[Federal Register Volume 63, Number 224 (Friday, November 20, 1998)]
[Notices]
[Pages 64481-64484]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-31070]
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ENVIRONMENTAL PROTECTION AGENCY
[PF-846; FRL-6043-9]
BASF Corporation; Pesticide Tolerance Petition Filing
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 a
certain pesticide chemical in or on various food commodities.
DATES: Comments, identified by the docket control number PF-846, must
be received on or before December 21, 1998.
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: Joanne I. Miller, Product Manager 23,
Herbicide Branch, 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.
237, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA
22202, (703) 305-6224; 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 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-846] (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-846) 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: November 4, 1998.
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. 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.
BASF Corporation
PP 6F 4604 and 4F 3041/FAP 4H5428
EPA has received pesticide petitions (PP 6F 4604 and 4F 3041/FAP
4H5428) from BASF Corporation, 26 Davis Drive, Research Triangle Park,
P.O. Box 13528, NC 27709, proposing pursuant to section 408 (d) of the
Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 346a(d), to amend 40
CFR 180.227 by establishing and revising tolerances for residues of the
herbicide dicamba (3,6-dichloro-o-anisic acid) and its two metabolites;
3,6-dichloro-5-hydroxy-o-anisic acid and 3,6-dichloro-2-hydroxybenzoic
acid. The tolerances requested for residues in or on the following raw
agricultural commodities are described as follows:
1. Revise tolerances for residues of dicamba (3,6-dichloro-o-anisic
acid) and its metabolite 3,6-dichloro-5-hydroxy-o-anisic acid in or on:
barley grain to 6 ppm, barley straw to 15 ppm; cottonseed to 3 ppm;
wheat grain to 2 ppm, wheat straw to 30 ppm.
2. Establish new tolerances for residues of dicamba (3,6-dichloro-
o-anisic acid) and its metabolite 3,6-dichloro-5-hydroxy-o-anisic acid
in or on: barley hay at 2 ppm, corn, field, forage at 3 ppm; corn,
field, stover at 3 ppm, corn, pop, stover at 3 ppm;
[[Page 64482]]
cottonseed meal at 5 ppm; Crop Group 17 (grass forage, fodder, and hay)
forage at 125 ppm and hay at 200 ppm; oats forage at 80 ppm, oats hay
at 20 ppm; wheat forage at 80 ppm, wheat hay at 20 ppm.
3. Revise tolerances for residues of dicamba (3,6-dichloro-o-anisic
acid) and its metabolite 3,6-dichloro-2-hydroxybenzoic acid in or on:
asparagus to 4 ppm.
4. Revise tolerances for residues of dicamba (3,6-dichloro-o-anisic
acid) and its metabolites; 3,6-dichloro-2-hydroxybenzoic acid and 3,6-
dichloro-5-hydroxy-o-anisic acid in or on: soybean seed to 10 ppm.
5. Establish new tolerances for residues of dicamba (3,6-dichloro-
o-anisic acid) and its metabolites; 3,6-dichloro-2-hydroxybenzoic acid
and 3,6-dichloro-5-hydroxy-o-anisic acid in or on: aspirated grain
fractions at 5,100 ppm, and soybean hulls at 13 ppm.
6. Delete the following tolerances: grasses, hay at 40 ppm;
grasses, pasture at 40 ppm; and grasses, rangeland at 40 ppm as these
tolerances are being replaced by Crop Group 17 in point 2.
The proposed analytical methods involve extraction, partition,
clean-up and detection of residues by gas chromatography/electron
capture detector (gc/ecd). 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 is adequately understood on the
basis of soybean, asparagus, cotton, sugarcane and published data on
grass. In the majority of registered crops, the major metabolite is the
3,6 dichloro-5-hydroxy-o-anisic acid. Tolerances are expressed as the
dicamba parent and/or the respective 5-hydroxy and 2-hydroxy
metabolites depending on the raw agricultural commodity of concern.
2. Analytical method. BASF Crop, has provided suitable
independently validated analytical methods for detecting and measuring
levels of dicamba and its metabolites in or on food with a limit of
detection that allows monitoring of food with residues at or above the
levels described in these and the existing tolerances. Adequate methods
are available in PAM-II for enforcement purposes. The analytical method
involves extraction, partition, clean-up and detection of residues by
gas chromatography/electron capture detector (gc/ecd).
3. Magnitude of residues--i. Plant. Residue trials have been
conducted with dicamba on the crops for expanded use requested in the
subject petitions. Multiple salts of dicamba were studied in side-by-
side testing to confirm that no effect on magnitude of the residues was
caused by the salt formulation type of the dicamba. The tolerances
listed in the first paragraph (section 1) are based on the maximum
expected residue from geographically representative field trial data.
Only newly generated data, or data not implicated in the CRAVEN
Laboratories indictment are used to support the subject petitions.
ii. Animal. The amended uses proposed do not yield secondary
residues in meat and milk above the tolerances already published under
40 CFR 180.227. Data from metabolism and feeding studies in poultry
have established that the maximum expected dietary burden from crops
treated with dicamba will not result in quantifiable residues above the
limits of the analytical method.
B. Toxicological Profile
Data are provided that are representative of the mammalian toxicity
effects of dicamba and are part of the many studies conducted to
support BASF Corp. assertion of safety of dicamba to humans.
1. Acute toxicity--i. Oral rat LD50: 1879 mg/kg (m);
1581 mg/kg (f).
ii. Acute dermal rat LD50: > 2,000 kg/kg (m/f).
iii. Acute inhalation rat LC50: > 9.6 mg/L (m/f).
iv. Primary eye irritation: Extremely irritating and corrosive to
the eye.
v. Primary dermal irritation rabbits. Not a primary skin irritant.
vi. Dermal sensitization guinea pigs. Moderate potential to cause
dermal sensitization.
vii. Acute neurotoxicity. no observed adverse effect level (NOAEL)
< 300="" milligrams/kilogram="" (mg/kg)="" (low="" dose).="" no="" neuropathological="" effects="" were="" found.="" 2.="" genotoxicty--="" ames-="" negative.="" in="" vitro="" chromosome="" aberration="" in="" chinese="" hamster="" ovary:="" negative;="" sex-linked="" recessive="" lethal="" in="" drosophila:="" negative;="" aberrations="" in="" rat="" bone="" marrow:="" negative;="" mitotic="" recombination:="" negative;="" udh="" (uds="" with="" wi-38="" human="" lung="" fibroblasts:="" negative;="" differential="" toxicity="" with="" e.="" coli="" pola="" and="" b.="" subtillus:="" positive;="" differential="" toxicity="" with="" s.="" typhimurium:="" negative;="" uds="" in="" human="" lung="" lymphocytes="" with="" activation:="" negative;="" slight="" increase="" of="" sister="" chromatid="" exchange="" in="" human="" cultured="" lymphocytes;="" positive="" in="" in="" vivo="" unwinding="" of="" liver="" dna="" in="" ip="" injected="" rats="" insert="" text.="" 3.="" reproductive="" and="" developmental="" toxicity--rodent="" developmental="" toxicity="" rat:="" oral="" doses="" of="" 0,="" 64,="" 160,="" or="" 400="" mg/kg="" were="" administered="" daily="" during="" gestation="" days="" 6="" to="" 19.="" the="" numbers="" of="" implantations,="" resorptions,="" and="" fetuses="" for="" test="" animals="" were="" similar="" to="" those="" numbers="" for="" control="" animals.="" no="" abnormalities="" were="" attributed="" to="" exposure="" to="" dicamba.="" technical="" dicamba="" was="" not="" found="" to="" be="" teratogenic="" with="" the="" test="" system/study="" design="" employed.="" maternal="" toxicity="" was="" found="" only="" at="" the="" hdt="" and="" the="" noael="" was="" 160="" mg/kg/day.="" 4.="" rabbit="" developmental="" toxicity.="" dicamba="" was="" administered="" orally="" (undiluted)="" via="" capsule="" to="" groups="" of="" 20="" artificially="" inseminated="" new="" zealand="" white="" rabbits.="" dose="" levels="" of="" 0,="" 30,="" 150,="" or,="" 300="" mg/kg="" were="" administered="" once="" daily="" on="" days="" 6-18="" of="" presumed-gestation="" (day="" 0="day" of="" insemination).="" females="" were="" sacrificed="" on="" day="" 29="" of="" presumed="" gestation.="" there="" were="" no="" deaths="" attributed="" to="" treatment.="" at="" the="" 150="" mg/="" kg="" and="" 300="" mg/kg="" levels,="" increased="" numbers="" of="" does="" with="" decreased="" motor="" activity="" and="" statistically="" significant="" numbers="" of="" does="" with="" ataxia="" were="" noted.="" at="" 300="" mg/kg,="" a="" significant="" number="" of="" does="" had="" rales="" and="" an="" increased="" number="" of="" does="" showed="" labored="" breathing,="" perinasal="" substance,="" dried="" feces,="" impaired="" righting="" reflex,="" and="" red="" substance="" in="" the="" cage="" pan.="" these="" clinical="" observations="" were="" considered="" to="" be="" effects="" of="" treatment.="" females="" in="" the="" 300="" mg/kg="" group="" had="" statistically="" significant="" body="" weight="" loss="" for="" the="" entire="" dosage="" period.="" at="" 150="" mg/kg,="" females="" lost="" weight="" on="" days="" 7-8="" of="" presumed="" gestation.="" although="" compensatory="" weight="" gains="" occurred="" during="" the="" post-treatment="" period="" (days="" 19-29-of="" gestation),="" body="" weight="" gains="" remained="" statistically="" significantly="" reduced="" on="" days="" 6-29="" of="" gestation="" in="" the="" 300="" mg/kg="" group.="" no="" significant="" differences="" were="" obtained="" in="" litter="" averages="" for="" corpora="" lutea,="" implants,="" litter="" sizes,="" resorption="" sites,="" percent="" male="" fetuses,="" fetal="" body="" weight,="" percent="" resorbed="" conceptuses="" or="" number="" of="" does="" with="" any="" resorptions.="" no="" gross="" external,="" soft="" tissue="" or="" skeletal="" alterations="" in="" fetuses="" were="" considered="" to="" be="" related="" to="" treatment.="" the="" maternal="" noael="" for="" technical="" dicamba="" to="" pregnant="" rabbits="" was="" 30="" mg/kg/day.="" levels="" of="" 150="" and="" 300="" mg/kg="" caused="" abortions,="" but="" were="" at="" significant="" maternally="" toxic="" doses.="" the="" developmental="" noael="" was="" the="" highest="" dose="" tested="" (hdt),="" 300="" mg/kg/day.="" [[page="" 64483]]="" there="" were="" no="" effects="" on="" embryo-fetal="" viability="" or="" development="" at="" any="" level.="" 5.="" 2-generation="" reproduction="" rat.="" potential="" effects="" on="" growth="" and="" reproductive="" performance="" were="" assessed="" over="" 2-generations="" of="" rats="" maintained="" on="" diets="" containing="" technical="" dicamba="" at="" concentrations="" of="" 0="" (control),="" 500,="" 1,500,="" or="" 5,000="" parts="" per="" million="" (ppm).="" exposure="" at="" 5,000="" ppm="" was="" associated="" with="" a="" slower="" growth="" rate="" of="" f1="" pups="" prior="" to="" weaning="" and="" resulted="" in="" lower="" initial="" body="" weights="" in="" those="" selected="" as="" parental="" animals.="" the="" lower="" body="" weight="" was="" associated="" with="" a="" decrease="" in="" both="" food="" consumption="" and="" water="" intake.="" sexual="" maturation="" was="" slightly="" delayed="" among="" males,="" but="" was="" likely="" associated="" with="" the="" initial="" reduced="" growth="" rate.="" increased="" liver="" weights="" were="" noted="" consistently="" for="" adults="" of="" both="" generations="" and="" for="" weanlings.="" there="" were="" no="" effects="" on="" reproductive="" ability="" from="" treatment="" at="" any="" level.="" the="" low="" pregnancy="" rate="" among="" f,="" females="" in="" all="" groups="" was="" considered="" to="" be="" due="" to="" increased="" weights="" of="" those="" females.="" the="" noael="" and="" lowest="" observed="" adverse="" effect="" level="" (loael)="" for="" system="" toxicity="" were="" 1,500="" and="" 5,000="" ppm,="" respectively.="" the="" noael="" and="" loael="" for="" reproductive="" toxicity="" were="" 500="" (45="" mg/kg/day)="" and="" 1,500="" ppm,="" respectively.="" 6.="" subchronic="" toxicity--21="" day="" dermal.="" there="" were="" no="" dicamba="" related="" changes="" in="" general="" behavior,="" appearance,="" body="" weight,="" or="" in="" blood="" and="" urine="" analysis.="" there="" were="" no="" compound-related="" gross="" pathology="" lesions,="" only="" skin="" lesions.="" there="" were="" no="" significant="" organ="" weight="" variations="" observed.="" 7.="" thirteen-week="" rodent="" feeding-rat.="" rats="" were="" offered="" technical="" dicamba="" at="" dietary="" concentrations="" of="" 0,="" 1,000,="" 5,000,="" or="" 10,000="" ppm.="" the="" mean="" body="" weight="" and="" food="" consumption="" values="" for="" the="" high="" dietary="" level="" animals="" were="" decreased="" from="" the="" control="" values.="" no="" adverse="" treatment-related="" findings="" were="" noted="" in="" either="" the="" blood="" parameters="" investigated="" or="" necropsy="" evaluation.="" microscopic="" examinations="" of="" the="" liver="" revealed="" an="" absence="" or="" reduction="" of="" cytoplasmic="" vacuolation="" in="" the="" hepatocytes="" of="" the="" high="" dietary="" level="" animals.="" the="" noael="" was="" suggested="" to="" be="" 5,000="" ppm.="" 8.="" eight-week="" non-rodent-dog.="" technical="" dicamba="" was="" offered="" orally="" at="" dietary="" concentrations="" of="" 0="" (control),="" 100,="" 500,="" or="" 2,500="" ppm="" to="" dogs="" for="" 1-year.="" initially,="" a="" decrease="" in="" food="" consumption="" was="" noted="" mainly="" among="" males="" at="" 500="" and="" 2,500="" ppm.="" this="" was="" most="" notable="" in="" a="" single="" 2,500="" ppm="" male="" resulting="" in="" almost="" no="" food="" consumed="" for="" the="" 1st="" 3="" weeks="" of="" feeding.="" following="" administration="" of="" the="" 2,500="" ppm="" diet="" in="" a="" water="" slurry="" during="" weeks="" 4-6,="" this="" male="" was="" placed="" back="" on="" feed="" and="" food="" consumption="" stabilized.="" there="" appears="" to="" be="" a="" limit="" to="" the="" amount="" of="" material="" that="" can="" be="" added="" to="" the="" feed="" before="" dogs="" will="" not="" consume="" the="" diet.="" the="" 2,500="" ppm="" level="" was="" considered="" close="" to="" the="" maximum="" that="" could="" be="" employed,="" as="" one="" dog="" failed="" to="" consume="" the="" diet="" when="" offered="" in="" the="" usual="" form.="" due="" mainly="" to="" the="" aforementioned="" male,="" mean="" body="" weight="" of="" 2,500="" ppm="" males="" did="" not="" increase="" until="" week="" 5.="" the="" overall="" body="" weight="" gain="" for="" the="" 1-year="" period="" was="" comparable="" for="" all="" groups.="" it="" was="" concluded="" that="" aside="" from="" the="" lower="" food="" consumption,="" the="" noael="" for="" toxicity="" was="" 50-60="" mg="" dicamba/kg="" body="" weight="" (2,500="" ppm)="" in="" both="" males="" and="" females.="" because="" of="" the="" lack="" of="" toxicity="" shown="" in="" this="" study="" the="" reference="" dose="" (rfd)="" peer="" review="" committee="" concurred="" that="" the="" noael="" was="" 2,500="" ppm="" hdt="" and="" a="" loael="" was="" not="" established.="" opp's="" hed="" branch="" is="" to="" decide="" if="" a="" new="" dog="" feeding="" study="" is="" required.="" 9.="" sub-chronic="" neurotoxicity.="" noael="" was="" established="" at="" 401="" (m)="" and="" 472="" (f)="" mg/kg/day.="" no="" histopathological="" effects="" on="" the="" peripheral="" or="" central="" nervous="" system="" were="" noted.="" 10.="" chronic="" toxicity--chronic="" feeding/oncogenicity="" in="" rat.="" groups="" of="" 60="" rats/sex="" were="" maintained="" on="" diets="" containing="" technical="" dicamba="" at="" concentrations="" of="" either="" 0,="" 50,="" 250,="" or="" 2,500="" ppm.="" an="" interim="" sacrifice="" of="" 10/sex/level="" was="" conducted="" at="" 12="" months.="" initially="" scheduled="" as="" a="" 27="" month="" study,="" males="" were="" sacrificed="" at="" 115-weeks="" and="" females="" at="" 118-="" weeks="" due="" to="" survival="" rates.="" in="" males,="" no="" statistically="" significant="" differences="" in="" data="" for="" all="" tumors="" combined,="" all="" benign="" tumors="" combined,="" and="" all="" malignant="" tumors="" combined="" were="" obtained.="" a="" slight="" increase="" in="" malignant="" lymphoma="" was="" not="" statistically="" significant="" (pairwise="" comparisons)="" and="" was="" not="" considered="" to="" be="" toxicologically="" significant.="" a="" slight="" increase="" in="" thyroid="" parafollicular="" cell="" carcinoma="" in="" the="" high="" treatment="" group="" was="" noted="" but="" was="" not="" statistically="" significant="" in="" pairwise="" comparisons.="" in="" females,="" no="" statistically="" significant="" differences="" were="" noted="" in="" comparisons="" with="" all="" tumors="" combined,="" all="" benign="" tumors="" combined,="" and="" all="" malignant="" tumors="" combined="" or="" in="" any="" individual="" tumor="" type.="" in="" summary,="" no="" signs="" of="" toxicity="" related="" to="" administration="" of="" dicamba="" were="" noted.="" findings="" among="" animals="" in="" the="" three="" treatment="" groups="" were="" considered="" to="" be="" comparable="" to="" findings="" among="" the="" control="" animals.="" dicamba="" was="" not="" oncogenic="" for="" animals="" of="" the="" species,="" strain,="" and="" age="" under="" the="" conditions="" of="" the="" study.="" based="" on="" the="" results="" of="" the="" study,="" the="" no="" effect="" level="" was="" considered="" to="" be="" 2,500="" ppm.="" 11.="" oncogenicity="" in="" mice.="" groups="" of="" 52="" male="" and="" 52="" female="" mice="" were="" fed="" diets="" containing="" dicamba="" at="" oncentrations="" of="" 0,="" 50,="" 150,="" 1,000,="" or="" 3,000="" ppm.="" males="" were="" killed="" following="" 89-weeks="" of="" feeding="" and="" females="" were="" killed="" following="" 104-weeks="" of="" feeding.="" reduced="" body="" weight="" gain="" (not="" statistically="" different)="" was="" noted="" among="" 3,000="" ppm="" females.="" increased="" mortality="" noted="" among="" 3,000="" ppm="" males="" was="" considered="" unlikely="" to="" be="" related="" to="" treatment="" but="" could="" not="" be="" completely="" excluded.="" an="" increased="" incidence="" in="" lymphoid="" tumors,="" showing="" a="" statistical="" significance="" at="" 150="" and="" 1,000="" ppm,="" occurred="" in="" females.="" however,="" the="" incidence="" at="" 3,000="" ppm="" did="" not="" statistically="" differ="" from="" control.="" additionally,="" there="" was="" no="" significant="" trend="" with="" dosage="" and="" the="" values="" for="" treated="" females="" were="" within="" historical="" control="" data.="" finally,="" the="" incidence="" of="" benign="" and="" malignant="" tumors="" in="" any="" tissue="" were="" similar="" for="" treated="" and="" control="" animals.="" administration="" of="" dicamba="" in="" the="" diet="" at="" achieved="" intakes="" ranging="" from="" 5.5="" to="" 364="" mg/kg/day="" produced="" no="" evidence="" of="" tumorigenic="" potential.="" generally,="" no="" findings="" among="" mice="" receiving="" 1,000="" ppm="" or="" below="" were="" considered="" to="" be="" of="" toxicological="" significance.="" the="" dietary="" level="" of="" 1,000="" ppm="" (108="" mg/kg/day="" in="" males="" and="" 121="" mg/kg/day="" in="" females)="" was="" defined="" as="" the="" no="" toxic="" effect="" level.="" however,="" the="" rfd="" committee="" chose="" to="" establish="" the="" noael="" at="" 3,000="" ppm="" and="" stated="" that="" no="" loael="" had="" been="" established.="" 12.="" estrogenic="" or="" other="" ndocrine="" effects.="" no="" specific="" tests="" have="" been="" conducted="" with="" dicamba="" to="" determine="" whether="" the="" pesticide="" may="" have="" an="" effect="" in="" humans="" that="" is="" similar="" to="" an="" effect="" produced="" by="" a="" naturally="" occurring="" estrogen="" or="" other="" endocrine="" effect.="" however,="" available="" data="" have="" not="" implicated="" dicamba="" in="" such="" effects.="" 13.="" animal="" metabolism.="" dicamba="" has="" been="" tested="" in="" rats,="" dogs,="" cattle,="" goats="" and="" hens.="" in="" all="" cases,="" dicamba="" is="" excreted="" very="" rapidly,="" mainly="" as="" unchanged="" dicamba="" and="" to="" a="" lesser="" extent="" as="" 3,6-dichloro-2-="" hydroxybenzoic="" acid="" with="" trace="" amounts="" of="" 3,6-dichloro-5-hydroxy-o-="" anisic="" acid.="" the="" results="" of="" these="" studies="" demonstrate="" that="" dicamba="" is="" not="" persistent="" and="" does="" not="" accumulate="" in="" animals.="" 14.="" metabolite="" toxicology.="" toxicity="" of="" the="" metabolites="" of="" dicamba="" to="" humans="" is="" concurrently="" evaluated="" during="" toxicity="" testing="" because="" both="" plant="" and="" animal="" metabolites="" are="" formed="" during="" the="" [[page="" 64484]]="" course="" of="" toxicity="" tests.="" both="" plant="" and="" animal="" major="" metabolites="" are="" considered="" not="" of="" toxicological="" concern.="" c.="" aggregate="" exposure="" 1.="" dietary="" exposure.="" exposure="" from="" the="" use="" of="" dicamba="" in="" the="" culture="" of="" wheat,="" barley,="" oats,="" millet,="" sorghum,="" corn,="" soybeans,="" grasses,="" cotton,="" sugarcane="" and="" asparagus="" crops="" is="" discussed="" under="" the="" below="" topics="" of="" food="" and="" drinking="" water.="" 2.="" food.="" the="" subject="" petition="" amends="" these="" uses="" but="" does="" not="" add="" new="" crops.="" the="" potential="" dietary="" exposure="" of="" the="" population="" to="" residues="" of="" dicamba="" or="" its="" metabolites="" is="" calculated="" based="" on="" the="" theoretical="" maximum="" residue="" contribution="" (tmrc)="" for="" all="" crops="" with="" dicamba="" use.="" the="" tmrc="" is="" a="" worst="" case="" estimate="" of="" dietary="" exposure="" since="" it="" assumes="" that="" 100%="" of="" all="" crops="" for="" which="" tolerances="" are="" established="" are="" treated="" with="" dicamba,="" and="" that="" pesticide="" residues="" are="" present="" at="" the="" tolerance="" levels.="" the="" resulting="" dietary="" exposure="" estimate="" therefore="" overestimates="" exposure="" and="" is="" considered="" conservative.="" the="" number="" is="" then="" determined="" to="" be="" a="" percentage="" of="" the="" epa="" decided="" rfd.="" dietary="" exposure="" may="" occur="" from="" crop="" commodities="" and="" meat="" and="" milk.="" based="" on="" the="" epa="" dres="" model="" basf="" corp.="" has="" estimated="" that="" the="" average="" u.s.="" population="" dietary="" exposure="" to="" dicamba="" to="" be="" only="" 1.87%="" of="" the="" rfd.="" this="" number="" is="" very="" low="" and="" considered="" very="" safe="" as="" an="" active="" ingredient="" is="" allowed="" up="" to="" 100%="" before="" less="" conservative="" risk="" assessment="" measures="" are="" initiated.="" acute="" dietary="" analysis="" compared="" the="" daily="" dietary="" exposure="" to="" the="" lowest="" noael="" for="" acute="" and="" subchronic="" studies.="" epa's="" current="" policy="" for="" tier="" i="" analysis="" uses="" the="" conservative="" assumption="" that="" all="" residues="" are="" at="" a="" high="" end="" estimate="" or="" maximum,="" typically="" taken="" as="" the="" tolerance="" value.="" acute="" dietary="" assessment="" for="" dicamba="" is="" made="" by="" comparing="" the="" ratio="" of="" exposure="" and="" the="" noael="" from="" acute="" neurotoxicity="" of="" 300="" mg/kg/="" day="" to="" achieve="" a="" margin="" of="" exposure="" (moe).="" a="" moe="" of="" 300="" is="" required="" because="" a="" noael="" was="" not="" reached="" in="" the="" acute="" neurotoxicity="" test.="" the="" following="" moe="" values="" are="" obtained="" for="" key="" population="" subgroups.="" ------------------------------------------------------------------------="" population="" subgroup="" margin="" of="" exposure="" ------------------------------------------------------------------------="" us="" population.............................="" 16000="" infants=""><1 year...........................="" 13000="" children="" 1="" to="" 6...........................="" 13000="" females="" 13+="" years.........................="" 117000="" males="" 13+="" years...........................="" 110000="" ------------------------------------------------------------------------="" 3.="" drinking="" water.="" dicamba="" has="" been="" used="" commercially="" for="" in="" excess="" of="" 30="" years.="" from="" available="" public="" data,="" detections="" in="" ground="" water="" from="" commercial="" uses="" have="" been="" very="" low="" and="" infrequent.="" the="" typical="" level="" found="" in="" ground="" water="" is="" less="" than="" 5="" ppb.="" this="" should="" be="" compared="" to="" the="" current="" health="" advisory="" level="" (hal)="" of="" 200="" ppb="" and="" the="" anticipated="" hal="" of="" 3,000="" ppb="" under="" the="" newly="" revised="" rfd="" of="" 0.45="" mg/kg/="" day.="" these="" infrequent="" and="" low="" levels="" of="" detection="" in="" groundwater="" demonstrate="" that="" significant="" movement="" of="" dicamba="" is="" not="" likely="" and="" is="" not="" a="" considerable="" factor="" in="" assessing="" human="" health="" risk.="" 4.="" non-dietary="" exposure.="" non-dietary="" exposure="" would="" mainly="" occur="" from="" the="" use="" of="" dicamba="" for="" broadleaf="" weed="" control="" on="" residential="" or="" recreational="" turf.="" basf="" is="" currently="" collecting="" data="" on="" the="" potential="" exposure="" from="" non-dietary="" sources="" such="" as="" residential="" turf="" use.="" however,="" no="" reliable="" information="" are="" currently="" available="" for="" risk="" assessment="" at="" this="" time.="" this="" petition="" is="" only="" related="" to="" already="" approved="" crop="" uses="" and="" therefore="" non-dietary="" route="" of="" exposure="" is="" not="" considered="" to="" be="" a="" factor="" in="" assessing="" additional="" human="" risk.="" d.="" cumulative="" effects="" dicamba="" belongs="" to="" the="" benzoic="" acid="" class="" of="" compounds.="" there="" are="" no="" other="" compounds="" of="" this="" class="" in="" significant="" use="" and="" none="" in="" food="" use.="" therefore,="" cumulative="" effects="" from="" dietary="" or="" non-occupational="" exposure="" from="" pesticides="" of="" similar="" chemistry="" are="" considered="" unlikely.="" basf="" corp.="" does="" not="" have="" reliable="" data="" to="" indicate="" a="" common="" mechanism="" of="" toxicity="" to="" other="" compounds.="" therefore="" cumulative="" effects="" from="" common="" mechanisms="" of="" action="" are="" also="" unlikely.="" e.="" safety="" determination="" the="" rfd="" for="" dicamba="" is="" 0.45="" mg/kg/day.="" the="" rfd="" is="" a="" level="" at="" or="" below="" which="" daily="" aggregate="" exposure="" over="" a="" lifetime="" will="" not="" cause="" appreciable="" human="" health="" risk.="" the="" estimates="" of="" exposure="" are="" based="" on="" conservative="" assumptions="" that="" all="" crops="" with="" a="" tolerance="" for="" dicamba="" are="" treated="" and="" that="" all="" residues="" found="" are="" at="" the="" maximum="" or="" tolerance="" level.="" 1.="" u.s.="" population.="" using="" the="" conservative="" assumptions="" described="" above,="" basf="" corp.="" has="" estimated="" that="" the="" u.s.="" population="" dietary="" exposure="" to="" dicamba="" is="" 1.87%="" of="" the="" rfd.="" 2.="" infants="" and="" children.="" dicamba="" is="" not="" a="" reproductive="" or="" developmental="" toxicant.="" therefore="" no="" specific="" effects="" on="" infants="" and="" children="" are="" expected.="" based="" on="" the="" weight="" of="" evidence="" of="" the="" toxicity="" studies="" an="" additional="" safety="" factor="" is="" not="" warranted.="" using="" the="" conservative="" assumptions="" described="" above,="" basf="" corp.="" has="" estimated="" the="" dietary="" exposure="" to="" infants="" and="" children="" as="" percent="" of="" the="" rfd.="" from="" the="" current="" and="" new="" proposed="" use="" of="" dicamba="" dietary="" exposure="" for="" the="" most="" sensitive="" subgroups="" are="" 6.65%="" for="" non-nursing="" infants=""><1-year old)="" and="" 4.6%="" for="" children="" 1-6="" years="" old.="" aggregate="" exposure="" due="" to="" the="" combined="" residues="" in="" food,="" drinking="" water="" and="" non-dietary="" exposure="" through="" direct="" contact="" with="" residues="" in="" a="" residential="" setting="" (lawn)="" should="" be="" pursued="" through="" the="" use="" of="" a="" reserve="" risk="" approach.="" the="" elements="" for="" consideration="" are="" therefore="" estimated="" as="" follows:=""> Food: Total Population 1.87%
Non-nursing Infants <6yrs. 6.7%=""> Water/Lawn: Low human risk......expected to be
inconsequential
BASF Corp. believes that the water and non-dietary exposure risk
for the most sensitive subgroup is inconsequential due to demonstrated
low findings in water relative to the HAL and low toxicity to humans
with respect to oral, dermal and inhalation exposure.
Aggregate exposure is therefore estimated to be less than 10% of
the RfD for the most sensitive population subgroup. Therefore, BASF
Corp. concludes that there is reasonable certainty that no harm will
result from aggregate exposure of residues of dicamba or its
metabolites including all dietary and other non-occupational exposures.
F. International Tolerances
No international tolerances have been established under CODEX.
Therefore there is no need to ensure consistency.
[FR Doc. 98-31070 Filed 11-19-98; 8:45 am]
BILLING CODE 6560-50-F
