1
So in original. Probably should be “or certify compliance”.
References in Text
The Organic Foods Production Act of 1990, referred to in subsec. (a)(1)(A), (3)(E), is title XXI of [Pub. L. 101–624], Nov. 28, 1990, [104 Stat. 3935], which is classified generally to chapter 94 (§ 6501 et seq.) of Title 7, Agriculture. For complete classification of this Act to the Code, see Short Title note set out under section 6501 of Title 7 and Tables.
The FDA Food Safety Modernization Act, referred to in subsec. (a)(3)(E), is [Pub. L. 111–353], Jan. 4, 2011, [124 Stat. 3885], which enacted chapter 27 (§ 2201 et seq.) and sections 350g to 350l–1, 379j–31, 384a to 384d, 399c, and 399d of this title, section 7625 of Title 7, Agriculture, and section 280g–16 of Title 42, The Public Health and Welfare, amended sections 331, 333, 334, 350b to 350d, 350f, 374, 381, 393, and 399 of this title and section 247b–20 of Title 42, and enacted provisions set out as notes under sections 331, 334, 342, 350b, 350d, 350e, 350g to 350j, 350l, and 381 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 2201 of this title and Tables.
Statutory Notes and Related Subsidiaries
Construction
Nothing in this section to be construed to apply to certain alcohol-related facilities, to alter jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with international agreements to which the United States is a party, see sections 2206, 2251, and 2252 of this title.
Scientific and Economic Analysis of the FDA Food Safety Modernization Act
[Pub. L. 113–79, title XII, § 12311(a)], Feb. 7, 2014, [128 Stat. 992], provided that: “When publishing a final rule with respect to ‘Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption’ published by the Department of Health and Human Services on January 16, 2013 (78 Fed. Reg. 3504), the Secretary of Health and Human Services (referred to in this section as the ‘Secretary’) shall ensure that the final rule (referred to in this section as the ‘final rule’) includes the following information:“(1)
An analysis of the scientific information used to promulgate the final rule, taking into consideration any information about farming and ranching operations of a variety of sizes, with regional differences, and that have a diversity of production practices and methods.
“(2)
An analysis of the economic impact of the final rule.
“(3)
A plan to systematically—
“(A)
evaluate the impact of the final rule on farming and ranching operations; and
“(B)
develop an ongoing process to evaluate and respond to business concerns.”
Small Entity Compliance Policy Guide
[Pub. L. 111–353, title I, § 105(b)], Jan. 4, 2011, [124 Stat. 3904], provided that: “Not later than 180 days after the issuance of regulations under section 419 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 350h] (as added by subsection (a)), the Secretary of Health and Human Services shall issue a small entity compliance policy guide setting forth in plain language the requirements of such section 419 and to assist small entities in complying with standards for safe production and harvesting and other activities required under such section.”
No Effect on HACCP Authorities
[Pub. L. 111–353, title I, § 105(d)], Jan. 4, 2011, [124 Stat. 3905], provided that: “Nothing in the amendments made by this section [enacting this section and amending section 331 of this title] limits the authority of the Secretary [of Health and Human Services] under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or the Public Health Service Act (42 U.S.C. 201 et seq.) to revise, issue, or enforce product and category-specific regulations, such as the Seafood Hazard Analysis Critical Controls Points Program, the Juice Hazard Analysis Critical Control [Points] Program, and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers standards.”