Notes on 21 U.S.C. § 341 : US Code - Notes

Search Notes on 21 U.S.C. § 341 : US Code - Notes

(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 (a) as entire section and repealed subsec.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 notes set out under
section 321 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.