Pesticides; tolerances in food, animal feeds, and raw agricultural commodities: Bentazone,
[Federal Register: September 17, 2001 (Volume 66, Number 180)]
[Rules and Regulations]
[Page 48003-48011]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17se01-8]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-301172; FRL-6803-2]
RIN 2070-AB78
Bentazon; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes a tolerance for combined residues of bentazon (3-isopropyl-1H-2,1,3-Benzothiadiazin-4(3H)-one-2,2- dioxide) and its 6- and 8-hydroxy metabolites in or on Flax, seed at 1.0 ppm. BASF Corporation, Agricultural Products Division requested this tolerance under the Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality Protection Act of 1996.
DATES: This regulation is effective September 17, 2001. Objections and requests for hearings, identified by docket control number OPP-301172, must be received by EPA on or before November 16, 2001.
ADDRESSES: Written objections and hearing requests may be submitted by mail, in person, or by courier. Please follow the detailed instructions for each method as provided in Unit VI. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, your objections and hearing requests must identify docket control number OPP-301172 in the subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: By mail: Joanne I. Miller, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460; telephone number: 703-305-6224; and e-mail address: miller.joanne@epa.gov.
SUPPLEMENTARY INFORMATION:
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General Information
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Does this Action Apply to Me?
You may be affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to:
Examples of Potentially Categories
NAICS Affected Entities
Industry
111 Crop production 112 Animal production 311 Food manufacturing 32532 Pesticide manufacturing
This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.
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How Can I Get Additional Information, Including Copies of this Document and Other Related Documents?
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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://
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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 theFederal Register listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/ nara/cfr/cfrhtml_180/Title_40/40cfr180_00.html, a beta site currently under development.
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In person. The Agency has established an official record for this action under docket control number OPP-301172. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., 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.
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Background and Statutory Findings
In the Federal Register of August 17, 1998 (63 FR 43937)(FRL-6018- 2), EPA issued a notice pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170) announcing the filing of a pesticide petition (PP 6F4640, 3F4270) for tolerance by BASF Corporation, Agricultural Products Division, P.O 13528, Research Triangle Park, NC 27709-35281. This notice included a summary of the petition prepared by BASF Corporation, the registrant. There were no comments received in response to the notice of filing.
The petition requested that 40 CFR 180.355(a) be amended by establishing a tolerance for combined residues of the herbicide bentazon, (3-isopropyl-1H-2,1,3-benzothiadiazin-4(3H)-one-2,2-dioxide and its 6- and 8-hydroxy metabolites, in or on Flax, seed at 1.0 part per million (ppm).
Section 408(b)(2)(A)(i) of the 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) 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) 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....''
EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).
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Aggregate Risk Assessment and Determination of Safety
Consistent with 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, consistent with section 408(b)(2), for a tolerance for combined residues of bentazon on Flax, seed at 1.0 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance 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. The nature of the toxic effects caused by bentazon are discussed in the Federal Register of March 8, 2000 (65 FR 12122)(FRL- 6492-7) as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies reviewed.
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Toxicological Endpoints
The NOAEL from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the LOAEL is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor (UF) is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intra species differences.
For dietary risk assessment (other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose (acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by the appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is retained due to concerns unique to the FQPA, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to accommodate this type of FQPA Safety Factor.
For non-dietary risk assessments (other than cancer) the UF is used to determine the LOC. For example, when 100 is the appropriate UF (10X to account for interspecies differences and 10X for intraspecies differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and compared to the LOC.
The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk is expressed as 1 x 10-\6\ or one in a million). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non-linear approach, a ``point of departure'' is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure (MOEcancer= point
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of departure/exposures) is calculated. A summary of the toxicological endpoints for bentazon used for human risk assessment is shown in the following Table 1:
Table 1.--Summary of Toxicological Dose and Endpoints for bentazon for Use in Human Risk Assessment
Exposure Scenario
Dose (mg/kg/day)
Endpoint
Study
Acute Dietary (Females 13-50 years Developmental NOAEL = Increased postimplantation Developmental old)
100
loss, skeletal variations, Toxicity-Rat UF = 100............. and reduced weight of fetuses FQPA SF\*\ = 10...... at a LOAEL of 250 mg/kg/day.
Acute RfD = 1 mg/kg
Acute PAD = 0.1 mg/kg
Acute Dietary (General
None
A dose and non-developmental None Population)
endpoint attributable to a single exposure were not identified in oral toxicity studies.
Risk Assessment is NOT required.
Chronic Dietary
NOAEL = 3.2
A dose-dependent presence of One-Year Feeding UF = 100............. feces with red areas in dogs Study-Dog FQPA SF = 10......... at 13.1 mg/kg/day (LOAEL) and 52.3 mg/kg/day (HDT), and slight to severe anemia at the high dose.
Chronic RfD = 0.03 mg/ kg/day
Chronic PAD = 0.003 mg/kg/day
Short-Term (Dermal)
No systemic toxicity was seen at the Limit-Dose in a 21-day dermal toxicity study in rabbits. Therefore, this risk assessment is NOT required.
Intermediate-Term (Dermal)\a\ Oral NOAEL = 13.1 The presence of feces with red One-Year Feeding MOE = 100
areas seen in dogs at weeks Study-Dog (Occupational).
4, 6, and 12 at a LOAEL of MOE = 1,000
52.3 mg/kg/day. (Residential).
Long-Term (Dermal)\a,d\
Oral NOAEL = 3.2 A dose-dependent presence of One-Year Feeding MOE = 100
feces with red areas in dogs Study-Dog (Occupational).
at a LOAEL of 13.1 mg/kg/day MOE = 1,000
(seen at week 33) and 52.3 mg/ (Residential).
kg/day (HDT), and slight to severe anemia at the high dose.
Short Term (Inhalation)\b\
Oral Developmental Increased postimplantation Developmental NOAEL = 100
loss, skeletal variations, Toxicity-Rat MOE = 100
and reduced weight of fetuses (Occupational).
at a LOAEL of 250 mg/kg/day. MOE = 1,000 (Residential).
Intermediate Term
Oral NOAEL = 13.1 The presence of feces with red One-Year Feeding (Inhalation)\c,d\
MOE = 100
areas seen in dogs at weeks Study-Dog (Occupational).
4, 6, and 12 at a LOAEL of MOE = 1,000
52.3 mg/kg/day. (Residential).
Long Term (Inhalation)\c,d\
Oral NOAEL=3.2
A dose-dependent presence of One Year Feeding MOE = 100
feces with red areas in dogs Study-Dog (Occupational).
at a LOAEL of 13.1 mg/kg/day MOE = 1,000
(seen at week 33) and 52.3 mg/ (Residential).
kg/day (HDT), and slight to severe anemia at the high dose.
\a\ A dermal absorption factor of 2% should be used for route-to-route extrapolation. \b\ An inhalation absorption factor of 100% should be used for route-to-route extrapolation for short-term inhalation risk assessment. \c\ An inhalation absorption factor of 100% and a dermal absorption factor of 2% should be used for route-to- route extrapolation for intermediate- and long-term risk assessments. \d\ Although long-term dermal and inhalation endpoints were selected, the current use pattern does not indicate a concern for long-term dermal or inhalation exposure potential. Long-term dermal and inhalation risk assessments were not conducted. \*\ * The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique to the FQPA.
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Exposure Assessment
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Dietary exposure from food and feed uses. Tolerances have been established (40 CFR 180.355(a)) for the combined residues of bentazon (3-isopropyl-1H-2,1,3-benzothiadiazin-4 (3H)-one-2,2-dioxide) and its 6- and 8-hydroxy metabolites in or on a variety of raw agricultural commodities. Tolerances are also established for the combined residues of the herbicide bentazon (3-isopropyl-1H-2,1,3-benzothiadiazin-4(3H)- one-2,2-dioxide) and its metabolite 2-amino-N-isopropyl benzamide (AIBA) in or on the following food commodities: for cattle, goats, hogs, poultry, and sheep, fat, meat-by-products, and meat, with a tolerance of 0.05 ppm, for eggs, with a tolerance of 0.05 ppm, and milk, with a tolerance of 0.02 ppm. Risk assessments were conducted by EPA to assess dietary exposures from bentazon in food as follows:
i. Acute exposure. Acute dietary 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 one day or single exposure. The Dietary Exposure Evaluation Model (DEEM) analysis evaluated the individual food
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consumption as reported by respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the acute exposure assessments: An acute analysis was performed using tolerance level residues, 100% crop treated (CT), and DEEMdefault processing factors for all commodities.
ii. Chronic exposure. In conducting this chronic dietary risk assessment the DEEManalysis evaluated the individual food consumption as reported by respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: an Anticipated Residue was calculated for succulent peas using average residue values (1.08 ppm) from the submitted crop field trials. Percent CT information for several commodities was used. For all other commodities 100% CT was assumed. DEEMdefault processing factors were used for all commodities.
iii. Cancer. Bentazon has been classified as a Group E chemical (evidence of non-carcinogenicity for humans) based upon lack of evidence of carcinogenicity in rats and mice.
iv. Anticipated residue and percent crop treated information. Section 408(b)(2)(E) authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide chemicals that have been measured in food. If EPA relies on such information, EPA must require 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. Following the initial data submission, EPA is authorized to require similar data on a time frame it deems appropriate. As required by section 408(b)(2)(E), EPA will issue a data call-in for information relating to anticipated residues to be submitted no later than 5 years from the date of issuance of this tolerance.
Section 408(b)(2)(F) states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if the Agency can make the following findings: Condition 1, that 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 such pesticide residue; Condition 2, that the exposure estimate does not underestimate exposure for any significant subpopulation group; and Condition 3, if 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 percent crop treated (PCT) as required by section 408(b)(2)(F), EPA may require registrants to submit data on PCT.
The Agency used percent crop treated (PCT) information as follows.
For the acute analysis, tolerance level residues and 100% CT was assumed for all commodities. For the chronic analysis, PCT information was used for mint (25%), sweet corn (13%), snap beans (15%), green peas (13%), dry beans and peas (17%), alfalfa (0%), sorghum (0%), corn (1%), rice (5%), peanuts (27%), soybeans (12%), and potatoes (0%). For alfalfa, sorghum and potatoes, which have %CT estimates of zero, a value of 1% CT was used in the analysis. For all crops other than mint, sweet corn, snap beans, green peas, dry bean and peas, alfalfa, sorghum, corn, rice, peanuts, soybeans and potatoes, 100% CT was used, and tolerance level residues were used for all crops.
The Agency believes that the three conditions listed above have been met. With respect to Condition 1, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. EPA uses a weighted average PCT for chronic dietary exposure estimates. This weighted average PCT figure is derived by averaging State-level data for a period of up to 10 years, and weighting for the more robust and recent data. A weighted average of the PCT reasonably represents a person's dietary exposure over a lifetime, and is unlikely to underestimate exposure to an individual because of the fact that pesticide use patterns (both regionally and nationally) tend to change continuously over time, such that an individual is unlikely to be exposed to more than the average PCT over a lifetime. For acute dietary exposure estimates, EPA uses an estimated maximum PCT. The exposure estimates resulting from this approach reasonably represent the highest levels to which an individual could be exposed, and are unlikely to underestimate an individual's acute dietary exposure. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions 2 and 3, 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 information on the regional consumption of food to which bentazon may be applied in a particular area.
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Dietary exposure from drinking water. Degradation products of bentazon in the tolerance expression are 8-hydroxy bentazon (plants), 6-hydroxy bentazon (plants), and AIBA (animals). AIBA was the only degradation product in the tolerance expression which was found in standard laboratory environmental fate studies. Therefore, the water assessment was conducted for bentazon and AIBA.
SCI-GROW (Screening Concentration in Ground Water) modeling indicates that bentazon residue (bentazon + AIBA) concentrations in ground water used as drinking water are not likely to exceed 4.25 parts per billion (ppb). As reported in the 1994 bentazon RED, bentazon concentrations (excluding degradation products) in ground water are higher (20 to 120 ppb) when compared to SCI-GROW model predictions. The maximum concentration of bentazon (120 ppb) was observed in shallow groundwater samples near greens and tees in a United States Geological Survey (USGS) and the Florida Department of Environmental Protection (FDEP) monitoring study. Since the monitoring data indicate a higher concentration than the SCI-GROW screening model, EPA used the 20 ppb as the representative national Tier 1 ground water screening concentration for bentazon.
Tier II PRZM-EXAMS modeling indicates that cumulative bentazon residue (bentazon + AIBA) concentrations in surface water to be used as screening concentrations for bentazon are 41 ppb for the 1 in 10 year peak (acute) and 8 ppb for the 36 year annual mean (chronic).
A preliminary review of the National Water Quality Assessment Program (NAWQA) monitoring data suggest that bentazon concentrations in surface water are substantially lower than
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model predictions. There are no surface water monitoring data for bentazon degradation products. Bentazon has been detected in 37 agricultural streams at a concentration of 0.05 ppb for the 95th percentile and estimated maximum concentration of 5 ppb and 14 integrator sites on large streams at a concentration of 0.15 ppb for the 95th percentile and estimated maximum concentration of 2.8 g/L. Bentazon was not detected (less than Method of Detection Limit) in urban streams (http://water.wr.usgs.gov/pnsp/gwsw1.html, 3/ 27/98). Bentazon is not reported in the latest summary of the NAWQA monitoring data (Larson, et al., ``Pesticides in Streams of the United States-Initial Results from the National Water-Quality Assessment Program Water Resources Investigations Report'' 98-4222). Bentazon degradation products were not part of the analysis in the NAWQA monitoring program.
The Agency uses the Generic Estimated Environmental Concentration (GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS) to estimate pesticide concentrations in surface water and SCI-GROW, which predicts pesticide concentrations in groundwater. In general, EPA will use GENEEC (a tier 1 model) before using PRZM/EXAMS (a tier 2 model) for a screening-level assessment for surface water. The GENEEC model is a subset of the PRZM/EXAMS model that uses a specific high-end runoff scenario for pesticides. GENEEC incorporates a farm pond scenario, while PRZM/EXAMS incorporate an index reservoir environment in place of the previous pond scenario. The PRZM/EXAMS model includes a percent crop area factor as an adjustment to account for the maximum percent crop coverage within a watershed or drainage basin.
None of these models include consideration of the impact processing (mixing, dilution, or treatment) of raw water for distribution as drinking water would likely have on the removal of pesticides from the source water. The primary use of these models by the Agency at this stage is to provide a coarse screen for sorting out pesticides for which it is highly unlikely that drinking water concentrations would ever exceed human health levels of concern.
Since the models used are considered to be screening tools in the risk assessment process, the Agency does not use EECs from these models to quantify drinking water exposure and risk as a %RfD or %PAD. Instead, drinking water levels of comparison (DWLOCs) are calculated and used as a point of comparison against the model estimates of a pesticide's concentration in water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food, and from residential uses. Since DWLOCs address total aggregate exposure to bentazon they are further discussed in the aggregate risk sections below.
Based on the PRZM/EXAMS and SCI-GROW models the EECs of bentazon for acute exposures are estimated to be 41 ppb for surface water and 20 ppb for ground water. The EECs for chronic exposures are estimated to be 8 ppb for surface water and 20 ppb for ground water.
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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).
Bentazon is currently registered for use on the following residential non-dietary sites: turf and ornamentals. The risk assessment was conducted using the following residential exposure assumptions: Although bentazon is a registered herbicide for use on turf and ornamentals, short-term non-dietary ingestion exposure for toddlers is not assessed since EPA determined that there is no acute dietary or oral endpoint applicable to infants and children.
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Cumulative exposure to substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider ``available information'' concerning the cumulative effects of a particular pesticide's residues and ``other substances that have a common mechanism of toxicity.''
EPA does not have, at this time, available data to determine whether bentazon has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, bentazon does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that bentazon has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the final rule for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).
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Safety Factor for Infants and Children
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In general. FFDCA section 408 provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base on toxicity and exposure unless EPA determines that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a margin of exposure (MOE) analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans.
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Prenatal and postnatal sensitivity. Both the rat developmental and reproductive toxicity studies indicate increased susceptibility from in utero and post natal exposure to bentazon. The available developmental toxicity data in rabbits did not provide an indication of increased susceptibility from in utero exposure to bentazon.
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Conclusion. There is a complete toxicity data base for bentazon and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. The FQPA safety factor for protection of infants and children will be retained at 10x in assessing the risk posed by bentazon. This decision is based on:
i. Evidence of increased susceptibility following in utero exposure to bentazon in the prenatal developmental toxicity study in rats in the absence of maternal toxicity.
ii. Quantitative evidence of increased susceptibility following prenatal/postnatal exposure to bentazon in the 2-generation reproduction study in rats.
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Aggregate Risks and Determination of Safety
To estimate total aggregate exposure to a pesticide from food, drinking water, and residential uses, the Agency calculates DWLOCs which are used as a point of comparison against the model estimates of a pesticide's concentration in water (EECs). DWLOC values are not regulatory standards for drinking water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food and residential uses. In calculating a DWLOC, the Agency determines how much of the acceptable exposure (i.e., the PAD) is available for exposure through drinking water e.g., allowable chronic water
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exposure (mg/kg/day) = cPAD - (average food + residential exposure). This allowable exposure through drinking water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water consumption, and body weights. Default body weights and consumption values as used by the USEPA Office of Water are used to calculate DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg (child). Default body weights and drinking water consumption values vary on an individual basis. This variation will be taken into account in more refined screening-level and quantitative drinking water exposure assessments. Different populations will have different DWLOCs. Generally, a DWLOC is calculated for each type of risk assessment used: acute, short-term, intermediate-term, chronic, and cancer.
When EECs for surface water and groundwater are less than the calculated DWLOCs, the USEPA Office of Pesticide Programs (OPP) concludes with reasonable certainty that exposures to the pesticide in drinking water (when considered along with other sources of exposure for which OPP has reliable data) would not result in unacceptable levels of aggregate human health risk at this time. Because OPP considers the aggregate risk resulting from multiple exposure pathways associated with a pesticide's uses, levels of comparison in drinking water may vary as those uses change. If new uses are added in the future, OPP will reassess the potential impacts of residues of the pesticide in drinking water as a part of the aggregate risk assessment process.
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Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food to bentazon will occupy 2% of the aPAD for females 13 years and older. No appropriate end-point was available to quantitate risk to the general U.S. population from a single dose administration of bentazon. In addition, there is potential for acute dietary exposure to bentazon in drinking water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the aPAD, as shown in the following Table 2:
Table 2.--Aggregate Risk Assessment for Acute Exposure to Bentazon
Surface Ground Acute Population Subgroup\1\
aPAD (mg/ % aPAD Water EEC Water DWLOC\2\ kg)
(Food) (ppb) EEC(ppb) (ppb)
Females 13-50 years old
0.1
2
41
20
2,900
\1\ Population subgroup chosen was the female subgroup with the highest food exposure (60 kg. body weight assumed). \2\ Allowable Drinking Water Exposure (mg/kg/day) = aPAD (mg/kg/day) - Dietary Exposure from DEEM (mg/kg/day)
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Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to bentazon from food will utilize less than or equal to 10% of the cPAD for the U.S. population, 12% of the cPAD for non-nursing infant and 28% of the cPAD for children 1-6 years old.
Based on the use pattern, chronic residential exposure to residues of bentazon is not expected. In addition, there is potential for chronic dietary exposure to bentazon in drinking water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in the following Table 3:
Table 3.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Bentazon
Surface Ground cPAD mg/kg/ %
Water
Water Chronic Population Subgroup\1\
day cPAD(Food) EEC\2\ EEC\2\ DWLOC\3\ (ppb)
(ppb)
(ppb)
U.S. Population (48 states)
0.003
10
8
20
95 Non-nursing infants
0.003
12
8
20
26 Children 1-6 years old
0.003
28
8
20
22 Children 7-12 years old
0.003
16
8
20
26 Females 13-50 years old
0.003
6.3
8
20
95 Males 13-19 years old
0.003
10
8
20
95 Males 20+ years old
0.003
6.7
8
20
98 Seniors 55+ years old
0.003
6.2
8
20
99
\1\ Population subgroups chosen were U.S. population (70 kg. body weight assumed), the female subgroup with the highest food exposure (60 kg. body weight assumed),the infant/child subgroup with the highest food exposure (10 kg body weight assumed), and the other general population subgroups (70 kg body weight assumed) which have higher dietary exposure than the U.S. population. \2\ Allowable Drinking Water Exposure (mg/kg/day) = cPAD (mg/kg/day) - Dietary Exposure from DEEM (mg/kg/day) \3\ DWLOC(g/L) = maximum water exposure (mg/kg/day) x body weight(kg) water consumption (L) x 10-3mg/g
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Short-term risk. Short-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level).
Bentazon is currently registered for use that could result in short-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and short-term exposures for bentazon.
Using the exposure assumptions described in this unit for short- term exposures, EPA has concluded that food and residential exposures aggregated result in aggregate MOEs of 250,000 for females 13-50 years old. These aggregate MOEs do not exceed the Agency's level of concern for aggregate exposure to food and residential uses. In addition, short-term DWLOCs were calculated and compared to the EECs for chronic exposure of bentazon in ground and surface water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect short-term aggregate exposure to exceed the Agency's level of
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concern, as shown in the following Table 4:
Table 4.--Aggregate Risk Assessment for Short-Term Exposure to Bentazon
Aggregate Aggregate
Level of Surface Water Ground Water Short-Term Population Subgroup
MOE\1\ (Food + Concern\3\ EEC\4\ (ppb) EEC\4\ (ppb) DWLOC\5\ (ppb) Residential)\2\ (LOC)
Females 13-50 years old
250,000
1,000
8
20
3,000
\1\ Residential Exposure = Oral exposure + Dermal exposure + Inhalation Exposure \2\ Maximum Exposure (mg/kg/day) = NOAEL/Target MOE \3\ Basis for the target MOE: inter- and intra- species UFs totaling 100 + 10X FQPA SF \4\ The crop producing the highest level was used. \5\ DWLOC(g/L = maximum water exposure (mg/kg/day) x body weight (kg) (60 kg. body weight assumed) 2 (L) x 10-3mg/g \*\ Aggregate MOE = NOAEL (Avg Food Exposure + Residential Exposure) \*\ Maximum Water Exposure (mg/kg/day) = Target Maximum Exposure - (Food Exposure + Residential Expoxure)
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Intermediate-term risk. Intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level).
Bentazon is currently registered for use(s) that could result in intermediate-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and intermediate-term exposures for bentazon.
Using the exposure assumptions described in this unit for intermediate-term exposures, EPA has concluded that food and residential exposures aggregated result in aggregate MOEs of 8,200 for males 20+ years old, females 13-50 years old and males 13-19 years old and 1,900 for children 1-6 years old. These aggregate MOEs do not exceed the Agency's level of concern for aggregate exposure to food and residential uses. In addition, intermediate-term DWLOCs were calculated and compared to the EECs for chronic exposure of bentazon in ground and surface water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect intermediate-term aggregate exposure to exceed the Agency's level of concern, as shown in the following Table 5:
Table 5.--Aggregate Risk Assessment for Intermediate-Term Exposure to Bentazon
Aggregate Surface Ground Aggregate Level of Water
Water Intermediate- Population Subgroup
MOE\1\ (Food + Concern\3\ EEC\4\ EEC\4\ Term DWLOC\5\ Residential)\2\ (LOC)
(ppb)
(ppb)
(ppb)
Males 20+ years old
8,200
1,000
8
20
400 Females 13-50 years old
8,200
1,000
8
20
340 Children 1-6 years old
1,900
1,000
8
20
64 Males 13-19 years old
8,200
1,000
8
20
400
\1\ Residential Exposure = Oral exposure + Dermal exposure + Inhalation Exposure \2\ Maximum Exposure (mg/kg/day) = NOAEL/Target MOE \3\ Basis for the target MOE: inter- and intra- species UFs totaling 100 x 10X (FQPA SF) \4\ The crop producing the highest level was used. \5\ DWLOC(g/L) = maximum water exposure (mg/kg/day) x body weight (kg)water consumption (L) x 10-3mg/g \*\ Aggregate MOE = NOAEL(Avg Food Exposure + Residential Exposure) \*\ Maximum Water Exposure (mg/kg/day) = Target Maximum Exposure - (Food Exposure + Residential Exposure)
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Aggregate cancer risk for U.S. population. Bentazon has been classified as a Group E chemical (evidence of non-carcinogenicity for humans) based upon lack of evidence of carcinogenicity in rats and mice. Therefore no cancer risk is expected.
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Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to bentazon residues.
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Other Considerations
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Analytical Enforcement Methodology
Adequate enforcement methods are available for the determination of residues of bentazon and its 6- and 8-hydroxy metabolites in/on plant commodities. The Pesticide Analytical Method Volume II (PAM II) lists Method II, a GLC method with flame photometric detection for the determination of bentazon and its hydroxy metabolites in/on corn, rice, and soybeans; the limit of detection (LOD) for each compound is 0.05 ppm. Method III, modified from Method II, is available for the determination of bentazon and its hydroxy metabolites in/on peanuts and seed and pod vegetables with a LOD of 0.05 ppm for each compound. These methods are adequate to enforce the tolerances associated with this petition.
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International Residue Limits
There is a Codex maximum residue limit (MRL) of 0.1 ppm for bentazon and its metabolites established in/on linseed. Therefore, a compatibility issue is relevant to the proposed flax, seed tolerance. Harmonization of the U.S. tolerance will not be possible as the use pattern proposed in this petition may result in residues which exceed the Codex MRL.
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Conditions
Analytical analyses of bentazon and its regulated metabolites using the FDA multiresidue protocols are required as part of the conditional registration of bentazon on flax.
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Conclusion
Therefore, the tolerance is established for combined residues of bentazon, (3-isopropyl-H-2,1,3-Benzothiadiazin-4 (3H)-one-2,2-dioxide) and its 6- and 8-hydroxy metabolites in or on flax, seed at 1.0 ppm.
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Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA of 1996, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) provides essentially the same process for persons to ``object'' to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408(d), as was provided in the old FFDCA sections 408 and 409. However, the period for filing objections is now 60 days, rather than 30 days.
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What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket control number OPP-301172 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before November 16, 2001.
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Filing the request. Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections (40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues(s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector (40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. You may also deliver your request to the Office of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., Washington, DC 20460. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (202) 260-4865.
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Tolerance fee payment. If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or request a waiver of that fee pursuant to 40 CFR 180.33(m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.'' For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov, or by mailing a request for information to Mr. Tompkins at Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
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Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.2. Mail your copies, identified by docket control number OPP-301172, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.2. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.
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When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32).
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Regulatory Assessment Requirements
This final rule establishes a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any other Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary
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consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure ``meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.'' ``Policies that have federalism implications'' is defined in the Executive Order to include regulations that have ``substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.'' This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). For these same reasons, the Agency has determined that this rule does not have any tribal implications as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure ``meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.'' ``Policies that have tribal implications'' is defined in the Executive Order to include regulations that have ``substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.'' This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.
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Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Dated: September 7, 2001. Peter Caulkins, Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
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The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346(a) and 371.
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Section 180.355 is amended by revising the term ``commodity'' in the introductory text to paragraph (a) to read ``commodities'' and by alphabetically adding the commodity ``flax, seed'' to the table in paragraph (a)(1) to read as follows:
Sec. 180.355 Bentazon; tolerances for residues.
(a) * * *
Commodity
Parts per million
*
*
*
*
* Flax, seed.....................................
1.0 *
*
*
*
*
* * * * *
[FR Doc. 01-23085Filed9-14-01; 8:45 am]
BILLING CODE 6560-50-S
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