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Federal Register / Vol. 86, No. 53 / Monday, March 22, 2021 / Proposed Rules Estimated number of respondents:
EPA estimates that registrants submit 60
data packages to the Agency annually for efficacy review. Some registrants may submit multiple data packages per year. Under this rule the number of submissions may declineand therefore the number of respondents may also decrease.
Frequency of response: On occasion.
Total estimated burden: The proposed rule is expected to reduce burden hours by 4,683 annually, including 4,515
hours from reduced paperwork burden associated with data generation and 168
hours from reduced paperwork burden associated with the application process.
Burden is defined at 5 CFR 1320.3b.
EPA already accounts for the activities associated with the proposed rule in the currently approved ICR, which covers most activities associated with new and amended registrations; EPA estimates a total annual respondent burden of 1.5
million hours for all these activities. As discussed in the Proposed Rule-related ICR Amendment Ref. 49, 483,000 of those hours are paperwork burden from data generation for new products, and 102,000 of those hours are paperwork burden from application for new and amended products.
Total estimated cost: The estimated burden reduction is expected to reduce burden cost by $330,000 annually, including $315,000 from reduced paperwork burden associated with data generation and $15,000 from reduced paperwork burden associated with the application process, which includes $0
annualized capital or operation and maintenance costs. EPA already accounts for the activities associated with the proposed rule in the currently approved ICR, which covers most activities associated with new and amended registrations; EPA estimates a total annual respondent burden of $109
million for all these activities. As discussed in the Proposed Rule ICR
Ref. 49, $33.7 million of that cost is paperwork burden from data generation for new products, and $9.3 million of that cost is paperwork burden from application for new and amended products.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB
control number. The OMB control numbers for EPAs regulations in 40
CFR are listed in 40 CFR part 9.
Submit your comments on the Agencys need for this information, the accuracy of the provided burden estimates and any suggested methods for minimizing respondent burden to the EPA using the docket identified at
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the beginning of this rule. You may also send your ICR-related comments to OMBs Office of Information and Regulatory Affairs via email to OIRA_
submission@omb.eop.gov, Attention:
Desk Officer for the EPA.
C. Regulatory Flexibility Act RFA
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA, 5 U.S.C. 601 et seq. In making this determination, the impact of concern is any significant adverse economic impact on small entities. An agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burden, has no net burden, or otherwise has a positive economic effect on the small entities subject to the rule. EPAs small entity analysis suggests that the greatest impact, and the most potential cost savings, would accrue to small entities and new registrants. While large, established registrants have experience with the registration process and are aware of EPAs data requirements or have the means to determine the appropriate studies, new and small registrants without that experience may bear significant costs of acquiring this information. The registrants would have easier access to the data requirements, and the reduction in information acquisition costs would be largest for those registrants with the greatest information acquisition needs. Thus, EPA anticipates that the proposed rule would result in cost savings, particularly for small and first-time registrants. While the affected NAICS
codes contain up to 5,438 small entities, EPA does not expect all entities to experience cost savings in all years as a result of this proposed rule. As the cost analysis Ref. 1 describes, a sample of 30 applications was selected at random.
These applications were submitted by 16 different firms, four of which EPA
was able to identify as small businesses according to the Small Business Administration Employees or Revenue Thresholds. About 60 packages are received annually by EPA for control claims. Therefore, EPA expects that, on average, approximately ten small entities will experience cost savings each year as a result of this proposed rule.
While not every element of the proposed rule would result in savings for registrants, EPA conservatively estimates that the rule would result in $1 million in annual reductions in registrant expenditures on the process of receiving label claims against public health, wood destroying, and invasive
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species pests, equivalent to about $17,000 in savings per data package submitted to the Agency and about $5,500 per registrant in annual savings I have therefore concluded that this action will relieve regulatory burden for all directly regulated small entities. The basis for this determination is presented in the small entity analysis prepared as part of the cost analysis for the proposed rule Ref. 1, which is summarized in Unit I.E, and a copy is available in the docket for this rulemaking. We have therefore concluded that this action will relieve regulatory burden for all directly regulated small entities.
D. Unfunded Mandates Reform Act UMRA
This action does not contain an unfunded mandate as described in UMRA, 2 U.S.C. 15311538, and will not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local or tribal governments. The proposed rule would primarily affect the private sector, i.e., pesticide registrants. The rule is not expected to result in expenditures by State, local, and Tribal governments, in the aggregate, or by the private sector, of $100 million or more when adjusted annually for inflation in any one year. Accordingly, this proposed rule is not subject to the requirements of sections 202, 203, or 205 of UMRA. The cost analysis for this action is summarized in Unit I.E. and is available in the docket.
E. Executive Order 13132: Federalism This action does not have federalism implications as specified in Executive Order 13132 64 FR 43255, August 10, 1999, because it will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.
F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments This action does not have tribal implications as specified in Executive Order 13175 65 FR 67249, November 9, 2000, because it will not have substantial direct effects on tribal governments, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes. At present, no Tribal governments hold, or have applied for, a pesticide registration. Thus, Executive
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