Federal Register/Vol. 79, No. 143/Friday, July 25, 2014/Proposed

43350 Federal Register / Vol. 79, No. 143 / Friday, July 25, 2014 / Proposed Rules

ENVIRONMENTAL PROTECTION Programs Branch (AR–18J), DATES: Comments must be received on AGENCY Environmental Protection Agency, or before September 23, 2014. Region 5, 77 West Jackson Boulevard, ADDRESSES: Submit your comments, 40 CFR Part 52 Chicago, Illinois 60604, (312) 886–6031, identified by docket identification (ID) [EPA–R05–OAR–2013–0214; FRL–9914–25– [email protected]. number EPA–HQ–OPP–2013–0821, by Region 5] SUPPLEMENTARY INFORMATION: In the one of the following methods: Final Rules section of this Federal • Federal eRulemaking Portal: http:// Approval and Promulgation of Air Register, EPA is approving the State’s www.regulations.gov. Follow the online Quality Implementation Plans; Indiana; SIP submittal as a direct final rule instructions for submitting comments. Solvent Degreasing Operations Rule without prior proposal because the Do not submit electronically any information you consider to be AGENCY: Environmental Protection Agency views this as a noncontroversial Confidential Business Information (CBI) Agency (EPA). submittal and anticipates no adverse comments. A detailed rationale for the or other information whose disclosure is ACTION: Proposed rule. approval is set forth in the direct final restricted by statute. • Mail: OPP Docket, Environmental SUMMARY: The Environmental Protection rule. If no adverse comments are Protection Agency Docket Center (EPA/ Agency (EPA) is proposing to approve a received in response to this rule, no DC), (28221T), 1200 Pennsylvania Ave. request submitted by the Indiana further activity is contemplated. If EPA NW., Washington, DC 20460–0001. Department of Environmental receives adverse comments, the direct • Hand Delivery: To make special Management (IDEM) on March 14, 2013, final rule will be withdrawn and all arrangements for hand delivery or to revise the Indiana state public comments received will be delivery of boxed information, please implementation plan (SIP) solvent addressed in a subsequent final rule follow the instructions at http:// degreasing operation rule. The state’s based on this proposed rule. EPA will not institute a second comment period. www.epa.gov/dockets/contacts.htm. submission seeks to extend vapor Additional instructions on pressure limitations (previously Any parties interested in commenting on this action should do so at this time. commenting or visiting the docket, applying to four counties) state-wide, along with more information about add certain exemptions and streamline Please note that if EPA receives adverse comment on an amendment, paragraph, dockets generally, is available at the rule by repealing and consolidating http://www.epa.gov/dockets. certain provisions. There is also a or section of this rule, and if that FOR FURTHER INFORMATION CONTACT: revised definition for ‘‘cold cleaner provision may be severed from the Lois degreaser.’’ remainder of the rule, EPA may adopt Rossi, Registration Division (7505P), as final those provisions of the rule that Office of Pesticide Programs, DATES: Comments must be received on are not the subject of an adverse Environmental Protection Agency, 1200 or before August 25, 2014. comment. For additional information, Pennsylvania Ave. NW., Washington, ADDRESSES: Submit your comments, see the direct final rule which is located DC 20460–0001; telephone number: identified by Docket ID No. EPA–R05– in the Rules section of this Federal (703) 305–7090; email address: OAR–2013–0214 by one of the following Register. [email protected]. methods: SUPPLEMENTARY INFORMATION: 1. www.regulations.gov: Follow the Dated: July 14, 2014. on-line instructions for submitting Susan Hedman, I. General Information comments. Regional Administrator, Region 5. A. Does this action apply to me? 2. Email: [email protected]. [FR Doc. 2014–17475 Filed 7–24–14; 8:45 am] You may be potentially affected by 3. Fax: (312) 692–2450. BILLING CODE 6560–50–P 4. Mail: Pamela Blakley, Chief, this action if you are an agricultural Control Strategies Section (AR–18J), producer, food manufacturer, or U.S. Environmental Protection Agency, ENVIRONMENTAL PROTECTION pesticide manufacturer. The following 77 West Jackson Boulevard, Chicago, AGENCY list of North American Industrial Illinois 60604. Classification System (NAICS) codes is 5. Hand Delivery: Pamela Blakley, 40 CFR Part 180 not intended to be exhaustive, but rather Chief, Control Strategies Section (AR– provides a guide to help readers 18J), U.S. Environmental Protection [EPA–HQ–OPP–2013–0821; FRL–9910–53] determine whether this document Agency, 77 West Jackson Boulevard, applies to them. Potentially affected Chicago, Illinois 60604. Such deliveries Fragrance Components; Proposed entities may include: Exemption From the Requirement of a • Crop production (NAICS code 111). are only accepted during the Regional • Office normal hours of operation, and Tolerance Animal production (NAICS code special arrangements should be made 112). AGENCY: Environmental Protection • Food manufacturing (NAICS code for deliveries of boxed information. The Agency (EPA). 311). Regional Office official hours of • Pesticide manufacturing (NAICS business are Monday through Friday, ACTION: Proposed rule. code 32532). 8:30 a.m. to 4:30 p.m., excluding SUMMARY: This document proposes to Federal holidays. establishes an exemption from the B. What should I consider as I prepare Please see the direct final rule which requirement of a tolerance for residues my comments for EPA? is located in the Rules section of this of various fragrance component 1. Submitting CBI. Do not submit this Federal Register for detailed substances (when used as inert information to EPA through instructions on how to submit ingredients) in antimicrobial pesticide www.regulations.gov or email. Clearly comments. formulations for use on food contact mark the part or all of the information FOR FURTHER INFORMATION CONTACT: surfaces in public eating places, dairy that you claim to be CBI. For CBI Charles Hatten, Environmental processing equipment, and food information in a disk or CD–ROM that Engineer, Control Strategies Section, Air processing equipment and utensils. you mail to EPA, mark the outside of the

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disk or CD–ROM as CBI and then 452–79–1), (E)–geraniol (CAS Reg. No. chemical residue in establishing a identify electronically within the disk or 106–24–1), (E)-geraniol acetate (CAS tolerance and to ‘‘ensure that there is a CD–ROM the specific information that Reg. No. 105–87–3), heptanal (CAS Reg. reasonable certainty that no harm will is claimed as CBI. In addition to one No. 111–71–7), heptanoic acid (CAS result to infants and children from complete version of the comment that Reg. No. 111–14–8), heptyl alcohol aggregate exposure to the pesticide includes information claimed as CBI, a (CAS Reg. No. 111–70–6), hexanal (CAS chemical residue. . . .’’ copy of the comment that does not Reg. No. 66–25–1), hexanoic acid (CAS EPA performs a number of analyses to contain the information claimed as CBI Reg. No. 142–62–1), (Z)-3-hexenol (CAS determine the risks from aggregate must be submitted for inclusion in the Reg. No. 928–96–1), (Z)-3-hexenol exposure to pesticide residues. For public docket. Information so marked acetate (CAS Reg. No. 3681–71–8), hexyl further discussion of the regulatory will not be disclosed except in acetate (CAS Reg. No. 142–92–7), hexyl requirements of FFDCA section 408 and accordance with procedures set forth in alcohol (CAS Reg. No. 111–27–3), lauric a complete description of the risk 40 CFR part 2. acid (CAS Reg. No. 143–07–7), lauric assessment process, see http:// 2. Tips for preparing your comments. aldehyde (CAS Reg. No. 112–54–9), www.epa.gov/fedrgstr/EPA-PEST/1997/ When submitting comments, remember lauryl alcohol (CAS Reg. No. 112–53–8), November/Day-26/p30948.htm. to: methyl-a-ionone (CAS Reg. No. 127–42– Consistent with FFDCA section i. Identify the document by docket ID 4), 3-methyl-2-butenyl acetate (CAS Reg. 408(b)(2)(D), EPA has reviewed the number and other identifying No. 1191–16–8), 2-methylundecanal available scientific data and other information (subject heading, Federal (CAS Reg. No. 110–41–8), relevant information in support of this Register date and page number). myristaldehyde (CAS Reg. No. 124–25– action. EPA has sufficient data to assess ii. Follow directions. The Agency may 4), myristic acid (CAS Reg. No. 544–63– the hazards of and to make a ask you to respond to specific questions 8), neryl acetate (CAS Reg. No. 141–12– determination on aggregate exposure, or organize comments by referencing a 8), n-hexanol (CAS Reg. No. 111–27–3), consistent with FFDCA section Code of Federal Regulations (CFR) part nonanal (CAS Reg. No. 124–19–6), 408(b)(2), for an exemption from or section number. nonanoic acid (CAS Reg. No. 112–05–0), tolerance for residues of fragrance iii. Explain why you agree or disagree; nonyl alcohol (CAS Reg. No. 143–08–8), components listed in Unit II. used as suggest alternatives and substitute octanal (CAS Reg. No. 124–13–0), inert ingredients in antimicrobial language for your requested changes. octanoic acid (CAS Reg. No. 124–07–2), pesticide formulations for use on food iv. Describe any assumptions and 1–octanol (CAS Reg. No. 111–87–5), contact surfaces in public eating places, provide any technical information and/ palmitic acid (CAS Reg. No. 57–10–3), dairy processing equipment, and food or data that you used. propionic acid (CAS Reg. No. 79–09–4), processing equipment and utensils at v. If you estimate potential costs or stearic acid (CAS Reg. No. 57–11–4), 2- end-use concentrations not to exceed burdens, explain how you arrived at tridecanal (CAS Reg. No. 7774–82–5), 100 ppm. EPA’s assessment of your estimate in sufficient detail to 3,5,5-trimethylhexanal (CAS Reg. No. exposures and risks associated with allow for it to be reproduced. 5435–64–3), undecanal (CAS Reg. No. establishing the exemptions from vi. Provide specific examples to 112–44–7), undecyl alcohol (CAS Reg. illustrate your concerns and suggest No. 112–42–5), valeraldehyde (CAS Reg. tolerance for the fragrance components alternatives. No. 110–62–3), and valeric acid (CAS listed in Unit II. follows: vii. Explain your views as clearly as Reg. No. 109–52–4) when used as A. Toxicological Profile possible, avoiding the use of profanity fragrance components (i.e., inert or personal threats. ingredients) in antimicrobial pesticide In the case of the fragrance viii. Make sure to submit your formulations for use on food contact components listed in Unit II. above, comments by the comment period surfaces in public eating places, dairy each of these substances has been deadline identified. processing equipment, and food approved for use as a synthetic flavoring substance in food under 21 CFR 172.515 II. This Proposal processing equipment and utensils at end–use concentrations not to exceed based on a substance-specific evaluation EPA on its own initiative, under 100 parts per million (ppm). conducted by the U.S. Food and Drug FFDCA section 408(e), 21 U.S.C. Administration (FDA). Additionally, the 346a(e), is proposing to establish an III. Aggregate Risk Assessment and fragrance components listed in Unit II. exemption from the requirement of a Determination of Safety above have been evaluated and tolerance for residues of acetaldehyde Section 408(b)(2)(A)(i) of FFDCA approved for use as food flavoring (CAS Reg. No. 75–07–0), acetic acid allows EPA to establish a tolerance (the agents by the Joint Food and (CAS Reg. No. 64–19–7), allyl legal limit for a pesticide chemical Agricultural Organization of the United cyclohexyl propionate (CAS Reg. No. residue in or on a food) only if EPA Nations/World Health Organization 2705–87–5), butryic acid (CAS Reg. No. determines that the tolerance is ‘‘safe.’’ Expert Committee on Food Additives 107–92–6), butyl alcohol (CAS Reg. No. Section 408(b)(2)(A)(ii) of FFDCA (JECFA) and the European Food Safety 71–36–3), citral (CAS Reg. No. 5392–40– defines ‘‘safe’’ to mean that ‘‘there is a Agency (EFSA) as part of their 5), citronellol (CAS Reg. No. 106–22–9), reasonable certainty that no harm will assessment of more than 2,800 food citronellyl acetate (CAS Reg. No. 150– result from aggregate exposure to the flavoring substances. The EFSA and 84–5), b-damascone, (Z)- (CAS Reg. No. pesticide chemical residue, including JECFA food flavoring substance were 23726–92–3), decanal (CAS Reg. No. all anticipated dietary exposures and all conducted under an approach titled the 112–31–2), (E)-4-decenal (CAS Reg. No. other exposures for which there is Threshold of Toxicological Concern 65405–70–1), decanoic acid (CAS Reg. reliable information.’’ This includes (TTC). Under this approach, generic No. 334–48–5), 1-decanol (CAS Reg. No. exposure through drinking water and in human exposure threshold values for 112–30–1), 2,6-dimethyl-5-heptanal residential settings, but does not include both non-cancer and cancer endpoints (CAS Reg. No. 106–72–9), 2-dodecanol, occupational exposure. Section are set at a level below which there (2E)- (CAS Reg. No. 20407–84–5), d- 408(b)(2)(C) of FFDCA requires EPA to would be no appreciable risk to human limonene (CAS Reg. No. 5989–27–5), give special consideration to exposure health. These generic values allow for ethyl 2-methylbutyrate (CAS Reg. No. of infants and children to the pesticide the safety assessment of substances even

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in the absence of substance-specific day, and then dividing by a factor of 100 of 100 to derive the TTC value gives a hazard data. to ensure a margin of safety. very low probability (somewhere The derivation of TTC human For substances without structural between 0–5%) of any appreciable non- exposure threshold values for non- alerts for cancer, the TTC human cancer risk to human health from cancer endpoints is based on an exposure values for non-cancer risks are exposures to substances below the extensive reference database compiled considered protective of any potential Cramer Class I TTC value of 30 mg/kg/ by Munro, (Ref. 1) which included data cancer risk. For substances with a day’’ (Ref. 8) on chronic, subchronic, reproductive structural alert for cancer, a separate Use of TTC values for risk assessment and developmental toxicity studies TTC value has been derived. Originally, of the fragrance components listed in primarily derived from the reports of the FDA developed human exposure Unit II. is a more conservative US National Toxicology Program (NTP), threshold values to protect against all alternative to the chemical-specific the toxicological monographs of JECFA, chronic risks, including the endpoint of Population Adjusted Dose (PAD) or the EPA Integrated Risk Information cancer, without regard to whether the Reference Dose (RfD) approach typically System (IRIS), and the Developmental substance had a structural alert for used in Agency risk assessments. For and Reproductive Toxicology (DART) carcinogenicity (Ref. 3, 4, 5). FDA example, in the case of substances database compiled by the US National derived these threshold values using having chemical structures described by Library of Medicine. These sources were mathematical modeling of risks from Cramer Class I for which chemical- considered to contain well-validated animal bioassay data on over 500 known specific risk assessments have been toxicological data for well-defined genotoxic and non-genotoxic performed, these substances have PAD/ chemical structures, covering pesticides, carcinogens, based on their carcinogenic RfD values which are often orders of food additives, industrial and other potency. In 1995, FDA incorporated the magnitude greater than the types of chemicals. Only studies using threshold value in its threshold of corresponding TTC values (Ref 9). A the oral route of administration (gavage, regulation (TOR) policy for substances summary of the safe exposure levels diet, drinking water, or capsule) were present in food contact materials. (Ref corresponding to each of the exposure included. In all, the reference database 6). Under the TOR, substances used in scenarios considered the aggregate contained 2941 no-observed-adverse- food contact materials that are present exposure assessment of the fragrance effect levels (NOAELs) from studies in the diet at concentrations below the components listed in Unit II. is given conducted on 613 substances, and from threshold level are exempted from below: these the most conservative (lowest) regulation as food additives. 1. Acute dietary (all populations). NOAEL for each substance was entered Subsequently, FDA modified this There were no effects that could be on the published database. The NOAELs approach by adopting lower threshold attributed to a single dose in the in the reference database were those values for substances with a structural database. Therefore, a quantitative acute selected by the original authors of each alert for carcinogenicity. Kroes et al. dietary assessment is not necessary. study, apart from the studies in the IRIS (Ref. 7) This FDA approach as to 2. Chronic dietary (all populations). database, for which the NOAELs were substances with structural alerts for Concerns for chronic dietary exposures selected by the EPA. Munro commented carcinogenicity was further refined and exceeding the TTC value of 30 mg/kg/ that some authors were highly adopted by EFSA and JEFCA for use in day. conservative in their selection of a the TTC approach. 3. Incidental oral short-term (1 to 30 NOAEL, but such NOAELs were still The TTC approach has been days). Concerns for incidental oral used for the database to maintain a incorporated in the evaluations made by short-term exposures exceeding the TTC conservative approach. Munro also JECFA and EFSA in which the value of 30 mg/kg/day. stated that, in the calculation of the TTC organizations both concluded that the 4. Dermal short-term (1 to 30 days) values, NOAELs from subchronic each of the substances listed in Unit II. and intermediate-term (1 to 6 months). studies were divided by a factor of 3 to were safe for use as flavoring agents in Concern for dermal exposures exceeding approximate the NOAELs that are likely foods. Under 21 CFR 170.39 Threshold the TTC value of 30 mg/kg/day based on to be derived from a chronic study. of regulation for substances used in oral toxicity data and conservative The chemicals in the Munro database food-contact articles, FDA has issued assumption of 100% dermal absorption. were divided into three structural exemptions from regulation as food 5. Inhalation short-term (1 to 30 days) classes, based on a ‘‘decision tree’’ additives for a number of substances and intermediate-term (1 to 6 months). developed earlier by Cramer et al. (Ref. based on human exposure threshold Concern for inhalation exposures 2) Cramer Class I are chemicals of values. exceeding the TTC value of 30 mg/kg/ simple structure, with efficient modes of day based on oral toxicity data. Based B. Toxicological Points of Departure/ metabolism, suggesting low oral on subchronic inhalation data for a Levels of Concern toxicity; Cramer Class III are chemicals number of fragrance substances, with structures suggesting significant The human exposure threshold value including some of fragrance components toxicity or which did not permit any for threshold (i.e., noncancer) risks is listed in Unit II., in which no adverse strong initial presumption of safety, and based upon Cramer structural class. In effects were noted at exposure levels up Cramer Class II are chemicals with the case of the fragrance components to 1% of ambient air (Ref. 10), it is structures that were less innocuous than listed in Unit II., all of the substances reasonable to assume that in the case of Cramer Class I but without features are included in the Cramer Class I the fragrance components listed in Unit suggesting significant toxicity. Human category, which is defined as chemicals II. inhalation toxicity would not be exposure threshold values were derived of simple structure and efficient modes observed at doses below which oral by taking the lower 5th percentile value of metabolism, suggesting low oral toxicity is observed. of the distribution of NOAELs for the toxicity. An EFSA Scientific Committee 6. Cancer (Oral, dermal, inhalation). substances in each of the three Cramer critical evaluation of the human The Agency used a qualitative structure structural classes, multiplying by 60 to threshold values for threshold risks activity relationship (SAR) database, convert the values expressed as concluded that ‘‘the use of the 5th DEREK11, to determine if there were milligrams/kilograms (mg/kg) of body percentile No-observed-adverse-effect- structural alerts for potential weight (bw) per day into mg/person per level (NOAEL) and an uncertainty factor genotoxicity/carcinogenicity for any of

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the fragrance components. No structural amount of residues that can be the material present on food contact alerts for genotoxicity/carcinogenicity transferred to foods as a result of the surfaces will migrate to food (Ref 11). relevant to human exposure to these proposed use of the fragrance iii. Cancer. Based on the data substances as flavoring agents/fragrance components in food contact sanitizing summarized in Unit III. A., EPA has components were identified, therefore antimicrobial pesticide products. This concluded that the fragrance the use of the TTC human exposure same methodology has been utilized by components listed in Unit II. are not threshold for non-threshold risks for EPA in estimating dietary exposures to expected to be carcinogenic to humans. these fragrance components is not antimicrobial pesticides used in food- Therefore, a dietary exposure applicable. In these circumstances, handling settings. A complete assessment for the purpose of assessing assessment under the TTC value for description of the approach used to cancer risk is unnecessary. non-cancer risks is protective for all assess dietary exposures resulting from 2. Dietary exposure from drinking risks, including carcinogenicity. food contact sanitizing solution uses of water. The proposed use of the fragrance The risk assessment and use of human the fragrance components can be found components listed in Unit II. in threshold values for evaluation of food at http://www.regulations.gov in antimicrobial pesticide products has flavoring agents by JECFA and EFSA has document; ‘‘Various Fragrance only a limited opportunity to result in focused on oral toxicity and dietary Components: Human Health Risk contamination of drinking water exposure to substances via food and Assessment and Ecological Effects because these types of products are used feed. However, the applicability of the Assessment to Support Proposed inside of structures. There is the TTC approach to substance exposure by Exemption from the Requirement of a possibility of exposure to drinking water routes other than the oral route has been Tolerance When Used as Inert sources via down-the-drain releases and considered by the ESFA Scientific Ingredients in Pesticide Formulations,’’ discharges to waste water treatment Committee. The Scientific Committee pp. 5–8 in docket ID number EPA–HQ– plants; however, based on the extremely determined that when several routes of OPP–2013–0821. low concentrations of the fragrance exposure are to be taken into account i. Acute exposure. Quantitative acute components in pesticide formulations, they should be reflected in the exposure dietary exposure and risk assessments combined with the biodegradability of assessment used in the application of are performed for a food-use pesticide, the fragrance components, there would the TTC approach and that ‘‘the if a toxicological study has indicated the be at most a negligible exposure to application of the TTC approach to possibility of an effect of concern surface water or ground water. routes of exposure other than oral can occurring as a result of a 1-day or single Therefore, the use of these fragrance be done via route-to-route extrapolation, exposure. No such effects were components as inert ingredients is not as is often done in conventional risk identified in the toxicity database for expected to contribute to dietary assessment in cases where only oral the fragrance components listed in Unit exposure from drinking water. toxicity data are available.’’ II., therefore a quantitative acute dietary 3. From non-dietary exposure. The exposure assessment is unnecessary. term ‘‘residential exposure’’ is used in C. Exposure Assessment ii. Chronic exposure. In conducting this document to refer to non- 1. Dietary exposure from food and the chronic dietary exposure occupational, non-dietary exposure feed uses. In evaluating dietary assessment, the Agency believes the (e.g., for lawn and garden pest control, exposure to the fragrance components assumptions used to estimate chronic indoor pest control, termiticide, and flea listed in Unit II., EPA considered dietary exposures lead to an extremely and tick control on pets). exposure under the proposed tolerance conservative assessment of chronic The use of the fragrance components exemptions at a concentration not to dietary risk due to a series of in food contact surface antimicrobial exceed 100 ppm for each of the compounded conservatisms. First, when pesticide products could result in short- fragrance components listed in Unit II. a surface is treated with a disinfectant, and intermediate-term residential as well as any other sources of dietary a quantity of the disinfectant remains on exposures, adult handler dermal and exposure. The use limitation of 100 ppm the surface (residual solution). In the inhalation exposure; post-application was incorporated by the Agency to absence of any other data, EPA has used dermal and inhalation exposure and reflect maximum concentrations of an estimated worst-case concentration child’s post- application dermal and these fragrance components in of 1 mg of solution per square incidental oral exposure. In addition, antimicrobial pesticide formulations as centimeter (cm) of treated surface area non pesticidal uses of these substances well as to ensure that exposures to these for this quantity. Second, the as fragrance components in consumer fragrance components will be below conservatism of this methodology is products may also result in residential levels of concern. In conducting the compounded by EPA’s decision to dermal and inhalation exposure. dietary exposure assessment for the assume a worst case scenario that all However, these pesticidal and non fragrance components listed in Unit II., food that an individual consumes will pesticidal non-dietary exposures would EPA considered dietary exposure from come into contact with 4,000 cm 2 of be negligible in comparison to the potential residues in or on food sanitized non-porous food-contact highly conservative estimates of dietary resulting from the use as inert surfaces. This contact area represents all exposure as discussed in Unit III.C.1. ingredients in antimicrobial pesticide the surface area from silverware, china, above. Further information regarding product formulations from treated food and glass used by a person who EPA standard assumptions and generic contact surfaces; and from food that regularly eats three meals per day at an inputs for residential exposures may be contains the fragrance components as institutional or public facility. The found at http://www.epa.gov/pesticides/ flavoring agents. As to the residue levels surface area of counter tops that comes trac/science/trac6a05.pdf. in or food resulting from the inert in contact with food is expected to be 4. Cumulative effects from substances ingredient uses, in the absence of actual smaller than the surface area for food with a common mechanism of toxicity. dietary exposure data resulting from this utensils. As a conservative estimate, Section 408(b)(2)(D)(v) of FFDCA use, the EPA has utilized a conservative, EPA assumed that 2,000 cm 2 of treated requires that, when considering whether health-protective method of estimating counter top surface area, comes into to establish, modify, or revoke a dietary intake that is based upon contact with an individual’s food per tolerance, the Agency consider conservative assumptions related to the day. Third, EPA assumes that 100% of ‘‘available information’’ concerning the

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cumulative effects of a particular residential exposure to the appropriate Using the exposure assumptions pesticide’s residues and ‘‘other PODs to ensure that an adequate MOE described in this unit for short-term substances that have a common exists. exposures, EPA has concluded the mechanism of toxicity.’’ 1. Acute risk. An acute aggregate risk combined short-term food, water, and EPA has not found the fragrance assessment takes into account acute residential exposures result in aggregate components listed in Unit II. to share a exposure estimates from dietary exposures for each of the individual common mechanism of toxicity with consumption of food and drinking fragrance components listed in Unit II. any other substances, and these water. No adverse effect resulting from do not exceed 24% of the safe exposure fragrance components do not appear to a single oral exposure was identified level (i.e., a level equivalent to a PAD produce a toxic metabolite produced by and no acute dietary endpoint was or RfD) and therefore are not of concern. other substances. For the purposes of selected. Therefore, the fragrance this tolerance action, therefore, EPA has components are not expected to pose an 5. Intermediate-term risk. assumed that these fragrance acute risk. Intermediate-term aggregate exposure components do not have a common 2. Chronic risk. Using the exposure takes into account intermediate-term mechanism of toxicity with other assumptions described in this unit for residential exposure plus chronic substances. For information regarding chronic exposure, EPA has concluded exposure to food and water (considered EPA’s efforts to determine which that chronic exposure to each of the to be a background exposure level). fragrance components listed in Unit II. chemicals have a common mechanism Using the exposure assumptions of toxicity and to evaluate the from food and water will utilize 23% of described in this unit for intermediate- cumulative effects of such chemicals, the safe exposure level for the U.S. term exposures, EPA has concluded that see EPA’s Web site at http:// population and all subpopulations. the combined intermediate-term food, www.epa.gov/pesticides/cumulative. 3. From non-dietary exposure. The fragrance components listed in Unit II. water, and residential exposures result D. Safety Factor for Infants and may be utilized in antimicrobial in aggregate exposures that do not Children pesticide products with uses that could exceed 24% of the safe exposure level 1. In general. Section 408(b)(2)(C) of result in residential exposure such as for each of the fragrance components FFDCA provides that EPA shall apply hard surface cleaning products. For listed in Unit II. and not of concern. an additional tenfold (10X) margin of residential handler exposure, the 6. Aggregate cancer risk for U.S. safety for infants and children in the Agency assumed that most residential population. Based on the lack of case of threshold effects to account for use will result in short-term (1 to 30 structural alerts for carcinogenicity and prenatal and postnatal toxicity and the days) dermal and inhalation exposures. the lack of exceedance of the chronic completeness of the database on toxicity The Agency assumed that post- TTC value, the fragrance components application exposure in residential and exposure unless EPA determines listed in Unit II. are not expected to settings is expected to be short-term in based on reliable data that a different pose a cancer risk to humans. margin of safety will be safe for infants duration only but antimicrobial and children. This additional margin of products used as cleaning agents may be 7. Determination of safety. Based on safety is commonly referred to as the used in facilities where cleaning these risk assessments, EPA concludes FQPA Safety Factor (SF). In applying activities can occur on an intermediate- that there is a reasonable certainty that this provision, EPA either retains the term basis. Therefore, these post- no harm will result to the general default value of 10X, or uses a different application scenarios were included in population, or to infants and children additional safety factor when reliable the intermediate-term aggregate from aggregate exposure to residues of data available to EPA support the choice assessment. The scenarios evaluated each of the fragrance components listed of a different factor. were short- and intermediate term post- in Unit II. Therefore EPA is proposing The use of a threshold exposure level application dermal and inhalation to exempt from the requirement of a as described in Unit II. above is health (indoor), short- and intermediate-term tolerance under 40 CFR 180.940(a) the protective of any toxicity to infants and incidental oral ingestion from treated residues of acetaldehyde, acetic acid, children and the exposure assumptions indoor surfaces (hand-to-mouth vinyl/ allyl cyclohexyl propionate, butryic utilized in the risk assessment of the hard surfaces). acid, butyl alcohol, citral, citronellol, fragrance components are highly Further information regarding EPA citronellyl acetate, b-damascone, (Z)-, conservative (protective). These standard assumptions and generic decanal, (E)-4-decenal, decanoic acid, assessments will not underestimate the inputs for residential exposures may be 1-decanol, 2,6-dimethyl-5-heptanal, exposure and risks posed by these found at http://www.epa.gov/pesticides/ 2-dodecanol, (2E)-, d-limonene, ethyl 2- fragrance components and no additional science/residential-exposure-sop.html. methylbutyrate, (E)-geraniol, 4. Short-term risk. Short-term safety factor is needed for assessing risk (E)-geraniol acetate, heptanal), aggregate exposure takes into account to infants and heptanoic acid, heptyl alcohol, hexanal, short-term residential exposure plus E. Aggregate Risks and Determination of chronic exposure to food and water hexanoic acid, (Z)-3-hexenol, (Z)-3- Safety (considered to be a background hexenol acetate, hexyl acetate, hexyl EPA determines whether acute and exposure level). alcohol, lauric acid, lauric aldehyde, chronic dietary pesticide exposures are These fragrance components may be lauryl alcohol), methyl-a-ionone, 3- safe by comparing aggregate exposure utilized as inert ingredients in pesticide methyl-2-butenyl acetate, 2- estimates to the acute PAD (aPAD) and formulations registered for uses that methylundecanal, myristaldehyde, chronic PAD (cPAD). For linear cancer could result in short-term residential myristic acid, neryl acetate, n-hexanol, risks, EPA calculates the lifetime exposure, and the Agency has nonanal, nonanoic acid, nonyl alcohol, probability of acquiring cancer given the determined that it is appropriate to octanal, octanoic acid, 1-octanol, estimated aggregate exposure. Short-, aggregate chronic exposure through food palmitic acid, propionic acid, stearic intermediate-, and chronic-term risks and water with short-term residential acid, 2-tridecanal, 3,5,5- are evaluated by comparing the exposures to the fragrance components trimethylhexanal, undecanal, undecyl estimated aggregate food, water, and listed in Unit II. alcohol, valeraldehyde, and valeric acid.

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IV. Other Considerations Energy Supply, Distribution, or Use’’ (66 rule directly regulates growers, food FR 28355, May 22, 2001). This proposed processors, food handlers, and food A. Analytical Enforcement Methodology rule does not contain any information retailers, not States. This action does not An analytical method is not required collections subject to OMB approval alter the relationships or distribution of for enforcement purposes since the under the Paperwork Reduction Act power and responsibilities established Agency is establishing an exemption (PRA) (44 U.S.C. 3501 et seq.), or by Congress in the preemption from the requirement of a tolerance impose any enforceable duty or contain provisions of FFDCA section 408(n)(4). without any numerical limitation. The any unfunded mandate as described For these same reasons, the Agency has use limitation of 100 ppm will be under Title II. of the Unfunded determined that this proposed rule does enforced through the pesticide Mandates Reform Act of 1995 (UMRA) not have any ‘‘tribal implications’’ as registration process under the FIFRA, 7 (2 U.S.C. 1501 et seq.). Nor does it described in Executive Order 13175, U.S.C. 136 et seq. EPA will not register require any special considerations entitled ‘‘Consultation and Coordination any food-contact use antimicrobial under Executive Order 12898, entitled with Indian Tribal Governments’’ (65 FR pesticide for sale or distribution ‘‘Federal Actions to Address 67249, November 9, 2000). Executive containing any of the fragrance Environmental Justice in Minority Order 13175, requires EPA to develop components listed in Unit II. at Populations and Low-Income an accountable process to ensure concentrations exceeding 100 ppm. Populations’’ (59 FR 7629, February 16, ‘‘meaningful and timely input by tribal V. Conclusion 1994); or OMB review or any Agency officials in the development of action under Executive Order 13045, regulatory policies that have tribal An exemption from the requirement entitled ‘‘Protection of Children from implications.’’ ‘‘Policies that have tribal for a tolerance is proposed for residues Environmental Health Risks and Safety implications’’ is defined in the of acetaldehyde, acetic acid, allyl Executive order to include regulations cyclohexyl propionate, butryic acid, Risks’’ (62 FR 19885, April 23, 1997). that have ‘‘substantial direct effects on butyl alcohol, citral, citronellol, This action does not involve any one or more Indian tribes, on the citronellyl acetate, b-damascone, (Z)-, technical standards that would require relationship between the Federal decanal, (E)-4-decenal, decanoic acid, 1- Agency consideration of voluntary Government and the Indian tribes, or on decanol, 2,6-dimethyl-5-heptanal, 2- consensus standards pursuant to section the distribution of power and dodecanol, (2E)-, d-limonene, ethyl 2- 12(d) of the National Technology responsibilities between the Federal methylbutyrate, (E)-geraniol, (E)- Transfer and Advancement Act of 1995 Government and Indian tribes.’’ This geraniol acetate, heptanal), heptanoic (NTTAA) (15 U.S.C. 272 note). The proposed rule will not have substantial acid, heptyl alcohol, hexanal, hexanoic Agency hereby certifies under the direct effects on tribal governments, on acid, (Z)-3-hexenol, (Z)-3-hexenol Regulatory Flexibility Act (RFA) (5 the relationship between the Federal acetate, hexyl acetate, hexyl alcohol, U.S.C. 601 et seq.) that this proposed Government and Indian tribes, or on the lauric acid, lauric aldehyde, lauryl action will not have significant negative distribution of power and alcohol), methyl-a-ionone, 3-methyl-2- economic impact on a substantial responsibilities between the Federal butenyl acetate, 2-methylundecanal, number of small entities. Establishing Government and Indian tribes, as myristaldehyde, myristic acid, neryl an a pesticide tolerance or an exemption specified in Executive Order 13175. acetate, n-hexanol, nonanal, nonanoic from the requirement of a pesticide Thus, Executive Order 13175 does not acid, nonyl alcohol, octanal, octanoic tolerance is, in effect, the removal of a apply to this proposed rule. acid, 1-octanol, palmitic acid, propionic regulatory restriction on pesticide acid, stearic acid, 2-tridecanal, 3,5,5- residues in food and thus such an action VII. References will not have any negative economic trimethylhexanal, undecanal, undecyl 1. Munro, I.C. A Procedure for the Safety alcohol, valeraldehyde, and valeric acid impact on any entities, including small entities. Evaluation of Flavouring Substances. when used as inert ingredients Toxicological evaluation of certain food (fragrance components) in antimicrobial In addition, the Agency has additives and contaminants. Joint FAO/ pesticide formulations for use on food determined that this action will not WHO Expert Committee on Food contact surfaces in public eating places, have a substantial direct effect on States, Additives. WHO Food Additive Series dairy processing equipment, and food on the relationship between the national 35, Annex 5. 1996. http:// processing equipment and utensils at government and the States, or on the www.inchem.org/documents/jecfa/ distribution of power and jecmono/v35je21.htm. end-use concentrations not to exceed 2. Cramer, G. M., Ford, R. A., Hall, R. L. 100 ppm. responsibilities among the various Estimation of Toxic Hazard—A Decision levels of government, as specified in VI. Statutory and Executive Order Tree Approach. Food and Cosmetic Executive Order 13132, entitled Toxicology. Vol. 16 pp. 255–276. 1978 Reviews ‘‘Federalism’’ (64 FR 43255, August 10, 3. Rulis, A.M. De minimis and the Threshold This document proposes to establish 1999). Executive Order 13132 requires of Regulation. Food Protection exemptions from tolerances under EPA to develop an accountable process Technology Proceedings of the 1986 FFDCA section 408(d). The Office of to ensure ‘‘meaningful and timely input Conference for Food Protection. Eds Management and Budget (OMB) has by State and local officials in the Felix, C.W. Lewis Publishing, Inc. Chelsea, Michigan. pp. 29–37. 1986. exempted these types of actions from development of regulatory policies that 4. Rulis, A.M. Establishing a Threshold of review under Executive Order 12866, have federalism implications.’’ ‘‘Policies Regulation. Risk Assessment in Setting entitled ‘‘Regulatory Planning and that have federalism implications’’ is National Priorities. Eds Bonin, J.J., Review’’ (58 FR 51735, October 4, 1993). defined in the Executive order to Stevenson, D.E. Plenum Publishing Because this proposed rule has been include regulations that have Corporation, New York. pp. 271–278. exempted from review under Executive ‘‘substantial direct effects on the States, 1989. Order 12866 due to its lack of on the relationship between the national 5. Rulis, AM. Threshold of Regulation: Options for Handling Minimal Risk significance, this proposed rule is not government and the States, or on the Situations. Food Safety Assessment, subject to Executive Order 13211, distribution of power and Chapter 14, Eds Finlay, J.W., Robinson, entitled ‘‘Actions Concerning responsibilities among the various S.F., Armstrong, D.J. American Chemical Regulations That Significantly Affect levels of government.’’ This proposed Society Symposium Series No. 484.

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American Chemical Society, and related esters evaluated by JECFA Agricultural commodities, Pesticides Washington, DC. pp 132–139. 1992. (69th meeting) structurally related to and pests, Reporting and recordkeeping 6. U.S. Food and Drug Administration (FDA). esters of branched- and straight-chain requirements. Food Additives: Threshold of Regulation aliphatic saturated primary alcohols and for Substances Used in Food-Contact of one secondary alcohol, and branched- Dated: July 14, 2014. Articles. Federal Register (60 FR 36582– and straight-chain unsaturated Jack Housenger, 36596, Monday, July 17, 1995). carboxylic acids evaluated by EFSA in Director, Office of Pesticide Programs. 7. Kroes, R., Renwick, A. G., Cheeseman, et FGE.05Rev1 (2008). EFSA Journal 2010; al. Structure-based Thresholds of 8(11):1207. 51 pp. doi:10.2903/ Therefore, it is proposed that 40 CFR Toxicological Concern (TTC): Guidance j.efsa.2010.1207. http:// chapter I be amended as follows: for Application to Substances Present at www.efsa.europa.eu/en/efsajournal/doc/ Low Levels in the Diet. Food and 1207.pdf. PART 180—[AMENDED] Chemical Toxicology. Vol. 42 pp. 65–83. 10. Fukayama, M.Y., Easterday, O.D., 2004. Serafino, P.A., et al. Subchronic ■ 1. The authority citation for part 180 8. EFSA Scientific Committee. Scientific Inhalation Studies of Complex Fragrance continues to read as follows: Opinion on Exploring Options for Mixtures in Rats and Hamsters. Toxicol Providing Advice About Possible Human Lett. 20;111(1–2). pp. 175–187. 1999. Authority: 21 U.S.C. 321(q), 346a and 371. 11. U.S. Environmental Protection Agency. Health Risks Based on the Concept of ■ 2. In § 180.940, add alphabetically the Threshold of Toxicological Concern Reregistration Eligibility Decision for (TTC). EFSA Journal 2012;10 (7):2750 Alkyl Dimethyl Benzyl Ammonium following inert ingredients to the table 103 pp. doi:10.2903/j.efsa.2012.2750. Chloride (ADBAC). pp. 15–16. 2006. in paragraph (a) to read as follows: www.efsa.europa.eu/efsajournal. http://www.epa.gov/pesticides/ reregistration/REDs/adbac_red.pdf. § 180.940 Tolerance exemptions for active 9. European Food Safety Authority. Scientific and inert ingredients for use in Opinion on Flavouring Group Evaluation List of Subjects in 40 CFR Part 180 antimicrobial formulations (Food-contact 95 (FGE.95): Consideration of aliphatic, surface sanitizing solutions). linear or branched-chain saturated and Environmental protection, unsaturated alcohols, aldehydes, acids Administrative practice and procedure, (a) * * *

Pesticide chemical CAS Reg. No. Limits

Acetaldehyde ...... 75–07–0 When ready for use, the end-use concentration is not to exceed 100 ppm. Acetic acid ...... 64–19–7 When ready for use, the end-use concentration is not to exceed 100 ppm.

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Allyl cyclohexyl propionate ...... 2705–87–5 When ready for use, the end-use concentration is not to exceed 100 ppm.

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Butryic acid ...... 107–92–6 When ready for use, the end-use concentration is not to exceed 100 ppm. Butyl alcohol ...... 71–36–3 When ready for use, the end-use concentration is not to exceed 100 ppm. Citral ...... 5392–40–5 When ready for use, the end-use concentration is not to exceed 100 ppm. Citronellol ...... 106–22–9 When ready for use, the end-use concentration is not to exceed 100 ppm. Citronellyl acetate ...... 150–84–5 When ready for use, the end-use concentration is not to exceed 100 ppm.

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b-Damascone, (Z)- ...... 23726–92–3 When ready for use, the end-use concentration is not to exceed 100 ppm. Decanal ...... 112–31–2 When ready for use, the end-use concentration is not to exceed 100 ppm. (E)-4-Decenal ...... 65405–70–1 When ready for use, the end-use concentration is not to exceed 100 ppm. Decanoic acid ...... 334–48–5 When ready for use, the end-use concentration is not to exceed 100 ppm. 1-Decanol ...... 112–30–1 When ready for use, the end-use concentration is not to exceed 100 ppm.

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2,6-Dimethyl-5-heptanal ...... 106–72–9 When ready for use, the end-use concentration is not to exceed 100 ppm. 2-Dodecanol, (2E)- ...... 20407–84–5 When ready for use, the end-use concentration is not to exceed 100 ppm.

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Ethyl 2-methylbutyrate ...... 452–79–1 When ready for use, the end-use concentration is not to exceed 100 ppm.

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(E)-Geraniol ...... 106–24–1 When ready for use, the end-use concentration is not to exceed 100 ppm. (E)-Geraniol acetate ...... 105–87–3 When ready for use, the end-use concentration is not to exceed 100 ppm. Heptanal ...... 111–71–7 When ready for use, the end-use concentration is not to exceed 100 ppm. Heptanoic acid ...... 111–14–8 When ready for use, the end-use concentration is not to exceed 100 ppm. Heptyl alcohol ...... 111–70–6 When ready for use, the end-use concentration is not to exceed 100 ppm. Hexanal ...... 66–25–1 When ready for use, the end-use concentration is not to exceed 100 ppm. Hexanoic acid ...... 142–62–1 When ready for use, the end-use concentration is not to exceed 100 ppm. n-Hexanol ...... 111–27–3 When ready for use, the end-use concentration is not to exceed 100 ppm. (Z)-3-Hexenol ...... 928–96–1 When ready for use, the end-use concentration is not to exceed 100 ppm. (Z)-3-Hexenol acetate ...... 3681–71–8 When ready for use, the end-use concentration is not to exceed 100 ppm. Hexyl acetate ...... 142–92–7 When ready for use, the end-use concentration is not to exceed 100 ppm. Hexyl alcohol ...... 111–27–3 When ready for use, the end-use concentration is not to exceed 100 ppm.

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Pesticide chemical CAS Reg. No. Limits

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Lauric acid ...... 143–07–7 When ready for use, the end-use concentration is not to exceed 100 ppm. Lauric aldehyde ...... 112–54–9 When ready for use, the end-use concentration is not to exceed 100 ppm. Lauryl alcohol ...... 112–53–8 When ready for use, the end-use concentration is not to exceed 100 ppm. d-Limonene ...... 5989–27–5 When ready for use, the end-use concentration is not to exceed 100 ppm.

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Methyl-a-ionone ...... 127–42–4 When ready for use, the end-use concentration is not to exceed 100 ppm. 3-Methyl-2-butenyl acetate ...... 1191–16–8 When ready for use, the end-use concentration is not to exceed 100 ppm.

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2-Methylundecanal ...... 110–41–8 When ready for use, the end-use concentration is not to exceed 100 ppm.

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Myristaldehyde ...... 124–25–4 When ready for use, the end-use concentration is not to exceed 100 ppm. Myristic acid ...... 544–63–8 When ready for use, the end-use concentration is not to exceed 100 ppm. Neryl acetate ...... 141–12–8 When ready for use, the end-use concentration is not to exceed 100 ppm.

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Nonanal ...... 124–19–6 When ready for use, the end-use concentration is not to exceed 100 ppm. Nonanoic acid ...... 112–05–0 When ready for use, the end-use concentration is not to exceed 100 ppm. Nonyl alcohol ...... 143–08–8 When ready for use, the end-use concentration is not to exceed 100 ppm.

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Octanal ...... 124–13–0 When ready for use, the end-use concentration is not to exceed 100 ppm.

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Octanoic acid ...... 124–07–2 When ready for use, the end-use concentration is not to exceed 100 ppm. 1-Octanol ...... 111–87–5 When ready for use, the end-use concentration is not to exceed 100 ppm.

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Palmitic acid ...... 57–10–3 When ready for use, the end-use concentration is not to exceed 100 ppm.

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Propionic acid ...... 79–09–4 When ready for use, the end-use concentration is not to exceed 100 ppm.

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Stearic acid ...... 57–11–4 When ready for use, the end-use concentration is not to exceed 100 ppm.

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2-Tridecanal ...... 7774–82–5 When ready for use, the end-use concentration is not to exceed 100 ppm. 3,5,5-Trimethylhexanal ...... 5435–64–3 When ready for use, the end-use concentration is not to exceed 100 ppm. Undecanal ...... 112–44–7 When ready for use, the end-use concentration is not to exceed 100 ppm. Undecyl alcohol ...... 112–42–5 When ready for use, the end-use concentration is not to exceed 100 ppm. Valeraldehyde ...... 110–62–3 When ready for use, the end-use concentration is not to exceed 100 ppm. Valeric acid ...... 109–52–4 When ready for use, the end-use concentration is not to exceed 100 ppm.

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* * * * * [FR Doc. 2014–17613 Filed 7–24–14; 8:45 am] BILLING CODE 6560–50–P

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