Captan; Order Denying Objection to Revocation of Feed Additive Regulation
[Federal Register: November 2, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 186
[OPP-300199B/FRL-4910-5]
RIN 2070-AB78
Captan; Order Denying Objection to Revocation of Feed Additive Regulation
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule; Order denying objection to revocation.
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SUMMARY: This Order, pursuant to section 409(f) of the Federal Food,
Drug, and Cosmetic Act (FFDCA) and in accordance with the regulations
in 40 CFR part 178, announces that EPA is denying an objection to a
final rule issued August 4, 1993, that revoked the feed additive
regulation in 40 CFR 186.500 for residues of the pesticide captan in or
on detreated captan-treated corn seed.
DATES: This denial of the objection is effective January 31, 1995. For
purposes of judicial review, the entry of this Order shall be at 1 p.m.
eastern time on November 16, 1994.
FOR FURTHER INFORMATION CONTACT: By mail: Patricia C. Critchlow,
Emergency Response and Minor Use Section (7505W), Registration
Division, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location and telephone number: Sixth Floor, Crystal
Station #1, 2800 Jefferson Davis Hwy., Arlington, VA 22202, (703-308-
7066).
SUPPLEMENTARY INFORMATION: In the Federal Register of August 4, 1993
(58 FR 41430), EPA revoked the feed additive regulation (40 CFR
186.500) for residues of the fungicide captan in or on corn seed at 100
parts per million (ppm). This regulation addressed corn seed that
originally was treated with captan as a seed protectant and was later
``detreated'' by washing or roasting so that the seed could be used as
an animal feed. The basis for the revocation was the absence of residue
data to support the regulation and the lack of adequate control
procedures to ensure seed was detreated properly. On August 27, 1993,
Ken Hunt of Ken's Roasting Service filed objections to that revocation.
This Order denies those objections.
Background
In March 1986, as part of an overall review of captan, EPA
determined that the record contained ``no acceptable residue data to
support the roasting detreatment method at any dosage or period of
storage.'' (Guidance for the Reregistration of Pesticide Products
Containing Captan (March 1986).) The Residue Chemistry Chapter of the
Registration Standard (August 1985) concluded that there were
insufficient data for residues of captan on corn seed that had been
treated at the maximum label rate and then detreated. The only
available data were on residue reduction from washing of treated corn
seed. The then- existing tolerance was exceeded in several samples, the
treatments were not conducted at the maximum label rate, and crucial
details of many of the experiments were missing. The validity of the
data could not be determined, and the data covered only a washing
process. Data were requested on the residues of concern on seed both
before and after detreating. The detreatment methods of interest to the
registrant(s), such as roasting, were to be tested. This information
was essential to establish a proper tolerance and to evaluate the
dietary risk from detreated corn.
EPA announced it would revoke the food additive regulation for
detreated corn seed unless within 1 year the following data and
information were submitted:
1. Data on the residues of concern in or on corn seed treated with
captan at the maximum allowable rate and detreated by an acceptable
process. Data were required on residues of concern both before and
after detreatment. Moreover, EPA made clear that different methods of
detreating would only be permitted under the regulation if data were
presented depicting residues resulting from each method. EPA required
that the data must depict the influence of varying parameters of the
detreating process, such as rate of seed treatment, volume of water
required, temperature employed, etc. Finally, EPA explained that these
data would be used to establish the acceptable conditions for
detreating by each method.
2. An acceptable method for informing corn seed treaters and corn
seed distributors of acceptable methods for detreating captan-treated
corn seed must be proposed.
3. An acceptable handling procedure for captan-treated seed corn
(to be detreated) to assure that there are no other pesticides on the
seed must be proposed.
Because no data or information were submitted over the next 3
years, on August 30, 1989 (54 FR 35897), EPA proposed to revoke the
food additive regulation on the grounds that there were insufficient
data to support it. EPA received several comments opposing the
revocation, but none of the commenters submitted the data requested.
EPA was not convinced by any of the comments that the data were not
necessary and, therefore, on August 4, 1993, it issued a final rule
revoking the tolerance.
On August 27, 1993, Ken Hunt of Ken's Roasting Service, Arcadia,
Nebraska, filed objections to the revocation. Mr. Hunt supplemented his
objections on September 7, 1993. Mr. Hunt's primary objection is that
detreatment of captan-treated seed by roasting is safer than simply
disposing of the seed. As support for this contention, Mr. Hunt claims
that his experience in feeding to his livestock seed that he has
detreated has caused no harm to the livestock or to his family, which
has consumed meat from that livestock. Mr. Hunt also notes that
tolerances for captan on various other crops, such as grapes, are as
high as 50 parts per million (ppm). Mr. Hunt submitted analytic
sampling results from his detreated corn which show that the tested
corn contained low levels of captan (2 ppm or less). Mr. Hunt claims
that he avoids detreating seeds that contain pesticide residues other
than captan by having his trucker check the labels on all seed that is
picked up for detreatment. Finally, Mr. Hunt asks if EPA would allow
him to continue his operation for a few more years because of the
sizable investment he has put into it.
For the reasons below, EPA must deny Mr. Hunt's objections.
Magnitude of residue data, such as were requested here, are critical
data in establishing or supporting tolerances and food additive
regulations for pesticide residues. As EPA's Pesticide Assessment
Guidelines explain, ``[r]esidue chemistry data on processed food/feed
are used by the Agency to estimate the exposure of the general
population to pesticide residues in foods (including animal
commodities) and for setting and enforcing food additive tolerances for
pesticide residues in or on processed food/feed under provisions of
Section 409 of the Federal Food, Drug, and Cosmetic Act.'' (Pesticide
Assessment Guidelines, Subdivision O, Addendum 4, p. 2 [MIS #PB88-
117270, EPA 540/09-88-004 (Nov. 1987)].)
Without magnitude-of-residue data, EPA cannot make accurate
exposure estimates and hence risk estimates also will be inaccurate.
The anecdotal information supplied by Mr. Hunt cannot substitute for
safety evaluations made on the basis of valid scientific data.
Additionally, magnitude-of-residue data allow EPA to establish
enforcement levels in tolerances and food additive regulations that are
representative of the residue levels that will be found under proper
pesticide use patterns. If tolerances and food additive regulations are
set at levels exceeding what could be expected from normal usage, then
pesticide users might be encouraged to apply pesticides without strict
regard to label requirements or not to follow proper detreatment
procedures. If tolerances and food additive regulations are set too
low, then otherwise safe food may be seized by the Food and Drug
Administration or Department of Agriculture.
It is true that several foods have captan tolerances at levels
exceeding the levels Mr. Hunt has reported in his detreated corn, but
those tolerances are supported by residue data and the safety of those
tolerances has been evaluated based on those data, consumption pattern
data, and information on exposure from other uses of captan. If residue
data had been submitted for detreated corn, a similar analysis could
have been performed for the food additive regulation at issue.
The sampling results submitted by Mr. Hunt are no substitute for
the magnitude-of-residue data requested. They represent a single
detreatment method under unspecified conditions. Several summary
analysis reports are given, indicating residues on detreated corn
ranging from less than 0.01 ppm to 2.6 ppm. The analytical methods are
not specified, and no method validation data were included. Moreover,
no data were provided on the same corn prior to detreatment. The data
are of the type that a business might use to monitor quality control in
its process, but the data are totally inadequate for fulfilling residue
chemistry data requirements. Mr. Hunt appears to follow a careful
procedure for not detreating seed containing other than captan
residues, but this alone is not grounds for maintaining the food
additive regulation. Finally, EPA recognizes that Mr. Hunt may have a
sizable investment in his operation, but tolerances and food additive
regulations are rules of national application, and Mr. Hunt's
investment cannot justify maintaining the legality of these pesticide
residues nationwide.
Accordingly, the objections are denied. This Order is issued under
FFDCA section 409(f) and is subject to judicial review as provided in
FFDCA section 409(g).
Dated: September 26, 1994.
Lynn R. Goldman,
Assistant Administrator for Prevention, Pesticides and Toxic
Substances.
[FR Doc. 94-26805 Filed 11-1-94; 8:45 am]
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