[Federal Register Volume 70, Number 182 (Wednesday, September 21, 2005)]
[Rules and Regulations]
[Pages 55282-55286]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-18829]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0246; FRL-7734-3]


Lindane; Tolerance Actions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: EPA is revoking 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 in the United States.

DATES: This regulation is effective September 21, 2005. However, 
certain regulatory actions will not occur until the date specified in 
the regulatory text. Objections and requests for hearings must be 
received on or before November 21, 2005.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit IV. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under Docket 
identification (ID) number OPP-2004-0246. 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: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111), e.g., agricultural 
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers 
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 32532), e.g., 
agricultural workers; commercial applicators; farmers; greenhouse, 
nursery, and floriculture workers; residential users.
    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 underFOR FURTHER INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document and Other 
RelatedInformation?

    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 athttp://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/.

II. Background

A. What Action is the Agency Taking?

    In the Federal Register of April 15, 2005 (70 FR 20035) (FRL-7702-
2), EPA proposed to revoke certain tolerances for residues of the 
insecticide lindane. Also, the proposal of April 15, 2005, provided a 
60-day comment period which invited public comment for consideration 
and for support of tolerance retention under the Federal Food, Drug, 
and Cosmetic Act (FFDCA) standards.
    The tolerances revoked in this final rule are no longer necessary 
to cover residues of the relevant pesticide in or on domestically 
treated commodities or commodities treated outside but imported into 
the United States. It is EPA's general practice to revoke those 
tolerances and tolerance exemptions 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 or tolerance exemption to cover residues in or 
on imported commodities or domestic commodities legally treated.
    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. Thus, it 
is EPA's policy to issue a final rule revoking those tolerances for 
residues of pesticide chemicals for which there are no active 
registrations under FIFRA, unless any person commenting on the proposal 
demonstrates a need for the tolerance to cover residues in or on 
imported commodities or domestic commodities legally treated.
    Generally, EPA will proceed with the revocation of these tolerances 
on the grounds discussed in Unit II.A. if one of the following 
conditions applies:
    1. Prior to EPA's issuance of a section 408(f) order requesting 
additional data or issuance of a section 408(d) or (e) order revoking 
the tolerances on other grounds, commenters retract the comment 
identifying a need for the tolerance to be retained.
    2. EPA independently verifies that the tolerance is no longer 
needed.
    3. The tolerance is not supported by data that demonstrate that the 
tolerance meets the requirements under FQPA.
    Today's final rule does not revoke those tolerances for which EPA 
received comments stating a need for the tolerance to be retained. In 
response to the proposal published in the Federal Register of April 15, 
2005 (70 FR 20035), EPA received comments during the 60-day public 
comment period, as follows:
    Comments by private citizens. One private citizen stated that all 
lindane tolerances should be revoked. Another private citizen expressed 
a general

[[Page 55283]]

concern about the use of lindane as a pharmaceutical product.
    Comment by the Washington Toxics Coalition (WTC). The WTC supports 
EPA's action to revoke remaining crop tolerances for lindane. The WTC 
stated that it had earlier submitted, along with the Pesticide Action 
Network North America (PANNA) and Alaska Community Action on Toxics 
(ACAT), a petition dated March 31, 2005, to EPA which requested the 
revocation of all tolerances for lindane. The WTC stated its opposition 
to the continued use of lindane as a pharmaceutical product and 
registration of lindane for seed treatment. The WTC expressed a concern 
for lindane pesticide risks to farmworkers, children, mothers, 
indigenous people, and animals.
    Comment by Technology Sciences Group Incorporated (TSG). On behalf 
of its client, Crompton Corporation (currently known as Chemtura) who 
is a registrant of lindane seed treatment products, TSG agreed with 
revocation of lindane tolerances associated with canceled lindane uses 
and retention of livestock fat tolerances to accommodate lindane seed 
treatment uses. TSG disagreed with the petition by PANNA, et. al., and 
stated that revocation of the livestock fat tolerances would be 
counterproductive because of the existing seed treatment uses.
    Agency response. None of the commenters took issue with the 
Agency's proposal to revoke certain lindane tolerances which were no 
longer needed or whose associated food uses were no longer current or 
registered in the United States. To the extent that commenters raise 
issues relevant to the establishment of tolerances for the seed 
treatment uses, EPA will consider those comments during assessment of 
seed treatment tolerances, which will be completed by August 2006.
    It is EPA's general practice to revoke 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.
    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 July 31, 2002, Lindane 
Registration Eligibility Decision (RED) are implemented and the Agency 
can establish tolerances for the seed treatment uses of lindane. These 
mitigation measures include the following actions: prohibition of dust 
formulations on certain crops, reduction of maximum application rates, 
addition of personal protective equipment requirements, and the 
establishment of a 24-hour restricted re-entry interval. 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.
    The proposal of April 15, 2005, did not address the pharmaceutical 
use of lindane. Lindane is an ectoparasiticide and ovicide. The U.S. 
Food and Drug Administration (FDA) has the primary responsibility for 
regulating human ectoparasite pharmaceutical treatments. Information 
regarding such use is available through the FDA's Center for Drug's 
Division of Drug Information at http://www.fda.gov/cder/Offices/DDI/default.htm.
    Therefore, EPA is implementing 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 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 RED and Residue Chemistry Chapter are found in the 
Administrative Record and hard copies are 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 ID number OPP-
2002-0202, then click on that docket ID number to view the Lindane RED 
support documents.
    EPA is revoking certain specific existing tolerances for lindane 
because there are no longer any active registrations under FIFRA for 
uses on their associated commodities. 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.
    EPA made amendments to delete mushroom and nectarine uses from 
lindane registrations 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 4 years, to exhaust those existing 
stocks and for treated commodities to have cleared the channels of 
trade. Therefore, the Agency is revoking the tolerances in 40 CFR 
180.133 for residues of the insecticide lindane in or on mushroom and 
nectarine.
    EPA made amendments to delete apricot, asparagus, avocado, 
eggplant, grape, guava, mango, pear, pecans, pepper, pineapple, quince, 
strawberry, and tomato uses from lindane registrations 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 4 
years, to exhaust those existing stocks

[[Page 55284]]

and for treated commodities to have cleared the channels of trade. 
Therefore, the Agency is revoking the tolerances in 40 CFR 180.133 for 
residues of the insecticide lindane in or on apricot, asparagus, 
avocado, eggplant, grape, guava, mango, pear, pecans, pepper, 
pineapple, quince, strawberry, and tomato.
    EPA made registration cancellations, which included plums among 
their affected commodity uses, effective on March 22, 2000, and 
registrant sale and distribution of existing stocks was permitted for 
1-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 5 years, to exhaust those existing stocks 
and for treated commodities to have cleared the channels of trade. 
Therefore, the Agency is revoking the tolerances in 40 CFR 180.133 for 
residues of the insecticide lindane in or on plum and plum, prune, 
fresh.
    EPA made registration cancellations, which included apples, 
cherries, and peaches among their affected commodity uses, effective on 
May 9, 2000, and registrant sale and distribution of existing stocks 
was permitted for 1-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 5 years, to exhaust those existing 
stocks and for treated commodities to have cleared the channels of 
trade. Therefore, the Agency is revoking the tolerances in 40 CFR 
180.133 for residues of the insecticide lindane in or on apple, cherry, 
and peach.
    EPA made amendments to delete spinach, celery, collards, kale, 
kohlrabi, lettuce, mustard greens, and Swiss chard uses from a lindane 
registration 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. EPA believes that end users have had 
sufficient time to exhaust existing stocks and for treated commodities 
to have cleared the channels of trade. Because the proposed expiration/
revocation dates of June 10, 2005, are now past, EPA is revoking the 
tolerances in 40 CFR 180.133 for residues of the insecticide lindane in 
or on celery, collards, kale, kohlrabi, lettuce, mustard greens, 
spinach, and Swiss chard, all effective on the date of publication of 
this final rule in the Federal Register.
    EPA made amendments to delete seed treatment uses for broccoli, 
Brussels sprouts, cabbage, and cauliflower from a lindane registration 
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 revoking the 
tolerances in 40 CFR 180.133 for residues of the insecticide lindane in 
or on broccoli, Brussels sprouts, cabbage, and cauliflower with 
expiration/revocation dates of April 26, 2007.
    EPA made amendments to delete cucumber, cantaloupe, watermelon, 
okra, onions, pumpkin, and squash uses from lindane registrations 
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. EPA believes that end users have had sufficient time 
to exhaust existing stocks and for treated commodities to have cleared 
the channels of trade. Because the proposed expiration/revocation dates 
of June 10, 2005, are now past, EPA is revoking the tolerances in 40 
CFR 180.133 for residues of the insecticide lindane in or on cucumber, 
melon, okra, onion (dry bulb), pumpkin, squash, and squash, summer, all 
effective on the date of publication of this final rule in the Federal 
Register.
    Because some tolerances will remain codified in 40 CFR 180.133 with 
expiration/revocation dates, a revision of the residue definition for 
lindane is needed in order to harmonize with the International Union of 
Pure and Applied Chemistry (IUPAC) nomenclature. Therefore, EPA is 
amending the tolerance expression in 40 CFR 180.133 from residues of 
lindane (gamma isomer of benzene hexachloride) to lindane (gamma isomer 
of 1,2,3,4,5,6-hexachlorocyclohexane).

B. What is the Agency's Authority for Taking this Action?

    EPA's general practice is to revoke 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.

C. When Do These Actions Become Effective?

    With the exception of certain lindane tolerances which EPA is 
revoking with specific expiration/revocation dates, the actions in this 
final rule become effective on the date of publication of this final 
rule in the Federal Register because the specific lindane tolerances 
revoked herein are no longer needed or are associated with food uses 
that have been canceled for several years. The Agency believes that 
treated commodities have had sufficient time for passage through the 
channels of trade.
    Any commodities listed in the regulatory text of this document that 
are treated with the pesticides subject to this final rule, and that 
are in the channels of trade following the tolerance revocations, shall 
be subject to FFDCA section 408(1)(5), as established by the 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 There Any International Trade Issues Raised by this Final 
Action?

    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. When possible, EPA seeks 
to harmonize U.S. tolerances with Codex MRLs. EPA may

[[Page 55285]]

establish a tolerance that is different from a Codex MRL; however, 
FFDCA section 408(b)(4) requires that EPA explain in a Federal Register 
document the reasons for departing from the Codex level. EPA's effort 
to harmonize with Codex MRLs is summarized in the tolerance 
reassessment section of individual REDs. 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 and Regulations,'' 
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. Objections and Hearing Requests

    Under section 408(g) of FFDCA, as amended by 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 FFDCA by FQPA, EPA 
will continue to use those procedures, with appropriate adjustments, 
until the necessary modifications can be made. The new section 408(g) 
of 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 FFDCA, as was 
provided in the old sections 408 and 409 of 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-2004-0246 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 November 
21, 2005.
    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 (1900L), 
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 Suite 350, 1099 14\th\ St., NW., 
Washington, DC 20005. 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 (202) 564-6255.
    2. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit IV.A.1., 
you should also send a copy of your request to the PIRIB for its 
inclusion in the official record that is described in ADDRESSES. Mail 
your copies, identified by docket ID number OPP-2004-0246, 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 ADDRESSES. You may also send an electronic copy of 
your request via e-mail to: [email protected]. Please use an ASCII 
file format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

V. Statutory and Executive Order Reviews

    In this final rule EPA is revoking specific tolerances established 
under FFDCA section 408. The Office of Management and Budget (OMB) has 
exempted this type of action (i.e., a 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 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 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 104-13, 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

[[Page 55286]]

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 final rule 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 pesticides named in this final rule, the Agency knows of no 
extraordinary circumstances that exist as to the present revocations 
that would change EPA's previous analysis. 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 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.

VI. 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: September 12, 2005
James Jones,
Director, Office of Pesticide Programs.

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

PART 180--AMENDED

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

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

0
2. In section 180.133, 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 agricultural commodities as follows:

------------------------------------------------------------------------
                                                             Expiration/
                   Commodity                     Parts per    Revocation
                                                  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
Goat, fat.....................................          7.0         None
Hog, fat......................................          4.0         None
Horse, fat....................................          7.0         None
Sheep, fat....................................          7.0         None
------------------------------------------------------------------------

* * * * *

[FR Doc. 05-18829 Filed 9-20-05; 8:45 am]
BILLING CODE 6560-50-S