Emergency permit control (Food safety) (21 CFR 108.3-108.35)

200 21 CFR Ch. I (4–1–11 Edition) § 107.260 The agency will send such a notifica tion unless it has information, from FDA’s own audits or from other sources, demonstrating that the recall has not been effective. The agency may conclude that a recall has not been ef fective if: (a) The recalling firm’s distributors have failed to retrieve the recalled in fant formula; or (b) Stocks of the recalled infant for mula remain in distribution channels that are not in direct control of the re calling firm. [54 FR 4008, Jan. 27, 1989, as amended at 61 FR 14479, Apr. 2, 1996; 66 FR 17359, Mar. 30, 2001; 69 FR 17291, Apr. 2, 2004] § 107.260 Revision of an infant formula recall. If after a review of the recalling firm’s recall strategy or periodic re ports or other monitoring of the recall, the Food and Drug Administration con cludes that the actions of the recalling firm are deficient, the agency shall no tify the recalling firm of any serious deficiency. The agency may require the firm to: (a) Change the extent of the recall, if the agency concludes on the basis of available data that the depth of the re call is not adequate in light of the risk to human health presented by the in fant formula. (b) Carry out additional effectiveness checks, if the agency’s audits, or other information, demonstrate that the re call has not been effective. (c) Issue additional notifications to the firm’s direct accounts, if the agen cy’s audits, or other information dem onstrate that the original notifications were not received, or were disregarded in a significant number of cases. § 107.270 Compliance with this sub part. A recalling firm may satisfy the re quirements of this subpart by any means reasonable calculated to meet the obligations set forth in this Sub part E. The recall guidance in subpart C of part 7 of this chapter specify pro cedures that may be useful to a recall ing firm in determining how to comply with these regulations. [54 FR 4008, Jan. 27, 1989, as amended at 65 FR 56479, Sept. 19, 2000] § 107.280 Records retention. Each manufacturer of an infant for mula shall make and retain such records respecting the distribution of the infant formula through any estab lishment owned or operated by such manufacturer as may be necessary to effect and monitor recalls of the for mula. Such records shall be retained for at least 1 year after the expiration of the shelf life of the infant formula. [54 FR 4008, Jan. 27, 1989, as amended at 67 FR 9585, Mar. 4, 2002] PART 108—EMERGENCY PERMIT CONTROL Subpart A—General Provisions Sec. 108.3 Definitions. 108.5 Determination of the need for a per mit. 108.6 Revocation of determination of need for permit. 108.7 Issuance or denial of permit. 108.10 Suspension and reinstatement of per mit. 108.12 Manufacturing, processing, or pack ing without a permit, or in violation of a permit. 108.19 Establishment of requirements for ex emption from section 404 of the act. Subpart B—Specific Requirements and Conditions for Exemption From or Compliance With an Emergency Per mit 108.25 Acidified foods. 108.35 Thermal processing of low-acid foods packaged in hermetically sealed con tainers. AUTHORITY: 21 U.S.C. 342, 344, 371. SOURCE: 42 FR 14334, Mar. 15, 1977, unless otherwise noted. Subpart A—General Provisions § 108.3 Definitions. (a) The definitions contained in sec tion 201 of the Federal Food, Drug, and Cosmetic Act are applicable to such terms when used in this part. (b) Commissioner means the Commis sioner of Food and Drugs. (c) Act means the Federal Food, Drug, and Cosmetic Act, as amended. (d) Permit means an emergency per mit issued by the Commissioner pursu ant to section 404 of the act for such VerDate Mar<15>2010 13:44 Apr 26, 2011 Jkt 223066 PO 00000 Frm 00210 Fmt 8010 Sfmt 8010 Y:\SGML\223066.XXX 223066W R e ie r A vi le s o n D S K G B L S 3 C 1 P R O D w ith C F R 201 Food and Drug Administration, HHS § 108.7 temporary period of time as may be necessary to protect the public health. (e) Manufacture, processing, or packing of food in any locality means activities conducted in a single plant or estab lishment, a series of plants under a sin gle management, or all plants in an in dustry or region, by a manufacturer, processor, or packer. § 108.5 Determination of the need for a permit. (a) Whenever the Commissioner de termines after investigation that a manufacturer, processor, or packer of a food for which a regulation has been promulgated in subpart B of this part does not meet the mandatory condi tions and requirements established in such regulation, he shall issue to such manufacturer, processor, or packer an order determining that a permit shall be required before the food may be in troduced or delivered for introduction into interstate commerce by that per son. The order shall specify the manda tory conditions and requirements with which there is a lack of compliance. (1) The manufacturer, processor, or packer shall have 3 working days after receipt of such order within which to file objections. Such objections may be filed by telegram, telex, or any other mode of written communication ad dressed to the Center for Food Safety and Applied Nutrition, Food and Drug Administration (HFS–605), 5100 Paint Branch Pkwy., College Park, MD 20740. If such objections are filed, the deter mination is stayed pending a hearing to be held within 5 working days after the filing of objections on the issues in volved unless the Commissioner deter mines that the objections raise no gen uine and substantial issue of fact to justify a hearing. (2) If the Commissioner finds that there is an imminent hazard to health, the order shall contain this finding and the reasons therefor, and shall state that the determination of the need for a permit is effective immediately pend ing an expedited hearing. (b) A hearing under this section shall be conducted by the Commissioner or his designee at a location agreed upon by the objector and the Commissioner or, if such agreement cannot be reached, at a location designated by the Commissioner. The manufacturer, processor, or packer shall have the right to cross-examine the Food and Drug Administration’s witnesses and to present witnesses on his own behalf. (c) Within 5 working days after the hearing, and based on the evidence pre sented at the hearing, the Commis sioner shall determine whether a per mit is required and shall so inform the manufacturer, processor, or packer in writing, with the reasons for his deci sion. (d) The Commissioner’s determina tion of the need for a permit con stitutes final agency action from which appeal lies to the courts. The Commis sioner will not stay a determination of the need for a permit pending court ap peal except in unusual circumstances, but will participate in expediting any such appeal. [42 FR 14334, Mar. 15, 1977, as amended at 54 FR 24891, June 12, 1989; 61 FR 14479, Apr. 2, 1996; 66 FR 56035, Nov. 6, 2001] § 108.6 Revocation of determination of need for permit. (a) A permit shall be required only during such temporary period as is nec essary to protect the public health. (b) Whenever the Commissioner has reason to believe that a permit holder is in compliance with the mandatory requirements and conditions estab lished in subpart B of this part and is likely to remain in compliance, he shall, on his own initiative or on the application of the permit holder, re voke both the determination of need for a permit and the permit that had been issued. If denied, the applicant shall, upon request, be afforded a hear ing conducted in accordance with § 108.5 (b) and (c) as soon as practicable. Such revocation is without prejudice to the initiation of further permit pro ceedings with respect to the same man ufacturer, processor, or packer should later information again show the need for a permit. § 108.7 Issuance or denial of permit. (a) After a determination and notifi cation by the Commissioner in accord ance with the provisions of § 108.5 that a manufacturer, processor, or packer requires a permit, such manufacturer, VerDate Mar<15>2010 13:44 Apr 26, 2011 Jkt 223066 PO 00000 Frm 00211 Fmt 8010 Sfmt 8010 Y:\SGML\223066.XXX 223066W R e ie r A vi le s o n D S K G B L S 3 C 1 P R O D w ith C F R 202 21 CFR Ch. I (4–1–11 Edition) § 108.10 processor, or packer may not there after introduce or deliver for introduc tion into interstate commerce any such food manufactured, processed, or packed by him unless he holds a permit issued by the Commissioner or obtains advance written approval of the Food and Drug Administration pursuant to § 108.12(a). (b) Any manufacturer, processor, or packer for whom the Commissioner has made a determination that a permit is necessary may apply to the Commis sioner for the issuance of such a per mit. The application shall contain such data and information as is necessary to show that all mandatory requirements and conditions for the manufacturer, processing or packing of a food for which regulations are established in subpart B of this part are met and, in particular, shall show that the devi ations specified in the Commissioner’s determination of the need for a permit have been corrected or suitable interim measures established. Within 10 work ing days after receipt of such applica tion, (except that the Commissioner may extend such time an additional 10 working days where necessary), the Commissioner shall issue a permit, deny the permit, or offer the applicant a hearing conducted in accordance with § 108.5 (b) and (c) as to whether the per mit should be issued. The Commis sioner shall issue such a permit to which shall be attached, in addition to the mandatory requirements and con ditions of subpart B of this part, any additional requirements or conditions which may be necessary to protect the public health if he finds that all man datory requirements and conditions of subpart B of this part are met or suit able interim measures are established. (c) Denial of a permit constitutes final agency action from which appeal lies to the courts. The Commissioner will not stay such denial pending court appeal except in unusual cir cumstances, but will participate in ex pediting any such appeal. § 108.10 Suspension and reinstatement of permit. (a) Whenever the Commissioner finds that a permit holder is not in compli ance with the mandatory requirements and conditions established by the per mit, he shall immediately suspend the permit and so inform the permit hold er, with the reasons for the suspension. (b) Upon application for reinstate ment of a permit, the Commissioner shall, within 10 working days, reinstate the permit if he finds that the person is in compliance with the mandatory re quirements and conditions established by the permit or deny the application. (c) Any person whose permit has been suspended or whose application for re instatement has been denied may re quest a hearing. The hearing shall be conducted by the Commissioner or his designee within 5 working days of re ceipt of the request at a location agreed upon by the objector and the Commissioner or, if an agreement can not be reached, at a location des ignated by the Commissioner. The per mit holder shall have the right to present witnesses on his own behalf and to cross-examine the Food and Drug Administration’s witnesses. (d) Within 5 working days after the hearing, and based on the evidence pre sented at the hearing, the Commis sioner shall determine whether the per mit shall be reinstated and shall so in form the permit holder, with the rea sons for his decision. (e) Denial of an application for rein statement of a permit constitutes final agency action from which appeal lies to the courts. The Commisioner will not stay such denial pending court ap peal except in unusual circumstances, but will participate in expediting any such appeal. § 108.12 Manufacturing, processing, or packing without a permit, or in vio lation of a permit. (a) A manufacturer, processor, or packer may continue at his own risk to manufacture, process, or pack without a permit a food for which the Commis sioner has determined that a permit is required. All food so manufactured, processed, or packed during such period without a permit shall be retained by the manufacturer, processor, or packer and may not be introduced or delivered for introduction into interstate com merce without the advance written ap proval of the Food and Drug Adminis tration. Such approval may be granted only upon an adequate showing that VerDate Mar<15>2010 13:44 Apr 26, 2011 Jkt 223066 PO 00000 Frm 00212 Fmt 8010 Sfmt 8010 Y:\SGML\223066.XXX 223066W R e ie r A vi le s o n D S K G B L S 3 C 1 P R O D w ith C F R 203 Food and Drug Administration, HHS § 108.25 such food is free from microorganisms of public health significance. The man ufacturer, processor, or packer may provide to the Commissioner, for his consideration in making any such de termination, an evaluation of the po tential public health significance of such food by a competent authority in accordance with procedures recognized as being adequate to detect any poten tial hazard to public health. Within 20 working days after receipt of a written request for such written approval the Food and Drug Administration shall ei ther issue such written approval or deny the request. If the request is de nied, the applicant shall, upon request, be afforded a prompt hearing con ducted in accordance with § 108.5 (b) and (c). (b) Except as provided in paragraph (a) of this section, no manufacturer, processor, or packer may introduce or deliver for introduction into interstate commerce without a permit or in viola tion of a permit a food for which the Commissioner has determined that a permit is required. Where a manufac turer, processor, or packer utilizes a consolidation warehouse or other stor age facility under his control, inter state shipment of any such food from the point of production to that ware house or storage facility shall not vio late this paragraph, provided that no further introduction or delivery for in troduction into interstate commerce is made from that consolidated ware house or storage facility except as pro vided in paragraph (a) of this section. § 108.19 Establishment of require ments for exemption from section 404 of the act. (a) Whenever the Commissioner finds after investigation that the distribu tion in interstate commerce of any class of food may, by reason of con tamination with microorganisms dur ing the manufacture, processing, or packing thereof in any locality, be in jurious to health, and that such inju rious nature cannot be adequately de termined after such articles have en tered interstate commerce, he shall promulgate regulations in Subpart B of this part establishing requirements and conditions governing the manufacture, processing, or packing of the food nec essary to protect the public health. Such regulations may be proposed by the Commissioner on his own initiative or in response to a petition from any interested person pursuant to part 10 of this chapter. (b) A manufacturer, processor, or packer of a food for which a regulation has been promulgated in subpart B of this part shall be exempt from the re quirement for a permit only if he meets all of the mandatory requirements and conditions established in that regula tion. [42 FR 14334, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977] Subpart B—Specific Requirements and Conditions for Exemption From or Compliance With an Emergency Permit § 108.25 Acidified foods. (a) Inadequate or improper manufac ture, processing, or packing of acidified foods may result in the distribution in interstate commerce of processed foods that may be injurious to health. The harmful nature of such foods cannot be adequately determined after these foods have entered into interstate com merce. The Commissioner of Food and Drugs therefore finds that, to protect the public health, it may be necessary to require any commericial processor, in any establishment engaged in the manufacture, processing, or packing of acidified foods, to obtain and hold a temporary emergency permit provided for under section 404 of the Federal Food, Drug, and Cosmetic Act. Such a permit may be required whenever the Commissioner finds, after investiga tion, that the commercial processor has failed to fulfill all the require ments of this section, including reg istration and filing of process informa tion, and the mandatory portions of §§ 114.10, 114.80(a) (1) and (2), and (b), 114.83, 114.89, and 114.100 (b), (c), and (d) of this chapter as they relate to acidi fied foods. These requirements are in tended to ensure safe manufacturing, processing, and packing processes and to permit the Food and Drug Adminis tration to verify that these processes are being followed. Failure to meet these requirements shall constitute a VerDate Mar<15>2010 13:44 Apr 26, 2011 Jkt 223066 PO 00000 Frm 00213 Fmt 8010 Sfmt 8010 Y:\SGML\223066.XXX 223066W R e ie r A vi le s o n D S K G B L S 3 C 1 P R O D w ith C F R 204 21 CFR Ch. I (4–1–11 Edition) § 108.25 prima facie basis for the immediate ap plication of the emergency permit con trol provisions of section 404 of the act to that establishment, under the proce dures established in subpart A of this part. (b) The definitions in § 114.3 of this chapter are applicable when those terms are used in this section. (c)(1) Registration. A commercial processor, when first engaging in the manufacture, processing, or packing of acidified foods in any State, as defined in section 201(a)(1) of the act, shall, not later than 10 days after first so engag ing, register and file with the Food and Drug Administration on Form FDA 2541 (food canning establishment reg istration) information including, but not limited to, the name of the estab lishment, principal place of business, the location of each establishment in which that processing is carried on, the processing method in terms of acidity and pH control, and a list of foods so processed in each establishment. These forms are available from the LACF Registration Coordinator (HFS–618), Center for Food Safety and Applied Nu trition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or at any Food and Drug Ad ministration district office. The com pleted form shall be submitted to the Center for Food Safety and Applied Nu trition (HFS–565), Food and Drug Ad ministration, 5100 Paint Branch Pkwy., College Park, MD 20740. Commercial processors presently so engaged shall register within 120 days after the effec tive date of this regulation. Foreign processors shall register within 120 days after the effective date of this reg ulation or before any offering of foods for import into the United States, whichever is later. Commercial proc essors duly registered under this sec tion shall notify the Food and Drug Administration not later than 90 days after the commercial processor ceases or discontinues the manufacture, proc essing, or packing of the foods in any establishment, except that this notifi cation shall not be required for tem porary cessations due to the seasonal character of an establishment’s produc tion or by temporary conditions in cluding, but not limited to, labor dis putes, fire, or acts of God. (2) Process filing. A commercial proc essor engaged in the processing of acidified foods shall, not later than 60 days after registration, and before packing any new product, provide the Food and Drug Administration infor mation on the scheduled processes in cluding, as necessary, conditions for heat processing and control of pH, salt, sugar, and preservative levels and source and date of the establishment of the process, for each acidified food in each container size. Filing of this in formation does not constitute approval of the information by the Food and Drug Administration, and information concerning processes and other data so filed shall be regarded as trade secrets within the meaning of 21 U.S.C. 331(j) and 18 U.S.C. 1905. This information shall be submitted on form FDA 2541a (food canning establishment process filing form for all methods except asep tic). Forms are available from the LACF Registration Coordinator (HFS– 618), Center for Food Safety and Ap plied Nutrition, Food and Drug Admin istration, 5100 Paint Branch Pkwy., College Park, MD 20740, or at Food and Drug Administration district office. The completed form shall be submitted to the LACF Registration Coordinator (HFS–618), Center for Food Safety and Applied Nutrition, Food and Drug Ad ministration, 5100 Paint Branch Pkwy., College Park, MD 20740. (3) Process adherence and information— (i) Scheduling. A commercial processor engaged in processing acidified foods in any registered establishment shall process each food in conformity with at least the scheduled processes filed under paragraph (c)(2) of this section. (ii) Process and pH information avail ability. When requested by the Food and Drug Administration in writing, a commercial processor engaged in the processing of acidified foods shall pro vide the Food and Drug Administration with any process and procedure infor mation that the Food and Drug Admin istration deems necessary to determine the adequacy of the process. Fur nishing of this information does not constitute approval by the Food and Drug Administration of the content of the information filed, and the informa tion concerning processes and other data so furnished shall be considered VerDate Mar<15>2010 13:44 Apr 26, 2011 Jkt 223066 PO 00000 Frm 00214 Fmt 8010 Sfmt 8010 Y:\SGML\223066.XXX 223066W R e ie r A vi le s o n D S K G B L S 3 C 1 P R O D w ith C F R 205 Food and Drug Administration, HHS § 108.25 trade secrets within the meaning of 21 U.S.C. 331(j) and 18 U.S.C. 1905 (to the extent that they qualify under those provisions). (d) A commercial processor engaged in the processing of acidified foods shall promptly report to the Food and Drug Administration any instance of spoilage, process deviation, or con tamination with microorganisms, the nature of which has potential health endangering significance, where any lot of such food has in whole or in part entered distribution in commerce. (e) A commercial processor engaged in the processing of acidified foods shall prepare and maintain files on a current procedure for use for products under the processor’s control, which that processor will ask the distributor to follow, including plans for recalling products that may be injurious to health; for identifying, collecting, warehousing, and controlling products; for determining the effectiveness of re calls; for notifying the Food and Drug Administration of any recalls; and for implementing recall programs. (f) All plant personnel involved in acidification, pH control, heat treat ment, or other critical factors of the operation shall be under the operating supervision of a person who has at tended a school approved by the Com missioner for giving instruction in food-handling techniques, food protec tion principles, personal hygiene, plant sanitation practices, pH controls, and critical factors in acidification, and who has satisfactorily completed the prescribed course of instruction. The Commissioner will consider students who have satisfactorily completed the required portions of the courses pre sented under § 108.35 and part 113 of this chapter before March 16, 1979, as having satisfactorily completed the prescribed course of instruction under this section and part 114 of this chapter. The Com missioner will not withhold approval of any school qualified to give such in struction. (g) A commercial processor engaged in the processing of acidified foods shall prepare, review, and retain at the processing plant or other reasonably accessible location for a period of 3 years from the date of manufacture, all records of processing, deviations in processing, pH, and other records speci fied in part 114 of this chapter. Upon written demand during the course of a factory inspection under section 704 of the act by a duly authorized employee of the Food and Drug Administration, a commercial processor shall permit the inspection and copying by that em ployee of these records to verify the pH and the adequacy of processing. (h) This section shall not apply to the commercial processing of any food processed under the continuous inspec tion of the meat and poultry inspection program of the Food Safety and Inspec tion Service of the Department of Agri culture under the Federal Meat Inspec tion Act (34 Stat. 1256, as amended by 81 Stat. 584 (21 U.S.C. 601 et seq.)) and the Poultry Products Inspection Act (71 Stat. 441, as amended by 82 Stat. 791 (21 U.S.C. 451 et seq.)). (i) Wherever the Commissioner finds that any State regulates the commer cial processing of acidified foods under effective regulations specifying at least the requirements of part 114 of this chapter, the Commissioner shall issue a notice stating that compliance with such State regulations shall constitute compliance with this section, if the State through its regulatory agency or each processor of acidified foods in the State files with the Food and Drug Ad ministration the registration informa tion and the processing information prescribed in paragraph (c) of this sec tion. (j) Imports: (1) This section applies to any foreign commercial processor en gaged in the processing of acidified foods and offering those foods for im port into the United States except that, in lieu of providing for the issuance of an emergency permit under paragraph (a) of this section, the Com missioner will request the Secretary of the Treasury to refuse admission into the United States, under section 801 of the act, to any acidified foods which the Commissioner determines, after in vestigation, may result in the distribu tion in interstate commerce of proc essed foods that may be injurious to health as set forth in paragraph (a) of this section. (2) Any acidified food so refused ad mission shall not be admitted until the Commissioner determines that the VerDate Mar<15>2010 13:44 Apr 26, 2011 Jkt 223066 PO 00000 Frm 00215 Fmt 8010 Sfmt 8010 Y:\SGML\223066.XXX 223066W R e ie r A vi le s o n D S K G B L S 3 C 1 P R O D w ith C F R 206 21 CFR Ch. I (4–1–11 Edition) § 108.35 commercial processor offering the food for import has complied with the re quirements of this section and that the food is not injurious to health. To as sist the Commissioner in making this determination, a duly authorized em ployee of the Food and Drug Adminis tration shall be permitted to inspect the commercial processor’s manufac turing, processing, and packing facili ties. (k) The following information sub mitted to the Food and Drug Adminis tration under this section is not avail able for public disclosure unless it has been previously disclosed to the public as defined in § 20.81 of this chapter or it relates to a product or ingredient that has been abandoned and no longer rep resents a trade secret or confidential commercial or financial information as defined in § 20.61 of this chapter: (1) Manufacturing methods or proc esses, including quality control infor mation. (2) Production, sales, distribution, and similar information, except that any compilation of the information ag gregated and prepared in a way that does not reveal information which is not available for public disclosure under this provision is available for public disclosure. (3) Quantitative or semiquantitative formulas. [44 FR 16207, Mar. 16, 1979, as amended at 54 FR 24891, June 12, 1989; 61 FR 14479, Apr. 2, 1996; 66 FR 56035, Nov. 6, 2001] § 108.35 Thermal processing of low acid foods packaged in hermetically sealed containers. (a) Inadequate or improper manufac ture, processing, or packing of ther mally processed low-acid foods in her metically sealed containers may result in the distribution in interstate com merce of processed foods that may be injurious to health. The harmful na ture of such foods cannot be adequately determined after these foods have en tered into interstate commerce. The Commissioner of Food and Drugs there fore finds that, in order to protect the public health, it may be necessary to require any commercial processor, in any establishment engaged in the man ufacture, processing, or packing of thermally processed low-acid foods in hermetically sealed containers, to ob tain and hold a temporary emergency permit provided for under section 404 of the Federal Food, Drug, and Cosmetic Act. Such a permit may be required whenever the Commissioner finds, after investigation, that the commercial processor has failed to fulfill all the re quirements of this section, including registration and the filing of process information, and the mandatory por tions of part 113 of this chapter. These requirements are intended to ensure safe manufacture, processing, and packing procedures and to permit the Food and Drug Administration to verify that these procedures are being followed. Such failure shall constitute a prima facie basis for the immediate application of the emergency permit control provisions of section 404 of the act to that establishment, pursuant to the procedures established in subpart A of this part. (b) The definitions in § 113.3 of this chapter are applicable when such terms are used in this section. (c) Registration and process filing—(1) Registration. A commercial processor when first engaging in the manufac ture, processing, or packing of ther mally processed low-acid foods in her metically sealed containers in any state, as defined in section 201(a)(1) of the act, shall, not later than 10 days after first so engaging, register with the Food and Drug Administration on Form FDA 2541 (food canning establish ment registration) information includ ing (but not limited to) his name, prin cipal place of business, the location of each establishment in which such proc essing is carried on, the processing method in terms of the type of proc essing equipment employed, and a list of the low-acid foods so processed in each such establishment. These forms are available from the LACF Registra tion Coordinator (HFS–618), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or at any Food and Drug Admin istration district office. The completed form shall be submitted to the LACF Registration Coordinator (HFS–618), Center for Food Safety and Applied Nu trition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, VerDate Mar<15>2010 13:44 Apr 26, 2011 Jkt 223066 PO 00000 Frm 00216 Fmt 8010 Sfmt 8010 Y:\SGML\223066.XXX 223066W R e ie r A vi le s o n D S K G B L S 3 C 1 P R O D w ith C F R 207 Food and Drug Administration, HHS § 108.35 MD 20740. Commercial processors pres ently so engaged shall register not later than July 13, 1973. Commercial processors duly registered in accord ance with this section shall notify the Food and Drug Administration not later than 90 days after such commer cial processor ceases or discontinues the manufacture, processing, or pack ing of thermally processed foods in any establishment: Provided, That such no tification shall not be required as to the temporary cessation necessitated by the seasonal character of the par ticular establishment’s production or caused by temporary conditions includ ing but not limited to strikes, lockouts, fire, or acts of God. (2) Process filing. A commercial proc essor engaged in the thermal proc essing of low-acid foods packaged in hermetically sealed containers shall, not later than 60 days after registra tion and prior to the packing of a new product, provide the Food and Drug Administration information as to the scheduled processes including but not limited to the processing method, type of retort or other thermal processing equipment employed, minimum initial temperatures, times and temperatures of processing, sterilizing value (Fo), or other equivalent scientific evidence of process adequacy, critical control fac tors affecting heat penetration, and source and date of the establishment of the process, for each such low-acid food in each container size: Provided, That the filing of such information does not constitute approval of the information by the Food and Drug Administration, and that information concerning proc esses and other data so filed shall be regarded as trade secrets within the meaning of 21 U.S.C. 331(j) and 18 U.S.C. 1905. This information shall be submitted on the following forms as appropriate: Form FDA 2541a (food can ning establishment process filing for all methods except aseptic), or Form FDA 2541c (food canning establishment process filing for aseptic systems). These forms are available from the LACF Registration Coordinator (HFS– 618), Center for Food Safety and Ap plied Nutrition, Food and Drug Admin istration, 5100 Paint Branch Pkwy., College Park, MD 20740, or at any Food and Drug Administration district of fice. The completed form(s) shall be submitted to the LACF Registration Coordinator (HFS–618), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. (i) If all the necessary information is not available for existing products, the processor shall, at the time the exist ing information is provided to the Food and Drug Administration request in writing an extension of time for sub mission of such information, specifying what additional information is to be supplied and the date by which it is to be submitted. Within 30 working days after receipt of such request the Food and Drug Administration shall either grant or deny such request in writing. (ii) If a packer intentionally makes a change in a previously filed scheduled process by reducing the initial tem perature or retort temperature, reduc ing the time of processing, or changing the product formulation, the container, or any other condition basic to the ade quacy of scheduled process, he shall prior to using such changed process ob tain substantiation by qualified sci entific authority as to its adequacy. Such substantiation may be obtained by telephone, telegram, or other media, but must be promptly recorded, verified in writing by the authority, and contained in the packer’s files for review by the Food and Drug Adminis tration. Within 30 days after first use, the packer shall submit to the Center for Food Safety and Applied Nutrition (HFS–617), Food and Drug Administra tion, 5100 Paint Branch Pkwy., College Park, MD 20740 a complete description of the modifications made and utilized, together with a copy of his file record showing prior substantiation by a qualified scientific authority as to the safety of the changed process. Any in tentional change of a previously filed scheduled process or modification thereof in which the change consists solely of a higher initial temperature, a higher retort temperature, or a longer processing time, shall not be considered a change subject to this paragraph, but if that modification is thereafter to be regularly scheduled, the modified process shall be promptly VerDate Mar<15>2010 13:44 Apr 26, 2011 Jkt 223066 PO 00000 Frm 00217 Fmt 8010 Sfmt 8010 Y:\SGML\223066.XXX 223066W R e ie r A vi le s o n D S K G B L S 3 C 1 P R O D w ith C F R 208 21 CFR Ch. I (4–1–11 Edition) § 108.35 filed as a scheduled process, accom panied by full information on the speci fied forms as provided in this para graph. (iii) Many packers employ an ‘‘oper ating’’ process in which retort opera tors are instructed to use retort tem peratures and/or processing times slightly in excess of those specified in the scheduled process as a safety factor to compensate for minor fluctuations in temperature or time to assure that the minimum times and temperatures in the scheduled process are always met. This would not constitute a modi fication of the scheduled process. (3) Process adherence and information. (i) A commercial processor engaged in the thermal processing of low-acid foods packaged in hermetically sealed containers in any registered establish ment shall process each low-acid food in each container size in conformity with at least the scheduled processes and modifications filed pursuant to paragraph (c)(2) of this section. (ii) Process information availability: When requested by the Food and Drug Administration in writing, a commer cial processor engaged in thermal proc essing of low-acid foods packaged in hermetically sealed containers shall provide the Food and Drug Administra tion with any information concerning processes and procedures which is deemed necessary by the Food and Drug Administration to determine the adequacy of the process: Provided, That the furnishing of such information does not constitute approval of the informa tion by the Food and Drug Administra tion, and that the information con cerning processes and other data so furnished shall be regarded as trade se crets within the meaning of 21 U.S.C. 331(j) and 18 U.S.C. 1905. (d) A commercial processor engaged in the thermal processing of low-acid foods packaged in hermetically sealed containers shall promptly report to the Food and Drug Administration any in stance of spoilage or process deviation the nature of which indicates potential health significance where any lot of such food has in whole or in part en tered distribution. (e) A commercial processor engaged in thermal processing of low-acid foods packaged in hermetically sealed con tainers shall promptly report to the Food and Drug Administration any in stance wherein any lot of such food, which may be injurious to health by reason of contamination with micro organisms, has in whole or in part en tered distribution. (f) A commercial processor engaged in the thermal processing of low-acid foods packaged in hermetically sealed containers shall have prepared and in his files a current procedure which he will use for products under his control and which he will ask his distributor to follow, including plans for effecting re calls of any product that may be inju rious to health; for identifying, col lecting, warehousing, and controlling the product; for determining the effec tiveness of such recall; for notifying the Food and Drug Administration of any such recall; and for implementing such recall program. (g) All operators of retorts, thermal processing systems, aseptic processing and packaging systems, or other ther mal processing systems, and container closure inspectors shall be under the operating supervision of a person who has attended a school approved by the Commissioner for giving instruction in retort operations, aseptic processing and packaging systems operations or other thermal processing systems oper ations, and container closure inspec tions, and has satisfactorily completed the prescribed course of instruction: Provided, That this requirement shall not apply in the State of California as listed in paragraph (j) of this section. The Commissioner will not withhold approval of any school qualified to give such instruction. (h) A commercial processor engaged in the thermal processing of low-acid foods packaged in hermetically sealed containers shall prepare, review, and retain at the processing plant for a pe riod of not less than one year, and at the processing plant or other reason ably accessible location for an addi tional two years, all records of proc essing, deviations in processing, con tainer closure inspections, and other records specified in part 113 of this chapter. If during the first year of the three-year record retention period the processing plant is closed for a pro longed period between seasonal packs, VerDate Mar<15>2010 13:44 Apr 26, 2011 Jkt 223066 PO 00000 Frm 00218 Fmt 8010 Sfmt 8010 Y:\SGML\223066.XXX 223066W R e ie r A vi le s o n D S K G B L S 3 C 1 P R O D w ith C F R 209 Food and Drug Administration, HHS § 108.35 the records may be transferred to some other reasonably accessible location at the end of the seasonal pack. Upon written demand during the course of a factory inspection pursuant to section 704 of the act by a duly authorized em ployee of the Food and Drug Adminis tration, a commercial processor shall permit the inspection and copying by such employee of these records to verify the adequacy of processing, the integrity of container closures, and the coding of the products. (i) This section shall not apply to the commercial processing of any food processed under the continuous inspec tion of the meat and poultry inspection program of the Animal and Plant Health Inspection Service of the De partment of Agriculture under the Fed eral Meat Inspection Act (34 Stat. 1256, as amended by 81 Stat. 584 (21 U.S.C. 601 et seq.)) and the Poultry Products Inspection Act (71 Stat. 441, as amend ed by 82 Stat. 791 (21 U.S.C. 451 et seq.)). (j) Compliance with State regula tions: (1) Wherever the Commissioner finds that any State regulates the com mercial thermal processing of low-acid foods in accordance with effective reg ulations specifying at least the require ments of part 113 of this chapter, he shall issue a notice stating that com pliance with such State regulations shall constitute compliance with part 113 of this chapter. However, the provi sions of this section shall remain appli cable to the commercial processing of low-acid foods in any such State, ex cept that, either the State through its regulatory agency or each processor of low-acid foods in such State shall file with the Center for Food Safety and Applied Nutrition the registration in formation and the processing informa tion prescribed in paragraph (c) of this section. (2) The Commissioner finds that the regulations adopted by the State of California under the laws relating to cannery inspections governing thermal processing of low-acid foods packaged in hermetically sealed containers sat isfy the requirements of part 113 of this chapter. Accordingly, processors, who under the laws relating to cannery inspections are licensed by the State of California and who comply with such state regu lations, shall be deemed to comply with the requirements of part 113 of this chapter. (k) Imports: (1) This section shall apply to any foreign commercial proc essor engaged in the thermal proc essing of low-acid foods packaged in hermetically sealed containers and of fering such foods for import into the United States except that, in lieu of providing for the issuance of an emer gency permit under paragraph (a) of this section, the Commissioner will re quest the Secretary of the Treasury to refuse admission into the United States, pursuant to section 801 of the act, of any such low-acid foods which the Commissioner determines, after in vestigation, may result in the distribu tion in interstate commerce of proc essed foods that may be injurious to health as set forth in paragraph (a) of this section. (2) Any such food refused admission shall not be admitted until such time as the Commissioner may determine that the commercial processor offering the food for import is in compliance with the requirements and conditions of this section and that such food is not injurious to health. For the purpose of making such determination, the Com missioner reserves the right for a duly authorized employee of the Food and Drug Administration to inspect the commercial processor’s manufacturing, processing, and packing facilities. (l) The following data and informa tion submitted to the Food and Drug Administration pursuant to this sec tion are not available for public disclo sure unless they have been previously disclosed to the public as defined in § 20.81 of this chapter or they relate to a product or ingredient that has been abandoned and they no longer rep resent a trade secret or confidential commercial or financial information as defined in § 20.81 of this chapter: (1) Manufacturing methods or proc esses, including quality control infor mation. (2) Production, sales, distribution, and similar data and information, ex cept that any compilation of such data and information aggregated and pre pared in a way that does not reveal data or information which is not avail able for public disclosure under this VerDate Mar<15>2010 13:44 Apr 26, 2011 Jkt 223066 PO 00000 Frm 00219 Fmt 8010 Sfmt 8010 Y:\SGML\223066.XXX 223066W R e ie r A vi le s o n D S K G B L S 3 C 1 P R O D w ith C F R 210 21 CFR Ch. I (4–1–11 Edition) Pt. 109 provision is available for public disclo sure. (3) Quantitative or semiquantitative formulas. [42 FR 14334, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977; 54 FR 24891, June 12, 1989; 61 FR 14480, Apr. 2, 1996; 66 FR 56035, Nov. 6, 2001] PART 109—UNAVOIDABLE CON TAMINANTS IN FOOD FOR HUMAN CONSUMPTION AND FOOD-PACKAGING MATERIAL Subpart A—General Provisions Sec. 109.3 Definitions and interpretations. 109.4 Establishment of tolerances, regu latory limits, and action levels. 109.6 Added poisonous or deleterious sub stances. 109.7 Unavoidability. 109.15 Use of polychlorinated biphenyls (PCB’s) in establishments manufacturing food-packaging materials. 109.16 Ornamental and decorative ceramicware. Subpart B—Tolerances for Unavoidable Poisonous or Deleterious Substances 109.30 Tolerances for polychlorinated biphenyls (PCB’s). Subpart C—Regulatory Limits for Added Poisonous or Deleterious Substances [Reserved] Subpart D—Naturally Occurring Poisonous or Deleterious Substances [Reserved] AUTHORITY: 21 U.S.C. 321, 336, 342, 346, 346a, 348, 371. SOURCE: 42 FR 52819, Sept. 30, 1977, unless otherwise noted. Subpart A—General Provisions § 109.3 Definitions and interpretations. (a) Act means the Federal Food, Drug, and Cosmetic Act. (b) The definitions of terms con tained in section 201 of the act are ap plicable to such terms when used in this part unless modified in this sec tion. (c) A naturally occurring poisonous or deleterious substance is a poisonous or deleterious substance that is an inher ent natural constituent of a food and is not the result of environmental, agri cultural, industrial, or other contami nation. (d) An added poisonous or deleterious substance is a poisonous or deleterious substance that is not a naturally oc curring poisonous or deleterious sub stance. When a naturally occurring poisonous or deleterious substance is increased to abnormal levels through mishandling or other intervening acts, it is an added poisonous or deleterious substance to the extent of such in crease. (e) Food includes human food and substances migrating to food from food-contact articles. § 109.4 Establishment of tolerances, regulatory limits, and action levels. (a) When appropriate under the cri teria of § 109.6, a tolerance for an added poisonous or deleterious substance, which may be a food additive, may be established by regulation in subpart B of this part under the provisions of sec tion 406 of the act. A tolerance may prohibit any detectable amount of the substance in food. (b) When appropriate under the cri teria of § 109.6, and under section 402(a)(1) of the act, a regulatory limit for an added poisonous or deleterious substance, which may be a food addi tive, may be established by regulation in subpart C of this part under the pro visions of sections 402(a)(1) and 701(a) of the act. A regulatory limit may pro hibit any detectable amount of the sub stance in food. The regulatory limit es tablished represents the level at which food is adulterated within the meaning of section 402(a)(1) of the act. (c)(1) When appropriate under the cri teria of § 109.6, an action level for an added poisonous or deleterious sub stance, which may be a food additive, may be established to define a level of contamination at which a food may be regarded as adulterated. (2) Whenever an action level is estab lished or changed, a notice shall be published in the FEDERAL REGISTER as soon as practicable thereafter. The no tice shall call attention to the mate rial supporting the action level which shall be on file with the Division of Dockets Management before the notice VerDate Mar<15>2010 13:44 Apr 26, 2011 Jkt 223066 PO 00000 Frm 00220 Fmt 8010 Sfmt 8010 Y:\SGML\223066.XXX 223066W R e ie r A vi le s o n D S K G B L S 3 C 1 P R O D w ith C F R