Request for Public Comments To Be Sent to EPA on Peer Review Materials To Inform the Safe Drinking Water Act Decision Making on Perchlorate, 43354-43356 [2017-19703]
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43354
Federal Register / Vol. 82, No. 178 / Friday, September 15, 2017 / Notices
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formulations applied to growing crops
and raw agricultural commodities after
harvest under 40 CFR 180.910. The
petitioner believes no analytical method
is needed because it is not required for
an exemption from the requirement of a
tolerance. Contact: RD.
7. PP IN–11048. (EPA–HQ–OPP–
2017–0249). Technology Sciences
Group, 1150 18th Street NW., Suite
1000, Washington, DC 20035, on behalf
of Attune Agriculture, LLC, 10552
Philadelphia Road, White Marsh, MD
21162, requests to establish an
exemption from the requirement of a
tolerance for residues of konjac mannan
(CAS Reg. No. 37220–17–0) when used
as an inert ingredient (thickener) 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 requirements of a tolerance. Contact:
RD.
8. PP IN–11062. (EPA–HQ–OPP–
2017–0351). InvisiDex, Inc., 1129
Maricopa HWY #217, Ojai, CA 93023,
requests to establish an exemption from
the requirement of a tolerance for
residues of the deoxyribonucleic acids
(CAS No. 9006–49–2) when used as an
inert ingredient (chemical identifier/
molecular marker) at a concentration of
not more than one part per million
(ppm) by weight in pesticide
formulations applied to growing crops
and raw agricultural commodities after
harvest under 40 CFR 180.910. The
petitioner believes no analytical method
is needed because it is not required for
an exemption from the requirement of a
tolerance. Contact: RD.
New Tolerances for Non-Inerts
1. PP 6E8526. (EPA–HQ–OPP–2017–
0288). Valent BioSciences LLC, 870
Technology Way, Libertyville, IL 60048,
requests to establish a tolerance in 40
CFR part 180 for residues of the plant
regulator 6-benzyladenine in or on
avocado at 0.05 parts per million (ppm).
Liquid chromatography with massselective (MS/MS) detection is used to
measure and evaluate the chemical 6benzyladenine. Contact: BPPD.
2. PP 6E8529. (EPA–HQ–OPP–2017–
0194). E. I. du Pont de Nemours and
Company, 974 Centre Road,
Wilmington, Delaware 19805, requests
to establish a tolerance in 40 CFR part
180 for residues of the herbicide
sulfometuron-methyl, benzoic acid, 2[[[[(4,6-dimethyl-2-pyrimidinyl)
amino]carbonyl]amino]sulfonyl]-,
methyl ester in or on sugarcane, cane;
sugarcane, molasses; and sugarcane,
sugar, refined at 0.01 parts per million
(ppm). The liquid chromatography with
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tandem mass spectrometry method is
used to measure and evaluate the
chemical sulfometuron-methyl. Contact:
RD.
3. PP 6F8519. EPA–HQ–OPP–2017–
0211. Syngenta Crop Protection, LLC,
P.O. Box 18300, Greensboro, NC 27419,
requests to establish a tolerance in 40
CFR part 180 for residues of the
herbicide S-metolachlor in or on
sugarcane at 0.4 parts per million (ppm)
and sugarcane molasses at 1.5 ppm. A
gas chromatography-nitrogen
phosphorus detection (GC/NPD) method
is used to measure and evaluate the
chemical S-metolachlor. Contact: RD.
4. PP 6F853. EPA–HQ–OPP–2017–
0169. Makhteshim Agan of North
America (d/b/a ADAMA, 3120
Highlands Blvd., Suite 100, Raleigh, NC
27604), requests to establish a tolerance
in 40 CFR part 180 for residues of the
nematicide, fluensulfone, in or on fruit,
pome, crop group 11–10 at 0.3 ppm;
fruit, stone crop group 12–12 at 0.06
ppm; small fruit vine climbing subgroup
13–07D at 0.5 ppm; grape, raisin at 0.8
ppm; nut, tree, crop group 14–12 at 0.02
ppm; almond, hulls at 3.0 ppm;
sugarcane at 0.03 ppm; sugarcane and
molassess at 0.2 ppm, and inadvertent
tolerance for residues of fluensulfone,
including its metabolites and
degradates, in or on (10-month plantback interval): Grain, cereal, crop group
15 at 0.03 ppm; forage, fodder and straw
of cereal grains, crop group 16 at 2 ppm;
(90-day plant-back interval): Wheat,
grain at 0.06 ppm; barley, grain at 0.06
ppm; buckwheat, grain at 0.06 ppm; oat,
grain at 0.06 ppm; teosinte, grain at 0.06
ppm; wheat, bran at 0.10 ppm; barley,
bran at 0.10 ppm; wheat, middlings at
0.07 ppm; wheat, shorts at 0.08 ppm;
wheat, germ at 0.07 ppm; wheat, straw
at 4 ppm; barley, straw at 4 ppm; oat,
straw at 4 ppm; wheat, forage at 4 ppm;
oat, forage at 4 ppm; wheat, hay at 8
ppm; barley hay at 8 ppm; and oat, hay
at 8 ppm. The LC–MS/MS is used to
measure and evaluate the chemical
3,4,4-trifluoro-but-3-ene-1-sulfonic acid.
Contact: RD.
5. PP 7E8571. (EPA–HQ–OPP–2017–
0291). Syngenta Crop Protection, LLC,
P.O. Box 18300, Greensboro, NC 27419,
requests to establish a tolerance in 40
CFR part 180 for residues of the
herbicide, diquat-dibromide, in or on
Crop Group 6C (Dried shelled pea and
bean (except soybean)) at 0.08 parts per
million (ppm). The Method
GRM012.03A is used to measure and
evaluate the chemical residues of diquat
dibromide in commodities. Contact: RD.
6. PP 7E8578. (EPA–HQ–OPP–2011–
0971). Nichino America, Inc., 4550
Linden Hill Rd., Suite 501, Wilmington,
DE 19808, requests to establish a
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tolerance in 40 CFR part 180 for
residues of the insecticide
pyrifluquinazon (1-acetyl-1,2,3,4tetrahydro-3-[(3-pyridylmethyl)amino]6-[1,2,2,2-tetraflouro-1-(trifluoromethyl)
ethyl]quinazolin-2-one) in or on
imported tea at 20 parts per million
(ppm). The analytical method HPLC–
MS/MS is used to measure and evaluate
the chemical pyrifluquinazon (1-acetyl1,2,3,4-tetrahydro-3-[(3pyridylmethyl)amino]-6-[1,2,2,2tetraflouro-1-(trifluoromethyl)ethyl]
quinazolin-2-one) and IV–01 (3[(pyridine-3-ylmethyl)amino]-6-[1,2,2,2tetrafluoro-1-(trifluoromethyl) etyl]-3,4dihydro-1H-quinaolin-2-one). Contact:
RD.
Authority: 21 U.S.C. 346a.
Dated: July 26, 2017.
Delores Barber,
Director, Information Technology and
Resources Management Division, Office of
Pesticide Programs.
[FR Doc. 2017–19692 Filed 9–14–17; 8:45 am]
BILLING CODE 6560–50–P
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
Environmental Protection
Agency (EPA).
ACTION: Notice of request for public
comment.
AGENCY:
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.
SUMMARY:
Comments must be received by
EPA on or before October 30, 2017.
DATES:
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Federal Register / Vol. 82, No. 178 / Friday, September 15, 2017 / Notices
Submit your comments,
identified by Docket ID No. EPA–HQ–
OW–2016–0438 to the Federal
eRulemaking Portal: https://
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
https://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: Hernandez.Samuel@epa.gov.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
mstockstill on DSK30JT082PROD with NOTICES
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, physiologicallybased 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
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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 DoseResponse (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=EPAHQ-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
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43355
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=EPAHQ-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
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43356
Federal Register / Vol. 82, No. 178 / Friday, September 15, 2017 / Notices
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
ENVIRONMENTAL PROTECTION
AGENCY
Pollution Prevention Division (7511P),
main telephone number: (703) 305–
7090; email address: BPPDFRNotices@
epa.gov, Michael Goodis, Registration
Division (7505P), main telephone
number: (703) 305–7090; email address:
RDFRNotices@epa.gov, Steve Knizner,
Antimicrobials Division (7510P), main
telephone number: (703) 305–7090;
email address: ADFRNotices@epa.gov.
The mailing address for each contact
person is: Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001.
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
Pesticide Product Registration;
producer, food manufacturer, or
Receipt of Applications for New Uses
pesticide manufacturer. The following
AGENCY: Environmental Protection
list of North American Industrial
Agency (EPA).
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
ACTION: Notice.
provides a guide to help readers
SUMMARY: EPA has received applications determine whether this document
to register new uses for pesticide
applies to them. Potentially affected
products containing currently registered entities may include:
active ingredients. Pursuant to the
• Crop production (NAICS code 111).
Federal Insecticide, Fungicide, and
• Animal production (NAICS code
Rodenticide Act (FIFRA), EPA is hereby 112).
• Food manufacturing (NAICS code
providing notice of receipt and
311).
opportunity to comment on these
• Pesticide manufacturing (NAICS
applications.
code 32532).
DATES: Comments must be received on
or before October 16, 2017.
B. What should I consider as I prepare
my comments for EPA?
ADDRESSES: Submit your comments,
identified by the Docket Identification
1. Submitting CBI. Do not submit this
(ID) Number and the File Symbol of
information to EPA through
interest as shown in the body of this
regulations.gov or email. Clearly mark
document, by one of the following
the part or all of the information that
methods:
you claim to be CBI. For CBI
• Federal eRulemaking Portal: https:// information in a disk or CD–ROM that
www.regulations.gov. Follow the online you mail to EPA, mark the outside of the
instructions for submitting comments.
disk or CD–ROM as CBI and then
Do not submit electronically any
identify electronically within the disk or
information you consider to be
CD–ROM the specific information that
Confidential Business Information (CBI) is claimed as CBI. In addition to one
or other information whose disclosure is complete version of the comment that
restricted by statute.
includes information claimed as CBI, a
• Mail: OPP Docket, Environmental
copy of the comment that does not
Protection Agency Docket Center (EPA/
contain the information claimed as CBI
DC), (28221T), 1200 Pennsylvania Ave.
must be submitted for inclusion in the
NW., Washington, DC 20460–0001.
public docket. Information so marked
• Hand Delivery: To make special
will not be disclosed except in
arrangements for hand delivery or
accordance with procedures set forth in
delivery of boxed information, please
40 CFR part 2.
follow the instructions at https://
2. Tips for preparing your comments.
www.epa.gov/dockets/contacts.html.
When preparing and submitting your
Additional instructions on
comments, see the commenting tips at
commenting or visiting the docket,
https://www.epa.gov/dockets/
along with more information about
comments.html.
dockets generally, is available at https://
II. Registration Applications
www.epa.gov/dockets.
EPA has received applications to
FOR FURTHER INFORMATION CONTACT:
register new uses for pesticide products
Robert McNally, Biopesticides and
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[EPA–HQ–OPP–2017–0008; FRL–9965–38]
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containing currently registered active
ingredients. Pursuant to the provisions
of FIFRA section 3(c)(4) (7 U.S.C.
136a(c)(4)), EPA is hereby providing
notice of receipt and opportunity to
comment on these applications. Notice
of receipt of these applications does not
imply a decision by the Agency on these
applications:
1. EPA Registration Numbers: 100–815,
100–1406, 100–1407, and 100–1442. Docket
ID number: EPA–HQ–OPP–2017–0211.
Applicant: Syngenta Crop Protection, LLC,
P.O. Box 18300, Greensboro, NC 27419.
Active ingredient: S-metolachlor. Product
type: Herbicide. Proposed use: Sugarcane.
Contact: RD.
2. EPA Registration Numbers: 264–1137
and 264–1169. Docket ID number: EPA–HQ–
OPP–2016–0508. Applicant: Bayer
CropScience, 2 T.W. Alexander Drive,
Research Triangle Park, NC 27709. Active
ingredient: Fluoxastrobin. Product type:
Fungicide. Proposed uses: Sorghum (seed
treatment) and Wheat (seed treatment).
Contact: RD.
3. EPA Registration Numbers: 279–3460,
279–3052, and 279–3158. Docket ID Number:
EPA–HQ–OPP–2017–0372. Applicant: FMC
Corporation, 2929 Walnut Street,
Philadelphia, PA 19104. Active ingredient:
Clomazone. Product type: Herbicide.
Proposed uses: Cilantro; dill; vegetable,
cucurbit, group 9; rapeseed subgroup 20A;
vegetable, brassica, head and stem, group 5–
16; cottonseed subgroup 20C; Chinese
broccoli; kohlrabi; bean, dry; bean, succulent;
and the stalk and stem vegetable subgroup
22A, except kohlrabi. Contact: RD.
4. EPA Registration Number: 6836–378.
Docket ID number: EPA–HQ–OPP 2017–
0348. Applicant: Lonza Inc., 90 Boroline
Road, Allendale, NJ 07401. Active ingredient:
Sodium Pyrithione. Product type: Materials
Preservative. Proposed use: Dishwasher rinse
aid. Contact: AD.
5. EPA File Symbol: 46197–E. Docket ID
number: EPA–HQ–OPP–2017–0232.
Applicant: Technology Sciences Group, Inc.
on behalf of Kansai Paint Co., Ltd., 1150 18th
St. NW., Suite 1000, Washington, DC 20036.
Active ingredient: Permethrin. Product type:
Insecticide. Proposed use: Permethrin-treated
paint to be applied to walls as a means to kill
mosquitoes. Contact: RD.
6. EPA Registration Numbers: 62719–144
and 62719–659. Docket ID number: EPA–
HQ–OPP–2016–0650. Applicant:
Interregional Research Project No. 4 (IR–4)
Project Headquarters, Rutgers, The State
University of NJ, 500 College Road East, Suite
201, W. Princeton, NJ 08540. Active
ingredient: Isoxaben: N-[3-(1-ethyl-1methylpropyl)-5-isoxazolyl]-2, 6dimethoxybenzamide and isomers. Product
type: Herbicide. Proposed use: Apples,
bushberry subgroup 13–07B, the fruit, small,
vine climbing, except fuzzy kiwi fruit,
subgroup 13–07F; the nut, tree, group 14–12.
Contact: RD.
7. EPA Registration Number: 73049–407.
Docket ID number: EPA–HQ–OPP–2017–
0289. Applicant: Valent BioSciences, LLC,
870 Technology Way, Libertyville, IL 60048.
Active ingredient: 6-benzyladenine. Product
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]]>Agencies
[Federal Register Volume 82, Number 178 (Friday, September 15, 2017)]
[Notices]
[Pages 43354-43356]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: https://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 https://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:
Hernandez.Samuel@epa.gov.
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
