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MANUFACTURING CHEMISTS ASSOCIATION 1825 CONNECTICUT AVENUE. N W. WASHINGTON, D. C. 20009 * (202) 483-6126 January 20, 1971 GRC-19-1 MINUTES GOVERNMENT RELATIONS COMMITTEE EXECUTIVE CHAMBER NUMBER THREE THE MADISON HOTEL 15TH AND M STREETS, N.W. WASHINGTON, D.C. JANUARY 18, 1971 PRESENT Myron V. Anthony j. Warden Cunningham Kimball Firestone Francis D. Flanagan Don A. Goodall Richard M. Hunt J. J. Kenney (for Morse Dial) Frederick B. Lee Wilbur C. Lowrey Mike Manatos Charles T. Marck Donald O. Opstad Lester G. Shapiro Carstens Slack James G. Morton, Director Government Relations Hugh M. Robinson David C. Williams William M. Stover, Secretary Brian D. Forrow (guest) ABSENT Carroll W. Hayes, Chairman Sam Pickard, Vice Chairman E. Bruce Harrison Robert F. Kelly Stauffer Chemical Company Air Reduction Company, Inc. Firestone Tire & Rubber Company W. R. Grace & Co. American Cyanamid Company National Lead Company Union Carbide Corporation Olin Corporation Shell Chemical Company The Procter & Gamble Mfg. Company The Dow Chemical Company 3M Company Engelhard Minerals & Chemicals Corp. Phillips Petroleum Company Manufacturing Chemists Association Manufacturing Chemists Association Manufacturing Chemists Association Manufacturing Chemists Association Allied Chemical Corporation Celanese Corporation Monsanto Company Freeport Sulphur Company E. I. du Pont de Nemours & Company ASI 00002753 vliam j drived rnssiptNT MANUFACTURING CHEMISTS ASSOCIATION 1825 CONNECTICUT AVENUE. N. W. WASHINGTON. D C. 20009 (202) 483-8128 January 21, 1971 Hearing Clerk Department of Health, Education, and Welfare 5600 Fishers Lane Rockville, Maryland 20852 Dear Sir: The Manufacturing Chemists Association submits the follow ing comments in reply to the Notice of Proposed Rule Making which appeared on pages 18623 and 18624 of the December 8, 1970 Federal Register under the heading "Eligibility of Substances for Classification as Generally Recognized as Safe in Food." The Manufacturing Chemists Association is a nonprofit trade association of 173 United States company members repre senting more than 90% of the production capacity of basic industrial chemicals within this country. Qualified Experts The proposed rule making, as we understand it, implies that determination of GRAS should be the unilateral decision of FDA. However, under the statute, the responsibility for such a decision is not so limited. Rather, such decision must reflect the opinion of qualified experts both within and without FDA. Consequently, we feel it should be made clear that the proposed regulation is interpretive only, and merely reflects the agency's opinion as to what substances are generally rec ognized by qualified experts as safe for food use. For the same reason, we also see no justification for the implication that in certain cases GRAS promulgation is "required," as stated in proposed Section 121.3(b) (2). In order to eliminate any possible ambiguity as to FDA's role in the GRAS status question, we suggest the addition of the following sentence to proposed Section 121.3(a): ASX 00002754 Hearing Clerk January 21, 1971 Page Two "Of course, where a substance has been generally recognized as safe by qualified experts, its GRAS status may be affirmed by FDA as proposed herein." For additional clarification, proposed Section 121.3(b)(1) should be written as "for which no affirmation by FDA is neces sary" instead of "for which no promulgation is required.'* New Use of GRAS Substance Proposed Section 123.3(b)(3)(i) provides that any food substance intended for human consumption which has no history of safe use under the proposed conditions is not eligible for GRAS listing and therefore requires a food additive regulation. We are in firm agreement with the principle that sub stances without any history of safe use can be cleared only through an appropriate food additive regulation. However, the language of this section would recognize no possibility of GRAS acceptance for a new use of a substance already recognized as GRAS for established uses, regardless of the new usage level proposed and regardless of the opinion that qualified experts might have concerning the safety of the proposed new use. While we concur that any new use of a food substance, even a GRAS sub stance, should be carefully reviewed, we feel that it would b needlessly restrictive and improper to require that all such new applications be cleared via a food additive regulation. The effect of this section in its present form would be to arbitrar ily fix the GRAS list, thus preventing extension of GRAS cover age to new usages for traditionally GRAS substances. We therefore propose that the language in proposed Section 121.3(b)(3)(i) be modified in such way as to permit the ext nsion of GRAS coverage to new applications of GRAS substances, providing qualified experts consider such new applications to be GRAS. Total Intake Limitations Under the proposed Section 121.3(b) (3) (ii), a substance would not be eligible for inclusion as GRAS if "total intake ASI 00002755 Hearing Clerk January 21, 1971 Page Two "Of course, where a substance has been generally recognized as safe by qualified experts, its GRAS status may be affirmed by FDA as proposed herein." For additional clarification, proposed Section 121.3(b)(1) should be written as "for which no affirmation by FDA is neces sary" instead of "for which no promulgation is required." New Use of GRAS Substance Proposed Section 123.3 (b) (3) (i) provides that any food substance intended for human consumption which has no history of safe use under the proposed conditions is not eligible for GRAS listing and therefore requires a food additive regulation. We are in firm agreement with the principle that sub stances without any history of safe use can be cleared only through an appropriate food additive regulation. However, the language of this section would recognize no possibility of GRAS acceptance for a new use of a substance already recognized as GRAS for established uses, regardless of the new usage level proposed and regardless of the opinion that qualified experts might have concerning the safety of the proposed new use. While we concur that any new use of a food substance, even a GRAS sub stance, should be carefully reviewed, we feel that it would be needlessly restrictive and improper to require that all such new applications be cleared via a food additive regulation. The effect of this section in its present form would be to arbitrar ily fix the GRAS list, thus preventing extension of GRAS cover age to new usages for traditionally GRAS substances. We therefore propose that the language in proposed Section 121.3(b) (3) (i) be modified in such way as to permit the exten sion of GRAS coverage to new applications of GRAS substances, providing qualified experts consider such new applications to be GRAS. Total Intake Limitations Under the proposed Section 121.3(b) (3) (ii), a substance would not be eligible for inclusion as GRAS if "total intake ASI 00002755 Hearing Clerk January 21, 1971 Page Three limitations must be imposed to assure safe use." Wo do not question the desirability of establishing total intake limits where necessary to assure safety. However, where such an intake limit is established for a particular substance, we do question the conclusion that such substance should automatically be ineligible for GRAS status under any level of use below such intake limit. A conclusion such as this would seem to be in direct conflict with the definition of food additive in Section 201(s) of the statute, which ex cepts a substance that may be GRAS by qualified experts under the conditions of its intended use (emphasis added). The term "under conditions of its intended use" would seem to authorize a conclusion by qualified experts as to the GRAS status of a substance, which under the conditions of its use would be added to a food in an amount below an established total intake level. Therefore, since the proposed Section 121.3(b)(3)(ii) and Section 201 (s) of the statute seem to be in conflict on this question, we suggest that this proposed section be deleted with decisions in this area being resolved on a case-by-case basis in a manner consistent with the statute. Processing Proposed Section 121.3(b) (1) (ii) provides that any food substance which is acceptable as GRAS without formal listing, under basic criteria set forth in Section 121.3(b) (1) (i), will also be accepted when "... modified by conventional processing" which is in accord with current good manufacturing practices. However, the only guidance provided as to what processing will be considered "conventional" is found in Section 121.3 (b) (2) (i) . This section, in effect, stipulates that food substances other wise considered GRAS without formal listing will require "in dividual review of pertinent data" in order to qualify for formal GRAS listing if they have been modified by processes introduced after January 1, 1958. We are seriously concerned over this introduction of processing procedures as a criterion of GRAS status in a way which is, in our opinion, completely arbitrary. In short, the date at which a processing technique is introduced has nothing ASX 00002756 Hearing Clerk January 21, 1971 Page Four whatever to do with the safety of the food substance involved. The influence of a processing procedure on the GRAS status of a food substance must be assessed based upon the fundamentals of the processing. The key question is whether or not a proc essing method alters the composition of a food substance in such a manner as to adversely affect its safety. Under the present wording of these sections of the proposal, food substances processed into a unique physical form by freeze drying (a process which has relatively recently come into com mercial use) could be disqualified from their inherent GRAS status merely because they had been prepared by a process introduced since January 1, 1958. Furthermore, future changes in traditional processes, such as new procedures for size classification of wheat flour fractions, could foreclose historically accepted food sub stances from their traditional GRAS status. This would have the effect of discouraging otherwise desirable technological advances. We therefore strongly urge that proposed Section 123.3(b) (2) (i) be deleted, and proposed Section 121.3(b) (1) (ii) be' revised to recognize the general principle that any processing applied to a food substance must not adversely affect its safety. Prior Announcement We note that the portion of the proposal pertaining to Section 121.3(d) makes no provision for prior announcement of a change of status or a statement of reasons therefor. However, Section 121.3 as now in effect does provide for such notice. For this reason we would propose that the last sentence of proposed Section 121.3(d) be revised to provide that "no status change will be made without prior announcement and a statement of reasons therefor." Sincerely ASI 00002757