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703 Nonprofit Standard Mail and an Electronic Manifesting Solution for 10.4.2 Nonlocal Zone Other Unique Eligibility Parcels must also establish a user Nonlocal zones are defined as: account and mailer agreement with * * * * * * * * * * USPS in the Business Customer [Add new item 10.4.2i as follows:] 2.0 Oversea Military Mail Gateway at https://gateway.usps.com. h. Zone 9 includes the destinations * * * * * * * * * * listed in DMM 608.2.2 (Republic of Palau, Federated States of Micronesia, 2.6 Priority Mail Express Military 2.6 Priority Mail Express Manifesting and Republic of the Marshall Islands). Service (PMEMS) Agreements * * * * * * * * * * * * * * * Index and Appendices [Revise the heading and text of 2.6.6 2.6.2 What May Be Manifested as follows:] * * * * * [Revise the first sentence of 2.6.2 as 2.6.6 To APO/FPO and DPO follows:] Forms Glossary Destinations PMEM may be used to pay postage for [Delete the following forms:] Under PMEMS, items mailed to APO/ Priority Mail Express and Priority Mail PS Form 1509, Sender’s Application FPO and DPO destinations (from the Express Military Service to qualifying for Recall of Mail United States) are available for delivery APO/FPO and DPO addresses.*** PS Form 5541, Pickup Service at the destination APO/FPO or DPO Post * * * * * Statement—PME, GXG, PM, or Standard Office by 3 p.m. on the designated Post delivery day unless the designated 2.8 Applications, Agreement PS Form 5625, Priority Mail Express delivery day is a weekend or holiday; in Renewals, Modifications, Suspensions, Custom Designed Service Receipt such cases, the item is available for and Cancellations PS Form 5637, USPS Corporate delivery on the next business day. * * * The application for PMEM Account/Custom Designed Agreement [Revise the heading and text of 2.6.7 must be accompanied by the following: * * * * * as follows:] [Revise item 2.8.1b as follows:] We will publish an appropriate b. A copy of Form 5639 showing that amendment to 39 CFR part 111 to reflect 2.6.7 From APO/FPO and DPO a USPS Corporate Account has been these changes. Destinations established. Stanley F. Mires, Under PMEMS, items mailed from * * * * * APO/FPO and DPO locations (going to Attorney, Legal Policy and Legislative Advice. the United States) are delivered to an 18.0 Priority Mail Express Open and [FR Doc. 2013–27728 Filed 11–19–13; 8:45 am] addressee within the delivery area of the Distribute and Priority Mail Open and BILLING CODE 7710–12–P destination Post Office by 3 p.m. on the Distribute designated delivery day. 18.1 Prices and Fees ENVIRONMENTAL PROTECTION 2.6.8 Mailing Label 18.1.1 Basis of Price AGENCY [Revise the first sentence of 2.6.8 as The basis of price for Priority Mail follows:] Express and Priority Mail Open and 40 CFR Part 180 For each PMEMS item, the mailer Distribute is as follows: [EPA–HQ–OPP–2012–0899; FRL–9902–44] must complete mailing Label 11–B or [Revise the first sentence of item Label 11–F.*** 18.1.1a as follows:] Fenpropathrin; Pesticide Tolerances a. Priority Mail Express postage is * * * * * AGENCY: Environmental Protection based on the zone and weight of the Agency (EPA). 705 Advanced Preparation and contents of the Open and Distribute ACTION: Special Postage Payment Systems shipment. * * * Final rule. * * * * * * * * * * SUMMARY: This regulation establishes 2.0 Manifest Mailing System [Revise the first sentence of item tolerances for residues of fenpropathrin 18.1.1c as follows:] in or on multiple commodities which * * * * * c. Except as provided above, Priority are identified and discussed later in this 2.4 Authorization Mail postage is based on the zone and document. This regulation additionally weight of the contents of the Open and removes several permanent tolerances 2.4.1 Application Distribute shipment. as they will be superseded by the [Revise the text of 2.4.1 as follows:] * * * * * tolerances established by this document. The mailer must submit an MMS [Delete 19.0, Express Mail Reshipment Interregional Research Project Number 4 application and supporting Service, in its entirety. Renumber 705.20 (IR–4) requested these tolerances under documentation as specified on the through 705.26 as 705.19 through the Federal Food, Drug, and Cosmetic application to the postmaster of each 705.25.] Act (FFDCA). Post Office where mailings will be * * * * * DATES: This regulation is effective deposited and under the publications as November 20, 2013. Objections and follows: 708 Technical Specifications requests for hearings must be received a. Publication 401, Guide to the * * * * * on or before January 21, 2014, and must Manifest Mailing System, contains an be filed in accordance with the application to mail using an MMS. 10.0 Postal Zones instructions provided in 40 CFR part b. Publication 205, Electronic * * * * * 178 (see also Unit I.C. of the Verification System Technical Guide, SUPPLEMENTARY INFORMATION). provides the eVS application 10.4 Specific Zones ADDRESSES: The docket for this action, procedures for mailers. Customers using * * * * * identified by docket identification (ID)

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number EPA–HQ–OPP–2012–0899, is and may also request a hearing on those million (ppm); barley, hay at 3.0 ppm; available at http://www.regulations.gov objections. You must file your objection barley, straw at 2.0 ppm; berry, low- or at the Office of Pesticide Programs or request a hearing on this regulation growing, subgroup 13–07G at 2.0 ppm; Regulatory Public Docket (OPP Docket) in accordance with the instructions bushberry subgroup 13–07B at 3.0 ppm; in the Environmental Protection Agency provided in 40 CFR part 178. To ensure fruit, citrus, group 10–10 at 2.0 ppm; Docket Center (EPA/DC), EPA West proper receipt by EPA, you must fruit, pome, group 11–10 at 5.0 ppm; Bldg., Rm. 3334, 1301 Constitution Ave. identify docket ID number EPA–HQ– fruit, small vine climbing, except fuzzy NW., Washington, DC 20460–0001. The OPP–2012–0899 in the subject line on kiwifruit, subgroup 13–07F at 5.0 ppm; Public Reading Room is open from 8:30 the first page of your submission. All and vegetable, fruiting, group 8–10 at a.m. to 4:30 p.m., Monday through objections and requests for a hearing 1.0 ppm. The petition additionally Friday, excluding legal holidays. The must be in writing, and must be requested the removal of the following telephone number for the Public received by the Hearing Clerk on or established tolerances in 40 CFR Reading Room is (202) 566–1744, and before January 21, 2014. Addresses for 180.466 for fenpropathrin as they will the telephone number for the OPP mail and hand delivery of objections be superseded by new tolerances, if Docket is (703) 305–5805. Please review and hearing requests are provided in 40 established: Fruit, citrus, group 10; fruit, the visitor instructions and additional CFR 178.25(b). pome, group 11; bushberry subgroup information about the docket available In addition to filing an objection or 13B; grape; juneberry; salal; strawberry; at http://www.epa.gov/dockets. hearing request with the Hearing Clerk and vegetable, fruiting, group 8. FOR FURTHER INFORMATION CONTACT: Lois as described in 40 CFR part 178, please That document referenced a summary Rossi, Registration Division (7505P), submit a copy of the filing (excluding of the petition prepared on behalf of IR– Office of Pesticide Programs, any Confidential Business Information 4 by Valent USA Corporation, the Environmental Protection Agency, 1200 (CBI)) for inclusion in the public docket. registrant, which is available in the Pennsylvania Ave. NW., Washington, Information not marked confidential docket, http://www.regulations.gov. There were no comments received in DC 20460–0001; telephone number: pursuant to 40 CFR part 2 may be response to the notice of filing. (703) 305–7090; email address: disclosed publicly by EPA without prior Based upon review of the data [email protected]. notice. Submit the non-CBI copy of your objection or hearing request, identified supporting the petition, EPA has SUPPLEMENTARY INFORMATION: by docket ID number EPA–HQ–OPP– determined that the established I. General Information 2012–0899, by one of the following tolerance for lingonberry will also be methods: removed. The reason for this change is A. Does this action apply to me? • Federal eRulemaking Portal: http:// explained in Unit IV.C You may be potentially affected by www.regulations.gov. Follow the online III. Aggregate Risk Assessment and this action if you are an agricultural instructions for submitting comments. Determination of Safety producer, food manufacturer, or Do not submit electronically any pesticide manufacturer. The following information you consider to be CBI or Section 408(b)(2)(A)(i) of FFDCA list of North American Industrial other information whose disclosure is allows EPA to establish a tolerance (the Classification System (NAICS) codes is restricted by statute. legal limit for a pesticide chemical not intended to be exhaustive, but rather • Mail: OPP Docket, Environmental residue in or on a food) only if EPA provides a guide to help readers Protection Agency Docket Center (EPA/ determines that the tolerance is ‘‘safe.’’ determine whether this document DC), (28221T), 1200 Pennsylvania Ave. Section 408(b)(2)(A)(ii) of FFDCA applies to them. Potentially affected NW., Washington, DC 20460–0001. defines ‘‘safe’’ to mean that ‘‘there is a entities may include: • Hand Delivery: To make special reasonable certainty that no harm will • Crop production (NAICS code 111). arrangements for hand delivery or result from aggregate exposure to the • Animal production (NAICS code delivery of boxed information, please pesticide chemical residue, including 112). follow the instructions at http:// all anticipated dietary exposures and all • Food manufacturing (NAICS code www.epa.gov/dockets/contacts.html. other exposures for which there is 311). Additional instructions on reliable information.’’ This includes • Pesticide manufacturing (NAICS commenting or visiting the docket, exposure through drinking water and in code 32532). along with more information about residential settings, but does not include dockets generally, is available at occupational exposure. Section B. How can I get electronic access to http://www.epa.gov/dockets. 408(b)(2)(C) of FFDCA requires EPA to other related information? give special consideration to exposure II. Summary of Petitioned-For You may access a frequently updated of infants and children to the pesticide Tolerances electronic version of EPA’s tolerance chemical residue in establishing a regulations at 40 CFR part 180 through In the Federal Register of February tolerance and to ‘‘ensure that there is a the Government Printing Office’s e-CFR 15, 2013 (78 FR 11126) (FRL–9378–4), reasonable certainty that no harm will site at http://www.ecfr.gov/cgi-bin/text- EPA issued a document pursuant to result to infants and children from idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ FFDCA section 408(d)(3), 21 U.S.C. aggregate exposure to the pesticide 40tab_02.tpl. To access the OPPTS test 346a(d)(3), announcing the filing of a chemical residue. . . .’’ guidelines referenced in this document pesticide petition (PP 2E8107) by IR– Consistent with FFDCA section electronically, please go to http:// 4,500 College Rd. East, Suite 201W., 408(b)(2)(D), and the factors specified in www.epa.gov/ocspp and select ‘‘Test Princeton, NJ 08540. The petition FFDCA section 408(b)(2)(D), EPA has Methods and Guidelines.’’ requested that 40 CFR 180.466 be reviewed the available scientific data amended by establishing tolerances for and other relevant information in C. How can I file an objection or hearing residues of the insecticide support of this action. EPA has request? fenpropathrin, alpha-cyano-3- sufficient data to assess the hazards of Under FFDCA section 408(g), 21 phenoxybenzyl 2,2,3,3- and to make a determination on U.S.C. 346a, any person may file an tetramethylcyclopropanecarboxylate, in aggregate exposure for fenpropathrin objection to any aspect of this regulation or on barley, grain at 0.04 parts per including exposure resulting from the

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tolerances established by this action. In developmental toxicity studies in calculate a safe exposure level— EPA’s assessment of exposures and risks rats and rabbits, maternal toxicity generally referred to as a population- associated with fenpropathrin follows. included neurological effects such as adjusted dose (PAD) or a reference dose ataxia, sensitivity to external stimuli, (RfD)—and a safe margin of exposure A. Toxicological Profile tremors in the rat, and flicking of (MOE). For non-threshold risks, the EPA has evaluated the available forepaws in the rabbit. Developmental Agency assumes that any amount of toxicity data and considered its validity, effects were limited to incomplete or exposure will lead to some degree of completeness, and reliability as well as asymmetrical ossification of sternebrae risk. Thus, the Agency estimates risk in the relationship of the results of the at the maternally toxic dose in the rat. terms of the probability of an occurrence studies to human risk. EPA has also There were no developmental effects in of the adverse effect expected in a considered available information the rabbit. In a 3-generation lifetime. For more information on the concerning the variability of the reproduction study in the rat, maternal general principles EPA uses in risk sensitivities of major identifiable and offspring effects were observed at characterization and a complete subgroups of consumers, including the mid- and high-dose. At the high description of the risk assessment infants and children. dose, maternal effects included process, see http://www.epa.gov/ Fenpropathrin is a member of the increased deaths and clinical signs of pesticides/factsheets/riskassess.htm. pyrethroid class of insecticides. toxicity (tremors, muscle twitches, and A summary of the toxicological Pyrethroids have historically been increased sensitivity) during lactation. endpoints for fenpropathrin used for classified into two groups, Type I and Pup deaths were noted at this level. At human risk assessment is discussed in Type II, based on chemical structure the mid-dose, minimal signs of Unit III.B. of the final rule published in and toxicological effects. Type I treatment-related effects were observed the Federal Register of November 28, pyrethroids, which lack an alpha-cyano for both adults and pups, reducing 2012 (77 FR 70902) (FRL–9366–1). moiety, induce in rats a syndrome concern for quantitative or qualitative C. Exposure Assessment consisting of aggressive sparring, altered sensitivity. There were no indications of immunotoxicity in any of the guideline 1. Dietary exposure from food and sensitivity to external stimuli, feed uses. In evaluating dietary hyperthermia, and fine tremor studies, including the immunotoxicity study in rats. exposure to fenpropathrin, EPA progressing to whole-body tremor and considered exposure under the prostration (T-syndrome). Type II There was no evidence of carcinogenicity in either the rat or petitioned-for tolerances as well as all pyrethroids, which contain an alpha- mouse long-term dietary studies, nor existing fenpropathrin tolerances in 40 cyano moiety, produce in rats a was there any mutagenic activity in CFR 180.466. EPA assessed dietary syndrome that includes pawing, bacteria or cultured mammalian cells. exposures from fenpropathrin in food as burrowing, salivation, hypothermia, and Fenpropathrin has been classified as follows: coarse tremors leading to ‘‘not likely to be carcinogenic to i. Acute exposure. Quantitative acute choreoathetosis (CS-syndrome). humans.’’ Specific information on the dietary exposure and risk assessments Fenpropathrin is a mixed-type studies received and the nature of the are performed for a food-use pesticide, pyrethroid because the biochemical adverse effects caused by fenpropathrin if a toxicological study has indicated the responses and resulting clinical signs of as well as the toxicological points of possibility of an effect of concern neurotoxicity are intermediate between departure (POD) derived from the BMDL occurring as a result of a 1-day or single those of Type I and Type II pyrethroids. (statistical lower confidence limit on the exposure. Such effects were identified The adverse outcome pathway shared dose at the benchmark dose) from the for fenpropathrin. In estimating acute by pyrethroids involves the ability to toxicity studies can be found at http:// dietary exposure, EPA used food interact with voltage-gated sodium www.regulations.gov in document consumption information from the channels in the central and peripheral ‘‘Fenpropathrin. Human Health Risk United States Department of Agriculture nervous systems, leading to changes in Assessment for the Proposed Section 3 (USDA) 2003–2008 National Health and neuron firing and, ultimately, Registration on Barley and the Request Nutrition Examination Survey, What We neurotoxicity. to Update Several Existing Crop Groups Eat in America, (NHANES/WWEIA). As Fenpropathrin exhibits high acute with Revised Crop Grouping to residue levels in food, EPA utilized toxicity via the oral and dermal routes Definitions’’ starting at p. 12, in docket percent crop treated (PCT) estimates and but low toxicity via the inhalation route ID number EPA–HQ–OPP–2012–0899. tolerance level residues, distributions of of exposure. Fenpropathrin is a mild eye field trial values, and distributions of irritant, but does not cause dermal B. Toxicological Points of Departure/ Pesticide Data Program (PDP) irritation or skin sensitization. Levels of Concern monitoring data. Toxicological effects characteristic of Once a pesticide’s toxicological Residue distributions were used for pyrethroids were seen in most of the profile is determined, EPA identifies the commodities that made the most experimental toxicology studies toxicological POD and levels of concern significant contributions to the risk including the acute, subchronic, and to use in evaluating the risk posed by estimates (i.e., the ‘‘risk drivers’’). developmental neurotoxicity studies, human exposure to the pesticide. For Monitoring data were used for risk subchronic studies in the rat and dog, hazards that have a threshold below drivers when they were available; the chronic carcinogenicity study in the which there is no appreciable risk, the however, field trial data were used for rat, the developmental studies in the rat toxicological POD is used as the basis the remaining risk drivers. Distributions and rabbit, and in the 3-generation for derivation of reference values for of monitoring data values were used for reproduction study in rats. Tremors risk assessment. For fenopropathrin, the the following risk drivers: Apple juice, were the most common indication of PODs are developed based on a careful apples, blackberries, blueberries, neurotoxicity; however, ataxia, analysis of the doses in each broccoli, cauliflower, Chinese mustard increased sensitivity (e.g., heightened toxicological study; a benchmark dose cabbage, grape juice, grapes, response) to external stimuli, analysis was conducted to derive the huckleberries, oranges, pears, convulsions, and increased auditory BMDL. Uncertainty/safety factors are raspberries, squash, strawberries, startle response were also observed. used in conjunction with the POD to tangerines, and watermelon. Monitoring

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data from the years 2007 through 2010, • Condition a: The data used are consumption information and inclusive, were used. Broccoli PDP data reliable and provide a valid basis to consumption information for significant were translated to Chinese mustard show what percentage of the food subpopulations is taken into account cabbage and cauliflower. Orange PDP derived from such crop is likely to through EPA’s computer-based model data were translated to tangerines. contain the pesticide residue. for evaluating the exposure of Blueberry PDP data were translated to • Condition b: The exposure estimate significant subpopulations including blackberries, huckleberries, and does not underestimate exposure for any several regional groups. Use of this raspberries. Finally, strawberry PDP significant subpopulation group. consumption information in EPA’s risk • data were translated to cranberries. Condition c: Data are available on assessment process ensures that EPA’s Distributions of field trial data were pesticide use and food consumption in exposure estimate does not understate used for apricot juice, apricots, Brussels a particular area, the exposure estimate exposure for any significant sprouts, cabbage, cherries, cherry juice, does not understate exposure for the subpopulation group and allows the Chinese napa cabbage, cucumbers, population in such area. Agency to be reasonably certain that no grapefruit, grapefruit juice, guava, In addition, the Agency must provide regional population is exposed to mango, mango juice, nectarines, olives, for periodic evaluation of any estimates residue levels higher than those papaya, papaya juice, passion fruit, used. To provide for the periodic estimated by the Agency. Other than the passion fruit juice, peach juice, peaches, evaluation of the estimate of PCT as data available through national food plums, prune plum juice, prune plums, required by FFDCA section 408(b)(2)(F), consumption surveys, EPA does not tomato juice, and tomatoes. For most EPA may require registrants to submit have available reliable information on processed commodities, DEEM (Dietary data on PCT. the regional consumption of food to The Agency estimated the PCT for Exposure Evaluation Model) default which fenpropathrin may be applied in existing uses as follows: Apples, 15%; processing factors were used for those a particular area. apricots 2.5%; blueberries, 2.5%; commodities for which they were 2. Dietary exposure from drinking broccoli, 2.5%; Brussels sprouts, 10%; available. In some cases, empirical water. The Agency used screening level cabbage, 2.5%; cauliflower, 2.5%; processing factors were used. water exposure models in the dietary cherries, 5%; cotton, 2.5%; cucumbers, exposure analysis and risk assessment ii. Chronic exposure. Based on the 2.5%; grapefruit, 35%; grapes, 10%; data summarized in Unit III.A., there is for fenpropathrin in drinking water. nectarines, 2.5%; oranges, 35%; These simulation models take into no increase in hazard from repeated peaches, 2.5%; pears, 10%; plums, exposures to fenpropathrin; the acute account data on the physical, chemical, 2.5%; prune plums, 2.5%; squash, and fate/transport characteristics of dietary exposure assessment is 2.5%; strawberries, 50%; tangerines, protective for chronic dietary exposures fenpropathrin. Further information 15%; tomatoes, 10%; and watermelons, regarding EPA drinking water models because acute exposure levels are higher 2.5%. than chronic exposure levels. used in pesticide exposure assessment In most cases, EPA uses available data can be found at http://www.epa.gov/ Accordingly, a dietary exposure from United States Department of oppefed1/models/water/index.htm. assessment for the purpose of assessing Agriculture/National Agricultural Based on the First Index Reservoir chronic dietary risk was not conducted. Statistics Service (USDA/NASS), Screening Tool (FIRST), Screening iii. Cancer. Based on the data proprietary market surveys, and the Concentration in Ground Water (SCI– summarized in Unit III.A., EPA has National Pesticide Use Database for the GROW) models, the estimated drinking concluded that fenpropathrin does not chemical/crop combination for the most water concentrations (EDWCs) of pose a cancer risk to humans. Therefore, recent 6–7 years. EPA uses an average fenpropathrin for acute exposures are a dietary exposure assessment for the PCT for chronic dietary risk analysis. estimated to be 10.3 parts per billion purpose of assessing cancer risk is The average PCT figure for each existing (ppb) for surface water and 0.005 ppb unnecessary. use is derived by combining available for ground water. iv. Anticipated residue and PCT public and private market survey data Modeled estimates of drinking water information. Section 408(b)(2)(E) of for that use, averaging across all concentrations were directly entered FFDCA authorizes EPA to use available observations, and rounding to the into the dietary exposure model. For data and information on the anticipated nearest 5%, except for those situations acute dietary risk assessment, the water residue levels of pesticide residues in in which the average PCT is less than concentration value of 10.3 ppb was food and the actual levels of pesticide one. In those cases, 1% is used as the used to assess the contribution to residues that have been measured in average PCT and 2.5% is used as the drinking water. food. If EPA relies on such information, maximum PCT. EPA uses a maximum 3. From non-dietary exposure. The EPA must require pursuant to FFDCA PCT for acute dietary risk analysis. The term ‘‘residential exposure’’ is used in section 408(f)(1) that data be provided 5 maximum PCT figure is the highest this document to refer to non- years after the tolerance is established, observed maximum value reported occupational, non-dietary exposure modified, or left in effect, demonstrating within the recent 6 years of available (e.g., for lawn and garden pest control, that the levels in food are not above the public and private market survey data indoor pest control, termiticides, and levels anticipated. For the present for the existing use and rounded up to flea and tick control on pets). action, EPA will issue such data call-ins the nearest multiple of 5%. Fenpropathrin is not registered for any as are required by FFDCA section The Agency believes that the three specific use patterns that would result 408(b)(2)(E) and authorized under conditions discussed in Unit III.C.1.iv. in residential exposure. FFDCA section 408(f)(1). Data will be have been met. With respect to 4. Cumulative effects from substances required to be submitted no later than Condition a, PCT estimates are derived with a common mechanism of toxicity. 5 years from the date of issuance of from Federal and private market survey Section 408(b)(2)(D)(v) of FFDCA these tolerances. data, which are reliable and have a valid requires that, when considering whether Section 408(b)(2)(F) of FFDCA states basis. The Agency is reasonably certain to establish, modify, or revoke a that the Agency may use data on the that the percentage of the food treated tolerance, the Agency consider actual percent of food treated for is not likely to be an underestimation. ‘‘available information’’ concerning the assessing dietary risk only if: As to Conditions b and c, regional cumulative effects of a particular

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pesticide’s residues and ‘‘other D. Safety Factor for Infants and pharmacodynamics of homologous substances that have a common Children sodium channel isoforms in rats and mechanism of toxicity.’’ 1. In general. Section 408(b)(2)(C) of humans. The Agency is required to consider FFDCA provides that EPA shall apply 3. Conclusion. EPA is reducing the the cumulative risks of chemicals an additional tenfold (10X) margin of FQPA SF to 3X for infants and children sharing a common mechanism of safety for infants and children in the less than 6 years of age. For the general population, including children greater toxicity. The Agency has determined case of threshold effects to account for than 6 years of age, EPA is reducing the that the pyrethroids and pyrethrins, prenatal and postnatal toxicity and the FQPA SF to 1X. The decisions regarding including fenpropathrin, share a completeness of the database on toxicity the FQPA SFs being used are based on common mechanism of toxicity. The and exposure unless EPA determines the following considerations: members of this group share the ability based on reliable data that a different i. While the database is considered to to interact with voltage-gated sodium margin of safety will be safe for infants be complete with respect to the channels, ultimately leading to and children. This additional margin of guideline toxicity studies for neurotoxicity. The cumulative risk safety is commonly referred to as the fenpropathrin, EPA lacks additional assessment for the pyrethroids/ Food Quality Protection Act Safety data to fully characterize the potential pyrethrins was published in the Federal Factor (FQPA SF). In applying this for juvenile sensitivity to neurotoxic Register of November 9, 2011 (76 FR provision, EPA either retains the default effects of pyrethroids. In light of the 69726) (FRL 8888–9), and is available at value of 10X, or uses a different literature studies indicating a possibility http://www.regulations.gov in docket ID additional SF when reliable data of increased sensitivity in juvenile rats number EPA–HQ–OPP–2011–0746. available to EPA support the choice of at high doses, EPA identified a need, Further information about the a different factor. and requested proposals for, additional determination that pyrethroids and 2. Prenatal and postnatal sensitivity. non-guideline studies to evaluate the pyrethrins share a common mechanism The fenpropathrin toxicity database potential for sensitivity in juvenile rats. of toxicity may be found in document ID includes developmental toxicity studies A group of pyrethroid registrants is number EPA–HQ–OPP–2008–0489– in the rat and rabbit, a 3-generation currently conducting those studies. 0006. reproduction study in the rat, and a Pending the results of those studies, Fenpropathrin was included in the developmental neurotoxicity (DNT) however, the available toxicity studies cumulative risk assessment for study in rats. There was no evidence of for fenpropathrin can be used to pyrethrins and pyrethroids. The increased qualitative or quantitative characterize toxic effects including proposed new uses of fenpropathrin susceptibility noted in any of these potential developmental and will not significantly impact the studies. This lack of susceptibility is reproductive toxicity, immunotoxicity, cumulative assessment because, in the consistent with the results of the and neurotoxicity. Acceptable cumulative assessment, residential guideline pre- and postnatal testing for developmental toxicity studies in rats exposure was the greatest contributor to other pyrethroid pesticides. and rabbits, reproduction studies in rats, the total exposure. As there are no new High-dose LD50 studies (studies neurotoxicity studies (acute, residential uses for the fenpropathrin, assessing what dose results in lethality subchronic, and developmental) in rats, the proposed new uses will have no to 50% of the tested population) in the and immunotoxicity studies in rats are impact on the residential component of scientific literature indicate that available. In addition, a route-specific the cumulative risk estimates. pyrethroids can result in increased dermal toxicity study is available, and quantitative sensitivity in the young, Dietary exposures make a minor the inhalation study has been waived. specifically in the form of neurotoxicity. ii. After reviewing the extensive body contribution to total pyrethroid Examination of pharmacokinetic and of data and peer-reviewed literature on exposure. The dietary exposure pharmacodynamic data indicates that pyrethroids, the Agency has reached a assessment performed in support of the the sensitivity observed at high doses is number of conclusions regarding fetal pyrethroid cumulative was much more related to pyrethroid age-dependent and juvenile sensitivity for pyrethroids, highly refined than that performed for pharmacokinetics—the activity of including the following: the single chemical. The dietary enzymes associated with the • Based on an evaluation of over 70 exposure assessment for the single metabolism of pyrethroids. With guideline toxicity studies for 24 chemical included conservative otherwise equivalent administered pyrethroids submitted to the Agency, assumptions, using field trial data for doses for adults and juveniles, including prenatal developmental many commodities, including the predictive pharmacokinetic models toxicity studies in rats and rabbits, and proposed new uses with the assumption indicate that the differential adult- pre- and postnatal multi-generation of 100 PCT, and the most sensitive juvenile pharmacokinetics will result in reproduction toxicity studies and DNTs apical endpoint in the fenpropathrin a 3X greater dose at the target organ in in rats in support of pyrethroid hazard database was selected to derive juveniles compared to adults. No registrations, there is no evidence that the POD. Additionally, the POD selected evidence of increased quantitative or pyrethroids directly impact developing for fenpropathrin is specific to the qualitative susceptibility was seen in fetuses. None of the studies show any fenpropathrin, whereas the POD the pyrethroid scientific literature indications of fetal toxicity at doses that selected for the cumulative assessment related to pharmacodynamics (the effect do not cause maternal toxicity. was based on common mechanism of of pyrethroids at the target tissue) with • Increased susceptibility was seen in action data that are appropriate for all regard to differences between juveniles offspring animals in the DNT study with 20 pyrethroids included in the and adults. Specifically, there are in the pyrethroid zeta-cypermethrin cumulative assessment. vitro pharmacodynamic data and in vivo (decreased pup body weights) and DNT For information regarding EPA’s data indicating similar responses and reproduction studies with another efforts to evaluate the risk of exposure between adult and juvenile rats at low pyrethroid beta-cyfluthrin (decreased to pyrethroids, refer to http:// doses and data indicating that the rat is body weights and tremors). However, www.epa.gov/oppsrrd1/reevaluation/ a conservative model compared to the the reductions in body weight and the pyrethroids-pyrethrins.html. human based on species-specific other non-specific effects occur at

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higher doses than neurotoxicity, the there is no evidence in the over 70 studies. Second, in vitro data indicate effect of concern for pyrethroids. The guideline toxicity studies submitted to similar pharmacodynamic response to available developmental and the Agency that pyrethroids directly pyrethroids between juvenile and adult reproduction guideline studies in rats impact developing fetuses. rats. Finally, as indicated, with zeta-cypermethrin did not show Additionally, none of the studies show pharmacokinetic modeling only predicts increased sensitivity in the young to any indications of fetal toxicity at doses a 3X difference between juveniles and neurotoxic effects. Overall, findings of that do not cause maternal toxicity. adults. Therefore, the FQPA SF of 3X is increased sensitivity in juvenile animals Because there remains some uncertainty protective of potential juvenile in pyrethroid studies are rare. Therefore, as to juvenile sensitivity due to the sensitivity. the residual concern for the postnatal findings in the high-dose LD50 studies, Further information about the effects is reduced. EPA is retaining a 3X FQPA SF for reevaluation of the FQPA SF for • High-dose LD50 studies (studies infants and children less than 6 years of pyrethroids may be found in document assessing what dose results in lethality age. By age 6, the metabolic system is ID number EPA–HQ–OPP–2011–0746– to 50% of the tested population) in the expected to be at or near adult levels 0011. scientific literature indicate that thus reducing concerns for potential E. Aggregate Risks and Determination of pyrethroids can result in increased age-dependant sensitivity related to Safety quantitative sensitivity to juvenile pharmacokinetics; therefore for children animals. Examination of over 6, 1X is appropriate. Although EPA EPA determines whether acute and pharmacokinetic and pharmacodynamic is seeking additional data to further chronic dietary pesticide exposures are data indicates that the sensitivity characterize the potential neurotoxicity safe by comparing aggregate exposure observed at high doses is related to for pyrethroids, EPA has reliable data estimates to the acute PAD (aPAD) and pyrethroid age-dependent that show that reducing the FQPA SF to chronic PAD (cPAD). For linear cancer pharmacokinetics—the activity of 3X will protect the safety of infants and risks, EPA calculates the lifetime enzymes associated with the children less than 6 years old. These probability of acquiring cancer given the metabolism of pyrethroids. data include: estimated aggregate exposure. Short-, Furthermore, a rat physiologically-based a. Data from developmental, intermediate-, and chronic-term risks pharmacokinetic (PBPK) model predicts reproductive, and DNT guideline are evaluated by comparing the a 3-fold increase of pyrethroid studies with fenpropathrin that show no estimated aggregate food, water, and concentration in juvenile brain sensitivity. residential exposure to the appropriate compared to adults at high doses. b. Data showing that the potential PODs to ensure that an adequate MOE • In vitro pharmacodynamic data and sensitivity at high doses is likely due to exists. in vivo data indicate that adult and pharmacokinetics. 1. Acute risk. Using the exposure juvenile rats have similar responses to c. A rat PBPK model predicting a assumptions discussed in this unit for pyrethroids at low doses and therefore 3-fold increase of pyrethroid acute exposure, the acute dietary juvenile sensitivity is not expected at concentration in juvenile brain exposure from food and water to relevant environmental exposures. compared to adults at high doses due to fenpropathrin will occupy 93% of the Further, data also show that the rat is a age-dependent pharmacokinetics. aPAD for children 1–2 years old, the conservative model compared to the d. Data indicating that the rat is a population group receiving the greatest human based on species-specific conservative model compared to the exposure from the dietary assessment pharmacodynamics of homologous human based on species-specific for infants and children less than 6 sodium channel isoforms. pharmacodynamics of homologous years old; and 20% of the aPAD for iii. There are no residual uncertainties sodium channel isoforms. children 6 to 12 years old, the identified in the exposure databases. For several reasons, EPA concludes population group receiving the greatest Although the acute dietary exposure these data show that a 3X factor is exposure from the dietary assessment estimates are refined, as described in protective of the safety of infants and for the general population other than Unit III.C.1.i., the exposure estimates children less than 6 years of age. First, children less than 6 years old. will not underestimate risk for the it is likely that the extensive guideline 2. Chronic risk. Based on the data established and proposed uses of studies with pyrethroids, which summarized in Unit III.A., there is no fenpropathrin. The residue levels used indicate that increased sensitivity in increase in hazard with increasing dose are based on distributions of residues juvenile animals in pyrethroid studies is duration. Therefore, the acute aggregate from field trial data, monitoring data rare, better characterize the potential assessment is protective of potential reflecting actual residues found in the sensitivity of juvenile animals than the chronic aggregate exposures. food supply, and tolerance-level LD50 studies. The high doses that 3. Short-term risk. Short-term residues for several commodities; the produced juvenile sensitivity in the aggregate exposure takes into account use of estimated PCT information; and, literature studies are well above normal short-term residential exposure plus when appropriate, processing factors dietary or residential exposure levels of chronic exposure to food and water measured in processing studies or pyrethroids to juveniles and lower (considered to be a background default high-end factors representing the levels of exposure anticipated from exposure level). A short-term adverse maximum concentration of residue into dietary and residential uses are not effect was identified; however, a processed commodity. EPA made expected to overwhelm the juvenile’s fenpropathrin is not registered for any conservative (protective) assumptions in ability to metabolize pyrethroids, as use patterns that would result in short- the ground and surface water modeling occurred with the high doses used in term residential exposure. Short-term used to assess exposure to fenpropathrin the literature studies. The fact that a risk is assessed based on short-term in drinking water. These assessments greater sensitivity to the neurotoxicity of residential exposure plus chronic will not underestimate the exposure and pyrethroids is not found in guideline dietary exposure. Because there is no risks posed by fenpropathrin. studies following in utero exposures short-term residential exposure and Taking all of this information into (based on 76 studies for 24 pyrethroids) acute dietary exposure has already been account, EPA has reduced the FQPA SF supports this conclusion, despite the assessed under the appropriately for women of child-bearing age because relatively high doses used in the protective aPAD (which is at least as

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protective as the POD used to assess FFDCA section 408(b)(4) requires that ppm; berry, low-growing, subgroup 13– short-term risk), no further assessment EPA explain the reasons for departing 07G at 2.0 ppm; bushberry subgroup 13– of short-term risk is necessary, and EPA from the Codex level. 07B at 3.0 ppm; fruit, citrus, group 10– relies on the acute dietary risk Codex has established MRLs for 10 at 2.0 ppm; fruit, pome, group 11–10 assessment for evaluating short-term tomatoes, sweet peppers, dried chili at 5.0 ppm; fruit, small vine climbing, risk for fenpropathrin. peppers, eggplant, grapes, and pome except fuzzy kiwifruit, subgroup 13–07F 4. Intermediate-term risk. fruits. The MRLs for tomatoes, sweet at 5.0 ppm; and vegetable, fruiting, Intermediate-term aggregate exposure peppers, grapes, and pome fruits are group 8–10 at 1.0 ppm. Additionally, takes into account intermediate-term harmonized with the U.S. tolerances for this document removes the established residential exposure plus chronic the corresponding crop groups or tolerances of fenpropathrin in or on exposure to food and water (considered subgroups. Codex MRLs for dried chili fruit, citrus, group 10; fruit, pome, group to be a background exposure level). peppers (10 ppm) and eggplant (0.2 11; bushberry subgroup 13B; grape; Because no intermediate-term adverse ppm) cannot be harmonized with the juneberry; lingonberry; salal; strawberry; effect was identified, fenpropathrin is U.S. tolerance for the fruiting vegetable and vegetable, fruiting, group 8. not expected to pose an intermediate- crop group (1.0 ppm), of which those commodities are a part. The Codex MRL VI. Statutory and Executive Order term risk. Reviews 5. Aggregate cancer risk for U.S. for eggplant is lower than the population. Based on the lack of recommended corresponding U.S. This final rule establishes tolerances evidence of carcinogenicity in two tolerance. Because the permitted under FFDCA section 408(d) in adequate rodent carcinogenicity studies, domestic use on eggplant in accordance response to a petition submitted to the fenpropathrin is not expected to pose a with the approved pesticide label Agency. The Office of Management and cancer risk to humans. results in residue levels higher than the Budget (OMB) has exempted these types 6. Determination of safety. Based on Codex MRLs, the U.S. tolerance cannot of actions from review under Executive these risk assessments, EPA concludes be harmonized (lowered) since doing so Order 12866, entitled ‘‘Regulatory that there is a reasonable certainty that would result in residues in excess of the Planning and Review’’ (58 FR 51735, no harm will result to the general approved tolerance in spite of use October 4, 1993). Because this final rule population or to infants and children consistent with label directions. has been exempted from review under from aggregate exposure to Concerning dried chili peppers, EPA, Executive Order 12866, this final rule is fenpropathrin residues. under its Residue Chemistry Test not subject to Executive Order 13211, Guidelines (OPPTS 860.1000), does not entitled ‘‘Actions Concerning IV. Other Considerations set tolerances for dried chili peppers. Regulations That Significantly Affect A. Analytical Enforcement Methodology Rather, residues on dried chili peppers Energy Supply, Distribution, or Use’’ would be covered under tolerances for (66 FR 28355, May 22, 2001) or Adequate enforcement methodology non-bell peppers, which, for this Executive Order 13045, entitled utilizing gas chromatography with chemical, are captured by the fruiting ‘‘Protection of Children From electron capture detector (GC/ECD), vegetable crop group tolerance. Under Environmental Health Risks and Safety Residue Method Numbers RM–22–4 that U.S. tolerance, residues of Risks’’ (62 FR 19885, April 23, 1997). (plants) and RM–22A–1 (animals), is fenpropathrin on dried chili peppers This final rule does not contain any available to enforce the tolerance would be covered up to 1.0 ppm; information collections subject to OMB expression. residues in excess of that level would approval under the Paperwork The method may be requested from: only be covered if EPA established a Reduction Act (PRA) (44 U.S.C. 3501 et Chief, Analytical Chemistry Branch, separate tolerance for them. At this seq.), nor does it require any special Environmental Science Center, 701 time, however, EPA does not have data considerations under Executive Order Mapes Rd., Ft. Meade, MD 20755–5350; to support establishing a tolerance for 12898, entitled ‘‘Federal Actions To telephone number: (410) 305–2905; dried chili peppers at 10 ppm. Address Environmental Justice in email address: residuemethods@ Minority Populations and Low-Income epa.gov. C. Revisions to Petitioned-For Populations’’ (59 FR 7629, February 16, Tolerances 1994). B. International Residue Limits Based on the data submitted with the Since tolerances and exemptions that In making its tolerance decisions, EPA petition, EPA is also removing the are established on the basis of a petition seeks to harmonize U.S. tolerances with established tolerance for lingonberry. under FFDCA section 408(d), such as international standards whenever The Agency is removing this tolerance the tolerances in this final rule, do not possible, consistent with U.S. food because it will be superseded by the require the issuance of a proposed rule, safety standards and agricultural new tolerance for bushberry subgroup the requirements of the Regulatory practices. EPA considers the 13–07B, established by this document. Flexibility Act (RFA) (5 U.S.C. 601 et international maximum residue limits The removal does not substantively seq.), do not apply. (MRLs) established by the Codex affect whether residues of fenpropathrin This final rule directly regulates Alimentarius Commission (Codex), as may be present on lingonberry. The new growers, food processors, food handlers, required by FFDCA section 408(b)(4). bushberry subgroup 13–07B tolerance is and food retailers, not States or tribes, The Codex Alimentarius is a joint at the same level as the lingonberry nor does this action alter the United Nations Food and Agriculture tolerance being removed—3.0 ppm. relationships or distribution of power Organization/World Health and responsibilities established by Organization food standards program, V. Conclusion Congress in the preemption provisions and it is recognized as an international Therefore, tolerances are established of FFDCA section 408(n)(4). As such, food safety standards-setting for residues of fenpropathrin, alpha- the Agency has determined that this organization in trade agreements to cyano-3-phenoxybenzyl 2,2,3,3- action will not have a substantial direct which the United States is a party. EPA tetramethylcyclopropanecarboxylate, in effect on States or tribal governments, may establish a tolerance that is or on barley, grain at 0.04 ppm; barley, on the relationship between the national different from a Codex MRL; however, hay at 3.0 ppm; barley, straw at 2.0 government and the States or tribal

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governments, or on the distribution of § 180.466 Fenpropathrin; tolerances for southwest/es/NewMexico/index.cfm and power and responsibilities among the residues. at http://www.regulations.gov at Docket various levels of government or between (a) * * * No. FWS–R2–ES–2013–0005. Comments the Federal Government and Indian and materials we received, as well as Tribes. Thus, the Agency has Commodity Parts per supporting documentation used in determined that Executive Order 13132, million preparing this final rule, are available entitled ‘‘Federalism’’ (64 FR 43255, for public inspection, by appointment, August 10, 1999) and Executive Order ***** during normal business hours, at the 13175, entitled ‘‘Consultation and Barley, grain ...... 0.04 U.S. Fish and Wildlife Service, New Coordination With Indian Tribal Barley, hay ...... 3 .0 Mexico Ecological Services Field Office, Governments’’ (65 FR 67249, November Barley, straw ...... 2 .0 2105 Osuna NE., Albuquerque, NM 9, 2000) do not apply to this final rule. Berry, low growing, subgroup 87113; telephone 505–346–2525; or In addition, this final rule does not 13–07G ...... 2 .0 facsimile 505–346–2542. impose any enforceable duty or contain The coordinates or plot points or both ***** from which the maps are generated are any unfunded mandate as described Bushberry subgroup 13–07B .. 3 .0 under Title II of the Unfunded Mandates included in the administrative record Reform Act of 1995 (UMRA) (2 U.S.C. ***** for this critical habitat designation and 1501 et seq.). Fruit, citrus, group 10–10 ...... 2.0 are available at http://www.fws.gov/ This action does not involve any Fruit, pome, group 11–10 ...... 5.0 southwest/es/NewMexico/index.cfm, at technical standards that would require Fruit, small vine climbing, ex- http://www.regulations.gov at Docket Agency consideration of voluntary cept fuzzy kiwifruit, sub- No. FWS–R2–ES–2013–0005, and at the consensus standards pursuant to section group 13–07F ...... 5.0 New Mexico Ecological Services Field Office (see FOR FURTHER INFORMATION 12(d) of the National Technology ***** CONTACT). Any additional tools or Transfer and Advancement Act of 1995 Vegetable, fruiting, group 8– (NTTAA) (15 U.S.C. 272 note). 10 ...... 1.0 supporting information that we developed for this critical habitat VII. Congressional Review Act ***** designation are also available at the Fish Pursuant to the Congressional Review and Wildlife Service Web site and Field Act (5 U.S.C. 801 et seq.), EPA will * * * * * Office set out above, and may also be submit a report containing this rule and [FR Doc. 2013–27680 Filed 11–19–13; 8:45 am] included in the preamble of this rule or other required information to the U.S. BILLING CODE 6560–50–P at http://www.regulations.gov. Senate, the U.S. House of FOR FURTHER INFORMATION CONTACT: Representatives, and the Comptroller Wally Murphy, Field Supervisor, U.S. General of the United States prior to DEPARTMENT OF THE INTERIOR Fish and Wildlife Service, New Mexico publication of the rule in the Federal Ecological Services Field Office, 2105 Register. This action is not a ‘‘major Fish and Wildlife Service Osuna NE., Albuquerque, NM 87113; by rule’’ as defined by 5 U.S.C. 804(2). telephone 505–346–2525; or by 50 CFR Part 17 facsimile 505–346–2542. If you use a List of Subjects in 40 CFR Part 180 [Docket No. FWS–R2–ES–2013–0005: telecommunications device for the deaf Environmental protection, 4500030113] (TDD), call the Federal Information Administrative practice and procedure, Relay Service (FIRS) at 800–877–8339. RIN 1018–AZ28 Agricultural commodities, Pesticides SUPPLEMENTARY INFORMATION: and pests, Reporting and recordkeeping Endangered and Threatened Wildlife Executive Summary requirements. and Plants; Designation of Critical Dated: November 7, 2013. Habitat for the Jemez Mountains Why we need to publish a rule. Under the Endangered Species Act (Act), any Daniel J. Rosenblatt, Salamander species that is determined to be an Acting Director, Registration Division, Office AGENCY: Fish and Wildlife Service, endangered or threatened species of Pesticide Programs. Interior. requires critical habitat to be designated, Therefore, 40 CFR chapter I is ACTION: Final rule. to the maximum extent prudent and amended as follows: determinable. Designations and SUMMARY: We, the U.S. Fish and revisions of critical habitat can only be PART 180—[AMENDED] Wildlife Service, designate critical completed by issuing a rule. habitat for the Jemez Mountains We listed the Jemez Mountains ■ 1. The authority citation for part 180 salamander (Plethodon neomexicanus) salamander as an endangered species on continues to read as follows: under the Endangered Species Act of September 10, 2013 (78 FR 55599). This Authority: 21 U.S.C. 321(q), 346a and 371. 1973 (Act), as amended. In total, we are is a final rule to designate critical designating as critical habitat for this habitat for the Jemez Mountains ■ 2. In § 180.466: species approximately 90,716 acres salamander. Section 4(b)(2) of the Act ■ a. Remove the entries for ‘‘Bushberry (36,711 hectares) in Los Alamos, Rio states that the Secretary shall designate subgroup 13B,’’ ‘‘Fruit, citrus, group Arriba, and Sandoval Counties, New critical habitat on the basis of the best 10,’’ ‘‘Fruit, pome, group 11,’’ ‘‘Grape,’’ Mexico. The effect of this regulation is available scientific data after taking into ‘‘Juneberry,’’ ‘‘Lingonberry,’’ ‘‘Salal,’’ to conserve the Jemez Mountains consideration the economic impact, ‘‘Strawberry,’’ and ‘‘Vegetable, fruiting, salamander’s habitat under the Act. national security impact, and any other group 8’’ from the table in paragraph (a). DATES: This rule is effective on relevant impact of specifying any ■ b. Add alphabetically the following December 20, 2013. particular area as critical habitat. entries to the table in paragraph (a). ADDRESSES: This final rule is available The critical habitat areas we are The amendments read as follows: on the Internet at http://www.fws.gov/ designating in this rule constitute our

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