PMEP Home Page --> Pesticide Active Ingredient Information --> Fungicides and Nematicides --> Acetic acid to Etridiazole --> carboxin (Vitavax) --> carboxin (Vitavax) Pesticide Tolerances for Emergency Exemptions 1/97

carboxin (Vitavax) Pesticide Tolerances for Emergency Exemptions 1/97

>ENVIRONMENTAL PROTECTION AGENCY

>40 CFR Part 180

>[OPP-300450; FRL-5584-5]
>RIN 2070-AB78


>Carboxin; Pesticide Tolerances for Emergency Exemptions 

>AGENCY: Environmental Protection Agency (EPA). 

>ACTION: Final rule.

>----------------------------------------------------------------------- 

>SUMMARY: This regulation establishes a time-limited tolerance for combined residues of the fungicide carboxin in or on the raw agricultural commodity onion seed in connection with EPA's granting of emergency exemptions under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act authorizing use of carboxin on onion seed in California and New Jersey. This regulation establishes a maximum permissible level for residues of carboxin in this food pursuant to section 408(l)(6) of the Federal Food, Drug and Cosmetic Act, as amended by the Food Quality Protection Act of 1996. This tolerance will expire and be revoked automatically without further action by EPA on January 17, 1998.
>DATES: This regulation becomes effective February 3, 1997. This regulation expires and is revoked automatically without further action by EPA on January 17, 1998. Objections and requests for hearings must be received by EPA on April 4, 1997.

>ADDRESSES: Written objections and hearing requests, identified by the docket number, [OPP-300450], must be submitted to: Hearing Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St., SW., Washington, DC 20460. Fees accompanying objections and hearing requests shall be labeled ``Tolerance Petition Fees'' and forwarded to: EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees), P.O. Box 360277M, Pittsburgh, PA 15251.
>A copy of any objections and hearing requests filed with the Hearing Clerk identified by the docket number, [OPP-300450], should be submitted to: Public Response and Program Resources Branch, Field Operations Division (7506C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. In person, bring a copy of objections and hearing requests to Rm. 1132, CM #2, 1921 Jefferson Davis Highway, Arlington, VA. 
>A copy of objections and hearing requests filed with the Hearing Clerk may also be submitted electronically by sending electronic mail (e-mail) to: opp-docket@epamail.epa.gov. Copies of objections and hearing requests must be submitted as an ASCII file avoiding the use of special characters and any form of encryption. Copies of objections and hearing requests will also be accepted on disks in WordPerfect 5.1 file format or ASCII file format. No Confidential Business Information (CBI) should be submitted through e-mail. Electronic copies of objections and hearing requests on this rule may be filed online at many Federal Depository Libraries.

>FOR FURTHER INFORMATION CONTACT: By mail: Stephen Schaible, Registration Division (7505W), Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. Office location, telephone number, and e-mail address: Sixth Floor, Crystal Station #1, 2800 Jefferson Davis Highway, Arlington, VA 22202, (703) 308-8337, e-mail: schaible.stephen@epamail.epa.gov.
>SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to section 408(e) and (l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e) and (l)(6), is establishing a tolerance for residues of the fungicide carboxin, 5,6-dihydro-2-methyl-1,4-oxathiin- 3-carboxanilide in or on onions (dry bulb) at 0.2 part per million (ppm). This tolerance will expire and be revoked automatically without further action by EPA on January 17, 1998. 

>I. Background and Statutory Authority

>The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170) was signed into law August 3, 1996. FQPA amends both the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301 et seq., and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. The FQPA amendments went into effect immediately. Among other things, FQPA amends FFDCA to bring all EPA pesticide tolerance-setting activities under a new section 408 with a new safety standard and new procedures. These activities were discussed in detail in the final rule establishing a tolerance for an emergency exemption for use of propiconazole on sorghum (61 FR 58135, Nov. 13, 1996). 
>New section 408(b)(2)(A)(i) allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.'' This includes exposure through drinking water, but does not include occupational exposure. Section 408(b)(2)(C) requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ``ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....'' Section 18 of FIFRA authorizes EPA to exempt any Federal or State agency from any provision of

>[[Page 4912]]

>FIFRA, if EPA determines that ``emergency conditions exist which require such exemption.'' This provision was not amended by FQPA. EPA has established regulations governing such emergency exemptions in 40 CFR part 166.
>Section 408(l)(6) requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under section 18 of FIFRA. Section 408(l)(6) also requires EPA to promulgate regulations by August 3, 1997, governing the establishment of tolerances and exemptions under section 408(l)(6) and requires that the regulations be consistent with section 408(b)(2) and (c)(2) and FIFRA section 18. 
>Section 408(l)(6) allows EPA to establish tolerances or exemptions from the requirement for a tolerance, in connection with EPA's granting of FIFRA section 18 emergency exemptions, without providing notice or a period for public comment. Thus, consistent with the need to act expeditiously on requests for emergency exemptions under FIFRA, EPA can establish such tolerances or exemptions under the authority of section 408(e) and (l)(6) without notice and comment rulemaking. 
>In establishing section 18-related tolerances and exemptions during this interim period before EPA issues the section 408(l)(6) procedural regulation and before EPA makes its broad policy decisions concerning the interpretation and implementation of the new section 408, EPA does not intend to set precedents for the application of section 408 and the new safety standard to other tolerances and exemptions. Rather, these early section 18 tolerance and exemption decisions will be made on a case-by-case basis and will not bind EPA as it proceeds with further rulemaking and policy development. EPA intends to act on section 18- related tolerances and exemptions that clearly qualify under the new law.

>II. Emergency Exemption for Carboxin on Onion Seed and FFDCA Tolerances

>The California Department of Pesticide Regulations and the New Jersey Department of Environmental Protection requested specific exemptions for use of carboxin on onion seed to control onion smut. The loss of Arasan 50 Red, the fungicide historically used to control onion smut, has resulted in an urgent, non-routine situation for growers. In the past, onion smut was controlled with thiram 50 percent wettable powder (Arasan 50 Red) seed treatments. However, the DuPont Company ceased manufacture of this product in 1985, and growers have since exhausted existing stocks of Arasan 50 Red. According to the Applicants, there are no other registered pesticides or alternative practices available that will control this disease. There are other thiram products registered for use as onion seed treatments, but the maximum label rates are too low to control onion smut. 
>As part of its assessment of this application for an emergency exemption, EPA assessed the potential risks presented by residues of carboxin on onion seed. In doing so, EPA considered the new safety standard in FFDCA section 408(b)(2), and EPA decided to grant the section 18 exemption only after concluding that the necessary tolerance under FFDCA section 408(l)(6) would be consistent with the new safety standard and with FIFRA section 18. This tolerance for carboxin will permit the marketing of onion seed treated in accordance with the provisions of the section 18 emergency exemptions. Consistent with the need to move quickly on the emergency exemptions and to ensure that the resulting food is safe and lawful, EPA is issuing this tolerance without notice and opportunity for public comment under section 408(e) as provided in section 408(l)(6). Although this tolerance will expire and be revoked automatically without further action by EPA on December 31, 1997, under FFDCA section 408(l)(5), residues of carboxin not in excess of the amount specified in the tolerance remaining in or on onion seeds after that date will not be unlawful, provided the pesticide is applied during the term of, and in accordance with all the conditions of, the emergency exemptions. EPA will take action to revoke this tolerance earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.
>EPA has not made any decisions about whether carboxin meets the requirements for registration under FIFRA section 3 for use on onion seeds or whether a permanent tolerance for carboxin for onion seeds would be appropriate. This action by EPA does not serve as a basis for registration of carboxin by a State for special local needs under FIFRA section 24(c). Nor does this action serve as the basis for any States other than California to use this product on this crop under section 18 of FIFRA without following all provisions of section 18 as identified in 40 CFR part 166. For additional information regarding the emergency exemptions for carboxin, contact the Agency's Registration Division at the address provided above.

>III. Risk Assessment and Statutory Findings 

>EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of pesticides based primarily on toxicological studies using laboratory animals. These studies address many adverse health effects, including (but not limited to) reproductive effects, developmental toxicity, toxicity to the nervous system, and carcinogenicity. For many of these studies, a dose response relationship can be determined, which provides a dose that causes adverse effects (threshold effects) and doses causing no observed effects (the ``no-observed effect level'' or ``NOEL'').
>Once a study has been evaluated and the observed effects have been determined to be threshold effects, EPA generally divides the NOEL from the study with the lowest NOEL by an uncertainty factor (usually 100 or more) to determine the Reference Dose (RfD). The RfD is a level at or below which daily aggregate exposure over a lifetime will not pose appreciable risks to human health. An uncertainty factor (sometimes called a ``safety factor'') of 100 is commonly used since it is assumed that people may be up to 10 times more sensitive to pesticides than the test animals, and that one person or subgroup of the population (such as infants and children) could be up to 10 times more sensitive to a pesticide than another. In addition, EPA assesses the potential risks to infants and children based on the weight of the evidence of the toxicology studies and determines whether an additional uncertainty factor is warranted. Thus, an aggregate daily exposure to a pesticide residue at or below the RfD (expressed as 100 percent or less of the RfD) is generally considered by EPA to pose no appreciable risk. 
>Lifetime feeding studies in two species of laboratory animals are conducted to screen pesticides for cancer effects. When evidence of increased cancer is noted in these studies, the Agency conducts a weight of the evidence review of all relevant toxicological data including short term and mutagenicity studies and structure activity relationship. Once a pesticide has been classified as a potential human carcinogen, different types of risk assessments (e.g., linear low dose 

>[[Page 4913]]

>extrapolations or margin of exposure calculation based on the appropriate NOEL) may be carried out based on the nature of the carcinogenic response and the Agency's knowledge of its mode of action. 
>In examining aggregate exposure, FFDCA section 408 requires that EPA take into account available and reliable information concerning exposure from the pesticide residue in the food in question, residues in other foods for which there are tolerances, and other non- occupational exposures, such as where residues leach into groundwater or surface water that is consumed as drinking water. Dietary exposure to residues of a pesticide in a food commodity are estimated by multiplying the average daily consumption of the food forms of that commodity by the tolerance level or the anticipated pesticide residue level. The Theoretical Maximum Residue Contribution (TMRC) is an estimate of the level of residues consumed daily if each food item contained pesticide residues equal to the tolerance. The TMRC is a ``worst case'' estimate since it is based on the assumptions that food contains pesticide residues at the tolerance level and that 100 percent of the crop is treated by pesticides that have established tolerances. If the TMRC exceeds the RfD or poses a lifetime cancer risk that is greater than approximately one in a million, EPA attempts to derive a more accurate exposure estimate for the pesticide by evaluating additional types of information (anticipated residue data and/or percent of crop treated data) which show, generally, that pesticide residues in most foods when they are eaten are well below established tolerances.

>IV. Aggregate Risk Assessment and Determination of Safety 

>Consistent with section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. Carboxin is not registered for residential use. Uniroyal Chemical Company has submitted a petition tolerance for the use of carboxin on onion (dry bulb) to the Agency; however, it is pending review. Based on the information submitted to the Agency, EPA has sufficient data to assess the hazards of carboxin and to make a determination on aggregate exposure, consistent with section 408(b)(2), for the time-limited tolerances for residues of carboxin on onion seed at 0.2 ppm. EPA's assessment of the dietary exposures and risks associated with establishing these tolerances follows. 

>A. Toxicological Profile

>1. Chronic toxicity. Based on the available chronic toxicity data, the Office of Pesticide Programs (OPP) has established the RfD for carboxin at 0.1 milligrams(mg)/ kilogram(kg)/day. The RfD for carboxin is based on a 2-year feeding study in rats with a NOEL of 10 mg/kg/day and an uncertainty factor of 100. Decreased body weight gain, increased mortality and decreased organ weight (heart, kidney, and spleen) was the effect observed at the Lowest Effect Level (LEL) of 15 mg/kg/day. 
>2. Acute toxicity. Based on available acute toxicity data, OPP has determined that the NOEL of 75 mg/kg/day from the developmental toxicity study in rabbits should be used to assess risk from acute toxicity. The maternal/developmental effects observed at the LEL of 375 mg/kg/day were abortions. The relationship between abortions produced by direct maternal toxicity (i.e. stress) and those effects mediated by reproductive/developmental mechanisms can not be clearly differentiated at this time. The population subgroup of concern for this risk assessment is females 13 years of age and older. This subgroup is representative for both maternal and fetal effects. 
>3. Carcinogenicity. Carboxin's carcinogenicity has not been classified by the Reference Dose (RfD) Committee. However, when last reviewed in 1986, there was no evidence of carcinogenicity in rats or mice.

>B. Aggregate Exposure

>Tolerances for residues of carboxin in or on food/feed commodities are currently expressed in terms of the combined residues (free and bound) of the fungicide carboxin (5,6-dihydro-2-methyl-1,4-oxathiin-3- carboxanilide) and its sulfoxide metabolite (5,6-dihydro-3- carboxanilide-2-methyl-1,4-oxathiin-4-oxide), expressed in or on certain raw agricultural commodities ranging from 0.01 ppm in eggs to 0.5 ppm in beans, hay, barley and wheat (see 40 CFR 180.301). For the purpose of assessing chronic dietary exposure from carboxin, EPA assumed tolerance level residues and 100 percent of crop treated refinements to estimate the TMRC from all established food uses for carboxin as well as the proposed use on onion seed. There are no livestock feed items associated with this section 18 request, so no additional livestock dietary burden will result from this section 18 registration. Therefore, existing meat/milk/poultry tolerances are adequate.
>Other potential sources of exposure of the general population to residues of pesticides are residues in drinking water and exposure from non-occupational (non-dietary) sources. Based on the available studies used in EPA's assessment of environmental risk, carboxin is persistent and leaches into groundwater. There are no established Maximum Concentration Levels (MCLs) for residues of carboxin in drinking water. Health Advisory (HA) Levels for carboxin in drinking water for adults are 4 and 0.7 mg/L (longer term and life time HA levels respectively) and 1 day, 10 day, and longer term HA levels are all 1 mg/L for children.
>The Agency does not have available data to perform a quantitative drinking water risk assessment for carboxin at this time. However, previous experience with persistent and mobile pesticides for which there have been available data to perform quantitative risk assessments have demonstrated that drinking water exposure is typically a small percentage of the total exposure when compared to the total dietary exposure. This observation holds even for pesticides detected in wells and drinking water at levels nearing or exceeding established MCLs. Based on this experience and OPP's best scientific judgement, and considering the low percent of the RfD occupied by dietary exposure estimates including onion seed (1.0 percent RfD for U.S. population), EPA does not anticipate that combined exposure from drinking water and dietary exposure would result in a TMRC that exceeds 100 percent of the RfD. Therefore, the EPA concludes that potential carboxin residues in drinking water are not likely to pose a human health concern. 
>Carboxin is not registered for residential use. Non-occupational exposure to the general population is therefore not expected and not considered in aggregate exposure estimates. 
>At this time, the Agency has not made a determination that carboxin and other substances that may have a common mode of toxicity would have cumulative effects. Given the time limited nature of this request, the need to make emergency exemption decisions quickly, and the significant scientific uncertainty at this time about how to define common mode of toxicity, the Agency will make its safety determination for this tolerance based on those factors which it can reasonably integrate into a risk assessment. For purposes of this tolerance only, the Agency is considering only the potential risks of carboxin in its aggregate exposure.

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>C. Safety Determinations For U.S. Population 

>EPA has concluded that dietary exposure to carboxin will utilize 1.0 percent of the RfD for the U.S. population. As mentioned before, EPA does not expect that chronic exposure from drinking water would result in an aggregate exposure which would exceed 100 percent of the RfD. EPA concludes that there is a reasonable certainty that no harm will result from aggregate exposure to carboxin residues. For the population subgroup of concern, females 13+ and older (accounts for both maternal and fetal exposure), the calculated Margin of Exposure (MOE) value is 25,000. MOE values over 100 do not exceed the Agency's level of concern for acute dietary exposure. EPA concludes that there is a reasonable certainty that no harm will result from aggregate exposure to carboxin residues.

>D. Determination of Safety for Infants and Children 

>In assessing the potential for additional sensitivity of infants and children to residues of carboxin, EPA considered pre- and post- natal toxicity studies in rat and rabbit and a 2-generation reproduction study in the rat. The developmental toxicity study in rats does not meet current guideline requirements due to the lack of maternal or developmental effects. In the maternal/developmental toxicity study in the rat the NOEL was >40 mg/kg/day highest dose tested and the NOEL in rabbits was 75 mg/kg/day with a LEL of 375 mg/ kg/day based on abortions. In addition, the acute dietary MOE for pregnant women 13+ years old is 25,000. This large MOE supports the conclusion that there are no developmental (prenatal) concerns for both females 13+ years and the pre-natal development of infants from aggregate residues of carboxin.
>In the 2-generation reproductive toxicity study in the rat, the reproductive/developmental toxicity NOEL of 10 mg/kg/day was greater than the parental (systemic) toxicity NOEL of 1 mg/kg/day which demonstrates that pup toxicity occurred in the presence of maternal toxicity. This finding suggests that post-natal development in pups is not more sensitive and that infants and children may not be more sensitive to carboxin than adult animals. This information, together with the uncertainty factor of 100 utilized to calculate the RfD for carboxin, is considered adequate protection for infants and children with respect to prenatal and postnatal development against dietary exposure to carboxin residues.
>EPA has concluded that the percent of the RfD that will be utilized by chronic dietary exposure to residues of carboxin ranges from 0.7 percent for females 13+ to 2.4 percent for non-nursing infants (<1 year old). The calculated acute MOE for the population subgroup of concern, females 13+ and older, value is 25,000. Both chronic and acute dietary exposure risk assessments assume 100 percent crop treated and use tolerance level residues for all commodities (TMRC estimates). Refinement of the dietary risk assessment by using percent crop treated and anticipated residue (ARC) data would reduce dietary exposure. Therefore, both of these risk assessments are also an over-estimate of dietary risk. Consideration of ARC and percent crop treated would likely result in an ARC which would occupy a percent of the RfD that is likely to be significantly lower than the currently calculated TMRC value. Additionally, the acute dietary MOE would be greater than the current MOE. The addition of potential exposure from carboxin residues in drinking water is not expected to result in an exposure which would exceed the RfD. EPA therefore concludes that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to carboxin residues. 
>FFDCA section 408 provides that EPA shall apply an additional safety factor for infants and children in the case of threshold effects to account for pre- and post-natal toxicity and the completeness of the data base unless EPA concludes, based on reliable data, that said additional safety factor is unnecessary. Should an additional uncertainty factor be deemed appropriate, when considered in conjunction with a refine exposure estimate, it is unlikely that the dietary risk will exceed 100 percent of the RfD. Therefore, EPA concludes that this tolerance will not pose an unacceptable risk to infants and children.

>V. Other Considerations

>The metabolism of carboxin in plants and animals is adequately understood for the purposes of this tolerance. There are no Codex maximum residue levels established for residues of carboxin on onion seed. Adequate methods for purposes of data collection and enforcement of tolerance for carboxin residues are available. Methods for enforcement of tolerances in/on various plant and animal commodities are listed in the Pesticide Analytical Manual (PAM) Vol. II as Method I and Method II.

>VI. Conclusion

>Therefore, a tolerance in connection with the FIFRA section 18 emergency exemptions is established for residues of carboxin on onion seed at 0.2 ppm. This tolerance will expire and be automatically revoked without further action by EPA on January 17, 1998. 

>VII. Objections and Hearing Requests

>The new FFDCA section 408(g) provides essentially the same process for persons to ``object'' to a tolerance regulation issued by EPA under new section 408(e) and (l)(6) as was provided in the old section 408 and in section 409. However, the period for filing objections is 60 days, rather than 30 days. EPA currently has procedural regulations which govern the submission of objections and hearing requests. These regulations will require some modification to reflect the new law. However, until those modifications can be made, EPA will continue to use those procedural regulations with appropriate adjustments to reflect the new law.
>Any person may, by April 4, 1997, file written objections to any aspect of this regulation (including the automatic revocation provision) and may also request a hearing on those objections. Objections and hearing requests must be filed with the Hearing Clerk, at the address given above (40 CFR 178.20). A copy of the objections and/or hearing requests filed with the Hearing Clerk should be submitted to the OPP docket for this rulemaking. The objections submitted must specify the provisions of the regulation deemed objectionable and the grounds for the objections (40 CFR 178.25). Each objection must be accompanied by the fee prescribed by 40 CFR 180.33(i). If a hearing is requested, the objections must include a statement of the factual issues on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the requestor (40 CFR 178.27). A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established, resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32). 
>Information submitted in connection with an objection or hearing request

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>may be claimed confidential by marking any part or all of that information as Confidential Business Information (CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice.

>VIII. Public Docket

>EPA has established a record for this rulemaking under docket number [OPP-300450] (including any comments and data submitted electronically). A public version of this record, including printed, paper versions of electronic comments, which does not include any information claimed as CBI, is available for inspection from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The public record is located in Room 1132 of the Public Response and Program Resources Branch, Field Operations Division (7506C), Office of Pesticide Programs, Environmental Protection Agency, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA. 
>Electronic comments may be sent directly to EPA at: opp-docket@epamail.epa.gov.

>Electronic comments must be submitted as an ASCII file avoiding the use of special characters and any form of encryption. 
>The official record for this rulemaking, as well as the public version, as described above, is kept in paper form. Accordingly, in the event there are objections and hearing requests, EPA will transfer any copies of objections and hearing requests received electronically into printed, paper form as they are received and will place the paper copies in the official rulemaking record. The official rulemaking record is the paper record maintained at the address in ``ADDRESSES'' at the beginning of this document.

>IX. Regulatory Assessment Requirements

>Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a ``significant regulatory action'' and, since this action does not impose any information collection requirements as defined by the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., it is not subject to review by the Office of Management and Budget. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), or require prior consultation with State officials as specified by Executive Order 12875 (58 FR 58093, October 28, 1993), or special considerations as required by Executive Order 12898 (59 FR 7629, February 16, 1994).
>Because FFDCA section 408(l)(6) permits establishment of this regulation without a notice of proposed rulemaking, the regulatory flexibility analysis requirements of the Regulatory Flexibility Act, 5 U.S.C. 604(a), do not apply.
>Under 5 U.S.C. 801(a)(1)(A) of the Administrative Procedure Act (APA) as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (Title II of Pub. L. 104-121, 110 Stat. 847), EPA submitted a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives and the Comptroller General of the General Accounting Office prior to publication of the rule in today's Federal Register. This rule is not a ``major rule'' as defined by 5 U.S.C. 804(2) of the APA as amended. 

>List of Subjects in 40 CFR Part 180

>Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.

>Dated: January 21, 1997.

>Daniel M. Barolo,

>Director, Office of Pesticide Programs. 

>Therefore, 40 CFR Chapter I is amended as follows: 

>PART 180--[AMENDED]

>1. The authority citation for part 180 continues to read as follows:
>Authority: 21 U.S.C. 346a and 371.

>2. In Sec. 180.301, by designated the existing text as paragraph (a) and by adding a new paragraph (b) to read as follows: 


>Sec. 180.301 Carboxin; tolerances for residues. 

>* * * * *
>(b) A time-limited tolerance is established for residues of the combined residues (free and bound) of the fungicide carboxin [5,6- dihydro-2-methyl-1,4-oxathiin-3-carboxanilide) and its sulfoxide metabolite (5,6-dihydro-3-carboxanilide-2-methyl-1,4-oxathiin-4-oxide), each expressed as the parent compound in connection with use of the pesticide under section 18 emergency exemptions granted by EPA. The tolerance is specified in the following table. The tolerance expires and is automatically revoked on the date specified in the table without further action by EPA.

>----------------------------------------------------------------------------->Commodity                   Parts per
>                             million            Expiration/Revocation Date
>----------------------------------------------------------------------------->Onion Seed.................... 0.2                 January 17, 1998
>-----------------------------------------------------------------------------