§ 341. — Definitions and standards for food.
[Laws in effect as of January 24, 2002]
[Document not affected by Public Laws enacted between
January 24, 2002 and December 19, 2002]
[CITE: 21USC341]
TITLE 21--FOOD AND DRUGS
CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV--FOOD
Sec. 341. Definitions and standards for food
Whenever in the judgment of the Secretary such action will promote
honesty and fair dealing in the interest of consumers, he shall
promulgate regulations fixing and establishing for any food, under its
common or usual name so far as practicable, a reasonable definition and
standard of identity, a reasonable standard of quality, or reasonable
standards of fill of container. No definition and standard of identity
and no standard of quality shall be established for fresh or dried
fruits, fresh or dried vegetables, or butter, except that definitions
and standards of identity may be established for avocadoes, cantaloupes,
citrus fruits, and melons. In prescribing any standard of fill of
container, the Secretary shall give due consideration to the natural
shrinkage in storage and in transit of fresh natural food and to need
for the necessary packing and protective material. In the prescribing of
any standard of quality for any canned fruit or canned vegetable,
consideration shall be given and due allowance made for the differing
characteristics of the several varieties of such fruit or vegetable. In
prescribing a definition and standard of identity for any food or class
of food in which optional ingredients are permitted, the Secretary
shall, for the purpose of promoting honesty and fair dealing in the
interest of consumers, designate the optional ingredients which shall be
named on the label. Any definition and standard of identity prescribed
by the Secretary for avocadoes, cantaloupes, citrus fruits, or melons
shall relate only to maturity and to the effects of freezing.
(June 25, 1938, ch. 675, Sec. 401, 52 Stat. 1046; Apr. 15, 1954, ch.
143, Sec. 1, 68 Stat. 54; Aug. 1, 1956, ch. 861, Sec. 1, 70 Stat. 919;
Pub. L. 103-80, Sec. 3(h), Aug. 13, 1993, 107 Stat. 776.)
Amendments
1993--Pub. L. 103-80 substituted ``or reasonable standards of fill
of container. No definition'' for ``and/or reasonable standards of fill
of container: Provided, That no definition''.
1956--Act Aug. 1, 1956, designated provisions constituting subsec.
(a) as entire section and repealed subsec. (b) which provided the
procedure for establishment of regulations and is covered by section
371(e) of this title.
1954--Act Apr. 15, 1954, designated existing provisions as subsec.
(a) and added subsec. (b).
Savings Provision
Section 3 of act Aug. 1, 1956, provided that: ``In any case in
which, prior to the enactment of this Act [Aug. 1, 1956], a public
hearing has been begun in accordance with section 401 of the Federal
Food, Drug, and Cosmetic Act [341 of this title] upon a proposal to
issue, amend, or repeal any regulation contemplated by such section, or
has been begun in accordance with section 701(e) of such Act [section
371(e) of this title] upon a proposal to issue, amend, or repeal any
regulation contemplated by section 403(j), 404(a), 406(a) or (b),
501(b), 502(d), 502(h), 504 or 604 of such Act [section 343(j), 344(a),
346(a) or (b), 351(b), 352(d), 352(h), 354, or 364 of this title], the
provisions of such section 401 or 701(e), as the case may be, as in
force immediately prior to the date of the enactment of this Act [Aug.
1, 1956], shall be applicable as though this Act [amending this section
and section 371(e) of this title] had not been enacted.''
Transfer of Functions
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare [now Health and Human
Services], and of Food and Drug Administration in the Department of
Agriculture to Federal Security Agency, see note set out under section
41 of this title.
Food Safety and Security Strategy
Pub. L. 107-188, title III, Sec. 301, June 12, 2002, 116 Stat. 662,
provided that:
``(a) In General.--The President's Council on Food Safety (as
established by Executive Order No. 13100 [set out below]) shall, in
consultation with the Secretary of Transportation, the Secretary of the
Treasury, other relevant Federal agencies, the food industry, consumer
and producer groups, scientific organizations, and the States, develop a
crisis communications and education strategy with respect to
bioterrorist threats to the food supply. Such strategy shall address
threat assessments; technologies and procedures for securing food
processing and manufacturing facilities and modes of transportation;
response and notification procedures; and risk communications to the
public.
``(b) Authorization of Appropriations.--For the purpose of
implementing the strategy developed under subsection (a), there are
authorized to be appropriated $750,000 for fiscal year 2002, and such
sums as may be necessary for each subsequent fiscal year.''
Food Safety Commission
Pub. L. 107-171, title X, Sec. 10807, May 13, 2002, 116 Stat. 527,
provided that:
``(a) Establishment.--
``(1) In general.--There is established a commission to be known
as the `Food Safety Commission' (referred to in this section as the
`Commission').
``(2) Membership.--
``(A) Composition.--The Commission shall be composed of 15
members (including a Chairperson, appointed by the President[)].
``(B) Eligibility.--
``(i) In general.--Members of the Commission--
``(I) shall have specialized training or significant
experience in matters under the jurisdiction of the
Commission; and
``(II) shall represent, at a minimum--
``(aa) consumers;
``(bb) food scientists;
``(cc) the food industry; and
``(dd) health professionals.
``(ii) Federal employees.--Not more than 3 members of
the Commission may be Federal employees.
``(C) Date of appointments.--The appointment of the members
of the Commission shall be made as soon as practicable after the
date on which funds authorized to be appropriated under
subsection (e)(1) are made available.
``(D) Vacancies.--A vacancy on the Commission--
``(i) shall not affect the powers of the Commission; and
``(ii) shall be filled--
``(I) not later than 60 days after the date on which the
vacancy occurs; and
``(II) in the same manner as the original appointment was
made.
``(3) Meetings.--
``(A) Initial meeting.--The initial meeting of the
Commission shall be conducted not later than 30 days after the
date of appointment of the final member of the Commission.
``(B) Other meetings.--The Commission shall meet at the call
of the Chairperson.
``(4) Quorum; standing rules.--
``(A) Quorum.--A majority of the members of the Commission
shall constitute a quorum to conduct business.
``(B) Standing rules.--At the first meeting of the
Commission, the Commission shall adopt standing rules of the
Commission to guide the conduct of business and decisionmaking
of the Commission.
``(b) Duties.--
``(1) Recommendations.--The Commission shall make specific
recommendations to enhance the food safety system of the United
States, including a description of how each recommendation would
improve food safety.
``(2) Components.--Recommendations made by the Commission under
paragraph (1) shall address all food available commercially in the
United States.
``(3) Report.--Not later than 1 year after the date on which the
Commission first meets, the Commission shall submit to the President
and Congress--
``(A) the findings, conclusions, and recommendations of the
Commission, including a description of how each recommendation
would improve food safety;
``(B) a summary of any other material used by the Commission
in the preparation of the report under this paragraph; and
``(C) if requested by 1 or more members of the Commission, a
statement of the minority views of the Commission.
``(c) Powers of the Commission.--
``(1) Hearings.--The Commission may, for the purpose of carrying
out this section, hold such hearings, meet and act at such times and
places, take such testimony, and receive such evidence as the
Commission considers advisable.
``(2) Information from federal agencies.--
``(A) In general.--The Commission may secure directly, from
any Federal agency, such information as the Commission considers
necessary to carry out this section.
``(B) Provision of information.--
``(i) In general.--Subject to subparagraph (C), on the
request of the Commission, the head of a Federal agency
described in subparagraph (A) may furnish information
requested by the Commission to the Commission.
``(ii) Administration.--The furnishing of information by
a Federal agency to the Commission shall not be considered a
waiver of any exemption available to the agency under
section 552 of title 5, United States Code.
``(C) Information to be kept confidential.--
``(i) In general.--For purposes of section 1905 of title
18, United States Code--
``(I) the Commission shall be considered an agency of the
Federal Government; and
``(II) any individual employed by an individual, entity, or
organization that is a party to a contract with the
Commission under this section shall be considered an
employee of the Commission.
``(ii) Prohibition on disclosure.--Information obtained
by the Commission, other than information that is available
to the public, shall not be disclosed to any person in any
manner except to an employee of the Commission as described
in clause (i), for the purpose of receiving, reviewing, or
processing the information.
``(d) Commission Personnel Matters.--
``(1) Members.--
``(A) Compensation.--A member of the Commission shall serve
without compensation for the services of the member on the
Commission.
``(B) Travel expenses.--A member of the Commission shall be
allowed travel expenses, including per diem in lieu of
subsistence, at rates authorized for an employee of an agency
under subchapter I of chapter 57 of title 5, United States Code,
while away from the home or regular place of business of the
member in the performance of the duties of the Commission.
``(2) Staff.--
``(A) In general.--The Chairperson of the Commission may,
without regard to the civil service laws (including
regulations), appoint and terminate the appointment of an
executive director and such other additional personnel as are
necessary to enable the Commission to perform the duties of the
Commission.
``(B) Confirmation of executive director.--The employment of
an executive director shall be subject to confirmation by the
Commission.
``(C) Compensation.--
``(i) In general.--Except as provided in clause (ii),
the Chairperson of the Commission may fix the compensation
of the executive director and other personnel without regard
to the provisions of chapter 51 and subchapter III of
chapter 53 of title 5, United States Code, relating to
classification of positions and General Schedule pay rates.
``(ii) Maximum rate of pay.--The rate of pay for the
executive director and other personnel shall not exceed the
rate payable for level II of the Executive Schedule under
section 5316 of title 5, United States Code.
``(3) Detail of federal government employees.--
``(A) In general.--An employee of the Federal Government may
be detailed to the Commission, without reimbursement, for such
period of time as is permitted by law.
``(B) Civil service status.--The detail of the employee
shall be without interruption or loss of civil service status or
privilege.
``(4) Procurement of temporary and intermittent services.--The
Chairperson of the Commission may procure temporary and intermittent
services in accordance with section 3109(b) of title 5, United
States Code, at rates for individuals that do not exceed the daily
equivalent of the annual rate of basic pay prescribed for level II
of the Executive Schedule under section 5316 of that title.
``(e) Authorization of Appropriations.--
``(1) In general.--There is authorized to be appropriated such
sums as are necessary to carry out this section.
``(2) Limitation.--No payment may be made under subsection (d)
except to the extent provided for in advance in an appropriations
Act.
``(f) Termination.--The Commission shall terminate on the date that
is 60 days after the date on which the Commission submits the
recommendations and report under subsection (b)(3).''
Ex. Ord. No. 13100. President's Council on Food Safety
Ex. Ord. No. 13100, Aug. 25, 1998, 63 F.R. 45661, as amended by Ex.
Ord. No. 13286, Sec. 16, Feb. 28, 2003, 68 F.R. 10623, provided:
By the authority vested in me as President by the Constitution and
the laws of the United States of America, and in order to improve the
safety of the food supply through science-based regulation and well-
coordinated inspection, enforcement, research, and education programs,
it is hereby ordered as follows:
Section 1. Establishment of President's Council on Food Safety. (a)
There is established the President's Council on Food Safety
(``Council''). The Council shall comprise the Secretaries of
Agriculture, Commerce, Health and Human Services, and Homeland Security,
the Director of the Office of Management and Budget (OMB), the
Administrator of the Environmental Protection Agency, the Assistant to
the President for Science and Technology/Director of the Office of
Science and Technology Policy, the Assistant to the President for
Domestic Policy, and the Director of the National Partnership for
Reinventing Government. The Council shall consult with other Federal
agencies and State, local, and tribal government agencies, and consumer,
producer, scientific, and industry groups, as appropriate.
(b) The Secretaries of Agriculture and of Health and Human Services
and the Assistant to the President for Science and Technology/Director
of the Office of Science and Technology Policy shall serve as Joint
Chairs of the Council.
Sec. 2. Purpose. The purpose of the Council shall be to develop a
comprehensive strategic plan for Federal food safety activities, taking
into consideration the findings and recommendations of the National
Academy of Sciences report ``Ensuring Safe Food from Production to
Consumption'' and other input from the public on how to improve the
effectiveness of the current food safety system. The Council shall make
recommendations to the President on how to advance Federal efforts to
implement a comprehensive science-based strategy to improve the safety
of the food supply and to enhance coordination among Federal agencies,
State, local, and tribal governments, and the private sector. The
Council shall advise Federal agencies in setting priority areas for
investment in food safety.
Sec. 3. Specific Activities and Functions. (a) The Council shall
develop a comprehensive strategic Federal food safety plan that contains
specific recommendations on needed changes, including measurable outcome
goals. The principal goal of the plan should be the establishment of a
seamless, science-based food safety system. The plan should address the
steps necessary to achieve this goal, including the key public health,
resource, and management issues regarding food safety. The planning
process should consider both short-term and long-term issues including
new and emerging threats and the special needs of vulnerable populations
such as children and the elderly. In developing this plan, the Council
shall consult with all interested parties, including State and local
agencies, tribes, consumers, producers, industry, and academia.
(b) Consistent with the comprehensive strategic Federal food safety
plan described in section 3(a) of this order, the Council shall advise
agencies of priority areas for investment in food safety and ensure that
Federal agencies annually develop coordinated food safety budgets for
submission to the OMB that sustain and strengthen existing capacities,
eliminate duplication, and ensure the most effective use of resources
for improving food safety. The Council shall also ensure that Federal
agencies annually develop a unified budget for submission to the OMB for
the President's Food Safety Initiative and such other food safety issues
as the Council determines appropriate.
(c) The Council shall ensure that the Joint Institute for Food
Safety Research (JIFSR), in consultation with the National Science and
Technology Council, establishes mechanisms to guide Federal research
efforts toward the highest priority food safety needs. The JIFSR shall
report to the Council on a regular basis on its efforts: (i) to develop
a strategic plan for conducting food safety research activities
consistent with the President's Food Safety Initiative and such other
food safety activities as the JIFSR determines appropriate; and (ii) to
coordinate efficiently, within the executive branch and with the private
sector and academia, all Federal food safety research.
Sec. 4. Cooperation. All actions taken by the Council shall, as
appropriate, promote partnerships and cooperation with States, tribes,
and other public and private sector efforts wherever possible to improve
the safety of the food supply.
Sec. 5. General Provisions. This order is intended only to improve
the internal management of the executive branch and is not intended to,
nor does it, create any right or benefit, substantive or procedural,
enforceable at law by a party against the United States, its agencies,
its officers or any person. Nothing in this order shall affect or alter
the statutory responsibilities of any Federal agency charged with food
safety responsibilities.
Section Referred to in Other Sections
This section is referred to in sections 337, 343, 343-1, 350, 371 of
this title.
