[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]]
opp-docket@epamail.epa.gov. 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:
tompkins.jim@epamail.epa.gov.
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:="">opp-docket@epamail.epa.gov.
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
