[Federal Register Volume 62, Number 48 (Wednesday, March 12, 1997)]
[Notices]
[Pages 11450-11453]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-6209]
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ENVIRONMENTAL PROTECTION AGENCY
[PF-721; FRL-5592-7]
BASF Corporation; Pesticide Tolerance Petition Filing
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of filing.
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SUMMARY: This notice announces the filing of pesticide petitions
proposing the tolerances for residues of the pesticide pyridaben, [2-
tert-butyl-5-(4-ter-butylbenzylthio)-4-chloropyridazin-3(2H)-one] and
its metabolites PB-7 (2-tert-butyl-5-[4-(1-carboxy-1-
methylethyl)benzylthio]-4-chloropyridazin-3(2H)-one) and PB-9 (2-tert-
butyl-4-chloro-5-[4-(1,1-dimethyl-2-hydroxyethyl)benzylthio]-
chloropyridazin-3(2H)-one). BASF is petitioning EPA for the
establishment of tolerances for use of pyridaben to control certain
pests on apples, pears, citrus, almonds, peaches (imported commodity),
plums (imported commodity), and grapes (imported commodity). The
proposed tolerances for pyridaben are: apples at 0.6 ppm, wet apple
pomace at 1.0 ppm, pears at 0.75 ppm, citrus at 0.5 ppm, dried citrus
pulp at 1.5 ppm, citrus oil at 10.0 ppm, almonds at 0.05 ppm, almond
hulls at 4.0 ppm, peaches at 0.05 ppm, plums at 0.05 ppm, and grapes at
0.75 ppm. The proposed tolerances for pyridaben and its metabolites
are: milk at 0.01 ppm, meat at 0.05 ppm, meat by-products at 0.05 ppm,
and fat at 0.05 ppm. This summary was prepared by the petitioner.
DATES: Comments, identified by the docket control number [PF-721], must
be received on or before April 11, 1997.
ADDRESSES: By mail, submit written comments to: Public Response and
Program Resources Branch, Field Operations Division (7506C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW,
Washington, DC 20460. In person, bring comments to: Rm. 1132 CM #2,
1921 Jefferson Davis Highway, Arlington, VA 22202. Comments and data
may also be submitted electronically by sending electronic mail (e-
mail) to: 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. Comments and data will also be accepted on
disks in WordPerfect 5.1 file format or in ASCII file format. All
comments and data in electronic form must be identified by the docket
control number [PF-721]. Electronic comments on this notice may be
filed online at many Federal Depository Libraries. Additional
information on electronic submissions can be found in Unit II. of this
document.
Information submitted as comments concerning this notice may be
claimed confidential by marking any part or all of that information as
``Confidential Business Information'' (CBI). The CBI should not be
submitted through e-mail. Information marked as CBI will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2. A copy of the comment that does not contain CBI must be submitted
for inclusion in the public record. Information not marked confidential
may be disclosed publicly by EPA without prior notice. All written
comments will be available for public inspection in Rm. 1132 at the
address given above, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays.
FOR FURTHER INFORMATION CONTACT: Richard Keigwin, Product Manager (PM)
10, Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
Office location, telephone number, and e-mail: Crystal Mall #2, Rm.
210, 1921 Jefferson Davis Highway, Arlington, VA 22202, 703-305-6788,
e-mail: keigwin.richard@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA has received pesticide petitions (PP)
5F4543 (on citrus), 4E4370 (on imported commodities) and 6F4651
(apples), 6F4741 (almonds), and 6F4721 (pears) from BASF Corporation,
Agricultural Products, PO Box 13528, Research Triangle Park, NC 27709.
The petition proposes, pursuant to section 408 of the Federal Food,
Drug and Cosmetic Act (FFDCA), 21 U.S.C section 346a, to amend 40 CFR
part 180 to establish tolerances for the pesticide pyridaben [2-tert-
butyl-5-(4-ter-butylbenzylthio)-4-chloropyridazin-3(2H)-one] in or on
the raw agricultural commodities: apples, wet apple pomace, pears,
citrus, dried citrus pulp, citrus oil, almonds, almond hulls, peaches,
plums, and grapes, respectively. The petition also proposes to
establish tolerances for pyridaben and its metabolites PB-7 (2-tert-
butyl-5-[4-(1-carboxy-1-methylethyl)benzylthio]-4-chloropyridazin-
3(2H)-one) and PB-9 (2-tert-butyl-4-chloro-5-[4-(1,1-dimethyl-2-
hydroxyethyl)benzylthio]-chloropyridazin-3(2H)-one) in or on the raw
agricultural commodities: milk, meat, meat-by-products, and fat. EPA
has determined that the petitions contain 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 this petition. Additional
data may be needed before EPA rules on the petition.
As required by section 408(d) of the FFDCA, as recently amended by
the Food Quality Protection Act (FQPA), Pub. L. 104-170, BASF included
in the petition a summary of the petition and authorization for the
summary to be published in the Federal Register in a notice of receipt
of the petition. The summary represents the views of BASF. EPA is in
the process of evaluating the petition. As required by section
408(d)(3) of the FFDCA, EPA is including the summary as a part of the
notice of filing. EPA may have made minor edits to the summary for the
purpose of clarity.
I. Petition Summary
A. Plant and Animal Metabolism
BASF Corporation notes that metabolism in plants and animals is
understood.
B. Analytical Method
The proposed analytical method involves extraction, partition,
clean-up and detection of residues by gas chromatography/electron
capture detector (gc/ecd).
C. Magnitude of the Residues
Nine pear residue trials were conducted in six states. Residues of
pyridaben were measured by gc/ecd. The method of detection had a limit
of detection of 0.05 parts per million (ppm). Residues ranged from 0.07
to 0.58 ppm.
Twelve apple residue trials were conducted in six states. Residues
of
[[Page 11451]]
pyridaben were measured by gc/ecd. The method of detection had a limit
of detection of 0.05 ppm. Residues ranged from 0.08 to 0.44 ppm.
Nineteen citrus residue trials were conducted in four states.
Residues of pyridaben were measured by gc/ecd. The method of detection
had a limit of detection of 0.05 ppm. Residues ranged from 0.05 to 0.42
ppm.
Eight almond residue trials were conducted in California. Residues
of pyridaben were measured by gc/ecd. The method of detection had a
limit of detection of 0.05 ppm. Residues were < 0.05="" ppm="" in="" all="" trials.="" eight="" peach="" residue="" trials="" were="" conducted="" in="" chile.="" residues="" of="" pyridaben="" were="" measured="" by="" gc/ecd.="" the="" method="" of="" detection="" had="" a="" limit="" of="" detection="" of="" 0.05="" ppm.="" residues="" were="">< 0.05="" ppm="" in="" all="" trials.="" six="" plum="" residue="" trials="" were="" conducted="" in="" chile.="" residues="" of="" pyridaben="" were="" measured="" by="" gc/ecd.="" the="" method="" of="" detection="" had="" a="" limit="" of="" detection="" of="" 0.05="" ppm.="" residues="" were="">< 0.05="" ppm="" in="" all="" trials.="" eight="" grape="" residue="" trials="" were="" conducted="" in="" chile.="" residues="" of="" pyridaben="" were="" measured="" by="" gc/ecd.="" the="" method="" of="" detection="" had="" a="" limit="" of="" detection="" of="" 0.05="" ppm.="" residues="" ranged="" from="">< 0.05="" to="" 0.22="" ppm.="" d.="" toxicological="" profile="" 1.="" acute="" toxicity="" testing.="" a.="" acute="" oral="" toxicity="" (rat):="">50
= 1100 milligrams/kilogram (mg/kg) in males; 570 mg/kg in females. Tox
Category: III
b. Acute oral toxicity (mouse): LD50 = 424 mg/kg in males; 383
mg/kg in females. Tox Category: II
c. Acute dermal toxicity (rat): LD50 = > 2000 mg/kg in males
and females. Tox Category: III
d. Acute inhalation toxicity (rat): LC50 = 0.66 mg/l in males;
0.62 mg/l in females. Tox Category: III
e. Primary eye irritation (rabbit): Pyridaben is a slight ocular
irritant. Tox Category: III
f. Primary dermal irritation (rabbit): Pyridaben is not a dermal
irritant. Tox Category: IV
g. Dermal sensitization (guinea pig): Pyridaben is not a dermal
sensitizer.
2. Acute neurotoxicity (rat): Rats were dosed once with 0, 50, 100
and 200 mg/kg. The no observed effect level (NOEL) for systemic
toxicity was determined to be 50 mg/kg for both males and females. The
lowest observed effect level (LOEL) for systemic effects was determined
to be 100 mg/kg in both sexes based on decreased food consumption,
decreased body weight gain and increased clinical signs. The LOEL for
neurobehavioral effects was determined to be 200 mg/kg in males and
>200 mg/kg in females.
3. Subchronic toxicity testing. a. 21-Day dermal (rat): Rats were
repeatedly dosed with pyridaben at 0, 30, 100, 300 and 1000 mg/kg/day
for 21 days. The NOEL was determined to be 100 mg/kg/day and the LOEL
300 mg/kg/day based on decreased body weight gain in females.
b. 90-Day rodent (rat): CD rats were dosed with pyridaben at 0, 30,
65, 155 and 350 ppm in the diet for 13 weeks. The NOEL was determined
to be 65 ppm (4.94 mg/kg/day) for males and 30 ppm (2.64 mg/kg/day) in
females. The LOEL for males was determined to be 155 ppm (11.55 mg/kg/
day) based on reduced body weight gain, reduced food consumption,
reduced food efficiency, and altered clinical pathology parameters. The
LOEL for females was determined to be 65 ppm (5.53 mg/kg/day) based on
reduced body weight gain and reduced food efficiency.
c. 90-Day non-rodent (dog): Beagle dogs were dosed with pyridaben
at 0, 0.5, 1, 4, and 16 mg/kg/day in the diet for 13 weeks. The NOEL
was determined to be 1 mg/kg/day and the LOEL determined to be 4 mg/kg/
day based on reduced body weight gain and an increase in clinical signs
in both sexes.
d. 90-Day neurotoxicity (rat): Rats were dosed with pyridaben at 0,
30, 100, and 350 ppm in the diet for 13 weeks. The systemic NOEL was
determined to be 100 ppm (equivalent to 8.5 mg/kg/day in males and 9.3
mg/kg/day in females). The systemic LOEL was determined to be 350 ppm
(equivalent to 28.8 mg/kg/day in males and 31.1 mg/kg/day in females)
based on decreased body weight gain, decreased food consumption and
decreased food efficiency. No neuropathological effects were noted in
the study.
4. Chronic toxicity testing. a. 1-Year non-rodent (dog): Two
studies were run. In the first, beagle dogs were dosed with pyridaben
at 0, 1, 4, 16 and 32 mg/kg/day in the diet for one year. In the
second, beagle dogs were dosed with pyridaben at 0 and 0.5 mg/kg/day in
the diet for 1 year. The NOEL was determined to be <0.5 ppm="" and="" loel="" determined="" to="" be="" 0.5="" mg/kg/day="" based="" on="" increased="" clinical="" signs="" and="" decreased="" body="" weight="" gain="" in="" both="" sexes.="" b.="" combined="" rodent="" chronic="" toxicity/carcinogenicity="" (rat):="" wistar="" rats="" were="" fed="" 0,="" 4,="" 10,="" 28="" and="" 80="" ppm="" pyridaben="" in="" the="" diet="" to="" assess="" carcinogenicity="" and="" 0,="" 4,="" 10,="" 28="" and="" 120="" ppm="" in="" the="" diet="" to="" assess="" chronic="" toxicity="" for="" 104="" weeks.="" the="" noel="" was="" determined="" to="" be="" 28="" ppm="" in="" both="" sexes="" (equivalent="" to="" 1.13="" mg/kg/day="" in="" males="" and="" 1.46="" mg/kg/day="" in="" females).="" the="" loel="" was="" determined="" to="" be="" 120="" ppm="" in="" both="" sexes="" (equivalent="" to="" 5.0="" mg/kg/day="" in="" males="" and="" 6.52="" mg/kg/day="" in="" females)="" based="" on="" decreased="" body="" weight="" gain="" in="" both="" sexes="" and="" decreased="" alanineamino="" transferase="" (alt)="" levels="" in="" males.="" pyridaben="" was="" not="" carcinogenic="" under="" the="" conditions="" of="" the="" test.="" c.="" carcinogenicity="" in="" the="" rodent="" (mouse):="" cd-1="" mice="" were="" fed="" 0,="" 2.5,="" 8.0,="" 25="" and="" 80="" ppm="" pyridaben="" in="" the="" diet="" for="" 78="" weeks.="" the="" noel="" was="" determined="" to="" be="" 25="" ppm="" in="" both="" sexes="" (equivalent="" to="" 2.78="" mg/kg/day="" in="" both="" sexes).="" the="" loel="" was="" determined="" to="" be="" 80="" ppm="" in="" both="" sexes="" (equivalent="" to="" 8.88="" mg/kg/day="" in="" males="" and="" 9.74="" mg/kg/day="" in="" females)="" based="" on="" decreased="" body="" weight="" gain,="" decreased="" food="" efficiency="" and="" changes="" in="" organ="" weights="" and="" histopathology.="" pyridaben="" was="" not="" carcinogenic="" under="" the="" conditions="" of="" the="" test.="" 5.="" developmental="" toxicity="" testing.="" a.="" developmental="" toxicity="" (rat):="" sprague-dawley="" rats="" were="" dosed="" with="" 0,="" 2.5,="" 5.7,="" 13="" and="" 30="" mg/kg/day="" pyridaben="" in="" the="" diet="" from="" days="" 6="" through="" 15="" of="" gestation.="" the="" maternal="" noel="" was="" determined="" to="" be="" 4.7="" mg/kg/day="" and="" the="" maternal="" loel="" was="" determined="" to="" be="" 13="" mg/kg/day="" based="" on="" decreased="" body="" weight="" gain,="" and="" decreased="" food="" consumption="" during="" the="" dosing="" period.="" the="" developmental="" noel="" was="" determined="" to="" be="" 13="" mg/kg/day="" and="" the="" developmental="" loel="" was="" determined="" to="" be="" 30="" mg/kg/day="" based="" on="" decreased="" fetal="" body="" weight="" and="" an="" increase="" in="" incomplete="" ossification="" in="" selected="" bones.="" b.="" developmental="" toxicity="" (rabbit):="" new="" zealand="" white="" rabbits="" were="" dosed="" with="" 0,="" 1.5,="" 5,="" and="" 15="" mg/kg/day="" pyridaben="" in="" the="" diet="" from="" days="" 6="" through="" 19="" of="" gestation.="" the="" maternal="" noel="" was="" determined="" to="" be="" 5="" mg/="" kg/day="" and="" the="" maternal="" loel="" was="" determined="" to="" be="" 15="" mg/kg/day="" based="" on="" decreased="" body="" weight="" gain,="" and="" decreased="" food="" consumption="" during="" the="" dosing="" period.="" the="" developmental="" noel="" was="" determined="" to="" be=""><15 mg/kg/="" day="" and="" the="" developmental="" loel="" was="" determined="" to="" be=""><15 mg/kg/day.="" c.="" developmental="" toxicity="" (rabbit):="" himalayan="" rabbits="" were="" dosed,="" by="" dermal="" application,="" with="" 0,="" 70,="" 170="" and="" 450="" mg/kg/day="" pyridaben="" from="" days="" 6="" through="" 19="" of="" gestation.="" the="" maternal="" systemic="" noel="" was="" determined="" to="" be="" 70="" mg/kg/day="" and="" the="" maternal="" loel="" was="" determined="" to="" be="" 170="" mg/kg/day="" based="" on="" decreased="" body="" weight="" gain,="" and="" decreased="" food="" consumption="" during="" the="" dosing="" period.="" the="" developmental="" noel="" was="" determined="" to="" be="" 170="" mg/kg/day="" and="" the="" loel="" determined="" to="" be="" 450="" [[page="" 11452]]="" mg/kg/day="" based="" on="" decreased="" ossification="" of="" the="" skull.="" 6.="" reproductive="" toxicity="" testing.="" multi-generation="" reproduction="" (rat):="" cd="" rats="" were="" dosed="" with="" 0,="" 10,="" 28="" and="" 80="" ppm="" pyridaben="" in="" the="" diet.="" the="" parental/systemic="" noel="" was="" determined="" to="" be="" 28="" ppm="" in="" both="" sexes="" (equivalent="" to="" 2.20="" mg/kg/day="" in="" males="" and="" 2.41="" mg/kg/day="" in="" females).="" the="" parental/systemic="" loel="" was="" determined="" to="" be="" 80="" ppm="" (equivalent="" to="" 6.31="" mg/kg/day="" in="" males="" and="" 7.82="" mg/kg/day="" in="" females)="" based="" on="" decreased="" body="" weight,="" decreased="" body="" weight="" gain="" and="" decreased="" food="" efficiency.="" the="" reproductive="" noel="" and="" loel="" were="" both="" determined="" to="" be="">80 ppm in males and females.
7. Mutagenicity testing. a. Ames Testing: Negative
b. In vitro cytogenicity (Chinese hamster lung cells): Negative
c. In vivo micronucleus assay (mouse): Negative
d. DNA damage/repair (E. coli): Negative
E. Threshold Effects
Based on the available chronic toxicity data, EPA has established
the Reference Dose (RfD) for pyridaben at 0.005 mg/kg/day. The RfD for
pyridaben is based on a 1-year feeding study in dogs with a threshold
LOEL of 0.5 mg/kg/day based on increased clinical signs and decreased
body weight gain in both sexes and an uncertainty factor of 100.
F. Non-Threshold Effects
Using its Guidelines for Carcinogenic Risk Assessment, EPA has
classified pyridaben as Group ``E '' for carcinogenicity (no evidence
of carcinogenicity) based on the results of carcinogenicity studies in
two species. There was no evidence of carcinogenicity in an 18-month
feeding study in mice and a 2-year feeding study in rats at the dosage
levels tested. The doses tested were adequate for identifying a cancer
risk. Thus, a cancer risk assessment is not necessary.
G. Aggregate Exposure
1. Dietary exposure. Since pyridaben is regulated based upon non-
carcinogenic chronic toxicity, BASF conducted a DRES analysis based on
anticipated residue levels determined by EPA. The anticipated residue
levels were derived from the average residue levels from field trials
conducted at the maximum proposed use rate and minimum pre-harvest
interval, and a correction factor of 2.3 to account for all
organosoluble residues as determined by EPA. This analysis demonstrates
that the exposure to non-nursing infants < 1="" year,="" the="" most="" sensitive="" subpopulation="" is="" approximately="" 73.4="" percent="" of="" the="" rfd="" and="" to="" the="" general="" population="" exposure="" is="" approximately="" 11.3="" percent="" of="" the="" rfd.="" 2.="" ``other''="" exposure.="" other="" potential="" sources="" of="" exposure="" of="" the="" general="" population="" to="" residues="" of="" pesticides="" are="" residues="" in="" drinking="" water="" and="" exposure="" from="" non-occupational="" sources.="" based="" on="" the="" studies="" submitted="" to="" epa="" for="" assessment="" of="" environmental="" risk,="" basf="" does="" not="" anticipate="" exposure="" to="" residues="" of="" pyridaben="" in="" drinking="" water.="" there="" is="" no="" established="" maximum="" concentration="" level="" for="" residues="" of="" pyridaben="" in="" drinking="" water="" under="" the="" safe="" drinking="" water="" act.="" basf="" has="" not="" estimated="" non-occupational="" exposure="" for="" pyridaben="" since="" the="" current="" registration="" for="" pyridaben="" is="" limited="" to="" commercial="" greenhouse="" use="" for="" non-food="" ornamental="" plants="" and="" the="" only="" other="" domestic="" use="" will="" be="" for="" commercial="" apple,="" pear,="" citrus="" and="" almond="" production.="" the="" potential="" for="" non-occupational="" exposure="" to="" the="" general="" population="" is="" considered="" to="" be="" insignificant.="" 3.="" cumulative="" exposure.="" basf="" also="" considered="" the="" potential="" for="" cumulative="" effects="" of="" pyridaben="" and="" other="" substances="" that="" have="" a="" common="" mechanism="" of="" toxicity.="" basf="" has="" concluded="" that="" consideration="" of="" a="" common="" mechanism="" of="" toxicity="" is="" not="" appropriate="" at="" this="" time="" since="" there="" is="" no="" reliable="" information="" to="" indicate="" that="" toxic="" effects="" produced="" by="" pyridaben="" would="" be="" cumulative="" with="" those="" of="" any="" other="" chemical="" compounds.="" h.="" determination="" of="" safety="" for="" u.s.="" population="" using="" the="" exposure="" assumptions="" described="" in="" unit="" i.g.="" of="" this="" document,="" basf="" concludes="" that="" aggregate="" exposure="" to="" pyridaben="" will="" utilize="" approximately="" 11.3="" percent="" of="" the="" rfd="" for="" the="" u.s.="" population.="" epa="" generally="" has="" no="" concern="" for="" exposures="" below="" 100="" percent="" of="" the="" rfd.="" therefore,="" based="" on="" the="" completeness="" and="" reliability="" of="" the="" toxicity="" data="" and="" the="" conservative="" exposure="" assessment,="" basf="" concludes="" that="" there="" is="" a="" reasonable="" certanity="" that="" no="" harm="" will="" result="" from="" aggregate="" exposure="" to="" residues="" of="" pyridaben,="" including="" all="" anticipated="" dietary="" exposure="" and="" all="" other="" non-occupational="" exposures.="" i.="" determination="" of="" safety="" for="" infants="" and="" children="" developmental="" toxicity="" (delayed="" ossification)="" was="" observed="" in="" developmental="" toxicity="" studies="" using="" rats="" and="" rabbits.="" the="" noel's="" for="" developmental="" effects="" were="" established="" at="" 13="" mg/kg/day="" in="" the="" rat="" study="" and="" 15="" mg/kg/day="" in="" the="" rabbit="" study.="" the="" developmental="" effect="" observed="" in="" these="" studies="" is="" believed="" to="" be="" a="" secondary="" effect="" resulting="" from="" maternal="" stress="" (decreased="" body="" weight="" gain="" and="" food="" consumption).="" in="" a="" 2-generation="" reproduction="" study="" in="" rats,="" pups="" from="" the="" high="" dose="" group,="" which="" were="" fed="" diets="" containing="" 80="" ppm="" (equivalent="" to="" 6.31="" and="" 7.82="" mg/kg/day="" in="" male="" and="" females,="" respectively)="" gained="" less="" weight="" beginning="" on="" lactation="" day="" 14.="" parental/systemic="" toxicity="" including="" decreased="" body="" weights,="" body="" weight="" gains="" and="" food="" efficiency="" in="" males,="" and="" slightly="" decreased="" body="" weights="" and="" body="" weight="" gains="" in="" females="" during="" lactation="" was="" also="" observed="" in="" the="" high="" dose="" group.="" the="" results="" of="" this="" study="" indicate="" that="" the="" loss="" in="" weight="" gain="" in="" pups="" from="" the="" high="" dose="" group="" was="" affected="" by="" nursing.="" no="" clear="" scientific="" consensus="" yet="" exists="" to="" determine="" the="" most="" appropriate="" endpoints="" for="" assessing="" risk="" in="" children.="" however,="" in="" consideration="" of="" the="" data="" that="" show="" both="" developmental="" and="" reproductive="" toxicity="" were="" effects="" secondary="" to="" parental="" toxicity,="" basf="" believes="" that="" the="" established="" rfd="" of="" 0.005="" mg/kg/day="" is="" the="" most="" conservative="" approach="" for="" assessing="" risk="" in="" children.="" using="" the="" exposure="" assumptions="" described="" in="" unit="" i.g.="" of="" this="" document,="" basf="" has="" concluded="" that="" the="" percent="" of="" the="" rfd="" that="" will="" be="" utilized="" by="" aggregate="" exposure="" to="" residues="" of="" pyridaben="" from="" the="" proposed="" use="" in="" citrus,="" apples,="" pears,="" almonds,="" peaches,="" plums,="" and="" grapes="" is="" approximately="" 73.4="" percent="" for="" non-nursing="" infants=""><1 year),="" the="" most="" sensitive="" sub-population.="" based="" on="" the="" completeness="" and="" reliability="" of="" the="" toxicity="" data="" and="" the="" conservative="" exposure="" assessment,="" basf="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" in="" infants="" and="" children="" from="" aggregate="" exposure="" to="" the="" residues="" of="" pyridaben,="" including="" all="" anticipated="" dietary="" exposure="" and="" all="" other="" non-occupational="" exposures.="" j.="" other="" considerations="" the="" qualitative="" nature="" of="" the="" residues="" in="" plants="" and="" animals="" is="" adequately="" understood.="" residues="" of="" the="" parent="" molecule,="" pyridaben="" are="" the="" only="" residues="" of="" concern.="" residues="" of="" pyridaben="" do="" not="" concentrate="" in="" the="" processed="" commodities="" apple="" and="" citrus="" juice.="" there="" is="" a="" practical="" analytical="" method="" for="" detecting="" and="" measuring="" levels="" of="" pyridaben="" in="" or="" on="" food="" with="" a="" limit="" of="" detection="" that="" allows="" monitoring="" of="" food="" with="" residues="" at="" or="" above="" the="" levels="" set="" in="" these="" tolerances.="" [[page="" 11453]]="" k.="" international="" tolerances="" a="" maximum="" residue="" level="" has="" not="" been="" established="" for="" pyridaben="" by="" the="" codex="" alimentarius="" commission.="" ii.="" public="" record="" epa="" invites="" interested="" persons="" to="" submit="" comments="" on="" this="" notice="" of="" filing.="" comments="" must="" bear="" a="" notification="" indicating="" the="" docket="" control="" number="" [pf-721].="" all="" written="" comments="" filed="" in="" response="" to="" this="" petition="" will="" be="" available,="" in="" the="" public="" response="" and="" program="" resources="" branch,="" at="" the="" address="" given="" above="" from="" 8:30="" a.m.="" to="" 4="" p.m.,="" monday="" through="" friday,="" except="" legal="" holidays.="" a="" record="" has="" been="" established="" for="" this="" notice="" under="" docket="" control="" number="" [pf-721]="" (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="" public="" record="" is="" located="" in="" rm.="" 1132="" of="" the="" public="" response="" and="" program="" resources="" branch,="" field="" operations="" division="" (7506c),="" office="" of="" pesticide="" programs,="" environmental="" protection="" agency,="" crystal="" mall="" #2,="" 1921="" jefferson="" davis="" highway,="" arlington,="" va.="" 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. The official
record for this notice, as well as the public version, as described
above, will be kept in paper form. Accordingly, EPA will transfer all
comments received electronically into printed, paper form as they are
received and will place the paper copies in the official record which
will also include all comments submitted directly in writing. The
official record is the paper record maintained at the address in
``ADDRESSES'' at the beginning of this document.
Authority: 21 U.S.C. 346a.
List of Subjects
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: March 6, 1997.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 97-6209 Filed 3-11-97; 8:45 am]
BILLING CODE 6560-50-F
