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Guidance Issuing OfficeCenter for Food Safety and Applied Nutrition
Because of Congress’s explicit statutory authorization to effectuate certain binding requirements related to food product categories in food facility registrations based on findings in guidance, this document is not subject to the usual restrictions in FDA’s good guidance practice (GGP) regulations, such as the requirements that guidances not establish legally enforceable responsibilities and that they prominently display a statement of the document's nonbinding effect. See 21 CFR 10.115(d) and (i). This guidance contains findings that serve as the predicates for binding requirements on industry.
This guidance represents the Food and Drug Administration’s (FDA’s) conclusion on the necessity of food product categories in food facility registrations submitted to FDA under section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 350d), as added by section 305 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act) and amended by section 102 of the FDA Food Safety Modernization Act (FSMA) (Public Law 111-353). This guidance also updates the food product categories in food facility registrations.
Section 415(a)(2) of the FD&C Act provides, in relevant part, that a food facility must submit to FDA a registration containing information about the general food category (as identified in 21 CFR 170.3 or any other food categories as determined appropriate by FDA, including “by guidance”) of a food manufactured/processed, packed or held at such facility, if the Agency determines “through guidance” that such information is necessary.
To comply with the GGP regulations and make sure that regulated entities and the public understand that guidance documents are nonbinding, FDA guidances ordinarily contain standard language explaining that guidances should be viewed only as recommendations unless specific regulatory or statutory requirements are cited, and FDA’s guidances also ordinarily include the following standard paragraph:
This guidance represents the current thinking of the Food and Drug Administration (FDA or we) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page.
FDA is not including this standard language in this guidance because it is not an accurate description of the effect of this guidance. This guidance contains findings that serve as the predicates for binding requirements on industry. As provided in section 305 of the Bioterrorism Act, this guidance contains FDA’s finding that inclusion of food product categories in food facility registrations is necessary for a quick, accurate, and focused response to an actual or potential bioterrorist incident or other food-related emergency. Based in part on this finding, FDA’s regulations for the registration of food facilities in 21 CFR Part 1, Subpart H require that a food facility submit a registration to FDA containing information on applicable food product categories manufactured/processed, packed, or held at such facility. As provided in section 102 of FSMA, this guidance contains FDA’s finding that inclusion of food product categories other than just those identified in 21 CFR 170.3 is also necessary to facilitate such rapid communications. In addition, this guidance sets forth the other food product categories to be included in food facility registrations as determined to be appropriate by FDA, as provided by section 102 of FSMA.
To the extent that this guidance modifies food product categories for food facility registration pursuant to section 415 of the FD&C Act, it has a binding effect. For these reasons, FDA is not including the standard guidance paragraph in this guidance.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2012-D-0585.