81 FR 95485 - Methyl Isobutyrate and Isobutyl Isobutyrate; Exemption From the Requirement of a Tolerance
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 81, Issue 249 (December 28, 2016)
Federal Register Volume 81, Issue 249 (December 28, 2016)
| Page Range | 95485-95489 | |
| FR Document | 2016-31215 |
[Federal Register Volume 81, Number 249 (Wednesday, December 28, 2016)] [Rules and Regulations] [Pages 95485-95489] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-31215] [[Page 95485]] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2015-0776 and EPA-HQ-OPP-2015-0831; FRL-9955-82] Methyl Isobutyrate and Isobutyl Isobutyrate; Exemption From the Requirement of a Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This regulation establishes exemptions from the requirement of a tolerance for residues of methyl isobutyrate (CAS Reg. No. 547-63-7) and for residues of isobutyl isobutyrate (CAS Reg. No. 97-85-8) when used as inert ingredients (solvents) applied to growing crops or raw agricultural commodities after harvest. Jeneil Biosurfactant Company 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 methyl isobutyrate and isobutyl isobutyrate when used in accordance with the conditions. DATES: This regulation is effective December 28, 2016. Objections and requests for hearings must be received on or before February 27, 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-2015-0776 and EPA-HQ-OPP-2015- 0831, 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: 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-2015-0776 and EPA-HQ-OPP-2015-0831 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 27, 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-2015-0776 and EPA- HQ-OPP-2015-0831, 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 March 16, 2016 (81 FR 14030) (FRL-9942- 86), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of two pesticide petitions (PP IN-10848 & PP IN-10850) by Jeneil Biosurfactant Company, 400 N. Dekora Woods Blvd., Saukville, WI 53080. The petitions requested that 40 CFR 180.910 be amended by establishing two exemptions from the requirement of a tolerance: One for residues of methyl isobutyrate (CAS Reg. No. 547-63- 7) (PP IN-10848) and one for isobutyl isobutyrate (CAS Reg. No. 97-85- 8) (PP IN-10850), when used as inert ingredients (solvents) applied to growing crops or raw agricultural commodities after harvest. That document referenced a summary of each petition prepared by Jeneil Biosurfactant Company, the petitioner, which are available in the respective dockets (PP IN-10848 in docket ID number EPA-HQ-OPP-2015- 0776 and PP IN-10850 in docket ID number EPA-HQ-OPP-2015-0831), http://www.regulations.gov. Comments were received in response to the notice of filing, requesting the denial of these petitions based only generally on a concern for the use of ``toxic chemicals'' in or on food. Because the commenters did not provide any information upon which to evaluate these specific inert ingredient tolerance exemptions and because EPA has determined that such exemptions would be safe, EPA is not denying the petition as requested. [[Page 95486]] 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 exemption is ``safe.'' Section 408(c)(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 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 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 methyl isobutyrate and isobutyl isobutyrate including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with methyl isobutyrate and isobutyl isobutyrate 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 methyl isobutyrate and isobutyl isobutyrate 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. Methyl isobutyrate and isobutyl isobutyrate are rapidly metabolized through hydrolysis to form an alcohol and carboxylic acid in the body. Many of the supporting data for methyl isobutyrate comes directly from the closely related and similarly metabolized compound isobutyl isobutyrate. Where separate information for methyl isobutyrate and isobutyl isobutyrate is available, the studies will be presented along with information for their common metabolite isobutanol. An LD 50 value of 16,000 milligrams/kilogram body weight (mg/kg bw) was determined in rats for methyl isobutyrate. The LC50 of methyl isobutyrate was 25.5 milligrams per Liter (mg/L) in mice. The acute oral LD50 for isobutyl isobutyrate value in rats and mice was >6,400 mg/kg. The acute inhalation LC50 (6 hour exposure duration) was between 3.88 and 31.94 mg/L isobutyl isobutyrate in rats. The dermal LD50 value for isobutyl isobutyrate in guinea pigs was >8,550 mg/kg. No repeat-dose studies of methyl isobutyrate were identified in a search of the toxicological literature. In an 18-week oral gavage study in rats with isobutyl isobutyrate, there were no treatment related effects in hematology, clinical chemistry parameters, urinalysis, histological examination, behavior, appearance, body weight, or food/ water consumption. The NOAEL was 1,000 mg/kg/day; the highest dose tested. In a 90-day oral toxicity study in rats with isobutanol, treatment related effects were seen only at 1,000 mg/kg bw/day, and included hypoactivity, which was significant during week one and decreased markedly after week 4, and lower body weight gain (18% below that of control rats) in males during week one. The NOAEL was 316 mg/kg bw/day. In a 90-day study toxicity study in rats exposed to isobutanol in drinking water, no effects on body weight, food/water consumption, and clinical signs of toxicity and organ weights (livers, kidneys, adrenal glands, and testes) were observed at doses up to 1,450 mg/kg/day. The NOAEL for isobutanol was 1,450 mg/kg/day. In a 90-day isobutanol inhalation study, no differences were found in body weight, food consumption, ophthalmoscopic examination, clinical observation, clinical chemistry, neurobehavioral observations, organ weights, gross pathology, and histopathology. The NOAEL for repeat-dose effects including neurotoxicity was 2,500 ppm. In two prenatal developmental toxicity studies via inhalation, female rats and Himalayan rabbits were exposed to vapor of isobutanol. In rats, no mortality or significant differences in clinical signs, body weight development, or gross pathology between controls and treated groups and no effects on development were noted. The maternal and developmental rat NOAELs were 3,030 ppm. In rabbits, no mortality or significant differences in clinical signs, body weight development, or gross pathology between controls and treated groups and no effects on development were noted. The maternal no observed adverse effect level (NOAEL) for rabbits was 758 ppm. Fetuses exhibited no signs of developmental changes in response to isobutanol. Therefore, the developmental NOAEL was 3,030 ppm, the highest dose. In a 2-generation reproduction study in rats with isobutanol via inhalation, no exposure-related effects were observed on F0 and F1 parental survival or on F0 and F1 reproductive performance, body weights, food [[Page 95487]] consumption and food efficiency in males or females. The NOAEL for isobutanol for parental systemic, reproductive and neonatal toxicity is 2,500 ppm (7,380 mg/m\3\ the maximum concentrations exposed). There were no adequate studies on the carcinogenic potential of methyl isobutyrate or isobutanol isobutyrate. Methyl isobutyrate did not significantly induce chromosome loss in mitotically growing Saccharomyces cerevisiae. The structurally similar isobutyl isobutyrate did not induce reverse mutations at concentrations as high as 5,000 microgram/milliliter (ug/mL). An evaluation of the structure of methyl isobutyrate for alerts to genotoxicity yields no identifiable structures of concern. Based on negative results in genotoxicity assays and an extensive history of exposure to isobutyl isobutyrate, carcinogenic potential of this compound is likely to be low. Methyl isobutyrate was not genotoxic in one study and it does not contain reactive substructures of concern and isobutyl isobutyrate was also negative in genotoxic assays and in extensive exposure history; therefore the carcinogenic potential of both compounds is low. Metabolism of aliphatic esters such as methyl isobutyrate and isobutyl isobutyrate proceeds rapidly through hydrolysis to form an alcohol and carboxylic acid. These are reactions of the carboxylesterases or esterases, which predominate in hepatocytes but are present in most tissues throughout the body, including small intestine, colon, kidney, trachea and lung. Hydrolysis of methyl isobutyrate is extensive and will form methanol and isobutyric acid. Isobutyric acid is metabolized to propionic acid which, in turn, is converted to succinic acid and ultimately to glucose and glycogen. Methanol is oxidized and excreted ultimately as CO2 and water. In male rats injected intravenously with isobutyl isobutyrate, the parent compound decreased rapidly in blood and was undetected after 166 seconds. The half-life was calculated at 11.1 seconds. Isobutanol and isobutyric acid levels increased rapidly, with the acid consistently higher than the alcohol, suggesting that the former is a metabolic product of the alcohol in addition to the parent compound. Isobutyric acid will be conjugated and excreted or will undergo [beta]- oxidation in the fatty acid metabolic pathway. 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. EPA has not identified any toxicological points of departure for assessing methyl isobutyrate and isobutyl isobutyrate. On the basis of the metabolism of as methyl isobutyrate and isobutyl isobutyrate proceeding rapidly through hydrolysis to form an alcohol and carboxylic acid and ultimately to glucose and glycogen, low acute toxicity for animals via the dermal, inhalation, and oral routes of exposure, and low toxicity of the metabolite isobutyl alcohol, no adverse effect is expected from methyl isobutyrate and isobutyl isobutyrate as a result of exposure by any route. C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to methyl isobutyrate and isobutyl isobutyrate, EPA considered exposure under the proposed exemption from the requirement of a tolerance. EPA assessed dietary exposures from methyl isobutyrate and isobutyl isobutyrate in food as follows: Acute and chronic dietary assessments take into account exposure estimates from dietary consumption of food and drinking water. Because no adverse effects attributable to a single or repeat exposures to methyl isobutyrate and isobutyl isobutyrate were seen in the toxicity databases, quantitative dietary risk assessments are not appropriate. Due to expected use of methyl isobutyrate and isobutyl isobutyrate in pesticide formulations applied to growing crops and raw agricultural commodities after harvest, it is reasonable to expect that there will be some exposure to these substances from their use in pesticide products. In addition, FDA has approved the use of methyl isobutyrate and isobutyl isobutyrate as synthetic flavoring substances in food for direct human consumption (21 CFR 172.515), so there is expected to be additional dietary exposure to these substances from non-pesticidal sources. 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 methyl isobutyrate and isobutyl isobutyrate, a conservative drinking water concentration value would normally be included in dietary exposure screening level model. However, because no adverse effects attributable to a single or repeat exposures to methyl isobutyrate and isobutyl isobutyrate were seen in the toxicity databases, quantitative dietary risk assessments are not appropriate. 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). It is possible that methyl isobutyrate or isobutyl may be used as an inert ingredient in pesticide products that may result in residential exposures, although no residential uses are currently proposed. 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 or exemption from 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.'' Because methyl isobutyrate and isobutyl isobutyrate do not have a toxic mode of action or a mechanism of toxicity, this provision does not apply. 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 [[Page 95488]] 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. Because methyl isobutyrate and isobutyl isobutyrate do not have threshold effects and because of the lack of safety factors needed for this qualitative assessment, this provision does not apply to the assessment of methyl isobutyrate and isobutyl isobutyrate. E. Aggregate Risks and Determination of Safety Determination of safety section. Based on the lack of any endpoints of concern, 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 methyl isobutyrate and isobutyl isobutyrate 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, exemptions from the requirement of a tolerance are established under 40 CFR 180.910 for methyl isobutyrate (CAS Reg. No. 547-63-7) and isobutyl isobutyrate (CAS Reg. No. 97-85-8) when used as inert ingredients (solvents) in pesticide formulations applied to growing crops or raw agricultural commodities after harvest. VII. Statutory and Executive Order Reviews This action establishes exemptions 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 exemptions 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: December 15, 2016. Daniel J. Rosenblatt, Acting 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 ingredients ``Isobutyl isobutyrate (CAS Reg. No. 97-85-8)''; and ``Methyl isobutyrate (CAS Reg. No. 547-63-7)'' 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 ------------------------------------------------------------------------ * * * * * * * Isobutyl isobutyrate (CAS Reg. None............... Solvent No. 97-85-8). * * * * * * * Methyl isobutyrate (CAS Reg. No. None............... Solvent 547-63-7). * * * * * * * ------------------------------------------------------------------------ [[Page 95489]] [FR Doc. 2016-31215 Filed 12-27-16; 8:45 am] BILLING CODE 6560-50-P
![Federal Register / Vol. 81, No. 249 / Wednesday, December 28, 2016 / Rules and Regulations 95485
ENVIRONMENTAL PROTECTION Pennsylvania Ave. NW., Washington, notice. Submit the non-CBI copy of your
AGENCY DC 20460–0001; main telephone objection or hearing request, identified
number: (703) 305–7090; email address: by docket ID number EPA–HQ–OPP–
40 CFR Part 180 RDFRNotices@epa.gov. 2015–0776 and EPA–HQ–OPP–2015–
[EPA–HQ–OPP–2015–0776 and EPA–HQ– SUPPLEMENTARY INFORMATION: 0831, by one of the following methods:
OPP–2015–0831; FRL–9955–82]
I. General Information • Federal eRulemaking Portal: http://
www.regulations.gov. Follow the online
Methyl Isobutyrate and Isobutyl A. Does this action apply to me? instructions for submitting comments.
Isobutyrate; Exemption From the Do not submit electronically any
You may be potentially affected by
Requirement of a Tolerance information you consider to be CBI or
this action if you are an agricultural
AGENCY: Environmental Protection producer, food manufacturer, or other information whose disclosure is
Agency (EPA). pesticide manufacturer. The following restricted by statute.
ACTION: Final rule. list of North American Industrial • Mail: OPP Docket, Environmental
Classification System (NAICS) codes is Protection Agency Docket Center (EPA/
SUMMARY: This regulation establishes not intended to be exhaustive, but rather DC), (28221T), 1200 Pennsylvania Ave.
exemptions from the requirement of a provides a guide to help readers NW., Washington, DC 20460–0001.
tolerance for residues of methyl determine whether this document • Hand Delivery: To make special
isobutyrate (CAS Reg. No. 547–63–7) applies to them. Potentially affected arrangements for hand delivery or
and for residues of isobutyl isobutyrate entities may include: delivery of boxed information, please
(CAS Reg. No. 97–85–8) when used as • Crop production (NAICS code 111). follow the instructions at http://
inert ingredients (solvents) applied to • Animal production (NAICS code www.epa.gov/dockets/contacts.html.
growing crops or raw agricultural 112).
commodities after harvest. Jeneil • Food manufacturing (NAICS code Additional instructions on
Biosurfactant Company submitted a 311). commenting or visiting the docket,
petition to EPA under the Federal Food, • Pesticide manufacturing (NAICS along with more information about
Drug, and Cosmetic Act (FFDCA), code 32532). dockets generally, is available at http://
requesting establishment of an www.epa.gov/dockets.
B. How can I get electronic access to
exemption from the requirement of a II. Petition for Exemption
other related information?
tolerance. This regulation eliminates the
need to establish a maximum You may access a frequently updated In the Federal Register of March 16,
permissible level for residues of methyl electronic version of 40 CFR part 180 2016 (81 FR 14030) (FRL–9942–86),
isobutyrate and isobutyl isobutyrate through the Government Printing EPA issued a document pursuant to
when used in accordance with the Office’s e-CFR site at http:// FFDCA section 408, 21 U.S.C. 346a,
conditions. www.ecfr.gov/cgi-bin/text- announcing the filing of two pesticide
idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ petitions (PP IN–10848 & PP IN–10850)
DATES: This regulation is effective by Jeneil Biosurfactant Company, 400 N.
40tab_02.tpl.
December 28, 2016. Objections and Dekora Woods Blvd., Saukville, WI
requests for hearings must be received C. How can I file an objection or hearing 53080. The petitions requested that 40
on or before February 27, 2017, and request? CFR 180.910 be amended by
must be filed in accordance with the Under FFDCA section 408(g), 21 establishing two exemptions from the
instructions provided in 40 CFR part U.S.C. 346a, any person may file an requirement of a tolerance: One for
178 (see also Unit I.C. of the objection to any aspect of this regulation residues of methyl isobutyrate (CAS
SUPPLEMENTARY INFORMATION). and may also request a hearing on those Reg. No. 547–63–7) (PP IN–10848) and
ADDRESSES: The docket for this action, objections. You must file your objection one for isobutyl isobutyrate (CAS Reg.
identified by docket identification (ID) or request a hearing on this regulation No. 97–85–8) (PP IN–10850), when used
number EPA–HQ–OPP–2015–0776 and in accordance with the instructions as inert ingredients (solvents) applied to
EPA–HQ–OPP–2015–0831, is available provided in 40 CFR part 178. To ensure growing crops or raw agricultural
at http://www.regulations.gov or at the proper receipt by EPA, you must commodities after harvest. That
Office of Pesticide Programs Regulatory identify docket ID number EPA–HQ– document referenced a summary of each
Public Docket (OPP Docket) in the OPP–2015–0776 and EPA–HQ–OPP– petition prepared by Jeneil Biosurfactant
Environmental Protection Agency 2015–0831 in the subject line on the Company, the petitioner, which are
Docket Center (EPA/DC), West William first page of your submission. All available in the respective dockets (PP
Jefferson Clinton Bldg., Rm. 3334, 1301 objections and requests for a hearing IN–10848 in docket ID number EPA–
Constitution Ave. NW., Washington, DC must be in writing, and must be HQ–OPP–2015–0776 and PP IN–10850
20460–0001. The Public Reading Room received by the Hearing Clerk on or in docket ID number EPA–HQ–OPP–
is open from 8:30 a.m. to 4:30 p.m., before February 27, 2017. Addresses for 2015–0831), http://www.regulations.gov.
Monday through Friday, excluding legal mail and hand delivery of objections Comments were received in response to
holidays. The telephone number for the and hearing requests are provided in 40 the notice of filing, requesting the denial
Public Reading Room is (202) 566–1744, CFR 178.25(b). of these petitions based only generally
and the telephone number for the OPP In addition to filing an objection or on a concern for the use of ‘‘toxic
Docket is (703) 305–5805. Please review hearing request with the Hearing Clerk chemicals’’ in or on food. Because the
sradovich on DSK3GMQ082PROD with RULES
the visitor instructions and additional as described in 40 CFR part 178, please commenters did not provide any
information about the docket available submit a copy of the filing (excluding information upon which to evaluate
at http://www.epa.gov/dockets. any Confidential Business Information these specific inert ingredient tolerance
FOR FURTHER INFORMATION CONTACT: (CBI)) for inclusion in the public docket. exemptions and because EPA has
Michael Goodis, Registration Division Information not marked confidential determined that such exemptions would
(7505P), Office of Pesticide Programs, pursuant to 40 CFR part 2 may be be safe, EPA is not denying the petition
Environmental Protection Agency, 1200 disclosed publicly by EPA without prior as requested.
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![95488 Federal Register / Vol. 81, No. 249 / Wednesday, December 28, 2016 / Rules and Regulations
prenatal and postnatal toxicity and the Agency. The Office of Management and with Indian Tribal Governments’’ (65 FR
completeness of the database on toxicity Budget (OMB) has exempted these types 67249, November 9, 2000) do not apply
and exposure unless EPA determines of actions from review under Executive to this action. In addition, this action
based on reliable data that a different Order 12866, entitled ‘‘Regulatory does not impose any enforceable duty or
margin of safety will be safe for infants Planning and Review’’ (58 FR 51735, contain any unfunded mandate as
and children. This additional margin of October 4, 1993). Because this action described under Title II of the Unfunded
safety is commonly referred to as the has been exempted from review under Mandates Reform Act (UMRA) (2 U.S.C.
FQPA Safety Factor (SF). In applying Executive Order 12866, this action is 1501 et seq.).
this provision, EPA either retains the not subject to Executive Order 13211, This action does not involve any
default value of 10X, or uses a different entitled ‘‘Actions Concerning technical standards that would require
additional safety factor when reliable Regulations That Significantly Affect Agency consideration of voluntary
data available to EPA support the choice Energy Supply, Distribution, or Use’’ (66 consensus standards pursuant to section
of a different factor. FR 28355, May 22, 2001) or Executive 12(d) of the National Technology
Because methyl isobutyrate and Order 13045, entitled ‘‘Protection of Transfer and Advancement Act
isobutyl isobutyrate do not have Children from Environmental Health (NTTAA) (15 U.S.C. 272 note).
threshold effects and because of the lack Risks and Safety Risks’’ (62 FR 19885,
of safety factors needed for this April 23, 1997). This action does not VIII. Congressional Review Act
qualitative assessment, this provision contain any information collections Pursuant to the Congressional Review
does not apply to the assessment of subject to OMB approval under the Act (5 U.S.C. 801 et seq.), EPA will
methyl isobutyrate and isobutyl Paperwork Reduction Act (PRA) (44 submit a report containing this rule and
isobutyrate. U.S.C. 3501 et seq.), nor does it require other required information to the U.S.
any special considerations under Senate, the U.S. House of
E. Aggregate Risks and Determination of Executive Order 12898, entitled
Safety Representatives, and the Comptroller
‘‘Federal Actions to Address
General of the United States prior to
Determination of safety section. Based Environmental Justice in Minority
publication of the rule in the Federal
on the lack of any endpoints of concern, Populations and Low-Income
Register. This action is not a ‘‘major
EPA concludes that there is a reasonable Populations’’ (59 FR 7629, February 16,
rule’’ as defined by 5 U.S.C. 804(2).
certainty that no harm will result to the 1994).
general population or to infants and Since tolerances and exemptions that List of Subjects in 40 CFR Part 180
children from aggregate exposure to are established on the basis of a petition
under FFDCA section 408(d), such as Environmental protection,
methyl isobutyrate and isobutyl
the exemptions in this final rule, do not Administrative practice and procedure,
isobutyrate residues.
require the issuance of a proposed rule, Agricultural commodities, Pesticides
V. Analytical Enforcement Methodology the requirements of the Regulatory and pests, Reporting and recordkeeping
An analytical method is not required Flexibility Act (RFA) (5 U.S.C. 601 et requirements.
for enforcement purposes since the seq.), do not apply. Dated: December 15, 2016.
Agency is establishing an exemption This action directly regulates growers, Daniel J. Rosenblatt,
from the requirement of a tolerance food processors, food handlers, and food Acting Director, Registration Division, Office
without any numerical limitation. retailers, not States or tribes, nor does of Pesticide Programs.
this action alter the relationships or
VI. Conclusions distribution of power and Therefore, 40 CFR chapter I is
Therefore, exemptions from the responsibilities established by Congress amended as follows:
requirement of a tolerance are in the preemption provisions of FFDCA
established under 40 CFR 180.910 for section 408(n)(4). As such, the Agency PART 180—[AMENDED]
methyl isobutyrate (CAS Reg. No. 547– has determined that this action will not
63–7) and isobutyl isobutyrate (CAS have a substantial direct effect on States ■ 1. The authority citation for part 180
Reg. No. 97–85–8) when used as inert or tribal governments, on the continues to read as follows:
ingredients (solvents) in pesticide relationship between the national Authority: 21 U.S.C. 321(q), 346a and 371.
formulations applied to growing crops government and the States or tribal ■ 2. In § 180.910, add alphabetically the
or raw agricultural commodities after governments, or on the distribution of inert ingredients ‘‘Isobutyl isobutyrate
harvest. power and responsibilities among the (CAS Reg. No. 97–85–8)’’; and ‘‘Methyl
various levels of government or between isobutyrate (CAS Reg. No. 547–63–7)’’ to
VII. Statutory and Executive Order the Federal Government and Indian
Reviews the table to read as follows:
tribes. Thus, the Agency has determined
This action establishes exemptions that Executive Order 13132, entitled § 180.910 Inert ingredients used pre- and
from the requirement of a tolerance ‘‘Federalism’’ (64 FR 43255, August 10, post-harvest; exemptions from the
under FFDCA section 408(d) in 1999) and Executive Order 13175, requirement of a tolerance.
response to a petition submitted to the entitled ‘‘Consultation and Coordination * * * * *
Inert ingredients Limits Uses
sradovich on DSK3GMQ082PROD with RULES
* * * * * * *
Isobutyl isobutyrate (CAS Reg. No. 97–85–8) .............................................................................................. None ................................ Solvent
* * * * * * *
Methyl isobutyrate (CAS Reg. No. 547–63–7) .............................................................................................. None ................................ Solvent
* * * * * * *
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![Federal Register / Vol. 81, No. 249 / Wednesday, December 28, 2016 / Rules and Regulations 95489
[FR Doc. 2016–31215 Filed 12–27–16; 8:45 am] compliance with standards in another monetary penalties administered by the
BILLING CODE 6560–50–P year or purchased from another Agency, including those prescribed by
manufacturer. If a manufacturer does the CAFE program. In accordance with
not have credits to apply, and does not the Act and OMB guidance, the updated
DEPARTMENT OF TRANSPORTATION apply sufficient fuel economy- penalty rate increased from $5.50 per
improving technologies to their vehicles tenth of a mile per gallon (mpg) to $14
National Highway Traffic Safety to meet their fleet-wide standards, then per tenth of an mpg.5 NHTSA stated in
Administration that manufacturer is liable for civil implementation guidance that it issued
penalties.3 following the IFR that the Agency
49 CFR Part 578 Congress has prescribed the formula intended to apply the $14 rate to any
for calculating a civil penalty for penalties assessed on and after August
[Docket No. NHTSA–2016–0136]
violation of a CAFE standard. That 4, 2016, beginning with penalties
RIN 2127–AL82 formula multiplies the penalty rate applicable to violations for MY 2015,
times the number of tenths-of-a-mile- and also applying to any violations from
Civil Penalties per-gallon by which a non-compliant prior model years that resulted from
AGENCY: National Highway Traffic fleet falls short of an applicable CAFE recalculation of a manufacturer’s
Safety Administration (NHTSA), standard, times the number of vehicles previous CAFE levels.6
Department of Transportation (DOT). in that non-compliant fleet.4 For many
II. Industry Petition for
ACTION: Final rule; response to petition
years, the penalty rate has been $5.50
Reconsideration
for reconsideration; response to petition per tenth-of-a-mile-per-gallon. As an
illustration, assume that Manufacturer A The Auto Alliance and Global
for rulemaking. Automakers jointly petitioned NHTSA
produced 1,000,000 light trucks in
SUMMARY: On July 5, 2016, NHTSA model year 2010. Assume further that A for reconsideration of the interim final
published an interim final rule updating has a light truck standard of 20 mpg for rule with regard to the inflation
the maximum civil penalty amounts for MY 2010, and an achieved light truck adjustment for CAFE non-compliance
violations of statutes and regulations average fuel economy level of 19.7 mpg penalties (hereafter, the Alliance and
administered by NHTSA, pursuant to in that model year. If A has no credits Global petition will be referred to as the
the Federal Civil Penalties Inflation to apply, then A’s assessed civil penalty ‘‘Industry Petition’’) on August 1, 2016.
Adjustment Act Improvements Act of under this historical penalty rate would The Industry Petition asked that NHTSA
2015. This decision responds to a be: not apply the penalty increase to non-
compliances associated with ‘‘model
petition for partial reconsideration of $5.50 (penalty rate) × 3 (tenths of an
years that have already been completed
that interim final rule. After carefully mpg) × 1,000,000 (vehicles in
considering the issues raised, the or for which a company’s compliance
Manufacturer A’s light truck fleet) =
Agency grants some aspects of the plan has already been set.’’ Specifically,
$16,500,000 due for A’s light truck
petition, and denies other aspects. This the Industry Petition stated that:
fleet for MY 2010.
decision amends the relevant regulatory To date, few manufacturers have Our most significant concern with the IFR
text accordingly. This decision also is that it would apply retroactively to the
actually paid civil penalties, and the 2014 and 2015 Model Years (which have
responds to a petition for rulemaking on amounts of CAFE penalties paid
a similar topic. been completed for all manufacturers but for
generally have been relatively low. which the compliance files are not all
DATES: Effective date: This rule is Additionally, since the introduction of closed), to the 2016 Model Year (which is
effective January 27, 2017. credit trading and transfers for MY 2011 complete for many manufacturers) and to the
FOR FURTHER INFORMATION CONTACT: Ms. and after, many manufacturers have 2017 and 2018 Model Years (for which
Rebecca Yoon, Office of the Chief taken advantage of those flexibilities manufacturers have already set compliance
Counsel, NHTSA, telephone (202) 366– rather than paying civil penalties for plans based on guidance from NHTSA,
2992, facsimile (202) 366–3820, 1200 including the [historical penalty amounts of
non-compliance. $5.50 per tenth of an mpg]). Applying the
New Jersey Avenue SE., Washington, The Federal Civil Penalties Inflation increased civil penalties in this manner is
DC 20590. Adjustment Act Improvements Act profoundly unfair to manufacturers, does not
SUPPLEMENTARY INFORMATION: (November 2, 2015) (the ‘‘Act’’) improve the effectiveness of this penalty, and
prescribed an inflation adjustment for does nothing to further the policies
I. Background on CAFE Penalties and many civil monetary penalties, underlying the CAFE statute.
Interim Final Rule including CAFE’s civil penalty rate. In Industry Petition at 3.
The National Highway Traffic Safety that Act, Congress generally required In the alternative, the Industry
Administration (NHTSA) administers Federal agencies that administer civil Petition requested that if NHTSA
Corporate Average Fuel Economy monetary penalties to make an initial decided to apply the penalty increase to
(CAFE) standards under 49 U.S.C. 32901 ‘‘catch-up’’ adjustment for inflation MYs 2014–2018, the Agency should
et seq. Vehicle manufacturers that through an interim final rule by July 1, recalculate the adjusted penalty rate
produce passenger cars and light trucks 2016, and then to make subsequent
for sale in the United States are subject annual adjustments for inflation (see 5 NHTSA’s explanation of its process, including
to these standards,1 and are subject to Pub. L. 114–74, Sec. 701). NHTSA reliance on OMB guidance for calculating the initial
civil penalties for failure to meet the developed an interim final rule (IFR) adjustment required by the Act, is set forth in the
interim final rule at 81 FR 43524–26 (Jul. 5, 2016).
standards.2 Manufacturers generally implementing the Agency’s
sradovich on DSK3GMQ082PROD with RULES
The interim final rule also discusses the ‘‘rounding
meet the standards by applying responsibilities under that Act, and that rule’’ under the prior version of the Federal Civil
technology to their vehicles to improve IFR published in the Federal Register Penalties Inflation Adjustment Act, which
their fleet-wide fuel economy, but may on July 5, 2016. The NHTSA IFR prevented NHTSA from raising the $5.50 rate after
1997.
also apply credits earned from over- included adjustments for all civil 6 Memorandum, ‘‘Implementation of the Federal
Civil Penalties Inflation Adjustment Act
1 49 U.S.C. 32911(b). 3 Civil penalties are remitted to the U.S. Treasury. Improvement Act of 2015 for the Corporate Average
2 49 U.S.C. 32912(b). 4 49 U.S.C. 32912(b). Fuel Economy (CAFE) Program,’’ July 18, 2016.
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Document Created: 2016-12-28 02:16:57
Document Modified: 2016-12-28 02:16:57
| 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 December 28, 2016. Objections and requests for hearings must be received on or before February 27, 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 | 81 FR 95485 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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