
[Federal Register Volume 77, Number 206 (Wednesday, October 24, 2012)]
[Notices]
[Pages 64999-65000]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-26239]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0585]


Guidance for Industry: Necessity of the Use of Food Product 
Categories in Food Facility Registrations and Updates to Food Product 
Categories; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a guidance for industry entitled ``Necessity of the Use 
of Food Product Categories in Food Facility Registrations and Updates 
to Food Product Categories.'' FDA has developed this guidance in 
response to amendments made by the FDA Food Safety Modernization Act 
(FSMA) to the Federal Food, Drug, and Cosmetic Act (FD&C Act). This 
guidance contains FDA's determination that information about food 
product categories in food facility registrations is necessary for a 
quick, accurate, and focused response to a food safety related issue or 
incident, an actual or potential bioterrorist incident, or other food-
related emergency. The guidance also identifies the additional food 
product categories included as mandatory fields in food facility 
registrations, as determined appropriate by FDA.

DATES: Submit either electronic or written comments on FDA guidances at 
any time.

ADDRESSES: Submit written requests for single copies of the guidance to 
Office of Compliance, Division of Field Programs and Guidance, Center 
for Food Safety and Applied Nutrition (HFS-615), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send 
two self-addressed adhesive labels to assist that office in processing 
your request. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Amy Barringer, Center for Food Safety 
and Applied Nutrition (HFS-615), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 240-402-1988.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a guidance for industry 
entitled ``Necessity of the Use of Food Product Categories in Food 
Facility Registrations and Updates to Food Product Categories.'' FDA 
has developed this guidance in response to amendments made by section 
102 of FSMA (Pub. L. 111-353) to section 415(a)(2) of the FD&C Act (21 
U.S.C. 350d(a)(2)).
    FSMA, enacted on January 4, 2011, amended the food facility 
registration requirements of section 415 of the FD&C Act. Section 
415(a)(2) of the FD&C Act, as amended by section 102 of FSMA, provides 
in relevant part that, when determined necessary by FDA through 
guidance, a registrant is required to submit a registration to FDA 
containing information necessary to notify FDA of the general food 
category (as identified in Sec.  170.3 (21 CFR 170.3) or any other food 
categories, as determined appropriate by FDA, including by guidance) of 
any food manufactured, processed, packed, or held at such facility. 
This guidance contains FDA's determination that information about food 
product categories as identified in Sec.  170.3 and the other food 
product categories is necessary for a quick, accurate, and focused 
response to a food safety related issue or incident, an actual or 
potential bioterrorist incident, or other food-related emergency. The 
guidance also identifies the additional food product categories 
included as mandatory fields in food facility registrations, as 
determined appropriate by FDA under section 102 of FSMA.
    In the Federal Register of August 15, 2012 (77 FR 48990), we made 
available a draft guidance entitled ``Guidance for Industry: Necessity 
of the Use of Food

[[Page 65000]]

Categories in Food Facility Registrations and Updates to Food 
Categories'' and gave interested parties an opportunity to submit 
comments to us by September 14, 2012, for us to consider before 
beginning work on the final version of the guidance. We received 
several comments on the draft guidance. We reviewed and evaluated these 
comments and have modified the final guidance where appropriate. 
Changes to the guidance include amending a typographical error in the 
fishery/seafood product categories. We also added the word 
``nutritional'' to the pet supplements category in the food for animal 
consumption food product categories to clarify that the category 
applies to ``pet nutritional supplements.'' The guidance announced in 
this notice finalizes the draft guidance dated August 2012.
    As noted previously, 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 Sec.  170.3 or any other food category as determined appropriate by 
FDA, including ``by guidance'') of a food manufactured/processed, 
packed or held at such facility, if we determine ``through guidance'' 
that such information is necessary. Because of Congress's explicit 
statutory authorization in section 415(a)(2) of the FD&C Act to 
effectuate binding requirements based on actions by 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)(i).
    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 our 
guidances also ordinarily include the following standard paragraph:
    ``This guidance represents FDA's current thinking on this topic. It 
does not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. You can use an alternative approach 
if the approach satisfies the requirements of the applicable statutes 
and regulations. If you want to discuss an alternative approach, 
contact the FDA staff responsible for implementing this guidance. If 
you cannot identify the appropriate FDA staff, call the appropriate 
number listed on the title page of this guidance.''
    We are 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 stated in ``Guidance for 
Industry on Necessity of the Use of Food Product Categories in 
Registration of Food Facilities'' (2003), which was issued under 
section 415 of the FD&C Act, as added by section 305 of the Public 
Health Security and Bioterrorism Preparedness and Response Act of 2002 
(Pub. L. 107-188), we found that inclusion of the food categories in 
Sec.  170.3 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 currently require that a food facility submit 
a registration to FDA containing information on applicable food product 
categories as identified in Sec.  170.3 for food manufactured/
processed, packed, or held at such facility. As provided in section 102 
of FSMA, this guidance contains FDA's finding that inclusion of other 
food categories in food facility registrations 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 determined to be appropriate by FDA for the purposes of 
food facility registration. Insofar as this guidance modifies food 
product categories for food facility registration under section 415 of 
the FD&C Act, it has binding effect. For these reasons, we are not 
including the standard guidance paragraph in this guidance.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in Sec. Sec.  1.230 through 1.235 have been 
approved under OMB Control No. 0910-0502.

III. Comments

    Interested persons may submit either written comments regarding 
this document to the Division of Dockets Management (see ADDRESSES) or 
electronic comments to http://www.regulations.gov. It is only necessary 
to send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either http://www.fda.gov/FoodGuidances or http://www.regulations.gov. 
Use the FDA Web site listed in the previous sentence to find the most 
current version of the guidance.

    Dated: October 18, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-26239 Filed 10-23-12; 8:45 am]
BILLING CODE 4160-01-P


