[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