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Adulterated Food Entific, and Industry Groups, As Appropriate Page 71 TITLE 21—FOOD AND DRUGS § 342 ‘‘(f) TERMINATION.—The Commission shall terminate (c) The Council shall ensure that the Joint Institute on the date that is 60 days after the date on which the for Food Safety Research (JIFSR), in consultation with Commission submits the recommendations and report the National Science and Technology Council, estab- under subsection (b)(3).’’ lishes mechanisms to guide Federal research efforts to- ward the highest priority food safety needs. The JIFSR EX. ORD. NO. 13100. PRESIDENT’S COUNCIL ON FOOD shall report to the Council on a regular basis on its ef- SAFETY forts: (i) to develop a strategic plan for conducting food Ex. Ord. No. 13100, Aug. 25, 1998, 63 F.R. 45661, as safety research activities consistent with the Presi- amended by Ex. Ord. No. 13286, § 16, Feb. 28, 2003, 68 F.R. dent’s Food Safety Initiative and such other food safe- 10623, provided: ty activities as the JIFSR determines appropriate; and By the authority vested in me as President by the (ii) to coordinate efficiently, within the executive Constitution and the laws of the United States of branch and with the private sector and academia, all America, and in order to improve the safety of the food Federal food safety research. supply through science-based regulation and well-coor- SEC. 4. Cooperation. All actions taken by the Council dinated inspection, enforcement, research, and edu- shall, as appropriate, promote partnerships and co- cation programs, it is hereby ordered as follows: operation with States, tribes, and other public and pri- SECTION 1. Establishment of President’s Council on Food vate sector efforts wherever possible to improve the Safety. (a) There is established the President’s Council safety of the food supply. on Food Safety (‘‘Council’’). The Council shall comprise SEC. 5. General Provisions. This order is intended only the Secretaries of Agriculture, Commerce, Health and to improve the internal management of the executive Human Services, and Homeland Security, the Director branch and is not intended to, nor does it, create any of the Office of Management and Budget (OMB), the Ad- right or benefit, substantive or procedural, enforceable ministrator of the Environmental Protection Agency, at law by a party against the United States, its agen- the Assistant to the President for Science and Tech- cies, its officers or any person. Nothing in this order nology/Director of the Office of Science and Technology shall affect or alter the statutory responsibilities of Policy, the Assistant to the President for Domestic any Federal agency charged with food safety respon- Policy, and the Director of the National Partnership sibilities. for Reinventing Government. The Council shall consult with other Federal agencies and State, local, and tribal government agencies, and consumer, producer, sci- § 342. Adulterated food entific, and industry groups, as appropriate. (b) The Secretaries of Agriculture and of Health and A food shall be deemed to be adulterated— Human Services and the Assistant to the President for Science and Technology/Director of the Office of (a) Poisonous, insanitary, etc., ingredients Science and Technology Policy shall serve as Joint (1) If it bears or contains any poisonous or del- Chairs of the Council. SEC. 2. Purpose. The purpose of the Council shall be to eterious substance which may render it injuri- develop a comprehensive strategic plan for Federal food ous to health; but in case the substance is not safety activities, taking into consideration the findings an added substance such food shall not be con- and recommendations of the National Academy of Sci- sidered adulterated under this clause if the ences report ‘‘Ensuring Safe Food from Production to quantity of such substance in such food does not Consumption’’ and other input from the public on how ordinarily render it injurious to health.1 (2)(A) if to improve the effectiveness of the current food safety it bears or contains any added poisonous or system. The Council shall make recommendations to the President on how to advance Federal efforts to im- added deleterious substance (other than a sub- plement a comprehensive science-based strategy to im- stance that is a pesticide chemical residue in or prove the safety of the food supply and to enhance co- on a raw agricultural commodity or processed ordination among Federal agencies, State, local, and food, a food additive, a color additive, or a new tribal governments, and the private sector. The Council animal drug) that is unsafe within the meaning shall advise Federal agencies in setting priority areas of section 346 of this title; or (B) if it bears or for investment in food safety. contains a pesticide chemical residue that is un- EC Specific Activities and Functions S . 3. (a) The Coun- safe within the meaning of section 346a(a) of this cil shall develop a comprehensive strategic Federal food safety plan that contains specific recommenda- title; or (C) if it is or if it bears or contains (i) tions on needed changes, including measurable out- any food additive that is unsafe within the come goals. The principal goal of the plan should be the meaning of section 348 of this title; or (ii) a new establishment of a seamless, science-based food safety animal drug (or conversion product thereof) that system. The plan should address the steps necessary to is unsafe within the meaning of section 360b of achieve this goal, including the key public health, re- this title; or (3) if it consists in whole or in part source, and management issues regarding food safety. of any filthy, putrid, or decomposed substance, The planning process should consider both short-term or if it is otherwise unfit for food; or (4) if it has and long-term issues including new and emerging threats and the special needs of vulnerable populations been prepared, packed, or held under insanitary such as children and the elderly. In developing this conditions whereby it may have become con- plan, the Council shall consult with all interested par- taminated with filth, or whereby it may have ties, including State and local agencies, tribes, con- been rendered injurious to health; or (5) if it is, sumers, producers, industry, and academia. in whole or in part, the product of a diseased (b) Consistent with the comprehensive strategic Fed- animal or of an animal which has died otherwise eral food safety plan described in section 3(a) of this than by slaughter; or (6) if its container is com- order, the Council shall advise agencies of priority areas for investment in food safety and ensure that posed, in whole or in part, of any poisonous or Federal agencies annually develop coordinated food deleterious substance which may render the con- safety budgets for submission to the OMB that sustain tents injurious to health; or (7) if it has been in- and strengthen existing capacities, eliminate duplica- tentionally subjected to radiation, unless the tion, and ensure the most effective use of resources for use of the radiation was in conformity with a improving food safety. The Council shall also ensure regulation or exemption in effect pursuant to that Federal agencies annually develop a unified budg- section 348 of this title. et for submission to the OMB for the President’s Food Safety Initiative and such other food safety issues as the Council determines appropriate. 1 So in original. The period probably should be ‘‘; or’’. § 342 TITLE 21—FOOD AND DRUGS Page 72 (b) Absence, substitution, or addition of constitu- (ii) if no conditions of use are suggested or ents recommended in the labeling, under ordi- (1) If any valuable constituent has been in nary conditions of use; whole or in part omitted or abstracted there- (B) is a new dietary ingredient for which from; or (2) if any substance has been sub- there is inadequate information to provide stituted wholly or in part therefor; or (3) if dam- reasonable assurance that such ingredient age or inferiority has been concealed in any does not present a significant or unreasonable manner; or (4) if any substance has been added risk of illness or injury; thereto or mixed or packed therewith so as to (C) the Secretary declares to pose an immi- increase its bulk or weight, or reduce its quality nent hazard to public health or safety, except or strength, or make it appear better or of that the authority to make such declaration greater value than it is. shall not be delegated and the Secretary shall (c) Color additives promptly after such a declaration initiate a proceeding in accordance with sections 554 and If it is, or it bears or contains, a color additive 556 of title 5 to affirm or withdraw the declara- which is unsafe within the meaning of section tion; or 379e(a) of this title. (D) is or contains a dietary ingredient that (d) Confectionery containing alcohol or non- renders it adulterated under paragraph (a)(1) nutritive substance under the conditions of use recommended or If it is confectionery, and— suggested in the labeling of such dietary sup- (1) has partially or completely imbedded plement. therein any nonnutritive object, except that In any proceeding under this subparagraph, the this subparagraph shall not apply in the case United States shall bear the burden of proof on of any nonnutritive object if, in the judgment each element to show that a dietary supplement of the Secretary as provided by regulations, is adulterated. The court shall decide any issue such object is of practical functional value to under this paragraph on a de novo basis. the confectionery product and would not (2) Before the Secretary may report to a render the product injurious or hazardous to United States attorney a violation of para- health; graph 2 (1)(A) for a civil proceeding, the person (2) bears or contains any alcohol other than against whom such proceeding would be initi- alcohol not in excess of one-half of 1 per cen- ated shall be given appropriate notice and the tum by volume derived solely from the use of opportunity to present views, orally and in writ- flavoring extracts, except that this clause ing, at least 10 days before such notice, with re- shall not apply to confectionery which is in- gard to such proceeding.
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