Environmental Protection Agency (EPA).
This regulation establishes a tolerance for residues of propyl[3-(dimethylamino)propyl]carbamate monohydrochloride known as propamocarb hydrochloride in or on potatoes. Aventis CropScience USA LP requested this tolerance under the Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality Protection Act of 1996.
This regulation is effective September 29, 2000. Objections and requests for hearings, identified by docket control number OPP-301057, must be received by EPA on or before November 28, 2000.
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-301057 in the subject line on the first page of your response.Start Further Info
FOR FURTHER INFORMATION CONTACT
By mail: Mary L. Waller, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460; telephone number: (703) 308-9354; and e-mail address: Waller.Mary@epa.gov.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 an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to:
|Categories||NAICS codes||Examples of Potentially Affected Entities|
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.
B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents?
1. 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 Start Printed Page 58391Documents.” You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm.
2. In person. The Agency has established an official record for this action under docket control number OPP-301057. 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.
II. Background and Statutory Findings
In the Federal Register of March 12, 1997 (62 FR 11433) (FRL-5589-7), 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) for tolerance by Aventis CropScience USA LP, 2 T.W. Alexander Drive, Research Triangle Park, NC 27709. This notice included a summary of the petition prepared by Aventis CropScience, the registrant. There were no comments received in response to the notice of filing.
The petition requested that 40 CFR 180.499 be amended by establishing a tolerance for residues of the fungicide propyl[3-(dimethylamino)propyl]carbamate monohydrochloride, known as propamocarb hydrochloride, in or on potatoes, and the following livestock commodities: meat, meat byproducts, fat and milk of cattle, goats, hogs, horses and sheep at 0.05 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).
III. 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 residues of propyl[3-(dimethylamino)propyl]carbamate monohydrochloride on potatoes at 0.06 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows.
A. 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 propyl[3-(dimethylamino)propyl]carbamate monohydrochloride are discussed in the following Table 1 as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies reviewed.
|Guideline No.||Study type||Results|
|870.3100||90-Day oral toxicity in rodents||NOAEL = 363 mg/kg/day in females and 646 mg/kg/day in males. LOAEL = 716 mg/kg/day in females, based on decreased body weight and body weight gain and decreased food efficiency.|
|LOAEL in males is 1363 mg/kg/day based on decreased food efficiency|
|870.3150||90-Day oral toxicity in nonrodents||NOAEL was not achieved.|
|LOAEL = 22.75 mg/kg/day based upon body weight gain depression, decreased food efficiency and focal or multi-focal chronic erosive gastritis|
|870.3200||21/28-Day dermal toxicity in rabbits||NOAEL ≥ 150 mg/kg/day for both sexes.|
|LOAEL = 525 mg/kg/day based on dose-related skin irritation and depressed body weight gain|
|870.3250||90-Day dermal toxicity in rats||NA|
|870.3465||90-Day inhalation toxicity in rats||NA|
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|870.3700a||Prenatal developmental toxicity in rats||Maternal NOAEL = 221 mg/kg/day. LOAEL = 740 mg/kg/day based on mortality. Developmental NOAEL = 221 mg/kg/day.|
|LOAEL = 740 mg/kg/day based on GD 20 fetal death and a possible increase in minor skeletal anomalies.|
|870.3700b||Prenatal developmental toxicity in rabbits||Maternal NOAEL = 150 mg/kg/day. LOAEL = 300 mg /kg/day based on decreased body weight gains for GD 6-18 and possible increased abortions. Developmental NOAEL = 150 mg/kg/day.|
|LOAEL = 300 mg/kg/day based on increased post-implantation loss.|
|870.3800||Reproduction and fertility effects in rats||Parental/Systemic NOAEL = 65.41 mg/kg/day for males and 76.78 mg/kg/day for females. LOAEL = 406.69 mg/kg/day for males and 467.13 mg/kg/day for females based on decreased body weights. Reproductive/Offspring NOAEL = 65.41 mg/kg/day for males and 76.78 mg/kg/day for females.|
|LOAEL = 406.69 mg/kg/day for males and 467.13 mg/kg/day for females based on reduced pup weights|
|870.4100a||Chronic toxicity in rodents||NOAEL = ≥25.6 mg/kg/day.|
|LOAEL = >25.6 mg/kg/day. There were no signs of toxicity attributable to treatment at any dose level|
|870.4100b||Chronic toxicity in dogs||NOAEL was not achieved.|
|LOAEL = 22.75 mg/kg/day based upon body weight gain depression, decreased food efficiency and focal or multi-focal chronic erosive gastritis|
|870.4200a||Carcinogenicity in rats||NOAEL = 84 mg/kg/day in males, 112 mg/kg/day in females.|
|LOAEL = 682 mg/kg/day in males, 871 mg/kg/day in females based on decreased body weight and body weight gain, decreased food consumption, and an increased incidence of vacuolation of choroid plexus ependymal cells in the brain in both sexes and decreased water consumption in the females. No evidence of carcinogenicity|
|870.4200b||Carcinogenicity in mice||NOAEL = 12 mg/kg/day in females and ≥ 690.0 mg/kg/day in males.|
|LOAEL = 95 mg/kg/day in females based on decreased body weight and body weight gains. No evidence of carcinogenicity|
|870.5100||Gene Mutation: reverse gene mutation assay in bacteria||There was no evidence of induced mutant colonies over background|
|870.5375||Cytogenetics: in vitro mammalian cytogenetics assay||Increases in aberrant metaphases were within the historical control range|
|870.5395||Bone marrow micronucleus assay||There was no significant increase in the frequency of micronucleated polychromatic erythrocytes in bone marrow at any dose tested.|
|870.5395||Bone marrow micronucleus assay||There was no significant increase in the frequency of micronucleated polychromatic erythrocytes in bone marrow after any treatment time.|
|870.5575||Other Genotoxicity: Saccharomyces cerevisiae, mitotic recombination, gene conversion assay||There was no evidence of gene conversion in the tested strains with activation.|
|870.5575||Saccharomyces cerevisiae, mitotic recombination, gene conversion assay||There was no evidence of gene conversion in the tested strains without activation.|
|870.5575||Saccharomyces cerevisiae, mitotic recombination, gene conversion assay||Under the conditions of the study there was no evidence of gene conversion.|
|Start Printed Page 58393|
|870.6200a||Acute neurotoxicity screening battery in rats||NOAEL = 200 mg/kg/day.|
|LOAEL = 2000 mg/kg/day based on soiled fur coat (both sexes) and decreased motor activity 8 hours post-dosing (females only)|
|870.6200b||Subchronic neurotoxicity screening battery in rats||NOAEL = 1320.8 mg/kg/day in males and 1485.6 mg/kg/day in females.|
|LOAEL = not observed|
|870.6300||Developmental neurotoxicity in rats||NA|
|870.7485||Metabolism in rats||A higher dose (at least equivalent to levels of human exposure) should have been tested, and the metabolites should have been identified.|
|NA||Special studies||The cholinesterase inhibition studies were of questionable quality. The chemical does not cause any appreciable inhibition of cholinesterase.|
B. Toxicological Endpoints
The dose at which 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 dose at which the LOAEL of concern are identified 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 intraspecies 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 of departure/exposures) is calculated. A summary of the toxicological endpoints for propyl[3-(dimethylamino)propyl]carbamate monohydrochloride used for human risk assessment is shown in the following Table 2:
|Exposure scenario||Dose used in risk assessment, UF||FQPA SF2 and level of concern for risk assessment||Study and toxicological effects|
|Acute Dietary females 13-50 years of age||NOAEL = 150 mg ai/kg/day. UF = 100. Acute RfD = 1.5 mg ai/ kg/day.||FQPA SF = 1X. aPAD = acute RfD ÷ FQPA SF = 1.5 mg/kg/day||Developmental Toxicity Study—rabbit. Developmental LOAEL = 300 mg ai/kg/day based on increased post-implantation loss|
|Acute Dietary general population including infants and children||NOAEL = 200 mg ai/kg/day. UF = 100. Acute RfD = 2.0 mg/kg/day.||FQPA SF = 1X. aPAD = acute RfD ÷ FQPA SF = 2.0 mg/kg/day||Acute Neurotoxicity Screening Battery—rat. LOAEL = 2000 mg ai/kg/day based on decreased body weight gain and decreased motor activity|
|Start Printed Page 58394|
|Chronic Dietary all populations||NOAEL = 12 mg ai/kg/day. UF = 100. Chronic RfD = 0.12 mg/kg/day.||FQPA SF = 1X. cPAD = chronic RfD ÷ FQPA SF = 0.12 mg/kg/day||Carcinogenicity Study—mouse. LOAEL = 95 mg ai/kg/day based on decreased body weight and body weight gain in females|
|Short-Term (1-7 days) and Intermediate-Term (1 week-several months) Dermal (Occupational/Residential)||dermal study NOAEL = 150 mg ai/kg/day.||LOC for MOE = 100 (Occupational). LOC for MOE = 100 (Residential)||21-Day Dermal Toxicity Study—rabbit. LOAEL = 525 mg/kg/day based on decreased body weight gain in females|
|Short-Term (1-7 days) and Intermediate-Term (1 week-several months) Inhalation (Occupational/Residential)||inhalation (or oral) study NOAEL = 150 mg ai/kg/day (inhalation absorption rate = 100%)||LOC for MOE = 100 (Occupational). LOC for MOE = 100. (Residential)||Developmental Toxicity Study—rabbit. Developmental LOAEL = 300 mg ai/ kg/day based on increased post-implantation loss. Maternal LOAEL = 300 mg ai/kg/day based on decreased body weight gain|
|Cancer (oral, dermal, inhalation)||“not likely”||not applicable||Acceptable oral rat and mouse carcinogenicity studies; no evidence of carcinogenic or mutagenic potential.|
|1 UF = uncertainty factor, FQPA SF = FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect level, PAD = population adjusted dose (a = acute, c = chronic) RfD = reference dose, MOE = margin of exposure, LOC = level of concern|
|2 The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique to the FQPA.|
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In addition to the currently proposed tolerance for potatoes, tolerances have been established under the section 18 program (40 CFR 180.499) for the residues of propyl[3-(dimethylamino)propyl]carbamate monohydrochloride, in or on the raw agricultural commodity, potatoes and tomatoes. Risk assessments were conducted by EPA to assess dietary exposures from propyl[3-(dimethylamino)propyl]carbamate monohydrochloride 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 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: Tier 1 acute analyses were performed for females 13-50 years old and the general U.S. population (including infants and children); therefore, the acute risk was analyzed at the 95th percentile. The aPAD for females 13-50 years old and the general U.S. population (including infants and children) are 1.5 mg/kg/day and 2.0 mg/kg/day, respectively. For acute dietary risk estimates, EPA's level of concern is >100% aPAD. The results of the acute analysis indicate that the acute dietary risk estimates for the general U.S. population and all population subgroups (at the 95th percentile) associated with the proposed uses of propamocarb hydrochloride do not exceed EPA's level of concern.
ii. Chronic exposure. In conducting this chronic dietary risk assessment the DEEM® analysis 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: A Tier 1 chronic analysis was performed for the general U.S. population and all population subgroups. The cPAD for the general U.S. population and all subgroups is 0.12 mg/kg/day. For chronic dietary risk estimates, EPA's level of concern is >100% cPAD. The results of the chronic analysis indicate that the chronic dietary risk estimates for the general U.S. population and all population subgroups associated with the proposed uses of propamocarb hydrochloride do not exceed EPA's level of concern.
iii. Cancer. There is no concern for mutagenic potential, and there is no evidence of carcinogenic potential in either the rat or mouse. Propamocarb hydrochloride has been classified as “not likely to be carcinogenic in humans.” Therefore, a cancer dietary exposure analysis was not performed.
2. Dietary exposure from drinking water. The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for propyl[3-(dimethylamino)propyl]carbamate monohydrochloride in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the physical characteristics of propyl[3-(dimethylamino)propyl]carbamate monohydrochloride.
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 ground water. 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 Start Printed Page 58395drinking 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 estimated environmental concentrations (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 propyl[3-(dimethylamino)propyl]carbamate monohydrochloride they are further discussed in the aggregate risk sections below.
Based on the GENEEC and SCI-GROW models the EECs of propyl[3-(dimethylamino)propyl]carbamate monohydrochloride in surface water and ground water for acute exposures are estimated to be 1030 parts per billion (ppb) for surface water and 2.08 ppb for ground water. The EECs for chronic exposures are estimated to be 340 ppb for surface water and 2.08 ppb for ground water.
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).
Propyl[3-(dimethylamino)propyl]carbamate monohydrochloride is currently registered for use on the following residential non-dietary sites: turfgrass and ornamentals at residential, recreational and golf course sites. However, the usage information in the 1995 Reregistration Eligibility Decision (RED) for propamocarb hydrochloride and the label statement that only protected handlers may be present in the treated area during application, indicate that only commercial applicators will apply the registered end-use product Banol (EPA Registration Number 432-942, contains 66.5% propamocarb hydrochloride) mainly on golf courses and there will be no use on residential or recreational turf. The risk assessment was conducted using the following residential exposure assumptions: An MOE of 100 is adequate to ensure protection from propamocarb hydrochloride via the dermal and inhalation routes for residential exposures. The high-end scenario for residential post-application exposure is the golf course use. The post-application risk assessment is based on generic assumptions as specified by the newly proposed Residential Standard Operating Procedures (SOPs) and recommended approaches by Health Effects Division's (HED's) Exposure Science Advisory Committee. Short-term post-application exposures are expected for the adult and adolescent golfer. Golfer exposure is expected through minimal hand contact with the golf ball and dermal contact to the lower legs from treated plant surfaces. Since it is assumed that the adolescent golfer would have a proportionally similar exposure to adults, a dermal post-application assessment was performed for the adult golfer only. The calculated MOE for the golfer is 980 and, therefore, does not exceed EPA's level of concern. Since the short- and intermediate-term toxicological endpoints are the same, the golfer post-application exposure assessment is expected to provide adequate exposure estimates for both the short- and intermediate-term. In the event of intermediate-term exposure, propamocarb hydrochloride residues are expected to dissipate over time. Therefore, this assessment is expected to present a high-end conservative estimate of actual exposure.
4. 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 propyl[3-(dimethylamino)propyl]carbamate monohydrochloride 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, propyl[3-(dimethylamino)propyl]carbamate monohydrochloride 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 propyl[3-(dimethylamino)propyl]carbamate monohydrochloride 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).
D. Safety Factor for Infants and Children
1. Safety factor for infants and children—i. 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.
ii. Prenatal and postnatal sensitivity. There is no evidence of quantitative or qualitative enhanced susceptibility to infants and children. In the rat, developmental effects occur only at doses that cause mortality in the dams. The Maternal LOAEL of 740 mg ai/kg/day is based on mortality. The Maternal NOAEL is 221 mg ai/kg/day. The Developmental LOAEL of 740 mg ai/kg/day is based on increased gestation day (GD) 20 fetal death and a possible increase in minor skeletal anomalies. The Developmental NOAEL is 221 mg ai/kg/day.
In the rabbit, developmental effects occur only at doses where there is maternal toxicity. It was felt by the Hazard Identification Assessment Review Committee (HIARC) that the post implantation loss is actually due to the increased abortions in the does. The Maternal LOAEL of 300 mg ai/kg/day is based on decreased body weight gains for GD 6-18 and possible increased abortions. The Maternal NOAEL is 150 mg ai/kg/day. The Developmental LOAEL of 300 mg ai/kg/day is based on increased post-implantation loss. The Developmental NOAEL is 150 mg ai/kg/day.
In the reproduction toxicity study, offspring effects only occurred at levels resulting in maternal toxicity. The LOAEL for systemic/parental toxicity is 8000 ppm based on decreased body weights of F0 and F1 adults. The systemic/parental toxicity NOAEL is 1250 ppm.
iii. Conclusion. There is a complete toxicity data base for propyl[3-(dimethylamino)propyl]carbamate Start Printed Page 58396monohydrochloride and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. EPA determined that the 10X safety factor to protect infants and children should be removed. The FQPA factor is removed because the prenatal and postnatal toxicology database is complete and there is no indication of increased susceptibility. A developmental neurotoxicity study is not required. The dietary (food and drinking water) exposure assessments will not underestimate the potential exposures for infants and children from the use of propamocarb hydrochloride.
E. 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 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 ground water are less than the calculated DWLOCs, the 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.
1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food to propyl[3-(dimethylamino)propyl]carbamate monohydrochloride will occupy 1 %% of the aPAD for the U.S. population, 1 %% of the aPAD for females 13 years and older, 3%% of the aPAD for all infants (< 1 year old) and 3 %% of the aPAD for children 1-6 years old. In addition, there is potential for acute dietary exposure to propyl[3-(dimethylamino)propyl]carbamate monohydrochloride 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 3:
|Population Subgroup||a PAD (mg/kg)||% aPAD (Food)||Surface Water EEC (ppb)||Ground Water EEC (ppb)||Acute DWLOC (ppb)|
|All infants < 1year old||2.0||3||1030||2.08||19000|
|Children 1-6 years old||2.0||3||1030||2.08||19000|
|Females 13-50 years old||1.5||1||1030||2.08||45000|
|General U.S. population||2.0||1||1030||2.08||69000|
2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to propyl[3-(dimethylamino)propyl]carbamate monohydrochloride from food will utilize 7%% of the cPAD for the U.S. population, 9%% of the cPAD for all infants < 1 year old and 23 %% of the cPAD for children 1-6 years old. It has been assumed that there are no residential uses for propyl[3-(dimethylamino)propyl]carbamate monohydrochloride that result in chronic residential exposure to propyl[3-(dimethylamino)propyl]carbamate monohydrochloride, as shown in the following Table 4:
|Population Subgroup||cPAD mg/kg/day||% cPAD (Food)||Surface Water EEC (ppb)||Ground Water EEC (ppb)||Chronic DWLOC (ppb)|
|Infants < 1 year old||0.12||9||340||2.08||1100|
|Children 1-6 years old||0.12||23||340||2.08||920|
|Females 13-50 years old||0.12||5||340||2.08||3400|
3. 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).
Propyl[3-(dimethylamino)propyl]carbamate monohydrochloride 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 propyl[3-(dimethylamino)propyl]carbamate monohydrochloride.
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 950, 1100 and 1100 for females 13-50 years old, males 13-19 years old and the general U.S. population, respectively. The short-term aggregate risk assessment estimates risks likely to result from 1-7 day exposure to propamocarb hydrochloride residues in food, drinking water, and residential pesticide uses. High-end estimates of the residential exposure are used in the short-term assessment. Average values are used for food and drinking water exposure.
For short-term aggregate exposure risk, the oral and dermal exposures can be combined since both are based on the same toxicity endpoint (decreased body weight). An MOE of 100 is adequate to ensure protection from propamocarb hydrochloride via the dermal route for residential exposures.
According to the 1995 RED for propamocarb hydrochloride (Estimated Usage of Pesticide, p. 3), “almost all usage of propamocarb hydrochloride in the United States is concentrated on golf courses with approximately 100,000 to 200,000 lbs ai applied per year”. The label for Banol states that only protected handlers may be present in the treated area during application. For these reasons, it is assumed that this product will be used by commercial applicators, mainly on golf courses. The high-end scenario for residential post-application exposure is the golf course use of Banol. Therefore, in aggregating short-term risk, the Agency considered background chronic dietary exposure (food and drinking water) and short-term golfer dermal exposure. 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 propyl[3-(dimethylamino)propyl]carbamate monohydrochloride 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 concern, as shown in the following Table 5:
|Population Subgroup||Aggregate MOE (Food + Residential)||Aggregate Level of Concern (LOC)||Surface Water EEC (ppb)||Ground Water EEC (ppb)||Short-Term DWLOC (ppb)|
|Females 13-50 years old||950||100||1030||2.08||40000|
|Males 13-19 years old||1100||100||1030||2.08||63000|
|General U.S. Population||1100||100||1030||2.08||63000|
4. 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). The short-term aggregate assessment adequately addresses both the short- and intermediate-term golfer dermal exposures. The short and intermediate-term dermal endpoints were chosen from the 21-day dermal rabbit toxicity study. The short-term golfer exposure was calculated assuming 1-7 day exposure to propamocarb hydrochloride. The intermediate-term aggregate risk assessment estimates risks likely to result from 7 days to 3 months exposure. In the event of intermediate-term exposure, propamocarb hydrochloride residues are expected to dissipate over time. Therefore, the short-term aggregate assessment is expected to present a high-end conservative estimate of intermediate-term risk. As the short-term aggregate risk assessment represents the high-end scenario, an intermediate-term assessment was not performed.
5. Aggregate cancer risk for U.S. population. An aggregate cancer risk analysis was not performed since there is no concern for mutagenic potential and there is no evidence of carcinogenic potential in either the rat or mouse. Propamocarb has been classified as “not likely to be carcinogenic in humans”.
6. 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 propyl[3-(dimethylamino)propyl]carbamate monohydrochloride residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
The petitioner utilized a gas chromatography method for the determination of propamocarb hydrochloride residues in/on raw agricultural commodity samples collected from the potato field study and field rotational crop study. The reported limit of quantitation was 0.05 ppm. The method validation and concurrent method recovery data indicate that this method is adequate for data collection.
An identical method is proposed for tolerance assessment. The proposed method has undergone a successful independent lab validation and petition validation method. EPA concludes that the requirements for a plant enforcement method have been fulfilled for the purpose of this petition.
A ruminant feeding study is required. Conclusions about the need for livestock tolerances and appropriate enforcement analytical method are deferred until receipt of the ruminant feeding study and determination of the residues of concern in livestock.
B. International Residue Limits
No Codex limit has been established for propamocarb hydrochloride in/on the raw agricultural commodity (RAC) potato or its processed commodities, or animal (except poultry) commodities of meat, meat byproducts, or milk. Canadian and Mexican maximum residue limits (MRLs) have been established for the use on the RAC potato at 0.5 ppm. Harmonization is not possible because the submitted crop Start Printed Page 58398field data support the establishment of a tolerance on potatoes at 0.06 ppm. Canadian tolerances were established based, in part, on field studies from Europe where, in at least one test, dosages higher than those proposed in the U.S. were applied more frequently and closer to harvest.
The conditions of registration will include submission of a livestock feeding study (which determines the metabolites N-oxide propamocarb, 2-hydroxy propamocarb and oxazolidine) and storage stability data from the livestock feeding study. The need for a livestock analytical enforcement method and livestock tolerances will be determined after receipt of the ruminant feeding study and determination of the residues of concern in livestock. A corrosion characteristics study must be submitted as soon as completed.
Therefore, the tolerance is established for residues of propyl[3-(dimethylamino)propyl]carbamate monohydrochloride, known as propamocarb hydrochloride, in or on potatoes at 0.06 ppm.
VI. 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.
A. 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-301057 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 28, 2000.
1. 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.
2. 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 email@example.com, 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.
3. 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-301057, 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: firstname.lastname@example.org. 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 file format 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.
B. 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).
VII. 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). 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 Start Printed Page 58399Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any prior consultation as specified by Executive Order 13084, entitled Consultation and Coordination with Indian Tribal Governments (63 FR 27655, May 19, 1998); special considerations as required by Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or require OMB review or any 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 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).
VIII. 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).Start List of Subjects
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 21, 2000.
Susan B. Hazen,
Acting Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:End Amendment Part Start Part
PART 180— [AMENDED]End Part Start Amendment Part
1. The authority citation for part 180 continues to read as follows:End Amendment Part Start Amendment Part
2. Section 180.499 is amended by adding text to paragraph (a) to read as follows:End Amendment Part
(a) General. Tolerances are established for the residues of propyl[3-(dimethylamino)propyl]carbamate monohydrochloride also known as propamocarb hydrochloride in or on the following raw agricultural commodity:
|Commodity||Parts per million|
[FR Doc. 00-25049 Filed 9-28-00; 8:45 am]
BILLING CODE 6560-50-S