p-Chlorophenoxyacetic acid, Glyphosate, Difenzoquat, and Hexazinone; Proposed Tolerance Actions, 32899-32909 [E6-8827]
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Federal Register / Vol. 71, No. 109 / Wednesday, June 7, 2006 / Proposed Rules
[FR Doc. E6–8826 Filed 6–6–06; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2006–0036; FRL–8062–7]
p-Chlorophenoxyacetic acid,
Glyphosate, Difenzoquat, and
Hexazinone; Proposed Tolerance
Actions
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
rwilkins on PROD1PC63 with PROPOSAL
AGENCY:
SUMMARY: EPA is proposing to revoke
certain tolerances for the plant growth
regulator p-chlorophenoxyacetic acid
and the herbicide hexazinone. Also,
EPA is proposing to modify certain
tolerances for the plant growth regulator
p-chlorophenoxyacetic acid and the
herbicides glyphosate, difenzoquat, and
hexazinone. In addition, EPA is
proposing to establish new tolerances
for the herbicides difenzoquat and
hexazinone. The regulatory actions
proposed in this document are part of
the Agency’s reregistration program
under the Federal Insecticide,
Fungicide, and Rodenticide Act
(FIFRA), and the tolerance reassessment
requirements of the Federal Food, Drug,
and Cosmetic Act (FFDCA) section
408(q), as amended by the Food Quality
Protection Act (FQPA) of 1996. By law,
EPA is required by August 2006 to
reassess the tolerances that were in
existence on August 2, 1996. No
tolerance reassessments will be counted
at the time of a final rule because
tolerances in existence on August 2,
1996 that are associated with actions
proposed herein were previously
counted as reassessed at the time of the
completed Reregistration Eligibility
Decision (RED), Report of the FQPA
Tolerance Reassessment Progress and
Risk Management Decision (TRED), or
Federal Register action.
DATES: Comments must be received on
or before August 7, 2006.
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
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
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available only in hard copy form.
Publicly available docket materials are
available in the electronic docket at
https://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: 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; email 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).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
This listing is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. To determine whether
you or your business may be affected by
this action, you should carefully
examine the applicability provisions in
Unit IIA. If you have any questions
regarding the applicability of this action
to a particular entity, consult the person
listed under FOR FURTHER INFORMATION
CONTACT.
B. What Should I Consider as I Prepare
My Comments for EPA?
1. Submitting CBI. Do not submit this
information to EPA through
regulations.gov or e-mail. Clearly mark
the part or all of the information that
you claim to be CBI. For CBI
information in a disk or CD ROM that
you mail to EPA, mark the outside of the
disk or CD ROM as CBI and then
identify electronically within the disk or
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CD ROM the specific information that is
claimed as CBI. In addition to one
complete version of the comment that
includes information claimed as CBI, a
copy of the comment that does not
contain the information claimed as CBI
must be submitted for inclusion in the
public docket. Information so marked
will not be disclosed except in
accordance with procedures set forth in
40 CFR part 2.
2. Tips for preparing your comments.
When submitting comments, remember
to:
i. Identify the document by docket ID
number and other identifying
information (subject heading, Federal
Register date and page number).
ii. Follow directions. The Agency may
ask you to respond to specific questions
or organize comments by referencing a
Code of Federal Regulations (CFR) part
or section number.
iii. Explain why you agree or disagree;
suggest alternatives and substitute
language for your requested changes.
iv. Describe any assumptions and
provide any technical information and/
or data that you used.
v. If you estimate potential costs or
burdens, explain how you arrived at
your estimate in sufficient detail to
allow for it to be reproduced.
vi. Provide specific examples to
illustrate your concerns and suggest
alternatives.
vii. Explain your views as clearly as
possible, avoiding the use of profanity
or personal threats.
viii. Make sure to submit your
comments by the comment period
deadline identified.
C. What Can I do if I Wish the Agency
to Maintain a Tolerance that the Agency
Proposes to Revoke?
This proposed rule provides a
comment period of 60 days for any
person to state an interest in retaining
a tolerance proposed for revocation. If
EPA receives a comment within the 60–
day period to that effect, EPA will not
proceed to revoke the tolerance
immediately. However, EPA will take
steps to ensure the submission of any
needed supporting data and will issue
an order in the Federal Register under
FFDCA section 408(f) if needed. The
order would specify data needed and
the time frames for its submission, and
would require that within 90 days some
person or persons notify EPA that they
will submit the data. If the data are not
submitted as required in the order, EPA
will take appropriate action under
FFDCA.
EPA issues a final rule after
considering comments that are
submitted in response to this proposed
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rule. In addition to submitting
comments in response to this proposal,
you may also submit an objection at the
time of the final rule. If you fail to file
an objection to the final rule within the
time period specified, you will have
waived the right to raise any issues
resolved in the final rule. After the
specified time, issues resolved in the
final rule cannot be raised again in any
subsequent proceedings.
II. Background
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A. What Action is the Agency Taking?
EPA is proposing to revoke, remove,
modify, and establish 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 proposing these tolerance
actions 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 FQPA.
The safety finding determination of
‘‘reasonable certainty of no harm’’ is
discussed in detail in each RED and
report of the 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, 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, P.O. Box
42419, Cincinnati, OH 45242–2419,
telephone 1–00–490–9198; fax 1–513–
489–8695; internet at https://
www.epa.gov/ncepihom/ and from the
National Technical Information Service,
5285 Port Royal Road, Springfield, VA
22161, telephone 1–800–553–6847 or
703–605–6000; internet at https://
www.ntis.gov/. Electronic copies of
REDs and TREDs are available on the
internet for glyphosate at https://
www.epa.gov/pesticides/reregistration/
status.htm, and p-chlorophenoxyacetic
acid, difenzoquat, and hexazinone in
public dockets EPA–HQ–OPP–2003–
0124, EPA–HQ–OPP–2002–0097, and
EPA–HQ–OPP–2002–0188, respectively,
at https://www.regulations.gov.
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The selection of an individual
tolerance level is based on crop field
residue studies designed to produce the
maximum residues under the existing or
proposed product label. Generally, the
level selected for a tolerance is a value
slightly above the maximum residue
found in such studies. The evaluation of
whether a tolerance is safe is a separate
inquiry. EPA recommends the raising of
a tolerance when data show that (1)
lawful use (sometimes through a label
change) may result in a higher residue
level on the commodity, and (2) the
tolerance remains safe, notwithstanding
increased residue level allowed under
the tolerance. In REDs, Chapter IV on
‘‘Risk management, Reregistration, and
Tolerance Reassessment’’ typically
describes the regulatory position, FQPA
assessment, cumulative safety
determination, determination of safety
for U.S. general population, and safety
for infants and children. In particular,
the human health risk assessment
document which supports the RED
describes risk exposure estimates and
whether the Agency has concerns. In
TREDs, the Agency discusses its
evaluation of the dietary risk associated
with the active ingredient and whether
it can determine that there is a
reasonable certainty (with appropriate
mitigation) that no harm to any
population subgroup will result from
aggregate exposure.
Explanations for proposed
modifications in tolerances can be
found in the RED and TRED document
and in more detail in the Residue
Chemistry Chapter document which
supports the RED and TRED. Copies of
the Residue Chemistry Chapter
documents are found in the
Administrative Record and paper copies
for difenzoquat and hexazinone can be
found under their respective public
docket numbers, identified above. Paper
copies for p-chlorophenoxyacetic acid
and glyphosate are available in the
public docket for this rule. Electronic
copies are available through EPA’s
electronic public docket and comment
system, regulations.gov at https://
www.regulations.gov/. You may search
for this rule under docket number EPA–
HQ–OPP–2006–0036, or for an
individual chemical under its respective
docket number, then click on that
docket number to view its contents.
The aggregate exposures and risks are
not of concern for the above mentioned
pesticide active ingredients based upon
the data identified in the RED or TRED
which lists the submitted studies that
the Agency found acceptable.
EPA has found that the tolerances that
are proposed in this document to be
established or modified, are safe, i.e.,
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that there is a reasonable certainty that
no harm will result to infants and
children from aggregate exposure to the
pesticide chemical residues, in
accordance with section 408(b)(2)(C).
(Note that changes to tolerance
nomenclature do not constitute
modifications of tolerances). These
findings are discussed in detail in each
RED or TRED. The references are
available for inspection as described in
this document under SUPPLEMENTARY
INFORMATION.
In addition, EPA is proposing to
revoke certain specific tolerances
because either they are no longer
needed or are associated with food uses
that are no longer registered under
FIFRA. Those instances where
registrations were canceled were
because the registrant failed to pay the
required maintenance fee and/or the
registrant voluntarily canceled one or
more registered uses of the pesticide. It
is EPA’s general practice to propose
revocation of those tolerances for
residues of pesticide active ingredients
on crop uses for which there are no
active registrations under FIFRA, unless
any person in comments on the
proposal indicates a need for the
tolerance to cover residues in or on
imported commodities or domestic
commodities legally treated.
1. p-Chlorophenoxyacetic acid. The
Agency canceled the last registered uses
for p-chlorophenoxyacetic acid on
tomato in May 1995. Therefore, the
Agency is proposing to revoke 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, remove paragraph (a)(1), and
recodify existing paragraph (a)(2) as
paragraph (a).
Based on the available data that
indicate combined residues of pchlorophenoxyacetic 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 proposing to decrease
the tolerance for combined residues of
the plant regulator pchlorophenoxyacetic 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).
2. Glyphosate. A RED was completed
on glyphosate in September 1993 before
the passage of the FQPA. On April 11,
1997 (62 FR 17723) (FRL–5598–6) EPA
published a notice in the Federal
Register which established new uses for
glyphosate. Existing tolerances for
glyphosate in 40 CFR 180.364 were
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considered by the Agency to be
reassessed at that time. Although the
glyphosate RED recommended
revocation of tolerances based on no
registered uses for the following food
commodities; bread fruit, canistel,
cherimoya, cacao bean, date,
marmaladebox (formerly genip),
jaboticaba, jackfruit, persimmon, sapote
(black and white), soursop, and
tamarind at 0.2 ppm and coconut at 0.1
ppm; these food uses are currently
active and have existed for years since
the RED. Canistel, cacao bean, jackfruit,
and sapote have existed since 2003;
bread fruit, cherimoya, marmaladebox,
jaboticaba, soursop, and tamarind since
2000, and persimmon and dates since
1998. Therefore, EPA will maintain
these tolerances in 40 CFR 180.364.
Data on glyphosate residues in or on
both tea leaves and instant tea were
available at the time of the RED.
Nevertheless, instant tea was also
recommended for revocation in the RED
because the Agency at that time did not
consider it to be a significant item in the
daily dietary risk assessment of the
population of the United States from
pesticide use on that processed
commodity. However, instant tea is now
considered to be a processed commodity
according to the ‘‘Table 1.—Raw
Agricultural and Processed
Commodities and Feedstuffs Derived
from Crops’’ which is found in Residue
Chemistry Test Guidelines OPPTS
860.1000 dated August 1996, available
at https://www.epa.gov/opptsfrs/
publications/OPPTS_Harmonized/
860_Residue_Chemistry_
Test_Guidelines/Series/. As stated
above, existing tolerances for glyphosate
in 40 CFR 180.364, including instant
tea, were reassessed at the time of new
use approvals on (April 11, 1997, 62 FR
17723). Therefore, EPA will maintain
the tolerance on ‘‘tea, instant’’ in 40 CFR
180.364.
In the RED, it was recommended that
tolerances be established for potato
chips, granules, flakes and processed
potato waste; however, the quality of the
data for potato chips, granules and
processed potato waste was in question.
In 1996 new residue data on potatoes
and processed potato foods and feeds
were provided to the Agency. These
data indicated that at the 10x rate
residues were <0.01 ppm glyphosate in
or on fresh potato chips, dry peel, and
wet peel; and 0.02 - 0.049 ppm
glyphosate on fresh flakes. Based on
these data the Agency has determined
that the established tolerance of 0.2 ppm
for ‘‘vegetable, root and tuber, group 1,
except sugar beet’’ is sufficient to cover
all measured and anticipated residues of
glyphosate in raw tubers and in potato
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peels, chips, flakes or granules.
Therefore, tolerances for potato chips,
granules, flakes and processed potato
waste are no longer needed.
In an effort to achieve compatibility
with Codex Maximum Residue Levels
(MRLs), EPA is proposing to decrease
the tolerance in 40 CFR 180.364 (a) for
residues of glyphosate
-(phosphonomethyl)glycine resulting
from the application of glyphosate, the
isopropylamine salt of glyphosate, the
ethanolamine salt of glyphosate, the
ammonium salt of glyphosate, and the
potassium salt of glyphosate in or on
kiwifruit from 0.2 ppm to 0.1 ppm.
In an effort to achieve compatibility
with Codex MRLs, EPA is proposing to
increase the tolerances in 40 CFR
180.364 (a) for residues of glyphosate
-(phosphonomethyl)glycine resulting
from the application of glyphosate, the
isopropylamine salt of glyphosate, the
ethanolamine salt of glyphosate, the
ammonium salt of glyphosate, and the
potassium salt of glyphosate in or on
cattle, liver and hog, liver from 0.5 ppm
to 1.0 ppm. The Agency has 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.
EPA is proposing to revise 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; 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, legume, group 6
except soybean to vegetable, legume,
group 6, 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 tolerance reassessment in the
RED proposed 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)
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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 proposing to remove
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.
The RED recommended that a crop
group tolerance for, ‘‘grass forage,
fodder and hay, group 17’’ be
established at 200 ppm. Since then, the
tolerance ‘‘grass forage, fodder and hay,
group 17’’ was established and
increased to 300 ppm on September 27,
2002 due to changes in the use patterns
and pre-grazing intervals (67 FR 60934,
FRL–7200–2), and (65 FR 57957, FRL–
6746–6).
Since the 1993 RED tolerance
recommendations, multiple tolerance
actions have occurred to affect those
original recommendations. The
tolerance levels and commodity names
have changed due to commodity
terminology updates, crop group
composition changes, adjustments in
use patterns or intervals of use,
additional data submissions, and
changes in the tolerance expression in
40 CFR 180.364 for glyphosate (60 FR
45062, FRL–4962–1), (61 FR 7729, FRL–
5351–5), (61 FR 15192, FRL–5351–1),
(62 FR 17723, FRL–5598–6), (63 FR
54058, FRL–6036–1), (64 FR 18360,
FRL–6073–5), (64 FR 41818, FRL–6096–
2), (64 FR 66108, FRL–6390–5), (65 FR
57957, FRL–6746–6), (67 FR 60934,
FRL–7200–2), (68 FR 36472, FRL–7308–
8), (68 FR 39460, FRL–7316–5, (69 FR
65081, FRL–7683–9), and (70 FR 7861,
FRL–7697–7).
3. Difenzoquat. Based on available
field trial data that indicate residues of
difenzoquat in or on barley grain were
non-detectable (<0.05 ppm), barley
straw were as high as 4.0 ppm, and
wheat straw were as high as 4.2 ppm,
the Agency determined that these
tolerances should be decreased to 0.05
ppm, 5.0 ppm, and 5.0 ppm,
respectively. Therefore, EPA is
proposing to decrease 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
to 5.0 ppm; and wheat, straw from 20
to 5.0 ppm.
Processing data for wheat grain and
aspirated grain fractions indicate that
residues of difenzoquat concentrated 4fold in wheat bran and 4.6-fold in
shorts, and minimal concentration
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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 proposing to establish 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 proposing to establish a
tolerance in 40 CFR 180.369 for residues
of difenzoquat in or on barley, bran at
0.25 ppm.
4. Hexazinone. 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, and in plant commodities for
regional tolerances in 40 CFR
180.396(c), should be modified to
include all the specific metabolites in
plants, animal tissue and milk.
Consequently, EPA is proposing to
separate and recodify plant, animal, and
milk tolerances from 180.396(a) to (a)(1),
(a)(2), and (a)(3), respectively.
Therefore, EPA is proposing that the
tolerance expressions in 40 CFR 180.396
read as follows:
(a)(1) General. Tolerances are established
for the combined residues of hexazinone (3cyclohexyl-6-(dimethylamino)-1-methyl1,3,5-triazine-2,4-(1H,3H)-dione and its plant
metabolites; A [3-(4-hydroxycyclohexyl)-6(dimethylamino)-1-methyl-1,3,5-triazine2,4(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-methyl1,3,5-triazine-2,4,6-(1H,3H,5H)-trione], and E
[3-(4-hydroxycyclohexyl)-1-methyl-1,3,5triazine-2,4,6-(1H,3H,5H)-trione] (calculated
as hexazinone) in the following food
commodities:
(a)(2) Tolerances are established for the
combined residues of hexazinone (3cyclohexyl-6-(dimethylamino)-1-methyl1,3,5-triazine-2,4-(1H,3H)-dione and its
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animal tissue metabolites; B [3-cyclohexyl-6(methylamino)-1-methyl-1,3,5-triazine-2,4(1H,3H)-dione] and F [3-cyclohexyl-6-amino1-methyl-1,3,5-triazine-2,4-(1H,3H)-dione
(calculated as hexazinone) in the following
food commodities:
(a)(3) Tolerances are established for the
combined residues of hexazinone (3cyclohexyl-6-(dimethylamino)-1-methyl1,3,5-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-1 [3-(2hydroxycyclohexyl)-6-(methylamino)-1methyl-1,3,5-triazine-2,4(1H,3H)-dione], C-2
[3-(3-hydroxycyclohexyl)-6-(methylamino)-1methyl-1,3,5-triazine-2,4(1H,3H)-dione] and
F (calculated as hexazinone) in milk: and
(c) Tolerances with regional registrations.
Tolerances with regional registration, as
defined in §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)-1methyl-1,3,5-triazine-2,4(1H,3H)-dione], B [3cyclohexyl-6-(methylamino)-1-methyl-1,3,5triazine-2,4-(1H,3H)-dione], C [3-(4hydroxycyclohexyl)-6-(methylamino)-1methyl-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-(4hydroxycyclohexyl)-1-methyl-1,3,5-triazine2,4,6-(1H,3H,5H)-trione] (calculated as
hexazinone) in the following commodities.
Based on available ruminant feeding
data at exaggerated pesticide dose levels
and the maximum theoretical dietary
burden, EPA determined that there is no
reasonable expectation of finite
hexazinone residues of concern in
livestock from treated feed. At an
exaggerated (62.5x) feeding level,
residues of hexazinone and its
metabolites were non-detectable; i.e.,
were below the combined limit of
quantitation (LOQs) of 0.1 ppm in fat.
Therefore, the Agency determined that
tolerances for fat of cattle, goats, hogs,
horses, and sheep are no longer needed
under 40 CFR 180.6(a)(3). As a result,
EPA is proposing to revoke the
tolerances in 40 CFR 180.396 for
combined hexazinone residues of
concern in or on cattle, fat; goat, fat;
hog, fat; horse, fat; and sheep, fat.
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.
After correction of the exaggerated
feeding dose (640x) for hogs, the Agency
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determined that residue levels of
hexazinone and its metabolites were
non-detectable; i.e., were below the
combined LOQs of 0.1 ppm in tissue.
Therefore, the tolerances on hog meat
and meat byproducts are no longer
needed under 40 CFR 180.6(a)(3). As a
result of the available ruminant feeding
data and the enforcement method, EPA
is proposing to revoke the tolerances in
40 CFR 180.396 for combined
hexazinone residues of concern in or on
hog, meat and hog, meat byproducts.
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 proposing to
increase 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 proposing to increase 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
revise 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.
Available data indicate combined
residues of hexazinone and its regulated
metabolites were <0.35 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
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raw agricultural commodity (sugarcane,
cane), it was below the current tolerance
level for sugarcane molasses and should
be decreased to 4.0 ppm. Therefore, EPA
is proposing to increase the tolerance for
sugarcane, cane and decrease the
tolerance for sugarcane, molasses with
regional registration in 40 CFR
180.396(c), as defined in 180.1(n) and
which excludes use of hexazinone on
sugarcane in Florida, for combined
hexazinone residues of concern in or on
sugarcane, cane from 0.2 to 0.6 ppm and
sugarcane molasses from 5.0 to 4.0 ppm,
and revise 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.
Based on the available residue data,
the TRED recommended decreasing the
tolerance in/on alfalfa hay contingent
upon previously requested label
revisions by the registrant related to the
pre-harvest and pre-grazing intervals.
The tolerance decrease is solely a
reflection of changes in the use pattern;
the decrease is not required for the
tolerance to be safe. The Agency is in
the process of following up with the
registrant and will address the tolerance
modification in a future Federal
Register notice.
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 proposing to establish 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 proposing to
revise commodity terminology to
conform to current Agency practice as
follows: In 40 CFR 180.396(a) alfalfa
green forage to alfalfa, forage; grass,
range to grass, forage; and grass, pasture
to grass, hay.
B. What is the Agency’s Authority for
Taking this Action?
A ‘‘tolerance’’ represents the
maximum level for residues of pesticide
chemicals legally allowed in or on raw
agricultural commodities and processed
foods. Section 408 of FFDCA, 21 U.S.C.
346a, as amended by the FQPA of 1996,
Public Law 104–170, authorizes the
establishment of tolerances, exemptions
from tolerance requirements,
modifications in tolerances, and
revocation of tolerances for residues of
pesticide chemicals in or on raw
agricultural commodities and processed
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foods. Without a tolerance or
exemption, food containing pesticide
residues is considered to be unsafe and
therefore, ‘‘adulterated’’ under section
402(a) of the FFDCA, 21 U.S.C. 342(a).
Such food may not be distributed in
interstate commerce (21 U.S.C. 331(a)).
For a food-use pesticide to be sold and
distributed, the pesticide must not only
have appropriate tolerances under the
FFDCA, but also must be registered
under FIFRA (7 U.S.C. 136 et seq.).
Food-use pesticides not registered in the
United States must have tolerances in
order for commodities treated with
those pesticides to be imported into the
United States.
EPA is proposing these tolerance
actions 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 FQPA.
The safety finding determination is
discussed 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 TREDs for pchlorophenoxyacetic 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 requirements for
additional data on the active ingredients
to confirm the potential human health
and environmental risk assessments
associated with current product uses,
and in 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
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recommended in REDs and TREDs that
are proposed in this document do not
need such assessment when the
tolerances are no longer necessary.
EPA’s general practice is to propose
revocation of tolerances for residues of
pesticide active ingredients on crops for
which FIFRA registrations no longer
exist and on which the pesticide may
therefore no longer be used in the
United States. EPA has historically been
concerned that retention of tolerances
that are not necessary to cover residues
in or on legally treated foods may
encourage misuse of pesticides within
the United States. Nonetheless, EPA
will establish and maintain tolerances
even when corresponding domestic uses
are canceled if the tolerances, which
EPA refers to as ‘‘import tolerances,’’ are
necessary to allow importation into the
United States of food containing such
pesticide residues. However, where
there are no imported commodities that
require these import tolerances, the
Agency believes it is appropriate to
revoke tolerances for unregistered
pesticides in order to prevent potential
misuse.
Furthermore, as a general matter, the
Agency believes that retention of import
tolerances not needed to cover any
imported food may result in
unnecessary restriction on trade of
pesticides and foods. Under section 408
of the FFDCA, a tolerance may only be
established or maintained if EPA
determines that the tolerance is safe
based on a number of factors, including
an assessment of the aggregate exposure
to the pesticide and an assessment of
the cumulative effects of such pesticide
and other substances that have a
common mechanism of toxicity. In
doing so, EPA must consider potential
contributions to such exposure from all
tolerances. If the cumulative risk is such
that the tolerances in aggregate are not
safe, then every one of these tolerances
is potentially vulnerable to revocation.
Furthermore, if unneeded tolerances are
included in the aggregate and
cumulative risk assessments, the
estimated exposure to the pesticide
would be inflated. Consequently, it may
be more difficult for others to obtain
needed tolerances or to register needed
new uses. To avoid potential trade
restrictions, the Agency is proposing to
revoke tolerances for residues on crops
uses for which FIFRA registrations no
longer exist, unless someone expresses
a need for such tolerances. Through this
proposed rule, the Agency is inviting
individuals who need these import
tolerances to identify themselves and
the tolerances that are needed to cover
imported commodities.
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Parties interested in retention of the
tolerances should be aware that
additional data may be needed to
support retention. These parties should
be aware that, under FFDCA section
408(f), if the Agency determines that
additional information is reasonably
required to support the continuation of
a tolerance, EPA may require that
parties interested in maintaining the
tolerances provide the necessary
information. If the requisite information
is not submitted, EPA may issue an
order revoking the tolerance at issue.
When EPA establishes tolerances for
pesticide residues in or on raw
agricultural commodities, consideration
must be given to the possible residues
of those chemicals 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). When considering this
possibility, EPA can conclude that:
1. Finite residues will exist in meat,
milk, poultry, and/or eggs.
2. There is a reasonable expectation
that finite residues will exist.
3. There is a reasonable expectation
that finite residues will not exist. If
there is no reasonable expectation of
finite pesticide residues in or on meat,
milk, poultry, or eggs, tolerances do not
need to be established for these
commodities (40 CFR 180.6(b) and (c)).
EPA has evaluated certain specific
meat, milk, poultry, and egg tolerances
proposed for revocation in this rule and
has concluded that there is no
reasonable expectation of finite
pesticide residues of concern in or on
those commodities.
C. When do These Actions Become
Effective?
EPA is proposing that these
revocations, modifications,
establishments of tolerances, and
commodity terminology revisions
become effective on the date of
publication of the final rule in the
Federal Register. For this rule, proposed
revocations will affect tolerances for
uses which have been canceled for
many years or are no longer needed. The
Agency believes that treated
commodities have had sufficient time
for passage through the channels of
trade. However, if EPA is presented
with information that existing stocks
would still be available and that
information is verified, the Agency will
consider extending the expiration date
of the tolerance. If you have comments
regarding existing stocks and whether
the effective date allows sufficient time
for treated commodities to clear the
channels of trade, please submit
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comments as described under
SUPPLEMENTARY INFORMATION.
Any commodities listed in this
proposal treated with the pesticides
subject to this proposal, and in the
channels of trade following the
tolerance revocations, shall be subject to
FFDCA section 408(1)(5), as established
by FQPA. Under this section, any
residues of these pesticides in or on
such food shall not render the food
adulterated so long as it is shown to the
satisfaction of the Food and Drug
Administration that: (1) The residue is
present as the result of an application or
use of the pesticide at a time and in a
manner that was lawful under FIFRA,
and (2) the residue does not exceed the
level that was authorized at the time of
the application or use to be present on
the food under a tolerance or exemption
from tolerance. Evidence to show that
food was lawfully treated may include
records that verify the dates when the
pesticide was applied to such food.
D. What Is the Contribution to Tolerance
Reassessment?
By law, EPA is required by August 3,
2006 to reassess the tolerances in
existence on August 2, 1996. As of April
19, 2006, EPA has reassessed over 8,070
tolerances. Regarding tolerances
mentioned in this proposed rule,
tolerances in existence as of August 2,
1996 were previously counted as
reassessed at the time of the signature
completion of a post-FQPA RED or
TRED for each active ingredient.
Therefore, no further tolerance
reassessments would be counted toward
the August 2006 review deadline.
III. Are The Proposed Actions
Consistent with International
Obligations?
The tolerance revocations in this
proposal are not discriminatory and are
designed to ensure that both
domestically-produced and imported
foods meet the food safety standard
established by the FFDCA. The same
food safety standards apply to
domestically produced and imported
foods.
EPA is working to ensure that the U.S.
tolerance reassessment program under
FQPA does not disrupt international
trade. EPA considers Codex MRLs in
setting U.S. tolerances and in
reassessing them. MRLs are established
by the Codex Committee on Pesticide
Residues, a committee within the Codex
Alimentarius Commission, an
international organization formed to
promote the coordination of
international food standards. It is EPA’s
policy to harmonize U.S. tolerances
with Codex MRLs to the extent possible,
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provided that the MRLs achieve the
level of protection required under
FFDCA. EPA’s effort to harmonize with
Codex MRLs is summarized in the
tolerance reassessment section of
individual Reregistration Eligibility
Decision documents. EPA has
developed guidance concerning
submissions for import tolerance
support in the Federal Register of June
1, 2000 (65 FR 35069) (FRL–6559–3).
This guidance will be made available to
interested persons. Electronic copies are
available on the internet at https://
www.epa.gov/. On the Home Page select
‘‘Laws, Regulations, and Dockets,’’ then
select ‘‘Regulations and Proposed
Rules’’ and then look up the entry for
this document under ‘‘Federal
Register’’—Environmental Documents.’’
You can also go directly to the ‘‘Federal
Register’’ listings at https://
www.epa.gov/fedrgstr/.
IV. Statutory and Executive Order
Reviews
In this proposed rule, EPA is
proposing to establish tolerances under
FFDCA section 408(e), and also modify
and revoke 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 proposed
rule has been exempted from review
under Executive Order 12866 due to its
lack of significance, this proposed rule
is not subject to Executive Order 13211,
Actions Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001). This proposed rule does not
contain any information collections
subject to OMB approval under the
Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., or impose any
enforceable duty or contain any
unfunded mandate as described under
Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public
Law 104–4). Nor does it require any
special considerations as required by
Executive Order 12898, entitled Federal
Actions to Address Environmental
Justice in Minority Populations and
Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or
any other Agency action under
Executive Order 13045, entitled
Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
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This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note). Pursuant to
the Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.), the Agency
previously assessed whether
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
proposed rule, the Agency hereby
certifies that this proposed action will
not have a significant negative 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
this proposed rule). Furthermore, for the
pesticide named in this proposed rule,
the Agency knows of no extraordinary
circumstances that exist as to the
present proposal that would change the
EPA’s previous analysis. Any comments
about the Agency’s determination
should be submitted to the EPA along
with comments on the proposal, and
will be addressed prior to issuing a final
rule. In addition, the Agency has
determined that this action will not
have a substantial direct effect on States,
on the relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government, as specified in
Executive Order 13132,entitled
Federalism (64 FR 43255, August 10,
1999). Executive Order 13132 requires
EPA to develop an accountable process
to ensure ‘‘meaningful and timely input
by State and local officials in the
development of regulatory policies that
have federalism implications.’’ ‘‘Policies
that have federalism implications’’ is
defined in the Executive order to
include regulations that have
‘‘substantial direct effects on the States,
on the relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government.’’ This proposed
rule directly regulates growers, food
processors, food handlers and food
retailers, not States. This action does not
alter the relationships or distribution of
power and responsibilities established
by Congress in the preemption
provisions of section 408(n)(4) of the
FFDCA. For these same reasons, the
Agency has determined that this
proposed rule does not have any ‘‘tribal
implications’’ as described in Executive
Order 13175, entitled Consultation and
Coordination with Indian Tribal
Governments (65 FR 67249, November
6, 2000). Executive Order 13175,
requires EPA to develop an accountable
process to ensure ‘‘meaningful and
timely input by tribal officials in the
development of regulatory policies that
have tribal implications.’’ ‘‘Policies that
have tribal implications’’ is defined in
the Executive order to include
regulations that have ‘‘substantial direct
effects on one or more Indian tribes, on
the relationship between the Federal
Government and the Indian tribes, or on
the distribution of power and
responsibilities between the Federal
Government and Indian tribes.’’ This
proposed rule will not have substantial
direct effects on tribal governments, on
the relationship between the Federal
Government and Indian tribes, or on the
distribution of power and
responsibilities between the Federal
Government and Indian tribes, as
specified in Executive Order 13175.
Thus, Executive Order 13175 does not
apply to this proposed rule.
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: May 30, 2006.
James Jones,
Director, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR
chapter I be amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In §180.202, paragraph (a) is
revised to read as follows:
§ 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:
Bean, mung, sprouts ................
*
*
*
*
3. In §180.364, the table in paragraph
(a) is revised to read as follows:
§ 180.364 Glyphosate; tolerances for
residues.
(a) General. * * *
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Parts per million
Acerola .................................................................................................................................................................................
Alfalfa, seed .........................................................................................................................................................................
Almond, hulls .......................................................................................................................................................................
Animal feed, nongrass, group 18 ........................................................................................................................................
Aloe vera ..............................................................................................................................................................................
Ambarella .............................................................................................................................................................................
Artichoke, globe ...................................................................................................................................................................
Asparagus ............................................................................................................................................................................
Atemoya ...............................................................................................................................................................................
Avocado ...............................................................................................................................................................................
Bamboo, shoots ...................................................................................................................................................................
Banana .................................................................................................................................................................................
Barley, bran .........................................................................................................................................................................
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*
Commodity
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million
Commodity
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0.5
25
400
0.5
0.2
0.2
0.5
0.2
0.2
0.2
0.2
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Commodity
Parts per million
Barley, grain .........................................................................................................................................................................
Beet, sugar, dried pulp ........................................................................................................................................................
Beet, sugar, roots ................................................................................................................................................................
Beet, sugar, tops .................................................................................................................................................................
Berry group 13 .....................................................................................................................................................................
Betelnut ................................................................................................................................................................................
Biriba ....................................................................................................................................................................................
Blimbe ..................................................................................................................................................................................
Borage, seed .......................................................................................................................................................................
Breadfruit .............................................................................................................................................................................
Cactus, fruit ..........................................................................................................................................................................
Cactus, pads ........................................................................................................................................................................
Canistel ................................................................................................................................................................................
Canola, meal ........................................................................................................................................................................
Canola, seed ........................................................................................................................................................................
Cattle, kidney .......................................................................................................................................................................
Cattle, liver ...........................................................................................................................................................................
Chaya ...................................................................................................................................................................................
Cherimoya ............................................................................................................................................................................
Citrus, dried pulp .................................................................................................................................................................
Cacao bean .........................................................................................................................................................................
Coconut ................................................................................................................................................................................
Coffee, bean ........................................................................................................................................................................
Corn, field, forage ................................................................................................................................................................
Corn, field, grain ..................................................................................................................................................................
Cotton, gin byproducts .........................................................................................................................................................
Cotton, undelinted seed .......................................................................................................................................................
Cranberry .............................................................................................................................................................................
Crambe, seed ......................................................................................................................................................................
Custard apple ......................................................................................................................................................................
Date .....................................................................................................................................................................................
Dokudami .............................................................................................................................................................................
Durian ..................................................................................................................................................................................
Egg .......................................................................................................................................................................................
Epazote ................................................................................................................................................................................
Feijoa ...................................................................................................................................................................................
Fig ........................................................................................................................................................................................
Fish ......................................................................................................................................................................................
Flax, meal ............................................................................................................................................................................
Flax, seed ............................................................................................................................................................................
Fruit, citrus, group 10 ..........................................................................................................................................................
Fruit, pome, group 11 ..........................................................................................................................................................
Fruit, stone, group 12 ..........................................................................................................................................................
Galangal, root ......................................................................................................................................................................
Ginger, white, flower ............................................................................................................................................................
Goat, kidney .........................................................................................................................................................................
Goat, liver ............................................................................................................................................................................
Gourd, buffalo, seed ............................................................................................................................................................
Governor’s plum ..................................................................................................................................................................
Gow kee, leaves ..................................................................................................................................................................
Grain, aspirated fractions ....................................................................................................................................................
Grain, cereal, forage, fodder and straw, group 16 ..............................................................................................................
Grain, cereal, group 15, except barley, field corn, grain sorghum, oat and wheat ............................................................
Grape ...................................................................................................................................................................................
Grass, forage, fodder and hay, group 17 ............................................................................................................................
Guava ..................................................................................................................................................................................
Herbs subgroup 19A ............................................................................................................................................................
Hog, kidney ..........................................................................................................................................................................
Hog, liver ..............................................................................................................................................................................
Hop, dried cones .................................................................................................................................................................
Horse, kidney .......................................................................................................................................................................
Horse, liver ...........................................................................................................................................................................
Ilama ....................................................................................................................................................................................
Imbe .....................................................................................................................................................................................
Imbu .....................................................................................................................................................................................
Jaboticaba ............................................................................................................................................................................
Jackfruit ................................................................................................................................................................................
Jojoba, seed ........................................................................................................................................................................
Juneberry .............................................................................................................................................................................
Kava, roots ...........................................................................................................................................................................
Kenaf, forage .......................................................................................................................................................................
Kiwifruit ................................................................................................................................................................................
Lesquerella, seed ................................................................................................................................................................
Leucaena, forage .................................................................................................................................................................
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25
10
10
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0.2
0.2
0.1
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0.5
0.2
15
10
4.0
1.0
1.0
0.2
1.5
0.2
0.1
1.0
6.0
1.0
175
35
0.2
0.1
0.2
0.2
2.0
0.2
0.05
1.3
0.2
0.2
0.25
8.0
4.0
0.5
0.2
0.2
0.2
0.2
4.0
0.5
0.1
0.2
0.2
100.0
100
0.1
0.2
300
0.2
0.2
4.0
1.0
7.0
4.0
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0.2
0.2
0.2
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0.1
0.2
0.2
200
0.1
0.1
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Federal Register / Vol. 71, No. 109 / Wednesday, June 7, 2006 / Proposed Rules
rwilkins on PROD1PC63 with PROPOSAL
Commodity
Parts per million
Lingonberry ..........................................................................................................................................................................
Longan .................................................................................................................................................................................
Lychee .................................................................................................................................................................................
Mamey apple .......................................................................................................................................................................
Mango ..................................................................................................................................................................................
Mangosteen .........................................................................................................................................................................
Marmaladebox .....................................................................................................................................................................
Meadowfoam, seed .............................................................................................................................................................
Mioga, flower .......................................................................................................................................................................
Mustard, seed ......................................................................................................................................................................
Nut, pine ..............................................................................................................................................................................
Nut, tree, group 14 ..............................................................................................................................................................
Oat, grain .............................................................................................................................................................................
Okra .....................................................................................................................................................................................
Olive .....................................................................................................................................................................................
Oregano, Mexican, leaves ...................................................................................................................................................
Palm heart ...........................................................................................................................................................................
Palm heart, leaves ...............................................................................................................................................................
Palm, oil ...............................................................................................................................................................................
Papaya .................................................................................................................................................................................
Papaya, mountain ................................................................................................................................................................
Passionfruit ..........................................................................................................................................................................
Pawpaw ...............................................................................................................................................................................
Peanut ..................................................................................................................................................................................
Peanut, forage .....................................................................................................................................................................
Peanut, hay ..........................................................................................................................................................................
Pepper leaf, fresh leaves .....................................................................................................................................................
Peppermint, tops ..................................................................................................................................................................
Perilla, tops ..........................................................................................................................................................................
Persimmon ...........................................................................................................................................................................
Pineapple .............................................................................................................................................................................
Pistachio ..............................................................................................................................................................................
Pomegranate .......................................................................................................................................................................
Poultry, meat ........................................................................................................................................................................
Poultry, meat byproducts .....................................................................................................................................................
Pulasan ................................................................................................................................................................................
Quinoa, grain .......................................................................................................................................................................
Rambutan ............................................................................................................................................................................
Rapeseed, meal ...................................................................................................................................................................
Rapeseed, seed ...................................................................................................................................................................
Rose apple ...........................................................................................................................................................................
Safflower, seed ....................................................................................................................................................................
Salal .....................................................................................................................................................................................
Sapodilla ..............................................................................................................................................................................
Sapote, black .......................................................................................................................................................................
Sapote, mamey ....................................................................................................................................................................
Sapote, white .......................................................................................................................................................................
Sesame, seed ......................................................................................................................................................................
Sheep, kidney ......................................................................................................................................................................
Sheep, liver ..........................................................................................................................................................................
Shellfish ...............................................................................................................................................................................
Sorghum, grain, grain ..........................................................................................................................................................
Soursop ................................................................................................................................................................................
Soybean, seed .....................................................................................................................................................................
Soybean, forage ..................................................................................................................................................................
Soybean, hay .......................................................................................................................................................................
Soybean, hulls .....................................................................................................................................................................
Spanish lime ........................................................................................................................................................................
Spearmint, tops ....................................................................................................................................................................
Spice subgroup 19B ............................................................................................................................................................
Star apple ............................................................................................................................................................................
Starfruit ................................................................................................................................................................................
Stevia, dried leaves .............................................................................................................................................................
Strawberry ............................................................................................................................................................................
Sugar apple .........................................................................................................................................................................
Sugarcane, cane ..................................................................................................................................................................
Sugarcane, molasses ..........................................................................................................................................................
Sunflower, seed ...................................................................................................................................................................
Surinam cherry ....................................................................................................................................................................
Tamarind ..............................................................................................................................................................................
Tea, dried .............................................................................................................................................................................
Tea, instant ..........................................................................................................................................................................
Teff, grain .............................................................................................................................................................................
Ti, leaves .............................................................................................................................................................................
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2.0
0.2
0.2
0.1
0.2
0.2
0.2
0.2
0.1
0.5
0.5
0.2
200
1.8
0.2
0.1
1.0
0.2
0.1
1.0
0.2
5.0
0.2
15
10
0.2
0.1
0.2
0.2
0.2
0.2
0.2
0.1
4.0
0.5
3.0
15
0.2
20
100
200
100
0.2
200
7.0
0.2
0.2
1.0
0.2
0.2
2.0
30
0.1
0.2
0.2
1.0
7.0
5.0
0.2
32908
Federal Register / Vol. 71, No. 109 / Wednesday, June 7, 2006 / Proposed Rules
Commodity
Parts per million
Ti, roots ................................................................................................................................................................................
Ugli fruit ................................................................................................................................................................................
Vegetable, brassica, leafy, group 5 .....................................................................................................................................
Vegetable, bulb, group 3 .....................................................................................................................................................
Vegetable, cucurbit, group 9 ...............................................................................................................................................
Vegetable, foliage of legume, subgroup 7A, except soybean ............................................................................................
Vegetable, fruiting, group 8 .................................................................................................................................................
Vegetable, leafy, group 4 ....................................................................................................................................................
Vegetable, leaves of root and tuber, group 2, except sugar beet tops ..............................................................................
Vegetable, legume, group 6, except soybean .....................................................................................................................
Vegetable, root and tuber, group 1, except sugar beet ......................................................................................................
Wasabi, roots .......................................................................................................................................................................
Water spinach, tops .............................................................................................................................................................
Watercress, upland ..............................................................................................................................................................
Wax jambu ...........................................................................................................................................................................
Wheat, bran .........................................................................................................................................................................
Wheat, grain ........................................................................................................................................................................
Wheat, middlings .................................................................................................................................................................
Wheat, shorts .......................................................................................................................................................................
Yacon, tuber ........................................................................................................................................................................
*
*
*
*
*
4. Section 180.369 is amended by
designating the current text as
paragraph (a) and adding the heading;
by revising the table; and by adding and
reserving paragraphs (b), (c), and (d)
with headings to read as follows:
§ 180.369 Difenzoquat; tolerances for
residues.
(a) General * * *
Commodity
Parts per
million
rwilkins on PROD1PC63 with PROPOSAL
Barley, bran ..............................
Barley, grain .............................
Barley, straw .............................
Cattle, fat ..................................
Cattle, meat ..............................
Cattle, meat byproducts ...........
Goat, fat ....................................
Goat, meat ................................
Goat, meat byproducts .............
Hog, fat .....................................
Hog, meat .................................
Hog, meat byproducts ..............
Horse, fat ..................................
Horse, meat ..............................
Horse, meat byproducts ...........
Poultry, fat ................................
Poultry, meat ............................
Poultry, meat byproducts ..........
Sheep, fat .................................
Sheep, meat .............................
Sheep, meat byproducts ..........
Wheat, bran ..............................
Wheat, grain .............................
Wheat, shorts ...........................
Wheat, straw .............................
0.25
0.05
5.0
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.25
0.05
0.25
5.0
(b) Section emergency exemptions.
[Resereved]
(c) Tolerances with regional
registrations. [Reserved]
(d) Indirect or inavertant residues.
[Reserved]
5. In §180.396, paragraphs (a) and (c)
are revised to read as follows:
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§ 180.396 Hexazinone; tolerances for
residues.
Commodity
(a) General. (1) Tolerances are
established for the combined residues of
hexazinone (3-cyclohexyl-6(dimethylamino)-1-methyl-1,3,5triazine-2,4-(1H,3H)-dione and its plant
metabolites; A [3-(4hydroxycyclohexyl)-6-(dimethylamino)1-methyl-1,3,5-triazine-2,4(1H,3H)dione], B [3-cyclohexyl-6(methylamino)-1-methyl-1,3,5-triazine2,4-(1H,3H)-dione], C [3-(4hydroxycyclohexyl)-6-(methylamino)-1methyl-1,3,5-triazine-2,4-(1H,3H)dione], D [3-cyclohexyl)-1-methyl-1,3,5triazine-2,4,6-(1H,3H,5H)-trione], and E
[3-(4-hydroxycyclohexyl)-1-methyl1,3,5-triazine-2,4,6-(1H,3H,5H)-trione]
(calculated as hexazinone) in the
following commodities:
Commodity
Alfalfa, forage ...........................
Alfalfa, hay ................................
Alfalfa, seed ..............................
Blueberry ..................................
Grass, hay ................................
Grass, forage ............................
Pineapple ..................................
Cattle, meat ..............................
Cattle, meat byproducts ...........
Goat, meat ................................
Goat, meat byproducts .............
Horse, meat ..............................
Horse, meat byproduct .............
Sheep, meat .............................
Sheep, meat byproducts ..........
2.0
0.6
10.0
10.0
0.6
Commodity
Milk ...........................................
*
Frm 00036
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Parts per
million
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
(3) Tolerances are established for the
combined residues of hexazinone (3cyclohexyl-6-(dimethylamino)-1methyl-1,3,5-triazine-2,4-(1H,3H)-dione
and its metabolites; B [3-cyclohexyl-6(methylamino)-1-methyl-1,3,5-triazine2,4-(1H,3H)-dione], C [3-(4hydroxycyclohexyl)-6-(methylamino)-1methyl-1,3,5-triazine-2,4-(1H,3H)dione], C-1 [3-(2-hydroxycyclohexyl)-6(methylamino)-1-methyl-1,3,5-triazine2,4(1H,3H)-dione], C-2 [3-(3hydroxycyclohexyl)-6-(methylamino)-1Parts per
methyl-1,3,5-triazine-2,4(1H,3H)-dione]
million
and F [3-cyclohexyl-6-amino-1-methyl2.0 1,3,5-triazine-2,4-(1H,3H)-dione]
8.0 (calculated as hexazinone) in milk:
(2) Tolerances are established for the
combined residues of hexazinone (3cyclohexyl-6-(dimethylamino)-1methyl-1,3,5-triazine-2,4-(1H,3H)-dione
and its animal tissue metabolites; B [3cyclohexyl-6-(methylamino)-1-methyl1,3,5-triazine-2,4-(1H,3H)-dione], and F
[3-cyclohexyl-6-amino-1-methyl-1,3,5triazine-2,4-(1H,3H)-dione] (calculated
as hexazinone) in the following food
commodities:
PO 00000
0.2
0.5
0.2
0.2
0.5
0.2
0.1
0.2
0.2
5.0
0.2
0.2
0.2
0.2
0.2
20
5.0
20
20
0.2
Parts per
million
0.2
*
*
*
*
(c) Tolerances with regional
registrations. Tolerances with regional
registration, as defined in §180.1(n) and
which excludes use of hexazinone on
sugarcane in Florida, are established for
the combined residues of hexazinone (3cyclohexyl-6-(dimethylamino)-1methyl-1,3,5-triazine-2,4-(1H,3H)-dione
and its plant metabolites; A [3-(4hydroxycyclohexyl)-6-(dimethylamino)1-methyl-1,3,5-triazine-2,4(1H,3H)dione], B [3-cyclohexyl-6-
E:\FR\FM\07JNP1.SGM
07JNP1
32909
Federal Register / Vol. 71, No. 109 / Wednesday, June 7, 2006 / Proposed Rules
Information Center (Room CY–A257),
445 12th Street, SW., Washington, DC
This document may also be purchased
from the Commission’s duplicating
contractors, Best Copy and Printing,
Inc., 445 12th Street, SW, Room CY–
B402, Washington, DC 20554, telephone
1–800–378–3160 or https://
www.BCPIWEB.com.
This document is not subject to the
Congressional Review Act. (The
Parts per
Commission, is, therefore, not required
Commodity
million
to submit a copy of this Report and
Order to Government Accountability
Sugarcane, cane ......................
0.6
Sugarcane, molasses ...............
4.0 Office, pursuant to the Congressional
Review Act, see 5 U.S.C. Section
801(a)(1)(A) since this proposed rule is
*
*
*
*
*
dismissed, herein.)
[FR Doc. E6–8827 Filed 6–6–06; 8:45 am]
(methylamino)-1-methyl-1,3,5-triazine2,4-(1H,3H)-dione], C [3-(4hydroxycyclohexyl)-6-(methylamino)-1methyl-1,3,5-triazine-2,4-(1H,3H)dione], D [3-cyclohexyl)-1-methyl-1,3,5triazine-2,4,6-(1H,3H,5H)-trione], and E
[3-(4-hydroxycyclohexyl)-1-methyl1,3,5-triazine-2,4,6-(1H,3H,5H)-trione]
(calculated as hexazinone) in the
following commodities:
Federal Communications Commission.
John A. Karousos,
Assistant Chief, Audio Division, Media
Bureau.
[FR Doc. E6–8732 Filed 6–6–06; 8:45 am]
BILLING CODE 6560–50–S
FEDERAL COMMUNICATIONS
COMMISSION
BILLING CODE 6712–01–P
I. Background
47 CFR Part 73
[DA 06–1052; MB Docket No. 05–145, RM–
11212]
DEPARTMENT OF TRANSPORTATION
Radio Broadcasting Services;
Hermitage and Mercer, PA
Pipeline and Hazardous Materials
Safety Administration
Federal Communications
Commission.
ACTION: Proposed rule, dismissal.
49 CFR Part 173
AGENCY:
[Docket No. PHMSA–99–6223 (HM–213B)]
This document dismisses a
pending petition for rule making, as
requested by Petitioner Cumulus
Licensing LLC, licensee of Station
WWIZ(FM), Mercer, Pennsylvania,
which proposed to reallot Channel 280A
from Mercer to Hermitage,
Pennsylvania, and modify the license of
WWIZ accordingly. The document
therefore terminates the proceeding.
ADDRESSES: Federal Communications
Commission, Washington, DC 20554.
FOR FURTHER INFORMATION CONTACT:
Helen McLean, Media Bureau (202)
418–2738.
SUPPLEMENTARY INFORMATION: This is a
synopsis of the Commission’s Report
and Order, MB Docket No. 05–145,
adopted May 17, 2006, and released
May 19, 2006. The full text of this
Commission decision is available for
inspection and copying during normal
business hours in the FCC Reference
SUMMARY:
benefits of proposed regulatory
approaches would not justify the
corresponding costs. Although PHMSA
is withdrawing its rulemaking proposal,
the agency will develop and implement
an outreach program to educate the
industry, first responder community,
and the public about potential risks
associated with unprotected product
pipelines on these vehicles and will
continue to collect data and other
information in order to address the issue
further if warranted.
FOR FURTHER INFORMATION CONTACT: Ben
Supko, Office of Hazardous Materials
Standards, Pipeline and Hazardous
Materials Safety Administration,
telephone (202) 366–8553; or Michael
Stevens, Office of Hazardous Materials
Standards, Pipeline and Hazardous
Materials Safety Administration,
telephone (202) 366–8553.
SUPPLEMENTARY INFORMATION:
RIN 2137–AD36
Hazardous Materials: Safety
Requirements for External Product
Piping on Cargo Tanks Transporting
Flammable Liquids
Pipeline and Hazardous
Materials Safety Administration
(PHMSA), DOT.
ACTION: Withdrawal of notice of
proposed rulemaking.
AGENCY:
SUMMARY: PHMSA is closing this
rulemaking proceeding, having
considered and declined to adopt
proposals for further regulating the
transportation of flammable liquids in
the product piping on cargo tank motor
vehicles. On the basis of public
comments and additional data and
analysis, PHMSA has concluded that
further regulation would not produce
the level of benefits we originally
expected and that the quantifiable
On December 30, 2004 the Pipeline
and Hazardous Materials Safety
Administration (PHMSA, we) published
a notice of proposed rulemaking
(NPRM) (69 FR 78375) inviting
comments on a proposal to amend the
Hazardous Materials Regulations (HMR;
49 CFR parts 171–180) to prohibit the
carriage of flammable liquids in the
product piping (wetlines) on cargo tank
motor vehicles (CTMVs), unless the
CTMV is equipped with bottom damage
protection devices. We proposed a
quantity limit of one liter or less in each
pipe. We did not propose a specific
method for achieving this standard. The
NPRM included an exception from the
proposed requirements for truckmounted (e.g., straight truck) DOT
specification CTMVs. We proposed to
make the changes effective two years
after the effective date of a final rule and
to permit CTMV operators five years to
phase in requirements applicable to
existing CTMVs.
II. Comments on the NPRM
We received thirty sets of public
comments on the NPRM from a variety
of stakeholders, including industry
associations, companies, governmental
entities, individuals and members of
Congress, as follows:
rwilkins on PROD1PC63 with PROPOSAL
Commenter
Document number
Maurice R. Tetreault ................................................................................................................................................................
American Petroleum Institute (API) .........................................................................................................................................
Georgia Department of Motor Vehicle Safety .........................................................................................................................
Southwest Research Institute ..................................................................................................................................................
David M. Lawler .......................................................................................................................................................................
Dale L. Botkin ..........................................................................................................................................................................
Public Utilities Commission of Ohio ........................................................................................................................................
RSPA–1999–6223–28
RSPA–1999–6223–32
RSPA–1999–6223–33
RSPA–1999–6223–34
RSPA–1999–6223–35
RSPA–1999–6223–37
RSPA–1999–6223–38
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Agencies
[Federal Register Volume 71, Number 109 (Wednesday, June 7, 2006)]
[Proposed Rules]
[Pages 32899-32909]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-8827]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0036; FRL-8062-7]
p-Chlorophenoxyacetic acid, Glyphosate, Difenzoquat, and
Hexazinone; Proposed Tolerance Actions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: EPA is proposing to revoke certain tolerances for the plant
growth regulator p-chlorophenoxyacetic acid and the herbicide
hexazinone. Also, EPA is proposing to modify certain tolerances for the
plant growth regulator p-chlorophenoxyacetic acid and the herbicides
glyphosate, difenzoquat, and hexazinone. In addition, EPA is proposing
to establish new tolerances for the herbicides difenzoquat and
hexazinone. The regulatory actions proposed in this document are part
of the Agency's reregistration program under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), and the tolerance reassessment
requirements of the Federal Food, Drug, and Cosmetic Act (FFDCA)
section 408(q), as amended by the Food Quality Protection Act (FQPA) of
1996. By law, EPA is required by August 2006 to reassess the tolerances
that were in existence on August 2, 1996. No tolerance reassessments
will be counted at the time of a final rule because tolerances in
existence on August 2, 1996 that are associated with actions proposed
herein were previously counted as reassessed at the time of the
completed Reregistration Eligibility Decision (RED), Report of the FQPA
Tolerance Reassessment Progress and Risk Management Decision (TRED), or
Federal Register action.
DATES: Comments must be received on or before August 7, 2006.
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 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 https://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: 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).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in Unit IIA. If you have
any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
B. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as
CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
C. What Can I do if I Wish the Agency to Maintain a Tolerance that the
Agency Proposes to Revoke?
This proposed rule provides a comment period of 60 days for any
person to state an interest in retaining a tolerance proposed for
revocation. If EPA receives a comment within the 60-day period to that
effect, EPA will not proceed to revoke the tolerance immediately.
However, EPA will take steps to ensure the submission of any needed
supporting data and will issue an order in the Federal Register under
FFDCA section 408(f) if needed. The order would specify data needed and
the time frames for its submission, and would require that within 90
days some person or persons notify EPA that they will submit the data.
If the data are not submitted as required in the order, EPA will take
appropriate action under FFDCA.
EPA issues a final rule after considering comments that are
submitted in response to this proposed
[[Page 32900]]
rule. In addition to submitting comments in response to this proposal,
you may also submit an objection at the time of the final rule. If you
fail to file an objection to the final rule within the time period
specified, you will have waived the right to raise any issues resolved
in the final rule. After the specified time, issues resolved in the
final rule cannot be raised again in any subsequent proceedings.
II. Background
A. What Action is the Agency Taking?
EPA is proposing to revoke, remove, modify, and establish 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 proposing these tolerance actions 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 FQPA. The safety finding determination of ``reasonable
certainty of no harm'' is discussed in detail in each RED and report of
the 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, 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, P.O. Box 42419,
Cincinnati, OH 45242-2419, telephone 1-00-490-9198; fax 1-513-489-8695;
internet at https://www.epa.gov/ncepihom/ and from the National
Technical Information Service, 5285 Port Royal Road, Springfield, VA
22161, telephone 1-800-553-6847 or 703-605-6000; internet at https://
www.ntis.gov/. Electronic copies of REDs and TREDs are available on the
internet for glyphosate at https://www.epa.gov/pesticides/
reregistration/status.htm, and p-chlorophenoxyacetic acid, difenzoquat,
and hexazinone in public dockets EPA-HQ-OPP-2003-0124, EPA-HQ-OPP-2002-
0097, and EPA-HQ-OPP-2002-0188, respectively, at https://
www.regulations.gov.
The selection of an individual tolerance level is based on crop
field residue studies designed to produce the maximum residues under
the existing or proposed product label. Generally, the level selected
for a tolerance is a value slightly above the maximum residue found in
such studies. The evaluation of whether a tolerance is safe is a
separate inquiry. EPA recommends the raising of a tolerance when data
show that (1) lawful use (sometimes through a label change) may result
in a higher residue level on the commodity, and (2) the tolerance
remains safe, notwithstanding increased residue level allowed under the
tolerance. In REDs, Chapter IV on ``Risk management, Reregistration,
and Tolerance Reassessment'' typically describes the regulatory
position, FQPA assessment, cumulative safety determination,
determination of safety for U.S. general population, and safety for
infants and children. In particular, the human health risk assessment
document which supports the RED describes risk exposure estimates and
whether the Agency has concerns. In TREDs, the Agency discusses its
evaluation of the dietary risk associated with the active ingredient
and whether it can determine that there is a reasonable certainty (with
appropriate mitigation) that no harm to any population subgroup will
result from aggregate exposure.
Explanations for proposed modifications in tolerances can be found
in the RED and TRED document and in more detail in the Residue
Chemistry Chapter document which supports the RED and TRED. Copies of
the Residue Chemistry Chapter documents are found in the Administrative
Record and paper copies for difenzoquat and hexazinone can be found
under their respective public docket numbers, identified above. Paper
copies for p-chlorophenoxyacetic acid and glyphosate are available in
the public docket for this rule. Electronic copies are available
through EPA's electronic public docket and comment system,
regulations.gov at https://www.regulations.gov/. You may search for this
rule under docket number EPA-HQ-OPP-2006-0036, or for an individual
chemical under its respective docket number, then click on that docket
number to view its contents.
The aggregate exposures and risks are not of concern for the above
mentioned pesticide active ingredients based upon the data identified
in the RED or TRED which lists the submitted studies that the Agency
found acceptable.
EPA has found that the tolerances that are proposed in this
document to be established or modified, are safe, i.e., that there is a
reasonable certainty that no harm will result to infants and children
from aggregate exposure to the pesticide chemical residues, in
accordance with section 408(b)(2)(C). (Note that changes to tolerance
nomenclature do not constitute modifications of tolerances). These
findings are discussed in detail in each RED or TRED. The references
are available for inspection as described in this document under
SUPPLEMENTARY INFORMATION.
In addition, EPA is proposing to revoke certain specific tolerances
because either they are no longer needed or are associated with food
uses that are no longer registered under FIFRA. Those instances where
registrations were canceled were because the registrant failed to pay
the required maintenance fee and/or the registrant voluntarily canceled
one or more registered uses of the pesticide. It is EPA's general
practice to propose revocation of those tolerances for residues of
pesticide active ingredients on crop uses for which there are no active
registrations under FIFRA, unless any person in comments on the
proposal indicates a need for the tolerance to cover residues in or on
imported commodities or domestic commodities legally treated.
1. p-Chlorophenoxyacetic acid. The Agency canceled the last
registered uses for p-chlorophenoxyacetic acid on tomato in May 1995.
Therefore, the Agency is proposing to revoke 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, remove paragraph (a)(1), and recodify existing paragraph (a)(2)
as paragraph (a).
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 proposing
to decrease 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).
2. Glyphosate. A RED was completed on glyphosate in September 1993
before the passage of the FQPA. On April 11, 1997 (62 FR 17723) (FRL-
5598-6) EPA published a notice in the Federal Register which
established new uses for glyphosate. Existing tolerances for glyphosate
in 40 CFR 180.364 were
[[Page 32901]]
considered by the Agency to be reassessed at that time. Although the
glyphosate RED recommended revocation of tolerances based on no
registered uses for the following food commodities; bread fruit,
canistel, cherimoya, cacao bean, date, marmaladebox (formerly genip),
jaboticaba, jackfruit, persimmon, sapote (black and white), soursop,
and tamarind at 0.2 ppm and coconut at 0.1 ppm; these food uses are
currently active and have existed for years since the RED. Canistel,
cacao bean, jackfruit, and sapote have existed since 2003; bread fruit,
cherimoya, marmaladebox, jaboticaba, soursop, and tamarind since 2000,
and persimmon and dates since 1998. Therefore, EPA will maintain these
tolerances in 40 CFR 180.364.
Data on glyphosate residues in or on both tea leaves and instant
tea were available at the time of the RED. Nevertheless, instant tea
was also recommended for revocation in the RED because the Agency at
that time did not consider it to be a significant item in the daily
dietary risk assessment of the population of the United States from
pesticide use on that processed commodity. However, instant tea is now
considered to be a processed commodity according to the ``Table 1.--Raw
Agricultural and Processed Commodities and Feedstuffs Derived from
Crops'' which is found in Residue Chemistry Test Guidelines OPPTS
860.1000 dated August 1996, available at https://www.epa.gov/opptsfrs/
publications/OPPTS_Harmonized/860_Residue_Chemistry_Test_
Guidelines/Series/. As stated above, existing tolerances for glyphosate
in 40 CFR 180.364, including instant tea, were reassessed at the time
of new use approvals on (April 11, 1997, 62 FR 17723). Therefore, EPA
will maintain the tolerance on ``tea, instant'' in 40 CFR 180.364.
In the RED, it was recommended that tolerances be established for
potato chips, granules, flakes and processed potato waste; however, the
quality of the data for potato chips, granules and processed potato
waste was in question. In 1996 new residue data on potatoes and
processed potato foods and feeds were provided to the Agency. These
data indicated that at the 10x rate residues were <0.01 ppm glyphosate
in or on fresh potato chips, dry peel, and wet peel; and 0.02 - 0.049
ppm glyphosate on fresh flakes. Based on these data the Agency has
determined that the established tolerance of 0.2 ppm for ``vegetable,
root and tuber, group 1, except sugar beet'' is sufficient to cover all
measured and anticipated residues of glyphosate in raw tubers and in
potato peels, chips, flakes or granules. Therefore, tolerances for
potato chips, granules, flakes and processed potato waste are no longer
needed.
In an effort to achieve compatibility with Codex Maximum Residue
Levels (MRLs), EPA is proposing to decrease the tolerance in 40 CFR
180.364 (a) for residues of glyphosate -(phosphonomethyl)glycine
resulting from the application of glyphosate, the isopropylamine salt
of glyphosate, the ethanolamine salt of glyphosate, the ammonium salt
of glyphosate, and the potassium salt of glyphosate in or on kiwifruit
from 0.2 ppm to 0.1 ppm.
In an effort to achieve compatibility with Codex MRLs, EPA is
proposing to increase the tolerances in 40 CFR 180.364 (a) for residues
of glyphosate -(phosphonomethyl)glycine resulting from the application
of glyphosate, the isopropylamine salt of glyphosate, the ethanolamine
salt of glyphosate, the ammonium salt of glyphosate, and the potassium
salt of glyphosate in or on cattle, liver and hog, liver from 0.5 ppm
to 1.0 ppm. The Agency has 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.
EPA is proposing to revise 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;
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, legume, group 6 except soybean
to vegetable, legume, group 6, 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 tolerance reassessment in the RED proposed 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
proposing to remove 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.
The RED recommended that a crop group tolerance for, ``grass
forage, fodder and hay, group 17'' be established at 200 ppm. Since
then, the tolerance ``grass forage, fodder and hay, group 17'' was
established and increased to 300 ppm on September 27, 2002 due to
changes in the use patterns and pre-grazing intervals (67 FR 60934,
FRL-7200-2), and (65 FR 57957, FRL-6746-6).
Since the 1993 RED tolerance recommendations, multiple tolerance
actions have occurred to affect those original recommendations. The
tolerance levels and commodity names have changed due to commodity
terminology updates, crop group composition changes, adjustments in use
patterns or intervals of use, additional data submissions, and changes
in the tolerance expression in 40 CFR 180.364 for glyphosate (60 FR
45062, FRL-4962-1), (61 FR 7729, FRL-5351-5), (61 FR 15192, FRL-5351-
1), (62 FR 17723, FRL-5598-6), (63 FR 54058, FRL-6036-1), (64 FR 18360,
FRL-6073-5), (64 FR 41818, FRL-6096-2), (64 FR 66108, FRL-6390-5), (65
FR 57957, FRL-6746-6), (67 FR 60934, FRL-7200-2), (68 FR 36472, FRL-
7308-8), (68 FR 39460, FRL-7316-5, (69 FR 65081, FRL-7683-9), and (70
FR 7861, FRL-7697-7).
3. Difenzoquat. Based on available field trial data that indicate
residues of difenzoquat in or on barley grain were non-detectable
(<0.05 ppm), barley straw were as high as 4.0 ppm, and wheat straw were
as high as 4.2 ppm, the Agency determined that these tolerances should
be decreased to 0.05 ppm, 5.0 ppm, and 5.0 ppm, respectively.
Therefore, EPA is proposing to decrease 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 to 5.0 ppm; and wheat, straw from 20 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
[[Page 32902]]
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
proposing to establish 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 proposing to establish a tolerance in 40 CFR 180.369 for
residues of difenzoquat in or on barley, bran at 0.25 ppm.
4. Hexazinone. 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, and in plant commodities for regional tolerances in
40 CFR 180.396(c), should be modified to include all the specific
metabolites in plants, animal tissue and milk. Consequently, EPA is
proposing to separate and recodify plant, animal, and milk tolerances
from 180.396(a) to (a)(1), (a)(2), and (a)(3), respectively. Therefore,
EPA is proposing that the tolerance expressions in 40 CFR 180.396 read
as follows:
(a)(1) General. 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 food
commodities:
(a)(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:
(a)(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-1 [3-(2-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 (calculated as hexazinone) in milk: and
(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.
Based on available ruminant feeding data at exaggerated pesticide
dose levels and the maximum theoretical dietary burden, EPA determined
that there is no reasonable expectation of finite hexazinone residues
of concern in livestock from treated feed. At an exaggerated (62.5x)
feeding level, residues of hexazinone and its metabolites were non-
detectable; i.e., were below the combined limit of quantitation (LOQs)
of 0.1 ppm in fat. Therefore, the Agency determined that tolerances for
fat of cattle, goats, hogs, horses, and sheep are no longer needed
under 40 CFR 180.6(a)(3). As a result, EPA is proposing to revoke the
tolerances in 40 CFR 180.396 for combined hexazinone residues of
concern in or on cattle, fat; goat, fat; hog, fat; horse, fat; and
sheep, fat.
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.
After correction of the exaggerated feeding dose (640x) for hogs,
the Agency determined that residue levels of hexazinone and its
metabolites were non-detectable; i.e., were below the combined LOQs of
0.1 ppm in tissue. Therefore, the tolerances on hog meat and meat
byproducts are no longer needed under 40 CFR 180.6(a)(3). As a result
of the available ruminant feeding data and the enforcement method, EPA
is proposing to revoke the tolerances in 40 CFR 180.396 for combined
hexazinone residues of concern in or on hog, meat and hog, meat
byproducts.
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 proposing to increase 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 proposing to
increase 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 revise
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.
Available data indicate combined residues of hexazinone and its
regulated metabolites were <0.35 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
[[Page 32903]]
raw agricultural commodity (sugarcane, cane), it was below the current
tolerance level for sugarcane molasses and should be decreased to 4.0
ppm. Therefore, EPA is proposing to increase the tolerance for
sugarcane, cane and decrease the tolerance for sugarcane, molasses with
regional registration in 40 CFR 180.396(c), as defined in 180.1(n) and
which excludes use of hexazinone on sugarcane in Florida, for combined
hexazinone residues of concern in or on sugarcane, cane from 0.2 to 0.6
ppm and sugarcane molasses from 5.0 to 4.0 ppm, and revise 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.
Based on the available residue data, the TRED recommended
decreasing the tolerance in/on alfalfa hay contingent upon previously
requested label revisions by the registrant related to the pre-harvest
and pre-grazing intervals. The tolerance decrease is solely a
reflection of changes in the use pattern; the decrease is not required
for the tolerance to be safe. The Agency is in the process of following
up with the registrant and will address the tolerance modification in a
future Federal Register notice.
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 proposing to establish 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 proposing to revise commodity terminology to
conform to current Agency practice as follows: In 40 CFR 180.396(a)
alfalfa green forage to alfalfa, forage; grass, range to grass, forage;
and grass, pasture to grass, hay.
B. What is the Agency's Authority for Taking this Action?
A ``tolerance'' represents the maximum level for residues of
pesticide chemicals legally allowed in or on raw agricultural
commodities and processed foods. Section 408 of FFDCA, 21 U.S.C. 346a,
as amended by the FQPA of 1996, Public Law 104-170, authorizes the
establishment of tolerances, exemptions from tolerance requirements,
modifications in tolerances, and revocation of tolerances for residues
of pesticide chemicals in or on raw agricultural commodities and
processed foods. Without a tolerance or exemption, food containing
pesticide residues is considered to be unsafe and therefore,
``adulterated'' under section 402(a) of the FFDCA, 21 U.S.C. 342(a).
Such food may not be distributed in interstate commerce (21 U.S.C.
331(a)). For a food-use pesticide to be sold and distributed, the
pesticide must not only have appropriate tolerances under the FFDCA,
but also must be registered under FIFRA (7 U.S.C. 136 et seq.). Food-
use pesticides not registered in the United States must have tolerances
in order for commodities treated with those pesticides to be imported
into the United States.
EPA is proposing these tolerance actions 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 FQPA. The safety finding determination is discussed 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 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
requirements for additional data on the active ingredients to confirm
the potential human health and environmental risk assessments
associated with current product uses, and in 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 proposed
in this document do not need such assessment when the tolerances are no
longer necessary.
EPA's general practice is to propose revocation of tolerances for
residues of pesticide active ingredients on crops for which FIFRA
registrations no longer exist and on which the pesticide may therefore
no longer be used in the United States. EPA has historically been
concerned that retention of tolerances that are not necessary to cover
residues in or on legally treated foods may encourage misuse of
pesticides within the United States. Nonetheless, EPA will establish
and maintain tolerances even when corresponding domestic uses are
canceled if the tolerances, which EPA refers to as ``import
tolerances,'' are necessary to allow importation into the United States
of food containing such pesticide residues. However, where there are no
imported commodities that require these import tolerances, the Agency
believes it is appropriate to revoke tolerances for unregistered
pesticides in order to prevent potential misuse.
Furthermore, as a general matter, the Agency believes that
retention of import tolerances not needed to cover any imported food
may result in unnecessary restriction on trade of pesticides and foods.
Under section 408 of the FFDCA, a tolerance may only be established or
maintained if EPA determines that the tolerance is safe based on a
number of factors, including an assessment of the aggregate exposure to
the pesticide and an assessment of the cumulative effects of such
pesticide and other substances that have a common mechanism of
toxicity. In doing so, EPA must consider potential contributions to
such exposure from all tolerances. If the cumulative risk is such that
the tolerances in aggregate are not safe, then every one of these
tolerances is potentially vulnerable to revocation. Furthermore, if
unneeded tolerances are included in the aggregate and cumulative risk
assessments, the estimated exposure to the pesticide would be inflated.
Consequently, it may be more difficult for others to obtain needed
tolerances or to register needed new uses. To avoid potential trade
restrictions, the Agency is proposing to revoke tolerances for residues
on crops uses for which FIFRA registrations no longer exist, unless
someone expresses a need for such tolerances. Through this proposed
rule, the Agency is inviting individuals who need these import
tolerances to identify themselves and the tolerances that are needed to
cover imported commodities.
[[Page 32904]]
Parties interested in retention of the tolerances should be aware
that additional data may be needed to support retention. These parties
should be aware that, under FFDCA section 408(f), if the Agency
determines that additional information is reasonably required to
support the continuation of a tolerance, EPA may require that parties
interested in maintaining the tolerances provide the necessary
information. If the requisite information is not submitted, EPA may
issue an order revoking the tolerance at issue.
When EPA establishes tolerances for pesticide residues in or on raw
agricultural commodities, consideration must be given to the possible
residues of those chemicals 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). When
considering this possibility, EPA can conclude that:
1. Finite residues will exist in meat, milk, poultry, and/or eggs.
2. There is a reasonable expectation that finite residues will
exist.
3. There is a reasonable expectation that finite residues will not
exist. If there is no reasonable expectation of finite pesticide
residues in or on meat, milk, poultry, or eggs, tolerances do not need
to be established for these commodities (40 CFR 180.6(b) and (c)).
EPA has evaluated certain specific meat, milk, poultry, and egg
tolerances proposed for revocation in this rule and has concluded that
there is no reasonable expectation of finite pesticide residues of
concern in or on those commodities.
C. When do These Actions Become Effective?
EPA is proposing that these revocations, modifications,
establishments of tolerances, and commodity terminology revisions
become effective on the date of publication of the final rule in the
Federal Register. For this rule, proposed revocations will affect
tolerances for uses which have been canceled for many years or are no
longer needed. The Agency believes that treated commodities have had
sufficient time for passage through the channels of trade. However, if
EPA is presented with information that existing stocks would still be
available and that information is verified, the Agency will consider
extending the expiration date of the tolerance. If you have comments
regarding existing stocks and whether the effective date allows
sufficient time for treated commodities to clear the channels of trade,
please submit comments as described under SUPPLEMENTARY INFORMATION.
Any commodities listed in this proposal treated with the pesticides
subject to this proposal, and in the channels of trade following the
tolerance revocations, shall be subject to FFDCA section 408(1)(5), as
established by FQPA. Under this section, any residues of these
pesticides in or on such food shall not render the food adulterated so
long as it is shown to the satisfaction of the Food and Drug
Administration that: (1) The residue is present as the result of an
application or use of the pesticide at a time and in a manner that was
lawful under FIFRA, and (2) the residue does not exceed the level that
was authorized at the time of the application or use to be present on
the food under a tolerance or exemption from tolerance. Evidence to
show that food was lawfully treated may include records that verify the
dates when the pesticide was applied to such food.
D. What Is the Contribution to Tolerance Reassessment?
By law, EPA is required by August 3, 2006 to reassess the
tolerances in existence on August 2, 1996. As of April 19, 2006, EPA
has reassessed over 8,070 tolerances. Regarding tolerances mentioned in
this proposed rule, tolerances in existence as of August 2, 1996 were
previously counted as reassessed at the time of the signature
completion of a post-FQPA RED or TRED for each active ingredient.
Therefore, no further tolerance reassessments would be counted toward
the August 2006 review deadline.
III. Are The Proposed Actions Consistent with International
Obligations?
The tolerance revocations in this proposal are not discriminatory
and are designed to ensure that both domestically-produced and imported
foods meet the food safety standard established by the FFDCA. The same
food safety standards apply to domestically produced and imported
foods.
EPA is working to ensure that the U.S. tolerance reassessment
program under FQPA does not disrupt international trade. EPA considers
Codex MRLs in setting U.S. tolerances and in reassessing them. MRLs are
established by the Codex Committee on Pesticide Residues, a committee
within the Codex Alimentarius Commission, an international organization
formed to promote the coordination of international food standards. It
is EPA's policy to harmonize U.S. tolerances with Codex MRLs to the
extent possible, provided that the MRLs achieve the level of protection
required under FFDCA. EPA's effort to harmonize with Codex MRLs is
summarized in the tolerance reassessment section of individual
Reregistration Eligibility Decision documents. EPA has developed
guidance concerning submissions for import tolerance support in the
Federal Register of June 1, 2000 (65 FR 35069) (FRL-6559-3). This
guidance will be made available to interested persons. Electronic
copies are available on the internet at https://www.epa.gov/. On the
Home Page select ``Laws, Regulations, and Dockets,'' then select
``Regulations and Proposed Rules'' and then look up the entry for this
document under ``Federal Register''--Environmental Documents.'' You can
also go directly to the ``Federal Register'' listings at https://
www.epa.gov/fedrgstr/.
IV. Statutory and Executive Order Reviews
In this proposed rule, EPA is proposing to establish tolerances
under FFDCA section 408(e), and also modify and revoke 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 proposed rule has been exempted
from review under Executive Order 12866 due to its lack of
significance, this proposed rule is not subject to Executive Order
13211, Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This proposed
rule does not contain any information collections subject to OMB
approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., or impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA) (Public Law 104-4). Nor does it require any special
considerations as required by Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review
or any other Agency action under Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997).
[[Page 32905]]
This action does not involve any technical standards that would require
Agency consideration of voluntary consensus standards pursuant to
section 12(d) of the National Technology Transfer and Advancement Act
of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note). Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
et seq.), the Agency previously assessed whether 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 proposed rule, the Agency hereby certifies that this proposed
action will not have a significant negative 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 this proposed rule).
Furthermore, for the pesticide named in this proposed rule, the Agency
knows of no extraordinary circumstances that exist as to the present
proposal that would change the EPA's previous analysis. Any comments
about the Agency's determination should be submitted to the EPA along
with comments on the proposal, and will be addressed prior to issuing a
final rule. In addition, the Agency has determined that this action
will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132,entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This proposed rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of the FFDCA. For these same reasons, the Agency
has determined that this proposed rule does not have any ``tribal
implications'' as described in Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive Order 13175, requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by tribal officials in the development of regulatory policies that have
tribal implications.'' ``Policies that have tribal implications'' is
defined in the Executive order to include regulations that have
``substantial direct effects on one or more Indian tribes, on the
relationship between the Federal Government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes.'' This proposed rule will not have
substantial direct effects on tribal governments, on the relationship
between the Federal Government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this proposed rule.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: May 30, 2006.
James Jones,
Director, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR chapter I be amended as
follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
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
------------------------------------------------------------------------
* * * * *
3. In Sec. 180.364, the table in paragraph (a) is revised to read
as follows:
Sec. 180.364 Glyphosate; tolerances for residues.
(a) General. * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Acerola........................................ 0.2
Alfalfa, seed.................................. 0.5
Almond, hulls.................................. 25
Animal feed, nongrass, group 18................ 400
Aloe vera...................................... 0.5
Ambarella...................................... 0.2
Artichoke, globe............................... 0.2
Asparagus...................................... 0.5
Atemoya........................................ 0.2
Avocado........................................ 0.2
Bamboo, shoots................................. 0.2
Banana......................................... 0.2
Barley, bran................................... 30
[[Page 32906]]
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
Cactus, fruit.................................. 0.5
Cactus, pads................................... 0.5
Canistel....................................... 0.2
Canola, meal................................... 15
Canola, seed................................... 10
Cattle, kidney................................. 4.0
Cattle, liver.................................. 1.0
Chaya.......................................... 1.0
Cherimoya...................................... 0.2
Citrus, dried pulp............................. 1.5
Cacao bean..................................... 0.2
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..................... 100.0
Grain, cereal, forage, fodder and straw, group 100
16............................................
Grain, cereal, group 15, except barley, field 0.1
corn, grain 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..................................... 1.0
Hop, dried cones............................... 7.0
Horse, kidney.................................. 4.0
Horse, liver................................... 0.5
Ilama.......................................... 0.2
Imbe........................................... 0.2
Imbu........................................... 0.2
Jaboticaba..................................... 0.2
Jackfruit...................................... 0.2
Jojoba, seed................................... 0.1
Juneberry...................................... 0.2
Kava, roots.................................... 0.2
Kenaf, forage.................................. 200
Kiwifruit...................................... 0.1
Lesquerella, seed.............................. 0.1
Leucaena, forage............................... 200
[[Page 32907]]
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, seed.................................. 20
Soybean, forage................................ 100
Soybean, hay................................... 200
Soybean, hulls................................. 100
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
[[Page 32908]]
Ti, roots...................................... 0.2
Ugli fruit..................................... 0.5
Vegetable, brassica, leafy, group 5............ 0.2
Vegetable, bulb, group 3....................... 0.2
Vegetable, cucurbit, group 9................... 0.5
Vegetable, foliage of legume, subgroup 7A, 0.2
except soybean................................
Vegetable, fruiting, group 8................... 0.1
Vegetable, leafy, group 4...................... 0.2
Vegetable, leaves of root and tuber, group 2, 0.2
except sugar beet tops........................
Vegetable, legume, group 6, except soybean..... 5.0
Vegetable, root and tuber, group 1, except 0.2
sugar beet....................................
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
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