[Federal Register Volume 70, Number 128 (Wednesday, July 6, 2005)]
[Rules and Regulations]
[Pages 38780-38785]
From the Federal Register Online via the Government Publishing 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 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: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     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 (http://www.epa.gov/edocket/), you may 
access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register '' listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 
CFR part 180 is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.

II. Background and Statutory Findings

    In the Federal Register of 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 
http://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: [email protected]. Please use an ASCII file 
format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

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

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

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