[Federal Register Volume 62, Number 120 (Monday, June 23, 1997)]
[Notices]
[Pages 33864-33868]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-16355]
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ENVIRONMENTAL PROTECTION AGENCY
[PF-745; FRL-5722-8]
Notice of Filing of Pesticide Petitions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces the initial filing of pesticide
petitions proposing the establishment of regulations for residues of
certain pesticide chemicals in or on various food commodities.
DATES: Comments, identified by the docket control number PF-745, must
be received on or before July 23, 1997.
ADDRESSES: By mail submit written comments to: Public Information and
Records Integrity Branch, Information Resources and Services Division
(7506C), Office of Pesticides Programs, Environmental Protection
Agency, 401 M St., SW., Washington, DC 20460. In person bring comments
to: Rm. 1132, CM #2, 1921 Jefferson Davis Highway, Arlington, VA.
Comments and data may also be submitted electronically by following
the instructions under ``SUPPLEMENTARY INFORMATION.'' No confidential
business information should be submitted through e-mail.
Information submitted as a comment concerning this document may be
claimed confidential by marking any part or all of that information as
``Confidential Business Information'' (CBI). CBI should not be
submitted through e-mail. Information marked as CBI 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. 1132 at the
address given above, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays.
FOR FURTHER INFORMATION CONTACT: By mail: Jim Tompkins, Product Manager
(PM) 25, Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
Office location, telephone number, and e-mail address: Rm. 239, CM #2,
1921 Jefferson Davis Highway, Arlington, VA 22202, 703-305-5697, e-
mail: miller.joanne@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA has received pesticide petitions as
follows proposing the establishment and/or amendment of regulations for
residues of certain pesticide chemicals in or on various food
commodities under section 408 of the Federal Food, Drug, and Comestic
Act (FFDCA), 21 U.S.C. 346a. EPA has determined that these petitions
contain data or information regarding the elements set forth in section
408(d)(2); however, EPA has not fully evaluated the sufficiency of the
submitted data at this time or whether the data supports granting of
the petition. Additional data may be needed before EPA rules on the
petition.
The official record for this notice of filing, as well as the
public version, has been established for this notice of filing under
docket control number PF-745 (including comments and data submitted
electronically as described below). 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 official record is located at the address in
``ADDRESSES'' at the beginning of this document.
Electronic comments can 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. Comment and data
will also be accepted on disks in Wordperfect 5.1 file format or ASCII
file format. All comments and data in electronic form must be
identified by the docket control number PF-745 and appropriate petition
number. Electronic comments on this notice may be filed online at many
Federal Depository Libraries.
List of Subjects
Environmental protection, Agricultural commodities, Food additives,
Feed additives, Pesticides and pests, Reporting and recordkeeping
requirements.
Dated: June 13, 1997.
James Jones,
Acting Director, Registration Division, Office of Pesticide Programs.
Summaries of Petitions
Petitioner summaries of the pesticide petitions are printed below
as required by section 408(d)(3) of the FFDCA. The summaries of the
petitions were prepared by the petitioners and represent the views of
the petitioners. EPA is publishing the petition summaries verbatim
without editing them in any way. The petition summary announces the
availability of a description of the analytical methods available to
EPA for the detection and measurement of the pesticide chemical
residues or an explanation of why no such method is needed.
Monsanto Company
PP 6F4620
EPA has received a pesticide petition (PP 6F4620) from the Monsanto
Company, 700 14th St., NW., Suite 1100, Washington, DC 20005 pursuant
to section 408(d) of FFDCA, as amended, 21 U.S.C. 346a(d), by the Food
Quality Protection Act of 1996 (Pub. L. 104-170, 110 Stat. 1489)
proposing to amend 40 CFR 180.479 by establishing tolerance for
residues of the herbicide, halosulfuron-methyl: (methyl 5-[(4,6-
dimethoxy-2-pyrimidinyl)amino] carbon-ylaminosul-fonyl-3-chloro-1-
methyl-1H-pyrazole-4-carbo-xylate), in or on the raw agricultural
commodity sugarcane, cane at 0.05 ppm. EPA has determined that the
petition contains data or information regarding the elements set forth
in section 408(d)(2); however, EPA has not fully evaluated the
sufficieny of the submitted data at this time or whether the data
supports granting of the petition. Additional data may be needed before
EPA rules on the petition.
The proposed analytical method for determining residues is by gas
chromatography with an electron-capture detection.
The following is a summary of the information submitted to EPA to
support the establishment, under section 408(b)(2)(D) of the amended
FFDCA, of a tolerance for halosulfuron-methyl in sugarcane.
Halosulfuron-methyl is a selective herbicide for the control of annual
broadleaf weeds and nutsedge in field corn, milo, turf,
[[Page 33865]]
sugarcane, sweet corn/popcorn and other crops which is effective at low
use rates. It may be applied pre-emergent, pre-plant incorporated, or
postemergent in field corn. Single or sequential postemergence
application rates are effective in milo, turf, and sugarcane.
A. Plant Metabolism and Analytical Method
The metabolism of halosulfuron-methyl as well as the nature of the
residues is adequately understood for purposes of the tolerances.
Metabolism depends on the mode of application. Preemergent applications
result in rapid soil degradation of halosulfuron-methyl followed by
crop uptake of the resulting pyrazole moiety. The pyrimidine ring binds
tightly to soil and is eventually converted to carbon dioxide by
microbial degradation. In postemergent applications, little metabolism
and translocation take place resulting in unmetabolized parent compound
as the major residue on the directly treated foliar surfaces. Very low
levels of residues are found in the grain. In the sugarcane residue
study, no residues at or above the limit of quantitation of 0.05 parts
per million (ppm) were observed even from samples obtained when the
exaggerated rate (>10x) was applied.
An adequate analytical method, gas chromatography with an electron-
capture detector, is available for enforcement purposes with a limit of
detection that allows monitoring of food with residues at or above the
levels set in these tolerances. The field corn and grain sorghum (milo)
enforcement methodology has been submitted to the Food and Drug
Administration for publication in the Pesticide Analytical Manual, Vol.
II (PAM II). This method underwent independent laboratory validation
and validation at the Beltsville laboratory. The Analytical Chemistry
section of the EPA concluded that the method is adequate for
enforcement. Analytical method is also available for analyzing meat by-
products which also underwent successful independent laboratory and
Beltsville laboratory validations.
B. Toxicological Profile of Halosulfuron-methyl
The toxicological data has been deemed complete by EPA. Data
considered in support of the tolerance include:
1. Acute toxicological studies placing the technical-grade
halosulfuron in Toxicity Category III.
2. A 90-day feeding study in rats resulted in a lowest-observed-
effect-level (LOEL) of 497 milligrams/kilograms/day (mg/kg/day) in
males and 640 mg/kg/day in females, and a no-observed-effect-level
(NOEL) of 116 mg/kg/day in males and 147 mg/kg/day in females.
3. A 21-day dermal toxicity study in rats resulted in a NOEL of 100
mg/kg/day in males and greater than 1,000 mg/kg/day in females. The
only treatment-related effect was a decrease in body weight gain of the
1,000 mg/kg/day group in males.
4. A 1-year chronic oral study in dogs resulted in a LOEL of 40
mg/kg/day based on decreased weight gain and a NOEL of 10 mg/kg/day for
systemic toxicity.
5. A 78-week carcinogenicity study was performed on mice. Males in
the 971.6 mg/kg/day group had decreased body weight gains and an
increased incidence of microconcretion/mineralization in the testis and
epididymis. No treatment-related effects were noted in females. Based
on these results, a LOEL of 971.9 mg/kg/day was established in males
and NOEL's of 410 mg/kg/day in males and 1,214.6 mg/kg/day in females
were established. The study showed no evidence of carcinogenicity.
6. A combined chronic toxicity/carcinogenicity study in rats
resulted in a LOEL of 225.2 mg/kg/day in males and 138.6 mg/kg/day in
females based on decreased body weight gains, and a NOEL of 108.3 mg/
kg/day in males and 56.3 mg/kg/day in females. The study showed no
evidence of carcinogenicity.
7. A developmental toxicity study in rats resulted in a
developmental LOEL of 750 mg/kg/day, based on decreases in mean litter
size and fetal body weight, and increases in resorptions, resorptions/
dam, post-implantation loss and in fetal and litter incidences of soft
tissue and skeletal variations, and a developmental NOEL of 250 mg/kg/
day. Maternal LOEL was 750 mg/kg/day based on increased incidence of
clinical observations, reduced body weight gains, and reduced food
consumption and food efficiency. The maternal NOEL was 250 mg/kg/day.
8. A developmental toxicity study in rabbits resulted in a
developmental LOEL of 150 mg/kg/day, based on decreased mean litter
size and increases in resorptions, resorptions/dam and post-
implantation loss, and a developmental NOEL of 50 mg/kg/day. The
maternal LOEL was 150 mg/kg/day based on reduced body weight gain and
reduced food consumption and food efficiency. The maternal NOEL was 50
mg/kg/day.
9. A dietary two-generation reproduction study in rats resulted in
parental toxicity at 223.2 mg/kg/day in males and 261.4 mg/kg/day in
females in the form of decreased body weights, decreased body weight
gains, and reduced food consumption during the premating period. Very
slight effects were noted in body weight of the offspring at this dose.
This effect was considered to be developmental toxicity (developmental
delay) rather than a reproductive effect. No effects were noted on
reproductive or other developmental toxicity parameters. The systemic/
developmental toxicity LOEL was 223.2 mg/kg/day in males and 261.4 mg/
kg/day in females; the systemic/developmental toxicity NOEL was 50.4
mg/kg/day in males and 58.7 mg/kg/day in females. The reproductive LOEL
was greater than 223.2 mg/kg/day in males and 261.4 mg/kg/day in
females; the reproductive NOEL was equal to or greater than 223.2 mg/
kg/day in males and 261.4 mg/kg/day in females.
10. Bacterial/mammalian microsomal mutagenicity assays were
performed and found not to be mutagenic.
11. Two mutagenicity studies were performed to test gene mutation
and found to produce no chromosomal aberrations or gene mutations in
cultured Chinese hamster ovary cells.
12. An in vivo mouse micronucleus assay did not cause a significant
increase in the frequency of micronucleated polychromatic erythrocytes
in bone marrow cells.
13. A mutagenicity study was performed on rats and found not to
induce unscheduled DNA synthesis in primary rat hepatocytes.
14. A metabolism study in rats resulted in the administered dose
being absorbed rapidly and incompletely. Most of the test article was
eliminated by urine and feces within 72 hours, and appeared to be
independent of dose and sex.
Threshold Effects
Chronic effects. Based on the complete and reliable toxicity data
base, EPA has adopted a Reference Dose (RfD) value of 0.1 mg/kg body
weight/day based on a NOEL of 10.0 mg/kg body weight/day from a one-
year dog feeding study and an uncertainty factor of 100. EPA has
concluded that the toxicity of the metabolite is lower compared to the
parent compound and is not a residue of concern (see metabolite
toxicity section below).
Acute effects. EPA has determined that the appropriate NOEL to use
to assess safety in acute exposure is 50 mg/kg body weight/day from a
developmental toxicity study in rabbits. EPA has concluded that the
subpopulation of concern for this endpoint are females older than 13
years old.
Non-threshold Effects
[[Page 33866]]
Carcinogenicity. EPA's Office of Pesticide Programs' Health Effects
Division's Carcinogenicity Peer Review Committee (CPRC) has classified
halosulfuron-methyl in Group E (evidence of noncarcinogenicity for
humans) under the Agency's ``Guidelines for Carcinogen Risk
Assessment'' published in the Federal Register of September 24, 1986
(51 FR 33992). In its evaluation, CPRC gave consideration to body
weight gain changes and changes in hematological and blood chemistry
parameters in the 1-year feeding study in dogs. Hence, there are no
non-threshold effects associated with the compound and cancer risk
assessment is not appropriate.
Metabolite toxicity. The following toxicology studies were
conducted with the metabolite, 3-chloro-1-methyl-5-sulfamoylpyrazole-4-
carboxylic acid (3-CSA). Based on the toxicological data of the 3-CSA
metabolite, EPA has concluded that it appears to be of lower toxicity
compared to the parent compound and that it should not be included in
the tolerance expression. The residue of concern is the parent compound
only.
(1) A 90-day rat feeding study resulted in a LOEL in males of
>20,000 ppm and a NOEL of 20,000 ppm (1,400 mg/kg/day). In
females, the LEL is 10,000 ppm (772.8 mg/kg/day) based on decreased
body weight gains and a NOEL of 1,000 ppm (75.8 mg/kg/day).
(2) A developmental toxicity resulted in a LOEL for maternal
toxicity of >1,000 mg/kg/day based on the absence of systemic toxicity,
a NOEL of 1,000 mg/kg/day. The developmental LOEL is >1,000
mg/kg/day and the NOEL is 1,000 mg/kg/day.
(3) The microbial reverse gene mutation did not produce any
mutagenic effect while the mammalian cell gene mutation/chinese hamster
ovary cells showed no clear evidence of mutagenic effect in the Chinese
hamster ovary cells.
(4) The mouse micronucleus assay did not show any clastogenic or
aneugenic effect.
C. Aggregate Exposure
1. Dietary exposure. For purposes of assessing the potential
dietary exposure from food under the proposed tolerances, Monsanto has
estimated aggregate exposure based on the Theoretical Maximum Residue
Contribution (TMRC) from established tolerances, viz.; tolerances in or
on the following raw agricultural commodities, field corn, grain at 0.1
ppm; field corn, forage at 0.3 ppm; field corn, fodder at 1.5 ppm;
grain sorghum (milo) grain at 0.1 ppm; grain sorghum (milo) forage at
0.1 ppm; grain sorghum (milo) fodder/stover at 0.1 ppm; and meat and
meat byproducts (cattle, goats, hogs, horses, and sheep) at 0.1 ppm as
well as proposed tolerances, viz.; on sugarcane and sweet corn/popcorn
(included in another submission under PP 6F4661). Field corn forage and
fodder as well as sorghum forage and fodder/stover are fed to animals,
thus exposure of humans to residues from these commodities might result
if such residues are transferred to meat, milk, poultry, or eggs.
However, based on the results of a animal metabolism study and the
amount of halosulfuron-methyl expected in animal feed, Monsanto has
concluded that there is no reasonable expectation that residues of
halosulfuron-methyl will exceed existing tolerances in meat. EPA has
concluded that regulation of animal commodities and poultry products
are not required.
TMRC is obtained by multiplying the tolerance levels for each
commodity by consumption data which estimates the amount of crops and
related food stuff consumed by the U.S. population and various
population subgroups. In conducting this exposure assessment, Monsanto
has made very conservative assumptions, e.g., 100% of all commodities
will contain halosulfuron-methyl residues and those residues would be
at the level of their respective tolerances. This results in a large
overestimate of human exposure. Even with these conservative
assumptions, the potential dietary exposure to halosulfuron from
consumption of products for which it is currently labeled and proposed
represents only 0.6% of the RfD for the general population.
2. Dietary (drinking water) exposure. There is no Maximum
Contaminant Level (MCL) established for residues of halosulfuron-methyl
nor is it listed for MCL development or monitoring in drinking water
supplies under the Safe Drinking Water Act. It is not a target of EPA's
National Survey of Wells for Pesticides. Monsanto is not aware of
halosulfuron-methyl being detected in any wells, ponds, lakes, streams,
etc. from its use in the United States. A Lifetime Health Advisory
Level (HAL) calculated by EPA procedures may be used as a preliminary
acceptable level in drinking water. The calculated level is 700 ppb
assuming a 20% relative contribution from water which is high enough to
provide ample margin of safety. In addition, EPA has concluded that
potential levels of halosulfuron-methyl in soil and water do not appear
to have toxicological effects on humans or animals. No effects were
observed on a variety of animals at concentrations several orders of
magnitude greater than would likely occur in soil, ground water, or
surface water.
Based on the very low level of mammalian toxicity, lack of other
toxicological concerns coupled with low use rates, Monsanto believes
that there is reasonable certainty that no harm will result from
dietary exposure to halosulfuron-methyl since dietary exposure to
residues on food will use only a small fraction of the RfD and any
contribution through drinking water is expected to be insignificant.
3. Non-dietary exposure. Halosulfuron-methyl is labeled for use on
commercial and residential turf and other non-crop sites which could
have minimal opportunity for exposure. The other uses which are
agricultural including the proposed uses (sugarcane and sweet corn/
popcorn) will not increase the non-occupational exposure appreciably,
if at all. Any exposure to halosulfuron-methyl resulting from turf use
will result from dermal exposure during application and will be limited
because of low use rates. In the 21-day dermal study, no treatment
related adverse effects were observed and the NOAEL was determined to
be greater than the highest dose level tested, 1000 mg/kg.
Halosulfuron-methyl is non-volatile with a vapor pressure of <1 x="" 10-7="" mm="" hg,="" hence,="" inhalation="" exposure="" during="" and="" after="" application="" will="" not="" add="" significantly="" to="" aggregate="" exposure.="" based="" on="" the="" physical="" and="" chemical="" characteristics,="" low="" use="" rates,="" low="" acute="" toxicity="" and="" lack="" of="" other="" toxicological="" concerns,="" monsanto="" believes="" that="" the="" risk="" posed="" by="" non-occupational="" exposure="" to="" halosulfuron-methyl="" is="" minimal.="" d.="" cumulative="" effect="" halosulfuron-methyl="" belongs="" to="" the="" sulfonyl="" urea="" class="" of="" compounds.="" the="" mode="" of="" action="" of="" halosulfuron-methyl="" is="" the="" inhibition="" of="" the="" plant="" enzyme="" aceto="" lactase="" synthetase,="" which="" is="" essential="" for="" the="" production="" of="" required="" amino="" acid="" in="" the="" plant.="" although="" other="" registered="" sulfonyl="" ureas="" may="" have="" similar="" herbicidal="" mode="" of="" action,="" there="" is="" no="" information="" available="" to="" suggest="" that="" these="" compounds="" exhibit="" a="" similar="" toxicity="" profile="" in="" the="" mammalian="" system="" that="" would="" be="" cumulative="" with="" halosulfuron-methyl.="" thus,="" consideration="" of="" a="" common="" mechanism="" of="" toxicity="" is="" not="" appropriate="" at="" this="" time.="" monsanto="" is="" considering="" only="" the="" potential="" risks="" of="" halosulfuron-methyl="" in="" its="" aggregate="" exposure="" assessment.="" [[page="" 33867]]="" e.="" determination="" of="" safety="" for="" u.s.="" population="" 1.="" chronic="" dietary="" exposure.="" the="" agency="" has="" concluded="" that="" the="" aggregate="" exposure="" to="" halosulfuron-methyl="" from="" the="" previously="" established="" tolerances="" is="" 0.00051="" mg/kg="" of="" body="" weight/day="" for="" the="" general="" population="" utilizing="" 0.051%="" of="" the="" rfd.="" the="" exposure="" contribution="" from="" the="" proposed="" uses="" in="" sugarcane="" and="" sweetcorn/popcorn="" when="" combined="" with="" exposure="" from="" established="" tolerances="" is="" calculated="" to="" be="" 0.6%="" of="" the="" rfd="" over="" all="" u.s.="" population="" and="" considered="" to="" be="" minimal.="" epa="" generally="" has="" no="" concern="" for="" exposures="" below="" 100="" percent="" of="" the="" rfd="" for="" the="" u.s.="" population="" 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.="" toxicology="" data="" indicating="" low="" potential="" for="" mammalian="" toxicity="" and="" lack="" of="" other="" toxicity="" concerns="" plus="" the="" conservative="" assumptions="" used="" here="" support="" the="" conclusion="" that="" there="" is="" a="" ``reasonable="" certainty="" of="" no="" harm''="" from="" aggregate="" exposure="" to="" halosulfuron-methyl="" residues="" from="" all="" anticipated="" dietary="" exposures="" and="" all="" other="" non-occupational="" exposures.="" 2.="" acute="" dietary="" exposure.="" the="" detailed="" dres="" acute="" exposure="" analysis="" conducted="" by="" epa="" evaluates="" individual="" food="" consumption="" as="" reported="" by="" respondents="" in="" the="" usda="" 77-78="" nationwide="" food="" consumption="" survey="" (nfcs)="" and="" estimates="" the="" distribution="" of="" single="" day="" exposures="" through="" the="" diet="" for="" the="" us="" population="" and="" certain="" subgroups.="" since="" the="" toxicological="" effect="" to="" which="" high="" end="" exposure="" is="" compared="" is="" developmental="" toxicity,="" epa="" determined="" that="" the="" dres="" subgroup="" of="" concern="" is="" females="" (13+="" years)="" which="" approximates="" women="" of="" child-="" bearing="" age.="" the="" margin="" of="" exposure="" (moe)="" is="" a="" measure="" of="" how="" closely="" the="" high="" end="" exposure="" comes="" to="" the="" noel,="" and="" is="" calculated="" as="" the="" ratio="" of="" the="" noel="" to="" the="" exposure="" (noel/exposure="MOE)." for="" toxicological="" endpoints="" established="" based="" upon="" animal="" studies,="" the="" agency="" is="" generally="" not="" concerned="" unless="" the="" moe="" is="" below="" 100.="" in="" this="" analysis,="" epa="" used="" tolerance="" level="" residues="" to="" calculate="" the="" exposure="" of="" the="" highest="" exposed="" individual="" (females,="" 13+="" year="" subgroup).="" high="" end="" exposure="" for="" this="" subgroup="" resulted="" in="" an="" moe="" in="" excess="" of="" 30,000.="" epa="" concluded="" that="" acute="" dietary="" exposure="" to="" halosulfuron-methyl="" does="" not="" represent="" a="" risk="" concern.="" monsanto's="" calculation="" of="" the="" moe="" which="" included="" proposed="" tolerances="" for="" sugarcane="" and="" sweet="" corn/popcorn="" was="" 24,732.="" f.="" safety="" determination="" for="" infants="" and="" children="" in="" assessing="" the="" potential="" for="" additional="" sensitivity="" of="" infants="" and="" children="" to="" residues="" of="" halosulfuron-methyl,="" monsanto="" considered="" data="" from="" developmental="" toxicity="" studies="" in="" the="" rat="" and="" rabbit="" and="" a="" 2-="" generation="" reproduction="" study="" in="" the="" rat.="" the="" developmental="" toxicity="" studies="" are="" designed="" to="" evaluate="" the="" potential="" for="" adverse="" effects="" on="" the="" developing="" organism="" resulting="" from="" exposure="" during="" prenatal="" development="" to="" the="" female="" parent.="" reproduction="" studies="" provide="" information="" relating="" to="" effects="" from="" exposure="" to="" the="" chemical="" on="" the="" reproductive="" capability="" of="" both="" (mating)="" parents="" and="" on="" systemic="" toxicity.="" in="" a="" developmental="" toxicity="" study="" in="" the="" rat,="" the="" noel="" for="" both="" maternal="" and="" developmental="" toxicity="" was="" considered="" to="" be="" 250="" mg/kg/day.="" in="" a="" developmental="" toxicity="" study="" in="" rabbits,="" a="" noel="" for="" both="" developmental="" and="" maternal="" toxicity="" was="" considered="" to="" be="" 50="" mg/kg/day.="" a="" dietary="" two-generation="" reproduction="" study="" in="" rats="" resulted="" in="" parental="" toxicity="" at="" 223.2="" mg/kg/day="" in="" males="" and="" 261.4="" mg/kg/day="" in="" females="" in="" the="" form="" of="" decreased="" body="" weights,="" decreased="" body="" weight="" gains,="" and="" reduced="" food="" consumption="" during="" the="" premating="" period.="" very="" slight="" effects="" were="" noted="" in="" body="" weight="" of="" the="" offspring="" at="" this="" dose.="" this="" effect="" was="" considered="" to="" be="" developmental="" toxicity="" (developmental="" delay)="" rather="" than="" a="" reproductive="" effect.="" no="" effects="" were="" noted="" on="" reproductive="" or="" other="" developmental="" toxicity="" parameters.="" the="" systemic/="" developmental="" toxicity="" noel="" was="" 50.4="" mg/kg/day="" in="" males="" and="" 58.7="" mg/kg/="" day="" in="" females.="" the="" reproductive="" noel="" was="" equal="" to="" or="" greater="" than="" 223.2="" mg/kg/day="" in="" males="" and="" 261.4="" mg/kg/day="" in="" females.="" in="" all="" cases,="" the="" reproductive="" and="" developmental="" noels="" were="" greater="" than="" the="" noel="" on="" which="" the="" rfd="" was="" based,="" thus="" allowing="" for="" an="" additional="" margin="" of="" safety="" and="" indicating="" that="" halosulfuron-methyl="" does="" not="" pose="" any="" increased="" risk="" to="" infants="" or="" children.="" chronic="" analysis.="" using="" the="" conservative="" dietary="" exposure="" assumptions="" described="" above,="" epa="" has="" established="" that="" the="" tmrc="" for="" the="" most="" exposed="" subgroups="" is="" 0.0012="" mg/kg="" body="" weight/day="" for="" nonnursing="" infants="" (less="" than="" 1="" year="" old)="" and="" 0.0010="" mg/kg="" body="" weight/day="" for="" children="" (1="" to="" 6="" years="" old),="" and="" that="" this="" aggregate="" exposure="" to="" residues="" of="" halosulfuron-methyl="" utilizes="" only="" 1.17="" and="" 1.01="" percent="" of="" the="" rfd,="" respectively="" when="" existing="" tolerances="" are="" considered.="" monsanto's="" analysis="" included="" contribution="" from="" sugarcane="" and="" sweet="" corn/popcorn="" exposures="" and="" the="" additional="" amount="" of="" the="" rfd="" utilized="" was="" minimal="" (1.7="" and="" 1.3%),="" respectively.="" ffdca="" section="" 408="" provides="" that="" epa="" may="" apply="" an="" additional="" safety="" factor="" (up="" to="" 10)="" in="" the="" case="" of="" threshold="" effects="" for="" infants="" and="" children="" to="" account="" for="" pre-="" and="" post-natal="" toxicity="" and="" the="" completeness="" of="" the="" data="" base.="" based="" on="" current="" toxicological="" data="" requirements,="" the="" data="" base="" relative="" to="" preand="" post-natal="" effects="" in="" children="" is="" complete.="" further,="" the="" noel="" of="" 10="" mg/kg/day="" from="" the="" 1-year="" feeding="" study="" in="" dogs,="" which="" was="" used="" to="" calculate="" the="" rfd="" (discussed="" above),="" is="" already="" lower="" than="" the="" noels="" from="" the="" reproductive="" and="" developmental="" studies="" with="" halosulfuron-methyl="" by="" a="" factor="" of="" at="" least="" 25-="" and="" 5-fold,="" respectively.="" therefore,="" an="" additional="" safety="" factor="" is="" not="" warranted="" and="" an="" rfd="" of="" 0.1="" mg/kg/day="" is="" appropriate="" for="" assessing="" aggregate="" risk="" to="" infants="" and="" children.="" therefore,="" based="" on="" complete="" and="" reliable="" toxicity="" data="" and="" the="" conservative="" exposure="" assessment,="" monsanto="" concludes="" that="" there="" is="" reasonable="" certainty="" that="" no="" harm="" will="" result="" to="" infants="" and="" children="" from="" aggregate="" exposure="" to="" halosulfuron-methyl="" residues.="" g.="" estrogenic="" effects="" no="" specific="" tests="" have="" been="" conducted="" with="" halosulfuron-methyl="" to="" determine="" whether="" the="" chemical="" may="" have="" an="" effect="" in="" humans="" that="" is="" similar="" to="" an="" effect="" produced="" by="" a="" naturally="" occuring="" estrogen="" or="" other="" endocrine="" effects.="" however,="" there="" were="" no="" significant="" findings="" in="" other="" relevant="" toxicity="" tests,="" i.e.,="" teratology="" and="" multi-generation="" reproduction="" studies,="" which="" would="" suggest="" that="" halosulfuron-methyl="" produces="" effects="" characteristic="" of="" the="" disruption="" of="" the="" estrogenic="" hormone.="" h.="" international="" tolerances="" maximum="" residue="" levels="" have="" not="" been="" established="" for="" residues="" of="" halosulfuron-methyl="" on="" corn,="" sorghum,="" sugarcane="" or="" sweet="" corn="" or="" any="" other="" food="" or="" feed="" crop="" by="" the="" codex="" alimentarius="" commission.="" pp="" 6f4661="" epa="" has="" received="" a="" pesticide="" petition="" (pp="" 6f4661)="" from="" the="" monsanto="" company,="" 700="" 14th="" st.,="" nw.,="" suite="" 1100,="" washington,="" dc="" 20005="" pursuant="" to="" section="" 408(d)="" of="" ffdca,="" as="" amended,="" 21="" u.s.c.="" 346a(d),="" by="" fqpa="" (pub.="" l.="" 104-170,="" 110="" stat.="" 1489)="" proposing="" to="" amend="" 40="" cfr="" part="" 180.479="" by="" establishing="" tolerance="" for="" residues="" of="" the="" herbicide,="" halosulfuron-="" [[page="" 33868]]="" methyl:="" (methyl="" 5-[(4,6-dimethoxy-2-pyrimidinyl)amino]="" carbon-="" ylaminosulfonyl-3-chloro-1-methyl-1h-pyrazole-4-carboxylate),="" in="" or="" on="" the="" raw="" agricultural="" commodity="" sweet="" corn,="" sweet="" corn="" (kernel="" plus="" cobs="" with="" husks="" removed)="" at="" 0.1="" ppm,="" sweet="" corn="" forage="" at="" 0.5="" ppm="" and="" sweet="" corn="" fodder/stover="" at="" 1.5="" ppm="" and="" pop="" corn="" grain="" at="" 0.1="" ppm="" and="" pop="" corn="" stover/fodder="" at="" 1.5="" ppm.="" epa="" has="" determined="" that="" the="" petition="" contains="" data="" or="" information="" regarding="" the="" elements="" set="" forth="" in="" section="" 408(d)(2);="" however,="" epa="" has="" not="" fully="" evaluated="" the="" sufficieny="" of="" the="" submitted="" data="" at="" this="" time="" or="" whether="" the="" data="" supports="" granting="" of="" the="" petition.="" additional="" data="" may="" be="" needed="" before="" epa="" rules="" on="" the="" petition.="" the="" proposed="" analytical="" method="" for="" determining="" residues="" is="" by="" gas="" chromatography="" with="" an="" electron-capture="" detection.="" epa,="" as="" mentioned="" above,="" is="" in="" the="" process="" of="" evaluating="" the="" petition.="" with="" one="" exception,="" the="" summary="" for="" pp="" 6f4661="" is="" identical="" to="" the="" summary="" of="" pp="" 6f4620="" as="" outlined="" above,="" therefore="" it="" is="" not="" restated.="" with="" regards="" to="" the="" exception,="" the="" sugarcane="" residues="" study="" discussed="" in="" the="" first="" paragraph,="" last="" sentence="" of="" unit="" a="" of="" the="" pp="" 6f4620="" summary="" was="" not="" included="" in="" the="" pp="" 6f4661="" summary.="" [fr="" doc.="" 97-16355="" filed="" 6-20-97;="" 8:45="" am]="" billing="" code="" 6560-50-f="">