3-Hexen-1-ol, (3Z)-; Exemption from the Requirement of a Tolerance, 31359-31365 [05-10846]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 70, Number 104 (Wednesday, June 1, 2005)]
[Rules and Regulations]
[Pages 31359-31365]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-10846]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2005-0028; FRL-7713-2]


3-Hexen-1-ol, (3Z)-; 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 -3-hexen-1-ol also known as leaf 
alcohol or 3-hexen-1-ol, (3Z)- (CAS Reg. No. 928-96-1) when used as an 
inert ingredient - an odorant or alerting agent in certain pesticide 
formulations. Syngenta Crop Protection, 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. This regulation 
eliminates the need to establish a maximum permissible level for 
residues of cis -3-hexen-1-ol.

DATES: This regulation is effective June 1, 2005. Objections and 
requests for hearings must be received on or before August 1, 2005.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit XII. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under Docket 
identification (ID) number OPP-2005-0028. All documents in the docket 
are listed in the EDOCKET index at https://www.epa.gov/edocket. Although 
listed in the index, some information is not publicly available, i.e., 
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 electronically 
in EDOCKET or in hard copy at the Public Information and Records 
Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 1801 S. 
Bell St., 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.

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:

[[Page 31360]]

 (703) 305-6304; e-mail address: boyle.kathryn@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 Get Electronic Documents and Other Related Information?

    In addition to using EDOCKET at (https://www.epa.gov/edocket/), you 
may access this Federal Register document electronically through the 
EPA Internet under the ``Federal Register'' listings at https://
www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 
CFR part 180 is available at E-CFR Beta Site Two at https://
www.gpoaccess.gov/ecfr/.

II. Background and Statutory Findings

    In the Federal Register of July 16, 2003 (68 FR 42035) (FRL-7316-
2), 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 3E6589) by Syngenta Crop Protection, 
Inc, Box 18300, Greensboro, NC 27419.
    The petition requested that 40 CFR part 180 be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of cis -3-hexen-1-ol which is also known as leaf alcohol or 3-
hexen-1-ol, (3Z)- (CAS Reg. No. 928-96-1). That notice included a 
summary of the petition prepared by Syngenta Crop Protection, Inc. The 
notice specifically requested a limited inert ingredient use pattern 
for cis -3-hexen-1-ol. The petitioner intends to use the cis-3-hexen-1-
ol as an odorant or alerting agent to warn pesticide handlers that a 
pesticide formulation had been or is being used. Syngenta, in that 
Notice, described their intent to use cis -3-hexen-1-ol in pesticide 
formulations containing the active ingredient paraquat dichloride and 
at a concentration not to exceed 4 grams/liter (g/L) in the formulated 
pesticide product.
    One comment was received in response to the notice of filing. The 
Agency's response to this comment is in Unit X.E.
    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) 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. 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. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active 
ingredients as defined in 40 CFR 153.125 and include, but are not 
limited to, the following types of ingredients (except when they have a 
pesticidal efficacy of their own): Solvents such as alcohols and 
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty 
acids; carriers such as clay and diatomaceous earth; thickeners such as 
carrageenan and modified cellulose; wetting, spreading, and dispersing 
agents; propellants in aerosol dispensers; microencapsulating agents; 
and emulsifiers. The term ``inert'' is not intended to imply 
nontoxicity; the ingredient may or may not be chemically active. 
Generally, EPA has exempted inert ingredients from the requirement of a 
tolerance based on the low toxicity of the individual inert 
ingredients.

IV. Physical/Chemical Properties

    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. The 
physical/chemical properties of cis-3-hexen-1-ol are given in this 
unit.
    Cis-3-Hexen-1-ol is a six carbon unsaturated alcohol with a 
molecular formula of C6H12O and a structural 
formula of 
CH3CH2CHCHCH2CH2OH. It is a 
colorless liquid with a pine needle or grassy odor. Cis-3-Hexen-1-ol is 
also referred to as leaf alcohol, because of its presence in the 
fragrance released by green leaves. The vapor pressure of cis-3-hexen-
1-ol is estimated as 0.86 millimeter (mm) mercury (Hg). It's solubility 
in water is greater than 10 g/L at 25[deg]C.

V. Toxicity Profile

    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-3-hexen-1-ol are discussed in this unit.

A. Structure Activity Relationship Assessment

    For cis-3-hexen-1-ol, 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 cis-3-hexen-1-ol the conclusions of the team performing the SAR 
assessment are as follows: Cis-3-hexen-1-ol is absorbed via all routes 
of exposure. There is concern for irritation to all tissues and 
neurotoxicity based on solvent properties of the material. A concern 
for liver toxicity based on cis-

[[Page 31361]]

3-hexen-1-ol's structural relationship to several long chain alcohols 
was noted. Various concerns based on the 98-day drinking water study 
(discussed below) are also noted. The overall rating for human health 
is low-moderate concern.
    Cis-3-Hexen-1-ol is not structurally related to any known mutagens, 
carcinogens or developmental/reproductive toxicants. 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 indication 
of concerns for solvent-type neurotoxicity in the SAR assessment does 
not necessarily indicate chemical-specific concerns. By including this 
statement, those performing the assessment are acknowledging that the 
chemical is a member of a class of chemicals that can exhibit solvent 
neurotoxicity.

B. Metabolism of cis-3-Hexen-1-ol

    The metabolism of alcohols such as cis-3-hexen-1-ol in the 
mammalian body is well-understood. The mammalian body would effectively 
metabolize the alcohol to the corresponding aldehyde, which would then 
be metabolized to the corresponding carboxylic acid. The mammalian body 
has well-understood pathways for metabolism of carboxylic acids to 
carbon dioxide and water.

C. Review of Data from Open Literature

    1. Acute toxicity. As shown in the following Table, rat and mouse 
lethal dose (LD)50 values range from 7.0 to 10.1 g/kilogram 
(kg).

                                                           Acute Toxicity of cis-3-Hexen-1-ol
--------------------------------------------------------------------------------------------------------------------------------------------------------
                  Species                                 Route                           Sex                          LD50 (95% C.I.) (g/kg)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Rat                                          Oral                                                Male (M)                                10.1 (8.4-12.1)
                                                                                               Female (F)                                  7.3 (5.6-9.5)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Mice                                         Oral                                                    Male                                  7.0 (5.0-9.6)
                                                                                                   Female                                  7.2 (5.8-9.3)
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Signs of toxicity in these oral studies included ataxia, lethargy 
and comatose-like state. Dermal LD50 values of greater than 
5,000 milligrams (mg)/kg have been reported for rabbits. No irritation 
was associated with a 24-hour dermal application of neat (undiluted) 
cis-3-hexen-1-ol with an occlusive dressing to either intact or abraded 
rabbit skin. Similarly, human subjects exhibited no signs or symptoms 
of irritation following a 48-hour dermal exposure to 4% cis-3-hexen-1-
ol (in petrolatum) under an occlusive patch. In maximization tests 
using human volunteers, there was no evidence of sensitization.
    2. Subchronic toxicity. In a 98-day drinking water study, 15 male 
and 15 female weanling rats were given cis-3-hexen-1-ol in drinking 
water at concentration levels of 0, 310, 1,250, or 5,000 parts per 
million (ppm). The dose levels were calculated as 0, 30, 127, or 410 
mg/kg/day (males); and 0, 42, 168, or 721 mg/kg/day (females). There 
were no effects on food consumption or body weight gain, and no 
indications of clinical toxicity. Reduced water intake was recorded for 
high-dose males, which was attributed to reduced palatability. Evidence 
of a renal effect was observed in high-dose males as shown by increased 
relative kidney weights and increased specific gravity of urine 
following water loading challenge. There were also increases in adrenal 
weights at the high-dose level. High-dose females exhibited transitory 
anemia (reduced hemoglobin concentration) during the 6th week of 
treatment. The 1,250 ppm or 127/168 mg/kg/day (M/F) is considered a no 
observed adverse effect level (NOAEL). The lowest observed adverse 
effect level (LOAEL) of 5,000 ppm is based on effects to the kidneys, 
blood and adrenal glands.

D. Conclusions

    The mammalian body effectively metabolizes alcohols such as cis-3-
hexen-1-ol to the corresponding aldehyde and then to the corresponding 
carboxylic acid.
    The SAR assessment did not identify any concerns for mutagenicity, 
carcinogenicity or developmental/reproductive toxicity. One of the 
concerns identified was for possible solvent neurotoxicity. Solvent 
neurotoxicity concerns usually stem from dermal and inhalation 
exposures. Exposures generally need to be ``high'' and/or ``prolonged'' 
for these solvent toxicity effects to occur. Also, for acute exposures, 
such effects, generally, are reversible. Concerns are for occupational 
exposures since the potential for day in/day out exposure can occur in 
the workplace. Such concerns are addressed through product labeling and 
the use of protective equipment such as gloves and respirators.
    Another SAR concern is for irritation to all tissues. However, 
acute dermal skin irritation and sensitization studies indicate no 
evidence of sensitization or irritation.
    Alcohols, in general, are considered to be hepatotoxic, i.e. 
impacting the liver. However, the target organs in the 98 day drinking 
water study were the kidneys, blood and adrenal glands. And, the 
reduced hemoglobin concentration was transitory, that is, the test 
animals recovered during the study.
    Thus, the mammalian body can effectively metabolize cis-3-hexen-1-
ol. It is not acutely toxic. The SAR assessment did not identify any 
concerns for mutagenicity, carcinogenicity or developmental/
reproductive toxicity. The NOAEL in the 98-day drinking water study is 
127/168 mg/kg/day (M/F).
    The petitioner has proposed to limit the use of cis-3-hexen-1-ol to 
a concentration not to exceed 4 g/L in the formulated pesticide 
product. This is equivalent to 0.4%. At this low percentage in the 
formulated product, the residues from the use of cis-3-hexen-1-ol as an 
inert ingredient, an odorant or alerting agent, will be much lower than 
the level at which an adverse effect could occur.

VI. Aggregate Exposures

    In examining aggregate exposure, section 408 of the FFDCA 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).
    EPA establishes exemptions from the requirement of a tolerance only 
in those cases where it can be clearly demonstrated that the risks from 
aggregate exposure to pesticide chemical residues under reasonably 
foreseeable circumstances will pose no appreciable risks to human 
health. In

[[Page 31362]]

order to determine the risks from aggregate exposure to pesticide inert 
ingredients, the Agency considers the toxicity of the inert in 
conjunction with possible exposure to residues of the inert ingredient 
through food, drinking water, and through other exposures that occur as 
a result of pesticide use in residential settings. If EPA is able to 
determine that a finite tolerance is not necessary to ensure that there 
is a reasonable certainty that no harm will result from aggregate 
exposure to the inert ingredient, an exemption from the requirement of 
a tolerance may be established.

A. Dietary Exposure

    1. Food. Cis-3-Hexen-1-ol is naturally-occurring in common food 
sources such as green leafy vegetables. In fact, low molecular weight 
alcohols, aldehydes, and acids such as cis-3-hexen-1-ol are ubiquitous 
in nature, in our foods as the flavors and fragrances which give foods 
their distinctive tastes. Such chemicals have been detected (at low 
levels) in almost every known fruit and vegetable. Given the natural 
occurrence, there is a background (naturally occurring) level of 
exposure to cis-3-hexen-1-ol, that cannot be regulated and cannot be 
decreased.
    Cis-3-Hexen-1-ol is also used as a direct food additive, a 
flavoring, under 21 CFR 172.515: Synthetic Flavoring Substances and 
Adjuvants. In its 1999 evaluation (Food Additives Series 42; see http:/
/www.inchem.org/documents/jecfa/jecmono/v042je16.htm.) of the safety of 
various linear and branched-chain aliphatic, unsaturated chemicals used 
as flavoring substances, the Joint FAO/WHO (Food and Agriculture 
Organization/World Health Organization) Expert Committee on Food 
Additives estimated the per capita intake of cis-3-hexen-1-ol when used 
as a food additive. In Europe, the estimate is 71 micrograms (ug)/kg/
day. In the US, the estimate is 18 ug/kg/day, or 0.018 mg/kg/day.
    Exposure resulting from the use of cis-3-hexen-1-ol at less than 
0.4% in the formulated product is anticipated to be much smaller than 
the naturally occurring background level of exposure, or exposure from 
its use as a flavoring agent.
    2. Drinking water exposure. The SAR assessment also estimated the 
fate properties of cis-3-hexen-1-ol. Based on these properties, the 
team performing the SAR judged that the potential for cis-3-hexen-1-ol 
to migrate to ground water as very small. The estimated water 
solubility of cis-3-hexen-1-ol is greater than 10 g/L. However, based 
on cis-3-hexen-1-ol's vapor pressure of 0.86 mm Hg, the Agency modeled 
a volatilization half-life of 39 hours in rivers and 21 days in lakes. 
Primary biodegradation begins rapidly, within days, as the cis-3-hexen-
1-ol is degraded to other chemicals. Based on biodegradation models and 
on the Agency's professional judgement, cis-3-hexen-1-ol is completely 
biodegraded to water and carbon dioxide in days to weeks. Given the 
lack of migration to ground water, the rapid biodegradation (i.e. lack 
of persistence), and the volatilization of cis-3-hexen-1-ol, 
significant concentrations of cis-3-hexen-1-ol are very unlikely in 
sources of drinking water.

B. Other Non-Occupational Exposure

    Cis-3-Hexen-1-ol has been used since the 1940s in soaps, 
detergents, and personal care products. Because it constitutes such a 
low percentage of the formulation, exposure is likely to be minimal.
    Cis-3-Hexen-1-ol is released to the atmosphere from deciduous, 
coniferous, and herbaceous vegetation, and also agricultural crops. 
These naturally-occurring emissions vary according to the season, and 
the maturity of the vegetation, which would include growth stages such 
as flowering. Again, this is a background (naturally occurring) level 
of exposure to cis-3-hexen-1-ol, that cannot be regulated and cannot be 
decreased.

VII. Cumulative Effects

    Section 408 (b)(2)(D)(v) of FFDCA requires that, when considering 
whether to establish, modify, or revoke a tolerance or tolerance 
exemption, the Agency consider ``available information'' concerning the 
cumulative effects of a particular chemical's residues and ``other 
substances that have a common mechanism of toxicity.''
    Unlike other pesticide chemicals 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-3-hexen-
1-ol and any other substances, and cis-3-hexen-1-ol 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-3-hexen-1-ol 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 at https://
www.epa.gov/pesticides/cumulative/.

VIII. Safety Factor for Infants and Children

    FFDCA section 408 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 data base unless EPA concludes that a different 
margin of safety will be safe for infants and children. 3-Hexen-1-ol, 
(3Z)- which is also known as cis -3-hexen-1-ol or leaf alcohol (CAS 
Reg. No. 928-96-1) is naturally-occurring in both the human diet and in 
the atmosphere. The SAR assessment did not indicate any concerns for 
developmental or reproductive toxicity. Exposure resulting from the use 
of 3-hexen-1-ol, (3Z)- at less than 0.4% in the formulated product is 
anticipated to be much smaller than the naturally occurring background 
level of exposure. Given the available information on toxicity and 
exposure, EPA has not used a safety factor analysis to assess the risk 
of 3-hexen-1-ol, (3Z)-. For the same reasons the additional tenfold 
safety factor is unnecessary.

IX. Determination of Safety for U.S. Population and Infants and 
Children

    Based on the available information on toxicity and exposure 
(including the limitation on the amount of 3-hexen-1-ol, (3Z)- that can 
be used in a pesticide formulation), EPA concludes that there is a 
reasonable certainty of no harm from aggregate exposure to residues of 
3-hexen-1-ol, (3Z)- (CAS Reg. No. 928-96-1). EPA finds that 
establishing an exemption from the requirement of a tolerance for 3-
hexen-1-ol, (3Z)- (CAS Reg. No. 928-96-1) will be safe for the general 
population including infants and children.

X. 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

[[Page 31363]]

program, further testing of products containing 3-hexen-1-ol, (3Z)- 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 Exemptions

    There are no existing tolerances or tolerance exemptions for 3-
hexen-1-ol, (3Z)-.

D. International Tolerances

    The Agency is not aware of any country requiring a tolerance for 3-
hexen-1-ol, (3Z)- nor have any CODEX Maximum Residue Levels (MRLs) been 
established for any food crops at this time.

E. Public Comment

    One comment was received from a private citizen requesting that all 
pesticides be banned. The Agency understands the commentor's concerns 
and recognizes that some individuals believe that pesticides should be 
banned completely. However, under the existing legal framework provided 
by section 408 of the FFDCA EPA is authorized to establish pesticide 
tolerances or exemptions where persons seeking such exemptions have 
demonstrated that the pesticide meets the safety standard imposed by 
that statute. The commentor has not provided the Agency with a specific 
rationale or additional information pertaining to the legal standards 
in FFDCA section 408 for opposing the establishment of a tolerance 
exemption for 3-hexen-1-ol, (3Z)-. In the absence of any additional 
information of a factual nature, the Agency can not effectively respond 
to the commentor's disagreement with the Agency's decision.

XI. Conclusions

    Accordingly, an exemption from the requirement for a tolerance is 
established for 3-hexen-1-ol, (3Z)- (CAS Reg. No. 928-96-1) with the 
limitation that not more than 0.4% may be used in the pesticide 
formulation.

XII. 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, EPA will continue to use those procedures, with 
appropriate adjustments, until the necessary modifications can be made. 
The new section 408(g) of the FFDCA 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) 
of the FFDCA, as was provided in the old FFDCA sections 408 and 409 of 
the FFDCA. 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 number OPP-2005-0028 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 August 1, 
2005.
    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 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 (1900L), 
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 Suite 350, 1099 14th St., NW., 
Washington, DC 20005. 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 (202) 564-6255.
    2. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit XI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in ADDRESSES. Mail your 
copies, identified by docket ID number OPP-2005-0028, 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 ADDRESSES. You may also send an electronic copy of 
your request via e-mail to: opp-docket@epa.gov. 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).

XIII. Statutory and Executive Order Reviews

    This final rule establishes an exemption from the tolerance 
requirement 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 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

[[Page 31364]]

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 section 408(d) of the FFDCA, 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, 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 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 section 408(n)(4) of the FFDCA. 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 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.

XIV. 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 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: May 20, 2005.

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. In Sec.  180.910, the table is amended by adding alphabetically the 
following inert ingredient to read as follows:


Sec.  180.910  Exemptions from the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
                              * * * * * * *
3-hexen-1-ol, (3Z)- (CAS Reg.     not more than 0.4%  odorant, alerting
 No. 928-96-1).                    of the pesticide    agent
                                   formulation.
                              * * * * * * *
------------------------------------------------------------------------


[[Page 31365]]

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[FR Doc. 05-10846 Filed 5-31-05; 8:45 am]
BILLING CODE 6560-50-S