ACTION
Final Rule.
SUMMARY
This regulation establishes an exemption from the requirement of a
tolerance for residues of ethanesulfonic acid, 2-hydroxy- (CAS Reg. No.
107-36-8); ethanesulfonic acid, 2-hydroxy-, ammonium salt (CAS Reg. No.
57267-78-4); ethanesulfonic acid, 2-hydroxy-, sodium salt (CAS Reg. No.
1562-00-1); ethanesulfonic acid, 2-hydroxy-, potassium salt (CAS Reg. No.
1561-99-5); ethanesulfonic acid, 2-hydroxy-, calcium salt (CAS Reg. No.
10550-47-7); ethanesulfonic acid, 2-hydroxy-, magnesium salt (CAS Reg. No.
17345-56-1), and ethanesulfonic acid, 2-hydroxy-, zinc salt (CAS Reg. No.
129756-32-7) when used as inert ingredients (chelator, sequestrant and
conditioning agent) in pesticide formulations applied to growing crops and raw
agricultural commodities after harvest and applied to animals. Technology
Sciences Group Inc. (1150 18th St. NW., Suite 1000 Washington, DC 20036) on
behalf of Huntsman Corporation (8600 Gosling Rd., The Woodlands, TX 77381)
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act
(FFDCA), requesting establishment of an exemption from the requirement of a
tolerance. This regulation eliminates the need to establish a maximum
permissible level for residues of ethanesulfonic acid, 2-hydroxy- and its
corresponding ammonium, sodium, potassium, calcium, magnesium, and zinc
salts.
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. Petition for Exemption
III. Inert Ingredient Definition
IV. Aggregate Risk Assessment and Determination of Safety
A. Toxicological Profile
B. Toxicological Points of Departure/Levels of Concern
C. Exposure Assessment
D. Safety Factor for Infants and Children
E. Aggregate Risks and Determination of Safety
V. Analytical Enforcement Methodology
VI. Conclusions
VII. Statutory and Executive Order Reviews
VIII. Congressional Review Act
List of Subjects in 40 CFR Part 180
PART 180—[AMENDED]
TABLES
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Table 1—Summary of Toxicological Doses and Endpoints for Isethionic Acid
and Its Salts for Use in Human Risk Assessment
DATES:
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This regulation is effective July 29, 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-2014-0325, 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 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-2014-0325 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-2014-0325, 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
informat
