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Federal Register / Vol. 86, No. 180 / Tuesday, September 21, 2021 / Rules and Regulations B. General Overview of the Final Rule In issuing this rule, the Agency finalizes the provisions in the January 2012 proposed rule 77 FR 3653, January 25, 2012. This final rule reflects revisions the Agency made after considering all comments received.
This final rule amends part 510 by adding sections to establish the scope of new subpart C 510.201 21 CFR
510.201; to define certain relevant terms 510.202 21 CFR 510.202; to establish who may initiate proceedings to establish or amend an import tolerance 510.203 21 CFR 510.203;
to describe the content, options for submission, and administration of a request to establish or amend an import tolerance 510.205 21 CFR 510.205;
and to describe the review of information to establish or amend an import tolerance 510.206 21 CFR
510.206. Provisions describing when and how information relating to import tolerances will be publicly disclosed, previously in proposed 510.205, are now described and organized in redesignated 510.207 21 CFR
510.207. Procedures that FDA follows in establishment, denial of a request for establishment, and amendment of an import tolerance are described in redesignated 510.209 21 CFR
510.209. Procedures for revocation of an import tolerance are described in redesignated 510.210 21 CFR
510.210. Procedures for requesting reconsideration or administrative stay of a decision to establish, amend, or revoke an import tolerance are specified in redesignated 510.212 and 510.213 21
CFR 510.212 and 510.213, respectively.
IV. Legal Authority We are issuing these regulations under the legal authority provided by section 512a6 of the FD&C Act 21
U.S.C. 360ba6 relating to the establishment of import tolerances for unapproved new animal drugs and under section 701a of the FD&C Act 21 U.S.C. 371a, which gives FDA
general rulemaking authority to issue regulations for the efficient enforcement of the FD&C Act.

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V. Comments on the Proposed Rule and FDA Response We received 17 comments on the proposed import tolerance rule by the close of the comment period, each commenting on one or more aspects of the proposed rule. We received comments from a wide array of members of the public, including trade organizations, academia, public advocacy groups, consumers, and government agencies. The comments
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addressed numerous provisions of the proposed rule, including our specific requests for comments set forth in the proposed rule. Some comments addressed issues that are outside of the scope of this rule. Because such comments were beyond the scope of this rule, we do not include a discussion of them here.
A. General Comments on the Proposed Rule and FDA Response Comment 1 Several comments expressed concern that establishment of import tolerances for unapproved new animal drugs is unfair to domestic producers who cannot legally use these drugs, thereby putting them at a competitive disadvantage.
Response 1 The ADAA amended the FD&C Act to permit FDA to establish a tolerance for residues of a new animal drug in any edible portion of any animal imported into the United States when the intended use of the new animal drug is not approved for use in the United States. The legislative history notes there may be appropriate instances e.g., the disease treated does not exist in the United States in which food-producing animals in other countries are treated with animal drugs that are not approved in the United States. Thus, Congress enacted this provision to provide a legal means by which food that may contain residues of these drugs may be imported into the United States. Under the FD&C
Act, lawful use of the same animal drug in the United States requires that the new animal drug be approved or conditionally approved by FDA. This requires additional information and data from the sponsor to establish, among other things, that the drug is effective for its intended use and safe for the animals receiving the drug.
Comment 2 One comment states that establishing import tolerances would result in an increase in the volume of contaminated seafood into the United States.
Response 2 FDA notes that one consequence of establishing an import tolerance may be an increase in imported edible tissues from foodproducing animals treated with the drug that is the subject of an import tolerance. However, these imported tissues will not be permitted entry if they contain residues above the import tolerance, the maximum concentration of residues of the new animal drug in the edible tissues that is determined to be safe for human consumers.
Comment 3 A few comments express concern that import tolerances risk exposing U.S. consumers to unsafe tissue residues.

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Response 3 Section 512a6 of the FD&C Act requires that the Agency rely on human food safety criteria similar to those used to establish tolerances for approved new animal drugs when establishing import tolerances. The human food safety criteria and review processes resulting in establishment of tolerances for domestically approved new animal drugs and for import tolerances for unapproved new animal drugs are fundamentally the same.
Whether the Agency is establishing an import tolerance or a tolerance in the course of approving or conditionally approving a new animal drug, we require data and information to demonstrate that the residues of the new animal drug in the edible products of treated animals are safe for human consumers. Imported tissues will not be allowed entry into the United States if they contain residues above the import tolerance.
Comment 4 One comment states that the rule should include a requirement that the country in which the unapproved new animal drug is legally used have an equivalent animal drug regulatory program. In addition, a few comments recommend requiring that the requester submit: A record of the foreign countrys approval actions and the approved uses of the new animal drug in other countries; information on alternative treatments or competing new animal drugs and an explanation of why the use of an unapproved new animal drug is necessary in light of alternatives;
and an affidavit that there are no FDAapproved new animal drugs to treat the disease or condition for which the unapproved new animal drug is indicated. The comments also recommend that the requester be required to comply with the requirement to report adverse drug events and that food containing such new animal drug residues originate from a country that has approved the drug and is actively monitoring its use.
Response 4 We disagree. Under the FD&C Act, to establish an import tolerance, FDA only must consider information related to the human food safety of the unapproved new animal drug that is the subject of the import tolerance. The data sufficient to demonstrate that residues of the unapproved new animal drug that is the subject of a proposed import tolerance are safe is based on similar food safety criteria used to establish tolerances for new animal drugs approved in the United States. That is, the human food safety standard for domestically approved new animal drugs and new animal drugs for which an import tolerance is established is the same:

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