Necessity of the Use of Food Product 
Categories in Food Facility Registrations 
and Updates to Food Product Categories 
(2016 Edition): Guidance for Industry 
Additional copies are available from:  
Office of Compliance 
Division of Field Programs and Guidance (HFS 681) 
Center for Food Safety and Applied Nutrition 
Food and Drug Administration  
5001 Campus Drive 
College Park, MD  20740 
(tel) 240 402 1988 
http://www.fda.gov/FoodGuidances 
 
You may submit electronic or written comments regarding this guidance at any time.  Submit 
electronic comments to http://www.regulations.gov.  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.  All comments should be identified with 
the docket number FDA2012D0585. 
U.S. Department of Health and Human Services 
Food and Drug Administration  
Office of Foods and Veterinary Medicine 
Center for Food Safety and Applied Nutrition 
Center for Veterinary Medicine 
September 2016 Table of Contents 
I.  Introduction 
II.  Background 
III.  Discussion 
IV.  Updates to Food Product Categories 
  2  Necessity of the Use of Food Product 
Categories in Food Facility Registrations 
and Updates to Food Product Categories 
1
(2016 Edition): Guidance for Industry  
I.  Introduction 
Because of Congresss explicit statutory authorization to effectuate certain binding 
requirements related to food product categories in food facility registrations based on findings 
in guidance, this document is not subject to the usual restrictions in FDAs 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) and (i).  This guidance contains findings that serve as 
the predicates for binding requirements on industry.   
 
This guidance represents the Food and Drug Administrations (FDAs) conclusion on the 
necessity of food product categories in food facility registrations submitted to FDA under 
section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 350d), 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) (Public Law 111-353).  This guidance also updates the food 
product categories in food facility registrations.    
 
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 
21 CFR 170.3 or any other food categories 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.   
 
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 FDAs guidances also ordinarily include the 
                                                           
1 This 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. 
 
  3  following standard paragraph: 
 
This  guidance  represents  the  current  thinking  of  the  Food  and  Drug 
Administration (FDA or we) on this topic. It does not establish any rights 
for any person and is not binding on FDA or the public. You can use an 
alternative  approach  if  it  satisfies  the  requirements  of  the  applicable 
statutes and regulations. To discuss an alternative approach, contact the 
FDA staff responsible for this guidance as listed on the title page.  
 
FDA is 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 provided in section 305 of the Bioterrorism 
Act, this guidance contains FDAs finding that inclusion of food product 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, 
FDAs regulations for the registration of food facilities in 21 CFR Part 1, Subpart H require that 
a food facility submit a registration to FDA containing information on applicable food product 
categories manufactured/processed, packed, or held at such facility. As provided in section 102 
of FSMA, this guidance contains FDAs finding that inclusion of food product categories other 
than just those identified in 21 CFR 170.3 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 as determined to be appropriate by FDA, as provided by 
section 102 of FSMA.   
 
To the extent that this guidance modifies food product categories for food facility registration 
pursuant to section 415 of the FD&C Act, it has a binding effect.  For these reasons, FDA is not 
including the standard guidance paragraph in this guidance. 
II.  Background 
On October 10, 2003, FDA issued an interim final rule 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 rule 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 
rule for food facility registration, which generally confirmed the interim final rule (70 FR 
57505).  On July 14, 2016, we published a final rule amending the registration regulations that 
confirmed the requirement to submit food product category information (81 FR 45912).  Under 
21 CFR 1.232(a)(7), food facilities must submit the applicable food product categories of any 
food manufactured/processed, packed, or held at the facility as identified on Form FDA 3537.  
 
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 
  4  at such facility.  On July 17, 2003, FDA issued a guidance stating that FDA 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 food-related 
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 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. 
 
On October 24, 2012, we issued the previous edition of this guidance (77 FR 64999), stating that 
the guidance contained FDAs 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, and also identifying the additional food product categories included as mandatory 
fields in food facility registrations.  
 
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, 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.   
III.  Discussion 
Information about a facilitys food product 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 helps FDA conduct 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 product categories, in conjunction with the prior notification requirements 
in 21 CFR Part 1, Subpart I, help FDA verify 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 examine the shipment to verify its 
contents based on the discrepancy between the registration information and prior notice data.  
FDA finds that requiring food product category information as part of a facilitys 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 FDAs finding that the inclusion of food 
  5  product categories in a facilitys registration is necessary (see 68 FR 42415), FDA included 
food product categories as mandatory fields on the food facility registration form (see 68 FR 
58894 at 58924).  As specified in 21 CFR 1.232(a)(7), FDAs food facility registration 
regulations require registrants to indicate food product category information.  
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IV.  Updates to Food Product Categories  
Section 415(a)(2) of the FD&C Act, as amended by section 102 of FSMA, provides in 
relevant part that a registrant must submit a registration to FDA containing certain information 
and when determined necessary by FDA through guidance, 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 the following additional food product categories are necessary and 
appropriate for food facility registration and has included such categories as mandatory fields 
in the food facility registration form: 
Additional Food Product Categories for Foods for Human Consumption: 
  Acidified Food (see 21 CFR 114.3(b)) (Deleted); 
  Baby (Infant and Junior) Food Products Including Infant Formula; 
  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; 
  Fishery/Seafood Product Categories: Fin Fish, Whole or Filet; Other Shellfish; Ready to 
Eat (RTE) Fishery Products; Processed and Other Fishery Products; Molluscan Shellfish* 
  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)) (Deleted); 
  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 
  If none of the human food categories listed in the registration form apply, print the 
applicable food category or categories. 
Additional Food Product Categories for Foods for Animal Consumption: 
                                                           
2 Food product categories for foods for human and animal consumption marked with asterisks are new. In addition, 
we have listed categories that we are deleting by marking them as deleted, and we have noted where we are 
replacing certain categories with new categories. 
  6    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 Protein Products* (Replaces Animal Derived Products); 
  Botanicals and Herbs*; 
  Brewer Products; 
  Chemical Preservatives; 
  Citrus Products; 
  Distillery Products; 
  Direct Fed Microbials*; 
  Enzymes; 
  Fats or Oils; 
  Fermentation Products; 
  Forage Products*; 
  Human food by-products not otherwise listed*; 
  Marine Products; 
  Milk Products; 
  Minerals or Mineral Products; 
  Miscellaneous or Special Purpose Products; 
  Molasses or Molasses Products; 
  Non-protein Nitrogen Products; 
  Peanut Products; 
  Processed Animal Waste Products* (Replaces Recycled Animal Waste Products); 
  Screenings; 
  Technical Additives*; 
  Vitamins or Vitamin Products; 
  Yeast Products; 
  Mixed Feed (e.g., poultry, livestock, equine); 
  Pet Food; 
  Pet Treats or Pet Chews; 
  Pet Nutritional 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). 
To view Form FDA 3537 (OMB No. 0910-0502), please click on the following link at 
https://www.access.fda.gov.  If you would like to request a paper copy of Form FDA 3537 be 
sent to you, please contact the FDA staff responsible for this guidance as listed on the title page. 
  7