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January 1, 2002; Updated February 19, 2004
The Secretary and, by delegation, the Assistant Secretary for the Office of Public Health and Science and the Commissioner of Food and Drugs are charged with the administration of the Federal Food, Drug, and Cosmetic Act, the Fair Packaging and Labeling Act, and provisions of the Public Health Service Act. The Food Advisory Committee is a technical and scientific committee that advises the Food and Drug Administration (FDA) in discharging its responsibilities as they relate to issues of food safety, food science, and applied nutrition, and as required, any product for which the Food and Drug Administration has regulatory responsibility.
15 USC 1451 et seq.; 21 USC 321, 341, 342, 343, 343-1, 344, 345, 346, 348, 349, 350, 350a, 351, 352, 353(f), 355, 360b, 360c-j, 371, 375, 376, 378, 379e, 381, 393, 394, 881(b); 42 USC 217a, 241, 242, 242a, 262, 264; 21 CFR Part 14, 330.10(a); the Committee is governed by the provisions of Public Law 92-463, as amended (5 USC App. 2), which sets forth standards for the formation and use of advisory committees.
The Committee shall provide advice primarily to the Director, Center for Food Safety and Applied Nutrition, and as needed to the Commissioner of Food and Drugs and other appropriate officials, on emerging food safety, food science, nutrition, and other food-related health issues that the FDA considers of primary importance for its food and cosmetics programs. The Committee may be charged with reviewing and evaluating available data and making recommendations on matters such as those relating to: (1) broad scientific and technical food or cosmetic related issues; (2) the safety of new foods and food ingredients; (3) labeling of foods and cosmetics; (4) nutrient needs and nutritional adequacy; and (5) safe exposure limits for food contaminants. The Committee may also be asked to provide advice and make recommendations on ways of communicating to the public the potential risks associated with these issues and on approaches that might be considered for addressing the issues.
The Committee shall consist of a parent committee and six subcommittees and shall have a maximum core of 59 standing members. Members and the Chairs are selected by the Commissioner or designee from among authorities knowledgeable in the fields of physical sciences, biological and life sciences, food science, risk assessment, nutrition, food technology, molecular biology, and other relevant scientific and technical disciplines. A maximum of 51 shall be standing voting members and 8 shall be standing nonvoting members.
The parent committee shall consist of 17 standing members including the Chair. Fifteen shall be voting members, of which two shall be technically qualified who are identified with consumer interests and are recommended by either a consortium of consumer- oriented organizations or other interested persons; and six of which will be the Chairs of the subcommittees identified below. In addition to the voting members, the Committee shall have two nonvoting members who are identified with industry interests.
The six subcommittees shall consist of 48 standing members, organized according to specialty areas as follows: (1) Additives and Ingredients; (2) Contaminants and Natural Toxicants; (3) Dietary Supplements; (4) Food Biotechnology; (5) Infant Formula; and (6) Nutrition. Each subcommittee will consist of eight members, including a subcommittee Chair who will also serve on the parent committee. Each subcommittee will also include a technically qualified voting member who is identified with consumer interests and is recommended by either a consortium of consumer-oriented organizations or other interested persons. In addition to the voting members, each subcommittee shall have a nonvoting member who is identified with industry interests.
The Commissioner or designee shall have the authority to select members of other scientific and technical FDA advisory committees (normally not to exceed 10 members) to serve temporarily as voting members and to designate consultants to serve temporarily as voting members when: (1) expertise is required that is not available among current voting standing members of the Committee (when additional voting members are added to the Committee to provide needed expertise, a quorum will be based on the combined total of regular and added members), or (2) to comprise a quorum when, because of unforeseen circumstances, a quorum is or will be lacking.
Members shall be invited to serve for overlapping four-year terms. Terms of more than two years are contingent upon the renewal of the Committee by appropriate action prior to its expiration.
Management and support services shall be provided by the Center for Food Safety and Applied Nutrition, Food and Drug Administration.
Meetings of the parent committee and subcommittees shall be held approximately three times a year at the call of the Chair with the advance approval of a Government official, who shall also approve the agenda. It is expected that the Subcommittees will meet not more than three times a year in between full Committee meetings. A Government official shall be present at all meetings.
Because of the size of the Committee and the variety in the types of issues that it will consider, FDA may, in connection with a particular Committee meeting, specify a quorum that is less than a majority of the current voting members. The Agency's regulations (21 CFR section 14.22(d)) authorize a Committee charter to specify quorum requirements.
Meetings shall be open to the public except as determined otherwise by the Commissioner or designee. Notice of all meetings shall be given to the public.
Meetings shall be conducted and records of the proceedings kept as required by applicable laws and Departmental regulations.
Members who are not full-time Federal employees shall be paid at the rate of the General Schedule 15, step 10, plus per diem and travel expenses in accordance with Standard Government Travel Regulations.
The estimated annual cost of operating the Committee, including compensation and travel expenses for members but excluding staff support, is $681,458.00. The estimated person- years of staff support are 5.5, at an estimated annual cost of $520,827.
In the event that a portion of a meeting is closed to the public, a report shall be prepared not later than November 1 of each year which contains at a minimum the function of the Committee, a list of members and their business addresses, the dates and places of meetings, and a summary of the Committee's activities and recommendations during the preceding year. A copy of the report shall be provided to the Department Committee Management Officer.
Unless renewed by appropriate action prior to its expiration, the Food Advisory Committee will terminate on December 18, 2005.
Approved:
_____________________________
Peter J. Pitts
Associate Commissioner for External Relations
Food and Drug Administration
________________
Date
I determine that renewal of the Food Advisory Committee beyond December 18, 2003, is in the public interest in connection with the performance of duties imposed on the Food and Drug Administration by law, that such duties can best be performed through the advice and counsel of such a group. Therefore, the Committee is continued until December 18, 2005.
I deem that it is not feasible for the Food and Drug Administration or any of its existing committees to perform these duties, and that a satisfactory plan for appropriate balance of committee membership has been submitted.
_____________________________
Peter J. Pitts
Associate Commissioner for External Relations
Food and Drug Administration
________________
Date
The Committee shall consist of a parent committee and six subcommittees and shall have a maximum core of 59 standing members. Members and the Chairs are selected by the Commissioner or designee from among authorities knowledgeable in the fields of physical sciences, biological and life sciences, food science, risk assessment, nutrition, food technology, molecular biology, and other relevant scientific and technical disciplines. A maximum of 51 shall be standing voting members and 6 shall be standing nonvoting members.
The parent committee shall consist of 17 standing members including the Chair. Fifteen shall be voting members, of which two shall be technically qualified who are identified with consumer interests and are recommended by either a consortium of consumer-oriented organizations or other interested persons; and six of which will be the Chairs of the subcommittees identified below. In addition to the voting members, the Committee shall have two nonvoting members who are identified with industry interests.
The six subcommittees shall consist of 48 standing members, organized according to specialty areas as follows: (1) Additives and Ingredients; (2) Contaminants and Natural Toxicants; (3) Dietary Supplements; (4) Food Biotechnology; (5) Infant Formula; and (6) Nutrition. Each subcommittee will consist of eight members, including a subcommittee Chair who will also serve on the parent committee. Each subcommittee will also include a technically qualified voting member who is identified with consumer interests and is recommended by either a consortium of consumer-oriented organizations or other interested persons. In addition to the voting members, each subcommittee shall have a nonvoting member who is identified with industry interests.
The Food and Drug Administration will give close attention to equitable geographic distribution and to minority and female representation so long as the effectiveness of the Committee is not impaired.
Appointments shall be made without discrimination on the basis of age, race, gender, sexual orientation, HIV status, and cultural, religious, or socioeconomic status.
This committee is authorized by Title III of the FDA Revitalization Act (Pub. L. 101-635) (21 U.S.C. 394). The citations in the committee charter reflect that authority as well as the program authority from the Federal Food, Drug and Cosmetic Act (21 U.S.C. 355).
This charter also includes citations from the Public Health service Act (42 U.S.C. 217a, 241) which authorize FDA to use multi-year appointment authority for members.
The program and legislative authorities for this committee consist of approximately 25 to 30 pages and are therefore not included in this submission.
