(a) Proposed rulemaking
(1) In general
(A) Rulemaking
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.
(B) Determination by Secretary
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.
(2) Public input
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.
(3) Content
The 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
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.
(b) Final regulation
(1) In general
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.
(2) Final regulation
The 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 businesses
Notwithstanding 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 general
The 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 with these procedures, processes, an
