Collapse to view only § 1639. Definitions

§ 1639. Definitions
In this subchapter:
(1) Bioengineering
The term “bioengineering”, and any similar term, as determined by the Secretary, with respect to a food, refers to a food—
(A) that contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques; and
(B) for which the modification could not otherwise be obtained through conventional breeding or found in nature.
(2) Food
(3) Secretary
(Aug. 14, 1946, ch. 966, title II, § 291, as added Pub. L. 114–216, § 1, July 29, 2016, 130 Stat. 834.)
§ 1639a. Applicability
(a) In general
(b) Application of definition
(c) Application to foodsThis subchapter shall apply only to a food subject to—
(1) the labeling requirements under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.); or
(2) the labeling requirements under 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.) only if—
(A) the most predominant ingredient of the food would independently be subject to the labeling requirements under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.); or
(B)
(i) the most predominant ingredient of the food is broth, stock, water, or a similar solution; and
(ii) the second-most predominant ingredient of the food would independently be subject to the labeling requirements under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
(Aug. 14, 1946, ch. 966, title II, § 292, as added Pub. L. 114–216, § 1, July 29, 2016, 130 Stat. 834.)
§ 1639b. Establishment of national bioengineered food disclosure standard
(a) Establishment of mandatory standardNot later than 2 years after July 29, 2016, the Secretary shall—
(1) establish a national mandatory bioengineered food disclosure standard with respect to any bioengineered food and any food that may be bioengineered; and
(2) establish such requirements and procedures as the Secretary determines necessary to carry out the standard.
(b) Regulations
(1) In general
(2) RequirementsA regulation promulgated by the Secretary in carrying out this subchapter shall—
(A) prohibit a food derived from an animal to be considered a bioengineered food solely because the animal consumed feed produced from, containing, or consisting of a bioengineered substance;
(B) determine the amounts of a bioengineered substance that may be present in food, as appropriate, in order for the food to be a bioengineered food;
(C) establish a process for requesting and granting a determination by the Secretary regarding other factors and conditions under which a food is considered a bioengineered food;
(D) in accordance with subsection (d), require that the form of a food disclosure under this section be a text, symbol, or electronic or digital link, but excluding Internet website Uniform Resource Locators not embedded in the link, with the disclosure option to be selected by the food manufacturer;
(E) provide alternative reasonable disclosure options for food contained in small or very small packages;
(F) in the case of small food manufacturers, provide—
(i) an implementation date that is not earlier than 1 year after the implementation date for regulations promulgated in accordance with this section; and
(ii) on-package disclosure options, in addition to those available under subparagraph (D), to be selected by the small food manufacturer, that consist of—(I) a telephone number accompanied by appropriate language to indicate that the phone number provides access to additional information; and(II) an Internet website maintained by the small food manufacturer in a manner consistent with subsection (d), as appropriate; and
(G) exclude—
(i) food served in a restaurant or similar retail food establishment; and
(ii) very small food manufacturers.
(3) Safety
(c) Study of electronic or digital link disclosure
(1) In general
(2) Public comments
(3) FactorsThe study conducted under paragraph (1) shall consider whether consumer access to the bioengineering disclosure through electronic or digital disclosure methods under this subchapter would be affected by the following factors:
(A) The availability of wireless Internet or cellular networks.
(B) The availability of landline telephones in stores.
(C) Challenges facing small retailers and rural retailers.
(D) The efforts that retailers and other entities have taken to address potential technology and infrastructure challenges.
(E) The costs and benefits of installing in retail stores electronic or digital link scanners or other evolving technology that provide bioengineering disclosure information.
(4) Additional disclosure options
(d) DisclosureIn promulgating regulations under this section, the Secretary shall ensure that—
(1) on-package language accompanies—
(A) the electronic or digital link disclosure, indicating that the electronic or digital link will provide access to an Internet website or other landing page by stating only “Scan here for more food information”, or equivalent language that only reflects technological changes; or
(B) any telephone number disclosure, indicating that the telephone number will provide access to additional information by stating only “Call for more food information.”;
(2) the electronic or digital link will provide access to the bioengineering disclosure located, in a consistent and conspicuous manner, on the first product information page that appears for the product on a mobile device, Internet website, or other landing page, which shall exclude marketing and promotional information;
(3)
(A) the electronic or digital link disclosure may not collect, analyze, or sell any personally identifiable information about consumers or the devices of consumers; but
(B) if information described in subparagraph (A) must be collected to carry out the purposes of this subchapter, that information shall be deleted immediately and not used for any other purpose;
(4) the electronic or digital link disclosure also includes a telephone number that provides access to the bioengineering disclosure; and
(5) the electronic or digital link disclosure is of sufficient size to be easily and effectively scanned or read by a digital device.
(e) State food labeling standards
(f) Consistency with certain lawsThe Secretary shall consider establishing consistency between—
(1) the national bioengineered food disclosure standard established under this section; and
(2) the Organic Foods Production Act of 1990 (7 U.S.C. 6501 et seq.) and any rules or regulations implementing that Act.
(g) Enforcement
(1) Prohibited act
(2) Recordkeeping
(3) Examination and audit
(A) In general
(B) Notice and hearing
(C) Audit results
(4) Recall authority
(Aug. 14, 1946, ch. 966, title II, § 293, as added Pub. L. 114–216, § 1, July 29, 2016, 130 Stat. 835.)
§ 1639c. Savings provisions
(a) Trade
(b) Other authorities
Nothing in this subchapter—
(1) affects the authority of the Secretary of Health and Human Services or creates any rights or obligations for any person under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.); or
(2) affects the authority of the Secretary of the Treasury or creates any rights or obligations for any person under the Federal Alcohol Administration Act (27 U.S.C. 201 et seq.).
(c) Other
(Aug. 14, 1946, ch. 966, title II, § 294, as added Pub. L. 114–216, § 1, July 29, 2016, 130 Stat. 838.)