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S. 4974IntroducedSenateHouse · nowPresidentLawIn the House
Sec. 2 · S. 4974

Expansion of the accredited third-party certification program

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The wording changed from Committee version to Passed the Senate. Removed words are struck through; added words are underlined.

How the text changed

Committee version → Passed the Senate · Sec. 2

(a) Revised definitions Section 808(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384d(a)) is amended— (1) by striking paragraph (6) and inserting the following: (6) Eligible entity The term eligible entity means a foreign or domestic entity, including a foreign or domestic facility subject to registration under section 415, in the food supply chain that chooses to be audited by an accredited third-party auditor or the audit agent of such accredited third-party auditor.; and (2) in paragraph (7)(B)— (A) in clause (i), by striking; or and inserting a semicolon; (B) in clause (ii), by striking the period and inserting; or; and (C) by adding at the end the following: (iii) whether a facility is eligible to receive a food or facility certification for other purposes described in subsection (c)(2)(B)(ii).. (b) Removing limitations on the use of certifications Section 808(c)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384d(c)(2)) is amended— (1) in subparagraph (A), by striking food certification, described in section 801(q), or facility certification under section 806(a), as appropriate, to accompany each food shipment for import into the United States from an eligible entity and inserting food certification or facility certification for purposes described in subparagraph (B), as appropriate,; and (2) by striking subparagraph (B) and inserting the following: (B) Purpose of certification (i) In general The Secretary shall use certification provided by accredited third-party auditors to— (I) determine, in conjunction with any other assurances the Secretary may require under section 801(q), whether a food satisfies the requirements of such section; and (II) determine whether a facility is eligible to be a facility from which food may be offered for import under the voluntary qualified importer program under section 806. (ii) Other considerations The Secretary may consider the results of regulatory audits and food or facility certifications provided by accredited third-party auditors under this section in analyzing risks and prioritizing inspections and other regulatory activities, as appropriate for the protection of public health.. (c) Technical and conforming amendments Section 808 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384d) is amended— (1) in subsection (b)(1), (b)(1)(A)— (A) by amending subparagraph (A) to read as follows: (A) Recognition of striking accreditation bodies in the subparagraph heading and all that follows through Not later than 2 years after in clause (i) and inserting the date of enactment of the Making America's Food Safer Act, the Secretary shall establish a system for the recognition of following: accreditation bodies that accredit third-party auditors to certify that eligible entities meet the applicable requirements of this section.; bodies— Not later than; and (B) by striking clause (ii); (2) in subsection (c)— (A) in paragraphs (1) and (2), by striking (or, in the case of direct accreditation under subsection (b)(1)(A)(ii), the Secretary) each place it appears; (B) in paragraph (2)(C)(i), by striking food certification under section 801(q) or a facility certification described under this subparagraph (B) and inserting food certification or a facility certification described in this section; (C) in paragraph (6)(A)(i), by striking food certified under section 801(q) or from a facility certified under paragraph (2)(B) and inserting food or a facility certified under this section; (D) in paragraph (6)(C), by striking requirements under section 801(q), of certifying the food, or the requirements under paragraph (2)(B) of certifying the entity and inserting requirements for certifying the food or facility under this section; and (E) in paragraph (7)(B)(i), by striking, through direct accreditation under subsection (b)(1)(A)(ii) or; and (3) in subsection (d)— (A) in paragraph (1), by striking or; and (B) at the end of paragraph (2), by striking the period and inserting; or; and (C) by adding at the end the following new paragraph: (3) otherwise seeks certification for purposes of subsection (c)(2)(B)(ii)..

•S 4974 ESSEC. 2

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