[Federal Register Volume 68, Number 137 (Thursday, July 17, 2003)]
[Notices]
[Pages 42415-42417]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-18087]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 03D-0195]


Guidance for Industry on Necessity of the Use of Food Product 
Categories in Registration of Food Facilities; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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[[Page 42416]]

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Necessity of the Use 
of Food Product Categories in Registration of Food Facilities.'' FDA 
has developed this guidance in response to section 305(a) of the Public 
Health Security and Bioterrorism Preparedness and Response Act of 2002 
(the Bioterrorism Act), which states that FDA may require registrants 
to submit the general food categories of food manufactured, processed, 
packed, or held at the facility, if FDA determines ``through guidance'' 
that such information is necessary. This guidance contains FDA's 
finding that information about food categories is necessary for a 
quick, accurate, and focused response to an actual or potential 
bioterrorist incident or other food-related emergency.

DATES: This guidance is final upon the date of publication. However, 
you may submit written or electronic comments at any time.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Office of Regulations and Policy (HFS-24), Center for Food Safety 
and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch 
Pkwy., College Park, MD 20740. Send one self-addressed adhesive label 
to assist that office in processing your request or include a fax 
number to which the guidance may be sent.
    Submit written comments on the guidance to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments on the 
guidance to http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Melissa S. Scales, Center for Food 
Safety and Applied Nutrition (HFS-24), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2378.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance entitled 
``Necessity of the Use of Food Product Categories in Registration of 
Food Facilities.'' FDA is issuing this guidance as a followup to the 
publication of its proposed regulation to implement the Bioterrorism 
Act's requirement that domestic and foreign facilities that 
manufacture, process, pack, or hold food for human or animal 
consumption in the United States must register with FDA by December 12, 
2003. (See 68 FR 5378, February 3, 2003.) The final rule, which FDA 
plans to publish in the Federal Register by October 10, 2003, will 
implement section 305 of the Bioterrorism Act. Section 305 of the 
Bioterrorism Act requires domestic and foreign facilities to register 
with FDA by December 12, 2003, even in the absence of final 
regulations. Section 305 of the Bioterrorism Act also states that FDA 
may require registrants to submit the general food categories (as 
identified in Sec.  170.3 (21 CFR 170.3)) of food manufactured, 
processed, packed, or held at the facility, if FDA determines through 
guidance that such information is necessary. This guidance contains 
FDA's finding that inclusion of food product categories in a facility's 
registration is necessary for a quick, accurate, and focused response 
to an actual or potential bioterrorist incident or other food-related 
emergency.
    FDA believes that information about a facility's food product 
categories is a key element to allow for rapid communications between 
FDA and facilities directly affected by an actual or potential 
bioterrorist attack or other food-related emergency. Information about 
the categories of food a facility handles will assist FDA in conducting 
investigations and surveillance operations in response to a food-
related emergency. These categories will also enable FDA to quickly 
alert facilities potentially affected by such an incident if FDA 
receives information indicating the type of food affected. For example, 
if FDA receives information indicating that soft drinks could be 
affected by a bioterrorist incident or other food-related emergency, 
FDA would be able to alert soft drink manufacturers/processors,\1\ 
packers, and holders about the incident. Additionally, the food 
categories in conjunction with the prior notification requirements that 
have been proposed for 21 CFR part 1, subpart I (68 FR 5428, February 
3, 2003), would aid FDA in verifying that imported products are 
correctly identified by where and when they were produced. For example, 
if the registration information identifies a facility as producing only 
dairy products and FDA receives a prior notice for a shipment of nuts 
purporting to have been produced at that facility, FDA can inspect the 
shipment for verification based on the discrepancy. FDA, therefore, 
proposed in Sec.  1.232(e) of the proposed rule to include the food 
product categories listed in Sec.  170.3 as a mandatory field on the 
registration form. (See 68 FR 5378 at 5419, February 3, 2003.) Since 
Sec.  170.3 does not list all the categories of food that are 
manufactured/processed, packed, or held for consumption in the United 
States, FDA proposed to include additional food categories as an 
optional field on the registration form.
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    \1\In the proposed rule, FDA noted that the meanings of the 
terms ``manufacture'' and ``process'' overlap and proposed to define 
both activities together as ``manufacturing/processing.'' (See 68 FR 
5378 at 5382, February 3, 2003.)
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    This guidance represents FDA's finding on the need for food product 
category information as part of the registration of food facilities 
under the Bioterrorism Act. Section 305 of the Bioterrorism Act directs 
FDA to require information about the food categories listed in Sec.  
170.3, if the agency determines ``through guidance'' that such 
information is a necessary component of registration. Because of 
Congress's explicit statutory authorization to establish a binding 
requirement based on a finding 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 Sec.  10.115(d) 
and (i) (21 CFR 10.115(d) and (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 the 
agency's guidances also ordinarily include the following standard 
paragraph:
    This guidance represents the Food and Drug Administration'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.
    Although this guidance has no binding effect, it contains a finding 
that serves as the predicate for a binding regulation that would impose 
a new requirement on industry. If the previsions of the proposed rule 
(68 FR 5378) regarding food categories are finalized as proposed, the 
final rule would require registrants to indicate in their registration 
which of the food

[[Page 42417]]

categories listed in Sec.  170.3 they manufacture/process, pack, or 
hold. In that event, facilities would be unable to use an alternative 
approach to including those food categories in registration because no 
alternative approach would satisfy the requirements of the applicable 
statute and regulations. Therefore, FDA is not including the standard 
guidance paragraph in the guidance because it does not apply.
    FDA is issuing this guidance document as a level 1 guidance. 
Consistent with FDA's GGP regulation, the agency will accept comment, 
but is implementing the guidance document immediately in accordance 
with Sec.  10.115(g)(2), because the agency has determined that prior 
public participation is not feasible or appropriate. FDA is under a 
strict statutory deadline in which to complete the final rule 
associated with this guidance. Moreover, the public has already had an 
opportunity to comment on the necessity of food product categories in 
the proposed rule.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(seeADDRESSES) written or electronic comments on the guidance document. 
Submit a single paper copy of electronic comments to http://www.fda.gov/dockets/ecomments or two paper copies of any mailed 
comments, except that individuals may submit one paper copy. Comments 
are to be identified with the docket number found in brackets in the 
heading of this document. The guidance and received comments may be 
seen in the Division of Dockets Management between 9 a.m. and 4 p.m., 
Monday through Friday.

III. Electronic Access

    An electronic version of this guidance is available on the Internet 
at http://www.cfsan.fda.gov/guidance.html.

    Dated: July 7, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-18087 Filed 7-16-03; 8:45 am]
BILLING CODE 4160-01-S