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captafol (Difolatan) Decision to Terminate Special Review 8/88

Captafol; Decision to Terminate Special Review for Pesticide
Products Containing Captafol--Federal Register Notice, August
31, 1988 Issued

AGENCY:  Environmental Protection Agency (EPA)

ACTION:  Notice:  decision to terminate special review.


SUMMARY:  On July 22, 1987, EPA issued a Proposed Decision to Terminate a
Special Review for Pesticide Products Containing Captafol.  This action was
based on the fact that the Agency had issued cancellation letters to all
registrants of captafol products on May 1, 1987, in response to registrant
requests.  All cancellations were effective April 30, 1987.  Since there
are no remaining registrations for captafol, the Agency has determined that
continuing the Special Review is unnecessary.  With this Notice, the agency
is publicly announcing its decision to terminate the Special Review of
captafol.

EFFECTIVE DATE:  August 31, 1988.

FOR FURTHER INFORMATION CONTACT:

By Mail:  Karis L  North, Special Review Branch, Registration Division (TS-
767C), Office of Pesticide Programs, Environmental Protection Agency,
401 M St. SW., Washington, DC 20460.

Office Location and Phone Number:  Room 1006, Crystal Mall #2, 1921
Jefferson Davis Highway, Arlington, VA 22202, (703) 557-7400.

Supplementary Information:
 
Unit I.  Introduction and Background
 
Captafol was registered as a fungicide for the control of foliar and
fruit diseases of certain fruits and vegetables and peanuts.  It was also
registered for application to seeds of corn, cotton, peanuts, rice and
sorghum; to pineapple planting stock as a preplant treatment; and to wood 
as a preservative treatment.
 
Captafol was manufactured as a 97 percent technical solely by Chevron
Chemical Company.  Captafol registrations are also held by the University 
of Hawaii and Osmose Wood Preserving, Inc., as formulators of the product.
Captafol was an ingredient in 16 products registered under section 3 of the
Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) as amended
September 30, 1978.  It was also used in 19 products registered under 
section 24(C), and in intrastate product pending registrations.
 
On January 9, 1985, the Agency issued a notice in the Federal Register
(50 FR 1103) initiating a Special Review of captafol pursuant to 40 CFR
154.7(a), based on Agency concerns over data showing that captafol causes
oncogenic effects in laboratory animals and is highly toxic to fish.
Following initiation of the Special Review, the three registrants of 
Captafol products, Chevron Chemical Company, Osmose Wood preserving, Inc., 
and the University of Hawaii requested voluntary cancellation.  In response 
to these requests for voluntary cancellation of captafol product 
registrations, the Agency, on May 1, 1987, issued cancellation letters to 
each of the registrants, which outlined the terms of the cancellation.  
Therefore, as of April 30, 1987, the effective date of the cancellation, 
there was no longer any active United States pesticide registrations for 
captafol.
 
Since there are no remaining registrations for products containing
captafol, on July 22, 1987, the Agency issued a Proposed Decision to 
Terminate a Special Review for Pesticide Products Containing Captafol.  The 
30 day comment period provided for in that notice has expired.  One set of 
comments in response to the Notice were submitted to the Agency; those 
comments are addressed herein.
 
Unit II.  Comments, Agency Response to Comments and Agency Decision
 
The only set of comments received in response to the notice of intent to
terminate the Special Review of pesticide products containing captafol was
submitted by Chevron Chemical Company, the sole United States registrant of
technical captafol.
 
Chevron Comment:  "The first statement of concern appears under Part III
C, Risk Reduction Measures and Regulatory Status.  The error is in 
reference to 'the World Health Organization, which banned the use of 
captafol on all food crops.'  WHO is not a regulatory agency, therefore it 
does not have the authority to ban products.  It is true that in September, 
1985 the Joint FAO/WHO Meeting on Pesticide Residues (JMPR), acting under 
the auspices of WHO, withdrew the captafol. Acceptable Daily Intake (ADI) 
and recommended that captafol not be used where residues in food could 
arise but even this action was advisory only."
 
EPA Response:  The Agency agrees that WHO is not a regulatory
organization.  However, concern about the carcinogenicity of captafol
influenced the JMPR, acting under the auspices of WHO to recommend 
withdrawal of the ADI for captafol.  Consequently, the use of captafol in 
international markets has been severely limited.
 
Chevron Comments:  "The second statement appears under Part V, Agency's
Decision Regarding Special Review.  The error is in the sentence which ends
'the sale of existing stocks of captafol in the United States is allowed 
only until December 31, 1987.'  Please refer to the Agency's May 12, 1987 
response to Chevron's request for voluntary cancellation.  The letter 
states that the registrant may not sell captafol after December 31, 1987, 
but that 'Other persons may continue to distribute and sell and use 
existing stocks of these product(s) until the supply is exhausted."
 
EPA Response:  The Agency agrees with the comment.  The existing stocks
provision was specified in the Agency's letter of May 1, 1987 and as stated 
in Chevron's comment is correct.  Identical letters were sent to each 
captafol registrant.
 
The Agency has concluded that neither of these comments have a bearing
on whether to terminate the Special Review.  Therefore, the Agency has not
altered its view regarding the termination of the Special Review.
 
Decision:  Accordingly, this notice is being issued to publicly announce
the Agency's decision to terminate the Special Review of pesticide products
containing captafol.  The decision is effective upon the date of signature 
of this Notice.
 
Unit III.  Availability of Public Docket
 
The Agency has established a public docket (OPP-30000/43B) for the
captafol Special Review.  This public docket will include this Notice; any
other Notices pertinent to the captafol Special Review and the Agency's
decision regarding the termination of the Special Review of captafol; non-
CBI documents and copies of written comments or other materials submitted 
to the Agency in response to the initiation of the Special Review and the 
notice of intent to terminate the Special Review; and a current index of 
materials in the public docket.
 
Dated:L  August 22, 1988.
 
Victor J> Kimm,
Assistant Administrator for Pesticides and Toxic Substances.
 
FR Doc. 88-019794 Filed 80-30-88; 8:45 am.
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