Synthetic Organic Chemical Manufacturers Association Meeting with Water Permits Division February 17, 2004 Attendees Deborah Nagle, Water Permits Division, OWM Jan Pickrel, Water Permits Division, OWM Greg Schaner, Water Permits Division, OWM Elaine Brenner, Water Permits Division, OWM Linda Boornazian, Water Permits Division, OWM Pat Nevrincean, FMC Joyce McCarty, Attorney for SOCMA Jeff Gunnulfsen, SOCMA Bill Turetsky, ISP Martha Murroy, AeroJet Seth Levine, Cambrex Purpose and Summary of Meeting SOCMA met with Water Permits Division to outline what it views to be the primary issues in the Pretreatment Streamlining Rule. The following summarizes the discussion:

  pH   Linda Boornazian expressed a need for resources to study pH because more data is required to assess impact on integrity to the system. SOCMA supports AMSA's comments in favor of establishing alternative short term exclusions of discharges of pH between 5.0 and 5.5. EPA should not limit this provision to facilities which have continuous pH monitors. SOCMA supports short term relief, such as allowing discharges less than 4.0 for less than five hours per month and less than 60 minutes per day based on 40 CFR 401.17 and Control Authority monitoring and assessment. Linda raised concerns about lack of data that shows these pH values do not cause harm to the POTW and collection system.

  Equivalent Mass Limits   SOCMA members favor clarity of when mass limits can be used, having encountered that permitting authorities are reluctant to use mass limits because of uncertainties about where they can be applied and the intent of applying them. One concern includes that a grab sample of an intermittent flows of high concentration in small quantities may not provide representative results of the overall mass characteristics. SOCMA argued that mass limits conflict with the general goal of pollution prevention and water conservation measures. SOCMA cited example of someone being penalized for water reduction. Linda questioned monetary benefits to small business. SOCMA replied water conservation can provide incentives to encourage pollution prevention activities. On a practical note, increased sampling would provide representative data when flow is variable. Some facilities have essentially been forced into having to, unnecessarily, truck wastewater offsite for disposal due to lack of clarity of permit, when could have discharged to the POTW if the POTW understood how and when to apply mass limits in the permits. An example of a circumstance is for a batch discharge that may have a " spike" ( high concentration value) on one day, while the quality for the rest of the month is more dilute. Linda queried, " Is there a potential concentration that POTW couldn't accommodate?" SOCMA replied that there was not a pass through issue. Jan asked what would the flow basis be to determine mass for batch discharger? SOCMA agreed with the need for some clarity of how to set a flow value that is in everyone's interest. Some plants, however, can't afford to do flow measurements. In other cases, there are standards that would required both a mass [ instantaneous] maximum limit and also an average limit. Some facilities might be able to report a flow based on tank volume, but can't use a meter. Dilution from non categorical wastewater is also problematic. SOCMA says they have examples to show how concentration value can vary with a flow. SOCMA says some of their facilities are interested in this flexibility, while some are not.

  Pollutants Not Present   SOCMA is concerned that OCPSF facilities have been singled out, unnecessarily so, for exclusion from this provision. Most of its members have consistent data. Control Authority has data that show this. SOCMA members consist of two primary types of operations: 1) facilities that produce a suite of products, 2) facilities that essentially are devoted to production of one chemical with no changes. The regulations also establish limitations for 45 pollutants, 24 of which are chlorinated organics which FMC, for example, doesn't have. If dischargers introduce a new chemical into its production, such change in process is required to be reported anyway. Linda asked how likely will a facility change its product line over time. SOCMA replied that such changes would be determined on a cost basis per business. A SOCMA member asked whether OCPSF was excluded in pre proposal drafts of this rule.

  Removal Credits   SOCMA asked why one of the removal credits concepts was in a preproposal draft, but then was not in the published proposal. Elaine responded that some of the options were determined to be available without a regulatory modification. A SOCMA member agreed that some provisions do not need to be addressed within this rulemaking, but that the Removal Credits option of the current regulation is just not an operable program that can provide financial savings to industries in its current mode. For example, in the 2003 Sewage Sludge Proposal EPA didn't agree to study 15 chemicals for inclusion as eligible pollutants for Removal Credits. SOCMA believes the reasoning for not studying these 15 pollutants is unclear; why was the 2003 study's focus so narrow?


[Federal Register Volume 80, Number 179 (Wednesday, September 16, 2015)]
[Notices]
[Pages 55669-55671]
[FR Doc No: 2015-23210]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-75874; File No. SR-ISE-2015-25]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change To Amend the Schedule of Fees

September 10, 2015.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on August 27, 2015, the International Securities Exchange, LLC
(the ``Exchange'' or the ``ISE'') filed with the Securities and
Exchange Commission the proposed rule change, as described in Items I
and II below, which items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The ISE proposes to amend its Schedule of Fees to extend its
Managed Data Access Service program for the sale of a number of real-
time market data products. The text of the proposed rule change is
available on the Exchange's Web site (http://www.ise.com), at the
principal office of the Exchange, and at the Commission's Public
Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of these statements may be examined at
the places specified in Item IV below. The self-regulatory organization
has prepared summaries, set forth in sections A, B and C below, of the
most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    On June 6, 2013 the ISE implemented a temporary Managed Data Access
Service program that established a new pricing and distribution model
for the sale of a number of real-time market data products.\3\ The
Exchange extended this program for an additional six month period on
December 20, 2013,\4\ and then on September 17, 2014 instituted another
temporary program on the same terms for a one year period set to expire
on August 31, 2015.\5\ The Exchange now proposes to extend its current
Managed Data Access Service program for an additional one year period
ending August 31, 2016 so that the Exchange can continue to provide
this alternative delivery option for ISE data feeds.\6\ Managed Data
Access Service is a pricing and administrative option

whereby the ISE assesses fees to Managed Data Access Distributors,\7\
who redistribute market data to Managed Data Access Recipients.\8\
Managed Data Access Distributors are required to monitor the delivery
of the data retransmitted to their clients, and must agree to reformat,
redisplay and/or alter the data feeds prior to retransmission without
affecting the integrity of the data feeds and without rendering any of
the feeds inaccurate, unfair, uninformative, fictitious, misleading, or
discriminatory.
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    \3\ See Securities Exchange Act Release No. 69806 (June 20,
2013), 78 FR 38424 (June 26, 2013) (ISE-2013-39). The Exchange also
offers a similar Managed Data Access Service program for its Implied
Volatility and Greeks Feed. See Securities Exchange Act Release No.
65678 (November 3, 2011), 76 FR 70178 (November 10, 2011) (ISE-2011-
67). This filing does not apply to the Managed Data Access Service
program for the Implied Volatility and Greeks Feed, which is a
permanent program.
    \4\ See Securities Exchange Act Release No. 71230 (January 2,
2014), 79 FR 1405 (January 8, 2014) (ISE-2013-74).
    \5\ See Securities Exchange Act Release No. 73276 (October 1,
2014), 79 FR 60545 (October 7, 2014) (ISE-2014-41).
    \6\ The current Managed Data Access Service program provides an
alternative delivery option for the Real-time Depth of Market Raw
Data Feed (``Depth Feed''), the Order Feed, the Top Quote Feed, and
the Spread Feed.
    \7\ A Managed Data Access Distributor redistributes ISE data
feeds and permits access to the information in those data feeds
through a controlled device. A Managed Data Access Distributor can
also redistribute a data feed solution to specific IP addresses,
including an Application Programming Interface (``API'') or similar
automated delivery solutions, with only limited entitlement controls
(e.g., usernames and/or passwords) to a recipient of the
information.
    \8\ A Managed Data Access Recipient is a subscriber to the
Managed Data Access Distributor who receives a reformatted data feed
in a controlled device or at a specific IP address. Market Data
Access Recipients may be Professional or Non-Professional users.
---------------------------------------------------------------------------

    The current fees for the Managed Data Access Service are as
follows:
    The Exchange charges a fee to each Managed Data Access Distributor
of $2,500 per month for the Depth Feed, $1,500 for each of the Top
Quote Feed and Spread Feed, and $1,000 per month for the Order Feed.
The Exchange also charges a fee for each IP address at Managed Data
Access Recipients that receive market data redistributed by a Managed
Data Access Distributor, which is $750 per month for the Depth Feed,
$500 per month for each of the Top Quote Feed and Spread Feed, and $350
per month for the Order Feed.\9\ In addition, the Exchange charges a
controlled device fee for each controlled device permitted to access
market data redistributed by a Managed Data Access Distributor to a
Market Data Access Recipient that is a Professional user,\10\ which is
$50 per month for the Depth Feed, $20 per month for the Top Quote Feed,
$25 per month for the Spread Feed, and $10 per month for the Order
Feed.\11\ Finally, the Exchange charges a controlled device fee of $5
per month for each controlled device permitted to access information in
the Depth Feed redistributed by a Managed Data Access Distributor to a
Market Data Access Recipient that is a Non-Professional user.\12\ For
each of the above ISE data feeds, Market Data Access Distributors are
subject to a minimum fee, which is $5,000 per month for the Depth Feed,
$3,000 per month for each of the Top Quote Feed and Spread Feed, and
$2,000 per month for the Order Feed.
---------------------------------------------------------------------------

    \9\ This fee is charged per IP address, which covers both
primary and back-up IP addresses at a Managed Data Access Recipient.
    \10\ A ``Professional user'' is an authorized end-user of the
ISE data feeds that has not qualified as a Non-Professional user.
    \11\ A controlled device is any device that a distributor of an
ISE data feed permits to access the information in that data feed.
    \12\ There is no controlled device fee for Non-Professional
users of the Top Quote Feed, Spread Feed, or Order Feed. A ``Non-
Professional user'' is an authorized end-user of the ISE data feeds
who is a natural person and who is neither: (a) Registered or
qualified with the Securities and Exchange Commission, the
Commodities Futures Trading Commission, any state securities agency,
any securities exchange or association, or any commodities or
futures contract market or association; (b) engaged as an
``investment advisor'' as that term is defined Section 202(a)(11) of
the Investment Advisers Act of 1940 (whether or not registered or
qualified under that act); nor (c) employed by a bank or other
organization exempt from registration under Federal and/or state
securities laws to perform functions that would require him/her to
be so registered or qualified if he/she were to perform such
functions for an organization not so exempt.
---------------------------------------------------------------------------

    The Exchange is not proposing to make any changes to the fees
currently charged under the Managed Data Access Service program.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the requirements of the Securities Exchange Act of 1934 (the
``Act''),\13\ and the rules and regulations thereunder that are
applicable to a national securities exchange, including the
requirements of Section 6(b) of the Act.\14\ In particular, the
proposal is consistent with Section 6(b)(5) of the Act,\15\ because is
designed to promote just and equitable principles of trade, remove
impediments to and perfect the mechanisms of a free and open market and
a national market system and, in general, to protect investors and the
public interest. The Exchange believes that the proposed program is
consistent with the protection of investors and the public interest as
the Exchange already runs a Managed Data Access Service program, and is
merely proposing to extend this program for an additional one year
period. The Exchange established the Managed Data Access Service as a
temporary program in order to gauge the level of interest in this new
pricing and distribution model, and now wishes to extend this temporary
program so that it may continue to offer an attractive program that
competes with programs offered by other options exchanges.\16\ The
Exchange is constrained in pricing the Managed Data Access Service as
these services are entirely optional, and firms may choose whether or
not to purchase proprietary ISE market data products or to utilize any
specific pricing alternative. Moreover, the program will continue to
provide an opportunity for all distributors and subscribers, both
Professional and Non-Professional, to access the ISE data feeds at a
potentially lower cost.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78f.
    \14\ 15 U.S.C. 78f(b).
    \15\ 15 U.S.C. 78f(b)(5).
    \16\ A number of other exchanges have adopted managed data
access services to distribute their proprietary market data. See
e.g. Securities Exchange Act Release Nos. 63276 (November 8, 2010),
75 FR 69717 (November 15, 2010) (SR-NASDAQ-2010-138); and 69182
(March 19, 2013), 78 FR 18378 (March 26, 2013) (SR-PHLX-2013-28).
ISE also offers managed data access service on a permanent basis for
the ISE Implied Volatility and Greeks Feed. See supra note 3.
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    In accordance with Section 6(b)(8) of the Act,\17\ the Exchange
does not believe that the proposed rule change will impose any burden
on intermarket or intramarket competition that is not necessary or
appropriate in furtherance of the purposes of the Act. To the contrary,
the Exchange believes that the proposed rule change will promote
competition as it extends a program that provides an attractive
alternative delivery model for ISE market data that is similar to
programs in place on other options exchanges. The vigor of competition
for market data is significant and the Exchange believes that this
proposal clearly evidences such competition. ISE proposes to continue
to offer this optional Managed Access Data Service in order to keep
pace with changes in the industry and evolving customer needs.
---------------------------------------------------------------------------

    \17\ 15 U.S.C. 78f(b)(8).
---------------------------------------------------------------------------

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the proposed rule change does not (i) significantly affect
the protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative for 30
days from the date on which it was filed, or such shorter time as the
Commission may designate if consistent with the protection of

investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act \18\ and Rule 19b-
4(f)(6) thereunder.\19\
---------------------------------------------------------------------------

    \18\ 15 U.S.C. 78s(b)(3)(A).
    \19\ 17 CFR 240.19b-4(f)(6). As required under Rule 19b-
4(f)(6)(iii), the Exchange provided the Commission with written
notice of its intent to file the proposed rule change, along with a
brief description and the text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission.
---------------------------------------------------------------------------

    The Exchange has asked the Commission to waive the 30-day operative
delay so that the proposal may become operative immediately upon
filing. The Exchange stated that waiver of the operative delay will
permit the Exchange to continue to provide access to subscribers
interested in the Managed Data Access Service program. The Commission
believes that waiving the 30-day operative delay is consistent with the
protection of investors and the public interest. Therefore, the
Commission hereby waives the operative delay and designates the
proposed rule change operative upon filing.\20\
---------------------------------------------------------------------------

    \20\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-ISE-2015-25 on the subject line.

Paper Comments

     Send paper comments in triplicate to Brent J. Fields,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-ISE-2015-25. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-ISE-2015-25, and should be
submitted on or before October 7, 2015.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\21\
---------------------------------------------------------------------------

    \21\ 17 CFR 200.30-3(a)(12).
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Robert W. Errett,
Deputy Secretary.
[FR Doc. 2015-23210 Filed 9-15-15; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 98 (Friday, May 20, 2022)]
[Notices]
[Pages 31090-31091]
[FR Doc No: 2022-10532]

Federal Register / Vol. 87, No. 98 / Friday, May 20, 2022 / Notices

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0571]

Ortho-phthlates for Food Contact Use; Request for Information

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice; request for information.

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SUMMARY: The Food and Drug Administration (FDA or we) is opening a
docket to obtain data and information on the use of ortho-phthalates
(or ``phthalates'') for food contact applications. Specifically, FDA is
seeking scientific data and information on current uses, use levels,
dietary exposure, and safety data of certain ortho-phthalates. The
purpose of this request is to provide FDA with all sources of relevant
information to support our review of the current use levels and safe
use of these ortho-phthalates in food contact applications.

DATES: Submit either electronic or written comments and scientific data
and information by July 19, 2022.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before July 19, 2022. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of July 19, 2022. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2022-N-0571 for ``Ortho-phthalates for Food Contact Use; Request
for Information.'' Received comments, those filed in a timely manner
(see ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review
this copy, including the claimed confidential information, in our
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information to be made publicly available, you can provide
this information on the cover sheet and not in the body of your
comments and you must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Jessica Urbelis, Center for Food
Safety and Applied Nutrition (HFS-275), Food and Drug Administration,
5001 Campus Dr., College Park, MD 20740,<PHONE_NUMBER>; or Meadow Platt,
Office of Regulations and Policy (HFS-024), Center for Food Safety and
Applied Nutrition, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

A. Introduction

    Ortho-phthalates may be used as plasticizers for polymers, most
commonly poly (vinyl chloride), to make the polymers less brittle or to
soften them. These polymers are then used in a wide range of products,
such as toys, vinyl flooring and wall covering, detergents, lubricating
oils, food packaging, pharmaceuticals, blood bags and tubing, and
personal care products. Our food additive regulations at parts 175,
176, 177, 178, and 181 (21 CFR parts 175, 176, 177, 178, and 181)
provide for the safe use of certain ortho-phthalates as plasticizers
for packaging used to contact food and for other food contact
applications, such as components of adhesives, resins, lubricants, and
sealants.

B. Recent Petitions

    In the Federal Register of May 20, 2016 (81 FR 31877), we announced
that we had filed a food additive petition (FAP 6B4815) in accordance
with 21 CFR 171.130. The food additive petition (FAP 6B4815) proposed
that we amend or revoke certain food additive regulations under parts
175, 176, 177, and 178 to no longer provide for the food contact use of
specified ortho-phthalates. The petitioners based their petition on the
claim that new evidence demonstrates the use of these ortho-phthalates
in food contact applications is unsafe. Elsewhere in this issue of the
Federal Register, we have published a

final rule in response to FAP 6B4815 denying that petition.
    On April 20, 2016, we received a citizen petition (Docket No. FDA-
2016-P-1171) requesting that we initiate rulemaking to remove the prior
sanctions in part 181 for the following five ortho-phthalates: di(2-
ethylhexyl) phthalate (CAS No. 117-81-7), diethyl phthalate (CAS No.
84-66-2), ethyl phthalyl ethyl glycolate (CAS No. 84-72-0), butyl
phthalyl butyl glycolate (CAS No. 85-70-1), and diisooctyl phthalate
(CAS No. 27554-26-3). FDA defined the term ``prior sanction'' in Sec.
170.3(l) (21 CFR 170.3(l)) as an explicit approval granted with respect
to use of a substance in food prior to September 6, 1958, by FDA or the
United States Department of Agriculture (USDA), pursuant to the FD&C
Act, the Poultry Products Inspection Act, or the Meat Inspection Act.
The term ``prior sanction'' derives from section 201(s)(4) of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321(s)(4)),
which excepts from the definition of a food additive any substance used
in accordance with a sanction or approval granted before September 6,
1958, the date of enactment of the Food Additives Amendment to the FD&C
Act. Before that date, we had approved specific uses of various food-
contact materials or food ingredients by issuing letters and other
statements that, in FDA's view, these substances were ``not considered
unsafe,'' that they did ``not present a hazard,'' or that we ``did not
object to their use.'' The existence of a prior sanction exempts
sanctioned uses from the food additive provisions of the FD&C Act but
not from the other adulteration or the misbranding provisions of the
FD&C Act (Sec.  181.5(b)). The prior sanction exists only for a
specific use of a substance in food and delineates level(s),
condition(s), and product(s) set forth by explicit approval by FDA or
USDA before September 6, 1958 (Sec.  181.5(a)). Some prior sanctioned
substances are codified in part 181. The citizen petition also
requested that we add a new section to 21 CFR part 189 prohibiting the
use of the following eight ortho-phthalates: diisobutyl phthalate (CAS
No. 84-69-5), di-n-butyl phthalate (CAS No. 84-74-2), butyl benzyl
phthalate (CAS No. 85-68-7), dicyclohexyl phthalate (CAS No. 84-61-7),
di-n-hexyl phthalate (CAS No. 84-75-3), diisooctyl phthalate (CAS No.
27554-26-3), di(2-ethylhexyl) phthalate (CAS No. 117-81-7), and
diisononyl phthalate (CAS No. 28553-12-0). We are denying this citizen
petition.
    In the Federal Register of November 14, 2018 (83 FR 56750), we
announced that we had filed a food additive petition (FAP 8B4820)
submitted in accordance with Sec.  171.130. That FAP (8B4820) proposed
to amend parts 175, 176, 177, and 178 to no longer provide for certain
uses of ortho-phthalates on the basis that the use of those ortho-
phthalates in food contact applications has been abandoned. Elsewhere
in this issue of the Federal Register, we have published a final rule
in response to FAP 8B4820 granting that petition and amending parts
175, 176, 177, and 178 to no longer authorize the uses of the subject
ortho-phthalates in food contact applications because those uses have
been permanently and completely abandoned.
    FAP 8B4820 includes the ortho-phthalates that are addressed in FAP
6B4815 except for the following: Diisononyl phthalate (DINP) (CAS No.
28553-12-0), diisodecyl phthalate (DIDP) (CAS No. 26761-40-0), di(2-
ethylhexyl) phthalate (DEHP) (CAS No. 117-81-7), and dicyclohexyl
phthalate (DCHP) (CAS No. 84-61-7). These four phthalates are not
included in the final rule for FAP 8B4820 because the petition does not
claim that their uses have been abandoned. In addition, FAP 8B4820 does
not include diallyl phthalate (CAS No.) 131-17-9. Diallyl phthalate is
only authorized for use in these regulations as a monomer in the
manufacture of polymers and not as a plasticizer.

C. Current Status of Information

    The original safety assessments that resulted in the authorized
uses of ortho-phthalates in food contact applications were based on
exposure and toxicological information and data provided during the
period of 1961 through 1985. As the food supply and packaging market
has changed since that time, the use of ortho-phthalates in food
contact materials has also evolved. Furthermore, the body of available
toxicological information on phthalates has expanded since the food
contact uses of ortho-phthalates were authorized. While FDA is
generally aware of updated toxicological and use information on
phthalates that is publicly available, we are also aware that
stakeholders do not always make such information public. As such, we
request all updated information regarding the food contact uses, use
levels, and dietary exposure and safety data for the ortho-phthalates
listed below that are currently in use in food contact applications. We
may use this information to update the dietary exposure estimates and
safety assessments for the permitted food contact uses of ortho-
phthalates. While we are responding to the food additive petitions and
citizen petition based on the information provided in those petitions
and other relevant and available data, the information we are
requesting may add to our knowledge of ortho-phthalates that remain
authorized for use.

II. Request for Information

    FDA is requesting information on the current food contact uses, use
levels, dietary exposure and safety data on ortho-phthalates currently
used in food contact applications. FDA is not requesting this
information for uses that have been abandoned. Specifically, FDA
requests the following:
    1. Information on any current specific food-contact uses and use
levels for the following ortho-phthalates found in FDA's regulations
(as food additives and/or prior sanctioned substances): Diisononyl
phthalate (DINP, CAS No. 28553-12-0), diisodecyl phthalate (DIDP, CAS
No. 26761-40-0), di(2-ethylhexyl) phthalate (DEHP, CAS No. 117-81-7),
dicyclohexyl phthalate (DCHP, CAS No. 84-61-7), butylphthalyl butyl
glycolate (BPBG, CAS No. 85-70-1), diethyl phthalate (DEP, CAS No. 84-
66-2), ethylphthalyl ethyl glycolate (EPEG, CAS No. 84-72-0) and
diisooctyl phthalate (DIOP, CAS No. 27554-26-3);
    2. Data, analyses, and any other information related to dietary
exposure from the use of ortho-phthalates listed in item 1 currently in
food contact applications;
    3. Safety data for all ortho-phthalates listed in item 1 currently
used in food contact applications; and/or
    4. Information regarding any prior sanctioned uses of ortho-
phthalates not listed in FDA's regulations. This includes documentation
to support the prior sanction and the information requested in items 1
through 3 above on the current use(s), use levels, exposure, and safety
information for any such prior-sanctioned ortho-phthalates currently in
use.

    Dated: May 11, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-10532 Filed 5-19-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 129 (Monday, July 6, 2020)]
[Rules and Regulations]
[Pages 40128-40131]
[FR Doc No: 2020-14393]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0652 and EPA-HQ-OPP-2020-0047; FRL-10011-10]

S-metolachlor; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of S-
metolachlor in or on multiple commodities which are identified and
discussed later in this document. The Interregional Project Number 4
(IR-4) and Syngenta Crop Protection, LLC requested these tolerances
under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective July 6, 2020. Objections and
requests for hearings must be received on or before September 4, 2020,
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 dockets for this action, identified by docket
identification (ID) numbers EPA-HQ-OPP-2019-0652 and EPA-HQ-OPP-2020-
0047, are 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 note that due to the public health emergency, the EPA Docket
Center (EPA/DC) and Reading Room was closed to public visitors on March
31, 2020. Our EPA/DC staff will continue to provide customer service
via email, phone, and webform. For further information on EPA/DC
services, docket contact information and the current status of the EPA/
DC and Reading Room, please visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division
(7505P), 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
Publishing 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 numbers EPA-HQ-OPP-2019-0652 and EPA-HQ-OPP-2020-0047 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 September 4, 2020. 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 numbers EPA-HQ-OPP-2019-0652 and EPA-
HQ-OPP-2020-0047, 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 https://www.epa.gov/dockets/where-send-comments-epa-dockets. Additional instructions on commenting or visiting the docket,
along with more information about dockets generally, is available at
http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of May 8, 2020 (85 FR 27346) (FRL-10008-
38), 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
9E8800) by IR-4, Rutgers, the State University of New Jersey, 500
College Road East, Suite 201 W, Princeton, NJ 08540. The petition
requested that 40 CFR 180.368(a)(2) be amended by establishing
tolerances for residues of the herbicide S-metolachlor, S-2-chloro-N-
(2-ethyl-6-methylphenyl)-N-(2-methoxy-1-methylethyl)acetamide, its R-
enantiomer, and its metabolites, determined as the derivatives, 2-(2-
ethyl-6-methylphenyl)amino-1-propanol and 4-(2-ethyl-6-methylphenyl)-2-
hydroxy-5-methyl-3-morpholinone, calculated as the stoichiometric
equivalent of S-metolachlor, in or on Dillweed at 5 parts per million
(ppm); Dillweed, dried leaves at 9 ppm; Dill, seed at 15 ppm; Rosemary,
dried leaves at 2 ppm and Rosemary, fresh leaves 1.5 ppm. One comment
was received on the notice of filing. EPA's response to this comment is
discussed in Unit IV.C.
    In the Federal Register of March 3, 2020 (85 FR 12454) (FRL-10005-
58), 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
9F8764) by Syngenta Crop Protection, LLC., P.O. Box 18300, Greensboro,
NC 27419. The petition requested that 40 CFR 180.368(a)(2) be amended
by revising the tolerances for residues of the herbicide S-metolachlor,
S-2-chloro-N-(2-ethyl-6-methylphenyl)-N-(2-methoxy-1-
methylethyl)acetamide, its R-enantiomer, and its metabolites,
determined as the derivatives, 2-(2-ethyl-6-methylphenyl)amino-1-
propanol and 4-(2-ethyl-6-methylphenyl)-2-hydroxy-5-methyl-3-
morpholinone, calculated as the stoichiometric equivalent of S-
metolachlor, in or on soybean seed to be 1.0 ppm and grain, aspirated
fractions to be 2.0 ppm. That document referenced a summary of the
petition prepared by Syngenta Crop Protection, LLC., the registrant,
which is available in the docket, http://www.regulations.gov. There
were no comments received in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA is
establishing several tolerances at different levels than petitioned-for
tolerances and revised the commodity definitions for grain, aspirated
fractions and soybean, seed. The reasons for these changes are
explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue . .
. .''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for S-metolachlor including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with S-metolachlor
follows.
    On March 11, 2019, EPA published in the Federal Register a final
rule establishing tolerances for residues of S-metolachlor in or on
several commodities based on the Agency's conclusion that aggregate
exposure to S-metolachlor is safe for the general population, including
infants and children. See (84 FR 8611) (FRL-9983-79). EPA is
incorporating the following portions of that document by reference
here, as they have not changed in the Agency's current assessment of S-
metolachlor tolerances: The toxicological profile and points of
departure, the cancer assessment and conclusion that a nonlinear
reference dose (RfD) approach is appropriate for assessing cancer risk,
the conclusions about cumulative risk, and the Agency's

determination regarding the children's safety factor. Additionally, EPA
is incorporating the assumptions for exposure assessment from the March
11, 2019 final rule, which have not changed except as explained in the
following paragraph.
    EPA's dietary (food and drinking water) exposure assessments have
been updated to include the additional exposure from the new uses of S-
metolachlor on dill and rosemary and the revised use on soybean. EPA
conducted an unrefined chronic dietary (food and drinking water)
exposure and risk assessment that incorporates tolerance-level residue
values, 100% crop treated, and EPA's 2018 default processing factors.
    The estimated drinking water concentrations (EDWCs) of S-
metolachlor and its metabolites for chronic exposures have also been
updated; the new value used for the chronic assessment to assess the
contribution to drinking water is 830 parts per billion (ppb), which is
lower than the previous value of 978 ppb.
    An acute dietary endpoint (i.e., single dose endpoint) for risk
assessment was not identified in the toxicity database for the general
U.S. population or any other subpopulation for S-metolachlor;
therefore, an acute dietary exposure assessment was not conducted.
Chronic dietary risks are below the Agency's level of concern of 100%
of the chronic population adjusted dose (cPAD); they are estimated to
be 19% of the cPAD for all infants less than 1 year old, the group with
the highest exposure.
    There are no proposed new residential uses for S-metolachlor,
although commercial use in residential areas may result in the
following short-term residential exposures that were used in the
Agency's aggregate risk assessment: Post-application dermal exposures
to youth (11 to less than 16 years old) from treated turf, to children
(6 to less than 11 years old) from treated gardens, and to children (1
to less than 2 years old) from treated turf and post-application
incidental oral exposure to children (1 to less than 2 years old) from
treated turf.
    For aggregate risk assessment, exposures to S-metolachlor in food
and drinking water are combined with residential exposures for the
relevant exposure duration period. Because acute, intermediate-term, or
long-term residential exposures are not expected, aggregate acute and
chronic risk is equivalent to the dietary risks, which are below EPA's
level of concern. Moreover, based on the chronic exposure assessment,
which accounts for potential carcinogenicity, EPA does not expect S-
metolachlor to pose a cancer risk. Short-term aggregate risk, which
combines chronic (background) exposures with the expected short-term
post-application exposures mentioned above, yields margins of exposure
(MOEs) ranging from 110 to 1370, which are not of concern because they
exceed EPA's level of concern (MOEs less than or equal to 100).
    Therefore, EPA concludes there is a reasonable certainty that no
harm will result to the general population, or to infants and children
from aggregate exposure to S-metolachlor residues. More detailed
information can be found in the document entitled, ``S-Metolachlor:
Human Health Risk Assessment for Petition for the Establishment of
Tolerances and Registration for Use in/on Rosemary and Dill (PP#9E8800)
and Amended Use in/on Soybean (PP# 9F8764),'' in docket IDs EPA-HQ-OPP-
2019-0652 and EPA-HQ-2020-0047.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodologies are available in the Pesticide
Analytical Manual (PAM) Vol. II for enforcement of S-metolachlor crop
and livestock tolerances. Pesticide regulation section 180.368, lists a
gas chromatography with nitrogen-phosphorus detector (GC/NPD) method
(Method I) for determining residues in/on crop commodities and a gas
chromatography with mass selective detector (GC/MSD) method (Method II)
for determining residues in livestock commodities. These methods
determine residues of metolachlor and its metabolites as either CGA-
37913 or CGA-49751 following acid hydrolysis.
    The methods may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    No maximum residue limits (MRLs) for S-metolachlor have been
established or proposed by Codex.

C. Response to Comments

    There was one comment received on the notice of filing. The comment
stated that IR-4 is trying to get this chemical through during a
pandemic and without public notice. The commenter also stated that this
chemical should not be used on any food products that American's eat.
In response, EPA notes the existing legal framework provided by section
408 of the FFDCA states that tolerances may be set when persons seeking
such tolerances or exemptions have demonstrated that the pesticide
meets the safety standard imposed by that statute. This comment appears
to be directed at the underlying statute and not EPA's implementation
of it; the comment provides no information relevant the Agency's safety
determination.

D. Revisions to Petitioned-For Tolerances

    The Agency is establishing the tolerances for grain, aspirated
fractions and soybean, seed at different levels than the petitioner
requested. For grain, aspirated fractions, EPA calculated the tolerance
level using the highest average field trial (HAFT) residues in
combination with the median processing factor from the submitted
soybean data. This results in a tolerance of 4 ppm rather than the
proposed tolerance of 2.0 ppm. EPA calculated the tolerance level for
soybean, seed using the HAFT residue values from the submitted soybean
data in the Organization for Economic Cooperation and Development
(OECD) MRL calculator. This results in a tolerance of 0.9 ppm rather
than the proposed tolerance of 1.0 ppm. In addition, the commodity
definitions were revised for grain, aspirated fractions and soybean,
seed. Finally, a tolerance for residues in/on soybean, meal at 1.5 ppm
has been added by the Agency based on the submitted soybean data,
because the HAFT residues in combination with the median processing
factor from the submitted data result in a value higher than the
tolerance level for soybean, seed.

V. Conclusion

    Therefore, tolerances are established for residues of S-
metolachlor, S-2-chloro-N-(2-ethyl-6-methylphenyl)-N-(2-methoxy-1-
methylethyl)acetamide, its R-enantiomer, and its metabolites,
determined as the derivatives, 2-(2-ethyl-6-methylphenyl)amino-1-
propanol and 4-(2-ethyl-6-methylphenyl)-2-hydroxy-5-methyl-3-
morpholinone, calculated as the stoichiometric equivalent of S-
metolachlor in or on dill, seed at 15 ppm; dillweed at 5 ppm; dillweed,
dried leaves at 9 ppm; rosemary, dried leaves at 2 ppm; rosemary, fresh
leaves at 1.5 ppm; and soybean, meal at 1.5 ppm. In addition, the
Agency is increasing the tolerances for residues of S-metolachlor in or
on grain, aspirated fractions to be 4 ppm and soybean, seed to be 0.9
ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in
response to petitions 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), such as the tolerances in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
Tribal Governments, on the relationship between the National Government
and the States or Tribal Governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian Tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, 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: June 19, 2020.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. In Sec.  180.368, paragraph (a)(2):
0
i. Add a heading to the table.
0
ii. Add alphabetically the entries ``Dill, seed''; ``Dillweed'' and
``Dillweed, dried leaves''.
0
iii. Revise the entry for ``Grain, aspirated fractions''.
0
iv. Add alphabetically the entries ``Rosemary, dried leaves'';
``Rosemary, fresh leaves'' and ``Soybean, meal''.
0
v. Revise the entry for ``Soybean, seed''.
    The additions and revisions read as follows:

Sec.  180.368  Metolachlor, tolerances for residues.

    (a) * * *
    (2) * * *

                       Table 2 to Paragraph (a)(2)
------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Dill, seed.................................................           15
Dillweed...................................................            5
Dillweed, dried leaves.....................................            9

                                * * * * *
Grain, aspirated fractions.................................            4

                                * * * * *
Rosemary, dried leaves.....................................            2
Rosemary, fresh leaves.....................................          1.5

                                * * * * *
Soybean, meal..............................................          1.5
Soybean, seed..............................................          0.9

                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2020-14393 Filed 7-2-20; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 152 (Wednesday, August 9, 2017)]
[Notices]
[Pages 37205-37206]
[FR Doc No: 2017-16746]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP17-79-000]

Florida Gas Transmission Company, L.L.C.; Notice of Revised
Schedule for Environmental Review of the Wekiva Parkway Relocation
Project

    This notice identifies the Federal Energy Regulatory Commission
staff's revised schedule for the completion of the environmental
assessment (EA) for the Florida Gas Transmission Company, L.L.C.
(Florida Gas) Wekiva Parkway Relocation Project. The first notice of
schedule, issued on June 7, 2017, identified July 28, 2017 as the EA
issuance date. However, due to additional environmental information to
be filed by Florida Gas since issuance of the June 7, 2017 Scheduling
Notice, the Commission staff requires more time to complete our review.
As a result, staff has revised the schedule for issuance of the EA, to
allow for time to incorporate supplemental information into the final
document.

Schedule for Environmental Review

    Issuance of Notice of Availability of EA: September 14, 2017.
    90-day Federal Authorization Decision Deadline: December 13, 2017.
    If a schedule change becomes necessary, an additional notice will
be provided so that the relevant agencies are kept informed of the
project's progress.

Additional Information

    In order to receive notification of the issuance of the EA and to
keep track of all formal issuances and submittals in specific dockets,
the Commission offers a free service called eSubscription
(www.ferc.gov/docs-filing/esubscription.asp).

    Dated: July 27, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-16746 Filed 8-8-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 125 (Thursday, June 28, 2018)]
[Proposed Rules]
[Pages 30380-30382]
[FR Doc No: 2018-13861]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R10-OAR-2018-0060; FRL-9979-99--Region 10]

Air Plan Approval; Washington; Interstate Transport Requirements
for the 2012 PM2.5 NAAQS

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Clean Air Act (CAA) requires each State Implementation
Plan (SIP) to contain adequate provisions prohibiting emissions that
will have certain adverse air quality effects in other states. On
February 7, 2018, the State of Washington made a submission to the
Environmental Protection Agency (EPA) to address these requirements.
The EPA is proposing to approve the submission as meeting the
requirement that each SIP contain adequate provisions to prohibit
emissions that will contribute significantly to nonattainment or
interfere with maintenance of the 2012 annual fine particulate matter
(PM2.5) national ambient air quality standard (NAAQS) in any
other state.

DATES: Comments must be received on or before July 30, 2018.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R10-
OAR-2018-0060 at https://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from Regulations.gov. 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 the disclosure of which 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://www.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Jeff Hunt, Air Planning Unit, Office
of Air and Waste (OAW-150), Environmental Protection Agency, Region 10,
1200 Sixth Ave., Suite 155, Seattle, WA 98101; telephone number: (206)
553-0256; email address: [email protected].

SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean the EPA. This supplementary
information section is arranged as follows:

Table of Contents

I. What is the background of this SIP submission?
II. What guidance or information is the EPA using to evaluate this
SIP submission?
III. The EPA's Review
IV. What action is the EPA taking?
V. Statutory and Executive Order Reviews

I. What is the background of this SIP submission?

    This rulemaking addresses a submission from the Washington
Department of Ecology (Ecology) assessing interstate transport
requirements for the 2012 annual PM2.5 NAAQS. The
requirement for states to make a SIP submission of this type arises
from section 110(a)(1) of the CAA. Pursuant to section 110(a)(1),
states must submit within 3 years (or such shorter period as the
Administrator may prescribe) after the promulgation of a national
primary ambient air quality standard (or any revision thereof), a plan
that provides for the implementation, maintenance, and enforcement of
such NAAQS. The statute directly imposes on states the duty to make
these SIP submissions, and the requirement to make the submissions is
not conditioned upon the EPA taking any action other than promulgating
a new or revised NAAQS. Section 110(a)(2) includes a list of specific
elements that ``[e]ach such plan'' submission must address. The EPA
commonly refers to such state plans as ``infrastructure SIPs.''
Specifically, this rulemaking addresses the requirements under CAA
section 110(a)(2)(D)(i)(I), otherwise known as the ``good neighbor''
provision, which requires SIPs to contain adequate provisions to
prohibit emissions that will contribute significantly to nonattainment
or interfere with maintenance of the NAAQS in any other state.

II. What guidance or information is the EPA using to evaluate this SIP
submission?

    The most recent relevant document was a memorandum published on
March 17, 2016, titled ``Information on the Interstate Transport ``Good

Neighbor'' Provision for the 2012 Fine Particulate Matter National
Ambient Air Quality Standards under Clean Air Act Section
110(a)(2)(D)(i)(I)'' (memorandum). The memorandum describes the EPA's
past approach to addressing interstate transport, and provides the
EPA's general review of relevant modeling data and air quality
projections as they relate to the 2012 annual PM2.5 NAAQS.
The memorandum provides information relevant to the EPA Regional office
review of the CAA section 110(a)(2)(D)(i)(I) ``good neighbor''
provision in infrastructure SIPs with respect to the 2012 annual
PM2.5 NAAQS. This rulemaking considers information provided
in that memorandum.
    The memorandum also provides states and the EPA Regional offices
with future year annual PM2.5 design values for monitors in
the United States based on quality assured and certified ambient
monitoring data and air quality modeling. The memorandum describes how
these projected potential design values can be used to help determine
which monitors should be further evaluated to potentially address
whether emissions from other states significantly contribute to
nonattainment or interfere with maintenance of the 2012 annual
PM2.5 NAAQS at those sites. The memorandum explains that the
pertinent year for evaluating air quality for purposes of addressing
interstate transport for the 2012 PM2.5 NAAQS is 2021, the
attainment deadline for 2012 PM2.5 NAAQS nonattainment areas
classified as Moderate.
    Based on this approach, the potential receptors are outlined in the
memorandum. Most of the potential receptors are in California, located
in the San Joaquin Valley or South Coast nonattainment areas. However,
there is also one potential receptor in Shoshone County, Idaho, and one
potential receptor in Allegheny County, Pennsylvania. The memorandum
also indicates that for certain states with incomplete ambient
monitoring data, additional information including the latest available
data should be analyzed to determine whether there are potential
downwind air quality problems that may be impacted by transported
emissions.
    This rulemaking considers analysis in Washington's submission, as
well as additional analysis conducted by the EPA during review of its
submission. For more information on how we conducted our analysis,
please see the technical support document (TSD) included in the docket
for this action.

III. The EPA's Review

    This rulemaking proposes action on Washington's February 7, 2018,
SIP submission addressing the good neighbor provision requirements of
CAA section 110(a)(2)(D)(i)(I). State plans must address specific
requirements of the good neighbor provisions (commonly referred to as
``prongs''), including:

--Prohibiting any source or other type of emissions activity in one
state from contributing significantly to nonattainment of the NAAQS in
another state (prong one); and
--Prohibiting any source or other type of emissions activity in one
state from interfering with maintenance of the NAAQS in another state
(prong two).

    The EPA has developed a consistent framework for addressing the
prong one and two interstate transport requirements with respect to the
PM2.5 NAAQS in several previous federal rulemakings. The
four basic steps of that framework include: (1) Identifying downwind
receptors that are expected to have problems attaining or maintaining
the relevant NAAQS; (2) identifying which upwind states contribute to
these identified problems in amounts sufficient to warrant further
review and analysis; (3) for states identified as contributing to
downwind air quality problems, identifying upwind emissions reductions
necessary to prevent an upwind state from significantly contributing to
nonattainment or interfering with maintenance of the relevant NAAQS
downwind; and (4) for states that are found to have emissions that
significantly contribute to nonattainment or interfere with maintenance
of the relevant NAAQS downwind, reducing the identified upwind
emissions through adoption of permanent and enforceable measures. This
framework was applied with respect to PM2.5 in the Cross-
State Air Pollution Rule (CSAPR), designed to address both the 1997 and
2006 PM2.5 standards, as well as the 1997 ozone standard.\1\
---------------------------------------------------------------------------

    \1\ Washington was not part of the CSAPR rulemaking. The EPA
approved the Washington SIP as meeting the CAA section
110(a)(2)(D)(i)(I) requirements for the 1997 ozone and 1997
PM2.5 NAAQS on January 13, 2009 (74 FR 1591) and the 2006
PM2.5 NAAQS on July 30, 2015 (80 FR 45429).
---------------------------------------------------------------------------

    In its submission, Ecology generally mirrored the framework
established by the EPA. Specifically: (1) Ecology reviewed past and
current air quality nationwide to identify potential downwind receptors
that may have problems attaining or maintaining the 2012
PM2.5 NAAQS; (2) Ecology identified those western receptors
from the broader nationwide list that may be impacted by Washington for
further review and analysis; (3) Ecology then reviewed air quality
reports, modeling results, designation letters, designation technical
support documents, and available attainment plans to determine if
emissions from Washington may impact these specific areas; (4) Lastly,
Ecology conducted its own independent Hybrid Single Particle Lagrangian
Integrated Trajectory (HYSPLIT) back trajectory modeling for Shoshone
County, Idaho to support the state's conclusion that sources in
Washington are not significantly contributing to this receptor, or
interfering with maintenance of this receptor. From this analysis,
Ecology concluded that Washington does not significantly contribute to
nonattainment or interfere with maintenance of the 2012
PM2.5 NAAQS in any other state.
    As discussed in the TSD for this action, we came to the same
conclusion as the state. In our evaluation, potential downwind
nonattainment and maintenance receptors were identified in other
states. The EPA evaluated these potential receptors to determine first
if, based on review of relevant data and other information, there would
be downwind nonattainment or maintenance problems, and if so, whether
Washington contributes to such problems in these areas. After reviewing
air quality reports, modeling results, designation letters, designation
technical support documents, attainment plans and other information for
these areas, we find there is no contribution sufficient to warrant
additional SIP measures. Therefore, we are proposing to approve the
Washington SIP as meeting CAA section 110(a)(2)(i)(I) interstate
transport requirements for the 2012 PM2.5 NAAQS.

IV. What action is the EPA taking?

    The EPA is proposing to approve Ecology's February 7, 2018,
submission certifying that the Washington SIP is sufficient to meet the
interstate transport requirements of CAA section 110(a)(2)(D)(i)(I),
specifically prongs one and two, as set forth above. The EPA is
requesting comments on the proposed approval.

V. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, the

EPA's role is to approve state choices, provided that they meet the
criteria of the CAA. Accordingly, this action merely approves state law
as meeting federal requirements and does not impose additional
requirements beyond those imposed by state law. For that reason, this
action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866;
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Particulate matter, Reporting
and recordkeeping requirements.

    Dated: June 14, 2018.
Chris Hladick,
Regional Administrator, Region 10.
[FR Doc. 2018-13861 Filed 6-27-18; 8:45 am]
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