[Federal Register: September 27, 2006 (Volume 71, Number 187)]
[Rules and Regulations]
[Page 56392-56399]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27se06-17]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0036; FRL-8089-6]
p-Chlorophenoxyacetic acid, Glyphosate, Difenzoquat, and
Hexazinone; Tolerance Actions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: EPA is revoking certain tolerances for the plant growth
regulator p-chlorophenoxyacetic acid and the herbicide hexazinone.
Also, EPA is modifying certain tolerances for the plant growth
regulator p-chlorophenoxyacetic acid and the herbicides glyphosate,
difenzoquat, and hexazinone. In addition, EPA is establishing new
tolerances for the herbicides difenzoquat and hexazinone.
DATES: This regulation is effective September 27, 2006. Objections and
requests for hearings must be received on or before November 27, 2006,
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-2006-0036. All documents in the
docket are listed in the index for the docket. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business
[[Page 56393]]
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 Bldg.), 2777 S. Crystal Dr., Arlington, VA. The
Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays. The Docket Facility telephone number
is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Jane Smith, Special Review and
Reregistration Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 308-0048; e-mail
address: smith.jane-scott@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 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 FFDCA, as amended by FQPA, any person may
file an objection to any aspect of this regulation and may also request
a hearing on those objections. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. 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-2006-0036 in the subject line on the first page of
your submission. All requests must be in writing, and must be mailed or
delivered to the Hearing Clerk on or before November 27, 2006.
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-2006-0036, 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
Bldg.), 2777 S. Crystal Dr., 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 Facility telephone number is (703) 305-5805.
II. Background
A. What Action is the Agency Taking?
In the Federal Register of June 7, 2006 (71 FR 32899) (FRL-8062-7),
EPA issued a proposed rule to revoke, remove, modify, and establish
certain tolerances and/or tolerance exemptions for residues of the
plant growth regulator p-chlorophenoxyacetic acid and the herbicides
glyphosate, difenzoquat, and hexazinone. The proposal of June 7, 2006
also provided a 60-day comment period which invited public comment for
consideration and for support of tolerance retention under FFDCA
standards.
EPA is revoking, removing, modifying, and establishing specific
tolerances for residues of the plant growth regulator p-
chlorophenoxyacetic acid and the herbicides glyphosate, difenzoquat,
and hexazinone in or on commodities listed in the regulatory text.
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 reregistration and when taking action
on tolerances and exemptions, EPA is required to determine whether each
of the amended tolerances or exemptions meets the safety standards
under FQPA. The safety finding determination of ``reasonable certainty
of no harm'' is found in detail in each RED and TRED for the active
ingredient. REDs and TREDs recommend certain tolerance actions to be
implemented to reflect current use patterns, to meet safety findings,
and change commodity names and groupings in accordance with new EPA
policy. Printed copies of 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 number: 1-800-490-
9198; fax number: 1-513-489-8695; Internet address: http://www.epa.gov/ncepihom
and from the National Technical Information Service (NTIS),
5285 Port Royal Rd., Springfield, VA 22161; telephone number: 1-800-
553-6847 or (703) 605-6000; Internet address: http://www.ntis.gov.
Electronic copies of REDs and TREDs are available on the internet at
http://www.epa.gov/pesticides/reregistration/status.htm.
[[Page 56394]]
In this final rule, EPA is revoking certain tolerances and
tolerance exemptions because these specific tolerances and exemptions
correspond to uses no longer current or registered under Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) in the United
States. The tolerances revoked by this final rule are no longer
necessary to cover residues of the relevant pesticides in or on
domestically treated commodities or commodities treated outside but
imported into the United States. It is EPA's general practice to revoke
those tolerances and tolerance exemptions for residues of pesticide
active ingredients on crop uses for which there are no active
registrations under FIFRA, unless any person in comments on the
proposal indicates a need for the tolerance or tolerance exemption to
cover residues in or on imported commodities or domestic commodities
legally treated.
EPA has historically 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. Thus, it
is EPA's policy to issue a final rule revoking those tolerances for
residues of pesticide chemicals for which there are no active
registrations under FIFRA, unless any person commenting on the proposal
demonstrates a need for the tolerance to cover residues in or on
imported commodities or domestic commodities legally treated.
Generally, EPA will proceed with the revocation of these tolerances
on the grounds discussed in Unit II.A. if one of the following
conditions applies:
-- Prior to EPA's issuance of a FFDCA section 408(f) order
requesting additional data or issuance of a FFDCA 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.
-- EPA independently verifies that the tolerance is no longer
needed.
-- 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 June 7,
2006, EPA received three comments during the 60-day public comment
period, as follows:
Comment. A comment was received from a private citizen
that expressed concern with pesticide residues in general and that
animals should eat quality foods. The individual stated that pesticide
residue levels should be zero.
Agency response. The private citizen's comment did not
take issue with the Agency's conclusion that certain tolerances should
be revoked. It is EPA's general practice to propose revocation of
tolerances for residues of pesticide active ingredients on crop uses
for which FIFRA registrations no longer exist. EPA has historically
been concerned that retention of tolerances that are not necessary to
cover residues in or on legally treated foods may encourage misuse of
pesticides within the United States.
1. Hexazinone.
Comment. A comment was received from DuPont Crop
Protection who requested that the current regional tolerances on
sugarcane, cane and sugarcane molasses in 40 CFR 180.396(c), which
excludes use of hexazinone on sugarcane in Florida, be codified as
general tolerances. The commenter stated that two of DuPont Crop
Protection's registrations for use of hexazinone on sugarcane in
Florida are currently active.
Also, the commenter requested that EPA not revoke the tolerances in
40 CFR 180.396 for fat of cattle, goats, hogs, horses, and sheep, and
meat and meat byproducts of hogs because later this year it will submit
grass residue data to support a revised zero-day forage/grazing
restriction (current labels show a 60-day restriction which is not
considered to be practical by the Agency). The commenter stated that it
expects increased residues warranting a revision of existing tolerances
for both grass and hay as livestock feed commodities.
In addition, the commenter stated that an analysis on current
hexazinone registrations for use on cattle feed commodities conducted
by the Florida Department of Agriculture and Consumer Services in 2005
may show that tolerances for hexazinone on meat, meat byproducts, and
in milk may be exceeded based on a maximum theoretical dietary burden.
Agency response. Since the time of the 2002 hexazinone
TRED, EPA agrees that the Agency did approve two registrations
submitted by DuPont Crop Protection for use of hexazinone on sugarcane
in Florida. Based on these registrations, EPA believes that since there
are no regional sugarcane registrations that specifically exclude
hexazinone use in Florida; therefore, these tolerances need not be
codified as regional. Since this regulatory action was not in the
original Federal Register proposal, recodifying the sugarcane, cane and
sugarcane molasses tolerances from 40 CFR 180.396(c) to (a) as general
tolerances will need to be proposed separately in a future action.
Moreover, in its comment, DuPont Crop Protection did not take issue
with the Agency's proposal to modify the sugarcane tolerances.
Available data indicate combined residues of hexazinone and its
regulated metabolites were < 0.35 parts per million (ppm) in or on
sugarcane. Based on the combined LOQs (0.55 ppm) of the enforcement
method for parent plus metabolites, the Agency determined that the
tolerance for sugarcane, cane should be increased to 0.6 ppm. Also,
based on available sugarcane processing data, the Agency determined
that residues of hexazinone and its metabolites concentrated 32-fold to
final (blackstrap) molasses, the form of molasses typically fed to
livestock. After adjusting for the 2.0x degree of exaggeration used in
the processing study, the Agency determined that while the calculated
residue was greater than the recommended tolerance for the raw
agricultural commodity (sugarcane, cane), it was below the current
tolerance level for sugarcane molasses and should be decreased to 4.0
ppm. Therefore, in 40 CFR 180.396(c) EPA is increasing the tolerance
for combined hexazinone residues of concern in or on sugarcane, cane
from 0.2 to 0.6 ppm and decreasing the tolerance in or on sugarcane
molasses from 5.0 to 4.0 ppm, and revising sugarcane molasses to
sugarcane, molasses. 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.
When EPA proposed to revoke the tolerances in 40 CFR 180.396 for
fat of cattle, goats, hogs, horses, and sheep, and meat and meat
byproducts of hogs, it did so based on available exaggerated feeding
data from which the Agency determined that there is no reasonable
expectation of finite hexazinone residues of concern in livestock from
treated feed. However, because DuPont Crop Protection will submit new
data later this year and information from the State of Florida may need
to be considered by the Agency, EPA will not revoke these specific fat,
meat, and meat byproduct tolerances at this time. When the information
from the State of Florida and submitted data from DuPont Crop
Protection have been reviewed, EPA will re-evaluate these tolerances
under FFDCA. If data are not submitted in the near future or if data
adequate to support a safety finding are lacking, EPA intends to revoke
the tolerances on
[[Page 56395]]
cattle, fat; sheep, fat; hog, meat; and hog, meat byproducts in 40 CFR
180.396.
The TRED mentions the need for additional method validation of
Method AMR 3783-6 for determining hexazinone (parent and metabolite)
levels in milk and livestock tissues. The method has undergone
successful independent validation and radiovalidation studies.
Additional validation by EPA laboratories is not required. The method
is considered adequate for enforcement purposes for residues of
hexazinone (and metabolites) in milk and livestock tissues.
According to the TRED, the tolerance expression, which is currently
expressed as hexazinone and its metabolites (calculated as hexazinone)
in 40 CFR 180.396(a) for plant, animal, and milk commodities for
general tolerances should be modified to include all the specific
metabolites in plants, animal tissue and milk. Consequently, EPA is
separating and recodifying plant, animal, and milk tolerances from 40
CFR 180.396(a) to (a)(1), (a)(2), and (a)(3), respectively. In the
Federal Register proposal of June 7, 2006, the C-1 metabolite was
inadvertently included in 40 CFR 180.396(a)(3).
After correction of the exaggerated feeding dose (62.5x) for
cattle, goats, horses, and sheep, the Agency determined that residue
levels of hexazinone and its metabolites ranged as high as 0.09 ppm
(just below the sum of the LOQs or 0.1 ppm), and therefore meat and
meat byproduct tolerances should be maintained in newly recodified 40
CFR 180.396(a)(2) at 0.1 ppm for cattle, goats, horses, and sheep.
In addition, after correction of the exaggerated feeding dose
(62.5x) for cattle, the Agency determined that residue levels of
hexazinone and its metabolites in whole milk ranged as high as 0.164
ppm. Based on the enforcement method, the sum of the combined LOQs for
hexazinone and its metabolites, EPA is increasing the tolerance in the
newly recodified 40 CFR 180.396(a)(3) for the combined hexazinone
residues of concern in or on milk from 0.1 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.
Available data indicate combined residues of hexazinone and its
regulated metabolites were < 0.3 ppm in or on blueberries and < 0.35 ppm
in or on pineapples. Based on the combined LOQs (0.55 ppm) of the
enforcement method for parent plus metabolites, EPA is increasing the
tolerances in newly recodified 40 CFR 180.396(a)(1) for combined
hexazinone residues of concern in or on blueberry from 0.2 to 0.6 ppm
and pineapple (whole fruit) from 0.5 to 0.6 ppm, and revising pineapple
(whole fruit) to pineapple. 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 data that indicate combined residues of
hexazinone and its regulated metabolites as high as 1.46 ppm in or on
alfalfa seed, the Agency determined that a tolerance should be
established at 2.0 ppm. Therefore, EPA is establishing a tolerance in
newly recodified 40 CFR 180.396(a)(1) for combined hexazinone residues
of concern in or on alfalfa, seed at 2.0 ppm.
In addition, EPA is revising commodity terminology in 40 CFR
180.396(a) to conform to current Agency practice as follows: alfalfa
green forage to alfalfa, forage; grass, range and grass, pasture to
grass, forage, and grass, hay.
2. Glyphosate.
Comment. A comment was received from Monsanto Company
generally agreeing with the proposed tolerance changes to glyphosate in
40 CFR 180.364. Monsanto also wanted to alert the Agency of the recent
changes in the CODEX Maximum Residue Limits (MRLs) for glyphosate
finalized by the CODEX Alimentarious Commission in July of 2006.
Monsanto provided a detailed list of suggested changes to the U.S.
tolerance regulation for glyphosate (concerning cereal, grains, cotton
seed, meat byproducts, kiwifruit, and rapeseed) to achieve better
alignment with the newly established CODEX MRLs. Monsanto did note two
modifications that should be made in 40 CFR 180.364:
--To alphabetize the commodity cacao beans.
--Add the term ``except corn forage'' to the Crop group 16 forage,
fodder, and straw tolerance to eliminate a conflict with the individual
tolerance for ``corn, field, forage''.
Agency response. The Agency appreciates the support of
Monsanto and the alert concerning the changes in the CODEX MRLs. Since
the CODEX MRLs were adopted during the comment period of the proposal,
any tolerance modifications made in attempt to harmonize with CODEX
will need to be proposed separately for comment. The Agency will
address the CODEX harmonization in a future proposal and consider
Monsanto's detailed recommendations for CODEX harmonization of
tolerances for glyphosate at that time. Consequently, the Agency is not
taking action on the tolerances in 40 CFR 180.364 on kiwifruit, and
cattle and hog liver as proposed. EPA agrees with alphabetizing cacao
bean and revising the crop group 16 to include the term ``except corn
forage'' in 40 CFR 180.364.
EPA is revising commodity terminology in 40 CFR 180.364 to conform
to current Agency practice as follows: Hop, dried cone to hop, dried
cones; wheat, milling fractions, (except flour) to wheat, bran; wheat,
middlings; and wheat, shorts; grain, cereal, stover and straw, group to
grain, cereal, forage, fodder and straw, group 16, except corn forage;
vegetable, bulb, group to vegetable, bulb, group 3; vegetable, foliage
of legume except soybean, subgroup 7A to vegetable, foliage of legume,
subgroup 7A, except soybean; vegetable, fruiting, group to vegetable,
fruiting, group 8; vegetable, leafy, group to vegetable, leafy, group
4; and vegetable, leaves of root and tuber, group (except sugar beet
tops) to vegetable, leaves of root and tuber, group 2, except sugar
beet tops.
The RED recommended that alfalfa (fresh and hay), clover and other
non-grass animal feeds be consolidated in the corresponding crop group
``animal feed, nongrass, group 18'' at 100 ppm. Since the RED was
published, the ``animal feed, nongrass, group 18'' was established;
however, due to changes in the use patterns and grazing intervals the
corresponding tolerance level is 400 ppm. Also, the existing and
conflicting tolerances for ``alfalfa, hay'' (400 ppm) and ``alfalfa,
forage'' (175 ppm), respectively, should be removed since the existing
tolerance on ``animal feed, nongrass, group 18'' (400 ppm) covers these
animal feed items. This was originally proposed by the EPA June 18,
2003 (68 FR 36472) (FRL-7308-8). Therefore, EPA is removing the
tolerances in 40 CFR 180.364 on alfalfa, forage at 175 ppm and alfalfa,
hay at 400 ppm, because they are no longer needed and their commodity
uses are covered by the existing group tolerance.
No comments were received by the Agency concerning the following.
3. p-Chlorophenoxyacetic acid. The Agency canceled the last
registered use for p-chlorophenoxyacetic acid on tomato in May 1995.
Therefore, the Agency is revoking the tolerance in 40 CFR 180.202(a)(1)
for combined residues of the plant regulator p-chlorophenoxyacetic acid
and its metabolite p-chlorophenol in or on tomato, removing paragraph
(a)(1), and recodifying existing paragraph (a)(2) as paragraph (a).
[[Page 56396]]
Based on the available data that indicate combined residues of p-
chlorophenoxyacetic acid and its metabolite p-chlorophenol in or on
mung bean sprouts will not exceed 0.2 ppm, the Agency determined that
the tolerance should be lowered to 0.2 ppm. Therefore, EPA is
decreasing the tolerance for combined residues of the plant regulator
p-chlorophenoxyacetic acid and its metabolite p-chlorophenol to inhibit
embryonic root development in or on bean, mung, sprouts from 2.0 to 0.2
ppm in newly recodified 40 CFR 180.202(a).
4. Difenzoquat. Based on available field trial data that indicate
residues of difenzoquat were non-detectable (< 0.05 ppm) in or on barley
grain, as high as 4.0 ppm in or on barley straw, and as high as 4.2 ppm
in or on wheat straw, the Agency determined that these tolerances
should be decreased to 0.05 ppm, 5.0 ppm, and 5.0 ppm, respectively.
Therefore, EPA is decreasing the tolerance in 40 CFR 180.369 for
residues of difenzoquat in or on barley, grain from 0.2 to 0.05 ppm;
barley straw from 20.0 to 5.0 ppm; and wheat, straw from 20.0 to 5.0
ppm.
Processing data for wheat grain and aspirated grain fractions
indicate that residues of difenzoquat concentrated 4-fold in wheat bran
and 4.6-fold in shorts, and minimal concentration occurred in
middlings. Residues did not concentrate in flour. The wheat processing
data are also applicable to barley. Based on those concentration
factors and the reassessed tolerance of 0.05 ppm for wheat grain, the
Agency determined that tolerances for both wheat bran and shorts should
be established at 0.25 ppm. Therefore, EPA is establishing tolerances
in 40 CFR 180.369 at 0.25 ppm for residues of difenzoquat in or on
wheat, bran and wheat, shorts. In addition, because the wheat
processing data are translated to barley, EPA is establishing a
tolerance in 40 CFR 180.369 for residues of difenzoquat in or on
barley, bran at 0.25 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
FQPA. The safety finding determination is found in detail in each 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 TREDs for p-chlorophenoxyacetic acid, difenzoquat,
and hexazinone. Glyphosate tolerances were reassessed post-FQPA as part
of the Agency's determinations on April 11, 1997 (62 FR 17723) to
establish new glyphosate uses and therefore a TRED to reassess its
tolerances was not needed. All of these active ingredients had REDs
which were completed prior to FQPA. 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
FQPA 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. 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 on the date of publication of this
final rule in the Federal Register because their associated uses have
been canceled for several years. The Agency believes 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 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 both:
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.
2. The residue does not exceed the level that was authorized at the
time of the application or use to be present on the food under a
tolerance or exemption from tolerance. Evidence to show that food was
lawfully treated may include records that verify the dates that the
pesticide was applied to such food.
III. Are There Any International Trade Issues Raised by this Final
Action?
EPA considers CODEX MRLs in setting U.S. tolerances and in
reassessing them. MRLs are established by the CODEX Committee on
Pesticide Residues, a committee within the CODEX Alimentarius
Commission, an international organization formed to promote the
coordination of international food standards. When possible, EPA seeks
to harmonize U.S. tolerances with CODEX MRLs. EPA may establish a
tolerance that is different from a CODEX MRL; however, FFDCA section
408(b)(4) requires that EPA explain in a Federal Register document the
reasons for departing from the CODEX level. EPA's effort to harmonize
with CODEX MRLs is summarized in
[[Page 56397]]
the tolerance reassessment section of individual REDs. EPA has
developed guidance concerning submissions for import tolerance support
(65 FR 35069, June 1, 2000) (FRL-6559-3). This guidance will be made
available to interested persons. Electronic copies are available on the
Internet at http://www.epa.gov. On the EPA Home Page select ``Laws,
Regulations & Dockets,'' then select ``Regulations and Proposed Rules''
and then look up the entry for this document under ``Federal Register--
Environmental Documents.'' You can also go directly to the ``Federal
Register'' listings at http://www.epa.gov/fedrgstr.
IV. Statutory and Executive Order Reviews
In this 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, entitled 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 final 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 for this final rule). 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., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule ''as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
[[Page 56398]]
Dated: September 20, 2006.
James J. Jones,
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. In Sec. 180.202, paragraph (a) is revised to read as follows:
Sec. 180.202 p-Chlorophenoxyacetic acid; tolerances for residues.
(a) General. A tolerance is established for the combined residues
of the plant regulator p-chlorophenoxyacetic acid and its metabolite p-
chlorophenol to inhibit embryonic root development in or on the
following food commodity:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Bean, mung, sprouts........................................ 0.2
------------------------------------------------------------------------
* * * * *
0
3. In Sec. 180.364, the table in paragraph (a) is revised to read as
follows:
Sec. 180.364 Glyphosate; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Acerola.................................................... 0.2
Alfalfa, seed.............................................. 0.5
Almond, hulls.............................................. 25
Aloe vera.................................................. 0.5
Ambarella.................................................. 0.2
Animal feed, nongrass, group 18............................ 400
Artichoke, globe........................................... 0.2
Asparagus.................................................. 0.5
Atemoya.................................................... 0.2
Avocado.................................................... 0.2
Bamboo, shoots............................................. 0.2
Banana..................................................... 0.2
Barley, bran............................................... 30
Barley, grain.............................................. 20
Beet, sugar, dried pulp.................................... 25
Beet, sugar, roots......................................... 10
Beet, sugar, tops.......................................... 10
Berry, group 13............................................ 0.2
Betelnut................................................... 1.0
Biriba..................................................... 0.2
Blimbe..................................................... 0.2
Borage, seed............................................... 0.1
Breadfruit................................................. 0.2
Cacao bean................................................. 0.2
Cactus, fruit.............................................. 0.5
Cactus, pads............................................... 0.5
Canistel................................................... 0.2
Canola, meal............................................... 15
Canola, seed............................................... 10
Cattle, kidney............................................. 4.0
Cattle, liver.............................................. 0.5
Chaya...................................................... 1.0
Cherimoya.................................................. 0.2
Citrus, dried pulp......................................... 1.5
Coconut.................................................... 0.1
Coffee, bean............................................... 1.0
Corn, field, forage........................................ 6.0
Corn, field, grain......................................... 1.0
Cotton, gin byproducts..................................... 175
Cotton, undelinted seed.................................... 35
Cranberry.................................................. 0.2
Crambe, seed............................................... 0.1
Custard apple.............................................. 0.2
Date....................................................... 0.2
Dokudami................................................... 2.0
Durian..................................................... 0.2
Egg........................................................ 0.05
Epazote.................................................... 1.3
Feijoa..................................................... 0.2
Fig........................................................ 0.2
Fish....................................................... 0.25
Flax, meal................................................. 8.0
Flax, seed................................................. 4.0
Fruit, citrus, group 10.................................... 0.5
Fruit, pome, group 11...................................... 0.2
Fruit, stone, group 12..................................... 0.2
Galangal, root............................................. 0.2
Ginger, white, flower...................................... 0.2
Goat, kidney............................................... 4.0
Goat, liver................................................ 0.5
Gourd, buffalo, seed....................................... 0.1
Governor's plum............................................ 0.2
Gow kee, leaves............................................ 0.2
Grain, aspirated fractions................................. 100
Grain, cereal, forage, fodder and straw, group 16, except 100
corn forage...............................................
Grain, cereal, group 15, except barley, field corn, grain 0.1
sorghum, oat and wheat....................................
Grape...................................................... 0.2
Grass, forage, fodder and hay, group 17.................... 300
Guava...................................................... 0.2
Herbs subgroup 19A......................................... 0.2
Hog, kidney................................................ 4.0
Hog, liver................................................. 0.5
Hop, dried cones........................................... 7.0
Horse, kidney.............................................. 4.0
Horse, liver............................................... 0.5
Ilama...................................................... 0.2
Imbe....................................................... 0.2
Imbu....................................................... 0.2
Jackfruit.................................................. 0.2
Jaboticaba................................................. 0.2
Jojoba, seed............................................... 0.1
Juneberry.................................................. 0.2
Kava, roots................................................ 0.2
Kenaf, forage.............................................. 200
Kiwifruit.................................................. 0.2
Lesquerella, seed.......................................... 0.1
Leucaena, forage........................................... 200
Lingonberry................................................ 0.2
Longan..................................................... 0.2
Lychee..................................................... 0.2
Mamey apple................................................ 0.2
Mango...................................................... 0.2
Mangosteen................................................. 0.2
Marmaladebox............................................... 0.2
Meadowfoam, seed........................................... 0.1
Mioga, flower.............................................. 0.2
Mustard, seed.............................................. 0.1
Nut, pine.................................................. 1.0
Nut, tree, group 14........................................ 1.0
Oat, grain................................................. 20
Okra....................................................... 0.5
Olive...................................................... 0.2
Oregano, Mexican, leaves................................... 2.0
Palm heart................................................. 0.2
Palm heart, leaves......................................... 0.2
Palm, oil.................................................. 0.1
Papaya..................................................... 0.2
Papaya, mountain........................................... 0.2
Passionfruit............................................... 0.2
Pawpaw..................................................... 0.2
Peanut..................................................... 0.1
Peanut, forage............................................. 0.5
Peanut, hay................................................ 0.5
Pepper leaf, fresh leaves.................................. 0.2
Peppermint, tops........................................... 200
Perilla, tops.............................................. 1.8
Persimmon.................................................. 0.2
Pineapple.................................................. 0.1
Pistachio.................................................. 1.0
Pomegranate................................................ 0.2
Poultry, meat.............................................. 0.1
Poultry, meat byproducts................................... 1.0
Pulasan.................................................... 0.2
Quinoa, grain.............................................. 5.0
Rambutan................................................... 0.2
Rapeseed, meal............................................. 15
Rapeseed, seed............................................. 10
Rose apple................................................. 0.2
Safflower, seed............................................ 0.1
Salal...................................................... 0.2
Sapodilla.................................................. 0.2
Sapote, black.............................................. 0.2
Sapote, mamey.............................................. 0.2
Sapote, white.............................................. 0.2
Sesame, seed............................................... 0.1
Sheep, kidney.............................................. 4.0
Sheep, liver............................................... 0.5
Shellfish.................................................. 3.0
Sorghum, grain, grain...................................... 15
Soursop.................................................... 0.2
Soybean, forage............................................ 100
Soybean, hay............................................... 200
Soybean, hulls............................................. 100
Soybean, seed.............................................. 20
Spanish lime............................................... 0.2
Spearmint, tops............................................ 200
Spice subgroup 19B......................................... 7.0
Star apple................................................. 0.2
Starfruit.................................................. 0.2
Stevia, dried leaves....................................... 1.0
Strawberry................................................. 0.2
Sugar apple................................................ 0.2
Sugarcane, cane............................................ 2.0
Sugarcane, molasses........................................ 30
Sunflower, seed............................................ 0.1
Surinam cherry............................................. 0.2
Tamarind................................................... 0.2
Tea, dried................................................. 1.0
Tea, instant............................................... 7.0
Teff, grain................................................ 5.0
Ti, leaves................................................. 0.2
Ti, roots.................................................. 0.2
Ugli fruit................................................. 0.5
Vegetable, leafy, brassica, group 5........................ 0.2
Vegetable, bulb, group 3................................... 0.2
Vegetable, cucurbit, group 9............................... 0.5
Vegetable, foliage of legume, subgroup 7A, except soybean.. 0.2
Vegetable, fruiting, group 8............................... 0.1
Vegetable, leafy, group 4.................................. 0.2
Vegetable, leaves of root and tuber, group 2, except sugar 0.2
beet tops.................................................
[[Page 56399]]
Vegetable, legume, group 6, except soybean................. 5.0
Vegetable, root and tuber, group 1, except sugar beet...... 0.2
Wasabi, roots.............................................. 0.2
Water spinach, tops........................................ 0.2
Watercress, upland......................................... 0.2
Wax jambu.................................................. 0.2
Wheat, bran................................................ 20
Wheat, grain............................................... 5.0
Wheat, middlings........................................... 20
Wheat, shorts.............................................. 20
Yacon, tuber............................................... 0.2
------------------------------------------------------------------------
* * * * *
0
4. Section 180.369 is revised as follows:
Sec. 180.369 Difenzoquat; tolerances for residues.
(a) General. Tolerances are established for residues of difenzoquat
(1,2-dimethyl-3,5-diphenyl-1H-pyrazolium ion), derived from application
of the methyl sulfate salt and calculated as the cation, in or on the
following raw agricultural commodities:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Barley, bran............................................... 0.25
Barley, grain.............................................. 0.05
Barley, straw.............................................. 5.0
Cattle, fat................................................ 0.05
Cattle, meat............................................... 0.05
Cattle, meat byproducts.................................... 0.05
Goat, fat.................................................. 0.05
Goat, meat................................................. 0.05
Goat, meat byproducts...................................... 0.05
Hog, fat................................................... 0.05
Hog, meat.................................................. 0.05
Hog, meat byproducts....................................... 0.05
Horse, fat................................................. 0.05
Horse, meat................................................ 0.05
Horse, meat byproducts..................................... 0.05
Poultry, fat............................................... 0.05
Poultry, meat.............................................. 0.05
Poultry, meat byproducts................................... 0.05
Sheep, fat................................................. 0.05
Sheep, meat................................................ 0.05
Sheep, meat byproducts..................................... 0.05
Wheat, bran................................................ 0.25
Wheat, grain............................................... 0.05
Wheat, shorts.............................................. 0.25
Wheat, straw............................................... 5.0
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
0
5. In Sec. 180.396, paragraphs (a) and (c) are revised to read as
follows:
Sec. 180.396 Hexazinone; tolerances for residues.
(a) General. (1) Tolerances are established for the combined
residues of hexazinone (3-cyclohexyl-6-(dimethylamino)-1-methyl-1,3,5-
triazine-2,4-(1H,3H)-dione) and its plant metabolites; A [3-(4-
hydroxycyclohexyl)-6-(dimethylamino)-1-methyl-1,3,5-triazine-2,4-
(1H,3H)-dione], B [3-cyclohexyl-6-(methylamino)-1-methyl-1,3,5-
triazine-2,4-(1H,3H)-dione], C [3-(4-hydroxycyclohexyl)-6-
(methylamino)-1-methyl-1,3,5-triazine-2,4-(1H,3H)-dione], D [3-
cyclohexyl)-1-methyl-1,3,5-triazine-2,4,6-(1H,3H,5H)-trione], and E [3-
(4-hydroxycyclohexyl)-1-methyl-1,3,5-triazine-2,4,6-(1H,3H,5H)-trione]
(calculated as hexazinone) in the following commodities:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Alfalfa, forage............................................ 2.0
Alfalfa, hay............................................... 8.0
Alfalfa, seed.............................................. 2.0
Blueberry.................................................. 0.6
Grass, forage.............................................. 10.0
Pineapple.................................................. 0.6
------------------------------------------------------------------------
(2) Tolerances are established for the combined residues of
hexazinone (3-cyclohexyl-6-(dimethylamino)-1-methyl-1,3,5-triazine-2,4-
(1H,3H)-dione) and its animal tissue metabolites; B [3-cyclohexyl-6-
(methylamino)-1-methyl-1,3,5-triazine-2,4-(1H,3H)-dione], and F (3-
cyclohexyl-6-amino-1-methyl-1,3,5-triazine-2,4-(1H,3H)-dione)
(calculated as hexazinone) in the following food commodities:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Cattle, fat................................................ 0.1
Cattle, meat............................................... 0.1
Cattle, meat byproducts.................................... 0.1
Goat, fat.................................................. 0.1
Goat, meat................................................. 0.1
Goat, meat byproducts...................................... 0.1
Hog, fat................................................... 0.1
Hog, meat.................................................. 0.1
Hog, meat byproducts....................................... 0.1
Horse, fat................................................. 0.1
Horse, meat................................................ 0.1
Horse, meat byproducts..................................... 0.1
Sheep, fat................................................. 0.1
Sheep, meat................................................ 0.1
Sheep, meat byproducts..................................... 0.1
------------------------------------------------------------------------
(3) Tolerances are established for the combined residues of
hexazinone (3-cyclohexyl-6-(dimethylamino)-1-methyl-1,3,5-triazine-2,4-
(1H,3H)-dione) and its metabolites; B [3-cyclohexyl-6-(methylamino)-1-
methyl-1,3,5-triazine-2,4-(1H,3H)-dione], C [3-(4-hydroxycyclohexyl)-6-
(methylamino)-1-methyl-1,3,5-triazine-2,4-(1H,3H)-dione], C-2 [3-(3-
hydroxycyclohexyl)-6-(methylamino)-1-methyl-1,3,5-triazine-2,4-(1H,3H)-
dione] and F (3-cyclohexyl-6-amino-1-methyl-1,3,5-triazine-2,4-(1H,3H)-
dione) (calculated as hexazinone) in milk:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Milk....................................................... 0.2
------------------------------------------------------------------------
(c) Tolerances with regional registrations. Tolerances with
regional registration, as defined in Sec. 180.1(n) and which excludes
use of hexazinone on sugarcane in Florida, are established for the
combined residues of hexazinone (3-cyclohexyl-6-(dimethylamino)-1-
methyl-1,3,5-triazine-2,4-(1H,3H)-dione and its plant metabolites; A
[3-(4-hydroxycyclohexyl)-6-(dimethylamino)-1-methyl-1,3,5-triazine-
2,4(1H,3H)-dione], B [3-cyclohexyl-6-(methylamino)-1-methyl-1,3,5-
triazine-2,4-(1H,3H)-dione], C [3-(4-hydroxycyclohexyl)-6-
(methylamino)-1-methyl-1,3,5-triazine-2,4-(1H,3H)-dione], D [(3-
cyclohexyl)-1-methyl-1,3,5-triazine-2,4,6-(1H,3H,5H)-trione], and E [3-
(4-hydroxycyclohexyl)-1-methyl-1,3,5-triazine-2,4,6-(1H,3H,5H)-trione]
(calculated as hexazinone) in the following commodities:
------------------------------------------------------------------------
Parts per
Commodity milliom
------------------------------------------------------------------------
Sugarcane, cane............................................ 0.6
Sugarcane, molasses........................................ 4.0
------------------------------------------------------------------------
[FR Doc. E6-15840 Filed 9-26-06; 8:45 am]
BILLING CODE 6560-50-S