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Federal Register / Vol. 86, No. 180 / Tuesday, September 21, 2021 / Rules and Regulations
human food safety standard reasonable certainty of no harm as we apply to all new animal drugs, including antimicrobial new animal drugs, seeking approval under an NADA or application for conditional approval of a new animal drug CNADA. For requests for import tolerances for antimicrobials, FDA evaluates the impacts on human health, including the potential transmission of antimicrobial resistant bacteria of human health concern through the consumption of animalderived food products. To assess these impacts, FDA recommends conducting the qualitative risk assessment described in Guidance for Industry GFI
152 entitled Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern, October 23, 2003.1 In addition, we recommend that requesters address the step-wise approach outlined in GFI
159 VICH GL36, Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish a Microbiological ADI, March 5, 2013,2 to assure the Agency that any impacts of antimicrobial new animal drug residues on the intestinal flora of human consumers are minimal. By addressing these important human food safety endpoints for antimicrobial new animal drugs, requesters will be able to assure the Agency that the imported animalderived food products are safe for human consumption.
Comment 16 A comment stated that the rule should specifically prohibit the setting of import tolerances for veterinary drugs that have extralabel use restrictions in the United States or that are banned from use in domestic livestock enterprises including aquaculture.
Response 16 As noted previously, whether a person is requesting 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. If the requester can satisfy the human food safety requirements, the Agency may establish an import tolerance for a food-producing species for which there is no extralabel use restriction, even if an extralabel use 1 Available at: https www.fda.gov/media/69949/
download.
2 Available at: https www.fda.gov/regulatoryinformation/search-fda-guidance-documents/cvmgfi-159-vich-gl36-studies-evaluate-safety-residuesveterinary-drugs-human-food-general-approach.

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prohibition exists for other foodproducing species.
Comment 17 One comment requests that the requirement that the unapproved animal drug be registered lawfully used in another country should be revised to allow a request for an import tolerance to simultaneously progress with registration of the drug in foreign countries.
Response 17 The statute gives us discretion to consider and rely on data submitted by the drug manufacturer, including data submitted to appropriate regulatory authorities in any country where the new animal drug is lawfully used. As we noted in the preamble to the proposed rule, the Agency has interpreted this statutory language to mean that we may establish an import tolerance for a new animal drug that is not approved or conditionally approved in the United States but that is lawfully used in another country. Thus, foreign lawful use in at least one country must occur before a request to establish an import tolerance is submitted to the Agency.
Comment 18 One comment requests that FDA revise the evidentiary standard for revocation of an import tolerance to be evidence to show a reasonable basis from which serious questions may be inferred about the ultimate safety of the unapproved new animal drug residue and any substance that may be formed as a result of the unapproved new animal drugs use. The comment raises the concern that the proposed rule appears to require consumers to bring conclusive evidence to obtain a review of the import tolerance.
Response 18 We disagree. The standard for revoking an import tolerance is provided for in section 512a6 of the FD&C Act, which states that the Agency may revoke an import tolerance if information demonstrates that the use of the new animal drug under actual use conditions results in food being imported into the United States with residues exceeding the tolerance or if scientific evidence shows the tolerance to be unsafe. The final rule reflects this standard in 510.210a. An import tolerance can be revoked upon petition or by the initiative of the Commissioner.
C. Comments on Environmental Review and FDA Response Comment 19 In the preamble to the proposed rule, the Agency requested comments and supporting information relevant to the issue of whether import tolerances will have a significant effect on the environment in the United States or abroad. FDA received two comments indicating that available information
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shows that FDAs establishment of import tolerances should present no appreciable risk to the environment from either the consumption or disposal of edible tissues containing residues of animal drugs. Two comments support creation by FDA of a categorical exclusion from the requirement to prepare an environmental assessment EA for an import tolerance request. For example, one comment presents evidence why risks to the environment should not be significant, showing calculations and summarizing information indicating that residues in certain media e.g., wastewater, soil would be below threshold criteria already established by FDA in guidance documents or in existing categorical exclusions for other actions. Thus, the basis for establishing a new categorical exclusion for import tolerances is already in place.
Response 19 We agree with the comments assessment of the low risk of significant environmental impacts from either the consumption or disposal of edible tissues containing residues of animal drugs. Since the 2012 proposed rule, we have reviewed EAs for several import tolerance requests for new animal drugs used in both aquatic and terrestrial environments aquatic:
Azamethiphos and lufenuron in salmonids, benzocaine in Atlantic salmon and rainbow trout, and emamectin and teflubenzuron in Atlantic salmon; terrestrial: Monensin and monepantel in sheep; see https
www.fda.gov/AnimalVeterinary/
Products/ImportExports/
ucm315830.htm. Regardless of the environment in which the drugs were used, each EA described the introduction of drug residues into the domestic environment as being through the consumption of food resulting in: 1
Excreta entering sewage treatment facilities and 2 waste of edible tissues disposed of in landfills. Each EA
resulted in a finding by the Agency of no significant environmental impact;
thus, for each import tolerance action a finding of no significant impact was prepared.
In response to comments that FDA
create a categorical exclusion from the requirement to prepare an EA for an action on an import tolerance, the Agency is considering proposing a new categorical exclusion specific to establishment, amendment, or revocation of an import tolerance. This would require review by the White House Council on Environmental Quality, as well as additional rulemaking with public notice and comment. The Agency is currently evaluating available information to
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