美国制定碳酸二正丁酯残留限量要求（Di-n-butyl carbonate; Exemption From the Requirement of a Tolerance）_中国食品网

【发布单位】 EPA
【发布文号】
【发布日期】 2015-06-15
【生效日期】 2015-06-15
【废止日期】
【替代法规】
【效　　力】
【食品伙伴网解读】 2015年6月15日,美国EPA发布一项最终规则，规定碳酸二正丁酯作为农药制剂的惰性成分一起用于农作物、收获后未加工农产品，以及作为食品接触表面卫生洗涤剂产品的抗微生物制剂中的惰性成分使用时，最大浓度为15000 ppm。

　　ACTION

　　Final Rule.

　　SUMMARY

　　This regulation establishes an exemption from the requirement of a tolerance for residues of di-n-butyl carbo nate (CAS Reg. No. 542-52-9) when used as an inert ingredient (solvent) in pesticide formulations applied to growing crops, raw agricultural commodities after harvest, and animals, and when used as an inert ingredient in antimicrobial pesticide formulations in food-co ntact surfaces sanitizer products at a maximum levelin the end-use co ncentration of 15,000 ppm (1.5%). Expo nent Inc., on behalf of Huntsman Corp., submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of di-n-butyl carbonate.

　　TABLE OF CONTENTS

　　DATES:

　　ADDRESSES:

　　FOR FURTHER INFORMATION CONTACT:

　　SUPPLEMENTARY INFORMATION:

　　I. General Information

　　A. Does this action apply to me?

　　B. How can I get electro nic access to other related information?

　　C. How can I file an objection or hearing request?

　　II. Petition for Exemption

　　III. Inert Ingredient Definition

　　IV. Aggregate Risk Assessment and Determination of Safety

　　A. Toxicological Profile

　　B. Toxicological Points of Departure/Levels of Concern

　　C. Exposure Assessment

　　D. Safety Factor for Infants and Children

　　E. Aggregate Risks and Determination of Safety

　　V. Other Considerations

　　A. Analytical Enforcement Methodology

　　VI. Conclusions

　　VII. Statutory and Executive Order Reviews

　　VIII. Co ngressional Review Act

　　List of Subjects in 40 CFR Part 180

　　PART 180—[AMENDED]

　　DATES:

　　This regulation is effective June 15, 2015. Objections and requests for hearings must be received on or before August 14, 2015, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

　　ADDRESSES:

　　The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2014-0176, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Enviro nmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Co nstitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Mo nday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additio nal information a bout the docket available at http://www.epa.gov/dockets.

　　FOR FURTHER INFORMATION CONTACT:

　　Susan Lewis, Director, Registration Division (7505P), Office of Pesticide Programs, Enviro nmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address: RDFRNotices@epa.gov.

　　SUPPLEMENTARY INFORMATION:

　　I. General Information

　　A. Does this action apply to me?

　　You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this docu ment applies to them. Potentially affected entities may include:

　　Crop production (NAICS code 111).

　　Animal production (NAICS code 112).

　　Food manufacturing (NAICS code 311).

　　Pesticide manufacturing (NAICS code 32532).

　　B. How can I get electro nic access to other related information?

　　You may access a frequently updated electro nic version of 40 CFR part 180 through the Government Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP test guidelines referenced in this docu ment electronically, please go to http://www.epa.gov/ocspp and selec “Test Methods and Guidelines.”

　　C. How can I file an objection or hearing request?

　　Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2014-0176 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before August 14, 2015. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

　　In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Co nfidential Business Information (CBI)) for inclusion in the public docket. Information not marked co nfidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2014-0176, by one of the following methods:

　　Federal eRulemaking Portal: http://www.regulations.gov. Follow the o nline instructions for submitting comments. Do not submit electro nically any information you co nsider to be CBI or other information whose disclosure is restricted by statute.

　　Mail: OPP Docket, Enviro nmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

　　Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html. Additio nal instructions on commenting or visiting the docket, along with more information a bout dockets generally, is available at http://www.epa.gov/dockets.

　　II. Petition for Exemption

　　In the Federal Register of January 28, 2015 (80 FR 4525) (FRL-9921-55), EPA issued a docu ment pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-10683) by Expo nent Inc., 1150 Co nnecticut Ave. NW., Suite 1100, Washington, DC 20036, on behalf of Huntsman Corporation, 8600 Gosling Road, The Woodlands, TX 77381. The petition requested that 40 CFR 180.910, 180.930, and 180.940 be amended by establishing an exemption from the requirement of a tolerance for residues of di-n-butyl carbo nate (CAS Reg. No. 542-52-9) when used as an inert ingredient (solvent) in pesticide formulations applied to growing crops, raw agricultural commodities after harvest, and animals, and when used as an inert ingredient in antimicrobial formulations in food-co ntact surface sanitizer products. That docu ment referenced a summary of the petition prepared by Expo nent Inc., on behalf of Huntsman Corp., the petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in respo nse to the notice of filing.

　　ba sed on a review of the data submitted in support of this petition, EPA has modified the exemption requested by limiting the amount of di-n-butyl carbo noate allowed in food co ntact sanitizing solutions to a maximum 15,000 ppm (1.5%). This limitation is ba sed on the Agency's risk assessment which can be found at http://www.regulations.gov in docu ment “Di-n-Butyl Carbonate; Human Health Risk Assessment and Ecological Effects Assessment to Support Proposed Exemption from the Requirement of a Tolerance When Used as an Inert Ingredient in Pesticide Formulations,” in docket ID number EPA-HQ-OPP-2014-0176.

　　III. Inert Ingredient Definition

　　Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents;and emulsifiers. The term “inert” is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance ba sed on the low toxicity of the individual inert ingredients.

　　IV. Aggregate Risk Assessment and Determination of Safety

　　Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) o nly if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reaso nable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupatio nal exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special co nsideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reaso nable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”

　　EPA establishes exemptions from the requirement of a tolerance o nly in those cases wher it can be clearly demo nstrated that the risks from aggregate exposure to pesticide chemical residues under reaso nably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency co nsiders the toxicity of the inert in co njunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reaso nable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.

　　Co nsistent with FFDCA section 408(c)(2)(A), and the factors specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for di-n-butyl carbo nate including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with di-n-butyl carbo nate follows.

　　A. Toxicological Profile

　　EPA has e valuated the available toxicity data and co nsidered their validity, completeness, and reliability as well as the relatio nship of the results of the studies to human risk. EPA has also co nsidered available information co ncerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by di-n-butyl carbo nate as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in this unit.

　　Di-n-butyl carbo nate acute toxicity testing indicate that it has low acute oral, dermal and inhalation toxicity (acute oral and dermal LD 50> 2,000 milligrams/kilogram (mg/kg); acute inhalation LC 50>8 mg/Liter (mg/L) and is non-irritating to the eyes and negative for dermal sensitization. Di-n-butyl carbo nate is irritating to the skin. In a combined repeated dose toxicity study with the reproductive and developmental toxicity screening test, di-n-butyl carbo nate was administered daily to rats by gavage. The di-n-butyl carbo nate test material did not result in any test material related mortality or clinical observations in the parental animals. No effects were observed in the functio nal observatio nal battery, hematology and clotting parameters, clinical chemistry parameters, or organ weights. No macroscopic findings related to the test item were observed. No histopathological effects were reported in neurological tissues (cerebrum, cerebellum, pons, peripheral nerve, spinal cord) (cervical, midthoracic and lumbar sections) or any immunological tissues (bone marrow, thymus, spleen, lymph nodes).

　　The NOAEL of di-n-butyl carbo nate in rats is 500 mg/kg bw/day for parental animals (males and females) and 500 mg/kg bw/day for embryo-fetal toxicity. The LOAEL is 750 mg/kg bw/day ba sed on decreased body weight gain in male and female paternal animals and embryo-fetal toxicity at 750 mg/kg bw/day as evidenced by increased pre- and post-implantation losses and decreased total number of pups.

　　If ingested di-n-butyl carbo nate would be readily hydrolyzed by esterases in the gut to generate two molar equivalents of n-butanol and one molar equivalent of carbo nic acid. EPA has stated for the n-butanol tolerance reassessment that o nce absorbed, n-butanol disappears rapidly from the blood. The carbo nic acid rapidly dissociates into CO 2 and water.

　　Di-n-butyl carbo nate was negative in an OCSPP Harmo nized Test Guideline Bacterial Reverse Mutation Assay (at co ncentrations ranging from 1.5 to 5,000 ug per plate); no positive mutagenic respo nse was observed.

　　There are no carcinogenicity studies available for di-n-butyl carbonate. ba sed on predicted rapid me tabolism and excretion, the lack of specific target organ toxicity in the OCSPP Harmo nized Test Guideline 870.3650 study, the results of genotoxicity testing being negative, and a Quantitative Structure Activity Relatio nship (QSAR) expert model, DEREK Nexus, that indicates no structural a lerts for carcinogenicity, di-n-butyl carbo nate is not expected to be carcinogenic.

　　B. Toxicological Points of Departure/Levels of Concern

　　o nce a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of co ncern to use in e valuating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed ba sed on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of co ncern are identified (the LOAEL). Uncertainty/safety factors are used in co njunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete des cription of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.

　　No acute toxicological endpoints have been identified for di-n-butyl carbonate; therefore no acute exposure assessments are warranted.

　　The overall NOAEL for di-n-butyl carbo nate was established at 500 mg/kg/day. The chro nic risk assessment for di-n-butyl carbo nate is ba sed on this endpoint and the chro nic reference dose (cRfD) is therefore 5.0 mg/kg/day. The cRfD incorporates a 10X interspecies factor and a 10X intraspecies factor. Since the FQPA SF has been reduced to 1X, the cPAD is also 5.0 mg/kg/day.

　　C. Exposure Assessment

　　1. Dietary exposure from food and feed uses. In e valuating dietary exposure to di-n-butyl carbonate, EPA co nsidered exposure under the proposed exemption from the requirement of a tolerance. EPA assessed dietary exposures from di-n-butyl carbo nate in food as follows:

　　The Agency assessed the dietary exposures to di-n-butyl carbo nate as an inert ingredient for use in pesticide formulations applied to growing crops, raw agricultural commodities, and livestock, as well as an inert ingredient for use in food-co ntact surface sanitizing solutions. In the case of dietary exposures to di-n-butyl carbo nate as an inert ingredient used in pesticide formulations applied to growing crops, raw agricultural commodities, and livestock, a chro nic dietary exposure assessment was co nducted using the Dietary Exposure e valuation Model/Food Commodity Intake Databa se (DEEM-FCID) TM, Version 3.16. EPA used food co nsumption information from the U.S. Department of Agriculture's Natio nal Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). This dietary survey was co nducted from 2003 to 2008. As to residue levels in food, no residue data were submitted for di-n-butyl carbonate. In the absence of specific residue data, EPA has developed an approach which uses surrogate information to derive upper bound exposure estimates for the subject inert ingredient. Upper bound exposure estimates are ba sed on the highest tolerance for a given commodity from a list of high-use insecticides, herbicides, and fungicides. A complete des cription of the general approach taken to assess inert ingredient risks in the absence of residue data is co ntained in the memorandum entitled “Alkyl Amines Polyalkoxylates (Cluster 4): Acute and Chro nic Aggregate (Food and Drinking Water) Dietary Exposure and Risk Assessments for the Inerts.” (D361707, S. Piper, 2/25/09) and can be found at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2008-0738.

　　In the case of the proposed use of di-n-butyl carbo nate as an inert ingredient in food-co ntact sanitizing pesticide products, EPA has utilized a conservative, health-protective method of estimating dietary intake that is ba sed upon co nservative assumptions related to the amount of residues that can be transferred to foods as a result of the proposed use. This same methodology has been utilized by EPA in estimating dietary exposures to antimicrobial pesticides used in food-handling settings. A complete des cription of the approach used to assess dietary exposures resulting from food co ntact sanitizing solution uses of di-n-butyl carbo nate can be found at http://www.regulations.gov in docu ment “Di-n-Butyl Carbonate; Human Health Risk Assessment and Ecological Effects Assessment to Support Proposed Exemption from the Requirement of a Tolerance When Used as an Inert Ingredient in Pesticide Formulations,” pp. 12-23 in docket ID number EPA-HQ-OPP-2014-0176.

　　The exposures from food and food co ntact sanitizing are then added together for the final dietary exposure assessment.

　　2. Dietary exposure from drinking water. For the purpose of the screening level dietary risk assessment to support this request for an exemption from the requirement of a tolerance for di-n-butyl carbonate, a co nservative drinking water co ncentration value of 100 parts per billions (ppb) ba sed on screening level modeling was used to assess the co ntribution to drinking water for the chro nic dietary risk assessments for parent compound. These values were directly entered into the dietary exposure model.

　　3. From non-dietary exposure. The term “residential exposure” is used in this docu ment to refer to non-occupational, non-dietary exposure (e.g., textiles (clothing and diapers), carpets, swimming pools, and hard surface disinfection on walls, floors, tables).

　　There are no current or proposed residential uses for di-n-butyl carbonate; however, it is possible that di-n-butyl carbo nate may be used as an inert ingredient in pesticide products. A highly co nservative residential exposure assessment was performed in which it was assumed that all residential use pesticide products would co ntain di-n-butyl carbo nate as an inert ingredient. A complete des cription of the approach used to assess possible residential exposures from di-n-butyl carbo nate can be found in http://www.regulations.gov in docu ment “Di-n-Butyl Carbonate; Human Health Risk Assessment and Ecological Effects Assessment to Support Proposed Exemption from the Requirement of a Tolerance When Used as an Inert Ingredient in Pesticide Formulations,” pp. 16 in docket ID number EPA-HQ-OPP-2014-0176.

　　4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when co nsidering whether to establish, modify, or revoke a tolerance, the Agency co nsider “available information” co ncerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

　　EPA has not found di-n-butyl carbo nate to share a common mechanism of toxicity with any other substances, and di-n-butyl carbo nate does not appear to produce a toxic me tabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that di-n-butyl carbo nate does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to e valuate the cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

　　D. Safety Factor for Infants and Children

　　1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additio nal tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the databa se on toxicity and exposure unless EPA determines ba sed on reliable data that a different margin of safety will be safe for infants and children. This additio nal margin of safety is commo nly referred to as the FQPA Safety Factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additio nal safety factor when reliable data available to EPA support the choice of a different factor.

　　2. Prenatal and postnatal sensitivity. There is evidence for qualitative susceptibility in the OECD 422 study. In this study, embryo-fetal toxicity was manifested as evidenced by increased pre- and post-implantation losses and decreased total number of pups in the presence of maternal toxicity (decreased in body weights). However, co nsidering the overall toxicity profile and the toxicity endpoints and doses seleced for di-n-butyl carbonate, the degree of co ncern for the effects observed in the di-n-butyl carbo nate reproductive and developmental toxicity screening studyis low. There is a clear NOAEL for the offspring effects, and endpoints and regulatory doses were selected for use in the dietary risk assessment to be protective of these effects.

　　3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is ba sed on the following findings:

　　i. The toxicity databa se for di-n-butyl carbo nate summarize the studies included in the databa se. EPA co ncludes that these data are sufficient for assessing the effects of di-n-butyl carbo nate on infants and children.

　　ii. There is no indication that di-n-butyl carbo nate is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additio nal UFs to account for neurotoxicity.

　　iii. Although there is some evidence that di-n-butyl carbo nate results in increased susceptibility in rats, the degree of co ncern for these effects is low for the reasons explained in Unit IV.D.2.

　　iv. There are no residual uncertainties identified in the exposure databa ses. The dietary food exposure assessments were performed ba sed on 100% CT and tolerance-level residues as well as co nservative assumptions regarding exposures from food-co ntact sanitizer uses. EPA made co nservative (protective) assumptions in the ground and surface water modeling used to assess exposure to di-n-butyl carbo nate in drinking water. These assessments will not underestimate the exposure and risks posed by di-n-butyl carbonate.

　　E. Aggregate Risks and Determination of Safety

　　1. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary co nsumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was seleced. Therefore, di-n-butyl carbo nate is not expected to pose an acute risk.

　　2. Chro nic risk. Using the exposure assumptions described in this unit for chro nic exposure, EPA has co ncluded that chro nic exposure to di-n-butyl carbo nate from food and water will utilize 21% of the cPAD for the U.S. population and 94% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure.

　　3. Short- and Intermediate-term risk. Short- and intermediate-term aggregate exposure takes into account short- and intermediate-term residential exposure plus chro nic exposure to food and water (co nsidered to be a background exposure level). While di-n-butyl carbo nate is not currently used as an inert ingredient in pesticide products that are registered for uses that could result in short- or intermediate-term residential exposure, it is possible that di-n-butyl carbo nate could be used in such products and the Agency has determined that it is appropriate to aggregate chro nic exposure through food and water with potential short-and intermediate-term residential exposures to n-butyl benzoate.

　　Using the exposure assumptions described in this unit for short-and intermediate-term exposures, EPA has co ncluded the combined food, water, and residential exposures result in aggregate short- and intermediate-term MOEs of 320 for adults and 100 for children (1-2 years old). EPA's level of co ncern for n-butyl benzoate is a MOE of 100 or below; however, these MOEs are not of co ncern ba sed on the highly co nservative assumptions made regarding residential and dietary exposures to n-butyl benzoate.

　　4. Aggregate cancer risk for U.S. population. As discussed in Unit IV.A., di-n-butyl carbo nate is not expected to pose a cancer risk to humans.

　　5. Determination of safety. ba sed on these risk assessments, EPA co ncludes that there is a reaso nable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to di-n-butyl carbo nate residues.

　　V. Other Considerations

　　A. Analytical Enforcement Methodology

　　An analytical method for enforcement purposes is not required for di-n-butyl carbo nate in pesticide formulations which include uses on crops for pre- and post-harvest, and on animals, since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation.

　　An analytical method is also not required for enforcement purposes for di-n-butyl carbo nate on food-co ntact surfaces in antimicrobial applications since the Agency is not establishing a numerical tolerance for residues of di-n-butyl carbo nate in or on any food commodities. EPA is establishing a limitation on the amount of di-n-butyl carbo nate that may be used in food-co ntact surface antimicrobial applications. That limitation will be enforced through the pesticide registration process under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”), 7 U.S.C. 136 et seq. EPA will not register any food-co ntact surface antimicrobial applications for sale or distribution that co ntains greater than 15,000 ppm (1.5%) of di-n-butyl carbo nate by weight.

　　VI. Conclusions

　　Therefore, exemptions from the requirement of a tolerance is established under 40 CFR 180.910, 180.930, and 180.940(a) for di-n-butyl carbo nate (CAS Reg. No. 542-52-9) when used as an inert ingredient (solvent) in pesticide formulations applied to growing crops, raw agricultural commodities after harvest, and animals, and when used as an inert ingredient in antimicrobial formulations in food-co ntact surface sanitizer products at a maximum level in the end-use co ncentration of 15,000 ppm.