[Federal Register Volume 69, Number 47 (Wednesday, March 10, 2004)]
[Rules and Regulations]
[Pages 11317-11322]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-4985]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0028; FRL-7345-3]


Pyriproxyfen; Pesticide Tolerance for Emergency Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited tolerance for 
residues of pyriproxyfen in or on celery. This action is in response to 
EPA's granting of an emergency exemption under section 18 of the 
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing 
use of the pesticide on celery. This regulation establishes a maximum 
permissible level for residues of pyriproxyfen in this food commodity. 
The tolerance will expire and is revoked on June 30, 2007.

DATES: This regulation is effective March 10, 2004. Objections and 
requests for hearings, identified by docket ID number OPP-2004-0028, 
must be received on or before May 10, 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 VII. of the SUPPLEMENTARY 
INFORMATION.

FOR FURTHER INFORMATION CONTACT: Libby Pemberton, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9364; 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 producers (NAICS 111)
     Animal producers (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-2004-0028. 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

    EPA, on its own initiative, in accordance with sections 408(e) and 
408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 
U.S.C. 346a, is establishing a tolerance for residues of the 
insecticide pyriproxyfen, 2-[1-methyl-2(4-phenoxyphenoxy) 
ethoxypyridine], in or on celery at 2.5 parts per million (ppm). This 
tolerance will expire and is revoked on June 30, 2007. EPA will publish 
a document in the Federal Register to remove the revoked tolerance from 
the Code of Federal Regulations.
    Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under section 18 
of FIFRA. Such tolerances can be established without providing notice 
or period for public comment. EPA does not intend for its actions on 
section 18 related tolerances to set binding precedents for the 
application of section 408 of the FFDCA and the new safety standard to 
other tolerances and exemptions. Section 408(e) of the FFDCA allows EPA 
to establish a tolerance or an exemption from the requirement of a 
tolerance on its own initiative, i.e., without having received any 
petition from an outside party.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish 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

[[Page 11318]]

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. . . .''
    Section 18 of the FIFRA authorizes EPA to exempt any Federal or 
State agency from any provision of FIFRA, if EPA determines that 
``emergency conditions exist which require such exemption.'' This 
provision was not amended by the Food Quality Protection Act of 1996 
(FQPA). EPA has established regulations governing such emergency 
exemptions in 40 CFR part 166.

III. Emergency Exemption for Pyriproxyfen on Celery and FFDCA 
Tolerances

    None of the currently registered alternatives were effective in 
controlling the severe greenhouse whitefly (Trialeurodes vaporariorum) 
and silverleaf whitefly (Bemisia argentifolii) infestations that 
occurred on California celery 2001-02 where some fields experienced a 
100% loss. The state estimates that California celery growers, without 
pyriproxyfen, would lose $1,493 per acre for the coming season. For the 
affected 11,000 acres this would represent a loss of $16,423,000. EPA 
has authorized under FIFRA section 18 the use of pyriproxyfen on celery 
for control of greenhouse whitefly (Trialeurodes vaporariorum) and 
silverleaf whitefly (Bemisia argentifolii) in California. After having 
reviewed the submission, EPA concurs that emergency conditions exist 
for this State.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of pyriproxyfen in or on 
celery. In doing so, EPA considered the safety standard in section 
408(b)(2) of the FFDCA, and EPA decided that the necessary tolerance 
under section 408(l)(6) of the FFDCA would be consistent with the 
safety standard and with FIFRA section 18. Consistent with the need to 
move quickly on the emergency exemption in order to address an urgent 
non-routine situation and to ensure that the resulting food is safe and 
lawful, EPA is issuing this tolerance without notice and opportunity 
for public comment as provided in section 408(l)(6) of the FFDCA. 
Although this tolerance will expire and is revoked on June 30, 2007, 
under section 408(l)(5) of the FFDCA, residues of the pesticide not in 
excess of the amounts specified in the tolerance remaining in or on 
celery after that date will not be unlawful, provided the pesticide is 
applied in a manner that was lawful under FIFRA, and the residues do 
not exceed a level that was authorized by this tolerance at the time of 
that application. EPA will take action to revoke this tolerance earlier 
if any experience with, scientific data on, or other relevant 
information on this pesticide indicate that the residues are not safe.
    Because this tolerance is being approved under emergency 
conditions, EPA has not made any decisions about whether pyriproxyfen 
meets EPA's registration requirements for use on celery or whether a 
permanent tolerance for this use would be appropriate. Under these 
circumstances, EPA does not believe that this tolerance serves as a 
basis for registration of pyriproxyfen by a State for special local 
needs under FIFRA section 24(c). Nor does this tolerance serve as the 
basis for any State other than California to use this pesticide on this 
crop under section 18 of FIFRA without following all provisions of 
EPA's regulations implementing FIFRA section 18 as identified in 40 CFR 
part 166. For additional information regarding the emergency exemption 
for pyriproxyfen, contact the Agency's Registration Division at the 
address provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of the FFDCA and a complete 
description of the risk assessment process, see the final rule on 
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).
    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. EPA has sufficient data to assess the hazards of 
pyriproxyfen and to make a determination on aggregate exposure, 
consistent with section 408(b)(2) of the FFDCA, for a time-limited 
tolerance for residues of pyriproxyfen in or on celery at 2.5 ppm. 
EPA's assessment of the dietary exposures and risks associated with 
establishing the tolerance follows.

A. Toxicological Endpoints

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies 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 no observed adverse effect level (NOAEL) and the lowest 
observed adverse effect level (LOAEL) from the toxicity studies 
reviewed as well as the nature of the toxic effects caused by 
pyriproxyfen are discussed in Unit III.A. of the Federal Registers of 
June 5, 2001 (66 FR 30065) (FRL-6782-5), August 28, 2002 (67 FR 55150) 
(FRL-7195-7), and March 7, 2003 (68 FR 10972) (FRL-7289-6).
    Refer to the March 7, 2003, Federal Register document for a 
detailed discussion of the aggregate risk assessments and determination 
of safety. EPA relies upon that risk assessment and the findings made 
in the Federal Register document in support of this action. Below is a 
brief summary of the aggregate risk assessment, including this use on 
celery.

B. Exposure Assessment

    EPA assessed risk scenarios for pyriproxyfen under chronic and 
intermediate and short-term (residential) scenarios. Because there were 
no acute endpoints identified, an acute risk assessment was not 
conducted. Nor was a cancer aggregate risk assessment conducted, 
because pyriproxyfen is classified as ``not likely'' to be a human 
carcinogen.
    The Dietary Exposure Evaluation Model (DEEM\TM\) analysis evaluated 
the individual food consumption as reported by respondents in the 
Department of Agricultural (USDA) 1994-1996 and 1998 nationwide 
Continuing Surveys of Food Intake by Individuals (CSFII) and 
accumulated exposure to the chemical for each commodity.
    The following assumptions were made for the chronic exposure 
assessments: Published and proposed tolerance level residues and 100% 
crop treated were assumed for all commodities, and the default 
processing factors were applied.
    Using these exposure assumptions, EPA concluded that pyriproxyfen 
chronic exposures from food consumption are below levels of concern (< 
100% of the chronic Population Adjusted Dose (cPAD)) for the general 
U.S. population and all population subgroups. The cPAD utilized for the 
most highly exposed subgroup (children 1-2 years old) is 4%. Chronic 
risk from dietary exposure for infants (< 1 year old) and children (6-
12 years old) each utilize 2.0% of the cPAD. Chronic dietary risk for 
the general U.S. population is 1.0% of the cPAD. In addition, despite 
the potential for chronic dietary exposure to

[[Page 11319]]

pyriproxyfen in drinking water, after calculating drinking water levels 
of concern (DWLOCs) and comparing them to conservative model estimated 
environmental concerns (EEC) of pyriproxyfen in surface and ground 
waters, EPA does not expect the aggregate exposure to exceed 100% of 
the cPAD, as shown in the following table:

              Table 1.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Pyriproxyfen
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                                                               Aggregate
                                                  Aggregate     Level of     Surface       Ground     Short-Term
              Population Subgroup                MOE (Food +    Concern     Water EEC    Water EEC   DWLOC (ppb)
                                                Residential)     (LOC)        (ppb)        (ppb)
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General U. S. Population......................         8,816          100          0.4        0.006       12,000
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All infants <1 year...........................         1,029          100          0.4        0.006        3,400
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Children 1-2 years............................           853          100          0.4        0.006        3,400
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Children 3-5 years............................           936          100          0.4        0.006        3,400
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Females 13-49 years old.......................        12,390          100          0.4        0.006       10,000
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    Short-term and intermediate-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). The term ``residential 
exposure'' is used in this document to refer to non-occupational, non-
dietary exposure (e.g., for lawn and garden pest control, indoor pest 
control, termiticides, flea and tick control on pets).
    Pyriproxyfen is currently registered for various residential non-
dietary sites, and is used for flea and tick control (home environment 
and pet treatments) as well as products for ant and roach control. Pet 
owners could potentially be exposed to pyriproxyfen during applications 
to pets; however, since no short-term dermal or inhalation endpoints 
were identified, only a post-application residential assessment was 
conducted. Both adults and toddlers could potentially be exposed to 
pyriproxyfen residues on treated carpets, floors, upholstery, and pets, 
but it is anticipated that toddlers will have higher exposures than 
adults due to behavior patterns. Therefore, the residential risk 
assessment addressed post-application exposures of toddlers, which is 
considered to be a worst-case scenario. Short-term, intermediate-term, 
and long-term toddler hand-to-mouth exposures (consisting of petting 
treated animals and touching treated carpets/flooring) were assessed; 
long-term dermal exposures were also assessed for products with 
anticipated efficacy of more than 6 months (carpet powders and pet 
collars). Toddler exposures to combined treatment scenarios, where a 
pet owner treats the home environment and the pet in the same period 
were also assessed.
    The Agency has determined that it is appropriate to aggregate 
chronic food and water, and short-term or intermediate-term exposures 
for pyriproxyfen. Using the exposure assumptions described above for 
short-term and intermediate-term exposures, EPA has concluded that food 
and residential exposures aggregated result in aggregate MOEs as shown 
in the following tables:

                   Table 2.--Aggregate Risk Assessment for Short-Term Exposure to Pyriproxyfen
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                                                               Aggregate
                                                  Aggregate     Level of     Surface       Ground     Short-Term
              Population Subgroup                MOE (Food +    Concern     Water EEC    Water EEC   DWLOC (ppb)
                                                Residential)     (LOC)        (ppb)        (ppb)
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All infants (<1 year).........................         2,900          100          0.4        0.006        9,400
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Children 1-2 years............................         2,900          100          0.4        0.006        9,400
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Children 3-5 years............................           600          100          0.4        0.006        9,400
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               Table 3.--Aggregate Risk Assessment for Intermediate-Term Exposure to Pyriproxyfen
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                                                             Aggregate
                                                Aggregate     Level of     Surface       Ground    Intermediate-
             Population Subgroup               MOE (Food +    Concern     Water EEC    Water EEC     Term DWLOC
                                              Residential)     (LOC)        (ppb)        (ppb)         (ppb)
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All infants (<1 year).......................           650          100          0.4        0.006         3,000
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Children 1-2 years..........................           576          100          0.4        0.006         2,900
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Children 3-5 years..........................           613          100          0.4        0.006         2,900
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[[Page 11320]]

    These aggregate MOEs do not exceed the Agency's level of concern 
for aggregate exposure to food and residential uses. For surface and 
ground water, the EECs for pyriproxyfen are significantly less than the 
DWLOCs as a contribution to intermediate-term and short-term aggregate 
exposure. Therefore, EPA concludes with reasonable certainty that 
residues of pyriproxyfen in drinking water do not contribute 
significantly to the intermediate-term or short-term aggregate human 
health risk at the present time.
    Pyriproxyfen is classified as not likely to be a human carcinogen, 
so the Agency did not conduct a cancer aggregate risk assessment.
    Based upon these risk assessments, EPA concludes that there is a 
reasonable certainty that no harm will result to the general 
population, and to infants and children, from aggregate exposure to 
pyriproxyfen residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas liquid chromotography with 
nitrogen-phosphorus (GLC/NP) detector) is available to enforce the 
tolerance expression. The method may be requested from: Chief, 
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes 
Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail 
address: [email protected].

B. International Residue Limits

    There are no Codex, Canadian, or Mexican maximum residue limits for 
residues of pyriproxyfen in/on celery, so international harmonization 
is not an issue.

C. Conditions

    A maximum of three applications may be made, at a maximum rate of 
0.067 lbs active ingredient (a.i.) per acre per season, using ground or 
air application equipment. Do not exceed 0.20 lbs a.i. per acre per 
year. A 14 day pre-harvest interval must be observed.

VI. Conclusion

    Therefore, the tolerance is established for residues of 
pyriproxyfen, 2-[1-methyl-2(4-phenoxyphenoxy) ethoxypyridine, in or on 
celery at 2.50 ppm.

VII. 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-2004-0028 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 May 10, 
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 VII.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 the docket ID number OPP-2004-0028, 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.

[[Page 11321]]

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).

VIII. Statutory and Executive Order Reviews

    This final rule establishes a time-limited tolerance under section 
408 of the FFDCA. 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 FIFRA 
section 18 exemption under section 408 of the FFDCA, such as the 
tolerance 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.

IX. 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: February 24, 2004.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

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

PART 180--[AMENDED]

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

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


0
2. Section 180.510 is amended by alphabetically adding ``celery'' to 
the table in paragraph (b) to read as follows:


Sec.  180.510  Pyriproxyfen; tolerances for residues.

* * * * *
    (b) * * *

------------------------------------------------------------------------
                                                          Expiration/
             Commodity              Parts per million   revocation date
------------------------------------------------------------------------
                                * * * * *
Celery............................               2.50            6/30/07
                                * * * * *
------------------------------------------------------------------------


[[Page 11322]]

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[FR Doc. 04-4985 Filed 3-9-04; 8:45 am]
BILLING CODE 6560-50-S