[Federal Register: August 15, 2007 (Volume 72, Number 157)]
[Rules and Regulations]
[Page 45653-45656]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15au07-16]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2007-0220; FRL-8122-3]
Cis-isomer of 1-(3-chloroallyl)-3,5,7-triaza-1-azoniaadamantane
chloride (CAS Reg. No. 51229-78-8); Exemption from the Requirement of a
Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of cis-isomer of 1-(3-chloroallyl)-3,5,7-
triaza-1-azoniaadamantane chloride (CAS Reg. No. 51229-78-8) under 40
CFR 180.920 (growing crops) when used as an inert ingredient as a
preservative at 0.14% by weight (wt) or less of pesticide formulations.
Dow Chemical Company submitted a petition to EPA under the Federal
Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality
Protection Act of 1996 (FQPA), requesting an exemption from the
requirement of a tolerance.
DATES: This regulation is effective August 15, 2007. Objections and
requests for hearings must be received on or before October 15, 2007,
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: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2007-0220. To access the
[[Page 45654]]
electronic docket, go to http://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov web site to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either in the electronic docket at http://www.regulations.gov
, or, if only available in hard copy, at the OPP
Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from
8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays.
The Docket Facility telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Karen Angulo, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 306-0404; e-mail address: angulo.karen@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
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.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Access Electronic Copies of this Document?
In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr
.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. 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-2007-0220 in the
subject line on the first page of your submission. All requests must be
in writing, and must be mailed or delivered to the Hearing Clerk on or
before October 15, 2007.
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 that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2007-0220, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of December 17, 2003 (67 FR 70251) (FRL-
7336-4), EPA issued a notice pursuant to section 408 of the FFDCA, 21
U.S.C. 346a, as amended by the FQPA (Public Law 104-170), announcing
the filing of a pesticide petition (PP 3E6656) by Dow Chemical Company,
Building 1803, Midland, Michigan 48674. The petition requested that 40
CFR 180.920 be amended by establishing an exemption from the
requirement of a tolerance for residues of cis-isomer of 1-(3-
chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride. That notice
included a summary of the petition prepared by the petitioner. Dow
Chemical Company requested the use of cis-isomer of 1-(3-chloroallyl)-
3,5,7-triaza-1-azoniaadamantane chloride as a preservative at 0.14% by
weight or less in pesticide formulations. No comments were received in
response to the notice of filing.
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe.'' Section 408(c)(2)(A)(ii) of the FFDCA
defines ``safe'' to mean that ``there is a reasonable certainty that no
harm will result from aggregate exposure to the pesticide chemical
residue, including all anticipated dietary exposures and all other
exposures for which there is reliable information.'' This includes
exposure through drinking water and in residential settings, but does
not include occupational exposure. Section 408(b)(2)(C) of the FFDCA
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue....'' These provisions were added to the FFDCA by the
Food Quality Protection Act (FQPA) of 1996.
III. Risk Characterization and Conclusion.
Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed
the available scientific data and other relevant information in support
of this action and considered its validity,
[[Page 45655]]
completeness and reliability and the relationship of this information
to human risk. EPA has also considered available information concerning
the variability of the sensitivities of major identifiable subgroups of
consumers, including infants and children. The nature of the toxic
effects caused by cis-isomer of 1-(3-chloroallyl)-3,5,7-triaza-1-
azoniaadamantane chloride are discussed in this unit. EPA has
sufficient data to assess the hazards of and make a determination on
aggregate exposure for the chemical.The following provides a brief
summary of the risk assessment and conclusions for the Agency's review
of cis-isomer of 1-(3-chloroallyl)-3,5,7-triaza-1-azoniaadamantane
chloride. The full decision document for this action is available on
EPA's Electronic Docket at http://www.regulations.gov/ under docket
number EPA-HQ-OPP-2007-0220.
A. Human Health
The Agency reviewed the available information on cis-isomer of 1-
(3-chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride submitted by
the petitioner as well as additional information available to EPA and
the data evaluated in the 1995 Dowicil[reg]CTAC RED. The toxicity
database is sufficient for cis-isomer of 1-(3-chloroallyl)-3,5,7-
triaza-1-azoniaadamantane chloride. In laboratory animal studies
measuring acute toxicity, cis-isomer of 1-(3-chloroallyl)-3,5,7-triaza-
1-azoniaadamantane chloride is slightly toxic in acute inhalation and
oral toxicity studies. Dermal effects were observed in rabbits at close
to the limit dose (no observed adverse effect level of 1,000 milligram/
kilogram/day (mg/kg/day)) in a subchronic study, and in a dermal acute
toxicity study the LD50 was determined to be 923 mg/day. The
chemical was mutagenic in the in vitro Chinese hamster ovary cell HGPRT
(Hypoxanthine guanine phophoribosyl transferase)forward mutation assay
with activation, but was nonmutagenic without activation. It was
negative in two other mutagenicity studies. Developmental effects were
observed at or above the level of maternal toxicity (optic
malformations may be linked to genetic issues rather than exposure to
the chemical). Chronic toxicity studies are not available,
nevertheless, sufficient information is available in sub-chronic and
developmental toxicity studies.
B. Exposure Assessment
The potential for exposure to residues of cis-isomer of 1-(3-
chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride is adequately
characterized based on the chemical's non-persistent nature and ready
dissipation in the environment and the low use rate. Exposures from
residues in food and drinking water are expected to be minimal.
Residential exposure (inhalation and dermal) is also expected to be
minimal from the use of the chemical in pesticides considering the low
application rate. Residential exposures from non-pesticides uses are
not anticipated to be of concern considering the low dermal toxicity
findings. The Agency concludes dietary and residential exposures of
concern are not anticipated from the inert ingredient use of cis-isomer
of 1-(3-chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride
considering its non-persistent nature in the environment, low toxicity,
and the limitations imposed on its proposed use under 40 CFR 180.920 as
a preservative at 0.14% by weight (wt) or less of the pesticide
formulation.
C. Safety Factor for Infants and Children
Section 408 of the FFDCA provides that EPA shall apply an
additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the database on toxicity and exposure
unless EPA determines that a different margin of safety will be safe
for infants and children. Margins of safety are incorporated into EPA
risk assessments either directly through use of a MOE analysis or
through using uncertainty (safety) factors in calculating a dose level
that poses no appreciable risk to humans. The toxicity database is
sufficient for cis-isomer of 1-(3-chloroallyl)-3,5,7-triaza-1-
azoniaadamantane chloride and potential exposure is adequately
characterized based on the low use rate. In terms of hazard, there are
low concerns and no residual uncertainties regarding prenatal and/or
postnatal toxicity.
D. Cumulative Exposure
Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.'' Unlike other pesticides for
which EPA has followed a cumulative risk approach based on a common
mechanism of toxicity, EPA has not made a common mechanism of toxicity
finding as to cis-isomer of 1-(3-chloroallyl)-3,5,7-triaza-1-
azoniaadamantane chloride and any other substances, and the chemical
does not appear to produce a toxic metabolite produced by other
substances. For the purposes of this tolerance action, therefore, EPA
has not assumed that cis-isomer of 1-(3-chloroallyl)-3,5,7-triaza-1-
azoniaadamantane chloride has a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative
.
E. Other Considerations
1. Analytical methods. Adequate enforcement methodology is
available to enforce the tolerance exemption expression. The method may
be requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone
number: (410) 305-2905; e-mail address: residuemethods@epa.gov.
Residues are not expected because of the chemical's ready degradation
in the environment and the low amount that will be permitted in the
pesticide formulation (limited to 0.14% by weight (wt) or less).
2. International tolerances. The Agency is not aware of any country
requiring a tolerance for cis-isomer of 1-(3-chloroallyl)-3,5,7-triaza-
1-azoniaadamantane chloride (CAS Reg. No. 51229-78-8) nor have any
CODEX Maximum Residue Levels (MRLs) been established for any food crops
at this time.
F. Determination of Safety and Conclusions
Based on the information in this preamble, EPA concludes that there
is a reasonable certainty of no harm to the general population,
including infants and children, from aggregate exposure to residues of
cis-isomer of 1-(3-chloroallyl)-3,5,7-triaza-1-azoniaadamantane
chloride. Accordingly, EPA finds that exempting cis-isomer of 1-(3-
chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride from the
requirement of a tolerance will be safe. EPA is establishing a
tolerance exemption in 40 CFR 180.920 for cis-isomer of 1-(3-
chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride when it is used
as an inert ingredient as a preservative at 0.14% by weight or less in
pesticide formulations.
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IV. Statutory and Executive Order Reviews
This final rule establishes a tolerance exemption under section
408(d) of FFDCA 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 rule
has been exempted from review under Executive Order 12866, this rule is
not subject to Executive Order 13211, 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 final rule 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 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 section 408(d) of FFDCA, 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 final rule 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 section
408(n)(4) of FFDCA. 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 6,
2000) do not apply to this rule. In addition, This rule does not impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
V. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. 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 this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: August 3, 2007.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.920, is amended by adding alphabetically the inert
ingredient to read as follows:
Sec. 180.920 Inert ingredients used pre-harvest; exemptions from the
requirement of a tolerance.
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Inert ingredients Limits Uses
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* * * * * * *
Cis-isomer of 1-(3-chloroallyl)- Maximum of 0.14% Preservative
3,5,7-triaza-1-azoniaadamantane by weight of
chloride (CAS Reg. No. 51229-78- formulation
8)
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[FR Doc. E7-16055 Filed 8-14-07; 8:45 am]
BILLING CODE 6560-50-S