Document 4JRy1M5dVZKNd2ZByq3Y9M4MR

i] ,, ft , '' n- JAT ' MAY 2 x 1973 MANUFACTURING CHEMISTS ASSOCIATION 1825 CONNECTICUT AVENUE, N.W. WASHINGTON, D. C. 20009 (202) 483-6126 May 16, 1973 To: FOOD, DRUG, AND COSMETIC CHEMICALS COMMITTEE Subject: FDA Proposal re Regulation of PriorSanctioned Food Ingredients Members: Attached is a copy of the notice which appeared in the May 15 FEDERAL REGISTER on the above subject. It says that the new Section 121.2000 General will become effective June 14. MCA comments on the proposal were sent to you October 11. We endorsed proposed Section 121.2000(b) except for omission of three procedural safeguards: 1. An opportunity to submit additional evidence to support the safety of a prior-sanctioned food ingredient prior to the publication of any proposal to alter its status, when such evidence exists. 2. An opportunity to comment on any proposal to alter the status of a prior-sanctioned food ingredient. 3. An opportunity to request a public hearing on any proposal to alter the status of a prior-sanctioned food ingre dient. The attached notice says that the first is not feasible and that FDA does not have a file of all users of prior-sanc tioned ingredients. It is suggested that anyone who has sig nificant safety information on a prior-sanctioned ingredient submit such evidence to FDA now, or as it becomes available, or as affirmation of safety is requested. The notice says further that publication of a proposal to place limitations will, in any event, provide for submission of such information. With regard to the second and third, the notice says that they are governed by the provisions of the act and the ASI 00003307 2- '"N Administrative Procedure Act, and that the Commissioner is con sidering a revision of all FDA procedural regulations which will deal with these matters with respect to all regulations under Section 701(a) of the act. Sincerely yours. MMH:gr Attachment Distribution "B" ASI 00003308 COPIED BY MCA RULES AND REGULATIONS 12737 Title 21--Food and Drugs sanctioned ingredients used in food pack CHAPTER I--FOOD AND DRUG ADMINIS TRATION, DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE SUBCHAPTER B--FOOD AND FOOD PRODUCTS PART 121--FOOD ADDITIVES aging which are in contact with food, and consequently may become an indirect adulterant of food, are not excluded from regulation under section 402 of the act. 3. Expansion of subpart E under part 121 is intended to provide a listing of all Subpart E--Prior-Sanctioned Food known prior-sanctioned food ingredients. Ingredients Whether a food ingredient is used as a A proposal was published In the Fed eral Register of August 12, 1972 (37 FR 16407) to provide for regulation of priorsanctioned ingredients by revising the title of subpart E of the food additive regulations and establishing general pro visions applicable to prior-sanctioned in gredients. Four comments were received in re sponse to this proposal. All four com ments were primarily concerned with the legality of regulating prior-sanctioned food ingredients and with providing pro cedural safeguards within the proposed regulation. Specific comments were that the exemption from food additive status of prior-sanctioned ingredients set forth in the Federal Food, Drug, and Cosmetic Act section 201 (s) (4) cannot be changed as set forth in the proposal; that absence from listing under subpart E of 21 CFR part 121 cannot afiect the prior-sanc tioned status of food ingredients; that food packaging materials employing prior-sanctioned ingredients cannot be considered food under section 402(a)(1) of the act; and that procedural safe guards permitting opportunity to submit additional evidence of safety of priorsanctioned ingredients before a proposal to change its status, and a 60-day com ment period and opportunity for public hearing, should be included in the reg ulation for any proposed or final regula tions generated from review of prior- sanctioned ingredients. Having evaluated the comments and other relevant information, the Commis sioner concludes as follows: result of a determination that it is GRAS, or pursuant to a food additive regulation, or as a result of a prior sanction, the basis for such use should be a matter of public record. Accordingly, the Food and Drug Administration will publish in this subpart all known prior-sanctioned di rect and indirect food ingredients and any subsequent limitations placed upon the use of the ingredient when scientific data justifies such limitations. It is ac knowledged that not all known priorsanctions are presently listed in this sub part. This will be remedied by publica tion of the prior-sanction status of those Ingredients supplied in response to the Food and Drug Administration's request for Information on prior sanctions (35 FR 5810) and as requests for affirmation of the safety of prior-sanctioned ingredi ents are acted upon. 4. The respondents requesting pro cedural safeguards to permit submission of additional evidence of safety prior to any Food and Drug Administration pro posal to place limitations on the use of a prior-sanctioned ingredient, is not feasi ble. The Food and Drug Administration does not have a file of all users of prior- sanctioned ingredients. It is suggested that anyone who has significant safety information on a prior-sanctioned in gredient submit such evidence to the Food and Drug Administration now, or as it becomes available to them, or as they request affirmation of the safety of the prior-sanctioned ingredients. Publication of a proposal to place limitations on the use of a prior-sanctioned ingredient will, in any event, provide for submission of 1. There is no merit to the argument such information. that prior-sanctioned food ingredients The request for other procedural safe are exempt from safety evaluation under guards, including statements that inter the adulteration provisions of the act. ested persons may comment within 60 such ingredients are poisonous or del- days upon publication of any proposal to definition of "food additive" under sec change the regulatory status of a prior- tion 201 (s) (4) of the act but are sub sanctioned ingredient and adversely ject to all the requirements of section affected persons may have a right to re 402. Subpart E, as promulgated'by this quest a hearing on any consequent final order, will incorporate the Commission order, are governed by the provisions of er's determinations with respect to the the act and the Administrative Procedure safety of prior-sanctioned ingredients in Act. The Commissioner is presently con accordance with section 402 of the act, sidering a revision of all Food and Drug 2. Section 701(a) of the act is sufficient Administration procedural regulations, legal authority to permit promulgation of which will deal with these matters with regulations determining the safety of respect to all regulations Issued under prior-sanctioned direct and indirect food section 701(a) of the act. ingredients, including a finding that any Therefore, pursuant to provisions of such ingredients are poisonous or del the Federal Food, Drug, and Cosmetic eterious adulterants of food. Prior- Act (secs. 201 (s), 409, 701(a), 52 Stat. FEDERAL REGISTER, VOL 38, NO. 93--TUESDAY, MAY IS, 1973 ASI 00003309 'JP i) ^aSjy I 12738 1055 and 72 Stat. 1784-88, as amended; 21 U.S.C. 321(b), 348, 371(a)) and under authority delegated to the Commissioner (21 CFR 2.120), subpart E of part 121 is amended as follows: 1. The title of subpart E is revised to read, ``Subpart E--Prior-Sanctioned Food Ingredients." 2. Section 121.2001 is redesignated as 5 121.2005 and a new 121.2000 is added to read as follows; 121.2000 General. (a) An ingredient whose use in food or food packaging is subject to a prior sanc tion or approval within the meaning of section 201(s) (4) of the act is exempt from classification as a food additive. The Commissioner will publish in this subpart all known prior sanctions. Any interested person may submit to the Commissioner a request for publication of a prior sanction, supported by evi dence to show that it falls within section 201 (s) (4) of the act. (b) Based upon scientific data or in formation that shows that use of a priorsanctioned food ingredient may be in jurious to health, and thus in violation of section 402 of the act, the Commis sioner will establish or amend an appli cable prior sanction regulation to impose whatever limitations or conditions are necessary for the safe use of the ingredi ent, or to prohibit use of the ingredient. Effective date.--This regulation shall become effective June 14,1973. (Secs. 201 (s), 409, 701(a), 62 Stat. 1055 ant! 72 Stat. 1784-1788, as amended: 21 U.F.C. 321 (s),348, 371(a).) Dated May 10,1973. Sam D, Fine, Associate Commissioner for Compliance. (FR Doc.73-9621 Filed 5-14-73:8:45 ami RULES AND REGULATIONS FEDERAL REGISTER, VOL. 38, NO. 93--TUESDAY MAY IS, 1973 ASI 00003310