Thiram; Pesticide Tolerances
Federal Register, Volume 79 Issue 29 (Wednesday, February 12, 2014)
Federal Register Volume 79, Number 29 (Wednesday, February 12, 2014)
Rules and Regulations
Pages 8295-8301
From the Federal Register Online via the Government Printing Office www.gpo.gov
FR Doc No: 2014-03074
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
EPA-HQ-OPP-2012-0925; FRL-9904-22
Thiram; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of thiram in or on strawberry. Taminco, Inc. requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective February 12, 2014. Objections and requests for hearings must be received on or before April 14, 2014, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2012-0925, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington,
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DC 20460-0001; telephone number: (703) 305-7090; email address: RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
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General Information
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Does this action apply to me?
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
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How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP test guidelines referenced in this document electronically, please go to http://www.epa.gov/ocspp and select ``Test Methods and Guidelines.''
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How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2012-0925 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before April 14, 2014. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2012-0925, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.
Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.htm.
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.
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Summary of Petitioned-for Tolerance
In the Federal Register of January 16, 2013 (78, FR 3379) (FRL-
9375-4), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 2F8106) by Taminco, Inc., 7540 Windsor Drive, Suite 411, Allentown, PA 18195. The petition requested that 40 CFR 180.132 be amended by increasing the level of the tolerance for residues of the fungicide thiram, in or on strawberry to 20 parts per million (ppm). This request was made to support a change in the preharvest interval (PHI) from 3 days to 1 day for strawberry on the label for Spotrete-F (EPA Reg. No. 45728-26). That document referenced a summary of the petition prepared by Taminco, Inc., the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.
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Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.'' This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ``ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .''
Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for thiram including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with thiram follows.
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Toxicological Profile
EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.
Thiram is a dimethyl dithiocarbamate fungicide. Thiram has been shown to cause neurotoxicity following acute and subchronic exposures. In the acute and subchronic neurotoxicity studies submitted, neurotoxicity is characterized as lethargy, reduced and/or tail pinch response, changes in the functional-observation battery (FOB) parameters, increased hyperactivity, changes in motor activity, and increased occurrences of rearing events. No treatment-related changes were observed in brain weights or in the histopathology of the nervous system. In a non-guideline study published in the open literature, chronic feeding of thiram to rats caused neurotoxicity, with onset of ataxia in some animals 5-19 months after beginning of treatment. However, no evidence of neurotoxicity was seen following chronic exposures in mice or rats in guideline studies submitted to the Agency. In addition, no adverse effects on the developing fetal nervous system were seen in a DNT study. The chronic toxicity profile for thiram indicates that the liver, blood, and urinary system are the target organs for this chemical in mice, rats, and dogs. There is no evidence for increased
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susceptibility following in utero exposures to rats or rabbits and following pre- and post-natal exposures to rats for two generations. There is evidence of quantitative susceptibility in the developmental neurotoxicity (DNT) study. However, there is low concern for the increased susceptibility seen in the DNT study since the dose response is well defined with a clear NOAEL and this endpoint is used for assessing the acute dietary risk for the most sensitive population. Thiram is classified as ``not likely to be carcinogenic to humans'' based on lack of evidence for carcinogenicity in mice or rats. There are no mutagenic/genotoxic concerns with thiram. The available toxicological database for thiram suggests that this chemical has a low to moderate acute-toxicity profile.
Specific information on the studies received and the nature of the adverse effects caused by thiram as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document Thiram. Update to the Aggregate Risk Assessment to Support the Requested PHI Reduction and Increased Tolerance Request on Strawberry at page 9 in docket ID number EPA-HQ-
OPP-2012-0925.
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Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level--generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)--and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
Table 1--Summary of Toxicological Doses and Endpoints for Thiram for Use in Human Health Risk Assessment
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Study and
Exposure/ Scenario PoD Uncertainty/FQPA RfD, PAD, LOC for toxicological
SFs risk assessment effects
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Acute Dietary (General BMDL10 = 64.94 mg/ UFA = 10x......... Acute RfD = 0.6494 Acute
Population). kg. UFH = 10x......... mg/kg/day. Neurotoxicity
FQPA SF = 1x...... aPAD = 0.6494 mg/ Study--Rat. MRID
kg/day. 42912401.
LOAEL = 150 mg/kg/
day based on FOB
effects
(lethargy, lower
temperature,
reduced startle
response, no tail-
pinch response),
reduced motor
activity, and
reduced brain
weights.
Acute Dietary (Females 13-49 NOAEL = 1.4 mg/kg. UFA = 10x......... Acute RfD = 0.014 Dev. Neurotoxicity
years old). UFH = 10x......... mg/kg/day. Study--Rat. MRID
FQPA SF = 1x...... aPAD = 0.014 mg/kg/ 46455201.
day. LOAEL = 3.7 mg/kg/
day based on
increases in
motor activity
seen in female
offspring on PND
17.
Chronic Dietary (All NOAEL = 1.5 mg/kg. UFA = 10x......... Chronic RfD = Co-critical: (1)
populations). UFH = 10x......... 0.015 mg/kg/day. Combined Chronic
FQPA SF = 1x...... cPAD = 0.015 mg/kg/ Toxicity/
day. Carcinogenicity
Study--Rat and
(2) Chronic Oral
Toxicity-Dog.
LOAEL = 7.3 mg/kg/
day based on
changes in
hematology,
clinical
chemistry,
incidences of
bile duct
hyperplasia, and
reduction in mean
body-weight gain
from the chronic
toxicity/
carcinogenicity
rat study in
conjunction with
elevated
cholesterol
levels and
increased liver
weights reported
in the Chronic
Oral Toxicity
Study in Dogs at
a LOAEL = 7.23 mg/
kg/day.
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Short- and Intermediate-Term No incidental oral residential exposure.
Incidental Oral.
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Short-Term Dermal (1-30 days)... NOAEL = 1.4 mg/kg/ UFA = 10x......... Residential LOC Dev. Neurotoxicity
day. UFH = 10x......... for MOE = 100. Study--Rat MRID
FQPA SF = 1x Occupational LOC 46455201.
(Dermal- for MOE = 100. LOAEL = 3.7 mg/kg/
absorption factor day based on
= 1%). increases in
motor activity
seen in female
offspring on PND
17.
Intermediate-Term Dermal (1 to 6 NOAEL = 1.4 mg/kg/ UFA = 10x......... Residential LOC Dev. Neurotoxicity
months). day. UFH = 10x......... for MOE = 100. Study--Rat MRID
FQPA SF = 1x Occupational LOC 46455201.
(Dermal- for MOE = 100. LOAEL = 3.7 mg/kg/
absorption factor day based on
= 1%). increases in
motor activity
seen in female
offspring on PND
17.
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Short- and Intermediate-Term Current assessment does not warrant an inhalation assessment.
Inhalation.
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Cancer (oral, dermal, ``Not Likely to be Carcinogenic to Humans''.
inhalation).
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Point of Departure (PoD) = A data point or an estimated point that is derived from observed dose-response data
and used to mark the beginning of extrapolation to determine risk associated with lower environmentally
relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect
level. UF = uncertainty factor. UFA = extrapolation from animal to human (intraspecies). UFH = potential
variation in sensitivity among members of the human population (interspecies). FQPA SF = Food Quality
Protection Act Safety Factor. PAD = population-adjusted dose (a = acute, c = chronic). RfD = reference dose.
MOE = margin of exposure. LOC = level of concern.
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Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary exposure to thiram, EPA considered exposure under the petitioned-for tolerances as well as all existing thiram tolerances in 40 CFR 180.132. EPA assessed dietary exposures from thiram in food as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure.
A refined probabilistic acute dietary exposure assessment was performed using maximum percent crop treated (PCT) values, tolerance, the highest residue found during field-trials, distribution of field trial residues, Federal Drug Administration (FDA) monitoring data for apples, and empirical processing factors. Dietary risk estimates were determined considering exposures from food and drinking water using estimated drinking water concentrations (EDWCs) for surface water sources.
ii. Chronic exposure. A refined chronic dietary-exposure assessment was performed using tolerance level residues and average estimated PCT.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has classified thiram as ``Not Likely to be Carcinogenic to Humans,'' therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.
iv. Anticipated residue and PCT information. Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must require pursuant to FFDCA section 408(f)(1) that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such data call-ins as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submitted no later than 5 years from the date of issuance of these tolerances.
Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if:
Condition a: The data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain the pesticide residue.
Condition b: The exposure estimate does not underestimate exposure for any significant subpopulation group.
Condition c: Data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area.
In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by FFDCA section 408(b)(2)(F), EPA may require registrants to submit data on PCT.
The Agency estimated the PCT in the acute dietary risk assessment for existing uses as follows apples: 10%; peaches: 2.5%; and strawberry: 30%. The Agency estimated the PCT in the chronic dietary risk assessments for existing uses as follows apples: 5%; peaches: 1.0%; and strawberry: 20%.
In most cases, EPA uses available data from United States Department of Agriculture/National Agricultural Statistics Service (USDA/NASS), proprietary market surveys, and the National Pesticide Use Database for the chemical/crop combination for the most recent 6-7 years. EPA uses an average PCT for chronic dietary risk analysis. The average PCT figure for each existing use is derived by combining available public and private market survey data for that use, averaging across all observations, and rounding to the nearest 5%, except for those situations in which the average PCT is less than one. In those cases, 1% is used as the average PCT and 2.5% is used as the maximum PCT. EPA uses a maximum PCT for acute dietary risk analysis. The maximum PCT figure is the highest observed maximum value reported within the recent 6 years of available public and private market survey data for the existing use and rounded up to the nearest multiple of 5%.
The Agency believes that the three conditions discussed in Unit III.C.1.iv. have been met. With respect to Condition a, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions b and c, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available reliable information on the regional consumption of food to which chemical name may be applied in a particular area.
2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment
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for thiram in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of thiram. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.
Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of thiram for acute exposures are 0.0478 parts per billion (ppb) and 0.0025 ppb for chronic exposures (for non-cancer assessments) for surface water. Ground water sources were not included (for acute or chronic exposures), as the EDWCs for ground water are minimal in comparison to those for surface water. Surface water EDWCs were incorporated in DEEM-FCID into the food categories ``water, direct, all sources'' and ``water, indirect, all sources'' for the dietary assessments.
3. From non-dietary exposure. The term ``residential exposure'' is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).
Thiram is not available for sale or use by homeowner applicators; therefore, there are no residential handler exposure scenarios applicable to thiram. However, there is potential for residential post-
application dermal exposure from treated golf course greens and tees. Residential exposures resulting from dermal contact with thiram-treated turf were assessed for children 6 to TM, acute dietary exposure at the 99.9th exposure percentile is estimated at 0.020104 mg/kg bw/day for the general U.S. population (3.1% of the aPAD) and 0.010887 mg/kg bw/day (78% of the aPAD) for females 13-49 years old, the population subgroup with the highest estimated acute dietary exposure to thiram.
2. Chronic risk. The chronic aggregate risk assessment takes into account exposure estimates from dietary consumption of thiram (food and drinking water). Dietary risk estimates were determined considering exposures from food and drinking water using EDWCs for surface water sources. Using DEEM-FCIDTM, dietary exposure is estimated at 0.001384 mg/kg bw/day for the general U.S. population (9.2% of the cPAD) and 0.008369 mg/kg bw/day (56% of the cPAD) for children 1-2 years old, the population subgroup with the highest estimated chronic dietary exposure to thiram.
3. Short-term and Intermediate-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level).
In aggregating short- and intermediate-term risk, the Agency routinely combines background chronic dietary exposure (food + water) with short/intermediate-term residential exposure (dermal only). The combined exposure may then be used to calculate an MOE for aggregate risk. Using the golfer scenario for adult males, adult females, and children >6 years old, combined with the applicable subpopulation with the greatest dietary exposure, the total short/intermediate-term food and residential aggregate MOEs are 600, 600, and 370, respectively. As these MOEs are greater than 100, the short- and intermediate-term aggregate risks do not exceed the Agency's LOC. For children
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