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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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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).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2017]
[CITE: 21CFR1.624]



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 Accreditation Bodies That Have Been Recognized Under This Subpart

Sec. 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 officers, 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 course of an assessment and on the premises where the assessment is conducted, if necessary to facilitate the efficient conduct of the assessment.

(b) A recognized accreditation body may accept the payment of fees for accreditation services and the reimbursement 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 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 a recognized accreditation body's officers, employees, and other agents involved in accreditation activities 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 bodies 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, the certification body is reaccredited, or the scope of accreditation is reinstated, whichever comes first.

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