[Federal Register: August 29, 2007 (Volume 72, Number 167)]
[Proposed Rules]
[Page 49689-49692]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29au07-20]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2007-0182; FRL-8143-3]
Dibasic Esters (CAS Reg. No. 95481-62-2); Proposed Pesticide
Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: This document proposes to establish an exemption from the
requirement of a tolerance for residues of dibasic esters (DBE; CAS
Reg. No. 95481-62-2) under 40 CFR 180.1277 when used as an inert
ingredient solvent material/anti-freeze microencapsulated at 10%
weight/weight (W/W) or less in pesticide formulations with the active
ingredient cyfluthrin. Whitmire Micro-Gen Research Laboratories, Inc.
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.
New data were received by EPA after the publication of the petitoner's
Notice of Filing, therefore, EPA is providing the public with an
additional opportunity to comment on the petitioner's request in this
proposed rule.
DATES: Comments must be received on or before October 29, 2007.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2007-0182, 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.
Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2007-0182. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The Federal regulations.gov website is an ``anonymous access''
system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an e-mail comment directly to EPA without going through
regulations.gov, your e-mail address will be automatically captured and
included as part of the comment that is placed in the docket and made
available on the Internet. If you submit an electronic comment, EPA
recommends that you include your name and other contact information in
the body of your comment and with any disk or CD-ROM you submit. If EPA
cannot read your comment due to technical difficulties and cannot
contact you for clarification, EPA may not be able to consider your
comment. Electronic files should avoid the use of special characters,
any form of encryption, and be free of any defects or viruses.
Docket: All documents in the docket are listed in the docket index
available in regulations.gov. To access the 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. Although
listed in the index, some information is not publicly available, e.g.,
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 Building), 2777 S. Crystal Drive, Arlington, VA.
The hours of operation of this Docket Facility are from 8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays. The Docket
telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Tracy Ward, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave, NW., Washington, DC 20460-0001; telephone
number: (703) 308-9361; e-mail address: ward.tracyh@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. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in Unit II. 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. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as
CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the
[[Page 49690]]
public docket. Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
II. Background and Statutory Findings
In the Federal Register of December 23, 1998 (63 FR 71126) (FRL-
6047-7), EPA issued a notice under section 408(d)(3) of the FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
5E4442) by Whitmire Micro-Gen Research Laboratories, Inc., 3568 Tree
Court Industrial Blvd., St. Louis, MO 63122-6682. The petition
requested that 40 CFR 180.910 and 180.930 be amended by establishing a
tolerance for residues of the inert ingredient DBE. This notice
included a summary of the petition prepared by Whitmire Micro-Gen
Research Laboratories, Inc., the petitioner. There were no comments
received in response to the notice of filing.
The typical process used by EPA in considering new tolerance
exemptions for inert ingredients is to publish the petition for public
comment in a Notice of Filing, evaluate the available data and
information on the chemical, and publish a final rule in the Federal
Register if the Agency concludes that a tolerance exemption can be
established. In the case of DBE, a significant number of new studies on
DBE were received by EPA after the publication of the Notice of Filing
[see the Federal Register of August 5, 1999 (64 FR 42692)] in which the
Agency issued a testing consent order incorporating an enforceable
consent agreement (ECA) under section 4 of the Toxic Substance Control
Act (TSCA). EPA reviewed the new data [see the Federal Register of
August 17, 2005 (70 FR 48418)] and considered the study results in
evaluating this petition. The Agency and the U.S. Consumer Product
Safety Commission (CPSC) agreed that all testing requirements were
completed, and that a third testing phase (in vivo dermal penetration
rate testing) was unnecessary. Considering this new data were not part
of the December 23, 1998 Notice of Filing, EPA is providing the public
with an additional opportunity to comment on the petitioner's request
to establish a tolerance exemption for DBE by proposing to establish a
tolerance exemption for DBE in this document.
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish an
exemption from the requirement of 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(b)(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....''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.
III. Risk Characterization and Conclusions
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, 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 the dibasic esters (DBE) are discussed in this unit. EPA has
sufficient data to assess the hazards of, and to make a determination
on, aggregate exposure for this chemical.
The following provides a brief summary of the risk assessment and
conclusions for the Agency's review of DBE. 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-2007-0182.
A. Human Health
The Agency reviewed the information submitted by the petitioner as
well as additional information available to the Agency and has
determined that DBE has low acute oral and inhalation toxicity and low
subchronic oral toxicity with a no observed adverse effect level
(NOAEL) of 842 mg/kg/day. In acute eye toxicity studies on the rabbit,
DBE had mild to moderate eye irritation. In subchronic inhalation
studies, DBE had a systemic inhalation NOAEL >= 0.40 mg/L (400
milligrams/milliliter (mg/m3)), but a nasal irritation NOAEL
< 0.02 mg/L (20 mg/m3). DBE did not induce neurotoxicity or
carcinogenicity in the studies reviewed, and it was negative for
mutagenicity in most tests, but positive for chromosomal aberrations
under activated conditions. In a repeat-dose inhalation reproduction
toxicity study, DBE had a NOAEL of 0.40 mg/L (400 mg/m3) and
a Lowest effect level (LEL) of 1.0 mg/L (1,000 mg/m3) based
on decreased pup weights at weaning. In repeat-dose inhalation exposure
studies, developmental toxicity was observed at higher doses (1.0 mg/L
or 1,000 mg/m3) than maternal toxicity (0.16 mg/L or 160 mg/
m3).
In studies, DBE did not cause dermal irritation in animals exposed
for four hours, but caused severe irritation (severe erythema and mild
edema) in one animal and reversible mild to moderate irritation in
animals exposed to DBE for 24 hours. DBE was not considered to be a
skin-sensitizer in guinea pigs. In repeat-dermal exposure studies
conducted on the rat, DBE had a systemic dermal NOAEL of 1,000 mg/kg/
day, and dermal irritation lowest observed adverse effect level (LOAEL)
of 100 mg/kg/day based on the slight, but reversible, erythema and
edema.
[[Page 49691]]
B. Exposure Assessment
The use of DBE in pesticide products is being limited to 10% or
less of microencapsulated pesticide formulations with the insecticide
active ingredient cyfluthrin. Uses of cyfluthrin are currently limited
to food-use applications such as spot and crack and crevice treatments
in food processing plants and food storage areas, and it is typically
applied by commercial applicators. Dietary exposures of concern from
residues in food and drinking water are not anticipated. The
microencapsulated formulation and its restriction to use with one
active ingredient will reduce the potential for residential exposures
(inhalation and dermal) to a minimal level. DBE is also used in non-
pesticide consumer products such as paint solvents. The use of DBE as
an inert ingredient in pesticide formulations, with the above
limitations, is not expected to contribute significantly to exposures
from its use in non-pesticide consumer products.
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 DBE 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 DBE 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 DBE 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 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 low amount that will be
permitted in the pesticide formulation (limited to 10% W/W or less) and
the limitation of use with one pesticide active ingredient.
2. International tolerances. The Agency is not aware of any country
requiring a tolerance for DBE, 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
DBE. Accordingly, EPA finds that exempting DBE from the requirement of
a tolerance will be safe.
IV. Conclusion
A tolerance exemption is proposed for residues of DBE when it is
used as an inert ingredient solvent material/anti-freeze
microencapsulated at 10% W/W or less in pesticide formulations with the
active ingredient cyfluthrin.
V. Statutory and Executive Order Reviews
This action proposes to establish a tolerance exemption under
section 408(d) of the 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 proposed rule has been exempted from review under Executive Order
12866 due to its lack of significance, this proposed 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). This proposed rule does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., or 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). 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);
or OMB review or any Agency action under Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997). 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 104-13, section 12(d) (15 U.S.C. 272 note). Pursuant to the
Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency
hereby certifies that this proposed action will not have significant
negative economic impact on a substantial number of small entities.
Establishing a pesticide tolerance or an exemption from the requirement
of a pesticide tolerance is, in effect, the removal of a regulatory
restriction on pesticide residues in food and thus such an action will
not have any negative economic impact on any entities, including small
entities. In addition, the Agency has determined that this action will
not have a substantial direct effect on 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,
as specified in Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999). Executive Order 13132 requires EPA to develop
an accountable process to ensure ``meaningful and timely input by State
and local officials in the development of regulatory policies that have
federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive order to include regulations
that 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
[[Page 49692]]
levels of government.'' This proposed rule directly regulates growers,
food processors, food handlers and food retailers, not States. This
action does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of the FFDCA. For these same reasons, the Agency
has determined that this proposed rule does not have any ``tribal
implications'' as described in Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive Order 13175, requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by tribal officials in the development of regulatory policies that have
tribal implications.'' ``Policies that have tribal implications'' is
defined in the Executive order to include regulations that have
``substantial direct effects on one or more Indian tribes, 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.'' This proposed rule will not have
substantial direct effects on tribal governments, on the relationship
between the Federal Government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this proposed rule.
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 20, 2007.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR chapter I be amended as
follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.1277 is added to subpart D to read as follows:
Sec. 180.1277 Dibasic esters; Exemption from the requirement of a
tolerance.
Dibasic esters (CAS Reg. No. 95481-62-2) is exempted from the
requirement of a tolerance for residues when used as an inert
ingredient (solvent material/anti-freeze) at 10% W/W or less in
microencapsulated pesticide formulations with the active ingredient
cyfluthrin.
[FR Doc. E7-17109 Filed 8-28-07; 8:45 am]
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