Document EZeBozd5mpLkDL5dymkb072L

JAN 2 0 1969 January 16, 1969 William E, McCormick, Chairman The B. F. Goodrich Co* 500 S Main Street Akron, Ohio 44318 Dear Bill: In response to your letter of January 14, I would be pleased to serve as Chairman of the ad hocconmittee on good manu facturing practices for food manufacturing plants, I will telephone you. Dr. Knapp and Mr. Philpitt during the week of January 20 to discuss this matter. Very truly yours, FFDnaa cc: M. M. Hoover Dr. W. A. Knapp ^ V. H, Knoop R. H. Philpitt Frank P. DiPrima Attorney ASI 00002321 f JAN 1 6 1965 i* tic Chcnlcals The B.F.Goodrich Co 500 8. Main St. Akron, Ohio 44318 1/14/69 Hr. Frank F. DiFriaa March 6 Co., Inc. Xahwwy, Maw Jersey 07065 Dear Frankt X an euro you arc familiar with tka revised IDA order that appeared Oacaahar 20 Fadaral Kegister on goad asnwfaeturlng prastlaaa for featuring plants. Ton recall that MCA objected to certain positions proposed regulation when it first appeared but these objections have not appar ently been accepted, inessuck as the Pecanbar 10 regulation still contains than. Considerable revision has been ends, and in recent discussions between Morgan Hoover and nysalf, we have hath arrived at the feeling that a nnall mb* rrn--lttec should study in detail this proposed regulation and establish a posi tion on it for MCA, Xt night well be that car position will be the sane as it originally was and, if so, we will norely reiterate it; however, there night be X would appreciate, therefore, if you would serve as the Chairmen of this group, and by copy ef this latter 1 an aching Bill Knapp end Dick Fhllpltt to also serve with you. All of you are within the sane geographical area and, hopefully, this will faellltate any conversations or personal contacts that yew night feci we wish to Very truly yours ee! V.A. Knapp y K.H. Fhllpltt V.H. Knoop M.M. Hoover V.S. MeGsmlek Chalman ASI 00002322 F Vm4, hvug, aed OWMMtlc Chemicals JAN 1 S 1969 Tha 8.F.Goodrich Co. 500 S. Main St. Akron, Ohio 44318 1/14/49 Mr. Frank P. DlFriaa March 4 Co., Inc. Rahway, Maw Jaraay 07065 Daar Frank: .* >> ** * 1 an aura you arc faailiar with tha revised FDA order that appaarad December 20 Federal Uglitar on good Manufacturing practices for featuring plants. Toe recall that MCA objected ta certain positions ef'Fhe proposed regulation whan it first appeared hut these objections hare not appar ently been accepted, loawuch as the Oeconbar 20 regulation still contains than. Considerable revision has been node, and in recent discussions between Morgan Hoover and ayself, we have both arrived at the feeling that a snail subaonelttee should study in detail this proposed regulation and establish a posi tion on it for MCA. It eight well he that oer position will be the sene es it originally was and, if so, ws will eerely reiterate it; however, there eight be other eoneenta that we should eeks. X would appreciate, therefore, if you would serve ea the Chairwa of this group, and by oopy of this letter I an aaklng till Knapp and Disk Fhilpitt to also aerve with you. All of you are within the sees geographical area and, hopefully, this will facilitate any converaetlens cr personal contacts that yoe eight feel eld-Fsbrwary to flic *atever eoneenta we wish to Very truly yours, J V.A. Knapp t.H. Fhilpitt V.H. tnoop M.M. Hoovar V.I. McCormick Cheirean ASI 00002322 PROPOSED RULE MAKING ' 399 Ci rkb i.:-Ij lii' rDD- pint, and fluid ounce subdivisions ill thereof. pbii.yh'^:".i', n.,M,:iJl nl-Li/ii'HX" Food end Drug Administration [ 21 CPR Fart 1 ] PICKLE PRODUCTS Standardization of Quemtily of Con tents Declaration in Terms of Volume Any interested person may. within SO days from the date of publication of this notice in the Fhoes.'l Register, file with the Hearing Clerit, Department of Heath, Education, and Welfare, Pooin 5440, 330 Independence Avenue SW,, Washington, D.C. 20201, written com ments 'preferably in quintuplicate) re garding this proposal. Comments may be accompanied by a memorandum or brief in support thereof. In section 2 of the Fair Packaging and Labeling Act (Pub'ic Law 89-755: 80 St.it. 1296', which sets forth the intent of Con gress in enacting that legislation, it is stated that "Packages and their labels Dated; January 2, 1969. J. K. Kirk, Associate Commissioner for Compliance. should enable consumers to obtain ac [PR, Doc. 69-335; Filed, Jan, 9, 1969; curate information as to the quantity of 8:48 am.] the contents and should facilitate value comparisons." Section 4 of that net sets \ forth specific requirements for declaring r 21 CFR Part 128 1 quantity of contents. To implement such requirements, l.8b(a' of the regulations for the en forcement of said act prescribes that "Whenever the Commissioner determines that an existing practice of declaring net quantity of contents by weight, measure, numerical count, or a combination in the HUMAN FOODS; CURRENT GOOD MANUFACTURING PRACTICE (SAN ITATION) IN MANUFACTURE, PROCESSING, PACKING, OR HOLD ING Extension of Time for Filing Comments case of a specific packaged food does not facilitate value comparisons by con sumers and offers opportunity for con sumer confusion, he will by regulation designate the appropriate term or terms to be used for such commodity." A situation in 'the pickle industry that fosters consumer confusion has come to the attention of the Commissioner of Food and Drugs. For sliced pickles ar.d pickle relish, two methods are now being used to declare quantity of contents---by The proposal to promulgate Fart 128-- Human foods; current good manufactur ing practice <sanitation) in manufacture, processing, packing, or holding, pub lished in the Federal Recistcr of Decem ber 20, 1968 (33 F.R. 19023), provided for the filing of comments thereon within 30 days of its publication date. The Commissioner of Food and Drugs hr:; received a request, for an extension of such time and, good reason therefor, appearing, the time for filing comments weight and by volume, (In the case of one regarding proposed Part 128 is extended or two pickles packed in transparent to February 18, 1969. sealed plastic bags, however, a single This action is taken pursuant to the method of declaration by count is being provisions of the Federal Food, Drug, used.) For many years most packers of and Cosmetic Act (secs. 402(a)(4), pickle products have declared the quan 701(a), 52 Stat. 104G, 1055; 21 U.S.C. tity of contents in terms of volume. The 342(a) (4), 371(a)) and under authority declaration in terms of volume provides delegated to the Commissioner (21 CFR the consumer with accurate information and facilitates value comparisons. Therefore, the Commissioner on his own initiative proposes that the declara tion of quantity of contents be made uni form in volumetric terms on such products. Accordingly, pursuant to the provi sions of the Fair Packaging and Labeling Act (secs. 4, 5(a). 6(a), 80 Stat. 12971300; 15 U.S.C. 1453-55) and the Fed 2,120). Dated; December 30, 1968. J. K. Kirk, Associate Commissioner for Compliance. [F.R. Doc. 69-333; Filed, Jan. 9, 1969; 8:48 a.m.] Public Health Service eral Food, Drug, and Cosmetic Act (sec. 701, 52 Stat. 1055, as amended: 21 U.S.C. 371), and under authority delegated to the Commissioner (21 CFR 2,120), it is proposed that 51.8b be amended by add ing thereto a new paragraph, as follows; 1.8b rood Libeling; declaration of net quantity of contents; when exempt. t 42 CFR Part 81 ] AIR QUALITY CONTROL REGIONS Notice of Proposed Designation of Metropolitan Cincinnati Interstate Air Quality Control Region; Con sultation With Appropriate State end Local Authorities (r> The declaration of net quantity of contents on pickles and pickle products, including relishes but excluding one or two whole pickles in clear plastic bags. shall be expressed in terms of the U.S. gallon of 231 cubic inches and quart, Pursuant to authority delegated by the Secretary and redelegated to the Coin- misrioner of the National Air Pollution Control Administration (33 F.R. 9909). notice Is hereby given of a proposal to designate the -Metropolitan- Cincinnati In; .ate Air Quality Control Region as set faith in the following new 5 81.20 which would be added to Part 81 of Title 42, Code of Federal Regulations. It is proposed to make such designation effec tive upon republication. Interested persons may submit written data, views, or arguments in triplicate to the Office of the Commissioner. Na tional Air Pollution Control Administra tion, Ballston Center Tower n, Room 9D5, 801 North Randolph Street, Arling ton, Va, 22203. All relevant material re ceived not later than 30 days after the publication of this notice will be considered. Interested authorities of the States of Ohio, Kentucky, and Indiana, and ap propriate local authorities, both within and without the proposed region, who are affected by or Interested in the pro posed designation, are hereby given no tice of an opportunity to consult with representatives of the Secretary concern ing such designation. Such consultation will take place at the Federal Office Building, Room 8016, 550 Main Street, Cincinnati, Ohio 45202, beginning at 10 a.m., January 27,1969. Mr. Doyle J. Borchers is hereby des ignated as Chairman for the consul tation, The Chairman shall fix the time, date, and place of later sessions and may convene, reconvene,' recess, and adjourn the sessions as he deems ap propriate to expedite the proceedings. State and local authorities wishing to participate in the consultation should notify the Office of the Commissioner, National Air Pollution Control Admin istration, Ballston Center Tower II, Room 905, 801 North Randolph Street, Arlington, Va. 22203, of such intention by January 20,1969. A report prepared for the consulta tion, entitled "Report for Consultation on the Metropolitan Cincinnati Inter state Air Quality Control Region," is available upon request to the Office of the Commissioner, In Part 81 a new 5 81.20 is proposed to be added to read as follows: g 81.20 Metropolitan Cincinnati Inter- state Air Quality Control Region, The Metropolitan Cincinnati Inter state Air Quality Control Region con sists ot the territorial area encompassed by the boundaries of the following ju risdictions (including the territorial area of all municipalities (as defined In section 302(f) of the Clean Air Act, 42 U.S.C. 1857(f)) geographically lo cated within the outermost boundaries of the area so delimited); In the State of Ohio; Clermont County. Hamilton County. In the Commonwealth of Kentucky: Boone County. Cambell County. Kenton County. In the State of Indiana; Dearborn County. This action is proposed under the au thority of sections 107(a) and 301(a) of of the . Clean Air Act, section 2, Public No. T- FEOERAl REGISTER, VOL. 34, NO. 7--FRIOAV, JANUARY 10, 1969 ASI 00002323 PROPOSED RULE MAKING 10020 In nature may be published at any Umo without, prior notice. <d> The Department may. at any time after vrerlvlnif a recommended revlnlon or ft rccnmmcndcil amendment from ft BlnndliU! ('iuninltl.ro, and prior to puhll- cation, make ritltniiat or other minor tary Product Standards." Is not limited In ony wny by Uirso procedures. Dated: December 11, 11X10. .InllN I1'. ItlNOAtlt, Aiilatimt .VcriWori/ /or ftvlriirr nntl TrrlivnUuitl- Wnnhhilttnn. DC. 2020't. Additional six'rinr rri'iiliil.loM'-, (".l.nblklilnir criteria (or partli'iiliir f:< i-(r,< (11;< i,r 1.11- rn.,,1 Iiidllnl.ry Will lift Hie Mlli|i rl, i,r ni,|>i iiilli'i'i! 1,(1 l.lftvift fti'tft'iiil Irftiilftl.liftci. Thftifthftiiti(Mini(11. t,o lift* |ii,,vl';Wftfti of l.hft Art, (r.tM'ft 4ii',`hi ` < I >. 'IIiDmi. r.i: rhaPnen whleh are deemed neeennnvy to tr.tt, >>oc. an mini: mn*t. tiee. in, tomu iti.nl. linn, mi,!; ;:i u r.c :ii.:ini, redure iPnlilipdl.y or Improve elnrll.y 11;47 mil,I X/l lil> < (mil nnili'i iiIiI Imii ]I v il. l. rnI, ,| l,n Wllllln the .-ilmuliti'd: I'ronWeif, //ot/x'l'cr, him 121 (.`l,,lt `.l.r.MH, lift- I IiiiimiiIi .'ildift'i' That no Mili.I.eul.lve changes shall bo propone.': Unit a new I'ail 1 HU lie added DEPARTMENT OF HEALTH, EDU-made In the standard. IP.11 Wiilnlrnwnl of n pnldislinl rlnod- to Title 21, Chapter I, as follows: PART 128--HUMAN FOODS; CUR tird. , CATION, AND WELFARE(a) Any standard published under RENT GOOD MANUFACTURING PRACTICE (SANITATION) IN MAN these or any previous procedures may be withdrawn by the Department at any time. Such action will be taken, if, after consultation with the Standing Com mittee. as provided in paragraph (b> of this section, and after public notice, the Department determines that the stand ard is obsolete, technically inadequate, no longer generally acceptable to and Food and Drug Administration t 21 CFR Part 128 1 HUMAN FOODS Current Good Manufacturing Practice ISanitation) in Manufacturing, Proc essing, Packing, or Holding UFACTURE, PROCESSING, PACK ING, OR HOLDING Bee. 128.1 Definitions. 128.2 Current good manufacturing practice (sanitation). 128a Plant and grounds. 138.4 Equipment and utensiles. 128.5 Sanitary facilities and controls. used by the Industry, Inconsistent with law or established public policy, not in the public interest, or otherwise Inap propriate, and revision or amendment Is not feasible or would serve no useful purpose. In the FxemM. Racism of Decem ber 15, 1067 (32 F.R. 17080), the Com missioner of Food and Drugs proposed the promulgation of Part 128 covering current good manufacturing practice 128.8 Sanitary operations. 128.7 Processes and controls. 128.8 Personnel. AuTHoarrr: The provisions of this Part 128 issued under secs. 402(a) (4), 701(a). 52 Stt. 1046, 1055; 21 Ufi.C. 343(a)(4), 371(a). (b) Before withdrawing a published standard the Department will review the yaiAt-;,,'* advav.i and dluadvaut aftea (sanitation) in the manufacture, proc essing, packing, or holding of human foods OsmmentJi were received in re*- 12<t.l Definitions. TV.ft daflr.USmus tnrl line-jiviniuSniia, -P! itiute.rfui.ie.e. MP'uiiui , OevOiOpitiCtiL of -wjdj'.ij*: i-.evrf.v v'mcJ:. .tii'-e wmilx.'C lU eo'.ittu'.ftrt in wastiur 201 v. J-vdonJ ft now aUiuofttd. 01 withdrawal, with the significant changet in the proposed regu Food, Drue, and Cosmetic Act are appli members of the Standing Committee for lations, and the Commissioner concludes cable to such terms when used in this that standard, if such committee was ap pointed within the previous 5 years. that a revised proposal should be pub lished as set forth below. part. The following definitions shall`also apply: (c> Public notice of intent to with These regulations would establish cri (a) "Adequate" means that which is draw an existing standard will be given teria for good manufacturing practices needed to accomplish the intended pur and a 30-day period will be provided for . for effective sanitation control In the pose in keeping with good public health the filing of written objections to the manufacture, processing, packing, or practice. withdrawal. Such objections to the with drawal will be considered and analyzed by the Department before a final de cision is made to withdraw the stand ard. The Department will give public notice of the withdrawal of an existing standard not less than 60 days prior to the effective date of such withdrawal, (d) Withdrawal will terminate the au thority to refer to the published stand ard as a voluntary standard developed under Department of Commerce pro cedures, from the effective date of the withdrawal. holding of human foods to effect com pliance with section 402(a) (4) of the Federal Food, Drug, and Cosmetic Act. They set forth standards of sanitary food processing that would result In a clean and wholesome end product. Some of these standards are expressed In mandatory terms; others are directory. All should be observed to satisfy the re quirements of current good sanitation practice in food processing and holding. While these regulations would estab lish general criteria.for the human food industry, they would not apply to those establishments engaged solely in the (b) "Readily cleanable" means acces sible and of such design, material, and finish that residues from or caused by processing operations may be removed by normal in-place or disassembly clean ing methods. (c) "Plant" means the building or buildings, or parts thereof, used for or in connection with the manufacturing, processing, packaging, labeling, or hold ing of human food, (d) "Sanitize" means adequate treat ment of surfaces by a process that is ef fective in destroying vegetative cells of 10.12 Effect of procedures. harvesting, storage, or distribution of one pathogenic bacteria and in substantially These procedures supersede all com or more raw agricultural commodities, as reducing other micro-organisms. Such modity standards procedures previously defined In section 201 (r) of the Act, treatment shall not adversely affect the Issued by the Department of Commerce which are ordinarily cleaned, prepared, product and shall be safe for the or any of its offices or bureaus, but cur treated, and/or otherwise processed be consumer. rent commodity standards published un der any such superseded procedures will remain In effect as Voluntary Product Standards. Nothing contained in these procedures shall be deemed to apply to the development, publication, revision, amendment, or withdrawal of any stand ard which is not identified as a "Volun tary Product Standard" by the Depart ment. The authority of the Department fore being marketed to the consuming public. The Commissioner believes that if necessary special regulations should be developed for operations In this category. Any interested person not within the exception for raw agricultural commodi ties, who believes circumstances warrant an exception and special regulations for his operation, may submit a request for I 128.2 Current good manufacturing practice (sanitation). The criteria in 19128.3 through 128.8 shall apply in determining whether the facilities, methods, practices, and con trols used In the manufacture, processing, packing, or holding of food are in con formance with or are operated or ad ministered in conformity with good man. with respect to engineering standards exception together with a written justi ufacturing practices to assure that food activities generally, including the au fication In support of the request ad for human consumption has been pre thority to publish appropriate recom dressed to the Commissioner, Food and pared. packed, and held under sanitary mendations not identified as "Volun Drug Administration, 300 C Street 8W,, conditions. MOCtAl MOUTH, VOL >3, NO. 247--FtlOAY, DfCEMBIt 20, 19M l ASI 00002324