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and responsibilities established by § 180.132 Thiram; tolerances for residues. Reading Room is (202) 566–1744, and Congress in the preemption provisions (a) General. Tolerances for residues of the telephone number for the OPP of FFDCA section 408(n)(4). As such, the fungicide thiram (tetramethyl Docket is (703) 305–5805. Please review the Agency has determined that this thiuram disulfide), including its the visitor instructions and additional action will not have a substantial direct metabolites and degradates, in or on the information about the docket available effect on States or tribal governments, commodities in the table below. at http://www.epa.gov/dockets. on the relationship between the national Compliance with the tolerance levels FOR FURTHER INFORMATION CONTACT: Lois government and the States or tribal specified is to be determined by Rossi, Registration Division (7505P), governments, or on the distribution of measuring only thiram. Office of Pesticide Programs, power and responsibilities among the Environmental Protection Agency, 1200 various levels of government or between Parts per Expiration/ Pennsylvania Ave. NW., Washington, the Federal Government and Indian Commodity revocation million date DC 20460–0001; telephone number: tribes. Thus, the Agency has determined (703) 305–7090; email address: that Executive Order 13132, entitled [email protected]. ‘‘Federalism’’ (64 FR 43255, August 10, ***** SUPPLEMENTARY INFORMATION: 1999) and Executive Order 13175, Strawberry ...... 20 None. entitled ‘‘Consultation and Coordination I. General Information with Indian Tribal Governments’’ (65 FR * * * * * A. Does this action apply to me? 67249, November 9, 2000) do not apply [FR Doc. 2014–03074 Filed 2–11–14; 8:45 am] You may be potentially affected by to this final rule. In addition, this final BILLING CODE 6560–50–P rule does not impose any enforceable this action if you are an agricultural duty or contain any unfunded mandate producer, food manufacturer, or as described under Title II of the ENVIRONMENTAL PROTECTION pesticide manufacturer. The following Unfunded Mandates Reform Act of 1995 AGENCY list of North American Industrial (UMRA) (2 U.S.C. 1501 et seq.). Classification System (NAICS) codes is This action does not involve any 40 CFR Part 180 not intended to be exhaustive, but rather provides a guide to help readers technical standards that would require [EPA–HQ–OPP–2012–0791; FRL–9905–22] Agency consideration of voluntary determine whether this document consensus standards pursuant to section Linuron; Pesticide Tolerances applies to them. Potentially affected 12(d) of the National Technology entities may include: AGENCY: Environmental Protection • Crop production (NAICS code 111). Transfer and Advancement Act of 1995 Agency (EPA). • Animal production (NAICS code (NTTAA) (15 U.S.C. 272 note). ACTION: Final rule. 112). VII. Congressional Review Act • Food manufacturing (NAICS code SUMMARY: This regulation establishes 311). Pursuant to the Congressional Review tolerances for residues of linuron in or • Pesticide manufacturing (NAICS Act (5 U.S.C. 801 et seq.), EPA will on multiple commodities which are code 32532). submit a report containing this rule and identified and discussed later in this other required information to the U.S. document. This regulation additionally B. How can I get electronic access to Senate, the U.S. House of removes a tolerance with regional other related information? Representatives, and the Comptroller registrations in or on parsley leaves, as You may access a frequently updated General of the United States prior to it will be superseded by a tolerance electronic version of EPA’s tolerance publication of the rule in the Federal without regional registrations. IR–4 regulations at 40 CFR part 180 through Register. This action is not a ‘‘major requested these tolerances under the the Government Printing Office’s e-CFR rule’’ as defined by 5 U.S.C. 804(2). Federal Food, Drug, and Cosmetic Act site at http://www.ecfr.gov/cgi-bin/text- List of Subjects in 40 CFR Part 180 (FFDCA). idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 40tab_02.tpl. Environmental protection, DATES: This regulation is effective Administrative practice and procedure, February 12, 2014. Objections and C. How can I file an objection or hearing Agricultural commodities, Pesticides requests for hearings must be received request? and pests, Reporting and recordkeeping on or before April 14, 2014, and must Under FFDCA section 408(g), 21 requirements. be filed in accordance with instructions U.S.C. 346a, any person may file an provided in 40 CFR part 178 (see also objection to any aspect of this regulation Dated: January 27, 2014. SUPPLEMENTARY Unit I.C. of the and may also request a hearing on those Lois Rossi, INFORMATION). Director, Registration Division, Office of objections. You must file your objection Pesticide Programs. ADDRESSES: The docket for this action, or request a hearing on this regulation identified by docket identification (ID) in accordance with the instructions Therefore, 40 CFR chapter I is number EPA–HQ–OPP–2012–0791, is provided in 40 CFR part 178. To ensure amended as follows: available at http://www.regulations.gov proper receipt by EPA, you must PART 180—[AMENDED] or at the Office of Pesticide Programs identify docket ID number EPA–HQ– Regulatory Public Docket (OPP Docket) OPP–2012–0791 in the subject line on ■ 1. The authority citation for part 180 in the Environmental Protection Agency the first page of your submission. All continues to read as follows: Docket Center (EPA/DC), EPA West objections and requests for a hearing Bldg., Rm. 3334, 1301 Constitution Ave. must be in writing, and must be Authority: 21 U.S.C. 321(q), 346a and 371. NW., Washington, DC 20460–0001. The received by the Hearing Clerk on or ■ 2. In § 180.132, revise the introductory Public Reading Room is open from 8:30 before April 14, 2014. Addresses for text of paragraph (a) and revise the entry a.m. to 4:30 p.m., Monday through mail and hand delivery of objections for ‘‘Strawberry’’ in the table in Friday, excluding legal holidays. The and hearing requests are provided in 40 paragraph (a) to read as follows: telephone number for the Public CFR 178.25(b).

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In addition to filing an objection or were received on the notice of filing. and other relevant information in hearing request with the Hearing Clerk EPA’s response to these comments is support of this action. EPA has as described in 40 CFR part 178, please discussed in Unit IV.C. sufficient data to assess the hazards of submit a copy of the filing (excluding Subsequent to the publication of the and to make a determination on any Confidential Business Information November 7, 2012 Federal Register aggregate exposure for linuron including (CBI)) for inclusion in the public docket. notice, the petitioner submitted a exposure resulting from the tolerances Information not marked confidential second petition, in which it requested established by this action. EPA’s pursuant to 40 CFR part 2 may be again the same tolerances noticed in the assessment of exposures and risks disclosed publicly by EPA without prior November 7, 2012 Federal Register associated with linuron follows. notice. Submit the non-CBI copy of your document and added a new request for A. Toxicological Profile objection or hearing request, identified a tolerance for residues of linuron and by docket ID number EPA–HQ–OPP– its metabolites in or on coriander seed EPA has evaluated the available 2012–0791, by one of the following at 0.01 ppm. So, in the Federal Register toxicity data and considered its validity, methods: of July 19, 2013 (78 FR 43115) (FRL– completeness, and reliability as well as • Federal eRulemaking Portal: http:// 9392–9), EPA issued another document the relationship of the results of the www.regulations.gov. Follow the online pursuant to FFDCA section 408(d)(3), 21 studies to human risk. EPA has also instructions for submitting comments. U.S.C. 346a(d)(3), announcing the filing considered available information Do not submit electronically any of a pesticide petition (PP 2E8083) by concerning the variability of the information you consider to be CBI or IR–4, seeking tolerances for sensitivities of major identifiable other information whose disclosure is commodities as noted in the November subgroups of consumers, including restricted by statute. 7, 2012 document as well as a tolerance infants and children. • Mail: OPP Docket, Environmental for coriander seed at 0.01 ppm. That With repeated dosing in test animals, Protection Agency Docket Center (EPA/ document referenced a summary of the linuron produces two primary effects: DC), (28221T), 1200 Pennsylvania Ave. petition prepared on behalf of IR–4 by (1) Changes in the hematopoetic system NW., Washington, DC 20460–0001. Syngenta Crop Protection, LLC, the in rats, mice, and dogs and; (2) changes • Hand Delivery: To make special registrant, which is available in the in the male reproductive system in arrangements for hand delivery or docket, http://www.regulations.gov. developing rats. Lowest observed delivery of boxed information, please There were no comments received in adverse effect levels (LOAELs) for follow the instructions at http:// response to the notice of filing. hematological effects produced by www.epa.gov/dockets/contacts.htm. Based upon review of the data linuron were substantially lower than Additional instructions on commenting supporting the petition, EPA has revised LOAELs for reproductive effects. Dogs or visiting the docket, along with more the tolerances for several proposed were shown to be most sensitive to the information about dockets generally, is commodities. The Agency has also hematological effects, including available at http://www.epa.gov/ determined that the tolerance hemolytic anemia characterized by dockets. expression should be revised for all slightly reduced hemoglobin, commodities. The reasons for these hematocrit, and erythrocyte counts II. Summary of Petitioned-for Tolerance changes are explained in Unit IV.D. accompanied by hemosiderin In the Federal Register of November deposition in liver Kupffer cells. 7, 2012 (77 FR 66781) (FRL–9367–5), III. Aggregate Risk Assessment and Secondary erythropogenic activity EPA issued a document pursuant to Determination of Safety (erythroid hyperplasia of bone marrow) FFDCA section 408(d)(3), 21 U.S.C. Section 408(b)(2)(A)(i) of FFDCA was also found. Systemic toxicity 346a(d)(3), announcing the filing of a allows EPA to establish a tolerance (the observed in mice included increased pesticide petition (PP 2E8083) by IR–4, legal limit for a pesticide chemical methemoglobin formation, vacuolation 500 College Road East, Suite 201 W., residue in or on a food) only if EPA and hemosiderosis of the spleen, and Princeton, NJ 08540. The petition determines that the tolerance is ‘‘safe.’’ decreased erythrocyte counts. In the requested that 40 CFR 180.184 be Section 408(b)(2)(A)(ii) of FFDCA chronic rat study, microscopic amended by establishing tolerances for defines ‘‘safe’’ to mean that ‘‘there is a observations consistent with hemolysis residues of the herbicide linuron, 3-(3,4- reasonable certainty that no harm will (hemosiderin in Kupffer cells and dichlorophenyl)-1-methoxy-1- result from aggregate exposure to the increased hemosiderosis in bone methylurea), and its metabolites, in or pesticide chemical residue, including marrow, spleen, and/or mesenteric on cilantro, dried leaves at 27 parts per all anticipated dietary exposures and all lymph nodes) were found. million (ppm); cilantro, fresh leaves at other exposures for which there is The rat developmental study showed 3 ppm; dillweed, dried leaves at 7.1 reliable information.’’ This includes increased post-implantation loss, fetal ppm; dillweed, fresh leaves at 1.5 ppm; exposure through drinking water and in resorptions, decreased litter size, and dill oil at 4.8 ppm; dill seed at 0.3 ppm; residential settings, but does not include decreased fetal body weight. In the horseradish at 0.050 ppm; parsley, dried occupational exposure. Section rabbit developmental toxicity study, an leaves at 8.3 ppm; parsley leaves at 3 408(b)(2)(C) of FFDCA requires EPA to increased incidence of fetuses with ppm; and pea, dry, seed at 0.08 ppm. give special consideration to exposure skeletal skull variations was found. In The petition additionally requested to of infants and children to the pesticide the 2-generation reproductive toxicity delete the regional tolerance in 40 CFR chemical residue in establishing a study, rats exposed to linuron during 180.184(c) for residues of linuron in or tolerance and to ‘‘ensure that there is a both development and adulthood had on parsley, leaves at 0.25 ppm upon reasonable certainty that no harm will gross lesions of the testes (including approval of the requested tolerances for result to infants and children from reduction in size); abnormally soft and parsley leaves. That document aggregate exposure to the pesticide small epididymides, deformities of the referenced a summary of the petition chemical residue. . . .’’ epididymides, decreased pup survival, prepared on behalf of IR–4 by Syngenta Consistent with FFDCA section decreased weanling body weights, Crop Protection, LLC, the registrant, 408(b)(2)(D), and the factors specified in decreased liver and kidney weights; and which is available in the docket, FFDCA section 408(b)(2)(D), EPA has increased incidence of offspring liver http://www.regulations.gov. Comments reviewed the available scientific data atrophy.

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The developmental effects on the necessary because both interstitial cell Celeriac, Rhubarb, and Pea (Dry).’’ at reproductive system seen in the adenomas and hepatocellular adenomas pages 33–38 in docket ID number EPA– guideline studies are consistent with were benign and show no progression HQ–OPP–2012–0791. References for the those reported in the published towards malignancy. In addition, published toxicity studies cited in this literature, though it should be noted that linuron was not mutagenic in bacteria or section may be found Unit VI. most of the literature studies employed in cultured mammalian cells. There was dose levels of 100 milligrams/kilogram also no indication of a clastogenic effect B. Toxicological Points of Departure/ (mg/kg) or greater. The available data up to toxic doses in vivo. Finally, the Levels of Concern indicate that linuron inhibits cRFD is a NOAEL of 0.77 mg/kg/day, Once a pesticide’s toxicological transcriptional activity of which would be protective of any profile is determined, EPA identifies tumors caused by linuron in the rat and dihydrotestosterone (DHT), human toxicological points of departure (POD) mouse carcinogenicity study at higher androgen receptor (hAR) in vitro, and and levels of concern to use in steroidogenic enzymes. Additional doses. At the highest dose tested, the acute evaluating the risk posed by human findings indicate that linuron exposure exposure to the pesticide. For hazards decreases anogenital distance; may neurotoxicity study demonstrated that linuron produced changes in the that have a threshold below which there increase retention of areole/nipples in is no appreciable risk, the toxicological male rat offspring following in utero parameters of the field observation battery (FOB). These changes included POD is used as the basis for derivation exposure; increases luteinizing hormone of reference values for risk assessment. (LH) levels in F0 and F1 male rats; rats holding their heads low, crusty deposits on the nose, impaired mobility, PODs are developed based on a careful reduces the size of androgen dependent analysis of the doses in each tissues such as seminal vesicles, ataxia, low arousal, decreased rearing, no reaction to tail pinch or startle, toxicological study to determine the epididymis, and ventral prostate; and dose at which no adverse effects are demonstrates a weak affinity for decreased righting reflex, reduced or no hindlimb extensor strength, decreased observed (the NOAEL) and the lowest androgen receptors, which may decrease dose at which adverse effects of concern fetal testosterone synthesis (Refs 1, 2, 3, grip strength in both hindlimbs and forelimbs, reduced rotarod performance, are identified (the LOAEL). Uncertainty/ and 4). At this time, linuron has not safety factors are used in conjunction been demonstrated to be an estrogen decreased hindlimb footsplay, and increased catalepsy. At the lowest- with the POD to calculate a safe receptor antagonist (Ref 5). It should be observed-adverse-effect-level (LOAEL), exposure level—generally referred to as emphasized that the toxicity endpoints linuron produced decreases in motor a population-adjusted dose (PAD) or a based on the hematological effects for activity and rearing. No compound- reference dose (RfD)—and a safe margin chronic exposures were derived from related changes in neurohistopathology of exposure (MOE). For non-threshold the chronic oral toxicity study in dogs. were observed at any of the tested dose risks, the Agency assumes that any The point of departure (POD) for levels. In addition, linuron did not show amount of exposure will lead to some hematological effects was approximately any signs of immunotoxicity in the degree of risk. Thus, the Agency 40X lower than the LOAEL that caused submitted immunotoxicity study up to estimates risk in terms of the probability the testicular effects seen in the rat the highest dose tested. of an occurrence of the adverse effect reproduction toxicity study. Specific information on the studies expected in a lifetime. For more In rat and mouse carcinogenicity received and the nature of the adverse information on the general principles studies, linuron induced interstitial cell effects caused by linuron as well as the EPA uses in risk characterization and a adenomas in the testes of rats and no-observed-adverse-effect-level complete description of the risk hepatocellular adenomas in mice. In a (NOAEL) and the LOAEL from the assessment process, see http:// special study with aged rats, linuron toxicity studies can be found at http:// www.epa.gov/pesticides/factsheets/ induced hyperplasia and adenomas of www.regulations.gov in document: riskassess.htm. A summary of the the testes within 6 to 12 months. ‘‘Linuron: Section 3 Human Health Risk toxicological endpoints for linuron used However, EPA has concluded that Assessment for Proposed Use on for human risk assessment is shown in quantification of cancer risk is not Coriander, Dill, Horseradish, Parsley, Table 1 of this unit.

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR LINURON FOR USE IN HUMAN HEALTH RISK ASSESSMENT

Point of departure Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects safety factors risk assessment

Acute dietary (Females 13–49 years of NOAEL = 12 mg/ Acute RfD = 0.12 Rat Developmental Toxicity. age). kg/day mg/kg/day LOAEL = 50 mg/kg/day based on increased post-implan- UFA = 10X aPAD = 0.12 mg/ tation loss and fetal/litter resorptions. UFH = 10X kg/day FQPA SF = 1X Acute dietary (General population in- NOAEL = 20 mg/ Acute RfD = 0.2 Acute Neurotoxicity Study (Rat). cluding infants and children). kg/day. mg/kg/day. LOAEL = 100 mg/kg based on decreases in rearing and in UFA = 10X aPAD = 0.2 mg/kg/ motor activity. UFH = 10X day FQPA SF = 1X Chronic dietary (All populations) ...... NOAEL= 0.77 mg/ Chronic RfD = Chronic Oral Dog Study. kg/day. 0.0077 mg/kg/ LOAEL = 3.5 mg/kg/day based on hematological effects UFA = 10X day. (increased met- and sulf-hemoglobin levels). UFH = 10X cPAD = 0.0077 FQPA SF = 1X mg/kg/day

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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR LINURON FOR USE IN HUMAN HEALTH RISK ASSESSMENT—Continued

Point of departure Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects safety factors risk assessment

Cancer (Oral, dermal, inhalation) ...... Quantification of human cancer risk is not necessary for reasons stated in Unit III.A. FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = milligrams/kilogram/day. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies).

C. Exposure Assessment show what percentage of the food Condition a, PCT estimates are derived 1. Dietary exposure from food and derived from such crop is likely to from Federal and private market survey contain the pesticide residue. data, which are reliable and have a valid feed uses. In evaluating dietary • exposure to linuron, EPA considered Condition b: The exposure estimate basis. The Agency is reasonably certain exposure under the petitioned-for does not underestimate exposure for any that the percentage of the food treated significant subpopulation group. is not likely to be an underestimation. tolerances as well as all existing linuron • tolerances in 40 CFR 180.184. EPA Condition c: Data are available on As to Conditions b and c, regional assessed dietary exposures from linuron pesticide use and food consumption in consumption information and in food as follows: a particular area, the exposure estimate consumption information for significant i. Acute exposure. Quantitative acute does not understate exposure for the subpopulations is taken into account dietary exposure and risk assessments population in such area. through EPA’s computer-based model are performed for a food-use pesticide, In addition, the Agency must provide for evaluating the exposure of if a toxicological study has indicated the for periodic evaluation of any estimates significant subpopulations including possibility of an effect of concern used. To provide for the periodic several regional groups. Use of this occurring as a result of a 1-day or single evaluation of the estimate of PCT as consumption information in EPA’s risk exposure. Such effects were identified required by FFDCA section 408(b)(2)(F), assessment process ensures that EPA’s for linuron. In estimating acute dietary EPA may require registrants to submit exposure estimate does not understate exposure, EPA used Dietary Exposure data on PCT. exposure for any significant Evaluation Model software with the The Agency estimated the average subpopulation group and allows the Food Commodity Intake Database PCT for existing uses for use in the Agency to be reasonably certain that no (DEEM–FCID) Version 3.16, which uses chronic dietary assessment as follows: regional population is exposed to food consumption data from the U.S. Asparagus, 25%; carrots, 85%; celery, residue levels higher than those Department of Agriculture’s (USDA’s) 25%; corn, 1.0%; cotton, 1.0%; estimated by the Agency. Other than the National Health and Nutrition potatoes, 5.0%; sorghum, 1.0%; data available through national food Examination Survey, ‘‘What We Eat in soybeans, 1.0%; sweet corn, 1.0%; and consumption surveys, EPA does not America’’ (NHANES/WWEIA) from wheat, 1.0%. have available reliable information on 2003 through 2008. As to residue levels In most cases, EPA uses available data the regional consumption of food to in food, EPA utilized tolerance-level from United States Department of which linuron may be applied in a residues, DEEM (Ver. 7.81) default Agriculture/National Agricultural particular area. processing factors as necessary, and 100 Statistics Service (USDA/NASS), 2. Dietary exposure from drinking proprietary market surveys, and the percent crop treated (PCT) for all water. The Agency used screening level National Pesticide Use Database for the commodities. water exposure models in the dietary chemical/crop combination for the most ii. Chronic exposure. In conducting exposure analysis and risk assessment recent 6–7 years. EPA uses an average the chronic dietary exposure for linuron in drinking water. These PCT for chronic dietary risk analysis. assessment. EPA used the food simulation models take into account The average PCT figure for each existing consumption data from the USDA’s data on the physical, chemical, and fate/ use is derived by combining available 2003–2008 NHANES/WWEIA. As to transport characteristics of linuron. public and private market survey data residue levels in food, EPA used Further information regarding EPA for that use, averaging across all tolerance-level residues for all drinking water models used in pesticide observations, and rounding to the commodities, and DEEM default exposure assessment can be found at processing factors. The Agency utilized nearest 5%, except for those situations in which the average PCT is less than http://www.epa.gov/oppefed1/models/ average PCT estimates, when available, water/index.htm. and 100 PCT for all other commodities. one. In those cases, 1% is used as the iii. Cancer. Based on the data average PCT and 2.5% is used as the Based on the Pesticide Root Zone summarized in Unit III.A., EPA has maximum PCT. EPA uses a maximum Model/Exposure Analysis Modeling concluded that a cancer exposure PCT for acute dietary risk analysis. The System (PRZM/EXAMS) and Pesticide assessment is not necessary. maximum PCT figure is the highest Root Zone Model Ground Water (PRZM iv. Anticipated residue and PCT observed maximum value reported GW), the estimated drinking water information. Section 408(b)(2)(F) of within the recent 6 years of available concentrations (EDWCs) of linuron for FFDCA states that the Agency may use public and private market survey data surface water are estimated to be 89.05 data on the actual percent of food for the existing use and rounded up to parts per billion (ppb) for acute treated for assessing chronic dietary risk the nearest multiple of 5%. exposures and 48.69 ppb for chronic only if: The Agency believes that the three exposures for non-cancer assessments. • Condition a: The data used are conditions discussed in Unit III.C.1.iv. The EDWCs of linuron for groundwater reliable and provide a valid basis to have been met. With respect to are estimated to be 48.8 ppb for acute

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and chronic exposures for non-cancer data available to EPA support the choice greater than most PODs selected for risk assessments. of a different factor. assessment. The nervous system was not Modeled estimates of drinking water 2. Prenatal and postnatal sensitivity. a target organ for linuron. The concentrations were directly entered The following acceptable studies are requirement of a subchronic into the dietary exposure model. For available to assess the prenatal and neurotoxicity study was waived by the acute dietary risk assessment, the water postnatal sensitivity to linuron: rat and Agency because the target systems for concentration value of 89.05 ppb was rabbit developmental toxicity studies, a linuron toxicity are the hematopoietic used to assess the contribution to 2-generation rat reproductive toxicity and endocrine systems and not the drinking water. For chronic dietary risk study, and a 3-generation rat nervous system as shown by all assessment, the water concentration of reproductive toxicity study. There is no available/required toxicity studies. value 48.8 ppb was used to assess the qualitative or quantitative evidence of There is no need for a developmental contribution to drinking water. increased susceptibility of rabbits in the neurotoxicity study because linuron 3. From non-dietary exposure. The developmental study; developmental affects testes and hematological term ‘‘residential exposure’’ is used in effects were seen at a dose higher than parameters but did not produce an this document to refer to non- those causing maternal toxicity. In the increased susceptibility in young rats. occupational, non-dietary exposure rat developmental study, increases in Therefore, the concern for neurotoxicity (e.g., for lawn and garden pest control, post-implantation losses and increases is low, and there is no need for a indoor pest control, termiticides, and in fetal resorptions/litter were seen at a developmental neurotoxicity study or flea and tick control on pets). Linuron dose that caused decreases in maternal additional UFs to account for is not registered for any specific use body weight and food consumption. neurotoxicity. patterns that would result in residential Since increases in resorptions were iii. There is no evidence that linuron exposure. marginal and there was no change in the results in increased susceptibility in in number of live fetuses to corroborate the utero rats or rabbits in the prenatal 4. Cumulative effects from substances increases in post-implantation losses, developmental studies. While increased with a common mechanism of toxicity. these effects were not indicative of qualitative susceptibility was identified Section 408(b)(2)(D)(v) of FFDCA qualitative evidence of susceptibility. from the reproductive findings in the 2- requires that, when considering whether There was no quantitative evidence of generation and 3-generation rat toxicity to establish, modify, or revoke a susceptibility in either the 2-generation studies, clear NOAELs were established tolerance, the Agency consider or the 3-generation reproduction for the effects on the reproductive ‘‘available information’’ concerning the studies. In the 2-generation study, system. Furthermore, the point of cumulative effects of a particular reduced body weight gains of pups were departure (POD) selected for assessment pesticide’s residues and ‘‘other seen at the same dose that caused of chronic effects, is approximately 40X substances that have a common decreases in parental body weights. In lower than the LOAEL that caused the mechanism of toxicity.’’ EPA has not the 3-generation study, offspring effects testicular effects seen in the rat found linuron to share a common including deceased pup survival and reproduction toxicity study; therefore, mechanism of toxicity with any other pup body weight were seen a dose (44 EPA considers the PODs for risk substances, and linuron does not appear mg/kg/day) higher than the dose that assessment to be protective of the effects to produce a toxic metabolite produced caused decreases in body weight gain in seen on the male reproductive system by other substances. For the purposes of the parental animals (9 mg/kg/day). and an additional safety factor to this tolerance action, therefore, EPA has However, when reproductive effects account for this qualitative assumed that linuron does not have a were examined, testicular atrophy was susceptibility is not necessary. common mechanism of toxicity with seen at the same dose (45 mg/kg/day) in iv. There are no residual uncertainties other substances. For information both studies. In both studies, while the identified in the exposure databases. regarding EPA’s efforts to determine F0 males were not affected, testicular The dietary food exposure assessments which chemicals have a common lesions and reduced fertility were seen were performed based on tolerance-level mechanism of toxicity and to evaluate in the F1 males. This effect in the F1 residues, 100 PCT for the acute the cumulative effects of such males is an indication of qualitative assessment and average PCT for chemicals, see EPA’s Web site at evidence of susceptibility. available commodities in the chronic http://www.epa.gov/pesticides/ 3. Conclusion. EPA has determined dietary assessment. EPA made cumulative. that reliable data show the safety of conservative (protective) assumptions in D. Safety Factor for Infants and infants and children would be the ground-water and surface water Children adequately protected if the FQPA SF modeling used to assess exposure to were reduced to 1X. That decision is linuron in drinking water. These 1. In general. Section 408(b)(2)(C) of based on the following findings: assessments will not underestimate the FFDCA provides that EPA shall apply i. The toxicity database for linuron is exposure and risks posed by linuron. an additional tenfold (10X) margin of complete. safety for infants and children in the ii. In an acute neurotoxicity study, E. Aggregate Risks and Determination of case of threshold effects to account for FOB findings of impaired mobility, Safety prenatal and postnatal toxicity and the alterations in gait, lack of coordination, EPA determines whether acute and completeness of the database on toxicity lowered body temperature, no reaction chronic dietary pesticide exposures are and exposure unless EPA determines to stimuli, low arousal, and decreases in safe by comparing aggregate exposure based on reliable data that a different motor activity were seen at the time of estimates to the acute PAD (aPAD) and margin of safety will be safe for infants peak effect (7 hours post dosing) on chronic PAD (cPAD). For linear cancer and children. This additional margin of study day 0. These observations were risks, EPA calculates the lifetime safety is commonly referred to as the mostly seen in the 500 mg/kg group and probability of acquiring cancer given the FQPA Safety Factor (SF). In applying no pathological changes were found in estimated aggregate exposure. Short-, this provision, EPA either retains the nervous system tissues. A clear NOAEL intermediate-, and chronic-term risks default value of 10X, or uses a different (20 mg/kg/day) was established, and are evaluated by comparing the additional safety factor when reliable this NOAEL was approximately 2–26X estimated aggregate food, water, and

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residential exposure to the appropriate enforce the tolerance expression. This residues from these uses. The points of PODs to ensure that an adequate MOE method involves reflux of crop samples departure selected for risk assessment exists. in strong base to hydrolyze residues of are protective of any effects on the 1. Acute risk. Using the exposure linuron and its metabolites to 3,4-DCA, hematopoietic system, including red assumptions discussed in this unit for which is analyzed using gas blood cells. Additionally, testing acute exposure, the acute dietary chromatography/mass spectrometry requirements for pesticide tolerances exposure from food and water to linuron (GC/MS). have been specified by rulemaking after will occupy 10% of the aPAD for all The method may be requested from: allowing for notice and comment by the infants less than 1 year old, the most Chief, Analytical Chemistry Branch, public and peer review by appropriate highly exposed U.S. population Environmental Science Center, 701 scientific bodies. See 40 CFR part 158 subgroup; and 5.7% of the aPAD for Mapes Rd., Ft. Meade, MD 20755–5350; for further information. females 13–49 years old. telephone number: (410) 305–2905; email address: residuemethods@ D. Revisions to Petitioned-for 2. Chronic risk. Using the exposure Tolerances assumptions described in this unit for epa.gov. Based on the data supporting the chronic exposure, EPA has concluded B. International Residue Limits that chronic exposure to linuron from petition, EPA has revised the proposed food and water will utilize 60% of the In making its tolerance decisions, EPA tolerances for several commodities, as cPAD for children 1–2 years old, the seeks to harmonize U.S. tolerances with follows: Cilantro, dried leaves from 27 population group receiving the greatest international standards whenever ppm to 10 ppm; dillweed, dried leaves exposure. There are no residential uses possible, consistent with U.S. food from 7.1 ppm to 5.0 ppm; dill, seed from for linuron. safety standards and agricultural 0.3 ppm to 0.5 ppm; dill, oil from 4.8 3. Short- and intermediate-term risk. practices. EPA considers the ppm to 2.0 ppm; parsley, leaves from Short- and intermediate-term aggregate international maximum residue limits 3.0 ppm to 4.0 ppm; parsley, dried exposure takes into account short- and (MRLs) established by the Codex leaves from 8.3 ppm to 9.0 ppm; and intermediate-term residential exposure Alimentarius Commission (Codex), as pea, dry, seed from 0.08 ppm to 0.09 plus chronic exposure to food and water required by FFDCA section 408(b)(4). ppm. The Agency revised the cilantro, (considered to be a background The Codex Alimentarius is a joint fresh leaves; dillweed, fresh leaves, and exposure level). Short- and United Nations Food and Agriculture pea, dry seed tolerance levels based on intermediate-term adverse effects were Organization/World Health analysis of the residue field trial data identified; however, linuron is not Organization food standards program, using the Organization for Economic registered for any use patterns that and it is recognized as an international Cooperation and Development (OECD) would result in short- or intermediate- food safety standards-setting tolerance calculation procedures. Due to term residential exposure. Short- and organization in trade agreements to a limited number of field trials, EPA intermediate-term risk is assessed based which the United States is a party. EPA used the formula of 5X the mean in on short- and intermediate-term may establish a tolerance that is order to establish tolerance levels for residential exposure plus chronic different from a Codex MRL; however, coriander, seed; dill, seed; and parsley, dietary exposure. Because there are no FFDCA section 408(b)(4) requires that leaves. Finally, for the dried herbs short- or intermediate-term residential EPA explain the reasons for departing (cilantro, dillweed, and parsley) and dill exposures and chronic dietary exposure from the Codex level. oil, the formula of the highest average The Codex has not established a MRL has already been assessed under the field trial (HAFT), multiplied by the for linuron. appropriately protective cPAD (which is concentration factor was used to at least as protective as the POD used to C. Response to Comments calculate the recommended tolerance assess short- or intermediate-term risks), levels for these commodities. These EPA received one comment to the concentration factors were derived from no further assessments of short- or notice of filing from November 7, 2012 intermediate-term risk are necessary, dividing the average dried or oil which opposed the use of linuron on commodity residue by the average fresh and EPA relies on the chronic dietary any food. The commenter expressed a risk assessment for evaluating the short- commodity residue. Based on this general opposition to the use of ‘‘toxic calculation method, all four tolerance and intermediate-term risks for linuron. chemicals’’ on food and further noted 4. Aggregate cancer risk for U.S. levels were decreased. that ‘‘red blood cells are harmed in Finally, the Agency has revised the population. Based on the discussion of animals from this toxic chemical.’’ The tolerance expression to clarify (1) that, carcinogenicity for linuron in Unit Agency understands the commenter’s as provided in FFDCA section 408(a)(3), III.A., EPA has concluded that the cPAD concerns and recognizes that some the tolerance covers metabolites and is protective of possible cancer effects. individuals believe that certain degradates of linuron not specifically Given the results of the chronic risk pesticide chemicals should not be mentioned; and (2) that compliance assessment, EPA has concluded that permitted in our food. However, the with the specified tolerance levels is to linuron does not pose a cancer risk. existing legal framework provided by be determined by measuring only 5. Determination of safety. Based on section 408 of the FFDCA states that these risk assessments, EPA concludes residues of linuron convertible to 3,4- tolerances may be set when the dichloroaniline. that there is a reasonable certainty that pesticide meets the safety standard no harm will result to the general imposed by that statute. The Agency is V. Conclusion population, or to infants and children required by Section 408 of the FFDCA Therefore, tolerances are established from aggregate exposure to linuron to estimate the risk of the potential for residues of linuron, 3-(3,4- residues. exposure to these residues. EPA has dichlorophenyl)-1-methoxy-1- IV. Other Considerations concluded, based on data submitted in methylurea), and its metabolites, in or support of the petition and other on cilantro, fresh leaves at 3.0 ppm; A. Analytical Enforcement Methodology reliable data, that there is a reasonable cilantro, dried leaves at 10 ppm; Adequate enforcement methodology, certainty that no harm will result from coriander, seed at 0.01 ppm; dillweed, Method ABC–68406–M, is available to aggregate human exposure to linuron fresh leaves at 1.5 ppm; dillweed, dried

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leaves at 5.0 ppm; dill, seed at 0.5 ppm; Children from Environmental Health Register. This action is not a ‘‘major dill, oil at 2.0 ppm; horseradish at 0.05 Risks and Safety Risks’’ (62 FR 19885, rule’’ as defined by 5 U.S.C. 804(2). ppm; parsley, leaves at 4.0 ppm; April 23, 1997). This final rule does not List of Subjects in 40 CFR Part 180 parsley, dried leaves at 9.0 ppm; and contain any information collections pea, dry, seed at 0.09 ppm. The subject to OMB approval under the Environmental protection, regulation additionally removes the Paperwork Reduction Act (PRA) (44 Administrative practice and procedure, tolerance in or on parsley, leaves at 0.25 U.S.C. 3501 et seq.), nor does it require Agricultural commodities, Pesticides ppm from 40 CFR 180.184(c). any special considerations under and pests, Reporting and recordkeeping Executive Order 12898, entitled requirements. VI. References ‘‘Federal Actions to Address Dated: January 24, 2014. The following literature was Environmental Justice in Minority Daniel J. Rosenblatt, referenced in the preamble of this Populations and Low-Income document. Acting Director, Registration Division, Office Populations’’ (59 FR 7629, February 16, of Pesticide Programs. 1. Gray, L; Wolf, C; Lambright, C; Mann, P; 1994). Price, M; Cooper, R; Ostby, J. 1999. Since tolerances and exemptions that Therefore, 40 CFR chapter I is Administration of potentially are established on the basis of a petition amended as follows: antiandrogenic pesticides (procymidone, under FFDCA section 408(d), such as linuron, iprodione, chlozolinate, p,p’- the tolerances in this final rule, do not PART 180—[AMENDED] DDE, and ketoconazole) and toxic require the issuance of a proposed rule, ■ 1. The authority citation for part 180 substances (dibutyl- and diethylhexyl the requirements of the Regulatory continues to read as follows: phthalate, PCB 169, and ethane Flexibility Act (RFA) (5 U.S.C. 601 et dimethane sulphonate) during sexual seq.), do not apply. Authority: 21 U.S.C. 321(q), 346a and 371. differentiation produces diverse profiles This final rule directly regulates of reproductive malformations in the ■ 2. In § 180.184: male rat. Toxicol Ind Health, 15 (1– growers, food processors, food handlers, ■ a. Revise the introductory text in 2):94–118. and food retailers, not States or tribes, paragraph (a). 2. Hotchkiss, A; Parks-Saldutti, L; Ostby, J; nor does this action alter the ■ b. Add ‘‘Cilantro, dried leaves’’, Lambright, C; Furr, J; Vandenbergh, J; & relationships or distribution of power Cilantro, fresh leaves’’, ‘‘Coriander, Gray, L. 2004. A mixture of the and responsibilities established by seed’’, ‘‘Dill, oil’’, ‘‘Dill, seed’’, ‘‘antiandrogens’’ linuron and butyl Congress in the preemption provisions ‘‘Dillweed, dried leaves’’, Dillweed, benzyl phthalate alters sexual of FFDCA section 408(n)(4). As such, fresh leaves’’, Horseradish’’, ‘‘Parsley, differentiation of the male rats in a the Agency has determined that this cumulative fashion. Biol.of Reprod dried leaves’’, ‘‘Parsley, leaves’’, and action will not have a substantial direct ‘‘Pea, dry, seed’’ to the table in 71:1852–1861. effect on States or tribal governments, 3. Lambright, C; Ostby, J; Bobseine, K; paragraph (a). on the relationship between the national Wilson, V; Hotchkiss, A; Mann, PC; ■ c. Revise the introductory text in Gray, L. 2000. Cellular and molecular government and the States or tribal paragraph (b). mechanisms of action of linuron: an governments, or on the distribution of ■ d. Revise the introductory text in antiandrogenic herbicide that produces power and responsibilities among the paragraph (c). various levels of government or between reproductive malformations in male rats. ■ e. Remove ‘‘Parsley, leaves’’ from the Toxicol Sci. 56(2):389–99. the Federal Government and Indian table in paragraph (c). 4. McIntyre, B; Barlow, N; Wallace, D; tribes. Thus, the Agency has determined The amendments read as follows: Maness, S; Gaido, K; Foster, P. 2000. that Executive Order 13132, entitled Effects of in utero exposure to linuron on ‘‘Federalism’’ (64 FR 43255, August 10, § 180.184 Linuron; tolerance for residues. androgen-dependent reproductive 1999) and Executive Order 13175, development in the male Crl:CD(SD)BR (a) General. Tolerances are rat. Toxicol Appl Pharmacol. 167(2):87– entitled ‘‘Consultation and Coordination established for residues of the herbicide 9. with Indian Tribal Governments’’ (65 FR linuron (3-(3,4-dichlorophenyl)-1- 5. Vinggaard, A., Breinholt, V., and Larsen, 67249, November 9, 2000) do not apply methoxy-1-methylurea), including its J. 1999. Screening of selected pesticides to this final rule. In addition, this final metabolites and degradates, in or on the for oestrogen receptor activation in vitro. rule does not impose any enforceable commodities in the table below. Food Addit Contam. 16(12):533–542. duty or contain any unfunded mandate Compliance with the tolerance levels VII. Statutory and Executive Order as described under Title II of the specified below is to be determined by Reviews Unfunded Mandates Reform Act of 1995 measuring only those linuron residues (UMRA) (2 U.S.C. 1501 et seq.). convertible to 3,4-dichloroaniline, This final rule establishes tolerances This action does not involve any calculated as the stoichiometric under FFDCA section 408(d) in technical standards that would require equivalent of linuron, in or on the response to a petition submitted to the Agency consideration of voluntary commodity: Agency. The Office of Management and consensus standards pursuant to section Budget (OMB) has exempted these types 12(d) of the National Technology Parts per of actions from review under Executive Transfer and Advancement Act of 1995 Commodity million Order 12866, entitled ‘‘Regulatory (NTTAA) (15 U.S.C. 272 note). Planning and Review’’ (58 FR 51735, October 4, 1993). Because this final rule VIII. Congressional Review Act ***** has been exempted from review under Pursuant to the Congressional Review Cilantro, dried leaves ...... 10 Executive Order 12866, this final rule is Act (5 U.S.C. 801 et seq.), EPA will Cilantro, fresh leaves ...... 3 .0 Coriander, seed ...... 0 .01 not subject to Executive Order 13211, submit a report containing this rule and entitled ‘‘Actions Concerning other required information to the U.S. ***** Regulations That Significantly Affect Senate, the U.S. House of Dill, oil ...... 2 .0 Energy Supply, Distribution, or Use’’ (66 Representatives, and the Comptroller Dill, seed ...... 0 .5 FR 28355, May 22, 2001) or Executive General of the United States prior to Dillweed, dried leaves ...... 5 .0 Order 13045, entitled ‘‘Protection of publication of the rule in the Federal Dillweed, fresh leaves ...... 1 .5

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Parts per SUMMARY: The Federal Communications the provision of satellite communication Commodity million Commission (FCC) has adopted many services. Sixteen parties filed comments changes in its rules, which governs in response to the NPRM and 10 parties licensing and operation of space stations filed reply comments. In this Report and ***** and earth stations. Collectively, the Order, we adopt most of the changes Horseradish ...... 0.05 changes adopted in this document will proposed previously and discuss ***** streamline the Commission’s recommendations for further changes. In Parsley, dried leaves ...... 9.0 regulations, fostering more rapid all, we revise over 150 rule provisions Parsley, leaves ...... 4.0 deployment of services to the public, in part 25 to better reflect evolving greater investment, and new technology; eliminate unnecessary ***** innovations in satellite services. information filing requirements for Pea, dry, seed ...... 0.09 DATES: The rules in this document licensees and applicants; eliminate contain information collection unnecessary technical restrictions; ***** requirements that have not been reorganize existing requirements; approved by Office of Management and eliminate redundancy and unnecessary * * * * * verbiage; clarify vague, confusing, or (b) Section 18 emergency exemptions. Budget. The Commission will publish a ambiguous provisions; resolve Time-limited tolerances are established document in the Federal Register inconsistencies; and codify existing for residues of the herbicide linuron [3- announcing such OMB approval, the policies to improve transparency. These (3,4-dichlorophenyl)-1-methoxy-1- effective date of all of the rule changes will better enable the methylurea], including its metabolites amendments adopted in the Report and Commission to assess the interference and degradates, in or on the Order, and the approval date of the potential of proposed operations; afford commodities in the table below, incorporation by reference of a certain more operational flexibility for satellite resulting from use of the pesticide publication listed in the rule. licensees; enable applicants and pursuant to FIFRA section 18 FOR FURTHER INFORMATION CONTACT: licensees to conserve time, effort, and emergency exemptions. Compliance William Bell (202) 418–0741, Satellite expense in preparing applications and with the tolerance levels specified Division, International Bureau, Federal reports; ease administrative burdens for below is to be determined by measuring Communications Commission, the Commission; and make the rules only those linuron residues convertible Washington, DC 20554. For additional easier to understand. to 3.4-dichloroaniline, calculated as the information concerning the information stoichiometric equivalent of linuron, in collection(s) contained in this Paperwork Reduction Act or on the commodity. The tolerance document, contact Leslie Smith at 202– 2. This document contains new or expires and is revoked on the date 418–0217, or via the Internet at modified information collection specified in the table. [email protected]. SUPPLEMENTARY INFORMATION: This is a requirements subject to the Paperwork * * * * * Reduction Act of 1995 (PRA), Public (c) Tolerances with regional summary of the Commission’s Report and Order in IB Docket No. 12–267, FCC Law 104–13. It will be submitted to the registrations. Tolerances with regional Office of Management and Budget registrations, as defined in § 180.1(l), are 13–111, adopted and released on August 9, 2013. The full text of the Report and (OMB) for review under Section 3507(d) established for residues of the herbicide of the PRA. OMB, the general public, linuron (3-(3,4-dichlorophenyl)-1- Order is available for public inspection and copying during regular business and other Federal agencies are invited to methoxy-1-methylurea), including its comment on the new or modified metabolites and degradates, in or on the hours at the FCC Reference Information Center, Portals II, 445 12th Street SW., information collection requirements commodities in the table below. contained in this proceeding. Compliance with the tolerance levels Room CY–A257, Washington, DC 20554. specified below is to be determined by This document may also be purchased 3. Pursuant to the Small Business measuring only those linuron residues from the Commission’s duplicating Paperwork Relief Act of 2002, Public convertible to 3,4-dichloroaniline, contractor, Best Copy and Printing, Inc., Law 107–198, see 44 U.S.C. 3506(c)(4), calculated as the stoichiometric Portals II, 445 12th Street SW., Room we previously sought specific comment equivalent of linuron, in or on the CY–B402, Washington, DC 20554, on how the Commission might further commodity. telephone 202–488–5300, facsimile reduce the information collection 202–488–5563, or via email FCC@ burden for small business concerns with * * * * * fewer than 25 employees. We received [FR Doc. 2014–03077 Filed 2–11–14; 8:45 am] BCPIWEB.com. The full text may also be downloaded at http://apps.fcc.gov/ecfs/ no comments on this issue. We have BILLING CODE 6560–50–P document/view?id=7520937207 http:// assessed the effects of the revisions www.fcc.gov. Alternative formats are adopted that might impose information available to person with disabilities by collection burdens on small business FEDERAL COMMUNICATIONS sending an email to [email protected] or concerns, and find that the impact on COMMISSION calling the Consider & Governmental businesses with fewer than 25 employees will be an overall reduction 47 CFR Part 25 Affairs Bureau at 202–418–0530 (voice), or 202–418–0432 (tty). in burden. The amendments adopted in [IB Docket No. 12–267; FCC 13–111] this Report and Order eliminate Synopsis unnecessary information filing Comprehensive Review of Licensing 1. In September 2012, the requirements for licensees and and Operating Rules for Satellite Commission issued a Notice of applicants; eliminate unnecessary Services Proposed Rulemaking (NPRM), 77 FR technical restrictions and enable AGENCY: Federal Communications 67172, November 8, 2012 proposing applicants and licensees to conserve Commission. extensive changes in part 25 of its rules, time, effort, and expense in preparing which governs licensing and operation applications and reports. Overall, these ACTION: Final rule. of space stations and earth stations for changes may have a greater positive

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