Lindane; Proposed Tolerance Actions;
Notice of Availability; Proposed
Rule and Notice
[Federal Register: April 15, 2005 (Volume 70, Number 72)]
[Proposed Rules]
[Page 20035-20041]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15ap05-13]
[[Page 20035]]
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Part IV
Environmental Protection Agency
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40 CFR Part 180
Lindane; Proposed Tolerance Actions; Notice of Availability; Proposed
Rule and Notice
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2004-0246; FRL-7702-2]
Lindane; Proposed Tolerance Actions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing to revoke specific existing tolerances for
the insecticide lindane because, following receipt of registrant
requests, the Agency canceled their associated Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) registrations.
DATES: Comments must be received on or before June 14, 2005.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number OPP-2004-0246, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov/.
Follow the on-line instructions for submitting comments.
Agency Web site: http://www.epa.gov/edocket/. EDOCKET,
EPA's electronic public docket and comment system, is EPA's preferred
method for receiving comments. Follow 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-2004-0246.
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-2004-0246.
Hand Delivery: Public Information and Records Integrity
Branch (PIRIB), Office of Pesticide Programs (OPP), Environmental
Protection Agency, Rm. 119, Crystal Mall 2, 1801 S. Bell St.,
Arlington, VA, Attention: Docket ID number OPP-2004-0246. 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-
0246. EPA's policy is that all comments received will be included in
the public docket without change and may be made available on-line 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 S. Bell St., Arlington, VA. This
Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays. The Docket telephone number is (703)
305-5805.
FOR FURTHER INFORMATION CONTACT: 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 II.A. 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?
1. 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
[[Page 20037]]
accordance with procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the rulemaking by docket ID 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.
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 specific existing tolerances for
residues of the insecticide lindane 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
Food Quality Protection Act (FQPA). The safety finding determination of
``reasonable certainty of no harm'' is found in detail in each
Reregistration Eligibility Decision (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.
Additional information can be found in the Lindane RED and the
Residue Chemistry Chapter document which supports the RED. A copy of
the lindane Residue Chemistry Chapter is found in the Administrative
Record and a hard copy is available in the public docket OPP-2002-0202,
while an electronic copy is 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-2002-0202, then click on that
docket number to view the Lindane RED support documents.
EPA is proposing to revoke certain specific existing tolerances for
lindane because there are no longer any active registrations under
FIFRA for uses on their associated commodities. 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 submitted on
the proposal, indicates a need for the tolerance to cover residues in
or on imported commodities or domestic commodities legally treated.
EPA published notices in the Federal Register under section 6(f)(1)
of FIFRA announcing its receipt of requests from registrants to cancel
or amend certain product registrations and delete certain lindane uses.
Except for some seed treatment registrations, all other food use
registrations for the insecticide lindane were canceled because EPA
accepted the registrants' requests for voluntary cancellation.
In the Federal Register notice of September 30, 1998 (63 FR 52257)
(FRL-6028-6), EPA announced the receipt of requests for amendments to
delete specific uses, mushroom and nectarine, from certain lindane
registrations. The Agency made the use deletions effective on March 29,
1999, and registrant sale and distribution of existing stocks was
permitted for a period of 18 months; i.e., until September 29, 2000.
EPA believes that end users have had sufficient time, more than four
years, to exhaust those existing stocks and for treated commodities to
have cleared the channels of trade. Therefore, the Agency is proposing
to revoke the associated tolerances in 40 CFR 180.133 for mushroom and
nectarine to be effective on the date of publication of the final rule
in the Federal Register.
In the Federal Register notice of January 27, 1999 (64 FR 4096)
(FRL-6035-1), EPA announced the receipt of requests for amendments to
delete specific uses, apricot, asparagus, avocado, eggplant, grape,
guava, mango, pear, pecans, pepper, pineapple, quince, strawberry, and
tomato, from certain lindane registrations. The Agency made the use
deletions effective on July 26, 1999, and registrant sale and
distribution of existing stocks was permitted for a period of 18
months; i.e., until January 26, 2001. EPA believes that end users have
had sufficient time, more than four years, to exhaust those existing
stocks and for treated commodities to have cleared the channels of
trade. Therefore, the Agency is proposing to revoke the associated
tolerances in 40 CFR 180.133 for
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apricot, asparagus, avocado, eggplant, grape, guava, mango, pear,
pecans, pepper, pineapple, quince, strawberry, and tomato to be
effective on the date of publication of the final rule in the Federal
Register.
In the Federal Register notice of September 1, 1999 (64 FR 47786)
(FRL-6098-9), EPA announced the receipt of requests to voluntarily
cancel certain lindane registrations, two of which included plums among
their effected commodity uses. The Agency made the registration
cancellations effective on March 22, 2000, and registrant sale and
distribution of existing stocks was permitted for one year after the
cancellation requests were received by the Agency; i.e., until June 9,
2000. EPA believes that end users have had sufficient time, more than
four years, to exhaust those existing stocks and for treated
commodities to have cleared the channels of trade. Therefore, the
Agency is proposing to revoke the associated tolerances in 40 CFR
180.133 for plum; and plum, prune, fresh; to be effective on the date
of publication of the final rule in the Federal Register.
In the Federal Register notice of November 3, 1999 (64 FR 59763)
(FRL-6383-9), EPA announced the receipt of requests to voluntarily
cancel certain lindane registrations, two of which included apples,
cherries, and peaches among their effected commodity uses. The Agency
made the registration cancellations effective on May 9, 2000, and
registrant sale and distribution of existing stocks was permitted for
one year after the cancellation requests were received by the Agency;
i.e., until August 18, 2000. EPA believes that end users have had
sufficient time, more than four years, to exhaust those existing stocks
and for treated commodities to have cleared the channels of trade.
Therefore, the Agency is proposing to revoke the associated tolerances
in 40 CFR 180.133 for apple, cherry, and peach to be effective on the
date of publication of the final rule in the Federal Register.
In the Federal Register notice of August 28, 2002 (67 FR 55241)
(FRL-7196-1), EPA announced the receipt of requests for amendments to
delete specific uses, including spinach, from certain lindane
registrations with an effective date of September 27, 2002. However, in
a previous Federal Register notice of June 13, 2002 (67 FR 40730) (FRL-
7178-4), EPA's receipt of requests for amendments to delete uses,
including spinach, celery, collards, kale, kohlrabi, lettuce, mustard
greens, and Swiss chard from a certain lindane technical registration
was announced and made effective on December 10, 2002, and registrant
sale and distribution of existing stocks was permitted for a period of
18 months; i.e., until June 10, 2004. Here, EPA is proposing to revoke
the associated tolerances in 40 CFR 180.133 for celery, collards, kale,
kohlrabi, lettuce, mustard greens, spinach, and Swiss chard with an
expiration/revocation date of June 10, 2005. The Agency believes that
end users will have sufficient time to exhaust existing stocks and for
treated commodities to have cleared the channels of trade.
In the Federal Register notice of January 26, 2005 (70 FR 3704)
(FRL-7698-2), EPA announced receipt of a request for an amendment to
delete specific lindane uses from one registration, including seed
treatment uses for broccoli, Brussels sprouts, cabbage, and
cauliflower. The Agency made the use deletions effective on February
25, 2005. However, registrant sale and distribution of existing stocks
was permitted for a period of 18 months after the October 26, 2004
approval of the revision; i.e., until April 26, 2006. The Agency
believes that end users will have sufficient time to exhaust existing
stocks and for treated commodities to have cleared the channels of
trade by April 26, 2007. Therefore, EPA is proposing to revoke the
associated tolerances in 40 CFR 180.133 for broccoli, Brussels sprouts,
cabbage, and cauliflower with an expiration/revocation date of April
26, 2007.
The Federal Register notice of August 15, 2002 (67 FR 53350) (FRL-
7192-3) corrected the effective date found in the notice of July 17,
2002 (67 FR 46976) (FRL-7186-4), which announced EPA's receipt of
requests for amendments to delete specific uses, including cucumbers,
cantaloupe, watermelon, okra, onions, pumpkins, and squash, from
certain lindane registrations. The Agency corrected the use deletions
to be effective on August 17, 2002, and registrant sale and
distribution of existing stocks was permitted for a period of 18
months; i.e., until February 17, 2004. The Agency believes that end
users will have sufficient time to exhaust existing stocks and for
treated commodities to have cleared the channels of trade also by June
10, 2005. Therefore, EPA is proposing to revoke the associated
tolerances in 40 CFR 180.133 for cucumber, melon, okra, onion (dry
bulb), pumpkin, squash, and squash, summer with an expiration/
revocation date of June 10, 2005.
There are lindane end-use active registrations for seed treatments
on cereal grains which are eligible for reregistration, provided that
mitigation measures specified in the lindane RED are implemented and
the Agency can establish tolerances for the seed treatment uses of
lindane. The establishment of seed treatment tolerances is conditioned
on EPA's ability to make a determination that establishing the new
tolerances meets the safety standard in FFDCA.
Currently, it is possible that livestock feed may be derived from
grain grown from lindane-treated seed and residues of lindane in
livestock would be expected. Consequently, the Agency believes that the
existing livestock fat tolerances for lindane per se must be maintained
until and unless the grain seed treatment uses are no longer
registered. If the Agency is unable to make a safety finding that would
support the establishment of tolerances on wheat, barley, oats, rye,
corn, and sorghum for lindane residues resulting from seed treatment
only, it will take steps to cancel the grain seed treatment
registrations and propose revocation of the livestock fat tolerances.
The Agency intends to complete its assessment of the seed treatment
uses on or prior to August 3, 2006.
Because some tolerances will remain codified in 40 CFR 180.133 with
expiration/revocation dates, EPA is proposing to amend the residue
definition for lindane in order to harmonize with the International
Union of Pure and Applied Chemistry nomenclature. Currently the
tolerances are established in 40 CFR 180.133 and expressed in terms of
residues of lindane per se (gamma isomer of benzene hexachloride). EPA
is proposing to amend the lindane nomenclature to gamma isomer of
1,2,3,4,5,6-hexachlorocyclohexane.
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 (RACs), 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 RACs, 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)). Food-
use pesticides not registered in the United States must have tolerances
in order for
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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 a Post-FQPA RED for lindane. 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 the Agency's decisions and
conditions under which these uses and products will be eligible for
reregistration. In addition, REDs and TREDs recommend 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 uses 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
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?
With the exception of certain tolerances for which EPA is proposing
specific expiration/revocation dates, the Agency is proposing that
revocation of other tolerances become effective on the date of
publication of the final rule in the Federal Register because their
associated uses have been canceled, in some cases, for several years.
The Agency believes that existing stocks of pesticide products labeled
for the uses associated with these other tolerances, proposed for
revocation at the time of the final rule, 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, and (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.
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
Pestcide Residues, a committee within the Codex Alimentarius
Commission, an international organization formed to promote the
coordination of
[[Page 20040]]
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 of June 1, 2000 (65 FR 35069) (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 revoke specific
tolerances established under FFDCA section 408. The Office of
Management and Budget (OMB) has exempted this type of action (i.e.,
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 revocations of
tolerances might significantly impact a substantial 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. This analysis was published on December 17, 1997 (62 FR
66020), and was 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 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 pesticide 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 (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 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: April 1, 2005.
James Jones,
Director, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR chapter I be amended as
follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In Sec. 180.133 in paragraph (a) is revised to read as follows:
Sec. 180.133 Lindane; tolerances for residues.
(a) General. Tolerances are established for residues of the
insecticide lindane (gamma isomer of 1,2,3,4,5,6-hexachlorocyclohexane)
in or on raw agriculture commodities as follows:
[[Page 20041]]
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Expiration/Revocation
Commodity Parts per million Date
----------------------------------------------------------------------------------------------------------------
Broccoli...................................................... 1.0 4/26/07
Brussels sprouts.............................................. 1.0 4/26/07
Cabbage....................................................... 1.0 4/26/07
Cattle, fat................................................... 7.0 None
Cauliflower................................................... 1.0 4/26/07
Celery........................................................ 1.0 6/10/05
Collards...................................................... 1.0 6/10/05
Cucumber...................................................... 3.0 6/10/05
Goat, fat..................................................... 7.0 None
Hog, fat...................................................... 4.0 None
Horse, fat.................................................... 7.0 None
Kale.......................................................... 1.0 6/10/05
Kohlrabi...................................................... 1.0 6/10/05
Lettuce....................................................... 3.0 6/10/05
Melon......................................................... 3.0 6/10/05
Mustard greens................................................ 1.0 6/10/05
Okra.......................................................... 1.0 6/10/05
Onion, dry bulb............................................... 1.0 6/10/05
Pumpkin....................................................... 3.0 6/10/05
Sheep, fat.................................................... 7.0 None
Spinach....................................................... 1.0 6/10/05
Squash........................................................ 3.0 6/10/05
Squash, summer................................................ 3.0 6/10/05
Swiss chard................................................... 1.0 6/10/05
----------------------------------------------------------------------------------------------------------------
* * * * *
[FR Doc. 05-7410 Filed 4-12-05; 3:38 pm]
BILLING CODE 6560-50-S
Full Text Version of this Document
http://www.thefederalregister.com/d.p/2005-04-15-05-7410