[Federal Register Volume 62, Number 105 (Monday, June 2, 1997)]
[Rules and Regulations]
[Pages 29669-29673]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-14301]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300502; FRL-5721-1]
RIN 2070-AB78


Imazamox; Pesticide Tolerance

Agency: Environmental Protection Agency (EPA).
ACTION: Final Rule.
SUMMARY: This document establishes tolerances for the residues of the 
herbicide imazamox, [2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-
1H-imidazol-2-yl]-5-methoxymethyl-3-pyridinecarboxylic acid] (PC Code 
No. 129171, CAS No. 114311-32-9), applied as the free acid or ammonium 
salt, in or on soybean seed. American Cyanamid submitted a petition to 
EPA under the Federal Food, Drug, and Cosmetic Act as amended by the 
Food Quality Protection Act of 1996 requesting the tolerances.

DATE: This rule becomes effective June 2, 1997. Objections and requests 
for hearings must be received by EPA on or before August 1, 1997.



ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300502], may 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 should be identified by the 
docket control number [OPP-300502] must also be submitted to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7506C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. In person, 
bring copy of objections and hearing requests to: Rm. 1132, CM 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:

[[Page 29670]]

[email protected]. Copies of 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 in 5.1 file 
format or ASCII file format. All copies of objections and hearing 
requests in electronic form must be identified by the docket number 
[OPP-300502]. No Confidential Business Information (CBI) should be 
submitted through e-mail. Electronic copies of objections and hearing 
requests on this rule may be filed online at many Federal Depository 
Libraries.

FOR FURTHER INFORMATION CONTACT: By Mail: Jim Tompkins, Product Manager 
(PM)25, 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. 241, CM 2, 
1921 Jefferson Davis Hwy., Arlington, VA (703) 305-6027; e-mail: 
[email protected].


SUPPLEMENTARY INFORMATION: In the Federal Register of December 26, 1996 
(61 FR 68036) EPA issued a notice announcing that American Cyanamid, 
P.O. Box 400, Princeton, NJ 08543 had submitted pesticide petition 
6F4649 to EPA which requested that the Administrator, pursuant to 
section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), and 
the Food Quality Protection Act (FQPA) of 1996, amend 40 CFR part 180 
to establish tolerances for residues of the herbicide imazamox, [2-
[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-yl]-5-
methoxymethyl-3-pyridinecarboxylic acid], applied as the ammonium salt, 
in or on soybean seed at 0.1 parts per million (ppm). This notice 
contained a summary of the petition prepared by the petitioner and the 
summary contained conclusions that the petition complied with FPQA.
    There were no comments received in response to the notice of 
filing.
    The data submitted in the petition and other relevant material have 
been evaluated. The toxicological data listed below were considered in 
support of this tolerance.

I. Toxicology Profile

    1. A battery of acute toxicity studies placing technical imazamox 
in toxicity category III for eye irritation, and acute dermal 
LD50 and category IV for acute oral LD50, primary 
skin irritation, and acute inhalation LD50. Imazamox did not 
cause any dermal sensitization.
    2. A 90-day rat feeding study at doses of 0, 1,000, 10,000, or 
20,000 ppm (0, 81, 833, or 1,661 milligrams per kilogram per day (mg/
kg/day)) showed no signs of mortality, abnormal clinical signs or 
ophthalmological findings. The NOEL was 20,000 ppm (1,661 mg/kg/day), 
the highest dose tested (HDT).
    3. A 90-day subchronic dog feeding study at doses of 0, 1,000, 
10,000 or 40,000 ppm (males = 0, 34, 329, or 1,333; females = 0, 36, 
381, or 1,403 mg/kg/day) showed no clinical or ophthalmological effects 
up to 40,000 ppm. The NOEL was set at 40,000 ppm (1.3 mg/kg/day for 
males and 1.4 mg/kg/day for females) HDT.
    4. A 28-day repeated dose dermal toxicity study in rats at doses of 
0, 250, 500, or 1,000 mg/kg/day showed no clinical signs of toxicity, 
nor differences in ophthalmology, hematology parameters, clinical blood 
chemistry, organ weights, or macroscopic or microscopic organ 
morphology. The NOEL was determined to be 1,000 mg/kg/day (HDT).
    5. A 1-year dog chronic toxicity study at doses of 0, 1,000, 
10,000, or 40,000 ppm (0, 29.5, 282.5, or 1,165 mg/kg/day) HDT showed 
no clinical signs of toxicity, nor differences in ophthalmology, 
hematology parameters, clinical blood chemistry, organ weights, or 
macroscopic or microscopic organ pathology. The NOEL was determined to 
be 40,000 ppm (1,165 mg/kg/day) HDT.
    6. A 2-year rat chronic/carcinogenicity study at doses of 0, 1,000, 
10,000, or 20,000 ppm (males= 0, 52, 528, or 1,068 mg/kg/day; females = 
0, 63, 626, or 1,284 mg/kg/day) showed no clinical or ophthalmological 
effects other than increased kidney weights. However, this was not 
dose-related and no corroborative macroscopic or histopathological 
changes were detected in the kidneys. The NOEL was determined to be 
20,000 ppm (1,068 mg/kg/day in males and 1,284 in females) HDT.
    7. A rat developmental toxicity study at doses of 0, 100, 500, or 
1,000 mg/kg/day. At 1,000 mg/kg/day, the only clinical sign of toxicity 
was mean body weight gain. However, the differences were comparable 
between treated and control groups during the later and post dosage 
periods. The NOEL for maternal toxicity is 500 mg/kg/day based on body 
weight effects. The LOEL is 1,000 mg/kg/day. There were no treatment 
related developmental effects, therefore the developmental toxicity 
NOEL is > 1,000 mg/kg/day (limit dose); a LOEL was not established.
    8. A rabbit developmental toxicity study at doses of 0, 300, 600, 
or 900 mg/kg/day with a maternal NOEL of 300 mg/kg/day based on reduced 
body weights and reduced food consumption and developmental NOEL of 900 
mg/kg/day (HDT).
    9. A rat 2-generation reproduction study at dietary concentrations 
of 0, 1,000, 10,000, or 20,000 ppm (males= 0, 73 748 or 1,469 mg/kg/
day; females = 0, 88, 892, or 1,826 mg/kg/day) with a NOEL of 20,000 
ppm (HDT).
    10. A metabolism study in rats indicated that imazamox was rapidly 
absorbed and excreted within 7 days post-dosing, with the majority of 
the administered 14C-label (> 73%) eliminated in the urine 
within 24 hours. Metabolite characterization studies showed that 
essentially all the test material was excreted unchanged. Three minor 
metabolites, CL 263284 and CL 312622, and CL 303190 were detected in 
the urine of treated rats; however, their total contribution combined 
was less than or equal to 2.0% of the administered dose. HPLC/MS 
Analysis of the feces identified CL 263,284 (9%), CL 312,622 (3%), and 
N-methyl CL 299,263 (in trace amounts).
    11. Acceptable studies on gene mutation and other genotoxic 
effects: Ames Salmonella Assay; CHO/HGPRT Point Mutation Assay; In 
vitro CHO cell chromosome aberration assay; Dominant lethal assay; and 
Unscheduled DNA synthesis (UDS) yielded negative results.

II. Dose Response Assessment

    1. Reference dose (RfD). The RfD represents the level at or below 
which daily aggregate dietary exposure over a lifetime will not pose 
appreciable risks to human health. The RfD is determined by using the 
toxicological end-point or the NOEL for the most sensitive mammalian 
toxicological study. To assure the adequacy of the RfD, the Agency uses 
an uncertainty factor in deriving it. The factor is usually 100 to 
account for both interspecies extrapolation and intraspecies 
variability represented by the toxicological data. The EPA has 
established an RfD of 3.00 mg/kg/day based on a NOEL of 300 mg/kg/day 
from the rabbit developmental toxicity study.
    2. Carcinogenicity classification. Using the Guidelines for 
Carcinogenic Risk Assessment published September 24, 1986 (51 FR 
33992), the EPA has classified imazamox as Group ``E'', not a likely 
human carcinogen.
    3. Developmental toxicant determination. The acceptable 
developmental studies (two-generation reproduction study in rats and 
prenatal developmental toxicity studies in rats and rabbits) provided 
no indication of

[[Page 29671]]

increased sensitivity of rats or rabbits to in utero and/or postnatal 
exposure to imazamox.

III. Non-dietary (Residential and Occupational) Exposure Assessment

    As part of the hazard assessment process, the Agency reviews the 
available toxicological database to determine if there are 
toxicological endpoints of concern. For imazamox, the Agency does not 
have a concern for short-term, intermediate-term, or chronic-term 
occupational or residential exposure since the available toxicology 
data indicates minimal toxicity only at a very high dose, such as the 
limit dose by the dermal or inhalation routes. Therefore, occupational 
or residential risk assessments are not required.

IV. Dietary Exposure Assessment

    Use of an agricultural pesticide may result, directly or 
indirectly, in pesticide residues in food. Primary residues or 
indirect/inadvertent residues in food commodities are determined by 
chemical analysis. To account for the diversity of growing conditions, 
cultural practices, soil types, climates, crop varieties and methods of 
application of the pesticide, data from studies that represent the 
commodities are collected and evaluated to determine an appropriate 
level of residue that would not be exceeded if the pesticide is used as 
represented in the studies.
    1. Plant/animal metabolism and magnitude of the residue. The nature 
(metabolism) of imazamox in plants and animals is adequately understood 
for the purposes of these tolerances. There are no Codex maximum 
residue levels established for residues of imazamox on soybeans or the 
rotational crops. In all the plant and animal (poultry and ruminants) 
metabolism studies submitted, the residue of concern was the parent per 
se, imazamox.
    2. Residue analytical methods. The analytical method proposed as an 
enforcement method for soybean commodities is GS/MS Method M 2248.01. 
The method is suitable for detecting residues of the parent compound, 
imazamox, in soybean seeds. Tolerances for meat, milk, poultry, and 
eggs, are not required for this petition, therefore, an analytical 
method for the enforcement of animal tolerances is not needed.

V. Aggregate Exposure Assessment

    In examining aggregate exposure, FQPA directs EPA to consider 
available information concerning exposures from pesticide residue in 
food, including water, and all other nonoccupational exposures. The 
aggregate sources of exposure the Agency looks at includes food, 
drinking water or groundwater, and exposure from pesticide use in 
gardens, lawns, or buildings (residential and other indoor uses).
    1. Acute dietary. As part of the hazard assessment process, the 
Agency reviews the available toxicology database to determine the 
endpoints of concern. For imazamox, the Agency does not have a concern 
for an acute dietary risk since the available data do not indicate any 
evidence of significant toxicity from a 1 day or single event exposure 
by the oral route. Therefore, an acute dietary risk assessment was not 
required.
    2. Chronic dietary. Using the Dietary Risk Evaluation System 
(DRES), a chronic exposure analysis was performed using tolerance level 
residues and 100 percent crop treated to estimate the Theoretical 
Maximum Residue Contribution (TMRC) for the general population and 22 
subgroups. This exposure analysis showed that exposure from residues 
in/on soybeans in the U.S. population and all subgroups would be less 
than 1% of the RfD.
    3. Drinking water. To determine the exposure from drinking water, 
the Agency applied modeling procedures. Using the estimated chronic 
drinking water values of 1 g/L for surface water, the exposure 
to imazamox from drinking water was calculated to be 2  x  
10-5 milligram per kilogram of body weight per day (mg/kg 
bw/day) for the U.S. population (Surface Water), 4  x  10-5 
mg/kg bw/day for non-nursing infants (Surface Water), and 4  x  
10-5 mg/kg bw/day for children (1 to 6 years old). These 
drinking water values were developed for use in ecorisk assessment and 
represent a reasonable upper-bound estimate for eco-risk assessment. It 
is expected that they represent an overestimate for human health risk 
assessments. The chronic dietary analysis is also an upper-bound 
estimate of dietary exposure with all residues at tolerance level and 
100 percent of the commodity assumed to be treated with imazamox. 
Therefore, even without refinements, EPA does not consider the combined 
aggregate chronic dietary/drinking water risk to exceed the level of 
concern.
    4. Non-dietary (residential and non-occupational) exposure. There 
are no residential uses for imazamox and it is not likely to be applied 
in or near residential areas; therefore, non-occupational non-dietary 
exposure is not expected.
    5. Cumulative exposure to substances with 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.'' The Agency believes that ``available 
information'' in this context might include not only toxicity, 
chemistry, and exposure data, but also scientific policies and 
methodologies for understanding common mechanisms of toxicity and 
conducting cumulative risk assessments. For most pesticides, although 
the Agency has some information in its files that may be helpful in 
determining whether a pesticide shares a common mechanism of toxicity 
with any other substances, EPA does not at this time have the 
methodology to resolve the scientific issues concerning common 
mechanism of toxicity in a meaningful way. EPA has begun a pilot 
process to study this issue further through examination of particular 
classes of pesticides. The Agency hopes that the results of this pilot 
process will increase the Agency`s scientific understanding of this 
question such that EPA will be able to develop and apply scientific 
principles for better determining which chemicals have a common 
mechanism of toxicity and evaluating the cumulative effects of such 
chemicals. The Agency anticipates, however, that even as its 
understanding of the science of common mechanisms increases, decisions 
on specific classes of chemicals will be heavily dependent on chemical 
specific data, much of which may not be presently available.
    Although, at present, the Agency does not know how to apply the 
information in its files concerning common mechanism issues to most 
risk assessments, there are pesticides as to which the common 
mechanisms issues can be resolved. These pesticides include pesticides 
that are toxicologically dissimilar to existing chemical substances (in 
which the Agency can conclude that it is unlikely that a pesticide 
shares a common mechanism of activity with other substances) and 
pesticides that produce a common toxic metabolite (in which case common 
mechanism of activity will be assumed).
    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, imazamox does not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has not

[[Page 29672]]

assumed that imazamox has a common mechanism of toxicity with other 
substances.

VI. Determination of Safety for the U.S. Population and Non-Nursing 
Infants

    Using the Dietary Risks Evaluation System (DRES) a chronic dietary 
analysis was performed based on 100% of the crop treated and all 
residues at tolerance levels. Based on the dietary risk assessment, the 
proposed uses utilize less than 1% of the RfD for the U.S. population; 
less than 1% of the RfD for non-nursing infants under 1 year old; less 
than 1% for nursing infants under 1 year old; less than 1% for children 
1 to 6 years old; and less than 1% for children 7 to 12 years old. The 
Agency concluded that there is a reasonable certainty that no harm will 
occur to non-nursing infants, or any other members of the U.S. 
population from aggregate exposure to imazamox.

VII. Determination of Safety for Infants and Children

    Risk to infants and children was determined by the use of two 
developmental toxicity studies in rats and rabbits and the two-
generation reproduction study in rats discussed below. The 
developmental toxicity studies evaluates the potential for adverse 
effects on the developing organism resulting from exposure during 
prenatal development. The reproduction study provides information 
relating to effects from exposure to the chemical on the reproductive 
capability of both (mating) parents and on systemic toxicity.
    The toxicological database for evaluating pre-and post-natal 
toxicity for imazamox is considered to be complete at this time. In the 
rabbits, the maternal LOEL was 600 mg/kg/day based on reduced food 
consumption. The maternal NOEL of 300 mg/kg/day was established based 
on reduced body weight gains and reduced food consumption. The 
developmental toxicity NOEL was set at 900 mg/kg/day, the highest dose 
tested (HDT). In the rat developmental toxicity study, maternal 
(systemic) toxicity was 500 mg/kg/day (indicated by body weight 
effects). The NOEL for developmental toxicity was set at equal to or < 
1,000 mg/kg/day (HDT). In the rat two-generation reproduction study, no 
evidence of toxicity was noted in either the adults or the offspring at 
dietary levels at or close to the limit dose of 20,000 ppm (1,705 mg/
kg/day).
    FFDCA section 408 provides that the EPA shall apply an additional 
safety factor of 10 in the case of threshold effects for infants and 
children to account for pre-and post-natal toxicity and the 
completeness of the database unless EPA determines, based on reliable 
data, that a different safety factor would be appropriate. The Agency 
believes that an additional safety factor for infants and children is 
not warranted. A complete set of developmental and reproductive studies 
have been submitted and EPA has found them to be acceptable. The NOEL 
used to calculate the RfD for the general U.S. population is 300 mg/kg 
bw/day derived from the rabbit developmental study. That NOEL is lower 
than the developmental NOEL for the teratology study in rats (3.33x), 
as well as lower than the NOEL for the two-generation reproduction 
study in male and female rats (4.89x to 5.68x). The Agency does not 
believe the effects seen in the above studies are of such concern to 
require an additional safety factor. Accordingly, the Agency believes 
the RfD has an adequate margin of protection for infants and children. 
The percent RfD utilized by imazamox is less than 1% for nursing 
infants (less than 1 year old), and for non-nursing infants and 
children 1 to 6 years old. EPA concluded that there is reasonable 
certainty that no harm will occur to infants and children from 
aggregate exposure to imazamox.

VIII. Other Considerations

    Endocrine effects. No specific tests have been conducted with 
imazamox to determine whether the chemical may have an effect in humans 
that is similar to an effect produced by a naturally occuring estrogen 
or other endocrine effects. However, there were no significant findings 
in other relative toxicity studies, i.e., teratology and multi-
generation reproductive studies, which would suggest that imazamox 
produces endocrine related effects.

IX. Objections and Hearing Requests

    The new FFDCA section 408(g) provides essentially the same process 
for persons to ``object'' to a tolerance regulation issued by EPA under 
the new section 408(e) and (1)(6) as was provided in the old section 
408 and section 409. However, the period for filing objections is 60 
days rather than 30 days. EPA currently has procedural regulations 
which governs 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 August 1, 1997, file written objections to any 
aspect of this regulation and may also request a hearing with the 
Hearing Clerk, at the address given below (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). If a hearing is requested, the objections must include a 
statement of the factual issue(s) on which a hearing is requested, the 
requestor`s contentions on each such issue, and a summary of any 
evidence relied upon by the objector, 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 a 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 issue(s) 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 marked as CBI 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. Information not marked 
confidential may be disclosed publicly by EPA without prior notice.

X. Public Docket

    EPA has established a record for this rulemaking under docket 
number [OPP-300502] (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 1132 of the Public Information and Records 
Integrity Branch, Information Resources and Services Division (7506C), 
Office of Pesticide Programs, Environmental Protection Agency, Crystal 
Mall 2, 1921 Jefferson Davis Highway, Arlington, VA.

[[Page 29673]]

Electronic comments may be sent directly to EPA at:

    [email protected].

    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption.
    The official record for this rulemaking, as well as the public 
version, as described above 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 rulemaking record which 
will also include all comments submitted directly in writing. The 
official rulemaking record is the paper record maintained at the 
address in ``ADDRESSES'' at the beginning of this document.

XI. Regulatory Assessment Requirements

    This final rule establishes a tolerance under section 408 of the 
FFDCA and is in response to a petition received by the Agency 
requesting the establishment of such a tolerance. 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). In addition, 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) (Pub. L. 104-4). Nor does it require any prior consultation as 
specified by Executive Order 12875, entitled Enhancing the 
Intergovernmental Partnership (58 FR 58093, October 28, 1993), or 
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, because tolerances that are established on the basis 
of a petition under section 408(d) of FFDCA, 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. Prior to the recent amendments to the FFDCA, 
however, EPA had treated such actions as subject to the RFA. The 
amendments to the FFDCA clarify that no proposed rule is required for 
such regulatory actions, which makes the RFA inapplicable to these 
actions. Nevertheless, the Agency has 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 (46 FR 24950, May 4, 1981). In accordance with Small Business 
Administration (SBA) policy, this determination will be provided to the 
Chief Counsel for Advocacy of the SBA upon request.

XII. Submission to Congress and the General Accounting Office

    Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business 
Regulatory Enforcement Fairness Act of 1996, the Agency has submitted 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 General Accounting Office prior to publication of this rule in 
today's Federal Register. This 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, Food additive, Pesticides and pests, 
Reporting and recordkeeping requirements.

    Dated: May 22, 1997.

Stephen L. Johnson,

Acting Director, Office of Pesticide Programs.
    Therefore, 40 CFR part 180 is amended as follows:
    1. The authority citation for part 180 continues to read as 
follows:
    Authority: 21 U.S.C. 346a. and 371.


    2. By adding a new Sec. 180.508 to subpart C to read as follows:


Sec. 180.508  Imazamox; tolerances for residues.

    (a) General. Tolerances are being established for residues of the 
of the herbicide imazamox, [2-[4,5-dihydro-4-methyl-4-(1methylethyl)-5-
oxo-1H-imidazol-2-yl]-5-methoxymethyl-3-pyridine-carboxylic acid], (CAS 
No. 114311-32-9) applied as the free acid or ammonium salt, in or on 
following food commodity:

------------------------------------------------------------------------
                                                              Parts per 
                         Commodity                             million  
------------------------------------------------------------------------
Soybeans...................................................          0.1
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d)  Indirect or inadvertent residues. [Reserved]

[FR Doc. 97-14301 Filed 5-28-97; 1:23 pm]
BILLING CODE 6560-50-F