[Federal Register Volume 66, Number 225 (Wednesday, November 21, 2001)]
[Notices]
[Pages 58468-58472]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-28972]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-30000/51B; FRL-6794-4]


1,3-Dichloropropene (Telone); Notice of Final Determination for 
Termination of the Telone Special Review

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final Determination and Termination of Special Review.

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SUMMARY: In a Federal Register Notice of January 12, 2000 (65 FR 1869) 
(hereafter called the ``Telone PD2'' or ``PD2''), EPA proposed to 
terminate the Telone Special Review based on the determination that the 
benefits of use outweigh the risks. The Agency solicited public 
comments for a 60-day period. Following its review of submitted 
comments, the Agency believes that the benefits of Telone use continue 
to outweigh the risks. Thus, with this notice, EPA is announcing that 
it has terminated the Telone Special Review.

FOR FURTHER INFORMATION CONTACT: Wilhelmena Livingston, Special Review 
and Reregistration Division (7508C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., 
Washington, DC 20460. Telephone (703) 308-8025. E-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are a pesticide 
registrant with registered products which contain 1,3-Dichloropropene 
(1,3-D or Telone) as an active ingredient, if you are an agricultural 
producer or worker using products containing 1,3-D as an active 
ingredient, or if you live in and around agricultural areas where 1,3-D 
is used.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. By mail. You may request copies of this document by writing to: 
Public Information and Records Integrity Branch, Information Resources 
and Services Division (7202C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., 
Washington, DC 20460 or by calling (703) 305-5805 between 8:30 a.m. and 
4 p.m., Monday through Friday, excluding legal holidays. Be sure to 
include the docket control number [OPP-30000/51B] in your request.
    2. In person. The Agency has established an official record for 
this action under docket control number [OPP-30000/51B]. The official 
record consists of all documents in the Telone Special Review docket, 
Federal Register notices pertaining to actions under the Special Review 
regulations, including supporting documents, any public comments 
received during an applicable comment period, and other information 
related to this action, including any information claimed as 
confidential business information (CBI). The official record includes 
documents that are physically located in the docket, as well as 
documents that are referred to in those documents. The public version 
of the official record does not include any information claimed as CBI. 
The public version of this record, including printed, paper versions of 
any electronic comments, is available for inspection in the Public 
Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 
#2, 1921 Jefferson Davis Highway, Arlington, VA, from 8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays. The PIRIB 
telephone number is (703) 305-5805.
    3. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/.

II. Response to Comments Submitted on EPA's Proposed Determination 
to Terminate Special Review

A. Public Comments and Agency Responses to the Toxicological Concerns 
Contained in the Proposal to Terminate the Special Review

    1. Comment. Dow Agrosciences commented that EPA omitted the 
findings of several studies critical to deriving any conclusion 
regarding the potential genotoxicity of 1,3-D in the PD2 discussion. 
According to Dow AgroSciences, these studies clearly

[[Page 58469]]

indicate a lack of genotoxic potential of 1,3-D.
    Response. The studies in question were not available at the time 
the PD2 was prepared and published in the Federal Register. They are:
     Inhalation Dominant Lethal Assay in Rats (MRID No. 
44302801)
     P-Post Labeling Assay in Rats (MRID No. 44446302)
     Transgenic Mutagenesis Assay (MRID No. 44470501)
     In vitro DNA Binding Assay (MRID No. 44446301)
    The studies were either unacceptable or they did not provide 
evidence of a non-genotoxic mode of action. Findings from these studies 
can be found in HED document No. 012317 (Dominant Lethal Assay) and HED 
document No. 013566 (studies 2-4).
    2. Comment. Dow Agrosciences commented that, contrary to EPA's 
discussion in Unit III. C of the PD2, the formation of 1,3-D epoxide is 
not a significant or relevant metabolic pathway in the mouse at non-
acute lethal doses and via the conceivably anticipated routes of 
exposure (inhalation or ingestion) that are expected to occur during 
product use conditions. Dow Agrosciences questioned the relevance of 
studies used to come to these conclusions because doses used in the 
study (Schneider et al.) either were equal to or exceeded the 
LD50 for telone and the route of exposure represented the 
``less relevant route.''
    Response. The study being questioned by Dow Agrosciences did indeed 
use doses which exceeded the LD50 of 300 milligram/kilogram 
(mg/kg). However, the purpose of the study and the way HED scientists 
used the data was to identify the hazard (i.e., the capacity of 1,3-D 
to produce mutagenic epoxides both in vitro and in vivo), rather than 
determine dose levels. Hazard identification, which identifies the 
components of a toxic response, is a crucial step in the risk 
assessment process. Qualitatively, therefore, the study of Schneider et 
al has provided information on the hazard potential resulting from 
epoxide formation.
    3. Comment. Dow Agrosciences submitted the results of a series of 
mammalian and environmental toxicology studies which evaluated the 
properties of the acid and alcohol metabolites of 1,3-D. Based on this 
metabolite-specific data base, Dow AgroSciences requested that the acid 
and alcohol metabolites no longer be judged as having equal toxicity as 
1,3-D and that, instead, assessments of exposure and risk should be 
made for the metabolites separate from the parent.
    Response. The Agency is concluding this Special Review with the 
assumption that the acid and alcohol metabolites have equal toxicity as 
the parent. Even with this conservative assumption, the Agency has 
concluded that Telone benefits exceeds the risk. However, for future 
registration activities, the Agency will review the submitted data to 
determine whether it is appropriate to conduct a separate exposure and 
risk assessment for the 1,3-D acid and alcohol metabolites.
    4. Comment. A number of commenters questioned EPA's reliance on 
research by the National Toxicology Program (NTP), stating that the 
NTP's Technical Report Review Subcommittee includes an employee of the 
parent company for the Telone pesticide registrant. Another commenter 
(Friends of the Earth) also questioned the validity of the studies 
conducted by the registrant, which were cited by EPA in its proposed 
decision. This commenter felt that the Agency should conduct its own 
studies to verify the findings of registrant sponsored studies.
    Response. The Agency routinely requires registrants to conduct 
studies that help identify potential human health or ecological risks. 
These studies generally form the majority of studies available to the 
Agency when assessing the risks associated with pesticide use. Studies 
are often conducted by independent laboratories and are subject to the 
Agency's Good Laboratory Practice guidelines found in 40 CFR part 160. 
The Agency, not the registrants, analyzes the results of each study to 
determine the data's implications for regulatory purposes. Failure to 
comply with good laboratory practices may result in EPA's refusal to 
consider the data reliable for the purpose of supporting regulation of 
a pesticide. In addition, tampering with study findings can result in 
both criminal and civil penalties.
    5. Comment. Friends of the Earth felt that EPA underestimated the 
ability of Telone to irritate the skin and cause systemic toxicity, 
citing a 1986 study by Cornell stating that the chemical is a moderate 
skin irritant, rather than a slight irritant as stated by the EPA. The 
Occupational Safety and Health Administration's permissible exposure 
limit for Telone also includes a skin notation to help protect against 
telone's ability to cause systemic toxicity when absorbed through the 
skin.
    Response. Telone is classified as a slight skin irritant (Toxicity 
Category III; slight to well-defined erythema and very slight to slight 
edema observed at 72 hours following exposure), based upon results of 
the acute primary skin irritation toxicity study, which the Agency has 
reviewed and determined to be acceptable. Any other study which may be 
relevant to EPA human health assessment of Telone should be submitted 
to EPA, so the Agency can determine its validity under the current 
testing guidelines.
    Telone is assigned Toxicity Category II based upon the toxicities 
identified in three acute mammalian studies (acute oral, acute dermal, 
and primary eye irritation toxicity studies). The category for labeling 
purposes is assigned on the basis of the highest hazard shown by 
specific indicators in the battery of acute toxicity studies. Hence, 
the product labeling for telone reflects adequate precautionary 
statements, use precautions, environmental hazards, handling and 
protective equipment requirements, maximum application rates, and other 
exposure mitigation, measures for pesticides meeting the Toxicity 
Category II criteria.
    6. Comment. In questioning the Agency's conclusions regarding 
mutagenicity in the PD2, the registrant also referred to the Agency's 
reference to an ``in vivo formation of DNA lesions in various organs, 
including the stomach, colon, liver, kidney, bladder, brain, and bone 
marrow.'' The registrant indicated a belief that these results were 
based on flawed data, making reference to these lesions inappropriate.
    Response. This finding appears to have come from the study of Ghia 
et al., 1993. In this assay, significant DNA fragmentation was observed 
in the liver (p<0.01 to <0.002), gastric mucosa (p<0.05), and the 
kidney (p<0.01) of rats 3 hours after the oral gavage administrations 
of 62.5, 125 or 250 mg/kg. The effect in the liver was dose-related. 
Based on the Agency's revisit of the study, it also appears that 
findings for the lungs, brain, and bone marrow were erroneously 
presented as positive for DNA single strand breaks and the rat bladder 
was not tested. These errors will be corrected in future risk 
assessments. However, it should be emphasized that mutagenicity results 
will not impact the Agency's Special Review determination.

B. Public Comments and Agency Responses to Telone Incident Data

    Comment. Dow AgroSciences noted that a reference in the PD2 to a 
reported case of a farmer contracting leukemia as a result of being 
accidentally sprayed in the face with Telone as a result of a leaky 
hose was inaccurate. Dow AgroSciences provided public court records 
from a related case in California, arguing that the farmer had leukemia

[[Page 58470]]

prior to the Telone exposure and, therefore there was no association 
between the leukemia and Telone exposure.
    Response. The Agency agrees that when a disease precedes pesticide 
exposure, this does not support evidence of risk. However, based solely 
on the legal brief submitted to the Agency in support of this assertion 
of diagnosis prior to Telone exposure, it is not possible for the 
Agency to confirm that this is what occurred. Therefore, this 
information does not provide EPA with any basis for evaluating the 
relationship between the Telone exposure and the farmer's leukemia and 
the usefulness of this incident in evaluating the health risks 
associated with Telone.

C. Public Comments and Agency Responses to the Groundwater 
Contamination Potential of Telone

    1. Comment. Dow AgroSciences commented that it was inappropriate to 
base potential dietary exposure to Telone in the PD2 on residue values 
developed using ``on-site'' wells from the Florida prospective 
groundwater study because of the requirement of a 100-foot setback from 
any treated field to the nearest potable drinking water well that was 
added to Telone product labels in 1999.
    Response. EPA agrees that the ``on-site'' wells (wells on fields 
treated with Telone) do not provide the most accurate estimates of 
Telone concentrations in drinking water for use in calculating dietary 
exposure. However, these were among the most reliable data available to 
the Agency at the time of the PD2. The tap water monitoring program, 
which is currently underway, will allow the Agency to more accurately 
calculate dietary risk from groundwater sources.
    2. Comment. A number of commenters questioned why Telone use was 
not banned in Florida, when it was specifically banned in other states. 
The prevalence of karst geology and shallow groundwater in Florida make 
Florida more vulnerable to potential groundwater contamination from 
Telone.
    Response. Telone use is banned in areas of karst geology. The label 
language currently reads:
    Do not apply in areas overlying karst geology. In North Dakota, 
South Dakota, Wisconsin, Minnesota, New York, Maine, New Hampshire, 
Vermont, Massachusetts, Utah, and Montana: where groundwater aquifers 
exist at a depth of 50-feet or less from the surface, do not apply this 
product where soils are Hydrologic Group A.
    The prohibition on use in areas overlying karst geology applies to 
all states. The prohibition on use where groundwater aquifers are less 
than 50-feet from the surface and where soils are Hydrologic Group A, 
on the other hand, applies only to those states specifically listed 
(based on colder climate conditions identified as promoting the 
potential for groundwater contamination). The Agency has notified the 
registrant of the potential misreading of the label language and has 
encouraged the registrant to place these prohibitions on separate lines 
to avoid confusion, and to clarify the prohibitions in their product 
stewardship manual.
    Telone use is prohibited in Florida in any areas of karst geology. 
The Telone Reregistration Eligibility Decision (RED) also includes a 
tap water monitoring requirement for any future Telone use (should such 
use occur in areas of non-karst geology) and built-in future 
restrictions if groundwater levels exceed the Telone drinking water 
level of comparison (DWLOC).
    3. Comment. Friends of the Earth commented that the Agency should 
require a minimum of a 300-foot buffer from water wells, rather than 
the current 100-foot buffer.
    Response. The data currently available do not allow the Agency to 
quantify the degree of protection afforded by any specific buffer 
distance. The Agency recognizes that a number of factors can influence 
the potential for groundwater contamination, including soil 
temperature, soil type, depth of application, etc. As a result, the tap 
water monitoring program is designed to help identify any further 
vulnerable areas. This could result in further restrictions on the set 
back from drinking water wells in Telone's use areas.
    4. Comment. The Environmental Center expressed concerns about 
Telone's potential to contaminate groundwater in Hawaii because the 
State relies on groundwater as a source of drinking water.
    Response. The potential for groundwater contamination is well 
established for Telone and its degradates. Dow AgroSciences is 
currently conducting a 5 Region monitoring program to determine if 
Telone concentrations in groundwater used as a source of drinking water 
may reach levels of concern, despite extensive mitigation measures 
already put in place. The state of Hawaii is not included in this 
program, because it was determined that Telone's use in Hawaiian 
agriculture is not substantial. Therefore, the potential for widespread 
contamination or concentrations of concern would not be anticipated. If 
problem areas are identified from the monitoring program, the results 
will be extrapolated to other Telone use areas, including Hawaii, while 
considering the local conditions that may impact environmental 
occurrence and levels. If Telone use expands to new areas and/or new 
use patterns as a result of any future phase out of methyl bromide or 
other nematicides prior to analysis of the monitoring program's 
results, the potential impact to areas not included in the current 5 
region program, based on best available information, will be a primary 
criterion in requiring monitoring in these areas, including Hawaii.
    5. Comment. The Shoshone-Bannock Tribes stated that Dow 
AgroSciences should also sample irrigation wells, not just drinking 
water wells as part of their tap water monitoring program.
    Response. Sampling of drinking water wells provides the most 
accurate information on dietary risk from drinking water. Data from 
irrigation wells would only be used in a situation where more 
representative data is not readily available, as it provides a more 
conservative estimate of dietary exposure from drinking water, since 
irrigation wells are not generally used as a source of drinking water.
    6. Comment. The Shoshone-Bannock Tribes noted that Telone 
degradates have been found in water and that they are concerned about 
the presence of the degradates in water, not just the presence of the 
Telone parent.
    Response. The Agency did not have data on the toxicity of the 
Telone degradates when it conducted its risk assessments for the PD2. 
The Agency therefore made the conservative assumption that the 
degradates would be as toxic as the parent compound. The registrant has 
submitted new data to better characterize the toxicity of the 
degradates, and has asked that the Agency no longer make the assumption 
that the degradates are as toxic as the 1,3-D parent. As noted above in 
response to comment 3, EPA will review these data and will determine 
whether it is appropriate to conduct a separate risk assessment for 
degradates. However, the Agency believes that these data are unlikely 
to change the risk-benefit determination for Telone.

D. Public Comments and Agency Responses to Agency Determination That 
Benefits of Telone Use Outweigh Benefits

    1. Comment. The Miami-Dade county Department of Environmental 
Resource Management commented that it was

[[Page 58471]]

premature to remove Telone from Special Review. The Department noted 
that there is a pending Special Local Need (SLN) registration for 
Telone use on turf and that EPA had issued a Notice of Intent to 
Disapprove this SLN. The Department felt that the Special Review 
determination should be delayed until groundwater monitoring in Miami-
Dade county could be completed and air quality concerns expressed by 
EPA for this SLN are addressed and demonstrate that Telone does not 
pose an undue risk to human health and the environment.
    Response. EPA is reviewing additional data submitted in response to 
its Notice of Intent to Disapprove the SLN registration for Telone use 
on turf. The SLN is being held in abeyance until the review of data is 
completed. If these concerns are not adequately addressed, the Agency 
will disapprove the SLN registration. It should be noted, however, that 
this decision is independent of the Special Review action. The Agency's 
proposal to terminate the Telone Special Review is based on a risk-
benefit balancing for current Telone uses. Before any new use can be 
registered, the registrant must demonstrate that the use will not cause 
unreasonable adverse effects on the environment.
    2. Comment. The Shoshone-Bannock Tribes commented that EPA should 
wait for the results of the ongoing tap water monitoring before 
terminating the Telone Special Review.
    Response. The Agency believes it is appropriate to terminate the 
Telone Special Review prior to completion of the tap water monitoring 
study, since additional restrictions will be automatically incorporated 
into the Telone registration if the tap water monitoring demonstrates 
remaining groundwater contamination concerns. Since any additional 
necessary restrictions will be automatically incorporated, it is not 
necessary to keep the Telone Special Review open. The Special Review 
process provides a mechanism for the Agency to impose limitations on a 
pesticide which is already on the market. In the case of Telone, the 
registrant must, as an outcome of the Agency's Telone Reregistration 
Eligibility Decision, impose additional mitigation measures if the tap 
water monitoring indicates such measures are necessary.
    Based on available data and conservative assumptions, the Agency 
has determined that the benefits of telone use outweigh the risks of 
such use. If the tap water monitoring study demonstrates that certain 
areas remain vulnerable to groundwater contamination despite existing 
mitigation measures, the registrants have already committed to imposing 
additional use restrictions to prevent the potential for such 
groundwater contamination.
    3. Comment. The Florida Consumer Action Network, the Farmworkers 
Association of Florida, Inc., and Friends of the Earth commented that 
there is insufficient evidence that the benefits of Telone use outweigh 
the risks. Friends of the Earth noted that there were other methyl 
bromide alternatives available. The Farmworker's Association of Florida 
also expressed concern about the lack of information on the synergistic 
effects of Telone when used in combination with other weed control 
agents.
    Response. As detailed in the Telone PD2, the Agency believes that 
the benefits of Telone use outweigh the risks and that the Special 
Review should therefore be terminated. The benefits analysis included 
an assessment of all Telone nematicide alternatives, not just methyl 
bromide. EPA agrees that there is a lack of information on the 
synergistic effects of Telone when used in combination with other weed 
control agents. The Agency's approach to regulating pesticides is 
generally to review products by active ingredient. Thus, EPA considers 
the risks posed by Telone separately from the risks posed by the active 
ingredients in the other weed control agents. Each active ingredient 
must demonstrate acceptable risk individually before it can be 
registered or reregistered. In the absence of data that would show that 
synergistic risks exist, the Agency is unable to characterize the 
effects of combining pesticidal active ingredients and does not believe 
that it is necessary to do so for Telone based on currently available 
data.
    4. Comment. The Metam Sodium Task Force commented that EPA had 
understated the benefits and overstated the risks of Metam sodium, a 
Telone alternative, in the PD2.
    Response. The Agency is currently developing the Metam Sodium 
Reregistration Eligibility Decision, which will provide a more accurate 
assessment of Metam sodium risks. At the time of publication of the 
Telone PD2, the Agency could only develop a very rough risk and 
benefits assessment for Metam sodium. Although the Agency described the 
risks of the main Telone alternatives, this was, of necessity, a 
qualitative rather than quantitative comparison where the database 
remained incomplete and no risk assessment for the alternative had been 
conducted due to data deficiencies.

E. Public Comments and Agency Responses on Worker Exposures to Telone

    1. Comment. The Farmworker Association of Florida, Inc. and Friends 
of the Earth expressed concern that EPA's worker risk assessment 
assumed farmworkers comply with Telone labels and use the required 
protective equipment. These groups noted that farmworkers often do not 
follow personal protective equipment (PPE) requirements.
    Response. When PPE requirements are added to pesticide labels, the 
Agency considers whether such requirements are realistic. The Agency is 
aware that farmworkers may not always follow PPE requirements. However, 
Telone is a Restricted Use Pesticide which must be applied by certified 
applicators, who have received special training, or by workers who are 
under their direct supervision. This requirement increases the 
likelihood that workers handling Telone will comply with PPE.
    2. Comment. The Environmental Center commented that in addition to 
label restrictions, some type of applicator training should be 
mandatory.
    Response. Telone is a restricted use pesticide. This means that 
Telone can only be applied by certified applicators, who must complete 
a required course of study, or by workers under the direct supervision 
of a certified applicator. In addition, Dow AgroSciences has compiled a 
detailed product stewardship manual for Telone users, which provides 
more specific guidance to users on how to comply with the label 
restrictions and to ensure the safe use of Telone.

F. Public Comments and Agency Response on Buffer Zones to Address Drift 
to Bystanders

    1. Comment. Dow AgroSciences noted a discrepancy between the 
information summarized in Table 5 of the PD2 and Table 8 in the 1998 
Telone Reregistration Eligibility document on the results of off-site 
air monitoring.
    Response. The Agency agrees that Table 5 of the PD2 contained some 
errors. The corrected table is as follows:

[[Page 58472]]



 Table 5.--Offsite Air Monitoring Data Using Average Concentrations From
                     Three Study Sites (AZ, NC, WA)
------------------------------------------------------------------------
                                   Mean conc. 7 day    Mean conc. 15 day
 Distance from treated field (m)   (g/m\3\)   (g/m\3\)
------------------------------------------------------------------------
1600 (AZ)                         3                   2
------------------------------------------------------------------------
1,200 (AZ)                        6                   4
------------------------------------------------------------------------
800                               11                  7
------------------------------------------------------------------------
500                               19                  10
------------------------------------------------------------------------
125 Edge of buffer zone\1\        92                  56
------------------------------------------------------------------------
25                                196                 63
------------------------------------------------------------------------
5                                 185                 67
------------------------------------------------------------------------
onsite                            181                 171
------------------------------------------------------------------------
\1\Edge of buffer zone - EPA uses this distance to approximate risks at
  300-feet buffer

    The errors in Table 5 of the PD2 did not affect the Agency's risk-
benefit determination or conclusions about potential bystander exposure 
to Telone.
    2. Comment. Friends of the Earth expressed concerns about pesticide 
drift from telone use and asked that EPA prohibit Telone fumigation 
within 72 hours of activities in and around schools, nursing homes, and 
similar structures. Friends of the Earth also requested that ``occupied 
structures'' for the purposes of the 300-foot buffer be better defined.
    Response. The Agency believes that the 300-foot buffer zone around 
occupied structures provides protection to those in and around schools, 
nursing homes, and other structures from potential 1,3-D drift. This 
buffer area provides the same type of protection suggested by the 
Friends of the Earth's 72-hour prohibition on use.
    The term ``occupied structure'' is broadly defined on the label to 
be a structure ``such as a school, hospital, business, or residence.'' 
The label further specifies that ``no person shall be present at this 
structure at any time during the 7 consecutive day period following 
application'' to ensure that Telone cannot be used around structures, 
without the 300-foot buffer zone, even if such structures are 
unoccupied at the time of actual Telone application, if individuals 
would be returning to the structure earlier than 7 days (or 168 hours) 
following Telone use. The Agency does not have any information 
suggesting that users of Telone have experienced confusion from the 
current label language that would require clarification of the term 
``occupied structure.''

G. Request for Extension of Comment Period

    Comment. The Florida Consumer Action Network and Farmworker 
Association of Florida, Inc. requested an extension of the Telone PD2 
comment period, because they felt that the farmworker advocacy 
community had not been adequately notified of EPA's proposed 
termination of the Special Review, since farmworkers had not been 
included in the introduction to the PD2 among the list of those 
affected by the proposal.
    Response. A number of national and regional farmworker advocacy 
groups routinely receive notice of the Agency's proposed actions. The 
Agency also received a number of comments from farmworker and other 
advocacy groups in response to the PD2. Although the Agency strives to 
notify regional groups that may be interested in a given action, it is 
not possible for the Agency to identify all such groups for every 
decision. Since these groups requesting an extension did have time to 
file their comments, and did not identify any other groups who did not 
have enough time, EPA is not extending the comment period for this 
action.

H. Telone CIS-Isomer vs. Trans-Isomer

    Comment. The Shoshone-Bannock Tribes urged that EPA should only 
allow the Telone registrant to market the CIS-isomer formulation of 
Telone, as in Europe, and not the TRANS-isomer, because only the CIS-
isomer of Telone is effective as a nematicide.
    Response. The Agency does not have any information that the TRANS-
Isomer is not effective as a nematicide. Further, Telone has already 
met the standard for registration in the context of Reregistration and 
Special Review as a mixture of the CIS-Isomer and TRANS-Isomer. 
Therefore, the Agency does not see any reason to require the registrant 
to reformulate Telone as a single-Isomer formulation at this time.

III. Ecological Effects

    Comment. Friends of the Earth expressed the opinion that EPA should 
pay more attention to the ecological effects of Telone use, due to the 
abundance of wildlife in Florida.
    Response. The scope of the Special Review is limited to human 
health carcinogenicity concerns. However, the Telone RED of 1998 
evaluated the ecological risks posed by Telone use. Further through the 
RED process, under the FIFRA Section 3(c)(2)(b) authority, the Agency 
required several ecological effects studies which will be evaluated.

IV. The EPA's Decision Regarding Special Review

    This notice concludes EPA's administrative Special Review of the 
risks and benefits of Telone, which was initiated in a Federal Register 
notice of October 8, 1986 (51 FR 36160). In the January 12, 2000 
Federal Register (65 FR 1869), EPA announced its intent to terminate 
the Telone Special Review. As stated in that document, based on its 
risk and benefits assessment, EPA has concluded that the benefits 
provided from the continued existing uses of Telone outweigh the risks. 
EPA's review of comments received in response to the January 12, 2000 
proposal to terminate the Telone Special Review, have not resulted in a 
change in the Agency's risk-benefit determination. Accordingly, for the 
reasons set forth in the January 12, 2000 notice (65 FR 1869) (FRL-
6380-6). EPA is announcing that it has terminated the Telone Special 
Review.

List of Subjects

    Environmental protection, Pesticides.

    Dated: November 8, 2001.
Stephen Johnson,
Assistant Administrator for Prevention, Pesticides and Toxic Substances
[FR Doc. 01-28972 Filed 11-20-01; 8:45 am]
BILLING CODE 6560-50-S