81 FR 70038 - Mandestrobin; Pesticide Tolerances
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 81, Issue 196 (October 11, 2016)
Federal Register Volume 81, Issue 196 (October 11, 2016)
| Page Range | 70038-70043 | |
| FR Document | 2016-24492 |
[Federal Register Volume 81, Number 196 (Tuesday, October 11, 2016)] [Rules and Regulations] [Pages 70038-70043] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-24492] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2014-0285; FRL-9945-37] Mandestrobin; Pesticide Tolerances AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This regulation establishes tolerances for residues of S-2200 (here after referred to within this document as mandestrobin) in or on multiple commodities which are identified and discussed later in this document. Valent U.S.A., Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective October 11, 2016. Objections and requests for hearings must be received on or before December 12, 2016, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). ADDRESSES: The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2014-0285, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address: [email protected]. SUPPLEMENTARY INFORMATION: I. General Information A. Does this action apply to me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather [[Page 70039]] provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:Crop production (NAICS code 111). Animal production (NAICS code 112). Food manufacturing (NAICS code 311). Pesticide manufacturing (NAICS code 32532). B. How can I get electronic access to other related information? You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. C. How can I file an objection or hearing request? Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2014-0285 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before December 12, 2016. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b). In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2014-0285, by one of the following methods: Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute. Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001. Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets. II. Summary of Petitioned-for Tolerances In the Federal Register of December 17, 2014 (79 FR 75107) (FRL- 9918-90), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 3F8224) by Valent U.S.A., Corporation,1600 Riviera Ave., Suite 200, Walnut Creek, California, 94596. The petition requested that 40 CFR 180 be amended by establishing tolerances for residues of the fungicide mandestrobin, (2-[(2,5-dimethylphenoxy)methyl]-[alpha]-methoxy-N- methyl-benzeneacetamide), in or on small fruit vine climbing except fuzzy kiwifruit crop subgroup 13-07F, fruit at 5 parts per million (ppm), juice at 7 ppm, and dried fruit at 10 ppm; low growing berry subgroup 13-07G, fruit at 3 ppm; and rapeseed crop subgroup 20A, seed at 0.6 ppm. That document referenced a summary of the petition prepared by Valent U.S.A. Corporation, the registrant, which is available to the public in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing. Based upon review of the data supporting the petition, EPA lowered the requested tolerance levels for grape, raisin. Tolerances for juice and dried fruit are not required. At this time, EPA is not granting a tolerance for rapeseed crop group 20A. The reason for these changes is explained in Unit IV.C. III. Aggregate Risk Assessment and Determination of Safety Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.'' This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ``ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .'' Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for mandestrobin including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with mandestrobin as follows. A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The main target organs for mandestrobin toxicity in all mammalian species tested are the liver and gall bladder with effects ranging from hepatocyte hypertrophy and increased liver weight (usually considered not adverse in the absence of corroborative hepatic enzyme changes or histopathology) to centrilobular degeneration, hepatocyte and bile duct pigmentation, periductular inflammation and gall stones. Dogs were more sensitive to the adverse liver effects than rats; mice showed only non- adverse liver effects. Thyroid effects were observed in rats (increased weight, follicular cell hypertrophy, decreased serum hormone levels) at higher doses than early signs of liver effects suggesting that effects in the thyroid may be secondary to liver effects. Gonadal effects were observed at higher doses than the liver effects, and were more evident in dogs (immature prostate and/or testes, low sperm count, immature ovaries, decrease uterus weight) but equivocal and/or not adverse in rats. Gonadal effects did not affect the reproductive capacity of rats. No developmental effects were observed in rats or rabbits, and no adverse reproductive, immunotoxic, or neurotoxic effects were observed in any of the studies. No adverse effects were [[Page 70040]] seen in a route-specific dermal toxicity study. Mutagenicity studies were negative. There is no evidence of carcinogenicity because there was no increase in tumor incidence in rat and mouse long-term studies. The Agency classified mandestrobin as ``not likely to be a human carcinogen''. Specific information on the studies received and the nature of the toxic effects caused by mandestrobin as well as the no-observed- adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect- level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in: Mandestrobin. Human Health Risk Assessment for Proposed Foliar Uses on Small Fruit Vine Climbing (Except Fuzzy Kiwifruit) (Subgroup 13-07F), Low Growing Berry (Subgroup 13-07G) (Except Cranberry), Turf, and Seed Treatment Uses on Corn (Field, Pop, Sweet), Sorghum Grain (Milo), and Legume Vegetables (Crop Group 6C) (Except Cowpea and Field Pea) at page 18 in docket ID number EPA-HQ- OPP-2014-0285. B. Toxicological Points of Departure/Levels of Concern Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level--generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)--and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm. A summary of the toxicological endpoints for mandestrobin used for human risk assessment is shown in Table 1. Table 1--Summary of Toxicological Doses and Endpoints for Mandestrobin 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 (General population No toxicity was observed that could be attributed to a single exposure. including infants and children). ---------------------------------------------------------------------------------------------------------------- Chronic dietary (All populations) NOAEL = 92 mg/kg/day Chronic RfD = 0.92 Chronic Toxicity--Dog LOAEL = 181 mg/kg/day. mg/kg/day based on incidence of cPAD = 0.92 mg/kg/ liver centrilobular degeneration, day. hepatocytehypertrophy, hepatocyte pigment, and elevated serum ALP and ALT. Incidental Oral Short-Term (1-30 UFA = 10x........... LOC for MOE <100... Additional supportive study: days) and Intermediate-Term (1-6 Subchronic Toxicity--Dog NOAEL = months). 91 mg/kg/day LOAEL = 268 mg/kg/day based on incidence of liver centrilobular degeneration in both sexes and elevated serum ALP in females. Inhalation Short-Term (1-30 days) UFH = 10x........... and Intermediate-Term (1-6 FQPA SF = 1x........ months). ---------------------------------------------------------------------------------------------------------------- Dermal Short-Term (1-30 days) and No hazard was identified for dermal exposure; therefore a quantitative dermal Intermediate-Term (1-6 months), assessment is not needed. all populations. ---------------------------------------------------------------------------------------------------------------- Cancer (Oral, dermal, inhalation) Not likely a human carcinogen. ---------------------------------------------------------------------------------------------------------------- NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern. ALP = alkaline phosphatase. ALT = alanine aminotransferase. C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to mandestrobin, EPA considered exposure from the petitioned- for tolerances only as there are no existing mandestrobin tolerances. EPA assessed dietary exposures from mandestrobin in food as follows: i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. No such effects were identified in the toxicological studies for mandestrobin; therefore, a quantitative acute dietary exposure assessment is unnecessary. ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the U.S. Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in food, EPA assumed tolerance-level residues, 100 percent crops treated (PCT), and default processing factors for all proposed commodities. iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that mandestrobin does not [[Page 70041]] pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary. iv. Anticipated residue and PCT information. EPA did not use anticipated residue or PCT information in the dietary assessment for mandestrobin. Tolerance-level residues and 100 PCT were assumed for all food commodities. 2. Dietary exposure from drinking water. The Agency used screening- level water exposure models in the dietary exposure analysis and risk assessment for mandestrobin in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of mandestrobin. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide. Based on the First Index Reservoir Screening Tool (FIRST) and Pesticide Root Zone Model Ground Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of mandestrobin for chronic exposures for non-cancer assessments are estimated to be 38 parts per billion (ppb) for surface water and 3.9 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the water concentration of value 38 ppb was used to assess the contribution to drinking water. 3. From non-dietary exposure. The term ``residential exposure'' is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Mandestrobin is currently proposed for use on turf at golf courses, sod farms, recreational/athletic fields, and residential/commercial lawns. EPA assessed residential exposure using the following scenarios. For residential handlers, the worst-case scenario was determined to be short-term inhalation exposures to adults from mixing, loading, and applying mandestrobin to turf. For post-application exposures, the worst-case scenario was determined to be short-term post-application incidental oral exposure to children from hand-to-mouth activities on turf. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide. 4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider ``available information'' concerning the cumulative effects of a particular pesticide's residues and ``other substances that have a common mechanism of toxicity.'' EPA has not found mandestrobin to share a common mechanism of toxicity with any other substances, and mandestrobin does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that mandestrobin does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides. D. Safety Factor for Infants and Children 1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA Safety Factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor. 2. Prenatal and postnatal sensitivity. There is no evidence of sensitivity/susceptibility in the offspring following mandestrobin exposure, including developmental toxicity studies in rats and rabbits, and a 2-generation reproductive study in rats. Although pup weights were decreased in the rat reproductive study, this change was observed at the same dose as maternal liver effects, which included periportal/ bile duct pigment, periductular inflammatory cell infiltration, and bile duct proliferation. 3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings: i. The toxicity database for the mandestrobin tolerances being established is complete. ii. There is no indication that mandestrobin is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. iii. There is no evidence that mandestrobin results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study. iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to mandestrobin in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by mandestrobin. E. Aggregate Risks and Determination of Safety EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists. 1. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, mandestrobin is not expected to pose an acute risk. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to mandestrobin from food and water will utilize 2.6% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to [[Page 70042]] residues of mandestrobin is not expected. 3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Mandestrobin could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to mandestrobin. Using the exposure assumptions described in this unit for short- term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 19,000 for adults and 2,900 for children 1-2 years old. Because EPA's level of concern for mandestrobin is a MOE of 100 or below, these MOEs are not of concern. 4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Since the short-and intermediate-term PODs are the same and short-term exposure estimates are greater than their intermediate-term counterparts, the short-term aggregate risk assessment is protective of the intermediate-term aggregate exposure. Therefore a separate intermediate-term aggregate assessment is not necessary. 5. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, mandestrobin is not expected to pose a cancer risk to humans. 6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to mandestrobin residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (RM-48C-2A, which uses high performance liquid chromatography with tandem mass spectrometry (HPLC/ MS-MS)) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: [email protected]. B. International Residue Limits In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. The Codex has not established a MRL for mandestrobin. C. Revisions to Petitioned-for Tolerances Based on an analysis of residue levels from crop field trials, EPA is establishing a tolerance for grape, raisin at 7 ppm, rather than the requested level of 10 ppm. The highest average field trial (HAFT) for grape and the processing factor for raisins supports a 7 ppm tolerance. The petitioner requested tolerances for juice and dried fruit covered under crop subgroup 13-07F, small fruit. The available processing data for grape, the representative commodity for subgroup 13-07F, indicates that residues in juice will be covered by the tolerance being established for subgroup 13-07F. At this time, the Agency is not aware of any dried commodities derived from crops in subgroup 13-07F other than raisin, for which the Agency is establishing a separate tolerance, as indicated in the paragraph above. After the petitioner submitted its petition for tolerances on subgroup 13-07G, it withdrew its request to include cranberry; therefore, the Agency is only establishing tolerances for subgroup 13- 07G, except cranberry. At this time, EPA is not establishing a tolerance for rapeseed subgroup 20A. The full three year freezer storage stability data (OPPTS guideline number 860.1380) for crop field trial data are needed to support tolerances. These data are required since samples from crop field trials are often stored for a number of years prior to analysis. Therefore, it is a requirement to ensure that the residues that are found multiple years later are actually representative of the residues that would be found on the day of harvest. This ensures that the Agency has set a tolerance high enough to cover residues expected in/on the commodity of interest. Accordingly, EPA has not made a determination with regard to this petitioned-for tolerance at this time. V. Conclusion Therefore, tolerances are established for residues of mandestrobin, 2-[(2,5-dimethylphenoxy)methyl]-[alpha]-methoxy-N- methylbenzeneacetamide, in or on berry, low growing, subgroup 13-07G, except cranberry at 3.0 ppm; fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13-07F at 5.0 ppm; grape, raisin at 7.0 ppm. VI. Statutory and Executive Order Reviews This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled ``Regulatory Planning and Review'' (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled ``Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of Children from Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled ``Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations'' (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply. This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency [[Page 70043]] has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled ``Consultation and Coordination with Indian Tribal Governments'' (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note). VII. Congressional Review Act Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a ``major rule'' as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: September 30, 2016. Jack E. Housenger, Director, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180--[AMENDED] 0 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371. 0 2. Add Sec. 180.690 to subpart C to read as follows: Sec. 180.690 Mandestrobin; tolerances for residues. (a) General. Tolerances are established for residues of mandestrobin, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only mandestrobin, 2- [(2,5-dimethylphenoxy)methyl]-[alpha]-methoxy-N-methylbenzeneacetamide. ------------------------------------------------------------------------ Parts per Commodity million ------------------------------------------------------------------------ Berry, low growing, subgroup 13-07G, except cranberry...... 3.0 Fruit, small vine climbing, except fuzzy kiwifruit, 5.0 subgroup 13-07F........................................... Grape, raisin.............................................. 7.0 ------------------------------------------------------------------------ (b) Section 18 emergency exemptions. [Reserved] (c) Tolerances with regional registrations. [Reserved] (d) Indirect or inadvertent tolerances. [Reserved] [FR Doc. 2016-24492 Filed 10-7-16; 8:45 am] BILLING CODE 6560-50-P
![70038 Federal Register / Vol. 81, No. 196 / Tuesday, October 11, 2016 / Rules and Regulations
FIRE SUPPRESSION AND EXPLOSION PROTECTION—Continued
End-use Substitute Decision Further information
• In the case that Solstice® FS is inhaled, person(s) should be
immediately removed and exposed to fresh air; if breathing is dif-
ficult, person(s) should seek medical attention;
• Eye wash and quick drench facilities should be available. In
case of ocular exposure, person(s) should immediately flush the
eyes, including under the eyelids, with water for 15 minutes; should
frostbite occur, affected areas should be rinsed with lukewarm
water, and medical attention should be sought if irritation develops
or persists;
• In the case of dermal exposure, the SDS recommends that per-
son(s) should immediately wash the affected area with water and re-
move all contaminated clothing to avoid irritation; should frostbite
occur, bathe (do not rub) the affected area with lukewarm, no hot,
water. If water is not available, cover the affected area with a clean
soft cloth; and medical attention should be sought if irritation devel-
ops or persists.
• Although unlikely, in case of ingestion of Solstice® FS, the per-
son(s) should drink a cup of water, if fully conscious, and consult a
physician immediately;
• Manufacturing space should be equipped with engineering con-
trols, specifically an adequate exhaust ventilation system, to effec-
tively mitigate potential occupational exposure;
• Employees responsible for chemical processing should wear
the appropriate personal protective equipment (PPE), such as pro-
tective gloves, tightly sealed goggles, protective work clothing, and
suitable respiratory protection in case of accidental release or insuf-
ficient ventilation;
• All spills should be cleaned up immediately in accordance with
good industrial hygiene practices;\
• Training for safe handling procedures should be provided to all
employees that would be likely to handle containers of the agent or
extinguishing units filled with the agent;
See additional comments 1, 2, 3, 4, 5.
1. The EPA recommends that users consult Section VIII of the OSHA Technical Manual for information on selecting the appropriate types of
personal protective equipment for all listed fire suppression agents. The EPA has no intention of duplicating or displacing OSHA coverage related
to the use of personal protective equipment (e.g., respiratory protection), fire protection, hazard communication, worker training or any other oc-
cupational safety and health standard with respect to halon substitutes.
2. Use of all listed fire suppression agents should conform to relevant OSHA requirements, including 29 CFR part 1910, subpart L, sections
1910.160 and 1910.162.
3. Per OSHA requirements, protective gear (SCBA) should be available in the event personnel should reenter the area.
4. Discharge testing should be strictly limited to that which is essential to meet safety or performance requirements.
5. The agent should be recovered from the fire protection system in conjunction with testing or servicing, and recycled for later use or
destroyed.
[FR Doc. 2016–24381 Filed 10–7–16; 8:45 am] DATES: This regulation is effective Docket is (703) 305–5805. Please review
BILLING CODE 6560–50–P October 11, 2016. Objections and the visitor instructions and additional
requests for hearings must be received information about the docket available
on or before December 12, 2016, and at http://www.epa.gov/dockets.
ENVIRONMENTAL PROTECTION must be filed in accordance with the FOR FURTHER INFORMATION CONTACT:
AGENCY instructions provided in 40 CFR part Susan Lewis, Registration Division
178 (see also Unit I.C. of the (7505P), Office of Pesticide Programs,
40 CFR Part 180 SUPPLEMENTARY INFORMATION). Environmental Protection Agency, 1200
[EPA–HQ–OPP–2014–0285; FRL–9945–37] ADDRESSES: The docket for this action, Pennsylvania Ave. NW., Washington,
identified by docket identification (ID) DC 20460–0001; main telephone
Mandestrobin; Pesticide Tolerances number EPA–HQ–OPP–2014–0285, is number: (703) 305–7090; email address:
AGENCY: Environmental Protection available at http://www.regulations.gov RDFRNotices@epa.gov.
Agency (EPA). or at the Office of Pesticide Programs
SUPPLEMENTARY INFORMATION:
ACTION: Final rule. Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency I. General Information
SUMMARY: This regulation establishes Docket Center (EPA/DC), West William
A. Does this action apply to me?
tolerances for residues of S–2200 (here Jefferson Clinton Bldg., Rm. 3334, 1301
after referred to within this document as Constitution Ave. NW., Washington, DC You may be potentially affected by
ehiers on DSK5VPTVN1PROD with RULES
mandestrobin) in or on multiple 20460–0001. The Public Reading Room this action if you are an agricultural
commodities which are identified and is open from 8:30 a.m. to 4:30 p.m., producer, food manufacturer, or
discussed later in this document. Valent Monday through Friday, excluding legal pesticide manufacturer. The following
U.S.A., Corporation requested these holidays. The telephone number for the list of North American Industrial
tolerances under the Federal Food, Public Reading Room is (202) 566–1744, Classification System (NAICS) codes is
Drug, and Cosmetic Act (FFDCA). and the telephone number for the OPP not intended to be exhaustive, but rather
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![Federal Register / Vol. 81, No. 196 / Tuesday, October 11, 2016 / Rules and Regulations 70039
provides a guide to help readers • Hand Delivery: To make special give special consideration to exposure
determine whether this document arrangements for hand delivery or of infants and children to the pesticide
applies to them. Potentially affected delivery of boxed information, please chemical residue in establishing a
entities may include: follow the instructions at http:// tolerance and to ‘‘ensure that there is a
• Crop production (NAICS code 111). www.epa.gov/dockets/contacts.html. reasonable certainty that no harm will
• Animal production (NAICS code Additional instructions on commenting result to infants and children from
112). or visiting the docket, along with more aggregate exposure to the pesticide
• Food manufacturing (NAICS code information about dockets generally, is chemical residue. . . .’’
311). available at http://www.epa.gov/ Consistent with FFDCA section
• Pesticide manufacturing (NAICS dockets. 408(b)(2)(D), and the factors specified in
code 32532). FFDCA section 408(b)(2)(D), EPA has
II. Summary of Petitioned-for reviewed the available scientific data
B. How can I get electronic access to Tolerances and other relevant information in
other related information? In the Federal Register of December support of this action. EPA has
17, 2014 (79 FR 75107) (FRL–9918–90), sufficient data to assess the hazards of
You may access a frequently updated
EPA issued a document pursuant to and to make a determination on
electronic version of 40 CFR part 180
FFDCA section 408(d)(3), 21 U.S.C. aggregate exposure for mandestrobin
through the Government Printing
346a(d)(3), announcing the filing of a including exposure resulting from the
Office’s e-CFR site at http://
pesticide petition (PP 3F8224) by Valent tolerances established by this action.
www.ecfr.gov/cgi-bin/text-
U.S.A., Corporation,1600 Riviera Ave., EPA’s assessment of exposures and risks
idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
Suite 200, Walnut Creek, California, associated with mandestrobin as
40tab_02.tpl.
94596. The petition requested that 40 follows.
C. How can I file an objection or hearing CFR 180 be amended by establishing
request? tolerances for residues of the fungicide A. Toxicological Profile
mandestrobin, (2-[(2,5- EPA has evaluated the available
Under FFDCA section 408(g), 21 toxicity data and considered its validity,
dimethylphenoxy)methyl]-a-methoxy-
U.S.C. 346a, any person may file an completeness, and reliability as well as
N-methyl-benzeneacetamide), in or on
objection to any aspect of this regulation the relationship of the results of the
small fruit vine climbing except fuzzy
and may also request a hearing on those studies to human risk. EPA has also
kiwifruit crop subgroup 13–07F, fruit at
objections. You must file your objection considered available information
5 parts per million (ppm), juice at 7
or request a hearing on this regulation ppm, and dried fruit at 10 ppm; low concerning the variability of the
in accordance with the instructions growing berry subgroup 13–07G, fruit at sensitivities of major identifiable
provided in 40 CFR part 178. To ensure 3 ppm; and rapeseed crop subgroup subgroups of consumers, including
proper receipt by EPA, you must 20A, seed at 0.6 ppm. That document infants and children.
identify docket ID number EPA–HQ– referenced a summary of the petition The main target organs for
OPP–2014–0285 in the subject line on prepared by Valent U.S.A. Corporation, mandestrobin toxicity in all mammalian
the first page of your submission. All the registrant, which is available to the species tested are the liver and gall
objections and requests for a hearing public in the docket, http:// bladder with effects ranging from
must be in writing, and must be www.regulations.gov. There were no hepatocyte hypertrophy and increased
received by the Hearing Clerk on or comments received in response to the liver weight (usually considered not
before December 12, 2016. Addresses for notice of filing. adverse in the absence of corroborative
mail and hand delivery of objections Based upon review of the data hepatic enzyme changes or
and hearing requests are provided in 40 supporting the petition, EPA lowered histopathology) to centrilobular
CFR 178.25(b). the requested tolerance levels for grape, degeneration, hepatocyte and bile duct
In addition to filing an objection or raisin. Tolerances for juice and dried pigmentation, periductular
hearing request with the Hearing Clerk fruit are not required. At this time, EPA inflammation and gall stones. Dogs were
as described in 40 CFR part 178, please is not granting a tolerance for rapeseed more sensitive to the adverse liver
submit a copy of the filing (excluding crop group 20A. The reason for these effects than rats; mice showed only non-
any Confidential Business Information changes is explained in Unit IV.C. adverse liver effects.
(CBI)) for inclusion in the public docket. Thyroid effects were observed in rats
Information not marked confidential III. Aggregate Risk Assessment and
(increased weight, follicular cell
pursuant to 40 CFR part 2 may be Determination of Safety
hypertrophy, decreased serum hormone
disclosed publicly by EPA without prior Section 408(b)(2)(A)(i) of FFDCA levels) at higher doses than early signs
notice. Submit the non-CBI copy of your allows EPA to establish a tolerance (the of liver effects suggesting that effects in
objection or hearing request, identified legal limit for a pesticide chemical the thyroid may be secondary to liver
by docket ID number EPA–HQ–OPP– residue in or on a food) only if EPA effects.
2014–0285, by one of the following determines that the tolerance is ‘‘safe.’’ Gonadal effects were observed at
methods: Section 408(b)(2)(A)(ii) of FFDCA higher doses than the liver effects, and
• Federal eRulemaking Portal: http:// defines ‘‘safe’’ to mean that ‘‘there is a were more evident in dogs (immature
www.regulations.gov. Follow the online reasonable certainty that no harm will prostate and/or testes, low sperm count,
instructions for submitting comments. result from aggregate exposure to the immature ovaries, decrease uterus
Do not submit electronically any pesticide chemical residue, including weight) but equivocal and/or not
information you consider to be CBI or all anticipated dietary exposures and all adverse in rats. Gonadal effects did not
ehiers on DSK5VPTVN1PROD with RULES
other information whose disclosure is other exposures for which there is affect the reproductive capacity of rats.
restricted by statute. reliable information.’’ This includes No developmental effects were
• Mail: OPP Docket, Environmental exposure through drinking water and in observed in rats or rabbits, and no
Protection Agency Docket Center (EPA/ residential settings, but does not include adverse reproductive, immunotoxic, or
DC), (28221T), 1200 Pennsylvania Ave. occupational exposure. Section neurotoxic effects were observed in any
NW., Washington, DC 20460–0001. 408(b)(2)(C) of FFDCA requires EPA to of the studies. No adverse effects were
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![70042 Federal Register / Vol. 81, No. 196 / Tuesday, October 11, 2016 / Rules and Regulations
residues of mandestrobin is not B. International Residue Limits the residues that would be found on the
expected. In making its tolerance decisions, EPA day of harvest. This ensures that the
3. Short-term risk. Short-term seeks to harmonize U.S. tolerances with Agency has set a tolerance high enough
aggregate exposure takes into account international standards whenever to cover residues expected in/on the
short-term residential exposure plus possible, consistent with U.S. food commodity of interest. Accordingly,
chronic exposure to food and water safety standards and agricultural EPA has not made a determination with
(considered to be a background practices. EPA considers the regard to this petitioned-for tolerance at
exposure level). Mandestrobin could this time.
international maximum residue limits
result in short-term residential (MRLs) established by the Codex V. Conclusion
exposure, and the Agency has Alimentarius Commission (Codex), as
determined that it is appropriate to Therefore, tolerances are established
required by FFDCA section 408(b)(4). for residues of mandestrobin, 2-[(2,5-
aggregate chronic exposure through food The Codex Alimentarius is a joint
and water with short-term residential dimethylphenoxy)methyl]-a-methoxy-
United Nations Food and Agriculture N-methylbenzeneacetamide, in or on
exposures to mandestrobin. Organization/World Health
Using the exposure assumptions berry, low growing, subgroup 13–07G,
Organization food standards program, except cranberry at 3.0 ppm; fruit, small
described in this unit for short-term and it is recognized as an international
exposures, EPA has concluded the vine climbing, except fuzzy kiwifruit,
food safety standards-setting subgroup 13–07F at 5.0 ppm; grape,
combined short-term food, water, and organization in trade agreements to
residential exposures result in aggregate raisin at 7.0 ppm.
which the United States is a party. EPA
MOEs of 19,000 for adults and 2,900 for may establish a tolerance that is VI. Statutory and Executive Order
children 1–2 years old. Because EPA’s different from a Codex MRL; however, Reviews
level of concern for mandestrobin is a FFDCA section 408(b)(4) requires that This action establishes tolerances
MOE of 100 or below, these MOEs are EPA explain the reasons for departing under FFDCA section 408(d) in
not of concern. from the Codex level. response to a petition submitted to the
4. Intermediate-term risk. The Codex has not established a MRL Agency. The Office of Management and
Intermediate-term aggregate exposure for mandestrobin. Budget (OMB) has exempted these types
takes into account intermediate-term
of actions from review under Executive
residential exposure plus chronic C. Revisions to Petitioned-for Tolerances
Order 12866, entitled ‘‘Regulatory
exposure to food and water (considered Based on an analysis of residue levels Planning and Review’’ (58 FR 51735,
to be a background exposure level). from crop field trials, EPA is October 4, 1993). Because this action
Since the short-and intermediate-term establishing a tolerance for grape, raisin has been exempted from review under
PODs are the same and short-term at 7 ppm, rather than the requested level Executive Order 12866, this action is
exposure estimates are greater than their of 10 ppm. The highest average field not subject to Executive Order 13211,
intermediate-term counterparts, the trial (HAFT) for grape and the entitled ‘‘Actions Concerning
short-term aggregate risk assessment is processing factor for raisins supports a Regulations That Significantly Affect
protective of the intermediate-term 7 ppm tolerance. Energy Supply, Distribution, or Use’’ (66
aggregate exposure. Therefore a separate The petitioner requested tolerances FR 28355, May 22, 2001) or Executive
intermediate-term aggregate assessment for juice and dried fruit covered under Order 13045, entitled ‘‘Protection of
is not necessary. crop subgroup 13–07F, small fruit. The Children from Environmental Health
5. Aggregate cancer risk for U.S. available processing data for grape, the Risks and Safety Risks’’ (62 FR 19885,
population. Based on the lack of representative commodity for subgroup April 23, 1997). This action does not
evidence of carcinogenicity in two 13–07F, indicates that residues in juice contain any information collections
adequate rodent carcinogenicity studies, will be covered by the tolerance being subject to OMB approval under the
mandestrobin is not expected to pose a established for subgroup 13–07F. At this Paperwork Reduction Act (PRA) (44
cancer risk to humans. time, the Agency is not aware of any U.S.C. 3501 et seq.), nor does it require
6. Determination of safety. Based on dried commodities derived from crops any special considerations under
these risk assessments, EPA concludes in subgroup 13–07F other than raisin, Executive Order 12898, entitled
that there is a reasonable certainty that for which the Agency is establishing a ‘‘Federal Actions to Address
no harm will result to the general separate tolerance, as indicated in the Environmental Justice in Minority
population, or to infants and children paragraph above. Populations and Low-Income
from aggregate exposure to After the petitioner submitted its Populations’’ (59 FR 7629, February 16,
mandestrobin residues. petition for tolerances on subgroup 13– 1994).
IV. Other Considerations 07G, it withdrew its request to include Since tolerances and exemptions that
cranberry; therefore, the Agency is only are established on the basis of a petition
A. Analytical Enforcement Methodology establishing tolerances for subgroup 13– under FFDCA section 408(d), such as
Adequate enforcement methodology 07G, except cranberry. the tolerances in this final rule, do not
(RM–48C–2A, which uses high At this time, EPA is not establishing require the issuance of a proposed rule,
performance liquid chromatography a tolerance for rapeseed subgroup 20A. the requirements of the Regulatory
with tandem mass spectrometry (HPLC/ The full three year freezer storage Flexibility Act (RFA) (5 U.S.C. 601 et
MS–MS)) is available to enforce the stability data (OPPTS guideline number seq.), do not apply.
tolerance expression. 860.1380) for crop field trial data are This action directly regulates growers,
The method may be requested from: needed to support tolerances. These food processors, food handlers, and food
ehiers on DSK5VPTVN1PROD with RULES
Chief, Analytical Chemistry Branch, data are required since samples from retailers, not States or tribes, nor does
Environmental Science Center, 701 crop field trials are often stored for a this action alter the relationships or
Mapes Rd., Ft. Meade, MD 20755–5350; number of years prior to analysis. distribution of power and
telephone number: (410) 305–2905; Therefore, it is a requirement to ensure responsibilities established by Congress
email address: residuemethods@ that the residues that are found multiple in the preemption provisions of FFDCA
epa.gov. years later are actually representative of section 408(n)(4). As such, the Agency
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![Federal Register / Vol. 81, No. 196 / Tuesday, October 11, 2016 / Rules and Regulations 70043
has determined that this action will not commodities in the table below. ADDRESSES: This final rule and the PDM
have a substantial direct effect on States Compliance with the tolerance levels plan are available on the Internet at
or tribal governments, on the specified below is to be determined by http://www.regulations.gov at Docket
relationship between the national measuring only mandestrobin, 2-[(2,5- Number FWS–R4–ES–2014–0054.
government and the States or tribal dimethylphenoxy)methyl]-a-methoxy- Comments and materials received, as
governments, or on the distribution of N-methylbenzeneacetamide. well as supporting documentation used
power and responsibilities among the in the preparation of this rule, will be
various levels of government or between Parts per available for public inspection by
Commodity
the Federal Government and Indian million appointment, during normal business
tribes. Thus, the Agency has determined Berry, low growing, subgroup
hours, at the Service’s Kentucky
that Executive Order 13132, entitled 13–07G, except cranberry .... 3.0 Ecological Services Field Office, 330
‘‘Federalism’’ (64 FR 43255, August 10, Fruit, small vine climbing, ex- West Broadway, Suite 265, Frankfort,
1999) and Executive Order 13175, cept fuzzy kiwifruit, subgroup KY 40601.
entitled ‘‘Consultation and Coordination 13–07F .................................. 5.0 FOR FURTHER INFORMATION CONTACT:
with Indian Tribal Governments’’ (65 FR Grape, raisin ............................. 7.0 Virgil Lee Andrews, Jr., Field
67249, November 9, 2000) do not apply Supervisor, U.S. Fish and Wildlife
to this action. In addition, this action (b) Section 18 emergency exemptions. Service, Kentucky Ecological Services
does not impose any enforceable duty or [Reserved] Field Office, 330 West Broadway, Suite
contain any unfunded mandate as (c) Tolerances with regional 265, Frankfort, KY 40601; telephone
described under Title II of the Unfunded registrations. [Reserved] (502) 695–0468. Individuals who are
Mandates Reform Act (UMRA) (2 U.S.C. (d) Indirect or inadvertent tolerances. hearing-impaired or speech-impaired
1501 et seq.). [Reserved] may call the Federal Information Relay
This action does not involve any [FR Doc. 2016–24492 Filed 10–7–16; 8:45 am] Service at (800) 877–8339 for TTY
technical standards that would require BILLING CODE 6560–50–P assistance 24 hours a day, 7 days a
Agency consideration of voluntary week.
consensus standards pursuant to section
SUPPLEMENTARY INFORMATION:
12(d) of the National Technology
Transfer and Advancement Act DEPARTMENT OF THE INTERIOR
Executive Summary
(NTTAA) (15 U.S.C. 272 note). Fish and Wildlife Service This document contains: (1) A final
VII. Congressional Review Act rule to remove Solidago albopilosa from
Pursuant to the Congressional Review 50 CFR Part 17 the Federal List of Endangered and
Act (5 U.S.C. 801 et seq.), EPA will Threatened Plants at 50 CFR 17.12(h);
[Docket No. FWS–R4–ES–2014–0054; and (2) a notice of availability of a final
submit a report containing this rule and FXES11130900000 167 FF09E42000]
other required information to the U.S. PDM plan.
Senate, the U.S. House of RIN 1018–BA46 Species addressed—Solidago
Representatives, and the Comptroller albopilosa (white-haired goldenrod) is
General of the United States prior to Endangered and Threatened Wildlife an upright, herbaceous plant with soft,
publication of the rule in the Federal and Plants; Removal of Solidago white hairs covering its leaves and
Register. This action is not a ‘‘major albopilosa (White-haired Goldenrod) stems (Andreasen and Eshbaugh 1973,
rule’’ as defined by 5 U.S.C. 804(2). From the Federal List of Endangered p. 123). The species produces clusters of
and Threatened Plants small, fragrant, yellow flowers from
List of Subjects in 40 CFR Part 180 September to November. S. albopilosa is
AGENCY: Fish and Wildlife Service, restricted to sandstone rock shelters or
Environmental protection,
Interior. rocky ledges of a highly dissected region
Administrative practice and procedure,
Agricultural commodities, Pesticides ACTION: Final rule and notice of known as the Red River Gorge in
and pests, Reporting and recordkeeping availability of final post-delisting Menifee, Powell, and Wolfe Counties,
requirements. monitoring plan. KY.
The Service listed Solidago albopilosa
Dated: September 30, 2016. SUMMARY: We, the U.S. Fish and as a threatened species under the
Jack E. Housenger, Wildlife Service (Service), are removing Endangered Species Act of 1973, as
Director, Office of Pesticide Programs. the plant Solidago albopilosa (white- amended (Act; 16 U.S.C. 1531 et seq.),
haired goldenrod) from the Federal List primarily because of its limited range
Therefore, 40 CFR chapter I is
of Endangered and Threatened Plants. and threats associated with ground
amended as follows:
This action is based on a thorough disturbance and trampling caused by
PART 180—[AMENDED] review of the best available scientific unlawful archaeological activities and
and commercial information, which recreational activities such as camping,
■ 1. The authority citation for part 180 indicates that the threats to this species hiking, and rock climbing (53 FR 11612,
continues to read as follows: have been eliminated or reduced to the April 7, 1988). Other identified threats
Authority: 21 U.S.C. 321(q), 346a and 371. point that the species no longer meets included the inadequacy of regulatory
the definition of an endangered or mechanisms and minor vegetational
■ 2. Add § 180.690 to subpart C to read threatened species under the
as follows: changes in the surrounding forest.
Endangered Species Act of 1973, as When the recovery plan for S.
ehiers on DSK5VPTVN1PROD with RULES
§ 180.690 Mandestrobin; tolerances for amended. This rule also announces the albopilosa (white-haired goldenrod)
residues. availability of a final post-delisting (Recovery Plan) was completed in 1993,
(a) General. Tolerances are monitoring (PDM) plan for white-haired the Service knew of 90 extant
established for residues of goldenrod. occurrences of S. albopilosa (Service
mandestrobin, including its metabolites DATES: This rule is effective on 1993, p. 2), containing an estimated
and degradates, in or on the November 10, 2016. 45,000 stems (each individual plant can
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Document Created: 2018-02-13 16:34:20
Document Modified: 2018-02-13 16:34:20
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule. | |
| Dates | This regulation is effective October 11, 2016. Objections and requests for hearings must be received on or before December 12, 2016, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). | |
| Contact | Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone | |
| FR Citation | 81 FR 70038 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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