Environmental Protection Agency (EPA).
This regulation establishes tolerances for residues of glyphosate in or on various food commodities. Start Printed Page 57958Monsanto Company and the Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality Protection Act of 1996.
This regulation is effective September 27, 2000. Objections and requests for hearings, identified by docket control number OPP-301053, must be received by EPA on or before November 27, 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-301053 in the subject line on the first page of your response.Start Further Info
FOR FURTHER INFORMATION CONTACT
By mail: Hoyt Jamerson, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460; telephone number: 703-308-9368; and e-mail address: firstname.lastname@example.org.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||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 Documents.” 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-301053. 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 January 10, 2000 and July 25, 2000 (65 FR 1370) (FRL-6394-6) and (65 FR 45769) (FRL-6596-4),respectively, EPA issued notices 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 pesticide petitions (PP) for tolerance by Monsanto Company, 600 13th Street NW., Suite 660, Washington DC 20005. In addition, in the Federal Register of August 14, 2000 (65 FR 49563) (FRL-6739-2), 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 pesticide petition (PP) for tolerance by IR-4, Technology Center of New Jersey, 681 U.S. Highway #1 South, North Brunswick, NJ 08902-3390. These notices included a summary of the petitions prepared by Monsanto Company. Comments were received from Monsanto in response to the notice of filing. Monsanto noted that the tolerance proposal for the leafy vegetable group is for residues of glyphosate at 0.2 ppm, not 2.0 ppm, and that there is no proposal for residues of glyphosate in or on poultry meat. The Agency agrees that the appropriate tolerance level for the leafy vegetable group is 0.2 ppm. Monsanto has agreed that a tolerance for poultry meat at 0.1 ppm is needed to harmonize with CODEX. There were no other comments received in response to the notices of filing.
The petitions requested that 40 CFR 180.364 be amended by establishing tolerances for residues of glyphosate, (N-(phosphonomethyl)glycine) resulting from the application of glyphosate, the isopropylamine salt of glyphosate, the ethanolamine salt of glyphosate, and the ammonium salt of glyphosate in or on alfalfa hay at 400 ppm; grass, forage, fodder and hay group; nongrass animal feed group, kenaf forage, and leucaena forage at 200 ppm; alfalfa forage at 175 ppm; cereal grain group (except barley, field corn, grain sorghum, oats and wheat) at 100 ppm; rapeseed meal at 15, rapeseed seed at 10 ppm, flax meal at 8.0 ppm; dried hops cones, and spices subgroup at 7.0 ppm; teff grain at 5.0 ppm, flax seed at 4.0 ppm; field corn forage at 3.0 ppm; dokudami at 2.0 ppm, and Mexican oregano leaves at 2.0; perilla tops at 1.8 ppm; epazote at 1.3 ppm; betelnut. chaya, pine nut, and stevia dried leaves at 1.0 ppm; aloe vera, cactus fruit, cactus pads, okra, ugli fruit, and quinoa grain at 0.5 ppm; ambarella, globe artichoke, bambo shoots, berry group, biriba, blimbe, custard apple, feijoa, galangal roots, ginger white flower, governor's plum, gow kee leaves, herbs subgroup, ilama, imbe, imbu, juneberry, kava roots, lingonberry, mamey apple, mioga flower, palm heart, palm heart leaves, mountain papaya, pawpaw, pepper leaf (fresh leaves), pulasan, rose apple, salal, Spanish lime, star apple, strawberry, surinam cherry, ti leaves, ti roots, Brassica leafy vegetable, foliage of legume vegetable group (except soybean forage and hay), leafy vegetable group, leaves of root and tuber vegetable group (except sugar beet Start Printed Page 57959tops), root and tuber vegetable group (except sugar beet), wasabi root, water spinach tops, upland watercress, and wax jambu at 0.2; borage seed, crambe seed, buffalo gourd seed, egg, jojoba seed, lesquerella seed, meadowfoam seed, mustard seed, poultry meat, safflower seed, and sesame seed at 0.1 ppm.
In addition to the commodity tolerances proposed by IR-4 and Monsanto, Monsanto proposed to amend 40 CFR part 180 by revising the tolerance expression under § 180.364(a)(1) to read as follows:
§ 180.364 Glyphosate; tolerances for residues. (a)(1) General. Tolerances are established for residues of glyphosate (N-(phosphonomethyl)glycine) from the application of glyphosate, the ethanolamine salt of glyphosate, and the ammonium salt of glyphosate .... ”
Monsanto also proposed that the existing text in § 180.364(a)(1) by redesignated as § 180.364(a), that the tolerances in §§ 180.364(a)(2) and (a)(3) be transferred to the table in newly designated § 180.364(a), and that the introductory text of § 180.364(a)(2) and (a)(3) be deleted. Additional revisions to the table in § 180.364(a) are the deletion of duplicate commodity tolerance entries and the deletion of commodity tolerances that are superceded by the proposed crop group tolerances and the conversion of commodity terms to comply with EPA's Food and Feed Vocabulary Data Base (http://www.epa.gov/pesticides/foodfeed/). The Agency is also deleting all commodity entries under § 180.364(d)—indirect or inadvertent residues since these commodities will have tolerance established at the same or higher levels in the newly established § 180.364(a).
IR-4 proposed a tolerance for residues of glyphosate in or on the grass, forage, fodder and hay group at 200 ppm. IR-4's proposal is based on data previously reviewed by EPA in support of established tolerances for bahiagrass, bluegrass, bermudagrass, fescue, orchardgrass, ryegrass, timothy, and wheatgrass at 200 ppm. Monsanto has also proposed a grass, forage, fodder and hay tolerance; however, Monsanto has requested a tolerance level of 300 ppm. Monsanto's tolerance proposal for the grass group is based on new residue data which reflect changed use patterns and pre-grazing intervals for the grasses. In the notice filings cited above, reference was made to the 300 ppm tolerance level but not the 200 ppm level. Because the Agency has determined that the available data are adequate to support IR-4's tolerance proposal for residues of glyphosate in or on the grass, forage, fodder and hay group at 200 ppm and EPA has not completed review of Monsanto's new data supporting the 300 ppm level, EPA is establishing the tolerance for grass, forage, fodder and hay at 200 ppm. The Agency will reevaluate the grass group tolerance based on the residue data submitted by Monsanto and will make a decision on the proposed grass group tolerance at 300 ppm at a later date.
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 these tolerances for residues of glyphosate. EPA's assessment of exposures and risks associated with establishing the tolerances 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 glyphosate 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 rats||NOAEL less than 50 milligrams (mg)/kilogram (kg)/day for both sexes|
|LOAEL = 50 mg/kg/day based on increased phosphorus and potassium in both sexes|
|870.3100||90-Day oral toxicity in mice||NOAEL = 1,500 mg/kg/day in both sexes|
|LOAEL = 7,500 mg/kg/day in both sexes based on decreased body weight gain in both sexes.|
|870.3200||21/28-Day dermal toxicity in rabbits||NOAEL = 1,000 mg/kg/day for males and 5,000 mg/kg/day for females|
|LOAEL = 5,000 mg/kg/day in males based on decreased food consumption|
|870.3700a||Prenatal developmental toxicity in rats||Maternal NOAEL = 1,000 mg/kg/day|
|LOAEL = 3,500 mg/kg/day based on mortality, increased clinical signs, and reduced body weight gain|
|Start Printed Page 57960|
|Developmental NOAEL = 1,000 mg/kg/day|
|LOAEL = 3,500 mg/kg/day based on decreases in total implantations/dam and nonviable fetuses/dam, increased number of litters and fetuses with unossified sternebrae, and decreased fetal body weight|
|870.3700b||Prenatal developmental toxicity in rabbits||Maternal NOAEL = 175 mg/kg/day|
|LOAEL = 350 mg /kg/day based on mortality, and clinical signs|
|Developmental NOAEL = 175 mg/kg/day|
|LOAEL = 350 mg/kg/day (insufficient litters available to assess developmental toxicity)|
|870.3800||Reproduction and fertility effects in rats||Parental/Systemic NOAEL = 500 mg/kg/day for males and females|
|LOAEL = 1,500 mg/kg/day for males and females based on clinical signs, decreased body weights, decreased weight gain, and decreased food consumption in both sexes|
|Reproductive/Offspring NOAEL = 500 mg/kg/day for males and females|
|LOAEL = 1500 mg/kg/day for males and females based on reduced pup weights in both sexes during second and third weeks of lactation|
|870.4100b||Chronic toxicity in dogs||NOAEL = 500 mg/kg/day (highest dose tested)|
|LOAEL greater than 500 mg/kg/day|
|870.4300||Combined Chronic Toxicity/ Carcinogenicity in rats||NOAEL = 362 mg/kg/day in males and 457 mg/kg/day in females|
|LOAEL = 940 mg/kg/day in males and 1,183 mg/kg/day in females based on decreased weight gain in females, and increased incidence of cataracts and lens abnormalities, decreased urinary pH, increased absolute liver weight, and increased relative liver weight/brain weight in males. There was no evidence of carcinogenicity.|
|870.4200b||Carcinogenicity in mice||NOAEL = 750 mg/kg/day in males and females|
|LOAEL = 4,500 mg/kg/day in both sexes based on decreased body weight gains in both sexes, increased incidence of renal proximal tubule epithelial basophilia and hypertrophy in females and increased incidence of interstitial nephritis, hepatocellular hypertrophy and hepatocellular necrosis in males There was no evidence of carcinogenicity.|
|870.5100||In vitro rec-assay with B. subtilis H17 (rec+) and M45 (rec-) and reverse mutation assay using E. coli WP2 hcr and S. typhimurium strains||There was no evidence of genotoxicity up to the limit dose or cytotoxicity in the presence or absence of metabolic activation.|
|870.5265||In vitro reverse gene mutation assay in S. typhimurium bacteria||There was no evidence of induced mutant colonies over background in Salmonella strains TA 98, TA 100, TA 1535, and TA 1537 both in the presence and absence of metabolic activation at doses up to cytoxic levels or the limit dose.|
|870.5300||In vitro gene mutation assay in Chinese hamster ovary cells/HGPRT||There was no evidence of genotoxicity up to cytotoxic levels in the presence and absence of metabolic activation.|
|870.5385||Bone marrow chromosome aberrations assay||There was no significant increase in the frequency of chromosome aberrations in bone marrow at the limit dose of 1,000 mg/kg in both sexes of Sprague-Dawley rats.|
|870.7485||Metabolism in rats||Following a single oral dose, 30-36% was absorbed and less than 0.27% was eliminated as CO2. Urine and feces contained 97.5% as parent. Aminomethylphosphonic acid (AMPA) was only metabolite found at 0.2-0.3% of administered dose. Less than 1.0% of the absorbed dose remained in tissues and organs, primarily in the bone.|
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 lowest dose at which adverse effects of concern are identified (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 Start Printed Page 57961interspecies 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 × 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 glyphosate used for human risk assessment is shown in the following Table 2:
|Exposure Scenario||Dose Used in Risk Assessment, UF||FQPA SF* and Level of Concern for Risk Assessment||Study and Toxicological Effects|
|Acute Dietary||None||Not applicable||There were no effects that could be attributed to a single exposure (dose) in oral toxicity studies including the developmental toxicity studies in rats and rabbits.|
|Chronic Dietary all populations||NOAEL = 175 mg/kg/day; UF = 100; Chronic RfD = 2.0 mg/kg/day||FQPA SF = 1X; cPAD = chronic RfD ÷ FQPA SF = 2.0 mg/kg/day||Developmental toxicity in rabbits Maternal LOAEL = 350 mg/kg/day based on diarrhea, nasal discharge and mortality Developmental toxicity was not observed at any dose tested.|
|Short-, Intermediate-, and Long-Term Dermal (Residential)||None||Not applicable.||No systemic toxic effects were seen at doses up to 1,000 mg/kg/day in the 21-day dermal toxicity study.|
|Inhalation (any time period) (Residential)||None||Not applicable.||Based on low toxicity of formulations and technical material wet cake inhalation study was waived.|
|Cancer (oral, dermal, inhalation)||Group E||Not applicable||There is no evidence of carcinogenic potential.|
|* 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. Tolerances have been established (40 CFR 180.364) for the residues of glyphosate, in or on a variety of food commodities. Tolerances are established for cattle, hog, horse and sheep kidney at 4.0 ppm and liver at 0.5 ppm. Tolerance levels for residues of glyphosate at 0.1 ppm for egg and poultry meat and 1.0 ppm for poultry meat byproducts were proposed by IR-4. Risk assessments were conducted by EPA to assess dietary exposures from glyphosate 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 1-day or single exposure. An acute dietary endpoint and dose was not identified for glyphosate. A review of the rat and rabbit developmental studies did not provide a dose or endpoint that could be used for acute dietary risk purposes. Additionally, there were no data requirements for acute or subchronic rat neurotoxicity studies since there was no evidence of neurotoxicity in any of the toxicology studies at very high doses and glyphosate lacks a leaving group.
ii. Chronic exposure. In conducting this chronic dietary risk assessment 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 chronic exposure assessments: The chronic dietary exposure analysis from food sources was conducted using the reference dose (RfD) of 2.0 mg/kg/day. The RfD is based on the maternal NOAEL of 175 mg/kg/day from a rabbit developmental study and an uncertainty factor of 100 (applicable to all population subgroups). The DEEM® analysis assumed tolerance level residues and 100% crop treated in/on all commodities with an existing or proposed glyphosate tolerance.
iii. Cancer. There is no evidence of carcinogenic potential.
2. Dietary exposure from drinking water. The available field and laboratory data indicate that glyphosate adsorbs strongly to soil and would not be expected to move vertically below the 6 inch soil layer. Based on unaged batch equilibrium studies glyphosate and glyphosate residues are expected to be immobile with Kd(ads) values ranging from 62 to 175. The mechanism of adsorption is unclear; however, it is Start Printed Page 57962speculated that it may be associated with vacant phosphate sorption sites or high levels of metallic soil cations. The data indicate that chemical and photochemical decomposition is not a significant pathway of degradation of glyphosate in soil and water. However, glyphosate is readily degraded by soil microbes to AMPA, which is degraded to CO2, although at a slower rate than parent glyphosate.
The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for glyphosate 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 glyphosate.
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 the Screening Concentration in Ground Water model (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 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 glyphosate they are further discussed in the aggregate risk sections below.
Using available environmental fate parameters and assuming two applications with a retreatment interval of 90 days at a rate of 5 lbs ai/A (3.75 lbs ai/A), the ground water EEC from glyphosate using SCI-GROW was 0.0038 parts per billion (ppb). The current label allows multiple applications of 0.37 - 5 lbs ai/A up to a maximum of 10.6 lbs ai/A/year. The ground water EECs generated by SCI-GROW are based on the largest 90-day average recorded during the sampling period. Since there is relatively little temporal variation in ground water concentrations compared to surface water, the concentrations can be considered as acute and chronic values.
The GENEEC model was used to estimate surface water concentrations for glyphosate resulting from its maximum use rate on crops. GENEEC is a single event model (one runoff event), but can account for spray drift from multiple applications. GENEEC represents a 10 hectare field immediately adjacent to a 1 hectare pond that is 2 meters deep with no outlet. The pond receives a spray drift event from each application plus one runoff event. The runoff event moves a maximum of 10% of the applied pesticide into the pond. This amount can be reduced due to degradation on the field and by soil sorption. Spray drift is estimated at 5% of the application rate. The GENEEC values represent upper- bound estimates of the concentrations that might be found in surface water due to glyphosate use. Thus, the GENEEC model predicts that glyphosate surface water EECs range from a peak of 21 ppb to a 56-day average of 2.5 ppb. For comparison purposes, EPA guidance suggests dividing the 56-day GENEEC EEC value by 3 before comparison to the calculated DWLOCchronic value “Interim Guidance for Incorporating Drinking Water Exposure into Aggregate Risk Assessments,” 01-AUG-1999 (SOP 99.5). Thus, 2.5 divided by 3 or 0.83 ppb is the predicted surface water EEC value resulting from glyphosate treatment of crops.
To estimate the possible concentration of glyphosate in surface water resulting from direct application to water, EPA assumed application to a water body 6 feet deep. At an application rate of 3.75 lb ai/A, the estimated concentration is 230 ppb. Because the glyphosate water-application estimate is greater than the crop-application estimate, 230 ppb is the appropriate value to compare to the calculated DWLOCchronic value for aggregate risk considerations.
Based on the GENEEC and SCI-GROW models the EECs of glyphosate for chronic exposures are estimated to be 230 ppb for surface water and 0.004 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).
Glyphosate is currently registered for use on the following residential non-dietary sites: ornamentals, greenhouses, residential areas, lawns, and industrial rights of way. Glyphosate is formulated in liquid and solid forms and it is applied using ground or aerial equipment. Based on the low acute toxicity and the lack of other toxicological concerns, exposures from residential uses of glyphosate are not expected to pose undue risks.
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 glyphosate 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, glyphosate 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 glyphosate 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). Start Printed Page 57963
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 increased susceptibility in rats and rabbits to in utero and/or postnatal exposure to glyphosate.
iii. Conclusion. There is a complete toxicity data base for glyphosate 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 toxicology data base is complete
- There is no indication of increased susceptibility of rats or rabbits to in utero and/or postnatal exposure to glyphosate (in the prenatal developmental toxicity study in rats, effects in the offspring were observed only at or above treatment levels which resulted in evidence of appreciable parental toxicity)
- The use of generally high quality data, conservative models and/or assumptions in the exposure assessment provide adequate protection of infants and children.
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 groundwater are less than the calculated DWLOCs, 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. No appropriate toxicological endpoint for a single dose exposure was identified in oral toxicity studies with glyphosate. Therefore, an acute RfD was not established, and there is no expectation of acute dietary risk from food and water.
2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to glyphosate from food will utilize 1.5% of the cPAD for the U.S. population, 3.1% of the cPAD for all infants less than 1 year old and 3.2% of the cPAD for children (1 to 6 years old). Based on the use pattern, chronic residential exposure to residues of glyphosate is not expected. In addition, there is potential for chronic dietary exposure to glyphosate 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:
|Population Subgroup||cPAD mg/kg/day||% cPAD (Food)||Surface Water EEC (ppb)||Ground Water EEC (ppb)||Chronic DWLOC (ppb)|
|All infants, less than 1 year old||2.0||3.1||230||0.004||19,000|
|Children, 1-6 years old||2.0||3.2||230||0.004||19,000|
3. Short- and intermediate-term risk. Short- and intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Though residential exposure could occur with the use of glyphosate, no toxicological effects have been identified for short- or intermediate-term toxicity. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's level of concern.
4. Aggregate cancer risk for U.S. population. Glyphosate is not expected to pose a cancer risk to humans.
5. 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 glyphosate residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methods are available for analysis of residues of glyphosate in or on plant and livestock commodities. These methods include gas-liquid chromatography (GLC) (Method I in Pesticides Analytical Start Printed Page 57964Manual (PAM) II; the limit of detection is 0.05 ppm) and high-pressure liquid chromatography (HPLC) with fluorometric detection. Use of the GLC method is discouraged due to the lengthiness of the experimental procedure. The HPLC procedure has undergone successful Agency validation and was recommended for inclusion in PAM II. A gas chromatography/mass spectometry method for glyphosate in crops has also been validated by EPA's Analytical Chemistry Laboratory.
The unpublished methods may be requested from: Calvin Furlow, PRRIB, IRSD (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460; telephone number: (703) 305-5229; e-mail address: email@example.com.
B. International Residue Limits
Several maximum residue limits (MRLs) for glyphosate (including AMPA) have been established by CODEX in or on various commodities. Based on toxicological considerations, EPA has determined that AMPA no longer needs to be regulated and with this regulation has deleted AMPA from the tolerance expression. Thus, harmonization with the MRLs for AMPA is not possible. The existing and recommended “rape, seed” tolerance of 10 ppm is already in harmony with the CODEX MRL. The recommended “corn, forage” tolerance of 3.0 ppm is based on crop field trial data obtained when using a new strain of Roundup Ready corn and thus cannot be lowered to achieve harmonization with the CODEX MRL of 1.0 ppm for “maize, forage.” There is no conflict between the CODEX MRL of 0.1 ppm for “poultry, meat” and the recommended U.S. tolerance of 1.0 ppm for “poultry, meat byproducts” as these commodities are not the same. Finally, although the available data support a tolerance of 0.05 ppm for egg, for harmonization purposes and because no risk issues are involved, a tolerance level of 0.1 ppm for “egg” is being established.
Therefore, tolerances are established for residues of glyphosate, (N-(phosphonomethyl)glycine) resulting from the application of glyphosate, the isopropylamine salt of glyphosate, the ethanolamine salt of glyphosate, and the ammonium salt of glyphosate, in or on the food commodities listed in this document.
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-301053 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 27, 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 firstname.lastname@example.org, 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-301053, 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: email@example.com. 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. Start Printed Page 57965
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 Title 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 12, 2000.
Director, Registration Division, 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 180.364 is amended by revising paragraph (a) and by removing and reserving paragraph (d), to read as follows:End Amendment Part
(a) General. Tolerances are established for residues of glyphosate (N-(phosphonomethyl)glycine) resulting from the application of glyphosate, the isopropylamine salt of glyphosate, the ethanolamine salt of glyphosate and the ammonium salt of glyphosate in or on the following food commodities:
|Commodity||Parts per million|
|Animal feed, nongrass group (except alfalfa)||200|
|Aspirated grain fractions||200|
|Beet, sugar, dried pulp||25|
|Beet, sugar, roots||10|
|Beet, sugar, tops||10|
|Citrus, dried pulp||1.5|
|Corn, field, forage||3.0|
|Corn, field, grain||1.0|
|Cotton, gin byproducts||100|
|Cotton, undelinted seed||15|
|Start Printed Page 57966|
|Fruit, citrus, group||0.5|
|Fruit, pome, group||0.2|
|Fruit, stone, group||0.2|
|Ginger, white, flower||0.2|
|Gourd, buffalo, seed||0.1|
|Gow kee, leaves||0.2|
|Grain, cereal, group (except barley, field corn, grain sorghum, oats and wheat)||0.1|
|Grain, cereal, stover and straw, group||100|
|Grass, forage, fodder and hay, group||200|
|Hop, dried cones||7.0|
|Nut, tree, group||1.0|
|Oregano, Mexican, leaves||2.0|
|Palm heart, leaves||0.2|
|Pepper leaf, fresh leaves||0.2|
|Poultry, meat byproduct||1.0|
|Sorghum, grain, grain||15|
|Soybean, aspirated grain fractions||50|
|Stevia, dried leaves||1.0|
|Vegetable, Brassica leafy, group||0.2|
|Vegetable, bulb, group||0.2|
|Vegetable, cucurbit, group||0.5|
|Vegetable, foliage of legume, group (except soybean forage and hay)||0.2|
|Vegetable, fruiting, group||0.1|
|Vegetable, leafy, group||0.2|
|Vegetable, leaves of root and tuber, group(except sugar beet tops)||0.2|
|Vegetable, legume, group (except soybean)||5.0|
|Vegetable, root and tuber, group (except sugar beet)||0.2|
|Water spinach, tops||0.2|
|Wheat, milling fractions (except flour)||20|
(d) Indirect or inadvertent residues. [Reserved]
FR Doc. 00-24318 Filed 9-26-00; 8:45 am
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