Alkyl (C10, 54281-54286 [05-18241]
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Federal Register / Vol. 70, No. 177 / Wednesday, September 14, 2005 / Rules and Regulations
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[FR Doc. 05–18244 Filed 9–13–05; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[OPP–2003–0362; FRL–7729–7]
Alkyl (C10–C16) Polyglycosides;
Exemptions from the Requirement of a
Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes
two exemptions from the requirement of
a tolerance for residues of alkyl (C10–
C16) polyglycosides also known as Dglucopyranose, oligomeric, C10–C16alkyl 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, C10–C16-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 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
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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:
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 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.
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54281
The petition requested that 40 CFR
part 180 be amended by establishing an
exemption from the requirement of a
tolerance for residues of alkyl (C10–C16)
polyglycosides or polyglucosides, also
known as D-glucopyranose, oligomeric,
C10–C16-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,
C10–C16-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
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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 (C8–C10)
polyglycosides, and alkyl (C12–C14)
polyglycosides. The actual substance
used for each test is noted below.
An alkyl polyglycoside is created by
combining glucose and an alcohol.
Alkyl (C8–C10) polyglycosides and alkyl
(C12–C14) polyglycosides are
structurally-related to the alkyl (C10–C16)
polyglycosides also known as Dglucopyranose, oligomeric, C10–C16alkyl 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 publiclyavailable 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
Salmonella/Escherichia reverse gene mutation assay (Ames
Test)*
Results
C12–C14
Negative. No evidence of induced
mutant colonies over background.
Salmonella typhimurium reverse (Ames Test)
Not specified
Did not induce reverse mutations in
the tested strains of Salmonella
typhimurium either with or without
metabolic activation.
In vitro cytogenetic test in Chinese hamster V79 lung fibroblast
Not specified
Considered to be non-mutagenic.
C12–C14
Negative with and without activation.
In vitro mammalian cytogenetics assay*
B. Repeated Dose Toxicity*
In a 90–day rat oral (gavage) toxicity
study, alkyl (C12–C14) polyglucosides
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was administered at dose levels of 0,
250, 500, or 1,000 mg/kg/day for 5 days/
week. An additional high-dose group
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was treated and then had a treatmentfree period of 27 days before sacrifice.
There were no treatment-related
adverse effects on body weight, body
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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 (C12–C14) 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 (C12–C14) 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 bD-glucoside, dodecyl b-D-maltoside, and
hexadecyl b-D-glucoside). The
radiolabeled test material consisted of
octyl b-D-[U-14C]glucoside, [l14C]dodecyl b-D-maltoside and [l14C]hexadecyl b-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.
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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, C10–C16-alkyl glycosides is
likely to be of low acute oral and dermal
toxicity. However, based on the
surrogate data, D-glucopyranose,
oligomeric, C10–C16-alkyl glycosides is
likely to be an eye and dermal irritant
when used at higher concentrations.
Metabolism studies on structurallyrelated chemicals indicate that the body
can effectively metabolize Dglucopyranose, oligomeric, C10–C16alkyl 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 (C12–C14)
polyglucosides, the NOAEL (no
observed adverse effect level) for alkyl
(C12–C14) polyglucosides is 250 mg/kg/
day. In a rat developmental toxicity
study using alkyl (C12–C14)
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, C10–
C16-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 nonoccupational 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
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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, C10–C16-alkyl glycosides.
2. Drinking water exposure. EPA has
estimated the fate and biodegradation
properties of D-glucopyranose,
oligomeric, C10–C16-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 https://
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, C10–C16-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, nonvolatile, 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, C10–C16alkyl 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 Dglucopyranose, oligomeric, C10–C16-
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alkyl glycosides in sources of drinking
water is very unlikely.
VIII. Determination of Safety for U.S.
Population, and Infants and Children
B. Other Non-Occupational Exposure
Based on the available toxicity data,
EPA judges that D-glucopyranose,
oligomeric, C10–C16-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 Dglucopyranose, oligomeric, C10–C16alkyl glycosides (CAS Reg. No. 110615–
47–9). EPA finds that establishing an
exemption from the requirement of a
tolerance for D-glucopyranose,
oligomeric, C10–C16-alkyl glycosides
(CAS Reg. No. 110615–47–9) will be
safe for the general population
including infants and children.
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 Dglucopyranose, oligomeric, C10–C16alkyl glycosides. D-glucopyranose,
oligomeric, C10–C16-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 Dglucopyranose, oligomeric, C10–C16alkyl 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 https://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, C10–C16alkyl 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 Dglucopyranose, oligomeric, C10–C16alkyl glycosides. For the same reasons,
the additional tenfold safety factor for
the protection of infants and children is
unnecessary.
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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,
C10–C16-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 Dglucopyranose, oligomeric, C10–C16alkyl glycosides
D. International Tolerances
The Agency is not aware of any
country requiring a tolerance for Dglucopyranose, oligomeric, C10–C16alkyl 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, C10–C16-alkyl glycosides
(CAS Reg. No. 110615-47-9).
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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
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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 email 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
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
VerDate Aug<18>2005
15:56 Sep 13, 2005
Jkt 205001
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
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Fmt 4700
Sfmt 4700
54285
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.
E:\FR\FM\14SER1.SGM
14SER1
54286
Federal Register / Vol. 70, No. 177 / Wednesday, September 14, 2005 / Rules and Regulations
Dated: September 2, 2005.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.910 the table is amended
by adding alphabetically the following
inert ingredient to read as follows:
I
§ 180.910 Inert ingredients used pre- and
post-harvest; exemption from the
requirement of a tolerance.
* * *
Inert ingredients
*
*
*
D-glucopyranose,
oligomeric, C10–16alkyl glycosides
(CAS Reg. No.
110615–47–9)
*
*
*
Limits
*
Uses
*
*
*
.............. Surfactant
*
*
*
*
*
*
*
*
*
3. In § 180.930 the table is amended
by adding alphabetically the following
inert ingredient to read as follows:
I
§ 180.930 Inert ingredients applied to
animals; exemption from the requirement of
a tolerance.
* * *
Inert ingredients
*
*
*
D-glucopyranose,
oligomeric, C10–16alkyl glycosides
(CAS Reg. No.
110615–47–9)
*
*
*
*
*
*
*
Limits
*
Uses
*
*
*
.............. Surfactant
*
*
*
*
*
[FR Doc. 05–18241 Filed 9–13–05; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 300
[FRL–7968–3]
National Priorities List for Uncontrolled
Hazardous Waste Sites
Environmental Protection
Agency.
ACTION: Final rule.
AGENCY:
SUMMARY: The Comprehensive
Environmental Response,
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15:56 Sep 13, 2005
Jkt 205001
Compensation, and Liability Act of 1980
(‘‘CERCLA’’ or ‘‘the Act’’), as amended,
requires that the National Oil and
Hazardous Substances Pollution
Contingency Plan (‘‘NCP’’) include a list
of national priorities among the known
releases or threatened releases of
hazardous substances, pollutants, or
contaminants throughout the United
States. The National Priorities List
(‘‘NPL’’) constitutes this list. The NPL is
intended primarily to guide the
Environmental Protection Agency
(‘‘EPA’’ or ‘‘the Agency’’) in determining
which sites warrant further
investigation. These further
investigations will allow EPA to assess
the nature and extent of public health
and environmental risks associated with
the site and to determine what CERCLAfinanced remedial action(s), if any, may
be appropriate. This rule adds seven
new sites to the General Superfund
Section of the NPL.
DATES: The effective date for this
amendment to the NCP shall be October
14, 2005.
ADDRESSES: For addresses for the
Headquarters and Regional dockets, as
well as further details on what these
dockets contain, see section II,
‘‘Availability of Information to the
Public’’ in the ‘‘Supplementary
Information’’ portion of this preamble.
FOR FURTHER INFORMATION CONTACT:
Terry Jeng, phone (703) 603–8852, State,
Tribal and Site Identification Branch;
Assessment and Remediation Division;
Office of Superfund Remediation and
Technology Innovation (mail code
5204G); U.S. Environmental Protection
Agency; 1200 Pennsylvania Avenue
NW.; Washington, DC 20460; or the
Superfund Hotline, phone (800) 424–
9346 or (703) 412–9810 in the
Washington, DC, metropolitan area.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background
A. What are CERCLA and SARA?
B. What is the NCP?
C. What is the National Priorities List
(NPL)?
D. How are Sites Listed on the NPL?
E. What Happens to Sites on the NPL?
F. Does the NPL Define the Boundaries of
Sites?
G. How are Sites Removed from the NPL?
H. May EPA Delete Portions of Sites From
the NPL as They Are Cleaned Up?
I. What is the Construction Completion List
(CCL)?
II. Availability of Information to the Public
A. May I Review the Documents Relevant
to this Final Rule?
B. What Documents are Available for
Review at the Headquarters Docket?
C. What Documents are Available for
Review at the Regional Dockets?
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Fmt 4700
Sfmt 4700
D. How Do I Access the Documents?
E. How May I Obtain a Current List of NPL
Sites?
III. Contents of This Final Rule
A. Additions to the NPL
B. Site Name Change
C. What did EPA Do with the Public
Comments It Received?
IV. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory
Planning and Review
1. What is Executive Order 12866?
2. Is this Final Rule Subject to Executive
Order 12866 Review?
B. Paperwork Reduction Act
1. What is the Paperwork Reduction Act?
2. Does the Paperwork Reduction Act
Apply to This Final Rule?
C. Regulatory Flexibility Act
1. What is the Regulatory Flexibility Act?
2. How Has EPA Complied with the
Regulatory Flexibility Act?
D. Unfunded Mandates Reform Act
1. What is the Unfunded Mandates Reform
Act (UMRA)?
2. Does UMRA Apply to This Final Rule?
E. Executive Order 13132: Federalism
1. What Is Executive Order 13132 and Is It
Applicable to This Final Rule?
F. Executive Order 13175: Consultation
and Coordination with Indian Tribal
Governments
1. What is Executive Order 13175?
2. Does Executive Order 13175 Apply to
This Final Rule?
G. Executive Order 13045: Protection of
Children from Environmental Health and
Safety Risks
1. What is Executive Order 13045?
2. Does Executive Order 13045 Apply to
This Final Rule?
H. Executive Order 13211
1. What is Executive Order 13211?
2. Is this Rule Subject to Executive Order
13211?
I. National Technology Transfer and
Advancement Act
1. What is the National Technology
Transfer and Advancement Act?
2. Does the National Technology Transfer
and Advancement Act Apply to this
Final Rule?
J. Possible Changes to the Effective Date of
the Rule
1. Has EPA Submitted This Rule to
Congress and the General Accounting
Office?
2. Could the Effective Date of This Final
Rule Change?
3. What Could Cause a Change in the
Effective Date of This Rule?
I. Background
A. What Are CERCLA and SARA?
In 1980, Congress enacted the
Comprehensive Environmental
Response, Compensation, and Liability
Act, 42 U.S.C. 9601–9675 (‘‘CERCLA’’ or
‘‘the Act’’), in response to the dangers of
uncontrolled releases or threatened
releases of hazardous substances, and
releases or substantial threats of releases
into the environment of any pollutant or
contaminant which may present an
E:\FR\FM\14SER1.SGM
14SER1
]]>Agencies
[Federal Register Volume 70, Number 177 (Wednesday, September 14, 2005)]
[Rules and Regulations]
[Pages 54281-54286]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-18241]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2003-0362; FRL-7729-7]
Alkyl (C10-C16) 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 (C10-
C16) polyglycosides also known as D-glucopyranose,
oligomeric, C10-C16-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,
C10-C16-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 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: (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 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 (C10-C16) polyglycosides or
polyglucosides, also known as D-glucopyranose, oligomeric,
C10-C16-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, C10-C16-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 (C8-C10)
polyglycosides, and alkyl (C12-C14)
polyglycosides. The actual substance used for each test is noted below.
An alkyl polyglycoside is created by combining glucose and an
alcohol. Alkyl (C8-C10) polyglycosides and alkyl
(C12-C14) polyglycosides are structurally-related
to the alkyl (C10-C16) polyglycosides also known
as D-glucopyranose, oligomeric, C10-C16-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
(C12-C14) 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 (C12-
C14) 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 (C12-
C14) 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-14C]glucoside, [l-
14C]dodecyl [beta]-D-maltoside and [l-
14C]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,
C10-C16-alkyl glycosides is likely to be of low
acute oral and dermal toxicity. However, based on the surrogate data,
D-glucopyranose, oligomeric, C10-C16-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,
C10-C16-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
(C12-C14) polyglucosides, the NOAEL (no observed
adverse effect level) for alkyl (C12-C14)
polyglucosides is 250 mg/kg/day. In a rat developmental toxicity study
using alkyl (C12-C14) 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,
C10-C16-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, C10-C16-alkyl glycosides.
2. Drinking water exposure. EPA has estimated the fate and
biodegradation properties of D-glucopyranose, oligomeric,
C10-C16-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 https://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, C10-
C16-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, C10-
C16-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, C10-
C16-
[[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,
C10-C16-alkyl glycosides. D-glucopyranose,
oligomeric, C10-C16-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, C10-C16-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 https://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, C10-C16-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, C10-C16-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, C10-C16-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, C10-
C16-alkyl glycosides (CAS Reg. No. 110615-47-9). EPA finds
that establishing an exemption from the requirement of a tolerance for
D-glucopyranose, oligomeric, C10-C16-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, C10-C16-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, C10-C16-alkyl
glycosides
D. International Tolerances
The Agency is not aware of any country requiring a tolerance for D-
glucopyranose, oligomeric, C10-C16-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, C10-
C16-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: 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 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
