Not later than 1 year after January 4, 2011, the Secretary, in coordination with the Secretary of Agriculture and representatives of State departments of agriculture (including with regard to the national organic program established under the Organic Foods Production Act of 1990 [7 U.S.C. 6501 et seq.]), and in consultation with the Secretary of Homeland Security, shall publish a notice of proposed rulemaking to establish science-based minimum standards for the safe production and harvesting of those types of fruits and vegetables, including specific mixes or categories of fruits and vegetables, that are raw agricultural commodities for which the Secretary has determined that such standards minimize the risk of serious adverse health consequences or death.
With respect to small businesses and very small businesses (as such terms are defined in the regulation promulgated under subparagraph (A)) that produce and harvest those types of fruits and vegetables that are raw agricultural commodities that the Secretary has determined are low risk and do not present a risk of serious adverse health consequences or death, the Secretary may determine not to include production and harvesting of such fruits and vegetables in such rulemaking, or may modify the applicable requirements of regulations promulgated pursuant to this section.
During the comment period on the notice of proposed rulemaking under paragraph (1), the Secretary shall conduct not less than 3 public meetings in diverse geographical areas of the United States to provide persons in different regions an opportunity to comment.
The proposed rulemaking under paragraph (1) shall-
The Secretary shall prioritize the implementation of the regulations under this section for specific fruits and vegetables that are raw agricultural commodities based on known risks which may include a history and severity of foodborne illness outbreaks.
Not later than 1 year after the close of the comment period for the proposed rulemaking under subsection (a), the Secretary shall adopt a final regulation to provide for minimum science-based standards for those types of fruits and vegetables, including specific mixes or categories of fruits or vegetables, that are raw agricultural commodities, based on known safety risks, which may include a history of foodborne illness outbreaks.
The final regulation shall-
Notwithstanding paragraph (1)-
The regulations adopted under subsection (b) shall-
A State or foreign country from which food is imported into the United States may in writing request a variance from the Secretary. Such request shall describe the variance requested and present information demonstrating that the variance does not increase the likelihood that the food for which the variance is requested will be adulterated under section 342 of this title, and that the variance provides the same level of public health protection as the requirements of the regulations adopted under subsection (b). The Secretary shall review such requests in a reasonable timeframe.
The Secretary may approve a variance in whole or in part, as appropriate, and may specify the scope of applicability of a variance to other similarly situated persons.
The Secretary may deny a variance request if the Secretary determines that such variance is not reasonably likely to ensure that the food is not adulterated under section 342 of this title and is not reasonably likely to provide the same level of public health protection as the requirements of the regulation adopted under subsection (b). The Secretary shall notify the person requesting such variance of the reasons for the denial.
The Secretary, after notice and an opportunity for a hearing, may modify or revoke a variance if the Secretary determines that such variance is not reasonably likely to ensure that the food is not adulterated under section 342 of this title and is not reasonably likely to provide the same level of public health protection as the requirements of the regulations adopted under subsection (b).
The Secretary may coordinate with the Secretary of Agriculture and, as appropriate, shall contract and coordinate with the agency or department designated by the Governor of each State to perform activities to ensure compliance with this section.
Not later than 1 year after January 4, 2011, the Secretary shall publish, after consultation with the Secretary of Agriculture, representatives of State departments of agriculture, farmer representatives, and various types of entities engaged in the production and harvesting or importing of fruits and vegetables that are raw agricultural commodities, including small businesses, updated good agricultural practices and guidance for the safe production and harvesting of specific types of fresh produce under this section.
The Secretary shall conduct not fewer than 3 public meetings in diverse geographical areas of the United States as part of an effort to conduct education and outreach regarding the guidance described in paragraph (1) for persons in different regions who are involved in the production and harvesting of fruits and vegetables that are raw agricultural commodities, including persons that sell directly to consumers and farmer representatives, and for importers of fruits and vegetables that are raw agricultural commodities.
The Secretary shall ensure that any updated guidance under this section will-
A farm shall be exempt from the requirements under this section in a calendar year if-
A farm that is exempt from the requirements under this section shall-
Subparagraph (A) does not provide authority to the Secretary to require a label that is in addition to any label required under any other provision of this chapter.
In the event of an active investigation of a foodborne illness outbreak that is directly linked to a farm subject to an exemption under this subsection, or if the Secretary determines that it is necessary to protect the public health and prevent or mitigate a foodborne illness outbreak based on conduct or conditions associated with a farm that are material to the safety of the food produced or harvested at such farm, the Secretary may withdraw the exemption provided to such farm under this subsection.
Nothing in this subsection shall be construed to expand or limit the inspection authority of the Secretary.
In this subsection, the term "qualified end-user", with respect to a food means-
For purposes of subparagraph (A), the term "consumer" does not include a business.
Nothing in this subsection preempts State, local, county, or other non-Federal law regarding the safe production, harvesting, holding, transportation, and sale of fresh fruits and vegetables. Compliance with this subsection shall not relieve any person from liability at common law or under State statutory law.
Nothing in this subsection shall prevent the Secretary from exercising any authority granted in the other sections of this chapter.
This section shall not apply to produce that is produced by an individual for personal consumption.
This section shall not apply to activities of a facility that are subject to section 350g of this title.
1So in original. Probably should be "or certify compliance".
21 U.S.C. § 350h
EDITORIAL NOTES
REFERENCES IN TEXTThe Organic Foods Production Act of 1990, referred to in subsec. (a)(1)(A), (3)(E), is title XXI of Pub. L. 101-624, 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, 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
CONSTRUCTIONNothing 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."