Environmental Protection Agency (EPA).
Final Determination and Termination of Special Review.
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.Start Further Info
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@example.com.End Further Info End Preamble Start Supplemental 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 Start Printed Page 58469indicate 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 Start Printed Page 58470prior 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 Start Printed Page 58471premature 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:Start Printed Page 58472
|Distance from treated field (m)||Mean conc. 7 day (μg/m3)||Mean conc. 15 day (μg/m3)|
|125 Edge of buffer zone1||92||56|
|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.Start List of Subjects
List of Subjects
- Environmental protection
Dated: November 8, 2001.
Assistant Administrator for Prevention, Pesticides and Toxic Substances
[FR Doc. 01-28972 Filed 11-20-01; 8:45 am]
BILLING CODE 6560-50-S