[Federal Register Volume 64, Number 193 (Wednesday, October 6, 1999)]
[Notices]
[Pages 54300-54303]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-26079]
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ENVIRONMENTAL PROTECTION AGENCY
[PF-835; FRL-6029-9]
American Cyanamid Company; Pesticide Tolerance Petition Filing
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces the initial filing of a pesticide
petition proposing the establishment of regulations for residues of a
certain pesticide chemical in or on various food commodities.
DATES: Comments, identified by the docket control number PF-835, must
be received on or before November 5, 1999.
ADDRESSES: By mail submit written comments to: Information and Records
Integrity Branch, Public Information and Services Divison (7502C),
Office of Pesticides Programs, Environmental Protection Agency, 401 M
St., SW., Washington, DC 20460. In person bring comments to: Rm. 119,
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. 119 at the
address given above, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays.
FOR FURTHER INFORMATION CONTACT: Marion M. Johnson, Registration
Division (7505W), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW, Washington, DC 20460. Office
location, telephone number, and e-mail address: Rm. 208, Crystal Mall
#2 , 1921 Jefferson Davis Highway, Arlington, VA 22202, (703) 305-6701;
e-mail:johnson.marion @epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA has received a pesticide petition as
follows proposing the establishment and/or amendment of regulations for
residues of certain pesticide chemical 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 this petition
contains 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-835] (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 5.1/6.1 file format or
ASCII file format. All comments and data in electronic form must be
identified by the docket control number (PF-835) 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: September 28, 1999.
James Jones,
Director, Registration Division, Office of Pesticide Programs.
Summary of Petition
The petitioner summary of the pesticide petition is printed below
as required by section 408(d)(3) of the FFDCA. The summary of the
petition was prepared by the petitioner and represents the views of the
petitioner.
[[Page 54301]]
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.
American Cyanamid Company
PP 2F2609
EPA has received a pesticide petition (PP 2F2609) from American
Cyanamid Company, P. O. Box 400, Princeton, NJ 08543-0400, proposing
pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act,
21 U.S.C. 346a(d), to amend 40 CFR part 180 by establishing a tolerance
for residues of tetrahydro-5,5-dimethyl-2(1H)-pyrimidinone[3-{4-
(trifluoromethyl)phenyl]-1-[2-[4-(trifluoromethyl)phenyl]ethenyl]-2-
propenylidene]hydrazone, hydramethylnon] in or on the raw agricultural
commodity [pineapples] at 0.05 parts per million (ppm). EPA has
determined that the petition contains data or information regarding the
elements set forth in section 408(d)(2) of the FFDCA; 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.
A. Residue Chemistry
1. Plant metabolism. Metabolism studies were conducted on grass and
pineapples utilizing two distinct 14C-radiolabeled forms of
hydramethylnon. Based on these studies, the qualitative nature of the
residues of hydramethylnon in plants is understood and the parent
molecule is considered to be the only residue of concern.
2. Analytical method. Adequate enforcement methodology is available
in PAM II (Method I) to enforce the tolerance expression. A
confirmatory method has recently been submitted to the FDA for
inclusion in PAM II.
3. Magnitude of residue. Based on the results of seven pineapple
field trials, including two studies conducted at 5x the maximum
application rate, residues of hydramethylnon are not expected to exceed
0.05 ppm in/on pineapples. Processing studies have demonstrated that
residues are not expected to concentrate in pineapple processed
commodities. The Agency has previously established a time-limited
tolerance at this level to cover residues that may occur as a result of
use under section 18 emergency authorizations issued to the State of
Hawaii. Secondary residues of hydramethylnon are not expected in animal
commodities and no tolerances for secondary residues of hydramethylnon
in livestock commodities are currently established.
B. Toxicological Profile
1. Acute toxicity. Based on the results of the acute toxicity data,
hydramethylnon does not exhibit significant acute toxicity. For the
acute oral study in rats, the LD50 in males was 817
milligram/kilogram (mg/kg) and the LD50 in females was 1,502
mg/kg. The LD50 for the acute dermal study in rabbits was
greater than 2,000 mg/kg and the 4-hour LC50 for acute
inhalation in rats was 2.9 mg/l (males and females combined).
Hydramethylnon is not a dermal irritant or a skin sensitizer and is a
mild eye irritant.
2. Genotoxicty. The following genotoxicity tests were all negative:
Salmonella typhimurium/Escherichia coli reverse gene mutation assay,
Schizosaccharomyces pombe P1 forward gene mutation assay, in vitro
Chinese Hamster Ovary (CHO) chromosome aberration, Saccharomyces
cerevisiae D4 mitotic gene conversion assay. The data suggest that
hydramethylnon is not genotoxic in microbial test systems or
clastogenic in cultured mammalian cells and does not induce dominant
lethality in male rat germinal cells. The evidence of male infertility
and testicular atrophy at 90 milligram/kilogram/day (mg/kg/day in the
dominant lethal assay is consistent with similar findings observed in
the chronic rat study, the 18-month mouse feeding study, the 2-
generation reproduction study, and the 91 day oral gavage study in
dogs.
3. Reproductive and developmental toxicity. There is no evidence in
the prenatal developmental toxicity studies in either rats or rabbits
of alterations to CNS development, nor is there any indication of
neurotoxicity in the other short or long-term oral studies in rats,
mice or dogs. No evidence of the increased sensitivity of the
developing offspring was noted as the No Observed Effect Levels (NOELs)
for developmental toxicity in the rat (10 milligram/kilogram/body
weight/day (mg/kg/bwt/day) and the rabbit (5 mg/kg/bwt/day) were
greater than the NOELs for maternal toxicity (3 mg/kg/bwt/day for the
rat and < 5="" (mg/kg/bwt/day="" for="" the="" rabbit).="" hydramethylnon="" is="" not="" teratogenic="" in="" either="" the="" rat="" or="" rabbit.="" hydramethylnon="" is="" a="" male="" reproductive="" toxicant="" which="" appears="" to="" specifically="" target="" the="" germinal="" cells="" and/or="" tissues="" in="" the="" testes.="" in="" a="" 2-generation="" rat="" reproduction="" study,="" there="" was="" no="" evidence="" of="" systemic="" toxicity,="" nor="" was="" there="" any="" evidence="" of="" direct="" toxicity="" in="" the="" offspring.="" the="" reproductive="" noel="" was="" 25="" ppm="" (1.66="" mg/kg/day="" for="" males)="" and="" the="" lowest="" observed="" adverse="" effect="" level="" (loael)="" was="" 50="" ppm="" (3.32="" mg/kg/day="" for="" males),="" based="" upon="" histopathological="" findings="" in="" the="" testes="" and="" the="" epididymides.="" also="" at="" 75="" ppm="" (5.05="" mg/kg/day="" in="" males),="" reproductive="" performance="" of="" the="" males="" was="" decreased="" with="" longer="" precoital="" intervals,="" lower="" pregnancy="" rates,="" reduced="" gestation="" weight="" gain="" for="" females="" and="" smaller="" litters.="" 4.="" subchronic="" toxicity.="" the="" following="" are="" the="" results="" of="" the="" subchronic="" toxicity="" tests="" that="" have="" been="" conducted="" with="" hydramethylnon:="" 91="" day="" feeding="" study="" in="" rats="" (noel="" 2.5="" mg/kg/bwt/day);="" 91="" day="" gavage="" study="" in="" dogs="" (noel="">< 3="" mg/kg/bwt/day);="" 21="" day="" dermal="" study="" in="" rabbits="" (noel="" 250="" mg/kg/="" bwt/day).="" for="" both="" the="" short-="" and="" intermediate-term="" margin="" of="" exposure="" (moe)="" calculations,="" the="" agency's="" hazard="" identification="" committee="" recommended="" use="" of="" the="" systemic="" noel="" (freestanding)="" of="" 250="" mg/kg/day="" from="" the="" 21="" day="" dermal="" toxicity="" study="" in="" new="" zealand="" white="" rabbits.="" non-adverse="" signs="" at="" the="" noel="" included="" decreased="" food="" consumption="" in="" males="" and="" females,="" and="" thrombocytopenia="" in="" females.="" 5.="" chronic="" toxicity.="" the="" epa="" has="" established="" the="" reference="" dose="" (rfd)="" for="" hydramethylnon="" at="" 0.01="" mg/kg/day.="" this="" rfd="" is="" based="" on="" a="" 6-="" month="" feeding="" study="" in="" dogs="" with="" a="" noel="" of="" 1.0="" mg/kg/day="" based="" on="" an="" increased="" incidence="" of="" soft="" stools,="" mucoid="" stools,="" and="" diarrhea="" at="" the="" loael="" of="" 3.0="" mg/kg/day.="" an="" uncertainty="" factor="" of="" 100="" was="" used="" during="" calculation="" of="" the="" rfd.="" based="" on="" a="" statistically="" significant="" increase="" in="" lung="" adenomas="" and="" combined="" lung="" adenomas/carcinomas="" in="" female="" mice,="" hydramethylnon="" has="" been="" classified="" as="" a="" group="" c="" chemical="" (possible="" human="" carcinogen)="" by="" the="" agency's="" cancer="" peer="" review="" committee.="" the="" committee="" recommended="" using="" the="" rfd="" approach="" for="" risk="" assessment.="" 6.="" animal="" metabolism.="" adequate="" rat="" and="" goat="" metabolism="" studies="" are="" available="" for="" hydramethylnon.="" results="" of="" ruminant="" metabolism="" and="" feeding="" studies="" clearly="" demonstrate="" that="" there="" is="" no="" reasonable="" expectation="" that="" residues="" of="" hydramethylnon="" in="" pineapple="" processed="" commodities="" will="" be="" transferred="" to="" milk="" or="" edible="" tissues.="" hence,="" no="" tolerances="" on="" any="" food="" items="" derived="" from="" ruminants="" are="" required="" for="" hydramethylnon.="" 7.="" metabolite="" toxicology.="" the="" parent="" molecule="" is="" the="" only="" moiety="" of="" toxicological="" significance="" which="" needs="" regulation="" in="" plant="" commodities.="" [[page="" 54302]]="" 8.="" 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.="" at="" the="" present="" time,="" no="" reliable="" information="" is="" available="" to="" indicate="" that="" hydramethylnon="" has="" a="" potential="" to="" have="" an="" effect="" in="" humans="" that="" is="" similar="" to="" effects="" produced="" by="" naturally="" occurring="" estrogen="" or="" other="" endocrine="" substances.="" c.="" aggregate="" exposure="" 1.="" dietary="" exposure.="" a="" 0.05="" ppm="" tolerance="" for="" the="" residues="" of="" hydramethylnon="" has="" only="" been="" established="" for="" grasses="" and="" as="" there="" is="" no="" reasonable="" expectation="" that="" residues="" in="" grass="" will="" be="" transferred="" to="" the="" milk="" and="" edible="" tissues="" of="" ruminants,="" no="" tolerances="" for="" hydramethylnon="" have="" been="" established="" on="" any="" food="" items.="" thus,="" there="" is="" no="" contribution="" to="" the="" aggregate="" exposure="" of="" hydramethylnon="" residues="" from="" dietary="" sources.="" therefore,="" the="" following="" risk="" assessment="" to="" assess="" dietary="" exposures="" and="" risks="" from="" hydramethylnon="" will="" be="" based="" on="" dietary="" exposures="" resulting="" from="" only="" the="" pending="" tolerance="" in/on="" pineapples.="" 2.="" acute="" exposure="" and="" risk--i.="" food.="" 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="" 1-day="" or="" single="" exposure.="" the="" acute="" dietary="" (food="" only)="" risk="" assessment="" is="" not="" required="" as="" the="" agency's="" hazard="" identification="" committee="" did="" not="" identify="" any="" acute="" dietary="" risk="" endpoints.="" ii.="" chronic="" exposure="" and="" risk.="" in="" response="" to="" epa's="" granting="" of="" an="" emergency="" exemption="" under="" fifra="" section="" 18="" authorizing="" the="" use="" of="" hydramethylnon="" in="" pineapples="" in="" hawaii,="" a="" time-limited="" tolerance="" of="" 0.05="" ppm="" was="" established="" in/on="" pineapple="" fruits.="" the="" agency="" has="" conducted="" a="" chronic="" dietary="" risk="" assessment="" based="" on="" very="" conservative="" assumptions="" --="" 100%="" of="" pineapple="" commodities="" will="" contain="" hydramethylnon="" residues="" and="" those="" residues="" will="" be="" at="" the="" level="" of="" the="" required="" tolerance="" --="" which="" results="" in="" an="" overestimate="" of="" human="" dietary="" exposure.="" thus,="" in="" making="" a="" safety="" determination="" for="" this="" time-limited="" tolerance,="" hed="" has="" taken="" into="" account="" this="" conservative="" exposure="" assessment.="" based="" on="" similar="" considerations,="" the="" pending="" hydramethylnon="" tolerance="" in/on="" pineapples="" results="" in="" a="" tmrc="" that="" is="" equivalent="" to="" the="" following="" percentages="" of="" the="" rfd="" of="" 0.01="" mg/kg/day:="" ------------------------------------------------------------------------="" population="" subgroup="" %="" rfd="" ------------------------------------------------------------------------="" u.s.="" population.....................=""><0.1% nursing="" infants.....................=""><0.1% non-nursing="" infants=""><1-year old)...="" 0.2%="" children="" (1-6="" years="" old)............="" 0.1%="" children="" (7-12="" years="" old)...........=""><0.1% ------------------------------------------------------------------------="" the="" subgroups="" listed="" above="" are:="" (1)="" the="" u.s.="" population="" (48="" states);="" (2)="" those="" for="" infants="" and="" children;="" and,="" (3)="" the="" other="" subgroups="" for="" which="" the="" percentage="" of="" the="" rfd="" occupied="" is="" greater="" than="" that="" occupied="" by="" the="" subgroup="" u.s.="" population="" (48="" states).="" 3.="" drinking="" water.="" based="" on="" its="" physical="" and="" chemical="" properties,="" (extremely="" low="" water="" solubility="" of="" 7-9="" ppb="" at="" 25="" deg.c="" and="" rapid="" aqueous="" photolysis="" with="" a="" \1/2\="" of="" less="" than="" 1="" hour),="" there="" is="" no="" concern="" for="" exposure="" to="" residues="" of="" hydramethylnon="" in="" potable="" water.="" hydramethylnon="" is="" also="" immobile="" in="" soil="" and="" does="" not="" leach="" because="" it="" is="" strongly="" adsorbed="" to="" all="" common="" soil="" types;="" thus="" hydramethylnon="" and="" its="" degradates="" are="" not="" expected="" to="" leach="" to="" groundwater.="" there="" are="" no="" established="" maximum="" contaminant="" levels="" (mcls)="" for="" residues="" of="" hydramethylnon="" in="" drinking="" water="" and="" no="" health="" advisory="" levels="" for="" this="" active="" ingredient="" in="" drinking="" water="" have="" been="" issued.="" because="" the="" agency="" lacks="" sufficient="" water-related="" exposure="" data="" to="" complete="" a="" comprehensive="" drinking="" water="" risk="" assessment="" for="" many="" pesticides,="" epa="" has="" commenced="" and="" nearly="" completed="" a="" process="" to="" identify="" a="" reasonable="" yet="" conservative="" bounding="" figure="" for="" the="" potential="" contribution="" of="" water-related="" exposure="" to="" the="" aggregate="" risk="" posed="" by="" a="" pesticide.="" in="" developing="" the="" bounding="" figure,="" epa="" estimated="" residue="" levels="" in="" water="" for="" a="" number="" of="" specific="" pesticides="" using="" various="" data="" sources.="" the="" agency="" then="" applied="" the="" estimated="" residue="" levels,="" in="" conjunction="" with="" appropriate="" toxicological="" endpoints="" (rfd's="" or="" acute="" dietary="" noel's)="" and="" assumptions="" about="" body="" weight="" and="" consumption,="" to="" calculate,="" for="" each="" pesticide,="" the="" increment="" of="" aggregate="" risk="" contributed="" by="" consumption="" of="" contaminated="" water.="" while="" epa="" has="" not="" yet="" pinpointed="" the="" appropriate="" bounding="" figure="" for="" exposure="" from="" contaminated="" water,="" the="" ranges="" the="" agency="" is="" continuing="" to="" examine="" are="" all="" below="" the="" level="" that="" would="" cause="" hydramethylnon="" to="" exceed="" the="" rfd="" if="" the="" tolerance="" being="" considered="" in="" this="" document="" were="" granted.="" the="" potential="" exposures="" associated="" with="" hydramethylnon="" in="" water,="" even="" at="" the="" higher="" levels="" the="" agency="" is="" considering="" as="" a="" conservative="" upper="" bound,="" would="" be="" negligible="" and="" there="" is="" a="" reasonable="" certainty="" of="" no="" harm="" if="" the="" pending="" tolerance="" is="" granted.="" 4.="" non-dietary="" exposure.="" hydramethylnon="" is="" currently="" registered="" for="" use="" on="" the="" following="" residential="" non-food="" sites:="" recreational="" areas,="" ornamental="" plants,="" lawns,="" turf,="" and="" household="" or="" domestic="" dwellings.="" however="" as="" the="" vapor="" pressure="" of="" hydramethylnon="" is="" less="" than="" 2="" x="">-8 mm of Hg at 35 and 45 deg.C, the potential for non-
occupational exposure by inhalation is insignificant. Moreover, based
on the current and proposed use patterns, chronic exposure is not
likely. Although there may be short- and intermediate-term non-
occupational dermal exposure scenarios, dermal absorption studies
conducted with the 2% gel formulation indicate that less than 1% of the
dose is dermally absorbed after 10-hours. In addition, the Agency has
reviewed risk assessments and accepted the existence of more than
adequate margins of exposure ((MOE) of 658 for both commercial and
homeowner applicators and MOEs of >540 for post-application homeowner
exposures) for other hydramethylnon-based products, containing up to 2%
active ingredient. Thus, this new use pattern does not present any
incremental risk of exposure to hydramethylnon residues.
[[Page 54303]]
D. Cumulative Effects
To the best of our knowledge, hydramethylnon is the only registered
pesticide which belongs to a unique chemical class, the pyrimidinones
(amidinohydrazones). Unlike other pesticides for which EPA has followed
a cumulative risk approach based on a common mechanism of toxicity,
hydramethylnon does not appear to produce a toxic metabolite produced
by other substances. Therefore, the potential for cumulative effects of
hydramethylnon and other chemicals having a common mechanism of
toxicity should not be of concern and for the purposes of this
tolerance action, it is assumed that hydramethylnon does not have a
common mechanism of toxicity with other substances.
E. Safety Determination
1. U.S. population--i. Acute risk. An acute endpoint has not been
identified. The Agency's Hazard Identification Committee determined
that this risk assessment is not required.
ii. Chronic risk. Using the TMRC exposure assumptions described
above, EPA has concluded that aggregate exposure to hydramethylnon from
food will utilize <1% of="" the="" rfd="" of="" 0.01="" mg/kg/day="" for="" the="" u.s.="" population.="" 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.="" in="" view="" of="" the="" negligible="" potential="" for="" exposure="" to="" hydramethylnon="" in="" drinking="" water="" and="" from="" non-dietary,="" non-="" occupational="" exposure,="" the="" aggregate="" exposure="" is="" not="" expected="" to="" exceed="" 100%="" of="" the="" rfd.="" epa="" has="" concluded="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" from="" aggregate="" exposure="" to="" hydramethylnon="" residues.="" according="" to="" agency="" policy,="" the="" residential="" uses="" of="" hydramethylnon="" do="" not="" fall="" under="" a="" chronic="" exposure="" scenario.="" thus,="" it="" can="" be="" concluded="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" from="" chronic="" aggregate="" exposure="" to="" hydramethylnon="" residues.="" iii.="" short-="" and="" intermediate-term="" risk.="" short-="" and="" intermediate-="" term="" aggregate="" exposure="" takes="" into="" account="" chronic="" dietary="" food="" and="" water="" (considered="" to="" be="" a="" background="" exposure="" level)="" plus="" indoor="" and="" outdoor="" residential="" exposure.="" although="" hydramethylnon="" has="" residential="" uses,="" this="" new="" use="" pattern="" does="" not="" present="" any="" incremental="" risk="" of="" exposure="" to="" hydramethylnon="" residues.="" as="" discussed="" previously="" in="" section="" c.="" 4.,="" the="" vapor="" pressure="" of="" hydramethylnon="" is="" less="" than="" 2="" x="">-8 mm of Hg at 35 and 45 deg.C; thus, the potential for
non-occupational exposure by inhalation is insignificant. Moreover,
based on the physical and chemical properties of hydramethylnon,
exposure from drinking water is not likely. Although there may be
short- and intermediate-term occupational and non-occupational dermal
exposures, the Agency has reviewed risk assessments and accepted the
existence of more than adequate margins of exposure (MOE of 658 for
both commercial and homeowner applicators and MOEs of >540 for post-
application homeowner exposures) for other hydramethylnon-based
products, containing up to 2% active ingredient. Thus, as in the case
for chronic exposure scenarios, it can be concluded that there is a
reasonable certainty that no harm will result from short and
intermediate-term exposures to hydramethylnon residues.
2. Infants and children-i. Chronic risk. Using the TMRC exposure
assumptions described above, EPA has concluded that aggregate exposure
to hydramethylnon from food will utilize only 0.2% of the RfD of 0.01
mg/kg/day for non-nursing infants <1-year old.="" ii.="" safety="" factor="" for="" infants="" and="" children-in="" general.="" in="" assessing="" the="" potential="" for="" additional="" sensitivity="" of="" infants="" and="" children="" to="" residues="" of="" hydramethylnon,="" epa="" considered="" data="" from="" developmental="" toxicity="" studies="" in="" the="" rat="" and="" rabbit="" and="" a="" 2-generation="" reproduction="" study="" in="" the="" rat..="" epa="" has="" concluded="" that="" the="" toxicological="" database="" for="" hydramethylnon="" is="" adequate="" and="" does="" not="" indicate="" an="" increased="" sensitivity="" of="" perinatal="" animals="" to="" pre-="" and/or="" post="" natal="" exposures.="" therefore,="" no="" additional="" uncertainty="" factor="" for="" protection="" of="" infants="" and="" children="" are="" warranted="" for="" hydramethylnon.="" iii.="" developmental="" toxicity="" studies.="" in="" the="" rat="" developmental="" toxicity="" study,="" the="" developmental="" noel="" was="" 10="" mg/kg="" b.w./day="" with="" a="" noel="" for="" maternal="" toxicity="" of="" 3.0="" mg/kg/bwt/day.="" in="" the="" rabbit="" developmental="" toxicity="" study="" the="" developmental="" noel="" was="" 5="" mg/kg/bwt/day="" with="" a="" noel="" for="" maternal="" toxicity="" of="" less="" than="" 5="" mg/kg/bwt/day.="" iv.="" reproductive="" toxicity="" study.="" a="" 2-generation="" reproduction="" study="" with="" hydramethylnon="" was="" conducted="" in="" rats.="" the="" data="" support="" a="" noel="" for="" reproductive="" toxicity="" of="" 50="" ppm="" (4.2="" mg/kg/bwt/day),="" while="" the="" noel="" for="" paternal="" toxicity="" was="" 25="" ppm="" (2.1="" mg/kg/bwt/day).="" no="" adverse="" effects="" were="" observed="" in="" the="" pups.="" these="" values="" are="" significantly="" higher="" than="" the="" noel="" used="" to="" calculate="" the="" rfd="" for="" the="" general="" u.s.="" population="" which="" is="" 0.01="" mg/kg/="" bwt/day.="" these="" results="" demonstrate="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" to="" infants="" or="" children="" from="" aggregate="" exposure="" to="" hydramethylnon.="" f.="" international="" tolerances="" there="" are="" no="" codex,="" canadian="" or="" mexican="" residue="" limits="" established="" for="" hydramethylnon="" in/on="" pineapple.="" thus,="" harmonization="" is="" not="" an="" issue="" for="" this="" petition.="" [fr="" doc.="" 99-26079="" filed="" 10-5-98;="" 8:45="" am]="" billing="" code="" 6560-50-f="">