Foreign New Facility Registration New Data Required by FSMA

Draft-Not for Implementation

Guidance for Industry
Necessity of the Use of Food Categories in
Food Facility Registrations and Updates to
Food Categories
Draft Guidance
This guidance is being distributed for comment purposes only.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to
ensure that the agency considers your comment on this draft guidance before it begins work
on the final version of the guidance, submit either electronic or written comments on the draft
guidance within 30 days of publication in the Federal Register of the notice announcing the
availability of the draft guidance. Submit electronic comments 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. All comments should be identified with the docket number listed in
the notice of availability that publishes in the Federal Register.
For questions regarding this draft document contact the Center for Food Safety and Applied
Nutrition (CFSAN) at 240-402-1988 or the Center for Veterinary Medicine (CVM) at 240276-9207.

U.S. Department of Health and Human Services
Food and Drug Administration
Office of Foods
Center for Food Safety and Applied Nutrition
Center for Veterinary Medicine
August 2012

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Table of Contents

I.

Introduction

II. Background
III. Discussion
IV. Other Food Categories

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Guidance for Industry1
Necessity of the Use of Food Categories in Food Facility
Registrations and Updates to Food Categories
I.

Introduction

This draft guidance represents the Food and Drug Administration's (FDA's) conclusion on the
necessity of food categories in food facility registrations submitted to FDA under section 415 of
the Federal Food Drug and Cosmetic Act (FD&C Act), 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). Section
415(a)(2) of the FD&C Act provides in relevant part that a food facility is required to submit to
FDA a registration containing information about the general food category (as identified in 21
CFR 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 the agency
determines “through guidance” that such information is necessary. 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 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 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.
FDA is not including this standard language in this draft 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
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This draft guidance has been prepared by the Office of Compliance, Division of Field Programs and Guidance in
the Center for Food Safety and Applied Nutrition and the Office of Surveillance and Compliance in the Center for
Veterinary Medicine at the U.S. Food and Drug Administration.
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Act, this guidance contains FDA’s finding that inclusion of food 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 currently require
that a food facility submit a registration to FDA containing information on applicable food
product categories as identified in 21 CFR 170.3 for food manufactured/processed, packed, or
held at such facility. As provided in section 102 of FSMA, this draft 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 draft guidance sets forth the other food
categories to be included in food facility registrations as determined to be appropriate by FDA
for the purposes of food facility registration. Insofar as this guidance, when finalized, modifies
food categories for food facility registration pursuant to section 415 of the FD&C Act, it will
have binding effect. For these reasons, FDA is not including the standard guidance paragraph in
this draft guidance.

II.

Background

On October 10, 2003, FDA issued an interim final regulation to implement section 305 of the
Bioterrorism Act, that generally required domestic and foreign facilities that manufacture,
process, pack, or hold food for human or animal consumption in the United States to register
with FDA by December 12, 2003 (See 68 FR 58894). The interim final regulation also required
facilities to submit registrations to FDA containing information regarding applicable food
product categories as identified in 21 CFR 170.3. On October 3, 2005, FDA issued a final
regulation confirming the interim final regulation, as corrected by a technical amendment (69 FR
29428 (May 24, 2004)), and responding to comments (70 FR 57505).
Section 415(a)(2) of the FD&C Act, as added by section 305 of the Bioterrorism Act, provided in
relevant part that, when determined necessary by FDA “through guidance,” a registrant must
submit a registration to FDA containing information necessary to notify FDA of the general food
category (as identified in 21 CFR 170.3) of food manufactured, processed, packed, or held at
such facility. On July 17, 2003, FDA issued a guidance stating that the agency had determined
that the inclusion of food product categories in food facility registrations was necessary for a
quick, accurate, and focused response to an actual or potential bioterrorist incident or other foodrelated emergency (see 68 FR 42415).
FSMA, enacted on January 4, 2011, amended section 415 of the FD&C Act. Section 415(a)(2)
of the FD&C Act, as amended by section 102 of FSMA, now provides in relevant part that, when
determined necessary by FDA “through guidance,” a registrant must submit a registration to
FDA containing information necessary to notify FDA of 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 any food manufactured, processed, packed, or held at such facility.
FDA believes that it is necessary for a food facility to submit to FDA a registration containing
the general food category as identified in 21 CFR 170.3 and any other food categories as
identified below, if applicable, for a quick, accurate, and focused response to a food-safety

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related issue or an actual or potential bioterrorist incident, other food-related emergency, or food
safety incident.

III. Discussion
FDA believes that information about a facility's food categories is a key element to allow for
rapid communications between FDA and facilities directly impacted by actual or potential
bioterrorist attacks, other food-related emergencies, or food safety incidents. Information about
the categories of food a facility handles currently assists FDA in conducting investigations and
surveillance operations in response to food-related emergencies. These categories 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 is able to alert soft drink manufacturers/processors, packers, and holders about
the incident. Additionally, the food categories, in conjunction with the prior notification
requirements in 21 CFR Part 1, Subpart I aids FDA in verifying that imported products are
correctly identified by where and by 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 finds that requiring food product
category information as part of 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.
Based on section 305 of the Bioterrorism Act and FDA’s finding that the inclusion of food
product categories in a facility's registration is necessary (see 68 FR 42415), the agency included
food product categories identified in 21 C.F.R. 170.3 as mandatory fields on the food facility
registration form. Further, FDA’s current food facility registration regulations require registrants
to indicate in their registrations which of the food categories listed in 21 CFR 170.3 apply to the
foods they manufacture/process, pack, or hold.

IV. Other Food Categories
Section 102 of FSMA, provides in relevant part that FDA may, through guidance, determine that
additional food categories, other than those listed in 21 CFR 170.3, are appropriate for the
purposes of food facility registration under section 415 of the FD&C Act. FDA believes that the
following additional food categories are appropriate for food facility registration and will include
such categories as mandatory fields in the food facility registration form when FDA finalizes this
guidance:
Additional Food Categories for Foods for Human Consumption:
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Acidified Food (see 21 CFR 114.3(b));
Cheese and Cheese Product Categories: Soft, Ripened Cheese; Semi-Soft Cheese;
Hard Cheese; Other Cheeses and Cheese Products;
Dietary Supplement Categories: Proteins, Amino Acids, Fats and Lipid Substances;
Animal By-Products and Extracts; Herbals and Botanicals;
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Fisher/Seafood Product Categories: Fin Fish, Whole or Filet; Shellfish; Ready to Eat
(RTE) Fishery Products; Processed and Other Fishery Products;
Fruit and Fruit Products: Fresh Cut Produce; Raw Agricultural Commodities; Other
Fruit and Fruit Products;
Fruit or Vegetable Juice, Pulp or Concentrate Products;
Low Acid Canned Food (LACF) Products (see 21 CFR 113.3(n));
Nuts and Edible Seed Product Categories: Nut and Nut Products; Edible Seed and
Edible Seed Products;
Shell Egg and Egg Product Categories: Chicken Egg and Egg Products; Other Egg
and Egg Products;
Vegetable and Vegetable Product Categories: Fresh Cut Products; Raw Agricultural
Commodities; Other Vegetable and Vegetable Products; and
Baby (Infant and Junior) Food Products Including Infant Formula.

Additional Food Categories for Foods for Animal Consumption 2 :
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Grain or Grain Products (i.e., barley, grain sorghums, maize, oat, rice, rye, wheat,
other grains or grain products);
Oilseed or Oilseed Products (i.e., cottonseed, soybeans, other oilseeds or oilseed
products);
Alfalfa Products or Lespedeza Products;
Amino Acids or Related Products;
Animal-Derived Products;
Brewer Products;
Chemical Preservatives;
Citrus Products;
Distillery Products;
Enzymes;
Fats or Oils;
Fermentation Products;
Marine Products;
Milk Products;
Minerals or Mineral Products;
Miscellaneous or Special Purpose Products;
Molasses or Molasses Products;
Non-protein Nitrogen Products;
Peanut Products;
Recycled Animal Waste Products;
Screenings;
Vitamins or Vitamin Products;
Yeast Products;
Mixed Feed (e.g., poultry, livestock, equine);

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Most of the additional food categories for foods for animal consumption are currently included on the food facility
registration form as optional fields.
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Pet Food;
Pet Treats or Pet Chews;
Pet Supplements (e.g., vitamins, minerals); and
If none of the above food categories apply, print the applicable food category or
categories (that does not or do not appear above).

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