[Federal Register Volume 77, Number 206 (Wednesday, October 24, 2012)]
[Notices]
[Pages 64999-65000]
From the Federal Register Online via the Government Publishing 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