1. U.S. Code
  2. title 7
  3. chapter 6
  4. subchapter II
  5. § 136m

Collapse to view only § 136m. Indemnities

§§ 135 to 135k. Omitted

CITE AS: 7 USC 135 to 135k

§ 136. DefinitionsFor purposes of this subchapter—
(a) Active ingredientThe term “active ingredient” means—
(1) in the case of a pesticide other than a plant regulator, defoliant, desiccant, or nitrogen stabilizer, an ingredient which will prevent, destroy, repel, or mitigate any pest;
(2) in the case of a plant regulator, an ingredient which, through physiological action, will accelerate or retard the rate of growth or rate of maturation or otherwise alter the behavior of ornamental or crop plants or the product thereof;
(3) in the case of a defoliant, an ingredient which will cause the leaves or foliage to drop from a plant;
(4) in the case of a desiccant, an ingredient which will artificially accelerate the drying of plant tissue; and
(5) in the case of a nitrogen stabilizer, an ingredient which will prevent or hinder the process of nitrification, denitrification, ammonia volatilization, or urease production through action affecting soil bacteria.
(b) Administrator
(c) AdulteratedThe term “adulterated” applies to any pesticide if—
(1) its strength or purity falls below the professed standard of quality as expressed on its labeling under which it is sold;
(2) any substance has been substituted wholly or in part for the pesticide; or
(3) any valuable constituent of the pesticide has been wholly or in part abstracted.
(d) Animal
(e) Certified applicator, etc.
(1) Certified applicator
(2) Private applicator
(3) Commercial applicator
(4) Under the direct supervision of a certified applicator
(f) Defoliant
(g) Desiccant
(h) Device
(i) District court
(j) Environment
(k) Fungus
(l) Imminent hazard
(m) Inert ingredient
(n) Ingredient statementThe term “ingredient statement” means a statement which contains—
(1) the name and percentage of each active ingredient, and the total percentage of all inert ingredients, in the pesticide; and
(2) if the pesticide contains arsenic in any form, a statement of the percentages of total and water soluble arsenic, calculated as elementary arsenic.
(o) Insect
(p) Label and labeling
(1) Label
(2) LabelingThe term “labeling” means all labels and all other written, printed, or graphic matter—
(A) accompanying the pesticide or device at any time; or
(B) to which reference is made on the label or in literature accompanying the pesticide or device, except to current official publications of the Environmental Protection Agency, the United States Departments of Agriculture and Interior, the Department of Health and Human Services, State experiment stations, State agricultural colleges, and other similar Federal or State institutions or agencies authorized by law to conduct research in the field of pesticides.
(q) Misbranded
(1) A pesticide is misbranded if—
(A) its labeling bears any statement, design, or graphic representation relative thereto or to its ingredients which is false or misleading in any particular;
(B) it is contained in a package or other container or wrapping which does not conform to the standards established by the Administrator pursuant to section 136w(c)(3) of this title;
(C) it is an imitation of, or is offered for sale under the name of, another pesticide;
(D) its label does not bear the registration number assigned under section 136e of this title to each establishment in which it was produced;
(E) any word, statement, or other information required by or under authority of this subchapter to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or graphic matter in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use;
(F) the labeling accompanying it does not contain directions for use which are necessary for effecting the purpose for which the product is intended and if complied with, together with any requirements imposed under section 136a(d) of this title, are adequate to protect health and the environment;
(G) the label does not contain a warning or caution statement which may be necessary and if complied with, together with any requirements imposed under section 136a(d) of this title, is adequate to protect health and the environment; or
(H) in the case of a pesticide not registered in accordance with section 136a of this title and intended for export, the label does not contain, in words prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or graphic matter in the labeling) as to render it likely to be noted by the ordinary individual under customary conditions of purchase and use, the following: “Not Registered for Use in the United States of America”.
(2) A pesticide is misbranded if—
(A) the label does not bear an ingredient statement on that part of the immediate container (and on the outside container or wrapper of the retail package, if there be one, through which the ingredient statement on the immediate container cannot be clearly read) which is presented or displayed under customary conditions of purchase, except that a pesticide is not misbranded under this subparagraph if—
(i) the size or form of the immediate container, or the outside container or wrapper of the retail package, makes it impracticable to place the ingredient statement on the part which is presented or displayed under customary conditions of purchase; and
(ii) the ingredient statement appears prominently on another part of the immediate container, or outside container or wrapper, permitted by the Administrator;
(B) the labeling does not contain a statement of the use classification under which the product is registered;
(C) there is not affixed to its container, and to the outside container or wrapper of the retail package, if there be one, through which the required information on the immediate container cannot be clearly read, a label bearing—
(i) the name and address of the producer, registrant, or person for whom produced;
(ii) the name, brand, or trademark under which the pesticide is sold;
(iii) the net weight or measure of the span, except that the Administrator may permit reasonable variations; and
(iv) when required by regulation of the Administrator to effectuate the purposes of this subchapter, the registration number assigned to the pesticide under this subchapter, and the use classification; and
(D) the pesticide contains any substance or substances in quantities highly toxic to man, unless the label shall bear, in addition to any other matter required by this subchapter—
(i) the skull and crossbones;
(ii) the word “poison” prominently in red on a background of distinctly contrasting color; and
(iii) a statement of a practical treatment (first aid or otherwise) in case of poisoning by the pesticide.
(r) Nematode
(s) Person
(t) Pest
(u) Pesticide
(v) Plant regulator
(w) Producer and produce
(x) Protect health and the environment
(y) Registrant
(z) Registration
(aa) State
(bb) Unreasonable adverse effects on the environment
(cc) Weed
(dd) Establishment
(ee) To use any registered pesticide in a manner inconsistent with its labeling
(ff) Outstanding data requirement
(1) In generalThe term “outstanding data requirement” means a requirement for any study, information, or data that is necessary to make a determination under section 136a(c)(5) of this title and which study, information, or data—
(A) has not been submitted to the Administrator; or
(B) if submitted to the Administrator, the Administrator has determined must be resubmitted because it is not valid, complete, or adequate to make a determination under section 136a(c)(5) of this title and the regulations and guidelines issued under such section.
(2) Factors
(gg) To distribute or sell
(hh) Nitrogen stabilizerThe term “nitrogen stabilizer” means any substance or mixture of substances intended for preventing or hindering the process of nitrification, denitrification, ammonia volatilization, or urease production through action upon soil bacteria. Such term shall not include—
(1) dicyandiamide;
(2) ammonium thiosulfate; or
(3) any substance or mixture of substances.—2
2 So in original. Period probably should not appear.
(A) that was not registered pursuant to section 136a of this title prior to January 1, 1992; and
(B) that was in commercial agronomic use prior to January 1, 1992, with respect to which after January 1, 1992, the distributor or seller of the substance or mixture has made no specific claim of prevention or hindering of the process of nitrification, denitrification, ammonia volatilization 3
3 So in original. Probably should be followed by “, or”.
urease production regardless of the actual use or purpose for, or future use or purpose for, the substance or mixture.
Statements made in materials required to be submitted to any State legislative or regulatory authority, or required by such authority to be included in the labeling or other literature accompanying any such substance or mixture shall not be deemed a specific claim within the meaning of this subsection.
(jj)4
4 So in original. No subsec. (ii) was enacted.
Maintenance applicator
(kk) Service technician
(ll) Minor useThe term “minor use” means the use of a pesticide on an animal, on a commercial agricultural crop or site, or for the protection of public health where—
(1) the total United States acreage for the crop is less than 300,000 acres, as determined by the Secretary of Agriculture; or
(2) the Administrator, in consultation with the Secretary of Agriculture, determines that, based on information provided by an applicant for registration or a registrant, the use does not provide sufficient economic incentive to support the initial registration or continuing registration of a pesticide for such use and—
(A) there are insufficient efficacious alternative registered pesticides available for the use;
(B) the alternatives to the pesticide use pose greater risks to the environment or human health;
(C) the minor use pesticide plays or will play a significant part in managing pest resistance; or
(D) the minor use pesticide plays or will play a significant part in an integrated pest management program.
The status as a minor use under this subsection shall continue as long as the Administrator has not determined that, based on existing data, such use may cause an unreasonable adverse effect on the environment and the use otherwise qualifies for such status.
(mm) Antimicrobial pesticide
(1) In generalThe term “antimicrobial pesticide” means a pesticide that—
(A) is intended to—
(i) disinfect, sanitize, reduce, or mitigate growth or development of microbiological organisms; or
(ii) protect inanimate objects, industrial processes or systems, surfaces, water, or other chemical substances from contamination, fouling, or deterioration caused by bacteria, viruses, fungi, protozoa, algae, or slime; and
(B) in the intended use is exempt from, or otherwise not subject to, a tolerance under section 346a of title 21 or a food additive regulation under section 348 of title 21.
(2) Excluded productsThe term “antimicrobial pesticide” does not include—
(A) a wood preservative or antifouling paint product for which a claim of pesticidal activity other than or in addition to an activity described in paragraph (1) is made;
(B) an agricultural fungicide product; or
(C) an aquatic herbicide product.
(3) Included products
(nn) Public health pesticide
(oo) Vector
(June 25, 1947, ch. 125, § 2, as added Pub. L. 92–516, § 2, Oct. 21, 1972, 86 Stat. 975; amended Pub. L. 93–205, § 13(f), Dec. 28, 1973, 87 Stat. 903; Pub. L. 94–140, § 9, Nov. 28, 1975, 89 Stat. 754; Pub. L. 95–396, § 1, Sept. 30, 1978, 92 Stat. 819; Pub. L. 100–532, title I, § 101, title VI, § 601(a), title VIII, § 801(a), Oct. 25, 1988, 102 Stat. 2655, 2677, 2679; Pub. L. 102–237, title X, § 1006(a)(1), (2), (b)(3)(A), (B), Dec. 13, 1991, 105 Stat. 1894, 1895; Pub. L. 104–170, title I, §§ 105(a), 120, title II, §§ 210(a), 221, 230, title III, § 304, Aug. 3, 1996, 110 Stat. 1490, 1492, 1493, 1502, 1508, 1512.)

CITE AS: 7 USC 136

§ 136a. Registration of pesticides
(a) Requirement of registration
(b) ExemptionsA pesticide which is not registered with the Administrator may be transferred if—
(1) the transfer is from one registered establishment to another registered establishment operated by the same producer solely for packaging at the second establishment or for use as a constituent part of another pesticide produced at the second establishment; or
(2) the transfer is pursuant to and in accordance with the requirements of an experimental use permit.
(c) Procedure for registration
(1) Statement requiredEach applicant for registration of a pesticide shall file with the Administrator a statement which includes—
(A) the name and address of the applicant and of any other person whose name will appear on the labeling;
(B) the name of the pesticide;
(C) a complete copy of the labeling of the pesticide, a statement of all claims to be made for it, and any directions for its use;
(D) the complete formula of the pesticide;
(E) a request that the pesticide be classified for general use or for restricted use, or for both; and
(F) except as otherwise provided in paragraph (2)(D), if requested by the Administrator, a full description of the tests made and the results thereof upon which the claims are based, or alternatively a citation to data that appear in the public literature or that previously had been submitted to the Administrator and that the Administrator may consider in accordance with the following provisions:
(i) With respect to pesticides containing active ingredients that are initially registered under this subchapter after September 30, 1978, data submitted to support the application for the original registration of the pesticide, or an application for an amendment adding any new use to the registration and that pertains solely to such new use, shall not, without the written permission of the original data submitter, be considered by the Administrator to support an application by another person during a period of ten years following the date the Administrator first registers the pesticide, except that such permission shall not be required in the case of defensive data.
(ii) The period of exclusive data use provided under clause (i) shall be extended 1 additional year for each 3 minor uses registered after August 3, 1996, and within 7 years of the commencement of the exclusive use period, up to a total of 3 additional years for all minor uses registered by the Administrator if the Administrator, in consultation with the Secretary of Agriculture, determines that, based on information provided by an applicant for registration or a registrant, that—(I) there are insufficient efficacious alternative registered pesticides available for the use;(II) the alternatives to the minor use pesticide pose greater risks to the environment or human health;(III) the minor use pesticide plays or will play a significant part in managing pest resistance; or(IV) the minor use pesticide plays or will play a significant part in an integrated pest management program.
 The registration of a pesticide for a minor use on a crop grouping established by the Administrator shall be considered for purposes of this clause 1 minor use for each representative crop for which data are provided in the crop grouping. Any additional exclusive use period under this clause shall be modified as appropriate or terminated if the registrant voluntarily cancels the product or deletes from the registration the minor uses which formed the basis for the extension of the additional exclusive use period or if the Administrator determines that the registrant is not actually marketing the product for such minor uses.
(iii) Except as otherwise provided in clause (i), with respect to data submitted after December 31, 1969, by an applicant or registrant to support an application for registration, experimental use permit, or amendment adding a new use to an existing registration, to support or maintain in effect an existing registration, or for reregistration, the Administrator may, without the permission of the original data submitter, consider any such item of data in support of an application by any other person (hereinafter in this subparagraph referred to as the “applicant”) within the fifteen-year period following the date the data were originally submitted only if the applicant has made an offer to compensate the original data submitter and submitted such offer to the Administrator accompanied by evidence of delivery to the original data submitter of the offer. The terms and amount of compensation may be fixed by agreement between the original data submitter and the applicant, or, failing such agreement, binding arbitration under this subparagraph. If, at the end of ninety days after the date of delivery to the original data submitter of the offer to compensate, the original data submitter and the applicant have neither agreed on the amount and terms of compensation nor on a procedure for reaching an agreement on the amount and terms of compensation, either person may initiate binding arbitration proceedings by requesting the Federal Mediation and Conciliation Service to appoint an arbitrator from the roster of arbitrators maintained by such Service. The procedure and rules of the Service shall be applicable to the selection of such arbitrator and to such arbitration proceedings, and the findings and determination of the arbitrator shall be final and conclusive, and no official or court of the United States shall have power or jurisdiction to review any such findings and determination, except for fraud, misrepresentation, or other misconduct by one of the parties to the arbitration or the arbitrator where there is a verified complaint with supporting affidavits attesting to specific instances of such fraud, misrepresentation, or other misconduct. The parties to the arbitration shall share equally in the payment of the fee and expenses of the arbitrator. If the Administrator determines that an original data submitter has failed to participate in a procedure for reaching an agreement or in an arbitration proceeding as required by this subparagraph, or failed to comply with the terms of an agreement or arbitration decision concerning compensation under this subparagraph, the original data submitter shall forfeit the right to compensation for the use of the data in support of the application. Notwithstanding any other provision of this subchapter, if the Administrator determines that an applicant has failed to participate in a procedure for reaching an agreement or in an arbitration proceeding as required by this subparagraph, or failed to comply with the terms of an agreement or arbitration decision concerning compensation under this subparagraph, the Administrator shall deny the application or cancel the registration of the pesticide in support of which the data were used without further hearing. Before the Administrator takes action under either of the preceding two sentences, the Administrator shall furnish to the affected person, by certified mail, notice of intent to take action and allow fifteen days from the date of delivery of the notice for the affected person to respond. If a registration is denied or canceled under this subparagraph, the Administrator may make such order as the Administrator deems appropriate concerning the continued sale and use of existing stocks of such pesticide. Registration action by the Administrator shall not be delayed pending the fixing of compensation.
(iv) After expiration of any period of exclusive use and any period for which compensation is required for the use of an item of data under clauses (i), (ii), and (iii), the Administrator may consider such item of data in support of an application by any other applicant without the permission of the original data submitter and without an offer having been received to compensate the original data submitter for the use of such item of data.
(v) The period of exclusive use provided under clause (ii) shall not take effect until 1 year after August 3, 1996, except where an applicant or registrant is applying for the registration of a pesticide containing an active ingredient not previously registered.
(vi) With respect to data submitted after August 3, 1996, by an applicant or registrant to support an amendment adding a new use to an existing registration that does not retain any period of exclusive use, if such data relates solely to a minor use of a pesticide, such data shall not, without the written permission of the original data submitter, be considered by the Administrator to support an application for a minor use by another person during the period of 10 years following the date of submission of such data. The applicant or registrant at the time the new minor use is requested shall notify the Administrator that to the best of their knowledge the exclusive use period for the pesticide has expired and that the data pertaining solely to the minor use of a pesticide is eligible for the provisions of this paragraph. If the minor use registration which is supported by data submitted pursuant to this subsection is voluntarily canceled or if such data are subsequently used to support a nonminor use, the data shall no longer be subject to the exclusive use provisions of this clause but shall instead be considered by the Administrator in accordance with the provisions of clause (i), as appropriate.
(G) If the applicant is requesting that the registration or amendment to the registration of a pesticide be expedited, an explanation of the basis for the request must be submitted, in accordance with paragraph (10) of this subsection.
(2) Data in support of registration
(A) In general
(B) Additional data
(i) If the Administrator determines that additional data are required to maintain in effect an existing registration of a pesticide, the Administrator shall notify all existing registrants of the pesticide to which the determination relates and provide a list of such registrants to any interested person.
(ii) Each registrant of such pesticide shall provide evidence within ninety days after receipt of notification that it is taking appropriate steps to secure the additional data that are required. Two or more registrants may agree to develop jointly, or to share in the cost of developing, such data if they agree and advise the Administrator of their intent within ninety days after notification. Any registrant who agrees to share in the cost of producing the data shall be entitled to examine and rely upon such data in support of maintenance of such registration. The Administrator shall issue a notice of intent to suspend the registration of a pesticide in accordance with the procedures prescribed by clause (iv) if a registrant fails to comply with this clause.
(iii) If, at the end of sixty days after advising the Administrator of their agreement to develop jointly, or share in the cost of developing, data, the registrants have not further agreed on the terms of the data development arrangement or on a procedure for reaching such agreement, any of such registrants may initiate binding arbitration proceedings by requesting the Federal Mediation and Conciliation Service to appoint an arbitrator from the roster of arbitrators maintained by such Service. The procedure and rules of the Service shall be applicable to the selection of such arbitrator and to such arbitration proceedings, and the findings and determination of the arbitrator shall be final and conclusive, and no official or court of the United States shall have power or jurisdiction to review any such findings and determination, except for fraud, misrepresentation, or other misconduct by one of the parties to the arbitration or the arbitrator where there is a verified complaint with supporting affidavits attesting to specific instances of such fraud, misrepresentation, or other misconduct. All parties to the arbitration shall share equally in the payment of the fee and expenses of the arbitrator. The Administrator shall issue a notice of intent to suspend the registration of a pesticide in accordance with the procedures prescribed by clause (iv) if a registrant fails to comply with this clause.
(iv) Notwithstanding any other provision of this subchapter, if the Administrator determines that a registrant, within the time required by the Administrator, has failed to take appropriate steps to secure the data required under this subparagraph, to participate in a procedure for reaching agreement concerning a joint data development arrangement under this subparagraph or in an arbitration proceeding as required by this subparagraph, or to comply with the terms of an agreement or arbitration decision concerning a joint data development arrangement under this subparagraph, the Administrator may issue a notice of intent to suspend such registrant’s registration of the pesticide for which additional data is required. The Administrator may include in the notice of intent to suspend such provisions as the Administrator deems appropriate concerning the continued sale and use of existing stocks of such pesticide. Any suspension proposed under this subparagraph shall become final and effective at the end of thirty days from receipt by the registrant of the notice of intent to suspend, unless during that time a request for hearing is made by a person adversely affected by the notice or the registrant has satisfied the Administrator that the registrant has complied fully with the requirements that served as a basis for the notice of intent to suspend. If a hearing is requested, a hearing shall be conducted under section 136d(d) of this title. The only matters for resolution at that hearing shall be whether the registrant has failed to take the action that served as the basis for the notice of intent to suspend the registration of the pesticide for which additional data is required, and whether the Administrator’s determination with respect to the disposition of existing stocks is consistent with this subchapter. If a hearing is held, a decision after completion of such hearing shall be final. Notwithstanding any other provision of this subchapter, a hearing shall be held and a determination made within seventy-five days after receipt of a request for such hearing. Any registration suspended under this subparagraph shall be reinstated by the Administrator if the Administrator determines that the registrant has complied fully with the requirements that served as a basis for the suspension of the registration.
(v) Any data submitted under this subparagraph shall be subject to the provisions of paragraph (1)(D). Whenever such data are submitted jointly by two or more registrants, an agent shall be agreed on at the time of the joint submission to handle any subsequent data compensation matters for the joint submitters of such data.
(vi) Upon the request of a registrant the Administrator shall, in the case of a minor use, extend the deadline for the production of residue chemistry data under this subparagraph for data required solely to support that minor use until the final deadline for submission of data under section 136a–1 of this title for the other uses of the pesticide established as of August 3, 1996, if—(I) the data to support other uses of the pesticide on a food are being provided;(II) the registrant, in submitting a request for such an extension, provides a schedule, including interim dates to measure progress, to assure that the data production will be completed before the expiration of the extension period;(III) the Administrator has determined that such extension will not significantly delay the Administrator’s schedule for issuing a reregistration eligibility determination required under section 136a–1 of this title; and(IV) the Administrator has determined that based on existing data, such extension would not significantly increase the risk of any unreasonable adverse effect on the environment. If the Administrator grants an extension under this clause, the Administrator shall monitor the development of the data and shall ensure that the registrant is meeting the schedule for the production of the data. If the Administrator determines that the registrant is not meeting or has not met the schedule for the production of such data, the Administrator may proceed in accordance with clause (iv) regarding the continued registration of the affected products with the minor use and shall inform the public of such action. Notwithstanding the provisions of this clause, the Administrator may take action to modify or revoke the extension under this clause if the Administrator determines that the extension for the minor use may cause an unreasonable adverse effect on the environment. In such circumstance, the Administrator shall provide, in writing to the registrant, a notice revoking the extension of time for submission of data. Such data shall instead be due in accordance with the date established by the Administrator for the submission of the data.
(vii) If the registrant does not commit to support a specific minor use of the pesticide, but is supporting and providing data in a timely and adequate fashion to support uses of the pesticide on a food, or if all uses of the pesticide are nonfood uses and the registrant does not commit to support a specific minor use of the pesticide but is supporting and providing data in a timely and adequate fashion to support other nonfood uses of the pesticide, the Administrator, at the written request of the registrant, shall not take any action pursuant to this clause in regard to such unsupported minor use until the final deadline established as of August 3, 1996, for the submission of data under section 136a–1 of this title for the supported uses identified pursuant to this clause unless the Administrator determines that the absence of the data is significant enough to cause human health or environmental concerns. On the basis of such determination, the Administrator may refuse the request for extension by the registrant. Upon receipt of the request from the registrant, the Administrator shall publish in the Federal Register a notice of the receipt of the request and the effective date upon which the uses not being supported will be voluntarily deleted from the registration pursuant to section 136d(f)(1) of this title. If the Administrator grants an extension under this clause, the Administrator shall monitor the development of the data for the uses being supported and shall ensure that the registrant is meeting the schedule for the production of such data. If the Administrator determines that the registrant is not meeting or has not met the schedule for the production of such data, the Administrator may proceed in accordance with clause (iv) of this subparagraph regarding the continued registration of the affected products with the minor and other uses and shall inform the public of such action in accordance with section 136d(f)(2) of this title. Notwithstanding the provisions of this clause, the Administrator may deny, modify, or revoke the temporary extension under this subparagraph if the Administrator determines that the continuation of the minor use may cause an unreasonable adverse effect on the environment. In the event of modification or revocation, the Administrator shall provide, in writing, to the registrant a notice revoking the temporary extension and establish a new effective date by which the minor use shall be deleted from the registration.
(viii)(I) If data required to support registration of a pesticide under subparagraph (A) is requested by a Federal or State regulatory authority, the Administrator shall, to the extent practicable, coordinate data requirements, test protocols, timetables, and standards of review and reduce burdens and redundancy caused to the registrant by multiple requirements on the registrant.(II) The Administrator may enter into a cooperative agreement with a State to carry out subclause (I).(III) Not later than 1 year after August 3, 1996, the Administrator shall develop a process to identify and assist in alleviating future disparities between Federal and State data requirements.
(C) Simplified procedures
(D) ExemptionNo applicant for registration of a pesticide who proposes to purchase a registered pesticide from another producer in order to formulate such purchased pesticide into the pesticide that is the subject of the application shall be required to—
(i) submit or cite data pertaining to such purchased product; or
(ii) offer to pay reasonable compensation otherwise required by paragraph (1)(D) of this subsection for the use of any such data.
(E) Minor use waiverIn handling the registration of a pesticide for a minor use, the Administrator may waive otherwise applicable data requirements if the Administrator determines that the absence of such data will not prevent the Administrator from determining—
(i) the incremental risk presented by the minor use of the pesticide; and
(ii) that such risk, if any, would not be an unreasonable adverse effect on the environment.
(3) Application
(A) In general
(B) Identical or substantially similar
(i) The Administrator shall, as expeditiously as possible, review and act on any application received by the Administrator that—(I) proposes the initial or amended registration of an end-use pesticide that, if registered as proposed, would be identical or substantially similar in composition and labeling to a currently-registered pesticide identified in the application, or that would differ in composition and labeling from such currently-registered pesticide only in ways that would not significantly increase the risk of unreasonable adverse effects on the environment; or(II) proposes an amendment to the registration of a registered pesticide that does not require scientific review of data.
(ii) In expediting the review of an application for an action described in clause (i), the Administrator shall—(I) review the application in accordance with section 136w–8(f)(4)(B) of this title and, if the application is found to be incomplete, reject the application;(II) not later than the applicable decision review time established pursuant to section 136w–8(f)(4)(B) of this title, or, if no review time is established, not later than 90 days after receiving a complete application, notify the registrant if the application has been granted or denied; and(III) if the application is denied, notify the registrant in writing of the specific reasons for the denial of the application.
(C) Minor use registration
(i) The Administrator shall, as expeditiously as possible, review and act on any complete application—(I) that proposes the initial registration of a new pesticide active ingredient if the active ingredient is proposed to be registered solely for minor uses, or proposes a registration amendment solely for minor uses to an existing registration; or(II) for a registration or a registration amendment that proposes significant minor uses.
(ii) For the purposes of clause (i)—(I) the term “as expeditiously as possible” means that the Administrator shall, to the greatest extent practicable, complete a review and evaluation of all data, submitted with a complete application, within 12 months after the submission of the complete application, and the failure of the Administrator to complete such a review and evaluation under clause (i) shall not be subject to judicial review; and(II) the term “significant minor uses” means 3 or more minor uses proposed for every nonminor use, a minor use that would, in the judgment of the Administrator, serve as a replacement for any use which has been canceled in the 5 years preceding the receipt of the application, or a minor use that in the opinion of the Administrator would avoid the reissuance of an emergency exemption under section 136p of this title for that minor use.
(D) Adequate time for submission of minor use data
(4) Notice of application
(5) Approval of registrationThe Administrator shall register a pesticide if the Administrator determines that, when considered with any restrictions imposed under subsection (d)—
(A) its composition is such as to warrant the proposed claims for it;
(B) its labeling and other material required to be submitted comply with the requirements of this subchapter;
(C) it will perform its intended function without unreasonable adverse effects on the environment; and
(D) when used in accordance with widespread and commonly recognized practice it will not generally cause unreasonable adverse effects on the environment.
The Administrator shall not make any lack of essentiality a criterion for denying registration of any pesticide. Where two pesticides meet the requirements of this paragraph, one should not be registered in preference to the other. In considering an application for the registration of a pesticide, the Administrator may waive data requirements pertaining to efficacy, in which event the Administrator may register the pesticide without determining that the pesticide’s composition is such as to warrant proposed claims of efficacy. If a pesticide is found to be efficacious by any State under section 136v(c) of this title, a presumption is established that the Administrator shall waive data requirements pertaining to efficacy for use of the pesticide in such State.
(6) Denial of registration
(7) Registration under special circumstancesNotwithstanding the provisions of paragraph (5)—
(A) The Administrator may conditionally register or amend the registration of a pesticide if the Administrator determines that (i) the pesticide and proposed use are identical or substantially similar to any currently registered pesticide and use thereof, or differ only in ways that would not significantly increase the risk of unreasonable adverse effects on the environment, and (ii) approving the registration or amendment in the manner proposed by the applicant would not significantly increase the risk of any unreasonable adverse effect on the environment. An applicant seeking conditional registration or amended registration under this subparagraph shall submit such data as would be required to obtain registration of a similar pesticide under paragraph (5). If the applicant is unable to submit an item of data because it has not yet been generated, the Administrator may register or amend the registration of the pesticide under such conditions as will require the submission of such data not later than the time such data are required to be submitted with respect to similar pesticides already registered under this subchapter.
(B) The Administrator may conditionally amend the registration of a pesticide to permit additional uses of such pesticide notwithstanding that data concerning the pesticide may be insufficient to support an unconditional amendment, if the Administrator determines that (i) the applicant has submitted satisfactory data pertaining to the proposed additional use, and (ii) amending the registration in the manner proposed by the applicant would not significantly increase the risk of any unreasonable adverse effect on the environment. Notwithstanding the foregoing provisions of this subparagraph, no registration of a pesticide may be amended to permit an additional use of such pesticide if the Administrator has issued a notice stating that such pesticide, or any ingredient thereof, meets or exceeds risk criteria associated in whole or in part with human dietary exposure enumerated in regulations issued under this subchapter, and during the pendency of any risk-benefit evaluation initiated by such notice, if (I) the additional use of such pesticide involves a major food or feed crop, or (II) the additional use of such pesticide involves a minor food or feed crop and the Administrator determines, with the concurrence of the Secretary of Agriculture, there is available an effective alternative pesticide that does not meet or exceed such risk criteria. An applicant seeking amended registration under this subparagraph shall submit such data as would be required to obtain registration of a similar pesticide under paragraph (5). If the applicant is unable to submit an item of data (other than data pertaining to the proposed additional use) because it has not yet been generated, the Administrator may amend the registration under such conditions as will require the submission of such data not later than the time such data are required to be submitted with respect to similar pesticides already registered under this subchapter.
(C) The Administrator may conditionally register a pesticide containing an active ingredient not contained in any currently registered pesticide for a period reasonably sufficient for the generation and submission of required data (which are lacking because a period reasonably sufficient for generation of the data has not elapsed since the Administrator first imposed the data requirement) on the condition that by the end of such period the Administrator receives such data and the data do not meet or exceed risk criteria enumerated in regulations issued under this subchapter, and on such other conditions as the Administrator may prescribe. A conditional registration under this subparagraph shall be granted only if the Administrator determines that use of the pesticide during such period will not cause any unreasonable adverse effect on the environment, and that use of the pesticide is in the public interest.
(8) Interim administrative review
(9) Labeling
(A) Additional statements
(B) Requirements
(C) Notification and disapproval
(i) NotificationA registration may be modified under subparagraph (A) if—(I) the registrant notifies the Administrator in writing not later than 60 days prior to distribution or sale of a product bearing the modified labeling; and(II) the Administrator does not disapprove of the modification under clause (ii).
(ii) Disapproval
(iii) Restriction on sale
(iv) Objection
(v) Final action
(D) Use dilutionThe label or labeling required under this subchapter for an antimicrobial pesticide that is or may be diluted for use may have a different statement of caution or protective measures for use of the recommended diluted solution of the pesticide than for use of a concentrate of the pesticide if the Administrator determines that—
(i) adequate data have been submitted to support the statement proposed for the diluted solution uses; and
(ii) the label or labeling provides adequate protection for exposure to the diluted solution of the pesticide.
(10) Expedited registration of pesticides
(A) Not later than 1 year after August 3, 1996, the Administrator shall, utilizing public comment, develop procedures and guidelines, and expedite the review of an application for registration of a pesticide or an amendment to a registration that satisfies such guidelines.
(B) Any application for registration or an amendment, including biological and conventional pesticides, will be considered for expedited review under this paragraph. An application for registration or an amendment shall qualify for expedited review if use of the pesticide proposed by the application may reasonably be expected to accomplish 1 or more of the following:
(i) Reduce the risks of pesticides to human health.
(ii) Reduce the risks of pesticides to nontarget organisms.
(iii) Reduce the potential for contamination of groundwater, surface water, or other valued environmental resources.
(iv) Broaden the adoption of integrated pest management strategies, or make such strategies more available or more effective.
(C) The Administrator, not later than 30 days after receipt of an application for expedited review, shall notify the applicant whether the application is complete. If it is found to be incomplete, the Administrator may either reject the request for expedited review or ask the applicant for additional information to satisfy the guidelines developed under subparagraph (A).
(11) Interagency working group
(A) Definition of covered agencyIn this paragraph, the term “covered agency” means any of the following:
(i) The Department of Agriculture.
(ii) The Department of Commerce.
(iii) The Department of the Interior.
(iv) The Council on Environmental Quality.
(v) The Environmental Protection Agency.
(B) Establishment
(C) DutiesThe interagency working group established under subparagraph (B) shall—
(i) analyze relevant Federal law (including regulations) and case law for purposes of providing an outline of the legal and regulatory framework for the consultation process referred to in that subparagraph, including—(I) requirements under this subchapter and the Endangered Species Act of 1973 (16 U.S.C. 1531 et seq.);(II) Federal case law regarding the intersection of this subchapter and the Endangered Species Act of 1973 (16 U.S.C. 1531 et seq.); and(III) Federal regulations relating to the pesticide consultation process;
(ii) provide advice regarding methods of—(I) defining the scope of actions of the covered agencies that are subject to the consultation requirement referred to in subparagraph (B); and(II) properly identifying and classifying effects of actions of the covered agencies with respect to that consultation requirement;
(iii) identify the obligations and limitations under Federal law of each covered agency for purposes of providing a legal and regulatory framework for developing the recommendations referred to in subparagraph (B);
(iv) review practices for the consultation referred to in subparagraph (B) to identify problem areas, areas for improvement, and best practices for conducting that consultation among the covered agencies;
(v) develop scientific and policy approaches to increase the accuracy and timeliness of the process for that consultation, in accordance with requirements of this subchapter and the Endangered Species Act of 1973 (16 U.S.C. 1531 et seq.), including—(I) processes to efficiently share data and coordinate analyses among the Department of Agriculture, the Department of Commerce, the Department of the Interior, and the Environmental Protection Agency;(II) a streamlined process for identifying which actions require no consultation, informal consultation, or formal consultation;(III) an approach that will provide clarity with respect to what constitutes the best scientific and commercial data available in the fields of pesticide use and ecological risk assessment, pursuant to section 7(a)(2) of the Endangered Species Act of 1973 (16 U.S.C. 1536(a)(2)); and(IV) approaches that enable the Environmental Protection Agency to better assist the Department of the Interior and the Department of Commerce in carrying out obligations under that section in a timely and efficient manner; and
(vi) propose and implement a strategy to implement approaches to consultations under the Endangered Species Act of 1973 (16 U.S.C. 1531 et seq.) and document that strategy in a memorandum of understanding, revised regulations, or another appropriate format to promote durable cooperation among the covered agencies.
(D) Reports
(i) Progress reports(I) In general(II) RequirementsThe report under this clause shall—(aa) reflect the perspectives of each covered agency; and(bb) identify areas of new consensus and continuing topics of disagreement and debate.
(ii) Results(I) In generalNot later than 1 year after December 20, 2018, the Administrator, in coordination with the head of each other covered agency, shall submit to the Committee on Agriculture of the House of Representatives and the Committee on Agriculture, Nutrition, and Forestry of the Senate a report describing—(aa) the recommendations developed under subparagraph (B); and(bb) plans for implementation of those recommendations.(II) RequirementsThe report under this clause shall—(aa) reflect the perspectives of each covered agency; and(bb) identify areas of consensus and continuing topics of disagreement and debate, if any.
(iii) ImplementationNot later than 1 year after the date of submission of the report under clause (i), the Administrator, in coordination with the head of each other covered agency, shall submit to the Committee on Agriculture of the House of Representatives and the Committee on Agriculture, Nutrition, and Forestry of the Senate a report describing—(I) the implementation of the recommendations referred to in that clause;(II) the extent to which that implementation improved the consultation process referred to in subparagraph (B); and(III) any additional recommendations for improvements to the process described in subparagraph (B).
(iv) Other reportsNot later than the date that is 180 days after the date of submission of the report under clause (iii), and not less frequently than once every 180 days thereafter during the 5-year period beginning on that date, the Administrator, in coordination with the head of each other covered agency, shall submit to the Committee on Agriculture of the House of Representatives and the Committee on Agriculture, Nutrition, and Forestry of the Senate a report describing—(I) the implementation of the recommendations referred to in that clause;(II) the extent to which that implementation improved the consultation process referred to in subparagraph (B); and(III) any additional recommendations for improvements to the process described in subparagraph (B).
(E) Consultation with private sectorIn carrying out the duties under this paragraph, the working group shall, as appropriate—
(i) consult with, representatives of interested industry stakeholders and nongovernmental organizations; and
(ii) take into consideration factors, such as actual and potential differences in interest between, and the views of, those stakeholders and organizations.
(F) Chapter 10 of title 5
(G) Savings clauseNothing in this paragraph supersedes any provision of—
(i) this subchapter; or
(ii) the Endangered Species Act of 1973 (16 U.S.C. 1531 et seq.), including the requirements under section 7 of that Act (16 U.S.C. 1536).
(d) Classification of pesticides
(1) Classification for general use, restricted use, or both
(A) As a part of the registration of a pesticide the Administrator shall classify it as being for general use or for restricted use. If the Administrator determines that some of the uses for which the pesticide is registered should be for general use and that other uses for which it is registered should be for restricted use, the Administrator shall classify it for both general use and restricted use. Pesticide uses may be classified by regulation on the initial classification, and registered pesticides may be classified prior to reregistration. If some of the uses of the pesticide are classified for general use, and other uses are classified for restricted use, the directions relating to its general uses shall be clearly separated and distinguished from those directions relating to its restricted uses. The Administrator may require that its packaging and labeling for restricted uses shall be clearly distinguishable from its packaging and labeling for general uses.
(B) If the Administrator determines that the pesticide, when applied in accordance with its directions for use, warnings and cautions and for the uses for which it is registered, or for one or more of such uses, or in accordance with a widespread and commonly recognized practice, will not generally cause unreasonable adverse effects on the environment, the Administrator will classify the pesticide, or the particular use or uses of the pesticide to which the determination applies, for general use.
(C) If the Administrator determines that the pesticide, when applied in accordance with its directions for use, warnings and cautions and for the uses for which it is registered, or for one or more of such uses, or in accordance with a widespread and commonly recognized practice, may generally cause, without additional regulatory restrictions, unreasonable adverse effects on the environment, including injury to the applicator, the Administrator shall classify the pesticide, or the particular use or uses to which the determination applies, for restricted use:
(i) If the Administrator classifies a pesticide, or one or more uses of such pesticide, for restricted use because of a determination that the acute dermal or inhalation toxicity of the pesticide presents a hazard to the applicator or other persons, the pesticide shall be applied for any use to which the restricted classification applies only by or under the direct supervision of a certified applicator.
(ii) If the Administrator classifies a pesticide, or one or more uses of such pesticide, for restricted use because of a determination that its use without additional regulatory restriction may cause unreasonable adverse effects on the environment, the pesticide shall be applied for any use to which the determination applies only by or under the direct supervision of a certified applicator, or subject to such other restrictions as the Administrator may provide by regulation. Any such regulation shall be reviewable in the appropriate court of appeals upon petition of a person adversely affected filed within 60 days of the publication of the regulation in final form.
(2) Change in classification
(3) Change in classification from restricted use to general use
(e) Products with same formulation and claims
(f) Miscellaneous
(1) Effect of change of labeling or formulation
(2) Registration not a defense
(3) Authority to consult other Federal agencies
(4) Mixtures of nitrogen stabilizers and fertilizer productsAny mixture or other combination of—
(A) 1 or more nitrogen stabilizers registered under this subchapter; and
(B) 1 or more fertilizer products,
shall not be subject to the provisions of this section or sections 136a–1, 136c, 136e, 136m, and 136o(a)(2) of this title if the mixture or other combination is accompanied by the labeling required under this subchapter for the nitrogen stabilizer contained in the mixture or other combination, the mixture or combination is mixed or combined in accordance with such labeling, and the mixture or combination does not contain any active ingredient other than the nitrogen stabilizer.
(5) Bilingual labeling
(A) Requirement
(i) In generalSubject to clause (ii), not later than the applicable deadline described in subparagraph (B), each registered pesticide product released for shipment shall include—(I) the translation of the parts of the labeling contained in the Spanish Translation Guide described in subparagraph (G) on the product container; or(II) a link to such translation via scannable technology or other electronic methods readily accessible on the product label.
(ii) ExceptionsNotwithstanding clause (i)—(I) an antimicrobial pesticide product may, in lieu of including a translation or a link under clause (i), provide a link to the safety data sheets in Spanish via scannable technology or other electronic methods readily accessible on the product label; or(II) a non-agricultural pesticide product that is not classified by the Administrator as restricted use under subsection (d)(1)(A) may, in lieu of including a translation or a link under clause (i), provide a link to the safety data sheets in Spanish via scannable technology or other electronic methods readily accessible on the product label.
(B) Deadlines for bilingual labeling
(i) Pesticide products classified as restricted use
(ii) Pesticide products not classified as restricted useIn the case of pesticide products not classified by the Administrator as restricted use under subsection (d)(1)(A), the deadline specified in this subparagraph shall be as follows:(I) Agricultural(aa) Acute Toxicity Category I(bb) Acute Toxicity Category II(II) Antimicrobial and non-agricultural(aa) Acute Toxicity Category I(bb) Acute Toxicity Category II(III) Other pesticide products
(C) Implementation
(i) Non-notification(I) In general(II) Non-notification procedure defined
(ii) Cooperation and consultation
(iii) End use labeling
(iv) Incorporation timeframeAfter initial translation deadlines provided in subparagraph (B), updates to the Spanish Translation Guide described in subparagraph (G) shall be incorporated into labeling on the earlier of—(I) in the case of agricultural use pesticide labels, as determined by the Administrator—(aa) 1 year after the date of publication of the updated Spanish Label Translation Guide described in subparagraph (G); or(bb) the released for shipment date specified on the EPA Stamped Approved Label after the pesticide label is next changed or amended following the date of publication of the updated Spanish Label Translation Guide described in subparagraph (G); and(II) in the case of antimicrobial and non-agricultural use pesticide labels, as determined by the Administrator—(aa) 2 years after the date of publication of the updated Spanish Label Translation Guide described in subparagraph (G); or(bb) the released for shipment date specified on the EPA Stamped Approved Label after the pesticide label is next changed or amended following the date of publication of the updated Spanish Label Translation Guide described in subparagraph (G).
(v) Notification of updates to the Spanish Translation Guide for Pesticide Labeling
(D) Accessibility of bilingual labeling for farm workers
(E) Plan
(F) Reporting
(G) Spanish Translation Guide described
(g) Registration review
(1) General rule
(A) Periodic review
(i) In general
(ii) Regulations
(iii) Initial registration reviewThe Administrator shall complete the registration review of each pesticide or pesticide case, which may be composed of 1 or more active ingredients and the products associated with the active ingredients, not later than the later of—(I)October 1, 2022; or(II) the date that is 15 years after the date on which the first pesticide containing a new active ingredient is registered.
(iv) Subsequent registration review
(v) Cancellation
(B) Docketing
(i) In generalSubject to clause (ii), after meeting with 1 or more individuals that are not government employees to discuss matters relating to a registration review, the Administrator shall place in the docket minutes of the meeting, a list of attendees, and any documents exchanged at the meeting, not later than the earlier of—(I) the date that is 45 days after the meeting; or(II) the date of issuance of the registration review decision.
(ii) Protected information
(C) Limitation
(2) Data
(A) Submission required
(B) Data submission, compensation, and exemption
(h) Registration requirements for antimicrobial pesticides
(1) Evaluation of processTo the maximum extent practicable consistent with the degrees of risk presented by an antimicrobial pesticide and the type of review appropriate to evaluate the risks, the Administrator shall identify and evaluate reforms to the antimicrobial registration process that would reduce review periods existing as of August 3, 1996, for antimicrobial pesticide product registration applications and applications for amended registration of antimicrobial pesticide products, including—
(A) new antimicrobial active ingredients;
(B) new antimicrobial end-use products;
(C) substantially similar or identical antimicrobial pesticides; and
(D) amendments to antimicrobial pesticide registrations.
(2) Review time period reduction goalEach reform identified under paragraph (1) shall be designed to achieve the goal of reducing the review period following submission of a complete application, consistent with the degree of risk, to a period of not more than—
(A) 540 days for a new antimicrobial active ingredient pesticide registration;
(B) 270 days for a new antimicrobial use of a registered active ingredient;
(C) 120 days for any other new antimicrobial product;
(D) 90 days for a substantially similar or identical antimicrobial product;
(E) 90 days for an amendment to an antimicrobial registration that does not require scientific review of data; and
(F) 120 days for an amendment to an antimicrobial registration that requires scientific review of data and that is not otherwise described in this paragraph.
(3) Implementation
(A) Proposed rulemaking
(i) Issuance
(ii) RequirementsProposed regulations issued under clause (i) shall—(I) define the various classes of antimicrobial use patterns, including household, industrial, and institutional disinfectants and sanitizing pesticides, preservatives, water treatment, and pulp and paper mill additives, and other such products intended to disinfect, sanitize, reduce, or mitigate growth or development of microbiological organisms, or protect inanimate objects, industrial processes or systems, surfaces, water, or other chemical substances from contamination, fouling, or deterioration caused by bacteria, viruses, fungi, protozoa, algae, or slime;(II) differentiate the types of review undertaken for antimicrobial pesticides;(III) conform the degree and type of review to the risks and benefits presented by antimicrobial pesticides and the function of review under this subchapter, considering the use patterns of the product, toxicity, expected exposure, and product type;(IV) ensure that the registration process is sufficient to maintain antimicrobial pesticide efficacy and that antimicrobial pesticide products continue to meet product performance standards and effectiveness levels for each type of label claim made; and(V) implement effective and reliable deadlines for process management.
(iii) Comments
(B) Final regulations
(i) Issuance
(ii) Failure to meet goal
(iii) RequirementsIn issuing final regulations, the Administrator shall—(I) consider the establishment of a certification process for regulatory actions involving risks that can be responsibly managed, consistent with the degree of risk, in the most cost-efficient manner;(II) consider the establishment of a certification process by approved laboratories as an adjunct to the review process;(III) use all appropriate and cost-effective review mechanisms, including—(aa) expanded use of notification and non-notification procedures;(bb) revised procedures for application review; and(cc) allocation of appropriate resources to ensure streamlined management of antimicrobial pesticide registrations; and(IV) clarify criteria for determination of the completeness of an application.
(C) Expedited review
(D) Alternative review periodsIf the final regulations to carry out this paragraph are not effective 630 days after August 3, 1996, until the final regulations become effective, the review period, beginning on the date of receipt by the Agency of a complete application, shall be—
(i) 2 years for a new antimicrobial active ingredient pesticide registration;
(ii) 1 year for a new antimicrobial use of a registered active ingredient;
(iii) 180 days for any other new antimicrobial product;
(iv) 90 days for a substantially similar or identical antimicrobial product;
(v) 90 days for an amendment to an antimicrobial registration that does not require scientific review of data; and
(vi) 120 days for an amendment to an antimicrobial registration that requires scientific review of data and that is not otherwise described in this subparagraph.
(E) Wood preservatives
(F) Notification
(i) In general
(ii) Final decision
(iii) Exemption
(iv) LimitationNotwithstanding clause (ii), the failure of the Administrator to notify an applicant for an amendment to a registration for an antimicrobial pesticide shall not be judicially reviewable in a Federal or State court if the amendment requires scientific review of data within—(I) the time period specified in subparagraph (D)(vi), in the absence of a final regulation under subparagraph (B); or(II) the time period specified in paragraph (2)(F), if adopted in a final regulation under subparagraph (B).
(4) Annual report
(A) Submission
(B) RequirementsA report submitted under subparagraph (A) shall include a description of—
(i) measures taken to reduce the backlog of pending registration applications;
(ii) progress toward achieving reforms under this subsection; and
(iii) recommendations to improve the activities of the Agency pertaining to antimicrobial registrations.
(June 25, 1947, ch. 125, § 3, as added Pub. L. 92–516, § 2, Oct. 21, 1972, 86 Stat. 979; amended Pub. L. 94–140, § 12, Nov. 28, 1975, 89 Stat. 755; Pub. L. 95–396, §§ 2(a), 3–8, Sept. 30, 1978, 92 Stat. 820, 824–827; Pub. L. 100–532, title I, §§ 102(b), 103, title VI, § 601(b)(1), title VIII, § 801(b), Oct. 25, 1988, 102 Stat. 2667, 2677, 2680; Pub. L. 101–624, title XIV, § 1492, Nov. 28, 1990, 104 Stat. 3628; Pub. L. 102–237, title X, § 1006(a)(3), (b)(1), (2), (c), Dec. 13, 1991, 105 Stat. 1894–1896; Pub. L. 104–170, title I, §§ 105(b), 106(b), title II, §§ 210(b), (c)(1), (d), (e), (f)(2), 222–224, 231, 250, Aug. 3, 1996, 110 Stat. 1491, 1494–1497, 1499, 1503, 1504, 1508, 1510; Pub. L. 108–199, div. G, title V, § 501(b), Jan. 23, 2004, 118 Stat. 419; Pub. L. 110–94, §§ 2, 3, Oct. 9, 2007, 121 Stat. 1000; Pub. L. 115–334, title X, § 10115, Dec. 20, 2018, 132 Stat. 4914; Pub. L. 117–286, § 4(a)(21), Dec. 27, 2022, 136 Stat. 4307; Pub. L. 117–328, div. HH, title VI, § 702, Dec. 29, 2022, 136 Stat. 5996.)

CITE AS: 7 USC 136a

§ 136a–1. Reregistration of registered pesticides
(a) General ruleThe Administrator shall reregister, in accordance with this section, each registered pesticide containing any active ingredient contained in any pesticide first registered before November 1, 1984, except for any pesticide as to which the Administrator has determined, after November 1, 1984, and before the effective date of this section, that—
(1) there are no outstanding data requirements; and
(2) the requirements of section 136a(c)(5) of this title have been satisfied.
(b) Reregistration phasesReregistrations of pesticides under this section shall be carried out in the following phases:
(1) The first phase shall include the listing under subsection (c) of the active ingredients of the pesticides that will be reregistered.
(2) The second phase shall include the submission to the Administrator under subsection (d) of notices by registrants respecting their intention to seek reregistration, identification by registrants of missing and inadequate data for such pesticides, and commitments by registrants to replace such missing or inadequate data within the applicable time period.
(3) The third phase shall include submission to the Administrator by registrants of the information required under subsection (e).
(4) The fourth phase shall include an independent, initial review by the Administrator under subsection (f) of submissions under phases two and three, identification of outstanding data requirements, and the issuance, as necessary, of requests for additional data.
(5) The fifth phase shall include the review by the Administrator under subsection (g) of data submitted for reregistration and appropriate regulatory action by the Administrator.
(c) Phase one
(1) Priority for reregistration
(A) are in use on or in food or feed and may result in postharvest residues;
(B) may result in residues of potential toxicological concern in potable ground water, edible fish, or shellfish;
(C) have been determined by the Administrator before the effective date of this section to have significant outstanding data requirements; or
(D) are used on crops, including in greenhouses and nurseries, where worker exposure is most likely to occur.
(2) Reregistration listsFor purposes of reregistration under this section, the Administrator shall by order—
(A) not later than 70 days after the effective date of this section, list pesticide active ingredients for which registration standards have been issued before such effective date;
(B) not later than 4 months after such effective date, list the first 150 pesticide active ingredients, as determined under paragraph (1);
(C) not later than 7 months after such effective date, list the second 150 pesticide active ingredients, as determined under paragraph (1); and
(D) not later than 10 months after such effective date, list the remainder of the pesticide active ingredients, as determined under paragraph (1).
Each list shall be published in the Federal Register.
(3) Judicial review
(4) Notice to registrants
(d) Phase two
(1) In general
(2) Notice of intent to seek or not to seek reregistration
(A) The registrant of a pesticide containing an active ingredient listed under subparagraph (B), (C), or (D) of subsection (c)(2) shall notify the Administrator by certified mail whether the registrant intends to seek or does not intend to seek reregistration of the pesticide.
(B) If a registrant submits a notice under subparagraph (A) of an intention not to seek reregistration of a pesticide, the Administrator shall publish a notice in the Federal Register stating that such a notice has been submitted.
(3) Missing or inadequate dataEach registrant of a pesticide that contains an active ingredient listed under subparagraph (B), (C), or (D) of subsection (c)(2) and for which the registrant submitted a notice under paragraph (2) of an intention to seek reregistration of such pesticide shall submit to the Administrator—
(A) in accordance with regulations issued by the Administrator under section 136a of this title, an identification of—
(i) all data that are required by regulation to support the registration of the pesticide with respect to such active ingredient;
(ii) data that were submitted by the registrant previously in support of the registration of the pesticide that are inadequate to meet such regulations; and
(iii) data identified under clause (i) that have not been submitted to the Administrator; and
(B) either—
(i) a commitment to replace the data identified under subparagraph (A)(ii) and submit the data identified under subparagraph (A)(iii) within the applicable time period prescribed by paragraph (4)(B); or
(ii) an offer to share in the cost to be incurred by a person who has made a commitment under clause (i) to replace or submit the data and an offer to submit to arbitration as described by section 136a(c)(2)(B) of this title with regard to such cost sharing.
For purposes of a submission by a registrant under subparagraph (A)(ii), data are inadequate if the data are derived from a study with respect to which the registrant is unable to make the certification prescribed by subsection (e)(1)(G) that the registrant possesses or has access to the raw data used in or generated by such study. For purposes of a submission by a registrant under such subparagraph, data shall be considered to be inadequate if the data are derived from a study submitted before January 1, 1970, unless it is demonstrated to the satisfaction of the Administrator that such data should be considered to support the registration of the pesticide that is to be reregistered.
(4) Time periods
(A) A submission under paragraph (2) or (3) shall be made—
(i) in the case of a pesticide containing an active ingredient listed under subsection (c)(2)(B), not later than 3 months after the date of publication of the listing of such active ingredient;
(ii) in the case of a pesticide containing an active ingredient listed under subsection (c)(2)(C), not later than 3 months after the date of publication of the listing of such active ingredient; and
(iii) in the case of a pesticide containing an active ingredient listed under subsection (c)(2)(D), not later than 3 months after the date of publication of the listing of such active ingredient.
On application, the Administrator may extend a time period prescribed by this subparagraph if the Administrator determines that factors beyond the control of the registrant prevent the registrant from complying with such period.
(B) A registrant shall submit data in accordance with a commitment entered into under paragraph (3)(B) within a reasonable period of time, as determined by the Administrator, but not more than 48 months after the date the registrant submitted the commitment. The Administrator, on application of a registrant, may extend the period prescribed by the preceding sentence by no more than 2 years if extraordinary circumstances beyond the control of the registrant prevent the registrant from submitting data within such prescribed period. Upon application of a registrant, the Administrator shall, in the case of a minor use, extend the deadline for the production of residue chemistry data under this subparagraph for data required solely to support that minor use until the final deadline for submission of data under this section for the other uses of the pesticide established as of August 3, 1996, if—
(i) the data to support other uses of the pesticide on a food are being provided;
(ii) the registrant, in submitting a request for such an extension provides a schedule, including interim dates to measure progress, to assure that the data production will be completed before the expiration of the extension period;
(iii) the Administrator has determined that such extension will not significantly delay the Administrator’s schedule for issuing a reregistration eligibility determination required under this section; and
(iv) the Administrator has determined that based on existing data, such extension would not significantly increase the risk of any unreasonable adverse effect on the environment. If the Administrator grants an extension under this subparagraph, the Administrator shall monitor the development of the data and shall ensure that the registrant is meeting the schedule for the production of the data. If the Administrator determines that the registrant is not meeting or has not met the schedule for the production of such data, the Administrator may proceed in accordance with clause (iv) of section 136a(c)(2)(B) of this title or other provisions of this section, as appropriate, regarding the continued registration of the affected products with the minor use and shall inform the public of such action. Notwithstanding the provisions of this subparagraph, the Administrator may take action to modify or revoke the extension under this subparagraph if the Administrator determines that the extension for the minor use may cause an unreasonable adverse effect on the environment. In such circumstance, the Administrator shall provide written notice to the registrant revoking the extension of time for submission of data. Such data shall instead be due in accordance with the date then established by the Administrator for submission of the data.
(5) Cancellation and removal
(A) If the registrant of a pesticide does not submit a notice under paragraph (2) or (3) within the time prescribed by paragraph (4)(A), the Administrator shall issue a notice of intent to cancel the registration of such registrant for such pesticide and shall publish the notice in the Federal Register and allow 60 days for the submission of comments on the notice. On expiration of such 60 days, the Administrator, by order and without a hearing, may cancel the registration or take such other action, including extension of applicable time periods, as may be necessary to enable reregistration of such pesticide by another person.
(B)
(i) If—(I) no registrant of a pesticide containing an active ingredient listed under subsection (c)(2) notifies the Administrator under paragraph (2) that the registrant intends to seek reregistration of any pesticide containing that active ingredient;(II) no such registrant complies with paragraph (3)(A); or(III) no such registrant makes a commitment under paragraph (3)(B) to replace or submit all data described in clauses (ii) and (iii) of paragraph (3)(A);
the Administrator shall publish in the Federal Register a notice of intent to remove the active ingredient from the list established under subsection (c)(2) and a notice of intent to cancel the registrations of all pesticides containing such active ingredient and shall provide 60 days for comment on such notice.
(ii) After the 60-day period has expired, the Administrator, by order, may cancel any such registration without hearing, except that the Administrator shall not cancel a registration under this subparagraph if—(I) during the comment period a person acquires the rights of the registrant in that registration;(II) during the comment period that person furnishes a notice of intent to reregister the pesticide in accordance with paragraph (2); and(III) not later than 120 days after the publication of the notice under this subparagraph, that person has complied with paragraph (3) and the fee prescribed by this section has been paid.
(6) Suspensions and penalties
(e) Phase three
(1) Information about studiesEach registrant of a pesticide that contains an active ingredient listed under subparagraph (B), (C), or (D) of subsection (c)(2) who has submitted a notice under subsection (d)(2) of an intent to seek the reregistration of such pesticide shall submit, in accordance with the guidelines issued under paragraph (4), to the Administrator—
(A) a summary of each study concerning the active ingredient previously submitted by the registrant in support of the registration of a pesticide containing such active ingredient and considered by the registrant to be adequate to meet the requirements of section 136a of this title and the regulations issued under such section;
(B) a summary of each study concerning the active ingredient previously submitted by the registrant in support of the registration of a pesticide containing such active ingredient that may not comply with the requirements of section 136a of this title and the regulations issued under such section but which the registrant asserts should be deemed to comply with such requirements and regulations;
(C) a reformat of the data from each study summarized under subparagraph (A) or (B) by the registrant concerning chronic dosing, oncogenicity, reproductive effects, mutagenicity, neurotoxicity, teratogenicity, or residue chemistry of the active ingredient that were submitted to the Administrator before January 1, 1982;
(D) where data described in subparagraph (C) are not required for the active ingredient by regulations issued under section 136a of this title, a reformat of acute and subchronic dosing data submitted by the registrant to the Administrator before January 1, 1982, that the registrant considers to be adequate to meet the requirements of section 136a of this title and the regulations issued under such section;
(E) an identification of data that are required to be submitted to the Administrator under section 136d(a)(2) of this title, indicating an adverse effect of the pesticide;
(F) an identification of any other information available that in the view of the registrant supports the registration;
(G) a certification that the registrant or the Administrator possesses or has access to the raw data used in or generated by the studies that the registrant summarized under subparagraph (A) or (B);
(H) either—
(i) a commitment to submit data to fill each outstanding data requirement identified by the registrant; or
(ii) an offer to share in the cost of developing such data to be incurred by a person who has made a commitment under clause (i) to submit such data, and an offer to submit to arbitration as described by section 136a(c)(2)(B) of this title with regard to such cost sharing; and
(I) evidence of compliance with section 136a(c)(1)(D)(ii) 1
1 See References in Text note below.
of this title and regulations issued thereunder with regard to previously submitted data as if the registrant were now seeking the original registration of the pesticide.
A registrant who submits a certification under subparagraph (G) that is false shall be considered to have violated this subchapter and shall be subject to the penalties prescribed by section 136l of this title.
(2) Time periods
(A) The information required by paragraph (1) shall be submitted to the Administrator—
(i) in the case of a pesticide containing an active ingredient listed under subsection (c)(2)(B), not later than 12 months after the date of publication of the listing of such active ingredient;
(ii) in the case of a pesticide containing an active ingredient listed under subsection (c)(2)(C), not later than 12 months after the date of publication of the listing of such active ingredient; and
(iii) in the case of a pesticide containing an active ingredient listed under subsection (c)(2)(D), not later than 12 months after the date of publication of the listing of such active ingredient.
(B) A registrant shall submit data in accordance with a commitment entered into under paragraph (1)(H) within a reasonable period of time, as determined by the Administrator, but not more than 48 months after the date the registrant submitted the commitment under such paragraph. The Administrator, on application of a registrant, may extend the period prescribed by the preceding sentence by no more than 2 years if extraordinary circumstances beyond the control of the registrant prevent the registrant from submitting data within such prescribed period. Upon application of a registrant, the Administrator shall, in the case of a minor use, extend the deadline for the production of residue chemistry data under this subparagraph for data required solely to support that minor use until the final deadline for submission of data under this section for the other uses of the pesticide established as of
(i) the data to support other uses of the pesticide on a food are being provided;
(ii) the registrant, in submitting a request for such an extension provides a schedule, including interim dates to measure progress, to assure that the data production will be completed before the expiration of the extension period;
(iii) the Administrator has determined that such extension will not significantly delay the Administrator’s schedule for issuing a reregistration eligibility determination required under this section; and
(iv) the Administrator has determined that based on existing data, such extension would not significantly increase the risk of any unreasonable adverse effect on the environment. If the Administrator grants an extension under this subparagraph, the Administrator shall monitor the development of the data and shall ensure that the registrant is meeting the schedule for the production of the data. If the Administrator determines that the registrant is not meeting or has not met the schedule for the production of such data, the Administrator may proceed in accordance with clause (iv) of section 136a(c)(2)(B) of this title or other provisions of this section, as appropriate, regarding the continued registration of the affected products with the minor use and shall inform the public of such action. Notwithstanding the provisions of this subparagraph, the Administrator may take action to modify or revoke the extension under this subparagraph if the Administrator determines that the extension for the minor use may cause an unreasonable adverse effect on the environment. In such circumstance, the Administrator shall provide written notice to the registrant revoking the extension of time for submission of data. Such data shall instead be due in accordance with the date then established by the Administrator for submission of the data.
(3) Cancellation
(A) If the registrant of a pesticide fails to submit the information required by paragraph (1) within the time prescribed by paragraph (2), the Administrator, by order and without hearing, shall cancel the registration of such pesticide. If the registrant does not commit to support a specific minor use of the pesticide, but is supporting and providing data in a timely and adequate fashion to support uses of the pesticide on a food, or if all uses of the pesticide are nonfood uses and the registrant does not commit to support a specific minor use of the pesticide but is supporting and providing data in a timely and adequate fashion to support other nonfood uses of the pesticide, the Administrator, at the written request of the registrant, shall not take any action pursuant to this subparagraph in regard to such unsupported minor use until the final deadline established as of August 3, 1996, for the submission of data under this section for the supported uses identified pursuant to this subparagraph unless the Administrator determines that the absence of the data is significant enough to cause human health or environmental concerns. On the basis of such determination, the Administrator may refuse the request for extension by the registrant. Upon receipt of the request from the registrant, the Administrator shall publish in the Federal Register a notice of the receipt of the request and the effective date upon which the uses not being supported will be voluntarily deleted from the registration pursuant to section 136d(f)(1) of this title. If the Administrator grants an extension under this subparagraph, the Administrator shall monitor the development of the data for the uses being supported and shall ensure that the registrant is meeting the schedule for the production of such data. If the Administrator determines that the registrant is not meeting or has not met the schedule for the production of such data, the Administrator may proceed in accordance with section 136a(c)(2)(B)(iv) of this title regarding the continued registration of the affected products with the minor and other uses and shall inform the public of such action in accordance with section 136d(f)(2) of this title. Notwithstanding this subparagraph, the Administrator may deny, modify, or revoke the temporary extension under this subparagraph if the Administrator determines that the continuation of the minor use may cause an unreasonable adverse effect on the environment. In the event of modification or revocation, the Administrator shall provide, in writing, to the registrant a notice revoking the temporary extension and establish a new effective date by which the minor use shall be deleted from the registration.
(B)
(i) If the registrant of a pesticide submits the information required by paragraph (1) within the time prescribed by paragraph (2) and such information does not conform to the guidelines for submissions established by the Administrator, the Administrator shall determine whether the registrant made a good faith attempt to conform its submission to such guidelines.
(ii) If the Administrator determines that the registrant made a good faith attempt to conform its submission to such guidelines, the Administrator shall provide the registrant a reasonable period of time to make any necessary changes or corrections.
(iii)(I) If the Administrator determines that the registrant did not make a good faith attempt to conform its submission to such guidelines, the Administrator may issue a notice of intent to cancel the registration. Such a notice shall be sent to the registrant by certified mail.(II) The registration shall be canceled without a hearing or further notice at the end of 30 days after receipt by the registrant of the notice unless during that time a request for a hearing is made by the registrant.(III) If a hearing is requested, a hearing shall be conducted under section 136d(d) of this title, except that the only matter for resolution at the hearing shall be whether the registrant made a good faith attempt to conform its submission to such guidelines. The hearing shall be held and a determination made within 75 days after receipt of a request for hearing.
(4) Guidelines
(A) Not later than 1 year after the effective date of this section, the Administrator, by order, shall issue guidelines to be followed by registrants in—
(i) summarizing studies;
(ii) reformatting studies;
(iii) identifying adverse information; and
(iv) identifying studies that have been submitted previously that may not meet the requirements of section 136a of this title or regulations issued under such section,
under paragraph (1).
(B) Guidelines issued under subparagraph (A) shall not be subject to judicial review.
(5) Monitoring
(f) Phase four
(1) Independent review and identification of outstanding data requirements
(A) The Administrator shall review the submissions of all registrants of pesticides containing a particular active ingredient under subsections (d)(3) and (e)(1) to determine if such submissions identified all the data that are missing or inadequate for such active ingredient. To assist the review of the Administrator under this subparagraph, the Administrator may require a registrant seeking reregistration to submit complete copies of studies summarized under subsection (e)(1).
(B) The Administrator shall independently identify and publish in the Federal Register the outstanding data requirements for each active ingredient that is listed under subparagraph (B), (C), or (D) of subsection (c)(2) and that is contained in a pesticide to be reregistered under this section. The Administrator, at the same time, shall issue a notice under section 136a(c)(2)(B) of this title for the submission of the additional data that are required to meet such requirements.
(2) Time periods
(A) The Administrator shall take the action required by paragraph (1)—
(i) in the case of a pesticide containing an active ingredient listed under subsection (c)(2)(B), not later than 18 months after the date of the listing of such active ingredient;
(ii) in the case of a pesticide containing an active ingredient listed under subsection (c)(2)(C), not later than 24 months after the date of the listing of such active ingredient; and
(iii) in the case of a pesticide containing an active ingredient listed under subsection (c)(2)(D), not later than 33 months after the date of the listing of such active ingredient.
(B) If the Administrator issues a notice to a registrant under paragraph (1)(B) for the submission of additional data, the registrant shall submit such data within a reasonable period of time, as determined by the Administrator, but not to exceed 48 months after the issuance of such notice. The Administrator, on application of a registrant, may extend the period prescribed by the preceding sentence by no more than 2 years if extraordinary circumstances beyond the control of the registrant prevent the registrant from submitting data within such prescribed period. Upon application of a registrant, the Administrator shall, in the case of a minor use, extend the deadline for the production of residue chemistry data under this subparagraph for data required solely to support that minor use until the final deadline for submission of data under this section for the other uses of the pesticide established as of August 3, 1996, if—
(i) the data to support other uses of the pesticide on a food are being provided;
(ii) the registrant, in submitting a request for such an extension provides a schedule, including interim dates to measure progress, to assure that the data production will be completed before the expiration of the extension period;
(iii) the Administrator has determined that such extension will not significantly delay the Administrator’s schedule for issuing a reregistration eligibility determination required under this section; and
(iv) the Administrator has determined that based on existing data, such extension would not significantly increase the risk of any unreasonable adverse effect on the environment. If the Administrator grants an extension under this subparagraph, the Administrator shall monitor the development of the data and shall ensure that the registrant is meeting the schedule for the production of the data. If the Administrator determines that the registrant is not meeting or has not met the schedule for the production of such data, the Administrator may proceed in accordance with clause (iv) of section 136a(c)(2)(B) of this title or other provisions of this section, as appropriate, regarding the continued registration of the affected products with the minor use and shall inform the public of such action. Notwithstanding the provisions of this subparagraph, the Administrator may take action to modify or revoke the extension under this subparagraph if the Administrator determines that the extension for the minor use may cause an unreasonable adverse effect on the environment. In such circumstance, the Administrator shall provide written notice to the registrant revoking the extension of time for submission of data. Such data shall instead be due in accordance with the date then established by the Administrator for submission of the data.
(3) Suspensions and penalties
(g) Phase five
(1) Data review
(2) Reregistration and other actions
(A)In general.—The Administrator shall make a determination as to eligibility for reregistration—
(i) for all active ingredients subject to reregistration under this section for which tolerances or exemptions from tolerances are required under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), not later than the last date for tolerance reassessment established under section 408(q)(1)(C) of that Act (21 U.S.C. 346a(q)(1)(C)); and
(ii) for all other active ingredients subject to reregistration under this section, not later than October 3, 2008.
(B)Product-specific data.—
(i)In general.—Before reregistering a pesticide, the Administrator shall obtain any needed product-specific data regarding the pesticide by use of section 136a(c)(2)(B) of this title and shall review such data within 90 days after its submission.
(ii)Timing.—(I)In general.—Subject to subclause (II), the Administrator shall require that data under this subparagraph be submitted to the Administrator not later than 8 months after a determination of eligibility under subparagraph (A) has been made for each active ingredient of the pesticide, unless the Administrator determines that a longer period is required for the generation of the data.(II)Extraordinary circumstances.—In the case of extraordinary circumstances, the Administrator may provide such a longer period, of not more than 2 additional years, for submission of data to the Administrator under this subparagraph.
(C) After conducting the review required by paragraph (1) for each active ingredient of a pesticide and the review required by subparagraph (B) of this paragraph, the Administrator shall determine whether to reregister a pesticide by determining whether such pesticide meets the requirements of section 136a(c)(5) of this title. If the Administrator determines that a pesticide is eligible to be reregistered, the Administrator shall reregister such pesticide within 6 months after the submission of the data concerning such pesticide under subparagraph (B).
(D)Determination to not reregister.—
(i)In general.—If after conducting a review under paragraph (1) or subparagraph (B) of this paragraph the Administrator determines that a pesticide should not be reregistered, the Administrator shall take appropriate regulatory action.
(ii)Timing for regulatory action.—Regulatory action under clause (i) shall be completed as expeditiously as possible.
(E) As soon as the Administrator has sufficient information with respect to the dietary risk of a particular active ingredient, but in any event no later than the time the Administrator makes a determination under subparagraph (C) or (D) with respect to pesticides containing a particular active ingredient, the Administrator shall—
(i) reassess each associated tolerance and exemption from the requirement for a tolerance issued under section 408 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a);
(ii) determine whether such tolerance or exemption meets the requirements of that Act [21 U.S.C. 301 et seq.];
(iii) determine whether additional tolerances or exemptions should be issued;
(iv) publish in the Federal Register a notice setting forth the determinations made under this subparagraph; and
(v) commence promptly such proceedings under this subchapter and section 408 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 346a] as are warranted by such determinations.
(h) Compensation of data submitter
(i) Fees
(1) Maintenance fee
(A)In general.—Subject to other provisions of this paragraph, each registrant of a pesticide shall pay an annual fee by January 15 of each year for each registration, except that no fee shall be charged for more than 200 registrations held by any registrant.
(B) In the case of a pesticide that is registered for a minor agricultural use, the Administrator may reduce or waive the payment of the fee imposed under this paragraph if the Administrator determines that the fee would significantly reduce the availability of the pesticide for the use.
(C)Total amount of fees.—The amount of each fee prescribed under subparagraph (A) shall be adjusted by the Administrator to a level that will result in the collection under this paragraph of, to the extent practicable, an average amount of $31,000,000 for each of fiscal years 2019 through 2022, and $42,000,000 for each of fiscal years 2023 through 2027.
(D)Maximum amount of fees for registrants.—The maximum annual fee payable under this paragraph by—
(i) a registrant holding not more than 50 pesticide registrations shall be $129,400 for each of fiscal years 2019 through 2022, and $172,000 for each of fiscal years 2023 through 2027; and
(ii) a registrant holding over 50 registrations shall be $207,000 for each of fiscal years 2019 through 2022, and $277,200 for each of fiscal years 2023 through 2027.
(E)Maximum amount of fees for small businesses.—
(i)In general.—For a small business, the maximum annual fee payable under this paragraph by—(I) a registrant holding not more than 50 pesticide registrations shall be $79,100 for each of fiscal years 2019 through 2022, and $105,000 for each of fiscal years 2023 through 2027; and(II) a registrant holding over 50 pesticide registrations shall be $136,800 for each of fiscal years 2019 through 2022, and $184,800 for each of fiscal years 2023 through 2027.
(ii)Definition of small business.—(I)In general.—In clause (i), the term “small business” means a corporation, partnership, or unincorporated business that—(aa) has 500 or fewer employees; and(bb) during the 3-year period prior to the most recent maintenance fee billing cycle, had an average annual global gross revenue from pesticides that did not exceed $60,000,000.(II)Affiliates.—(aa)In general.—In the case of a business entity with 1 or more affiliates, the gross revenue limit under subclause (I)(bb) shall apply to the gross revenue for the entity and all of the affiliates of the entity, including parents and subsidiaries, if applicable.(bb)Affiliated persons.—For the purpose of item (aa), persons are affiliates of each other if, directly or indirectly, either person controls or has the power to control the other person, or a third person controls or has the power to control both persons.(cc)Indicia of control.—For the purpose of item (aa), indicia of control include interlocking management or ownership, identity of interests among family members, shared facilities and equipment, and common use of employees.
(F)Fee reduction for certain small businesses.—
(i)Definition.—In this subparagraph, the term “qualified small business entity” means a corporation, partnership, or unincorporated business that—(I) has 500 or fewer employees;(II) during the 3-year period prior to the most recent maintenance fee billing cycle, had an average annual global gross revenue from all sources that did not exceed $10,000,000; and(III) holds not more than 5 pesticide registrations under this paragraph.
(ii)Waiver.—Except as provided in clause (iii), the Administrator shall waive 25 percent of the fee under this paragraph applicable to the first registration of any qualified small business entity under this paragraph.
(iii)Limitation.—The Administrator shall not grant a waiver under clause (ii) to a qualified small business entity if the Administrator determines that the entity has been formed or manipulated primarily for the purpose of qualifying for the waiver.
(G)Farm worker training and education grants.—
(i)Set-aside.—In addition to amounts otherwise available, for fiscal years 2023 through 2027, the Administrator shall use not more than $7,500,000 of the amounts collected under this paragraph to provide grants to organizations described in clause (ii) for purposes of facilitating—(I) training of farm workers;(II) education of farm workers with respect to—(aa) rights of farm workers relating to pesticide safety; and(bb) the worker protection standard under part 170 of title 40, Code of Federal Regulations (or successor regulations);(III) the development of new informational materials;(IV) the development of training modules; and(V) the development of innovative methods of delivery of such informational materials and training modules.
(ii)Eligibility.—To be eligible to receive a grant under this subparagraph, an organization shall have demonstrated experience in—(I) providing training and education services for farm workers or handlers of pesticides; or(II) developing informational materials for farm workers or handlers of pesticides.
(iii)Community-based organizations.—(I)Community-based non-profit farm worker organization grants.—The Administrator shall use funds available under clause (i) to provide grants to community-based non-profit farm worker organizations.(II)Application of funds.—The Administrator shall apply the unspent balance of funds available (up to $1,800,000) under clause (i) in fiscal years 2025 through 2027 to carry out subclause (I).
(iv)Interim funding.—In addition to amounts otherwise available, the Administrator may use not more than $1,200,000 in fiscal years 2023 and 2024 to fund existing cooperative agreements that were authorized under section 136w–8(c)(3)(B) of this title, as such section was in effect as of March 8, 2019.
(v)Partnerships.—Organizations described in clause (ii) may apply for a grant under this subparagraph as a partnership with another organization, provided such organizations, at the time of application, have entered into an agreement designating—(I) a member of the partnership that will enter into the assistance agreement with the Environmental Protection Agency for the purposes of accountability for the proper expenditure of Federal funds;(II) performance of the assistance agreement;(III) liability for claims for recovery of unallowable costs incurred under the agreement; and(IV) specifying roles in performing the proposed scope of work for the assistance agreement.
(H)Health care provider training.—
(i)Set-aside.—In addition to other amounts available, for the period of fiscal years 2023 through 2027, the Administrator shall use not more than $2,500,000 of the amounts collected under this paragraph to provide grants to nonprofit organizations described in clause (ii) for purposes of facilitating—(I) technical assistance and training of health care providers relating to the recognition, treatment, and management of pesticide-related injuries and illnesses;(II) the development of informational materials for technical assistance and training described in subclause (I); and(III) the development of outreach and delivery methods relating to the recognition, treatment, and management of pesticide-related illnesses.
(ii)Eligibility.—To be eligible to receive a grant under this subparagraph, a nonprofit organization shall have demonstrated experience in providing technical assistance and training to health care providers who serve farm worker populations.
(iii)Partnerships.—Organizations described in clause (ii) may apply for a grant under this subparagraph as a partnership with another organization, provided such organizations, at the time of application, have entered into an agreement designating—(I) a member of the partnership that will enter into the assistance agreement with the Environmental Protection Agency for the purposes of accountability for the proper expenditure of Federal funds;(II) performance of the assistance agreement;(III) liability for claims for recovery of unallowable costs incurred under the agreement; and(IV) roles in performing the proposed scope of work for the assistance agreement.
(I)Partnership grants.—In addition to funds otherwise available, for each of fiscal years 2023 through 2027, the Administrator shall use not more than $500,000 of the amounts collected under this paragraph for partnership grants.
(J)Pesticide safety education program.—In addition to amounts otherwise available, for each of fiscal years 2023 through 2027, the Administrator shall use not more than $500,000 of the amounts collected under this paragraph to carry out the pesticide safety education program.
(K)Technical assistance to grantees.—
(i)Set-aside.—In addition to other amounts available, for fiscal years 2023 through 2027, the Administrator shall use not more than $1,750,000 of the amounts collected under this paragraph to provide grants to nonprofit organizations, subject to such conditions as the Administrator establishes to prevent conflicts of interest, to provide easily accessible technical assistance to grantees receiving, and potential grantees applying for, grants under subparagraphs (G) and (H).
(ii)Considerations.—In evaluating requests for grants under this subparagraph, the Administrator shall consider, at a minimum, the extent to which—(I) the organization applying for the grant has experience providing technical assistance to farm worker or clinician-training organizations; and(II) the proposed project would make specific technical assistance available to organizations seeking information and assistance concerning—(aa) the grant application process;(bb) the drafting of grant applications; and(cc) compliance with grant management and reporting requirements.
(iii)No suitable organization.—If no suitable organization requests a grant under this subparagraph, the Administrator shall provide technical assistance described in clause (i) using the amounts made available by that clause.
(iv)Stakeholder input.—In formulating requests for proposals for grants under subparagraphs (G) and (H) for a fiscal year, the Administrator shall solicit and consider, in an open and transparent manner that does not provide a competitive advantage to any person or persons, input from persons who conduct farm worker education and training, or technical assistance and training of clinicians, regarding the request for proposals.
(L) The Administrator shall exempt any public health pesticide from the payment of the fee prescribed under this paragraph if, in consultation with the Secretary of Health and Human Services, the Administrator determines, based on information supplied by the registrant, that the economic return to the registrant from sales of the pesticide does not support the registration or reregistration of the pesticide.
(M) If any fee prescribed by this paragraph with respect to the registration of a pesticide is not paid by a registrant by the time prescribed, the Administrator, by order and without hearing, may cancel the registration.
(N) The authority provided under this paragraph shall terminate on September 30, 2027.
(2) Other fees
(j) Exemption of certain registrants
(k) Reregistration and expedited processing fund
(1) Establishment
(2) Source and use
(A) All moneys derived from fees collected by the Administrator under subsection (i) shall be deposited in the Reregistration and Expedited Processing Fund and shall be available to the Administrator, without fiscal year limitation, including, to the maximum extent practicable, during periods in which Environmental Protection Agency employees are on shutdown or emergency furlough as a result of a lapse in appropriations, specifically to offset the costs of reregistration and expedited processing of the applications specified in paragraph (3), to offset the costs of registration review under section 136a(g) of this title, including the costs associated with any review under the Endangered Species Act of 1973 (16 U.S.C. 1531 et seq.) required as part of the registration review, to offset the costs associated with tracking and implementing registration review decisions, including registration review decisions designed to reduce risk, for the purposes specified in paragraphs (4) and (5), and to enhance the information systems capabilities to improve the tracking of pesticide registration decisions. The Administrator shall, prior to expending any such moneys derived from fees—
(i) effective October 1, 1997, adopt specific and cost accounting rules and procedures as approved by the Government Accountability Office and the Inspector General of the Environmental Protection Agency to ensure that moneys derived from fees are allocated solely for the purposes specified in the first sentence of this subparagraph;
(ii) prohibit the use of such moneys derived from fees to pay for any costs other than those necessary to achieve the purposes specified in the first sentence of this subparagraph; and
(iii) ensure that personnel and facility costs associated with the functions to be carried out under this paragraph do not exceed agency averages for comparable personnel and facility costs.
(B) The Administrator shall also—
(i) complete the review of unreviewed reregistration studies required to support the reregistration eligibility decisions scheduled for completion in accordance with subsection (l)(2); and
(ii) contract for such outside assistance as may be necessary for review of required studies, using a generally accepted competitive process for the selection of vendors of such assistance.
(3) Review of registrant submissions not covered by section 136w–8(b)(3)(B) of this title
(A) Definition of submission not covered by
(B) Set-aside
(i) In general
(ii) ActivitiesIn addition to amounts otherwise available, the Administrator shall use amounts made available under clause (i) to obtain sufficient personnel and resources to process submissions not covered by section 136w–8(b)(3)(B) of this title to meet the applicable deadlines described in—(I) the notice of the Administrator entitled “Pesticide Registration Notice (PR) 98–10: Notifications, Non-Notifications and Minor Formulation Amendments” and dated October 22, 1998 (and any successor amendments to such notice); and(II) subsections (c)(3)(B) and (h) of section 136a of this title.
(4) Development of public health performance standards for antimicrobial pesticide devices
(A) Set-aside
(B) Antimicrobial pesticide devices
(5) Good laboratory practices inspections
(A) Set-aside
(B) Activities
(6) Agency training and staff
(A) Set-aside
(B) ActivitiesThe Administrator shall use amounts made available under subparagraph (A) to carry out the following activities:
(i) Training for agency employeesThe Administrator shall administer training and education programs for employees of the Environmental Protection Agency, relating to the regulatory responsibilities and policies established by this subchapter, including programs—(I) for improving the scientific, technical, and administrative skills of officers and employees authorized to administer programs under this subchapter;(II) to align competencies identified by the Administrator for mission accomplishment;(III) for addressing best practices for operational performance and improvement;(IV) for improving administrative processes and procedures and addressing efficiency issues;(V) to promote consistent regulatory decision-making; and(VI) for educating registrants and regulated stakeholders on regulatory procedures.
(ii) Agreements with institutions of higher educationNot later than 1 year, to the maximum extent practicable, after December 29, 2022, the Administrator shall establish a competitive grant program to develop training curricula and programs in accordance with clause (i) through financial assistance agreements with 1 or more of the following institutions of higher education:(I) Non-land-grant colleges of agriculture (as defined in section 3103 of this title).(II) Land-grant colleges and universities (as defined in section 3103 of this title).(III) 1994 Institutions (as defined in section 532 of the Equity in Educational Land-Grant Status Act of 1994 (7 U.S.C. 301 note; Public Law 103–382)).
(7) Vector expedited review vouchers
(A) Set-aside
(B) Vector Expedited Review Voucher program
(i) DefinitionsIn this subparagraph:(I) Program(II) VoucherThe term “voucher” means a voucher—(aa) issued under the program by the Administrator to a pesticide registration applicant that entitles the holder to an expedited review described under clause (vi) of a single different pesticide registration action; and(bb) the entitlement to which may be transferred (including by sale) by the holder of the voucher, without limitation on the number of times the voucher may be transferred, before the voucher is redeemed.
(ii) Establishment
(iii) Purpose
(iv) Issuance of vouchers(I) In generalFor each of fiscal years 2023 through 2027, the Administrator shall issue a voucher to a pesticide registration applicant for a new active ingredient if the applicant submits and has successfully registered a mosquito-control product that—(aa) demonstrates a proven efficacy against pyrethroid or other insecticide-resistant mosquitoes;(bb) prevents, mitigates, destroys, or repels pyrethroid or other insecticide-resistant mosquitoes, with a novel or unique mechanism or mode of action, different from other insecticides already registered by the Administrator for mosquito control;(cc) targets mosquitoes capable of spreading such diseases as Malaria, Dengue, Zika, Chikungunya, St. Louis encephalitis, Eastern encephalitis, Western encephalitis, West Nile encephalitis, Cache Valley encephalitis, LaCrosse encephalitis, and Yellow Fever;(dd) the registrant has submitted a global access plan that will be made publicly available for the active ingredient and that includes—(AA) manufacturing locations, including any licensed third-party manufacturers;(BB) distribution and procurement processes for malaria vector control programs in selected countries; and(CC) the prices for common quantities of the product;(ee) meets the appropriate guidelines as being effective in the primary vector control intervention areas, including insecticide-treated nets and indoor residual spray;(ff) is made accessible for use in—(AA) the United States, including territories or possessions of the United States; and(BB) countries where mosquito-borne diseases, such as malaria, are prevalent;(gg) meets registration requirements for human health and environmental effects, labeling, and presents no unreasonable adverse effects to the environment;(hh) broadens the adoption of integrated pest management strategies, such as insecticide resistance management, or makes those strategies more effective;(ii) is not contained in any pesticide product registered by the Administrator as of December 29, 2022; or(jj) does not contain as attested to by the registrant, an active ingredient approved in the 2-year period preceding the date of registration by any global stringent regulatory authority for the same uses, vectors, and applications.(II) Mosquito vector priority(III) Exception(IV) Eligibility criteria modifications(aa) In generalBeginning in fiscal year 2028, the Administrator shall review the program and recommend—(AA) modifications to the requirements described in subclause (I); and(BB) additional vectors to be included in the program, prioritizing vectors that pose the most significant population health risks.(bb) Public involvement
(v) Redemption of vouchersTo redeem a voucher, the holder shall—(I) notify the Administrator of the intent of the holder to submit a pesticide application with a voucher for expedited review not less than 90 days before the submission of the application; and(II) pay the applicable registration service fee under section 136w–8(b) of this title.
(vi) Expedited reviewOn redemption of a voucher, in furtherance of the purpose described in clause (iii), the Administrator shall expedite decision review times as follows:(I) 6 months less than the decision review time for Category R010, New Active Ingredient, Food use.(II) 6 months less than the decision review time for Category R020, New Active Ingredient, Food use; reduced risk.(III) 6 months less than the decision review time for Category R060, New Active Ingredient, Non-food use; outdoor.(IV) 6 months less than the decision review time for Category R110, New Active Ingredient, Non-food use; indoor.(V) 4 months less than the decision review time for Category R070, New Active Ingredient, Non-food use; outdoor; reduced risk.(VI) 2 months less than the decision review time for Category R120, New Active Ingredient, Non-food use; indoor; reduced risk.
(vii) ReportsNot later than September 30, 2025, and not later than September 30 of each year thereafter, the Administrator shall issue a report on the program, including—(I) the number of submissions seeking a voucher;(II) the total time in review for each such submission;(III) the number of such vouchers awarded;(IV) the number of such vouchers redeemed; and(V) with respect to each such redeemed voucher—(aa) the decision review time for the pesticide application for which the voucher was redeemed; and(bb) the average standard decision review time for the applicable pesticide category.
(C) Unused amounts
(8) Pesticide surveillance programIn addition to amounts otherwise available, for each of fiscal years 2023 through 2027, the Administrator shall use not more than $500,000 of the amounts made available to the Administrator in the Reregistration and Expedited Processing Fund to support the interagency agreement with the National Institute for Occupational Safety and Health to support the Sentinel Event Notification System for Occupational Risk pesticides program—
(A) with a goal of increasing the number of participating States, prioritizing expansion in States with the highest numbers of agricultural workers; and
(B) to improve reporting by participating States.
(9) Unused fundsMoney in the fund not currently needed to carry out this section shall be—
(A) maintained on hand or on deposit;
(B) invested in obligations of the United States or guaranteed thereby; or
(C) invested in obligations, participations, or other instruments that are lawful investments for fiduciary, trust, or public funds.
(10) Accounting and performance
(l) Performance measures and goalsThe Administrator shall establish and publish annually in the Federal Register performance measures and goals. Such measures and goals shall include—
(1) the number of products reregistered, canceled, or amended, the status of reregistration, the number and type of data requests under section 136a(c)(2)(B) of this title issued to support product reregistration by active ingredient, the progress in reducing the number of unreviewed, required reregistration studies, the aggregate status of tolerances reassessed, and the number of applications for registration submitted under subsection (k)(3) that were approved or disapproved;
(2) the future schedule for reregistrations, including the projection for such schedules that will be issued under subsection (g)(2)(A) and (B) in the current fiscal year and the succeeding fiscal year; and
(3) the projected year of completion of the reregistrations under this section.
(m) Judicial review
(n) Authorization of funds to develop public health data
(1) “Secretary” defined
(2) Consultation
(3) Benefits to support family
(4) Additional time
(5) Arrangements
(6) Support
(7) Authorization of appropriations
(June 25, 1947, ch. 125, § 4, formerly § 3A, as added and renumbered § 4, Pub. L. 100–532, title I, § 102(a), title VIII, § 801(q)(2)(A), Oct. 25, 1988, 102 Stat. 2655, 2683; amended Pub. L. 101–624, title XIV, § 1493, Nov. 28, 1990, 104 Stat. 3628; Pub. L. 102–237, title X, § 1006(a)(4), (e), (f), Dec. 13, 1991, 105 Stat. 1895–1897; Pub. L. 104–170, title I, § 103, title II, §§ 210(c)(2), (f)(1), 232, 237, title V, § 501, Aug. 3, 1996, 110 Stat. 1490, 1496, 1498, 1508, 1509, 1536; Pub. L. 107–73, title III, [(1)–(4)], Nov. 26, 2001, 115 Stat. 686; Pub. L. 108–7, div. K, title III, [(1)–(4)], Feb. 20, 2003, 117 Stat. 513; Pub. L. 108–199, div. G, title V, § 501(c), (d)(1), (e), Jan. 23, 2004, 118 Stat. 419, 422; Pub. L. 108–271, § 8(b), July 7, 2004, 118 Stat. 814; Pub. L. 110–94, § 4(a)–(d)(1), (e), Oct. 9, 2007, 121 Stat. 1001, 1002; Pub. L. 112–177, § 2(a)(1), (2)(A), (4), Sept. 28, 2012, 126 Stat. 1327, 1329; Pub. L. 116–8, §§ 2(a), (b), 3, Mar. 8, 2019, 133 Stat. 484, 485; Pub. L. 117–328, div. HH, title VI, §§ 703(a), 704, Dec. 29, 2022, 136 Stat. 5999, 6002.)

CITE AS: 7 USC 136a-1

§ 136b. Transferred

CITE AS: 7 USC 136b

§ 136c. Experimental use permits
(a) Issuance
(b) Temporary tolerance level
(c) Use under permit
(d) Studies
(e) Revocation
(f) State issuance of permits
(g) Exemption for agricultural research agencies
(June 25, 1947, ch. 125, § 5, as added Pub. L. 92–516, § 2, Oct. 21, 1972, 86 Stat. 983; amended Pub. L. 94–140, § 10, Nov. 28, 1975, 89 Stat. 754; Pub. L. 95–396, § 10, Sept. 30, 1978, 92 Stat. 828; Pub. L. 100–532, title VIII, § 801(d), (q)(1)(D), Oct. 25, 1988, 102 Stat. 2681, 2683; Pub. L. 102–237, title X, § 1006(b)(1), Dec. 13, 1991, 105 Stat. 1895; Pub. L. 116–8, § 4, Mar. 8, 2019, 133 Stat. 487.)

CITE AS: 7 USC 136c

§ 136d. Administrative review; suspension
(a) Existing stocks and information
(1) Existing stocks
(2) Information
(b) Cancellation and change in classificationIf it appears to the Administrator that a pesticide or its labeling or other material required to be submitted does not comply with the provisions of this subchapter or, when used in accordance with widespread and commonly recognized practice, generally causes unreasonable adverse effects on the environment, the Administrator may issue a notice of the Administrator’s intent either—
(1) to cancel its registration or to change its classification together with the reasons (including the factual basis) for the Administrator’s action, or
(2) to hold a hearing to determine whether or not its registration should be canceled or its classification changed.
Such notice shall be sent to the registrant and made public. In determining whether to issue any such notice, the Administrator shall include among those factors to be taken into account the impact of the action proposed in such notice on production and prices of agricultural commodities, retail food prices, and otherwise on the agricultural economy. At least 60 days prior to sending such notice to the registrant or making public such notice, whichever occurs first, the Administrator shall provide the Secretary of Agriculture with a copy of such notice and an analysis of such impact on the agricultural economy. If the Secretary comments in writing to the Administrator regarding the notice and analysis within 30 days after receiving them, the Administrator shall publish in the Federal Register (with the notice) the comments of the Secretary and the response of the Administrator with regard to the Secretary’s comments. If the Secretary does not comment in writing to the Administrator regarding the notice and analysis within 30 days after receiving them, the Administrator may notify the registrant and make public the notice at any time after such 30-day period notwithstanding the foregoing 60-day time requirement. The time requirements imposed by the preceding 3 sentences may be waived or modified to the extent agreed upon by the Administrator and the Secretary. Notwithstanding any other provision of this subsection and section 136w(d) of this title, in the event that the Administrator determines that suspension of a pesticide registration is necessary to prevent an imminent hazard to human health, then upon such a finding the Administrator may waive the requirement of notice to and consultation with the Secretary of Agriculture pursuant to this subsection and of submission to the Scientific Advisory Panel pursuant to section 136w(d) of this title and proceed in accordance with subsection (c). When a public health use is affected, the Secretary of Health and Human Services should provide available benefits and use information, or an analysis thereof, in accordance with the procedures followed and subject to the same conditions as the Secretary of Agriculture in the case of agricultural pesticides. The proposed action shall become final and effective at the end of 30 days from receipt by the registrant, or publication, of a notice issued under paragraph (1), whichever occurs later, unless within that time either (i) the registrant makes the necessary corrections, if possible, or (ii) a request for a hearing is made by a person adversely affected by the notice. In the event a hearing is held pursuant to such a request or to the Administrator’s determination under paragraph (2), a decision pertaining to registration or classification issued after completion of such hearing shall be final. In taking any final action under this subsection, the Administrator shall consider restricting a pesticide’s use or uses as an alternative to cancellation and shall fully explain the reasons for these restrictions, and shall include among those factors to be taken into account the impact of such final action on production and prices of agricultural commodities, retail food prices, and otherwise on the agricultural economy, and the Administrator shall publish in the Federal Register an analysis of such impact.
(c) Suspension
(1) Order
(2) Expedite hearing
(3) Emergency order
(4) Judicial review
(d) Public hearings and scientific review
(e) Conditional registration
(1) The Administrator shall issue a notice of intent to cancel a registration issued under section 136a(c)(7) of this title if (A) the Administrator, at any time during the period provided for satisfaction of any condition imposed, determines that the registrant has failed to initiate and pursue appropriate action toward fulfilling any condition imposed, or (B) at the end of the period provided for satisfaction of any condition imposed, that condition has not been met. The Administrator may permit the continued sale and use of existing stocks of a pesticide whose conditional registration has been canceled under this subsection to such extent, under such conditions, and for such uses as the Administrator may specify if the Administrator determines that such sale or use is not inconsistent with the purposes of this subchapter and will not have unreasonable adverse effects on the environment.
(2) A cancellation proposed under this subsection shall become final and effective at the end of thirty days from receipt by the registrant of the notice of intent to cancel unless during that time a request for hearing is made by a person adversely affected by the notice. If a hearing is requested, a hearing shall be conducted under subsection (d) of this section. The only matters for resolution at that hearing shall be whether the registrant has initiated and pursued appropriate action to comply with the condition or conditions within the time provided or whether the condition or conditions have been satisfied within the time provided, and whether the Administrator’s determination with respect to the disposition of existing stocks is consistent with this subchapter. A decision after completion of such hearing shall be final. Notwithstanding any other provision of this section, a hearing shall be held and a determination made within seventy-five days after receipt of a request for such hearing.
(f) General provisions
(1) Voluntary cancellation
(A) A registrant may, at any time, request that a pesticide registration of the registrant be canceled or amended to terminate one or more pesticide uses.
(B) Before acting on a request under subparagraph (A), the Administrator shall publish in the Federal Register a notice of the receipt of the request and provide for a 30-day period in which the public may comment.
(C) In the case of a pesticide that is registered for a minor agricultural use, if the Administrator determines that the cancellation or termination of uses would adversely affect the availability of the pesticide for use, the Administrator—
(i) shall publish in the Federal Register a notice of the receipt of the request and make reasonable efforts to inform persons who so use the pesticide of the request; and
(ii) may not approve or reject the request until the termination of the 180-day period beginning on the date of publication of the notice in the Federal Register, except that the Administrator may waive the 180-day period upon the request of the registrant or if the Administrator determines that the continued use of the pesticide would pose an unreasonable adverse effect on the environment.
(D) Subject to paragraph (3)(B), after complying with this paragraph, the Administrator may approve or deny the request.
(2) Publication of notice
(3) Transfer of registration of pesticides registered for minor agricultural usesIn the case of a pesticide that is registered for a minor agricultural use:
(A) During the 180-day period referred to in paragraph (1)(C)(ii), the registrant of the pesticide may notify the Administrator of an agreement between the registrant and a person or persons (including persons who so use the pesticide) to transfer the registration of the pesticide, in lieu of canceling or amending the registration to terminate the use.
(B) An application for transfer of registration, in conformance with any regulations the Administrator may adopt with respect to the transfer of the pesticide registrations, must be submitted to the Administrator within 30 days of the date of notification provided pursuant to subparagraph (A). If such an application is submitted, the Administrator shall approve the transfer and shall not approve the request for voluntary cancellation or amendment to terminate use unless the Administrator determines that the continued use of the pesticide would cause an unreasonable adverse effect on the environment.
(C) If the Administrator approves the transfer and the registrant transfers the registration of the pesticide, the Administrator shall not cancel or amend the registration to delete the use or rescind the transfer of the registration, during the 180-day period beginning on the date of the approval of the transfer unless the Administrator determines that the continued use of the pesticide would cause an unreasonable adverse effect on the environment.
(D) The new registrant of the pesticide shall assume the outstanding data and other requirements for the pesticide that are pending at the time of the transfer.
(4) Utilization of data for voluntarily canceled pesticide
(g) Notice for stored pesticides with canceled or suspended registrations
(1) In generalAny producer or exporter of pesticides, registrant of a pesticide, applicant for registration of a pesticide, applicant for or holder of an experimental use permit, commercial applicator, or any person who distributes or sells any pesticide, who possesses any pesticide which has had its registration canceled or suspended under this section shall notify the Administrator and appropriate State and local officials of—
(A) such possession,
(B) the quantity of such pesticide such person possesses, and
(C) the place at which such pesticide is stored.
(2) Copies
(h) Judicial review
(June 25, 1947, ch. 125, § 6, as added Pub. L. 92–516, § 2, Oct. 21, 1972, 86 Stat. 984; amended Pub. L. 94–140, § 1, Nov. 28, 1975, 89 Stat. 751; Pub. L. 95–251, § 2(a)(2), Mar. 27, 1978, 92 Stat. 183; Pub. L. 95–396, §§ 11, 12, Sept. 30, 1978, 92 Stat. 828; Pub. L. 98–620, title IV, § 402(4)(A), Nov. 8, 1984, 98 Stat. 3357; Pub. L. 100–532, title II, § 201, title IV, § 404, title VIII, § 801(e), (q)(2)(B), Oct. 25, 1988, 102 Stat. 2668, 2673, 2681, 2683; Pub. L. 101–624, title XIV, § 1494, Nov. 28, 1990, 104 Stat. 3628; Pub. L. 102–237, title X, § 1006(a)(5), (b)(1), (2), (3)(C)–(E), Dec. 13, 1991, 105 Stat. 1895, 1896; Pub. L. 104–170, title I, §§ 102, 106(a), title II, §§ 210(g), (h), 233, Aug. 3, 1996, 110 Stat. 1489, 1491, 1500, 1509.)

CITE AS: 7 USC 136d

§ 136e. Registration of establishments
(a) Requirement
(b) Registration
(c) Information required
(1) Any producer operating an establishment registered under this section shall inform the Administrator within 30 days after it is registered of the types and amounts of pesticides and, if applicable, active ingredients used in producing pesticides—
(A) which the producer is currently producing;
(B) which the producer has produced during the past year; and
(C) which the producer has sold or distributed during the past year.
The information required by this paragraph shall be kept current and submitted to the Administrator annually as required under such regulations as the Administrator may prescribe.
(2) Any such producer shall, upon the request of the Administrator for the purpose of issuing a stop sale order pursuant to section 136k of this title, inform the Administrator of the name and address of any recipient of any pesticide produced in any registered establishment which the producer operates.
(d) Confidential records and information
(June 25, 1947, ch. 125, § 7, as added Pub. L. 92–516, § 2, Oct. 21, 1972, 86 Stat. 987; amended Pub. L. 95–396, § 13, Sept. 30, 1978, 92 Stat. 829; Pub. L. 102–237, title X, § 1006(b)(1), (3)(F), (G), Dec. 13, 1991, 105 Stat. 1895, 1896.)

CITE AS: 7 USC 136e

§ 136f. Books and records
(a) Requirements
(b) Inspection
(June 25, 1947, ch. 125, § 8, as added Pub. L. 92–516, § 2, Oct. 21, 1972, 86 Stat. 987; amended Pub. L. 95–396, § 14, Sept. 30, 1978, 92 Stat. 829; Pub. L. 100–532, title III, § 301, Oct. 25, 1988, 102 Stat. 2668; Pub. L. 102–237, title X, § 1006(b)(1), Dec. 13, 1991, 105 Stat. 1895.)

CITE AS: 7 USC 136f

§ 136g. Inspection of establishments, etc.
(a) In general
(1) For purposes of enforcing the provisions of this subchapter, officers or employees of the Environmental Protection Agency or of any State duly designated by the Administrator are authorized to enter at reasonable times (A) any establishment or other place where pesticides or devices are held for distribution or sale for the purpose of inspecting and obtaining samples of any pesticides or devices, packaged, labeled, and released for shipment, and samples of any containers or labeling for such pesticides or devices, or (B) any place where there is being held any pesticide the registration of which has been suspended or canceled for the purpose of determining compliance with section 136q of this title.
(2) Before undertaking such inspection, the officers or employees must present to the owner, operator, or agent in charge of the establishment or other place where pesticides or devices are held for distribution or sale, appropriate credentials and a written statement as to the reason for the inspection, including a statement as to whether a violation of the law is suspected. If no violation is suspected, an alternate and sufficient reason shall be given in writing. Each such inspection shall be commenced and completed with reasonable promptness. If the officer or employee obtains any samples, prior to leaving the premises, the officer or employee shall give to the owner, operator, or agent in charge a receipt describing the samples obtained and, if requested, a portion of each such sample equal in volume or weight to the portion retained. If an analysis is made of such samples, a copy of the results of such analysis shall be furnished promptly to the owner, operator, or agent in charge.
(b) Warrants
For purposes of enforcing the provisions of this subchapter and upon a showing to an officer or court of competent jurisdiction that there is reason to believe that the provisions of this subchapter have been violated, officers or employees duly designated by the Administrator are empowered to obtain and to execute warrants authorizing—
(1) entry, inspection, and copying of records for purposes of this section or section 136f of this title;
(2) inspection and reproduction of all rec­ords showing the quantity, date of shipment, and the name of consignor and consignee of any pesticide or device found in the establishment which is adulterated, misbranded, not registered (in the case of a pesticide) or otherwise in violation of this subchapter and in the event of the inability of any person to produce records containing such information, all other records and information relating to such delivery, movement, or holding of the pesticide or device; and
(3) the seizure of any pesticide or device which is in violation of this subchapter.
(c) Enforcement
(1) Certification of facts to Attorney General
(2) Notice not required
(3) Warning notices
(June 25, 1947, ch. 125, § 9, as added Pub. L. 92–516, § 2, Oct. 21, 1972, 86 Stat. 988; amended Pub. L. 100–532, title III, § 302, Oct. 25, 1988, 102 Stat. 2669; Pub. L. 102–237, title X, § 1006(b)(1), (3)(H), (I), Dec. 13, 1991, 105 Stat. 1895, 1896.)

CITE AS: 7 USC 136g

§ 136h. Protection of trade secrets and other information
(a) In general
(b) Disclosure
(c) Disputes
(d) Limitations
(1) All information concerning the objectives, methodology, results, or significance of any test or experiment performed on or with a registered or previously registered pesticide or its separate ingredients, impurities, or degradation products, and any information concerning the effects of such pesticide on any organism or the behavior of such pesticide in the environment, including, but not limited to, data on safety to fish and wildlife, humans and other mammals, plants, animals, and soil, and studies on persist­ence, translocation and fate in the environment, and metabolism, shall be available for disclosure to the public. The use of such data for any registration purpose shall be governed by section 136a of this title. This paragraph does not authorize the disclosure of any information that—
(A) discloses manufacturing or quality control processes,
(B) discloses the details of any methods for testing, detecting, or measuring the quantity of any deliberately added inert ingredient of a pesticide, or
(C) discloses the identity or percentage quantity of any deliberately added inert ingredient of a pesticide,
unless the Administrator has first determined that disclosure is necessary to protect against an unreasonable risk of injury to health or the environment.
(2) Information concerning production, distribution, sale, or inventories of a pesticide that is otherwise entitled to confidential treatment under subsection (b) of this section may be publicly disclosed in connection with a public proceeding to determine whether a pesticide, or any ingredient of a pesticide, causes unreasonable adverse effects on health or the environment, if the Administrator determines that such disclosure is necessary in the public interest.
(3) If the Administrator proposes to disclose information described in clause (A), (B), or (C) of paragraph (1) or in paragraph (2) of this subsection, the Administrator shall notify by certified mail the submitter of such information of the intent to release such information. The Administrator may not release such information, without the submitter’s consent, until thirty days after the submitter has been furnished such notice. Where the Administrator finds that disclosure of information described in clause (A), (B), or (C) of paragraph (1) of this subsection is necessary to avoid or lessen an imminent and substantial risk of injury to the public health, the Administrator may set such shorter period of notice (but not less than ten days) and such method of notice as the Administrator finds appropriate. During such period the data submitter may institute an action in an appropriate district court to enjoin or limit the proposed disclosure. The court may enjoin disclosure, or limit the disclosure or the parties to whom disclosure shall be made, to the extent that—
(A) in the case of information described in clause (A), (B), or (C) of paragraph (1) of this subsection, the proposed disclosure is not required to protect against an unreasonable risk of injury to health or the environment; or
(B) in the case of information described in paragraph (2) of this subsection, the public interest in availability of the information in the public proceeding does not outweigh the interests in preserving the confidentiality of the information.
(e) Disclosure to contractors
(f) Penalty for disclosure by Federal employees
(1) Any officer or employee of the United States or former officer or employee of the United States who, by virtue of such employment or official position, has obtained possession of, or has access to, material the disclosure of which is prohibited by subsection (b) of this section, and who, knowing that disclosure of such material is prohibited by such subsection, willfully discloses the material in any manner to any person not entitled to receive it, shall be fined not more than $10,000 or imprisoned for not more than one year, or both. Section 1905 of title 18 shall not apply with respect to the publishing, divulging, disclosure, or making known of, or making available, information reported or otherwise obtained under this subchapter. Nothing in this subchapter shall preempt any civil remedy under State or Federal law for wrongful disclosure of trade secrets.
(2) For the purposes of this section, any contractor with the United States who is furnished information as authorized by subsection (e) of this section, or any employee of any such contractor, shall be considered to be an employee of the United States.
(g) Disclosure to foreign and multinational pesticide producers
(1) The Administrator shall not knowingly disclose information submitted by an applicant or registrant under this subchapter to any employee or agent of any business or other entity engaged in the production, sale, or distribution of pesticides in countries other than the United States or in addition to the United States or to any other person who intends to deliver such data to such foreign or multinational business or entity unless the applicant or registrant has consented to such disclosure. The Administrator shall require an affirmation from any person who intends to inspect data that such person does not seek access to the data for purposes of delivering it or offering it for sale to any such business or entity or its agents or employees and will not purposefully deliver or negligently cause the data to be delivered to such business or entity or its agents or employees. Notwithstanding any other provision of this subsection, the Administrator may disclose information to any person in connection with a public proceeding under law or regulation, subject to restrictions on the availability of information contained elsewhere in this subchapter, which information is relevant to a determination by the Administrator with respect to whether a pesticide, or any ingredient of a pesticide, causes unreasonable adverse effects on health or the environment.
(2) The Administrator shall maintain records of the names of persons to whom data are disclosed under this subsection and the persons or organizations they represent and shall inform the applicant or registrant of the names and affiliations of such persons.
(3)Section 1001 of title 18 shall apply to any affirmation made under paragraph (1) of this subsection.
(June 25, 1947, ch. 125, § 10, as added Pub. L. 92–516, § 2, Oct. 21, 1972, 86 Stat. 989; amended Pub. L. 95–396, § 15, Sept. 30, 1978, 92 Stat. 829; Pub. L. 98–620, title IV, § 402(4)(B), Nov. 8, 1984, 98 Stat. 3357; Pub. L. 100–532, title VIII, § 801(f), Oct. 25, 1988, 102 Stat. 2682; Pub. L. 102–237, title X, § 1006(b)(1), (2), (3)(J), Dec. 13, 1991, 105 Stat. 1895, 1896.)

CITE AS: 7 USC 136h

§ 136i. Use of restricted use pesticides; applicators
(a) Certification procedure
(1) Federal certification
(2) State certification
If any State, at any time, desires to certify applicators of pesticides, the Governor of such State shall submit a State plan for such purpose. The Administrator shall approve the plan submitted by any State, or any modification thereof, if such plan in the Administrator’s judgment—
(A) designates a State agency as the agency responsible for administering the plan throughout the State;
(B) contains satisfactory assurances that such agency has or will have the legal authority and qualified personnel necessary to carry out the plan;
(C) gives satisfactory assurances that the State will devote adequate funds to the administration of the plan;
(D) provides that the State agency will make such reports to the Administrator in such form and containing such information as the Administrator may from time to time require; and
(E) contains satisfactory assurances that State standards for the certification of applicators of pesticides conform with those standards prescribed by the Administrator under paragraph (1).
Any State certification program under this section shall be maintained in accordance with the State plan approved under this section.
(b) State plans
(c) Instruction in integrated pest management techniques
(d) In general
(e) Separate standards
(June 25, 1947, ch. 125, § 11, formerly §§ 4, 11, as added Pub. L. 92–516, § 2, Oct. 21, 1972, 86 Stat. 983, 989; amended Pub. L. 94–140, §§ 5, 11, Nov. 28, 1975, 89 Stat. 753, 754; Pub. L. 95–396, § 9, Sept. 30, 1978, 92 Stat. 827; Pub. L. 100–532, title VIII, § 801(c), (q)(1)(A)–(C), Oct. 25, 1988, 102 Stat. 2681, 2683; Pub. L. 102–237, title X, § 1006(a)(6), (b)(1), (2), (3)(K), Dec. 13, 1991, 105 Stat. 1895, 1896.)

CITE AS: 7 USC 136i

§ 136i–1. Pesticide recordkeeping
(a) Requirements
(1) The Secretary of Agriculture, in consultation with the Administrator of the Environmental Protection Agency, shall require certified applicators of restricted use pesticides (of the type described under section 136a(d)(1)(C) of this title) to maintain records comparable to records maintained by commercial applicators of pesticides in each State. If there is no State requirement for the maintenance of records, such applicator shall maintain records that contain the product name, amount, approximate date of application, and location of application of each such pesticide used for a 2-year period after such use.
(2) Within 30 days of a pesticide application, a commercial certified applicator shall provide a copy of records maintained under paragraph (1) to the person for whom such application was provided.
(b) Access
(c) Health care personnel
(d) Penalty
The Secretary of Agriculture shall be responsible for the enforcement of subsections (a), (b), and (c). A violation of such subsection shall—
(1) in the case of the first offense, be subject to a fine of not more than $500; and
(2) in the case of subsequent offenses, be subject to a fine of not less than $1,000 for each violation, except that the penalty shall be less than $1,000 if the Secretary determines that the person made a good faith effort to comply with such subsection.
(e) Federal or State provisions
(f) Surveys and reports
(g) Regulations
(Pub. L. 101–624, title XIV, § 1491, Nov. 28, 1990, 104 Stat. 3627; Pub. L. 102–237, title X, § 1006(d), Dec. 13, 1991, 105 Stat. 1896.)

CITE AS: 7 USC 136i-1

§ 136i–2. Collection of pesticide use information
(a) In general
(b) Collection
(c) Coordination
(Pub. L. 104–170, title III, § 302, Aug. 3, 1996, 110 Stat. 1512.)

CITE AS: 7 USC 136i-2

§ 136j. Unlawful acts
(a) In general
(1) Except as provided by subsection (b), it shall be unlawful for any person in any State to distribute or sell to any person—
(A) any pesticide that is not registered under section 136a of this title or whose registration has been canceled or suspended, except to the extent that distribution or sale otherwise has been authorized by the Administrator under this subchapter;
(B) any registered pesticide if any claims made for it as a part of its distribution or sale substantially differ from any claims made for it as a part of the statement required in connection with its registration under section 136a of this title;
(C) any registered pesticide the composition of which differs at the time of its distribution or sale from its composition as described in the statement required in connection with its registration under section 136a of this title;
(D) any pesticide which has not been colored or discolored pursuant to the provisions of section 136w(c)(5) of this title;
(E) any pesticide which is adulterated or misbranded; or
(F) any device which is misbranded.
(2) It shall be unlawful for any person—
(A) to detach, alter, deface, or destroy, in whole or in part, any labeling required under this subchapter;
(B) to refuse to—
(i) prepare, maintain, or submit any records required by or under section 136c, 136e, 136f, 136i, or 136q of this title;
(ii) submit any reports required by or under section 136c, 136d, 136e, 136f, 136i, or 136q of this title; or
(iii) allow any entry, inspection, copying of records, or sampling authorized by this subchapter;
(C) to give a guaranty or undertaking provided for in subsection (b) which is false in any particular, except that a person who receives and relies upon a guaranty authorized under subsection (b) may give a guaranty to the same effect, which guaranty shall contain, in addition to the person’s own name and address, the name and address of the person residing in the United States from whom the person received the guaranty or undertaking;
(D) to use for the person’s own advantage or to reveal, other than to the Administrator, or officials or employees of the Environmental Protection Agency or other Federal executive agencies, or to the courts, or to physicians, pharmacists, and other qualified persons, needing such information for the performance of their duties, in accordance with such directions as the Administrator may prescribe, any information acquired by authority of this subchapter which is confidential under this subchapter;
(E) who is a registrant, wholesaler, dealer, retailer, or other distributor to advertise a product registered under this subchapter for restricted use without giving the classification of the product assigned to it under section 136a of this title;
(F) to distribute or sell, or to make available for use, or to use, any registered pesticide classified for restricted use for some or all purposes other than in accordance with section 136a(d) of this title and any regulations thereunder, except that it shall not be unlawful to sell, under regulations issued by the Administrator, a restricted use pesticide to a person who is not a certified applicator for application by a certified applicator;
(G) to use any registered pesticide in a manner inconsistent with its labeling;
(H) to use any pesticide which is under an experimental use permit contrary to the provisions of such permit;
(I) to violate any order issued under section 136k of this title;
(J) to violate any suspension order issued under section 136a(c)(2)(B), 136a–1, or 136d of this title;
(K) to violate any cancellation order issued under this subchapter or to fail to submit a notice in accordance with section 136d(g) of this title;
(L) who is a producer to violate any of the provisions of section 136e of this title;
(M) to knowingly falsify all or part of any application for registration, application for experimental use permit, any information submitted to the Administrator pursuant to section 136e of this title, any records required to be maintained pursuant to this subchapter, any report filed under this subchapter, or any information marked as confidential and submitted to the Administrator under any provision of this subchapter;
(N) who is a registrant, wholesaler, dealer, retailer, or other distributor to fail to file reports required by this subchapter;
(O) to add any substance to, or take any substance from, any pesticide in a manner that may defeat the purpose of this subchapter;
(P) to use any pesticide in tests on human beings unless such human beings (i) are fully informed of the nature and purposes of the test and of any physical and mental health consequences which are reasonably foreseeable therefrom, and (ii) freely volunteer to participate in the test;
(Q) to falsify all or part of any information relating to the testing of any pesticide (or any ingredient, metabolite, or degradation product thereof), including the nature of any protocol, procedure, substance, organism, or equipment used, observation made, or conclusion or opinion formed, submitted to the Administrator, or that the person knows will be furnished to the Administrator or will become a part of any records required to be maintained by this subchapter;
(R) to submit to the Administrator data known to be false in support of a registration; or
(S) to violate any regulation issued under section 136a(a) or 136q of this title.
(b) ExemptionsThe penalties provided for a violation of paragraph (1) of subsection (a) shall not apply to—
(1) any person who establishes a guaranty signed by, and containing the name and address of, the registrant or person residing in the United States from whom the person purchased or received in good faith the pesticide in the same unbroken package, to the effect that the pesticide was lawfully registered at the time of sale and delivery to the person, and that it complies with the other requirements of this subchapter, and in such case the guarantor shall be subject to the penalties which would otherwise attach to the person holding the guaranty under the provisions of this subchapter;
(2) any carrier while lawfully shipping, transporting, or delivering for shipment any pesticide or device, if such carrier upon request of any officer or employee duly designated by the Administrator shall permit such officer or employee to copy all of its records concerning such pesticide or device;
(3) any public official while engaged in the performance of the official duties of the public official;
(4) any person using or possessing any pesticide as provided by an experimental use permit in effect with respect to such pesticide and such use or possession; or
(5) any person who ships a substance or mixture of substances being put through tests in which the purpose is only to determine its value for pesticide purposes or to determine its toxicity or other properties and from which the user does not expect to receive any benefit in pest control from its use.
(June 25, 1947, ch. 125, § 12, as added Pub. L. 92–516, § 2, Oct. 21, 1972, 86 Stat. 989; amended Pub. L. 95–396, § 16, Sept. 30, 1978, 92 Stat. 832; Pub. L. 100–532, title VI, §§ 601(b)(2), 603, title VIII, § 801(g), (q)(2)(B), Oct. 25, 1988, 102 Stat. 2677, 2678, 2682, 2683; Pub. L. 102–237, title X, § 1006(a)(7), (b)(3)(L)–(O), Dec. 13, 1991, 105 Stat. 1895, 1896.)

CITE AS: 7 USC 136j

§ 136k. Stop sale, use, removal, and seizure
(a) Stop sale, etc., orders
(b) SeizureAny pesticide or device that is being transported or, having been transported, remains unsold or in original unbroken packages, or that is sold or offered for sale in any State, or that is imported from a foreign country, shall be liable to be proceeded against in any district court in the district where it is found and seized for confiscation by a process in rem for condemnation if—
(1) in the case of a pesticide—
(A) it is adulterated or misbranded;
(B) it is not registered pursuant to the provisions of section 136a of this title;
(C) its labeling fails to bear the information required by this subchapter;
(D) it is not colored or discolored and such coloring or discoloring is required under this subchapter; or
(E) any of the claims made for it or any of the directions for its use differ in substance from the representations made in connection with its registration;
(2) in the case of a device, it is misbranded; or
(3) in the case of a pesticide or device, when used in accordance with the requirements imposed under this subchapter and as directed by the labeling, it nevertheless causes unreasonable adverse effects on the environment.
In the case of a plant regulator, defoliant, or desiccant, used in accordance with the label claims and recommendations, physical or physiological effects on plants or parts thereof shall not be deemed to be injury, when such effects are the purpose for which the plant regulator, defoliant, or desiccant was applied.
(c) Disposition after condemnation
(d) Court costs, etc.
(June 25, 1947, ch. 125, § 13, as added Pub. L. 92–516, § 2, Oct. 21, 1972, 86 Stat. 991; amended Pub. L. 100–532, title VIII, § 801(h), Oct. 25, 1988, 102 Stat. 2682.)

CITE AS: 7 USC 136k

§ 136l. Penalties
(a) Civil penalties
(1) In general
(2) Private applicator
(3) Hearing
(4) Determination of penalty
(5) References to Attorney General
(b) Criminal penalties
(1) In general
(A) Any registrant, applicant for a registration, or producer who knowingly violates any provision of this subchapter shall be fined not more than $50,000 or imprisoned for not more than 1 year, or both.
(B) Any commercial applicator of a restricted use pesticide, or any other person not described in subparagraph (A) who distributes or sells pesticides or devices, who knowingly violates any provision of this subchapter shall be fined not more than $25,000 or imprisoned for not more than 1 year, or both.
(2) Private applicator
(3) Disclosure of information
(4) Acts of officers, agents, etc.
(June 25, 1947, ch. 125, § 14, as added Pub. L. 92–516, § 2, Oct. 21, 1972, 86 Stat. 992; amended Pub. L. 95–396, § 17, Sept. 30, 1978, 92 Stat. 832; Pub. L. 100–532, title VI, § 604, Oct. 25, 1988, 102 Stat. 2678; Pub. L. 102–237, title X, § 1006(a)(8), Dec. 13, 1991, 105 Stat. 1895.)

CITE AS: 7 USC 136l

§ 136m. Indemnities
(a) General indemnification
(1) In generalExcept as otherwise provided in this section, if—
(A) the Administrator notifies a registrant under section 136d(c)(1) of this title that the Administrator intends to suspend a registration or that an emergency order of suspension of a registration under section 136d(c)(3) of this title has been issued;
(B) the registration in question is suspended under section 136d(c) of this title, and thereafter is canceled under section 136d(b), 136d(d), or 136d(f) of this title; and
(C) any person who owned any quantity of the pesticide immediately before the notice to the registrant under subparagraph (A) suffered losses by reason of suspension or cancellation of the registration;
the Administrator shall make an indemnity payment to the person.
(2) ExceptionParagraph (1) shall not apply if the Administrator finds that the person—
(A) had knowledge of facts that, in themselves, would have shown that the pesticide did not meet the requirements of section 136a(c)(5) of this title for registration; and
(B) continued thereafter to produce the pesticide without giving timely notice of such facts to the Administrator.
(3) ReportIf the Administrator takes an action under paragraph (1) that requires the payment of indemnification, the Administrator shall report to the Committee on Agriculture of the House of Representatives, the Committee on Agriculture, Nutrition, and Forestry of the Senate, and the Committees on Appropriations of the House of Representatives and the Senate on—
(A) the action taken that requires the payment of indemnification;
(B) the reasons for taking the action;
(C) the estimated cost of the payment; and
(D) a request for the appropriation of funds for the payment.
(4) Appropriation
(b) Indemnification of end users, dealers, and distributors
(1) End usersIf—
(A) the Administrator notifies a registrant under section 136d(c)(1) of this title that the Administrator intends to suspend a registration or that an emergency order of suspension of a registration under section 136d(c)(3) of this title has been issued;
(B) the registration in question is suspended under section 136d(c) of this title, and thereafter is canceled under section 136d(b), 136d(d), or 136d(f) of this title; and
(C) any person who, immediately before the notice to the registrant under subparagraph (A), owned any quantity of the pesticide for purposes of applying or using the pesticide as an end user, rather than for purposes of distributing or selling it or further processing it for distribution or sale, suffered a loss by reason of the suspension or cancellation of the pesticide;
the person shall be entitled to an indemnity payment under this subsection for such quantity of the pesticide.
(2) Dealers and distributors
(A) Any registrant, wholesaler, dealer, or other distributor (hereinafter in this paragraph referred to as a “seller”) of a registered pesticide who distributes or sells the pesticide directly to any person not described as an end user in paragraph (1)(C) shall, with respect to any quantity of the pesticide that such person cannot use or resell as a result of the suspension or cancellation of the pesticide, reimburse such person for the cost of first acquiring the pesticide from the seller (other than the cost of transportation, if any), unless the seller provided to the person at the time of distribution or sale a notice, in writing, that the pesticide is not subject to reimbursement by the seller.
(B) If—
(i) the Administrator notifies a registrant under section 136d(c)(1) of this title that the Administrator intends to suspend a registration or that an emergency order of suspension of a registration under section 136d(c)(3) of this title has been issued;
(ii) the registration in question is suspended under section 136d(c) of this title, and thereafter is canceled under section 136d(b), 136d(d), or 136d(f) of this title;
(iii) any person who, immediately before the notice to the registrant under clause (i)—(I) had not been notified in writing by the seller, as provided under subparagraph (A), that any quantity of the pesticide owned by such person is not subject to reimbursement by the seller in the event of suspension or cancellation of the pesticide; and(II) owned any quantity of the pesticide for purposes of—(aa) distributing or selling it; or(bb) further processing it for distribution or sale directly to an end user;
suffered a loss by reason of the suspension or cancellation of the pesticide; and
(iv) the Administrator determines on the basis of a claim of loss submitted to the Administrator by the person, that the seller—(I) did not provide the notice specified in subparagraph (A) to such person; and(II) is and will continue to be unable to provide reimbursement to such person, as provided under subparagraph (A), for the loss referred to in clause (iii), as a result of the insolvency or bankruptcy of the seller and the seller’s resulting inability to provide such reimbursement;
the person shall be entitled to an indemnity payment under this subsection for such quantity of the pesticide.
(C) If an indemnity payment is made by the United States under this paragraph, the United States shall be subrogated to any right that would otherwise be held under this paragraph by a seller who is unable to make a reimbursement in accordance with this paragraph with regard to reimbursements that otherwise would have been made by the seller.
(3) Source
(4) Administrative settlement
(c) Amount of payment
(1) In general
(2) Special rule
(June 25, 1947, ch. 125, § 15, as added Pub. L. 92–516, § 2, Oct. 21, 1972, 86 Stat. 993; amended Pub. L. 100–532, title V, § 501(a), Oct. 25, 1988, 102 Stat. 2674.)

CITE AS: 7 USC 136m

§ 136n. Administrative procedure; judicial review
(a) District court review
(b) Review by court of appeals
(c) Jurisdiction of district courts
(d) Notice of judgments
(June 25, 1947, ch. 125, § 16, as added Pub. L. 92–516, § 2, Oct. 21, 1972, 86 Stat. 994; amended Pub. L. 98–620, title IV, § 402(4)(C), Nov. 8, 1984, 98 Stat. 3357; Pub. L. 100–532, title VIII, § 801(i), Oct. 25, 1988, 102 Stat. 2682; Pub. L. 102–237, title X, § 1006(b)(1), (2), (3)(P), Dec. 13, 1991, 105 Stat. 1895, 1896.)

CITE AS: 7 USC 136n

§ 136o. Imports and exports
(a) Pesticides and devices intended for export
Notwithstanding any other provision of this subchapter, no pesticide or device or active ingredient used in producing a pesticide intended solely for export to any foreign country shall be deemed in violation of this subchapter—
(1) when prepared or packed according to the specifications or directions of the foreign purchaser, except that producers of such pesticides and devices and active ingredients used in producing pesticides shall be subject to sections 136(p), 136(q)(1)(A), (C), (D), (E), (G), and (H), 136(q)(2)(A), (B), (C)(i) and (iii), and (D), 136e, and 136f of this title; and
(2) in the case of any pesticide other than a pesticide registered under section 136a or sold under section 136d(a)(1) of this title, if, prior to export, the foreign purchaser has signed a statement acknowledging that the purchaser understands that such pesticide is not registered for use in the United States and cannot be sold in the United States under this subchapter.
A copy of that statement shall be transmitted to an appropriate official of the government of the importing country.
(b) Cancellation notices furnished to foreign governments
(c) Importation of pesticides and devices
(1) In general
(2) Importation of seed
Notwithstanding any other provision of law, no person is required to notify the Administrator of the arrival of a plant-incorporated protectant (as defined in section 174.3 of title 40, Code of Federal Regulations (or any successor regulation)) that is contained in a seed, if—
(A) that plant-incorporated protectant is registered under section 136a of this title;
(B) the Administrator has issued an experimental use permit for that plant-incorporated protectant under section 136c of this title; or
(C) the seed is covered by a permit (as defined in part 340 of title 7, Code of Federal Regulations (or any successor regulation)) or a notification.
(3) Cooperation
(A) In general
(B) Contents
(4) Applicability
Nothing in this subsection precludes or limits the authority of the Secretary of Agriculture with respect to the importation or movement of plants, plant products, or seeds under—
(A) the Plant Protection Act (7 U.S.C. 7701 et seq.); and
(B) the Federal Seed Act (7 U.S.C. 1551 et seq.).
(d) Cooperation in international efforts
(1) In general
(2) Department of State expenses
(e) Regulations
(June 25, 1947, ch. 125, § 17, as added Pub. L. 92–516, § 2, Oct. 21, 1972, 86 Stat. 995; amended Pub. L. 95–396, § 18(a), Sept. 30, 1978, 92 Stat. 833; Pub. L. 100–532, title VIII, § 801(j), Oct. 25, 1988, 102 Stat. 2682; Pub. L. 102–237, title X, § 1006(a)(9), (b)(2), Dec. 13, 1991, 105 Stat. 1895; Pub. L. 110–234, title XIV, § 14209(a), May 22, 2008, 122 Stat. 1463; Pub. L. 110–246, § 4(a), title XIV, § 14209(a), June 18, 2008, 122 Stat. 1664, 2225; Pub. L. 113–79, title X, § 10008, Feb. 7, 2014, 128 Stat. 948.)

CITE AS: 7 USC 136o

§ 136p. Exemption of Federal and State agencies

The Administrator may, at the Administrator’s discretion, exempt any Federal or State agency from any provision of this subchapter if the Administrator determines that emergency conditions exist which require such exemption. The Administrator, in determining whether or not such emergency conditions exist, shall consult with the Secretary of Agriculture and the Governor of any State concerned if they request such determination.

(June 25, 1947, ch. 125, § 18, as added Pub. L. 92–516, § 2, Oct. 21, 1972, 86 Stat. 995; amended Pub. L. 94–140, § 8, Nov. 28, 1975, 89 Stat. 754; Pub. L. 100–532, title VIII, § 801(k), Oct. 25, 1988, 102 Stat. 2682; Pub. L. 102–237, title X, § 1006(b)(1), (2), Dec. 13, 1991, 105 Stat. 1895.)

CITE AS: 7 USC 136p

§ 136q. Storage, disposal, transportation, and recall
(a) Storage, disposal, and transportation
(1) Data requirements and registration of pesticidesThe Administrator may require under section 136a or 136d of this title that—
(A) the registrant or applicant for registration of a pesticide submit or cite data or information regarding methods for the safe storage and disposal of excess quantities of the pesticide to support the registration or continued registration of a pesticide;
(B) the labeling of a pesticide contain requirements and procedures for the transportation, storage, and disposal of the pesticide, any container of the pesticide, any rinsate containing the pesticide, or any other material used to contain or collect excess or spilled quantities of the pesticide; and
(C) the registrant of a pesticide provide evidence of sufficient financial and other resources to carry out a recall plan under subsection (b), and provide for the disposition of the pesticide, in the event of suspension and cancellation of the pesticide.
(2) PesticidesThe Administrator may by regulation, or as part of an order issued under section 136d of this title or an amendment to such an order—
(A) issue requirements and procedures to be followed by any person who stores or transports a pesticide the registration of which has been suspended or canceled;
(B) issue requirements and procedures to be followed by any person who disposes of stocks of a pesticide the registration of which has been suspended; and
(C) issue requirements and procedures for the disposal of any pesticide the registration of which has been canceled.
(3) Containers, rinsates, and other materialsThe Administrator may by regulation, or as part of an order issued under section 136d of this title or an amendment to such an order—
(A) issue requirements and procedures to be followed by any person who stores or transports any container of a pesticide the registration of which has been suspended or canceled, any rinsate containing the pesticide, or any other material used to contain or collect excess or spilled quantities of the pesticide;
(B) issue requirements and procedures to be followed by any person who disposes of stocks of any container of a pesticide the registration of which has been suspended, any rinsate containing the pesticide, or any other material used to contain or collect excess or spilled quantities of the pesticide; and
(C) issue requirements and procedures for the disposal of any container of a pesticide the registration of which has been canceled, any rinsate containing the pesticide, or any other material used to contain or collect excess or spilled quantities of the pesticide.
(4) Container recycling
(b) Recalls
(1) In general
(2) Voluntary recall
(3) Mandatory recall
(4) Recall procedureA regulation issued under this subsection may require any person that is subject to the regulation to—
(A) arrange to make available one or more storage facilities to receive and store the pesticide to which the recall program applies, and inform the Administrator of the location of each such facility;
(B) accept and store at such a facility those existing stocks of such pesticide that are tendered by any other person who obtained the pesticide directly or indirectly from the person that is subject to such regulation;
(C) on the request of a person making such a tender, provide for proper transportation of the pesticide to a storage facility; and
(D) take such reasonable steps as the regulation may prescribe to inform persons who may be holders of the pesticide of the terms of the recall regulation and how those persons may tender the pesticide and arrange for transportation of the pesticide to a storage facility.
(5) Contents of recall planA recall plan established under this subsection shall include—
(A) the level in the distribution chain to which the recall is to extend, and a schedule for recall; and
(B) the means to be used to verify the effectiveness of the recall.
(6) Requirements or procedures
(c) Storage costs
(1) Submission of plan
(2) ReimbursementWithin a reasonable period of time after such storage costs are incurred and paid by the registrant, the Administrator shall reimburse the registrant, on request, for—
(A) none of the costs incurred by the registrant before the date of submission of the plan referred to in paragraph (1) to the Administrator;
(B) 100 percent of the costs incurred by the registrant after the date of submission of the plan to the Administrator or the date of cancellation of the registration of the pesticide, whichever is later, but before the approval of the plan by the Administrator;
(C) 50 percent of the costs incurred by the registrant during the 1-year period beginning on the date of the approval of the plan by the Administrator or the date of cancellation of the registration of the pesticide, whichever is later;
(D) none of the costs incurred by the registrant during the 3-year period beginning on the 366th day following approval of the plan by the Administrator or the date of cancellation of the registration of the pesticide, whichever is later; and
(E) 25 percent of the costs incurred by the registrant during the period beginning on the first day of the 5th year following the date of the approval of the plan by the Administrator or the date of cancellation of the registration of the pesticide, whichever is later, and ending on the date that a disposal permit for the pesticide is issued by a State or an alternative plan for disposal of the pesticide in accordance with applicable law has been developed.
(d) Administration of storage, disposal, transportation, and recall programs
(1) Voluntary agreements
(2) Rule and regulation review
(3) Limitations
(4) Seizure and penalties
(e) Container design
(1) Procedures
(A) Not later than 3 years after the effective date of this subsection, the Administrator shall, in consultation with the heads of other interested Federal agencies, promulgate regulations for the design of pesticide containers that will promote the safe storage and disposal of pesticides.
(B) The regulations shall ensure, to the fullest extent practicable, that the containers—
(i) accommodate procedures used for the removal of pesticides from the containers and the rinsing of the containers;
(ii) facilitate the safe use of the containers, including elimination of splash and leakage of pesticides from the containers;
(iii) facilitate the safe disposal of the containers; and
(iv) facilitate the safe refill and reuse of the containers.
(2) Compliance
(f) Pesticide residue removal
(1) Procedures
(A) Not later than 3 years after the effective date of this subsection, the Administrator shall, in consultation with the heads of other interested Federal agencies, promulgate regulations prescribing procedures and standards for the removal of pesticides from containers prior to disposal.
(B) The regulations may—
(i) specify, for each major type of pesticide container, procedures and standards providing for, at a minimum, triple rinsing or the equivalent degree of pesticide removal;
(ii) specify procedures that can be implemented promptly and easily in various circumstances and conditions;
(iii) provide for reuse, whenever practicable, or disposal of rinse water and residue; and
(iv) be coordinated with requirements for the rinsing of containers imposed under the Solid Waste Disposal Act (42 U.S.C. 6901 et seq.).
(C) The Administrator may, at the discretion of the Administrator, exempt products intended solely for household use from the requirements of this subsection.
(2) Compliance
(3) Solid Waste Disposal Act
(g) Pesticide container study
(1) Study
(A) The Administrator shall conduct a study of options to encourage or require—
(i) the return, refill, and reuse of pesticide containers;
(ii) the development and use of pesticide formulations that facilitate the removal of pesticide residues from containers; and
(iii) the use of bulk storage facilities to reduce the number of pesticide containers requiring disposal.
(B) In conducting the study, the Administrator shall—
(i) consult with the heads of other interested Federal agencies, State agencies, industry groups, and environmental organizations; and
(ii) assess the feasibility, costs, and environmental benefits of encouraging or requiring various measures or actions.
(2) Report
(h) Relationship to Solid Waste Disposal Act
(1) In general
(2) Antimicrobial products
(June 25, 1947, ch. 125, § 19, as added Pub. L. 92–516, § 2, Oct. 21, 1972, 86 Stat. 995; amended Pub. L. 95–396, § 19, Sept. 30, 1978, 92 Stat. 833; Pub. L. 100–532, title IV, §§ 401–403, title VIII, § 801(q)(1)(D), Oct. 25, 1988, 102 Stat. 2669, 2672, 2683; Pub. L. 104–170, title II, § 225, Aug. 3, 1996, 110 Stat. 1507; Pub. L. 110–234, title XIV, § 14209(b), May 22, 2008, 122 Stat. 1463; Pub. L. 110–246, § 4(a), title XIV, § 14209(b), June 18, 2008, 122 Stat. 1664, 2225.)

CITE AS: 7 USC 136q

§ 136r. Research and monitoring
(a) Research
(b) National monitoring plan
(c) Monitoring
(June 25, 1947, ch. 125, § 20, as added Pub. L. 92–516, § 2, Oct. 21, 1972, 86 Stat. 996; amended Pub. L. 95–396, § 20,

CITE AS: 7 USC 136r

§ 136r–1. Integrated Pest Management

The Secretary of Agriculture, in cooperation with the Administrator, shall implement research, demonstration, and education programs to support adoption of Integrated Pest Management. Integrated Pest Management is a sustainable approach to managing pests by combining biological, cultural, physical, and chemical tools in a way that minimizes economic, health, and environmental risks. The Secretary of Agriculture and the Administrator shall make information on Integrated Pest Management widely available to pesticide users, including Federal agencies. Federal agencies shall use Integrated Pest Management techniques in carrying out pest management activities and shall promote Integrated Pest Management through procurement and regulatory policies, and other activities.

(Pub. L. 104–170, title III, § 303, Aug. 3, 1996, 110 Stat. 1512.)

CITE AS: 7 USC 136r-1

§ 136s. Solicitation of comments; notice of public hearings
(a) Secretary of Agriculture
(b) Secretary of Health and Human Services
(c) Views
(d) Notice
(June 25, 1947, ch. 125, § 21, as added Pub. L. 92–516, § 2, Oct. 21, 1972, 86 Stat. 996; amended Pub. L. 94–140, § 2(b), Nov. 28, 1975, 89 Stat. 752; Pub. L. 100–532, title VIII, § 801(l), Oct. 25, 1988, 102 Stat. 2682; Pub. L. 102–237, title X, § 1006(b)(1), (2), Dec. 13, 1991, 105 Stat. 1895; Pub. L. 104–170, title II, § 234, Aug. 3, 1996, 110 Stat. 1509.)

CITE AS: 7 USC 136s

§ 136t. Delegation and cooperation
(a) Delegation
(b) Cooperation
(June 25, 1947, ch. 125, § 22, as added Pub. L. 92–516, § 2, Oct. 21, 1972, 86 Stat. 996.)

CITE AS: 7 USC 136t

§ 136u. State cooperation, aid, and training
(a) Cooperative agreements
The Administrator may enter into cooperative agreements with States and Indian tribes—
(1) to delegate to any State or Indian tribe the authority to cooperate in the enforcement of this subchapter through the use of its personnel or facilities, to train personnel of the State or Indian tribe to cooperate in the enforcement of this subchapter, and to assist States and Indian tribes in implementing cooperative enforcement programs through grants-in-aid; and
(2) to assist States in developing and administering State programs, and Indian tribes that enter into cooperative agreements, to train and certify applicators consistent with the standards the Administrator prescribes.
Effective with the fiscal year beginning October 1, 1978, there are authorized to be appropriated annually such funds as may be necessary for the Administrator to provide through cooperative agreements an amount equal to 50 percent of the anticipated cost to each State or Indian tribe, as agreed to under such cooperative agreements, of conducting training and certification programs during such fiscal year. If funds sufficient to pay 50 percent of the costs for any year are not appropriated, the share of each State and Indian tribe shall be reduced in a like proportion in allocating available funds.
(b) Contracts for training
(c) Information and education
(June 25, 1947, ch. 125, § 23, as added Pub. L. 92–516, § 2, Oct. 21, 1972, 86 Stat. 996; amended Pub. L. 95–396, § 21, Sept. 30, 1978, 92 Stat. 834.)

CITE AS: 7 USC 136u

§ 136v. Authority of States
(a) In general
(b) Uniformity
(c) Additional uses
(1) A State may provide registration for additional uses of federally registered pesticides formulated for distribution and use within that State to meet special local needs in accord with the purposes of this subchapter and if registration for such use has not previously been denied, disapproved, or canceled by the Administrator. Such registration shall be deemed registration under section 136a of this title for all purposes of this subchapter, but shall authorize distribution and use only within such State.
(2) A registration issued by a State under this subsection shall not be effective for more than ninety days if disapproved by the Administrator within that period. Prior to disapproval, the Administrator shall, except as provided in paragraph (3) of this subsection, advise the State of the Administrator’s intention to disapprove and the reasons therefor, and provide the State time to respond. The Administrator shall not prohibit or disapprove a registration issued by a State under this subsection (A) on the basis of lack of essentiality of a pesticide or (B) except as provided in paragraph (3) of this subsection, if its composition and use patterns are similar to those of a federally registered pesticide.
(3) In no instance may a State issue a registration for a food or feed use unless there exists a tolerance or exemption under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] that permits the residues of the pesticides on the food or feed. If the Administrator determines that a registration issued by a State is inconsistent with the Federal Food, Drug, and Cosmetic Act, or the use of, a pesticide under a registration issued by a State constitutes an imminent hazard, the Administrator may immediately disapprove the registration.
(4) If the Administrator finds, in accordance with standards set forth in regulations issued under section 136w of this title, that a State is not capable of exercising adequate controls to assure that State registration under this section will be in accord with the purposes of this subchapter or has failed to exercise adequate controls, the Administrator may suspend the authority of the State to register pesticides until such time as the Administrator is satisfied that the State can and will exercise adequate controls. Prior to any such suspension, the Administrator shall advise the State of the Administrator’s intention to suspend and the reasons therefor and provide the State time to respond.
(June 25, 1947, ch. 125, § 24, as added Pub. L. 92–516, § 2, Oct. 21, 1972, 86 Stat. 997; amended Pub. L. 95–396, § 22, Sept. 30, 1978, 92 Stat. 835; Pub. L. 100–532, title VIII, § 801(m), Oct. 25, 1988, 102 Stat. 2682.)

CITE AS: 7 USC 136v

§ 136w. Authority of Administrator
(a) In general
(1) Regulations
(2) Procedure
(A) Proposed regulations
(B) Final regulations
(C) Time requirements
(D) Publication in the Federal Register
(3) Congressional committees
(4) Congressional review of regulations
(b) Exemption of pesticides
(c) Other authority
The Administrator, after notice and opportunity for hearing, is authorized—
(1) to declare a pest any form of plant or animal life (other than man and other than bacteria, virus, and other micro-organisms on or in living man or other living animals) which is injurious to health or the environment;
(2) to determine any pesticide which contains any substance or substances in quantities highly toxic to man;
(3) to establish standards (which shall be consistent with those established under the authority of the Poison Prevention Packaging Act (Public Law 91–601) [15 U.S.C. 1471 et seq.]) with respect to the package, container, or wrapping in which a pesticide or device is enclosed for use or consumption, in order to protect children and adults from serious injury or illness resulting from accidental ingestion or contact with pesticides or devices regulated by this subchapter as well as to accomplish the other purposes of this subchapter;
(4) to specify those classes of devices which shall be subject to any provision of section 136(q)(1) or section 136e of this title upon the Administrator’s determination that application of such provision is necessary to effectuate the purposes of this subchapter;
(5) to prescribe regulations requiring any pesticide to be colored or discolored if the Administrator determines that such requirement is feasible and is necessary for the protection of health and the environment; and
(6) to determine and establish suitable names to be used in the ingredient statement.
(d) Scientific advisory panel
(1) In general
(2) Science Review Board
(e) Peer review
(June 25, 1947, ch. 125, § 25, as added Pub. L. 92–516, § 2, Oct. 21, 1972, 86 Stat. 997; amended Pub. L. 94–140, §§ 2(a), 6, 7, Nov. 28, 1975, 89 Stat. 751, 753; Pub. L. 95–396, § 23, Sept. 30, 1978, 92 Stat. 836; Pub. L. 96–539, §§ 1, 2(a), 4, Dec. 17, 1980, 94 Stat. 3194, 3195; Pub. L. 98–201, § 1, Dec. 2, 1983, 97 Stat. 1379; Pub. L. 98–620, title IV, § 402(4)(D), Nov. 8, 1984, 98 Stat. 3357; Pub. L. 100–352, § 6(i), June 27, 1988, 102 Stat. 664; Pub. L. 100–532, title VI, §§ 602, 605, title VIII, § 801(n), Oct. 25, 1988, 102 Stat. 2678, 2679, 2683; Pub. L. 102–237, title X, § 1006(b)(1), (2), Dec. 13, 1991, 105 Stat. 1895; Pub. L. 104–170, title I, § 104, title II, § 235, Aug. 3, 1996, 110 Stat. 1490, 1509.)

CITE AS: 7 USC 136w

§ 136w–1. State primary enforcement responsibility
(a) In general
For the purposes of this subchapter, a State shall have primary enforcement responsibility for pesticide use violations during any period for which the Administrator determines that such State—
(1) has adopted adequate pesticide use laws and regulations, except that the Administrator may not require a State to have pesticide use laws that are more stringent than this subchapter;
(2) has adopted and is implementing adequate procedures for the enforcement of such State laws and regulations; and
(3) will keep such records and make such reports showing compliance with paragraphs (1) and (2) of this subsection as the Administrator may require by regulation.
(b) Special rules
(c) Administrator
(June 25, 1947, ch. 125, § 26, as added Pub. L. 95–396, § 24(2), Sept. 30, 1978, 92 Stat. 836; amended Pub. L. 100–532, title VIII, § 801(o), (q)(1)(D), Oct. 25, 1988, 102 Stat. 2683; Pub. L. 102–237, title X, § 1006(a)(11), Dec. 13, 1991, 105 Stat. 1895.)

CITE AS: 7 USC 136w-1

§ 136w–2. Failure by the State to assure enforcement of State pesticide use regulations
(a) Referral
(b) Notice
(c) Construction
(June 25, 1947, ch. 125, § 27, as added Pub. L. 95–396, § 24(2), Sept. 30, 1978, 92 Stat. 837; amended Pub. L. 100–532, title VIII, § 801(p), Oct. 25, 1988, 102 Stat. 2683.)

CITE AS: 7 USC 136w-2

§ 136w–3. Identification of pests; cooperation with Department of Agriculture’s program
(a) In general
(b) Pest control availability
(1) In general
The Administrator, in cooperation with the Secretary of Agriculture, shall identify—
(A) available methods of pest control by crop or animal;
(B) minor pest control problems, both in minor crops and minor or localized problems in major crops; and
(C) factors limiting the availability of specific pest control methods, such as resistance to control methods and regulatory actions limiting the availability of control methods.
(2) Report
The Secretary of Agriculture shall, not later than 180 days after November 28, 1990, and annually thereafter, prepare a report and send the report to the Administrator. The report shall—
(A) contain the information described in paragraph (1);
(B) identify the crucial pest control needs where a shortage of control methods is indicated by the information described in paragraph (1); and
(C) describe in detail research and extension efforts designed to address the needs identified in subparagraph (B).
(c) Integrated pest management
(d) Public health pests
(June 25, 1947, ch. 125, § 28, as added Pub. L. 95–396, § 24(2), Sept. 30, 1978, 92 Stat. 838; amended Pub. L. 101–624, title XIV, § 1495, Nov. 28, 1990, 104 Stat. 3629; Pub. L. 104–127, title VIII, § 862(b)(1), Apr. 4, 1996, 110 Stat. 1174; Pub. L. 104–170, title II, § 236, Aug. 3, 1996, 110 Stat. 1509.)

CITE AS: 7 USC 136w-3

§ 136w–4. Omitted

CITE AS: 7 USC 136w-4

§ 136w–5. Minimum requirements for training of maintenance applicators and service technicians

Each State may establish minimum requirements for training of maintenance applicators and service technicians. Such training may include instruction in the safe and effective handling and use of pesticides in accordance with the Environmental Protection Agency approved labeling, and instruction in integrated pest management techniques. The authority of the Administrator with respect to minimum requirements for training of maintenance applicators and service technicians shall be limited to ensuring that each State understands the provisions of this section.

(June 25, 1947, ch. 125, § 30, as added Pub. L. 104–170, title I, § 121(2), Aug. 3, 1996, 110 Stat. 1492.)

CITE AS: 7 USC 136w-5

§ 136w–6. Environmental Protection Agency minor use program
(a) The Administrator shall assure coordination of minor use issues through the establishment of a minor use program within the Office of Pesticide Programs. Such office shall be responsible for coordinating the development of minor use programs and policies and consulting with growers regarding minor use issues and registrations and amendments which are submitted to the Environmental Protection Agency.
(b) The Office of Pesticide Programs shall prepare a public report concerning the progress made on the registration of minor uses, including implementation of the exclusive use as an incentive for registering new minor uses, within 3 years of the passage of the Food Quality Protection Act of 1996.
(June 25, 1947, ch. 125, § 31, as added Pub. L. 104–170, title II, § 210(i), Aug. 3, 1996, 110 Stat. 1500.)

CITE AS: 7 USC 136w-6

§ 136w–7. Department of Agriculture minor use program
(a) In general
The Secretary of Agriculture (hereinafter in this section referred to as the “Secretary”) shall assure the coordination of the responsibilities of the Department of Agriculture related to minor uses of pesticides, including—
(1) carrying out the Inter-Regional Project Number 4 (IR–4) as described in section 2 of Public Law 89–106 (7 U.S.C. 450i(e)) 1
1 See References in Text note below.
and the national pesticide resistance monitoring program established under section 1651 1 of the Food, Agriculture, Conservation, and Trade Act of 1990 (7 U.S.C. 5882);
(2) supporting integrated pest management research;
(3) consulting with growers to develop data for minor uses; and
(4) providing assistance for minor use registrations, tolerances, and reregistrations with the Environmental Protection Agency.
(b) Minor use pesticide data and revolving fund
(1) Minor use pesticide data
(A) Grant authority
(B) Applicants
(C) Data ownership
(2) Minor Use Pesticide Data Revolving Fund
(A) Establishment
(B) Contents of the Fund
There shall be deposited in the Fund—
(i) such amounts as may be appropriated to support the purposes of this subsection; and
(ii) fees collected by the Secretary for any data developed under a grant under paragraph (1)(A).
(C) Authorizations of appropriations
(June 25, 1947, ch. 125, § 32, as added Pub. L. 104–170, title II, § 210(j), Aug. 3, 1996, 110 Stat. 1501.)

CITE AS: 7 USC 136w-7

§ 136w–8. Pesticide registration service fees
(a) Definition of costsIn this section, the term “costs”, when used with respect to review and decisionmaking pertaining to an application for which registration service fees are paid under this section, means—
(1) costs to the extent that—
(A) officers and employees provide direct support for the review and decisionmaking for covered pesticide applications, associated tolerances, and corresponding risk and benefits information and analyses;
(B) persons and organizations under contract with the Administrator engage in the review of the applications, and corresponding risk and benefits information and assessments; and
(C) advisory committees and other accredited persons or organizations, on the request of the Administrator, engage in the peer review of risk or benefits information associated with covered pesticide applications;
(2) costs of management of information, and the acquisition, maintenance, and repair of computer and telecommunication resources (including software), used to support review of pesticide applications, associated tolerances, and corresponding risk and benefits information and analyses; and
(3) costs of collecting registration service fees under subsections (b) and (c) and reporting, auditing, and accounting under this section.
(b) Fees
(1) In general
(2) Covered applications
(A) In general
(B) Existing applications
(i) In general
(ii) Tolerance or exemption fees
(C) DocumentationAn application subject to a registration service fee under this section shall be submitted with documentation certifying—
(i) payment of the registration service fee; or
(ii) payment of at least 25 percent of the registration service fee and a request for a waiver from or reduction of the remaining amount of the registration service fee.
(D) Payment
(E) Applications subject to additional feesAn application may be subject to additional fees if—
(i) the applicant identified the incorrect registration service fee and decision review period;
(ii) after review of a waiver request, the Administrator denies the waiver request; or
(iii) on completion of, where appropriate, the initial screening of the contents of the application or the preliminary technical screening of the application, the Administrator determines that a different registration service fee and decision review period apply to the application.
(F) Effect of failure to pay fees
(G) Non-refundable portion of fees
(i) In general
(ii) Limitation
(H) Collection of unpaid fees
(3) Schedule of covered applications and other actions and their registration service fees
(A) Data evaluation recordsAt the decision review time under a fee table specified in subparagraph (B) or as agreed upon under subsection (f)(5), for each covered application under a fee table specified in such subparagraph (B), the Administrator shall—
(i) complete data evaluation records for studies submitted by the applicant in support of the application; and
(ii) release those data evaluation records to the applicant, using appropriate protections for confidential business information.
(B) Schedule, actions, and fees
(4) Pending pesticide registration applications
(A) In general
(B) Voluntary fee
(C) DocumentationAn application for which a voluntary registration service fee is paid under this paragraph shall be submitted with documentation certifying—
(i) payment of the registration service fee; or
(ii) a request for a waiver from or reduction of the registration service fee.
(5) Resubmission of covered applications
(6) Fee adjustment
(A) In general
(B) Additional adjustment
(C) Publication
(7) Waivers and reductions
(A) In general
(B) Documentation
(i) In general
(ii) Certification
(iii) Inaccurate documentationAn application shall be subject to the applicable registration service fee payable under paragraph (3)(B) if, at any time, the Administrator determines that—(I) the documentation supporting the waiver or reduction request is not accurate; or(II) based on the documentation or any other information, the waiver or reduction should not have been granted or should not be granted.
(C) Determination to grant or deny requestAs soon as practicable, but not later than 60 days, after the date on which the Administrator receives a request for a waiver or reduction of a registration service fee under this paragraph, the Administrator shall—
(i) determine whether to grant or deny the request; and
(ii) notify the applicant of the determination.
(D) Minor uses
(i) In general
(ii) Supporting documentation
(E) IR–4 exemptionThe Administrator shall exempt an application from the registration service fee if the Administrator determines that—
(i) the application is solely associated with a tolerance petition submitted in connection with the Inter-Regional Project Number 4 (IR–4) as described in section 2 of Public Law 89–106 (7 U.S.C. 450i(e)); 1 and
(ii) the exemption is in the public interest.
(F) Small businesses
(i) In general
(ii) Waiver of feesThe Administrator shall waive 75 percent of the registration service fees payable by an entity under this section if the entity—(I) is a small business (as defined in section 136a–1(i)(1)(E)(ii) of this title) at the time of application; and(II) has average annual global gross revenues described in section 136a–1(i)(1)(E)(ii)(I)(bb) of this title that does not exceed $10,000,000, at the time of application.
(iii) Formation for waiver
(iv) DocumentationAn entity requesting a waiver under this subparagraph shall provide to the Administrator—(I) documentation demonstrating that the entity is a small business (as defined in section 136a–1(i)(1)(E)(ii) of this title) at the time of application; and(II) if the entity is requesting a waiver of 75 percent of the applicable registration service fees payable under this section, documentation demonstrating that the entity has an average annual global gross revenue described in section 136a–1(i)(1)(E)(ii)(I)(bb) of this title that does not exceed $10,000,000, at the time of application.
(G) Federal and State agency exemptions
(8) Refunds
(A) Early withdrawals
(B) Withdrawals after the first 60 days of decision review time period
(i) In general
(ii) TimingThe Administrator shall—(I) make the determination described in clause (i) not later than 90 days after the date the application is withdrawn; and(II) provide any refund as soon as practicable after the determination.
(C) Discretionary refunds
(i) In general
(ii) BasisThe Administrator may provide a refund for an application under this subparagraph—(I) on the basis that, in reviewing the application, the Administrator has considered data submitted in support of another covered application;(II) on the basis that the Administrator completed portions of the review of the application before the effective date of this section; or(III) on the basis that the Administrator rejected the application under subsection (f)(4)(B).
(D) Credited fees
(c) Pesticide Registration Fund
(1) EstablishmentThere is established in the Treasury of the United States a Pesticide Registration Fund to be used in carrying out this section (referred to in this section as the “Fund”), consisting of—
(A) such amounts as are deposited in the Fund under paragraph (2);
(B) any interest earned on investment of amounts in the Fund under paragraph (5); and
(C) any proceeds from the sale or redemption of investments held in the Fund.
(2) Deposits in Fund
(3) Expenditures from Fund
(A) In generalSubject to subparagraphs (B) and (C) and paragraph (4), the Administrator may make expenditures from the Fund—
(i) to cover the costs associated with the review and decisionmaking pertaining to all applications for which registration service fees have been paid under this section; and
(ii) to otherwise carry out this section.
(B) Endangered species review of outdoor use of pesticide products
(i) In general
(ii) Deadlines for guidanceThe Administrator shall issue final guidance required by clause (i) in accordance with the following:(I) With respect to new active ingredients or any registration review decision proposed for 1 or more outdoor uses, not later than 9 months after December 29, 2022.(II) With respect to new outdoor uses of a registered pesticide, not later than 1 year after December 29, 2022.(III) With respect to antimicrobial pesticide products, not later than 3 years after December 29, 2022.
(C) Independent third party assessments
(i) In general
(ii) Workforce assessment(I) In general(II) ReportNot later than 2 years after December 29, 2022—(aa) the contractor selected under subclause (I) shall submit to the Administrator a report describing—(AA) the findings from the assessment under that subclause; and(BB) recommendations for improved methodologies to represent full-time equivalent resources described in that subclause; and(bb) the Administrator shall publish the report submitted under item (aa) on the website of the Environmental Protection Agency.
(iii) Process assessment(I) In general(aa) ContractsWithin 1 year of December 29, 2022, to the extent practicable, the Administrator shall issue a competitive contract to a private, independent consulting firm—(AA) to conduct the assessment described in subclause (II); and(BB) to submit to the Administrator a report describing the findings of the assessment and the processes and performance of the Environmental Protection Agency relating to the implementation of the Pesticide Registration Improvement Act of 2022 and the amendments made by that Act.(bb) Eligibility(II) Assessment(aa) In general(bb) Consultation(cc) RequirementsThe assessment under item (aa) shall evaluate and make recommendations regarding—(AA) the initial span screen;(BB) the preliminary technical screen;(CC) performance, processes, and progress toward reducing renegotiation rates and the average length of renegotiations;(DD) performance, processes, and progress toward eliminating the backlog of registrant submissions not covered by subsection (b)(3);(EE) performance, processes, and progress toward ensuring that all registrant submissions not covered by subsection (b)(3) are completed by the applicable deadlines described in the notice of the Administrator entitled “Pesticide Registration Notice (PR) 98–10: Notifications, Non-Notifications and Minor Formulation Amendments” and dated October 22, 1998 (and any successor amendments to that notice) and described in subsections (c)(3)(B) and (h) of section 136a of this title;(FF) compliance with the provisions of this subchapter relating to renegotiations and registrant submissions not covered by subsection (b)(3);(GG) information technology systems;(HH) recommended improvements to employee training;(II) performance, progress, and processes in completing registration review; and(JJ) other appropriate issues, such as submissions by inert suppliers and fast-track amendments under subsections (c)(3)(B) and (h) of section 136a of this title.(III) Report to CongressNot later than 1 year after the receipt of an assessment required under this section, the Administrator shall submit to the Committee on Agriculture, Nutrition, and Forestry of the Senate and the Committee on Agriculture of the House of Representatives—(aa) a copy of each such assessment; and(bb) the Administrator’s evaluation of the findings and recommendations contained in each such assessment.(IV) RecommendationsThe Administrator shall include with the report submitted under subclause (III) a classification of each recommendation described in the report as—(aa) can be implemented through administrative action of the Administrator; or(bb) requires a statutory change.
(4) Collections and appropriations ActsThe fees authorized by this section and amounts deposited in the Fund—
(A) shall be collected and made available for obligation only to the extent provided in advance in appropriations Acts;
(B) shall be available during periods in which Environmental Protection Agency employees are on shutdown or emergency furlough as a result of a lapse in appropriations; and
(C) shall be available without fiscal year limitation.
(5) Unused funds
(A) In generalAmounts in the Fund not currently needed to carry out this section shall be—
(i) maintained readily available or on deposit;
(ii) invested in obligations of the United States or guaranteed by the United States; or
(iii) invested in obligations, participations, or other instruments that are lawful investments for fiduciary, trust, or public funds.
(B) Use of investment income
(d) Assessment of fees
(1) Definition of covered functions
(2) Minimum amount of appropriations
(3) Use of fees
(4) Subsequent authority
(e) Reforms to reduce decision time review periods and prevent double payment of registration fees
(1) Reduction of decision time review periods
(2) Prevention of double payment of registration service fees
(f) Decision time review periods
(1) In general
(2) Report
(3) Applications subject to decision time review periodsThe decision time review periods specified in paragraph (1) shall apply to—
(A) covered pesticide registration applications subject to registration service fees under subsection (b)(2);
(B) covered pesticide registration applications for which an applicant has voluntarily paid registration service fees under subsection (b)(4); and
(C) applications for any other action covered by a table specified in subsection (b)(3)(B).
(4) Start of decision time review period
(A) In general
(B) Initial span and preliminary technical screenings
(i) Screenings(I) Initial span(II) Preliminary technical screeningAfter conducting the initial span screening described in subclause (I) and in accordance with clause (iv), the Administrator shall conduct a preliminary technical screening—(aa) not later than 45 days after the date on which the decision time review period begins (for applications with decision time review periods of not more than 180 days); and(bb) not later than 90 days after the date on which the decision time review period begins (for applications with decision time review periods greater than 180 days).(III) Final fee category
(ii) Rejection(I) In general(II) Written notification
(iii) Requirements of initial span screeningIn conducting an initial span screening of an application, the Administrator shall automate the process, to the maximum extent practicable, and determine whether—(I)(aa) the applicable registration service fee has been paid; or(bb) at least 25 percent of the applicable registration service fee has been paid and the application contains a waiver or refund request for the outstanding amount and documentation establishing the basis for the waiver request; and(II) the application appears to contain all the necessary forms, data, and draft labeling, formatted in accordance with guidance published by the Administrator.
(iv) Requirements of preliminary technical screeningIn conducting a preliminary technical screening of an application, the Administrator shall—(I) determine if the application and the data and information submitted with the application are accurate and complete;(II) determine if the application, data, and information are consistent with the proposed labeling and any proposal for a tolerance or exemption from the requirement for a tolerance under section 408 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a), and are such that, subject to full review under the standards of this subchapter, could result in the granting of the application;(III) determine, if applicable, whether an application qualifies for a reduced risk determination under subsection (c)(10) or (h) of section 136a of this title;(IV) grant or deny any data waiver requests submitted by the applicant with the application;(V) verify and validate the accuracy of the fee category selected by the applicant; and(VI) notify the applicant, in writing, if a new or different fee category is required and calculate the new decision review time based on the original submission date.
(C) Applications with waiver or reduction requests
(i) In general
(ii) Request granted with no additional fees requiredIf the Administrator grants the waiver or reduction request and no additional fee is required, the decision time review period begins on the earlier of—(I) the date on which the Administrator grants the request; or(II) the date that is 60 days after the date of receipt of the application.
(iii) Request granted with additional fees required
(iv) Request denied
(D) Pending applications
(i) In general
(ii) ApplicationsClause (i) applies to—(I) covered pesticide registration applications for which voluntary fees have been paid under subsection (b)(4); and(II) covered pesticide registration applications received on or after the effective date of the Pesticide Registration Improvement Act of 2003 but submitted without the applicable registration service fee required under this section due to the inability of the Administrator to assess fees under subsection (d)(1).
(E) Applications for reduced risk
(i) Fee
(ii) Decision review time period
(5) Extension of decision time review period
(A) NotificationIf the Administrator cannot meet a decision time review period under this subsection, the Administrator shall notify the applicant, in writing, of—
(i) the reasons why additional time is needed; and
(ii) the number of days needed that would allow the Administrator to make a regulatory decision.
(B) Extension by negotiation or mutual agreementThe Administrator, acting solely through the Director of the Office of Pesticide Programs, and the applicant may mutually agree, in writing, to extend a decision time review period under this subsection if—
(i) there is new or additional data or information from the applicant that is necessary for the Administrator to make a decision on the application that cannot be made available within the original decision time review period; or
(ii) a public comment period associated with the application generates significant comments that cannot be addressed within the original decision time review period.
(C) Priority
(g) Judicial review
(1) In general
(2) Scope
(A) In general
(B) Other actions
(3) Timing
(A) In general
(B) Meeting with Administrator
(4) Remedies
(h) AccountingThe Administrator shall—
(1) provide an annual accounting of the registration service fees paid to the Administrator and disbursed from the Fund, by providing financial statements in accordance with—
(A) the Chief Financial Officers Act of 1990 (Public Law 101–576; 104 Stat. 2838) and amendments made by that Act; and
(B) the Government Management Reform Act of 1994 (Public Law 103–356; 108 Stat. 3410) and amendments made by that Act;
(2) provide an accounting describing expenditures from the Fund authorized under subsection (c); and
(3) provide an annual accounting describing collections and expenditures authorized under subsection (d).
(i) Auditing
(1) Financial statements of agencies
(2) ComponentsThe annual audit required under sections 3515(b) and 3521 of that title of the financial statements of activities under this section shall include an analysis of—
(A) the fees collected under subsection (b) and disbursed;
(B) compliance with subsection (f);
(C) the amount appropriated to meet the requirements of subsection (d)(1); and
(D) the reasonableness of the allocation of the overhead allocation of costs associated with the review and decisionmaking pertaining to applications under this section.
(3) Inspector GeneralThe Inspector General of the Environmental Protection Agency shall—
(A) conduct the annual audit required under this subsection; and
(B) report the findings and recommendations of the audit to the Administrator and to the appropriate committees of Congress.
(j) Personnel levels
(k) Reports and information technology
(1) Reports
(A) In generalNot later than 120 days after the last day of each of fiscal years 2023 through 2027, the Administrator shall publish an annual report describing—
(i) actions taken under this section;
(ii) registrant submissions not covered by subsection (b)(3)(B);
(iii) the initial span and preliminary technical screenings required in subsection (f)(4)(B); and
(iv) staffing relating to implementing the Pesticide Registration Improvement Act of 2022 and the amendments made by that Act.
(B) ContentsEach report published under subparagraph (A) shall include a summary of the following information:
(i) Actions under this sectionTo the extent practicable, data for each action taken under this section that is completed during the fiscal year covered by the report or pending at the conclusion of that fiscal year, organized by registering division, including—(I) the Action Code;(II) the application receipt date;(III) the electronic portal tracking number assigned to the application at the time of submission to the electronic submission portal or the Environmental Protection Agency tracking number;(IV) the original decision due date based on the Action Code;(V) the dates of any renegotiations and the renegotiated due dates, if applicable;(VI) the reasons for each renegotiation, if applicable;(VII) if the submission had to be recoded, reassigned codes, if applicable;(VIII) the date that the submission was recoded, if applicable;(IX) the decision completion date, if the action has been completed;(X) the status of the action, which may be—(aa) failed initial span screen;(bb) failed preliminary technical screen;(cc) approved;(dd) withdrawn;(ee) denied;(ff) do not grant; or(gg) pending;(XI) the reason for any denial or do not grant decision, if applicable;(XII) a review of the progress made in carrying out each requirement of subsections (e) and (f), including, to the extent determined appropriate by the Administrator and consistent with the authorities of the Administrator and limitations on delegation of functions by the Administrator, recommendations for the allowance and use of summaries of acute toxicity studies;(XIII) a review of the progress in carrying out section 136a(g) of this title, including—(aa)3
3 So in original. There is no item (bb).
the number of pesticides or pesticide cases reviewed and the number of registration review decisions completed, including—(AA) the number of cases cancelled;(BB) the number of cases requiring risk mitigation measures;(CC) the number of cases removing risk mitigation measures;(DD) the number of cases with no risk mitigation needed; and(EE) the number of cases in which risk mitigation has been fully implemented;(XIV) a review of the progress made toward implementing enhancements to—(aa) the electronic tracking of conditional registrations; and(bb) the endangered species database;(XV) a review of the progress made in updating the Pesticide Incident Data System, including progress toward making the information contained in the System available to the public (as the Administrator determines is appropriate);(XVI) an assessment of the public availability of summary pesticide usage data;(XVII) the number of the active ingredients approved, new uses, and pesticide end use products granted in connection with the Design for the Environment program (or any successor program) of the Environmental Protection Agency;(XVIII) with respect to funds in the Reregistration and Expedited Processing Fund described under section 136a–1(k) of this title, a review that includes—(aa) a description of the amount and use of such funds—(AA) to carry out activities relating to worker protection under subparagraphs (G) and (H) of section 136a–1(i)(1) of this title;(BB) to award partnership grants under subparagraph (I) of such section; and(CC) to carry out the pesticide safety education program under subparagraph (J) of such section;(bb) an evaluation of the appropriateness and effectiveness of the activities, grants, and program under subparagraphs (G), (H), (I), and (J) of such section;(cc) a description of how stakeholders are engaged in the decision to fund such activities, grants, and program in accordance with the stakeholder input provided under such subparagraphs; and(dd) with respect to activities relating to worker protection carried out under subparagraphs (G) and (H) of section 136a–1(i)(1) of this title, a summary of the analyses from stakeholders, including from worker community-based organizations, on the appropriateness and effectiveness of such activities.(XIX) beginning two years after enactment, report on the progress of meeting the deadlines listed in paragraph (5) of section 136a(f) of this title; and(XX) a review of progress made in implementing the pesticide surveillance program referred to in paragraph (8) of section 136a–1(k) of this title.
(ii) Registrant submissions not covered by subsection (b)(3)(B)Each registrant submission not covered by subsection (b)(3)(B), that is completed during the fiscal year covered by the report or pending at the conclusion of that fiscal year, organized by registering division, including—(I) the submission date;(II) the electronic portal tracking number assigned to the application at the time of the submission of the application to the electronic submission portal;(III) the type of regulatory action, as defined by statute or guidance document, and the specific label action;(IV) the status of the action;(V) the due date;(VI) the reason for the outcome; and(VII) the completion date, if applicable.
(iii) Screening processData for the initial span screens and preliminary technical screens that are completed during the fiscal year covered by the report or pending at the conclusion of that fiscal year, organized by registering division, including—(I) the number of applications successfully passing each type of screen;(II) the number of applications that failed the screening process for each type of screen;(III) the number of notifications issued by the Administrator under subsection (f)(4)(B)(ii)(II);(IV) the number of notifications issued by the Administrator under subsection (f)(4)(B)(ii)(I) and the number of applications resulting in a rejection; and(V) the number of notifications issued under section 152.105 of title 40, Code of Federal Regulations (or successor regulations), and to the extent practicable, the reasons for that issuance.
(iv) StaffingData on the staffing relating to work covered under the Pesticide Registration Improvement Act of 2022 and the amendments made by that Act, organized by registering division, including—(I) the number of new hires and personnel departures;(II) the number of full-time equivalents at the end of each fiscal year;(III) the number of full-time equivalents working on registration review activities; and(IV) the number of full-time equivalents working on registrant submissions not covered by subsection (b)(3)(B).
(C) PublicationThe Administrator shall publish each report under subparagraph (A)—
(i) on the website of the Environmental Protection Agency; and
(ii) by such other methods as the Administrator determines to be the most effective for efficiently disseminating the report.
(2) Information technology
(A) SystemNot later than 1 year after December 29, 2022, the Administrator shall establish an information technology system that—
(i) includes all registering divisions in the Office of Pesticide Programs;
(ii) provides a real-time, accurate, tracking system for all regulatory submissions to the Office of Pesticide Programs;
(iii) provides a 4
4 So in original.
real-time, accessible information 4 that provides each applicant confidential, online access to the status and progress of the regulatory submissions of the applicant; and
(iv) updates the electronic submission portal—(I) to ensure that label reviews are limited to current label changes, to the maximum extent practicable;(II) to automate, to the extent practicable, minor, low risk regulatory actions; and(III) to allow self-certification of certain regulatory actions, as determined by the Administrator.
(B) Access to registration data and decisionsThe Administrator shall implement efforts to expand existing, and develop new, information technology tools and databases to improve access by Environmental Protection Agency employees to data used to fulfill registrations, and public access to information about regulatory decisionmaking tools, including opportunities for—
(i) analysis of the impact of submitted studies on Environmental Protection Agency assessments and decisions;
(ii) facilitation of read-across or computational model development to help fill information gaps;
(iii) tracking and reporting submission and decision metrics relating to the use and acceptance of test methods; and
(iv) drafting and publication of policies communicating Environmental Protection Agency acceptance of novel technologies or approaches.
(l) Savings clause
(m) Termination of effectiveness
(1) In general
(2) Phase out
(A) Fiscal year 2028
(B) Fiscal year 2029
(C)September 30, 2029
(D) Decision review periods
(i) Pending applications
(ii) New applications
(June 25, 1947, ch. 125, § 33, as added Pub. L. 108–199, div. G, title V, § 501(f)(2), Jan. 23, 2004, 118 Stat. 422; amended Pub. L. 110–94, § 5, Oct. 9, 2007, 121 Stat. 1002; Pub. L. 110–193, § 1(a), Mar. 6, 2008, 122 Stat. 649; Pub. L. 112–177, § 2(a)(2)(B), (b), Sept. 28, 2012, 126 Stat. 1328, 1330; Pub. L. 116–8, §§ 5, 6, Mar. 8, 2019, 133 Stat. 487, 491; Pub. L. 117–328, div. HH, title VI, §§ 705, 706, Dec. 29, 2022, 136 Stat. 6008, 6018.)

CITE AS: 7 USC 136w-8

§ 136x. Severability

If any provision of this subchapter or the application thereof to any person or circumstance is held invalid, the invalidity shall not affect other provisions or applications of this subchapter which can be given effect without regard to the invalid provision or application, and to this end the provisions of this subchapter are severable.

(June 25, 1947, ch. 125, § 34, formerly § 26, as added Pub. L. 92–516, § 2, Oct. 21, 1972, 86 Stat. 998; renumbered § 30, Pub. L. 95–396, § 24(1), Sept. 30, 1978, 92 Stat. 836; renumbered § 33, Pub. L. 104–170, title I, § 121(1), Aug. 3, 1996, 110 Stat. 1492; renumbered § 34, Pub. L. 108–199, div. G, title V, § 501(f)(1), Jan. 23, 2004, 118 Stat. 422.)

CITE AS: 7 USC 136x

§ 136y. Authorization of appropriations
There is authorized to be appropriated to carry out this subchapter (other than section 136u(a) of this title)—
(1) $83,000,000 for fiscal year 1989, of which not more than $13,735,500 shall be available for research under this subchapter;
(2) $95,000,000 for fiscal year 1990, of which not more than $14,343,600 shall be available for research under this subchapter; and
(3) $95,000,000 for fiscal year 1991, of which not more than $14,978,200 shall be available for research under this subchapter.
(June 25, 1947, ch. 125, § 35, formerly § 27, as added Pub. L. 92–516, § 2, Oct. 21, 1972, 86 Stat. 998; amended Pub. L. 94–51, July 2, 1975, 89 Stat. 257; Pub. L. 94–109, Oct. 10, 1975, 89 Stat. 571; Pub. L. 94–140, § 3, Nov. 28, 1975, 89 Stat. 752; renumbered § 31 and amended Pub. L. 95–396, §§ 24(1), 25, Sept. 30, 1978, 92 Stat. 836, 838; Pub. L. 96–539, § 3, Dec. 17, 1980, 94 Stat. 3195; Pub. L. 98–201, § 2, Dec. 2, 1983, 97 Stat. 1380; Pub. L. 99–198, title XVII, § 1768, Dec. 23, 1985, 99 Stat. 1656; Pub. L. 100–532, title VII, § 701, Oct. 25, 1988, 102 Stat. 2679; renumbered § 34, Pub. L. 104–170, title I, § 121(1), Aug. 3, 1996, 110 Stat. 1492; renumbered § 35, Pub. L. 108–199, div. G, title V, § 501(f)(1), Jan. 23, 2004, 118 Stat. 422.)

CITE AS: 7 USC 136y