Source: http://federal.elaws.us/fr/6/22/2018/2018-13459
Timestamp: 2020-05-25 06:48:10
Document Index: 617105150

Matched Legal Cases: ['art 178', 'art 178', 'art 2', 'art 180', '§\u2009180', 'art 180', '§\u2009180']

2018-13459. Acetochlor; Pesticide Tolerances, Federal Register
Home » 2018 Issues » 83 FR (06/22/2018) » 2018-13459. Acetochlor; Pesticide Tolerances
This regulation establishes tolerances for residues of acetochlor in or on alfalfa and related animal commodities which are identified and discussed later in this document. Monsanto Company requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2017-0235, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/​dockets.
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2017-0235 in the subject line on the first page of your submission. All objections and requests for a hearing Start Printed Page 29024must be in writing, and must be received by the Hearing Clerk on or before August 21, 2018. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2017-0235, by one of the following methods:
In the Federal Register of February 27, 2018 (83 FR 8408) (FRL-9972-17), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 6F8533) by Monsanto Company, 1300 I Street NW, Suite 450 East, Washington, DC 20005. The petition requested that 40 CFR 180.470 (a) General., be amended by establishing tolerances for residues of the herbicide acetochlor,(2-chloro-2′-methyl-6′-ethyl-N-ethoxymethylacetanilide), and its metabolites containing either the 2-ethyl-6-methylaniline (EMA) or the 2-(1-hydroxyethyl)-6-methyl-aniline (HEMA) moiety, to be expressed as acetochlor equivalents, resulting from applications to soil or growing crops, in or on Alfalfa, forage at 8 parts per million (ppm), Alfalfa, hay at 20 ppm, Cattle, fat at 0.02 ppm, Cattle, kidney at 0.03 ppm, Cattle, meat at 0.02 ppm, Cattle, meat byproducts, except kidney at 0.02 ppm, Goat, fat at 0.02 ppm, Goat, kidney at 0.03 ppm, Goat, meat at 0.02 ppm, Goat, meat byproducts, except kidney at 0.02 ppm, Hog, kidney at 0.02 ppm, Horse, fat at 0.02 ppm, Horse, kidney at 0.03 ppm, Horse, meat at 0.02 ppm, Horse, meat byproducts, except kidney at 0.02 ppm, Milk at 0.02 ppm, Sheep, fat at 0.02 ppm, Sheep, kidney at 0.03 ppm, Sheep, meat at 0.02 ppm, Sheep, meat byproducts, except kidney at 0.02 ppm, and to amend 40 CFR part 180.470 (d) Indirect or inadvertent residues., by adding alfalfa as an exception in the description of the commodities as follows: Animal feed, nongrass, group 18, except alfalfa, forage, and Animal feed, nongrass, group 18, except alfalfa, hay. That document referenced a summary of the petition prepared by Monsanto Company, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.
Based upon review of the data supporting the petition, EPA has revised the proposed 8 ppm tolerance for alfalfa forage to 8.0 ppm. The reason for this change is explained in Unit IV.D.
Acetochlor has low acute toxicity by the oral, dermal, and inhalation routes of exposure and is minimally irritating to the eyes. A dermal irritation study indicates that it is a severe skin irritant. Acetochlor is also a strong dermal sensitizer. Evidence of neurotoxicity was observed in acute and subchronic neurotoxicity screening studies in rats, developmental toxicity studies in rats, and subchronic and chronic studies in dogs. In addition to the nervous system, the major target organs affected in subchronic and chronic studies in rats, dogs, and mice exposed to acetochlor are the liver, thyroid (secondary to liver), kidney, testes, and erythrocytes. Species-specific target organs include the nasal olfactory epithelium in rats and the lungs in mice.
There is no evidence of increased qualitative or quantitative susceptibility of fetuses or offspring to acetochlor exposure in the developmental and reproduction toxicity studies in rats and rabbits. In two developmental toxicity studies in rats, fetal effects (increased early resorptions, post-implantation loss, and decreased fetal weight) occurred at doses that also resulted in maternal toxicity (mortality, clinical signs of toxicity, and decreased maternal body weight). In two rabbit developmental toxicity studies, there were no adverse fetal effects at the highest doses tested (190 mg/kg/day and 300 mg/kg/day); whereas maternal toxicity (body weight loss) was seen at 190 mg/kg/day in one study. In three reproduction toxicity studies in rats, offspring effects (decreased pup weights in the first two studies; decreased pup weights, decreased F2 litter size at birth, and focal hyperplasia and polypoid adenomata in nasal epithelium of adult F1 offspring at study termination in the third study) occurred at the same or higher doses than those resulting in parental toxicity (decreased body weight or weight gain in the first two studies; focal hyperplasia and polypoid adenomata in nasal epithelium of adult F1 offspring at study termination in the third study). There was no evidence of reproductive toxicity observed at any Start Printed Page 29025dose tested in two of the three reproductive toxicity studies in rats. The third reproduction study in rats showed a decreased number of implantations at the highest dose tested of 216 mg/kg/day.
Because a clear mode of action was demonstrated for the rat tumors, EPA based the cancer classification on the data from the mouse. EPA classified acetochlor as “Suggestive Evidence of Carcinogenic Potential” based on weak evidence for benign lung tumors in male and female mice and histiocytic sarcomas in female mice, and determined that linear quantification of carcinogenic potential would not be appropriate for the mouse tumors. The rat nasal tumors, with a point of departure (POD) of 10 mg/kg/day, are the most sensitive effect for cancer risk. The chronic population adjusted dose (cPAD), based on the no observed adverse effect level (NOAEL) of 2.0 mg/kg/day from the chronic dog study, will be protective of both non-cancer and cancer effects, including rat nasal tumors, thyroid tumors, and mouse tumors.
Specific information on the studies received and the nature of the adverse effects caused by acetochlor as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document Acetochlor: Human Health Risk Assessment for Proposed New Use on Alfalfa and Related Animal Commodities at [insert page number] in docket ID number EPA-HQ-OPP-2017-0235.
A summary of the toxicological endpoints for acetochlor used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of January 22, 2014 (79 FR 3512) (FRL-9904-19).
Such effects were identified for acetochlor. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture's (USDA) National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in food, EPA assumed tolerance level residues except for livestock commodities where anticipated residues were used, and 100 percent crop treated (PCT) for all commodities.
ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA's NHANES/WWEIA. As to residue levels in food, anticipated residues from field trial data and livestock feeding studies were used, while 100% crop treated assumptions (including feed items) were made for all commodities.
iii. Cancer. Based on the results of carcinogenicity studies in rats and mice summarized in Unit III.A., EPA classified acetochlor as having “Suggestive Evidence of Carcinogenic Potential” but determined that the chronic risk assessment will be protective of both non-cancer and cancer effects. Therefore, a separate exposure assessment to evaluate cancer risk is unnecessary.
iv. Anticipated residue and percent crop treated (PCT) information. Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must require pursuant to FFDCA section 408(f)(1) that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such data call-ins as are Start Printed Page 29026required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submitted no later than 5 years from the date of issuance of these tolerances.
Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Pesticide Root Zone Model Ground Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of acetochlor for acute exposures are estimated to be 74.9 parts per billion (ppb) for surface water and 129 ppb for ground water. EDWCs for chronic exposures for non-cancer assessments are estimated to be 4.84 ppb for surface water and 82.6 ppb for ground water.
Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 129.0 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value of 82.6 ppb was used to assess the contribution to drinking water.
The chloroacetanilides have been evaluated by the Agency and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) as a related group of chemicals for this purpose. Acetochlor is included in a Cumulative Assessment Group of chloroacetanilide pesticides. For purposes of a cumulative risk assessment, it was determined that the common mechanism of toxicity group consists of alachlor, acetochlor, and butachlor. Butachlor is excluded from the group for risk assessment purposes at present because there are no registered uses or tolerances for this chemical in the U.S. The group was selected based on common endpoints of:
ii. Induction of hepatic uridine diphosphate-glucuronosyl transferase (UDPGT), which results in increased incidence of thyroid follicular cell tumors secondary to disruption of pituitary-thyroid homeostasis.
A cumulative risk assessment of the chloroacetanilide pesticides acetochlor and alachlor was conducted in April 2007 and did not identify any cumulative risks of concern. A revised quantitative cumulative assessment was not conducted because the proposed new use on alfalfa would not affect the cumulative risk results. The new use on alfalfa is not anticipated to affect the cumulative risk results for the following reasons: The major risk driver in the cumulative assessment was alachlor in drinking water, domestic alachlor uses are being phased out (tolerances are being maintained for imported foods), cumulative dietary exposure was not of concern when accounting for the contribution from alachlor, acetochlor is a very minor contributor to chloroacetanilide cumulative risk when compared to alachlor, and acetochlor is less toxic than alachlor. No further cumulative evaluation is necessary for acetochlor use on alfalfa.
2. Prenatal and postnatal sensitivity. No increase in susceptibility was seen in developmental toxicity studies in rats and rabbits or in three multi-generation reproductive toxicity studies in rats. Toxicity to offspring was observed at dose levels which were the same or greater than those causing maternal or parental toxicity. Based on the results of developmental and reproductive toxicity studies, there is no concern for increased qualitative and/or quantitative susceptibility of the young following exposure to acetochlor.
3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X for acute dietary, chronic dietary, and dermal. That decision is based on the following findings:
i. The toxicity database for acetochlor is complete for the purpose of evaluating this tolerance petition.
ii. Evidence of neurotoxicity from exposure to acetochlor was observed in several oral studies. However, these effects were typically observed at high doses. The points of departure selected for risk assessment are protective of the potential neurotoxicity observed in the database.
iii. There is no evidence that acetochlor results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction studies.
iv. There are no residual uncertainties identified in the exposure databases. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to acetochlor in drinking water. The acute dietary exposure analysis used tolerance level residues except for livestock commodities where anticipated residues were used and 100 PCT. The chronic dietary exposure analysis used anticipated residues from field trial data and livestock feeding studies, while 100% crop treated assumptions (including feed items) were made for all commodities and 100 PCT. These assessments will not underestimate the exposure and risks posed by acetochlor.
EPA determines whether acute and chronic dietary pesticide exposures are Start Printed Page 29027safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.
1. Acute risk. In examining acute aggregate risk, the only pathway of exposure relevant to the acute time frame is dietary exposure. Therefore, the acute aggregate risk is comprised of exposures to acetochlor residues in food and drinking water and is equivalent to the acute dietary risk estimates. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to acetochlor will occupy 1.6% of the aPAD for infants <1-year old, the population group receiving the greatest exposure.
2. Chronic risk. In examining chronic aggregate risk, the only pathway of exposure relevant to the chronic time frame is dietary exposure. Therefore, the chronic aggregate risk is comprised of exposures to acetochlor residues in food and drinking water and is equivalent to the chronic dietary risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to acetochlor from food and water will utilize 26% of the cPAD for all infants (<1 year old), the population group receiving the greatest exposure. There are no residential uses for acetochlor.
3. Short- and intermediate-term aggregate risk. Short-term and intermediate-term aggregate exposure take into account short-term or intermediate-term residential exposure plus chronic exposure from food and water (considered to be a background exposure level). Acetochlor is not registered for any use patterns that would result in residential exposure. Therefore, the short-term or intermediate-term aggregate risk is the sum of the risk from exposure to acetochlor through food and water and will not be greater than the chronic aggregate risk.
4. Aggregate cancer risk for U.S. population. The Agency has concluded that assessments using a non-linear approach (e.g., a chronic RfD-based approach) will adequately protect for all chronic toxicity, including carcinogenicity that could result from exposure to acetochlor. Chronic aggregate risk estimates are below the Agency's level of concern; therefore, cancer risk is also below the Agency's level of concern.
An Enforcement Analytical Method is available to enforce the proposed tolerances. The method is a high performance liquid chromatography/oxidative coulometric electrochemical detector (HPLC/OCED) method and is listed as Method I in the Pesticide Analytical Manual (PAM) Vol. II (§ 180.470).
The Codex has not established a MRL for acetochlor on alfalfa commodities, but there are Codex MRLs established for livestock commodities at 0.02 ppm. The tolerances established in this rulemaking are harmonized with the Codex MRLs for livestock commodities, except for the U.S. kidney tolerances, which are being established at 0.03 ppm.
EPA has revised the 8 ppm tolerance for alfalfa forage to 8.0 ppm, in accordance with policy. No other revisions were needed.
Therefore, tolerances are established for residues of acetochlor, in or on Alfalfa, forage at 8.0 ppm, Alfalfa, hay at 20 ppm, Cattle, fat at 0.02 ppm, Cattle, kidney at 0.03 ppm, Cattle, meat at 0.02 ppm, Cattle, meat byproducts, except kidney at 0.02 ppm, Goat, fat at 0.02 ppm, Goat, kidney at 0.03 ppm, Goat, meat at 0.02 ppm, Goat, meat byproducts, except kidney at 0.02 ppm, Hog, kidney at 0.02 ppm, Horse, fat at 0.02 ppm, Horse, kidney at 0.03 ppm, Horse, meat at 0.02 ppm, Horse, meat byproducts, except kidney at 0.02 ppm, Milk at 0.02 ppm, Sheep, fat at 0.02 ppm, Sheep, kidney at 0.03 ppm, Sheep, meat at 0.02 ppm, Sheep, meat byproducts, except kidney at 0.02 ppm, and to amend 40 CFR part 180.470 (d) Indirect or inadvertent residues., by adding alfalfa as an exception in the description of the commodities as follows: Animal feed, nongrass, group 18, except alfalfa, forage, and Animal feed, nongrass, group 18, except alfalfa, hay.
This action directly regulates growers, food processors, food handlers, and food Start Printed Page 29028retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.).
2. In § 180.470,
i. Add alphabetically the entries “Alfalfa, forage”; “Alfalfa, hay”; “Cattle, fat”; “Cattle, kidney”; “Cattle, meat”; “Cattle, meat byproducts, except kidney”; “Goat, fat”; “Goat, kidney”; “Goat, meat”; “Goat, meat byproducts, except kidney”; “Hog, kidney”; “Horse, fat”; “Horse, kidney”; “Horse, meat”; “Horse, meat byproducts, except kidney”; “Milk”; “Sheep, fat”; “Sheep, kidney”; “Sheep, meat“; “Sheep, meat byproducts, except kidney”; to the table in paragraph (a) and
ii. Revise the commodities “Animal feed, nongrass, group 18, except alfalfa, forage”, and “Animal feed, nongrass, group 18, except alfalfa, hay” in the table in paragraph (d).
Alfalfa, forage 8.0
Cattle, kidney 0.03
Cattle, meat byproducts, except kidney 0.02
Goat, kidney 0.03
Goat, meat byproducts, except kidney 0.02
Hog, kidney 0.02
Horse, kidney 0.03
Horse, meat byproducts, except kidney 0.02
Sheep, kidney 0.03
Sheep, meat byproducts, except kidney 0.02
Animal feed, nongrass, group 18, except alfalfa, forage 1.3
Animal feed, nongrass, group 18, except alfalfa, hay 3.5
[FR Doc. 2018-13459 Filed 6-21-18; 8:45 am]
29023-29028 (6 pages)
EPA-HQ-OPP-2017-0235, FRL-9976-41
2018-13459.pdf
» Monsanto Company Notice of Filing Pesticide Petition No. 6F8533 Eestablishing Tolerances for Residues of acetochlor (2-chloro-2'-methyl-6'-ethyl-Nethoxymethylacetanilide) and its Metabolites in or on Various Agricultural Products
40 CFR 180.470