ACTION
Final Rule.
SUMMARY
This regulation establishes tolerances for residues of benalaxyl-M in or
on grape and tomato. Since there are currently no U.S. registrations of
benalaxyl-M for use on grape and tomato, this tolerance will allow the import of
grape and tomato containing residues of benalaxyl-M. Technology Sciences Group,
on behalf of Isagro S.p.A, requested these tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
TABLE OF CONTENTS
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DATES:
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
B. How can I get electronic access to other related information?
C. How can I file an objection or hearing request?
II. Summary of Petitioned-for Tolerance
III. Aggregate Risk Assessment and Determination of Safety
A. Toxicological Profile
B. Toxicological Points of Departure/Levels of Concern
Table—Summary of Toxicological Doses and Endpoints for Benalaxyl-M for
Use in Human Health Risk Assessment
C. Exposure Assessment
D. Safety Factor for Infants and Children
E. Aggregate Risks and Determination of Safety
IV. Other Considerations
A. Analytical Enforcement Methodology
B. International Residue Limits
C. Revisions to Petitioned-for Tolerances
V. Conclusion
VI. Statutory and Executive Order Reviews
VII. Congressional Review Act
List of Subjects in 40 CFR Part 180
PART 180—[AMENDED]
TABLES
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Table 4.5.4.—Summary of Toxicological Doses and Endpoints for Benalaxyl-M
for Use in Dietary Human Health Risk Assessments
DATES:
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This regulation is effective July 30, 2015. Objections and requests for
hearings must be received on or before September 28, 2015, and must be filed in
accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C.
of the SUPPLEMENTARY INFORMATION).
ADDRESSES:
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The docket for this action, identified by docket identification (ID)
number EPA-HQ-OPP-2013-0714, is available at http://www.regulations.gov or at
the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the
Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson
Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001.
The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public Reading
Room is (202) 566-1744, and the telephone number for the OPP Docket is (703)
305-5805. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
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Susan Lewis, Registration Division (7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001; main telephone number: (703) 305-7090; email address: RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
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I. General Information
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A. Does this action apply to me?
You may be potentially affected by this action if you are an agricultural
producer, food manufacturer, or pesticide manufacturer. The following list of
North American Industrial Classification System (NAICS) codes is not intended to
be exhaustive, but rather provides a guide to help readers determine whether
this document applies to them. Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA‘s tolerance
regulations at 40 CFR part 180 through the Government Printing Office‘s e-CFR
site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
To access the OCSPP test guidelines referenced in this document electronically,
please go to http://www.epa.gov/ocspp and select “Test Methods and
Guidelines.”
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a hearing on
those objections. You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in 40 CFR part 178. To
ensure proper receipt by EPA, you must identify docket ID number
EPA-HQ-OPP-2013-0714 in the subject line on the first page of your submission.
All objections and requests for a hearing must be in writing, and must be
received by the Hearing Clerk on or before September 28, 2015. Addresses for
mail and hand delivery of objections and hearing requests are provided in 40 CFR
178.25(b).
In addition to filing an objection or hearing request with the Hearing
Clerk as described in 40 CFR part 178, please submit a copy of the filing
(excluding any Confidential Business Information (CBI)) for inclusion in the
public docket. Information not marked confidential pursuant to 40 CFR part 2 may
be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of
your objection or hearing request, identified by docket ID number
EPA-HQ-OPP-2013-0714, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions
for submitting comments. Do not submit electronically any information you
consider to be CBI or other information whose disclosure is restricted by
statute.
Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC),
(28221T), 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
Hand Delivery: To make special arrangements for hand delivery or delivery
of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along with
more information about dockets generally, is available