[Federal Register Volume 59, Number 71 (Wednesday, April 13, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-8733]


[[Page Unknown]]

[Federal Register: April 13, 1994]


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ENVIRONMENTAL PROTECTION AGENCY
[OPP-30000/48E; FRL-4770-2]

 

Granular Carbofuran; Proposed Decision to Deny FMC Corp's Request 
for Reinstatement of the Corn and Sorghum Uses; Proposed Decision to 
Grant an Extension of the Phase-Out Period for Use on Rice; Call for 
Reduced Risk Alternatives to Control Rice Water Weevil

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: FMC Corporation and grower groups have requested reinstatement 
of the corn and sorghum uses, and extension of the phase-out period for 
the rice use of granular carbofuran. These three uses of granular 
carbofuran are currently being phased out according to the terms of an 
Agreement in Principle between FMC Corp. and EPA that concluded the 
Special Review of granular carbofuran. This notice announces EPA's 
proposed decision to deny FMC's request for reinstatement of the use of 
granular carbofuran on corn and sorghum, and to grant FMC's request for 
an extension to the phase-out period for rice. EPA's proposed decision 
to extend the rice use is subject to 40 CFR 154.35 because the 
extension of use might increase avian risk, which was the basis of the 
Special Review of granular carbofuran. EPA is proposing an extension of 
the use of granular carbofuran on rice because there are currently no 
efficacious alternatives available.
    In conjunction with the proposed extension of the phase-out period 
of granular carbofuran on rice, EPA is encouraging the registration of 
reduced risk alternatives to control rice water weevil. Specifically, 
EPA is asking pesticide manufacturers who are currently developing data 
in support of the rice registration or who are giving consideration to 
pursuing a rice registration in the near future, to inform the Agency 
of their plans. EPA will provide incentives for manufacturers if they 
have adequate data to support their claims of reduced risk. EPA is also 
calling for data on integrated pest management (IPM) strategies and 
non-chemical control methods for rice water weevil.

DATES: Written comments must be submitted by July 12, 1994.

ADDRESSES: By mail submit comments identified by the document control 
number [OPP-30000/48E] to: OPP Docket, Public Response and Program 
Resources Branch, Field Operations Division (7506C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460. In person bring comments identified by document 
control number (OPP-30000/48E) to: OPP Docket, Rm 1132, CM #2, 1921 
Jefferson Davis Highway, Arlington, VA.

FOR FURTHER INFORMATION CONTACT: By mail: Margaret Rice, Special Review 
and Reregistration Division (7508W), Office of Pesticide Programs, U.S. 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. 
Office location and telephone number: Special Review Branch, Rm. 
WF32N4, Crystal Station #1, 2800 Crystal Drive, Arlington, Virginia, 
(703) 308-8039.

SUPPLEMENTARY INFORMATION:

I. Background

    The Special Review of granular carbofuran was initiated in October 
1985 (50 FR 41938), based solely on acute risk to avian species. In 
January, 1989, EPA's Preliminary Determination (54 FR 3744, January 25, 
1989) proposed to cancel all uses based on the finding that the risks 
of granular carbofuran outweighed the benefits of continued use. EPA 
presented its proposed decision for public comment, to the Federal 
Insecticide Fungicide and Rodenticide Act (FIFRA) Scientific Advisory 
Panel (SAP), and to the U. S. Department of Agriculture (USDA). The SAP 
generally supported EPA's avian risk assessment methodology and the 
Agency's proposal to cancel all uses where efficacious alternatives 
were available. USDA provided information related to the use of 
granular carbofuran that EPA subsequently incorporated into its final 
benefits assessment. The ``Granular Carbofuran Conclusion of Special 
Review Technical Support Document,'' available in the OPP Docket, 
contains EPA's detailed response to the SAP, USDA, and public comments 
received in response to EPA's Preliminary Determination.
    While the Agency was preparing to finalize the proposed 
cancellation, FMC Corporation, the sole registrant of granular 
carbofuran, entered into negotiations with EPA. The result of the 
negotiations was an Agreement in Principle signed on May 13, 1991, 
which provided for phasing out 99 percent of the use of granular 
carbofuran over a 4-year period.
    The conclusion of the granular carbofuran Special Review (56 FR 
64621, December 11, 1991) was based on amendments to the granular 
carbofuran registrations, including geographic restrictions, label 
changes, and phase-out of major uses, submitted to the Agency by FMC 
that implemented the terms and conditions of the Agreement in 
Principle. EPA determined that these amendments brought the risks and 
benefits of granular carbofuran into balance such that the Special 
Review could be concluded.
    The Agreement in Principle provided for the complete phase-out of 
granular carbofuran use by September 1, 1994, with the exception of 
five crops where minor amounts are used. Thus, pursuant to the 
Agreement in Principle, corn and sorghum were deleted from the granular 
carbofuran labels effective September 1, 1993. FMC has amended its 
label to delete the rice use effective September 1, 1994. The Agreement 
provides that beginning September 1, 1994, granular carbofuran will be 
labeled for use only on the following sites: bananas (in Hawaii only), 
cucurbits (pumpkins, cucumbers, watermelons, cantaloupes, and squash), 
dry-harvested cranberries, pine progeny tests, and spinach grown for 
seed.
    No more than a total of 4.5 million pounds of active ingredient 
(ai) in granular formulation was to have been sold in the United States 
between September 1, 1991 and August 31, 1994, with an additional limit 
of no more than 400,000 pounds ai to be sold between September 1, 1993 
and August 31, 1994.
    Remaining stocks of granular carbofuran in the hands of growers and 
distributors labeled for use on corn and sorghum may be sold and used 
until September 1, 1994, i.e., 1 year after the deletions of those uses 
from the registrations. Similarly, granular carbofuran labeled for use 
on rice, in the possession of growers and distributors, may be used 
until September 1, 1995.
    FMC submitted label amendments embodying the terms and conditions 
of the Agreement in Principle. EPA published a notice (56 FR 33286) 
pursuant to section 6 (f) of FIFRA announcing the schedule for deletion 
of granular carbofuran uses on July 19, 1991.
    The Agreement in Principle stipulated that EPA would provide FMC 
with the opportunity for a meeting with the Director of the Office of 
Pesticide Programs regarding the risks and benefits of the corn, 
sorghum and rice uses of granular carbofuran prior to the effective 
dates of deletion of those uses from the label. FMC met with EPA on 
October 6 and 12, 1993, to present information in support of 
reinstating the corn and sorghum uses and extending the phase-out 
period of the rice use. All materials submitted by FMC as well as 
minutes of the October 6th and 12th meetings can be found in the OPP 
Docket. EPA has reviewed the material presented by FMC and other 
interested parties related to these three uses as input to this 
proposed decision.
    Granting any of FMC's requests would necessitate modification to 
the terms and conditions of the granular carbofuran registrations that 
were agreed upon by EPA and FMC, and that provided the basis for 
conclusion of the Special Review. Although EPA's proposed decision to 
deny FMC's request for modification that would allow additional use of 
granular carbofuran on corn and sorghum does not represent a change to 
the terms and condition of the registration, EPA is, nonetheless, 
offering a final opportunity for growers and others affected by the 
decision to come forward with relevant information.

II. Arguments Put Forth by FMC in Support of Continued Use of 
Granular Carbofuran on Corn, Sorghum, and Rice

    Materials submitted by FMC in support of their request to continue 
the use of granular carbofuran on corn, sorghum, and rice are available 
for public viewing in the OPP Public Docket. These materials include 
minutes of the October 6 and 12 meetings with EPA. In its submissions, 
FMC contends that, in terms of benefits:
    1. Taking into account changes to the 1990 Farm Bill would 
significantly increase benefits estimates.
    2. Annual economic impacts due to the loss of granular carbofuran 
for corn and sorghum are considerably higher than EPA estimated in the 
Final Benefits Analyses.
    3. The use of granular carbofuran provides indirect benefits of $50 
to $100 million per year in hunting and recreational revenue, resulting 
from waterfowl habitat preservation in rice growing areas.
    In terms of risks, FMC contends that:
    1. EPA's previous avian risk assessment was inadequate to determine 
the impact of granular carbofuran on bird populations. FMC submitted a 
protocol for a study intended to assess the probability of adverse 
effects from the use of granular carbofuran on populations of local and 
migratory bird species.
    2. No additional kill incidents have occurred since 1991 from 
granular carbofuran used at planting on corn, sorghum, or rice. 
Relatively few bird kill incidents have occurred considering the more 
than 20 years of granular carbofuran use.
    3. Cluster analysis would show granular carbofuran relatively low 
in risk compared to alternatives, if all risk endpoints were 
considered.

III. Other Public Comments Received After the Conclusion of the 
Special Review

    In addition to the material submitted by FMC, EPA has received and 
considered information from others affected by the phase-out of 
granular carbofuran. These comments are summarized below.
    In a letter to EPA dated March 10, 1992, the U.S. Fish and Wildlife 
Service (FWS) supported EPA's decision to phase-out most uses of 
granular carbofuran, because the phase-out was likely to prevent the 
deaths of untold numbers of migratory birds in the United States each 
year. However, FWS also indicated that they believed that there are no 
conditions under which granular carbofuran can be used without 
presenting unreasonable risk. The FWS supported full cancellation of 
all pesticide products containing carbofuran. The FWS letter stated 
that the continued registration of carbofuran poses conflict with 
several Federal wildlife statutes including the Migratory Bird Treaty 
Act, the Bald and Golden Eagle Protection Act, and the Endangered 
Species Act. An attachment to the letter listed additional bird kill 
incidents, many not previously reported to EPA.
    EPA received numerous letters from Senators and Congressmen from 
corn, sorghum, and rice producing states supporting continued use. EPA 
received one letter from the National Corn Growers Association in 
support of continued use on corn.
    The National Grain Sorghum Producers submitted a letter with 
extension bulletins attached, and subsequently met with EPA on 
September 20, 1993 to outline the importance of several chemicals, 
including carbofuran, to grain sorghum production.
    The U.S. Rice Environmental Committee met with the Agency on June 
18, 1992. They subsequently submitted a package to EPA that included: 
An analysis of potential chemical and non-chemical alternatives for 
control of rice water weevil; letters from State agencies, regional and 
National wildlife organizations attesting to improvement in application 
procedures and product stewardship to mitigate avian risk and the 
importance of rice fields as wildlife habitat; and letters from 
individuals and grower cooperatives attesting to the economic benefits 
of granular carbofuran use.
    Letters from the California Environmental Protection Agency and the 
California Department of Fish and Game specifically support the U.S. 
Rice Environmental Committee's position to retain the use of granular 
carbofuran on rice. Letters from the Louisiana Department of Wildlife 
and Fisheries, the Mississippi Department of Wildlife, Fisheries and 
Parks, the Missouri Department of Conservation, and the FWS Wildlife 
and Habitat Management Office in St. Charles, Arkansas emphasized the 
importance of rice lands as habitat for migratory waterfowl, but did 
not state a position on the continued use of granular carbofuran.
    It should be noted that during the comment period for the 
Preliminary Determination, many local, State, and National wildlife 
organizations wrote in support of EPA's proposal to ban all uses of 
granular carbofuran. These include the National Wildlife Federation, 
Defenders of Wildlife, the Rachel Carson Council, the International 
Crane Foundation, and the Canadian Wildlife Service. The National 
Audubon Society, favored immediate suspension for all uses except rice. 
They expressed concern about the possible effect of cancellation on 
wildlife habitat in California.
    EPA received letters from the following State wildlife and resource 
agencies in support of the Preliminary Determination to cancel granular 
carbofuran: the Indiana Department of Natural Resources, the Virginia 
Department of Natural Resources, the Oklahoma Department of Wildlife 
Conservation, the Florida Game and Fresh Water Fish Commission, the 
Minnesota State Department of Natural Resources, the Louisiana Wildlife 
Federation, the Arizona Game and Fish Department, the Montana 
Department of Fish, Wildlife and Game, the North Carolina Wildlife 
Resources Commission, the Georgia Department of Natural Resources, the 
Arizona Game and Fish Department, the Missouri Department of 
Conservation, and the Kansas Department of Wildlife and Parks.

IV. EPA Response

    EPA's detailed response to issues raised by FMC and other 
commentors is contained in a memo titled, ``Analysis and Recommendation 
RE: FMC's Proposal to Reinstate the Use of Granular Carbofuran on Corn, 
Sorghum, and Rice.'' The memo is available in the OPP Docket. With 
respect to benefits, major points are summarized as follows:
    1. Changes in agricultural policy, specifically to crop support 
programs, have been significant since EPA and others initially 
evaluated the benefits of granular carbofuran use. However, the higher 
benefits estimates generated by FMC are primarily attributable to their 
claim of large yield loss estimates for corn and sorghum. EPA finds 
insufficient evidence in FMC's submission to support FMC's high yield 
loss estimates.
    2. FMC's economic analyses for corn and sorghum did not consider 
all available alternatives or all available efficacy data. In both 
cases, limited regional impacts were presented as national. For the 
sorghum analysis, FMC used the least effective alternative to calculate 
potential losses. All of these factors contributed to the higher 
estimates used by FMC.
    3. EPA did not consider indirect benefits from hunting revenue, 
because these benefits are not unique to carbofuran. FMC's estimate of 
$50 to $100 million is exaggerated due to their use of several 
implausible assumptions regarding the use of economic multipliers and 
the relationship between granular carbofuran treated rice fields and 
total waterfowl habitat.
    With respect to risk, major points are summarized as follows:
    1. EPA's risk assessment did not emphasize impacts on bird 
populations. EPA's concern with granular carbofuran is based on its 
high acute toxicity to birds, field studies, and incident reports 
documenting widespread and repeated mortality to many species of birds, 
including eagles, hawks and other predators. Incidents of both primary 
and secondary poisonings have been observed and documented in many 
different geographic areas, associated with many different use sites, 
and under varying environmental conditions. Legal precedent exists for 
pesticide regulatory decisions based on recurrent kills as an 
unreasonable adverse effect (Ciba-Geigy Corp. v. EPA, 847 F.2d 277, 5th 
Cir. 1989).
    2. FMC has not provided documentation of systematic monitoring of 
specific use sites to substantiate claims of reduced avian risk and 
elimination of kill incidents. Only letters of a testimonial nature 
have been provided. Six additional wildlife kill incidents have been 
reported to EPA since the conclusion of the Special Review in 1991. 
Species killed include a bald eagle, Canada geese, and red-tailed 
hawks.
    3. EPA's assessment did address the comparative risk of 
alternatives in the 1991 Technical Support Document for the conclusion 
of the Special Review.

V. EPA's Proposed Decision on Corn and Sorghum

    EPA finds no basis for reinstating either the corn or sorghum uses 
in the information provided by FMC and other commentors. EPA disagrees 
with the assumptions supporting FMC's claims of yield losses higher 
than those estimated by the Agency. FMC did not consider all available 
alternatives nor did they include all available efficacy data in their 
analysis. In its Final Benefits Analysis for Sorghum, EPA found that 
there are efficacious alternatives available for all corn and sorghum 
uses, except for a very limited area of Nebraska during high chinchbug 
infestation years. These findings are based on efficacy tests conducted 
by universities and state agricultural agencies. Material presented by 
sorghum growers contained no actual data to substantiate claims of high 
anticipated yield losses.
    No new data or information has been put forth that would 
substantively change the risk/benefit decision that formed the basis 
for the Agreement in Principle. Therefore, EPA proposes to deny FMC's 
request to reinstate the corn and sorghum uses of granular carbofuran.
    Pursuant to 40 CFR 154.35, EPA is not required to solicit comment 
on this decision to deny FMC's request for reinstatement of the corn 
and sorghum uses, since this decision would not modify the previous 
Agreement in Principle between FMC and EPA that concluded the Special 
Review. Because individuals affected by this decision have come forward 
and indicated that they were unaware that granular carbofuran would no 
longer be available for use on corn and sorghum in 1994, EPA will 
consider additional, new, and relevant data submitted to the Agency 
during the comment period for this notice. EPA is providing this 
additional comment period even though public comment on the decision to 
cancel all uses of granular carbofuran has been solicited previously in 
the Special Review Preliminary Determination (54 FR 3744). EPA 
responded to comments received at that time in the ``Granular 
Carbofuran Conclusion of the Special Review Technical Support 
Document'' available in the OPP Docket. EPA requests that any 
additional comments be focused on new and substantive data. See unit 
IX, of this notice, for a discussion of the specific data that are most 
useful to EPA.

VI. EPA Proposed Decision on Rice

    EPA is proposing an extension to the current phase-out schedule for 
granular carbofuran use on rice because there are still no registered 
alternative chemical controls for rice water weevil, and there are 
currently no applications in the registration pipeline for this use. 
The absence of alternatives was a consideration in the decision that 
concluded the Special Review and continues to be of concern to the 
Agency.
    EPA is also concerned that non-chemical control options, 
specifically draining fields and eliminating vegetation on field edges 
(clean farming), may not provide effective control of rice water weevil 
and may compromise wildlife habitat initiatives that conservation 
groups have implemented with rice growers. EPA is soliciting additional 
data on these practices and on other pest control strategies that could 
reduce use of granular carbofuran while at the same time maintaining or 
enhancing wildlife habitat in rice growing areas.
    EPA is proposing a maximum 2 year extension to the current phase-
out schedule for the use of granular carbofuran on rice. The Agency 
notes that the current phase-out schedule has already allowed 
substantial time for the development and implementation of alternative 
control methods, since the issuance of the Preliminary Determination in 
1989.
    EPA further proposes that any extension of the use of granular 
carbofuran on rice be subject to the following conditions:
    1. Production and sales by FMC will be limited to 250,000 pounds of 
active ingredient (ai) sold in granular formulations per year for the 
1995 and 1996 use seasons for use on rice and the five minor uses 
stipulated in the Agreement in Principle. FMC must direct 2,500 pounds 
of the total 250,000 pounds ai to the areas where the five minor use 
crops are grown during the 1995 and 1996 use seasons. For the purpose 
of the proposed extension, the 1995 ``use season'' begins September 1, 
1994 and ends August 31, 1995. Similarly, the 1996 use season begins 
September 1, 1995 and ends August 31, 1996.
    2. Existing stocks in the possession of dealers and growers may be 
used on rice until September 1, 1997.
    3. Production and sales by FMC will be limited to 2,500 pounds ai 
per year for use only on the five sites stipulated in the Agreement in 
Principle for 1997 and subsequent years.
    4. No production and sales by FMC will be allowed for use on rice 
during the 1996 growing season, however, if a FIFRA section 3 
registration for an alternative to control rice water weevil appears 
imminent at the end of the 1995 growing season. On or before September 
1, 1995, EPA will assess the prospect for registration of alternatives 
to control rice water weevil and advise FMC and other interested 
parties if production and sales of granular carbofuran for use on rice 
will be allowed for the 1996 growing season. EPA's assessment of the 
registration prospect for alternatives will include: The product's 
efficacy in controlling rice water weevil; the completeness of the data 
base; and, the Agency's finding that the product presents less risk to 
the environment and human health than granular carbofuran.
    5. For each use season, during any period of extension, FMC must 
submit to EPA by October 15, a report containing FMC's granular 
carbofuran production and sales totals for domestic use for the 
immediately preceding use season. FMC will provide EPA with batch 
numbers and keys for granular carbofuran product produced for the 1995 
and 1996 domestic use seasons to facilitate identification of product 
by year.
    6. FMC may be required to implement label changes or other measures 
to reduce avian risk during the period of extension. These may include 
but are not limited to: endangered species bulletins; user education 
and stewardship programs; and, scouting to determine infestation levels 
prior to application.
    The FWS may issue a new Biological Opinion during the 90-day 
comment period for this Notice. The Opinion is the result of an ongoing 
consultation between EPA and FWS regarding the potential of carbofuran 
to adversely affect endangered species. The Opinion or other comments 
from the FWS could influence EPA's decision on extending the use of 
granular carbofuran on rice.
    7. All terms and conditions of the May 1991 Agreement in Principle 
will apply in the case of the extension, except the specific phase-out 
schedule and production limits for the rice use.
    EPA views the proposed extension of the phase-out of granular 
carbofuran on rice as a transitional measure. The U.S. Rice 
Environmental Committee has provided documentation of on-going research 
on both chemical and non-chemical controls for rice water weevil. In 
addition, the Committee has promoted cooperative efforts between rice 
growers and environmental organizations to enhance wildlife habitat in 
rice growing areas. The Agency will make every effort to encourage the 
registration and use of environmentally sound alternative control 
measures for rice water weevil. However, growers and others affected by 
the phase-out of granular carbofuran on rice are advised that EPA has 
already allowed substantial time for the development and adoption of 
alternative pest control methods. For this reason, extensions beyond 
those proposed in this notice are most unlikely. EPA has not changed 
the basic conclusions outlined in the granular carbofuran Special 
Review Final Determination, specifically, that the use of granular 
carbofuran on rice poses unreasonable risk to avian species.

VII. Incentives for Development and Registration of Reduced Risk 
Alternatives to Control Rice Water Weevil

    EPA is committed to reducing risk from pesticide use by eliminating 
or limiting the use of the most dangerous pesticides, promoting the 
registration of reduced risk chemical alternatives, and promoting the 
development and implementation of integrated pest management 
strategies.
    In the case of rice water weevil, EPA notes that many chemicals 
have been tested and shown promise in controlling this pest. However, 
no manufacturers have yet pursued registrations for this use. In order 
to promote registrations of reduced risk alternatives for control of 
rice water weevil, EPA is soliciting letters indicating interest or 
intent to register products for this use, from manufacturers of new 
active ingredients, as well as active ingredients already registered on 
other sites. The Agency encourages registrants who can demonstrate that 
their products present less risk to the environment and human health 
than does the use of granular carbofuran to control rice water weevil 
to come forward now.
    The letters, indicating interest or intent, should provide 
rationale for claims of reduced risk that are organized and presented 
according to the ``Guidelines for Content of Reduced-Risk Rationales'' 
found in Pesticide Regulation (PR) Notice 93-9. The ``Guidelines'' 
contained in PR Notice 93-9, in this instance, are being used for 
formatting purposes only. It should be noted that PR Notice 93-9 
applies only to applicants seeking to register new active ingredients, 
and should not be confused with the call for safer alternatives for the 
control of rice water weevil that applies to both new active 
ingredients and new uses of active ingredients registered on other 
sites.
    The letters of interest should also indicate when an application 
could be submitted. If registrants cannot provide a precise schedule, 
they should give an approximation of when they believe their section 3 
application and tolerance requests will be submitted. EPA will treat 
information supplied by registrants as confidential, if the registrant 
so requests. Unit X of this notice, outlines procedures for submitting 
confidential business information.
    Respondents need not submit actual registration applications at 
this time. EPA intends to evaluate the letters/rationales received in 
response to this notice to determine which ones may qualify for special 
consideration as reduced risk pesticides. If the rationale provided 
demonstrates the opportunity for risk reduction, EPA will notify the 
registrant that the Agency will consider this factor in determining 
review priority for their registration application for the rice use. 
However, when registration packages are submitted, they must include 
all relevant data necessary for EPA to complete a risk assessment and 
make a regulatory decision.
    EPA is willing to consider other incentives that may apply in 
specific cases, for example, waiving tolerance fees for small 
businesses seeking registrations for biological pesticides. The Agency 
encourages registrants to suggest other reasonable incentives that may 
apply to their case that would stimulate their interest in coming 
forward sooner rather than later with registrations for the rice use.
    EPA recognizes the cost of developing additional data for an 
aquatic food use such as rice may be a potential barrier to registering 
reduced risk alternatives. The Agency encourages pesticide user groups, 
including grower organizations, to consider the option of providing 
assistance in developing the data required to support registration of 
alternatives to control rice water weevil. Assistance provided by user 
groups could range from participation in efficacy, crop residue, and 
phytotoxicity studies, to direct funding of environmental or human 
safety studies.
    EPA is also interested in data on the effectiveness of biological, 
cultural and integrated pest control strategies for rice water weevil. 
Material related to alternatives and incentives should be sent to the 
contact designated at the beginning of this notice.

VIII. Coordination with USDA

    EPA is working with USDA to improve existing procedures to ensure 
that all affected end users are notified of EPA's proposed pesticide 
actions and are provided with the opportunity to contribute information 
relevant to those actions in a timely manner. EPA is also working with 
USDA to provide information to researchers on pesticides which have 
triggered environmental or human health concerns, so that this 
information can be used in identifying needs for research and 
development of alternatives.

IX. Public Comments

    In the course of the Special Review of granular carbofuran, and in 
Special Reviews in general, EPA has relied on certain categories of 
data. Data used for Special Review decisions are derived from studies 
using controlled, scientific methods.
    For the benefits assessments these data include: comparative 
product performance (efficacy) data, particularly data on yield loss 
and market grade losses; quantitative usage data; data related to the 
distribution and life cycle of crop pests; and historic data on pest 
damage and levels of infestation. Comparative product performance data 
is generated from side-by-side trials of carbofuran and its 
alternatives. Performance tests compare the ability of products to 
control a specific pest and some also evaluate the effects on yield.
    Data considered in the granular carbofuran Special Review avian 
risk assessment include: laboratory toxicity data; toxicity and 
relative risk of alternative pest control measures; field studies; 
monitoring programs; and poisoning incidents associated with direct and 
secondary exposure to carbofuran. Field studies and monitoring both 
require systematic observation by technicians trained to recognize 
abnormal bird behavior and other evidence of exposure. In order to be 
scientifically valid, field studies should be conducted according to 
established protocols for survey methods, searching techniques and 
timing, and documentation of environmental conditions and application 
practices. The incident data used by EPA in the granular carbofuran 
Special Review generally involve laboratory analysis of bird carcasses 
to determine cause of death.
    Commentors are advised that data related to the categories listed 
above will be most useful to the Agency in reviewing the proposed 
regulatory decision on granular carbofuran. Letters of a testimonial 
nature without supporting, scientifically derived data are of limited 
utility.
    The following information would also be useful to the Agency:
    1. Letters of intent or interest in registering new or existing 
chemicals for control of rice water weevil, as described in unit VII of 
this notice.
    2. Data on additional measures that could be adopted to reduce 
avian risk.
    3. Information from growers or organizations with knowledge of 
effective, non-chemical or IPM strategies for control of rice water 
weevil.
    4. Data on the long-term impacts of population growth and 
geographic distribution of rice water weevil.
    5. Data on the effectiveness of clean farming in controlling rice 
water weevil, and the schedule of vegetation removal in relation to 
bird use of rice fields.
    6. State agricultural and wildlife agencies are encouraged to 
comment on methods to further reduce the use of granular carbofuran in 
rice growing areas through prescriptive use or other measures, and on 
how to monitor enforcement of label restrictions more effectively.

X. Public Record

    EPA has established a public record (OPP-30000/48) for the granular 
carbofuran Special Review and related actions. The public record 
includes:
    1. This Notice.
    2. Materials submitted by the FMC Corporation and others in support 
of their request to modify the terms and conditions of the granular 
carbofuran registrations.
    3. EPA's ``Analysis and Recommendation RE: FMC's Proposal to 
Reinstate the Use of Granular Carbofuran on Corn, Sorghum, and Rice.''
    4. EPA's Federal Register notice announcing receipt of FMC's 
request to amend their granular carbofuran registrations. July 19, 1991 
(56 FR 33286).
    5. EPA's Federal Register notice concluding the Special Review of 
granular carbofuran. December 11, 1991 (56 FR 64621).
    6. Other correspondence and documents related to the Special Review 
of granular carbofuran.
    7. A current index of materials in the public docket.
    Written comments received in response to this notice will be placed 
in the public docket. If substantive comments are received during the 
90-day comment period, EPA will issue a second notice responding to the 
comments.
    Information submitted in any comment concerning this notice may be 
claimed confidential by marking any part or all of that information as 
``Confidential Business Information'' (CBI). Information so marked 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 by EPA without prior notice to the 
submitter.
    The docket and index will be available for inspection and copying 
from 8:00 a.m. to 4:30 p.m., Monday through Friday, except legal 
holidays, at the address given earlier in this notice.

    Dated: March 28, 1994.

Douglas D. Campt,
Director, Office of Pesticide Programs.

[FR Doc. 94-8733 Filed 4-12-94; 8:45 am]
BILLING CODE 6560-50-F