Lindane; Proposed Tolerance Actions, 20036-20041 [05-7410]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 70, Number 72 (Friday, April 15, 2005)]
[Proposed Rules]
[Pages 20036-20041]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-7410]



[[Page 20035]]

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

Part IV





Environmental Protection Agency





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



40 CFR Part 180



Lindane; Proposed Tolerance Actions; Notice of Availability; Proposed 
Rule and Notice

Federal Register / Vol. 70, No. 72 / Friday, April 15, 2005 / 
Proposed Rules

[[Page 20036]]


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

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.

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

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: https://www.regulations.gov/. 
Follow the on-line instructions for submitting comments.
     Agency Web site: https://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 
https://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 https://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 (https://www.epa.gov/edocket/), you may 
access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at https://www.epa.gov/
fedrgstr/. A frequently updated electronic version of 40 CFR part 180 
is available at E-CFR Beta Site Two at https://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 https://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 https://www.ntis.gov/. Electronic copies of REDs and TREDs 
are available on the internet at https://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 https://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

[[Page 20038]]

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

[[Page 20039]]

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 https://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 https://
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]]



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