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					                                        2812                  Federal Register / Vol. 73, No. 11 / Wednesday, January 16, 2008 / Rules and Regulations

                                                                                                                    Commodity                                                                                        Parts per million

                                                                                                 *               *               *               *              *
                                        Berry, low growing subgroups 13–07G ...............................................................................................................................                              0.60
                                        Bushberry subgroup 13–07B ...............................................................................................................................................                         1.6
                                        Caneberry subgroup 13–07A ..............................................................................................................................................                          1.6
                                                                                                 *               *               *               *              *
                                        Onion, bulb, subgroup 3–07A ..............................................................................................................................................                       0.02
                                        Onion, green, subgroup 3–07B ...........................................................................................................................................                          4.5
                                                                                                 *               *               *               *              *



                                        *        *        *        *        *        
                        index, some information is not publicly                                   This listing is not intended to be
                                        [FR Doc. E8–683 Filed 1–15–08; 8:45 am] 
                             available, e.g., Confidential Business                                 exhaustive, but rather to provide a guide
                                        BILLING CODE 6560–50–S                                                Information (CBI) or other information                                 for readers regarding entities likely to be
                                                                                                              whose disclosure is restricted by statute.                             affected by this action. Other types of
                                                                                                              Certain other material, such as                                        entities not listed in this unit could also
                                        ENVIRONMENTAL PROTECTION                                              copyrighted material, is not placed on                                 be affected. The North American
                                        AGENCY                                                                the Internet and will be publicly                                      Industrial Classification System
                                                                                                              available only in hard copy form.                                      (NAICS) codes have been provided to
                                        40 CFR Part 180                                                       Publicly available docket materials are                                assist you and others in determining
                                        [EPA–HQ–OPP–2007–0461; FRL–8346–6]                                    available in the electronic docket at                                  whether this action might apply to
                                                                                                              http://www.regulations.gov, or, if only                                certain entities. If you have any
                                        Mandipropamid; Pesticide Tolerance                                    available in hard copy, at the OPP                                     questions regarding the applicability of
                                                                                                              Regulatory Public Docket in Rm. S–                                     this action to a particular entity, consult
                                        AGENCY:  Environmental Protection                                     4400, One Potomac Yard (South Bldg.),                                  the person listed under FOR FURTHER
                                        Agency (EPA).                                                         2777 S. Crystal Dr., Arlington, VA. The                                INFORMATION CONTACT.
                                        ACTION: Final rule.                                                   Docket Facility is open from 8:30 a.m.
                                                                                                                                                                                     B. How Can I Access Electronic Copies
                                        SUMMARY:    This regulation establishes a                             to 4 p.m., Monday through Friday,
                                                                                                                                                                                     of this Document?
                                        tolerance for residues of                                             excluding legal holidays. The Docket
                                                                                                              Facility telephone number is (703) 305–                                  In addition to accessing an electronic
                                        mandipropamid, 4-chloro-N-[2-[3-
                                                                                                              5805.                                                                  copy of this Federal Register document
                                        methoxy-4-(2-
                                                                                                              FOR FURTHER INFORMATION CONTACT: Rose
                                                                                                                                                                                     through the electronic docket at http://
                                        propynyloxy)phenyl]ethyl]-alpha-(2-
                                                                                                              Mary Kearns, Registration Division                                     www.regulations.gov, you may access
                                        propynyloxy)-benzeneacetamide in or
                                                                                                              (7505P), Office of Pesticide Programs,                                 this Federal Register document
                                        on Brassica, head and stem, subgroup
                                                                                                              Environmental Protection Agency, 1200                                  electronically through the EPA Internet
                                        5A; Brassica, leafy greens, subgroup 5B;
                                                                                                              Pennsylvania Ave., NW., Washington,                                    under the ‘‘Federal Register’’ listings at
                                        vegetable, cucurbit, group 9; vegetable,
                                                                                                              DC 20460–0001; telephone number:                                       http://www.epa.gov/fedrgstr. You may
                                        fruiting, group 8; okra; vegetable, leafy
                                                                                                              (703) 305-5611; e-mail address:                                        also access a frequently updated
                                        except brassica, group 4; vegetable,
                                                                                                              kearns.rosemary@epa.gov.                                               electronic version of EPA’s tolerance
                                        tuberous and corm, subgroup 1C; grape;
                                                                                                                                                                                     regulations at 40 CFR part 180 through
                                        grape, raisin; onion, dry bulb; onion,                                SUPPLEMENTARY INFORMATION:                                             the Government Printing Office’s pilot
                                        green; and potato, wet peel. Syngenta
                                                                                                              I. General Information                                                 e-CFR site at http://www.gpoaccess.gov/
                                        Crop Protection Inc. requested this
                                                                                                                                                                                     ecfr.
                                        tolerance under the Federal Food, Drug,                               A. Does this Action Apply to Me?
                                        and Cosmetic Act (FFDCA).                                                                                                                    C. Can I File an Objection or Hearing
                                        DATES: This regulation is effective                                      You may be potentially affected by                                  Request?
                                        January 16, 2008. Objections and                                      this action if you are an agricultural                                   Under section 408(g) of FFDCA, any
                                        requests for hearings must be received                                producer, food manufacturer, or                                        person may file an objection to any
                                        on or before March 17, 2008, and must                                 pesticide manufacturer. Potentially                                    aspect of this regulation and may also
                                        be filed in accordance with the                                       affected entities may include, but are                                 request a hearing on those objections.
                                        instructions provided in 40 CFR part                                  not limited to those engaged in the                                    You must file your objection or request
                                        178 (see also Unit I.C. of the                                        following activities:                                                  a hearing on this regulation in
                                        SUPPLEMENTARY INFORMATION).                                              • Crop production (NAICS code 111),                                 accordance with the instructions
                                        ADDRESSES: EPA has established a                                      e.g., agricultural workers; greenhouse,                                provided in 40 CFR part 178. To ensure
                                        docket for this action under docket                                   nursery, and floriculture workers;                                     proper receipt by EPA, you must
                                        identification (ID) number EPA–HQ–                                    farmers.                                                               identify docket ID number EPA–HQ–
                                        OPP–2007–0461. To access the                                             • Animal production (NAICS code                                     OPP–2007–0461 in the subject line on
                                        electronic docket, go to http://                                      112), e.g., cattle ranchers and farmers,                               the first page of your submission. All
                                        www.regulations.gov, select ‘‘Advanced                                dairy cattle farmers, livestock farmers.                               requests must be in writing, and must be
                                        Search,’’ then ‘‘Docket Search.’’ Insert                                 • Food manufacturing (NAICS code                                    mailed or delivered to the Hearing Clerk
                                        the docket ID number where indicated                                  311), e.g., agricultural workers; farmers;                             as required by 40 CFR part 178 on or
                                        and select the ‘‘Submit’’ button. Follow                              greenhouse, nursery, and floriculture                                  before March 17, 2008.
                                        the instructions on the regulations.gov                               workers; ranchers; pesticide applicators.                                In addition to filing an objection or
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                                        website to view the docket index or                                      • Pesticide manufacturing (NAICS                                    hearing request with the Hearing Clerk
                                        access available documents. All                                       code 32532), e.g., agricultural workers;                               as described in 40 CFR part 178, please
                                        documents in the docket are listed in                                 commercial applicators; farmers;                                       submit a copy of the filing that does not
                                        the docket index available in                                         greenhouse, nursery, and floriculture                                  contain any CBI for inclusion in the
                                        regulations.gov. Although listed in the                               workers; residential users.                                            public docket that is described in


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                                                         Federal Register / Vol. 73, No. 11 / Wednesday, January 16, 2008 / Rules and Regulations                                          2813

                                        ADDRESSES.   Information not marked                     However, a separate tolerance for okra                 3 ppm; onion, dry bulb at 0.05 ppm;
                                        confidential pursuant to 40 CFR part 2                  must be listed in the 40 CFR 180.637,                  onion, green at 4 ppm; and okra at 1
                                        may be disclosed publicly by EPA                        until the new crop group regulation is                 ppm and potato, wet peel at 0.03 ppm.
                                        without prior notice. Submit this copy,                 published. A tolerance for tomato paste                EPA’s assessment of exposures and risks
                                        identified by docket ID number EPA–                     was requested. However, the maximum                    associated with establishing the
                                        HQ–OPP–2007–0461, by one of the                         expected residue in tomato paste and                   tolerance follows.
                                        following methods:                                      puree resulting from the proposed use
                                          • Federal eRulemaking Portal: http://                                                                        A. Toxicological Profile
                                                                                                will be covered by the recommended
                                        www.regulations.gov. Follow the on-line                 tolerance for vegetable, fruiting, crop                  EPA has evaluated the available
                                        instructions for submitting comments.                   group 8. A separate tolerance is being                 toxicity data and considered its validity,
                                          • Mail: Office of Pesticide Programs                  established for potato, wet peel, even                 completeness, and reliability as well as
                                        (OPP) Regulatory Public Docket (7502P),                 though it was not requested. The                       the relationship of the results of the
                                        Environmental Protection Agency, 1200                   maximum expected residue in potato,                    studies to human risk. EPA has also
                                        Pennsylvania Ave., NW., Washington,                     wet peel resulting from the proposed                   considered available information
                                        DC 20460–0001.                                          use is 0.03 ppm which was calculated                   concerning the variability of the
                                          • Delivery: OPP Regulatory Public                     by multiplying the HAFT of <0.01 ppm                   sensitivities of major identifiable
                                        Docket (7502P), Environmental                           by the observed concentration factor of                subgroups of consumers, including
                                        Protection Agency, Rm. S–4400, One                      >3x. Potatoes have a separate tolerance                infants and children. Specific
                                        Potomac Yard (South Bldg.), 2777 S.                     under the vegetable, tuberous and corm                 information on the studies received and
                                        Crystal Dr., Arlington, VA. Deliveries                  subgroup 1C.                                           the nature of the adverse effects caused
                                        are only accepted during the Docket’s                                                                          by mandipropamid as well as the no-
                                        normal hours of operation (8:30 a.m. to                 III. Aggregate Risk Assessment and                     observed-adverse-effect-level (NOAEL)
                                        4 p.m., Monday through Friday,                          Determination of Safety                                and the lowest-observed-adverse-effect-
                                        excluding legal holidays). Special                         Section 408(b)(2)(A)(i) of FFDCA                    level (LOAEL) from the toxicity studies
                                        arrangements should be made for                         allows EPA to establish a tolerance (the               can be found in the docket established
                                        deliveries of boxed information. The                    legal limit for a pesticide chemical                   by this action, which is described under
                                        Docket Facility telephone number is                     residue in or on a food) only if EPA                   ADDRESSES, and is identified as
                                        (703) 305–5805.                                         determines that the tolerance is ‘‘safe.’’             ‘‘Mandipropamid: Human Health Risk
                                                                                                Section 408(b)(2)(A)(ii) of FFDCA                      Assessment for Proposed Uses’’ in that
                                        II. Petition for Tolerance
                                                                                                defines ‘‘safe’’ to mean that ‘‘there is a             docket.
                                           In the Federal Register of July 25,                  reasonable certainty that no harm will
                                        2007 (72 FR 40877) (FRL–8137–1) and                                                                            B. Toxicological Endpoints
                                                                                                result from aggregate exposure to the
                                        October 31, 2007 (72 FR 61637) (FRL                     pesticide chemical residue, including                     For hazards that have a threshold
                                        8154-8) EPA issued notices pursuant to                  all anticipated dietary exposures and all              below which there is no appreciable
                                        section 408(d)(3) of FFDCA, 21 U.S.C.                   other exposures for which there is                     risk, the toxicological level of concern
                                        346a(d)(3), announcing the filing of                    reliable information.’’ This includes                  (LOC) is derived from the highest dose
                                        pesticide petitions (PP7F7184 and                       exposure through drinking water and in                 at which no adverse effects are observed
                                        6F7057) by Syngenta Crop Protection                     residential settings, but does not include             (the NOAEL) in the toxicology study
                                        Inc., P.O. Box 18300, Greensboro, NC                    occupational exposure. Section                         identified as appropriate for use in risk
                                        27419. The petition (6F7057) requested                  408(b)(2)(C) of FFDCA requires EPA to                  assessment. However, if a NOAEL
                                        that 40 CFR part 180 be amended by                      give special consideration to exposure                 cannot be determined, the lowest dose
                                        establishing tolerances for residues of                 of infants and children to the pesticide               at which adverse effects of concern are
                                        the fungicide mandipropamid, 4-chloro-                  chemical residue in establishing a                     identified (the LOAEL) is sometimes
                                        N-[2-[3-methoxy-4-(2-                                   tolerance and to ‘‘ensure that there is a              used for risk assessment. Uncertainty/
                                        propynyloxy)phenyl]ethyl]-alpha-(2-                     reasonable certainty that no harm will                 safety factors (UFs) are used in
                                        propynyloxy)-benzeneacetamide, in or                    result to infants and children from                    conjunction with the LOC to take into
                                        on Brassica, head and stem, Subgroup                    aggregate exposure to the pesticide                    account uncertainties inherent in the
                                        5A at 3 parts per million (ppm);                        chemical residue....’’ These provisions                extrapolation from laboratory animal
                                        Brassica, leafy greens, subgroup 5B at 30               were added to FFDCA by the Food                        data to humans and in the variations in
                                        ppm; vegetable, cucurbit, group 9 at .3                 Quality Protection Act (FQPA) of 1996.                 sensitivity among members of the
                                        ppm; vegetable, fruiting, group 8 at 1                     Consistent with FFDCA section                       human population as well as other
                                        ppm; vegetable, leafy except Brassica,                  408(b)(2)(D), and the factors specified in             unknowns. Safety is assessed for acute
                                        group 4 at 20 ppm; vegetable, tuberous                  FFDCA section 408(b)(2)(D), EPA has                    and chronic risks by comparing
                                        and corm, subgroup 1C at 0.01 ppm;                      reviewed the available scientific data                 aggregate exposure to the pesticide to
                                        grape at 2 ppm; grape, raisin at 4 ppm;                 and other relevant information in                      the acute population adjusted dose
                                        onion, dry bulb at 0.05 ppm; onion,                     support of this action. EPA has                        (aPAD) and chronic population adjusted
                                        green at 4 ppm; and tomato paste at 1.3                 sufficient data to assess the hazards of               dose (cPAD). The aPAD and cPAD are
                                        ppm. That notice referenced a summary                   and to make a determination on                         calculated by dividing the LOC by all
                                        of the petition prepared by Syngenta                    aggregate exposure for the petitioned-for              applicable UFs. Short-, intermediate-,
                                        Crop Protection, Inc., the registrant,                  tolerance for residues of                              and long-term risks are evaluated by
                                        which is available to the public in the                 mandipropamid on Brassica, head and                    comparing aggregate exposure to the
                                        docket, http://www.regulations.gov.                     stem, subgroup 5A at 3 ppm; Brassica,                  LOC to ensure that the margin of
                                        Comments were received on the notice                    leafy greens, subgroup 5B at 25 ppm;                   exposure (MOE) called for by the
                                        of filing. EPA’s response to these                      vegetable, cucurbit, group 9 at 0.6 ppm;               product of all applicable UFs is not
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                                        comments is discussed in Unit IV.B..                    vegetable, fruiting, group 8 at 1 ppm;                 exceeded.
                                           Based upon review of the data                        okra at 1.0 ppm; vegetable, leafy except                  For non-threshold risks, the Agency
                                        supporting the petition, EPA has                        Brassica, group 4 at 20 ppm; vegetable,                assumes that any amount of exposure
                                        recommended the inclusion of okra in                    tuberous and corm, subgroup 1C at 0.01                 will lead to some degree of risk and
                                        Crop Group 8 (Vegetable, Fruiting).                     ppm; grape at 1.4 ppm; grape, raisin at                estimates risk in terms of the probability


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                                        2814             Federal Register / Vol. 73, No. 11 / Wednesday, January 16, 2008 / Rules and Regulations

                                        of occurrence of additional adverse                     complete description of the risk                          A summary of the toxicological
                                        cases. Generally, cancer risks are                      assessment process, see http://                         endpoints for mandipropamid used for
                                        considered non-threshold. For more                      www.epa.gov/pesticides/factsheets/                      human risk assessment is shown in
                                        information on the general principles                   riskassess.htm.                                         Table 1 of this unit.
                                        EPA uses in risk characterization and a

                                         TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR MANDIPROPAMID FOR USE IN DIETARY HUMAN RISK

                                                                                     ASSESSMENT

                                                                                                                                         RfD, PAD, Level of
                                                                                                             Uncertainty/FQPA
                                                   Exposure/Scenario                Point of Departure                                    Concern for Risk          Study and Toxicological Effects
                                                                                                              Safety Factors                Assessment

                                          Acute Dietary (General Popu­             N/A                      N/A                          N/A                    No appropriate endpoint was identified.
                                            lation, including Infants and
                                            Children)

                                          Acute    Dietary(Females        13-49    N/A                      N/A                          N/A                    No appropriate endpoint was identified.
                                            years of age)

                                          Chronic Dietary (All Populations)        NOAEL = 5 mg/kg/         UFA = 10X .............      Chronic RfD = 0.05     Chronic toxicity – dogs
                                                                                    day                     UFH = 10X                      mg/kg/day            LOAEL = 40 mg/kg/day, based on evi­
                                                                                                            FQPA SF = 1X                 cPAD = 0.05 mg/          dence of liver toxicity (increased inci­
                                                                                                                                           kg/day                 dence and severity of microscopic
                                                                                                                                                                  pigment in the liver and increased
                                                                                                                                                                  alkaline phosphatase activity in both
                                                                                                                                                                  sexes as well as increased alanine
                                                                                                                                                                  aminotransferase activity in males).

                                          Cancer                                                                  ‘‘Not Likely to be Carcinogenic to Humans.’’
                                                                                     No treatment-related tumors observed in carcinogenicity studies in rats and mice. A cancer risk assess­
                                                                                                                               ment is not needed.
                                          NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UFA = extrapolation from
                                        animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies). FQPA SF =
                                        FQPA Safety Factor. PAD = population adjusted dose (c = chronic). RfD = reference dose. N/A = not applicable.


                                        C. Exposure Assessment                                  Fate and Effects Division directly into                 GROW) models, the estimated
                                           1. Dietary exposure from food and                    the analysis. The chronic dietary                       environmental concentrations (EECs) of
                                        feed uses. In evaluating dietary                        exposure analysis for mandipropamid                     mandipropamid for acute exposures are
                                        exposure to mandipropamid, EPA                          results in dietary risk estimates for food              estimated to be 25.2 parts per billion
                                        considered exposure under the                           and water that are below the Agency’s                   (ppb) for surface water and 0.05 ppb for
                                        petitioned-for tolerances. EPA assessed                 level of concern for chronic dietary                    ground water. The EECs for the aquatic
                                        dietary exposures from mandipropamid                    exposure.                                               degradates SYN500003 and SYN504851
                                        in food as follows:                                        iii. Cancer. There were no treatment-                are estimated to be 2.32 and 8.99 ppb for
                                           i. Acute exposure. Quantitative acute                related tumors observed in                              surface water and 0.6 and 1.7 ppb for
                                        dietary exposure and risk assessments                   carcinogenicity studies in rats and mice.               ground water. The combined level of
                                        are performed for a food-use pesticide,                 Mandipropamid is classified as not                      mandipropamid and the degradates in
                                        if a toxicological study has indicated the              likely to be a human carcinogen.                        surface water is 36.5 ppb.
                                        possibility of an effect of concern                     Therefore, a cancer dietary exposure                       Modeled estimates of drinking water
                                        occurring as a result of a 1–day or single              assessment was not performed.                           concentrations were directly entered
                                        exposure.                                                  2. Dietary exposure from drinking                    into the dietary exposure model. For
                                           No such effects were identified in the               water. The Agency lacks sufficient                      chronic dietary risk assessment, the
                                        toxicological studies for                               monitoring data to complete a                           acute water concentration of value 36.5
                                        mandipropamid; therefore, a                             comprehensive dietary exposure                          ppb was used to conservatively assess
                                        quantitative acute dietary exposure                     analysis and risk assessment for                        the contribution to drinking water.
                                        assessment is unnecessary.                              mandipropamid in drinking water.                           3. From non-dietary exposure. The
                                           ii. Chronic exposure. In conducting                  Because the Agency does not have                        term ‘‘residential exposure’’ is used in
                                        the chronic dietary exposure assessment                 comprehensive monitoring data,                          this document to refer to non-
                                        EPA used the food consumption data                      drinking water concentration estimates                  occupational, non-dietary exposure
                                        from the USDA 1994–1996, or 1998;                       are made by reliance on simulation or                   (e.g., for lawn and garden pest control,
                                        CSFII. As to residue levels in food, EPA                modeling taking into account data on                    indoor pest control, termiticides, and
                                        relied upon tolerance level residues and                the environmental fate characteristics of               flea and tick control on pets).
                                        percent crop treated (PCT) information                  mandipropamid. Further information                         Mandipropamid is not registered for
                                        for all commodities A unrefined chronic                 regarding EPA drinking water models                     use on any sites that would result in
                                        exposure assessment that assumes 100%                   used in pesticide exposure assessment                   residential exposure.
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                                        crop treated was conducted for the                      can be found at http://www.epa.gov/                        4. Cumulative effects from substances
                                        proposed Section 3 uses of                              oppefed1/models/water/index.htm.                        with a common mechanism of toxicity.
                                        mandipropamid. The DEEM analysis                           Based on the First Index Reservoir                   Section 408(b)(2)(D)(v) of FFDCA
                                        incorporates estimates of drinking water                Screening Tool (FIRST), and Screening                   requires that, when considering whether
                                        concentrations from the Environmental                   Concentration in Ground Water (SCI-                     to establish, modify, or revoke a


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                                                         Federal Register / Vol. 73, No. 11 / Wednesday, January 16, 2008 / Rules and Regulations                                          2815

                                        tolerance, the Agency consider                          susceptibility in fetuses and pups with                   5. Determination of safety. Based on
                                        ‘‘available information’’ concerning the                in utero and post-natal exposure.                      these risk assessments, EPA concludes
                                        cumulative effects of a particular                        iii. The toxicity data indicates that                that there is a reasonable certainty that
                                        pesticide’s residues and ‘‘other                        there are no neurotoxic effects.                       no harm will result to the general
                                        substances that have a common                             iv. The dietary food exposure                        population, or to infants and children
                                        mechanism of toxicity.’’                                assessment is based on tolerance-level                 from aggregate exposure to
                                           Unlike other pesticides for which EPA                residues and assumes 100% crop treated                 mandipropamid residues.
                                        has followed a cumulative risk approach                 for all commodities, which results in
                                        based on a common mechanism of                          very high-end estimates of dietary                     IV. Other Considerations
                                        toxicity, EPA has not made a common                     exposure.                                              A. Analytical Enforcement Methodology
                                        mechanism of toxicity finding as to                       v. The dietary drinking water
                                                                                                                                                         Adequate enforcement methodology
                                        mandipropamid and any other                             assessment is based on values generated                Analytical Method RAM 415/01 Residue
                                        substances and mandipropamid does                       by model and associated modeling                       Analytical Method for the
                                        not appear to produce a toxic metabolite                parameters which are designed to                       Determination of Mandipropamid in
                                        produced by other substances. For the                   provide conservative, health protective,               Crop Samples. Final Determination by
                                        purposes of this tolerance action,                      high-end estimates of water                            LC/MS/MS and the Analytical Method
                                        therefore, EPA has not assumed that                     concentrations.                                        Development and Validation (German S-
                                        mandipropamid has a common                                vi. No residential uses are proposed at
                                                                                                                                                       19) for the determination of residues of
                                        mechanism of toxicity with other                        this time.
                                                                                                                                                       MA Mandipropamid in or on Plant
                                        substances. For information regarding                   E. Aggregate Risks and Determination of                Matrices is available to enforce the
                                        EPA’s efforts to determine which                        Safety                                                 tolerance expression. The method may
                                        chemicals have a common mechanism                                                                              be requested from: Chief, Analytical
                                        of toxicity and to evaluate the                            Safety is assessed for acute and
                                                                                                chronic risks by comparing aggregate                   Chemistry Branch, Environmental
                                        cumulative effects of such chemicals,                                                                          Science Center, 701 Mapes Rd., Ft.
                                        see EPA’s website at http://                            exposure to the pesticide to the aPAD
                                                                                                and cPAD. The aPAD and cPAD are                        Meade, MD 20755–5350; telephone
                                        www.epa.gov/pesticides/cumulative.                                                                             number: (410) 305–2905; e-mail address:
                                                                                                calculated by dividing the LOC by all
                                        D. Safety Factor for Infants and                        applicable UFs. For linear cancer risks,               residuemethods@epa.gov.
                                        Children                                                EPA calculates the probability of                      B. International Residue Limits
                                           1. In general. Section 408 of FFDCA                  additional cancer cases given aggregate                  There are no specific CODEX,
                                        provides that EPA shall apply an                        exposure. Short-, intermediate-, and                   Canadian or Mexican maximum residue
                                        additional (‘‘10X’’) tenfold margin of                  long-term risks are evaluated by                       limits (MRLs) for mandipropamid.
                                        safety for infants and children in the                  comparing aggregate exposure to the
                                        case of threshold effects to account for                LOC to ensure that the MOE called for                  C. General Response to Comments
                                        prenatal and postnatal toxicity and the                 by the product of all applicable UFs is                   Several comments were received from
                                        completeness of the database on toxicity                not exceeded.                                          a private citizen objecting to
                                        and exposure unless EPA determines                         1. Acute risk. No acute dietary                     establishment of tolerances. The agency
                                        based on reliable data that a different                 endpoint based on effects attributable to              has received similar comments from this
                                        margin of safety will be safe for infants               a single dose could be identified based                commenter on numerous previous
                                        and children. This additional margin of                 on the toxicology data currently                       occasions. Refer to Federal Register 70
                                        safety is commonly referred to as the                   available for mandipropamid. Therefore,                FR 37686 (June 30, 2005), 70 FR 1354
                                        FQPA safety factor. In applying this                    mandipropamid is not expected to pose                  (January 7, 2005), 69 FR 63096-63098
                                        provision, EPA either retains the default               an acute risk.                                         (October 29, 2004) for the Agency’s
                                        value of 10X when reliable data do not                     2. Chronic risk. There are no                       response to these objections. In
                                        support the choice of a different factor,               residential uses proposed or registered                addition, the commenter noted several
                                        or, if reliable data are available, EPA                 for mandipropamid, and therefore                       adverse effects seen in animal
                                        uses a different additional FQPA safety                 aggregate risk is equal to that from                   toxicology studies with mandipropamid
                                        factor value based on the use of                        consumption of food and water. Chronic                 and claims because of these effects no
                                        traditional UFs and/or special FQPA                     aggregate risk estimates associated with               tolerance should be approved. EPA has
                                        safety factors, as appropriate.                         exposure to mandipropamid residues in                  found, however, that there is reasonable
                                           2. Prenatal and postnatal sensitivity.               food and water do not exceed the                       certainty of no harm to humans after
                                        There is no evidence (quantitative or                   Agency’s level of concern. For                         considering these toxicological studies
                                        qualitative) of increased susceptibility                mandipropamid, the chronic dietary                     and the exposure levels of humans to
                                        and no residual uncertainties with                      exposure estimate was 22% of the cPAD                  mandipropamid.
                                        regard to prenatal toxicity following in                for the U.S. population and was 30% of
                                                                                                the cPAD for the highest exposed                       V. Conclusion
                                        utero exposure to rats or rabbits
                                        (developmental studies) and pre and/or                  population subgroup, children 1-2 years                  Therefore, the tolerances are
                                        post-natal exposures to rats                            of age.                                                established for residues of
                                        (reproduction study).                                      3. Short-term and intermediate-term                 mandipropamid, 4-chloro-N-[2-[3-
                                           3. Conclusion. EPA has determined                    risk. Short and intermediate-term                      methoxy-4-(2-
                                        that reliable data show that it would be                dermal exposures and risks were not                    propynyloxy)phenyl]ethyl]-alpha-(2-
                                        safe for infants and children to reduce                 assessed for mandipropamid, since                      propynyloxy)-benzeneacetamide, in or
                                        the FQPA safety factor to 1X. That                      mandipropamid is not registered for use                on Brassica, head and stem, subgroup
                                        decision is based on the following                      on any sites that would result in                      5A at 3 ppm; Brassica, leafy greens,
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                                        findings:                                               residential exposure.                                  subgroup 5B at 25 ppm; vegetable,
                                           i. The toxicological database for                       4. Aggregate cancer risk for U.S.                   cucurbit, group 9 at 0.6 ppm; vegetable,
                                        mandipropamid is complete.                              population. Aggregate cancer risk was                  fruiting, group 8 at 1.0 ppm; okra at 1.0
                                           ii. The toxicity data showed no                      not assessed because mandipropamid is                  ppm; vegetable, leafy, except Brassica,
                                        increase in qualitative or quantitative                 not likely to be carcinogenic in humans.               group 4 at 20 ppm; vegetable, tuberous


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                                        2816             Federal Register / Vol. 73, No. 11 / Wednesday, January 16, 2008 / Rules and Regulations

                                        and corm, subgroup 1C at 0.01 ppm;                      1999) and Executive Order 13175,                                 Commodity                      Parts per million
                                        grape at 1.4 ppm; grape, raisin at 3.0                  entitled Consultation and Coordination
                                        ppm; onion, dry bulb at 0.05 ppm;                       with Indian Tribal Governments (65 FR                  Brassica, head and stem,
                                        onion, green at 4 ppm; and potato, wet                  67249, November 6, 2000) do not apply                    subgroup 5A ................                               3
                                        peel at 0.03 ppm. A tolerance for tomato                to this rule. In addition, This rule does              Brassica, leafy greens,
                                        paste is not being established because                  not impose any enforceable duty or                       subgroup 5B ................                          25
                                                                                                                                                       Vegetable, cucurbit,
                                        residue expected will be covered by the                 contain any unfunded mandate as                          group 9 ........................                      0.6
                                        vegetable, fruiting crop group 8.                       described under Title II of the Unfunded               Vegetable, fruiting, group
                                        VI. Statutory and Executive Order                       Mandates Reform Act of 1995 (UMRA)                       8 ..................................                  1.0
                                        Reviews                                                 (Public Law 104–4).                                    Vegetable, leafy except
                                                                                                  This action does not involve any                       Brassica, group 4 ........                            20
                                           This final rule establishes a tolerance                                                                     Vegetable, tuberous and
                                        under section 408(d) of FFDCA in                        technical standards that would require
                                                                                                                                                         corm, subgroup 1C .....                             0.01
                                        response to a petition submitted to the                 Agency consideration of voluntary                      Grape ..............................                   1.4
                                        Agency. The Office of Management and                    consensus standards pursuant to section                Grape, raisin ...................                      3.0
                                        Budget (OMB) has exempted these types                   12(d) of the National Technology                       Okra ................................                  1.0
                                        of actions from review under Executive                  Transfer and Advancement Act of 1995                   Onion, dry bulb ...............                       0.05
                                        Order 12866, entitled Regulatory                        (NTTAA), Public Law 104–113, section                   Onion, green ...................                         4
                                        Planning and Review (58 FR 51735,                       12(d) (15 U.S.C. 272 note).                            Potato, wet peel ..............                       0.03
                                        October 4, 1993). Because this rule has                 VII. Congressional Review Act                            (b) Section 18 emergency exemptions.
                                        been exempted from review under
                                                                                                   The Congressional Review Act, 5                     [Reserved]
                                        Executive Order 12866, this rule is not
                                                                                                U.S.C. 801 et seq., generally provides                   (c) Tolerances with regional
                                        subject to Executive Order 13211,
                                                                                                that before a rule may take effect, the                registrations. [Reserved]
                                        Actions Concerning Regulations That
                                                                                                agency promulgating the rule must                        (d) Indirect or inadvertent tolerances.
                                        Significantly Affect Energy Supply,
                                        Distribution, or Use (66 FR 28355, May                  submit a rule report to each House of                  [Reserved] 

                                        22, 2001) or Executive Order 13045,                     the Congress and to the Comptroller                    [FR Doc. E8–677 Filed 1–15–08; 8:45 am] 

                                        entitled Protection of Children from                    General of the United States. EPA will                 BILLING CODE 6560–50–S

                                        Environmental Health Risks and Safety                   submit a report containing this rule and
                                        Risks (62 FR 19885, April 23, 1997).                    other required information to the U.S.
                                        This final rule does not contain any                    Senate, the U.S. House of                              DEPARTMENT OF HOMELAND
                                        information collections subject to OMB                  Representatives, and the Comptroller                   SECURITY
                                        approval under the Paperwork                            General of the United States prior to
                                        Reduction Act (PRA), 44 U.S.C. 3501 et                  publication of this final rule in the                  Federal Emergency Management
                                        seq., nor does it require any special                   Federal Register. This final rule is not               Agency
                                        considerations under Executive Order                    a ‘‘major rule’’ as defined by 5 U.S.C.
                                        12898, entitled Federal Actions to                      804(2).                                                44 CFR Part 64
                                        Address Environmental Justice in                                                                               [Docket No. FEMA–8007]
                                                                                                List of Subjects in 40 CFR Part 180
                                        Minority Populations and Low-Income
                                        Populations (59 FR 7629, February 16,                     Environmental protection,                            Suspension of Community Eligibility
                                        1994).                                                  Administrative practice and procedure,
                                           Since tolerances and exemptions that                                                                        AGENCY:  Federal Emergency
                                                                                                Agricultural commodities, Pesticides                   Management Agency, DHS.
                                        are established on the basis of a petition              and pests, Reporting and recordkeeping
                                        under section 408(d) of FFDCA, such as                                                                         ACTION: Final rule.
                                                                                                requirements.
                                        the tolerance in this final rule, do not
                                        require the issuance of a proposed rule,                  Dated: January 8, 2008.                              SUMMARY: This rule identifies
                                        the requirements of the Regulatory                      Debra Edwards,                                         communities, where the sale of flood
                                        Flexibility Act (RFA) (5 U.S.C. 601 et                  Director, Office of Pesticide Programs.                insurance has been authorized under
                                        seq.) do not apply.                                                                                            the National Flood Insurance Program
                                           This final rule directly regulates                   ■Therefore, 40 CFR chapter I is                        (NFIP), that are scheduled for
                                        growers, food processors, food handlers,                amended as follows:                                    suspension on the effective dates listed
                                        and food retailers, not States or tribes,                                                                      within this rule because of
                                                                                                PART 180—[AMENDED]                                     noncompliance with the floodplain
                                        nor does this action alter the
                                        relationships or distribution of power                                                                         management requirements of the
                                                                                                ■ 1. The authority citation for part 180
                                        and responsibilities established by                                                                            program. If the Federal Emergency
                                                                                                continues to read as follows:
                                        Congress in the preemption provisions                                                                          Management Agency (FEMA) receives
                                                                                                    Authority: 21 U.S.C. 321(q), 346a and 371.         documentation that the community has
                                        of section 408(n)(4) of FFDCA. As such,
                                        the Agency has determined that this                     ■ 2. Section 180.637 is added to read as               adopted the required floodplain
                                        action will not have a substantial direct               follows:                                               management measures prior to the
                                        effect on States or tribal governments,                                                                        effective suspension date given in this
                                        on the relationship between the national                § 180.637 Mandipropamid; tolerances for                rule, the suspension will not occur and
                                                                                                residues.                                              a notice of this will be provided by
                                        government and the States or tribal
                                        governments, or on the distribution of                    (a) General. Tolerances are                          publication in the Federal Register on a
                                        power and responsibilities among the                    established for residues of the fungicide              subsequent date.
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                                        various levels of government or between                 mandipropamid, 4-chloro-N-[2-(3-                       DATES: Effective Dates: The effective
                                        the Federal Government and Indian                       methoxy-4-(2-propynyloxy)phenyl]                       date of each community’s scheduled
                                        tribes. Thus, the Agency has determined                 ethyl]-alpha-(2-propynyloxy)-                          suspension is the third date (‘‘Susp.’’)
                                        that Executive Order 13132, entitled                    benzeneacetamide in or on the                          listed in the third column of the
                                        Federalism (64 FR 43255, August 10,                     following commodities.                                 following tables.


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