Document 1g8oZ5bXnO4j6K1LJGaRVR8nq

r- y JOSEPH E. K.ELLEH JEROME H. KECKMAK CHARLES M. MEEHAN WILLIAM H. BOBOHESANI. JE. BOBEBT R. TXERNAX wayne v. black David l. hill MARTIN W. BEBCOVICI PETER M, WEKEOV JOSEPH E. HADLEY CAROLS C. HARRIS PETER THOMAS SMITH MICHAEL F. MOBKONE LARRY S- SOLOMON ` -* LAW OFFICES Kelleb a2tx Heckman 1130 ITES STREET, N. W. SUITE lOOO WASHINGTON, It. C. 20036 March 9, 1976 ' No. 17- iMAR 5 1976 TELEPHONE 208 204-2100 CAJOLE ADDRESS "KELKAN" TO: All Members of PVC/VCM Mailing Lists Ladies and Gentlemen: Once again we are writing to bring you up-to-date on regulatory and related activities dealing with vinyl, chloride and polyvinyl chloride; . For the most part/ this' report focuses on Food and Drug Administration (FDA) matters but we are also including a reminder regarding the Occupa tional Safety and Health Administration (OSHA) Standard, and some general information we believe will be of interest. FDA Many of you will recall our earlier report that the target date for the final FDA Regulations concerning polyvinyl chloride had been moved up from the last quarter of 1976. As a result of our most recent contacts with FDA personnel, we can now advise that the present target is action "before June 30, 1976." Since the technical review of the various submissions has, we understand, not yet been completed, and because this review is a necessary prerequi site for the development of any.sound.Regulation, it seems unlikely that final Regulations will be promulgated much before the end of June. Furthermore, we understand that no conclusions have yet been reached regarding the EPA-FDA jurisdictional issue regarding PVC pipe. As a possible clue to present FDA thinking, we think it may be of significance to note that the Federal Register see 1-0160 March 9, 1976 Page Two r>- N. for Friday, March 5, 1976 included two Food Additive Regu lations covering applications for polyvinyl chloride plastics (copies enclosed). One Regulation results in an amendment to Section 121.2514 (Resinous and polymeric coatings) which' permits use of a new vinyl chloride copolymer? the second establishes a-^new Section 121.2634 and provides for the use of an ultra filtration membrane based, in part, on a vinyl * chloride-acrylonitrile copolymer. These new Regulations are of interest because both preambles refer to the September 3, 1975 proposed rulemaking and reaffirm some of the positions set forth in the proposals. Thus, the coating Regulation preamble notes that the proposed PVC Regulation would exempt coatings from the prohibition for the use of vinyl chloride homopolymers and copolymers ? consequently, the new material was deemed "approvable". Somewhat similarly, the preamble to the ultra filtration membrane Regulation noted the Food and Drug Ad ministration^ conclusion that the product was similar to the microporous polymeric filters already regulated in Section 121.2631, products which were described in the September 3 proposal as presenting no problem. In addition, however, this preamble also notes that the vinyl chloride resin used to produce the membranes has a residual VC level of less than 1.5 ppm and states that the subsequent production of the membranes and pre-use treatment results "in a reduction of any remaining vinyl chloride to the point that the Commissioner concludes that the use of the ultra filtration membranes would not reasonably be expected to result in vinyl chloride be coming a component of food." It seems to us that this latter comment is of par ticular interest for two reasons. Firstly, it constitutes some recognition that products made with resins containing 1.5 ppm of residual monomer can be processed .into final products that meet the statutory criterion of "no reasonable expectation of migration". Secondly, this preamble and the preamble for the coating amendment both reaffirm that PVC products can be used in food contact applications provided there is no reasonable expectation that vinyl chloride will migrate to food. .In other words, the Food and Drug Adminis tration has, in effect, reaffirmed in two newly final see 1-014*1 March 9r. 1976 Page Three Regulations the underlying basis for important parts of its September 3, 1975 proposals, i.e. no reasonable expectation of migration of vinyl chloride to food is a sound basis for permitting the use of PVC plastics. . OSHA - April 1, 1976 is, as many of you are aware, the date on which the OSHA Standard for Vinyl Chloride becomes fully operative. In other words, beginning April 1, 1976 the requirement for the use of respirators when exposure exceeds the permitted levels but does not exceed 25 parts per million will no longer be optional with the employee but will be mandatory. The "rumor mill" indicates that some manufac turers may be requesting a postponement of this effective date, but we have initiated no inquiries in this regard so as to avoid inadvertently prejudicing any individual company action. If any such requests have been made or are anticipated, and those making them wish to inform us, we would appreciate being so advised and will, if requested, notify others in the industry by means of another letter such as this one. General Of some general interest is a report on the symposium held jointly by the National Institute of Environmental Health Sciences (NIEHS) and the World Health Organization (WHO), an organ of the United Nations, last week. The symposium was held on March 1-3, 1976 to consider potential health hazards in the rubber and plastics industries. Dr. Dixler of our office attended this symposium and we are enclosing a copy of that portion of his report that relates to vinyl chloride and polyvinyl chloride. We think it-is somewhat reassuring to learn that no new health or environmental problems related to vinyl chloride exposure have been reported. However, we. are also enclosing a copy of a New York Times article which reports a study now being conducted by the National Center for Disease Control. It concerns a possible link between birth defects in the South Charleston, West Virginia area where a PVC plant has long been located. ** * see 1-0162 March 9, 1976 Page Four As in the past, we shall continue to follow closely governmental and related activities concerning vinyl chloride and polyvinyl chloride so-we can report on them to you promptly- Cordially yours, Enclosures see 1-0163 RULES and regulations O%f/Ot -!L 'ompllsh their purpose la the public therefrom a dry, free-fl< DocV<L No.76F--0015] . ::rest. It does not appear that public .trticipation in the rulemaking proceed" - would make additional relevant ln- ittion available to the Department. According I.*. under the administrative 'ocedure provisions in 5 U.S.C. 553. it '<.und upon good cause that notice nd other public procedure with respect it the amendments are impracticable .d contrary to the public Interest, and .njd cause (ls found for making them dectlve leas than 30 days after publlca,m in<the Federal Register. L>one at Washington, D.C., this 2d day c March. 1976. ' N ' J. M. Hejl. Deputy Administrator, Veterinary Services. JFB Doc.76-6345 Filed 3-4-7^6^45 am| Title 21--Food and Drugs follows: (llAn'aQueous blend of soybean and sunflower meals in a ratio of 3:i. respec- t, Is mixed with animal fat such that oilseed meals and animal fat are in a ratio of 3:2. The feed ingredients are se defined by the "Official Publica- tiofVi of the Association of American Feed^Kontrol Officials, Inc.. 1976 ed.. pages 867SQ, and 109.1 (2) Formaldehyde <37. percent solu tion) is added tlKttie mixture at a level of 4 percent of theH^ matter weight of the oilseed meals ancNmimal fat. This mixture, upon drying, cobtalns not more than 1 percent formaldehyde and not more than 12 percent molsturi (b) The dried mixture described in paragraph (a) of this section is'psed, or intended for use, as a component\of dry, nonpelleted feeds for beef and nonlactat ing dairy cattle. t PART 121--rFOOD ADDITIVES------ * Subpart Ft--Food Additives Resulting From Contact With Containers or Equipment and .Food Additives Otherwise Affecting Food Resinous ani. Polymemc Coatincs The Food and Drug Administration Is amending the food additive regulations In 121.2514 Resinous and polymeric coatings (2J CFR 121.2514) to provide for the safe 'Use of vinyl chlorlde-vinylidene chloride^,3-epoxypropyl meth acrylate copolymers., as components of coatings intended to contact food; effec tive March 5.1976; objections by April 5. 1976. Notice was given by publication in the Federal Register of May 9, 1975 (40 FR 20337) that a petition (FAP 5B3Q49) had been filed by Union Carbide Corp., River. Rd., Bound Brook, NJ 08805. proposing SAPTER I--FOOD AND DRUG ADMINIS TRATION, DEPARTMENT OF HEALTty EDUCATION, AND WELFARE >-CHAPTER B--FOOD AND FOOD PRODUCT^ (Docket No. 75F-0289J / <c> To assure safe use of the adnitive. In addition to the other informatibn re quired by the act, the label and labeling ol the dried mixture-described Jn para graph (a) of this section shaUdSear: (1) The name of the addjttve. that s 9.514 h tr> prraiirl,. foptflifsafe use of vinyl chtoride-vinyliene chloride-2,3-epoxypropyl methacry late copolymers.,as components of coatintended to contact food. Th^CQmmissioner of Food and Drugs PART 121--FOOD ADDITIVES / (2) Adequate dlrectiop^Tor use provid issued a nbtie of proposed rule making ^jDpart C--Food Additives Permitted in Feed and Drinking Water of Animals or 'or the Treatment of FoodTVoducing Animals .S Formaldehyde ing that feed as eopedmed is not to con published In 'the Federal Recxstex of tain more than^ffpercent of the mixture. September 3, 1975"T4^ FR 40529) to re Any perspa'who will be adversely af strict the use of vinyl chjoridc polymers fected bx*4ne foregoing order may at any . in contact with food. The^aroposed reg time osi)r before April 5, 1976, file with ulations would prohibit the bse of vinyl the ^fearing Clerk, Food and Drug Ad chloride liomopolymers and copolymers t'he Food and Drug * dministration is ministration, Rm. 4-65, 5600 Fishers In food-contact articles except ' (1) i.\ ...lending the food additive regulations Lane, Rockville, MD 20852, written objec coatings, gaskets, cap liners, flexible tub :n Part 121 i21,CFR Part 121) to provide tion^ thereto. Objections shall show ing, and plasticized film or (2) If such ,-.-ir the safe ue of formaldehyde to Im- wherein the person filing will be ad use was specifically permitted in Part-121 ve the handling characteristics of ani versely affected by the order, specify with (21 CFRPart 121). mal fat in combination with certain oil- particularity the provisions of the order Since the petitioner is see ...;g use'as a .eed meals Intended lor use as a comunent of cattle feed: effective March 1976; objections'by April 5, 1976. Notice was given by publication In the "-oeral Register of December 17, 1975 .0 FR 5U484) that a food additive peti tion (FAP MF 3638) had been filed by Uta lipids (USA) Ltd.. PO Box 1187, .else, ID 83701, proposing that-Part 121, deemed objectionable, and state the coating, such use is appro.ablpAmdor grounds for theP^jections. If a hearing the proposed rules. This petitietfis there is requested, the objections shall state fore belng..ap}woved"CbndJti7nally. sub the issues for the hearing, shall be sup jectste'change if the final regulation on ported by grounds factuhfiy and legally /vinyl chloride polymers establishes con sufficient to justify the relief sought, and ditions for use dlflerent .rom those shall Include a detailed description and adopted in this regulatio.. Any such analysis of the factual information in ge will be subject to objection and tended to be presented in support of the requeSi-fijr hearing. Subpart C, be amended to provide for the safe use of the additive iii the feed i beef and nonlactating dairy cattle. The Commissioner of Vood and Drugs having evaluated the data in the food adi.tive petition and "other relevant ma terial, concludes''that the regulations should be amended to provide for the safe use of the additive as described be low. Therefore, under the Federal Food. Drug, and Cosmetic Act (sec. 409(c)(1), 72 Stat. 1786 (21 U.S.C. 348(c) <!)>. and objections in the event that a.nearing is held. Six copies of all documents shall be filed and should be Identified with the Hearing Clerk docket number found in brackets in the heading'of this order. Re ceived objections .nfay be seen in the above office during working hours, Mon day through Friday. EDective/iatc. This order shall become effective March 5.1976. (Sec. 406(C\(I). 73 Stat. 1786 (21 U.S.C. 34Svd (1)) ) r The CoraJtnssiougr. havin*,' evaluated data in the petitionShd* otLcr relevant material concludes that 3 121.2514 should be amended as set H-rJa below. Therefore, under the Feaeral l?ood. Drug, and Cosmetic Act $ec. 409fc> (1). 72 Stat. 1786 (21 U.S.C>>*erc) (In > and under authoriDt^dElcguted to the Commissionet^glTCFR 2120 3 121.2514 ib' (3) (xvi Ts amended by alphabetically Inserting In the list of sub-.tL.ices a new item, to read as follows: under authority delegated to the Com Dated: March, 1.1976. f 121.23 U K--kkmi* sr.,i polymeric missioner *21 CFR 2.120). Part 121. Sub- ,7.. rt C. is amended by adding the follow Note: Incorporation by reference provi sions approved by the Director oi the Federal roiling'. ing new section: Register. February 5, 107i., (b) * * $ 121.329 Formaldehyde. The food additive formaldehyde may be safely used in the manufacture of an imal feeds in accordance with the follow ing conditions: (a) The additive Is used, or Intended for use. to improve the handling charac William F. Randolph, Acting Associate Commissioner for Compliance. J FR Doc.76-C.731 Filed 3^4-70:8:45 am) 1 Copies may be obtained /rom: Ernest A. Epps. Jr.. Treasurer. Division ot Agricultural (31 (xvi * * Vluyl cii;orice-v::;7lldeue . cioride-C.jepoxyprop;; a.et^acryl&ie ..ytner* cs; tattling no; ,v.ore than 1C a elite- perce.c of `>1*1 pol.uicr units derived /rom 2.3epoxyprop/l methacrylate and not ao.'i teristics of animal fat in combination Chemistry. P.O. Box 1G390-A. Baton Rouge. than 0/35 - -ighi percent of uurcacted 2.3- with certain oilseed meals by producing LA 70303. opoxyprop, Methacrylate monomer based FEDERAL REGISTER. VOL 41, NO. 45--FRIDAY, MARCH S. 1976 see i-0164 9544 RULES AND. REGULATIONS on polymer solid* for usa only In coatings lor containers Intended for contact with food* under conditions rt, C, D, E, ?, a, or H described In Table 2 of paragraph (d) of this section. 72 Stat 1786 (21 U.S.C..348(c) (1) ).). and under authority delegated to the Com missioner. (21 CFR 2.120).. .Part 121 Is amended In $ 121.2524 by revising the in troductory text and paragraphs <c) and the Hearing Clerk. Food and Drug Ad ministration, Rm. 4-65, 5600 'Fisher* Lane,- Rockville. MD 20852. written ob-` lections thereto. Objections'shall.-show wherein the person filing win -be ad (d), and by adding new paragraph (1) Any person who will be adversely af to read, os follows: fected by the foregoing order may at any time on or before April 5, 1976, file 121.2524 Polyethylene iiittliolaie |KtIy- with the Hearing Clerk. Food and Drug inert. Administration. Rm. 4-65. 5600 Fishers . Polyethylene phthalate polymers iden Dane, Rockville. MD 20852. written ob tified In tills section may be safely used jections thereto. Objections shall show as, or components of plastics (films, wherein the person filing will be ad articles, or fabric) Intended for use in versely affected by* the order,, specify contact with food In accordance with the with particularity the provisions of the following prescribed conditions: order deemed objectionable, and state the grounds for the objections. If a hear <c) (1) .Polyethylene phthalate spun- ing Is requested, the objections shall state the Issues for the hearing, shall be supported by grounds factually and bonded nonwoven fabric consists of con tinuous filaments of ethylene terephthalate polymer and ethylene tereph- legally sufficient to justify the relief sought, and shall Include a detailed de scription and analysis of the factual In formation intended to be presented in support of the objections In the event thalate-isophthalate copolymer to which may have been added optional adjuvant substances required in their preparation and finishing. (2) The ethylene terephthalate-lso- that a hearing Is held. Six copies of all documents shall be filed and should be identified with the Hearing Clerk docket number found In brackets in the heading of this order. Received objections may be seen In the above office during working hours, Monday through Friday. -phthalate copolymer component of the fabric shall not exceed 25 percent by weight. The filaments may be blended with other fibers regulated for the specific use and the spunbonded fabric may be further bonded by-application of heat and/or pressure. versely affected by the order, specify with particularity the provisions of the order deemed objectionable, and state the grounds for the objections. If a hearing 1* requested, the objections shall state the issues for the hearing, shall be supported by grounds factuHW and legally sufficient to justify the relief sought, and aha)) Include a detailed description and analy sis of the factual information intended to be presented in support of the objec tions In the event that a hearing is held. Six copies of f>H documents shall be filcc and should be Identified with the Hearing Clerk docket number found in bracketin the heading of this order. Received objections may be seen in the above office during working hours. Monday through Friday. Effective date. This order shall beconu effective March 5.1976. Dated: February 27,1976. Sam D. Fine, Associate Commissioner Jor Compliance. (FR Doe.76-S333 Filed 3-4-7fl;8:46 otn| (Sec. 409(c)(1). 72 Stat. 1786 (21 U.S.C. 34S (3) The fabric shall be used only in <c)(l>)> accordance With paragraph (i) of this (Docket No. 767-0316) Dated: February 27. 1976. Sam D. Fine, Associate Commissioner /or Compliance. section. <d) The quantity of any optional sub stance employed in the production of polyethylene phthalate plastics does not exceed the amount reasonably required PART 121--FOOD ADDITIVES Subpart F---Food Additives Resulting Frorr* Contact With Containers.or Equipment and Food Additives Otherwise Affectm; (PR DOC.76-6332 Filed 3-4-76;8:45 am) to accomplish the Intended physical or Food technical effect or any limitation further Emulsifiers and/or Surface-Active (Docket No. 75F-03511 provided. Any substance employed In the production of polyethylene phthalate Agents PART 121--FOOD ADDITIVES plastics that Is the subject of a regulation The Commissioner of Food and Drug.- Subpart F- -Food Additives- Resulting From Contact With -Containers or Equipment and Food Additives Otherwise Affecting Food In Subpart F of this part conforms with any specification in such regulation. 0 (i) Polyethylene phthalate fabric, Is amending the food additive regula tions In S 121.2541 Emulsl/lers and/o? surface-active agents (21 CFR 121.2541 to provide-.for specification change it sodium monoaikylphenoxybenzenedi- Polyethylene Phthalate Polymers identified in paragraph (c) of this sec sulfonate and sodium dialkylphenoxy- The Commissioner of Food and Drugs tion and conforming with the specifica bonzenedisu'fonate mixtures for use Is amending 512142524 Polyethylene tions prescribed in paragraph (l)(l) of emulsifiers and/or surface active agen: phthalate polymers (21 CFR 121.2524) to this section, is used only as provided In in the manufacture of articles intend*, provide for the use of spunbonded poly paragraph (i) (2) of this section. to contact food; effective March 5,1976 ethylene phthalate nonwoven fabric, (1) Specifications. Chloroform-soluble objections by April 5, 1976.- - - effective March 5, 1976; objections by extractives shall not exceed 0.2 mihi-j Notice was given by publication in ill April 5, 1976. gram/inch9 of food-contact surface when Federal Register of September 17, 197* Notice was given by publication In the exposed to the following solvents at tem <40 FR (12912) that a petition (FA. Federal Register of November 25, 1974 peratures and times indicated: 5E3088) had been filed by Dow Chemir.-. (39 FR 41194). that a petition (FAP (1) Distilled water at 212* F for 2 Co.. 2030 Dow Center. MiiL: nd, M. 5B3039) had been filed by E. I. duPont hours. 48640. proposing that 121.2541 t de Nemours and Co., 1007 Market St., (11) n-Heptane at 150* F for 2 hours. amended to provide for specificatio. Wilmington. DE 19898. proposing that <1U) 50 percent ethyl alcohol at 12u' changes In sodium monoalkyiphenoxy the food additive regulations (21 CFR F for 24 hours. benzenedlsulfonate and sodium dialky, Part 121) be amended to provide for (2) Conditions o] use. The plastics are phenoxybenzenedisulfonate mixtures n. safe use of spunbonded polyester non Intended for: tended fer use as emulsifiers ar.d (or sin woven fabric consisting of ethylene ter- <1) Dry food contact. face-active agents in the mauufactur ephthalate polymer and ethylene ter- (il) Sulk food (excluding alcoholic of articles intended to contact food. Tb- ephihlate-lsophthalate copolymer as beverages) repeated use applications, in specification change would expand ih articles or components of articles In cluding filtration, at temperatures not compound to include alkyl groups in th tended to contact food. exceeding 212* F. range of Ct-Cw as compared to the cu< The Commissioner, having evaluated (lii> Filtration of bulk alcoholic bev rently regulated range of Cr-C,,. data in the petition and other relevant erages, not exceeding 50 percent alcohol The Commissioner,. having evaluate*, material, concludes that the food addi by volume, at temperatures not exceed data in the petition and other relevan tive regulations should be amended as set ing 120* F. material, concludes that S 121.25-i forth below. Any person who will be adversely af should be amended as set forth belov Therefore, under the Federal Food, fected by the foregoing order may at any Therefore, under the Federal Foo Drug, and Cosmetic Act (sec. 409(c) (1). time on or before April 5, 1976, file with Drug, and Cosmetic Act (sec. 409(c) (l' FEDERAL REClSTER. VOL 41. NO. 45--FRI0AY, MARCH 5, 1476 SCC 1-0165 RUi.ES AND REGULATIONS ' <1545 72 Stat. 1786 (21.UJ5.C. 348(cHl))3 aud essing of 'liquid bulk foods, effective of the membranes and the pre-use treat under authority delegated to the Com March 5,1976. : ment required by the .regulation would missioner (21 CFR 2.120)i 121.2341 Is The-Commissioner Issued, In the Fm- result In a reduction of any remaining amended In paragraph (c) to provide lor eral* Register of November 4. 1974 (39 vinyl chloride to the point that the Com revised specifications for the additive, to FR 38907), a proposal dealing with a missioner concludes that the use of the read as follows: & 121.2541 EniultiGcrt and/or surface active ... . * previously unknown migration problem of acrylonitrile monomer. (The migra tion problem may be common to many food-contact articles containing acrylonitrile copolymers.) The proposal ultra-filtration membranes would not reasonably be expected to result in vinyl chloride becoming a component of food. This petition Is therefore being approved conditionally, subject to change If the <c> also acknowledged the absence of toxi final regulation on vinyl chloride poly List of substances: * limitation* cological data to establish a definitive mers establishes conditions for use dif _* Sodium monoalkylphenoxybensenedlsulfonste and sodium dialkylpheaoxytMnzenedlsulfonate - Mno-effectM level for acrylonitrile mono mer. The proposal would define the prior sanctions for acrylonitrile copolymers under a new 1121.2010 (21 CFR 121.- 2010). and it would establish an Interim ferent from those adopted in this regula tion. Any such change will be subject to objection and request for hearing. Therefore, under the .Federal Food, Drug, and Cosmetic Act (secs. 201 (s), 402, mixtures containing not food additive regulation 1121.4010 (21 409, 701(a), 52 Stat. 1046-1047 as less than 70 percent of the monoalkylated prod uct where the alkyl, group ta. C'-C,.. .. a a * Any person who will be adversely af CFR 121.4010) for such copolymers to allow their continued use while .the ques tions raised are being resolved by fur ther study. Proposed 99 121.2010 and 121.4010 provide for a tolerance of 0.3 part per million (ppm) as the maximum amended. 1055, 72 Stat. 1784-1788 (21 UjS.C. 321 (s), 342, 348. 371(a))) and under authority delegated to the Com missioner (21 CFR 2.120). Part 121 is amended by adding 9 121.2634 to Subpart F, to read as follows: v fected by the foregoing order may at any time on or before April 5, 1976, file with the Hearing Cleric. Food and Drug Administration, Rm. 4-65, 5600 Fishers Lane, Rockville, MD 20852, written ob jections ' thereto. Objections shall show, wherein.the person filing will be ad versely affected by the order, specify with particularity the provisions of the order deemed objectionable, and state the grounds for the objections. If a hearing is requested, the objections shall state the Issues for the hearing, shall be sup ported by grounds factually and legally sufficient to justify the relief sought, and shall include a detailed description and analysis of the factual information in tended to be presented in support of the objections In the event that a hearing is held..Six copies of all documents shall oe filed and should be identified with the Hearing Clerk docket number found in brackets in the heading of this order. Re ceived objections may be seen In the amount of acrylonitrile monomer that [ 121.2634 UUrA-fUtr&tlou membranes e*r> migrate from the food-contact ar ticle; proposed. 1121.4010 requires sub j Ultra-filtration membranes Identified mission of certain chemical and toxico in paragraph (a) of this section may be logical data -to the Food and Drug safely used In the processing of food, Administration. ' Proposed 5 121.4010 is intended to apply to all food additive uses under the following prescribed condi tions: - of acrylonitrile copolymers. <a> The ultra-filtration membrane The Commissioner, having evaluated consists of papel* Impregnated with cured the data in a petition (FAF 4B2974) filed phenol-formaldeyhyde resin, which is by Dorr-Oliver. Inc., 77 Havemeyer used as a support and Is coated with a Lane. Stamford, CT 06904, notice of vinyl chloride-acrylonitrile copolymer. which was published in the Federal (b) Any substance employed in the `Register of January 21, 1974 (39 FR production of ultra-filtration membranes 2392). and other relevant material, con that is the subject of a regulation In this cludes that the food additive regula tions (21 CFR Part 121) should be Subpart F of Part 121 conforms with the specifications of such regulation. amended as set forth in 9 121.2634 below, (c) Ultra-filtration membranes are to provide for safe use of the ultra-flltra- used iu the physical separation of dis tlon membranes mentioned above. solved or colloidally suspended varying Furthermore, the Commissioner con molecular size components of liquids cludes that'the copolymers described In during the commercial processing of bulk 5 121.2634 will meet the 0.3 ppm acryloni quantities of food. trile monomer extractives limitation of . (d) Ultra-filtration membranes shall above office during working hours,-Mon day through Friday. Effective date. This order shall become effective March S. 1976. (Sec.' 400(e)(1), 72 Stat. 1786 (21 U.S.C. 348(e)(1))) pmposed { 121.4010 when used within the prescribed restrictions. Upon adoption of proposed 5 121.4010, 9 121.2634 will be amended to cross-reference the require ments of S 121.4010. The Commissioner Issued a notice of proposed rulemaking, published In the be maintained in a sanitary manner in accordance with good manufacturing practice so as to prevent potential micro bial adulteration of the food.. . (cj To assure sale use of the ultrafiltration membranes, the label or label ing shall include adequate directions for Dated: February 27,1976. Federal Register of September 3, 1975, a pre-use treatment, consisting of vm- Sam D. Fine, Associate Commissioner for Compliance. (FA Doc.76-6323 Piled 3-*-76;8:48 nm| to restrict the use of vinyl chloride poly mers in contact with food <40 FR 40529). The proposed regulations would prohibit the use of vinyl chloride homopolymers and copolymers in food-contact articles cuioning and washing with a minimum of 8 gallons of potable water pripr to their first use in contact with food. Any person who will be adversely af fected by the foregoing -order may At except (l) In coatings, gaskets, cap liners, any time on or before April S. 1976. file (Docket No. 7SP-0244] flexible tubing, and plasticized film or (2) with the Hearing Clerk. Food and Drug if such use was specifically permitted in Administration. Rm. 4-65. 5600 Fishers PART 121--FOOD ADDITIVES Part 121. The proposal would also amend Lane. Rockvllh. MD 20352. written ob Subpart F--Food Additives Resulting From Contact With Containers or Equipment and Food Additives Otherwise Affecting Food Ultra-Filtration Membranes a number of food additive regulations consistent with the proposed restrictions. The Commissioner has concluded that the use of vinyl chloride polymers pro vided by the'new 9 121.2634 Is similar-to that for mlcroporous polymeric filters in jections tiien.iL Objections shall How wherein the per.- on filing will be adverse ly affected by the order. Specify with par ticularity the provisions of the order deemed objectionable, and state the grounds for the objection. If a hearing The-Commissioner of Food and Drugs 5 121.2631 which was described in the is requested, the objections shall state is adding $ 121.2634 (21 CFR 121.2634) to preamble of the September 3d proposal the issues for the hearing, shall be sup provide for safe use of ultra-filtration as being permissible. Data were presented ported by grounds factually and legally membranes formed from vinyl chloride- in the petition that the level of residual sufficient to Justify the relief sought, and acrylonitrile .copolymers supported on vinyl chloride in the resin used to produce shall include a detailed description and sheets of paper Impregnated with cured the ultra-filtration membranes is less analysis of the factual information in phenol-formaldehyde resin In the proc- than t,6 ppm. The subsequent production tended to be presented in support of the FCDERAl RSClirfe. vot. 41. NO. AS--FRIDAY. MARCH 5. see -01 9546 RULES ANO REGULATIONS objections In the event that a hearing is held. Six copies of all documents shall be died and should be Identified with the Hearing Clerk docket number found in brackets in the heading of this order. Received objections may be seen In the above office during working hours, Mon day through Friday. Elective date. This order shall become elective March 5.1976. 47514, October 9, 1975) to revise {1301.- 28(d) of Title 21 of the Code of Federal Regulations regarding procedures'for the acquisition of controlled substances by ocean vessels. That notice Invited all in terested parties to submit their com ments or objections to the proposed revi sion on or before November 10, 1975. No such comments or objections have been received. made, by the Department of Housing and Urban. Development under section 235 of the National Housing Act (22 UB C 1715z); as amended. After consideration of all such relevant matter as was' pre sented by Interested rersorts regarding the rules proposed, the amendment of the regulations as proposed-is adopted by this document without change. ' Section 235 of the National Housing (Secs. 201(s) 402, 402, 701(a), 82 Stat. 10401017 u amended, 1056. 72 Stat. 1784-1708 (21 U.S.C. 321 (b) . 342.34S. 371(a))) Dated: February 27; 1976. Therefore, under the authority, vested in the Attorney General by sections 301 and 501(b) of the Comprehensive Drug Abuse Prevention aihd Control Act of 1970 (21 U.S.C. 821 and 871(b)). and del Act provides that, if a homeowner imd his mortgage satisfy certain specified re quirements, the Department of. Housing and Urban Development may make as sistance payments to the mortgagee. Sam D. Fine, . Associate Commissioner for Compliance. [FR Doc.76-0323 Filed 3-4-78:8:45 am] 1 SU8CHAPTER D--DRUGS FOR HUMAN USE . (Docket No. 75N-0326] PART 310--APPROVED NEW DRUGS THAT egated to the Administrator of the Drug Enforcement Administration. by 6 0.100 of Title 28 of the Code of Federal Regu' iatlons, the Administrator hereby orders that Title 21 of the Code of Federal Reg ulations be revised to read'as follows: 1301.28 Rcgiftlracion regarding ocean VCMcltf. * These payments are to be in an amount up to the lesser of (1) the wag of the monthly payment for principal, interest, taxes, insurance-and mortgage Insur ance premium over 20 percent of the mortgagor's income, or (2) the difference between the amount of the twnnthTy pay ment for principal, interest, and mort gage insurance premium and the amount which would be due for principal REQUIRE CONTINUATION OF LONG (d) If no medical officer Is employed interest if the mortgage bore interest at TERM STUDIES, RECORDS, AND RE by the owner or operator of a vessel, or the rate of one percent. PORTS in the event such medical officer is not The Congressional committee reports Revocation of listing of Levodopa accessible and the acquisition of con relating to section 235 Indicate that the The Food and Drug Administration is revoking the listing of levodopa In { 310.304(a) (21 CFR 310304(a)), which required continuation of long-term. studies, records, and reports after mar keting approval, effective April 5, 1976. trolled substances Is required, the master intent of Congress in enacting the sec of the vessel, who shall not be registered tion was to "authorize a new program under the Act, may purchase controlled . of interest subsidies to low and moder substances only with the approval of and ate Income families to purchase new or upon special order form (HSA-590, Au existing homes which they could not thorization to Purchase Controlled Sub otherwise afford." stances for Vessels, formerly HSM-590) Accordingly, the amendment to the The proposed revocation was published in the Federal Register of November 21. 1975 (40 FR 54252). Interested persons were invited to submit comments on the proposal within 60 days. No comments were received, and the revocation is adopted as proposed. provided by a medical officer of the United States Public Health Service. Upon Issuance, a copy of each Form HSA-590 will be immediately submitted by the USPHS facility where Issued to the Drug Enforcement Administration Regional Office covering the area in regulations provides that & taxpayer is not entitled to deduct Interest on an In debtedness to the extent of assistance payments that are made with respect to the indebtedness by the Department of Housing and Urban Development. No portion of the assistance payments would Therefore, under the Federal Food, which the facility is located. Blank or reduce other deductions, such as the de Drug, and Cosmetic Act (sees. 505(J>. presigned Form HSA-590 may not be duction for taxes. The amendment is ef 701(a). 52 Stat. 1055, 76 Stat. 782-783 furnished to ships or shipping com fective for taxable years beginning after (21 U.S.C. 355 (J). 371(a))) and under panies by USPHS. December 31,1974. . authority delegated to the Commissioner (21 CFR 2.120), Part 310 is amended in S 310.304 Drugs that are subjects of approved new-drvff applications and that This order shall become effective on March 5,1976. Rev. Rul. 75-271. 1975528 LR3. 8, states that payments to a mortgagee un der section 235 are not includible In the gross income of the mortgagor. require special studies, records, and re Peter B. Bensxncek. Adoption of amendment to the regu ports by revoking and reserving para Administrator, lation. On Wednesday. June 18,1975, no graph (a). Drug Enforcement Administration. tice of proper rd rulemaking with respect Effective date. This regulation shall be effective April 3, 2976. February 27, 1976. [FK Doc.76-0442 FUett 3-4-76:8:46 ami to the amendment of the Income Tax Regulations <26 CFR Part l) under sec tion 163 of the internal Revenue Code (Secs. 506(J), 701(a). 62 Stat. 1065, 70 Stat. of 1954, in order to clarify the income tax 782--703 (21 UA.C. 36fi(J), 371(a))} Title 26--Internal Revenue effects of assistance payments made by Dated: February 27,1976. Sam D. Fine, Associate Commissioner for Compliance. CHAPTER I--INTERNAL REVENUE SERV ICE, DEPARTMENT OF THE TREASURY SUBCHAPrER A--INCOME TAX (TJ5. 7408J the Department of Housing and Urban Development under section 235 of the National Housing Act (12 U-S.C. 17i5z), as amended, was published In the Fed eral Register < 40 FR 25679). After con (FR Doc.76-0324 Filed 3-4-T0;6:46 am] CHAPTER II--DRUG ENFORCEMENT AD MINISTRATION, DEPARTMENT OF JUSTICE pART l--INCOME TAX; TAXABLE YEARS BEGINNING AFTER DECEMBER 31, 1953 Interest Deductions of Mortgagors In Case of Certain Assistance Payments sideration of ail such relevant matter as was presented by interested persons, re garding the rules proposed, the amend ment of the regulations is hereby adopt ed as proposed. PART 13C1--REGISTRATION OF MANU FACTURERS, DISTRIBUTORS. ANO OISPENSERS OF CONTROLLED SUB STANCES Authorization To Purchase Controlled Substances for Vessels By a notice of proposed rule making appearing In the Federal Register for Wednesday. June 18. 1975 (40 FR 25679). an amendment to' the Income Tax Regulations (26 CFR Part 1) under section 163 of the Internal Revenue Code of 1954 (relating to the deduction for (See. 7805. Internal Revenue Code of 1064 (08A Stat. 917; 20 U.S.C. 7805)) C.Donald Alexander, Commissioner of Internal Revenue. Approved: March 1. 1976. Ckarles-M. Walker. On September 2S. 1975, the Acting Ad interest) was proposed to clarify the In Assistant Secretary of the ministrator Issued a proposal <40 FR come tax effects of assistance payments Treasury. FEDERAL REGISTER, VQl. 41, NO. 45--FRIQAY, MARCH 5. 1974 SCC 1-0167