[Federal Register Volume 68, Number 24 (Wednesday, February 5, 2003)]
[Rules and Regulations]
[Pages 5835-5839]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-2431]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2002-0308; FRL-7287-2]


6-Benzyladenine; Temporary Exemption From the Requirement of a 
Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY:  This regulation establishes a temporary exemption from the 
requirement of a tolerance for residues of the biochemical pesticide 6-
benzyladenine on apples and pistachios when applied/used in accordance 
with the Experimental Use Permit 73049-EUP-2. Valent BioSciences 
Corporation submitted a petition to EPA under the Federal Food, Drug, 
and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act 
of 1996 (FQPA), requesting the temporary tolerance exemption. This 
regulation eliminates the need to establish a maximum permissible level 
for residues of 6-benzyladenine. The temporary tolerance exemption will 
expire on January 31, 2005.

DATES: This regulation is effective February 5, 2003. Objections and 
requests for hearings, identified by docket ID number OPP-2002-0308, 
must be received by EPA on or before April 7, 2003.

ADDRESSES: Written objections and hearing requests may be submitted 
electronically, by mail, or through hand delivery/courier. Follow the 
detailed instructions as provided in Unit VIII. of the SUPPLEMENTARY 
INFORMATION.

FOR FURTHER INFORMATION CONTACT: Denise Greenway, Biopesticides and 
Pollution Prevention Division (7511C), Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-8263; 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:
    [sbull] Crop production (NAICS 111)
    [sbull] Animal production (NAICS 112)
    [sbull] Food manufacturing (NAICS 311)
    [sbull] Pesticide manufacturing (NAICS 32532)
    [sbull] Antimicrobial pesticides (NAICS 32561)
    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 Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket identification (ID) number OPP-2002-0308. The 
official public docket consists of the documents specifically 
referenced in this action, any public comments received, and other 
information related to this action. Although a part of the official 
docket, the public docket does not include Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. The official public docket is the collection of materials 
that is available for public viewing at the Public Information and 
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 
1921 Jefferson Davis Hwy., 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.
    2. Electronic access. 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 http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a 
beta site currently under development.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.

II. Background and Statutory Findings

    In the Federal Register of March 28, 2002 (67 FR 14948) (FRL-6828-
9), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 
346a, as amended by FQPA (Public Law 104-170), announcing the filing of 
a pesticide tolerance petition (PP 2G6378)

[[Page 5836]]

by Valent BioSciences Corporation, 870 Technology Way, Suite 100, 
Libertyville, IL 60048. This notice included a summary of the petition 
prepared by the petitioner Valent BioSciences Corporation. There were 
no comments received in response to the notice of filing.
    The petition requested that 40 CFR part 180 be amended to expand 
the existing tolerance exemption by establishing a temporary exemption 
from the requirement of a tolerance for residues of 6-benzyladenine.
    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 exemption is ``safe.'' Section 408(c)(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....'' Additionally, section 408(b)(2)(D) of the FFDCA 
requires that 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.''
    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. 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 toxicological profile for 6-benzyladenine has been previously 
published by the Agency in the N6-Benzyladenine (synonymous with the 
subject active ingredient, 6-benzyladenine) Reregistration Eligibility 
Decision (RED) document of June 1994 (Ref. 1). The summarized values 
and categories for the various studies for the technical active 
ingredient are presented here.
    1. Acute toxicity. Toxicity Category III was assigned to the acute 
oral toxicity study in the rat (LD50 = 1.3 grams/kilogram 
(g/kg)), and in the eye irritation study in the rabbit (moderate 
irritant). Toxicity Category IV was assigned to the acute dermal 
toxicity study in the rabbit (LD50 > 5 g/kg), the acute 
inhalation toxicity study in the rat (LC50 = 5.2 milligrams/
liter (mg/L)), and in the dermal irritation study in the rabbit (slight 
irritant). Additionally, from a dermal sensitization study in the 
guinea pig, it was determined that N6-benzyladenine is not a dermal 
sensitizer.
    2. Genotoxicity. From three mutagenicity studies (Ames test, mouse 
micronucleus assay, and unscheduled DNA synthesis assay in the rat), it 
was determined that N6-benzyladenine is not mutagenic.
    3. Developmental toxicity. The no observed adverse effect levels 
(NOAEL) and the lowest observed adverse effect levels (LOAEL) for 
maternal and developmental toxicity in rats, respectively, were found 
to be 50 and 175 mg/kg of body weight (bwt)/day, respectively.
    4. Subchronic toxicity. For rats of both sexes, the NOAEL was 
approximately 111 mg/kg of bwt/day and the LOAEL was approximately 304 
mg/kg of bwt/day.

IV. 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).

A. Dietary Exposure

    1. Food. Apple and pistachio field trials performed in support of 
the temporary tolerance exemption request and the associated 
experimental use permit yielded acceptable magnitude of the residue 
data (Ref. 2). Residues were below the limit of quantitation (LOQ) for 
pistachios treated with a total of 60 g of active ingredient (a.i.) per 
acre. In apples, residues of 6-benzyladenine were consistently near the 
LOQ. However, residues did not increase in processed commodities 
(relative to the levels on the raw commodity), and were below the LOQ. 
Thus, the apple field data are adequate to support the temporary 
tolerance exemption petition and experimental program to apply <=182 
grams of active ingredient per acre per season. Also, because 
application precedes harvest by 2 months for pistachio and by 
approximately 2.5 months for apple, the potential for dietary exposure 
is reduced.
    Due to the low anticipated dietary intake of 6-benzyladenine 
residues relative to the chronic and acute population adjusted doses 
(see Unit VI, below), and the fact that actual exposure will probably 
be considerably less because the dietary exposure analysis was based on 
worst-case assumptions, it is highly unlikely that the proposed new 
uses of 6-benzyladenine on apples and pistachios will result in adverse 
effects to human health.
    2. Drinking water exposure. The proposed uses on apples and 
pistachios are not expected to add potential exposure to drinking 
water. Soil leaching studies have suggested that 6-benzyladenine is 
relatively immobile (Ref. 3), absorbing to sediment. Residues reaching 
surface waters from field runoff should quickly absorb to sediment 
particles and be partitioned from the water column. 6-Benzyladenine 
also has low solubility in water, 76 +/- 2 mg/L at 20[deg] C (Ref. 2), 
and detections in ground water are not expected. Together, these data 
indicate that residues are not expected in drinking water.

B. Other Non-Occupational Exposure

    The potential for non-dietary exposure to 6-benzyladenine residues 
for the general population, including infants and children, is unlikely 
because the uses are limited to experimental applications in apple and 
pistachio orchards. Because 6-benzyladenine is a naturally occurring 
cytokinin plant regulator (Ref. 4, 5, 6, 7, and 8), it is a normal part 
of the human diet. The proposed experimental use rates are well below 
the toxicity NOAELs. The residues indicate dietary exposures that are 
0.03% and 0.01% of the chronic and acute population adjusted doses, 
respectively. Therefore, while there exists a great likelihood of prior 
exposure for most, if not all, individuals to 6-benzyladenine, any 
increased exposure due to the proposed

[[Page 5837]]

experimental product would be negligible due to the lack of residue in 
comparison with the toxicity NOAELs.

V. Cumulative Effects

    The Agency has considered the cumulative effects of 6-benzyladenine 
and other substances in relation to a common mechanism of toxicity. 
These considerations include the possible cumulative effects of such 
residues on infants and children. Based on the available information 
and data for 6-benzyladenine, no mammalian toxicity is expected at the 
proposed experimental use rates. Therefore, no cumulative effects are 
expected.

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

    1. U. S. population. The analysis estimated that the chronic 
exposures for the overall U.S. population was 0.000014 mg/kg/day (0.03% 
of the chronic population adjusted dose (cPAD)). The acute dietary 
estimated exposure was 0.000069 mg/kg/day (0.01% of the acute 
population adjusted dose (aPAD)) for the overall U.S. population. 
Critical exposure commodity analysis showed that apple juice 
contributed the most to dietary exposure for the overall population. 
Due to the low anticipated dietary intake of 6-benzyladenine residues 
relative to the chronic and acute population adjusted doses, and the 
fact that actual exposure will probably be considerably less because 
the dietary exposure analysis was made based on worst-case assumptions, 
it is likely that the proposed new uses of 6-benzyladenine on apples 
and pistachios will not result in adverse effects to human health.
    2. Infants and children. The analysis estimated that the chronic 
exposures for the most highly exposed subgroup, non-nursing infants, 
was 0.000085 mg/kg/day (0.2% of the cPAD). The acute dietary estimated 
exposure was 0.000361 mg/kg/day (0.07% of aPAD) for the most highly 
exposed subgroup, non-nursing infants. Critical exposure commodity 
analysis showed that apple juice contributed the most to dietary 
exposure for all infants. Due to the low anticipated dietary intake of 
6-benzyladenine residues relative to the chronic and acute PAD, and the 
fact that actual exposure will probably be considerably less because 
the dietary exposure analysis was made based on worst-case assumptions, 
it is likely that the proposed new uses of 6-benzyladenine on apples 
and pistachios will not result in adverse effects to human health.

VII. Other Considerations

A. Endocrine Disruptors

    EPA is required under the FFDCA as amended by FQPA to develop a 
screening program to determine whether certain substances (including 
all pesticide active and other ingredients) ``may have an effect in 
humans that is similar to an effect produced by a naturally occurring 
estrogen, or other such endocrine effects as the Administrator may 
designate.'' Following the recommendations of its Endocrine Disruptor 
Screening and Testing Advisory Committee (EDSTAC), EPA determined that 
there is no scientific basis for including, as part of the program, the 
androgen and thyroid hormone systems in addition to the estrogen 
hormone system. EPA also adopted EDSTAC's recommendation that the 
program include evaluations of potential effects in wildlife. For 
pesticide chemicals, EPA will use FIFRA and, to the extent that effects 
in wildlife may help determine whether a substance may have an effect 
in humans, FFDCA authority to require wildlife evaluations. As the 
science develops and resources allow, screening of additional hormone 
systems may be added to the Endocrine Disruptor Screening Program 
(EDSP). When the appropriate screening and/or testing protocols being 
considered under the Agency's EDSP have been developed, 6-benzyladenine 
may be subjected to additional screening and/or testing to better 
characterize effects related to endocrine disruption.
    Based on available data, no endocrine system-related effects have 
been identified with consumption of 6-benzyladenine. To date, there is 
no evidence to suggest that 6-benzyladenine affects the immune system, 
functions in a manner similar to any known hormone, or that it acts as 
an endocrine disruptor.

B. Analytical Method

    The Agency is establishing a temporary exemption from the 
requirement of a tolerance for the reasons stated above. For the same 
reasons, the Agency has concluded that an analytical method is not 
required for enforcement purposes for 6-benzyladenine.

C. Codex Maximum Residue Level

    Currently, there are no Codex, Canadian or Mexican maximum residue 
levels for residues of 6-benzyladenine in/on apples or pistachios.

VIII. Conclusions

    Based on the toxicology information submitted and reviewed 
previously, and summarized in the June 1994 N6-Benzyladenine RED (Ref. 
1), there is a reasonable certainty that no harm will result from 
aggregate exposure of residues of 6-benzyladenine to the U.S. 
population, including infants and children, under reasonably 
foreseeable circumstances, when the biochemical pesticide is used in 
accordance with good agricultural practices under the conditions of the 
2-year experimental program. This includes all anticipated dietary 
exposures and all other exposures for which there is reliable 
information. The Agency has arrived at this conclusion based on the 
data submitted previously and summarized in the RED, as well as that 
data submitted to support the temporary tolerance exemption and 
Experimental Use Permit applications, demonstrating negligible dietary 
exposure in comparison with the toxicity NOAELs. As a result, EPA 
establishes a temporary exemption from the tolerance requirements 
pursuant to FFDCA 408(c) and (d) for residues of 6-benzyladenine in or 
on apples and pistachios.

IX. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA, EPA will continue to use those procedures, with 
appropriate adjustments, until the necessary modifications can be made. 
The new section 408(g) of the FFDCA provides essentially the same 
process for persons to ``object'' to a regulation for an exemption from 
the requirement of a tolerance issued by EPA under new section 408(d), 
as was provided in the old sections 408 and 409 of the FFDCA. However, 
the period for filing objections is now 60 days, rather than 30 days.

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

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2002-0308 in the subject line on the 
first page of your submission. All

[[Page 5838]]

requests must be in writing, and must be mailed or delivered to the 
Hearing Clerk on or before April 7, 2003.
    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 (1900C), 
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 Rm.104, Crystal Mall 2, 1921 
Jefferson Davis Hwy., Arlington, VA. 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 
(703) 603-0061.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    3. 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 Unit I.B.1. Mail 
your copies, identified by docket ID number OPP-2002-0308, 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 Unit I.B.1. 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).

X. References

    1. U.S. EPA, Reregistration Eligibility Decision (RED) N6-
Benzyladenine, June 1994.
    2. U.S. EPA; Memorandum; R. S. Jones to D. Greenway; October 2, 
2002.
    3. Weigand, R., et al, Metabolism and Movement of N-[Phenylmethyl]-
1H-Purin-6-Amine in Soils, 1976. Unpublished study received January 13, 
1977 for EPA Registration Number 275-32; submitted by Abbott 
Laboratories, North Chicago, IL; CDL:095728-C.
    4. Nandi, S. K., et al, Identification of cytokinins in primary 
crown gall tumours of tomato, Plant Cell and Environment (1989) 12:273-
283.
    5. Pechova, D., et al, Identification of new aromatic cytokinins in 
plants, 17th International Conference on Plant Growth Substances, July 
1-6, 2001.
    6. Strnad, M., et al, Immunodectection and identification of 
N6-(o-hydroxybenzylamino) purine as a naturally occurring 
cytokinin in Populus x canadensis Moench cv Robusta leaves, Plant 
Physiol. (1992) 99:74-80.
    7. Strnad, M., Enzyme immunoassays of N6-benzyladenine 
and N6-(meta-hydroxybenzyl)adenine cytokinins, J Plant 
Growth Regul. (1996) 15:179-188.
    8. Van Staden, J. and N. R. Crouch, Benzyladenine and derivatives-
their significance and interconversion in plants, Plant Growth 
Regulation (1996) 19:153-175.

XI. Statuatory and Executive Order Review

    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

[[Page 5839]]

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.

XII. Submission to Congress and the Comptroller General

    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: January 16, 2003.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

    Authority: 21 U.S.C. 321(q), 346(a) and 374.

    2. Section 180.1150 of subpart D is revised to read as follows:


Sec.  180.1150  6-Benzyladenine; exemption from the requirement of a 
tolerance.

    (a) The plant growth regulator 6-benzyladenine is exempt from the 
requirement of a tolerance when used as a fruit-thinning agent at an 
application rate not to exceed 30 grams of active ingredient per acre 
in or on apples.
    (b) 6-Benzyladenine is temporarily exempt from the requirement of a 
tolerance in or on apples at <=182 grams of active ingredient per acre 
per season, and in or on pistachio at <=60 grams of active ingredient 
per acre per season when used in accordance with the Experimental Use 
Permit 73049-EUP-2. The temporary exemption from a tolerance will 
expire on January 31, 2005.
[FR Doc. 03-2431 Filed 2-4-03; 8:45 am]
BILLING CODE 6560-50-S