Contains Nonbinding Recommendations  
 
 
FDA  Oversight of Food  Covered  by  
Systems Recognition  Arrangements:   
 
Guidance  for Food  and Drug 
Administration  Staff  
 
 
 
 
 
 
 
 
 
 
 
 
You may submit written or electronic comments  regarding this guidance  at any time.  Submit 
written comments to the Dockets Management  Staff (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Room 1061, Rockville, MD  20852.  Submit electronic  comments to 
http://www.regulations.gov. All comments should be identified with the docket number  FDA-
2019-D-1997 listed in  the notice of availability  that publishes  in the  Federal Register.  
 
For questions regarding this guidance or additional copies, contact  the Office of Regulatory 
Affairs (ORA) Office of Strategic Planning and  Operational Policy (OSPOP) at 
ORAPolicyStaffs@fda.hhs.gov. 
  
 
 
 
U.S. Department of Health  and Human Services   
Food and Drug Administration  
Office of Regulatory Affairs  (ORA)  
Center for  Food Safety and Applied Nutrition  (CFSAN)  
 
June 2022 
 
 
  Contains Nonbinding Recommendations  
 
TABLE OF  CONTENTS  
 
 
I.    INTRODUCTION...................................................... 1   
 
II.     BACKGROUND....................................................... 2   
 
III.    POLICY................................................................. 3    
 
 
 
 
  Contains Nonbinding Recommendations  
 
FDA Oversight of Food  Covered by  
Systems Recognition  Arrangements:  
 
Guidance  for Food and Drug  
Administration  Staff 
 
 
 
  This guidance represents  the current thinking of the  Food and Drug Administration (FDA or 
Agency) 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 
  or Office  responsible for this guidance  as listed on the title page.  
 
 
I.   INTRODUCTION   
 
The  document provides  guidance  related to  the  FDAs  regulatory oversight activities  for  food1  
covered by  a Systems Recognition Arrangement  (SRA)2  between another countrys  food safety 
authority and  FDA.   
 
The contents of this document do not have the force and effect of  law and are not  meant to bind 
the public in any way, unless specifically incorporated into a  contract. This document is intended 
only to provide clarity to the public regarding existing requirements under the law.  FDA 
guidance documents, including this guidance, 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.  
 
II.   BACKGROUND  
 
The FDA Food Safety Modernization Act (FSMA) transformed FDAs approach to food safety.  
Among other things, FSMA  recognizes  the role of the  food safety  regulatory system  in  exporting 
countries  to  assure compliance with  FDA  food safety standards for  a given food.   Systems 
 
1  Existing Systems  Recognition Arrangements  (SRAs)  define  food  for the  purposes  of  each SRA.   Under  the  
existing SRAs,  the  term  food  includes  (1)  any article  used as  food  or  drink  for  humans,  (2)  chewing  gum,  and (3)  
any  article  used for  components  of  any such  article.   However,  the  SRAs  also exclude  certain types  of  food from  the  
scope  of  the  arrangements.   Excluded  items  may vary  with  each SRA.   For  additional  information  on individual  
SRAs,  including  excluded  products,  please reference the specific arrangements  at:  
https://www.fda.gov/food/international-cooperation-food-safety/systems-recognition-food.  
2  For more general  information  about Systems  Recognition,  please see:  https://www.fda.gov/food/international-
cooperation-food-safety/systems-recognition-food.    
1   Contains Nonbinding Recommendations  
 
Recognition  (SR)  is consistent with  FSMA because it  takes a risk-based approach to the  safety of  
imported food.  To the extent  practicable, FDA will leverage the work done by  foreign 
competent authorities to help ensure the safety of  imported foods.  
 
One way FDA is leveraging the efforts of  some foreign competent authorities is  through an SRA, 
which establishes a  regulatory partnership between FDA and the  Agencys regulatory 
counterpart.  SR  takes into account  whether (1) another  countrys food safety system provides a  
similar, though not necessarily identical, system of protections as the U.S. food safety system  
under FDAs jurisdiction;  and (2)  another  countrys  food safety authority  or authorities provide  
similar oversight and monitoring activities  for food produced under  their  jurisdiction  as FDA 
provides.  SR  is based on the conclusion that food safety  systems with similar elements and  
similar levels of oversight lead  to similar food  safety outcomes.    
 
FDA recognizes that  food safety  issues and outbreaks  associated with inadequate food safety 
practices  can arise  in all countries, and SR  accounts  for this reality.  FDAs  SR  assessments,  
therefore, focus not only on the ability of food safety systems  to help prevent  food safety  
problems, but also on the ability of food safety authorities to identify, address, and contain food 
safety issues  and outbreaks  when they do occur, as well as to  learn from past  events and  
strengthen the system over time.  
 
SR is a reciprocal process.  If FDAs  SR  assessment concludes that  the  foreign competent  
authority  operates a comparable regulatory program  that yields  similar food safety outcomes  as 
the FDA food safety  system,  and  the foreign competent authority reaches the same conclusion  
about the U.S. food safety system under FDAs oversight, then FDA and the foreign competent  
authority may enter into a  regulatory partnership that  is memorialized in  an  SRA. Under an SRA,  
FDA intends  to rely on the food safety oversight  of the foreign competent authority,  which  then  
helps  FDA  refine its risk-based decisions about  the scope and frequency  of its oversight  activities  
related to  imported products, including foreign facility inspections, import  field exams, and 
import sampling.   
 
SR  is one tool among many that allows  FDA  to acknowledge and leverage the reliable  food 
safety oversight  of  a foreign competent authority  in risk-based decision-making  regarding 
inspections, verification programs  (e.g.,  importer verification programs  under FDAs  Foreign 
Supplier Verification Programs  (FSVP)  and  seafood and  juice Hazard Analysis and Critical 
Control Point (HACCP)  regulations), import admissibility, and  follow-up when food safety 
incidents occur.  In addition, FDA may rely  on a foreign competent authoritys  implementation  
of science-based food safety regulatory programs  to take regulatory action  based on information 
provided by those authorities, when appropriate.   SR  allows FDA to better leverage and plan its 
oversight  of foods  because it allows  FDA  to  rely  on regulators in other parts of the world that 
provide a similar system of food safety protection.  This is  one tool  that FDA has to ensure that  
consumers have confidence that their food is  safe, whether produced in the United States  or  
elsewhere.   This level of regulatory partnership and leveraging of work requires a  rigorous  
assessment  process to ensure that FDA is justified in recognizing  a foreign food safety system  
and relying on the work of foreign governments  in making regulatory decisions  about food  
imported into the United States.  
 
2  
  Contains Nonbinding Recommendations  
 
III.   POLICY  
 
SR  allows FDA to avoid duplicating certain  food safety-related work in countries with an SRA.  
Accordingly, for food covered by an  SRA  and  imported  from a country  with an  active  SRA,  
FDA intends to  adjust its  regulatory oversight activities  as follows:  
 
A.   In-country  Food Establishment Inspections  
 
1.   In general, FDA does not intend to prioritize foreign food establishment inspections 
in countries  with an SRA.  Therefore, FDAs routine  inspections of  foreign food 
establishments for  food covered by an  SRA  will be  rare, allowing FDA to allocate its  
risk-based  foreign inspection resources  more efficiently and  effectively.   
2.   Nevertheless,  FDA intends to continue to conduct  inspections in countries with SRAs 
in  certain situations, that include, but are not  limited to:  
a.   To inspect  establishments engaged in  manufacturing/processing, packing, or  
holding FDA-regulated  food  not covered by  the  SRA;  
b.   On a for-cause basis,  where appropriate,  to address a public health concern or  
specific food  safety issues;  and   
c.   For  any establishment, in response to  a request by the  foreign competent  
authority.  
 
B.   Automated Screening  and Risk  Targeting  and Review of Imported Food    
 
1.   FDA intends to  adjust its risk-based screening  and  targeting criteria for import entries  
of food covered by an  SRA  to reflect FDAs determination of the comparability of the  
regulatory system covered by an  SRA,  and  to allow for more efficient and effective  
use of FDAs import investigation  and  screening  resources.   Risk-based screening  and  
review  for foods  imported  from a  country with an  SRA,  but that are not covered by 
the SRA,  will  remain unchanged.   
2.   Import  Alert (IA)  and Detention Without Physical Examination (DWPE)   
a.   Existing IAs   
i.   The  existence of an SRA with a foreign competent authority does not  
necessarily  affect whether there appears to be a  violation of FDA  
requirements.  Therefore, food and establishments  subject to DWPE under  
an existing  IA will not be automatically removed  from the IA  when an SRA  
is signed.   
ii.   FDA  will communicate  with the  foreign competent authority  regarding  
information about the  conditions  that gave rise to the appearance of the  
violation, as appropriate.   Establishments and  food  may be removed from  
DWPE when the conditions that gave rise  to the appearance of  the violation  
have been resolved.   
iii.   FDA will  consider  evidence  provided by the  foreign competent authority  
regarding corrective actions taken by the establishment when assessing  
potential removal from an  IA, as appropriate.  
b.   Future IAs  
3  
  Contains Nonbinding Recommendations  
 
i.   As  appropriate,  FDA may  recommend  for  DWPE  an establishment or food  
from a  food safety  system covered by an SRA.  
ii.   FDA  will ensure  prompt notification, when appropriate  (e.g.,  class I  recalls), 
of a food safety concern to  the  foreign competent  authority.   
iii.   When a  foreign competent authority  has evidence that  is relevant to FDAs 
decision about whether it is appropriate  to list  a food or establishment  on  an  
IA, FDA may consider  such evidence, as appropriate.  
 
C.   Examination and Sampling of Imported  Food  
 
1.   Generally, FDA will not prioritize  import samples  and field examinations  of  food  
covered by an  SRA.  This will be  reflected in FDAs annual field work plan.  
However, there are some situations where FDA will prioritize  examination and 
sampling  a shipment of food  from a  country with  an  SRA, including:  
a.   Food that  FDA is targeting for examination and  sampling on a  surveillance 
basis  (e.g., a particular commodity for which FDA is targeting both domestic  
and import samples);   
b.   Food exported from  a country whose food safety system  is covered by  an  
SRA but the specific type of  food  is  not covered by the SRA; and  
c.   On  a for-cause basis for  food  covered by  an  SRA,  where appropriate to 
address  a specific food safety issue  or other potential violations.  
 
D.   Relevance of  Importer Verification Programs  
 
1.   In accordance with  FDAs  risk-based approach to inspections, when verifying an 
importers  compliance with  importer verification  requirements,  FDA  will make risk-
based decisions about which foods  to target. Therefore, in general:  
a.   With respect to imported foods covered by an SRA, FDA does not intend to 
prioritize inspections  of importers for FSVP3  compliance  or compliance with  
juice  and seafood HACCP importer requirements.4   
b.   However, FDA may periodically verify that importers  of food covered by an 
SRA are in compliance with FSVP  and HACCP  importer  requirements.   
c.   In addition, for importers  of food both from countries with SRAs and from 
countries that do not have SRAs, FDA will continue  to prioritize FSVP  and 
 
3  FSVP  refers  to  the  Rule  on  Foreign  Supplier Verification  Programs  (FSVP)  for  Importers  of  Food  for  Humans  
and  Animals  (21  CFR  part  1 subpart  L).   Under  the  FSVP  rule,  importers  are  required to  perform  certain risk-based 
activities  to  verify that  food imported into the  United  States  has  been produced in a  manner  that  meets  applicable  
U.S.  safety standards.  The  FSVP  rule  provides  for  modified  requirements  for  certain foods  from  a  foreign supplier  in 
a country  whose food  safety  system  has  been  recognized  as  comparable or  determined  to  be the  equivalent  of  the 
United States  system  (21  CFR 1.513).   
4  Juice  and  seafood  HACCP  importer  requirements  refers  to  the  requirements  that  apply  to  importers  under  two  
rules:   HACCP  Procedures  for  the  Safe  and  Sanitary  Processing and Importing of  Juice  (21 CFR  part  120)  and 
Procedures  for  the  Safe  and  Sanitary  Processing and Importing of  Fish and  Fishery  Products  (21 CFR  part  123).  
Under  21  CFR  120.14 and  123.12  of  those  regulations,  importers  of  juice,  fish,  and fishery  products  subject  to the  
HACCP  regulation are  generally required to implement  affirmative  steps  to ensure  that  products  being  offered for  
entry into the  United  States  were  processed  under  controls  that  meet  the  requirements  of  the  relevant  HACCP  
regulations,  among  other  requirements.  
4  
  Contains Nonbinding Recommendations  
 
HACCP  inspections  for those  products  imported  from food safety systems that  
FDA has not recognized.  
2.   FDAs inspections of  imported,  non-covered products will remain unchanged.  
 
E.   Regulatory Compliance  Actions  
 
1.   FDA  may  pursue regulatory actions, such as issuing warning letters,  adding 
establishments  or  food to DWPE, and refusing products  offered for import, as 
appropriate.  This applies  to food and establishments regardless of whether they are  
covered by an SRA.  
2.   The  existence  of an SRA  facilitates FDAs ability to consider  information provided 
by the regulatory authorities, as appropriate, when FDA considers regulatory action.  
5