[Federal Register Volume 61, Number 40 (Wednesday, February 28, 1996)]
[Notices]
[Pages 7508-7509]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-4252]



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ENVIRONMENTAL PROTECTION AGENCY
[OPP-30000/59A; FRL-4979-8]


Propoxur; Decision Not to Initiate a Special Review

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This Notice announces EPA's decision not to initiate a Special 
Review for the insecticide propoxur (Baygon, Sendran; 2-isopropoxy-
phenyl-N-methylcarbamate). Propoxur was being considered for Special 
Review because of potential carcinogenic risks to applicators and home 
residents from the registered uses. After evaluating new exposure and 
carcinogenicity data, and in light of voluntary cancellation and label 
amendment actions which eliminated those uses posing the greatest 
concern, EPA believes that the estimated risks do not warrant 
initiation of a Special Review.

FOR FURTHER INFORMATION CONTACT: By mail: Monica F. Spann, Special 
Review Branch, Special Review and Reregistration Division (7508W), 
Office of Pesticide Programs, Environmental Protection Agency, 401 M 
St., SW., Washington, DC 20460. Office location, telephone number, and 
e-mail address: Special Review Branch, 3rd Floor, Crystal Station #1, 
2800 Crystal Drive, Arlington, VA, Telephone: 703-308-8032, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of January 13, 1995 
(60 FR 3210), EPA announced its proposed decision (and solicitation for 
public comment) not to initiate a Special Review of propoxur based on 
carcinogenic risks posed to applicators and home residents. The Agency 
has received one comment from the sole registrant, Bayer Corporation, 
and decided to maintain the decision not to initiate a Special Review. 
This notice provides the Agency's final decision, its response to 
comment, and the rationale for its final decision. For more detailed 
information, see 60 FR 3210.

I. Introduction

    Propoxur (2-isopropoxy-phenyl-N-methylcarbamate) is a carbamate 
insecticide for the control of insects and other arthropods inside and 
outside of buildings and on pets. The holders of 

[[Page 7509]]
the two U.S. technical registrations of propoxur, Baygon and Sendran, 
are Bayer Corporation, Agriculture Division, and Bayer Corporation, 
Animal Health Division, respectively. Bayer Corporation was formerly 
known as Miles Incorporated. Bayer Corporation is a subsidiary of 
Bayer, AG, Germany.
    On March 22, 1988, pursuant to 40 CFR 154.21(a), EPA issued a 
private (``Grassley-Allen'') notification to propoxur registrants that 
the Agency was considering a Special Review of propoxur. EPA was 
concerned with propoxur's potential cancer risk to applicators when 
applying indoors and outdoors, to occupants of treated buildings, and 
to those treating pets with propoxur. EPA's concern was based on a 1984 
carcinogenicity study which reported increases in the incidences of 
malignant and benign tumors in the urinary bladders of both male and 
female rats, an increase in incidence of uterine tumors in female rats, 
and the early onset and increased incidence of hyperplasia of the 
urinary bladder in the male and female rats. EPA classified propoxur as 
a Group B2 (probable human) carcinogen. EPA noted that additional data 
submitted to the Agency would be used to refine estimates of risk, and 
that the registrant's responses to this notification would be 
considered in determining whether to initiate a Special Review.

II. Risk Assessment

    Since the issuance of the Grassley-Allen notification, the 
estimated risk from exposure to propoxur was reduced due to a 
recalculated (and lower) cancer potency factor (Q1*) and 
reductions in estimated exposure. While the Agency continues to 
classify propoxur as a B2 (probable human) carcinogen, the estimated 
Q1* was reduced as a result of additional data submitted in 1988. 
Estimated exposure was reduced due to new exposure studies submitted in 
response to the 1987 DCI and better information on compound behavior 
and use practices. Also, some uses for which the Agency had the 
greatest concern were voluntarily cancelled. A detailed discussion of 
the risk assessment for propoxur can be seen in the proposed decision 
not to initiate a Special Review published on January 13, 1995 (60 FR 
3210).

III. Comments

    In the January 13, 1995 proposal not to initiate a Special Review 
on propoxur, the Agency provided a 60-day comment period, which ended 
on March 14, 1995. EPA received one comment from Bayer Corporation, the 
sole registrant, who agreed with the Agency's position.
    Comment: The registrant concurs with the Agency's evaluation of the 
estimation of cancer risks. In their comment, Bayer also addressed the 
Agency's characterization of a proposed food additive regulation (FAR) 
for food handling establishments. Bayer believes that the Agency 
misinterpreted their data by assuming that crack and crevice 
applications result in residues on food and food contact surfaces. 
Bayer stated that the residue data the Agency cited were for a 
combination of spot treatment and crack and crevice application, and 
therefore, does not represent residues that may occur from only crack 
and crevice applications. Furthermore, the registrant claims that there 
is no risk from crack and crevice applications.
    Response: The petition for a FAR for the spot treatment of propoxur 
in food handling areas of food establishments included data 
demonstrating residues of 0.07 parts per million (ppm) on food and/or 
food contact surfaces, but the crack and crevice treatment was made in 
addition to the spot treatment. The data do not permit separation of 
the different applications so that it is apparent which treatment(s) 
resulted in the residues. EPA believes that in order for the registrant 
to substantiate a claim that the crack and crevice treatment does not 
result in residues on food and/or food contact surfaces, additional 
data would need to be submitted to demonstrate this claim. It should be 
noted that because propoxur induces cancer within the meaning of the 
Delaney clause of section 409 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 348(c)(5)), the proposed FAR cannot be established and 
it may not be established with the submission of additional data. The 
Agency mentioned the evaluation of the proposed FAR and related 
cancellation of food handling uses in the proposed decision for 
informational purposes. Any tolerance and related cancellation actions 
will be proposed in a subsequent document or addressed in the 
reregistration process.

IV. EPA's Decision Regarding Propoxur

    The Agency maintains its position that the carcinogenic risks posed 
by currently registered uses of propoxur do not warrant initiation of a 
Special Review.

V. Executive Order 12898

    In accordance with the Executive Order on Environmental Justice, 
EPA has reviewed this proposed decision and found it does not result in 
any adverse environmental effects (including human health, social and 
economic effects) on minority and low-income communities.

    Dated: February 1, 1996.
Lynn R. Goldman,
Assistant Administrator for Prevention, Pesticides and Toxic 
Substances.
[FR Doc. 96-4252 Filed 2-27-96; 8:45 am]
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