Document ID: EPA-HQ-OPP-2007-0182-0001
Agency: epa
Document Type: Proposed Rule
Title: Dibasic Esters (CAS Reg. No. 95481-62-2); Proposed Pesticide Tolerance Exemption
Posted Date: 2007-08-29T04:00Z

[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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