[Federal Register Volume 64, Number 134 (Wednesday, July 14, 1999)]
[Rules and Regulations]
[Pages 37855-37861]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-17352]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300879; FRL-6086-5]
RIN 2070-AB78
Imazamox; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes time-limited tolerances for
residues of imazamox, [2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-
1H-imidazol-2-yl]-5-methoxymethyl-3-pyridine-carboxylic acid, applied
as the free acid or ammonium salt in or on canola and dry beans. This
action is in response to EPA's granting of emergency exemptions under
section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act
authorizing use of the pesticide on canola and dry beans. This
regulation establishes a maximum permissible level for residues of
imazamox in these food commodities pursuant to section 408(l)(6) of the
Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality
Protection Act of 1996. The tolerances will expire and are revoked on
July 15, 2001.
DATES: This regulation is effective July 14, 1999. Objections and
requests for hearings must be received by EPA on or before September
13, 1999.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number [OPP-300879], must be submitted to: Hearing Clerk
(1900), Environmental Protection Agency, Rm. M3708, 401 M St., SW.,
Washington, DC 20460. Fees accompanying objections and hearing requests
shall be labeled ``Tolerance Petition Fees'' and forwarded to: EPA
Headquarters Accounting Operations Branch, OPP (Tolerance Fees), P.O.
Box 360277M, Pittsburgh, PA 15251. A copy of any objections and hearing
requests filed with the Hearing Clerk identified by the docket control
number, [OPP-300879], must also be submitted to: Public Information and
Records Integrity Branch, Information Resources and Services Division
(7502C), Office of Pesticide Programs, Environmental Protection Agency,
401 M St., SW., Washington, DC 20460. In person, bring a copy of
objections and hearing requests to Rm. 119, Crystal Mall #2, 1921
Jefferson Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: [email protected]. Copies of electronic objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect 5.1/6.1
or ASCII file format. All copies of electronic objections and hearing
requests must be identified by the docket control number [OPP-300879].
No Confidential Business Information (CBI) should be submitted through
e-mail. Copies of electronic objections and hearing requests on this
rule may be filed online at many Federal Depository Libraries.
FOR FURTHER INFORMATION CONTACT: By mail: Barbara Madden, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. Office
location, telephone number, and e-mail address: Rm. 284, Crystal Mall
#2, 1921 Jefferson Davis Hwy., Arlington, VA, (703) 305-6463,
[email protected].
SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to
section 408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA),
21 U.S.C. 346a, is establishing tolerances for residues of the
herbicide imazamox, in or on canola and dry beans at 0.05 part per
million (ppm). These tolerances will expire and are revoked on July 15,
2001. EPA will publish a document in the Federal Register to remove the
revoked tolerances from the Code of Federal Regulations.
I. Background and Statutory Findings
The Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170)
was signed into law August 3, 1996. FQPA amends both the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301 et seq., and the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et
seq. The FQPA amendments went into effect immediately. Among other
things, FQPA amends FFDCA to bring all EPA pesticide tolerance-setting
activities under a new section 408 with a new safety standard and new
procedures. These activities are described in this preeamble and
discussed in greater detail in the final rule establishing the time-
limited tolerance associated with the emergency exemption for use of
propiconazole on sorghum (61 FR 58135, November 13, 1996) (FRL-5572-9).
[[Page 37856]]
New section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue. . . .''
Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' This provision was not
amended by FQPA. EPA has established regulations governing such
emergency exemptions in 40 CFR part 166.
Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment.
Because decisions on section 18-related tolerances must proceed
before EPA reaches closure on several policy issues relating to
interpretation and implementation of the FQPA, EPA does not intend for
its actions on such tolerances to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions.
II. Emergency Exemptions for Imazamox on Canola and Dry Beans and
FFDCA Tolerances
Minnesota and North Dakota requested use of imazamox on canola for
control of wild mustard. According to the States, there are several
factors that have caused an increase in the wild mustard population
causing an emergency condition. First, there was above normal rainfall
in 4 of 5 years during 1993-1997 and very high rainfall in 1998.
Second, there has been an increase in the adoption of reduced-tillage
practices to conserve soil moisture and prevent soil erosion. Third,
there has been an increase in rotation to crops with limited or no
control options. Wild mustard emerges early in the spring and is very
competitive with canola. A canola crop containing 5% or more mustard
seed will likely be rejected. Weed control is essential for successful
oil seed crop production.
Currently there are no herbicides registered for use on canola that
control wild mustard. The Agency has issued emergency exemptions for
use of glufosinate-ammonium and glyphosate, which will also control
wild mustard; however, the States claim the total amount of product
available under those exemptions is not enough to control wild mustard
infestations in all the canola acreage. In-crop cultivation is not a
viable alternative for weed control since canola is commonly seeded in
narrow rows.
Colorado, Idaho, Minnesota, Montana, North Dakota and Wyoming
requested use of imazamox on dry beans for control of nightshade.
Nightshades and velvetleaf have become a severe problem in dry bean
production in parts of the Northwest and West Central United States.
Hairy and black nightshade germinate throughout the growing season and
can successfully tolerate shading. These characteristics allow plants
to survive most current control strategies and contaminate fields at
harvest. A single plant growing with crop competition can produce up to
1,600 berries per plant. The high moisture content of foliage and
berries results in significant reductions in harvest efficiency;
berries are poisonous and the purple-black juice from the berries
stains the beans and reduces quality. A zero tolerance is established
for dry beans grown for seed; one nightshade berry in a 300 pound
sample will result in the rejection of an entire field.
Nightshade and velvetleaf have become severe problems due to a
combination of reasons. Widespread use of trifluralin and pendimethalin
have effectively controlled many grass weed species but have caused an
increased prominence of nightshade. Frequent and thorough cultivations
have been effective nightshade tools but are unavailable in
conservation tillage. Only imazethapyr effectively controls nightshade
in dry beans. Imazethapyr is not registered for use on dry beans in
Idaho and Montana. Registrations are in place in Colorado, Minnesota,
North Dakota, and Wyoming.
Historically, the Agency has determined that crop rotation
restrictions are not a basis for an emergency when acceptable
alternatives exist. However, imazethapyr has plantback intervals for
sugar beets and canola of 40 months plus a successful field bioassy.
Dry beans are an important rotational crop of sugar beets because sugar
beets cannot be planted continuously due to nematode problems. The
States have argued and the Agency agrees that a 40-month plantback
restriction into an important cash crop for the region is equivalent to
not having a viable alternative.
EPA has authorized under FIFRA section 18 the use of imazamox on
canola for control of wild mustard in Minnesota and North Dakota, and
use of imazamox on dry beans for control of nightshade in Colorado,
Idaho, Minnesota, Montana, North Dakota, and Wyoming. After having
reviewed these submissions, EPA concurs that emergency conditions exist
for these States.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of imazamox in or on canola
and dry beans. In doing so, EPA considered the safety standard in FFDCA
section 408(b)(2), and EPA decided that the necessary tolerances under
FFDCA section 408(l)(6) would be consistent with the safety standard
and with FIFRA section 18. Consistent with the need to move quickly on
the emergency exemption in order to address an urgent non-routine
situation and to ensure that the resulting food is safe and lawful, EPA
is issuing this tolerance without notice and opportunity for public
comment under section 408(e), as provided in section 408(l)(6).
Although these tolerances will expire and are revoked on July 15, 2001,
under FFDCA section 408(l)(5), residues of the pesticide not in excess
of the amounts specified in the tolerance remaining in or on canola and
dry beans after that date will not be unlawful, provided the pesticide
is applied in a manner that was lawful under FIFRA, and the residues do
not exceed a level that was authorized by this tolerance at the time of
that application. EPA will take action to revoke this tolerance earlier
if any experience with, scientific data on, or other relevant
information on this pesticide indicate that the residues are not safe.
Because these tolerances are being approved under emergency
conditions, EPA has not made any decisions about whether imazamox meets
EPA's registration requirements for use on canola and dry beans or
whether
[[Page 37857]]
permanent tolerances for this use would be appropriate. Under these
circumstances, EPA does not believe that these tolerances serve as a
basis for registration of imazamox by a State for special local needs
under FIFRA section 24(c). Nor does this tolerance serve as the basis
for any State other than Colorado, Idaho, Minnesota, Montana, North
Dakota, and Wyoming to use this pesticide on these crops under section
18 of FIFRA without following all provisions of EPA's regulations
implementing section 18 as identified in 40 CFR part 166. For
additional information regarding these emergency exemptions for
imazamox, contact the Agency's Registration Division at the address
provided under the ``ADDRESSES'' section.
III. Aggregate Risk Assessment and Determination of Safety
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of imazamox
and to make a determination on aggregate exposure, consistent with
section 408(b)(2), for time-limited tolerances for residues of imazamox
on canola and dry beans at 0.05 ppm. EPA's assessment of the dietary
exposures and risks associated with establishing the tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by imazamox are
discussed in this unit.
B. Toxicological Endpoint
1. Acute toxicity. An acute reference dose (RfD) was not identified
for imazamox. No toxicity was seen at doses exceeding the highest dose
tested (HDT) in long-term studies in mice [no observed adverse effect
level (NOAEL) = 1,053 milligrams/kilograms/day (mg/kg/day)], rats
(NOAEL = 1,068 mg/kg/day) and dogs (NOAEL = 1156 mg/kg/day). No
developmental toxicity was seen at 1,000 mg/kg/day in rats and 900 mg/
kg/day in rabbits.
2. Short- and intermediate-term toxicity. Neither dermal nor
systemic toxicity was seen at the HDT of 1,000 mg/kg/day in a 28-day
dermal toxicity study in rats. Therefore, an endpoint was not
identified for short- and intermediate-term dermal or inhalation
exposure.
3. Chronic toxicity. EPA has established the RfD for imazamox at 3
mg/kg/day. This RfD is based on a NOAEL of 300 mg/kg/day from a
developmental toxicity study in rabbits. Effects seen at the lowest
observed adverse effect level (LOAEL), 600 mg/kg/day, were decreased
food consumption during the treatment period; at 900 mg/kg/day, body
weight gains were also reduced. An uncertainty factor of 100 (10X for
inter-species extrapolation and 10X for intra-species variability) was
applied to the NOAEL of 300 mg/kg/day to calculate the RfD of 3 mg/kg/
day. EPA has determined that the 10X factor to account for enhanced
susceptibility of infants and children, as required by FFDCA section
408(b)(2)(C), can be removed.
4. Carcinogenicity. Imazamox has been classified as a ``Not
Likely'' carcinogen.
C. Exposures and Risks
1. From food and feed uses. Tolerances have been established (40
CFR 180.508) for the residues of imazamox in or on soybeans. Risk
assessments were conducted by EPA to assess dietary exposures and risks
from imazamox as follows:
i. Acute exposure and risk. Acute dietary risk assessments are
performed for a food-use pesticide if a toxicological study has
indicated the possibility of an effect of concern occurring as a result
of a 1-day or single exposure. No toxicity was seen at doses exceeding
the HDT in long-term studies in mice, rats and dogs. No developmental
toxicity was seen at 1,000 mg/kg/day in rats and 900 mg/kg/day in
rabbits. Therefore, an acute RfD was not identified for imazamox and
acute dietary risk assessments were not conducted.
ii. Chronic exposure and risk. In conducting this chronic dietary
risk assessment, the following conservative assumptions have been made:
(1) all of the crops having imazamox tolerances will contain imazamox
residues, and (2) those residues will be at the level of the tolerance.
This results in an overestimation of human dietary exposure. Thus, in
making safety determinations for the canola and dry bean tolerances,
the Agency is taking into account this conservative exposure
assessment.
The combined imazamox tolerances (currently published and the
section 18 tolerances established by this action) result in a
Theoretical Maximum Residue Contribution (TMRC) that is less than 0.1%
of the RfD for the U.S. population and all population subgroups.
2. From drinking water. The Agency lacks sufficient water-related
exposure data to complete a comprehensive drinking water exposure
analysis and risk assessment for imazamox. Because the Agency does not
have comprehensive and reliable monitoring data, drinking water
concentration estimates must be made by reliance on some sort of
simulation or modeling. To date, there are no validated modeling
approaches for reliably predicting pesticide levels in drinking water.
The Agency is currently relying on Generic Expected Environmental
Concentration (GENEEC) and PRZM/EXAMS for surface water, which are used
to produce estimates of pesticide concentrations in a farm pond and
Screening Concentration in Ground Water (SCI-GROW), which predicts
pesticide concentrations in ground water. None of these models include
consideration of the impact processing of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever exceed human health levels of concern. For the proposed uses,
based on the GENEEC and SCI-GROW models, the chronic drinking water
concentration values are estimated to be 2 parts per billion (ppb) for
surface water and 3.4 pbb for ground water.
In the absence of monitoring data for pesticides, drinking water
levels of comparison (DWLOCs) are calculated and used as a point of
comparison against the model estimates of a pesticide's concentration
in water. DWLOCs are theoretical upper limits on a pesticide's
concentration in drinking water in light of total aggregate exposure to
a pesticide in food, drinking water, and residential uses. A DWLOC will
vary depending on the toxic endpoint, with drinking water consumption,
and body weights. Different populations will have different DWLOCs.
DWLOCs are used in the risk assessment process as a surrogate measure
of potential exposure associated with pesticide
[[Page 37858]]
exposure through drinking water. DWLOC values are not regulatory
standards for drinking water. Since DWLOCs address total aggregate
exposure to imazamox, they are further discussed in the aggregate risk
sections below.
3. From non-dietary exposure. Imazamox is not registered on any use
sites which would result in non-dietary, non-occupational exposure.
Therefore, EPA expects only dietary and occupational exposure from the
use of imazamox.
4. Cumulative exposure to substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
EPA does not have, at this time, available data to determine
whether imazamox has a common mechanism of toxicity with other
substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
imazamox does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance action, therefore,
EPA has not assumed that imazamox has a common mechanism of toxicity
with other substances. For more information regarding EPA's efforts to
determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see the final rule
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).
D. Aggregate Risks and Determination of Safety for U.S. Population
1. Acute risk. An acute RfD was not identified for imazamox;
therefore, acute dietary risk assessments were not conducted.
2. Chronic risk. Using the TMRC exposure assumptions described
above, EPA has concluded that aggregate exposure to imazamox from food
will utilize less than 0.1% of the RfD for the U.S. population. The
major identifiable subgroup with the highest aggregate exposure is non-
nursing infants less than 1 year old (discussed below). EPA generally
has no concern for exposures below 100% of the RfD because the RfD
represents the level at or below which daily aggregate dietary exposure
over a lifetime will not pose appreciable risks to human health.
Despite the potential for exposure to imazamox in drinking water, after
calculating a DWLOC (90,000 ppb) for the U.S. population and comparing
it to conservative model estimates of concentrations of imazamox in
surface and ground water (2 ppb and 3.4 pbb, respectively), EPA does
not expect the aggregate exposure to exceed 100% of the RfD.
3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account chronic dietary food and water
(considered to be a background exposure level) plus other indoor and
outdoor non-occupational exposure. Since there are no non-dietary, non-
occupational exposures expected from the use of this chemical, no
short- and intermediate-term risk assessments were conducted.
4. Aggregate cancer risk for U.S. population. Imazamox has been
classified as a ``Not Likely'' carcinogen; therefore, a cancer risk
assessment was not conducted.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
from aggregate exposure to imazamox residues.
E. Aggregate Risks and Determination of Safety for Infants and Children
1. Safety factor for infants and children-- i. In general. In
assessing the potential for additional sensitivity of infants and
children to residues of imazamox, EPA considered data from
developmental toxicity studies in the rat and rabbit and a 2-generation
reproduction study in the rat. The developmental toxicity studies are
designed to evaluate adverse effects on the developing organism
resulting from maternal pesticide exposure during gestation.
Reproduction studies provide information relating to effects from
exposure to the pesticide on the reproductive capability of mating
animals and data on systemic toxicity.
FFDCA section 408 provides that EPA shall apply an additional
tenfold margin of safety for infants and children in the case of
threshold effects to account for pre- and postnatal toxicity and the
completeness of the data base unless EPA determines that a different
margin of safety will be safe for infants and children. Margins of
safety are incorporated into EPA risk assessments either directly
through use of a margin of exposure (MOE) analysis or through using
uncertainty (safety) factors in calculating a dose level that poses no
appreciable risk to humans. EPA believes that reliable data support
using the standard MOE and uncertainty factor (usually 100 for combined
inter- and intra-species variability) and not the additional tenfold
MOE/uncertainty factor when EPA has a complete data base under existing
guidelines and when the severity of the effect in infants or children
or the potency or unusual toxic properties of a compound do not raise
concerns regarding the adequacy of the standard MOE/safety factor.
ii. Developmental toxicity studies. In the developmental study in
rats, the maternal (systemic) NOAEL was 500 mg/kg/day, based on minimal
decreases in maternal body weight gains during the treatment period at
the LOAEL of 1,000 mg/kg/day. The developmental (fetal) NOAEL was
1,000 mg/kg/day, the highest dose level tested. In the
developmental toxicity study in rabbits, the maternal (systemic) NOAEL
was 300 mg/kg/day, based on decreased food consumption at the LOAEL of
600 mg/kg/day. The developmental (pup) NOAEL was 900 mg/kg/
day, the highest dose level tested.
iii. Reproductive toxicity study. In the 2-generation reproductive
toxicity study in rats, the systemic and reproductive NOAEL was
1,705/1,469 mg/kg/day for M/F, the highest dose level
tested. The developmental (pup) NOAEL was 1,469 mg/kg/day, the highest
dose level tested.
iv. Pre- and postnatal sensitivity. The toxicological data base for
evaluating pre- and postnatal toxicity for imazamox is complete with
respect to current data requirements. There are no pre- or postnatal
toxicity concerns for infants and children, based on the results of the
rat and rabbit developmental toxicity studies and the 2-generation rat
reproductive toxicity study.
v. Conclusion. There is a complete toxicity data base for imazamox
and exposure data are complete or are estimated based on data that
reasonably accounts for potential exposures. The Agency concludes that
reliable data support use of a 100-fold margin of exposure/uncertainty
factor, rather than the standard 1,000-fold margin/factor, to protect
infants and children.
2. Acute risk. An acute RfD was not identified for imazamox;
therefore, acute dietary risk assessments were not conducted.
3. Chronic risk. Using the TMRC exposure assumptions described
above, EPA has concluded that aggregate exposure to imazamox from food
will utilize less than 0.1% of the RfD for infants and children. EPA
generally has no concern for exposures below 100% of the RfD because
the RfD represents the level at or below which daily aggregate dietary
exposure over a lifetime will not pose appreciable risks to human
health. Despite the potential for exposure to imazamox in drinking
[[Page 37859]]
water, after calculating a DWLOC (30,000 ppb) for non-nursing infants
less than 1 year old, the major identifiable subgroup with the highest
aggregate exposure and comparing it to conservative model estimates of
concentrations of imazamox in surface and ground water (2 ppb and 3.4
pbb, respectively), EPA does not expect the aggregate exposure to
exceed 100% of the RfD.
4. Short- or intermediate-term risk. There are no non-dietary, non-
occupational exposures expected from the use of imazamox; therefore, no
short- and intermediate-term risk assessments were conducted.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to infants and children from aggregate exposure to imazamox residues.
IV. Other Considerations
A. Metabolism In Plants and Animals
The nature of the residue in soybeans data were reviewed in
conjunction with a registration for use of imazamox on soybeans under
FIFRA section 3. The soybean metabolism data were adequate to determine
that the residue of concern is imazamox on soybeans. For these section
18's on canola and dry beans, the regulated residue is imazamox per se.
The nature of the residue in animals (poultry and ruminants) data
were also reviewed in conjunction with the petition for soybeans. It
was determined that no detectable imazamox residues would be expected
in any animal commodities; therefore, no tolerances for any animal
commodities were needed. Use of canola or dry beans as a feed item is
expected to result in a similar or lower dietary burden as soybeans.
Therefore, no tolerances are required for any animal commodities to
support these commodities.
B. Analytical Enforcement Methodology
Adequate enforcement methodology (residue analytical methods
M2248.01 and M2333 using HPLC/UV and HPLC/MS, respectively, have been
validated by EPA's Analytical Chemistry Branch and is available to
enforce the tolerance expression for soybeans. For canola and dry
beans, the registrant proposes a capillary electrophoresis method (M-
3076) that has the same LOQ as the previously validated UV and MS
methods (0.05 ppm). This method is considered acceptable for the
current section 18 registration.
C. Magnitude of Residues
Residues of imazamox are not expected to exceed 0.05 ppm in/on
canola or dry beans as a result of these section 18 uses. Based on
metabolism studies on goats and hens, the Agency concludes that for
these section 18 uses there are no reasonable expectation of finite
residues of imazamox per se in meat, milk, poultry and eggs; therefore,
tolerances for these commodities are not required at this time.
D. International Residue Limits
Imazamox is registered for use in canola in Canada. There are no
Codex MRLs and no Mexican uses, as of 1998.
E. Rotational Crop Restrictions
Data that examined the potential for accumulation of [6-pyridine-
14C]imazamox in rotational crops indicate that
14C-residues of imazamox did not accumulate (<0.01 ppm) in/
on wheat commodities planted 100 days after sandy loam soil treatment
at the 1.6X rate with [6-pyridine-14C]imazamox. At the 268-
day rotation, radioactive residues were less than 0.01 ppm in/on
radish, lettuce, and corn commodities. Tolerances on rotational crops
need not be established. Available data support a 3-month plantback
interval for wheat, 4-month plantback interval for barley and rye, and
the 9-month plantback interval for alfalfa, beans, corn, cotton, oats,
peas, peanuts, potatoes, rice, sorghum (grain) and tobacco. Based on
the residue data, the plantback intervals for all other crops could be
9 months, however, due to phytotoxicity concerns, some plantback
restrictions are longer than 9 months.
V. Conclusion
Therefore, tolerances are established for residues of imazamox in
canola and dry bean at 0.05 ppm.
VI. Objections and Hearing Requests
The new FFDCA section 408(g) provides essentially the same process
for persons to ``object'' to a tolerance regulation as was provided in
the old section 408 and in section 409. However, the period for filing
objections is 60 days, rather than 30 days. EPA currently has
procedural regulations which govern the submission of objections and
hearing requests. These regulations will require some modification to
reflect the new law. However, until those modifications can be made,
EPA will continue to use those procedural regulations with appropriate
adjustments to reflect the new law.
Any person may, by September 13, 1999, file written objections to
any aspect of this regulation and may also request a hearing on those
objections. Objections and hearing requests must be filed with the
Hearing Clerk, at the address given under the ``ADDRESSES'' section (40
CFR 178.20). A copy of the objections and/or hearing requests filed
with the Hearing Clerk should be submitted to the OPP docket for this
rulemaking. The objections submitted must specify the provisions of the
regulation deemed objectionable and the grounds for the objections (40
CFR 178.25). Each objection must be accompanied by the fee prescribed
by 40 CFR 180.33(i). EPA is authorized to waive any fee requirement
``when in the judgement of the Administrator such a waiver or refund is
equitable and not contrary to the purpose of this subsection.'' For
additional information regarding tolerance objection fee waivers,
contact James Tompkins, Registration Division (7505C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. Office location, telephone number, and e-mail
address: Rm. 239, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, (703) 305-5697, [email protected]. Requests for
waiver of tolerance objection fees should be sent to James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460.
If a hearing is requested, the objections must include a statement
of the factual issues on which a hearing is requested, the requestor's
contentions on such issues, and a summary of any evidence relied upon
by the requestor (40 CFR 178.27). A request for a hearing will be
granted if the Administrator determines that the material submitted
shows the following: There is genuine and substantial issue of fact;
there is a reasonable possibility that available evidence identified by
the requestor would, if established, resolve one or more of such issues
in favor of the requestor, taking into account uncontested claims or
facts to the contrary; and resolution of the factual issues in the
manner sought by the requestor would be adequate to justify the action
requested (40 CFR 178.32). Information submitted in connection with an
objection or hearing request may be claimed confidential by marking any
part or all of that information as CBI. Information so marked will not
be disclosed except in accordance with procedures set forth in 40 CFR
part 2. A copy of the information that does not contain CBI must be
submitted for inclusion in the public record.
[[Page 37860]]
Information not marked confidential may be disclosed publicly by EPA
without prior notice.
VII. Public Record and Electronic Submissions
EPA has established a record for this regulation under docket
control number [OPP-300879] (including any comments and data submitted
electronically). A public version of this record, including printed,
paper versions of electronic comments, which does not include any
information claimed as CBI, is available for inspection from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The public
record is located in Room 119 of the Public Information and Records
Integrity Branch, Information Resources and Services Division (7502C),
Office of Pesticide Programs, Environmental Protection Agency, Crystal
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
Objections and hearing requests may be sent by e-mail directly to
EPA at:
[email protected]
E-mailed objections and hearing requests must be submitted as an
ASCII file avoiding the use of special characters and any form of
encryption.
The official record for this regulation, as well as the public
version, as described in this unit will be kept in paper form.
Accordingly, EPA will transfer any copies of objections and hearing
requests received electronically into printed, paper form as they are
received and will place the paper copies in the official record which
will also include all comments submitted directly in writing. The
official record is the paper record maintained at the Virginia address
in ``ADDRESSES'' at the beginning of this document.
VIII. Regulatory Assessment Requirements
A. Certain Acts and Executive Orders
This final rule establishes a tolerance under section 408 of the
FFDCA. The Office of Management and Budget (OMB) has exempted these
types of actions from review under Executive Order 12866, entitled
Regulatory Planning and Review (58 FR 51735, October 4, 1993). This
final rule does not contain any information collections subject to OMB
approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., or impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA) (Public Law 104-4). Nor does it require any special
considerations as required by Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994), or require OMB
review in accordance with Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997).
In addition, since tolerances and exemptions that are established
on the basis of a petition under FFDCA section 408(l)(6), such as the
tolerance in this final rule, do not require the issuance of a proposed
rule, the requirements of the Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.) do not apply. Nevertheless, the Agency previously
assessed whether establishing tolerances, exemptions from tolerances,
raising tolerance levels or expanding exemptions might adversely impact
small entities and concluded, as a generic matter, that there is no
adverse economic impact. The factual basis for the Agency's generic
certification for tolerance actions published on May 4, 1981 (46 FR
24950), and was provided to the Chief Counsel for Advocacy of the Small
Business Administration.
B. Executive Order 12875
Under Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may
not issue a regulation that is not required by statute and that creates
a mandate upon a State, local or tribal government, unless the Federal
government provides the funds necessary to pay the direct compliance
costs incurred by those governments. If the mandate is unfunded, EPA
must provide to OMB a description of the extent of EPA's prior
consultation with representatives of affected State, local, and tribal
governments, the nature of their concerns, copies of any written
communications from the governments, and a statement supporting the
need to issue the regulation. In addition, Executive Order 12875
requires EPA to develop an effective process permitting elected
officials and other representatives of State, local, and tribal
governments ``to provide meaningful and timely input in the development
of regulatory proposals containing significant unfunded mandates.''
Today's rule does not create an unfunded Federal mandate on State,
local, or tribal governments. The rule does not impose any enforceable
duties on these entities. Accordingly, the requirements of section 1(a)
of Executive Order 12875 do not apply to this rule.
C. Executive Order 13084
Under Executive Order 13084, entitled Consultation and Coordination
with Indian Tribal Governments (63 FR 27655, May 19, 1998), EPA may not
issue a regulation that is not required by statute, that significantly
or uniquely affects the communities of Indian tribal governments, and
that imposes substantial direct compliance costs on those communities,
unless the Federal government provides the funds necessary to pay the
direct compliance costs incurred by the tribal governments. If the
mandate is unfunded, EPA must provide OMB, in a separately identified
section of the preamble to the rule, a description of the extent of
EPA's prior consultation with representatives of affected tribal
governments, a summary of the nature of their concerns, and a statement
supporting the need to issue the regulation. In addition, Executive
Order 13084 requires EPA to develop an effective process permitting
elected officials and other representatives of Indian tribal
governments ``to provide meaningful and timely input in the development
of regulatory policies on matters that significantly or uniquely affect
their communities.''
Today's rule does not significantly or uniquely affect the
communities of Indian tribal governments. This action does not involve
or impose any requirements that affect Indian tribes. Accordingly, the
requirements of section 3(b) of Executive Order 13084 do not apply to
this rule.
IX. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the Agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and the Comptroller General of the United
States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. This rule is not a
``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
[[Page 37861]]
Dated: June 28, 1999.
James Jones,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180-[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a, 321q and 371.
2. In Sec. 180.508, by adding paragraph (b) to read as follows:
Sec. 180.508 Imazamox; tolerances for residues.
(a) * * *
(b) Section 18 emergency exemptions. Time-limited tolerances are
established for residues of imazamox, [2-[4,5-dihydro-4-methyl-4-(1-
methylethyl)-5-oxo-1H-imidazol-2-yl]-5-methoxymethyl-3-pyridine-
carboxylic acid, applied as the free acid or ammonium salt in
connection with use of the herbicide under section 18 emergency
exemptions granted by EPA. Tolerances will expire and are revoked on
the dates specified in the following table.
------------------------------------------------------------------------
Parts Expiration/
Commodity per revocation
million date
------------------------------------------------------------------------
Beans, dry........................................ 0.05 7/15/01
Canola............................................ 0.05 7/15/01
------------------------------------------------------------------------
* * * * *
[FR Doc. 99-17352 Filed 7-13-99; 8:45 am]
BILLING CODE 6560-50-F