Contains Nonbinding Recommendations  
 


Guidance for FDA Staff 
 
 
Compliance  Policy  Guide  
Sec.  100.250  Food  Facility  Registration    
Human  and  Animal  Food  
 
 
Additional copies are available from: 
 
Office of Policy and Risk Management
  
Office of Regulatory Affairs
  
Office of Global Regulatory Operations and Policy 
 
Food and Drug Administration 

12420 Parklawn Drive 
  
Rockville, MD 20857
  
(Tel) 240-632-6860
  
http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/default.htm   
 
 
 You may submit either  electronic or written comments regarding this  guidance  at any time.   
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. 
 
 
U.S. Department of Health and Human Services
  
Food and Drug Administration
  
Center for  Food Safety and Applied Nutrition 
 
Center for Veterinary  Medicine  

Office of Regulatory Affairs 
 
 
June 2014 
 
  1 
  Contains Nonbinding Recommendations  
 
Table of Contents  
 
 
I.   Introduction  
II.   Background  
III.   Policy  
IV.   Regulatory Action Guidance  
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  Contains Nonbinding Recommendations  
 
Guidance  for  FDA  Staff 
 
 
Compliance  Policy  Guide  

Sec.  100.250  Food  Facility Registration   
 
Human and  Animal  Food 
 
 
This guidance represents  the Food and Drug Administration's (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 telephone number listed on the title page of this  
guidance.  
 
I.  Introduction:  
 
*The purpose of this document is to provide guidance for FDA staff on food facility  registration  
under section 415 of the  Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 350d), 
including the requirement that certain  human and animal  food facilities register with FDA, the  
requirement that registered  facilities biennially  renew their registrations with FDA, and FDAs  
authority to suspend a  food facilitys  registration.  
 
FDAs  guidance documents, including this guidance, do not establish legally  enforceable  
responsibilities.  Instead, guidances describe the Agencys current thinking  on a topic and should 
be viewed only as  recommendations, unless specific regulatory or statutory requirements are 
cited.  The use of the word should in Agency  guidances  means that something is suggested or  
recommended, but not required.   
 
The term food, when used in this document, has the meaning specified in 21 CFR 1.227(b)(4)  
and refers to both food for humans and food for animals. 
 
II.  Background:  
 
Food  Facility  Registration  
 
Section 305 of the Public Health Security and Bioterrorism  Preparedness and Response Act of  
2002 (the Bioterrorism  Act) (Pub. L. 107-188) amended the  FD&C Act by  adding section 415, 
which established requirements for food facilities to register  with FDA.  Under section 415 of the  
FD&C Act (21 U.S.C. 350d), the owner, operator, or agent in charge of  a domestic or foreign 
facility  that manufactures, processes, packs, or holds food for human or  animal consumption in 
the  United States is  required to register the  facility with FDA, unless an exception applies (see 21 
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CFR 1.226 and 1.227).  The term facility is described in section 415(c)(1) of the FD&C Act  
and defined by  regulation in 21 CFR 1.227(b)(2).  Facilities that do not have to register are listed 
in 21 CFR 1.226.  Certain other establishments are not required to register  because they do not  
manufacture, process, pack, or hold food, as defined in 21 CFR 1.227(b)(4).  This definition  
for food excludes food contact substances (including packaging materials), as defined in 
section 409(h)(6) of the  FD&C Act (21 U.S.C. 348(h)(6)), and pesticides  as defined in 7 U.S.C. 
136(u).  Thus, facilities that manufacture, process, pack, or hold only food contact substances or  
only pesticides  are not required to register with FDA under section 415 of  the FD&C Act.  
 
A domestic facility means any  facility located in any State or Territory of the United States, the  
District of Columbia,  or the Commonwealth of Puerto Rico that manufactures, processes, packs, 
or holds food for consumption in the United States (21 CFR 1.227(b)(2)(i)).  A domestic food 
facility that is required to register must register whether or not food  from that facility  enters  
interstate commerce (21 CFR 1.225(b)).  A foreign facility means a facility other than a domestic  
facility that manufactures, processes, packs, or holds food for consumption in the United States  
(21 CFR 1.227(b)(2)(ii)).  Only facilities - domestic  and foreign - that manufacture, process,  
pack or hold food for consumption in the United States are  required to register with FDA under  
section 415 of the FD&C Act. 
 
Under section 415(a)(2)  of the FD&C Act, the  registrant for a facility must  notify  FDA in a 
timely manner of changes to the facilitys  registration information.  The failure to register  a food  
facility in accordance with section 415 is a prohibited act under section 301(dd) of the  FD&C  
Act (21 U.S.C. 331(dd)).  
 
The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353), enacted on January 4,  
2011, amended section 415 of the FD&C Act in relevant part to require  registrants for food 
facilities to submit additional registration information to FDA, including the email address of the  
contact person for a domestic facility, the email address of the U.S. agent for a foreign facility, 
and an assurance that FDA will be permitted to inspect the facility at the times and in the manner  
permitted by the  FD&C  Act.  FSMA also amended section 415 of the FD&C Act to require food 
facilities to renew  registrations with FDA biennially, and to provide  FDA  with the authority to 
suspend the registration of a food facility in certain circumstances, as discussed further below. 
Further, FSMA amended section 801(l)(1) of the  FD&C Act (21 U.S.C. 381(l)) to provide that if  
an article of food being imported or offered for import into the United States is from a foreign 
facility  for which a registration has not been submitted to FDA, as required by section 415 of the  
FD&C Act, or is from  a foreign facility for  which a registration has been suspended under  
section 415, the article must be held at the port of  entry  for the  article, and may not be delivered 
to the importer, owner, or consignee of the article, until the foreign facility  is registered.  Unlike  
the requirements related to a drug or device establishment, which provide that the failure of such 
an establishment to register with FDA, as required under section 510 of the  FD&C Act (21 
U.S.C. 360), causes the drugs or devices  manufactured, prepared, propagated, compounded, or  
processed in such an establishment to be misbranded under section 502(o) of the FD&C Act  (21  
U.S.C. 352(o)), and therefore subject such misbranded drugs and devices to refusal of  admission 
under section 801(a) of the FD&C Act, the  failure of  a food facility to register with FDA, or the  
suspension of a food facilitys registration, alone  does not cause  food manufactured, processed, 
packed, or held in such facility to be misbranded under the  FD&C Act.  
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However, the failure of a food facility to register  with FDA is a prohibited act under section 
301(dd) of the  FD&C Act (21 USC 331(dd)).  In addition, as discussed elsewhere in this  CPG, 
under section 415(b)(4) of the FD&C Act, if the  registration of a  food facility  is suspended, no 
person can import or  export, offer to import or  export, or otherwise introduce food from the  
facility into interstate or intrastate commerce in the United States.  The introduction or delivery  
for introduction into interstate commerce of an article of food in violation of section 415 is a  
prohibited act under section 301(d) of the  FD&C Act.  In general, the  commission of a prohibited 
act subjects persons to enforcement actions, which may include injunction or prosecution.  
 
FDA's guidance "What You Need to Know About Registration of  Food Facilities" provides  
information on how to submit registration for a food facility  through FDAs electronic portal  at  
www.access.fda.gov. It also provides information on how to submit paper registration.  
 
Biennial  Registration  Renewal  
 
Section 415(a)(3) of the  FD&C Act, as amended by  FSMA, requires food facilities required to 
register with FDA to renew such registrations  biennially.  Specifically, section 415(a)(3)  requires  
that, during the period beginning on October 1 and ending on December 31  of each  even- 
numbered year, a food facility that has submitted a registration to FDA  must submit to FDA a  
renewal registration that  contains the required information specified in section 415(a)(2).  A  
registrant that has not had any  changes to the previously submitted registration information may 
use an abbreviated registration renewal process provided by  FDA.  A  food facility that fails to 
renew its registration with FDA, as  required by section 415(a)(3), has failed to register in 
accordance with section  415 and thereby has committed a prohibited act under section 301(dd)  of 
the FD&C Act.    
 
Suspension  of  Registration  
 
Section 415(b) of the  FD&C Act, as  amended by  FSMA, provides that FDA may suspend the  
registration of a food facility  in certain circumstances.  Specifically, if  FDA determines that food 
manufactured, processed, packed, received, or held by a registered facility  has a reasonable 
probability of causing serious adverse health consequences or death to humans or animals, FDA 
may by order suspend the registration of  a facility that:  
1.	   Created, caused, or  was otherwise responsible  for  such reasonable probability; or  
2.	   Knew of, or had reason to know of, such reasonable probability; and packed, received, or  
held such food.  
 
Under section 415(b)(4)  of the FD&C Act, as amended by  FSMA, if the registration of a human  
or animal food facility is  suspended, no person can import or export, or offer to import or export, 
food from  the facility into the United States, or otherwise introduce food from  the facility into  
interstate or intrastate  commerce in the  United States while the suspension order for the facility  is 
in effect.  Under section 301(d) of the  FD&C Act  (21 U.S.C. 331(d)), the introduction or  
delivery for introduction into interstate commerce of an article of  food in violation of section 415 
is a prohibited act.  Section 801(l) of the  FD&C Act, as amended by FSMA, provides, in relevant  
part, that an article of food being imported or offered for import into the United States that is  
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  Contains Nonbinding Recommendations  
 
from  a foreign facility for which a registration has been suspended under section 415 must be  
held at the port of entry  for the article of food, and may not be delivered to the importer, owner, 
or consignee of the article.  
 
III.  Policy:  
 
Food  Facility  Registration  
 
FDA will enforce the registration requirements of  section 415 of the FD&C Act and 
implementing regulations in 21 CFR part 1, subpart H as appropriate in each situation.  The  
failure to register a food facility in accordance with section 415 is a prohibited act under section 
301(dd) of the  FD&C Act. FDA may  consider a facility to not be registered in accordance with  
section 415 if:  
1.   The facility has not submitted a registration to FDA;  
2.   The facilitys registration is incomplete; or  
3.   The facilitys registration has expired because the facility  failed to renew its registration.  
 
FDAs prior notice for imported foods system  is the agencys primary tool for ensuring that  
foreign facilities that offer food for import into the United States are registered under section 415 
of the FD&C Act.  (See  21 CFR 1.285 and CPG Sec. 110.310 Prior Notice of  Imported Food 
Under the Public Health Security  and Bioterrorism  Preparedness Response Act of 2002).   If FDA  
determines that a  foreign food facility is not registered in accordance with section 415 and 21 
CFR part 1, subpart H,  the food being imported or offered for import into the United States  from  
the foreign facility  is subject to being held  at the port of entry (as defined in 19 CFR 101.1), in 
accordance with section 801(l) of the  FD&C Act, unless U.S. Customs Border Protection (CBP) 
concurrence is obtained for the export of the food and the food is immediately  exported from  the 
port of arrival (as defined in 21 CFR 1.276(b)(11)  (see 21 CFR 1.285(b)).  Food held in this  
circumstance shall not be entered and shall not be  delivered to the importer, owner, or  ultimate  
consignee until the foreign facility is registered in accordance with section 415 and 21 CFR part  
1, subpart H, and the  appropriate registration number is provided in prior notice as specified in 
21 CFR 1.285(i).  FDA  may  allow the food held at the port of entry to be  moved to a secure 
facility,  as appropriate (21 CFR 1.285(c)(2)).  However, FDA ordinarily will not allow the food 
to be transferred by  any  person from  the port of entry into the U.S. or from  the secure facility.  
 
Biennial  Registration  Renewal  
 
FDA will consider  a registration for a food facility  to be  expired if the registration is not  
renewed, as required by section 415(a)(3) of the  FD&C Act.  Thus, if  a food facility that  
previously submitted a  registration to FDA does not submit a registration renewal to  FDA during  
the period beginning on October 1 and ending on December 31 of  each even-numbered year,  
FDA will consider the registration  for the facility  to be expired, and will notify the registrant for 
the facility that the facilitys  registration has expired.  FDA  will consider a  food facility with an 
expired registration to have failed to register in accordance with section 415.  As previously  
stated in this document, the failure of a food  facility to renew its registration with FDA, as  
required by section 415(a)(3), means that the facility has failed to register in accordance with  
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  Contains Nonbinding Recommendations  
 
section 415 of the FD&C Act.  Accordingly, the failure to register a food facility in accordance 
with section 415 is a prohibited act under section 301(dd) of the  FD&C Act. 
 
Suspension  of  Registration  
 
Under section 415(b)(4)  of the FD&C Act, if the registration of a food facility is suspended, no 
person can import or export, or offer to import or  export, food from  the facility into the United  
States, or otherwise introduce food from  the facility  into interstate or intrastate commerce in the 
United States while the suspension order for the facility is in effect.  The introduction or delivery  
for introduction into interstate commerce of  an article of food in violation of section 415 is a  
prohibited act under section 301(d) of the  FD&C Act. 
 
If a domestic  facility that is subject to a registration suspension order introduces food from  such 
facility into intrastate or interstate commerce, FDA  may pursue  enforcement action,  such as  
administrative detention, seizure, injunction, mandatory  recall, prosecution, or a combination of  
such actions, as appropriate, provided that the  applicable legal requirements are satisfied.  
 
If FDA determines that a food offered for  entry into the United States is from a  foreign food 
facility with a suspended  registration,  such article shall be held at the port of entry according to 
section 801(l) of the  FD&C Act.  
 
IV.  Regulatory  Action Guidance:  
 
Food  Facility  Registration  
 
The owner, operator, or agent in charge of  a domestic  facility, as defined in 21 CFR  
1.227(b)(2)(i), must register the facility with FDA, unless exempted, as provided in 21 CFR  
1.226, whether or not  food from  the facility enters  interstate commerce.   FDA anticipates that it,  
or a State agency acting  on behalf of  FDA,  may discover a domestic facility's failure to be 
registered during  a routine inspection of the facility.  During  an inspection, the investigator  
should determine whether a facility is registered and whether information in the registration is  
accurate and current.  If the investigator identifies  a registration violation, the investigator should 
advise the facilitys  management of the  requirement to register or the requirement to update  
mandatory elements of the registration.  The investigator  should also provide the management  
with FDAs  guidance, What You Need to Know About Registration of  Food Facilities. The 
investigator should document in the establishment inspection report the information obtained 
regarding the  facilitys registration.  The investigator also should document information provided 
to the management of the unregistered facility regarding the registration requirements of  section  
415 of the FD&C Act.  
 
The Districts have direct reference authority to issue an Untitled  Letter to a domestic food 
facility and the Centers (CFSAN or CVM, as appropriate)  may issue  an Untitled  Letter to a  
foreign  or domestic food facility when the facility  is required to register under section 415 of the  
FD&C Act, the facility has not registered, and the  following conditions apply:  
 	  The facility  manufactures, processes, packs, or holds food for human or  animal  
consumption in the U.S. and the facility is not exempt from  the registration requirement;  
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 	  The establishment  file documents that facility  management has been advised orally or in 
writing that the owner, operator, or  agent in charge  must register  the facility  with FDA; 
and  
 	  The office  issuing the Untitled  Letter  has verified that the facility is not registered.  
 
CFSAN or CVM, as appropriate, should advise the Division of Food Defense Targeting (DFDT), 
formerly known as the Prior Notice Center, when a foreign facility has not  registered with  FDA 
in accordance with section 415 for future shipment targeting.    Articles of  food from  the foreign 
facility  for which a registration has not been submitted to FDA in accordance with section 415 
are subject  to being held at the port of entry pursuant to section 801(l) of the FD&C Act.  
 
Biennial  Registration  Renewal  
 
CFSAN, Office of  Compliance, or CVM, Office Of  Surveillance and Compliance,  or a  District 
Office,  as appropriate,  may notify a  facility that has not submitted a registration renewal  to FDA,  
as required by section 415(a)(3) of the  FD&C Act, of the requirement for biennial registration  
renewal.  The process for  notifying a food  facility that has not submitted a registration renewal to  
FDA of the renewal requirement should be coordinated by the appropriate District Office and  
Center.  
 
Suspension  of  Registration  
 
The District or appropriate Center  may recommend suspension of registration for a human or  
animal food facility based on evidence that food manufactured, processed, packed, received, or  
held by the facility has a reasonable probability of  causing serious adverse health consequences  
or death to humans or  animals and the facility:  
1.	   Created, caused, or  was otherwise responsible  for  such reasonable probability; or  
2.	   Knew of, or had reason to know of, such reasonable probability; and packed, received, or  
held such food.  (See section 415(b) of the  FD&C Act).  
 
Suspension of a food facilitys registration may be considered whenever the criteria for  
suspension in section 415(b) of the  FD&C Act  are met.  Examples of circumstances in which the 
District or Center should  give priority  consideration to recommending suspension of a food 
facilitys registration include, but are not limited to, the following:  
1.	   Inspectional or other evidence (e.g., evidence of  Class 1 recall situation or evidence of  
food associated with foodborne illnesses) indicates that the firm  has significant violations  
of the FD&C Act  and has not permanently corrected the source of the problem. 
2.	   The firm  is subject to a prehearing order to cease  distribution and give notice under  
FDAs  mandatory recall authority, section 423(b)  of the FD&C Act  (21 U.S.C. 350l(b)). 
3.	   The firm  is subject to an emergency permit order  under 21 CFR part 108 or  the District or  
Center is considering  a recommendation to issue an emergency permit  order to the firm. 
4.	   The firm  is a foreign facility  and food from  the firm  is subject to an Import Alert that 
provides for detention without physical examination because the food may  cause serious  
adverse health consequences or death to humans or animals.  
 
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Under section 415(b)(4)  of the FD&C Act, if the registration of a food facility is suspended, no 
person can import or export, or offer to import or  export, food from  the facility into the United  
States, or otherwise introduce food from  the facility  into interstate or intrastate commerce in the 
United States while the suspension order for the facility is in effect.  The introduction or delivery  
for introduction into interstate commerce of  any article of food in violation of section 415 is a  
prohibited act under section 301(d) of the  FD&C Act.  While a registration suspension order is in 
effect for a domestic facility, the District in which the facility is located should take appropriate  
actions to ensure that food from  the facility is not introduced into interstate  or intrastate  
commerce in the United  States.  
 
CFSAN or CVM, as appropriate, should advise the DFDT when a registration suspension order  
is issued to a foreign facility  for future shipment targeting.    While the registration suspension 
order is in effect, articles  of food from the  foreign facility  are subject to being held at the port of  
entry pursuant to section 801(l) of the  FD&C Act.* 
 
*Material between asterisks is new or revised.  
 
Issued: 12/2003 
Revised: 11/2004, 8/2006, 6/2014 
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