[Federal Register Volume 69, Number 64 (Friday, April 2, 2004)]
[Rules and Regulations]
[Pages 17304-17308]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-7475]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0013; FRL-7347-6]


6-Benzyladenine; Exemption from the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of the biochemical pesticide, 6-
benzyladenine (6-BA), in or on pistachio, and amends the existing 
exemption for apple to expand the uses and increase the application 
rate. 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 an exemption 
from the requirement of a tolerance. This regulation eliminates the 
need to establish a maximum permissible level for residues of 6-BA.

DATES: This regulation is effective April 2, 2004. Objections and 
requests for hearings, identified by docket ID number OPP-2004-0013, 
must be received on or before June 1, 2004.

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 IX. 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:
     Crop production (NAICS 111)
     Animal production (NAICS 112)
     Food manufacturing (NAICS 311)
     Pesticide manufacturing (NAICS 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 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-2004-0013. 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 E-CFR Beta Site 
Two at http://www.gpoaccess.gov/ecfr.
    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. Once in the system, select ``search,'' 
then key in the appropriate docket ID number.

[[Page 17305]]

II. Background and Statutory Findings

    In the Federal Register of July 30, 2003 (68 FR 44777) (FRL-7315-
7), 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 (PP 3F6586) 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 180.1150 be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of 6-BA in or on pistachio, and by amending the existing 
exemption under Sec.  180.1150 for apple to expand the uses and 
increase the application rate.
    Previously, temporary exemptions from the requirement of a 
tolerance, set to expire on January 31, 2005, were established by EPA 
for residues of 6-BA in or on apple and pistachio (February 5, 2003, 68 
FR 5835) (FRL-7287-2) for the same uses as proposed above, when applied 
in accordance with the Experimental Use Permit (73049-EUP-2) issued on 
January 22, 2003 (February 26, 2003, 68 FR 8900) (FRL-7293-4).
    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) 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. 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 factor set forth in 
section 408(b)(2)(C), which require 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-BA 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 (http://www.epa.gov/oppsrrd1/REDs/old_reds/n6benzyladenine.pdf.) 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 (lethal dose (LD)50 = 1.3 
grams/kilogram (g/kg)), and in the eye irritation study in the rabbit 
(moderate irritant). Toxicity Category IV (the least toxic category) 
was assigned to the acute dermal toxicity study in the rabbit 
(LD50 >5 g/kg), the acute inhalation toxicity study in the 
rat (lethal concentration (LC)50 = 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 6-BA is not a dermal sensitizer. 
There have been no reported incidents of hypersensitivity directly 
linked to 6-BA. Nevertheless, to comply with the Agency's requirement 
under FIFRA section 6(a)(2), any incident of hypersensitivity 
associated with the use of this pesticide must be reported to the 
Agency.
    2. Genotoxicity. From three mutagenicity studies (Ames test, mouse 
micronucleus assay, and unscheduled DNA synthesis assay in the rat), it 
was determined that 6-BA 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 milligrams/kilogram body weight/day (mg/kg bwt/day), 
respectively. Based on these results and the Agency's assessment of 
dietary risk (see Units IV. and VI.) there is a reasonable certainty 
that no harm will be associated with this proposed pesticide use of 6-
BA.
    4. Subchronic toxicity. For rats of both sexes, the NOAEL was 
approximately 111 mg/kg bwt/day and the LOAEL was approximately 304 mg/
kg bwt/day. Based on these results and the Agency's assessment of 
dietary risk (see Units IV. and VI.) there is a reasonable certainty 
that no harm will be associated with the proposed pesticide use of 6-
BA.

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 yielded acceptable 
magnitude of the residue data. 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-BA 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 tolerance exemption, limited by maximum application rates 
<=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-BA residues 
relative to the chronic and acute population adjusted doses (see Unit 
VII.), 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-BA 
on apple and pistachio will result in adverse effects to human health.
    2. Drinking water exposure. The proposed uses on apple and 
pistachio are not expected to add potential

[[Page 17306]]

exposure to drinking water. Soil leaching studies have suggested that 
6-BA is relatively immobile, 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, 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-BA residues for the 
general population, including infants and children, is unlikely because 
the uses are limited to applications in apple and pistachio orchards. 
Because 6-BA is a naturally occurring cytokinin plant regulator, it is 
a normal part of the human diet. The proposed use rates are well below 
the toxicity NOAELs (see Unit III.). 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-BA, 
any increased exposure due to the proposed uses would be negligible due 
to the lack of residue in comparison with the toxicity NOAELs.

V. Cumulative Effects

    Section 408(b)(2)(D)(v) of 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.'' These considerations include the 
possible cumulative effects of such residues on infants and children.
    EPA does not have, at this time, available data to suggest whether 
6-BA has a common mechanism of toxicity with other substances. 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 6-BA and any other substances and 
6-BA does not appear to produce a toxic metabolite produced by other 
substances. For the purposes of this tolerance action, therefore, EPA 
has not assumed that 6-BA has a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see the policy statements 
released by EPA's Office of Pesticide Programs concerning common 
mechanism determinations and procedures for cumulating effects from 
substances found to have a common mechanism on EPA's web site at http://www.epa.gov/pesticides/cumulative/.

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-BA 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 
reasonably certain that the proposed new uses of 6-BA on apple and 
pistachio will not result in adverse effects to human health.
    2. Infants and children. FFDCA section 408(b)(2)(C) provides that 
EPA shall apply an additional ten-fold margin of exposure (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 determines that a different margin of exposure (safety) will 
be safe for infants and children. Margins of exposure (safety) are 
often referred to as uncertainty (safety) factors. Here, 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-BA 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 reasonably certain that the proposed 
new uses of 6-BA on apple and pistachio will not result in adverse 
effects to human health.
    Accordingly, the Agency believes the data indicate there are no 
threshold effects of concern to infants, children, and adults when 6-BA 
is used as labeled, and that the provision requiring an additional 
margin of safety is not necessary to protect infants and children. As a 
result, EPA has not used a margin of exposure (safety) approach to 
assess the safety of 6-BA.

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-BA 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-BA. To date, there is no evidence to suggest that 6-BA affects the 
immune system, functions in a manner similar to any known hormone, or 
that it acts as an endocrine disruptor.

B. Analytical Method(s)

    The Agency is establishing an 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

[[Page 17307]]

for 6-BA. Nonetheless, analytical methods for apple raw agricultural 
and processed commodities, and pistachio, have been developed, and 
submitted by the registrant.

C. Codex Maximum Residue Level

    Currently, there are no Codex, Canadian or Mexican maximum residue 
levels for residues of 6-BA in/on apple or pistachio.

VIII. Conclusions

    Based on the toxicology information submitted and reviewed 
previously, and summarized in the June 1994 N6-Benzyladenine RED, there 
is a reasonable certainty that no harm will result from aggregate 
exposure of residues of 6-BA 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. 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 this 
tolerance exemption, demonstrating negligible dietary exposure in 
comparison with the toxicity NOAELs. As a result, EPA establishes an 
exemption (albeit, limited by maximum application rates) from the 
tolerance requirements pursuant to FFDCA 408(c) and (d) for residues of 
6-BA in or on apple and pistachio.

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) 
of the FFDCA, 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-2004-0013 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 June 1, 
2004.
    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 IX.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-2004-0013, 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. Statutory and Executive Order Reviews

    This final rule establishes an exemption from the tolerance

[[Page 17308]]

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.

XI. 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: March 23, 2004.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention 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 180.1150 is amended by revising paragraph (a) to read as 
follows:


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

    (a) The biochemical plant regulator 6-benzyladenine (6-BA) is 
exempt from the requirement of a tolerance in or on apple at an 
application rate of <=182 grams of active ingredient per acre per 
season, and in or on pistachio at an application rate of <=60 grams of 
active ingredient per acre per season.
    (b) * * *

[FR Doc. 04-7475 Filed 4-1-04; 8:45 am]
BILLING CODE 6560-50-S