Document 7Mvq1wwQ3jDRBJE7xgmonog9V

JOSEPH E. KELLER JEBOME H HECKMAN CHABLKS M MEEHAN WILLIAM H BORGHBSANI, JR. ROBERT R.TTEBNAX WAYNE V BLACK DAVID L- HILL MARTIN W BERCOVTCI MARC K SHAVE LELAND J BLAIR PETER M.NEMROV LAV OFFICES Kelleh and Heckman tiao ITT* STREET, N. W. SUITE lOOO WASHINGTON, D C. 20036 September 1, 1972 Dr. Karl A. Hochschwender American Hoechst Corporation Route 202-206 North, Bridgewater P. 0. Box 2500 Somerville, New Jersey 08876 TELEPHONE ftoa see*shoo CABLE ADDRESS SEL>QN ' Re: FDA Proposed Rule Making Regarding Environmental Impact Statements (37 Fed. Reg. No. 134, page 13636 et. seq.); Nelson Bills (S.76 and S.3163 Hearings) Dear Karl: The purposes of this letter are (1) to follow up on that portion of our July 14, 1972 letter re lating to the referenced FDA rule making proceeding, and (2) to at least advise you and the others on our Food, Drug and Cosmetic Packaging Materials Committee about the Hearings Senator Nelson is now expected to hold soon relative to pending legislation which could broaden the kind of testing and clearance require ments already proven so burdensome under the Food Additives Amendment of 1958. Taking the Environmental Impact Statement matter first, not unexpectedly, we received only one formal Comment from a member of our Committee and that came in the form of a very welcome letter from George Richter who was good enough to supply us with Comments on the proposal Rohm & Haas decided to file directly with FDA. Under the circumstances, we de cided to forego the filing of Comments on SPI's be half. This decision was in keeping with the obervation I made in the July 14 letter to the following effect: "Frankly, I have some doubt as to whether any meaningful Comments can be submitted on this proposal in jy, ASI-PR 0001285 Dr. Karl A. Hochschwender September 1, 1972 Page Two light of the fact that it pretty much amounts to an FDA move to quell consumer interest criticism of its alleged failure to comply with the National Environmental Policy Act. Furthermore, our im mediate reaction is that there is little that is subject to valid criticism in the proposal." I still feel that the Food and Drug Administra tion really has no choice other than to indicate it may require Environmental Impact Statements in appro priate circumstances since another governing Statute is involved. For your information, however, we thought we would supply each member of the Committee with a reproduction of George Richter's Comments. Obviously, and as I have now advised George during a telephone conversation, we are in sympathy with his objectives but have serious doubt that his proposal will be accommodated. We agree that the Food Additives Amendment should not be used as a means for opening broad environmental impact questions since this was never intended by its authors. On the other hand, there can be no question but that the National Environ mental Policy Act was designed to force all of the Agencies to superimpose its requirements on existing statutory law. This being the case, we have little doubt but that FDA will ultimately finalize its proposal in some form. Moreover, our suspicion is that this action is likely to affect indirect additives even more than direct additives because of the general controversy over the solid waste problem. Indeed, my own feeling is that FDA will reluctantly be thrust into the midst of the solid waste debacle because it does have the power to regulate indirect additives. This is why I feel there is little chance that it will exempt indirect additives from the Environmental Impact Statement concept. About the only note of optimism that can be mentioned in this connection is the fact that per haps it will be somewhat better if a petitioner is ASI-PR 0001286 Dr. Karl A. Hochschwender September 1, 1972 Page Three required to submit the basic data for an Environmental Impact Statement openly, as FDA has proposed, than if the Agency were required to prepare such Statements on its own (at least in theory); solicited the data necessary from the petitioner, as would be the only practical course of action open to it; and then both the Agency and the petitioner were subjected to dem agogic type criticism for cooperating. Unfortunately, in connection with the PVC liquor bottle question with which many of you are familiar, the Bureau of Alcohol, Tobacco and Firearms and SPI have been criticized for working together. Those who have voiced the criticism have made it seem as if there was something evil about our supplying necessary and requested information. Obviously, at least this psychological disadvantage will not have to be suffered if and when the FDA proposal becomes effective. Finally, while writing to report to you on this matter, we thought we would take this opportunity to let everyone know that Senator Gaylord Nelson has now scheduled a three day Hearing of the Select Com mittee on Nutrition and Human Needs of the Senate to consider his Bills, and others, that could impose even more stringent food additives controls, i.e. (1) the extension of the Delaney clause so that proof of no adverse mutagenicity, or teratological possibilities, as well as no known carcinogenicity, would have to precede clearance of all food additives, and (2) the outright abolition of the entire "generally recognized as safe (GRAS)" concept so that all present GRAS (and probably "prior sanctioned") substances could pre sumably have to be cleared by new Petitions and Food Additive Regulations. We doubt that the Nelson Hearings will lead to any immediate new legislation but they could pro vide a forum for an interesting debate about the Delaney clause in general. We would therefore recom mend that all interested parties consider staying abreast of what takes place when the Hearings are ASI-pp 00l287 Dr. Karl A. Hochschwender September 1, 1972 Page Four held from September 18 to September 20. I am sure that Food Chemical News will be covering the pro ceedings. If anything of direct interest develops, we will also report to you appropriately. If you have questions about any of the matters covered in this letter, please do not hesitate to let me know. Enclosure cc: SPI Food, Drug and Cosmetic Packaging Materials Committee ASI-PR 0001288 INDEPENDENCE MALL WEST, PHILADELPHIA, PA. 19105 TELEPHONE (215) 592-3000 August 14, 1972 A ROHM SHRRS COMPANY Jerome H. Heckman, Esq. Keller and Heckman 1150 17th Street, N. W. Suite 1000 Washington, D. C. 20036 Dear Jerry: For your Information, enclosed Is a letter to the Hearing Clerk regarding the environmental impact state ment amendment recently proposed by the FDA in which we request that an exception be made for petitions concerned with Subpart F of the food additive regulations. There may be little chance of obtaining favorable action, but we feel that there is nothing to be lost in expressing our objection. If you can think of other arguments, or in any case, you may wish to consider raising a similar objection on behalf of SPI. Cordially, GAR:jm Enc. G. A. Richter, Jr. ASI-PR 0001289 August IX, 1972 Hearing Clerk Department of Health, hducation and Welfare iioos 6-63 5<Cd Fishers lar.a Rockville, lid. 30852 Sir: Re: Proposed Amendment of Title 21, Chapter I by Addition of Hew Part 6 The purpose of this letter is 1) to express objection to the requirement In the subject proposal that '-aviromaental log act analysis reports bo submitted to the !'ood and Drug Adr iniatration cs support for petitions to c'ct indirect fewd additives under hubpart F of the food additive regulatit ns and 2) to recommend a modification cf *`.no proposal which la consistent with this objection. Our reasons for th: a action are as follows: 1. Su> part F of the food additive regulations in concerned wii h food additives resulting from contact with containers r or equipment, '.here la no intention to add outstarves to fo< d. Therefore it can be reasonably ttoausieb that inadv ; tent additions (o.g., as a rooult of migration 1rom packaging materials) would be insignificant with raped to environmental impact. 2. It is extremely unlikely that a product bein ' consi iered for use in contact with food would be manufactured only f uses which arc ouhject to the food additive retulations. It can safely be assured that conponer.to of packaging ma erials would be manufactured for uses other than foodcontact regardless of whether or not such component- becor-v. d ared under a food additive regulation. Thus, tt.j impact on the environment resulting from the manufacture or a p ;ential indirect food additive would not bo significantly af 'acted by ita clearance under a food additive regulation In Subpart P. it- As i- PR 00i290 ^* ", ',Besni vj-or* ;;,f * Department of Health, Education and W Ifare -2- 3. Tie cnly reasonable question of safety relating to the use of ar- indirect additive is the toxi ologieal effect on our fcod 3upply. Under existing proced res, the toxioological risk from demonstrated migration of each food additive to tae Jood supply must be carefully d curaented and oonsidored before a petition for u regulation r amendment under Euhpart F of the food additive regu ation3 is. promulgated. The proposed amendment includes in aragraph (c) of Section 6.1 the following statement '`An environnentnl impact statement rill not be required for amendments to existing regulations md appro', a Is of supple- ` ci nts to existing approvals unless .he change Is substantial." In view of this statement and of t; 3 arguments presented above, we contend that neither new regulations nor amend ments to existing regulations unde SUbpart l- of 21 CFR Part 121 are reasonably expected t cause significant environmental impact. We therefor request ;;hat the proposed procedural amendment be amended as follows: a) Add to the list of agency actio; s for which environmental impact statements are not required (under paragraph (d) of Section 6.1) an item which reads " ssuance or amendment of food additive regulations under 21 CFR Part 121 Subpart F." b) Modify subparagraph (b) (11) of Section 6,1 to road "Approval of food additive petitions except for new regula tions or amendments to existing regulations under 21 CFR Part 121 Subpart F." o) In Part 121, modify item H under paragraph (c) of Section 121.51 to read "Except for petitions for regulations or amendments under Subpart F, the petitioner is required to submit an environmental impact analysis report analyzing the mironmental impact of the manufacturing process and the ultimate use or consumption of thr food additive pursuant to Section 6.1 of this chapter." We feel strongly that the abosve modification of the proposed procedural amendment would be in the public interest since it would eliminate unnecessary and meaningless effort on the part of industry and government without creating a threat to the environment. cc: Jerome H. Heckman, Esq. Dr. Karl A. Hochschwender QARjJm ^ery truly yours, cj A K ASI-PR 0001291 <3. A. Richter, Jr. Administrative Assistant, Government Relations