[Federal Register Volume 63, Number 115 (Tuesday, June 16, 1998)]
[Rules and Regulations]
[Pages 32753-32760]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-15746]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 180, 185 and 186
[OPP-300663; FRL-5793-5]
RIN 2070-AB78
Quizalofop-p ethyl ester; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for combined residues
of quizalofop-p ethyl ester [ethyl (R)-(2-[4-((6-chloroquinoxalin-2-
yl)oxy)phenoxyl] propanoate), and its acid metabolite quizalofop-p
[(R)-(2-[4-((6-chloroquinoxalin-2-yl)oxy)phenoxyl]propionate) and the S
enantiomers of the ester and the acid, all expressed as quizalofop-p
ethyl ester in or on canola seed, canola meal, peppermint tops and
spearmint tops. DuPont Agricultural Products requested the tolerances
for canola and the Interregional Research Project Number 4 (IR-4)
requested the tolerances for peppermint and spearmint. These tolerances
were requested under the Federal Food, Drug, and Cosmetic Act, as
amended by the Food Quality Protection Act of 1996 (Pub. L. 104-170).
DATES: This regulation is effective June 16, 1998. Objections and
requests for hearings must be received by EPA on or before August 17,
1998.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300663], 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-300663], 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-300663]. 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: Sidney Jackson, 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: Crystal Mall #2, 1921
Jefferson Davis Hwy., Arlington, VA, (703) 305-7610; e-mail:
jackson.sidney@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register published on October
29, 1997 (62 FR 56176 (mint)) (FRL-5749-7) and December 17, 1997, 62 FR
66080 (canola)) (FRL-5758-3), EPA, issued notices pursuant to section
408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C.
346a(e) announcing the filing of pesticide petitions (PP) 6E4652 and
5F4545 for tolerances by the IR-4 and DuPont Agricultural Products,
Wilmington, Delaware. These notices included a summary of the petitions
prepared by DuPont Agricultural Products, Wilmington, Delaware, the
registrant. There were no comments received in response to these
notices of filing.
The petitions requested that 40 CFR 180.441 be amended by
establishing tolerances for combined residues of the herbicide
quizalofop-p ethyl ester [ethyl (R)-(2-[4-((6-chloroquinoxalin-2-
yl)oxy)phenoxyl] propanoate), and its acid metabolite quizalofop-p
[(R)-(2-[4-((6-chloroquinoxalin-2-yl)oxy)phenoxyl] propionate) and the
S enantiomers of the ester and the acid, all expressed as quizalofop-p
ethyl ester, in or on canola seed at 1.0 part per million (ppm), canola
meal at 1.5 ppm, and peppermint tops and spearmint tops at 2.0 ppm. .
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
[[Page 32754]]
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 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
[[Page 32755]]
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 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
quizalofop-p ethyl ester and to make a determination on aggregate
exposure, consistent with section 408(b)(2), for a tolerance for
combined residues of quizalofop-p-ethyl ester on canola seed at 1.0
ppm, canola meal at 1.5 ppm, and peppermint tops and spearmint tops at
2.0 ppm. EPA's assessment of the dietary exposures and risks associated
with establishing the tolerances 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 quizalofop-p ethyl
ester are discussed below.
1. Acute toxicity. Acute toxicology studies include: acute oral
toxicity (lethal dose) (LD50s) at 1,480 and 1,670 milligrams
(mg)/kilogram (kg) for female and male rats, respectively); eye
irritation (not an eye irritant); dermal toxicity (LD50 >
5,000 mg/kg in rats); inhalation toxicity (lethal concentration)
(LC50 = 5.8 mg/liter(L)in rats); and dermal irritation (not
a dermal sensitizer).
2. Genotoxicity. Quizalofop ethyl was negative in the following
genotoxicity tests: bacterial gene mutation assays (Ames assay);
chromosomal aberration assays in Chinese hamster ovary (CHO) cells;
unscheduled DNA synthesis; and combinant assays and reversion assay in
Salmonella.
3. Reproductive and developmental toxicity. A developmental
toxicity study in rats administered dosage levels of 0, 30, 100, and
300 mg/kg/day. The maternal toxicity NOEL was 30 mg/kg/day and a
developmental toxicity NOEL was greater than 300 mg/kg/day, highest
dose tested (HDT). The maternal NOEL was based on reduced food
consumption and body weight, and increased liver weights. There were no
developmental effects observed.
A developmental toxicity study in rabbits administered dosage
levels of 0, 7, 20, and 60 mg/kg/day with no developmental effects
noted at 60 mg/kg/day (HDT). The maternal toxicity NOEL was established
at 20 mg/kg/day based on decreased food consumption and body weight at
60/mg/kg/day (HDT).
In a two-generation reproductive toxicity study, Sprague-Dawley
rats were fed diets containing quizalofop-p-ethyl at 0, 25, 100, or 400
ppm (0, 1.25, 5.0, or 20 mg/kg/day respectively). The parental NOEL was
100 ppm (5.0 mg/kg/day) and the lowest-observed effect level (LOEL) was
400 ppm (20 mg/kg/day), based on decreased body weights in males of
both generations. The developmental NOEL for effects on the offspring
was 25 ppm (1.25 mg/kg/day) and the offspring developmental LOEL was
100 ppm (5.0 mg/kg/day), based on increased incidence of eosinophilic
changes in the livers of F2 weanling. In addition, at 400 ppm (20 mg/
kg/day), reductions in litter size, survival, body weights, and spleen
weight were seen in offspring.
4. Subchronic toxicity. A 90-day study was conducted in rats fed
diets containing 0, 40, 128, 1,280 ppm (or approximately 0, 2, 6.4 and
64 mg/kg/day, respectively). The NOEL was 2 mg/kg/day. This was based
on increased liver weights at 6.4 mg/kg.
A 90-day feeding study in mice was conducted with diets that
contained 0, 100, 316 or 1,000 ppm (or approximately 0, 15, 47.4, and
150 mg/kg/day, respectively). The NOEL was < 15="" mg/kg/day="" (lowest="" dose="" tested)="" based="" on="" increased="" liver="" weights="" and="" reversible="" histopathological="" effects="" in="" the="" liver="" at="" the="" lowest="" dose="" tested.="" 5.="" chronic="" toxicity.="" an="" 18-month="" carcinogenicity="" study="" was="" conducted="" in="" cd-1="" mice="" fed="" diets="" containing="" 0,="" 2,="" 10,="" 80="" or="" 320="" ppm="" (or="" approximately="" 0,="" 0.3,="" 1.5,="" 12,="" and="" 48="" mg/kg/day,="" respectively).="" there="" were="" no="" carcinogenic="" effects="" observed="" under="" the="" conditions="" of="" the="" study="" at="" levels="" up="" to="" and="" including="" 12="" mg/kg/day.="" a="" marginal="" increase="" in="" the="" incidence="" of="" hepatocellular="" tumors="" was="" observed="" at="" 48="" mg/kg/day,="" the="" highest="" dose="" tested="" (hdt)="" which="" exceeded="" the="" maximum="" tolerated="" dose="" (mtd).="" a="" 2-year="" chronic="" toxicity/carcinogenicity="" study="" was="" conducted="" in="" rats="" fed="" diets="" containing="" 0,="" 25,="" 100="" or="" 400="" ppm="" (or="" 0,="" 0.9,="" 3.7,="" and="" 15.5="" mg/kg/day="" for="" males="" and="" 0,="" 1.1,="" 4.6,="" and="" 18.6="" mg/kg/day="" for="" females,="" respectively).="" there="" were="" no="" carcinogenic="" effects="" observed="" under="" the="" conditions="" of="" the="" study="" at="" levels="" up="" to="" and="" including="" 18.6="" g/="" kg/day="" (hdt).="" the="" systemic="" noel="" was="" 0.9="" mg/kg/day="" based="" on="" altered="" red="" cell="" parameters="" and="" slight/minimal="" centrilobuler="" enlargement="" of="" the="" liver="" at="" 3.7="" mg/kg/day.="" a="" 1-year="" feeding="" study="" was="" conducted="" in="" dogs="" fed="" diets="" containing="" 0,="" 25,="" 100="" or="" 400="" ppm="" (or="" approximately="" 0,="" 0.625,="" 2.5,="" or="" 10="" mg/kg/day,="" respectively).="" the="" noel="" was="" greater="" than="" 10="" mg/kg/day,="" the="" lowest="" dose="" tested="" (ldt).="" b.="" toxicological="" endpoints="" 1.="" acute="" toxicity.="" there="" were="" no="" effects="" observed="" in="" oral="" toxicity="" studies="" that="" could="" be="" attributable="" to="" a="" single="" dose="" (exposure).="" therefore,="" a="" dose="" and="" an="" endpoint="" have="" not="" been="" identified="" for="" this="" risk="" assessment.="" this="" risk="" assessment="" is="" not="" required.="" .="" 2.="" short="" -="" and="" intermediate="" -="" term="" toxicity.="" in="" a="" 21-day="" dermal="" toxicity="" study,="" new="" zealand="" white="" rabbits="" (5/sex/dose)="" received="" 15="" repeated="" dermal="" applications="" (aqueous="" paste)="" of="" quizalofop-p-ethyl="" ester="" at="" doses="" of="" 0,="" 125,="" 600="" or="" 2,000="" mg/kg/day,="" 6="" hours/day,="" 5="" days/="" week="" over="" a="" 21-day="" period.="" there="" was="" no="" dermal="" or="" systemic="" toxicity.="" the="" noel="" was="" 2,000="" mg/kg/day.="" in="" addition,="" no="" maternal="" or="" developmental="" toxicity="" was="" observed="" following="" in="" utero="" exposures="" in="" rats="" and="" rabbits.="" these="" risk="" assessments="" are="" not="" required.="" 3.="" chronic="" toxicity.="" epa="" has="" established="" the="" rfd="" for="" quizalofop-p="" ethyl="" ester="" at="" 0.009="" mg/kg/day.="" this="" rfd="" is="" based="" on="" the="" 2-year="" feeding="" study="" in="" rats.="" groups="" of="" male="" and="" female="" sprague-dawley="" rats="" (50/sex/="" dose)="" were="" fed="" diets="" containing="" quizalofop-p-ethyl="" ester="" at="" 0,="" 25,="" 100="" or="" 400="" ppm="" for="" 104="" weeks.="" for="" chronic="" toxicity,="" the="" noel="" [[page="" 32756]]="" was="" 25="" ppm="" (0.9="" mg/kg/day)="" and="" the="" loel="" was="" 100="" ppm="" based="" on="" the="" occurrence="" of="" generalized="" hepatocyte="" enlargement="" in="" female="" rats="" and="" red="" blood="" cell="" destruction="" in="" males.="" in="" addition,="" there="" was="" generalized="" hepatocyte="" enlargement="" and="" red="" blood="" cell="" destruction="" in="" both="" sexes="" at="" 400="" ppm.="" rfd="0.9" mg/kg/day="" (noel)="0.009" mg/kg/day="" 100="" (uf).="" 4.="" carcinogenicity.="" opp's="" health="" effects="" division,="" carcinogenicity="" peer="" review="" committee="" (cprc)="" has="" evaluated="" the="" rat="" and="" mouse="" cancer="" studies="" for="" quizalofop-p="" ethyl="" ester="" along="" with="" other="" relevant="" short-="" term="" toxicity,="" mutagenicity="" studies,="" and="" structure-activity="" relationships.="" the="" cprc="" has="" classified="" quizalofop-p="" ethyl="" as="" a="" group="" d="" carcinogen="" (not="" classifiable="" as="" to="" human="" cancer="" potential).="" the="" group="" d="" classification="" is="" based="" on="" an="" approximate="" doubling="" in="" the="" incidence="" of="" mice="" liver="" tumors="" between="" controls="" and="" the="" high="" dose.="" this="" finding="" was="" not="" considered="" strong="" enough="" to="" warrant="" the="" classification="" of="" a="" category="" c="" (possible="" human="" carcinogen):="" the="" increase="" was="" of="" marginal="" statistical="" significance,="" occurred="" at="" high="" dose="" which="" exceeded="" the="" mtd,="" and="" occurred="" in="" a="" study="" in="" which="" the="" concurrent="" control="" for="" liver="" tumors="" was="" somewhat="" low="" as="" compared="" to="" the="" historical="" controls,="" while="" the="" high="" dose="" control="" group="" was="" at="" the="" upper="" end="" of="" previous="" historical="" control="" groups.="" no="" new="" cancer="" studies="" are="" required="" for="" quizalofop-p="" ethyl="" ester="" at="" this="" time.="" c.="" exposures="" and="" risks="" 1.="" from="" food="" and="" feed="" uses.="" tolerances="" have="" been="" established="" (40="" cfr="" 180.441)="" for="" the="" combined="" residues="" of="" quizalofop-p="" ethyl="" ester="" and="" its="" acid="" metabolite="" quizalofop-p="" and="" the="" s="" enantiomers="" of="" the="" ester="" and="" the="" acid,="" all="" expressed="" as="" quizalofop-p="" ethyl="" ester="" in="" or="" on="" a="" variety="" of="" raw="" agricultural="" commodities.="" tolerances="" are="" established="" for="" cottonseed="" at="" 0.1="" ppm,="" lentils="" at="" 0.05="" ppm.="" time-limited="" tolerances="" are="" established="" for="" sugarbeet="" roots="" at="" 0.1="" ppm,="" sugarbeet="" tops="" at="" 0.5="" ppm,="" legume="" vegetables="" crop="" group="" at="" 0.25="" ppm,="" and="" foliage="" of="" legume="" vegetables="" (except="" soybeans)="" at="" 3.0="" ppm.="" risk="" assessments="" were="" conducted="" by="" epa="" to="" assess="" dietary="" exposures="" and="" risks="" from="" quizalofop-="" p="" ethyl="" ester="" 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.="" there="" are="" no="" acute="" toxicological="" concerns="" for="" quizalofop-p="" ethyl="" ester.="" ii.="" chronic="" exposure="" and="" risk.="" in="" conducting="" this="" chronic="" dietary="" risk="" assessment,="" epa="" has="" made="" very="" conservative="" assumptions="" --="" 100%="" of="" mint,="" canola,="" and="" all="" other="" commodities="" having="" quizalofop-p-ethyl="" ester="" tolerances="" will="" contain="" the="" regulable="" residues="" and="" those="" residues="" will="" be="" at="" the="" level="" of="" the="" tolerance.="" thus,="" in="" making="" a="" safety="" determination="" for="" these="" tolerances,="" epa="" is="" taking="" into="" account="" this="" conservative="" exposure="" assessment.="" the="" dietary="" risk="" evaluation="" system="" (dres)="" was="" used="" for="" the="" chronic="" dietary="" exposure="" analysis.="" the="" analysis="" evaluates="" individual="" food="" consumption="" as="" reported="" by="" respondents="" in="" the="" usda="" 1977-78="" nationwide="" food="" consumption="" survey="" (nfcs)="" and="" accumulates="" exposure="" to="" the="" chemical="" for="" each="" commodity.="" 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="" these="" 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.="" existing="" tolerances="" and="" this="" rule="" for="" canola="" and="" mint="" result="" in="" a="" tmrc="" of="" 5.40="" x="">-4 mg/kg/day for the U.S. general
population (48 States), which represents 6.0% of the RfD. The use on
canola will add a TMRC of 7.7 x 10-5 mg/kg/day, which
represents 0.9% of the RfD for the U.S. population. The use on mint
will add a TMRC of 2 x 10-6 mg/kg/day, which represents
0.016% of the RfD. Existing tolerances and this rule result in a TMRC
of 1.7 x 10-3 mg/kg/day for the highest exposed population
subgroup (non-nursing infants <1 year="" old),="" which="" represents="" 19%.="" these="" tolerances="" for="" canola="" and="" mint="" will="" not="" contribute="" to="" the="" dietary="" burden="" of="" this="" population="" subgroup.="" based="" on="" the="" risk="" estimates="" calculated,="" chronic="" dietary="" exposure="" does="" not="" exceed="" epa's="" level="" of="" concern.="" 2.="" from="" drinking="" water--="" i.="" acute="" exposure="" and="" risk.="" there="" are="" no="" acute="" toxicological="" concerns="" for="" quizalofop-p="" ethyl="" ester.="" ii.="" chronic="" exposure="" and="" risk.="" drinking="" water="" levels="" of="" concern="" (dwloc)="" were="" calculated="" for="" chronic="" dietary="" exposure.="" to="" calculate="" the="" dwloc,="" chronic="" dietary="" food="" exposure="" (from="" dres="" analysis)="" was="" subtracted="" from="" the="" rfd.="" dwloc="" were="" then="" calculated="" using="" default="" bodyweights="" and="" drinking="" water="" consumption="" figures.="" for="" adults,="" the="" estimate="" was="" based="" on="" a="" body="" weight="" of="" 60="" kg="" (female)/70="" kg(female)="" and="" consumption="" of="" 2="" liters="" of="" water="" per="" day.="" for="" children,="" a="" body="" weight="" of="" 10="" kg="" and="" a="" consumption="" of="" 1="" liter="" of="" water="" per="" day="" were="" used.="" the="" dwloc="" are="" calculated="" at="" 296="" parts="" per="" billion="" (ppb)="" for="" the="" u.s.="" population,="" 256="" ppb="" for="" females="" (13+="" years="" old,="" not="" pregnant="" or="" nursing)="" and="" 73="" ppb="" for="" infants="" and="" children.="" agency="" estimates="" for="" quizalofop-p="" ethyl="" ester="" contamination="" is="" 8="" ppb="" for="" surface="" water="" and="" 0.15="" ppb="" for="" groundwater.="" these="" levels="" are="" significantly="" less="" than="" levels="" of="" concern="" to="" epa.="" 3.="" from="" non-dietary="" exposure.="" quizalofop-p="" ethyl="" ester="" is="" not="" registered="" for="" residential="" use="" sites.="" 4.="" cumulative="" exposure="" to="" substances="" with="" common="" mechanism="" of="" toxicity.="" quizalofop-p="" ethyl="" is="" a="" member="" of="" the="" oxyphenoxy="" acid="" ester="" class="" of="" pesticides.="" other="" members="" of="" this="" class="" include="" fluazifop-="" butyl,="" diclofop-methyl,="" fenoxaprop-ethyl,="" and="" haloxyfop-methyl.="" 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="" [[page="" 32757]]="" 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="" quizalofop-p="" ethyl="" ester="" 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,="" quizalofop-p="" ethyl="" ester="" 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="" quizalofop-p="" ethyl="" ester="" has="" a="" common="" mechanism="" of="" toxicity="" with="" other="" substances.="" 5.="" endocrine="" disruption.="" epa="" is="" required="" to="" develop="" a="" screening="" program="" to="" determine="" whether="" certain="" substances="" (including="" all="" pesticides="" and="" inerts)="" ``may="" have="" an="" effect="" in="" humans="" that="" is="" similar="" to="" an="" effect="" produced="" by="" a="" naturally="" occurring="" estrogen,="" or="" such="" other="" endocrine="" effect....''="" the="" agency="" is="" currently="" working="" with="" interested="" stakeholders,="" including="" other="" government="" agencies,="" public="" interest="" groups,="" industry="" and="" research="" scientists="" in="" developing="" a="" screening="" and="" testing="" program="" and="" a="" priority="" setting="" scheme="" to="" implement="" this="" program.="" congress="" has="" allowed="" 3="" years="" from="" the="" passage="" of="" fqpa="" (august="" 3,="" 1999)="" to="" implement="" this="" program.="" epa="" may="" require="" further="" testing="" of="" this="" active="" ingredient="" and="" end="" use="" products="" for="" endocrine="" disrupter="" effects.="" d.="" aggregate="" risks="" and="" determination="" of="" safety="" for="" u.s.="" population="" 1.="" acute="" risk.="" there="" are="" no="" acute="" toxicological="" concerns="" for="" quizalofop-p="" ethyl="" ester.="" 2.="" chronic="" risk.="" using="" the="" tmrc="" exposure="" assumptions="" described="" above,="" epa="" has="" concluded="" that="" aggregate="" exposure="" to="" quizalofop-p="" ethyl="" ester="" from="" food="" will="" utilize="" 6.0%="" of="" the="" rfd="" for="" the="" u.s.="" population.="" the="" major="" identifiable="" subgroup="" with="" the="" highest="" aggregate="" exposure="" is="" non-nursing="" infants=""><1 year="" old="" at="" 19%="" 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.="" despite="" the="" potential="" for="" exposure="" to="" quizalofop-p="" ethyl="" ester="" in="" drinking="" water="" and="" from="" non-dietary,="" non-occupational="" exposure,="" 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="" quizalofop-p="" ethyl="" ester="" residues.="" e.="" aggregate="" cancer="" risk="" for="" u.s.="" population="" the="" agency="" has="" classified="" quizlopfop-p="" ethyl="" as="" a="" category="" d="" chemical="" (not="" classifiable="" as="" to="" human="" cancer="" potential)="" based="" on="" results="" of="" rat="" and="" mouse="" cancer="" studies="" along="" with="" other="" relevant="" short-term="" toxicity,="" mutagenicity="" studies,="" and="" structure-activity="" relationships.="" the="" group="" d="" classification="" is="" based="" on="" an="" approximate="" doubling="" in="" the="" incidence="" of="" mice="" liver="" tumors="" between="" controls="" and="" the="" high="" dose.="" this="" finding="" was="" not="" considered="" strong="" enough="" to="" warrant="" the="" classification="" of="" a="" category="" c="" (possible="" human="" carcinogen):="" the="" increase="" was="" of="" marginal="" statistical="" significance,="" occurred="" at="" high="" dose="" which="" exceeded="" the="" mtd,="" and="" occurred="" in="" a="" study="" in="" which="" the="" concurrent="" control="" for="" liver="" tumors="" was="" somewhat="" low="" as="" compared="" to="" the="" historical="" controls,="" while="" the="" high="" dose="" control="" group="" was="" at="" the="" upper="" end="" of="" previous="" historical="" control="" groups.="" based="" on="" results="" of="" the="" above="" adequate="" studies="" and="" the="" category="" d="" classification,="" the="" agency="" believes="" that="" any="" cancer="" risk="" posed="" by="" quizalofop-p="" ethyl="" is="" negligible="" and="" there="" is="" reasonable="" certainty="" that="" no="" harm="" will="" result="" from="" exposure="" to="" residue="" of="" quizalofop-p="" ethyl.="" 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="" quizalofop-p="" ethyl="" ester,="" epa="" considered="" data="" from="" developmental="" toxicity="" studies="" in="" the="" rat="" and="" rabbit="" and="" a="" two-="" 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.="" epa="" believes="" that="" reliable="" data="" support="" using="" the="" standard="" uncertainty="" factor="" (usually="" 100="" for="" combined="" inter-="" and="" intra-species="" variability))="" and="" not="" the="" additional="" tenfold="" moe/uncertainty="" factor="" when="" epa="" has="" a="" complete="" data="" base="" under="" existing="" guidelines="" and="" when="" the="" severity="" of="" the="" effect="" in="" infants="" or="" children="" or="" the="" potency="" or="" unusual="" toxic="" properties="" of="" a="" compound="" do="" not="" raise="" concerns="" regarding="" the="" adequacy="" of="" the="" standard="" moe/safety="" factor.="" ii.="" developmental="" toxicity="" studies.="" developmental="" toxicity="" studies="" showed="" no="" increased="" sensitivity="" in="" fetuses="" as="" compared="" to="" maternal="" animals="" following="" in="" utero="" exposures="" in="" rats="" and="" rabbits.="" iii.="" reproductive="" toxicity="" study.="" in="" a="" two="" generation="" reproductive="" toxicity="" study,="" rats="" were="" fed="" diets="" of="" 0,="" 1.25,="" 5.0="" or="" 20="" mg/kg/day="" of="" quizalofop-p="" ethyl.="" the="" parental="" noel="" was="" 5.0="" mg/kg/day="" and="" the="" loel="" was="" 20="" mg/kg/day,="" based="" on="" decreased="" body="" weights="" in="" males="" of="" both="" generations.="" the="" developmental="" noel="" for="" effects="" on="" the="" offspring="" was="" 1.25="" mg/kg/day="" and="" the="" offspring="" developmental="" loel="" was="" 5.0="" mg/kg/day,="" based="" on="" increased="" incidence="" of="" eosinophilic="" changes="" in="" the="" livers="" of="" f2="" weanling.="" in="" addition,="" at="" 20="" mg/kg/day,="" reductions="" in="" litter="" size,="" survival,="" body="" weights,="" and="" spleen="" weight="" were="" seen="" in="" the="" offspring.="" iv.="" pre-="" and="" post-natal="" sensitivity.="" the="" histopathology="" data="" for="" f2="" weanlings="" in="" the="" two-generation="" reproductive="" toxicity="" study="" suggested="" an="" increased="" sensitivity="" to="" the="" offspring.="" in="" that="" study,="" an="" increase="" in="" the="" incidence="" of="" eosinophilic="" changes="" in="" the="" liver="" were="" noted="" in="" the="" f2="" weanlings,="" and="" the="" offspring="" noel="" was="" less="" than="" the="" parental="" systemic="" noel.="" however,="" the="" significance="" of="" these="" observations="" in="" the="" two-generation="" reproductive="" toxicity="" study="" is="" rendered="" questionable="" due="" to:="" (a)="" the="" changes="" in="" the="" weanling="" livers="" were="" not="" well="" characterized;="" (b)="" the="" biological="" significance="" of="" this="" endpoint="" was="" not="" known;="" (c)="" the="" precise="" dose="" of="" test="" substance="" to="" 21-day="" old="" weanlings="" cannot="" be="" determined="" with="" any="" accuracy,="" but="" it="" is="" likely="" to="" exceed="" that="" of="" the="" adults;="" (d)="" this="" endpoint="" [[page="" 32758]]="" (eosinophilic="" changes),="" in="" adults,="" would="" not="" be="" considered="" appropriate="" for="" use="" in="" regulation="" of="" a="" chemical="" because="" of="" the="" questionable="" biological="" significance="" of="" this="" effect;="" and,="" (e)="" previous="" toxicological="" studies="" show="" the="" liver="" as="" the="" target="" organ="" in="" rats.="" no="" particular="" significance="" to="" the="" offspring="" is="" attributed="" to="" the="" liver="" effects.="" v.="" conclusion.="" the="" database="" is="" complete="" and="" the="" weight="" of="" the="" evidence="" reveals="" no="" special="" susceptibility="" to="" developmental="" toxicity.="" therefore,="" epa="" has="" determined="" that="" reliable="" data="" support="" use="" of="" the="" standard="" 100-fold="" safety="" factor.="" an="" additional="" ten-fold="" safety="" factor="" is="" not="" necessary="" to="" protect="" the="" safety="" of="" infants="" and="" children.="" 2.="" acute="" aggregate="" risk.="" there="" are="" no="" acute="" toxicological="" concerns="" for="" quizalofop-p="" ethyl="" ester.="" 3.="" chronic="" aggregate="" risk.="" using="" the="" conservative="" exposure="" assumptions="" described="" above,="" epa="" has="" concluded="" that="" aggregate="" exposure="" to="" quizalofop-p="" ethyl="" ester="" from="" food="" will="" utilize="" 19%="" of="" the="" rfd="" for="" the="" highest="" exposed="" population="" subgroup="" (non-nursing="" infants=""><1 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.="" because="" there="" are="" no="" indoor="" or="" outdoor="" residential="" uses="" for="" quizalofop-p="" ethyl,="" and="" the="" estimates="" of="" quizalofop-p="" ethyl="" chronic="" residues="" in="" drinking="" water="" are="" much="" less="" (estimated="" at="" 8.08="" ppb)="" than="" the="" 73="" ppb="" concern="" level,="" aggregate="" (food,="" water,="" and="" residential)="" chronic="" exposure="" for="" infants,="" children,="" and="" adults="" will="" not="" exceed="" the="" agency's="" level="" of="" concern.="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" to="" infants="" and="" children="" from="" aggregate="" exposure="" to="" quizalofop-p="" ethyl="" ester="" residues.="" 4.="" short-="" or="" intermediate-term="" risk.="" because="" no="" toxicological="" endpoints="" have="" been="" identified="" for="" short-,="" intermediate-,="" and/or="" chronic-term="" dermal="" or="" inhalation="" exposures,="" the="" agency="" believes="" there="" is="" reasonable="" certainty="" that="" no="" harm="" will="" result="" from="" exposure="" to="" quizalofop-p="" ethyl="" due="" to="" approved="" tolerances.="" iii.="" other="" considerations="" a.="" metabolism="" in="" plants="" and="" animals="" the="" agency="" has="" previously="" concluded="" that="" the="" nature="" of="" the="" quizalofop-p="" ethyl="" residue="" in="" plants="" is="" adequately="" understood.="" the="" residues="" of="" concern="" are="" quizalofop-p="" ethyl="" ester="" and="" its="" acid="" metabolite,="" quizalofop-p,="" and="" the="" s="" enantiomers="" of="" both="" the="" ester="" and="" the="" acid,="" all="" expressed="" as="" quizalofop-p="" (40="" cfr="" 180.441(c)).="" in="" animals,="" the="" residues="" of="" concern="" are="" slightly="" different="" and="" include="" quizalofop="" ethyl,="" quizalofop="" methyl,="" and="" quizalofop="" acid,="" all="" expressed="" as="" quizalofop-ethyl="" (40="" cfr="" 180.441(b)).="" b.="" analytical="" enforcement="" methodology="" an="" adequate="" enforcement="" method="" for="" determination="" of="" quizalofop-p-="" ethyl="" and="" related="" regulated="" residues="" is="" available="" in="" pam="" ii.="" c.="" magnitude="" of="" residues="" the="" maximum="" residues="" detected="" on="" fresh="" mint="" foliage="" at="" the="" proposed="" labeled="" level="" of="" dupont's="" product,="" assure,="" of="" 0.2="" pounds(lbs)="" active="" ingredient(ai)="" per="" acre="" (1x)="" applied="" 30="" days="" before="" harvest="" were="" 0.22,="" 0.46,="" and="" 1.0="" ppm="" for="" indiana,="" oregon="" and="" washington,="" respectively.="" the="" largest="" residue="" found="" on="" fresh="" mint="" foliage,="" 2.6="" ppm,="" was="" detected="" in="" a="" washington="" sample="" treated="" with="" 0.4="" lbs.="" per="" acre="" (2x)="" 29="" days="" before="" harvest,="" twice="" the="" maximum="" yearly="" rate="" allowed.="" at="" the="" level="" of="" quantitation="" (loq)="" of="" 0.05="" ppm,="" there="" were="" no="" detectable="" residues="" in="" the="" mint="" oil,="" either="" at="" the="" proposed="" label="" rate="" of="" 0.2="" lbs.="" ai/acre(a),="" or="" at="" the="" exaggerated="" rate="" of="" 0.4="" lbs.="" ai/a,="" indicating="" that="" quizalofop-p="" ethyl="" and="" its="" acid="" metabolite="" are="" not="" concentrated="" during="" the="" oil="" distillation="" process.="" adequate="" residue="" data="" were="" provided="" to="" support="" a="" tolerance="" of="" 2.0="" ppm="" for="" mint.="" there="" are="" no="" livestock="" feedstuffs="" associated="" with="" mint.="" adequate="" residue="" data="" were="" provided="" to="" support="" proposed="" tolerances="" canola="" seed="" and="" canola="" meal.="" processing="" data="" provided="" for="" canola="" seed="" indicated="" concentration="" in="" canola="" meal.="" based="" on="" the="" concentration="" factor="" of="" 2.3x="" and="" the="" highest="" average="" field="" trial="" (haft)="" residue="" level="" of="" 0.65="" ppm="" for="" canola="" seed,="" a="" tolerance="" at="" 1.5="" ppm="" for="" canola="" meal="" is="" considered="" adequate.="" results="" of="" a="" ruminant="" feeding="" study="" lead="" to="" the="" conclusion="" that="" the="" established="" quizalofop="" and="" quizalofop-p="" ethyl="" tolerance="" in="" milk,="" and="" in="" fat,="" meat,="" and="" meat="" by-products="" of="" cattle,="" goats,="" hogs,="" horse,="" and="" sheep="" are="" adequate="" and="" need="" not="" be="" increased="" from="" the="" additional="" use="" on="" canola.="" additionally,="" the="" established="" tolerances="" of="" quizalofop="" and="" quizalofop-p="" ethyl="" in="" eggs,="" and="" in="" fat,="" meat,="" and="" meat="" by-products="" of="" poultry="" are="" adequate="" and="" need="" not="" be="" changed="" from="" the="" additional="" use="" on="" canola.="" d.="" international="" residue="" limits="" there="" are="" no="" codex,="" canadian,="" or="" mexican="" maximum="" residue="" limits="" (mrls)="" for="" quizalofop-p="" ethyl="" residues="" in/on="" mint.="" since="" there="" are="" no="" mexican="" or="" codex="" mrls/tolerances="" for="" quizalofop-p-ethyl="" in/on="" canola="" seed,="" compatibility="" is="" not="" a="" problem="" at="" this="" time.="" compatibility="" cannot="" be="" achieved="" with="" the="" canadian="" negligible="" residue="" types="" limit="" at="" 0.1="" ppm="" as="" the="" u.s.="" use="" pattern="" had="" findings="" of="" real="" residues="" above="" 0.1="" ppm.="" additionally,="" the="" canadian="" mrl="" is="" in="" terms="" of="" parent="" only,="" thus="" the="" tolerance="" expressions="" are="" not="" compatible.="" e.="" rotational="" crop="" restrictions="" available="" data="" support="" a="" 120="" day="" plant="" back="" interval.="" iv.="" conclusion="" therefore,="" tolerances="" are="" established="" for="" combined="" residues="" of="" quizalofop-p="" ethyl="" ester="" [ethyl="" (r)-(2[4-((6-chloroquinoxalin-2-="" yl)oxy)phenoxyl]-propanoate),="" and="" its="" acid="" metabolite="" quizalofop-p="" [r-="" (2-[4-((6-chloroquinoxalin-2-yl)oxy)phenoxyl)propionate="" and="" the="" s="" enantiomers="" of="" the="" ester="" and="" the="" acid,="" all="" expressed="" as="" quizalofop-p="" ethyl="" ester="" in="" or="" on="" canola="" seed="" at="" 1.0="" ppm,="" canola="" meal="" at="" 1.5="" ppm,="" and="" peppermint="" tops="" and="" spearmint="" tops="" at="" 2.0="" ppm.="" 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="" august="" 17,="" 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="" [[page="" 32759]]="" statement="" of="" the="" factual="" issues="" on="" which="" a="" hearing="" is="" requested,="" the="" requestor's="" contentions="" on="" such="" issues,="" and="" a="" summary="" of="" any="" evidence="" relied="" upon="" by="" the="" requestor="" (40="" cfr="" 178.27).="" a="" request="" for="" a="" hearing="" will="" be="" granted="" if="" the="" administrator="" determines="" that="" the="" material="" submitted="" shows="" the="" following:="" there="" is="" genuine="" and="" substantial="" issue="" of="" fact;="" there="" is="" a="" reasonable="" possibility="" that="" available="" evidence="" identified="" by="" the="" requestor="" would,="" if="" established,="" resolve="" one="" or="" more="" of="" such="" issues="" in="" favor="" of="" the="" requestor,="" taking="" into="" account="" uncontested="" claims="" or="" facts="" to="" the="" contrary;="" and="" resolution="" of="" the="" factual="" issues="" in="" the="" manner="" sought="" by="" the="" requestor="" would="" be="" adequate="" to="" justify="" the="" action="" requested="" (40="" cfr="" 178.32).="" information="" submitted="" in="" connection="" with="" an="" objection="" or="" hearing="" request="" may="" be="" claimed="" confidential="" by="" marking="" any="" part="" or="" all="" of="" that="" information="" as="" cbi.="" information="" so="" marked="" will="" not="" be="" disclosed="" except="" in="" accordance="" with="" procedures="" set="" forth="" in="" 40="" cfr="" part="" 2.="" a="" copy="" of="" the="" information="" that="" does="" not="" contain="" cbi="" must="" be="" submitted="" for="" inclusion="" in="" the="" public="" record.="" 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-300663]="" (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 this rule in the Federal Register. This rule is not a
``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects
40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
40 CFR Part 185
Environmental protection, Food additives, Pesticides and pests.
40 CFR Part 186
Environmental protection, Animal feeds, Pesticides and pests.
Dated: May 28, 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 180.441 is revised to read as follows:
Sec. 180.441 Quizalofop ethyl; tolerances for residues.
(a) General. (1) Tolerances are established for the combined
residues of the herbicide quizalofop (2-[4-(6-chloroquinoxalin-2-yl
oxy)phenoxy]propanoic acid) and quizalofop ethyl (ethyl-2-[4-(6-
chloroquinoxalin-2-yl oxy)phenoxy]propanoate), all expressed as
quizalofop ethyl, in or on the following agricultural commodities:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Soybean flour............................................... 0.5
Soybean hulls............................................... 0.02
Soybean meal................................................ 0.5
Soybean soapstock........................................... 1.0
Soybeans.................................................... 0.05
------------------------------------------------------------------------
[[Page 32760]]
(2) Tolerances are established for the combined residues of the
herbicide quizalofop (2-[4-(6-chloroquinoxalin-2-yl
oxy)phenoxy]propanoic acid), quizalop-ethyl (ethyl-2-[4-(6-
chloroquinoxalin-2-yl oxy)phenoxy]propanoate), and quizalofop-methyl
(methyl 2-[4-(6-chloroquinoxalin-2-yl-oxy)phenoxy]propanoate, all
expressed as quizalofop ethyl, as follows:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Cattle, fat................................................. 0.05
Cattle, meat................................................ 0.02
Cattle, mbyp................................................ 0.05
Eggs........................................................ 0.02
Goats, fat.................................................. 0.05
Goats, meat................................................. 0.02
Goats, mbyp................................................. 0.05
Hogs, fat................................................... 0.05
Hogs, meat.................................................. 0.02
Hogs, mbyp.................................................. 0.05
Horses, fat................................................. 0.05
Horses, meat................................................ 0.02
Horses, mbyp................................................ 0.05
Milk........................................................ 0.01
Milk, fat................................................... 0.05
Poultry, fat................................................ 0.05
Poultry, meat............................................... 0.02
Poultry, mbyp............................................... 0.05
Sheep, fat.................................................. 0.05
Sheep, meat................................................. 0.02
Sheep, mbyp................................................. 0.05
------------------------------------------------------------------------
(3) Tolerances are established for the combined residues of the
herbicide quizalofop-p ethyl ester [ethyl (R)-(2-[4-((6-
chloroquinoxalin-2-yl)oxy)phenoxy)propanoate], and its acid metabolite
quizalofop-p [R-(2-(4-((6-quinoxalin-2-yl)oxy)phenoxy)propanoic acid],
and the S enantiomers of both the ester and the acid, all expressed as
quizalofop-p-ethyl ester, in or on the following raw agricultural
commodities;
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Canola, meal................................................ 1.5
Canola, seed................................................ 1.0
Cottonseed.................................................. 0.1
Lentils..................................................... 0.05
Peppermint, tops............................................ 2.0
Spearmint, tops............................................. 2.0
------------------------------------------------------------------------
(4) Time limited tolerances to expire on June 14, 1999 are
established for the combined residues of the herbicide quizalofop-p
ethyl ester (ethyl (R)-(2-(4-((6-chloroquinoxalin-2-
yl)oxy)phenoxy)propanoate) and it acid metabolite quizalofop-p [R-(2-
(4-((6-chloroquinoxalin-2-yl)oxy)phenoxy)propanoic acid), and the S
enantiomers of both the ester and the acid, all expressed as
quizalofop-p-ethyl ester in or on the following raw agricultural
commodities:
------------------------------------------------------------------------
Parts per
Commodities million
------------------------------------------------------------------------
Foliage of legume vegetables (except soybeans).............. 3.0
Legume vegetables (succulent or dried) group................ 0.25
Sugarbeet molasses.......................................... 0.2
Sugarbeet, root............................................. 0.1
Sugarbeet, top.............................................. 0.5
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. Tolerances with
regional registration, as defined in Sec. 180.1(n), are established for
the combined residues of the herbicide quizalofop-p ethyl ester [ethyl
(R)-2-[4-((6-chloroquinoxalin-2-yl)oxy)phenoxy] propionate], its acid
metabolite quizalofop-p [R-(2-[4-((6-chloroquinoxalin-2-
yl)oxy)phenoxy]) propanoic acid], and the S enantiomers of both the
ester and the acid, all expressed as quizalofop-p ethyl ester, in or
the raw agricultural commodities, as follows:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Pineapple................................................... 0.1
------------------------------------------------------------------------
(d) Indirect or inadvertent residues. [Reserved]
PART 185-- [AMENDED]
3. In part 185:
a. The authority citation for part 185 continues to read as
follows:
Authority: 21 U.S.C. 346a and 348.
Sec. 185.5250 [Removed]
b. Section Sec. 185.5250 is removed.
PART 186-- [AMENDED]
4. In part 186:
a. The authority citation for part 186 continues to read as
follows:
Authority: 21 U.S.C. 342, 348, and 701.
Sec. 186.5250 [Removed]
b. Section Sec. 186.5250 is removed.
[FR Doc. 98-15746 Filed 6-15-98; 8:45 am]
BILLING CODE 6560-50-F
