82 FR 17563 - Monoethanolamine; Exemption From the Requirement of a Tolerance
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 82, Issue 69 (April 12, 2017)
Federal Register Volume 82, Issue 69 (April 12, 2017)
| Page Range | 17563-17569 | |
| FR Document | 2017-07130 |
[Federal Register Volume 82, Number 69 (Wednesday, April 12, 2017)] [Rules and Regulations] [Pages 17563-17569] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-07130] [[Page 17563]] ======================================================================= ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2015-0697; FRL-9949-11] Monoethanolamine; Exemption From the Requirement of a Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This regulation establishes an exemption from the requirement of a tolerance for residues of monoethanolamine (CAS Reg. No. 141-43-5) when used as an inert ingredient (solvent) in pesticides applied to growing crops and raw agricultural commodities after harvest limited to a maximum concentration of 3.35% by weight in the pesticide formulation. Technology Sciences Group Inc., on behalf of Doosan Corporation, submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of monoethanolamine when used in accordance with the approved concentrations. DATES: This regulation is effective April 12, 2017. Objections and requests for hearings must be received on or before June 12, 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). ADDRESSES: The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2015-0697, 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. FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address: [email protected]. SUPPLEMENTARY INFORMATION: I. General Information A. Does this action apply to me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:Crop production (NAICS code 111). Animal production (NAICS code 112). Food manufacturing (NAICS code 311). Pesticide manufacturing (NAICS code 32532). B. How can I get electronic access to other related information? You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. C. How can I file an objection or hearing request? 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-2015-0697 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 12, 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-2015-0697, by one of the following methods: Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute. Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001. Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets. II. Petition for Exemption In the Federal Register of November 23, 2015 (80 FR 72941) (FRL- 9936-73), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP IN- 10839) by Technology Sciences Group Inc. (1150 18th Street NW., Suite 1000, Washington, DC 20036) on behalf of Doosan Corporation (864 B/5F, Aict, 864-1, lui-dong, Yeongtong-gu, Suwon-si, Gyeonggi-do, 443-284, Republic of Korea). The petition requested that 40 CFR 180.910 be amended by establishing an exemption from the requirement of a tolerance for residues of monoethanolamine (CAS Reg. No. 141-43-5) when used as an inert ingredient (solvent) in pesticide formulations applied to growing crops and raw agricultural commodities after harvest. That document referenced a summary of the petition prepared by Technology Sciences Group Inc. on behalf of Doosan Corporation, the petitioner, 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 limited the maximum concentration of monoethanolamine to 3.35% by weight in pesticide formulations. The reason for this change is explained in Unit V.B. below. III. Inert Ingredient Definition Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a [[Page 17564]] pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term ``inert'' is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients. IV. Aggregate Risk Assessment and Determination of Safety Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for 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) of FFDCA 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) of FFDCA 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 establishes exemptions from the requirement of a tolerance only in those cases where it can be clearly demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established. Consistent with FFDCA section 408(c)(2)(A), and the factors specified in FFDCA section 408(c)(2)(B), 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 for monoethanolamine including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with monoethanolamine follows. A. Toxicological Profile EPA has evaluated the available toxicity data and considered their 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. Specific information on the studies received and the nature of the adverse effects caused by monoethanolamine as well as the no- observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse- effect-level (LOAEL) from the toxicity studies are discussed in this unit. The acute oral and dermal toxicities are low in rats and rabbits for monoethanolamine. The lethal dose (LD 50 s) are >1,000 milligram/kilogram (mg/kg) in acute oral and dermal studies in the rat and rabbit, respectively. Monoethanolamine is irritating to the skin at 1%, very irritating at >1% and corrosive at 10% in the rabbit. It is corrosive to the eyes in rabbits. Acute inhalation toxicity is low; the LD50 is >1.3 milligram/liter. It is not a dermal sensitizer in the guinea pig maximization test or in the mouse local lymph node assay. Subchronic exposure to rats administered monoethanolamine via the diet causes increases liver and kidney weights at 640 mg/kg/day. The NOAEL is 320 mg/kg/day. Monoethanolamine did not cause developmental nor maternal effects up to 450 mg/kg/day, the highest dose tested, in a developmental toxicity study via gavage in rats. In developmental studies via dermal exposure, maternal toxicity (irritation, necrosis, scabbing and scar formation) is observed in rats at 225 mg/kg/day. Developmental toxicity in rats is not observed at 225 mg/kg/day, the highest dose tested. In rabbits, maternal toxicity (skin irritation, necrosis, scabbing and scar formation) and developmental toxicity (reduced body weight) are observed at 75 mg/kg/day. The NOAEL is 25 mg/kg/day. Parental, reproduction and offspring toxicities are observed at the limit dose, 1,000 mg/kg/day. Toxicity is manifested as decreased sperm head count in the cauda epididymidis; decreased absolute and relative weight of epididymides, cauda epididymidis and prostate; fewer implantation sites; higher post-implantation loss; and smaller litters in F0 and/or F1 animals. The parental, reproduction and offspring NOAELs are 300 mg/kg/day. A chronic study conducted with a mixture containing 22% monoethanolamine is available in the dog. Monoethanolamine administered via the diet did not cause adverse effects up to 97.5 mg/kg/day (adjusted dose, 21.45 mg/kg/day, the highest dose tested. Carcinogenicity studies with monoethanolamine are not available. However, a Derek Nexus structural alert analysis was conducted with monoethanolamine and indicated no structural alerts for carcinogenicity or mutagenicity. Therefore, monoethanolamine is not expected to be carcinogenic. Monoethanolamine is negative in an Ames test, chromosomal aberrations, sister chromosome exchange and micronucleus assay and chromosomal aberration test. It is weakly positive in the micronucleus assay. However, based on the overall weight of evidence, monoethanolamine is not considered mutagenic. Monoethanolamine administered as a vapor or liquid aerosol for 28 days causes severe lesions in the larynx, minimal to mild lesions in the nasal cavity, and minimal to mild signs of irritation in the trachea and bronchiolar epithelia at 50 mg/cubic meter (m3) (15.5 mg/kg/day). The NOAEL is 10 mg/m\3\ (3.1 mg/kg/day). Clinical signs of neurotoxicity were observed in dogs and rats via oral and inhalation routes exposure. In an inhalation toxicity study conducted in 1960, initial excitation followed by central nervous system depression was observed in dogs exposed to continuous vapors at 12-26 parts per million (ppm) for 24 hours/day, 7 days/week for 90 days. However, these observations in dogs are considered due to the exposure regime rather than neurotoxic effects. In the same study, rats continuously exposed to 5 ppm of monoethanolamine displayed lethargy after 2 to 3 weeks of exposure. However, a more recent guideline study showed that rats exposed to monoethanolamine via [[Page 17565]] inhalation for 28-days did not show central nervous system excitation, depression or lethargy. In this study, salivation was the only effect observed that suggested potential neurotoxicity but was not considered a neurotoxic effect because it is likely due to the severely irritating properties of monoethanolamine as it enters the nasal pharynx region. In a developmental toxicity study in rats, lethargy, decreased response to light cage ``tap'', increased activity and agitation were observed at 500 mg/kg/day. Conversely, these effects were not reproduced in an OECD guideline 2-generation reproductive toxicity study at doses up to 1,000 mg/kg/day. In another study, rats administered a single dose monoethanolamine via intraperitoneal injection experienced a reduction in brain (16.5%) and red blood cell (24.8%) cholinesterase levels when compared to controls. In the same study, acetylcholinesterase activity was inhibited in isolated rat brain homogenate following exposure to 3665 microgram/milliliter (ug/ml) 2-aminoethanolamine. However, the effects in both studies are seen at doses (3320 mg/kg) well above the limit dose, 1,000 mg/kg/day. Based on the overall weight of evidence from the available studies, EPA concluded that monoethanolamine is not neurotoxic. Immunotoxicity studies are not available for review. However, evidence of immunotoxicity is not observed in the submitted studies. Monoethanolamine is rapidly absorbed and metabolized. Following dermal or oral exposure, it is metabolized to acetaldehyde and ammonia. The reaction is catalyzed by ethanolamine deaminase and further degrade to CO 2 via the formation of ethanolamine-O-phosphate. In rats, the liver was the most active site of metabolism. Monoethanolamine in the liver is methylated to choline and converted to serine which in turn is made into hepatic proteins. In mice, urinary metabolites are urea and glycine, along with smaller concentrations of serine, monoethanolamine, choline and uric acid. Similarly, in rats, urinary metabolites include urea, hippuric acid and uric acid. Dermal absorption is estimated to be 60%. B. Toxicological Points of Departure/Levels of Concern Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating 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 http://www.epa.gov/pesticides/factsheets/riskassess.htm. A summary of the toxicological endpoints for monoethanolamine used for human risk assessment is shown in the Table of this unit. Table--Summary of Toxicological Doses and Endpoints for Monoethanolamine for Use in Human Risk Assessment ---------------------------------------------------------------------------------------------------------------- Point of departure Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects safety factors risk assessment ---------------------------------------------------------------------------------------------------------------- Acute dietary (Females 13-50 An acute effect was not found in the database therefore an acute dietary years of age and General assessment is not necessary. population including infants and children). ------------------------------------------------------------------------------ Chronic dietary (All populations) NOAEL = 300 mg/kg/ Chronic RfD = 3.00 Two-generation Reproduction day. mg/kg/day. Toxicity Study-Rat UFA = 10x........... cPAD = 3.00 mg/kg/ LOAEL = 1,000 mg/kg/day based on day. decreased sperm head count in the cauda epididymidis; decreased absolute and relative weight of epididymides, cauda epididymidis and prostate; fewer implantation sites; higher post-implantation loss; and smaller litters in F1 and F2 UFH = 10x........... FQPA SF = 1x........ Incidental oral short-term (1 to NOAEL = 300 mg/kg/ LOC for MOE = 100.. Two-generation Reproduction 30 days). day. Toxicity Study-Rat UFA = 10x........... LOAEL = 1,000 mg/kg/day based on decreased sperm head count in the cauda epididymidis; decreased absolute and relative weight of epididymides, cauda epididymidis and prostate; fewer implantation sites; higher post-implantation loss; and smaller litters in F1 and F2 UFH = 10x........... FQPA SF = 1x........ Incidental oral intermediate-term NOAEL = 300 mg/kg/ LOC for MOE = 100.. Two-generation Reproduction (1 to 6 months). day. Toxicity Study-Rat [[Page 17566]] UFA = 10x........... LOAEL = 1,000 mg/kg/day based on decreased sperm head count in the cauda epididymidis; decreased absolute and relative weight of epididymides, cauda epididymidis and prostate; fewer implantation sites; higher post-implantation loss; and smaller litters in F1 and F2 UFH = 10x........... FQPA SF = 1x........ Dermal short-term (1 to 30 days). NOAEL = 25 mg/kg/day LOC for MOE = 100.. Developmental Toxicity Study- Dermal-Rabbit UFA = 10x........... LOAEL = 75 mg/kg/day based on skin irritation, progressing from erythema to necrosis, scabbing and scar formation. UFH = 10x........... FQPA SF = 1x........ Dermal intermediate-term (1 to 6 NOAEL = 25 mg/kg/day LOC for MOE = 100.. Developmental Toxicity Study- months). Dermal-Rabbit UFA = 10x........... LOAEL = 75 mg/kg/day based on skin irritation, progressing from erythema to necrosis, scabbing and scar formation. UFH = 10x........... FQPA SF = 1x........ Inhalation short-term (1 to 30 Inhalation (or oral) LOC for MOE = 100.. 28 Day Inhalation Toxicity Study- days). study NOAEL= 10 mg/ Rat m\3\ (equivalent to 3.1 mg/kg/day (inhalation absorption rate = 100%). UFA = 10x........... LOAEL = 50 mg/m\3\ (equivalent to 15.5 mg/kg/day) based on local effects in the larynx, trachea and lungs. UFH = 10x........... FQPA SF = 1x........ Inhalation intermediate-(1 to 6 Inhalation (or oral) LOC for MOE = 100.. 28 Day Inhalation Toxicity Study- months). study NOAEL= 10 mg/ Rat m\3\ (equivalent to 3.1 mg/kg/day (inhalation absorption rate = 100%). UFA = 10x........... LOAEL = 50 mg/m\3\ (equivalent to 15.5 mg/kg/day) based on local effects in the larynx, trachea and lungs. UFH = 10x........... FQPA SF = 1x........ ------------------------------------------------------------------------------ Cancer (Oral, dermal, inhalation) Based on a Derek structural alert analysis and the lack of mutagenicity, monoethanolamine is considered not likely to be carcinogenic. ---------------------------------------------------------------------------------------------------------------- C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to monoethanolamine, EPA considered exposure under the proposed exemption from the requirement of a tolerance. EPA assessed dietary exposures from monoethanolamine in food as follows: Dietary exposure (food and drinking water) to monoethanolamine can occur following ingestion of foods with residues from treated crops. Because no adverse effects attributable to a single exposure of monoethanolamine are seen in the toxicity databases, an acute dietary risk assessment is not necessary. For the chronic dietary risk assessment, EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID TM, Version 3.16, and food consumption information from the U.S. Department of Agriculture's (USDA's) 2003-2008 National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in food, no residue data were submitted for monoethanolamine. In the absence of specific residue data, EPA has developed an approach which uses surrogate information to derive upper bound exposure estimates for the subject inert ingredient. Upper bound exposure estimates are based on the highest tolerance for a given commodity from a list of high use insecticides, herbicides, and fungicides. One hundred percent crop treated was assumed, default processing factors, and tolerance-level residues for all foods and use limitations of not more than 3.35% by weight in pesticide formulations. A complete description of the general approach taken to assess inert ingredient risks in the absence of residue data is contained in the memorandum entitled ``Alkyl Amines Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food and Drinking Water) Dietary Exposure and Risk Assessments for the Inerts,'' (D361707, S. Piper, 2/25/09) and can be found at http://www.regulations.gov in docket ID number EPA-HQ-OPP- 2008-0738. 2. Dietary exposure from drinking water. For the purpose of the screening-level dietary risk assessment to support this request for an exemption from the requirement of a tolerance for monoethanolamine, a conservative drinking water concentration value of [[Page 17567]] 100 parts per billion (ppb) based on screening level modeling was used to assess the contribution to drinking water for the chronic dietary risk assessments for parent compound. These values were directly entered into the dietary exposure model. 3. From non-dietary exposure. The term ``residential exposure'' is used in this document to refer to non-occupational, non-dietary exposure (e.g., textiles (clothing and diapers), carpets, swimming pools, and hard surface disinfection on walls, floors, tables). Monoethanolamine may be used as an inert ingredient in pesticide products that are registered for specific uses that may result in residential exposure, such as pesticides used in and around the home. For residential handlers, the Agency assumed handlers may receive short-term dermal and inhalation exposure to monoethanolamine from formulations containing the inert ingredient in outdoor and indoor scenarios. Intermediate-term or long-term exposure is not expected because applications are not expected to occur daily or for more than 30 days. For post-application exposures to monoethanolamine in pesticide formulations, the Agency assumed short-term dermal exposures to adults from use on treated lawns and indoor surfaces and short-term and intermediate-term dermal and oral exposures to children from treated lawns, soils, and indoor surfaces. Since monoethanolamine is not expected to be used as an inert ingredient in pesticide aerosol products such as total release insecticide foggers, and given the fact that monoethanolamine has a low vapor pressure (<1 mm Hg), it is not expected to volatilize in indoor environments; therefore, post- application inhalation exposure is not expected. A conservative residential exposure and risk assessment was completed for pesticide products containing monoethanolamine as inert ingredients. Monoethanolamine is also present in cosmetics. Although the Agency does not have data with which to quantitatively assess exposures that result from these non-pesticidal (i.e., cosmetic) uses of monoethanolamine, the Agency expects that the exposures to amounts of monoethanolamine that might result from these uses are markedly less than the conservative estimates of residential exposures resulting from pesticide use and will not add any meaningful exposure to the Agency's assessments of residential exposure from pesticide use. This is based on the typical reported concentration ranges for monoethanolamine in cosmetics, pesticidal products and the specific use patterns and anticipated likely exposure levels, including the fact that cosmetics products with monoethanolamine are designed for discontinuous, brief use followed by thorough rinsing from the surface of the skin. Therefore, the Agency believes that any contribution to aggregate exposure from these non-pesticidal uses is likely to be negligible and therefore, the assessments of exposures due to pesticide uses are protective of non-pesticidal exposures. 4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA 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 has not found monoethanolamine to share a common mechanism of toxicity with any other substances, and monoethanolamine does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that monoethanolamine 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 http://www.epa.gov/pesticides/cumulative. D. Safety Factor for Infants and Children Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) 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 database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA Safety Factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor. The toxicity database for monoethanolamine contains a subchronic, developmental, two-generation reproduction, chronic and mutagenicity studies. There is no indication of immunotoxicity in the available studies; therefore, there is no need to require an immunotoxicity study. Fetal susceptibility is not observed in the developmental or reproduction toxicity studies in rats. Reproduction toxicity (decreased sperm head count in the cauda epididymidis; decreased absolute and relative weight of epididymides, cauda epididymidis and prostate; fewer implantation sites; higher post-implantation loss) is observed at the limit dose (1,000 mg/kg/day) only. Fetal toxicity (reduced body weight) is observed in the developmental toxicity study via the dermal route of exposure in the rabbits. However, the effect occurs in the presence of maternal toxicity (skin irritation, necrosis, scabbing and scar formation). As described in detail above, signs of potential neurotoxicity are observed in dogs and rats when exposed to monoethanolamine via inhalation and intraperitoneally. However, based on the overall weight of evidence from the available studies, EPA concluded that monoethanolamine is not neurotoxic. In addition, the Agency used conservative exposure estimates, with 100 percent crop treated, tolerance-level residues, conservative drinking water modeling numbers, and a conservative assessment of potential residential exposure for infants and children. Based on the adequacy of the toxicity, the conservative nature of the exposure assessment and the lack of concern for prenatal and postnatal sensitivity, the Agency has concluded that there is reliable data to determine that infants and children will be safe if the FQPA SF of 10x is reduced to 1x. E. Aggregate Risks and Determination of Safety EPA determines whether acute and chronic dietary pesticide exposures are safe 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. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. 2. Chronic risk. Using the exposure assumptions described in this unit for [[Page 17568]] chronic exposure, EPA has concluded that chronic exposure to monoethanolamine from food and water will utilize 1.7% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure. 3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Monoethanolamine may be used as an inert ingredient in pesticide products that could result in short-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to monoethanolamine. Using the exposure assumptions described above, EPA has concluded that the combined short-term aggregated food, water, and residential exposures result in MOEs of 182 for both adult males and females. Adult residential exposure combines high-end dermal and inhalation handler exposure from liquids/trigger sprayer/home garden with a high-end post-application dermal exposure from contact with treated lawns. EPA has concluded the combined short-term aggregated food, water, and residential exposures result in an aggregate MOE of 400 for children. Children's residential exposure includes total exposures associated with contact with treated lawns (dermal and hand- to-mouth exposures). As the level of concern is for MOEs that are lower than 100, these MOEs are not of concern. Monoethanolamine is also present in some cosmetics, intended for discontinuous, brief use, followed by thorough rinsing from the surface of the skin. In the absence of actual residential exposure data resulting from such uses, the Agency considered information on the typical concentrations of monoethanolamine in cosmetics as well as typical use and likely exposures. Based on that review, the Agency believes the contribution from non-pesticidal (i.e., cosmetic) sources of monoethanolamine is likely to be insignificant compared to the exposures conservatively estimated to occur as a result of the use of monoethanolamine as an inert ingredient in pesticide formulations and that the assessments of aggregate exposures due to pesticide uses more than adequately protect for exposure from non-pesticidal uses. 4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Monoethanolamine may be used as an inert ingredient in pesticide products that could result in intermediate-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with intermediate-term residential exposures to monoethanolamine. Using the exposure assumptions described above, EPA has concluded that the combined intermediate-term aggregated food, water, and residential exposures result in aggregate MOEs of 1310 for adult males and females. Adult residential exposure combines liquids/trigger sprayer/home garden with a high-end post-application dermal exposure from contact with treated lawns. EPA has concluded the combined intermediate-term aggregated food, water, and residential exposures result in an aggregate MOE of 742 for children. Children's residential exposure includes total exposures associated with contact with treated lawns (dermal and hand- to-mouth exposures). As the level of concern is for MOEs that are lower than 100, this MOE is not of concern. Monoethanolamine is also present cosmetics. In the absence of actual residential exposure data resulting from such uses, the Agency considered information on the typical concentrations of monoethanolamine in cosmetics as well as typical use and likely exposures. Based on that review, the Agency believes the contribution from non-pesticidal sources of monoethanolamine is likely to be negligible and that the assessments of aggregate exposures due to pesticide uses more than adequately protect for exposure from non- pesticidal uses. 5. Aggregate cancer risk for U.S. population. Based on a DEREK structural alert analysis, the lack of mutagenicity and the lack of specific organ toxicity in the chronic toxicity study, monoethanolamine is not expected to pose a cancer risk to humans. 6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to monoethanolamine. V. Other Considerations A. Analytical Enforcement Methodology An analytical method is not required for enforcement purposes since the Agency is not establishing a numerical tolerance for residues of monoethanolamine in or on any food commodities. EPA is establishing a limitation on the amount of monoethanolamine that may be used in pesticide formulations applied to growing crops. That limitation will be enforced through the pesticide registration process under the Federal Insecticide, Fungicide, and Rodenticide Act (``FIFRA''), 7 U.S.C. 136 et seq. EPA will not register any pesticide formulation for use on growing crops for sale or distribution that exceeds 3.35% by weight of monoethanolamine. B. Revisions to Petitioned-For Tolerances Based upon an evaluation of the data included in the petition, EPA is establishing an exemption from the requirement of a tolerance for residues of monoethanolamine when used in pesticide formulations as an inert ingredient (solvent/co-solvent), not to exceed 3.35% by weight of the formulation, instead of the unlimited use requested. Because unlimited use of monoethanolamine resulted in aggregate risks of concern, the EPA is establishing a 3.35% limitation by weight of formulation to support the safety finding of this tolerance exemption. The concern for unlimited use of this inert ingredient is documented on page 5 of the Agency's risk assessment document ``Monoethanolamine; Human Health Risk Assessment and Ecological Effects Assessment to Support Proposed Exemption from the Requirement of a Tolerance When Used as an Inert Ingredient in Pesticide Formulations,'' which can be found at http://www.regulations.gov in docket ID number EPA-HQ-OPP- 2015-0697. VI. Conclusions Therefore, an exemption from the requirement of a tolerance is established under 40 CFR 180.910 for residues of monoethanolamine (CAS Reg. No. 141-43-5) when used as an inert ingredient (solvent/co- solvent) at a maximum concentration of 3.35% by weight in pesticide formulations applied to growing crops or raw agricultural commodities after harvest. VII. Statutory and Executive Order Reviews This action establishes an exemption to the requirement for a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled ``Regulatory Planning and Review'' (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is [[Page 17569]] not subject to Executive Order 13211, entitled ``Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of Children from Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled ``Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations'' (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the exemption 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. This action directly regulates growers, food processors, food handlers, and food retailers, 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.). 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 (NTTAA) (15 U.S.C. 272 note). VIII. Congressional Review Act Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 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 the rule in the Federal Register. This action is not a ``major rule'' as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: March 7, 2017. Michael Goodis, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180--[AMENDED] 0 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371. 0 2. In Sec. 180.910, add alphabetically the inert ingredient to the table to read as follows: Sec. 180.910 Inert ingredients used pre- and post-harvest; exemptions from the requirement of a tolerance. * * * * * ------------------------------------------------------------------------ Inert ingredients Limits Uses ------------------------------------------------------------------------ * * * * * * * Monoethanolamine (CAS Reg. No. Not to exceed 3.35% by Solvent. 141-43-5). weight in pesticide formulation. * * * * * * * ------------------------------------------------------------------------ [FR Doc. 2017-07130 Filed 4-11-17; 8:45 am] BILLING CODE 6560-50-P
![Federal Register / Vol. 82, No. 69 / Wednesday, April 12, 2017 / Rules and Regulations 17563
ENVIRONMENTAL PROTECTION DC 20460–0001; main telephone by docket ID number EPA–HQ–OPP–
AGENCY number: (703) 305–7090; email address: 2015–0697, by one of the following
RDFRNotices@epa.gov. methods:
40 CFR Part 180 SUPPLEMENTARY INFORMATION: • Federal eRulemaking Portal: http://
[EPA–HQ–OPP–2015–0697; FRL–9949–11]
www.regulations.gov. Follow the online
I. General Information instructions for submitting comments.
Monoethanolamine; Exemption From A. Does this action apply to me? Do not submit electronically any
the Requirement of a Tolerance information you consider to be CBI or
You may be potentially affected by other information whose disclosure is
AGENCY: Environmental Protection this action if you are an agricultural restricted by statute.
Agency (EPA). producer, food manufacturer, or • Mail: OPP Docket, Environmental
ACTION: Final rule. pesticide manufacturer. The following Protection Agency Docket Center (EPA/
list of North American Industrial DC), (28221T), 1200 Pennsylvania Ave.
SUMMARY: This regulation establishes an Classification System (NAICS) codes is NW., Washington, DC 20460–0001.
exemption from the requirement of a not intended to be exhaustive, but rather • Hand Delivery: To make special
tolerance for residues of provides a guide to help readers arrangements for hand delivery or
monoethanolamine (CAS Reg. No. 141– determine whether this document delivery of boxed information, please
43–5) when used as an inert ingredient applies to them. Potentially affected follow the instructions at http://
(solvent) in pesticides applied to entities may include: www.epa.gov/dockets/contacts.html.
growing crops and raw agricultural • Crop production (NAICS code 111). Additional instructions on
commodities after harvest limited to a • Animal production (NAICS code commenting or visiting the docket,
maximum concentration of 3.35% by 112). along with more information about
weight in the pesticide formulation. • Food manufacturing (NAICS code dockets generally, is available at http://
Technology Sciences Group Inc., on 311). www.epa.gov/dockets.
behalf of Doosan Corporation, submitted • Pesticide manufacturing (NAICS
a petition to EPA under the Federal code 32532). II. Petition for Exemption
Food, Drug, and Cosmetic Act (FFDCA), In the Federal Register of November
B. How can I get electronic access to
requesting establishment of an 23, 2015 (80 FR 72941) (FRL–9936–73),
other related information?
exemption from the requirement of a EPA issued a document pursuant to
tolerance. This regulation eliminates the You may access a frequently updated FFDCA section 408, 21 U.S.C. 346a,
need to establish a maximum electronic version of 40 CFR part 180 announcing the filing of a pesticide
permissible level for residues of through the Government Printing petition (PP IN–10839) by Technology
monoethanolamine when used in Office’s e-CFR site at http:// Sciences Group Inc. (1150 18th Street
accordance with the approved www.ecfr.gov/cgi-bin/text- NW., Suite 1000, Washington, DC
concentrations. idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 20036) on behalf of Doosan Corporation
DATES: This regulation is effective April
40tab_02.tpl. (864 B/5F, Aict, 864–1, lui-dong,
12, 2017. Objections and requests for C. How can I file an objection or hearing Yeongtong-gu, Suwon-si, Gyeonggi-do,
hearings must be received on or before request? 443–284, Republic of Korea). The
June 12, 2017, and must be filed in petition requested that 40 CFR 180.910
Under FFDCA section 408(g), 21 be amended by establishing an
accordance with the instructions
U.S.C. 346a, any person may file an exemption from the requirement of a
provided in 40 CFR part 178 (see also
objection to any aspect of this regulation tolerance for residues of
Unit I.C. of the SUPPLEMENTARY
and may also request a hearing on those monoethanolamine (CAS Reg. No. 141–
INFORMATION).
objections. You must file your objection 43–5) when used as an inert ingredient
ADDRESSES: The docket for this action, or request a hearing on this regulation (solvent) in pesticide formulations
identified by docket identification (ID) in accordance with the instructions applied to growing crops and raw
number EPA–HQ–OPP–2015–0697, is provided in 40 CFR part 178. To ensure agricultural commodities after harvest.
available at http://www.regulations.gov proper receipt by EPA, you must That document referenced a summary of
or at the Office of Pesticide Programs identify docket ID number EPA–HQ– the petition prepared by Technology
Regulatory Public Docket (OPP Docket) OPP–2015–0697 in the subject line on Sciences Group Inc. on behalf of Doosan
in the Environmental Protection Agency the first page of your submission. All Corporation, the petitioner, which is
Docket Center (EPA/DC), West William objections and requests for a hearing available in the docket, http://
Jefferson Clinton Bldg., Rm. 3334, 1301 must be in writing, and must be www.regulations.gov. There were no
Constitution Ave. NW., Washington, DC received by the Hearing Clerk on or comments received in response to the
20460–0001. The Public Reading Room before June 12, 2017. Addresses for mail notice of filing.
is open from 8:30 a.m. to 4:30 p.m., and hand delivery of objections and Based upon review of the data
Monday through Friday, excluding legal hearing requests are provided in 40 CFR supporting the petition, EPA has limited
holidays. The telephone number for the 178.25(b). the maximum concentration of
Public Reading Room is (202) 566–1744, In addition to filing an objection or monoethanolamine to 3.35% by weight
and the telephone number for the OPP hearing request with the Hearing Clerk in pesticide formulations. The reason
Docket is (703) 305–5805. Please review as described in 40 CFR part 178, please for this change is explained in Unit V.B.
the visitor instructions and additional submit a copy of the filing (excluding below.
pmangrum on DSK3GDR082PROD with RULES
information about the docket available any Confidential Business Information
at http://www.epa.gov/dockets. (CBI)) for inclusion in the public docket. III. Inert Ingredient Definition
FOR FURTHER INFORMATION CONTACT: Information not marked confidential Inert ingredients are all ingredients
Michael Goodis, Registration Division pursuant to 40 CFR part 2 may be that are not active ingredients as defined
(7505P), Office of Pesticide Programs, disclosed publicly by EPA without prior in 40 CFR 153.125 and include, but are
Environmental Protection Agency, 1200 notice. Submit the non-CBI copy of your not limited to, the following types of
Pennsylvania Ave. NW., Washington, objection or hearing request, identified ingredients (except when they have a
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![Federal Register / Vol. 82, No. 69 / Wednesday, April 12, 2017 / Rules and Regulations 17569
not subject to Executive Order 13211, section 408(n)(4). As such, the Agency other required information to the U.S.
entitled ‘‘Actions Concerning has determined that this action will not Senate, the U.S. House of
Regulations That Significantly Affect have a substantial direct effect on States Representatives, and the Comptroller
Energy Supply, Distribution, or Use’’ (66 or tribal governments, on the General of the United States prior to
FR 28355, May 22, 2001) or Executive relationship between the national publication of the rule in the Federal
Order 13045, entitled ‘‘Protection of government and the States or tribal Register. This action is not a ‘‘major
Children from Environmental Health governments, or on the distribution of rule’’ as defined by 5 U.S.C. 804(2).
Risks and Safety Risks’’ (62 FR 19885, power and responsibilities among the
April 23, 1997). This action does not List of Subjects in 40 CFR Part 180
various levels of government or between
contain any information collections the Federal Government and Indian Environmental protection,
subject to OMB approval under the tribes. Thus, the Agency has determined Administrative practice and procedure,
Paperwork Reduction Act (PRA) (44 that Executive Order 13132, entitled Agricultural commodities, Pesticides
U.S.C. 3501 et seq.), nor does it require ‘‘Federalism’’ (64 FR 43255, August 10, and pests, Reporting and recordkeeping
any special considerations under 1999) and Executive Order 13175, requirements.
Executive Order 12898, entitled entitled ‘‘Consultation and Coordination Dated: March 7, 2017.
‘‘Federal Actions to Address with Indian Tribal Governments’’ (65 FR
Michael Goodis,
Environmental Justice in Minority 67249, November 9, 2000) do not apply
Populations and Low-Income Director, Registration Division, Office of
to this action. In addition, this action
Pesticide Programs.
Populations’’ (59 FR 7629, February 16, does not impose any enforceable duty or
1994). contain any unfunded mandate as Therefore, 40 CFR chapter I is
Since tolerances and exemptions that described under Title II of the Unfunded amended as follows:
are established on the basis of a petition Mandates Reform Act (UMRA) (2 U.S.C.
under FFDCA section 408(d), such as PART 180—[AMENDED]
1501 et seq.).
the exemption in this final rule, do not This action does not involve any
require the issuance of a proposed rule, technical standards that would require ■ 1. The authority citation for part 180
the requirements of the Regulatory Agency consideration of voluntary continues to read as follows:
Flexibility Act (RFA) (5 U.S.C. 601 et consensus standards pursuant to section Authority: 21 U.S.C. 321(q), 346a and 371.
seq.), do not apply. 12(d) of the National Technology ■ 2. In § 180.910, add alphabetically the
This action directly regulates growers, Transfer and Advancement Act inert ingredient to the table to read as
food processors, food handlers, and food (NTTAA) (15 U.S.C. 272 note). follows:
retailers, not States or tribes, nor does
this action alter the relationships or VIII. Congressional Review Act § 180.910 Inert ingredients used pre- and
distribution of power and Pursuant to the Congressional Review post-harvest; exemptions from the
responsibilities established by Congress Act (5 U.S.C. 801 et seq.), EPA will requirement of a tolerance.
in the preemption provisions of FFDCA submit a report containing this rule and * * * * *
Inert ingredients Limits Uses
* * * * * * *
Monoethanolamine (CAS Reg. No. 141–43–5) ................ Not to exceed 3.35% by weight in pesticide formulation Solvent.
* * * * * * *
[FR Doc. 2017–07130 Filed 4–11–17; 8:45 am] SUMMARY: On September 14, 2016, the HHS select agents and toxins as a Tier
BILLING CODE 6560–50–P Centers for Disease Control and 1 select agent (81 FR 63138, September
Prevention (CDC) in the Department of 14, 2016). In the interim final rule,
Health and Human Services (HHS) HHS/CDC invited comments on the
published in the Federal Register (81 following questions:
DEPARTMENT OF HEALTH AND
FR 63138) an interim final rule and (1) Are there other virulent (pBCXO1+
HUMAN SERVICES
request for comments which added and pBCXO2+) strains of Bacillus
42 CFR Part 73 Bacillus cereus Biovar anthracis to the species that should also be regulated?
list of HHS select agents and toxins as (2) What is the impact of designating
[CDC Docket No. CDC–2016–0045] a Tier 1 select agent. CDC received two B. cereus Biovar anthracis as a Tier 1
comments, both of which supported the select agent?
RIN 0920–AA64 rule change. The comment period ended
DATES: Effective April 12, 2017. November 14, 2016.
Possession, Use, and Transfer of We received two comments, both of
Select Agents and Toxins—Addition of FOR FURTHER INFORMATION CONTACT: Dr.
which supported adding B. cereus
Bacillus cereus Biovar anthracis to Samuel Edwin, Director, Division of
Biovar anthracis to the list of HHS select
the HHS List of Select Agents and Select Agents and Toxins, Centers for
agents and toxins. While both
pmangrum on DSK3GDR082PROD with RULES
Toxins Disease Control and Prevention, 1600
commenters supported the addition, one
Clifton Road NE., MS–A46, Atlanta,
AGENCY: Centers for Disease Control and commented that the regulation of B.
Georgia 30329. Telephone: (404) 718–
Prevention (CDC), Department of Health cereus Biovar anthracis will ‘‘restrict
2000.
and Human Services (HHS). the ability of future laboratories and
SUPPLEMENTARY INFORMATION: Effective organizations to test for and analyze
ACTION: Interim rule; adoption as final
on October 14, 2016, Bacillus cereus possible pBXO1 and pBXO2 isolates.’’
and response to public comments.
Biovar anthracis was added to the list of The commenter further argued that
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Document Created: 2017-04-12 00:23:05
Document Modified: 2017-04-12 00:23:05
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule. | |
| Dates | This regulation is effective April 12, 2017. Objections and requests for hearings must be received on or before June 12, 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). | |
| Contact | Michael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone | |
| FR Citation | 82 FR 17563 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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