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Federal Register / Vol. 86, No. 180 / Tuesday, September 21, 2021 / Rules and Regulations
Reasonable certainty of no harm. The data that may be considered include data submitted to appropriate regulatory authorities in any country where the new animal drug is lawfully used and data available from an appropriate international organization, to the extent such data are not inconsistent with the criteria used to establish a tolerance for applications for new animal drugs in the United States.
The FD&C Act does not require the Agency to consider the use of the drug in other countries including the diseases for which the unapproved new animal drug is indicated and whether there are approved drugs or alternative treatments available, or that the countryies where the drug is approved have an equivalent regulatory program e.g., any post-approval monitoring. In addition, the FD&C Act does not impose adverse drug event reporting requirements for the establishment of import tolerances.
Once an import tolerance is established, imported animal-derived food that contains residues of the unapproved new animal drug may enter the United States if those residues are below the import tolerance. There is no requirement that the imported food originate from a country that has approved the drug.
Comment 5 Two comments state that U.S. consumers should be informed at the point of sale or through product labeling that imported edible tissues from food-producing animals may contain residues of new animal drugs that are not approved for use in the United States.
Response 5 FDA does not agree that such public disclosure is needed to address the safety of residues from drugs for which import tolerances are established. The purpose of the legislation was to ensure that any edible portion of any animal imported into the United States is safe so long as such residues are below the established import tolerance.
Comment 6 One comment states that establishing import tolerances undermines the new animal drug approval process. The commenter further states that FDAs estimate that an import tolerance review will require 100 hours of a mid-level FDA
employees time is evidence that the import tolerance review will be less stringent.
Response 6 We disagree that establishment of import tolerances undermines the new animal drug approval process. Congress recognized that there may be appropriate instances in which food-producing animals in other countries are treated with animal
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drugs that are not approved in the United States. For example, the disease being treated does not exist in the United States, or the particular animal industry either may not exist in the United States or is very small, resulting in a limited or nonexistent market for the drug in the United States. Nor do we agree that our estimate that an import tolerance review will generally require 100 hours of a mid-level FDA
employees time is evidence that import tolerance review is less stringent than review of proposed tolerances as part of a new animal drug application. The human food safety standard for domestically approved drugs and drugs for which an import tolerance is established is the same: Reasonable certainty of no harm. Whether a person is requesting that the Agency establish an import tolerance or approve an NADA, the requester or sponsor, respectively, is required to furnish FDA
with evidence demonstrating that the residues of the new animal drug in the edible products of treated animals are safe for human consumption. In our experience, it requires about 100 hours of a mid-level FDA employees time to review this evidence, whether submitted under a new animal drug application or a request to establish an import tolerance.
Comment 7 One comment states that tolerances should only be considered for an unapproved animal drug that is used solely for therapeutic purposes, asserting that the ADAA was intended to establish import tolerances for situations where a drug is used for treating diseases and conditions that do not occur in the United States.
Response 7 We disagree. The plain language of the statute does not limit the establishment of import tolerances to new animal drugs intended to be used solely for therapeutic purposes.
Generally, the reason an animal drug developer does not seek approval of the new animal drug in the United States with attendant tolerances is because the particular animal-rearing industry may not exist in the United States at a scale to justify the expense of seeking FDA approval. In some cases, the new animal drug may be used for nontherapeutic purposes.
B. Comments on Information To Support Establishment of an Import Tolerance and FDA Response Comment 8 One comment notes that the phrase some assurance that the drugs are manufactured under GMP
conditions, a comment provided by a Veterinary Medicine Advisory Committee during a public meeting held on this topic in January 2002, and
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discussed in the preamble to the proposed rule, seems to go beyond the scope of what is necessary to ensure public safety and should be interpreted with broad flexibility.
Response 8 We agree. As noted previously, section 512a6 of the FD&C Act provides that FDA shall rely on data sufficient to demonstrate that a proposed tolerance is safe based on similar food safety criteria used to establish tolerances for NADAs filed under section 512b1 of the FD&C Act.
Section 512a6 of the FD&C Act does not require the Agency to consider other requirements, such as an assurance of good manufacturing processes GMPs, applicable to the new animal drug approval process in determining whether the Agency should grant a request to establish an import tolerance.
Comment 9 Two comments assert that conditions of use of unapproved animal drugs do not need to be considered in establishing import tolerances so long as residues in imported tissues are below the import tolerance.
Response 9 We disagree. Information about the conditions of use of the new animal drug must be considered when deciding to establish or amend an import tolerance so that the relevance of the submitted human food safety data, particularly tissue residues that may result from the lawful dosing regimen, can be determined. The tissue residue concentration is affected by the dosing regimen, i.e., the dose level and duration for which the animal is treated.
Knowing that the new animal drug tissue concentrations reported in the human food safety studies are the result of animals dosed under the same conditions of use as described in the request provides FDA with assurance that the residue data are an appropriate basis to make decisions regarding whether to establish or amend an import tolerance.
Comment 10 One comment expressed concern that proposed 510.205, now 510.205e5, which provides that a request for an import tolerance may include other human food safety information as deemed necessary by the Commissioner, is too broad, and that the possibility of ad hoc requirements may serve to curtail the initiation of requests or frustrate the efforts of those who do submit import tolerance requests.
Response 10 The Agency does not intend to use this provision to require more human food safety information than is necessary to assess whether residues of unapproved new animal drugs in edible tissues of treated animals are safe for human
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