[Federal Register Volume 63, Number 37 (Wednesday, February 25, 1998)]
[Proposed Rules]
[Pages 9494-9499]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-4804]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300619; FRL-5772-7]
RIN 2070-AB78
Prometryn; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA proposes to establish tolerances for residues of prometryn
in or on carrots under its own initiative to harmonize tolerances with
Canada under the Federal Food, Drug and Cosmetic Act (FFDCA), as
amended by the Food Quality Protection Act of 1966 (Pub. L. 104-170).
DATES: Comments, identified by the document control number [OPP-
300619], must be received on or before March 27, 1998.
ADDRESSES: By mail, submit written comments to: Public Response and
Program Resources Branch, Field Operations Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, M St., SW,
Washington, DC 20460. In person, bring comments to: Rm. 119, Crystal
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202.
Comments and data may also be submitted electronically to: docket@epamail.epa.gov. Follow the instructions under Unit V. of this
document.
Information submitted as a comment concerning this notice may be
claimed confidential by marking any part or all of that information as
``Confidential Business Information'' (CBI). Information so marked will
not be disclosed except in accordance with procedures set forth in 40
CFR part 2. A copy of the comment 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. All
written comments will be available for public inspection in Rm. 119 at
the address given above, from 8 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays.
FOR FURTHER INFORMATION CONTACT: By mail: James A. Tompkins,
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
Office location, telephone number, and e-mail address: Crystal Mall #2,
1921 Jefferson Davis Hwy., Arlington, VA, (703) 308-5697, e-mail:
tompkins.james@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA is proposing under its own initiative
that 40 CFR 180.222 be amended by establishing tolerances for residues
of the herbicide prometryn, 2,4-bis(isopropylamino)-6-methylthio-s-
triazine in or on carrots at 0.1 parts per million (ppm) without a U.S.
registration under the Federal Insecticide Fungicide Act (FIFRA), as
amended for carrots imported from Canada.
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
[[Page 9495]]
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 3
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
[[Page 9496]]
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 >1 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
prometryn, and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for a tolerance for residues of
prometryn and its metabolite on carrots at 0.1 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 prometryn are
discussed below.
1. A rat acute oral study with a LD50 of 1,802
milligrams/kilogram (mg/kg) for males and a LD50 of 2,076
mg/kg for females
2. A 28-day mice pilot feeding study with a No Observed Effect
Level (NOEL) of 450 milligrams/kilogram/day (mg/kg/day) and a Lowest
Observed Effect Level (LOEL) of 1,500 mg/kg/day based on decreased body
weights.
3. A 21-day dermal toxicity study with a NOEL and LOEL greater than
of 1,000 mg/kg/day the highest dose tested (HDT).
4. A 102-week chronic feeding/carcinogenicity study in mice with a
Systemic NOEL of 100 mg/kg/day for females and a Systemic LOEL of 300
mg/kg/day for females based on decreased body weight gain. No effects
were observed in males. Although significant toxicity was observed only
in females, the Health Effects Division Reference Dose (RfD) committee
considered the study adequate since (1) levels were close to one-half
the limit dose in mice; (2) no effects were noted in the study to
warrant repeating the study at high dose levels; and (3) all tumors
noted with other members of the s-triazine class were mainly in rats
and not mice.
5. A 2-year rat chronic feeding/carcinogenicity study with a
Systemic NOEL of 29.45 mg/kg/day for males and 37.25 mg/kg/day for
females and a Systemic LOEL of 60.88 mg/kg/day for males and 80.62 mg/
kg/day for females based on decreased body weight and body weight gain
and an increase in the incidence of renal lesions (mineralized
concretions) in males. prometryn was not oncogenic under the conditions
of the study.
6. A 106-week dog feeding study with a NOEL of 3.75 mg/kg/day and a
LOEL of 37.5 mg/kg/day based on degenerative hepatic changes, renal
tubule degeneration, and bone marrow atrophy. Prometryn was not
oncogenic under the conditions of the study.
7. A developmental toxicity study in rats with a Maternal and
Developmental NOEL of 50 mg/kg and a Maternal LOEL of 250 mg/kg based
on salivation and decreases in body weight and food consumption. The
Developmental LOEL is 250 mg/kg/day based on significantly decreased
and incomplete ossification in the sternebrae and metacarpals.
8. A developmental toxicity study in rabbits with a Maternal and
Developmental NOEL of 12 mg/kg/day and a Maternal LOEL of 72 mg/kg
based on based on decreased food consumption, and the Developmental
LOEL of 72 mg/kg/day, based on increased fetal resorptions.
9. A two-generation reproduction study in rats with a Parental
Systemic NOEL of 0.6 mg/kg/day in males and 0.7 mg/kg/day in females
and a Parental Systemic LOEL of 47.8 mg/kg/day in males and 53.6 mg/kg/
day in females based on decreased food consumption, body weight and
body weight gain. The Reproductive Systemic NOEL is 0.65 mg/kg/day and
the Reproductive Systemic LOEL is approximately 50 mg/kg/day, based on
decreased pup weight.
10. An Ames salmonella test, prometryn was negative for gene
mutation up to cytotoxic solubility limits (1,000-2,000 g/
plate). A chromosomal aberration in vivo Chinese hamster bone marrow
test, prometryn was negative for nuclear anomalies (micronuclei) when
animals were dosed orally up to 5,000 mg/kg. Prometryn was negative for
bacterial DNA repair and gene mutation up to precipitating levels
(1,000 g/plate). An unscheduled DNA synthesis test prometryn
was negative (measured as UDS) in rat hepatocytes cultured in vitro up
to cytotoxic levels (156.25 g/mL).
11. Rat metabolism studies showed that radio labeled prometryn is
distributed in blood greater than spleen greater than lungs (the three
highest tissues measured). Distribution is not dosage-dependant. It is
extensively metabolized with less than 2% of recovered 14C
radioactivity representing the parent compound. Twenty-eight
metabolites were identified in the urine, and 28 in the feces. Ten
metabolites were identified in both urine and feces. Prometryn is
excreted predominantly in the urine and feces, with slightly higher
concentrations in the urine. The 7-day recovery of 14C
radioactivity averaged 95% for all dosing groups.
B. Toxicological Endpoints
1. Acute toxicity. The developmental NOEL of 12 mg/kg/day from a
developmental study was recommend for the acute dietary risk
assessment.
2. Short - and intermediate - term toxicity. The developmental NOEL
of 12 mg/kg/day from a developmental study was recommend for the short-
and intermediate- term dermal and inhalation risk assessments.
3. Chronic toxicity. EPA has established the RfD for prometryn at
0.04 mg/kg/day. This RfD is based on upon the chronic feeding study in
dogs with a NOEL of 3.75 mg/kg/day with a 100-fold safety factor to
account for interspecies extrapolation and intraspecies variability.
4. Carcinogenicity. The Health Effects Division Reference Dose
(RfD) Committee classified prometryn as a
[[Page 9497]]
Group E chemical (no evidence of human carcinogenic potential).
C. Exposures and Risks
1. From food and feed uses. Tolerances have been established (40
CFR 180.222(a)) for the residues of prometryn, 2,4-bis(isopropylamino)-
6-methylthio-s-triazine, in celery at 0.5 ppm; corn forage, fresh corn
and corn grain at 0.25 ppm; cotton at 1 ppm: cottonseed at 0.25 ppm;
and pigeon peas at 0.25 ppm.. Tolerances with regional registration
have been established (40 CFR 180.222(b)) for the residues of prometryn
in dill at 0.3 ppm and parsley at 0.1 ppm. Risk assessments were
conducted by EPA to assess dietary exposures and risks from prometryn
as follows:
i. Acute exposure and risk. Acute dietary risk assessments are
performed for a 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. The Margin of Exposure (MOE) value for females (13
years and older) was 1,200,000. This value is significantly higher than
the Agency's level of concern of 100 which is adequate to ensure
protection for females 13 and older..
ii. Chronic exposure and risk. Assuming 100% of the crop are
treated and residues are at tolerance levels the theoretical maximum
residue contribution (TMRC) from the established and proposed
tolerances is 0.000056 mg/kg/day and utilizes less than 1% of the RfD
for the U.S. Population. For exposure of the most highly exposed
subgroup in the population, non-nursing infants, the TMRC is 0.0016 mg/
kg/day which utilizes less than 1% of the RfD.
2. From drinking water. Despite the potential for exposure through
drinking water, EPA has concluded that the percentage of the RfD that
will be utilized by dietary exposure (including drinking water
exposure) to residues of prometryn does not exceed 100% for any of the
population subgroups. Considering food only, the population subgroup
with the largest percentage of the RfD occupied is 0.0000056 mg/kg/day
at < 1%="" of="" the="" rfd.="" therefore="" taking="" into="" account="" the="" completeness="" and="" reliability="" of="" the="" toxicity="" data="" and="" the="" conservative="" exposure="" assessment,="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" to="" infants="" and="" children="" from="" aggregate="" exposure="" to="" prometryn="" residues.="" 3.="" from="" non-dietary="" exposure.="" prometryn="" is="" currently="" not="" registered="" for="" residential="" use="" such="" as="" turf="" and="" ornamentals.="" therefore="" there="" is="" no="" expectation="" of="" non-occupational="" residential="" exposures.="" 4.="" cumulative="" exposure="" to="" substances="" with="" common="" mechanism="" of="" toxicity.="" prometryn="" is="" a="" member="" of="" the="" triazine="" class="" of="" pesticides.="" other="" members="" of="" this="" class="" include="" atrazine,="" simazine,="" cyanazine,="" prometon,="" propazine,="" metribuzin,="" hexazinone,="" ametryn,="" terbutryne,="" dipropetryn,="" and="" ethiozin.="" 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="" prometryn="" has="" a="" common="" mechanism="" of="" toxicity="" with="" other="" substances="" or="" how="" to="" include="" this="" pesticide="" in="" a="" cumulative="" risk="" assessment.="" the="" agency="" has="" determined="" that="" there="" are="" no="" metabolites="" of="" toxicological="" concern="" associated="" with="" prometryn.="" for="" the="" purposes="" of="" this="" tolerance="" action,="" therefore,="" epa="" has="" not="" assumed="" that="" prometryn="" has="" a="" common="" mechanism="" of="" toxicity="" with="" other="" substances.="" d.="" 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="" prometryn,="" 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="" pesticide="" exposure="" during="" prenatal="" development="" to="" one="" or="" both="" parents.="" 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="" moe="" and="" uncertainty="" factor="" (usually="" 100="" for="" 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="" and="" reproductive="" toxicity="" studies.="" the="" pre-="" and="" post-natal="" toxicology="" data="" base="" for="" prometryn="" is="" complete="" with="" respect="" to="" current="" toxicological="" data="" requirements.="" the="" results="" of="" these="" studies="" indicate="" that="" infants="" and="" children="" are="" not="" more="" [[page="" 9498]]="" sensitive="" to="" exposure,="" based="" on="" the="" results="" of="" the="" oral="" rat="" and="" rabbit="" developmental="" toxicity="" studies="" and="" the="" 2-generation="" reproductive="" toxicity="" study="" in="" rats.="" the="" developmental="" studies="" in="" rats="" and="" rabbits="" both="" have="" the="" maternal="" noels="" and="" loels,="" respectively,="" and="" demonstrate="" that="" no="" prenatal="" extra="" sensitivity="" is="" present.="" however,="" based="" on="" the="" developmental="" effects="" observed="" in="" rabbits,="" an="" acute="" dietary="" risk="" assessment="" was="" performed="" for="" women="" age="" 13="" and="" older.="" the="" moe="" was="" calculated="" as="" 1,200,000.="" therefore,="" epa="" concludes="" that="" reliable="" data="" support="" use="" of="" the="" standard="" 100-fold="" margin="" of="" exposure/uncertainty="" factor="" and="" that="" an="" additional="" tenfold="" safety="" factor="" is="" not="" needed="" to="" protect="" infants="" and="" children.="" 2.="" acute="" risk.="" the="" acute="" aggregate="" dietary="" moe="" was="" calculated="" to="" be="" 1,200,000="" for="" females="" age="" 13="" and="" older="" (accounts="" for="" both="" maternal="" and="" fetal="" exposure),="" the="" population="" subgroup="" of="" concern.="" the="" moe="" calculations="" were="" based="" on="" the="" developmental="" noel="" in="" rabbits="" of="" 12="" mg/="" kg.="" this="" risk="" assessment="" assumed="" 100%="" of="" the="" crop="" was="" treated="" with="" tolerance="" level="" residues="" on="" all="" treated="" crops="" consumed,="" resulting="" in="" a="" significant="" over="" estimate="" of="" dietary="" exposure.="" the="" large="" acute="" dietary="" moe="" calculated="" for="" females="" age="" 13="" and="" older="" provides="" assurance="" the="" there="" is="" a="" reasonable="" certainty="" of="" no="" harm="" for="" infants="" and="" children="" to="" prometryn.="" 3.="" chronic="" risk.="" using="" the="" conservative="" exposure="" assumptions="" described="" above,="" epa="" has="" concluded="" that="" aggregate="" exposure="" to="" prometryn="" from="" food="" will="" utilize="" less="" than="" 1%="" of="" the="" rfd="" for="" infants="" and="" children.="" epa="" generally="" has="" no="" concern="" for="" exposures="" below="" 100%="" of="" the="" rfd="" because="" the="" rfd="" represents="" the="" level="" at="" or="" below="" which="" daily="" aggregate="" dietary="" exposure="" over="" a="" lifetime="" will="" not="" pose="" appreciable="" risks="" to="" human="" health.="" there="" are="" no="" chronic="" exposure="" scenarios="" of="" non-="" dietary="" uses="" of="" prometryn="" which="" would="" contribute="" to="" the="" aggregate="" risk.="" taking="" into="" account="" the="" completeness="" and="" reliability="" of="" the="" toxicity="" data="" and="" the="" conservative="" exposure="" assessment,="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" to="" infants="" and="" children="" from="" aggregate="" exposure="" to="" prometryn="" residues.="" iii.="" other="" considerations="" a.="" metabolism="" in="" plants="" and="" animals="" the="" metabolism="" of="" prometryn="" in="" plants="" and="" animals="" is="" adequately="" understood="" for="" purposes="" of="" this="" tolerance.="" b.="" analytical="" enforcement="" methodology="" an="" adequate="" analytical="" method,="" gas="" chromatograph="" is="" available="" in="" pam="" vol.="" ii,="" for="" plant="" to="" enforce="" the="" tolerance="" expression.="" c.="" magnitude="" of="" residues="" the="" nature="" of="" the="" residue="" in="" plants="" is="" adequately="" understood="" for="" the="" purposes="" of="" this="" tolerance.="" secondary="" residues="" in="" animals="" commodities="" are="" not="" expected="" to="" exceed="" existing="" tolerances="" as="" result="" to="" this="" use="" in="" canada.="" d.="" international="" residue="" limits="" there="" are="" no="" codex="" or="" mexican="" limits="" for="" prometryn="" on="" carrots.="" this="" proposal="" will="" harmonize="" tolerances="" with="" 0.1="" pm="" canadian="" maximum="" limit="" for="" residues="" in="" carrots.="" e.="" rotational="" crop="" restrictions="" since="" the="" use="" is="" on="" carrots="" grown="" in="" canada,="" rotational="" crop="" issues="" are="" not="" relevant.="" iv.="" conclusion="" there="" are="" presently="" no="" actions="" pending="" against="" the="" continued="" registration="" of="" this="" chemical.="" based="" on="" the="" information="" and="" data="" considered,="" the="" agency="" has="" determined="" that="" the="" tolerance="" established="" by="" amending="" 40="" cfr="" 180.222="" would="" protect="" the="" public="" health.="" therefore,="" it="" is="" proposed="" that="" tolerances="" be="" established="" for="" residues="" of="" prometryn="" in="" carrots="" at="" 0.1="" ppm.="" v.="" public="" docket="" epa="" has="" established="" a="" record="" for="" this="" rulemaking="" under="" docket="" control="" number="" [opp-300619]="" (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 from of encryption.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper from. Accordingly,
EPA will transfer any copies of comments received electronically into
printed, paper from 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.
VI. Regulatory Assessment Requirements
Under Executive Order 12866 (58 FR 51735, Oct. 4, 1993), the Agency
must determine whether the regulatory action is ``significant'' and
therefore subject to all the requirements of the Executive Order (i.e.,
Regulatory Impact Analysis, review by the Office of Management and
Budget (OMB)). Under section 3(f), the order defines ``significant'' as
those actions likely to lead to a rule (1) having an annual effect on
the economy of $100 million or more, or adversely and materially
affecting a sector of the economy, productivity, competition, jobs, the
environment, public health or safety, or State, local or tribal
governments or communities (also known as ``economically
significant''); (2) creating serious inconsistency or otherwise
interfering with an action taken or planned by another agency; (3)
materially altering the budgetary impacts of entitlement, grants, user
fees, or loan programs; or (4) raising novel legal or policy issues
arising out of legal mandates, the President's priorities, or the
principles set forth in this Executive Order. Pursuant to the terms of
this Executive Order, EPA has determined that this proposed rule is not
``significant'' and is therefore not subject to OMB review. Pursuant to
the requirements of the Regulatory Flexibility Act (Pub. L. 96-354, 94
Stat. 1164, 5 U.S.C. 601-612), the Administrator has determined that
regulations establishing new tolerances or raising tolerance levels or
establishing exemptions from tolerance requirements do not have a
significant economic impact on a substantial number of small entities.
A certification statement to this effect was published in the Federal
Register of May 4, 1981 (46 FR 24950).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
[[Page 9499]]
Dated: February 17, 1998.
James Jones,
Director, Registration Division, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR Part 180 be 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. In Sec. 180.222 by amending paragraph (a) by alphabetically
adding the following commodity to the table to read as follows:
Sec. 180.222 Prometryn; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * * * *
Carrots1................................................... 0.1
* * * * * * *
------------------------------------------------------------------------
\1\There are no U.S. registrations as of February 25, 1998 for use on
carrots.
* * * * *
[FR Doc. 98-4804 Filed 2-24-98; 8:45 am]
BILLING CODE 6560-50-F
