82 FR 43354 - Request for Public Comments To Be Sent to EPA on Peer Review Materials To Inform the Safe Drinking Water Act Decision Making on Perchlorate
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 82, Issue 178 (September 15, 2017)
Federal Register Volume 82, Issue 178 (September 15, 2017)
| Page Range | 43354-43356 | |
| FR Document | 2017-19703 |
[Federal Register Volume 82, Number 178 (Friday, September 15, 2017)] [Notices] [Pages 43354-43356] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-19703] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OW-2016-0438; FRL-9967-69-OW] Request for Public Comments To Be Sent to EPA on Peer Review Materials To Inform the Safe Drinking Water Act Decision Making on Perchlorate AGENCY: Environmental Protection Agency (EPA). ACTION: Notice of request for public comment. ----------------------------------------------------------------------- SUMMARY: The U.S. Environmental Protection Agency (EPA) is announcing the release of materials for public comment. These materials will undergo expert peer review in support of EPA's Safe Drinking Water Act decision making for perchlorate. This request is one of two Federal Register notices being published concurrently, seeking public comment on two separate sets of peer review materials. This notice requests comments (to be sent to EPA) on a draft report entitled ``Draft Report: Proposed Approaches to Inform the Derivation of a Maximum Contaminant Level Goal for Perchlorate in Drinking Water'' (draft MCLG Approaches Report). The companion notice requests comments (to be sent to EPA's contractor, Versar, Inc.) on an interim list of peer reviewers and draft charge questions. DATES: Comments must be received by EPA on or before October 30, 2017. [[Page 43355]] ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-OW- 2016-0438 to the Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or withdrawn. The EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (i.e., on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets. FOR FURTHER INFORMATION CONTACT: For additional information concerning the draft MCLG Approaches Report, please contact Samuel Hernandez at U.S. EPA, Office of Ground Water and Drinking Water, Standards and Risk Management Division, (Mail Code 4607M), 1200 Pennsylvania Avenue NW., Washington, DC 20460; telephone: 202-564-1735; or email: [email protected]. SUPPLEMENTARY INFORMATION: I. Information on EPA's Revised Biologically Based Dose-Response (BBDR) Model As a part of the national primary drinking water regulation (NPDWR) development process for perchlorate, in accordance with the requirements of the Safe Drinking Water Act, in 2012, EPA requested comment from EPA's Science Advisory Board (SAB) prior to proposing an MCLG and a NPDWR for perchlorate. EPA sought guidance on how best to consider and interpret life stage information, epidemiologic and biomonitoring data, physiologically-based pharmacokinetic analyses and the totality of perchlorate health related information to derive a perchlorate MCLG. In 2013, the SAB recommended that, ``. . . EPA derive a perchlorate MCLG that addresses sensitive life stages through physiologically-based pharmacokinetic/pharmacodynamic (PBPK/PD) modeling based upon its mode of action rather than the default MCLG approach using the reference dose and specific chemical exposure parameters'' (Advice on Approaches to Derive a Maximum Contaminant Level Goal for Perchlorate, EPA-SAB-13- 004). Based on the SAB's recommendations, EPA, with contributions from Food and Drug Administration scientists, developed a biologically based dose response (BBDR) (also known as a PBPK/PD) model, to predict the effects of perchlorate on serum thyroid hormone concentrations in pregnant and lactating women exposed to perchlorate in drinking water and in infants exposed via ingestion of perchlorate in formula or breast milk. On January 10 and 11, 2017, EPA's contractor (Versar, Inc.) conducted an independent, scientific peer review of EPA's draft BBDR model and draft model report. The purpose of the peer review was to provide a documented, independent, and critical review of the draft BBDR model and draft model report and to identify any necessary improvements to the model prior to being finalized. On March 29, 2017, EPA received the final peer review report entitled, ``External Peer Review for EPA's Draft Biologically Based Dose-Response (BBDR) Model and Draft BBDR Model Report for Perchlorate in Drinking Water,'' which is available through the EPA docket at https://www.regulations.gov/docket?D=EPA-HQ-OW-2016-0439. In developing the draft MCLG Approaches Report, EPA revised the BBDR model to address those peer review recommendations that had the greatest influence on the scientific rigor of the model and modeling results. Those changes are described in the draft MCLG Approaches Report. EPA will consider other peer review recommendations and public comments in future revisions to the BBDR model and report. II. Information on EPA's Draft Approaches To Inform the Derivation of a Perchlorate MCLG The SAB also recommended that EPA, ``utilize a mode of action (MOA) framework for developing the MCLG that links the steps in the proposed mechanism leading from perchlorate exposure through iodide uptake inhibition to thyroid hormone changes and finally neurodevelopmental impacts.'' EPA used the modeled thyroid hormone levels to predict potential adverse health effects based on published epidemiology data demonstrating a relationship between changes in thyroid hormone levels and neurodevelopmental effects. This approach involved a focused review of the literature connecting altered thyroid hormone levels to neurodevelopmental outcomes for women in early pregnancy. EPA focused on studies that provided a quantitative description of the relationship between free thyroxine and neurodevelopment in infants and children (e.g., intelligence quotient, verbal and problem solving skills and motor coordination). EPA will present an array of approaches to inform the derivation of an MCLG for perchlorate for expert peer review. Using the revised BBDR model output, EPA linked statistical relationships derived from five studies to implement the MOA framework linking perchlorate exposure to neurodevelopmental impacts. All five studies assess the relationship between thyroid hormone levels in women in early pregnancy and various neurodevelopmental effects on children at various ages. Two studies assess the relationship on the IQ of children 5 to 10 years of age, two other studies assess the relationship on Bayley Scales of Infant Development of children 1 to 2 years of age, and a fifth study assesses the relationship on reaction time of children 5 to 6 years of age. An additional approach uses the revised BBDR model output to predict the percent change in the population of hypothyroxinemic (or the low-end of normal thyroid hormone levels) pregnant women due to perchlorate exposure. III. How To Obtain the Draft MCLG Approaches Report and Revised BBDR Model EPA's draft report entitled ``Draft Report: Proposed Approaches to Inform the Derivation of a Maximum Contaminant Level Goal for Perchlorate in Drinking Water'' is available electronically and can be accessed using EPA's public docket at https://www.regulations.gov/docket?D=EPA-HQ-OW-2016-0438. The revised BBDR model code files can be accessed at https://hero.epa.gov/hero/index.cfm/reference/details/reference_id/3352518. All written comments must be submitted during the public comment period. IV. Exclusion for Peer Review Candidates Important: Anyone wishing to be considered as an expert peer reviewer must not submit comments during the public comment period. Candidates on the interim list not selected for the [[Page 43356]] panel peer review (see companion Peer Review Federal Register notice, published on September 15, 2017) will be given a limited opportunity to submit public comments once the final peer reviewers are selected by Versar, Inc., the EPA contractor managing this peer review process. Dated: September 6, 2017. Michael H. Shapiro, Acting Assistant Administrator, Office of Water. [FR Doc. 2017-19703 Filed 9-14-17; 8:45 am] BILLING CODE 6560-50-P
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formulations applied to growing crops tandem mass spectrometry method is tolerance in 40 CFR part 180 for
and raw agricultural commodities after used to measure and evaluate the residues of the insecticide
harvest under 40 CFR 180.910. The chemical sulfometuron-methyl. Contact: pyrifluquinazon (1-acetyl-1,2,3,4-
petitioner believes no analytical method RD. tetrahydro-3-[(3-pyridylmethyl)amino]-
is needed because it is not required for 3. PP 6F8519. EPA–HQ–OPP–2017– 6-[1,2,2,2-tetraflouro-1-(trifluoromethyl)
an exemption from the requirement of a 0211. Syngenta Crop Protection, LLC, ethyl]quinazolin-2-one) in or on
tolerance. Contact: RD. P.O. Box 18300, Greensboro, NC 27419, imported tea at 20 parts per million
7. PP IN–11048. (EPA–HQ–OPP– requests to establish a tolerance in 40 (ppm). The analytical method HPLC–
2017–0249). Technology Sciences CFR part 180 for residues of the MS/MS is used to measure and evaluate
Group, 1150 18th Street NW., Suite herbicide S-metolachlor in or on the chemical pyrifluquinazon (1-acetyl-
1000, Washington, DC 20035, on behalf sugarcane at 0.4 parts per million (ppm) 1,2,3,4-tetrahydro-3-[(3-
of Attune Agriculture, LLC, 10552 and sugarcane molasses at 1.5 ppm. A pyridylmethyl)amino]-6-[1,2,2,2-
Philadelphia Road, White Marsh, MD gas chromatography-nitrogen tetraflouro-1-(trifluoromethyl)ethyl]
21162, requests to establish an phosphorus detection (GC/NPD) method quinazolin-2-one) and IV–01 (3-
exemption from the requirement of a is used to measure and evaluate the [(pyridine-3-ylmethyl)amino]-6-[1,2,2,2-
tolerance for residues of konjac mannan chemical S-metolachlor. Contact: RD. tetrafluoro-1-(trifluoromethyl) etyl]-3,4-
(CAS Reg. No. 37220–17–0) when used 4. PP 6F853. EPA–HQ–OPP–2017– dihydro-1H-quinaolin-2-one). Contact:
as an inert ingredient (thickener) in 0169. Makhteshim Agan of North RD.
pesticide formulations applied to America (d/b/a ADAMA, 3120
Highlands Blvd., Suite 100, Raleigh, NC Authority: 21 U.S.C. 346a.
growing crops only under 40 CFR
180.920. The petitioner believes no 27604), requests to establish a tolerance Dated: July 26, 2017.
analytical method is needed because it in 40 CFR part 180 for residues of the Delores Barber,
is not required for an exemption from nematicide, fluensulfone, in or on fruit, Director, Information Technology and
the requirements of a tolerance. Contact: pome, crop group 11–10 at 0.3 ppm; Resources Management Division, Office of
RD. fruit, stone crop group 12–12 at 0.06 Pesticide Programs.
8. PP IN–11062. (EPA–HQ–OPP– ppm; small fruit vine climbing subgroup [FR Doc. 2017–19692 Filed 9–14–17; 8:45 am]
2017–0351). InvisiDex, Inc., 1129 13–07D at 0.5 ppm; grape, raisin at 0.8 BILLING CODE 6560–50–P
Maricopa HWY #217, Ojai, CA 93023, ppm; nut, tree, crop group 14–12 at 0.02
requests to establish an exemption from ppm; almond, hulls at 3.0 ppm;
the requirement of a tolerance for sugarcane at 0.03 ppm; sugarcane and ENVIRONMENTAL PROTECTION
residues of the deoxyribonucleic acids molassess at 0.2 ppm, and inadvertent AGENCY
(CAS No. 9006–49–2) when used as an tolerance for residues of fluensulfone,
inert ingredient (chemical identifier/ including its metabolites and [EPA–HQ–OW–2016–0438; FRL–9967–69–
molecular marker) at a concentration of degradates, in or on (10-month plant- OW]
not more than one part per million back interval): Grain, cereal, crop group
(ppm) by weight in pesticide 15 at 0.03 ppm; forage, fodder and straw Request for Public Comments To Be
formulations applied to growing crops of cereal grains, crop group 16 at 2 ppm; Sent to EPA on Peer Review Materials
and raw agricultural commodities after (90-day plant-back interval): Wheat, To Inform the Safe Drinking Water Act
harvest under 40 CFR 180.910. The grain at 0.06 ppm; barley, grain at 0.06 Decision Making on Perchlorate
petitioner believes no analytical method ppm; buckwheat, grain at 0.06 ppm; oat, AGENCY: Environmental Protection
is needed because it is not required for grain at 0.06 ppm; teosinte, grain at 0.06 Agency (EPA).
an exemption from the requirement of a ppm; wheat, bran at 0.10 ppm; barley,
bran at 0.10 ppm; wheat, middlings at ACTION: Notice of request for public
tolerance. Contact: RD.
0.07 ppm; wheat, shorts at 0.08 ppm; comment.
New Tolerances for Non-Inerts
wheat, germ at 0.07 ppm; wheat, straw SUMMARY: The U.S. Environmental
1. PP 6E8526. (EPA–HQ–OPP–2017– at 4 ppm; barley, straw at 4 ppm; oat, Protection Agency (EPA) is announcing
0288). Valent BioSciences LLC, 870 straw at 4 ppm; wheat, forage at 4 ppm; the release of materials for public
Technology Way, Libertyville, IL 60048, oat, forage at 4 ppm; wheat, hay at 8 comment. These materials will undergo
requests to establish a tolerance in 40 ppm; barley hay at 8 ppm; and oat, hay expert peer review in support of EPA’s
CFR part 180 for residues of the plant at 8 ppm. The LC–MS/MS is used to Safe Drinking Water Act decision
regulator 6-benzyladenine in or on measure and evaluate the chemical making for perchlorate. This request is
avocado at 0.05 parts per million (ppm). 3,4,4-trifluoro-but-3-ene-1-sulfonic acid. one of two Federal Register notices
Liquid chromatography with mass- Contact: RD. being published concurrently, seeking
selective (MS/MS) detection is used to 5. PP 7E8571. (EPA–HQ–OPP–2017–
public comment on two separate sets of
measure and evaluate the chemical 6- 0291). Syngenta Crop Protection, LLC,
peer review materials. This notice
benzyladenine. Contact: BPPD. P.O. Box 18300, Greensboro, NC 27419,
2. PP 6E8529. (EPA–HQ–OPP–2017– requests comments (to be sent to EPA)
requests to establish a tolerance in 40
0194). E. I. du Pont de Nemours and on a draft report entitled ‘‘Draft Report:
CFR part 180 for residues of the
Company, 974 Centre Road, Proposed Approaches to Inform the
herbicide, diquat-dibromide, in or on
Wilmington, Delaware 19805, requests Derivation of a Maximum Contaminant
Crop Group 6C (Dried shelled pea and
to establish a tolerance in 40 CFR part Level Goal for Perchlorate in Drinking
bean (except soybean)) at 0.08 parts per
180 for residues of the herbicide Water’’ (draft MCLG Approaches
million (ppm). The Method
mstockstill on DSK30JT082PROD with NOTICES
sulfometuron-methyl, benzoic acid, 2- Report). The companion notice requests
GRM012.03A is used to measure and
[[[[(4,6-dimethyl-2-pyrimidinyl) comments (to be sent to EPA’s
evaluate the chemical residues of diquat
amino]carbonyl]amino]sulfonyl]-, contractor, Versar, Inc.) on an interim
dibromide in commodities. Contact: RD.
methyl ester in or on sugarcane, cane; 6. PP 7E8578. (EPA–HQ–OPP–2011– list of peer reviewers and draft charge
sugarcane, molasses; and sugarcane, 0971). Nichino America, Inc., 4550 questions.
sugar, refined at 0.01 parts per million Linden Hill Rd., Suite 501, Wilmington, DATES:Comments must be received by
(ppm). The liquid chromatography with DE 19808, requests to establish a EPA on or before October 30, 2017.
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![43356 Federal Register / Vol. 82, No. 178 / Friday, September 15, 2017 / Notices
panel peer review (see companion Peer Pollution Prevention Division (7511P), containing currently registered active
Review Federal Register notice, main telephone number: (703) 305– ingredients. Pursuant to the provisions
published on September 15, 2017) will 7090; email address: BPPDFRNotices@ of FIFRA section 3(c)(4) (7 U.S.C.
be given a limited opportunity to submit epa.gov, Michael Goodis, Registration 136a(c)(4)), EPA is hereby providing
public comments once the final peer Division (7505P), main telephone notice of receipt and opportunity to
reviewers are selected by Versar, Inc., number: (703) 305–7090; email address: comment on these applications. Notice
the EPA contractor managing this peer RDFRNotices@epa.gov, Steve Knizner, of receipt of these applications does not
review process. Antimicrobials Division (7510P), main imply a decision by the Agency on these
Dated: September 6, 2017. telephone number: (703) 305–7090; applications:
email address: ADFRNotices@epa.gov. 1. EPA Registration Numbers: 100–815,
Michael H. Shapiro,
The mailing address for each contact 100–1406, 100–1407, and 100–1442. Docket
Acting Assistant Administrator, Office of person is: Office of Pesticide Programs,
Water. ID number: EPA–HQ–OPP–2017–0211.
Environmental Protection Agency, 1200 Applicant: Syngenta Crop Protection, LLC,
[FR Doc. 2017–19703 Filed 9–14–17; 8:45 am]
Pennsylvania Ave. NW., Washington, P.O. Box 18300, Greensboro, NC 27419.
BILLING CODE 6560–50–P DC 20460–0001. Active ingredient: S-metolachlor. Product
SUPPLEMENTARY INFORMATION: type: Herbicide. Proposed use: Sugarcane.
Contact: RD.
ENVIRONMENTAL PROTECTION I. General Information 2. EPA Registration Numbers: 264–1137
AGENCY and 264–1169. Docket ID number: EPA–HQ–
A. Does this action apply to me? OPP–2016–0508. Applicant: Bayer
[EPA–HQ–OPP–2017–0008; FRL–9965–38] You may be potentially affected by CropScience, 2 T.W. Alexander Drive,
this action if you are an agricultural Research Triangle Park, NC 27709. Active
Pesticide Product Registration; ingredient: Fluoxastrobin. Product type:
Receipt of Applications for New Uses producer, food manufacturer, or
Fungicide. Proposed uses: Sorghum (seed
pesticide manufacturer. The following treatment) and Wheat (seed treatment).
AGENCY: Environmental Protection list of North American Industrial Contact: RD.
Agency (EPA). Classification System (NAICS) codes is 3. EPA Registration Numbers: 279–3460,
ACTION: Notice. not intended to be exhaustive, but rather 279–3052, and 279–3158. Docket ID Number:
provides a guide to help readers EPA–HQ–OPP–2017–0372. Applicant: FMC
SUMMARY: EPA has received applications determine whether this document Corporation, 2929 Walnut Street,
to register new uses for pesticide applies to them. Potentially affected Philadelphia, PA 19104. Active ingredient:
products containing currently registered entities may include: Clomazone. Product type: Herbicide.
active ingredients. Pursuant to the • Crop production (NAICS code 111). Proposed uses: Cilantro; dill; vegetable,
Federal Insecticide, Fungicide, and • Animal production (NAICS code cucurbit, group 9; rapeseed subgroup 20A;
vegetable, brassica, head and stem, group 5–
Rodenticide Act (FIFRA), EPA is hereby 112).
16; cottonseed subgroup 20C; Chinese
providing notice of receipt and • Food manufacturing (NAICS code broccoli; kohlrabi; bean, dry; bean, succulent;
opportunity to comment on these 311). and the stalk and stem vegetable subgroup
applications. • Pesticide manufacturing (NAICS 22A, except kohlrabi. Contact: RD.
code 32532). 4. EPA Registration Number: 6836–378.
DATES: Comments must be received on
Docket ID number: EPA–HQ–OPP 2017–
or before October 16, 2017. B. What should I consider as I prepare
0348. Applicant: Lonza Inc., 90 Boroline
ADDRESSES: Submit your comments, my comments for EPA? Road, Allendale, NJ 07401. Active ingredient:
identified by the Docket Identification 1. Submitting CBI. Do not submit this Sodium Pyrithione. Product type: Materials
(ID) Number and the File Symbol of information to EPA through Preservative. Proposed use: Dishwasher rinse
interest as shown in the body of this regulations.gov or email. Clearly mark aid. Contact: AD.
document, by one of the following the part or all of the information that 5. EPA File Symbol: 46197–E. Docket ID
methods: number: EPA–HQ–OPP–2017–0232.
you claim to be CBI. For CBI Applicant: Technology Sciences Group, Inc.
• Federal eRulemaking Portal: http:// information in a disk or CD–ROM that
on behalf of Kansai Paint Co., Ltd., 1150 18th
www.regulations.gov. Follow the online you mail to EPA, mark the outside of the St. NW., Suite 1000, Washington, DC 20036.
instructions for submitting comments. disk or CD–ROM as CBI and then Active ingredient: Permethrin. Product type:
Do not submit electronically any identify electronically within the disk or Insecticide. Proposed use: Permethrin-treated
information you consider to be CD–ROM the specific information that paint to be applied to walls as a means to kill
Confidential Business Information (CBI) is claimed as CBI. In addition to one mosquitoes. Contact: RD.
or other information whose disclosure is complete version of the comment that 6. EPA Registration Numbers: 62719–144
restricted by statute. includes information claimed as CBI, a and 62719–659. Docket ID number: EPA–
• Mail: OPP Docket, Environmental copy of the comment that does not
HQ–OPP–2016–0650. Applicant:
Protection Agency Docket Center (EPA/ Interregional Research Project No. 4 (IR–4)
contain the information claimed as CBI Project Headquarters, Rutgers, The State
DC), (28221T), 1200 Pennsylvania Ave. must be submitted for inclusion in the University of NJ, 500 College Road East, Suite
NW., Washington, DC 20460–0001. public docket. Information so marked 201, W. Princeton, NJ 08540. Active
• Hand Delivery: To make special will not be disclosed except in ingredient: Isoxaben: N-[3-(1-ethyl-1-
arrangements for hand delivery or accordance with procedures set forth in methylpropyl)-5-isoxazolyl]-2, 6-
delivery of boxed information, please 40 CFR part 2. dimethoxybenzamide and isomers. Product
follow the instructions at http:// 2. Tips for preparing your comments. type: Herbicide. Proposed use: Apples,
www.epa.gov/dockets/contacts.html. bushberry subgroup 13–07B, the fruit, small,
When preparing and submitting your
mstockstill on DSK30JT082PROD with NOTICES
Additional instructions on vine climbing, except fuzzy kiwi fruit,
comments, see the commenting tips at subgroup 13–07F; the nut, tree, group 14–12.
commenting or visiting the docket, http://www.epa.gov/dockets/ Contact: RD.
along with more information about comments.html. 7. EPA Registration Number: 73049–407.
dockets generally, is available at http:// Docket ID number: EPA–HQ–OPP–2017–
www.epa.gov/dockets. II. Registration Applications
0289. Applicant: Valent BioSciences, LLC,
FOR FURTHER INFORMATION CONTACT: EPA has received applications to 870 Technology Way, Libertyville, IL 60048.
Robert McNally, Biopesticides and register new uses for pesticide products Active ingredient: 6-benzyladenine. Product
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Document Created: 2017-09-15 00:18:31
Document Modified: 2017-09-15 00:18:31
| 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 | Notices | |
| Action | Notice of request for public comment. | |
| Dates | Comments must be received by EPA on or before October 30, 2017. | |
| Contact | For additional information concerning the draft MCLG Approaches Report, please contact Samuel Hernandez at U.S. EPA, Office of Ground Water and Drinking Water, Standards and Risk Management Division, (Mail Code 4607M), 1200 Pennsylvania Avenue NW., Washington, DC 20460; telephone: 202-564-1735; or email: [email protected] | |
| FR Citation | 82 FR 43354 |
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