SUPPORTING STATEMENT FOR THE

RENEWABLE FUELS STANDARD (RFS2) PROGRAM (Draft)

January 8, 2013

A.	JUSTIFICATION

1.	Identification of the Information Collection

a.	Title:  Renewable Fuels Standard (RFS2) Program, EPA ICR No. 2333.03,
OMB Control Number 2060-0640.

b. 	Short characterization:

	The Energy Policy Act (EPAct) of 2005 amended the Clean Air Act,
section 211(o), and required the existing RFS program.  The existing RFS
program is referred to in this supporting statement as "RFS1". The RFS1
program started in 2006 and was covered by EPA ICR No. 2242.02, OMB
Control Number 2060-0600. Please refer to “Regulation of Fuels and
Fuel Additives: Renewable Fuel Standard Program – Notice of Proposed
Rulemaking” and “Regulation of Fuels and Fuel Additives: Renewable
Fuel Standard Program – Final Rule” (both available in docket number
EPA-HQ-OAR-2005-0161) for a detailed discussion of the RFS1 program”.

	The Energy Independence and Security Act (EISA) of 2007 further amends
the Clean Air Act, section 211(o), and has required EPA to propose new
regulations for renewable fuels.  The new RFS program is referred to in
this supporting statement as "RFS2."  Under RFS2, the volume requirement
and types of renewable fuels are expanded; non-road uses are included
(RFS1 only affected motor vehicle fuel); there are additional types of
waivers and special provisions for renewable fuel types; and EPA will
implement an EPA-Moderating Transaction System (EMTS) for RINs.
Additional parties will be required to register, keep records, and
report.  Please refer to the Final Rule (available in docket number
EPA-HQ-OAR-2005-0161) for a detailed discussion of the RFS2 program.

For compliance purposes, under both RFS1 and RFS2, volumes of renewable
fuel are identified through the use of renewable identification numbers
(RINs) that are initially generated by the producer of the renewable
fuel.  However, under RFS2, there are additional types of RINs and the
volume of RINs traded is expected to be greater.

	This supporting statement provides tables that break down reporting
items by party (e.g. producer, importer, refiner, etc.)  Parties who are
interested in recordkeeping and reporting burden will want to review the
tables containing our estimates carefully.  The RFS2 program includes
provisions for EMTS for RINs, which was not a feature of RFS1.  It also
includes third-party disclosure provisions applicable to biofuel
feedstock producer‘s who were not covered by recordkeeping and
reporting under RFS1.

	The Regulatory Impact Analysis (RIA), which was prepared for the Final
Rule, has been placed in the public docket.  This document was consulted
to provide additional detailed information about the regulated universe
(see Chapter 1 of the draft RIA).  We also considered the actual number
of reporting parties under RFS1 and similar reporting programs.

2.  Need For, and Use of, the Collection

Authority for the Collection

	  SEQ CHAPTER \h \r 1 Sections 114 and 208 of the Clean Air Act (CAA),
42 U.S.C. §§ 7414 and 7542, authorize EPA to require recordkeeping and
reporting regarding enforcement of the provisions of Title II of the
CAA.

	b. 	Practical Utility/Uses of the Data

	The reporting requirements of this regulation will allow EPA to monitor
compliance with the RFS program.

3.  Non-duplication, Consultation, and other Collection Criteria

	a. 	Non-duplication

	  SEQ CHAPTER \h \r 1 Efforts have been made to eliminate duplication
in this information collection.

b. 	Public Notice

	EPA is seeking comment on reporting requirements via the NPRM.  We have
also docketed a copy of our draft ICR supporting statement.

	c. 	Consultations

	We have drawn upon our experience with RFS1 and with similar fuels
regulations to develop the estimates in this supporting statement.
Interested parties may also be interested in reviewing "Chapter 1 –
Industry Characterization" of the draft Regulatory Impact Analysis (RIA)
available in the public docket.

	d. 	Effects of Less Frequent Data Collection

	We have designed the reporting schedule to coincide with existing
reporting deadlines applicable to many of the same parties under such
programs as RFG and anti-dumping and diesel fuel.  Less frequent
collection of data would make it impossible to carry out the provisions
of the CAA and EISA.

	e. 	General Guidelines

	This rule does not exceed any of the OMB guidelines.

	f. 	Confidentiality

	We inform respondents that they may assert claims of business
confidentiality (CBI) for information they submit. Under RFS2, actual
RINs should not be treated as confidential business information under
RFS2, as they are necessary identifiers to accompany renewable fuels.
Any information claimed as confidential will be treated in accordance
with 40 CFR Part 2 and established Agency procedures.  Information that
is received without a claim of confidentiality may be made available to
the public without further notice to the submitter under 40 CFR §
2.203.

g. 	Sensitive Information

	This information collection does not require submission of any
sensitive information.

4.	The Respondents and the Information Requested

	a.	Respondents/with NAICS and SIC Codes

  SEQ CHAPTER \h \r 1 The respondents to this information collection
fall into the following general industry categories:  petroleum
refineries (324110/2911), ethyl alcohol manufacturers (325193/2869),
other basic organic chemical manufacturing (325110/2869), chemical and
allied products merchant wholesalers (426990/5169), petroleum bulk
stations and terminals (422710/5171), petroleum and petroleum products
merchant wholesalers (422720/5172), and other fuel dealers
(454319/5989).

	Using the terminology associated with the RFS2 Final Rule, we have
assumed the following classes of party, with the number of each in
parenthesis:

Producers of renewable fuels (500, of which 300 are biodiesel producers)

Importers (75, of which 20 are biodiesel importers)

Obligated Parties (150)

Parties who own RINs ( 950)

Foreign Refiners (10)

[Note:  The above estimates are derived from the number of registered
parties as of December, 2012, rounded up.  The number of biodiesel
producers is the number registered as of December, 2012, rounded up.]

For biofuel feedstock producers, we have assumed the following classes
of party, with the number of each in parenthesis:

(1,000,000)  out of 10 million plantation and private forest owners in
United States

(30,966 ) foreign biofuel feedstock producers ( Estimated 3% of Domestic
plantation and private forest owners )

[Note:  The above estimates are derived from the following sources:  A
presentation given by Brent Butler, United States Forest Service in
conjunction with the U.S. Department of Agriculture, entitled “Who
Owns America’s Forest?,” dated May, 2008 estimates a 10,000,000
population of plantation and private forest owners.  We have assumed 1
million owners or 10% to participate in RFS2.

The Bureau of Labor Statistics, U.S. Department of Labor, Occupational
Outlook Handbook, 2012-13 Edition, Farmers, Ranchers, and other
Agricultural Managers, on the Internet at   HYPERLINK
"http://www.bls.gov/ooh/management/farmers-ranchers-and -other
agricultural-managers.htm"
http://www.bls.gov/ooh/management/farmers-ranchers-and -other
agricultural-managers.htm  Estimated 1,106,400  persons who claim
farming as an occupation and for our purposes can be possible producers
of feedstock for producers of renewable fuel. We estimated the number of
foreign biofuel feedstock producers to be 30,192 which is 3% of the
total of domestic feedstock producers (i.e., 3% of 1,006,400.)]

	This supporting statement includes estimates reporting involving
biofuel feedstock producers and plantation/private forest owners. These
parties must provide certain information about their feedstock and
lumber byproducts resources to biofuel producers and to EPA upon
request.  The RFS2 final rule contains provisions requiring
recordkeeping/reporting and the mapping of certain plots of land (e.g.
generating a Google map or similar representation), based upon an
aggregate baseline approach. At this stage in the program, this
information is required for foreign biofuel feedstock producers,
domestic plantation/private forest owners and foreign plantation/private
forest owners.  Although we expect that this could lead to future burden
on the part of certain biofuel producers who use croplands and wood
byproducts, we do not expect that the domestic biofuels feedstock
producers or those from Canada will be required to engage in
recordkeeping and reporting activities under this provision at this
time. Therefore, we are providing estimates related to this provision
for the above named biofuels feedstock producers. We expect this to
result in added burden during the three year period covered by this ICR.
 Estimates for future recordkeeping and reporting will be provided when
the recordkeeping and reporting is expected to occur.  See Table Vl:
Biofuels Feedstock Producers.

b.	Information Requested

		A)	Reporting:  The individual reports required from regulated parties
are described in the preamble.  The following reports are required by
the Final Rule:  Annual Compliance Reports (obligated parties only), see
table Vlll:  Biofuels Feedstock Producers, required to provide
information on the land used to provide feedstock to fuel producers, see
table Vl: Quarterly Reports of Biofuels Party requires the submission of
quarterly reports regarding generation and assignment of RINs (producers
and importers only), See Table Vll: and Quarterly RIN Reports
summarizing transactions and activity, and “real time” RIN
transactional activity reporting within EMTS, see table Vllll.
Reporting items include registration of parties engaged in activities
covered by the RFS2 regulation and reporting related to transactions
involving RINs and associated volumes of fuel.

The exact reports filed will depend upon the activity engaged in by the
party. A party must file reports appropriate for each activity it
engages in – for example, if a party is both an exporter of renewable
fuel and a producer of renewable fuel, then that party must file the
reports applicable to both activities.

	In the Final Rule, we establish that “real time” reporting within
EMTS will be construed as within five (5) business days of a reportable
event (e.g. generation and assignment of RINs, transfer of RINs).  This
means that some parties may elect to “batch” real time reports,
similar to how businesses batch credit card transactions at the end of
the day.  We estimate that an average party would report daily,
resulting in 365 instances of reporting in EMTS per year.

Quarterly reports are due as follows:

Quarterly Reporting Schedule for RFS2 Program

Quarter Covered by Quarterly Report	Due Date for Quarterly Report

January - March	May 31

April - June	August 31

July - September	November 30

October - December	February 28

Annual reports are due on February 28 for the preceding year.

For some reports, e.g. involving biofuel feedstock producers the
frequency of reporting is “on occasion” (i.e., when a transaction
requiring disclosure occurs).  As discussed above, for EMTS purpose, we
have assumed one instance of reporting per day for each day of the year,
or 365 instances of reporting).

Tables I - V estimate the recordkeeping and reporting burden by party.
We will provide respondents the opportunity to engage in simplified,
secure, electronic reporting via the Agency's Central Data Exchange
(CDX) and its exchange network protocol.  An attachment explaining the
exchange network protocol is provided with this supporting statement.
Respondents must keep copies of all reports filed for five (5) years.

		B)	Recordkeeping: Respondents must retain underlying records related
to reports they file for five (5) years.  This period is consistent with
other fuels programs and with customary business practices (CBP) for the
industry.  Respondents must transfer volumes of fuel with product
transfer documentation or bills of lading, which is already done in the
course of business.

5.  The Information Collected, Agency Activities, Collection
Methodology, and Information Management

a.	Agency Activities

All reports and registrations will be reviewed by EPA for completeness
and for potential violations.

Potential violations will be referred to enforcement personnel.

Registration numbers will be issued for new registrants.

Contacting reporting parties if there is a problem with their
submission.

b. 	Collection and Methodology and Management

	We anticipate receiving data in a simplified and secure fashion via the
Agency's CDX.  Information claimed as CBI will be stored in
appropriately controlled areas.

c.	Small Entity Flexibility

	This collection will not adversely affect small entities.  The Final
Rule describes flexibility provisions available to small entities.

d.	Collection Schedule

	Registrations are received on a rolling basis, as updates may be sent
in at any time and new parties may enter the regulated industry at any
time.   Reporting is as-needed, monthly, quarterly, and annual.

6.	Estimating the Burden and Cost of Collection

a.	Estimating the Respondent Universe

	We drew upon experience implementing similar regulations among the same
entities to develop estimates of the burden associated with this
collection.

b.	Estimating the Respondent Burden and Cost

	Three labor categories are involved:  managerial (includes legal and
professional review), technical, and clerical. The estimates used the
Bureau of Labor Statistics figures from "National Industry-Specific
Occupational Employment & Wage Estimate “Petroleum and Coal Products
Manufacturing” (May 2011), with a 3% annual inflation factor applied
to bring the values to the present.  Using this method, the following
wages and benefits apply by category:

Wages and Benefits

Managerial    		$67.44   per hour

Technical		$65.56   per hour

Clerical		$22.17   per hour

Doubling for company overhead beyond wages and benefits, and for
convenience, rounding up to the dollar, gives the following rates for
this ICR:

Total Employer Cost

Managerial		$135.00 per hour

Technical		$131.00 per hour

Clerical		$   44.00 per hour

It is assumed that for each hour of activity the mix will be about 0.1
hour managerial, 0.7 hour technical, and 0.2 hour clerical.  This gives
an average labor cost of $103 per hour, which will be used in this ICR.
For purchased services related to attest engagements and some items of
registration, we have doubled this hourly cost to $206 in order to more
accurately reflect the cost of a certified public accountant (CPA) or
licensed professional engineer's (PE) services.

c.  	Estimating the Agency Burden and Cost

	EPA must generate company and facility registration number(s) for new
registrants and notify them of these numbers, which must appear on
reports. Report formats and instructions/guidance must be prepared by
Agency personnel.  Reports will be processed by contractors and must be
reviewed by Agency personnel.  Reporting parties must be contacted if
there is a problem with their submission. We have developed forms for
RFS2 reporting to include four types, rather than one type, of RIN
unlike the RFS1 templates. We have provided RFS2 reporting templates as
an attachment to this document.

This supporting statement considers all Agency costs associated with
accepting new registrants and new reports associated with RFS2, as
expressed in EPA ICR Number 2333.02. Using the RFS1, and the RFG and
anti-dumping ICR, and other recent fuels-related ICRs as a guide in
developing these initial estimates for RFS, we anticipate that RFS2 may
require the equivalent labor of one full time GS-13 technical employees
for a total of $115,000, and labor costs of $54,875 in the clerical
category and $19,438 in the management category.  Since we are using the
CDX, some costs incurred by the Agency will be tied to the number of
registrants who send us reports.  Specifically, there is an annual
"subscription cost" associated with the use of CDX that is passed on to
the EPA program office and we estimate that registrants due to RFS2 will
cost our office approximately $200,000 per year in 2013, 2014 and 2015.
We anticipate $266,666 in annual contract costs related to registration
and reporting activities.  We anticipate IT development and testing
costs at $ 600,000 divided by three years to yield an annual cost of
$200,000.  Adding the following values results in an annual estimated
Agency burden as follows:

One GS-13 technical employee (full time) = 		$   115,000

One GS-7 clerical worker (full-time) 	 = 	      	       54,875

One GS-15 manager (1/8 time) 	 = 		       19,438

Annual CDX subscription fee = 			     200,000

Annual contract costs = 				     266,666

Testing and development= 				     200,000

TOTAL = 						   $855,979

  As with all items in this supporting statement, we strongly encourage
comment on the estimated Agency burden and on the Agency activities
associated with this proposed information collection.

d.	Estimating the Respondent Universe

	We were able to estimate the number of regulated entities drawing upon
experience regulating the same or similar entities.  	We were able to
estimate the number of regulated entities drawing upon experience
regulating the same or similar entities.

e.	Bottom Line Burden Hours and Costs

	From the tables, we estimate the following totals:

TOTAL NO. OF RESPONDENTS:    	2,092,731

TOTAL NO. OF RESPONSES:		2,702,531

TOTAL BURDEN HOURS:    	    	6,379,263

TOTAL COST TO RESPONDENTS:  	$ 60,459,623

f.	Reason for Change in Burden

	At the onset of the RFS2 program, EMTS for RINs were not a feature of
RFS1.  For the new EMTS system, all parties who owned RINs were required
to re-submit their application, disclose feedstock sources, prepare
quarterly reports on RIN activity and submit annual compliance reports
(obligated party only).  Re-submittal provisions are no longer required
which will cause a decrease in total responses for this ICR.   EMTS
users will not be burdened to submit more reports in this information
collection, unlike the previous.  The total responses for industry
dropped from 4,525,625 to 2,092,731 a difference of 2,432894, now that
the final rule is no longer requiring re-submissions or quarterly
reports for certain party members.  To date, biofuels producers and
importers are required to submit quarterly reports along with their
third party disclosure on feedstock producers to EPA.  All users of the
EMTS system are required to submit quarterly RIN reports.

	The number of respondents or users of the EMTS system has more than
doubled from 1,059,326 to 2,092,731 an increase of 1,639,992, caused by
the additional response burden for mapping foreign and domestic
plantation/forest land owners and foreign biofuels feedstock producers
which was not reflected in the previous ICR reporting period.   With an
increase of respondents, total burden hours have increased by more than
4 million costing the industry $60,459,623 a decreased of $47,882,366.
The reduction in the total cost for this renewal is due to the fact that
the EMTS system’s automation structure helps users to prepare reports
instantly, lessening the amount of time and cost needed to respond, even
with more than a million added users.  This notable factor increased the
industry burden hours but, will lower the total cost of this information
collection request if renewed.

g.	Burden Statement

	The annual public reporting and recordkeeping burden for this
collection of information is estimated to be 2.4 hours per response.
Burden means the total time, effort, or financial resources expended by
persons to generate, maintain, retain, or disclose or provide
information to or for a Federal agency.  This includes the time needed
to review instructions; develop, acquire, install, and utilize
technology and systems for the purposes of collecting, validating, and
verifying information, processing and maintaining information, and
disclosing and providing information; adjust the existing ways to comply
with any previously applicable instructions and requirements; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.  An agency may not
conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB
control number.  The OMB control numbers for EPA's regulations are
listed in 40 CFR part 9 and 48 CFR chapter 15.

	To comment on the Agency's need for this information, the accuracy of
the provided burden estimates, and any suggested methods for minimizing
respondent burden, including the use of automated collection techniques,
EPA has established a public docket for this ICR under Docket ID number
EPA-HQ-OAR-2005-0161, which is available for online viewing at
HYPERLINK "http://www.regulations.gov" www.regulations.gov , or in
person viewing at the Air Docket in the EPA Docket Center in Washington,
DC (EPA/DC).  The docket is located in the EPA West Building, 1301
Constitution Avenue, NW, Room 3334, and is open from 8:30 a.m. to 4:30
p.m., Eastern Standard Time, Monday through Friday, excluding legal
holidays.  The telephone number for the Reading Room is<PHONE_NUMBER>,
and the telephone number for the Air Docket is<PHONE_NUMBER>.

	You may use www.regulations.gov to submit or view public comments,
access the index listing of the contents of the public docket, and to
access those documents in the public docket that are available
electronically.  When in the system, select “search,” then key in
the Docket ID Number EPA-HQ-OAR-2005-0161.  Also, you can send comments
to the Office of Information and Regulatory Affairs, Office of
Management and Budget, 725 17th Street, NW, Washington, D.C. 20503,
Attention: Desk Officer for EPA.  Please include the EPA Docket ID
Number EPA-HQ-OAR-2005-0161 and OMB Control Number 2060-NEW in any
correspondence.

.

 These estimates are derived from "OPM Salary Table 2012-DCB," effective
January 2012.  This table may be found at
http://www.opm.gov/oca/06tables/indexGS.asp.  The extreme of step 10 was
assumed for all categories.  We have assumed a full-time GS-7 clerical
worker, one full-time GS-13 technical worker, and a GS-15 manager
working one-eighth of his/her time managing this project (0.125).  All
values were multiplied by 1.6 (which is a common factor utilized in ICRs
to account for overhead costs). We rounded the resulting dollar value to
the nearest thousand.  This cost is per year.

 PAGE


[Federal Register: June 9, 2010 (Volume 75, Number 110)]
[Notices]
[Page 32798]
[DOCID:fr09jn10-74]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

FDA-2010-N-0254

Preparation for International Cooperation on Cosmetic
Regulations; Public Meeting

AGENCY:  Food and Drug Administration, HHS.

ACTION: Notice of meeting.

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

SUMMARY:  The Food and Drug Administration (FDA) is announcing a public
meeting entitled ``International Cooperation on Cosmetic Regulations
(ICCR)--Preparation for ICCR-4 Meetings in Toronto, Canada'' to provide
information and receive comments on the ICCR as well as the upcoming
meetings in Toronto, Canada. The topics to be discussed are the topics
for discussion at the forthcoming ICCR Steering Committee meeting. The
purpose of the meeting is to solicit public input prior to the next
Steering Committee and expert working group meetings in Toronto, Canada
the week of July 12, 2010.
    Date and Time: The meeting will be held on Wednesday, July 7, 2010,
from 1:30 p.m. to 3:30 p.m.
    Location: The meeting will be held in the Washington Theater at the
Hilton Washington DC/Rockville Hotel & Executive Meeting Center, 1750
Rockville Pike, Rockville, MD 20852.
    Contact Person: All participants must register with Jennifer
Haggerty, Office of the Commissioner, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 31, rm. 3567, Silver Spring, MD 20903,
301-796-4600. Register by emailing<EMAIL_ADDRESS>    Registration and Requests for Oral Presentations: Send registration
information (including name, title, firm name, address, telephone, and
fax number), written material and requests to make oral presentation,
to the contact person by July 2, 2010.
    If you need special accommodations due to a disability, please
contact Jennifer Haggerty (see Contact Person) at least 7 days in
advance.
    Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at http://www.regulations.gov. It may
be viewed at the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD. A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to Division of Freedom of Information (HFI-35), Office
of Management Programs, Food and Drug Administration, 5600 Fishers
Lane, rm. 6-30, Rockville, MD 20857.

SUPPLEMENTARY INFORMATION: The purpose of the multilateral framework on
the ICCR is to pave the way for the removal of regulatory obstacles to
international trade while maintaining global consumer protection.
    ICCR is a voluntary international group of cosmetics regulatory
authorities from the United States, Japan, the European Union, and
Canada. These regulatory authority members will enter into constructive
dialogue with their relevant cosmetics' industry trade associations.
Currently, the ICCR members are Health Canada; the European Directorate
General for Enterprise and Industry; the Ministry of Health, Labor and
Welfare of Japan; and the U.S. Food and Drug Administration. All
decisions made by the consensus will be compatible with the laws,
policies, rules, regulations, and directives of the respective
administrations and governments. Members will implement and/or promote
actions or documents within their own jurisdictions and seek
convergence of regulatory policies and practices. Successful
implementation will require input from stakeholders.
    Interested persons may present data, information, or views orally
or in writing, on issues pending at the public meeting. Time allotted
for oral presentations may be limited to 10 minutes. Those desiring to
make oral presentations should notify the contact person by July 2,
2010, and submit a brief statement of the general nature of the
evidence or arguments they wish to present, the names and addresses,
telephone number, fax, and e-mail of proposed participants, and an
indication of the approximate time requested to make their
presentation.
    The agenda for the public meeting will be made available on the
Internet at: http://www.fda.gov/Cosmetics/InternationalActivities/
ConferencesMeetingsWorkshops.

    Dated: June 4, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-13821 Filed 6-8-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register Volume 84, Number 60 (Thursday, March 28, 2019)]
[Notices]
[Pages 11801-11802]
[FR Doc No: 2019-05944]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-1131]

Annual Public Meeting; Reagan-Udall Foundation for the Food and
Drug Administration

AGENCY: Reagan-Udall Foundation, FDA, HHS.

ACTION: Notice of annual meeting.

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

SUMMARY: The Reagan-Udall Foundation (the Foundation) for the Food and
Drug Administration (FDA), which was created by Title VI of the Food
and Drug Administration Amendments Act of 2007, is announcing its
annual public meeting. The Foundation will discuss its activities and
how they support FDA.

DATES: The public meeting will be held on May 2, 2019, from 10 a.m.
until 12 noon. Registration to attend the meeting must be received by
April 30, 2019, at 5 p.m. Eastern Time. Requests for oral presentation
must be received before April 30, 2019, at 5 p.m. Eastern Time. See the
SUPPLEMENTARY INFORMATION section for registration date and
information. The public is also invited to submit written comments by
sending them via email to Kelly Catterton (see FOR FURTHER INFORMATION
CONTACT) before April 30, 2019, at 5 p.m. Eastern Time.

ADDRESSES: The public meeting will be held at the PEW Charitable
Trusts, 901 E St. NW, Washington, DC 20004.

FOR FURTHER INFORMATION CONTACT: Kelly Catterton, Executive Assistant
to the Executive Director, Reagan-Udall Foundation for FDA, 202-849-
2255<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The Reagan-Udall Foundation for the FDA is an independent 501(c)(3)
not-for-profit, organization created by Congress to advance the mission
of FDA to modernize medical, veterinary, food, food ingredient, and
cosmetic product development; accelerate innovation, and enhance
product safety. With the ultimate goal of improving public health, the
Foundation provides a unique opportunity for different sectors (FDA,
patient groups, academia, other government entities, and industry) to
work together in a transparent way to create exciting new research and
engagement projects to advance regulatory science.
    The Foundation acts as a neutral third party to establish novel,
scientific collaborations. Much like any other independently developed
information, FDA evaluates the scientific information from these
collaborations to determine how the Foundation projects can help the
Agency to fulfill its mission.
    Foundation projects currently include: Innovation in Medical
Evidence Development and Surveillance, a public-private partnership
that allows researchers to study drug safety concerns of interest to
public health; an Expanded Access Navigator that offers instructional
material and resources for physicians, patients, and their caregivers
on how to access investigational drugs outside of clinical trials; and
a new joint Foundation and FDA regulatory science fellowship program.

II. Topics for Discussion at the Public Meeting

    FDA Center Directors will hold a panel discussion on pressing FDA
initiatives suitable for Public-Private Partnerships. Panelists will
include Drs. Janet Woodcock, Peter Marks, and Jeffrey Shuren. The panel
moderator will be Michael McCaughan, Co-Founder of Prevision Policy.
Find the meeting page at http://reaganudall.org/2019-annual-public-meeting-0.

III. Participating in the Public Meeting

    Registration: To register for the public meeting, please visit the
following website to register: https://reaganudall.salsalabs.org/2019AnnualMeeting/index.html. Persons interested in attending this
public meeting must register online by April 30, 2019, at 5 p.m.
Eastern Time.
    If you need special accommodations due to a disability, please
contact Kelly Catterton (see FOR FURTHER INFORMATION CONTACT) no later
than April 30, 2019, at 5 p.m. Eastern Time.
    Requests for Oral Presentations: Interested persons may present
comments at the public meeting. Comments will be scheduled to begin
approximately at 11:45 a.m. Time allotted for comments is limited to 3
minutes per speaker. Those desiring to make oral comments should notify
Kelly Catterton (see FOR FURTHER INFORMATION CONTACT) by April 30,
2019, at 5 p.m. Eastern Time. Please include a brief statement of the
general nature of the comments you wish to present along with your
name, address, telephone number, and email address. The contact person
will notify individuals regarding their request to speak by May 1,
2019.

    Dated: March 22, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-05944 Filed 3-27-19; 8:45 am]
 BILLING CODE 4164-01-P


CWA purposes. Upon further consideration of comments received on its
proposed rule, EPA decided not to finalize this provision. Pursuant to
40 CFR 131.21(c), EPA's federally promulgated WQS are and will be
applicable for purposes of the CWA until EPA withdraws those federally
promulgated WQS. EPA would undertake such a rulemaking to withdraw the
federal criteria if and when Washington adopts and EPA approves
corresponding criteria that meet the requirements of section 303(c) of
the CWA and EPA's implementing regulations at 40 CFR part 131.

F. Alternative Regulatory Approaches and Implementation Mechanisms

    Washington has considerable discretion to implement these revised
and new federal human health criteria through various water quality
control programs including the NPDES program, which limits discharges
to waters except in compliance with a NPDES permit. EPA's regulations
at 40 CFR 131.14 authorize states and authorized tribes to adopt WQS
variances to provide time to achieve the applicable WQS. 40 CFR part
131 defines WQS variances at 131.3(o) as time-limited designated uses
and supporting criteria for a specific pollutant(s) or water quality
parameter(s) that reflect the highest attainable conditions during the
term of the WQS variances. WQS variances adopted in accordance with 40
CFR part 131 allow states and authorized tribes to address water
quality challenges in a transparent and predictable way. Variances help
states and authorized tribes focus on making incremental progress in
improving water quality, rather than pursuing a downgrade of the
underlying water quality goals through a designated use change, when
the designated use is not attainable throughout the term of the
variance due to one of the factors listed in 40 CFR 131.14. EPA's
regulations at 40 CFR 122.47 provide the requirements when states and
authorized tribes wish to include permit compliance schedules in their
NPDES permits if dischargers need additional time to meet their water
quality-based limits based on the applicable WQS. EPA's updated
regulations at 40 CFR 131.15 require any state or authorized tribe
wishing to use permit compliance schedules to also include provisions
authorizing the use of permit compliance schedules after appropriate
public involvement to ensure that a decision to allow permit compliance
schedules derives from and complies with the applicable WQS. (80 FR
51022, August 21, 2015).
    40 CFR 131.10 specifies how states and authorized tribes establish,
modify or remove designated uses for their waters. 40 CFR 131.11
specifies the requirements for establishing criteria to protect
designated uses, including criteria modified to reflect site-specific
conditions. In the context of this rulemaking, a site-specific
criterion (SSC) is an alternative value to the federal human health
criteria that could be applied on a watershed, area-wide, or waterbody-
specific basis that meets the regulatory test of protecting the
designated use, being scientifically defensible, and ensuring the
protection and maintenance of downstream WQS. A SSC may be more or less
stringent than the otherwise applicable federal criterion. A SSC may be
appropriate when further scientific data and analyses can bring added
precision to express the concentration of a particular pollutant that
protects the human health-related designated use in a particular
waterbody.
    A few commenters supported EPA's acknowledgement of the
flexibilities that Washington has available when implementing the final
criteria in this rule, while others commented that these tools allow
Washington to delay or avoid implementing the criteria. EPA did not
propose to change, nor does this final rule change, any of the
flexibilities already afforded to Washington by EPA's regulations to
modify or remove designated uses, adopt variances, issue compliance
schedules, or establish site-specific criteria. These implementation
tools are important for making incremental progress and allowing the
time for adaptive management when designated uses and associated
criteria are difficult to attain. Washington may continue to use any of
these regulatory flexibilities when implementing the final federal
human health criteria.
a. Designating Uses
    EPA's final human health criteria apply to waters that Washington
has designated for the following: Fresh waters--Harvesting (fish
harvesting), Domestic Water (domestic water supply), and Recreational
Uses; Marine waters--Shellfish Harvesting (shellfish--clam, oyster, and
mussel--harvesting), Harvesting (salmonid and other fish harvesting,
and crustacean and other shellfish--crabs, shrimp, scallops, etc.--
harvesting), and Recreational Uses (see WAC 173-201A-600 and WAC 173-
201A-610). If Washington removes the Domestic Water use but retains any
of the other above designated uses for any particular waterbody
affected by this final rule, and EPA finds that removal to be
consistent with CWA section 303(c) and EPA's implementing regulations
at 40 CFR part 131, then the federal organism-only criteria will apply
in place of the federal water-plus-organism criteria. If Washington
removes designated uses such that none of the above uses apply to any
particular waterbody affected by this final rule and adopts the highest
attainable use, as defined by 40 CFR 131.3(m), consistent with 40 CFR
131.10(g), and EPA finds that removal to be consistent with CWA section
303(c) and EPA's implementing regulations at 40 CFR part 131, then the
federal human health criteria will no longer apply to that waterbody.
Instead, any criteria associated with the newly designated highest
attainable use would apply to that waterbody.
b. Variances and Compliance Schedules
    EPA's final human health criteria apply to use designations that
Washington has already established. Concurrent with this final rule,
EPA approved revisions to Washington's variance and compliance schedule
authorizing provisions. Washington may use its EPA-approved variance
procedures (see WAC 173-201A-420) to establish time-limited designated
uses and criteria to apply for the purposes specified in 40 CFR 131.14
as it pertains

to federal criteria when adopting such variances. Washington has
sufficient authority to use variances when implementing the human
health criteria as long as such variances are adopted consistent with
40 CFR 131.14, and submitted to EPA for review under CWA section
303(c). Similarly, Washington may use its EPA-approved regulation
authorizing the use of permit compliance schedules (see WAC 173-201A-
510(4)), consistent with 40 CFR 131.15, to grant compliance schedules,
as appropriate, for WQBELs based on the federal criteria. These state
regulations are not affected by this final rule.
c. Site-Specific Criteria
    As discussed in section III.E, if Washington adopts and EPA
approves site-specific criteria that fully meet the requirements of
section 303(c) of the CWA and EPA's implementing regulations at 40 CFR
part 131, EPA will undertake a rulemaking to withdraw the corresponding
federal criteria.

IV. Economic Analysis

    Under the CWA, water quality criteria are set on the basis of the
latest scientific knowledge. EPA is not required under the CWA nor
obligated under Executive Orders 12866 and 13563 to conduct an economic
analysis of the criteria. Costs cannot be considered in establishing
water quality criteria as part of WQS. Nonetheless, EPA conducted a
cost analysis for the criteria in this final rule for the purpose of
transparency and presents this information reflecting the potential
economic effects of the rule.
    These WQS may serve as a basis for development of NPDES permit
limits. Washington has NPDES permitting authority, and retains
considerable discretion in implementing standards. EPA evaluated the
potential costs to NPDES dischargers associated with state
implementation of EPA's final criteria. This analysis is documented in
Final Economic Analysis for the Revision of Certain Federal Water
Quality Criteria Applicable to Washington, which can be found in the
record for this rulemaking.
    Any NPDES-permitted facility that discharges pollutants for which
the revised human health criteria are more stringent than the
applicable aquatic life criteria (or for which human health criteria
are the only applicable criteria) could potentially incur compliance
costs. The types of affected facilities could include industrial
facilities and POTWs discharging wastewater to surface waters (i.e.,
point sources). EPA did not attribute compliance with water quality-
based effluent limitations (WQBELs) reflective of existing federal
human health criteria applicable to Washington (hereafter referred to
as ``baseline criteria'') to the final rule. Once in compliance with
WQBELs reflective of baseline criteria, EPA expects that dischargers
will continue to use the same types of controls to come into compliance
with the revised criteria; EPA did not fully evaluate the potential for
costs to nonpoint sources,\69\ such as agricultural runoff, that could
be incurred under a TMDL for this analysis, but did analyze the
administrative costs to the state of preparing TMDLs for potentially
incrementally impaired waters. Actual costs of implementation of TMDLs
is beyond the scope of this analysis.
---------------------------------------------------------------------------

    \69\ The CWA does not regulate nonpoint sources. However, EPA
recognizes that the state may require controls for nonpoint sources
as part of potential incremental TMDLs. It is difficult to model and
evaluate the potential cost impacts of this final rule to nonpoint
sources because they are intermittent, variable, and occur under
hydrologic or climatic conditions associated with precipitation
events. Also, data on instream and discharge levels of the
pollutants of concern after dischargers have implemented controls to
meet current WQS, total maximum daily loads (TMDLs) for impaired
waters, or other water quality improvement plans, are not available.
Therefore, trying to determine which sources would not achieve WQS
based on the revised human health criteria after complying with
existing regulations and policies may not be possible. In addition,
legacy contamination (e.g., in sediment) may be a source of ongoing
loading. Atmospheric deposition may also contribute loadings of the
pollutants of concern (e.g., mercury). EPA did not estimate sediment
remediation costs, or air pollution controls costs, for this
analysis because EPA did not have data on the contribution of these
sources, and because control costs for deposition may be covered by
Clean Air Act rules.
---------------------------------------------------------------------------

A. Identifying Affected Entities

    EPA identified 406 point source facilities that could ultimately be
affected by this final rule. Of these potentially affected facilities,
73 are major dischargers and 333 are minor dischargers. EPA did not
include general permit facilities in its analysis because data for such
facilities are limited, and flows are usually negligible. Of the
potentially affected facilities, EPA evaluated a sample of 17 major
facilities. Minor facilities are unlikely to incur costs as a result of
implementation of the rule, because minor facilities are typically
those that do not discharge toxics in toxic amounts and discharge less
than 1 million gallons per day (mgd). Although lower human health
criteria could potentially change this categorization, EPA did not have
effluent data on toxic pollutants to evaluate minor facilities for this
analysis. Table 2 summarizes these potentially affected facilities by
type and category.

                                    Table 2--Potentially Affected Facilities
----------------------------------------------------------------------------------------------------------------
                            Category                                   Minor           Major            All
----------------------------------------------------------------------------------------------------------------
Municipal.......................................................             184              48             232
Industrial......................................................             149              25             174
                                                                 -----------------------------------------------
    Total.......................................................             333              73             406
----------------------------------------------------------------------------------------------------------------

B. Method for Estimating Costs

    EPA evaluated the two major municipal facilities with design flows
greater than 100 mgd and a large industrial refinery, to attempt to
capture the facilities with the potential for the largest costs. For
the remaining major facilities, EPA evaluated a random sample of
facilities to represent discharger type and category. For all sample
facilities, EPA evaluated existing baseline permit conditions,
reasonable potential to exceed human health criteria based on the final
rule, and potential to exceed projected effluent limitations based on
the last three years of effluent monitoring data (if available). In
instances of exceedances of projected effluent limitations under the
final criteria, EPA determined the likely compliance scenarios and
costs. Only compliance actions and costs that would be needed above the
baseline level of controls are attributable to the final rule.
    EPA assumed that dischargers will pursue the least cost means of
compliance with WQBELs. Incremental compliance actions attributable to
the final rule may include pollution prevention, end-of-pipe treatment,
and alternative compliance mechanisms (e.g., variances). EPA annualized
one-

time costs (capital costs and variance costs) over 20 years using a 3
percent discount rate to obtain total annual costs per facility. For
the random sample, EPA extrapolated the annualized costs based on the
sampling weight for each sample facility. To obtain an estimate of
total costs to point sources, EPA added the results for the certainty
sample to the extrapolated random sample costs.

C. Results

    Based on the results for 17 sample facilities across 8 industrial
and municipal categories,\70\ EPA estimated a total annual compliance
cost of approximately $126,000 to $150,000 for all major dischargers in
the state (using a 3 percent discount rate). Only five facilities are
estimated to incur pollution prevention program costs, while two
facilities are expected to also incur costs of obtaining a variance.
Most of the facilities would not bear any cost. The low end of the
range reflects the assumption that the compliance actions (e.g.,
pollution prevention) will result in compliance with projected effluent
limits, whereas the high scenario reflects projected effluent limits
not being met, and thus includes the estimated administrative cost of
also obtaining a variance. All compliance costs are for industrial
facilities, and are attributable to the human health criterion for
methylmercury.
---------------------------------------------------------------------------

    \70\ Seven industrial categories (mining, food and kindred
products, paper and allied products, chemicals and allied products,
petroleum refining and related industries, primary metal industries,
and transportation and public utilities (except POTWs)) and
municipal POTWs.
---------------------------------------------------------------------------

    If the revised criteria result in an incremental increase in
impaired waters, resulting in the need for TMDL development, there
could also be some costs to nonpoint sources of pollution. Using
available ambient monitoring data, EPA compared pollutant
concentrations to the baseline and final criteria, identifying
waterbodies that may be incrementally impaired (i.e., impaired under
the final criteria but not under the baseline). For the parameters and
stations for which EPA had sufficient monitoring data available to
evaluate, there were 50 impairments under the baseline criteria and 124
under the final criteria, for a total of 74 potential incremental
impairments (or a 148 percent increase relative to the baseline;
including for methylmercury, PCBs, and DDT). This increase indicates
the potential for nonpoint sources to bear some compliance costs,
although data are not available to estimate the magnitude of these
costs. The control of nonpoint sources such as in the context of a TMDL
could result in different requirements, and thus different costs, for
point sources.
    If the net increase in potential impairments is any indication of
the potential increase in the number of TMDLs, then the total
administrative costs for TMDL development could be in the range of $2.7
million to $3.0 million based on national average single-cause single-
waterbody TMDL development costs from U.S. EPA (2001; updated to 2014
dollars). However, these costs may be reduced if Ecology develops
multi-cause or multi-waterbody TMDLs. If these costs are spread over 8
to 15 years, at a discount rate of 3 percent, the annualized costs of
developing TMDLs are $229,000 to $422,000.
    Combining the potential facility compliance costs and TMDL
administrative costs results in total annual costs of $355,000 to
$572,000, at a 3 percent discount rate.

V. Statutory and Executive Order Reviews

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

    It has been determined that this final rule is not a ``significant
regulatory action'' under the terms of Executive Order 12866 (58 FR
51735, October 4, 1993) and is, therefore, not subject to review under
Executive Orders 12866 and 13563 (76 FR 3821, January 21, 2011). The
final rule does not establish any requirements directly applicable to
regulated entities or other sources of toxic pollutants. However, these
WQS may serve as a basis for development of NPDES permit limits.
Washington has NPDES permitting authority, and retains considerable
discretion in implementing standards. In the spirit of Executive Order
12866, EPA evaluated the potential costs to NPDES dischargers
associated with state implementation of EPA's final criteria. This
analysis, Final Economic Analysis for the Revision of Certain Federal
Water Quality Criteria Applicable to Washington, is summarized in
section IV of the preamble and is available in the docket.

B. Paperwork Reduction Act

    This action does not impose any direct new information collection
burden under the provisions of the Paperwork Reduction Act, 44 U.S.C.
3501 et seq. Actions to implement these WQS could entail additional
paperwork burden. Burden is defined at 5 CFR 1320.3(b). This action
does not include any information collection, reporting, or record-
keeping requirements.

C. Regulatory Flexibility Act

    I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA. This
action will not impose any requirements on small entities. EPA has the
authority to promulgate WQS in any case where the Administrator
determines that a new or revised standard is necessary to meet the
requirements of the CWA. EPA-promulgated standards are implemented
through various water quality control programs including the NPDES
program, which limits discharges to navigable waters except in
compliance with an NPDES permit. The CWA requires that all NPDES
permits include any limits on discharges that are necessary to meet
applicable WQS. Thus, under the CWA, EPA's promulgation of WQS
establishes standards that the state implements through the NPDES
permit process. The state has discretion in developing discharge
limits, as needed to meet the standards. As a result of this action,
the State of Washington will need to ensure that permits it issues
include any limitations on discharges necessary to comply with the
standards established in the final rule. In doing so, the state will
have a number of choices associated with permit writing. While
Washington's implementation of the rule may ultimately result in new or
revised permit conditions for some dischargers, including small
entities, EPA's action, by itself, does not impose any of these
requirements on small entities; that is, these requirements are not
self-implementing.

D. Unfunded Mandates Reform Act

    This action contains no federal mandates under the provisions of
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C.
1531-1538 for state, local, or tribal governments or the private
sector. As these water quality criteria are not self-implementing,
EPA's action imposes no enforceable duty on any state, local or tribal
governments or the private sector. Therefore, this action is not
subject to the requirements of sections 202 or 205 of UMRA.
    This action is also not subject to the requirements of section 203
of UMRA because it contains no regulatory requirements that could
significantly or uniquely affect small governments.

E. Executive Order 13132 (Federalism)

    This action does not have federalism implications. It will 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. This rule does
not alter Washington's considerable discretion in implementing these
WQS, nor will it preclude Washington from adopting WQS in the future
that EPA concludes meet the requirements of the CWA, which will
eliminate the need for federal standards. Thus, Executive Order 13132
does not apply to this action.

F. Executive Order 13175 (Consultation and Coordination With Indian
Tribal Governments)

    This action has tribal implications. However, it will neither
impose substantial direct compliance costs on federally recognized
tribal governments, nor preempt tribal law. In the State of Washington,
there are 29 federally recognized Indian tribes. To date, nine of these
Indian tribes have been approved for TAS for CWA sections 303 and
401.\71\ Of these nine tribes, seven have EPA-approved WQS in their
respective jurisdictions.\72\ This rule could affect federally
recognized Indian tribes in Washington because the numeric criteria for
Washington will apply to waters adjacent to (or upstream or downstream
of) the tribal waters, where many of those tribes have treaty rights to
take fish for their subsistence. Additionally, there are ten federally
recognized Indian tribes in the Columbia River Basin located in the
states of Oregon and Idaho that this rule could impact because their
waters could affect or be affected by the water quality of Washington's
downstream or upstream waters.
---------------------------------------------------------------------------

    \71\ http://water.epa.gov/scitech/swguidance/standards/wqslibrary/approvtable.cfm.
    \72\ http://yosemite.epa.gov/r10/water.nsf/34090d07b77d50bd88256b79006529e8/dd2a4df00fd7ae1a88256e0500680e86!OpenDocument. Note that this number
does not include the Confederated Tribes of the Colville
Reservation, which has federally promulgated WQS from 1989. EPA is
currently reviewing the Colville Tribe's application for TAS.
---------------------------------------------------------------------------

    EPA consulted with federally recognized tribal officials under
EPA's Policy on Consultation and Coordination with Indian Tribes early
in the process of developing this rule to permit them to have
meaningful and timely input into its development. In February and March
2015, EPA held tribes-only technical staff and leadership consultation
sessions to hear their views and answer questions of all interested
tribes on the proposed rule. Representatives from approximately 23
tribes and four tribal consortia participated in two leadership
meetings held in March 2015. EPA and tribes have also met regularly
since November 2012 to discuss Washington's human health criteria at
both the tribal leadership level and technical staff level. The tribes
have repeatedly asked EPA to promulgate federal human health criteria
for Washington if the state did not do so in a timely and protective
manner. At these meetings, the tribes consistently emphasized that the
human health criteria should be derived using at least a minimum FCR
value of 175 g/day, a cancer risk level of 10-6, and the
latest scientific information from EPA's 304(a) recommended criteria.
EPA considered the input received during consultation with tribes when
developing this final rule (see section III for additional discussion
of how EPA considered tribal input).
    In subsequent coordination with tribes, EPA received a letter on
August 5, 2016, from the Northwest Indian Fisheries Commission
disagreeing with EPA's potential adjustments to the RSC from the
proposed rule issued on September 14, 2015 to the final rule as a
result of public comments. The tribes expressed concern that less
stringent human health criteria as a result of the RSC adjustment would
result in lower protection of designated uses and limit the ability to
exercise tribal treaty rights, especially in light of a FCR that
underestimates tribal consumption. EPA considered this information
carefully before finalizing this rule, but for the reasons stated
above, decided to adjust the RSC to account for inclusion of some
marine fish in the FCR. This results in protective criteria that
account for other routes of exposure in addition to drinking water and
fish and shellfish from inland and nearshore waters and is consistent
with EPA's guidance.

G. Executive Order 13045 (Protection of Children From Environmental
Health and Safety Risks)

    This rule is not subject to Executive Order 13045, because it is
not economically significant as defined in Executive Order 12866, and
because the environmental health or safety risks addressed by this
action do not present a disproportionate risk to children.

H. Executive Order 13211 (Actions That Significantly Affect Energy
Supply, Distribution, or Use)

    This action is not a ``significant energy action'' because it is
not likely to have a significant adverse effect on the supply,
distribution, or use of energy.

I. National Technology Transfer and Advancement Act of 1995

    This final rulemaking does not involve technical standards.

J. Executive Order 12898 (Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations)

    This action will not have disproportionately high and adverse human
health or environmental effects on minority or low-income populations.
Conversely, this action identifies and ameliorates disproportionately
high and adverse human health effects on minority populations and low-
income populations in Washington. EPA developed the human health
criteria included in this final rule specifically to protect
Washington's designated uses, using the most current science, including
local and regional information on fish consumption. Applying these
criteria to waters in the State of Washington will afford a greater
level of protection to both human health and the environment.

K. Congressional Review Act (CRA)

    This action is subject to the CRA, and 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 131

    Environmental protection, Indians-lands, Intergovernmental
relations, Reporting and recordkeeping requirements, Water pollution
control.

    Dated: November 15, 2016.
Gina McCarthy,
Administrator.

    For the reasons set forth in the preamble, EPA amends 40 CFR part
131 as follows:

PART 131--WATER QUALITY STANDARDS

0
1. The authority citation for part 131 continues to read as follows:

    Authority:  33 U.S.C. 1251 et seq.

Subpart D--Federally Promulgated Water Quality Standards

Sec.  131.36   [Amended]

0
2. In Sec.  131.36, remove paragraph (d)(14).

0
3. Add Sec.  131.45 to read as follows:

Sec.  131.45   Revision of certain Federal water quality criteria
applicable to Washington.

    (a) Scope. This section promulgates human health criteria for
priority toxic

pollutants in surface waters in Washington.
    (b) Criteria for priority toxic pollutants in Washington. The
applicable human health criteria are shown in Table 1.

                                                      Table 1--Human Health Criteria for Washington
--------------------------------------------------------------------------------------------------------------------------------------------------------
                      A                                                              B                                                     C
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                               Cancer slope     Relative      Reference                           Bio-          Water &
                                                factor, CSF      source       dose, RfD   Bio-accumulation    concentration    organisms  Organisms only
             Chemical                CAS No.     (per mg/    contribution,      (mg/        factor (L/kg      factor  (L/kg   ([micro]g/    ([micro]g/L)
                                               kg[middot]d)     RSC (-)     kg[middot]d)       tissue)           tissue)          L)
                                    .........          (B1)          (B2)           (B3)              (B4)              (B5)        (C1)            (C2)
--------------------------------------------------------------------------------------------------------------------------------------------------------
1. 1,1,1-Trichloroethane..........      71556  ............          0.50              2                10  ................      20,000          50,000
2. 1,1,2,2-Tetrachloroethane......      79345           0.2             -   ............               8.4  ................         0.1             0.3
3. 1,1,2-Trichloroethane..........      79005         0.057             -   ............               8.9  ................        0.35            0.90
4. 1,1-Dichloroethylene...........      75354  ............          0.50           0.05               2.6  ................         700           4,000
5. 1,2,4-Trichlorobenzene.........     120821         0.029             -   ............               430  ................       0.036           0.037
6. 1,2-Dichlorobenzene............      95501  ............          0.50            0.3                82  ................         700             800
7. 1,2-Dichloroethane.............     107062        0.0033             -   ............               1.9  ................         8.9              73
8. 1,2-Dichloropropane............      78875  ............             -   ............  ................  ................  ..........  ..............
9. 1,2-Diphenylhydrazine..........     122667           0.8             -   ............                27  ................        0.01            0.02
10. 1,2-Trans-Dichloroethylene....     156605  ............          0.50           0.02               4.7  ................         200           1,000
11. 1,3-Dichlorobenzene...........     541731  ............          0.50          0.002               190  ................           2               2
12. 1,3-Dichloropropene...........     542756         0.122             -   ............               3.0  ................        0.22             1.2
13. 1,4-Dichlorobenzene...........     106467  ............          0.50           0.07                84  ................         200             200
14. 2,3,7,8-TCDD (Dioxin) **......    1746016       156,000             -   ............  ................             5,000     1.3E-08         1.4E-08
15. 2,4,6-Trichlorophenol.........      88062  ............             -   ............  ................  ................  ..........  ..............
16. 2,4-Dichlorophenol............     120832  ............          0.50          0.003                48  ................          10              10
17. 2,4-Dimethylphenol............     105679  ............             -   ............  ................  ................  ..........  ..............
18. 2,4-Dinitrophenol.............      51285  ............          0.50          0.002               4.4  ................          30             100
19. 2,4-Dinitrotoluene............     121142  ............             -   ............  ................  ................  ..........  ..............
20. 2-Chloronaphthalene...........      91587  ............          0.80           0.08               240  ................         100             100
21. 2-Chlorophenol................      95578  ............             -   ............  ................  ................  ..........  ..............
22. 2-Methyl-4,6-Dinitrophenol....     534521  ............          0.50         0.0003                10  ................           3               7
23. 3,3'-Dichlorobenzidine........      91941  ............             -   ............  ................  ................  ..........  ..............
24. 3-Methyl-4-Chlorophenol.......      59507  ............             -   ............  ................  ................  ..........  ..............
25. 4,4'-DDD......................      72548          0.24             -   ............           240,000  ................     7.9E-06         7.9E-06
26. 4,4'-DDE......................      72559         0.167             -   ............         3,100,000  ................     8.8E-07         8.8E-07
27. 4,4'-DDT......................      50293          0.34             -   ............         1,100,000  ................     1.2E-06         1.2E-06
28. Acenaphthene..................      83329  ............          0.50           0.06               510  ................          30              30
29. Acrolein......................     107028  ............             -   ............  ................  ................  ..........  ..............
30. Acrylonitrile.................     107131  ............             -   ............  ................  ................  ..........  ..............
31. Aldrin........................     309002            17             -   ............           650,000  ................     4.1E-08         4.1E-08
32. alpha-BHC.....................     319846           6.3             -   ............             1,500  ................     4.8E-05         4.8E-05
33. alpha-Endosulfan..............     959988  ............          0.50          0.006               200  ................           6               7
34. Anthracene....................     120127  ............          0.50            0.3               610  ................         100             100
35. Antimony......................    7440360  ............          0.50         0.0004  ................                 1           6              90
36. Arsenic **....................    7440382          1.75             -   ............  ................                44   \a\ 0.018        \a\ 0.14
37. Asbestos......................    1332214  ............             -   ............  ................  ................  ..........  ..............
38. Benzene.......................      71432  ............             -   ............  ................  ................  ..........  ..............
39. Benzidine.....................      92875  ............             -   ............  ................  ................  ..........  ..............
40. Benzo(a) Anthracene...........      56553          0.73             -   ............             3,900  ................     0.00016         0.00016
41. Benzo(a) Pyrene...............      50328           7.3             -   ............             3,900  ................     1.6E-05         1.6E-05
42. Benzo(b) Fluoranthene.........     205992          0.73             -   ............             3,900  ................     0.00016         0.00016
43. Benzo(k) Fluoranthene.........     207089         0.073             -   ............             3,900  ................      0.0016          0.0016
44. beta-BHC......................     319857           1.8             -   ............               180  ................      0.0013          0.0014
45. beta-Endosulfan...............   33213659  ............             -   ............  ................  ................  ..........  ..............
46. Bis(2-Chloroethyl) Ether......     111444  ............             -   ............  ................  ................  ..........  ..............
47. Bis(2-Chloro-1-Methylethyl)        108601  ............          0.50           0.04                10  ................         400             900
 Ether *..........................
48. Bis(2-Ethylhexyl) Phthalate...     117817         0.014             -   ............               710  ................       0.045           0.046
49. Bromoform.....................      75252        0.0045             -   ............               8.5  ................         4.6              12
50. Butylbenzyl Phthalate.........      85687        0.0019             -   ............            19,000  ................       0.013           0.013
51. Carbon Tetrachloride..........      56235  ............             -   ............  ................  ................  ..........  ..............
52. Chlordane.....................      57749          0.35             -   ............            60,000  ................     2.2E-05         2.2E-05
53. Chlorobenzene.................     108907  ............          0.50           0.02                22  ................         100             200
54. Chlorodibromomethane..........     124481          0.04             -   ............               5.3  ................        0.60             2.2
55. Chloroform....................      67663  ............          0.50           0.01               3.8  ................         100             600
56. Chrysene......................     218019        0.0073             -   ............             3,900  ................       0.016           0.016
57. Copper........................    7440508  ............             -   ............  ................  ................  ..........  ..............
58. Cyanide.......................      57125  ............          0.50         0.0006  ................                 1           9             100
59. Dibenzo(a,h) Anthracene.......      53703           7.3             -   ............             3,900  ................     1.6E-05         1.6E-05
60. Dichlorobromomethane..........      75274         0.034             -   ............               4.8  ................        0.73             2.8
61. Dieldrin......................      60571            16             -   ............           410,000  ................     7.0E-08         7.0E-08
62. Diethyl Phthalate.............      84662  ............          0.50            0.8               920  ................         200             200
63. Dimethyl Phthalate............     131113  ............          0.50             10             4,000  ................         600             600
64. Di-n-Butyl Phthalate..........      84742  ............          0.50            0.1             2,900  ................           8               8
65. Endosulfan Sulfate............    1031078  ............          0.50          0.006               140  ................           9  ..............
66. Endrin........................      72208  ............          0.80         0.0003            46,000  ................       0.002           0.002
67. Endrin Aldehyde...............    7421934  ............             -   ............  ................  ................  ..........  ..............
68. Ethylbenzene..................     100414  ............          0.50          0.022               160  ................          29              31
69. Fluoranthene..................     206440  ............          0.50           0.04             1,500  ................           6               6
70. Fluorene......................      86737  ............          0.50           0.04               710  ................          10              10
71. gamma-BHC; Lindane............      58899  ............          0.50         0.0047             2,500  ................        0.43            0.43

72. Heptachlor....................      76448           4.1             -   ............           330,000  ................     3.4E-07         3.4E-07
73. Heptachlor Epoxide............    1024573           5.5             -   ............            35,000  ................     2.4E-06         2.4E-06
74. Hexachlorobenzene.............     118741          1.02             -   ............            90,000  ................     5.0E-06         5.0E-06
75. Hexachlorobutadiene...........      87683          0.04             -   ............             1,100  ................        0.01            0.01
76. Hexachlorocyclopentadiene.....      77474  ............          0.50          0.006             1,300  ................           1               1
77. Hexachloroethane..............      67721          0.04             -   ............               600  ................        0.02            0.02
78. Indeno(1,2,3-cd) Pyrene.......     193395          0.73             -   ............             3,900  ................     0.00016         0.00016
79. Isophorone....................      78591  ............             -   ............  ................  ................  ..........  ..............
80. Methyl Bromide................      74839  ............          0.50           0.02               1.4  ................         300  ..............
81. Methylene Chloride............      75092         0.002             -   ............               1.6  ................          10             100
82. Methylmercury.................   22967926  ............       2.7E-05         0.0001  ................  ................  ..........   \b\ 0.03 (mg/
                                                                                kg)
83. Nickel........................    7440020  ............          0.50           0.02  ................                47          80             100
84. Nitrobenzene..................      98953  ............          0.50          0.002               3.1  ................          30             100
85. N-Nitrosodimethylamine........      62759  ............             -   ............  ................  ................  ..........  ..............
86. N-Nitrosodi-n-Propylamine.....     621647  ............             -   ............  ................  ................  ..........  ..............
87. N-Nitrosodiphenylamine........      86306  ............             -   ............  ................  ................  ..........  ..............
88. Pentachlorophenol (PCP).......      87865           0.4             -   ............               520  ................       0.002           0.002
89. Phenol........................     108952  ............          0.50            0.6               1.9  ................       9,000          70,000
90. Polychlorinated Biphenyls       .........             2             -   ............  ................            31,200   \c\ 7E-06       \c\ 7E-06
 (PCBs)...........................
91. Pyrene........................     129000  ............          0.50           0.03               860  ................           8               8
92. Selenium......................    7782492  ............          0.50          0.005  ................               4.8          60             200
93. Tetrachloroethylene...........     127184        0.0021             -   ............                76  ................         2.4             2.9
94. Thallium **...................    7440280  ............             -       0.000068  ................               116         1.7             6.3
95. Toluene.......................     108883  ............          0.50         0.0097                17  ................          72             130
96. Toxaphene.....................    8001352  ............             -   ............  ................  ................  ..........  ..............
97. Trichloroethylene.............      79016          0.05             -   ............                13  ................         0.3             0.7
98. Vinyl Chloride................      75014           1.5             -   ............               1.7  ................  ..........            0.18
99. Zinc..........................    7440666  ............          0.50            0.3  ................                47       1,000           1,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\a\ This criterion refers to the inorganic form of arsenic only.
\b\ This criterion is expressed as the fish tissue concentration of methylmercury (mg methylmercury/kg fish). See Water Quality Criterion for the
  Protection of Human Health: Methylmercury (EPA-823-R-01-001, January 3, 2001) for how this value is calculated using the criterion equation in EPA's
  2000 Human Health Methodology rearranged to solve for a protective concentration in fish tissue rather than in water.
\c\ This criterion applies to total PCBs (e.g., the sum of all congener or isomer or homolog or Aroclor analyses).
* Bis(2-Chloro-1-Methylethyl) Ether was previously listed as Bis(2-Chloroisopropyl) Ether.
** These criteria were promulgated for Washington in the National Toxics Rule at 40 CFR 131.36, and are moved into 40 CFR 131.45 to have one
  comprehensive human health criteria rule for Washington.

    (c) Applicability. (1) The criteria in paragraph (b) of this
section apply to waters with Washington's designated uses cited in
paragraph (d) of this section and apply concurrently with other
applicable water quality criteria.
    (2) The criteria established in this section are subject to
Washington's general rules of applicability in the same way and to the
same extent as are other federally promulgated and state-adopted
numeric criteria when applied to the same use classifications in
paragraph (d) of this section.
    (i) For all waters with mixing zone regulations or implementation
procedures, the criteria apply at the appropriate locations within or
at the boundary of the mixing zones; otherwise the criteria apply
throughout the waterbody including at the end of any discharge pipe,
conveyance or other discharge point within the waterbody.
    (ii) The state must not use a low flow value below which numeric
non-carcinogen and carcinogen human health criteria can be exceeded
that is less stringent than the harmonic mean flow for waters suitable
for the establishment of low flow return frequencies (i.e., streams and
rivers). Harmonic mean flow is a long-term mean flow value calculated
by dividing the number of daily flows analyzed by the sum of the
reciprocals of those daily flows.
    (iii) If the state does not have such a low flow value for numeric
criteria, then none will apply and the criteria in paragraph (b) of
this section herein apply at all flows.
    (d) Applicable use designations. (1) All waters in Washington
assigned to the following use classifications are subject to the
criteria identified in paragraph (d)(2) of this section:
    (i) Fresh waters--
    (A) Miscellaneous uses: Harvesting (Fish harvesting);
    (B) Recreational uses;
    (C) Water supply uses: Domestic water (Domestic water supply);
    (ii) Marine waters--
    (A) Miscellaneous uses: Harvesting (Salmonid and other fish
harvesting, and crustacean and other shellfish (crabs, shrimp,
scallops, etc.) harvesting);
    (B) Recreational uses;
    (C) Shellfish harvesting: Shellfish harvest (Shellfish (clam,
oyster, and mussel) harvesting)

    Note to paragraph (d)(1):  The source of these uses is
Washington Administrative Code 173-201A-600 for Fresh waters and
173-201A-610 for Marine waters.

    (2) For Washington waters that include the use classification of
Domestic Water, the criteria in column C1 and the methylmercury
criterion in column C2 of Table 1 in paragraph (b) of this section
apply. For Washington waters that include any of the following use
classifications but do not include the use classification of Domestic
Water, the criteria in column C2 of Table 1 in paragraph (b) of this
section apply: Harvesting (fresh and marine waters), Recreational Uses
(fresh and marine waters), and Shellfish Harvesting.

[FR Doc. 2016-28424 Filed 11-25-16; 8:45 am]
 BILLING CODE 6560-50-P