37516 Federal Register / Vol. 62, No. 134 / Monday, July 14, 1997 / Rules and Regulations

Enforcement Fairness Act of 1996, the ENVIRONMENTAL PROTECTION use of special characters and any form EPA submitted a report containing this AGENCY of encryption. Copies of objections and rule and other required information to hearing requests will also be accepted the U.S. Senate, the U.S. House of 40 CFR Part 180 on disks in WordPerfect 5.1 file format Representatives, and the Comptroller [OPP±300515; FRL±5731±3] or ASCII file format. All copies of General of the General Accounting objections and hearing requests in Office prior to publication of this rule in RIN 2070±AB78 electronic form must be identified by today’s Federal Register. This rule is the docket control number [OPP– Fenpropathrin; Pesticide Tolerances not a ‘‘major rule’’ as defined by 5 300515]. No Confidential Business for Emergency Exemptions U.S.C. 804(2). Information (CBI) should be submitted E. Petitions for Judicial Review AGENCY: Environmental Protection through e-mail. Electronic copies of objections and hearing requests on this Under section 307(b)(1) of the CAA, Agency (EPA). ACTION: Final rule. rule may be filed online at many Federal petitions for judicial review of this Depository Libraries. action must be filed in the United States SUMMARY: This regulation establishes a FOR FURTHER INFORMATION CONTACT: By Court of Appeals for the appropriate time-limited tolerance for residues of mail: Olga Odiott, Registration Division circuit by September 12, 1997. Filing a fenpropathrin in or on currants . This 7505C, Office of Pesticide Programs, petition for reconsideration by the action is in response to EPA’s granting Environmental Protection Agency, 401 Administrator of this final rule does not of an emergency exemption under M St., SW., Washington, DC 20460. affect the finality of this rule for the section 18 of the Federal Insecticide, Office location, telephone number, and purposes of judicial review, nor does it Fungicide, and Rodenticide Act e-mail address: Crystal Mall #2, 1921 extend the time within which a petition authorizing use of the pesticide on Jefferson Davis Hwy., Arlington, VA, for judicial review may be filed, and currants in Washington. This regulation (703) 308-9363, e-mail: shall not postpone the effectiveness of establishes a maximum permissible [email protected]. such rule or action. This action may not level for residues of fenpropathrin in be challenged later in proceedings to SUPPLEMENTARY INFORMATION: EPA, on this food commodity pursuant to section its own initiative, pursuant to section enforce its requirements. (See section 408(l)(6) of the Federal Food, Drug, and 307(b)(2).) 408(e) and (l)(6) of the Federal Food, Cosmetic Act, as amended by the Food Drug, and Cosmetic Act (FFDCA), 21 List of Subjects in 40 CFR Part 70 Quality Protection Act of 1996. The U.S.C. 346a(e) and (l)(6), is establishing tolerance will expire and is revoked on Environmental protection, a tolerance for residues of the December 31, 1998. Administrative practice and procedure, insecticide fenpropathrin, in or on Air pollution control, Intergovernmental DATES: This regulation is effective July currants at 15 part per million (ppm). relations, Operating permits, Reporting 14, 1997. Objections and requests for This tolerance will expire and is and recordkeeping requirements. hearings must be received by EPA on or revoked on December 31, 1998. EPA before September 12, 1997. will publish a document in the Federal Dated: June 24, 1997. ADDRESSES: Written objections and Register to remove the revoked U. Gale Hutton, hearing requests, identified by the tolerance from the Code of Federal Acting Regional Administrator. docket control number, [OPP–300515], Regulations. Part 70 chapter I, title 40 of the Code must be submitted to: Hearing Clerk of Federal Regulations is amended as (1900),Environmental Protection I. Background and Statutory Authority follows: Agency, Rm. M3708, 401 M St., SW., The Food Quality Protection Act of Washington, DC 20460. Fees 1996 (FQPA) (Pub. L. 104–170) was PART 70Ð[AMENDED] accompanying objections and hearing signed into law August 3, 1996. FQPA 1. The authority citation for part 70 requests shall be labeled ‘‘Tolerance amends both the Federal Food, Drug, continues to read as follows: Petition Fees’’ and forwarded to: EPA and Cosmetic Act (FFDCA), 21 U.S.C. Headquarters Accounting Operations 301 et seq., and the Federal Insecticide, Authority: 42 U.S.C. 7401, et seq. Branch, OPP (Tolerance Fees), P.O. Box Fungicide, and Rodenticide Act 2. Appendix A to part 70 is amended 360277M, Pittsburgh, PA 15251. A copy (FIFRA), 7 U.S.C. 136 et seq . The FQPA by adding paragraph (b) to the entry for of any objections and hearing requests amendments went into effect Iowa to read as follows: filed with the Hearing Clerk identified immediately. Among other things, Appendix A to Part 70—Approval by the docket control number, [OPP– FQPA amends FFDCA to bring all EPA Status of State and Local Operating 300515], must also besubmitted to: pesticide tolerance-setting activities Permits Programs Public Information and Records under a new section 408 with a new Integrity Branch, Information Resources safety standard and new procedures. * * * * * and Services Division (7506C), Office of These activities are described below and Iowa Pesticide Programs, Environmental discussed in greater detail in the final Protection Agency, 401 M St., SW., rule establishing the time-limited * * * * * tolerance associated with the emergency (b) The Iowa Department of Natural Washington, DC 20460. In person, bring Resources submitted a revised workload a copy of objections and hearing exemption for use of propiconazole on analysis dated April 3, 1997. This fulfills the requests to Rm. 1132, CM #2, 1921 sorghum (61 FR 58135, November 13, final condition of the interim approval Jefferson Davis Hwy., Arlington, VA. 1996)(FRL–5572–9). effective on October 2, 1995, and which A copy of objections and hearing New section 408(b)(2)(A)(i) of the would expire on October 1, 1997. The state requests filed with the Hearing Clerk FFDCA allows EPA to establish a is hereby granted final full approval effective may also be submitted electronically by tolerance (the legal limit for a pesticide September 12, 1997. sending electronic mail (e-mail) to: opp- chemical residue in or on a food) only * * * * * [email protected]. Copies of if EPA determines that the tolerance is [FR Doc. 97–18250 Filed 7–11–97; 8:45 am] objections and hearing requests must be ‘‘safe.’’ Section 408(b)(2)(A)(ii) defines BILLING CODE 6560±50±P submitted as an ASCII file avoiding the ‘‘safe’’ to mean that ‘‘there is a Federal Register / Vol. 62, No. 134 / Monday, July 14, 1997 / Rules and Regulations 37517 reasonable certainty that no harm will in the pith creating a tunnel. Borer the Agency’s Registration Division at the result from aggregate exposure to the damage increases each year when no address provided above. pesticide chemical residue, including control measures are taken. With the III. Risk Assessment and Statutory all anticipated dietary exposures and all cancellation of parathion there are no Findings other exposures for which there is registered pesticides that will provide reliable information.’’ This includes adequate control. The applicant stated EPA performs a number of analyses to exposure through drinking water and in that presently, cane stands have dead determine the risks from aggregate residential settings, but does not include canes ranging from 10 to 30% and if left exposure to pesticide residues. First, occupational exposure. Section uncontrolled, the perennial plantings EPA determines the toxicity of 408(b)(2)(C) requires EPA to give special will be lost. EPA has authorized under pesticides based primarily on consideration to exposure of infants and FIFRA section 18 the use of toxicological studies using laboratory children to the pesticide chemical fenpropathrin on currants for control of animals. These studies address many residue in establishing a tolerance and the currant borer in Washington. After adverse health effects, including (but to ‘‘ensure that there is a reasonable having reviewed the submission, EPA not limited to) reproductive effects, certainty that no harm will result to concurs that emergency conditions exist developmental toxicity, toxicity to the infants and children from aggregate for this state. nervous system, and carcinogenicity. exposure to the pesticide chemical As part of its assessment of this Second, EPA examines exposure to the residue. . . .’’ emergency exemption, EPA assessed the pesticide through the diet (e.g., food and drinking water) and through exposures Section 18 of FIFRA authorizes EPA potential risks presented by residues of that occur as a result of pesticide use in to exempt any Federal or State agency fenpropathrin in or on currants. In residential settings. from any provision of FIFRA, if EPA doing so, EPA considered the new safety determines that ‘‘emergency conditions standard in FFDCA section 408(b)(2), A. Toxicity exist which require such exemption.’’ and EPA decided that the necessary This provision was not amended by 1. Threshold and non-threshold tolerance under FFDCA section 408(l)(6) effects. For many animal studies, a dose FQPA. EPA has established regulations would be consistent with the new safety governing such emergency exemptions response relationship can be standard and with FIFRA section 18. determined, which provides a dose that in 40 CFR part 166. Consistent with the need to move Section 408(l)(6) of the FFDCA causes adverse effects (threshold effects) quickly on the emergency exemption in requires EPA to establish a time-limited and doses causing no observed effects order to address an urgent non-routine tolerance or exemption from the (the ‘‘no-observed effect level’’ or situation and to ensure that the resulting requirement for a tolerance for pesticide ‘‘NOEL’’). food is safe and lawful, EPA is issuing chemical residues in food that will Once a study has been evaluated and result from the use of a pesticide under this tolerance without notice and the observed effects have been an emergency exemption granted by opportunity for public comment under determined to be threshold effects, EPA EPA under section 18 of FIFRA. Such section 408(e), as provided in section generally divides the NOEL from the tolerances can be established without 408(l)(6). Although this tolerance will study with the lowest NOEL by an providing notice or period for public expire and is revoked on December 31, uncertainty factor (usually 100 or more) comment. 1998, under FFDCA section 408(l)(5), to determine the Reference Dose (RfD). Because decisions on section 18- residues of the pesticide not in excess The RfD is a level at or below which related tolerances must proceed before of the amounts specified in the daily aggregate exposure over a lifetime EPA reaches closure on several policy tolerance remaining in or on currants will not pose appreciable risks to issues relating to interpretation and after that date will not be unlawful, human health. An uncertainty factor implementation of the FQPA, EPA does provided the pesticide is applied in a (sometimes called a ‘‘safety factor’’) of not intend for its actions on such manner that was lawful under FIFRA. 100 is commonly used since it is tolerance to set binding precedents for EPA will take action to revoke this assumed that people may be up to 10 the application of section 408 and the tolerance earlier if any experience with, times more sensitive to pesticides than new safety standard to other tolerances scientific data on, or other relevant the test animals, and that one person or and exemptions. information on this pesticide indicate subgroup of the population (such as that the residues are not safe. infants and children) could be up to 10 II. Emergency Exemption for Because this tolerance is being times more sensitive to a pesticide than Fenpropathrin on Currants and FFDCA approved under emergency conditions another. In addition, EPA assesses the Tolerances EPA has not made any decisions about potential risks to infants and children The Washington Department of whether fenpropathrin meets EPA’s based on the weight of the evidence of Agriculture availed itself of the registration requirements for use on the toxicology studies and determines authority to declare the existence of a currants or whether a permanent whether an additional uncertainty factor crisis situation within the state on May tolerance for this use would be is warranted. Thus, an aggregate daily 21, 1997, thereby authorizing use under appropriate. Under these circumstances, exposure to a pesticide residue at or FIFRA Section 18 of fenpropathrin to EPA does not believe that this tolerance below the RfD (expressed as 100% r less control the currant borer (Synanthedon serves as a basis for registration of of the RfD) is generally considered tipuliformes) . Washington has also fenpropathrin by a State for special local acceptable by EPA. EPA generally uses requested a specific exemption for this needs under FIFRA section 24(c). Nor the RfD to evaluate the chronic risks use of fenpropathrin. The applicant does this tolerance serve as the basis for posed by pesticide exposure. For shorter stated that the currant borer is a serious any State other than Washington to use term risks, EPA calculates a margin of pest of currants in Washington. The this pesticide on this crop under section exposure (MOE) by dividing the currant borer adults emerge during mid 18 of FIFRA without following all estimated human exposure into the May in central Washington and lay their provisions of section 18 as identified in NOEL from the appropriate animal eggs on the currant canes over a period 40 CFR part 166. For additional study. Commonly, EPA finds MOEs of 4 to 5 weeks. Newly hatched larvae information regarding the emergency lower than 100 to be unacceptable. This bore into the center of the cane and feed exemption for fenpropathrin, contact 100-fold MOE is based on the same 37518 Federal Register / Vol. 62, No. 134 / Monday, July 14, 1997 / Rules and Regulations rationale as the 100-fold uncertainty of public health. However, for cases in or poses a lifetime cancer risk that is factor. which high-end exposure can greater than approximately one in a Lifetime feeding studies in two reasonably be expected from multiple million, EPA attempts to derive a more species of laboratory animals are sources (e.g. frequent and widespread accurate exposure estimate for the conducted to screen pesticides for homeowner use in a specific pesticide by evaluating additional types cancer effects. When evidence of geographical area), multiple high-end of information (anticipated residue data increased cancer is noted in these risks will be aggregated and presented and/or percent of crop treated data) studies, the Agency conducts a weight as part of the comprehensive risk which show, generally, that pesticide of the evidence review of all relevant assessment/characterization. Since the residues in most foods when they are toxicological data including short-term toxicological endpoint considered in eaten are well below established and mutagenicity studies and structure this assessment reflects exposure over a tolerances. activity relationship. Once a pesticide period of at least 7 days, an additional Percent of crop treated estimates are has been classified as a potential human degree of conservatism is built into the derived from federal and private market carcinogen, different types of risk assessment; i.e., the risk assessment survey data. Typically, a range of assessments (e.g., linear low dose nominally covers 1-7 days exposure, estimates are supplied and the upper extrapolations or MOE calculation based and the toxicological endpoint/NOEL is end of this range is assumed for the on the appropriate NOEL) will be selected to be adequate for at least 7 exposure assessment. By using this carried out based on the nature of the days of exposure. (Toxicity results at upper end estimate of percent of crop carcinogenic response and the Agency’s lower levels when the dosing duration treated, the Agency is reasonably certain knowledge of its mode of action. is increased.) that exposure is not understated for any 2. Differences in toxic effect due to Intermediate-term risk results from significant subpopulation group. exposure duration. The toxicological exposure for 7 days to several months. Further, regional consumption effects of a pesticide can vary with This assessment is handled in a manner information is taken into account different exposure durations. EPA similar to the short-term risk through EPA’s computer-based model considers the entire toxicity data base, assessment. for evaluating the exposure of and based on the effects seen for Chronic risk assessment describes risk significant subpopulations including different durations and routes of which could result from several months several regional groups, to pesticide exposure, determines which risk to a lifetime of exposure. For this residues. For this pesticide, the most assessments should be done to assure assessment, risks are aggregated highly exposed population that the public is adequately protected considering average exposure from all subgroup(non-nursing infants < 1 year from any pesticide exposure scenario. sources for representative population old) was not regionally based. Both short and long durations of subgroups including infants and exposure are always considered. children. IV. Aggregate Risk Assessment and Typically, risk assessments include Determination of Safety B. Aggregate Exposure ‘‘acute’’, ‘‘short-term’’, ‘‘intermediate Consistent with section 408(b)(2)(D), term’’, and ‘‘chronic’’ risks. These In examining aggregate exposure, EPA has reviewed the available assessments are defined by the Agency FFDCA section 408 requires that EPA scientific data and other relevant as follows. take into account available and reliable information in support of this action, Acute risk, by the Agency’s definition, information concerning exposure from EPA has sufficient data to assess the results from 1-day consumption of food the pesticide residue in the food in hazards of fenpropathrin and to make a and water, and reflects toxicity which question, residues in other foods for determination on aggregate exposure, could be expressed following a single which there are tolerances, residues in consistent with section 408(b)(2), for a oral exposure to the pesticide residues. groundwater or surface water that is time-limited tolerance for residues of High end exposure to food and water consumed as drinking water, and other fenpropathrin on currants at 15 ppm. residues are typically assumed. non-occupational exposures through EPA’s assessment of the dietary Short-term risk results from exposure pesticide use in gardens, lawns, or exposures and risks associated with to the pesticide for a period of 1-7 days, buildings (residential and other indoor establishing the tolerance follows. and therefore overlaps with the acute uses). Dietary exposure to residues of a risk assessment. Historically, this risk pesticide in a food commodity are A. Toxicological Profile assessment was intended to address estimated by multiplying the average EPA has evaluated the available primarily dermal and inhalation daily consumption of the food forms of toxicity data and considered its validity, exposure which could result, for that commodity by the tolerance level or completeness, and reliability as well as example, from residential pesticide the anticipated pesticide residue level. the relationship of the results of the applications. However, since enaction of The Theoretical Maximum Residue studies to human risk. EPA has also FQPA, this assessment has been Contribution (TMRC) is an estimate of considered available information expanded to include both dietary and the level of residues consumed daily if concerning the variability of the non-dietary sources of exposure, and each food item contained pesticide sensitivities of major identifiable will typically consider exposure from residues equal to the tolerance. In subgroups of consumers, including food, water, and residential uses when evaluating food exposures, EPA takes infants and children. The nature of the reliable data are available. In this into account varying consumption toxic effects caused by fenpropathrin are assessment, risks from average food and patterns of major identifiable subgroups discussed below. water exposure, and high-end of consumers, including infants and 1. Acute toxicity. An acute dietary residential exposure, are aggregated. children.The TMRC is a ‘‘worst case’’ endpoint was not identified from the High-end exposures from all 3 sources estimate since it is based on the toxicity studies available to the Agency; are not typically added because of the assumptions that food contains therefore this risk assessment was not very low probability of this occurring in pesticide residues at the tolerance level required. most cases, and because the other and that 100% of the crop is treated by 2. Short - and intermediate - term conservative assumptions built into the pesticides that have established toxicity. For short- and intermediate- assessment assure adequate protection tolerances. If the TMRC exceeds the RfD term toxicity endpoints were not Federal Register / Vol. 62, No. 134 / Monday, July 14, 1997 / Rules and Regulations 37519 identified from the available data; using various data sources. The Agency EPA will be able to develop and apply therefore this risk assessment was not then applied the estimated residue scientific principles for better required. levels, in conjunction with appropriate determining which chemicals have a 3. Chronic toxicity. EPA has toxicological endpoints (RfD’s or acute common mechanism of toxicity and established the RfD for fenpropathrin at dietary NOEL’s) and assumptions about evaluating the cumulative effects of 0.025 milligrams/kilogram/day (mg/kg/ body weight and consumption, to such chemicals. The Agency anticipates, day). This RfD is based on a 1-year calculate, for each pesticide, the however, that even as its understanding feeding study in dogs with a NOEL of increment of aggregate risk contributed of the science of common mechanisms 2.5 mg/kg/day and an uncertainty factor by consumption of contaminated water. increases, decisions on specific classes of 100. The lowest observed effect level While EPA has not yet pinpointed the of chemicals will be heavily dependent (LOEL) of 6.25 mg/kg/day was based on appropriate bounding figure for on chemical specific data, much of tremors. exposure from contaminated water, the which may not be presently available. 4. Carcinogenicity. Fenpropathrin has ranges the Agency is continuing to Although at present the Agency does not been classified as to its examine are all below the level that not know how to apply the information carcinogenicity by the EPA. However, would cause fenpropathrin to exceed in its files concerning common studies in two species show no evidence the RfD if the tolerance being mechanism issues to most risk of oncogenicity. considered in this document were assessments, there are pesticides as to B. Exposures and Risks granted. The Agency has therefore which the common mechanism issues concluded that the potential exposures can be resolved. These pesticides 1. From food and feed uses. associated with fenpropathrin in water, include pesticides that are Tolerances have been established (40 even at the higher levels the Agency is toxicologically dissimilar to existing CFR 180.466) for the residues of considering as a conservative upper chemical substances (in which case the fenpropathrin, in or on a variety of raw bound, would not prevent the Agency Agency can conclude that it is unlikely agricultural commodities at levels from determining that there is a that a pesticide shares a common ranging from 0.01 ppm in peanuts to 20 reasonable certainty of no harm if the mechanism of activity with other ppm in peanut hay. Animal commodity tolerance is granted. substances) and pesticides that produce tolerances have been established for 3. From non-dietary exposure. a common toxic metabolite (in which meat, fat, meat by-products, eggs, and Fenpropathrin is currently registered for case common mechanism of activity milk. Risk assessments were conducted use on ornamental plants. EPA believes will be assumed). by EPA to assess dietary exposures and that this use would not fall under a Fenpropathrin is a member of the risks from fenpropathrin as follows: chronic exposure scenario, but may synthetic pyrethroids class of pesticides. Chronic exposure and risk. The constitute a short- and/or intermediate- Other members of this class include chronic dietary risk assessment assumed term exposure scenario. However, no allethrin, tetramethrin, resmethrin, 100% of currants will contain tolerance toxicological endpoints for non-dietary bioresmethrin, phenothrin, fenvalerate, level residues and 100% of the crop will exposure have been identified. permethrin, cyfluthrin, cypermethrin, be treated. All other commodities 4. Cumulative exposure to substances flucythrinate, fluvalinate, tralomethrin, having fenpropathrin tolerances were with common mechanism of toxicity. bifenthrin, tefluthrin, and lambda- assumed to be 100% crop-treated, but Section 408(b)(2)(D)(v) requires that, cyhalothrin. most have received anticipated residue when considering whether to establish, EPA does not have, at this time, refinement. Thus, in making a safety modify, or revoke a tolerance, the available data to determine whether determination for this tolerance, the Agency consider ‘‘available fenpropathrin has a common EPA is taking into account this information’’ concerning the cumulative mechanism of toxicity with other conservative exposure assessment. The effects of a particular pesticide’s substances or how to include this population subgroup with the largest residues and ‘‘other substances that pesticide in a cumulative risk percentage of the RfD occupied is non- have a common mechanism of toxicity.’’ assessment. For the purposes of this nursing infants <1 year old, at 26% of The Agency believes that ‘‘available tolerance action, therefore, EPA has not the RfD. information’’ in this context might assumed that fenpropathrin has a 2. From drinking water. Based on include not only toxicity, chemistry, common mechanism of toxicity with available data used in EPA’s assessment and exposure data, but also scientific other substances. of environmental risk, fenpropathrin is policies and methodologies for C. Aggregate Risks and Determination of persistent and not mobile. There are no understanding common mechanisms of Safety for U.S. Population established Maximum Contaminant toxicity and conducting cumulative risk Level for residues of fenpropathrin in assessments. For most pesticides, Chronic risk. Using the partially drinking water. No health advisory although the Agency has some refined ARC exposure assumptions levels for fenpropathrin in drinking information in its files that may turn out described above, EPA has concluded water have been established. to be helpful in eventually determining that aggregate exposure to fenpropathrin Chronic exposure and risk. Because whether a pesticide shares a common from food will utilize 8% of the RfD for the Agency lacks sufficient water- mechanism of toxicity with any other the U.S. population. The major related exposure data to complete a substances, EPA does not at this time identifiable subgroup with the highest comprehensive drinking water risk have the methodologies to resolve the aggregate exposure is non-nursing assessment for many pesticides, EPA complex scientific issues concerning infants < 1year old at 26% of the RfD has commenced and nearly completed a common mechanism of toxicity in a (discussed below). EPA generally has no process to identify a reasonable yet meaningful way. EPA has begun a pilot concern for exposures below 100% of conservative bounding figure for the process to study this issue further the RfD because the RfD represents the potential contribution of water-related through the examination of particular level at or below which daily aggregate exposure to the aggregate risk posed by classes of pesticides. The Agency hopes dietary exposure over a lifetime will not a pesticide. In developing the bounding that the results of this pilot process will pose appreciable risks to human health. figure, EPA estimated residue levels in increase the Agency’s scientific Despite the potential for exposure to water for a number of specific pesticides understanding of this question such that fenpropathrin in drinking water and 37520 Federal Register / Vol. 62, No. 134 / Monday, July 14, 1997 / Rules and Regulations from non-dietary, non-occupational The developmental (fetal) NOEL was residue of concern is fenpropathrin, per exposure, EPA does not expect the ≤10 mg/kg/day at the highest dose tested se, as specified in 40 CFR 180.466 . aggregate exposure to exceed 100% of [HDT]. Rabbits: The maternal (systemic) B. Analytical Enforcement Methodology the RfD. EPA concludes that there is a NOEL was 4 mg/kg/day. The maternal reasonable certainty that no harm will LOEL of 12 mg/kg/day was based on Adequate enforcement methodology result from aggregate exposure to anorexia, grooming, and flicking of the is available to enforce the tolerance fenpropathrin residues. forepaws. The developmental (fetal) expression. Method RM-22-4 was ≤ successfully validated by EPA on D. Aggregate Cancer Risk for U.S. NOEL was 36 mg/kg/day at the HDT. c. Reproductive toxicity study— Rats: apples. The method has been submitted Population In the 3-generation reproductive toxicity for inclusion in PAM II. Fenpropathrin has not been classified study in rats, the parental (systemic) C. Magnitude of Residues as to its carcinogenicity by the EPA. NOEL was 3 mg/kg/day. The parental However, studies in two species show (systemic) LOEL of 8.9 mg/kg/day was Residues of fenpropathrin per se are no evidence of oncogenicity. based on body tremors with spasmodic not expected to exceed 15 ppm in/on E. Aggregate Risks and Determination of muscle twitches, increased sensitivity currants as a result of this Section 18 Safety for Infants and Children and maternal lethality. The use. Secondary residues are not developmental NOEL was 3.0 mg/kg/ expected in animal commodities as no 1. Safety factor for infants and day. The developmental LOEL of 8.9 feed items are associated with this children— a. In general. In assessing the mg/kg/day was based on body tremors Section 18 use. potential for additional sensitivity of and increased mortality. The infants and children to residues of D. International Residue Limits reproductive (pup) NOEL was 8.9 mg/ fenpropathrin, EPA considered data kg/day. The reproductive LOEL of 8.9 No CODEX MRL has been established from developmental toxicity studies in mg/kg/day was based on increased pup for residues of fenpropathrin in/on the rat and rabbit and a two-generation loss in the F2 generation. currants. A CODEX MRL has been reproduction study in the rat. The d. Pre- and post-natal sensitivity. The established for residues of fenpropathrin developmental toxicity studies are toxicological data base for evaluating in/on the pome fruit crop group at 5.0 designed to evaluate adverse effects on pre- and post-natal toxicity for ppm and grapes at 5.0 ppm. the developing organism resulting from fenpropathrin is complete with respect maternal pesticide exposure during E. Rotational Crop Restrictions. to current data requirements. There are gestation. Reproduction studies provide The results from field rotational crop information relating to pre- and post- no pre- or post-natal toxicity concerns for infants and children, based on the studies indicate that no rotational crop natal effects from exposure to the restrictions or tolerances are required. pesticide, information on the results of the rat and rabbit reproductive capability of mating developmental toxicity studies or the 3- VI. Conclusion animals and data on systemic toxicity. generation reproductive toxicity study Therefore, a time-limited tolerance is FFDCA section 408 provides that EPA in rats. established for residues of fenpropathrin e. Conclusion. EPA concludes that shall apply an additional tenfold margin in currants at 15 ppm. of safety for infants and children in the reliable data support use of the standard case of threshold effects to account for 100-fold uncertainty factor and that an VII. Objections and Hearing Requests pre-and post-natal toxicity and the additional uncertainty factor is not The new FFDCA section 408(g) completeness of the database unless needed to protect infants and children. provides essentially the same process EPA determines that a different margin 2. Chronic risk. Using the for persons to ‘‘object’’ to a tolerance of safety will be safe for infants and conservative exposure assumptions regulation issued by EPA under new children. Margins of safety are described above, EPA has concluded section 408(e) and (l)(6) as was provided incorporated into EPA risk assessments that the percentage of the RfD that will in the old section 408 and in section either directly through use of a MOE be utilized by dietary (food only) 409. However, the period for filing analysis or through using uncertainty exposure to residues of fenpropathrin objections is 60 days, rather than 30 (safety) factors in calculating a dose ranges from 13 % for children (7-12 days. EPA currently has procedural level that poses no appreciable risk to years old), up to 26% for non-nursing regulations which govern the humans. EPA believes that reliable data infants (< 1 year old). EPA generally has submission of objections and hearing support using the standard MOE and no concern for exposures below 100% requests. These regulations will require uncertainty factor (usually 100 for of the RfD because the RfD represents some modification to reflect the new combined inter- and intra-species the level at or below which daily law. However, until those modifications variability)) and not the additional aggregate dietary exposure over a can be made, EPA will continue to use tenfold MOE/uncertainty factor when lifetime will not pose appreciable risks those procedural regulations with EPA has a complete data base under to human health. Despite the potential appropriate adjustments to reflect the existing guidelines and when the for exposure to fenpropathrin in new law. severity of the effect in infants or drinking water, EPA does not expect the Any person may, by September 12, children or the potency or unusual toxic aggregate exposure to exceed 100% of 1997, file written objections to any properties of a compound do not raise the RfD. EPA concludes that there is a aspect of this regulation and may also concerns regarding the adequacy of the reasonable certainty that no harm will request a hearing on those objections. standard MOE/safety factor. result to infants and children from Objections and hearing requests must be b. Developmental toxicity studies— aggregate exposure to fenpropathrin filed with the Hearing Clerk, at the Rats: The maternal (systemic) NOEL residues. address given above (40 CFR 178.20). A was 6 mg/kg/day. The maternal LOEL of V. Other Considerations copy of the objections and/or hearing 10 mg/kg/day was based on death, requests filed with the Hearing Clerk moribundity, ataxia, hypersensitivity, A. Metabolism In Plants and Animals should be submitted to the OPP docket spastic jumping, tremors, convulsions, The nature of the residue in/on tree for this rulemaking. The objections hunched posture, and squinting eyes. fruits is adequately understood. The submitted must specify the provisions Federal Register / Vol. 62, No. 134 / Monday, July 14, 1997 / Rules and Regulations 37521 of the regulation deemed objectionable Electronic comments must be or expanding exemptions might and the grounds for the objections (40 submitted as an ASCII file avoiding the adversely impact small entities and CFR 178.25). Each objection must be use of special characters and any form concluded, as a generic matter, that accompanied by the fee prescribed by of encryption. there is no adverse economic impact. 40 CFR 180.33(i). If a hearing is The official record for this The factual basis for the Agency’s requested, the objections must include a rulemaking, as well as the public generic certification for tolerance statement of the factual issues on which version, as described above will be kept acations published on May 4, 1981 (46 a hearing is requested, the requestor’s in paper form. Accordingly, EPA will FR 24950), and was provided to the contentions on such issues, and a transfer any copies of objections and Chief Counsel for Advocacy of the Small summary of any evidence relied upon hearing requests received electronically Business Administration. by the requestor (40 CFR 178.27). A into printed, paper form as they are X. Submission to Congress and the request for a hearing will be granted if received and will place the paper copies General Accounting Office the Administrator determines that the in the official rulemaking record which material submitted shows the following: will also include all comments Under 5 U.S.C. 801(a)(1)(A), as added There is genuine and substantial issue submitted directly in writing. The by the Small Business Regulatory of fact; there is a reasonable possibility official rulemaking record is the paper Enforcement Fairness Act of 1996, the that available evidence identified by the record maintained at the Virginia Agency has submitted a report requestor would, if established, resolve address in ‘‘ADDRESSES’’ at the containing this rule and other required one or more of such issues in favor of beginning of this document. information to the U.S. Senate, the U.S. the requestor, taking into account IX. Regulatory Assessment House of Representatives, and the uncontested claims or facts to the Requirements Comptroller General of the General contrary; and resolution of the factual Accounting Office prior to publication issues in the manner sought by the This final rule establishes a time- of this rule in today’s Federal Register. limited tolerance under FFDCA section requestor would be adequate to justify This is not a ‘‘major rule’’ as defined by 408(l)(6). The Office of Management and the action requested (40 CFR 178.32). 5 U.S.C. 804(2). Information submitted in connection Budget (OMB) has exempted these types with an objection or hearing request of actions from review under Executive List of Subjects in 40 CFR Part 180 Order 12866, entitled Regulatory may be claimed confidential by marking Environmental protection, Planning and Review (58 FR 51735, any part or all of that information as Administrative practice and procedure, October 4, 1993). This final rule does Confidential Business Information (CBI). Agricultural commodities, Pesticides not contain any information collections Information so marked will not be and pests, Reporting and recordkeeping subject to OMB approval under the disclosed except in accordance with requirements. procedures set forth in 40 CFR part 2. Paperwork Reduction Act (PRA), 44 Dated: July 9, 1997. A copy of the information that does not U.S.C. 3501 et seq., or impose any contain CBI must be submitted for enforceable duty or contain any James Jones. inclusion in the public record. unfunded mandate as described under Acting Director, Registration Division, Office Information not marked confidential Title II of the Unfunded Mandates of Pesticide Programs. may be disclosed publicly by EPA Reform Act of 1995 (UMRA) (Pub. L. Therefore, 40 CFR chapter I is without prior notice. 104-4). Nor does it require any prior amended as follows: consultation as specified by Executive VIII. Public Docket Order 12875, entitled Enhancing the PART 180Ð[AMENDED] Intergovernmental Partnership (58 FR EPA has established a record for this 58093, October 28, 1993), or special 1. The authority citation for part 180 rulemaking under docket control considerations as required by Executive continues to read as follows: number [OPP–300515] (including any Order 12898, entitled Federal Actions to Authority : 21 U.S.C. 346a and 371. comments and data submitted Address Environmental Justice in electronically). A public version of this Minority Populations and Low-Income 2. Section 180.466 is amended by record, including printed, paper Populations (59 FR 7629, February 16, designating the existing text as versions of electronic comments, which 1994), or require OMB review in paragraph (a) and adding a heading, by does not include any information accordance with Executive Order 13045, adding paragraph (b) and by adding and claimed as CBI, is available for entitled Protection of Children from reserving paragraphs (c) and (d) to read inspection from 8:30 a.m. to 4 p.m., Environmental Health Risks and Safety as follows: Monday through Friday, excluding legal Risks (62 FR 19885, April 23, 1997). § 180.466 Fenpropathrin. holidays. The public record is located in In addition, since tolerances and Room 1132 of the Public Information exemptions that are established under (a) General .*** and Records Integrity Branch, FFDCA section 408 (l)(6), such as the (b) Section 18 emergency exemptions. Information Resources and Services tolerance in this final rule, do not Time-limited tolerances are established Division (7506C), Office of Pesticide require the issuance of a proposed rule, for residues of the herbicide Programs, Environmental Protection the requirements of the Regulatory fenpropathrin in connection with use of Agency, Crystal Mall #2, 1921 Jefferson Flexibility Act (RFA) (5 U.S.C. 601 et the pesticide under section 18 Davis Hwy., Arlington, VA. seq.) do not apply. Nevertheless, the emergency exemptions granted by EPA. Electronic comments may be sent Agency has previously assessed whether The tolerance will expire and is revoked directly to EPA at: establishing tolerances, exemptions on the date specified in the following [email protected]. from tolerances, raising tolerance levels table. 37522 Federal Register / Vol. 62, No. 134 / Monday, July 14, 1997 / Rules and Regulations

Commodity Parts per million Expiration/Revocation Date

Currants ...... 15 December 31, 1998

(c) Tolerances with regional Regional Docket Office. The contact for Appendix BÐ[Amended] registrations. [Reserved] the Regional Docket Office is Jan (d) Indirect or inadvertent residues. Pfundheller (H–7J), U.S. EPA, Region V, 2. Table 1 of Appendix B to part 300 [Reserved] 77 W. Jackson Blvd., Chicago, IL 60604, is amended by removing the Site ‘‘Tri- (312) 353–5821. State Plating Superfund Site, Columbus, [FR Doc. 97–18560 Filed 7–11–97; 8:45 am] Indiana.’’ BILLING CODE 6560±50±F SUPPLEMENTARY INFORMATION: The site to be deleted from the NPL is: Tri-State [FR Doc. 97–17733 Filed 7–11–97; 8:45 am] Plating Superfund Site located in BILLING CODE 6560±50±U ENVIRONMENTAL PROTECTION Columbus, Indiana. A Notice of Intent to AGENCY Delete for this site was published May 22, 1997 (62 FR 26463). The closing date 40 CFR Part 300 for comments on the Notice of Intent to FEDERAL COMMUNICATIONS COMMISSION [FRL±5854±3] Delete was June 21, 1997. EPA received no comments and therefore no 47 CFR Part 73 National Oil and Hazardous Responsiveness Summary was prepared. Substances Contingency Plan; The EPA identifies sites which appear [MM Docket No. 97±58; RM±8998] National Priorities List Update to present a significant risk to public AGENCY: Environmental Protection health, welfare, or the environment and Radio Broadcasting Services; Agency. it maintains the NPL as the list of those Randolph, UT sites. Sites on the NPL may be the ACTION: Notice of deletion of the Tri- subject of Hazardous Substance AGENCY: Federal Communications State Plating Superfund Site from the Response Trust Fund (Fund-) financed Commission. National Priorities List (NPL). remedial actions. Any site deleted from ACTION: Final rule. SUMMARY: The Environmental Protection the NPL remains eligible for Fund- Agency (EPA) announces the deletion of financed remedial actions in the SUMMARY: The Commission, at the the Tri-State Plating Superfund Site in unlikely event that conditions at the site request of Vixon Valley Broadcasting, Indiana from the National Priorities List warrant such action. Section allots Channel 272A to Randolph, Utah, (NPL). The NPL is Appendix B of 40 300.425(e)(3) of the NCP states that as the community’s first local aural CFR part 300 which is the National Oil Fund-financed actions may be taken at transmission service. See 62 FR 07983, and Hazardous Substances Contingency sites deleted from the NPL in the February 21, 1997. Channel 272A can be Plan (NCP), which EPA promulgated unlikely event that conditions at the site allotted to Randolph, Utah, in pursuant to Section 105 of the warrant such action. Deletion of a site compliance with the Commission’s Comprehensive Environmental from the NPL does not affect responsible minimum distances separation Response, Compensation, and Liability party liability or impede agency efforts requirements without the imposition of Act of 1980 (CERCLA), as amended. to recover costs associated with a site restriction. The coordinates for This action is being taken by EPA and response efforts. Channel 272A at Randolph are 41–39– 54 NL and 111–11–12 WL. With this the State of Indiana, because it has been List of Subjects in 40 CFR Part 300 determined that Responsible Parties action, this proceeding is terminated. have implemented all appropriate Environmental protection, Air DATES: Effective August 11, 1997. The response actions required. Moreover, pollution control, Chemicals, Hazardous window period for filing applications EPA and the State of Indiana have substances, Hazardous waste, will open on August 11, 1997, and close determined that remedial actions Intergovernmental relations, Penalties, on September 11, 1997. conducted at the site to date remain Reporting and record keeping FOR FURTHER INFORMATION CONTACT: Pam protective of public health, welfare, and requirements, Superfund, Water Blumenthal, Mass Media Bureau, (202) the environment. pollution control, Water supply. 418–2180. EFFECTIVE DATE: July 14, 1997. Dated: June 24, 1997. SUPPLEMENTARY INFORMATION: This is a FOR FURTHER INFORMATION CONTACT: Bill Michelle D. Jordan, synopsis of the Commission’s Report Bolen at (312) 353–6316 (SR–6J), Acting Regional Administrator, U.S. EPA, and Order, MM Docket No. 97–58, Remedial Project Manager or Gladys Region V. adopted June 18, 1997, and released Beard at (312) 886–7253, Associate 40 CFR part 300 is amended as June 27, 1997. The full text of this Remedial Project Manager, Superfund follows: Commission decision is available for Division, U.S. EPA—Region V, 77 West inspection and copying during normal Jackson Blvd., Chicago, IL 60604. PART 300Ð[AMENDED] business hours in the FCC Reference Information on the site is available at Center (Room 239), 1919 M Street, NW, the local information repository located 1. The authority citation for Part 300 Washington, DC. The complete text of at: The Bartholomew County Health continues to read as follows: this decision may also be purchased Department, 440 3rd St., Suite 303, Authority: 33 U.S.C. 1321(c)(2); 42 U.S.C. from the Commission’s copy contractor, Columbus, IN 47201–6798. Requests for 9601–9657; E.O. 12777, 56 FR 54757, 3 CFR, ITS, Inc., (202) 857–3800, 2100 M comprehensive copies of documents 1991 Comp.; p.351; E.O. 12580, 52 FR 2923, Street, NW, Suite 140, Washington, DC should be directed formally to the 3 CFR, 1987 Comp.; p. 193. 20037.