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Federal Register / Vol. 86, No. 180 / Tuesday, September 21, 2021 / Rules and Regulations determine if this category of actions would individually or cumulatively result in significant effects on the environment and will proceed as appropriate.
Comment 20 One comment notes that establishment of an import tolerance should also have no appreciable environmental effect outside the United States. If the new animal drug is not expected to have significant environmental impacts in the country where it is registered for use, it is hard to imagine a situation where movement of residues to another country or into the global commons, such as the open ocean, would present a significant environmental risk.
Response 20 We agree with the comments assessment of the low risk of significant environmental effects abroad of residues of new animal drugs appropriately registered in the country they are used based on our experience to date. An analysis of effects abroad is not currently required in the EA for establishment of an import tolerance;
however, when necessary, such an analysis will be completed by the Agency.
VI. Effective Date The rule is effective January 19, 2022.

VII. Economic Analysis of Impacts We have examined the impacts of the final rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act 5 U.S.C. 601612, and the Unfunded Mandates Reform Act of 1995 Pub. L. 1044. Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity. We believe that this final rule is not a significant regulatory action as defined by Executive Order 12866.
The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities.
Because the final rule will simply codify the procedures that are currently used for the import tolerance program, we certify that the final rule will not have a significant economic impact on a substantial number of small entities.
The Unfunded Mandates Reform Act of 1995 section 202a requires us to prepare a written statement, which
includes an assessment of anticipated costs and benefits, before issuing any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more adjusted annually for inflation in any one year.
The current threshold after adjustment for inflation is $158 million, using the most current 2020 Implicit Price Deflator for the Gross Domestic Product.
This final rule would not result in an expenditure in any year that meets or exceeds this amount.
Summary of Cost and Benefits Firms are currently able to request that we establish or amend an import tolerance. The final rule will not change the current procedures for these requests. Thus, we include only the incremental costs of reading and understanding the final rule on import tolerance procedures.
In table 2, FDA provides the Regulatory Information Service Center and Office of Information and Regulatory Affairs Consolidated Information Center accounting information.

TABLE 2ECONOMIC DATA: COSTS AND BENEFITS STATEMENT
Units Primary estimate
Low estimate
High estimate

Category
Benefits:
Annualized, Monetized $millions/year
Annualized Quantified

Qualitative

Costs:
Annualized, Monetized $millions/year
Annualized
Quantified
Qualitative

lotter on DSK11XQN23PROD with RULES1

Transfers:
Federal Annualized Monetized $millions/year

Year dollars
Discount rate %

Period covered years

7
3 7
3

Notes
Codifying current practices of the import tolerance program could improve the efficiency of the program.

<$0.0001 <$0.0001

<$0.0001 <$0.0001

<$0.0001 <$0.0001

2020
2020

7
3 7
3

10
10

7
3

7
3

From/To

From:

Other
Annualized, Monetized $millions/year

From/To

From:

To:

To:

Effects:
State, Local or Tribal Government: No Effect.
Small Business: The final rule will not have a significant impact on a substantial number of small entities that manufacture unapproved drugs that are the subject of an import tolerance request.
Wages: No effect.
Growth: No effect.

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