Diisopropanolamine; Exemption From the Requirement of a Tolerance, 73218-73224 [2014-28955]

Download as PDF 73218 Federal Register / Vol. 79, No. 237 / Wednesday, December 10, 2014 / Rules and Regulations rmajette on DSK2VPTVN1PROD with RULES hexythiazox, in or on beet, sugar, root at 0.15 ppm. This tolerance expires on December 31, 2019. VII. Statutory and Executive Order Reviews This action establishes tolerances under FFDCA sections 408(e) and 408(l)(6). 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 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 in accordance with FFDCA sections 408(e) and 408(l)(6), such as the tolerances 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 VerDate Sep<11>2014 12:45 Dec 09, 2014 Jkt 235001 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: December 3, 2014. Susan Lewis, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. 2. In § 180.448, revise paragraph (b) to read as follows: ■ § 180.448 residues. Hexythiazox; tolerance for * * * * * (b) Section 18 emergency exemptions. A time-limited tolerance specified in the following table is established for residues of hexythiazox and its metabolites containing the (4chlorophenyl)-4-methyl-2-oxo-3thiazolidine moiety, calculated as the stoichiometric equivalent of hexythiazox, in or on the specified agricultural commodity, resulting from use of the pesticide pursuant to FIFRA section 18 emergency exemptions. The tolerance expires on the date specified in the table. Commodity Parts per million Expiration date Beet, sugar, root ... 0.15 12/31/19 PO 00000 Frm 00028 Fmt 4700 Sfmt 4700 * * * * * [FR Doc. 2014–28935 Filed 12–9–14; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2013–0695; FRL–9919–34] Diisopropanolamine; Exemption From the Requirement of a Tolerance Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes an exemption from the requirement of a tolerance for residues of diisopropanolamine when used as an inert ingredient (neutralizer or stabilizer) at no more than 10% in pesticide formulations applied to growing crops or to raw agricultural commodities after harvest. United Phosphorus, Inc. 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 diisopropanolamine. DATES: This regulation is effective December 10, 2014. Objections and requests for hearings must be received on or before February 9, 2015, 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–2013–0695, 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: Susan T. Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001; main telephone SUMMARY: E:\FR\FM\10DER1.SGM 10DER1 Federal Register / Vol. 79, No. 237 / Wednesday, December 10, 2014 / Rules and Regulations number: (703) 305–7090; email address: RDFRNotices@epa.gov. 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/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 40tab_02.tpl. rmajette on DSK2VPTVN1PROD with RULES 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–2013–0695 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 February 9, 2015. 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– VerDate Sep<11>2014 12:45 Dec 09, 2014 Jkt 235001 2013–0695, 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 August 1, 2014 (79 FR 44729) (FRL–9911–67), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP IN–10626) by United Phosphorus, Inc., 630 Freedom Business Center Suite 402, King of Prussia, PA 19406. The petition requested that 40 CFR 180.910 be amended by establishing an exemption from the requirement of a tolerance for residues of diisopropanolamine (CAS Reg. No. 110–97–4) when used as an inert ingredient neutralizer or stabilizer in pesticide formulations applied to growing crops or raw agricultural commodities after harvest at not more than 10% by weight in a pesticide formulation. That document referenced a summary of the petition prepared by Pyxis Regulatory Consulting, the petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing. 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 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 PO 00000 Frm 00029 Fmt 4700 Sfmt 4700 73219 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 E:\FR\FM\10DER1.SGM 10DER1 73220 Federal Register / Vol. 79, No. 237 / Wednesday, December 10, 2014 / Rules and Regulations diisopropanolamine including exposure resulting from the exemption established by this action. EPA’s assessment of exposures and risks associated with diisopropanolamine 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 diisopropanolamine as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the toxicity studies are discussed in this unit. The acute oral toxicity of diisopropanolamine is low. The acute oral Lethal Dose (LD)50s in rats are all >2,000 milligram/kilogram body weight (mg/kg bw). The acute dermal toxicity in rats and rabbits is >8,000 mg/kg bw. Diisopropanolamine is an eye irritant based on a primary eye irritation study in rabbits. Diisopropanolamine is dermally irritating based on a primary skin irritation study in rabbits with erythema after 24 hours and scaling after 8 days. Diisopropanolamine is not a dermal sensitizer. Two subchronic oral toxicity studies using diisopropanolamine on rats were available. In the 14-day study the noobserved-adverse-effect-level (NOAEL) was 600 mg/kg/day in males and females based on decreased body weight gain and relative kidney weight increases at 1,200 mg/kg/day. In the 90day study the NOAEL was 100 mg/kg/ day (males) based on increased absolute and relative kidney weights at 500 mg/ kg/day and 500 mg/kg/day (females) based on increases in absolute and relative kidney weights at 1,000 mg/kg/ day. There was also a 28-day dermal toxicity study with diisopropanolamine in which the NOAEL was the limit dose of 750 mg/kg/day for systemic effects. In a developmental toxicity study in rats with diisopropanolamine, no observed adverse effects were seen at the limit dose of 1,000 mg/kg/day for both maternal and developmental toxicity. In an in vitro mammalian cell gene mutation test, two bacterial reverse mutation tests and an in vitro mammalian chromosomal aberration test, results for mutagenicity and genotoxicity were negative for diisopropanolamine. In a carcinogenicity study in rats dosed at 1% (∼1,000 mg/kg/day) diisopropanolamine for 94 weeks, no increase in incidence of tumors over controls was observed under the conditions of the study. No immunotoxicity or neurotoxicity studies on diisopropanolamine were available in the database. However, evidence of immunotoxicity or neurotoxicity was not observed in the submitted studies. A dermal metabolism and dermal absorption study on diisopropanolamine were provided. Based on the study, i.v. administration of radioactive labeled diisopropanolamine rapidly decreased in plasma and was undetectable at 18 and 24 hours. 96.8% of the administered dose of diisopropanolamine was excreted in urine and none was detectable in the feces. The dermal administration portion of the study determined that ∼20% was absorbed within 48 hours. Most of the radiolabeled diisopropanolamine was excreted in urine. The application site contained 49% of the applied diisopropanolamine. Little diisopropanolamine was observed in the feces. The total recovered dose was 69.2%. The absolute dermal absorption of diisopropanolamine was calculated to be 12%. 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 (U/SF) 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 nonthreshold 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 diisopropanolamine used for human risk assessment is shown in Table 1 of this unit. TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR DIISOPROPANOLAMINE FOR USE IN HUMAN RISK ASSESSMENT Exposure/scenario Acute dietary (General population including infants and children). rmajette on DSK2VPTVN1PROD with RULES Chronic dietary (All populations) VerDate Sep<11>2014 12:45 Dec 09, 2014 Point of departure and uncertainty/ safety factors RfD, PAD, LOC for risk assessment Study and toxicological effects An acute effect was not found in the database therefore an acute dietary assessment is not necessary. NOAEL = 100 mg/ kg/day. UFA = 10x UFH = 10x FQPA SF = 1x Jkt 235001 PO 00000 Chronic RfD = 100 mg/kg/day. cPAD = 1.0 mg/kg/ day Frm 00030 Fmt 4700 90-day oral toxicity—rat. LOAEL = 500 mg/kg/day based on based on increase in relative and absolute kidney weight. Sfmt 4700 E:\FR\FM\10DER1.SGM 10DER1 Federal Register / Vol. 79, No. 237 / Wednesday, December 10, 2014 / Rules and Regulations 73221 TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR DIISOPROPANOLAMINE FOR USE IN HUMAN RISK ASSESSMENT—Continued Exposure/scenario Incidental oral short-term (1 to 30 days). Incidental oral intermediateterm (1 to 6 months). Point of departure and uncertainty/ safety factors Study and toxicological effects LOC for MOE = 100 90-day oral toxicity—rat. LOAEL = 500 mg/kg/day based on based on increase in relative and absolute kidney weight. LOC for MOE = 100 NOAEL = 100 mg/ kg/day. UFA = 10x UFH = 10x FQPA SF = 1x NOAEL = 100 mg/ kg/day. UFA = 10x UFH = 10x FQPA SF = 1x RfD, PAD, LOC for risk assessment 90-day oral toxicity—rat. LOAEL = 500 mg/kg/day based on increase in relative and absolute kidney weight. Dermal short- and intermediateterm. Dermal exposure was not assessed because no systemic toxicity was identified at the limit dose of 750 mg/kg/ day in a dermal toxicity study. Inhalation short-term (1 to 30 days). oral study NOAEL = 100 mg/kg/day (inhalation absorption rate = 100%). UFA = 10x UFH = 10x FQPA SF = 1x LOC for MOE = 100 90-day oral toxicity—rat. LOAEL = 500 mg/kg/day based on based on increase in relative and absolute kidney weight. Inhalation (1 to 6 months) ......... oral study NOAEL = 100 mg/kg/day (inhalation absorption rate = 100%). UFA = 10x UFH = 10x FQPA SF = 1x LOC for MOE = 100 90-day oral toxicity—rat. LOAEL = 500 mg/kg/day based on based on increase in relative and absolute kidney weight. Cancer (Oral, dermal, inhalation). Based on the lack of increased incidence of tumor formation compared to controls in a carcinogenicity study and the lack of mutagenicity, diisopropanolamine is considered not likely to be carcinogenic. rmajette on DSK2VPTVN1PROD with RULES FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to diisopropanolamine, EPA considered exposure under the proposed exemption from the requirement of a tolerance (40 CFR 180.910 as an inert ingredient used in pesticide formulations applied to growing crops). EPA assessed dietary exposures from diisopropanolamine in food as follows: Because an acute endpoint of concern was not identified, an acute dietary exposure assessment is unnecessary. The chronic dietary exposure assessment for this inert ingredient utilizes the Dietary Exposure Evaluation Model Food Commodity Intake Database (DEEM–FCID), Version 3.16, EPA, which includes food consumption information from the U.S. Department of Agriculture’s National Health and Nutrition Examination Survey, ‘‘What We Eat in America’’, (NHANES/ WWEIA). This dietary survey was conducted from 2003 to 2008. In the absence of actual residue data, the inert VerDate Sep<11>2014 12:45 Dec 09, 2014 Jkt 235001 ingredient evaluation is based on a highly conservative model which assumes that the residue level of the inert ingredient would be no higher than the highest established tolerance for an active ingredient on a given commodity. Implicit in this assumption is that there would be similar rates of degradation between the active and inert ingredient (if any) and that the concentration of inert ingredient in the scenarios leading to these highest of tolerances would be no higher than the concentration of the active ingredient. The model assumes 100 percent crop treated (PCT) for all crops and that every food eaten by a person each day has tolerance-level residues. 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 PO 00000 Frm 00031 Fmt 4700 Sfmt 4700 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 diisopropanolamine, a conservative drinking water concentration value of 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 nonoccupational, non-dietary exposure (e.g., textiles (clothing and diapers), carpets, swimming pools, and hard surface disinfection on walls, floors, tables). Diisopropanolamine is used as an inert ingredient in pesticide products that could result in short- and intermediate-term residential exposure, E:\FR\FM\10DER1.SGM 10DER1 73222 Federal Register / Vol. 79, No. 237 / Wednesday, December 10, 2014 / Rules and Regulations rmajette on DSK2VPTVN1PROD with RULES and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short- and intermediate-term residential exposures to diisopropanolamine. Possible routes of exposure include dermal and/or inhalation exposure to outdoor lawn and turf use (i.e. low pressure handwand, hose end sprayer and trigger sprayers). 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 diisopropanolamine to share a common mechanism of toxicity with any other substances, and diisopropanolamine does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that diisopropanolamine 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 1. In general. 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 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. 2. Prenatal and postnatal sensitivity. Fetal susceptibility was not observed in developmental studies with rats administered diisopropanolamine. Treatment with diisopropanolamine had no effect on body weight gain or food consumption during the dosing period, kidney or liver weights, gravid uterine weight, number of corpora lutea, VerDate Sep<11>2014 12:45 Dec 09, 2014 Jkt 235001 implantations or resorptions, percent pre- and post-implantation loss, mean fetal weight or males or females, fetal sex ratio or the number of viable fetuses. There were no statistically significant increases in abnormalities (external, visceral or skeletal) in any treatment group compared to the control. 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. That decision is based on the following findings: i. The toxicity database for diisopropanolamine contains the following acceptable studies: Subchronic, developmental, and chronic/carcinogenicity studies, several mutagenicity studies, and a dermal metabolism and absorption study. No repeated dose inhalation toxicity study is available in the database, however all inhalation MOEs, which are based on the POD from the 90-day oral toxicity study, are greater than 15,000. The Agency does not believe that any inhalation study would provide a POD so substantially different from the POD in the 90-day oral toxicity study to result in a risk of concern from inhalation exposure; therefore, there is no need to include an additional uncertainty factor to account for the lack of inhalation data. ii. There is no indication that diisopropanolamine is a neurotoxic chemical. Although no neurotoxicity studies were available in the database, no clinical signs of neurotoxicity were observed in the available subchronic and chronic studies. Therefore, there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. iii. Based on the discussion above, there is no concern that diisopropanolamine results in increased susceptibility in the prenatal developmental studies. iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100% CT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to diisopropanolamine in drinking water. EPA used similarly conservative assumptions to assess postapplication exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by diisopropanolamine. PO 00000 Frm 00032 Fmt 4700 Sfmt 4700 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. Therefore, diisopropanolamine is not expected to pose an acute risk. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to diisopropanolamine from food and water will utilize 14.1% 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). Diisopropanolamine is currently used as an inert ingredient in pesticide products that are registered for uses 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 diisopropanolamine. Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 2,600 for both adult males and females respectively. EPA has concluded the combined short-term aggregated food, water, and residential exposure results in an aggregate MOE of 680 for children. Children’s residential exposure includes total exposures associated with contact with treated surfaces (hand-to-mouth exposure). Because EPA’s level of concern for diisopropanolamine is a MOE of 100 or below, these MOEs are not of concern. 4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic E:\FR\FM\10DER1.SGM 10DER1 73223 Federal Register / Vol. 79, No. 237 / Wednesday, December 10, 2014 / Rules and Regulations exposure to food and water (considered to be a background exposure level). Diisopropanolamine is currently used as an inert ingredient in pesticide products that are registered for uses 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 diisopropanolamine. Using the exposure assumptions described in this unit for intermediateterm exposures, EPA has concluded that the combined intermediate-term food, water, and residential exposures result in aggregate MOEs of 2,600 for adult males and females. EPA has concluded the combined intermediate-term aggregated food, water, and residential exposures result in an aggregate MOE of 690 for children. Children’s residential exposure includes total exposures associated with contact with treated surfaces (hand-to-mouth exposure). Because EPA’s level of concern for diisopropanolamine is a MOE of 100 or below, these MOEs are not of concern. 5. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in adequate rodent carcinogenicity study, diisopropanolamine 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 diisopropanolamine residues. V. Analytical Enforcement Methodology An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation. rmajette on DSK2VPTVN1PROD with RULES VI. Conclusions Therefore, an exemption from the requirement of a tolerance is established under 40 CFR 180.910 for diisopropanolamine (CAS Reg. No. 110– 97–4) when used as an inert ingredient (neutralizer or stabilizer) in pesticide formulations applied to growing crops or raw agricultural commodities after harvest at not more than 10% by weight in pesticide formulations. VII. Statutory and Executive Order Reviews This action establishes an exemption from the requirement of 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 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 Inert ingredients VerDate Sep<11>2014 * 12:45 Dec 09, 2014 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: November 26, 2014. Susan Lewis, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. 2. In § 180.910, add alphabetically the inert ingredient to the table to read as follows: ■ § 180.910 Inert ingredients used pre- and post-harvest; exemptions from the requirement of a tolerance. * * * * PO 00000 * Uses * * * * Not to exceed 10% by weight of pesticide formulation .. Neutralizer or stabilizer. * Jkt 235001 VIII. Congressional Review Act Limits * * * Diisopropanolamine (CAS Reg. No. 110–97–4) ............. * 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). * Frm 00033 Fmt 4700 * Sfmt 4700 E:\FR\FM\10DER1.SGM * 10DER1 * 73224 Federal Register / Vol. 79, No. 237 / Wednesday, December 10, 2014 / Rules and Regulations BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY DC 20460–0001; main telephone number: (703) 305–7090; email address: RDFRNotices@epa.gov. SUPPLEMENTARY INFORMATION: I. General Information [FR Doc. 2014–28955 Filed 12–9–14; 8:45 am] 40 CFR Part 180 [EPA–HQ–OPP–2014–0122; FRL–9919–40] C.I. Pigment Yellow 1; Exemption From the Requirement of a Tolerance Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes an exemption from the requirement of a tolerance for residues of C.I. Pigment Yellow 1 (butanamide, 2- (4-methyl-2nitrophenyl) azo -3-oxo-N-phenyl-) when used as an inert ingredient as a colorant in seed treatment formulations not to exceed 10% weight(wt)/wt under 40 CFR 180.920. Exponent Inc. on behalf of Clariant 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 C.I. Pigment Yellow 1. DATES: This regulation is effective December 10, 2014. Objections and requests for hearings must be received on or before February 9, 2015, 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–2014–0122, 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: Susan T. Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, rmajette on DSK2VPTVN1PROD with RULES SUMMARY: VerDate Sep<11>2014 12:45 Dec 09, 2014 Jkt 235001 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/textidx?&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–2014–0122 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 February 9, 2015. 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– PO 00000 Frm 00034 Fmt 4700 Sfmt 4700 2014–0122, 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 October 24, 2014 (79 FR 63594) (FRL–9916–03), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP IN–10661) by Exponent, Inc. (1150 Connecticut Ave. NW., Suite 1100, Washington, DC 20036) on behalf of Clariant Corporation (4000 Monroe Road, Charlotte, NC 28205). The petition requested that 40 CFR 180.920 be amended by establishing an exemption from the requirement of a tolerance for residues of C.I. Pigment Yellow 1 (butanamide, 2- (4-methyl-2nitrophenyl) azo -3-oxo-N-phenyl-) (CAS Reg. No. 2512–29–0) when used as an inert ingredient as a colorant in pesticide formulations applied as a seed treatment not to exceed 10% wt/wt. That document referenced a summary of the petition prepared by Exponent, Inc., the petitioner, which is available in the docket, http://www.regulations.gov. Comments were received on the notice of filing. EPA’s response to these comments is discussed in Unit V.C. 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 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; E:\FR\FM\10DER1.SGM 10DER1

Agencies

[Federal Register Volume 79, Number 237 (Wednesday, December 10, 2014)]
[Rules and Regulations]
[Pages 73218-73224]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-28955]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0695; FRL-9919-34]


Diisopropanolamine; 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 diisopropanolamine when used as an inert 
ingredient (neutralizer or stabilizer) at no more than 10% in pesticide 
formulations applied to growing crops or to raw agricultural 
commodities after harvest. United Phosphorus, Inc. 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 diisopropanolamine.

DATES: This regulation is effective December 10, 2014. Objections and 
requests for hearings must be received on or before February 9, 2015, 
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-2013-0695, 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: Susan T. Lewis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone

[[Page 73219]]

number: (703) 305-7090; email address: RDFRNotices@epa.gov.

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-2013-0695 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 
February 9, 2015. 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-2013-0695, 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 August 1, 2014 (79 FR 44729) (FRL-9911-
67), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the filing of a pesticide petition (PP IN-10626) by 
United Phosphorus, Inc., 630 Freedom Business Center Suite 402, King of 
Prussia, PA 19406. The petition requested that 40 CFR 180.910 be 
amended by establishing an exemption from the requirement of a 
tolerance for residues of diisopropanolamine (CAS Reg. No. 110-97-4) 
when used as an inert ingredient neutralizer or stabilizer in pesticide 
formulations applied to growing crops or raw agricultural commodities 
after harvest at not more than 10% by weight in a pesticide 
formulation. That document referenced a summary of the petition 
prepared by Pyxis Regulatory Consulting, the petitioner, which is 
available in the docket, http://www.regulations.gov. There were no 
comments received in response to the notice of filing.

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 
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

[[Page 73220]]

diisopropanolamine including exposure resulting from the exemption 
established by this action. EPA's assessment of exposures and risks 
associated with diisopropanolamine 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 diisopropanolamine 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 toxicity of diisopropanolamine is low. The acute 
oral Lethal Dose (LD)50s in rats are all >2,000 milligram/
kilogram body weight (mg/kg bw). The acute dermal toxicity in rats and 
rabbits is >8,000 mg/kg bw. Diisopropanolamine is an eye irritant based 
on a primary eye irritation study in rabbits. Diisopropanolamine is 
dermally irritating based on a primary skin irritation study in rabbits 
with erythema after 24 hours and scaling after 8 days. 
Diisopropanolamine is not a dermal sensitizer.
    Two subchronic oral toxicity studies using diisopropanolamine on 
rats were available. In the 14-day study the no-observed-adverse-
effect-level (NOAEL) was 600 mg/kg/day in males and females based on 
decreased body weight gain and relative kidney weight increases at 
1,200 mg/kg/day. In the 90-day study the NOAEL was 100 mg/kg/day 
(males) based on increased absolute and relative kidney weights at 500 
mg/kg/day and 500 mg/kg/day (females) based on increases in absolute 
and relative kidney weights at 1,000 mg/kg/day. There was also a 28-day 
dermal toxicity study with diisopropanolamine in which the NOAEL was 
the limit dose of 750 mg/kg/day for systemic effects.
    In a developmental toxicity study in rats with diisopropanolamine, 
no observed adverse effects were seen at the limit dose of 1,000 mg/kg/
day for both maternal and developmental toxicity.
    In an in vitro mammalian cell gene mutation test, two bacterial 
reverse mutation tests and an in vitro mammalian chromosomal aberration 
test, results for mutagenicity and genotoxicity were negative for 
diisopropanolamine.
    In a carcinogenicity study in rats dosed at 1% (~1,000 mg/kg/day) 
diisopropanolamine for 94 weeks, no increase in incidence of tumors 
over controls was observed under the conditions of the study.
    No immunotoxicity or neurotoxicity studies on diisopropanolamine 
were available in the database. However, evidence of immunotoxicity or 
neurotoxicity was not observed in the submitted studies.
    A dermal metabolism and dermal absorption study on 
diisopropanolamine were provided. Based on the study, i.v. 
administration of radioactive labeled diisopropanolamine rapidly 
decreased in plasma and was undetectable at 18 and 24 hours. 96.8% of 
the administered dose of diisopropanolamine was excreted in urine and 
none was detectable in the feces. The dermal administration portion of 
the study determined that ~20% was absorbed within 48 hours. Most of 
the radiolabeled diisopropanolamine was excreted in urine. The 
application site contained 49% of the applied diisopropanolamine. 
Little diisopropanolamine was observed in the feces. The total 
recovered dose was 69.2%. The absolute dermal absorption of 
diisopropanolamine was calculated to be 12%.

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 (U/SF) 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 diisopropanolamine 
used for human risk assessment is shown in Table 1 of this unit.

  Table 1--Summary of Toxicological Doses and Endpoints for Diisopropanolamine 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 (General population     An acute effect was not found in the database therefore an acute dietary
 including infants and children).                           assessment is not necessary.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL = 100 mg/kg/    Chronic RfD = 100    90-day oral toxicity_rat.
                                    day.                  mg/kg/day.          LOAEL = 500 mg/kg/day based on
                                   UFA = 10x...........  cPAD = 1.0 mg/kg/     based on increase in relative and
                                   UFH = 10x...........   day.                 absolute kidney weight.
                                   FQPA SF = 1x........

[[Page 73221]]

 
Incidental oral short-term (1 to   NOAEL = 100 mg/kg/    LOC for MOE = 100..  90-day oral toxicity_rat.
 30 days).                          day.                                      LOAEL = 500 mg/kg/day based on
                                   UFA = 10x...........                        based on increase in relative and
                                   UFH = 10x...........                        absolute kidney weight.
                                   FQPA SF = 1x........
Incidental oral intermediate-term  NOAEL = 100 mg/kg/    LOC for MOE = 100..  90-day oral toxicity_rat.
 (1 to 6 months).                   day.                                      LOAEL = 500 mg/kg/day based on
                                   UFA = 10x...........                        increase in relative and absolute
                                   UFH = 10x...........                        kidney weight.
                                   FQPA SF = 1x........
----------------------------------------------------------------------------------------------------------------
Dermal short- and intermediate-    Dermal exposure was not assessed because no systemic toxicity was identified
 term.                              at the limit dose of 750 mg/kg/day in a dermal toxicity study.
----------------------------------------------------------------------------------------------------------------
Inhalation short-term (1 to 30     oral study NOAEL =    LOC for MOE = 100..  90-day oral toxicity_rat.
 days).                             100 mg/kg/day                             LOAEL = 500 mg/kg/day based on
                                    (inhalation                                based on increase in relative and
                                    absorption rate =                          absolute kidney weight.
                                    100%).
                                   UFA = 10x...........
                                   UFH = 10x...........
                                   FQPA SF = 1x........
----------------------------------------------------------------------------------------------------------------
Inhalation (1 to 6 months).......  oral study NOAEL =    LOC for MOE = 100..  90-day oral toxicity_rat.
                                    100 mg/kg/day                             LOAEL = 500 mg/kg/day based on
                                    (inhalation                                based on increase in relative and
                                    absorption rate =                          absolute kidney weight.
                                    100%).
                                   UFA = 10x...........
                                   UFH = 10x...........
                                   FQPA SF = 1x........
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  Based on the lack of increased incidence of tumor formation compared to
                                    controls in a carcinogenicity study and the lack of mutagenicity,
                                    diisopropanolamine is considered not likely to be carcinogenic.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to diisopropanolamine, EPA considered exposure under the 
proposed exemption from the requirement of a tolerance (40 CFR 180.910 
as an inert ingredient used in pesticide formulations applied to 
growing crops). EPA assessed dietary exposures from diisopropanolamine 
in food as follows:
    Because an acute endpoint of concern was not identified, an acute 
dietary exposure assessment is unnecessary. The chronic dietary 
exposure assessment for this inert ingredient utilizes the Dietary 
Exposure Evaluation Model Food Commodity Intake Database (DEEM-FCID), 
Version 3.16, EPA, which includes food consumption information from the 
U.S. Department of Agriculture's National Health and Nutrition 
Examination Survey, ``What We Eat in America'', (NHANES/WWEIA). This 
dietary survey was conducted from 2003 to 2008. In the absence of 
actual residue data, the inert ingredient evaluation is based on a 
highly conservative model which assumes that the residue level of the 
inert ingredient would be no higher than the highest established 
tolerance for an active ingredient on a given commodity. Implicit in 
this assumption is that there would be similar rates of degradation 
between the active and inert ingredient (if any) and that the 
concentration of inert ingredient in the scenarios leading to these 
highest of tolerances would be no higher than the concentration of the 
active ingredient. The model assumes 100 percent crop treated (PCT) for 
all crops and that every food eaten by a person each day has tolerance-
level residues. 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 diisopropanolamine, a 
conservative drinking water concentration value of 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).
    Diisopropanolamine is used as an inert ingredient in pesticide 
products that could result in short- and intermediate-term residential 
exposure,

[[Page 73222]]

and the Agency has determined that it is appropriate to aggregate 
chronic exposure through food and water with short- and intermediate-
term residential exposures to diisopropanolamine. Possible routes of 
exposure include dermal and/or inhalation exposure to outdoor lawn and 
turf use (i.e. low pressure handwand, hose end sprayer and trigger 
sprayers).
    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 diisopropanolamine to share a common mechanism of 
toxicity with any other substances, and diisopropanolamine does not 
appear to produce a toxic metabolite produced by other substances. For 
the purposes of this tolerance action, therefore, EPA has assumed that 
diisopropanolamine 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

    1. In general. 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 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.
    2. Prenatal and postnatal sensitivity. Fetal susceptibility was not 
observed in developmental studies with rats administered 
diisopropanolamine. Treatment with diisopropanolamine had no effect on 
body weight gain or food consumption during the dosing period, kidney 
or liver weights, gravid uterine weight, number of corpora lutea, 
implantations or resorptions, percent pre- and post-implantation loss, 
mean fetal weight or males or females, fetal sex ratio or the number of 
viable fetuses. There were no statistically significant increases in 
abnormalities (external, visceral or skeletal) in any treatment group 
compared to the control.
    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. That decision is based on the following 
findings:
    i. The toxicity database for diisopropanolamine contains the 
following acceptable studies: Subchronic, developmental, and chronic/
carcinogenicity studies, several mutagenicity studies, and a dermal 
metabolism and absorption study. No repeated dose inhalation toxicity 
study is available in the database, however all inhalation MOEs, which 
are based on the POD from the 90-day oral toxicity study, are greater 
than 15,000. The Agency does not believe that any inhalation study 
would provide a POD so substantially different from the POD in the 90-
day oral toxicity study to result in a risk of concern from inhalation 
exposure; therefore, there is no need to include an additional 
uncertainty factor to account for the lack of inhalation data.
    ii. There is no indication that diisopropanolamine is a neurotoxic 
chemical. Although no neurotoxicity studies were available in the 
database, no clinical signs of neurotoxicity were observed in the 
available subchronic and chronic studies. Therefore, there is no need 
for a developmental neurotoxicity study or additional UFs to account 
for neurotoxicity.
    iii. Based on the discussion above, there is no concern that 
diisopropanolamine results in increased susceptibility in the prenatal 
developmental studies.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100% CT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to diisopropanolamine in drinking water. EPA used 
similarly conservative assumptions to assess postapplication exposure 
of children as well as incidental oral exposure of toddlers. These 
assessments will not underestimate the exposure and risks posed by 
diisopropanolamine.

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. Therefore, 
diisopropanolamine is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
diisopropanolamine from food and water will utilize 14.1% 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). 
Diisopropanolamine is currently used as an inert ingredient in 
pesticide products that are registered for uses 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 diisopropanolamine.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in aggregate MOEs of 2,600 for both 
adult males and females respectively. EPA has concluded the combined 
short-term aggregated food, water, and residential exposure results in 
an aggregate MOE of 680 for children. Children's residential exposure 
includes total exposures associated with contact with treated surfaces 
(hand-to-mouth exposure). Because EPA's level of concern for 
diisopropanolamine is a MOE of 100 or below, these MOEs are not of 
concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic

[[Page 73223]]

exposure to food and water (considered to be a background exposure 
level). Diisopropanolamine is currently used as an inert ingredient in 
pesticide products that are registered for uses 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 
diisopropanolamine.
    Using the exposure assumptions described in this unit for 
intermediate-term exposures, EPA has concluded that the combined 
intermediate-term food, water, and residential exposures result in 
aggregate MOEs of 2,600 for adult males and females. EPA has concluded 
the combined intermediate-term aggregated food, water, and residential 
exposures result in an aggregate MOE of 690 for children. Children's 
residential exposure includes total exposures associated with contact 
with treated surfaces (hand-to-mouth exposure). Because EPA's level of 
concern for diisopropanolamine is a MOE of 100 or below, these MOEs are 
not of concern.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in adequate rodent carcinogenicity study, 
diisopropanolamine 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 diisopropanolamine residues.

V. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since 
the Agency is establishing an exemption from the requirement of a 
tolerance without any numerical limitation.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.910 for diisopropanolamine (CAS Reg. No. 
110-97-4) when used as an inert ingredient (neutralizer or stabilizer) 
in pesticide formulations applied to growing crops or raw agricultural 
commodities after harvest at not more than 10% by weight in pesticide 
formulations.

VII. Statutory and Executive Order Reviews

    This action establishes an exemption from the requirement of 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 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: November 26, 2014.
Susan Lewis,
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
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
Diisopropanolamine (CAS Reg. No. 110-  Not to exceed 10% by weight    Neutralizer or stabilizer.
 97-4).                                 of pesticide formulation.
 
                                                  * * * * * * *
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[[Page 73224]]

[FR Doc. 2014-28955 Filed 12-9-14; 8:45 am]
BILLING CODE 6560-50-P