[Federal Register Volume 64, Number 12 (Wednesday, January 20, 1999)]
[Notices]
[Pages 3099-3102]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-1120]
[[Page 3099]]
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ENVIRONMENTAL PROTECTION AGENCY
[PF-852; FRL-6053-5]
Notice of Filing of a Pesticide Petition
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
certain pesticide chemicals in or on various food commodities.
DATES: Comments, identified by the docket control number PF-852, must
be received on or before February 19, 1999.
ADDRESSES: By mail submit written comments to: Public Information and
Records Integrity Branch (7502C), Information Resources and Services
Division, 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 to: docket@epamail.epa.gov. Follow 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: By mail: James 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: Rm. 239, CM #2, 1921
Jefferson Davis Hwy., Arlington, VA 22202, (703)-305-5697; e-mail:
tompkins.jim@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 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 the 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-852] (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 or ASCII file
format. All comments and data in electronic form must be identified by
the docket control number [PF-852] 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: December 23, 1998.
James Jones,
Director, Registration Division, Office of Pesticide Programs.
Summary of Petition
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 view of the
petitioner. EPA is publishing the petition summary verbatim without
editing it 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.
Zeneca Ag. Products
PP 5F4554
EPA has received a pesticide petition (PP 5F4554) from Zeneca Ag.
Products, 1800 Concord Pike, P. O. Box 15458, Wilmington, DE 19850-
5458, 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 sulfosate (the
trimethylsulfonium salt of glyphosate, also known as glyphosate-
trimesium in or on the raw agricultural commodity (RAC) wheat bran at
2.5 parts per million (ppm) (of which no more than 0.75 ppm is
trimethylsulfonium (TMS)), wheat grain at 0.75 ppm (of which no more
than 0.25 ppm is TMS), wheat forage at 35 ppm (of which no more than 30
ppm is TMS), wheat hay at 85 ppm (of which no more than 80 ppm is TMS),
wheat shorts at 1.5 ppm (of which no more than 0.5 ppm is TMS), wheat
straw at 1.0 ppm (of which no more than 0.5 ppm is TMS), the pome fruit
group at 0.05 ppm; in cattle, goat, hog, sheep, and horse liver at 0.5
ppm, in cattle, goat, hog, sheep, and horse meat by-products, except
liver at 2.5 ppm; to increase the tolerance in cattle, goat, hog,
sheep, and horse meat from 0.2 to 0.4 ppm and in milk from 0.2 to 0.5
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. The metabolism of sulfosate has been studied
in corn, grapes, and soybeans. EPA has concluded that the nature of the
residue is adequately understood and that the residues of concern are
the parentions only N-(phosphonomethyl)-glycine anion (PMG) and
trimethylsulfonium cation (TMS).
2. Analytical method. Gas chromatography/mass selective detector
methods have been developed for PMG analysis in crops, animal tissues,
milk, and eggs. Gas chromatography detection
[[Page 3100]]
methods have been developed for TMS in crops, animal tissues, milk, and
eggs.
3. Magnitude of residues in crops-- i. Wheat. A total of 15 field
residue trials were conducted in 14 different states accounting for 77%
of the total U.S. wheat acreage. These trials were located in Regions 2
(1 trial), 4 (1 trial), 5 (6 trials), 8 (3 trials), 10 (1 trial) and 11
(3 trials). Applications in the trials were consistent with the
requested label directions for use. Analysis of the treated samples
showed that the maximum PMG residue was 1.47 ppm in forage, 0.34 ppm in
grain, and 0.38 ppm in straw. The maximum TMS residue was 25.1 ppm in
forage, 0.21 ppm in grain and 0.4 ppm in straw. Residue data are not
available for wheat hay, but can be estimated using the forage residue
data and a dry-down factor of 3.
Wheat grain for processing was obtained and samples were processed
into bran, middlings, shorts, flour and aspirated grain fractions.
Analysis of the treated samples showed that residue of both TMS and PMG
concentrated in bran and shorts. The appropriate concentration factors
for bran are 3.1x (PMG), and 2.1x (TMS); and for shorts are 2.0x (PMG),
and 1.8x (TMS). The residues in the wheat aspirated grain fraction are
less than the tolerance already established for aspirated grain
fractions, so no tolerance action is required.
ii. Pome fruit group. A total of 15 field residue trials (nine
apple and six pear) were conducted in seven different States,
accounting for 78 and 99% of the total U.S. apple, and pear production,
respectively. Harvested fruit had residues of PMG and TMS that were
<0.05 ppm="" in="" all="" samples.="" the="" residue="" data="" support="" the="" proposed="" tolerance="" of="" 0.05="" ppm="" for="" pome="" fruit.="" apples="" were="" processed="" from="" a="" trial="" treated="" at="" an="" exagerrated="" rate.="" the="" samples="" were="" processed="" into="" wet="" pomace,="" dry="" pomace="" and="" juice.="" analysis="" of="" the="" treated="" samples="" showed="" that="" residues="" of="" both="" tms="" and="" pmg="" were=""><0.05 ppm="" in="" the="" rac="" and="" all="" processed="" fractions.="" no="" tolerance="" action="" for="" apple="" processed="" products="" is="" required.="" 4.="" magnitude="" of="" residue="" in="" animals--="" i.="" ruminants.="" the="" maximum="" dietary="" burden="" in="" dairy="" cows="" results="" from="" a="" diet="" comprised="" of="" 20%="" aspirated="" grain="" fractions,="" 60%="" wheat="" forage,="" and="" 20%="" soybean="" seed/meal="" for="" a="" total="" dietary="" burden="" of="" 134="" ppm.="" the="" maximum="" dietary="" burden="" in="" beef="" cows="" results="" from="" a="" diet="" comprised="" of="" 20%="" aspirated="" grain="" fractions,="" 25%="" wheat="" forage,="" 25%="" wheat="" hay,="" 10%="" wheat="" straw,="" and="" 20%="" soybean="" seed/meal="" for="" a="" total="" dietary="" burden="" of="" 122="" ppm.="" comparison="" to="" a="" ruminant="" feeding="" study="" at="" a="" dosing="" level="" of="" 300="" ppm="" indicates="" that="" the="" appropriate="" tolerance="" levels="" would="" be="" 0.5="" ppm="" in="" cattle,="" goat,="" hog,="" sheep,="" and="" horse="" liver;="" 2.5ppm="" in="" cattle,="" goat,="" hog,="" sheep,="" and="" horse="" meat="" by-products,="" except="" liver;="" 0.4="" ppm="" in="" cattle,="" goat,="" hog,="" sheep,="" and="" horse="" meat;="" 0.5="" ppm="" in="" milk;="" and="" 0.1="" ppm="" in="" cattle,="" goat,="" hog,="" sheep,="" and="" horse="" fat.="" all="" of="" these="" tolerances="" exceed="" existing="" tolerances="" in="" 40="" cfr="" 180.489,="" except="" fat.="" ii.="" poultry.="" the="" maximum="" poultry="" dietary="" burden="" results="" from="" a="" diet="" comprised="" of="" 80%="" wheat="" grain="" and="" 20%="" wheat="" milled="" by-products="" for="" a="" total="" dietary="" burden="" of="" 1.5="" ppm.="" comparison="" to="" a="" poultry="" feeding="" study="" at="" a="" dosing="" level="" of="" 5="" ppm="" indicates="" that="" the="" appropriate="" tolerance="" levels="" would="" be="" below="" the="" established="" tolerances="" for="" poultry="" meat,="" meat="" by-products,="" fat,="" and="" eggs.="" b.="" toxicological="" profile="" 1.="" acute="" toxicity.="" several="" acute="" toxicology="" studies="" have="" been="" conducted="" placing="" technical="" grade="" sulfosate="" in="" toxicity="" category="" iii="" and="" iv.="" 2.="" genotoxicity.="" mutagenicity="" data="" includes="" two="" ames="" tests="" with="" salmonella="" typhimurium;="" a="" sex="" linked="" recessive="" lethal="" test="" with="" drosophila="" melanoga;="" a="" forward="" mutation="" (mouse="" lymphoma)="" test;="" an="" in="" vivo="" bone="" marrow="" cytogenetics="" test="" in="" rats;="" a="" micronucleus="" assay="" in="" mice;="" an="" in="" vitro="" chromosomal="" aberration="" test="" in="" chinese="" hamster="" ovary="" cells="" (cho)="" (no="" aberrations="" were="" observed="" either="" with="" or="" without="" s9="" activation="" and="" there="" were="" no="" increases="" in="" sister="" chromatid="" exchanges);="" and="" a="" morphological="" transformation="" test="" in="" mice="" (all="" negative).="" a="" chronic="" feeding/carcinogenicity="" study="" was="" conducted="" in="" male="" and="" female="" rats="" fed="" dose="" levels="" of="" 0,="" 100,="" 500="" and="" 1,000="" ppm="" (0,="" 4.20,="" 21.2="" or="" 41.8="" milligram/kilogram/day="" (mg/kg/day)="" in="" males="" and="" 0,="" 5.4,="" 27.0="" or="" 55.7="" mg/kg/day="" in="" females).="" no="" carcinogenic="" effects="" were="" observed="" under="" the="" conditions="" of="" the="" study.="" the="" systemic="" no-observed="" adverse="" effect="" level="" (noael)="" of="" 1,000="" ppm="" (41.1/55.7="" mg/kg/day="" for="" males="" and="" females,="" respectively)="" was="" based="" on="" decreased="" body="" weight="" gains="" (considered="" secondary="" to="" reduced="" food="" consumption)="" and="" increased="" incidences="" of="" chronic="" laryngeal="" and="" nasopharyngeal="" inflammation="" (males).="" a="" chronic="" feeding/carcinogenicity="" study="" was="" conducted="" in="" male="" and="" female="" mice="" fed="" dosage="" levels="" of="" 0,="" 100,="" 1,000,="" and="" 8,000="" ppm="" (0,="" 11.7,="" 118="" or="" 991="" mg/="" kg/day="" in="" males="" and="" 0,="" 16,="" 159="" or="" 1,341="" mg/kg/day="" in="" females).="" no="" carcinogenic="" effects="" were="" observed="" under="" the="" conditions="" of="" the="" study="" at="" dose="" levels="" up="" to="" and="" including="" the="" 8,000="" ppm="" highest="" dose="" tested="" (hdt)="" may="" have="" been="" excessive).="" the="" systemic="" noael="" was="" 1,000="" ppm="" based="" on="" decreases="" in="" body="" weight="" and="" feed="" consumption="" (both="" sexes)="" and="" increased="" incidences="" of="" duodenal="" epithelial="" hyperplasia="" (females="" only).="" sulfosate="" is="" classified="" as="" a="" group="" e="" carcinogen="" based="" on="" no="" evidence="" of="" carcinogenicity="" in="" rat,="" and="" mouse="" studies.="" 3.="" reproductive="" and="" developmental="" toxicity.="" a="" developmental="" toxicity="" study="" in="" rats="" was="" conducted="" at="" doses="" of="" 0,="" 30,="" 100="" and="" 333="" mg/="" kg/day.="" the="" maternal="" (systemic)="" noael="" was="" 100="" mg/kg/day,="" based="" on="" decreased="" body="" weight="" gain="" and="" food="" consumption,="" and="" clinical="" signs="" (salivation,="" chromorhinorrhea,="" and="" lethargy)="" seen="" at="" 333="" mg/kg/day.="" the="" reproductive="" noael="" was="" 100="" mg/kg/day,="" based="" on="" decreased="" mean="" pup="" weight.="" the="" decreased="" pup="" weight="" is="" a="" direct="" result="" of="" the="" maternal="" toxicity.="" a="" developmental="" toxicity="" study="" was="" conducted="" in="" rabbits="" at="" doses="" of="" 0,="" 10,="" 40="" and="" 100="" mg/kg/day="" with="" developmental="" and="" maternal="" toxicity="" noaels="" of="" 40="" mg/kg/day="" based="" on="" the="" following:="" (i)="" maternal="" effects:="" 6="" of="" 17="" dams="" died="" (2="" of="" the="" 4="" non-gravid="" dams);="" 4="" of="" 11="" dams="" aborted;="" clinical="" signs="" -="" higher="" incidence="" and="" earlier="" onset="" of="" diarrhea,="" anorexia,="" decreased="" body="" weight="" gain="" and="" food="" consumption;="" and="" (ii)="" fetal="" effects:="" decreased="" litter="" sizes="" due="" to="" increased="" post-="" implantation="" loss,="" seen="" at="" 100="" mg/kg/day="" hdt.="" the="" fetal="" effects="" were="" clearly="" a="" result="" of="" significant="" maternal="" toxicity.="" a="" 2-generation="" reproduction="" study="" in="" rats="" fed="" dosage="" rates="" of="" 0,="" 150,="" 800="" and="" 2,000="" ppm="" (equivalent="" to="" calculated="" doses="" of="" 0,="" 7.5,="" 40,="" and="" 100="" mg/kg/day="" for="" males="" and="" females,="" based="" on="" a="" factor="" of="" 20).="" the="" maternal="" (systemic)="" noael="" was="" 150="" ppm="" (7.5="" mg/kg/day),="" based="" on="" decreases="" in="" body="" weight="" and="" body="" weight="" gains="" accompanied="" by="" decreased="" food="" consumption,="" and="" reduced="" absolute="" and="" sometimes="" relative="" organ="" (thymus,="" heart,="" kidney="" &="" liver)="" weights="" seen="" at="" 800="" and="" 2,000="" ppm="" (40="" and="" 100="" mg/kg/day).="" the="" reproductive="" noael="" was="" 150="" ppm="" (7.5="" mg/kg/day),="" based="" on="" decreased="" mean="" pup="" weights="" during="" lactation="" (after="" day="" 7)="" in="" the="" second="" litters="" at="" 800="" ppm="" (40="" mg/kg/day)="" and="" in="" all="" litters="" at="" 2,000="" ppm="" (100="" mg/kg/day),="" and="" decreased="" litter="" size="" in="" the="" f0a="" and="" f1b="" litters="" at="" 2,000="" ppm="" (100="" mg/kg/day).="" the="" statistically="" significant="" decreases="" in="" pup="" weights="" at="" the="" 800="" ppm="" level="" were="" borderline="" biologically="" significant="" because="" at="" no="" time="" were="" either="" the="" body="" weights="" or="" body="" weight="" gains="" less="" than="" 90%="" of="" the="" control="" values="" and="" because="" the="" effect="" was="" not="" [[page="" 3101]]="" apparent="" in="" all="" litters.="" both="" the="" slight="" reductions="" in="" litter="" size="" at="" 2,000="" ppm="" and="" the="" reductions="" in="" pup="" weights="" at="" 800="" and="" 2,000="" ppm="" appear="" to="" be="" secondary="" to="" the="" health="" of="" the="" dams.="" there="" was="" no="" evidence="" of="" altered="" intrauterine="" development,="" increased="" stillborns,="" or="" pup="" anomalies.="" the="" effects="" are="" a="" result="" of="" feed="" palatability="" leading="" to="" reduced="" food="" consumption="" and="" decreases="" in="" body="" weight="" gains="" in="" the="" dams.="" 4.="" subchronic="" toxicity.="" two="" subchronic="" 90="" day="" feeding="" studies="" with="" dogs="" and="" a="" 1-year="" feeding="" study="" in="" dogs="" have="" been="" conducted.="" in="" the="" 1-="" year="" study="" dogs="" were="" fed="" 0,="" 2,="" 10="" or="" 50="" mg/kg/day.="" the="" noael="" was="" determined="" to="" be="" 10="" mg/kg/day="" based="" on="" decreases="" in="" lactate="" dehydrogenase="" (ldh)="" at="" 50="" mg/kg/day.="" in="" the="" first="" 90="" day="" study,="" dogs="" were="" fed="" dosage="" levels="" of="" 0,="" 2,="" 10="" and="" 50="" mg/kg/day.="" the="" noael="" in="" this="" study="" was="" 10="" mg/kg/day="" based="" on="" transient="" salivation,="" and="" increased="" frequency="" and="" earlier="" onset="" of="" emesis="" in="" both="" sexes="" at="" 50="" mg/kg/day.="" a="" second="" 90="" day="" feeding="" study="" with="" dogs="" dosed="" at="" 0,="" 10,="" 25="" and="" 50="" mg/kg/="" day="" was="" conducted="" to="" refine="" the="" threshold="" of="" effects.="" there="" was="" evidence="" of="" toxicity="" at="" the="" top="" dose="" of="" 50="" mg/kg/day="" with="" a="" noael="" of="" 25="" mg/kg/day.="" adverse="" effects="" from="" oral="" exposure="" to="" sulfosate="" occur="" at="" or="" above="" 50="" mg/kg/day.="" these="" effects="" consist="" primarily="" of="" transient="" salivation,="" which="" is="" regarded="" as="" a="" pharmacological="" rather="" than="" toxicological="" effect,="" emesis="" and="" non-biologically="" significant="" hematological="" changes.="" exposures="" at="" or="" below="" 25="" mg/kg/day="" have="" not="" resulted="" in="" significant="" biological="" adverse="" effects.="" in="" addition,="" a="" comparison="" of="" data="" from="" the="" 90="" day="" and="" 1-year="" studies="" indicates="" that="" there="" is="" no="" evidence="" for="" increased="" toxicity="" with="" time.="" the="" overall="" noael="" in="" the="" dog="" is="" 25="" mg/kg/day.="" 5.="" chronic="" toxicity.="" a="" chronic="" feeding/carcinogenicity="" study="" was="" conducted="" in="" male="" and="" female="" rats="" fed="" dose="" levels="" of="" 0,="" 100,="" 500="" and="" 1,000="" ppm="" (0,="" 4.20,="" 21.2="" or="" 41.8="" mg/kg/day="" in="" males,="" and="" 0,="" 5.4,="" 27.0="" or="" 55.7="" mg/kg="" day="" in="" females).="" no="" carcinogenic="" effects="" were="" observed="" under="" the="" conditions="" of="" the="" study.="" the="" systemic="" noael="" of="" 1,000="" ppm="" (41.1/55.7="" mg/kg/day="" for="" males,="" and="" females,="" respectively)="" was="" based="" on="" decreased="" body="" weight="" gains="" (considered="" secondary="" to="" reduced="" food="" consumption)="" and="" increased="" incidences="" of="" chronic="" laryngeal="" and="" nasopharyngeal="" inflammation="" (males).="" a="" chronic="" feeding/carcinogenicity="" study="" was="" conducted="" in="" male="" and="" female="" mice="" fed="" dosage="" levels="" of="" 0,="" 100,="" 1,000="" and="" 8,000="" ppm="" (0,="" 11.7,="" 118="" or="" 991="" mg/kg/day="" in="" males="" and="" 0,="" 16,159="" or="" 1,341="" mg/kg/day="" in="" females).="" no="" carcinogenic="" effects="" were="" observed="" under="" the="" conditions="" of="" the="" study="" at="" dose="" levels="" up="" to="" and="" including="" the="" 8,000="" ppm="" (hdt="" may="" have="" been="" excessive).="" the="" systemic="" noael="" was="" 1,000="" ppm="" based="" on="" decreases="" in="" body="" weight="" and="" feed="" consumption="" (both="" sexes)="" and="" increased="" incidences="" of="" duodenal="" epithelial="" hyperplasia="" (females="" only).="" sulfosate="" is="" classified="" as="" a="" group="" e="" carcinogen="" based="" on="" no="" evidence="" of="" carcinogenicity="" in="" rat="" and="" mouse="" studies.="" 6.="" animal="" metabolism.="" the="" metabolism="" of="" sulfosate="" has="" been="" studied="" in="" animals.="" the="" residues="" of="" concern="" for="" sulfosate="" in="" meat,="" milk,="" and="" eggs="" are="" the="" parent="" ions="" pmg="" and="" tms="" only.="" 7.="" metabolite="" toxicology.="" there="" are="" no="" metabolites="" of="" toxicological="" concern.="" only="" the="" parent="" ions,="" pmg="" and="" tms="" are="" of="" toxicological="" concern.="" 8.="" endocrine="" disruption.="" current="" data="" suggest="" that="" sulfosate="" is="" not="" an="" endocrine="" disruptor.="" c.="" aggregate="" exposure="" 1.="" dietary="" exposure--="" i.food.="" for="" the="" purposes="" of="" assessing="" the="" potential="" dietary="" exposure,="" zeneca="" has="" utilized="" the="" tolerance="" level="" for="" all="" existing="" and="" pending="" tolerances;="" and="" the="" proposed="" maximum="" permissible="" levels="" of="" 0.75="" ppm="" for="" wheat="" grain;="" 2.5="" ppm="" for="" wheat="" bran;="" 1.5="" ppm="" for="" wheat="" shorts;="" 0.05="" ppm="" for="" the="" pome="" fruit="" group;="" 0.5="" ppm="" for="" cattle,="" goat,="" hog,="" sheep,="" and="" horse="" liver;="" 2.5="" ppm="" for="" cattle,="" goat,="" hog,="" sheep,="" and="" horse="" meat="" by-products,="" except="" liver;="" 0.4="" ppm="" for="" cattle,="" goat,="" hog,="" sheep,="" and="" horse="" meat;="" 0.5="" ppm="" in="" milk,="" and="" 100%="" crop="" treated="" acreage="" for="" all="" commodities.="" assuming="" that="" 100%="" of="" foods,="" meat,="" eggs,="" and="" milk="" products="" will="" contain="" sulfosate="" residues="" and="" those="" residues="" will="" be="" at="" the="" level="" of="" the="" tolerance="" results="" in="" an="" over="" estimate="" of="" human="" exposure.="" this="" is="" a="" very="" conservative="" approach="" to="" exposure="" assessment.="" ii.="" chronic="" exposure.="" for="" all="" existing="" tolerances="" and="" pending="" tolerances;="" and="" the="" proposed="" maximum="" permissible="" levels="" proposed="" in="" this="" notice="" of="" filing,="" the="" potential="" exposure="" for="" the="" u.s.="" population="" is="" 0.018="" milligram/kilogram="" body="" weight/day="" (mg/kg/bwt/day)="" (7.4%="" of="" reference="" dose="" (rfd)).="" potential="" exposure="" for="" children's="" population="" subgroups="" range="" from="" 0.015="" mg/kg="" bwt/day="" (6.1%="" of="" rfd)="" for="" nursing="" infants=""><1 year="" old)="" to="" 0.076="" mg/kg="" bwt/day="" (30.5%)="" for="" non-nursing="" infants.="" the="" chronic="" dietary="" risk="" due="" to="" food="" does="" not="" exceed="" the="" level="" of="" concern="" (100%).="" iii.="" acute="" exposure.="" the="" exposure="" to="" the="" most="" sensitive="" population="" subgroup,="" in="" this="" instance="" non-nursing="" infants,="" was="" 23.2%="" of="" the="" acute="" rfd.="" the="" acute="" dietary="" risk="" due="" to="" food="" does="" not="" exceed="" the="" level="" of="" concern="" (100%).="" 2.="" drinking="" water.="" results="" from="" computer="" modeling="" indicate="" that="" sulfosate="" in="" groundwater="" will="" not="" contribute="" significant="" residues="" in="" drinking="" water="" as="" a="" result="" of="" sulfosate="" use="" at="" the="" recommended="" maximum="" annual="" application="" rate="" (4.00="" lbs.="" a.i.="" acre="">-1). The
computer model uses conservative numbers, therefore it is unlikely that
groundwater concentrations would exceed the estimated concentration of
0.00224 parts per billion (ppb), and sulfosate should not pose a threat
to ground water.
The surface water estimates are based on an exposure modeling
procedure called GENEEC (Generic Expected Environmental Concentration).
The assumptions of 1 application of 4.00 lbs. a.i. acre -1
resulted in calculated estimated maximum concentrations of 64 ppb
(acute, based on the highest 56 day value) and 43 ppb (chronic,
average). GENEEC modeling procedures assumed that sulfosate was applied
to a 10-hectare field that drained into a 1-hectare pond, 2-meters deep
with no outlet.
As a conservative assumption, because sulfosate residues in ground
water are expected to be insignificant compared to surface water, it
has been assumed that 100% of drinking water consumed was derived from
surface water in all drinking water exposure and risk calculations.
To calculate the maximum acceptable acute and chronic exposures to
sulfosate in drinking water, the dietary food exposure (acute or
chronic) was subtracted from the appropriate (acute or chronic) RfD.
DWLOCs were then calculated using the maximum acceptable acute or
chronic exposure, default body weights (70 kg - adult, 10 kg - child),
and drinking water consumption figures (2 liters - adult, 1 liter -
child).
The maximum concentration of sulfosate in surface water is 64 ppb.
The acute DWLOCs for sulfosate in surface water were all greater than
7700 ppb. The estimated average concentration of sulfosate in surface
water is 43 ppb which is much less than the calculated levels of
concern (>1,700) in drinking water as a contribution to chronic
aggregate exposure. Therefore, for current and proposed uses of
sulfosate, Zeneca concludes with reasonable certainty that residues of
sulfosate in drinking water would not result in unacceptable levels of
aggregate human health risk.
3. Non-dietary exposure. Sulfosate is currently not registered for
use on any residential non-food sites. Therefore,
[[Page 3102]]
residential exposure to sulfosate residues will be through dietary
exposure only.
D. Cumulative Effects
There is no information to indicate that toxic effects produced by
sulfosate are cumulative with those of any other chemical compound.
E. Safety Determination
1. U.S. population-- i. Acute risk. Since there are no residential
uses for sulfosate, the acute aggregate exposure only includes food and
water. Using the conservative assumptions of 100% of all crops treated
and assuming all residues are at the tolerance level for all
established and proposed tolerances, the aggregate exposure to
sulfosate will utilize 17.3% of the acute RfD for the US population.
The estimated peak concentrations of sulfosate in surface and ground
water are less than DWLOCs for sulfosate in drinking water as a
contribution to acute aggregate exposure. Residues of sulfosate in
drinking water do not contribute significantly to the aggregate acute
human health risk considering the present uses and uses proposed in
this action.
ii. Chronic risk. Using the conservative exposure assumptions
described above, the aggregate exposure to sulfosate from food will
utilize 7.4% of the chronic RfD for the US population. The estimated
average concentrations of sulfosate in surface and ground water are
less than DWLOCs for sulfosate in drinking water as a contribution to
chronic aggregate exposure. Residues of sulfosate in drinking water do
not contribute significantly to the aggregate chronic human health risk
considering the present uses and uses proposed in this action.
2. Infants and children. The database on sulfosate relative to pre-
and post-natal toxicity is complete. Because the developmental and
reproductive effects occurred in the presence of parental (systemic)
toxicity, these data do not suggest an increased pre- or post-natal
sensitivity of children and infants to sulfosate exposure. Therefore,
Zeneca concludes, upon the basis of reliable data, that a 100-fold
uncertainty factor is adequate to protect the safety of infants and
children and an additional safety factor is unwarranted.
i. Acute risk. Using the conservative exposure assumptions
described above, the aggregate exposure to sulfosate from food will
utilize 23.2% of the acute RfD for the most highly exposed group, non-
nursing infants. The estimated peak concentrations of sulfosate in
surface and ground water are less than DWLOCs for sulfosate in drinking
water as a contribution to acute aggregate exposure. Residues of
sulfosate in drinking water do not contribute significantly to the
aggregate acute human health risk considering the present uses and uses
proposed in this action.
ii. Chronic risk. Using the conservative exposure assumptions
described above, we conclude that the percent of the RfD that will be
utilized by aggregate exposure to residues of sulfosate is 30.5% for
non-nursing infants, the most highly exposed group. The estimated
average concentrations of sulfosate in surface and ground water are
less than DWLOCs for sulfosate in drinking water as a contribution to
chronic aggregate exposure. Residues of sulfosate in drinking water do
not contribute significantly to the aggregate chronic human health risk
considering the present uses and uses proposed in this action.
F. International Tolerances
There are no Codex Maximum Residue Levels established for
sulfosate.
[FR Doc. 99-1120 Filed 1-19-99; 8:45 am]
BILLING CODE 6560-50-F
