Source: https://www.federalregister.gov/documents/2017/04/10/2017-07131/acetamiprid-pesticide-tolerances-for-emergency-exemption
Timestamp: 2017-04-24 03:34:08
Document Index: 474669965

Matched Legal Cases: ['art 178', 'art 178', 'art 178', 'art 2', 'art1', 'art 180', 'art2', '§\u2009180', '§\u2009180']

:: Acetamiprid; Pesticide Tolerances for Emergency Exemption
Acetamiprid; Pesticide Tolerances for Emergency Exemption
A Rule by the Environmental Protection Agency on 04/10/2017
This regulation is effective April 10, 2017. Objections and requests for hearings must be received on or before June 9, 2017, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
82 FR 17146
17146-17151
EPA-HQ-OPP-2017-0005
FRL-9959-90
Human Health Risk Assessment Addressing Proposed Label...
Aggregate Human Health Risk Assessment for the Proposed FIFRA...
III. Emergency Exemption for Acetamiprid on Sugarcane and FFDCA Tolerances
https://www.federalregister.gov/d/2017-07131
04/07/2017 at 08:45 am.
This regulation establishes time-limited tolerances for residues of acetamiprid in or on sugarcane, cane and sugarcane, molasses. This action is associated with the issuance of a crisis exemption under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide on sugarcane. This regulation establishes maximum permissible levels for residues of acetamiprid in or on sugarcane, cane and sugarcane, molasses. The time-limited tolerances expire on December 31, 2019.
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2017-0005, 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 section 408(g) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 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-2017-0005 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before June 9, 2017. 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-Start Printed Page 171472017-0005, by one of the following methods:
Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/​dockets/​where-send-comments-epa-dockets.
EPA, on its own initiative, in accordance with FFDCA sections 408(e) and 408(l ) (6) of, 21 U.S.C. 346a(e) and 346a(l)(6), is establishing time-limited tolerances for residues of acetamiprid, (1 E)-N-[(6-chloro-3-pyridinyl)methyl]-N'-cyano-N-methylethanimidamide, in or on sugarcane, cane at 45 parts per million (ppm) and sugarcane, molasses at 600 ppm. These time-limited tolerances expire on December 31, 2019.
Section 408(l)(6) of FFDCA requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption issued under FIFRA section 18. Such tolerances can be established without providing notice or period for public comment. EPA does not intend for its actions on FIFRA section 18 related time-limited tolerances to set binding precedents for the application of FFDCA section 408 and the safety standard to other tolerances and exemptions. Section 408(e) of FFDCA allows EPA to establish a tolerance or an exemption from the requirement of a tolerance on its own initiative, i.e., without having received any petition from an outside party.
With EPA's concurrence, the Louisiana Department of Agriculture and Forestry (LDAF) declared a crisis on June 17, 2016 necessitating the use of acetamiprid to control the West Indian canefly on sugarcane. At that time, LDAF stated that substantial yield losses had likely already occurred in sugarcane, and the West Indian canefly populations were moving into other crops nearby, posing significant risk to these crops as well.
The state agency asserted that an emergency condition exists in accordance with the criteria for approval of an emergency exemption, and issued a crisis exemption under FIFRA section 18 to allow the use of acetamiprid on sugarcane for control of West Indian canefly in Louisiana. After having reviewed the submission, EPA concurred that an emergency condition exists.
As part of its evaluation of the emergency exemption application, EPA assessed the potential risks presented by residues of acetamiprid in or on sugarcane cane and sugarcane molasses. In doing so, EPA considered the safety standard in FFDCA section 408(b)(2), and EPA decided that the necessary tolerance under FFDCA section 408(l)(6) would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing these tolerances without notice and opportunity for public comment as provided in FFDCA section 408(l)(6). Although these time-limited tolerances expire on December 31, 2019, under FFDCA section 408(l)(5), residues of the pesticide not in excess of the amounts specified in the tolerances remaining in or on sugarcane cane and sugarcane molasses after that date will not be unlawful, provided the pesticide was applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by these time-limited tolerances at the time of that application. EPA will take action to revoke these time-limited tolerances earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.
Because these time-limited tolerances are being approved under emergency conditions, EPA has not made any decisions about whether acetamiprid meets FIFRA' s registration requirements for use on sugarcane, or whether permanent tolerances for this use would be appropriate. Under these circumstances, EPA does not believe that this time-limited tolerance decision serves as a basis for registration of acetamiprid by a State for special local needs under FIFRA section 24(c). Nor do these tolerances by themselves serve as the authority for persons in any State other than Louisiana to use this pesticide on the applicable crops under FIFRA section 18 absent the issuance of an emergency exemption applicable within that State. For additional information regarding the emergency exemption for acetamiprid, contact the Agency's Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT.
Consistent with the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure expected as a result of this emergency exemption request and the time-limited tolerances for residues of acetamiprid on sugarcane, cane at 45 ppm and sugarcane, molasses at 600 ppm. EPA's assessment of exposures and risks associated with establishing time-limited tolerances follows.
Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in Start Printed Page 17148evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see https://www.epa.gov/​pesticide-science-and-assessing-pesticide-risks.
The complete human health risk assessment for this action may be found at http://www.regulations.gov in the document “Acetamiprid. Aggregate Human Health Risk Assessment for the Proposed FIFRA Section 18 Specific Exemption Use of the Insecticide on Sugarcane in Louisiana” in the docket for ID number EPA-HQ-OPP-2017-0005. Additionally, a summary of the toxicological endpoints for acetamiprid used for human risk assessment is discussed in Unit III. of the final rule published in the Federal Register of November 6, 2015 (80 FR 68772) (FRL-9936-12).
1. Dietary exposure from food and feed uses. In evaluating dietary exposure to acetamiprid, EPA considered exposure under the time-limited tolerances established by this action as well as all existing acetamiprid tolerances in 40 CFR 180.578. EPA assessed dietary exposures from acetamiprid in food as follows:
i. Acute exposure. Acute effects were identified for acetamiprid. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 2003-2008 National Health and Nutrition Examination Survey; What We Eat in America (NHANES/WWEIA). As to residue levels in food, EPA assumed one hundred percent crop treated (PCT), and established and proposed tolerance level residues except as follows for sugarcane molasses. No residue data were available for sugarcane molasses, and residue data from sweet corn stover were used as a surrogate. The Agency determined it appropriate to translate corn stover data to sugarcane, and the use patterns and maximum application rates for sweet corn and sugarcane are similar. The residue level of 240 ppm acetamiprid in sugarcane molasses and sugarcane molasses baby food was used for dietary risk assessment, which is less than the recommended tolerance of 600 parts per million (ppm). The 240 ppm level is based on the highest average field trial acetamiprid residue level of 20 ppm in sweet corn stover, multiplied by the average molasses processing factor of 12X. The average processing factor was derived from molasses processing data for 9 other pesticides, and results in a residue estimate that is more representative of potential levels which could occur in these commodities.
ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA again used the food consumption data from the USDA's 2003-2008 NHANES/WWEIA. Residue levels in food were included as explained in Unit IV.B.1.i. of this document at tolerance-level residues for established and proposed tolerances and 240 ppm for sugarcane molasses and sugarcane molasses baby food. Additionally, 100 PCT was assumed.
iii. Cancer. Based on the data referenced in Unit IV.A., EPA has concluded that acetamiprid does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.
iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for acetamiprid. As detailed in the previous section, residues were estimated for sugarcane molasses and sugarcane molasses baby food based upon data for sweet corn and incorporating an appropriate processing factor derived from processing data for 9 other pesticides in sugarcane. Tolerance level residues were used for the remainder of the commodities and 100 PCT were assumed for all food commodities.
2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for acetamiprid in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of acetamiprid. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at https://www.epa.gov/​pesticide-science-and-assessing-pesticide-risks/​about-water-exposure-models-used-pesticide.
EPA used the Food Quality Protection Act Index Reservoir Screening Tool and the Provisional Cranberry Model to generate to generate surface water Estimated Drinking Water Concentrations (EDWCs) for use in the human health dietary risk assessment, while the Pesticide Root Zone Model for Groundwater was used to generate groundwater EDWCs. The EDWCs of acetamiprid for acute exposures were estimated at 88.3 parts per billion (ppb) for surface water and 49.7 ppb for ground water. For chronic exposures (non-cancer assessment) the EDWCs were estimated at 32.2 ppb for surface water and 45.0 ppb for ground water. To assess dietary exposure contribution from drinking water, the higher acute EDWC of 88.3 ppb was used for acute assessment and for chronic exposures, the higher EDWC of 45 ppb was used. These modeled EDWCs were directly entered into the dietary exposure model.
Residential exposures to acetamiprid could result from the currently registered uses of spot-on dog treatments, application to mattresses, and as crack and crevice treatments. For the dog spot-on products, EPA determined that short- and intermediate-term residential exposures may occur for residential (non-professional) applicators through dermal and inhalation routes; and short- intermediate- and long-term exposures may occur post-application for adults and children through dermal exposures, and also through incidental oral ingestion for children 1-2 years old. For the mattress, crack, and crevice treatments, short- and intermediate-term residential handler exposure may occur through dermal and inhalation routes; and short- and intermediate-term exposures may occur post application for adults and children through dermal and inhalation routes, and also through incidental oral ingestion for children 1-2 years old. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at: https://www.epa.gov/​pesticide-science-and-assessing-pesticide-risks/​standard-Start Printed Page 17149operating-procedures-residential-pesticide.
EPA has not found acetamiprid to share a common mechanism of toxicity with any other substances, and acetamiprid does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that acetamiprid does not have 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 EPA's Web site at https://www.epa.gov/​pesticide-science-and-assessing-pesticide-risks/​cumulative-assessment-risk-pesticides.
2. Prenatal and postnatal sensitivity. The pre- and post-natal toxicity databases for acetamiprid include developmental toxicity studies in the rat and rabbit, developmental neurotoxicity (DNT) study in rats and a 2-generation reproduction toxicity study in rats. There was no evidence of increased quantitative or qualitative susceptibility of rat or rabbit fetuses following in utero exposure to acetamiprid in the developmental toxicity studies. In the DNT and 2-generation reproduction studies there was no evidence of quantitative increased susceptibility observed However, there was evidence of increased qualitative susceptibility of rat pups seen in the studies. In the DNT study in rats, although both maternal and offspring effects were seen at the same dose level, offspring animals were more severely affected. Decreased pre-weaning survival, and decreased maximum auditory startle response were observed in the presence of limited maternal toxicity (body weight effects). In the 2-generation reproduction study, effects observed were a decrease in mean body weight, body weight gain, and food consumption in the parental animals, and significant reductions in body weights in pups (both generations). Also, reduction in litter size and viability and weaning indices were seen among the second generation of offspring, as well as significant delays in the age to attain vaginal opening and preputial separation. These offspring adverse effects were more severe than the parental effects.
i. The toxicity database for acetamiprid is complete.
ii. Although there was evidence of increased qualitative susceptibility of the young in the DNT and 2-generation reproduction studies in rats, there are clear NOAELs identified for the effects observed in the toxicity studies. Also, there was no evidence of increased quantitative or qualitative susceptibility of rat or rabbit fetuses in the developmental toxicity studies.
iii. Acetamiprid produced signs of neurotoxicity in the high dose groups in the acute and developmental neurotoxicity studies in rats and the subchronic toxicity study in mice. However, no neurotoxic findings were reported in the subchronic neurotoxicity study in rats. Additionally, there are clear NOAELs identified for the effects observed in the toxicity studies. The doses and endpoints selected for risk assessment are protective and account for all toxicological effects observed in the database, including neurotoxicity.
iv. There are no residual uncertainties identified in the exposure databases. EPA made conservative (protective) assumptions in exposure assessments (food, drinking water and residential) assessment, including the use of 100 PCT assumptions, tolerance-level residue values, and upper-bound estimates of potential exposure through drinking water. In addition, the residential exposure assessment was conducted such that residential exposure and risk will not be underestimated. The aggregate exposure and risk estimates considered are expected to over-estimate the actual exposure and risk anticipated, based on the current and proposed use patterns; no risk estimates of concern were identified. These assessments will not underestimate the exposure and risks posed by acetamiprid.
1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to acetamiprid will occupy 69% of the aPAD for children 1 to 2 years old, the population group receiving the greatest exposure. Typically, EPA does not consider residential exposures when assessing acute aggregate risk unless such exposures can be characterized as a series of single-day exposures. For acetamiprid, residential exposures are assessed as short- and intermediate-term exposures. Therefore, acute aggregate risk estimates for acetamiprid are equivalent to the acute dietary risk estimates which are not of concern.
2. Chronic risk. Using the exposure assumptions described in unit IV. for chronic exposure, EPA has concluded that chronic exposure to acetamiprid from food and water will utilize 62% of the cPAD for children 1 to 2 years old, the population group receiving the greatest exposure. Dietary exposure from food and water, considered to be a background exposure level, is included in aggregate exposures for all population groups. Based on the explanation in Unit IV.B.3., adult aggregate chronic exposures also include long-term post-application dermal exposure from contact with dogs following spot-on treatment. For children 1 to 2 years old, aggregate chronic exposures also include long-term post-application dermal and incidental oral exposures from contact with spot-on treated dogs. The chronic dietary exposure and post-application pet spot-on residential exposure were aggregated and compared to the long-term POD. Adult and children long-term aggregate MOEs were 390 and 100, Start Printed Page 17150respectively, and are above the level of concern of an MOE <100, indicating that risk estimates are not of concern. The chronic dietary exposure estimates are highly conservative, assuming tolerance-level residues for registered uses and 100 PCT for all commodities. Therefore, EPA also considers the aggregate MOEs to be conservative estimates.
3. Short- and Intermediate-term risk. Acetamiprid is currently registered for uses that could result in short/intermediate-term residential exposure. Short- (1 to 30 days) and intermediate-term (1-6 months) aggregate exposures take into account short- and intermediate-term residential exposures plus chronic exposure to food and water (considered to be a background exposure level). Toxicological endpoints and points of departure for assessing short- and intermediate-term risks (including oral, dermal, and inhalation routes of exposure) are identical for acetamiprid. Therefore, separate assessments were not conducted and one risk assessment addresses both of these durations. Using the exposure assumptions described in unit IV.B.3. for short/intermediate-term exposures, EPA has concluded the combined short/intermediate-term food, water, and residential exposures result in aggregate MOEs of 290 for adults and 110 for children. Because EPA's level of concern for acetamiprid is an MOE of <100, these MOEs do not indicate risks of concern.
4. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, acetamiprid is classified as “not likely to be carcinogenic to humans” and is therefore 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, or to infants and children, from aggregate exposure to acetamiprid residues.
Adequate enforcement methodologies are available to enforce the tolerance expression, including gas chromatography with electron capture detection (GC/ECD) for vegetables and non-citrus fruits, high performance liquid chromatography with ultraviolet detection (HPLC/UV) for citrus fruits only, and HPLC with tandem mass spectrometric detection (LC/MS/MS) for vegetables and non-citrus fruits.
The methods may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: residuemethods@epa.gov.
In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. The Codex has not established an MRL for acetamiprid on sugarcane.
Therefore, time-limited tolerances are established for residues of acetamiprid, (1 E)-N-[(6-chloro-3-pyridinyl)methyl]-N′-cyano-N-methylethanimidamide, in or on sugarcane, cane at 45 ppm and sugarcane, molasses at 600 ppm. These tolerances expire on December 31, 2019.
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA submitted 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 the rule in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).
Start Amendment Part1. The authority citation for part 180 continues to read as follows: End Amendment Part
Start Amendment Part2. In § 180.578, revise paragraph (b) to read as follows: End Amendment Part
§ 180.578 Acetamiprid; tolerances for residues.
(b) Section 18 emergency exemptions. Time-limited tolerances specified in the following table are established for residues of the acetamiprid, (1 E)-N-[(6-chloro-3-pyridinyl)methyl]-N'-cyano-N-methylethanimidamide, in or on the specified agricultural commodities, resulting from use of the pesticide pursuant to FIFRA section 18 emergency exemptions. Compliance with the tolerance levels specified below is to be determined by measuring only acetamiprid. The tolerances expire on the date specified in the table.
CommodityParts per millionExpiration dateSugarcane, cane4512/31/2019Sugarcane, molasses60012/31/2019
[FR Doc. 2017-07131 Filed 4-7-17; 8:45 am]