Sec. 205. Inspections of food facilities
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The Administrator shall establish an inspection program, which shall include sampling and testing of food and food facilities, to determine if each food facility— is operating in a sanitary manner; has continuous systems, interventions, and processes in place to minimize or eliminate contaminants in food; uses validated process controls and ongoing verification; is in compliance with applicable performance standards established under section 204, process control regulations, and other requirements; is processing food that is safe and not adulterated or misbranded; maintains records of process control plans under section 203, and other records related to the processing, sampling, and handling of food; and is in compliance with the requirements of the applicable food safety law.
Inspections of food facilities under this Act shall be based on the following categories and inspection frequencies, subject to subsections (c), (d), and (e): A category 1 food facility shall be subject to antemortem, postmortem, and continuous inspection of each slaughter line during all operating hours, and other inspection on a daily basis, sufficient to verify that— diseased animals are not offered for slaughter; the food facility has successfully identified and removed from the slaughter line visibly defective or contaminated carcasses, has avoided cross-contamination, and has destroyed or reprocessed contaminated carcasses in a manner acceptable to the Administrator; and applicable performance standards and other provisions of the food safety law, including those intended to eliminate or reduce pathogens, have been satisfied.
A category 2 food facility shall be randomly inspected at least daily. A category 3 food facility shall— provide documentation to the Administrator on request that ongoing verification shows that its processes are controlled; and be randomly inspected at least monthly. A category 4 food facility shall be randomly inspected at least quarterly. A category 5 food facility shall be randomly inspected at least annually. The Administrator shall establish procedures under which inspectors or safety officers inspect food facilities, which shall allow the taking of random samples, photographs, and copies of records in food facilities.
With respect to a category 2, 3, 4, or 5 food facility, to foster a risk-based allocation of resources, the Administrator may establish, in accordance with this subsection, alternative increased or decreased inspection frequencies for— 1 or more subcategories of food facilities under paragraph (2); and 1 or more specific food facilities under paragraph (3). The Administrator shall define, by regulation, each subcategory of food facilities established under paragraph (1)(A) and the alternative inspection frequency of that subcategory.
In defining a subcategory of food facilities and the alternative inspection frequency of that subcategory under subparagraph (A), the Administrator shall consider— the nature of the foods being processed, stored, or transported; the manner in which foods are processed, stored, or transported; the inherent likelihood that the foods will contribute to the risk of foodborne illness; the best available evidence concerning reported illnesses associated with the foods produced in the proposed subcategory of facilities; and the overall record of compliance with the food safety law among facilities in the proposed subcategory, including compliance with applicable performance standards and the frequency of recalls.
The Administrator— may establish an alternative inspection frequency for increased or decreased inspection for a specific food facility; and shall annually publish a list of food facilities subject to alternative inspection frequencies under clause (i). In establishing an alternative inspection frequency for a specific food facility, the Administrator shall consider— the supporting evidence that the specific food facility shall submit to the Administrator relating to whether an alternative inspection frequency should be established for that facility by the Administrator; whether products from the specific food facility have been associated with a case or an outbreak of foodborne illness; the record of the facility of compliance with the food safety law, including compliance with applicable performance standards and the frequency of recalls; and the considerations described in clauses
(i)through
(iii)of paragraph (2)(B). An alternative inspection frequency for a subcategory of food facilities or a specific food facility under this subsection shall be— in the case of a category 2 food facility, not less frequently than monthly; and in the case of a category 3 or 4 food facility, not less frequently than annually. Before issuing a regulation or order establishing a decreased alternative inspection frequency for a subcategory of food facilities or an individual food facility under this subsection, the Administrator shall— describe, in general terms, the alternative uses of resources of the Administration that would have been required to carry out the inspection activity; and determine, based on the best available evidence, that the alternative uses of the resources would make a greater contribution to protecting the public health and reducing the risk of foodborne illness. The Administrator shall manage the transition to the inspection system described in this Act as follows: The Administrator shall promulgate regulations to implement this section no later than 24 months after the date of enactment of this Act. For any food facility, the Administrator shall not reduce the inspection frequency from the frequency required pursuant to the Federal Meat Inspection Act ( 21 U.S.C. 601 et seq.), the Poultry Products Inspection Act ( 21 U.S.C. 451 et seq.), and the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq.) until the food facility has demonstrated that sufficient changes in facilities, procedures, personnel, or other aspects of the process control system have been made such that the Administrator determines that compliance with the food safety law is achieved. Before the completion of the transition process under subsection (e), the Administrator shall by regulation establish an official mark that can be affixed to a food produced in a category 1, 2, or 3 food facility if— the facility is in compliance with the food safety law; and has been inspected in accordance with the inspection frequencies under this section. The Administrator shall promulgate regulations that provide for the removal of the official mark under this subsection if— the Administrator makes a finding that the facility is not in compliance with the food safety law; or the Administrator suspends the registration of the facility. In the case of products manufactured, slaughtered, processed, or held in a category 1, 2, or 3 food facility— products subject to the Federal Meat Inspection Act ( 21 U.S.C. 601 et seq.), the Poultry Products Inspection Act ( 21 U.S.C. 451 et seq.), the Egg Products Inspection Act ( 21 U.S.C. 1031 et seq.), and the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq.) as of the date of enactment of this Act shall remain subject to the requirement under those Acts that they bear the mark of inspection pending completion of the transition process under subsection (e); the Administrator shall publicly certify on a monthly basis that the inspection frequencies required under this section have been achieved; and a product from a facility that has not been inspected in accordance with the required frequencies under this section shall not bear the official mark and shall not be shipped in interstate commerce. In the case of a product manufactured, slaughtered, processed, or held in a category 4 or 5 food facility, the Administrator shall provide by regulation for the voluntary use of the official mark established under paragraph (1), subject to— such minimum inspection frequencies as determined appropriate by the Administrator; compliance with applicable performance standards and other provisions of the food safety law; and such other requirements as the Administrator considers appropriate. A food facility shall— maintain such records as the Administrator requires by regulation, including all records relating to the processing, distributing, receipt, or importation of any food; and permit the Administrator, in addition to any authority of the food safety agencies in effect on the day before the date of enactment of this Act, upon presentation of appropriate credentials and at reasonable times and in a reasonable manner, to have access to and copy all records maintained by or on behalf of such food facility representative in any format (including paper or electronic) and at any location, that are necessary to assist the Administrator to determine whether the food is contaminated or not in compliance with the food safety law. A food facility shall have an affirmative obligation to disclose to the Administrator the results of testing or sampling of food, equipment, or material in contact with food that is positive for any contaminant. The records required by paragraph
(1)shall be maintained for a reasonable period of time, as determined by the Administrator. The records required by paragraph
(1)shall include records describing— the origin, receipt, delivery, sale, movement, holding, and disposition of food or ingredients; the identity and quantity of ingredients used in the food; the processing of the food; the results of laboratory, sanitation, or other tests performed on the food or in the food facility; consumer complaints concerning the food or packaging of the food; the production codes, open date codes, and locations of food production; and other matters reasonably related to whether food is unsafe, is adulterated or misbranded, or otherwise fails to meet the requirements of this Act. The Administrator shall develop and maintain procedures to prevent the unauthorized disclosure of any trade secret or confidential information obtained by the Administrator. The requirement under this subsection does not— limit the authority of the Administrator to inspect or copy records or to require the facility or maintenance of records under this Act; have any legal effect on section 1905 of title 18, United States Code; extend to any food recipe, financial data, pricing data, personnel data, or sales data (other than shipment dates relating to sales); limit the public disclosure of distribution records or other records related to food subject to a voluntary or mandatory recall under section 402; or limit the authority of the Administrator to promulgate regulations to permit the sharing of data with other governmental authorities. Section 22 of the Federal Meat Inspection Act ( 21 U.S.C. 622 ) shall apply under this Act.
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