[Federal Register Volume 78, Number 217 (Friday, November 8, 2013)]
[Notices]
[Pages 67142-67144]
[FR Doc No: 2013-26848]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2012-0722; FRL-9902-43]

HHCB (1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8,-
hexamethylcyclopenta[[gamma]]-2-benzopyran) TSCA Risk Assessment;
Notice of Public Meetings and Opportunity To Comment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA's contractor, The Scientific Consulting Group (SCG), Inc.,
has identified a panel of scientific experts to conduct a peer review
of EPA's draft Toxic Substances Control Act (TSCA) chemical risk
assessment, ``TSCA Workplan Chemical Risk Assessment for HHCB.'' EPA
will hold three peer review meetings by web connect and teleconference.
EPA invites the public to register to attend the meetings as observers
and/or speakers providing oral comments during any or all of the peer
review meetings as discussed in this document. The public may also
provide comment on whether they believe the appearance of conflict of
interest exists for any proposed peer review panel expert.

DATES: Meetings. The peer review meetings will be held on Wednesday,
December 4, 2013, from 12:00-2:00 p.m. EST; Thursday, January 9, 2014,
from 10:30 a.m.-3:30 p.m. EST; and Thursday, February 6, 2014, from
10:30 a.m.-12:30 p.m. EST.
    Conflict of interest comments. Comments on the appearance of a
conflict of interest for any proposed peer review panel expert must be
submitted on or before November 29, 2013.
    Comments. Written comments by the public must be submitted on or
before January 16, 2014, to be sure they are contained in the peer
review record and are available to the peer reviewers.
    Registration for meetings. To participate in any of the public peer
review meetings, you must register no later than 11:59 p.m., EST, on
November 29, 2013.

ADDRESSES: Meetings. Meetings will be held via web connect and
teleconferencing. See Unit III.C. in SUPPLEMENTARY INFORMATION.
Registration. See Unit III. in SUPPLEMENTARY INFORMATION.
    Comments. Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2012-0722, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments.
     Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001.
     Hand Delivery: OPPT Document Control Office (DCO), EPA
William Jefferson Clinton Complex East, Rm. 6428, 1201 Constitution
Ave. NW., Washington, DC. Attn: Docket ID Number EPA-HQ-OPPT-2012-0722.
The DCO is open from 8 a.m. to 4 p.m., Monday through Friday, excluding
legal holidays. The telephone number for the DCO is<PHONE_NUMBER>.
Such deliveries are only accepted during the DCO's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2012-0722. EPA's policy is that all comments received will be included
in the docket without change and may be made available online at http://www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through regulations.gov or email. The
regulations.gov Web site is an ``anonymous access'' system, which means
EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an email comment
directly to EPA without going through regulations.gov, your email
address will be automatically captured and included as part of the
comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPPT Docket. The OPPT Docket is located in the EPA Docket
Center (EPA/DC) at Rm. 3334, EPA William Jefferson Clinton Complex
West, 1301 Constitution Ave. NW., Washington, DC. The EPA/DC Public
Reading Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding legal holidays. The telephone number of the
EPA/DC Public Reading Room is<PHONE_NUMBER>, and the telephone number
for the OPPT Docket is<PHONE_NUMBER>. Docket visitors are required to
show photographic identification, pass through a metal detector, and
sign the EPA visitor log. All visitor bags are processed through an X-
ray machine and subject to search. Visitors will be provided an EPA/DC
badge that must be visible at all times in the building and returned
upon departure.

FOR FURTHER INFORMATION CONTACT:
    For technical information contact: Stan Barone, Jr., Risk
Assessment Division (7403M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>    For peer review meeting logistics or registration contact: Susie
Warner, The Scientific Consulting Group (SCG), Inc., 656 Quince Orchard
Rd., Suite 210, Gaithersburg, MD 20878-1409; telephone number: (301)
670-4990, ext. 227; fax number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including those interested in
environmental and human health assessment, the chemical industry,
chemical users, consumer product companies, and members of the public
interested in the assessment of chemical risks. Since others also may
be interested, the Agency has not attempted to describe all the
specific entities that may be affected by this action.

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 submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. Background

    On January 9, 2013, EPA published a document in the Federal
Register (78 FR 1856) (FRL-9375-1) on the availability of five draft
TSCA risk assessments for public comment. The Agency also asked for
nominations for external experts to conduct peer reviews of the draft
TSCA risk assessments, including one entitled, ``TSCA Workplan Chemical
Risk Assessment for HHCB (1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8,-
hexamethylcyclopenta[[gamma]]-2-benzopyran).'' HHCB (CASRN 1222- 05-5)
is one of 83 chemicals identified for review and assessment in EPA's
TSCA Work Plan, which were released on March 1, 2012, at http://www.epa.gov/oppt/existingchemicals/pubs/workplans.html.
    This information is distributed solely for the purpose of pre-
dissemination peer review under applicable information quality
guidelines. This is an external peer review draft assessment and has
not been formally disseminated by EPA. It does not represent and should
not be construed to represent any Agency determination or policy.
    The draft HHCB TSCA risk assessment is being peer reviewed
consistent with guidelines for the peer review of influential
scientific information for scientific assessments. EPA asked a
contractor, SCG, to assemble a panel of experts to evaluate the draft
HHCB TSCA risk assessment report for specific uses of HHCB. SCG
evaluated 4 candidates that were nominated as peer reviewers by the
February 8, 2013 deadline established in the January 9, 2013 Federal
Register document and evaluated over 70 additional experts before
submitting the proposed peer review panel members. The proposed peer
review panel was vetted by the contractor for conflict of interest and
the appearance of bias according to Agency peer review guidance as
detailed in the contract. This proposed peer review panel includes:
Daniel Schlenk (chair), Tom Armstrong, Peter Chapman, William Doucette,
Valerie Forbes, Robert W. Gensmer, Patrick Guiney, Duane Huggett, Shane
Snyder, and Lawrence Whitehead.
    The biographies for the proposed panel members are available in the
docket (docket ID number EPA-HQ-OPPT-2012-0722). The public may provide
comments to this docket on the appearance of a conflict of interest for
any proposed peer review panel member. This comment period on the peer
review panel membership closes on November 29, 2013. The final list of
peer review panel members will be available on the SCG's Web site at
http://www.scgcorp.com prior to the first meeting.
    The peer review panel is responsible for the review of the
scientific and technical merit of the draft HHCB TSCA risk assessment,
which is available through http://www.regulations.gov and at http://www.epa.gov/oppt/existingchemicals/pubs/workplans.html. The peer review
panel will not address potential policy implications or risk management
options that may result from the draft HHCB TSCA risk assessment.
Members of the public may register to attend any or all three meetings
as observers and may also register to offer oral comments on each day
of the meetings. A registered speaker is encouraged to focus on issues
directly relevant to science-based aspects of the draft HHCB TSCA risk
assessment.
    The first peer review meeting on December 4, 2013, will be
dedicated to hearing registered speakers' oral comments on the draft
HHCB TSCA risk assessment and reviewing the charge to the peer
reviewers. Each speaker is allowed between 3-5 minutes, depending on
the number of registered speakers. Given time constraints, a maximum of
30 speakers will be allowed to offer comments. If more than 30 speakers
register to provide oral comments, speakers will be selected by SCG in
a manner designed to optimize representation from all organizations,
affiliations, and present a balance of science issues relevant to the
Agency's TSCA risk assessment. Peer review panel members will have
access to written comments and materials and electronic materials
submitted to the docket by January 16, 2014. Registered observers and
speakers will not be allowed to distribute any written comments or
materials or electronic materials directly to the peer review panel
members. To submit written comments, please follow one of the methods
outlined in ADDRESSES. The public comment period closes on January 16,
2014.
    The second peer review panel meeting on January 9, 2014, will be
devoted to deliberations of the draft HHCB TSCA risk assessment by the
peer review panel, guided by the charge questions to the peer review
panel.
    The third and final peer review panel meeting on February 6, 2014,
will focus on the peer review panel's discussion of its draft HHCB TSCA
risk assessment recommendations to EPA, which will be posted on the
contractor Web site prior to the final peer review meeting. The final
peer review panel report will be prepared by SCG and made available to
the public according to the Agency peer review guidance at http://www.epa.gov/peerreview. EPA will consider SCG's peer review panel
report of the comments and recommendations from the three peer review
meetings, as well as written comments and materials and electronic
materials in the docket at http://www.regulations.gov, as it proceeds
to finalize the HHCB TSCA risk assessment.
    If potential risks are indicated in the revised TSCA risk
assessment following peer review and public comment, the Agency will
take the necessary risk

reduction efforts as warranted. If no risks are identified in the
revised TSCA risk assessment following revision in response to peer
review, the Agency may conclude its work on the chemical being
assessed.

III. How can I request to participate in these meetings?

A. Registration

    To attend the peer review meetings, you must register for the
meeting no later than 11:59 p.m., EST, on November 29, 2013. To
register for the meeting, go to http://www.scgcorp.com/dcm-nmp2013/,
complete the online registration form, and submit the required
information. You may also register through the U.S. Postal Service or
by overnight/priority mail by sending the necessary registration
information (see Unit III.B.) to the SCG Meeting Coordinator, Ms. Susie
Warner. The U.S. Postal Service or overnight/priority mail address is:
The Scientific Consulting Group, Inc., 656 Quince Orchard Rd., Suite
210, Gaithersburg, MD 20878-1409. For questions or additional
information, contact Ms. Warner by: Telephone:<PHONE_NUMBER>, ext.
227; fax:<PHONE_NUMBER>; or email<EMAIL_ADDRESS>Registrations
sent via U.S. Postal Service or overnight/priority mail must be
received no later than 11:59 p.m., EST, on November 29, 2013. There
will be no on-site registration, so members of the public who do not
register by 11:59 p.m., EST, on November 29, 2013, using one of the
methods described in this unit, may not receive web access information
in time to attend the first peer review meeting.

B. Required Registration Information

    Members of the public may register to attend any or all three
meetings as observers, or register to speak if planning to offer oral
comments during the scheduled public comment session of a meeting. To
register for the meetings online or by mail, you must provide your full
name, organization or affiliation, and contact information. You must
also indicate which meetings you plan to attend and if you would like
to speak during the scheduled public comment session of a meeting. If
you register to speak, you must also indicate if you have any special
requirements related to your oral comments (e.g., translation).
    If you indicate that you wish to speak, you will be asked to select
one category most closely reflecting the content of your oral comments.
The comment categories related to the charge questions are:
    1. General comments on the risk assessment document;
    2. Comments on the exposure assessment;
    3. Comments on the hazard assessment;
    4. Comments on the risk characterization; or
    5. Other issues.
    Should more than 30 speakers register for a single meeting, these
categories will be used to ensure that a balance of substantive science
issues relevant to the assessment is heard. Additional information on
the selection of speakers and speaking times will be sent out by SCG 3
days prior to each peer review meeting to all individuals registered to
speak.
    To accommodate as many registered speakers as possible, registered
speakers may present oral comments only, without visual aids or written
material. Peer review panel members will have access to any written
comments and materials and electronic materials previously submitted to
the docket. Registered observers and speakers will not be allowed to
distribute any written comments and materials or electronic materials
directly to the peer review panel members.

C. Web Meeting Access

    Each peer review meeting will be held via web connect and
teleconferencing. SCG will provide all registered participants with
information on how to participate in advance of the first peer review
meeting.

List of Subjects

    Environmental protection, Chemicals, Peer review, Risk assessments,
HHCB, Fragrances.

    Dated: October 31, 2013.
Jeff Morris,
Acting Director, Office of Pollution Prevention and Toxics.
[FR Doc. 2013-26848 Filed 11-7-13; 8:45 am]
BILLING CODE 6560-50-P


Comment Info: =================

General Comment:Therapeutic Proteins International, LLC, a manufacturer of novel and biosimilar recombinant therapeutic proteins presents its comments. See the enclosed document.


[Federal Register Volume 83, Number 246 (Wednesday, December 26, 2018)]
[Rules and Regulations]
[Pages 66138-66143]
[FR Doc No: 2018-27908]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0063; FRL-9986-85]

Chlorate; Pesticide Exemptions From Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of chlorate in or on cantaloupe and tomato
under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective December 26, 2018. Objections and
requests for hearings must be received on or before February 25, 2019
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2017-0063, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Anita Pease, Antimicrobials Division
(7510P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2017-0063 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
February 25, 2019. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2017-0063, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online

instructions for submitting comments. Do not submit electronically any
information you consider to be CBI or other information whose
disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Exemptions

    In the Federal Register of December 15, 2017 (82 FR 59604) (FRL-
9970-50), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
4F8325) by ICA Trinova, Inc., 1 Beavers Street, Suite B, Newnan, GA
30263. The petition requested that EPA (1) establish a tolerance for
residues of chlorate in or on cantaloupes at 1.5 parts per million
(ppm), and (2) establish an exemption from the requirement of a
tolerance for residues of chlorate in or on tomatoes. Chlorate is a by-
product of chlorine dioxide, which is generated from the active
ingredient, sodium chlorite, when it is applied via fumigation to
tomatoes and cantaloupes post- harvest, during storage and shipment.
The Agency reviewed submitted residue chemistry data for chlorine
dioxide and chlorate. Given that residues for chlorine dioxide were not
detected and only residues of chlorate were quantified, EPA has
determined that tolerance exemptions are appropriate for chlorate on
both tomatoes and cantaloupes.
    A summary of the petition prepared by ICA Trinova Inc., the
petitioner and registrant is available in the docket, http://www.regulations.gov. Comments were received on the notice of filing;
the Agency's response to these comments is located in Unit IV.B. of
this document. For reasons explained in Unit IV.C., EPA is establishing
an exemption from the requirement of a tolerance for residues of
chlorate in or on cantaloupe and tomato.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement of a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. In making this safety determination, EPA must
take into consideration the factors laid out in section 408(b)(2)(C)
and (D). Specifically, section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue. . . .''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified therein, EPA has reviewed the available scientific data and
other relevant information in support of this action. EPA has
sufficient data to assess the hazards of and to make a determination on
aggregate exposure for chlorate including exposure resulting from the
tolerances established by this action. EPA's assessment of exposures
and risks associated with chlorate follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    Sodium chlorite is the active ingredient that is applied to the
tomatoes and cantaloupe. Once applied, it is activated by a weak acid,
creating gaseous chlorine dioxide. As chlorine dioxide is released, it
also produces the byproduct, chlorate. Based on submitted residue data,
the only residues of the pesticide with the potential for being present
on food commodities are chlorate ions; therefore, the Agency assessed
the safety of aggregate exposure to chlorate in support of this
tolerance action.
    Inorganic chlorates (also known as chlorate salts) encompass all
chlorates including the most abundant salt, sodium chlorate. Toxicology
data relevant to the human health risk assessment are summarized here
and more information about the toxicology data and references can be
found in the Risk Assessment of Tomato and Cantaloupe Fumigation with
Sodium Chlorite 3.2% (chlorine dioxide gas) and Inorganic Chlorates
Human Health Assessment Scoping Document in Support of Registration
Review (Docket ID No. EPA-HQ-OPP-2016-0080-0008) both of which can be
found in the docket for this action at http://www.regulations.gov.
    The hazard database indicates that the thyroid is the primary
target organ of chlorate. Effects observed in subchronic and chronic
toxicity studies show increased thyroid gland weights, colloid
depletion, decreases in triiodothyronine (T3) and thyroxine (T4)
accompanied by increases in thyroid stimulating hormone (TSH),
increased incidence of thyroid follicular cell hypertrophy, thyroid
cell mineralization, follicular cell hyperplasia, and adenomas or
carcinomas in rat studies. Other effects include hematological changes
(hemoglobin concentration, hematocrit, decreased red blood counts
(RBC), and increased reticulocyte counts in females), methemoglobin
concentration changes, and pituitary vacuolization in subchronic
studies starting at doses 10-fold higher than where thyroid effects are
observed.
    In a 2-year drinking water study, there was some evidence of
thyroid gland follicular cell tumors in male rats; however, because
chlorate is not mutagenic and these tumors were only seen at high
doses, chlorate is not likely to be carcinogenic since the chronic
reference dose is below the dose at which alteration of thyroid hormone
homeostasis occurs. Moreover, although there was equivocal and marginal
evidence of increased pancreatic islet carcinoma in female mice, the
Agency has concluded that the selected chronic reference dose is
protective of these potential cancer effects.
    No increased qualitative or quantitative susceptibility in rats or
rabbits was seen in reproduction and developmental studies with
chlorate. Chlorate did not cause developmental effects in rats at doses
up to the limit dose (1,000 mg/kg/day) or in rabbits up to half the
limit dose. Although chlorate has not been evaluated for neurotoxic
effects, acute and subchronic toxicity studies do not indicate any
neurotoxic potential. In a 2-generation reproduction toxicity study,
increased absolute and relative thyroid weight and increased incidence
of slight to moderate hyperactivity of the thyroid glands were reported
in parental and adult F1 males and females at doses 14x higher than the

thyroid effects identified in the adult rat subchronic and chronic
studies.
    The chronic oral toxicity of chlorate was examined in a study
conducted by the National Toxicology Program (NTP). In this study,
Fischer 344 rats (50/sex/group) were exposed to drinking water
containing 0, 125, 1,000, or 2,000 mg/L chlorate for 2 years
(equivalent to 5/5, 35/45, and 75/95 mg/kg/day (males/females)). T4 and
T3 levels were significantly reduced at 35 and 75 mg/kg/day on day 4,
and in 75 mg/kg/day males and females at week 3. TSH was significantly
increased in 35 and 75 mg/kg/day males on day 4 and at week 3, in 35
and 75 mg/kg/day females on day 4, in 75 mg/kg/day females at week 3,
and in 75 mg/kg/day males and females at week 13. At the high dose,
increased incidences of thyroid gland follicular cell carcinoma were
seen in male rats (incidence: 4/47) compared to none in controls, and
of thyroid gland follicular cell adenoma or carcinoma (combined) in
males (incidence: 6/47) and females (incidence: 4/46) compared to one
animal in controls of both sexes. The incidences of thyroid gland
follicular cell hypertrophy were significantly increased in mid- and
high-dose groups of males (33/43 and 40/47 vs. 4/47 in control) and
females (3/47, 7/47, 27/43, 42/46 vs. 3/47 in control).
    In the Agency's 2006 risk assessment for inorganic chlorates,
Revised Inorganic Chlorates. HED Chapter of the Reregistration
Eligibility Decision Document (RED) (Docket ID No. EPA-HQ-OPP-2005-
0507-0004) a lower 95% confidence limit of the benchmark dose (BMDL) of
0.9 mg/kg/day was derived, based on thyroid gland follicular cell
hypertrophy at the 5 mg/kg/day dose from the rat chronic cancer study
(NTP, 2005). EPA has re-considered the data and determined that the
original benchmark dose derived from the study was not sufficiently
supported as an effect level at 5 mg/kg/day, and that the 5 mg/kg/day
dose can be supported as a NOAEL for the study. The point of departure
(POD) for chronic dietary (all populations) exposures is thus the 5 mg/
kg/day dose, based on changes in thyroid hormones (decreased T3,
decreased T4, and increased TSH), and increased incidence of thyroid
follicular cell hypertrophy in male and female rats at the next highest
dose of 35/45 mg/kg/day (males and females respectively).
Mineralization of the thyroid at the 5 mg/kg/day dose level was not
considered to be adverse.
    Specific information on the studies received and the nature of the
adverse effects caused by chlorate as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document titled ``Risk Assessment of Tomato
and Cantaloupe Fumigation with Sodium Chlorite 3.2% (chlorine dioxide
gas) in docket ID number EPA-HQ-OPP-2017-0063.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological POD and levels of concern to use in evaluating
the risk posed by human exposure to the pesticide. For hazards that
have a threshold below which there is no appreciable risk, the
toxicological POD is used as the basis for derivation of reference
values for risk assessment. PODs are developed based on a careful
analysis of the doses in each toxicological study to determine the
NOAEL and the LOAEL. Uncertainty/safety factors are used in conjunction
with the POD to calculate a safe exposure level--generally referred to
as a population-adjusted dose (PAD) or a reference dose (RfD)--and a
safe margin of exposure (MOE). For non-threshold risks, the Agency
assumes that any amount of exposure will lead to some degree of risk.
Thus, the Agency estimates risk in terms of the probability of an
occurrence of the adverse effect expected in a lifetime. For more
information on the general principles EPA uses in risk characterization
and a complete description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints from the documents
referenced in section III, A, for chlorate used for human risk
assessment is shown in Table 1.

                 Table 1--Toxicology Endpoints for Use in Chlorate Human Health Risk Assessments
----------------------------------------------------------------------------------------------------------------
                                                                    RfD, PAD,
                                                  Uncertainty/       level of
      Exposure/scenario            Point of       FQPA safety      concern for        Study and toxicological
                                  departure         factors            risk                   effects
                                                                    assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (All             N/A............  N/A............  N/A............  None of the available studies
 populations, including                                                            provided an endpoint of
 infants and children, and                                                         toxicity attributable to a
 females 13--49 years of age).                                                     single exposure.
Chronic dietary (All           RfD = cPAD =     UF = 30x (10x    NOAEL = 5 mg/kg/ 2 year NTP Study (2005)--rat.
 populations).                  0.17 mg/kg/day.  intraspecies,    day.            MRID 49683134.
                                                 3x                               LOAEL = 35/45 mg/kg/day (male/
                                                 interspecies)                     female) based on changes in
                                                 FQPA SF = 1x.                     thyroid hormones after 3
                                                                                weeks (decreased T4, T3, &
                                                                                increased TSH), increased
                                                                                incidence of thyroid gland
                                                                                follicular cell hypertrophy
                                                                                in males and females (after 3
                                                                                weeks and 2 years).
                              ----------------------------------------------------------------------------------
Cancer (Oral, dermal,             The chronic reference dose will be protective of potential carcinogenicity.
 inhalation).
----------------------------------------------------------------------------------------------------------------
UF = uncertainty factor, FQPA SF = Special FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL =
  lowest observed adverse effect level, PAD = population adjusted dose (a = acute, c = chronic) RfD = reference
  dose, MOE = margin of exposure, LOC = level of concern, N/A = not applicable

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to chlorate, EPA considered exposure under the petitioned-for
tolerance and exemption as well as existing exposures to chlorate. EPA
assessed dietary exposures from chlorate in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern

occurring as a result of a 1-day or single exposure.
    No such effects were identified in the toxicological studies for
chlorate; therefore, a quantitative acute dietary exposure assessment
is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA separately assessed the components of chronic dietary
exposure and then aggregated them for assessing chronic risk. For
existing food crop uses, EPA relied on the assessment of food crop
exposures contained in the 2006 Inorganic Chlorates Reregistration
Eligibility Document. For the petitioned-for use on cantaloupe, EPA
based its assessment on the current version of Dietary Exposure
Evaluation Model--Food Consumption Intake Database--DEEM-
FCIDTM (version 3.16), the food consumption data from the
2003-2008 U.S. Department of Agriculture's National Health and
Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA),
and assumed 100 percent of the cantaloupe crop treated. For the dietary
exposure resulting from use in paper mills, EPA based its exposure
assessment on standard operating procedure screening-level analyses
reported in the registration review human health scoping document,
Inorganic Chlorates Human Health Assessment Scoping Document in Support
of Registration Review.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that a nonlinear RfD approach is appropriate for assessing
cancer risk to chlorate. Cancer risk was assessed using the same
exposure estimates as discussed in Unit III.C.1. ii.
    iv. Anticipated residue and Percent Crop Treated (PCT) information.
EPA used anticipated residue information and PCT estimates in the
dietary food assessment.
    Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data
and information on the anticipated residue levels of pesticide residues
in food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only under the following conditions:
     Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food
consumption in a particular area and the exposure estimate does not
understate exposure for the population in such area. In addition, the
Agency must provide for periodic evaluation of any estimates used. To
provide for the periodic evaluation of the estimate of PCT as required
by FFDCA section 408(b)(2)(F), EPA may require registrants to submit
data on PCT.
    The Agency estimated the PCT for existing uses for the chronic
dietary exposure assessment as follows: corn: <1%; cotton (seed
treatment): 5%; dry beans/peas: <1%; flaxseed: <1%; peppers (chili
peppers): <1%; potatoes; <1%; rice: 1%; safflower (seed treatment): 2%;
sorghum: <1%; soybeans: 5%; soybeans (seed treatment): <1%; sunflower
(seed treatment): <1%; sweet corn: <1%; wheat: 1%; and wheat seed (seed
treatment): <1%. For crops not specified, 100% PCT was used.
    In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and California Department of
Pesticide Regulation (CalDPR) Pesticide Use Reporting (PUR) for the
chemical/crop combination for the most recent 10 years. EPA uses an
average PCT for chronic dietary risk analysis and a maximum PCT for
acute dietary risk analysis. The average PCT figures for each existing
use are derived by combining available public and private market survey
data for that use, averaging across all observations, and rounding up
to the nearest 5%, except for those situations in which the average PCT
is less than 1% or less than 2.5%. In those cases, the Agency would use
less than 1% or less than 2.5% as the average PCT value, respectively.
The maximum PCT figure is the highest observed maximum value reported
within the most recent 10 years of available public and private market
survey data for the existing use and rounded up to the nearest multiple
of 5%, except where the maximum PCT is less than 2.5%, in which case,
the Agency uses less than 2.5% as the maximum PCT.
    2. Dietary exposure from drinking water. The estimated drinking
water concentration (EDWC) was obtained from monitoring data gathered
between 2013-2015 and are contained in the Six-Year Review Technical
Report for Chlorate. For purposes of this assessment, EPA used the
median concentration of 120 micrograms/liter.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). At this time, there
are no longer any registered uses of chlorate that result in non-
occupational, residential exposures.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found inorganic chlorates to share a common mechanism
of toxicity with any other substances, and chlorate does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
chlorate does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general, section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10x, or uses a different

additional safety factor when reliable data available to EPA support
the choice of a different factor.
    2. Prenatal and postnatal sensitivity. No increased qualitative or
quantitative susceptibility in rats or rabbits was seen in reproduction
and developmental studies with chlorate. Chlorate did not cause
developmental effects in rats at doses up to 1,000 mg/kg/day or in
rabbits at doses up to 500 mg/kg/day. No pre- or postnatal
susceptibility was observed in a reproduction study in rats.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1x. That decision is based on the following
findings:
    i. The toxicity database for chlorate is adequate to characterize
the potential for prenatal or postnatal risk for infants and children.
    ii. There is no indication in the available database that chlorate
is a neurotoxicant.
    iii. There was no pre- or postnatal sensitivity or susceptibility
observed in the submitted developmental studies in rats and rabbits and
the 2-generation reproduction study in rats.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary assessment is based on a conservative estimate
of dietary exposures and drinking water monitoring data. These
assessments will not underestimate the exposure and risks posed by
chlorate.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
chlorate is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
chlorate from food and water will utilize 8.4% of the cPAD for children
1-2 years old, the population group receiving the greatest exposure.
There are no residential pesticide uses for chlorate.
    3. Short- and Intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account short- and intermediate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
    Short- and intermediate-term adverse effects were identified;
however, chlorate is not registered for any use patterns that would
result in either short- or intermediate-term residential exposure.
Short- and intermediate-term risk is assessed based on short- and
intermediate-term residential exposure plus chronic dietary exposure.
Because there is no short- or intermediate-term residential exposure
and chronic dietary exposure has already been assessed under the
appropriately protective cPAD (which is at least as protective as the
POD used to assess short- and intermediate-term risk), no further
assessment of short- or intermediate-term risk is necessary, and EPA
relies on the chronic dietary risk assessment for evaluating short- and
intermediate-term risk for chlorate.
    4. Aggregate cancer risk for U.S. population. A cancer aggregate
assessment was not conducted separately, as the chronic aggregate
assessment is protective of cancer for the general U.S. population.
Based on the results of the assessment of chronic risk, the Agency
concludes that exposure to chlorate will not result in a cancer risk of
concern.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to chlorate residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.

B. Response to Comments

    Two comments were received in response to the Notice of Filing,
neither of which raised issues related to the safety of the tolerances
in this action. Because they raise issues outside the scope of this
rulemaking, the Agency is not addressing them here.

C. Revisions to Petitioned-For Tolerances

    The residue data indicate that following use of the pesticide,
there were detectable chlorate residues on the cantaloupe rind,
although none were detected in the edible portions of the cantaloupe,
and that chlorate residues on tomato were indistinguishable from
background levels of chlorate on tomato. Because EPA does not
anticipate use on either commodity to contribute to dietary exposure,
EPA is issuing an exemption from the requirement of tolerance residues
on cantaloupe and tomato. This tolerance exemption covers potential
residues in or on these commodities as a result of direct application
and allows for the shipment of these commodities in interstate
commerce.

V. Conclusion

    An exemption from the requirement of a tolerance is established for
residues of chlorate in or on tomato and cantaloupe.

VI. Statutory and Executive Order Reviews

    This action establishes an exemption from the requirement of a
tolerance under FFDCA section 408(d) in response to a petition
submitted to the Agency. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled ``Regulatory Planning and Review'' (58 FR 51735,
October 4, 1993). Because this action has been exempted from review
under Executive Order 12866, this action is not subject to Executive
Order 13211, entitled ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR
28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of
Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997), nor is it considered a regulatory action under
Executive Order 13771, entitled ``Reducing Regulations and Controlling
Regulatory Costs'' (82 FR 9339, February 3, 2017). This action does not
contain any information collections subject to OMB approval under the
Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it
require any special considerations under Executive Order 12898,
entitled ``Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations'' (59 FR 7629, February 16,
1994).
    Since tolerances and exemptions that are established on the basis
of a petition

under FFDCA section 408(d) do not require the issuance of a proposed
rule, the requirements of the Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: November 30, 2018.
Anita Pease,
Acting Director, Antimicrobial Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Add Sec.  180.1364 to subpart D to read as follows:

Sec.  180.1364  Chlorate; exemption from the requirement of a
tolerance.

    Residues of chlorate in or on tomato and cantaloupe are exempt from
the requirement of a tolerance when resulting from the application of
gaseous chlorine dioxide as a fungicide, bactericide, and antimicrobial
pesticide.

[FR Doc. 2018-27908 Filed 12-21-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 72 (Monday, April 15, 2019)]
[Rules and Regulations]
[Pages 15119-15122]
[FR Doc No: 2019-07442]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 147

[EPA-HQ-OW-2018-0669; FRL-9992-26-OW]

State of North Dakota Underground Injection Control Program;
Class I, III, IV, and V Primacy Revisions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is approving an
application from the State of North Dakota under the Safe Drinking
Water Act (SDWA) to revise the State's existing Underground Injection
Control (UIC) Program for Class I, III, IV, and V injection wells
located within the State, except those in Indian country. North Dakota
has revised its UIC Class I, III, IV, and V program regulations to
transfer primary enforcement authority from the North Dakota Department
of Health to the North Dakota Department of Environmental Quality.

DATES: This final rule is effective on May 15, 2019. The Director of
the Federal Register approved this incorporation by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51 on May 15, 2019. For
judicial purposes, this final rule is promulgated as of April 15, 2019.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-HQ-OW-2018-0669. All documents in the docket are
listed on the http://www.regulations.gov website. Although listed in
the index, some information is not publicly available, e.g.,
Confidential Business Information (CBI) or other information disclosure
of which is restricted by statute. Certain other material, such as
copyrighted material, is not placed on the internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available electronically through http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Kyle Carey, Drinking Water Protection
Division, Office of Ground Water and Drinking Water (4606M), U.S.
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>;
email address: [email protected], or Omar Sierra-Lopez, Underground
Injection Control Unit, Safe Drinking Water Program, Office of Water
Protection (8WP-SUI), U.S. Environmental Protection Agency, Region 8,
1595 Wynkoop Street, Denver, Colorado 80202-1129; telephone number:
(303) 312-7045; fax number:<PHONE_NUMBER>; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. Introduction

    The EPA approved North Dakota's UIC program as meeting the
requirements for primary enforcement responsibility (primacy) for Class
I, III, IV, and V injection wells, under section 1422 of the Safe
Drinking Water Act (SDWA), on September 21, 1984. The State has revised
its UIC Class I, III, IV, and V program statutes and regulations to
transfer this authority from the North Dakota Department of Health to
the North Dakota Department of Environmental Quality.

II. Legal Authorities

    These regulations are being promulgated under authority of sections
1422 and 1450 of the SDWA, 42 U.S.C. 300h-1 and 300j-9.

A. Revision of State UIC Programs

    As required by section 1421 of the SDWA, the EPA promulgated
minimum requirements in the Code of Federal Regulations (CFR) at 40 CFR
part 145 for effective state UIC programs to prevent underground
injection activities that endanger underground sources of drinking
water (USDWs). Under section 1422 of the SDWA, once the EPA approves a
state UIC program, the state has primary enforcement responsibility for
the UIC program. A state may revise its UIC program as provided under
40 CFR 145.32(a) and by following the procedures described under 40 CFR
145.32(b), which require the state to submit a modified program
description, an Attorney General's statement, a Memorandum of
Agreement, or other such documentation as the EPA determines to be
necessary under the circumstances (40 CFR 145.32(b)(1)). States with
approved programs are required to notify the EPA whenever they propose
to transfer all or part of the approved state agency to any other state
agency and to identify any new division of responsibilities among the
agencies involved. Organizational charts required in the state's
original primacy approval package must be revised and resubmitted. The
new agency is not authorized to administer the program until approval
by the Administrator (40 CFR 145.32(c)).
    All revisions to the UIC program are federally enforceable as of
the effective date of the EPA's approval of the respective revision and
40 CFR part 147 codification.
    In the EPA's announcement of its proposed rule in the Federal
Register on December 4, 2018, Table 1 in the proposed amendment to 40
CFR part 147 indicated a State effective date of 2018 for the revisions
to the North Dakota Century Code and North Dakota Administrative Code.
In the final rule, the EPA is revising Sec.  147.1751(a) to identify
2019 as the effective date of the statute and regulations that North
Dakota submitted to the EPA in its program revision submission. The
revised statute specified in Sec.  147.1751(a) was enacted in 2018 and
will be fully effective in April 2019. The revised regulations in Sec.
147.1751(a) were promulgated in 2018 and became effective on January 1,
2019.
    Consistent with the EPA Guidance 34, Guidance for Review and
Approval of State Underground Injection Control (UIC) Programs and
Revisions to Approved State Programs, the EPA considers state-initiated
program revisions to transfer all or part of any program from the
approved authority to another state agency as substantial program
revisions. Under the EPA's regulations, this means that there was an
opportunity for public comment and to request a public hearing (40 CFR
145.32(b)(2)).

B. Indian Country

    The EPA's approval of North Dakota's application to transfer its
SDWA UIC Class I, III, IV, and V primary enforcement authority from the
North Dakota Department of Health to the North Dakota Department of
Environmental Quality does not extend to Indian lands. Pursuant to the
EPA's UIC regulations at 40 CFR 144.3, Indian lands ``means `Indian
country' as defined in 18 U.S.C. 1151.'' As defined in 18 U.S.C. 1151,
Indian country generally includes lands within the exterior boundaries
of the following Indian reservations located within North Dakota: The
Fort Berthold Indian Reservation, the Spirit Lake Reservation, the
Standing Rock Sioux Reservation, and the Turtle Mountain Reservation;
any land held in trust by the United States for an Indian tribe; and
any other areas that are Indian country within the meaning of 18 U.S.C.
1151. The EPA, or eligible Indian tribes, as appropriate, will retain
responsibilities under the SDWA UIC program for Class I, III, IV, and V
injection wells in Indian country.

III. North Dakota's Application

A. Notice of Completion

    On September 18, 2018, the EPA received a complete program revision
package from the State of North Dakota, requesting approval of its
revised UIC regulations for Class I, III, IV, and V injection wells, to
transfer primary enforcement authority from the North Dakota Department
of Health to the North Dakota Department of Environmental Quality. The
EPA has determined that the application contains all the required
elements.
    The UIC program revision package from the State of North Dakota
includes revised versions of: (1) The description of the State's UIC
program (40 CFR 145.23); (2) copies of all applicable State statutes,
regulations, and forms (40 CFR 145.22(a)(5)); (3) the Attorney
General's statement that the State has adequate legal authority to
carry out the program described and to meet the requirements of 40 CFR
part 145; and (4) the Memorandum of Agreement between the State of
North Dakota and the EPA's Region 8 Administrator (40 CFR 145.25).

B. Public Participation Activities Conducted by the State of North
Dakota

    On April 12, 2018, the North Dakota Department of Environmental
Quality provided public notice of its intent to amend and adopt North
Dakota's 1422 Underground Injection Control Rules. The Department
published the notice in 52 North Dakota newspapers. The Department
accepted written comments on the proposed rule changes between April
12, 2018 and May 31, 2018. The Department received no comments. The
Department held a public hearing regarding the UIC rules on March 21,
2018. There were no attendees.

C. Public Participation Activities Conducted by the EPA

    On December 4, 2018, the EPA published a public notice in the
Bismarck Tribune announcing the Agency's proposed approval, request for
public comment, and notice of a public hearing to be held, if requested
within 30 days, on January 8, 2019, and posted it on the EPA Region 8's
website at: https://www.epa.gov/uic/underground-injection-control-epa-region-8-co-mt-nd-sd-ut-and-wy.
    The EPA received three comments in response to the Agency's
proposed rule. Further information regarding the comments can be found
in the docket for this action under Docket ID No. EPA-HQ-OW-2018-0669.
The EPA did not receive a request for a public hearing; as a result,
the EPA announced that no public hearing would be held.

IV. The EPA's Final Action

A. What is the EPA finalizing in this action?

    In this final rule, the EPA is approving the State of North
Dakota's application to transfer its Class I, III, IV, and V primary
enforcement authority from the North Dakota Department of Health to the
North Dakota Department of Environmental Quality and to make conforming
changes to its regulations to reflect such transfer. Regulations under
40 CFR part 147 set forth the applicable UIC programs for each of the
states. This rule updates 40 CFR part 147, subpart JJ, to reflect the
transfer of authority.
    The supporting documents for this final rule are part of the public
record in the EPA's Docket No. EPA-HQ-OW-2018-0669. This action amends
40 CFR part 147, subpart JJ, to incorporate by reference the revised
EPA-approved State statutes and regulations. The EPA will continue to
administer its UIC program for Class I, III, IV, and V injection wells
in Indian country.
    The EPA will continue to oversee the State of North Dakota's
administration of UIC Class I, III, IV, V, and VI programs as
authorized under the SDWA. Part of the EPA's oversight responsibility
will require State quarterly reports of non-compliance and annual UIC
performance reports pursuant to 40 CFR 144.8. The Memorandum of
Agreement between the EPA and the State of North Dakota, signed by the
Regional Administrator on September 18, 2018, provides the EPA with the
opportunity to review and comment on all draft permits.

B. What codification decisions is the EPA making in this rule?

    In this rule, the EPA is finalizing the Federal regulatory text
that incorporates by reference the federally authorized North Dakota
UIC program for Class I, III, IV, and V injection wells, except those
in Indian country. In accordance with the requirements of 1 CFR 51.5,
the EPA is finalizing the incorporation by reference of the North
Dakota statutes and regulations described in the amendments to 40 CFR
part 147 set forth below. The EPA has made, and will continue to make,
these documents generally available through www.regulations.gov and at
the U.S. Environmental Protection Agency, Region 8, Library 2nd Floor,
1595 Wynkoop Street, Denver, Colorado 80202-1129. The EPA is revising
the incorporation by reference at 40 CFR 147.1751 with ``EPA-Approved
North Dakota SDWA Sec.  1422 Underground Injection Control Program
Statutes and Regulations for Well Classes I, III, IV, V and VI,'' dated
January 2019.
    The EPA is also revising table 1 to paragraph (a) of Sec.
147.1751, which lists the EPA-approved North Dakota statutes and
regulations contained in the material incorporated by reference at 40
CFR 147.1751.

V. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    This action is not a significant regulatory action and therefore
the EPA did not submit it to the Office of Management and Budget (OMB)
for review.

B. Executive Order 13771: Reducing Regulations and Controlling
Regulatory Costs

    This action is not an Executive Order 13771 regulatory action
because this action is not significant under Executive Order 12866.

C. Paperwork Reduction Act (PRA)

    This action does not impose any new information collection burden
under the PRA. The OMB has previously approved the information
collection activities contained in the existing regulations and has
assigned OMB control number 2040-0042. Reporting or record-keeping
requirements will be based on the State of North Dakota's UIC
regulations, and the State of North Dakota is not subject to the PRA.

D. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA. In
making this determination, the impact of concern is any significant
adverse economic impact on small entities. An agency may certify that a
rule will not have a significant economic impact on a substantial
number of small entities if the rule relieves regulatory burden, has no
net burden, or otherwise has a positive economic effect on the small
entities subject to the rule. This rule does not impose any
requirements on small entities as this rule approves the State of North
Dakota's UIC program revisions. We have therefore concluded that this
action will have no net regulatory burden for all directly regulated
small entities.

E. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandate as described in
the

UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments. The action imposes no enforceable duty on any state,
local, or tribal governments or the private sector. The EPA's approval
of the State of North Dakota's program revisions does not constitute a
Federal mandate because there is no requirement that a state establish
UIC regulatory programs and because the program is a state rather than
a Federal program.

F. Executive Order 13132: Federalism

    This action does not have federalism implications. It does not have
substantial direct effects on the states, on the relationship between
the national government and the states, or on the distribution of power
and responsibilities among the various levels of government.

G. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications as specified in
Executive Order 13175. This action contains no Federal mandates for
tribal governments and does not impose any enforceable duties on tribal
governments. Thus, Executive Order 13175 does not apply to this action.

H. Executive Order 13045: Protection of Children From Environmental
Health & Safety Risks

    The EPA interprets Executive Order 13045 as applying only to those
regulatory actions that concern environmental health or safety risks
that the EPA has reason to believe may disproportionately affect
children, per the definition of ``covered regulatory action'' in
section 2-202 of the Executive Order. This action is not subject to
Executive Order 13045 because it approves the State of North Dakota's
UIC program revisions.

I. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use

    This action is not subject to Executive Order 13211, because it is
not a significant regulatory action under Executive Order 12866.

J. National Technology Transfer and Advancement Act

    This rulemaking does not involve technical standards.

K. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations

    The EPA has determined that this action is not subject to Executive
Order 12898 (59 FR 7629, February 16, 1994) because it does not
establish an environmental health or safety standard. This action
simply approves North Dakota's transfer of its primary enforcement
authority for its Class I, III, IV, and V wells, pursuant to which the
State of North Dakota will be implementing and enforcing a State UIC
regulatory program that is as stringent as the existing Federal
program.

L. Congressional Review Act (CRA)

    This action is subject to the CRA, and the EPA will submit a rule
report to each House of the Congress and to the Comptroller General of
the United States. This action is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 147

    Environmental protection, Incorporation by reference, Indian lands,
Intergovernmental relations, Reporting and recordkeeping requirements,
Water supply.

    Dated: April 8, 2019.
Andrew R. Wheeler,
Administrator.

    For the reasons set out in the preamble, the Environmental
Protection Agency is amending 40 CFR part 147 as follows:

PART 147--STATE, TRIBAL, AND EPA-ADMINISTERED UNDERGROUND INJECTION
CONTROL PROGRAMS

0
1. The authority citation for part 147 is revised to read as follows:

    Authority:  42 U.S.C. 300f et seq.; and 42 U.S.C. 6901 et seq.

0
2. Amend Sec.  147.1751 by:
0
a. Revising the introductory text and paragraph (a);
0
b. Adding the word ``and'' at the end of paragraph (b)(1);
0
c. Removing paragraphs (b)(2) and (3);
0
d. Redesignating paragraph (b)(4) as paragraph (b)(2);
0
e. Revising paragraphs (c), (d), (e), (f), (g), and (h); and
0
f. Adding paragraph (i).
    The revisions and addition read as follows:

Sec.  147.1751  State-administered program--Class I, III, IV, V and VI
wells.

    The UIC Program for Class I, III, IV, and V wells in the State of
North Dakota, except those located on Indian lands, as defined under 40
CFR 144.3, is the program administered by the North Dakota Department
of Environmental Quality, approved by the EPA pursuant to section 1422
of the SDWA. Notification of this approval was published in the Federal
Register on April 15, 2019; the program is effective May 15, 2019. The
UIC Program for Class VI wells in the State of North Dakota, except
those located on Indian lands, is the program administered by the North
Dakota Industrial Commission (NDIC), approved by the EPA pursuant to
section 1422 of the SDWA. Notification of this approval was published
in the Federal Register on April 24, 2018; the effective date of the
NDIC UIC Class VI program is April 24, 2018. The State-administered UIC
programs for Classes I, III, IV, V, and VI consist of the following
elements, as submitted to the EPA in the State's program applications.
    (a) The requirements set forth in the State statutes and
regulations approved by the EPA for inclusion in ``EPA-Approved North
Dakota SDWA Sec.  1422 Underground Injection Control Program Statutes
and Regulations for Well Classes I, III, IV, V and VI,'' dated January
2019, and listed in table 1 to this paragraph (a), are incorporated by
reference and made a part of the applicable UIC program under the SDWA
for the State of North Dakota. The Director of the Federal Register
approves this incorporation by reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. Copies of the material incorporated by
reference in this paragraph (a) may be inspected at the U.S.
Environmental Protection Agency, Region VIII, Library 2nd Floor, 1595
Wynkoop Street, Denver, Colorado 80202-1129. If you wish to obtain this
material from the EPA Regional Office, call<PHONE_NUMBER>. Copies of
this material also may be inspected at the EPA Headquarters Library, in
the Water Docket, at the EPA Docket Center (EPA/DC), EPA WJC West, Room
3334, 1301 Constitution Ave. NW, Washington, DC 20460. If you wish to
obtain this material from the EPA Docket Center, call<PHONE_NUMBER>.
Copies of this material also may be inspected at the National Archives
and Records Administration (NARA). For information on the availability
of this material at NARA, call<PHONE_NUMBER>, or go to
www.archives.gov/federal-register/cfr/ibr-locations.html.

   Table 1 to Paragraph (a)--EPA-Approved North Dakota SDWA Section 1422 Underground Injection Control Program
                         Statutes and Regulations for Well Classes I, III, IV, V and VI
----------------------------------------------------------------------------------------------------------------
                                                                           State
             State citation                      Title/subject        effective date       EPA approval date
----------------------------------------------------------------------------------------------------------------
North Dakota Century Code Sections 38-12- Regulation, Development               1980  September 21, 1984, 49 FR
 01 through 38-12-03.                      and Production of                           37066.
                                           Subsurface Minerals.
North Dakota Century Code Sections 61-28- Control, Prevention and               1989  March 6, 1991, 56 FR 9418.
 02 and 61-28-06.                          Abatement of Pollution of
                                           Surface Waters.
North Dakota Century Code Sections 61-    Safe Drinking Water Act...            2019  April 15, 2019, [insert
 28.1-01 and 61-28.1-12.                                                               Federal Register
                                                                                citation].
North Dakota Administrative Code          Underground Injection                 2019  April 15, 2019, [insert
 Sections 33.1-25-01-01 through 33.1-25-   Control Program.                            Federal Register
 01-18.                                                                                citation].
North Dakota Administrative Code          Subsurface Mineral                    1986  March 6, 1991, 56 FR 9418.
 Sections 43-02-02-01 through 43-02-02-    Exploration and
 50.                                       Development.
North Dakota Administrative Code          Underground Injection                 1984  September 21, 1984, 49 FR
 Sections 43-02-02.1-01 through 43-02-     Control Program.                            37066.
 02.2-19.
North Dakota Century Code Sections 38-22- Carbon Dioxide Underground            2009  April 24, 2018, 83 FR
 01 through 38-22-23.                      Storage.                                    17761.
North Dakota Administrative Code          Control of Oil and Gas                2013  April 24, 2018, 83 FR
 Sections 38-08-16 and 38-08-17.           Resources.                                  17761.
North Dakota Administrative Code          Geologic Storage of Carbon            2013  April 24, 2018, 83 FR
 Sections 43-05-01-01 through 43-05-01-    Dioxide.                                    17761.
 20.
----------------------------------------------------------------------------------------------------------------

* * * * *
    (c) The Memorandum of Agreement for the Class I, III, IV, and V
Underground Injection Control Program between EPA Region 8 and the
North Dakota Department of Environmental Quality, signed by the EPA
Regional Administrator on September 18, 2018.
    (d) The statement of legal authority, ``Class I, III, IV, and V
Underground Injection Control Program, Attorney General's Statement,''
signed by the Assistant Attorney General of North Dakota on July 30,
2018, and the ``Supplement to the Attorney General Statements Relating
to Programs Being Transferred to the North Dakota Department of
Environmental Quality,'' signed by the Assistant Attorney General of
North Dakota on October 23, 2018.
    (e) The Class I, III, IV, and V Underground Injection Control
Program Description and any other materials submitted as part of the
program revision or as supplements thereto.
    (f) The Memorandum of Agreement for the Class VI Underground
Injection Control Program between EPA Region 8 and the North Dakota
Industrial Commission, signed by the EPA Regional Administrator on
October 28, 2013.
    (g) The Memorandum of Understanding for Class VI between the North
Dakota Industrial Commission, Department of Mineral Resources, Oil and
Gas Division and the North Dakota Department of Health, Water Quality
Division Related to the Underground Injection Control Program, signed
on June 19, 2013.
    (h) The statement of legal authority, ``Class VI Underground
Injection Control Program, Attorney General's Statement,'' signed by
the Attorney General of North Dakota on January 22, 2013.
    (i) The Class VI Underground Injection Control Program Description
and any other materials submitted as part of the program revision or as
supplements thereto.

[FR Doc. 2019-07442 Filed 4-12-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 115 (Wednesday, June 15, 2011)]
[Notices]
[Pages 34974-34975]
[FR Doc No: 2011-14759]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

 [Docket No. PR11-114-000]

Regency Intrastate Gas LP; Notice of Filing

    Take notice that on June 7, 2011, Regency Intrastate Gas LP,
(Regency) filed to revise its Operating Statement. Regency states the
modifications are to remove the anchor shipper provisions, which are no
longer applicable, and to add provisions related to the collection of
information from its shippers, as more fully described in the filing.
    Any person desiring to participate in this rate filing must file in
accordance with Rules 211 and 214 of the Commission's Rules of Practice
and Procedure (18 CFR 385.211 and 385.214). Protests will be considered
by the Commission in determining the appropriate action to be taken,
but will not serve to make protestants parties to the proceeding. Any
person wishing to become a party must file a notice of intervention or
motion to intervene, as appropriate. Such notices, motions, or protests
must be filed on or before the date as indicated below. Anyone filing
an intervention or protest must serve a copy of that document on the
Applicant.

Anyone filing an intervention or protest on or before the intervention
or protest date need not serve motions to intervene or protests on
persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 7 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on Friday, June 17, 2011.

    Dated: June 8, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-14759 Filed 6-14-11; 8:45 am]
BILLING CODE 6717-01-P