[Federal Register Volume 68, Number 172 (Friday, September 5, 2003)]
[Rules and Regulations]
[Pages 52695-52700]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-22546]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0284; FRL-7323-7]


Propylene Carbonate; Exemption from the Requirement of a 
Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of propylene carbonate when used as an 
inert ingredient in pesticide formulations applied pre- and post-
harvest to agricultural commodities. Huntsman Corporation submitted a 
petition to EPA under the Federal Food, Drug, and Cosmetic Act, as 
amended by the Food Quality Protection Act of 1996, requesting an 
exemption from the requirement of a tolerance. This regulation 
eliminates the need to establish a maximum permissible level for 
residues of propylene carbonate.

DATES: This regulation is effective September 5, 2003. Objections and 
requests for hearings, identified by docket ID number OPP-2003-0284, 
must be received on or before November 4, 2003.

ADDRESSES: Written objections and hearing requests submitted 
electronically, by mail, or through hand delivery/courier. Follow the 
detailed instructions as provided in Unit VIII. of the SUPPLEMENTARY 
INFORMATION.

FOR FURTHER INFORMATION CONTACT: Kathryn Boyle, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-6304; e-mail address:[email protected].

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:
    [sbull] Crop production (NAICS 111)
    [sbull] Animal production (NAICS 112)
    [sbull] Food manufacturing (NAICS 311)
    [sbull] Pesticide manufacturing (NAICS 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 underFOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket identification (ID) number OPP-2003-0284. The 
official public docket consists of the documents specifically 
referenced in this action, any public comments received, and other 
information related to this action. Although a part of the official 
docket, the public docket does not include Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. The official public docket is the collection of materials 
that is available for public viewing at the Public Information and 
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 
1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open 
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The docket telephone number is (703) 305-5805.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings athttp://www.epa.gov/fedrgstr/. A frequently updated 
electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a 
beta site currently under development.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still

[[Page 52696]]

access any of the publicly available docket materials through the 
docket facility identified in Unit I.B.1. Once in the system, select 
``search,'' then key in the appropriate docket ID number.

II. Background and Statutory Findings

    In the Federal Register of December 30, 1998 (63 FR 71920) (FRL-
6050-1), EPA issued a notice pursuant to section 408 of the Federal 
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the 
Food Quality Protection Act (FQPA) (Public Law 104-170), announcing the 
filing of a pesticide tolerance petition (PP 8E4992) by Huntsman 
Corporation, Houston, Texas. This notice included a summary of the 
petition prepared by the petitioner Huntsman. There were no comments 
received in response to the notice of filing.
    The petition requested that 40 CFR 180.1001(c) be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of propylene carbonate, also known as 1,3-Dioxolan-2-one, 4-
methyl- (CAS Reg. No. 108-32-7).
    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(b)(2)(A)(ii) 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) 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. First, EPA determines the 
toxicity of pesticides. Second, EPA examines exposure to the pesticide 
through food, drinking water, and through other exposures that occur as 
a result of pesticide use in residential settings.

III. Human Health Assessment

A. Toxicological Profile

    Consistent with section 408(b)(2)(D) of 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 
propylene carbonate are discussed in this unit. The Agency has reviewed 
12 toxicity studies using propylene carbonate as the test substance. 
The results of those reviews are listed in the following Table 1:

          Table 1.--Toxicity Studies Using Propylene Carbonate
------------------------------------------------------------------------
                Study Type                             Results
------------------------------------------------------------------------
Acute oral (rat)                            LD50 > 5,000 mg/kg
                                            (Toxicity Category IV)
------------------------------------------------------------------------
Acute dermal (rabbit)                       LD50 > 2,000 mg/kg
                                            (Toxicity Category III)
------------------------------------------------------------------------
Primary eye irritation (rabbit)             Not a significant ocular
                                             irritant (Toxicity Category
                                             III)
------------------------------------------------------------------------
Primary dermal irritation                   (Toxicity Category IV)
------------------------------------------------------------------------
Developmental (rat)                         Maternal NOAEL = 1,000 mg/kg/
                                             day
                                            Maternal LOAEL = 3,000 mg/kg/
                                             day based on mortality,
                                             clinical signs and
                                             decreased food consumption
                                            Developmental NOAEL = 3,000
                                             mg/kg/day
                                            Developmental LOAEL = 5,000
                                             mg/kg/day based on increase
                                             in skeletal variations
------------------------------------------------------------------------
113-week feeding (rat)                      NOAEL = equal to or greater
                                             than 5,000 mg/kg/day
                                            (HTD - highest dose tested)
                                            LOAEL = would be greater
                                             than 5,000 mg/kg/day
------------------------------------------------------------------------
113-week inhalation (rat) with neurotox     NOAEL = 0.5 mg/L/day
                                            LOAEL = 1.0 mg/L/daybased on
                                             clinical signs in both
                                             sexes
                                            No evidence of
                                             neurotoxicpotential
------------------------------------------------------------------------
Cancer dermal (skin-painting) (mouse)       Negative, but dosing was
                                             considered inadequate
------------------------------------------------------------------------
9-day inhalation (rat)                      NOAEL = not determined -
                                             effects seen at lowest dose
                                             tested
                                            LOAEL = 1 mg/L/day based on
                                             clinical signs of
                                             toxicity,ocular irritation
------------------------------------------------------------------------
Mouse micronucleus                          Not mutagenic
------------------------------------------------------------------------
UDS                                         Negative
------------------------------------------------------------------------
Gene mutation(S. typhimurium)               Negative
------------------------------------------------------------------------

B. Structure Activity Relationship Assessment

    For propylene carbonate, toxicity was assessed, in part, by a 
process called structure-activity-relationship (SAR). In this process, 
the chemical's structural similarity to other chemicals (for which data 
are available) is used to determine toxicity. For human health, this 
process, can be used to assess absorption and metabolism, mutagenicity, 
carcinogenicity, developmental and reproductive effects, neurotoxicity, 
systemic effects, immunotoxicity, and sensitization and irritation. 
This is a qualitative assessment using terms such as good, not likely, 
poor, moderate, or high.
    For propylene carbonate the SAR assessment determined that the 
chemical was not structurally related to any known carcinogens. The 
following human exposures were examined as part of the analysis: 
Inhalation, dermal, exposures to the eyes, and drinking water. 
Absorption of propylene carbonate is expected to be good (well-
absorbed) via all routes (oral, dermal and inhalation) based on 
physical/chemical properties. There are concerns for effects on the 
liver and kidneys, solvent-type neurotoxicity and developmental 
toxicity at high dose levels, and irritation to mucous

[[Page 52697]]

membranes. The overall SAR rating for human health is low/moderate 
concern.
    The SAR did note a concern for solvent neurotoxicity, i.e., 
neurotoxic effects that can occur due to ``high'' and/or ``prolonged'' 
dermal and inhalation exposures to organic solvents. It should be noted 
that the inclusion of the phrase ``solvent-type neurotoxicity'' in the 
SAR assessment does not necessarily indicate chemical-specific 
concerns. By including this statement those performing the SAR 
assessment are acknowledging that the chemical is a member of a class 
of chemicals that can exhibit solvent neurotoxicity.

C. Conclusions

    The Agency used two sources of information to determine the 
toxicity of propylene carbonate: The 12 toxicity studies submitted by 
the petitioner and reviewed by the Agency, and a SAR assessment. The 
two sources of data support each other. However, results of the SAR 
Assessment are a type of predicted data based in part on surrogate 
data. There is actual data generated using propylene carbonate as the 
test substance, and actual data has precedence over predicted data.
    The Agency reviewed a propylene carbonate developmental toxicity 
study in the rat with a maternal no observed adverse effect level 
(NOAEL) of 1,000 milligrams/kilogram/day (mg/kg/day) and a maternal 
lowest observed adverse effect level (LOAEL) of 3,000 mg/kg/day based 
on mortality, clinical signs and decreased food consumption. In the 
same study, the developmental NOAEL is 3,000 mg/kg/day and the 
developmental LOAEL is 5,000 mg/kg/day based on an increase in skeletal 
variations. In a propylene carbonate 13-week rat feeding study the 
NOAEL is equal to or greater than 5,000 mg/kg/day, the highest dose 
tested. A LOAEL was not identified in that study, but it would be even 
greater than 5,000 mg/kg/day. It is noted that each of these NOAELs is 
equal to or greater than 1,000 mg/kg/day. As a matter of practice, for 
both the developmental and the 13-week toxicity study, the Agency does 
not encourage testing above 1,000 mg/kg/day. The lack of effects at 
1,000 mg/kg/day is considered adequate to define the toxicity, without 
pushing the dose levels higher until effects are apparent.
    The SAR assessment judged propylene carbonate to be of low/moderate 
concern. It did not identify any carcinogenic concerns. One identified 
concern was for possible irritation to mucous membranes. This concern 
would involve the dermal and inhalation exposure routes and would be 
addressed through the use of protective equipment such as gloves and 
respirators, not through establishment of tolerance exemptions.
    A concern predicted by the SAR, based on its structural chemistry 
and chemical class, is for possible solvent neurotoxicity from exposure 
to propylene carbonate. As previously explained, this statement 
acknowledges that propylene carbonate is a member of a class of 
chemicals that can exhibit solvent neurotoxicity. However, the 
propylene carbonate data base includes a 13-week inhalation toxicity 
study in the rat with a neurotoxicity evaluation. Based on its review 
and evaluation of this inhalation toxicity study, the Agency determined 
that there was no evidence of neurotoxicity potential.
    The SAR also indicated a concern for developmental toxicity at high 
dose levels. However, the Agency reviewed a propylene carbonate 
developmental toxicity study in the rat with a maternal NOAEL of 1,000 
mg/kg/day and a maternal LOAEL of 3,000 mg/kg/day based on mortality, 
clinical signs and decreased food consumption. In the same study, the 
developmental NOAEL is 3,000 mg/kg/day and the developmental LOAEL is 
5,000 mg/kg/day based on increase in skeletal variations.
    Considering the NOAELs of greater than 1,000 mg/kg/day for the 
propylene carbonate toxicity studies and the overall judgement of low/
moderate concern from the SAR assessment, propylene carbonate is of low 
toxicological concern.

IV. Aggregate Exposures

    In examining aggregate exposure, FFDCA section 408 directs EPA to 
consider available information concerning exposures from the pesticide 
residue in food and all other non-occupational exposures, including 
drinking water from ground water or surface water and exposure through 
pesticide use in gardens, lawns, or buildings (residential and other 
indoor uses).
    Over 1 million pounds of propylene carbonate are either produced or 
imported per year. Some of this propylene carbonate production is used 
as a chemical intermediate, in the production of other chemicals. 
Propylene carbonate has been approved by the Food and Drug 
Administration for use as an indirect food additive as a component of 
adhesives. According to 21 CFR 175.105, propylene carbonate can be a 
component of an adhesive used as part of ``articles intended for use in 
packaging, transporting, or holding food.'' Propylene carbonate is also 
used in cosmetics. Information on the internet (Huntsman website) 
indicates that propylene carbonate is used in tub and tile cleaners, 
hard surface and floor cleaners that could be used in and around the 
home.
    The Agency has used various screening-level models to estimate some 
of the existing levels of exposure, and those that could occur as a 
result of establishing this tolerance exemption. To assure 
protectiveness, these estimates are deliberately intended to over-
estimate exposure as shown in the following Table 2:

    Table 2.--Screening-Levels of Exposure Using Propylene Carbonate
------------------------------------------------------------------------
             Type of Exposure                      Exposure Level
------------------------------------------------------------------------
Dietary - Food (as a result of application  Acute exposure: Less than 1
 to crops)                                   mg/kg/day at 95th
                                             percentile
                                            chronic exposure: Less than
                                             1 mg/kg/day
------------------------------------------------------------------------
Dietary - Drinking Water                    Acute exposure: Much less
                                             than 1 mg/kg/day
                                            Chronic exposure: Much less
                                             than 1 mg/kg/day
------------------------------------------------------------------------
Residential (as a result of using a         Approximately 6 mg/kg/day
 cleaning product)
------------------------------------------------------------------------
Residential (as a result of using a         Approximately 1 mg/kg/day
 laundry detergent)
------------------------------------------------------------------------
Residential (as a result of application to  Less than 1 mg/kg/day
 a lawn)
------------------------------------------------------------------------

    With one exception all of the screening-level exposure estimates 
are in the range of or less than 1 mg/kg/day. The existing studies for 
propylene carbonate yielded NOAELs that were equal to or greater than 
1,000 mg/kg/day. The screening-level exposure estimates are orders of 
magnitude lower than these NOAELs. Even considering the reported uses, 
the use of propylene carbonate as an inert ingredient should result in 
human exposure far below any dose level that could possibly produce an 
adverse effect.

V. Cumulative Effects from Substances with a Common Mechanism of 
Toxicity

    Section 408(b)(2)(D)(v) of the FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency

[[Page 52698]]

consider``available information'' concerning the cumulative effects of 
a particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine 
whether propylene carbonate has a common mechanism of toxicity with 
other substances. 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 propylene 
carbonate and any other substances and propylene carbonate 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 propylene carbonate 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 the policy statements 
released by EPA's Office of Pesticide Programs concerning common 
mechanism determinations and procedures for cumulating effects from 
substances found to have a common mechanism on EPA's website athttp://www.epa.gov/pesticides/cumulative/.

VI. Determination of Safety for U.S. Population, Infants and Children

    Based on the available data, the SAR assessment indicating low/
moderate concern and the data submitted by the petitioner, Huntsman 
Corporation, which indicate that the chemical is of low toxicological 
concern, EPA concludes that propylene carbonate does not pose a dietary 
risk under reasonably foreseeable circumstances. Accordingly, EPA finds 
that there is a reasonable certainty that no harm will result to the 
general population, and to infants and children from aggregate exposure 
to propylene carbonate. Due to the expected low oral toxicity, a safety 
factor analysis has not been used to assess the risk. For the same 
reasons and especially considering the developmental toxicity NOAEL, 
the additional tenfold safety factor for the protection of infants and 
children is unnecessary.
    Based on the information in this preamble, EPA concludes that there 
is a reasonable certainty of no harm from aggregate exposure to 
residues of 1,3-Dioxolan-2-one, 4-methyl- (propylene carbonate). 
Accordingly, EPA finds that exempting 1,3-Dioxolan-2-one, 4-methyl-
(propylene carbonate) (CAS Reg. No. 108-32-7) from the requirement of a 
tolerance will be safe.

VII. Other Considerations

A. Endocrine Disruptors

    FQPA requires EPA to develop a screening program to determine 
whether certain substances, including all pesticide chemicals (both 
inert and active ingredients), ``may have an effect in humans that is 
similar to an effect produced by a naturally occurring estrogen, or 
such other endocrine effect. . .'' EPA has been working with interested 
stakeholders to develop a screening and testing program as well as a 
priority setting scheme. As the Agency proceeds with implementation of 
this program, further testing of products containing propylene 
carbonate for endocrine effects may be required.

B. Analytical Method(s)

    An analytical method is not required for enforcement purposes since 
the Agency is establishing an exemption from the requirement of a 
tolerance without any numerical limitation.

C. Existing Tolerances

    There are no existing tolerances or tolerance exemptions for 
propylene carbonate.

D. International Tolerances

    The Agency is not aware of any country requiring a tolerance for 
propylene carbonate nor have any CODEX Maximum Residue Levels been 
established for any food crops at this time.

E. List 4A (Minimal Risk) Classification

    The Agency established 40 CFR 180.950 (see the rationale in the 
proposed rule published January 15, 2002 (67 FR 1925) (FRL-6807-8)) to 
collect the tolerance exemptions for those substances classified as 
List 4A, i.e., minimal risk substances. As part of evaluating an inert 
ingredient and establishing the tolerance exemption, the Agency 
determines the chemical's list classification.
    The available data and the SAR assessment indicated propylene 
carbonate is of lower toxicity. Given the NOAELs of greater than 1,000 
mg/kg/day and the acute toxicity studies that were category III and IV, 
it has been determined that propylene carbonate, also known as 1,3-
Dioxolan-2-one, 4-methyl- (CAS Reg. No. 108-32-7) is to be classified 
as a List 4A inert ingredient. Thus, the tolerance exemption will be 
established in 40 CFR 180.950 instead of 40 CFR 180.1001(c) as 
requested by the petitioner, Huntsman.

VIII. Conclusions

    Based on the information in the record, summarized in this 
preamble, EPA concludes that there is a reasonable certainty of no harm 
from aggregate exposure to residues of propylene carbonate (CAS Reg. 
No. 108-32-7). Accordingly, EPA finds that exempting propylene 
carbonate from the requirement of a tolerance will be safe.

IX. Objections and Hearing Requests

    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. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) provides essentially 
the same process for persons to ``object '' to a regulation for an 
exemption from the requirement of a tolerance issued by EPA under new 
section 408(d), as was provided in the old FFDCA sections 408 and 409. 
However, the period for filing objections is now 60 days, rather than 
30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID numberOPP-2003-0284 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 November 4, 2003.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in

[[Page 52699]]

40 CFR part 2. A copy of the information that does not contain CBI must 
be submitted for inclusion in the public record. Information not marked 
confidential may be disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900C), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Rm. 104, Crystal Mall 2, 1921 
Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is 
open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Office of the Hearing Clerk is 
(703) 603-0061.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit IX.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.1. Mail your 
copies, identified by docket ID number OPP-2003-0284, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in Unit I.B.1. You may also send an electronic copy of 
your request via e-mail to:[email protected]. Please use an ASCII file 
format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

X. Statutory and Executive Order Reviews

    This final rule establishes an exemption from the tolerance 
requirement under FFDCA section 408(d) 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 due to its lack of significance, 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). 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., 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 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under FFDCA section 408(d), such as the exemption 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. 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, entitledFederalism 
(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 levels of 
government.'' This final 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 FFDCA section 408(n)(4). For these same reasons, the Agency has 
determined that this 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

[[Page 52700]]

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 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 rule.

XI. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
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 theFederal 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 22, 2003.
Peter Caulkins,
Acting 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), 346(a) and 371.

0
2. Section 180.950 is amended by adding alphabetically the following 
ingredient to the table in paragraph (e) to read as follows.


Sec.  180.950  Tolerance exemptions for minimal risk active and inert 
ingredients.

* * * * *
    (e) * * *

 
----------------------------------------------------------------------------------------------------------------
                          Chemical                                                 CAS No.
----------------------------------------------------------------------------------------------------------------
                                                    * * * * *
1,3-Dioxolan-2-one, 4-methyl-(propylene carbonate).........                                             108-32-7
                                                    * * * * *
----------------------------------------------------------------------------------------------------------------


[FR Doc. 03-22546 Filed 9-4-03; 8:45am]
BILLING CODE 6560-50-S