82 FR 56735 - Boscalid; Pesticide Tolerance
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 82, Issue 229 (November 30, 2017)
Federal Register Volume 82, Issue 229 (November 30, 2017)
| Page Range | 56735-56739 | |
| FR Document | 2017-25832 |
[Federal Register Volume 82, Number 229 (Thursday, November 30, 2017)] [Rules and Regulations] [Pages 56735-56739] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-25832] ======================================================================= ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2016-0600; FRL-9968-95] Boscalid; Pesticide Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This regulation establishes a tolerance for residues of boscalid in or on vegetable, legume, edible-podded subgroup 6A. BASF Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective November 30, 2017. Objections and requests for hearings must be received on or before January 29, 2018, 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-2016-0600, 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: Michael L. Goodis, 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 provides a guide to help readers [[Page 56736]] 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-2016-0600 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 January 29, 2018. 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-2016-0600, 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 July 26, 2017 (82 FR 34664) (FRL-9963- 50), 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 6E8503) by BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research Triangle Park, NC 27709. The petition requested that 40 CFR 180.589 be amended by increasing the existing tolerance for residues of the fungicide boscalid, 3-pyridinecarboxamide,2-chloro-N-(4'-chloro[1,1'- biphenyl]-2-yl), in or on vegetable, legume, edible podded subgroup 6A at from 1.6 parts per million (ppm) to 5.0 ppm. This document referenced a summary of the petition prepared by BASF Corporation, the registrant, 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 boscalid including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with boscalid follows. A. Toxicological Profile and Points of Departure In the Federal Register of March 18, 2015 (80 FR 14009) (FRL-9921- 01), EPA published a final rule concerning tolerances for residues of boscalid. The preamble to that rule contains a summary of the toxicological profile and endpoints for assessing risk that EPA is incorporating by reference here, as those elements have not changed. B. Exposure Assessment The petitioned-for tolerance increase is intended to facilitate imports of commodities in subgroup 6A, rather than accommodate residues resulting from changes in domestic uses; therefore, the only potential impact on the Agency's previous exposure assessment is through consumption of imported food containing boscalid residues. To assess the new dietary exposure levels, EPA considered exposure under the petitioned-for tolerances as well as all existing boscalid tolerances in 40 CFR 180.589. EPA assessed dietary exposures from boscalid in food as follows: 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 boscalid; therefore, a quantitative acute dietary exposure assessment is unnecessary. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used food consumption information from the 2003-2008 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 and used some percent crop treated (PCT) information as described below. Cancer. As discussed in Unit III.A. of the March 18, 2015 Federal Register, EPA has concluded that the chronic endpoint will be protective of potential cancer effects. EPA's estimate of chronic exposure as described above is relied upon to evaluate whether any exposure could exceed the chronic population [[Page 56737]] adjusted doses (cPAD) and thus pose a cancer risk. Anticipated residue and percent crop treated (PCT) information. Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if: Condition a: The data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain the pesticide residue. Condition b: The exposure estimate does not underestimate exposure for any significant subpopulation group. Condition c: Data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by FFDCA section 408(b)(2)(F), EPA may require registrants to submit data on PCT. The Agency used the following chronic PCT for existing uses: Almonds 45%; apples 15%; apricots 30%; green beans 5%; blueberries 35%; broccoli 2.5%; brussels sprouts 2.5%; cabbage 5%; caneberries 45%; cantaloupes 5%; carrots 20%; cauliflower 2.5%; celery 10%; cherries 50%; chicory 5%; cucumbers 5%; dry beans/dry peas 5%; garlic 5%; grapes 30%; hazelnuts 5%; lemons 2.5%; lettuce 30%; nectarines 15%; onions 25%; oranges 1%; peaches 25%; peanuts 1%; pears 20%; green peas 1%; peppers 2.5%; pistachios 30%; plums/prunes 5%; potatoes 25%; pumpkins 10%; squash 5%; strawberries 60%; sweet corn 1%; tomatoes 2.5%; walnuts 5%; and watermelons 25%. In most cases, EPA uses available data from the United States Department of Agriculture/National Agricultural Statistics Service (USDA/NASS), proprietary market surveys, and the National Pesticide Use Database for the chemical/crop combination for the most recent six years. EPA uses an average PCT for chronic dietary risk analysis and a maximum PCT for acute dietary risk analysis. The average PCT figure for each existing use is derived by combining available public and private market survey data for that use, averaging across all observations, and rounding to the nearest 5%, except for those situations in which the average PCT is less than 2.5%. The maximum PCT figure is the highest observed maximum value reported within the most recent 6 years of available public and private market survey data for the existing use and rounded up to the nearest multiple of 5%, except for situations in which the maximum PCT is less than 2.5%. In cases where the estimated value is less than 2.5% but greater than 1%, the average and maximum PCT used are 2.5%. If the estimated value is less than 1%, 1% is used as the average PCT and 2.5% is used as the maximum PCT. The Agency believes that the three conditions discussed above have been met. With respect to Condition a, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions b and c, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available reliable information on the regional consumption of food to which may be applied in a particular area. Because this tolerance increase does not impact drinking water or residential exposures, the drinking water and non-dietary exposure discussions from the March 18, 2015 Federal Register continue to be valid. Those assumptions were used to assess aggregate exposure for this tolerance action, and EPA incorporates them here by reference. Moreover, the current action does not impact the Agency's previous conclusions on cumulative effects; therefore, EPA incorporates the cumulative effects section from the March 18, 2015 Federal Register as well. C. 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 (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. Conclusion. The finding for the FQPA SF in the March 18, 2015 rule remains valid for this action. Therefore, for the reasons stated in the March 18, 2015 Federal Register, 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 for all scenarios, except residential handler inhalation exposure. D. 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, boscalid 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 boscalid from food and water will utilize 12% of the cPAD for the general U.S. population and 27% of the cPAD for all infants (less than 1 year 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 residues of boscalid is not expected. 3. Short-term and intermediate-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). Boscalid is currently registered for uses that could result in short-term residential exposure, which the Agency [[Page 56738]] previously assessed and discussed in the March 18, 2015 Federal Register. The preamble to the March 18, 2015 rule concluded that there were no short-term risks of concern. Because the chronic dietary exposure has only increased potential chronic risk 1% of the cPAD to 27% of the cPAD, which is still well below EPA's level of concern for chronic risk, and there is no change to the domestic use pattern to impact the non-occupational exposure, EPA concludes that the increase in dietary exposure will not meaningfully impact the aggregate risk and the short-term risk will continue to be below the Agency's levels 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). An intermediate-term adverse effect was identified; however, boscalid is not registered for any use patterns that would result in intermediate-term residential exposure. Intermediate-term risk is assessed based on intermediate-term residential exposure plus chronic dietary exposure. Because there is no intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess intermediate-term risk), no further assessment of intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediate-term risk for boscalid. 5. Aggregate cancer risk for U.S. population. As discussed in Unit III.A. of the March 18, 2015 Federal Register, EPA has concluded that the cPAD is protective of possible cancer effects. Given the results of the chronic risk assessment, cancer risk resulting from exposure to boscalid is not of concern. 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 boscalid residues. IV. Other Considerations A. Analytical Enforcement Methodology An adequate gas chromatography/mass spectrometric detection (GC/MS) method (Method D0008) using selected ion monitoring (SIM) of major ions is available for enforcing boscalid tolerances in plant commodities, and an adequate GC/electron capture detection method (ECD) (Method DFG S19) is available for enforcing the tolerances in livestock commodities. The validated limit of quantitation (LOQ) for boscalid residues in most plant matrices is 0.05 ppm. These methods have been found adequate by the Analytical Chemistry Branch (ACB) of BEAD. Residues of boscalid and its metabolite M510F01 were not adequately recovered using the multiresidue methods. 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 established MRLs for boscalid in or on vegetable, legume, edible-podded subgroup 6A at 3.0 ppm. These MRLs are different than the tolerances established for boscalid in the United States. The registrant has petitioned the EPA to increase the existing tolerance level for edible-podded legume vegetable subgroup 6A from 1.6 ppm to 5.0 ppm in order to harmonize with MRL established by the European Union of 5.0 ppm. This is not anticipated to cause a trade irritant since the CODEX MRL will be lower than the U.S. tolerance, and CODEX countries will still be able to export to the U.S. For these reasons, EPA has determined it is appropriate to amend the tolerance for residues of boscalid on edible podded legume vegetable subgroup 6A as petitioned from 1.6 ppm to 5.0 ppm. V. Conclusion Therefore, a tolerance is established for residues of boscalid, boscalid, 3-pyridinecarboxamide,2-chloro-N-(4'-chloro[1,1'-biphenyl]-2- yl), in or on vegetable, legume, edible podded subgroup 6A at 5.0 ppm. VI. Statutory and Executive Order Reviews This action amends 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), Executive Order 13045, entitled ``Protection of Children from Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997), or Executive Order 13771, entitled ``Reducing Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3, 2017). 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, [[Page 56739]] 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: October 5, 2017. Daniel Kenny, Acting 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. 180.589, revise the entry for ``Vegetable, legume, edible podded subgroup 6A'' in the table in paragraph (a)(1) to read as follows: Sec. 180.589 Boscalid; tolerances for residues. (a) * * * (1) * * * ------------------------------------------------------------------------ Parts per Commodity million ------------------------------------------------------------------------ * * * * * Vegetable, legume, edible podded subgroup 6A................ 5.0 * * * * * ------------------------------------------------------------------------ * * * * * [FR Doc. 2017-25832 Filed 11-29-17; 8:45 am] BILLING CODE 6560-50-P
![Federal Register / Vol. 82, No. 229 / Thursday, November 30, 2017 / Rules and Regulations 56735
predicting that ‘‘[t]he parties almost The Judges thus conclude that the ENVIRONMENTAL PROTECTION
certainly will not agree on the value of Sirius XM Premier package is not a AGENCY
such services.’’ SoundExchange Motion service offered for a separate charge.
for Rehearing at 7 (Dec. 18, 2007) Consequently any revenues Sirius XM 40 CFR Part 180
(emphasis added). In response, Sirius excluded from its Gross Revenues [EPA–HQ–OPP–2016–0600; FRL–9968–95]
XM asserted that SoundExchange royalty base attributable to the
offered nothing but ‘‘speculation’’ that incremental Upcharge for the channels Boscalid; Pesticide Tolerance
Sirius XM ‘‘will not properly recognize in the Premier package were improper.
revenues for the provision of data AGENCY: Environmental Protection
services . . . .’’ Response . . . to Conclusion Agency (EPA).
SoundExchange Motion for Rehearing at ACTION: Final rule.
10 n. 8 (Jan. 4, 2008). Based on the foregoing findings and
Although the Judges styled their reasoning, the Judges answer the District SUMMARY: This regulation establishes a
decision as an ‘‘Order Denying Motion Court by concluding that Sirius XM tolerance for residues of boscalid in or
for Rehearing,’’ they in fact modified properly interpreted the revenue on vegetable, legume, edible-podded
their Initial Determination to clarify that exclusion to apply to pre-‘72 sound subgroup 6A. BASF Corporation
only data services offered for a ‘‘separate recordings. Given the limitations on the requested these tolerances under the
charge’’ could be excluded from the Judges’ jurisdiction, they defer to the Federal Food, Drug, and Cosmetic Act
revenue base. The Judges accomplished District Court to determine whether (FFDCA).
this by adding the ‘‘separate charge’’ Sirius XM developed a consistent, DATES: This regulation is effective
language that they had included in the transparent, reasonable methodology for November 30, 2017. Objections and
paragraph (3)(vi)(B) exclusion, the valuing those exclusions. The Judges requests for hearings must be received
language on which Sirius XM relies now also conclude that Sirius XM was on or before January 29, 2018, and must
to justify its single, bundled charge for incorrect to claim a revenue exclusion be filed in accordance with the
its Premier package (i.e., Basic + based upon its Premier package instructions provided in 40 CFR part
additional channels). Citing that upcharge, as that Premier package was 178 (see also Unit I.C. of the
language in paragraph (3)(vi)(B) of the not a service offered for a separate SUPPLEMENTARY INFORMATION).
Gross Revenues definition, the Judges charge. The Judges’ responses to the ADDRESSES: The docket for this action,
stated that ‘‘to avoid any doubt as might
District Court are based upon that identified by docket identification (ID)
be suggested by SoundExchange’s
reasoning. number EPA–HQ–OPP–2016–0600, is
arguments, we hereby clarify that
subsection (3)(vi)(A) of the definition of The Judges issued the Amended available at http://www.regulations.gov
Gross Revenues at § 382.11 Definitions, Decision to the parties in interest on or at the Office of Pesticide Programs
dealing with data services also does not September 11, 2017. This published Regulatory Public Docket (OPP Docket)
contemplate an exclusion of revenues Amended Decision redacts confidential in the Environmental Protection Agency
from such data services, where such information that is subject to a Docket Center (EPA/DC), West William
data services are not offered for a protective order in the proceeding. The Jefferson Clinton Bldg., Rm. 3334, 1301
separate charge from the basic Constitution Ave. NW., Washington, DC
Register of Copyrights reviewed this
subscription product’s revenues. . . . 20460–0001. The Public Reading Room
ruling and found no legal error.
The phrase ‘offered for a separate is open from 8:30 a.m. to 4:30 p.m.,
So ordered. Monday through Friday, excluding legal
charge’ will be added to the regulatory
language of subsection (3)(vi)(A) . . . .’’ Dated: November 8, 2017. holidays. The telephone number for the
Rehearing Order at 4–5 and n.5. Thus, Suzanne M. Barnett, Public Reading Room is (202) 566–1744,
the SDARS I Judges clearly understood and the telephone number for the OPP
Chief Copyright Royalty Judge.
that a failure by Sirius XM to set Docket is (703) 305–5805. Please review
Jesse M. Feder, the visitor instructions and additional
separate charges for bundled services
Copyright Royalty Judge. information about the docket available
that included services both in the
royalty base and outside the royalty base David R. Strickler, at http://www.epa.gov/dockets.
would be contrary to the regulatory Copyright Royalty Judge. FOR FURTHER INFORMATION CONTACT:
scheme, rendering the royalty base Michael L. Goodis, Registration Division
Approved by:
indeterminate. (7505P), Office of Pesticide Programs,
Carla D. Hayden, Environmental Protection Agency, 1200
Consistent with the Judges’ reliance
on the ‘‘separate charge’’ language in the Librarian of Congress. Pennsylvania Ave. NW., Washington,
paragraph (3)(vi)(B) exclusion to clarify [FR Doc. 2017–25816 Filed 11–29–17; 8:45 am] DC 20460–0001; main telephone
and amend the paragraph (3)(vi)(A) BILLING CODE 1410–72–P number: (703) 305–7090; email address:
exclusion, the Judges now conclude that RDFRNotices@epa.gov.
Sirius XM’s combined charge for the SUPPLEMENTARY INFORMATION:
Premier package is inconsistent with the
plain meaning of the paragraph I. General Information
(3)(vi)(B) exclusion and with the A. Does this action apply to me?
purpose of the ‘‘separate charge’’
You may be potentially affected by
requirement, viz., to clearly distinguish
sradovich on DSK3GMQ082PROD with RULES
dispute had always integrated pre-‘72 recordings this action if you are an agricultural
between revenue included in the royalty with other recordings across its channel lineup for producer, food manufacturer, or
base and revenue excluded from the a single Basic subscription price. Thus, it would be
pesticide manufacturer. The following
royalty base.41 impractical and unreasonable to require Sirius XM
to parse out a ‘‘separate charge’’ for pre-‘72 list of North American Industrial
41 By contrast, the absence of a ‘‘separate charge’’ recordings. Rather, Sirius XM attempted to fashion Classification System (NAICS) codes is
requirement for pre-‘72 sound recordings was a reasonable alternative approach to estimating the not intended to be exhaustive, but rather
reasonable. The Sirius XM business model without pre-‘72 revenue exclusion [REDACTED]. provides a guide to help readers
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determine whether this document delivery of boxed information, please and to make a determination on
applies to them. Potentially affected follow the instructions at http:// aggregate exposure for boscalid
entities may include: www.epa.gov/dockets/contacts.html. including exposure resulting from the
• Crop production (NAICS code 111). Additional instructions on tolerances established by this action.
• Animal production (NAICS code commenting or visiting the docket, EPA’s assessment of exposures and risks
112). along with more information about associated with boscalid follows.
• Food manufacturing (NAICS code dockets generally, is available at http://
311). www.epa.gov/dockets. A. Toxicological Profile and Points of
• Pesticide manufacturing (NAICS Departure
code 32532). II. Summary of Petitioned-For
Tolerance In the Federal Register of March 18,
B. How can I get electronic access to 2015 (80 FR 14009) (FRL–9921–01),
In the Federal Register of July 26, EPA published a final rule concerning
other related information? 2017 (82 FR 34664) (FRL–9963–50), tolerances for residues of boscalid. The
You may access a frequently updated EPA issued a document pursuant to preamble to that rule contains a
electronic version of EPA’s tolerance FFDCA section 408(d)(3), 21 U.S.C. summary of the toxicological profile and
regulations at 40 CFR part 180 through 346a(d)(3), announcing the filing of a endpoints for assessing risk that EPA is
the Government Printing Office’s e-CFR pesticide petition (PP 6E8503) by BASF incorporating by reference here, as those
site at http://www.ecfr.gov/cgi-bin/text- Corporation, 26 Davis Drive, P.O. Box elements have not changed.
idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 13528, Research Triangle Park, NC
40tab_02.tpl. 27709. The petition requested that 40 B. Exposure Assessment
CFR 180.589 be amended by increasing The petitioned-for tolerance increase
C. How can I file an objection or hearing the existing tolerance for residues of the
request? is intended to facilitate imports of
fungicide boscalid, 3- commodities in subgroup 6A, rather
Under FFDCA section 408(g), 21 pyridinecarboxamide,2-chloro-N-(4′- than accommodate residues resulting
U.S.C. 346a, any person may file an chloro[1,1′-biphenyl]-2-yl), in or on from changes in domestic uses;
objection to any aspect of this regulation vegetable, legume, edible podded therefore, the only potential impact on
and may also request a hearing on those subgroup 6A at from 1.6 parts per
the Agency’s previous exposure
objections. You must file your objection million (ppm) to 5.0 ppm. This
assessment is through consumption of
or request a hearing on this regulation document referenced a summary of the
imported food containing boscalid
in accordance with the instructions petition prepared by BASF Corporation,
residues. To assess the new dietary
provided in 40 CFR part 178. To ensure the registrant, which is available in the
exposure levels, EPA considered
proper receipt by EPA, you must docket, http://www.regulations.gov.
exposure under the petitioned-for
identify docket ID number EPA–HQ– There were no comments received in
tolerances as well as all existing
OPP–2016–0600 in the subject line on response to the notice of filing.
boscalid tolerances in 40 CFR 180.589.
the first page of your submission. All
III. Aggregate Risk Assessment and EPA assessed dietary exposures from
objections and requests for a hearing
Determination of Safety boscalid in food as follows:
must be in writing, and must be
received by the Hearing Clerk on or Section 408(b)(2)(A)(i) of FFDCA Acute exposure. Quantitative acute
before January 29, 2018. Addresses for allows EPA to establish a tolerance (the dietary exposure and risk assessments
mail and hand delivery of objections legal limit for a pesticide chemical are performed for a food-use pesticide,
and hearing requests are provided in 40 residue in or on a food) only if EPA if a toxicological study has indicated the
CFR 178.25(b). determines that the tolerance is ‘‘safe.’’ possibility of an effect of concern
In addition to filing an objection or Section 408(b)(2)(A)(ii) of FFDCA occurring as a result of a 1-day or single
hearing request with the Hearing Clerk defines ‘‘safe’’ to mean that ‘‘there is a exposure. No such effects were
as described in 40 CFR part 178, please reasonable certainty that no harm will identified in the toxicological studies
submit a copy of the filing (excluding result from aggregate exposure to the for boscalid; therefore, a quantitative
any Confidential Business Information pesticide chemical residue, including acute dietary exposure assessment is
(CBI)) for inclusion in the public docket. all anticipated dietary exposures and all unnecessary.
Information not marked confidential other exposures for which there is Chronic exposure. In conducting the
pursuant to 40 CFR part 2 may be reliable information.’’ This includes chronic dietary exposure assessment
disclosed publicly by EPA without prior exposure through drinking water and in EPA used food consumption
notice. Submit the non-CBI copy of your residential settings, but does not include information from the 2003–2008 food
objection or hearing request, identified occupational exposure. Section consumption data from the U.S.
by docket ID number EPA–HQ–OPP– 408(b)(2)(C) of FFDCA requires EPA to Department of Agriculture’s (USDA’s)
2016–0600, by one of the following give special consideration to exposure National Health and Nutrition
methods: of infants and children to the pesticide Examination Survey, What We Eat in
• Federal eRulemaking Portal: http:// chemical residue in establishing a America, (NHANES/WWEIA). As to
www.regulations.gov. Follow the online tolerance and to ‘‘ensure that there is a residue levels in food, EPA assumed
instructions for submitting comments. reasonable certainty that no harm will tolerance-level residues and used some
Do not submit electronically any result to infants and children from percent crop treated (PCT) information
information you consider to be CBI or aggregate exposure to the pesticide as described below.
other information whose disclosure is chemical residue. . . .’’ Cancer. As discussed in Unit III.A. of
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restricted by statute. Consistent with FFDCA section the March 18, 2015 Federal Register,
• Mail: OPP Docket, Environmental 408(b)(2)(D), and the factors specified in EPA has concluded that the chronic
Protection Agency Docket Center (EPA/ FFDCA section 408(b)(2)(D), EPA has endpoint will be protective of potential
DC), (28221T), 1200 Pennsylvania Ave. reviewed the available scientific data cancer effects. EPA’s estimate of chronic
NW., Washington, DC 20460–0001. and other relevant information in exposure as described above is relied
• Hand Delivery: To make special support of this action. EPA has upon to evaluate whether any exposure
arrangements for hand delivery or sufficient data to assess the hazards of could exceed the chronic population
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![56738 Federal Register / Vol. 82, No. 229 / Thursday, November 30, 2017 / Rules and Regulations
previously assessed and discussed in available for enforcing the tolerances in chloro[1,1′-biphenyl]-2-yl), in or on
the March 18, 2015 Federal Register. livestock commodities. The validated vegetable, legume, edible podded
The preamble to the March 18, 2015 limit of quantitation (LOQ) for boscalid subgroup 6A at 5.0 ppm.
rule concluded that there were no short- residues in most plant matrices is 0.05
VI. Statutory and Executive Order
term risks of concern. Because the ppm. These methods have been found
Reviews
chronic dietary exposure has only adequate by the Analytical Chemistry
increased potential chronic risk 1% of Branch (ACB) of BEAD. Residues of This action amends a tolerance under
the cPAD to 27% of the cPAD, which is boscalid and its metabolite M510F01 FFDCA section 408(d) in response to a
still well below EPA’s level of concern were not adequately recovered using the petition submitted to the Agency. The
for chronic risk, and there is no change multiresidue methods. Office of Management and Budget
to the domestic use pattern to impact The method may be requested from: (OMB) has exempted these types of
the non-occupational exposure, EPA Chief, Analytical Chemistry Branch, actions from review under Executive
concludes that the increase in dietary Environmental Science Center, 701 Order 12866, entitled ‘‘Regulatory
exposure will not meaningfully impact Mapes Rd., Ft. Meade, MD 20755–5350; Planning and Review’’ (58 FR 51735,
the aggregate risk and the short-term telephone number: (410) 305–2905; October 4, 1993). Because this action
risk will continue to be below the email address: residuemethods@ has been exempted from review under
Agency’s levels of concern. epa.gov. Executive Order 12866, this action is
4. Intermediate-term risk. not subject to Executive Order 13211,
B. International Residue Limits entitled ‘‘Actions Concerning
Intermediate-term aggregate exposure
takes into account intermediate-term In making its tolerance decisions, EPA Regulations That Significantly Affect
residential exposure plus chronic seeks to harmonize U.S. tolerances with Energy Supply, Distribution, or Use’’ (66
exposure to food and water (considered international standards whenever FR 28355, May 22, 2001), Executive
to be a background exposure level). possible, consistent with U.S. food Order 13045, entitled ‘‘Protection of
An intermediate-term adverse effect safety standards and agricultural Children from Environmental Health
was identified; however, boscalid is not practices. EPA considers the Risks and Safety Risks’’ (62 FR 19885,
registered for any use patterns that international maximum residue limits April 23, 1997), or Executive Order
would result in intermediate-term (MRLs) established by the Codex 13771, entitled ‘‘Reducing Regulations
residential exposure. Intermediate-term Alimentarius Commission (Codex), as and Controlling Regulatory Costs’’ (82
risk is assessed based on intermediate- required by FFDCA section 408(b)(4). FR 9339, February 3, 2017). This action
term residential exposure plus chronic The Codex Alimentarius is a joint does not contain any information
dietary exposure. Because there is no United Nations Food and Agriculture collections subject to OMB approval
intermediate-term residential exposure Organization/World Health under the Paperwork Reduction Act
and chronic dietary exposure has Organization food standards program, (PRA) (44 U.S.C. 3501 et seq.), nor does
already been assessed under the and it is recognized as an international it require any special considerations
appropriately protective cPAD (which is food safety standards-setting under Executive Order 12898, entitled
at least as protective as the POD used to organization in trade agreements to ‘‘Federal Actions to Address
which the United States is a party. EPA Environmental Justice in Minority
assess intermediate-term risk), no
may establish a tolerance that is Populations and Low-Income
further assessment of intermediate-term
different from a Codex MRL; however, Populations’’ (59 FR 7629, February 16,
risk is necessary, and EPA relies on the
FFDCA section 408(b)(4) requires that 1994).
chronic dietary risk assessment for Since tolerances and exemptions that
evaluating intermediate-term risk for EPA explain the reasons for departing
from the Codex level. are established on the basis of a petition
boscalid. under FFDCA section 408(d), such as
The Codex has established MRLs for
5. Aggregate cancer risk for U.S. the tolerance in this final rule, do not
boscalid in or on vegetable, legume,
population. As discussed in Unit III.A. require the issuance of a proposed rule,
edible-podded subgroup 6A at 3.0 ppm.
of the March 18, 2015 Federal Register, the requirements of the Regulatory
These MRLs are different than the
EPA has concluded that the cPAD is Flexibility Act (RFA) (5 U.S.C. 601 et
tolerances established for boscalid in
protective of possible cancer effects. seq.), do not apply.
the United States. The registrant has
Given the results of the chronic risk This action directly regulates growers,
petitioned the EPA to increase the
assessment, cancer risk resulting from food processors, food handlers, and food
existing tolerance level for edible-
exposure to boscalid is not of concern. retailers, not States or tribes, nor does
6. Determination of safety. Based on podded legume vegetable subgroup 6A
from 1.6 ppm to 5.0 ppm in order to this action alter the relationships or
these risk assessments, EPA concludes distribution of power and
that there is a reasonable certainty that harmonize with MRL established by the
European Union of 5.0 ppm. This is not responsibilities established by Congress
no harm will result to the general in the preemption provisions of FFDCA
population or to infants and children anticipated to cause a trade irritant
since the CODEX MRL will be lower section 408(n)(4). As such, the Agency
from aggregate exposure to boscalid has determined that this action will not
residues. than the U.S. tolerance, and CODEX
countries will still be able to export to have a substantial direct effect on States
IV. Other Considerations the U.S. For these reasons, EPA has or tribal governments, on the
determined it is appropriate to amend relationship between the national
A. Analytical Enforcement Methodology government and the States or tribal
the tolerance for residues of boscalid on
An adequate gas chromatography/ edible podded legume vegetable governments, or on the distribution of
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mass spectrometric detection (GC/MS) subgroup 6A as petitioned from 1.6 ppm power and responsibilities among the
method (Method D0008) using selected to 5.0 ppm. various levels of government or between
ion monitoring (SIM) of major ions is the Federal Government and Indian
available for enforcing boscalid V. Conclusion tribes. Thus, the Agency has determined
tolerances in plant commodities, and an Therefore, a tolerance is established that Executive Order 13132, entitled
adequate GC/electron capture detection for residues of boscalid, boscalid, 3- ‘‘Federalism’’ (64 FR 43255, August 10,
method (ECD) (Method DFG S19) is pyridinecarboxamide,2-chloro-N-(4′- 1999) and Executive Order 13175,
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![Federal Register / Vol. 82, No. 229 / Thursday, November 30, 2017 / Rules and Regulations 56739
entitled ‘‘Consultation and Coordination * * * * * list of North American Industrial
with Indian Tribal Governments’’ (65 FR [FR Doc. 2017–25832 Filed 11–29–17; 8:45 am] Classification System (NAICS) codes is
67249, November 9, 2000) do not apply BILLING CODE 6560–50–P not intended to be exhaustive, but rather
to this action. In addition, this action provides a guide to help readers
does not impose any enforceable duty or determine whether this document
contain any unfunded mandate as ENVIRONMENTAL PROTECTION applies to them. Potentially affected
described under Title II of the Unfunded AGENCY entities may include:
Mandates Reform Act (UMRA) (2 U.S.C. • Crop production (NAICS code 111).
1501 et seq.). 40 CFR Part 180 • Animal production (NAICS code
This action does not involve any [EPA–HQ–OPP–2016–0295; FRL–9967–73] 112).
technical standards that would require • Food manufacturing (NAICS code
Agency consideration of voluntary Nitrapyrin; Pesticide Tolerances 311).
consensus standards pursuant to section • Pesticide manufacturing (NAICS
AGENCY: Environmental Protection code 32532).
12(d) of the National Technology Agency (EPA).
Transfer and Advancement Act B. How can I get electronic access to
ACTION: Final rule.
(NTTAA) (15 U.S.C. 272 note). other related information?
VII. Congressional Review Act SUMMARY: This regulation establishes You may access a frequently updated
tolerances for residues of nitrapyrin in electronic version of EPA’s tolerance
Pursuant to the Congressional Review or on almond hulls and the tree nut
Act (5 U.S.C. 801 et seq.), EPA will regulations at 40 CFR part 180 through
group 14–12. Dow AgroSciences the Government Printing Office’s e-CFR
submit a report containing this rule and requested these tolerances under the
other required information to the U.S. site at http://www.ecfr.gov/cgi-bin/text-
Federal Food, Drug, and Cosmetic Act idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
Senate, the U.S. House of (FFDCA).
Representatives, and the Comptroller 40tab_02.tpl.
DATES: This regulation is effective
General of the United States prior to C. How can I file an objection or hearing
November 30, 2017. Objections and
publication of the rule in the Federal request?
requests for hearings must be received
Register. This action is not a ‘‘major Under FFDCA section 408(g), 21
on or before January 29, 2018, and must
rule’’ as defined by 5 U.S.C. 804(2). U.S.C. 346a, any person may file an
be filed in accordance with the
List of Subjects in 40 CFR Part 180 instructions provided in 40 CFR part objection to any aspect of this regulation
178 (see also Unit I.C. of the and may also request a hearing on those
Environmental protection,
SUPPLEMENTARY INFORMATION). objections. You must file your objection
Administrative practice and procedure,
ADDRESSES: The docket for this action, or request a hearing on this regulation
Agricultural commodities, Pesticides
identified by docket identification (ID) in accordance with the instructions
and pests, Reporting and recordkeeping
number EPA–HQ–OPP–2016–0295, is provided in 40 CFR part 178. To ensure
requirements.
available at http://www.regulations.gov proper receipt by EPA, you must
Dated: October 5, 2017. or at the Office of Pesticide Programs identify docket ID number EPA–HQ–
Daniel Kenny, Regulatory Public Docket (OPP Docket) OPP–2016–0295 in the subject line on
Acting Director, Registration Division, Office in the Environmental Protection Agency the first page of your submission. All
of Pesticide Programs. Docket Center (EPA/DC), West William objections and requests for a hearing
Therefore, 40 CFR chapter I is Jefferson Clinton Bldg., Rm. 3334, 1301 must be in writing, and must be
amended as follows: Constitution Ave. NW., Washington, DC received by the Hearing Clerk on or
20460–0001. The Public Reading Room before January 29, 2018. Addresses for
PART 180—[AMENDED] is open from 8:30 a.m. to 4:30 p.m., mail and hand delivery of objections
Monday through Friday, excluding legal and hearing requests are provided in 40
■ 1. The authority citation for part 180 holidays. The telephone number for the CFR 178.25(b).
continues to read as follows: Public Reading Room is (202) 566–1744, In addition to filing an objection or
Authority: 21 U.S.C. 321(q), 346a and 371. and the telephone number for the OPP hearing request with the Hearing Clerk
Docket is (703) 305–5805. Please review as described in 40 CFR part 178, please
■ 2. In § 180.589, revise the entry for submit a copy of the filing (excluding
the visitor instructions and additional
‘‘Vegetable, legume, edible podded any Confidential Business Information
information about the docket available
subgroup 6A’’ in the table in paragraph (CBI)) for inclusion in the public docket.
at http://www.epa.gov/dockets.
(a)(1) to read as follows: Information not marked confidential
FOR FURTHER INFORMATION CONTACT:
§ 180.589 Boscalid; tolerances for Michael Goodis, Registration Division pursuant to 40 CFR part 2 may be
residues. (7505P), Office of Pesticide Programs, disclosed publicly by EPA without prior
Environmental Protection Agency, 1200 notice. Submit the non-CBI copy of your
(a) * * *
Pennsylvania Ave. NW., Washington, objection or hearing request, identified
(1) * * * by docket ID number EPA–HQ–OPP–
DC 20460–0001; main telephone
Parts per number: (703) 305–7090; email address: 2016–0295, by one of the following
Commodity methods:
million RDFRNotices@epa.gov.
• Federal eRulemaking Portal: http://
SUPPLEMENTARY INFORMATION:
www.regulations.gov. Follow the online
sradovich on DSK3GMQ082PROD with RULES
* * * * * I. General Information instructions for submitting comments.
Do not submit electronically any
Vegetable, legume, edible pod- A. Does this action apply to me? information you consider to be CBI or
ded subgroup 6A .................... 5.0 You may be potentially affected by other information whose disclosure is
this action if you are an agricultural restricted by statute.
* * * * *
producer, food manufacturer, or • Mail: OPP Docket, Environmental
pesticide manufacturer. The following Protection Agency Docket Center (EPA/
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Document Created: 2017-11-30 00:34:36
Document Modified: 2017-11-30 00:34:36
| 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 November 30, 2017. Objections and requests for hearings must be received on or before January 29, 2018, 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 | Michael L. Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460- | |
| FR Citation | 82 FR 56735 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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