Alpha-cyclodextrin, Beta-cyclodextrin, and Gamma-cyclodextrin; Exemption from the Requirement of a Tolerance, 38780-38785 [05-13263]
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38780
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 63
[AD–FRL–7933–2]
RIN 2060–AM72
National Emission Standards for
Hazardous Air Pollutants:
Miscellaneous Coating Manufacturing
Environmental Protection
Agency (EPA).
ACTION: Withdrawal of direct final rule.
AGENCY:
SUMMARY: On May 13, 2005, the EPA
issued direct final amendments to the
national emission standards for
hazardous air pollutants (NESHAP) for
Miscellaneous Coating Manufacturing.
The amendments were issued as a direct
final rule, along with a parallel proposal
to be used as the basis for final action
in the event EPA received any adverse
comments on the direct final
amendments. Because an adverse
comment was received on one
provision, EPA is withdrawing the
corresponding parts of the direct final
rule. We stated in that direct final rule
that if we received adverse comment by
June 13, 2005, we would publish a
timely withdrawal in the Federal
Register. We will address the adverse
comment in a subsequent final action
based on the parallel proposal
published on May 13, 2005 (70 FR
25684). As stated in the parallel
proposal, we will not institute a second
comment period on this action.
DATES: As of July 6, 2005, EPA
withdraws the direct final rule revision
for 40 CFR 63.8055(b)(4), published on
May 13, 2005 (70 FR 25676). The
remaining provisions published on May
13, 2005, will be effective on July 12,
2005.
ADDRESSES: EPA has established a
docket for this action under Docket ID
No. OAR–2003–0178. All documents in
the docket are listed in the 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: Air and Radiation Docket, EPA/
DC, EPA West, Room B102, 1301
Constitution Ave., NW., Washington,
DC. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding legal
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holidays. The telephone number for the
Public Reading Room is (202) 566–1744,
and the telephone number for the Air
Docket is (202) 566–1742.
FOR FURTHER INFORMATION CONTACT: Mr.
Randy McDonald, Organic Chemicals
Group, Emission Standards Division
(Mail Code C504–04), U.S. EPA,
Research Triangle Park, North Carolina
27711, telephone number (919) 541–
5402, electronic mail address
mcdonald.randy@epa.gov.
SUPPLEMENTARY INFORMATION: On May
13, 2005, we published a direct final
rule (70 FR 25676) and a parallel
proposal (70 FR 25684) amending the
NESHAP for Miscellaneous Coating
Manufacturing (40 CFR part 63, subpart
HHHHH). The direct final rule amended
the NESHAP by providing additional
compliance options and clarifications.
Specifically, the direct final rule
amendments specified that compliance
with a percent reduction emission limit
may be demonstrated by measuring total
organic compounds (TOC), compliance
with the weight percent hazardous air
pollutant (HAP) limit in coatings
products may be demonstrated based on
formulation data, and the cover or lid on
a process vessel may be opened for
material additions and sampling. The
direct final rule amendments also
clarified the requirements for cleaning
operations, the compliance date for
equipment that is added to an existing
source, the conditions under which you
must determine whether an emission
stream is a halogenated vent stream, and
the terminology used to describe the
emission limits for process vessels. The
direct final rule amendments also
revised the definition of Group 2
transfer operations to clarify that all
product loading operations are part of
the miscellaneous coating
manufacturing. We stated in the
preamble to the direct final rule and
parallel proposal that if we received
adverse comments by June 13, 2005, (or
if a public hearing was requested by
May 23, 2005) on one or more distinct
provisions of the direct final rule, we
would publish a timely notice in the
Federal Register specifying which
provisions will become effective and
which provisions will be withdrawn
due to adverse comment. We
subsequently received adverse comment
from one commenter on the amendment
to allow compliance with the weight
percent HAP limit in coating products
may be demonstrated based on
formulation data. The commenter’s
claim is that if EPA does not allow the
mass cutoffs of 0.1 percent for OSHAdefined carcinogens or 1 percent for
other HAP used in Material Safety Data
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Sheets (MSDS), then the option is very
limited.
Accordingly, we are withdrawing the
amendment, 40 CFR 63.8055(b)(4). The
amendment is withdrawn as of July 6,
2005. We will take final action on the
proposed rule after considering the
comment received. We also received a
comment regarding chemical processes
involving reactions that produce
materials that may have a coatingapplication end use. However, the
commenter referred to preamble
language merely clarifying existing rule
language in overlapping standards, and
not new language provided by the direct
final rule. We have not changed any of
the rule language discussed in the
clarification of overlapping standards
section of the preamble. Thus, this
comment is not an adverse comment on
the amendments themselves, but rather
an adverse comment on the definition of
coating manufacturing in the original
rule.
We will not institute a second
comment period on this action. The
provisions for which we did not receive
adverse comment will become effective
on July 12, 2005, as provided in the
preamble to the direct final rule.
List of Subjects in 40 CFR Part 63
Environmental protection,
Administrative practice and procedure,
Air pollution control, Hazardous
substances, Intergovernmental relations,
Reporting and recordkeeping
requirements.
Dated: June 29, 2005.
Jeffrey R. Holmstead,
Assistant Administrator, Air and Radiation.
[FR Doc. 05–13275 Filed 7–5–05; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[OPP–2002–0294; FRL–7720–9]
Alpha-cyclodextrin, Beta-cyclodextrin,
and Gamma-cyclodextrin; Exemption
from the Requirement of a Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes an
exemption from the requirement of a
tolerance under 40 CFR 180.950 for
residues of alpha-cyclodextrin, betacyclodextrin, and gamma-cyclodextrin
when used in or on various food
commodities. Wacker Specialties
submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act
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Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
(FFDCA), as amended by the Food
Quality Protection Act (FQPA) of 1996,
requesting an exemption from the
requirement of a tolerance. This
regulation eliminates the need to
establish a maximum permissible level
for residues of alpha-cyclodextrin, betacyclodextrin, and gamma-cyclodextrin.
DATES: This regulation is effective July
6, 2005. Objections and requests for
hearings must be received on or before
September 6, 2005.
ADDRESSES: To submit a written
objection or hearing request follow the
detailed instructions as provided in
Unit VIII. of the SUPPLEMENTARY
INFORMATION. EPA has established a
docket for this action under docket
identification (ID) number OPP–2002–
0294. 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 #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:
Rame Cromwell, Registration Division
(7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 308–9068; e-mail address:
cromwell.rame@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
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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 Access Electronic Copies
of this Document and Other Related
Information?
In addition to using EDOCKET
(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 November
14, 2002 (67 FR 220) (FRL–7279–3),
EPA issued a notice pursuant to section
408(d)(3) of the FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide tolerance petition (2E6514) by
Wacker Specialities, 3301 Sutton Road,
Adrian, MI, 49221–9397. The petition
requested that residues of a certain
pesticide chemical in or on various food
commodities be exempted from the
requirement of a tolerance. This notice
included a summary of the petition
prepared by the petitioner Wacker
Specialties. No comment was submitted.
Section 408(c)(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(c)(2)(A)(ii) defines ‘‘safe’’ to
mean that ‘‘there is a reasonable
certainty that no harm will result from
aggregate exposure to the pesticide
chemical residue, including all
anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Pursuant to
section 408(c)(2)(B), in establishing or
maintaining in effect an exemption from
the requirement of a tolerance, EPA
must take into account the factors set
forth in section 408(b)(2)(C), which
requires EPA to give special
consideration to exposure of infants and
children to the pesticide chemical
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38781
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 establishes exemptions from the
requirement of a tolerance only in those
cases where it can be clearly
demonstrated that the risk 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.
EPA performs a number of analyses to
determine the risks from aggregate
exposure to pesticide residues. First,
EPA determines the toxicity of the
pesticide chemical. Second, EPA
examines exposure to the pesticide
through food, drinking water, and
through other exposures that occur as a
result of pesticide use in residential
settings.
III. Inert ingredient Definition
Inert ingredients are all ingredients
that are not active ingredients as defined
in 40 CFR 153.125 and include, but are
not limited to, the following types of
ingredients (except when they have a
pesticidal efficacy of their own):
Solvents such as alcohols and
hydrocarbons; surfactants such as
polyoxyethylene polymers and fatty
acids; carriers such as clay and
diatomaceous earth; thickeners such as
carrageenan and modified cellulose;
wetting, spreading, and dispersing
agents; propellants in aerosol
dispensers; microencapsulating agents;
and emulsifiers. The term ‘‘inert’’ is not
intended to imply nontoxicity; the
ingredient may or may not be
chemically active. Generally, EPA has
exempted inert ingredients from the
requirement of a tolerance based on the
low toxicity of the individual inert
ingredients.
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Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
IV. Description of Alpha-cyclodextrin,
Beta-cyclodextrin, and Gammacyclodextrin
Alpha-cyclodextrin is a non-reducing
cyclic saccharide comprised of six
glucose units linked by alpha-1,4 bonds.
It is produced by the action of
cyclodextrin glucosyltransferase
(CGTase) on hydrolyzed starch syrups at
neutral pH and moderate temperatures.
Beta- cyclodextrin is a cyclic heptamer
composed of seven glucose units joined
‘‘head-to-tail’’ by alpha-1,4 links.
Gamma-cyclodextrin is a ring-shaped
molecule made up of eight glucose units
linked by alpha-1,4 bonds. Alphacyclodextrin, beta-cyclodextrin, and
gamma-cyclodextrin are naturally
occurring compounds derived from the
degradation of starch by the
glucosyltransferase enzyme (CGTase).
They are formed naturally from bacteria
and synthetically. The annular (or
doughnut-shaped) structure provides a
hydrophobic cavity that allows
formulation of inclusion complexes
with a variety of non-polar organic
molecules of appropriate size. The
hydrophobic nature of the outer surface
of the cyclic structure makes the
compounds water soluble. The
hydrophobic cavity and the hydrophilic
outer surface form the basis for its use
in the food industry.
V. Toxicological Profile
Consistent with section 408(b)(2)(D)
of FFDCA, EPA has reviewed the
available scientific data and other
relevant information in support of this
action and considered its validity,
completeness and reliability and the
relationship of this information to
human risk. EPA has also considered
available information concerning the
variability of the sensitivities of major
identifiable subgroups of consumers,
including infants and children.
The Joint Expert Food Committee
Additives (JEFCA) is an international
expert scientific committee that is
administered jointly by the Food and
Agriculture Organization of the United
Nations (FAO) and the World Health
Organization (WHO). In the Food
Additive Series 32, 42, and 48, JEFCA
reviewed alpha-, beta-, and gammacyclodextrins and assigned an
acceptable daily intake (ADI) of ‘‘not
specified’’ to alpha-cyclodextrin. As to
beta-cyclodextrin, a temporary ADI of
0–6 milligrams/kilogram (mg/kg) was
allocated, based on a no adverse
observed effect level (NAOEL) of 2.5%
in the diet (equal to 1,230 mg/kg/bwt
day) in the study of dogs using a safety
factor of 200. As to gamma-cyclodextrin,
there were sufficient data to allocate a
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temporary ADI of ‘‘not specified.’’ A
‘‘not specified’’ designation is used to
refer to a food substance of very low
toxicity, with, on the basis of the
available data (chemical, biochemical,
and other) and the total dietary intake
of the substance, does not, in the
opinion of the Committee, represent a
hazard to health. These compounds are
natural occurring cyclic non-reducing
torus-shaped maltooligosaccharides.
They originate from the decomposition
of starch by a bacterial enzyme called
cyclodextrin glycosyltransferase. Alpha, beta-, and gamma-cyclodextrins are
comprised of D-glucose molecules.
In its May 20, 2003, response to a
Generally Recognized as Safe (GRAS)
notification, the Food and Drug
Administration (FDA) had no questions
regarding a conclusion by qualified
experts that alpha-, beta-, and gammacyclodextrins meet appropriate food
grade specifications and if
manufactured in accordance with good
manufacturing practices are generally
recognized as safe.
Alpha-cyclodextrin was examined by
JEFCA for its ability to induce ocular
irritation in albino rabbits in two
separate studies. In the first study, a
dose of 0.062 g instilled in the
conjuctival cul-de-sac of the right eye of
three rabbits was irritating but not
corrosive. In the second study, two
groups of three rabbits were given
alpha-cyclodextrin as a 14.5% or a 50%
dilution in demineralized water. No or
minimal irritation was found in the eyes
and there was no corrosion.
A sample of 0.5 of alpha-cyclodextrin
moistened with tap water was applied
to the shaven backs and flanks of three
albino rabbits for 4 hours under a semiocclusive dressing. No skin irritation
was observed for up to 72 hours.
Similarly, in guinea-pigs, a 10% or 30%
solution of alpha-cyclodextrin induced
no signs of sensitization in the dermally
induced animals.
Short-term (28-day and 90-day)
studies of toxicity indicated that alphacyclodextrin has little effect when given
orally to rats and dogs. Alphacyclodextrin is not digested in the
gastrointestinal tract but is fermented by
the intestinal micro flora. Absorbed
alpha-cyclodextrin is excreted rapidly
in the urine.
Studies conducted with mice, rabbits,
and rats with alpha-cyclodextrin at
concentrations of up to 20% did not
indicate teratogenic effects.
Beta-cyclodextrin of 0.5 g moistened
with 0.5 ml saline was applied to
shaved dorsal skin of 3 white rabbits
under occlusion for 24 hours. The mean
primary irritation score was 0.50
(minimally irritating), and there were no
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eschar or oedma and the treatment sites
were normal by 24 hours after removal
of the pad containing the chemical. A
primary dermal irritation study in
albino rabbits used an abraded skin
protocol, and the index of primary
cutaneous irritation which was obtained
(0.01) classified beta- cyclodextrin as
non-irritant.
In an ocular irritancy/corrosion test in
albino rabbits, beta-cyclodextrin was
classified as slightly irritating.
Gamma-cyclodextrin was not
irritating or corrosive to the eyes of
albino rabbits. In a skin sensitization
assay in guinea-pigs, a 30% solution
induced no signs of sensitization.
Short term (28-day and 90-day)
studies of toxicity indicate that gammacyclodextrin has little toxicity when
given orally to rats or dogs. Studies
conducted in rats and rabbits with
gamma-cyclodextrin at doses up to 20%
of the diet did not indicate any
teratogenic effects. Similarly, the results
of a battery of studies of genotoxicity
were negative. Long-term studies of
toxicity, carcinogenicity, and
reproductive toxicity have not been
conducted, but, given the rapid
metabolism of this substance to glucose
and its lack of genotoxicity, such studies
were not required for an evaluation.
VI. Aggregate Exposure
1. Food. Alpha-cyclodextrin, betacyclodextrin, and gamma-cyclodextrin
are naturally occurring and are used as
food additives. The following was taken
from the WHO INCHEM (Food
Additives Series 32, 42, 48). Alphacyclodextrin is used as a carrier for
flavors, colors, and sweeteners in foods
such as dry mixes, baked goods, and
instant teas and coffee, as a stabilizer for
flavors, colors, vitamins, and
polyunsaturated fatty acids in dry mixes
and dietary supplements (< 1% of the
final product), as a flavor modifier in
soya milk (< 1%), and as an absorbent
(breath freshener) in confectionery
products (10–15% of the final product).
Beta-cyclodextrin may serve as a
stabilizer of food flavors, food colors
and some vitamins.
Gamma-cyclodextrin is used as a
carrier for flavors, sweeteners, and
colors, and it has been proposed for use
in this manner in dry mixes for
beverages, soups, dressings, gravies and
fillings. It is also used in instant coffee,
tea, chewing gum, crackers, and spices.
It is also proposed for use as a carrier
for vitamins and polyunsaturated fatty
acids in dry food mixes and in dietary
supplements.
2. Drinking water exposure. Alpha-,
beta-, and gamma-cyclodextrins are
highly soluble in water, non-volatile,
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have a low air: water partition
coefficient, and will not be mobile in
soils and sediments. Cyclodextrins will
rapidly biodegrade with primary
degradation occurring in a matter of
hours and ultimate degradation
occurring in days. No significant
exposure to alpha-, beta-, and gammacyclodextrins via drinking water is
anticipated.
Due to the high molecular weight of
the alpha-, beta-, and gammacyclodextrins, absorption through the
skin is expected to be negligible.
Therefore, no significant systemic
exposure is anticipated for these
chemicals from residential use as inert
ingredients in pesticide products.
VII. Cumulative Effects
Section 408(b)(2)(D)(v) of FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance exemption, the Agency
consider ‘‘available information’’
concerning the cumulative effects of a
particular chemical’s residues and other
substances that have a common
mechanism of toxicity.
Unlike other pesticides chemicals for
which EPA has followed a cumulative
risk approach based on a common
mechanism of toxicity, EPA has not
made a common mechanism of toxicity
finding as to alpha-, beta-, and gammacyclodextrins and any other substances
and they do not appear to produce a
toxic metabolite produced by other
substances. For the purpose of this
tolerance action, therefore, EPA has not
assumed that alpha-, beta-, and gammacyclodextrins have 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
determination and procedures for
cumulating effects from substances
found to have a common mechanism on
EPA’s website at https://www.epa.gov/
pesticides/cumulative/.
VIII. Safety Factor for Infants and
Children
FFDCA section 408 provides that EPA
shall apply an additional tenfold margin
of safety for infants and children in the
case of threshold effects to account for
prenatal and postnatal toxicity and the
completeness of the data base unless
EPA concludes that a different margin of
safety will be safe for infants and
children. The Agency believes that
alpha-, beta-, and gamma- cyclodextrins
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to be of low toxicity. EPA has not used
a safety factor analysis to assess the risk,
and therefore the additional tenfold
safety factor is unnecessary.
IX. Determination of Safety for U.S.
Population, Infants and Children
Based on the available information
demonstrating that alpha-, beta-, and
gamma-cyclodextrins are of low
toxicity, EPA concludes there is a
reasonable certainty no harm will result
to the general population including
infants and children from aggregate
exposure to alpha-, beta-, and gammacyclodextrin residues when used as
inert ingredients in pesticide products.
X. Other Considerations
A. Endocrine Disruptors
FQPA requires EPA to develop a
screening program to determine whether
certain substances, including all
pesticide chemicals (both inert and
active ingredients), ‘‘may have an effect
in humans that is similar to an effect
produced by a naturally occurring
estrogen, or such other endocrine effect.
. . .’’ EPA has been working with
interested stakeholders to develop a
screening and testing program as well as
a priority setting scheme. As the Agency
proceeds with implementation of this
program, further testing of products
containing alpha-, beta- and gammacyclodextrins for endocrine effects may
be required.
B. Analytical Method(s)
An analytical method is not required
for enforcement purposes because the
Agency is establishing an exemption
from the requirement of a tolerance
without any numerical limitation.
C. Existing Tolerances
There are no existing tolerances or
tolerance exemptions for alpha, beta,
and gamma-cyclodextrins.
D. International Tolerances
The Agency is not aware of any
country requiring a tolerance for alpha,
beta, or gamma-cyclodextrins nor have
any CODEX Maximum Residue Levels
been established for any food crops at
this time.
E. Response to Comment
No comments were received regarding
the Notice of filling (67 FR 220) (FRL–
7279–3).
XI. Conclusions
Based on the available information on
alpha-, beta-, and gamma-cyclodextrin,
there is a low likelihood of concern for
substantial exposures to non-target
organisms from the use of these
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chemicals as inert ingredients in
pesticide products. EPA concludes that
there is a reasonable certainty of no
harm from aggregate exposure from
residues of alpha-, beta-, and gammacyclodextrin. Accordingly, EPA finds
that exempting alpha-, beta-, and
gamma- cyclodextrins from the
requirement of tolerance will be safe to
the general population and infants and
children.
XII. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as
amended by the FQPA, any person may
file an objection to any aspect of this
regulation and may also request a
hearing on those objections. The EPA
procedural regulations which govern the
submission of objections and requests
for hearings appear in 40 CFR part 178.
Although the procedures in those
regulations require some modification to
reflect the amendments made to the
FFDCA by the FQPA of 1996, EPA will
continue to use those procedures, with
appropriate adjustments, until the
necessary modifications can be made.
The new section 408(g) provides
essentially the same process for persons
to ‘‘object’’ to a regulation for an
exemption from the requirement of a
tolerance issued by EPA under new
section 408(d), as was provided in the
old FFDCA sections 408 and 409.
However, the period for filing objections
is now 60 days, rather than 30 days.
A. What Do I Need to Do to File an
Objection or Request a Hearing?
You must file your objection or
request a hearing on this regulation in
accordance with the instructions
provided in this unit and in 40 CFR part
178. To ensure proper receipt by EPA,
you must identify docket ID number
OPP –2002–0294. 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 September 6, 2005.
1. Filing the request. Your objection
must specify the specific provisions in
the regulation that you object to, and the
grounds for the objections (40 CFR
178.25). If a hearing is requested, the
objections must include a statement of
the factual issues(s) on which a hearing
is requested, the requestor’s contentions
on such issues, and a summary of any
evidence relied upon by the objector (40
CFR 178.27). Information submitted in
connection with an objection or hearing
request may be claimed confidential by
marking any part or all of that
information as CBI. Information so
marked will not be disclosed except in
accordance with procedures set forth in
40 CFR part 2. A copy of the
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information that does not contain CBI
must be submitted for inclusion in the
public record. Information not marked
confidential may be disclosed publicly
by EPA without prior notice.
Mail your written request to: Office of
the Hearing Clerk (1900L),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001. You may also deliver
your request to the Office of the Hearing
Clerk in Suite 350, 1099 14th St., NW.,
Washington, DC 20005. The Office of
the Hearing Clerk is open from 8 a.m.
to 4 p.m., Monday through Friday,
excluding legal holidays. The telephone
number for the Office of the Hearing
Clerk is (202) 564–6255.
2. Copies for the Docket. In addition
to filing an objection or hearing request
with the Hearing Clerk as described in
Unit VIII.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–2002 –0294, 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. 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: oppdocket@epa.gov. Please use an ASCII
file format and avoid the use of special
characters and any form of encryption.
Copies of electronic objections and
hearing requests will also be accepted
on disks in WordPerfect 6.1/8.0 or
ASCII file format. Do not include any
CBI in your electronic copy. You may
also submit an electronic copy of your
request at many Federal Depository
Libraries.
B. When Will the Agency Grant a
Request for a Hearing?
A request for a hearing will be granted
if the Administrator determines that the
material submitted shows the following:
There is a genuine and substantial issue
of fact; there is a reasonable possibility
that available evidence identified by the
requestor would, if established resolve
one or more of such issues in favor of
the requestor, taking into account
uncontested claims or facts to the
contrary; and resolution of the factual
issues(s) in the manner sought by the
requestor would be adequate to justify
the action requested (40 CFR 178.32).
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XIII. Statutory and Executive Order
Reviews
This final rule establishes an
exemption from the tolerance
requirement under FFDCA section
408(d) in response to a petition
submitted to the Agency. The Office of
Management and Budget (OMB) has
exempted these types of actions from
review under Executive Order 12866,
entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993).
Because this rule has been exempted
from review under Executive Order
12866 due to its lack of significance,
this rule is not subject to Executive
Order 13211, Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use (66
FR 28355, May 22, 2001). This final rule
does not contain any information
collections subject to OMB approval
under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any
unfunded mandate as described under
Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public
Law 104–4). Nor does it require any
special considerations under Executive
Order 12898, entitled Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations (59 FR 7629, February 16,
1994); or OMB review or any Agency
action under Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are
established on the basis of a petition
under FFDCA section 408(d), such as
the exemption in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the
Agency has determined that this action
will not have a substantial direct effect
on States, on the relationship between
the national government and the States,
or on the distribution of power and
responsibilities among the various
levels of government, as specified in
Executive Order 13132, 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
PO 00000
Frm 00034
Fmt 4700
Sfmt 4700
development of regulatory policies that
have federalism implications.’’‘‘Policies
that have federalism implications’’ is
defined in the Executive Order to
include regulations that have
‘‘substantial direct effects on the States,
on the relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government.’’ This final rule
directly regulates growers, food
processors, food handlers and food
retailers, not States. This action does not
alter the relationships or distribution of
power and responsibilities established
by Congress in the preemption
provisions of FFDCA section 408(n)(4).
For these same reasons, the Agency has
determined that this rule does not have
any ‘‘tribal implications ’’ as described
in Executive Order 13175, entitled
Consultation and Coordination with
Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive
Order 13175, requires EPA to develop
an accountable process to ensure
‘‘meaningful and timely input by tribal
officials in the development of
regulatory policies that have tribal
implications.’’‘‘Policies that have tribal
implications’’ is defined in the
Executive Order to include regulations
that have ‘‘substantial direct effects on
one or more Indian tribes, on the
relationship between the Federal
Government and the Indian tribes, or on
the distribution of power and
responsibilities between the Federal
Government and Indian tribes.’’ This
rule will not have substantial direct
effects on tribal governments, on the
relationship between the Federal
Government and Indian tribes, or on the
distribution of power and
responsibilities between the Federal
Government and Indian tribes, as
specified in Executive Order 13175.
Thus, Executive Order 13175 does not
apply to this rule.
XIV. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., as added by the Small
Business Regulatory Enforcement
Fairness Act of 1996, generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report, which includes a
copy of the rule, to each House of the
Congress and to the Comptroller General
of the United States. EPA will submit a
report containing this rule and other
required information to the U.S. Senate,
the U.S. House of Representatives, and
the Comptroller General of the United
States prior to publication of this final
rule in the Federal Register. This final
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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 record keeping
requirements.
Dated: June 27, 2005.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR Chapter I is
amended as follows:
I
Follow the detailed
instructions as provided under
ADDRESSES in the Federal Register
document of May 18, 2005.
ADDRESSES:
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
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. Section 180.950 table in paragraph
(e) is amended by adding alphabetically
the following entries to read as follows:
I
A. Does this Action Apply to Me?
The Agency included in the final rule
a list of those who may be potentially
affected by this action. If you have
questions regarding the applicability of
this action to a particular entity, consult
the person listed under the FOR FURTHER
INFORMATION CONTACT.
B. How Can I Access Electronic Copies
of this Document and Other Related
Information?
*
*
*
*
*
In addition to using EDOCKET at
(e)* * *
https://www.epa.gov/edocket/, you may
access this Federal Register document
Chemical Name
CAS No.
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
*
*
*
*
*
https://www.epa.gov/fedrgstr/. A
Alpha - cyclodextrin .................. 10016–20–3 frequently updated electronic version of
*
*
*
*
*
40 CFR part 180 is available at E-CFR
Beta Site Two at https://
Beta - cyclodextrin ....................
7585–39–9 www.gpoaccess.gov/ecfr/.
§ 180.950 Tolerance exemptions for
minimal risk active and inert ingredients.
*
*
*
*
*
Gamma - cyclodextrin ..............
*
*
*
*
17465–86–0
*
[FR Doc. 05–13263 Filed 7–5–05; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[OPP–2005–0109; FRL–7721–1]
Dimethyl Ether; Exemption from the
Requirement of a Tolerance; Technical
Correction
Environmental Protection
Agency (EPA).
ACTION: Final rule; technical correction.
AGENCY:
SUMMARY: EPA issued a final rule in the
Federal Register of May 18, 2005,
establishing a tolerance exemption for
dimethyl ether (methane, oxybis-). This
document is being issued to correct the
CAS Reg. No. for dimethyl ether.
DATES: This final rule is effective on July
6, 2005.
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II. What Does this Correction Do?
A tolerance exemption for dimethyl
ether (methane, oxybis-) was established
in the Federal Register of May 18, 2005,
(70 FR 28436), (FRL–7711–4). In that
document the CAS Reg. No. in the
tolerance exemption expression was
given as 115–10–06. It should be 115–
10–6 as expressed in the preamble.
III. Why is this Correction Issued as a
Final Rule?
Section 553 of the Administrative
Procedure Act (APA), 5 U.S.C.
553(b)(B), provides that, when an
Agency for good cause finds that notice
and public procedure are impracticable,
unnecessary or contrary to the public
interest, the agency may issue a final
rule without providing notice and an
opportunity for public comment. EPA
has determined that there is good cause
for making today’s technical correction
final without prior proposal and
opportunity for comment, because EPA
is merely correcting a typographical
error in a previously-published final
rule in the Chemical Abstracts Service
(CAS) numerical designation for a
chemical. Notice and public procedures
PO 00000
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38785
are unnecessary for such a minor
change. The initial notice for the final
rule and the final rule clearly identified
the chemical by name. EPA finds that
this constitutes good cause under 5
U.S.C. 553(b)(B).
IV. Do Any of the Statutory and
Executive Order Reviews Apply to this
Action?
This final rule implements a technical
correction to the CFR., and it does not
otherwise impose or amend any
requirements. As such, the Office of
Management and Budget (OMB) has
determined that a technical correction is
not a ‘‘significant regulatory action’’
subject to review by OMB under
Executive Order 12866, entitled
Regulatory Planning and Review (58 FR
51735, October 4, 1993). Nor does this
final rule contain any information
collection requirements 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).
Since the Agency has made a ‘‘good
cause’’ finding that this action is not
subject to notice-and-comment
requirements under the APA or any
other statute (see Unit III.), this action
is not subject to provisions of the
Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.).
This action will not result in
environmental justice related issues and
does not, therefore, 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).
Since this action is not a ‘‘significant
regulatory action’’ as defined by
Executive Order 12866; it does not
require 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), and
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 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).
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]]>Agencies
[Federal Register Volume 70, Number 128 (Wednesday, July 6, 2005)]
[Rules and Regulations]
[Pages 38780-38785]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-13263]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2002-0294; FRL-7720-9]
Alpha-cyclodextrin, Beta-cyclodextrin, and Gamma-cyclodextrin;
Exemption from the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance under 40 CFR 180.950 for residues of alpha-cyclodextrin,
beta-cyclodextrin, and gamma-cyclodextrin when used in or on various
food commodities. Wacker Specialties submitted a petition to EPA under
the Federal Food, Drug, and Cosmetic Act
[[Page 38781]]
(FFDCA), as amended by the Food Quality Protection Act (FQPA) of 1996,
requesting an exemption from the requirement of a tolerance. This
regulation eliminates the need to establish a maximum permissible level
for residues of alpha-cyclodextrin, beta- cyclodextrin, and gamma-
cyclodextrin.
DATES: This regulation is effective July 6, 2005. Objections and
requests for hearings must be received on or before September 6, 2005.
ADDRESSES: To submit a written objection or hearing request follow the
detailed instructions as provided in Unit VIII. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under docket
identification (ID) number OPP-2002-0294. 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: Rame Cromwell, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-9068; e-mail address: cromwell.rame@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 Access Electronic Copies of this Document and Other
Related Information?
In addition to using EDOCKET (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 November 14, 2002 (67 FR 220) (FRL-7279-
3), EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (2E6514) by Wacker Specialities, 3301 Sutton Road, Adrian, MI,
49221-9397. The petition requested that residues of a certain pesticide
chemical in or on various food commodities be exempted from the
requirement of a tolerance. This notice included a summary of the
petition prepared by the petitioner Wacker Specialties. No comment was
submitted.
Section 408(c)(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(c)(2)(A)(ii) defines ``safe'' to
mean that ``there is a reasonable certainty that no harm will result
from aggregate exposure to the pesticide chemical residue, including
all anticipated dietary exposures and all other exposures for which
there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Pursuant to section 408(c)(2)(B), in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
section 408(b)(2)(C), which 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 establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risk 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.
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of the pesticide chemical. Second, EPA examines exposure to
the pesticide through food, drinking water, and through other exposures
that occur as a result of pesticide use in residential settings.
III. Inert ingredient Definition
Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.
[[Page 38782]]
IV. Description of Alpha-cyclodextrin, Beta-cyclodextrin, and Gamma-
cyclodextrin
Alpha-cyclodextrin is a non-reducing cyclic saccharide comprised of
six glucose units linked by alpha-1,4 bonds. It is produced by the
action of cyclodextrin glucosyltransferase (CGTase) on hydrolyzed
starch syrups at neutral pH and moderate temperatures. Beta-
cyclodextrin is a cyclic heptamer composed of seven glucose units
joined ``head-to-tail'' by alpha-1,4 links. Gamma-cyclodextrin is a
ring-shaped molecule made up of eight glucose units linked by alpha-1,4
bonds. Alpha-cyclodextrin, beta-cyclodextrin, and gamma-cyclodextrin
are naturally occurring compounds derived from the degradation of
starch by the glucosyltransferase enzyme (CGTase). They are formed
naturally from bacteria and synthetically. The annular (or doughnut-
shaped) structure provides a hydrophobic cavity that allows formulation
of inclusion complexes with a variety of non-polar organic molecules of
appropriate size. The hydrophobic nature of the outer surface of the
cyclic structure makes the compounds water soluble. The hydrophobic
cavity and the hydrophilic outer surface form the basis for its use in
the food industry.
V. Toxicological Profile
Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness and reliability
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children.
The Joint Expert Food Committee Additives (JEFCA) is an
international expert scientific committee that is administered jointly
by the Food and Agriculture Organization of the United Nations (FAO)
and the World Health Organization (WHO). In the Food Additive Series
32, 42, and 48, JEFCA reviewed alpha-, beta-, and gamma-cyclodextrins
and assigned an acceptable daily intake (ADI) of ``not specified'' to
alpha-cyclodextrin. As to beta-cyclodextrin, a temporary ADI of 0-6
milligrams/kilogram (mg/kg) was allocated, based on a no adverse
observed effect level (NAOEL) of 2.5% in the diet (equal to 1,230 mg/
kg/bwt day) in the study of dogs using a safety factor of 200. As to
gamma-cyclodextrin, there were sufficient data to allocate a temporary
ADI of ``not specified.'' A ``not specified'' designation is used to
refer to a food substance of very low toxicity, with, on the basis of
the available data (chemical, biochemical, and other) and the total
dietary intake of the substance, does not, in the opinion of the
Committee, represent a hazard to health. These compounds are natural
occurring cyclic non-reducing torus-shaped maltooligosaccharides. They
originate from the decomposition of starch by a bacterial enzyme called
cyclodextrin glycosyltransferase. Alpha-, beta-, and gamma-
cyclodextrins are comprised of D-glucose molecules.
In its May 20, 2003, response to a Generally Recognized as Safe
(GRAS) notification, the Food and Drug Administration (FDA) had no
questions regarding a conclusion by qualified experts that alpha-,
beta-, and gamma- cyclodextrins meet appropriate food grade
specifications and if manufactured in accordance with good
manufacturing practices are generally recognized as safe.
Alpha-cyclodextrin was examined by JEFCA for its ability to induce
ocular irritation in albino rabbits in two separate studies. In the
first study, a dose of 0.062 g instilled in the conjuctival cul-de-sac
of the right eye of three rabbits was irritating but not corrosive. In
the second study, two groups of three rabbits were given alpha-
cyclodextrin as a 14.5% or a 50% dilution in demineralized water. No or
minimal irritation was found in the eyes and there was no corrosion.
A sample of 0.5 of alpha-cyclodextrin moistened with tap water was
applied to the shaven backs and flanks of three albino rabbits for 4
hours under a semi-occlusive dressing. No skin irritation was observed
for up to 72 hours. Similarly, in guinea-pigs, a 10% or 30% solution of
alpha-cyclodextrin induced no signs of sensitization in the dermally
induced animals.
Short-term (28-day and 90-day) studies of toxicity indicated that
alpha-cyclodextrin has little effect when given orally to rats and
dogs. Alpha-cyclodextrin is not digested in the gastrointestinal tract
but is fermented by the intestinal micro flora. Absorbed alpha-
cyclodextrin is excreted rapidly in the urine.
Studies conducted with mice, rabbits, and rats with alpha-
cyclodextrin at concentrations of up to 20% did not indicate
teratogenic effects.
Beta-cyclodextrin of 0.5 g moistened with 0.5 ml saline was applied
to shaved dorsal skin of 3 white rabbits under occlusion for 24 hours.
The mean primary irritation score was 0.50 (minimally irritating), and
there were no eschar or oedma and the treatment sites were normal by 24
hours after removal of the pad containing the chemical. A primary
dermal irritation study in albino rabbits used an abraded skin
protocol, and the index of primary cutaneous irritation which was
obtained (0.01) classified beta- cyclodextrin as non-irritant.
In an ocular irritancy/corrosion test in albino rabbits, beta-
cyclodextrin was classified as slightly irritating.
Gamma-cyclodextrin was not irritating or corrosive to the eyes of
albino rabbits. In a skin sensitization assay in guinea-pigs, a 30%
solution induced no signs of sensitization.
Short term (28-day and 90-day) studies of toxicity indicate that
gamma-cyclodextrin has little toxicity when given orally to rats or
dogs. Studies conducted in rats and rabbits with gamma-cyclodextrin at
doses up to 20% of the diet did not indicate any teratogenic effects.
Similarly, the results of a battery of studies of genotoxicity were
negative. Long-term studies of toxicity, carcinogenicity, and
reproductive toxicity have not been conducted, but, given the rapid
metabolism of this substance to glucose and its lack of genotoxicity,
such studies were not required for an evaluation.
VI. Aggregate Exposure
1. Food. Alpha-cyclodextrin, beta-cyclodextrin, and gamma-
cyclodextrin are naturally occurring and are used as food additives.
The following was taken from the WHO INCHEM (Food Additives Series 32,
42, 48). Alpha-cyclodextrin is used as a carrier for flavors, colors,
and sweeteners in foods such as dry mixes, baked goods, and instant
teas and coffee, as a stabilizer for flavors, colors, vitamins, and
polyunsaturated fatty acids in dry mixes and dietary supplements (< 1%
of the final product), as a flavor modifier in soya milk (< 1%), and as
an absorbent (breath freshener) in confectionery products (10-15% of
the final product).
Beta-cyclodextrin may serve as a stabilizer of food flavors, food
colors and some vitamins.
Gamma-cyclodextrin is used as a carrier for flavors, sweeteners,
and colors, and it has been proposed for use in this manner in dry
mixes for beverages, soups, dressings, gravies and fillings. It is also
used in instant coffee, tea, chewing gum, crackers, and spices. It is
also proposed for use as a carrier for vitamins and polyunsaturated
fatty acids in dry food mixes and in dietary supplements.
2. Drinking water exposure. Alpha-, beta-, and gamma-cyclodextrins
are highly soluble in water, non-volatile,
[[Page 38783]]
have a low air: water partition coefficient, and will not be mobile in
soils and sediments. Cyclodextrins will rapidly biodegrade with primary
degradation occurring in a matter of hours and ultimate degradation
occurring in days. No significant exposure to alpha-, beta-, and gamma-
cyclodextrins via drinking water is anticipated.
Due to the high molecular weight of the alpha-, beta-, and gamma-
cyclodextrins, absorption through the skin is expected to be
negligible. Therefore, no significant systemic exposure is anticipated
for these chemicals from residential use as inert ingredients in
pesticide products.
VII. Cumulative Effects
Section 408(b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance exemption, the
Agency consider ``available information'' concerning the cumulative
effects of a particular chemical's residues and other substances that
have a common mechanism of toxicity.
Unlike other pesticides chemicals for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity, EPA
has not made a common mechanism of toxicity finding as to alpha-, beta-
, and gamma- cyclodextrins and any other substances and they do not
appear to produce a toxic metabolite produced by other substances. For
the purpose of this tolerance action, therefore, EPA has not assumed
that alpha-, beta-, and gamma-cyclodextrins have 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 determination and procedures for cumulating effects
from substances found to have a common mechanism on EPA's website at
https://www.epa.gov/pesticides/cumulative/.
VIII. Safety Factor for Infants and Children
FFDCA section 408 provides that EPA shall apply an additional
tenfold margin of safety for infants and children in the case of
threshold effects to account for prenatal and postnatal toxicity and
the completeness of the data base unless EPA concludes that a different
margin of safety will be safe for infants and children. The Agency
believes that alpha-, beta-, and gamma- cyclodextrins to be of low
toxicity. EPA has not used a safety factor analysis to assess the risk,
and therefore the additional tenfold safety factor is unnecessary.
IX. Determination of Safety for U.S. Population, Infants and Children
Based on the available information demonstrating that alpha-, beta-
, and gamma-cyclodextrins are of low toxicity, EPA concludes there is a
reasonable certainty no harm will result to the general population
including infants and children from aggregate exposure to alpha-, beta-
, and gamma- cyclodextrin residues when used as inert ingredients in
pesticide products.
X. Other Considerations
A. Endocrine Disruptors
FQPA requires EPA to develop a screening program to determine
whether certain substances, including all pesticide chemicals (both
inert and active ingredients), ``may have an effect in humans that is
similar to an effect produced by a naturally occurring estrogen, or
such other endocrine effect. . . .'' EPA has been working with
interested stakeholders to develop a screening and testing program as
well as a priority setting scheme. As the Agency proceeds with
implementation of this program, further testing of products containing
alpha-, beta- and gamma-cyclodextrins for endocrine effects may be
required.
B. Analytical Method(s)
An analytical method is not required for enforcement purposes
because the Agency is establishing an exemption from the requirement of
a tolerance without any numerical limitation.
C. Existing Tolerances
There are no existing tolerances or tolerance exemptions for alpha,
beta, and gamma-cyclodextrins.
D. International Tolerances
The Agency is not aware of any country requiring a tolerance for
alpha, beta, or gamma-cyclodextrins nor have any CODEX Maximum Residue
Levels been established for any food crops at this time.
E. Response to Comment
No comments were received regarding the Notice of filling (67 FR
220) (FRL-7279-3).
XI. Conclusions
Based on the available information on alpha-, beta-, and gamma-
cyclodextrin, there is a low likelihood of concern for substantial
exposures to non-target organisms from the use of these chemicals as
inert ingredients in pesticide products. EPA concludes that there is a
reasonable certainty of no harm from aggregate exposure from residues
of alpha-, beta-, and gamma- cyclodextrin. Accordingly, EPA finds that
exempting alpha-, beta-, and gamma- cyclodextrins from the requirement
of tolerance will be safe to the general population and infants and
children.
XII. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) provides essentially
the same process for persons to ``object'' to a regulation for an
exemption from the requirement of a tolerance issued by EPA under new
section 408(d), as was provided in the old FFDCA sections 408 and 409.
However, the period for filing objections is now 60 days, rather than
30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number OPP -2002-0294. 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 September
6, 2005.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
[[Page 38784]]
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900L),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Suite 350, 1099 14th St., NW.,
Washington, DC 20005. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
2. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VIII.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-2002 -0294, 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.
In person or by courier, bring a copy to the location of the PIRIB
described in ADDRESSES. You may also send an electronic copy of your
request via e-mail to: opp-docket@epa.gov. Please use an ASCII file
format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
XIII. Statutory and Executive Order Reviews
This final rule establishes an exemption from the tolerance
requirement under FFDCA section 408(d) in response to a petition
submitted to the Agency. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4,
1993). Because this rule has been exempted from review under Executive
Order 12866 due to its lack of significance, this rule is not subject
to Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001). This final rule does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or
contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor
does it require any special considerations under Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994);
or OMB review or any Agency action under Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997). This action does not
involve any technical standards that would require Agency consideration
of voluntary consensus standards pursuant to section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (NTTAA),
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under FFDCA section 408(d), such as the exemption in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, 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 FFDCA section 408(n)(4). For these same reasons, the Agency has
determined that this rule does not have any ``tribal implications '' as
described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal
implications.''``Policies that have tribal implications'' is defined in
the Executive Order to include regulations that have ``substantial
direct effects on one or more Indian tribes, on the relationship
between the Federal Government and the Indian tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian tribes.'' This rule will not have substantial
direct effects on tribal governments, on the relationship between the
Federal Government and Indian tribes, or on the distribution of power
and responsibilities between the Federal Government and Indian tribes,
as specified in Executive Order 13175. Thus, Executive Order 13175 does
not apply to this rule.
XIV. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
[[Page 38785]]
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 record
keeping requirements.
Dated: June 27, 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. Section 180.950 table in paragraph (e) is amended by adding
alphabetically the following entries to read as follows:
Sec. 180.950 Tolerance exemptions for minimal risk active and inert
ingredients.
* * * * *
(e)* * *
------------------------------------------------------------------------
Chemical Name CAS No.
------------------------------------------------------------------------
* * * * *
Alpha - cyclodextrin....................................... 10016-20-3
* * * * *
Beta - cyclodextrin........................................ 7585-39-9
* * * * *
Gamma - cyclodextrin....................................... 17465-86-0
* * * * *
------------------------------------------------------------------------
[FR Doc. 05-13263 Filed 7-5-05; 8:45 am]
BILLING CODE 6560-50-S
