Title 21

PART 1 SUBPART M

Subpart M - Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications Source:80 FR 74650, Nov. 27, 2015, unless otherwise noted.

• 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, 342, 343, 350c, 350d, 350e, 350j, 350k, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371, 373, 374, 379j-31, 381, 382, 384, 384a, 384b, 384d, 387, 387a, 387c, 393; 42 U.S.C. 216, 241, 243, 262, 264, 271; Pub. L. 107-188, 116 Stat. 594, 668-69; Pub. L. 111-353, 124 Stat. 3885, 3889.
• Source: 42 FR 15553, Mar. 22, 1977, unless otherwise noted.

21:1.0.1.1.1.12.47	SUBJGRP 47	Recognition of Accreditation Bodies Under This Subpart
21:1.0.1.1.1.12.47.1	SECTION 1.600	1.600 What definitions apply to this subpart
21:1.0.1.1.1.12.47.2	SECTION 1.601	1.601 Who is subject to this subpart
21:1.0.1.1.1.12.47.3	SECTION 1.610	1.610 Who is eligible to seek recognition
21:1.0.1.1.1.12.47.4	SECTION 1.611	1.611 What legal authority must an accreditation body have to qualify for recognition
21:1.0.1.1.1.12.47.5	SECTION 1.612	1.612 What competency and capacity must an accreditation body have to qualify for recognition
21:1.0.1.1.1.12.47.6	SECTION 1.613	1.613 What protections against conflicts of interest must an accreditation body have to qualify for recognition
21:1.0.1.1.1.12.47.7	SECTION 1.614	1.614 What quality assurance procedures must an accreditation body have to qualify for recognition
21:1.0.1.1.1.12.47.8	SECTION 1.615	1.615 What records procedures must an accreditation body have to qualify for recognition
21:1.0.1.1.1.12.48	SUBJGRP 48	Requirements for Accreditation Bodies That Have Been Recognized Under This Subpart
21:1.0.1.1.1.12.48.9	SECTION 1.620	1.620 How must a recognized accreditation body evaluate third-party certification bodies seeking accreditation
21:1.0.1.1.1.12.48.10	SECTION 1.621	1.621 How must a recognized accreditation body monitor the performance of third-party certification bodies it accredited
21:1.0.1.1.1.12.48.11	SECTION 1.622	1.622 How must a recognized accreditation body monitor its own performance
21:1.0.1.1.1.12.48.12	SECTION 1.623	1.623 What reports and notifications must a recognized accreditation body submit to FDA
21:1.0.1.1.1.12.48.13	SECTION 1.624	1.624 How must a recognized accreditation body protect against conflicts of interest
21:1.0.1.1.1.12.48.14	SECTION 1.625	1.625 What records requirements must an accreditation body that has been recognized meet
21:1.0.1.1.1.12.49	SUBJGRP 49	Procedures for Recognition of Accreditation Bodies Under This Subpart
21:1.0.1.1.1.12.49.15	SECTION 1.630	1.630 How do I apply to FDA for recognition or renewal of recognition
21:1.0.1.1.1.12.49.16	SECTION 1.631	1.631 How will FDA review my application for recognition or renewal of recognition and what happens once FDA decides on my application
21:1.0.1.1.1.12.49.17	SECTION 1.632	1.632 What is the duration of recognition
21:1.0.1.1.1.12.49.18	SECTION 1.633	1.633 How will FDA monitor recognized accreditation bodies
21:1.0.1.1.1.12.49.19	SECTION 1.634	1.634 When will FDA revoke recognition
21:1.0.1.1.1.12.49.20	SECTION 1.635	1.635 What if I want to voluntarily relinquish recognition or do not want to renew recognition
21:1.0.1.1.1.12.49.21	SECTION 1.636	1.636 How do I request reinstatement of recognition
21:1.0.1.1.1.12.50	SUBJGRP 50	Accreditation of Third-Party Certification Bodies Under This Subpart
21:1.0.1.1.1.12.50.22	SECTION 1.640	1.640 Who is eligible to seek accreditation
21:1.0.1.1.1.12.50.23	SECTION 1.641	1.641 What legal authority must a third-party certification body have to qualify for accreditation
21:1.0.1.1.1.12.50.24	SECTION 1.642	1.642 What competency and capacity must a third-party certification body have to qualify for accreditation
21:1.0.1.1.1.12.50.25	SECTION 1.643	1.643 What protections against conflicts of interest must a third-party certification body have to qualify for accreditation
21:1.0.1.1.1.12.50.26	SECTION 1.644	1.644 What quality assurance procedures must a third-party certification body have to qualify for accreditation
21:1.0.1.1.1.12.50.27	SECTION 1.645	1.645 What records procedures must a third-party certification body have to qualify for accreditation
21:1.0.1.1.1.12.51	SUBJGRP 51	Requirements for Third-Party Certification Bodies That Have Been Accredited Under This Subpart
21:1.0.1.1.1.12.51.28	SECTION 1.650	1.650 How must an accredited third-party certification body ensure its audit agents are competent and objective
21:1.0.1.1.1.12.51.29	SECTION 1.651	1.651 How must an accredited third-party certification body conduct a food safety audit of an eligible entity
21:1.0.1.1.1.12.51.30	SECTION 1.652	1.652 What must an accredited third-party certification body include in food safety audit reports
21:1.0.1.1.1.12.51.31	SECTION 1.653	1.653 What must an accredited third-party certification body do when issuing food or facility certifications
21:1.0.1.1.1.12.51.32	SECTION 1.654	1.654 When must an accredited third-party certification body monitor an eligible entity that it has issued a food or facility certification
21:1.0.1.1.1.12.51.33	SECTION 1.655	1.655 How must an accredited third-party certification body monitor its own performance
21:1.0.1.1.1.12.51.34	SECTION 1.656	1.656 What reports and notifications must an accredited third-party certification body submit
21:1.0.1.1.1.12.51.35	SECTION 1.657	1.657 How must an accredited third-party certification body protect against conflicts of interest
21:1.0.1.1.1.12.51.36	SECTION 1.658	1.658 What records requirements must a third-party certification body that has been accredited meet
21:1.0.1.1.1.12.52	SUBJGRP 52	Procedures for Accreditation of Third-Party Certification Bodies Under This Subpart
21:1.0.1.1.1.12.52.37	SECTION 1.660	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
21:1.0.1.1.1.12.52.38	SECTION 1.661	1.661 What is the duration of accreditation by a recognized accreditation body
21:1.0.1.1.1.12.52.39	SECTION 1.662	1.662 How will FDA monitor accredited third-party certification bodies
21:1.0.1.1.1.12.52.40	SECTION 1.663	1.663 How do I request an FDA waiver or waiver extension for the 13-month limit for audit agents conducting regulatory audits
21:1.0.1.1.1.12.52.41	SECTION 1.664	1.664 When would FDA withdraw accreditation
21:1.0.1.1.1.12.52.42	SECTION 1.665	1.665 What if I want to voluntarily relinquish accreditation or do not want to renew accreditation
21:1.0.1.1.1.12.52.43	SECTION 1.666	1.666 How do I request reaccreditation
21:1.0.1.1.1.12.53	SUBJGRP 53	Additional Procedures for Direct Accreditation of Third-Party Certification Bodies Under This Subpart
21:1.0.1.1.1.12.53.44	SECTION 1.670	1.670 How do I apply to FDA for direct accreditation or renewal of direct accreditation
21:1.0.1.1.1.12.53.45	SECTION 1.671	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
21:1.0.1.1.1.12.53.46	SECTION 1.672	1.672 What is the duration of direct accreditation
21:1.0.1.1.1.12.54	SUBJGRP 54	Requirements for Eligible Entities Under This Subpart
21:1.0.1.1.1.12.54.47	SECTION 1.680	1.680 How and when will FDA monitor eligible entities
21:1.0.1.1.1.12.54.48	SECTION 1.681	1.681 How frequently must eligible entities be recertified
21:1.0.1.1.1.12.55	SUBJGRP 55	General Requirements of This Subpart
21:1.0.1.1.1.12.55.49	SECTION 1.690	1.690 How will FDA make information about recognized accreditation bodies and accredited third-party certification bodies available to the public
21:1.0.1.1.1.12.55.50	SECTION 1.691	1.691 How do I request reconsideration of a denial by FDA of an application or a waiver request
21:1.0.1.1.1.12.55.51	SECTION 1.692	1.692 How do I request internal agency review of a denial of an application or waiver request upon reconsideration
21:1.0.1.1.1.12.55.52	SECTION 1.693	1.693 How do I request a regulatory hearing on a revocation of recognition or withdrawal of accreditation
21:1.0.1.1.1.12.55.53	SECTION 1.694	1.694 Are electronic records created under this subpart subject to the electronic records requirements of part 11 of this chapter
21:1.0.1.1.1.12.55.54	SECTION 1.695	1.695 Are the records obtained by FDA under this subpart subject to public disclosure
21:1.0.1.1.1.12.56	SUBJGRP 56	Requirements for User Fees Under This Subpart
21:1.0.1.1.1.12.56.55	SECTION 1.700	1.700 Who is subject to a user fee under this subpart
21:1.0.1.1.1.12.56.56	SECTION 1.705	1.705 What user fees are established under this subpart
21:1.0.1.1.1.12.56.57	SECTION 1.710	1.710 How will FDA notify the public about the fee schedule
21:1.0.1.1.1.12.56.58	SECTION 1.715	1.715 When must a user fee required by this subpart be submitted
21:1.0.1.1.1.12.56.59	SECTION 1.720	1.720 Are user fees under this subpart refundable
21:1.0.1.1.1.12.56.60	SECTION 1.725	1.725 What are the consequences of not paying a user fee under this subpart on time

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