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Federal Register / Vol. 86, No. 179 / Monday, September 20, 2021 / Rules and Regulations population group of concern because no appropriate toxicological effect attributable to a single dose was observed for the general US population or any other population subgroup.
2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to pyraclostrobin from food and water will utilize 28% of the cPAD for all children 1 to 2 years old, the population group receiving the greatest exposure. Chronic residential exposure to residues of pyraclostrobin is not expected.
3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water considered to be a background exposure level.
Pyraclostrobin is currently registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to pyraclostrobin.
Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in an aggregate MOE of 430 for children 1 to 2 years old. Because EPAs level of concern for pyraclostrobin is a MOE of 100 or below, this MOE is not of concern.
4. Intermediate-term risk.
Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water considered to be a background exposure level.
A separate intermediate-term adverse effect was identified for pyraclostrobin.
However, pyraclostrobin is not registered for any use patterns that would result in intermediate-term residential exposures that can be combined with background dietary exposures. Because there is no intermediate-term residential aggregate exposures and chronic dietary exposure has already been assessed under the appropriately protective cPAD, no further assessment of intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediate-term risk for pyraclostrobin.
5. Aggregate cancer risk for U.S.
population. Pyraclostrobin is classified as Not Likely to Be Carcinogenic to Humans; therefore, EPA does not expect pyraclostrobin exposures to pose an aggregate cancer risk.
6. Determination of safety. Based on these risk assessments, EPA concludes
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that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to pyraclostrobin residues.
IV. Other Considerations A. Analytical Enforcement Methodology Two adequate methods are available for enforcement purposes for residues of pyraclostrobin and its metabolites in/on plant commodities: a liquid chromatography with tandem mass spectroscopy LC/MS/MS method BASF Method D9908 and a highperformance liquid chromatography/
ultraviolet HPLC/UV method Method D9904.
B. International Residue Limits In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits MRLs established by the Codex Alimentarius Commission Codex, as required by FFDCA section 408b4.
There is no Codex MRL for pyraclostrobin in or on pomegranate.
V. Conclusion Therefore, a tolerance is established for residues of pyraclostrobin in or on pomegranate at 0.3 ppm. Additionally, the Agency is putting back a footnote that states There is no U.S. registration on coffee, bean, green as of September 30, 2009 to the table in paragraph a1
that was inadvertently removed in 2013.
VI. Statutory and Executive Order Reviews This action establishes a tolerance under FFDCA section 408d in response to a petition submitted to the Agency. The Office of Management and Budget OMB has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review 58 FR 51735, October 4, 1993. Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use 66
FR 28355, May 22, 2001 or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks 62 FR 19885, April 23, 1997. This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act PRA 44
U.S.C. 3501 et seq., nor does it require
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any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations 59 FR 7629, February 16, 1994.
Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408d, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act RFA 5 U.S.C. 601 et seq., do not apply.
This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA
section 408n4. As such, the Agency has determined that this action will not have a substantial direct effect on States or Tribal Governments, on the relationship between the National Government and the States or Tribal Governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian Tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism 64 FR 43255, August 10, 1999 and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments 65 FR 67249, November 9, 2000 do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act UMRA 2 U.S.C. 1501 et seq..
This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12d of the National Technology Transfer and Advancement Act NTTAA 15 U.S.C. 272 note.
VII. Congressional Review Act CRA
Pursuant to the CRA 5 U.S.C. 801 et seq., EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S.
House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a major rule as defined by 5 U.S.C.
8042.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
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