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Allethrin, Bendiocarb, Burkholderia cepacia, Fenridazon potassium, and Molinate; Proposed Tolerance Actions
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: July 7, 2004 (Volume 69, Number 129)]
[Proposed Rules]
[Page 40831-40836]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07jy04-27]
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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.
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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.regulations.gov/. 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-2004-0140.
? 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.regulations.gov/, 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.regulations.gov/. 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: 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
[[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.regulations.gov/), 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
(59 FR 22951, 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]
? 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. 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]
? 4. Section 180.423 is removed.
? 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]
? 6. Section 180.1002 is removed.
Sec. 180.1115 [Removed]
? 7. Section 180.1115 is removed.
[FR Doc. 04-15211 Filed 7-6-04; 8:45 am]
BILLING CODE 6560-50-S