[Federal Register Volume 69, Number 129 (Wednesday, July 7, 2004)]
[Proposed Rules]
[Pages 40831-40836]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-15211]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0140; FRL-7362-2]


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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: This document proposes to revoke 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. EPA expects to 
determine whether any individuals or groups want to support these 
tolerances. The regulatory actions proposed 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 proposed in this document pertain to the 
proposed revocation of 110 tolerances and tolerance exemptions of which 
106 would be counted as tolerance reassessments toward the August 2006 
review deadline.

DATES: Comments must be received on or before September 7, 2004.

ADDRESSES:  Submit your comments, identified by docket ID number OPP-
2004-0140, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov/. 
Follow the on-line instructions for submitting comments.
     Agency Website: http://www.epa.gov/edocket/. EDOCKET, 
EPA's electronic public docket and comment system, is EPA's preferred 
method for receiving comments. Follow the on-line instructions for 
submitting comments.
     E-mail: Comments may be sent by e-mail to [email protected], Attention: Docket ID Number OPP-2004-0140.
     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-2004-0140.
      Hand Delivery/carrier: Public Information and Records 
Integrity Branch (PIRIB), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, Rm. 119, Crystal Mall 2, 1801 
Bell Street, Arlington, VA, Attention: Docket ID Number OPP-2004-0140. 
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-
0140. EPA's policy is that all comments received will be included in 
the public docket without change and may be made available online at 
http://www.epa.gov/edocket/, including any personal information 
provided, unless the comment includes information claimed to be 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Do not submit information that you 
consider to be CBI or otherwise protected through EDOCKET, 
regulations.gov, or e-mail. The EPA EDOCKET and the regulations.gov 
websites are ``anonymous access'' systems, which means EPA will not 
know your identity or contact information unless you provide it in the 
body of your comment. If you send an e-mail comment directly to EPA 
without going through EDOCKET or regulations.gov, your e-mail address 
will be automatically captured and included as part of the comment that 
is placed in the public docket and made available on the Internet. If 
you submit an electronic comment, EPA recommends that you include your 
name and other contact information in the body of your comment and with 
any disk or CD ROM you submit. If EPA cannot read your comment due to 
technical difficulties and cannot contact you for clarification, EPA 
may not be able to consider your comment. Electronic files should avoid 
the use of special characters, any form of encryption, and be free of 
any defects or viruses. For additional information about EPA's public 
docket visit EDOCKET on-line or see the Federal Register of May 31, 
2002 (67 FR 38102) (FRL-7181-7).
    Docket: All documents in the docket are listed in the EDOCKET index 
at http://www.epa.gov/edocket/. Although listed in the index, some 
information is not publicly available, i.e., CBI or other information 
whose disclosure is restricted by statute. Certain other material, such 
as copyrighted material, is not placed on the Internet and will be 
publicly available only in hard copy form. Publicly available docket 
materials are available either electronically in EDOCKET or in hard 
copy at the Public Information and Records Integrity Branch (PIRIB), 
Rm. 119, Crystal Mall 2, 1801 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)
     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

[[Page 40832]]

for readers regarding entities likely to be affected by this action. 
Other types of entities not listed in this unit could also be affected. 
The North American Industrial Classification System (NAICS) codes have 
been provided to assist you and others in determining whether this 
action might apply to certain entities. To determine whether you or 
your business may be affected by this action, you should carefully 
examine the applicability provisions in Unit IIA. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

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

    In addition to using EDOCKET (http://www.epa.gov/edocket/), you may 
access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 
is available on E-CFR Beta Site Two at  http://www.gpoaccess.gov/ecfr/.

C. What Should I Consider as I Prepare My Comments for EPA?

    1.  Submitting CBI. Do not submit this information to EPA through 
EDOCKET, regulations.gov, or e-mail. Clearly mark the part or all of 
the information that you claim to be CBI. For CBI information in a disk 
or CD ROM that you mail to EPA, mark the outside of the disk or CD ROM 
as CBI and then identify electronically within the disk or CD ROM the 
specific information that is claimed as CBI). In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in 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 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 certain tolerances 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 correspond to 
uses no longer current or registered under the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA) in the United States. It is 
EPA's general practice to propose revocation of those tolerances for 
residues of pesticide active ingredients on crop uses for which there 
are no active registrations under FIFRA, unless any person in comments 
on the proposal indicates a need for the tolerance to cover residues in 
or on imported commodities or domestic commodities legally treated.
    1.  Allethrin. Many food use registrations for allethrin were 
cancelled in 1989 and 1991 due to non-payment of maintenance fees. In 
the Federal Register of March 18, 2002, (67 FR 11965) (FRL-6826-6) EPA 
had proposed the revocation of 60 tolerances in 40 CFR 180.113 and 
tolerance exemptions in 40 CFR 180.1002 for residues of the insecticide 
allethrin in or on certain commodities because it was no longer 
registered under FIFRA for use on those commodities. Other tolerances 
were not proposed for revocation at that time, including tolerances for 
the grains of barley, corn, oats, popcorn, rye, sorghum, and wheat and 
tolerance exemptions for corn, popcorn, mushroom, and sorghum grain. 
During the 60-day public comment period provided by that proposal, the 
registrant, Valent BioSciences Corporation, expressed concern in a 
letter dated April 15, 2002 that allethrin needed to be defined prior 
to any revocations because there are several stereoisomers of allethrin 
(004001). Valent noted that such revocations would not affect domestic 
uses of the allethrins. However, Valent asked that the Agency identify 
the compound or compounds associated with the tolerances and tolerance 
exemptions proposed for revocation so that it could consider whether to 
support any tolerances for importation purposes concerning allethrin 
stereoisomers; i.e., bioallethrin, s-bioallethrin, or d-cis-trans-
allethrin.
    The other allethrin stereoisomers (bioallethrin, 004003; s-
bioallethrin, 004004; and d-cis-trans-allethrin, 004005) are later 
mixtures that are more refined for the ``d-trans of d'' isomer, which 
appears to have the primary pesticidal effect. After reviewing labels 
for these allethrin-stereoisomer active ingredients, 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). These allethrin stereoisomers 
are primarily used as flying insect killers and repellents.
    During April 2004, in communications with Valent BioSciences, EPA 
defined the tolerances

[[Page 40833]]

in 40 CFR 180.113 and tolerance exemptions in 40 CFR 180.1002 as 
associated with residues of allethrin (004001) as the sole active 
ingredient; i.e., these tolerances and exemptions are not associated 
with residues of other stereoisomers (004003, 004004, or 004005). Also, 
the Agency asked Valent to clarify any need to support tolerances for 
purposes of importation. In a communication dated April 21, 2004, 
Valent answered that it now has no concerns regarding a need to support 
import tolerances for allethrin (004001).
    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 proposing to revoke 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 on July 1, 2003 (68 FR 
39435) (FRL-7316-9) which revised tolerance nomenclatures.
    Also, EPA is proposing to revoke 43 tolerance exemptions in 
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 expects to 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 proposing to 
revoke 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 channels of trade. Because there are no active registrations 
and the tolerance exemption is no longer needed, EPA is proposing to 
revoke 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 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 proposing to revoke 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; all to be revoked effective on the date of publication of 
the final rule in the Federal Register.
    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.

[[Page 40834]]

    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 proposing to revoke 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 proposing to remove 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?

    A ``tolerance'' represents the maximum level for residues of 
pesticide chemicals legally allowed in or on raw agricultural 
commodities and processed foods. Section 408 of FFDCA, 21 U.S.C. 301 et 
seq., as amended by the FQPA of 1996, Public Law 104-170, authorizes 
the establishment of tolerances, exemptions from tolerance 
requirements, modifications in tolerances, and revocation of tolerances 
for residues of pesticide chemicals in or on raw agricultural 
commodities and processed foods (21 U.S.C. 346(a)). Without a tolerance 
or exemption, food containing pesticide residues is considered to be 
unsafe and therefore ``adulterated'' under section 402(a) of the FFDCA. 
Such food may not be distributed in interstate commerce (21 U.S.C. 
331(a) and 342(a)). For a food-use pesticide to be sold and 
distributed, the pesticide must not only have appropriate tolerances 
under the FFDCA, but also must be registered under FIFRA (7 U.S.C. et 
seq.). Food-use pesticides not registered in the United States must 
have tolerances in order for commodities treated with those pesticides 
to be imported into the United States.
    EPA'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?

    For this proposed rule, the proposed revocations will affect 
tolerances for uses which have been canceled, in some cases, for many 
years. With the exception of certain tolerances for bendiocarb and 
molinate, for which EPA is proposing specific expiration/revocation 
dates, the Agency is proposing that the revocations for allethrin, 
Burkholderia cepacia and fenridazone potassium become effective on the 
date of publication for the final rule in the Federal Register. With 
the exception of bendiocarb and molinate, the Agency believes that 
existing stocks of pesticide products labeled for the uses associated 
with the tolerances proposed for revocation have been completely 
exhausted and that treated commodities have cleared the channels of 
trade. EPA is proposing expiration/revocation dates of April 26, 2005 
for specific bendiocarb tolerances and September 1, 2009 for specific 
molinate tolerances. The Agency believes that these revocation dates 
allow users to exhaust stocks and allow sufficient time for passage of 
treated commodities 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

[[Page 40835]]

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.

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 June 21, 2004, EPA has reassessed 
over 6,670 tolerances. This document proposes to revoke a total of 110 
tolerances and tolerance exemptions of which 106 would be counted as 
tolerance reassessments toward the August, 2006 review deadline of 
FFDCA section 408(q), as amended by FQPA in 1996.

III. Are The Proposed Actions Consistent with International 
Obligations?

    The tolerance revocations in this proposal are not discriminatory 
and are designed to ensure that both domestically-produced and imported 
foods meet the food safety standards established by the FFDCA. The same 
food safety standards apply to domestically produced and imported 
foods.
    EPA is working to ensure that the U.S. tolerance reassessment 
program under FQPA does not disrupt international trade. EPA considers 
Codex Maximum Residue Limits (MRLs) in setting U.S. tolerances and in 
reassessing them. MRLs are established by the Codex Committee on 
Pesticide Residues, a committee within the Codex Alimentarius 
Commission, an international organization formed to promote the 
coordination of international food standards. It is EPA's policy to 
harmonize U.S. tolerances with Codex MRLs to the extent possible, 
provided that the MRLs achieve the level of protection required under 
FFDCA. EPA's effort to harmonize with Codex MRLs is summarized in the 
tolerance reassessment section of individual Reregistration Eligibility 
Decision documents. EPA has developed guidance concerning submissions 
for import tolerance support (65 FR 35069, June 1, 2000) (FRL-6559-3). 
This guidance will be made available to interested persons. Electronic 
copies are available on the internet at http://www.epa.gov/. On the 
Home Page select ``Laws, Regulations, and Dockets,'' then select 
``Regulations and Proposed Rules'' and then look up the entry for this 
document under ``Federal Register--Environmental Documents.'' You can 
also go directly to the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/.

IV. Statutory and Executive Order Reviews

    In this proposed rule EPA is proposing to revoke 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 
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 proposed 
rule, I certify that this 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 pesticides named in this proposed rule, the Agency 
knows of no extraordinary circumstances that exist as to the present 
proposed revocations 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

[[Page 40836]]

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: June 21, 2004.
James Jones,
Director, Office of Pesticide Programs.
    Therefore, it is proposed that 40 CFR chapter I be 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.


Sec.  180.113  [Removed]

0
2. Section 180.113 is removed.
0
3. In Sec.  180.228, the table in paragraph (a), is revised to read as 
follows:


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

    (a) * * *

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

* * * * *


Sec.  180.423  [Removed]

0
4. Section 180.423 is removed.
0
5. In Sec.  180.530 paragraphs (a)(1) and (2) are revised 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]

0
6. Section 180.1002 is removed.


Sec.  180.1115  [Removed]

0
7. Section 180.1115 is removed.
[FR Doc. 04-15211 Filed 7-6-04; 8:45 am]
BILLING CODE 6560-50-S