• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

  • Print
  • Share
  • E-mail
-

The information on this page is current as of April 1 2017.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

New Search
Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2017]
[CITE: 21CFR1.657]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER A--GENERAL

PART 1 -- GENERAL ENFORCEMENT REGULATIONS

Subpart M--Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications

Requirements for Third-Party Certification Bodies That Have Been Accredited Under This Subpart

Sec. 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 certification 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 and 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 financial 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

(4) Prohibiting an accredited third-party certification body'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 paragraph (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 minimis 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 and 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, and 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 must 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 facility 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.

-
-