[Federal Register: August 1, 2007 (Volume 72, Number 147)]
[Rules and Regulations]
[Page 41913-41931]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01au07-13]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2004-0154; FRL-8139-5]
Bromoxynil, Diclofop-methyl, Dicofol, Diquat, Etridiazole, et
al.; Tolerance Actions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: EPA is revoking certain tolerances for the herbicides
bromoxynil, diclofop-methyl, and paraquat; the fungicide etridiazole
(terrazole); the miticides dicofol and propargite; and the plant growth
regulator and herbicide diquat. Also, EPA is removing duplicate
tolerances for the herbicides bromoxynil, paraquat, and picloram; the
fumigant phosphine; the miticide dicofol; and the insecticides
fenbutatin-oxide and hydramethylnon. In addition, EPA is modifying
certain tolerances for the insecticide hydramethylnon; the herbicides
bromoxynil, paraquat, and triclopyr; the fungicides etridiazole,
folpet, and triphenyltin hydroxide (TPTH); the miticides dicofol and
propargite; and the plant growth regulator and herbicide diquat.
Moreover, EPA is establishing new tolerances for the herbicides
bromoxynil, paraquat, and picloram; the fungicides etridiazole, folpet,
and TPTH; the miticides dicofol and propargite; the insecticide
fenbutatin-oxide; and the plant growth regulator and herbicide diquat.
The regulatory actions in this document are follow-up to the Agency's
reregistration program under the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), and reassessment program under the Federal
Food, Drug, and Cosmetic Act (FFDCA) section 408(q).
DATES: This regulation is effective October 30, 2007. Objections and
requests for hearings must be received on or before October 1, 2007,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2004-0154. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov web site to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at http://www.regulations.gov, or,
if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive,
Arlington, VA. The 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 (7508P), 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 code 111), e.g., agricultural
workers; greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS code 112), e.g., cattle ranchers
and farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS code 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
Pesticide manufacturing (NAICS code 32532), e.g.,
agricultural workers; commercial applicators; farmers; greenhouse,
nursery, and floriculture workers; residential users.
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Access Electronic Copies of this Document?
In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at 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. You may also access a
frequently updated electronic version of 40 CFR part 180 through the
Government Printing
[[Page 41914]]
Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of the FFDCA, as amended by the Food Quality
Protection Act (FQPA), any person may file an objection to any aspect
of this regulation and may also request a hearing on those objections.
The EPA procedural regulations which govern the submission of
objections and requests for hearings appear in 40 CFR part 178. You
must file your objection or request a hearing on this regulation in
accordance with the instructions provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-
2004-0154 in the subject line on the first page of your submission. All
requests must be in writing, and must be mailed or delivered to the
Hearing Clerk on or before October 1, 2007.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2004-0154, by one of the following methods.
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is (703) 305-5805.
II. Background
A. What Action is the Agency Taking?
In the Federal Register of August 4, 2004 (69 FR 47051) (FRL-7368-
7), EPA issued a proposal to revoke, remove, modify, and establish
certain specific tolerances for residues of the insecticides
fenbutatin-oxide and hydramethylnon; the herbicides bromoxynil,
diclofop-methyl, paraquat, picloram, and triclopyr; the fumigant
phosphine; the fungicides etridiazole, folpet, and TPTH; the miticides
dicofol and propargite, and the plant growth regulator and herbicide
diquat. Also, the proposal of August 4, 2004 (69 FR 47051) (FRL-7368-7)
provided a 60-day comment period which invited public comment for
consideration and for support of tolerance retention under the FFDCA
standards. In the Federal Register of October 6, 2004 (69 FR 59843)
(FRL-7682-5), EPA extended the comment period from October 4, 2004 to
October 18, 2004.
In this final rule, EPA is revoking, removing, modifying, and
establishing specific tolerances for residues of bromoxynil, diclofop-
methyl, dicofol, diquat, etridiazole, fenbutatin-oxide, folpet,
hydramethylnon, paraquat, phosphine, picloram, propargite, TPTH, and
triclopyr in or on commodities listed in the regulatory text of this
document. However, while EPA also proposed on August 4, 2004 (69 FR
47051) to revoke and modify specific tolerances for iprodione, the
Agency is not taking any action on iprodione tolerances in this
document.
EPA is finalizing these tolerance actions in order to implement the
tolerance recommendations made during the reregistration and tolerance
reassessment processes (including follow-up on canceled or additional
uses of pesticides). As part of these processes, EPA is required to
determine whether each of the amended tolerances meets the safety
standard of the FFDCA. The safety finding determination of ``reasonable
certainty of no harm'' is discussed in detail in each Reregistration
Eligibility Decision (RED) and Report of the Food Quality Protection
Act (FQPA) Tolerance Reassessment Progress and Risk Management Decision
(TRED) for the active ingredient. REDs and TREDs recommend the
implementation of certain tolerance actions, including modifications,
to reflect current use patterns, to meet safety findings and change
commodity names and groupings in accordance with new EPA policy.
Printed copies of many REDs and TREDs may be obtained from EPA's
National Service Center for Environmental Publications (EPA/NSCEP),
P.O. Box 42419, Cincinnati, OH 45242-2419, telephone: 1-800-490-9198;
fax: 1-513-489-8695; internet at 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 Electronic copies of REDs and TREDs are available on the internet at http://www.regulations.gov. and
http:// www.epa.gov/pesticides/reregistration/status.htm.
In this final rule, EPA is revoking certain tolerances because
either they are no longer needed or are associated with food uses that
are no longer registered under FIFRA in the United States. Those
instances where registrations were canceled were because the registrant
failed to pay the required maintenance fee and/or the registrant
voluntarily requested cancellation of one or more registered uses of
the pesticide active ingredient. The tolerances revoked by this final
rule are no longer necessary to cover residues of the relevant
pesticides in or on domestically treated commodities or commodities
treated outside but imported into the United States. It is EPA's
general practice to issue a final rule revoking those tolerances and
tolerance exemptions for residues of pesticide active ingredients on
crop uses for which there are no active registrations under FIFRA,
unless any person in comments on the proposal indicates a need for the
tolerance or tolerance exemption to cover residues in or on imported
commodities or domestic commodities legally treated.
EPA has historically 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.
Generally, EPA will proceed with the revocation of these tolerances
on the grounds discussed in this Unit if one of the following
conditions applies:
1. Prior to EPA's issuance of a section 408(f) order requesting
additional data or issuance of a section 408(d) or (e) order revoking
the tolerances on other grounds, commenters retract the comment
identifying a need for the tolerance to be retained.
2. EPA independently verifies that the tolerance is no longer
needed.
3. The tolerance is not supported by data that demonstrate that the
tolerance meets the requirements under FQPA.
This final rule does not revoke those tolerances for which EPA
received comments stating a need for the tolerance to be retained. In
response to the proposal published in the Federal Register of August 4,
2004 (69 FR 47051) (FRL-7368-7), EPA received comments during the 60-
day public comment period, as follows:
1. General--comment by private citizen. A comment was received from
a private citizen on August 15, 2004
[[Page 41915]]
which expressed a general concern for chemicals and their toxic
effects. In addition, the private citizen stated ``I oppose and object
to the use/approval/sale of this product'' in reference to bromoxynil
and diclofop methyl. Also, the individual stated opposition to
increasing any tolerances due to a concern about the sale of more
product.
Agency response. Section 408(g) of the FFDCA, 21 U.S.C. 346a(g) and
the implementing regulations at 40 CFR part 178, establish procedures
for formally challenging EPA rulemakings establishing tolerances or
exemptions from tolerances. This formal challenge is initiated through
the filing of ``objections'' with EPA. The procedures for filing
objections are summarized in this final rule under the section titled
``Objections and Hearing Requests.'' As is made clear in that section,
all objections must be in writing, and must be mailed or delivered to
EPA's Hearing Clerk within 60 days of the publication of the final
rule.
Because the communication of August 15, 2004 was sent to the public
docket of the proposed rule, EPA concludes that the communication does
not intend to initiate the formal procedures for objecting under 40 CFR
part 178 to the tolerance actions made herein. The communication from
the private citizen from New Jersey is considered by EPA to be a
``comment'' rather than an ``objection.'' In order to file an
objection, one must follow the procedures as explained in the previous
paragraph and set forth in 40 CFR part 178.
The comment of August 15, 2004 did not refer to any specific
scientific studies which supported the reregistration of any active
ingredient, or Agency decision document which supported or addressed
the reregistration eligibility of any active ingredient.
Section 4 of FIFRA directs EPA to make decisions about the future
use of older pesticides. Under the pesticide reregistration program,
EPA examines health and safety data for pesticide active ingredients
initially registered before November 1, 1984, and determines whether
they are eligible for reregistration to ensure that they meet current
scientific and regulatory standards. During reregistration, EPA
considers the human health and ecological effects of pesticides and
addresses actions to reduce risks that are of concern.
Of 612 cases subject to reregistration, about 40% have been
canceled for various reasons, including request for voluntary
cancellation by the registrant, cancellation by EPA because required
fees were not paid, or cancellation by EPA because unacceptable risk
existed that could not be reduced by other actions such as voluntary
cancellation of selected uses or changes in the way the pesticide is
used.
Reducing pesticide risks is an important aspect of the
reregistration program. In developing REDs, EPA works with stakeholders
including pesticide registrants, growers and other pesticide users,
environmental and public health interests, as well as the States, U.S.
Department of Agriculture (USDA), and other Federal agencies, and
others to develop voluntary measures or regulatory controls needed to
effectively reduce risks of concern. Such options include voluntary
cancellation of pesticide products or deletion of uses, declaring
certain uses ineligible or not yet eligible, restricting use of
products to certified applicators, limiting the amount or frequency of
use, improving use directions and precautions, adding more protective
clothing and equipment requirements, requiring special packaging or
engineering controls, requiring no-treatment buffer zones, employing
environmental and ecological safeguards, and other measures.
Also, for all pesticides with food uses, EPA is reassessing
tolerances (pesticide residue limits in food) to ensure that they met
the safety standard of section 408 of the FFDCA, 21 U.S.C. 346a, as
amended by the FQPA of 1996. Under FFDCA, EPA must make a determination
that pesticide residues remaining in or on food are safe; that is, that
there is reasonable certainty that no harm will result from aggregate
exposure to the pesticide residue from dietary and other sources. EPA
has integrated reregistration and tolerance reassessment to most
effectively accomplish the goals of both programs.
At the end of the reregistration process, after EPA has issued a
RED and declared a pesticide reregistration case eligible for
reregistration, individual end-use products that contain pesticide
active ingredients included in the case still must be reregistered.
During this product reregistration, EPA sends registrants a DCI notice
requesting any product specific data and specific revised labeling
needed to complete reregistration for each of the individual pesticide
products covered by the RED. Based on the results of EPA's review of
these data and labeling, products found to meet FIFRA and FFDCA
standards may be reregistered.
2. Bromoxynil--comment by the People's Republic of China (PRC).
After the public comment period extension had ended on October 18,
2004, EPA received comment from the PRC, forwarded by the U.S.
Department of Commerce's National Institute of Standards and
Technology, on November 3, 2004. The PRC asked for information
concerning Good Agricultural Practice (GAP) basis data for the use of
bromoxynil on garlic and onion.
Agency response. The Agency proposed no action on the existing
tolerances in 40 CFR 180.324 for bromoxynil on garlic or onion, dry
bulb. Information on study data which support the bromoxynil RED are
available in the OPP public docket for the proposed rule of August 4,
2004 (69 FR 47051), OPP-2004-0154, and on the reregistration status
website at http://www.epa.gov/pesticides/reregistration/status.htm. The
crop field trial references for garlic are MRIDs 42331002 and 42540602,
and for onion, dry bulb are MRIDs 42350701 and 42747601. The bromoxynil
residues of concern on garlic and onion, dry bulb were below the limit
of quantitation (LOQ) of 0.02 parts per million (ppm), which support
their current tolerance levels at 0.1 ppm.
Because flax straw is no longer a regulated feed item, the
tolerance for bromoxynil residue is no longer needed. Therefore, EPA is
revoking the tolerance in 40 CFR 180.324(a)(1) for ``flax, straw.''
Also, EPA is removing the commodity tolerances in 40 CFR 180.324(a)(1)
for residues of bromoxynil in or on ``corn, stover'' which was
previously termed corn, fodder (dry) in the RED; ``corn, fodder
(green);'' and ``corn, grain'' because these tolerances are no longer
needed since their uses are covered by the existing tolerances for
corn, field, stover and corn, grain, field. Further, based on field
trial data that indicate residues of bromoxynil as high as 0.14 ppm in
or on corn stover, the Agency determined that the tolerance for corn,
field, stover should be increased to 0.2 ppm and a tolerance should be
established for corn, pop, stover at 0.2 ppm. Therefore, EPA is
increasing the tolerance in 40 CFR 180.324(a)(1) on ``corn, field,
stover'' from 0.1 ppm to 0.2 ppm and establishing a tolerance for
residues of bromoxynil in or on ``corn, pop, stover'' at 0.2 ppm.
Since the proposal of August 4, 2004 (69 FR 47051), EPA published a
final rule in the Federal Register on February 10, 2005 (70 FR 7044)
(FRL-7690-6) that removed expired time-limited tolerances for emergency
exemptions, including those for bromoxynil on timothy, hay and timothy,
forage in 40 CFR 180.324(b) and reserved that section.
[[Page 41916]]
Based on field trial data that indicate residues of bromoxynil in
or on alfalfa hay as high as 0.38 ppm and to conform tolerance
nomenclature to current Agency practice, the Agency determined that the
tolerance for alfalfa, seedling should be revised into alfalfa, forage
and alfalfa, hay, and the tolerance on alfalfa, hay should be increased
to 0.5 ppm. Therefore, EPA is revising the commodity tolerance
``alfalfa, seedling'' (shown in paragraph (a)(1) as alfalfa, seeding)
in 40 CFR 180.324(a)(1) at 0.1 ppm to ``alfalfa, forage,'' and
``alfalfa, hay'' and maintaining the tolerance on alfalfa, forage at
0.1 ppm, while increasing the tolerance on alfalfa, hay to 0.5 ppm.
Based on field trial data that indicate residues of bromoxynil in
or on grass forage and hay as high as 2.9 ppm and 2.4 ppm,
respectively, the Agency determined that the tolerances for grass
forage and hay should be increased to 3.0 ppm. Therefore, EPA is
revising the commodity terminologies ``canarygrass, annual, seed'' and
``canarygrass, annual, hay'' (formerly grass, canary, annual, straw) in
40 CFR 180.324(a)(1) to ``grass, forage'' and ``grass, hay,''
respectively, and increasing each of their tolerances from 0.1 ppm to
3.0 ppm.
Based on field trial data that indicate residues of bromoxynil in
or on barley straw as high as 3.9 ppm, and translating barley data to
oat straw, the Agency determined that the tolerances for barley straw
and oat straw should be increased to 4.0 ppm. Therefore, EPA is
increasing the tolerances in 40 CFR 180.324(a)(1) for residues of
bromoxynil in or on ``barley, straw'' from 0.1 ppm to 4.0 ppm, and
``oat, straw'' from 0.1 ppm to 4.0 ppm.
Based on field trial data that indicate residues of bromoxynil in
or on wheat forage and straw as high as 0.6 ppm and 1.2 ppm,
respectively, and translating wheat data to rye, the Agency determined
that the tolerances for both rye and wheat forage should be increased
to 1.0 ppm, and both rye and wheat straw should be increased to 2.0
ppm. Therefore, EPA is increasing the tolerances in 40 CFR
180.324(a)(1) for residues of bromoxynil in or on ``rye, forage'' from
0.1 ppm to 1.0 ppm; ``rye, straw'' from 0.1 ppm to 2.0 ppm; ``wheat,
forage'' from 0.1 ppm to 1.0 ppm; and ``wheat, straw'' from 0.1 ppm to
2.0 ppm.
Based on field trial data that indicate residues of bromoxynil in
or on barley forage, and translating barley data to oat, the Agency
determined that the tolerance for oat forage should be increased to 0.3
ppm. Therefore, EPA is increasing the tolerance in 40 CFR 180.324(a)(1)
for residues of bromoxynil in or on ``oat, forage'' from 0.1 ppm to 0.3
ppm.
Based on field trial data that indicate residues of bromoxynil in
or on sorghum forage and stover as high as 0.29 and 0.14 ppm,
respectively, the Agency determined that the tolerances for sorghum
forage and stover should be increased to 0.5 ppm and 0.2 ppm,
respectively. Therefore, EPA is increasing the tolerances in 40 CFR
180.324(a)(1) for residues of bromoxynil in or on ``sorghum, forage''
from 0.1 ppm to 0.5 ppm and revising the commodity terminology to
``sorghum, grain, forage;''and ``sorghum, grain, stover'' from 0.1 ppm
to 0.2 ppm. The Agency determined that the increased tolerances are
safe; i.e., there is a reasonable certainty that no harm will result
from aggregate exposure to the pesticide chemical residue.
Based on field trial data that indicate residues of bromoxynil in
or on grain of barley, corn, sorghum, and wheat at < 0.02 ppm and
translating barley data to oat grain and rye grain, the Agency
determined that the grain tolerances for barley; field corn; oat; rye;
sorghum; and wheat should be decreased to 0.05 ppm and a tolerance
should be established for corn, pop, grain at 0.05 ppm. Therefore, EPA
is decreasing the tolerances in 40 CFR 180.324(a)(1) from 0.1 ppm to
0.05 ppm, for the following: ``barley, grain;'' ``oat, grain;'' ``rye,
grain;'' ``sorghum, grain;'' ``wheat, grain;'' and ``corn, grain,
field;'' and also revising the terminolgy for ``corn, grain, field'' to
read ``corn, field, grain.'' Also in 40 CFR 180.324(a)(1), EPA is
establishing a tolerance for residues of bromoxynil in or on ``corn,
pop, grain'' at 0.05 ppm.
Because residues of bromoxynil are detectable in aspirated grain
fractions of wheat (highest), corn, and sorghum, the Agency determined
that a tolerance on the aspirated fractions of grain should be
established at 0.3 ppm. Therefore, EPA is establishing a tolerance in
40 CFR 180.324(a)(1) for residues of bromoxynil in or on ``grain,
aspirated fractions'' at 0.3 ppm.
Based on residue data for hay of wheat and barley that indicate
residues of bromoxynil as high as 3.2 ppm for wheat, but not exceeding
9.0 ppm for barley, and translating barley data to oat hay, the Agency
determined that tolerances should be established for wheat hay at 4.0
ppm, barley hay at 9.0 ppm, and oat, hay at 9.0 ppm. Therefore, EPA is
establishing tolerances in 40 CFR 180.324(a)(1) for residues of
bromoxynil in or on ``barley, hay'' at 9.0 ppm, ``oat, hay'' at 9.0
ppm, and ``wheat, hay'' at 4.0 ppm.
The 1998 Bromoxynil RED recommended that the tolerance for corn,
forage, field (green) be revised to corn, field, forage and increased
from 0.1 ppm to 0.3 ppm based on residue data for corn forage. However,
at that time, no tolerance for corn, forage, field (green) existed in
40 CFR 180.324(a)(1). Therefore, EPA is establishing a tolerance in 40
CFR 180.324(a)(1) for ``corn, field, forage'' at 0.3 ppm.
In addition, EPA is revising commodity terminology in 40 CFR
180.324 to conform to current Agency practice as follows: ``mint hay''
to ``peppermint, hay'' and ``spearmint, hay.''
The Agency did not propose in a notice for comment to revise the
tolerance nomenclature for bromoxynil in 40 CFR 180.324(a)(1) from
onion, dry bulb to onion, bulb, as is current Agency practice. However,
section 553(b)(3)(B) of the Administrative Procedure Act provides that
notice and comment is not necessary ``when the agency for good cause
finds (and incorporates the finding and a brief statement of reasons
therefore in the rules issued) that notice and public procedure thereon
are impracticable, unnecessary, or contrary to the public interest.''
Consequently, for good cause, EPA is revising the tolerance in 40 CFR
180.324(a)(1) from onion, dry bulb to onion, bulb. The reason for
taking this action is because such action has no practical impact on
the use of or exposure to the pesticide active ingredient, bromoxynil,
in or on that commodity and is made such that the tolerance terminology
will conform to current Agency practice.
3. Dicofol--comment by the PRC. After the public comment period
extension had ended on October 18, 2004, EPA received comment from the
PRC, forwarded by the U.S. Department of Commerce's National Institute
of Standards and Technology, on November 3, 2004. The PRC expressed
concern that the GAP alone is insufficient as the basis for EPA's
determination for proposing to establish a tolerance for dicofol
residues in milk at 22.0 ppm in the absence of risk assessment support.
Also, the PRC was concerned about EPA's proposal to reduce the
tolerances for residues of dicofol on nuts from 5.0 ppm to 0.1 ppm and
the Agency's determination to translate data from pecan field trials to
other nuts such as chestnut and walnut. In addition, the PRC cited nut
tolerance levels for dicofol of 3.0 ppm in Canada, 1.0 ppm in Korea,
and 5.0 ppm for almond in Australia.
Agency response. EPA is redesignating the dicofol tolerance
[[Page 41917]]
expression for plant commodities in 40 CFR 180.163(a) to (a)(1),
separately from the animal tolerances, and to revise the expression in
terms of the combined residues of 1,1-bis(4-chlorophenyl)-2,2,2-
trichloroethanol and 1-(2-chlorophenyl)-1-(4-chlorophenyl)-2,2,2-
trichloroethanol. Because dicofol metabolites are the residues of
concern for animals, EPA is proposing to redesignate animal tolerances
separately from plant tolerances, from 40 CFR 180.163(a) to (a)(2) and
for tolerances to be expressed in terms of the combined residues of
1,1-bis(4-chlorophenyl)-2,2,2-trichloroethanol and its metabolites, 1-
(2-chlorophenyl)-1-(4-chlorophenyl)-2,2,2-trichloroethanol, 1,1-bis(4-
chlorophenyl)-2,2-dichloroethanol, and 1-2(-chlorophenyl)-1-(4-
chlorophenyl)-2,2-dichloroethanol.
As stated in the proposal of August 4, 2004 (69 FR 47051), based on
ruminant metabolism and feeding data, the Agency determined that the
tolerance for milk should reflect dicofol residues of 0.75 ppm in whole
milk corrected by a factor of 30x to account for concentration in milk
fat from whole milk such that 22.0 ppm is appropriate (tolerance is
based on milk fat). However, the Agency acknowledges that on August 4,
2004 (69 FR 47051) it proposed to establish a tolerance for ``milk'' as
shown in the dicofol RED, but that the appropriate definition for the
tolerance commodity should be termed ``milk, fat (reflecting 0.75 ppm
in whole milk).'' The appropriate level for that tolerance definition
is 22.0 ppm. Therefore, EPA is establishing a tolerance in 40 CFR
180.163(a)(2) for milk, fat (reflecting 0.75 ppm in whole milk) at 22.0
ppm.
The Agency proposed reducing the nut tolerances based on both pecan
and walnut field trials that showed residues of dicofol were non-
detectable and determined that 0.1 ppm is appropriate. Pecan, chestnut,
and walnut are among commodities included in 40 CFR 180.41 under the
tree nut crop group 14. The Agency considers pecans and almonds as
representative commodities for that crop group. The Agency determined
that the data translated to other nuts and that the tolerances for
butternut, chestnut, filbert, hickory nut, macadamia nut, pecan, and
walnut should be at 0.1 ppm. The Agency notes that there is a Codex
maximum residue limit (MRL) for dicofol residues on pecan at 0.01 ppm
which is at or above the limit of detection. Both the Codex MRL on
pecan and proposed U.S. tolerance for nuts are lower than the MRLs
cited by the PRC. Different MRLs among countries for a specific
pesticide residue on a given commodity may be due to use patterns
reflecting different pest and disease pressures. Therefore, EPA is
decreasing the tolerances in 40 CFR 180.163(a)(1) on ``nut, macadamia''
from 5 ppm to 0.1 ppm;'' ``butternut'' from 5 ppm to 0.1 ppm,
``chestnut'' from 5 ppm to 0.1 ppm, ``filbert'' from 5 ppm to 0.1 ppm,
``nut, hickory'' from 5 ppm to 0.1 ppm, ``pecan'' from 5 ppm to 0.1
ppm, and ``walnut'' from 5 ppm to 0.1 ppm, all based on available data.
EPA is revoking the commodity tolerances in 40 CFR 180.163(a)(1)
for residues of dicofol in or on ``fig'' because the registration for
that use was canceled in October 1989 due to non-payment of annual
registration maintenance fees. Also, EPA is removing ``hazelnuts''
because this tolerance is covered by the tolerance on filbert. The
Agency did not propose in a notice for comment to revise the tolerance
nomenclature for dicofol in 40 CFR 180.163(a)(1) from filbert to
hazelnut, as is current Agency practice. However, section 553(b)(3)(B)
of the Administrative Procedure Act provides that notice and comment is
not necessary ``when the agency for good cause finds (and incorporates
the findings and a brief statement of the reasons therefore in the
rules issued) that notice and public procedure thereon are
impracticable, unnecessary, or contrary to the public interest.''
Consequently, for good cause, EPA is revising the tolerance terminology
in 40 CFR 180.163(a)(1) from filbert to hazelnut. The reason for taking
this action is because such action has no practical impact on the use
of or exposure to the pesticide active ingredient, dicofol, in or on
that commodity and is made such that the tolerance terminology will
conform to current Agency practice. In addition, the tolerance on
``hay, spearmint'' in 40 CFR 180.163(a) was removed on June 29, 2007
(72 FR 35663) (FRL-8131-3).
Based on field trial data that indicate residues of dicofol were as
high as 6.7 ppm in or on apples and in one duplicate sample 10.8 ppm in
or on pears (6.8 ppm in pears for the other duplicate sample), the
Agency determined that a crop group tolerance of 10.0 ppm is
appropriate. Therefore, EPA is combining the commodity tolerances for
``apple,'' ``crabapple,'' ``pear,'' and ``quince,'' each at 5 ppm in 40
CFR 180.163(a)(1) under the crop group terminology ``fruit, pome, group
11'' and increasing the tolerance to 10.0 ppm.
Based on field trial data that indicate residues of dicofol were as
high as 0.84 ppm in or on plums, 3.08 ppm in or on cherries, and 3.79
ppm in or on peaches, the Agency determined that a crop group tolerance
of 5.0 ppm is appropriate. Therefore, EPA is combining the commodity
tolerances for ``apricot'' at 10 ppm; ``cherry'' at 5 ppm,
``nectarine'' at 10 ppm, ``peach'' at 10 ppm, and ``plum, prune,
fresh'' at 5 ppm, in 40 CFR 180.163(a)(1) under the crop group
terminology ``fruit, stone, group 12'' and decreasing the tolerance to
5.0 ppm.
EPA is combining the commodity tolerances for ``blackberry,''
``boysenberry,'' ``dewberry,'' ``loganberry,'' and ``raspberry,'' each
at 5 ppm in 40 CFR 180.163(a)(1) under the crop subgroup terminology
``caneberry subgroup 13A'' and maintaining the tolerance at 5 ppm,
based on new field trials.
Based on field trial data that indicate residues of dicofol were as
high as 0.35 ppm in or on melons, 0.45 ppm in or on cucumbers, and 1.05
ppm in or on summer squash, the Agency determined that a crop group
tolerance of 2.0 ppm is appropriate. Therefore, EPA is combining the
commodity tolerances for ``cantaloupe,'' ``cucumber,'' ``melon,''
``muskmelon,'' ``pumpkin,'' ``squash, summer;'' ``squash, winter;'' and
``watermelon,'' each at 5 ppm in 40 CFR 180.163(a)(1) under the crop
group terminology ``vegetable, cucurbit, group 9'' and decreasing the
tolerance to 2.0 ppm.
Based on field trial data that show that residues of dicofol were
as high as 1.34 ppm in or on lemon, 3.55 ppm in or on oranges, and 5.26
ppm in or on grapefruit, the Agency determined that a crop group
tolerance of 6.0 ppm is appropriate. Therefore, EPA is combining the
commodity tolerances for ``grapefruit,'' ``kumquat,'' ``lemon,''
``lime,'' ``orange, sweet'' and ``tangerine'' in 40 CFR 180.163(a)(1),
each at 10 ppm, under the commodity terminology ``fruit, citrus, group
10'' and decreasing the tolerance to 6.0 ppm.
Based on field trial data that indicate residues of dicofol were as
high as 0.46 ppm in or on tomatoes and 1.15 ppm in or on peppers, the
Agency determined that a crop group tolerance of 2.0 ppm is
appropriate. Therefore, EPA is combining the commodity tolerances for
``eggplant,'' ``pepper,'' ``pimento,'' and ``tomato'' in 40 CFR
180.163(a)(1), each at 5 ppm, under the crop group terminology
``vegetable, fruiting, group 8'' and decreasing the tolerance to 2.0
ppm, based on new field trials.
Based on field trial data that indicate residues of dicofol as high
as 0.46 ppm in or on dry beans and 2.09 ppm in or on succulent beans,
the Agency has determined that the appropriate tolerances are 0.5 ppm
for dry beans and
[[Page 41918]]
3.0 ppm for succulent beans. Therefore, EPA is decreasing the
tolerances in 40 CFR 180.163(a)(1) on ``bean, dry, seed'' from 5.0 ppm
to 0.5 ppm, and combining ``bean, snap, succulent'' and ``bean, lima,
succulent'' into ``bean, succulent'' and decreasing the tolerance from
5.0 ppm to 3.0 ppm.
Based on field trial data that indicate residues of dicofol as high
as 64.3 ppm on dried hops, the Agency has determined that the tolerance
should be for dried hops at 65.0 ppm. Therefore, EPA is increasing the
tolerance in 40 CFR 180.163(a)(1) for ``hop'' from 30 ppm to 65.0 ppm
and revising the commodity tolerance to ``hop, dried cones'' because
the raw agricultural commodity (RAC) is redefined. The Agency
determined that the increased tolerance is safe; i.e., there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue.
Because available data show that residues of dicofol were as high
as 9.8 ppm on strawberries, the Agency determined that the tolerance
should be at 10.0 ppm. Therefore, EPA is increasing the tolerance in 40
CFR 180.163(a)(1) for ``strawberry'' from 5 ppm to 10.0 ppm. The Agency
determined that the increased tolerance is safe; i.e., there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue.
Based on highest average field trial (HAFT) residues of 5.54 ppm on
apples, 3.16 ppm on oranges, 0.06 ppm on cotton, 3.02 ppm on grapes,
17.6 ppm on mint, 29.1 ppm on plucked tea leaves, and available
processing data showing average concentration factors of 6.6x in wet
apple pomace, 3.7x in dried orange pulp, 62.8x in orange oil, 4.9x in
refined cotton oil, 6.6x in raisins, 1.6x in mint oil, and 1.6x in
dried tea, the Agency determined that tolerances for dicofol are
warranted as follows: wet apple pomace at 38 ppm, dried citrus pulp at
12 ppm, citrus oil at 200 ppm, refined cotton oil at 0.5 ppm, raisins
at 20.0 ppm, peppermint oil at 30 ppm, spearmint oil at 30 ppm, tea,
plucked tea leaves at 30.0 ppm, and dried tea at 50 ppm. Therefore, EPA
is increasing the tolerance in 40 CFR 180.163(a)(1) for ``tea, dried''
from 45 ppm to 50.0 ppm and establishing tolerances in 40 CFR 180.163
(a)(1) for ``apple, wet pomace'' at 38.0 ppm, ``citrus, dried pulp'' at
12.0 ppm, ``citrus, oil'' at 200.0 ppm, ``cotton, refined oil'' at 0.5
ppm, ``grape, raisin'' at 20.0 ppm, ``peppermint, oil'' at 30.0 ppm,
``spearmint, oil'' at 30.0 ppm, and ``tea, plucked leaves'' at 30.0
ppm.
In the dicofol RED, the Agency recommended the establishment of a
tolerance on prunes (currently termed plum, prune, dried) at 3.0 ppm.
However, a new tolerance for the processed commodity prunes as ``plum,
prune, dried'' at 3.0 ppm is not needed because that use is covered by
the combination of stone fruits into a group tolerance at 5.0 ppm, as
described above.
Based on hen metabolism and feeding data, and residues in
cottonseed meal (20% diet X 0.1 ppm residue), the Agency has determined
that tolerances should be established at 0.1 ppm for poultry fat, meat,
and meat byproducts. The tolerance for eggs should be decreased to 0.05
ppm for compatibility with Codex. Therefore, EPA is establishing
tolerances in 40 CFR 180.163(a)(2) for ``poultry, fat;'' ``poultry,
meat;'' and ``poultry, meat byproducts;'' each at 0.1 ppm and ``egg''
at 0.05 ppm.
Based on ruminant metabolism and feeding data, the Agency
determined that tolerances for fat of cattle, goats, hogs, horses and
sheep should be established at 50.0 ppm; meat and meat byproducts,
except liver of cattle, goats, hogs, horses and sheep should be
established at 3.0 ppm; and liver of cattle, goats, hogs, horses and
sheep should be established at 5.0 ppm. Therefore, EPA is establishing
tolerances in 40 CFR 180.163(a)(2) for the following: ``cattle, meat;''
``cattle, meat byproducts, except liver;'' ``goat, meat;'' ``goat, meat
byproducts, except liver;'' ``hog, meat;'' ``hog, meat byproducts,
except liver;'' ``horse, meat;'' ``horse, meat byproducts, except
liver;'' ``sheep, meat;'' and ``sheep, meat byproducts, except liver;''
each at 3.0 ppm; ``cattle, liver;'' ``goat, liver;'' ``hog, liver;''
``horse, liver;'' and ``sheep, liver;'' each at 5.0 ppm; and ``cattle,
fat;'' ``goat, fat;'' ``hog, fat;'' ``horse, fat;'' and ``sheep, fat;''
each at 50.0 ppm.
EPA is revising commodity terminology in 40 CFR 180.163 to conform
to current Agency practice as follows: ``hay, peppermint'' to
``peppermint, hay.''
4. Iprodione. EPA will not take action on iprodione tolerances at
this time based on comments and additional submitted data. EPA will
respond to comments about iprodione that were received during the
public comment period and address iprodione tolerance actions in a
future notice to be published in the Federal Register.
5. Paraquat--comment by Syngenta Crop Protection. On September 9,
2004, Syngenta Crop Protection Inc. requested that the Agency consider
the inclusion of commodities from berries group 13 in its proposed
revision of the small fruit group tolerance for paraquat into
individual tolerances for cranberry and grape. Syngenta stated that
berry data was submitted years ago and berry uses appear on active
registrations for paraquat dichloride.
Agency response. EPA proposed to revise the crop group tolerance
for small fruit but inadvertently proposed to revise that group into
individual tolerances only for cranberry and grape, and maintain these
tolerances at 0.05 ppm. However, the old terminology of ``small fruit''
not only includes cranberry and grape, but also blackberry, blueberry,
boysenberry, currant, dewberry, elderberry, gooseberry, huckleberry,
loganberry, raspberry, strawberry, and youngberry. In 40 CFR 180.41,
berry group 13 includes blackberry (blackberry includes boysenberry,
dewberry, and youngberry), blueberry, currant, elderberry, gooseberry,
huckleberry, loganberry, and raspberry. Consequently, revising small
fruit into the individual tolerances for cranberry, grape, and
strawberry, as well as maintaining a tolerance on berry group 13, would
cover the commodity uses under the old terminology of small fruit. The
Agency agrees with Syngenta that berry uses have active registrations.
Some tolerance actions proposed for paraquat on August 4, 2004 (69 FR
47051) have already been made final or revised to different tolerance
levels in a final rule published in the Federal Register on September
6, 2006 (71 FR 52487)(FRL-8089-3), where EPA established and revised
certain tolerances in 40 CFR 180.205 on paraquat in response to
multiple petition requests by Syngenta Crop Protection Inc. In the
final rule of September 6, 2006 (71 FR 52487), EPA established
tolerances in 40 CFR 180.205 at 0.05 ppm on berry group 13, cranberry,
and grape. A tolerance already existed on strawberry at 0.25 ppm.
However, the tolerance on the obsolete commodity terminology ``fruit,
small'' was inadvertently not revoked and currently remains as a
duplicate tolerance that is no longer needed and should be revoked.
Consequently, EPA is following up on the proposed rule of August 4,
2004 (69 FR 47051), which included a proposal to remove the small fruit
tolerance in 40 CFR 180.205(a) by proposing to revise that crop group
tolerance (an obsolete nomenclature) into multiple tolerance
definitions that would cover commodity uses previously associated with
small fruit. Because multiple tolerances (berry group 13, cranberry,
grape, and strawberry) have
[[Page 41919]]
been established to cover the small fruit uses, EPA is following-up by
revoking the tolerance in 40 CFR 180.205(a) on fruit, small in this
final rule.
Other tolerance actions proposed on August 4, 2004 (69 FR 47051)
have also been made final or revised to different tolerance levels. In
the final rule of September 6, 2006 (71 FR 52487), EPA increased the
tolerances in 40 CFR 180.205(a) on kidney of cattle, goats, hogs,
horses, and sheep, each from 0.3 ppm to 0.5 ppm, which harmonize with
Codex MRLs; hop, dried cones from 0.2 ppm to 0.5 ppm; sorghum, forage,
forage and sorghum, grain, forage from 0.05 ppm to 0.1 ppm; soybean,
forage from 0.05 ppm to 0.4 ppm; decreased the tolerance in 40 CFR
180.205(a) on ``beet, sugar, tops'' from 0.5 ppm to 0.05 ppm; and
established tolerances in 40 CFR 180.205(a) for soybean hay at 10.0
ppm, soybean hulls at 4.5 ppm; and soybean seed at 0.7 ppm; fruit,
pome, group 11 at 0.05 ppm; fruit, stone, group 12 at 0.05 ppm; barley,
straw at 1.0 ppm; wheat, forage at 0.5 ppm; and wheat, straw at 50.0
ppm.
In the final rule of September 6, 2006 (71 FR 52487), the Agency
inadvertently did not revoke the individual tolerances in 40 CFR
180.205 at 0.05 ppm on apple and pear when it established the fruit,
pome, group 11 tolerance at 0.05 ppm; the individual tolerances at 0.05
ppm on apricot, cherry, nectarine, peach, and plum, prune, fresh when
it established the fruit, stone, group 12 tolerance at 0.05 ppm; and
the individual tolerances at 0.05 ppm on broccoli, cabbage, Chinese
cabbage, cauliflower, and collards when it established the vegetable,
brassica, leafy, group 5 tolerance at 0.05 ppm. Also, in the Federal
Register of December 6, 2006 (71 FR 70670) (FRL-8100-3), EPA corrected
a typographical error in the codification section on page 52494 of the
final rule of September 6, 2006 (71 FR 52487) regarding the commodity
terminology name ``fruit, stone, group 12.'' The notice of August 4,
2004 (69 FR 47051) proposed to combine specific individual tolerances
into their respective crop groups (including fruit, pome, group 11,
fruit, stone, group 12, and vegetable, brassica, leafy, group 5), with
the effect of removing those specific individual tolerances since their
uses were to be covered by the group tolerances. Because these group
tolerances were established, their respective individual tolerances are
no longer needed. Consequently, EPA is following-up on the proposed
rule of August 4, 2004 (69 FR 47051), which included proposals to
combine specific existing tolerances into group tolerances for fruit,
pome, group 11, fruit, stone, group 12, and vegetable, brassica, leafy,
group 5; and thereby remove those individual tolerances. Because these
group tolerances have been established, EPA is following-up by revoking
the tolerances in 40 CFR 180.205 on apple; pear; apricot; cherry;
nectarine; peach; plum, prune, fresh; broccoli; cabbage; cabbage,
chinese; cauliflower; and collards in this final rule. In addition, EPA
is correcting the commodity terminology in 40 CFR 180.205 for the group
5 tolerance from vegetable, Brassica leafy, group 5 to vegetable,
brassica, leafy, group 5, which was the group name proposed on August
4, 2004 (69 FR 47051).
Also, in the final rule of September 6, 2006 (71 FR 52487), EPA
inadvertently did not revoke the individual tolerances in 40 CFR
180.205 at 5.0 ppm on alfalfa, birdsfoot trefoil, and clover, when it
established the animal feed, nongrass, group 18, forage and animal
feed, nongrass, group 18, hay tolerances at 75.0 ppm and 210.0 ppm,
respectively. These individual tolerances are no longer needed.
Consequently, EPA is following up on the proposed rule of August 4,
2004 (69 FR 47051), which included proposals to increase the tolerances
for alfalfa forage, birdsfoot trefoil forage, and clover forage from
5.0 ppm to 75.0 ppm and combine them under the terminology animal feed,
nongrass, group 18, forage and increase alfalfa hay, birdsfoot trefoil
hay, and clover hay from 5.0 ppm to 210.0 ppm and combine them under
the terminology animal feed, nongrass, group 18, hay. Because these
group tolerances have been established, EPA is following-up by revoking
the individual tolerances in 40 CFR 180.205(a) on alfalfa, birdsfoot
trefoil, and clover.
In addition, in the final rule of September 6, 2006 (71 FR 52487),
EPA inadvertently established a tolerance in 40 CFR 180.205 on soybean,
seed at 0.7 ppm, but should have revised the existing tolerance on
soybean to soybean, seed (a nomenclature change that is current Agency
practice) and increased it from 0.05 ppm to 0.7 ppm (based on a new use
pattern in the petition) to avoid creating a duplicate tolerance.
Consequently, there now exists a duplicate tolerance; i.e., soybean at
0.05 ppm, which EPA proposed to increase in the rule of August 4, 2004
(69 FR 47051). That duplicate tolerance is not needed since the use on
soybean should be covered by the established soybean, seed tolerance at
the appropriate level of 0.7 ppm. Further, section 553(b)(3)(B) of the
Administrative Procedure Act provides that notice and comment is not
necessary ``when the agency for good cause finds (and incorporates the
finding and a brief statement of reasons therefore in the rules issued)
that notice and public procedure thereon are impracticable,
unnecessary, or contrary to the public interest.'' Consequently, for
good cause, while EPA is maintaining the tolerance on soybean, seed at
0.7 ppm, the Agency is revoking the tolerance on soybean at 0.05 ppm in
40 CFR 180.205(a). The reason for taking this action is because such
action has no practical impact on the use of or exposure to the
pesticide active ingredient, paraquat, in or on that commodity; i.e.,
the use is covered by the existing tolerance on soybean, seed at 0.7
ppm, which the Agency considers to be at the appropriate level.
Also, in the final rule of September 6, 2006 (71 FR 52487), EPA
inadvertently did not revoke the individual tolerances in 40 CFR
180.205 on bean, snap, succulent at 0.05 ppm, when it established the
tolerance on vegetable, legume, edible podded, subgroup 6A at 0.05 ppm;
bean, lima, succulent and pea, succulent, both at 0.05 ppm, when it
established the tolerance on pea and bean, succulent shelled, subgroup
6B at 0.05 ppm; and bean, dry, seed and pea, dry, seed, both at 0.3
ppm, when it established the tolerance on pea and bean, dried shelled,
except soybean, subgroup 6C, except guar bean. These established
subgroup tolerances cover the uses of the aforementioned individual
tolerances, which are no longer needed, and therefore, which should be
revoked. In order to provide notice and comment, the Agency intends to
address proposing the revocation of these individual tolerances in 40
CFR 180.205 for bean, snap, succulent; bean, lima, succulent; pea,
succulent; bean, dry, seed; and pea, dry, seed in a future publication
in the Federal Register.
Moreover, in the final rule of September 6, 2006 (71 FR 52487), EPA
established a tolerance in 40 CFR 180.205 on nut, tree, group 14 at
0.05 ppm, but should have revised the existing tolerance at 0.05 ppm on
nut to nut, tree, group 14 (a nomenclature change that is current
Agency practice). Also, EPA established a tolerance on vegetable,
cucurbit, group 9 at 0.05 ppm, but should have revised the existing
tolerance at 0.05 ppm on cucurbits to vegetable, cucurbit, group 9 (a
nomenclature change that is current Agency practice). Consequently,
since the uses are covered by other tolerances, the duplicate
tolerances on cucurbits and nut are no longer needed and should be
revoked. In order to provide notice and comment, the Agency intends to
address proposing the
[[Page 41920]]
revocation of the tolerances in 40 CFR 180.205(a) on cucurbits and nut
in a future publication in the Federal Register.
Finally, in the final rule of September 6, 2006 (71 FR 52487), EPA
established tolerances in 40 CFR 180.205 that were not proposed on
August 4, 2006. These include barley hay; cotton, gin byproducts;
ginger; grain, aspirated fractions; okra; and wheat hay; and increased
the tolerances on cotton, undelinted seed, onion, dry bulb (and revised
it to onion, bulb); and wheat grain.
EPA is revoking the tolerance in 40 CFR 180.205(a) on ``mint, hay,
spent'' because it is no longer recognized as a raw agricultural
commodity, and therefore the tolerance is no longer needed. Also, EPA
is removing the ``(N)'' designation from all entries to conform to
current Agency administrative practice (``N'' designation means
negligible residues), and revising the commodity terminology ``fruit,
citrus'' to ``fruit, citrus, group 10;'' and redefining the commodity
terminology for ``bean, forage'' to ``cowpea, forage'' and ``bean,
hay'' to ``cowpea, hay.'' However, EPA will not revoke the tolerance on
mint, hay in 40 CFR 180.205 because the Agency incorrectly based its
revocation in the paraquat RED on mint hay no longer being a raw
agricultural commodity. While ``mint hay'' is an obsolete commodity
terminology, it should be revised to peppermint, tops and spearmint,
tops, which EPA will address in a future publication in the Federal
Register.
Based on field trial data that indicate residues of paraquat as
high as 90 ppm in or on rangeland grass forage (which should be revised
to grass, forage) and 40 ppm in or on pasture grass hay (which should
be revised to grass, hay), the Agency determined that the tolerances
should be increased to 90 ppm for grass forage and 40 ppm for grass
hay. Therefore, EPA is revising the commodity terminologies in 40 CFR
180.205(a) for ``grass, pasture'' to ``grass, forage'' and increasing
the tolerance from 5 ppm to 90.0 ppm; and ``grass, range'' to ``grass,
hay'' and increasing the tolerance from 5 ppm to 40.0 ppm. The Agency
determined that the increased tolerances are safe; i.e., there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue.
Based on a reassessed pineapple tolerance of 0.05 ppm and pineapple
processing data that indicate an average concentration factor of 4.5x
in dried bran, the Agency determined that a tolerance should be
established for pineapple process residue (a wet-waste byproduct from
the fresh cut product line, which usually contains pineapple bran) at
0.25 ppm. Therefore, EPA is establishing a tolerance in 40 CFR
180.205(a) for ``pineapple, process residue'' at 0.25 ppm.
Based on a reassessed sugarcane tolerance of 0.5 ppm and sugarcane
processing data that indicate an average concentration factor of 5.5x
in blackstrap molasses, the Agency determined that a tolerance should
be established for sugarcane molasses at 3.0 ppm. Therefore, EPA is
establishing a tolerance in 40 CFR 180.205(a) for ``sugarcane,
molasses'' at 3.0 ppm.
On September 21, 2001 (66 FR 48593) (FRL-6799-2), EPA published a
final rule in the Federal Register which in 40 CFR 180.205(a)
established tolerances for ``corn, field, stover'' and ``corn, pop,
stover'' at 10.0 ppm; ``corn, field, grain'' and ``corn, pop, grain''
at 0.1 ppm; and ``corn, field, forage'' at 3.0 ppm; based on proposed
tolerances in petition 5F1625 submitted by Zeneca Ag. Products and to
harmonize corn, field, grain and corn, pop, grain with the Codex MRL of
0.1 ppm for maize. In the September 2001 final rule, EPA also stated
that in the food additive petition 5H5088, Zeneca had proposed a food
additive tolerance for ``corn flour'' at 0.1 ppm which was subsequently
withdrawn since EPA determined that the tolerance for corn, field,
grain at 0.1 ppm is adequate to cover residues in corn flour.
EPA is revising commodity terminologies in 40 CFR 180.205(a) from
``corn, fresh (inc. sweet corn), kernel plus cob with husks removed''
to ``corn, sweet, kernel plus cob with husks removed;'' and ``guar
bean'' to ``guar.''
In the proposed rule of August 4, 2004 (69 FR 47051)(FRL-7368-7),
EPA stated that peanut hay is no longer considered to be a significant
livestock feed commodity. In fact, peanut hay is considered by the
Agency to be a significant livestock feed item as shown at http://www.epa.gov/opptsfrs/OPPTS_Harmonized/860_Residue_Chemistry_Test_Guidelines/Series/
in the Residue Chemistry Test Guidelines OPPTS
860.1000 Table 1. Therefore, the Agency will not revoke the tolerance
but rather will maintain the tolerance level at 0.5 ppm in 40 CFR
180.205, which is consistent with the paraquat RED.
6. Propargite--comment by the PRC. After the public comment period
extension had ended on October 18, 2004, EPA received comment from the
PRC, forwarded by the U.S. Department of Commerce's National Institute
of Standards and Technology, on November 3, 2004. The PRC cited an
evaluation from a Joint FAO/WHO Meeting on Pesticide Residues (JMPR)
Evaluations of Pesticide Residues in Food for 2002, and stated that it
recommends a maximum limit of 100.0 ppm for residues of propargite on
dry hops and quoted a GAP data under U.S. supervision GAP (1.7
kilograms active ingredient/hectare (kg ai/ha) to the growing crop at
an interval of 14 days). Also, the PRC commented on the tolerance
levels for residues of propargite on garlic and nut, tree, group.
Agency response. Since the time of the proposed rule of August 4,
2004 (69 FR 47051), the Codex Alimentarius Commission adopted an MRL
for propargite on hops, dry at 100.0 milligrams/kilogram (mg/kg). The
2002 JMPR report cites a GAP for the United States with an application
rate as 1.8 kg ai/ha (about 1.6 lb active ingredient/acre (ai/A)) and
states that the meeting recommends a new maximum propargite residue
level for hops (dry) at 100.0 mg/kg (100.0 ppm). The JMPR report is
available at the website address http://www.fao.org/ag/agp/agpp/PesticidJMPR/JMPRreports.htm
.
In the Federal Register on December 13, 2006 (71 FR 74802) (FRL-
8064-3), the Agency finalized tolerance nomenclature changes including
a revision of ``hop, dried cone'' to ``hop, dried cones.'' Currently in
40 CFR 180.259, there are tolerances for propargite on both hop at 15.0
ppm and dried hops at 30.0 ppm. On August 4, 2004 (69 FR 47051), the
Agency proposed no action on the existing tolerance level for
propargite residues on hop, dried cones at 30.0 ppm, consistent with
the propargite RED. On September 22, 1992, Uniroyal submitted a hops
processing study for use of propargite treated hops in typical beer
brewing operations. Field trials on hops had used a wettable powder
formulation where the label calls for two applications of 1.5 lb ai/A
per year. Residues in dried hops did not exceed the existing tolerance
of 30.0 ppm following either two applications to hops at 0.9X (1.35 lb
ai/A) or three applications at 1.5X (2.25 lb ai/A), both with a PHI of
14 days. Hence, no change in the tolerance level for dried hops was
recommended by the Agency in the propargite RED.
Moreover, the beer processing study (MRID 42486301 Ball, J. (1992)
Omite CR on Hops: Beer Processing Study: Lab Project Number: RP-90043:
ML91-0271UNI: IR90-747. Unpublished study prepared by Uniroyal
Chemical Company, Inc. 369 p.) used hops bearing measurable residues up
to 22.5 ppm propargite on dried hop cones from
[[Page 41921]]
1.5X treated green hops and demonstrated that propargite residues were
not detected in beer (< 0.01 ppm). However, at the time of the
propargite RED, Codex had a value of 30 mg/kg on dried hops. EPA agrees
with the commenter that the 100 mg/kg MRL on dried hops for propargite,
established by Codex, is appropriate based on the data reviewed by the
2002 JMPR. However, because EPA did not propose any action on hops,
dried cones in 40 CFR 180.259 for propargite on August 4, 2004 (69 FR
47051), the Agency will not take action on that tolerance in this
document. Therefore, EPA intends to propose increasing the tolerance on
hop, dried cones to harmonize with the Codex MRL in a future
publication in the Federal Register.
Also, the tolerance definition of the raw agricultural commodity
(RAC) for hops is dried cones (PR Notice 93-12; December 23, 1993).
Therefore, because the RAC for hops is dried hops, whose use is covered
by the existing tolerance at 30.0 ppm, EPA is revoking the tolerance in
40 CFR 180.259(a) on hop at 15.0 ppm.
Also, in response to the comment, there is no tolerance in 40 CFR
180.259 for propargite on garlic. According to 40 CFR 180.1(g), on
tolerance definitions, a tolerance on onions or onions (dry bulb only)
would cover garlic; however, there is also no tolerance in 40 CFR
180.259 for propargite on onion. In the proposed rule of August 4, 2004
(69 FR 47051), the Agency did not propose any action on the existing
tolerances in 40 CFR 180.259 for propargite residues on almond and
walnut, whose U.S. tolerance levels of 0.1 ppm harmonize with the Codex
MRLs of 0.1 mg/kg. The representative commodities for the tree nut
group are almond and pecan. There is no pecan tolerance and no tree nut
group tolerance for propargite. Both the almond and almond hulls
tolerances were recommended in the propargite RED to be maintained at
their current tolerance levels based on available data where treated
almonds were harvested at 28 days, because a 28-day preharvest interval
(PHI) is specified on active product labels.
Based on available data, EPA determined that there is no reasonable
expectation of finite residues of propargite in poultry meat and meat
byproducts. These tolerances are no longer needed under 40 CFR
180.6(a)(3). Therefore, EPA is revoking the commodity tolerances in 40
CFR 180.259(a) for residues of propargite in or on ``poultry, meat''
and ``poultry, meat byproducts.'' Also, EPA is revoking the tolerance
in 40 CFR 180.259(a) for residues of propargite in or on ``citrus,
dried pulp'' because residues do not concentrate in dried pulp based on
a citrus processing study, and therefore the tolerance is no longer
needed. In addition, EPA is revoking the tolerance in 40 CFR 180.259
for residues of propargite in or on ``peanut, hulls'' because it is no
longer considered to be a significant livestock feed commodity and
therefore the tolerance is no longer needed. The tolerance for peanut
forage, which had been proposed for revocation, was removed on December
13, 2006 (71 FR 74802) (FRL-8064-3), when EPA finalized certain
tolerance nomenclature changes, including the revision of the tolerance
in 40 CFR 180.259 on peanut, forage to peanut, hay, which then became a
duplicate tolerance (covered by an existing tolerance for peanut hay).
Based on field trial data that indicate propargite residues as high
as 8.3 ppm in or on oranges and 3.8 ppm in or on sorghum grain, the
Agency determined that the tolerances should be increased to 10.0 ppm
for oranges and decreased to 5.0 ppm for sorghum grain. Therefore, EPA
is increasing the tolerance in 40 CFR 180.259(a) on ``orange, sweet''
from 5 ppm to 10.0 ppm and revising the terminology to ``orange,'' and
decreasing the tolerance on ``sorghum, grain'' from 10 ppm to 5.0 ppm.
The Agency determined that the increased tolerance is safe; i.e., there
is a reasonable certainty that no harm will result from aggregate
exposure to the pesticide chemical residue.
Based on HAFT residues of 4 ppm (residue range 1.6 ppm to 8.3 ppm)
in oranges and available processing data showing an average
concentration factor of 7.0x in orange oil, the Agency determined that
a tolerance should be established for propargite on citrus oil at 30
ppm. Therefore, EPA is establishing a tolerance in 40 CFR 180.259(a)
for residues of propargite in ``citrus, oil'' at 30.0 ppm.
Available processing data indicate that propargite residues do not
concentrate in aspirated grain fractions of sorghum, but do concentrate
in aspirated grain fractions of field corn as high as 0.35 ppm. The
Agency determined that a tolerance should be established for aspirated
grain fractions at 0.4 ppm. Therefore, EPA is establishing a tolerance
in 40 CFR 180.259(a) for residues of propargite in or on ``grain,
aspirated fractions'' at 0.4 ppm.
In order to conform to current Agency practice, in 40 CFR
180.259(a), EPA is revising ``corn, forage'' to ``corn, field, forage''
and ``corn, sweet, forage;'' ``corn, grain'' to ``corn, field, grain''
and ``corn, pop, grain;'' ``mint'' to ``peppermint, tops'' and
``spearmint, tops;'' and ``sorghum, forage'' to ``sorghum, grain,
forage.''
In the proposed rule of August 4, 2004 (69 FR 47051), EPA stated
that peanut hay is no longer considered to be a significant livestock
feed commodity. In fact, peanut hay is considered by the Agency to be a
significant livestock feed item as shown at http://www.epa.gov/opptsfrs/OPPTS_Harmonized/860_Residue_Chemistry_Test_Guidelines/Series/
in the Residue Chemistry Test Guidelines OPPTS 860.1000 Table
1. However, registration labels prohibit the feeding of propargite-
treated peanut hay to livestock as stated in the propargite RED.
Nevertheless, because in the proposed rule of August 4, 2004 (69 FR
47051) the Agency did not identify the feeding restriction as a basis
for proposing revocation of the peanut hay tolerance, the Agency will
take no action on it in this document. EPA intends to address proposing
the revocation of the tolerance for residues of propargite in or on
peanut, hay in a future document to be published in the Federal
Register.
No comments were received by the Agency concerning the following.
7. Diclofop-methyl. As noted in the September 2000 RED, uses of
diclofop-methyl on lentils and dry peas have been deleted from
registered labels. The use on lentils may have been canceled since
1985. Therefore, EPA is revoking the tolerances in 40 CFR 180.385 for
lentil, seed and pea seeds (dry).
Also, in support of tolerance reassessment, the registrant
developed a new enforcement method HRAV-14 gas liquid chromatogragphy/
electron capture detector (HRAV-14 GLC/ECD) and subjected a ruminant
metabolism study to independent laboratory validation. However, EPA has
not yet determined that the newly submitted method is valid. The
current FDA enforcement method for diclofop-methyl is the Pesticide
Analytical Manual (PAM)-Volume II, which does not detect a metabolite
of concern, diclofop acid. Therefore, at this time, EPA will not
establish any new tolerances that are recommended in the diclofop-
methyl RED. The Agency will address establishing such tolerances in a
future document in the Federal Register.
8. Diquat dibromide. The Diquat dibromide RED was completed in July
1995 and the existing tolerances were reassessed according to the FQPA
standard in the April 2002 TRED. EPA has determined that the tolerance
expression in 40 CFR 180.226(a)(1) should be amended by defining diquat
as both a plant growth regulator and
[[Page 41922]]
herbicide. Therefore, EPA is amending the tolerance expression in 40
CFR 180.226(a)(1) to read `` ... residues of the plant growth regulator
and herbicide diquat ... ''.
On July 1, 2003, (68 FR 39427) (FRL-7308-9) EPA revised potato,
waste, dried in 40 CFR 180.226(a)(1) to read potato, processed potato
waste, but should have revised it to read potato, processed potato
waste, dried. Processed, dried potato waste is no longer a significant
animal feed item. Therefore, EPA is revoking the tolerances for potato,
processed potato waste in Sec. 180.226(a)(1) and processed, dried
potato waste in Sec. 180.226(a)(6) because the associated commodities
are no longer significant animal feed items and these tolerances are
therefore no longer needed.
In order to achieve compatibility with CODEX (see Unit III.,
below), EPA is increasing the tolerances in 40 CFR 180.226(a)(1) for
egg and fat, meat, and meat byproducts of cattle, goats, hogs, horses,
poultry, and sheep, from 0.02 ppm to 0.05 ppm.
Available data indicate that residues of diquat in fish and
shellfish will exceed the established tolerances at current maximum
registered use patterns. In order to cover all residues of diquat which
may occur as a result of the currently registered uses, increasing the
tolerances to 2.0 ppm for fish and 20.0 ppm for shellfish is
appropriate. Therefore, EPA is increasing the tolerances in 40 CFR
180.226(a)(2)(i) for residues of diquat on ``fish'' from 0.1 ppm to 2.0
ppm and ``shellfish'' from 0.1 ppm to 20.0 ppm. The Agency determined
that the increased tolerances are safe; i.e., there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue.
The available data concerning diquat residues following irrigation
indicate that residues in or on blackberry, cowpea, orange, strawberry,
mustard greens, pasture grass, and tomato may exceed the current
tolerances for the respective crop groups and that tolerances should be
increased to 0.05 ppm for citrus fruits, small fruits, fruiting
vegetables, legume vegetables, and Brassica leafy vegetables, and to
0.20 ppm for grass forage. Therefore, EPA is increasing the tolerances
in 40 CFR 180.226(a)(2)(i) for residues of diquat on ``fruit, citrus,
group 10'' from 0.02 ppm to 0.05 ppm; ``vegetable, fruiting, group 8''
from 0.02 ppm to 0.05 ppm; ``vegetable, leafy'' from 0.02 ppm to 0.05
ppm and revising the terminology to read ``vegetable, leafy, except
brassica, group 4'' and ``vegetable, brassica, leafy, group 5;'' and by
increasing the tolerance level for ``vegetable, seed and pod'' from
0.02 ppm to 0.05 ppm; and ``grass, forage'' from 0.1 ppm to 0.2 ppm and
revising the terminology to read ``grass, forage, fodder and hay, group
17.'' Also, EPA is increasing the tolerance in 40 CFR 226(a)(2)(i) for
residues of diquat on ``fruit, small'' from 0.02 ppm to 0.05 ppm.
Instead of revising the terminology to read ``fruit, small and berry
group,'' as was proposed, EPA is revising the terminology consistent
with the Agency response made in this document to a comment on
paraquat; i.e., the old terminology of small fruit for diquat will be
separated into individual tolerances for cranberry, grape, and
strawberry, as well as berry group 13, each at 0.05 ppm. The Agency
determined that the increased tolerances are safe; i.e., there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue.
While no data are available for the miscellaneous commodities
avocado, cottonseed, hops, and sugarcane for which tolerances currently
exist, the Agency determined that data for other crops could be
translated. Based on the highest residues found in other irrigated
crops resulting from irrigation with water containing diquat residues,
the Agency determined that tolerances of 0.20 ppm are appropriate for
avocado, cottonseed, hops, and sugarcane. Therefore, EPA is increasing
the tolerances in 40 CFR 180.226(a)(2)(i) for residues of diquat in or
on ``avocado,'' ``cotton, undelinted seed,'' and ``sugarcane, cane;''
each from 0.02 ppm to 0.2 ppm, and ``hop, dried cones'' from 0.02 ppm
to 0.2 ppm. The Agency determined that the increased tolerances are
safe; i.e., there is a reasonable certainty that no harm will result
from aggregate exposure to the pesticide chemical residue.
Because available data show that residues of diquat were as high as
1.6 ppm on sorghum grain and 0.16 ppm on soybean, the Agency determined
that tolerances should be established for sorghum grain at 2.0 ppm, and
both soybean and foliage of legume vegetables at 0.2 ppm. Therefore,
EPA is establishing tolerances in 40 CFR 180.226(a)(1) for residues of
diquat in or on ``sorghum, grain, grain'' at 2.0 ppm, ``soybean, seed''
at 0.2 ppm, and increasing the tolerance in 40 CFR 180.226(a)(2)(i) on
``vegetable, foliage of legume, group 7'' from 0.1 ppm to 0.2 ppm. The
Agency determined that the increased tolerance is safe; i.e., there is
a reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue.
In addition, soybean processing data indicate that residues of
diquat concentrated about 3x in soybean hulls processed from soybean
bearing detectable residues. No concentration of residues was observed
in other soybean processed fractions. Based on a recommended tolerance
of 0.2 ppm for soybean and a concentration factor of about 3x in
soybean hulls, the Agency determined that a tolerance of 0.6 ppm is
appropriate for residues of diquat on soybean hulls. Therefore, EPA is
establishing a tolerance for residues of diquat in Sec. 180.226(a)(3)
for ``soybean, hulls'' at 0.6 ppm.
Based on field trial data on alfalfa grown for seed that show
residues of diquat were as high as 2.4 ppm, the Agency determined that
a tolerance of 3.0 ppm is appropriate and should be established.
Therefore, EPA is establishing a tolerance in Sec. 180.226(a)(1) for
``alfalfa, seed'' at 3.0 ppm. Also, in the diquat TRED, EPA recommended
the establishment of a tolerance on clover seed at 2.0 ppm. However, a
tolerance for ``clover, seed'' is not needed because clover seed is no
longer considered by the Agency to be a significant food or feed item.
EPA is revising commodity terminology to conform to current Agency
practice as follows: in 40 CFR 180.226(a)(2)(i), ``grain, crop'' to
read ``grain, cereal, group 15'' and ``grain, cereal, forage, fodder
and straw, group 16.''
While the Agency did propose to revise tolerance terminology from
coffee to coffee, bean in 40 CFR 180.226(a)(3), the Agency did not
propose in a notice for comment to revise that tolerance on coffee to
coffee, bean, green, as is current Agency practice. However, section
553(b)(3)(B) of the Administrative Procedure Act provides that notice
and comment is not necessary ``when the agency for good cause finds
(and incorporates the finding and a brief statement of reasons
therefore in the rules issued) that notice and public procedure thereon
are impracticable, unnecessary, or contrary to the public interest.''
Consequently, for good cause, EPA is revising the tolerance in 40 CFR
180.226(a)(3) from coffee to coffee, bean, green. The reason for taking
this action is because such action has no practical impact on the use
of or exposure to the pesticide active ingredient, diquat, in or on
that commodity and is made such that the tolerance terminology will
conform to current Agency practice.
9. 5-Ethoxy-3-(trichloromethyl)-1,2,4-thiadiazole (etridiazole or
terrazole). Based on available data, EPA determined that there is no
reasonable
[[Page 41923]]
expectation of finite residues of etridiazole and its metabolites on or
in animal livestock commodities. These tolerances are no longer needed
under 40 CFR 180.6(a)(3). Therefore, EPA is revoking the commodity
tolerances in 40 CFR 180.370(a) for residues of etridiazole and its
monoacid metabolite in or on ``cattle, fat;'' ``cattle, meat
byproducts;'' ``cattle, meat;'' ``egg;'' ``goat, fat;'' ``goat, meat
byproducts;'' ``goat, meat;'' ``hog, fat;'' ``hog, meat byproducts;''
``hog, meat;'' ``horse, fat;'' ``horse, meat byproducts;'' ``horse,
meat;'' ``milk;'' ``poultry, fat;'' ``poultry, meat byproducts;''
``poultry, meat;'' ``sheep, fat;'' ``sheep, meat byproducts;'' and
``sheep, meat.''
Since 1989, there have been no active registrations for etridiazole
use on strawberries and therefore the tolerance is no longer needed.
Consequently, EPA is revoking the tolerance for strawberry in 40 CFR
180.370.
The Agency determined that metabolism data at exaggerated rates of
etridiazole seed treatments on cotton, soybean, and wheat would support
seed treatment uses on barley, beans, corn, cotton, peanuts, peas,
safflower, sorghum, soybeans, and wheat. Residues of etridiazole per se
were non-detectable on soybeans and wheat, but as high as 0.06 ppm on
cotton. Residues of the monoacid metabolite are expected not to exceed
0.04 ppm based on the metabolism data from seed treated at 1-fold
amounts. Based on these data, the Agency determined that appropriate
tolerances for combined residues of etridiazole and its monoacid
metabolite for treated seed should be set at the combined limit of
quantitation (0.1 ppm) of the available enforcement method. Therefore,
EPA is increasing the tolerances in 40 CFR 180.370 for ``wheat, grain''
from 0.05 ppm to 0.1 ppm, and ``corn, field, grain'' from 0.05 ppm to
0.1 ppm. Also, EPA is decreasing the tolerance in 40 CFR 180.370 for
``cotton, undelinted seed'' from 0.20 ppmto 0.1 ppm based on available
data. In addition, based on available data, EPA is establishing
tolerances in 40 CFR 180.370 at 0.1 ppm for ``barley, grain;''
``barley, hay;'' ``cotton, gin byproducts;'' ``peanut;'' ``safflower,
seed;'' ``sorghum, grain, forage;'' ``sorghum, grain, grain;''
``vegetable, foliage of legume, group 7;'' and ``vegetable, legume,
group 6.'' The Agency determined that the increased tolerances are
safe; i.e., there is a reasonable certainty that no harm will result
from aggregate exposure to the pesticide chemical residue.
In order to conform to current Agency practice, in 40 CFR 180.370,
EPA is proposing to revise ``corn, forage'' to read ``corn, field,
forage'' and ``corn, sweet, forage,'' and ``corn, stover'' to read
``corn, field, stover'' and ``corn, sweet, stover.''
In the proposed rule of August 4, 2004 (69 FR 47051), EPA stated
that peanut hay is no longer considered to be a significant livestock
feed commodity. In fact, peanut hay is considered by the Agency to be a
significant livestock feed item as shown at http://www.epa.gov/opptsfrs/OPPTS_Harmonized/860_Residue_Chemistry_Test_Guidelines/Series/
in the Residue Chemistry Test Guidelines OPPTS 860.1000 Table
1. Therefore, the Agency intends to address proposing the establishment
of a tolerance for residues of etridiazole and its monoacid metabolite
in or on peanut hay in a future document to be published in the Federal
Register.
Also in the proposed rule of August 4, 2004 (69 FR 47051), the
Agency noted the registrant's support of the tomato tolerance in 40 CFR
180.370 for import purposes and the lack of a FIFRA registration
because at the time of the RED, the registrant had committed to provide
additional data in order to maintain the tomato tolerance for import
purposes. However, since the RED, EPA approved several section 24(c)
FIFRA registrations for regional domestic use of etridiazole on
tomatoes. Consequently, EPA will not amend the tolerance in 40 CFR
180.370 on tomato with a statement regarding the lack of a FIFRA
registration.
10. Fenbutatin-oxide. The Fenbutatin-oxide RED was completed in
September 1994 and the existing tolerances were reassessed according to
the FQPA standard in the May 2002 TRED. EPA determined that in order to
better harmonize with Codex, the fenbutatin-oxide (hexakis (2-methyl-2-
phenylpropyl) distannoxane) tolerance expression for plants should
include the parent compound only. Therefore, in 40 CFR 180.362(a), EPA
is recodifying plant tolerances in Sec. 180.362(a)(1) and animal
tolerances in Sec. 180.362(a)(2). Moreover, EPA is revising the
tolerance expression such that tolerances in Sec. 180.362(a)(1) are
established for residues of hexakis (2-methyl-2-phenylpropyl)
distannoxane and tolerances in Sec. 180.362(a)(2) are established for
the combined residues of hexakis (2-methyl-2-phenylpropyl) distannoxane
and its organotin metabolites dihydroxybis(2-methyl-2-
phenylpropyl)stannane, and 2-methyl-2-phenylpropylstannoic acid.
Also, EPA is removing the tolerance in 40 CFR 180.362 for ``plum,
prune'' because that tolerance is no longer needed since that use is
covered by the dried plum tolerance. In addition, EPA is revising the
commodity tolerance terminology ``plum'' to read ``plum, prune,
fresh.''
Because available data for almond, pecan, and walnut support a crop
group tolerance; EPA is reassigning their individual tolerances in 40
CFR 180.362 into a group tolerance ``nut, tree, group 14'' and
maintaining the tolerance at 0.5 ppm.
The Agency determined that a tolerance on apple wet pomace should
be established at 100 ppm because available apple processing data
indicate that combined fenbutatin-oxide residues of concern concentrate
1.7x in wet pomace. Based on that processing data, EPA is establishing
a tolerance in 40 CFR 180.362(a)(1) for ``apple, wet pomace'' at 100.0
ppm.
In addition, EPA is revising commodity terminology in 40 CFR
180.362 to conform to current Agency practice as follows: ``fruit,
citrus'' to read ``fruit, citrus, group 10.''
11. Folpet. EPA is recodifying the tolerance for ``avocado'' at 25
ppm from 40 CFR 180.191(a) into 40 CFR 180.191(c) as a tolerance with
regional registration because the use of folpet on avocados is limited
to the state of Florida, and there is no need for a national tolerance.
Additional residue data would be required to establish a tolerance for
folpet use on avocados outside the state of Florida.
With the exception of ``avocado'' and ``hop, dried cones,'' the
registrant is supporting the remaining folpet tolerances for import
purposes only and EPA is designating them as import tolerances with no
U.S. registrations. These import tolerances are based on the best
available field trial and storage stability data and assume use at a
maximum single and seasonal application rate, minimum PHI, and minimum
retreatment interval for each crop. For some commodities, the import
tolerances should be lower than the old tolerance with a U.S.
registration because the import tolerances are based on different use
information than that on which the previous tolerances were based.
Therefore, EPA is modifying certain tolerances for folpet to reflect
the best available foreign field trial data. Therefore, use of folpet
outside the United States should not exceed the maximum use rate,
minimum preharvest interval, and retreatment interval specified herein.
Any use pattern exceeding these maximum single and seasonal application
rates, minimum PHIs, and minimum retreatment intervals may result in
residues exceeding U.S. tolerance levels.
[[Page 41924]]
Available field trial data indicate that folpet residues ranged up
to 3.67 ppm in or on apples harvested 7 to 10 days following the last
of several applications (14 day retreatment interval) at 0.8 ppm to
3.59 kg ai/ha. Based on the available residue field trial data, the
Agency determined that a tolerance of 5 ppm on apple is appropriate
provided that use directions do not exceed a maximum single application
rate of 3.6 kg ai/ha, a maximum seasonal application rate of 10.8 kg
ai/ha, a minimum PHI of 10 days, and a treatment interval of 14 days.
Therefore, EPA is decreasing the tolerance in 40 CFR 180.191(a) on
``apple'' from 25.0 ppm to 5.0 ppm.
Foreign field trial data on cranberries indicate that folpet
residues ranged up to 11.2 ppm in or on cranberries harvested 30 days
following the last of three broadcast applications (separated by a 12-
to 14-day retreatment interval) at 5.0 Kilogram active ingredient/
hectare/application (kg a.i./ha/application). Although the submitted
data do not reflect the maximum label use pattern of folpet on
cranberries (which is limited to only two applications and not three
applications as tested here), the Agency accepted the current field
trial data and determined that a tolerance of 15 ppm is appropriate on
cranberries. Therefore, EPA is decreasing the tolerance in 40 CFR
180.191(a) for ``cranberry'' from 25.0 ppm to 15.0 ppm.
Foreign field trial data on onions indicate that folpet residues
ranged up to 0.406 ppm in or on dry bulb onions harvested 7 days
following the last of either three or four applications (with a 7-day
retreatment interval) of folpet at either 1.5- or 1.95 kg ai/ha per
application. Based on the available residue field trial data, the
Agency determined that a tolerance of 2.0 ppm is appropriate on dry
bulb onions provided that the use directions do not exceed a maximum
application rate of 1.95 kg ai/ha, a minimum PHI of 7 days, and a 7-day
retreatment interval. Therefore, EPA is decreasing the tolerance in 40
CFR 180.191(a) for ``onion, dry bulb'' from 15.0 ppm to 2.0 ppm.
Foreign field trial data on strawberries indicate that folpet
residues ranged up to 2.56 ppm in or on strawberries harvested 2 days
following the last of four applications at 1.25 kg ai/ha per
application. Based on the available residue field trial data, the
Agency determined that a tolerance of 5 ppm on strawberries is
appropriate provided the use directions do not exceed a maximum of four
applications per season at up to 1.25 kg ai/application, and specify a
retreatment interval of 7 days and a preharvest interval of 2 days.
Therefore, EPA is decreasing the tolerance in 40 CFR 180.191(a) for
``strawberry'' from 25.0 ppm to 5.0 ppm.
Foreign field trial data on grapes indicate that folpet residues
ranged up to 38.3 ppm in or on grapes harvested 14 days following the
last of five applications (with a 5- to 7-day retreatment interval) at
1.49 kg ai/ha per application. Based on the available residue field
trial data, the Agency determined that a tolerance of 50 ppm on grape
is appropriate provided that use rates do not exceed a maximum single
application rate of 1.5 kg ai/ha, a maximum seasonal rate of 8.0 kg ai/
ha, a minimum PHI of 7 days, and a 7-day retreatment interval.
Therefore, EPA is increasing the tolerance in 40 CFR 180.191(a) for
``grape'' from 25 ppm to 50.0 ppm. The Agency has determined that the
increased tolerance is safe; i.e., there is a reasonable certainty that
no harm will result from aggregate exposure to folpet residues.
No U.S. registration exists for use of folpet on raisins. However,
grape processing data show that the average concentration factor from
grapes to raisins for folpet residues is 1.9x. Based on an average
concentration factor of 1.9x and a HAFT of 38.3 ppm, the Agency
determined that for import purposes a tolerance of 80.0 ppm should be
established for grape, raisin. Therefore, EPA is establishing a
tolerance in 40 CFR 180.191(a) for ``grape, raisin'' at 80.0 ppm.
Tolerances for ``lettuce'' and ``tomato'' will be maintained at the
current level of 50.0 ppm and 25.0 ppm, respectively, for import
purposes only. There are no U.S. registrations for use of folpet on
these commodities.
Foreign field trials for cucumbers harvested 3 to 7 days following
the last of several applications indicate residues of folpet up to
0.699 ppm at an application rate up to 1.75 kg/ai/ha. Therefore, EPA
has determined that a tolerance of 2.0 ppm is appropriate for imported
cucumbers, provided that use of folpet outside the United States does
not exceed a maximum single application rate of 1.75 kg ai/ha, a
maximum seasonal application rate of 8.0 kg ai/ha, a minimum preharvest
interval of at least 3 days, and a minimum retreatment interval of at
least 7 days. Also, foreign field trials for melons harvested 7 days
following the last of up to 6 applications at a maximum application
rate of 1.75 kg ai/ha (with a 5- to 7-day retreatment interval)
indicate residues of folpet up to 2.3 ppm. Therefore, EPA has
determined that a tolerance of 3.0 ppm is appropriate for imported
melons, provided that use of folpet outside the United States does not
exceed a maximum single application rate of 1.75 kg ai/ha, a maximum
seasonal application rate of 10.5 kg ai/ha, a minimum preharvest
interval of at least 7 days, and a minimum retreatment interval of at
least 7 days. Based on the available residue field trial data, the
Agency has determined that the tolerances on cucumber and melon should
be decreased from 15.0 ppm to 2.0 ppm and from 15.0 ppm to 3.0 ppm,
respectively. Therefore, EPA is decreasing the tolerances in 40 CFR
180.191(a) on cucumber to 2.0 ppm and melon to 3.0 ppm.
The Agency did not propose in a notice for comment to revise the
tolerance nomenclature for folpet in 40 CFR 180.191(a) from onion, dry
bulb to onion, bulb, as is current Agency practice. However, section
553(b)(3)(B) of the Administrative Procedure Act provides that notice
and comment is not necessary ``when the agency for good cause finds
(and incorporates the finding and a brief statement of reasons
therefore in the rules issued) that notice and public procedure thereon
are impracticable, unnecessary, or contrary to the public interest.''
Consequently, for good cause, EPA is revising the tolerance terminology
in 40 CFR 180.191(a) from onion, dry bulb to read onion, bulb. The
reason for taking this action is because such action has no practical
impact on the use of or exposure to the pesticide active ingredient,
folpet, in or on that commodity and is made such that the tolerance
terminology will conform to current Agency practice.
Since the folpet RED was completed in 1999, a tolerance for the
purpose of importation was established in 40 CFR 180.191(a) for ``hop,
dried cones'' (68 FR 10377, March 5, 2003)(FRL-7296-2) and later, based
on the Agency's approval of a petition for a FIFRA registration
regarding folpet use on U.S. grown hop, dried cones, the tolerance for
hop, dried cones was amended to delete the statement regarding the lack
of a FIFRA registration on August 25, 2004 (69 FR 52182) (FRL-7369-1.
12. Hydramethylnon (Pyrimidinone). EPA is increasing the following
commodity tolerances in 40 CFR 180.395(a): ``grass (pasture and
rangeland)'' from 0.05 ppm to 2.0 ppm and revising the terminology to
``grass, forage'' and ``grass, hay;'' based on available field trial
data which show residues of hydramethylnon above the current tolerance
level and label amendments which reflect parameters of use patterns for
which field trials are available; (i.e., reflect a 0 day post
[[Page 41925]]
harvest interval) since the Agency no longer allows a PHI restriction
on grass. The tolerance for ``grass hay (pasture and rangeland)'' was
recommended to be increased from 0.05 ppm to 0.1 ppm, based on
available field trial data previously discussed and label amendments
which reflect a 0 day post harvest interval. However, because the
terminology should be revised to ``grass, hay,'' that tolerance at 0.1
ppm is no longer needed since it would be a duplicate covered by the
proposed tolerance at 2.0 ppm. Therefore, EPA is removing the tolerance
in 40 CFR 180.395(a) for grass hay (pasture and rangeland).
After the hydramethylnon RED was completed in 1998, a permanent
tolerance was established in 40 CFR 180.395(a) on pineapple (68 FR
48302, August 13, 2003)(FRL-7319-5). Since the proposal of August 4,
2004 (69 FR 47051), the time-limited tolerance for hydramethylnon
residues on pineapple in 40 CFR 180.395(b), for section 18 emergency
exemptions, expired on June 30, 2005. The Agency did not propose in a
notice for comment to remove the text and table with the expired
tolerance and reserve 40 CFR 180.395(b). However, section 553(b)(3)(B)
of the Administrative Procedure Act provides that notice and comment is
not necessary ``when the agency for good cause finds (and incorporates
the finding and a brief statement of reasons therefore in the rules
issued) that notice and public procedure thereon are impracticable,
unnecessary, or contrary to the public interest.'' Consequently, for
good cause, EPA is removing the text and table from 40 CFR 180.395(b)
and reserving that section for emergency exemptions in this document.
The reason for taking this action is because such action has no
practical impact on the use of or exposure to the pesticide active
ingredient, hydramethylnon, since the sole time-limited tolerance in 40
CFR 180.395(b) had expired and, as it no longer needs to be codified in
that section, should be removed for the sake of clarity.
13. Phosphine. EPA is removing the commodity tolerance in 40 CFR
180.225(a)(1) for residues of phospine in or on ``pimento;'' because
under 40 CFR 180.1(g) this tolerance is covered by the existing
tolerance for pepper.
14. Picloram. The Picloram RED was completed in March 1995 and the
existing tolerances were reassessed according to the FQPA standard when
new tolerances were established on January 5, 1999 (64 FR 418)(FRL-
6039-4). Because the tolerances at 3.0 ppm in 40 CFR 180.292(a)(3) for
residues of picloram in or on barley, milled fractions (exc flour);
oat, groats/rolled oats (previously known as oat, milled fractions (exc
flour)); and wheat, milled fractions (exc flour) are duplicates covered
by the tolerances at 3.0 ppm in 40 CFR 180.292(a)(2), there is no
longer a need for them and therefore, EPA is removing the tolerances in
40 CFR 180.292(a)(3) for residues of picloram in or on barley, milled
fractions (exc flour); oat, groats/rolled oats, and wheat, milled
fractions (exc flour).
Because the time-limited tolerances on aspirated grain fractions,
sorghum grain, forage, and stover for indirect or inadvertent residues
in 40 CFR 180.292(d) all expired on December 31, 2000, there is no
longer a need to codify them in that part. Therefore, EPA is amending
40 CFR 180.292(d) by removing the existing paragraph and table of
expired tolerances, and reserving the paragraph designation.
Based on the concentration of picloram residues in the aspirated
grain fractions of wheat, EPA is establishing tolerances in 40 CFR
180.292(a)(1) for ``grain, aspirated fractions'' at 4.0 ppm.
In order to conform to current Agency practice, in 40 CFR
180.292(a)(2), EPA is revising ``barley, milled fractions (exc flour)''
to read ``barley, pearled barley;'' and ``wheat, milled fractions (exc
flour)'' to read ``wheat, bran;'' ``wheat, germ;'' ``wheat,
middlings;'' and ``wheat, shorts.''
EPA will not take action on the tolerance in 40 CFR 180.292(a)(1)
for ``grass, forage'' or establish a tolerance for ``grass, hay'' at
this time due to label and data issues. However, the Agency intends to
clarify these issues with the registrants.
15. Triclopyr. EPA has determined that the residue which should be
regulated in grass and rice commodities and milk, poultry, and eggs is
triclopyr per se. The Agency has also determined that the residue which
should be regulated in meat and meat byproducts are the combined
residues of triclopyr and the metabolite 3,5,6-trichloro-2-pyridinol
(TCP). Therefore, EPA is revising the tolerance expression in 40 CFR
180.417(a)(1) to reflect residues of triclopyr per se as a result of
the application/use of butoxyethyl ester of triclopyr and triethylamine
salt of triclopyr. In addition, EPA is recodifying tolerances for
``egg,'' ``milk,'' ``poultry, fat;'' ``poultry, meat byproducts, except
kidney;'' ``poultry, meat;'' ``rice, grain;'' and ``rice, straw;'' from
40 CFR 180.417(a)(2) to (a)(1).
Also, EPA is amending the tolerance expression in 40 CFR
180.417(a)(2) to reflect the combined residues of the herbicide
triclopyr ((3,5,6-trichloro-2-pyridinyl)oxy) acetic acid and its
metabolite 3,5,6-trichloro-2-pyridinol (TCP) as a result of the
application/use of butoxyethyl ester of triclopyr or the triethylamine
salt of triclopyr.
Since the time of the Triclopyr RED, the Agency has determined that
a proposal by the registrant to increase the tolerance for ``grass,
forage'' from 500 ppm to 700 ppm is acceptable provided that
registrations specify a maximum application rate of 2 lb. acid
equivalents (ae)/A per annual growing season. The dietary risk
assessment performed as part of the triclopyr RED supports this
increase. The current tolerances on meat commodities are adequate to
cover residues that may occur from grazing areas treated at 2 lb. ae/A.
Therefore, EPA is increasing the tolerance in 40 CFR 180.417(a)(1) on
``grass, forage'' to 700.0 ppm. Also, the Agency is revising in 40 CFR
180.417(a)(1) the commodity terminology ``grass, forage, hay'' to read
``grass, hay'' and decreasing the tolerance from 500.0 ppm to 200.0
ppm, based on available data and label amendments. The Agency
determined that the increased tolerance is safe; i.e., there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue.
Since the triclopyr RED was completed in 1997, tolerances were
established in 40 CFR 180.417(a)(1) for ``fish'' and ``shellfish'' (67
FR 58712, September 18, 2002)(FRL-7196-7).
16. Triphenyltin hydroxide (TPTH). Since TPTH residues of concern
in plant and animal commodities have been determined to include TPTH
and its monophenyltin (MPTH) and diphenyltin (DPTH) hydroxide and oxide
metabolites, EPA is revising the tolerance definition in 40 CFR 180.236
in terms of the combined residues of TPTH and its MPTH and DPTH
hydroxide and oxide metabolites, expressed in terms of parent TPTH.
Based on available ruminant feeding data that indicate combined
TPTH-regulated residues as high as 1.15 ppm in kidney and 3.7 ppm in
liver, the Agency determined that the appropriate tolerances for kidney
and liver of cattle, goats, horses, and sheep are 2.0 ppm and 4.0 ppm,
respectively. Therefore, EPA is increasing the tolerances in 40 CFR
180.236 for ``cattle, liver;'' ``goat, liver;'' ``horse, liver;'' and
``sheep, liver;'' each from 0.05 ppm to 4.0 ppm, ``cattle, kidney;''
``goat, kidney;'' ``horse, kidney;'' and ``sheep, kidney;'' each from
0.05 ppm to 2.0 ppm. The Agency determined that the increased
tolerances are safe; i.e., there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue.
[[Page 41926]]
Also, because available ruminant feeding data show combined TPTH-
regulated residues as high as 0.14 ppm in fat and 0.34 ppm in meat, the
Agency determined that the appropriate tolerances should be established
for fat and meat of cattle, goats, horses, and sheep at 0.2 ppm and 0.5
ppm, respectively. Moreover, based on non-detectable levels and
combined LOQs of 0.02 ppm for each metabolite, the Agency determined
that a tolerance should be established for milk at 0.06 ppm. Therefore,
EPA is establishing tolerances in 40 CFR 180.236 for ``cattle, fat;''
``goat, fat;'' ``horse, fat;'' and ``sheep, fat;'' each at 0.2 ppm;
``cattle, meat;'' ``goat, meat;'' ``horse, meat;'' and ``sheep, meat;''
each at 0.5 ppm, and ``milk'' at 0.06 ppm.
The ruminant feeding data was also used by the Agency to reassess
tolerances for swine. EPA determined that tolerances for hog kidney and
liver should be increased to 0.3 ppm (the combined LOQs of 0.1 ppm for
residues in kidney, liver and fat), and that these separate tolerances
should be combined as hog, meat byproducts. In addition, EPA determined
that tolerances should also be established for hog fat at 0.3 ppm (the
combined LOQs of 0.1 ppm for each metabolite), and in hog meat at 0.06
ppm (the combined LOQs of 0.02 ppm for each metabolite). Therefore, EPA
is revising the commodity tolerances in 40 CFR 180.236 for ``hog,
kidney'' and ``hog, liver'' at 0.05 ppm into the commodity tolerance
``hog, meat byproducts'' and increasing the tolerance to 0.3 ppm, and
establishing tolerances for ``hog, fat'' at 0.3 ppm and ``hog, meat''
at 0.06 ppm. The Agency determined that the increased tolerance is
safe; i.e., there is a reasonable certainty that no harm will result
from aggregate exposure to the pesticide chemical residue.
Based on available field trial data that show combined TPTH-
regulated residues as high as 9.7 ppm, the Agency determined that a
tolerance should be established at 10.0 ppm for beet, sugar, tops.
Therefore, EPA is establishing a tolerance in 40 CFR 180.236 for
``beet, sugar, tops'' at 10.0 ppm.
B. What is the Agency's Authority for Taking this Action?
EPA may issue a regulation establishing, modifying, or revoking a
tolerance under FFDCA section 408(e). In this final rule, EPA is
establishing, modifying, and revoking tolerances to implement the
tolerance recommendations made during the reregistration and tolerance
reassessment processes, and as follow-up on canceled uses of
pesticides. As part of these processes, EPA is required to determine
whether each of the amended tolerances meets the safety standards under
FFDCA. The safety finding determination is found in detail in each
Post-FQPA RED and TRED for the active ingredient. REDs and TREDs
recommend the implementation of certain tolerance actions, including
modifications to reflect current use patterns, to meet safety findings,
and change commodity names and groupings in accordance with new EPA
policy. Printed and electronic copies of the REDs and TREDs are
available as provided in Unit II.A.
EPA has issued post-FQPA REDs for bromoxynil, diclofop-methyl,
dicofol, etridiazole (terrazole), folpet, hydramethylnon, iprodione,
paraquat, phosphine (aluminum and magnesium phosphide), propargite,
triclopyr, and triphenyltin hydroxide (TPTH), and TREDs for diquat and
fenbutatin-oxide, whose REDs were both completed prior to FQPA. Also,
EPA issued a RED prior to FQPA for picloram and in 1999 made a safety
finding which reassessed its tolerances according to the FFDCA
standard, maintaining them when new tolerances were established as
noted in Unit II.A. REDs and TREDs contain the Agency's evaluation of
the data base for these pesticides, including statements regarding
additional data on the active ingredients that may be needed to confirm
the potential human health and environmental risk assessments
associated with current product uses, and REDs state conditions under
which these uses and products will be eligible for reregistration. The
REDs and TREDs recommended the establishment, modification, and/or
revocation of specific tolerances. RED and TRED recommendations such as
establishing or modifying tolerances, and in some cases revoking
tolerances, are the result of assessment under the FFDCA standard of
``reasonable certainty of no harm.'' However, tolerance revocations
recommended in REDs and TREDs that are made final in this document do
not need such assessment when the tolerances are no longer necessary.
EPA's general practice is to revoke 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.
When EPA establishes tolerances for pesticide residues in or on raw
agricultural commodities, the Agency gives consideration to possible
pesticide residues in meat, milk, poultry, and/or eggs produced by
animals that are fed agricultural products (for example, grain or hay)
containing pesticides residues (40 CFR 180.6). If there is no
reasonable expectation of finite pesticide residues in or on meat,
milk, poultry, or eggs, then tolerances do not need to be established
for these commodities (40 CFR 180.6(b) and 180.6 (c)).
C. When Do These Actions Become Effective?
These actions become effective 90 days following publication of
this final rule in the Federal Register. EPA has delayed the
effectiveness of these actions to ensure that all affected parties
receive notice of EPA's actions. Consequently, the effective date is
October 30, 2007. For this final rule, the tolerances that were revoked
because registered uses did not exist concerned uses which have been
canceled, in some cases, for many years. The Agency believes that
existing stocks of pesticide products labeled for the uses associated
with the tolerance revocations have been completely exhausted and that
treated commodities have had sufficient time for passage through the
channels of trade.
Any commodities listed in the regulatory text of this document that
are treated with the pesticides subject to this final rule, and that
are in the channels of trade following the tolerance revocations, shall
be subject to FFDCA section 408(1)(5), as established by the FQPA.
Under this section, any 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
[[Page 41927]]
records that verify the dates that the pesticide was applied to such
food.
III. Are There Any International Trade Issues Raised by this Final
Action?
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international Maximum Residue Limits (MRLs) established
by the Codex Alimentarius Commission, as required by Section 408(b)(4)
of the FFDCA. The Codex Alimentarius is a joint U.N. Food and
Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level in a notice published
for public comment. EPA's effort to harmonize with Codex MRLs is
summarized in the tolerance reassessment section of individual REDs and
TREDs, and in the Residue Chemistry document which supports the RED and
TRED, as mentioned in the proposed rule cited in Unit II.A. Specific
tolerance actions in this rule and how they compare to Codex MRLs (if
any) are discussed in Unit II.A.
IV. Statutory and Executive Order Reviews
In this final rule EPA establishes tolerances under FFDCA section
408(e), and also modifies and revokes specific tolerances established
under FFDCA section 408. The Office of Management and Budget (OMB) has
exempted these types of actions (i.e., establishment and modification
of a tolerance and 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 rule has been exempted from review under Executive Order
12866 due to its lack of significance, this rule is not subject to
Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001). This final rule does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or
contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor
does it require any special considerations as required by Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any other Agency action under
Executive Order 13045, entitled Protection of Children from
Environmental Health Risks and Safety Risks (62 FR 19885, April 23,
1997). This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-13, 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 establishment of
tolerances, exemptions from tolerances, raising of tolerance levels,
expansion of exemptions, or revocations 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. These analyses for tolerance
establishments and modifications, and for tolerance revocations were
published on May 4, 1981 (46 FR 24950) and on December 17, 1997 (62 FR
66020), respectively, and were provided to the Chief Counsel for
Advocacy of the Small Business Administration. Taking into account this
analysis, and available information concerning the pesticides listed in
this rule, the Agency hereby certifies that this final rule will not
have a significant economic impact on a substantial number of small
entities. In a memorandum dated May 25, 2001, EPA determined that eight
conditions must all be satisfied in order for an import tolerance or
tolerance exemption revocation to adversely affect a significant number
of small entity importers, and that there is a negligible joint
probability of all eight conditions holding simultaneously with respect
to any particular revocation. (This Agency document is available in the
docket of the proposed rule, as mentioned in Unit II.A. Furthermore,
for the pesticides named in this final rule, the Agency knows of no
extraordinary circumstances that exist as to the present revocations
that would change EPA's previous analysis. In addition, the Agency has
determined that this action will not have a substantial direct effect
on States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government, as specified in Executive Order 13132,
entitled Federalism (64 FR 43255, August 10, 1999). Executive Order
13132 requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.'' This final
rule directly regulates growers, food processors, food handlers and
food retailers, not States. This action does not alter the
relationships or distribution of power and responsibilities established
by Congress in the preemption provisions of section 408(n)(4) of FFDCA.
For these same reasons, the Agency has determined that this rule does
not have any ``tribal implications'' as described in Executive Order
13175, entitled Consultation and Coordination with Indian Tribal
Governments (65 FR 67249, November 6, 2000). Executive Order 13175,
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' ``Policies that have tribal
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on one or more Indian tribes, on
the relationship between the Federal Government and the Indian tribes,
or on the distribution of power and responsibilities between the
Federal Government and Indian tribes.'' This rule will not have
substantial direct effects on tribal governments, on the relationship
between the Federal Government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this rule.
V. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller
[[Page 41928]]
General of the United States. EPA will submit a report containing this
rule and other required information to the U.S. Senate, the U.S. House
of Representatives, and the Comptroller General of the United States
prior to publication of this final rule in the Federal Register. This
final rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: July 23, 2007.
Debra Edwards,
Director, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is 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.
0
2. Section 180.163 is amended by revising the section heading and
paragraph (a) to read as follows:
Sec. 180.163 1,1-Bis(4-chlorophenyl)-2,2,2-trichloroethanol;
tolerances for residues.
(a) General. (1) Tolerances for the combined residues of the
insecticide dicofol, 1,1-bis(4-chlorophenyl)-2,2,2-trichloroethanol and
1-(2-chlorophenyl)-1-(4-chlorophenyl)-2,2,2-trichloroethanol in or on
raw agricultural commodities are established as follows:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Apple, wet pomace 38.0
Bean, dry, seed............................................ 0.5
Bean, succulent............................................ 3.0
Butternut.................................................. 0.1
Caneberry subgroup 13A..................................... 5.0
Chestnut................................................... 0.1
Citrus, dried pulp......................................... 12.0
Citrus oil................................................. 200.0
Cotton, refined oil........................................ 0.5
Cotton, undelinted seed.................................... 0.1
Fruit, citrus, group 10.................................... 6.0
Fruit, pome, group 11...................................... 10.0
Fruit, stone, group 12..................................... 5.0
Grape...................................................... 5.0
Grape, raisin.............................................. 20.0
Hazelnut................................................... 0.1
Hop, dried cones........................................... 65.0
Nut, hickory............................................... 0.1
Nut, macadamia............................................. 0.1
Pecan...................................................... 0.1
Peppermint, hay............................................ 25.0
Peppermint, oil............................................ 30.0
Spearmint, oil............................................. 30.0
Spearmint, tops............................................ 25.0
Strawberry................................................. 10.0
Tea, dried................................................. 50.0
Tea, plucked leaves........................................ 30.0
Vegetable, cucurbit, group 9............................... 2.0
Vegetable, fruiting, group 8............................... 2.0
Walnut..................................................... 0.1
------------------------------------------------------------------------
(2) Tolerances for the combined residues of the insecticide
dicofol, 1,1-bis(4-chlorophenyl)-2,2,2-trichloroethanol, 1-(2-
chlorophenyl)-1-(4-chlorophenyl)-2,2,2-trichloroethanol, 1,1-bis(4-
chlorophenyl)-2,2-dichloroethanol, and 1-(2-chlorophenyl)-1-(4-
chlorophenyl)-2,2-dichloroethanol in or on raw agricultural commodities
are established as follows:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Cattle, fat................................................ 50.0
Cattle, liver.............................................. 5.0
Cattle, meat............................................... 3.0
Cattle, meat byproducts, except liver...................... 3.0
Egg........................................................ 0.05
Goat, fat.................................................. 50.0
Goat, liver................................................ 5.0
Goat, meat................................................. 3.0
Goat, meat byproducts, except liver........................ 3.0
Hog, fat................................................... 50.0
Hog, liver................................................. 5.0
Hog, meat.................................................. 3.0
Hog, meat byproducts, except liver......................... 3.0
Horse, fat................................................. 50.0
Horse, liver............................................... 5.0
Horse, meat................................................ 3.0
Horse, meat byproducts, except liver....................... 3.0
Milk, fat (reflecting 0.75 ppm in whole milk).............. 22.0
Poultry, fat............................................... 0.1
Poultry, meat.............................................. 0.1
Poultry, meat byproducts................................... 0.1
Sheep, fat................................................. 50.0
Sheep, liver............................................... 5.0
Sheep, meat................................................ 3.0
Sheep, meat byproducts, except liver....................... 3.0
------------------------------------------------------------------------
* * * * *
0
3. Section 180.191 is amended by revising paragraph (a) and by adding
text to paragraph (c) after the paragraph heading to read as follows:
Sec. 180.191 Folpet; tolerances for residues.
(a) General. Tolerances are established for the fungicide folpet
(N-(trichloromethylthio)phthalimide) in or on raw agricultural
commodities as follows:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Apple\1\................................................ 5.0
Cranberry \1\........................................... 15.0
Cucumber \1\............................................ 2.0
Grape \1\............................................... 50.0
Grape, raisin \1\....................................... 80.0
Hop, dried cones........................................ 120.0
Lettuce \1\............................................. 50.0
Melon \1\............................................... 3.0
Onion, bulb \1\......................................... 2.0
Strawberry \1\.......................................... 5.0
Tomato \1\.............................................. 25.0
------------------------------------------------------------------------
\1\ No U.S. registrations.
* * * * *
(c) Tolerances with regional registration. Tolerances with regional
registrations as defined in Sec. 180.1(m) are established for the
fungicide folpet (N-(trichloromethylthio)phthalimide) in or on the
following raw agricultural commodity:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Avocado.................................................... 25.0
------------------------------------------------------------------------
* * * * *
0
4. Section 180.205 is amended by revising the table in paragraph (a) to
read as follows:
Sec. 180.205 Paraquat; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Acerola.................................................... 0.05
Almond, hulls.............................................. 0.5
Animal feed, nongrass, group 18, forage.................... 75.0
Animal feed, nongrass, group 18, hay....................... 210.0
Artichoke, globe........................................... 0.05
Asparagus.................................................. 0.5
Avocado.................................................... 0.05
Banana..................................................... 0.05
Barley, grain.............................................. 0.05
Barley, hay................................................ 3.5
Barley, straw.............................................. 1.0
Bean, dry, seed............................................ 0.3
Bean, lima, succulent...................................... 0.05
Bean, snap, succulent...................................... 0.05
Beet, sugar................................................ 0.5
Beet, sugar, tops.......................................... 0.05
Berry group 13............................................. 0.05
Cacao bean................................................. 0.05
Carrot, roots.............................................. 0.05
Cattle, fat................................................ 0.05
Cattle, kidney............................................. 0.5
Cattle, meat............................................... 0.05
Cattle, meat byproducts, except kidney..................... 0.05
Coffee, bean, green........................................ 0.05
Corn, field, forage........................................ 3.0
Corn, field, grain......................................... 0.1
Corn, field, stover........................................ 10.0
Corn, pop, grain........................................... 0.1
Corn, pop, stover.......................................... 10.0
Corn, sweet, kernel plus cob with husks removed............ 0.05
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Cotton, gin byproducts..................................... 110.0
Cotton, undelinted seed.................................... 3.5
Cowpea, forage............................................. 0.1
Cowpea, hay................................................ 0.4
Cranberry.................................................. 0.05
Cucurbits.................................................. 0.05
Egg........................................................ 0.01
Endive..................................................... 0.05
Fig........................................................ 0.05
Fruit, citrus, group 10.................................... 0.05
Fruit, pome, group 11...................................... 0.05
Fruit, stone, group 12..................................... 0.05
Ginger..................................................... 0.1
Goat, fat.................................................. 0.05
Goat, kidney............................................... 0.5
Goat, meat................................................. 0.05
Goat, meat byproducts, except kidney....................... 0.05
Grain, aspirated fractions................................. 65.0
Grape...................................................... 0.05
Grass, forage.............................................. 90.0
Grass, hay................................................. 40.0
Guar....................................................... 0.5
Guava...................................................... 0.05
Hog, fat................................................... 0.05
Hog, kidney................................................ 0.5
Hog, meat.................................................. 0.05
Hog, meat byproducts, except kidney........................ 0.05
Hop, dried cones...........................................