[Federal Register Volume 70, Number 95 (Wednesday, May 18, 2005)]
[Proposed Rules]
[Pages 28497-28503]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-9776]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2005-0081; FRL-7713-8]
Aminopyridine, Ammonia, Chloropicrin, Diazinon, Dihydro-5-heptyl-
2(3H)-furanone, Dihydro-5-pentyl-2(3H)-furanone, and Vinclozolin;
Proposed Tolerance Actions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: This document proposes to revoke specific tolerances and
tolerance exemptions for residues of the bird repellent 4-
aminopyridine, fungicides ammonia and vinclozolin, and insecticides
chloropicrin, diazinon, dihydro-5-heptyl-2(3H)-furanone, and dihydro-5-
pentyl-2(3H)-furanone. EPA canceled food use registrations or deleted
food uses from registrations following requests for voluntary
cancellation or use deletion by the registrants, or non-payment of
registration maintenance fees. 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 under 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 that were in existence on August 2, 1996.
The regulatory actions proposed in this document pertain to the
proposed revocation of 39 tolerances and tolerance exemptions of which
33 would be counted as tolerance reassessments toward the August 2006
review deadline.
DATES: Comments must be received on or before July 18, 2005.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number OPP-2005-0081, 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-2005-0081.
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-2005-0081.
Hand Delivery: Public Information and Records Integrity
Branch (PIRIB), Office of Pesticide Programs (OPP), Environmental
Protection Agency, Rm. 119, Crystal Mall 2, 1801 S. Bell St.,
Arlington, VA, Attention: Docket ID Number OPP-2005-0081. 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-2005-
0081. 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
[[Page 28498]]
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 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)
Animal production (NAICS 112)
Food manufacturing (NAICS 311)
Pesticide manufacturing (NAICS 32532)
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in Unit 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 at 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 ID number and other
identifying information (subject heading, Federal Register date, and
page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns, and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
D. What Can I do if I Wish the Agency to Maintain a Tolerance that the
Agency Proposes to Revoke?
This proposed rule provides a comment period of 60 days for any
person to state an interest in retaining a tolerance proposed for
revocation. If EPA receives a comment within the 60-day period to that
effect, EPA will not proceed to revoke the tolerance immediately.
However, EPA will take steps to ensure the submission of any needed
supporting data and will issue an order in the Federal Register under
FFDCA section 408(f) if needed. The order would specify data needed and
the time frames for its submission, and would require that within 90
days some person or persons notify EPA that they will submit the data.
If the data are not submitted as required in the order, EPA will take
appropriate action under FFDCA.
EPA issues a final rule after considering comments that are
submitted in response to this proposed rule. In addition to submitting
comments in response to this proposal, you may also submit an objection
at the time of the final rule. If you fail to file an objection to the
final rule within the time period specified, you will have waived the
right to raise any issues resolved in the final rule. After the
specified time, issues resolved in the final rule cannot be raised
again in any subsequent proceedings.
II. Background
A. What Action is the Agency Taking?
EPA is proposing to revoke certain specific tolerances and
tolerance exemptions for residues of the bird repellent 4-
aminopyridine, fungicides ammonia and vinclozolin, and insecticides
chloropicrin, diazinon, dihydro-5-heptyl-2(3H)-furanone, and dihydro-5-
pentyl-2(3H)-furanone because these specific tolerances and tolerance
exemptions correspond to uses which are no longer current or registered
under 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
[[Page 28499]]
proposal indicates a need for the tolerance to cover residues in or on
imported commodities or domestic commodities legally treated.
1. 4-Aminopyridine. In the Federal Register notice of October 27,
2004 (69 FR 62666) (FRL-7683-7), EPA announced registration
cancellations, including certain 4-aminopyridine (avitrol)
registrations, for non-payment of year 2004 registration maintenance
fees. The cancellation orders permitted registrants to sell and
distribute existing stocks of the canceled products until January 15,
2005, 1 year after the date on which the fee was due. Earlier, on
December 17, 2003, the registrant had submitted a written request for
voluntary cancellation of the food uses of 4-aminopyridine. The Agency
believes that end users will have sufficient time to exhaust existing
stocks and for treated commodities to have cleared the channels of
trade by January 15, 2006. Therefore, EPA is proposing to revoke the
tolerances in 40 CFR 180.312 for residues of the bird repellent 4-
aminopyridine in or on corn, forage; corn, field, grain; corn, pop,
grain; corn, stover; corn, sweet, kernels plus cob with husks removed;
and sunflower, seed with an expiration/revocation date of January 15,
2006.
Also, EPA is proposing to revise the commodity terminology in 40
CFR 180.312 to conform to current Agency practice as follows: ``corn,
forage'' to ``corn, field, forage'' and ``corn, sweet, forage;''
``corn, stover'' to ``corn, field, stover;'' ``corn, pop, stover;'' and
``corn, sweet, stover;'' and ``corn, sweet, kernels plus cob with husks
removed'' to ``corn, sweet, kernel plus cob with husks removed.'' In
addition, in 40 CFR 180.312, EPA is proposing to remove the ``(N)''
designation from all entries to conform to current Agency
administrative practice (``(N)'' designation means negligible
residues).
2. Ammonia. Because there have been no active registered uses of
ammonia on food since 1987, the associated tolerance exemptions are no
longer needed. Therefore, EPA is proposing to revoke the tolerance
exemptions in 40 CFR 180.1003 for residues of the fungicide ammonia
when used after harvest on grapefruit, lemons, oranges, and corn grain
for feed use only.
3. Chloropicrin. Because there have been no active registrations of
chloropicrin concerning post-harvest uses on grain since 1991, the
associated tolerance exemptions are no longer needed. Also, the Agency
believes that chloropicrin is not found in the formulation of other
fumigant pesticides with active registrations for post-harvest use on
grains. In addition, the Agency believes that it is unlikely that
detectable residues of chloropicrin will be found in or on any raw
agricultural commodity in formulations where it is used as a warning
agent (2% or less) due to its volatility.
Therefore, EPA is proposing to revoke the tolerance exemptions in
40 CFR 180.1008 for residues of chloropicrin when used as a fumigant
after harvest on barley, buckwheat, corn (including popcorn), oats,
rice, rye, grain sorghum, and wheat.
4. Diazinon. In the Federal Register notice of May 30, 2001 (66 FR
29310) (FRL-6785-2), EPA announced the receipt of requests to
voluntarily cancel and amend certain diazinon registrations. The Agency
published the cancellation order in the Federal Register of July 19,
2001 (66 FR 37673)(FRL-6791-9) and made the registration cancellations
and amendments effective on July 19, 2001, and registrant sale and
distribution of existing stocks was permitted for 1 year; i.e., until
July 19, 2002.
Also, in the Federal Register notice of September 13, 2001 (66 FR
47658) (FRL-6800-6), EPA announced the receipt of requests to
voluntarily cancel and amend certain diazinon registrations. The Agency
published the cancellation order in the Federal Register of November
15, 2001 (66 FR 57440)(FRL-6809-5) and made the registration
cancellations and amendments effective on November 15, 2001, and
registrant sale and distribution of existing stocks was permitted for
one year; i.e., until November 15, 2002.
EPA believes that end users have had sufficient time, more than 2
years, to exhaust those existing stocks and for treated commodities to
have cleared the channels of trade. Therefore, the Agency is proposing
to revoke the tolerances in 40 CFR 180.153 for residues of the
insecticide diazinon in or on alfalfa, fresh; alfalfa, hay; guar, seed;
clover, forage; clover, hay; cotton, undelinted seed; cowpea; cowpea,
forage; lespedeza; sorghum, forage; and sorghum, grain; and all
revocations to be effective on the date of publication of the final
rule in the Federal Register.
Further, EPA is proposing to revise commodity terminology in 40 CFR
180.153 to conform to current Agency practice as follows: ``Banana (NMT
0.1 ppm shall be present in the pulp after peel is removed)'' to
``banana;'' ``corn, forage'' to ``corn, field, forage'' and ``corn,
sweet, forage;'' ``corn, kernel plus cob with husks'' to ``corn, sweet,
kernel plus cob with husks removed;'' ``endive (escarole)'' to
``endive;'' ``ginseng, root'' to ``ginseng, roots;'' ``hop'' to ``hop,
dried cones;'' ``onion'' to ``onion, dry bulb'' and ``onion, green;''
``peavine hay'' to ``pea, field, hay;'' ``peavines'' to ``pea, field,
vines;'' ``pea with pods (determined on pea after removing any shell
present when marketed)'' to ``pea, succulent;'' and `` rutabagas'' to
``rutabaga.``
Additional information can be found in the 2002 diazinon Interim
Reregistration Eligibility Decision (IRED). A printed copy of the
diazinon IRED may be obtained from EPA's National Service Center for
Environmental Publications (EPA/NSCEP), P.O. Box 42419, Cincinnati, OH
45242-2419, telephone 1-800-490-9198; fax 1-513-489-8695; internet at
http://www.epa.gov/ncepihom/ and from the National Technical
Information Service (NTIS), 5285 Port Royal Road, Springfield, VA
22161, telephone 1-800-553-6847 or 703-605-6000; internet at http://www.ntis.gov/. An electronic copy of the diazinon IRED is available on
the internet at http://www.epa.gov/pesticides/reregistration/status.htm.
On March 23, 2005 (70 FR 14618) (FRL-7701-4), EPA published in the
Federal Register a proposed rule which included a proposal to revoke
diazinon tolerances in 40 CFR 180.153 on coffee bean and dandelion,
leaves effective on the date of final rule publication. Because EPA
expects the final rule follow-up to the March 23, 2005 proposal to be
published in the Federal Register prior to follow-up publication of a
final rule action to this document, the Agency does not show either the
coffee bean or dandelion, leaves tolerances in the codification table
for diazinon in this document. However, if these two tolerances are not
revoked prior to final action on this document, then the Agency will
list them in the codification table for diazinon in that final rule.
5. Dihydro-5-heptyl-2(3H)-furanone. In the Federal Register notice
of October 27, 2004 (69 FR 62666), EPA announced registration
cancellations, including a certain dihydro-5-heptyl-2(3H)-furanone
registration, for non-payment of year 2004 registration maintenance
fees. The cancellation orders permitted registrants to sell and
distribute existing stocks of the canceled products until January 15,
2005, one year after the date on which the fee was due. The Agency
believes that end users have had sufficient time to exhaust existing
stocks and for treated commodities to have cleared the channels of
trade. Therefore, EPA is proposing to revoke the tolerance exemptions
in 40 CFR 180.528 for residues of the insecticide dihydro-5-
[[Page 28500]]
heptyl-2(3H)-furanone in or on animal feed and processed food.
Also, EPA is proposing to revise paragraph (a)(1) in 40 CFR 180.539
and remove dihydro-5-heptyl-2(3H)-furanone from the tolerance exemption
expression for d-Limonene.
6. Dihydro-5-pentyl-2(3H)-furanone. In the Federal Register notice
of October 27, 2004 (69 FR 62666), EPA announced registration
cancellations, including a certain dihydro-5-pentyl-2(3H)-furanone
registration, for non-payment of year 2004 registration maintenance
fees. The cancellation orders permitted registrants to sell and
distribute existing stocks of the canceled products until January 15,
2005, one year after the date on which the fee was due. The Agency
believes that end users have had sufficient time to exhaust existing
stocks and for treated commodities to have cleared the channels of
trade. Therefore, EPA is proposing to revoke the tolerance exemptions
in 40 CFR 180.529 for residues of the insecticide dihydro-5-pentyl-
2(3H)-furanone in or on animal feed and processed food.
Also, EPA is proposing to revise paragraph (a)(1) in 40 CFR 180.539
and remove dihydro-5-pentyl-2(3H)-furanone from the tolerance exemption
expression for d-Limonene.
7. Vinclozolin. In the Federal Register notice of August 22, 2001
(66 FR 44134) (FRL-6795-7), EPA announced use cancellations for certain
vinclozolin registrations, including uses of the fungicide vinclozolin
on kiwi, chicory, lettuce, and succulent beans with a last date for
legal use as January 30, 2004; January 30, 2004; November 30, 2005, and
November 30, 2005, respectively. The Agency believes that end users
will have had sufficient time to exhaust existing stocks and for
treated kiwi and chicory commodities to have cleared the channels of
trade. Further, pursuant to FFDCA section 408(l)(5), treated lettuce
and succulent bean commodities that have been legally treated on or
before November 30, 2005 and whose residues are within the tolerance
set to expire on that date, will not be considered adulterated, even if
they have not yet cleared channels of trade. Therefore, EPA is
proposing to revoke the tolerances in 40 CFR 180.380(a) for the
combined residues of the fungicide vinclozolin and its metabolites
containing the 3,5-dichloroaniline moiety in or on Belgian endive, tops
and kiwifruit on the date of publication of the final rule, and also
lettuce, head and lettuce, leaf; each with an expiration/revocation
dates date of November 30, 2005.
Also, while the tolerance for vinclozolin residues of concern in or
on bean, succulent currently has an expiration/revocation date of
September 30, 2005 in 40 CFR 180.380(a), EPA is proposing to extend
that date until November 30, 2005 in order to be consistent with the
last date for legal use identified in the Federal Register Notice of
August 22, 2001 (66 FR 44134).
Further, EPA is proposing to revise commodity terminology in the
table in 40 CFR 180.380(a) to conform to current Agency practice as
follows: ``grape, (wine)'' to `` grape, wine.''
On March 23, 2005 (70 FR 14618), EPA published in the Federal
Register a rule which included a proposal to revoke vinclozolin
tolerances in 40 CFR 180.380 on onion, dry bulb and raspberry effective
on the date of final rule publication. Because EPA expects the final
rule follow-up to the March 23, 2005 proposal to be published in the
Federal Register prior to follow-up publication of a final rule action
to this document, the Agency does not show either the onion, dry bulb
or raspberry tolerances in the codification table for vinclozolin in
this document. However, if these two tolerances are not revoked prior
to final action on this document, then the Agency will list them in the
codification table for vinclozolin in that final rule.
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. 346a,
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. Without a tolerance or exemption, food containing
pesticide residues is considered to be unsafe and therefore
``adulterated'' under section 402(a) of the FFDCA, 21 U.S.C. 342(a).
Such food may not be distributed in interstate commerce (21 U.S.C.
331(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. 136 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
[[Page 28501]]
408(f), if the Agency determines that additional information is
reasonably required to support the continuation of a tolerance, EPA may
require that parties interested in maintaining the tolerances provide
the necessary information. If the requisite information is not
submitted, EPA may issue an order revoking the tolerance at issue.
C. When do These Actions Become Effective?
With the exception of certain tolerances for 4-aminopyridine and
vinclozolin, for which EPA is proposing specific expiration/revocation
dates, the Agency is proposing that these tolerance and tolerance
exemption revocations, tolerance commodity terminology revisions, and
removal of dihydro-5-heptyl-2(3H)-furanone and dihydro-5-pentyl-2(3H)-
furanone from the tolerance expression in 40 CFR 180.539 for d-limonene
become effective on the date of publication of the final rule in the
Federal Register. With the exception of 4-aminopyridine and
vinclozolin, the Agency believes that existing stocks of pesticide
products labeled for the uses associated with the tolerance actions
proposed herein have been exhausted and that treated commodities have
cleared the channels of trade. EPA is proposing expiration dates of
January 15, 2006 for specific 4-aminopyridine tolerances and November
30, 2005 for tolerances of vinclozolin residues of concern on bean,
succulent; lettuce, head; and lettuce, leaf. 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 other information and that
information is verified, the Agency will consider extending the
expiration date of the tolerance. If you have comments regarding
existing stocks and whether the effective date allows sufficient time
for treated commodities to clear the channels of trade, please submit
comments as described under SUPPLEMENTARY INFORMATION.
Any commodities listed in this proposal treated with the pesticides
subject to this proposal, and in the channels of trade following the
tolerance revocations, shall be subject to FFDCA section 408(1)(5), as
established by FQPA. Under this section, any residues of these
pesticides in or on such food shall not render the food adulterated so
long as it is shown to the satisfaction of the Food and Drug
Administration that: (1) The residue is present as the result of an
application or use of the pesticide at a time and in a manner that was
lawful under FIFRA, and (2) the residue does not exceed the level that
was authorized at the time of the application or use to be present on
the food under a tolerance or exemption from tolerance. Evidence to
show that food was lawfully treated may include records that verify the
dates when 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
that were in existence on August 2, 1996. As of May 6, 2005, EPA has
reassessed over 7,190 tolerances. This document proposes to revoke a
total of 39 tolerances of which 33 would be counted in a final rule as
tolerance reassessments toward the August 2006 review deadline under
FFDCA section 408(q), as amended by FQPA in 1996. For the purpose of
tolerance reassessment, the commodity entry ``corn (including
popcorn)'' in 40 CFR 180.1008 for chloropicrin represents two
tolerances; i.e., corn (postharvest) and corn, pop, grain
(postharvest). Therefore, it is counted herein as two proposed
revocations and the Agency expects in a final rule to count this as two
tolerance reassessments. In addition, while the corn, field, grain and
corn, pop, grain tolerances for 4-aminopyridine are counted as two
proposed revocations, EPA expects in a final rule to count them as one
tolerance reassessment because the Agency counted them as one tolerance
at the beginning of FQPA when these were listed in 40 CFR 180.312 as
one tolerance; i.e., corn, grain. Finally, the vinclozolin tolerances
were previously reassessed.
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 standard 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.,
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
[[Page 28502]]
Agency consideration of voluntary consensus standards pursuant to
section 12(d) of the National Technology Transfer and Advancement Act
of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note). Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
et seq.), the Agency previously assessed whether revocations of
tolerances might significantly impact a substantial number of small
entities and concluded that, as a general matter, these actions do not
impose a significant economic impact on a substantial number of small
entities. This analysis was published on December 17, 1997 (62 FR
66020), and was provided to the Chief Counsel for Advocacy of the Small
Business Administration. Taking into account this analysis, and
available information concerning the pesticides listed in this rule,
the Agency hereby certifies that this proposed action will not have a
significant economic impact on a substantial number of small entities.
Specifically, as per the 1997 notice, EPA has reviewed its available
data on imports and foreign pesticide usage and concludes that there is
a reasonable international supply of food not treated with canceled
pesticides. Furthermore, for the pesticides named in this proposed
rule, the Agency knows of no extraordinary circumstances that exist as
to the present proposal that would change the EPA's previous analysis.
Any comments about the Agency's determination should be submitted to
the EPA along with comments on the proposal, and will be addressed
prior to issuing a final rule. In addition, the Agency has determined
that this action will not have a substantial direct effect on States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government, as specified in Executive Order 13132, entitled
Federalism (64 FR 43255, August 10, 1999). Executive Order 13132
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by State and local officials in the development of
regulatory policies that have federalism implications.'' ``Policies
that have federalism implications'' is defined in the Executive order
to include regulations that have ``substantial direct effects on the
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government.'' This proposed rule directly regulates
growers, food processors, food handlers and food retailers, not States.
This action does not alter the relationships or distribution of power
and responsibilities established by Congress in the preemption
provisions of section 408(n)(4) of the FFDCA. For these same reasons,
the Agency has determined that this proposed rule does not have any
``tribal implications'' as described in Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive Order 13175, requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by tribal officials in the development of regulatory policies that have
tribal implications.'' ``Policies that have tribal implications'' is
defined in the Executive order to include regulations that have
``substantial direct effects on one or more Indian tribes, on the
relationship between the Federal Government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes.'' This proposed rule will not have
substantial direct effects on tribal governments, on the relationship
between the Federal Government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does notapply 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: May 6, 2005.
James Jones,
Director, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR part 180 be amended as
follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.153 is amended by revising the table in paragraph
(a)(1) to read as follows:
Sec. 180.153 Diazinon; tolerances for residues.
(a) General. (1) * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Almond......................................... 0.5
Almond, hulls.................................. 3.0
Apple.......................................... 0.5
Apricot........................................ 0.5
Banana......................................... 0.2
Bean, lima..................................... 0.5
Bean, snap, succulent.......................... 0.5
Beet, garden, roots............................ 0.75
Beet, garden, tops............................. 0.7
Beet, sugar, roots............................. 0.5
Beet, sugar, tops.............................. 10.0
Blackberry..................................... 0.5
Blueberry...................................... 0.5
Carrot, roots.................................. 0.75
Cattle, fat.................................... 0.7
Celery......................................... 0.7
Cherry......................................... 0.75
Citrus......................................... 0.7
Corn, field, forage............................ 40.0
Corn, sweet, kernel plus cob with husks removed 0.7
Corn, sweet, forage............................ 40.0
Cranberry...................................... 0.5
Cucumber....................................... 0.75
Endive......................................... 0.7
Fig............................................ 0.5
Filbert........................................ 0.5
Ginseng, roots................................. 0.75
Grape.......................................... 0.75
Hop, dried cones............................... 0.75
Kiwifruit...................................... 0.75
Lettuce........................................ 0.7
Loganberry..................................... 0.75
Melon.......................................... 0.75
Mushroom....................................... 0.75
Nectarine...................................... 0.5
Olive.......................................... 1.0
Onion, dry bulb................................ 0.75
Onion, green................................... 0.75
Parsley, leaves................................ 0.75
Parsnip........................................ 0.5
Peach.......................................... 0.7
Pear........................................... 0.5
Pea, field, hay................................ 10.0
Pea, field, vines.............................. 25.0
Pea, succulent................................. 0.5
Pepper......................................... 0.5
Pineapple...................................... 0.5
Plum, prune, fresh............................. 0.5
Potato......................................... 0.1
Potato, sweet.................................. 0.1
Radicchio...................................... 0.7
Radish......................................... 0.5
Raspberry...................................... 0.5
Rutabaga....................................... 0.75
Sheep, fat..................................... 0.7
Sheep, meat (fat basis)........................ 0.7
Sheep, meat byproducts (fat basis)............. 0.7
Spinach........................................ 0.7
Squash, summer................................. 0.5
Squash, winter................................. 0.75
Strawberry..................................... 0.5
Swiss chard.................................... 0.7
Tomato......................................... 0.75
Turnip, roots.................................. 0.5
Turnip, greens................................. 0.75
Vegetable, brassica, leafy, group 5............ 0.7
[[Page 28503]]
Walnut......................................... 0.5
Watercress..................................... 0.7
------------------------------------------------------------------------
* * * * *
3. Section 180.312 is amended by revising paragraph (a) to read as
follows:
Sec. 180.312 4-Aminopyridine; tolerances for residues.
(a) General. Tolerances are established for residues of the bird
repellent 4-aminopyridine in or on the following food commodities:
------------------------------------------------------------------------
Parts per Expiration/
Commodity million Revocation Date
------------------------------------------------------------------------
Corn, field, forage.................. 0.1 1/15/06
Corn, field, grain................... 0.1 1/15/06
Corn, field, stover.................. 0.1 1/15/06
Corn, pop, grain..................... 0.1 1/15/06
Corn, pop, stover.................... 0.1 1/15/06
Corn, sweet, forage.................. 0.1 1/15/06
Corn, sweet, kernel plus cob with 0.1 1/15/06
husks removed.......................
Corn, sweet, stover.................. 0.1 1/15/06
Sunflower, seed...................... 0.1 1/15/06
------------------------------------------------------------------------
* * * * *
4. Section 180.380 is amended by revising paragraph (a) to read as
follows:
Sec. 180.380 Vinclozolin; tolerances for residues.
(a) General. Tolerances are established for the combined residues
of the fungicide vinclozolin (3-(3,5-dichlorophenyl)-5-ethenyl-5-
methyl-2,4-oxazolidinedione) and its metabolites containing the 3,5-
dichloroaniline moiety in or on the food commodities in the table
below. There are no U.S. registrations for grape (wine) as of July 30,
1997.
------------------------------------------------------------------------
Parts per Expiration/
Commodity million Revocation Date
------------------------------------------------------------------------
Bean, succulent...................... 2.0 11/30/05
Canola, seed......................... 1.0 11/30/08
Cattle, fat.......................... 0.05 11/30/08
Cattle, meat......................... 0.05 11/30/08
Cattle, meat byproducts.............. 0.05 11/30/08
Egg.................................. 0.05 11/30/08
Goat, fat............................ 0.05 11/30/08
Goat, meat........................... 0.05 11/30/08
Goat, meat byproducts................ 0.05 11/30/08
Grape, wine.......................... 6.0 None
Hog, fat............................. 0.05 11/30/08
Hog, meat............................ 0.05 11/30/08
Hog, meat byproducts................. 0.05 11/30/08
Horse, fat........................... 0.05 11/30/08
Horse, meat.......................... 0.05 11/30/08
Horse, meat byproducts............... 0.05 11/30/08
Lettuce, head........................ 10.0 11/30/05
Lettuce, leaf........................ 10.0 11/30/05
Milk................................. 0.05 11/30/08
Poultry, fat......................... 0.1 11/30/08
Poultry, meat........................ 0.1 11/30/08
Poultry, meat byproducts............. 0.1 11/30/08
Sheep, fat........................... 0.05 11/30/08
Sheep, meat.......................... 0.05 11/30/08
Sheep, meat byproducts............... 0.05 11/30/08
------------------------------------------------------------------------
* * * * *
Sec. 180.528 [Removed]
5. Section 180.528 is removed.
Sec. 180.529 [Removed]
6. Section 180.529 is removed.
7. Section 180.539 is amended by revising paragraph (a)(1) to read
as follows:
Sec. 180.539 d-Limonene; tolerances for residues.
(a) General. (1) The insecticide d-limonene may be safely used in
insect-repellent tablecloths and in insect-repellent strips used in
food- or feed-handling establishments.
* * * * *
Sec. 180.1003 [Removed]
8. Section 180.1003 is removed.
Sec. 180.1008 [Removed]
9. Section 180.1008 is removed.
[FR Doc. 05-9776 Filed 5-17-05; 8:45 a.m.]
BILLING CODE 6560-50-S