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e FOOD DRUG COSMETIC LAW REPORTER Scope of Reporter . The Reporter is devoted primarily to the Federal Food, Drug, and Cos- metic Act and the Fair Packaging and Labeling Act, as administered by the Food and Drug Administration, the Poison Prevention Packaging Act, as administered by the Consumer Product Safety Commission, and the Compre- hensive Drug Abuse Prevention and Control Act, as administered by the Drug Enforcement Administration. These Acts are reported in full text, along with the texts of pertinent regulations, proposals, rulings, decisions, and other developments described at ff 5. A number of federal "related laws," such as the Virus, Serum, and Toxin Act of 1944, are reported in full text, with sum- maries of selected court decisions. Similarly, state laws of general application to food, drugs, and cosmetics are reproduced in full text, and summaries of selected rulings and decisions are also reported. In addition, related state laws pertaining to specific products or areas of the food, drug, and cosmetic industries are identified in separate lists of "Special Laws" with official cita- tions, for those who wish to consult the official texts. These "Special Laws" are laws governing standards, packaging, and labeling of specific products. All regulations issued by the Food and Drug Administration under the Food, Drug, and Cosmetic Act, the Fair Packaging and Labeling Act, and the Virus, Serum, and Toxin Act of 1944 are published in full text, as are regula- tions under the Poison Prevention Packaging Act, as amended by the Con- sumer Product Safety Commission. The full texts of the regulations issued by the Drug Enforcement Administration implementing the Comprehensive Drug Abuse Prevention and Control Act are reported. Regulations issued under some of the "related laws" in the Federal Laws division are not re- ported. No state regulations are reported. Federal and State court decisions are reported. Primarily, these decisions will be those cases that interpret or apply the provisions of the Federal Food, Drug, and Cosmetic Act and the basic food, drug, and cosmetic laws of the states. Cases that arise under the various state or federal "related laws" are reported on a selective basis. . HOW TO CITE THE REPORTER 111 Citations to FOOD DRUG CosasErre LAw REPORTS are accepted by courts and administrative agencies because they lead to authoritative data, some of which is available exclusively here. Just combine the letters "CCH" with the name of the Reporter and the paragraph number. For example, the food additive regulations may be cited "CCH FooD DRUG COSMETIC Lew REPOttrs, Q 55,300." A particular section of the regulations could be referred to by the specific paragraph of the Reporter where it is reproduced. COMMERCE, CLEARING, HO~U~SE.; I,N~C., PUBLIBHERiS of TOPICAL LAW RLpppTS 4025 W. PETERSON AVE., CHICAGO, ILLlNOiS 60646

C C 944 2-2-8t New Developments standard procedures. but data derived using OECD guidelines for these tests will be acceptable. It Is also recognized that special data requirements may dictate use of special tests. 4. Food Safety and Quality Service.- • Although the Food Safety and Quality Service does not usually require private industry to conduct the type of tests ineluded in the IRLG and OECD guidellnes, it fully supports and will encourage their use, by laboratory contractees of the Agency and by those submitting data to the Agency for review. 41,141 Dated: January 15,19g1. Susan King. Cttairmon, CongtuaerProdact Sopty Commission. Douglas M. Coala+ Administrator. Environmental Proteotion Agency. Jecs B Goyan, Commissioner, Food and Drug Administrvtion. Carol lYtt3cer Fot+em.n. Awistant 3earotary, Food and Consumer Service, Department of Agricultum. Etla Bln;ham, Assistartt Becrotary JorLabor, Oacupational Safety cnd Health Admiaistratiot. 140,838 SUMMARY OF CONCLUSIONS ON SAFETY OF GRAS AND PRIOR SANCTIONED SUBSTANCES Federation of American Societies for Experimental Biology Report, dated Apri130, 1980; released December 1980. Reproduced below is a summary of the final report to the Food and Drug Administration by the Federation of American Societies for Experimental Biology's Select Committee on GRAS Substances concerning the Committee's evaluation of pre-1958 food ingredients considered either prior sanctioned or generally recognized assafe.Included is a table (Exhibit 2) of the substances evaluated by the Committee with codes to identify the Committee's conclusions as to each substance. The five codes and their inter- pretations are explained in Exhibit 3. Exhibit 4' is a list of requests that the Committee received from the FDA for the evaluation of additional substances. The report is discussed at 140,792. See ¶ 56,015 FINAL REPORT-FDA 223-75-2004, "Evalu- ation of GRAS Mono- graphs (Scientific Litera- ture Reviews)" For Period: March 28, 1972 through' March 30, 1980. In accordance with the provisions of Contract No. FDA 223-75-2004, dated May 22, 1975, the contractor has evaluated and submitted reports to FDA on the health aspects of the GRAS and prior- sanctioned substances covered in 83 monographs provided by FDA, and on additional related substances that were requested by FDA. In a previous Contract, No. FDA 72-85, the health aspects of the substances covered in 35 other monographs were evaluated and reports submitted to FDA. A total of 118 monographs was received and reports were submitted on the evaluation of 415 substances under these two contracts. Of these~ substances, 335 were evaluated under the present Contract No. FDA 223-75-2004. Safety evaluations were performed by a review committee, identified as the Select Committee on GRAS Substances (SCOGS), that was selected and Food Drug Cosmetic Law Reports appointed by the contractor. Initial appointments . of the I I-member committee were made under the previous Contract (FDA 72-85). Membership of the Select Committee, and periods served, are given in Exhibit I. [Exhibit I omitted.-CCH.] One member resigned and a replacement was ap- pointed during the current contract period. Thirty- seven meetings of the Select Committee were held during the period of the current contract, May 22, 1975 through March 30, 1980. The enclosed Summary Table (Exhibit 2) lists substances evaluated, dates that the corresponding monographs were received, dates that reports (numbered as given in column 1) were sent to FDA, and the National Technical Information Service (NTIS) numbers assigned to the reports that are available at this date. All reports sent to FDA after May 22, 1975, were completed under contract No. FDA 223-75-2004. As indicated in the Summary Table (Exhibit 2), announcement of opportunity for public hearing was made in the Federal Register for the tentative reports on all monographs evaluated under Con- tract No. FDA 223-75-2004. The Summary Table lists the dates that hearings were held, if requests 140,838

41,142 New Developments were received. Also indicated are the reports for which no requests for hearing were received, those for which requests were received but were subse- quently withdrawn, and those for which only writ- ten statements were submitted in lieu of oral presentation. The conclusions reached with respect to the safe- ty of the substances evaluated are indicated in the Summary Table (column 3) by the numbers 1-5. The corresponding conclusion statements and the interpretation of these statements as agreed upon by the contractor and the technical representative of the contracting officer, are given in the attached statement entitled "Conclusion Statements and In- terpretations of Statements" (Exhibit 3). Exhibit 4 lists requests that were received from FDA to evaluate the safety of additional substances not identified in the monographs, or to evaluate data that had become available after final reports had been submitted to FDA. The latter re- quests were generally answered by letter after con- sideration by the Select Committee. However, in the case of the request for evaluation of new infor- mation on glutamates, SCOGS-37a, and protein hydrolyzates, SCOGS-37b, the data were so exten- sive that news supplemental reports were prepared. In the case of iron and iron salts, SCOGS-35, the report prepared under the previous Contract (No. FDA 72-85) was revised, a public hearing held, and a revised report submitted to FDA. . As stated in the Introduction section of the reports submitted to FDA, the scientific literature reviews (monographs) furnished by FDA were sup- plemented plemented by literature searches of over 30 scien- tific and statistical reference sources and compen- dia that :are generally available; new, relevant books and reviews and literature citations contain- ed in them; current literature citations obtained 944 2-2-8t through retrieval systems of the National Library of Medicine; searches for relevant data in the files of FDA; and by the combined knowledge and ex- perience of the Select Committee and the contrac- tor's staff. Relevant information also was obtain- ed from industrial companies and trade' associa- tions. The following reports of special supplemen- tal literature reviews were prepared and submitted to FDA: Review of the 1972-1976 Literature on the Health Aspects of Copper Salts as Food Ingre- dients. (PB-275 749) Review of the Recent Literature on the Health Aspects of Cases as Food Ingredients. (PB-275 70) Review of Recent Literature on the Health Aspects of Lecithin as a Food Ingredient. (PB-275 751) Review of the Recent Literature of the Health Aspects of Riboflavin and Riboflavin 3'-Phosphate as Food Ingredients. (PB-275 753) Review of the Recent Literature on the Health Aspects of Niacin and Niacinamide as Food Ingredients. (PB-275 752) Review of the Recent Literature on the Health Aspects of Vitamin Bu as a Food Ingredient. (PB-275 755) The report, "Evaluation of the Health Aspects of GRAS Food Ingredients: Lessons Learned and Questions Unanswered", prepared by the Select Committee, was published in the October 1977 issue of Federation Proceedings. As requested, two hundred reprints were sent to the Contracting Officer's Technical Representative and the GRAS Review Branch. 140,838 ©1981, Commerce Clearing House, Inc. ( ( ( c

-~ Date t]pportunity Date A ~ O SCOGS Report No. SCOGS Substances Evaluated Conclusion Mannerarh Received for Hearint Announced* Hearing Date$ Report Sent to FDA NTIS No. L A 00 tJf 41 00 25 Cellulose (continued) Sodium carboRymethyl cellulose 1 Hydroaypropylmelhyl cellulose 2 Ethyl cellulose (in packaging) 1 „ „ Cellulose acetate (in packaging) 1 26 Carbonates 01/03/73 08/29/75 N/R 11/21/7S P8-254 535 Calcium carbonate 1 Potassium bicarbonate 1 Potassium carbonate 1 Sodium bicarbonate 1 Sodium carbonate 1 Z Sodium sesquicarbonate I ~ X 27 Propylene glycol 01/11/73 t 1 02/19/74 PB-26S 504 Propylens glycol Propylene glycol monostearate 1 ~ 28 Glycyrrhlaa 01/11/73 12/19/74 N/R 04/0e/75 PB-2S4 $29 0 Glycyrrhitln 2 ~ ~ Glycyrrhitin, ammonlated 2 ~ Llcorke 2 y ~ A o .29 i Caprylic acid 1 01/29/73 12/19/74 N/R 04/0tl/7S PB-2S4 330 ~ D0 Glycerldes 02/0S/73 0R/29/7S N/R 12/19/75 PO-2S4 S36 Glycerin 1 ~ i{ Munoglycerldes of edR.to fats or oils A or edible fat-formin3 fatty acids 1 Q Diglycerides of adibls fats or oils ~ or edible fat-forming fatty acids 1 111~~~111 Ac e toolsini I ,x Acetostearins .1 1 s Dlacetyl tartarie acid asters of ~ P. mono3lycerldes 1 N ~" !Key: N/R  No requests received a, p t  keports completed before Initiation of•hearinj proeedures In 1974 ozzsss98 I

New Developments 42,316 1019 7-6-82 hydroxide, which Is published elsewhere in this issue of the Federal Register. The requested deletion from the proposed regulation of CGMP maximum levels of use for adipic acid is therefore denied. In 1964 an FDA official issued an opinion letter that recognized the GRAS status of sodium adipate as a buffer and neutralizing agent. However, the agency announced in the January 30,1979 proposal (44 FR 5905) that It does not consider itself bound by the 1964 opinion letter because it does not possess certain information that in accordance with g 170.35, Is required in order to affirm the GRAS status of sodium adtpate. In particular, the agency is unaware of the manufacturing methods and food-grade specifications for sodium adipate, the food categories in which it is used, and the usual•and maximum use levels in each food category. Because the lack of this information prevents, theAefinition of conditions of safe use, FDA requested the submission of this information as comments on the proposal. No comments on sodium adipate were received in response to the proposal. Therefore, sodium adipate is not being affirmed as GRAS by FDA: Future FDA approval of sodium adipate may be sought through the GRAS or food additive petition procedures outlined in 1170.35 or # 171.1(21 CFR 171.1) for any new use of this substance. Alternatively, an independent GRAS determination may be made in accordance with g 170.30 (21 CFR 170.30) and 1164.1 for uses of sodium adipate consistent with available safety data on this substance. The agency has determined under 21 CFR 25.24(d)(8) (proposed December 11, 1979, M FR 717d2) that thi~ action ia of a type that does not individually or cumulatively have a significant impact on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement • ts requited.- . ln accordance with Executive Order 12291. FDA has carefully analyzed the economic effects of this rule, and the agency has determined that the rule is not a major rule as defined by that. order. List of Subjects 21 CFRPIurt172 Food additives; Food preservatives; Spices and flavorings. 21 CFR PattY82 Generally recognized as safe (GRAS) food ingredients; Spices and flavor[ngs. 21CFRPart18! Direct food ingxedients; Food • ingredients; Generally recognized as safe (GRAS) food ingredients. Therefore, under the Federal Food, . Drug, and Cosmetic Act (secs. 201(s), 409, 701(a), 52 Stat 1055, 7Z Stat.1784- 1788 as amended (21 U.S.C. 321(s~ 348, 371(a))) and under authority delegated to the Commissioner of Food and Drugs (Zi CFR 5.10), Parts 172,.182, and i84 are amended as follows: . * * * * * Effective date. This regulation shall be -effective July 2e,1982. _. Note,4[ncorporation by reference approved by the Director of the Office of the Federal Register on May 27,198Z, and is on file at the Office of the Federal Register. (Sees. 201(s). 409, 7o1(a). 52 Stat 1055, 7z Stat 1764-178e as amended (21 U.S.C. 921(s), 348, 371(e))) . Dated: June 7.19e2. William F. Randolpb, Acting Associate Commissioner for RegulatoryAffairs. . 142,044 PROPYLENE GLYCOL'S GRAS STATUS AFFIRMED C ( c Food and Drug Administration Order, published at 47 F.R. 27810, June 25. 1982. . Propylene glycol has been affirmed by the Food and Drug Administration as a generally recognized as safe direct food ingredient. However, because pro- pylene glycol monostearate is already the subject of a food additive regulation, the agency has withdrawn the proposal to affirm the GRAS status of this substance to avoid redundancy and confusion. In response to comments, the 142,044 ©1982, Commerce Clearing House, Inc.

1019 7-6-82 New Developments 42,317 maximum level of propylene glycol in seasonings and flavorings was increased to 97 percent concentrations in which the finished food product contains 2 per- cent and was increased in baked goods, in fats and oils, and in dairy products in response to current usage information. A use level of 5 percent of propylene glycol in nuts and nut products (including coconuts) was added to the other GRAS listing for the substance. See 157,917.66 C C c (Dooket No. 77N-o012] susawuRr. T'he Food and Drug tldminstration (FDA) is affirming that propylene glycol is generally recognized as iafe (GRAS) ae a direct human food ingredient. However, FDA is withdrawing the proposed GRAS . affiraiatlon of propylene glycol monostearate as a direct food ingredient because this substance Is already subject to a food additive regulation. The safety of propylene glycol and propylene glycol monostearate has been- evaluated under the agency's comprehensive review of substances considered to be GRAS or subject to a prior sanction. EFFECTIVE oATE July 28,1982. FOR FURTHER 1NFORMATION CONT/ICT: John W. Gordon, Bureau of Foods (FFF- 335), Food and Drug Adminiatration, 200 .C St SW., Washington, D.C. 2020s, 202- 428-A4ti3. suPVLENtENTARY RtFORruuttow In the Federal Register of June 17,1977 (42 FR 30885), FDA published a proposal to affirm that propylene glycol and propylene glycol monostearate are GRAS for use as direct human food ingredients, and that propylene glycol Is also GRAS as an indirect human food ingredient. The proposal was published in accordance with the announced FDA review of the safety of GRAS and prior• sanationed food ingredients. In accordance with I 170.35 (21 CFR 170.35), copies of the scientific literature review on propylene glycol and derivatives, reports of the teratogenic and mutagenic screening tests for propylene glycol, and the report of the Select Committee on GRAS Substances (the Select Committee) on propylene glycol and propylene glycol ~ monostearate are available for public review in the Dockets Management Branch (HFA-05), Food and Drug Administration, Rm. 4-02, ti600 Fishers Lane, Rockville, MD 20857. Copies of Food Drug Cosmetic Law Reports these documents have also been made available for public purchase from the National Technical Information Service {IVT7S) as indicated in the propoeaL In addition, a mutagenic study on propylene glycol, which was not listed in the pnoposal, is available for public review in the Dockets.Management Branch (address above), and may be purchased from NTIS (order No. PB 257- WAS, price code A03, price $4.50). This study did not indicate that the public health would be adversely affected by the use of propylene glycol as a GRAS food ingredient. In addition to proposing to affirm the GRAS status of propylene glycol and propylene glycol monostearate. FDA gave public notice that it was unaware of any prior-sanctioned food ingredient use for these substances, other than for the proposed conditions of use. Persons asserting additional or extended uses, in accordance with approvals granted by the U.S. Department of Agriculture or FDA before September 8,1958, were given notice to submit proof of those sanctions, so that the safety of the prior- sanctioned uses could be determined. That notice was also an opportunity to have prior-sanctioned uses of propylene glycol and propylene glycol monostearate recognized by issuance of an appropriate regulation under Part 181-Pc3or-Sanctioned Food Ingredients (21 CFR Part 181) or affirmed as GRAS under Part 184 or 186 (21 CFR Parts 184, 188), as apptoprlate• FDA also gave notice that failure to submit proof of an applicable prior sanction in response to the proposal would constitute a waiver of the right to assert that sanction at any future time. No reports of prior-sanctioned uses for propylene glycol or propylene glycol monostearate were submitted in response to the proposal. Therefore, in accordance with that proposal, any right to assert a prior sanction for a use of propylene glycol under conditions . 142,044

42,318 New Developments different from those set forth in this regulation has been waived. Fifteen comments were received itt response to the agency's proposal and supporting information on propylene . glycol and propylene glycol monostearate. A summary of the comments and the agency'sresponaes followsr 1.'l~vo.comments asked whether a contradiction exists .between the GRAS affirmation for propylene glycol monostearate and the existi:ig : regulation, # 172.858 (21 CFR 172.858),.on propylene glycol mono- and diesteri of fats and fatty acids. Several comments were also received concerning methods of manufacture and usage of propylena . glycol monostearate. Because of the existing food additive regulation (21 CFR 172.858) for . propylene glycol monostearate, the agency agrees that GRAS affirmation for this ingredient would create a redundancy and could also cause confusion. Consequently, the agency is withdrawing the proposal to affirm propylene glycol monostearate as . GRAS. The current food additive . regulation governs the uses of the substance reported during the survey of food manufacturers (conducted by the National Academy of Sdences/National Research Council (NAS/NRC)) and during the comment period on the proposal. 2. Three comments asserted that the proposed maximum level of 16 percent for propylene glycol in seasonings and flavorings was impractiaal and requested that a higher use level be permitted in this food category. As a comment pointed out, even when the concentration of propylene glycol in a flavoring is 97 percent, the concentration of the substance consumed In the finished food product is less then 2.0 percent. The agency agrees,with the comments and concludes that the use of propylene glycol in flavorings only producea a small amount of the substance in the finished food as served. Processor information available to the agency confirms the comment described above. Consequently, the regulation has been modified to include the current good manufacturing practice (CGMP) 142,044 1019 7-"2 maximum level of use of up to 97 percent propylene glycolin seasonings and flavorings. (The regulation has als0 been modified to include a CGMP maximum level of use of 2.0 percent for all other food categories: This change is discussed below.) 5. Three comments requested that additional food categories and levels of use be provided for propylene glyeol. Two requests were for use of propylene glycol at a use level'of:5 percent in coconnt, and one request was for the use of the substance at a level of 4 percent • in nuts and nut products as defined by . I 170.3(n)(82) (21 CFR 170.3(n)(32)). The ageqcy has determined that there are adequate safety data to support the levels of usage for these additional food categories, and that these requests are appropriate. Therefore, the final rule has been modified to Include the use of propylene glycol at a CGMP maximum level of use of 5 percent in nuts and nut products, inrduding coconut. ., - 4.1wo comments stated that • propylene glycol is used as a component of adhesives under g-175.105 (21 CFR 175.105) and requested that the proposed regulation be modified to include the use of propylene glycol in adhesives under 1186.1898 (21 CFR 188.1888). . . Because the use of GRAS substances, including propylene glycol, in Adhesives is provided for In $175.105, the listing of propylene glycol in Part 188 for use in adhesives is unnecessary. Consistent with its traditional practice, FDA proposed originally to establish separate regulations for propylene g!ycol in Parts 184 and 186 to govern its direct and indirect GRAS uses, respectively. Under;184.1(a) (21 CFR 184.1(a)), however, ingredients affirmed as GRAS for direct food use in Part 184 are considered to be GRAS for indirect uses without a separate listing in Part 188. Based on I 184.1(a), FDA has rgconsidered its traditional practice and has concluded that the duplicative listing in Part 188 is unnecessary, as a generhl rule, and may cause confusion. Thus, unless safety considerations make it necessary to impose specific purity specifications or other restrictions on the indirect use of a GRAS substance, FDA will no longer list in Part 186 ©1982, Commerce Clearing House, Inc. ( C ( C

C t ( C 1019 7-6-82 New Developments 42,319 substances that are affirmed as GRAS for direct use in Part 184. In keeping with this change in policy. FDA will not promulgate f 188.1888 a4 originally proposed. The indirect uses of propylene glycol proposed for inclusion in J 188.1886 are authorized under I 184.1888 (Zi CFR 184.1888) and i 184.1(a). In the case of propylene glycol, FDA finds that the general requirements that . Indirect GRAS ingredients be of a purity suitable for their intended use in accordance with ;17o.30(h)(1) (21 CFR 170.3o(hxi)) and used in accordance with current good manufacturing • practice are sufficient to ensure the safe use of this ingredient. Therefore, no specific purity specifications are necessary for indirect use. Although the policies discussed in the two preceding paragraphs are not inconsistent with the agency's current regulations, elsewhere in this Issue of the Federal Register the agency (s publishing a proposal to amend its procedural regulations in Parts 184 and 186 to reflect clearly these policies. Additional Information from the NAS/ NRC industry survey regarding the current good manufacturing practice maximum levels of use of propylene glycol has been made available to the agency since the publicatioq of thi June 17,1977 proposal-to affirm propylene - glycol as GRAS. This new information indicates that the maximum-CGNIP reported level of use of propylene glycol has been increased to 1.5 percent in baked goods and in fats and oils and 2.5 percent in frozen dairy products. The proposed CGMP maximum level of use of propylene glycol in baked goods, fats and oils, and irozen dairy products in the proposed regulation was 1.0, 0.08, and 0.8 percent, respectively. Because FDA has stated that the GRASS affirmations will reflect the conditions of use that currently exist or that are reasonably foreseeable (39 FR 34194, 34195; September 23,1974), the final regulation has been revised to reflect this new usage information. The final regulation as revised states that under current good manufacturing practice the maximum levels of use of propylene glycol In frozen dairy products is 2.5 Food Drug Cosmetic Law Reports percent and in "all other food categories" is 2.0 percent (see the agency's response to comment 2 above concerning flavoRings). The baked goods and fats and'oiL food categories have been eliminated because they are now under "all other food categories: " Because the use of propylene glycol as a color was reported by the NAS/H1RC industry survey, the proposed regulation listed the technical functional effect of the ingredient as a color and coloring adjunct, as defined in;170.9(o)(4) (21 CFR 170.3(o)(4)). The agency has determined, however, that the listing of GRAS ingredients for direct nse in food as coloranta is inappropiiate because the evaluation of ingredients for-direct color use is properly the subject of color additive regulations. Accordingly, FDA has removed the lieting of propylene glycol for use as a color and coloring adjunct from the final regulation. The use of propylene glycol as a color diluent Is permitted under the existing color additive regulation (21 CFR 73.1(a)). which provides for the use of GRAS ingredients as diluents In color additive mixtures for food use exempt from certification. However, the GRAS affirmation proposal did not list a. technical functional effect that would cover this use. To accommodate this use. the final rule has been modified to include use of the ingredient in food as a processing aid as defined by i 170.3(o)(?d). The agency has determined under 21 CFR 25.24(d)(6) (proposed December 11. 1979; 44 FR 71742) that this action is of a type that does not individually or cumulatively have a significant impact on the human environment Therefore, neither an environmental assessment nor an environmental impact statement is required. In accordance K+Ith Executive Order 12291, FDA has carefully analyzed the economic effects of this rule, and the agency has determined that the rule is not a major rule as defined by the Order. List of Subjects 21 CFR Pqrt 182 Generally recognized as safe (GRAS) food ingredients; Spices and flavorings. 142,044

42,320 New Developments 21 CFR Part 184 Direct food ingredients; Food sa~fe (GRAS) food in~ediend ~ Therefore,-under the Federal Food. - Dnlg, and Cosmetic Act (sece. 201(s), 409, 701(a), 52 Stat. 1055, 72 Stat.1784- 1788 as amended (21 U.S.C. 321(s), 348, 371(a})) and under authority delegated to the Commissioner of Food and Drugs (21 CFR 5.10), Parts 182 and 184 are amended as follows: ***** 1019 7b82 Effective date: This regulation is effective on )uly 28,1982. Nohrinoorporatton by reference approved by the Director of the Office of the FedeW Register on March Si,,,1982, and is on file at the Office of the Federal Register. (sec.: zol(s}, 4oa; mi(a), sz Stat. zosa, 7z Stat. 178f-i78s as amended (21,U.S.C. 821(s), 848, ~(a)n Datad: June 7,1082. . - William F. Randoipb, AcchwAssoctara coaimtsstoner for PaSnlatoryA/fOim 142,045 GRAS STATUS OF ACETIC ACID, SODIUM ACETATE, SODIUM DIACETATE AFFIRMED Food and Drug Administration Order, published at 47 F.R. 27813, June 25, 1982. The generally recognized as safe status of acetic acid,.sodium acetate, and sodium diacetate for use in human food has been affirmed by the Food and Drug Administration. The agency did not affirm the GRAS status of am- monium acetate due to a lack of information regarding its use, manufacturing procedure, or specifications: Maximum use levels for acetic acid were increased in cheese and dairy product analogs and were added for chewing gum and boiler water, as were maximum use levels for sodium ,acetate in hard candy. Acetic acid content must be declared in labeling and may not be substituted for vinegar in pickled food. The FDA's responses to comments on the proposal are included in the preamble to the final order, reproduced below. [Docket No. 7$N-03001 SlAStytARY: The Food and Drug Administration (FDA) is af8rming that acetic add, sodium acetate, and sodium diacetate are generally recognized as safe (GRAS) as direct human food ingredients. It is also not affirming the GRAS status of ammonium acetate because there is no usage fnformation concerning this substance. The safety of these Ingredients has been evaluated under the comprehensive safety review being conducted by the agency. EFFECTIVE DATE July 28,1982. FOR FURTNER INFORMATION CONTACT: Corbin L Miles, Bureau of Foods (IffF- 335), Food and Drug Administration, 200 C St. SW., Washington. DC 20204, 202- 472-4750. SUPPLEMENTARY INFORMATIOIC In the Federal Register of April 3,1979 (44 FR 19430), FDA published a proposal to affirm that acetic acid. sodium acetate, and sodium diacetate are GRAS for use as direct human food ingredients. j 42,045 See ¶ 57,911.5; 57,918.21; 57,918.54 Additionally. FDA proposed that - ammonium acetate be removed from GRAS status because there is no Information that it is currently being used in food. The proposal was published in accordance with the annbunced FDA review of the safety of GRAS and prior-sanctioned food Ingredients. In acxorda'tice with j 170.35 (21 CFR 170.35), copies of the scientific literature review of acetic acid, sodium acetate, sodium diacetate: and ammonium acetate, reports of the mutagenic and teratogenic tests for each Ingredient, and the report of the Select Committee on GRAS Substances (the Select Committee) are available for public review in the Dockets Management Branch (IFA-305), Food and Drug gdministration. Rm. 4-82, 5800 Fishers Lane, Rockville. MD 20857. Copies of these documents also are available for public purchase from the National Technical Information Service as announced in the proposal. ©1982, Commerce Clearing House, Inc. C ( C ~

1].20 6-4-84 Carponents of coatings 56,909 ( C c c < appendix X 1.3 (ASTM method D1243- 79, "Standard Test Method for Dilute Solution Viscosity of Vinyl Chloride Polymers." which is incorporated by reference; see paragraph (b) of this section for availability of the incorporation by reference) with the reduced viscosity determined for three concentration levels not greater than o.5 gram per deciliter and extrapolated to zdro concentration for intrinsic viscosity. , The following formula is used for determining re- duced viscosity: Reduced viscosity in terms of deciliters per gram_ r-ro roxe Where: t=Solution efflux time. to=Soivent efflux time. c-Concentration of solution in terms of grams per deciliter. [As amended, 47 F.R. 11839, Mar. 19, 1982; 49 F.R. 10087, Mar. 19, 1984.] [1f56,895] $175.300 Resinous and polymeric coat- ings. Resinous and polymeric coatings may be safely used as the food-contact surface of articles intended for use in producing, manufacturing, packing, processing, preparing, treating, pack- aging, transporting, or holding food, in accordance with the following pre- scribed conditions: (a) The coating is applied as a con- tinuous film or enamel over a metal substrate, or the coating is intended for repeated food-contact use and is applied to any suitable substrate as a continuous film or enamel that serves as a functional barrier between the food and the substrate. The coating is characterized by one or more of the following descriptions: (1) Coatings cured by oxidation. a (2) Coatings cured by polymeriza- tion, condensation. and/or cross-link- ing without oxidation. _ (3) Coating5 prepared from prepoly- merized substances. . (b) The coatings are. formulated from optional substances that may in- clude: Food Drug Cosmetic Law Reports (1) Substances generally recognized as safe in food. (2) Substances the use of which is permitted by regulations in this part or which are permitted by prior sanc- tion or approval and employed under the specific conditions, if any, of the prior sanction or approval. (3) Any substance employed in the production of resinous and polymeric coatings that is the subject of a regu- lation in Subchapter B of this chapter and conforms with any specification in such regulation. Substances named in this paragraph (b)(3) and further identified as required: (i) Drying oils, including the trigly- cerides or fatty acids derived there- from: Beechnut. Candlenut. Castor (including dehydrated). Chinawood (tung). Coconut. Corn. Cottonseed. Fish (refined). Hempseed. Linseed. Oiticica. Perilla. Poppyseed. Pumpkinseed. Safflower. Sesame. Soybean. Sunflower. Tall oil. Walnut. The oils may be raw, heat-bodied, or blown. They may be refined by filtra- tion, degumming, acid or alkali wash- ing, bleaching, distillation, partial de- hydration, partial polymerization, or solvent extraction, or modified by combination with maleic anhydride. (ii) Reconstituted oils from triglycer- ides or fatty acids derived from the oils listed in paragraph (b)(3)(i) of this section to form esters with: Butylene glycol. Ethylene glycol. Pentaerythritol. Polyethylene glycol. Polypropylene glycol. Propylene glycol. Sorbitol. Trimethylol ethane. Trimethylol propane. (iii) Synthetic drying oils, as the basic polymer: Butadiene and methylstyrene copolymer. 21 CE'R 175.300 V56,895