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Federal Register / Vol. 86, No. 180 / Tuesday, September 21, 2021 / Rules and Regulations
D. Costs and Benefits 1. Costs of the Final Rule All entities affected by this final rule will incur the one-time cost for reading
and understanding this rule. Based on the small number of firms that we estimate could request an import tolerance per year, only about five firms would need to read and understand this
rule over the next 10 years. The total costs for reading and understanding the rule range from around $530 to around $660. Table 1 includes a summary of these costs.

TABLE 1ONE-TIME COSTS FOR READING AND UNDERSTANDING THE RULE
2020 Dollars Low
High
Reading time hours
Wage $ per hour
Affected entities
Number of people reading per entity

0.75
$140.30
5 1

0.85
$140.30
5 1

1
$140.30
5 1

Total cost

$530

$585

$660

2. Benefits of the Final Rule The procedures codified herein clarify the import tolerance submission process for the establishment, amendment, and
revocation of these tolerances. This should result in improving the efficiency of the program for both industry and government. However, we
lack data to quantify these efficiency gains.
II. Table of Abbreviations/Commonly Used Acronyms in This Document
Abbreviation
What it means
ADAA
ADI
CFR
CNADA
Codex MRL
CVM
FAO
FDA
FD&C Act
GMP
GFI
JECFA
JMPR
MRL
NADA
US
VICH

Animal Drug Availability Act of 1996.
Acceptable Daily Intake.
Code of Federal Regulations.
Application for Conditional Approval of a New Animal Drug.
MRL established by the Codex Alimentarius Committee.
Center for Veterinary Medicine.
Food and Agriculture Organization of the United Nations.
U.S. Food and Drug Administration.
Federal Food, Drug, and Cosmetic Act.
Good Manufacturing Process.
Guidance for Industry.
Joint FAO/WHO Expert Committee on Food Additives.
Joint FAO/WHO Meeting on Pesticide Residues.
Maximum Residue Limit.
New Animal Drug Application.
United States.
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products.
World Health Organization of the United Nations.

WHO

III. Background A. History and Scope of This Rulemaking
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In 1996, the President signed into law the Animal Drug Availability Act of 1996 ADAA Pub. L. 104250, which amended the FD&C Act 21 U.S.C.
360ba to authorize the establishment of import tolerances that would provide a basis for the legal marketing of imported animal-derived food containing residues of new animal drugs neither approved nor conditionally approved in the United States unapproved new animal drugs.
Without an import tolerance, any amount of residue of an unapproved new animal drug in imported, animalderived food would cause that food to be adulterated under section 402a2Cii of the FD&C Act 21
U.S.C. 342a2Cii because the drug
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would be deemed unsafe under section 512 of the FD&C Act 21 U.S.C. 360b.
Such food could be denied entry into the United States under section 801a3 of the FD&C Act 21 U.S.C.
381a3. It remains unlawful to import animal-derived food containing a residue of an unapproved new animal drug, unless an import tolerance has been established for such drug and any residue of the new animal drug in the imported animal-derived food does not exceed that import tolerance. These regulations establish procedures under which the Agency will establish, amend, or revoke import tolerances for residues of unapproved new animal drugs.
The ADAA also specified that in establishing import tolerances, FDA
must rely on data sufficient to demonstrate that a proposed tolerance is safe based on similar food safety criteria
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used to establish a tolerance under a new animal drug application NADA.
For establishment of import tolerances, food safety data can be submitted by the drug manufacturer or be available from a relevant international organization such as the Codex Alimentarius Commission, provided such data are not inconsistent with criteria used to establish a tolerance for new animal drugs in NADAs.
The regulations make it clear that the Commissioner may start a review process to establish, amend, or revoke an import tolerance on his or her own initiative under 10.25b. These regulations also establish when import tolerance-related actions actions resulting in establishment, amendment, or revocation and their basis will be publicly disclosed.

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