[Federal Register Volume 69, Number 188 (Wednesday, September 29, 2004)]
[Rules and Regulations]
[Pages 58079-58083]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-21695]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0260; FRL-7679-7]


Allethrin, Bendiocarb, Burkholderia cepacia, Fenridazon 
potassium, and Molinate; Tolerance Actions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is revoking all tolerances for residues of the 
insecticides allethrin and bendiocarb, plant growth regulator 
fenridazon potassium, herbicide molinate, and biological pesticide 
Burkholderia cepacia because EPA canceled food registrations or deleted 
food uses from registrations following requests for voluntary 
cancellation or use deletion by the registrants. The regulatory actions 
in this document contribute toward the Agency's tolerance reassessment 
requirements of the Federal Food, Drug, and Cosmetic Act (FFDCA) 
section 408(q), as amended by the Food Quality Protection Act (FQPA) of 
1996. By law, EPA is required by August 2006, to reassess the 
tolerances in existence on August 2, 1996. The regulatory actions in 
this document pertain to the revocation of 110 tolerances and tolerance 
exemptions of which 106 count as tolerance reassessments toward the 
August 2006 review deadline.

DATES: This regulation is effective September 29, 2004. 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 29, 2004.

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-2004-0260. 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., 
Confidential Business Information (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 111), e.g., agricultural workers; 
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and 
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 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 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/.

II. Background

A. What Action is the Agency Taking?

    In the Federal Register of July 7, 2004 (69 FR 40831) (FRL-7362-2), 
EPA issued a proposed rule to revoke certain tolerances and tolerance 
exemptions for residues of the insecticides allethrin and bendiocarb, 
plant growth regulator fenridazon potassium, herbicide molinate, and 
biological pesticide Burkholderia cepacia. Also, the July 7, 2004 
proposal 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.
    In this final rule, EPA is revoking certain tolerances and 
tolerance exemptions for residues of the insecticides allethrin and 
bendiocarb, plant growth regulator fenridazon potassium, herbicide 
molinate, and the biological pesticide Burkholderia cepacia because 
these specific tolerances and exemptions correspond to uses no longer 
current or registered under FIFRA in the United States. The tolerances 
revoked by this final rule are no longer necessary to cover residues of 
the relevant pesticides 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 expressed a concern that retention of 
tolerances that

[[Page 58080]]

are not necessary to cover residues in or on legally treated foods has 
the potential to 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 July 7, 
2004 (69 FR 40831), EPA received one comment during the 60-day comment 
period, as follows:
    Comment. EPA received a comment from the California Rice Commission 
(CRC), who expressed support for EPA's decision to revoke the 
tolerances for residues of molinate in or on rice grain and rice straw, 
each with an expiration date of September 1, 2009. Also, the CRC 
expressed support for the molinate 5-year phase out and stated that the 
phase out allows rice growers a phase in period for newer pesticides 
while the registrants work with EPA in bringing replacement products to 
market. The CRC described itself as a statutory organization 
representing 2,500 rice growers who farm approximately 500,000 acres of 
California farmland.
    Agency response. EPA appreciates the support of the CRC on the 
phase out of molinate, which has been a tool for California rice 
growers in controlling pests. The phase out and tolerance revocations 
for molinate are discussed in detail elsewhere in this document.
    1. Allethrin. Many food use registrations for allethrin were 
canceled in 1989 and 1991 due to non-payment of maintenance fees. After 
reviewing labels for allethrin stereoisomer active ingredients 
(bioallethrin, 004003; s-bioallethrin, 004004; and d-cis-trans-
allethrin, 004005), EPA has determined that their current active 
registered uses are not associated with any of the existing tolerances 
in 40 CFR 180.113 or tolerance exemptions in 40 CFR 180.1002 for 
allethrin (004001). The allethrin stereoisomers are primarily used as 
flying insect killers and repellents.
    EPA defines the tolerances and exemptions in 40 CFR 180.113 and 
180.1002 as pertaining solely to allethrin (004001) as the active 
ingredient. This is the earliest form of the allethrin stereoisomers, 
and may be referred to as a racemic mixture. Because there are no 
active registrations for use of allethrin (004001) on commodities 
associated with these tolerances or tolerance exemptions, these 
tolerances and tolerance exemptions are no longer needed. Therefore, 
EPA is revoking the 30 tolerances in 40 CFR 180.113 for residues of 
allethrin in or on apple, postharvest; barley, grain, postharvest; 
blackberry, postharvest; blueberry, postharvest; boysenberry, 
postharvest; cherry, postharvest; corn, grain, postharvest; crabapple, 
postharvest; currant, postharvest; dewberry, postharvest; fig, 
postharvest; gooseberry, postharvest; grape, postharvest; guava, 
postharvest; huckleberry, postharvest; loganberry, postharvest; mango, 
postharvest; muskmelon, postharvest; oat, grain, postharvest; orange, 
postharvest; peach, postharvest; pear, postharvest; pineapple, 
postharvest; plum, postharvest; plum, prune, fresh, postharvest; 
raspberry, postharvest; rye, grain, postharvest; sorghum, grain, grain, 
postharvest; tomato, postharvest; and wheat, grain, postharvest. Note, 
huckleberry was listed separately from blueberry and plum was listed 
separately from plum, prune, fresh in a final rule published in the 
Federal Register of July 1, 2003 (68 FR 39435) (FRL-7316-9), which 
revised tolerance nomenclatures.
    Also, EPA is revoking 43 tolerance exemptions in 40 CFR 180.1002 
for residues of allethrin in or on apples, artichokes (Jerusalem), 
beans, beets, beets, sugar; broccoli, Brussels sprouts, cabbage, 
carrots, cauliflower, celery, chickory, chinese cabbage, citrus, 
collards, corn, endive, escarole, garlic, horseradish, kale, kohlrabi, 
leeks, lettuce, mushrooms, mustard greens, onions, parsley, parsnips, 
peaches, pears, peppers, potatoes, radishes, rutabagas, salsify, 
shallots, sorghum (milo), sorghum, grain; spinach, sweet potatoes, 
tomatoes, and turnips.
    For FQPA tolerance reassessment purposes, EPA will count the 73 
revocations as a total of 69 tolerance reassessments because in the 
baseline of tolerances to be counted toward reassessment, the tolerance 
for huckleberry is counted with blueberry, the tolerance for plum is 
counted with plum, prune, fresh; the tolerance exemption for escarole 
is counted with endive; and the tolerance exemption for sorghum milo is 
counted with the sorghum grain exemption.
    2. Bendiocarb. On April 26, 2002 (67 FR 20767) (FRL-6833-8), EPA 
published a notice in the Federal Register under section 6(f)(1) of 
FIFRA announcing its receipt of a request from the registrant for 
cancellation of the last active bendiocarb registrations for food use. 
EPA approved the registrants' requests for voluntary cancellation and 
issued cancellation orders with an effective date of October 24, 2002, 
and allowed the registrant to sell and distribute existing stocks for a 
period of 12 months after the cancellation request was received; i.e., 
until approximately April 26, 2003. There are no active registrations 
and the tolerances are no longer needed. Therefore, EPA is revoking the 
non-numerical tolerances in 40 CFR 180.530 for residues of the 
insecticide 2,2-dimethyl-1,3-benzodioxol-4-yl methylcarbamate, known as 
bendiocarb, in or on processed food and animal feed with an expiration/
revocation date of April 26, 2005, in order to allow end-users 
sufficient time to exhaust existing stocks.
    3. Burkholderia cepacia type Wisconsin. On August 28, 2002 (67 FR 
55236) (FRL-7189-4), EPA published a notice in the Federal Register 
under section 6(f)(1) of FIFRA announcing its receipt of a request from 
the registrant for cancellation of the last active Burkholderia cepacia 
type Wisconsin registrations for food use. EPA approved the 
registrant's requests for voluntary cancellation and issued 
cancellation orders with an effective date of February 27, 2003, and 
allowed the registrant to sell and distribute existing stocks for a 
period of 12 months after the cancellation request was received; i.e., 
until May 13, 2003. The Agency believes that sufficient time has passed 
for stocks to have been exhausted and for treated commodities to have 
cleared the channels of trade. Because there are no active 
registrations and the tolerance exemption is no longer needed, EPA is 
revoking the tolerance exemption in 40 CFR 180.1115 for residues of 
Burkholderia cepacia type Wisconsin in or on all raw agricultural 
commodities when applied to plant roots and seedling roots, or as a 
seed treatment for growing agricultural crops.
    4. Fenridazon potassium. On July 25, 2003 (68 FR 44081) (FRL-7315-
6), EPA

[[Page 58081]]

published a notice in the Federal Register under section 6(f)(1) of 
FIFRA announcing its receipt of a request from the registrant for 
cancellation of the last active fenridazon potassium product 
registration. EPA approved the registrants' requests for voluntary 
cancellation and issued cancellation orders on November 5, 2003 (68 FR 
62582) (FRL-7328-7), with an effective date of November 5, 2003. The 
registrant has not manufactured the canceled product since 1989. No 
existing stocks are expected to be in the channels of trade. No active 
registrations exist and therefore the tolerances are no longer needed. 
Consequently, EPA is revoking the tolerances in 40 CFR 180.423 for 
residues of the hybridizing agent potassium salt of fenridazon in or on 
cattle, fat; cattle, kidney; cattle, liver; cattle, meat; cattle, meat 
byproducts; egg; goat, fat; goat, kidney; goat, liver; goat, meat; 
goat, meat byproducts; hog, fat; hog, kidney; hog, liver; hog, meat; 
hog, meat byproducts; horse, fat; horse, kidney; horse, liver; horse, 
meat; horse, meat byproducts; milk; poultry, fat; poultry, meat; 
poultry, meat byproducts; sheep, fat; sheep, kidney; sheep, liver; 
sheep, meat; sheep, meat byproducts; wheat, grain; and wheat, straw.
    5. Molinate. On September 17, 2003 (68 FR 54451) (FRL-7324-7), EPA 
published a notice in the Federal Register under section 6(f)(1) of 
FIFRA announcing its receipt of requests from the registrants to 
voluntarily cancel registrations of all their molinate products, and to 
modify the terms and conditions of their molinate registrations. After 
considering comments received, EPA decided to accept the registrants' 
requests for voluntary cancellation. On April 7, 2004 (69 FR 18368) 
(FRL-7350-9), the Agency issued a cancellation order with an effective 
date of June 30, 2008, and a modification of the terms and conditions 
of the molinate registrations. The 2002 sales level of the molinate 
active ingredient will be the maximum amount that the registrants will 
sell or distribute in 2004, 2005, and 2006. The registrants may not 
sell or distribute any more than 75% of the 2002 sales levels in the 
year 2007, and sell or distribute more than 50% of the 2002 sales 
levels in the year 2008.
    As stated in the cancellation order of April 7, 2004 (69 FR 18368), 
registrants will provide annual production/sales reports to EPA 
beginning in the year 2004 through 2009, and inventory reports for the 
years 2007, 2008, and 2009. These reports will be submitted by 
September 30 of each year to the Agency's Chemical Review Manager for 
molinate. Failure by either registrant to comply with the sale or 
distribution limits contained in the molinate registration constitutes 
grounds for immediate cancellation of the registration without 
opportunity for a hearing.
    After June 30, 2008, the registrants may not sell or distribute any 
molinate products except to distribute the molinate active ingredient 
in 2009 for the purposes of facilitating usage by August 31, 2009. No 
use of products containing molinate will be permitted after the 2009 
growing season (August 31, 2009). Currently, this is a state 
registration under FIFRA section 24, active only in California, 
Tennessee, and Texas. Because the tolerances on rice are no longer 
needed beyond the 2009 growing season, EPA is revoking the tolerances 
in 40 CFR 180.228 for residues of the herbicide S-ethyl hexahydro-1H-
azepine-1-carbothioate, known as molinate, in or on rice, grain and 
rice, straw with an expiration/revocation date of September 1, 2009.
    Also, in 40 CFR 180.228, EPA is removing the ``(N)'' designation 
from all entries to conform to current Agency administrative practice 
(``(N)'' designation means negligible residues).

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

    It is EPA's general practice to propose revocation of tolerances 
for residues of pesticide active ingredients on crop uses for which 
FIFRA registrations no longer exist. 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 tolerances for bendiocarb and 
molinate, for which EPA is revoking certain tolerances/exemptions with 
specific expiration/revocation dates, the Agency is revoking specific 
tolerances/exemptions for allethrin, Burkholderia cepacia, and 
fenridazon potassium, and revising commodity terminologies effective on 
September 29, 2004. With the exception of bendiocarb and molinate, the 
Agency believes that existing stocks of pesticide products labeled for 
the uses associated with the revoked tolerances have been completely 
exhausted and that treated commodities have cleared the channels of 
trade. EPA is revoking certain bendiocarb and molinate tolerances with 
expiration/revocation dates of April 26, 2005, and September 1, 2009, 
respectively.
    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 residue 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 (FDA) 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 a tolerance. Evidence to show that food was 
lawfully treated may include records that verify the dates that the 
pesticide was applied to such food.

D. What is the Contribution to Tolerance Reassessment?

    By law, EPA is required by August 2006, to reassess the tolerances 
in existence on August 2, 1996. As of September 15, 2004, EPA has 
reassessed over 6,840 tolerances. In this final rule, EPA is revoking a 
total of 110 tolerances and tolerance exemptions. For FQPA tolerance 
reassessment counting purposes, EPA counts the 73 revocations for 
allethrin as 69 reassessments because the tolerances for huckleberry 
and plum are counted with blueberry and plum, prune, fresh; 
respectively, and the tolerance exemptions for escarole and sorghum 
milo are counted with endive and sorghum grain, respectively. 
Therefore, 106 tolerances/exemptions are counted as reassessed toward 
the August 2006 review deadline of FFDCA section 408(q), as amended by 
FQPA in 1996.

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

[[Page 58082]]

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 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-2004-0260 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 
29, 2004.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (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 14th 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-2004-0260, 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

    This final rule revokes specific tolerances established under 
section 408 of FFDCA. 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 final rule has been exempted from review 
under Executive Order 12866 due to its lack of significance, this final 
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 104-113, section 12(d) (15 U.S.C. 272 
note). Pursuant to

[[Page 58083]]

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 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 17, 2004.
James Jones,
Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is 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.

Sec.  180.113 [Removed]

    2. Section 180.113 is removed.
    3. Section 180.228 is amended by revising the table in paragraph 
(a) to read as follows:


Sec.  180.228  S-Ethyl hexahydro-1H-azepine-1-carbothioate; tolerances 
for residues.

    (a) * * *

------------------------------------------------------------------------
                                                             Expiration/
                   Commodity                     Parts per    Revocation
                                                  million        Date
------------------------------------------------------------------------
Rice, grain...................................          0.1       9/1/09
Rice, straw...................................          0.1       9/1/09
------------------------------------------------------------------------

* * * * *

Sec.  180.423 [Removed]

    4. Section 180.423 is removed.
    5. Section 180.530 is amended by revising paragraphs (a)(1) and 
(a)(2) to read as follows:


Sec.  180.530  2,2-Dimethyl-1,3-benzodioxol-4-yl methylcarbamate; 
tolerances for residues.

    (a) General. (1) The insecticide 2,2-dimethyl-1,3-benzodioxol-4-yl 
methylcarbamate may be safely used in spot and/or crack and crevice 
treatments in animal feed handling establishments, including feed 
manufacturing and processing establishments, such as stores, 
supermarkets, dairies, meat slaughtering and packing plants, and 
canneries until the tolerance expiration/revocation date of April 26, 
2005.
    (2) The insecticide 2,2-dimethyl-1,3-benzodioxol-4-yl 
methylcarbamate may be safely used in spot and/or crack and crevice 
treatments in food handling establishments, including food service, 
manufacturing and processing establishments, such as restaurants, 
cafeterias, supermarkets, bakeries, breweries, dairies, meat 
slaughtering and packing plants, and canneries until the tolerance 
expiration/revocation date of April 26, 2005.
* * * * *

Sec.  180.1002 [Removed]

    6. Section 180.1002 is removed.

Sec.  180.1115 [Removed]

    7. Section 180.1115 is removed.

[FR Doc. 04-21695 Filed 9-28-04; 8:45 am]
BILLING CODE 6560-50-S