This document is scheduled to be published in the
Federal Register on 11/27/2015 and available online at 
http://federalregister.gov/a/2015-28160
, 
and on 
FDsys.gov
 
4164 -01-P 
DEPARTMENT OF HEALTH AND HUMAN SERVICES  
Food and Drug Administration  
21 CFR Parts 1, 11, and 16 
[Docket No. FDA -2011-N-0146]  
RIN 0910 -AG66  
Accreditation of Third -Party Certification Bodies to Conduct Food Safety Audits and to Issue 
Certifications  
AGENCY:  Food and Drug Administration, HHS . 
ACTION:  Final rule. 
SUMMARY:  The Food and Drug Administration (FDA or we) is adopting regulations to 
provide for accreditation of t hird-party certification bodies to conduct food safety audits of 
foreign food entities, including registered foreign food facilities, and to issue food and facility 
certifications, under the FDA Food Safety Modernization Act (FSMA).  These certifications w ill 
be required for participation in the voluntary qualified importer program  (VQIP) established 
under the Federal Food, Drug, and Cosmetic Act (FD&C Ac t).  In addition, when the Agency 
has determined that an imported food is subject to certification under  FSMA , the Agency may 
require a certification under this rule as a condition for admitting the food into the United States.   
FDA also expects that these regulations will increase efficiency by reducing the number of 
redundant food safety audits.  
DATES:  Th is rule is effective [ INSERT DATE 60 DAYS AFTER DATE OF PUBLICATION 
IN THE FEDERAL REGISTER ].   2 
FOR FURTHER INFORMATION CONTACT:  Charlotte A. Christin, Office of Foods and 
Veterinary Medicine , Food and Drug Administration, 10903 New Hampshire Ave. , Silver  
Spring , MD 20 993, 301-796-7526 . 
SUPPLEMENTARY INFORMATION:  
Table of Contents  
Executive Summary  
I. Introduction and Background  
A. FDA Food Safety Modernization Act  
B. Purpose of This Rulemaking  
C. The Proposed Rule  
D. Public Comments  
II. Legal Authority  
III. Comments on What Definitions Apply to This Subpart (§ 1.600)  
A. Definitions, Ge nerally  
B. Assessment  
C. Audit  
D. Audit A gent 
E. Consultative A udit 
F. Eligible E ntity 
G. Facility  
H. Facility Certification and Food C ertification  
I. Food  
J. Food Safety A udit 3 
K. Foreign C ooperative  
L. Regulatory A udit 
M. Self-Assessment  
N. Third -Party Auditor  
IV. Comments on Who is Subject to This Subpart (§ 1.601)  
A.  Limiting the Scope of the Rule to Regulatory Audits and Certifications  
B.  Exemption for Alcoholic Bevera ges 
C.  USDA Regulated Products  
V. Comments on Recognition of Accreditation Bodies Under this Subpart  
A. Who is Eligible to Seek Recognition ? (§ 1.610)  
B. What Legal Authority Must an Accreditation Body Have to Qualify for Recognition? 
(§ 1.611)  
C. What Competenc y and Capacity Must  an Accreditation Body Have to Qualify  for 
Recognition? (§ 1.612)  
D. What Protections Against Conflicts of Interest Must an Accreditation Body Have to 
Qualify  for Recognition ? (§ 1.613)  
E. What Quality Assurance Procedures Must an Accreditation Body Have to Qualify for 
Recognition ? (§ 1.614)  
F. What Records Procedures Must an Accreditation Body Have to Qualify  for 
Recognition?  (§ 1.615)  
VI. Comments on Requirements for Accreditation Bodies That Have Been Recognized Under 
this Sub part 4 
A. How Must  a Recognized Accreditation Body Evaluate  Third -Party Certification 
Bodies Seeking Accreditation ? (§ 1.620)  
B. How Must  a Recognized Accreditation Body Monitor the Performance  of Third-Party 
Certification Bodies  it Accredited? (§ 1.621)  
C. How Must  a Recognized Accreditation Body Monitor its Own Performance ? 
(§ 1.622)  
D. What Reports  and Notifications Must a Recognized Accreditation Body Submit to 
FDA? (§ 1.623)  
E. How Must  a Recognized Accreditation Body Protect Against Conflicts of Interes t? 
(§ 1.624)  
F. What Records Requirements Must an Accreditation Body  That Has Been Recognized  
Meet ? (§ 1.625)  
VII. Comments on Procedures for Recognition of Accreditation Bodies Under this Subpart  
A. How Do I Apply to FDA for Recognition  or Renewa l of Recognition ? (§ 1.630)  
B. How Will FDA Review my Application for Recognition  or for Renewal  of 
Recognition  and What Happens Once FDA Decides on my Application ? (§ 1.631)  
C. What is the Duration  of Recognition ? (§ 1.632)  
D. How Will FDA Monitor Recognized A ccreditation Bodies ? (§ 1.633)  
E. When Will FDA Revoke Recognition ? (§ 1.634)  
F. What if I Want to Voluntarily Relinquish Recognition or Do Not Want to Renew  
Recognition ? (§ 1.635)  
G. How do I Request Reinstatement of Recognition ? (§ 1.636)  5 
VIII.  Comments on Accreditation of Third -Party Certification Bodies Under this Subpart  
A. Who is Eligible  to Seek Accreditation ? (§ 1.640)  
B. What Legal Authority Must a Third -Party Certification Body Have to Qualify  for 
Accreditation ? (§ 1.641)  
C. What Competency  and Capacity Must a Third -Party Certification Body Have to 
Qualify  for Accreditation ? ( § 1.642)  
D. What Protections Against Conflicts of Interest Must a Third -Party Certification Body 
Have to Qualify  for Accreditation ? (§ 1.643)  
E. What Quality  Assurance Procedures Must a Third -Party Certification Body Have to 
Qualify  for Accreditation ? (§ 1.644)  
F. What Records Procedures Must a Third -Party Certification Body Have to Qualify  for 
Accreditation ? (§ 1.645)  
IX. Comments on  Requirements for Third -Party Certification Bodies That Have Been 
Accredited Under this Subpart  
A. How Must  an Accredited Third -Party Certification Body Ensure Its Audit Agents Are 
Competent and Objective ? (§ 1.650)  
B. How Must  an Accredited Third -Party Ce rtification Body Conduct a Food Safety 
Audit of an Eligible Entity ? (§ 1.651)  
C. What Must  an Accredited Third -Party Certification Body Include in Food Safety 
Audit Reports ? (§ 1.652)  
D. What Must  an Accredited Third -Party Certification Body do When Issuin g Food or 
Facility Certifications ? (§ 1.653)  6 
E. When Must  an Accredited Third -Party  Certification Body Monitor an Eligible Entity 
That it Has Issued a Food or Facility Certification ? (§ 1.654)  
F. How Must an Accredited Third -Party  Certification Body Monitor its Own 
Performance ? (§ 1.655)  
G.  What Reports  and Notifications Must an Accredited Third -Party  Certification Body 
Submit ? (§ 1.656)  
H.  How Must  an Accredited Third -Party Certification Body Protect Against Conflicts of 
Interes t? (§ 1.657)  
I. What Records Requirements Must a Third -Party  Certification Body That Has Been 
Accredited Meet ? (§ 1.658)  
X. Comments on Procedures for Accreditation of Third -Party Certification Bodies Under 
this Subpart  
A. Where Do I Apply  for Accreditatio n or Renewal  of Accreditation  by a Recognized 
Accreditation Body  and What Happens Once the Recognized Accreditation Body 
Decides on My Application ? (§ 1.660)  
B. What is the Duration  of Accreditation  by a Recognized Accreditation Body ? 
(§ 1.661)  
C. How Will FDA Monitor Accredited Third -Party Certification Bodies ? (§ 1.662)  
D. How Do I Request  an FDA Waiver  or Waiver Extension for the 13 -Month Limit for 
Audit  Agents Conducting Regulatory Audits ? (§ 1.663)  
E. When Would FDA Withdraw Accreditation ? (§ 1.664)  
F. What if I Want  to Voluntarily Relinquish Accreditation or Do Not Wan t to Renew 
Accreditation ? (§ 1.665)  7 
G. How do I Request Reaccreditation ? (§ 1.666)  
XI. Comments on Additional Procedures for Direct Accreditation of Third -Party Certification 
Bodies Under  this Subpart  
A. How do I Apply  to FDA for Direct Accreditation or Renewal  of Direct Accreditation ? 
(§1.670)  
B. How Will FDA Review  my Application  for Direct Accreditation or Renewal  of 
Direct Accreditation and What Happens Once FDA Decides on my Application ? 
(§ 1.671)  
C. What is the Duration  of Direct Accreditation ? (§ 1.672)  
XII. Comments on Requirements for Eligible Entities Under this Subpart  
A. How and When Will FDA Monitor Eligible Entities ? (§1.680)  
B. How Frequently Must Eligible Entities be Recertified ? (§1.681)  
XIII.  Comments on General Requirements of this Subpart  
A. How Will FDA Make Information About Recognized Accreditation Bodies and 
Accredited Third -Party Certification Bodies Available to the Public ? (§ 1.690)  
B. How Do I Request Rec onsideration of a Denial  by FDA of an Application  or a 
Waiver Request ? (§ 1.691)  
C.  How Do I Request Internal Agency Review of a Denial  of an Application  or Waiver 
Request Upon Reconsideration ? (§1.692)  
D. How Do I Request a Regulatory Hearing on a Revocation  of Recognition  or 
Withdrawal  of Accreditation ? (§1.693)  
E. Are Electronic Records Created Under This Subpart Subject  to the Electronic 
Records Requirements  of Part 11? (§ 1.694)  8 
F. Are the Records Obtained  by FDA Under this Subpart Subject to Public Disclosure ? 
(§ 1.695)  
G. May Importers Use Reports of Regulatory Audits by Accredited Certification Bodies 
for Purposes of Subpart L of This Part? (§ 1.698)  
XIV.  Editorial and Conforming Changes  
XV. Executive Order 13175  
XVI.  Analysis of Economic Impact  
XVII.  Paperwork Reduction Act of 1995  
XVIII.  Analysis of Environmental Impact  
XIX.  Federalism  
XX. References  
Executive Summary  
Purpose and Coverage of the Final Rule  
This rule is part of FDA’s implementation of FSMA, which intends to better protect 
public health by, among other things, adopting a modern, preventive, and risk -based approach to 
food safety regulation.  In this document, we establish a program for accreditation of third -party 
certification bodies1 to conduct food safety audits and issue  certifications of foreign food 
facilities and foods for humans and animals  for purposes of sections 801(q) and 806 of the 
FD&C Act . We are also codifying certain limited exemptions  to mandatory import certification 
under 801(q) of the FD&C Act  (21 U.S.C. 381). 
                                                 
1 As explained more fully in Response 1, i n response to comments and for clarity, this final rule  uses the term “third -
party certification body”  rather than either the term “third -party auditor”  or the term, “third party 
auditor/certification body” ( except that we will use the term “third -party auditor” in the definitio ns of “accredited 
third -party certification body” and “third -party certification body” in 21 CFR 1.600(c) and in the preamble 
discussion of those definitions in section III.A ).  9 
FSMA added section 808 to the FD&C Act (21 U.S.C. 384d), which directs FDA to 
establish a new program for accreditation of third -party certification bodies to conduct food 
safety audits and to certify that eligible foreign entities (including registered foreign food 
facilities) and food produced by such entities meet applicable FDA requirements  for purposes of  
sections 801(q) and 806 of the FD&C Act .  This rulemaking implements section 808 of the 
FD&C Act; w e will recognize accreditation bodies to accredit third -party certification bodies, 
except for limited circumstances in which we may directly accredit third -party certification 
bodies.  
FSMA specifies two uses for the food and facility certifications issue d by accredited 
third -party certification bodies under this program.  First, facility certifications will be used by 
importers to establish eligibility for VQIP under section 806 of the FD&C Act (21 U.S.C. 
384b(a)).  VQIP offers participating importers exp edited review and entry of food that is part of 
VQIP.  One condition of participation is importation of food from facilities audited and certified 
by third -party certification bodies accredited under this subpart.  FDA issued draft guidance on 
VQIP on June  5, 2015 (80 FR 32136); the draft guidance may be accessed at 
http://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInfor
mation/UCM448558.pdf . 
Second, section 801(q) of the FD&C Act gives FDA the authority to make a risk -based 
determination to require, as a condition of admissibility, that a food imported or offered for 
import into the United States be accompanied by a certification or other assurance that the food 
meets the applicable requirements of the FD&C Act.  The authority t o mandate import 
certification for food, based on risk, is one of the tools we can use to help prevent potentially 
harmful food from reaching U.S. consumers.  When FDA has determined that a food import is 10 
subject to such certification under section 801(q)  of the FD&C Act , FDA will require, as a 
condition of entry, a certification issued either by an accredited third -party certification body 
under this rule or by an agency or representative of the government of the country from which 
the food at issue orig inated, as designated by FDA.   
In addition, facilities and importers may choose to use onsite audits conducted by third -
party certification bodies accredited under the program set out in this rule in connection  with 
meeting  supplier verification requirement s under FDA’s final rules for Current Good 
Manufacturing Practice and Hazard Analysis and Risk -Based Preventive Controls for Human 
Food (final human preventive controls regulation) (80 FR55907, September 17, 2015); Current 
Good Manufacturing Practice and H azard Analysis and Risk -Based Preventive Controls for Food 
for Animals ( final animal preventive controls regulation) (80 FR 56169, September 17, 2015); 
and the Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and 
Animals (published elsewhere in this edition of the Federal Register) (implementing sectio ns 418 
and 805 of the FD&C Act , respectively) .  Under those rules, in circumstances where an onsite 
audit is the appropriate supplier verification activity, such audit must be conducted by a 
“qualified auditor.”   The defin itions of “qualified auditor”  in those rules ma ke clear that an 
example of a potential qualified auditor includes, but is not limited to, an audit agent of  a 
certification body that has been accredited  in accordance with regulations in part 1, subpart M of 
this chapter (i.e., this rule imp lement ing section 808  of the FD&C Act ).   
Summary of Major Provisions of the Final Rule  
This rule establishes the framework, procedures, and requirements for accreditation 
bodies and third -party certification bodies for purposes of section 808  of the FD&C Act.  The 
rule sets requirements for the legal authority, competency, capacity, conflict of interest 11 
safeguards , quality assurance, and records procedures that accreditation bodies must demonstrate 
to be eligible for recognition.  Accreditation bodies also  must demonstrate capability to meet the 
FDA requirements that would apply upon recognition.  Additionally, the rule establishes 
requirements for the legal authority, competency, capacity, conflict of interest safeguards,  quality 
assurance, and records pro cedures that third -party certification bodies must demonstrate to be 
eligible for accreditation.  Third -party certification bodies also must demonstrate capability to 
meet the applicable requirements of the rule that would apply upon accreditation.  
Pursua nt to FSMA section 307 (21 U.S.C. 384d), the rule requires accredited third -party 
certification bodies to perform unannounced facility audits, to notify FDA upon discovering a 
condition that could cause or contribute to a serious risk to the public health,  and to submit to 
FDA reports of regulatory audits conducted for certification purposes.  The rule includes 
stringent requirements to prevent conflicts of interest from influencing the decisions of 
recognized accreditation bodies and accredited third -party  certification bodies.  The rule does 
not, however, establish the audit criteria that accredited third -party certification bodies will use 
in examining eligible entities for compliance with the applicable food safety requirements of the 
FD&C Act and FDA re gulations, because those criteria appear elsewhere in FDA regulations and 
the FD&C Act.  
Costs and Benefits  
Costs of the Third -Party final rule include compliance costs of accreditation bodies and 
certification bodies that choose to participate in our third-party program, and user fees imposed by 
FDA on accreditation bodies and certification bodies for application review and monitoring of 
program participants.  12 
Table  1.--Summary User Fee, Compliance, Undiscounted and Annualized Costs of the Third -Party  (TP) Program Per 
Participant  
Eligible Entity  Audited By  
Total  Certification Bodies 
(CBs)  Currently 
Accredited Under 
Other Programs  CBs Not Accredited 
Under Any Program  
SCENARIO 1        
Number of section  801(q) Entities  10 65 75 
Cost of Compliance with Program 
Requirements ( TP Compliance Cost ) $694  $2,569    
Section  801(q) Compliance Cost  $6,940   $166,985   $173,925   
Number of section  806 Entities  145 971 1,116  
TP Compliance Cost  $694  $2,569   
Section  806 Compliance Cost  $100,630   $2,494,499   $2,595,129   
Total TP Compliance Cost --Scenario 1      $2,769,054  
SCENARIO 2        
Number of section  801(q) Entities  10 65 75 
TP Compliance Cost  $322 $2,197     
Section  801(q) Compliance Cost  $3,220   $142,805   $146,025  
Number of §  806 Entities  459  3,068  3,527  
TP Compliance Cost  $322  $2,197     
Section  806 Compliance Cost  $147,798   $6,740,396  $6,888,194   
Total TP Compliance Cost --Scenario 2      $7,034,219   
SCENARIO 3        
Number of section  801(q) Entities  10 65 75 
TP Compliance Cost  $227  $2,102     
Section  801(q) Compliance Cost  $2,270   $136,630   $138,900   
Number of section  806 Entities  801  5,359  6,160  
TP Compliance Cost  $227  $2,102     
Section  806 Compliance Cost  $181,827   $11,264,618   $11,446,445   
Total TP Compliance Cost --Scenario  3     $11,585,345   
 
The costs that accreditation bodies and certification bodies incur in complying with the 
regulation are necessarily less than the private benefits they accrue by becoming recognized or 
accredited, respectively.  Through the third -party accreditation program more effective 
regulatory oversight is achieved .  FDA  will recoup resources in managing its third -party 
accreditation program  through user fees that FDA intends to impose on participating 
accreditation bodies and third -party certification bodies.    13 
I. Introduction and Background  
A. FDA Food Safety Modernization Act  
FSMA (Pub. L. 111 -353), signed into law by President Obama on January 4, 2011, is 
intended to allow FDA to better protect public health by helping to ensure the safety and security 
of the food supply.  FSMA enables us to focus more on preventing food safety problems rather 
than relying primarily on reacting to problems after they occur.  The law also provides new 
enforcement authorities to help achieve higher rate s of compliance with risk -based, prevention -
oriented safety standards and to better respond to and contain problems when they do occur.  In 
addition, the law contains important new tools to better ensure the safety of imported foods and 
encourages partners hips with State, local, tribal, and territorial authorities  and international 
collaborations with foreign regulatory counterparts .  A top priority for FDA are those FSMA -
required regulations that provide the framework for industry’s implementation of preventive 
controls and enhance our ability to oversee their implementation for both domestic and imported 
food.  To that end, we prop osed the seven foundational rules listed in table 2  and requested 
comments on all asp ects of these proposed rules.   
Table  2.--Published Foundational Proposed Rules for Implementation of FSMA  
Title  Abbreviation  Publication  
Current Good Manufacturing Pract ice and Hazard 
Analysis and Risk -Based Preventive Controls for 
Human Food  2013 proposed human 
preventive controls 
regulation  78 FR 3646, January 16, 
2013  
Standards for the Growing, Harvesting, Packing, 
and Holding of Produce for Human Consumption  2013 proposed produce 
safety regulation  78 FR 3504, January 16, 
2013  
Current Good Manufacturing Practice and Hazard 
Analysis and Risk -Based Preventive Controls for 
Food for Animals  2013 proposed animal 
preventive controls 
regulation  78 FR 64736, October 29, 
2013 
Foreign Supplier Verification Programs (FSVP) 
for Importers of Food for Humans and Animals  2013 proposed FSVP 
regulation  78 FR 45730, July 29, 2013  
Accreditation of Third -Party Auditors/ Certification 
Bodies to Conduct Food Safety Audits and to Issue 
Certifications  2013 proposed third -party  
certification regulation  (also 
referred to in this document 
as the proposed rule)  78 FR 45782, July 29, 2013  
Focused Mitigation Strategies To Protect Food 
Against Intentional Adulteration  2013 proposed intentional 
adulteration regulation  78 FR 78014, December 24, 
2013  14 
Title  Abbreviation  Publication  
Sanitary Transportation of Human and Animal 
Food  2014 proposed sanitary 
transportation regulation  79 FR 7006, February 5, 
2014  
 
We also issued a supplemental notice of proposed rulemaking for the rul es listed in table 
3 and requested comments on specific issues identified in each supplemental notice of proposed 
rulemaking.  
Table  3.--Published Supplemental Notices of Proposed Rulemaking for the Foundational Rules for Implementation 
of FSMA  
Title  Abbreviation  Publication  
Current Good Manufacturing Practice and Hazard 
Analysis and Risk -Based Preventive Controls for 
Human Food  2014 supplemental human 
preventive controls notice  79 FR 58524, September 29, 
2014  
Standards for the Growing, Harvesting, Packing, 
and Holding of Produce for Human Consumption  2014 supplemental produce 
safety notice  79 FR 58434, September 29, 
2014  
Current Good Manufacturing Practice and Hazard 
Analysis and Risk -Based Preventive Controls for 
Food for Animals  2014 supplemental  animal 
preventive controls notice  79 FR 58476, September 29, 
2014  
FSVP for Importers of Food for Humans and 
Animals  2014 supplemental FSVP 
notice  79 FR 58574, September 29, 
2014  
 
We finalized two of the foundational rulemakings listed in table 4 in September 2015.  
 
Table  4.--Published Foundational Final Rules for Implementation of FSMA  
Title  Abbreviation  Publication  
Current Good Manufacturing Practice and Hazard 
Analysis and Risk -Based Preventive Controls for 
Human Food  final human preventive 
controls regulation  80 FR 55908 , September 17, 
2015  
Current Good Manufacturing Practice and Hazard 
Analysis and Risk -Based Preventive Controls for 
Food for Animals  final animal preventive 
controls regulation  80 FR 56170 , September 17, 
2015  
 
As FDA finalizes these seven foundational rulemakings, we are putting in place a 
modern , risk -based  framework for food safety that is based on the most recent science, that 
focuses effort s where the hazards are reasonably likely to occur, and that is flexible and practical 
given our current knowledge of food safety practices.  To achieve this, FDA has engaged in a 
significant amount of outreach to the stakeholder community to find the right  balance between 
flexibility and accountability in these regulations.   
After  FSMA was enacted in 2011, we have been involved in approximately 600 
stakeholder engagements on FSMA and the proposed rules, including public meetings, webinars, 15 
listening sessio ns, farm tours, and extensive presentations and meetings with various stakeholder 
groups (Refs. 1 , 2, 3).  As a result of this stakeholder dialogue, FDA decided to issue the four 
supplemental notices of proposed rulemaking to share our current thinking on key issues and get 
additional stakeholder input on those issues.  As we move forward into the next phase of FSMA 
implementation, we intend to continue this dialogue and collaboration with our stakeholders, 
through guidance, education, training, and assista nce, to ensure that stakeholders  understand and 
engage in their respective roles in food safety.  FDA believes these seven foundational final 
rules, when implemented, will affect  the paradigm shift toward prevention that was envisioned in 
FSMA and be a maj or step forward for food safety that will help protect consumers into the 
future.   
B.  Purpose of This Rulemaking  
FSMA added section 808 to the FD& C Act which directs FDA to establish a new 
voluntary program for accreditation of third -party certification bodies to conduct food safety 
audits and to issue food and facility certifications to eligible foreign entities (including registered 
foreign food f acilities) that meet our applicable requirements  for purposes of sections 801(q) and 
806 of the FD&C Act .  This rulemaking implements section 808 of the FD&C Act; we will 
recognize accreditation bodies to accredit third -party certification bodies, except f or limited 
circumstances in which we may directly accredit third -party certification bodies.  
FSMA specifies  two uses for the food and facility certifications issued by accredited 
third -party certification bodies under this program.  First, facility certif ications will be used by 
importers to establish eligibility for VQIP under section 806 of the FD&C Act.  VQIP offers 
participating importers expedited review and importation for food from facilities audited and 
certified by third -party certification bodies  accredited under this subpart.  FDA issued draft 16 
guidance on VQIP on June 5, 2015 (80 FR 32136); the draft guidance may be accessed at 
http://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInfor
mation/UCM448558.pdf . 
Second, secti on 801(q) of the FD&C Act gives FDA the authority to make a risk -based 
determination to require, as a condition of admissibility, that a food imported or offered for 
import into the United States be accompanied by a certification or other assurance that th e food 
meets the applicable requirements of the FD&C Act.  The authority to mandate import 
certification for food, based on risk, is one of the tools we can use to help prevent potentially 
harmful food from reaching U.S. consumers.  When FDA has determined  that a food import is 
subject to such certification under section 801(q)  of the FD&C Act , FDA will require, as a 
condition of entry, a certification issued either by an accredited third -party certification body 
under this rule or by an agency or represent ative of the government of the country from which 
the food at issue originated, as designated by FDA.   
This final rule will help FDA ensure the competence and independence of third -party 
certification bodies who are accredited to conduct foreign food safe ty audits to examine 
compliance with the applicable food safety requirements of the FD&C Act and FDA regulations, 
among other things.  The document also will help ensure the validity and reliability of 
certifications offered to FDA for purposes of VQIP eli gibility under section 806 of the FD&C 
Act and admissibility of an imported food subject to an FDA risk determination under section 
801(q) of the FD&C Act.   
The third -party certification program is part of FSMA’s paradigm shift toward a modern, 
preventive, and risk-based approach to food safety regulation  and new programs  to facilitate 
global trade in safe food.  Specifically, FSMA requires FDA to issue new preventive controls 17 
and produce safety standards that apply to domestic and foreign proces sors and producers . In 
addition, FSMA directs FDA to issue a n FSVP regulation  requir ing importers to implement 
FSVPs that provide adequate assurances that the ir foreign suppliers produce food that is in 
compliance with processes and procedures, including r isk-based preventive controls, that provide 
the same level of public health protection as those required under section 418 (concerning hazard 
analysis and preventive controls) or 419 (concerning produce safety) of the FD&C Act, as 
appropriate, and that is in compliance with sections 402 (concerning adulteration) and 403(w) 
(concerning misbranding regarding allergen labeling) of the FD&C Act .  We emphasize that 
facilities and importers are not required to use third -party certification bodies accredited under  
this rule in meeting their supplier verification requirements under the final human or animal 
preventive controls or FSVP regulations.   See section XIII.G.  
By contrast, the third -party certification program established un der section 808 of the 
FD&C Act  focuses on food safety audits to certify that eligible foreign entities and the food 
produced by such entities meet applicable FDA requirements for purposes of sections 801(q) and 
806 of the FD&C Act .  Although importers must obtain facility certifications from accredited 
third -party certification bodies under this rule in order to be eligible for VQIP, we note that  
importers seeking to satisfy a requirement  for certification as a condition of admissibili ty for an 
article of food  under section 801(q) of the FD&C Act  may offer a certification issued either by 
foreign government s designated by FDA to issue such certifications or by third -party 
certification bodies accredited under this rule.  
Through FSMA we are transforming our role in the global food safety system, by 
building ever stronger partnerships with our foreign regulatory counterparts and by exploring 
opportunities to leverage private food safety activities to benefit of our system of public food 18 
safety assurances.  We value the role that private audits can play in enhancing food safety when 
done properly, and we share common purpose with the food industry in ensuring the rigor and 
objectivity of those audits.  
The final rule on accreditation of third -party certification bodies reflects the results of 
significant stakeholder engagement to help ensure that the rule achieves its public health goal, 
reflects industry best practice s, and strikes the right balance between flexibility and 
accountability.   
C.  The Proposed Rule  
FDA published a proposed rule for “Accreditation of Third -Party Auditors/Certification 
Bodies to Conduct Food Safety Audits and to Issue Certifications” (the proposed  rule)  on July 
29, 2013.  The proposed rule included eligibility requ irements for accreditation bodies to qualify 
for recognition and requirements that accreditation bodies choosing to participate in the FDA 
program must meet, once recognized.  We also proposed eligibility requirements for third -party 
certification bodies t o qualify for accreditation and requirements that third -party certification 
bodies choosing to participate in the FDA program must meet, once accredited.  We intended the 
proposed requirements to ensure the competenc y and independence of the accreditation bodies 
and third -party certification bodies participating in the program.   
We also proposed procedures for recognition and accreditation, as well as requirements 
relating to monitoring and oversight of participating accreditation bodies and third -party 
certification bodies.  These included procedures that we would follow when removing a  third -
party  certification body or an accreditation body from the program.  Further, w e proposed 
requirements relating to auditing and certification of foreign eligible enti ties under the program, 
and for notifying us of conditions in an audited facility that could cause or contribute to a serious 19 
risk to the public health.  In response to several requests, we extended the proposed rule 
comment period until January 27, 2014.   
D.  Public Comments  
We received over 150 comment s from accreditation bodies, certification bodies, members 
of the food industry, industry associations, foreign governments, State governments, public 
health organizations, public advocacy groups, individual consumers, consumer groups, and 
others.  Some su bmissions included signatures and statements from multiple individuals.  Taken 
as a whole, the c omments address virtually every provision of the proposed rule .  In the 
remainder of this document, we describe the  comments that are within the scope of this 
rulemaking , respond to them, and explain any revisions we made from the proposed rule.   
A number of  comments focus on the overarching issues of :  (1) Alignment with voluntary 
consensus standards; (2) the u se of private food safety schemes; (3) the relation ship between the 
third -party certification program , foreign competent authorities , and FDA’s international 
activities ; and (4) the possible implications of the lack of qualified auditors  on the third -party 
certification program .  We address  these comments generally below.  
We received several  comments  on the overarching issue of the use of voluntary 
intern ational consensus standards issued by the International Organization for Standardization 
(ISO) and the International Electrotechnical Commi ssion (IEC) , including  the following 
ISO/IEC standards:  ISO/IEC 17000:2004 Conformity assessment --Vocabulary and general 
principles  (ISO/IEC 17000:2004)  (Ref. 4); ISO/IEC 17011:2004, Conformity assessment --
General requirements for accreditation bodies acc rediting conformity assessment bodie s 
(ISO/IEC 17011:2004) (Ref. 5); ISO/IEC 17021:2011, Conformity assessment --Requirements 
for bodies providing audit and certification of management syste ms (ISO/IEC 17021:2011) (Ref. 20 
6); ISO/IEC 17065:2012, Conformity assessment --Requirements for bodies certifying products, 
processes and services (ISO/IEC 17065:2012) (Ref. 7); and ISO/IEC 19011:2011, Guidelines for 
auditing management systems (ISO/IEC 19011:2011) (Ref.  8).  
Some comments support the approach to ISO/IEC standards that we used  when 
developing the proposed rule ; some comments state that the process for developing these 
standards makes them unbiased.  Other c omments suggest we should place greater reliance on 
ISO/IEC  standards , including some comments asserting that we should incorporate ISO/IEC 
standards by reference into th e final  rule.  Thes e comments encourage us to follow the example 
of a proposed rule issued by the Environmental Protection Agency and entitled, “ Formaldehy de; 
Third -Party Certification Framework for the Formaldehyde Standards for Composite Wood 
Products” (78 FR 34795, June 10, 2013 ), which proposed to incorporate by reference certain 
international standards.  The se comments assert that by placing greater  reliance on ISO 
standards, we could allow ISO’s broader oversight program to complement FDA’s management 
of these bodies.  
Implementation of section 808 of the FD&C Act occurs against the backdrop of the 
broader Federal policies on consensus standards and conformity assessment under the National 
Technology Transfer and Advancement Act of 1995 (NTTAA) (Pub . L. 104-113).   The NTTAA, 
together with the Office of Management and Budget (OMB) Circular A -119, revised February 
10, 1998 ( 63 FR 8546, February 19, 1998 ), directs Federal Agencies to use voluntary consensus 
standards in lieu of government -unique standards except where inconsistent with law or 
otherwise impractical.   OMB Circular A -119 states that the use of voluntary standards, whenever 
practicable and ap propriate, is intended to eliminate the cost to government of developing its 
own standards and decrease the cost of goods procured and the burden of complying with 21 
Agency regulation; provide incentives and opportunities to establis h standards that serve na tional 
needs; encourage long -term growth for U.S. enterprises and promote efficiency and economic 
competition through harmonization of standards; and further the policy of reliance upon the 
private sector to supply government needs for goods and services . 
As directed  by OM B in Circular A -119, the National Institute of Standards and 
Technology (NIST), in the Federal Register  of August 10, 2000 (65 FR 48894), issued policy 
guidance on Federal conformity assessment activities (defined as activities concerned with 
determining directly or indirectly that requirements for products, services, systems, and 
organizations are fulfilled) (15 CFR 287.2).  The Federal conformity assessment guidance  is 
codified at 15 CFR part 287  and  applies to all Federal Agencies that set policy for, manage, 
operate, or use conformity assessment activities or results, domestically and internationally 
(except for activities conducted pursuant to treaties) and is intended to eliminate unnecessary 
duplicat ion and complexity in conformity assessment requirements.  (We note that OMB has 
announced it is currently revising Circular A -119, and NIST is revising the Federal conformity 
assessment guidance. )   
We agree with comments on the value of promoting internat ional consistency and tapping 
into an existing framework of consensus standards that is familiar to industry, which may make it 
easier for accreditation bodies, third -party certification bodies, and eligible entities to comply 
with this rule .  Therefore, w e are revising the rule to allow for accreditation bodies and third -
party certification bodies to use documentation of their conformance with ISO/IEC standards in 
meeting the program requirements under  this rule , supplemented as necessary.   We are not, 
however, incorporating these standards by reference  into the rule as further discussed in  our 
responses  to comments in sections III. to XIII. , except that we are not further responding to 22 
comments citing specific requirements of ISO/IEC Guide 65:1996, Confo rmity assessment --
Requirements for bodies providing audit and certification of management systems (ISO/IEC 
Guide 65:1996) (Ref. 9) in sections III. to XIII. , because that standard has been withdrawn and 
replace d by ISO/IEC 17065:2012 (Ref. 7) in September 2015 .  Comments referring to ISO/IEC 
17020:2012, Conformity assessment --Requirements for the operation of various types of bodies 
performing inspection (ISO/IEC 17020:2012) (Ref. 10) are outside the scope of this rulemaking, 
because that standard relates to inspection s and not the auditing and certification activities that 
will be performed under this rule.   Therefore, we are not responding to comments citing to 
ISO/IEC 17020:2012, Conformity assessment --Requirements for the operation of vario us types 
of bodies performing inspection (ISO/IEC 17020:2012) (Ref. 10) in sections III. to XIII .  
We also received several comments on the overarching issue of using private food safety 
schemes as audit criteria for regulatory audits conducted under the third -party certification 
program.  Some  comments suggest that FDA should rely on private food safety schemes , 
particularly those that  have been benchmarked by the Global Food Safety Initiative (GFSI) , as 
the audit criteria for regulatory audits of eligibl e entities under the third -party certification 
program.  Other comments suggest that FDA should establish requirements for accreditation 
bodies and third -party certification bodies that are similar to those required by GFSI, such as 
GFSI requirements relat ing to accreditation under relevant ISO/IEC product certification or 
management system standards.   
By way of background, a group of international retailers established GFSI in 2000 with 
the goal of reduc ing the need for duplicative third -party audits by benchmarking private food 
safety schemes against a harmonized set of criteria for food safety and management systems ( see 
78 FR 45782  at 45788; July 29, 2013).  Under current GFSI criteria, a food safety sche me must 23 
have a commitment with one or more accreditation bodies for certification bodies that operate in 
conformance with either the product certification standard, ISO/IEC Guide 65, or the 
management system standard, ISO/IEC 17021:2006 (supplemented by IS O/TS 22003 ).  GFSI 
describes these standards as having similar requirements for how a certification body must 
operate --e.g., in addressing issues of preventing conflict of interest, managing customer 
information, properly qualifying personnel, auditor cali bration, and many other aspects involved 
with the certification process.  However, as GFSI noted in a 2011 White Paper (Ref. 11), there is 
a distinct difference between the two.  ISO 17021/ISO 22003 is not product specific.  ISO/IEC 
Guide 65, on the other hand, is concerned with verifying that particular products or services meet 
specified requirements.  The type and scope of GFSI benchmarked scheme selected, determines 
the accreditation standard which applies.  The majority of GFSI recognized  schemes fall under 
ISO/IEC Guide 65 accreditation requirements, whereas only two currently recognized  schemes 
are management system schemes accredited to ISO 17021/ISO  22003.    
Comments su ggesting that we should rely on GFSI -benchmarked food safety schemes  or 
other pri vate food safety schemes  as the criteria for certification under the third -party program  
are outside the scope of this rulemaking .  This rule establishes the framework for the third -party 
certification program , and not the food safety standards  that accred ited third -party certification 
bodies will use to determine an eligible entity ’s compliance with the applicable food safety 
requirements of the FD&C Act and FDA regulations .  We are however responding to relev ant 
comments that address audit quality and aud itor competency, consistency, and capacity, 
including comments referencing GFSI’s work in these areas.    
Other overarching comments ask how the FSMA third -party certification program relates 
to the roles of foreign com petent authorities and to F DA’s international activities.  Some 24 
comments assert that competent authorities should be allowed to participate in the third -party 
certification program purely by administrative procedures without a formal review process. 
Other comments suggest that g overnment agencies with both regulatory and trade promotion 
missions face inherent conflicts of interest.   
Some comments recommend  that we should establish a different structure for accrediting 
third -party certification bodi es that already have been a pproved by a foreign government 
accreditatio n body .  Other c omments suggest that  FDA should reserve the role of accreditation 
body or third -party certification body for a national competent authorit y that requests it .  The 
comments argue that the responsibility for monitoring the safety of food exports should remain 
with the national competent authorities in each country.    
Some comments ask whether a national competent authorit y has a role in auditing and 
certification activities occurring in the country , includ ing in countries  where an FDA foreign 
office is located.  Other comments ask  whether the competent authority may perform other 
activities in the third -party certification program, such as authenticat ion of audit information  
before it is submitted to FDA .  Still other comments suggest that FDA require accredited third -
party certification bodies to review correspondence between an audited eligible entity and the 
competent authorities in the country where the eligible entity is located.    
Section 808 of the FD &C Act expressly provides for both public and private accredited 
third -party certification bodies.  Public accreditation bodies  and third -party certification bodies , 
as well as private accreditation bodies and third -party certification bodies that meet the eligibility 
requirements for recognition and accreditation under section 808 of the FD&C Act and this rule 
are equally eligible to participate in the  third -party c ertification program.  This includes  
government accreditation bodies and certification bodies in countries where FDA has a foreign 25 
office , as well as government agencies with the dual missions of food safety and trade 
promotion .  We believe that both publi c and private third -party certification bodies  and 
accreditation bodies are capable of exhibiting the competency, capacity, and impartiality 
necessary to meet the letter and spirit o f the law and this regulation.  
By bec oming an accredited third -party certi fication body or a recognized accreditation 
body , a competent authority for food safety or a foreign accreditation body would establish a role 
in the  third-party certification program.  Only if competent authorities  are accredited under this 
rule, may they issue food and facility certifications under section 808 of the FD&C Act.  (We 
note, however, that FDA may require certifications from competent authorities under section 
801(q) of the FD&C Act for foods that FDA determines meet the criteria set forth in that section 
(see 801(q)(3)(A) of the FD&C Act), regardless of whether the competent authorit ies are  
accredited .)  We acknowledge that the third -party certification program that is the subject of this 
rule is narrowly tailored and only a  small piece of the much larger modernized,  prevention -
oriented food safety system we are establishing under FSMA .  Broader FSMA activities a re 
outside the scope of this rulemaking , as are matters covered by FDA’s information sharing 
arrangements with foreign competent autho rities .  
We received other comments on the overarching issue of how the third -party certification 
program fits into FDA’s international activities.  Some comments assert  that, for countries with a 
systems recognition agreement with FDA, there should be no need for a (direct or indirect) role 
for FDA in monitoring accredited third -party certification bodies.  Other comment s encourage us 
to recognize their national food safety s ystem as equivalent to that of the U nited States.  
The systems recognition initiative is a food safety regulatory cooperation program that 
allows FDA to take into account the role of food safety systems of exporting countries in our 26 
risk-based decisionmaki ng.  We are using systems recognition as a tool to determine when we 
can rely on the implementation of science -based food safety programs by foreign regulatory 
authorities and take action based on information provided by such authorities.    
We note that a  competent authority with whom FDA has a systems recognition 
agreement must apply for recognition to make accreditation decisions and apply for accreditation 
to issue certifications under section 808 of the FD&C Act.  If the competent authority applies for 
recognition or direct accreditation by FDA (assuming that the statutory criteria have been met for 
FDA to begin direct accreditation), FDA’s review will be informed by the data, experiences,  and 
insights into the foreign system that FDA gained through the systems recognition review .  
Except as described above, systems recognition activities are outside the scope of this 
rulemaking, as are equivalency determinations.   
We also received several overarching comments noting that the lack of  qualified food 
safety  auditors is a problem in many countries .  Some comments suggest that we may face 
similar problems with the availability of accredited third -party certification bodies  in our 
program .  The comments assert that we should prioritize the review of applications from foreign 
countries with significant volumes of exports to the United States  because of the cost and 
inconvenience to foreign suppliers and the likely trade disruption that would result if the only 
accredited third -party certification bodies were located in other  countr ies.  Some  comments 
predict that rapid expansion in the field of food safety auditing may result in shortcuts in 
auditing .  Other comments contend that because of the limited avai lability of qualified auditors  
we should adjust the timeframes for accredited third -party certification bodies to submit 
information  to FDA  under the regulations .  The  comments specifically request that we l engthen 
the 45-day timeframe for submitting regul atory audit reports.   27 
We acknowledge th e concerns about cost, inconvenience, and disruption resulting from 
auditor capacity issues .  We  are encouraging broad program participation to minimize the 
likelihood that capacity issues might emerge, because c ertifications issued by accredited third -
party certification bodies  under this program  are intended to facilitate trade .  The certifications  
are used in meeting the eligibility requirements of VQIP for expedited entry of food under 
section 806 of the FD&C Act and in satisfying a condition of admissibility for a food subject an 
FDA determination under section 801(q) of the FD&C Act.  
Revisions have been made to this rule made in response to comments, such as allowing 
accreditation bodies and third -party certi fication bodies to use documentation of their 
conformance with ISO/IEC standards  in support of their applications .  We also are modifying 
our “first in, first out” approach to processing applications , as comments request, to allow for 
prioritiz ing specific  applications and requests based on program needs.  We are unable to 
accommodate the request to lengthen the timeframe for submission of regulatory audit reports to 
FDA, because the 45 -day deadline for submission is established in section 808 (c)(3)(A)  of the 
FD&C Act.  Audit protocols and other requirements of the rule are designed to prevent audit 
agents (auditors) and third -party certification bodies from taking shortcuts that would jeopardize 
audit results . 
Some comments addressed the Model Accreditation Standards that FDA is required to 
develop under section 808(b)(2) of the FD&C Act for use in qualifying third -party certification 
bodies for accreditation.  Some of these comments suggest various criteria to be included in the 
model standards.  Other comments suggest the proposed rule was ambiguous with respect to the 
form of, and manner by which, FDA will establish the Model Accreditation Standards.   28 
While the substance of the Model Accreditation Standards i s outside the scope of this 
rulemaking, we note that on July 24, 2015, FDA published a draft guidance on Model 
Accreditation Standards.  The draft guidance can be accessed at: 
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformatio n/ucm
455328.htm .  Additionally, a notice was published in the Federal Register  (80 FR 44137, July 24, 
2015) of the availability of the draft guidance and of the opening of a docket for public 
comments on the document.  As explained in the draft guidance, s ection 808(b)(2) of the FD&C 
Act requires FDA to develop Model Accreditation Standards that recognized accreditation 
bodies shall use to qualify third -party certification bodies for accreditation, and in so doing, to 
look to existing standards for certific ation bodies (as of the date of enactment of FSMA) to avoid 
unnecessary duplication of efforts and costs.  The draft guidance contains FDA 
recommendations on third -party certification body qualifications, including recommendations 
based on relevant provisi ons in the proposed rule.  This final rule will serve as a framework for 
the Model Accreditation Standards final guidance, which will include more detailed 
recommendations  on third -party certification body qualifications .  
Some comments respond to our requ est for input on the question about  the value of, and 
possible need for, FDA to establish a program for use of accredited third -party certification 
bodies to conduct domestic food safety audits (78 FR 45782  at 45823).   We received comments 
on all sides, ex pressing various views.   We are taking these comments under advisement at this 
time, as the focus of this final rule is on establishing and implementing the third -party 
certification program set forth in section  808 of the FD&C Act . 
Other  comments addressed the substance of VQIP, import certification, laboratory 
accreditation, and provisions in the proposed FSVP rule and/or other FMSA rules  that are 29 
outside the scope of this rulemaking; accordingly we will not be responding to those commen ts 
here.  Other comments that fall outside the scope of this rulemaking, and to which we will 
therefore not be responding, include comments on the value of a universal, mandatory food 
safety system; comments advocating for policies promoting locally grown produce; comments 
addressing the information technology in frastructure needs of the third -party certification 
program ; comments suggesting the value of student interns to the food safety system; and 
comments on factors beyond the use of third -party  audits that FDA should consider in setting 
inspection priorities.    
We also received a few comments concerning the rulemaking process.  Comment s 
suggest that we devise a new process for regularly updating the rule; they state that FDA has 
cumbersome requirements for modifying rules.  FDA ’s current rulemaking process is consistent 
with FDA’s obligations under the Administrative Procedure Act (5 U.S.C. 551 -559). 
II.  Legal Authority  
Section 307 of FSMA, Accreditation of Third -Party Auditors, amends the FD&C Act to 
create a new provision, section 808, under the same name.  Section 808(b)(1)(A) of the FD&C 
Act requires us to establish a system, within 2 years of the enactment of FSMA, for the 
recognition of accreditation bodies that accredit third -party certification b odies to conduct food 
safety audits and to issue certifications for eligible foreign food entities and their products  for 
purposes of sections 801(q) and 806 of the FD&C Act . 
Section 808(c)(5)(C) of the FD& C Act directs us to issue implementing regulations for 
section 808 of the FD&C Act.  The regulations must require audits to be unannounced and must 
contain protections against conflicts of interest between accredited third -party certification 
bodies (and t heir audit agents) and the entities they audit or certify, including requirements on 30 
timing and public disclosure of fees and appropriate limits on financial affiliations (21 U.S.C. 
384d (c)(5)(C)(i), (ii) , and (iii)).   
This final rule establishes regulati ons implementing section 808 of the FD&C Act.  The 
authority for the requirements in this rule comes primarily from section 808 of the FD&C Act.  
However, FDA also derives authority for this final rule from other sections of the FD&C Act, 
including section  701(a) of the FD&C Act (21 U.S.C. 371(a)), which authorizes us to issue 
regulations for the efficient enforcement of the FD&C Act.   The regulations in this final rule 
ensure the competency and independence of recognized accreditation bodies and of accredi ted 
third -party certification bodies, which will help ensure the validity and reliability of certifications 
and other information resulting from the food safety audits conducted by accredited third -party 
certification bodies.  These features of the final r ule are essential to the operation of the third -
party program.  This rule also is consistent with section 404 of FSMA (21 U.S.C. 2252), which 
states that nothing in FSMA should be construed in a manner that is inconsistent with the 
agreement establishing t he World Trade Organization or any other treaty or international 
agreement to which the United States is a party.  
This rule establishes requirements for accreditation bodies and third -party certification 
bodies seeking recognition and accreditation, respec tively.  These requirements will help ensure 
that any accreditation bodies that we recognize, and any certification bodies that are accredited, 
are capable of meeting all of the requirements of this program.  This includes requirements, for 
example, for le gal authority and competency and capacity.  It also includes provisions for the 
direct accreditation of third -party certification bodies by FDA in accordance with section 
808(b)(1)(A)(ii) of the FD&C Act.  This rule also establishes requirements for accred itation 
bodies that have been recognized, and third -party certification bodies that have been accredited.  31 
This includes requirements designed to decrease the potential for conflicts of interest in 
accordance with section 808(c)(5)(C)(ii) of the FD&C Act.  Additionally, this rule establishes 
requirements for eligible entities that want to be certified under this program.  This includes 
requirements for onsite audits by FDA for the purpose of monitoring in accordance with section 
808(f)(3) of the FD&C Act.  Finally, this rule establishes general requirements related to the 
operation of this program.  These include requirements for requesting a regulatory hearing on 
revocation of recognition or withdrawal of accreditation.  
Some of the requirements under this f inal rule are also established, in part, under the 
authority in sections 806 and 801(q) of the FD&C Act.  Section 806 of the FD&C Act describes 
a voluntary program to provide for the expedited review and importation of food offered for 
importation from cer tified facilities (VQIP).  Section 801(q) of the FD&C Act gives FDA 
authority to require certifications for imported food in certain situations.  This final rule does not 
set up the framework for participation in the program described under section 806 of the FD&C 
Act, nor does it describe the circumstances under which FDA might require certification under 
section 801(q) of the FD&C Act.  However, this rule does describe circumstances under which 
FDA might refuse to consider a certification issued under thi s program in determining the 
admissibility of an article of food for which the certification was offered under section 801(q) of 
the FD&C Act, or in determining eligibility for participation in VQIP under section 806 of the 
FD&C Act.  Additionally, this ru le creates limited exemptions from the certification 
requirements of section 801(q) of the FD&C Act for certain alcoholic beverages, including 
certain raw materials and ingredients that are used to manufacture/process alcoholic beverages.  
The exemptions a re being promulgated consistent with section 116 of FSMA (21 U.S.C. 2206).  
Section 116(a) of FSMA states that, except as provided by certain listed sections in FSMA, 32 
nothing in FSMA, or the amendments made by FSMA, will be construed to apply to a facility  
that:  (1) Under the Federal Alcohol Administration Act (27 U.S.C. 201 et seq .) or chapter 51 of 
subtitle E of the Internal Revenue Code of 1986 (26 U.S.C. 5001 et seq .) is required to obtain a 
permit or to register with the Secretary of the Treasury as a  condition of doing business in the 
United States and (2) under section 415 of the FD&C Act (21 U.S.C. 350d) is required to register 
as a facility because such facility is engaged in manufacturing, processing, packing, or holding 
one or more alcoholic beve rages (with respect to the activities of such facility that relate to the 
manufacturing, processing, packing, or holding of alcoholic beverages).   This rule also creates 
exemptions  from the certification requirements of section 801(q) of the FD&C Act for products 
subject to the requirements of the U .S. Department of Agriculture (USDA)  under the Federal 
Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq .), the Poultry Products Inspection Act (PPIA) 
(21 U.S.C. 451 et seq .), or the Egg Products Inspection Act (EPIA) (21 U.S.C. 1031 et seq .) at 
the time of importation.  We conclude that this provision is consistent with section 403 of 
FSMA, entitled “Rule of Construction,” which states that nothing in FSMA shall be construe d to 
alter or limit the jurisdiction of the Secretary of the Department of Agriculture.   
III. Comments on What Definitions Apply to This Subpart (§ 1.600)  
We proposed to codify definitions of several terms used in the third -party certification 
regulations .  We received several comments on this section .  As discussed in the following 
paragraphs, we have revised many of the proposed definitions in response to comments  as well 
as on our own initiative .  Where we disagree with comments or decline a suggested r evision, we 
offer an explan ation in response .  Some definitions were finalized as proposed.  
The definitions for terms used in the third -party certification regulations are codified in 
21 CFR  1.600.  33 
A.  Definitions , Generally  
(Comment  1)  Several comment s encourage us to more closely align the definitions in  
§ 1.600 with international standards to promote consistency and common understanding of the 
rule.  The comment s explain that the terms and definitions used in section 808 of the FD& C Act 
and in the proposed rule convey a d ifferent meaning for accreditation bodies, certification 
bodies, and the standards community.  To that end, some comment s encourage us to avoid using 
the term “ third-party auditor” synonymously with “ certification b ody,” to be consistent with 
international standards , which use the term “certification body”  (e.g., ISO/IEC 17065 :2012 
(Ref. 7).   
Similarly, some comment s indicate that, the language of the statute notwithstanding, it is 
not correct to use the term “third-party auditor” when describing the activities of a “third-party 
certification body.”  The comment s explain that auditors are individuals contracted or employed 
by certification bodies to conduct audits , and they urge us to clarify the rule by substituting 
“certification body” for “ third-party auditor.”    
(Response  1)  We agree  that alignment with the terminology used in international 
standards  is preferable , wherever possible.  Congress recognized the value of international 
standards in accreditation and certification , having instructed us in section 808(b)(2) of the 
FD&C Act to look to existing standards in developing our model accreditation standards to avoid 
unnecessary  duplication of efforts and costs.  We believe it is particularly useful to rely on 
definitions and terminology from international consensus standards  when possible  where, as 
here, the rule is establishing a voluntary progra m with an international focus.   In addition, we 
agree that, notwithstanding the use of the term “third -party auditor”  in the statute, the use of the 
term “ third -party certification body” instead of the term “third -party auditor” provides some 34 
clarity for purposes of referring to bodies that employ or contract individuals to perform audits.  
Therefore, i n response to the c omments suggesting the term “ third-party auditor” is 
confusing and inconsistent with international standards, we are using  the term “ third -party 
certification body”  in the remainder of the preamble and in the codified of this  final rule , except 
in the definitions of “ Accredited third -party certification body” and “Third -party certification 
body” in § 1.600(c) and in the preamble discussion of those definitions.  
On our own initiative, we are including the descriptor “third -party” before “certification 
body” throughout this final rule.  We did not use that descriptor  in the proposed rule  when 
referring to a third -party auditor/certification body once accredited .  We are doing so now in 
order that the term accurately reflects that , under this subpart,  only third -party certification 
bodies are eligible for accreditation.   We are making corresponding change s to the term 
“accredited auditor/certification body;” and in this final rule we will instead use the term, 
“accredited third -party certification body.”  
Accordingly , we have revised the proposed definitions of “accreditation,” “ accreditation 
body,” “ accredited  auditor/ certification body,” “ audit,” “ audit agent,” “ certification body,” 
“direct accreditation,” “ eligible entity,” “ facility certification,” “ food certification, ” “recognized 
accreditation body,” “relinquishment,” and “ self-assessment ,” to replace the term “third -party 
auditor” with the term “ third -party certification body ,” or “third -party certification bodies, ” and 
to remove “auditor/” from in  the term “third -party auditor/certification body”  or “third -party 
auditors/certification bodies”  that was used in the proposed rule.  
On our own initiative, we added a sentence to the definition of “ accredited  third -party  
certification body”  in § 1.600  of this final rule to explain that the  term has the same meaning as 
“accredited third -party auditor” as defined in section 808(a)(4) of the FD&C Act.  Similarly, we 35 
added language  to the definition of “third -party certification body” in § 1.600 of this final r ule 
explain ing that the term has the same meaning as “ third-party auditor” as defined in section 
808(a)(3) of the FD&C Act.   
(Comment  2)  Some comment s encourag e us to make the definitions in this rule  
consistent with the definitions in other FSMA proposed rules, such as the 2013 proposed FSVP  
regulation , the 2013 proposed human preventive controls regulation, the 2013 proposed animal 
preventive controls regulation, and the  2012 proposed produce safety regulation , where feasible.   
(Response  2) We a gree with the comment s on the overarching goal of align ment  across 
regulations and accepted suggested revisions, where feasible and appropriate .  However, it is not 
always possible to develop uniform definitions due to the distinct statutory requirements and the 
framework of each program.  In such cases  where it was not feasible or appropriate , we declined 
the suggested revisions  from comment s.  We discuss such comment s and our response s under 
each relevant term.   
B.  Assessment  
We did not define “assessment” in the proposed rule.  
(Comment  3)  Some comment s recommend adding a definition of “assessment” based on 
ISO/IEC 17011:2004 (Ref.  5), clause 3.7, which d escribes the process for evaluating  certification 
bodies .  The comment s explain that defining such evaluations as “ audits ,” as we had proposed , is 
inconsistent with international standards .  The comment s suggest consulting with other ISO/IEC 
standards for relevant terminology.  
(Response  3)  We agree  that the te rm “assessment” should be used, in part, to refer to the 
activity undertaken to assess the competency and capacity of a third -party certification body  
under the rule .  We reviewed ISO/IEC 17011:2004  (Ref. 5) (clause 3.7 and NOTE)  and ISO/IEC 36 
17000:2004  (Ref. 4), ISO/IEC 17040:2005 Conformity assessment --General requirements for 
peer assessment of conformity assessment bodies and accreditation bodies (ISO/IEC 
17040:2005) (Ref.  12), and an International Acc reditation Forum (IAF) document entitled , “IAF 
Endorsed Normative Documents” (Ref . 13).  
After considering the comment s and reviewing  the referenced documents, we developed 
a definition of “ assessment” that describes , with respect to accreditation bodies,  the activity 
undertaken  by FDA  to evaluate the competency and capacity of  the accreditation bod y under the 
applicable requirements of this rule.  With respect to  certification bodies , “assessment” describes 
the activity undertaken by a recognized accreditation body (or, in the case of direct accreditat ion, 
FDA) to evaluate the competency and capacity of a certification body under the applicable 
requirements of this rule .  We also made c orresponding changes to the definition of “ audit” from 
proposed  § 1.600 (c) by remov ing clauses (1) and (2).   
C.  Audit  
We proposed a definition of “aud it” describing the examination  of accreditation bodies, 
third -party certification bodies, and eligible entities.  We proposed to define an audit of an 
accreditation body  as an examination by FDA of the accreditation body’s a uthority, 
qualifications,  resources , policies, procedures, and performance, as well as of its capability to 
meet the requirements of the proposed rule.  We proposed to define  an audit of a  third -party  
certification body as an examination by a recognized ac creditation body (or, by FDA, for direct 
accreditation) of the  third -party  certification body’s authority, qualifications, resources, policies, 
procedures, and performance, as well as of its capability to meet the requirements of the 
proposed rule.   We pro posed to define an audit of an eligible entity as an examination by an 
accredited  third -party  certification body of the eligible entity to assess the entity, its facility, 37 
system(s), and food using audit criteria for consultative or regulatory audits, and,  for consultative 
audits, also includ ing an assessment of compliance with applicable industry standards and 
practices.  
We received some comments on the proposed definition of “audit,” and the related 
definitions of “consultative aud it” and “regulatory audi t.”  Comments specific to the definition of 
“consultative audit ” are discussed in section III.E., and comments on the definition of 
“regulatory audit” are discussed in section III.L.  As described in Response 3, we also removed 
clauses (1) and (2) from the  proposed definition of “ audit” because those evaluations are 
“assessments” as the term is defined in § 1.600(c).   
On our own initiative, we are revising the definition of “audit” to clarify that an audit 
conducted under this subpart is not an inspection under section 704 of the FD&C Act  (21 U.S.C. 
374). 
(Comment  4)  Several comment s encou rage us to align our definition  of audit  with 
relevant international standards , and some comment s request  that we use the definition of “ audit” 
from t he Codex “Principles  for Food Import and Export Inspection and Certification ” (CAC/GL 
20-1995) (Ref . 14), which define s “audit” as a “ systematic and functionally independent 
examination to determine whether activities and related results comply with planned objectives.”   
(Response  4)  We agree  with the general principle of creating consistency with 
international standards  and have revised the definition of “audit” in § 1.600(c)  accordingly.  
Rather than describing the determination of whether activities comply with  “planned objectives”  
that appears in the Codex definition of “ audit” (Ref . 14), we inserted  a brief description of the 
objectives of consultative and regulatory audits  from the definitions in section 808(a)(5) and (7) 
of the FD&C Act  (i.e., the  examinatio n of an eligible entity under this rule) .  38 
(Comment  5)  Some comments encourage us to remove the proposed definition of 
“audit” in § 1.600(c) and substitute the FSVP definition of “audit” instead, to promote 
consistency and a common understanding of terminology.   
(Response  5)  We disagree.  We believe that it  is more important for the definition in this 
rule to reflect international standards that are generally well known to the parties subject to this 
rule than it is for the definit ion to mirror the definition in FSVP, which has different 
applicability.  FSVP applies to importers; this rule applies to accreditation bodies,  third -party  
certification bodies, and eligible entities.  Therefore, we are rejecting the suggestion to use the 
FSVP definition of “audit” as the definition of “audit” in § 1.600(c).   
(Comment  6)  We received some comments on the definition of “ audit” regarding its 
relationship to  the related definitions of “ consultative audit” and “ regulatory audit” in § 1.600(c).   
Some comment s recommend that we revise the definition of “ audit” to mean only regulatory 
audits, and not consultative audits, asserting that is how  the word “audit” is used in the statute.  
These comment s contend  that the statute must be interpreted in light of the fact that section  808 
of the FD&C Act  is directed to food and facility certifications, which are only accomplished 
through regulatory audits.  Other comment s ask us to clarify that the services of an ac credited 
third -party certification body that fall short of the definition of an “audit” (e.g., informal 
consulting, continuous improvement programs, and limited purpose audits)  under this rule, are 
not subject to the requirements of the rule.  
(Response  6)  We decline the suggestion to interpret section 808 of the FD&C Act in a 
manner that would eq uate “audit” with “ regulatory audit .”  Section 808 of the FD&C Act defines 
two types of audits  used under the program , consultative audits and regulatory audits, and 
contains requirements relating to each.  (See, e.g., section 808(a)(5), (7), and (c)(3)(A) of the 39 
FD&C Act).  In addition, section 808(c)(4)(B) of the FD&C Act expressly allows an accredited 
third -party certification body or an audit agent of such auditor to perform consultative and 
regulatory audits of eligible entities.  
To the extent that other comment s suggest  creating  a list of exceptions from the definition 
of “audit”  in the codified for this rule,  we d ecline to do so .  To the extent that the se comment s 
were seeking clarification of the definition of “ consultative audit” in § 1.600(c) , and what types 
of activities might fall outside of that definition as well as outside of this program, please see the 
discussion in  Response 9 in section II I.E. 
(Comment  7)  Some comment s express confusion about the criteria that accredited third -
party certification bodies will be using in conducting audits under subpart M and ask us to more 
clearly describe the “appl icable requirements” against which compliance will be evaluated.   
Some comment s are concerned that eligible entities might be audited against requirements that 
do not apply to their operations.  For example, some comment s note that firms subject to the 
final animal preventive controls regulation  should not be assessed for compliance with the 
allergen cross contamination requirements of the final human preventive controls regulation .  
Other comment s ask us to clarify whether the “applicable requirements” are limited to 
requirements that appear  in the FD&C Act or  FDA regulations , or both.  
(Response  7)  During regulatory and consultative audits, accredited  third -party 
certification bodies will examin e compliance with applicable food safety requirements of the 
FD&C Act and FDA regulations  within the scope of the audit .  In consultative audits, the third -
party certification bodies also may be conducting an examination to determine conformance with 
applica ble industry standards and practices.   40 
The applicable requirements that accredited  third -party  certification bodies and their audit 
agents will use relate to the  food safety  standards under the FD&C Act , such as the adulterated 
food provisions in section  402 of the FD&C Act and the provisions on the misbranding of food 
allergens in section  403(w) of the FD&C Act .  The applicable  requirements of the FD&C Act 
and FDA regulations would depend on the type of eligible entity being audited .  To use the 
example g iven by one of the comment s, an eligible entity that is subject to  the requirements of 
the final a nimal preventive controls  regulation , but not the final h uman  preventive controls  
regulation , would not be subject to an audit examining its practices relatin g to cross -
contamination by food allergens under the final h uman preventive controls  regulation  because 
those are not  “applicable food safety requirements” for such an entity.    
To help clarify this rule for eligible entities,  third -party  certification b odies, and 
accreditation bodies  who may be interested in participatin g in the program and who may not yet 
be familiar with U.S. laws an d regulations, we are using the phrase “applicable food safety 
requirements of the FD&C Act and FDA regulations ” in place  of the phrase “applicable 
requirements”  in the definition of “ audit” in § 1.600(c) and elsewhere throughout the rule  where 
we are discussing the requirements that will be used in auditing eligible entities .2   
D.  Audit Agent  
We proposed to define an “ audit agent” as an individual who is an employee or other 
agent of an accredited  third -party  certification body who, although not individually accredited, is 
qualified to conduct food safety audits on behalf of an accredited  third -party  certification body.  
                                                 
2 Although we have elected to cite to both the FD&C Act and FDA regulations in  this definition , we otherwise will 
follow the conventional practice of using the words “applicable requirements” to refer the applicable requirements 
of the FD&C Act and FDA regulations.   41 
Under the proposed rule we also defined a n audit agent to include a contractor of the accredited 
third -party certification body.  
(Comment  8)  Some comments express concern about our proposal to allow a contractor 
of an accredited third -party certification body to serve as an audit agent, asserting that “[w]ith 
each step that is further removed in this process, institutional control is lost exponentially.”  The 
comments point  out that a subcontractor conducted the audit and gave a passing audit score to a 
cantaloupe farm and packing facility that used “improper and unsafe processing equipment” and 
subsequently was linked to a deadly outbreak caused by Listeria monocytogenes .  Other 
comments mentioning the incident cite to an article in Bloomberg News explaining that auditors 
often outsource to independent contractors over whom they do not  have direct management 
control  (Ref. 15).  Still other comments offer the cantaloupe outbr eak as an example of why 
auditors must be competent and accountable for their activities.  
(Response  8)  We understand that  third -party  certification bodies currently work with 
individual auditors under many different types of arrangements .  We acknowledge concerns 
raised by comments about recent outbreaks at some domestic facilities that had received 
satisfactory scores in food safety audits.  Further, w e agree with the comment s on the importance 
of an accredited third -party certification body exercis ing adequate control over an audit agent 
conducting audits on its behalf .  We believe that principle is equally true whether the audit agent 
is an employee or a contract auditor .   
International standards , such as ISO/IEC 17021:2011 (Ref . 6), specifically all ow 
accredited third -party certification bodies to use contractors to perform audits if certain 
conditions are met.  Among other condi tions , contract  auditor s must meet the same level of 
qualifications (e.g., knowledge, skills, and experience ) and the same requirements for 42 
impartiality and objectivity as do the auditors the  third -party  certification body employs.  T he 
third -party certification body must exercise adequate control and oversight  over a contractor such 
that the third -party certification body accepts the result of the contractor’s audit  as its own.   
When we proposed to define “ audit agent” to include a contractor , we were 
contemplating arrangements such as those described in ISO/IEC 17021:2011 (Ref. 6) that 
involve a direct relationship betwee n the accredited third -party certification body and its 
auditors.  We are revising the definition of “ audit agent” to clarify that we are excluding 
subcontractors  and other types of outsourcing arrangement s; we have concluded th at such 
arrangements fail to provide the degree of control and oversight necessary  for an accredited 
third -party certification body to ensure that its audit agents are competent and objective.   An 
accredited third -party certification body exercises direct  supervision over the activities  of its 
employee s, and has a direct relationship with a contractor ; but the relationship between the third -
party certification body and a subcontractor or other type of outsourced staff is attenuated – the 
third -party certifi cation body may not even choose such persons and may not have any direct 
authority over them.  We do not believe such diminished oversight  is appropriate , given the 
important role of audit agents in this program.    
By revising the definition of “ audit agent” we are not prevent ing an accredited  third -party 
certification body from subcontracting for services  in areas other than the conduct of audits .  For 
example, an accred ited third -party certification body may use subcontractors or other 
outsourcin g arrangements to deliver annual training to its audit agents under § 1.650 or may use 
subcontractors or other outsourcing arrangements to investigate and decide on appeals of adverse 
regulatory audit results u nder § 1.65 1.  However, we are limiting the ro le of “audit agent” to 
employees and cont ractors of the accredited third –party certification body.    43 
E.  Consultative A udit 
We proposed to define a “consultative audit ” as an audit of an eligible entity:   (1) To 
determine whether such entity is in complian ce with applicable requirements of the FD&C Act 
and industry standards and practices and  (2) the results of which are for internal purposes only 
and cannot be used to determine eligibility for a food or facility certification issued under this 
subpart or i n meeting the requirements for an onsite audit of a foreign supplier under subpart L 
of this part.  
(Comment  9)  We received several comments on the definition of “consultative audit.”  
Many comment s express concern that the definition of “consultative audit” is overly broad  and 
that some of the requirements that would apply to consultative audit s under the proposed rule 
might create a disincentive to using accredited third -party certification bodies .  Some comments 
urge FDA to remove all requirements associated with consultative audits from the rule.  Other 
comments identify two requirements of particular concern:  (1) Proposed § 1.656, requiring an 
accredited  third -party  certification body conducting a  consultative audit or regulatory audit under 
the rule to notify FDA immediately upon discovering a condition that could cause or contribute 
to a serious risk to public health (the notification requirement) and (2) proposed § 1.652, 
requiring an accredited  third -party  certification body to provide FDA access to a consultative 
audit report when the criteria for records access under section 414 of the FD&C Act (21 U.S.C. 
350c) are met (the records access requirement).  The comment s explain that many firms  use 
certification bodies (and/or their consulting divisions ) to help establi sh, maintain, and improve 
their food safety practices.   For example, some firms use certification bodies (and/or their 
consulting divisions) to help in identifying root causes and remediating food safety problems .  
Comment s also note that certification bodies (and /or their consulting divisions) provide informal 44 
counseling,  perform preliminary evaluations, limited purpose audits, and activities in suppo rt of 
firms’ continuous improvement programs.   
Comment s express concern that if these types of activities are subject to notification , 
records access , and other  requirements of the rule, firms located outside the United States might 
not use accredited  third -party  certification bodies , instead choosing unaccredited third -party 
certification bodies to avoid the requirements of this rule.   The comment s assert that 
unaccredited  third -party  certifi cation bodies are less likely to have qualified auditors and their 
independence and objectivity is less certain , than third -party certification bodies that have been 
evaluated and issued accreditation .   
Comment s also argue that the definition of “ consultative audit,” which states that the 
results of such an aud it are “for internal purposes only,” is inconsistent with  the requirements for 
notification and records access that would apply to consultative audits under the proposed rule.  
Other comment s ask us to  clarify that audits conducted for external purposes --for example, an 
audit for purposes of  compliance with FSVP --do not satisfy the definition of a consultative audit 
because consultative audits are for internal purposes only.  
Some comment s suggest that the proposed d efinition of “consultative audit,” taken 
together with the proposed definitions of “food safety audit” and “regulatory audit ,” could 
preclude third -party certification bodies from conducting any audits that are outside the scope of 
subpart M , once accredited .  Based on that interpretation, the  comment s predict that few if any 
third -party certification b odies w ould want to participate in the program .   
Many of the comment s that express concern about disincentives also sug gest that 
Congress intended the third -party program to be much narrower than our proposed definition of 
“consultative audit” would suggest.  These comment s suggest  that the FSMA third -party  45 
certification  program was intended to be focus ed on regulatory audits and the issuance of 
certifications to be used for two limited purposes: i .e., in establishing an importer’s eligibility for 
VQIP and in satisfying a condition of admissibility for a food subject to an FDA safety 
determination under section 801(q) of the FD&C Act.  These comment s argue further that  
Congress inserted the term “ consultative audit” in the statute to be used only in reference to the 
conflicts of interest provisions in section 808(c)(4)(C) and (c) (5) of the FD&C Act ; therefore, a 
broad interpretation of “ consultative audit” is inconsistent with Congressional intent.  The 
comment s urge us to construe the term “ consultative audit” as narrowly as possible.   
(Response  9)  We  recognize that food firms use accredited third -party certification bodies 
(and their consulting divisions ) in various capacities that serve the ulti mate goal of improving 
food safety.  We do not want, nor do we believe Congress intended, for our third -party 
certification program to create disincentives  for food firms seeking to us e accredited third -party 
certification bodies for various purposes to improve food safety practices in their operations .  
Nevertheless, we decline the request to remove all requirements relating to consultative audits 
from this final rule.  Section 808(c)(5)(C) of the FD&C Act directs us to issue implementing 
regulations for section 808 of the FD&C Act, which includes some specific provisions relating to 
consultative audits (e.g., section 808(c)(3)(A) and (C) on consultative audit reports and section 
808 (c)(4)(C) of the FD&C Act on audit agents performing regulatory audit s of eligible entities 
of which they performed consultative or regulatory audits within the preceding 13 months).  We 
have, however, revised the definition of “consultative audit” as explained below and have made 
other revisions to the rule to clarify the scope of such audits and help mitigate possible 
disincentives to conduct consultative audits, while fulfilling the letter and spirit of the law.  46 
With regard to the comment s expressing  concerns about an overly broad interpretation of 
“consultative audit ,” we remind readers that the statute endows both regulatory and consultative 
audits with certain characteristics.  For example, section  808(a)(6) of the FD& C Act indicates 
that an eligible entity must choose to be audited by an accredited third -party certification body, 
and section  808(c)(5)(C)(i)  of the FD&C Act  states that audits under this program must be 
unannounced.  We understand these provisions to mea n that, at the time the audit services are 
arranged, an eligible entity must specifically request from an accredited third -party certification 
body a  food safety audit under this rule --that is the only way the accredited third -party 
certification body woul d know that the eligible entity is requesting an unannounced subpart M 
audit to determine compliance with the applicable food safety requirements of the FD&C Act  
and FDA regulations .  Further, the eligible entity would need to specify whether it is seeking  a 
regulatory or consultative audit .  (In addition to determining whether the eligible entity is in 
compliance with the food safety requirements of the FD&C Act, consultative audits under 
section 808 of the FD&C Act also determine whether the eligible enti ty is in compliance with 
applicable industry standards and practices) .  Audits that fall outside the purview of this rule --for 
example, audits that are conducted by  third -party  certification bodies that are not accredited 
under this program, audits that de termine compliance with standards other than the food safety 
requirements of the FD&C Act  and FDA regulations (e.g., audits that determine compliance with 
private standards) , audits that are announced, and audits conducted solely for the purposes of 
supplier verification under the final human or animal preventive controls regulations or the final 
FSVP regulations --are not covered by, or subject to, th e requirements of th is rule.  
It is impossible to describe or predict all of the audit scenarios that m ay occur.  We 
emphasize that a n accredited  third -party  certification body  can continue to offer auditing and 47 
certification services that are outside the scope of this rule, such as on -site supplier verification 
audits under the final h uman   or animal  food preventive controls  regulations  or the final FSVP 
regulation .  Such audits would not be subject to the requirements of this rule, including the 
reporting and notification requirements.   
In response to comment s, we revised the proposed definition of “consu ltative audit”  to 
clarify that it is an audit conducted in preparation for a regulatory audit  under the third -party  
certification  program .  A consultative audit would thus be a pre -examination or pre -assessment 
type of activity imbued with certain characteristics.  We further clarify the characteristics of a 
consultative audit, as well as of a regulatory audit  (the results of which can form th e basis for 
issuance of certification under the rule) , in the definition of “food safety audit” discussed in 
section III. J. 
F.  Eligible E ntity 
We proposed to define an “eligible entity ” as a foreign entity that chooses to be subject to 
a food safety audit  by an accredited  third -party  certification body.  We further proposed that 
eligible entities include foreign facilities subject to the registration requirements in FDA 
regulations.  
(Comment 10)  We received several comments on the definition of “eligible entity.”  
Some comment s request that we provide examples of specific types of entities that satisfy the 
definition.  Some comment s offer  examples  of “eligible entities ,” including orchards or fa rms, 
packing houses, processing plants, and storage facilities.   Other comment s suggest we add “and 
foreign farms” to the end of the definition, to clarify that such entit ies are eligible to receive 
audits  under subpart M .  Some comment s encourage us to ad just the definition of “eligible 48 
entity” to make it mandatory for foreign food facilities to undergo food safety audits by 
accredited third -party certification bodies.  
(Response  10)  The proposed definition of “eligible entity” was based on the statutory 
definition, which includes facilities subject to the registration requirements in section 415 of the 
FD&C Act that choose to be audited under the program.  At our own initiative we are  revising 
the definition of “eligible entity” in the codified to more accurately track the statute, and we 
decline the suggestion to add specific examples, such as orchards or farms, that are not included 
in the statutory definition of “eligible entity.”  However, as explained in Response 12  we are 
revising the definition of “facility” in § 1.600(c)  to clarify that entities that grow, harvest, or raise 
animals for food for consumption in the United States are facilities that are eligible for auditing 
and ce rtification under this subpart.   
We disagree with the comment suggesting that we should make audits  under this program  
mandatory for all foreign food firms by modifying the definition of “eligible entity.”  The statute 
clearly indicates that participation  in this  program is intended to be voluntary, and only entities 
that choose to be audited under the program are subject to its requirements  (see section  808(a)(6)  
of the FD&C Act ).   
(Comment  11)  In the proposed rule, we specifically asked for comment on whether to 
allow for food or facility certification to be issued to a producer group, offering as an example 
the criteria for groups under the National Organic Program (NOP) --i.e., having multiple sites 
operating under a single managem ent system and whose farms are “uniform in most ways .”  
Several comments responded to this inquiry in relation to the definition of “eligible entity. ”   
Comments in support of certification of a group (e.g., a cooperative being audited as a 
single eligible  entity ) note that some producers are very small and might find it difficult on their 49 
own to obtain third -party certification , but taken as a group the task would likely be more 
manageable.  Other comments note that treating multiples sites with a single m anagement system 
as a single eligible entity could be particularly helpful in sectors or regions where there is a 
scarcity of accredited thi rd-party certification bodies.  Some comments argue in support of 
groups functioning as a single eligible entity as long as the central management system functions 
effectively, providing oversight to the members.  Comments also note that some multisite 
sampling protocols have been developed by international organizations, such as ISO.  
Other comments encourage us to ensu re that cooperatives are subject to this rule, so that 
all the links in a foreign supply chain are appropriately inspected, and so that they are subject to 
any applicable regulations before their product is exported to the U nited States.   
Comments not in support of cooperatives being classified as eligible entit ies note that 
food safety practices and conditions are site -specific and can vary significantly even if the 
individual farms are located in the same geographic area (for example, due to soil composi tion, 
agricultural water runoff, or the manner in which the land was used in the past).  They also note 
that organic production standards and scientifically -based food safety standards are not the same, 
so what works for the NOP may not be appropriate here  
Some comments encourage us to provide guidance on the acceptable parameters of a 
cooperative.  Some comments encourage us to consider guidance available from other sources 
beyond the NOP , such as the International Federation of Organic Agriculture Movemen ts.   
(Response  11)  We decline to revise the definition of eligible entities to include a group.  
We acknowledge that some very small producers might be daunted by the prospect of working 
individually with an accredited third -party certification body, and  there would be obvious 
economies in banding together with other very small producers to gain certification .  We also 50 
acknowledge that some sets of producer s do currently function as a unit under a centralized 
management system , and that group certification may make it easier for entities to access 
accredited third -party certification bodies in areas or regions where they may be scarce .  
Nevertheless, after reviewing the NOP, the International Federation of Organic Agricultural 
Movements, the Ca nada Organic Office Operation Manual, the USDA Agricultural Marketing 
Service pilot program on group certification, and other recommended sources , we conclude that 
it would not be appropriate to  allow groups to be certified under this program.  Group 
certification raises a myriad of complicated issues such as establishing who may act as a group, 
determining the requisites of a central management system, and delineating the minimum 
requirements for accredited third -party certification body audits of a group.     
With regard to the comments contending that certifications from individual eligible 
entities that might otherwise act as a group would create redundant and unnecessary paperwork 
for FDA, we will take that sort of information into account as we gain exp erience with the 
program.   Finally, with regard to the comments encouraging us to define “eligible entit y” to 
include groups to ensure that all their members are examined for compliance with  applicable 
food safety regulations before their food is exported  to the United States , we note that this rule 
does not create audit obligations for all foreign suppliers or for all importers .  The third -party 
certification program created by this rule is a voluntary program for eligible entities who wish to 
participate .   
G.  Facility  
We proposed to define “ facility” as any structure, or structures of an eligible entity under 
one ownership at one general physical location, or, in the case of a mobile facility, traveling to 
multiple locations, which  manufactures/processe s, packs, or holds food for consumption in the 51 
United States.   The definition went on to state that: (1) t ransport vehicles are not facilities if they 
hold food only in the usual course of business as carriers ; (2) a facility may consist of one or 
more contiguous structures, and a single building may house more than one distinct facility if the 
facilities are under separate ownership ; (3) the private residence of an individual is not a facility ; 
and (4)  non-bottled wa ter drinking water collection and distribution establishments and their 
structures are not facilities.    
On our own initiative,  we are clarifying that facilities for the purposes of this subpart are 
not limited to facilities required to be registered under  Subpart H.  
(Comment  12)  Some comment s encourage us to align the proposed definition  of 
“facility ” to the definition of “facility ” in the human   and a nimal  preventive controls , produce  
safety , and FSVP regulations , to promote consistency and common understanding of the rules.   
(Response  12) As previously noted, we agree with the comments on the importance of 
consistency across regulations, where feasible and appropriate.  We reviewed the definitions of 
“facility” in the final FSVP and final human preventive controls regulations, and found those 
definitions to be too narrow in light of the purpose of this rule to establish a voluntary program 
for certification of foods and facilities and the broad definition of “eli gible entity” in section 
808(a)(6) of the FD&C Act.   Of our own initiative, in order to preserve the option for broad 
participation in the third -party  program, we are expressly including in the definition of “facility” 
those entities that grow, harvest, or  raise animals for food for consumption in the United States.  
H.  Facility Certification and Food C ertification  
We proposed to define “facility certification ” as an attestation, issued for purposes of 
section 806 of the FD&C Act by an accredited  third -party  certification body, after conducting a 
regulatory audit and any other activities necessary to establish that a facility meets the applicable 52 
requirements of the FD&C Act.  We proposed to define “food certification ” as an attestation, 
issued fo r purposes of section 801(q) of the FD&C Act by an accredited third -party certification 
body, after conducting a regulatory audit and any other activities necessary to establish that a 
food meets the applicable requirements of the FD&C Act.   
(Comment  13)  We received some comments on the definitions of “facility certification” 
and “food certification.”  Some of these comment s raise group certification issues which we 
address above, in connection with the definition of “ foreign cooperative .”  Some comment s state 
that “food certification” is improper terminology, because it implies a product certification 
model, whereas audits of eligible entities --particularly in the produce sector --generally assess 
processes and/or management systems.  
(Response  13)  The term “food certification” appears in the statute and is specifically 
discussed in the statute as a type of certification that may be used in meeting a condition of 
admissibility under section 801(q) of the FD&C Act.  Under section 808(c)(2)(C)  of the F D&C 
Act, food certifications may only issue upon conduct of a regulatory audit.  In light of the 
statutory language, we decline to revise the term “food certification” in response to the 
comments  on this rule . 
We also note that section 801(q)(1) of the FD& C Act allows for FDA to accept “a listing 
of certified facilities that manufacture, process, pack, or hold food, or other assurances deemed 
appropriate by FDA” to satisfy the condition of admissibility.  Of our own initiative, in light of 
this statutory la nguage, we are clarifying in the definition of “facility certification” that a facility 
certification may be issued for purposes of 801(q) of the FD&C Act.  53 
I.  Food  
In proposed § 1.600(b), we stated unless otherwise defined in § 1.600(c) of the proposed 
rule, definitions of terms in section 201 of the FD&C Act would apply to terms used in this 
subpart.  Section 201 of the FD&C Act defines “food” as “(1) articles used for food or drink for 
man or other animals, (2) chewing gum, and (3) articles used for comp onents of any such 
article.”  Proposed § 1.600(c) did not define the term “food.”  
(Comment  14) Some comments request that we define “food” consistent with how it was 
defined in the FSVP proposed rule for consistency and to indicate that producers of food c ontact 
substances are eligible entities.  
(Response  14)  The proposed definition of “food” under § 1.600 would include pesticides 
when they meet the definition of “food” under section 201 of the FD&C Act.  By contrast, t he 
FSVP rule’s proposed definition of  food explicitly does not include pesticides, as defined in 7 
U.S.C. 136(u), consistent with  the definition of “food” used in the rulemaking on the Prior 
Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness Act of 
2002 (pr ior notice rule).  FDA received comments during that rulemaking questioning the 
applicability of the rule to pesticides, so FDA clarified that “food” for the purposes of that rule 
did not include pesticides.  
The final FSVP regulation , which is publishing elsewhere in this issue of the Federal 
Register , retains the exclusion of pesticides from the definition of “food.”  
In response to comments suggesting revision of the definition of “food” in this rule to be 
consistent with the final FSVP regulation , we considered the purposes that certifications serve 
under this program and the nature of comments we received on the third -party proposed rule, 
including general comments requesting alignment across the FSMA rules and comments 54 
specificall y requesting that we use the FSVP definition of “food.”  Certifications issued by 
accredited third -party certification bodies may be used in establishing an importer’s eligibility to 
participate in VQIP and in satisfying a condition of admissibility for an  impor ted food that we 
determine pose s a safety risk under section 801(q) of the FD&C Act.   
While certifications may be useful in addressing pesticide contamination of food (e.g., 
pesticide levels in food that exceed established tolerances), we have not i dentified a need for 
certifications to address pesticides as articles of food, nor do we anticipate a role for food safety 
audits in pesticide manufacturing facilities.  Accordingly, we are revising the final rule by adding 
to § 1.600(c) a definition of “f ood” that excludes pesticides.  
We also agree with the comment that producers of food contact substances could be 
eligible entities under this rule and that food contact substances should be considered food for 
the purposes of this rule.  Third -party food s afety audits and certifications for food contact 
substances could potentially be useful given the possibility of migration of harmful food contact 
substances into food or contamination of food contact materials that directly contact food .  
Accordingly, we are revising the proposed definition of “food” to exclude pesticides and retain 
“food contact substances” in the definition of “food” in this final rule, consistent with the 
definition of “food” in the final FSVP regulation . 
J.  Food Safety A udit 
We propos ed to define “food safety audit” as a regulatory audit or a consultative audit.  
(Comment  15)  We received a few comments on the definition of “food safety audit.”  
Some comment s request that we remove consulta tive audits from the definition of “food safety 
audit ,” asserting that consultative  audits  should not be subject to the reporting and notification 
requirements associated with “food safety audits.”  Other comment s say we should replace the 55 
term “ food safety audi t” with “ regulatory audit ,” as a ma tter of statutory construction  and sound 
policy.  Finally, some  comment s suggest that we delete the definition of “food safety audit” 
altogether.   
(Response  15)  We are retaining the definition of “food safety audit” as a useful 
definition to describe regulatory and consultative audits that fall under the requirements of this 
rule.  As described in Response 9, we have revised  the definition of “ consultative audit”  to 
clarify that it is an audit conducted in preparation for a regulatory audit under the third -party 
certification program.  A lthough an audit meeting that definition would be  subject to certain 
reporting and notification requirements, there are many types of audits/arrangements that would 
not fall within the definition of “consultative audit ” or “regulatory audit,” and would therefore 
not be subject to the requirements of this rule , including the reporting and notification 
requirements .  Therefore,   including consultative audits in the definition of “food safety audit ” 
will not prevent eligi ble entities from using  accredited  third -party  certification bodies for 
auditing arrangements that fall outside of the scope of this rule and do not trigger the 
requirements of this rule.   To further address comments’ concerns, we are modifying the 
definit ion of “food safety audit” to provide clarification regarding what types of audits/activities 
would fall outside of the scope of this rule .  Specifically, we clarify that a food safety audit must 
be declared by an eligible entity at the time of audit plann ing and must be conducted on an 
unannounced basis  consistent with section s 808(b)(6) and 808(c)(5)(C) of the FD&C Act.  
K.  Foreign C ooperative  
We proposed to define “foreign cooperative” as an entity that aggregates food from 
growers or processors that is intended for export to the United States.  56 
On our own initiative, we are replacing the p hrase “entity that aggregates” with 
“autonomous association of persons, identified as members, who are united through a jointly 
owned enterprise to aggregate” for cla rification purposes.  
(Comment  16)  Some comments suggest that we add a defi nition for “consolidator.”  The 
comments  contrast consolidators with cooperatives and argue  that consolidators act essentially as 
brokers that purchase products from several sources  and the n export the total set to the United 
States.  According to these comments, consolidators do not own or manage the individual sites 
and generally do not have control over or even knowledge of the processing procedures.  
(Response  16)  We agree with t he comment that an entity without a single management 
system that exercises control over the manner in which individual sites meet the applicable food 
safety requirements of the FD&C Act and FDA regulations would not be an eligible entity.   
However, we dis agree that adding a definition of “consolidator” would be helpful  because 
whether an entity is a “consolidator” has no bearing on the requirements of this rule . 
(Comment  17)  Some comment s point out that while the proposed rule indicates a foreign 
cooperative could be an accreditation body or a third -party  certification body , in their countries 
the government is the accreditation body.  Also, in some places the government authorizes 
certai n parties to conduct audit activities and those parties are under the control and supervision 
of the government.  Accordingly, the comment s suggest that we indicate in which countries and 
in which cases a foreign cooperative could be an accreditation body or a third -party  certification 
body .  Other comment s recommend more detail on how cooperatives are defined, and how they 
would conform to FDA requirements for third -party  certification bodies . 
(Response  17)  We currently are not in a position to be able to determine which countries 
or which foreign cooperatives may be adequately qualified to become accredited under the third -57 
party certification program.  We note that section 808 of the FD&C Act expressly allows foreign 
cooperatives to serve as accredited third -party certification bodies if they are adequately 
qualified and independent of the eligible entities they audit or certify under the third -party 
certification program.  Therefore, we are not categorically excluding foreign cooperatives fro m 
the third -party certification program, n or are we making any categorical decisions on whether 
governmental accreditation bodies have conflicts that would preclude them from accrediting 
such foreign cooperatives under the program.  
L.  Regulatory A udit 
We proposed to define a “ regulatory audit” as an audit of an eligible entity to determine 
whether such entity is in compliance with the provisions of the FD&C Act and the results of 
which are used in determining eligibility for food certification under sectio n 801(q) of the FD&C 
Act or facility certification under section 806 of the FD&C Act, and may be used by an importer 
in meeting the requirements for an onsite audit of a foreign supplier under the FSVP program . 
(Comment  18)  Some comment s request that we c larify the definition of “regulatory 
audit.”   
(Response  18)  The comment s requesting clarification failed to mention specific 
characteristic s in the definition  needing clarification  and did not offer suggestions for 
clarification.  Therefore, we decline t o modify the definition  based on these comments .  
However, on our own initiative  we have revised the definition of “ regulatory audit” by removing 
the clause “, and may be used by an importer in meeting the requirements for an onsite audit of a 
foreign supplier under subpart L of this part” that does not appear in the statute.  We did this in 
part to avoid confusion .  We emphasize that an  audit conducted for the purposes of FSVP would 
not need to be conducted by a third -party certification body under this subpart.  See section 58 
XIII.G.   Nor are facilities required to use third -party certification bodies accredited under this 
rule in meeting their supplier verification requirements under the final human or animal 
preventive controls  regulations .  On our own initiative, we are revising the definition of 
“regulatory audit ” to clarify that the results of a regulatory audit may be used to determin e 
eligibility for any certifications that may be used for purposes of section 801(q) or section 806 of 
the FD&C Act.  
M. Self -Assessment  
We proposed to define “self -assessment ” as a systematic assessment conducted by an 
accreditation body or by a third -party certification body to determine whether it meets the 
applicable requirements of this subpart.  
We received no adverse comments about our proposed definition.  However, o n our own 
initiative, we are revising the definition of “self -assessment”  to improve c larity and to specify 
what is required of a recognized accreditation body and an accredited third -party certification 
body  when perform ing these evaluations.  
N.  Third -Party A uditor  
We proposed to define a “ third-party auditor” as a foreign government, agency of a 
foreign government, foreign cooperative, or any other third -party  that is eligible to be considered 
for accreditation to conduct food safety audits and to certify that eligible entities meet the 
applicable requirements of the FD&C Act.  We further proposed that a  third -party auditor may 
be a single individual or an organization  and may  use audit agents to conduct food safety audits.  
Finally, we proposed that “third-party auditor ” has the same meaning  as “certification body ” as 
that term was defined in the proposed rule . 59 
(Comment  19)  As described in Comment 1, w e received several comments urging us to 
align our definitions and terminology with international standards.  Some comment s state that  the 
term “third-party auditor ,” the language of the statute notwithstanding, is not correct terminology 
to use interchangeably with “third -party certification body.”   
(Response  19)  As discussed previously, w e agree that i t is beneficial to use terminology 
in this rule that is consistent with terminology used in international standards when feasible and 
appropriate.  Therefore, we  are deleting the definition of “ third-party auditor” in the final rule 
and will use the term “ third -party certification body” in this rule except that we will use the term 
“third-party auditor” in the definitions of “Accredited third -party certification body” and “Third -
party certification body” in § 1.600(c) and in the preamble discussion of those definitions in 
section III.A .  We are clarifying in t he definition of “third -party certification body” in § 1.600 (c) 
that the term has the same meaning as “ third-party auditor” as defined in section 808(a)(3) of the 
FD&C Act.  
IV. Comments on Who  is Subject  to this Subpart  (§ 1.601)   
We proposed in § 1.601 that this rule would apply to those accreditation bodies, third -
party certification bodies, and eligible entities that seek to participate in this voluntary third -party 
certification  program .  We proposed two limited exemption s from section 801(q) of the FD&C 
Act: one related to alcoholic beverages from an eligible entity that is a facility that meets certain 
conditions, and another related to certain food constituting not more than 5 percent of the overall 
sales of a facility meeting  the conditions of the first exemption.  60 
A.  Limiting the Scope of the Rule to Regulatory Audits and Certifications  
Under proposed § 1.601(b), we proposed that subpart M would apply to third -party 
certification bodies seeking accreditation to conduct food safety audits and issue certifications 
for purposes of sections 801(q) and 80 6 of the FD&C  Act. 
(Comment  20)  Some comment s suggest we modify the language in § 1.601(b) regarding 
third -party certification bodies seeking accreditation to clarify that requir ements of the rule apply 
only to imported foods that are subject to a condition of admissibility under section 801(q) of the 
FD&C Act and imported foods offered by an importer seeking to establish eligibility to 
participate in VQIP.  In this view , the requ irements of the rule (e.g.,  the notification 
requirements) should not apply to audits other than regulatory audits that are conducted for 
certification purposes.  
(Response  20)  We d ecline to make t he suggested revisions to § 1.601 (b) because 
§ 1.601(b)(2) already describes the two types of certifications that may be issued by accredited 
third -party certification bodies under the final rule  and the types of audits that they would 
conduct under this program (i.e., food safety audits, which include  both consultative and 
regulatory audits) .  Audits conducted by third -party certification bodies that are outside of the 
scope of this program, and eligible entities receiving audits outside of the scope of this program, 
would not be subject to the require ments of this final rule.  With respect to the suggestion that 
the final rule should apply only to regulatory audits, and therefore not to consultative audits, we 
note, as previously discussed, that section 808 of the FD&C Act specifically defines 
“consult ative audit ” and contains requirements for the conduct of both regulatory and 
consultative audits (see, e.g., section 808(a)(5)  and (c)(4)(B) of the FD&C Act).  Therefore, this 61 
final rule establishes requirements for consultative audits that are consistent  with the provisions 
on consultative audits in the statute .  
B.  Exemption for Alcoholic Beverages   
Under proposed §  1.601(d), we proposed to exempt from the certification requirements 
under section 801(q) of the FD&C Act alcoholic beverages that are imported from an eligible 
entity that is a facility that meets the following two conditions:  
•     Under the Federal Alcohol Administration Act or chapter 51 of subtitle E of the Internal 
Revenue Code of 1986, the facility is a foreign facility of a type t hat, if it were a domestic 
facility, would require obtaining a permit from, registering with, or obtaining approval of 
a notice or application from the Secretary of the Treasury as a condition of doing 
business in the United States; and  
•     Under section  415 of the Federal Food, Drug, and Cosmetic Act, the facility is required 
to register as a facility because it is engaged in manufacturing/processing one or more 
alcoholic beverages.  
We also proposed that the certification requirements under section 801(q ) of the FD&C 
Act would not apply to food other than alcoholic beverages that is imported from a facility 
described in § 1.601(d)(1) provided that such food:  
(i)  Is in prepackaged form that prevents any direct human contact with such food; and  
(ii)  Const itutes not more than 5 percent of the overall sales of the facility, as determined 
by the Secretary of the Treasury.  
We tentatively concluded that these provisions were consistent with the provisions on 
alcohol -related facilities in section 116 of FSMA.   62 
(Comment  21)  Some comment s support the proposed exemption of imported beverage 
alcohol products, but encourage us to clarify and amplify the exemption  to cover the raw 
materials and ingredients (e.g., grapes, grains, hops, flavors) used to produce alcohol ic 
beverages.  The comment s assert that the requested e xemption would provide for consistency 
between domestic and foreign facilities and would be consistent with Congressional intent 
regarding section 116 of FSMA.   The comment s assert  that the expanded ex emption would be 
consistent with the regulations on preventive controls for human food .  The comment s urge us to 
consult their comments on the FSVP proposed rule.   
(Response  21)  As requested, we  consulted comments submitted on proposed § 1.501(e) 
in the FSVP proposed rule, requesting an exempt ion from the FSVP requirements for the 
importation of the raw materials and ingredients (e.g., grapes, grains, hops, flavors) used to 
produce alcoholic beve rages , and asserting that such an exemption would be consistent with 
Congressional intent regarding section 116 of FSMA.   
We considered the comment s’ request in light of the risk-based public health principles 
generally underlying FSMA  and have concluded that Congress did not intend for FSMA’s core 
requirements to apply to the manufacture/processing, packing, and holding of alcoholic 
beverages.  Congress may have made such a conclusion in light of the potential antimicrobial 
function of the alcohol content  in such beverages and the concurrent regulation of alcoholic 
beverage -related facilities by both FDA and the Alcohol and Tobacco Tax and Trade Bureau.  In 
light of this context, we have  concluded that section 116 of FSMA should be interpreted to mean  
that the manufacturing, processing, packing, or holding of alcoholic beverages at most alcohol -
related facilities should not be subject to th is rule .   63 
We believe the same rationale supports the comment s’ request.  Accordingly, and 
consistent with the final FSVP regulation , we are expanding the exemption from certification 
under section 801(q) of the FD&C Act in § 1.601(d) to cover raw materials or other ingredients 
that are used to manufacture/process , pack or hold  alcoholic beverages by an  importer required 
to be registered under section 415 of the FD&C Act, when such facilities are exempt from the 
preventive controls regulations under 21 CFR  117.5(i) .   
Also in this final rule, we are replacing the term “ food other than alcoholic beverages ,” to 
describe the applicability of the exemption , with the term “food that is not an alcoholic 
beverage.”  
C.  USDA Regulated Products  
(Comment  22)  Some comment s suggest we explicitly exempt products under USDA 
jurisdiction from the requirements of this ru le.   
(Response  22)  We agree that an exemption to 801(q) is appropriate with respect to meat, 
poultry, and egg products regulated by USDA at the time of importation.  The final rule adds a 
new § 1.601(d)(2) which states that any certification under 801(q)  does not apply to meat, 
poultry, and egg products that at the time of importation are subject to the requirements of the 
USDA under FMIA (21 U.S.C. 601 et seq .), PPIA (21 U.S.C. 451 et seq .), or EPIA (21 U.S.C. 
1031 et seq .).  We conclude that this provis ion is consistent with section 403 of FSMA, entitled 
“Rule of Construction,” which states that nothing in FSMA shall be construed to alter or limit the 
jurisdiction of the Secretary of the Department of Agriculture.  For many decades, USDA has 
exercised au thority and responsibility over the import of such meat, poultry, and egg products, 
and has detailed regulations and procedures implementing this authority.  In light of USDA’s 
role with respect to the importation of these products, and also in light of se ction 403 of FSMA, 64 
we believe that Congress did not intend for an FDA determination under section 801(q)  of the 
FD&C Act  to apply to meat, poultry, and egg products that at the time of importation are subject  
to USDA requirements under the MPIA, PPIA, and EPIA, respectively.  We therefore conclude 
that final § 1.601(d)(2) is consistent with Congress’s intent in promulgating section 403 of 
FSMA.   
With respect to the third -party  program, we note that the progra m establishes a voluntary 
system of certification by accredited third -party certification bodies  that food and facilities meet 
applicable requirements of the FD&C Act and FDA regulations.  Certifications issued under this 
program will not be used to facili tate entry of meat, poultry, and egg products that are regulated 
by USDA at the time of importation, as defined above.   
V. Comments on Recognition of Accreditation Bodies Under this Subpart  
A.  Who Is Eligible to Seek Recognition?  (§ 1.610 ) 
Proposed § 1.61 0 state s that an accreditation body would be eligible for recognition if it 
could demonstrate that it meets the requirements related to legal authority, competency, capacity, 
conflicts of interest, quality assurance, and records in §§ 1.611 through 1.615.  In our discussion 
of this section in the preamble of the proposed rule we stated our tentative conclusions that key 
elements of ISO/IEC 17011:2004 (Ref. 5) would form a basis for our requirements, and that 
documented conformance to that standard would be relevant in demonstrating that an 
accreditation body is qualified for recognition.   
(Comment  23)  Some comment s recommend that we require accreditation bodies to be 
signatories to IAF multilateral recognition agreements (IAF -MLAs) (which requires signatories, 
among other things, to conform to ISO/IEC 17011:2004)  as a condition of recognition , and  some 
contend it should be the sole criterion.  Comment s in favor of including signatory status as a 65 
requirement note that the process of becoming a signatory involves a thorough peer -review 
process , which helps  ensure quality outcomes (e.g ., signatories have to  demonstrat e conformance 
to ISO/IEC 17011 :2004  as part of the peer review process).  Comment s note other aspects of 
IAF-MLA signatory status th at would be beneficial to the program, such as periodic reevaluation 
by peer signatories t o ensure continued compliance. These comment s argue that when a foreign 
government is the accreditation body, it may be difficult for FDA to regulate a peer agency, s o 
reliance on IAF -MLA signatory status would be helpful, in part because it would give an 
independent organization (IAF) a role in managing the accreditation body.  
Some comment s discourage us from requiring IAF -MLA signatory status as a condition 
of recogn ition.  Some comment s suggest that we consider signatory status as a factor in favor of 
recognition, noting many of the same advantages touted by proponents of requiring signatory 
status , but suggest that we not mak e IAF -MLA signatory status a condition of  program 
particip ation.  
Other comment s explain that it would be premature to make IAF signatory status the sole  
requirement . The comments note that at the time of these comments the IAF -MLA does not yet 
include subscopes for specific food safety standards or schemes.  Still other comment s 
recommend that FDA study the issues surrounding signatory status further before making it a 
requirement, pointing out that some countries may not have signa tory IAF -MLA members 
representing them .   
Some comment s cite to third -party food safety audit programs administered by other 
governments, noting those programs d o not require IAF-MLA status  as a condition for program 
participation .  These comment s argue th at it is more important to require conformance to 
ISO/IEC 17011 :2004 . 66 
(Response  23)  The comments uniformly agree on the value of an accreditation body’s 
conformance to ISO/IEC 17011:2004  in establishing its qualifications for recognition.  As 
discussed in section I.D. , we agree that an accreditation body may use its documented 
conformance to ISO/IEC 17011:2004 to support its eligibility for recognition under this rule , 
supplemented as necessary  (for example, to demonstrate capability to meet  FDA requirements 
for reporting and notification under § 1.623, if recognized) .  We also agree that additional 
documentation relating to IAF -MLA signatory status may be use ful in support ing an 
accreditation body’s application for recognition under this pro gram .  However, w e disagree with 
comment s suggesting th at we require IAF -MLA signatory status as the sole criterion or one of 
several criteria for recognition to accredit third -party certification bodies to conduct food safety 
audits and to certify that el igible entities meet the applicable food safety requirements of the 
FD&C Act and FDA regulations at this time .  We currently lack (and the comments did not 
provide) adequate  information to conclude that IAF -MLA signatory status should be the sole 
factual b asis or one of several criteria for determining whether an accreditation body can fulfill 
the roles and responsibilities of a recognized accreditation body  under this subpart.   Further, we 
also want to allow accreditation bodies  that are not signatories to participate in the program if 
they meet the statutory and regulatory criteria.   
(Comment  24)  As explained in section I.D., s everal comment s support  FDA’s reliance 
on ISO/IEC 17011:2004 (Ref. 5) in developing the proposed rule .  Other comments suggest FDA 
should place greater reliance on ISO/IEC 17011:2004 (Ref. 5), including some comments 
recommending that we incorporate the standard by reference into the rule.  
(Response  24)  We agree with comment s on the value of promoting international 
consistency and tapping into an existing framework that is familiar to accreditation bodies, third -67 
party certification bodies, and the food industry.  Accordingly, in § 1.610 we are adding new 
language to state that an accreditation  body may use documentation of conformance with 
ISO/IEC 17011:2004  (Ref. 5), supplemented as necessary, to demonstrate that it is eligible for 
recognition.   This new language may make it easier for accreditation bodies that already conform 
to ISO/IEC 17011 :2004 (Ref. 5) to apply for the program .  We are also making conforming 
changes to § § 1.622(d) and 1.623(b) , 1.640(a), and 1.655(e).  
We decline to incorporate ISO/IEC 17011:2004 (Ref. 5) by reference as the sole criterion 
or one of several criteria for recognition , because the standard contains some provisions that are 
inconsistent with section 808 of the FD&C Act or impractical  for use in our program.   For 
example, ISO/IEC 17011:2004 (Ref. 5), clause 4.3. 7, allows an accreditation bod y to have 
“related bodies ” that provide conformity assessment services (e.g., auditing and certification) in 
areas the accreditation body accredits .  (A “related body” is linked to the accreditation body by 
common ownership or contractual arrangement , under clause 4.3.7 NOTE  1.)  The only 
safeguards that a related body is expressly required to meet are as follows:  (1) It must have  
different top management  than the accreditation body’s top management; (2) different personnel 
from those involved in the accreditation decisionmaking  processes ; (3) no possibility to influence 
the outcome of an assessment for accreditation; and (4) distinctly different names, logos, and 
symbols.  While clause 4.3.7 of ISO/IEC 17011 (Ref. 5) speaks to issues of common 
management and contro l of the accreditation body and its related body, the standard does not 
expressly prohibit the accreditation body from accrediting its related body  with which it shares 
common ownership or financial interests .  For example, an accreditation body that provi des 
financial support (directly or indirectly ) to a related body could be viewed  as lacking the 
impartiality necessary to make an objective decision about whether the related body it supports is 68 
appropriately qualified .  The impartiality provisions in ISO /IEC 17011:2004 (Ref. 5) are 
impractical for our purposes because they fail to address the range of possible conflicts 
associated with shared financial interests and ownership between a recognized accreditation 
body and a “related” third -party certification body  under this rule .  To help ensure the credibility 
of our program , § 1.624 requires a recognized accreditation bod y to implement a program to 
ensure that the accreditation body and its officers, employees , and other agents involved in 
accreditation activities do not own  or have a financial interest in  a third -party certification body 
seeking its accreditation .  Accordingly, i t would be inappropriate for us to rely on the c onflict of 
interest safeguards contained in ISO/IEC 17011:2004 (Ref. 5), in the third -party certification 
program we are establishing .   
For the foregoing reasons, we decline the suggestion to incorporate ISO/IEC 17011:2004 
(Ref. 5) by reference into this rule.    
(Comment  25)  Several comment s express concern about our proposal to allow both 
public and private accreditation bodies to seek recognition.  Some comment s discourage us from 
allowing private entities to be accreditation bodies be cause of the concern that allowing for 
private accredit ation bodies may cause conflicts of interest.  Similarly, some comment s contend 
that accreditation bodies must uphold public confidence and perform their duties objectively, 
which is the purview of governmental entities.   
Other comment s take a contrary vi ew, suggesting that some government agencies have 
missions that may undermine the objectivity and independence required of a recognized 
accreditation body.  Some comment s encourage us to consider which government 
agency/ministry in a given country may be e ligible for recognition, and to solicit input from 
stakeholders as to which agencies/ministries are best positioned to perform this function.   69 
Still other comments assert  that private and government entities are sufficiently different 
such that we should establish different conflict of interest provisions and requirements for each .   
(Response  25)  Comments on both sides of this issue express concern that any 
accreditation body we recognize must be independent and objective in the performance of its 
duties .  We share that concern.  However, none of the comments offered substantiation that 
would lead us to bar public or private accreditation bodies, as a class, from seeking recognition 
because of conflicts of interest inherent in the class . 
Section 808 of the FD&C Act defines an “accreditation body” as an authority that 
accredits third -party certification bodies and makes no distinction between public and private 
accreditation bodies.  We have concluded that both public and private accreditation bodi es are 
potentially capable of exhibiting the impartiality necessary for recognition under this rule.  
Therefore i n light of the broad definition of “accreditation body” and to maximize the 
opportunities for qualified accreditation bodies to participate in the program, FDA does not 
consider it to be appropriate to limit the program to only certain types of accreditation bodies.  
With respect to the comments that suggest we apply different conflict of interest 
requirements to different types of accreditation b odies, none of these comments offered an 
adequate explanation to justify different requirements for public and private accreditation bodies.  
Again , we note that section 808 of the FD&C Act do es not make distinctions for different types 
of accreditation bo dies.   
(Comment  26)  Some comment s request that we provide additional explanation regarding 
how an accreditation body that does not have experience accrediting third -party certification 
bodies for food safety scopes would become eligible for recognition u nder this program.  70 
(Response  26)  An accreditation body of the type described in the comment s’ 
hypothetical might face practical difficulties in providing adequate substantiation demonstrating 
that it meets the requirements described in § 1.610.  However, we will consider each application 
on its own merits and do not foreclose the possibility for such an accreditation body to make the 
showing necessary to be granted recognition under this rule.   
B.  What Legal Authority Must an Accreditation Body Have to Qualify for Recognition ? 
(§ 1.611)  
We proposed to require a n accreditation body seeking recognition to demonstrate that it 
has adequate legal authority (as a governmental entity or through contractual rights) to assess a 
third -party certification body for accreditation, including authority to review records and conduct 
performance assessments (e.g. , authority to witness the performance of a statistically significant 
number of employees  and other agents conducting assessments).  We proposed to require that t he 
accreditation body have adequate authority to remove or modify an accreditation status, once 
granted.  We also proposed to require the accreditation body to demonstrate that it would be 
capable of exercising the legal authority necessary to meet the pro gram requirements, if we 
granted recognition.   
On our own initiative, in § 1.611(a)(2) we replaced, “personnel and other agents,” with, 
“audit agents, or the third -party certification body in the case of a third -party certification body 
that is an individual” for clarity  and consistency with section 808(a)(4)  of the FD&C Act .  We 
have also made corresponding changes throughout this subpart.   
(Comment  27)  Some comments provide support for this provision, and others encourage 
us to ensure that a private accreditation body seeking recognition could have adequate legal 
authority to operate.  71 
(Response  27)  We agree with the comment urging us to ensure that a private 
accreditation body could have the necessary authority to act as a recognized accreditatio n body 
under this rule.  As noted previously, we see no inherent reason  why private entitie s could not 
theoretically meet the eligibility requirements for accreditation bodies under this rule.  Therefore, 
we are revising  § 1.611(a)  and (b) to clarify that an accreditation body can be a legal entity with 
contractual rights .  By the words “legal entity,” we mean that the accreditation body must be 
duly authorized to operate as an accreditation body by governmental authorities responsible for 
such authorizatio ns in any country or countries in which the accreditation body seeks to perform 
accreditation of third -party certification bodies under this rule.   
(Comment  28)  Some comments ask us to clarify what we mean by “statistically 
significant” as used in § 1.61 1(a)(2) and elsewhere in the proposed rule  to provide  adequate 
confidence in the results  of an analysis of the sample .  The comments encourage us to abandon 
the phrase “statistically significant” in favor of the language of ISO/IEC 17011 :2004  (Ref. 5) , 
which requires an accreditation body to witness the performance of a representative number of 
third -party certification body staff.   
(Response  28)  We understand from the comment s that a body of knowledge and 
experience has developed among accreditation bodi es conforming to ISO/IEC 17011: 2004 (Ref. 
5) on the meaning of “representative” numbers of observations and that no similar body of 
knowledge or experience exists on the meaning of “statistically significant” numbers of 
observations  in this context .  Accordingly, we are revising § 1.611 to require observations of a 
“representative sample” of audit agents and food safety audits.  We are making similar revisions 
to other sections of the rule that require onsite observations.  72 
For purposes of an accredi tation body’s observations of a third -party certification body 
under this rule, what constitutes a “representative sample” will be decided on a case -by-case 
basis, depending on various factors .  These factors include  the scope of accreditation, whether 
the third -party certification body is an individual who will conduct audits and make certification 
decisions, or whether the third -party certification body uses agents to conduct audits and, if so, 
whether such agents are centrally managed, conducting similar  types of audits, under a single set 
of operating procedures or whether the agents are managed from various locations, perform 
different types of audits, or follow different procedures such that these various locations, 
activities, or practices must be obs erved to ensure that the sample is sufficiently representative .  
A representative sample also must provide adequate confidence in the results of an analysis of 
the sample .    
C.  What Competency  and Capacity Must an Accreditation Body Have to Qualify  for 
Recognition ? (§ 1.612)  
We proposed to require an accreditation body seeking recognition to demonstrate that it 
has the resources required to adequately implement its accreditation program, including adequate 
numbers of qualified employees  and other  agents, adequate financial resources for its operations, 
and the capability to meet the resource demands of a recognized accreditation body, in the event 
the accreditation body is recognized.  
(Comment  29)  We received some comments on this provision,  which also support  the 
proposed rule ’s requir ement that  accreditation bodies demonstrate their competence and capacity 
based on the requirements of ISO/IEC 17011 :2004  (Ref. 5) .  However, these comment s disagree 
with our statement in the preamble that liability coverage requirements should not apply to this 
rule.  The comment s argue that we should include a requirement for accreditation bodies to carry 73 
liability coverage, noting that it is one of the requirements in ISO/IEC 17011 :2004  (Ref. 5) and 
describing it as especially important because of the risks associated with food safety.  
(Response  29)  We agree with the comment s that liability insurance may be useful in 
demonstrating the adequacy of an accreditation body’s resources , for example, under ISO/IEC 
17011:2004 (Ref.  5); however, FDA lacks experience in evaluating the adequacy of liability 
coverage for accreditation activities  and w e do not believe it would be appropriate for FDA to 
make recognition decisions primarily on this basis .  We believ e an accreditation body can 
demonstrate that it is adequately resourced in a number of different ways, including providing 
docu mentation of liability coverage as part of the information submitted to help to demonstrate 
that accreditation body is adequately  resourced.   
D.  What Protections Against Conflict of Interest Must an Accreditation Body Have to Qualify 
for Recognition? ( § 1.613 ) 
Proposed § 1.613 requires accreditation bodies to  demonstrate that they  have written 
measures to protect against conflicts of interest with third -party certification bodies and the 
capability to meet the rule’s other conflict of interest requirements.   
On our own initiative, we are clarifying that the scope of conflict of int erest provisions in 
§ 1.613(a) is limited to individuals involved in accreditation, auditing, and certification activities 
and not, for example, employees  involved in purely administrative functions , such as payroll , or 
in positions that support administra tive functions, such as computer technicians.  Therefore, 
§ 1.613(a) of this rule applies to interests between the officers, employees , and other agents of 
the accreditation body that are involved in accreditation activities and the officers, employees , 
and other agents of the third -party certification body involved in auditing and certification 74 
activities .  We are making corresponding changes in the subsequent provisions for recognized 
accreditation bodies under §  1.624(a).  
(Comment  30) Some comment s take issue with our decision not to include the 
requirements of clause 4.3.2 of  ISO/IEC 17011:2004 (Ref. 5), which requires the accreditation 
body to have documented and implemented a structure relating to conflicts of interest that  
provide s for effective involvement by interested parties with balanced representation ensured .   
(Response  30)  We decline to  require that recognized accreditation bodies establish and 
implement a structure for involv ing interested parties in matters relating to the conflict of interest 
requirements for recognized accreditation bodies.   It would be administratively burdensome for 
FDA to establish  a mechanism for monitoring the activities of interested parties that the 
accreditation body  elects to involve to comply wit h such requirements .  In our third -party 
certification program, impartiality will be protected by t he conflict of interest provisions for 
accreditation bodies in § 1.624, the appeals provisions in §1.620(d) , and FDA’s oversight 
activities . 
E.  What Quality  Assurance Procedures Must an Accreditation Body Have to Qualify for 
Recognition? (§ 1.61 4) 
Proposed § 1.614 requires accreditation bodies to implement a written quality assurance 
program and have the capability to meet the rule’s other quality assurance r equirements.  
(Comment  31) Some comment s encourage FDA to more closely align § 1.614 with 
established international standards  on quality assurance programs .  Some ask us to rely on the 
relevant provisions in ISO/IEC 17011 :2004  (Ref. 5)  in particula r. 75 
(Response  31)  We agree with the comment s and as described in section I.D., we  are 
revising § 1.610 to allow accreditation bodies to use their demonstrated conformance to ISO/IEC 
17011:2004 (Ref. 5), supplemented as necessary,  in meeting the requirements f or recognition.  
(Comment  32)  Some comment s ask us to clarify the language in § 1.614(a)(1) and (2) 
regarding food safety problems and corrective actions.   
(Response  32)  We agree and have revised § 1.614(a)(1) and (2) to clarify that an 
accreditation bod y must demonstrate that it has procedures to identify deficiencies and 
procedures to execute corrective actions for such deficiencies, using language that  better align s 
with international standards  (see, e.g. , clause 5.5 in ISO/IEC 17011:2004 (Ref. 5)). 
F.  What Records Procedures Must an Accreditation Body Have to Qualify for Recognition? 
(§ 1.615)  
Proposed § 1.615 would require accreditation bodies seeking recognition to demonstrate 
that they have developed and implemented adequate written procedures for establishing, 
controlling, and retaining records and to demonstrate the capability to meet the p rogram’s 
records, reporting, and notification requirements, if recognized.  
(Comment  33)  Some comment s voice general concerns about confidentiality.  Others 
state their concern with how confidentiality of third -party certification body records would be 
preserved when third -party certification bodies must share information with recognized 
accreditation bodies and FDA.  Noting that such information can be sensitive in nature and 
sometimes includes confidential business information, these comment s urge us to place certain 
limits --i.e., only information related to food safety would be collected during audits of third -
party certification bodies and such information would be shared only with the recognized 
accreditation body and FDA.  Some comments suggest FDA re quire strict protective measures 76 
for information handled by third -party certification bodies and accreditation bodies, because the 
release of an eligible entity’s confidential business information could have detrimental effects on 
U.S. businesses and their  foreign suppliers.  These comments suggest the use of confidentiality 
protections such as “confidential disclosure agreements” so that the audit climate remains 
conducive to robust scrutiny and open dialogue.  
Some comment s also express concern with the pr oposed use of electronic records, 
because of the opportunity for sensitive electronic information to be compromised.  Such 
comment s recommend that the final rule include requirements for both  third -party  certification 
bodies and accreditation bodies to ens ure that electronic records remain secure in transit and 
during storage.   
(Response  33)  We decline the suggestions to require confidential disclosure agreements 
between recognized accreditation bodies and third -party certification bodies under our program  
and to establish data protection requirements for electronic records and communications of 
recognized accreditation bodies and accredited third -party certification bodies.  We understand 
that many accreditation bodies and third -party certification bodies have contractual agreements 
regarding confidentiality and disclosure by those parties.  We expect accreditation bodies that 
become recognized under our program may elect to establish contracts that incorporate language 
on information sharing with FDA for t hird-party certification bodies seeking accreditation under 
this program.  For such accreditation bodies, how they choose to accomplish  this--e.g., whether 
by establishing a separate confidentiality agreement or through revision of current contract 
languag e or creation of a new contract addendum --is a decision best made by the parties to those 
contracts.  Accreditation bodies and third -party certification bodies will have common interests 
in safeguarding the electronic records they store and transmit to eac h other; therefore, we have 77 
no reason to believe that any separate agreements will lack adequate protections for 
confidentiality of information, including information stored and shared among the parties 
electronically.  
This rule focuses on confidentiality  and disclosure with respect to information shared 
with FDA.  As explained in section XIII.F., FDA will protect the confidentiality of information 
accessed by or submitted to the Agency in accordance with § 1.695 of this subpart.  With respect 
to the storage of electronic records and electronic transmission of inform ation by FDA, we note 
that we are working the FDA IT security professionals in establishing the electronic portal for 
the third -party certification program to apply adequate and appropriate controls to ensure the 
confidentiality and integrity of data submi tted to FDA through the portal.   
(Comment  34)  In the proposed rule preamble discussion of this section we stated that, 
“[a]ccreditation bodies applying for recognition must demonstrate their capacity, if recognized, 
to grant us access to confidential info rmation, including information contained in records, 
without prior written consent of the  third -party  certification body involved.  Having access to 
records relating to accreditation activities (including confidential information) under this subpart 
is nec essary to ensure the rigor, credibility, and independence of the program.”  Some comment s 
take issue with this point, arguing that accreditation bodies would not be able to grant such 
access --they would only be able to grant access to confidential informat ion with prior written 
consent.  That is, the accreditation body would first need to make arrangements for FDA access 
to confidential records with the third -party certification bodies it accredits and the eligible 
entities certified by those third -party certification bodies.  Comment s that express doubt about 
private sector foreign accreditation bodies actually granting FDA access to confidential records 78 
contend that such access is particularly unlikely without the prior written consent of the third -
party certification body whose records are sought.  
(Response 34)  We agree with the comment s that the contracts accreditation bodies 
currently use with their third -party certification body clients do not contemplate the program we 
are establishing.  As comment s suggest, we would expect that confidentiality provisions in 
standard contracts would need to be revised such that, in signing a contract for accreditation 
under the FDA program, the third -party certification body would be giving the accreditation 
body its prior consent to perform any reporting or notification necessary for the recognized 
accreditation body to fulfill its obligations under the rule.  Indeed, we expect that accreditation 
bodies seeking recognition will demonstrate their ability to comply with  the reporting and 
notification provisions of this rule by providing us examples of standard contract language that 
has been suitably revised as comment s describe.   
VI. Comments on Requirements for Recognized Accreditation Bodies Under this Subpart  
A.  Ho w Must a Recognized Accreditation Body Evaluate Third -Party Certification Bodies 
Seeking Accreditation? (§ 1.620)  
Proposed § 1.620 would establish the criteria and procedures  that a recognized 
accreditation body must use in assessing third -party certificat ion bodies for accreditation.  
Paragraph (a) broadly addresses the different requirements for foreign governments and foreign 
cooperatives  or other third parties .  Paragraph (b) requires the accreditation body to require third -
party certification bodies to  satisfy the rule’s reporting and notification requirements.  Paragraph 
(c) requires the accreditation body to maintain certain records, such as those related to 
withdrawal or suspension of a third -party certification body.  Paragraph (d) requires an 79 
accre ditation body to have written procedures for handling appeals from third -party certification 
bodies, and requires cert ain minimal appeal procedures.  
On our own initiative, we are revising § 1.620(a)(2) and (3) to apply to accredited third -
party certificat ion bodies that are comprised of a single individual, as applicable.   We are also 
removing, “and any requirements specified in FDA model accreditation standards regarding 
qualifications for accreditation, including legal authority, competency, capacity, conflicts of 
interest, quality assurance, and records” to follow good guidance practice.  We are making 
corresponding changes to §§ 1.620(a)( 1), 1.640(b), and 1.640(c).   We are also revising 
§ 1.620(c) to specify that recognized accreditation bodies must also include the date of the action 
in their records relating to any de nial of accreditation or the withdrawal, suspension, or reduction 
in scope of accreditation of a third -party certification body.   In addition, we are revising § 
1.620(d) to clarify that the recognized accreditation body must notify any third -party certific ation 
body of an adverse decision associated with its accreditation under the subpart, including denial 
of accreditation or the withdrawal, suspension, or reduction in the scope of its accreditation.  
(Comment  35)  In paragraph (a)(3) of this proposed secti on we stated that a recognized 
accreditation body must observe “a statistically significant number of onsi te audits” conducted 
by the third -party certification body seeking accreditation.  Some comment s request clarification 
of what we meant by “statistica lly significant,” so that accreditation bodies would know what 
would be  an adequate  number of audits to observe  to provide adequate confidence in the results  
of an analysis of such observations .  The comments suggest that we should explain the criteria 
for determining t he number of witness audits to be conducted  under proposed §  1.620 and as k 
whether site -specific issues such as geographic factors  should be considered .  Other  comment s 
encourage us to abandon the phrase “statistically significant” in favor o f the language of 80 
ISO/IEC 17011 :2004  (Ref. 5) , which requires an accreditation body to witness the performance 
of a representative number of third -party certification body staff.    
(Response  35)  We have removed the phrase  “statistically significant” in § 1.620(a)(3) 
and inserted the phrase “representative sample .”  We explain  in Response 28 that comment s 
presented compelling arguments that a significant body of knowledge and experience has 
developed around the meaning of a “representative” number of observations under ISO/IEC 
17011:2004 (Ref . 5) to achieve an adequate level of confidence in the results.   We have revised § 
1.620(a)(3) accordingly.   Site-specific issues may be relevant in determining the representative 
number of witness assessment s to conduct , for example, where audit agents are located in remote 
offices or where food safety audits are managed by remote offices.  The accrediting body, either 
a recognized accreditation body or FDA in the case of direct accreditation, will be best 
position ed to determine whether geographic  issues are relevant for purposes of § 1.620(a)(3).  
(Comment  36)  Some comment s ask us to revise § 1.620(d)(2) to clarify that the 
individuals used to hear appeals of adverse decisions by a recognized accreditation body co uld 
be individuals external to the accreditation body.  
(Response  36)  We agree with the comment s and have revised this provision  to clarify 
that individuals used to hear appeals may be external to the accreditation body , as well as a 
similar provision app lying to appeals by eligible entities of adverse decisions by an accredited 
third -party certification body.   We have also revised this provision to use  language similar to 
language that is used in § 16.42(b) , which describes the characteristics of a presiding officer that 
may be used for FDA regulatory hearings.    
(Comment  37)  In the preamble to the proposed rule we stated that we were not proposing 
to review the decisions of recognized accreditation bodies nor were we proposing to hear appeals 81 
from  third -party certification bodies aggrieved by an accreditation body’s decision(s). We sought 
comment on these matters.  In response, some comment s state their understanding that FDA 
would retain the authority to challenge a recognized accreditation body’s  decisions, because we 
have authority over the entire program.   
(Response  37)  We agree with comment s that our oversight extends to any accreditation 
body or third -party certification body participating in the program, including the authority to 
withdraw accreditation from a third -party certification body even if the accreditation was granted 
by a recognized accreditation body.  However, FDA does not intend to serve as an appellate 
body for aggrieved third -party certification bodies , as this would be unwor kable  and 
unnecessary .  Withdrawing the accreditation of a third -party certification body to remove it from 
our program is quite different than, for example, overturning an accreditation body’s decision to 
deny accreditation to a third -party certification body  in the first place .  Our program is designed 
to ensure the competency and independence of accreditation bodies.  As part of this program, 
FDA will be recognizing accreditation bodies to make accreditation decisions based on a 
determination that the ac creditation body is qualified to do so.  FDA involvement in 
accreditation decisions would defeat the purpose of the program.  Additionally, FDA retains the 
authority to revoke the recognition of accreditation bodies for good cause under § 1.634(a)(4)  for 
failure to comply with this rule .  For all of these reasons , FDA declines to codify a process to 
review appeals challenging recognized accreditation body decisions under this program.  
(Comment  38)  Several comments encourage us to expand on the requirement  to use 
“independent” person(s) to hear an appeal of an adverse accreditation body decision.  Some 
comments suggest that we clarify that an independent person is one who was not involved in the 82 
decision that is the subject of the appeal.  A few comments su ggest we further require the 
accreditation body to use person(s) who are external to the organization.  
(Response  38)  We agree with the suggestions to clarify § 1.620(d)(2) and are revising it 
to align with the impartiality provisions in 21 CFR part 16, wh ich contains the regulations for 
regulatory hearings that we will generally apply under § 1.693 to an appeal of a revocation or 
withdrawal.  Under the part 16 regulations, the person presiding over the hearing must be free 
from bias or prejudice and must not have participated in the action that is the subject of the 
hearing or be subordinate to a person who participated in the action.  We believe that the 
credibility of the third -party certification program will be enhanced by requiring recognized 
accredita tion bodies to afford similar protections when considering appeals by certification 
bodies under this rule.  While we decline the suggestion to require the use of external parties in 
deciding appeals, we note that a recognized accreditation body has flexib ility to use an external 
party under § 1.620(d)(2).  
B.  How Must a Recognized Accreditation Body Monitor the Performance of Third -Party 
Certification Bodies It Accredited ? (§ 1.621)  
We proposed to require a recognized accreditation body to conduct an annu al evaluation 
of each of its accredited certification bodies that includes a review of the certification body’s 
self-assessments, its regulatory audit reports, notifications to FDA, and any other information 
reasonably available.  We requested comment on w hether the information we proposed to require 
would provide a solid basis for an evaluation.  We asked stakeholders whether we should include 
a requirement in § 1.621 for onsite monitoring of accredited certification bodies and, if so, 
whether we should re quire the accreditation body to observe or visit the cer tification body’s 
headquarters.  83 
(Comment  39)  We received several comments on the annual assessment requirements of 
proposed § 1.621.  Some comments agree with the requirement for an annual assessment.  Some 
comments mention a Government Accountability Office ( GAO) report  entitled, “FDA Can 
Better O versee Food Imports by Assessing and Leveraging Other Countries’ Oversight 
Resources” (GAO 12 -933) and dated September 2012,  which notes ongoing challenges with 
ensuring the competency of third parties to consistently apply standards and argue s that annual 
assessments would improve certification body reliability and competency.  Some of these 
comments state they would even support more frequent certification body evaluations.  
In contrast, some comments argue that annual assessment s would be burd ensome.  
Comments variously focus on the burden on accreditation bodies, certification bodies, and 
eligible entities.  Some comments disapprove of the cumulative burden of all the assessments 
(e.g., self -assessments and monitoring assessments) required thr oughout the rule.  Some 
comments suggest biennial assessments, and note that such a requirement would be consistent 
with ISO/IEC 17011:2004 (Ref . 5).  Still others argue that when the accreditation body or 
certification body is a government entity we shoul d allow for flexibility around the timing of 
assessments.  
(Response  39)  We agree with comments that express the view that annual assessments of 
certification bodies will help build confidence in the third -party certification program.  Annual 
assessments will help accreditation bodies ensure certification bodies’ continued compliance 
with the program requirements and quickly identify and address any deficiencies with a 
certification body before a situation escalates.   
We also acknowledge the concerns abou t the efforts needed to comply with the 
monitoring and self -assessment requirements of the rule.  Section 1.621 is part of a set of 84 
proposed monitoring and self -assessment requirements intended to work together in helping to 
ensure that the recognized accr editation bodies and accredited third -party certification bodies 
maintain compliance with the rule’s requirements.  The certification body self -assessment in 
§ 1.655 is intended to serve, in part, as information  for use in the accreditation body monitoring  
in § 1.621, the results of which we intend the accreditation body to use in its self -assessment 
under § 1.622.  We do not intend for the assessments to require duplicative efforts, with each 
section requiring a discrete set of activities with no opportuni ty to use the results of one set of 
activities when performing another.  As explained in the preamble to the proposed rule, the 
accreditation body assessments of certification bodies will not only help ensure that the 
certification bodies continue to compl y with our requirements, but also can help the accreditation 
body identify trends and any deficiencies in its own performance.  The proposed monitoring and 
self-assessment activities are an essential part of the program’s safety net.   
With respect to § 1. 621, in particular, we believe this section will be far less burdensome 
in practice than some of the comments anticipate, because of the convergence between the 
ISO/IEC standards and this rule.  The activities required by § 1.621 are similar in substance t o 
surveillance activities under ISO/IEC 17011:2004 (Ref.  5), which includes review of audit 
reports, results of internal quality control, and management review records  identified in clause 
3.18 NOTE , and thus are likely to be activities many accreditation bodie s already perform.  In 
light of the foregoing, we have concluded that requiring accreditation bodies to perform annual 
evaluations  of each certification body they accredit  under the program is not unduly burdensome.  
We disagree with comments suggesti ng that monitoring should be more frequent than once a 
year, because requiring assessments to be performed and reported twice each year, for example, 
would result in a nearly continuous cycle of assessments and report s.  Semiannual assessments 85 
are likely t o produce limited data sets that would be less helpful for evaluation purposes than 
would larger data sets , such as compilations of 12 months of data, which allow f or tracking and 
trending performance over time.  Requiring assessments to be performed more frequently than 
once a year also risks creating significant disruption of  the operations of accredited third -party 
certification bodies and eligible entities  and might have the unintended effect of serving as a 
disincentive to participation  in the program .  For these reasons, we have determined that  an 
annual monitoring  requirement is appropriate to verify the overall effectiveness of the accredited 
third -party certification body’s operations and performance in activities relevant to the third -
party certification program and the validity of its certification decisions.  Accordingly, we are not 
revising the annual certification body monitori ng requirements we proposed in § 1.621.   
(Comment  40)  We received some  comments on proposed § 1.621(b) specifically, which 
would require an accreditation body to consider any other “reasonably available” information 
relevant to a determination of whether  a certification body  is in compliance with this rule.  
Comments encourage us to set limits around assessments conducted in the wake of an incident, 
noting that a problem involving one certification/type of product should not involve review of all 
certific ations/products.  These comments did not want an incident in one sector (e.g., human 
food) to unnecessarily jeopardize a n accreditation in a separate sector (e.g., animal food).  Some 
comments express concern that proposed § 1.621(b) would require an accre ditation body to 
review every certificate issued by a certification body if one of the eligible entities it certified 
was placed on FDA import alert.  
(Response  40)  We decline the suggestions to narrow the scope of proposed § 1.621(b) or 
to direct how recognized accreditation bodies should consider other “reasonably available” 
relevant information, because it will depend on the facts of a particular situation.  In the wake of 86 
incidents, we expect the accreditation body  to take appropriate steps to determine  whether the 
certification body is in compliance with this subpart.  Such steps may include a review of 
certifications f or product areas other than the subject of the incident  if the accreditation body 
deems it needed  to assess the certification body ’s compliance .  We reiterate, as we explained in 
the preamble to the proposed rule, we do not expect a recognized accreditation body launch 
investigations of each certification body it accredited  absent cause , but we do expect the 
accreditation body to active ly monitor public information about their certification bodies and not 
ignore public information about problems that might be associated with a certification body it 
accredited.  
(Comment  41)  In response to our preamble questions about whether to require 
observations and certification body headquarters visits in § 1.621, some comments state that 
observations  are a useful tool and should be required.  Similarly, some comments support a 
requirement for visiting the key location of the certification body.  So me comments state that the 
accreditation body should visit any location of the accredited third -party certification body where 
the certification body manages its staff or agents conducting audits under this program, which 
the comments note may not be the c ertification body’s headquarters.  Other comments agree that 
onsite visits can be a useful tool, but encourage the use of remote assessments in certain 
circumstances (e.g., after the certification body has successfully completed a set number of 
accreditati on cycles).   
Some comments suggest that we follow the requirements of relevant ISO/IEC standards 
in establishing requirements for observations and site visits under § 1.621.  Some comments 
express concern about the cumulative burden of the monitoring and self-assessments we 
proposed to require of accreditation bodies and certification bodies.  A few comments express 87 
concern we might impose duplicative requirements for observations under §§ 1.621 and 
1.622(b).  Some  comments request guidance on how an eligi ble entity would be selected as a site 
for an observation .   
(Response  41)  We agree with the comments that state that observations are useful and 
should be required as part of accredited third -party certification body monitoring.  Likewise, we 
agree with the comments that state a recognized accreditation body should visit any location of 
the certification body where the certification body manages its staff or agents conducting audits 
under this program, if different than the certification body’s headquarte rs, to get a better 
understanding of how different locations operate .  While we acknowledge that some 
accreditation bodies may be successfully using remote assessments in certain circumstances 
(e.g., after the certification body has successfully completed a set number of accreditation 
cycles), we decline the suggestion to allow for remote assessments in this rulemaking .   
In establishing requirements in § 1.621 for observations and accredited third -party 
certification body visits, we considered comments’ concerns that such requirements might be 
duplicative of the observatio n requirements in § 1.622(b), might pose practical difficulties in 
arranging to observe audits , and might pose difficulties if a certification body had several “key” 
locations.  We also considered comments’ concerns about the cumulative burden of the 
monit oring and self -assessment requirements of the rule and the comments that urge us to align 
the requirements of § 1.621 with the relevant international standards.   
Accordingly , in the final rule we are combining all of the paragraphs in propos ed § 1.621 
into new  § 1.621(a), and we are adding a new paragraph (b) that requires the accreditation body 
to perform a representative  sample of onsite observations of regulatory  audits conducted by each 
accredited third -party certification body , as explained in Respons e 28,  and visit the certification 88 
body’s headquarters (or other certification body location if its audit agents are managed by the 
certification body at a location other than its headquarters).  The observed audits and site visits 
must be performed by no l ater than 12 months after the certification body’s initial accreditation 
and again every 2 years thereafter for the duration of its accreditation, including renewals.  The 
requirements for the frequency of observed audits and site visits under § 1.621(b) a re similar to 
the intervals for surveillance onsite assessments in one of the options under clause 7.11.3 of 
ISO/IEC 17011:2004 (Ref.  5).  We are also requiring the accreditation body to consider 
information from activities conducted under paragraph (b) in  the annual performance report of 
the accredited third -party certification body.   
We also are making a corresponding revision to § 1.622( b) to clarify that the 
accreditation body should consider the results of onsite observations and site visits conducted  
under § 1.621(b) as part of its self -assessment under § 1.622.  
C.  How Must a Recognized Accreditation Body Monitor Its Own Performance? (§ 1.622)  
Proposed § 1.622 would require recognized accreditation bodies to conduct self -
assessments on an annual basi s, and as required under proposed § 1.664(g) (following FDA 
withdrawal of accreditation of a certification body it accredited).  Under the proposed rule, the 
accreditation body’s self -assessment would include evaluating the performance of its officers, 
employees , or other agents; observing regulatory audits by a statistically significant number of 
certification bodies it accredited under this program, and creating a written report of results.  
(Comment  42)  Some comments encoura ge a broader self -assessment.  They contend 
that, in addition to requiring that accreditation bodies assess the consistency of their performance 
and their compliance with conflict of interest provisions, we should also require accreditation 
bodies to compare their performance against c ompetitors, compare the certification bodies they 89 
accredit to other certification bodies, and look at industry best practices and benchmarks to set 
improvement objectives.   
(Response  42)  The self -assessments are intended to help the accreditation body  
determine whether it is in compliance with the requirements of this rule.  While the report 
elements suggested by comments might be useful for an accreditation body to consider, we do 
not believe those elements are necessary to a determination of compliance with the rule.  
Therefore, we decline to revise the rule in response to these comments.  
(Comment  43)  Some comments question whether the requirements for accreditation 
body self -assessment would fit the government -to-government model.  Other comments  sugge st 
that the different nature of private operators and public administration warrant different 
requirements for each.  The comments further contend  that the workload associated with the 
program would be significant for any government agency; therefore, the time limits and 
frequencies of reporting should be more flexible in the case of government agencies . 
(Response  43)  FDA uses self -assessment tools in various government -to-government 
programs.  As one comment note s, we require State governments to conduct annual self -
assessments for their work under the Manufactured Food Regulatory Program Standards 
(MFRPS ) and the Animal Feed Regulatory Program Standards .  We also require a foreign 
government seeking a systems -recognition agreement with FDA to begin the process by 
completing the International Comparability Assessment Tool, which is a self -assessment tool 
that we developed based on the approach of the MFRPS self -assessment.  Our experience in 
using self -assessment to ols with foreign and State governments suggests to us that self -
assessments would be feasible and appropriate in the context of this program as well.  90 
We d ecline the suggestion to afford mo re flexibility in deadlines for  government agencies 
serving as recognized accreditation bod ies than we afford to other recognized accreditation 
bodies .  Section 808 of the FD&C Act  makes no distinction between public and private 
accreditation bodies , and the proposed rule would place the same workload burden on private 
accreditation bodies as it would on public accreditation bodies.  The comments fail to explain 
why the differences in nature of public and private accreditation  bodies justify flexible deadlines 
for governmental accreditation bodies but not  private accredita tion bodies.  
(Comment 44)  Some comments suggest that accreditation body self -assessments under 
proposed § 1.622 should be done in concert with its monitoring of certification bodies under 
proposed § 1.621, because it would be more efficient and would redu ce the burden on eligible 
entities  that were observed during regulatory audits .  Other comments question the need for 
accreditation body self -assessments to include requirements for observations , because they read 
our preamble discussion of proposed § 1.621 as a signal that we would be requiring accreditation 
bodies to conduct annual onsite observations of each certification body under that provision.   
(Response  44)  We agree that self -assessmen ts under § 1.622 can be done in concert with 
monitoring under § 1.621.  As described in Response 39, we do not intend the self -assessment 
and monitoring requirements of the rule to be duplicative.  Having added requirements for 
observations and certificati on body site visits to certification body monitoring requirements in 
the final rule, we are revising § 1.622(b) to clarify that accreditation bodies may consider the 
results of any observations  or visits conducted under § 1.621(b) in its self -assessments.   
(Comment 45)  Comments also suggest that international standards could provide 
guidance on improving the efficiency and effectiveness of an accreditation body’s self -
assessment.  Some comments specifically suggest that FDA could rely on the internal audi ts and 91 
management reviews that are required under ISO/IEC 17011:2004 (Ref. 5) instead of requiring 
its own self -assessments.   
(Response  45)  We agree that documentation of internal audits and management reviews 
required under ISO/IEC 17011:2004 (Ref. 5) could be useful to help demonstrate compliance 
with the requirement for self -assessments under this program. We  have revised § 1.622(d) and 
made a conforming change to § 1.623(b) to specifically allow a recognized accreditation body to 
use reports of inter nal audits and management reviews prepared for conformance with ISO/IEC 
17011:2004 (Re f. 5), supplemented as necessary,  to demonstrate compliance with the 
accreditation body self -assess ment requirements of § 1.622.   
D.  What Reports and Notifications Must  a Recognized Accreditation Body Submit to FDA? 
(§ 1.623)  
Proposed § 1.623 would require recognized accreditation bodies to submit to FDA 
reports of its self -assessments and annual re -assessments of certification bodies within 45 days of 
completing the assessment.  The proposed rule also would require notificatio n to FDA of matters 
affecting recognition and accreditation status; notice of denials of accreditation and any 
significant change that would affect how the accreditation body complies with this rule would be 
required within 30 days, while immediate notific ation would be required for other matters (e.g., 
grant or withdrawing accreditation).  Under the proposed rule the reports and notifications would 
have to be submitted e lectronically and in English.   
On our own initiative, we are revising § 1.623(c)(1)( i) and (d)(1)(i)  to require the 
recognized accreditation body to provide FDA the email address of any third -party certification 
body that was granted or denied accreditation (respectively) under our program .  Having the 
email address will facilitate FDA’s c ommunications with such third -party certification bodies.  92 
We also are revising § 1.623(c)(1)(iv) on our own initiative  to specify that a recognized 
accreditation body must also notify FDA of the expiration date of accreditation upon granting 
accreditation  to a third -party certification body under this subpart.   
(Comment  46)  Some comments ask whether FDA intends to provide feedback in 
response to self -assessment reports.  
(Response  46)  While FDA will not be providing formal responses to the self -assessmen t 
reports, we will use the information in the reports in our oversight of the third -party certification 
program and will address any specific items of concern we identify in an accreditation body -self-
assessment report directly with the accreditation body.  
(Comment  47)  We received several comments related to our proposal to require all 
reports and notification s to be submitted in English.  Some comments agree that both the 
notifications and the reports should be submitted in English.  Some comments agree t hat 
notifications should be in English, but suggested that reports of self -assessments and re -
assessments of certification bodies could remain in their native language, and if FDA had any 
questions about such reports the accreditation body could furnish En glish translations.  
Some comments no te the difficulty and others the expense for recognized accreditation 
bodies in countries that do not officially or routinely conduct business in English.  Some 
comments request a longer period of time ( e.g., up to 4 mon ths) to submit documents that must 
be translated into English.  Other comments note that if we require documents to be in English, 
and the translations are not done well, the documents may be difficult to understand.  
Some comments propose alternative solut ions, including comments that suggest that 
FDA explore technical translation and recognition software, which in combination with 
standardized report/notification templates, might facilitate submission in languages other than 93 
English.  Other comments sugges t that if reports and notifications are submitted in languages 
other than English, the recognized accreditation body should be responsible for all translation 
costs.  
Some comments ask whether supporting documents that accompany reports also would 
have to b e in English.  Other comments inquire whether there is any flexibility in the language 
requirement  for governmental accreditation bodies that do not maintain their records in English.   
(Response  47)  We decline the suggestion to remove the requirement to submit reports 
and notifications in English.   While allowing submissions in multiple languages might be helpful 
to some interested parties, the accreditation body reports and notifications required by § 1.623 
are essential to our oversight and management o f the third -party certification program and the 
programs that rely on certifications issued by accredited third -party certification bodies , and thus, 
must be in English in order for FDA to properly review and evaluate.  Some comments ask to 
have up to 4 mo nths to prepare an English translation of a submission under proposed § 1.623.  
Such delays would be unworkable.  For example, we cannot afford delays in translating an 
accreditation body’s notification of withdrawal of accreditation, or an accreditation b ody’s 
notification that a certification body has issued a food or facility certification without meeting the 
requirements of this rule.  We are requiring immediate notification of these and other matters 
under § 1.623(c) because of the implications for the  program and possibly for our acceptance of 
certifications issued by the certification body.  Unless the notification is submitted in English, 
our actions will be delayed until the information is translated.  Although the annual certification 
body monitori ng reports and the accreditation body self -assessments reports are not required to 
be submitted until 45 days after completion under § 1.623(a) and (b) (i) (and 60 days  following 
certification body withdrawal for self -assessment reports submitted under § 1. 623(b)(ii)), we will 94 
use these reports to identify areas where FDA may need to promptly engage with an 
accreditation body or a certification body to address apparent misunderstandings or confusion 
about our program requirements .  We plan to use these repor ts to identify emerging issues  that 
need intervention .  Therefore any additional time allotted for translation purposes would delay 
and possibly hinder our ability to use these reports for program evaluation and management.  
(Comment ) 48)  Some comments ad dress the proposed timeframes for submitting reports 
and notifications, and suggest that instead of requiring reports within 45 days of completing the 
assessment/re -assessment, we should require submission every 6 months or annually.   
(Response  48)  We disagree with comments suggesting that we modify  the timeframe  for 
submission of reports of annual self -assessments and annual certification body monitoring 
reports from 45 days after completion to every 6 months or  every  year.  We are concerned that 
the information could be outdated and our ability to use the reports for early intervention would 
be significantly diminished.   
(Comment  49)  Some comments contend that the volume of reports and notifications we 
proposed to require would be burdensome to FD A to review and maintain.  They suggest that 
instead we require recognized accreditation bodies and their certification bodies to maintain 
reports of self -assessment /re-assessment , and provide prompt access to FDA upon request.  
(Response  49)  We disagree.  We are establishing an electronic portal for submission of 
applications, reports, notifications, and other information under this rule and an electronic 
repository of this information, which will allow us to access and use the information as needed.  
Ther efore, we decline to revise § 1.623 is response to these comments.  
(Comment  50)  Some comments ask if all reports and notifications submitted to FDA will 
be subject to the Freedom  of information Act (FOIA)  or if these submissions will be considered 95 
confide ntial information with reasonable protections from disclosure.   Other comments suggest 
the importance of striking the appropriate balance between disclosure and confidentiality and 
note the following statements in ISO/IEC 17021 :2011 (Ref. 6) , clause 4.1.3 and NOTE:  
“Principles for inspiring confidence include:  Impartiality, competence, responsibility,  openness, 
confidentiality, and responsiveness to complaints …An appropriate balance between the 
principles of openness and confidentiality, including responsi veness to complaints, is necessary 
in order to demonstrate integrity and credibility to all users of certification.”   
(Response  51)  We agree with comments suggesting the importance of striking the 
appropriate balance between providing transparency to the public and maintaining the 
confidentiality of any trade secrets and confidential commercial information included in the 
applications, reports, notifications, and other information submitted to FDA.  We are guided in 
this effort by FOIA as well as laws that  protect trade secrets and confidential commercial 
information from disclosure.  In response to comments, w e are adding new § 1.695  on public  
disclosure , which is discussed  in section XIII.F.  
(Comment  51)  Some comments urge us to eliminate or reduce the proposed reporting 
requirements in proposed § 1.623(a) and (b), for various reasons.  Some of these comments 
suggest that  we should only require regular submission of a report or other document that shows  
the third -party certification bodies are maintaining their accreditation.  Other comments 
recommend that when a certification body is first accredited, it should submit translated 
accreditation documents within 3  to 4 months of the accreditation body’s de cision.  Then, as long 
as the accreditation is unchanged, it should not be necessary for the accreditation body to submit 
its--assessment reports under § 1.623(a).   96 
Some comments suggest it should not be necessary for accreditation bodies to submit 
their self-assessment reports under § 1.623(b) if there is no significant change in their 
recognition.  Other comments assert that signatories to IAF MLAs should not have to submit 
self-assessment reports to FDA, because IAF monitors accreditation bodies for con tinued 
compliance with ISO/IEC 17011:2004 (Ref. 5).   
(Response  51)  We disagree.  As described in Response 4 7, the reports of annual 
certification body monitoring and accreditation body self -assessments are essential to our 
oversight and management of the  third -party certification program and the programs that rely on 
certifications issued by accredited third -party certification bodies.  We are not requiring 
accredited third -party certification bodies to submit their self -assessments to FDA (except for 
directly accredited third -party certification bodies); therefore, the reports that we receive of the 
recognized accreditation bodies’ assessments of accredited third -party certification bodies are a 
fundamental piece of the monitoring system we are establishi ng, as are the self -assessment 
reports submitted by accreditation bodies we have recognized.  Reducing or eliminating either of 
these reporting requirements would hinder our ability to properly oversee the program.   
(Comment  52)  We received some requests  for clarification regarding required content of 
the accreditation self -assessment reports and reports of certification body annual monitoring.  
Some comments request that FDA either suggest a format for the reports, provide an opportunity 
for accreditatio n bodies to propose a format, or at least indicate the minimum required elements.  
(Response  52)  We believe we provided minimum requirements on the content of these 
reports in this rule and plan to provide additional information on the format and submissio n of 
these reports on our Web site.  97 
(Comment  53)  Comments suggest that to be consistent with ISO/IEC 17011:2004  (Ref. 
5), a recognized accreditation body only would need to notify FDA of the approval, suspension, 
or withdrawal of accreditation of a third -party certification body, as well as any changes in its 
scope of the accreditation scope or reduction of authorization.  The comments assert that the 
notification should not need to include such details as the address and name of third -party  
certification body employees  under § 1.624(c)(1).  
(Response  53)  We agree that submission of the information described in the comment 
and required by clause 8 of ISO/IEC 17011:2004  (Ref. 5)  is necessary for our program 
management and oversight.  For example, it will he lp us verify the identity of any certification 
body before taking an action to affect its status in the program based on a notification submitted 
under § 1.623.  However, the notifications required under § 1.623(c)(3) and (d) are also 
necessary for our pro gram management and oversight.  Under § 1.623(c)(3), a recognized 
accreditation body would have to notify FDA if one of its accredited third -party certification 
bodies issued a food or facility certification without complying with the requirements of this 
rule.  This notification will allow FDA to refuse to accept those improperly issued certifications 
and to coordinate with the accreditation body in determining appropriate next steps.  Having 
information on a denial of accreditation under § 1.623(d) will a llow FDA to monitor 
accreditation activities across the program, including any repeat denials of a third -party 
certification body.  
With respect to providing the names of the audit agents of the accredited third -party 
certification body, we note that section 808(b)(1)(B) of the FD&C Act requires a recognized 
accreditation body to submit to FDA a list of all third -party certification bodies it accredited 
under the program an d the audit agents of such accredited certification bodies.  The list of audit 98 
agents we proposed to require a recognized accreditation body to submit under § 1.623(c)(1)(iii) 
is necessary for verification of compliance with the conflict of interest requir ements by audit 
agents under section 808(c)(5)(A)(iii) and (B) of the FD&C Act and by proposed § 1.657, among 
other things.  With respect to the proposed requirement to provide the address and name of one 
or more of the officers of the accredited third -party certification body, this information will be 
helpful in communicating with the accredited third -party certification body.   
For the foregoing reasons, we decline the suggestion to eliminate the requirements for the 
recognized accreditation body to provi de FDA the name of one or more officers of the accredited 
third -party certification body under § 1.623(c)(1)(ii) and a list of audit agents of the accredited 
third -party certification body under §  1.623(c)(1)(iii).  
E.  How Must a Recognized Accreditation Body Protect Against Conflicts of Interest? (§ 1.624)  
Proposed § 1.624 would require a recognized accreditation body to take certain steps to 
safeguard against conflicts of interest, including the requirement to implement a written conflict 
of interest pro gram.  The accreditation body would be prohibited from owning, having a 
financial interest in, or managing/controlling a certification body.  Under the proposed rule, 
accreditation body employees  would be unable to accept money, gifts or other items of value 
from the certification body, though we did exempt meals of de minimis value onsite where the 
assessment occurs.  We also proposed to require that a recognized accreditation body maintain 
on its Web site a list of certification bodies it accredited under this program, the duration and 
scope of accreditation, and the date on which the certification bodies paid their fee or 
reimbursement associated accreditation.  We sought comment on alternative approaches for 
public disclosure of payments.  99 
On our own initiative, we are adding new provision §1.624(b) to clarify when a 
recognized accreditation body can accept the payment of fees for its services so that the payment 
is not considered a conflict of interest for purposes of § 1.624(a).  
(Comment  54)  Some comments agree that a recognized accreditation body should be 
required to have a written program to protect against conflict of interest.  Comments suggest that 
the written plans should include assura nces of independence and safeguards to address any 
possibility of conflicts.  Some comments state FDA should require accreditation bodies to make 
their conflict of interest policies public.  
(Response  54)  We agree with comments about the importance of a re cognized 
accreditation body having a written program to safeguard against conflicts of interest that meets 
the requirements of this rule.  While a recognized accreditation body may choose to make its 
conflicts of interest program publicly available, we are  not imposing that as a program 
requirement because we do not believe it is necessary to ensure that accreditation bodies 
safeguard against conflicts of interest.   
(Comment  55)  We received several comments related to allowing certification bodies to 
provide onsite meals of de minimis value to accreditation body representatives conducting an 
audit.  Several comments agree with the general concept of allowing meals of de minimis value.  
Some supporting comments state that allowing such meals would expedite the assessment, and 
could be necessary if the certification body is distant from meal service providers.  With respect 
to the question of what constitutes “de minimis” value for these purposes, s ome comments 
endorse the idea of defining de minimis value in  accordance with U.S. Government employee 
limits on accepting gifts or gratuities.  Others simply encourage us to define it in some way that 100 
ensures consistency and clarity.  Some comments state that we should not set a fixed amount for 
the de minimis valu e, because costs vary in different locations.   
Some comments disagree with the proposal to allow meals of de minimis value, and 
contend that the financial relationship between the accreditation body and the certification body 
should be strictly limited to  the fee paid for the accreditation audit/services.  
(Response  55)  We agree with the comments that suggest that allowing the certification 
body to provide meals of a de minimis value during an assessment and at the site where the 
assessment is being conduc ted might help facilitate the assessment, particularly for remote sites.  
We also agree with comments that state we should not set a fixed amount for the de minimis 
value because costs vary in different locations.    
We disagree with comments suggesting th at by providing meals of a de minimis value, a 
certification body might influence the outcome of an accreditation body assessment , particularly 
if the only allowable meals are ones of minimal value that are provided during the course of an 
activity and wit h the purpose of facilitating timeliness and efficiency.  FDA follows a similar 
approach for investigators conducting foreign inspections --that is, FDA investigators performing 
foreign inspections are allowed to accept lunches  (of little cost) provided by the firm during the 
course of a foreign inspection.  We also  note that the U.S. government allows its employees to 
accept meals, within per diem limits, when on official business in a foreign country, as an 
exception to the prohibition on the acceptance of  gifts or gratuities from outside sources (5 CFR 
2635.204(i)(1 )), though we believe the FDA’s practices for foreign inspections serve as a better 
model because foreign inspections are more analogous to foreign assessments than are the range 
of activities t hat covered by the general requirements applicable to all U.S. government 
employees on official business in foreign countries.  Accordingly,  in light of the comments 101 
received and  analogous FDA guidelines,  we have concluded that it is reasonable and appropr iate 
to limit the meal exception in § 1.624(a)(3)(ii) to only lunches of de minimis value provided 
during the course of an assessment, on site at the premises where the assessment is being 
conducted, and only if necessary to facilitate the efficient conduc t of the assessment.  We believe 
these revisions help to address concerns regarding the threats to impartiality, while 
accommodating the practical considerations that apply to foreign assessments.   
We offer the following additional input to recognized acc reditation bodies seeking 
guidance on the application of § 1.624(a)(3)(ii).  In considering whether a meal is allowable 
under this provision, we recommend that the assessor first consider whether accepting the lunch 
is necessary to facilitate the efficient  conduct of the assessment.  We recommend the assessor 
consider : (1) Whether the circumstances surrounding the travel would allow the assessor to p ack 
a lunch to bring on site; (2) W hether the meal is being provided during the midday or early 
afternoon.  A lunch provided in the midst of an assessment is different than a lunch or other meal 
provided at the completion of the audit; (3) Whether the site of the assessment is in close 
proximity to a retail food establishment, or is at a remote location far from a retail food 
establishment ; (4) What is the estimated value (or cost) of the lunch in light of the costs 
associated with the area where the assessment is being conducted; and (5) other similar 
considerations.   
For assessors seeking additional guidance on determining what constitutes a “de 
minimis” amount for purposes of complying with § 1.624(a)(3)(ii), we offer the following 
guidance that is based on the requirements applicable to U.S. government employees who accept 
certain meals while on official travel in foreign countries.  Such employees must deduct from the 
per diem the value of that meal , calculated using a two -step process.  102 
First, the individual must determine the per diem a pplicable to the foreign area where the 
lunch was provided, as specified in the U.S. Department of State's Maximum Per Diem 
Allowances for Foreign Areas, Per Diem Supplement Section 925 to the Standardized 
Regulations (GC,FA) available from the Superintend ent of Documents, U.S. Government 
Printing Office, Washington, DC 20402, and available on the Department of Stat e Web site at 
https://aoprals.state.gov/Web920/per_diem.asp .  (Foreign per diem rates are established monthly 
by the Department of State’s Offic e of Allowances as maximum U.S. dollar rates for 
reimbursement of U.S. Government civilians traveling on official business in foreign areas.)  
Second, the individual must determine the appropriate allocation for the meal within the 
daily per diem rate whic h is broken down into Lodging and M&IE (Meals & Incidental 
Expenses) that are reported separately in  Appendix B  of the Federal Travel Regulation and 
available on the Department  of State’s W eb site at 
https://aoprals.state.gov/content.asp?content_id=114&men u_id=78 .  
(Comment  56)  Our proposal to require accreditation bodies to maintain a Web site listing 
of certification bodies, and information about each, drew several comments.  Most comments 
agree with the Web site listing in principle.  Some comments enco urage us to require additional 
information in the Web site listing, such as requiring accreditation bodies to include in their Web 
site listing those certification bodies whose accreditations have been suspended or revoked.  
Some comments advise that the “ scope” information required on the Web site should be specific 
(e.g., whether the accreditation is for human food, animal food, or for specific rules).  
Additionally, many comments address the proposed requirement to include fee 
information in the Web site listing.  Some comments suggest that we require recognized 
accreditation bodies to specify what is included in the fee payment and what costs are 103 
reimbursable. We also received comments arguing that requiring payment schedules to be posted 
online is not su fficient to ensure that potential conflicts of interest will be identified; they 
suggested we require accreditation bodies to submit payment schedule information directly to 
FDA.  
Some comments disagree with the proposed requirement to require the Web site posting 
of payment schedules contending, among other things, that such information is proprietary. 
Some suggest that, instead, FDA should require accreditation bodies to keep records of payments 
which would be available to FDA if we have reason to examine them.  Others suggest it would 
be sufficient for the financial payment information to be maintained such that FDA could review 
it during the recognition/renewal process.  Still other comments seek clarification as to whether 
we would be requiring, in addit ion to the date of payment, the dollar value of payment.  These 
comments are not in favor of such a requirement; they state such payment details constitute 
sensitive information and argue that FDA should instead require the amount of payment to be in 
the records required under § 1.625.  
(Response  56) We agree with comments that state that an accreditation body’s Web site 
posting under § 1.624(c), finalized as §1.624(d), must include specific information about the 
scope(s) of accreditation, for example by rel evant part of 21 CFR or by a designation, such as 
“part 123” or “Seafood HACCP ” (Hazard Analysis Critical Control Point) .  We also are revising 
final § 1.624(d) to state that an accreditation body’s Web site must identify a certification body 
whose accreditation was suspended, withdrawn, or reduced in scope, because we believe that this 
information would be important to eli gible entities seeking information on accredited 
certification bodies.  The suspension or withdrawal information must be maintained on the Web 
site for 4 years (the maximum duration of an accreditation under the rule) or until the suspension 104 
is lifted or t he certification body is reaccredited by that accreditation body, whichever occurs 
first.   
In the interest of transparency, we are maintaining the requirement for accreditation 
bodies to post information on the timing of fee payments and direct reimbursem ents by 
certification bodies.  This posting requirement is similar to the posting requirements that apply to 
certification bodies under § 1.657(d) and will help build confidence in the impartiality of 
accreditation body accreditation decisions.  We are not  requiring posting of the amount of fees or 
reimbursement paid, because we do not think it is necessary to help build confidence in the 
impartiality of accreditation body accreditation decisions.  We agree with the suggestion to 
specifically require fee pa yment records to be maintained and are revising §  1.625 accordingly.   
(Comment  57) Some comments contend that § 1.624 is seriously flawed because it is 
inconsistent with “the latest science on the issue” and a 2009 Institute of Medicine (IOM) 
Report, “Con flicts of Interest in Medical Research, Education, and Practice.”  They encourage 
FDA to evaluate the most recent scientific research on conflicts of interest and consult with 
leading academicians involved in such work.  They contend that the fact of payme nt by the 
certification body to the accreditation body creates a conflict of interest that cannot be avoided so 
we should aim our regulation to minimize it.  They recommend that we prohibit any financial 
relationship between the accreditation body and a ce rtification body it audits for at least 1 year 
before accreditation was sought and 1 year after the last accreditation expires or was denied.   
(Response  57)  While we agree with the comments’ suggestion to remain vigilant in 
ensuring that our conflict of interest protections represent current best practices, we disagree with 
the assertion that § 1.624 is seriously flawed and have concluded that the suggested revision 
would be infeasible and impractical.  Third -party certification bodies currently accredite d for 105 
food safety auditing by accreditation bodies that become recognized by FDA would have to 
apply to another recognized accreditation body to join our program if the comment s’ suggestion 
were adopted.  This would create a disincentive to participation b y experienced third -party 
certification bodies and would pose difficulties when the availability of recognized acc reditation 
bodies is limited.   
In response to comments citing the 2009 IOM report on financial conflicts of interest 
between medical researche rs and medical products companies, we note that it identified some 
conflict of interest issues that also are relevant to our third -party certification program, such as 
the need to disclose payments from industry and to place limits on meals and gifts.  How ever, the 
differences between the context of medical research and practice and the context of our third -
party certification program pose difficulties in identifying practical implications of the analysis 
for our purposes --i.e., the analysis of data suggest ing that the acceptance of meals and gifts and 
other relationships may influence physicians to prescribe a company’s medicines.  Nor are the 
IOM recommendations readily adaptable to conflicts of interest in the third -party certification 
program.  The “best  practices” we employ must be suitable for the third -party certification 
program and may differ from the state of the art best practices for conflict of interests in medical 
research.  For example, the recommendations to place limits on the use of drug sam ples for 
patients who lack financial access to medications and to prohibit the claiming of authorship for 
ghost -written publications are not applicable to this program.  For the foregoing reasons, we 
decline the suggestion to prohibit any financial relatio nship, such as the payment of fees, 
between a recognized accreditation body and a certification body for at least 1 year before 
seeking accreditation and 1 year after the last accreditation expires or is denied.  106 
(Comment  58)  Some comments reject the notio n that there could be effective protections 
against conflict of interest.  Such comments consider third -party food safety audits to possess 
inherent shortcomings and believe that FDA itself should conduct any food safety inspections 
required by FSMA.  
(Response  58) We disagree with the notion that it is not possible to effectively protect 
against conflicts of interest.  Currently, accreditation bodies and certification bodies operate 
under a number of private schemes successfully, with reasonably effect ive protections against 
conflicts of interest.  We note that the primary regulatory functions of the third -party certification 
program are to facilitate participation in VQIP and to provide certifications for the purposes of 
section 801(q) of the FD&C Act.   At this time, we do not intend for private third -parties to 
conduct food safety inspections required by FSMA.  
F.  What Records Requirements Must an Accreditation Body That Has Been Recognized Meet? 
(§ 1.625)  
Proposed § 1.625 identifies specific types of documents a recognized accreditation body 
would be required to establish, control, and maintain to document compliance with applicable 
requirements (including applications for accreditation and for renewal; regulatory audit reports 
and supporting informati on from its accredited auditors/certification bodies; reports and 
notifications required under proposed § 1.623, along with any supporting information).  The 
recognized accreditation body would be required to provide FDA access to such records.  The 
rule a lso proposed to require records to be maintained electronically and in English for 5 years.   
In the proposed rule we acknowledged that the contracts between accreditation bodies 
and certification bodies frequently include confidentiality provisions that m ight otherwise 
prevent disclosure of certain records to FDA without prior approval of the certification body.  107 
We noted that any such contract provisions would need to be changed to allow the accreditation 
body to furnish FDA with the records identified in  this section.   
On our own initiative, we are including fee payment records as another type of record 
that an accreditation body that has been recognized must maintain under § 1.625(a) (8). 
(Comment  59)  Several comments disagree with the proposed requirem ent for records to 
be maintained in English.  Some comments, while noting their support for submission of reports 
and notifications in English under proposed § 1.623, disagree with our proposal to require that 
records maintained by the accreditation body b e kept in English as well.  Some comments, 
noting the cost of translating all records, request that we allow records to be maintained in the 
language of the country.  They propose we could require the accreditation body to provide the 
records in English up on our request within a reasonable time; some suggest a reasonable time 
might be a week, depending on the volume of records requested.  Other comments argue that the 
food industry is global and in recognition of that fact FDA should accept records in other  
languages.  Some comments suggest that we allow three or four additional widely -used 
languages.   
(Response  59)  We agree with the recommendation to allow records held by the 
accreditation body to be maintained in a language other than English, coupled wi th a requirement 
that, upon FDA request, the accreditation body must provide an English translation of the records 
within a reasonable time.   
The records required by § 1.625 are necessary to document the accreditation body’s 
accreditation activities, and we expect to request access to the accreditation body’s records as 
necessary to verify the accreditation body’s continuing compliance with the requirements of this 
rule, such as when we are considering whether to renew its recognition.  The accreditation b ody 108 
records also will be useful in helping to verify the compliance of certification bodies it accredited 
under the program.  However, the records required by § 1.625 are generally distinguishable from 
the reports and notifications that must be directly su bmitted to us under § 1.623, which we are 
requiring to be submitted to FDA in English because the reports and notifications submitted 
directly to us are time sensitive in nature and essential  to our management and oversight of the 
third -party certificatio n program.  For example, under § 1.623(c) we are requiring immediate 
notification, in English, of an accreditation body’s withdrawal of accreditation from a 
certification body.  We cannot afford delays in translating this information, because of its 
implications for t he program and possibly for our acceptance of certifications issued by the 
certification body.  Unless the notification is submitted in English, our actions will be delayed 
until the information is translated.   
By contrast, the records required under § 1. 625 typically contain information that is less 
time sensitive; therefore, reasonable delays for translation purposes will not compromise our 
ability to manage or oversee the program.  Accordingly, we are revising § 1.625 to allow other 
accreditation body r ecords to be maintained and submitted to FDA in languages other than 
English, provided that an English language translation of such records is provided within a 
reasonable time thereafter.  The circumstances surrounding each request will differ; therefore,  we 
decline to set a specific (numerical) deadline for submission of the translation.   
(Comment  60)  We received several comments expressing confidentiality concerns. 
Some comments note that documents that are part of an audit process may contain critical  
business information that warrants some level of proprietary protection.   109 
(Response  60)  We acknowledge comments’ concerns and note that we are including 
§ 1.695 on public disclosure in section XIII.F.   The new section explains that records obtained by 
FDA under this subpart are subject to the disclosure requirements under 21 CFR part 20 .  
(Comment  61)  With regard to the proposed requirement that records must be maintained 
electronically, some comments discourage us from requiring compliance with 21 CFR part 11, 
which are regulations setting certain electronic records criteria.  Comments contend that 
imposing part 11 requirements would be disproportionate to the need under this rule without an 
appreciable improvement in food safety and would create a trem endous and costly burden.  They 
encourage FDA to explicitly exclude records under this rule from part 11.  Comments propose 
that instead of imposing part 11 requirements, we require documentation of the chain of custody 
by requiring records to be signed an d dated when created or modified.  
(Response  61)  We acknowledge comments’ concerns and note that we are establishing 
§ 1.694 on electronic records in section XIII.E.  This new section will generally exempt records 
that are established or maintained to sati sfy the requirements of this subpart from the 
requirements of part 11.  
(Comment  61)  Some comments express concern that our proposed record keeping 
requirement was too broad; and others express concern about how we might use our authority to 
request recor ds.  Some comments request clarification of our proposed requirement that 
accreditation bodies’ records include any supporting information for the reports and notifications 
required under § 1.623.  Other comments suggest that our records requests should be  narrower 
when the recognized accreditation body is a foreign government than a records request to a 
recognized, nonprofit accreditation body.  Still other comments encourage us to clarify the 110 
circumstances under which FDA staff could request records and t o include a method for an 
accreditation body to object to an FDA records request.  
(Response 62)  The records we are requiring an accreditation body to maintain under 
§ 1.625 are necessary to document the accreditation body’s accreditation activities and it s 
compliance with the requirements of this rule.  We expect to request access to the accreditation 
body’s records in verifying an accreditation body’s continuing compliance with the requirements 
of this rule. While the details of each records request will vary depending on its circumstances, 
we will tailor our records requests under § 1.625 as narrowly as possible to reach program -
related records and exclude records that are irrelevant or insignificant to this program.  For 
example, the information an accre ditation body reports under § 1.623 may prompt us to request 
the underlying record to supplement the report as needed.  Or, when an accreditation body is 
requesting renewal of its recognition, we may request records to supplement information 
provided in th e application.   
Therefore, we believe it is unnecessary to develop administrative procedures for 
accreditation body challenges to FDA records requests.  We recommend accreditation bodies to 
fully consider the program requirements before deciding to pursue  recognition under the 
voluntary third -party certification program.   
(Comment  63)  We proposed that if FDA requests records electronically, the recognized 
accreditation body provide the requested records within 10 days.  Some comments contend that 
10 days  is insufficient time, and instead request a period of 3 months.  
(Response  63)  We believe that 10 days is ample time for accreditation bodies to 
electronically submit any requested records they are already required to maintain under this 
subpart.  We note  that we are revising the final rule to allow accreditation bodies to maintain and 111 
submit records in languages other than English, provided that they electronically submit an 
English translation within a reasonable time thereafter.  By allowing records to be submitted in a 
language other than English, accreditation bodies should be able to provide requested records 
electronically within 10 days.  
VII. Comments on Procedures for Recognition of Accreditation Bodies Under this Subpart  
A.  How Do I Apply  to FDA for Recognition  or Renewal  of Recognition ? (§ 1.630)  
We proposed to establish procedures for accreditation bodies to follow when applying to 
FDA for recognition or for renewal of recognition.  We proposed that the accreditation body 
must submit a signed application, accompanied by any supporting documents, electronically and 
in English, demonstrating that it meets the eligibility requirements in proposed § 1.610.  We also 
proposed to require an applicant to provide any translation or interpretation  services we need to 
process the application.  
(Comment  64)  Some comments assert that the proposed rule does not differentiate 
adequately between foreign governments and private entities that are serving as accreditation 
bodies and suggest that we provide a separate path for recognition of foreign government 
accreditation bodies that prioritizes their applications over those submitted by private 
accreditation bodies.  The comments recommend that we draft additional rules to specifically 
cover recognition of  foreign government accreditation bodies and/or direct accreditation of 
foreign government certification bodies.   
(Response  64)  We disagree with the recommendation to create a bifurcated system for 
recognition, because the line between governmental and p rivate accreditation bodies is not 
always clear.  Private accreditation bodies comprise approximately one third of the 72 
accreditation bodies that accredit food safety certification bodies around the world, according to 112 
a report prepared by the Research T riangle Institute (RTI) (Ref. 16).  In the report, RTI found 
that the distribution of accreditation bodies by private versus government agency is as follows:  
24 private accreditation bodies, 38 governmental accreditation bodies, and 10 accreditation 
bodie s with unknown private or government agency status.  RTI found that the vast majority of 
the private accreditation bodies were non -profit entities.  Many of the private accreditation 
bodies identified by RTI operate under government sanction or in quasi -governmental roles.  For 
example, the American National Standards Institute (ANSI) is a private, non -profit accreditation 
body that serves as the official U.S . representative to ISO (Ref. 17); the United Kingdom 
Accreditation Services is appointed as the nat ional accreditation body for the United Kingdom, 
though it is indepe ndent of the government (Ref. 18); and the Danish Accreditation and 
Metrology Fund is a self -described “business fund” that is appointed by the Danish Safety 
Technology Authority as the na tional accredi tation body for Denmark (Ref. 19).  Additionally, 
we note that section 808 of the FD&C Act makes no distinction in the requirements or process 
for recognizing public or private accreditation bodies.  Furthermore, we do not believe it 
practica l to engage in additional rulemaking for foreign government accreditation bodies and 
certification applications, as the comments suggest.   
(Comment  65)  Some comments ask us to accept applications in other languages common 
to the major production areas ex porting product to the United States.  These comments assert that 
due to the global nature of produce supply chains allowing applications in other languages would 
encourage supply chain participation in third -party auditing programs as a tool to improve fo od 
safety.  These comments suggest that we could develop a phased process where we only accept 
English applications initially, but increase flexibility to accept applications/renewal documents in 
other languages as the program builds up.  113 
(Response  65)  We acknowledge that accepting applications for recognition in languages 
other than English might be beneficial to some interested parties.  However, requiring 
applications for recognition to be submitted in English will help us make well -informed and 
timely d ecisions.  Further, FDA does not have the resources to translate or review documentation 
in other languages and generally requires documents submitted in other languages to be 
translated to English.  Therefore, we decline the suggestion to develop long -term plans for 
accepting applications for recognition in languages other than English.   
(Comment  66)  Some comments ask what costs are associated with getting recognized as 
an accreditation body.  
(Response  66)  Pursuant to section 808(c)(8) of the FD&C Act, we issue d proposed 
regulations to establish a reimbursement (user fee) program to assess fees and require 
reimbursement for the work performed to establish and administer the third -party certification 
program.  The proposed rule provides details on how use r fees would be computed  (80 FR 
43987, July 24, 2015 ). 
B.  How Will FDA Review my Application  for Recognition  or for Renewal  of Recognition and 
What Happens Once FDA Decides on my Application ? (§ 1.631)  
We proposed to establish procedures for reviewing and  deciding on applications for 
recognition and for renewal of recognition.  We proposed to order the application queue on a 
first in, first out basis and to only place complete applications in the queue.  
On our own initiative, we are revising paragraph ( a) to clarify that FDA will review 
submitted applications for completeness and will notify applicants of any identified deficiencies.  
We also are revising paragraph ( b) to clarify that FDA’s evaluation of any completed recognition 114 
or renewal application may include an onsite assessment of the accreditation body.   In addition, 
we are redesignating proposed paragraph (e) as part of paragraph (b) for clarity.   
On our own initiative we are adding new paragraphs (e) through (h)  to § 1.631  to explain 
what happens w hen an accreditation body’s renewal application is denied.  We are adding 
provisions to clarify what the applicant must do, the manner in which FDA will notify accredited 
third -party certification bodies and the public of the denial, the effect of denial o f an application 
for renewal of recognition on accredited third -party certification bodies, and the effect of denial 
of an application for renewal of recognition on food or facility certifications issued to eligible 
entities .. 
(Comment  67)  Some comments ask us to clarify how we will recognize an accreditation 
body.  Some comments ask that we clearly and comprehensively lay out the conditions and 
requirements governing the application for recognition, to ensure transparency, certainty, and 
predictability o f the procedures and criteria governing recognition.  Some comments specifically 
recommend that we use the IAF /ILAC /International Laboratory Accreditation Cooperation 
(ILAC ) (A-series) documents as the foundation upon which to base our process for recognit ion 
of accreditation bodies.   
(Response  67)  This rule establishes the framework for the third -party certification 
program and generally describes procedures involved in the submission and processing of 
applications for recognition and will be supplemente d by additional instructions.  For example, 
we are developing an electronic portal that accreditation bodies will use in submitting their 
applications for recognition, and we will be issuing directions for using the portal.  We also are 
developing internal  operational procedures for recognition of accreditation bodies and will 
consult the IAF/ILAC (A -series) documents in considering the types of materials that may be 115 
useful to accreditation bodies and other stakeholders interested in learning more about our  
program.  
(Comment  68)  Some comments express concern that we are limiting ourselves to a “first 
in, first out” review process that gives us no discretion to recognize foreign governments before 
we consider other applications from private accreditation bod ies that apply.  These comments 
recommend that we use guidance to industry or internal management documents, rather than this 
rule, to describe how we will establish the queue of applications for review.  
(Response  68)  For the reasons described in Respons e 64, we decline the suggestion to 
prioritize applications submitted by government accreditation bodies over applications submitted 
by private accreditation bodies.  However, we are modifying the first in, first out approach to 
application review in propos ed § 1.631 (a) to allow FDA to prioritize an application for review 
based on program needs.  We will consider  the suggestion to use an internal management 
document to establish our procedures for reviewing applications for recognition as part of our 
operati onal planning.   
(Comment  69)  We received several comments on the timeliness of application review 
and decisionmaking.  Some comments assert that our application review process must be 
comprehensive but also expedient.  Some comments ask that our communic ations with 
applicants be timely.  Other comments ask us to establish review timeframes by which 
accreditation bodies and other interested parties may expect a response to applications, asserting 
this will foster enhanced confidence and transparency with t he review process. Some comments 
suggest that we review and act upon an accurately completed recognition application within 90 
days and a completed recognition renewal application within 45 days.   116 
(Response  69)  We agree with the comments suggesting that our application review must 
be comprehensive and as expedient as possible.  We decline the suggestion to establish review 
timelines in this rule because we lack the experience and data that would allow us to reasonably 
estimate review timeframes.  We also recognize that each review will differ depending on the 
circumstances, and we expect to become more efficient in application review as we gain 
experience in the program.   
(Comment  70)  Some comments express concern about the length of time it will take us  
to recognize and notify an applicant of any deficiencies in the application.  These comments also 
assert that requiring applicants with deficiencies to resubmit their applications and sending them 
to the bottom of the review list would make for significan t delays in the recognition and renewal 
processes.  
(Response  70)  FDA agrees that an application for recognition should be checked for 
completeness promptly after submission.  The Agency intends to notify the submitter in a timely 
manner if the submission is not complete.  FDA anticipates that this completeness determ ination 
could generally be made within 15 business days, because this is not a decision on the merits of 
the application.  However, given the competing demands on Agency resources, including staff 
available to conduct review, the Agency declines to add a t ime restriction in the final rule for 
notifying an applicant of deficiencies that cause its application to be considered incomplete and 
thus not ready for processing.   
(Comment  71)  Some comments assert that we should include a mechanism for 
stakeholders to provide feedback to the Agency concerning the capacity and functioning of 
accreditation bodies and auditors/certification bodies because stakeholders have firsthand 
experience with such entities.   These comments suggest that we modify § 1.631(b) to spec ify that 117 
FDA will also “solicit and consider information provided by stakeholders, including importers 
and foreign suppliers subject to the accreditation body’s jurisdiction, to assist in the recognition 
or renewal application review process.”  
(Response  71)  To  the extent the comments suggest that the Agency’s review and 
decisionmaking process on recognition applications should include a solicitation of comments 
from the public we disagree, as this would create unnecessary delay in the recognition process.   
FDA believes that the information it gains through the application process will be sufficient to 
make a recognition determination, and that this process and subsequent monitoring by FDA 
ensures robust oversight of the program.  Nevertheless, stakeholders  are always free to share 
with FDA any information relevant to the Agency’s food safety programs.  We note that 
information shared with FDA is subject to the information disclosure regulations in part 20, as 
stated in §  1.695.  
(Comment  72)  Some comments n ote that there are no circumstances or conditions in the 
proposed rule that allow for an accreditation body to question or object to an FDA action or 
request if they believe it is not reasonable or relevant to the recognition and performance of the 
accredi tation body.  
(Response  72)  We do not expect to make requests or actions of an accreditation body 
that are not relevant to the requirements of the third -party certification program.  FDA’s 
evaluation of accreditation bodies, as expressed in §§ 1.631(b), 1 .633(a), and 1.634(a), is 
premised on the accreditation body’s compliance with the applicable requirements of this rule.  
We note that in this rulemaking, FDA has established a number of mechanisms to address 
challenges to FDA’s decisions, including  § 1.69 1 (for requests for reconsideration of the denial 
of an application for recognition, renewal, or reinstatement of recognition); § 1.692 (for internal 118 
Agency review of the denial of an accreditation body application upon reconsideration); and 
§ 1.693 (for r egulatory hearings on revocation of recognition).   
We recommend accreditation bodies to fully consider the program requirements before 
deciding to pursue recognition under the voluntary third -party certification program.   
(Comment  73)  Some comments ask that we provide training and education documents 
regarding the application process as quickly as possible to ensure that accreditation bodies are 
clear on the process and its requirements.  These comments assert that training and education 
would minimize t he need for second reviews due to inaccurate or incomplete applications.  
(Response  73)  As indicated in Response 67, we are developing additional instructions 
for applications for recognition that will be useful to accreditation bodies interested in pursuing 
recognition.  
C.  What is the Duration of Recognition ? (§ 1.632)  
We proposed to grant recognition to an accreditation body for up to 5 years, though we 
will determine the length of recognition on a case -by-case basis.   
(Comment  74)  Some comments support our proposal to recognize accreditation bodies 
for a duration of up to 5 years, with shorter durations awarded early in the program for 
accreditation bodies with little experience in accrediting third -party certification bodies.  
(Response  74)  We agree with comments suggesting that the duration of recognition may 
vary depending on a number of factors, including the accreditation body’s history (or lack of 
history) in accrediting certification bodies.  We believe the proposal allows FDA to consider 
such factors.  
(Comment  75)  Some comments express concern that we are not proposing a fixed 
duration of recognition and ask us to establish a specific time limit of 5 years.  These comments 119 
assert that having a standardized duration of recognition for all accreditation bodies is 
administratively more viable for FDA to plan its resource needs and would provide consistency 
across the industry.  Additionally, these comments assert that 5 years is a reasonable duration 
given the other reporting and monitoring r equirements built into the system.  
(Response  75)  We acknowledge the advantages that certainty provides and, where 
appropriate, the Agency will grant recognition for the maximum duration of 5 years.  However, 
as noted in our previous response, we also rec ognize it may be appropriate for the duration of 
recognition to vary depending on a number of factors.  Where, for example, an accreditation 
body has little or no experience in accrediting food safety certification bodies, we may decide the 
initial grant o f recognition should be less than 5 years.  
(Comment  76)  Some comments suggest that the duration of recognition for an 
accreditation body should be 4 years to be consistent with the duration proposed for accreditation 
of certification bodies in § 1.661.  O ther comments request clarification about the difference in 
durations proposed for recognition of accreditation bodies and accreditation of certification 
bodies.  
(Response  76)  We decline the suggestion to shorten the maximum duration of 
accreditation body  recognition to 4 years and note that the comments suggesting it should be the 
same maximum duration as third -party certification body accreditation offered no information 
that would provide an adequate basis for shortening recognition such that an accredi tation body 
could be recognized for no longer than a certification body’s accreditation.   Further, as stated in 
the proposed rule, we noted that other government programs such as the Substance Abuse and 
Mental Health Services Administration program for acc redited programs that use opioid agonist 
treatment medications approves accreditation bodies for up to 5 years (42 CFR 8.3).  Under the 120 
FDA mammography program, we may approve accreditation bodies for terms up to 7 years (21 
CFR 900.3(g)).  As stated previ ously, FDA may establish a period of recognition of less than 5 
years if appropriate for a particular applicant.  
(Comment  77)  Some comments assert that accreditation bodies that maintain their IAF 
signatory status should not be limited to a 5 -year duratio n.  
(Response  77)  We decline the suggestion, noting that the comment lacks information 
demonstrating that a longer term of recognition is warranted for an accreditation body that is an 
IAF signatory.   
D.  How Will FDA Monitor Recognized Accreditation Bod ies? (§ 1.633)  
We proposed to establish the frequency and manner for formal evaluations of recognized 
accreditation bodies.  Specifically, we proposed to evaluate each recognized accreditation body 
by at least 4 years after the date of recognition of an ac creditation body granted a 5 -year term of 
recognition and by no later than the mid -term point for an accreditation body granted a term of 
recognition of less than 5 years.  Proposed § 1.633 also notes that FDA may conduct additional 
assessments of recogniz ed accreditation bodies at any time.  
(Comment  78)  While the comments generally support FDA performance assessments of 
recognized accreditation bodies, the comments express a wide range of views on how frequently 
such assessments should occur.  Some commen ts support the proposed reevaluation frequency 
for recognized accreditation bodies.  Some comments assert that we need to have a more suitable 
monitoring mechanism.  Other comments suggest we incorporate a random, unannounced 
performance review for recogni zed accreditation bodies as a supplement to the proposed 
frequency.  Some comments take a contrary view, asking us to clarify in the final rule the 
circumstances under which we may perform additional performance assessments of recognized 121 
accreditation bodi es.  These comments assert that FDA’s ability to conduct additional audits, 
assessments , and investigations without the requirement to justify such actions creates the 
potential for a confrontational relationship and lack of trust.  The comments question whether , 
without such clarification, any refusal by an accreditation body to grant FDA access or 
information would trigger revocation of their recognition.  Still other comments request 
clarification on the frequency of audits that will be conducted on acc reditation bodies.   
(Response  78)  Monitoring assessments of accreditation bodies are one of several tools 
we will use for program oversight.  Section 1.633(a) implements section 808(f) of the FD&C 
Act, which states that FDA must reevaluate a recognized a ccreditation body periodically, or at 
least once every 4 years, and take any other measures FDA deems necessary to ensure 
compliance.  We anticipate that information gleaned from other monitoring tools, such as an 
accreditation body’s self -assessment, may prompt additional performance assessments in certain 
instances.  Although we decline to specifically codify random, unannounced performance 
reviews as a supplement to the proposed frequency as suggested by the comment, we note that 
under § 1.633(a) FDA may  conduct additional assessments of recognized accreditation bodies, 
including unannounced assessments, at any time as it deems appropriate.  We need to retain 
flexibility to conduct additional audits, assessments and investigations to support the credibili ty 
of the program.   
With respect to the request to clarify whether any refusal to grant FDA access or 
information for a performance assessment would trigger revocation, under section §  1.634(a), 
refusal to allow FDA to conduct an assessment to ensure the accreditation body’s continued 
compliance with the requirements of this subpart is grounds for revocation.    122 
(Comment  79)  Some comments assert that we should provide additional detail on our 
monitoring procedures under § 1.633(b).  Some comments express concern about the ambiguity 
of the term “statistically significant” as well as the scope of onsite assessments and onsite audits 
for performance evaluation purposes.  These comments assert that we must provide clear 
guidance to industry as to what we expec t would be involved in such onsite assessments and 
make this guidance available for public comment.  Other comments specifically request that we 
outline the procedures under which we will conduct audits on accreditation bodies and third -
party certification  bodies and specify a timeframe for when we will issue the results of the audits.  
Still other comments assert that we must provide guidance on how an eligible entity might be 
selected for an audit/inspection that relates to an accreditation body’s reasses sment of a 
certification body.   
(Response  79)  The objective of an assessment under § 1.633 will be to determine an 
accreditation body’s compliance with the requirements of this rule.  When planning an 
assessment, we will establish the time period of acti vities covered by the assessment and may 
request records of an accreditation body under § 1.625.  We also will develop plans for any 
locations to be visited, which may include the accreditation body’s headquarters and any other 
locations where employees  and other agents who conduct activities under this program are 
managed.   
In conducting the assessment, we may review records, such as records relating to 
conflicts of interest and may interview officers, employees , and other agents of the accreditation 
body .  We also may observe regulatory audits by certification bodies the accreditation body has 
accredited.  For the reasons explained in Response 28, we have removed the phrase, “statistically 
significant” and revised the sentence to explain that we may obser ve a “representative sample” of 123 
certification body regulatory audits when conducting an assessment of its accreditation body.  
We will decide what constitutes a “representative sample”  for purposes of  § 1.633  on a case -by-
case basis, based on factors such  as how many certification bodies the accreditation body has 
accredited under the program, the scope of accreditation of the certification bodies accredited by 
the accreditation body, how many years the accreditation body has been in the program, how 
many prior assessments of the accreditation body we have performed, and the length of time 
since any prior assessments.   
(Comment  80)  Some comments ask that we inform recognized accreditation bodies prior 
to doing onsite assessments of accredited certificatio n bodies and eligible entities as part of our 
performance evaluations.  
(Response  80)  In planning an assessment with onsite observations of certification bodies 
or an audit of certified eligible entities, we will consider whether to provide notice to the 
accreditation body and/or invite the accreditation body to be present.  In some circumstances we 
may determine that it would be necessary or appropriate to conduct the assessment or audit 
without notice to the accreditation body.   
(Comment  81) Some comment s assert that to carry out performance evaluations for the 
purpose of monitoring recognized accreditation bodies, we must have an agreement directly with 
the certification bodies or request that recognized accreditation bodies include these 
requirements in  their agreements with certification bodies they have accredited.  
(Response  81)  We disagree that we must have an agreement directly in place with each 
accredited certification body for us to carry out performance evaluations, as §  1.633(b) states that 
FDA  may include onsite assessments of a representative sample of third -party certification 
bodies the recognized accreditation body accredited and onsite audits of a representative sample 124 
of eligible entities certified by such third -party certification bodies  under this subpart.  We 
recommend that third -party certification bodies fully consider the program requirements before 
deciding to pursue accreditation under this voluntary third -party certification program. We also 
encourage recognized accreditation bodi es to include language in their standard contracts with 
third -party certification bodies they accredit under this program that acknowledges FDA’s ability 
to conduct such evaluations.  
(Comment  82)  Some comments ask who will cover the costs of audits on recognized 
accreditation bodies.   
(Response  82)  As discussed in Response 66, we are proposing in a separate rulemaking 
(80 FR 43987 ) the costs of FDA monitoring of recognized accreditation bodies wi ll be covered 
by user fees that we will establish by regulation.   
E.  When Will FDA Revoke Recognition ? (§ 1.634)  
Proposed § 1.634 establishes the criteria and procedures for revocation of recognition of 
an accreditation body, including requests for records and notifications. It describes several 
circumstances that warrant revocation of recognition and describes the e ffects (if any) of 
revocation on accreditations and certifications occurring prior to the revocation.  
On our own initiative, we are revising § 1.634(c) (2) to require the accreditation body to 
notify FDA of the name and contact information of the custodian  who will maintain the records 
required by § 1.625 instead of just providing us with a location to increase flexibility.   We are 
making corresponding changes to §§ 1.635(a ), 1.664(e)(2) , and 1.665(a ).  We also are revising 
paragraphs (d) through (f) to clarify the manner of FDA’s notice to affected third -party 
certification bodies and the public of the revocation, as well as the effect of such revocation on 125 
the accredited third -party certification bodi es and certifications they issued prior to issuance of 
the revocation of recognition.  
(Comment  83)  Some comments recommend that when an accreditation body’s 
recognition is revoked, the information on the Web site includes the cause or causes of the 
revoca tion. 
(Response  83)  We agree and will include on the FDA Web site a brief description of the 
grounds whenever revoking the recognit ion of an accreditation body.   
(Comment  84)  Some comments agree that providing the certification body 1 year to 
transition  and become accredited with another accreditation body is a reasonable concept, but 
express concerns that in many countries a limited number of accreditation bodies may make 
meeting that timeframe difficult.  They also note that although audited entities’ certifications 
may remain in effect until its expiration, it may be difficult for them to maintain their 
certifications beyond that date due to lack of accreditation bodies, or there may be instances in 
which their certification is set to expire in weeks o r months following the revocation.  These 
comments note a similar concern about the impact of a lack of capacity on scheduling 
certification audits should the certification body have to be reaccredited within 1 year.  
Comments recommend that FDA address th is issue by performing an assessment of accreditation 
capacity in key production regions around the world and using that information as a baseline to 
inform timeframes on re -accreditation of third -party certification bodies .  Other comments 
suggest that ei ther FDA be required to renew the recognition of the recently revoked 
accreditation body or recognize a new accreditation body in time for any affected accredited 
certification body to comply, or FDA would be required to solicit applications for a new 
accreditation body after an accreditation body’s recognition is revoked.  Comments also 126 
recommend that certifications issued by a certification body accredited by the accreditation body 
whose recognition was revoked remain in effect for 1 year from the date of  the revocation of the 
accreditation body in order to reduce the likelihood of a lapse in certification of eligible facilities.  
(Response  84)  We acknowledge that revocation of the recognition of an accreditation 
body may present difficulties for the cert ification bodies accredited by the accreditation body 
(and for the eligible entities those certification bodies certified), particularly in countries that 
have a single national accrediting authority.  In such circumstances, we intend to work with 
recogniz ed accreditation bodies and the certification bodies to identify opportunities and 
challenges.  We believe 1 year is sufficient time for a certification body to be reacc redited in 
such circumstances.   The requirement for an eligible entity to become recert ified after a 
certificate terminates by expiration is based on section 808(d) of the FD&C Act, which requires 
an eligible entity to apply for annual recertification.  In light of the foregoing, we are declining 
the requests to extend the deadlines for reac creditation and for recertification in the case of 
revocation of recognition of an accreditation body.  
(Comment  85)  Some comments request FDA provide specific provisions to address 
potential questions that may arise if recognition of an accreditation body is revoked, with 
particular emphasis on the validity of certificates or other documentation already issued when 
revocation occurs.  
(Response  85)  Section 1.634(d) specifically describes the impact of revocation of 
recognition of an accreditation body on the certification bodies that it accredited under this 
program, including that a certification body’s accreditation w ill remain in effect if it provides a 
self-assessment to FDA within 60 days of issuance of the revocation and it is accredited by 
another recognized accreditation body or FDA no later than 1 year after the revocation or the 127 
original date of expiration of t he accreditation, whichever comes first.  Section 1.634(e) explains 
that in the case of revocation of an accreditation body’s recognition, a food or facility 
certification issued by a certification body accredited by the accreditation body prior to the 
revocation of its recognition will remain in effect until the certification terminates by expiration.   
(Comment  86)  Some comments request that FDA clarify how individual holders of 
certifications would be made aware of the revocation of recognition.  For ex ample, they ask if 
FDA would contact certification holders directly or if the certification holder would be required 
to monitor the recognition status of the accreditation and certification bodies.  
(Response  86)  We will provide notice on the FDA Web site  when we revoke the 
recognition of an accreditation body.  We also will notify certification bodies that have been 
accredited by the accreditation body that has had its recognition revoked through the electronic 
portal we are establishing.  Because revocat ion of recognition will not affect the duration of 
previously issued certificates, we will not directly contact eligible entities to inform them of the 
revocation.  If the revocation of recognition results in the withdrawal of accreditation of a 
certificat ion body, FDA will provide no tice of such withdrawal on our W eb site as provided in 
§ 1.664(h).  
(Comment  87)  Some comments recommend that FDA refer to the provisions in ISO/IEC 
17011:2004 and ISO/IEC 17021:2011 to inform the provisions revocation of recog nition in 
§ 1.634 and withdrawal of accreditation in §  1.664 and to distinguish those actions from 
reduction in scope of recognition and accreditation and to establish the specific grounds and 
effects for those actions.  
(Response  87)  Neither of the ISO/I EC standards cited in the comments relate to 
revocation of recognition of an accreditation body; however, we reviewed ISO/IEC 17011:2004 128 
(Ref. 5) for terminology, procedures, and grounds that might have relevance for revocation of 
recognition in §  1.634.  We decline the suggestion to consider ISO/IEC 17021:2012 (Ref. 6), 
which applies to certification bodies, for purposes of this analysis as it is inapplicable.   
Having reviewed ISO/IEC 17011:2004, we note that ISO/IEC 17011:2004 (Ref. 5) gives 
an accredita tion body the flexibility to establish its own procedures for suspension, withdrawal, 
or reduction of the scope of an accreditation as explained in clause 7.13.1 and NOTE.  FDA’s 
procedures for revocation of recognition are thus not inconsistent with the I SO standards in this 
respect.  Regarding the grounds for withdrawal of accreditation, ISO/IEC 17011:2004 (Ref.  5), 
clause 7.13, provides that an accreditation body must make decisions to suspend and/or withdraw 
accreditation when an accredited conformity a ssessment body (i.e., third -party certification 
body) has persistently failed to meet the requirements of accreditation or to abide by the rules for 
accreditation.  The standard for revocation of recognition under this program is established by 
section 808 (b)(1)(C) of the FD&C Act, which requires FDA to “promptly revoke the recognition 
of any accreditation body found not to be in compliance with the requirements of this section,” 
which is the standard that is used in proposed § 1.634.  Therefore, we cannot incorporate this 
standard for withdrawal for purposes of this program.  
(Comment  88) Some comments suggest FDA revise § 1.634(a)(3) and (4) to provide that 
FDA can make a decision to revoke recognition or withdraw accreditation only when it has 
objective evidence to demonstrate that the recognized accreditation body committed fraud or 
submitted material with significant false statements, demonstrated a significant bias or 
significant lack of objectivity when conducting activities, or significantly failed t o adequately 
support one or more decisions to grant accreditation.  129 
(Response  88) We disagree.  Section 808(b)(1)(C) requires FDA to promptly revoke the 
recognition of any recognized accreditation body found not to be in compliance with section 808 
of the F D&C Act, which establishes the third -party program.  This program is a system of 
assurances that begins with the recognition of qualified accreditation bodies, which in turn 
accredit certification bodies to make judgments about  the compliance of eligible e ntities and the 
food they produce with the applicable food safety requirements of the FD&C Act and FDA 
regulations .  FDA’s ability to have swift recourse when a recognized accreditation fails to 
comply with the requirements of the third -party program  is essential .  Limiting FDA’s ability to 
revoke the recognition of accreditation bodies to instances of “significant” fraud, bias, or lack of 
competence as the comment suggests would render the program unreliable to provide the 
assurance of food safety intended  by this section.  
F.  What if I Want  to Voluntarily Relinquish Recognition or Do Not Want to Renew  
Recognition ? (§ 1.635)  
Proposed § 1.635 describes the procedures that an accreditation body must follow when it 
intends to relinquish its recognition.  
FDA received comments in support of the proposed procedures for voluntary 
relinquishment of recognition.  FDA received no adverse comments on this section.  On our own 
initiative, we are revising the voluntary relinquishment provisions in § 1.635 to also addre ss 
situations where a  recognized  accreditation body  decides it does not want to renew its 
recognition once it expires.  In addition we are including procedures for the certification bodies 
to follow after their accreditation bodies’ recognitions are relinq uished or not renewed.  130 
G.  How Do I Request Reinstatement of Recognition ? (§ 1.636)  
Proposed § 1.636 describes the procedures that an accreditation body would have to 
follow when seeking reinstatement of its recognition.  
FDA received comments in support of the proposed procedures for reinstatement of 
recognition.  FDA received no adverse comments on this section and is not making any 
substantive changes to this section in this final rule.  
VIII.  Comments on Accreditation of Third -Party Certification Bodie s Under this Subpart  
A.  Who is Eligible  to Seek Accreditation ? (§ 1.640)  
Proposed § 1.640 states that a foreign government, agency of a foreign government, 
foreign cooperative, or other third -party  would be eligible for accreditation from a recognized 
accreditation body (or, where direct accreditation is appropriate, FDA) to conduct food safety 
audits and issue food and facility certifications under the program.  Proposed § 1.640(b) is based 
on sect ion 808(c)(1)(A) of the FD&C Act and would require a foreign government/agency 
seeking accreditation to demonstrate that its food safety programs, systems, and standards would 
meet the requirements of proposed §§ 1.641  to 1.645, as specified in FDA’s model  standards on 
qualifications for accreditation, including legal authority, competency, capacity, conflicts of 
interest, quality assurance, and records.  Proposed § 1.640(c) is based on section 808(c)(1)(B) of 
the FD&C Act and would require a foreign cooper ative or other third -party  certification body 
seeking accreditation to demonstrate that the training and qualifications of its audit agents and 
the internal systems used by the certification body would meet the requirements of proposed 
§§ 1.641  to 1.645, a s specified in FDA’s model standards on qualifications for accreditation, 
including legal authority, competency, capacity, conflicts of interest, quality assurance, and 
records.  131 
At our own initiative, we revised § 1.640(c) to apply to accredited third -party 
certification bodies that are comprised of a single individual, as applicable.  
(Comment  89) Some comments suggest that FDA should require third -party certification 
bodies conducting regulatory audits to be accredited to eit her:  (1) ISO 17021:2011 (Ref. 6), with 
the complementary requirements of ISO/TS 22003:2007, Food safety management systems --
Requirements for bodies providing audit and certification of food safety management systems  
(Ref. 20) or (2) ISO 17065:20 12 (Ref. 7), with c onformance to ISO 1702 1:2011  (Ref. 6) and ISO 
2200 0:2005, Food safety management systems --Requirements for any organization in the food 
chain  (Ref. 21).   
Other comments suggest  that ISO/IEC 17000:2004 (Ref. 4) and ISO/IEC 17021:2011 
(Ref. 6) provide a common framework for managing the effectiveness of third -party certification 
activities and recommend incorporating the standards by reference into the final rule.  The 
comments assert that FDA’s proposed rule, by failing to incorporate by reference the ISO 
standards, appears to unnecessarily establish a unique standard in contravention of the NTTAA  
and OMB Circular A -119 ( 63 FR 8546 ) without adequate justification.  The comments include 
recommended revisions to § 1.640.  Other comments note tha t ISO/IEC Guide 65:1996 (Ref. 9) 
will be phased out by September 2015; therefore, the wording in the final rule should be changed 
to reflect the successor stan dard, ISO/IEC 17065:2012 (Ref. 7).  Some comments express 
concern about the additional costs to exporters from third -party audits and private interests over 
and above official systems.  
(Response  89)  As explained in section I.D., we have revised the rule to allow a third -
party certification body to offer documentation of conformanc e to ISO/IEC 17021:2011 (Ref. 6) 
or ISO/IEC 17065:20 13 (Ref. 7) in support of its application for accreditation, supplemented as 132 
necessary.  However, we decline the suggestion to incorporate the standards by reference into 
this rule. 
ISO/IEC ISO 17021:2011 (Ref. 6) and ISO/IEC 17065:2012 (Ref. 7), the succe ssor to 
ISO Guide 65:1996 (Ref. 9), contain requirements that are inconsistent with section 808 of the 
FD&C Act and impractical for our program.  For example, ISO/IEC 17021:2011 (Ref. 6), clause 
5.2.6, prohibits a certification body, including a governmental certification body, from providing 
internal audits to its certified clients.  Under this same clause, a certification body that has 
provided internal auditing services to a client mu st wait for 2 years before conducting an audit 
for certification purposes.  Clause 5.2.5 of the standard also prohibits the certification body from 
offering or providing any management systems consultancy (defined as participation in 
designing, implementin g, or maintaining a management system).  We note that ISO/IEC 
17065:2012 (Ref. 7), clause 4 contains similar requirements, e.g., in clauses 4.2.6 and 4.2.10 
NOTE 1, as the requirements of clauses 5.2.5 and 5.2.6 of ISO/IEC 17011:2004 (Ref. 5).  
The require ments of our third -party program are markedly different, because section 808 
of the FD&C Act expressly allows an accredited third -party certification body to conduct both 
regulatory audits for certification purposes and consultative audits for internal pur poses.  Further, 
section 808(c)(4)(C) of the FD&C Act allows an accredited certification body to use the same 
audit agent in auditing the same eligible entity, subject only to a limitation (that FDA may 
waive) on using the agent for a regulatory audit when  the agent had conducted a consultative 
audit of the eligible entity in the preceding 13 months.   
As another example, we note that ISO/IEC 17021:20 11, clauses 6.2.1  to 6.2.3 (Ref. 6), 
require a certification body  to establish an external committee for saf eguarding impartiality that 
includes representation of key interests, such as audited firms.  Clause 5.3.2 of the standard 133 
requires the certification body  to demonstrate to the external committee that commercial, 
financial, or other pressures do not compro mise its impartiality.  Under clause 6.2.2(c), the 
committee has the right to take “independent action” if the top management of the certification 
body “does not respect the advice of this committee.”  ISO/IEC 17065:2012 (Ref. 7), clause 5, 
contains simila r requirements --e.g., clause 5.2.1 NOTE 1 (committee) and 5.2.3 (right to take 
independent action).   
It would be inappropriate and impractical for FDA to require an accredited third -party 
certification body to assemble a committee representing interests o utside those of this program, 
and would be impractical for FDA to properly manage the program under such circumstances.  
We also are concerned about the disincentive these requirements of ISO/IEC 17011:2004 (Ref. 
5) and ISO/IEC 17065:2012 (Ref. 7) might create, for example, for foreign competent authorities 
who have their own processes for stakeholder engagement.  
Based on our review of the standard and explained in the examples provided above, we 
have determined that ISO/IEC 17011 :2004 (Ref. 5) and ISO/IE C 17065:2012 (Ref. 7) are 
inconsistent with section 808 of the FD&C Act and impractical for purposes of this program and 
therefore deny the suggestion to incorporate by reference into this rule.  
With respect to the suggestion to incorporate ISO/IEC 17000:2 004 (Ref. 4) into this rule, 
we note that this standard uses terminology that is inconsistent with section 808 of the FD&C 
Act.  We are concerned that incorporating the terms used in ISO/IEC 17000:2004 (Ref. 4) in this 
rule would create unnecessary confusi on as to how the rule relates to the statute.  For example, 
clause 7.5 of the standard uses the term “recognition” for the “acknowledgement of the validity 
of a conformity assessment result provided by another person or body,” while recognition is used 134 
in section 808 of the FD&C Act when describing FDA’s determination that an accreditation 
body meets the requirements of this rule.  
Based on our review of the standard and explained in the example provided above, we 
have determined that ISO/IEC 17000 :2004 (Re f. 4) is inappropriate for incorporation by 
reference into this rule.   
Although we decline to incorporate the standards mentioned in the comments, we are 
revising § 1.640 to allow a third -party certification body  to offer documentation of its 
conformance t o ISO/IEC 17021:2011 (Ref. 6) or ISO/IEC 1706 5: 2013 (Ref. 7), supplemented as 
necessary, in support of its application for accreditation under the final rule.  We conclude that 
this will serve to promote international consistency and allow third -party certification bodies to 
use a framework that is familiar to them when it can be used to meet the requirements of this 
rule. 
(Comment  90)  Some comments suggest the rule should impose different requirements on 
foreign government certification bodie s and on other third -party certification bodies  (i.e., foreign 
cooperatives and other third -party certification bodies ), because of the different nature of private 
operators and public administration.  
(Response  90)  Under section 808(a)(3) of the FD&C Act  third -party certification bodies 
include  Foreign government certification bodies, foreign cooperatives, and other third -party 
certification bodies.  Section 808 of the FD&C Act for the most part does not distinguish 
between public and private certification bodie s and states that both are subject to the same model 
accreditation standards discussed in 808(b)(2).  The only difference in treatment of public and 
private certification bodies is set forth in section 808(c)(1) of the FD&C Act, describing what 
elements of  oversight be assessed for accreditation.  This difference is reflected in the eligibility 135 
criteria set forth in in §  1.640(b) and (c).   In all other areas, we decline the suggestion to impose 
different requirements on foreign government certification bodi es and other th ird-party 
certification bodies.  
(Comment  91)  Some comments express skepticism about private auditing companies.  
Some comments note that foreign cooperatives have rarely if ever been engaged in true 
accredited third -party  auditing/certification activities and are thus unproven in that role.   
(Response  91)  As stated above, section 808 of the FD&C Act expressly provides for 
both public and private accredited third -party  certification bodies.  FDA believes the system of 
oversight established under this rulemaking will be sufficient to ensure the reliability of private 
certification bodies that are able to participate in the program.  Foreign cooperatives are 
specifically listed in section 808 of the FD&C Act as a third party  that could be a certification 
body, and must meet the same rigorous criteria to qualify for accreditation.  
B. What Legal Authority Must a Third -Party Certification Body Have to Qualify  for 
Accreditation ? (§ 1.641)  
Proposed § 1.641 would require third -party certification bodies to demonstrate that they 
have adequate legal authority, which may include authority established by contract or as a 
government entity to evaluate eligible entities for compliance with the applicable requirements of 
the FD&C Act and F DA regulations.   
FDA received no adverse comments specific to this section.  However, a s discussed in 
Response 27, we have revised § 1.641 to specify that a third -party certification body has to be a 
legal entity.   136 
C.  What Competency  and Capacity Must a Third -Party Certification Body Have to Qualify  for 
Accreditation ? (§ 1.642)  
Proposed § 1.642 would require a third -party certification body to demonstrate it has 
adequate resources to fully implement its auditing and certification program and the capacit y to 
implement the requirements of this program, if accredited.  
(Comment  92)  Some comments suggest that we require certification bodies to be 
bonded, to cover any Agency  costs should the firm go bankrupt.  
(Response  92)  We decline the suggestion to requi re certification bodies to be bonded to 
cover any Agency  costs if a certification body goes bankrupt.  This requirement is unnecessary 
because the program is designed to operate using user fees.  Additionally, § 1.642 of the final 
rule requires a third -party certification body to demonstrate that it has adequate resources to fully 
implement its auditing and certification program.   
(Comment  93)  Some comments recommend that we clearly define the necessary 
competencies of certification body staff and auditor s.  Some comments suggest that we require 
auditors to have at least 1 year of work experience in testing and assessing the conditions for 
food safety of certain food manufacturer(s) and to have attended at least 20 audits for 
management systems using hazar ds analysis and critical control point requirements.  
(Response  93)  Section 1.640  of this rule establishes the eligibility requirements for third -
party certification bodies seeking to participate in the third -party certification program.  Specific 
recommen dations on qualifications such as the years and types of work experience in food safety 
and in conducting audits will be contained in FDA’s Model Accreditation Standards final 
guidance, as explained in section I.D.  137 
(Comment  94)  Some comments emphasize the importance of having certification bodies 
accredited to the specific areas in which they will be conducting audits and issuing certifications.  
The comment explains that accredited auditors/certification bodies auditing pet f ood facilities 
must be adequately qualified and knowledgeable in pet food requirements.  The comments 
express concern that human food standards might be misapplied to a facility producing raw 
materials, ingredients or finished food for pet food (e.g., cros s-contact for allergens, ingredients 
destined for further processing).  
(Response 94)  A recognized accreditation body assessing a certification body for 
accreditation (or FDA under direct accreditation) must ensure that the certification body is 
qualified  to conduct audits under the food safety requirements of the FD&C Act and FDA 
regulations that apply to the scope of accreditation sought.  Therefore, a third -party certification 
body that is accredited to conduct audits under  part 117 would not be accred ited to perform 
audits under 21 CFR part 507, unless the accrediting body has assessed the certification body’s 
qualifications and accredited it to perform audits under part 507 as well.  
D.  What Protections Against Conflict Interest Must a Third -Party Ce rtification Body Have to 
Qualify  for Accreditation ? (§ 1.643)  
Proposed § 1.643 would require third -party certification bodies to have established 
programs to safeguard against conflicts of interest that might compromise their objectivity and 
independence.   
On our own initiative, we are clarifying in § 1.643(a) that the conflict of interest 
provisions of this section apply to officers, employees , and other agents that are involved in 
auditing and certification activities, as relevant. We are making corresponding changes in the 
subsequent provisions for accredited third -party  certification bodies under § 1.657(a) and (c).  138 
(Comment  95)  Some commen ts recommend that FDA ensure that auditors are competent 
and accountable and that there are adequate protections against conflicts of interest, with 
maximum transparency related to auditors’ activities.  The comments support requirements for 
documented saf eguards against conflicts of interest to help ensure that decisions are accurate and 
unbiased and that auditors are independent.   
(Response 95)  We agree and are requiring third -party certification bodies seeking 
accreditation to demonstrate they have wri tten conflict of interest measures and that they have 
the capacity to meet the requirements of the final rule, if accredited.  
E.  What Quality Assurance Procedures Must a Third -Party Certification Body Have to Qualify  
for Accreditation ? (§ 1.644)  
Proposed § 1.644 would require a third -party certification body to have a written program 
for monitoring and assessing its performance, identifying deficiencies in its program or 
performance and quickly executing corrective actions.   
FDA received no adverse comment s specific to this section.  However, a s discussed in 
Response 32, we revised § 1.644(a) to clarify that a certification body must demonstrate that it 
has procedures to identify deficiencies and procedures to execute corrective actions for such 
deficiencies, which would better align with international standards (see, e.g., clause 5 .5 in 
ISO/IEC 17011:2004 (Ref. 5)).  
F.  What Records Procedures Must a Third -Party Certification Body Have to Qualify  for 
Accreditation ? (§ 1.645)  
Proposed § 1.645 wou ld require a third -party certification body to have developed and 
implemented written procedures to establish, control, and retain the records.  Such records are 139 
necessary to provide the recognized accreditation body  (or FDA under direct accreditation) an 
adequate basis for assessing the certification body for accreditation under this program.    
We received no  adverse  comments specific to § 1.645 and are making no substantive 
revisions to this section.  
IX. Comments on Requirements for Third -Party Certificat ion Bodies That Have Been Accredited 
Under this Subpart  
A.  How Must  an Accredited Third -Party Certification Body Ensure its Audit Agents Are 
Competent and Objective ? (§ 1.650 )  
Proposed § 1.650 would require an accredited third -party certification body that uses 
audit agents to ensure that each audit agent meets certain requirements for competency and 
objectivity under the final rule.  Under paragraph (a), the audit agent would n eed to have 
knowledge and experience relevant to determining an eligible entity’s compliance with the 
applicable food safety requirements of the FD&C Act and FDA regulations and, for consultative 
audits, conformance with industry standards and practices.  The accredited certification body 
would have to determine the audit agent’s competency to conduct food safety audits in part by 
observing a representative number of audits performed by the audit agent.  The audit agent 
would have to complete annual food sa fety training under the accredited third -party certification 
body’s training plan, comply with the conflict of interest requirements for audit agents, and agree 
to notify its certification body immediately upon discovering, during a food safety audit, any 
condition that could cause or contribute to a serious risk to the public health.   
Under proposed § 1.650(b), the accredited third -party certification body would have to 
assign an audit agent qualified to conduct the food safety audit, based on the scope a nd purpose 
of the audit and the type of facility, its processes, and food.  Proposed § 1.650(c) would prevent 140 
an accredited third -party certification body from using an audit agent to conduct a regulatory 
audit of an eligible entity if the agent had conduc ted a regulatory or consultative audit of the 
same eligible entity during the preceding 13 months, except FDA could waive the 13 -month 
limitation for an accredited certification body that could demonstrate insufficient access to 
accredited third -party cert ification bodies in the country or region where the eligible entity is 
located.   
Of our own initiative, we are revising § 1.650(a) to apply to accredited third -party 
certification bodies that are comprised of a single individual, as applicable.  Section 8 08(a)(3) of 
the FD&C Act specifically allows an accredited third -party certification body to be an individual, 
which would not fall within the definition of “audit agent” in the statute or this rule.  Therefore, 
as part of establishing eligibility under § 1.640, an individual seeking accreditation must fulfill 
the requirements of § 1.650(a)(1) to become accredited under this rule and, once accredited, must 
comply with the annual food safety training requirements of § 1.650(a)(3).  Pursuant to § 
1.650(a)(4),  an accredited third -party certification body also must comply with the conflict of 
interest provisions applicable to audit agents under § 1.657(a)(3).  
We note that a recognized accreditation body that is assessing an individual seeking 
accreditation under  this program also must assess the individual’s knowledge and experience 
under § 1.650(a)(1) for the scope of accreditation requested and must consider the results of such 
assessment in determining the individual’s eligibility for accreditation under § 1.6 40.  The onsite 
observations of an individual seeking accreditation that are performed under § 1.620(a)(3) must 
be sufficient to determine competency consistent with § 1.650(a)(2).  
(Comment  96)  Some comments strongly support the proposed requirements of § 1.650, 
which would require an accredited certification body to ensure that the audit agents it uses have 141 
the knowledge and experience, within the scope of its accreditation, to examine facilities, 
processes, and foods for compliance with the FD&C Act and  FDA regulations.  The comments 
assert that audits are only as good as the education, training, and experience of the auditor.  Other 
comments recommend that food safety audits under this rule should be performed by individuals 
that have training equivalen t to FDA investigator training standards.   
(Response  96)  We agree with comments emphasizing the importance of ensuring that 
audit agents an accredited third -party certification body uses to conduct audits under the program 
are appropriately qualified wit hin the scope of the third -party certification body’s accreditation.  
Proposed § 1.650 would comprise the elements of a comprehensive assessment that an accredited 
third -party certification body would need to perform for each audit agent it would use to co nduct 
a food safety audit under this rule.  We further agree with comments suggesting that an auditor 
determined by a third -party certification body to be competent to conduct audits under private 
food safety schemes must nonetheless be assessed by the acc redited third -party certification body 
for competency to conduct audits using the applicable food safety requirements of the FD&C Act 
and FDA regulations as the audit criteria .  Therefore, under § 1.650(a), an audit agent would 
need to demonstrate substant ive knowledge of the applicable food safety requirements of the 
FD&C Act and FDA regulations relevant to the scope and purpose of the food safety audits the 
agent would conduct under the program.  We do not agree to go so far as to require that all audit 
agents or individuals accredited as third -party certification bodies must have training equivalent 
to FDA investigator training standards, as we acknowledge that some investigator training would 
not be necessary to conduct audits under this program (e.g., e vidence colle ction for enforcement 
purposes) .  Such a requirement would impose unnecessary costs and might serve as a 
disincentive to participation in the program.  142 
(Comment  97)  Some comments specifically endorse proposed § 1.650(a)(2), which 
would require  each audit agent to be observed conducting audits to examine compliance with the 
FD&C Act in a representative number of facilities and foods.  Other comments recommend that 
an accredited third -party certification body should observe an audit agent before the agent begins 
to conduct food safety audits of a different type of food, followed by random, periodic spot 
audits to confirm that the audit agent is applying the audit criteria consistently.  The comments 
interpret proposed § 1.650(a)(2) to mean that th e accredited third -party certification bodies 
would be required to “continually witness” each audit agent they use.  
(Response  97)  We agree that observations of audit agents under proposed § 1.650(a)(2) 
are essential in determining the competency of audit agents.  We are revising proposed 
§ 1.650(a)(2) to require the observation of a representative “sample” of audits, instead of a 
representative “number” of audits, because the focus of this provision was not intended to be on 
the number of audits the audit agents would be expected to conducted.  Rather, we intend for the 
accredited third -party certification body to observe a sample of audits that are representative of 
the range of audits the audit agent might be assigned.  
In determining what would constitut e a “representative sample” for purposes of final 
§ 1.650(a)(2), the accredited third -party certification body should consider the various types of 
food facilities that might be audited and the range of FDA regulations that would apply to such 
facilities.  An accredited third -party certification body would need to observe the audit agent 
conducting a number of audits across the range of facilities identified by the certification body, 
and the range of FDA regulations that would apply to those facilities, su ch that, taken together, 
the observed audits would be adequately representative of the facilities, processes, and foods the 
audit agent may be assigned to conduct.  Generally, the more complex the regulations or the 143 
more complex the processes used by the facility, the greater the sample size should be, to help 
ensure the audit agent can apply the audit criteria consistently and reliably in various situations.  
The accredited third -party certification also should gather sufficient information to provide 
confidence in its determination of the audit agent’s competency to conduct audits under this rule.  
Contrary to the interpretation suggested by some comments, proposed § 1.650(a)(2) 
would not require an accredited third -party certification body to “continually  witness” each of its 
audit agents.  Such an approach is not practical, efficient, or necessary.  However, w e are 
clarifying in § 1.650(a)(2) that before an audit agent is used to conduct food safety audits under 
this rule the audit  agent must  be observed  by the  accredited  third -party certification body and  
found to be competent to conduct food safety audits relevant to the audits they will be assigned 
to perform under this program.   Such observations also must be performed whenever an audit 
agent will be a ssigned to perform food safety audits to determine compliance with additional 
food safety requirements under the FD&C Act and FDA regulations  beyond what the 
certification body has previously observed . 
Under this approach, o nce an accredited third -party ce rtification body has determined an 
audit agent’s competency and objectivity under § 1.650, the audit agent can be assigned to 
conduct audits for which they are qualified under § 1.650(a)(1) and (2) , subject to requirements 
such as the annual training requi rements in §  1.650(a)(3) and the accredited third -party 
certification body’s self -assessment under §1.655.  Although we decline to require periodic 
observations of audit agents, once the accredited certification body has determined the 
competency of its au dit agents under § 1.650(a)(2), we acknowledge the value of such 
observations in verifying audit agent competency and the rigor of the certification body’s 
program for evaluating its audit agents.  144 
(Comment ) 98)  Some comments recommend that we include requirements focusing on 
the performance of individual audit agents because, the comments assert, many audit complaints 
arise from individual auditor conduct and focusing on individual performance may help create 
more consistency in the process.  
(Response  98)  We agree, and have received similar input from other stakeholders during 
our public meetings.  The comments and other stakeholder input underscore the importance of 
the requirements for an accredited third -party certification body to observe a representative 
sample of audits conducted by each audit agent under § 1.650(a)(2), to ensure that any audit 
agent it assigns to an audit is appropriately qualified under § 1.650(b), and to assess the 
performance of its audit agents and the consistency of performance across all its audit agents as 
part of the certification body’s self -assessment under § 1.655.  
(Comment  99)  Some comments support the proposed requirement for annual food safety 
training under proposed § 1.6 50(a)(3), noting the importance of ensuring that audit agents have 
up-to-date training in areas relevant to their audit activities.  The comments also suggest that 
FDA should communicate to training institutions any general audit agent training needs FDA 
identifies through its program management and oversight.  Other comments recommend that the 
annual training requirement should relate to relevant food safety provisions of the FD&C Act 
and FDA regulations.  
(Response  99)  We agree and are revising § 1.650(a) (3) to clarify that an audit agent, or 
an individual accredited as a third -party certification body, must have annual food safety training 
that is relevant to activities conducted under this program.  FDA works with a number of 
Alliances and other organiza tions to ensure  training needs for  regulatory requirements are met. 
For instance, having identified the need to train regulators and industry in the new FSMA 145 
preventive controls rules, FDA is working in collaboration with the Food Safety Preventive 
Control s Alliance (FSPCA) to develop training materials and establish training and technical 
assistance programs for the preventive controls rules.  The Alliance includes members from 
FDA, state food protection agencies, the food industry, and academia and is fun ded by a grant to 
the Illinois Institute of Technology’s Institute for Food Safety and Health.  For more i nformation 
about the FSPCA, see  e.g., http://www.iit.edu/ifsh/alliance/. http://www.iit.edu/ifsh/alliance/ . 
(Comment  100)  Some comments suggest that i n addition to the requirements of the 
proposed rule, we should require conformance to ISO/IEC 19011:2011 (Ref. 8) on auditor 
competency.   
(Response  100)  FDA’s recommendations on auditor competency, among other things, 
will be contained in FDA’s Model Accreditation Standards.  As noted in section I.D., comments 
that address matters covered by FDA’s Model Accreditation Standards are outside the scope of 
this rulemaking.   
The issuance of the Model Accreditation Standards draft guidance was announced 
through publication of a notice of availability in the Federal Register  of July 24, 2015 .  We plan 
to finalize the Model Accreditation Standards after receivin g public comments on the draft 
guidance.  
(Comment  101)  Some comments note that the audit agent’s education, training, and 
experience must be specific to the industry or industries being audited.  Some comments, for 
example, recommend that audit agents wh o examine eligible entities for compliance with food 
additive requirements should have industry experience with food additives and relevant 
knowledge, experience or training in auditing these types of facilities and processes.   146 
(Response  101)  We agree th at a certification body must consider an audit agent’s 
competency whenever assigning the audit agent to a specific audit.  Therefore, § 1.650(b) 
requires the accredited third -party certification body to ensure that an audit agent it assigns to a 
specific a udit is appropriately qualified, based on the audit scope and purpose, the specific type 
of facility, processes, and foods the audit agent would be required to examine, and the food 
safety requirements of the FD&C Act and FDA regulations that would apply.  
We note that an accredited third -party certification body that is an individual would be 
determined during the accreditation process to be appropriately qualified to conduct audits within 
the scope of its accreditation.  
(Comment  102)  Some comments agree with proposed § 1.650(c) and assert that it is 
needed to protect against conflicts of interest.  Some comments assert that, under current 
practices, auditors in many countries frequently conduct consecutive audits at the same premises.  
Other comments suggest that the 13 -month limit is unnecessary because adequate mechanisms 
already exist to manage conflicts of interest and objectivity in ISO/IEC standards.  Still other 
comments express concern that the proposed limit of 13 months would be too short to avoid a 
conflict of interest.  These comments contend a short interval between consultative audits and 
regulatory audits that are conducted by the same audit agent could create the appearance that the 
audit agent is auditing the results of the prior consultation.  Other comments assert we should 
impose a 2 -year limit, rather than a 13 -month limit on audit agents conducting regulatory audits 
of the same eligible entity.  
(Response  102)  We disagree with comments opposed to proposed § 1.650(c).   Proposed 
§ 1.650(c) would implement the requirements of section 808(c)(4)(C) of the FD&C Act, which 
limits an accredited third -party certification body’s ability to use an audit agent to conduct a 147 
regulatory audit of an eligible entity if the agent condu cted a consultative or regulatory audit for 
the same eligible entity in the preceding 13 months, unless FDA waives the limitation under 
criteria described in the statute.  While we recognize this requirement may differ from some 
international standards, it  balances the concern of an audit agent auditing their own prior results 
if the subsequent audit happens too soon with auditor capacity concerns through a waiver 
provision.  Under proposed § 1.663, FDA would issue waivers where we determine there is 
insuff icient access to in the country or region where the eligible entity is located.  
We note that the proposed rule was unclear with respect to whether the showing of 
insufficient access to support a waiver was based on a lack of certification bodies or indivi dual 
audit agents in a country or region, and have therefore clarified in the final rule that the showing 
of insufficient access necessary for FDA to grant a waiver request is based on lack of audit 
agents (or in cases where individuals are accredited as t hird-party certification bodies , those 
individuals).  Although we are finalizing additional conflict of interest requirements in § 1.657 of 
this rule, these provisions do not implement the 13 -month limit in section 808(c)(4) of the FD&C 
Act.  Section § 1.6 50(c) complements the requirements in § 1.657 to provide additional conflict 
of interest protections.  Note that though this response uses the term “audit agent” this provision 
also applies to accredited third -party certification bodies that are individual s. 
(Comment  103)  Several comments assert that proposed § 1.650(c) and the waiver 
process FDA proposes to establish would be impractical.  The comments note that there is 
currently a significant shortage of experienced food safety auditors around the world.  Describing 
it as a “capacity” issue, the comments suggest that implementation of the FSMA rules will 
further exacerbate the problem.  Some comments suggest that proposed § 1.650(c) would be 
impractical for small countries due to auditor capacity issues.  148 
(Response  103)  We acknowledge the concerns about the possible shortage of skilled 
food safety auditors to meet current global demand and are aware of efforts by GFSI, the food 
industry, scheme owners, and third -party food safety certification bodies to address auditor 
capacity , as described in section I.D .  We also understand that FSMA implementation is likely to 
create further demand for auditors.  Nonetheless, as explained in Response 10 2, we are required 
by section 808(c)(4)(C) of the FD&C Act to limit an accredited th ird-party certification body’s 
ability to use an audit agent; we have clarified in the final rule that the showing of insufficient 
access necessary for FDA to grant a waiver request is based on lack of audit agents (or in cases 
where individuals are accred ited as third -party certification bodies, those individuals).  
We disagree with comments suggesting that the waiver process we propose would be 
impractical.  We are developing an IT portal that includes the capability for accepting electronic 
submissions of  requests and electronic issuance of waivers, which will help facilitate the 
submission of waiver requests by accredited third -party certification bodies and FDA’s 
processing of such requests.  
(Comment  104)  Some comments contend that the proposal to requ ire accredited third -
party certification bodies to show insufficient accredited third -party certification body resources 
to obtain an FDA waiver of proposed § 1.650(c) would be unnecessarily burdensome because the 
proposed conflict of interest requirements  adequately protect against concerns about “industry 
capture.”  Some comments recommend that FDA research global food safety auditor capacity 
and proactively issue waivers of proposed § 1.650(c), absent waiver request(s).  Still other 
comments suggest that  eligible entities should be able to seek waivers of the 13 -month limit on 
behalf of an accredited third -party certification body.  149 
(Response  104)  Under section 808(c)(4)(C) of the FD&C Act, the 13 -month limit on 
audit agents conducting regulatory audits m ay be waived if FDA determines there is insufficient 
access to audit agents in a country or region.  While acknowledging capacity concerns raised in 
comments, we decline the suggestion that FDA should gather information to support waivers 
absent a request for a waiver under section 808(c)(4)(C)(ii) of the FD&C Act.  We believe 
gathering such information would not be the best use of our limited resources, and that third -
party certification bodies would be better positioned to inform FDA of audit agent capaci ty 
issues in their country or region of operation.   Moreover, the final rule clarifies that accredited 
third -party certification bodies must demonstrate that there is insufficient access to audit agents 
in the country or region where the eligible entity is  located in order to obtain a waiver.  Because 
the 13 -month limit is on individual audit agents, and not third -party certification bodies, this 
limitation is likely to be less burdensome than anticipated by the comments.  
We decline the suggestion to allow eligible entities to request a waiver of proposed 
§ 1.650(c) on behalf of an accredited third -party certification body, because we believe the 
accredited third -party certification body will be better suited to assess auditor capacity on a 
national or regio nal basis.  Periodic rotation of audit agents is intended to help ensure that audits 
remain objective and do not become compromised by familiarity.  The requirement to ensure an 
audit agent’s objectivity is placed on the accredited third -party certificatio n body, not an eligible 
entity, under proposed § 1.650(a).  Further, given that the accredited third -party certification 
body would ultimately need to agree to conduct an audit for an eligible entity, requiring the 
accredited third -party certification body  to request the waiver would ensure that they are willing 
to accept the request for a food safety audit in the first place.  In light of the foregoing, we have 150 
concluded that it is the accredited third -party certification body, not the eligible entity, who  
should seek a waiver of the 13 -month limit in proposed § 1.650(c).  
We disagree with comments suggesting waiver requests will be unduly burdensome or 
time-consuming for accredited third -party certification bodies.  The IT portal we are developing 
for the third -party certification program includes the capability for accepting electronic 
submissions of requests and electronic issuance of waivers, which we believe will help minimize 
the administrative burden on certification bodies and FDA.   
B.  How Must an Accredited Third -Party Certification Body Conduct a Food Safety Audit of an 
Eligible Entity ? (§ 1.651)  
Proposed § 1.651 would establish requirements for planning and conducting consultative 
and regulatory audits in a manner that fulfills the purposes of section 808 of the FD&C Act.  
Under paragraph (a) on audit planning, the accredited third -party certifica tion body would 
require the eligible entity to identify whether it was seeking a consultative or regulatory audit 
subject to the requirements of this subpart  under the third -party certification program.  The 
eligible entity would indicate the scope and pur pose of the requested audit and, in the case of a 
regulatory audit, would indicate the type of certification sought.  The accredited third -party 
certification body would also require the eligible entity to provide a 30 -day operating schedule 
for the facili ty that would provide information relevant to scope and purpose of the audit.  The 
accredited third -party certification body would then consider whether the requested audit is 
within the scope of its accreditation.  
Proposed § 1.651(b) would require the acc redited third -party certification body to ensure 
it would have adequate authority to conduct the requested audit, including authority to:  (1) 
Conduct an unannounced audit; (2) access any area of the facility or any of its records relevant to 151 
the scope of the audit; (3) use an accredited laboratory in accordance with section 422 of the 
FD&C Act , (21 U.S.C. 350k) , where FDA requires sampling and analysis; (4) notify FDA 
immediately upon discovering, during a consultative or regulatory audit, a condition that  could 
cause or contribute to a serious risk to the public health; (5) prepare audit reports that would 
contain certain elements and, for regulatory audits, that would be submitted to FDA; and (6) 
allow FDA and its recognized accreditation body to observe any food safety audit under the 
program.  
Proposed § 1.651(c) would require an unannounced audit to be conducted in a manner 
consistent with its scope and purpose and would include records review as well as an onsite 
examination of the facility, process(es) , and food to determine compliance with the applicable food 
safety requirements of the FD&C Act and FDA regulations, and for consultative audits, 
conformance with include industry standards and practices.  Proposed § 1.651(c) would require the 
audit agent to document observations and corrective actions and, where appropriate, would include 
environmental or product sampling and analysis using validated methodologies and a laboratory 
accredited in accordance with the requirements of section 422 of the FD&C Ac t.  
At our own initiative, we are removing the requirement to use a laboratory consistent with 
section 422 of the FD&C Act and inserting a requirement in § 1.651(b)(3) to use a laboratory 
accredited under ISO/IEC 17025:2005 or another laboratory accreditat ion standard that provides at 
least a similar level of assurance in the validity and reliability of sampling methodologies, 
analytical methodologies, and analytical results . 
On our own initiative, we are also revising § 1.651(c)(1) to clarify that the audi t must be 
focused on determining whether the facility, its process(es), and food are in compliance with the 
applicable food safety requirements of the FD&C Act and FDA regulations, and for consultative 152 
audits, also includes conformance with applicable indu stry standards and practices.   Based on  
comments received on § 1.653 and for the reasons described in Comment/Response  112 in 
section IX.C., we are revising  § 1.651(c)(3) to clarify that an accredited third -party certification 
body (or its audit agent, wh ere applicable) that identifies a deficiency requiring corrective action 
may verify the effectiveness of a corrective action once implemented by the eligible entity but 
must not recommend or provide input to the eligible entity in identifying, selecting, o r 
implementing the corrective action.    
(Comment  105)  Some c omments suggest that we should incorporate ISO/IEC 
19011:2011 (Ref. 8), which contains guidelines on auditing management systems, by reference 
into the rule.   
(Response  105)  We disagree, because ISO/IEC 19011:2011 (Ref. 8) is inconsistent with 
the requirements of section 808 of the FD&C Act and this rule.  For example, ISO/IEC 
19011:2011 (Ref. 8) is premised on announced audits that are scheduled with the client, as 
describ ed in clauses 6.2.2, and 6.2.3 of the standard; however, section 808(c)(5)(C)(i) of the 
FD&C Act requires audits conducted under this rule to be unannounced.  As another example, 
clause 6.4.9 of ISO/IEC 19011:2011 (Ref. 8) suggests that an audit team shoul d attempt to 
resolve any “diverging opinions” between the team and the audited entity regarding the audit 
conclusions, such as the extent of conformity with audit criteria (clause 6.4.8), during the closing 
meeting.  We acknowledge that differences of opin ions regarding audit conclusions are likely to 
occur between eligible entities and accredited third -party certification bodies or audit agents.  
However, the credibility of our program rests in large part on the independence and objectivity of 
accredited t hird-party certification bodies and audit agents.  This rule is intended to help ensure 
they are free from the influence of the eligible entities and any appearance that their judgment is 153 
compromised by eligible entities.  Audit conclusions regarding an el igible entity’s compliance 
with the applicable food safety requirements of the FD&C Act and FDA regulations are the 
purview of the accredited third -party certification body and any audit agents it uses.  The 
appropriate mechanism for an eligible entity see king to challenge adverse decisions would be the 
accredited third -party certification body’s appeals process.   
For the foregoing reasons, we decline to incorporate ISO/IEC 19011: 2011  (Ref. 8) by 
reference into this rule.   
(Comment  106) Some c omments asse rt the guidelines for management systems auditing 
in ISO/IEC 19011:2011 (Ref. 8) would provide a useful guide for audits conducted under the 
program.  Other comments suggest the audit agents should be conducting food safety audits 
using a quality systems a pproach.  Citing the production of food additives as an example, these 
comments note that while it would be preferable to conduct an audit while a food additive is 
being produced it is not always feasible.  The comments suggest that as long as the audit fo cuses 
on quality systems it should not be necessary for production of the food additive to occur during 
the audit.  
(Response  106)  As explained in Response 105, some elements of ISO/IEC 19011:2011 
(Ref. 8) are inconsistent with the requirements of section 808 of the FD&C Act and this rule, 
thereby limiting its applicability for food safety audits conducted under this rule.  We agree , 
however,  with the general principle that a “systems ” approach to food saf ety audit s with a 
correctly identified scope and purpose, using appropriate audit criteria, and properly executed by 
a competent audit agent (or individual accredited as third -party certification body), should be 
sufficient to cover the food within the aud ited system (s) of the facility, without requiring direct 
observation of each type of food produced.  We note that it is essential that the scope of the audit 154 
covers the appropriate physical locations, activities, and processes that are part of the 
manageme nt system to be audited, and information collected during the audit must be relevant to 
the audit scope, purpose, and criteria, including information relating to interfaces between 
functions, activities, and processes of the food safety system.    
We use th e term “systems audits” generally, acknowledging that “management systems” 
audits, “product certification” audits, and “quality systems” audits have specific meanings in 
some contexts, such as ISO/IEC standards, but may have different meanings in different  
contexts.  To the extent that the comments referencing a “quality systems” approach are 
suggesting that food safety audits should be conducted using a “systems  auditing”  approach, we 
agree.  Accordingly, we are revising § 1.651(c)(1) to better align with the language of section 
808 of the FD&C Act and this rule, as well as “systems ” auditing principles.  
Our goal is to ensure the rigor of the food safety audits conducted under our program, 
which will be accomplished through compliance with the requirements of this rule.   It is intended 
to help ensure that food safety audits  are conducted by competent audit agents (or individuals 
accredited as a third -party certification bodies), in accordance with a properly defined audit 
scope and purpose, using the applica ble audit criteria required by this rule.  As such, any food 
safety audit conducted under the rule should provide the information necessary for the accredited 
third -party certification body to make a determination on compliance with the applicable food 
safety requirements of the FD&C Act and FDA regulations.  Whether or not a particular audit 
does, in fact, provide such information, with an appropriate level of confidence, is dependent on 
a number of factors, among them:  
1. At the time that the food safety audit is procured, the eligible entity must declare the scope 
and purpose of the audit consistent with the requirements of this rule (and any additional 155 
criteria established in VQIP guidance for facility certifications for use in that program or, for 
certifications to be used for purposes of section 801(q) of the FD&C Act any additional 
criteria that may be established by FDA relating to the safety determination).  
2. The accredited third -party certification body must assign an audit agent that is competent to 
perform the audit (or, for an accredited third -party certification body that is an individual, 
such audit must be within the scope of accreditation).   
3. The aud it agent (or individual accredited as a third -party certification body) must:  
a. Develop and successfully execute an audit plan that includes a records review, which 
may be scheduled, and a subsequent onsite facility examination performed on an 
unannounced  basis within a 30 -day window of time according to the facility’s 
operating schedule for the requested audit purpose and scope and using the 
appropriate audit criteria; and  
b. during the audit collect and verify information that is relevant to the audit pu rpose, 
scope, and criteria and that will form the basis for the audit findings and conclusions.  
We note that this rule establishes the requirements for the third -party certification 
program but does not establish requirements relating to the use of these c ertifications for 
purposes of sections 801(q) and 806 of the FD&C Act.  To that end, we urge an eligible entity 
seeking a regulatory audit for certification to be used for VQIP purposes or for purposes of 
satisfying a requirement for certification under section 801(q) to ensure that the scope of the 
regulatory audit it procures, and any food and facility certifications that are issued as a result, 
will be sufficient to meet FDA requirements under sections 801(q) and 806 of the FD&C Act.   
Under section 806 of the FD&C Act, FDA will require facility certifications issued by 
accredited third -party certification bodies under section 808 as a condition of an importer’s 156 
eligibility for VQIP.  We encourage eligible entities, importers, and accredited third -party 
certification bodies to consult the VQIP guidance, when finalized, to ensure the proper scope has 
been established for any regulatory audit conducted to obtain facility certification for VQIP 
purposes.   
Any requirement for  certification to satisfy a condit ion of admissibility under section 
801(q) of the FD&C Act would be based on an FDA safety determination relating to specific 
circumstances, as described in section 801(q)(2).  An eligible entity seeking certification from an 
accredited third -party certific ation body to meet the admissibility requirements under section 
801(q) of the FD&C Act must ensure  the proper scope has been established for the regulatory 
audit it procures to address the circumstances behind the 801(q) determination.  
(Comment  107)  Some comments assert that the audit requirements in proposed § 1.651 
are overly detailed and inflexible, contending that accreditation bodies have their own 
requirements for good auditing practices.  The comments also suggest that proposed § 1.651, 
would be problematic to implement and cite as an example the proposed requireme nt for 
unannounced audits, which the comments say would be inconsistent with the requirements 
associated with planned audi ts that apply in other programs.  
(Response  107)  We understand  that some of the requirements in proposed § 1.651 differ 
from the audit  protocols currently used in conducting many third -party audits of food facilities.  
The comments do not identify the good auditing practices they assert accreditation bodies 
already require certification bodies to use; however, we are not incorporating IS O/IEC 
17021: 2011 , ISO/IEC 17065: 2012 , or ISO/IEC 19011: 2011  by reference into this rule for the 
reasons explained in  section I.D.  We are unable to identify a voluntary consensus standard that 
would encompass the audit practices required by section 808 of the FD&C Act (e.g., 157 
unannounced audits and notification of conditions that could cause or contribute to a serious risk 
to public health) as well as other practices the statute allows (e.g., audit agents conducting both 
consultative and regulatory audits).  In the absence of existing standards that would adequately 
address the food safety audit requirements of section 808 of the FD&C Act, § 1.651 offers 
accredited third -party certification bodies and audit agents the requirements needed to conduct 
food safet y audits in the manner the statute contemplates and requires.   
The comment asserting that proposed § 1.651, would be problematic to implement cited 
as an example the proposed requirement for unannounced audits in § 1.651(c)(1).  We 
acknowledge that most a udits are scheduled, and a program involving unannounced audits will 
require changes in the current usual practices of accredited third -party certification bodies and 
eligible entities.  However, section 808(c)(5)(C)(i) of the FD&C Act specifically require s audits 
performed under this rule to be unannounced.  As described in Response 106, proposed 
§ 1.651(c)(1) was designed to provide flexibility to accredited third -party certification bodies and 
eligible entities, while fulfilling this statutory requiremen t.  Without additional examples or other 
details in the comments to explain why the other audit protocols in proposed§ 1.651(a) would be 
problematic to implement, we decline to revise § 1.651(a)(2 ) to (4) in response to the comments.   
(Comment  108)  In ad dition to comments described in section III.E. regarding the 
impracticality of unannounced audits , some comments contend that unannounced audits would 
be impractical and inefficient  for any food safety audit (e.g., regulatory audits) conducted under 
this r ule.  Other  comments express concern about implementing unannounced audits at farms 
that may be geographically isolated, while offering support for unannounced audits in principle.   
Other comments note that unannounced audits are conducted for operations participating 
in the Leafy Greens Marketing Agreements (LGMAs) in California and Arizona and in the 158 
California Cantaloupe Marketing Order (CCMO), asserting it is feasible to conduct audits of 
seasonal operations during harvest activities, observing practic es and programs in the field and 
facility.  Some comments suggest that unannounced audits provide a more realistic view of the 
entity’s compliance status than planned audits do.   
Some comments endorse the approach of a planned records review prior to an 
unscheduled site audit occurring at any point during a 30 -day operating window.  Other 
comments ask us to clarify in the final rule which parts of a food safety audit may be performed 
on a scheduled basis and which parts must be performed on an unannounced basis within a 30 -
day window.  
(Response  108)  We decline to revise our approach to unannounced audits under § 1.651, 
as section 808(c)(5)(C)(i) of the FD&C Act explicitly requires that audits be unannounced.  We 
are, however, adding language to § 1.651(c)(1) to clarify that the records review portion of a 
food safety audit may be scheduled with an eligible entity and, through revisions to  
§ 1.651(c)(2), are requiring the records review t o occur before the onsite facility examination 
portion of the audit, consistent with the description in the preamble to the proposed rule (78 FR 
45782  at 45811  to 45812).  We are retaining the requirement in § 1.651(c)(1) to conduct an 
unannounced audit th rough an unscheduled  onsite facility examination at any time during the 30 -
day timeframe identified pursuant to § 1.651(a)(1)(ii).   
As discussed in the preamble to the proposed rule  (78 FR 45782  at 45811) , when 
developing  the audit protocols to implement the statutory requirement for unannounced audits, 
we considered the British Retail Consortium (BRC) Global Standard for Food Safety (Ref. 22) 
unannounced audit option to help us ensure that our approach to unannounced audits would be 
practical and feasible  to implement.  The BRC unannounced audit option provides for a “Good 159 
Manufacturing Practices -type audit” to be unannounced, while a separate records review could 
occur during a planned visit.  We have concluded that it is reasonable and appropriate to int erpret 
the statutory requirement for unannounced audits to allow a record review to be conducted 
during a planned visit to the eligible entity, provided that the onsite audit is conducted on an 
unannounced basis.  In addition , as discussed previously,  we h ave revised § 1.651(c)(2) to 
require that the records review must precede the onsite examination to facilitate the facility visit . 
We agree with comments suggesting that unannounced audits are feasible and note, for 
example, that another GFSI -benchmarked s cheme, the Safe Quality Food Code in July 2014 
began implementing an unannounced audit component, wherein unannounced audits are 
mandatory for every third audit (Ref. 2 3).  Additionally, while we appreciate the concern 
expressed by comments regarding the implementation of unannounced audits at farms that may 
be geographically isolated, we believe the examples cited by comments of unannounced audits of 
participants that are performed at least once each year under  the LGMA and the CCMO are 
persuasive in demonstrating the feasibility of unannounced audits for primary production.  
Moreover , the requirements for audits specified in the statute and  our experiences planning 
foreign i nspections lead us to  believe that the requirement for a 30 -day operating window will 
assist in preventing logistic problems associated with unannounced audits in geographically 
isolated areas.  For the foregoing reasons, we have concluded that the unannou nced audit 
protocol in § 1.651(a)(1) is practical and efficient to implement, while meeting the requirements 
of section 808(c)(5)(C)(i) of the FD&C Act.   
(Comment  109)  Some comments suggest that FDA increase the window of time between 
the records review,  which informs the audit planning, and the unannounced site audit, which 
examines the facility, its process(es), and food for compliance with the applicable food safety 160 
requirements of the FD&C Act and FDA regulations.  To maximize the element of surprise while 
ensuring the relevance of the records review to the conduct of the site audit, the comments 
suggest we should expand the timeframe to allow the audit agent to conduct the site audit any 
time during a 90 -day period.  
(Response  109)  Food safety audits conducted under this program, particularly regulatory 
audits for certification purposes, often are time  sensitive in nature, because they are necessary for 
issuance of c ertifications that are used facilitate trade.  Establishing a lengthy window of time 
during which an unannounced audit could occur could have significant implications, for 
example, where certification is used in satisfying a condition of admissibility for a food subject 
an FDA safety determination under section 801(q) of the FD&C Act.  A len gthy window of time 
for an unannounced audit to be conducted also could hinder participation in the VQIP program 
under section 806 of the FD&C Act, which requires an importer to provide facility certification 
as a condition of participation .  In light of t he foregoing, we do not believe it would be 
reasonable to extend the length of time between records review and the site audit from 30 to 90 
days.   
C.  What Must  an Accredited Third -Party Certification Body Include in Food Safety Audit 
Reports ? (§ 1.652)  
Proposed § 1.652 would implement section 808(c)(3)(A) of the FD&C Act, which 
authorizes FDA to establish the requirements for audit reports that an accredited third -party 
certification body would need to prepare as a condition of its accreditation.  The sta tute specifies 
that such report of an audit must include:  (1) The identity of the persons at the eligible entity 
responsible for compliance with food safety requirements; (2) the dates and scope of the audit; 161 
and (3) any other information FDA requires tha t relates to or may influence an assessment of 
compliance.  
Proposed § 1.652(a) would specify the form of consultative audit reports, which would 
include:  The name, address, and unique facility identifier (UFI) of the facility subject to audit; 
the name, address, and UFI of the eligible entity (if it differs from the facility); the contact 
information for the person(s) responsible for food safety compliance at the facility; the dates and 
scope of the consultative audit; and any deficiency(ies) observed dur ing the audit that require 
corrective action(s) and the date on which such corrective action(s) were completed.  Proposed 
§ 1.652(a) would require that a consultative audit report be prepared by no later than 45 days 
after completing the audit and would re quire preparing the report in English and maintaining it as 
a record under proposed § 1.658.   
Proposed § 1.652(b) would specify the form of regulatory audit reports, which would 
include:  (1) The name, address, and UFI of the facility subject to audit; (2) the FDA food facility 
registration number (where applicable); (3) the name, address, and UFI of the eligible entity (if it 
differs from the facility); (4) the contact information for the person(s) responsible for food safety 
compliance at the facility; (5) the dates and scope of the regulatory audit;  (6) the process(es) and 
food(s) observed during the audit; (7) whether sampling and laboratory analysis is used in the 
facility; (8) recent food recalls; (9) recent significant changes at the facility; and (10) any food or 
facility certifications recently issued to the entity.  With respect to deficiencies and corrective 
actions, proposed § 1.652(b) would require the accredited third -party certification body to 
include in the regulatory audit report any defic iency(ies) observed during the audit that meet 
FDA’s Class I and  Class II recall standards --i.e., the deficiency(ies) present(s) a reasonable 
probability that the use of or exposure to the violative product will cause serious adverse health 162 
consequences o r death; or may cause temporary or medically reversible adverse health 
consequences or where the probability of serious adverse health consequences is remote,  and the 
corrective action plan for any identified deficiency unless the corrective action was im plemented 
immediately and verified onsite by the accredited third -party certification body.  Proposed § 
1.652(b) also would require that a regulatory audit report be submitted to FDA electronically, in 
English, by no later than 45 days after completing the  audit.  
Under proposed § 1.652(c), an accredited third -party certification body would have to 
submit to FDA an audit report for any regulatory audit it conducts, regardless of whether the 
certification body issued a certification based on the results of t he regulatory audit.  Proposed 
§ 1.652(d) would require an accredited third -party certification body to implement written 
procedures for receiving and addressing challenges from eligible entities contesting adverse 
regulatory audit results and would requir e them to maintain records of such challenges under 
proposed § 1.658.   
On our initiative, we revised paragraphs (a) and (b) of § 1.652 to clarify that an  
accredited third -party certification body must provide a copy of a consultative audit report or 
regul atory audit report (respectively) to the eligible entity.  We also on our own initiative added a 
requirement for the accredited third -party certification body to include in the audit report the 
FDA Establishment Identifier (FEI) of the facility audited and  the FEI of the eligible entity, if 
different than the FEI for the audited facility to help verify the identity of the facility and eligible 
entity based on information contained in FDA’s database of FEIs .  Further,  we aligned the 
elements of the consultat ive audit report and regulatory audit report; for example, we 
redesignated proposed paragraph (a)(5) as (a)(6) and added a new paragraph (a)(5) to require that 
the consultative audit report include the processes and foods observed during the consultative 163 
audit.  Additionally, on our own initiative we revised § 1.652(d) to clarify that an accredited 
third -party certification body must notify an eligible entity of a denial of certification.  
(Comment  110)  Several comments raise concerns regarding the require ments that would 
apply to consultative audit reports under proposed § 1.652(a).  The comments assert that because 
consultative audits are specifically intended to be for internal purposes, FDA should delete 
proposed § 1.652(a) and should not propose any re quirements for consultative audit reports.  
Other comments suggest that we remove the proposed requirement to prepare a consultative 
audit report no later than 45 days after conducting the audit, asserting the deadline is infeasible.  
Still other comments suggested we should allow consultative audit reports to be prepared and 
maintained in languages other than English.   
Some comments interpret proposed § 1.652(a) to require consultative audit reports to be 
submitted to FDA.  Other comments urge us to empha size to industry that proposed § 1.652(a) 
would only require accredited third -party certification bodies to maintain consultative audit 
reports in their records and not submit them to FDA, and that FDA could only access 
consultative audit reports in circum stances meeting the serious adverse health conditions or death 
to humans or animals  (SAHCODHA ) standard for records access under section 414 of the FD&C 
Act.  Other comments note that the proposed rule was silent on the protection of proprietary 
informatio n in audit reports.  
(Response  110)  We disagree with comments suggesting that because consultative audits 
are for internal purposes only, FDA is precluded from imposing any requirements for 
consultative audit reports prepared by accredited third -party cert ification bodies under this rule.  
Section 808(c)(3)(A) of the FD&C Act requires certain elements to be included in reports for all 
food safety audits.  This includes both consultative audits and regulatory audits, which are the 164 
two types of audits describ ed in section 808(c)(4)(B) of the FD&C Act.  Section 808(c)(3)(A) 
sets a 45 -day deadline for the preparation of all audit reports, including consultative audit 
reports, and sets a separate requirement that the audit reports for regulatory audits be submitt ed.  
Section 808(c)(3)(A) of the FD&C Act also gives FDA discretion to designate the form and 
manner of audit reports and to require accredited third -party certification bodies to include in 
audit reports other information that relates to or may influence an assessment of compliance with 
the FD&C Act.  In light of these statutory provisions, we decline the suggestions to delete 
proposed § 1.652(a) or to remove the proposed 45 -day deadline for preparation of a consultative 
audit report.  
We are, however, rem oving the proposed requirement in § 1.652(a) that consultative 
audit reports would need to be prepared and maintained in English in the accredited third -party 
certification body’s records.  As explained in Response 59, we are removing the proposed 
requirem ents for recognized accreditation bodies and accredited third -party certification bodies 
to create and maintain records that do not need to be submitted to FDA, outside of a specific 
request, under this rule in English.   
We disagree with comments suggesti ng that § 1.652(a) should require accredited third -
party certification bodies to submit consultative audit reports to FDA.  We note that section 
808(c)(3)(A) only requires the submission of regulatory audit reports.  Because consultative 
audits are for int ernal purposes, we consider it appropriate to require the maintenance of these 
reports, but not the submission of the reports.  Under section 808(c)(3)(C) of the FD&C Act, we 
could only access consultative audit reports in circumstances meeting the standar d for records 
access under section 414 of the FD&C Act.   165 
With respect to protection of proprietary information in consultative audit reports 
submitted to or obtained by FDA, we note that the final rule includes new provision § 1.695, 
which addresses discl osure and the protection of trade secrets and confidential commercial 
information under applicable law.  
(Comment  111)  Some comments support our proposal to require that consultative audit 
reports under proposed § 1.652(a)(2) and regulatory audit reports under proposed 
§ 1.652(b)(1)(i) and (b)(2) include UFIs for audited facilities and for eligible entities (where 
diffe rent from audited facilities).  In the preamble to the proposed rule (78 FR 45782 at 45812), 
we solicited comment on whether a UFI should comprise a Data Universal Numbering System 
(DUN S®) number and Global Positioning System (GPS) coordinates for an audit ed facility and 
for the eligible entity (if different from the audited facility).   
Some comments support using DUNS® numbers in UFIs for eligible entities and audited 
facilities, asserting that approximately 230 million establishments around the world hav e 
DUNS® numbers.  The comments assert that DUNS ® numbers are easy to obtain and free to the 
establishment.  Comments also emphasize that the use of DUNS® numbers would be 
particularly helpful under the third -party certification rule, because the numbers he lp to 
determine corporate “families ”--e.g., related establishments.   
Other comments oppose using DUNS®  numbers as UFIs, contending that DUNS® 
numbers are not widely used outside the United States and frequently have errors.  Some of these 
comments propose  alternatives to DUNS® numbers, including:  GPS coordinates, FDA’s food 
facility registration numbers, or the U.S. Internal Revenue Service taxpayer identification 
numbers which comments suggest foreign companies can request from U.S. Customs and Border 
Protection.   166 
(Response  111)  We received valuable input in response to our solicitation of comments 
on UFIs for audited facilities and eligible entities.  Having a UFI for eligible entities (and audited 
facilities if different) would be useful to FDA in ide ntifying an eligible entity that does not 
already have a numerical identifier in one of FDA’s databases.  For example, farms generally are 
not required to register with FDA under section 415 of the FD&C Act, so they would not have an 
FDA Food Facility Regi stration Number, unless they conduct activities for which such 
registration is required, and some eligible entities may not have been assigned an FDA Facility 
Establishment Identifier.  
We note that FDA currently is considering whether to require UFIs for regulated 
establishments, such as facilities as defined in 21 CFR 1.227, and the types of numbering 
systems that might be used for UFIs.   Under this final rule, an accredited third -party certification 
body will be required to include a UFI for an audited f acility and for an eligible entity (if 
different from the audited facility) in a consultative audit report under § 1.652(a)(1)(i) and (a)(2), 
and a regulatory audit report under § 1.652(b)(1)(i) and (b)(2), if FDA designates a UFI system.  
(Comment  112) Some comments focus on proposed § 1.652(a)(5), which would require a 
consultative audit report to include any deficiencies observed that require corrective action, the 
corrective action plan, and the date corrective actions were completed.  Some comments ask  us 
to clarify what information about deficiencies should be included in consultative audit reports.  
The comments distinguish between FDA investigators who collect physical evidence during 
inspections and third -party certification bodies who typically obs erve process(es), review 
records, and cite nonconformity to standards --e.g., “Canning retort time did not meet x 
temperature for y time of the scheduled process.”  Other comments ask FDA to clarify that the 
eligible entity, not the audit agent, would be re sponsible for corrective actions, including 167 
analyzing the cause of the nonconformity and developing corrective actions to address the 
nonconformity.  These comments support the proposed requirement to require documentation 
and verification of corrective ac tions, whether through document review or onsite audits.   
(Response  112)  As the comments suggest, third -party certification bodies commonly 
describe their audit findings in terms of conformity or nonconformity with audit criteria, such as 
a GFSI -benchmar ked food safety scheme or the ISO/ TS 22003:2013 series of food safety 
standards  (Ref. 2 4).  Under section 808 of the FD&C Act, accredited third -party certification 
bodies examine eligible entities and their foods for compliance with the applicable food saf ety 
requirements of the FD&C Act and FDA regulations and, for consultative audits, also assess 
conformity with applicable industry standards and practices.   
Under proposed § 1.652(a)(5), a consultative audit report would identify any deficiencies 
observed  by audit agent, which we intended would encompass any deficiency that relates to or 
may influence the accredited third -party certification body’s determination of whether the 
eligible entity is in compliance with the applicable food safety requirements of  the FD&C Act 
and FDA regulations.  We were not proposing to require that consultative audit reports include 
information on an observation solely related to a nonconformity with industry standards or 
practices that FDA does not implement or enforce.  An ob servation relating to both a 
nonconformity with an industry standard or practice and a deficiency that relates to or may 
influence a compliance determination would need to be included in the audit report as a 
deficiency under proposed § 1.652(a)(5).  In re sponse to comments, we are revising 
§ 1.652(a)(5), renumbered as § 1.652(a)(6), to clarify that a consultative audit report must 
include any deficiency that relates to or may influence a determination of compliance with the 168 
applicable food safety requirements of the FD&C Act and FDA regulation s and information on 
the corrective action(s) to address such deficiency.  
We agree with comments distinguishing between the roles of eligible entities (who must 
identify and implement effective corrective actions) and accredited third -party certification 
bodies and their audit agents (who identify deficiencies and verify that effective corrective 
actions have been implemented).  After identifying deficiencies that will require corrective 
action, accredited third -party certification bodies and their audit a gents must maintain their 
impartiality by allowing eligible entities to select the appropriate corrective actions to 
employ.   To recommend or suggest corrective actions to eligible entities during consultative or 
regulatory audits would undermine the objec tivity of the third -party certification bodies or audit 
agents in performing their critical task of verifying the effectiveness of the corrective actions 
once implemented.  To address this concern, we have elected to revis e § 1.651(c)(3)  as described 
in section IX.B., because we believe this issue is better addressed as part of the protocols for 
audits conducted under subpart M.  
(Comment  113)  Some comments assert that proposed § 1.652(b) is unnecessary, because 
many of the elements of regulatory audit repo rts that we propose already are commonly included 
in audit reports.   The comments contend that listing specific elements to be included in a 
regulatory audit report would be too prescriptive and would stifle creativity.  Other comments 
suggest that proposed  § 1.652(b) is overly broad , and the comments object to the elements of the 
audit reports.  Some comments assert that reporting of recent recalls is unnecessary because this 
is information already in FDA’s possession.  Still other comments note that docume nts that are 
routinely part of an audit process may contain critical business information.   These comments 169 
suggest that FDA should consider a “tiered” approach, by requiring only summary reports on 
audit results to be submitted to FDA, not proprietary info rmation.  . 
Other comments support proposed § 1.652(b) and the data elements we proposed to 
require in regulatory audit reports.   Some of these comments seek additional information on the 
form and manner of submitting this information to FDA.  The comments also ask whether the 
regulatory audit reports will be publicly released.  
(Response  113) We disagree with comments suggesting that proposed § 1.652(b) is 
unnecessary because the information we proposed to require in regulatory audit reports already is 
inclu ded in the audit reports prepared by third -party certification bodies.   Although many of the 
elements required to be included in the reports under this rule are currently being included in 
audit reports prepared by thi rd-party certification bodies, i t is important that we require the 
elements included in this final rule because they are essential to the preparation of audit reports 
that are consistent with the purpose of this program.   
We disagree with the comments asserting that proposed § 1.652(b) is ove rly broad and 
the comments contending that the provision is overly prescriptive.  Section 808(c)(3)(A) of the 
FD&C Act requires that audit reports include the dates and scope of the audit and the identity of 
the persons at the audited eligible entity respo nsible for compliance with food safety 
requirements.  Section 808(c)(3)(A) of the FD&C Act also gives FDA discretion to require that 
audit reports include other information that relates to or may influence an assessment of  
compliance with the FD&C Act.   Under proposed § 1.652(b), a regulatory audit report would 
include the elements required by the statute, as well as the following information:  Identifying 
information for the eligible entity (and for the facility, if different from the eligible entity); the  
food(s) and process(es) observed; any deficiencies observed during the audit that relate to an 170 
FDA Class I or Class II recall situation ; and the corrective action plan for such deficiencies.  We 
also proposed to require the regulatory audit report to indi cate whether any sampling and 
laboratory analysis is used in the facility and whether in the 2 years preceding the audit the 
entity:  Issued a food safety -related recall ; made significant changes in the facility, its 
process(es), or products ; or was issued  any food or facility certifications.   
As to the elements of the regulatory audit report in proposed § 1.652, we note that 
paragraphs (b)(1) and (2) provide identifying information for the eligible entity (and the facility 
audited, if different than the e ligible entity) and paragraphs (b)(3) and (5) contain the elements 
required by section 808(c)(3)(A) of the FD&C Act.  We agree with comments asserting that it is 
not be necessary to include information in regulatory audit reports that is already in FDA 
records; therefore, we are removing the proposed requirements in § 1.652(b)(9) and (11) to 
report information on food -safety related recalls conducted by the eligible entity and food and 
facility certifications issued to the eligible entity in the 2 years pre ceding the audit.  We are 
retaining the other elements of the regulatory audit report under proposed § 1.652(b)(4), (6 ) to 
(8), and (10 )--i.e., whether the facility uses sampling and laboratory analysis, whether the entity 
has made significant changes to t he facility, its process(es), or products during the 2 years 
preceding the audit; the foods and process(es) that were observed, as well as any deficiencies 
related to a Class I or Class II recall situation and the corrective action plans for deficiencies --
because they are related to or influential to a determination of compliance with the applicable 
food safety standards of the FD&C Act and FDA regulations.   
As discussed in Response 67, we intend to provide additional instructions relating to the 
form and manner of submitting information to FDA.  We also acknowledge comments’ concerns 
about the protection of proprietary information in regulatory audit reports submitted to FDA.  171 
Information submitted to FDA is subject to public disclosure and under part 20, and we are 
including new § 1.695 on public disclosure in section XIII.F of this final rule.  
(Comment  114)  Some comments contend that the submission of regulatory audit reports 
under proposed § 1.652 would “empower” accredited third -party certification bo dies as “de 
facto” regulatory authorities.  
(Response  114)  We disagree.  Nothing in section 808 of the FD&C Act or in the 
proposed rule would empower accredited third -party certification bodies to implement or enforce 
the FD&C Act or FDA regulations.  Fur ther, section 808(h) of the FD&C Act clearly states that 
audits performed under this section shall not be considered inspections under section 704 of the 
FD&C Act, which governs FDA inspections.  
(Comment  115)  Some comments assert that regulatory audit rep orts should be submitted 
to FDA only when there are questions about product safety.  Some comments suggest that 
proposed § 1.652(b) could be onerous because it would require regulatory audit reports to be 
submitted to FDA in English by no later than 45 day s after the audit was completed.  The 
comments assert that a lack of auditor capacity in countries that export food to the United States 
could make it difficult for accredited third -party certification bodies to meet the 45 -day deadline 
and suggest that FD A should consider adjusting the deadline for regulatory audit report 
submission in light of factors such as auditor capacity and the needs of seasonal producers.  
Other comments support the proposed 45 -day deadline for audit report submission, noting that 
many audit reports currently take more than 45 days to complete, some taking nearly a year to be 
issued. Still other comments focus on the proposed requirement in § 1.652(b) to submit 
regulatory audit reports in English, urging us to accept reports in vari ous languages, including 
Spanish.   172 
(Response  115)  Section 808(c)(3)(A) of the FD&C Act requires as a condition of 
accreditation that regulatory audit reports to be submitted to FDA within 45 days after 
conducting the audit.  Accordingly, we decline the s uggestion to limit the submission of 
regulatory audit reports to circumstances where there are questions about product safety.  We 
also decline to extend the statutory 45 -day deadline for submission of a regulatory audit report.  
We believe that allowing r egulatory audit reports to be submitted in languages other than 
English, as some comments suggest, would create unnecessary obstacles to our program 
management and oversight.  For example, we may review a regulatory audit report to assist us in 
deciding wh ether to accept a certification or to reject the certification after determining that is 
not valid or reliable.  If we were to allow regulatory audit reports to be submitted in languages 
other than English, we might have to wait weeks for a translation.  S uch a delay would postpone 
our decision on whether to accept or refuse the certification and might have negative effects on 
the flow of trade.  
(Comment  116) Some comments oppose a proposal to use DUNS® numbers in UFIs for 
audited facilities and eligible e ntities that would be required to be submitted to FDA in 
regulatory audit reports under proposed § 1.652(b)(1)(i) and (b)(2).  The comments suggest that 
using DUNS ® numbers in UFIs would create a monopoly for Dun and Bradstreet (D&B) and 
give D&B an unfai r competitive advantage.  The comments also express concern that 
establishments will face increased pressure to buy other D&B products.  Other comments 
suggest that DUNS ® numbers are not used outside the United States because, for example, 
DUNS® numbers r equire data such as street names, telephone numbers and other data points that 
small producers located outside the United States might not have.  Instead, these comments 
suggest, FDA should use GPS latitude and longitude coordinates as UFIs.  173 
Some other com ments express support for UFI requirements that would include the use 
of DUNS® numbers in UFIs for audited facilities and eligible entities.  The comments assert that 
because DUNS® numbers are widely used, it would be reasonable for FDA to require DUNS® 
numbers to be used in UFIs under the third -party certification program.   
(Response  116)  As explained in Response 11 1, FDA currently is considering whether to 
require regulated establishments to have UFIs and, if so, whether DUNS® numbers should be 
included  in UFIs.  As explained previously, under this final rule, an accredited third -party 
certification body will be required to include a UFI for an audited facility and for an eligible 
entity (if different from the audited facility) in a regulatory audit repo rt under § 1.652(b)(1)(i) 
and (b)(2), if FDA designates a UFI system.  
(Comment  117)  Some comments agree with proposed § 1.652(b)(4), which would 
require regulatory audit reports to include information on the process(es) and food(s) observed 
during the au dit.  Some comments request clarification of what process(es) and food(s) would 
need to be observed in a facility with several processes, and other comments ask what 
information FDA is seeking about the process(es) that were observed during a regulatory au dit. 
(Response  117)  As explained in Response 106, we do not believe that direct observation 
of each type of food produced under a management system  is necessary when an audit covers the 
appropriate physical locations, activities, and processes that are part of the management system 
to be audited , and information collected during the audit must be relevant to the audit scope, 
purpose, and criteria, in cluding information relating to interfaces between functions, activities, 
and processes of the management system.  Therefore, information on the process(es) and food(s) 
observed by the audit agent (or accredited third -party certification body that is an in dividual) is 
useful in light of the scope of the audit and the management system(s) audited.  174 
(Comment  118)  Some comments endorse proposed § 1.652(b)(8), which would require 
the regulatory audit report to include information on whether sampling and analysi s is used at the 
facility being audited.  Of the comments that support proposed § 1.652(b)(8), some would further 
require regulatory audit reports to include reporting of sampling and analytical results of 
sampling by the eligible entity.  Others suggest i ncluding analytical results relating to any 
deficiencies observed during an audit and the effectiveness of corrective actions taken to address 
the deficiency.  
(Response  118)  We agree that it is useful for FDA to have information on whether an 
eligible ent ity uses sampling and analysis as a tool for verifying the effectiveness of its controls. 
Section  1.652 does not require sampling or analysis on a routine basis; however, analytical  
reports m ust be included in regulatory audit reports if the certification body finds them to be 
relevant to the any elements of an audit report, such as a verification of corrective actions or in 
support of a decision not to certify.  We note that sampling or analytical reports that are collected 
as part of a regulatory audit mu st be maintained as required under § 1.658 (a)(3).   
(Comment  119)  Some comments support proposed § 1.652(b)(9), which would require 
information on recent recalls to be included in regulatory audit reports.  Other comments suggest 
that requiring recall inf ormation to be included in a regulatory audit report might lead to 
questions about the validity of a certification that the accredited third -party certification body 
might issue based on the results of its regulatory audit of the eligible entity.  Some oth er 
comments suggest that requiring an accredited third -party certification body to include 
information on recent recalls in a regulatory audit report would be duplicative, because FDA 
should already have information on any recalls of regulated product expo rted to the United 175 
States, and recalls of product that was not exported to the United States would not be relevant to 
the regulatory audit report.   
(Response  119)  We agree with comments suggesting that it would be duplicative to 
require accredited third -party certification bodies to include information on recent recalls in 
regulatory audit reports and are removing proposed § 1 .652(b)(9) in the final rule.   
(Comment  120)  Some comments ask for clarification on proposed § 1.652(b)(11), which 
would require information on recent certifications to be included in regulatory audit reports.  The 
comments ask whether a certification issued outside of the third -party certification program 
should be included in a regulatory audit report and if so, should the report identify the standards 
under which the certification was issued.  
(Response  120)  Requiring information on certifications issued under the third -party 
certification program would be duplicative because certifications previously issued by the 
accredited thir d-party certification body under the program already would have been submitted 
to FDA.  Further, we see no benefit to requiring the submission of information on certifications 
issued outside of this program.  Accordingly, we are removing proposed § 1.65 2(b)(11) from the 
final rule.   
(Comment 121)  Some comments urge us to create a clear mechanism for eligible entities 
to appeal adverse audit results.   
(Response  121)  Under proposed § 1.652(d) an accredited third -party certification body 
would have to impl ement written procedures for receiving, evaluating, and deciding on eligible 
entity challenges to adverse regulatory audit results.  We believe this section provides a clear 
mechanism for eligible entities to be able to appeal adverse regulatory audit resu lts.  As 176 
explained in Response 36, we are clarifying that persons presiding over such appeals may be 
internal or external to the accredited third -party certification body.  
D.  What Must  an Accredited Third -Party Certification Body Do When Issuing Food or Facility 
Certifications ? (§ 1.653)  
The proposed rule describes the activities that an accredited third -party certification body 
would have to perform when issuing food and facility certifications.  Proposed § 1.653 would 
require the certification body to have conducted a regulatory audit un der proposed § 1.651 and to 
conduct any other activities necessary to determine compliance under the applicable food safety 
requirements of the FD&C Act and FDA regulations.   
No certificate could be issued until the eligible entity took corrective actions  to address 
any deficiencies reported  under proposed §  1.652(b)(6), and the corrective actions were verified 
by the accredited third -party certification body.  The verification would need to occur onsite, 
unless the deficiency was a minor issue.  A single audit could result in food and facility 
certifications or multiple food certifications only if the regulatory audit requirements were met as 
to each.  
Where a certification body uses audit agents, the certification body, not the audit agent, 
would make the determination whether to issue certification.  However, the statute allows for 
individuals to be accredited as certification bodies; in that circumstance, the same individual 
would conduct the audit and also determine whether to issue certification.  
On our  own initiative, we are revising § 1.653(a)(3) to replace the phrase “assessment 
made during” with “the data and other information” to clarify what an accredited third -party 
certification body must consider when determining whether an eligible entity is in  compliance 
with the applicable food safety requirements of the FD&C Act and FDA regulations.    177 
On our own initiative, we are making a number of revisions § 1.653(b) .  We are revising 
paragraph (b)(1) to clarify that the accredited third -party certificatio n body may issue a food or 
facility certification under this subpart for a term of up to 12 months.  Throughout paragraph 
(b)(2) we are specifying that the food or facility certification must contain information about 
regulatory audits.  At our own initiat ive, we are revising § 1.653(b)(2)( ii) and (iii) to require 
accredited third -party certification bodies to provide the FEI of the audited facility and the FEI of 
the eligible entity, if different from the audited facility, and we revised § 1.653(b)(2) ( iv) to 
require accredited third -party certification bodies to assign numbers to certifications they issue 
under the program.  We are revising paragraph (b)(3) to clarify that FDA may refuse to accept 
any certification for purposes of section 801(q) or 806 of the FD&C Act if we determine that the 
certification is not valid or reliable.  We are also adding new subparagraph (b)(3)(iii) to specify 
that if the certification was issued without reliable demonstration that the requirements of 
paragraph (a) were met, w e may determine that the certification is not valid or reliable.  
(Comment  122)  Some comments contend that proposed § 1.653(a)(2) would require 
accredited third -party certification bodies to perform onsite verifications of corrective actions in 
situations  where other methods of verification would be adequate.  The comments assert that, by 
requiring onsite verification for any corrective action (other than an action taken to address 
recordkeeping deficiencies), the proposed rule would impose undue costs on eligible entities and 
would exacerbate issues of auditor capacity.  
The comments suggest that we allow for remote verification of corrective actions through 
photographs, live web -cam transmissions, and any other means that would provide evidence that 
corre ctive action has been taken and the eligible entity is in compliance with the FD&C Act.  
The comments suggest that FDA may, in its discretion, require onsite visits to confirm that 178 
corrective actions were taken in extraordinary situations where efforts sho rt of onsite observation 
would be insufficient to protect the public, such as in Class I recall situations.  Some comments 
urge us to follow the requirement s of ISO/IEC 17021:2011 (Ref. 6) for verification of corrective 
actions.   
(Response  122)  We agree that onsite verification of corrective actions would not be 
necessary to address every deficiency identified in a regulatory audit report under proposed 
§ 1.652(b)( 6).  ISO/IEC 17021:2011 (Ref. 6) (clauses 9.1.12 -9.1.13) describes a range of 
activities --from document review to onsite verification to additional full audits --that a third -party 
certification body may use verifying the effectiveness of corrective actions.  Remote verification 
may be appropriate where it would provide an adequate basis for the a ccredited third -party 
certification body to determine that the eligible entity had implemented effective corrective 
action(s) to address the identified deficiency or deficiencies.  Accordingly, we are revising 
§ 1.653(a)(2) to expand the methods of verific ation an accredited third -party certification body 
may use to verify corrective actions for deficiencies identified in § 1.652(b)(6),  except that 
corrective actions in a facility that was the subject of a notification under § 1.656(c) must be 
verified onsi te. 
(Comment  123)  Some comments urge FDA to establish qualifications for the individuals 
accredited third -party certification bodies would use to make certification decisions.  The 
comments suggest that an accredited third -party certification body should use a panel of experts 
with appropriate industry or regulatory experience to make certification decisions on behalf of 
the body.  Other comments urge FDA to identify the criteria an accredited third -party 
certification body should use in determining whethe r to issue certification under section 808 of 
the FD&C Act.  179 
(Response  123)  We agree with the comments suggesting that individuals involved in 
compliance determinations and certification decisions under section 808 of the FD&C Act must 
be appropriately qua lified for those responsibilities.  We agree that decisions on certification 
should be made by individuals other than audit agents who conducted the regulatory audits that 
would form the basis for the decisions on certification, except individuals accredit ed as third -
party certification bodies may perform regulatory audits and issue certifications based on the 
results of regulatory audits they performed.  An assessment for accreditation of a third -party 
certification body under § 1.642 would focus not only on its competency and capacity for 
auditing food facilities but also on its capacity to review audit results to determine compliance 
with applicable food safety requirements for purposes of certification.  While an accredited third -
party  certification body  may wish to use a panel of experts for certification decisions, it is not 
necessary under this rule.  
(Comment  124)  Some comments suggest that certifications issued under section 808 of 
the FD&C Act should clearly delineate the scope of products and proce sses covered by the 
certification.  
(Response  124)  Proposed § 1.653(b)(2)(iv) and (vi) would require the certification to 
include both the scope of the audit and the scope of the food or facility certification.  We believe 
the concern about the scope of pr oducts and processes covered by the food or facility 
certification is adequately addressed by the proposed rule, and we are retaining these provisions 
in the final rule.  180 
E.  When Must  an Accredited Third -Party Certification Body Monitor an Eligible Entity  That It 
Has Issued a Food  or Facility Certification ? (§ 1.654)  
Proposed § 1.654 would require an accredited third -party certification body to conduct 
monitoring of an eligible entity if the certification body has reason to believe that an eligible 
entity to which it issued a certification may no longer be in compliance with the FD&C Act.  
(Comment  125)  Comments endorsing proposed § 1.654 suggest that FDA establish 
criteria for the “reason to believe” standard --that is, the circumstances FDA believes would 
trigger a requirement for an accredited third -party certification body to monitor an eligible entity.  
The comment further suggests that FDA should make these criteria available for public 
comment.  
(Response  125)  FDA declines to codify specific criteria t hat would trigger the need for 
an accredited third -party certification body to conduct monitoring of an eligible entity to 
determine whether the entity is still in compliance with applicable requirements, as such criteria 
would be fact -specific and FDA can not contemplate all situations that would require such 
monitoring.  FDA envisions that the circumstances that might trigger monitoring under § 1.654 
are ones that may affect the eligible entity’s capability to continue to comply with the applicable 
food sa fety requirements of the FD&C Act and FDA regulations, such as:  (1) S ignificant 
changes to the audited facility, such as capital improvements; (2) major changes to the eligible 
entity’s management system and processes; or (3) changes to the scope of opera tions, such as 
changes in manufacturing processes, that may affect the compliance status of an eligible entity.  
(Comment  126)  Other comments urge FDA to require an accredited third -party 
certification body to notify an eligible entity immediately upon det ermining that monitoring of 
the eligible entity prior to recertification would be necessary.  181 
(Response  126)  We decline the suggestion to require notification of an eligible entity 
prior to monitoring under § 1.654, as we believe it is more appropriate for  the accredited third -
party certification body to decide based on the circumstances whether it should alert an eligible 
entity it has certified that monitoring is necessary or conduct unannounced monitoring activities.  
An accredited third -party certificat ion body may choose to notify an eligible entity before 
conducting monitoring activities that are unrelated to the eligible entity’s annual audit for 
recertification purposes, which must be conducted on an unannounced basis pursuant to 
§ 1.651(c)(1).  
F.  How Must  an Accredited Third -Party Certification Body Monitor its Own Performance ? 
(§ 1.655)  
Proposed § 1.655 would require an accredited third -party certification body to conduct 
self-assessments annually and in the case of revocation of the recognition o f its accreditation 
body and prepare a report of the results of each self -assessment.  
On our own initiative, we are revising § 1.655(a)(1) to clarify that as part of the self -
assessment, an accredited third -party certification body must evaluate the perfo rmance of its 
audit agents in examining facilities, process(es), and food using the applicable food safety 
requirements of the FD&C Act and FDA regulations , which will conform with other changes 
being made to the final rule.  
(Comment  127)  Some comments support the proposal to require accredited third -party 
certification bodies to conduct self -assessments.  Other comments recommend that FDA should 
be more explicit in the requirements for self -assessments.  
(Response  127)  We decline the suggestion to be more explicit in the requirements for 
self-assessments, as the requirements in § 1.655 include sufficient details for conducting self -182 
assessments.  Comments did not provide adequate justification for adding additional ele ments to 
the self -assessment.   
(Comment  128)  Some comments request that accredited governmental certification 
bodies be allowed to conduct self -assessments at a frequency different than other accredited 
third -party certification bodies.   
(Response  128)  We decline to create different timeframes for self -assessments for 
governmental versus private certifications bodies.  As explained in Response 39, § 1.655 is part 
of a set of proposed monitoring and self -assessment requirements intended to work together in 
helping to ensure that the recognized accreditation bodies and accredited third -party certification 
bodies maintain compliance with the rule’s requirements.  The certification body self -assessment 
in § 1.655 is intended to serve, in part, as information  for use in the annual accreditation body 
monitoring in § 1.621, the results of which we intend the accreditation body to use in its annual 
self-assessment under § 1.622.  This system of assessments takes place on an annual basis and is 
an essential part o f the program’s safety net.  Allowing different timeframes for assessments by 
different participants would undermine the credibility of the program and create undue 
administrative complexity.  We believe this section will be far less burdensome in practice  than 
some of the commenters may have anticipated.  We note that to address general concerns about 
the burden of these requirements, similar to other sections of the final rule, FDA is adding a new 
§ 1.655(e) to allow an accredited third -party certificatio n body to use documentation of its 
conformance to ISO/IEC 17021:2011 or ISO/IEC 17065:2012, supplemented as necessary, to 
meet the requirements of this section.  183 
(Comment  129)  Some comments assert that accredited third -party certification bodies 
should not  be required to be prepare self -assessment reports in English under proposed 
§ 1.655(d).   
(Response  129)  In response to comments and consistent with revisions made elsewhere 
in the final rule, we are removing the English language requirement in § 1.655(d ) for self -
assessment reports prepared by third -party certification bodies accredited by a recognized 
accreditation body.  However, we are now including a requirement in §  1.656(b) of submission 
in English for self -assessment reports prepared by third -party certification bodies directly 
accredited by FDA and self -assessments submitted to FDA as a result of an FDA request for 
cause or due to the termination of an accreditation body’s recognition due to denial of renewal, 
revocation, or relinquishment/failure  to renew under §  1.631(f)(1)(i), 1.634(d)(1)(i), or 
1.635(c)(1)(i), respectively.  
G.  What Reports  and Notifications Must an Accredited Third -Party Certification Body Submit ? 
(§ 1.656)  
Proposed § 1.656 would establish requirements for various reports and  notifications that 
accredited third -party certification bodies would have to submit to FDA and, as appropriate, 
recognized accreditation bodies.  Proposed § 1.656(a) would establish the requirements for 
submission of regulatory audit reports, and proposed  § 1.656(b) would establish the requirements 
for submission of reports of accredited third -party certification body self -assessments.   
Proposed § 1.656(c) would require an accredited third -party certification body to 
immediately notify us, in English, of a condition that could cause or contribute to a serious risk 
to the public health (notifiable condition) that the certification body (or its audit agent) 
discovered while conducting a regulatory or consultative audit of an eligible entity.  In the 184 
preamble  discussion of proposed § 1.656(c) (78 FR 45782 at 45815), we solicited examples of 
conditions that might and might not meet the standard in section 808(c)(4)(A) of the FD&C Act 
for notifying FDA.  We asked for input on whether the FDA Class I and Class II  recall standards, 
taken together, might adequately address any condition covered by section 808(c)(4)(A) of the 
FD&C Act.  
Proposed § 1.656(d) would require an accredited third -party certification body to 
immediately notify us electronically, in English, u pon withdrawing or suspending the food or 
facility certification of an eligible entity.  Proposed § 1.656(e)(1) would require an accredited 
third -party certification body that notified FDA under proposed § 1.656(c) also to notify the 
eligible entity where the condition was discovered.  Proposed § 1.656(e)(2) would require the 
accredited third -party certification body to notify its accreditation body (or, in the case of direct 
accreditation, to us) electronically, in English, within 30 days after making any significant 
change that may affect its compliance with the requirements of §§  1.640 through 1.658.  
On our own initiative we are revising § 1.656(c)(1) and (2) to clarify  if a condition that 
could cause or contribute to a serious public risk to the public h ealth is discovered,  that in 
addition to the name of the eligible entity  and/or facility, an accredited third -party certification 
body must also provide the physical address, unique facility identifier  (if designated by FDA) , 
and the registration number un der subpart H of this part (where applicable).   
(Comment  130)  Some comments support proposed § 1.656(a), which would require 
submission of regulatory audit reports to FDA, but would not require reports of consultative 
audits to be submitted.  Other comments interpret the proposed rule as requiring submission of 
consultative audit reports to FDA and the reporting of laboratory analytical results under section 
422 of the FD&C Act.   185 
(Response  130)  Under section 808(c)(3)(A) of the FD&C Act, an accredited third -party 
certification body or an audit agent of a third -party certification body, where applicable , “shall 
prepare, and, in the case of a regulatory audit, submit, the audit report for each audit 
conducted…”  Based on the statutory language, it is clear that Congress only desired reports of 
regulatory audits to b e submitted to FDA.  We also note that section 808(c)(3)(C) of the FD&C 
Act limits the ability for FDA to access the results of consultative audits to circumstances 
described in the records access standard of section 414 of the FD&C Act.  Some comments 
incorrectly interpreted the proposed rule to require the submission of the certification bodies’ 
laboratory records and results. We are only requiring maintenance of such records and results 
under § 1.658.   
(Comment  131)  Some comments contend that we are in terpreting the notification 
standard in section 808(c)(4)(A) of the FD&C Act too broadly, because the statute only requires 
accredited third -party certification bodies to notify FDA of notifiable conditions discovered 
during a regulatory audit.  The commen ts assert that Congress did not intend us to require 
notification of conditions found during consultative audits, because those audits are for internal 
purposes; therefore, we should revise proposed § 1.656(c) to remove the reference to a 
consultative audi t.  Other comments assert that notifications submitted for conditions found 
during a consultative audit could overwhelm FDA with data that could make it difficult to 
identify the most serious risks to public health.  Still other comments support our propos al to 
require notification of conditions found during consultative and regulatory audits.  
Some comments describe a range of activities that generally may be referred to as 
consultative audits and suggest that requiring notification to FDA of conditions fou nd during 
these types of consultative audits may have unintended consequences.  The comments note the 186 
important role of third -party audits (and consultative audits, in particular) in assisting the food 
industry identify and fix internal problems and drive continuous improvements.  The comments 
suggest that requiring notification during consultative audits might create disincentives for firms 
who might otherwise use accredited third -party certification bodies to perform consultative 
audits and for third -party certification bodies who might otherwise be interested in participating 
in the program.  
(Response  131)  We decline the suggestion to limit § 1.656(c) to require notification only 
of conditions found during a regulatory audit, because s ection 808(c)(4)(A)  and (B) of the FD&C 
Act require notification based on conditions found “at any time during an audit” and identifies 
“audits” as both consultative and regulatory audits.   
Although we decline to limit § 1.656(c) as the comment suggest s we believe that many  of 
the concerns about notification during a consultative audit are mitigated by revisions that clarify 
the scope of the consultative audits that are, and are not, covered by the rule  (see Sections III.E  
and III.J).  Under the final rule, an accredited t hird-party certification body would only be 
required to notify FDA of a condition that could cause or contribute to a serious risk to the public 
health if the condition was discovered during an audit that an eligible entity has specifically 
declared to be a regulatory audit for certification purposes or a consultative audit in preparation 
for a regulatory audit under this rule.  
(Comment  132)  Several comments contend that “serious risk to the public health” has 
the same meaning as “serious adverse health cond itions or death to humans or animals” 
(SAHCODHA) as that phrase is used throughout the FD&C Act.  Specifically, the comments 
assert that FDA should only require accredited third -party certification bodies to notify FDA of 187 
conditions that pose a risk of SAH CODHA, as that standard is interpreted for purposes of the 
Reportable Food Registry (RFR) under section 417 of the FD&C Act  (21 U.S.C. 350f) .  
The comments reject our tentative conclusion that the range of conditions that require 
notification under section  808(c)(4)(A) of the FD&C Act is broader than SAHCODHA, because 
the statute describes notifiable conditions as ones that “could” cause or contribute to a serious 
risk to public health.  In response to our request for input, the comments specifically reject  an 
interpretation of “serious risk to the public health” that might include, for example, conditions 
that pose a risk of temporary or medically reversible adverse health consequences or where the 
probability of adverse health consequences is remote.  Some comments suggest that accredited 
third -party certification bodies and audit agents would be more readily able to identify conditions 
that pose a SAHCODHA risk but would find it more difficult to identify other conditions that 
would need to be notified  to FDA under proposed § 1.656(c).  Other comments support our 
tentative conclusion that a “condition that could cause or contribute to a serious risk to the public 
health” is broader than a condition relating to a SAHCODHA risk.  
(Response  132)  We disagr ee with comments suggesting that the phrase “serious risk to 
public health” in section 808(c)(4)(A) of the FD&C Act should be interpreted as a risk of 
SAHCODHA.  We note that Congress chose to incorporate SAHCODHA in section 
808(c)(6)(A) to describe outbre ak situations that would lead to withdrawal of accreditation, but 
did not use SAHCODHA in describing the conditions that must be notified to FDA under section 
808(c)(4)(A) of the FD&C Act.  Additionally, Congress chose to incorporate SAHCODHA in 
other sect ions of FSMA, such as in provisions on suspension of registration in section  102(b) 
amending section 415 of the FD&C Act.  In light of the foregoing, we believe that Congress 
intended for a “serious risk to the public health” to be distinct from a risk of SAHCODHA and, 188 
therefore, reject the suggestion that accredited third -party certification bodies would only need to 
notify FDA of conditions that pose a risk of SAHCODHA under proposed § 1.656(c).  We 
conclude that notifiable conditions include not only tho se that present a risk of SAHCODHA, but 
also other conditions that “could cause or contribute to a serious risk to the public health.”   
Although it is difficult to predict the range of conditions or circumstances that accredited 
third -party certification bodies and audit agents might encounter, we offer some factors that may 
be useful in identifying whether a condition would need to be notified under § 1.656(c), such as 
whether the condition relates to incoming ingredients that will be subject to control w ithin the 
facility, or an area of the facility where pre -production materials are held; whether the condition 
relates to the post -processing environment or where finished product is held prior to distribution; 
and whether the condition relates to food, pro cess(es), or areas of the facility associated with 
food that is destined for export to the United States, and not if it relates solely to food, 
process(es), or areas of the facility associated with food for consumption other than in the United 
States.   
(Comment  133)  Some comments urge us to revise proposed § 1.656(c) to incorporate the 
limitations on reporting that apply to the RFR under section 417(d)(2) of the FD&C Act, such 
that notification would only be submitted if food adulterated as a result of th e notifiable 
condition had left the control of the eligible entity.  The comments assert it would be reasonable 
for FDA to interpret section 808(c)(4)(A) of the FD&C Act such that an accredited third -party 
certification body would not need to alert FDA imm ediately upon discovering a notifiable 
condition if the eligible entity reworked adulterated product or destroyed it before the adulterated 
food was transferred to another person.  Other comments suggest that proposed  § 1.656(c) is 
redundant because such c onditions are subject to RFR reporting.  189 
(Response  133)  We decline the suggestion to revise § 1.656(c) to incorporate an 
exception similar to section 417(d) of the FD&C Act as there is no exception to the notification 
requirement in section 808(c)(4) as th ere is in section 417(d).  Further, we believe the 
notification requirement in section 808(c)(4) serves not only to inform FDA of potential risks to 
the public, but also enhances credibility of the program by giving FDA, accredited certification 
bodies, an d recognized accreditation bodies information that may be relevant to our oversight of 
the food safety and third -party  programs.   We believe that given the statutory language and goals 
of the third -party  certification program, it is appropriate for the not ification requirement in this 
rule to have different requirements and exceptions than other notification provisions in the 
FD&C Act.   
As such, we also disagree with comments suggesting the obligation of a responsible party 
to submit a report to FDA throug h the RFR makes proposed § 1.656(c) redundant.  Among other 
things, RFR requirements only apply to facilities that are required to register with FDA under 
section 415 of the FD&C Act.  An eligible entity that is a farm, for example, would not be 
subject to  RFR requirements.  Additi onally, as discussed previously,  the reporting requirement 
under this rule  contains no exception for circumstances when the food adulterated as a result of 
the notifiable condition has not left the control of the eligible entity.   In light of the foregoing, we 
are retaining § 1.656(c) without  the revision s suggested by the comments . 
(Comment  134)  Some comments urge us to revise proposed § 1.656(e)(1) to allow for 
concurrent notification of FDA and the eligible entity where the not ifiable condition was 
discovered.  
(Response  134)  We agree and are adding to §  1.656(e)(1) a provision that allows, where 
feasible and reliable, for the accredited third -party certification body to contemporaneously 190 
notify its recognized accreditation body and/or the eligible entity when notifying FDA.  We note 
that this provision does not affect the obligation for the accredited third -party certification body 
to notify FDA immediately of a notifiable condition under  § 1.656(c).   
H.  How Must  an Accredited Third -Party Certification Body Protect Against Co nflict s of 
Interest ? (§ 1.657)  
Proposed § 1.657 sets out the elements of a conflict of interest program that an accredited 
third -party certification body would be required to have.  Proposed § 1.657(a) would require the 
accredited third -party certification body to have a written program  that covers the certification 
body itself and any of its officers, employees, or other agents (e.g., audit agents) conducting 
audits or certification activities under this program.  Proposed § 1.657(b) would address the 
requirement, in section 808(c)(5)(C ) of the FD&C Act, to issue implementing regulations that 
include a structure to decrease the potential for conflicts of interest, including timing and public 
disclosure, for fees paid by eligible entities to accredited third -party certification bodies.  
Proposed § 1.657(c) would impute to an accredited third -party certification body’s officer, 
employee, or other agent the financial interests of his or her spouse and minor children, if any.  
Proposed § 1.657(d) would require an accredited third -party certif ication body to maintain on its 
Web site an up -to-date list of eligible entities to which it  issued certifications under this subpart, 
the duration and scope of each such certifications, and the date on which the eligible entity paid 
any fee or reimbursem ent under proposed § 1.657(c).   
On our own initiative, we are revising the accredited third -party  certification body 
conflict of interest provisions in § 1.657(a) (1) to clarify that the certification body , its officers, 
employees, and other agents involve d in auditing and certification activities cannot own, operate, 
have a financial interest in, manage, or otherwise control an eligible entity to be certified.  We 191 
also are  redesignating proposed paragraphs (a)(2 ) to (4) as (a)(3 ) to (5) and adding a new 
paragraph (a) (2) to conform to section 808(c)(5)(A)(i) of the FD&C Act.  Additionally, we are 
revising redesignated § 1.657(a)(3) to add financial interests, management, or control to the 
proposed list of prohibited interests for audit agents.  
(Comment  135)  Some comments support proposed § 1.657, asserting that it strikes the 
right balance between ensuring rigorous protections against conflicts of interest and protection of  
trade secrets and confidential commercial information.  Other comments oppose the t hird-party 
certification program that is the subject of this rulemaking because private auditors are inherently 
conflicted and food safety inspections should be conducted only by FDA.   
Other comments suggest various additional conflict of interest restric tions that should be 
placed, such as requiring an individual audit agent or an individual accredited as a third -party 
certification body to divest of all interests in FDA -regulated food firms; prohibiting such 
individual from conducting a regulatory audit of an eligible entity where the individual 
previously conducted a consultative audit or where the individual was previously employed; and 
prohibiting the individual from accepting an offer of employment from an audited eligible entity 
for 1 year following an audit.  Still other comments urge FDA to prohibit meals or beverages 
from being provided during an audit or to define the de minimis value of meals and beverages 
that may be provided onsite during an audit.   
(Response  135)  We believe the accredited th ird-party certification program that 
Congress directed us to establish under section 808 of the FD&C Act will provide a valuable 
complement to FDA inspections and will allow us to leverage rigorous, independent third -party 
audits in helping to ensure the s afety of the U.S. food supply.  We disagree with comments 192 
contending that third -party certification programs are so inherently conflicted that such a 
program is not worthwhile.  
We believe the conflict of interest restrictions for accredited third -party cer tification 
bodies and for their audit agents that are established by section 808 of the FD&C Act for public 
and private third -party  certification bodies , as implemented by this rule, provide the safeguards 
necessary for a credible third -party certification  program.  Accordingly, we decline suggestions 
to revise § 1.657 to place additional conflict of interest limitations that would be impractical and 
unnecessary, such as  requiring :  (1)  Requiring full divestment by audit agents of interests in any 
FDA -regul ated food firm; (2) prohibiting an individual who conducted a consultative audit of an 
eligible entity from ever conducting a regulatory audit of the same eligible entity; (3) prohibiting 
an individual who audited an eligible entity from accepting an offer  of employment from the 
eligible entity for 1 year following the audit; and (4) prohibiting an individual conducting an 
audit from accepting a beverage or a meal of de minimis value that is provided onsite during 
audit.   
We disagree with comments suggesti ng that by providing meals of a de minimis value, an 
eligible entity or facility might influence the outcome of an audit by an accredited third -party 
certification body, particularly if the only allowable meals are ones of minimal value that are 
provided d uring the course of an activity and with the purpose of facilitating timeliness and 
efficiency.  As explained in Response 55, FDA follows a similar approach for investigators 
conducting foreign inspections --that is, FDA investigators performing foreign ins pections are 
allowed to accept lunches  (of little cost) provided by firms during the course of foreign 
inspections.  We also note that the U.S. government allows its employees to accept meals, within 
per diem limits, when on official business in a foreign country, as an exception to the prohibition 193 
on the acceptance of gifts or gratuities from outside sources (5 CFR 2635.204(i)(1)), though we 
believe the FDA’s practices for foreign inspections serve as a better model because foreign 
inspections are more ana logous to foreign audits than are the range of activities that covered by 
the general requirements applicable to all U.S. government employees on official business in 
foreign countries.  Accordingly, in light of the comments received and analogous FDA 
guidelines, we have concluded that it is reasonable and appropriate to limit the meal exception in 
§ 1.657(a)(4)(ii) to only lunches of de minimis value provided during the course of an audit, on 
site at the premises where the assessment is being conducted, an d only if necessary to facilitate 
the efficient conduct of the audit.  We believe these revisions help to address concerns regarding 
the threats to impartiality, while accommodating the practical considerations that apply to 
foreign audits.   
Consistent wi th our guidance to recognized accreditation bodies under Response 55, we 
offer the following additional input to accredit ed third -party  bodies seeking guidance on the 
application of § 1.657(a)(4)(ii).  In considering whether a meal is allowable under this provision, 
we recommend first considering whether accepting the lunch is necessary to facilitate the 
efficient conduct of the audit.  We recommend considering : (1) Whether the circumstances 
surrounding the travel would allow a lunch to be packed  bring on s ite; (2)  Whether the meal is 
being provided during the midday or early afternoon.  A lunch provided in the midst of an audit 
is different than a lunch or other meal provided at  the completion of the audit; (3)  Whether the 
site of the audit is in close prox imity to a retail food establishment, or is at a remote location far 
from a retail food establishment;  (4) What is the estimated value (or cost) of the lunch in light of 
the costs associated with the area where the audit is being conducted; and (5) other s imilar 
considerations.   194 
For accredited third -party certification bodies or audit agents seeking additional guidance 
on determining what constitutes a “de minimis” amount for purposes of complying with 
§ 1.624(a)(3)(ii), we offer the following guidance tha t is based on the requirements applicable to 
U.S. government employees who accept certain meals while on official travel in foreign 
countries.  Such employees must deduct from the per diem the value of that meal , calculated 
using a two -step process.  
First,  the individual must determine the per diem applicable to the foreign area where the 
meal  was provided, as specified in the U.S. Department of State ’s Maximum Per Diem 
Allowances for Foreign Areas, Per Diem Supplement Section 925 to the Standardized 
Regula tions (GC,FA) available from the Superintendent of Documents, U.S. Government 
Printing Office, Washington, DC 20402, and availa ble on the Department of State W eb site at 
https://aoprals.state.gov/Web920/per_diem.asp .  (Foreign per diem rates are establishe d monthly 
by the Department of State’s Office of Allowances as maximum U.S. dollar rates for 
reimbursement of U.S. Government civilians traveling on official business in foreign areas.)  
Second, the individual must determine the appropriate allocation for the meal  within the 
daily per diem rate which is broken down into Lodging and M&IE  that are reported separately in 
Appendix B  of the Federal Travel Regulation and available on the Department of State’s website 
at https://aoprals.state.gov/content.asp?conte nt_id=114&menu_id=78 .  
Accordingly,  under § 1.657(a)(4)(ii),  an accredited third -party certification body that is 
an individual or an audit agent of an accredited third -party certification body who is conducting a 
food safety audit of an eligible entity may accept lunch provided during an audit and on the 
premises where the audit is conducted, if necessary to facilitate the efficient conduct of the audit.  195 
(Comment  136)  Some comments raise concerns about possible conflicts of interests.  
Some comments urge us to attach additional controls to the accreditation of for eign cooperatives 
to prevent them from auditing and certifying their members’ facilities and food.  Other 
comments recommend we further consider the difficulties involved with foreign governments 
demonstrating impartiality of their processes in auditing an d certifying facilities owned by the 
foreign government.   
(Response  136)  We note that u nder proposed §  1.657, foreign cooperatives accredited as 
third -party certification bodies  would not be able to  audit or certify their members’ facilities or 
foods un der the program, because of their shared financial interests.  
We decline the suggestion to develop special sets of controls for one or more types of 
third -party certification bodies eligible to be considered for accreditation under section 808 of 
the FD&C  Act.  We note that the conflict of interest requirements in section 808(c)(5) of the 
FD&C Act apply equally to the foreign governments, agencies of foreign governments, foreign 
cooperatives, and other third -parties.  That is, a foreign government accredit ation body that is 
recognized by FDA under this program may accredit government auditors (i.e., the competent 
authority for food safety) from the same nation, provided that the conflict of interest 
requirements in § 1.657 are met.  Consistent with the appr oach taken in the statute, we believe 
that this comprehensive, rigorous set of conflict of interest requirements make it unnecessary for 
us to create a different or special controls for certain types of certification bodies.   
(Comment  137)  Some comments support the proposal to require accredited third -party 
certification bodies to maintain up -to-date lists of eligible entities to which food or facility 
certification were issued, together with the duration and scope of each such certification.  The 
comment s suggest that having this information readily available would be helpful to importers 196 
seeking to participate in VQIP and those seeking to import food that is subject to import 
certification under section 801(q) of the FD&C Act.   
Other comments suggest th at requiring an accredited third -party certification body to 
maintain a list of certified eligible entities on its Web site, together with the dates each eligible 
entity paid certification fees, could create an unfair competition.  The comments contend tha t the 
statute does not require disclosure of the date of payment of fees and seek clarification on the 
basis for disclosing the timing of fee payments.  Other comments suggest that information on 
payment of fees should remain confidential between the accre dited third -party certification body 
and the eligible entities it audited and suggest the information could be made available to FDA 
on request.  Still other comments contend that FDA should only have access to information on 
fee payments by eligible entit ies upon a showing of cause.   
(Response  137)  We agree with comments suggesting that Web site listings of eligible 
entities to which food or facility certification were issued will be helpful to importers .  We 
disagree that such information would create u nfair competition, and the comment did not provide 
an explanation as to why this would be the case.  To the contrary, publicizing this information 
will increase transparency and accountability of the program.   We are not proposing to require 
disclosure of the amount of fees paid by eligible entities, because we are concerned that 
publicizing the amounts of fee payments may lead to certification bodies using this information 
to gain a competitive advantage by off ering audits at discount rates.  However, we believe 
proposed § 1.657(c) meets the requirement of section 808(c)(5)(C)(ii) of the FD&C Act to 
provide information on the timing of fee payments and will help build confidence in the third -
party certification program by providing assurances that payments are not related to the results of 
regulatory audits.  We decline to adopt the alternative approach suggested by comments --i.e., 197 
such information should be disclosed to FDA only when needed to investigate proble ms if they 
occur, and publicly released only if disclosure would improve public health --as inadequate to 
satisfy the requirements of section 808(c)(5)(C)(ii) of the FD&C Act.  In light of the foregoing, 
we are retaining § 1.657(c), redesignated as § 1.657( d), as proposed.  
I.  What Records Requirements Must a Third -Party Certification Body That Has Been 
Accredited Mee t? (§ 1.658)  
Proposed § 1.658 would require accredited third -party certification bodies to maintain the 
following documents and data electronic ally, in English, for 4 years, to document compliance 
with the rule:  (1) Requests for regulatory audits; (2) audit reports and other documents resulting 
from a consultative or regulatory audit; (3) any notification of a condition under proposed 
§ 1.650(a)( 5) or by the accredited third -party certification body to FDA under proposed  
§ 1.656(c); (4) any food or facility certification issued under this program; (5) any challenge to 
an adverse regulatory audit decision and its disposition; (6) any monitoring it conducted of a 
certified eligible entity; (7) the auditor’s/certification body’s self -assessments and corrective 
actions; and (8) any significant change to the auditing and certification program that might affect 
compliance with this rule.  
On our own initi ative, we are requiring under § 1.658(a)(3) the maintenance of any 
laboratory testing records and results and documentation demonstrating that such laboratory is 
accredited in accordance with § 1.651(b)(3).  
(Comment  138)  Some comments recommend that we al low accredited third -party 
certification bodies to maintain their records in languages other than English, coupled with a 
requirement to provide an English language translation upon FDA request.  Some comments 
suggest that we should allow for flexibility i n the timeline for submission of translated records in 198 
the regulations, rather than establishing a specific deadline, because the circumstances of each 
records request will dictate what would be appropriate --e.g., where there is a recall involving a 
certif ied facility, then the timeframe for providing translations should be very stringent, but 
where records are requested for routine verification purposes, the accredited third -party 
certification body should have more time to comply.  Other comments note tha t a minimum of 5 
business days would be required for English language translations of records.   
(Response  138)  We agree that records should not be required to be maintained in 
English, for the same reasons as we explained in Response 64 (regarding the records of 
recognized accreditation bodies) and are revising § 1.658 accordingly.  We further agree with 
comment s suggesting that we should have a flexible, rather than a fixed timeline for providing 
English language translations of requested records to FDA and are requiring translations to be 
provided within a reasonable time after an FDA request.   
(Comment  139)  Some comments urge us ensure that § 1.658 fully incorporates the 
limitation on access to reports and documents relating to consultative audits in section 
808(c)(3)(C) of the FD&C Act.  
(Response  139)  Section 808(c)(3)(C) of the FD&C Act states that reports  or other 
documents resulting from a consultative audit are accessible to us only under circumstances that 
meet the requirements for records access under section 414 of the FD&C Act.  Proposed 
§ 1.658(a)(1) utilizes the language of section 808(c)(3)(C) of the FD&C Act in describing the 
types of records of consultative audits that an accredited third -party certification body must 
maintain, and proposed § 1.658(b) states that those records must be made available to FDA in 
accordance with 21 CFR part 1 , subpar t J, which implements section 414 of the FD&C Act.  
Therefore, the requirements in § 1.658 do fully incorporate the limitation on access to reports 199 
and documents relating to consultative audits as specified in section 808(c)(3)(C) of the FD&C 
Act.  
(Commen t 140)  Some comments urge us to ensure that trade secrets and confidential 
commercial information contained in any records submitted to FDA would be adequately 
protected.  The comments note that the proposed rule does not contain language on the protection 
of trade secrets, such as the language in 21 CFR parts 120 and 123 indicating that HACCP plans 
are trade secrets exempt from disclosure.  Other comments suggest that FDA should consider 
examining accredited third -party certification body records  without taking custody of them.  The 
comments further suggest that FDA should establish an administrative process for requesting 
records from accredited third -party certification bodies participating in the program.  
Some comments urge us to clarify that w e will not be applying the records access and 
submission requirements of subpart M to audits that are not conducted under the rule or to 
records of the audited food facilities.   
(Response  140)  We acknowledge concerns about protecting proprietary informat ion and 
are adding § 1.695 to address disclosure issues ( see Section XIII.F) . 
We decline the suggestion to review records of accredited third -party certification bodies 
without taking custody of the records, because such an approach would be inconsistent w ith the 
records provisions in section 808(c)(3)(B) of the FD&C Act and would undermine the credibility 
of the program.  We also decline the suggestion to establish separate administrative processes for 
handling records requests that might include, for exam ple, procedures for challenges to records 
requests and appealing adverse decisions on records requests.  Establishing and administering a 
process for FDA records requests would hinder our program oversight and would be overly 
burdensome.  We note that in t his rulemaking, FDA has established a number of mechanisms to 200 
address challenges to FDA’s decisions, including § 1.691 (for requests for reconsideration of the 
denial of an application of waiver request); § 1.692 (for internal agency review of the denial o f 
an application or waiver request upon reconsideration); and § 1.693 (for regulatory hearings on 
withdrawal of accreditation).   
We recommend third -party  certification bodies to fully consider the program 
requirements before deciding to pursue recognition  under the voluntary third -party certification 
program.  Once accredited a certification body may voluntarily relinquish its accreditation under 
§ 1.665 . 
We note that the records maintenance and access requirements of subpart M apply only to 
records relati ng to an accreditation of a third -party certification body under this rule and to the 
audits and certification activities conducted under this program.  Records of audits or 
certifications issued by an accredited third -party certification body for any othe r purpose outside 
of the scope of the program under subpart M are not covered by § 1.658.  We also note that the 
rule does not affect the records maintenance and access requirements that apply to facilities 
under subpart J of this part.  
X.  Comments on Procedures for Accreditation of Third -Party Certification Bodies Under this 
Subpart  
A.  Where Do I Apply For Accreditation or Renewal of Accreditation by a Recognized 
Accreditation Body  and What Happens Once the Recognized Accreditation Body Decides on My 
Application ? (§1.660)  
Proposed § 1.660 states that auditors/certification bodies must apply directly to a 
recognized accreditation body for accreditation (except for circumstances meeting the 
requirements of §  1.670 for direct accreditation).   201 
On our own in itiative, we are adding new provisions (b) through (d) to § 1.660 to explain 
what happens when a third -party certification body’s renewal application is denied.  We are 
adding provisions to clarify what the applicant must do, the effect of denial of an app lication for 
renewal of accreditation on food or facility certifications issued to eligible entities, and how FDA 
will notify the public.  
(Comment  141)  Some comments propose that we include a time limit for recognized 
accreditation bodies to issue an accreditation decision.  They argue a time limit would set 
measurable standards for the process and would also help ensure an adequate supply of 
accredite d auditors/certification bodies.  Comments suggest the timeframe be 90 days.  Some 
comments suggest the timeframe could be stipulated in the Model Accreditation Standards.   
(Response  141)  We acknowledge the interest in having timely accreditation decisio ns.  
However, the comments failed to provide an adequate basis to support a decision to impose a 90 -
day deadline for decisions on accreditation.   No other information available to FDA provides an 
adequate basis for us to establish such a deadline, nor do w e think it would be appropriate to do 
so at this time.  We expect that the time required to perform various actions in the program will 
be longer in the early days of the program than it will when FDA, the accreditation bodies, and 
the third -party certific ation bodies gain experience with the program.   
We decline to revise these regulations to impose a deadline for accreditation decisions, 
but may consider addressing the issue of deadlines for accreditation decisions in guidance, if we 
later determine it w ould be appropriate.  We are mindful that section 808(c)(1)(C) of the FD&C 
Act requires revocation of recognition for failure to comply with the applicable requirements of 
the FD&C Act and FDA regulations.  We would not want an accreditation body to take s hortcuts 
in accreditation assessments to ensure that it could meet a regulatory deadline for its 202 
accreditation decisions out of concern for revocation for failure to comply with the deadline.  
The final rule reflects our view that the rigor of the accredit ation assessment is essential in 
helping to ensure the credibility and success of the third -party certification program.   
(Comment  142)  Some comments ask whether the processes for accreditation are the 
same for governmental and private bodies.  
(Response  142)  Section  808(c)(1)(A) and (B)  of the FD&C Act establishes different 
requirements for public certification bodies and for private certification bodies  by specifying 
different criteria for the assessment of foreign governments/agencies than it does for foreign 
cooperatives and other private third -party certification bodies seeking accreditation.  However, 
the statute makes no distinction between public and private certification bodies in procedural 
matters for accreditation.  Therefore, we are establishi ng a single set of accreditation procedures 
in this rule that apply to both public and private third -party certification bodies.  
(Comment  143)  Some comments ask how a third -party certification body could apply for 
accreditation under this program.  
(Respon se 143)  Third -party certification bodies seeking to apply for accreditation under 
our program may wish to review § 1.660 of this final rule, which describes the general 
procedures for applying for accreditation from a recognized accreditation body, as wel l as the 
eligibility requirements for certification bodies seeking accreditation in §§ 1.640 through 1.645.  
We will post on the FDA Web site a list of all recognized accreditation bodies and will include a 
description of the scope of recognition of each.   
As provided in §  1.670(a)(3), FDA will announce on our Web site if we determine that 
the conditions for direct accreditation by FDA in section 808(b)(1)(A)(ii) of the FD&C Act have 
been met.  We will accept applications for direct accreditation or renewal of direct accreditation 203 
only if we determine that we have not identified and recognized an accreditation body to meet 
the requirements of section 808 of the FD&C Act within 2 years after establishing the program.  
Unless and until FDA makes such a determination, third -party certification bodies must apply for 
accreditation from an accreditation body that FDA has recognized.  
(Comment  144)  Some comments suggest that third -party certification bodies who 
receive an adverse decision on accreditation fro m a recognized accreditation body should have 
access to a competent, independent person outside the recognized accreditation body to whom 
they could appeal.    
Other comments contend that we have the authority to challenge the decisions of an 
accreditation  body.  
(Response  144)  As explained in Response 36, we are revising §  1.620(d)(2) to require a 
recognized accreditation body must use competent persons, who may be external to the 
accreditation body, for investigating and deciding on certification body cha llenges to an adverse 
accreditation body decision.  Such competent persons must meet the following  criteria:  (1) Are 
free from bias or prejudice; (2) did not participate in the accreditation decision being appealed; 
and (3) are not subordinate to a person who participated in such accreditation decision.  Although 
we are not requiring the accreditation body to use an external party for certification body 
appeals, we believe the enhanced requirements of §  1.620(d)(2) will be a dequate to ensure any 
person the accreditation body would select for investigating and deciding on appeals --whether 
internal or external --would be objective and independent.  
With respect to comments suggesting that we should exercise our authority over 
recognized accreditation bodies to challenge their accreditation decisions, we note that the 
enhanced requirements in § 1.620(d) align with the impartiality provisions in part 16, which 204 
contains the regulations for FDA regulatory hearings that we will general ly apply under §  1.693 
to an appeal of a revocation or withdrawal.  We also note that FDA retains the authority to 
revoke the recognition of accreditation bodies for good cause under § 1.634(a)(4) for failure to 
comply with this rule.  For these reasons, w e decline to establish a process appealing recognized 
accreditation body decisions to FDA.  
B.  What is The Duration of Accreditation  by a Recognized Accreditation Body ? (§ 1.661)  
Proposed § 1.661 states that the accreditation of a third -party certificatio n body may be 
granted for a period up to 4 years.   
(Comment  145)  Most comments agree with our proposed maximum 4 -year accreditation 
timeframe.  In this regard, some comments state they are comfortable with this length of time as 
long as accreditation bod ies annually review the accreditation.  Some comments contend that 
instead of allowing accreditation to last “up to 4 years,” we should establish a definite duration 
period and it should be 5 years.  These comments contend that would align the duration of 
accreditation with the duration of recognition.  They also argue that having a definite duration 
period would be more viable administratively.  
(Response  145)  We agree with the comments supporting our proposal to allow 
accreditation to be issued for a term  of up to 4 years.  The comments suggesting accreditation 
should be granted for 5 years offered no information that would provide an adequate basis for 
extending accreditation such that a third -party certification body could be accredited for as long 
as a recognized accreditation body.  We note that the rigor and credibility of the program rests, in 
part, on the extent of oversight of accredited third -party certification bodies.  Through the 
renewal process, recognized accreditation bodies (and FDA, for dir ectly accredited third -party 
certification bodies) look closely at all aspects of a certification body’s and performance and 205 
have the opportunity to decide anew whether the certification body meets the eligibility 
requirements.  
With respect to comments sug gesting that we establish a definite duration of accreditation 
that would apply to any third -party certification body accredited under the program, we 
acknowledge the advantages that certainty provides and, where appropriate, we expect that 
recognized accr editation bodies will issue accreditation for the maximum duration of 4 years.  
Where, for example, a certification body has little or no experience conducting audits assessing 
the safety of food, a recognized accreditation body (or FDA under direct accred itation) may 
decide the initial grant of accreditation should be less than 4 years.  A recognized accreditation 
body (or FDA under direct accreditation) will make its own decision on whether to approve a 
third -party’s application for accreditation and has the flexibility to issue accreditation for a 
duration it believes appropriate, up to a 4 -year maximum established by this rule.  
C.  How Will FDA Monitor Accredited Third -Party Certification Bodies? (§ 1.662)  
We propose d in § 1.662 to monitor directly accr edited certification bodies annually; we 
propose d to evaluate certification bodies accredited by a recognized accreditation body by not 
later than 3 years after the date of accreditation for a 4 -year accreditation term or by no later than 
the mid -term poin t of a less -than-4-year accreditation term.  We propose d to review a variety of 
records and information such as assessments by a recognized accreditation body, information 
regarding the auditor’s/certification body’s qualifications, and information obtained during onsite 
observations.  We propose d to conduct ou r evaluation through onsite observations of 
performance during a food safety audit of an eligible entity or through document review.  
(Comment  146)  Some comments advocate for more clarity on the frequency and 
methods by which we’ll be providing oversight o f accredited third -party certification bodies.  206 
Some comments question whether we have sufficient resources to conduct onsite observation at 
any specific frequency.  They advise that we further explain how we are going to provide 
oversight and how complian ce will be reported.  
(Response  146)  Monitoring assessments of accredited third -party certification bodies  are 
one of several tools we will use for program oversight.  Section 1.662(a) implements section 
808(f) of the FD&C Act, which states that FDA must e valuate an accredited third -party 
certification body  periodically, or at least once every 4 years, and take any other measures FDA 
deems necessary to ensure compliance.  We anticipate that information gleaned from other 
monitoring tools, such as the accred itation body’s annual assessment of the certification body , 
will also aid in program oversight and may perform additional assessments of certification 
bodies  in certain instances.   
The objective of an  assessment under § 1.662 will be to determine the accr edited third -
party certification body’s compliance with the requirements of this rule.  FDA may conduct an  
assessment through a site visit of the third -party certification body’s headquarters, onsite 
observation of an accredited third -party body’s perform ance during a food safety audit,  
document review, or a combination of these activities.  We will develop plans for assessing 
accredited third -party certification bodies based on risk and informed by data and other 
information available to FDA regarding th eir programs and performance in our program.  The 
starting point for each assessment will be document review, and any additional assessment 
activities (e.g., site visits or onsite observations) will be conducted where circumstances may 
warrant or for spot -checks of randomly selected third -party certification bodies.  When planning 
an assessment, we will establish the time period of activities covered by the assessment.  We 
may request records of the certification body  under § 1.658.  We also may develop pla ns for any 207 
site visits or onsite observations, including locations to be visited .  As part of the assessment, we 
may review records relating to conflicts of interest , and interview officers, employees , and audit 
agents, and other agents who participate in decisions on issuance of certification under this 
program.  We are revising this section to explicitly state that FDA may visit the certification 
body’s headquarters or other locations where audit agents are managed.  
(Comment  147)  Some comments propose a lternative schedules for FDA monitoring of 
accredited third -party certification bodies.  Some comments propose that if we revise the final 
rule to establish a fixed, 5 -year duration for accreditation, we should monitor accredited third -
party certification bodies not later than 4 years after the date of accreditation.  Other comments 
state that we should conduct our own assessments of certification bodies accredited by 
recognized accreditation bodies every 3 years.  Still other comments ask who will cover th e costs 
of such assessments.  
(Response  147)  As explained in Response 145, we decline the suggestion to lengthen the 
maximum duration of accreditation from 4 years to 5 years.  We will use annual performance 
assessments by recognized accreditation bodies and information submitted to FDA as part of our 
ongoing monitoring of accredited third -party certification bodies.  The FDA monitoring 
assessment under § 1.662 will occur at least once every 4 years and may occur more frequently 
depending on circumstances, including available resources.  We are proposing that costs for 
FDA monitoring will be included in the user fees that are assessed under section 808(c)(8) of the 
FD&C Act to recover FDA’s costs in administering the program  (80 FR 43987 ).   
(Comment  148)  Some comments propose that FDA monitoring of accredited third -party 
certification bodies should periodically focus on compliance with food additive requirements.  208 
(Response  148)  Our monitoring will be tailored to the scope of accreditation under 
which t he accredited third -party  certification body may conduct food safety audits under this 
program. We will prioritize our monitoring activities to ensure compliance with the requirements 
of section 808(f)(2) based on factors such as our risk -based program pri orities.  
(Comment  149)  Some comments suggest that, in addition to conducting onsite 
observations of accredited certification bodies when conducting a food safety audits, we could 
also do so when the recognized accreditation body assesses the auditor/certi fication body.   
(Response  149)  We agree and will do so as appropriate and as circumstances allow.  
(Comment  150)  Comments suggest that when FDA selects an accredited certification 
body for onsite observation, we should notify it 2 months in advance, to a llow time to make the 
arrangements.  
(Response  150)  At this time, we have no basis for determining that we would be able to 
provide 2 months’ notice prior to each certification body onsite observation; therefore, we 
decline the suggestion.   We note that we  may begin working with an accredited third -party 
certification body well before we perform onsite observations, as feasible.   
D.  How Do I Request an FDA Waiver or Waiver Extension F or the 13 -Month Limit For Audit  
Agents Conducting Regulatory Audits? (§ 1.663)  
Proposed § 1.663 would allow accredited third -party certification bodies to seek an FDA 
waiver of the limit on audit agents conducting regulatory audits of an eligible entity where they 
conducted a regulatory or consultative audit in the preceding 13 months.  Under section 
808(c)(4)(C)(ii) of the FD&C Act, we may waive the limit, which appears in § 1.650(c), where 
there is insufficient access to accredited certification bodies in the country or region where an 
eligible entity is located.   209 
Of our own initiative, we are clarifying in the final rule that the s howing of insufficient 
access is based on lack of audit agents (or in case where accredited third -party certification 
bodies are comprised of an individual, that individual), consistent with changes made to §  1.650 
(see Section IX.A).  
(Comment  151)  Some c omments note that capacity issues are currently problematic, 
even in regions with highly developed third -party food safety auditing systems, and are likely to 
increase once the FSMA rules are implemented.  Some comments contend that we should allow 
the req uest for the waiver to come from other affected parties in addition to accredited 
certification bodies.  In particular, comments suggest we should allow the requests to come from 
a foreign supplier and/or the importer.  Some comments estimate that, with th e increased demand 
from FSMA for audit services, it will take time for capacity to expand sufficiently to satisfy the 
increased demand.  Accordingly, they urge us to act expeditiously on waiver and waiver 
extension requests.  Other comments express concern  that FDA will be overwhelmed with 
waiver requests and urge FDA to develop a process for expedited issuance of waivers.   
(Response  151) We acknowledge the concerns and are aware capacity is an issue the food 
industry and certification bodies currently face.  However, we decline the suggestion to allow 
importers and foreign suppliers to seek waivers on behalf of an accredited certificatio n body, 
because we believe the certification body is better positioned to determine its own capacity than 
an importer or foreign supplier would be.  Further, it would ultimately be the certification body’s 
choice regarding whether to take on additional aud iting work.  If an accredited third -party 
certification body concluded it needed a waiver to be able to perform a particular audit, the 
certification body would be motivated to seek a waiver.   210 
We agree with the comments suggesting it will take time to bui ld adequate food safety 
auditing capacity around the world and will be prepared to act on waiver requests as 
expeditiously as possible.  It is difficult to estimate the amount of the time required to process 
waiver requests, because the program has not lau nched.  We anticipate that we will be able to 
process most waiver requests within 15 business days, as permitted by resources and other 
program activities.  In response to comments suggesting that we should prioritize certain types of 
waiver requests, we h ave modified the first -in, first -out rule of § 1.663 (d) to allow specific 
waiver requests to be prioritized based on program needs.  
We also note that as we gain experience with the program and with information offered 
in support of waiver requests, we expe ct to be able to process waiver requests more quickly and 
may reevaluate whether FDA has adequate information to support issuance of a waiver for a 
particular country or region.  
E.  When Would FDA Withdraw Accreditation? (§ 1.664)  
Proposed § 1.664 would e stablish the conditions under which we could withdraw 
accreditation from a third -party certification body, regardless of whether it was directly 
accredited or accredited by a recognized accreditation body.  This section would implement 
section 808(c)(6)(A)  of the FD&C Act, which requires us to withdraw accreditation in certain 
outbreak situations, whenever we find that an accredited third -party certification body is no 
longer meeting the requirements for accreditation, or following a refusal to allow U.S. o fficials 
to conduct audits and investigations to ensure compliance with these requirements.  The statute 
directs us to withdraw accreditation if a food or facility certified by an accredited third -party 
certification body under our program is linked to an outbreak of foodborne illness that has a 
reasonable probability of causing serious adverse health consequences or death in human or 211 
animals.  There is an exception if we conduct an investigation of the material facts of the 
outbreak, review the steps and a ctions taken by the third -party certification body, and determine 
that the accredited third -party certification body satisfied the requirements for issuance of 
certification under this rule.  
Section 808(c)(6)(B) of the FD&C Act allows us to withdraw accre ditation from an 
accredited third -party certification body whose accrediting body had its recognition revoked, if 
we determine there is good cause for withdrawal.  This statutory provision is reflected in 
proposed § 1.664(c), which also provides two exampl es of circumstances we believe provide 
good cause for withdrawal, including bias or lack of objectivity and performance calling into 
question the validity or reliability of its food safety audits and certifications.  
In proposed § 1.664(d) we provide for re cords access when considering possible 
withdrawal of accreditation.  In proposed § 1.664(e) we provide for notice of withdrawal of 
accreditation and describe the processes to challenge such withdrawal.   
Proposed §  1.664(f) describes the effect of withdraw al on eligible entities.  Proposed 
§ 1.664(g)(1) explains that FDA will notify the recognized accreditation body that accredited the 
third -party certification body whose accreditation wa s withdrawn by FDA.  Proposed 
§ 1.664(g)(2) explains that FDA may revo ke recognition of an accreditation body whenever FDA 
determines there is good cause for revocation under proposed § 1.634. Proposed § 1.664(h) 
provides for public notice of withdrawal of accreditation on FDA’s Web site.  
At our own initiative, we revised pr oposed § 1.664(c) on discretionary withdrawal of 
accreditation to allow for partial withdrawal of accreditation.  For example, if FDA reviews a 
self-assessment submitted by an accredited third -party certification body following revocation of 
its accreditat ion body’s recognition and determines the third -party certification body has failed to 212 
perform food safety audits consistent with this rule in some but not all areas for which it is 
accredited, FDA may partially withdraw the third -party certification body’ s accreditation as to 
those areas in which it has failed to comply with this rule.  
(Comment  152)  Some comments contend that FDA’s interpretation of the statutory 
mandatory withdrawal provisions in section 808(c)(6)(A) of the F D&C Act is overly strict.  T he 
comments focus specifically on mandatory withdrawal when an eligible entity that was issued 
certification by an accredited third -party certification body is linked to a foodborne illness 
outbreak that meets the SAHCODHA standard.   The comments argue tha t one adverse event 
does not necessarily mean the third -party certification body should lose its accreditation, 
emphasizing that a single certification body might conduct hundreds of audits in various regions 
of the world and in diverse product areas.  The comments propose that we limit mandatory 
withdrawal following an SAHCODHA outbreak to the country, region, type of food product and 
process involved in the event.  
Some comments agree that, as described in proposed § 1.664(f), certifications issued by a 
third-party certification body prior to withdrawal of its accreditation should remain in effect until 
they expire.  Other comments assert that withdrawal of accreditation might result in unfairly 
revoking a significant number of certifications at tremendous  cost, adversely affect other eligible 
entities that depend on the certification body and its certifications, and disrupt the marketplace.  
Still other comments request greater detail on the withdrawal procedures.   
(Response  152)  We believe the concerns about mandatory withdrawal of accreditation in 
the outbreak situation described above or similar situations are satisfactorily in addressed in 
§ 1.664(b), codifying section 808(c)(6)(C) of the FD&C Act, which allows FDA to waive 
mandatory withdrawal if FDA  investigates the material facts of the outbreak, reviews the steps 213 
and actions taken by the certification body, and determines that the certification body satisfied 
the criteria for issuance of certification under this subpart.   
Regarding the comments ex pressing concerns about the possible adverse effects of 
withdrawal of accreditation on certifications issued by the certification body to other eligible 
entities, we note that § 1.664(f) states that certifications issued by an accredited third -party 
certif ication body prior to withdrawal of accreditation by FDA will remain in effect until they 
expire, except that FDA may refuse to consider a certification under sections 801(q) or 806 of 
the FD&C Act if FDA has reason to believe such certification is not val id or reliable.   
The comments seeking additional detail on our withdrawal procedures did not specify 
what areas of § 1.664 required further explanation.  We believe the procedures described in 
§ 1.664 offer sufficient detail for interested parties to unde rstand the standards for withdrawal of 
accreditation by FDA and the processes involved.  
(Comment 153)  Some comments suggest that a recognized accreditation body, not FDA, 
should withdraw accreditation from a certification body it accredited, except for certification 
bodies directly accredited by FDA.   Other comments urge us to include a requirement, in 
§ 1.634(a), for FDA to consult with the appropriate accreditation body before withdrawal of an 
accreditation it had issued.  The comments argue that consu ltation would facilitate coordination 
with the recognized accreditation body and would complement § 1.664(c), which addresses 
discretionary withdrawal of accreditation in the event we revoke our recognition of the 
accrediting accreditation body.   Other com ments recommend that we meet with the certification 
body’s accrediting body when considering possible withdrawal of accreditation and that we 
allow for a formal appeal process.   214 
(Response  153)  We disagree with the comment asserting that only accreditatio n bodies 
may withdraw accreditations of certification bodies they have accredited, as FDA is mandated 
under section 808(c)(6) of the FD&C Act to withdraw accreditation of a certification body under 
the conditions set forth in the section, subject to the wa iver provision in 808(c)(6)(C).  We note 
that a third -party certification body whose accreditation was withdrawn by FDA may appeal the 
action by requesting a regulatory hearing under § 1.693.  We further note that a recognized 
accreditation body has far br oader authority to suspend, withdraw, reduce, or otherwise dispose 
of an accreditation it issued, than FDA does under section 808(c)(6)  of the FD&C Act .  Even in 
circumstances that meet the statutory criteria for withdrawal of accreditation, FDA believes i t 
generally would not need to initiate withdrawal unless the recognized accreditation body failed 
to withdraw the certification body’s accreditation in a timely manner.  
We agree that in some cases, consultation with a certification body’s accrediting body  
before withdrawal could have advantages to FDA and the accreditation body, if circumstances 
allow.  Decisions on whether to consult with the certification body’s accrediting body prior to 
withdrawal will be made on a case -by-case basis.  Consultation migh t not be appropriate if, for 
example, the facts that support withdrawal of the third -party certification body’s accreditation 
also support revocation of the accreditation body’s recognition.   
(Comment  154)  Some comments ask how individual holders of food  or facility 
certificates would be made aware of the withdrawal of accreditation of the third -party 
certification body that issued the certificate.  Other comments recommended that FDA post on its 
Web site not only that fact that a certification body’s acc reditation has been withdrawn, but also 
the reason for the withdrawal.   215 
(Response  154)  If we withdraw accreditation of any third -party certification body, 
whether accredited by a recognized accreditation body or by FDA through direct accreditation, 
we wi ll post information regarding the withdrawal, including a description of the basis for the 
action, on the FDA Web site pursuant to § 1.664(h).  We do not intend to contact each eligible 
entity that was issued a certification by the third -party certificatio n body because, as indicated in 
Response 152, certifications issued to eligible entities prior to withdrawal of accreditation will 
remain in effect until they expire, except where FDA has reason to believe the certification is not 
valid or reliable and on that basis may refuse to consider the certification under sections 801(q) 
or 806 of the FD&C Act.   
(Comment  155)  Some comments recommend we use ISO \IEC 17011 :2004  as the 
reference document for the requirements of this section.  
(Response  155)  We decline the suggestion, because the grounds for withdrawal under 
section 808(c)(6) of the FD&C Act are much broader than those described in ISO/IEC 
17011:2004 (Ref. 5).  For example, under  section 808(c)(6)(A)(i) and (C) of the FD&C Act FDA 
may withdraw  accreditation of a certification body if a food or facility it certified under our 
program is linked to an outbreak of foodborne illness that has a reasonable probability of causing 
SAHCODHA, unless FDA determines the certification body satisfied the requ irements for 
issuance of such certification.  In such an outbreak situation, the statute contemplates that 
withdrawal of accreditation would occur after a single --albeit significant --failure by the 
certification body.  By contrast ISO/IEC 17011:2004 allows for withdrawal of accreditation only 
when a certification body persistently fails to meet the requirements of accreditation or abide by 
the rules of accreditation.   216 
We note that by declining to revise § 1.664 based on the comments, we are not 
suggesting that FDA will withdraw accreditation when the Agency identifies a single incident or 
mistake by a certification body, except where required by the statute.  Any decision to withdraw 
accreditation will be based on the facts and circumstances of the situation and following due 
consideration by FDA.    
(Comment  156)  Some comments state that in a case where FDA withdraws an accredited 
certification body , the accreditation body should make an investigation and analysis and submit 
the analysis result to FDA within 3 months after the analysis report has been established.  
(Response  156)  We disagree.  This rule does not require that the accreditation body 
make a full investigation and analysis and submit the analysis result to FDA within 3 months.  
Section 1.664(g) requires the accreditation body to perform a self -assessment and report the 
results of the self -assessment to FDA within 60 days.  FDA may revoke the recognition of an 
accreditation b ody whenever FDA determines there is good cause for revocation of recognition 
under § 1.634.  These procedures will help ensure that accreditation bodies remain in compliance 
with the requirements of the third -party program.  
F.  What if  I Want  to Voluntar ily Relinquish Accreditation or Do Not Want To Renew 
Accreditation ? (§ 1.665)  
Proposed § 1.665 offers a mechanism for an accredited third -party certification body to 
voluntarily relinquish its accreditation before it terminates by expiration.  
Although  we received no adverse comments on this section , we received comments on 
other sections of the rule that led us to  identif y a gap in procedural requirements when an 
accredited certification body  decides to allow its accreditation to expire without renewing it.  At 
our own initiative, we are revising the voluntary relinquishment provisions in § 1.665 to also 217 
address situations where a certification body  decides it does not want to renew its accred itation 
once it expires.  
G.  How Do I Request Reaccreditation ? (Proposed § 1.666)  
Proposed § 1.666 describes the procedures a certification body must follow when seeking 
to be reaccredited after its accreditation was withdrawn by FDA or after voluntarily r elinquishing 
its accreditation.  
FDA received no adverse comments on this section . On our own initiative we are 
revising paragraph (a)(2)(i) to conform to the changes in §  1.634(d) to clarify that the third -party 
certification body has to become accredited by another accreditation body or by FDA through 
direct accreditation no later than 1 year after the withdrawal or accreditation, or the original date 
of expiration of the accreditation, whichever comes first . 
XI. Comments on Additional Procedures for Direc t Accreditation of Third -Party Certification 
Bodies Under this Subpart  
A.  How Do I Apply to FDA for Direct Accreditation or Renewal  of Direct Accreditation ? 
(§ 1.670)  
Section 808(b)(1)(A)(ii) of the FD&C Act allows us to directly accredit third -party 
auditors/certification bodies if we have not identified and recognized an accreditation body to 
meet the requirements of section 808 within 2 years after establishing this program.  We 
proposed circumstances and procedures that would apply for direct accredita tion and renewal of 
direct accreditation.  
(Comment  157)  Some comments assert that the statute anticipates a bifurcated system 
for direct accreditation of certification bodies, because the standards for review for accreditation 
of foreign governments are distinct from those of the private auditing entities under section 218 
808(c)(1) of the FD&C Act.  The comments ask that we draft additional rules to specifically 
cover direct accreditation of foreign governments, asserting that we should provide a separate 
path for direct accreditation of foreign governments that prioritizes their applications based on, 
among other things, the language in section 808(c)(1) of the FD&C Act.  Some comments ask 
whether the same eligibility requirements and procedures are required  of both governmental and 
private bodies applying for direct accreditation.  
(Response  157)  We disagree with the suggestion to create a bifurcated system.  We 
acknowledge that section 808(c)(1) of the FD&C Act contains different requirements for foreign 
governments/agencies than it does for foreign cooperatives and other private third -party 
certification bodies seeking accreditation.  However, we do not interpret this language as 
suggesting a preference for public certification bodies over private certifica tion bodies.  
We believe sections 808(c)(1)(A) and (B) of the FD&C Act are tailored to reflect the 
objectives and scope of each type of assessment, which would vary because of the differences 
between public and private certification bodies.  While governmen ts typically are both 
auditors/inspectors and owners of food safety schemes, private certification bodies usually are 
not scheme owners, because of concerns about possible conflicts of interest associated with 
serving in dual roles.  Therefore, a private c ertification body would not be assessed for its food 
safety program or standards; it would be assessed for the training and qualifications of its 
auditors and its internal management system.  In light of the foregoing, we decline the suggestion 
to interpre t sections 808(c)(1)(A) and (B) of the FD&C Act as supporting provisions for direct 
accreditation that would prioritize the applications of foreign governments/agencies over 
applications from private third -party certification bodies.   219 
(Comment  158)  Some comments suggest that FDA should not serve as an accreditation 
body for th ird-party certification bodies  because it would open the door for other countries with 
less capability to do the same.  The comments contend that FDA and its foreign regulatory 
partn ers need to provide the oversight of the industry, but should not be accreditation bodies.  
(Response  158)  We disagree.  Section 808 of the FD&C Act contemplates that FDA can 
provide proper oversight of the program, while directly accrediting third -party c ertification 
bodies.  We are unable to comment on what effects, if any, this would have on the actions of 
other countries.  However, we emphasize that FDA will not perform direct accreditation unless 
the circumstances of section 808(b)(1)(A)(ii) of the FD& C Act are met --that is, if FDA has not 
identified and recognized an accreditation body to meet the requirements of section 808 of the 
FD&C Act within 2 years after establishing this program.   
(Comment  159)  Some comments ask that we wait for more than 2 y ears after the 
program is established to accept applications for direct accreditation, to allow enough time for 
accreditation bodies applying for recognition to satisfy all the necessary requirements.   Other 
comments assert that we should not directly accr edit certification bodies in a country if we have 
already recognized an accreditation body in that country.  Some comments ask us to clarify 
when, under what conditions, and how we would choose to directly accredit a certification body.  
(Response  159)  Under section 808(b)(1)(A)(ii) of the FD&C Act, 2 years after 
establishing the program is the earliest date that FDA may begin to directly accredit third -party 
certification bodies.  Further, we may only do so if we determine that we have not identified  and 
recognized an accreditation body to meet the requirements of section 808 of the FD&C Act 2 
years after establishing the program.   In the proposed rule, we provided examples of how we 
may make this determination, such identifying a type of expertise or  geographic location for 220 
which a recognized accreditation body is lacking, and stated that we will only accept applications 
for direct accreditation and renewal applications that are within the scope of the determination.  
FDA declines to limit itself to a  time period longer than 2 years before it can consider direct 
accreditation as any decision to directly accredit will depend on the circumstances the needs of 
the program, as determined by FDA under §  1.670(a).  
(Comment  160)  Some comments express concern  that we will not have the capacity to 
undertake the responsibility of directly accrediting certification bodies.   
(Response  160)  Section 808(c)(8) of the FD&C Act requires FDA to create a user fee 
program to section 808 of the FD&C Act.  FDA is in the p rocess of establishing this program by 
rulemaking  (80 FR 43987 ).  For more information about the costs of this program, please see the 
regulatory analysis of this final rule.  
(Comment  161)  Some comments ask if we will have a contract agreement with direct ly 
accredited certification bodies.  These comments assert that if we do, the contract should specify 
that we have the capacity to access confidential information without prior written consent of the 
certification body.  The contract should also specify th at having access to records relating to 
accreditation activities under this subpart is necessary to ensure the rigor, credibility, and 
independence of the program.  
(Response  161)  Under § 1.671(d), FDA will list any conditions associated with the 
accredita tion in the issuance and may establish an agreement with the certification body at that 
time.  With respect to access to records, a third -party certification body that is directly accredited 
by FDA must comply with the records maintenance and access requir ements of § 1.658.  
Records obtained by FDA will be subject to the disclosure requirements of § 1.695.   221 
B.  How Will FDA Review my Application  for Direct Accreditation or Renewal  of Direct 
Accreditation  and What Happens Once FDA Decides on my Application ? (§ 1.671)  
Proposed § 1.671 describes a process for reviewing and deciding on applications for 
direct accreditation and renewal that is consistent with the procedures for reviewing and deciding 
on applications under other provisions in this rule.  
On our own initiative we are revising paragraph (a) to clarify that FDA will review 
submitted applications for completeness and notify applicants of any deficiencies.  We also are 
adding new paragraphs ( e) through ( h) to § 1.671  to explain what happens whe n a directly 
accredited certification  body’s renewal application is denied.  We are adding provisions to clarify 
what the applicant must do, the effect of denial of an application for renewal of direct 
accreditation  on food or facility certifications issue d to eligible entities, and how FDA will notify 
the public.  
(Comment  162) Some comments express concern that we are limiting ourselves to a 
“first in, first out” review process that gives us no discretion to accredit foreign governments 
before we consider other applications from private third -party entities that apply.  
Some comments ask that we consider prioritizing approval of applications for direct 
accreditation on areas and regions where it is most needed to benefit our food safety mandates.   
Some comm ents assert that priority for review of applications for direct accreditation 
should be for countries without an accreditation body or in circumstances where it is not 
economically feasible for a national accreditation body to expand its scope to include a  certain 
single certification body.  
(Response  162)  As indicated Response 25, we intend to treat public and private 
certification bodies equally under this program, as both public and private certification bodies are 222 
capable of meeting the requirements of  the program.  Additionally, because we will only be 
accepting applications for direct accredi tation in limited circumstances  as discussed in Responses 
158 and 159, all applications for direct accreditation will need to be able to demonstrate that 
there is  a need for direct accreditation based on a determination made by FDA under 
§ 1.670(a)(1).  We note that we have revised §  1.671(a) to allow FDA to prioritize specific direct 
accreditation applications to meet the needs of the program.  
(Comment  163)  Some comments assert that our application review process must be 
comprehensive but also expedient.  Some comments ask that our communications with 
applicants be timely.  
Some comments express concern about the length of time it will take us to recognize and 
notify an applicant of any deficiencies in the application.  These comments also assert that 
requiring applicants with deficiencies to resubmit their applications and sending it to the bottom 
of the review list would make for significant delays in the direct accreditation and renewal of 
direct accreditation application process.  
(Response  163)  We understand the concern expressed by comments with regard to 
timeliness.  Although we decline to set specific deadlines for this review, FDA anticipates that a 
complet eness determination could generally be made within 15 business days, because this is not 
a decision on the merits of the application.  Nonetheless, the time needed to identify deficiencies 
in any particular individual application will depend on a number of  factors, including the quality 
of the submission, the availability of resources, and other competing priorities at the time the 
application is submitted .  With respect to the concerns about requiring incomplete applications to 
be resubmitted and added to the bottom of the review list, we note that from our experience 
gained from the third -party certification pilot for aquacultured shrimp, extensive followup was 223 
needed with many of the applicants in order to gain sufficient information for a complete 
applic ation.  With this in mind, we are processing only complete applications so that we are not 
delaying others that have correctly prepared complete applications.  Further, we are establishing 
an electronic portal for submission of applications, reports, notifications, and other information 
under this rule and an electronic repository of this information, which will allow us to 
communicate with applicants as needed.   
C.  What is the Duration  of Direct Accreditation ? (§ 1.672)  
We proposed that direct accreditation of a third -party certification body may be granted 
for a period up to 4 years.  We tentatively concluded that 4 years is an appropriate duration for an 
accreditation because we believe the rigor and credibility of this program rests, in part, on the 
oversight of accredited certification bodies to conduct audits and to certify eligible foreign 
entities.  We requested comment on this tentative conclusion.  
(Comm ent 164)  Some comments ask that we establish a specific fixed duration of 5 
years for direct accreditation before renewal is required.  These comments also ask that the 
duration for recognition of accreditation bodies and accreditation of third -party cert ifications 
bodies also be fixed at 5 years and assert that having a standardized accreditation term for all 
parties in the third -party program would be more administratively viable for us.   
(Response  164) For the reasons we explained in R esponse 145  we de cline to establish a 
fixed duration of accreditation and also decline to establish a standard term of 5 years for 
accreditation for all parties in the third -party program.   224 
XII. Comments on Requirements for Eligible Entities Under this Subpart  
A.  How and When Will FDA Monitor Eligible Entities ? (§ 1.680)  
Proposed § 1.680 would allow FDA to conduct onsite audits of eligible entities that have 
received certification from an accredited certification body at any time, with or without the 
accredited third -party certification body present.  It also proposed that a food safety audit by an 
accredited certification body is not considered an inspection under section 704 of the FD&C Act.  
For clarification purposes at our own initiative, we are revising the second sentence of § 1.680(a) 
to add, “[w]here FDA determines necessary or appropriate,” before “the audit may be conducted 
with or without the accredited certification body or the recognized accreditation body (where 
applicable) present.”  
(Comment  165)  Some comments address the timing of FDA’s audits of eligible entities.  
Some comments encourage FDA to conduct audits of eligible entities regularly, particularly in 
the first years of the program, to ensure compliance with the program and to verify that 
certification is appropriate.  Some comments encourage FDA to conduct random as well as 
targeted audits of eligible entities.  For example, the comments suggest that if FDA withdraws 
the accreditation of a certification body, the Agency should conduct onsit e audits of a sample of 
the eligible entities to which the withdrawn certification body issued certifications.  
(Response  165)  We agree that robust government oversight of the third -party  program 
will be vital to its success and periodic audits of eligible  entities will be conducted consistent 
with our risk -based priorities and resources.  
(Comment  166)  Some comments discuss the substance of FDA’s audits of eligible 
entities.  Some of these comments encourage FDA to ensure that eligible entities implement 
corrective actions when deficiencies are identified.  Some comments recommend that company 225 
data on tests of both products and the environment be made available to FDA auditors, and argue 
that without access to such data, FDA auditors would not be able to p erform a thorough audit.  
Comments also maintain that, during an audit, FDA should be able to access results of the 
eligible entity’s testing of both products and the environment.  
(Response  166)  We currently are developing internal operational procedures for the 
third -party certification program and will make these procedures public.  As part of this process, 
we are developing protocols for FDA audits of eligible entities.  
(Comment  167)  Some comments argue that unannounced audits of eligible entities by 
FDA that have been certified by an accredited third -party certification body would likely result 
in incomplete audits and urge the agency to consider contacting the eligible entity to schedule 
such audits.  Comments state that scheduled audits would be more  efficient and less burdensome 
for both eligible entities and FDA because eligible entities would have a better understanding of 
what is needed during the audit and which employees  should be present.  
(Response  167)  Section 808(c)(5)(C) of the FD&C Act di rects FDA to promulgate 
regulations requiring that “audits performed under this section be unannounced.”   Section 
808(f)(3) of the FD&C Act allows FDA to, at any time, conduct an onsite audit of any eligible 
entity certified by an accredited third -party certification body to ensure compliance with the 
requirements of section 808.  Given this statutory language, we are clarifying in § 1.680 tha t an 
FDA audit conducted under this section will be conducted on an unannounced basis and may be 
preceded by a request for a 30 -day operating schedule .  We note that  it may not be appropriate at 
all times to precede audits for a 30 -day operating schedule , such as in the case of a for -cause 
audit.  226 
(Comment  168)  Some comments state that when FDA has questions about eligible 
entities, it should notify the accreditation bodies and certification bodies to conduct a joint audit.  
(Response  168)  It is unclear wh at the comment means by conducting a joint audit, but 
§ 1.680 would allow for the certification body and accreditation body to be present during the 
FDA audit when FDA determines it is necessary and appropriate.  
(Comment  169)  Some comments argue that the monitoring of eligible entities should be 
conducted by the competent authority of the exporting country, particularly where a systems 
recognition agreement is in place or where there is a robust national food control system in place.  
(Response  169)  We in tend to coordinate as appropriate with our foreign regulatory 
counterparts; however, section 808(f)(3) of the FD&C Act specifically directs FDA to conduct 
onsite audits of eligible entities to ensure compliance with the requirements of section 808  of the 
FD&C Act .  We believe onsite audits of certified eligible entities are an important component of 
the robust oversight essential to the success of the third -party  program.  Without the ability to 
conduct onsite audits of a certified eligible entity, FDA woul d not be able to directly ascertain 
whether the certification body and/or its accreditation body are in fact making accurate 
determinations of compliance with FDA requirements.  Such oversight is necessary to maintain 
confidence in the certifications issue d by accredited certification bodies under this program.  
(Comment  170)  Some comments ask FDA to clarify why an onsite audit of an eligible 
entity is not considered an inspection under section 704 of the FD&C Act, particularly since the 
purpose of the audi t is to determine if the entity is in compliance with the FD&C Act and since 
an FDA inspection may be used to meet the verification requirements under the proposed FSVP 
regulation. Other comments endorse FDA’s decision not to consider a food safety audit u nder 
this program an inspection under section 704 of the FD&C Act.  227 
(Response  170)  Section 808(h)(1) of the FD&C Act explicitly states that audits under the 
third -party  certification program “shall not” be considered inspections under section 704.  The 
inspections done under section 704 of the FD&C Act, unlike audits conducted under section 
808(f)(3), are not conducted for the purpose of ensuring compliance with section 808 of the 
FD&C Act.  The objective of an audit under § 1.680(a) extends beyond the elig ible entity --
through its audit of the eligible entity FDA is gathering information to use in its monitoring of 
the accredited certification body that audited the entity and the recognized accreditation body 
that accredited certification body that audited t he eligible entity.  We note that an audit under 
section 808(f)(3) is not a “food safety audit” under this subpart.  As noted previously, the audits 
conducted under section 808(f)(3) are done specifically to ensure compliance with section 808 of 
the FD&C Act.  As discussed in section III.C. , we are clarifying that an audit conducted under 
this subpart is not an inspection under section 704 under the FD&C Act.  Accordingly, we are 
removing § 1.680(b).  
B.  How Frequently Must Eligible Entities be Recertified ? (§ 1.681)  
Proposed § 1.681 stated that an eligible entity seeking to maintain its facility certification 
must seek recertification prior to expiration of its certification.  It also proposed that under 
section 801(q)(4)(A) of the FD&C Act, FDA could requi re, at any time we deem appropriate, 
that an eligible entity renew a food certification.  
We received no comments on this proposed section.  However, to clarify certain matters, 
we are amending this section on our own initiative.  We are adding to first sen tence the words, 
“food or” before “facility certification” because the maximum duration of certifications under 
section 808(d) of the FD&C Act applies to both food and facility certifications.  Additionally, we 228 
are revising this section to state that FDA c an require an eligible entity to apply for 
recertification of both food and facility certifications at any time that FDA deems appropriate.   
XIII. Comments on General Requirements of This Subpart  
A.  How Will FDA Make Information About Recognized Accreditation Bodies  and Accredited 
Third -Party Certification Bodies Available to the Public ? (§ 1.690)  
We proposed to post on our Web site a registry of recognized accreditation bodies and of 
accredited  third -party certification bodies, including the name and contact information for each.  
The registry may provide information on certification bodies accredited by recognized 
accreditation bodies through links to the Web sites of such accreditation bodies.  We requested 
comment on our proposed public reg istry.  
(Comment  171)  Some comments support our proposal to place a registry of recognized 
accreditation bodies and accredited certification bodies on our Web site and to provide links to 
the Web sites of recognized accreditation bodies.  Some comments ass ert that such a web -based 
resource where members of the industry and public could access standards associated with 
accreditation/certification and a list of accreditation and certification bodies is a meaningful 
demonstration of FDA oversight.  Some commen ts ask that this list be updated regularly so that 
it stays accurate.  These comments also ask that we provide appropriate indexing and filtering 
functions so that the registry is easily searchable and stakeholders can conveniently and reliably 
find and us e this information.  
(Response  171) FDA agrees that the online registry will be a valuable tool.  We intend 
for it to be updated regularly.  We also intend for it to have indexing and filtering functions 
which will make searches more efficient and producti ve.  229 
(Comment  172) Some comments ask that we not include the name(s) of audit agent(s) on 
our Web site or otherwise publicly disclose such information could disrupt the marketplace for 
third -party certification services  
Some comments assert that access to detailed, specific, and sensitive information is not 
necessary to gain credibility with consumers.  These comments refer us to industry models that 
provide detailed information on the requirements of their program and posts a list of members in 
good standi ng along with a list of companies who have been decertified is an example of 
credible, balanced information that is actionable by consumers (i.e., California Leafy Green 
Products Handler Marketing Agreement).  
(Response  172)  To clarify, we do not intend to  disclose the names of audit agents on our 
Web site.  We will be providing the business name and business contact information for each 
recognized accreditation body.  The business name and business contact information for each 
accredited third -party certif ication body may be listed on our Web site or may be provided by 
link to Web sites of their accreditation bodies.  The Web site will contain program information as 
well and may be similar to the industry models recomme nded by some comments.  
(Comment  173) Some comments seek maximum transparency, asserting that we must 
also post on our Web site the audit reports, self -assessments, and notifications prepared by the 
third -party  certification bodies and submitted to FDA.  The comments contend that making this 
information public would increase program transparency and help to ensure that imported 
products do not receive an unfair competitive advantage over products available domestically.  
Other comments suggest that we allow accreditation bodies and third -party certification 
bodies to submit redacted versions of these documents, where confidential information is 
blacked  out, so that these documents can also be made publicly available without compromising 230 
confidential information.  These comments assert that makin g public these reports, self -
assessments, and notifications would improve self -assessments, reduce the Agency’s burden of 
responding to FOIA requests, and allow independent analysis to complement the Agency’s 
evaluation.   Thus, comments ask us to specify i n § 1.690 that we will also place on our Web site 
the reports and notifications submitted pursuant to §§  1.623 and 1.656 and that we will allow a 
recognized accreditation body and accredited auditors/certification body to submit a redacted 
version of the r eport or notification that is intended to be made publicly available.  
(Response  173)  Generally, we do not intend to post redacted versions of reports on our 
Web site.  Information submitted to the Agency, including reports and notifications submitted 
pursuant to §§  1.623 and 1.656, becomes an Agency record.  We have added a new § 1.695 to 
the final rule to clarify that records under this subpart are subject to part 20;  part 20 provides 
protections for trade secrets and confidential commercial information ( CCI) from public 
disclosur e (see, e.g., § 20.61).  
(Comment  173)  Some comments ask us to take action to ensure that third -party  
certification bodies act with maximum transparency and to ensure adequate protections against 
conflicts of interest.  Some comme nts ask that we post on our Web site information concerning 
the scope of the recognized accreditation body recognition and accredited certification body 
accreditation, duration of accreditation, payments made to those accreditation bodies and 
certification  bodies, and whether accreditation has been withdrawn or suspended.  Some 
comments assert that requiring recognized accreditation bodies and accredited certification 
bodies to make this information available on their own Web sites does not ensure that all 
potential conflicts of interest will be identified, and suggest that we require that this information 
be submitted directly to us as well.  231 
(Response  174)  FDA agrees that it would be helpful to include on our Web site 
information concerning the scope of ac creditation services that each recognized accreditation 
body is recognized for, and the scope of accreditation for each accredited certification body is 
accredited for.  We also agree it would be useful and increase transparency to include the 
duration of recognition for each accreditation body, and the duration of accreditation for each 
certification body.  Scope and duration information will make the site more practically useful 
and will increase transparency.  Therefore, we intend to include this informa tion on our Web site 
and we are revising § 1.690 to reflect this.  In addition, we are revising this section to state that 
FDA will post on its Web site a list of accreditation bodies for which it has denied renewal of 
recognition, for which FDA has revoked recognition, and that have relinquished t heir recognition 
or have allowed their recognition to expire.  Further, FDA will place on its Web site a list of 
certification bodies whose renewal of accreditation has been denied, for which FDA has 
withdrawn accreditation, and that have relinquished thei r accreditations or have allowed their 
accreditations to expire.  Finally, FDA will place on its Web site determinations under 
§ 1.670(a)(1) and modifications of such determinations under § 1.670(a)(2).  This additional 
information will help ensure maximum  transparency under the program.  
With regard to information on dates of payment, we have determined there is little 
additional value to posting such information on the FDA Web site, and it would create an 
additional administrative burden; we do not believe  the value exceeds the burden.  In our view, 
conflict of interest and transparency concerns are sufficiently satisfied by making information on 
dates of payment publicly available online via the Web sites of recognized accreditation bodies 
(see § 1.624(c))  and accredited certification bodies (see § 1.657(d)).  232 
(Comment  175)  Some comments request clarification concerning whether and what 
information we collect pursuant to this program will be made available to importers and the 
public.  Some comments questio n the extent and format of the audit data that will be shared, and 
what might be held confidential.  These comments assert that businesses have a need to protect 
proprietary information (e.g., sales lists, supplier lists, equipment designs and specific 
information about product attributes), and any sharing of such information might compromise 
their ability to carry out business functions or to maintain competitive advantage.  Some 
comments inquire about the extent and formats of audit data we intend to make  public, what 
might be held confidential, and whether we will take steps to protect information provided by 
certification bodies from FOIA requests.   
Some comments express concern about our ability to develop and maintain a dynamic 
system that will be abl e to collect, update, and present audit data to consumers, and assert that it 
is important for industry to gain a better understanding of what type of audit data we will require.   
Some comments suggest that we look to USDA’s Food Safety and Inspection Ser vice 
(FSIS ) Public Health Information System for insight into how to develop a database system that 
seeks to define the boundary between increasing public access to data and addressing 
confidentiality concerns by companies.  Some comments note that the FSI S program is the result 
of several years of effort to establish a mechanism for public access to data that can lead to 
research and analysis that improves public health while protecting the proprietary rights of the 
establishments.   
(Response  175)  As dis cussed previously, newly added § 1.695 clarifies that records 
under this subpart are subject to part 20; part 20 provides protections for trade secrets and 
confidential commercial information from public disclosure (see, e.g., § 20.61).   233 
FDA will provide periodic updates on program activities through our Web site, and our 
disclosures will be consistent with our statutory obligations to protect trade secrets and CCI from 
disclosure.  With regard to the expressed concern about FDA’s ability to develop and ma intain 
an adequate data system to collect, update, and present audit data to consumers, we are aware of 
the size and importance of this undertaking and are diligently pursuing an effective system.  We 
appreciate the suggestion to review the FSIS database s ystem and intend to do so.  
(Comment  176)  Some comments encourage us to develop communication strategies to 
help consumers view the data in audit reports within the context of food production; specifically, 
to set proper program expectations and to provide  proper context for consumers to understand 
what the data means.  These comments assert that it is important to provide a frame of reference 
so that consumers have a basis for understanding what the audit data means and can then proceed 
to make informed de cisions.  The comments note that audits and certifications are not 
declarations or guarantees that products are safe, and that FDA and the industry need to feature 
this reality in communications strategies aimed to assist consumer groups and consumers in 
using any audit data that might be available for review.  
(Response  176)  As noted above, we do intend to share updates on program activities 
with the public; we will work to properly contextualize the data in our communications about 
and presentation of the  information.  As noted in Response 173, FDA does not generally intend 
to make audit reports public.  
(Comment  177)  Some comments assert that we must clearly describe how compliance 
with the program will be reported to the public.  
(Response  177)  As noted above, we intend to provide periodic updates on program 
activities through our Web site.  Where appropriate, these updates may include aggregated 234 
program data.  Additional information about program updates will be shared as we implement 
this program.  Furt her, as noted in response to Comment 86, FDA will post information on its 
Web site  regarding accreditation bodies that have had their recognition revoked, accreditation 
bodies for which FDA fails to renew recognition, certification bodies that have had the ir 
accreditation withdrawn, and certification bodies whose renewal of accreditation has been 
denied.  
B.  How Do I Request Reconsideration of a Denial  by FDA of an Application  or a Waiver 
Request ? (§ 1.691)  
We proposed procedures for accreditation bodies and certification bodies to seek 
reconsideration of a denial of an application or a waiver request.  We also proposed that after 
completing our review and evaluation of the request for reconsideration, we will notify the 
requestor, in writing, of our decis ion to grant or deny the application or waiver request upon 
reconsideration.  
On our own initiative, we are revising § 1.691(c) to specify that a request for 
reconsideration or a waiver request must be submitted electronically.  We are making 
corresponding changes to § 1.692(b).  
(Comment  178)  Some comments suggest that we provide an opportunity for interested 
stakeholders , in addition to the accreditation body or third -party certification body seeking 
reconsideration, to  provide information to us that will inform our decisionmaking on any 
reconsideration request.   
(Response  178)  We decline to adopt comments’ suggestion  to allow for others beyond 
the accreditation body or third -party certification body seeking reconsideration to engage in this 
process.  Our  reconsideration  of a denial is not a public process nor do we wish to make it one.  235 
Applications often contain confidential information not appropriate for public comment.  We 
note that information shared with FDA is subject to the information disclosure regulations in part 
20, as stated in § 1.695.  
(Comment  179)  Some comments ask us to specify that we will notify the requestor of 
our decision within 20 business days after receiving a request for reconsideration.  These 
comments assert that the open -ended  timeframe for our review of reconsideration request may 
place an undue burden on the party seeking reconsideration.  
(Response  179)  FDA agrees that a request for reconsideration should be reviewed in a 
timely fashion.   FDA would anticipate that this revie w will generally be made within 30 business 
days.  However, given the conflicting demands on Agency resources at various times, the 
Agency declines to add this time restriction to § 1.691.  
C.  How Do I Request Internal Agency Review of a Denial  of an Appli cation  or Waiver Request 
Upon Reconsideration ? § 1.692  
We proposed that the requestor who received a denial upon reconsideration under § 1.691 
may seek internal Agency review of such denial under 21 CFR 10.75(c)(1).  
(Comment  180)  Some comments suggest tha t we provide an opportunity for interested 
stakeholders to provide information to us that will inform our decisionmaking on any such 
reconsideration request.   
(Response  180)  As with the parallel suggestion in the context of a request for 
reconsideration,  we decline to adopt comments’ suggestion.  The Agency’s review of a denial is 
not a public process nor do we wish to make it one.  As noted previously, applications often 
contain confidential information not appropriate for public comment.  We note that i nformation 236 
shared with FDA is subject to the information disclosure regulations in part 20, as stated in 
§ 1.695.  
D.  How Do I Request a Regulatory Hearing on a Revocation  of a Recognition  or Withdrawal  of 
Accreditation ? (§ 1.693)  
We proposed procedures th at would be used for challenges to revocation of recognition 
or withdrawal of accreditation.  
On our own initiative, we revised § 1.693(f) to include the standard for denial of a request 
for a regulatory hearing under 21 CFR 16.26(a).  
(Comment  181)  Some comments suggest that we provide an opportunity for interested 
stakeholders , in addition to the accreditation body or third -party certification body seeking a 
regulatory hearing, to provide information to us that will inform our decisionmaking during a 
regulatory hearing.   
(Response  181)  Again, we decline to adopt comments’ suggestion  to allow for others 
beyond the accreditation body or third -party certification body seeking to challenge an FDA 
decision to engage in this process .  For purposes of this fin al rule, we are not making the 
regulatory hearing a public process because issues pertaini ng to revocation and withdrawal  
generally contain confidential or sensitive information.  We note that information shared with 
FDA is subject to the information discl osure regulations in part 20, as stated in § 1.695.  We are 
amending proposed § 1.693(g)(3), redesignated as § 1.693(g)(2), to state that § 16.60(a) (public 
process) is inapplicable to hearings under this rule.  237 
E.  Are Electronic Records Created Under Thi s Subpart Subject to the Electronic Records 
Requirements of Part 11? (§ 1.694)  
We did not specify requirements for the retention of electronic records in the proposed 
rule.  However, as discussed in relation to § 1.625, we received several comments regard ing the 
potential application of the requirements for electronic records in part 11 to records under this 
subpart; several comments ask that we not apply the part 11 requirements here.  
We agree that it would be unnecessarily burdensome to requi re that rec ords under the 
third -party program comply with the requirements in part 11.  Therefore, we are adding §  1.694 
to the final rule which states that records that are established or maintained to satisfy the 
requirements of this subpart and that meet the defin ition of electronic records in § 11.3(b)(6) are 
exempt from the requirements of part 11.  We further specify that records that satisfy the 
requirements of this subpart, but those that also are required under other applicable statutory 
provisions or regulat ions, remain subject to part 11 to the extent that they are not separately 
exempted.  Consistent with these provisions, we are making a conforming change in part 11 to 
specify in §  11.1(m) that part 11 does not apply to records that meet the definition of electronic 
records in § 11.3(b)(6) required to be established or maintained under this subpart, and that 
records that satisfy the requirements of this subpart, but that also are required under other 
statutory provisions or regulations, remain subject to pa rt 11 to the extent that they are no t 
separately exempted.  
F.  Are the Records Required by This Subpart Subject to Public Disclosure ? (§ 1.695)  
In the proposed rule, we did not specify requirements regarding the public disclosure of 
records created and re tained under this subpart.  However, as discussed previously in the 
preamble , several comments express  concerns about whether notifications, records, and reports 238 
required by this rule would be protected from public disclosure.  The comments state  that 
notifications, records, and reports will often contain commercially sensitive i nformation.  Some 
comments ask  that the regulations specify that such information under this program have the 
same level of protection from public disclosure under FOIA as juice and  seafood HACCP 
records.  
Information submitted to the Agency, including reports and notifications submitted 
pursuant to §§  1.623 and 1.656, becomes an Agency record.  We note we have added a new 
§ 1.695 to the final rule to clarify that records under this subpart are subject to part 20; part 20 
provides protections for trade secrets and CCI from public disclosure (see, e.g., § 20.61).   
G.  May Importers Use Reports of Regulatory Audits By Accredited Certification Bodies for 
Purposes of Subpart L of This Part? (§ 1.698)  
We proposed that an importer as defined in § 1.500 of this part may use a regulatory audit 
of an eligible entity, documented in a regulatory audit report, in meeting the requirements for an 
onsite audit of a foreign supplier under subpart L of this part.  
(Comment  182)  Some comments agree with FDA’s proposal to allow importers to use 
regulatory audit reports of foreign suppliers, conducted for VQIP or import certification 
purposes, in meeting the verification requirements under the proposed F SVP program.   These 
comments state that  the use of regulatory audits by accredited third -party certification bodies 
should not be required under FSVP.   The comments assert that  importers should  be free to 
choose how best to  meet the verification requiremen ts.  Some comments misunderstood 
proposed § 1.698 to require the use of accredited third -party certification bodies for FSVP 
purposes.   239 
(Response  182)  To clarify that the use of an accredited third -party certification body for 
FSVP purposes is not requir ed by this rule, we are removing this provision.  This rule establishes 
the framework and procedures for participation in the accredited third -party certification 
program for purposes of sections 808 of the FD&C Act and does not create substantive 
requirem ents for the FSVP program .  However, regulatory audits may be used to meet supplier  
verification requirements  under FDA’s final preventive controls regulations and FSVP 
regulations if they comport with those requirements . 
XIV. Editorial and Conforming Chan ges 
The revised regulatory text includes several changes that we have made to clarify 
requirements and to improve readability.  The revised regulatory text also includes several 
conforming changes that we have made when a change to one provision affects ot her provisions.  
We summarize the principal editorial and conforming changes in table 5 .  We also made very 
minor editorial corrections, such as inserting a missing end parenthesis symbol; those changes 
are not included in this chart.  
Table 5.--Principal E ditorial and Conforming Changes  
Designation in the Revised 
Regulatory Text ( Section ) Revision  Explanation  
Throughout part 1, subpart M  Where applicable, s ubstitute d the term 
“assessment” , or its derivations,  for 
the term s “audit” or “review” , or their 
derivations,  when describing an FDA 
evaluation of an accreditation body 
and when describing an evaluation of 
a third -party certification body 
performed by a recognized 
accreditation body or by FDA . Conforming change  
Throughout part 1, subpart M  Where appl icable, s ubstitute d 
“evaluate” , or its derivations,  for 
“assess” or “determine” , or their 
derivations,  when describing the 
nature of activities involved in an 
“assessment” (as defined in this rule) 
of an accreditation body or a third -
party certification bo dy. Conforming change  240 
Designation in the Revised 
Regulatory Text ( Section ) Revision  Explanation  
Throughout part 1, subpart M  Where applicable, s ubstitute d 
“examine” , or its derivations,  for 
“audit”, “assess”, “determine”, or 
“evaluate” , or their derivations,  when 
describing the nature of activities 
involved in an “audit,” as defined in 
this rule, of an eligible entity . Conforming change  
Throughout part 1, subpart M  Where applicable, revised to refer to 
“audit agent” rather than “agent”  when 
describing individuals who conduct 
audits for accredited third -party 
certification bodies.  Use “agent(s) 
used to conduct audits” rather than, 
“audit agent(s)”  when referring to 
individuals who conduct audits for a 
third -party certification body prior to 
its accreditation under this program.  Improve clarity  
Throughout part 1, subpart M  Revised to r efer to “competency” 
rather than “competence”  Improve clarity  
Throughout part 1, subpart M  Where appropriate, revised to refer to 
“recognized accredit ation bodies” 
rather than “accreditation bodies”  Improve clarity  
Throughout part 1, subpart M  Where appropriate, revised to refer to 
“accredited third -party certification 
bodies” rather than “third -party 
certification bodies”  Improve clarity  
Throughout part 1, subpart M  Where appropriate, rephrased “[i]f 
FDA has reason to believe that a food 
certification issued for purposes of 
section 801(q) of the FD&C Act is not 
valid or reliable, FDA may refuse to 
consider the certification in 
determining the admissi bility of the 
article of food for which the 
certification was offered.”  Improve clarity  
Throughout part 1, subpart M  Replaced “personnel” with 
“employees”  Improve clarity  
§ 1.600 (c) Deleted “, including the model 
accreditation standards” from the 
definition of “accreditation”  Conforming change  
§ 1.600 (c) Revised the definition of “accredited 
third party certification body”  to 
replace “is authorized” with “is 
accredited”  Improve clarity  
§ 1.600(c)  Revised the definition of “eligible 
entity” to rep lace “subject to the 
registration requirements of” with 
“required to be registered under”  Improve clarity  
§ 1.600(c)  Revised the definition of “facility 
certification” to replace “establish that 
a facility meets” with “establish 
whether a facility complies with”  Improve clarity  241 
Designation in the Revised 
Regulatory Text ( Section ) Revision  Explanation  
§ 1.600 (c) Revised the definition of “food 
certification” to replace “establish that 
a food meets” with “establish whether 
a food of an eligible entity complies 
with”  Improve clarity  
§ 1.600 (c)  Revised the definition of 
“relinquishment” to state that 
relinquishment occurs prior to the 
expiration of recognition or 
accreditation for accreditation bodies 
and certification bodies, respectively.  Improve clarity  
§ 1.601(a)  Changed “for conducting food safety 
audits and for issu ing food and facility 
certifications to eligible entities” to “to 
conduct food safety audits and to issue 
food and facility certifications”  Improve clarity  
§ 1.601(b)(2)  Changed “Issuing food and facility 
certifications” to “Issuing 
certifications”  
 
Changed “or in meeting the eligibility 
requirements” to “or issuing a facility 
certification for meeting the eligibility 
requirements”.  Improve clarity  
§ 1.601(c)  Replaced “except as provided in 
paragraph (d) of this section” with 
“under this subpart”  Correction  
§ 1.601(d)  Redesignated paragraphs (1), (1)(i), 
(1)(ii), (2), (2)(i), and (2)(ii) as 
paragraphs (1)(i), (1)(i)(A), (1)(i)(B), 
(1)(ii), (1)(ii)(A), and (1)(ii)(B ). Editorial change  
§ 1.601(d)(1)(i)  Changed “[t]he certification of food 
under section 801(q)” to “[a]ny 
certification required under section 
801(q)”  Conforming change  
§ 1.601(d)(1)(ii)  Changed “[c]ertification of food under 
section 801(q)” to “Any certification 
required under section 801(q)”  Conforming change  
§ 1.601(d)(1)(ii)  Changed “food other than alcoholic 
beverages that is from a facility” to 
“food that is not an alcoholic beverage 
that is received and distributed by a 
facility ”. Improve clarity  
§ 1.610  Section heading changed from “[w]ho 
is eligible for recognition,” to “[w]ho 
is eligible to seek recognition;”  
 
Text changed from “eligible for 
recognition” to “eligible to seek 
recognition”  Improve clarity  242 
Designation in the Revised 
Regulatory Text ( Section ) Revision  Explanation  
§ 1.611(a)  Changed “through” to “as a legal 
entity with”  
 
Removed “such” from between 
“perform” and “assessments”  
 
Changed “its capability to audit” to 
“its capability to conduct audits”  Improve clarity  
§ 1.611(a)(2)  Replaced “personnel and other 
agents,” with “its agents, (or the third -
party certification body in the case of a 
third -party certification body that is an 
individual, such individual)”  Conforming change  
§§  1.611(b ), 1.612(b ), 1.613(b ), 
1.614(b ), 1.615(b ), 1.623(d)(2 ), 
1.630(b ), 1.631(b ), 1.641(b ), 
1.642(b ), and 1.645(b)  In sentences referencing requirements 
for recognized accreditation bodies or 
accredited third -party certification 
bodies, replaced specific references to 
other sections of this rule with “the 
applicable […] requirements of this 
subpart”  Improve clarity  
§ 1.612(b)  Changed “capability to meet the…” to 
“capability to meet the applicable”  Clarif y that only the applicable 
assessment and monitoring 
requirements apply.  
§ 1.615(a)  Added “pertaining to this subpart” 
between “legal obligations” and “and 
to provide”  Improve clarity  
§ 1.615(b)  Replaced “[i]s capable of meeting,” 
with “The capability to meet”  Editorial change  
§ 1.620(a)(2)  Removed “that aggregates the 
products of growers or processor 
[sic],” after “foreign cooperative”  Conforming change  
§ 1.620(d)  Replace d “including,” with, “and 
include”  Editorial change  
§ 1.621  Last word of section heading changed 
from “accredits” to “accredited”  Editorial change  
§ 1.621(a)  At the end of the previously 
undesignated paragraph which is now 
paragraph (a), moved “recognized 
accreditation body . . . with this 
subpart” . Improve clarity  
§ 1.622(a)  Added “compliance with this subpart, 
including” at the end of the opening 
phrase . Improve clarity  
§ 1.622(a)(1)  Replaced “or other agents in activities 
under this subpart and the degree of 
consistency among such 
performances,” with “or other agents 
involved in accreditation activities and 
the degree of consistency in 
conducting accreditation activities”  To clarify that the relevant activities 
under this subpart are accreditation 
activities.  243 
Designation in the Revised 
Regulatory Text ( Section ) Revision  Explanation  
§ 1.622(a)(2)  Added “involved in accreditation 
activities,” between “other agents,” 
and “with the conflict of interest 
requirements”  Conforming change  
§ 1.622(c)(1)  Change d “area(s) needing 
improvement,” to “area(s) where 
deficiencies exist”  Improve clarity  
§ 1.622(c)(2)  Change d “implement effective 
correction ac tion(s) to address those 
area(s)” to “implement corrective 
action(s) that effectively address those 
deficiencies”  Improve clarity  
§ 1.622(c)(3)  Insert ed “any” between “records of,” 
and “such corrective action(s)”  Improve clarity  
§ 1.622(d)  Changed “includes:” to “includes the 
following elements.”  Conforming change  
§ 1.622(d)(2)  Added “involved in accreditation 
activities,” between, “other agents,” 
and “complied with the conflict of 
interest requirements”  Conforming change  
§ 1.623(b)  Created subpar agraphs by inserting, 
“(i)” before “a report of the results of 
an annual self -assessment” and “(ii)” 
before “for a recognized accreditation 
body subject to § 1.664(g)((1);”  
 
Removed “must submit” from 
between “§1.664(g)(1),” and “a report 
of such self -assessment;”  
 
Changed “to FDA within 2 months” to 
“to FDA within 60 days of the third 
party certification body’s withdrawal.”  Improve clarity  
§ 1.623(c)(1)  Added “(including expanding the 
scope of),” between “[g]ranting,” and 
“accreditation”  Improve clarity  
§ 1.623(d)(1)(iv)  Added “scope and,” between “the” 
and “basis for such denial”  Improve clarity  
§ 1.624(a)  Changed from “other agents)” to 
“other agents involved in accreditation 
activities)”  Conforming change  
§ 1.624(b) redesignated as 
§ 1.624(c)  Rephrased “ [t]he financial interests of 
the spouses and children younger than 
18 years of age of officers, personnel, 
and other agents of a recognized 
accreditation body will be considered 
the financial interests of such officers, 
personnel, and other agen ts of the 
accreditation body”  Improve clarity  
§ 1.624(d)  Changed “and date(s) on each the 
accredited” to “and the date(s) on 
which the accredited”  Editorial change  244 
Designation in the Revised 
Regulatory Text ( Section ) Revision  Explanation  
§ 1.625 title and paragraphs (a), 
(b), and (c) Changed from “A recognized 
accreditation body,” to “An 
accreditation body that has been 
recognized”  To clarify that the duties with 
respect to records as required under 
this subpart adhere to any 
accreditation body that has been 
recognized, including accreditation 
bodies that are no longer recogn ized.  
§ 1.625(a)(2)  Added “expand or” after “withdraw, 
or” Improve clarity  
§ 1.630(c)  Changed from “needed by FDA to 
process the application” to “needed by 
FDA during processing of the 
application”  Improve clarity  
§ 1.630(d)  Changed from “signed by the 
applicant or by any individual 
authorized” to “signed by an 
individual authorized”  Improve clarity  
§ 1.631 heading  Changed heading from “How will 
FDA review applications for 
recognition and renewal of 
recognition?” to “How wil l FDA 
review my application for recognition 
or renewal of recognition and what 
happens once FDA decides on my 
application?”  Improve clarity  
§ 1.631(a)  Added “an accreditation body’s” after 
FDA will review, deleted “a”  Improve clarity  
§ 1.631(b)  Inserted “regarding” before “whether 
the application has been approved or 
denied.”  Editorial change  
§ 1.631(c)  Changed to state that the FDA will 
notify an applicant that its recognition 
or renewal application has been 
approved through issuance of 
recognition that  will list any 
limitations associated with the 
recognition.  Improve clarity  
§ 1.631(d)  Changed to state that the FDA will 
notify an applicant that its recognition 
or renewal application has been denied 
through issuance of a denial of 
recognition that will  state the basis for 
such denial and provide the procedures 
for requesting reconsideration of the 
application under § 1.691.  Improve clarity  
§ 1.632  Added “from the date of recognition” 
to the end of the sentence . Improve clarity  
§ 1.633(a)  Removed “periodically”  Improve clarity  
§ 1.633(a)  Rephrased “date of accreditation for a 
5-year term of recognition, or by no 
later than mid -term point for 
recognition granted for less than 5 
years.”  Improve clarity  245 
Designation in the Revised 
Regulatory Text ( Section ) Revision  Explanation  
§ 1.633(b)  Rephrased “These may be conducted 
at any time, with or without the 
accreditation body or 
auditor/certification body present”  Improve clarity  
§ 1.634(a)  Inserted “found not to be in 
compliance with the requirements of 
this subpart, including” after “of an  
accreditation body”  Improve clarity  
§ 1.634(a)(2)(ii)  Changed “problem with the 
accreditation body” to “deficiency”  Improve clarity  
§ 1.634(a)(2)(iii)  Inserted “to do so” after “[d]irected”  Improve clarity  
§ 1.634(c)(1)  Changed “Upon revocation, FDA will 
notify that accreditation body, 
electronically, in English, stating…”  Improve clarity  
§ 1.634(d)(1)  Removed “electronically and in 
English”  Improve clarity  
§ 1.634(d)(1)(i)  Rephrased from “[n]o later than 2 
months after the revocation” to “[n]o 
later than 60 days after the date of 
issuance of the revocation”  Improve clarity  
§ 1.634(d)(1)(ii)  Added “or the original date of the 
expiration of the accreditation, 
whichever comes first” after 
“revocation”  
 
Changed from “ a recognized” to, 
“another recognized”  Improve clarity  
§ 1.634(d)(2)  Added “(c)” after “1.664”  Improve clarity  
§ 1.635 heading  Changed heading from “How do I 
voluntarily relinquish recognition?” to 
“What if I want to voluntarily 
relinquish recognition or  do not want 
to renew recognition?”  Improve clarity  
§ 1.636(a)  Removed “or may be required to 
submit such application after a 
determination in a regulatory hearing 
under § 1.693”  Improve clarity  
§ 1.640 heading  Changed heading from, “Who is 
eligible for accreditation?” to, “Who is 
eligible to seek accreditation?”  Improve clarity  
§ 1.641(a)  Changed “or through contractual 
rights” to “or as a legal entity with 
contractual rights” and added “and 
conformance with applicable” before 
“industry standards and pr actices”  Conforming change  
§ 1.642(a)(1)  Changed “industry standards and 
practices and to issue” to 
“conformance with applicable industry 
standards and practices and issuance 
of”  Improve clarity  246 
Designation in the Revised 
Regulatory Text ( Section ) Revision  Explanation  
§ 1.641(a)(2)  Changed “of the eligible entity” to “of 
an eligible  entity”  
 
Removed “such as witnessing the 
performance of a statistically 
significant number of personnel and 
other agents conducting audits of food 
facilities”  Conforming change  
§ 1.643(a)  Replaced “certification body (and its 
officers, personnel, and other agents) 
and eligible entities (and their owners 
and operators) seeking assessment and 
certification from,”  Improve clarity  
§ 1.644(a)(1)  Rephrased “[i]dentify areas in its 
auditing and certification program or 
performance that need improvement” 
to “[i]dentify deficiencies in its 
auditing and certification program or 
performance”  Improve clarity  
§ 1.644(a)(2)  Rephrase d from “Quickly execute 
corrective actions when problems are 
found” to “[q]uickly execute 
corrective actions that effectively 
address any identified deficiencies”  Improve clarity  
§ 1.650 heading  Changed heading from “How must an 
accredited auditor/third -party 
certification body ensure its audit 
agents are competent and objective”, 
to “How must an accredited third -
party certification body ensure 
competency and objectivity?”  Improve clarity  
§ 1.650(a)(3)  Changed from “[p]articipates in 
annual food safety under the 
accredited auditor’s/certification 
body’s training plan,” to “[c]ompletes 
annual food safety training that is 
relevant to activities conducted under 
this subpart”  Improve clarity  
Throughout § § 1.651 and 1.652  Where appropriate, added “eligible” 
before “entity” and “food safety” 
before “audit”  Improve clarity  
§ 1.651(a)(1)(i)  Inserted “subject to the requirements 
of this subpart” after “be conducted as 
a consultative or regulatory audit”  Improve clarity  
§ 1.651(b)(1)  Changed from “[c]onduct an 
unannounced audit to verify whether 
the activities and results” to “[c]onduct 
an unannounced audit to determine 
whether the facility, process(es), and 
food”  Conforming change.  
§ 1.651(b)(2)  Removed “and, where appropriate, to 
issue food and facility certifications” 
from end of phrase  Improve clarity  247 
Designation in the Revised 
Regulatory Text ( Section ) Revision  Explanation  
§ 1.651(b)(5)  Insert ed “audits conducted under this 
subpart as follows” after “[p]repare 
reports of”  Improve clarity  
§ 1.651(b)(5)(i) (previously §  
1.651(b)(5))  Inserted “For” before “consultative 
audits,”  
 
Inserted “maintain such records, 
subject to FDA access in accordance 
with section 414 of the FD&C Act”  Improve clarity  
§ 1.651(b)(5)  Created (i) and (ii) to more easily 
distinguish between the different 
requirements for consultative and 
regulatory audits . Improve clarity  
§ 1.651(b)(6)  Inserted “under this subpa rt” after 
“food safety audit”  Improve clarity  
§ 1.651(c)(2)  Changed “to establish compliance 
with the FD&C Act” to “to determine 
compliance with the applicable food 
safety requirements of the FD&C Act 
and FDA regulations, and, for 
consultative audits, also includes 
conformance with applicable industry 
standards and practices”  Improve clarity  
§ 1.651(c)(3)  Rephrased “entity would be likely to 
remain in compliance with the 
applicable requirements of the FD&C 
Act for at least 12 months following 
the audit , provided that the facility and 
its process(es) are properly maintained 
and implemented.”  Improve clarity  
§ 1.651(c)(4)  Removed “assessment” and added 
“other data and information from the 
examination, including information 
on” 
 
Removed “of the accredited 
auditor/certification body”  Improve clarity  
Throughout § § 1.652, 1.653  Where appropriate, inserted, 
“regulatory” before, “audit”  Improve clarity  
§ 1.652(a)  Reformatted requirements in 
§ 1.652(a)(1) through  (6) to more 
closely align with formatting of 
§ 1.652(b)(1) through (6);  
 
Inserted “subject to FDA access in 
accordance with the requirements of 
section 414 of the FD&C Act”  Editorial change  
 
 
 
 
Improve clarity  
§ 1.652(b)(1)  Replaced “audited facility” with “site 
or location where the regulatory audit 
was conducted”  Improve clarity  
§ 1.652(b)(6)(i) and (ii)  Inserted “to humans or animals” after 
“serious adverse health consequences 
or death”  Improve clarity  248 
Designation in the Revised 
Regulatory Text ( Section ) Revision  Explanation  
§ 1.652(b)(8)  Rephrased from “is used in the 
facility” to “is performed in or used by 
the facility”  Improve clarity  
§ 1.653 heading  Changed heading from “What must 
accredited auditor/certification body 
do when issuing food or facility 
certifications?” to “What must  an 
accredited third -party certification 
body do when issuing food or facility 
certifications?”  Improve clarity  
§ 1.653(a)(1)  Changed “(or an audit agent” to “(or, 
where applicable, an audit agent”  
 
Changed “to establish compliance” to 
“to determine compliance”  Improve clarity  
§ 1.653(a)(2)  Changed “an observation” to “a 
deficiency”  Improve clarity  
§ 1.654  heading  Rephrased language in head ing from 
“eligible entity with a food or facility 
certification” to “eligible entity that it 
has issued a food or facility 
certification”  Improve clarity  
§ 1.654  Added “with such requirements” after 
“compliance”  
 
Changed “if it determines the eligible 
entity is no longer” to “if it withdraws 
or suspends a food or facility 
certification because it determines that 
the entity is no longer”  Improve clarity  
§ 1.655(a)  Changed “must an nually, and as 
required under § 1.631(f)(1)(i) or upon 
FDA request made for cause, conduct 
a self -assessment that includes 
evaluation of:”  Improve clarity  
§§ 1.655(a)(1), 1.655(a)(2), 
1.655(a)(3), 1.655(d)(2), 
1.657(a), 1.657(a)(1), 1.657(c)  Added “involved in auditing and 
certification activities,” after “other 
agents”  Improve clarity  
§§ 1.655(a)(1), 1.655(a)(2)  Removed “under this subpart”  Improve clarity  
§ 1.655( a)(5) Inserted “of” between “determination” 
and “whether”  Editorial change  
§ 1.655(c)(1)  Replaced “area(s) needing 
improvement” with, “deficiencies in 
complying with the requirements of 
this subpart”  Improve clarity  
§ 1.655(c)(2)  Rephrased from “effective corrective 
action(s) to address those area(s)” to 
“corrective action(s) that  effectively 
address the identified deficiencies”  Improve clarity  
§ 1.656(b)  Modified submission timeframe from 
2 months to 60 days  Conforming change  249 
Designation in the Revised 
Regulatory Text ( Section ) Revision  Explanation  
§ 1.656(c)  Rephrased “when any of its audit 
agents or the accredited auditor/third -
party certification body itself, 
discovers any condition found during a 
regulatory or consultative audit of an 
eligible entity, which”  Improve clarity  
§ 1.657(a)(3) redesignated as 
§ 1.657(a)(4)  Added “accredited third -party 
certification body’s” after 
“[p]rohibiting an”  
 
Changed “other agent of the accredited 
auditor/certification body from 
accepting any money, gift, gratuity, or 
item of value” to “other agent 
involving in auditing a nd certification 
activities from accepting any money, 
gift, gratuity, or other item of value”  Improve clarity  
§ 1.657(a)(4) redesignated as 
§ 1.657(a)(5)  Changed reference from “(a)(3)” to 
“(a)(4)”  Editorial change  
§ 1.657(a)(4)(i) redesignated as  
§ 1.657(a)(5)(i)   Changed from “accreditation” to, 
“auditing and certification”  Correction  
§ 1.657( c) Added “accredited third -party 
certification body’s” before “officers”  
 
Changed “other agent s of an 
accredited auditor/certification body” 
to “other agents involving in auditing 
and certification activities”  Improve clarity  
§ 1.658 heading  Changed heading to “What records 
requirements must an accredited 
auditor/certification body that has 
been accredited meet?”  Improve clarity  
§ 1.658(a)  Rephra sed from “certification body 
must maintain electronically for 4 
years records” to “certification body 
that has been accredited must maintain 
electronically for 4 years records 
created during its period of 
accreditation”  Improve clarity  
§ 1.658(a)(1)  Removed “laboratory testing records 
and results (as applicable)  Conforming change  
§§ 1.658(a)(1), 1.658(a)(3)  Rephrased from “and corrective 
actions” to “verification of any 
corrective action(s) taken”  Improve clarity  
§ 1.658(a)(4)  Replaced “under § 1.65 0(a)(5) or by 
the accredited auditor/certification 
body to FDA under § 1.656(e)” with 
“in accordance with § 1.650(a)(5)”  Conforming change  
§ 1.658(a)(5) -(a)(9) redesignated 
as § 1.658(a)(5) -(a)(8)  Removed paragraph (a)(5 ). Conforming change  
§ 1.658(a)(8)  redesignated as 
§ 1.658(a)(7)  Rephrased from, “taken as a result” to 
“taken to address any deficiencies 
identified during a self -assessment”  Improve clarity  250 
Designation in the Revised 
Regulatory Text ( Section ) Revision  Explanation  
§ 1.658(a)(9) redesignated as 
§ 1.658(a)(8)  Changed “the auditing or certification 
program” to “its auditing or 
certification program”  Improve clarity  
§ 1.658(b)  Changed from “FDA in accordance 
with the requirements of subpart J of 
this chapter” to “FDA in accordance 
with section 414 of the FD&C Act”  Correction  
§ 1.660 heading  Changed heading to “ Where do I 
apply for accreditation or renewal of 
accreditation by a recognized 
accreditation body and what happens 
once the recognized accreditation 
body decides on my application?”  Improve clarity  
§ 1.661  Added “by a recognized accreditation 
body” at end  of header . Improve clarity  
§ 1.662(a)  Rephrased “comply with the 
requirements of §§ 1.640 to 1.658 and 
whether there are deficiencies in the 
performance of the accredited 
auditor/certification body that, if not 
corrected, would warrant withdrawal 
of its accreditation under this subpart.”  Improve clarity  
§ 1.662(b)(4)  Rephrased from “regarding the 
accredited auditor’s/certification 
body’s authority, qualifications 
(including the expertise and training of 
its audit agents), conflict of interest 
program, i nternal quality assurance 
program, and monitoring by its 
accreditation body (or, in the case of 
direct accreditation, FDA);”  Improve clarity  
§ 1.663(d)  Rephrased from “submission was 
completed” to “completed submission 
is received”  Improve clarity  
§ 1.663(e)  Removed “in writing” and “Such 
notification may be made 
electronically.”  Conforming change  
§ 1.663(f)  Replaced “conditions” with 
“limitations”  Improve clarity  
§ 1.663(f)  Replaced “notification” with “issuance 
of the waiver” and “issuance of a 
denial of a waiver request” as 
appropriate.  
 
Replaced “conditions” with 
“limitations”  Improve clarity  
§ 1.664(a)(1)  Added “or chemical or physical 
hazard”  Correction  
§ 1.664(a)(2)  Changed “meets the requirements” to 
“complies with the applicable 
requirem ents”  Improve clarity  251 
Designation in the Revised 
Regulatory Text ( Section ) Revision  Explanation  
§ 1.664(b)(2)  Replaced “steps” with “relevant audit 
records”  
 
Replaced “to justify the food or 
facility certification” with “in support 
of its decision to certify”  Improve clarity  
§ 1.664(c)(2)  Delete d “food or facility”  For flexibility  
§ 1.664(e)(1)  Added “of its accreditation through 
issuance of a withdrawal that will 
state”  Improve clarity  
§ 1.664(e)(1)  Deleted , “electronically, in English”  Conforming change.  
§ 1.664(e)(2)  Added “issuance of the” between 
“date of” and withdrawal”  Improve clarity  
 
§ 1.664(g)(1)  Replaced “bodies” with “body it 
accredited ” 
 
Added “by FDA.”  
 
Changed “2 months” to “60 days.”  
 
Removed “electronically and in 
English”  Improve clarity  
§ 1.664(g)(2)  Replaced “such” with “an”  Editorial change  
§ 1.664(h)  Replaced “and the status of 
recognition and food and facility 
certifications” in the heading with 
“accreditation”  Improve clarity  
§ 1.664(h)  Replaced “under this subpart” with 
“and provide a description of the basis 
for withdrawal”  Improve clari ty 
§ 1.665 heading  Changed heading from “How do I 
voluntarily relinquish accreditation? to 
“what if I want to voluntarily 
relinquish accreditation or do not want 
to renew?”  Improve clarity  
§ 1.665(a)  Changed “2 months” to “60 days”  Improve clarity  
§ 1.665(b)  Added “The accreditation body must 
establish and maintain records of such 
notification under § 1.625(a).”  Clarification  
§ 1.666(a)(1)  Replaced “ requirements for 
accreditation” with “applicable 
requirements of this subpart”  Improve clarity  
§ 1.6 66(a)(2)(i)  Replaced “a” with “another” and “not” 
with “no”  Editorial changes  
§ 1.670(a)(3)  Added “(a)(1) of this section, as 
described in paragraph (a)(2)”  Correction  252 
Designation in the Revised 
Regulatory Text ( Section ) Revision  Explanation  
§ 1.670(b)(1)  Revised to s pecif y provision “(a)(1)”  Improve clarity  
§ 1.670(b)(2)  Added subsection title “ Submission ” Improve clarity  
§ 1.670(b)(3)  Added subsection title “ Signature ” Improve clarity  
§ 1.671 heading  Changed title from “How will FDA 
review applications for direct 
accreditation and for renewal of direct 
accreditation?” to “How will FDA 
review my application for direct 
accreditation or for renewal of direct 
accreditation and what happens once 
FDA decides on my application?”  Improve clarity  
§ 1.671(b)  Reorganized the provision:   Moved 
original (f) under (b)  Improve clarit y 
§ 1.671(c) previously (c) and (d)  Redesignated as (c) to state that FDA 
will notify an applicant that its direct 
accreditation or renewal application 
has been approved through issuance of 
direct accreditation that will list any 
limitations associated with the 
accreditation.  Improve clarity  
§ 1.671(e)  Redesignated (e) to (d)  
 
Replaced “denies” with “issues a 
denial ” 
 
Added “for direct accreditation or for 
renewal of direct accreditation”  
 
Replaced “notification” with “issuance 
of the denial of direct a ccreditation”  
 
Deleted “address and”  Improve clarity  
§ 1.681  Combined (a) and (b)  
 
Replaced “seek” with “apply for”  Improve clarity  
§ 1.691(a) and (b)  Replaced “decision” with “the 
issuance of such denial”  Improve clarity  
§ 1.691(c)  Replaced “it describes” with 
“described in the notice”  Editorial change  
§ 1.691(d)  Deleted “in writing”  
 
Rephrased “of its decision to grant the 
application or waiver request upon 
reconsideration, or its decision to deny 
the application or waiver request upon 
reconsideration”  Improve clarity  253 
Designation in the Revised 
Regulatory Text ( Section ) Revision  Explanation  
§ 1.692(a)  Replaced “FDA issued” to “of 
issuance of”  Editorial cha nge 
§ 1.692(d)  Deleted “electronically”  
 
Added phrases “ through issuance of 
an application or waiver request upon 
reconsideration” and “application or 
waiver request upon reconsideration 
through issuance of a denial of”  Improve clarity  
§ 1.692(e)  Replaced “Affirmation” with 
“Issuance”  Improve clarity  
§ 1.693  Replaced “FDA issued” and “written 
notice” with “issuance of”  For consistency and to improve 
clarity  
§ 1.693(a)  Rephrased “the accreditation body or 
an individual authorized to act on its 
behalf” to “an individual authorized to 
act on the accreditation body’s behalf”  Improve clarity  
§ 1.693(b)  Rephrased “the auditor/certification 
body or an individual authorized to act 
on its behalf” to “an individual 
authorized to act on the third -party 
certification body’s behalf”  Improve clarity  
 
XV.  Executive Order 13175  
In accordance with Executive Order 13175, FDA has consulted with tribal government 
officials. A Tribal Summary Impact Statement has been prepared that includes a summary of 
Tribal off icials' concerns and how FDA has addressed them (Ref. 26). Persons with access to the 
Internet may obtain the Tribal Summary Impact Statement at http://www.regulations.gov . Copies 
of the Tribal Summary Impact Statement also may be obtained by contacting th e person listed 
under FOR FURTHER INFORMATION CONTACT.  
XVI.  Analysis of Economic Impact  
FDA has examined the impacts of the final rule under Executive Order 12866, Executive 
Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601 -612), and the Unfunded Mandates 
Reform Act of 1995 (Pub . L. 104-4).  Executive Orders 12866 and 13563 direct Agencies to 254 
assess all costs and benefits of available regulatory alternatives and, when regulation is 
necessary, to select regulatory approaches that maximize net benefi ts (including potential 
economic, environmental, public health and safety, and other advantages; distributive impacts; 
and equity).  The Agency believes that this final rule is a significant regulatory action under 
Executive Order 12866.  
The Regulatory Fle xibility Act requires Agencies to analyze regulatory options that 
would minimize any significant impact of a rule on small entities.  Because the Third -Party 
program will be used primarily on voluntary basis where private enterprises determine that the 
benefits of participating in our program outweighs their associated user fee and compliance 
costs, the Agency certifies that the final rule will not have a significant economic impact on a 
substantial number of small entities.  
Section 202(a) of the Unfunded M andates Reform Act of 1995 requires that Agencies 
prepare a written statement, which includes an assessment of anticipated costs and benefits, 
before proposing "any rule that includes any Federal mandate that may result in the expenditure 
by State, local, and tribal governments, in the aggregate, or by the private sector, of 
$100,000,000 or more (adjusted annually for inflation) in any one year."  The current threshold 
after adjustment for inflation is $14 4 million, using the most current (2014)  Implicit Pr ice 
Deflator for the Gross Domestic Product.  FDA does not expect this final rule to result in any 1 -
year expenditure that would meet or exceed this amount.   Annualized cost of the Third -Party 
final rule is estimated at approximately $2. 8 to $11.6 million , depending on the scenario . 
XVII.  Paperwork Reduction Act of 1995  
This final rule contains information collection provisions that are subject to review by 
OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 -3520).  The title, description, 255 
and re spondent description of the information collection provisions are shown in the following 
paragraphs with an estimate of the annual reporting and recordkeeping burdens.  Included in the 
estimate is the time for reviewing instructions, searching existing dat a sources, gathering and 
maintaining the data needed, and completing and reviewing each collection of information.  
 Title :  Accreditation of Third -Party Certification Bodies to Conduct Food Safety 
Audits and Issue Certifications (Third -Party final rule)  
 Description :  FDA is amending its regulations to provide for accreditation of 
third -party certification bodies (CBs) to conduct food safety audits of eligible foreign food 
entities, including foreign food facilities, and to issue food and facility certifica tions, pursuant to 
the FDA Food Safety Modernization Act.  Use of accredited third -party CBs and food and 
facility certifications will help us prevent potentially harmful food from reaching U.S. consumers 
and thereby improve the safety of the U.S. food sup ply.  We also expect that these regulations 
will increase efficiency by reducing the number of redundant audits to assess compliance with 
applicable food safety requirements of the FD &C Act and FDA regulations.  
Description of respondents :  The coverage of the Third -Party final rule includes eligible 
entities seeking audits, certification, and/or recertification by accredited CBs participating in our 
program, accreditation bodies (ABs) seeking to comply with the recognition requirements of the 
Third -Party final rule, and CBs seeking to comply with the accreditation requirements of the 
Third -Party final rule (including those accredited by recognized ABs and those directly -
accredited by FDA).  An eligible entity is a foreign entity in the import supply chain of  food for 
consumption in the United States that chooses to be subject to a food safety audit conducted by 
an accredited third -party certification body . 256 
 Based on FDA Operational and Administration System for Import Support  
database information, we estimate  that there are 200,692 foreign food and feed exporters that 
offer their food and feed for import into the U nited States.  These foreign food and feed exporters 
include 129,757 food and feed production facilities and 70,935 farms.  A proportion of these 
foreign food and feed exporters may offer food subject to mandatory certification requirements 
under section  801(q) of the FD&C Act.  In that case, the eligible entities must either comply with 
the Third -Party final rule in order to o btain certification from a CB accredited under the third -
party program to continue exporting their food products into the U nited States, or a foreign 
government designated by FDA, or lose their access to U.S. markets.   In the economic analysis 
of the Third -Party final rule, we assume that in any given year 75 foreign food and feed exporters 
will be subject to section  801(q) of the FD&C Act.   
In addition to the entities subject to § 80 1(q), some food exporters will seek certificates 
to participate in VQIP u nder section  806 of the FD&C Act.  We consider three different 
scenarios for the participation rate of VQIP importers and their associated foreign suppliers in 
a 10-year period:  (1) Constant number of VQIP importers in every year, (2) increasing 
participa tion over time, peaking at 20  percent of all importers of perishable products by the 
fifth year, with stagnant growth in subsequent years, (3) increasing participation over time, 
peaking at 40  percent  of all importers of perishable products by the 10th yea r of the program.  
The VQIP draft guidance document caps the acceptance of applications by importers 
for VQIP at 200 for the initial year of the program.   Under Scenario 1, we consider 200 
importers participating in each of first 10 years of VQIP (see table 6). Average number of 
foreign suppliers per importers is approximately 5.58; therefore, under Scenario 1, we expect 
that 200 importers and approximately 1,116 foreign suppliers (200 importers × 5.58 foreign 257 
supplier per importer) will be participating in  VQIP every year for a 10-year period (see 
tables 6 and 7). 
According to FDA’s Office of Regulatory Affairs Reporting Analysis and Decision 
Support System  database, the number of importers of perishable products is approximately 
2,759.  These importers wou ld have an incentive to participate in VQIP in order to expedite 
entry of their perishable food products into the U nited States .  Under Scenario 2, we consider 
200 importers participating in the initial year of VQIP and increasing steadily until the fifth 
year of the program until 552 importers (20  percent  × 2,759 importers of perishable products) 
are participating in the program.  For years 6 through 10, we consider 3  percent  increase in 
participation of new importers in VQIP (see table 6). Multiplying the number of importers by 
the number of foreign suppliers per importers (5.58), we expect that the number of foreign 
supplies parti cipating in VQIP, under Scenario 2, would increase from 1,116 to 3,527 in a 10 -
year period (see table 7). 
Under Scenario 3, we consider the number of importers will increase from 200 in the 
initial year of VQIP to 1,104 importers (40  percent  × 2,759 import ers of perishable products) 
in the 10th year of the program.  Tables 6 and 7 include the number of importers and their 
associated foreign suppliers for scenario 3.  Table 9 includes total number of eligible entities 
in the Third -Party final rule based on t he three considered scenarios in the 10th year of the 
program.  
The economic  analysis of the Third-Party final rule estimates compli ance costs und er 
the assumption th at expected efficiency gains, and foreign food suppliers’ incentive to maintain 
continued importation of their food  to the  United States would l ead all foreign suppli ers subj ect 
to section  801(q) of the FD&C Act, and foreign suppli ers who choose  to use third-party food 258 
safety audits to s atisfy requirements of  FDA’s VQIP , to become eligible entities and seek food 
safety audits under  the Third-Party final rule. 
Consid ering the demand for food s afety audits und er the Third-Party program by foreign 
suppli ers sub ject to section  801(q) of the FD&C Act and those wanting to participate in VQIP , 
we expect that some  of the ABs and CBs operating globally will also h ave an incentive  to 
participate and comply with the  Third-Party final rule.  Under the three different scenarios 
discussed above, we  have estimated that 11 to 25 ABs will accredit CBs that will conduct  food 
safety audits of  foreign eligible entities  that offer food or feed for impo rt to the  United States.  
We also e stimate that a pproximately 91 to 207 CBs will be  accredited by the potential 11 to 25 
AB applicants; these CBs will  comply with the Third-Party final rule in order to participate in 
the program .  In addition, we expect that one CB will apply and participate in the third -party 
program via direct accre ditation by FDA under the Third -Party final rule (see table 9). 
Table  6.--Potential Number  of Importers Participating  in VQIP in its Initial  10 Years  
Scenario  Year  
1 2 3 4 5 6 7 8 9 10 
1 200 200 200 200 200 200 200 200 200 200 
2 200 288 376 464 552 562 579 596 614 632 
3 200 300 400 500 600 700 800 900 1,000  1,104  
 
Table  7.--Potential Number  of Foreign Suppliers (Section  806 of the FD&C Act)  Participating  in VQIP in its 
Initial  10 Years  
Scenario  Year  
1 2 3 4 5 6 7 8 9 10 
1 1,116  1,116  1,116  1,116  1,116  1,116  1,116  1,116  1,116  1,116  
2 1,116  1,607  2,098  2,589  3,080  3,136  3,231  3,326  3,426  3,527  
3 1,116  1,674  2,232  2,790  3,348  3,906  4,464  5,022  5,580  6,160  
 
Table  8.--Num ber of Respondents in the Third -Party Final Rule  
Eligible Entities  Scenario 1  Scenario 2  Scenario 3  
Section  801(q) of FD&C Act  75 75 75 
Section  806 of FD&C Act  1,116  3,527  6,160  
Total eligible entities  1,191  3,602  6,235  
 259 
Table 9.--Number of Respondents to the Third -Party Final Rule  
Status of ABs/CBs  Number of ABs/CBs  
Scenario 1  Scenario 2  Scenario 3  
ABs seeking recognition  11 17 25 
CBs seeking accreditation by recognized ABs  91 140 207 
CBs seeking accreditation by FDA  1 1 1 
Total CBs accredited  92 141 208 
 
Information Collection Burden Estimate :  We estimate the burden for this information 
collection as follows:  
 Recordkeeping Burden  
In summary, under Scenario 1, total one -time recordkeeping burden by 11 recognized 
ABs and 92 CBs accredited under the third -party program  is estimated at 25,792 hours (see table 
10).  Total annual recordkeeping burden by 11 recognized ABs and 92 CB s accredited under the 
third -party program  is estimated at 2,673 hours (see table 13).  
Under Scenario 2, total one -time recordkeeping burden by 17 recognized ABs and 141 
CBs accredited under the third -party program  is estimated at 41,640 hours (see table 11).  Total 
annual recordkeeping burden by 17 recognized ABs and 141 CBs  accredited under the third -
party program  s is estimated at 4,553 hours (see table 14). 
Under Scenario 3, total one -time recordkeeping burden by 25 recognized ABs and 208 
CBs accredite d under the third -party program  is estimated at 58,570 hours (see table 12).  Total 
annual recordkeeping burden by 25 recognized ABs and 208 CBs accredited under the third -
party program  is estimated at 6,253 hours (see table 15). 
For the purpose of this an alysis we assume that all ABs that apply for recognition in the 
program become recognized and all CBs that apply for accreditation are accredited.  260 
Table  10.--Scenario 1, Estimated One -Time Recordkeeping Burden  
21 CFR Part 1, 
Subpart M  No. of 
Recordkeepers  No. of Records 
per 
Recordkeeper  Total  One-
Time Records  Average Burden 
per Recordkeeping 
(in hours)  Total 
Hours  
§ 1.615  11 1 11 2 22 
§ 1.645  92 1 92 2 184 
§ 1.624(d)  11 1 11 160 1,760  
§ 1.657(d)  92 1 92 160 14,720  
Contract modification  11 8.27 91 2 182 
§ 1.651  92 48 4,416  2 8,832  
 §1.653(b)(2)  92 1 92 1 92 
Total One -Time Recordkeeping Burden  25,792  
Note:  There are no operations and maintenance costs associated with one -time recordkeeping burden.  
 
Table  11.--Scenario 2, Estimated One -Time Recordkeeping Burden  
21 CFR Part 1, 
Subpart M  No. of 
Recordkeepers  No. of 
Records per 
Recordkeeper  Total  One-
Time Records  Average Burden 
per Recordkeeping 
(in hours)  Total 
Hours  
§ 1.615  17 1 17 2 34 
§ 1.645  141 1 141 2 282 
§ 1.624(d)  17 1 17 160 2,720  
§ 1.657(d)  141 1 141 160 22,560  
Contract modification  17 8.23 140 2 280 
§ 1.651  141 55.4 7,811  2 15,623  
§ 1.653(b)(2)  141 1 141 1 141 
Total One -Time Recordkeeping Burden  41,640  
Note:  There are no operations and maintenance costs associated with one -time recordkeeping burden.  
 
Table  12.--Scenario 3, Estimated One -Time Recordkeeping Burden  
21 CFR Part 1, 
Subpart M  No. of 
Recordkeepers  No. of Records 
per 
Recordkeeper  Total  One-
Time Records  Average Burden 
per Recordkeeping 
(in hours)  Total 
Hours  
§ 1.615  25 1 25 2 50 
§ 1.645  208 1 208 2 416 
§ 1.624(d)  25 1 25 160 4,000  
§ 1.657(d)  208 1 208 160 33,280  
Contract modification  25 8.79 220 2 440 
§ 1.651  208 48.5 10,088  2 20,176  
§ 1.653(b)(2)  208 1 208 1 208 
Total One -Time Recordkeeping Burden  58,570  
Note:  There are no operations and maintenance costs associated with one -time recordkeeping burden.  
 
Table  13.--Scenario 1, Estimated Annual Recordkeeping Burden  
21 CFR Part 1, 
Subpart M  No. of 
Recordkeepers  No. of Records 
per 
Recordkeeper  Total  One-
Time 
Records  Average Burden 
per Recordkeeping 
(in hours)  Total 
Hours  
§ 1.625  11 397 4,367  0.025 (15 minutes)  1,092  
§ 1.624( c)  11 1 11 8 88 
§ 1.657(d)  92 1 92 8 736 
§ 1.652  92 48 4,416  0.083 (5 minutes)  367 
§ 1.653(b)(2)  92 48 4,416  0.083  (5 minutes)  367 
§ 1.656(c)  92 0.25 23 1 23 
Total Annual Recordkeeping Burden  2,673  
Note:  There are no operations and maintenance costs associated with one -time recordkeeping burden.  261 
 
Table  14.--Scenario 2, Estimated Annual Recordkeeping Burden  
21 CFR Part 1, 
Subpart M  No. of 
Recordkeepers  No. of Records 
per 
Recordkeeper  Total  One-
Time 
Records  Average Burden 
per Recordkeeping 
(in hours)  Total 
Hours  
§ 1.625  17 456 7,752  0.25 (15 minutes)  1,938  
§ 1.624( c)  17 1 17 8 136 
§ 1.657(d)  141 1 141 8 1,128  
§ 1.652  141 55.4 7,811  0.083 (5 minutes)  648 
§ 1.653(b)(2)  141 55.4 7,811  0.083  (5 minutes)  648 
§ 1.656(c)  141 0.25 35 1 35 
Total Annual Recordkeeping Burden  4,533 
Note:  There are no operations and maintenance costs associated with one -time recordkeeping  burden.  
 
Table  15.--Scenario 3, Estimated Annual Recordkeeping Burden  
21 CFR Part 1, 
Subpart M  No. of 
Recordkeepers  No. of Records 
per 
Recordkeeper  Total  One-
Time 
Records  Average Burden 
per Recordkeeping 
(in hours)  Total 
Hours  
§ 1.625  25 426 10,650  0.25 (15 minutes)  2,663  
§ 1.624( c)  25 1 25 8 200 
§ 1.657(d)  208 1 208 8 1,664  
§ 1.652  208 48.5 10,088  0.083 (5 minutes)  837 
§ 1.653(b)(2)  208 48.5 10,088  0.083  (5 minutes)  837 
§ 1.656(c)  208 0 52 1 52 
Total Annual Recordkeeping Burden  6,253  
Note:  There are no operations and maintenance costs associated with one -time recordkeeping burden.  
 
Sections 1.615 and 1.645 of the Third -Party final rule require that at the time an AB 
submits an application for recognition (under §  1.630 of the Third -Party final rule) or a CB 
submits an application for direct accreditation (under §  1.660, or where applicable under 
§ 1.670), the AB or CB must demonstrate that it has implemented written procedures to 
adequately establish, control, and maintain records for the period of time necessary to meet its 
contractual and legal obli gations pertaining to the third -party program.  Currently, ABs maintain 
recordkeeping protocols relating to their operations; however, we expect that ABs will review 
their recor dkeeping protocols and, if necessary, modify them to meet the requirements of §  1.615 
of the Third -Party final rule before submitting applications for recognition.  We believe that the 
records requirements for ABs in §  1.615 and CBs in §  1.645 would consti tute a new one -time 
burden for the 11 to 25 ABs in each of the three considered scenario, and 92 to 208 CBs 
respectively.  We expect that it would take no more than 2 hours for an AB or a CB to modify its 262 
recordkeeping protocol to comply with the written r ecordkeeping requirements described in 
§§ 1.615 and 1.645 of the Third -Party final rule (see tables 10 to 12).  Therefore, under Scenario 
1, we estimate that it would take 22 hours (2 hours/AB × 11 ABs) for ABs to comply with 
§1.615 (34 hours under Scenari o 2, and 50 hours under Scenario 3) (see tables 10 to 12).  We 
estimate 184 hours (2 hours/CB × 92 CBs) for CBs to comply with §  1.645 of the Third -Party 
final rule (282 hours under Scenario 2, and 416 hours under Scenario 3) (see tables 10 to 12). 
 Sectio n 1.625 of the Third -Party final rule requires that an AB that has been 
recognized maintain records documenting requests by CBs for accreditation from the AB (per §  
1.660), challenges to adverse accreditation decisions (§  1.620(c)), monitoring activities o f its 
accredited CBs (§  1.621), self -assessments and corrective actions (§  1.622), copies of regulatory 
audit reports submitted by its accredited CBs (§  1.656), and copies of records of reports or 
notifications made to us, as required by §  1.623.  A recogn ized AB’s requirements for reporting 
and notifications per §  1.623 of the Third -Party final rule include submission of results of its 
annual performance assessment of each of its accredited CBs (§  1.623(a)) and the results of its 
self-assessment (§  1.623(b )) (see tables 20 to 22).  A recognized AB also must notify us 
immediately upon granting, withdrawing, suspending, reducing the scope of accreditation of a 
CB or upon its determination that a CB it accredited issued a food or facility certification in 
violation of subpart M, pursuant to §  1.623(c) of the Third -Party final rule.  Additionally, a 
recognized AB must notify us within 30 days after making significant changes to its operations 
that would affect the manner in which it complies with the Third -Party final rule (§  1.623(d)).  
 Under current practice, ABs maintain records documenting requests by CBs for 
accreditation, monitoring activities of CBs they have accredited, and self -assessments and 
corrective actions.   The records currently maintained by  ABs are similar to those that would be 263 
required of a recognized AB under §  1.623 of the Third -Party final rule.  However, CBs do not 
currently send copies of audit reports of their clients (food facilities) to their ABs.  Therefore, an 
AB’s maintenance of  records pertaining to regulatory audit reports submitted by CBs they have 
accredited is considered as a new recordkeeping burden for recognized ABs.  We expect that it 
would take no more than 15 minutes (0.25 hour) for a recognized AB to file a regulatory  audit 
report submitted by its accredited CBs.  Under Scenario 1, we estimate the burden for 11 
recognized ABs to maintain regulatory audit reports that were submitted to them by their 
accredited CBs.  We estimate that following the implementation of the T hird-Party final rule, 
under Scenario 1, each recognized AB will accredit approximately 8.27 CBs under the program 
(average of 10 -year period) (8.23 CBs/AB under Scenario 2; 8.79 CBs/AB under Scenario 3). In 
addition, under Scenario 1, we estimate that eac h CB accredited under the third -party program , 
on average, will conduct regulatory audits on approximately 48 eligible entities a year (average 
of 10 -year period) (55.4 foreign suppliers per CB under Scenario 2; 48.5 foreign suppliers per 
CB under Scenario  3).  Under Scenario 1, we expect that each recognized AB will receive, on 
average, 397 regulatory audit reports (48 regulatory audit reports/CB × 8.27 CBs/AB) from its 
CBs annually resulting in a total of 4,367 records per year (397 audit reports/AB × 11 ABs). 
Under Scenario 2, we expect that each recognized AB will receive, on average, 456 regulatory 
audit reports (55.4 regulatory audit reports/CB × 8.23 CBs/AB) from its CBs annually resulting 
in a total of 7,752 records per year (456 audit reports/AB × 17 ABs). Under Scenario 3, we 
expect that each recognized AB will receive, on average, 426 regulatory audit reports (48.5 
regulatory audit reports/CB × 8.79 CBs/AB) from its CBs annually resulting in a total of 10,650 
records per year (426 audit reports/AB × 25 ABs).  Total annual burden of recordkeeping 
requirement for recogniz ed AB under §  1.625 of the Third -Party final rule is estimated at 1,092 264 
hours (4,367 records × 0.25hours/record) under Scenario 1 (1,938 hours under Scenario 2; 2,663 
hours under Scen ario 3) (see tables 13 to 15). 
 Section 1.624(d) of the Third -Party final rule requires each recognized AB 
maintain on its Web site an up -to-date list of CBs it  has accredited under the Third -Party final 
rule and for each CB identify the duration and scope  of accreditation and date(s) on which the 
CB paid the AB any fee or reimbursement associated with such accreditation.  Recognized ABs 
must also include information about changes in accreditation status of third -party certification 
bodies.  Our review of A B Web sites found that none of the ABs reviewed publish all the 
information that is required by §  1.620(d) of the Third -Party final rule on their Web sites.  We 
estimate that each AB, on average, would initially spend approximately 160 hours to update its 
Web  page to conform with this section of the Third -Party final rule.  Under Scenario 1, the one -
time burden of conforming to §  1.624(d) of the Third -Party final rule by 11 recognized ABs is 
estimated at approximately 1,760 hours (11 ABs × 160 hours/AB) (see table 10).  Under 
Scenario 2, the one -time burden of conforming to §  1.624(d) of the Third -Party final rule by 17 
recognized ABs is estimated at approximately 2,720 hours (17 ABs × 160 hours/AB) (see table 
11).  Under Scenario 3, the on e-time burden of conforming to §  1.624(d) of the Third -Party final 
rule by 25 recognized ABs is estimated at approximately 4,000 hours (25 ABs × 160 hours/AB) 
(see table 12).  In addition, we estimate that each recognized AB would spend 8 hours annually, 
following the initial year, to update information as required by §  1.624(d) of the Third -Party final 
rule.  Under Scenario 1, the annual hourly burden for 11 recognized ABs to update their Web 
pages to conform to disclosure of information requirement per § 1.624(d) of the Third -Party final 
rule is estimated at 88 hours (8 hours/AB × 11 ABs) (136 hours under Scenario 2; 200 hours 
under Scenario 3) (see tables 13 to 15).  265 
 Similarly, §  1.657(d) of the Third -Party final rule requires a CB accredited in 
complianc e with the Third -Party final rule to maintain on its Web site an up -to-date list of 
eligible entities which it has issued certifications under this subpart.  For each such eligible entity 
the Web site also must identify the duration and scope of the certif ication and date(s) on which 
the eligible entity paid the CB accredited under the third -party program  any fee or 
reimbursement associated with such audit or certification.  In the Third -Party final Regulatory 
Impact Analysis, we estimate that following the  implementation of the Third -Party final rule and 
VQIP draft guidance, there will be approximately 91 CBs accredited by recognized ABs and 1 
directly -accredited CB under Scenario 1 (140 CBs and one directly -accredited CB under 
Scenario 2; 207 CBs and 1 directly -accredited CB under Scenario 3).  Under Scenario 1, the one -
time recordkeeping burden of 92 CBs accredited under the third -party program  to comply with 
§ 1.657(d) of the Third -Party final rule is estimated at 14,720 hours (160 hours/CB × 92 CBs) 
(22,560 hours under Scenario 2; 33,280 hours under Scenario 3) (see tables 10 to 12).  In 
addition, we estimate that each CB would spend 8 hours annually, following the initial year, to 
update information as required by §  1.657(d) of the Third -Party final rule .  Under Scenario 1, 
annual hourly burden for 92 CBs accredited under the third -party program  to update their Web 
pages to conform to disclosure of information require ment per §  1.657(d) of the Third -Party final 
rule is estimated at 736 hours (8 hours/CB × 92 CBs) (1,128 hours under Scenario 2; 1,664 hours 
under Scenario 3) (see tables 13 to 15). 
There are certain provisions within the Third -Party final rule that may require ABs to 
modify their contracts with their CBs in order to comply with the Third -Party final rule.  
Therefore, it is expected that recognized ABs will modify their contracts with their accredited 
CBs to be able to conduct activities such as conducting unannounced audits of their accredited 266 
CBs’ facilities.  Minor modifications or addenda t o contracts with standard language provided by 
provisions in the Third -Party final rule would consist of no more than 1 hour by an AB executive 
and 1 hour by a legal counsel representing the AB.  As we discussed, following the 
implementation of the Third -Party final rule, we expect that each recognized AB will accredit 
approximately 8.27 CBs (8.23 CBs/AB under Scenario 2; 8.79 CBs/AB under Scenario 3).  
Therefore, under Scenario 1,  a total of 91 contracts (8.27 contracts/AB × 11 ABs) (140 contracts 
under S cenario 2; 220 contracts under Scenario 3) are expected to be modified to reflect changes 
in contractual obligations between each recognized AB and its accredited CBs under the Third -
Party final rule (see tables 10 to 12).  The one -time burden of initial m odification of 91 contracts 
between 11 recognized ABs and their respective accredited CBs is approximately 182 hours (91 
contracts × 2 hours/contract) (280 hours under Scenario 2; 440 hours under Scenario 3) (see 
tables 10 to 12). 
Similarly, CBs accredited  by recognized ABs would need to modify or create new 
contracts with their client eligible entities in order to gain access to any records and any area of 
the facility, its process(es), and food of the eligible entity relevant to the scope and purpose of 
audit being performed by the CB (§  1.651).  Considering that each of the expected 92 CBs 
accredited under the third -party program , under Scenario 1, will each have approximately 48 
client eligible entities, we expect that approximately 4,416 contracts (48 c ontracts/CB × 92 CBs) 
between CBs accredited under the third -party program  and eligible entities will be modified 
(7,811 contracts scenario 2; 10,088 contracts under Scenario 3) (see tables 10 to 12).  Under 
Scenario 1, the one -time burden of initial modif ication of 4,416 contracts between 92 CBs 
accredited under the third -party program  and their respective client eligible entities is 267 
approximately 8,832 hours (4,416 contracts × 2 hours/contract) (15,623 hours under Scenario 2; 
20,176 hours under Scenario 3 ) (see tables 10 to 12). 
Section 1.652 of the Third -Party final rule requires that CBs accredited under the third -
party program  include certain information in reports of food safety audits.  We believe that some 
information such as the FDA food facility re gistration number (where applicable) of the facility 
subject to the audit are currently not included in food safety audits conducted by CBs accredited 
under other programs .  Although this information may not be required as part of the Third -Party 
program, we have conservatively included the burden of providing such information in this 
analysis.  We expect that it would take about 5 minutes (0.083 hour), on average, by a CB 
accredited under the third -party program  to include additional information, as required in 
§ 1.652, in reports of food safety audits.  Therefore, at a minimum, under Scenario 1, each CB 
accredited under the third -party program  must modify a regulatory audit report for each of its 48 
eligible ent ities (55.4 eligible entities per CB in Scenario 2; 48.5 eligible entities per CB in 
Scenario 3) every year.  Under Scenario 1, total annual records of 92 CBs accredited under the 
third -party program  modifying regulatory audit reports of their client eligi ble entities is estimated 
at 4,416 records (92 CBs × 48 eligible entities/CB × 1 record/eligible entity) (7,811 records 
under Scenario 2; 10,088 records under Scenario 3).  Annual recordkeeping burden of CBs 
accredited under the third -party program , per § 1.652 of the Third -Party final rule, is estimated at 
367 hours (4,416 records × 0.083 hour/record) for Scenario 1 (648 hours for Scenario 2; 837 
hours for Scenario 3) (see tables 13 to 15).  
Accredited third -party CBs will incur additional recordkeeping co sts associated with 
modifying existing certification templates to meet the requirements of § 1.653(b)(2).  For 
example, we are requiring accredited CBs to provide a certification number that follows an FDA 268 
numeric designation.  We have included the burden of providing such information in this 
analysis because we know that CBs currently do not use an FDA designation in numbering their 
certificates.  To the extent that any of the elements in § 1.653(b)(2) are already included in 
current certificates issued by  some CBs, such as the date(s) and scope of the audit, the 
recordkeeping burden may be overestimated.  We expect that it will take no more than 1 hour, on 
average, to change the design of certifications issued by CBs accredited under the third -party 
progra m.  Under Scenario 1, we estimate a one -time recordkeeping burden of modifying the 
design of the certifications of 92 CBs accredited under the third -party program  at 92 hours (92 
CBs × 1 hour/CB) (141 hours under Scenario 2; 208 hours under Scenario 3) (se e tables 16 to 
18).  
We expect that the burden to fill additional information on a certification that is issued is 
5 minutes (0.083 hour).  Therefore, under Scenario 1, the annual burden of §  1.653(b)(2) is 
estimated at 367 hours (92 CBs × 1 certificate/en tity × 48 entities/CB × 0.083 hour/certificate) 
(see table 19).  Under Scenario 2, the annual burden of §  1.653(b)(2) is estimated at 648 hours 
(141 CBs × 1 certificate/entity × 55.4 entities/CB × 0.083 hour/certificate) (see table 20).  
Finally, under Scenario 3, the annual burden of §  1.653(b)(2) is estimated at 837 hours (208 CBs 
× 1 certificate/entity × 48.5 entities/CB × 0.083 hour/certificate) (see table 21).   
Section 1.656(c) of the Third -Party final rule requires that CBs accredited under the th ird-
party program  report to us any condition, found during a regulatory or consultative audit of an 
eligible entity, which could cause or contribute to a serious risk to the public health.  We believe 
that these occurrences are rare and may occur once ever y 4 years, or 0.25 times per year.  
Reporting serious hazard conditions would consist of the onsite audit agent of a CB accredited 
under the third -party program  to document the event as a record and to immediately submit the 269 
record to us.  Therefore, under  Scenario 1, the annual number of records prepared by 92 CBs 
accredited under the third -party program  is estimated at 23 (0.25 records/CB × 92 CBs) (35 
records under Scenario 2; 52 records under Scenario 3).  It is expected that a CB accredited 
under the t hird-party program  would take no more than 1 hour to prepare such record 
(notification).  Under Scenario 1, annual burden of preparation of rec ords per §  1.656(c) of the 
Third -Party final rule by 92 CBs accredited under the third -party program  is estimated  at 23 
hours (23 records × 1 hour/record; see table 13) (35 hours for Scenario 2, and 52 hours for 
Scenario 3; see tables 14 to 15). 
We also acknowledge that an accreditation body seeking to challenge a denial of its 
application for recognition, renewal of recognition, or reinstatement of recognition will incur 
costs in compiling information to support its request for reconsideration un der § 1.691 or its 
request for internal Agency review under § 1.692.  A third -party certification body seeking to 
challenge a denial of its application for direct accreditation, renewal of direct accreditation, or 
reaccreditation as a directly accredited t hird-party certification body will incur costs in compiling 
information to support its request for reconsideration under § 1.691 or its request for internal 
Agency review under § 1.692, as will any accredited third -party certification body seeking to 
chall enge a denial of its request for a waiver of the conflict of interest requirement of § 1.650(b) 
or a waiver extension.  We anticipate that most accreditation bodies and third -party certification 
bodies who seek to participate in our program will carefully consider the program requirements 
before applying to, or joining, the program or before submitting a waiver request.  We anticipate 
the submission of challenges under § 1.691 or § 1.692 to be an infrequent event, and one that 
most program participants will  not encounter.  Therefore, we are not calculating costs associated 
with the compiling of information to support a request for reconsideration under § 1.691 or a 270 
request for internal agency review under § 1.692 by an accreditation body seeking to challenge  a 
denial of its application for recognition, renewal of recognition, or reinstatement of recognition; 
by an third -party certification body seeking to challenge a denial of its application for direct 
accreditation, renewal of direct accreditation, or reacc reditation as a directly accredited third -
party certification body; or by an accredited third -party certification body seeking to challenge a 
denial of its request for a waiver of the conflict of interest requirement of § 1.650(b) or a waiver 
extension.  
Reporting Burden  
In summary, under Scenario 1, total one -time reporting burden by 11 recognized ABs and 
92 CBs accredited under the third -party program  is estimated at 960 hours (see table 16).  Under 
Scenario 2, total one -time reporting burden by 17 recognized ABs and 141 CBs accredited under 
the third -party program  is estimated at 1,440 hours (see table 17). Under Scenario 3, total one -
time reporting burden by 25 recognized ABs and 208 CBs accredited under the third -party 
program  is estimated at 2,080 hours (see table 18).  Total annual reporting burden, under 
Scenarios 1  to 3 is estimated between 3,466 and 7,919 hours (see tables 19 to 21). 
Table  16.--Scenario 1, Estimated One -Time Reporting Bu rden 
21 CFR Part 1, 
Subpart M  No. of 
Recordkeepers  No. of Records 
per Recordkeeper  Total One -
Time Records  Average Burden per 
Recordkeeping (in 
hours)  Total 
Hours  
§1.630  11 1 11 80 880 
§1.670(a -b) 1 1 1 80 80 
Total One -Time Reporting Burden  960 
Note: There are no operations and maintenance costs associated with one -time reporting burden.  
 
Table  17.--Scenario 2, Estimated One -Time Reporting Burden  
21 CFR Part 1, 
Subpart M  No. of 
Recordkeepers  No. of Records 
per Recordkeeper  Total One -
Time Records  Averag e Burden per 
Recordkeeping (in 
hours)  Total 
Hours  
§1.630  17 1 17 80 1,360  
§1.670(a -b) 1 1 1 80 80 
Total One -Time Reporting Burden  1,440  
Note: There are no operations and maintenance costs associated with one -time reporting burden.  
 271 
Table  18.--Scenario 3, Estimated One -Time Reporting Burden  
21 CFR Part 1, 
Subpart M  No. of 
Recordkeepers  No. of Records 
per Recordkeeper  Total One -
Time Records  Average Burden per 
Recordkeeping (in 
hours)  Total 
Hours  
§1.630  25 1 25 80 2,000  
§1.670(a -b) 1 1 1 80 80 
Total One-Time Reporting Burden  2,080  
Note: There are no operations and maintenance costs associated with one -time reporting burden.  
 
Table  19.--Scenario 1, Estimated Annual Reporting Burden  
21 CFR Part 1, 
Subpart M  No. of 
Recordkeepers  No. of Records 
per Recordkeeper  Total 
Annual 
Records  Average Burden 
per Recordkeeping 
(in hours)  Total 
Hours  
§1.634  11 1 11 8 88 
§1.673  1 1 1 10 10 
§1.623(a)  11 8.27 91 0.25 (15 minutes)  23 
§1.623(b)  11 1 11 0.25 (15 minutes)  3 
§1.653(b)(1)  92 48 4,416  0.25 (15 minutes)  1,104  
§1.656(a)1 91 48 4,368  0.25 (15 minutes)  1,092  
§1.656(a)2 91 48 4,368  0.25 (15 minutes)  1,092  
§1.656(a)3 1 48 48 0.25 (15 minutes)  12 
§1.656(b)4 91 1 91 0.25 (15 minutes)  23 
§1.656(b)5 1 1 1 0.25 (15 minutes)  1 
§1.656(c)  92 0.25 23 0.25 (15 minutes)  6 
§1.656(e)6  92 0.25 23 0.25 (15 minutes)  6 
§1.656(e)7  91 0.25 23 0.25 (15 minutes)  6 
Total Annual Reporting Burden  3,446 
Note: There are no operations and maintenance costs associated with annual reporting burden.  
1 Annual reporting of regulatory audit reports by CBs accredited by recognized ABs to their accrediting ABs.  
2 Annual reporting of regulatory audit reports by CBs accredited by recognized ABs to the FDA.  
3 Annual reporting of regulatory audit reports by dir ectly accredited CBs to the FDA.  
4 Annual reporting of self -assessment by accredited CBs to their recognized ABs.  
5 Annual reporting of self -assessment by directly -accredited CBs to the FDA.  
6 Annual reporting of serious risk to public health by CBs accred ited under the third -party program to eligible 
entities.  
7 Annual reporting of serious risk to public health by accredited CBs to their recognized ABs.  
 
Table  20.--Scenario 2, Estimated Annual Reporting Burden  
21 CFR Part 1, 
Subpart M  No. of 
Recordkeepers  No. of Records 
per Recordkeeper  Total 
Annual 
Records  Average Burden 
per Recordkeeping 
(in hours)  Total 
Hours  
§1.634  17 1 17 8 136 
§1.673  1 1 1 10 10 
§1.623(a)  17 8.23 140 0.25(15 minutes)  35 
§1.623(b)  17 1 17 0.25 (15 minutes)  4 
§1.653(b)(1)  141 55.4 7,811  0.25 (15 minutes)  1,953  
§1.656(a)1 140 55.4 7,756  0.25 (15 minutes)  1,939  
§1.656(a)2 140 55.4 7,756  0.25 (15 minutes)  1,939  
§1.656(a)3 1 55.4 55 0.25 (15 minutes)  14 
§1.656(b)4 140 1 140 0.25 (15 minutes)  35 
§1.656(b)5 1 1 1 0.25 (15 minutes)  1 
§1.656(c)  141 0.25 35 0.25 (15 minutes)  9 
§1.656(e)6  141 0.25 35 0.25 (15 minutes)  9 272 
§1.656(e)7  140 0.25 35 0.25 (15 minutes)  9 
Total Annual Reporting Burden  6,093  
Note: There are no operations and maintenance costs associated with annual reporting  burden.  
1 Annual reporting of regulatory audit reports by CBs accredited by recognized ABs to their accrediting ABs.  
2 Annual reporting of regulatory audit reports by CBs accredited by recognized ABs to the FDA.  
3 Annual reporting of regulatory audit repo rts by directly -accredited CBs to the FDA.  
4 Annual reporting of self -assessment by CBs to their recognized ABs.  
5 Annual reporting of self -assessment by directly -accredited CBs to the FDA.  
6 Annual reporting of serious risk to public health by CBs accredi ted under the third -party program to eligible 
entities.  
7 Annual reporting of serious risk to public health by CBs to their recognized ABs.  
 
Table  21.--Scenario 3, Estimated Annual Reporting Burden  
21 CFR Part 1, 
Subpart M  No. of 
Recordkeepers  No. of Records 
per 
Recordkeeper  Total 
Annual 
Records  Average Burden 
per Recordkeeping 
(in hours)  Total 
Hours  
§1.634  25 1 25 8 200 
§1.673  1 1 1 10 10 
§1.623(a)  25 8.79 220 0.25 (15 minutes)  55 
§1.623(b)  25 1 25 0.25 (15 minutes)  6 
§1.653(b)(1)  208 48.5 10,088  0.25 (15 minutes)  2,522  
§1.656(a)1 207 48.5 10,040  0.25 (15 minutes)  2,510  
§1.656(a)2 207 48.5 10,040  0.25 (15 minutes)  2,510  
§1.656(a)3 1 55.4 55 0.25 (15 minutes)  14 
§1.656(b)4 207 1 207 0.25 (15 minutes)  52 
§1.656(b)5 1 1 1 0.25 (15 minutes)  1 
§1.656(c)  208 0.25 52 0.25 (15 minutes)  13 
§1.656(e)6  208 0.25 52 0.25 (15 minutes)  13 
§1.656(e)7  207 0.25 52 0.25 (15 minutes)  13 
Total Annual Reporting Burden  7,919  
Note: There are no operations and maintenance costs associated with annual reporting burden.  
1 Annual reporting of regulatory audit reports by CBs accredited by recognized ABs to their accrediting ABs.  
2 Annual reporting of regulatory audit reports by CBs accredited by recognized ABs to the FDA.  
3 Annual reporting of regulatory audit reports by directly -accredited CBs to the FDA.  
4 Annual reporting of self -assessment by CBs to their recognized ABs.  
5 Annual reporting of self -assessment by directly -accredited CBs to the FDA.  
6 Annual reporting of se rious risk to public health by CBs accredited under the third -party program to eligible 
entities.  
7 Annual reporting of serious risk to public health by CBs to their recognized ABs.  
 
Section 1.630 of the Third -Party final rule allows for any AB to apply fo r recognition.  
Under Scenario 1, we estimate that approximately 11 ABs would apply for recognition.  We 
estimate that it will take 80 person -hours to compile all the relevant information and complete 
the application for recognition.  The initial applicati on for recognition is a one -time burden for 
each AB that applies.  Under Scenario 1, the one -time initial application burden for 11 ABs is 
estimated at 880 hours (11 applications × 80 hours/application) (see table 16).  The one -time 273 
initial application bur den for 17 ABs, under Scenario 2 (25 ABs under Scenario 3), is estimated 
at 1,360 hours (2,000 hours under Scenario 3) (see tables 17 and 18).  The duration of 
recognition for a recognized AB will not exceed 5 years per §  1.632 of the Third -Party final rul e.  
Therefore, it is expected that each of the recognized ABs would apply to renew its recognition 
every 5 years per §  1.634 of the Third -Party final rule.  We expect that applications for renewal 
of recognition will take significantly less time to prepare .  We use 50  percent of the amount of 
effort to prepare and submit an application for renewal of recognition.  Therefore, it is expected 
that, on average, each recognized AB will spend 40 hours every 5 years (after the initial 
application) to complete and submit an application for renewal of its recognition, or 
approximately 8 hours per year (40 hours ÷ 5 years) for each AB.  Therefore, the annual burden 
of completing the renewal of recognition application by 11 ABs, under Scenario 1, is 88 hours 
(11 applic ations × 8 hours/application) per year (136 hours per year for 17 ABs under Scenario 
2; 200 per hour for each of 25 ABs under Scenario 3) (see tables 19 to 21). 
Similarly, § 1.670(a ) and ( b) of the Third -Party final rule allows for CBs to apply to us 
for direct accreditation, when the criteria for direct accreditation are met.  We estimate that 
approximately one CB would apply for direct accreditation.  It is expected that the application 
for direct accreditation would require the same amount of effort as does an AB’s application for 
recognition.  Hence, we estimate that the initial application for direct accreditation would take 
80-person hours.  The one -time initial application burden for 1 CB, for each scenario, is 
estimated at 80 hours (1 application × 80 hours/application) (see tables 16 to 18).  The duration 
of accreditation for a directly -accredited CB will not exceed 4  years, per §  1.671 of the Third -
Party final rule.  Therefore, it is expected that each of the expected directly -accredited CBs 
would apply to renew its accreditation every 4 years, per §  1.673 of the Third -Party final rule.  274 
We expect that directly  accredited CBs use 50  percent amount of effort, or 40 person -hours, for 
their initial application for direct accreditation, yielding an average of 10 hours per year.  
Therefore, the annual burden of completing the application for renewal by 1 directly -accredited 
CB is 10 hours (1 application × 10 hours/application) per year (s ee tables 19 to 21). 
For the purposes of the Third -Party final economic and PRA analyses, we have estimated 
costs assuming that, during the application process, affected entities will do their paperwork 
properly and completely the first time.  If we assume d a less consistent outcome, one that would 
result in recognition denials, the initial burden might increase.  
Section 1.623(a) of the Third -Party final rule requires that recognized ABs annually 
conduct comprehensive assessments of the performance of CBs they have accredited and submit 
the results of the assessments to us within 45 days of their completion.  We expect that it would 
take no more than 15 minutes (0.25 hour) for a recognized AB to electronically submit the 
assessment of each its accredited CB s.  Following the implementation of the Third -Party final 
rule and VQIP draft guidance, we expect, on average, each recognized AB would accredit 
approximately 8.27 CBs (8.23 CBs under Scenario 2; 8.79 under Scenario 3).  Therefore, under 
Scenario 1, each r ecognized AB would submit, on average, approximately 91 copies of 
assessments of performance of their accredited CBs (8.27 assessments/AB × 11 ABs) (140 
assessments under Scenario 2; 220 under Scenario 3).  Under Scenario 1, annual reporting of 91 
assessme nts by 11 recognized ABs is estimated at 23 hours (91 submission of assessments × 
0.25 hour/submission) (35 hours under Scenario 2; 55 hours under Scenario 3) (see tables 19 to 
21).   
Section 1.623(b) of the Third -Party final rule requires that recognized ABs annually 
conduct a self -assessment and submit the assessments within 45 days of their completion.  We 275 
expect that it would take no more than 15 minutes for an AB to electronically submit a copy of 
its self -assessment.  Under Scenario 1, annual reportin g of 11 self -assessments by 11 recognized 
ABs is estimated at 3 hours (11 submission of self -assessments × 0.25 hour/submission) (4 hours 
under Scenario 2; 6 hours under Scenario 3) (see tables 10 to 21).   
Section 1.656(a) of the Third -Party final rule re quires that a CB accredited under the 
third -party program  must submit the regulatory audit reports it conducts to us and to the AB that 
granted its accreditation (where applicable) within 45 days after completing such audit.  In the 
Third -Party final econo mic analysis, we estimate that following the implementation of the Third -
Party final rule, there will be 11 recognized ABs that accredit 91 CBs (17 recognized ABs and 
140 accredited CBs under Scenario 2; 25 recognized ABs and 207 accredited CBs under 
Scena rio 3), and we will directly accredit one CB.  In addition, we estimated that each CB 
accredited under the third -party program , on average, conducts food safety audits and certifies 48 
eligible entities under Scenario 1 (55.4 eligible entities/CB under Sce nario 2; 48.5 eligible 
entities/CB under Scenario 3).  Therefore, under Scenario 1, CBs accredited by recognized ABs 
will annually submit 4,368 regulatory audit reports (91 CBs × 48 reports/CB) to their accrediting 
ABs and 4,368 reports to us (see table 19). Similarly, under Scenarios 2 and 3, CBs accredited by 
recognized ABs will annually submit 7,756 and 10,040 regulatory audit reports to their 
accrediting ABs and the FDA, respectively (see tables 20 and 21).  Under Scenario 1, the 
directly -accredited CB will annually submit 48 regulatory audit reports (1 CB × 48 reports/CB) 
(see table 19).  The number of eligible entities per directly -accredited CB increases to 55.4 in 
Scenario 2.   We assume that the number of eligible entities per directly -accredited CBs  remains 
the same for Scenario 3.  We expect that it would take no more than 15 minutes (0.25 hour) for a 276 
CB accredited under the third -party program  to electronically submit a copy of the regulatory 
report it conducts to us and to its AB (where applicable).   
Under Scenario 1, annual reporting burden for CBs accredited by recognized ABs is 
estimated at 1,092 hours (4,368 reports × 0.25 hours/report) f or submitting copies of regulatory 
audit reports they have conducted to their accrediting ABs and 1,092 hours for submitting the 
same records to us (see table 19).  Under Scenario 2, annual reporting burden for CBs accredited 
by recognized ABs is estimated  at 1,939 hours (7,756 reports × 0.25 hours/report) for submitting 
copies of regulatory audit reports they have conducted to their accrediting ABs and 1,939 hours 
for submitting the same records to us (see table 20).  Similarly, under Scenario 3, annual 
reporting burden for CBs accredited by recognized ABs is estimated at 2,510 hours (10,040 
reports × 0.25 hours/report) for submitting copies of regulatory audit reports they have conducted 
to their accrediting ABs and 2,510 hours for submitting the same reco rds to us (see table 21). 
Under Scenario 1, annual burden for submission of regulatory audit reports by directly -
accredited CBs is estimated at 12 hours (48 reports × 0.25 hours/report) (14 hours for Scenarios 
2 and 3) (see tables 19 to 21).  
Section 1.656 (b) of the Third -Party final rule requires CBs accredited under the third -
party program  to submit reports of their annual self -assessments electronically to their ABs, or in 
the case of direct accreditation to us, within 45 days of the anniversary date of their accreditation 
under subpart M.  We expect that it would take no more than 15 minutes (0.25 hour) for a CB 
accredited under the third -party program  to electronically send a copy of its annual self -
assessment to its AB or us (as applicable).  Under Sce nario 1, the annual burden for CBs 
accredited by recognized ABs is estimated at 23 hours (91 self -assessments × 0.25 hour/self -
assessment; see table 19) (35 hours under Scenario 2 and 52 hours under Scenario 3; see tables 277 
20 and 21).  Annual burden for sub mission of self -assessments by one directly -accredited CB is 
estimated at 0.25 hour (1 self -assessment × 0.25 hour/self -assessment; see tables 19 to 21) 
(rounded to 1 hour).  
As we di scussed, §  1.656(c) of the Third -Party final rule requires that a CB accre dited 
under the third -party program  report to us any condition, found during a regulatory or 
consultative audit of an eligible entity, which could cause or contribute to a serious risk to the 
public health.  In the Recordkeeping Burden section above, we es timated that such events are 
expected to occur once every 4 years, or 0.25 per year.  We expect that it would take no more 
than 15 minutes (0.25 hour) for a CB accredited under the third -party program  to electronically 
send a copy of its notification to us .  Therefore, under Scenario 1, the total number of 
notifications sent to us on an annual basis per § 1.656(c) of the Third -Party final rule is estimated 
at 23 (92 CBs × 0.25 records/CB) (35 notifications under Scenario 2; 52 notifications under 
Scenario 3 ).  Under Scenario 1, annual burden for submitting a notification under § 1.656(c) of 
the Third -Party final rule to us by CBs accredited under the third -party program  is estimated at 6 
hours (23 records × 0.25 hour/record) (9 hours under Scenario 2; 13 hou rs under Scenario 3) (see 
tables 19 to 21).  
Following reporting under § 1.656(c), a CB accredited under the third -party program  is 
requir ed under §  1.656(e) of the Third -Party final rule to immediately notify the eligible entity 
and its accrediting AB of any conditions identified during the audit which triggered the reporting 
requirement per §  1.656(c) of the Third -Party final rule.  Under Scenario 1, total number of 
notification sent to eligible entities by 141 CBs accredited under the third -party program  is 
estimated at 23 (92 CBs × 0.25 records/CB) (35 notifications under Scenario 2; 52 notifications 
under Scenario 3) while the number of notifications sent to recognized ABs by their accredited 278 
CBs is estimated at 23 (91 CBs × 0.25 records/CB) (35 under S cenario 2; 52 under Scenario 3).  
Under Scenario 1, annual burden of submitting a notification under §  1.656(e) of the Third -Party 
final rule to affected eligible entities and ABs by accredited CBs is estimated at 6 hours (9 hours 
under Scenario 2; 13 hour s under Scenario 3) (see tables 19 to 21).  
XVII I.  Analysis of Environmental Impact  
We have determined under 21 CFR 25.30(j) that this action is of a type that does not 
individually or cumulatively have a significant effect on the human environment.  Ther efore, 
neither an environmental assessment nor an environmental impact statement is required.  
XIX.  Federalism  
We have analyzed the final rule in accordance with the principles set forth in Executive 
Order 13132.  We have determined that the rule does not contain policies that have substantial 
direct effects on the States, on the relationship between the National Government and the States, 
or on the distribution of power and responsibilities among the various levels of government.  
Accordingly, we conclude that the rule does not contain policies that have federalism 
implications as defined in the Executive Order and, consequently, a federalism summary impact 
statement is not required.  
XX.  References  
The following references have been placed on display in th e Division of Dockets 
Management (see ADDRESSES) and may be seen by interested persons between 9 a.m. and 4 
p.m., Monday through Friday, and are available electronically at http://www.regulations.gov . We 
have  verified the Web site addresses, but we are  not responsible for any subsequent changes to 
Web sites after this document publishes in the Federal Register . 279 
1.  FDA, “ Transcript:  FSMA Proposed Rules on Foreign Supplier Verification 
Programs and the Accreditation of Third -Party Auditors/Certification Bod ies, Public 
Meeting, Day One, September 19, 2013 .”  Available in Docket No. FDA -2011 -N-0143.  
2.  FDA, “Transcript:  FSMA Proposed Rules on Foreign Supplier Verification 
Programs and the Accreditation of Third -Party Auditors/Certification Bodies, Public 
Meeting, Day Two, September 20, 2013. ”  Available in Docket No. FDA -2011 -N-0143.  
3.  FDA, “FDA Office of Foods and Veterinary Medicine Memorandum to the 
Division of Dockets Management on FDA Records of Outreach  Sessions ,” November 21, 
2013.   Available in Docket No. FDA -2011 -N-0920 . 
4.  International Organization for Standardization/International Electrotechnical 
Commission, “ ISO/IEC 17000:2004  Conformity Assessment --Vocabulary and General 
Principles .”  Copies are available from the International Organizati on for Standardization, 
1, rue de Varembe, Case postale 56, CH -1211 Geneve 20, Switzerland, or on the Internet 
at http://www.iso.org/iso/catalogue_detail.htm?csnumber=29316  or may be examined at 
the Division of Dockets Management (see ADDRESSES) (Ref. Dock et No. FDA -2011 -
N-0146 and/or RIN 0910 -AG66).  
5.  International Organization for Standardization/International Electrotechnical 
Commission, ISO/IEC “17011:2004  Conformity As sessment --General Requirements  for 
Accreditation Bodies Accrediting Conformity Asse ssment Bodies .”  Copies are available 
from the International Organization for Standardization, 1, rue de Varembe, Case postale 
56, CH -1211 Geneve 20, Switzerland, or on the Internet at 
http://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csn umber=29332  280 
or may be examined at the Division of Dockets Management (see ADDRESSES) (Ref. 
Docket No. FDA -2011 -N-0146 and/or RIN 0910 -AG66).  
6.  International Organization for Standardization/International Electrotechnical 
Commission, “ ISO/IEC 17021:2011  Conformity As sessment --Requirements for Bodies 
Providing Audit and Certification of Management Systems .”  Copies are available from 
the International Organization for Standardization, 1, rue de Varembe, Case postale 56, 
CH-1211 Geneve 20, Switzerland, or on the Internet at 
http://www.iso.org/iso/home/store/publication_item.htm?pid=PUB100353  or may be 
examined at the Division of Dockets Management (see ADDRESSES) (Ref. Docket No. 
FDA -2011 -N-0146 and/or RIN 0910 -AG66).  
7.  International Organization for Stan dardization/International Electrotechnical 
Commission, “ ISO/IEC 17065:2012  Conformity Assessment --Requirements for Bodies 
Certifying Products, Processes and Services .”  Copies are available from the International 
Organization for Standardization, 1, rue de  Varembe, Case postale 56, CH -1211 Geneve 
20, Switzerland, or on the Internet at 
http://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=46568  
or may be examined at the Division of Dockets Management (see ADDRESSES) (Ref. 
Docket No. FD A-2011 -N-0146 and/or RIN 0910 -AG66).  
8.  International Organization for Standardization , ISO 19011:2011  Guidelines for 
Auditing Management Systems .”  Copies are available from the International 
Organization for Standardization, 1, rue de Varembe, Case post ale 56, CH -1211 Geneve 
20, Switzerland, or on the Internet at 
http://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=50675  281 
or may be examined at the Division of Dockets Management (see ADDRESSES) (Ref. 
Docket No. FDA -2011 -N-0146 and/o r RIN 0910 -AG66).  
9.  International Organization for Standardization/International Electrotechnical 
Commission, “ISO/IEC Guide 65:1996  General Requirements for Bodies Operating 
Product Certification Systems .”  Copies are available from the International Organization 
for Standardization, 1, rue de Varembe, Case postale 56, CH -1211 Geneve 20, 
Switzerland, or on the Internet at 
http://www.iso.org/iso/catalogue_detail.htm?csnumber=26796  or may be examined at the 
Division of Dockets Management (see ADDRESSES) (Ref. Docket No. FDA -2011 -N-
0146 and/or RIN 0910 -AG66).  
10. International Organization for Standardization/International Electrotechnical 
Commission, “ISO/IEC 17020:2012  Conformity Assessment --Requirements for  the 
Operation of Various Types of Bodies Performing Inspection .”  Copies are available 
from the International Organization for Standardization, 1, rue de Varembe, Case postale 
56, CH -1211 Geneve 20, Switzerland, or on the Internet at 
http://www.iso.org/is o/home/store/catalogue_tc/catalogue_detail.htm?csnumber=52994  
or may be examined at the Division of Dockets Management (see ADDRESSES) (Ref. 
Docket No. FDA -2011 -N-0146 and/or RIN 0910 -AG66).  
11. Global Food Safety Initiative, “ Enhancing Food Safety Through  Third -Party 
Certification ,” March 2011.  
12. International Organization for Standardization/International Electrotechnical 
Commission, “ ISO/IEC 17040:2005  Conformity Assessment --General Requirements for 
Peer Assessment of Conformity Assessment Bodies and Accreditation Bodies .”  Copies 282 
are available from the International Organization for Standardization, 1, rue de Varembe, 
Case postale 56, CH -1211 Geneve 20, Switzerland, or on the Internet at 
http://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail. htm?csnumber=31815  
or may be examined at the Division of Dockets Management (see ADDRESSES) (Ref. 
Docket No. FDA -2011 -N-0146 and/or RIN 0910 -AG66).  
13. International Accreditation Forum, “ IAF Endorsed Normative Documents , 
Issue 4 (IAF PR 4:2 007),” http://www.iaf.nu/upFiles/197878.IAF -PR4-
2007_Endorsed_NormDocs_Issue_4_Pub.pdf .  Accessed on October 26, 2015.  
14. Codex  Alimentarius Commission,  “Principles for Food Import and Export 
Inspection and Certification (CAC/GL 20 -1995 ).”  
http://www.codexalimentari us.org/input/download/standards/37/CXG_020e.pdf .  
Accessed on October 26, 2015.  
15. Armour, S., Lippert, J., and Smith, M., “Food Sickens Millions as Company -
Paid Checks Find It Safe,” Bloomberg Business , October 11, 2012 .  
http://www.bloomberg.com/news/ar ticles/2012 -10-11/food -sickens -millions -as-industry -
paid-inspectors -find-it-safe. Accessed on October 26, 2015.  
16. Zheng, Y., Muth, M.M., Kosa, K., “Economic Analysis of Third -Party Food 
Safety Certification of Imported Food,” RTI International, June 2012 . 
17. American National Standards Institute, “About ANSI ,” 
http://www.ansi.org/about_ansi/overview/overview.aspx?menuid=1 .   Accessed on May 
6, 2015.  
18. United Kingdom Accreditation Service, “About UKAS ,” 
http://www.ukas.com/about/ .  Accessed on October 26, 2015 . 283 
19. Danish Accreditation Fund , “DANAK Home” http://english.danak.dk/ .  
Accessed on May 4, 2015 . 
20. International Organization for Standards , “ISO/TS 22003:2007  Food Safety 
Management Systems --Requirements for Bodies Providing Audit and Certifica tion of 
Food Safety Management Systems .”  Copies are available from the International 
Organization for Standardization, 1, rue de Varembe, Case postale 56, CH -1211 Geneve 
20, Switzerland, or on the Internet at 
http://www.iso.org/iso/home/store/catalogue_tc /catalogue_detail.htm?csnumber=39834  
or may be examined at the Division of Dockets Management (see ADDRESSES) (Ref. 
Docket No. FDA -2011 -N-0146 and/or RIN 0910 -AG66) . 
21. International Organization for Standardization/International Electrotechnical 
Commissi on, “ ISO 22000:2005  Food Safety Ma nagement Systems --Requirements for 
Any Organization in the Food Chain .”  Copies are available from the International 
Organization for Standardization, 1, rue de Varembe, Case postale 56, CH -1211 Geneve 
20, Switzerland, or on the Internet at 
http://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=35466  
or may be examined at the Division of Dockets Management (see ADDRESSES) (Ref. 
Docket No. FDA -2011 -N-0146 and/or RIN 0910 -AG66) . 
22. British Retail Consortium, “ Global Standard for Food Safety , Issue 6,” 2012 .  
Copies are available from the British Retail Co nsortium, Second Floor, 21 Dart mouth 
Street, London SW1H 9BP, or may be examined at the Division of Dockets Management 
(see ADDRESSES) (Ref. Docke t No. FDA -2011 -N-0146 and/or RIN 0910 -AG66).  284 
23. Safe Quality Food Institute, “SQF  Code, Edition 7.2:  A HACCP -Based 
Supplier Assurance Code for the Food Industry ,” July 2014 .  https://www.sqfi.com/wp -
content/uploads/SQF -Code_Ed -7.2-July.pdf .  Accessed on October 27, 2015.  
24. International Organization for Standardization, “ ISO/TS 22003:2013  Food 
Safety Management Systems --Requirements for Bodies Providing Audit and Certification 
of Food Safety Management Systems .”  Copies are available from the Internatio nal 
Organization for Standardization, 1, rue de Varembe, Case postale 56, CH -1211 Geneve 
20, Switzerland, or on the Internet at 
http://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=60605  
or may be examined at the Division of Dockets  Management (see ADDRESSES) (Ref. 
Docket No. FDA -2011 -N-0146 and/or RIN 0910 -AG66) . 
25. FDA, “Tribal Summary Impact Statement:  Final Rule  on Accreditation of 
Third -Party Certification Bodies to Conduct Food Safety Audits and to Issue ,” Docket 
No. FDA -2011 -N-0146.  
List of Subjects  
21 CFR Part 1  
Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling, Reporting and 
recordkeeping requirements.  
21 CFR Part 11  
Administrative practice and procedure, Computer technology, Reporting and 
recordkeeping requirements.  
21 CFR Part 16  
Administrative practice and procedure.  285 
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority 
delegated to the Commissioner of Food and Drugs, 21 CFR parts 1, 11, and 16 are amended as 
follows:  
PART 1--GENERAL ENFORCEMENT REGULATIONS  
1. The authority citation for 21 CFR part 1 is revised to read as follows:   
Authority : 15 U.S.C. 1333, 1453, 1454, 1455 , 4402 ; 19 U.S.C. 1490, 1491; 21 U.S.C. 
321, 331, 332, 333, 334, 335a, 343, 350c, 350d, 350j, 352, 35 5, 360b, 360ccc, 360ccc -1, 360ccc -
2, 362, 371, 374, 381, 382, 384a, 384b, 384d, 387, 387a, 387c, 393; 42 U.S.C. 216, 241, 243, 
262, 264 , 271 .   
2. Add subpart M, consisting of §§  1.600 through 1.695, to read as follows:  
Subpart M --Accreditation of Third -Party Certification Bodies To Conduct Food Safety Audits 
and To Issue Certifications  
Sec. 
1.600 What definitions apply to this subpart?  
1.601 Who is subject to this subpart?  
Recognition of Accreditation Bodies Under This Subpart  
1.610 Who is eligible to seek  recognition?  
1.611 What legal authority must an accreditation body have to qualify for recognition?  
1.612 What competency and capacity must an accreditation body have to qualify for recognition?  
1.613 What protections against conflicts of interest must an  accreditation body have to qualify 
for recognition?  
1.614 What quality assurance procedures must an accreditation body have to qualify for 
recognition?  286 
1.615 What records procedures must an accreditation body have to qualify for recognition?  
Requirements for Accreditation Bodies That Have Been Recognized Under This Subpart  
1.620 How must a recognized accreditation body evaluate third -party certification bodies seeking 
accreditation?  
1.621 How must a recognized accreditation body monitor the performance of third -party 
certification bodies it accredited?  
1.622 How must a recognized accreditation body monitor its own performance?  
1.623 What reports and notifications must a recognized accreditation body submit to FDA?  
1.624 How must a recognized accreditation b ody protect against conflicts of interest?  
1.625 What records requirements must an accreditation body that has been recognized meet?  
Procedures for Recognition of Accreditation Bodies Under This Subpart  
1.630 How do I apply to FDA for recognition or renewal of recognition?  
1.631 How will FDA review my application for recognition or renewal of recognition and what 
happens once FDA decides on my application?  
1.632 What is the duration of recognition?  
1.633 How will FDA monitor recognized accreditation b odies?  
1.634 When will FDA revoke recognition?  
1.635 What if I want to voluntarily relinquish recognition or do not want to renew recognition?  
1.636 How do I request reinstatement of recognition?  
Accreditation of Third -Party Certification Bodies Under This  Subpart  
1.640 Who is eligible to seek accreditation?  
1.641 What legal authority must a third -party certification body have to qualify for accreditation?  287 
1.642 What competency and capacity must a third -party certification body have to qualify for 
accredita tion?  
1.643 What protections against conflicts of interest must a third -party certification body have to 
qualify for accreditation?  
1.644 What quality assurance procedures must a third -party certification body have to qualify for 
accreditation?  
1.645 What records procedures must a third -party certification body have to qualify for 
accreditation?  
Requirements for Third -Party Certification Bodies That Have Been Accredited Under This 
Subpart  
1.650 How must an accredited third -party  certification body ensure it s audit agents are 
competent and objective?  
1.651 How must an accredited third -party certification body conduct a food safety audit of an 
eligible entity?  
1.652 What must an accredited third -party certification body include in food safety audit reports?  
1.653 What must an accredited third -party certification body do when issuing food or facility 
certifications?  
1.654 When must an accredited third -party certification body monitor an eligible entity that it 
has issued a food or facility certification?  
1.655 H ow must an accredited third -party certification body monitor its own performance?  
1.656 What reports and notifications must an accredited third -party certification body submit?  
1.657 How must an accredited third -party certification body protect against con flicts of interest?  288 
1.658 What records requirements must a third -party certification body that has been accredited 
meet?  
Procedures for Accreditation of Third -Party Certification Bodies Under This Subpart  
1.660 Where do I apply for accreditation or renewal  of accreditation by a recognized 
accreditation body and what happens once the recognized accreditation body decides on my 
application?  
1.661 What is the duration of accreditation by a recognized accreditation body?  
1.662 How will FDA monitor accredited third -party certification bodies?  
1.663 How do I request an FDA waiver or waiver extension for the 13 -month limit for audit 
agents conducting regulatory audits?  
1.664 When would FDA withdraw accreditation?  
1.665 What if I want to voluntarily relinquish acc reditation or do not want to renew 
accreditation?  
1.666 How do I request reaccreditation?  
Additional Procedures for Direct Accreditation of Third -Party Certification Bodies Under This 
Subpart  
1.670 How do I apply to FDA for direct accreditation or renewal of direct accreditation?  
1.671 How will FDA review my application for direct accreditation or renewal of direct 
accreditation and what happens once FDA decides on my application?  
1.672 What is the duration of direct accreditation?  
Requirements for Eligible  Entities Under This Subpart  
1.680 How and when will FDA monitor eligible entities?  
1.681 How frequently must eligible entities be recertified?  289 
General Requirements of This Subpart  
1.690 How will FDA make information about recognized accreditation bodies a nd accredited 
third -party certification bodies available to the public?  
1.691 How do I request reconsideration of a denial by FDA of an application or a waiver 
request?  
1.692 How do I request internal agency review of a denial of an application or waiver r equest 
upon reconsideration?  
1.693 How do I request a regulatory hearing on a revocation of recognition or withdrawal of 
accreditation?  
1.694 Are electronic records created under this subpart subject to the electronic records 
requirements of part 11  of thi s chapter ? 
1.695 Are the records obtained by FDA under this subpart subject to public disclosure?  
Subpart M --Accreditation of Third -Party Certification Bodies To Conduct Food Safety Audits 
and To Issue Certifications   
§ 1.600 What definitions apply to this  subpart?  
(a) The FD&C Act  means the Federal Food, Drug, and Cosmetic Act.   
(b) Except as otherwise defined in paragraph (c) of this section, the definitions of terms in 
section 201 of the FD&C Act apply when the terms are used in this subpart.  
(c) In addition, for the purposes of this subpart:  
Accreditation  means a determination by a recognized accreditation body (or, in the case 
of direct accreditation, by FDA) that a third -party certification body meets the applicable 
requirements of this subpart.   290 
Accreditation body  means an authority that performs accreditation of third -party 
certification bodies.   
Accredited third -party certification body  means a third -party certification body that a 
recognized accreditation body (or, in the case of direct accred itation, FDA) has determined meets 
the applicable requirements of this subpart and is accredited to conduct food safety audits and to 
issue food or facility certifications to eligible entities.  An accredited third -party certification 
body has the same mea ning as accredited third -party auditor as defined in section 808(a)(4) of 
the FD&C Act.  
Assessment  means:  
(i) With respect to an accreditation body, an evaluation by FDA of the competency and 
capacity of the accreditation body under the applicable requirem ents of this subpart for the 
defined scope of recognition.  An assessment of the competency and capacity of the accreditation 
body involves evaluating the competency and capacity of the operations of the accreditation 
body that are relevant to decisions on  recognition and, if recognized, an evaluation of its 
performance and the validity of its accreditation decisions under the applicable requirements of 
this subpart.  
(ii) With respect to a third -party certification body, an evaluation by a recognized 
accred itation body (or, in the case of direct accreditation, FDA) of the competency and capacity 
of a third -party certification body under the applicable requirements of this subpart for the 
defined scope of accreditation.  An assessment of the competency and ca pacity of the third -party 
certification body involves evaluating the competency and capacity of the  operations of the 
third -party certification body that are relevant to decisions on accreditation and, if accredited, an 291 
evaluation of its performance and t he validity of its audit results and certification decisions under 
the applicable requirements of this subpart.  
Audit  means the systematic and functionally independent examination of an eligible 
entity under this subpart by an accredited third -party certif ication body or by FDA.  An audit 
conducted under this subpart is not considered an inspection under section 704 of the FD&C Act.  
Audit agent  means an individual who is an employee or other agent of an accredited 
third -party certification body who, althou gh not individually accredited, is qualified to conduct 
food safety audits on behalf of an accredited third -party certification body.  An audit agent 
includes a contractor of the accredited third -party certification body but excludes subcontractors 
or othe r agents under outsourcing arrangements for conducting food safety audits without direct 
control by the accredited third -party certification body.  
Consultative audit  means an audit of an eligible entity:  
(i) To determine whether such entity is in complianc e with the applicable food safety 
requirements of the FD&C Act, FDA regulations, and industry standards and practices;  
(ii) The results of which are for internal purposes only; and  
(iii) That is conducted in preparation for a regulatory audit; only the res ults of a 
regulatory audit may form the basis for issuance of a food or facility certification under this 
subpart.  
Direct accreditation  means accreditation of a third -party certification body by FDA.   
Eligible entity  means a foreign entity in the import s upply chain of food for consumption 
in the United States that chooses to be subject to a food safety audit under this subpart conducted 
by an accredited third -party certification body.  Eligible entities include foreign facilities 
required to be registered  under subpart H of this part.  292 
Facility  means any structure, or structures of an eligible entity under one ownership at 
one general physical location, or, in the case of a mobile facility, traveling to multiple locations, 
that manufactures/processes, packs , holds, grows, harvests, or raises animals for food for 
consumption in the United States. Transport vehicles are not facilities if they hold food only in 
the usual course of business as carriers. A facility may consist of one or more contiguous 
structures , and a single building may house more than one distinct facility if the facilities are 
under separate ownership. The private residence of an individual is not a facility. Non -bottled 
water drinking water collection and distribution establishments and thei r structures are not 
facilities.  Facilities for the purposes of this subpart are not limited to facilities required to be 
registered under subpart H of this part.   
Facility certification  means an attestation, issued for purposes of section 801(q) or 806 o f 
the FD&C Act by an accredited third -party certification body, after conducting a regulatory audit 
and any other activities necessary to establish whether a facility complies with the applicable 
food safety requirements of the FD&C Act and FDA regulations .  
Food  has the meaning given in section 201(f) of the FD&C Act, except that food does not 
include pesticides (as defined in 7 U.S.C. 136(u)).  
Food certification  means an attestation, issued for purposes of section 801(q) of the 
FD&C Act by an accredited third -party certification body, after conducting a regulatory audit 
and any other activities necessary to establish whether a food of an eligible entity complies with 
the applicable food safety requirements of the FD&C Act and FDA regulations.   
Food safet y audit  means a regulatory audit or a consultative audit that is conducted to 
determine compliance with the applicable food safety requirements of the FD&C Act, FDA 
regulations, and for consultative audits, also includes conformance with industry standards  and 293 
practices.  An eligible entity must declare that an audit is to be conducted as a regulatory audit or 
consultative audit at the time of audit planning and the audit will be conducted on an 
unannounced basis under this subpart.   
Foreign cooperative  means an autonomous association of persons, identified as members, 
who are united  through a jointly owned enterprise to aggregate food from member growers or 
processors that is intended for export to the United States.  
Recognized accreditation body  means an accreditation body that FDA has determined 
meets the applicable requirements of this subpart and is authorized to accredit third -party 
certification bodies under this subpart.  
Regulatory audit  means an audit of an eligible entity:  
(i) To determi ne whether such entity is in compliance with the applicable food safety 
requirements of the FD&C Act and FDA regulations; and  
(ii) The results of which are used in determining eligibility for certification under section 
801(q) or under section 806 of the F D&C Act.  
Relinquishment  means:  
(i) With respect to an accreditation body, a decision to cede voluntarily its authority to 
accredit third -party certification bodies as a recognized accreditation body prior to expiration of 
its recognition under this subpart ; and  
(ii) With respect to a third -party certification body, a decision to cede voluntarily its 
authority to conduct food safety audits and to issue food and facility certifications to eligible 
entities as an accredited third -party certification body prior  to expiration of its accreditation 
under this subpart.  294 
Self-assessment  means an evaluation conducted by a recognized accreditation body or by 
an accredited third -party certification body of its competency and capacity under the applicable 
requirements of this subpart for the defined scope of recognition or accreditation.  For 
recognized accreditation bodies this involves evaluating the competency and capacity of the 
entire operations of the accreditation body and the validity of its accreditation decisions  under 
the applicable requirements of this subpart.  For accredited third -party certification bodies this 
involves evaluating the competency and capacity of the entire operations of the third -party 
certification body and the validity of its audit results u nder the applicable requirements of this 
subpart.   
Third -party certification  body  has the same meaning as third -party auditor as that term is 
defined in section 808(a)(3) of the FD& C Act and means a foreign government, agency of a 
foreign government, foreign cooperative, or any other third party that is eligible to be considered 
for accreditation to conduct food safety audits and to certify that eligible entities meet the 
applicable food safety requirements of the FD&C Act and FDA regulations.  A third -party 
certification body may be a single individual or an organization.  Once accredited, a third -party 
certification body may use audit agents to conduct food safety audits.  
§ 1.601 W ho is subject to this subpart?  
(a)  Accreditation bodies .  Any accreditation body seeking recognition from FDA to 
accredit third -party certification bodies to conduct food safety audits and to issue food and 
facility certifications under this subpart.  
(b)  Third -party certification bodies .  Any third -party certification body seeking 
accreditation from a recognized accreditation body or direct accreditation by FDA for:  
(1) Conducting food safety audits; and  295 
(2) Issuing certifications that may be used in sat isfying a condition of admissibility of an 
article of food under section 801(q) of the FD&C Act; or issuing a facility certification for 
meeting the eligibility requirements for the Voluntary Qualified Importer Program under section 
806 of the FD&C Act.  
(c)  Eligible entities .  Any eligible entity seeking a food safety audit or a food or facility 
certification from an accredited third -party certification body under this subpart.  
(d)  Limited exemptions from section 801(q) of the FD&C Act --(1)  Alcoholic bev erages . 
(i) Any certification required under section 801(q) of the FD&C Act does not apply with respect 
to alcoholic beverages from an eligible entity that is a facility that meets the following two 
conditions:  
(A)  Under the Federal Alcohol Administration  Act (27 U.S.C. 201 et seq .) or chapter 51 
of subtitle E of the Internal Revenue Code of 1986 (26 U.S.C. 5001 et seq .), the facility is a 
foreign facility of a type that, if it were a domestic facility, would require obtaining a permit 
from, registering wi th, or obtaining approval of a notice or application from the Secretary of the 
Treasury as a condition of doing business in the United States; and  
(B)  Under section 415 of the FD&C Act, the facility is required to register as a facility 
because it is enga ged in manufacturing/processing one or more alcoholic beverages.  
(ii)  Any certification required under section 801(q) of the FD&C Act does not apply with 
respect to food that is not an alcoholic beverage  that is received and distributed by a facility 
described in paragraph (d)(1)(i) of this section, provided such food:  
(A)  Is received and distributed in prepackaged form that prevents any direct human 
contact with such food; and  296 
(B)  Constitutes not more than 5 percent of the overall sales of the facility,  as determined 
by the Secretary of the Treasury.  
(iii) Any certification required under section 801(q) of the FD&C Act does not apply with 
respect to raw materials or other ingredients that are imported for use in alcoholic beverages 
provided that:  
(A)  Th e imported raw materials or other ingredients are used in the 
manufacturing/processing, packing, or holding of alcoholic beverages;  
(B)  Such manufacturing/processing, packing, or holding is performed by the importer;  
(C)  The importer is required to regi ster under section 415 of the Federal Food, Drug, and 
Cosmetic Act; and  
(D)  The importer is exempt from the regulations in part 117 of this chapter in accordance 
with § 117.5(i).  
(2) Certain meat, poultry, and egg products .  Any certification required under section 
801(q) of the FD&C Act does not apply with respect to:  
(i)  Meat food products that at the time of importation are subject to the requirements of 
the United States Department of Agriculture (USDA) under the Federal  Meat Inspection Act (21 
U.S.C. 601 et seq .);  
(ii)  Poultry  products  that at the time of importation are subject to the requirements of the 
USDA under the Poultry  Products  Inspection Act (21 U.S.C. 451 et seq .); and  
(iii)  Egg products that at the time o f importation are subject to the requirements of the 
USDA under the Egg Products Inspection Act (21 U.S.C. 1031 et seq .). 
Recognition of Accreditation Bodies Under This Subpart  
§ 1.610 Who is eligible to seek recognition?  297 
An accreditation body is eligible to seek recognition by FDA if it can demonstrate that it 
meets the requirements of §§  1.611 t hrough  1.615.  The accreditation body may use 
documentation of conformance with International Organization for Standardization/International 
Electrotechnical Commission  (ISO/IEC ) 17011:2004, supplemented as necessary, in meeting the 
applicable requirements of this subpart.  
§ 1.611 What legal authority must an accreditation body have to qualify for recognition ?  
(a) An accreditation body seeking recognition mus t demonstrate that it has the authority 
(as a governmental entity or as a legal entity with contractual rights) to perform assessments of a 
third -party certification body as are necessary to determine its capability to conduct audits and 
certify food facil ities and food, including authority to:  
(1) Review any relevant records;  
(2) Conduct onsite assessments of the performance of third -party certification bodies, 
such as by witnessing the performance of a representative sample of its agents (or, in the case  of 
a third -party certification body that is an individual, such individual) conducting a representative 
sample of audits;  
(3) Perform any reassessments or surveillance necessary to monitor compliance of 
accredited third -party certification bodies; and  
(4) Suspend, withdraw, or reduce the scope of accreditation for failure to comply with the 
requirements of accreditation.  
(b) An accreditation body seeking recognition must demonstrate that it is capable of 
exerting the authority (as a governmental entity or  as a legal entity with contractual rights) 
necessary to meet the applicable requirements of this subpart, if recognized.  298 
§ 1.612 What competency and capacity must an accreditation body have to qualify for 
recognition?   
An accreditation body seeking recogn ition must demonstrate that it has:  
(a) The resources required to adequately implement its accreditation program, including:  
(1) Adequate numbers of employees and other agents with relevant knowledge, skills, 
and experience to effectively evaluate the qual ifications of third -party certification bodies 
seeking accreditation and to effectively monitor the performance of accredited third -party 
certification bodies; and  
(2) Adequate financial resources for its operations; and  
(b)  The capability to meet the ap plicable assessment and monitoring requirements, the 
reporting and notification requirements, and the procedures of this subpart, if recognized.  
§ 1.613 What protections against conflicts of interest must an accreditation body have to qualify 
for recogniti on? 
An accreditation body must demonstrate that it has:  
(a)  Implemented written measures to protect against conflicts of interest between the 
accreditation body (and its officers, employees, and other agents involved in accreditation 
activities) and any t hird-party certification body (and its officers, employees, and other agents 
involved in auditing and certification activities) seeking accreditation from, or accredited by, 
such accreditation body; and  
(b)  The capability to meet the applicable conflict of interest requirements of this subpart, 
if recognized.  
§ 1.614 What quality assurance procedures must an accreditation body have to qualify for 
recognition?   299 
An accreditation body seeking recognition must demonstrate that it has:  
(a) Implemented a writte n program for monitoring and evaluating the performance of its 
officers, employees, and other agents and its accreditation program, including procedures to:  
(1)  Identify areas in its accreditation program or performance where deficiencies exist; 
and  
(2) Quickly execute corrective actions that effectively address deficiencies when 
identified; and  
(b) The capability to meet the applicable quality assurance requirements of this subpart, if 
recognized.   
§ 1.615 What records procedures must an accreditation body have to qualify for recognition?  
An accreditation body seeking recognition must demonstrate that it has:  
(a)  Implemented written procedures to establish, control, and retain records (including 
documents and data) for the period of time necessary to m eet its contractual and legal obligations 
pertaining to this subpart and to provide an adequate basis for evaluating its program and 
performance; and  
(b) The capability to meet the applicable reporting and notification requirements of this 
subpart, if reco gnized.    
Requirements for Accreditation Bodies That Have Been Recognized Under This Subpart  
§ 1.620 How must a recognized accreditation body evaluate third -party certification bodies 
seeking accreditation?  
(a)  Prior to accrediting a third -party certific ation body under this subpart, a recognized 
accreditation body must perform, at a minimum, the following:  300 
(1) In the case of a foreign government or an agency of a foreign government, such 
reviews and audits of the government’s or agency’s food safety prog rams, systems, and 
standards as are necessary to determine that it meets the eligibility requirements of §  1.640(b) . 
(2) In the case of a foreign cooperative or any other third -party seeking accreditation as a 
third -party certification body, such reviews a nd audits of the training and qualifications of agents 
conducting audits for such cooperative or other third party (or in the case of a third -party 
certification body that is an individual, such individual) and such reviews of internal systems and 
any othe r investigation of the cooperative or other third party necessary to determine that it 
meets the eligibility requirements of §  1.640(c) .  
(3) In conducting a review and audit under paragraph (a)(1) or (2) of this section, an 
observation of a representative  sample of onsite audits examining compliance with the applicable 
food safety requirements of the FD&C Act and FDA regulations as conducted by the third -party 
certification body or its agents (or, in the case of a third -party certification body that is an 
individual, such individual).  
(b) A recognized accreditation body must require a third -party certification body, as a 
condition of accreditation under this subpart, to comply with the reports and notification 
requirements of §§  1.652 and 1.656 and to agree  to submit to FDA, electronically and in English, 
any food or facility certifications it issues for purposes of sections 801(q) or 806 of the FD&C 
Act. 
(c) A recognized accreditation body must maintain records on any denial of accreditation 
(in whole or in  part) and on any withdrawal, suspension, or reduction in scope of accreditation of 
a third -party certification body under this subpart.  The records must include the name and 301 
contact information for the third -party certification body; the date of the acti on; the scope of 
accreditation denied, withdrawn, suspended, or reduced; and the basis for such action.   
(d)  A recognized accreditation body must notify any third -party certification body of an 
adverse decision associated with its accreditation under thi s subpart, including denial of 
accreditation or the withdrawal, suspension, or reduction in the scope of its accreditation.  The 
recognized accreditation body must establish and implement written procedures for receiving 
and addressing appeals from any thi rd-party certification body challenging such an adverse 
decision and for investigating and deciding on appeals in a fair and meaningful manner.  The 
appeals procedures must provide similar protections to those offered by FDA under §§  1.692 and 
1.693, and i nclude requirements to:  
(1) Make the appeals procedures publicly available;  
(2) Use competent persons, who may or may not be external to the recognized 
accreditation body, who are free from bias or prejudice and have not participated in the 
accreditation d ecision or be subordinate to a person who has participated in the accreditation 
decision to investigate and decide appeals;  
(3) Advise third -party certification bodies of the final decisions on their appeals; and  
(4) Maintain records under §  1.625 of appe als, final decisions on appeals, and the bases 
for such decisions.  
§ 1.621 How must a recognized accreditation body monitor the performance of third -party 
certification bodies it accredited?  
(a) A recognized accreditation body must annually conduct a comprehensive assessment 
of the performance of each third -party certification body it accredited under this subpart by 
reviewing the accredited third -party certification body’s self -assessments (i ncluding information 302 
on compliance with the conflict of interest requirements of §§  1.643 and 1.657); its regulatory 
audit reports and notifications submitted to FDA under §  1.656; and any other information 
reasonably available to the recognized accreditat ion body regarding the compliance history of 
eligible entities the accredited third -party certification body certified under this subpart; or that is 
otherwise relevant to a determination whether the accredited third -party certification body is in 
complian ce with this subpart.   
(b) No later than 1 year after the initial date of accreditation of the third -party 
certification body and every 2 years thereafter for duration of its accreditation under this subpart, 
a recognized accreditation body must conduct o nsite observations of a representative sample of 
regulatory audits performed by the third -party certification body (or its audit agents) (or, in the 
case of a third -party certification body that is an individual, such individual) accredited under 
this subp art and must visit the accredited third -party certification body’s headquarters (or other 
location that manages audit agents conducting food safety audits under this subpart, if different 
than its headquarters).  The recognized accreditation body will cons ider the results of such 
observations and visits in the annual assessment of the accredited third -party certification body 
required by paragraph (a) of this section.  
§ 1.622 How must a recognized accreditation body monitor its own performance?  
(a) A recogn ized accreditation body must annually, and as required under §  1.664(g), 
conduct a self -assessment that includes evaluation of compliance with this subpart, including:  
(1) The performance of its officers, employees, or other agents involved in accreditatio n 
activities and the degree of consistency in conducting accreditation activities;  303 
(2) The compliance of the recognized accreditation body and its officers, employees, and 
other agents involved in accreditation activities, with the conflict of interest req uirements of 
§ 1.624; and  
(3) If requested by FDA, any other aspects of its performance relevant to a determination 
whether the recognized accreditation body is in compliance with this subpart.  
(b) As a means to evaluate the recognized accreditation body’s  performance, the self -
assessment must include onsite observation of regulatory audits of a representative sample of 
third -party certification bodies it accredited under this subpart. In meeting this requirement, the 
recognized accreditation body may use t he results of onsite observations performed under § 
1.621(b).   
(c) Based on the evaluations conducted under paragraphs (a) and (b) of this section, the 
recognized accreditation body must:  
(1)  Identify any area(s) where deficiencies exist;  
(2) Quickly imp lement corrective action(s) that effectively address those deficiencies; 
and 
(3) Establish and maintain records of any such corrective action(s) under §  1.625.  
(d) The recognized accreditation body must prepare, and as required by §  1.623(b) 
submit, a writ ten report of the results of its self -assessment that includes the following elements.  
Documentation of conformance to ISO/IEC 17011:2004 may be used, supplemented as 
necessary, in meeting the requirements of this paragraph.  
(1) A description of any corre ctive actions taken under paragraph (c) of this section;  304 
(2) A statement disclosing the extent to which the recognized accreditation body, and its 
officers, employees, and other agents involved in accreditation activities, complied with the 
conflict of int erest requirements in §  1.624; and  
(3) A statement attesting to the extent to which the recognized accreditation body 
complied with applicable requirements of this subpart.   
§ 1.623 What reports and notifications must a recognized accreditation body subm it to FDA?  
(a) Reporting results of assessments of accredited third -party certification body 
performance .  A recognized accreditation body must submit to FDA electronically, in English, a 
report of the results of any assessment conducted under §  1.621, no later than 45 days after 
completing such assessment.  The report must include an up -to-date list of any a udit agents used 
by the accredited third -party certification body to conduct food safety audits under this subpart.  
(b) Reporting results of recognized accreditation body self -assessments .  A recognized 
accreditation body must submit to FDA electronically,  in English:  
(1) A report of the results of an annual self -assessment required under §  1.622, no later 
than 45 days after completing such self -assessment; and  
(2) For a recognized accreditation body subject to §  1.664(g)(1), a report of such self -
assessm ent to FDA within 60 days of the third -party certification body’s withdrawal. A 
recognized accreditation body may use a report prepared for conformance to ISO/IEC 
17011:2004, supplemented as necessary, in meeting the requirements this section.  
(c) Immediat e notification to FDA .  A recognized accreditation body must notify FDA 
electronically, in English, immediately upon:  
(1) Granting (including expanding the scope of) accreditation to a third -party certification 
body under this subpart, and include:  305 
(i) The  name, address, telephone number, and email address of the accredited third -party 
certification body;  
(ii) The name of one or more officers of the accredited third -party certification body;  
(iii) A list of the accredited third -party certification body’s audit agents; and  
(iv) The scope of accreditation, the date on which it was granted, and its expiration date.  
(2) Withdrawing, suspending, or reducing the scope of an accreditation under this 
subpart, and include:  
(i) The basis for such action; and  
(ii) An y additional changes to accreditation information previously submitted to FDA 
under paragraph (c)(1) of this section.  
(3) Determining that a third -party certification body it accredited failed to comply with 
§ 1.653 in issuing a food or facility certificat ion under this subpart, and include:  
(i) The basis for such determination; and  
(ii) Any changes to accreditation information previously submitted to FDA under 
paragraph (c)(1) of this section.  
(d) Other notification to FDA .  A recognized accreditation body  must notify FDA 
electronically, in English, within 30 days after:  
(1) Denying accreditation (in whole or in part) under this subpart and include:  
(i) The name, address, telephone number, and email address of the third -party 
certification body;  
(ii) The na me of one or more officers of the third -party certification body;  
(iii) The scope of accreditation requested; and  
(iv) The scope and basis for such denial.  306 
(2) Making any significant change that would affect the manner in which it complies with 
the appli cable requirements of this subpart and include:  
(i) A description of the change; and  
(ii) An explanation for the purpose of the change.  
§ 1.624 How must a recognized accreditation body protect against conflicts of interest?   
(a) A recognized accreditation  body must implement a written program to protect against 
conflicts of interest between the recognized accreditation body (and its officers, employees, and 
other agents involved in accreditation activities) and any third -party certification body (and its 
officers, employees, and other agents involved in auditing and certification activities) seeking 
accreditation from, or accredited by, such recognized accreditation body, including the 
following:  
(1)  Ensuring that the recognized accreditation body (and its  officers, employees, or other 
agents  involved in accreditation activities) does not own or have a financial interest in, manage, 
or otherwise control the third -party certification body (or any affiliate, parent, or subsidiary); and  
(2) Prohibiting officer s, employees , or other agents involved in accreditation activities of 
the recognized accreditation body from accepting any money, gift, gratuity, or item of value 
from the third -party certification body.  
(3) The items specified in paragraph (a)(2) of this section do not include:  
(i) Money representing payment of fees for accreditation services and reimbursement of 
direct costs associated with an onsite assessment of the third -party certification body; or  
(ii) Lunch of de minimis value provided during the co urse of an assessment and on the 
premises where the assessment is conducted, if necessary to facilitate the efficient conduct of the 
assessment.  307 
(b) A recognized accreditation body may accept the payment of fees for accreditation 
services and the reimburse ment of direct costs associated with assessment of a certification body 
only after the date on which the report of such assessment was completed or the date of which 
the accreditation was issued, whichever comes later.  Such payment is not considered a con flict 
of interest for purposes of paragraph (a) of this section.  
(c) The financial interests of the spouses and children younger than 18 years of age of a 
recognized accreditation body’s officers, employees , and other agents involved in accreditation 
activ ities will be considered the financial interests of such officers, employees , and other agents 
involved in accreditation activities.  
(d) A recognized accreditation body must maintain on its Web site an up -to-date list of 
the third -party certification bodie s it accredited under this subpart and must identify the duration 
and scope of each accreditation and the date(s) on which the accredited third -party certification 
body paid any fee or reimbursement associated with such accreditation. If the accreditation of a 
certification body is suspended, withdrawn, or reduced in scope, this list must also include the 
date of suspension, withdrawal, or reduction in scope and maintain that information for the 
duration of accreditation or until the suspension is lifted, t he certification body is reaccredited, or 
the scope of accreditation is reinstated, whichever comes first.  
§ 1.625 What records requirements must an accreditation body that has been recognized meet?  
(a) An accreditation body that has been recognized must maintain electronically for 5 
years records created while it is recognized (including documents and data) demonstrating its 
compliance with this subpart, including records relating to:  
(1) Applications for accreditation and renewal of accreditation under §  1.660;  308 
(2) Decisions to grant, deny, suspend, withdraw, or expand or reduce the scope of an 
accreditation;  
(3) Challenges to adverse accreditation decisions under §  1.620(c);  
(4) Its monitoring of accredited third -party certification bodies under §  1.621;  
(5) Self -assessments and corrective actions under §  1.622;  
(6) Regulatory audit reports, including any supporting information, that an accredited 
third -party certification body may have submitted;  
(7) Any reports or notifications to FDA under §  1.623, in cluding any supporting 
information; and   
(8) Records of fee payments and reimbursement of direct costs.  
(b) An accreditation body that has been recognized must make records required by 
paragraph (a) of this section available for inspection and copying pro mptly upon written request 
of an authorized FDA officer or employee at the place of business of the accreditation body or at 
a reasonably accessible location.  If the records required by paragraph (a) of this section are 
requested by FDA electronically, th e records must be submitted to FDA electronically not later 
than 10 business days after the date of the request. Additionally, if the requested records are 
maintained in a language other than English, the accreditation body must electronically submit 
an En glish translation within a reasonable time.  
(c) An accreditation body that has been recognized must not prevent or interfere with 
FDA’s access to its accredited third -party certification bodies and the accredited third -party 
certification body records requ ired by §  1.658.  
Procedures for Recognition of Accreditation Bodies Under This Subpart  
§ 1.630 How do I apply to FDA for recognition or renewal of recognition?  309 
(a) Applicant for recognition .  An accreditation body seeking recognition must submit an 
applica tion demonstrating that it meets the eligibility requirements in §  1.610.  
(b) Applicant for renewal of recognition .  An accreditation body seeking renewal of its 
accreditation must submit a renewal application demonstrating that it continues to meet the 
requirements of this subpart.  
(c) Submission .  Recognition and renewal applications and any documents provided as 
part of the application process must be submitted electronically, in English.  An applicant must 
provide any translation and interpretation serv ices needed by FDA during the processing of the 
application, including during onsite assessments of the applicant by FDA.  
(d) Signature .  Recognition and renewal applications must be signed in the manner 
designated by FDA, by an individual authorized to ac t on behalf of the applicant for purposes of 
seeking recognition or renewal of recognition.  
§ 1.631 How will FDA review my application for recognition or renewal of recognition and what 
happens once FDA decides on my application?  
(a) Review of recognition  or renewal application .  FDA will examine an accreditation 
body’s recognition or renewal application for completeness and notify the applicant of any 
deficiencies.  FDA will review an accreditation body’s recognition or renewal application on a 
first in, first out basis according to the date on which the completed application was submitted; 
however, FDA may prioritize the review of specific applications to meet the needs of the 
program.  
(b) Evaluation of recognition or renewal .  FDA will evaluate any completed recognition 
or renewal application to determine whether the applicant meets the applicable requirements of 
this subpart.  Such evaluation may include an onsite assessment of the accreditation body.  FDA 310 
will notify the applicant, in writing, rega rding whether the application has been approved or 
denied.  FDA may make such notification electronically. If FDA does not reach a final decision 
on a renewal application before an accreditation body's recognition terminates by expiration, 
FDA may extend s uch recognition for a specified period of time or until the Agency reaches a 
final decision on the renewal application.  
(c) Issuance of recognition . FDA will notify an applicant that its recognition or renewal 
application has been approved through issuance  of recognition that will list any limitations 
associated with the recognition.  
(d) Issuance of denial of recognition or renewal application . FDA will notify an applicant 
that its recognition or renewal application has been denied through issuance of a de nial of 
recognition or denial of a renewal application that will state the basis for such denial and provide 
the procedures for requesting reconsideration of the application under §  1.691.  
(e) Notice of records custodian after denial of an application for renewal of recognition . 
An applicant whose renewal application was denied must notify FDA electronically, in English, 
within 10 business days of the date of issuance of a denial of a renewal application, of the name 
and contact information of the custodian  who will maintain the records required by §  1.625(a) 
and make them available to FDA as required by §  1.625(b). The contact information for the 
custodian must include, at a minimum, an email address and the physical address where the 
records required by §1 .625(a) will be located.   
(f) Effect of denial of an application for renewal of recognition of an accreditation body 
on accredited third -party certification bodies .  (1) FDA will issue a notice of the denial of a 
recognition renewal to any third -party cer tification bodies accredited by the accreditation body 311 
whose renewal application was denied.    The third -party certification body’s accreditation will 
remain in effect so long as the third -party certification body:   
(i) No later than 60 days after FDA’s issuance of the notice of the denial of recognition 
renewal, conducts a self -assessment under §  1.655 and reports the results of the self -assessment 
to FDA under §  1.656(b); and  
(ii) No later than 1 year after issuance of the notice of  denial of recogniti on renewal  or 
the original date of the expiration of the accreditation, whichever comes first, becomes 
accredited by another recognized accreditation body or by FDA through direct accreditation.  
(2) FDA may withdraw the accreditation of a third -party cert ification body whenever 
FDA determines there is good cause for withdrawal of accreditation under §  1.664(c).  
(g) Effect of denial of an application for renewal of recognition of an accreditation body 
on food or facility certifications issued to eligible en tities .  A food or facility certification issued 
by a third -party certification body accredited by a recognized accreditation body prior to 
issuance of a denial of the  renewal application will remain in effect until the certification 
expires.  If FDA has reason to believe that a certification issued for purposes of section 801(q) or 
806 of the FD&C Act is not valid or reliable, FDA may refuse to consider the certification in 
determining the admissibility of the article of food for which the certification w as offered or in 
determining the importer’s eligibility for participation in the voluntary qualified importer 
program (VQIP).  
(h) Public notice of denial of an application for renewal of recognition of an accreditation 
body .  FDA will provide notice on the  Web site described in §  1.690 of the date of issuance of a 
denial of a renewal application and will describe the basis for the denial.  
§ 1.632 What is the duration of recognition?  312 
FDA may grant recognition of an accreditation body for a period not to exce ed 5 years 
from the date of recognition.   
§ 1.633 How will FDA monitor recognized accreditation bodies?  
(a) FDA will evaluate the performance of each recognized accreditation body to 
determine its compliance with the applicable requirements of this subpar t.  Such assessment must 
occur by at least 4 years after the date of recognition for a 5 -year recognition period, or by no 
later than the mid -term point for a recognition period of less than 5 years.  FDA may conduct 
additional assessments of a recognized accreditation body at any time.  
(b) An FDA assessment of a recognized accreditation body may include onsite 
assessments of a representative sample of third -party certification bodies the recognized 
accreditation body accredited and onsite audits of a repre sentative sample of eligible entities 
certified by such third -party certification bodies under this subpart.  These may be conducted at 
any time and, as FDA determines necessary or appropriate, may occur without the recognized 
accreditation body or, in the  case of an audit of an eligible entity, the accredited third -party 
certification body present.  
§ 1.634 When will FDA revoke recognition?  
(a) Grounds for revocation of recognition .  FDA will revoke the recognition of an 
accreditation body found not to be in compliance with the requirements of this subpart, including 
for any one or more of the following:  
(1) Refusal by the accreditation body to allow FDA to access records required by §  1.625, 
or to conduct an assessment or investigation of the accreditation  body or of a third -party 
certification body it accredited to ensure the accreditation body’s continued compliance with the 
requirements of this subpart.  313 
(2) Failure to take timely and necessary corrective action when:  
(i) The accreditation of a third -party certification body it accredited is withdrawn by FDA 
under §  1.664(a);  
(ii) A significant deficiency is identified through self -assessment under §  1.622, 
monitoring under §  1.621, or self -assessment by one or more of its accredited third -party 
certifica tion bodies under §  1.655; or  
(iii) Directed to do so by FDA to ensure compliance with this subpart.  
(3) A determination by FDA that the accreditation body has committed fraud or has 
submitted material false statements to the Agency.  
(4) A determination by  FDA that there is otherwise good cause for revocation, including:  
(i) Demonstrated bias or lack of objectivity when conducting activities under this subpart; 
or 
(ii) Failure to adequately support one or more decisions to grant accreditation under this 
subpart.   
(b) Records request associated with revocation .  To assist in determining whether 
revocation is warranted under paragraph (a) of this section, FDA may req uest records of the 
accreditation body required by §  1.625 or the records, required by §  1.658, of one or more of the 
third -party certification bodies it accredited under this subpart.   
(c) Issuance of revocation of recognition .  (1) FDA will notify an ac creditation body that 
its recognition has been revoked through issuance of a revocation that will state the grounds for 
revocation, the procedures for requesting a regulatory hearing under §  1.693 on the revocation, 
and the procedures for requesting reinst atement of recognition under §  1.636.   314 
(2) Within 10 business days of the date of issuance of the revocation, the accreditation 
body must notify FDA electronically, in English, of the name of the custodian who will maintain 
the records and make them avail able to FDA as required by §  1.625.  The contact information for 
the custodian must provide, at a minimum, an email address and the physical address where the 
records will be located.  
(d) Effect of revocation of recognition of an accreditation body on accr edited third -party 
certification bodies .  (1) FDA will issue a notice of the revocation of recognition to any 
accredited third -party certification body accredited by the accreditation body whose recognition 
was revoked.  The third -party certification body’ s accreditation will remain in effect if the third -
party certification body:   
(i) No later than 60 days after FDA’s issuance of the notice of revocation, conducts a 
self-assessment under §  1.655 and reports the results of the self -assessment to FDA under 
§ 1.656(b); and  
(ii) No later than 1 year after issuance of the notice of the revocation, or the original date 
of expiration of the accreditation, whichever comes first, becomes accredited by another 
recognized accreditation body or by FDA through direct a ccreditation.  
(2) FDA may withdraw the accreditation of a third -party certification body whenever 
FDA determines there is good cause for withdrawal of accreditation under §  1.664(c).  
(e) Effect of revocation of recognition of an accreditation body on food or facility 
certifications issued to eligible entities .  A food or facility certification issued by a third -party 
certification body accredited by a recognized accreditation body prior to issuance of the 
revocation of recognition will remain in effect unti l the certificate terminates by expiration.  If 
FDA has reason to believe that a certification issued for purposes of section 801(q) or 806 of the 315 
FD&C Act is not valid or reliable, FDA may refuse to consider the certification in determining 
the admissibil ity of the article of food for which the certification was offered or in determining 
the importer’s eligibility for participation in VQIP.  
(f) Public notice of revocation of recognition .  FDA will provide notice on the Web site 
described in §  1.690 of the issuance of the revocation of recognition of an accreditation body and 
will describe the basis for revocation.  
§ 1.635 What if I want to voluntarily relinquish recognition or do not want to renew recognition?  
(a) Notice to FDA of intent to relinquish or no t to renew recognition . A recognized 
accreditation body must notify FDA electronically, in English, at least 60 days before voluntarily 
relinquishing recognition or before allowing recognition to expire without seeking renewal.  The 
recognized accreditatio n body must provide the name and contact information of the custodian 
who will maintain the records required under §  1.625(a) after the date of relinquishment or the 
date recognition expires, as applicable, and make them available to FDA as required by 
§ 1.625(b).  The contact information for the custodian must include, at a minimum, an email 
address and the physical address where the records required by §  1.625(a) will be located.  
(b) Notice to accredited third -party certification bodies of intent to relin quish or not to 
renew recognition . No later than 15 business days after notifying FDA under paragraph (a) of 
this section, the recognized accreditation body must notify any currently accredited third -party 
certification body that it intends to relinquish r ecognition or to allow its recognition to expire, 
specifying the date on which relinquishment or expiration will occur.  The recognized 
accreditation body must establish and maintain records of such notification under §  1.625.  
(c)(1) Effect of voluntary r elinquishment or expiration of recognition on third -party 
certification bodies . The accreditation of a third -party certification body issued prior to the 316 
relinquishment or expiration of its accreditation body’s recognition will remain in effect, so long 
as the third -party certification body:   
(i) No later than 60 days after the date of relinquishment or the date of expiration of the 
recognition, conducts a self -assessment under §  1.655 and reports the results of the self -
assessment to FDA under §  1.656(b);  and 
(ii) No later than 1 year after the date of relinquishment or the date of expiration of 
recognition, or the original date of the expiration of the accreditation, whichever comes first, 
becomes accredited by another recognized accreditation body or by FDA through direct 
accreditation.  
(2) FDA may withdraw the accreditation of a third -party certification body whenever 
FDA determines there is good cause for withdrawal of accreditation under §  1.664(c).  
(d) Effect of voluntary relinquishment or expiration of recognition of an accreditation 
body on food or facility certifications issued to eligible entities .  A food or facility certification 
issued by a third -party certification body accredited by a recognized accreditation body prior to 
relinquishment or ex piration of its recognition will remain in effect until the certification expires.  
If FDA has reason to believe that a certification issued for purposes of section 801(q) or 806 of 
the FD&C Act is not valid or reliable, FDA may refuse to consider the cert ification in 
determining the admissibility of the article of food for which the certification was offered or in 
determining the importer’s eligibility for participation in VQIP.  
(e) Public notice of voluntary relinquishment or expiration of recognition .  FDA will 
provide notice on the Web site described in §  1.690 of the voluntary relinquishment or expiration 
of recognition of an accreditation body under this subpart.  
§ 1.636 How do I request reinstatement of recognition?  317 
(a) Application following revocati on.  An accreditation body that has had its recognition 
revoked may seek reinstatement by submitting a new application for recognition under §  1.630.  
The accreditation body must submit evidence that the grounds for revocation have been resolved, 
including  evidence addressing the cause or conditions that were the basis for revocation and 
identifying measures that have been implemented to help ensure that such cause(s) or 
condition(s) are unlikely to recur.  
(b) Application following relinquishment .  An accre ditation body that previously 
relinquished its recognition under §  1.635 may seek recognition by submitting a new application 
for recognition under §  1.630.  
Accreditation of Third -Party Certification Bodies Under This Subpart  
§ 1.640 Who is eligible to se ek accreditation?  
(a) A f oreign government, agency of a foreign government, foreign cooperative, or any 
other third party may seek accreditation from a recognized accreditation body (or, where direct 
accreditation is appropriate, FDA)  to conduct food safety audits and to issue food and facility 
certifications to eligible entities under this subpart. An accredited third -party certification body 
may use documentation of conformance with ISO/IEC 17021: 2011 or ISO/IEC 17065: 2012, 
supplem ented as necessary, in meeting the applicable requirements of this subpart.  
(b) A foreign government or an agency of a foreign government is eligible for 
accreditation if it can demonstrate that its food safety programs, systems, and standards meet the 
requirements of §§  1.641 t hrough  1.645.  
(c) A foreign cooperative or other third party is eligible for accreditation if it can 
demonstrate that the training and qualifications of its agents used to conduct audits (or, in the 318 
case of a third -party certificatio n body that is an individual, such individual) and its internal 
systems and standards meet the requirements of §§  1.641 t hrough  1.645.  
§ 1.641 What legal authority must a third -party certification body have to qualify for 
accreditation?  
(a) A third -party certification body seeking accreditation from a recognized accreditation 
body or from FDA must demonstrate that it has the authority (as a governmental entity or as a 
legal entity with contractual rights) to perform such examinations of facilities, their p rocess(es), 
and food(s) as are necessary to determine compliance with the applicable food safety 
requirements of the FD&C Act and FDA regulations, and conformance with applicable industry 
standards and practices and to issue certifications where appropriat e based on a review of the 
findings of such examinations.  This includes authority to:  
(1) Review any relevant records;  
(2) Conduct onsite audits of an eligible entity; and  
(3) Suspend or withdraw certification for failure to comply with applicable requir ements.  
(b) A third -party certification body seeking accreditation must demonstrate that it is 
capable of exerting the authority (as a governmental entity or as legal entity with contractual 
rights) necessary to meet the applicable requirements of accredit ation under this subpart if 
accredited.  
§ 1.642 What competency and capacity must a third -party certification body have to qualify for 
accreditation?   
A third -party certification body seeking accreditation must demonstrate that it has:  
(a) The resources ne cessary to fully implement its certification program, including:  319 
(1) Adequate numbers of employees and other agents with relevant knowledge, skills, 
and experience to effectively examine for compliance with applicable FDA food safety 
requirements of the FD &C Act and FDA regulations, conformance with applicable industry 
standards and practices, and issuance of  valid and reliable certifications; and  
(2) Adequate financial resources for its operations; and  
(b) The competency and capacity to meet the applicabl e requirements of this subpart, if 
accredited.  
§ 1.643 What protections against conflicts of interest must a third -party certification body have 
to qualify for accreditation?  
A third -party certification body must demonstrate that it has:  
(a) Implemented wr itten measures to protect against conflicts of interest between the 
third -party certification body (and its officers, employees, and other agents involved in auditing 
and certification activities) and clients seeking examinations or certification from, or audited or 
certified by, such third -party certification body; and  
(b) The capability to meet the conflict of interest requirements in §  1.657, if accredited.   
§ 1.644 What quality assurance procedures must a third -party certification body have to qualify  
for accreditation?   
A third -party certification body seeking accreditation must demonstrate that it has:  
(a) Implemented a written program for monitoring and evaluating the performance of its 
officers, employees, and other agents involved in auditing and certification activities, including 
procedures to:  
(1) Identify deficiencies in its auditing and certification program or performance; and  320 
(2) Quickly execute corrective actions that effectively address any identified deficiencies; 
and 
(b) The capability to meet the quality assurance requirements of §  1.655, if accredited.   
§ 1.645 What records procedures must a third -party certification body have to qualify for 
accreditation?  
A third -party certification body seeking accreditation must demonstrate that it: 
(a) Implemented written procedures to establish, control, and retain records (including 
documents and data) for a period of time necessary to meet its contractual and legal obligations 
and to provide an adequate basis for evaluating its program and per formance; and  
(b) Is capable of meeting the reporting, notification, and records requirements of this 
subpart, if accredited.  
Requirements for Third -Party Certification Bodies That Have Been Accredited Under This 
Subpart  
§ 1.650 How must an accredited third-party certification body ensure its audit agents are 
competent and objective?  
(a) An accredited third -party certification body that uses audit agents to conduct food 
safety audits must ensure that each such audit agent meets the following requirements wi th 
respect to the scope of its accreditation under this subpart. If the accredited third -party 
certification body is an individual, that individual is also subject to the following requirements, 
as applicable:  
(1) Has relevant knowledge and experience that  provides an adequate basis for the audit 
agent to evaluate compliance with applicable food safety requirements of the FD&C Act and 321 
FDA regulations and, for consultative audits, also includes conformance with applicable industry 
standards and practices;  
(2) Has been determined by the accredited third -party certification body, through 
observations of a representative sample of audits, to be competent to conduct food safety audits 
under this subpart relevant to the audits they will be assigned to perform;  
(3) Has completed annual food safety training that is relevant to activities conducted 
under this subpart;  
(4) Is in compliance with the conflict of interest requirements of §  1.657 and has no other 
conflicts of interest with the eligible entity to be audit ed that might impair the audit agent’s 
objectivity; and  
(5) Agrees to notify its accredited third -party certification body immediately upon 
discovering, during a food safety audit, any condition that could cause or contribute to a serious 
risk to the publi c health.  
(b) In assigning an audit agent to conduct a food safety audit at a particular eligible 
entity, an accredited third -party certification body must determine that the audit agent is qualified 
to conduct such audit under the criteria established in paragraph (a) of this section and based on 
the scope and purpose of the audit and the type of facility, its process(es), and food.   
(c) An accredited third -party certification body cannot use an audit agent to conduct a 
regulatory audit at an eligible ent ity if such audit agent conducted a consultative audit or 
regulatory audit for the same eligible entity in the preceding 13 months,  except that  such 
limitation may be waived if the accredited third -party certification body demonstrates to FDA, 
under §  1.663, there is insufficient access to audit agents in the country or region where the 322 
eligible entity is located. If the accredited third -party certification body is an individual, that 
individual is also subject to such limitations.  
§ 1.651 How must an accr edited third -party certification body conduct a food safety audit of an 
eligible entity?  
(a) Audit planning .  Before beginning to conduct a food safety audit under this subpart, 
an accredited third -party certification body must:  
(1)  Require the eligible e ntity seeking a food safety audit to:  
(i) Identify the scope and purpose of the food safety audit, including the facility, 
process(es), or food to be audited; whether the food safety audit is to be conducted as a 
consultative or regulatory audit subject to  the requirements of this subpart, and if a regulatory 
audit, the type(s) of certification(s) sought; and  
(ii) Provide a 30 -day operating schedule for such facility that includes information 
relevant to the scope and purpose of the audit; and  
(2) Determine  whether the requested audit is within its scope of accreditation.  
(b) Authority to audit .  In arranging a food safety audit with an eligible entity under this 
subpart, an accredited third -party certification body must ensure it has authority, whether 
contractual or otherwise, to:  
(1) Conduct an unannounced audit to determine whether the facility, process(es), and 
food of the eligible entity (within the scope of the audit) comply with the applicable food safety 
requirements of the FD&C Act and FDA regulatio ns and, for consultative audits, also includes 
conformance with applicable industry standards and practices;  
(2) Access any records and any area of the facility, process(es), and food of the eligible 
entity relevant to the scope and purpose of such audit;  323 
(3) When, for a regulatory audit, sampling and analysis is conducted, the accredited third -
party certification body must use a laboratory that is accredited in accordance with:  
(i) ISO/IEC 17025:2005; or  
(ii) Another laboratory accreditation standard that  provides at least a similar level of 
assurance in the validity and reliability of sampling methodologies, analytical methodologies, 
and analytical results.  
(4) Notify FDA immediately if, at any time during a food safety audit, the accredited 
third -party c ertification body (or its audit agent, where applicable) discovers a condition that 
could cause or contribute to a serious risk to the public health and provide information required 
by § 1.656(c);  
(5) Prepare reports of audits conducted under this subpart  as follows:  
(i) For consultative audits, prepare reports that contain the elements specified in 
§ 1.652(a) and maintain such records, subject to FDA access in accordance with section 414 of 
the FD&C Act; and  
(ii) For regulatory audits, prepare reports that contain the elements specified in §  1.652(b) 
and submit them to FDA and to its recognized accreditation body (where applicable) under 
§ 1.656(a); and  
(6) Allow FDA and the recognized accreditation body that accredited such third -party 
certification bo dy, if any, to observe any food safety audit conducted under this subpart for 
purposes of evaluating the accredited third -party certification body’s performance under 
§§ 1.621 and 1.662 or, where appropriate, the recognized accreditation body’s performance  
under §§  1.622 and 1.633.  324 
(c) Audit protocols .  An accredited third -party certification body (or its audit agent, 
where applicable) must conduct a food safety audit in a manner consistent with the identified 
scope and purpose of the audit and within the s cope of its accreditation.   
(1) With the exception of records review, which may be scheduled, the audit must be 
conducted without announcement during the 30 -day timeframe identified under paragraph 
(a)(1)(ii) of this section and must be focused on determi ning whether the facility, its process(es), 
and food are in compliance with applicable food safety requirements of the FD&C Act and FDA 
regulations, and, for consultative audits, also includes conformance with applicable industry 
standards and practices th at are within the scope of the audit.  
(2) The audit must include records review prior to the onsite examination; an onsite 
examination of the facility, its process(es), and the food that results from such process(es); and 
where appropriate or when required  by FDA, environmental or product sampling and analysis.  
When, for a regulatory audit, sampling and analysis is conducted, the accredited third -party 
certification body must use a laboratory that is accredited in accordance with paragraph (b)(3)  of 
this s ection .  The audit may include any other activities necessary to determine compliance with 
applicable food safety requirements of the FD&C Act and FDA regulations, and, for consultative 
audits, also includes conformance with applicable industry standards a nd practices.  
(3) The audit must be sufficiently rigorous to allow the accredited third -party certification 
body to determine whether the eligible entity is in compliance with the applicable food safety 
requirements of the FD&C Act and FDA regulations, and  for consultative audits, also includes 
conformance with applicable industry standards and practices, at the time of the audit; and for a 
regulatory audit, whether the eligible entity, given its food safety system and practices would be 
likely to remain in  compliance with the applicable food safety requirements of the FD&C Act 325 
and FDA regulations for the duration of any certification issued under this subpart.  An 
accredited third -party certification body (or its audit agent, where applicable) that identifi es a 
deficiency requiring corrective action may verify the effectiveness of a corrective action once 
implemented by the eligible entity but must not recommend or provide input to the eligible entity 
in identifying, selecting, or implementing the corrective  action.  
(4) Audit observations and other data and information from the examination, including 
information on corrective actions, must be documented and must be used to support the findings 
contained in the audit report required by §  1.652 and maintained a s a record under §  1.658.  
§ 1.652 What must an accredited third -party certification body include in food safety audit 
reports?  
(a) Consultative audits .  An accredited third -party certification body must prepare a 
report of a consultative audit not later t han 45 days after completing such audit and must provide 
a copy of such report to the eligible entity and must maintain such report under §  1.658, subject 
to FDA access in accordance with the requirements of section 414 of the FD&C Act.  A 
consultative aud it report must include:  
(1) The identity of the site or location where the consultative audit was conducted, 
including:  
(i) The name, address and the FDA Establishment Identifier of the facility subject to the 
consultative audit and a unique facility ident ifier, if designated by FDA; and  
(ii) Where applicable, the FDA registration number assigned to the facility under subpart 
H of this part;  326 
(2) The identity of the eligible entity, if different from the facility, including the name, 
address, the FDA Establi shment Identifier and unique facility identifier, if designated by FDA, 
and, where applicable, registration number under subpart H of this part;  
(3) The name(s) and telephone number(s) of the person(s) responsible for compliance 
with the applicable food sa fety requirements of the FD&C Act and FDA regulations  
(4) The dates and scope of the consultative audit;  
(5) The process(es) and food(s) observed during such consultative audit; and  
(6) Any deficiencies observed that relate to or may influence a determinat ion of 
compliance with the applicable food safety requirements of the FD&C Act and FDA regulations 
that require corrective action, the corrective action plan, and the date on which such corrective 
actions were completed.  Such consultative audit report mus t be maintained as a record under 
§ 1.658 and must be made available to FDA in accordance with section 414 of the FD&C Act.  
(b) Regulatory audits .  An accredited third -party certification body must, no later than 45 
days after completing a regulatory audit , prepare and submit electronically, in English, to FDA 
and to its recognized accreditation body (or, in the case of direct accreditation, only to FDA) and 
must provide to the eligible entity a report of such regulatory audit that includes the following 
information:  
(1) The identity of the site or location where the regulatory audit was conducted, 
including:  
(i) The name,  address, and FDA Establishment Identifier of the facility subject to the 
regulatory audit and a unique facility identifier, if designate d by FDA; and  
(ii) Where applicable, the FDA registration number assigned to the facility under subpart 
H of this part;  327 
(2) The identity of the eligible entity, if different from the facility, including the name, 
address, FDA Establishment Identifier, and  unique facility identifier, if designated by FDA, and, 
where applicable, registration number under subpart H of this part;  
(3) The dates and scope of the regulatory audit;  
(4) The process(es) and food(s) observed during such regulatory audit;  
(5) The name (s) and telephone number(s) of the person(s) responsible for the facility’s 
compliance with the applicable food safety requirements of the FD&C Act and FDA regulations;  
(6) Any deficiencies observed during the regulatory audit that present a reasonable 
probability that the use of or exposure to a violative product:  
(i)  Will cause serious adverse health consequences or death to humans and animals; or  
(ii) May cause temporary or medically reversible adverse health consequences or where 
the probability of serious adverse health consequences or death to humans or animals is remote;  
(7) The corrective action plan for addressing each deficiency identified under paragraph 
(b)(6) of this section, unless corrective action was implemented immediately and verified onsite 
by the accredited third -party certification body (or its audit agent, where applicable);  
(8) Whether any sampling and laboratory analysis (e.g., under a microbiological sampling 
plan) is performed in or used by the facility; and  
(9) Whether the eli gible entity has made significant changes to the facility, its 
process(es), or food products during the 2 years preceding the regulatory audit.  
(c) Submission of regulatory audit report .  An accredited third -party certification body 
must submit a completed  regulatory audit report as required by paragraph (b) of this section, 
regardless of whether the certification body issued a food or facility certification  to the eligible 
entity.  328 
(d) Notice and appeals of adverse regulatory audit results . An accredited t hird-party 
certification body must notify an eligible entity of a denial of certification and must establish and 
implement written procedures for receiving and addressing appeals from eligible entities 
challenging such adverse regulatory audit results and for investigating and deciding on appeals in 
a fair and meaningful manner.  The appeals procedures must provide similar protections to those 
offered by FDA under §§  1.692 and 1.693, including requirements to:  
(1) Make the appeals procedures publicly availa ble; 
(2) Use competent persons, who may or may not be external to the accredited third -party 
certification body, who are free from bias or prejudice and have not participated in the 
certification decision or be subordinate to a person who has participated in the certification 
decision, to investigate and decide appeals;  
(3) Advise the eligible entity of the final decision on its appeal; and  
(4) Maintain records under §  1.658 of the appeal, the final decision, and the basis for such 
decision.  
§ 1.653 What mu st an accredited third -party certification body do when issuing food or facility 
certifications?  
(a) Basis for issuance of a food or facility certification .  (1) Prior to issuing a food or 
facility certification to an eligible entity, an accredited third -party certification body (or, where 
applicable, an audit agent on its behalf) must complete a regu latory audit that meets the 
requirements of §  1.651 and any other activities that may be necessary to determine compliance 
with the applicable food safety requ irements of the FD&C Act and FDA regulations.  
(2) If, as a result of an observation during a regulatory audit, an eligible entity must 
implement a corrective action plan to address a deficiency, an accredited third -party certification 329 
body may not issue a food or facility certification to such entity until after the accredited third -
party certification body verifies that eligible entity has implemented the corrective action plan 
through methods that reliably verify the corrective action was taken and as a r esult the identified 
deficiency is unlikely to recur, except onsite verification is required for corrective actions 
required to address deficiencies that are the subject of a notification under § 1.656(c).  
 (3) An accredited third -party certification body  must consider each observation and the 
data and other information from a regulatory audit and other activities conducted under §  1.651 
to determine whether the entity was in compliance with the applicable food safety requirements 
of the FD&C Act and FDA r egulations at the time of the audit and whether the eligible entity, 
given its food safety system and practices, would be likely to remain in compliance for the 
duration of any certification issued under this subpart.  
(4) A sing le regulatory audit may resu lt in issuance of one or more food or facility 
certifications under this subpart, provided that the requirements of issuance are met as to each 
such certification.  
(5) Where an accredited third -party certification body uses an audit agent to conduct a 
regulatory audit of an eligible entity under this subpart, the accredited third -party certification 
body (and not the audit agent) must make the determination whether to issue a food or facility 
certification based on the results of such regulatory audit.   
(b) Issuance of a food or facility certification and submission to FDA . (1) Any food or 
facility certification issued under this subpart must be submitted to FDA electronically and in 
English.  The accredited third -party certification body may issue a food o r facility certification 
under this subpart for a term of up to 12 months.  
(2) A food or facility certification must contain, at a minimum, the following elements:  330 
(i) The name and address of the accredited third -party certification body and the scope 
and date of its accreditation under this subpart;  
(ii) The name, address, FDA Establishment Identifier, and unique facility identifier, if 
designated by FDA, of the eligible entity to which the food or facility certification was issued;  
(iii) The name, address , FDA Establishment Identifier, and unique facility identifier, if 
designated by FDA, of the facility where the regulatory audit was conducted, if different than the 
eligible entity;  
(iv) The scope and date(s) of the regulatory audit and the certification number;  
(v) The name of the audit agent(s) (where applicable) conducting the regulatory audit; 
and  
(vi) The scope of the food or facility certification, date of issuance, and date of 
expiration.  
(3) FDA may refuse to accept any certification for purposes  of section 801(q) or 806 of 
the FD&C Act, if FDA determines, that such food or facility certification is not valid or reliable 
because, for example:   
(i) The certification is offered in support of the admissibility of a food that was not within 
the scope of the certification;  
(ii)  The certification was issued by an accredited third -party certification body acting 
outside the scope of its accreditation  under this subpart; or  
(iii)  The certification was issued without reliable demonstration that the requirements of 
paragraph (a)  of this section  were met.  
§ 1.654 When must an accredited third -party certification body monitor an eligible entity that it 
has issued a food or facility certification?  331 
If an accredited third -party certification body has reason to believe that an eligible entity 
to which it issued a food or facility certification may no longer be in compliance with the 
applicable food safety requ irements of the FD&C Act and FDA regulations, the accredited third -
party certification body must conduct any monitoring (including an onsite audit) of such eligible 
entity necessary to determine whether the entity is in compliance with such requirements.  The 
accredited third -party certification body must immediately notify FDA, under §  1.656(d), if it 
withdraws or suspends a food or facility certification because it determines that the entity is no 
longer in compliance with the applicable food safety requi rements of the FD&C Act and FDA 
regulations.  The accredited third -party certification body must maintain records of such 
monitoring under §  1.658.  
§ 1.655 How must an accredited third -party certification body monitor its own performance?  
(a) An accredited  third -party certification body must annually, upon FDA request made 
for cause, or as required under §  1.631(f)(1)(i), § 1.634(d)(1)(i), or § 1.635(c)(1)(i), conduct a 
self-assessment that includes evaluation of compliance with this subpart, including:  
(1) The performance of its officers, employees, or other agents involved in auditing and 
certification activities, including the performance of  audit agents in examining facilities, 
process(es), and food using the applicable food safety requirements of the FD&C Act and FDA 
regulations;  
(2) The degree of consistency among its officers, employees, or other agents involved in 
auditing and certification activities, including evaluating whether its audit agents interpreted 
audit protocols in a consistent manner;  332 
(3) The compliance of the accredited third -party certification body and its officers, 
employees, and other agents involved in auditing and certification activities, with the conflict of 
interest requirements of §  1.657;  
(4) Actions taken in response to t he results of any assessments conducted by FDA or, 
where applicable, the recognized accreditation body under §  1.621; and  
(5) As requested by FDA, any other aspects of its performance relevant to a 
determination of whether the accredited third -party certif ication body is in compliance with this 
subpart.  
(b) As a means to assess its performance, the accredited third -party certification body 
may evaluate the compliance of one or more of eligible entities to which a food or facility 
certification was issued un der this subpart.  
(c) Based on the assessments and evaluations conducted under paragraphs (a) and (b) of 
this section, the accredited third -party certification body must:  
(1) Identify any deficiencies in complying with the requirements of this subpart;  
(2) Quickly implement corrective action(s) that effectively address the identified 
deficiencies; and  
(3) Under §  1.658, establish and maintain records of such corrective action(s).  
(d) The accredited third -party certification body must prepare a written repo rt of the 
results of its self -assessment that includes:  
(1) A description of any corrective action(s) taken under paragraph (c) of this section;   
(2) A statement disclosing the extent to which the accredited third -party certification 
body, and its office rs, employees, and other agents involved in auditing and certification 
activities, complied with the conflict of interest requirements in §  1.657; and  333 
(3) A statement attesting to the extent to which the accredited third -party certification 
body complied with the applicable requirements of this subpart.  
(e) An accredited third -party certification body may use a report, supplemented as 
necessary, on its conformance to ISO/IEC 17021: 2011 or ISO/IEC 17065: 2012 in meeting the 
requirements of this section.  
§ 1.656 What reports and notifications must an accredited third -party certification body submit?  
(a) Reporting results of regulatory audits . An accredited third -party certification body 
must submit a regulatory audit report, as described in §  1.652(b), electronically, in English, to 
FDA and to the recognized accreditation body that granted its accreditation (where applicable), 
no later than 45  days after completing such audit.   
(b) Reporting results of accredited third -party certification body self -assessments .  An 
accredited third -party certification body must submit the report of its annual self -assessment 
required by §  1.655 electronically to its recognized accreditation body (or, in the case of direct 
accreditation, electronically and in English, to FDA), within 45 days of the anniversary date of 
its accreditation under this subpart.  For an accredited third -party certification body subject  to an 
FDA request for cause, or §  1.631(f)(1)(i),  § 1.634(d)(1)(i), or  § 1.635(c)(1)(i), the report of its 
self-assessment must be submitted to FDA electronically, in English, within 60 days of the FDA 
request, denial of renewal, revocation, or relinquish ment of recognition of the accreditation body 
that granted its accreditation.  Such report must include an up -to-date list of any audit agents it 
uses to conduct audits under this subpart.  
(c) Notification to FDA of a serious risk to public health .  An acc redited third -party 
certification body must immediately notify FDA electronically, in English, if during a regulatory 
or consultative audit, any of its audit agents or the accredited third -party certification body itself 334 
discovers a condition that could ca use or contribute to a serious risk to the public health, 
providing the following information:  
(1) The name, physical address, and unique facility identifier, if designated by FDA, of 
the eligible entity subject to the audit, and, where applicable, the reg istration number under 
subpart H of this part;  
(2) The name, physical address, and unique facility identifier, if designated by FDA, of 
the facility where the condition was discovered (if different from that of the eligible entity) and, 
where applicable, t he registration number assigned to the facility under subpart H of this part; 
and 
(3) The condition for which notification is submitted.  
(d) Immediate notification to FDA of withdrawal or suspension of a food or facility 
certification .  An accredited third -party certification body must notify FDA electronically, in 
English, immediately upon withdrawing or suspending any food or facility certification of an 
eligible entity and the basis for such action.  
(e) Notification to its recognized accreditation body o r an eligible entity . (1) After 
notifying FDA under paragraph (c) of this section, an accredited third -party certification body 
must immediately notify the eligible entity of such condition and must immediately thereafter 
notify the recognized accreditatio n body that granted its accreditation, except for third -party 
certification bodies directly accredited by FDA.  Where feasible and reliable, the accredited 
third -party certification body may contemporaneously notify its recognized accreditation body 
and/or  the eligible entity when notifying FDA.  
(2) An accredited third -party certification body must notify its recognized accreditation 
body (or, in the case of direct accreditation, FDA) electronically, in English, within 30 days after 335 
making any significant c hange that would affect the manner in which it complies with the 
requirements of this subpart and must include with such notification the following information:  
(i) A description of the change; and  
(ii) An explanation for the purpose of the change.  
§ 1.657 How must an accredited third -party certification body protect against conflicts of 
interest?  
(a) An accredited third -party certification body must implement a written program to 
protect against conflicts of interest between the accredited third -party cer tification body (and its 
officers, employees, and other agents involved in auditing and certification activities) and an 
eligible entity seeking a food safety audit or food or facility certification from, or audited or 
certified by, such accredited third -party certification body, including the following:  
(1) Ensuring that the accredited third -party certification body and its officers, employees, 
or other agents involved in auditing and certification activities do not own, operate, have a 
financial interest in, manage, or otherwise control an eligible entity to be certified, or any 
affiliate, parent, or subsidiary of the entity;  
(2) Ensuring that the accredited third -party certification body  and, its officers, employees, 
or other agents involved in auditing a nd certification activities are not owned, managed, or 
controlled by any person that owns or operates an eligible entity to be certified;  
(3) Ensuring that an audit agent of the accredited third -party certification body does not 
own, operate, have a finan cial interest in, manage, or otherwise control an eligible entity or any 
affiliate, parent, or subsidiary of the entity that is subject to a consultative or regulatory audit by 
the audit agent; and  336 
(4) Prohibiting an accredited third -party certification b ody’s officer, employee, or other 
agent involved in auditing and certification activities from accepting any money, gift, gratuity, or 
other item of value from the eligible entity to be audited or certified under this subpart.  
(5) The items specified in pa ragraph (a)(4) of this section do not include:  
(i) Money representing payment of fees for auditing and certification services and 
reimbursement of direct costs associated with an onsite audit by the third -party certification 
body; or  
(ii) Lunch of de minim is value provided during the course of an audit and on the premises 
where the audit is conducted, if necessary to facilitate the efficient conduct of the audit.  
(b) An accredited third -party certification body may accept the payment of fees for 
auditing an d certification services and the reimbursement of direct costs associated with an audit 
of an eligible entity only after the date on which the report of such audit was completed or the 
date a food or facility certification was issued, whichever is later.  Such payment is not 
considered a conflict of interest for purposes of paragraph (a) of this section.  
(c)  The financial interests of the spouses and children younger than 18 years of age of 
accredited third -party certification body’s officers, employees, a nd other agents involved in 
auditing and certification activities will be considered the financial interests of such officers, 
employees , and other agents involved in auditing and certification activities.  
(d) An accredited third -party certification body m ust maintain on its Web site an up -to-
date list of the eligible entities to which it has issued food or facility certifications under this 
subpart.  For each such eligible entity, the Web site also must identify the duration and scope of 
the food or facili ty certification and date(s) on which the eligible entity paid the accredited third -
party certification body any fee or reimbursement associated with such audit or certification.  337 
§ 1.658 What records requirements must a third -party certification body that has been accredited 
meet?  
(a) A third -party certification body that has been accredited must maintain electronically 
for 4 years records created during its period of accreditation (including documents and data) that 
document compliance with this subpart, i ncluding:  
(1) Any audit report and other documents resulting from a consultative audit conducted 
under this subpart, including the audit agent’s observations, correspondence with the eligible 
entity, verification of any corrective action(s) taken to addres s deficiencies identified during the 
audit;  
(2) Any request for a regulatory audit from an eligible entity;  
(3) Any audit report and other documents resulting from a regulatory audit conducted 
under this subpart, including the audit agent’s observations, correspondence with the eligible 
entity, verification of any corrective action(s) taken to address deficiencies identified during the 
audit, and, w hen sampling and analysis is conducted, laboratory testing records and results from 
a laboratory that is accr edited in accordance with §  1.651(b)(3), and documentation 
demonstrating such laboratory is accredited in accordance with §  1.651(b)(3);  
(4) Any notification submitted by an audit agent to the accredited third -party certification 
body in accordance with §  1.650(a)(5);  
(5) Any challenge to an adverse regulatory audit decision and the disposition of the 
challenge;  
(6) Any monitoring it conducted of an eligible entity to which food or facility 
certification was issued;  338 
(7) Its self -assessments and corrective actions taken to address any deficiencies identified 
during a self -assessment; and  
(8) Significant changes to its auditing or certification program that might affect 
compliance with this subpart.  
(b) An accredited third -party certification body must make t he records of a consultative 
audit required by paragraph (a)(1) of this section available to FDA in accordance with section 
414 of the FD&C Act.  
(c) An accredited third -party certification body must make the records required by 
paragraphs (a)(2) t hrough  (8) of this section available for inspection and copying promptly upon 
written request of an authorized FDA officer or employee at the place of business of the 
accredited third -party certification body or at a reasonably accessible location.  If such records  
are requested by FDA electronically, the records must be submitted electronically not later than 
10 business days after the date of the request. Additionally, if the records are maintained in a 
language other than English, an accredited third -party certif ication body must electronically 
submit an English translation within a reasonable time.  
Procedures for Accreditation of Third -Party Certification Bodies Under This Subpart  
§ 1.660 Where do I apply for accreditation or renewal of accreditation by a recogni zed 
accreditation body and what happens once the recognized accreditation body decides on my 
application?  
(a)  Submission of accreditation or renewal application to a recognized accreditation 
body .  A third -party certification body seeking accreditation m ust submit its request for 
accreditation or renewal of accreditation by a recognized accreditation body identified on the 
Web site described in §  1.690.  339 
(b) Notice of records custodian after denial of application for renewal of accreditation . 
An applicant whose renewal application was denied by a recognized accreditation body must 
notify FDA electronically, in English, within 10 business days of the date of issuance of a denial 
of accreditation or denial of the renewal application, of the name and contact i nformation of the 
custodian who will maintain the records required by §  1.658(a) and make them available to FDA 
as required by §  1.658(b) and (c).  The contact information for the custodian must include, at a 
minimum, an email address and the physical addr ess where the records required by §  1.658(a) 
will be located.  
(c) Effect of denial of an application for renewal of accreditation on food or facility 
certifications issued to eligible entities .  A food or facility certification issued by an accredited 
third-party certification body prior to issuance of the denial of its renewal application l will 
remain in effect until the certification expires.  If FDA has reason to believe that a certification 
issued for purposes of section 801(q) or 806 of the FD&C Act i s not valid or reliable, FDA may 
refuse to consider the certification in determining the admissibility of the article of food for 
which the certification was offered or in determining the importer’s eligibility for participation in 
VQIP.  
(d) Public notice of denial of an application for renewal of accreditation .  FDA will 
provide notice on the Web site described in §  1.690 of the date of issuance of a denial of renewal 
of accreditation of a third -party certification body that had previous been accredited.  
§ 1.661 What is the duration of accreditation by a recognized accreditation body?  
A recognized accreditation body may grant accreditation to a third -party certification 
body under this subpart for a period not to exceed 4 years.  
§ 1.662 How will FDA monitor  accredited third -party certification bodies?  340 
(a) FDA will periodically evaluate the performance of each accredited third -party 
certification body to determine whether the accredited third -party certification body continues to 
comply with the applicable re quirements of this subpart and whether there are deficiencies in the 
performance of the accredited third -party certification body that, if not corrected, would warrant 
withdrawal of its accreditation under §  1.664.  FDA will evaluate each directly accredit ed third -
party certification body annually.  For a third -party certification body accredited by a recognized 
accreditation body, FDA will evaluate an accredited third -party certification body not later than 3 
years after the date of accreditation for a 4 -year term of accreditation, or by no later than the 
mid-term point for accreditation granted for less than 4 years.  FDA may conduct additional 
performance assessments of an accredited third -party certification body at any time.  
(b) In evaluating the perfor mance of an accredited third -party certification body under 
paragraph (a) of this section, FDA may review any one or more of the following:  
(1) Regulatory audit reports and food and facility certifications;  
(2) The accredited third -party certification body ’s self -assessments under §  1.655;  
(3) Reports of assessments by a recognized accreditation body under §  1.621;  
(4) Documents and other information relevant to a determination of the accredited third -
party certification body’s compliance with the applicabl e requirements of this subpart; and  
(5) Information obtained by FDA, including during inspections, audits, onsite 
observations, or investigations, of one or more eligible entities to which a food or facility 
certification was issued by such accredited thir d-party certification body.   
(c) FDA may conduct its evaluation of an accredited third -party certification body 
through a site visit to an accredited third -party certification body’s headquarters (or other 
location that manages audit agents conducting food safety audits under this subpart, if different 341 
than its headquarters), through onsite observation of an accredited third party certification body’s 
performance during a food safety audit of an eligible entity, or through document review.  
§ 1.663 How d o I request an FDA waiver or waiver extension for the 13 -month limit for audit 
agents conducting regulatory audits?  
(a) An accredited third -party certification body may submit a request to FDA to waive the 
requirements of §  1.650(c) preventing an audit age nt from conducting a regulatory audit of an 
eligible entity if the audit agent (or, in the case that the third -party certification body is an 
individual, the third -party certification body) has conducted a food safety audit of such entity 
during the previo us 13 months.  The accredited third -party certification body seeking a waiver or 
waiver extension must demonstrate there is insufficient access to audit agents and any third -party 
certification bodies that are comprised of an individual in the country or r egion where the 
eligible entity is located.   
(b) Requests for a waiver or waiver extension and all documents provided in support of 
the request must be submitted to FDA electronically, in English.  The requestor must provide 
such translation and interpret ation services as are needed by FDA to process the request.  
(c) The request must be signed by the requestor or by any individual authorized to act on 
behalf of the requestor for purposes of seeking such waiver or waiver extension.  
(d) FDA will review requ ests for waivers and waiver extensions on a first in, first out 
basis according to the date on which the completed submission is received; however, FDA may 
prioritize the review of specific requests to meet the needs of the program.  FDA will evaluate 
any completed waiver request to determine whether the criteria for waiver have been met.   
(e) FDA will notify the requestor whether the request for a waiver or waiver extension is 
approved or denied.  342 
(f) If FDA approves the request, issuance of the waiver wil l state the duration of the 
waiver and list any limitations associated with it.  If FDA denies the request, the issuance of a 
denial of a waiver request will state the basis for denial and will provide the address and 
procedures for requesting reconsiderat ion of the request under §  1.691.  
(g) Unless FDA notifies a requestor that its waiver request has been approved, an 
accredited third -party certification body must not use the audit agent to conduct a regulatory 
audit of such eligible entity until the 13 -month limit in §  1.650(c) has elapsed.  
§ 1.664 When would FDA withdraw accreditation?  
(a) Mandatory withdrawal .  FDA will withdraw accreditation from a third -party 
certification body:  
(1) Except as provided in paragraph (b) of this section, if the food or fa cility certified 
under this subpart is linked to an outbreak of foodborne illness or chemical or physical hazard 
that has a reasonable probability of causing serious adverse health consequences or death in 
humans or animals;  
(2) Following an evaluation and  finding by FDA that the third -party certification body no 
longer complies with the applicable requirements of this subpart; or  
(3) Following its refusal to allow FDA to access records under §  1.658 or to conduct an 
audit, assessment, or investigation nece ssary to ensure continued compliance with this subpart.  
(b) Exception .  FDA may waive mandatory withdrawal under paragraph (a)(1) of this 
section, if FDA:  
(1) Conducts an investigation of the material facts related to the outbreak of human or 
animal illnes s;  343 
(2) Reviews the relevant audit records and the actions taken by the accredited third -party 
certification body in support of its decision to certify; and  
(3) Determines that the accredited third -party certification body satisfied the requirements 
for issuance of certification under this subpart.  
(c) Discretionary withdrawal .  FDA may withdraw accreditation, in whole or in part, 
from a third -party certification body when such third -party certification body is accredited by an 
accreditation body for which  recognition is revoked under §  1.634, if FDA determines there is 
good cause for withdrawal, including:  
(1) Demonstrated bias or lack of objectivity when conducting activities under this 
subpart; or  
(2) Performance that calls into question the validity or reliability of its food safety audits 
or certifications.  
(d) Records access .  FDA may request records of the accredited third -party certification 
body under §  1.658 and, where applicable, may request records under § 1.625 of an accreditation 
body that has  been recognized under §  1.625, when considering withdrawal under paragraph 
(a)(1), (a)(2), or (c) of this section.  
(e) Notice to the third -party certification body of withdrawal of accreditation .  (1) FDA 
will notify a third -party certification body of th e withdrawal of its accreditation through issuance 
of a withdrawal that will state the grounds for withdrawal, the procedures for requesting a 
regulatory hearing under §  1.693 on the withdrawal, and the procedures for requesting 
reaccreditation under §  1.666.   
(2) Within 10 business days of the date of issuance of the withdrawal, the third -party 
certification body must notify FDA electronically, in English, of the name of the custodian who 344 
will maintain the records required by §  1.658, and provide contact information for the custodian, 
which will at least include an email address, and the street address where the records will be 
located.  
(f) Effect of withdrawal of accreditation on eligible entities .  A food or facility 
certification issued by a third -party certification body prior to withdrawal will remain in effect 
until the certification terminates by expiration.  If FDA has reason to believe that a certification 
issued for purposes of section 801( q) or 806 of the FD&C Act is not valid or reliable, FDA may 
refuse to consider the certification in determining the admissibility of the article of food for 
which the certification was offered or in determining the importer’s eligibility for participation in 
VQIP.  
(g) Effect of withdrawal of accreditation on recognized accreditation bodies .  (1) FDA 
will notify a recognized accreditation body if the accreditation of a third -party certification body 
it accredited is withdrawn by FDA.  Such accreditation body ’s recognition will remain in effect 
if, no later than 60 days after withdrawal, the accreditation body conducts a self -assessment 
under §  1.622 and reports the results of the self -assessment to FDA as required by §  1.623(b).  
(2) FDA may revoke the recogni tion of an accreditation body whenever FDA determines 
there is good cause for revocation of recognition under §  1.634.  
(h) Public notice of withdrawal accreditation .  FDA will provide notice on the Web site 
described in §  1.690 of its withdrawal of accredi tation of a third -party certification body and 
provide a description of the basis for withdrawal.   
§ 1.665 What if I want to voluntarily relinquish accreditation or do not want to renew 
accreditation?  345 
(a) Notice to FDA of intent to relinquish or not to re new accreditation . A third -party 
certification body must notify FDA electronically, in English, at least 60 days before voluntarily 
relinquishing accreditation or before allowing accreditation to expire without seeking renewal.  
The certification body must  provide the name and contact information of the custodian who will 
maintain the records required under §  1.658(a) after the date of relinquishment or the date 
accreditation expires, as applicable, and make them available to FDA as required by §  1.658(b) 
and (c).  The contact information for the custodian must include, at a minimum, an email address 
and the physical address where the records required by §1.658(a) will be located.  
(b) Notice to recognized accreditation body and eligible entities of intent to  relinquish or 
not to renew accreditation . No later than 15 business days after notifying FDA under paragraph 
(a) of this section, the certification body must notify its recognized accreditation body and any 
eligible entity with current certifications that  it intends to relinquish accreditation or to allow its 
accreditation to expire, specifying the date on which relinquishment or expiration will occur. The 
recognized accreditation body must establish and maintain records of such notification under 
§ 1.625( a).  
(c) Effect of voluntary relinquishment or expiration of accreditation on food or facility 
certifications issued to eligible entities .  A food or facility certification issued by a third -party 
certification body prior to relinquishment or expiration of  its accreditation will remain in effect 
until the certification expires.  If FDA has reason to believe that a certification issued for 
purposes of section 801(q) or 806 of the FD&C Act is not valid or reliable, FDA may refuse to 
consider the certification  in determining the admissibility of the article of food for which the 
certification was offered or in determining the importer’s eligibility for participation in VQIP.  346 
(d) Public notice of voluntary relinquishment or expiration of accreditation .  FDA will  
provide notice on the Web site described in §  1.690 of the voluntary relinquishment or expiration 
of accreditation of a certification body under this subpart.  
§ 1.666 How do I request reaccreditation?  
(a) Application following withdrawal .  FDA will reinst ate the accreditation of a third -
party certification body for which it has withdrawn accreditation:  
(1) If, in the case of direct accreditation, FDA determines, based on evidence presented 
by the third -party certification body, that the third -party certifi cation body satisfies the applicable 
requirements of this subpart and adequate grounds for withdrawal no longer exist; or  
(2) In the case of a third -party certification body accredited by an accreditation body for 
which recognition has been revoked under §  1.634:  
(i) If the third -party certification body becomes accredited by another recognized 
accreditation body or by FDA through direct accreditation no later than 1 year after withdrawal 
of accreditation, or the original date of the expiration of accredita tion, whichever comes first; or  
(ii) Under such conditions as FDA may impose in withdrawing accreditation.  
(b) Application following voluntary relinquishment .  A third -party certification body that 
previously relinquished its accreditation under §  1.665 ma y seek accreditation by submitting a 
new application for accreditation under §  1.660 or, where applicable, §  1.670.  
Additional Procedures for Direct Accreditation of Third -Party Certification Bodies Under This 
Subpart  
§ 1.670 How do I apply to FDA for dire ct accreditation or renewal of direct accreditation?  
(a) Eligibility . (1) FDA will accept applications from third -party certification bodies for 
direct accreditation or renewal of direct accreditation only if FDA determines that it has not 347 
identified and recognized an accreditation body to meet the requirements of section 8 08 of the 
FD&C Act within 2 years after establishing the accredited third -party audits and certification 
program.  Such FDA determination may apply, as appropriate, to specific types of third -party 
certification bodies, types of expertise, or geographic lo cation; or through identification by FDA 
of any requirements of section 808 of the FD&C Act not otherwise met by previously recognized 
accreditation bodies.  FDA will only accept applications for direct accreditation and renewal 
applications that are withi n the scope of the determination.  
(2) FDA may revoke or modify a determination under paragraph (a)(1) of this section if 
FDA subsequently identifies and recognizes an accreditation body that affects such 
determination.  
(3) FDA will provide notice on the W eb site described in §  1.690 of a determination 
under paragraph (a)(1) of this section and of a revocation or modification of the determination 
under paragraph (a)(1) of this section, as described in paragraph (a)(2) of this section.  
(b) Application for di rect accreditation or renewal of direct accreditation .  (1) A third -
party certification body seeking direct accreditation or renewal of direct accreditation must 
submit an application to FDA, demonstrating that it is within the scope of the determination 
issued under paragraph (a)(1) of this section, and it meets the eligibility requirements of §  1.640.  
(2)  Applications and all documents provided as part of the application process must be 
submitted electronically, in English.  An applicant must provide suc h translation and 
interpretation services as are needed by FDA to process the application, including during an 
onsite audit of the applicant.   348 
(3)  The application must be signed in the manner designated by FDA by an individual 
authorized to act on behalf of the applicant for purposes of seeking or renewing direct 
accreditation.  
§ 1.671 How will FDA review my application for direct accreditation  or renewal of direct 
accreditation and what happens once FDA decides on my application?  
(a) Review of a direct accreditation or renewal application . FDA will examine a third -
party certification body’s direct accreditation or renewal application for comple teness and notify 
the applicant of any deficiencies.  FDA will review applications for direct accreditation and for 
renewal of direct accreditation on a first in, first out basis according to the date the completed 
submission is received; however, FDA may prioritize the review of specific applications to meet 
the needs of the program.  
(b) Evaluation of a direct accreditation or renewal application . FDA will evaluate any 
completed application to determine whether the applicant meets the requirements for dire ct 
accreditation under this subpart.  If FDA does not reach a final decision on a renewal application 
before the expiration of the direct accreditation, FDA may extend the duration of such direct 
accreditation for a specified period of time or until the Ag ency reaches a final decision on the 
renewal application.  
(c) Notice of approval or denial . FDA will notify the applicant that its direct accreditation 
or renewal application has been approved through issuance of or denied.  
(d) Issuance of direct accredita tion. If an application has been approved, the issuance of 
the direct accreditation that will list any limitations associated with the accreditation.  
(e) Issuance of denial of direct accreditation .  If FDA issues a denial of direct 
accreditation or denial of a renewal application, the issuance of the denial of direct accreditation 349 
will state the basis for such denial and provide the procedures for requesting reconsideration of 
the application under §  1.691.  
(f) Notice of records custodian after denial of ap plication for renewal of direct 
accreditation . An applicant whose renewal application was denied must notify FDA 
electronically, in English, within 10 business days of the date of issuance of a denial of a renewal 
application, of the name and contact infor mation of the custodian who will maintain the records 
required by §  1.658(a) and make them available to FDA as required by §  1.658(b) and (c). The 
contact information for the custodian must include, at a minimum, an email address and the 
physical address w here the records required by §1.658(b) will be located.   
(g) Effect of denial of renewal of direct accreditation on food or facility certifications 
issued to eligible entities .  A food or facility certification issued by an accredited third -party 
certific ation body prior to issuance of the denial of its renewal application will remain in effect 
until the certification expires.  If FDA has reason to believe that a certification issued for 
purposes of section 801(q) or 806 of the FD&C Act is not valid or rel iable, FDA may refuse to 
consider the certification in determining the admissibility of the article of food for which the 
certification was offered or in determining the importer’s eligibility for participation in VQIP.  
(h) Public notice of denial of renew al of direct accreditation .  FDA will provide notice on 
the Web site described in §  1.690 of the issuance of a denial of renewal application for direct 
accreditation under this subpart.  
§ 1.672 What is the duration of direct accreditation?  
FDA will grant d irect accreditation of a third -party certification body for a period not to 
exceed 4 years.  
Requirements for Eligible Entities Under This Subpart  350 
§ 1.680 How and when will FDA monitor eligible entities?   
FDA may, at any time, conduct an onsite audit of an  eligible entity that has received food 
or facility certification from an accredited third -party certification body under this subpart.  
Where FDA determines necessary or appropriate, the unannounced audit may be conducted with 
or without the accredited th ird-party certification body or the recognized accreditation body 
(where applicable) present.  An FDA audit conducted under this section will be conducted on an 
unannounced basis and may be preceded by a request for a 30 -day operating schedule.  
§ 1.681 How  frequently must eligible entities be recertified?  
An eligible entity seeking recertification of a food or facility certification under this 
subpart must apply for recertification prior to the expiration of its certification.  For certifications 
used in me eting the requirements of section 801(q) or 806 of the FD&C Act, FDA may require 
an eligible entity to apply for recertification at any time FDA determines appropriate under such 
section.  
General Requirements of This Subpart  
§ 1.690 How will FDA make info rmation about recognized accreditation bodies and accredited 
third -party certification bodies available to the public?  
FDA will place on its Web site a registry of recognized accreditation bodies and 
accredited third -party certification bodies, including the name, contact information, and scope 
and duration of recognition or accreditation.  The registry may provide information on third -
party certification bodies accredited by recognized accreditation bodies through links to the Web 
sites of such recognized  accreditation bodies. FDA will also place on its Web site a list of 
accreditation bodies for which it has denied renewal of recognition, for which FDA has revoked 
recognition, and that have relinquished their recognition or have allowed their recognition to 351 
expire. FDA will also place in its Web site a list of certification bodies whose renewal of 
accreditation has been denied, for which FDA has withdrawn accreditation, and that have 
relinquished their accreditations or have allowed their accreditations to  expire. FDA will place 
on its Web site determinations under §  1.670(a)(1) and modifications of such determinations 
under §  1.670(a)(2).  
§ 1.691 How do I request reconsideration of a denial by FDA of an application or a waiver 
request?  
(a) An accreditation  body may seek reconsideration of the denial of an application for 
recognition, renewal of recognition, or reinstatement of recognition no later than 10 business 
days after the date of the issuance of such denial.  
(b) A third -party certification body may s eek reconsideration of the denial of an 
application for direct accreditation, renewal of direct accreditation, reaccreditation of directly 
accredited third -party certification body, a request for a waiver of the conflict of interest 
requirement in §  1.650( b), or a waiver extension no later than 10 business days after the date of 
the issuance of such denial.  
(c) A request to reconsider an application or waiver request under paragraph (a) or (b) of 
this section must be signed by the requestor or by an individ ual authorized to act on its behalf in 
submitting the request for reconsideration.  The request must be submitted electronically in 
English and must comply with the procedures described in the notice.   
(d) After completing its review and evaluation of the  request for reconsideration, FDA 
will notify the requestor through the issuance of the recognition, direct accreditation, or waiver 
upon reconsideration or through the issuance of a denial of the application or waiver request 
under paragraph (a) or (b) of this section upon reconsideration.   352 
§ 1.692 How do I request internal agency review of a denial of an application or waiver request 
upon reconsideration?  
(a) No later than 10 business days after the date of issuance of a denial of an application 
or waive r request upon reconsideration under §  1.691, the requestor may seek internal agency 
review of such denial under §  10.75(c)(1) of this chapter.   
(b) The request for internal agency review under paragraph (a) of this section must be 
signed by the requestor  or by an individual authorized to act on its behalf in submitting the 
request for internal review.  The request must be submitted electronically in English to the 
address specified in the denial upon reconsideration and must comply with procedures it 
describes.   
(c) Under §  10.75(d) of this chapter, internal agency review of such denial must be based 
on the information in the administrative file, which will include any supporting information 
submitted under §  1.691(c).   
(d) After completing the review an d evaluation of the administrative file, FDA will notify 
the requestor of its decision to overturn the denial and grant the application or waiver request 
through issuance of an application or waiver request upon reconsideration or to affirm the denial 
of the application or waiver request upon reconsideration through issuance of a denial of an 
application or waiver request upon reconsideration.  
(e) Issuance by FDA of a denial of an application or waiver request upon reconsideration 
constitutes final agency a ction under 5 U.S.C. 702.   
§ 1.693 How do I request a regulatory hearing on a revocation of recognition or withdrawal of 
accreditation?  353 
(a) Request for hearing on revocation .  No later than 10 business days after the date of 
issuance of a revocation of re cognition of an accreditation body under §1.634, an individual 
authorized to act on the accreditation body’s behalf may submit a request for a regulatory 
hearing on the revocation under part 16 of this chapter.  The issuance of revocation issued under 
§ 1.634 will contain all of the elements required by §  16.22 of this chapter and will thereby 
constitute the notice of an opportunity for hearing under part 16 of this chapter.  
(b) Request for hearing on withdrawal .  No later than 10 business days after the d ate of 
issuance of a withdrawal of accreditation of a third -party certification body under §1.664, an 
individual authorized to act on the third -party certification body’s behalf may submit a request 
for a regulatory hearing on the withdrawal under part 16 of this chapter.  The issuance of 
withdrawal under §  1.664 will contain all of the elements required by §  16.22 of this chapter and 
will thereby constitute the notice of opportunity of hearing under part 16 of this chapter.  
(c) Submission of request for re gulatory hearing .  The request for a regulatory hearing 
under paragraph (a) or (b) of this section must be submitted with a written appeal that responds 
to the basis for the FDA decision, as described in the issuance of revocation or withdrawal, as 
appropriate, and includ es any supporting information upon which the requestor is relying.  The 
request, appeal, and supporting information must be submitted in English to the address specified 
in the notice and must comply with the procedures it describes.   
(d) Effect of submis sion of request on FDA decision .  The submission of a request for a 
regulatory hearing under paragraph (a) or (b) of this section will not operate to delay or stay the 
effect of a decision by FDA to revoke recognition of an accreditation body or to withdra w 
accreditation of a third -party certification body unless FDA determines that a delay or a stay is in 
the public interest.  354 
(e) Presiding officer .  The presiding officer for a regulatory hearing for a revocation or 
withdrawal under this subpart will be des ignated after a request for a regulatory hearing is 
submitted to FDA.   
(f) Denial of a request for regulatory hearing .  The presiding officer may deny a request 
for regulatory hearing for a revocation or withdrawal under §  16.26(a) of this chapter when no  
genuine or substantial issue of fact has been raised.  
(g) Conduct of regulatory hearing .  (1) If the presiding officer grants a request for a 
regulatory hearing for a revocation or withdrawal, the hearing will be held within 10 business 
days after the dat e the request was filed or, if applicable, within a timeframe agreed upon in 
writing by requestor, the presiding officer, and FDA.  
(2) The presiding officer must conduct the regulatory hearing for revocation or 
withdrawal under part 16 of this chapter, ex cept that, under §  16.5(b) of this chapter, such 
procedures apply only to the extent that the procedures are supplementary and do not conflict 
with the procedures specified for regulatory hearings under this subpart.  Accordingly, the 
following requirement s of part 16 are inapplicable to regulatory hearings under this subpart:  
§ 16.22 ( Initiation of a regulatory hearing ); § 16.24(e) (timing) and (f) (contents of notice); 
§ 16.40 ( Commissioner ); § 16.60(a) (public process); § 16.95(b) (administrative decisi on and 
record for decision) ; and §  16.119 ( Reconsideration and stay of action ). 
(3) A decision by the presiding officer to affirm the revocation of recognition or the 
withdrawal of accreditation is considered a final agency action under 5 U.S.C. 702.  
§ 1.694 Are electronic records created under this subpart subject to the electronic records 
requirements of part 11  of this chapter ?  355 
Records that are established or maintained to satisfy the requirements of this subpart and 
that meet the definition of electron ic records in §  11.3(b)(6) of this chapter are exempt from the 
requirements of part 11 of this chapter.  Records that satisfy the requirements of this subpart, but 
that also are required under other applicable statutory provisions or regulations, remain su bject to 
part 11 of this chapter.  
§ 1.695 Are the records obtained by FDA under this subpart subject to public disclosure?  
Records obtained by FDA under this subpart are subject to the disclosure requirements 
under part 20 of this chapter.  
PART 11--ELECTRONIC RECORDS; ELECTRONIC SIGNATURES  
3. The authority citation for 21 CFR part 11 continues to read as follows:  
Authority :  21 U.S.C. 321 -393; 42 U.S.C. 262.  
4.  In § 11.1, add paragraph (m) to read as follows:  
§ 11.1 Scope.  
* * * * *  
(m) This pa rt does not apply to records required to be established or maintained by 
subpart M of part 1 of this chapter. Records that satisfy the requirements of subpart M of part 1 
of this chapter, but that also are required under other applicable statutory provisio ns or 
regulations, remain subject to this part.  
PART 16 --REGULATORY HEARING BEFORE THE FOOD AND DRUG 
ADMINISTRATION  
5. The authority citation for 21 CFR part 16 continues to read as follows:  
Authority : 15 U.S.C. 1451 -1461; 21 U.S.C. 141 -149, 321 -394, 467f , 679, 821, 1034; 28 
U.S.C. 2112; 42 U.S.C. 201 -262, 263b, 364.  356 
6. In §  16.1(b)(2), add the following entry in numerical order  to read as follows:  
§ 16.1 Scope.  
* * * * *  
(b) * * *  
(2) * * *  
§§ 1.634 and 1.664, relating to revocation of recognition of an a ccreditation body and 
withdrawal of accreditation of third -party certification bodies that conduct food safety audits of 
eligible entities in the food import supply chain and issue food and facility certifications.  
* * * * *  
 
Dated:  October 30, 2015.  
 
Leslie Kux,  
Associate Commissioner for Policy.
[FR Doc. 2015 -28160 Filed: 11/13/2015 8:45 am; Publication Date:  11/27/2015]