21 U.S.C. § 341 — Definitions and standards for food

Page 77 TITLE 21—FOOD AND DRUGS § 341 (C) if the Secretary is diligently prosecuting a proceeding in court pertaining to such food, has settled such proceeding, or has settled the informal or formal enforcement action per- taining to such food. In any court proceeding described in subpara- graph (C), a State may intervene as a matter of right. (June 25, 1938, ch. 675, § 310, formerly § 307, 52 Stat. 1046; Sept. 3, 1954, ch. 1263, § 37, 68 Stat. 1239; Pub. L. 101–535, § 4, Nov. 8, 1990, 104 Stat. 2362; renumbered § 310, Pub. L. 102–282, § 2, May 13, 1992, 106 Stat. 150.) Editorial Notes AMENDMENTS 1990—Pub. L. 101–535 substituted ‘‘(a) Except as pro- vided in subsection (b), all’’ for ‘‘All’’ and ‘‘any pro- ceeding under this section’’ for ‘‘any such proceeding’’ and added subsec. (b). 1954—Act Sept. 3, 1954, struck out reference to section 654 of title 28. Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 1990 AMENDMENT Amendment by Pub. L. 101–535 effective 24 months after Nov. 8, 1990, except that such amendment effec- tive Dec. 31, 1993, with respect to dietary supplements of vitamins, minerals, herbs, or other similar nutri- tional substances, see section 10(a)(1)(C) of Pub. L. 101–535, set out as a note under section 343 of this title. CONSTRUCTION OF AMENDMENTS BY PUB. L. 101–535 Amendments by Pub. L. 101–535 not to be construed to alter authority of Secretary of Health and Human Services and Secretary of Agriculture under the Fed- eral Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), and the Egg Products Inspection Act (21 U.S.C. 1031 et seq.), see section 9 of Pub. L. 101–535, set out as a note under section 343 of this title. § 337a. Extraterritorial jurisdiction There is extraterritorial jurisdiction over any violation of this chapter relating to any article regulated under this chapter if such article was intended for import into the United States or if any act in furtherance of the violation was com- mitted in the United States. (June 25, 1938, ch. 675, § 311, as added Pub. L. 112–144, title VII, § 718, July 9, 2012, 126 Stat. 1077.) SUBCHAPTER IV—FOOD § 341. Definitions and standards for food Whenever in the judgment of the Secretary such action will promote honesty and fair deal- ing in the interest of consumers, he shall pro- mulgate 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 con- tainer. No definition and standard of identity and no standard of quality shall be established for fresh or dried fruits, fresh or dried vegeta- bles, or butter, except that definitions and standards of identity may be established for avocadoes, cantaloupes, citrus fruits, and mel- ons. In prescribing any standard of fill of con- tainer, the Secretary shall give due consider- ation 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, consider- ation shall be given and due allowance made for the differing characteristics of the several vari- eties 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 in- terest of consumers, designate the optional in- gredients which shall be named on the label. Any definition and standard of identity pre- scribed by the Secretary for avocadoes, canta- loupes, citrus fruits, or melons shall relate only to maturity and to the effects of freezing. (June 25, 1938, ch. 675, § 401, 52 Stat. 1046; Apr. 15, 1954, ch. 143, § 1, 68 Stat. 54; Aug. 1, 1956, ch. 861, § 1, 70 Stat. 919; Pub. L. 103–80, § 3(h), Aug. 13, 1993, 107 Stat. 776.) Editorial Notes AMENDMENTS 1993—Pub. L. 103–80 substituted ‘‘or reasonable stand- ards of fill of container. No definition’’ for ‘‘and/or rea- sonable standards of fill of container: Provided, That no definition’’. 1956—Act Aug. 1, 1956, designated provisions consti- tuting 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). Statutory Notes and Related Subsidiaries SAVINGS PROVISION Act Aug. 1, 1956, ch. 861, § 3, 70 Stat. 919, 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 pro- posal to issue, amend, or repeal any regulation con- templated by such section, or has been begun in accord- ance 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 imme- diately 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.’’ FOOD SAFETY AND SECURITY STRATEGY Pub. L. 107–188, title III, § 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 proc- Page 78 TITLE 21—FOOD AND DRUGS § 341 essing and manufacturing facilities and modes of trans- portation; 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, § 10807, May 13, 2002, 116 Stat. 527, provided that: ‘‘(a) ESTABLISHMENT.— ‘‘(1) IN GENERAL.—There is established a commis- sion 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 signifi- cant experience in matters under the jurisdic- tion 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 em- ployees. ‘‘(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 Commis- sion; 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 ap- pointment 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 de- scription of how each recommendation would im- prove 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 Commis- sion shall submit to the President and Congress— ‘‘(A) the findings, conclusions, and recommenda- tions of the Commission, including a description of how each recommendation would improve food safe- ty; ‘‘(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 pur- pose of carrying out this section, hold such hearings, meet and act at such times and places, take such tes- timony, 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 informa- tion 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 Com- mission to the Commission. ‘‘(ii) ADMINISTRATION.—The furnishing of infor- mation 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 indi- vidual, entity, or organization that is a party to a contract with the Commission under this sec- tion shall be considered an employee of the Commission. ‘‘(ii) PROHIBITION ON DISCLOSURE.—Information obtained by the Commission, other than informa- tion 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 Commis- sion shall serve without compensation for the serv- ices of the member on the Commission. ‘‘(B) TRAVEL EXPENSES.—A member of the Com- mission 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 Com- mission 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 en- able the Commission to perform the duties of the Commission. ‘‘(B) CONFIRMATION OF EXECUTIVE DIRECTOR.—The employment of an executive director shall be sub- ject 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 classifica- tion 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 Ex- ecutive Schedule under section 5316 of title 5, United States Code. ‘‘(3) DETAIL OF FEDERAL GOVERNMENT EMPLOYEES.— Page 79 TITLE 21—FOOD AND DRUGS § 342 1 So in original. The period probably should be ‘‘; or’’. ‘‘(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 em- ployee 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 ac- cordance 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 pre- scribed 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 appro- priated 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 ad- vance 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).’’ Executive Documents TRANSFER OF FUNCTIONS For transfer of functions of Federal Security Admin- istrator 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. 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, § 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-co- ordinated inspection, enforcement, research, and edu- cation 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 Ad- ministrator of the Environmental Protection Agency, the Assistant to the President for Science and Tech- nology/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, sci- entific, 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 recommenda- tions to the President on how to advance Federal ef- forts 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 Coun- cil shall develop a comprehensive strategic Federal food safety plan that contains specific recommenda- tions on needed changes, including measurable out- come 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, re- source, 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 par- ties, including State and local agencies, tribes, con- sumers, producers, industry, and academia. (b) Consistent with the comprehensive strategic Fed- eral 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 duplica- tion, and ensure the most effective use of resources for improving food safety. The Council shall also ensure that Federal agencies annually develop a unified budg- et 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, estab- lishes mechanisms to guide Federal research efforts to- ward the highest priority food safety needs. The JIFSR shall report to the Council on a regular basis on its ef- forts: (i) to develop a strategic plan for conducting food safety research activities consistent with the Presi- dent’s Food Safety Initiative and such other food safe- ty 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 co- operation with States, tribes, and other public and pri- vate 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 agen- cies, its officers or any person. Nothing in this order shall affect or alter the statutory responsibilities of any Federal agency charged with food safety respon- sibilities. § 342. Adulterated food A food shall be deemed to be adulterated— (a) Poisonous, insanitary, etc., ingredients (1) If it bears or contains any poisonous or del- eterious substance which may render it inju- rious to health; but in case the substance is not an added substance such food shall not be con- sidered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health.1 (2)(A) if it bears or contains any added poisonous or added deleterious substance (other than a sub- stance that is a pesticide chemical residue in or on a raw agricultural commodity or processed