83_FR_52989 83 FR 52787 - Receipt of Several Pesticide Petitions Filed for Residues of Pesticide Chemicals in or on Various Commodities

83 FR 52787 - Receipt of Several Pesticide Petitions Filed for Residues of Pesticide Chemicals in or on Various Commodities

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 83, Issue 202 (October 18, 2018)

Page Range52787-52789
FR Document2018-22659

This document announces the Agency's receipt of several

Federal Register, Volume 83 Issue 202 (Thursday, October 18, 2018)
[Federal Register Volume 83, Number 202 (Thursday, October 18, 2018)]
[Proposed Rules]
[Pages 52787-52789]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-22659]



========================================================================

Proposed Rules

                                                Federal Register

________________________________________________________________________



This section of the FEDERAL REGISTER contains notices to the public of 

the proposed issuance of rules and regulations. The purpose of these 

notices is to give interested persons an opportunity to participate in 

the rule making prior to the adoption of the final rules.



========================================================================





Federal Register / Vol. 83, No. 202 / Thursday, October 18, 2018 / 

Proposed Rules



[[Page 52787]]







ENVIRONMENTAL PROTECTION AGENCY



40 CFR Part 180



[EPA-HQ-OPP-2018-0577; FRL-9984-21]




Receipt of Several Pesticide Petitions Filed for Residues of 

Pesticide Chemicals in or on Various Commodities



AGENCY: Environmental Protection Agency (EPA).



ACTION: Notice of filing of petitions and request for comment.



-----------------------------------------------------------------------



SUMMARY: This document announces the Agency's receipt of several 

initial filings of pesticide petitions requesting the establishment or 

modification of regulations for residues of pesticide chemicals in or 

on various commodities.



DATES: Comments must be received on or before November 19, 2018.



ADDRESSES: Submit your comments, identified by the docket 

identification (ID) number and the pesticide petition number (PP) of 

interest as shown in the body of this document, 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 Confidential Business 

Information (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.



FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division 

(7505P), main telephone number: (703) 305-7090, email address: 

[email protected]; or Robert McNally, Biopesticides and Pollution 

Prevention Division (7511P), main telephone number: (703) 305-7090, 

email address: [email protected]. The mailing address for each 

contact person is: Office of Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-

0001. As part of the mailing address, include the contact person's 

name, division, and mail code. The division to contact is listed at the 

end of each pesticide petition summary.



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).

    If you have any questions regarding the applicability of this 

action to a particular entity, consult the person listed under FOR 

FURTHER INFORMATION CONTACT for the division listed at the end of the 

pesticide petition summary of interest.



B. What should I consider as I prepare my comments for EPA?



    1. Submitting CBI. Do not submit this information to EPA through 

regulations.gov or email. Clearly mark the part or all of the 

information that you claim to be CBI. For CBI information in a disk or 

CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as 

CBI and then identify electronically within the disk or CD-ROM the 

specific information that is claimed as CBI. In addition to one 

complete version of the comment that includes information claimed as 

CBI, a copy of the comment that does not contain the information 

claimed as CBI must be submitted for inclusion in the public docket. 

Information so marked will not be disclosed except in accordance with 

procedures set forth in 40 CFR part 2.

    2. Tips for preparing your comments. When preparing and submitting 

your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

    3. Environmental justice. EPA seeks to achieve environmental 

justice, the fair treatment and meaningful involvement of any group, 

including minority and/or low-income populations, in the development, 

implementation, and enforcement of environmental laws, regulations, and 

policies. To help address potential environmental justice issues, the 

Agency seeks information on any groups or segments of the population 

who, as a result of their location, cultural practices, or other 

factors, may have atypical or disproportionately high and adverse human 

health impacts or environmental effects from exposure to the pesticides 

discussed in this document, compared to the general population.



II. What action is the Agency taking?



    EPA is announcing its receipt of several pesticide petitions filed 

under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 

21 U.S.C. 346a, requesting the establishment or modification of 

regulations in 40 CFR part 180 for residues of pesticide chemicals in 

or on various food commodities. The Agency is taking public comment on 

the requests before responding to the petitioners. EPA is not proposing 

any particular action at this time. EPA has determined that the 

pesticide petitions described in this document contain the data or 

information prescribed in FFDCA section 408(d)(2), 21 U.S.C. 

346a(d)(2); however, EPA has not fully evaluated the sufficiency of the 

submitted data at this time or whether the data support granting of the 

pesticide petitions. After considering the public comments, EPA intends 

to evaluate whether and what action may be warranted. Additional data 

may be needed before EPA can make a final determination on these 

pesticide petitions.

    Pursuant to 40 CFR 180.7(f), a summary of each of the petitions 

that are the subject of this document, prepared by the petitioner, is 

included



[[Page 52788]]



in a docket EPA has created for each rulemaking. The docket for each of 

the petitions is available at http://www.regulations.gov.

    As specified in FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), EPA 

is publishing notice of the petitions so that the public has an 

opportunity to comment on these requests for the establishment or 

modification of regulations for residues of pesticides in or on food 

commodities. Further information on the petitions may be obtained 

through the petition summaries referenced in this unit.



A. Amended Tolerance For Inerts



    PP IN-11139. (EPA-HQ-OPP-2018-0243). Monsanto Company, 1300 I 

Street, NW, Washington, DC 20005, requests to amend tolerances 40 CFR 

180.471 for residues of furilazole (3-dichloroacetyl-5-(2-furanyl)-2,2-

dimethyloxazolidine; CAS Reg. No. 121776-33-8) when used as an inert 

ingredient (herbicide safener) in or on the raw agricultural 

commodities corn, sweet, forage at 0.01 ppm, corn, sweet, kernel plus 

cob with husks removed at 0.01 parts per million (ppm), and, corn, 

sweet, stover at 0.01 ppm. The gas liquid chromatography/mass 

spectrometry with selected ion monitoring method is used to measure and 

evaluate the chemical furilazole. Contact: RD.



B. Amended Tolerances for Non-Inerts



    1. PP 8E8684. (EPA-HQ-OPP-2018-0514). Interregional Research 

Project Number 4 (IR-4), Rutgers, The State University of New Jersey, 

500 College Road East, Suite 201W, Princeton, NJ 08540, proposes upon 

establishment of the tolerances referenced in this document under ``New 

Tolerances'' for PP 8E8684, to remove existing tolerances in 40 CFR 

180.585 for residues of the herbicide pyraflufen-ethyl, ethyl 2-[2-

chloro-5-(4-chloro-5-difluoromethoxy)-1-methyl-1H-pyrazol-3-yl]-4-

fluorophenoxy] acetate, and its acid metabolite, E-1, 2-chloro-5-(4-

chloro-5-difluoromethoxy-1-methyl-1H-pyrazol-3-yl)-4-

fluorophenoxyacetic acid, calculated as the stoichiometric equivalent 

of pyraflufen-ethyl in or on cotton, undelinted seed at 0.04 ppm; 

fruit, stone, group 12 at 0.01 ppm; grape at 0.01 ppm; nut, tree, group 

14 at 0.01 ppm; olive at 0.01 ppm; and pistachio at 0.01 ppm. Contact: 

RD.

    2. PP 8E8689. (EPA-HQ-OPP-2018-0560). IR-4, Rutgers, The State 

University of New Jersey, 500 College Road East, Suite 201W, Princeton, 

NJ 08540, proposes upon establishment of the tolerances referenced in 

this document under ``New Tolerances'' for PP 8E8689, to remove 

existing tolerances in 40 CFR 180.553 for residues of the fungicide 

fenhexamid (N-2,3-dichloro-4-hydroxyphenyl)-1-methyl 

cyclohexanecarboxamide in or on the raw agricultural commodities: 

Bushberry subgroup 13B at 5.0 ppm; caneberry subgroup 13A at 20.0 ppm, 

cilantro, leaves at 30.0 ppm, fruit, stone, group 12, except plum, 

prune, fresh, postharvest at 10.0 ppm; grape at 4.0 ppm; juneberry at 

5.0 ppm; kiwifruit, postharvest at 15.0 ppm; leafy greens subgroup 4A, 

except spinach at 30.0 ppm; lingonberry at 5.0 ppm; salal at 5.0 ppm; 

strawberry at 3.0 ppm; and vegetable, fruiting, group 8, except nonbell 

pepper at 2.0 ppm. The ``Method for the Determination of KBR 2738 (TM-

402) Residues in Plant Material by HPLC'' is used to measure and 

evaluate the chemical fenhexamid. Contact: RD.



C. New Tolerance Exemptions for Inerts (Except PIPs)



    1. IN-11109. (EPA-HQ-OPP-2018-0201). Exponent, Inc. (1150 

Connecticut Ave, Suite 1100, NW, Washington, DC 20036) on behalf of 

Croda, Inc. (315 Cherry Lane, New Castle, DE 19720) requests to 

establish an exemption from the requirement of a tolerance for residues 

of C1-C4 linear and branched chain alkyl d-glucitol dianhydro alkyl 

ethers (C1-C4 Linear and Branched Chain AD-GDAE) cluster (D-glucitol, 

1,4:3,6-dianhydro-2,5-di-O-methyl-(CAS Reg. No. 5306-85-4), D-glucitol, 

1,4:3,6-dianhydro-2,5-di-O-ethyl- (CAS Reg. No. 30915-81-2), D-

glucitol, 1,4:3,6-dianhydro-2,5-di-O-propyl) (CAS Reg. No.107644-13-3), 

D-glucitol, 1,4:3,6-dianhydro-2,5-bis-O-(1-methylethyl) -,(iso-propyl 

diether) (CAS Reg. No. 103594-41-8), D-glucitol, 1,4:3,6-dianhydro-2,5-

di-O-butyl-(CAS Reg. No. 103594-41-9), D-glucitol, 1,4:3,6-dianhydro-

2,5-di-O-(1-methylpropyl)-, (CAS Reg. No. not assigned) and D-glucitol, 

1,4:3,6-dianhydro-2,5-di-O-(2-methylpropyl)-, (CAS Reg. No. not 

assigned) when used as an inert ingredient (solvent, co-solvent, 

viscosity modifier and adjuvant) in pesticide formulations applied to 

growing crops and raw agricultural commodities after harvest under 40 

CFR 180.910, applied in/on animals under 40 CFR 180.930, in 

antimicrobial formulations used in food contact surfaces in public 

eating places, dairy processing equipment, and food-processing 

equipment and utensils under 40 CFR 180.940(a) and in antimicrobial 

formulations used for dairy processing equipment, and food-processing 

equipment and utensils under 40 CFR 180.940(b). The petitioner believes 

no analytical method is needed because it is not required for an 

exemption from the requirement of a tolerance. Contact: RD.

    2. PP IN-11126. (EPA-HQ-OPP-2018-0191). Spring Trading Company on 

behalf of Clariant, 4000 Monroe Rd., Charlotte, NC 28205, requests to 

establish an exemption from the requirement of a tolerance for residues 

of N,N-Dimethylnonanamide (CAS Reg. No. 6225-08-7) when used as a 

pesticide inert ingredient in pesticide formulations applied to growing 

crops and raw agricultural commodities after harvest under 40 CFR 

180.910 and in pesticide formulations applied to animals under 40 CFR 

1280.930. The petitioner believes no analytical method is needed 

because it is not required for an exemption from the requirement of a 

tolerance. Contact: RD.

    3. PP IN-11175. (EPA-HQ-OPP-2018-0545). SciReg, Inc., 12733 

Director's Loop, Woodbridge, VA 22192, on behalf of Eden Research plc, 

6 Priory Court, Priory Court Business Park, Poulton, Cirencester GL7 

5JB, United Kingdom, requests to establish an exemption from the 

requirement of a tolerance for residues of cell walls of Saccharomyces 

cerevisiae when used as a pesticide inert ingredient in pesticide 

formulations applied to growing crops only under 40 CFR 180.920. The 

petitioner believes no analytical method is needed because it is not 

required for an exemption from the requirement of a tolerance. Contact: 

RD.

    4. PP IN-11189. (EPA-HQ-OPP-2018-0546). Keller and Heckman LLP, 

1001 G Street, NW, Suite 500 West, Washington, DC 20001, on behalf of 

Synthomer USA LLC, requests to establish an exemption from the 

requirement of a tolerance for residues of Polyvinyl acetate--polyvinyl 

alcohol copolymer (CAS Reg. No. 25213-24-5) when used as a pesticide 

inert ingredient in pesticide formulations under 40 CFR 180.960. The 

petitioner believes no analytical method is needed because it is not 

required for an exemption from the requirement of a tolerance. Contact: 

RD.



D. New Tolerances for Non-Inerts



    1. PP 8E8684. (EPA-HQ-OPP-2018-0514). IR-4, Rutgers, The State 

University of New Jersey, 500 College Road East, Suite 201W, Princeton, 

NJ 08540, requests to establish tolerances in 40 CFR part 180.585 for 

residues of the herbicide pyraflufen-ethyl, including its metabolites 

and degradates in or on the raw agricultural commodities (RACs). 

Compliance with the plant commodity tolerance levels specified below is 

to be determined by measuring only the sum of the parent



[[Page 52789]]



pyraflufen-ethyl, ethyl 2-[2-chloro-5-(4-chloro-5-difluoromethoxy)-1-

methyl-1H-pyrazol-3-yl]-4-fluorophenoxy] acetate, and its acid 

metabolite, E-1, 2-chloro-5-(4-chloro-5-difluoromethoxy-1-methyl-1H-

pyrazol-3-yl)-4-fluorophenoxyacetic acid, calculated as the 

stoichiometric equivalent of pyraflufen-ethyl in or on the following 

RACs: Cottonseed subgroup 20C at 0.04 ppm; fruit, small, vine climbing, 

except fuzzy kiwifruit, subgroup 13-07F at 0.01 ppm; fruit, stone, 

group 12-12 at 0.01 ppm; hop, dried cones at 0.02 ppm; nut, tree, group 

14-12 at 0.01 ppm; tropical and subtropical, small fruit, edible peel, 

subgroup 23A at 0.01 ppm; and vegetable, tuberous and corm, subgroup 1C 

at 0.02 ppm. Available analytical methodology involves multiple-step 

extractions of the chemical residues from plants and using Gas 

Chromatograph-Mass Spectrometry (GC-MS) to measure and evaluate 

pyraflufen-ethyl residues. Contact: RD.

    2. PP 8E8689. (EPA-HQ-OPP-2018-0560). IR-4, Rutgers, The State 

University of New Jersey, 500 College Road East, Suite 201W, Princeton, 

NJ 08540, requests to establish tolerances in 40 CFR part 180.553 for 

residues of the fungicide fenhexamid (N-2,3-dichloro-4-hydroxyphenyl)-

1-methyl cyclohexanecarboxamide in or on the raw agricultural 

commodities: Arugula at 30.0 ppm; berry, low growing, subgroup 13-07G 

at 3.0 ppm; bushberry subgroup 13-07B at 5.0 ppm; caneberry subgroup 

13-07A at 20.0 ppm; fruit, small, vine climbing, except fuzzy 

kiwifruit, subgroup 13-07F at 4.0 ppm; fruit, stone, group 12-12, 

except plum, prune, fresh, postharvest at 10.0 ppm; garden cress at 

30.0 ppm; kiwifruit, fuzzy at 30.0 ppm; leafy greens subgroup 4-16A, 

except spinach at 30.0 ppm; onion, bulb, subgroup 3-07A at 2.0 ppm; 

onion, green, subgroup 3-07B at 30.0 ppm; upland cress at 30.0 ppm; and 

vegetable, fruiting, group 8-10, except nonbell pepper at 2.0 ppm. The 

``Method for the Determination of KBR 2738 (TM-402) Residues in Plant 

Material by HPLC'' is used to measure and evaluate the chemical 

fenhexamid. Contact: RD.



    Authority:  21 U.S.C. 346a.



    Dated: October 1, 2018.

Delores Barber,

Director, Information Technology and Resources Management Division, 

Office of Pesticide Programs.

[FR Doc. 2018-22659 Filed 10-17-18; 8:45 am]

 BILLING CODE 6560-50-P





                                                                                                                                                                                                52787

                                                Proposed Rules                                                                                                Federal Register
                                                                                                                                                              Vol. 83, No. 202

                                                                                                                                                              Thursday, October 18, 2018



                                                This section of the FEDERAL REGISTER                    (7505P), main telephone number: (703)                 contain the information claimed as CBI
                                                contains notices to the public of the proposed          305–7090, email address:                              must be submitted for inclusion in the
                                                issuance of rules and regulations. The                  RDFRNotices@epa.gov; or Robert                        public docket. Information so marked
                                                purpose of these notices is to give interested          McNally, Biopesticides and Pollution                  will not be disclosed except in
                                                persons an opportunity to participate in the            Prevention Division (7511P), main                     accordance with procedures set forth in
                                                rule making prior to the adoption of the final
                                                                                                        telephone number: (703) 305–7090,                     40 CFR part 2.
                                                rules.
                                                                                                        email address: BPPDFRNotices@                            2. Tips for preparing your comments.
                                                                                                        epa.gov. The mailing address for each                 When preparing and submitting your
                                                ENVIRONMENTAL PROTECTION                                contact person is: Office of Pesticide                comments, see the commenting tips at
                                                AGENCY                                                  Programs, Environmental Protection                    http://www.epa.gov/dockets/
                                                                                                        Agency, 1200 Pennsylvania Ave. NW,                    comments.html.
                                                40 CFR Part 180                                         Washington, DC 20460–0001. As part of                    3. Environmental justice. EPA seeks to
                                                                                                        the mailing address, include the contact              achieve environmental justice, the fair
                                                [EPA–HQ–OPP–2018–0577; FRL–9984–21]                                                                           treatment and meaningful involvement
                                                                                                        person’s name, division, and mail code.
                                                                                                        The division to contact is listed at the              of any group, including minority and/or
                                                Receipt of Several Pesticide Petitions
                                                                                                        end of each pesticide petition summary.               low-income populations, in the
                                                Filed for Residues of Pesticide
                                                                                                        SUPPLEMENTARY INFORMATION:
                                                                                                                                                              development, implementation, and
                                                Chemicals in or on Various                                                                                    enforcement of environmental laws,
                                                Commodities                                             I. General Information                                regulations, and policies. To help
                                                AGENCY:  Environmental Protection                                                                             address potential environmental justice
                                                                                                        A. Does this action apply to me?
                                                Agency (EPA).                                                                                                 issues, the Agency seeks information on
                                                                                                           You may be potentially affected by                 any groups or segments of the
                                                ACTION: Notice of filing of petitions and
                                                                                                        this action if you are an agricultural                population who, as a result of their
                                                request for comment.
                                                                                                        producer, food manufacturer, or                       location, cultural practices, or other
                                                SUMMARY:   This document announces the                  pesticide manufacturer. The following                 factors, may have atypical or
                                                Agency’s receipt of several initial filings             list of North American Industrial                     disproportionately high and adverse
                                                of pesticide petitions requesting the                   Classification System (NAICS) codes is                human health impacts or environmental
                                                establishment or modification of                        not intended to be exhaustive, but rather             effects from exposure to the pesticides
                                                regulations for residues of pesticide                   provides a guide to help readers                      discussed in this document, compared
                                                chemicals in or on various commodities.                 determine whether this document                       to the general population.
                                                DATES: Comments must be received on                     applies to them. Potentially affected
                                                                                                        entities may include:                                 II. What action is the Agency taking?
                                                or before November 19, 2018.
                                                                                                           • Crop production (NAICS code 111).                   EPA is announcing its receipt of
                                                ADDRESSES: Submit your comments,                           • Animal production (NAICS code                    several pesticide petitions filed under
                                                identified by the docket identification                 112).                                                 section 408 of the Federal Food, Drug,
                                                (ID) number and the pesticide petition                     • Food manufacturing (NAICS code                   and Cosmetic Act (FFDCA), 21 U.S.C.
                                                number (PP) of interest as shown in the                 311).                                                 346a, requesting the establishment or
                                                body of this document, by one of the                       • Pesticide manufacturing (NAICS                   modification of regulations in 40 CFR
                                                following methods:                                      code 32532).                                          part 180 for residues of pesticide
                                                  • Federal eRulemaking Portal: http://                    If you have any questions regarding                chemicals in or on various food
                                                www.regulations.gov. Follow the online                  the applicability of this action to a                 commodities. The Agency is taking
                                                instructions for submitting comments.                   particular entity, consult the person                 public comment on the requests before
                                                Do not submit electronically any                        listed under FOR FURTHER INFORMATION                  responding to the petitioners. EPA is not
                                                information you consider to be                          CONTACT for the division listed at the                proposing any particular action at this
                                                Confidential Business Information (CBI)                 end of the pesticide petition summary of              time. EPA has determined that the
                                                or other information whose disclosure is                interest.                                             pesticide petitions described in this
                                                restricted by statute.                                                                                        document contain the data or
                                                  • Mail: OPP Docket, Environmental                     B. What should I consider as I prepare
                                                                                                                                                              information prescribed in FFDCA
                                                Protection Agency Docket Center (EPA/                   my comments for EPA?
                                                                                                                                                              section 408(d)(2), 21 U.S.C. 346a(d)(2);
                                                DC), (28221T), 1200 Pennsylvania Ave.                      1. Submitting CBI. Do not submit this              however, EPA has not fully evaluated
                                                NW, Washington, DC 20460–0001.                          information to EPA through                            the sufficiency of the submitted data at
                                                  • Hand Delivery: To make special                      regulations.gov or email. Clearly mark                this time or whether the data support
                                                arrangements for hand delivery or                       the part or all of the information that               granting of the pesticide petitions. After
                                                delivery of boxed information, please                   you claim to be CBI. For CBI                          considering the public comments, EPA
                                                follow the instructions at http://                      information in a disk or CD–ROM that                  intends to evaluate whether and what
khammond on DSK30JT082PROD with PROPOSAL




                                                www.epa.gov/dockets/contacts.html.                      you mail to EPA, mark the outside of the              action may be warranted. Additional
                                                  Additional instructions on                            disk or CD–ROM as CBI and then                        data may be needed before EPA can
                                                commenting or visiting the docket,                      identify electronically within the disk or            make a final determination on these
                                                along with more information about                       CD–ROM the specific information that                  pesticide petitions.
                                                dockets generally, is available at http://              is claimed as CBI. In addition to one                    Pursuant to 40 CFR 180.7(f), a
                                                www.epa.gov/dockets.                                    complete version of the comment that                  summary of each of the petitions that
                                                FOR FURTHER INFORMATION CONTACT:                        includes information claimed as CBI, a                are the subject of this document,
                                                Michael Goodis, Registration Division                   copy of the comment that does not                     prepared by the petitioner, is included


                                           VerDate Sep<11>2014   16:13 Oct 17, 2018   Jkt 247001   PO 00000   Frm 00001   Fmt 4702   Sfmt 4702   E:\FR\FM\18OCP1.SGM   18OCP1


                                                52788                 Federal Register / Vol. 83, No. 202 / Thursday, October 18, 2018 / Proposed Rules

                                                in a docket EPA has created for each                    PP 8E8689, to remove existing                         because it is not required for an
                                                rulemaking. The docket for each of the                  tolerances in 40 CFR 180.553 for                      exemption from the requirement of a
                                                petitions is available at http://                       residues of the fungicide fenhexamid                  tolerance. Contact: RD.
                                                www.regulations.gov.                                    (N–2,3-dichloro-4-hydroxyphenyl)-1-                      2. PP IN–11126. (EPA–HQ–OPP–
                                                  As specified in FFDCA section                         methyl cyclohexanecarboxamide in or                   2018–0191). Spring Trading Company
                                                408(d)(3), 21 U.S.C. 346a(d)(3), EPA is                 on the raw agricultural commodities:                  on behalf of Clariant, 4000 Monroe Rd.,
                                                publishing notice of the petitions so that              Bushberry subgroup 13B at 5.0 ppm;                    Charlotte, NC 28205, requests to
                                                the public has an opportunity to                        caneberry subgroup 13A at 20.0 ppm,                   establish an exemption from the
                                                comment on these requests for the                       cilantro, leaves at 30.0 ppm, fruit, stone,           requirement of a tolerance for residues
                                                establishment or modification of                        group 12, except plum, prune, fresh,                  of N,N-Dimethylnonanamide (CAS Reg.
                                                regulations for residues of pesticides in               postharvest at 10.0 ppm; grape at 4.0                 No. 6225–08–7) when used as a
                                                or on food commodities. Further                         ppm; juneberry at 5.0 ppm; kiwifruit,                 pesticide inert ingredient in pesticide
                                                information on the petitions may be                     postharvest at 15.0 ppm; leafy greens                 formulations applied to growing crops
                                                obtained through the petition                           subgroup 4A, except spinach at 30.0                   and raw agricultural commodities after
                                                summaries referenced in this unit.                      ppm; lingonberry at 5.0 ppm; salal at 5.0             harvest under 40 CFR 180.910 and in
                                                                                                        ppm; strawberry at 3.0 ppm; and                       pesticide formulations applied to
                                                A. Amended Tolerance For Inerts
                                                                                                        vegetable, fruiting, group 8, except                  animals under 40 CFR 1280.930. The
                                                   PP IN–11139. (EPA–HQ–OPP–2018–                       nonbell pepper at 2.0 ppm. The                        petitioner believes no analytical method
                                                0243). Monsanto Company, 1300 I                         ‘‘Method for the Determination of KBR                 is needed because it is not required for
                                                Street, NW, Washington, DC 20005,                       2738 (TM–402) Residues in Plant                       an exemption from the requirement of a
                                                requests to amend tolerances 40 CFR                     Material by HPLC’’ is used to measure                 tolerance. Contact: RD.
                                                180.471 for residues of furilazole (3-                  and evaluate the chemical fenhexamid.                    3. PP IN–11175. (EPA–HQ–OPP–
                                                dichloroacetyl-5-(2-furanyl)-2,2-                       Contact: RD.                                          2018–0545). SciReg, Inc., 12733
                                                dimethyloxazolidine; CAS Reg. No.                                                                             Director’s Loop, Woodbridge, VA 22192,
                                                121776–33–8) when used as an inert                      C. New Tolerance Exemptions for Inerts                on behalf of Eden Research plc, 6 Priory
                                                ingredient (herbicide safener) in or on                 (Except PIPs)                                         Court, Priory Court Business Park,
                                                the raw agricultural commodities corn,                     1. IN–11109. (EPA–HQ–OPP–2018–                     Poulton, Cirencester GL7 5JB, United
                                                sweet, forage at 0.01 ppm, corn, sweet,                 0201). Exponent, Inc. (1150 Connecticut               Kingdom, requests to establish an
                                                kernel plus cob with husks removed at                   Ave, Suite 1100, NW, Washington, DC                   exemption from the requirement of a
                                                0.01 parts per million (ppm), and, corn,                20036) on behalf of Croda, Inc. (315                  tolerance for residues of cell walls of
                                                sweet, stover at 0.01 ppm. The gas                      Cherry Lane, New Castle, DE 19720)                    Saccharomyces cerevisiae when used as
                                                liquid chromatography/mass                              requests to establish an exemption from               a pesticide inert ingredient in pesticide
                                                spectrometry with selected ion                          the requirement of a tolerance for                    formulations applied to growing crops
                                                monitoring method is used to measure                    residues of C1–C4 linear and branched                 only under 40 CFR 180.920. The
                                                and evaluate the chemical furilazole.                   chain alkyl d-glucitol dianhydro alkyl                petitioner believes no analytical method
                                                Contact: RD.                                            ethers (C1–C4 Linear and Branched                     is needed because it is not required for
                                                                                                        Chain AD–GDAE) cluster (D-glucitol,                   an exemption from the requirement of a
                                                B. Amended Tolerances for Non-Inerts
                                                                                                        1,4:3,6-dianhydro-2,5-di-O-methyl-(CAS                tolerance. Contact: RD.
                                                   1. PP 8E8684. (EPA–HQ–OPP–2018–                      Reg. No. 5306–85–4), D-glucitol, 1,4:3,6-                4. PP IN–11189. (EPA–HQ–OPP–
                                                0514). Interregional Research Project                   dianhydro-2,5-di-O-ethyl- (CAS Reg. No.               2018–0546). Keller and Heckman LLP,
                                                Number 4 (IR–4), Rutgers, The State                     30915–81–2), D-glucitol, 1,4:3,6-                     1001 G Street, NW, Suite 500 West,
                                                University of New Jersey, 500 College                   dianhydro-2,5-di-O-propyl) (CAS Reg.                  Washington, DC 20001, on behalf of
                                                Road East, Suite 201W, Princeton, NJ                    No.107644–13–3), D-glucitol, 1,4:3,6-                 Synthomer USA LLC, requests to
                                                08540, proposes upon establishment of                   dianhydro-2,5-bis-O-(1-methylethyl)                   establish an exemption from the
                                                the tolerances referenced in this                       -,(iso-propyl diether) (CAS Reg. No.                  requirement of a tolerance for residues
                                                document under ‘‘New Tolerances’’ for                   103594–41–8), D-glucitol, 1,4:3,6-                    of Polyvinyl acetate—polyvinyl alcohol
                                                PP 8E8684, to remove existing                           dianhydro-2,5-di-O-butyl-(CAS Reg. No.                copolymer (CAS Reg. No. 25213–24–5)
                                                tolerances in 40 CFR 180.585 for                        103594–41–9), D-glucitol, 1,4:3,6-                    when used as a pesticide inert
                                                residues of the herbicide pyraflufen-                   dianhydro-2,5-di-O-(1-methylpropyl)-,                 ingredient in pesticide formulations
                                                ethyl, ethyl 2-[2-chloro-5-(4-chloro-5-                 (CAS Reg. No. not assigned) and D-                    under 40 CFR 180.960. The petitioner
                                                difluoromethoxy)-1-methyl-1H-pyrazol-                   glucitol, 1,4:3,6-dianhydro-2,5-di-O-(2-              believes no analytical method is needed
                                                3-yl]-4-fluorophenoxy] acetate, and its                 methylpropyl)-, (CAS Reg. No. not                     because it is not required for an
                                                acid metabolite, E–1, 2-chloro-5-(4-                    assigned) when used as an inert                       exemption from the requirement of a
                                                chloro-5-difluoromethoxy-1-methyl-1H-                   ingredient (solvent, co-solvent, viscosity            tolerance. Contact: RD.
                                                pyrazol-3-yl)-4-fluorophenoxyacetic                     modifier and adjuvant) in pesticide
                                                acid, calculated as the stoichiometric                  formulations applied to growing crops                 D. New Tolerances for Non-Inerts
                                                equivalent of pyraflufen-ethyl in or on                 and raw agricultural commodities after                  1. PP 8E8684. (EPA–HQ–OPP–2018–
                                                cotton, undelinted seed at 0.04 ppm;                    harvest under 40 CFR 180.910, applied                 0514). IR–4, Rutgers, The State
                                                fruit, stone, group 12 at 0.01 ppm; grape               in/on animals under 40 CFR 180.930, in                University of New Jersey, 500 College
                                                at 0.01 ppm; nut, tree, group 14 at 0.01                antimicrobial formulations used in food               Road East, Suite 201W, Princeton, NJ
                                                ppm; olive at 0.01 ppm; and pistachio                   contact surfaces in public eating places,             08540, requests to establish tolerances
khammond on DSK30JT082PROD with PROPOSAL




                                                at 0.01 ppm. Contact: RD.                               dairy processing equipment, and food-                 in 40 CFR part 180.585 for residues of
                                                   2. PP 8E8689. (EPA–HQ–OPP–2018–                      processing equipment and utensils                     the herbicide pyraflufen-ethyl,
                                                0560). IR–4, Rutgers, The State                         under 40 CFR 180.940(a) and in                        including its metabolites and degradates
                                                University of New Jersey, 500 College                   antimicrobial formulations used for                   in or on the raw agricultural
                                                Road East, Suite 201W, Princeton, NJ                    dairy processing equipment, and food-                 commodities (RACs). Compliance with
                                                08540, proposes upon establishment of                   processing equipment and utensils                     the plant commodity tolerance levels
                                                the tolerances referenced in this                       under 40 CFR 180.940(b). The petitioner               specified below is to be determined by
                                                document under ‘‘New Tolerances’’ for                   believes no analytical method is needed               measuring only the sum of the parent


                                           VerDate Sep<11>2014   16:13 Oct 17, 2018   Jkt 247001   PO 00000   Frm 00002   Fmt 4702   Sfmt 4702   E:\FR\FM\18OCP1.SGM   18OCP1


                                                                      Federal Register / Vol. 83, No. 202 / Thursday, October 18, 2018 / Proposed Rules                                         52789

                                                pyraflufen-ethyl, ethyl 2-[2-chloro-5-(4-               DEPARTMENT OF HEALTH AND                                Please allow sufficient time for mailed
                                                chloro-5-difluoromethoxy)-1-methyl-1H-                  HUMAN SERVICES                                        comments to be received before the
                                                pyrazol-3-yl]-4-fluorophenoxy] acetate,                                                                       close of the comment period.
                                                and its acid metabolite, E–1, 2-chloro-5-               Centers for Medicare & Medicaid                         3. By express or overnight mail. You
                                                (4-chloro-5-difluoromethoxy-1-methyl-                   Services                                              may send written comments to the
                                                1H-pyrazol-3-yl)-4-fluorophenoxyacetic                                                                        following address ONLY: Centers for
                                                acid, calculated as the stoichiometric                  42 CFR Part 403                                       Medicare & Medicaid Services,
                                                equivalent of pyraflufen-ethyl in or on                                                                       Department of Health and Human
                                                                                                        [CMS–4187–P]                                          Services, Attention: CMS–4187–P, Mail
                                                the following RACs: Cottonseed
                                                                                                                                                              Stop C4–26–05, 7500 Security
                                                subgroup 20C at 0.04 ppm; fruit, small,                 RIN 0938–AT87                                         Boulevard, Baltimore, MD 21244–1850.
                                                vine climbing, except fuzzy kiwifruit,                                                                          For information on viewing public
                                                subgroup 13–07F at 0.01 ppm; fruit,                     Medicare and Medicaid Programs;
                                                                                                                                                              comments, see the beginning of the
                                                stone, group 12–12 at 0.01 ppm; hop,                    Regulation To Require Drug Pricing
                                                                                                                                                              SUPPLEMENTARY INFORMATION section.
                                                dried cones at 0.02 ppm; nut, tree, group               Transparency
                                                                                                                                                              FOR FURTHER INFORMATION CONTACT:
                                                14–12 at 0.01 ppm; tropical and                         AGENCY:  Centers for Medicare &                       Cheri Rice, (410) 786–6499.
                                                subtropical, small fruit, edible peel,                  Medicaid Services (CMS), HHS.                         SUPPLEMENTARY INFORMATION: Inspection
                                                subgroup 23A at 0.01 ppm; and                           ACTION: Proposed rule.                                of Public Comments: All comments
                                                vegetable, tuberous and corm, subgroup                                                                        received before the close of the
                                                1C at 0.02 ppm. Available analytical                    SUMMARY:    This proposed rule would                  comment period are available for
                                                methodology involves multiple-step                      revise the Federal Health Insurance                   viewing by the public, including any
                                                extractions of the chemical residues                    Programs for the Aged and Disabled by                 personally identifiable or confidential
                                                from plants and using Gas                               amending the Medicare Parts A, B, C                   business information that is included in
                                                Chromatograph-Mass Spectrometry                         and D programs, as well as the Medicaid               a comment. We post all comments
                                                (GC–MS) to measure and evaluate                         program, to require direct-to-consumer                received before the close of the
                                                pyraflufen-ethyl residues. Contact: RD.                 (DTC) television advertisements of                    comment period on the following
                                                                                                        prescription drugs and biological                     website as soon as possible after they
                                                   2. PP 8E8689. (EPA–HQ–OPP–2018–
                                                                                                        products for which payment is available               have been received: http://
                                                0560). IR–4, Rutgers, The State
                                                                                                        through or under Medicare or Medicaid                 www.regulations.gov. Follow the search
                                                University of New Jersey, 500 College                   to include the Wholesale Acquisition
                                                Road East, Suite 201W, Princeton, NJ                                                                          instructions on that website to view
                                                                                                        Cost (WAC, or ‘‘list price’’) of that drug            public comments.
                                                08540, requests to establish tolerances                 or biological product. We are proposing
                                                in 40 CFR part 180.553 for residues of                  this regulation to improve the efficient              I. Background
                                                the fungicide fenhexamid (N–2,3-                        administration of the Medicare and                    A. Purpose
                                                dichloro-4-hydroxyphenyl)-1-methyl                      Medicaid programs by ensuring that
                                                cyclohexanecarboxamide in or on the                                                                              The purpose of this proposed rule is
                                                                                                        beneficiaries are provided with relevant
                                                raw agricultural commodities: Arugula                                                                         to reduce the price to consumers of
                                                                                                        information about the costs of
                                                at 30.0 ppm; berry, low growing,                                                                              prescription drugs and biological
                                                                                                        prescription drugs and biological
                                                                                                                                                              products. This rule would require
                                                subgroup 13–07G at 3.0 ppm; bushberry                   products so they can make informed
                                                                                                                                                              direct-to-consumer (DTC) television
                                                subgroup 13–07B at 5.0 ppm; caneberry                   decisions that minimize not only their
                                                                                                                                                              advertisements for prescription drug
                                                subgroup 13–07A at 20.0 ppm; fruit,                     out-of-pocket costs, but also
                                                                                                                                                              and biological products for which
                                                small, vine climbing, except fuzzy                      expenditures borne by Medicare and
                                                                                                                                                              reimbursement is available, directly or
                                                kiwifruit, subgroup 13–07F at 4.0 ppm;                  Medicaid, both of which are significant
                                                                                                                                                              indirectly, through or under Medicare or
                                                fruit, stone, group 12–12, except plum,                 problems.
                                                                                                                                                              Medicaid to include the list price of that
                                                prune, fresh, postharvest at 10.0 ppm;                  DATES: To be assured consideration,                   product. We are proposing this
                                                garden cress at 30.0 ppm; kiwifruit,                    comments must be received at one of                   regulation to improve the efficient
                                                fuzzy at 30.0 ppm; leafy greens                         the addresses provided below, no later                administration of the Medicare and
                                                subgroup 4–16A, except spinach at 30.0                  than 5 p.m. on December 17, 2018.                     Medicaid programs by ensuring that
                                                ppm; onion, bulb, subgroup 3–07A at                     ADDRESSES: In commenting, please refer                beneficiaries are provided with relevant
                                                2.0 ppm; onion, green, subgroup 3–07B                   to file code CMS–4187–P. Because of                   information about the costs of
                                                at 30.0 ppm; upland cress at 30.0 ppm;                  staff and resource limitations, we cannot             prescription drugs and biological
                                                and vegetable, fruiting, group 8–10,                    accept comments by facsimile (FAX)                    products so they can make informed
                                                except nonbell pepper at 2.0 ppm. The                   transmission. Comments, including                     decisions that minimize not only their
                                                ‘‘Method for the Determination of KBR                   mass comment submissions, must be                     out-of-pocket costs, but also
                                                2738 (TM–402) Residues in Plant                         submitted in one of the following three               unreasonable expenditures borne by
                                                Material by HPLC’’ is used to measure                   ways (please choose only one of the                   Medicare and Medicaid, both of which
                                                and evaluate the chemical fenhexamid.                   ways listed):                                         are significant problems.
                                                Contact: RD.                                               1. Electronically. You may submit                     Markets operate more efficiently
                                                                                                        electronic comments on this regulation                when consumers have relevant
                                                   Authority: 21 U.S.C. 346a.                           to http://www.regulations.gov. Follow                 information about a product, including
khammond on DSK30JT082PROD with PROPOSAL




                                                  Dated: October 1, 2018.                               the ‘‘Submit a comment’’ instructions.                its price, as well as alternative products
                                                Delores Barber,                                            2. By regular mail. You may mail                   and their prices, before making an
                                                Director, Information Technology and
                                                                                                        written comments to the following                     informed decision whether to buy that
                                                Resources Management Division, Office of                address ONLY: Centers for Medicare &                  product or, instead, a competing one.
                                                Pesticide Programs.                                     Medicaid Services, Department of                      Consumers price shop when looking to
                                                [FR Doc. 2018–22659 Filed 10–17–18; 8:45 am]
                                                                                                        Health and Human Services, Attention:                 purchase a new car, a new house, or
                                                                                                        CMS–4187–P, P.O. Box 8013, Baltimore,                 even a new coffee maker. Price
                                                BILLING CODE 6560–50–P
                                                                                                        MD 21244–8013.                                        shopping is the mark of rational


                                           VerDate Sep<11>2014   16:13 Oct 17, 2018   Jkt 247001   PO 00000   Frm 00003   Fmt 4702   Sfmt 4702   E:\FR\FM\18OCP1.SGM   18OCP1



Document Created: 2018-10-18 03:05:29
Document Modified: 2018-10-18 03:05:29
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionNotice of filing of petitions and request for comment.
DatesComments must be received on or before November 19, 2018.
ContactMichael Goodis, Registration Division
FR Citation83 FR 52787 

2024 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR