[Federal Register Volume 62, Number 95 (Friday, May 16, 1997)]
[Notices]
[Pages 27025-27027]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-12914]
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ENVIRONMENTAL PROTECTION AGENCY
[PF-735; FRL-5717-8]
American Cyanamid Company; Pesticide Tolerance Petition Filing
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces the initial filing of a pesticide
petition proposing the establishment of regulations for residues of a
certain pesticide chemical in or on various food commodities.
DATES: Comments, identified by the docket control number PF-735, must
be received on or before June 16, 1997.
ADDRESSES: By mail submit written comments to: Public Response and
Program Resources Branch, Field Operations Divison (7505C), Office of
Pesticides Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. In person bring comments to: Rm. 1132, CM #2,
1921 Jefferson Davis Highway, Arlington, VA.
Comments and data may also be submitted electronically by following
the instructions under ``SUPPLEMENTARY INFORMATION.'' No confidential
business information should be submitted through e-mail.
Information submitted as a comment concerning this document may be
claimed confidential by marking any part or all of that information as
``Confidential Business Information'' (CBI). CBI should not be
submitted through e-mail. Information marked as CBI will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2. A copy of the comment that does not contain CBI must be submitted
for inclusion in the public record. Information not marked confidential
may be disclosed publicly by EPA without prior notice. All written
comments will be available for public inspection in Rm. 1132 at the
address given above, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays.
FOR FURTHER INFORMATION CONTACT: Amelia M. Acierto, Registration
Support Branch, Registration Division (7505W), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location, telephone number, and e-mail address: Rm. 4-
W60, Crystal Station #1, 2800 Jefferson Davis Highway, Arlington, VA
22202, (703) 308-8375; e-mail: acierto.amelia@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA has received a pesticide petition as
follows
[[Page 27026]]
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-735] (including comments and data submitted
electronically as described below). A public version of this record,
including printed, paper versions of electronic comments, which does
not include any information claimed as CBI, is available for inspection
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The official record is located at the address in
``ADDRESSES'' at the beginning of this document.
Electronic comments can be sent directly to EPA at:
opp-docket@epamail.epa.gov
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption. Comment and data
will also be accepted on disks in Wordperfect 5.1 file format or ASCII
file format. All comments and data in electronic form must be
identified by the docket number PF-735 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: May 7, 1997.
James Jones,
Acting Director, Registration Division, Office of Pesticide Programs.
Summaries of Petitions
Petitioner summaries of the pesticide petitions are printed below
as required by section 408(d)(3) of the FFDCA. The summaries of the
petitions were prepared by the petitioners and represent the views of
the petitioners. EPA is publishing the petition summaries verbatim
without editing them in any way. The petition summary announces the
availability of a description of the analytical methods available to
EPA for the detection and measurement of the pesticide chemical
residues or an explanation of why no such method is needed.
American Cyanamid Company
PP 3E4216
EPA has received a pesticide petition (PP) PP 3E4216 from American
Cyanamid Company, Agricultural Research Division, P.O. Box 400,
Princeton, NJ, 08543-0400. The petition proposes, pursuant to section
408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C.
346a, to amend 40 CFR part 180 to exempt the residues of 2,2'-(1,2-
ethenediyl)bis[5-[[4-[bis(2-hydroxyethyl)amino]-6-phenylamino]-1,3,5-
triazin-2-yl]amino]-benzenesulfonate from the requirement of a
tolerance when used as inert ingredient (adjuvant and UV absorber/
protectant) in pesticide formulations applied to growing crops. 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
determined whether the data supports granting of the petition.
Additional data may be needed before EPA rules on the petition.
The petitioner is proposing the exemption from the requirement of a
tolerance for 2,2'-(1,2-ethenediyl)bis[5-[[4-[bis(2-
hydroxyethyl)amino]-6-phenylamino]-1,3,5-triazin-2-yl]amino]-
benzenesulfonate (CAS Reg. No. 4404-43-7), a stilbene fluorescent
whitening agent (FWA), to be used as an inert ingredient in
biopesticide formulations intended for use on food and/or feed crops.
USDA has patented the use of FWAs as adjuvants in pesticide
formulations (U.S. Patent No. 5,124,149) and the petitioner has
submitted an application to license this technology. The petitioner
states that FDA has previously approved the use of related stilbenes
(4,4'-bis(2-benzoxazolyl)stilbene, CAS Reg. No. 1533-45-5; 4-(2-
benzoxazolyl)-4'-(5-methyl-2-benzoxazolyl)stilbene, CAS Reg. No. 5242-
49-9; and 4,4'-bis(5-methyl-2-benzoxazolyl)stilbene, CAS Reg. No. 2397-
00-4) as indirect food additives for use in food-contact polymers [21
CFR 178.3297].
A. Residue Chemistry
The petitioner notes that the nature and magnitude of the residue
and analytical methods to determine residue levels are not required by
EPA at this time. The favorable toxicology profile of 2,2'-(1,2-
ethenediyl)bis[5-[[4-[bis(2-hydroxyethyl)amino]-6-phenylamino]-1,3,5-
triazin-2-yl]amino]-benzenesulfonate and other FWAs in combination with
a negligible increase in expected exposure from the proposed use as an
inert ingredient in biopesticides amounts to an insignificant
incremental risk to the public health.
B. Toxicological Profile
The petitioner notes that stilbene fluorescent whitening agents
have been commercially available for nearly 60 years in the textile,
paper and detergent industries and more recently available as FDA-
approved indirect food additives. Thus, an extensive body of reliable
information has been generated on the toxicology of the stilbene class
of chemistry. This complete data base has been developed by industry,
academia, and government agencies both in the United States and
overseas and can be found in numerous publications on FWAs. The
petitioner provides the following toxicological data in support of the
submission:
The acute oral LD50 in rats for 2,2'-(1,2-
ethenediyl)bis[5-[[4-[bis(2-hydroxyethyl)amino]-6-phenylamino]-1,3,5-
triazin-2-yl]amino]-benzenesulfonate reported in the literature is
14,500 mg/kg body weight while the acute dermal toxicity is reported to
be > 2,000 mg/kg body weight in rabbits. In a single 4 hour exposure
acute inhalation study with a related stilbene, no sign of intoxication
or mortality to rats at a concentration of 1.65 mg/L was determined
(LC50 >1.65 mg/L).
In 2-year chronic feeding studies with a related FWA compound, a 40
ppm no observable adverse eEffect level [NOAEL] was established for the
rat based upon slightly increased female mortality (unsupported by
pathological findings) and a 2,000 ppm NOAEL (highest dose tested) was
established for the dog. Additionally, the United States Department of
Health and Human Services' National Toxicology Program technical report
(TR 412) of 2-year toxicology and carcinogenesis studies using a
related stilbene compound concluded there was no evidence of
carcinogenic activity attributed to the molecule when fed to rats and
mice at up to 25,000 ppm and 12,500 ppm, respectively.
Based on a review of available data, the petitioner believes that
FWAs are not genotoxic, not carcinogenic, and do not cause reproductive
or developmental effects when tested in
[[Page 27027]]
mammals and that there is also no evidence to suggest that FWAs exhibit
estrogenic properties.
C. Aggregate Exposure
The petitioner believes that 2,2'-(1,2-ethenediyl)bis[5-[[4-[bis(2-
hydroxyethyl)amino]-6-phenylamino]-1,3,5-triazin-2-yl]amino]-
benzenesulfonate and stilbene FWAs in general are extensively used as
optical brighteners both domestically and internationally.
Approximately 30 million pounds are used annually in the United States
alone with the majority being used in detergents to enhance the color
of laundered clothing. Other uses of stilbenes include incorporation
into textiles, paper, paint, and plastics (some of which are used in
the food industry). In comparison, the proposed use of 2,2'-(1,2-
ethenediyl)bis[5-[[4-[bis(2-hydroxyethyl)amino]-6-phenylamino]-1,3,5-
triazin-2-yl]amino]-benzenesulfonate as an inert ingredient in
pesticide formulations is not expected to exceed 250,000 pounds
annually (< 1%="" of="" the="" total="" fwa="" use="" in="" the="" united="" states).="" the="" petitioner="" believes="" that="" potential="" routes="" of="" non-occupational="" exposure="" to="" fwas="" currently="" include="" non-dietary="" (i.e.,="" potential="" dermal="" exposure="" via="" contact="" with="" laundered="" clothing)="" and="" dietary="" sources="" (i.e.,="" potential="" consumption="" in="" drinking="" water,="" in="" fish,="" and="" as="" residue="" of="" detergents="" adhering="" to="" dishes="" and="" cutlery)="" and="" consequently,="" the="" proposed="" inert="" ingredient="" use="" of="" 2,2'(1,2-ethenediyl)bis[5-[[4-[bis(2-="" hydroxyethyl)amino]-6-phenylamino]-1,3,5-triazin-2-yl]amino]-="" benzenesulfonate="" is="" not="" expected="" to="" significantly="" increase="" the="" aggregate="" exposure="" to="" fwas.="" d.="" cumulative="" effects="" the="" petitioner="" believes="" that="" data="" show="" that="" the="" diaminostilbene-="" disulfonic="" acid="" class="" of="" fwas="" is="" relatively="" non-toxic="" to="" mammals="" and,="" in="" addition,="" the="" proposed="" use="" of="" 2,2'-(1,2-ethenediyl)bis[5-[[4-[bis(2-="" hydroxyethyl)amino]-6-phenylamino]-1,3,5-triazin-2-yl]amino]-="" benzenesulfonate,="" a="" member="" of="" this="" class="" of="" chemistry,="" will="" not="" significantly="" increase="" the="" us="" population's="" exposure="" to="" fwas.="" thus,="" the="" petitioner="" believes="" that="" there="" is="" no="" expectation="" of="" significant="" incremental="" risk="" due="" to="" the="" use="" of="" 2,2'-(1,2-ethenediyl)bis[5-[[4-="" [bis(2-hydroxyethyl)amino]-6-phenylamino]-1,3,5-triazin-2-yl]amino]-="" benzenesulfonate="" as="" an="" inert="" ingredient="" in="" pesticide="" formulations.="" e.="" safety="" determination="" the="" petitioner="" considered="" that="" toxicology="" studies="" conducted="" with="" 2,2'-(1,2-ethenediyl)bis[5-[[4-[bis(2-hydroxyethyl)amino]-6-="" phenylamino]-1,3,5-triazin-2-yl]amino]-benzenesulfonate="" and="" other="" compounds="" in="" the="" stilbene="" class="" of="" chemistry="" show="" there="" is="" reasonable="" certainty="" that="" no="" harm="" to="" the="" u.s.="" population="" will="" result="" from="" aggregate="" exposure="" to="" fwa="" residue="" including="" all="" anticipated="" dietary="" exposures="" and="" all="" other="" non-occupational="" exposures="" for="" which="" there="" is="" reliable="" information.="" experimental="" investigations="" show="" that="" the="" likelihood="" of="" fwas="" constituting="" a="" danger="" to="" human="" health="" is="" so="" minimal="" as="" to="" be="" completely="" negligible.="" the="" petitioner="" notes="" that="" there="" is="" no="" information="" available="" to="" indicate="" that="" children="" or="" infants="" would="" be="" more="" sensitive="" than="" adults="" to="" any="" toxic="" effect="" associated="" with="" exposure="" to="" 2,2'-(1,2-="" ethenediyl)bis[5-[[4-[bis(2-hydroxyethyl)amino]-6-phenylamino]-1,3,5-="" triazin-2-yl]amino]-benzenesulfonate.="" f.="" international="" tolerances="" there="" are="" no="" codex="" maximum="" residue="" levels="" established="" for="" residues="" of="" 2,2'-(1,2-ethenediyl)bis[5-[[4-[bis(2-hydroxyethyl)amino]-6-="" phenylamino]-1,3,5-triazin-2-yl]amino]-benzenesulfonate="" on="" food="" or="" feed="" crops.="" [fr="" doc.="" 97-12914="" filed="" 5-15-97;="" 8:45="" am]="" billing="" code="" 6560-50-f="">