Collapse to view only § 343-2. Dietary supplement labeling exemptions
- § 341. Definitions and standards for food
- § 342. Adulterated food
- § 343. Misbranded food
- § 343-1. National uniform nutrition labeling
- § 343-2. Dietary supplement labeling exemptions
- § 343-3. Disclosure
- § 343a. Repealed.
- § 344. Emergency permit control
- § 345. Regulations making exemptions
- § 346. Tolerances for poisonous or deleterious substances in food; regulations
- § 346a. Tolerances and exemptions for pesticide chemical residues
- § 346b. Authorization of appropriations
- § 347. Intrastate sales of colored oleomargarine
- § 347a. Congressional declaration of policy regarding oleomargarine sales
- § 347b. Contravention of State laws
- § 348. Food additives
- § 349. Bottled drinking water standards; publication in Federal Register
- § 350. Vitamins and minerals
- § 350a. Infant formulas
- § 350a-1. Protecting infants and improving formula supply
- § 350b. New dietary ingredients
- § 350c. Maintenance and inspection of records
- § 350d. Registration of food facilities
- § 350e. Sanitary transportation practices
- § 350f. Reportable food registry
- § 350g. Hazard analysis and risk-based preventive controls
- § 350h. Standards for produce safety
- § 350i. Protection against intentional adulteration
- § 350j. Targeting of inspection resources for domestic facilities, foreign facilities, and ports of entry; annual report
- § 350k. Laboratory accreditation for analyses of foods
- § 350l. Mandatory recall authority
- § 350l-1. Annual report to Congress
- § 350m. Requirements for critical food
§ 341. Definitions and standards for food
Whenever in the judgment of the Secretary such action will promote honesty and fair dealing in the interest of consumers, he shall promulgate regulations fixing and establishing for any food, under its common or usual name so far as practicable, a reasonable definition and standard of identity, a reasonable standard of quality, or reasonable standards of fill of container. No definition and standard of identity and no standard of quality shall be established for fresh or dried fruits, fresh or dried vegetables, or butter, except that definitions and standards of identity may be established for avocadoes, cantaloupes, citrus fruits, and melons. In prescribing any standard of fill of container, the Secretary shall give due consideration to the natural shrinkage in storage and in transit of fresh natural food and to need for the necessary packing and protective material. In the prescribing of any standard of quality for any canned fruit or canned vegetable, consideration shall be given and due allowance made for the differing characteristics of the several varieties of such fruit or vegetable. In prescribing a definition and standard of identity for any food or class of food in which optional ingredients are permitted, the Secretary shall, for the purpose of promoting honesty and fair dealing in the interest of consumers, designate the optional ingredients which shall be named on the label. Any definition and standard of identity prescribed by the Secretary for avocadoes, cantaloupes, citrus fruits, or melons shall relate only to maturity and to the effects of freezing.
(June 25, 1938, ch. 675, § 401, 52 Stat. 1046; Apr. 15, 1954, ch. 143, § 1, 68 Stat. 54; Aug. 1, 1956, ch. 861, § 1, 70 Stat. 919; Pub. L. 103–80, § 3(h), Aug. 13, 1993, 107 Stat. 776.)
§ 342. Adulterated foodA food shall be deemed to be adulterated—
(a) Poisonous, insanitary, etc., ingredients
(1) If it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health.1
1 So in original. The period probably should be “; or”.
(2)(A) if it bears or contains any added poisonous or added deleterious substance (other than a substance that is a pesticide chemical residue in or on a raw agricultural commodity or processed food, a food additive, a color additive, or a new animal drug) that is unsafe within the meaning of section 346 of this title; or (B) if it bears or contains a pesticide chemical residue that is unsafe within the meaning of section 346a(a) of this title; or (C) if it is or if it bears or contains (i) any food additive that is unsafe within the meaning of section 348 of this title; or (ii) a new animal drug (or conversion product thereof) that is unsafe within the meaning of section 360b of this title; or (3) if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food; or (4) if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health; or (5) if it is, in whole or in part, the product of a diseased animal or of an animal which has died otherwise than by slaughter; or (6) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or (7) if it has been intentionally subjected to radiation, unless the use of the radiation was in conformity with a regulation or exemption in effect pursuant to section 348 of this title.(b) Absence, substitution, or addition of constituents
(1) If any valuable constituent has been in whole or in part omitted or abstracted therefrom; or (2) if any substance has been substituted wholly or in part therefor; or (3) if damage or inferiority has been concealed in any manner; or (4) if any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is.
(c) Color additives
(d) Confectionery containing alcohol or nonnutritive substanceIf it is confectionery, and—
(1) has partially or completely imbedded therein any nonnutritive object, except that this subparagraph shall not apply in the case of any nonnutritive object if, in the judgment of the Secretary as provided by regulations, such object is of practical functional value to the confectionery product and would not render the product injurious or hazardous to health;
(2) bears or contains any alcohol other than alcohol not in excess of one-half of 1 per centum by volume derived solely from the use of flavoring extracts, except that this clause shall not apply to confectionery which is introduced or delivered for introduction into, or received or held for sale in, interstate commerce if the sale of such confectionery is permitted under the laws of the State in which such confectionery is intended to be offered for sale; or
(3) bears or contains any nonnutritive substance, except that this subparagraph shall not apply to a safe nonnutritive substance which is in or on confectionery by reason of its use for some practical functional purpose in the manufacture, packaging, or storage of such confectionery if the use of the substance does not promote deception of the consumer or otherwise result in adulteration or misbranding in violation of any provision of this chapter, except that the Secretary may, for the purpose of avoiding or resolving uncertainty as to the application of this subparagraph, issue regulations allowing or prohibiting the use of particular nonnutritive substances.
(e) Oleomargarine containing filthy, putrid, etc., matter
(f) Dietary supplement or ingredient: safety
(1) If it is a dietary supplement or contains a dietary ingredient that—
(A) presents a significant or unreasonable risk of illness or injury under—
(i) conditions of use recommended or suggested in labeling, or
(ii) if no conditions of use are suggested or recommended in the labeling, under ordinary conditions of use;
(B) is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury;
(C) the Secretary declares to pose an imminent hazard to public health or safety, except that the authority to make such declaration shall not be delegated and the Secretary shall promptly after such a declaration initiate a proceeding in accordance with sections 554 and 556 of title 5 to affirm or withdraw the declaration; or
(D) is or contains a dietary ingredient that renders it adulterated under paragraph (a)(1) under the conditions of use recommended or suggested in the labeling of such dietary supplement.
In any proceeding under this subparagraph, the United States shall bear the burden of proof on each element to show that a dietary supplement is adulterated. The court shall decide any issue under this paragraph on a de novo basis.
(2) Before the Secretary may report to a United States attorney a violation of paragraph 2
2 So in original. Probably should be “subparagraph”.
(1)(A) for a civil proceeding, the person against whom such proceeding would be initiated shall be given appropriate notice and the opportunity to present views, orally and in writing, at least 10 days before such notice, with regard to such proceeding.(g) Dietary supplement: manufacturing practices
(1) If it is a dietary supplement and it has been prepared, packed, or held under conditions that do not meet current good manufacturing practice regulations, including regulations requiring, when necessary, expiration date labeling, issued by the Secretary under subparagraph (2).
(2) The Secretary may by regulation prescribe good manufacturing practices for dietary supplements. Such regulations shall be modeled after current good manufacturing practice regulations for food and may not impose standards for which there is no current and generally available analytical methodology. No standard of current good manufacturing practice may be imposed unless such standard is included in a regulation promulgated after notice and opportunity for comment in accordance with chapter 5 of title 5.
(h) Reoffer of food previously denied admission
(i) Noncompliance with sanitary transportation practices
(June 25, 1938, ch. 675, § 402, 52 Stat. 1046; Mar. 16, 1950, ch. 61, § 3(d), 64 Stat. 21; July 22, 1954, ch. 559, § 2, 68 Stat. 511; July 9, 1956, ch. 530, 70 Stat. 512; Pub. L. 85–929, § 3(a), (b), Sept. 6, 1958, 72 Stat. 1784; Pub. L. 86–2, Mar. 17, 1959, 73 Stat. 3; Pub. L. 86–618, title I, §§ 102(a)(1), (2), 105(c), July 12, 1960, 74 Stat. 397, 398, 404; Pub. L. 89–477, June 29, 1966, 80 Stat. 231; Pub. L. 90–399, § 104, July 13, 1968, 82 Stat. 352; Pub. L. 99–252, § 10, Feb. 27, 1986, 100 Stat. 35; Pub. L. 102–571, title I, § 107(4), Oct. 29, 1992, 106 Stat. 4499; Pub. L. 103–80, § 3(i), Aug. 13, 1993, 107 Stat. 776; Pub. L. 103–417, §§ 4, 9, Oct. 25, 1994, 108 Stat. 4328, 4332; Pub. L. 104–170, title IV, § 404, Aug. 3, 1996, 110 Stat. 1514; Pub. L. 107–188, title III, § 309, June 12, 2002, 116 Stat. 673; Pub. L. 109–59, title VII, § 7202(a), Aug. 10, 2005, 119 Stat. 1911.)
§ 343. Misbranded foodA food shall be deemed to be misbranded—
(a) False or misleading label
(b) Offer for sale under another name
(c) Imitation of another food
(d) Misleading container
(e) Package form
(f) Prominence of information on label
(g) Representation as to definition and standard of identity
(h) Representation as to standards of quality and fill of containerIf it purports to be or is represented as—
(1) a food for which a standard of quality has been prescribed by regulations as provided by section 341 of this title, and its quality falls below such standard, unless its label bears, in such manner and form as such regulations specify, a statement that it falls below such standard;
(2) a food for which a standard or standards of fill of container have been prescribed by regulations as provided by section 341 of this title, and it falls below the standard of fill of container applicable thereto, unless its label bears, in such manner and form as such regulations specify, a statement that it falls below such standard; or
(3) a food that is pasteurized unless—
(A) such food has been subjected to a safe process or treatment that is prescribed as pasteurization for such food in a regulation promulgated under this chapter; or
(B)
(i) such food has been subjected to a safe process or treatment that—(I) is reasonably certain to achieve destruction or elimination in the food of the most resistant microorganisms of public health significance that are likely to occur in the food;(II) is at least as protective of the public health as a process or treatment described in subparagraph (A);(III) is effective for a period that is at least as long as the shelf life of the food when stored under normal and moderate abuse conditions; and(IV) is the subject of a notification to the Secretary, including effectiveness data regarding the process or treatment; and
(ii) at least 120 days have passed after the date of receipt of such notification by the Secretary without the Secretary making a determination that the process or treatment involved has not been shown to meet the requirements of subclauses (I) through (III) of clause (i).
For purposes of paragraph (3), a determination by the Secretary that a process or treatment has not been shown to meet the requirements of subclauses (I) through (III) of subparagraph (B)(i) shall constitute final agency action under such subclauses.
(i) Label where no representation as to definition and standard of identity
(j) Representation for special dietary use
(k) Artificial flavoring, artificial coloring, or chemical preservatives
(l) Pesticide chemicals on raw agricultural commodities
(m) Color additives
(n) Packaging or labeling of drugs in violation of regulations
(o) Repealed. Pub. L. 106–554, § 1(a)(1) [title V, § 517], Dec. 21, 2000, 114 Stat. 2763, 2763A–73
(p) Repealed. Pub. L. 104–124, § 1, Apr. 1, 1996, 110 Stat. 882
(q) Nutrition information
(1) Except as provided in subparagraphs (3), (4), and (5), if it is a food intended for human consumption and is offered for sale, unless its label or labeling bears nutrition information that provides—
(A)
(i) the serving size which is an amount customarily consumed and which is expressed in a common household measure that is appropriate to the food, or
(ii) if the use of the food is not typically expressed in a serving size, the common household unit of measure that expresses the serving size of the food,
(B) the number of servings or other units of measure per container,
(C) the total number of calories—
(i) derived from any source, and
(ii) derived from the total fat,
in each serving size or other unit of measure of the food,
(D) the amount of the following nutrients: Total fat, saturated fat, cholesterol, sodium, total carbohydrates, complex carbohydrates, sugars, dietary fiber, and total protein contained in each serving size or other unit of measure,
(E) any vitamin, mineral, or other nutrient required to be placed on the label and labeling of food under this chapter before October 1, 1990, if the Secretary determines that such information will assist consumers in maintaining healthy dietary practices.
The Secretary may by regulation require any information required to be placed on the label or labeling by this subparagraph or subparagraph (2)(A) to be highlighted on the label or labeling by larger type, bold type, or contrasting color if the Secretary determines that such highlighting will assist consumers in maintaining healthy dietary practices.
(2)
(A) If the Secretary determines that a nutrient other than a nutrient required by subparagraph (1)(C), (1)(D), or (1)(E) should be included in the label or labeling of food subject to subparagraph (1) for purposes of providing information regarding the nutritional value of such food that will assist consumers in maintaining healthy dietary practices, the Secretary may by regulation require that information relating to such additional nutrient be included in the label or labeling of such food.
(B) If the Secretary determines that the information relating to a nutrient required by subparagraph (1)(C), (1)(D), or (1)(E) or clause (A) of this subparagraph to be included in the label or labeling of food is not necessary to assist consumers in maintaining healthy dietary practices, the Secretary may by regulation remove information relating to such nutrient from such requirement.
(3) For food that is received in bulk containers at a retail establishment, the Secretary may, by regulation, provide that the nutrition information required by subparagraphs (1) and (2) be displayed at the location in the retail establishment at which the food is offered for sale.
(4)
(A) The Secretary shall provide for furnishing the nutrition information required by subparagraphs (1) and (2) with respect to raw agricultural commodities and raw fish by issuing voluntary nutrition guidelines, as provided by clause (B) or by issuing regulations that are mandatory as provided by clause (D).
(B)
(i) Upon the expiration of 12 months after November 8, 1990, the Secretary, after providing an opportunity for comment, shall issue guidelines for food retailers offering raw agricultural commodities or raw fish to provide nutrition information specified in subparagraphs (1) and (2). Such guidelines shall take into account the actions taken by food retailers during such 12-month period to provide to consumers nutrition information on raw agricultural commodities and raw fish. Such guidelines shall only apply—(I) in the case of raw agricultural commodities, to the 20 varieties of vegetables most frequently consumed during a year and the 20 varieties of fruit most frequently consumed during a year, and(II) to the 20 varieties of raw fish most frequently consumed during a year.
The vegetables, fruits, and raw fish to which such guidelines apply shall be determined by the Secretary by regulation and the Secretary may apply such guidelines regionally.
(ii) Upon the expiration of 12 months after November 8, 1990, the Secretary shall issue a final regulation defining the circumstances that constitute substantial compliance by food retailers with the guidelines issued under subclause (i). The regulation shall provide that there is not substantial compliance if a significant number of retailers have failed to comply with the guidelines. The size of the retailers and the portion of the market served by retailers in compliance with the guidelines shall be considered in determining whether the substantial-compliance standard has been met.
(C)
(i) Upon the expiration of 30 months after November 8, 1990, the Secretary shall issue a report on actions taken by food retailers to provide consumers with nutrition information for raw agricultural commodities and raw fish under the guidelines issued under clause (A). Such report shall include a determination of whether there is substantial compliance with the guidelines.
(ii) If the Secretary finds that there is substantial compliance with the guidelines, the Secretary shall issue a report and make a determination of the type required in subclause (i) every two years.
(D)
(i) If the Secretary determines that there is not substantial compliance with the guidelines issued under clause (A), the Secretary shall at the time such determination is made issue proposed regulations requiring that any person who offers raw agricultural commodities or raw fish to consumers provide, in a manner prescribed by regulations, the nutrition information required by subparagraphs (1) and (2). The Secretary shall issue final regulations imposing such requirements 6 months after issuing the proposed regulations. The final regulations shall become effective 6 months after the date of their promulgation.
(ii) Regulations issued under subclause (i) may require that the nutrition information required by subparagraphs (1) and (2) be provided for more than 20 varieties of vegetables, 20 varieties of fruit, and 20 varieties of fish most frequently consumed during a year if the Secretary finds that a larger number of such products are frequently consumed. Such regulations shall permit such information to be provided in a single location in each area in which raw agricultural commodities and raw fish are offered for sale. Such regulations may provide that information shall be expressed as an average or range per serving of the same type of raw agricultural commodity or raw fish. The Secretary shall develop and make available to the persons who offer such food to consumers the information required by subparagraphs (1) and (2).
(iii) Regulations issued under subclause (i) shall permit the required information to be provided in each area of an establishment in which raw agricultural commodities and raw fish are offered for sale. The regulations shall permit food retailers to display the required information by supplying copies of the information provided by the Secretary, by making the information available in brochure, notebook or leaflet form, or by posting a sign disclosing the information. Such regulations shall also permit presentation of the required information to be supplemented by a video, live demonstration, or other media which the Secretary approves.
(E) For purposes of this subparagraph, the term “fish” includes freshwater or marine fin fish, crustaceans, and mollusks, including shellfish, amphibians, and other forms of aquatic animal life.
(F) No person who offers raw agricultural commodities or raw fish to consumers may be prosecuted for minor violations of this subparagraph if there has been substantial compliance with the requirements of this paragraph.
(5)
(A) Subparagraphs (1), (2), (3), and (4) shall not apply to food—
(i) except as provided in clause (H)(ii)(III), which is served in restaurants or other establishments in which food is served for immediate human consumption or which is sold for sale or use in such establishments,
(ii) except as provided in clause (H)(ii)(III), which is processed and prepared primarily in a retail establishment, which is ready for human consumption, which is of the type described in subclause (i), and which is offered for sale to consumers but not for immediate human consumption in such establishment and which is not offered for sale outside such establishment,
(iii) which is an infant formula subject to section 350a of this title,
(iv) which is a medical food as defined in section 360ee(b) of this title, or
(v) which is described in section 345(2) of this title.
(B) Subparagraphs (1) and (2) shall not apply to the label of a food if the Secretary determines by regulations that compliance with such subparagraphs is impracticable because the package of such food is too small to comply with the requirements of such subparagraphs and if the label of such food does not contain any nutrition information.
(C) If a food contains insignificant amounts, as determined by the Secretary, of all the nutrients required by subparagraphs (1) and (2) to be listed in the label or labeling of food, the requirements of such subparagraphs shall not apply to such food if the label, labeling, or advertising of such food does not make any claim with respect to the nutritional value of such food. If a food contains insignificant amounts, as determined by the Secretary, of more than one-half the nutrients required by subparagraphs (1) and (2) to be in the label or labeling of the food, the Secretary shall require the amounts of such nutrients to be stated in a simplified form prescribed by the Secretary.
(D) If a person offers food for sale and has annual gross sales made or business done in sales to consumers which is not more than $500,000 or has annual gross sales made or business done in sales of food to consumers which is not more than $50,000, the requirements of subparagraphs (1), (2), (3), and (4) shall not apply with respect to food sold by such person to consumers unless the label or labeling of food offered by such person provides nutrition information or makes a nutrition claim.
(E)
(i) During the 12-month period for which an exemption from subparagraphs (1) and (2) is claimed pursuant to this subclause, the requirements of such subparagraphs shall not apply to any food product if—(I) the labeling for such product does not provide nutrition information or make a claim subject to paragraph (r),(II) the person who claims for such product an exemption from such subparagraphs employed fewer than an average of 100 full-time equivalent employees,(III) such person provided the notice described in subclause (iii), and(IV) in the case of a food product which was sold in the 12-month period preceding the period for which an exemption was claimed, fewer than 100,000 units of such product were sold in the United States during such preceding period, or in the case of a food product which was not sold in the 12-month period preceding the period for which such exemption is claimed, fewer than 100,000 units of such product are reasonably anticipated to be sold in the United States during the period for which such exemption is claimed.
(ii) During the 12-month period after the applicable date referred to in this sentence, the requirements of subparagraphs (1) and (2) shall not apply to any food product which was first introduced into interstate commerce before May 8, 1994, if the labeling for such product does not provide nutrition information or make a claim subject to paragraph (r), if such person provided the notice described in subclause (iii), and if—(I) during the 12-month period preceding May 8, 1994, the person who claims for such product an exemption from such subparagraphs employed fewer than an average of 300 full-time equivalent employees and fewer than 600,000 units of such product were sold in the United States,(II) during the 12-month period preceding May 8, 1995, the person who claims for such product an exemption from such subparagraphs employed fewer than an average of 300 full-time equivalent employees and fewer than 400,000 units of such product were sold in the United States, or(III) during the 12-month period preceding May 8, 1996, the person who claims for such product an exemption from such subparagraphs employed fewer than an average of 200 full-time equivalent employees and fewer than 200,000 units of such product were sold in the United States.
(iii) The notice referred to in subclauses (i) and (ii) shall be given to the Secretary prior to the beginning of the period during which the exemption under subclause (i) or (ii) is to be in effect, shall state that the person claiming such exemption for a food product has complied with the applicable requirements of subclause (i) or (ii), and shall—(I) state the average number of full-time equivalent employees such person employed during the 12 months preceding the date such person claims such exemption,(II) state the approximate number of units the person claiming the exemption sold in the United States,(III) if the exemption is claimed for a food product which was sold in the 12-month period preceding the period for which the exemption was claimed, state the approximate number of units of such product which were sold in the United States during such preceding period, and, if the exemption is claimed for a food product which was not sold in such preceding period, state the number of units of such product which such person reasonably anticipates will be sold in the United States during the period for which the exemption was claimed, and(IV) contain such information as the Secretary may require to verify the information required by the preceding provisions of this subclause if the Secretary has questioned the validity of such information.
If a person is not an importer, has fewer than 10 full-time equivalent employees, and sells fewer than 10,000 units of any food product in any year, such person is not required to file a notice for such product under this subclause for such year.
(iv) In the case of a person who claimed an exemption under subclause (i) or (ii), if, during the period of such exemption, the number of full-time equivalent employees of such person exceeds the number in such subclause or if the number of food products sold in the United States exceeds the number in such subclause, such exemption shall extend to the expiration of 18 months after the date the number of full-time equivalent employees or food products sold exceeded the applicable number.
(v) For any food product first introduced into interstate commerce after May 8, 2002, the Secretary may by regulation lower the employee or units of food products requirement of subclause (i) if the Secretary determines that the cost of compliance with such lower requirement will not place an undue burden on persons subject to such lower requirement.
(vi) For purposes of subclauses (i), (ii), (iii), (iv), and (v)—(I) the term “unit” means the packaging or, if there is no packaging, the form in which a food product is offered for sale to consumers,(II) the term “food product” means food in any sized package which is manufactured by a single manufacturer or which bears the same brand name, which bears the same statement of identity, and which has similar preparation methods, and(III) the term “person” in the case of a corporation includes all domestic and foreign affiliates of the corporation.
(F) A dietary supplement product (including a food to which section 350 of this title applies) shall comply with the requirements of subparagraphs (1) and (2) in a manner which is appropriate for the product and which is specified in regulations of the Secretary which shall provide that—
(i) nutrition information shall first list those dietary ingredients that are present in the product in a significant amount and for which a recommendation for daily consumption has been established by the Secretary, except that a dietary ingredient shall not be required to be listed if it is not present in a significant amount, and shall list any other dietary ingredient present and identified as having no such recommendation;
(ii) the listing of dietary ingredients shall include the quantity of each such ingredient (or of a proprietary blend of such ingredients) per serving;
(iii) the listing of dietary ingredients may include the source of a dietary ingredient; and
(iv) the nutrition information shall immediately precede the ingredient information required under subclause (i), except that no ingredient identified pursuant to subclause (i) shall be required to be identified a second time.
(G) Subparagraphs (1), (2), (3), and (4) shall not apply to food which is sold by a food distributor if the food distributor principally sells food to restaurants or other establishments in which food is served for immediate human consumption and does not manufacture, process, or repackage the food it sells.
(H)Restaurants, Retail Food Establishments, and Vending Machines.—
(i)General requirements for restaurants and similar retail food establishments.—Except for food described in subclause (vii), in the case of food that is a standard menu item that is offered for sale in a restaurant or similar retail food establishment that is part of a chain with 20 or more locations doing business under the same name (regardless of the type of ownership of the locations) and offering for sale substantially the same menu items, the restaurant or similar retail food establishment shall disclose the information described in subclauses (ii) and (iii).
(ii)Information required to be disclosed by restaurants and retail food establishments.—Except as provided in subclause (vii), the restaurant or similar retail food establishment shall disclose in a clear and conspicuous manner—(I)(aa) in a nutrient span disclosure statement adjacent to the name of the standard menu item, so as to be clearly associated with the standard menu item, on the menu listing the item for sale, the number of calories contained in the standard menu item, as usually prepared and offered for sale; and(bb) a succinct statement concerning suggested daily caloric intake, as specified by the Secretary by regulation and posted prominently on the menu and designed to enable the public to understand, in the context of a total daily diet, the significance of the caloric information that is provided on the menu;(II)(aa) in a nutrient span disclosure statement adjacent to the name of the standard menu item, so as to be clearly associated with the standard menu item, on the menu board, including a drive-through menu board, the number of calories contained in the standard menu item, as usually prepared and offered for sale; and(bb) a succinct statement concerning suggested daily caloric intake, as specified by the Secretary by regulation and posted prominently on the menu board, designed to enable the public to understand, in the context of a total daily diet, the significance of the nutrition information that is provided on the menu board;(III) in a written form, available on the premises of the restaurant or similar retail establishment and to the consumer upon request, the nutrition information required under clauses (C) and (D) of subparagraph (1); and(IV) on the menu or menu board, a prominent, clear, and conspicuous statement regarding the availability of the information described in item (III).
(iii)Self-service food and food on display.—Except as provided in subclause (vii), in the case of food sold at a salad bar, buffet line, cafeteria line, or similar self-service facility, and for self-service beverages or food that is on display and that is visible to customers, a restaurant or similar retail food establishment shall place adjacent to each food offered a sign that lists calories per displayed food item or per serving.
(iv)Reasonable basis.—For the purposes of this clause, a restaurant or similar retail food establishment shall have a reasonable basis for its nutrient span disclosures, including nutrient databases, cookbooks, laboratory analyses, and other reasonable means, as described in section 101.10 of title 21, Code of Federal Regulations (or any successor regulation) or in a related guidance of the Food and Drug Administration.
(v)Menu variability and combination meals.—The Secretary shall establish by regulation standards for determining and disclosing the nutrient span for standard menu items that come in different flavors, varieties, or combinations, but which are listed as a single menu item, such as soft drinks, ice cream, pizza, doughnuts, or children’s combination meals, through means determined by the Secretary, including ranges, averages, or other methods.
(vi)Additional information.—If the Secretary determines that a nutrient, other than a nutrient required under subclause (ii)(III), should be disclosed for the purpose of providing information to assist consumers in maintaining healthy dietary practices, the Secretary may require, by regulation, disclosure of such nutrient in the written form required under subclause (ii)(III).
(vii)Nonapplicability to certain food.—(I)In general.—Subclauses (i) through (vi) do not apply to—(aa) items that are not listed on a menu or menu board (such as condiments and other items placed on the table or counter for general use);(bb) daily specials, temporary menu items appearing on the menu for less than 60 days per calendar year, or custom orders; or(cc) such other food that is part of a customary market test appearing on the menu for less than 90 days, under terms and conditions established by the Secretary.(II)Written forms.—Subparagraph (5)(C) shall apply to any regulations promulgated under subclauses (ii)(III) and (vi).
(viii)Vending machines.—(I)In general.—In the case of an article of food sold from a vending machine that—(aa) does not permit a prospective purchaser to examine the Nutrition Facts Panel before purchasing the article or does not otherwise provide visible nutrition information at the point of purchase; and(bb) is operated by a person who is engaged in the business of owning or operating 20 or more vending machines,
the vending machine operator shall provide a sign in close proximity to each article of food or the selection button that includes a clear and conspicuous statement disclosing the number of calories contained in the article.
(ix)Voluntary provision of nutrition information.—(I)In general.—An authorized official of any restaurant or similar retail food establishment or vending machine operator not subject to the requirements of this clause may elect to be subject to the requirements of such clause, by registering biannually the name and address of such restaurant or similar retail food establishment or vending machine operator with the Secretary, as specified by the Secretary by regulation.(II)Registration.—Within 120 days of March 23, 2010, the Secretary shall publish a notice in the Federal Register specifying the terms and conditions for implementation of item (I), pending promulgation of regulations.(III)Rule of construction.—Nothing in this subclause shall be construed to authorize the Secretary to require an application, review, or licensing process for any entity to register with the Secretary, as described in such item.
(x)Regulations.—(I)Proposed regulation.—Not later than 1 year after March 23, 2010, the Secretary shall promulgate proposed regulations to carry out this clause.(II)Contents.—In promulgating regulations, the Secretary shall—(aa) consider standardization of recipes and methods of preparation, reasonable variation in serving size and formulation of menu items, space on menus and menu boards, inadvertent human error, training of food service workers, variations in ingredients, and other factors, as the Secretary determines; and(bb) specify the format and manner of the nutrient span disclosure requirements under this subclause.(III)Reporting.—The Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a quarterly report that describes the Secretary’s progress toward promulgating final regulations under this subparagraph.
(xi)Definition.—In this clause, the term “menu” or “menu board” means the primary writing of the restaurant or other similar retail food establishment from which a consumer makes an order selection.
(r) Nutrition levels and health-related claims
(1) Except as provided in clauses (A) through (C) of subparagraph (5), if it is a food intended for human consumption which is offered for sale and for which a claim is made in the label or labeling of the food which expressly or by implication—
(A) characterizes the level of any nutrient which is of the type required by paragraph (q)(1) or (q)(2) to be in the label or labeling of the food unless the claim is made in accordance with subparagraph (2), or
(B) characterizes the relationship of any nutrient which is of the type required by paragraph (q)(1) or (q)(2) to be in the label or labeling of the food to a disease or a health-related condition unless the claim is made in accordance with subparagraph (3) or (5)(D).
A statement of the type required by paragraph (q) that appears as part of the nutrition information required or permitted by such paragraph is not a claim which is subject to this paragraph and a claim subject to clause (A) is not subject to clause (B).
(2)
(A) Except as provided in subparagraphs (4)(A)(ii) and (4)(A)(iii) and clauses (A) through (C) of subparagraph (5), a claim described in subparagraph (1)(A)—
(i) may be made only if the characterization of the level made in the claim uses terms which are defined in regulations of the Secretary,
(ii) may not state the absence of a nutrient unless—(I) the nutrient is usually present in the food or in a food which substitutes for the food as defined by the Secretary by regulation, or(II) the Secretary by regulation permits such a statement on the basis of a finding that such a statement would assist consumers in maintaining healthy dietary practices and the statement discloses that the nutrient is not usually present in the food,
(iii) may not be made with respect to the level of cholesterol in the food if the food contains, as determined by the Secretary by regulation, fat or saturated fat in an amount which increases to persons in the general population the risk of disease or a health related condition which is diet related unless—(I) the Secretary finds by regulation that the level of cholesterol is substantially less than the level usually present in the food or in a food which substitutes for the food and which has a significant market share, or the Secretary by regulation permits a statement regarding the absence of cholesterol on the basis of a finding that cholesterol is not usually present in the food and that such a statement would assist consumers in maintaining healthy dietary practices and the regulation requires that the statement disclose that cholesterol is not usually present in the food, and(II) the label or labeling of the food discloses the level of such fat or saturated fat in immediate proximity to such claim and with appropriate prominence which shall be no less than one-half the size of the claim with respect to the level of cholesterol,
(iv) may not be made with respect to the level of saturated fat in the food if the food contains cholesterol unless the label or labeling of the food discloses the level of cholesterol in the food in immediate proximity to such claim and with appropriate prominence which shall be no less than one-half the size of the claim with respect to the level of saturated fat,
(v) may not state that a food is high in dietary fiber unless the food is low in total fat as defined by the Secretary or the label or labeling discloses the level of total fat in the food in immediate proximity to such statement and with appropriate prominence which shall be no less than one-half the size of the claim with respect to the level of dietary fiber, and
(vi) may not be made if the Secretary by regulation prohibits the claim because the claim is misleading in light of the level of another nutrient in the food.
(B) If a claim described in subparagraph (1)(A) is made with respect to a nutrient in a food and the Secretary makes a determination that the food contains a nutrient at a level that increases to persons in the general population the risk of a disease or health-related condition that is diet related, the label or labeling of such food shall contain, prominently and in immediate proximity to such claim, the following statement: “See nutrition information for ___ span.” The blank shall identify the nutrient associated with the increased disease or health-related condition risk. In making the determination described in this clause, the Secretary shall take into account the significance of the food in the total daily diet.
(C) Subparagraph (2)(A) does not apply to a claim described in subparagraph (1)(A) and contained in the label or labeling of a food if such claim is contained in the brand name of such food and such brand name was in use on such food before October 25, 1989, unless the brand name contains a term defined by the Secretary under subparagraph (2)(A)(i). Such a claim is subject to paragraph (a).
(D) Subparagraph (2) does not apply to a claim described in subparagraph (1)(A) which uses the term “diet” and is contained in the label or labeling of a soft drink if (i) such claim is contained in the brand name of such soft drink, (ii) such brand name was in use on such soft drink before October 25, 1989, and (iii) the use of the term “diet” was in conformity with section 105.66 of title 21 of the Code of Federal Regulations. Such a claim is subject to paragraph (a).
(E) Subclauses (i) through (v) of subparagraph (2)(A) do not apply to a statement in the label or labeling of food which describes the percentage of vitamins and minerals in the food in relation to the amount of such vitamins and minerals recommended for daily consumption by the Secretary.
(F) Subclause (i) clause (A) does not apply to a statement in the labeling of a dietary supplement that characterizes the percentage level of a dietary ingredient for which the Secretary has not established a reference daily intake, daily recommended value, or other recommendation for daily consumption.
(G) A claim of the type described in subparagraph (1)(A) for a nutrient, for which the Secretary has not promulgated a regulation under clause (A)(i), shall be authorized and may be made with respect to a food if—
(i) a scientific body of the United States Government with official responsibility for public health protection or research directly relating to human nutrition (such as the National Institutes of Health or the Centers for Disease Control and Prevention) or the National Academy of Sciences or any of its subdivisions has published an authoritative statement, which is currently in effect, which identifies the nutrient level to which the claim refers;
(ii) a person has submitted to the Secretary, at least 120 days (during which the Secretary may notify any person who is making a claim as authorized by clause (C) that such person has not submitted all the information required by such clause) before the first introduction into interstate commerce of the food with a label containing the claim, (I) a notice of the claim, which shall include the exact words used in the claim and shall include a concise description of the basis upon which such person relied for determining that the requirements of subclause (i) have been satisfied, (II) a copy of the statement referred to in subclause (i) upon which such person relied in making the claim, and (III) a balanced representation of the scientific literature relating to the nutrient level to which the claim refers;
(iii) the claim and the food for which the claim is made are in compliance with clauses (A) and (B), and are otherwise in compliance with paragraph (a) and section 321(n) of this title; and
(iv) the claim is stated in a manner so that the claim is an accurate representation of the authoritative statement referred to in subclause (i) and so that the claim enables the public to comprehend the information provided in the claim and to understand the relative significance of such information in the context of a total daily diet.
For purposes of this clause, a statement shall be regarded as an authoritative statement of a scientific body described in subclause (i) only if the statement is published by the scientific body and shall not include a statement of an employee of the scientific body made in the individual capacity of the employee.
(H) A claim submitted under the requirements of clause (G) may be made until—
(i) such time as the Secretary issues a regulation—(I) prohibiting or modifying the claim and the regulation has become effective, or(II) finding that the requirements of clause (G) have not been met, including finding that the petitioner had not submitted all the information required by such clause; or
(ii) a district court of the United States in an enforcement proceeding under subchapter III has determined that the requirements of clause (G) have not been met.
(3)
(A) Except as provided in subparagraph (5), a claim described in subparagraph (1)(B) may only be made—
(i) if the claim meets the requirements of the regulations of the Secretary promulgated under clause (B), and
(ii) if the food for which the claim is made does not contain, as determined by the Secretary by regulation, any nutrient in an amount which increases to persons in the general population the risk of a disease or health-related condition which is diet related, taking into account the significance of the food in the total daily diet, except that the Secretary may by regulation permit such a claim based on a finding that such a claim would assist consumers in maintaining healthy dietary practices and based on a requirement that the label contain a disclosure of the type required by subparagraph (2)(B).
(B)
(i) The Secretary shall promulgate regulations authorizing claims of the type described in subparagraph (1)(B) only if the Secretary determines, based on the totality of publicly available scientific evidence (including evidence from well-designed studies conducted in a manner which is consistent with generally recognized scientific procedures and principles), that there is significant scientific agreement, among experts qualified by scientific training and experience to evaluate such claims, that the claim is supported by such evidence.
(ii) A regulation described in subclause (i) shall describe—(I) the relationship between a nutrient of the type required in the label or labeling of food by paragraph (q)(1) or (q)(2) and a disease or health-related condition, and(II) the significance of each such nutrient in affecting such disease or health-related condition.
(iii) A regulation described in subclause (i) shall require such claim to be stated in a manner so that the claim is an accurate representation of the matters set out in subclause (ii) and so that the claim enables the public to comprehend the information provided in the claim and to understand the relative significance of such information in the context of a total daily diet.
(C) Notwithstanding the provisions of clauses (A)(i) and (B), a claim of the type described in subparagraph (1)(B) which is not authorized by the Secretary in a regulation promulgated in accordance with clause (B) shall be authorized and may be made with respect to a food if—
(i) a scientific body of the United States Government with official responsibility for public health protection or research directly relating to human nutrition (such as the National Institutes of Health or the Centers for Disease Control and Prevention) or the National Academy of Sciences or any of its subdivisions has published an authoritative statement, which is currently in effect, about the relationship between a nutrient and a disease or health-related condition to which the claim refers;
(ii) a person has submitted to the Secretary, at least 120 days (during which the Secretary may notify any person who is making a claim as authorized by clause (C) that such person has not submitted all the information required by such clause) before the first introduction into interstate commerce of the food with a label containing the claim, (I) a notice of the claim, which shall include the exact words used in the claim and shall include a concise description of the basis upon which such person relied for determining that the requirements of subclause (i) have been satisfied, (II) a copy of the statement referred to in subclause (i) upon which such person relied in making the claim, and (III) a balanced representation of the scientific literature relating to the relationship between a nutrient and a disease or health-related condition to which the claim refers;
(iii) the claim and the food for which the claim is made are in compliance with clause (A)(ii) and are otherwise in compliance with paragraph (a) and section 321(n) of this title; and
(iv) the claim is stated in a manner so that the claim is an accurate representation of the authoritative statement referred to in subclause (i) and so that the claim enables the public to comprehend the information provided in the claim and to understand the relative significance of such information in the context of a total daily diet.
For purposes of this clause, a statement shall be regarded as an authoritative statement of a scientific body described in subclause (i) only if the statement is published by the scientific body and shall not include a statement of an employee of the scientific body made in the individual capacity of the employee.
(D) A claim submitted under the requirements of clause (C) may be made until—
(i) such time as the Secretary issues a regulation under the standard in clause (B)(i)—(I) prohibiting or modifying the claim and the regulation has become effective, or(II) finding that the requirements of clause (C) have not been met, including finding that the petitioner has not submitted all the information required by such clause; or
(ii) a district court of the United States in an enforcement proceeding under subchapter III has determined that the requirements of clause (C) have not been met.
(4)
(A)
(i) Any person may petition the Secretary to issue a regulation under subparagraph (2)(A)(i) or (3)(B) relating to a claim described in subparagraph (1)(A) or (1)(B). Not later than 100 days after the petition is received by the Secretary, the Secretary shall issue a final decision denying the petition or file the petition for further action by the Secretary. If the Secretary does not act within such 100 days, the petition shall be deemed to be denied unless an extension is mutually agreed upon by the Secretary and the petitioner. If the Secretary denies the petition or the petition is deemed to be denied, the petition shall not be made available to the public. If the Secretary files the petition, the Secretary shall deny the petition or issue a proposed regulation to take the action requested in the petition not later than 90 days after the date of such decision. If the Secretary does not act within such 90 days, the petition shall be deemed to be denied unless an extension is mutually agreed upon by the Secretary and the petitioner. If the Secretary issues a proposed regulation, the rulemaking shall be completed within 540 days of the date the petition is received by the Secretary. If the Secretary does not issue a regulation within such 540 days, the Secretary shall provide the Committee on Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate the reasons action on the regulation did not occur within such 540 days.
(ii) Any person may petition the Secretary for permission to use in a claim described in subparagraph (1)(A) terms that are consistent with the terms defined by the Secretary under subparagraph (2)(A)(i). Within 90 days of the submission of such a petition, the Secretary shall issue a final decision denying the petition or granting such permission.
(iii) Any person may petition the Secretary for permission to use an implied claim described in subparagraph (1)(A) in a brand name. After publishing notice of an opportunity to comment on the petition in the Federal Register and making the petition available to the public, the Secretary shall grant the petition if the Secretary finds that such claim is not misleading and is consistent with terms defined by the Secretary under subparagraph (2)(A)(i). The Secretary shall grant or deny the petition within 100 days of the date it is submitted to the Secretary and the petition shall be considered granted if the Secretary does not act on it within such 100 days.
(B) A petition under clause (A)(i) respecting a claim described in subparagraph (1)(A) or (1)(B) shall include an explanation of the reasons why the claim meets the requirements of this paragraph and a summary of the scientific data which supports such reasons.
(C) If a petition for a regulation under subparagraph (3)(B) relies on a report from an authoritative scientific body of the United States, the Secretary shall consider such report and shall justify any decision rejecting the conclusions of such report.
(5)
(A) This paragraph does not apply to infant formulas subject to section 350a(h) of this title and medical foods as defined in section 360ee(b) of this title.
(B) Subclauses (iii) through (v) of subparagraph (2)(A) and subparagraph (2)(B) do not apply to food which is served in restaurants or other establishments in which food is served for immediate human consumption or which is sold for sale or use in such establishments.
(C) A subparagraph (1)(A) claim made with respect to a food which claim is required by a standard of identity issued under section 341 of this title shall not be subject to subparagraph (2)(A)(i) or (2)(B).
(D) A subparagraph (1)(B) claim made with respect to a dietary supplement of vitamins, minerals, herbs, or other similar nutritional substances shall not be subject to subparagraph (3) but shall be subject to a procedure and standard, respecting the validity of such claim, established by regulation of the Secretary.
(6) For purposes of paragraph (r)(1)(B), a statement for a dietary supplement may be made if—
(A) the statement claims a benefit related to a classical nutrient deficiency disease and discloses the prevalence of such disease in the United States, describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans, characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function, or describes general well-being from consumption of a nutrient or dietary ingredient,
(B) the manufacturer of the dietary supplement has substantiation that such statement is truthful and not misleading, and
(C) the statement contains, prominently displayed and in boldface type, the following: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”.
A statement under this subparagraph may not claim to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases. If the manufacturer of a dietary supplement proposes to make a statement described in the first sentence of this subparagraph in the labeling of the dietary supplement, the manufacturer shall notify the Secretary no later than 30 days after the first marketing of the dietary supplement with such statement that such a statement is being made.
(7) The Secretary may make proposed regulations issued under this paragraph effective upon publication pending consideration of public comment and publication of a final regulation if the Secretary determines that such action is necessary—
(A) to enable the Secretary to review and act promptly on petitions the Secretary determines provide for information necessary to—
(i) enable consumers to develop and maintain healthy dietary practices;
(ii) enable consumers to be informed promptly and effectively of important new knowledge regarding nutritional and health benefits of food; or
(iii) ensure that scientifically sound nutritional and health information is provided to consumers as soon as possible; or
(B) to enable the Secretary to act promptly to ban or modify a claim under this paragraph.
Such proposed regulations shall be deemed final agency action for purposes of judicial review.
(s) Dietary supplementsIf—
(1) it is a dietary supplement; and
(2)
(A) the label or labeling of the supplement fails to list—
(i) the name of each ingredient of the supplement that is described in section 321(ff) of this title; and
(ii)(I) the quantity of each such ingredient; or(II) with respect to a proprietary blend of such ingredients, the total quantity of all ingredients in the blend;
(B) the label or labeling of the dietary supplement fails to identify the product by using the term “dietary supplement”, which term may be modified with the name of such an ingredient;
(C) the supplement contains an ingredient described in section 321(ff)(1)(C) of this title, and the label or labeling of the supplement fails to identify any part of the plant from which the ingredient is derived;
(D) the supplement—
(i) is covered by the specifications of an official compendium;
(ii) is represented as conforming to the specifications of an official compendium; and
(iii) fails to so conform; or
(E) the supplement—
(i) is not covered by the specifications of an official compendium; and
(ii)(I) fails to have the identity and strength that the supplement is represented to have; or(II) fails to meet the quality (including tablet or capsule disintegration), purity, or compositional specifications, based on validated assay or other appropriate methods, that the supplement is represented to meet.
A dietary supplement shall not be deemed misbranded solely because its label or labeling contains directions or conditions of use or warnings.
(t) Catfish
(u) Ginseng
(v) Failure to label; health threat If—
(1) it fails to bear a label required by the Secretary under section 381(n)(1) of this title (relating to food refused admission into the United States);
(2) the Secretary finds that the food presents a threat of serious adverse health consequences or death to humans or animals; and
(3) upon or after notifying the owner or consignee involved that the label is required under section 381 of this title, the Secretary informs the owner or consignee that the food presents such a threat.
(w) Major food allergen labeling requirements
(1) If it is not a raw agricultural commodity and it is, or it contains an ingredient that bears or contains, a major food allergen, unless either—
(A) the word “Contains”, followed by the name of the food source from which the major food allergen is derived, is printed immediately after or is adjacent to the list of ingredients (in a type size no smaller than the type size used in the list of ingredients) required under subsections (g) and (i); or
(B) the common or usual name of the major food allergen in the list of ingredients required under subsections (g) and (i) is followed in parentheses by the name of the food source from which the major food allergen is derived, except that the name of the food source is not required when—
(i) the common or usual name of the ingredient uses the name of the food source from which the major food allergen is derived; or
(ii) the name of the food source from which the major food allergen is derived appears elsewhere in the ingredient list, unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of a food ingredient that is not a major food allergen under section 321(qq)(2)(A) or (B) of this title.
(2) As used in this subsection, the term “name of the food source from which the major food allergen is derived” means the name described in section 321(qq)(1) of this title; provided that in the case of a tree nut, fish, or Crustacean shellfish, the term “name of the food source from which the major food allergen is derived” means the name of the specific type of nut or species of fish or Crustacean shellfish.
(3) The information required under this subsection may appear in labeling in lieu of appearing on the label only if the Secretary finds that such other labeling is sufficient to protect the public health. A finding by the Secretary under this paragraph (including any change in an earlier finding under this paragraph) is effective upon publication in the Federal Register as a notice.
(4) Notwithstanding subsection (g), (i), or (k), or any other law, a flavoring, coloring, or incidental additive that is, or that bears or contains, a major food allergen shall be subject to the labeling requirements of this subsection.
(5) The Secretary may by regulation modify the requirements of subparagraph (A) or (B) of paragraph (1), or eliminate either the requirement of subparagraph (A) or the requirements of subparagraph (B) of paragraph (1), if the Secretary determines that the modification or elimination of the requirement of subparagraph (A) or the requirements of subparagraph (B) is necessary to protect the public health.
(6)
(A) Any person may petition the Secretary to exempt a food ingredient described in section 321(qq)(2) of this title from the allergen labeling requirements of this subsection.
(B) The Secretary shall approve or deny such petition within 180 days of receipt of the petition or the petition shall be deemed denied, unless an extension of time is mutually agreed upon by the Secretary and the petitioner.
(C) The burden shall be on the petitioner to provide scientific evidence (including the analytical method used to produce the evidence) that demonstrates that such food ingredient, as derived by the method specified in the petition, does not cause an allergic response that poses a risk to human health.
(D) A determination regarding a petition under this paragraph shall constitute final agency action.
(E) The Secretary shall promptly post to a public site all petitions received under this paragraph within 14 days of receipt and the Secretary shall promptly post the Secretary’s response to each.
(7)
(A) A person need not file a petition under paragraph (6) to exempt a food ingredient described in section 321(qq)(2) of this title from the allergen labeling requirements of this subsection, if the person files with the Secretary a notification containing—
(i) scientific evidence (including the analytical method used) that demonstrates that the food ingredient (as derived by the method specified in the notification, where applicable) does not contain allergenic protein; or
(ii) a determination by the Secretary that the ingredient does not cause an allergic response that poses a risk to human health under a premarket approval or notification program under section 348 of this title.
(B) The food ingredient may be introduced or delivered for introduction into interstate commerce as a food ingredient that is not a major food allergen 90 days after the date of receipt of the notification by the Secretary, unless the Secretary determines within the 90-day period that the notification does not meet the requirements of this paragraph, or there is insufficient scientific evidence to determine that the food ingredient does not contain allergenic protein or does not cause an allergenic response that poses a risk to human health.
(C) The Secretary shall promptly post to a public site all notifications received under this subparagraph within 14 days of receipt and promptly post any objections thereto by the Secretary.
(x) Nonmajor food allergen labeling requirements
(y) Dietary supplements
(June 25, 1938, ch. 675, § 403, 52 Stat. 1047; Pub. L. 86–537, § 1, June 29, 1960, 74 Stat. 251; Pub. L. 86–618, title I, § 102(a)(3), July 12, 1960, 74 Stat. 398; Pub. L. 91–601, § 6(c), formerly § 7(c), Dec. 30, 1970, 84 Stat. 1673, renumbered Pub. L. 97–35, title XII, § 1205(c), Aug. 13, 1981, 95 Stat. 716; Pub. L. 94–278, title V, § 502(a)(1), Apr. 22, 1976, 90 Stat. 411; Pub. L. 95–203, § 4(a)(1), (b)(1), Nov. 23, 1977, 91 Stat. 1452, 1453; Pub. L. 101–535, §§ 2(a), 3(a), 7, Nov. 8, 1990, 104 Stat. 2353, 2357, 2364; Pub. L. 102–108, § 2(a), (c), Aug. 17, 1991, 105 Stat. 549; Pub. L. 102–571, title I, § 107(5), (6), Oct. 29, 1992, 106 Stat. 4499; Pub. L. 103–80, §§ 2(b), 3(j), Aug. 13, 1993, 107 Stat. 773, 776; Pub. L. 103–417, §§ 6, 7(a)–(c), 10(c), Oct. 25, 1994, 108 Stat. 4329, 4330, 4332; Pub. L. 104–124, § 1, Apr. 1, 1996, 110 Stat. 882; Pub. L. 105–115, title III, §§ 301–305, Nov. 21, 1997, 111 Stat. 2350–2353; Pub. L. 106–554, § 1(a)(1) [title V, § 517], Dec. 21, 2000, 114 Stat. 2763, 2763A–73; Pub. L. 107–171, title X, §§ 10806(a)(2), (b)(2), 10808(b), May 13, 2002, 116 Stat. 526, 527, 530; Pub. L. 107–188, title III, § 308(b), June 12, 2002, 116 Stat. 672; Pub. L. 108–282, title II, § 203(a), Aug. 2, 2004, 118 Stat. 906; Pub. L. 109–462, § 3(c), Dec. 22, 2006, 120 Stat. 3475; Pub. L. 111–148, title IV, § 4205(a), (b), Mar. 23, 2010, 124 Stat. 573.)
§ 343–1. National uniform nutrition labeling
(a) Except as provided in subsection (b), no State or political subdivision of a State may directly or indirectly establish under any authority or continue in effect as to any food in interstate commerce—
(1) any requirement for a food which is the subject of a standard of identity established under section 341 of this title that is not identical to such standard of identity or that is not identical to the requirement of section 343(g) of this title, except that this paragraph does not apply to a standard of identity of a State or political subdivision of a State for maple syrup that is of the type required by sections 341 and 343(g) of this title,
(2) any requirement for the labeling of food of the type required by section 343(c), 343(e), 343(i)(2), 343(w), or 343(x) of this title that is not identical to the requirement of such section, except that this paragraph does not apply to a requirement of a State or political subdivision of a State that is of the type required by section 343(c) of this title and that is applicable to maple syrup,
(3) any requirement for the labeling of food of the type required by section 343(b), 343(d), 343(f), 343(h), 343(i)(1), or 343(k) of this title that is not identical to the requirement of such section, except that this paragraph does not apply to a requirement of a State or political subdivision of a State that is of the type required by section 343(h)(1) of this title and that is applicable to maple syrup,
(4) any requirement for nutrition labeling of food that is not identical to the requirement of section 343(q) of this title, except that this paragraph does not apply to food that is offered for sale in a restaurant or similar retail food establishment that is not part of a chain with 20 or more locations doing business under the same name (regardless of the type of ownership of the locations) and offering for sale substantially the same menu items unless such restaurant or similar retail food establishment complies with the voluntary provision of nutrition information requirements under section 343(q)(5)(H)(ix) of this title, or
(5) any requirement respecting any claim of the type described in section 343(r)(1) of this title made in the label or labeling of food that is not identical to the requirement of section 343(r) of this title, except a requirement respecting a claim made in the label or labeling of food which is exempt under section 343(r)(5)(B) of this title.
Paragraph (3) shall take effect in accordance with section 6(b) of the Nutrition Labeling and Education Act of 1990.
(b) Upon petition of a State or a political subdivision of a State, the Secretary may exempt from subsection (a), under such conditions as may be prescribed by regulation, any State or local requirement that—
(1) would not cause any food to be in violation of any applicable requirement under Federal law,
(2) would not unduly burden interstate commerce, and
(3) is designed to address a particular need for information which need is not met by the requirements of the sections referred to in subsection (a).
(June 25, 1938, ch. 675, § 403A, as added Pub. L. 101–535, § 6(a), Nov. 8, 1990, 104 Stat. 2362; amended Pub. L. 102–108, § 2(b), Aug. 17, 1991, 105 Stat. 549; Pub. L. 103–396, § 3(a), Oct. 22, 1994, 108 Stat. 4154; Pub. L. 108–282, title II, § 203(c)(2), Aug. 2, 2004, 118 Stat. 908; Pub. L. 111–148, title IV, § 4205(c), Mar. 23, 2010, 124 Stat. 576.)
§ 343–2. Dietary supplement labeling exemptions
(a) In general
A publication, including an article, a chapter in a book, or an official abstract of a peer-reviewed scientific publication that appears in an article and was prepared by the author or the editors of the publication, which is reprinted in its entirety, shall not be defined as labeling when used in connection with the sale of a dietary supplement to consumers when it—
(1) is not false or misleading;
(2) does not promote a particular manufacturer or brand of a dietary supplement;
(3) is displayed or presented, or is displayed or presented with other such items on the same subject matter, so as to present a balanced view of the available scientific information on a dietary supplement;
(4) if displayed in an establishment, is physically separate from the dietary supplements; and
(5) does not have appended to it any information by sticker or any other method.
(b) Application
(c) Burden of proof
(June 25, 1938, ch. 675, § 403B, as added Pub. L. 103–417, § 5, Oct. 25, 1994, 108 Stat. 4328.)
§ 343–3. Disclosure
(a) No provision of section 321(n), 343(a), or 348 of this title shall be construed to require on the label or labeling of a food a separate radiation disclosure statement that is more prominent than the declaration of ingredients required by section 343(i)(2) of this title.
(b) In this section, the term “radiation disclosure statement” means a written statement that discloses that a food has been intentionally subject to radiation.
(June 25, 1938, ch. 675, § 403C, as added Pub. L. 105–115, title III, § 306, Nov. 21, 1997, 111 Stat. 2353.)
§ 343a. Repealed. Pub. L. 106–554, § 1(a)(1) [title V, § 517], Dec. 21, 2000, 114 Stat. 2763, 2763A–73
§ 344. Emergency permit control
(a) Conditions on manufacturing, processing, etc., as health measure
(b) Violation of permit; suspension and reinstatement
(c) Inspection of permit-holding establishments
(June 25, 1938, ch. 675, § 404, 52 Stat. 1048.)
§ 345. Regulations making exemptions
The Secretary shall promulgate regulations exempting from any labeling requirement of this chapter (1) small open containers of fresh fruits and fresh vegetables and (2) food which is, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantities at establishments other than those where originally processed or packed, on condition that such food is not adulterated or misbranded under the provisions of this chapter upon removal from such processing, labeling, or repacking establishment. This section does not apply to the labeling requirements of sections 343(q) and 343(r) of this title.
(June 25, 1938, ch. 675, § 405, 52 Stat. 1049; Pub. L. 101–535, § 5(a), Nov. 8, 1990, 104 Stat. 2362.)
§ 346. Tolerances for poisonous or deleterious substances in food; regulations
(June 25, 1938, ch. 675, § 406, 52 Stat. 1049; Pub. L. 85–929, § 3(c), Sept. 6, 1958, 72 Stat. 1785; Pub. L. 86–618, title I, § 103(a)(1), July 12, 1960, 74 Stat. 398.)
§ 346a. Tolerances and exemptions for pesticide chemical residues
(a) Requirement for tolerance or exemption
(1) General ruleExcept as provided in paragraph (2) or (3), any pesticide chemical residue in or on a food shall be deemed unsafe for the purpose of section 342(a)(2)(B) of this title unless—
(A) a tolerance for such pesticide chemical residue in or on such food is in effect under this section and the quantity of the residue is within the limits of the tolerance; or
(B) an exemption from the requirement of a tolerance is in effect under this section for the pesticide chemical residue.
For the purposes of this section, the term “food”, when used as a noun without modification, shall mean a raw agricultural commodity or processed food.
(2) Processed foodNotwithstanding paragraph (1)—
(A) if a tolerance is in effect under this section for a pesticide chemical residue in or on a raw agricultural commodity, a pesticide chemical residue that is present in or on a processed food because the food is made from that raw agricultural commodity shall not be considered unsafe within the meaning of section 342(a)(2)(B) of this title despite the lack of a tolerance for the pesticide chemical residue in or on the processed food if the pesticide chemical has been used in or on the raw agricultural commodity in conformity with a tolerance under this section, such residue in or on the raw agricultural commodity has been removed to the extent possible in good manufacturing practice, and the concentration of the pesticide chemical residue in the processed food is not greater than the tolerance prescribed for the pesticide chemical residue in the raw agricultural commodity; or
(B) if an exemption for the requirement for a tolerance is in effect under this section for a pesticide chemical residue in or on a raw agricultural commodity, a pesticide chemical residue that is present in or on a processed food because the food is made from that raw agricultural commodity shall not be considered unsafe within the meaning of section 342(a)(2)(B) of this title.
(3) Residues of degradation productsIf a pesticide chemical residue is present in or on a food because it is a metabolite or other degradation product of a precursor substance that itself is a pesticide chemical or pesticide chemical residue, such a residue shall not be considered to be unsafe within the meaning of section 342(a)(2)(B) of this title despite the lack of a tolerance or exemption from the need for a tolerance for such residue in or on such food if—
(A) the Administrator has not determined that the degradation product is likely to pose any potential health risk from dietary exposure that is of a different type than, or of a greater significance than, any risk posed by dietary exposure to the precursor substance;
(B) either—
(i) a tolerance is in effect under this section for residues of the precursor substance in or on the food, and the combined level of residues of the degradation product and the precursor substance in or on the food is at or below the stoichiometrically equivalent level that would be permitted by the tolerance if the residue consisted only of the precursor substance rather than the degradation product; or
(ii) an exemption from the need for a tolerance is in effect under this section for residues of the precursor substance in or on the food; and
(C) the tolerance or exemption for residues of the precursor substance does not state that it applies only to particular named substances and does not state that it does not apply to residues of the degradation product.
(4) Effect of tolerance or exemption
(b) Authority and standard for tolerance
(1) AuthorityThe Administrator may issue regulations establishing, modifying, or revoking a tolerance for a pesticide chemical residue in or on a food—
(A) in response to a petition filed under subsection (d); or
(B) on the Administrator’s own initiative under subsection (e).
As used in this section, the term “modify” shall not mean expanding the tolerance to cover additional foods.
(2) Standard
(A) General rule
(i) Standard
(ii) Determination of safety
(iii) Rule of construction
(B) Tolerances for eligible pesticide chemical residues
(i) DefinitionAs used in this subparagraph, the term “eligible pesticide chemical residue” means a pesticide chemical residue as to which—(I) the Administrator is not able to identify a level of exposure to the residue at which the residue will not cause or contribute to a known or anticipated harm to human health (referred to in this section as a “nonthreshold effect”);(II) the lifetime risk of experiencing the nonthreshold effect is appropriately assessed by quantitative risk assessment; and(III) with regard to any known or anticipated harm to human health for which the Administrator is able to identify a level at which the residue will not cause such harm (referred to in this section as a “threshold effect”), the Administrator determines that the level of aggregate exposure is safe.
(ii) Determination of toleranceNotwithstanding subparagraph (A)(i), a tolerance for an eligible pesticide chemical residue may be left in effect or modified under this subparagraph if—(I) at least one of the conditions described in clause (iii) is met; and(II) both of the conditions described in clause (iv) are met.
(iii) Conditions regarding useFor purposes of clause (ii), the conditions described in this clause with respect to a tolerance for an eligible pesticide chemical residue are the following:(I) Use of the pesticide chemical that produces the residue protects consumers from adverse effects on health that would pose a greater risk than the dietary risk from the residue.(II) Use of the pesticide chemical that produces the residue is necessary to avoid a significant disruption in domestic production of an adequate, wholesome, and economical food supply.
(iv) Conditions regarding riskFor purposes of clause (ii), the conditions described in this clause with respect to a tolerance for an eligible pesticide chemical residue are the following:(I) The yearly risk associated with the nonthreshold effect from aggregate exposure to the residue does not exceed 10 times the yearly risk that would be allowed under subparagraph (A) for such effect.(II) The tolerance is limited so as to ensure that the risk over a lifetime associated with the nonthreshold effect from aggregate exposure to the residue is not greater than twice the lifetime risk that would be allowed under subparagraph (A) for such effect.
(v) Review
(vi) Infants and children
(C) Exposure of infants and childrenIn establishing, modifying, leaving in effect, or revoking a tolerance or exemption for a pesticide chemical residue, the Administrator—
(i) shall assess the risk of the pesticide chemical residue based on—(I) available information about consumption patterns among infants and children that are likely to result in disproportionately high consumption of foods containing or bearing such residue among infants and children in comparison to the general population;(II) available information concerning the special susceptibility of infants and children to the pesticide chemical residues, including neurological differences between infants and children and adults, and effects of in utero exposure to pesticide chemicals; and(III) available information concerning the cumulative effects on infants and children of such residues and other substances that have a common mechanism of toxicity; and
(ii) shall—(I) ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue; and(II) publish a specific determination regarding the safety of the pesticide chemical residue for infants and children.
The Secretary of Health and Human Services and the Secretary of Agriculture, in consultation with the Administrator, shall conduct surveys to document dietary exposure to pesticides among infants and children. In the case of threshold effects, for purposes of clause (ii)(I) an additional tenfold margin of safety for the pesticide chemical residue and other sources of exposure shall be applied for infants and children to take into account potential pre- and post-natal toxicity and completeness of the data with respect to exposure and toxicity to infants and children. Notwithstanding such requirement for an additional margin of safety, the Administrator may use a different margin of safety for the pesticide chemical residue only if, on the basis of reliable data, such margin will be safe for infants and children.
(D) FactorsIn establishing, modifying, leaving in effect, or revoking a tolerance or exemption for a pesticide chemical residue, the Administrator shall consider, among other relevant factors—
(i) the validity, completeness, and reliability of the available data from studies of the pesticide chemical and pesticide chemical residue;
(ii) the nature of any toxic effect shown to be caused by the pesticide chemical or pesticide chemical residue in such studies;
(iii) available information concerning the relationship of the results of such studies to human risk;
(iv) available information concerning the dietary consumption patterns of consumers (and major identifiable subgroups of consumers);
(v) available information concerning the cumulative effects of such residues and other substances that have a common mechanism of toxicity;
(vi) available information concerning the aggregate exposure levels of consumers (and major identifiable subgroups of consumers) to the pesticide chemical residue and to other related substances, including dietary exposure under the tolerance and all other tolerances in effect for the pesticide chemical residue, and exposure from other non-occupational sources;
(vii) available information concerning the variability of the sensitivities of major identifiable subgroups of consumers;
(viii) such information as the Administrator may require on whether the pesticide chemical may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen or other endocrine effects; and
(ix) safety factors which in the opinion of experts qualified by scientific training and experience to evaluate the safety of food additives are generally recognized as appropriate for the use of animal experimentation data.
(E) Data and information regarding anticipated and actual residue levels
(i) Authority
(ii) Requirement
(F) Percent of food actually treatedIn establishing, modifying, leaving in effect, or revoking a tolerance for a pesticide chemical residue, the Administrator may, when assessing chronic dietary risk, consider available data and information on the percent of food actually treated with the pesticide chemical (including aggregate pesticide use data collected by the Department of Agriculture) only if the Administrator—
(i) finds that the data are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain such pesticide chemical residue;
(ii) finds that the exposure estimate does not understate exposure for any significant subpopulation group;
(iii) finds that, if data are available on pesticide use and consumption of food in a particular area, the population in such area is not dietarily exposed to residues above those estimated by the Administrator; and
(iv) provides for the periodic reevaluation of the estimate of anticipated dietary exposure.
(3) Detection methods
(A) General rule
(B) Detection limit
(4) International standards
(c) Authority and standard for exemptions
(1) AuthorityThe Administrator may issue a regulation establishing, modifying, or revoking an exemption from the requirement for a tolerance for a pesticide chemical residue in or on food—
(A) in response to a petition filed under subsection (d); or
(B) on the Administrator’s initiative under subsection (e).
(2) Standard
(A) General rule
(i) Standard
(ii) Determination of safety
(B) Factors
(3) LimitationAn exemption from the requirement for a tolerance for a pesticide chemical residue in or on food shall not be established or modified by the Administrator unless the Administrator determines, after consultation with the Secretary—
(A) that there is a practical method for detecting and measuring the levels of such pesticide chemical residue in or on food; or
(B) that there is no need for such a method, and states the reasons for such determination in issuing the regulation establishing or modifying the exemption.
(d) Petition for tolerance or exemption
(1) Petitions and petitionersAny person may file with the Administrator a petition proposing the issuance of a regulation—
(A) establishing, modifying, or revoking a tolerance for a pesticide chemical residue in or on a food; or
(B) establishing, modifying, or revoking an exemption from the requirement of a tolerance for such a residue.
(2) Petition contents
(A) EstablishmentA petition under paragraph (1) to establish a tolerance or exemption for a pesticide chemical residue shall be supported by such data and information as are specified in regulations issued by the Administrator, including—
(i)(I) an informative summary of the petition and of the data, information, and arguments submitted or cited in support of the petition; and(II) a statement that the petitioner agrees that such summary or any information it contains may be published as a part of the notice of filing of the petition to be published under this subsection and as part of a proposed or final regulation issued under this section;
(ii) the name, chemical identity, and composition of the pesticide chemical residue and of the pesticide chemical that produces the residue;
(iii) data showing the recommended amount, frequency, method, and time of application of that pesticide chemical;
(iv) full reports of tests and investigations made with respect to the safety of the pesticide chemical, including full information as to the methods and controls used in conducting those tests and investigations;
(v) full reports of tests and investigations made with respect to the nature and amount of the pesticide chemical residue that is likely to remain in or on the food, including a description of the analytical methods used;
(vi) a practical method for detecting and measuring the levels of the pesticide chemical residue in or on the food, or for exemptions, a statement why such a method is not needed;
(vii) a proposed tolerance for the pesticide chemical residue, if a tolerance is proposed;
(viii) if the petition relates to a tolerance for a processed food, reports of investigations conducted using the processing method(s) used to produce that food;
(ix) such information as the Administrator may require to make the determination under subsection (b)(2)(C);
(x) such information as the Administrator may require on whether the pesticide chemical may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen or other endocrine effects;
(xi) information regarding exposure to the pesticide chemical residue due to any tolerance or exemption already granted for such residue;
(xii) practical methods for removing any amount of the residue that would exceed any proposed tolerance; and
(xiii) such other data and information as the Administrator requires by regulation to support the petition.
If information or data required by this subparagraph is available to the Administrator, the person submitting the petition may cite the availability of the information or data in lieu of submitting it. The Administrator may require a petition to be accompanied by samples of the pesticide chemical with respect to which the petition is filed.
(B) Modification or revocation
(3) Notice
(4) Actions by the Administrator
(A) In generalThe Administrator shall, after giving due consideration to a petition filed under paragraph (1) and any other information available to the Administrator—
(i) issue a final regulation (which may vary from that sought by the petition) establishing, modifying, or revoking a tolerance for the pesticide chemical residue or an exemption of the pesticide chemical residue from the requirement of a tolerance (which final regulation shall be issued without further notice and without further period for public comment);
(ii) issue a proposed regulation under subsection (e), and thereafter issue a final regulation under such subsection; or
(iii) issue an order denying the petition.
(B) Priorities
(C) Expedited review of certain petitions
(i) Date certain for review
(ii) Required determinations
(e) Action on Administrator’s own initiative
(1) General ruleThe Administrator may issue a regulation—
(A) establishing, modifying, suspending under subsection (l)(3), or revoking a tolerance for a pesticide chemical or a pesticide chemical residue;
(B) establishing, modifying, suspending under subsection (l)(3), or revoking an exemption of a pesticide chemical residue from the requirement of a tolerance; or
(C) establishing general procedures and requirements to implement this section.
(2) Notice
(f) Special data requirements
(1) Requiring submission of additional dataIf the Administrator determines that additional data or information are reasonably required to support the continuation of a tolerance or exemption that is in effect under this section for a pesticide chemical residue on a food, the Administrator shall—
(A) issue a notice requiring the person holding the pesticide registrations associated with such tolerance or exemption to submit the data or information under section 3(c)(2)(B) of the Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136a(c)(2)(B)];
(B) issue a rule requiring that testing be conducted on a substance or mixture under section 4 of the Toxic Substances Control Act [15 U.S.C. 2603]; or
(C) publish in the Federal Register, after first providing notice and an opportunity for comment of not less than 60 days’ duration, an order—
(i) requiring the submission to the Administrator by one or more interested persons of a notice identifying the person or persons who will submit the required data and information;
(ii) describing the type of data and information required to be submitted to the Administrator and stating why the data and information could not be obtained under the authority of section 3(c)(2)(B) of the Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136a(c)(2)(B)] or section 4 of the Toxic Substances Control Act [15 U.S.C. 2603];
(iii) describing the reports of the Administrator required to be prepared during and after the collection of the data and information;
(iv) requiring the submission to the Administrator of the data, information, and reports referred to in clauses (ii) and (iii); and
(v) establishing dates by which the submissions described in clauses (i) and (iv) must be made.
The Administrator may under subparagraph (C) revise any such order to correct an error. The Administrator may under this paragraph require data or information pertaining to whether the pesticide chemical may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen or other endocrine effects.
(2) Noncompliance
(g) Effective date, objections, hearings, and administrative review
(1) Effective date
(2) Further proceedings
(A) Objections
(B) Hearing
(C) Final decision
(h) Judicial review
(1) Petition
(2) Record and jurisdiction
(3) Additional evidence
(4) Final judgment; Supreme Court review
(5) Application
(i) Confidentiality and use of data
(1) General rule
(2) Exceptions
(A) In generalData and information that are entitled to confidential treatment under paragraph (1) may be disclosed, under such security requirements as the Administrator may provide by regulation, to—
(i) employees of the United States authorized by the Administrator to examine such data and information in the carrying out of their official duties under this chapter or other Federal statutes intended to protect the public health; or
(ii) contractors with the United States authorized by the Administrator to examine such data and information in the carrying out of contracts under this chapter or such statutes.
(B) Congress
(3) Summaries
(j) Status of previously issued regulations
(1) Regulations under section 346
(2) Regulations under section 348
(3) Regulations under section 346a
(4) Certain substancesWith respect to a substance that is not included in the definition of the term “pesticide chemical” under section 321(q)(1) of this title but was so included on the day before October 30, 1998, the following applies as of October 30, 1998:
(A) Notwithstanding paragraph (2), any regulation applying to the use of the substance that was in effect on the day before October 30, 1998, and was on such day deemed in such paragraph to have been issued under this section, shall be considered to have been issued under section 348 of this title.
(B) Notwithstanding paragraph (3), any regulation applying to the use of the substance that was in effect on such day and was issued under this section (including any such regulation issued before August 3, 1996) is deemed to have been issued under section 348 of this title.
(k) Transitional provisionIf, on the day before August 3, 1996, a substance that is a pesticide chemical was, with respect to a particular pesticidal use of the substance and any resulting pesticide chemical residue in or on a particular food—
(1) regarded by the Administrator or the Secretary as generally recognized as safe for use within the meaning of the provisions of subsection (a) or section 321(s) of this title as then in effect; or
(2) regarded by the Secretary as a substance described by section 321(s)(4) of this title;
such a pesticide chemical residue shall be regarded as exempt from the requirement for a tolerance, as of August 3, 1996. The Administrator shall by regulation indicate which substances are described by this subsection. Any exemption under this subsection may be modified or revoked as if it had been issued under subsection (c).
(l) Harmonization with action under other laws
(1) Coordination with FIFRA
(2) Revocation of tolerance or exemption following cancellation of associated registrationsIf the Administrator, acting under the Federal Insecticide, Fungicide, and Rodenticide Act, cancels the registration of each pesticide that contains a particular pesticide chemical and that is labeled for use on a particular food, or requires that the registration of each such pesticide be modified to prohibit its use in connection with the production, storage, or transportation of such food, due in whole or in part to dietary risks to humans posed by residues of that pesticide chemical on that food, the Administrator shall revoke any tolerance or exemption that allows the presence of the pesticide chemical, or any pesticide chemical residue that results from its use, in or on that food. Subsection (e) shall apply to actions taken under this paragraph. A revocation under this paragraph shall become effective not later than 180 days after—
(A) the date by which each such cancellation of a registration has become effective; or
(B) the date on which the use of the canceled pesticide becomes unlawful under the terms of the cancellation, whichever is later.
(3) Suspension of tolerance or exemption following suspension of associated registrations
(A) Suspension
(B) Effect of suspension
(4) Tolerances for unavoidable residues
(5) Pesticide residues resulting from lawful application of pesticideNotwithstanding any other provision of this chapter, if a tolerance or exemption for a pesticide chemical residue in or on a food has been revoked, suspended, or modified under this section, an article of that food shall not be deemed unsafe solely because of the presence of such pesticide chemical residue in or on such food if it is shown to the satisfaction of the Secretary that—
(A) the residue is present as the result of an application or use of a pesticide at a time and in a manner that was lawful under the Federal Insecticide, Fungicide, and Rodenticide Act; and
(B) the residue does not exceed a level that was authorized at the time of that application or use to be present on the food under a tolerance, exemption, food additive regulation, or other sanction then in effect under this chapter;
unless, in the case of any tolerance or exemption revoked, suspended, or modified under this subsection or subsection (d) or (e), the Administrator has issued a determination that consumption of the legally treated food during the period of its likely availability in commerce will pose an unreasonable dietary risk.
(6) Tolerance for use of pesticides under an emergency exemption
(m) Fees
(1) AmountThe Administrator shall by regulation require the payment of such fees as will in the aggregate, in the judgment of the Administrator, be sufficient over a reasonable term to provide, equip, and maintain an adequate service for the performance of the Administrator’s functions under this section. Under the regulations, the performance of the Administrator’s services or other functions under this section, including—
(A) the acceptance for filing of a petition submitted under subsection (d);
(B) establishing, modifying, leaving in effect, or revoking a tolerance or establishing, modifying, leaving in effect, or revoking an exemption from the requirement for a tolerance under this section;
(C) the acceptance for filing of objections under subsection (g); or
(D) the certification and filing in court of a transcript of the proceedings and the record under subsection (h);
may be conditioned upon the payment of such fees. The regulations may further provide for waiver or refund of fees in whole or in part when in the judgment of the Administrator such a waiver or refund is equitable and not contrary to the purposes of this subsection.
(2) Deposit
(3) Prohibition
(n) National uniformity of tolerances
(1) “Qualifying pesticide chemical residue” definedFor purposes of this subsection, the term “qualifying pesticide chemical residue” means a pesticide chemical residue resulting from the use, in production, processing, or storage of a food, of a pesticide chemical that is an active ingredient and that—
(A) was first approved for such use in a registration of a pesticide issued under section 3(c)(5) of the Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136a(c)(5)] on or after April 25, 1985, on the basis of data determined by the Administrator to meet all applicable requirements for data prescribed by regulations in effect under that Act [7 U.S.C. 136 et seq.] on April 25, 1985; or
(B) was approved for such use in a reregistration eligibility determination issued under section 4(g) of that Act [7 U.S.C. 136a–1(g)] on or after August 3, 1996.
(2) “Qualifying Federal determination” definedFor purposes of this subsection, the term “qualifying Federal determination” means a tolerance or exemption from the requirement for a tolerance for a qualifying pesticide chemical residue that—
(A) is issued under this section after August 3, 1996, and determined by the Administrator to meet the standard under subsection (b)(2)(A) (in the case of a tolerance) or (c)(2) (in the case of an exemption); or
(B)
(i) pursuant to subsection (j) is remaining in effect or is deemed to have been issued under this section, or is regarded under subsection (k) as exempt from the requirement for a tolerance; and
(ii) is determined by the Administrator to meet the standard under subsection (b)(2)(A) (in the case of a tolerance) or (c)(2) (in the case of an exemption).
(3) Limitation
(4) State authority
(5) Petition procedure
(A) In general
(B) Petition requirementsAny petition under subparagraph (A) shall—
(i) satisfy any requirements prescribed, by rule, by the Administrator; and
(ii) be supported by scientific data about the pesticide chemical residue that is the subject of the petition or about chemically related pesticide chemical residues, data on the consumption within such State of food bearing the pesticide chemical residue, and data on exposure of humans within such State to the pesticide chemical residue.
(C) AuthorizationThe Administrator may, by order, grant the authorization described in subparagraph (A) if the Administrator determines that the proposed State regulatory limit—
(i) is justified by compelling local conditions; and
(ii) would not cause any food to be a violation of Federal law.
(D) Treatment
(E) Review
(6) Urgent petition procedure
(7) Residues from lawful application
(8) Savings
(o) Consumer right to knowNot later than 2 years after August 3, 1996, and annually thereafter, the Administrator shall, in consultation with the Secretary of Agriculture and the Secretary of Health and Human Services, publish in a format understandable to a lay person, and distribute to large retail grocers for public display (in a manner determined by the grocer), the following information, at a minimum:
(1) A discussion of the risks and benefits of pesticide chemical residues in or on food purchased by consumers.
(2) A listing of actions taken under subparagraph (B) of subsection (b)(2) that may result in pesticide chemical residues in or on food that present a yearly or lifetime risk above the risk allowed under subparagraph (A) of such subsection, and the food on which the pesticide chemicals producing the residues are used.
(3) Recommendations to consumers for reducing dietary exposure to pesticide chemical residues in a manner consistent with maintaining a healthy diet, including a list of food that may reasonably substitute for food listed under paragraph (2).
Nothing in this subsection shall prevent retail grocers from providing additional information.
(p) Estrogenic substances screening program
(1) Development
(2) Implementation
(3) SubstancesIn carrying out the screening program described in paragraph (1), the Administrator—
(A) shall provide for the testing of all pesticide chemicals; and
(B) may provide for the testing of any other substance that may have an effect that is cumulative to an effect of a pesticide chemical if the Administrator determines that a substantial population may be exposed to such substance.
(4) Exemption
(5) Collection of information
(A) In general
(B) Procedures
(C) Failure of registrants to submit information
(i) Suspension
(ii) Hearing
(iii) Termination of suspensions
(D) Noncompliance by other persons
(6) Agency action
(7) Report to CongressNot later than 4 years after August 3, 1996, the Administrator shall prepare and submit to Congress a report containing—
(A) the findings of the Administrator resulting from the screening program described in paragraph (1);
(B) recommendations for further testing needed to evaluate the impact on human health of the substances tested under the screening program; and
(C) recommendations for any further actions (including any action described in paragraph (6)) that the Administrator determines are appropriate based on the findings.
(q) Schedule for review
(1) In generalThe Administrator shall review tolerances and exemptions for pesticide chemical residues in effect on the day before August 3, 1996, as expeditiously as practicable, assuring that—
(A) 33 percent of such tolerances and exemptions are reviewed within 3 years of August 3, 1996;
(B) 66 percent of such tolerances and exemptions are reviewed within 6 years of August 3, 1996; and
(C) 100 percent of such tolerances and exemptions are reviewed within 10 years of August 3, 1996.
In conducting a review of a tolerance or exemption, the Administrator shall determine whether the tolerance or exemption meets the requirements of subsections 2
2 So in original. Probably should be “subsection”.
(b)(2) or (c)(2) and shall, by the deadline for the review of the tolerance or exemption, issue a regulation under subsection (d)(4) or (e)(1) to modify or revoke the tolerance or exemption if the tolerance or exemption does not meet such requirements.(2) Priorities
(3) Publication of schedule
(r) Temporary tolerance or exemption
(s) Savings clause
(June 25, 1938, ch. 675, § 408, as added July 22, 1954, ch. 559, § 3, 68 Stat. 511; amended Pub. L. 85–791, § 20, Aug. 28, 1958, 72 Stat. 947; Pub. L. 91–515, title VI, § 601(d)(1), Oct. 30, 1970, 84 Stat. 1311; Pub. L. 92–157, title III, § 303(a), Nov. 18, 1971, 85 Stat. 464; Pub. L. 92–516, § 3(3), Oct. 21, 1972, 86 Stat. 998; Pub. L. 98–620, title IV, § 402(25)(A), Nov. 8, 1984, 98 Stat. 3359; Pub. L. 102–300, § 6(b)(1), June 16, 1992, 106 Stat. 240; Pub. L. 102–571, title I, § 107(7), Oct. 29, 1992, 106 Stat. 4499; Pub. L. 103–80, § 3(k), Aug. 13, 1993, 107 Stat. 776; Pub. L. 104–170, title IV, § 405, Aug. 3, 1996, 110 Stat. 1514; Pub. L. 105–324, § 2(b), Oct. 30, 1998, 112 Stat. 3036; Pub. L. 110–94, § 4(d)(2), Oct. 9, 2007, 121 Stat. 1002; Pub. L. 112–177, § 2(a)(3), Sept. 28, 2012, 126 Stat. 1329; Pub. L. 116–8, § 2(c), Mar. 8, 2019, 133 Stat. 485; Pub. L. 117–328, div. HH, title VI, § 703(b), Dec. 29, 2022, 136 Stat. 6002.)
§ 346b. Authorization of appropriations
There are authorized to be appropriated, out of any moneys in the Treasury not otherwise appropriated, such sums as may be necessary for the purpose and administration of sections 321(q), (r), 342(a)(2), and 346a of this title.
(July 22, 1954, ch. 559, § 4, 68 Stat. 517.)
§ 347. Intrastate sales of colored oleomargarine
(a) Law governing
(b) Labeling and packaging requirements
No person shall sell, or offer for sale, colored oleomargarine or colored margarine unless—
(1) such oleomargarine or margarine is packaged,
(2) the net weight of the contents of any package sold in a retail establishment is one pound or less,
(3) there appears on the label of the package (A) the word “oleomargarine” or “margarine” in type or lettering at least as large as any other type or lettering on such label, and (B) a full and accurate statement of all the ingredients contained in such oleomargarine or margarine, and
(4) each part of the contents of the package is contained in a wrapper which bears the word “oleomargarine” or “margarine” in type or lettering not smaller than 20-point type.
The requirements of this subsection shall be in addition to and not in lieu of any of the other requirements of this chapter.
(c) Sales in public eating places
(d) Exemption from labeling requirements
(e) Color span of oleomargarine
(June 25, 1938, ch. 675, § 407, as added Mar. 16, 1950, ch. 61, § 3(c), 64 Stat. 20.)
§ 347a. Congressional declaration of policy regarding oleomargarine sales
The Congress hereby finds and declares that the sale, or the serving in public eating places, of colored oleomargarine or colored margarine without clear identification as such or which is otherwise adulterated or misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] depresses the market in interstate commerce for butter and for oleomargarine or margarine clearly identified and neither adulterated nor misbranded, and constitutes a burden on interstate commerce in such articles. Such burden exists, irrespective of whether such oleomargarine or margarine originates from an interstate source or from the State in which it is sold.
(Mar. 16, 1950, ch. 61, § 3(a), 64 Stat. 20.)
§ 347b. Contravention of State laws
Nothing in this Act shall be construed as authorizing the possession, sale, or serving of colored oleomargarine or colored margarine in any State or Territory in contravention of the laws of such State or Territory.
(Mar. 16, 1950, ch. 61, § 6, 64 Stat. 22.)
§ 348. Food additives
(a) Unsafe food additives; exception for conformity with exemption or regulationA food additive shall, with respect to any particular use or intended use of such additives, be deemed to be unsafe for the purposes of the application of clause (2)(C) of section 342(a) of this title, unless—
(1) it and its use or intended use conform to the terms of an exemption which is in effect pursuant to subsection (j) of this section;
(2) there is in effect, and it and its use or intended use are in conformity with, a regulation issued under this section prescribing the conditions under which such additive may be safely used; or
(3) in the case of a food additive as defined in this chapter that is a food contact substance, there is—
(A) in effect, and such substance and the use of such substance are in conformity with, a regulation issued under this section prescribing the conditions under which such additive may be safely used; or
(B) a notification submitted under subsection (h) that is effective.
While such a regulation relating to a food additive, or such a notification under subsection (h)(1) relating to a food additive that is a food contact substance, is in effect, and has not been revoked pursuant to subsection (i), a food shall not, by reason of bearing or containing such a food additive in accordance with the regulation or notification, be considered adulterated under section 342(a)(1) of this title.
(b) Petition for regulation prescribing conditions of safe use; contents; description of production methods and controls; samples; notice of regulation
(1) Any person may, with respect to any intended use of a food additive, file with the Secretary a petition proposing the issuance of a regulation prescribing the conditions under which such additive may be safely used.
(2) Such petition shall, in addition to any explanatory or supporting data, contain—
(A) the name and all pertinent information concerning such food additive, including, where available, its chemical identity and composition;
(B) a statement of the conditions of the proposed use of such additive, including all directions, recommendations, and suggestions proposed for the use of such additive, and including specimens of its proposed labeling;
(C) all relevant data bearing on the physical or other technical effect such additive is intended to produce, and the quantity of such additive required to produce such effect;
(D) a description of practicable methods for determining the quantity of such additive in or on food, and any substance formed in or on food, because of its use; and
(E) full reports of investigations made with respect to the safety for use of such additive, including full information as to the methods and controls used in conducting such investigations.
(3) Upon request of the Secretary, the petitioner shall furnish (or, if the petitioner is not the manufacturer of such additive, the petitioner shall have the manufacturer of such additive furnish, without disclosure to the petitioner) a full description of the methods used in, and the facilities and controls used for, the production of such additive.
(4) Upon request of the Secretary, the petitioner shall furnish samples of the food additive involved, or articles used as components thereof, and of the food in or on which the additive is proposed to be used.
(5) Notice of the regulation proposed by the petitioner shall be published in general terms by the Secretary within thirty days after filing.
(c) Approval or denial of petition; time for issuance of order; evaluation of data; factors
(1) The Secretary shall—
(A) by order establish a regulation (whether or not in accord with that proposed by the petitioner) prescribing, with respect to one or more proposed uses of the food additive involved, the conditions under which such additive may be safely used (including, but not limited to, specifications as to the particular food or classes of food in or in which such additive may be used, the maximum quantity which may be used or permitted to remain in or on such food, the manner in which such additive may be added to or used in or on such food, and any directions or other labeling or packaging requirements for such additive deemed necessary by him to assure the safety of such use), and shall notify the petitioner of such order and the reasons for such action; or
(B) by order deny the petition, and shall notify the petitioner of such order and of the reasons for such action.
(2) The order required by paragraph (1)(A) or (B) of this subsection shall be issued within ninety days after the date of filing of the petition, except that the Secretary may (prior to such ninetieth day), by written notice to the petitioner, extend such ninety-day period to such time (not more than one hundred and eighty days after the date of filing of the petition) as the Secretary deems necessary to enable him to study and investigate the petition.
(3) No such regulation shall issue if a fair evaluation of the data before the Secretary—
(A) fails to establish that the proposed use of the food additive, under the conditions of use to be specified in the regulation, will be safe: Provided, That no additive shall be deemed to be safe if it is found to induce cancer when ingested by man or animal, or if it is found, after tests which are appropriate for the evaluation of the safety of food additives, to induce cancer in man or animal, except that this proviso shall not apply with respect to the use of a substance as an ingredient of feed for animals which are raised for food production, if the Secretary finds (i) that, under the conditions of use and feeding specified in proposed labeling and reasonably certain to be followed in practice, such additive will not adversely affect the animals for which such feed is intended, and (ii) that no residue of the additive will be found (by methods of examination prescribed or approved by the Secretary by regulations, which regulations shall not be subject to subsections (f) and (g)) in any edible portion of such animal after slaughter or in any food yielded by or derived from the living animal; or
(B) shows that the proposed use of the additive would promote deception of the consumer in violation of this chapter or would otherwise result in adulteration or in misbranding of food within the meaning of this chapter.
(4) If, in the judgment of the Secretary, based upon a fair evaluation of the data before him, a tolerance limitation is required in order to assure that the proposed use of an additive will be safe, the Secretary—
(A) shall not fix such tolerance limitation at a level higher than he finds to be reasonably required to accomplish the physical or other technical effect for which such additive is intended; and
(B) shall not establish a regulation for such proposed use if he finds upon a fair evaluation of the data before him that such data do not establish that such use would accomplish the intended physical or other technical effect.
(5) In determining, for the purposes of this section, whether a proposed use of a food additive is safe, the Secretary shall consider among other relevant factors—
(A) the probable consumption of the additive and of any substance formed in or on food because of the use of the additive;
(B) the cumulative effect of such additive in the diet of man or animals, taking into account any chemically or pharmacologically related substance or substances in such diet; and
(C) safety factors which in the opinion of experts qualified by scientific training and experience to evaluate the safety of food additives are generally recognized as appropriate for the use of animal experimentation data.
(d) Regulation issued on Secretary’s initiative
(e) Publication and effective date of orders
(f) Objections and public hearing; basis and contents of order; statement
(1) Within thirty days after publication of an order made pursuant to subsection (c) or (d) of this section, any person adversely affected by such an order may file objections thereto with the Secretary, specifying with particularity the provisions of the order deemed objectionable, stating reasonable grounds therefor, and requesting a public hearing upon such objections. The Secretary shall, after due notice, as promptly as possible hold such public hearing for the purpose of receiving evidence relevant and material to the issues raised by such objections. As soon as practicable after completion of the hearing, the Secretary shall by order act upon such objections and make such order public.
(2) Such order shall be based upon a fair evaluation of the entire record at such hearing, and shall include a statement setting forth in detail the findings and conclusions upon which the order is based.
(3) The Secretary shall specify in the order the date on which it shall take effect, except that it shall not be made to take effect prior to the ninetieth day after its publication, unless the Secretary finds that emergency conditions exist necessitating an earlier effective date, in which event the Secretary shall specify in the order his findings as to such conditions.
(g) Judicial review
(1) In a case of actual controversy as to the validity of any order issued under subsection (f), including any order thereunder with respect to amendment or repeal of a regulation issued under this section, any person who will be adversely affected by such order may obtain judicial review by filing in the United States Court of Appeals for the circuit wherein such person resides or has his principal place of business, or in the United States Court of Appeals for the District of Columbia Circuit, within sixty days after the entry of such order, a petition praying that the order be set aside in whole or in part.
(2) A copy of such petition shall be forthwith transmitted by the clerk of the court to the Secretary, or any officer designated by him for that purpose, and thereupon the Secretary shall file in the court the record of the proceedings on which he based his order, as provided in section 2112 of title 28. Upon the filing of such petition the court shall have jurisdiction, which upon the filing of the record with it shall be exclusive, to affirm or set aside the order complained of in whole or in part. Until the filing of the record the Secretary may modify or set aside his order. The findings of the Secretary with respect to questions of fact shall be sustained if based upon a fair evaluation of the entire record at such hearing.
(3) The court, on such judicial review, shall not sustain the order of the Secretary if he failed to comply with any requirement imposed on him by subsection (f)(2) of this section.
(4) If application is made to the court for leave to adduce additional evidence, the court may order such additional evidence to be taken before the Secretary and to be adduced upon the hearing in such manner and upon such terms and conditions as to the court may seem proper, if such evidence is material and there were reasonable grounds for failure to adduce such evidence in the proceedings below. The Secretary may modify his findings as to the facts and order by reason of the additional evidence so taken, and shall file with the court such modified findings and order.
(5) The judgment of the court affirming or setting aside, in whole or in part, any order under this section shall be final, subject to review by the Supreme Court of the United States upon certiorari or certification as provided in section 1254 of title 28. The commencement of proceedings under this section shall not, unless specifically ordered by the court to the contrary, operate as a stay of an order.
(h) Notification relating to food contact substance
(1) Subject to such regulations as may be promulgated under paragraph (3), a manufacturer or supplier of a food contact substance may, at least 120 days prior to the introduction or delivery for introduction into interstate commerce of the food contact substance, notify the Secretary of the identity and intended use of the food contact substance, and of the determination of the manufacturer or supplier that the intended use of such food contact substance is safe under the standard described in subsection (c)(3)(A). The notification shall contain the information that forms the basis of the determination and all information required to be submitted by regulations promulgated by the Secretary.
(2)
(A) A notification submitted under paragraph (1) shall become effective 120 days after the date of receipt by the Secretary and the food contact substance may be introduced or delivered for introduction into interstate commerce, unless the Secretary makes a determination within the 120-day period that, based on the data and information before the Secretary, such use of the food contact substance has not been shown to be safe under the standard described in subsection (c)(3)(A), and informs the manufacturer or supplier of such determination.
(B) A decision by the Secretary to object to a notification shall constitute final agency action subject to judicial review.
(C) In this paragraph, the term “food contact substance” means the substance that is the subject of a notification submitted under paragraph (1), and does not include a similar or identical substance manufactured or prepared by a person other than the manufacturer identified in the notification.
(3)
(A) The process in this subsection shall be utilized for authorizing the marketing of a food contact substance except where the Secretary determines that submission and review of a petition under subsection (b) is necessary to provide adequate assurance of safety, or where the Secretary and any manufacturer or supplier agree that such manufacturer or supplier may submit a petition under subsection (b).
(B) The Secretary is authorized to promulgate regulations to identify the circumstances in which a petition shall be filed under subsection (b), and shall consider criteria such as the probable consumption of such food contact substance and potential toxicity of the food contact substance in determining the circumstances in which a petition shall be filed under subsection (b).
(4) The Secretary shall keep confidential any information provided in a notification under paragraph (1) for 120 days after receipt by the Secretary of the notification. After the expiration of such 120 days, the information shall be available to any interested party except for any matter in the notification that is a trade secret or confidential commercial information.
(5)
(A)
(i) Except as provided in clause (ii), the notification program established under this subsection shall not operate in any fiscal year unless—(I) an appropriation equal to or exceeding the applicable amount under clause (iv) is made for such fiscal year for carrying out such program in such fiscal year; and(II) the Secretary certifies that the amount appropriated for such fiscal year for the Center for Food Safety and Applied Nutrition of the Food and Drug Administration (exclusive of the appropriation referred to in subclause (I)) equals or exceeds the amount appropriated for the Center for fiscal year 1997, excluding any amount appropriated for new programs.
(ii) The Secretary shall, not later than April 1, 1999, begin accepting and reviewing notifications submitted under the notification program established under this subsection if—(I) an appropriation equal to or exceeding the applicable amount under clause (iii) is made for the last six months of fiscal year 1999 for carrying out such program during such period; and(II) the Secretary certifies that the amount appropriated for such period for the Center for Food Safety and Applied Nutrition of the Food and Drug Administration (exclusive of the appropriation referred to in subclause (I)) equals or exceeds an amount equivalent to one-half the amount appropriated for the Center for fiscal year 1997, excluding any amount appropriated for new programs.
(iii) For the last six months of fiscal year 1999, the applicable amount under this clause is $1,500,000, or the amount specified in the budget request of the President for the six-month period involved for carrying out the notification program in fiscal year 1999, whichever is less.
(iv) For fiscal year 2000 and subsequent fiscal years, the applicable amount under this clause is $3,000,000, or the amount specified in the budget request of the President for the fiscal year involved for carrying out the notification program under this subsection, whichever is less.
(B) For purposes of carrying out the notification program under this subsection, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 1999 through fiscal year 2003, except that such authorization of appropriations is not effective for a fiscal year for any amount that is less than the applicable amount under clause (iii) or (iv) of subparagraph (A), whichever is applicable.
(C) Not later than April 1 of fiscal year 1998 and February 1 of each subsequent fiscal year, the Secretary shall submit a report to the Committees on Appropriations of the House of Representatives and the Senate, the Committee on Commerce of the House of Representatives, and the Committee on Labor and Human Resources of the Senate that provides an estimate of the Secretary of the costs of carrying out the notification program established under this subsection for the next fiscal year.
(6) In this section, the term “food contact substance” means any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have any technical effect in such food.
(i) Amendment or repeal of regulations
(j) Exemptions for investigational use
(k) Food additives intended for use in animal food
(1) In taking action on a petition under subsection (c) for, or for recognition of, a food additive intended for use in animal food, the Secretary shall review reports of investigations conducted in foreign countries, provided by the petitioner.
(2) Not later than 12 months after August 14, 2018, the Secretary shall post on the internet website of the Food and Drug Administration—
(A) the number of petitions for food additives intended for use in animal food filed under subsection (b) that are pending;
(B) how long each such petition submitted under subsection (b) has been pending, including such petitions the Secretary has extended under subsection (c)(2); and
(C) the number of study protocols that have been pending review for over 50 days, and the number that have received an extension.
(3) In the case of a food additive petition intended for use in animal food, the Secretary shall provide information to the petitioner on the required contents of such petition. If the Secretary requires additional studies beyond what the petitioner proposed, the Secretary shall provide the scientific rationale for such requirement.
(June 25, 1938, ch. 675, § 409, as added Pub. L. 85–929, § 4, Sept. 6, 1958, 72 Stat. 1785; amended Pub. L. 86–546, § 2, June 29, 1960, 74 Stat. 255; Pub. L. 87–781, title I, § 104(f)(1), Oct. 10, 1962, 76 Stat. 785; Pub. L. 98–620, title IV, § 402(25)(B), Nov. 8, 1984, 98 Stat. 3359; Pub. L. 105–115, title III, § 309, Nov. 21, 1997, 111 Stat. 2354; Pub. L. 115–234, title III, § 306(a), Aug. 14, 2018, 132 Stat. 2440.)
§ 349. Bottled drinking water standards; publication in Federal Register
(a) Except as provided in subsection (b), whenever the Administrator of the Environmental Protection Agency prescribes interim or revised national primary drinking water regulations under section 1412 of the Public Health Service Act [42 U.S.C. 300g–1], the Secretary shall consult with the Administrator and within 180 days after the promulgation of such drinking water regulations either promulgate amendments to regulations under this chapter applicable to bottled drinking water or publish in the Federal Register his reasons for not making such amendments.
(b)
(1) Not later than 180 days before the effective date of a national primary drinking water regulation promulgated by the Administrator of the Environmental Protection Agency for a contaminant under section 1412 of the Safe Drinking Water Act (42 U.S.C. 300g–1), the Secretary shall promulgate a standard of quality regulation under this subsection for that contaminant in bottled water or make a finding that such a regulation is not necessary to protect the public health because the contaminant is contained in water in public water systems (as defined under section 1401(4) of such Act (42 U.S.C. 300f(4))) but not in water used for bottled drinking water. The effective date for any such standard of quality regulation shall be the same as the effective date for such national primary drinking water regulation, except for any standard of quality of regulation promulgated by the Secretary before August 6, 1996, for which (as of August 6, 1996) an effective date had not been established. In the case of a standard of quality regulation to which such exception applies, the Secretary shall promulgate monitoring requirements for the contaminants covered by the regulation not later than 2 years after August 6, 1996.
(2) A regulation issued by the Secretary as provided in this subsection shall include any monitoring requirements that the Secretary determines appropriate for bottled water.
(3) A regulation issued by the Secretary as provided in this subsection shall require the following:
(A) In the case of contaminants for which a maximum contaminant level is established in a national primary drinking water regulation under section 1412 of the Safe Drinking Water Act (42 U.S.C. 300g–1), the regulation under this subsection shall establish a maximum contaminant level for the contaminant in bottled water which is no less stringent than the maximum contaminant level provided in the national primary drinking water regulation.
(B) In the case of contaminants for which a treatment technique is established in a national primary drinking water regulation under section 1412 of the Safe Drinking Water Act (42 U.S.C. 300g–1), the regulation under this subsection shall require that bottled water be subject to requirements no less protective of the public health than those applicable to water provided by public water systems using the treatment technique required by the national primary drinking water regulation.
(4)
(A) If the Secretary does not promulgate a regulation under this subsection within the period described in paragraph (1), the national primary drinking water regulation referred to in paragraph (1) shall be considered, as of the date on which the Secretary is required to establish a regulation under paragraph (1), as the regulation applicable under this subsection to bottled water.
(B) In the case of a national primary drinking water regulation that pursuant to subparagraph (A) is considered to be a standard of quality regulation, the Secretary shall, not later than the applicable date referred to in such subparagraph, publish in the Federal Register a notice—
(i) specifying the contents of such regulation, including monitoring requirements; and
(ii) providing that for purposes of this paragraph the effective date for such regulation is the same as the effective date for the regulation for purposes of the Safe Drinking Water Act [42 U.S.C. 300f et seq.] (or, if the exception under paragraph (1) applies to the regulation, that the effective date for the regulation is not later than 2 years and 180 days after August 6, 1996).
(June 25, 1938, ch. 675, § 410, as added Pub. L. 93–523, § 4, Dec. 16, 1974, 88 Stat. 1694; amended Pub. L. 104–182, title III, § 305, Aug. 6, 1996, 110 Stat. 1684.)
§ 350. Vitamins and minerals
(a) Authority and limitations of Secretary; applicability
(1) Except as provided in paragraph (2)—
(A) the Secretary may not establish, under section 321(n), 341, or 343 of this title, maximum limits on the potency of any synthetic or natural vitamin or mineral within a food to which this section applies;
(B) the Secretary may not classify any natural or synthetic vitamin or mineral (or combination thereof) as a drug solely because it exceeds the level of potency which the Secretary determines is nutritionally rational or useful;
(C) the Secretary may not limit, under section 321(n), 341, or 343 of this title, the combination or number of any synthetic or natural—
(i) vitamin,
(ii) mineral, or
(iii) other ingredient of food,
within a food to which this section applies.
(2) Paragraph (1) shall not apply in the case of a vitamin, mineral, other ingredient of food, or food, which is represented for use by individuals in the treatment or management of specific diseases or disorders, by children, or by pregnant or lactating women. For purposes of this subparagraph,1
1 So in original. Probably should be “paragraph”.
the term “children” means individuals who are under the age of twelve years.(b) Labeling and advertising requirements for foods
(1) A food to which this section applies shall not be deemed under section 343 of this title to be misbranded solely because its label bears, in accordance with section 343(i)(2) of this title, all the ingredients in the food or its advertising contains references to ingredients in the food which are not vitamins or minerals.
(2) The labeling for any food to which this section applies may not list its ingredients which are not dietary supplement ingredients described in section 321(ff) of this title (i) except as a part of a list of all the ingredients of such food, and (ii) unless such ingredients are listed in accordance with applicable regulations under
(c) Definitions
(1) For purposes of this section, the term “food to which this section applies” means a food for humans which is a food for special dietary use—
(A) which is or contains any natural or synthetic vitamin or mineral, and
(B) which—
(i) is intended for ingestion in tablet, capsule, powder, softgel, gelcap, or liquid form, or
(ii) if not intended for ingestion in such a form, is not represented as conventional food and is not represented for use as a sole item of a meal or of the diet.
(2) For purposes of paragraph (1)(B)(i), a food shall be considered as intended for ingestion in liquid form only if it is formulated in a fluid carrier and it is intended for ingestion in daily quantities measured in drops or similar small units of measure.
(3) For purposes of paragraph (1) and of section 343(j) of this title insofar as that section is applicable to food to which this section applies, the term “special dietary use” as applied to food used by man means a particular use for which a food purports or is represented to be used, including but not limited to the following:
(A) Supplying a special dietary need that exists by reason of a physical, physiological, pathological, or other condition, including but not limited to the condition of disease, convalescence, pregnancy, lactation, infancy, allergic hypersensitivity to food, underweight, overweight, or the need to control the intake of sodium.
(B) Supplying a vitamin, mineral, or other ingredient for use by man to supplement his diet by increasing the total dietary intake.
(C) Supplying a special dietary need by reason of being a food for use as the sole item of the diet.
(June 25, 1938, ch. 675, § 411, as added Pub. L. 94–278, title V, § 501(a), Apr. 22, 1976, 90 Stat. 410; amended Pub. L. 103–417, §§ 3(c), 7(d), Oct. 25, 1994, 108 Stat. 4328, 4331.)
§ 350a. Infant formulas
(a) AdulterationAn infant formula, including an infant formula powder, shall be deemed to be adulterated if—
(1) such infant formula does not provide nutrients as required by subsection (i),
(2) such infant formula does not meet the quality factor requirements prescribed by the Secretary under subsection (b)(1), or
(3) the processing of such infant formula is not in compliance with the good manufacturing practices and the quality control procedures prescribed by the Secretary under subsection (b)(2).
(b) Requirements for quality factors, good manufacturing practices, and retention of records
(1) The Secretary shall by regulation establish requirements for quality factors for infant formulas to the extent possible consistent with current scientific knowledge, including quality factor requirements for the nutrients required by subsection (i).
(2)
(A) The Secretary shall by regulation establish good manufacturing practices for infant formulas, including quality control procedures that the Secretary determines are necessary to assure that an infant formula provides nutrients in accordance with this subsection and subsection (i) and is manufactured in a manner designed to prevent adulteration of the infant formula.
(B) The good manufacturing practices and quality control procedures prescribed by the Secretary under subparagraph (A) shall include requirements for—
(i) the testing, in accordance with paragraph (3) and by the manufacturer of an infant formula or an agent of such manufacturer, of each batch of infant formula for each nutrient required by subsection (i) before the distribution of such batch,
(ii) regularly scheduled testing, by the manufacturer of an infant formula or an agent of such manufacturer, of samples of infant formulas during the shelf life of such formulas to ensure that such formulas are in compliance with this section,
(iii) in-process controls including, where necessary, testing required by good manufacturing practices designed to prevent adulteration of each batch of infant formula, and
(iv) the conduct by the manufacturer of an infant formula or an agent of such manufacturer of regularly scheduled audits to determine that such manufacturer has complied with the regulations prescribed under subparagraph (A).
In prescribing requirements for audits under clause (iv), the Secretary shall provide that such audits be conducted by appropriately trained individuals who do not have any direct responsibility for the manufacture or production of infant formula.
(3)
(A) At the final product stage, each batch of infant formula shall be tested for vitamin A, vitamin B1, vitamin C, and vitamin E to ensure that such infant formula is in compliance with the requirements of this subsection and subsection (i) relating to such vitamins.
(B) Each nutrient premix used in the manufacture of an infant formula shall be tested for each relied upon nutrient required by subsection (i) which is contained in such premix to ensure that such premix is in compliance with its specifications or certifications by a premix supplier.
(C) During the manufacturing process or at the final product stage and before distribution of an infant formula, an infant formula shall be tested for all nutrients required to be included in such formula by subsection (i) for which testing has not been conducted pursuant to subparagraph (A) or (B). Testing under this subparagraph shall be conducted to—
(i) ensure that each batch of such infant formula is in compliance with the requirements of subsection (i) relating to such nutrients, and
(ii) confirm that nutrients contained in any nutrient premix used in such infant formula are present in each batch of such infant formula in the proper concentration.
(D) If the Secretary adds a nutrient to the list of nutrients in the table in subsection (i), the Secretary shall by regulation require that the manufacturer of an infant formula test each batch of such formula for such new nutrient in accordance with subparagraph (A), (B), or (C).
(E) For purposes of this paragraph, the term “final product stage” means the point in the manufacturing process, before distribution of an infant formula, at which an infant formula is homogenous and is not subject to further degradation.
(4)
(A) The Secretary shall by regulation establish requirements respecting the retention of records. Such requirements shall provide for—
(i) the retention of all records necessary to demonstrate compliance with the good manufacturing practices and quality control procedures prescribed by the Secretary under paragraph (2), including records containing the results of all testing required under paragraph (2)(B),
(ii) the retention of all certifications or guarantees of analysis by premix suppliers,
(iii) the retention by a premix supplier of all records necessary to confirm the accuracy of all premix certifications and guarantees of analysis,
(iv) the retention of—(I) all records pertaining to the microbiological quality and purity of raw materials used in infant formula powder and in finished infant formula, and(II) all records pertaining to food packaging materials which show that such materials do not cause an infant formula to be adulterated within the meaning of section 342(a)(2)(C) of this title,
(v) the retention of all records of the results of regularly scheduled audits conducted pursuant to the requirements prescribed by the Secretary under paragraph (2)(B)(iv), and
(vi) the retention of all complaints and the maintenance of files with respect to, and the review of, complaints concerning infant formulas which may reveal the possible existence of a hazard to health.
(B)
(i) Records required under subparagraph (A) with respect to an infant formula shall be retained for at least one year after the expiration of the shelf life of such infant formula. Except as provided in clause (ii), such records shall be made available to the Secretary for review and duplication upon request of the Secretary.
(ii) A manufacturer need only provide written assurances to the Secretary that the regularly scheduled audits required by paragraph (2)(B)(iv) are being conducted by the manufacturer, and need not make available to the Secretary the actual written reports of such audits.
(c) Registration of persons distributing new infant formula
(1) No person shall introduce or deliver for introduction into interstate commerce any new infant formula unless—
(A) such person has, before introducing such new infant formula, or delivering such new infant formula for introduction, into interstate commerce, registered with the Secretary the name of such person, the place of business of such person, and all establishments at which such person intends to manufacture such new infant formula, and
(B) such person has at least 90 days before marketing such new infant formula, made the submission to the Secretary required by subsection (d)(1).
(2) For purposes of paragraph (1), the term “new infant formula” includes—
(A) an infant formula manufactured by a person which has not previously manufactured an infant formula, and
(B) an infant formula manufactured by a person which has previously manufactured infant formula and in which there is a major change, in processing or formulation, from a current or any previous formulation produced by such manufacturer.
For purposes of this paragraph, the term “major change” has the meaning given to such term in section 106.30(c)(2) of title 21, Code of Federal Regulations (as in effect on August 1, 1986), and guidelines issued thereunder.
(d) Submission of information about new infant formula required
(1) A person shall, with respect to any infant formula subject to subsection (c), make a submission to the Secretary which shall include—
(A) the quantitative formulation of the infant formula,
(B) a description of any reformulation of the formula or change in processing of the infant formula,
(C) assurances that the infant formula will not be marketed unless it meets the requirements of subsections (b)(1) and (i), as demonstrated by the testing required under subsection (b)(3), and
(D) assurances that the processing of the infant formula complies with subsection (b)(2).
(2) After the first production of an infant formula subject to subsection (c), and before the introduction into interstate commerce of such formula, the manufacturer of such formula shall submit to the Secretary, in such form as may be prescribed by the Secretary, a written verification which summarizes test results and records demonstrating that such formula complies with the requirements of subsections (b)(1), (b)(2)(A), (b)(2)(B)(i), (b)(2)(B)(iii), (b)(3)(A), (b)(3)(C), and (i).
(3) If the manufacturer of an infant formula for commercial or charitable distribution for human consumption determines that a change in the formulation of the formula or a change in the processing of the formula may affect whether the formula is adulterated under subsection (a), the manufacturer shall, before the first processing of such formula, make the submission to the Secretary required by paragraph (1).
(4) The Secretary shall provide a response to a submission under this subsection not later than 45 days after receiving such submission.
(e) Additional notice requirements for manufacturer
(1) If the manufacturer of an infant formula has knowledge which reasonably supports the conclusion that an infant formula which has been processed by the manufacturer and which has left an establishment subject to the control of the manufacturer—
(A) may not provide the nutrients required by subsection (i), or
(B) may be otherwise adulterated or misbranded,
the manufacturer shall promptly notify the Secretary of such knowledge. If the Secretary determines that the infant formula presents a risk to human health, the manufacturer shall immediately take all actions necessary to recall shipments of such infant formula from all wholesale and retail establishments, consistent with recall regulations and guidelines issued by the Secretary.
(2) For purposes of paragraph (1), the term “knowledge” as applied to a manufacturer means (A) the actual knowledge that the manufacturer had, or (B) the knowledge which a reasonable person would have had under like circumstances or which would have been obtained upon the exercise of due care.
(f) Procedures applicable to recalls by manufacturer; regulatory oversight
(1) If a recall of infant formula is begun by a manufacturer, the recall shall be carried out in accordance with such requirements as the Secretary shall prescribe under paragraph (2) and—
(A) the Secretary shall, not later than the 15th day after the beginning of such recall and at least once every 15 days thereafter until the recall is terminated, review the actions taken under the recall to determine whether the recall meets the requirements prescribed under paragraph (2), and
(B) the manufacturer shall, not later than the 14th day after the beginning of such recall and at least once every 14 days thereafter until the recall is terminated, report to the Secretary the actions taken to implement the recall.
(2) The Secretary shall by regulation prescribe the scope and extent of recalls of infant formulas necessary and appropriate for the degree of risks to human health presented by the formula subject to the recall.
(3) The Secretary shall by regulation require each manufacturer of an infant formula who begins a recall of such formula because of a risk to human health to request each retail establishment at which such formula is sold or available for sale to post at the point of purchase of such formula a notice of such recall at such establishment for such time that the Secretary determines necessary to inform the public of such recall.
(g) Recordkeeping requirements for manufacturer; regulatory oversight and enforcement
(1) Each manufacturer of an infant formula shall make and retain such records respecting the distribution of the infant formula through any establishment owned or operated by such manufacturer as may be necessary to effect and monitor recalls of the formula. Such records shall be retained for at least one year after the expiration of the shelf life of the infant formula.
(2) To the extent that the Secretary determines that records are not being made or maintained in accordance with paragraph (1), the Secretary may by regulation prescribe the records required to be made under paragraph (1) and requirements respecting the retention of such records under such paragraph. Such regulations shall take effect on such date as the Secretary prescribes but not sooner than the 180th day after the date such regulations are promulgated. Such regulations shall apply only with respect to distributions of infant formulas made after such effective date.
(h) Exemptions; regulatory oversight
(1) Any infant formula which is represented and labeled for use by an infant—
(A) who has an inborn error of metabolism or a low birth weight, or
(B) who otherwise has an unusual medical or dietary problem,
is exempt from the requirements of subsections (a), (b), and (c). The manufacturer of an infant formula exempt under this paragraph shall, in the case of the exempt formula, be required to provide the notice required by subsection (e)(1) only with respect to adulteration or misbranding described in subsection (e)(1)(B) and to comply with the regulations prescribed by the Secretary under paragraph (2).
(2) The Secretary may by regulation establish terms and conditions for the exemption of an infant formula from the requirements of subsections (a), (b), and (c). An exemption of an infant formula under paragraph (1) may be withdrawn by the Secretary if such formula is not in compliance with applicable terms and conditions prescribed under this paragraph.
(i) Nutrient requirements
(1) An infant formula shall contain nutrients in accordance with the table set out in this subsection, which shall be reviewed by the Secretary every 4 years as appropriate. In reviewing such table, the Secretary shall consider any new scientific data or information related to infant formula nutrients, including international infant formula standards. The Secretary may revise the list of nutrients and the required level for any nutrient required by the table.
(2) The Secretary may by regulation—
(A) revise the list of nutrients in the table in this subsection, and
(B) revise the required level for any nutrient required by the table.
NUTRIENTS | Nutrient | Minimum a | Maximum a | b The source of protein shall be at least nutritionally equivalent to casein. | d Required to be included in this amount only in formulas which are not milk-based. | e Calcium to phosphorus ratio must be no less than 1.1 nor more than 2.0. | Protein (gm) | 1.8 b | 4.5. | Fat: | gm | 3.3 | 6.0. | percent cal | 30.0 | 54.0. | Essential fatty acids (linoleate): | percent cal | 2.7 | mg | 300.0 | Vitamins: | A (IU) | 250.0 | (75 μg)c | 750.0 (225 μg).c | D (IU) | 40.0 | 100.0. | K (μg) | 4.0 | E (IU) | 0.7 | (with 0.7 IU/gm linoleic acid) | C (ascorbic acid) (mg) | 8.0 | B1 (thiamine) (μg) | 40.0 | B2 (riboflavin) (μg) | 60.0 | B6 (pyridoxine) (μg) | 35.0 | (with 15 μg/gm of protein in formula) | B12 (μg) | 0.15 | Niacin (μg) | 250.0 | Folic acid (μg) | 4.0 | Pantothenic acid (μg) | 300.0 | Biotin (μg) | 1.5 d | Choline (mg) | 7.0 d | Inositol (mg) | 4.0 d | Minerals: | Calcium (mg) | 50.0 e | Phosphorus (mg) | 25.0 e | Magnesium (mg) | 6.0 | Iron (mg) | 0.15 | Iodine (μg) | 5.0 | Zinc (mg) | 0.5 | Copper (μg) | 60.0 | Manganese (μg) | 5.0 | Sodium (mg) | 20.0 | 60.0. | Potassium (mg) | 80.0 | 200.0. | Chloride (mg) | 55.0 | 150.0. |
|---|
(j) Premarket submissions to address shortages
(1) In general
(2) Effective periodThe waiver authority under this subsection shall remain in effect—
(A) for 90 days beginning on the date that the Secretary distributes information under section 350m(a)(2) of this title with respect to a shortage of infant formula; or
(B) such longer period as the Secretary determines appropriate, to prevent or mitigate a shortage of infant formula.
(k) Congressional notification of recall
(1) In general
(2) ContentsA notification under paragraph (1) shall include the following:
(A) If the recall is required by the Food and Drug Administration, a summary of the information supporting a determination that the adulterated or misbranded infant formula presents a risk to human health.
(B) If the recall is voluntarily initiated by the manufacturer, a summary of the information provided to the Food and Drug Administration by the manufacturer regarding infant formula that has left the control of the manufacturer that may be adulterated or misbranded.
(C) Specification of when the Food and Drug Administration was first made aware of the instance or circumstances surrounding the recall.
(D) An initial estimate of the disruption in domestic production that may result from the recall.
(l) Annual report to Congress
(1) In generalNot later than March 30 of each year, the Secretary shall submit a report to Congress containing, with respect to the preceding calendar year, the following information:
(A) The number of submissions received by the Secretary under subsection (d).
(B) The number of such submissions that included any new ingredients that were not included in any infant formula already on the market.
(C) The number of inspections conducted by the Food and Drug Administration or any agent thereof to evaluate compliance with the requirements for infant formulas under subsection (b).
(D) The time between any inspection referred to in subparagraph (C) and any necessary reinspection to evaluate compliance with the requirements for infant formulas under subsection (b).
(E) A breakdown of the information described in subparagraphs (A) through (D) between foreign and domestic manufacturers and facilities.
(2) Confidentiality
(m) Waiver of requirements for importation of specialty infant formula
(1) In generalThe Secretary may, during a shortage of specialty infant formula as determined by the Secretary, waive any requirement under this chapter applicable to facilitate the importation of specialty infant formula. Such a waiver may be applicable to—
(A) the importation of specialty infant formula from any country that is determined by the Secretary to be implementing and enforcing requirements for infant formula that provide a similar assurance of safety and nutritional adequacy as the requirements of this chapter; or
(B) the distribution and sale of such imported specialty infant formula.
(2) Rule of construction
(3) Definition of specialty infant formula
(June 25, 1938, ch. 675, § 412, as added Pub. L. 96–359, § 2, Sept. 26, 1980, 94 Stat. 1190; amended Pub. L. 99–570, title IV, § 4014(a), (b)(1), Oct. 27, 1986, 100 Stat. 3207–116, 3207–120; Pub. L. 103–80, § 3(l), Aug. 13, 1993, 107 Stat. 777; Pub. L. 117–328, div. FF, title III, § 3401(c), (g)(1)–(4), (6), (l), Dec. 29, 2022, 136 Stat. 5838, 5840, 5841, 5845.)
§ 350a–1. Protecting infants and improving formula supply
(a) Definitions
(1) In general
(2) Omitted
(b) Office of Critical Foods
(1) In general
(2) Duties
(c) Omitted
(d) ReportNot later than one year after December 29, 2022, the Secretary shall submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives that includes—
(1) the number of premarket submissions for new infant formula the Secretary has received under section 412(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(d)) each year since 2012;
(2) how many of such submissions received requests from the Secretary for additional information;
(3) how long after receiving such submissions the Secretary sent such requests for additional information;
(4) what additional information the Secretary requested of the persons submitting such submissions; and
(5) the date each new infant formula described in subparagraph (A) 1
1 So in original. There is no subparagraph (A).
was first marketed, if available.(e) Infant formula flexibilities
(f) International harmonization of infant formula requirements
(1) In generalThe Secretary—
(A) shall participate in meetings with representatives from other countries to discuss methods and approaches to harmonizing regulatory requirements for infant formula, including with respect to inspections, labeling, and nutritional requirements; and
(B) may enter into arrangements or agreements regarding such requirements with other countries, as appropriate, including arrangements or agreements with a foreign government or agency of a foreign government to recognize the inspection of foreign establishments that manufacture infant formula for export to the United States.
(2) Study on infant formula
(A) In general
(B) Contents of the reportThe report developed pursuant to the agreement under subparagraph (A) shall—
(i) assess and evaluate—(I) infant formula marketed in the United States;(II) any challenges in supply, or market competition with respect to such infant formula; and(III) any differences between infant formula marketed in the United States and infant formula marketed in the European Union, including with respect to nutritional span and applicable labeling and other regulatory requirements; and
(ii) include recommendations, including for infant formula manufacturers, on measures to address supply and market competition in the United States.
(C) Final report
(g) Transparency and accountability to support infant formula innovation
(1) to (4) Omitted
(5) Guidance
(6) Omitted
(h) Response to recall
(1) Manufacturer submission
(A) In general
(B) ContentsA submission under subparagraph (A) shall include the following:
(i) A plan (including an estimated timeline, as applicable) of actions the manufacturer will take, suited to the individual circumstances of the particular recall, including—(I) to identify and address any cause of, and contributing factor in, known or suspected adulteration or known or suspected misbranding; and(II) if appropriate, to restore operation of the impacted facilities.
(ii) In the case that a recall of the manufacturer’s infant formula products, and subsequent actions to respond to such recall, impacts over 10 percent of the production of the infant formula intended for sale in the United States, a plan to backfill the supply of the manufacturer’s infant formula supply if the current domestic supply of such infant formula has fallen, or is expected to fall, below the expected demand for the formula.
(2) Report to Congress
(A) In general
(B) ContentsA report under subparagraph (A) shall include the following:
(i) Information concerning the current domestic supply of infant formula, including—(I) a breakdown of the specific types of formula involved; and(II) an estimate of how long current supplies will last.
(ii) If a submission or submissions under paragraph (1) show that the recall and subsequent actions to respond to the recall impact over 10 percent of the domestic production of infant formula intended for sale in the United States—(I) actions to work with the impacted manufacturer or other manufacturers to increase production; and(II) specification of—(aa) any additional authorities needed regarding production or importation to fill a supply gap; and(bb) any supplemental funding necessary to address the shortage.
(3) Sunset
(i) Coordination with manufacturer
(1) In general
(A) Communication following inspectionUpon completing an inspection of an infant formula manufacturing facility impacted by a recall, the Secretary, acting through the Commissioner of Food and Drugs, shall provide the manufacturer involved a list of any actions necessary to—
(i) address deficiencies contributing to the potential adulteration or misbranding of product at the facility; and
(ii) safely restart production at the facility.
(B) Response to manufacturer
(2) Inspections
(3) Annual inspections
(j) National strategy on infant formula
(1) In general
(2) Immediate national strategyThe national strategy under paragraph (1) shall include efforts—
(A) to increase the resiliency of the infant formula supply chain in the short-term by—
(i) assessing causes of any supply disruption or shortage of infant formula in existence as of December 29, 2022, and potential causes of future supply disruptions and shortages;
(ii) assessing and addressing immediate infant formula needs associated with the shortage; and
(iii) developing a plan to increase infant formula supply, including through increased competition; and
(B) to ensure the development and updating of education and communication materials for parents and caregivers that cover—
(i) where and how to find infant formula;
(ii) comparable infant formulas on the market;
(iii) what to do if a specialty infant formula is unavailable;
(iv) safe practices for handling infant formula; and
(v) other topics, as appropriate.
(3) Long-term strategyNot later than 90 days after the submission of the report described in subsection (f)(2), the Secretary shall update the national strategy under paragraph (1) to include efforts to improve preparedness against infant formula shortages in the long-term by—
(A) outlining methods to improve information-sharing between the Federal Government and State and local governments, and other entities as appropriate, regarding shortages;
(B) recommending measures for protecting the integrity of the infant formula supply and preventing contamination;
(C) outlining methods to incentivize new infant formula manufacturers to increase supply and mitigate future shortages; and
(D) recommending other necessary authorities to gain insight into the supply chain and risk for shortages, and to incentivize new infant formula manufacturers.
(k), (l) Omitted
(m) Importation for personal use
(1) In generalNotwithstanding any provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), during the 90-day period beginning on December 29, 2022, an individual may, without prior notice to the Food and Drug Administration, import up to a 3-month supply of infant formula for personal use from—
(A) Canada;
(B) any country in the European Union; or
(C) any other country that is determined by the Secretary to be implementing and enforcing requirements for infant formula that provide a similar assurance of safety and nutritional adequacy as the requirements of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
(2) LimitationsInfant formula may be imported pursuant to paragraph (1) only if the infant formula—
(A) is exclusively for personal use and will not be commercialized or promoted; and
(B) does not present an unreasonable risk to human health.
(3) Reporting of adverse events
(4) Public noticeThe Secretary, acting through the Commissioner of Food and Drugs, shall post on the public website of the Food and Drug Administration notice that—
(A) infant formula imported pursuant to paragraph (1) may not have been manufactured in a facility that has been inspected by the Food and Drug Administration;
(B) the labeling of such infant formula may not meet the standards and other requirements applicable with respect to infant formula under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.); and
(C) the nutritional span of infant formula imported pursuant to paragraph (1) may vary from that of infant formula meeting such standards and other requirements.
(5) Sense of Congress
(Pub. L. 117–328, div. FF, title III, § 3401, Dec. 29, 2022, 136 Stat. 5838.)
§ 350b. New dietary ingredients
(a) In general
A dietary supplement which contains a new dietary ingredient shall be deemed adulterated under section 342(f) of this title unless it meets one of the following requirements:
(1) The dietary supplement contains only dietary ingredients which have been present in the food supply as an article used for food in a form in which the food has not been chemically altered.
(2) There is a history of use or other evidence of safety establishing that the dietary ingredient when used under the conditions recommended or suggested in the labeling of the dietary supplement will reasonably be expected to be safe and, at least 75 days before being introduced or delivered for introduction into interstate commerce, the manufacturer or distributor of the dietary ingredient or dietary supplement provides the Secretary with information, including any citation to published articles, which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe.
The Secretary shall keep confidential any information provided under paragraph (2) for 90 days following its receipt. After the expiration of such 90 days, the Secretary shall place such information on public display, except matters in the information which are trade secrets or otherwise confidential, commercial information.
(b) Petition
(c) Notification
(1) In general
(2) Definitions
For purposes of this subsection—
(A) the term “anabolic steroid” has the meaning given such term in section 802(41) of this title; and
(B) the term “analogue of an anabolic steroid” means a substance whose chemical structure is substantially similar to the chemical structure of an anabolic steroid.
(d) “New dietary ingredient” defined
(June 25, 1938, ch. 675, § 413, as added Pub. L. 103–417, § 8, Oct. 25, 1994, 108 Stat. 4331; amended Pub. L. 111–353, title I, § 113(a), Jan. 4, 2011, 124 Stat. 3920.)
§ 350c. Maintenance and inspection of records
(a) Records inspection
(1) Adulterated food
(2) Use of or exposure to food of concern
(3) Application
(b) Regulations concerning recordkeeping
(c) Protection of sensitive information
(d) Limitations
This section shall not be construed—
(1) to limit the authority of the Secretary to inspect records or to require establishment and maintenance of records under any other provision of this chapter;
(2) to authorize the Secretary to impose any requirements with respect to a food to the extent that it is within the exclusive jurisdiction of the Secretary of Agriculture pursuant to the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg Products Inspection Act (21 U.S.C. 1031 et seq.);
(3) to have any legal effect on section 552 of title 5 or section 1905 of title 18; or
(4) to extend to recipes for food, financial data, pricing data, personnel data, research data, or sales data (other than shipment data regarding sales).
(June 25, 1938, ch. 675, § 414, as added Pub. L. 107–188, title III, § 306(a), June 12, 2002, 116 Stat. 669; amended Pub. L. 111–353, title I, § 101(a), Jan. 4, 2011, 124 Stat. 3886.)
§ 350d. Registration of food facilities
(a) Registration
(1) In general
The Secretary shall by regulation require that any facility engaged in manufacturing, processing, packing, or holding food for consumption in the United States be registered with the Secretary. To be registered—
(A) for a domestic facility, the owner, operator, or agent in charge of the facility shall submit a registration to the Secretary; and
(B) for a foreign facility, the owner, operator, or agent in charge of the facility shall submit a registration to the Secretary and shall include with the registration the name of the United States agent for the facility.
(2) Registration
(3) Biennial registration renewal
(4) Procedure
(5) List
(b) Suspension of registration
(1) In general
If the Secretary determines that food manufactured, processed, packed, received, or held by a facility registered under this section has a reasonable probability of causing serious adverse health consequences or death to humans or animals, the Secretary may by order suspend the registration of a facility—
(A) that created, caused, or was otherwise responsible for such reasonable probability; or
(B)
(i) that knew of, or had reason to know of, such reasonable probability; and
(ii) packed, received, or held such food.
(2) Hearing on suspension
(3) Post-hearing corrective action plan; vacating of order
(A) Corrective action plan
(B) Vacating of order
(4) Effect of suspension
(5) Regulations
(A) In general
(B) Registration requirement
(6) Application date
Facilities shall be subject to the requirements of this subsection beginning on the earlier of—
(A) the date on which the Secretary issues regulations under paragraph (5); or
(B) 180 days after January 4, 2011.
(7) No delegation
(c) Facility
For purposes of this section:
(1) The term “facility” includes any factory, warehouse, or establishment (including a factory, warehouse, or establishment of an importer) that manufactures, processes, packs, or holds food. Such term does not include farms; restaurants; other retail food establishments; nonprofit food establishments in which food is prepared for or served directly to the consumer; or fishing vessels (except such vessels engaged in processing as defined in section 123.3(k) of title 21, Code of Federal Regulations).
(2) The term “domestic facility” means a facility located in any of the States or Territories.
(3)
(A) The term “foreign facility” means a facility that manufacturers,1
1 So in original. Probably should be “manufactures,”.
processes, packs, or holds food, but only if food from such facility is exported to the United States without further processing or packaging outside the United States.(B) A food may not be considered to have undergone further processing or packaging for purposes of subparagraph (A) solely on the basis that labeling was added or that any similar activity of a de minimis nature was carried out with respect to the food.
(d) Rule of construction
(June 25, 1938, ch. 675, § 415, as added Pub. L. 107–188, title III, § 305(a), June 12, 2002, 116 Stat. 667; amended Pub. L. 111–353, title I, § 102(a)–(b)(1), (d)(2), Jan. 4, 2011, 124 Stat. 3887, 3889.)
§ 350e. Sanitary transportation practices
(a) DefinitionsIn this section:
(1) Bulk vehicle
(2) Transportation
(b) Regulations
(c) ContentsThe regulations under subsection (b) shall—
(1) prescribe such practices as the Secretary determines to be appropriate relating to—
(A) sanitation;
(B) packaging, isolation, and other protective measures;
(C) limitations on the use of vehicles;
(D) information to be disclosed—
(i) to a carrier by a person arranging for the transport of food; and
(ii) to a manufacturer or other person that—(I) arranges for the transportation of food by a carrier; or(II) furnishes a tank vehicle or bulk vehicle for the transportation of food; and
(E) recordkeeping; and
(2) include—
(A) a list of nonfood products that the Secretary determines may, if shipped in a bulk vehicle, render adulterated food that is subsequently transported in the same vehicle; and
(B) a list of nonfood products that the Secretary determines may, if shipped in a motor vehicle or rail vehicle (other than a tank vehicle or bulk vehicle), render adulterated food that is simultaneously or subsequently transported in the same vehicle.
(d) Waivers
(1) In generalThe Secretary may waive any requirement under this section, with respect to any class of persons, vehicles, food, or nonfood products, if the Secretary determines that the waiver—
(A) will not result in the transportation of food under conditions that would be unsafe for human or animal health; and
(B) will not be contrary to the public interest.
(2) Publication
(e) Preemption
(1) In generalA requirement of a State or political subdivision of a State that concerns the transportation of food is preempted if—
(A) complying with a requirement of the State or political subdivision and a requirement of this section, or a regulation prescribed under this section, is not possible; or
(B) the requirement of the State or political subdivision as applied or enforced is an obstacle to accomplishing and carrying out this section or a regulation prescribed under this section.
(2) Applicability
(f) Assistance of other agencies
(June 25, 1938, ch. 675, § 416, as added Pub. L. 109–59, title VII, § 7202(b), Aug. 10, 2005, 119 Stat. 1911.)
§ 350f. Reportable food registry
(a) DefinitionsIn this section:
(1) Responsible party
(2) Reportable food
(b) Establishment
(1) In generalNot later than 1 year after September 27, 2007, the Secretary shall establish within the Food and Drug Administration a Reportable Food Registry to which instances of reportable food may be submitted by the Food and Drug Administration after receipt of reports under subsection (d), via an electronic portal, from—
(A) Federal, State, and local public health officials; or
(B) responsible parties.
(2) Review by Secretary
(c) Issuance of an alert by the Secretary
(1) In general
(2) Effect
(d) Reporting and notification
(1) In generalExcept as provided in paragraph (2), as soon as practicable, but in no case later than 24 hours after a responsible party determines that an article of food is a reportable food, the responsible party shall—
(A) submit a report to the Food and Drug Administration through the electronic portal established under subsection (b) that includes the data elements described in subsection (e) (except the elements described in paragraphs (8), (9), and (10) of such subsection); and
(B) investigate the cause of the adulteration if the adulteration of the article of food may have originated with the responsible party.
(2) No report requiredA responsible party is not required to submit a report under paragraph (1) if—
(A) the adulteration originated with the responsible party;
(B) the responsible party detected the adulteration prior to any transfer to another person of such article of food; and
(C) the responsible party—
(i) corrected such adulteration; or
(ii) destroyed or caused the destruction of such article of food.
(3) Reports by public health officials
(4) Report number
(5) Review
(6) Response to report submitted by a responsible partyAfter consultation with the responsible party that submitted a report under paragraph (1), the Secretary may require such responsible party to perform, as soon as practicable, but in no case later than a time specified by the Secretary, 1 or more of the following:
(A) Amend the report submitted by the responsible party under paragraph (1) to include the data element described in subsection (e)(9).
(B) Provide a notification—
(i) to the immediate previous source of the article of food, if the Secretary deems necessary;
(ii) to the immediate subsequent recipient of the article of food, if the Secretary deems necessary; and
(iii) that includes—(I) the data elements described in subsection (e) that the Secretary deems necessary;(II) the actions described under paragraph (7) that the recipient of the notification shall perform, as required by the Secretary; and(III) any other information that the Secretary may require.
(7) Subsequent reports and notificationsExcept as provided in paragraph (8), the Secretary may require a responsible party to perform, as soon as practicable, but in no case later than a time specified by the Secretary, after the responsible party receives a notification under subparagraph (C) or paragraph (6)(B), 1 or more of the following:
(A) Submit a report to the Food and Drug Administration through the electronic portal established under subsection (b) that includes those data elements described in subsection (e) and other information that the Secretary deems necessary.
(B) Investigate the cause of the adulteration if the adulteration of the article of food may have originated with the responsible party.
(C) Provide a notification—
(i) to the immediate previous source of the article of food, if the Secretary deems necessary;
(ii) to the immediate subsequent recipient of the article of food, if the Secretary deems necessary; and
(iii) that includes—(I) the data elements described in subsection (e) that the Secretary deems necessary;(II) the actions described under this paragraph that the recipient of the notification shall perform, as required by the Secretary; and(III) any other information that the Secretary may require.
(8) Amended reportIf a responsible party receives a notification under paragraph (6)(B) or paragraph (7)(C) with respect to an article of food after the responsible party has submitted a report to the Food and Drug Administration under paragraph (1) with respect to such article of food—
(A) the responsible party is not required to submit an additional report or make a notification under paragraph (7); and
(B) the responsible party shall amend the report submitted by the responsible party under paragraph (1) to include the data elements described in paragraph (9), and, with respect to both such notification and such report, paragraph (11) of subsection (e).
(e) Data elementsThe data elements described in this subsection are the following:
(1) The registration numbers of the responsible party under section 350d(a)(3) 1
1 See References in Text note below.
of this title.(2) The date on which an article of food was determined to be a reportable food.
(3) A description of the article of food including the quantity or amount.
(4) The extent and nature of the adulteration.
(5) If the adulteration of the article of food may have originated with the responsible party, the results of the investigation required under paragraph (1)(B) or (7)(B) of subsection (d), as applicable and when known.
(6) The disposition of the article of food, when known.
(7) Product information typically found on packaging including product codes, use-by dates, and names of manufacturers, packers, or distributors sufficient to identify the article of food.
(8) Contact information for the responsible party.
(9) The contact information for parties directly linked in the supply chain and notified under paragraph (6)(B) or (7)(C) of subsection (d), as applicable.
(10) The information required by the Secretary to be included in a notification provided by the responsible party involved under paragraph (6)(B) or (7)(C) of subsection (d) or required in a report under subsection (d)(7)(A).
(11) The unique number described in subsection (d)(4).
(f) Critical informationExcept with respect to fruits and vegetables that are raw agricultural commodities, not more than 18 months after January 4, 2011, the Secretary may require a responsible party to submit to the Secretary consumer-oriented information regarding a reportable food, which shall include—
(1) a description of the article of food as provided in subsection (e)(3);
(2) as provided in subsection (e)(7), affected product identification codes, such as UPC, SKU, or lot or batch numbers sufficient for the consumer to identify the article of food;
(3) contact information for the responsible party as provided in subsection (e)(8); and
(4) any other information the Secretary determines is necessary to enable a consumer to accurately identify whether such consumer is in possession of the reportable food.
(g) Grocery store notification
(1) Action by SecretaryThe Secretary shall—
(A) prepare the critical information described under subsection (f) for a reportable food as a standardized one-page summary;
(B) publish such one-page summary on the Internet website of the Food and Drug Administration in a format that can be easily printed by a grocery store for purposes of consumer notification.
(2) Action by grocery store
(h) Consumer notification
(1) In general
(2) List of conspicuous locationsNot more than 1 year after January 4, 2011, the Secretary shall develop and publish a list of acceptable conspicuous locations and manners, from which grocery stores shall select at least one, for providing the notification required in paragraph (1). Such list shall include—
(A) posting the notification at or near the register;
(B) providing the location of the reportable food;
(C) providing targeted recall information given to customers upon purchase of a food; and
(D) other such prominent and conspicuous locations and manners utilized by grocery stores as of January 4, 2011, to provide notice of such recalls to consumers as considered appropriate by the Secretary.
(i) Coordination of Federal, State, and local efforts
(1) Department of AgricultureIn implementing this section, the Secretary shall—
(A) share information and coordinate regulatory efforts with the Department of Agriculture; and
(B) if the Secretary receives a report submitted about a food within the jurisdiction of the Department of Agriculture, promptly provide such report to the Department of Agriculture.
(2) States and localitiesIn implementing this section, the Secretary shall work with the State and local public health officials to share information and coordinate regulatory efforts, in order to—
(A) help to ensure coverage of the safety of the food supply chain, including those food establishments regulated by the States and localities that are not required to register under section 350d of this title; and
(B) reduce duplicative regulatory efforts.
(j) Maintenance and inspection of records
(k) Request for information
(l) Safety report
(m) Admission
(n) Homeland Security notification
(June 25, 1938, ch. 675, § 417, as added Pub. L. 110–85, title X, § 1005(b), Sept. 27, 2007, 121 Stat. 965; amended Pub. L. 111–353, title II, § 211(a), Jan. 4, 2011, 124 Stat. 3951.)
§ 350g. Hazard analysis and risk-based preventive controls
(a) In general
(b) Hazard analysisThe owner, operator, or agent in charge of a facility shall—
(1) identify and evaluate known or reasonably foreseeable hazards that may be associated with the facility, including—
(A) biological, chemical, physical, and radiological hazards, natural toxins, pesticides, drug residues, decomposition, parasites, allergens, and unapproved food and color additives; and
(B) hazards that occur naturally, or may be unintentionally introduced; and
(2) identify and evaluate hazards that may be intentionally introduced, including by acts of terrorism; and
(3) develop a written analysis of the hazards.
(c) Preventive controlsThe owner, operator, or agent in charge of a facility shall identify and implement preventive controls, including at critical control points, if any, to provide assurances that—
(1) hazards identified in the hazard analysis conducted under subsection (b)(1) will be significantly minimized or prevented;
(2) any hazards identified in the hazard analysis conducted under subsection (b)(2) will be significantly minimized or prevented and addressed, consistent with section 350i of this title, as applicable; and
(3) the food manufactured, processed, packed, or held by such facility will not be adulterated under section 342 of this title or misbranded under section 343(w) of this title.
(d) Monitoring of effectiveness
(e) Corrective actions
(1) appropriate action is taken to reduce the likelihood of recurrence of the implementation failure;
(2) all affected food is evaluated for safety; and
(3) all affected food is prevented from entering into commerce if the owner, operator or agent in charge of such facility cannot ensure that the affected food is not adulterated under section 342 of this title or misbranded under section 343(w) of this title.
(f) VerificationThe owner, operator, or agent in charge of a facility shall verify that—
(1) the preventive controls implemented under subsection (c) are adequate to control the hazards identified under subsection (b);
(2) the owner, operator, or agent is conducting monitoring in accordance with subsection (d);
(3) the owner, operator, or agent is making appropriate decisions about corrective actions taken under subsection (e);
(4) the preventive controls implemented under subsection (c) are effectively and significantly minimizing or preventing the occurrence of identified hazards, including through the use of environmental and product testing programs and other appropriate means; and
(5) there is documented, periodic reanalysis of the plan under subsection (i) to ensure that the plan is still relevant to the raw materials, conditions and processes in the facility, and new and emerging threats.
(g) Recordkeeping
(h) Written plan and documentation
(i) Requirement to reanalyze
(j) Exemption for seafood, juice, and low-acid canned food facilities subject to HACCP
(1) In generalThis section shall not apply to a facility if the owner, operator, or agent in charge of such facility is required to comply with, and is in compliance with, 1 of the following standards and regulations with respect to such facility:
(A) The Seafood Hazard Analysis Critical Control Points Program of the Food and Drug Administration.
(B) The Juice Hazard Analysis Critical Control Points Program of the Food and Drug Administration.
(C) The Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers standards of the Food and Drug Administration (or any successor standards).
(2) Applicability
(k) Exception for activities of facilities subject to section 350h of this title
(l) Modified requirements for qualified facilities
(1) Qualified facilities
(A) In general
(B) Very small businessA facility is a qualified facility under this subparagraph—
(i) if the facility, including any subsidiary or affiliate of the facility, is, collectively, a very small business (as defined in the regulations promulgated under subsection (n)); and
(ii) in the case where the facility is a subsidiary or affiliate of an entity, if such subsidiaries or affiliates, are, collectively, a very small business (as so defined).
(C) Limited annual monetary value of sales
(i) In generalA facility is a qualified facility under this subparagraph if clause (ii) applies—(I) to the facility, including any subsidiary or affiliate of the facility, collectively; and(II) to the subsidiaries or affiliates, collectively, of any entity of which the facility is a subsidiary or affiliate.
(ii) Average annual monetary valueThis clause applies if—(I) during the 3-year period preceding the applicable calendar year, the average annual monetary value of the food manufactured, processed, packed, or held at such facility (or the collective average annual monetary value of such food at any subsidiary or affiliate, as described in clause (i)) that is sold directly to qualified end-users during such period exceeded the average annual monetary value of the food manufactured, processed, packed, or held at such facility (or the collective average annual monetary value of such food at any subsidiary or affiliate, as so described) sold by such facility (or collectively by any such subsidiary or affiliate) to all other purchasers during such period; and(II) the average annual monetary value of all food sold by such facility (or the collective average annual monetary value of such food sold by any subsidiary or affiliate, as described in clause (i)) during such period was less than $500,000, adjusted for inflation.
(2) ExemptionA qualified facility—
(A) shall not be subject to the requirements under subsections (a) through (i) and subsection (n) in an applicable calendar year; and
(B) shall submit to the Secretary—
(i)(I) documentation that demonstrates that the owner, operator, or agent in charge of the facility has identified potential hazards associated with the food being produced, is implementing preventive controls to address the hazards, and is monitoring the preventive controls to ensure that such controls are effective; or(II) documentation (which may include licenses, inspection reports, certificates, permits, credentials, certification by an appropriate agency (such as a State department of agriculture), or other evidence of oversight), as specified by the Secretary, that the facility is in compliance with State, local, county, or other applicable non-Federal food safety law; and
(ii) documentation, as specified by the Secretary in a guidance document issued not later than 1 year after January 4, 2011, that the facility is a qualified facility under paragraph (1)(B) or (1)(C).
(3) Withdrawal; rule of construction
(A) In general
(B) Rule of construction
(4) DefinitionsIn this subsection:
(A) Affiliate
(B) Qualified end-userThe term “qualified end-user”, with respect to a food, means—
(i) the consumer of the food; or
(ii) a restaurant or retail food establishment (as those terms are defined by the Secretary for purposes of section 350d of this title) that—(I) is located—(aa) in the same State as the qualified facility that sold the food to such restaurant or establishment; or(bb) not more than 275 miles from such facility; and(II) is purchasing the food for sale directly to consumers at such restaurant or retail food establishment.
(C) Consumer
(D) Subsidiary
(5) Study
(A) In generalThe Secretary, in consultation with the Secretary of Agriculture, shall conduct a study of the food processing sector regulated by the Secretary to determine—
(i) the distribution of food production by type and size of operation, including monetary value of food sold;
(ii) the proportion of food produced by each type and size of operation;
(iii) the number and types of food facilities co-located on farms, including the number and proportion by commodity and by manufacturing or processing activity;
(iv) the incidence of foodborne illness originating from each size and type of operation and the type of food facilities for which no reported or known hazard exists; and
(v) the effect on foodborne illness risk associated with commingling, processing, transporting, and storing food and raw agricultural commodities, including differences in risk based on the scale and duration of such activities.
(B) Size
(C) Submission of report
(6) No preemption
(7) Notification to consumers
(A) In generalA qualified facility that is exempt from the requirements under subsections (a) through (i) and subsection (n) and does not prepare documentation under paragraph (2)(B)(i)(I) shall—
(i) with respect to a food for which a food packaging label is required by the Secretary under any other provision of this chapter, include prominently and conspicuously on such label the name and business address of the facility where the food was manufactured or processed; or
(ii) with respect to a food for which a food packaging label is not required by the Secretary under any other provisions of this chapter, prominently and conspicuously display, at the point of purchase, the name and business address of the facility where the food was manufactured or processed, on a label, poster, sign, placard, or documents delivered contemporaneously with the food in the normal course of business, or, in the case of Internet sales, in an electronic notice.
(B) No additional label
(m) Authority with respect to certain facilities
(n) Regulations
(1) In generalNot later than 18 months after January 4, 2011, the Secretary shall promulgate regulations—
(A) to establish science-based minimum standards for conducting a hazard analysis, documenting hazards, implementing preventive controls, and documenting the implementation of the preventive controls under this section; and
(B) to define, for purposes of this section, the terms “small business” and “very small business”, taking into consideration the study described in subsection (l)(5).
(2) Coordination
(3) ContentThe regulations promulgated under paragraph (1)(A) shall—
(A) provide sufficient flexibility to be practicable for all sizes and types of facilities, including small businesses such as a small food processing facility co-located on a farm;
(B) comply with chapter 35 of title 44 (commonly known as the “Paperwork Reduction Act”), with special attention to minimizing the burden (as defined in section 3502(2) of such title) on the facility, and collection of information (as defined in section 3502(3) of such title), associated with such regulations;
(C) acknowledge differences in risk and minimize, as appropriate, the number of separate standards that apply to separate foods; and
(D) not require a facility to hire a consultant or other third party to identify, implement, certify, or audit preventative controls, except in the case of negotiated enforcement resolutions that may require such a consultant or third party.
(4) Rule of construction
(5) Review
(o) DefinitionsFor purposes of this section:
(1) Critical control point
(2) Facility
(3) Preventive controlsThe term “preventive controls” means those risk-based, reasonably appropriate procedures, practices, and processes that a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would employ to significantly minimize or prevent the hazards identified under the hazard analysis conducted under subsection (b) and that are consistent with the current scientific understanding of safe food manufacturing, processing, packing, or holding at the time of the analysis. Those procedures, practices, and processes may include the following:
(A) Sanitation procedures for food contact surfaces and utensils and food-contact surfaces of equipment.
(B) Supervisor, manager, and employee hygiene training.
(C) An environmental monitoring program to verify the effectiveness of pathogen controls in processes where a food is exposed to a potential contaminant in the environment.
(D) A food allergen control program.
(E) A recall plan.
(F) Current Good Manufacturing Practices (cGMPs) under part 110 of title 21, Code of Federal Regulations (or any successor regulations).
(G) Supplier verification activities that relate to the safety of food.
(June 25, 1938, ch. 675, § 418, as added Pub. L. 111–353, title I, § 103(a), Jan. 4, 2011, 124 Stat. 3889.)
§ 350h. Standards for produce safety
(a) Proposed rulemaking
(1) In general
(A) Rulemaking
(B) Determination by Secretary
(2) Public input
(3) ContentThe proposed rulemaking under paragraph (1) shall—
(A) provide sufficient flexibility to be applicable to various types of entities engaged in the production and harvesting of fruits and vegetables that are raw agricultural commodities, including small businesses and entities that sell directly to consumers, and be appropriate to the scale and diversity of the production and harvesting of such commodities;
(B) include, with respect to growing, harvesting, sorting, packing, and storage operations, science-based minimum standards related to soil amendments, hygiene, packaging, temperature controls, animals in the growing area, and water;
(C) consider hazards that occur naturally, may be unintentionally introduced, or may be intentionally introduced, including by acts of terrorism;
(D) take into consideration, consistent with ensuring enforceable public health protection, conservation and environmental practice standards and policies established by Federal natural resource conservation, wildlife conservation, and environmental agencies;
(E) in the case of production that is certified organic, not include any requirements that conflict with or duplicate the requirements of the national organic program established under the Organic Foods Production Act of 1990, while providing the same level of public health protection as the requirements under guidance documents, including guidance documents regarding action levels, and regulations under the FDA Food Safety Modernization Act; and
(F) define, for purposes of this section, the terms “small business” and “very small business”.
(4) Prioritization
(b) Final regulation
(1) In general
(2) Final regulationThe final regulation shall—
(A) provide for coordination of education and enforcement activities by State and local officials, as designated by the Governors of the respective States or the appropriate elected State official as recognized by State statute; and
(B) include a description of the variance process under subsection (c) and the types of permissible variances the Secretary may grant.
(3) Flexibility for small businessesNotwithstanding paragraph (1)—
(A) the regulations promulgated under this section shall apply to a small business (as defined in the regulation promulgated under subsection (a)(1)) after the date that is 1 year after the effective date of the final regulation under paragraph (1); and
(B) the regulations promulgated under this section shall apply to a very small business (as defined in the regulation promulgated under subsection (a)(1)) after the date that is 2 years after the effective date of the final regulation under paragraph (1).
(c) Criteria
(1) In generalThe regulations adopted under subsection (b) shall—
(A) set forth those procedures, processes, and practices that the Secretary determines to minimize the risk of serious adverse health consequences or death, including procedures, processes, and practices that the Secretary determines to be reasonably necessary to prevent the introduction of known or reasonably foreseeable biological, chemical, and physical hazards, including hazards that occur naturally, may be unintentionally introduced, or may be intentionally introduced, including by acts of terrorism, into fruits and vegetables, including specific mixes or categories of fruits and vegetables, that are raw agricultural commodities and to provide reasonable assurances that the produce is not adulterated under section 342 of this title;
(B) provide sufficient flexibility to be practicable for all sizes and types of businesses, including small businesses such as a small food processing facility co-located on a farm;
(C) comply with chapter 35 of title 44 (commonly known as the “Paperwork Reduction Act”), with special attention to minimizing the burden (as defined in section 3502(2) of such title) on the business, and collection of information (as defined in section 3502(3) of such title), associated with such regulations;
(D) acknowledge differences in risk and minimize, as appropriate, the number of separate standards that apply to separate foods; and
(E) not require a business to hire a consultant or other third party to identify, implement, certify, compliance 1
1 So in original. Probably should be “or certify compliance”.
with these procedures, processes, and practices, except in the case of negotiated enforcement resolutions that may require such a consultant or third party; and(F) permit States and foreign countries from which food is imported into the United States to request from the Secretary variances from the requirements of the regulations, subject to paragraph (2), where the State or foreign country determines that the variance is necessary in light of local growing conditions and that the procedures, processes, and practices to be followed under the variance are reasonably likely to ensure that the produce is not adulterated under section 342 of this title and to provide the same level of public health protection as the requirements of the regulations adopted under subsection (b).
(2) Variances
(A) Requests for variances
(B) Approval of variances
(C) Denial of variances
(D) Modification or revocation of a variance
(d) Enforcement
(e) Guidance
(1) In general
(2) Public meetings
(3) Paperwork reduction
(A) provide sufficient flexibility to be practicable for all sizes and types of facilities, including small businesses such as a small food processing facility co-located on a farm; and
(B) acknowledge differences in risk and minimize, as appropriate, the number of separate standards that apply to separate foods.
(f) Exemption for direct farm marketing
(1) In generalA farm shall be exempt from the requirements under this section in a calendar year if—
(A) during the previous 3-year period, the average annual monetary value of the food sold by such farm directly to qualified end-users during such period exceeded the average annual monetary value of the food sold by such farm to all other buyers during such period; and
(B) the average annual monetary value of all food sold during such period was less than $500,000, adjusted for inflation.
(2) Notification to consumers
(A) In generalA farm that is exempt from the requirements under this section shall—
(i) with respect to a food for which a food packaging label is required by the Secretary under any other provision of this chapter, include prominently and conspicuously on such label the name and business address of the farm where the produce was grown; or
(ii) with respect to a food for which a food packaging label is not required by the Secretary under any other provision of this chapter, prominently and conspicuously display, at the point of purchase, the name and business address of the farm where the produce was grown, on a label, poster, sign, placard, or documents delivered contemporaneously with the food in the normal course of business, or, in the case of Internet sales, in an electronic notice.
(B) No additional label
(3) Withdrawal; rule of construction
(A) In general
(B) Rule of construction
(4) Definitions
(A) Qualified end-userIn this subsection, the term “qualified end-user”, with respect to a food means—
(i) the consumer of the food; or
(ii) a restaurant or retail food establishment (as those terms are defined by the Secretary for purposes of section 350d of this title) that is located—(I) in the same State as the farm that produced the food; or(II) not more than 275 miles from such farm.
(B) Consumer
(5) No preemption
(6) Limitation of effect
(g) Clarification
(h) Exception for activities of facilities subject to section 350g of this title
(June 25, 1938, ch. 675, § 419, as added Pub. L. 111–353, title I, § 105(a), Jan. 4, 2011, 124 Stat. 3899.)
§ 350i. Protection against intentional adulteration
(a) Determinations
(1) In general
The Secretary shall—
(A) conduct a vulnerability assessment of the food system, including by consideration of the Department of Homeland Security biological, chemical, radiological, or other terrorism risk assessments;
(B) consider the best available understanding of uncertainties, risks, costs, and benefits associated with guarding against intentional adulteration of food at vulnerable points; and
(C) determine the types of science-based mitigation strategies or measures that are necessary to protect against the intentional adulteration of food.
(2) Limited distribution
(b) Regulations
Not later than 18 months after January 4, 2011, the Secretary, in coordination with the Secretary of Homeland Security and in consultation with the Secretary of Agriculture, shall promulgate regulations to protect against the intentional adulteration of food subject to this chapter. Such regulations shall—
(1) specify how a person shall assess whether the person is required to implement mitigation strategies or measures intended to protect against the intentional adulteration of food; and
(2) specify appropriate science-based mitigation strategies or measures to prepare and protect the food supply chain at specific vulnerable points, as appropriate.
(c) Applicability
Regulations promulgated under subsection (b) shall apply only to food for which there is a high risk of intentional contamination, as determined by the Secretary, in consultation with the Secretary of Homeland Security, under subsection (a), that could cause serious adverse health consequences or death to humans or animals and shall include those foods—
(1) for which the Secretary has identified clear vulnerabilities (including short shelf-life or susceptibility to intentional contamination at critical control points); and
(2) in bulk or batch form, prior to being packaged for the final consumer.
(d) Exception
(e) Definition
(June 25, 1938, ch. 675, § 420, as added Pub. L. 111–353, title I, § 106(a), Jan. 4, 2011, 124 Stat. 3905.)
§ 350j. Targeting of inspection resources for domestic facilities, foreign facilities, and ports of entry; annual report
(a) Identification and inspection of facilities
(1) Identification
The Secretary shall identify high-risk facilities and shall allocate resources to inspect facilities according to the known safety risks of the facilities, which shall be based on the following factors:
(A) The known safety risks of the food manufactured, processed, packed, or held at the facility.
(B) The compliance history of a facility, including with regard to food recalls, outbreaks of foodborne illness, and violations of food safety standards.
(C) The rigor and effectiveness of the facility’s hazard analysis and risk-based preventive controls.
(D) Whether the food manufactured, processed, packed, or held at the facility meets the criteria for priority under section 381(h)(1) of this title.
(E) Whether the food or the facility that manufactured, processed, packed, or held such food has received a certification as described in section 381(q) or 384b of this title, as appropriate.
(F) Any other criteria deemed necessary and appropriate by the Secretary for purposes of allocating inspection resources.
(2) Inspections
(A) In general
(B) Domestic high-risk facilities
The Secretary shall increase the frequency of inspection of domestic facilities identified under paragraph (1) as high-risk facilities such that each such facility is inspected—
(i) not less often than once in the 5-year period following January 4, 2011; and
(ii) not less often than once every 3 years thereafter.
(C) Domestic non-high-risk facilities
(i) not less often than once in the 7-year period following January 4, 2011; and
(ii) not less often than once every 5 years thereafter.
(D) Foreign facilities
(i) Year 1
(ii) Subsequent years
(E) Reliance on Federal, State, or local inspections
(b) Identification and inspection at ports of entry
The Secretary, in consultation with the Secretary of Homeland Security, shall allocate resources to inspect any article of food imported into the United States according to the known safety risks of the article of food, which shall be based on the following factors:
(1) The known safety risks of the food imported.
(2) The known safety risks of the countries or regions of origin and countries through which such article of food is transported.
(3) The compliance history of the importer, including with regard to food recalls, outbreaks of foodborne illness, and violations of food safety standards.
(4) The rigor and effectiveness of the activities conducted by the importer of such article of food to satisfy the requirements of the foreign supplier verification program under section 384a of this title.
(5) Whether the food importer participates in the voluntary qualified importer program under section 384b of this title.
(6) Whether the food meets the criteria for priority under section 381(h)(1) of this title.
(7) Whether the food or the facility that manufactured, processed, packed, or held such food received a certification as described in section 381(q) or 384b of this title.
(8) Any other criteria deemed necessary and appropriate by the Secretary for purposes of allocating inspection resources.
(c) Interagency agreements with respect to seafood
(1) In general
(2) Scope of agreements
The agreements under paragraph (1) may include—
(A) cooperative arrangements for examining and testing seafood imports that leverage the resources, capabilities, and authorities of each party to the agreement;
(B) coordination of inspections of foreign facilities to increase the percentage of imported seafood and seafood facilities inspected;
(C) standardization of data on seafood names, inspection records, and laboratory testing to improve interagency coordination;
(D) coordination to detect and investigate violations under applicable Federal law;
(E) a process, including the use or modification of existing processes, by which officers and employees of the National Oceanic and Atmospheric Administration may be duly designated by the Secretary to carry out seafood examinations and investigations under section 381 of this title or section 203 of the Food Allergen Labeling and Consumer Protection Act of 2004;
(F) the sharing of information concerning observed non-compliance with United States food requirements domestically and in foreign nations and new regulatory decisions and policies that may affect the safety of food imported into the United States;
(G) conducting joint training on subjects that affect and strengthen seafood inspection effectiveness by Federal authorities; and
(H) outreach on Federal efforts to enhance seafood safety and compliance with Federal food safety requirements.
(d) Coordination
(e) Facility
(June 25, 1938, ch. 675, § 421, as added Pub. L. 111–353, title II, § 201(a), Jan. 4, 2011, 124 Stat. 3923.)
§ 350k. Laboratory accreditation for analyses of foods
(a) Recognition of laboratory accreditation
(1) In generalNot later than 2 years after January 4, 2011, the Secretary shall—
(A) establish a program for the testing of food by accredited laboratories;
(B) establish a publicly available registry of accreditation bodies recognized by the Secretary and laboratories accredited by a recognized accreditation body, including the name of, contact information for, and other information deemed appropriate by the Secretary about such bodies and laboratories; and
(C) require, as a condition of recognition or accreditation, as appropriate, that recognized accreditation bodies and accredited laboratories report to the Secretary any changes that would affect the recognition of such accreditation body or the accreditation of such laboratory.
(2) Program requirements
(3) Increasing the number of qualified laboratories
(4) Limited distribution
(5) Foreign laboratories
(6) Model laboratory standardsThe Secretary shall develop model standards that a laboratory shall meet to be accredited by a recognized accreditation body for a specified sampling or analytical testing methodology and included in the registry provided for under paragraph (1). In developing the model standards, the Secretary shall consult existing standards for guidance. The model standards shall include—
(A) methods to ensure that—
(i) appropriate sampling, analytical procedures (including rapid analytical procedures), and commercially available techniques are followed and reports of analyses are certified as true and accurate;
(ii) internal quality systems are established and maintained;
(iii) procedures exist to evaluate and respond promptly to complaints regarding analyses and other activities for which the laboratory is accredited; and
(iv) individuals who conduct the sampling and analyses are qualified by training and experience to do so; and
(B) any other criteria determined appropriate by the Secretary.
(7) Review of recognitionTo ensure compliance with the requirements of this section, the Secretary—
(A) shall periodically, and in no case less than once every 5 years, reevaluate accreditation bodies recognized under paragraph (1) and may accompany auditors from an accreditation body to assess whether the accreditation body meets the criteria for recognition; and
(B) shall promptly revoke the recognition of any accreditation body found not to be in compliance with the requirements of this section, specifying, as appropriate, any terms and conditions necessary for laboratories accredited by such body to continue to perform testing as described in this section.
(b) Testing procedures
(1) In generalNot later than 30 months after January 4, 2011, food testing shall be conducted by Federal laboratories or non-Federal laboratories that have been accredited for the appropriate sampling or analytical testing methodology or methodologies by a recognized accreditation body on the registry established by the Secretary under subsection (a)(1)(B) whenever such testing is conducted—
(A) by or on behalf of an owner or consignee—
(i) in response to a specific testing requirement under this chapter or implementing regulations, when applied to address an identified or suspected food safety problem; and
(ii) as required by the Secretary, as the Secretary deems appropriate, to address an identified or suspected food safety problem; or
(B) on behalf of an owner or consignee—
(i) in support of admission of an article of food under section 381(a) of this title; and
(ii) under an Import Alert that requires successful consecutive tests.
(2) Results of testing
(3) ExceptionThe Secretary may waive requirements under this subsection if—
(A) a new methodology or methodologies have been developed and validated but a laboratory has not yet been accredited to perform such methodology or methodologies; and
(B) the use of such methodology or methodologies are necessary to prevent, control, or mitigate a food emergency or foodborne illness outbreak.
(c) Review by Secretary
(d) No limit on Secretarial authority
(June 25, 1938, ch. 675, § 422, as added Pub. L. 111–353, title II, § 202(a), Jan. 4, 2011, 124 Stat. 3926.)
§ 350l. Mandatory recall authority
(a) Voluntary procedures
(b) Prehearing order to cease distribution and give notice
(1) In generalIf the responsible party refuses to or does not voluntarily cease distribution or recall such article within the time and in the manner prescribed by the Secretary (if so prescribed), the Secretary may, by order require, as the Secretary deems necessary, such person to—
(A) immediately cease distribution of such article; and
(B) as applicable, immediately notify all persons—
(i) manufacturing, processing, packing, transporting, distributing, receiving, holding, or importing and selling such article; and
(ii) to which such article has been distributed, transported, or sold, to immediately cease distribution of such article.1
1 So in original. The words “to immediately cease distribution of such article.” probably should follow cl. (ii).
(2) Required additional information
(A) In general
(B) Rules of constructionNothing in this paragraph shall be construed—
(i) to exempt a warehouse-based third party logistics provider from the requirements of this chapter, including the requirements in this section and section 350c of this title; or
(ii) to exempt a warehouse-based third party logistics provider from being the subject of a mandatory recall order.
(3) Determination to limit areas affected
(c) Hearing on order
(d) Post-hearing recall order and modification of order
(1) Amendment of orderIf, after providing opportunity for an informal hearing under subsection (c), the Secretary determines that removal of the article from commerce is necessary, the Secretary shall, as appropriate—
(A) amend the order to require recall of such article or other appropriate action;
(B) specify a timetable in which the recall shall occur;
(C) require periodic reports to the Secretary describing the progress of the recall; and
(D) provide notice to consumers to whom such article was, or may have been, distributed.
(2) Vacating of order
(e) Rule regarding alcoholic beverages
(f) Cooperation and consultation
(g) Public notificationIn conducting a recall under this section, the Secretary shall—
(1) ensure that a press release is published regarding the recall, as well as alerts and public notices, as appropriate, in order to provide notification—
(A) of the recall to consumers and retailers to whom such article was, or may have been, distributed; and
(B) that includes, at a minimum—
(i) the name of the article of food subject to the recall;
(ii) a description of the risk associated with such article; and
(iii) to the extent practicable, information for consumers about similar articles of food that are not affected by the recall;
(2) consult the policies of the Department of Agriculture regarding providing to the public a list of retail consignees receiving products involved in a Class I recall and shall consider providing such a list to the public, as determined appropriate by the Secretary; and
(3) if available, publish on the Internet Web site of the Food and Drug Administration an image of the article that is the subject of the press release described in (1).2
2 So in original. Probably should be “paragraph (1).”
(h) No delegation
(i) Effect
(j) Coordinated communication
(1) In general
(2) RequirementsTo reduce the potential for miscommunication during recalls or regarding investigations of a food borne illness outbreak associated with a food that is subject to a recall, each incident command operation or similar operation under paragraph (1) shall use regular staff and resources of the Department of Health and Human Services to—
(A) ensure timely and coordinated communication within the Department, including enhanced communication and coordination between different agencies and organizations within the Department;
(B) ensure timely and coordinated communication from the Department, including public statements, throughout the duration of the investigation and related foodborne illness outbreak;
(C) identify a single point of contact within the Department for public inquiries regarding any actions by the Secretary related to a recall;
(D) coordinate with Federal, State, local, and tribal authorities, as appropriate, that have responsibilities related to the recall of a food or a foodborne illness outbreak associated with a food that is subject to the recall, including notification of the Secretary of Agriculture and the Secretary of Education in the event such recalled food is a commodity intended for use in a child nutrition program (as identified in section 1769f(b) of title 42); and
(E) conclude operations at such time as the Secretary determines appropriate.
(3) Multiple recalls
(June 25, 1938, ch. 675, § 423, as added Pub. L. 111–353, title II, § 206(a), Jan. 4, 2011, 124 Stat. 3939.)
§ 350l–1. Annual report to Congress
(1) In general
(2) Content
The report under paragraph (1) shall include, with respect to the report year—
(A) the identity of each article of food that was the subject of a public health advisory described in paragraph (1), an opportunity to cease distribution and recall under subsection (a) of section 350l of this title, or a mandatory recall order under subsection (b) of such section;
(B) the number of responsible parties, as defined in section 350f of this title, formally given the opportunity to cease distribution of an article of food and recall such article, as described in section 350l(a) of such title;
(C) the number of responsible parties described in subparagraph (B) who did not cease distribution of or recall an article of food after given the opportunity to cease distribution or recall under section 350l(a) of this title;
(D) the number of recall orders issued under section 350l(b) of this title; and
(E) a description of any instances in which there was no testing that confirmed adulteration of an article of food that was the subject of a recall under section 350l(b) of this title or a public health advisory described in paragraph (1).
(Pub. L. 111–353, title II, § 206(f), Jan. 4, 2011, 124 Stat. 3943.)
§ 350m. Requirements for critical food
(a) Notification of meaningful disruption for critical food
(1) In general
(2) Distribution of information
(3) Confidentiality
(4) Meaningful disruptionIn this subsection, the term “meaningful disruption”—
(A) means a change in production that is reasonably likely to lead to a significant reduction in the supply of a critical food by a manufacturer that affects the ability of the manufacturer to meet expected demand for its product; and
(B) does not include interruptions in manufacturing due to matters such as routine maintenance, changes or discontinuance of flavors, colors, or other insignificant formulation characteristics, or insignificant changes in manufacturing so long as the manufacturer expects to resume operations in a short period of time.
(b) Risk management plansEach manufacturer of a critical food shall develop, maintain, and implement, as appropriate, a redundancy risk management plan that identifies and evaluates risks to the supply of the food, as applicable, for each establishment in which such food is manufactured. A risk management plan under this subsection—
(1) may identify and evaluate risks to the supply of more than one critical food, or critical food category, manufactured at the same establishment;
(2) may identify mechanisms by which the manufacturer would mitigate the impacts of a supply disruption through alternative production sites, alternative suppliers, stockpiling of inventory, or other means; and
(3) shall be subject to inspection and copying by the Secretary pursuant to an inspection under section 374 of this title.
(c) Failure to meet requirements
(1) In generalIf a person fails to submit information required under, and in accordance with, subsection (a)—
(A) the Secretary shall issue a letter to such person informing such person of such failure; and
(B) not later than 45 calendar days after the issuance of a letter under subparagraph (A), subject to paragraph (2), the Secretary shall make available to the public on the website of the Food and Drug Administration, with appropriate redactions made to protect the information described in subsection (a)(3)—
(i) the letter issued under subparagraph (A); and
(ii) at the request of such person, any response to such letter such person submitted to the Secretary.
(2) Exception
(June 25, 1938, ch. 675, § 424, as added Pub. L. 117–328, div. FF, title III, § 3401(k), Dec. 29, 2022, 136 Stat. 5844.)