[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: [email protected].
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:
    [email protected]


    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