scientific 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 Administration. Within 30 days after first use, the packer shall submit to the Food and Drug Administration, Bureau of Foods, 200 C St. SW., HFF-419, Washington, DC 20204 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 intentional 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 filed as a scheduled process, accompanied by full information on the specified forms as provided in this paragraph.

(iii) Many packers employ an 'operating" process in which retort operators are instructed to use retor temperatures and/or processing times slightly in excess of those spec. fed in the scheduled process as a lety factor to compensate for minor actuations in temperature or time to assure that the minimum times and temperatures in the scheduled process are always met. This would not constitute a modification of the scheduled process.

(3) Process adherence and information. (1) A commercial processor engaged in the thermal processing of low-acid foods packaged in hermetically sealed containers in any registered establishment shall process each lowacid 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 com

mercial processor engaged in thermal processing of low-acid foods packaged in hermetically sealed containers shall provide the Food and Drug Administration 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 information by the Food and Drug Administration, and that the information concerning processes and other data so furnished shall be regarded as trade secrets 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 instance 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 entered distribution.

(e) A commercial processor engaged in thermal processing of low-acid foods packaged in hermetically sealed containers shall promptly report to the Food and Drug Administration any instance wherein any lot of such food, which may be injurious to health by reason of contamination with microorganisms, has in whole or in part entered 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 recalls of any product that may be injurious to health; for identifying, collecting, warehousing, and controlling the product; for determining the effectiveness 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 thermal 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 operations, and container closure inspections, 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 and shall not apply until March 25, 1975 in any other State. 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 period of not less than one year, and at the processing plant or other reasonably accessible location for an additional two years, all records of processing, deviations in processing, container 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 prolonged period between seasonal packs, 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 employee of the Food and Drug Administration, 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 inspection of the meat and poultry inspection program of the Animal and Plant Health Inspection Service of the Department of Agriculture under the Federal Meat Inspection Act (34 Stat. 1256, as amended by 81 Stat. 584 (21 US.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.)).

(j) Compliance with State regulations: (1) Wherever the Commissioner finds that any State regulates the commercial thermal processing of lowacid foods in accordance with effective regulations specifying at least the requirements of Part 113 of this chapter, he shall issue a notice stating that compliance with such State regulations shall constitute compliance with Part 113 of this chapter. However, the provisions of this section shall remain applicable to the commercial processing of low-acid foods in any such State, except that, either the State through its regulatory agency or each processor of low-acid foods in such State shall filed with the Bureau of Foods the registration information and the processing information 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 satisfy 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 regulations, 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 processor engaged in the thermal processing of low-acid foods packaged in hermetically sealed containers and offering such foods for import into the United States except that, in lieu of providing for the issuance of an emergency permit under paragraph (a) of this section, the Commissioner will request 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 investigation, may result in the distribution in interstate commerce of processed 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 Commissioner 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.

(1) The following data and information submitted to the Food and Drug Administration pursuant to this section are not available for public disclosure 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 represent a trade secret or confidential commercial or financial information as defined in § 20.81 of this chapter:

(1) Manufacturing methods or processes, including quality control information.

(2) Production, sales, distribution, and similar data and information, except that any compilation of such data and information aggregated and prepared in a way that does not reveal data or information which is not available for public disclosure under this provision is available for public disclo

Sec. 109.7 Unavoidability. 109.8 Exemptions.

109.15 Use of polychlorinated biphenyls (PCB's) in establishments manufacturing food-packaging materials.

Subpart B-Tolerances for Unavoidable
Poisonous or Deleterious Substances.

109.30 Temporary tolerances for polychlorinated biphenyls (PCB's).

Subpart C—Naturally Occurring Poisonous or Deleterious Substances—[Reserved]

AUTHORITY: Secs. 306, 402(a), 406, 408, 409, 701, 52 Stat. 1045-1046 as amended, 1049 as amended, 1055-1056 as amended, 68 Stat. 511-518 as amended, 72 Stat. 1785-1788 as amended (21 U.S.C. 336, 342(a), 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 contained in section 201 of the act are applicable to such terms when used in this part unless modified in this section.

(c) A “naturally occurring poisonous or deleterious substance" is a poisonous or deleterious substance that is an inherent natural constituent of a food and is not the result of environmental, agricultural, industrial, or other contamination.

(d) An "added poisonous or deleterious substance" is a poisonous or deleterious substance that is not a naturally occurring poisonous or deleterious substance. 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 increase.

(e) "Food" includes human food and substances migrating to food from food-contact articles.

§ 109.4 Establishment of regulations.

(a) When appropriate under the criteria 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 section 406 of the act. A tolerance may prohibit any detectable amount of the substance in food.

(b) (1) When appropriate under the criteria of § 109.6, an action level for an added poisonous or deleterious substance, which may be a food additive, may be established to define the level of contamination at which a food will be deemed to be adulterated. An action level may prohibit any detectable amount of the substance in food.

(2) Whenever an action level is established, a notice shall be published in the FEDERAL REGISTER as soon as practicable thereafter. The notice shall call attention to the material supporting the action level which shall be on file with the Hearing Clerk before the notice is published. The notice shall invite public comment on the action level. Regulatory action may be taken at any time after an action level is established, and need not await publication of the notice. An action level may be changed at any time if the protection of the public health so requires. A notice shall be published in the FEDERAL REGISTER as soon as practicable after an action level is changed.

(c) A regulation may be established in Subpart C of this part to identify a food containing a naturally occurring poisonous or deleterious substance which will be deemed to be adulterated under section 402(a)(1) of the act. These regulations do not constitute a complete list of such foods

§ 109.5 Petitions.

The Commissioner of Food and Drugs, either on his own initiative or on behalf of any interested person who has submitted a petition, may issue a proposal to establish, revoke, or amend a regulation under this part. Any such petition shall include an adequate factual basis to support the petition, shall be in the form set forth in § 10.65 of this chapter, and will be published in the FEDERAL REGISTER for comment if it contains reasonable grounds for the proposed regulation.

§ 109.6 Added poisonous or deleterious substances.

(a) Use of an added poisonous or deleterious substance, other than a pesticide chemical, that is also a food additive will be controlled by a regulation issued under section 409 of the act when possible. When such a use cannot be approved under the criteria of section 409 of the act, or when the added poisonous or deleterious substance is not a food additive, a tolerance or action level may be established pursuant to the criteria established in paragraphs (b) and (c) of this section. Residues resulting from the use of an added poisonous or deleterious substance that is also a pesticide chemical will ordinarily be controlled by a tolerance established in a regulation issued under section 406, 408, or 409 by the U.S. Environmental Protection Agency (EPA). When such a regulation has not been issued, an action level for an added poisonous or deleterious substance that is also a pesticide chemical may be established by the Food and Drug Administration. The Food and Drug Administration will request EPA to recommend such an action level pursuant to the criteria established in paragraph (c) of this section.

(b) A tolerance for an added poisonous or deleterious substance in any food may be established when the following criteria are met:

(1) The substance cannot be avoided by good manufacturing practice.

(2) The tolerance established is sufficient for the protection of the public health, taking into account the extent to which the presence of the substance cannot be avoided and the other ways in which the consumer may be affected by the same or related poisonous or deleterious substances.

(3) No technological or other changes are foreseeable in the near future that might affect the appropriateness of the tolerance established. Examples of changes that might affect the appropriateness of the tolerance include anticipated improvements in good manufacturing practice that would change the extent to which use of the substance is unavoidable and anticipated studies expected

to provide significant new toxicological or use data.

(c) An action level for an added poisonous or deleterious substance in any food may be established when the criteria in paragraph (b) of this section are met, except that technological or other changes that might affect the appropriateness of the tolerance are foreseeable in the near future. An action level shall cease to be enforced and shall be revoked when a tolerance for the same substance and use has become effective.

(d) Tolerances will be established under authority appropriate for action levels (sections 306, 402(a), and 701(a) of the act, together with section 408 or 409 if appropriate) as well as under authority appropriate for tolerances (sections 406 and 701 of the act). In the event the effectiveness of a tolerance is stayed pursuant to section 701(e)(2) of the act by the filing of an objection, the order establishing the tolerance shall be deemed to be an order establishing an action level until final action is taken upon such objection.

§ 109.7 Unavoidability.

(a) Tolerances and action levels in this part are established at levels based on the unavoidability of the poisonous or deleterious substance concerned and do not establish a permissible level of contamination where it is avoidable.

(b) Compliance with tolerances and action levels does not excuse failure to observe either the requirement in section 402(a)(4) of the act that food may not be prepared, packed, or held under insanitary conditions or the other requirements in this chapter that food manufacturers must observe current good manufacturing practices. Evidence obtained through factory inspection or otherwise indicating such a violation renders the food unlawful, even though the amounts of poisonous or deleterious substances are lower than the currently established tolerances or action levels. The manufacturer of food must at all times utilize quality control procedures which will reduce contamination to the lowest level currently feasible.

8109.8 Exceptions.

(a) The Commissioner may exempt from regulatory action and permit the marketing of any food that is unlawfully contaminated with a poisonous or deleterious substance if:

(1) He determines (i) based upon all available scientific evidence, that the food is safe for consumption and (ii) that destruction or diversion of the food involved would result in a substantial adverse impact on the national food supply.

(2) Such determination is published as a notice in the FEDERAL REGISTER and public comment shall be invited on the determination. The notice shall call attention to the material supporting the determination, which shall be on file with the Hearing Clerk before the notice is published.

(3) The determination identifies the level of contamination allowed by the exemption, and the food to which it applies, e.g., the specific growing area or other identifying information. The exemption shall not apply to any other food produced in any other area or at any other time. Contaminated food not subject to the exemption will remain subject to regulatory action.

(b) Any person responsible for contamination of the food involved, or shipment of any such food in interstate commerce prior to the issuance of an exemption pursuant to this section, shall remain subject to regulatory action pursuant to sections 302 (injunction proceedings) and 303 (penalties) of the act.

(c) In the case of a poisonous or deleterious substance which is a pesticide chemical, the level of contamination allowed by the exemption shall, upon request of the Food and Drug Administration, be specified by the Environmental Protection Agency pursuant to paragraph (a)(1)(i) of this section and promulgated by the Commissioner. No exemption for a pesticide chemical shall be promulgated without the concurrence of the Environmental Protection Agency.