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Hydramethylnon. August 4, 2004. Tolerances increased and terminology revision. Federal Register.


Note from FAN.
Due to the length of this Notice we have only included the parts that cite Hydramethylnon.

http://www.epa.gov/fedrgstr/EPA-PEST/2004/August/Day-04/p17508.htm

[Federal Register: August 4, 2004 (Volume 69, Number 149)]
[Proposed Rules]
[Page 47051-47068]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04au04-28]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2004-0154; FRL-7368-7]

Bromoxynil, Diclofop-methyl, Dicofol, Diquat, Etridiazole, et
al.; Proposed Tolerance Actions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing to revoke certain tolerances for the
herbicides bromoxynil, diclofop-methyl, and paraquat; the fungicides
etridiazole (terrazole) and iprodione; the miticides dicofol and
propargite; and the plant growth regulator and herbicide diquat. Also,
EPA is proposing to remove duplicate tolerances for the herbicides
bromoxynil and picloram; the fumigant phosphine; the fungicide
iprodione; the miticides dicofol and propargite; and the insecticides
fenbutatin-oxide and hydramethylnon. In addition, EPA is proposing to
modify certain tolerances for the insecticide hydramethylnon; the
herbicides bromoxynil, paraquat, and triclopyr; the fungicides
etridiazole, folpet, iprodione, and triphenyltin hydroxide (TPTH); the
miticides dicofol and propargite; and the plant growth regulator and
herbicide diquat. Moreover, EPA is proposing to establish new
tolerances for the herbicides bromoxynil, paraquat, and picloram; the
fungicides etridiazole, folpet, and TPTH; the miticides dicofol and
propargite; the insecticide fenbutatin-oxide; and the plant growth
regulator and herbicide diquat. The regulatory actions proposed in this
document are part of the Agency's reregistration program under the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and the
tolerance reassessment requirements of the Federal Food, Drug, and
Cosmetic Act (FFDCA) section 408(q), as amended by the Food Quality
Protection Act (FQPA) of 1996. By law, EPA is required by August 2006
to reassess the tolerances in existence on August 2, 1996. No tolerance
reassessments will be counted at the time of a final rule because
tolerances in existence at FQPA that are associated with actions
proposed herein were previously counted as reassessed at the time of
the completed Registration Eligibility Decision (RED), Report on FQPA
Tolerance Reassessment Progress and Interim Risk Management Decision
(TRED), or Federal Register action.
DATES: Comments must be received on or before October 4, 2004.
ADDRESSES: Submit your comments, identified by docket ID number OPP-
2004-0154
, by one of the following methods:
• Federal eRulemaking Portal: http://www.regulations.gov/.
Follow the on-line instructions for submitting comments.
• Agency Website: http://www.epa.gov/edocket/. EDOCKET,
EPA's electronic public docket and comment system, is EPA's preferred
method for receiving comments. Follow
[[Page 47052]]
the on-line instructions for submitting comments.
• E-mail: Comments may be sent by e-mail to
opp-docket@epa.gov, Attention: Docket ID Number OPP-2004-0154.
• Mail: Public Information and Records Integrity Branch
(PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001, Attention: Docket ID Number OPP-2004-0154.
• Hand Delivery: Public Information and Records Integrity
Branch (PIRIB), Office of Pesticide Programs (OPP), Environmental
Protection Agency, Rm. 119, Crystal Mall #2, 1801 South Bell
St., Arlington, VA, Attention: Docket ID Number OPP-2004-0154. Such
deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
Instructions: Direct your comments to docket ID number OPP-2004-
0154. EPA's policy is that all comments received will be included in
the public docket without change and may be made available online at
http://www.epa.gov/edocket/, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through EDOCKET,
regulations.gov, or e-mail. The EPA EDOCKET and the regulations.gov
websites are ``anonymous access'' systems, which means EPA will not
know your identity or contact information unless you provide it in the
body of your comment. If you send an e-mail comment directly to EPA
without going through EDOCKET or regulations.gov, your e-mail address
will be automatically captured and included as part of the comment that
is placed in the public docket and made available on the Internet. If
you submit an electronic comment, EPA recommends that you include your
name and other contact information in the body of your comment and with
any disk or CD ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional information about EPA's public
docket visit EDOCKET on-line or see the Federal Register of May 31,
2002 (67 FR 38102) (FRL-7181-7).
Docket: All documents in the docket are listed in the EDOCKET index
at http://www.epa.gov/edocket/. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in EDOCKET or in hard
copy at the Public Information and Records Integrity Branch (PIRIB),
Rm. 119, Crystal Mall #2, 1801 South Bell St., Arlington, VA.
This Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays. The Docket telephone number is (703)
305-5805.
FOR FURTHER INFORMATION CONTACT: Joseph Nevola, Special Review and
Reregistration Division (7508C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave, NW.,
Washington, DC 20460-0001; telephone number: (703) 308-8037; e-mail
address:nevola.joseph@epa.gov.
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. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in Unit IIA. If you have
any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Access Electronic Copies of This Document and Other
Related Information?
In addition to using EDOCKET (http://www.epa.gov/edocket/), you may
access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at http://www.epa.gov/
fedrgstr/. A frequently updated electronic version of 40 CFR part 180
is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/
ecfr/.
C. What Should I Consider as I Prepare My Comments for EPA?
Submitting CBI. Do not submit this information to EPA through
EDOCKET, regulations.gov, or e-mail. Clearly mark the part or all of
the information that you claim to be CBI. For CBI information in a disk
or CD ROM that you mail to EPA, mark the outside of the disk or CD ROM
as CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed as CBI). In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the rulemaking by docket number and other identifying
information (subject heading, Federal Register date, and page number).
ii. Follow directions. The agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns, and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
[[Page 47053]]
D. What Can I do if I Wish the Agency to Maintain a Tolerance That the
Agency Proposes to Revoke?
This proposed rule provides a comment period of 60 days for any
person to state an interest in retaining a tolerance proposed for
revocation. If EPA receives a comment within the 60-day period to that
effect, EPA will not proceed to revoke the tolerance immediately.
However, EPA will take steps to ensure the submission of any needed
supporting data and will issue an order in the Federal Register under
FFDCA section 408(f) if needed. The order would specify data needed and
the time frames for its submission, and would require that within 90
days some person or persons notify EPA that they will submit the data.
If the data are not submitted as required in the order, EPA will take
appropriate action under FFDCA.
EPA issues a final rule after considering comments that are
submitted in response to this proposed rule. In addition to submitting
comments in response to this proposal, you may also submit an objection
at the time of the final rule. If you fail to file an objection to the
final rule within the time period specified, you will have waived the
right to raise any issues resolved in the final rule. After the
specified time, issues resolved in the final rule cannot be raised
again in any subsequent proceedings.
II. Background
A. What Action is the Agency Taking?
EPA is proposing to revoke, remove, modify, and establish specific
tolerances for residues of the insecticides fenbutatin-oxide and
hydramethylnon, the herbicides bromoxynil, diclofop-methyl, paraquat,
picloram, and triclopyr; the fumigant phosphine; the fungicides
etridiazole, folpet, iprodione, and triphenyltin hydroxide (TPTH); the
miticides dicofol and propargite, and the plant growth regulator and
herbicide diquat in or on commodities listed in the regulatory text.
EPA is proposing these tolerance actions to implement the tolerance
recommendations made during the reregistration and tolerance
reassessment processes (including follow-up on canceled or additional
uses of pesticides). As part of the reregistration and tolerance
reassessment processes, EPA is required to determine whether each of
the amended tolerances meets the safety standards under the FQPA. The
safety finding determination of ``reasonable certainty of no harm'' is
found in detail in each RED and Report on FQPA Tolerance Reassessment
Progress and Interim Risk Management Decision (TRED) for the active
ingredient. REDs and TREDs propose certain tolerance actions to be
implemented to reflect current use patterns, to meet safety findings
and change commodity names and groupings in accordance with new EPA
policy. Printed copies of the REDs and TREDs may be obtained from EPA's
National Service Center for Environmental Publications (EPA/NSCEP),
P.O. Box 42419, Cincinnati, OH 45242-2419, telephone 1-800-490-9198;
fax 1-513-489-8695; internet at http://www.epa.gov/ncepihom/ and from
the National Technical Information Service (NTIS), 5285 Port Royal
Road, Springfield, VA 22161, telephone 1-800-553-6847 or 703-605-6000;
internet at http://www.ntis.gov/ Electronic copies of REDs and TREDs
are available on the internet at http://www.epa.gov/pesticides/
reregistration/status.htm.
Explanations for proposed modifications in tolerances can be found
in the RED and TRED document and in more detail in the Residue
Chemistry Chapter document which supports the RED and TRED. Copies of
the Residue Chemistry Chapter documents are found in the Administrative
Record and hard copies are available in the public docket for this
rule, while electronic copies are available through EPA's electronic
public docket and comment system, EPA Dockets at http://www.epa.gov/
edocket/. You may search for docket number OPP-2004-0154 then
click on that docket number to view its contents.

EPA has determined that the aggregate acute exposure and risk and
the aggregate chronic exposure and risk are not of concern for the
above mentioned pesticide active ingredients based upon the target data
base required for reregistration, the current guidelines for conducting
acceptable studies to generate such data, published scientific
literature, and the data identified in the RED or TRED which lists the
submitted studies that the Agency found acceptable.
With respect to the tolerances that are proposed in this document
to be raised, EPA has found that these tolerances are safe in
accordance with FFDCA section 408(b)(2)(A), and that there is a
reasonable certainty that no harm will result to infants and children
from aggregate exposure to the pesticide chemical residues, in
accordance with section 408(b)(2)(C). These findings are found in
detail in each RED
. The references are available for inspection as
described in this document under SUPPLEMENTARY INFORMATION.
In addition, EPA is proposing to revoke certain tolerances because
these pesticides are not registered under FIFRA for uses on the
commodities. The registrations for these pesticide chemicals were
canceled because the registrant failed to pay the required maintenance
fee and/or the registrant voluntarily canceled one or more registered
uses of the pesticide. It is EPA's general practice to propose
revocation of those tolerances for residues of pesticide active
ingredients on crop uses for which there are no active registrations
under FIFRA, unless any person in comments on the proposal indicates a
need for the tolerance to cover residues in or on imported commodities
or domestic commodities legally treated.

[[Page 47054]]
[[Page 47055]]
[[Page 47056]]
[[Page 47057]]
[[Page 47058]]

8. Hydramethylnon (pyrimidinone). EPA is proposing to increase the
tolerance in 40 CFR 180.395(a) on ``grass (pasture and rangeland)''
from 0.05 to 2.0 ppm and revise the terminology to ``grass, forage''
and ``grass, hay;'' based on available field trial data which show
residues of hydramethylnon above the current tolerance level and label
amendments which reflect parameters of use patterns for which field
trials are available; i.e., reflect a zero day post harvest interval
since that the Agency no longer allows a PHI restriction on grass. The
tolerance for ``grass hay (pasture and rangeland)'' was recommended to
be increased from 0.05 to 0.1 ppm, based on available field trial data
previously discussed and label amendments which reflect a zero day post
harvest interval. However, because the terminology should be revised to
``grass, hay,'' that tolerance at 0.1 ppm is no longer needed since it
would be a duplicate covered by the proposed tolerance at 2.0 ppm.
Therefore, EPA is proposing to remove the tolerance in 40 CFR
180.395(a) for grass hay (pasture and rangeland).
Since the hydramethylnon RED was completed in 1998, a tolerance was
established in 40 CFR 180.395(a) for ``pineapple'' (68 FR 48302, August
13, 2003)(FRL-7319-5).


[[Page 47060]]
[[Page 47061]]

B. What is the Agency's Authority for Taking This Action?
A ``tolerance'' represents the maximum level for residues of
pesticide chemicals legally allowed in or on raw agricultural
commodities and processed foods. Section 408 of FFDCA, 21 U.S.C. 301 et
seq., as amended by the FQPA of 1996, Public Law 104-170, authorizes
the establishment of tolerances, exemptions from tolerance
requirements, modifications in tolerances, and revocation of tolerances
for residues of pesticide chemicals in or on raw agricultural
commodities and processed foods (21 U.S.C. 346(a)). Without a tolerance
or exemption, food containing pesticide residues is considered to be
unsafe and therefore ``adulterated'' under section 402(a) of the FFDCA.
Such food may not be distributed in interstate commerce (21 U.S.C.
331(a) and 342(a)). For a food-use pesticide to be sold and
distributed, the pesticide must not only have appropriate tolerances
under the FFDCA, but also must be registered under FIFRA (7 U.S.C. et
seq.). Food-use pesticides not registered in the United States must
have tolerances in order for commodities treated with those pesticides
to be imported into the United States.
EPA is proposing these tolerance actions to implement the tolerance
recommendations made during the RED and TRED processes, and as follow-
up on canceled uses of pesticides. As part of the RED and TRED
processes, EPA is required to determine whether each of the amended
tolerances meets the safety standards under the FQPA. The safety
finding determination is found in detail in each Post-FQPA RED and TRED
for the active ingredient. REDs and TREDs propose certain tolerance
actions to be implemented to reflect current use patterns, to meet
safety findings, and change commodity names and groupings in accordance
with new EPA policy. Printed and electronic copies of the REDs and
TREDs are available as provided in Unit II.A.
EPA has issued Post-FQPA REDs for Bromoxynil, Diclofop-methyl,
Dicofol, Etridiazole, Folpet, Hydramethylnon, Iprodione, Paraquat,
Phosphine, Propargite, Triclopyr, and Triphenyltin hydroxide, and TREDs
for Diquat and Fenbutatin-oxide, whose REDs were both completed prior
to FQPA. EPA also issued a RED prior to FQPA for Picloram and in 1999
made a safety finding which reassessed its tolerances according to the
FQPA standard, maintaining them when new tolerances were established as
noted in Unit II.A. REDs and TREDs contain the Agency's evaluation of
the data base for these pesticides, including requirements for
additional data on the active ingredients to confirm the potential
human health and environmental risk assessments associated with current
product uses, and in REDs contain the Agency's decisions and conditions
under which these uses and products will be eligible for
reregistration. The REDs and TREDs recommended the establishment,
modification, and/or revocation of specific tolerances. RED and TRED
recommendations such as establishing or modifying tolerances, require
assessment under the FQPA standard of ``reasonable certainty of no
harm,'' and are proposed in those documents under that standard.
However, tolerance revocations recommended in REDs and TREDs may be
proposed in this document without such assessment when the tolerances
are no longer necessary.
EPA's general practice is to propose revocation of tolerances for
residues of pesticide active ingredients on crops for which FIFRA
registrations no longer exist and on which the pesticide may therefore
no longer be used in the United States. EPA has historically been
concerned that retention of tolerances that are not necessary to cover
residues in or on legally treated foods may encourage misuse of
pesticides within the United States. Nonetheless, EPA will establish
and maintain tolerances even when corresponding domestic uses are
canceled if the tolerances, which EPA refers to as ``import
tolerances,'' are necessary to allow importation into the United States
of food containing such pesticide residues. However, where there are no
imported commodities that require these import tolerances, the Agency
believes it is appropriate to revoke tolerances for unregistered
pesticides in order to prevent potential misuse.
Furthermore, as a general matter, the Agency believes that
retention of import tolerances not needed to cover any imported food
may result in unnecessary restriction on trade of pesticides and foods.
Under section 408 of the FFDCA, a tolerance may only be established or
maintained if EPA determines that the tolerance is safe based on a
number of factors, including an assessment of the aggregate exposure to
the pesticide and an assessment of the cumulative effects of such
pesticide and other substances that have a common mechanism of
toxicity. In doing so, EPA must consider potential contributions to
such exposure from all tolerances. If the cumulative risk is such that
the tolerances in aggregate are not safe, then every one of these
tolerances is potentially vulnerable to revocation. Furthermore, if
unneeded tolerances are included in the aggregate and cumulative risk
assessments, the estimated exposure to the pesticide would be inflated.
Consequently, it may be more difficult for others to obtain needed
tolerances or to register needed new uses. To avoid potential trade
restrictions, the Agency is proposing to revoke tolerances for residues
on crops for which FIFRA registrations no longer exist, unless someone
expresses a need for such tolerances. Through this proposed rule, the
Agency is inviting individuals who need these import
[[Page 47063]]
tolerances to identify themselves and the tolerances that are needed to
cover imported commodities.
Parties interested in retention of the tolerances should be aware
that additional data may be needed to support retention. These parties
should be aware that, under FFDCA section 408(f), if the Agency
determines that additional information is reasonably required to
support the continuation of a tolerance, EPA may require that parties
interested in maintaining the tolerances provide the necessary
information. If the requisite information is not submitted, EPA may
issue an order revoking the tolerance at issue.
C. When Do These Actions Become Effective?
EPA is proposing that revocations, modifications, establishments of
tolerances, and commodity terminology revisions become effective 90
days following publication of a final rule in the Federal Register to
ensure that all affected parties receive notice of EPA's actions. For
this rule, the proposed revocations will affect tolerances for uses
which have been canceled, in some cases, for many years. The Agency
believes that existing stocks of pesticide products labeled for the
uses associated with the tolerances proposed for revocation have been
completely exhausted and that treated commodities have had sufficient
time for passage through the channels of trade. However, if EPA is
presented with information that existing stocks would still be
available and that information is verified, the Agency will consider
extending the expiration date of the tolerance. If you have comments
regarding existing stocks and whether the effective date allows
sufficient time for treated commodities to clear the channels of trade,
please submit comments as described under SUPPLEMENTARY INFORMATION.
Any commodities listed in this proposal treated with the pesticides
subject to this proposal, and in the channels of trade following the
tolerance revocations, shall be subject to FFDCA section 408(1)(5), as
established by FQPA. Under this section, any residues of these
pesticides in or on such food shall not render the food adulterated so
long as it is shown to the satisfaction of the Food and Drug
Administration that:
1. The residue is present as the result of an application or use of
the pesticide at a time and in a manner that was lawful under FIFRA.
2. The residue does not exceed the level that was authorized at the
time of the application or use to be present on the food under a
tolerance or exemption from tolerance. Evidence to show that food was
lawfully treated may include records that verify the dates that the
pesticide was applied to such food.

D. What Is the Contribution to Tolerance Reassessment?
By law, EPA is required by August 2006 to reassess the tolerances
in existence on August 2, 1996. As of July 26, 2004, EPA has reassessed
over 6,740 tolerances. Regarding tolerances mentioned in this proposed
rule, tolerances in existence at FQPA were previously counted as
reassessed at the time of the signature completion of a Post-FQPA RED
or TRED for each active ingredient, except for picloram whose
tolerances were counted as reassessed via final rulemaking which
published in the Federal Register on January 5, 1999 (64 FR 418), as
described in Units II.A. and B. Therefore, no further tolerance
reassessments would be counted toward the August 2006 review.
III. Are the Proposed Actions Consistent With International
Obligations?
The tolerance revocations in this proposal are not discriminatory
and are designed to ensure that both domestically-produced and imported
foods meet the food safety standards established by the FFDCA. The same
food safety standards apply to domestically produced and imported
foods.
EPA is working to ensure that the U.S. tolerance reassessment
program under FQPA does not disrupt international trade. EPA considers
Codex Maximum Residue Limits (MRLs) in setting U.S. tolerances and in
reassessing them. MRLs are established by the Codex Committee on
Pesticide Residues, a committee within the Codex Alimentarius
Commission, an international organization formed to promote the
coordination of international food standards. It is EPA's policy to
harmonize U.S. tolerances with Codex MRLs to the extent possible,
provided that the MRLs achieve the level of protection required under
FFDCA. EPA's effort to harmonize with Codex MRLs is summarized in the
tolerance reassessment section of individual Reregistration Eligibility
Decision documents. EPA has developed guidance concerning submissions
for import tolerance support (65 FR 35069, June 1, 2000) (FRL-6559-3).
This guidance will be made available to interested persons. Electronic
copies are available on the internet at http://www.epa.gov/. On the
Home Page select ``Laws, Regulations, and Dockets,'' then select
``Regulations and Proposed Rules'' and then look up the entry for this
document under ``Federal Register--Environmental Documents.'' You can
also go directly to the ``Federal Register'' listings at
http://www.epa.gov/fedrgstr/.

IV. Statutory and Executive Order Reviews
In this proposed rule, EPA is proposing to establish specific
tolerances under FFDCA section 408(e), and to modify and revoke
specific tolerances established under FFDCA section 408. The Office of
Management and Budget (OMB) has exempted these types of actions (i.e.,
establishment and modification of a tolerance and tolerance revocation
for which extraordinary circumstances do not exist) from review under
Executive Order 12866, entitled Regulatory Planning and Review (58 FR
51735, October 4, 1993). Because this proposed rule has been exempted
from review under Executive Order 12866 due to its lack of
significance, this proposed 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 proposed
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 as required by 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 other 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). Pursuant to the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency previously
assessed whether establishment of tolerances, exemptions from
tolerances, raising of tolerance levels, expansion of exemptions, or
revocations of tolerances might significantly impact a substantial
[[Page 47064]]
number of small entities and concluded that, as a general matter, these
actions do not impose a significant economic impact on a substantial
number of small entities. These analyses for tolerance establishments
and modifications, and for tolerance revocations were published on May
4, 1981 (46 FR 24950) and on December 17, 1997 (62 FR 66020),
respectively, and were provided to the Chief Counsel for Advocacy of
the Small Business Administration. Taking into account this analysis,
and available information concerning the pesticides listed in this
rule, the Agency hereby certifies that this proposed action will not
have a significant negative economic impact on a substantial number of
small entities. Specifically, as per the 1997 notice, EPA has reviewed
its available data on imports and foreign pesticide usage and concludes
that there is a reasonable international supply of food not treated
with canceled pesticides. Furthermore, for the pesticides named in this
proposed rule, the Agency knows of no extraordinary circumstances that
exist as to the present proposal that would change the EPA's previous
analysis. Any comments about the Agency's determination should be
submitted to the EPA along with comments on the proposal, and will be
addressed prior to issuing a final rule. 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
proposed 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
proposed rule does not have any ``tribal implications'' as described in
Executive Order 13175, entitled Consultation and Coordination with
Indian Tribal Governments (59 FR 22951, 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 proposed 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 proposed rule.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: July 19, 2004.
James Jones,
Director, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR part 180 be amended as
follows:
PART 180--[AMENDED]

* * * * *

14. Section 180.395 is amended by revising the table in paragraph
(a) to read as follows:
Sec. 180.395 Hydramethylnon; tolerances for residues.
* * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Grass, forage.............................................. 2.0
Grass, hay................................................. 2.0
Pineapple.................................................. 0.05
------------------------------------------------------------------------



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[FR Doc. 04-17508 Filed 8-3-04; 8:45 am]
BILLING CODE 6560-50-S