[Federal Register Volume 70, Number 95 (Wednesday, May 18, 2005)]
[Rules and Regulations]
[Pages 28447-28452]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-9479]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2005-0110; FRL-7710-3]


Pinene Polymers; Exemption from the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes exemptions from the requirement of 
a tolerance for residues of several alpha- and/or beta-pinene polymers 
when used as inert ingredients in or on growing crops and when applied 
to raw agricultural commodities after harvest. Hercules, Inc. submitted 
a petition to EPA under the Federal Food, Drug, and Cosmetic Act 
(FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA), 
requesting an exemption from the requirement of a tolerance. This 
regulation eliminates the need to establish a maximum permissible level 
for residues of alpha and/or beta-pinene polymers.

DATES: This regulation is effective May 18, 2005. Objections and 
requests for hearings must be received on or before July 18, 2005.

ADDRESSES:  To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit XI. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under Docket 
identification (ID) number OPP-2005-0110. 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: 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:  [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 Get Electronic Documents and Other Related Information?

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

II. Background and Statutory Findings

    In the Federal Register of November 20, 1998 (63 FR 64494) (FRL-
6027-6), EPA issued a notice pursuant to section 408 of FFDCA, 21 
U.S.C. 346a, as amended by FQPA (Public Law 104-170), announcing the 
filing of a pesticide petition (PP 6E4782) by Hercules, Inc. 1313 North 
Market St., Wilmington, DE 19894-0001. The petition requested that 40 
CFR part 180 be amended by establishing an

[[Page 28448]]

exemption from the requirement of a tolerance for residues of alpha- 
and/or beta-pinene polymers for use as an inert ingredient in pesticide 
products. That notice included a summary of the petition prepared by 
the petitioner.
    The Agency interpreted the petitioner's request for an exemption 
for alpha- and/or beta-pinene polymers, as a request to amend the 
existing exemption for beta-pinene polymers to include alpha- and/or 
beta-pinene polymers. In the Notice of Filing the petitioner used only 
the generalized term alpha- and/or beta-pinene polymers and did not 
specifically identify the chemicals by CAS Reg. No. or Name. The alpha- 
and/or beta-pinene polymers considered by the Agency are in the 
following Table.

                          Chemicals Considered
------------------------------------------------------------------------
     Common chemical name      CAS Nomenclature          CAS No.
------------------------------------------------------------------------
Alpha-pinene polymer           Bicyclo[3.1.1]he               25766-18-1
                                pt-2-ene, 2,6,6-
                                trimethyl-,
                                homopolymer
------------------------------
------------------------------
------------------------------
------------------------------------------------------------------------

    There were no comments received in response to the notice of 
filing.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of the FFDCA 
defines ``safe'' to mean that ``there is a reasonable certainty that no 
harm will result from aggregate exposure to the pesticide chemical 
residue, including all anticipated dietary exposures and all other 
exposures for which there is reliable information.'' This includes 
exposure through drinking water and in residential settings, but does 
not include occupational exposure. Section 408(b)(2)(C) of the FFDCA 
requires EPA to give special consideration to exposure of infants and 
children to the pesticide chemical residue in establishing a tolerance 
and to ``ensure that there is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to the pesticide 
chemical residue * * *.''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. First, EPA determines the 
toxicity of pesticides. Second, EPA examines exposure to the pesticide 
through food, drinking water, and through other exposures that occur as 
a result of pesticide use in residential settings.

III. Inert Ingredient Definition

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

IV. Toxicological Profile

    Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed 
the available scientific data and other relevant information in support 
of this action and considered its validity, completeness and 
reliability and the relationship of this information to human risk. EPA 
has also considered available information concerning the variability of 
the sensitivities of major identifiable subgroups of consumers, 
including infants and children. The nature of the toxic effects caused 
by alpha- and/or beta-pinene polymers are discussed in this unit.
    Alpha- and beta-pinene are bicyclic terpene hydrocarbons. They are 
the major components of turpentine. The two chemicals are closely 
related, having the same empirical formula of 
C10H16 and the same basic ring structure. Alpha- 
and/or beta-pinene polymers are manufactured by various processes that 
increase the molecular weight beyond that of alpha- or beta-pinene and 
include formation of a dimer (two ``pinenes'' in a single molecule), 
formation of a trimer (three ``pinenes'' in a single molecule), or 
polymerization.
    The data considered in this assessment included information 
submitted by the petitioner, and information located by OPP on the 
internet, primarily information prepared by the National Toxicology 
Program (NTP) and the robust summaries for bicyclic terpene 
hydrocarbons submitted in 2002 to EPA by the Terpene Consortium of the 
Flavor and Fragrance High Production Volume Consortia (FFHPVC). The 
Agency evaluated first the toxicity of the alpha- and beta-pinene 
chemicals.
    The toxicity of alpha- and beta-pinene is defined by studies from 
open-literature conducted with alpha-pinene, beta-pinene and various 
alpha- and beta-pinene mixtures. There is also a structure-activity-
relationship (SAR) assessment for alpha-pinene. The findings of the SAR 
assessment are consistent with the studies from open-literature. The 
overall conclusions are the following; however, greater detail on the 
Agency's review and evaluation of the submitted studies and articles 
from open literature are in the Alpha- and Beta-Pinene Science 
Assessment in EDOCKET at (http://www.epa.gov/edocket/).
    Alpha- and beta-pinene are of low acute toxicity via the oral, 
dermal and inhalation routes. Both alpha-and beta-pinene are irritants 
to the skin, eye and mucous membranes. Alpha- and beta-pinene are well-
absorbed by all routes of exposure.
    The subchronic toxicity of alpha- and beta-pinene compounds appears 
to be low. A subchronic oral toxicity study indicated minor changes in 
liver and thryoid weights at the two higher dose levels, which were not 
considered treatment related. There were no effects at approximately 
800 mg/kg/day.

[[Page 28449]]

    Genotoxicity study summaries indicated no evidence of mutagenicity 
in several Salmonella typhimurium reverse mutation assays, one 
unscheduled DNA assay, and one sister chromatid exchange assay. No 
chronic/carcinogenicity studies were identified; however, alpha- and 
beta-pinene are not structurally related to any known carcinogens.
    A mixture primarily of alpha- and beta-pinene was tested in three 
developmental toxicity studies. Summaries of the results of these 
studies report that no maternal or developmental effects were noted in 
mice, hamsters, or rats at the highest dose levels, 560, 600, or 260 
mg/kg/day, respectively. Alpha- and beta-pinene are not structurally 
related to any known developmental/reproductive toxicants.
    The available information does not indicate that any of these 
chemicals are of higher toxicity. For alpha- and beta-pinene, the 
irritation effects are the effects of concern. Such effects are handled 
through use of personal protective equipment. Most of the turpentine 
produced in the United States is made up primarily of alpha-pinene (75 
to 85%). Turpentine is known to act as a central nervous system (CNS) 
depressant, as is typical of certain organic chemicals. Given the 
relationship of turpentine to alpha-pinene, and the relationship of 
alpha- to beta-pinene, by extrapolation, there could be neurotoxicity 
concerns for pinene chemicals from dermal and inhalation exposures. 
Such exposures generally need to be ``high'' and/or ``prolonged'' for 
such toxicity effects to occur. Also, for acute exposures, such 
effects, generally, are reversible. Concerns are for occupational 
exposures since the potential for day in/day out exposure can occur in 
the workplace.
    Few toxicity studies conducted with alpha- and/or beta-pinene 
polymers were located. A structure activity relationship (SAR) 
assessment indicated an overall low concern. The toxicity information 
on alpha- and beta- pinene indicate that these are not substances of 
high toxicity. Polymers composed of alpha and beta-pinene monomers are 
of a low molecular weight, and thus cannot be exempted from the 
requirement of a tolerance using the criteria specified for defining a 
low-risk polymer in 40 CFR 723.250. As previously explained, processes 
used to form an alpha- and/or beta-pinene polymer would increase the 
molecular weight. Greater molecular weight means decreased absorption. 
Alpha- and/or beta-pinene dimers, trimers, or polymers should therefore 
be of even lower toxicity than pure alpha- and beta-pinene.

V. Aggregate Exposures

    In examining aggregate exposure, section 408 of the FFDCA directs 
EPA to consider available information concerning exposures from the 
pesticide residue in food and all other non-occupational exposures, 
including drinking water from ground water or surface water and 
exposure through pesticide use in gardens, lawns, or buildings 
(residential and other indoor uses).
    EPA establishes exemptions from the requirement of a tolerance only 
in those cases where it can be clearly demonstrated that the risks from 
aggregate exposure to pesticide chemical residues under reasonably 
foreseeable circumstances will pose no appreciable risks to human 
health. In order to determine the risks from aggregate exposure to 
pesticide inert ingredients, the Agency considers the toxicity of the 
inert in conjunction with possible exposure to residues of the inert 
ingredient through food, drinking water, and through other exposures 
that occur as a result of pesticide use in residential settings. If EPA 
is able to determine that a finite tolerance is not necessary to ensure 
that there is a reasonable certainty that no harm will result from 
aggregate exposure to the inert ingredient, an exemption from the 
requirement of a tolerance may be established.
    Human beings are exposed to a back-ground level of naturally-
occurring alpha- and beta-pinene. The two chemicals occur together, but 
beta-pinene occurs at lower levels than alpha-pinene. Atmospheric 
concentrations of alpha-pinene have been detected in deciduous and 
coniferous forests, and suburban and urban areas. Alpha-pinene has been 
detected in filberts, chicken, mangos, fresh grapefruit juice (0.054 
ppm), guava, carrots, pistachio, safflower, sorghum, tomato, walnut, 
ginger, celery, unpasteurized orange juice (0.10-1.09 ppm), shrimp, and 
crab.
    Neither alpha- nor beta-pinene are persistent in the environment. 
Given the ready volatilization and rapid degradation of alpha- and 
beta-pinene, it is unlikely to be present in any significant amounts in 
sources of drinking water.
    Exposure to alpha- and beta-pinene can occur from use as a 
fragrance in consumer products (both are components of many essential 
oils) and as a flavoring in foods. However, the naturally-occurring 
exposures to alpha- and beta-pinene are more extensive than such 
anthropogenic exposures. The uses regulated by EPA are much smaller 
than the naturally-occurring exposures.
    For greater detail see the Alpha- and Beta-Pinene Science 
Assessment in EDOCKET at (http://www.epa.gov/edocket/).

VI. Cumulative Effects

    Section 408(b)(2)(D)(v) of the FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to alpha-pinene, beta-pinene, 
or any alpha- and/or beta-pinene polymers. These chemicals do not 
appear to produce a toxic metabolite produced by other substances. 
These are lower toxicity chemicals; therefore, the resultant risks 
separately and/or combined should also be low. For the purposes of this 
action, therefore, EPA has not assumed that alpha-pinene, beta-pinene, 
or any alpha- and/or beta-pinene polymers 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 determinations and procedures for cumulating effects 
from substances found to have a common mechanism on EPA's website at 
http://www.epa.gov/pesticides/cumulative/.

VII. Safety Factor for Infants and Children

    FFDCA section 408 provides that EPA shall apply an additional 
tenfold margin of safety for infants and children in the case of 
threshold effects to account for prenatal and postnatal toxicity and 
the completeness of the data unless EPA concludes that a different 
margin of safety will be safe for infants and children. Three 
developmental toxicity studies (rat, mouse and hamster) conducted using 
a mixture of alpha- and beta-pinenes at high dose levels did not 
identify either maternal or developmental no observed adverse effect 
levels (NOAELs). There are no indications of increased susceptibility. 
These pinene chemicals are not structurally related to any known

[[Page 28450]]

developmental/reproductive toxicants. Therefore, EPA has not used a 
safety factor analysis to assess the risk. For the same reasons a 
tenfold safety factor is unnecessary.

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

    The database considered for this action included mostly toxicity 
data derived using alpha- and beta-pinene. Alpha- and beta-pinene 
exhibit low acute toxicity by the oral, dermal and inhalation routes, 
and low subchronic toxicity. Polymers composed of alpha and beta-pinene 
monomers, even those of low molecular weight, should be even less toxic 
than alpha- and beta-pinene considering that their absorption is 
decreased. Based on the available information on toxicity and exposure, 
EPA concludes that there is a reasonable certainty of no harm from 
aggregate exposure to residues of alpha-pinene, beta-pinene, and alpha- 
and/or beta-pinene polymers. EPA finds that amending the existing 
exemption from the requirement of a tolerance for beta-pinene polymers 
to include alpha- and/or beta-pinene polymers will be safe for the 
general population including infants and children.

IX. Other Considerations

A. Endocrine Disruptors

    FQPA requires EPA to develop a screening program to determine 
whether certain substances, including all pesticide chemicals (both 
inert and active ingredients), ``may have an effect in humans that is 
similar to an effect produced by a naturally occurring estrogen, or 
such other endocrine effect * * *'' EPA has been working with 
interested stakeholders to develop a screening and testing program as 
well as a priority setting scheme. As the Agency proceeds with 
implementation of this program, further testing of products containing 
alpha-pinene, beta-pinene, or any alpha- and/or beta-pinene polymers 
for endocrine effects may be required.

B. Analytical Method(s)

    An analytical method is not required for enforcement purposes since 
the Agency is establishing an exemption from the requirement of a 
tolerance without any numerical limitation.

C. Existing Exemptions

    There is an existing tolerance exemption for B-pinene polymers in 
40 CFR 180.910 when applied to growing crops or to raw agricultural 
commodities after harvest.

D. International Tolerances

    The Agency is not aware of any country requiring a tolerance for 
alpha- and/or beta-pinene polymers nor have any CODEX Maximum Residue 
Levels (MRLs) been established for any food crops at this time.

X. Conclusions

    Therefore, exemptions from the requirement for a tolerance are 
established for alpha-pinene polymer (CAS Reg. No. 25766-18-1), beta-
pinene polymer (CAS Reg. No. 25719-60-2), copolymer of alpha- and beta-
pinene (CAS Reg. No. 31393-98-3), and terpenes and terpenoids, 
turpentine oil, alpha-pinene fraction, polymd. (CAS Reg. No. 70750-57-
1).

XI. Objections and Hearing Requests

    Under section 408(g) of FFDCA, as amended by 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 FQPA, 
EPA will continue to use those procedures, with appropriate 
adjustments, until the necessary modifications can be made. The new 
section 408(g) of FFDCA provides essentially the same process for 
persons to ``object'' to a regulation for an exemption from the 
requirement of a tolerance issued by EPA under new section 408(d) of 
FFDCA, as was provided in the old FFDCA sections 408 and 409 of FFDCA. 
However, the period for filing objections is now 60 days, rather than 
30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2005-0110 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 July 18, 
2005.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900L), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Suite 350, 1099 14\th\ St., NW., 
Washington, DC 20005. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
    2. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit XI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in ADDRESSES. Mail your 
copies, identified by docket ID number OPP-2005-0110, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in ADDRESSES. You may also send an electronic copy of 
your request via e-mail to: [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

[[Page 28451]]

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).

XII. Statutory and Executive Order Reviews

    This final rule establishes an exemption from the tolerance 
requirement under section 408(d) of the FFDCA in response to a petition 
submitted to the Agency. The Office of Management and Budget (OMB) has 
exempted these types of actions from review under Executive Order 
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 
1993). Because this rule has been exempted from review under Executive 
Order 12866 due to its lack of significance, this rule is not subject 
to Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001). This final rule does not contain any information 
collections subject to OMB approval under the Paperwork Reduction Act 
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or 
contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor 
does it require any special considerations under Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994); 
or OMB review or any Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). This action does not 
involve any technical standards that would require Agency consideration 
of voluntary consensus standards pursuant to section 12(d) of the 
National Technology Transfer and Advancement Act of 1995 (NTTAA), 
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under section 408(d) of the FFDCA, such as the exemption in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601  et 
seq.) do not apply. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled Federalism 
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by State and local officials in the development of regulatory policies 
that have federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of the FFDCA. For these same reasons, the Agency 
has determined that this rule does not have any ``tribal implications'' 
as described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
Order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

XIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: April 27, 2005.

Betty Shackleford,
Acting Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.910, the table is amended by removing the current B-
pinene polymer entry and by alphabetically adding the following entries 
to read as follows:


Sec.  180.910  Inert ingredients used pre- and post-harvest; exemptions 
from the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
                              * * * * * * *
Bicyclo[3.1.1]hept-2-ene, 2,6,6-  ..................  Surfactants,
 trimethyl-, homopolymer (Alpha-                       related adjuvants
 pinene, homopolymer )(CAS Reg.                        of surfactants
 No. 25766-18-1),.
Bicyclo[3.1.1]heptane, 6,6-       ..................  Surfactants,
 dimethyl-2-methylene-,                                related adjuvants
 homopolymer (Beta-pinene,                             of surfactants
 homopolymer) (CAS Reg. No.
 25719-60-2),.

[[Page 28452]]

 
Bicyclo[3.1.1]hept-2-ene, 2,6,6-  ..................  Surfactants,
 trimethyl-, polymer with 6,6-                         related adjuvants
 dimethyl-2- methylenebicyclo                          of surfactants
 [3.1.1] heptane (Copolymer of
 alpha- and beta-pinene) (CAS
 Reg. No. 31393-98-3),.
                              * * * * * * *
Terpenes and terpenoids,          ..................  Surfactants,
 turpentine oil, alpha-pinene                          related adjuvants
 fraction, polymd. (CAS Reg. No.                       of surfactants
 70750-57-1)..
                              * * * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. 05-9479 Filed 5-17-05; 8:45 am]
BILLING CODE 6560-50-S