Authorizing Legislation 2

Page 871
CONSTRUCTION

Pub. L. 110–85, title X, § 1005(g), Sept. 27, 2007, 121
Stat. 969, provided that: ‘‘Nothing in this title [enacting this chapter and section 350f of this title, amending
sections 321 and 331 of this title, and enacting provisions set out as notes under section 350f of this title],
or an amendment made by this title, shall be construed
to alter the jurisdiction between the Secretaries of Agriculture and of Health and Human Services, under applicable statutes and regulations.’’

CHAPTER 27—FOOD SAFETY
MODERNIZATION
SUBCHAPTER I—IMPROVING CAPACITY TO
PREVENT FOOD SAFETY PROBLEMS
Sec.

2201.
2202.
2203.
2204.
2205.
2206.

Performance standards.
National Agriculture and Food Defense strategy.
Food and Agriculture Coordinating Councils.
Building domestic capacity.
Food allergy and anaphylaxis management.
Alcohol-related facilities.

SUBCHAPTER II—IMPROVING CAPACITY TO DETECT AND RESPOND TO FOOD SAFETY PROBLEMS
2221.
2222.
2223.
2224.
2225.

Food emergency response network.
Integrated consortium of laboratory networks.
Enhancing tracking and tracing of food and
recordkeeping.
Surveillance.
Decontamination and disposal standards and
plans.

SUBCHAPTER III—IMPROVING THE SAFETY OF
IMPORTED FOOD
2241.
2242.
2243.

Inspection by the Secretary of Commerce.
Foreign offices of the Food and Drug Administration.
Smuggled food.

SUBCHAPTER IV—MISCELLANEOUS PROVISIONS
2251.
2252.

§ 2202

TITLE 21—FOOD AND DRUGS

Jurisdiction; authorities.
Compliance with international agreements.

SUBCHAPTER I—IMPROVING CAPACITY TO
PREVENT FOOD SAFETY PROBLEMS
§ 2201. Performance standards
(a) In general
The Secretary shall, in coordination with the
Secretary of Agriculture, not less frequently
than every 2 years, review and evaluate relevant
health data and other relevant information, including from toxicological and epidemiological
studies and analyses, current Good Manufacturing Practices issued by the Secretary relating to
food, and relevant recommendations of relevant
advisory committees, including the Food Advisory Committee, to determine the most significant foodborne contaminants.
(b) Guidance documents and regulations
Based on the review and evaluation conducted
under subsection (a), and when appropriate to
reduce the risk of serious illness or death to humans or animals or to prevent adulteration of
the food under section 342 of this title or to prevent the spread by food of communicable disease
under section 264 of title 42, the Secretary shall
issue contaminant-specific and science-based
guidance documents, including guidance docu-

ments regarding action levels, or regulations.
Such guidance, including guidance regarding action levels, or regulations—
(1) shall apply to products or product classes;
(2) shall, where appropriate, differentiate between food for human consumption and food
intended for consumption by animals other
than humans; and
(3) shall not be written to be facility-specific.
(c) No duplication of efforts
The Secretary shall coordinate with the Secretary of Agriculture to avoid issuing duplicative guidance on the same contaminants.
(d) Review
The Secretary shall periodically review and
revise, as appropriate, the guidance documents,
including guidance documents regarding action
levels, or regulations promulgated under this
section.
(Pub. L. 111–353, title I, § 104, Jan. 4, 2011, 124
Stat. 3899.)
REFERENCES IN TEXT
The Secretary, referred to in text, probably means
the Secretary of Health and Human Services.
SHORT TITLE
Pub. L. 111–353, § 1(a), Jan. 4, 2011, 124 Stat. 3885, provided that: ‘‘This Act [enacting this chapter 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, amending sections 331, 333, 334, 350b to 350d, 350f,
374, 381, 393, and 399 of this title and section 247b–20 of
Title 42, and enacting provisions set out as notes under
sections 331, 334, 342, 350b, 350d, 350e, 350g to 350j, 350l,
and 381 of this title] may be cited as the ‘FDA Food
Safety Modernization Act’.’’

§ 2202. National Agriculture and Food Defense
strategy
(a) Development and submission of strategy
(1) In general
Not later than 1 year after January 4, 2011,
the Secretary of Health and Human Services
and the Secretary of Agriculture, in coordination with the Secretary of Homeland Security,
shall prepare and transmit to the relevant
committees of Congress, and make publicly
available on the Internet Web sites of the Department of Health and Human Services and
the Department of Agriculture, the National
Agriculture and Food Defense Strategy.
(2) Implementation plan
The strategy shall include an implementation plan for use by the Secretaries described
under paragraph (1) in carrying out the strategy.
(3) Research
The strategy shall include a coordinated research agenda for use by the Secretaries described under paragraph (1) in conducting research to support the goals and activities described in paragraphs (1) and (2) of subsection
(b).
(4) Revisions
Not later than 4 years after the date on
which the strategy is submitted to the rel-