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Administrator of this final rule does not reference, Ozone, Volatile organic Subpart S—Kentucky affect the finality of this action for the compounds. purposes of judicial review nor does it Dated: September 1, 2010. ■ 2. Section 52.920(c) Table 1 is extend the time within which a petition Beverly H. Banister, amended by revising the entries for ‘‘401 for judicial review may be filed, and KAR 51:001,’’ ‘‘401 KAR 51:017,’’ and Acting Regional Administrator, Region 4. shall not postpone the effectiveness of ‘‘401 KAR 51:052’’ to read as follows: such rule or action. This action may not ■ 40 CFR part 52 is amended as follows: be challenged later in proceedings to § 52.920 Identification of plan. enforce its requirements. (See section PART 52—[AMENDED] * * * * * 307(b)(2).) (c) * * * List of Subjects in 40 CFR Part 52 ■ 1. The authority citation for part 52 continues to read as follows: Environmental protection, Air pollution control, Incorporation by Authority: 42 U.S.C. 7401 et seq.

TABLE 1—EPA-APPROVED KENTUCKY APPROVED KENTUCKY REGULATIONS

State citation Title/subject State effective date EPA approval date Explanation

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Chapter 51 Attainment and Maintenance of the National Ambient Air Quality Standards

401 KAR 51:001 ...... Definitions for 401 2/5/2010 9/15/2010 [Insert cita- Except the phrase ‘‘except ethanol produc- KAR Chapter 51. tion of publication]. tion facilities producing ethanol by natural fermentation under the North American Industry Classification System (NAICS) codes 325193 or 312140,’’ in 401 KAR 51:001 Section 1 (118)(1)(b)(i) and the phrase ‘‘except ethanol production facili- ties producing ethanol by natural fer- mentation under NAICS codes 325193 or 312140,’’ in 401 KAR 51:001 Section 1(118) (2)(c)(20).

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401 KAR 51:017 ...... Prevention of signifi- 2/5/2010 9/15/2010 [Insert cita- Except the phrase ‘‘except ethanol produc- cant deterioration tion of publication]. tion facilities producing ethanol by natural of air quality. fermentation under the North American Industry Classification System (NAICS) codes 325193 or 312140;’’ in 401 KAR 51:017 Section 7(1)(c)20. 401 KAR 51:052 ...... Review of new 2/5/2010 9/15/2010 [Insert cita- Except the phrase ‘‘except ethanol produc- sources in or im- tion of publication]. tion facilities producing ethanol by natural pacting upon non- fermentation under the North American attainment areas. Industry Classification System (NAICS) codes 325193 or 312140,’’ in 401 KAR 51:052 Section 2 (3)(t).

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* * * * * SUMMARY: This regulation establishes an DATES: This regulation is effective [FR Doc. 2010–22856 Filed 9–14–10; 8:45 am] exemption from the requirement of a September 15, 2010. Objections and BILLING CODE 6560–50–P tolerance for residues of ammonium requests for hearings must be received formate (CAS Reg. No. 540–69–2) when on or before November 15, 2010, and used as an inert ingredient (complexing must be filed in accordance with the ENVIRONMENTAL PROTECTION or fixing agent with copper compounds) instructions provided in 40 CFR part AGENCY in pesticide formulations for certain pre- 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). 40 CFR Part 180 harvest uses. Phyton Corporation submitted a petition to EPA under the ADDRESSES: EPA has established a [EPA–HQ–OPP–2006–0121; FRL–8839–3] Federal Food, Drug, and Cosmetic Act docket for this action under docket (FFDCA), requesting establishment of an identification (ID) number EPA–HQ– Ammonium Formate; Exemption from exemption from the requirement of a OPP–2006–0121. All documents in the the Requirement of a Tolerance tolerance. This regulation eliminates the docket are listed in the docket index AGENCY: Environmental Protection need to establish a maximum available at http://www.regulations.gov. Agency (EPA). permissible level for residues of Although listed in the index, some information is not publicly available, ACTION: Final rule. ammonium formate. e.g., Confidential Business Information

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(CBI) or other information whose C. Can I File an Objection or Hearing petition requested that 40 CFR 180.920 disclosure is restricted by statute. Request? be amended by establishing an Certain other material, such as Under section 408(g) of FFDCA, 21 exemption from the requirement of a copyrighted material, is not placed on U.S.C. 346a, any person may file an tolerance for residues of ammonium the Internet and will be publicly objection to any aspect of this regulation formate (CAS Reg. No. 540–69–2) when available only in hard copy form. and may also request a hearing on those used as an inert ingredient (complexing Publicly available docket materials are objections. The EPA procedural or fixing agent) with the active ingredient copper in pesticide available in the electronic docket at regulations which govern the formulations applied to growing crops. http://www.regulations.gov, or, if only submission of objections and requests That notice referenced a summary of the available in hard copy, at the OPP for hearings appear in 40 CFR part 178. petition which is available in the Regulatory Public Docket in Rm. S– You must file your objection or request docket, http://www.regulations.gov. 4400, One Potomac Yard (South Bldg.), a hearing on this regulation in There were no comments received in 2777 S. Crystal Dr., Arlington, VA. The accordance with the instructions Docket Facility is open from 8:30 a.m. response to the notice of filing. provided in 40 CFR part 178. To ensure Based upon review of the data to 4 p.m., Monday through Friday, proper receipt by EPA, you must excluding legal holidays. The Docket supporting the petition, EPA has identify docket ID number EPA–HQ– modified the exemption requested to Facility telephone number is (703) 305– OPP–2006–121 in the subject line on the 5805. not restrict to use with the active first page of your submission. All ingredient copper. No limitations are FOR FURTHER INFORMATION CONTACT: objections and requests for a hearing necessary because no hazard was Alganesh Debesai, Registration Division must be in writing, and must be identified. (7505P), Office of Pesticide Programs, received by the Hearing Clerk on or Environmental Protection Agency, 1200 before November 15, 2010. Addresses III. Inert Ingredient Definition Pennsylvania Ave., NW., Washington, for mail and hand delivery of objections Inert ingredients are all ingredients DC 20460–0001; telephone number: and hearing requests are provided in 40 that are not active ingredients as defined (703) 308–8353; e-mail address: CFR 178.25(b). in 40 CFR 153.125 and include, but are [email protected]. In addition to filing an objection or not limited to, the following types of hearing request with the Hearing Clerk SUPPLEMENTARY INFORMATION: ingredients (except when they have a as described in 40 CFR part 178, please pesticidal efficacy of their own): I. General Information submit a copy of the filing that does not Solvents such as alcohols and contain any CBI for inclusion in the A. Does this Action Apply to Me? hydrocarbons; surfactants such as public docket that is described in polyoxyethylene polymers and fatty You may be potentially affected by ADDRESSES. Information not marked acids; carriers such as clay and this action if you are an agricultural confidential pursuant to 40 CFR part 2 diatomaceous earth; thickeners such as producer, food manufacturer, or may be disclosed publicly by EPA carrageenan and modified cellulose; pesticide manufacturer. Potentially without prior notice. Submit your wetting, spreading, and dispersing affected entities may include, but are copies, identified by docket ID number agents; propellants in aerosol not limited to: EPA–HQ–OPP–2006–0121, by one of dispensers; microencapsulating agents; • Crop production (NAICS code 111). the following methods: and emulsifiers. The term ‘‘inert’’ is not • • Animal production (NAICS code Federal eRulemaking Portal: http:// intended to imply nontoxicity; the 112). www.regulations.gov. Follow the on-line ingredient may or may not be instructions for submitting comments. chemically active. Generally, EPA has • Food manufacturing (NAICS code • Mail: Office of Pesticide Programs exempted inert ingredients from the 311). (OPP) Regulatory Public Docket (7502P), • requirement of a tolerance based on the Pesticide manufacturing (NAICS Environmental Protection Agency, 1200 low toxicity of the individual inert code 32532). Pennsylvania Ave., NW., Washington, ingredients. This listing is not intended to be DC 20460–0001. exhaustive, but rather provides a guide • Delivery: OPP Regulatory Public IV. Aggregate Risk Assessment and for readers regarding entities likely to be Docket (7502P), Environmental Determination of Safety affected by this action. Other types of Protection Agency, Rm. S–4400, One Section 408(c)(2)(A)(i) of FFDCA entities not listed in this unit could also Potomac Yard (South Bldg.), 2777 S. allows EPA to establish an exemption be affected. The North American Crystal Dr., Arlington, VA. Deliveries from the requirement for a tolerance (the Industrial Classification System are only accepted during the Docket legal limit for a pesticide chemical (NAICS) codes have been provided to Facility’s normal hours of operation residue in or on a food) only if EPA assist you and others in determining (8:30 a.m. to 4 p.m., Monday through determines that the tolerance is ‘‘safe.’’ whether this action might apply to Friday, excluding legal holidays). Section 408(b)(2)(A)(ii) of FFDCA certain entities. If you have any Special arrangements should be made defines ‘‘safe’’ to mean that ‘‘there is a questions regarding the applicability of for deliveries of boxed information. The reasonable certainty that no harm will this action to a particular entity, consult Docket Facility telephone number is result from aggregate exposure to the the person listed under FOR FURTHER (703) 305–5805. pesticide chemical residue, including INFORMATION CONTACT. all anticipated dietary exposures and all II. Petition for Exemption other exposures for which there is B. How Can I Get Electronic Access to In the Federal Register of April 21, reliable information.’’ This includes Other Related Information? 2006 (71 FR 20671) (FRL–8067–3), EPA exposure through drinking water and in You may access a frequently updated issued a notice pursuant to section 408 residential settings, but does not include electronic version of 40 CFR part 180 of FFDCA, 21 U.S.C. 346a, announcing occupational exposure. Section through the Government Printing the filing of a pesticide petition (PP 408(b)(2)(C) of FFDCA requires EPA to Office’s e-CFR cite at http:// 6E7028) by Phyton Corporation, 7449 give special consideration to exposure www.gpoaccess.gov/ecfr. Cahill Rd., Edina, MN 55439. The of infants and children to the pesticide

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chemical residue in establishing a Proposed Exemption from the groups. In rats, hematologic changes tolerance and to ‘‘ensure that there is a Requirement of a Tolerance When Used observed were all minimal and, reasonable certainty that no harm will as an Inert Ingredient in Pesticide generally, were consistent with result to infants and children from Formulations Applied Pre-harvest in hemoconcentration. Therefore, they aggregate exposure to the pesticide docket ID number EPA–HQ–OPP–2006– were not considered as toxicologically chemical residue.’’ 0121. relevant. Few and slight changes of the EPA establishes exemptions from the Ammonium formate breaks down into biochemical serum parameters were requirement of a tolerance only in those ammonium and formate ions. observed but not considered as adverse. cases where it can be clearly Ammonium ions are a toxic waste No unusual gross lesions were observed. demonstrated that the risks from product of the metabolism in animals; In rats, absolute liver weights were aggregate exposure to pesticide they are ubiquitous in the natural increased in the males of all test groups chemical residues under reasonably environment and can be considered as while the relative liver weights were foreseeable circumstances will pose no having little toxicity or hazard risk. In increased in the three highest dose appreciable risks to human health. In fish and aquatic invertebrates, it is groups. Absolute and relative lung order to determine the risks from excreted directly into the water. In weights were reduced in female rats in aggregate exposure to pesticide inert mammals, sharks, and amphibians, it is all dose groups; in males, the relative ingredients, the Agency considers the converted in the urea cycle to urea, lung weights were reduced in all toxicity of the inert in conjunction with because urea is less toxic and can be exposure groups and absolute lung possible exposure to residues of the stored more efficiently. In birds, weights were reduced in the two highest inert ingredient through food, drinking reptiles, and terrestrial snails, metabolic dose groups. However, these changes in water, and through other exposures that ammonium is converted into uric acid, liver weights and lungs were not occur as a result of pesticide use in which is solid, and can therefore be considered as adverse because they residential settings. If EPA is able to excreted with minimal water. Formic seem without histopathological determine that a finite tolerance is not acid is readily metabolized and correlation. Histopathological changes necessary to ensure that there is a eliminated by the body; it slowly at the respiratory and olfactory nasal reasonable certainty that no harm will decomposes to carbon monoxide and epithelia were restricted to the highest result from aggregate exposure to the water. dose groups. The no observed adverse inert ingredient, an exemption from the The toxicological database for effect level (NOAEL) is 0.061 mg/L (32 requirement of a tolerance may be ammonium formate is limited. There is ppm) in mice based on a decrease in established. available data on formic acid and body weight gains seen at the lowest Consistent with section 408(c)(2)(A) related formate compounds (such as observed adverse effect level (LOAEL) of of FFDCA, and the factors specified in calcium and sodium formate), which 0.122 mg/L (64 ppm). The NOAEL in FFDCA section 408(c)(2)(B), EPA has can serve as suitable surrogates for rats is 0.122 mg/L equal to (64 ppm) reviewed the available scientific data ammonium formate. Studies conducted based on a decrease in body weight and other relevant information in with methanol are also applicable to gains in mice and histopathological support of this action. EPA has formate compounds, since methanol is changes seen in the respiratory and sufficient data to assess the hazards of metabolized into formic acid. olfactory epithelia at the LOAEL of and to make a determination on Acute oral toxicity of ammonium 0.244 mg/L (124 ppm). Lifetime and aggregate exposure for ammonium formate in mice is reported to be repeat dose drinking water studies were formate including exposure resulting moderate via oral route (LD50 2,250 conducted in rats with calcium formate from the exemption established by this milligrams/kilogram (mg/kg)). Acute and sodium formate, respectively. action. EPA’s assessment of exposures oral toxicity studies have been Toxicity was not observed during either and risks associated with ammonium performed with formic acid, calcium study at doses up to 200 mg/kg/day and formate follows. formate and sodium formate; they all 100 mg/kg/day for calcium format and have relatively low toxicity via this A. Toxicological Profile sodium formate, respectively. route of exposure. In a reproduction study in rats and EPA has evaluated the available A subchronic inhalation (13–week) mice with formic acid via inhalation toxicity data and considered their study was performed by the NTP with route, no effects on sperm motility, validity, completeness, and reliability as formic acid in mice and rats at sperm concentration, testicular and well as the relationship of the results of concentrations of 0.015, 0.030, 0.061, epididymal weight or on the duration of the studies to human risk. EPA has also 0.122, or 0.244 milligrams/liter (mg/L) estrous cycles were observed. In mice, considered available information equal to (8, 16, 32, 64, or 128 parts per formic acid showed no effects on the concerning the variability of the million (ppm)) for 13 weeks. Body testicular and epididymal weight or on sensitivities of major identifiable weight gains were significantly the duration of the estrous cycles. In a subgroups of consumers, including decreased in mice exposed to 64 and three generation reproduction study in infants and children. Specific 128 ppm formic acid. Changes in organ rats via drinking water, no treatment information on the studies received and weights in mice were limited largely to related effects were observed in the the nature of the adverse effects caused increases in relative weights in animals parental animals and off springs at by ammonium formate are discussed in in the 128 ppm groups. This was doses up to 200 mg/kg/day. this unit. primarily a reflection of the lower body In an in vitro incubation in whole The following provides a brief weights of these animals compared to embryo culture study in rats with formic summary of the risk assessment and controls, and of the greater relative acid, incubations showed significant conclusions for the Agency’s review of weight of organs in smaller animals. In and concentration-dependent reduction ammonium formate. The Agency’s full mice, there were no exposure-related of yolk sac diameter, crown-rump decision document for this action can be gross lesions; microscopic changes length, head length, somite number, and found at http://www.regulations.gov in attributed to toxicity of formic acid were developmental score after 24–hours and the document: Ammonium Formate. limited to degeneration of the olfactory of crown-rump length, head length, Human Health Risk Assessment and epithelium of the nose in a few mice somite number and developmental score Ecological Effects Summary to Support from the 64 and 128 ppm exposure after 48–hours. Embryo lethality was

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significantly increased in the highest readily converted to carbon dioxide in upper bound exposure estimates for the concentration after 24–hours and in the the environment by biodegradation or subject inert ingredient. Upper bound two highest concentrations after 48– photo oxidation. exposure estimates are based on the hours. Protein and DNA concentrations highest tolerance for a given commodity B. Toxicological Points of Departure/ showed significant and concentration from a list of high-use insecticides, Levels of Concern dependent decreased in both cases. The herbicides, and fungicides. A complete number of anomalies (open anterior and No toxicological endpoints of concern description of the general approach posterior neuropores, rotatory defects were identified based on available taken to assess inert ingredient risks in and enlarged maxillary process) showed toxicity studies on surrogate chemicals. the absence of residue data is contained a significant increase only at the highest Most of these studies were not in the memorandum entitled ‘‘Alkyl doses after 48–hours. Considering the conducted up to the limit dose. The Amines Polyalkoxylates (Cluster 4): results of in vivo reproduction study in highest dose of 200 mg/kg/day in a Acute and Chronic Aggregate (Food and mice and rats with formic acid and 3– lifelong study in rats via drinking water Drinking Water) Dietary Exposure and generation reproduction study in rats did not produce any systemic toxicity. Risk Assessments for the Inerts.’’ (DP via drinking water at doses up to and Therefore, a conservative risk Barcode: 361707, S. Piper, 2/25/2009) including 200 mg/kg/day, there is less assessment was conducted using a and can be found at http:// confidence in the results of in vitro NOAEL of 200 mg/kg/day for chronic www.regulations.gov in docket ID study. In addition, no developmental dietary and short- and intermediate- number EPA–HQ–OPP–2008–0738. toxicity was seen in several term dermal exposure risk estimates. An In the dietary exposure assessment, developmental toxicity studies in mice uncertainty/safety factor of 100X (10X the Agency assumed that the residue and rats with calcium and sodium for interspecies variability and 10X for level of the inert ingredient would be no formate described below. interspecies extrapolation) was used. higher than the highest tolerance for a In developmental toxicity studies The Food Quality Protection Act given commodity. Implicit in this with calcium and sodium formate in (FQPA) factor of 10X was reduced to 1X; assumption is that there would be rats and mice, respectively, there were therefore, the chronic Reference Dose similar rates of degradation (if any) no statistical differences in organ and (cRfD) is equal to chronic Population between the active and inert ingredient bone abnormalities and growth of Adjusted Dose (cPAD). A 100% dermal and that the concentration of inert treated offspring to controls were absorption is assumed for converting ingredient in the scenarios leading to similar. There was no reduction of oral to dermal equivalent dose in the these highest of tolerances would be no fertility, maternal toxicity, embryotoxic absence of dermal toxicity or dermal higher than the concentration of the or teratogenic effects observed. The absorption studies. For short- and active ingredient. NOAEL for the maternal and intermediate-term inhalation exposure, The Agency believes the assumptions developmental toxicity in rats with the route-specific study was used. The used to estimate dietary exposures lead calcium formate via drinking water was NOAEL of 0.62 (32 ppm) was observed to an extremely conservative assessment 200 mg/kg/day (the highest dose tested; in a 90–day inhalation toxicity study in of dietary risk due to a series of HDT). The NOAEL for the maternal and rats. The uncertainty factor is 100X (10X compounded conservatisms. First, developmental toxicity in mice with for interspecies variability and 10X for assuming that the level of residue for an sodium formate via gavage was 750 mg/ interspecies extrapolation). The FQPA inert ingredient is equal to the level of kg/day (HDT). factor of 10X was reduced to 1X. residue for the active ingredient will In mutagenicity studies with calcium, overstate exposure. The concentration of sodium and methyl formate, results of C. Exposure Assessment active ingredient in agricultural the test were negative for all chemicals. 1. Dietary exposure from food and products is generally at least 50% of the The weight-of-evidence suggested that feed uses. In evaluating dietary product and often can be much higher. inorganic formates are not mutagenic. exposure to ammonium formate, EPA Further, pesticide products rarely have In a non-Good Laboratory Practice considered exposure under the a single inert ingredient; rather there is (GLP) lifelong (2–3 years) drinking proposed exemption from the generally a combination of different water study with Wistar rats, test requirement of a tolerance. EPA inert ingredients used which animals were exposed to calcium assessed dietary exposures from additionally reduces the concentration formate at concentrations of 0.2% and ammonium formate in food as follows: of any single inert ingredient in the 0.4% (150–200 mg/kg/day). No i. Acute exposure. No adverse effect pesticide product in relation to that of neoplasias were observed. In a separate attributable to a single exposure of the active ingredient. non-GLP study with Wistar rats, test ammonium formate was seen in the Second, the conservatism of this animals were exposed to sodium toxicity databases. Therefore, no acute methodology is compounded by EPA’s formate at a concentration of 1% (274 risk from exposure to ammonium decision to assume that, for each mg/kg/day) for 18 months. No formate is expected and an acute commodity, the active ingredient which neoplasias were observed. Based on lack exposure assessment is not needed. will serve as a guide to the potential of mutagenicity and no evidence of ii. Chronic exposure. In conducting level of inert ingredient residues is the carcinogenicity on surrogate chemicals, the chronic dietary exposure active ingredient with the highest EPA concluded that the ammonium assessment, EPA used food tolerance level. This assumption formate is not expected to be consumption information from the overstates residue values because it carcinogenic. United States Department of Agriculture would be highly unlikely, given the Ammonium formate breaks down into (USDA) (1994–1996 and 1998) high number of inert ingredients, that a ammonium and formate ions. Nationwide Continuing Surveys of Food single inert ingredient or class of Ammonium ions are ubiquitous in the Intake by Individuals (CSFII). As to ingredients would be present at the natural environment and can be residue levels in food, no residue data level of the active ingredient in the considered as having little toxicity or were submitted for ammonium formate. highest tolerance for every commodity. hazard risk. Formate, as noted in the In the absence of specific residue data, Finally, a third compounding above toxicity discussion, is not EPA has developed an approach which conservatism is EPA’s assumption that excessively toxic. Formate ions are uses surrogate information to derive all foods contain the inert ingredient at

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the highest tolerance level. In other There are no known or anticipated compounds, since methanol is words, EPA assumed 100% of all foods residential uses and therefore, metabolized into formic acid. Therefore, are treated with the inert ingredient at residential exposure is not expected. the database is considered adequate for the rate and manner necessary to 4. Cumulative effects from substances FQPA assessment. produce the highest residue legally with a common mechanism of toxicity. ii. There is no evidence of increased possible for an active ingredient. In Section 408(b)(2)(D)(v) of FFDCA susceptibility of infants and children in summary, EPA chose a very requires that, when considering whether the available reproduction and conservative method for estimating to establish, modify, or revoke a developmental toxicity studies with what level of inert residue could be on tolerance, the Agency consider calcium formate and/or sodium formate. food, and then used this methodology to ‘‘available information’’ concerning the No developmental or maternal systemic choose the highest possible residue that cumulative effects of a particular toxicity was observed in rats at doses up could be found on food and assumed pesticide’s residues and ‘‘other to 200 mg/kg/day when calcium formate that all food contained this residue. No substances that have a common was administered via drinking water. consideration was given to potential mechanism of toxicity.’’ No developmental or maternal toxicity degradation between harvest and EPA has not found ammonium was observed in mice at doses up to 750 consumption even though monitoring formate to share a common mechanism mg/kg gavage dose of sodium formate on data show that tolerance level residues of toxicity with any other substances, gestation day 8. No evidence of are typically one to two orders of and ammonium formate does not appear increased susceptibility was observed magnitude higher than actual residues to produce a toxic metabolite produced following pre- and post-natal exposure in food when distributed in commerce. by other substances. For the purposes of to calcium formate. In a multi- Accordingly, although sufficient this tolerance action, therefore, EPA has generation reproduction study (3 to 5 information to quantify actual residue assumed that ammonium formate does generations), no parental, reproductive levels in food is not available, the not have a common mechanism of or offspring toxicity was observed at compounding of these conservative toxicity with other substances. For doses up to 200 mg/kg/day. assumptions will lead to a significant information regarding EPA’s efforts to iii. No neurotoxicity studies are exaggeration of actual exposures. EPA determine which chemicals have a available in the database. However, common mechanism of toxicity and to there is no evidence of clinical signs of does not believe that this approach evaluate the cumulative effects of such neurotoxicity in the database, nor underestimates exposure in the absence chemicals, see EPA’s website at http:// evidence of susceptibility in the young of residue data. www.epa.gov/pesticides/cumulative. in the database. Therefore, EPA iii. Cancer. Ammonium formate is not concluded that the developmental expected to be carcinogenic, since there D. Safety Factor for Infants and neurotoxicity study is not required. was no evidence of carcinogenicity in Children There is no evidence of immunotoxicity the available studies. The Persistent, Section 408(b)(2)(C) of FFDCA in the available database. Bioaccumulative, and Toxic (PBT) provides that EPA shall apply an iv. The dietary food exposure profiler, a component of the Agency’s additional tenfold (10X) margin of safety assessment utilizes highly conservative P2 Framework did not raise any cancer for infants and children in the case of default assumptions that would not concerns. Since the Agency has not threshold effects to account for pre-natal underestimate the dietary risk to all identified any concerns for and post-natal toxicity and the populations. For the purpose of the carcinogenicity relating to ammonium completeness of the database on toxicity screening level dietary risk assessment formate, a cancer dietary exposure and exposure unless EPA determines to support this request for an exemption assessment is not necessary to assess based on reliable data that a different from the requirement of a tolerance for cancer risk. margin of safety will be safe for infants ammonium formate, a value of 100 ppb 2. Dietary exposure from drinking and children. This additional margin of for drinking water based on screening water. For the purpose of the screening safety is commonly referred to as the level modeling was used for the chronic level dietary risk assessment to support FQPA Safety Factor (SF). In applying dietary risk assessment. The value of this request for an exemption from the this provision, EPA either retains the 100 ppb is considered to be a high end, requirement of a tolerance for default value of 10X, or uses a different conservative assumption that is not ammonium formate, a conservative additional safety factor when reliable likely to underestimate drinking water drinking water concentration value of data available to EPA support the choice risks. 100 parts per billion (ppb) based on of a different factor. Taking into consideration the screening level modeling was used to EPA concluded that the FQPA safety available information, EPA concludes assess the contribution to drinking factor could be removed for ammonium the additional 10X FQPA safety factor water for the chronic dietary risk formate for the following reasons: can be reduced to 1X. assessments for parent compound. i. No toxicological studies were These values were directly entered into identified for ammonium formate in the E. Aggregate Risks and Determination of the dietary exposure model. The Agency publically available databases. However, Safety considers the value of 100 ppb to be a ammonium formate breaks down into Determination of safety section. EPA high end, conservative assumption that ammonium and formate ions. determines whether acute and chronic is not likely to underestimate drinking Ammonium ions are ubiquitous in the dietary pesticide exposures are safe by water risks. natural environment and can be comparing aggregate exposure estimates 3. From non-dietary exposure. The considered as having little toxicity or to the acute PAD (aPAD) and chronic term ‘‘residential exposure’’ is used in hazard risk. There is available data on PAD (cPAD). For linear cancer risks, this document to refer to non- formic acid and related formate EPA calculates the lifetime probability occupational, non-dietary exposure compounds (such as calcium, sodium of acquiring cancer given the estimated (e.g., textiles (clothing and diapers), and methyl formate), which can serve as aggregate exposure. Short-, carpets, swimming pools, and hard suitable surrogates for ammonium intermediate-, and chronic-term risks surface disinfection on walls, floors, formate. Studies conducted with are evaluated by comparing the tables). methanol are also applicable to formate estimated aggregate food, water, and

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residential exposure to the appropriate used as an inert ingredient (complexing entitled Consultation and Coordination PODs to ensure that an adequate MOE or fixing agent) in pesticide with Indian Tribal Governments (65 FR exists. formulations applied to growing crops. 67249, November 9, 2000) do not apply 1. Acute aggregate (food and drinking to this final rule. In addition, this final VII. Statutory and Executive Order water) risk. No adverse effect rule does not impose any enforceable Reviews attributable to a single exposure of duty or contain any unfunded mandate ammonium formate was seen in the This final rule establishes a tolerance as described under Title II of the toxicity databases. Therefore, under section 408(d) of FFDCA in Unfunded Mandates Reform Act of 1995 ammonium formate is not expected to response to a petition submitted to the (UMRA) (Public Law 104–4). pose an acute risk. Agency. The Office of Management and This action does not involve any 2. Chronic aggregate (food and Budget (OMB) has exempted these types technical standards that would require of actions from review under Executive drinking water) risk. A chronic aggregate Agency consideration of voluntary Order 12866, entitled Regulatory risk assessment takes into account consensus standards pursuant to section Planning and Review (58 FR 51735, exposure estimates from chronic dietary 12(d) of the National Technology October 4, 1993). Because this final rule consumption of food and drinking Transfer and Advancement Act of 1995 has been exempted from review under water. Using the exposure assumptions (NTTAA), Public Law 104–113, section Executive Order 12866, this final rule is discussed in this unit for chronic 12(d) (15 U.S.C. 272 note). exposure, the chronic dietary exposure not subject to Executive Order 13211, from food and water to ammonium entitled Actions Concerning Regulations VIII. Congressional Review Act formate is 9.6% of the cPAD for the U.S. That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May The Congressional Review Act, 5 population and 31.2% of the cPAD for U.S.C. 801 et seq., generally provides children 1–2 years old, the most highly 22, 2001) or Executive Order 13045, entitled Protection of Children from that before a rule may take effect, the exposed population subgroup. The agency promulgating the rule must chronic dietary exposure estimates for Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). submit a rule report to each House of food and drinking water are below the the Congress and to the Comptroller Agency’s level of concern (<100% This final rule does not contain any information collections subject to OMB General of the United States. EPA will cPAD) for the U.S. population and all submit a report containing this rule and population subgroups. There are no approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et other required information to the U.S. residential uses known or proposed, and Senate, the U.S. House of therefore, no residential exposure is seq., nor does it require any special considerations under Executive Order Representatives, and the Comptroller expected. General of the United States prior to 3. Aggregate cancer risk for U.S. 12898, entitled Federal Actions to Address Environmental Justice in publication of this final rule in the population. The Agency has not Federal Register. This final rule is not identified any concerns for Minority Populations and Low-Income Populations (59 FR 7629, February 16, a ‘‘major rule’’ as defined by 5 U.S.C. carcinogenicity relating to ammonium 1994). 804(2). formate. Since tolerances and exemptions that 4. Determination of safety. Based on are established on the basis of a petition List of Subjects in 40 CFR Part 180 these risk assessments, EPA concludes under section 408(d) of FFDCA, such as Environmental protection, that there is a reasonable certainty that the tolerance in this final rule, do not no harm will result to the general Administrative practice and procedure, require the issuance of a proposed rule, Agricultural commodities, Pesticides population or to infants and children the requirements of the Regulatory from aggregate exposure to ammonium and pests, Reporting and recordkeeping Flexibility Act (RFA) (5 U.S.C. 601 et requirements. formate residues. seq.) do not apply. V. Other Considerations This final rule directly regulates Dated: September 7, 2010. growers, food processors, food handlers, A. Analytical Enforcement Methodology Lois Rossi, and food retailers, not States or tribes, Director, Registration Division, Office of An analytical method is not required nor does this action alter the Pesticide Programs. for enforcement purposes since the relationships or distribution of power Agency is establishing an exemption and responsibilities established by ■ Therefore, 40 CFR chapter I is from the requirement of a tolerance Congress in the preemption provisions amended as follows: without any numerical limitation. of section 408(n)(4) of FFDCA. As such, the Agency has determined that this PART 180—[AMENDED] B. International Residue Limits action will not have a substantial direct ■ The Agency is not aware of any effect on States or tribal governments, 1. The authority citation for part 180 country requiring a tolerance for nor on the relationship between the national continues to read as follows: have any CODEX Maximum Residue government and the States or tribal Authority: 21 U.S.C. 321(q), 346a and 371. Levels (MRLs) been established for any governments, or on the distribution of ■ 2. In § 180.920, the table is amended food crops at this time. power and responsibilities among the by adding alphabetically the following various levels of government or between inert ingredient to read as follows: VI. Conclusions the Federal Government and Indian Therefore, an exemption from the tribes. Thus, the Agency has determined § 180.920 Inert ingredients used pre- requirement of a tolerance is established that Executive Order 13132, entitled harvest; exemptions from the requirement under 40 CFR 180.920 for ammonium Federalism (64 FR 43255, August 10, of a tolerance. formate (CAS Reg. No. 540–69–2) when 1999) and Executive Order 13175, * * * * *

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Inert ingredients Limits Uses

*** * * Ammonium formate (CAS Reg. No. 540–69–2) Complexing or fixing agent *** * *

[FR Doc. 2010–22976 Filed 9–14–10; 8:45 am] nursery, and floriculture workers; as the petition, were filed with EPA by BILLING CODE 6560–50–S farmers. NRDC. • Animal production (NAICS code NRDC’s original petition, dated 112), e.g., cattle ranchers and farmers, January 10, 2005, submitted to the ENVIRONMENTAL PROTECTION dairy cattle farmers, livestock farmers. carbaryl public docket during the public AGENCY • Food manufacturing (NAICS code comment period for the 2004 Amended 311), e.g., agricultural workers; farmers; Interim Reregistration Eligibility [EPA–HQ–OPP–2008–0347; FRL–8843–7] greenhouse, nursery, and floriculture Decision (IRED) for Carbaryl, and filed workers; ranchers; pesticide applicators. pursuant to FFDCA section 408(d)(1), 40 CFR Part 180 • Pesticide manufacturing (NAICS asserted a number of grounds why code 32532), e.g., agricultural workers; carbaryl tolerances allegedly fail to meet Carbaryl; Order Denying NRDC’s commercial applicators; farmers; the FFDCA’s safety standard. The main Objections and Requests for Hearing greenhouse, nursery, and floriculture arguments raised in the petition AGENCY: Environmental Protection workers; residential users. concerned EPA’s drinking water Agency (EPA). This listing is not intended to be assessment and EPA’s decision on the exhaustive, but rather to provide a guide ACTION: Order. statutory safety factor to protect infants for readers regarding entities likely to be and children that supported the 2004 SUMMARY: In this order, the affected by this action. Other types of IRED decision. NRDC also petitioned Environmental Protection Agency (EPA) entities not listed in this unit could also the Agency to cancel all carbaryl uses denies objections, and requests for be affected. The North American pursuant to the Federal Insecticide, hearing on those objections, to a prior Industrial Classification System Fungicide, and Rodenticide Act (FIFRA) order denying a petition requesting that (NAICS) codes have been provided to 7 U.S.C. 136(bb) and 136a, and argued EPA revoke all pesticide tolerances for assist you and others in determining unreasonable risks on the environment. carbaryl under section 408(d) of the whether this action might apply to Subsequently, on November 26, 2007, Federal Food, Drug, and Cosmetic Act. certain entities. If you have any NRDC petitioned EPA to cancel all The objections and hearing requests questions regarding the applicability of carbaryl pet collar uses under FIFRA. were filed on December 29, 2008, by the this action to a particular entity, consult (Ref. 3). EPA consolidated this latter Natural Resources Defense Council the person listed under FOR FURTHER petition with the 2005 FFDCA petition (NRDC). The original petition was also INFORMATION CONTACT. because NRDC argued in it that filed by NRDC. B. How Can I Get Copies of this exposure to carbaryl pet collars make FOR FURTHER INFORMATION CONTACT: Document and Other Related the risks presented by carbaryl unsafe Jacqueline Guerry, Pesticide Re- Information? within the meaning of FFDCA section evaluation Division (7508P), Office of 408. EPA has established a docket for this On October 29, 2008, EPA responded Pesticide Programs, Environmental action under docket identification (ID) Protection Agency, 1200 Pennsylvania to both the 2005 petition to revoke all number EPA–HQ–OPP–2008–0347. carbaryl tolerances and the 2007 Ave., NW., Washington, DC 20460– Publicly available docket materials are 0001; telephone number: (215) 814– petition to cancel all pet collar uses, available either in the electronic docket denying them in their entirety. (73 FR 2184; e-mail address: at http://www.regulations.gov, or, if only [email protected]. 64229, October 29, 2008) (Ref. 4). available in hard copy, at the Office of NRDC then filed objections to EPA’s SUPPLEMENTARY INFORMATION: Pesticide Programs (OPP) Regulatory denial of NRDC’s petition to revoke all Public Docket in Rm. S–4400, One I. General Information carbaryl tolerances and requested a Potomac Yard (South Bldg.), 2777 S. hearing on its objections. These A. Does this Action Apply to Me? Crystal Dr., Arlington, VA. The hours of objections and hearing requests were In this document, EPA denies operation of this Docket Facility are filed pursuant to the procedures in the objections, and requests for hearing on from 8:30 a.m. to 4 p.m., Monday FFDCA, section 408(g)(2). (21 U.S.C. those objections, submitted by NRDC in through Friday, excluding legal 346a(g)(2)). The objections narrowed response to a prior order denying holidays. The Docket Facility telephone NRDC’s claims to two main topics – that NRDC’s petition requesting that EPA number is (703) 305–5805. EPA lacks reliable data to reduce the revoke all pesticide tolerances for II. Introduction Food Quality Protection Act (FQPA) carbaryl. In addition to NRDC, and Children’s Safety Factor and that EPA’s others interested in food safety issues A. What Action Is the Agency Taking? exposure assessment for carbaryl is generally, this action may be of interest In this order, EPA denies objections, flawed and underestimates the exposure to agricultural producers, food and requests for a hearing on those to children from pet collar uses. After manufacturers, or pesticide objections, to an earlier EPA Order, (73 carefully reviewing the objections and manufacturers. Potentially affected FR 64229 ), denying a petition to revoke hearing requests, EPA has determined entities may include, but are not limited all tolerances established for the that NRDC’s hearing requests do not to those engaged in the following pesticide, carbaryl, under the Federal satisfy the regulatory requirements for activities: Food, Drug, and Cosmetic Act (FFDCA), such requests and that its substantive • Crop production (NAICS code 111), 21 U.S.C. 346a, (Refs. 1 and 2). Both the objections are without merit. Therefore, e.g., agricultural workers; greenhouse, objections and hearing requests, as well EPA, in this final order, denies NRDC’s

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