
[Federal Register Volume 79, Number 223 (Wednesday, November 19, 2014)]
[Proposed Rules]
[Pages 68810-68812]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-27290]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 10

[Docket No. FDA-2012-D-1002]


Questions and Answers Regarding Food Facility Registration (Sixth 
Edition); Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a guidance for industry entitled ``Questions and 
Answers Regarding Food Facility Registration (Sixth Edition).'' The 
guidance includes one additional question and answer regarding FDA's 
policy regarding food facility registration for farms that also pack or 
hold raw agricultural commodities grown on a farm under different 
ownership in light of other ongoing FDA Food Safety Modernization Act 
(FSMA) rulemakings.

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

ADDRESSES: 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. Submit written requests for single 
copies of the guidance to the 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 document.

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 ``Questions and Answers Regarding Food Facility Registration 
(Sixth Edition) available on FDA's Web site at http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm331959.htm.'' We are issuing this guidance consistent with our good 
guidance practices (GGP) regulation (Sec.  10.115 (21 CFR 10.115)). In 
accordance with Sec.  10.115(g)(2), we are implementing this guidance 
without prior public comment because we have determined that prior 
public participation is not feasible or appropriate. The guidance 
represents a less burdensome policy consistent with the public health. 
Although this guidance document is immediately in effect, FDA will 
accept comments at any time.
    Section 102 of FSMA (Pub. L. 111-353), signed into law on January 
4, 2011, amends section 415 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 350d) (the FD&C Act) regarding requirements for food 
facility registration. Further, section 102(a)(3) of FSMA amends 
section 415 of the FD&C Act to provide that food facilities required to 
register with FDA must renew their registrations with FDA every 2 
years, between October 1 and December 31 of each even-numbered year, by 
submitting registrations renewals to FDA.
    In addition to amending section 415 of the FD&C Act, FSMA also 
amended the FD&C Act such that section 415 functions in connection with 
other food safety provisions. For instance, FSMA added section 418 of 
the FD&C Act (21 U.S.C. 350g), which establishes certain preventive 
control requirements for food facilities that are required to register 
under section 415 of the FD&C Act. In general, section 418(a) of the 
FD&C Act requires the owner, operator, or agent in charge of a 
``facility'' to evaluate the hazards that could affect food 
manufactured, processed, packed, or held by such facility, identify and 
implement preventive controls, monitor the performance of those 
controls, and maintain records of the monitoring. The term ``facility'' 
is defined in section 418(o)(2) of the FD&C Act as ``a domestic 
facility or a foreign facility that is required to register under 
section 415.''
    As part of the rulemaking to implement section 418 of the FD&C Act, 
on September 29, 2014 (79 FR 58524), we published a supplemental notice 
of proposed rulemaking in the Federal Register, ``Current Good 
Manufacturing Practice and Hazard Analysis and Risk-Based Preventive 
Controls for Human Food'' (preventive controls for human food). In that 
supplemental proposed rule, we proposed, inter alia, certain changes to 
the definition of the term ``farm'' in 21 CFR 1.227 (Sec.  1.227). If 
implemented, these changes would impact food facility registration 
because the food facility registration requirements of section 415 of 
the FD&C Act do not apply to an establishment that meets the definition 
of ``farm.'' The current definition of a ``farm'' under Sec.  1.227 
describes a farm in relevant part as a facility devoted to the growing 
and harvesting of crops, the raising of animals (including seafood), or 
both. Although that definition of ``farm'' then provides that farms 
also pack or hold food, it limits facilities that fall within the 
definition of ``farm'' to those that pack or hold food grown, raised, 
or consumed on that farm or another farm under the same ownership. 
Thus, under the current definition, an establishment that is devoted to 
the growing and harvesting of crops, but also packs and holds food not 
grown or raised on that farm or on another farm under the same 
ownership, would fall outside the definition of ``farm'' and be 
required to register as a food facility. In the supplemental notice of 
proposed rulemaking for preventive controls for human food, FDA 
proposed to revise the ``farm'' definition in relevant part so that it 
would no longer limit establishments that fall within the ``farm'' 
definition to those that pack or hold food grown, raised, or consumed 
on that farm or another farm under the same ownership. Under the 
revised ``farm'' definition, an establishment devoted to the growing of 
crops, the raising of animals, or both, would remain within the 
``farm'' definition (and, thus, not be subject to the FD&C Act section 
415 registration regulations) even if it packs and holds raw 
agricultural commodities grown on another farm.
    In light of this ongoing rulemaking, we are announcing our policy 
regarding food facility registration for farms that also pack or hold 
raw agricultural commodities grown on a farm under different ownership 
and that would no longer be required to register if the proposed 
amendments to the ``farm'' definition are finalized as proposed. Under 
this policy, as discussed in the guidance, FDA does not intend to 
prioritize enforcing the registration requirement for such 
establishments. This policy is a less burdensome policy consistent with 
the public health. FDA intends to make further updates to this guidance 
once certain FSMA rulemakings are final in order to make sure questions 
and answers, key terms, and definitions are consistent and accurate 
with regard to the registration of food facility requirements.
    The guidance represents our 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. An alternative approach may be used 
if such approach satisfies the requirements of the applicable statutes 
and regulations.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations and section 415 of the FD&C Act. 
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 and section 415 of the FD&C Act have been approved 
under OMB control number 0910-0502.

III. Comments

    Interested persons may submit either electronic comments regarding 
this guidance to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the

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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 document at 
either http://www.fda.gov/RegulatoryInformation/Guidances/default.htm 
or http://www.regulations.gov. Always access an FDA guidance document 
by using FDA's Web site listed in the previous sentence to find the 
most current version of the guidance.

    Dated: November 13, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-27290 Filed 11-18-14; 8:45 am]
BILLING CODE 4164-01-P


