[Federal Register Volume 63, Number 30 (Friday, February 13, 1998)]
[Rules and Regulations]
[Pages 7299-7305]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-3750]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300617; FRL-5771-1]
RIN 2070-AB78
Benoxacor; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
benoxacor (4-(dichloroacetyl)-3,4-dihydro-3-methyl-2H-1,4-benzoxazine
at 0.01 part per million (ppm) when used as an inert ingredient
(safener) in pesticide formulations containing metolachlor in or on raw
agricultural commodities for which tolerances have been established for
metolachlor. It also removes time limitations for residues of benoxacor
on the same commodities that expire on February 14, 1998. Novartis Crop
Protection, Incorporated requested this tolerance under the Federal
Food, Drug and Cosmetic Act (FFDCA), as amended by the Food Quality
Protection Act of 1996 (Pub. L. 104-170).
DATES: This regulation is effective February 13, 1998. Objections and
requests for hearings must be received by EPA on or before April 14,
1998.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300617], 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-300617], 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, 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: 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 5.1/6.1
file format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket control
number [OPP-300617]. 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: Kerry B. Leifer, Registration
Division (7505W), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. Office
location, telephone number, and e-mail address: Rm. 4W17, Crystal
Station #1, 2800 Crystal Drive, Arlington, VA, (703) 308-8811, e-mail:
leifer.kerry@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of June 30, 1992 (57
FR 29031), EPA established time-limited tolerances under section 408 of
the FFDCA 21 U.S.C. 346a(d) for residues of benoxacor at 0.01 ppm when
used as an inert ingredient (safener) in pesticide formulations
containing metolachlor in or on raw agricultural commodities for which
tolerances have been established for metolachlor. These time-limited
tolerances expired on December 1, 1996. In the Federal Register of
November 5, 1996 (61 FR 56954) (FRL-5572-8), EPA issued a notice
pursuant to section 408 of FFDCA 21 U.S.C. 346a(e) announcing the
filing of pesticide petition (PP7E3489) for tolerances by Novartis Crop
Protection, Incorporated, P.O. Box 18300, Greensboro, NC 27419. This
notice included a summary of the petition prepared by Novartis, the
petitioner. There were no comments received in response to the notice
of filing.
The petition requested that 40 CFR 180.460 be amended to extend the
time-limited tolerances for residues of benoxacor at 0.01 ppm when used
as an inert ingredient (safener) in pesticide formulations containing
metolachlor in or on raw agricultural commodities for which tolerances
have been established for metolachlor from December 1, 1996, to
December 1, 1998. On February 21, 1997 (62 FR 7941) (FRL-5583-4), EPA
established time-limited tolerances for benoxacor at 0.01 ppm when used
as an inert ingredient (safener) in pesticide formulations containing
metolachlor in or on raw agricultural commodities for which tolerances
have been established for metolachlor with an expiration date of
February 14, 1998.
[[Page 7300]]
In the Federal Register of November 21, 1997 (62 FR 62304) (FRL-
5755-4), EPA issued a notice pursuant to section 408 of FFDCA 21 U.S.C.
346a(e) announcing the filing of pesticide petition (PP7E3489) for
tolerances by Novartis Crop Protection, Incorporated (formerly Ciba
Crop Protection), P.O. Box 18300, Greensboro, NC 27419. This notice
included a summary of the petition prepared by the petitioner. There
were no comments received in response to the notice of filing.
The petition requested that the time limitation for tolerances
established for residues of benoxacor at 0.01 ppm when used as an inert
ingredient (safener) in pesticide formulations containing metolachlor
in or on raw agricultural commodities for which tolerances have been
established for metolachlor be removed based upon the chronic toxicity
and oncogenicity data submitted as a condition of registration.
The basis for the time-limited tolerances that expire February 14,
1998, was given in the February 21, 1997 issue of the Federal Register
(62 FR 7941). These time-limited tolerances were predicated on the
expiration of pesticide product registrations that were made
conditional due to the lack of certain chronic/oncogenicity data. The
rationale for using time-limited tolerances was to encourage pesticide
manufacturers to comply with the conditions of registration in a timely
manner. There is no regulatory requirement to make tolerances time-
limited due to the conditional status of a product under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) as amended. It is
current EPA policy to no longer establish time limitations on
tolerances if none of the conditions of registration have any bearing
on human dietary risk. The current petition action meets that condition
and thus the expiration dates associated with the crop tolerances are
being deleted.
I. Risk Assessment and Statutory Findings
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. . . .''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides based primarily on toxicological studies using
laboratory animals. These studies address many adverse health effects,
including (but not limited to) reproductive effects, developmental
toxicity, toxicity to the nervous system, and carcinogenicity. Second,
EPA examines exposure to the pesticide through the diet (e.g., food and
drinking water) and through exposures that occur as a result of
pesticide use in residential settings.
A. Toxicity
1. Threshold and non-threshold effects. For many animal studies, a
dose response relationship can be determined, which provides a dose
that causes adverse effects (threshold effects) and doses causing no
observed effects (the ``no-observed effect level'' or ``NOEL'').
Once a study has been evaluated and the observed effects have been
determined to be threshold effects, EPA generally divides the NOEL from
the study with the lowest NOEL by an uncertainty factor (usually 100 or
more) to determine the Reference Dose (RfD). The RfD is a level at or
below which daily aggregate exposure over a lifetime will not pose
appreciable risks to human health. An uncertainty factor (sometimes
called a ``safety factor'') of 100 is commonly used since it is assumed
that people may be up to 10 times more sensitive to pesticides than the
test animals, and that one person or subgroup of the population (such
as infants and children) could be up to 10 times more sensitive to a
pesticide than another. In addition, EPA assesses the potential risks
to infants and children based on the weight of the evidence of the
toxicology studies and determines whether an additional uncertainty
factor is warranted. Thus, an aggregate daily exposure to a pesticide
residue at or below the RfD (expressed as 100% or less of the RfD) is
generally considered acceptable by EPA. EPA generally uses the RfD to
evaluate the chronic risks posed by pesticide exposure. For shorter
term risks, EPA calculates a margin of exposure (MOE) by dividing the
estimated human exposure into the NOEL from the appropriate animal
study. Commonly, EPA finds MOEs lower than 100 to be unacceptable. This
100-fold MOE is based on the same rationale as the 100-fold uncertainty
factor.
Lifetime feeding studies in two species of laboratory animals are
conducted to screen pesticides for cancer effects. When evidence of
increased cancer is noted in these studies, the Agency conducts a
weight of the evidence review of all relevant toxicological data
including short-term and mutagenicity studies and structure activity
relationship. Once a pesticide has been classified as a potential human
carcinogen, different types of risk assessments (e.g., linear low dose
extrapolations or MOE calculation based on the appropriate NOEL) will
be carried out based on the nature of the carcinogenic response and the
Agency's knowledge of its mode of action.
2. Differences in toxic effect due to exposure duration. The
toxicological effects of a pesticide can vary with different exposure
durations. EPA considers the entire toxicity data base, and based on
the effects seen for different durations and routes of exposure,
determines which risk assessments should be done to assure that the
public is adequately protected from any pesticide exposure scenario.
Both short and long durations of exposure are always considered.
Typically, risk assessments include ``acute,'' ``short-term,''
``intermediate term,'' and ``chronic'' risks. These assessments are
defined by the Agency as follows.
Acute risk, by the Agency's definition, results from 1-day
consumption of food and water, and reflects toxicity which could be
expressed following a single oral exposure to the pesticide residues.
High end exposure to food and water residues are typically assumed.
Short-term risk results from exposure to the pesticide for a period
of 1-7 days, and therefore overlaps with the acute risk assessment.
Historically, this risk assessment was intended to address primarily
dermal and inhalation exposure which could result, for example, from
residential pesticide applications. However, since enaction of FQPA,
this assessment has been expanded to include both dietary and non-
dietary sources of exposure, and will typically consider exposure from
food, water, and residential uses when reliable data are available. In
this assessment, risks from average food and water exposure, and high-
end residential exposure, are aggregated. High-end exposures from all
three sources are not typically added because
[[Page 7301]]
of the very low probability of this occurring in most cases, and
because the other conservative assumptions built into the assessment
assure adequate protection of public health. However, for cases in
which high-end exposure can reasonably be expected from multiple
sources (e.g. frequent and widespread homeowner use in a specific
geographical area), multiple high-end risks will be aggregated and
presented as part of the comprehensive risk assessment/
characterization. Since the toxicological endpoint considered in this
assessment reflects exposure over a period of at least 7 days, an
additional degree of conservatism is built into the assessment; i.e.,
the risk assessment nominally covers 1-7 days exposure, and the
toxicological endpoint/NOEL is selected to be adequate for at least 7
days of exposure. (Toxicity results at lower levels when the dosing
duration is increased.)
Intermediate-term risk results from exposure for 7 days to several
months. This assessment is handled in a manner similar to the short-
term risk assessment.
Chronic risk assessment describes risk which could result from
several months to a lifetime of exposure. For this assessment, risks
are aggregated considering average exposure from all sources for
representative population subgroups including infants and children.
B. Aggregate Exposure
In examining aggregate exposure, FFDCA section 408 requires that
EPA take into account available and reliable information concerning
exposure from the pesticide residue in the food in question, residues
in other foods for which there are tolerances, residues in groundwater
or surface water that is consumed as drinking water, and other non-
occupational exposures through pesticide use in gardens, lawns, or
buildings (residential and other indoor uses). Dietary exposure to
residues of a pesticide in a food commodity are estimated by
multiplying the average daily consumption of the food forms of that
commodity by the tolerance level or the anticipated pesticide residue
level. The Theoretical Maximum Residue Contribution (TMRC) is an
estimate of the level of residues consumed daily if each food item
contained pesticide residues equal to the tolerance. In evaluating food
exposures, EPA takes into account varying consumption patterns of major
identifiable subgroups of consumers, including infants and children.The
TMRC is a ``worst case'' estimate since it is based on the assumptions
that food contains pesticide residues at the tolerance level and that
100% of the crop is treated by pesticides that have established
tolerances. If the TMRC exceeds the RfD or poses a lifetime cancer risk
that is greater than approximately one in a million, EPA attempts to
derive a more accurate exposure estimate for the pesticide by
evaluating additional types of information (anticipated residue data
and/or percent of crop treated data) which show, generally, that
pesticide residues in most foods when they are eaten are well below
established tolerances.
Percent of crop treated estimates are derived from federal and
private market survey data. Typically, a range of estimates are
supplied and the upper end of this range is assumed for the exposure
assessment. By using this upper end estimate of percent of crop
treated, the Agency is reasonably certain that exposure is not
understated for any significant subpopulation group. Further, regional
consumption information is taken into account through EPA's computer-
based model for evaluating the exposure of significant subpopulations
including several regional groups, to pesticide residues. For this
pesticide, the most highly exposed population subgroup, non-nursing
infants less than one year old, was not regionally based.
II. Aggregate Risk Assessment and Determination of Safety
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 benoxacor
and to make a determination on aggregate exposure, consistent with
section 408(b)(2), for a tolerance for residues of benoxacor when used
as an inert ingredient (safener) in pesticide formulations containing
metolachlor in or on raw agricultural commodities for which tolerances
have been established for metolachlor at 0.01 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 benoxacor are
discussed below.
1. Acute toxicity. A rat acute oral study with an LD50
>5,000 milligram/kilogram (mg/kg), a rabbit acute dermal study with an
LD50 >2,010 mg/kg, a rat inhalation study with an
LC50 >2,000 mg/liter, a primary eye irritation study in the
rabbit showing moderate eye irritation, a primary dermal irritation
study in the rabbit showing benoxacor is not a skin irritant, and a
skin sensitization study which showed benoxacor to be a skin sensitizer
in the Guinea pig. Results of a dermal absorption study show a maximum
of 55.7% of benoxacor is absorbed by the rat following a 24-hour dermal
exposure.
2. Genotoxicity. Benoxacor did not induce point mutations in vitro
at limit (cytotoxic) concentrations in a Salmonella /mammalian
microsome test or show any mutagenic activity in the Chinese hamster
V79 mammalian point mutation test and is neither clastogenic nor
aneugenic in the Chinese hamster at doses up to the limit dose of 5,000
mg/kg. Benoxacor did not induce unscheduled DNA synthesis in isolated
rat hepatocytes at cytotoxic concentrations up to 20 micrograms/ml.
3. Subchronic toxicity--i. Dogs. In a subchronic feeding study in
dogs (5 dogs/sex/dose), benoxacor was administered at doses of 0, 0.25,
1, 5, 50, 150, or 400 milligram/kilograms/day (mg/kg/day) for 90 days.
The NOEL was 5 mg/kg/day and the lowest observed effect level (LOEL) 50
mg/kg/day based on increased liver and gallbladder weights.
ii. Mice. In a subchronic feeding study, CD-1 mice were
administered dietary concentrations of 0, 50, 500, 2,000, and 6,000 ppm
(approximately 0, 7.14, 70.7, 290, and 1,100 mg/kg/day for males and 0,
9.53, 99.8, 382, and 1,470 mg/kg/day for females) of benoxacor for 13
weeks. The systemic toxicity NOEL was 500 ppm (70.7 and 99.8 mg/kg/day
in males and females respectively) and the systemic toxicity LOEL was
2,000 ppm (290 and 382 mg/kg/day in males and females respectively)
based on increased incidence of renal cortex fibrosis and
calcifications in males, and increases in water consumption, platelet
counts, and liver and kidney weights in both males and females.
iii. Rats. In a subchronic feeding study in rats, six groups of 15
male and 15 female Sprague Dawley rats were fed benoxacor at dietary
concentrations of approximately 0, 0.5, 5, 15, 50, or 300 mg/kg/day for
13 weeks. The NOEL was 5 mg/kg/day and the LOEL was 15 mg/kg/day based
on increased incidence of kidney nephrosis.
[[Page 7302]]
4. Dermal toxicity study. In a 21-day dermal toxicity study,
benoxacor was repeatedly applied daily to the shaved skin of 5 male and
5 female New Zealand white rabbits at dose levels of 0, 1, 500, or
1,010 mg/kg for 6/hours/day . The NOEL was >1,010 mg/kg/day.
5. Developmental toxicity study--i. Rabbits. In an oral
developmental toxicity study, rabbits were administered benoxacor at
doses of 0, 0.5, 2.5, 12.5,and 62.5 mg/kg/day. The systemic maternal
NOEL was 12.5 mg/kg/day and the systemic maternal LOEL was 62.5 mg/kg/
day based on decreased consumption values. The developmental toxicity
NOEL was 12.5 mg/kg/day and the developmental toxicity LOEL was 62.5
mg/kg/day based on increased frequency of vertebral anomalies with or
without associated rib anomalies.
ii. Rats. In an oral developmental toxicity study, rats were
administered benoxacor at doses of 0, 1, 100, and 400 mg/kg/day. The
systemic maternal NOEL was 100 mg/kg/day and the systemic maternal LOEL
was 400 mg/kg/day based on increased maternal gross pathology findings,
and decreased body weight gain. The developmental toxicity NOEL was 100
mg/kg/day and the developmental toxicity LOEL was 400 mg/kg/day based
on decreased fetal weight, number of live fetuses, decreased uterine
weight and increased early resorptions, and fetal visceral variations,
malformations, and skeletal variations.
6. Reproductive toxicity study. In a two-generation reproduction
study, Sprague-Dawley rats were fed in the diet with benoxacor at doses
of 0, 10, 50, 100, 500, and 1,000 ppm for two generations. For
parental/systemic toxicity, the NOEL was 50 ppm (3.55 mg/kg/day in the
male and 4.51 mg/kg/day in the females) and the LOEL was 500 ppm (34.84
mg/kg/day in males and 41.21 mg/kg/day in females) based on decreased
body weight and body weight gain in both sexes and both generations.
For reproductive toxicity the NOEL was 50 ppm (3.55 mg/kg/day in the
male and 4.51 mg/kg/day in the female) and the LOEL was 500 ppm (34.84
mg/kg/day in males and 41.21 mg/kg/day in females) based on decreased
pup body weight on lactation day 21 in both generations.
7. Chronic toxicity study. In a 52-week feeding study, benoxacor
was administered orally to male and female beagle dogs (4/sex/group) at
doses of 0, 1, 5, 40, or 80 mg/kg/day. The NOEL was 5 mg/kg/day and the
LOEL was 40 mg/kg/day based upon decreases in mean body weight gain in
males and increases in adjusted liver and kidney weights and increased
lipofuscin deposition in the kidney in both sexes.
8. Carcinogenicity study. In a carcinogenicity study, CD-1 mice
were fed benoxacor (50/sex/group) at dietary levels of 0, 10, 30, 600,
and 1,200 ppm (0, 1.2, 3.7, 75, and 167 mg/kg/day for males and 0, 1.6,
4.7, 93, and 201 mg/kg/day for females) for 18 months. There was
evidence of carcinogenicity at the two highest doses tested.
Statistically (p<0.05) significant="" increases="" of="" squamous="" cell="" papillomas="" and="" combined="" papillomas/carcinomas="" were="" seen="" in="" the="" nonglandular="" stomach="" (forestomach)="" in="" both="" sexes="" at="" the="" highest="" dose="" tested.="" there="" were="" also="" statistically="" significant="" positive="" trends="" for="" carcinomas="" in="" male="" mice="" and="" for="" papillomas="" and="" combined="" papilloma/="" carcinoma="" in="" both="" sexes.="" for="" chronic="" toxicity,="" the="" noel="" was="" 30="" ppm="" (3.7="" mg/kg/day="" and="" 4.7="" mg/kg/day="" in="" males="" and="" females,="" respectively)="" and="" the="" systemic="" loel="" was="" 600="" ppm="" (75="" mg/kg/day="" and="" 93="" mg/kg/day="" in="" males="" and="" females,="" respectively)="" based="" on="" increased="" liver/body="" weight="" ratios="" in="" both="" sexes.="" the="" noel="" for="" mouse="" forestomach="" tumors="" was="" 3.7="" mg/kg/day="" in="" males="" and="" 4.7="" mg/kg/day="" in="" females="" with="" tumors="" occurring="" at="" 75="" and="" 93="" mg/kg/day="" in="" males="" and="" females.="" dosing="" was="" considered="" adequate="" to="" assess="" the="" carcinogenic="" potential="" of="" benoxacor="" based="" on="" body="" weight="" reduction="" in="" males,="" treatment-related="" increased="" liver/body="" weight="" ratios="" in="" both="" sexes,="" and="" other="" treatment-related="" increased="" incidences="" of="" tumor="" and="" nontumor="" findings="" in="" the="" forestomach.="" 9.="" chronic/oncogenicity="" study.="" in="" a="" combined="" chronic/oncogenicity="" study,="" crl:cd="" br="" rats="" (70="" ex/group)="" were="" fed="" benoxacor="" dosed="" at="" dietary="" levels="" of="" 0,="" 10,="" 50,="" 500,="" and="" 1,000="" ppm="" (0,="" 0.4,="" 2.0,="" 20.6,="" and="" 41="" mg/kg/day="" for="" males="" and="" 0,="" 0.6,="" 2.8,="" 28.2,="" and="" 59="" mg/kg/day="" for="" females)="" for="" two="" years.="" statistically="" significant=""><0.01) increasing="" trends="" were="" seen="" in="" male="" rats="" for="" forestomach="" squamous="" cell="" papillomas="" and="" papillomas="" and/or="" carcinomas="" combined.="" there="" was="" also="" a="" statistically="" significant=""><0.05) increasing="" trend="" for="" forestomach="" squamous="" cell="" carcinomas="" in="" male="" rats.="" there="" were="" significant="" differences="" in="" the="" pair-wise="" comparisons="" of="" the="" male="" high-dose="" group="" with="" the="" controls="" for="" forestomach="" squamous="" cell="" papillomas=""><0.05) and="" for="" papillomas="" and/or="" carcinomas="" combined=""><0.01). statistically="" significant=""><0.01) increasing="" trends,="" and="" differences="" in="" the="" pair-="" wise="" comparisons="" of="" the="" high-dose="" group="" with="" the="" controls,="" were="" seen="" in="" female="" rats="" for="" forestomach="" squamous="" cell="" papillomas="" and="" papillomas="" and/or="" carcinomas="" combined.="" for="" chronic="" toxicity,="" the="" noel="" was="" 10="" ppm="" (0.4="" mg/kg/day="" and="" 0.6="" mg/kg/day="" in="" males="" and="" females,="" respectively)="" and="" the="" systemic="" loel="" is="" 50="" ppm="" (2.0="" mg/kg/day="" in="" males)="" based="" on="" centrolobular="" hepatic="" enlargements="" with="" or="" without="" hepatocytic="" vacuolation="" in="" male="" rat="" livers.="" at="" a="" dose="" level="" of="" 2.6="" mg/kg/day,="" hyperkeratosis="" of="" the="" forestomach="" in="" females="" was="" observed.="" the="" noel="" for="" rat="" forestomach="" tumors="" was="" 20.6="" mg/kg/day="" in="" males="" and="" 28.2="" in="" females="" with="" tumors="" occurring="" at="" 41="" and="" 59="" mg/kg/day="" in="" males="" and="" females.="" b.="" toxicological="" endpoints="" 1.="" acute="" toxicity.="" an="" acute="" dietary="" risk="" assessment="" for="" the="" general="" population,="" including="" infants="" and="" children,="" is="" not="" required="" because="" no="" treatment-related="" effects="" attributable="" to="" a="" single="" exposure="" (dose)="" were="" seen="" in="" oral="" studies="" conducted="" with="" benoxacor.="" 2.="" short-="" and="" intermediate-term="" toxicity.="" a="" short-="" and="" intermediate-term="" risk="" assessment="" is="" not="" required="" for="" benoxacor.="" there="" was="" no="" systemic="" toxicity="" at="" 1,010="" mg/kg/day="" (highest="" dose="" tested)="" in="" a="" 21-day="" dermal="" toxicity="" study="" in="" rabbits.="" 3.="" chronic="" toxicity.="" epa="" has="" established="" the="" rfd="" for="" benoxacor="" at="" 0.004="" mg/kg/day.="" this="" rfd="" is="" based="" on="" a="" 2-year="" feeding="" study="" in="" rats="" with="" a="" noel="" of="" 0.4="" mg/kg/day.="" an="" uncertainty="" factor="" of="" 100="" was="" used="" in="" calculating="" the="" rfd="" to="" account="" for="" interspecies="" extrapolation="" and="" intra-species="" variability.="" 4.="" carcinogenicity.="" epa's="" health="" effects="" division="" carcinogenicity="" peer="" review="" committee="" (cprc)="" has="" determined="" that,="" in="" accordance="" with="" the="" epa="" proposed="" guidelines="" for="" carcinogenic="" risk="" assessment="" (april="" 23,="" 1996),="" benoxacor's="" carcinogenic="" potential="" be="" characterized="" as="" ``cannot="" be="" determined,="" but="" suggestive''="" based="" on="" increases="" in="" forestomach="" tumors="" in="" both="" sexes="" of="" mice="" and="" rats.="" the="" consensus="" of="" the="" cprc="" was="" that="" these="" tumors="" have="" little="" or="" no="" relevance="" to="" humans.="" for="" cancer="" risk="" assessment="" purposes,="" the="" cprc="" recommended="" using="" a="" threshold="" (moe)="" approach="" based="" on="" the="" most="" sensitive="" precursor="" forestomach="" lesions.="" it="" was="" further="" recommended="" that="" the="" noel="" for="" rat="" forestomach="" lesions="" of="" 0.4="" mg/kg/day="" be="" used="" as="" the="" point="" of="" departure="" for="" moe="" calculations.="" c.="" exposures="" and="" risks="" 1.="" from="" food="" and="" feed="" uses.="" tolerances="" have="" been="" established="" (40="" cfr="" 180.460)="" for="" the="" residues="" of="" benoxacor="" in="" or="" on="" a="" variety="" of="" raw="" agricultural="" commodities.="" risk="" assessments="" were="" conducted="" by="" epa="" to="" [[page="" 7303]]="" assess="" dietary="" exposures="" and="" risks="" from="" benoxacor="" 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="" one="" day="" or="" single="" exposure.="" since="" there="" are="" no="" acute="" toxicological="" concerns="" for="" benoxacor,="" an="" acute="" dietary="" risk="" assessment="" was="" not="" required.="" ii.="" chronic="" exposure="" and="" risk.="" for="" the="" purpose="" of="" assessing="" chronic="" dietary="" exposure="" from="" benoxacor,="" epa="" considered="" the="" proposed="" benoxacor="" tolerance="" of="" 0.01="" ppm="" and="" the="" raw="" agricultural="" commodities="" for="" which="" tolerances="" have="" been="" established="" for="" metolachlor.="" there="" are="" no="" other="" established="" u.s.="" tolerances="" for="" benoxacor,="" and="" there="" are="" no="" other="" registered="" uses="" for="" benoxacor="" on="" food="" or="" feed="" crops="" in="" the="" united="" states.="" in="" conducting="" this="" exposure="" assessment,="" epa="" assumed="" tolerance="" level="" residues="" and="" 100%="" crop="" treated,="" resulting="" in="" a="" large="" overestimation="" of="" dietary="" exposure="" and="" protective="" of="" any="" chronic="" dietary="" exposure="" scenario.="" further,="" regional="" consumption="" information="" is="" taken="" into="" account="" through="" epa's="" computer-based="" model="" for="" evaluating="" the="" exposure="" of="" significant="" subpopulations="" including="" several="" regional="" groups.="" review="" of="" this="" regional="" data="" allows="" the="" agency="" to="" be="" reasonably="" certain="" that="" no="" regional="" population="" is="" exposed="" to="" residue="" levels="" higher="" than="" those="" estimated="" by="" the="" agency.="" based="" on="" the="" chronic="" dietary="" exposure="" tmrc's="" of="" 0.000205="" mg/kg/day="" for="" the="" u.s.="" population="" and="" 0.000828="" mg/kg/day="" for="" the="" most="" highly="" exposed="" population="" subgroup="" (non-nursing="" infants="" less="" than="" one="" year="" old),="" this="" chronic="" dietary="" risk="" assessment="" resulted="" in="" the="" use="" of="" 5.13%="" of="" the="" rfd="" for="" the="" u.s.="" population="" and="" 20.7%="" of="" the="" rfd="" for="" the="" most="" highly="" exposed="" population="" subgroup.="" a="" cancer="" dietary="" moe="" was="" calculated="" to="" be="" 1,950.="" 2.="" from="" drinking="" water.="" for="" the="" purposes="" of="" assessing="" chronic="" exposure="" in="" drinking="" water,="" epa="" has="" considered="" the="" registered="" uses="" and="" the="" available="" data="" on="" persistence="" and="" mobility="" for="" benoxacor.="" the="" agency="" has="" determined="" through="" a="" qualitative="" risk="" assessment="" that="" the="" physical="" and="" chemical="" characteristics="" of="" benoxacor="" are="" such="" that="" it="" is="" not="" expected="" to="" impact="" water="" resources.="" while="" benoxacor="" is="" mobile,="" it="" is="" not="" persistent="" (half-life="" in="" soil="" of="" 49="" days="" under="" aerobic="" conditions="" and="" 70="" days="" anaerobically).="" in="" light="" of="" these="" findings,="" epa="" believes="" that="" benoxacor's="" use="" will="" not="" impact="" ground="" water="" or="" surface="" water="" resources,="" and="" therefore,="" is="" not="" expected="" to="" lead="" to="" exposure="" to="" humans="" through="" drinking="" water.="" if="" new="" uses="" are="" added="" in="" the="" future,="" opp="" will="" reassess="" the="" potential="" impacts="" of="" benoxacor="" on="" drinking="" water="" as="" a="" part="" of="" the="" aggregate="" risk="" assessment="" process.="" 3.="" from="" non-dietary="" exposure.="" all="" registered="" metolachlor="" products="" to="" which="" benoxacor="" is="" added="" as="" a="" safener="" are="" commercial="" agricultural="" products="" not="" registered="" for="" residential="" use.="" the="" potential="" for="" non-="" occupational="" exposure="" to="" benoxacor="" by="" the="" general="" population="" is="" therefore="" unlikely="" except="" for="" the="" potential="" residues="" in="" food="" crops="" discussed="" above.="" 4.="" 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="" turn="" out="" to="" be="" helpful="" in="" eventually="" determining="" whether="" a="" pesticide="" shares="" a="" common="" mechanism="" of="" toxicity="" with="" any="" other="" substances,="" epa="" does="" not="" at="" this="" time="" have="" the="" methodologies="" to="" resolve="" the="" complex="" scientific="" issues="" concerning="" common="" mechanism="" of="" toxicity="" in="" a="" meaningful="" way.="" epa="" has="" begun="" a="" pilot="" process="" to="" study="" this="" issue="" further="" through="" the="" 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="" mechanism="" issues="" can="" be="" resolved.="" these="" pesticides="" include="" pesticides="" that="" are="" toxicologically="" dissimilar="" to="" existing="" chemical="" substances="" (in="" which="" case="" 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="" benoxacor="" 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,="" benoxacor="" 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="" benoxacor="" has="" a="" common="" mechanism="" of="" toxicity="" with="" other="" substances.="" d.="" aggregate="" risks="" and="" determination="" of="" safety="" for="" u.s.="" population="" 1.="" acute="" risk.="" since="" there="" are="" no="" acute="" toxicological="" concerns="" for="" benoxacor,="" epa="" has="" no="" cause="" for="" concern="" for="" acute="" aggregate="" exposure.="" 2.="" chronic="" risk.="" using="" the="" tmrc="" exposure="" assumptions="" described="" above,="" epa="" has="" concluded="" that="" aggregate="" chronic="" exposure="" to="" benoxacor="" from="" food="" and="" water="" will="" utilize="" 5.13%="" of="" the="" rfd="" for="" the="" u.s.="" population.="" the="" major="" identifiable="" subgroup="" with="" the="" highest="" aggregate="" exposure="" is="" non-nursing="" infants="" less="" than="" one="" year="" old="" (utilizing="" 20.7%="" of="" the="" rfd).="" 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.="" epa="" does="" not="" expect="" the="" aggregate="" exposure="" to="" exceed="" 100%="" of="" the="" rfd.="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" from="" aggregate="" exposure="" to="" benoxacor="" residues.="" e.="" aggregate="" cancer="" risk="" for="" u.s.="" population="" the="" carcinogenic="" risk="" from="" food="" uses="" of="" benoxacor="" for="" the="" general="" u.s.="" population="" was="" calculated="" by="" comparing="" the="" dietary="" exposure="" from="" benoxacor="" to="" the="" noel="" identified="" for="" use="" with="" the="" cancer="" risk="" assessment.="" based="" on="" the="" noel="" selected="" by="" the="" cprc="" for="" cancer="" risk="" characterization="" of="" 0.4="" mg/kg/day,="" the="" cancer="" risk="" was="" estimated="" to="" result="" in="" a="" moe="" of="" 1,950="" contributed="" through="" all="" the="" published,="" pending="" and="" new="" uses="" for="" benoxacor.="" based="" upon="" the="" extreme="" conservatism="" of="" the="" dietary="" exposure="" estimates="" and="" the="" fact="" that="" tumors="" were="" [[page="" 7304]]="" observed="" only="" at="" dose="" levels="" far="" in="" excess="" of="" the="" selected="" noel,="" this="" moe="" is="" at="" a="" level="" which="" the="" agency="" does="" not="" consider="" raising="" a="" concern="" for="" excess="" lifetime="" cancer.="" f.="" 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="" benoxacor,="" 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="" 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="" post-natal="" toxicity="" and="" the="" completeness="" of="" the="" database="" 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="" moe="" analysis="" or="" through="" using="" uncertainty="" (safety)="" factors="" in="" calculating="" a="" dose="" level="" that="" poses="" no="" appreciable="" risk="" to="" humans.="" in="" either="" case,="" epa="" generally="" defines="" the="" level="" of="" appreciable="" risk="" as="" exposure="" that="" is="" greater="" than="" 1/100="" of="" the="" noel="" in="" the="" animal="" study="" appropriate="" to="" the="" particular="" risk="" assessment.="" this="" 100-fold="" uncertainty="" (safety)="" factor/moe="" (safety)="" is="" designed="" to="" account="" for="" inter-species="" extrapolation="" and="" intra-species="" variability.="" epa="" believes="" that="" reliable="" data="" support="" using="" the="" 100-fold="" uncertainty="" factor="" rather="" than="" the="" 1,000-fold="" margin/factor,="" when="" epa="" has="" a="" complete="" data="" base="" under="" existing="" guidelines="" and="" when="" the="" severity="" of="" the="" effect="" in="" infants="" or="" children,="" the="" potency="" or="" unusual="" toxic="" properties="" of="" a="" compound,="" or="" the="" quality="" of="" the="" exposure="" data="" do="" not="" raise="" concerns="" regarding="" the="" adequacy="" of="" the="" standard="" margin/factor.="" ii.="" developmental="" toxicity="" studies.="" see="" toxicological="" profile="" in="" unit="" ii.a.="" of="" this="" preamble.="" iii.="" reproductive="" toxicity="" study.="" see="" toxicological="" profile="" in="" unit="" ii.a.="" of="" this="" preamble.="" iv.="" pre-="" and="" post-natal="" sensitivity.="" there="" is="" no="" evidence="" of="" increased="" sensitivity="" to="" young="" rats="" or="" rabbits="" following="" pre-="" or="" post-="" natal="" exposure="" to="" benoxacor.="" v.="" conclusion.="" the="" toxicological="" data="" base="" for="" evaluating="" pre-="" and="" post-natal="" toxicity="" for="" benoxacor="" is="" complete="" with="" respect="" to="" current="" data="" requirements.="" because="" both="" developmental="" and="" reproductive="" effects="" occurred="" in="" the="" presence="" of="" parental="" (systemic)="" toxicity,="" these="" data="" do="" not="" suggest="" an="" increased="" pre-="" or="" post-natal="" sensitivity="" of="" children="" and="" infants="" to="" benoxacor="" exposure.="" based="" on="" the="" above,="" epa="" concludes="" that="" reliable="" data="" support="" use="" of="" a="" 100-fold="" moe/uncertainty="" factor,="" rather="" than="" the="" standard="" 1,000-fold="" margin/factor="" to="" protect="" infants="" and="" children.="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" to="" infants="" and="" children="" from="" aggregate="" exposure="" to="" benoxacor="" residues.="" 2.="" acute="" risk.="" since="" there="" are="" no="" acute="" toxicological="" concerns="" for="" benoxacor,="" epa="" has="" no="" cause="" for="" concern="" for="" acute="" aggregate="" exposure.="" 3.="" chronic="" risk.="" using="" the="" conservative="" exposure="" assumptions="" described="" above,="" epa="" has="" concluded="" that="" aggregate="" exposure="" to="" benoxacor="" from="" food="" will="" range="" from="" 3.69%="" of="" the="" rfd="" for="" females="" 13+="" years,="" to="" 20.7%="" of="" the="" rfd="" for="" non-nursing="" infants="" less="" than="" one="" year="" old.="" 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.="" epa="" does="" not="" expect="" the="" aggregate="" exposure="" to="" exceed="" 100%="" of="" the="" rfd.="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" to="" infants="" and="" children="" from="" aggregate="" exposure="" to="" benoxacor="" residues.="" 4.="" cancer="" risk.="" carcinogenic="" risk="" to="" infants="" and="" children="" from="" food="" uses="" of="" benoxacor="" is="" addressed="" under="" aggregate="" cancer="" risk="" for="" u.s.="" population="" under="" unit="" ii.e.="" of="" this="" preamble.="" iii.="" other="" considerations="" a.="" metabolism="" in="" plants="" and="" animals="" the="" metabolism="" of="" benoxacor="" in="" plants="" and="" animals="" is="" adequately="" understood="" for="" purposes="" of="" these="" tolerances.="" b.="" analytical="" enforcement="" methodology="" adequate="" enforcement="" methodology,="" gc/npd,="" is="" available="" to="" enforce="" the="" tolerance="" expression.="" an="" analytical="" methodology="" for="" the="" determination="" of="" benoxacor="" and="" its="" metabolites="" in="" plant="" and="" animal="" commodities="" (ciba="" analytical="" method="" ag536(c))="" is="" available="" from:="" calvin="" furlow,="" 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.="" office="" location="" and="" telephone="" number:="" rm.="" 119ff,="" cm#2,="" 1921="" jefferson="" davis="" hwy.,="" arlington,="" va="" 22202,="" (703)="" 305-5229.="" c.="" magnitude="" of="" residues="" the="" magnitude="" of="" the="" residue="" in="" plants="" is="" adequately="" understood="" for="" the="" purposes="" of="" these="" tolerances.="" d.="" international="" residue="" limits="" no="" codex="" maximum="" residue="" levels="" have="" been="" established="" for="" residues="" of="" benoxacor="" on="" commodities="" for="" which="" a="" tolerance="" for="" metolachlor="" exist.="" iv.="" conclusion="" therefore,="" the="" tolerances="" are="" established="" for="" benoxacor="" (4-="" (dichloroacetyl)-3,4-dihydro-3-methyl-2h-1,4-benzoxazine)="" at="" 0.01="" ppm="" when="" used="" as="" an="" inert="" ingredient="" (safener)="" in="" pesticide="" formulations="" containing="" metolachlor="" in="" or="" on="" raw="" agricultural="" commodities="" for="" which="" tolerances="" have="" been="" established="" for="" metolachlor.="" v.="" 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="" new="" section="" 408(e)="" and="" (l)(6)="" 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="" april="" 14,="" 1998,="" 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="" above="" (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="" issues="" on="" which="" a="" hearing="" is="" requested,="" the="" requestor's="" [[page="" 7305]]="" 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.="" information="" not="" marked="" confidential="" may="" be="" disclosed="" publicly="" by="" epa="" without="" prior="" notice.="" vi.="" public="" record="" and="" electronic="" submissions="" epa="" has="" established="" a="" record="" for="" this="" rulemaking="" under="" docket="" control="" number="" [opp-300617]="" (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.="" 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
Virginia address in ``ADDRESSES'' at the beginning of this document.
VII. Regulatory Assessment Requirements
This final rule establishes tolerances under FFDCA section 408(d)
in response to a petition submitted to the Agency. 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) (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, since these tolerances and exemptions that are
established on the basis of a petition under FFDCA section 408(d), such
as the tolerances 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 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. 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.
VIII. 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 to 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.
Dated: February 10, 1998.
Peter Caulkins,
Acting 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 and 371.
2. Section 180.460 is revised to read as follows:
Sec. 180.460 Benoxacor; tolerances for residues.
(a) General . Tolerances are established for residues of the inert
ingredient (safener) benoxacor (4-(dichloroacetyl)-3,4-dihydro-3-
methyl-2H-1,4-benzoxazine) at 0.01 ppm when used in pesticide
formulations containing metolachlor in or on raw agricultural
commodities for which tolerances have been established for metolachlor.
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 98-3750 Filed 2-12-98; 8:45 am]
BILLING CODE 6560-50-F
