[Federal Register Volume 70, Number 177 (Wednesday, September 14, 2005)]
[Rules and Regulations]
[Pages 54281-54286]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-18241]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0362; FRL-7729-7]


Alkyl (C<INF>10</INF>-C<INF>16</INF>) Polyglycosides; Exemptions 
from the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes two exemptions from the 
requirement of a tolerance for residues of alkyl (C<INF>10</INF>-
C<INF>16</INF>) polyglycosides also known as D-glucopyranose, 
oligomeric, C<INF>10</INF>-C<INF>16</INF>-alkyl glycosides when used as 
an inert ingredient in or on growing crops, when applied to raw 
agricultural commodities after harvest, or to animals. Cognis 
Corporation 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 D-glucopyranose, oligomeric, 
C<INF>10</INF>-C<INF>16</INF>-alkyl glycosides.

DATES: This regulation is effective September 14, 2005. Objections and 
requests for hearings must be received on or before November 14, 2005.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit XI. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under Docket 
identification (ID) number OPP-2003-0362. All documents in the docket 
are listed in the EDOCKET index at http://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 <greek-i>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: (703) 305-6304; e-mail address: <a href="/cdn-cgi/l/email-protection#aeccc1d7c2cb80c5cfdac6dcd7c0eecbdecf80c9c1d8"><span class="__cf_email__" data-cfemail="74161b0d18115a1f15001c060d1a341104155a131b02">[email protected]</span></a>.

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:
    <bullet> Crop production (NAICS code 111)
    <bullet> Animal production (NAICS code 112)
    <bullet> Food manufacturing (NAICS code 311)
    <bullet> 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 (http://www.epa.gov/edocket/), you 
may access this Federal Register document electronically through the 
EPA Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 
CFR part 180 is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.

II. Background and Statutory Findings

    In the Federal Register of December 10, 2003 (68 FR 68908) (FRL-
7335-5), 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 4E4332) by Cognis Corporation, 
490 Este Avenue, Cincinnati, OH 45232. That notice included a summary 
of the petition prepared by the petitioner.
    The petition requested that 40 CFR part 180 be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of alkyl (C<INF>10</INF>-C<INF>16</INF>) polyglycosides or 
polyglucosides, also known as D-glucopyranose, oligomeric, 
C<INF>10</INF>-C<INF>16</INF>-alkyl glycosides (CAS Reg. No. 110615-47-
9) when used as an inert ingredient in pesticide products. There were 
no comments received in response to the notice of filing.
    The Agency has determined that the use of D-glucopyranose, 
oligomeric, C<INF>10</INF>-C<INF>16</INF>-alkyl glycosides (CAS Reg. 
No. 110615-47-9) in a pesticide product is as a surfactant.
    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

[[Page 54282]]

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. Toxicological Profile

    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 information submitted by the 
petitioner for review and evaluation included information on toxicity 
studies performed on alkyl (C<INF>8</INF>-C<INF>10</INF>) 
polyglycosides, and alkyl (C<INF>12</INF>-C<INF>14</INF>) 
polyglycosides. The actual substance used for each test is noted below.
    An alkyl polyglycoside is created by combining glucose and an 
alcohol. Alkyl (C<INF>8</INF>-C<INF>10</INF>) polyglycosides and alkyl 
(C<INF>12</INF>-C<INF>14</INF>) polyglycosides are structurally-related 
to the alkyl (C<INF>10</INF>-C<INF>16</INF>) polyglycosides also known 
as D-glucopyranose, oligomeric, C<INF>10</INF>-C<INF>16</INF>-alkyl 
glycosides that is the subject of this final rule. These chemicals 
differ from one another only in the length of the alkyl chain. Given 
these structural similarities, these chemicals have similar 
toxicological characteristics.
    Two types of data were submitted by the petitioner: Publicly-
available information from open literature and complete toxicity 
studies. The results of the existing reviews in the publicly-available 
information were extracted from the submitted article. The complete 
toxicity studies included two mutagenicity studies, a subchronic 90 day 
study, and a developmental study. These studies were reviewed by the 
Department of Energy's Oakridge National Laboratory (ORNL), and the 
results of their review are presented below, noted by an asterisk (*).

A. Acute Toxicity

                                        Table 1.--Acute Toxicity Studies
----------------------------------------------------------------------------------------------------------------
              Study/Species                         Test Substance                          Results
----------------------------------------------------------------------------------------------------------------
Acute oral toxicity/rat                                               C8-C14          Lethal Dose (LD)50 > 5,000
                                                                                     milligrams/kilogram (mg/kg)
------------------------------------------------------------------------------
Acute oral toxicity/rat                                              C12-C14                  LD50 > 5,000 mg/kg
------------------------------------------------------------------------------
Acute oral toxicity/rat                                              C12-C14                  LD50 > 2,000 mg/kg
------------------------------------------------------------------------------
Acute dermal toxicity/rabbit                                          C8-C10                  LD50 > 2,000 mg/kg
------------------------------------------------------------------------------
Acute dermal toxicity/rabbit                                         C12-C14                  LD50 > 2,000 mg/kg
------------------------------------------------------------------------------
Primary eye irritation/rabbit                                         C8-C10               No irritating effects
------------------------------------------------------------------------------
Primary eye irritation/rabbit                                        C12-C14               Irritating to the eye
------------------------------------------------------------------------------
Primary dermal irritation/rabbit                                      C8-C10               No irritating effects
------------------------------------------------------------------------------
Primary dermal irritation/rabbit                                     C12-C14            No irritating effects at
                                                                                     concentrations of up to 30%
                                                                                       Irritating to the skin at
                                                                              concentrations greater than 30% to
                                                                                                           100%.
------------------------------------------------------------------------------
Dermal sensitization/guinea pig                                       C8-C10             Not a dermal sensitizer
------------------------------------------------------------------------------
Dermal sensitization/guinea pig                                      C12-C14             Not a dermal sensitizer
----------------------------------------------------------------------------------------------------------------


                                         Table 2.--Mutagenicity Studies
----------------------------------------------------------------------------------------------------------------
              Type of Study                         Test Substance                          Results
----------------------------------------------------------------------------------------------------------------
Salmonella/Escherichia reverse gene                                  C12-C14    Negative. No evidence of induced
 mutation assay (Ames Test)*                                                    mutant colonies over background.
------------------------------------------------------------------------------
Salmonella typhimurium reverse (Ames                           Not specified    Did not induce reverse mutations
 Test)                                                                                  in the tested strains of
                                                                              Salmonella typhimurium either with
                                                                                or without metabolic activation.
------------------------------------------------------------------------------
In vitro cytogenetic test in Chinese                           Not specified     Considered to be non-mutagenic.
 hamster V79 lung fibroblast
------------------------------------------------------------------------------
In vitro mammalian cytogenetics assay*                               C12-C14           Negative with and without
                                                                                                     activation.
----------------------------------------------------------------------------------------------------------------

B. Repeated Dose Toxicity*

    In a 90-day rat oral (gavage) toxicity study, alkyl 
(C<INF>12</INF>-C<INF>14</INF>) polyglucosides was administered at dose 
levels of 0, 250, 500, or 1,000 mg/kg/day for 5 days/week. An 
additional high-dose group was treated and then had a treatment-free 
period of 27 days before sacrifice.
    There were no treatment-related adverse effects on body weight, 
body

[[Page 54283]]

weight gain, food consumption, hematological or clinical chemistry 
parameters or organ weights in any group. Adverse treatment-related 
effects were limited to the forestomach in both males and females 
receiving 500 or 1,000 mg/kg/day. After 27 days, it was observed that 
forestomach effects were reversible following the cessation of 
treatment, but not during treatment. Under the conditions of the study, 
the NOAEL (no observed adverse effect level) for alkyl (C<INF>12</INF>-
C<INF>14</INF>) polyglucosides is 250 mg/kg/day. The LOAEL (lowest 
observed adverse effect level) is 500 mg/kg/day based on acanthosis, 
subepithelial inflammatory edema, and hyperkeratosis (females only) of 
the forestomach, which did not resolve during the treatment period.

C. Developmental Toxicity*

    In a rat developmental toxicity study, alkyl (C<INF>12</INF>-
C<INF>14</INF>) polyglucosides was administered by gavage at dose 
levels of 0, 100, 300, and 1,000 mg/kg/day on gestation days 6 to 15. 
No treatment related maternal deaths, clinical signs, or decreases in 
mean body weight, weight gain, corrected weight gain or gross lesions 
were observed in this study. The maternal NOAEL is equal to or greater 
than 1,000 mg/kg/day. A LOAEL was not determined, but would be greater 
than 1,000 mg/kg/day.
    No treatment-related effects were observed on any cesarean section 
parameter. No treatment-related external abnormalities, visceral 
abnormalities or skeletal malformations/variations, including the 
number of ossification sites were observed at any dose. The 
developmental NOAEL is equal to or greater than 1,000 mg/kg/day. A 
LOAEL was not determined, but would be greater than 1,000 mg/kg/day.

D. Metabolism

    The petitioner submitted an article from open literature on 
metabolism studies in mice conducted with the structurally-related 
chemicals (octyl [beta]-D-glucoside, dodecyl [beta]-D-maltoside, and 
hexadecyl [beta]-D-glucoside). The radiolabeled test material consisted 
of octyl [beta]-D-[U-<SUP>14</SUP>C]glucoside, [l-
<SUP>14</SUP>C]dodecyl [beta]-D-maltoside and [l-
<SUP>14</SUP>C]hexadecyl [beta]-D-glucoside). The treated animals were 
sacrificed two hours following administration of the test material. 
Radioactivity analysis indicated that most radioactivity was found in 
the stomach, intestine, liver and kidneys. The test material was 
hydrolyzed to form sugar and long chain alcohols, which were then 
processed in the mammalian body's pathways for carbohydrate and lipid 
metabolism. Most metabolites were excreted via urine, and appeared to 
be water soluble.

E. Conclusions

    Acute toxicity studies on various chain lengths of alkyl 
polyglucosides indicate that D-glucopyranose, oligomeric, 
C<INF>10</INF>-C<INF>16</INF>-alkyl glycosides is likely to be of low 
acute oral and dermal toxicity. However, based on the surrogate data, 
D-glucopyranose, oligomeric, C<INF>10</INF>-C<INF>16</INF>-alkyl 
glycosides is likely to be an eye and dermal irritant when used at 
higher concentrations.
    Metabolism studies on structurally-related chemicals indicate that 
the body can effectively metabolize D-glucopyranose, oligomeric, 
C<INF>10</INF>-C<INF>16</INF>-alkyl glycosides to water-soluble 
substances (predominantly sugar and various alcohols) that are readily 
excreted from the body.
    In a 90-day rat oral (gavage) toxicity study, using alkyl 
(C<SUP>12</SUP>-C<SUP>14</SUP>) polyglucosides, the NOAEL (no observed 
adverse effect level) for alkyl (C<SUP>12</SUP>-C<SUP>14</SUP>) 
polyglucosides is 250 mg/kg/day. In a rat developmental toxicity study 
using alkyl (C<SUP>12</SUP>-C<SUP>14</SUP>) polyglucosides, both the 
maternal and developmental NOAELs are equal to or greater than 1000 mg/
kg/day.
    Mutagenicity studies on various chain lengths of alkyl 
polyglucosides indicate that D-glucopyranose, oligomeric, 
C<INF>10</INF>-C<INF>16</INF>-alkyl glycosides is not likely to be 
mutagenic based on the two mutagenicity assays reviewed by the Agency 
and the two mutagenicity assays described in open literature.

V. 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 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. The Agency has developed a screening-level model for 
predicting dietary exposure to inert ingredients. The results of this 
model are considered to over-estimate exposure to an inert ingredient 
in a pesticide product. The modeled chronic dietary exposure for the US 
population is 0.12 mg/kg/day. This is well-below any dose level at 
which an adverse effect is expected from exposure to D-glucopyranose, 
oligomeric, C<INF>10</INF>-C<INF>16</INF>-alkyl glycosides.
    2. Drinking water exposure. EPA has estimated the fate and 
biodegradation properties of D-glucopyranose, oligomeric, 
C<INF>10</INF>-C<INF>16</INF>-alkyl glycosides using EPI-Suite. 
Screening-level tools such as EPI-Suite are deliberately designed to be 
easy-to-use, fast, and conservative in nature. (see http://www.epa.gov/opptintr/exposure/docs/episuite.htm). If modeled estimates do not 
indicate a level of concern, then higher-tiered modeling or measured 
data may not be needed. The modeled estimates indicate that a chemical 
substance such as D-glucopyranose, oligomeric, C<INF>10</INF>-
C<INF>16</INF>-alkyl glycosides is expected to degrade rapidly in the 
environment. Degradation begins within a matter of hours or days, with 
these primary degradation products including glucose and various 
alcohols which will continue to degrade. Ultimate degradation (to 
carbon dioxide and water) occurs in days to weeks. These glycoside 
compounds are soluble, non-volatile, and mobile. Leaching to ground 
water is likely in highly porous soils, but mitigated in other soils 
due to the rapid biodegradation. Volatilization from surface waters is 
very low. Migration to ground water drinking water sources is possible, 
but will be limited by the rapid primary degradation.
    Based on values estimated using the EPI-Suite model, it is very 
unlikely that D-glucopyranose, oligomeric, C<INF>10</INF>-
C<INF>16</INF>-alkyl glycosides will reach either ground or surface 
water, or bioaccumulate in the environment. This conclusion is based on 
its rather rapid primary degradation (estimated to be hours to days), 
and ultimate biodegradation to carbon dioxide and water. Significant 
concentrations of D-glucopyranose, oligomeric, C<INF>10</INF>-
C<INF>16</INF>-

[[Page 54284]]

alkyl glycosides in sources of drinking water is very unlikely.

B. Other Non-Occupational Exposure

    Various alkyl polyglucosides are used in glass cleaners and other 
household cleaning products, as rinse aids in dish washers, and in 
cleaning products used by the food industry.

VI. Cumulative Effects

    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 for D-glucopyranose, oligomeric, 
C<INF>10</INF>-C<INF>16</INF>-alkyl glycosides. D-glucopyranose, 
oligomeric, C<INF>10</INF>-C<INF>16</INF>-alkyl glycosides does not 
appear to produce any toxic metabolite produced by other substances and 
the overall toxicity of this compound is very low. For the purposes of 
this tolerance action, therefore, EPA has not assumed that D-
glucopyranose, oligomeric, C<INF>10</INF>-C<INF>16</INF>-alkyl 
glycosides 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 http://www.epa.gov/pesticides/cumulative/.

VII. 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 database unless EPA concluded that a different 
margin of safety will be safe for infants and children.
    D-glucopyranose, oligomeric, C<INF>10</INF>-C<INF>16</INF>-alkyl 
glycosides is of low acute toxicity, and is readily metabolized in the 
mammalian body. In a developmental toxicity study reviewed and 
evaluated by ORNL for EPA, the developmental NOAEL is equal to or 
greater than 1,000 mg/kg/day. Due to the expected low oral toxicity, a 
safety factor analysis has not been used to assess the risk of D-
glucopyranose, oligomeric, C<INF>10</INF>-C<INF>16</INF>-alkyl 
glycosides. For the same reasons, the additional tenfold safety factor 
for the protection of infants and children is unnecessary.

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

    Based on the available toxicity data, EPA judges that D-
glucopyranose, oligomeric, C<INF>10</INF>-C<INF>16</INF>-alkyl 
glycosides is a chemical of lower toxicity. Therefore, EPA concludes 
that there is a reasonable certainty of no harm from aggregate exposure 
to residues of D-glucopyranose, oligomeric, C<INF>10</INF>-
C<INF>16</INF>-alkyl glycosides (CAS Reg. No. 110615-47-9). EPA finds 
that establishing an exemption from the requirement of a tolerance for 
D-glucopyranose, oligomeric, C<INF>10</INF>-C<INF>16</INF>-alkyl 
glycosides (CAS Reg. No. 110615-47-9) will be safe for the general 
population including infants and children.

IX. 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 D-glucopyranose, 
oligomeric, C<INF>10</INF>-C<INF>16</INF>-alkyl glycosides 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 D-
glucopyranose, oligomeric, C<INF>10</INF>-C<INF>16</INF>-alkyl 
glycosides

D. International Tolerances

    The Agency is not aware of any country requiring a tolerance for D-
glucopyranose, oligomeric, C<INF>10</INF>-C<INF>16</INF>-alkyl 
glycosides nor have any CODEX Maximum Residue Levels (MRLs) been 
established for any food crops at this time.

X. Conclusions

    Accordingly, an exemption from the requirement for a tolerance is 
established for D-glucopyranose, oligomeric, C<INF>10</INF>-
C<INF>16</INF>-alkyl glycosides (CAS Reg. No. 110615-47-9).

XI. 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-2003-0362 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 
14, 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 issue(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

[[Page 54285]]

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-2003-0362, 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: <a href="/cdn-cgi/l/email-protection#81eef1f1ace5eee2eae4f5c1e4f1e0afe6eef7"><span class="__cf_email__" data-cfemail="91fee1e1bcf5fef2faf4e5d1f4e1f0bff6fee7">[email protected]</span></a>. 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 issue(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

XII. 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 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.

XIII. 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.



[[Page 54286]]


    Dated: September 2, 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   Inert ingredients used pre- and post-harvest; exemption 
from the requirement of a tolerance.

    * * *

------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
                              * * * * * * *
D-glucopyranose, oligomeric,      ..................  Surfactant
 C10	16-alkyl glycosides (CAS
 Reg. No. 110615-47-9)
                              * * * * * * *
------------------------------------------------------------------------

* * * * *
0
3. In Sec.  180.930 the table is amended by adding alphabetically the 
following inert ingredient to read as follows:


Sec.  180.930  Inert ingredients applied to animals; exemption from the 
requirement of a tolerance.

    * * *

------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
                              * * * * * * *
D-glucopyranose, oligomeric,      ..................  Surfactant
 C10	16-alkyl glycosides (CAS
 Reg. No. 110615-47-9)
                              * * * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. 05-18241 Filed 9-13-05; 8:45 am]
BILLING CODE 6560-50-S


</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>