80 FR 16302 - Thiram; Pesticide Tolerance
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 80, Issue 59 (March 27, 2015)
Federal Register Volume 80, Issue 59 (March 27, 2015)
| Page Range | 16302-16306 | |
| FR Document | 2015-06981 |
[Federal Register Volume 80, Number 59 (Friday, March 27, 2015)] [Rules and Regulations] [Pages 16302-16306] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-06981] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2014-0632; FRL-9924-86] Thiram; Pesticide Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This regulation establishes a tolerance for residues of thiram in or on banana. Taminco US, Inc. requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective March 27, 2015. Objections and requests for hearings must be received on or before May 26, 2015, 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-2014-0632, 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]. [[Page 16303]] 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 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 EPA's tolerance regulations at 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-2014-0632 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 May 26, 2015. 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-2014-0632, 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 Tolerance 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 4E8268) by Taminco US, Inc., Two Windsor Plaza, Suite 411, Allentown, PA 18195. The petition requested that 40 CFR 180.132 be amended by establishing a tolerance for residues of the fungicide thiram, in or on banana at 0.8 parts per million (ppm). That document referenced a summary of the petition prepared by Taminco US, Inc., the petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing. 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 thiram including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with thiram 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. Thiram is a dimethyl dithiocarbamate fungicide. Thiram has been shown to cause neurotoxicity following acute and subchronic exposures. In the acute and subchronic neurotoxicity studies submitted, neurotoxicity is characterized as lethargy, reduced and/or tail pinch response, changes in the functional-observation battery (FOB) parameters, increased hyperactivity, changes in motor activity, and increased occurrences of rearing events. No treatment-related changes were observed in brain weights or in the histopathology of the nervous system. In a non-guideline study published in the open literature, chronic feeding of thiram to rats caused neurotoxicity, with onset of ataxia in some animals 5-19 months after beginning of treatment. However, no evidence of neurotoxicity was seen following chronic exposures in mice or rats in guideline studies submitted to the Agency. The chronic toxicity profile for thiram indicates that the liver, blood, and urinary system are the target organs for this chemical in mice, rats, and dogs. There is no evidence for increased susceptibility following in utero exposures to rats or rabbits and following prenatal and postnatal exposures to rats for 2 generations. There is evidence of quantitative susceptibility in the developmental neurotoxicity (DNT) study. However, there is low concern for the increased susceptibility seen in the DNT study since the dose response is well defined with a clear no-observed-adverse-effect-level (NOAEL) and this endpoint is used for assessing the acute dietary risk for the most sensitive [[Page 16304]] population. Thiram is classified as ``not likely to be carcinogenic to humans'' based on lack of evidence for carcinogenicity in mice or rats. There are no mutagenic/genotoxic concerns with thiram. The available toxicological database for thiram suggests that this chemical has a low to moderate acute-toxicity profile. Specific information on the studies received and the nature of the adverse effects caused by thiram as well as the NOAEL and the lowest- observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document ``Thiram. Update to the Aggregate Risk Assessment to Support the Requested PHI Reduction and Increased Tolerance Request on Strawberry,'' p. 9 in docket ID number EPA-HQ-OPP-2012-0925. 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 thiram used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of February 12, 2014 (79 FR 8295) (FRL-9904- 22). C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to thiram, EPA considered exposure under the petitioned-for tolerances as well as all existing thiram tolerances in 40 CFR 180.132. EPA assessed dietary exposures from thiram 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. A partially refined probabilistic acute dietary-exposure assessment was performed using 100 percent crop treated (PCT), tolerance-level residues the highest residue found during field-trials, distributions of field trial residues, and empirical processing factors. ii. Chronic exposure. Tolerances-level residues for banana and average field trial residues for apples, peaches, and strawberries along with 100 PCT were used for the chronic dietary exposure analysis for all crops. Empirical processing factors were also used. iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that thiram does not 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 PCT information in the dietary assessment for thiram. The acute dietary assessment used 100 PCT, tolerance-level residues, the highest residue found during field-trials, distributions of field trial residues, and empirical processing factors; the chronic dietary assessment used average field trial residues along with tolerance-level residues. In addition, 100 PCT were assumed for all food commodities. Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must require pursuant to FFDCA section 408(f)(1) that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such data call-ins as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submitted no later than 5 years from the date of issuance of these tolerances. 2. Dietary exposure from drinking water. The Agency used screening- level water exposure models in the dietary exposure analysis and risk assessment for thiram in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of thiram. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm. Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI- GROW) models, the estimated drinking water concentrations (EDWCs) of thiram for acute exposures are 0.0478 parts per million (ppm) and 0.0025 ppm for chronic exposures (for non-cancer assessments) for surface water. Ground water sources were not included (for acute or chronic exposures), as the EDWCs for ground water are minimal in comparison to those for surface water. Surface water EDWCs were incorporated in DEEM-FCID into the food categories ``water, direct, all sources'' and ``water, indirect, all sources'' for the dietary assessments. 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). Thiram is not available for sale or use by homeowner applicators; therefore, there are no residential handler exposure scenarios. However, there is potential for residential post-application dermal exposure from treated golf course greens and tees. Residential exposures resulting from dermal contact with thiram-treated turf were assessed for children 6 to <11 years old, children 11 to <16 years old, and adults as described in document ``Thiram. Update to the Aggregate Risk Assessment to Support the Requested PHI Reduction and Increased Tolerance Request on Strawberry,'' p. 15 in docket ID number EPA-HQ-OPP-2012-0925. 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.'' Unlike the N-methyl carbamate pesticides, EPA has not found thiram (a dithiocarbamate) to share a common mechanism of toxicity with any other [[Page 16305]] substances, and thiram does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that thiram 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://www.epa.gov/pesticides/cumulative. 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 Food Quality Protection Act Safety Factor (FQPA 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 was no evidence of increased susceptibility following in utero exposure to rats or rabbits or following prenatal and postnatal exposures to rats. There is evidence of quantitative susceptibility in the DNT study. However, there is low concern for the enhanced susceptibility seen in the DNT study because: i. Clear NOAELs/LOAELs were established for the offspring effects. ii. The dose-response is well defined. iii. The behavioral effect of concern were observed only in females on one evaluation time period. iv. The dose/endpoint is used for acute dietary risk for the most sensitive population subgroup (females 13-49 years old). Consequently, there are no residual uncertainties for prenatal and postnatal toxicity. Consequently, there are no residual uncertainties for prenatal and postnatal toxicity. 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 thiram is complete with acceptable neurotoxicity, developmental, and reproductive toxicity studies. ii. As explained in this unit, there are no residual uncertainties for prenatal and postnatal toxicity. iii. There are no residual uncertainties identified in the exposure databases. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to thiram in drinking water. In addition, the acute dietary exposure analysis used field trial data along with the 100 PCT. The chronic dietary exposure analysis used tolerance level residues or average field residues along with the 100 PCT. In addition, washing studies were incorporated into the dietary analyses since thiram is not a systemic pesticide and will wash off during normal washing procedures. These assessments will not underestimate the exposure and risks posed by thiram. These assessments will not underestimate the exposure and risks posed by thiram. 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. The acute dietary risk estimates are not of concern to EPA (<100% aPAD) at the 95th exposure percentile for the general U.S. population and all other population subgroups. The acute dietary exposure was 62% of the aPAD for females 13-49 years old, the population subgroup with the highest percent aPAD. Therefore, the acute aggregate risk associated with the proposed uses of thiram is not of concern to EPA for the general U.S. population or any population subgroups. 2. Chronic risk. The chronic aggregate risk assessment takes into account exposure estimates from dietary consumption of thiram (food and drinking water). The chronic dietary risk estimates are not of concern to EPA (<100% cPAD) for the general U.S. population and all other population subgroups. The chronic dietary exposure was 70% of the cPAD for children 1-2 years old, the population subgroup with the highest estimated chronic dietary exposure. Therefore, the chronic aggregate risk associated with the proposed uses of thiram is not of concern to EPA for the general U.S. population or any population subgroups. 3. Short-term and intermediate-term risk. In aggregating short- and intermediate-term risk, the Agency routinely combines background chronic dietary exposure (food + water) with short/intermediate-term residential exposure (dermal only). The combined exposure may then be used to calculate an MOE for aggregate risk. Using the golfer scenario for adult males, adult females, and children >6 years old, combined with the applicable subpopulation with the greatest dietary exposure, the total short/intermediate-term food and residential aggregate MOEs are 570, 540, and 280, respectively. As these MOEs are above the target MOE of 100, the short- and intermediate-term aggregate risks are not of concern. For children <6 years old, there is no residential exposure, therefore, a short/intermediate term aggregate risk assessment is not required for this population. 4. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, thiram is not expected to pose a cancer risk to humans. 5. 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 thiram residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (colorimetric analytical method) 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 [[Page 16306]] (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 thiram in or on banana. V. Conclusion Therefore, EPA is removing the expiration/revocation date for the current tolerance for residues of thiram, in or on banana at 0.80 ppm. VI. Statutory and Executive Order Reviews This action establishes a tolerance 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 tolerance 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 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: March 19, 2015. Susan Lewis, Director, Registration Division, 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. In Sec. 180.132, the table in paragraph (a) is revised to read as follows: Sec. 180.132 Thiram; tolerances for residues. (a) * * * ------------------------------------------------------------------------ Parts per Commodity million ------------------------------------------------------------------------ Apple................................................... 7.0 Banana \1\.............................................. 0.80 Peach................................................... 7.0 Strawberry.............................................. 20 ------------------------------------------------------------------------ \1\ No U.S. registrations as of September 23, 2009. * * * * * [FR Doc. 2015-06981 Filed 3-26-15; 8:45 am] BILLING CODE 6560-50-P
![16302 Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Rules and Regulations
appropriately enforced under the 67249, November 9, 2000) do not apply and its major metabolites, trans-
Federal Insecticide, Fungicide, and to this action. In addition, this action deltamethrin, (S)-alpha-cyano-m-
Rodenticide Act (FIFRA) as use does not impose any enforceable duty or phenoxybenzyl(1R,3S)-3-(2,2-
directions on the label. contain any unfunded mandate as dibromovinyl)-2,2-
described under Title II of the Unfunded dimethylcyclopropanecarboxylate, and
VI. Statutory and Executive Order
Reviews Mandates Reform Act (UMRA) (2 U.S.C. alpha-R-deltamethrin, (R)-alpha-cyano-
1501 et seq.). m-phenoxybenzyl-(1R,3R)-3-(2,2-
This action establishes tolerances This action does not involve any dibromovinyl)-2,2-
under FFDCA section 408(d) in technical standards that would require dimethylcyclopropanecarboxylate, in or
response to a petition submitted to the Agency consideration of voluntary on the commodity.
Agency. The Office of Management and consensus standards pursuant to section * * * * *
Budget (OMB) has exempted these types 12(d) of the National Technology [FR Doc. 2015–06861 Filed 3–26–15; 8:45 am]
of actions from review under Executive Transfer and Advancement Act BILLING CODE 6560–50–P
Order 12866, entitled ‘‘Regulatory (NTTAA) (15 U.S.C. 272 note).
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this action VII. Congressional Review Act
ENVIRONMENTAL PROTECTION
has been exempted from review under Pursuant to the Congressional Review AGENCY
Executive Order 12866, this action is Act (5 U.S.C. 801 et seq.), EPA will
not subject to Executive Order 13211, submit a report containing this rule and 40 CFR Part 180
entitled ‘‘Actions Concerning other required information to the U.S.
Regulations That Significantly Affect [EPA–HQ–OPP–2014–0632; FRL–9924–86]
Senate, the U.S. House of
Energy Supply, Distribution, or Use’’ (66 Representatives, and the Comptroller Thiram; Pesticide Tolerance
FR 28355, May 22, 2001) or Executive General of the United States prior to
Order 13045, entitled ‘‘Protection of publication of the rule in the Federal AGENCY: Environmental Protection
Children from Environmental Health Register. This action is not a ‘‘major Agency (EPA).
Risks and Safety Risks’’ (62 FR 19885, rule’’ as defined by 5 U.S.C. 804(2). ACTION: Final rule.
April 23, 1997). This action does not
contain any information collections List of Subjects in 40 CFR Part 180 SUMMARY: This regulation establishes a
subject to OMB approval under the Environmental protection, tolerance for residues of thiram in or on
Paperwork Reduction Act (PRA) (44 Administrative practice and procedure, banana. Taminco US, Inc. requested this
U.S.C. 3501 et seq.), nor does it require Agricultural commodities, Pesticides tolerance under the Federal Food, Drug,
any special considerations under and pests, Reporting and recordkeeping and Cosmetic Act (FFDCA).
Executive Order 12898, entitled requirements. DATES: This regulation is effective
‘‘Federal Actions to Address March 27, 2015. Objections and requests
Dated: March 18, 2015.
Environmental Justice in Minority for hearings must be received on or
Susan Lewis,
Populations and Low-Income before May 26, 2015, and must be filed
Populations’’ (59 FR 7629, February 16, Director, Registration Division, Office of
Pesticide Programs.
in accordance with the instructions
1994). provided in 40 CFR part 178 (see also
Since tolerances and exemptions that Therefore, 40 CFR chapter I is Unit I.C. of the SUPPLEMENTARY
are established on the basis of a petition amended as follows: INFORMATION).
under FFDCA section 408(d), such as
the tolerance in this final rule, do not PART 180—[AMENDED] ADDRESSES: The docket for this action,
require the issuance of a proposed rule, identified by docket identification (ID)
the requirements of the Regulatory ■ 1. The authority citation for part 180 number EPA–HQ–OPP–2014–0632, is
Flexibility Act (RFA) (5 U.S.C. 601 et continues to read as follows: available at http://www.regulations.gov
seq.), do not apply. Authority: 21 U.S.C. 321(q), 346a and 371. or at the Office of Pesticide Programs
This action directly regulates growers, ■ 2. In § 180.435, paragraph (a)(2) is Regulatory Public Docket (OPP Docket)
food processors, food handlers, and food revised to read as: in the Environmental Protection Agency
retailers, not States or tribes, nor does Docket Center (EPA/DC), West William
this action alter the relationships or § 180.435 Deltamethrin; tolerances for Jefferson Clinton Bldg., Rm. 3334, 1301
distribution of power and residues. Constitution Ave. NW., Washington, DC
responsibilities established by Congress (a) General. * * * 20460–0001. The Public Reading Room
in the preemption provisions of FFDCA * * * * * is open from 8:30 a.m. to 4:30 p.m.,
section 408(n)(4). As such, the Agency (2) A tolerance of 0.05 ppm is Monday through Friday, excluding legal
has determined that this action will not established for residues of the holidays. The telephone number for the
have a substantial direct effect on States insecticide deltamethrin, including its Public Reading Room is (202) 566–1744,
or tribal governments, on the metabolites and degradates, in or on all and the telephone number for the OPP
relationship between the national food/feed items (other than those Docket is (703) 305–5805. Please review
government and the States or tribal covered by a higher tolerance as a result the visitor instructions and additional
governments, or on the distribution of of use on growing crops) when information about the docket available
power and responsibilities among the deltamethrin is used in food/feed at http://www.epa.gov/dockets.
asabaliauskas on DSK5VPTVN1PROD with RULES
various levels of government or between handling establishments or as a wide- FOR FURTHER INFORMATION CONTACT:
the Federal Government and Indian area mosquito adulticide. Compliance Susan Lewis, Registration Division
tribes. Thus, the Agency has determined with the tolerance levels specified is to (7505P), Office of Pesticide Programs,
that Executive Order 13132, entitled be determined by measuring only Environmental Protection Agency, 1200
‘‘Federalism’’ (64 FR 43255, August 10, deltamethrin, (1R,3R)-3-(2,2- Pennsylvania Ave. NW., Washington,
1999) and Executive Order 13175, dibromovinyl)-2,2- DC 20460–0001; main telephone
entitled ‘‘Consultation and Coordination dimethylcyclopropanecarboxylic acid number: (703) 305–7090; email address:
with Indian Tribal Governments’’ (65 FR (S)-alpha-cyano-3-phenoxybenzyl ester, RDFRNotices@epa.gov.
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![16306 Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Rules and Regulations
(MRLs) established by the Codex this action alter the relationships or § 180.132 Thiram; tolerances for residues.
Alimentarius Commission (Codex), as distribution of power and (a) * * *
required by FFDCA section 408(b)(4). responsibilities established by Congress
The Codex Alimentarius is a joint in the preemption provisions of FFDCA Commodity Parts per million
United Nations Food and Agriculture section 408(n)(4). As such, the Agency
Organization/World Health has determined that this action will not Apple ................................... 7.0
Organization food standards program, have a substantial direct effect on States Banana 1 ............................. 0.80
Peach .................................. 7.0
and it is recognized as an international or tribal governments, on the Strawberry .......................... 20
food safety standards-setting relationship between the national
organization in trade agreements to government and the States or tribal 1 No U.S. registrations as of September 23,
which the United States is a party. EPA governments, or on the distribution of 2009.
may establish a tolerance that is power and responsibilities among the * * * * *
different from a Codex MRL; however, various levels of government or between [FR Doc. 2015–06981 Filed 3–26–15; 8:45 am]
FFDCA section 408(b)(4) requires that the Federal Government and Indian BILLING CODE 6560–50–P
EPA explain the reasons for departing tribes. Thus, the Agency has determined
from the Codex level. The Codex has not that Executive Order 13132, entitled
established a MRL for thiram in or on ‘‘Federalism’’ (64 FR 43255, August 10, DEPARTMENT OF COMMERCE
banana. 1999) and Executive Order 13175,
V. Conclusion entitled ‘‘Consultation and Coordination National Oceanic and Atmospheric
with Indian Tribal Governments’’ (65 FR Administration
Therefore, EPA is removing the 67249, November 9, 2000) do not apply
expiration/revocation date for the to this action. In addition, this action 50 CFR Part 622
current tolerance for residues of thiram, does not impose any enforceable duty or
in or on banana at 0.80 ppm. contain any unfunded mandate as [Docket No. 130403320–4891–02]
VI. Statutory and Executive Order described under Title II of the Unfunded RIN 0648–XD828
Reviews Mandates Reform Act (UMRA) (2 U.S.C.
This action establishes a tolerance 1501 et seq.). Fisheries of the Caribbean, Gulf of
under FFDCA section 408(d) in This action does not involve any Mexico, and South Atlantic; Snapper-
response to a petition submitted to the technical standards that would require Grouper Resources of the South
Agency. The Office of Management and Agency consideration of voluntary Atlantic; 2015–2016 Recreational
Budget (OMB) has exempted these types consensus standards pursuant to section Fishing Season for Black Sea Bass
of actions from review under Executive 12(d) of the National Technology
Transfer and Advancement Act AGENCY: National Marine Fisheries
Order 12866, entitled ‘‘Regulatory Service (NMFS), National Oceanic and
Planning and Review’’ (58 FR 51735, (NTTAA) (15 U.S.C. 272 note).
Atmospheric Administration (NOAA),
October 4, 1993). Because this action VII. Congressional Review Act Commerce.
has been exempted from review under
Pursuant to the Congressional Review ACTION: Temporary rule; recreational
Executive Order 12866, this action is
Act (5 U.S.C. 801 et seq.), EPA will season length.
not subject to Executive Order 13211,
entitled ‘‘Actions Concerning submit a report containing this rule and
other required information to the U.S. SUMMARY: NMFS announces that the
Regulations That Significantly Affect length of the recreational season for
Energy Supply, Distribution, or Use’’ (66 Senate, the U.S. House of
Representatives, and the Comptroller black sea bass in the exclusive economic
FR 28355, May 22, 2001) or Executive zone (EEZ) of the South Atlantic will
Order 13045, entitled ‘‘Protection of General of the United States prior to
publication of the rule in the Federal extend throughout the fishing year.
Children from Environmental Health Announcing the length of recreational
Risks and Safety Risks’’ (62 FR 19885, Register. This action is not a ‘‘major
rule’’ as defined by 5 U.S.C. 804(2). season for black sea bass is one of the
April 23, 1997). This action does not accountability measures (AMs) for the
contain any information collections List of Subjects in 40 CFR Part 180 recreational sector. This announcement
subject to OMB approval under the allows recreational fishermen to
Paperwork Reduction Act (PRA) (44 Environmental protection,
Administrative practice and procedure, maximize their opportunity to harvest
U.S.C. 3501 et seq.), nor does it require the recreational annual catch limit
any special considerations under Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping (ACL) for black sea bass during the
Executive Order 12898, entitled fishing season while managing harvest
‘‘Federal Actions to Address requirements.
to protect the black sea bass resource.
Environmental Justice in Minority Dated: March 19, 2015.
DATES: This rule is effective from 12:01
Populations and Low-Income Susan Lewis,
a.m., local time, April 1, 2015, until
Populations’’ (59 FR 7629, February 16, Director, Registration Division, Office of 12:01 a.m., local time, April 1, 2016,
1994). Pesticide Programs.
unless changed by subsequent
Since tolerances and exemptions that
Therefore, 40 CFR chapter I is notification in the Federal Register.
are established on the basis of a petition
amended as follows: FOR FURTHER INFORMATION CONTACT:
under FFDCA section 408(d), such as
asabaliauskas on DSK5VPTVN1PROD with RULES
the tolerance in this final rule, do not Nikhil Mehta, NMFS Southeast Regional
PART 180—[AMENDED] Office, telephone: 727–824–5305, email:
require the issuance of a proposed rule,
the requirements of the Regulatory nikhil.mehta@noaa.gov.
■ 1. The authority citation for part 180
Flexibility Act (RFA) (5 U.S.C. 601 et continues to read as follows: SUPPLEMENTARY INFORMATION: The
seq.), do not apply. snapper-grouper fishery includes black
Authority: 21 U.S.C. 321(q), 346a and 371.
This action directly regulates growers, sea bass in the South Atlantic and is
food processors, food handlers, and food ■ 2. In § 180.132, the table in paragraph managed under the Fishery
retailers, not States or tribes, nor does (a) is revised to read as follows: Management Plan for the Snapper-
VerDate Sep<11>2014 16:44 Mar 26, 2015 Jkt 235001 PO 00000 Frm 00056 Fmt 4700 Sfmt 4700 E:\FR\FM\27MRR1.SGM 27MRR1](https://thefederalregister.org/doc/80_FR_16361/page/5.svg)
Document Created: 2015-12-18 11:36:22
Document Modified: 2015-12-18 11:36:22
| 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 March 27, 2015. Objections and requests for hearings must be received on or before May 26, 2015, 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 | 80 FR 16302 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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