[Federal Register Volume 76, Number 3 (Wednesday, January 5, 2011)]
[Notices]
[Pages 596-598]
[FR Doc No: 2010-33252]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-63612; File No. SR-FICC-2010-10]

Self-Regulatory Organizations; Fixed Income Clearing Corporation;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Relating to Modifications to the Fee Schedule

December 29, 2010.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ notice is hereby given that on December 21, 2010, the
Fixed Income Clearing Corporation (``FICC'') filed with the Securities
and Exchange Commission (``Commission'') the proposed rule change as
described in Items I and II, which Items have been prepared primarily
by FICC. FICC filed the proposed rule change pursuant to Section
19(b)(3)(A)(ii) of the Act \2\ and Rule 19b-4(f)(2) \3\ thereunder so
that the proposal was effective upon filing with the Commission. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \3\ 17 CFR 240.19b-4(f)(2).

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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The purpose of this filing is to modify participant fees. The fee
changes are effective as of January 1, 2011.

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

    In its filing with the Commission, FICC 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. FICC 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. Government Securities Division (``GSD'')
    (a) The fee structure for submission of a side of a trade and
submission of a Repo Transaction is revised to reflect the following:

------------------------------------------------------------------------
                                      Current fee      2011 proposed fee
------------------------------------------------------------------------
Up to 50,000 submissions per      $0.21 per item....  $0.27 per item.
 month.
50,001 to 100,000 submissions     $0.12 per item....  $0.15 per item.
 per month.
------------------------------------------------------------------------

     (b) The following Netting Fee and Charges have been revised as
follows:

------------------------------------------------------------------------
                                      Current fee      2011 proposed fee
------------------------------------------------------------------------
1. For each side of a Compared    (i) $0.16; and      (i) $0.18; and
 Trade, other than a Repo         (ii) $0.016 per $1  (ii) $0.018 per $1
 Transaction, that is netted, a    million of par      million of par
 fee equaling the sum (in          value..             value.
 addition to the comparison fee)
 of:
2. For each Start Leg or Close    (i) $0.16; and      (i) $0.18; and
 Leg of a Repo Transaction other  (ii) $0.016 per $1  (ii) $0.018 per $1
 than a GCF Repo Transaction       million of par      million of par
 that is netted, a fee equaling    value..             value.
 the sum (in addition to the
 comparison fee) of:
------------------------------------------------------------------------

     (c) Currently, the charge to a member for the processing and
reporting by the GSD of a GCF Repo[supreg] transaction is $.05 per
million gross dollar amount of such transaction with a minimum charge
of $2.50. The current charge makes no distinction between inter-dealer
broker members and non-inter-dealer broker members. The proposed new
charge will apply different charges to inter-dealer broker members and
non-inter-dealer broker members. Specifically, the charge for non-
inter-dealer broker members will remain unchanged at $.05 per million
with a minimum charge of $2.50. The charge for inter-dealer brokers
will be $.025 per million with a minimum charge of $1.25.
    (d) The charge for each Deliver Obligation and Receive Obligation
created as a result of the netting process is a fee of $0.10 per $1
million of par value. This fee is being increased to $0.15 per $1
million.
    (e) Repo Transaction Processing Fee.
    a. For a term Repo Transaction other than a GCF Repo Transaction
that has been compared and netted, but which has not yet settled, a fee
calculated as follows:
    i. For Repo Brokers (as defined in subsection III.H of the GSD Fee
Structure) with respect to their brokered Repo Transaction activity, a
.010 basis point charge (i.e., one hundredth of a basis point) applied
to the gross dollar amount of each such Repo Transaction is currently
in effect. This will be increased to 0.0175 basis point charge (i.e.
one and three quarter hundredth of a basis point) and
    ii. For all other Netting Members, as well as Repo Brokers with
respect to their non-brokered Repo Transaction activity, a .020 basis
point charge (i.e., two hundredths of a basis point) applied to the
gross dollar amount of each such Repo Transaction is currently in
effect. This will be increased to a 0.025 basis point charge (i.e. two
and a half hundredth of a basis point).
    b. For a GCF Repo Transaction that has been compared and netted,
but which has not yet settled, a fee calculated as follows:
    i. For Repo Brokers acting as GCF-Authorized-Inter-Dealer Brokers,
a .010 basis point charge (i.e., one hundredth of a basis point)
applied to the gross dollar amount of such GCF Repo Transaction. This
will be increased to 0.0175 basis point charge (i.e., one and three
quarter hundredths of a basis point) applied to the gross dollar amount
of such GCF Repo Transaction and
    ii. For all other Netting Members, a .020 basis point charge (i.e.,
two hundredths of a basis point) applied to the gross dollar amount of
such GCF Repo Transaction. This will be increased to 0.025 basis point
charge (i.e., two and one half hundredths of a basis point) applied to
the gross dollar amount of such GCF Repo Transaction.
2. Mortgage Backed Securities Division (``MBSC'') Fee Changes
    The MBSD fee structure is revised to reflect the following:

------------------------------------------------------------------------
                                    Current old fee    2011 proposed fee
                                 ---------------------------------------
                                       Par value           Par value
                                       millions            millions
------------------------------------------------------------------------
Up to 2,500 trades per month....               $1.44               $1.68
2,501 to 5,000 trades per month.                1.32                1.54

5,001 to 7,500 trades per month.                1.19                1.39
7,501 to 10,000 trades per month                1.11                1.30
10,001 to 12,500 trades per                     0.98                1.15
 month..........................
12,501 and over trades per month                0.85                0.99
------------------------------------------------------------------------

    FICC states that the proposed rule change is consistent with the
requirements of Section 17A of the Act \4\ and the rules and
regulations thereunder because it updates FICC's fee schedule and
provides for the equitable allocation of fees among its participants.
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    \4\ 15 U.S.C. 78q-1.
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B. Self-Regulatory Organization's Statement on Burden on Competition

    FICC does not believe that the proposed rule change will have any
impact or impose any burden on competition.

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

    FICC has not solicited or received written comments relating to the
proposed rule change. FICC will notify the Commission of any comments
it receives.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act \5\ and Rule 19b-4(f)(2) \6\ because the
proposed rule change establishes or changes a due, fee, or other charge
applicable only to a member. 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
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    \5\ Supra note 2.
    \6\ Supra note 3.
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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 e-mail to<EMAIL_ADDRESS>Please include
File No. SR-FICC-2010-10 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File No. SR-FICC-2010-10. This file
number should be included on the subject line if e-mail 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
a.m. and 3 p.m. Copies of such filings also will be available for
inspection and copying at FICC's principal office and on FICC's Web
site at http://www.dtcc.com/legal/rule_filings/ficc/2010.php. 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
submission should refer to File No. SR-FICC-2010-10 and should be
submitted on or before January 26, 2011.

    For the Commission by the Division of Trading and Markets
pursuant to delegated authority.\7\
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    \7\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-33252 Filed 1-4-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 147 (Wednesday, July 31, 2013)]
[Rules and Regulations]
[Pages 46256-46258]
[FR Doc No: 2013-18395]

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SECURITIES AND EXCHANGE COMMISSION

17 CFR Part 232

[Release Nos. 33-9433, 34-70040, 39-2491, IC-30629]

Adoption of Updated EDGAR Filer Manual

AGENCY: Securities and Exchange Commission.

ACTION: Final rule.

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SUMMARY: The Securities and Exchange Commission (the Commission) is
adopting revisions to the Electronic Data Gathering, Analysis, and
Retrieval System (EDGAR) Filer Manual and related rules to reflect
updates to the EDGAR system. The revisions are being made primarily to
introduce the new EDGARLink Online submission form type SD (Specialized
Disclosure Report) and SD/A; support minor updates to Form 13H. The
EDGAR system is scheduled to be upgraded to support this functionality
on July 22, 2013.

DATES: Effective July 31, 2013. The incorporation by reference of the
EDGAR Filer Manual is approved by the Director of the Federal Register
as of July 31, 2013.

FOR FURTHER INFORMATION CONTACT: In the Division of Corporation
Finance, for questions concerning submission form type SD and SD/A
contact Heather Mackintosh at<PHONE_NUMBER>; in the Division of
Trading and Markets for questions concerning Form 13H contact Richard
Holley; and in the Office of Information Technology, contact Vanessa
Anderson at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: We are adopting an updated EDGAR Filer
Manual, Volume II. The Filer Manual describes the technical formatting
requirements for the preparation and submission of electronic filings
through the EDGAR system.\1\ It also describes the requirements for
filing using EDGARLink Online and the Online Forms/XML Web site.
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    \1\ We originally adopted the Filer Manual on April 1, 1993,
with an effective date of April 26, 1993. Release No. 33-6986 (April
1, 1993) [58 FR 18638]. We implemented the most recent update to the
Filer Manual on May 14, 2013. See Release No. 33-9403 (May 21, 2013)
[78 FR 29616].
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    The revisions to the Filer Manual reflect changes within Volume II
entitled EDGAR Filer Manual, Volume II: ``EDGAR Filing,'' Version 24
(July 2013). The updated manual will be incorporated by reference into
the Code of Federal Regulations.
    The Filer Manual contains all the technical specifications for
filers to submit filings using the EDGAR system. Filers must comply
with the applicable provisions of the Filer Manual in order to assure
the timely acceptance and processing of filings made in electronic
format.\2\ Filers may consult the Filer Manual in conjunction with our
rules governing mandated electronic filing when preparing documents for
electronic submission.\3\
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    \2\ See Rule 301 of Regulation S-T (17 CFR 232.301).
    \3\ See Release No. 33-9403 (May 21, 2013) [78 FR 29616] in
which we implemented EDGAR Release 13.1. For additional history of
Filer Manual rules, please see the cites therein.
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    The EDGAR system will be upgraded to Release 13.2 on July 22, 2013
and will introduce the following changes: EDGAR will be updated to
introduce submission form types, SD (Specialized Disclosure Report) and
SD/A on EDGAR Filing Web site for filing disclosure under Exchange Act
Sections 13(p) and the related rule regarding the use of conflict
minerals. These submission form types will be available on the
EDGARLink Online application. Filers may also construct submissions by
following the `EDGARLink Online XML Technical Specification', available
on the Commission's public Web site's ``Information for EDGAR Filers''
Web page.
    Form SD Item 1.02 (Conflict Minerals Report) will require issuers
to provide the Conflict Minerals Report as Exhibit 1.02 in ASCII or
HTML format. See Final Release No. 34-67716.
    EDGAR will be updated to allow Form 13H filers to use the 13H-A
submission form type to satisfy both their annual and fourth quarter
amendment filing requirements. Filers will be able to submit form type
13H-A as their annual (13H-A) and fourth quarter amendment (13H-Q)
submissions. Additionally, submission form types 13H, 13H-A and 13H-Q
will be updated to increase the maximum number of characters accepted
by Item 1(b) to 20,000 characters and increase the number of broker-
dealers that can be provided under Item 6 to 2000.
    Along with the adoption of the Filer Manual, we are amending Rule
301 of Regulation S-T to provide for the incorporation by reference
into the Code of Federal Regulations of today's revisions. This
incorporation by reference was approved by the Director of the Federal
Register in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51.
    You may obtain paper copies of the updated Filer Manual at the
following address: Public Reference Room, U.S. Securities and Exchange
Commission, 100 F Street NE., Room 1543, Washington, DC 20549, on
official business days between the hours of 10:00 a.m. and 3:00 p.m. We
will post electronic format copies on the Commission's Web site; the
address for the Filer Manual is http://www.sec.gov/info/edgar.shtml.
    Since the Filer Manual and the corresponding rule changes relate
solely to agency procedures or practice, publication for notice and
comment is not required under the Administrative Procedure Act
(APA).\4\ It follows that the requirements of the Regulatory
Flexibility Act \5\ do not apply.
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    \4\ 5 U.S.C. 553(b).
    \5\ 5 U.S.C. 601-612.
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    The effective date for the updated Filer Manual and the rule
amendments is July 31, 2013. In accordance with the APA,\6\ we find
that there is good cause to establish an effective date less than 30
days after publication of these rules. The EDGAR system upgrade to
Release 13.2 is scheduled to become available on July 22, 2013. The
Commission believes that establishing an effective date less than 30
days after publication of these rules is necessary to coordinate the
effectiveness of the updated Filer Manual with the system upgrade.
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    \6\ 5 U.S.C. 553(d)(3).
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Statutory Basis

    We are adopting the amendments to Regulation S-T under Sections 6,
7, 8, 10, and 19(a) of the Securities Act of 1933,\7\ Sections 3, 12,
13, 14, 15, 23, and 35A of the Securities Exchange Act of 1934,\8\
Section 319 of the Trust Indenture Act of 1939,\9\ and Sections 8, 30,
31, and 38 of the Investment Company Act of 1940.\10\
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    \7\ 15 U.S.C. 77f, 77g, 77h, 77j, and 77s(a).
    \8\ 15 U.S.C. 78c, 78l, 78m, 78n, 78o, 78w, and 78ll.
    \9\ 15 U.S.C. 77sss.
    \10\ 15 U.S.C. 80a-8, 80a-29, 80a-30, and 80a-37.
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List of Subjects in 17 CFR Part 232

    Incorporation by reference, Reporting and recordkeeping
requirements, Securities.

Text of the Amendment

    In accordance with the foregoing, Title 17, Chapter II of the Code
of Federal Regulations is amended as follows:

PART 232--REGULATION S-T--GENERAL RULES AND REGULATIONS FOR
ELECTRONIC FILINGS

0
1. The authority citation for Part 232 continues to read in part as
follows:

    Authority: 15 U.S.C. 77f, 77g, 77h, 77j, 77s(a), 77z-3,
77sss(a), 78c(b), 78l, 78m, 78n, 78o(d), 78w(a), 78ll, 80a-6(c),
80a-8, 80a-29, 80a-30, 80a-37, and 7201 et seq.; and 18 U.S.C. 1350.
* * * * *

0
2. Section 232.301 is revised to read as follows:

Sec.  232.301  EDGAR Filer Manual.

    Filers must prepare electronic filings in the manner prescribed by
the EDGAR Filer Manual, promulgated by the Commission, which sets out
the technical formatting requirements for electronic submissions. The
requirements for becoming an EDGAR Filer and updating company data are
set forth in the EDGAR Filer Manual, Volume I: ``General Information,''
Version 15 (May 2013). The requirements for filing on EDGAR are set
forth in the updated EDGAR Filer Manual, Volume II: ``EDGAR Filing,''
Version 24 (July 2013). Additional provisions applicable to Form N-SAR
filers are set forth in the EDGAR Filer Manual, Volume III: ``N-SAR
Supplement,'' Version 2 (August 2011). All of these provisions have
been incorporated by reference into the Code of Federal Regulations,
which action was approved by the Director of the Federal Register in
accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. You must comply with
these requirements in order for documents to be timely received and
accepted. You can obtain paper copies of the EDGAR Filer Manual from
the following address: Public Reference Room, U.S. Securities and
Exchange Commission, 100 F Street NE., Room 1543, Washington, DC 20549,
on official business days between the hours of 10:00 a.m. and 3:00 p.m.
Electronic copies are available on the Commission's Web site. The

address for the Filer Manual is http://www.sec.gov/info/edgar.shtml.
You can also inspect the document at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

    By the Commission.

    Dated: July 25, 2013.

Elizabeth M. Murphy,
Secretary.
[FR Doc. 2013-18395 Filed 7-30-13; 8:45 am]
BILLING CODE 8011-01-P


1 Preliminary Model Testing and Next Steps Time To Death 0 100 200 300 400 500 Hours Dead/

Hr PDF ( Probability of N Deaths/ 25)

0.00 0.05 0.10 0.15 0.20 0 5 10 15 20 25 Number Dead Probability Mean Fraction of Total Dose by Pathway for Fatalities 0 0.2 0.4 0.6 0.8 Dose fraction by Pathway Food Puddle Dew Inhal: Vapor Inhal: Spray Dermal: Contact Dermal: Spray 2 Model Test Setup Row Crop/ 0.1 vs 0.3 Crop type/ height ( m)

Chemical Properties 0.77 Pan Evaporation Rate ( cm/ day)

Meteorology 8 am Hour of Application 3 Rainfall Duration ( hours) 0.75 Rate ( lbs/ A) 2.17E 07 Henry's Law Constant( atm/ m3/ mol) Insects 3.19 Forage 2.72 Wildlife Food Idem ½ life ( days) 24 Rain Lag ( hours after application) 1 Rainfall ( cm) Ground Method Application Method and Rate Input Model Parameter 3 Model Test Setup cont.

2.72 Foliar Dissipation Half life ( Days) 9.1 Bird Oral LD 50 ( mg/ kg)

Toxicological Properties 7.8E 06 Dislodgeable Foliar Residue Adj. Factor 30 K ow Yes Rain Fall Included H 2 O 28 Soil 28 Water and Soil ½ Life ( days) 9.6 Rat Acute Inhalation LD 50 ( mg/ kg) 5.7 slope Field Resident Insectivore Generic Species 1.9 Dislodgeable Foliar Residue ½ Life( days) 37.9 K oc Chemical Properties cont. Input Model Parameter 4 0.928 Pesticide Retention Rate ( fraction of dose/ hr) No data Bird Dermal LD 50 ( mg/ kg) 6.0 Rat Acute Oral LD 50 ( mg/ kg)

Toxicological Properties cont. Input Model Parameter Model Test Setup cont. 5 Preliminary Model Testing Crop Height > 0.15 Exposure Pathway Switches Food Ingestion On Puddle On Dew On Inhalation: Vapor On Inhalation: Spray On Dermal Contact On Dermal Spray On 6 Preliminary Model Testing Results Crop Height > 0.15 m Minimum Maximum Mean SD Food Ingestion 0 0.869 0.197 0.179 Puddle 0 0.918 0.353 0.237 Dew 0 0.487 0.013 0.033 Inhalation: Vapor 0 0.072 0.02 0.014 Inhalation: Spray 0 0.106 0.03 0.02 Dermal Contact 0 0.512 0.129 0.063 Dermal Spray 0 0.998 0.258 0.171 Fractional Dose Distribution by Pathway ( dead birds) Mean Fraction of Total Dose by Pathway for Fatalities 0 0.1 0.2 0.3 0.4 Dose fraction by Pathway Food Puddle Dew Inhal: Vapor Inhal: Spray Dermal: Contact Dermal: Spray 7 Birds: 10,000 Birds with no exposures: 1 Dead Birds: 3,519 Risk 0.35193 Adjusted Risk 0.35196 Testing Results Crop Height > 0.15 m CCDF ( Probability of N or More Deaths/ 25)

0 0.2 0.4 0.6 0.8 1 0 5 10 15 20 25 Number Dead Probability PDF ( Probability of N Deaths/ 25)

0.00 0.05 0.10 0.15 0.20 0 5 10 15 20 25 Number Dead Probability Time To Death 0 1000 2000 3000 Hours Dead/

Hr Mean dead per 25 = 8.8 S. D = 2.4 Direct Dermal Spray Puddle as Drinking Water Source 8 Preliminary Model Testing Results Crop Height < 0.15 Exposure Pathway Switches Food Ingestion On Puddle On Dew On Inhalation: Vapor Off Inhalation: Spray Off Dermal Contact Off Dermal Spray Off 9 Test Results Crop Height < .15 m Minimum Maximum Mean SD Food Ingestion 0 1 0.327 0.294 Puddle 0 1 0.658 0.301 Dew 0 0.96 0.015 0.038 Inhalation: Vapor 0 0 0 0 Inhalation: Spray 0 0 0 0 Dermal Contact 0 0 0 0 Dermal Spray 0 0 0 0 Mean Fraction of Total Dose by Pathway for Fatalities 0 0.2 0.4 0.6 0.8 Dose fraction by Pathway Food Puddle Dew Inhal: Vapor Inhal: Spray Dermal: Contact Dermal: Spray 10 Test Results Crop Height < .15 m Birds: 10,000 Birds with no exposures: 0 Dead Birds: 2,500 Risk 0.25005 Adjusted Risk 0.25005 CCDF ( Probability of N or More Deaths/ 25)

0 0.2 0.4 0.6 0.8 1 0 5 10 15 20 25 Number Dead Probability PDF ( Probability of N Deaths/ 25)

0.00 0.05 0.10 0.15 0.20 0 5 10 15 20 25 Number Dead Probability Time To Death 0 500 1000 1500 2000 2500 Hours Dead/

Hr Mean dead per 25 = 6.3 S. D = 2.1 Puddle as Drinking Water Source 11 Preliminary Model Testing Results Crop Height > 0.15, No Rainfall Exposure Pathway Switches Food Ingestion On Puddle Off Dew On Inhalation: Vapor On Inhalation: Spray On Dermal Contact On Dermal Spray On 12 Crop Height < .15 m No Rain Minimum Maximum Mean SD Food Ingestion 0 0.929 0.404 0.24 Puddle 0 0 0 0 Dew 0 0.421 0.025 0.047 Inhalation: Vapor 0 0.09 0.028 0.019 Inhalation: Spray 0 0.129 0.04 0.028 Dermal Contact 0 0.447 0.146 0.107 Dermal Spray 0 0.881 0.356 0.244 Mean Fraction of Total Dose by Pathway for Fatalities 0 0.1 0.2 0.3 0.4 0.5 Dose fraction by Pathway Food Puddle Dew Inhal: Vapor Inhal: Spray Dermal: Contact Dermal: Spray 13 Crop . 0.15 No Rain Birds: 10,000 Birds with no exposures: 0 Dead Birds: 1,158 Risk 0.11588 Adjusted Risk 0.11588 CCDF ( Probability of N or More Deaths/ 25)

0 0.2 0.4 0.6 0.8 1 0 5 10 15 20 25 Number Dead Probability PDF ( Probability of N Deaths/ 25)

0.00 0.05 0.10 0.15 0.20 0 5 10 15 20 25 Number Dead Probability Time To Death 0 100 200 300 400 Hours Dead/

Hr Direct Dermal Spray Mean dead per 25 = 2.8 S. D = 1.7 14 Preliminary Model Testing Crop Height > 0.15, Water/ Soil ½ Life = 1 day Minimum Maximum Mean SD Food Ingestion 0 0.908 0.244 0.198 Puddle 0 0.881 0.29 0.218 Dew 0 0.764 0.016 0.042 Inhalation: Vapor 0 0.064 0.018 0.011 Inhalation: Spray 0 0.04 0.011 0.007 Dermal Contact 0.001 0.573 0.15 0.071 Dermal Spray 0 0.908 0.271 0.167 Mean Fraction of Total Dose by Pathway for Fatalities 0 0.1 0.2 0.3 0.4 Dose fraction by Pathway Food Puddle Dew Inhal: Vapor Inhal: Spray Dermal: Contact Dermal: Spray 15 Crop Height > 0.15,

Water/ Soil ½ Life = 1 day Birds: 10,000 Birds with no exposures: 0 Dead Birds: 2,744 Risk 0.27445 Adjusted Risk 0.27445 CCDF ( Probability of N or More Deaths/ 25)

0 0.2 0.4 0.6 0.8 1 0 5 10 15 20 25 Number Dead Probability PDF ( Probability of N Deaths/ 25)

0.00 0.05 0.10 0.15 0.20 0 5 10 15 20 25 Number Dead Probability Time To Death 0 500 1000 1500 2000 Hours Dead/

Hr Mean dead per 25 = 6.8 S. D = 2.2 16 Summary of Preliminary Testing of Model Output on Influence of Crop Height, Rainfall, and H2O & Soil ½ Life Mean Fraction Dose By Pathway 0.27 0.15 0.29 0.24 0.27 Crop > 0.15 Rain H 2 O/ Soil ½ life 1 day 0.36 0.15 0 0.40 0.11 Crop > 0.15 m No Rain H 2 O/ Soil ½ life 28 days 0 0 0.67 0.32 0.25 Crop < 0.15 m Rain H 2 O/ Soil ½ life 28 days 0.26 0.13 0.35 0.20 0.35 Crop > 0.15 m Rain H 2 O/ Soil ½ life 28 days Dermal Spray Dermal Con Pud Food Risk Scenario Ground Appl., 0.75 lb/ A, Field Resident Insectivore.

LD50 = 9.1mg/ kg, Slope 5.7 17 Next Steps for Moving Toward Implementation ° Complete Parameterization of Model ° Complete Testing of Code ° Conduct Sensitivity Analysis ° Complete Documentation of Model ° Develop User Manual ° Conduct Beta Testing ° Modify Model and Supporting Materials ° QA/ QC Model and Supporting Materials ° Initiate Training of Staff Scientists 18 Future Model Developments ° Expand model to address additional application methods and formulations ( baits, granular products,

etc.)

° Expand Model to address reproductive impairment from pesticide exposures ° Expand model to address other taxonomic groups ( mammals, reptiles, amphibians)

° Develop Links of Model outputs directly with Population Models under development


[Federal Register Volume 82, Number 22 (Friday, February 3, 2017)]
[Rules and Regulations]
[Pages 9166-9174]
[FR Doc No: 2017-02283]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 131

[EPA-HQ-OW-2016-0012; FRL-9958-40-OW]
RIN 2040-AF60

Aquatic Life Criteria for Cadmium in Oregon

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is establishing a
federal Clean Water Act (CWA) aquatic life criterion for freshwaters
under the state of Oregon's jurisdiction, to protect aquatic life from
the effects of exposure to harmful levels of cadmium. In 2013, EPA
determined that the freshwater acute cadmium criterion and freshwater
acute and chronic copper criteria that Oregon adopted in 2004 did not
meet CWA requirements to protect aquatic life in the state. Since that
time, the state adopted revised criteria for copper (which EPA is
approving in parallel with this final rulemaking), but has not adopted
a revised acute criterion for cadmium and thus EPA is establishing a
federal freshwater acute criterion for cadmium that takes into account
the best available science, EPA policies, guidance and legal
requirements, to protect aquatic life uses in Oregon.

DATES: This final rule is effective on March 6, 2017.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-HQ-OW-2016-0012. All documents in the docket are listed on the
http://www.regulations.gov Web site. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available electronically through http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Erica Fleisig, Office of Water,
Standards and Health Protection Division (4305T), Environmental
Protection Agency, 1200 Pennsylvania Avenue NW., Washington, DC 20460;
telephone number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This final rule is organized as follows:

I. General Information
    A. Does this action apply to me?
    B. How did EPA develop this final rule?
II. Background
    A. Statutory and Regulatory Background
    B. EPA's Actions on Oregon's Freshwater Copper and Cadmium
Criteria
    C. General Recommended Approach for Deriving Aquatic Life
Criteria
III. Freshwater Cadmium Aquatic Life Criteria
    A. EPA's National Recommended Cadmium Criteria
    B. Final Acute Cadmium Criterion for Oregon's Freshwaters
    C. Additional Considerations for Calculation of Site-Dependent
Cadmium Criteria
IV. Implementation of Final Cadmium Criterion in Oregon
V. Critical Low-Flows and Mixing Zones
VI. Endangered Species Act
VII. Applicability of Criteria
VIII. Alternative Regulatory Approaches and Implementation
Mechanisms
    A. Designating Uses
    B. Site-Specific Criteria
    C. Variances
    D. Compliance Schedules
IX. Economic Analysis
    A. Identifying Affected Entities
    B. Method for Estimating Costs
    C. Results
X. Statutory and Executive Order Reviews
    A. Executive Order 12866 (Regulatory Planning and Review) and
Executive Order 13563 (Improving Regulation and Regulatory Review)
    B. Paperwork Reduction Act
    C. Regulatory Flexibility Act
    D. Unfunded Mandates Reform Act
    E. Executive Order 13132 (Federalism)
    F. Executive Order 13175 (Consultation and Coordination With
Indian Tribal Governments)
    G. Executive Order 13045 (Protection of Children From
Environmental Health and Safety Risks)
    H. Executive Order 13211 (Actions That Significantly Affect
Energy Supply, Distribution, or Use)
    I. National Technology Transfer and Advancement Act of 1995

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

I. General Information

A. Does this action apply to me?

    Cadmium naturally occurs at low levels in surface waters, but
anthropogenic activities can increase levels of cadmium in the
environment. At higher concentrations, cadmium can be toxic to aquatic
life. Sources of elevated cadmium in the environment include coal
combustion, mining, electroplating, iron and steel production, and use
of pigments, fertilizers and pesticides. Industrial facilities,
stormwater management districts, or publicly owned treatment works
(POTWs) that discharge pollutants to freshwaters of the United States
under the state of Oregon's jurisdiction could be indirectly affected
by this rulemaking, because federal water quality standards (WQS)
promulgated by EPA are applicable to CWA regulatory programs, such as
National Pollutant Discharge Elimination System (NPDES) permitting.
Citizens concerned with water quality in Oregon could also be
interested in this rulemaking. Categories and entities that could
potentially be affected include the following:

----------------------------------------------------------------------------------------------------------------
                          Category                                 Examples of potentially affected entities
----------------------------------------------------------------------------------------------------------------
Industry....................................................  Industrial facilities discharging pollutants to
                                                               freshwaters of the United States in Oregon.
Municipalities..............................................  Publicly owned treatment works or other facilities
                                                               discharging pollutants to freshwaters of the
                                                               United States in Oregon.
Stormwater Management Districts.............................  Entities responsible for managing stormwater
                                                               runoff in the state of Oregon.
----------------------------------------------------------------------------------------------------------------

This table is not intended to be exhaustive, but rather provides a
guide for readers regarding entities that could be indirectly affected
by this action. Any parties or entities who depend upon or contribute
to the water quality of Oregon's waters could be indirectly affected by
this rule. To determine whether your facility or activities could be
indirectly affected by this action, you should carefully examine this
rule. If you have questions regarding the applicability of this action
to a particular entity, consult the person listed in the FOR FURTHER
INFORMATION CONTACT section.

B. How did EPA develop this final rule?

    In developing this final rule, EPA carefully considered the public
comments and feedback received from interested parties. EPA originally
provided a 45-day public comment period after publishing the proposed
rule in the Federal Register on April 18, 2016.\1\ In addition, EPA
held two public hearings on May 16 and 17, 2016, to provide
clarification on the contents of the proposed rule and accept verbal
public comments.
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    \1\ See Aquatic Life Criteria for Copper and Cadmium in Oregon:
Proposed Rule, 81 FR 22555, April 18, 2016.
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    Fourteen organizations and individuals submitted comments on a
range of issues prior to the close of the public comment period on June
2, 2016. Some comments addressed issues beyond the scope of the
rulemaking, and thus EPA did not consider them in finalizing this rule.
In each section of this preamble, EPA discusses certain public comments
so that the public is aware of the Agency's position. For a full
response to these and all other comments, see EPA's Response to
Comments document in the official public docket.

II. Background

A. Statutory and Regulatory Background

    CWA section 101(a)(2) establishes as a national goal ``wherever
attainable . . . water quality which provides for the protection and
propagation of fish, shellfish, and wildlife and provides for
recreation in and on the water. . . .'' These are commonly referred to
as the ``fishable/swimmable'' goals of the CWA.
    CWA section 303(c) (33 U.S.C. 1313(c)) directs states to adopt WQS
for their waters subject to the CWA. CWA section 303(c)(2)(A) and EPA's
implementing regulations at 40 CFR part 131 require, among other
things, that a state's WQS specify appropriate designated uses of the
waters, and water quality criteria that protect those uses. EPA's
regulations at 40 CFR 131.11(a)(1) provide that ``[s]uch criteria must
be based on sound scientific rationale and must contain sufficient
parameters or constituents to protect the designated use. For waters
with multiple use designations, the criteria shall support the most
sensitive use.'' In addition, 40 CFR 131.10(b) provides that ``[i]n
designating uses of a water body and the appropriate criteria for those
uses, the [s]tate shall take into consideration the water quality
standards of downstream waters and shall ensure that its water quality
standards provide for the attainment and maintenance of the water
quality standards of downstream waters.''
    States are required to review applicable WQS at least once every
three years and, if appropriate, revise or adopt new standards (CWA
section 303(c)(1)). Any new or revised WQS must be submitted to EPA for
review and approval or disapproval (CWA section 303(c)(2)(A) and
(c)(3)). If EPA disapproves a state's new or revised WQS, the CWA
provides the state 90 days to adopt a revised WQS that meets CWA
requirements, and if it fails to do so, EPA shall promptly propose and
then within 90 days promulgate such standard unless EPA approves a
state replacement WQS first (CWA section 303(c)(3) and (c)(4)(A)). CWA
section 303(c)(4)(B) authorizes the Administrator to determine that a
new or revised standard is needed to meet CWA requirements. Upon making
such a determination, the CWA specifies that EPA shall promptly
propose, and then within 90 days promulgate, any such new or revised
standard unless prior to such promulgation, the state has adopted a
revised or new WQS that EPA determines to be in accordance with the
CWA.
    Under CWA section 304(a), EPA periodically publishes criteria
recommendations for states to consider when adopting water quality
criteria for particular pollutants to meet the CWA section 101(a)(2)
goal uses. In establishing criteria, states should establish numeric
water quality criteria based on EPA's CWA section 304(a) criteria,
section 304(a) criteria modified to reflect site-specific conditions,
or other scientifically defensible methods (40 CFR 131.11(b)(1)). In
all cases criteria must be sufficient to protect the designated use and
be based on sound scientific rationale (40 CFR 131.11(a)(1)).

B. EPA's Actions on Oregon's Freshwater Copper and Cadmium Criteria

    As discussed in the preamble to EPA's proposed rule (81 FR 22555;
April 18, 2016), EPA disapproved several of Oregon's revised aquatic
life criteria

under CWA 303(c), including an acute cadmium freshwater criterion, and
acute and chronic freshwater copper criteria that the National Marine
Fisheries Service (NMFS) concluded would jeopardize endangered species
in Oregon in its biological opinion dated August 14,
2012.2 3 On November 14, 2016, Oregon submitted revised
freshwater copper criteria to EPA for review under CWA section 303(c).
In parallel with this final rule, EPA is taking action under CWA 303(c)
to approve the freshwater copper aquatic life criteria submitted by
Oregon. Oregon did not adopt a revised acute cadmium criterion,
however, therefore EPA is finalizing the freshwater acute cadmium
criterion in this rule in accordance with CWA section 303(c)(3) and
(c)(4) requirements.
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    \2\ See USEPA. 2013. EPA Clean Water Act 303(c) Determinations
On Oregon's New and Revised Aquatic Life Toxic Criteria Submitted on
July 8, 2004, and as Amended by Oregon's April 23, 2007 and July 21,
2011 Submissions. Page 46.
    \3\ The NMFS biological opinion contained Reasonable and Prudent
Alternatives (RPAs) that would avoid the likelihood of jeopardy to
the species. For acute cadmium, the RPA specified a process for
deriving revised freshwater criteria.
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C. General Recommended Approach for Deriving Aquatic Life Criteria

    As discussed in the preamble to the 2016 proposed rule (81 FR
22555), to derive criteria for the protection of aquatic life, EPA
follows its Guidelines for Deriving Numerical National Water Quality
Criteria for the Protection of Aquatic Organisms and Their Uses
(referred to as the ``1985 Guidelines'').\4\ These guidelines describe
an objective way to estimate the highest concentration of a substance
in water that will not present a significant risk to the aquatic
organisms in the water.
---------------------------------------------------------------------------

    \4\ USEPA. 1985. Guidelines for Deriving Numerical National
Water Quality Criteria for the Protection of Aquatic Organisms and
Their Uses. U.S. Environmental Protection Agency, Office of Research
and Development, Duluth, MN, Narragansett, RI, Corvallis, OR. PB85-
227049. https://www.epa.gov/wqc/guidelines-deriving-numerical-national-water-quality-criteria-protection-aquatic-organisms-and.
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    Numeric criteria derived using EPA's 1985 Guidelines are expressed
as short-term (acute) and long-term (chronic) values. The combination
of a criteria maximum concentration (CMC), a one-hour average value,
and a criteria continuous concentration (CCC), a four-day average
value, protects aquatic life from acute and chronic toxicity,
respectively. Neither value is to be exceeded more than once in three
years. EPA selected the CMC's one-hour averaging period because high
concentrations of certain pollutants can cause death in one to three
hours, and selected the CCC's four-day averaging period to prevent
increased adverse effects on sensitive life stages. EPA based the once
every three years exceedance frequency recommendation on the ability of
aquatic ecosystems to recover from the exceedances (when the average
concentration over the duration of the averaging period is above the
CCC or the CMC).\5\
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    \5\ See USEPA, 1985. Pages. 5-7.
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    Because fresh and salt waters have different chemical compositions
and different species assemblages, it is necessary to derive separate
acute and chronic criteria for fresh and salt waters. Additionally,
criteria may be based on certain water characteristics (e.g., pH,
temperature, hardness, dissolved organic carbon (DOC), etc.) because
water chemistry can influence a pollutant's bioavailability and
toxicity. For metals in particular, EPA recommends expressing the
criteria as functions of chemical constituents of the water, because
those constituents can form complexes with metals and render the metals
biologically unavailable, or compete with metals for binding sites on
aquatic organisms. Additionally, in 1995, EPA recommended that criteria
for metals be expressed as dissolved (rather than total) metal
concentrations, because the concentration of dissolved metal better
approximates the toxic fraction.\6\
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    \6\ Water Quality Standards; Establishment of Numeric Criteria
for Priority Toxic Pollutants; States' Compliance--Revision of
Metals Criteria, May 4, 1995, 60 FR 22229.
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III. Freshwater Cadmium Aquatic Life Criteria

A. EPA's National Recommended Cadmium Criteria

    Water hardness (determined by the presence of calcium and magnesium
ions, and expressed as calcium carbonate, CaCO3) affects the
toxicity of cadmium, as calcium and magnesium ions compete with cadmium
for binding sites on aquatic organisms' gills. Organisms show more
sensitivity to cadmium in lower hardness (soft) water than in hard
water. EPA therefore expresses the national 304(a) recommended acute
and chronic cadmium criteria as functions of water hardness.
    On March 30, 2016, EPA announced publication of final updated
304(a) national recommended aquatic life criteria for cadmium.\7\ The
2016 cadmium 304(a) criteria reflect the best available science,
including the results of laboratory aquatic toxicity tests for 75 new
species. EPA lowered the updated 304(a) recommended freshwater acute
cadmium criterion to protect commercially and recreationally important
salmonids, consistent with EPA's 1985 Guidelines. In addition, EPA
revised the effect of total hardness on cadmium toxicity using the
newly acquired data.
---------------------------------------------------------------------------

    \7\ USEPA. 2016. Aquatic Life Ambient Water Quality Criteria:
Cadmium--2016. U.S. Environmental Protection Agency, Office of
Water, Washington, DC EPA-820-R-16-002.
---------------------------------------------------------------------------

B. Final Acute Cadmium Criterion for Oregon's Freshwaters

    To protect aquatic life in Oregon's freshwaters from acute toxic
effects from cadmium, EPA is promulgating the one-hour average CMC of e
(0.9789 x ln(hardness)-3.866) x CF ([micro]g/L, dissolved),
not to be exceeded more than once every three years. ``CF'' refers to
the conversion factor and is used to convert the total recoverable
concentration to a dissolved concentration, consistent with EPA's
policy on criteria for metals. The equation for the acute cadmium CF is
CF = 1.136672 - [(ln hardness) x (0.041838)]. This is the same
freshwater acute cadmium criterion (and associated CF) as in EPA's
final 2016 national updated 304(a) recommended cadmium criteria. The
(ln hardness) term in both the CMC equation and the CF equation is the
natural logarithm of the ambient water hardness in mg/L
(CaCO3). Commenters were generally supportive of EPA's
proposal to apply the final 2016 national 304(a) recommended acute
cadmium criterion (and associated CF) to freshwaters in Oregon.
    Where site-specific hardness data are unavailable, EPA is
establishing default hardness concentrations (as CaCO3),
based on the 10th percentile of existing hardness concentrations in
waters within each of the nine Level III ecoregions in Oregon. These
ecoregion-specific default hardness concentrations are set forth in
Table 2 in the final regulatory text for Sec.  131.46.
    To determine the default hardness concentrations, EPA used 10th
percentile hardness estimates from Table 4 in USEPA's Recommended
Estimates for Missing Water Quality Parameters for Application in EPA's
Biotic Ligand Model, February 16, 2016

(EPA 820-R-15-106).\8\ EPA elected to rely on the dataset \9\ that
formed the basis for the recommendations in EPA's peer-reviewed Missing
Parameters document to determine the proposed and final defaults for
Oregon. While not the only acceptable dataset, the dataset that EPA
used in its Missing Parameters document is robust and publicly
available, and is therefore a reasonable source of data to determine
scientifically defensible and protective default hardness
concentrations for the acute cadmium criterion. Although EPA is
promulgating these default hardness values to use in the absence of
ambient hardness data, EPA strongly recommends that Oregon collect
sufficiently representative ambient hardness data to determine the
appropriate acute cadmium criterion for a site.
---------------------------------------------------------------------------

    \8\ For a map of Level III ecoregions in the continental United
States, see: https://www.epa.gov/eco-research/level-iii-and-iv-ecoregions-continental-united-states.
    \9\ Data came from several water quality databases including the
Storage and Retrieval Data System, National Waters Information
System (NWIS), Wadeable Stream Assessment, and National River and
Stream Assessment (NRSA) database.
---------------------------------------------------------------------------

    Some commenters were in favor of EPA's decision to include default
input parameters, while others were critical of this approach.
Specifically related to EPA's proposal of a default hardness value for
use with the acute cadmium criterion, some commenters argued that EPA's
proposal of a default hardness value of 25 mg/L was overly conservative
because it is below the lowest existing 10th percentile ecoregional
hardness concentration in Oregon. EPA maintains that it is important to
include default values for hardness to provide clarity to NPDES permit
writers and water body assessors as to the applicable acute cadmium
criterion at the site when there are insufficient ambient hardness data
to adequately characterize the site. The default hardness of 25 mg/L
that EPA proposed in its April 18, 2016 proposed rule (81 FR 22555) is
protective and consistent with Oregon's application of a default
hardness concentration of 25 mg/L if no hardness data are available to
calculate hardness-dependent metals criteria.\10\ However, EPA
recognizes that hardness concentrations vary throughout the state, and
using more refined hardness defaults based on ecoregion-specific data,
rather than a single statewide default hardness value, would also
result in protective criteria in the absence of ambient hardness data.
Therefore, in this rulemaking EPA is finalizing different default
hardness concentrations that correspond to the 10th percentile of
ambient hardness data from each of the nine ecoregions in Oregon.
---------------------------------------------------------------------------

    \10\ Oregon Department of Environmental Quality. 2014.
Methodology for Oregon's 2012 Water Quality Report and List of Water
Quality Limited Waters (Pursuant to Clean Water Act Sections 303(d)
and 305(b) and OAR<PHONE_NUMBER>). Pages 76-77.
---------------------------------------------------------------------------

    Consistent with EPA guidance, the hardness default does not
represent a ``hardness floor'' for the ecoregion; rather, a site's
actual ambient water hardness should be used to calculate the criterion
when sufficiently representative hardness data are available, even if
ambient hardness is below the default hardness concentration.\11\
---------------------------------------------------------------------------

    \11\ USEPA. 2002. National Recommended Water Quality Criteria:
2002. U.S. Environmental Protection Agency, Office of Water,
Washington, DC EPA-822-R-02-047.
---------------------------------------------------------------------------

C. Additional Considerations for Calculation of Site-Dependent Cadmium
Criteria

    Commenters requested that EPA provide additional specificity on the
minimum number of samples required to adequately capture temporal and
spatial variability at a site, and site selection considerations. While
many of these comments were with respect to copper criteria
calculations, EPA agrees that these are important considerations for
cadmium as well. In response to these comments, EPA is providing the
following recommendations.
    The number of samples needed to characterize site variability
depends on several characteristics of the site. The water quality
characteristics that determine the bioavailability of metals, including
cadmium, can vary widely in both space and time, changing with
biological activity, flow, geology, human activities, watershed
landscape, and other features of the water body. For the state to
ensure that the criteria are adequately protective of the most
bioavailable conditions at the site through time, the state should
apply appropriate methods to evaluate how a site's water quality
conditions are expected to vary temporally, and ensure that adequate
monitoring is in place to capture the variability across the site and
through time.
    The state should first demonstrate that the hardness concentrations
used in the calculations are not biased toward less bioavailable
conditions for cadmium by evaluating the hardness data and resultant
acute cadmium criteria that are calculated over time for different
flows and seasons. The state should use appropriate analytical methods,
such as a Monte Carlo \12\ simulation or another analytical tool, to
determine if the monitoring methods are sufficient to capture the
temporal trends, and the resultant calculated criteria are adequate to
represent the most bioavailable conditions over time at the site.
---------------------------------------------------------------------------

    \12\ Given sufficient data, Monte Carlo simulation or equivalent
analysis can be used to determine the probability of identifying the
most bioavailable time period for a series of monitoring scenarios.
From such an analysis, the state can select the appropriate
monitoring regime.
---------------------------------------------------------------------------

    Oregon should consider the following when defining a site to which
to apply criteria for cadmium: (1) Metals are generally persistent, so
calculating the criterion using input parameter values from a location
at or near the discharge point could result in a criterion that is not
protective of areas that are outside of that location, and (2) as the
size of a site increases, the spatial and temporal variability is
likely to increase; thus, more water samples may be required to
adequately characterize the entire site.\13\ Additionally, pursuant to
40 CFR 131.10(b), Oregon must consider downstream WQS when calculating
a protective criterion in upstream waters.
---------------------------------------------------------------------------

    \13\ USEPA. 1994. Interim Guidance on Determination and Use of
Water-Effect Ratios for Metals. U.S. Environmental Protection
Agency, Office of Water, Washington, DC EPA-823-B-94-001. February
1994.
---------------------------------------------------------------------------

    Substantial changes in a site's ambient hardness will likely affect
the bioavailability of and the relevant criterion for cadmium at that
site. In addition, with regular monitoring and a robust, site-specific
dataset, criteria can be developed that more accurately reflect site
conditions than criteria set using default values or limited data sets.
Therefore, EPA recommends that Oregon periodically revisit each water
body's cadmium criterion and re-run the hardness equation when changes
in water chemistry are evident or suspected at a site, and also as
additional monitoring data become available.
    When Oregon calculates cadmium criteria, to promote transparency
and ensure predictable and repeatable outcomes, EPA recommends that the
state make each site's ambient hardness data used in the cadmium
criteria calculations, resultant numeric criteria, and the geographic
extent of the site publicly available on the state's Web site.

IV. Implementation of Final Cadmium Criterion in Oregon

    Because organisms are more sensitive to cadmium when hardness is
low, Oregon should ensure that sufficiently representative ambient
hardness data are collected to have confidence that critical conditions
in the water body are

being adequately captured. When setting Water Quality-Based Effluent
Limitations (WQBELs) for cadmium, Oregon should determine hardness
values that represent the receiving water both upstream of and below
the point of discharge under critical conditions (i.e., low hardness)
when cadmium bioavailability is expected to be greater, such that the
resulting criteria calculations, reasonable potential analyses, and any
effluent limitations will be protective of the entire site at critical
conditions. EPA's NPDES Permit Writers' Manual describes the importance
of determining effluent and receiving water critical conditions,
because if a discharge is controlled so that it does not cause water
quality criteria to be exceeded in the receiving water under critical
conditions, then water quality criteria should be attained under all
other conditions.\14\ The same principle holds for developing a TMDL
target.
---------------------------------------------------------------------------

    \14\ USEPA. 2010. NPDES Permit Writers' Manual. U.S.
Environmental Protection Agency, Office of Water, Washington, DC
EPA-833-K-10-001. September 2010.
---------------------------------------------------------------------------

    For transparency for the public, EPA recommends that Oregon
describe in its NPDES permit factsheets how the numeric criteria were
calculated and used to determine reasonable potential and derive
WQBELs. Similarly for TMDLs, EPA recommends that Oregon describe in the
TMDL document how the numeric criteria were calculated and used to
determine TMDL targets. In the assessment and listing context, EPA
recommends that Oregon describe in its integrated reports how it
calculated numeric criteria to which it compared ambient cadmium
concentrations.

V. Critical Low-Flows and Mixing Zones

    To ensure that the criteria are applied appropriately to protect
Oregon's aquatic life uses, EPA is establishing critical low-flow
values for Oregon to use in calculating the available dilution for the
purposes of determining the need for and establishing WQBELs in NPDES
permits. Dilution is one of the primary mechanisms by which the
concentrations of contaminants in effluent discharges are reduced
following their introduction into a receiving water. Low flows can
exacerbate the effects of effluent discharges because, during a low-
flow event, there is less water available for dilution, resulting in
higher instream pollutant concentrations. If criteria are implemented
using inappropriate critical low-flow values (i.e., values that are too
high), the resulting ambient concentrations could exceed criteria when
low flows occur.\15\
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    \15\ USEPA. 2014. Water Quality Standards Handbook-Chapter 5:
General Policies. U.S. Environmental Protection Agency, Office of
Water. Washington, DC EPA-820-B-14&-004. http://www.epa.gov/sites/production/files/2014-09/documents/handbook-chapter5.pdf.
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    EPA's March 1991 Technical Support Document for Water Quality-based
Toxics Control recommends two methods for calculating acceptable
critical low-flow values: The traditional hydrologically based method
developed by the USGS and a biologically based method developed by
EPA.\16\ The hydrologically based critical low-flow value is determined
statistically using probability and extreme values, while the
biologically based critical low-flow is determined empirically using
the specific duration and frequency associated with the criterion.
---------------------------------------------------------------------------

    \16\ USEPA. 1991. Technical Support Document For Water Quality-
based Toxics Control. U.S. Environmental Protection Agency, Office
of Water, Washington, DC EPA/505/2-90-001. http://www3.epa.gov/npdes/pubs/owm0264.pdf.
---------------------------------------------------------------------------

    For the freshwater acute cadmium criterion, EPA establishes the
following critical low-flow values: 1Q10 or 1B3. Using the
hydrologically based method, the 1Q10 represents the lowest one-day
average flow event expected to occur once every ten years, on average.
Using the biologically based method, 1B3 represents the lowest one-day
average flow event expected to occur once every three years, on
average.\17\
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    \17\ See USEPA, 2014.
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    The criterion in this final rule applies at the point of discharge
unless Oregon authorizes a mixing zone. Where Oregon authorizes a
mixing zone, the criterion applies at the locations allowed by the
mixing zone (i.e., the CMC would apply at the defined boundary of the
acute mixing zone).\18\
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    \18\ See USEPA, 1991.
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    One commenter argued that EPA's proposed critical low-flow
provisions were unnecessary, asserting that Oregon already has such
provisions. Currently Oregon's implementation methods for low-flows are
in non-binding guidance. Specifying the appropriate low-flow provisions
in regulation will provide added clarity, and ensure that the acute
cadmium criterion is implemented in such a way that designated uses are
protected.

VI. Endangered Species Act

    As noted in the 2016 proposed rule, the NMFS 2012 biological
opinion concluded that the freshwater acute cadmium criterion that
Oregon adopted in 2004 would jeopardize the continued existence of
specific endangered species and their critical habitat in Oregon. The
opinion also contained a reasonable and prudent alternative (RPA) for
cadmium that would avoid the likelihood of jeopardy to endangered
species in Oregon.
    EPA has determined that the acute cadmium criterion being finalized
in this rulemaking is consistent with the RPA for acute cadmium as
contained in the NMFS 2012 biological opinion. Therefore, as finalized,
the acute cadmium criterion for Oregon is sufficiently protective of
threatened and endangered species in state waters and avoids the
likelihood of jeopardizing the continued existence of listed species or
resulting in the destruction or adverse modification of critical
habitat. EPA's RPA analysis for the acute cadmium criterion is
contained in the docket for this rule.

VII. Applicability of Criteria

    Under the CWA, Congress gave states primary responsibility for
developing and adopting WQS for their navigable waters (CWA section
303(a)-(c)). Although EPA is establishing an acute cadmium criterion
for Oregon's freshwaters to remedy EPA's 2013 disapproval of Oregon's
2004 criteria, Oregon continues to have the option to adopt and submit
to EPA an acute cadmium criterion for the state's freshwaters
consistent with CWA section 303(c) and EPA's implementing regulations
at 40 CFR part 131.
    In its April 18, 2016, proposed rule, EPA proposed that if Oregon
adopted and submitted freshwater cadmium and/or copper aquatic life
criteria after EPA's finalization of the freshwater acute cadmium
criterion and freshwater acute and chronic copper criteria, then once
EPA approved Oregon's WQS, those EPA-approved criteria in Oregon's WQS
would automatically become solely effective for CWA purposes and EPA's
promulgated criteria would no longer apply. EPA did not receive any
comments on this provision as it relates to copper and cadmium criteria
for Oregon, and this provision is moot with respect to copper since
Oregon adopted revised freshwater copper criteria (which EPA is
approving in parallel with this final acute cadmium criterion
rulemaking). However, upon further consideration of comments received
on other proposed rules where EPA proposed a similar provision, 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 expeditiously undertake such a rulemaking to withdraw the federal

acute cadmium criterion if and when Oregon adopts and EPA approves a
corresponding criterion that meets the requirements of section 303(c)
of the CWA and EPA's implementing regulations at 40 CFR part 131.

VIII. Alternative Regulatory Approaches and Implementation Mechanisms

    Oregon has considerable discretion to implement the acute cadmium
aquatic life criterion through various water quality control programs.
Among other things, EPA's regulations: (1) Specify how states and
authorized tribes establish, modify, or remove designated uses; (2)
specify the requirements for establishing criteria to protect
designated uses, including criteria modified to reflect site-specific
conditions; (3) authorize states and authorized tribes to adopt WQS
variances to provide time to achieve the applicable WQS; and (4) allow
states and authorized tribes to include compliance schedules in NPDES
permits. Each of these approaches are discussed in this section.

A. Designating Uses

    EPA's final acute cadmium criterion applies to freshwaters in
Oregon where the protection of fish and aquatic life is a designated
use (see Oregon Administrative Rules at<PHONE_NUMBER>, Table 30). The
federal regulations at 40 CFR 131.10 specify how states and authorized
tribes establish, modify or remove designated uses for their waters. If
Oregon removes designated uses such that no fish or aquatic life uses
apply to any particular water body affected by this rule and adopts the
highest attainable use,\19\ 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 acute cadmium criterion would no longer
apply to that water body. Instead, any criterion associated with the
newly designated highest attainable use would apply to that water body.
---------------------------------------------------------------------------

    \19\ Highest attainable use is the modified aquatic life,
wildlife, or recreation use that is both closest to the uses
specified in section 101(a)(2) of the Act and attainable, based on
the evaluation of the factor(s) in Sec.  131.10(g) that preclude(s)
attainment of the use and any other information or analyses that
were used to evaluate attainability. There is no required highest
attainable use where the state demonstrates the relevant use
specified in section 101(a)(2) of the Act and sub-categories of such
a use are not attainable (see 40 CFR 131.3(m)).
---------------------------------------------------------------------------

B. Site-Specific Criteria

    EPA's regulations at 40 CFR 131.11 specify 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 freshwater acute cadmium criterion that would be applied on
a watershed, area-wide, or water body-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 cadmium that protects the aquatic life-related
designated use in a particular water body. As discussed earlier, if
Oregon 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 criterion.

C. Variances

    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.
Oregon has sufficient authority to use variances when implementing the
final acute cadmium criterion, as long as such variances are adopted
consistent with 40 CFR 131.14, and submitted to EPA for review under
CWA section 303(c).

D. Compliance Schedules

    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 WQBELs 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). Oregon may use its EPA-approved regulation
authorizing the use of permit compliance schedules (see OAR 340-041-
0061), consistent with 40 CFR 131.15, to grant compliance schedules, as
appropriate, for WQBELs based on the federal acute cadmium criterion.
That state regulation is not affected by this final rule.

IX. Economic Analysis

    Although EPA's final acute cadmium criterion itself will not impose
any direct requirements on entities, this criterion may ultimately
serve as a basis for development of new or revised NPDES permit limits.
Oregon has NPDES permitting authority, and retains considerable
discretion in implementing standards. Still, to best inform the public
of the potential impacts of this rule, EPA evaluated the potential
costs associated with state implementation of EPA's final criterion.
This analysis is documented in Economic Analysis for the Final Rule:
Aquatic Life Criteria for Cadmium in Oregon, which can be found in the
record for this rulemaking.
    For the economic analysis, EPA assumed the baseline to be full
implementation of currently approved existing aquatic life criteria
(i.e., ``baseline criteria'') and then estimated the incremental
impacts for compliance with the final cadmium criterion in this rule.
For point source costs, any NPDES-permitted facility that discharges
cadmium could potentially incur compliance costs. The types of affected
facilities could include industrial facilities and publicly owned
treatment works (POTWs) discharging sanitary wastewater to surface
waters (i.e., point sources). EPA expects that dischargers would use
similar process and treatment controls to come into compliance with the
final cadmium criterion as they would to comply with Oregon's baseline
criteria.
    EPA did not estimate the potential for costs to stormwater or
nonpoint sources such as agricultural runoff. EPA recognizes that
Oregon may require controls for nonpoint sources; however, it is
difficult to model and evaluate the potential cost impacts of this rule
to those sources because they are intermittent, variable, and occur
under hydrologic or climatic conditions associated with precipitation
events. Also, baseline total maximum daily loads (TMDLs) for waters
with baseline impairment for cadmium have not yet

been developed; therefore, determining which waters would not achieve
standards based on the final aquatic life criterion after complying
with existing (baseline) regulations and policies may not be possible.

A. Identifying Affected Entities

    For identifying new criteria values for the purposes of estimating
cost incremental to costs to achieve the existing baseline criteria,
EPA developed hypothetical applications of the final cadmium criterion
using conservative estimates for hardness. The criteria that EPA
calculated for the economic analysis are likely different from and
possibly lower (more stringent) than the actual criteria applications
that Oregon would calculate using ambient data from each water body. As
described earlier in this final rule, EPA recommends that Oregon
collect sufficiently representative ambient data to calculate the most
accurate and protective cadmium criteria by site.
    Using the criteria calculated for the cost analysis, EPA identified
12 point source facilities with sufficient data for evaluation \20\
that could potentially be affected by the rule--all are major
dischargers. Major discharge facilities are typically those that
discharge more than 1 million gallons per day (mgd). Of these
potentially affected facilities, 10 are POTWs (municipals) and two are
industrial dischargers. EPA did not include facilities covered by
general permits in its analysis because none of the general permits
reviewed include specific effluent limits or monitoring requirements
for cadmium except for two industrial stormwater general permits that
include monitoring requirements for cadmium, but no effluent limits.
See the Economic Analysis for more details.
---------------------------------------------------------------------------

    \20\ EPA initially used ICIS-NPDES to identify facilities in
Oregon whose NPDES permits contain effluent limitations and/or
monitoring requirements for cadmium. There were neither sufficient
nor adequate data available to evaluate those facilities. Therefore,
EPA obtained monitoring data from the Oregon Department of
Environmental Quality. EPA excluded biosolids data, facilities with
ocean discharges (i.e., not freshwater), facilities where all
reported results were non-detect, facilities with less than three
data points, and others where there were insufficient or inadequate
data to perform the analysis. EPA obtained facility-specific
information from NPDES permits and fact sheets.
---------------------------------------------------------------------------

B. Method for Estimating Costs

    For facilities with available data, EPA evaluated existing baseline
permit conditions, reasonable potential to exceed estimates of the
aquatic life criteria based on the final rule, and potential to exceed
projected effluent limitations based on available effluent monitoring
data. There was no reasonable potential to exceed the final acute
cadmium criterion.
    If the final criterion resulted in an incremental increase in
impaired waters, resulting in the need for TMDL development, there
could also be some costs to nonpoint sources of cadmium. Using
available ambient monitoring data, EPA compared cadmium 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). EPA did not identify the potential for incremental
impairment due to the final acute cadmium criterion.

C. Results

    As discussed above, EPA determined there are no point or nonpoint
source costs associated with the acute cadmium criterion in this final
rule. None of the dischargers for which monitoring data are available
have a reasonable potential to exceed the final criterion. Therefore,
EPA estimates that point source dischargers will not incur annual costs
to comply with the final acute cadmium criterion. Additionally, based
on available monitoring data, EPA did not identify any location that
would be incrementally impaired under the final criterion. Therefore,
EPA did not attribute any cost to nonpoint sources for compliance with
the final acute cadmium criterion.

X. Statutory and Executive Order Reviews

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

    This action is a significant regulatory action that was submitted
to the Office of Management and Budget (OMB) for review. Any changes
made in response to OMB recommendations have been documented in the
docket.
    EPA prepared an analysis of the potential costs and benefits
associated with this action. This analysis, Economic Analysis for the
Final Rule: Aquatic Life Criteria for Cadmium in Oregon, is summarized
in section IX 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-
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 Oregon 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 Oregon'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 the 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 Oregon's considerable discretion in implementing these WQS,
nor will it preclude Oregon 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 does not have tribal implications as specified in
Executive Order 13175. This rule does not impose substantial direct
compliance costs on federally recognized tribal governments, nor does
it substantially affect the relationship between the federal government
and tribes, or the distribution of power and responsibilities between
the federal government and tribes. Thus, Executive Order 13175 does not
apply to this action.
    Many tribes in the Pacific Northwest hold reserved rights to take
fish for subsistence, ceremonial, religious, and commercial purposes.
EPA developed the criteria in this final rule to protect aquatic life
in Oregon from the effects of exposure to harmful levels of cadmium.
Protecting the health of fish in Oregon will, therefore, support tribal
reserved fishing rights, including treaty-reserved rights, where such
rights apply in waters under state jurisdiction.
    Consistent with the EPA Policy on Consultation and Coordination
with Indian Tribes, EPA consulted with tribal officials during the
development of this action. On November 23, 2015, EPA sent a letter to
tribal leaders in Oregon offering to consult on the proposed cadmium
criterion in this rule. On December 15, 2015, EPA held a conference
call with tribal water quality technical contacts to explain EPA's
proposed action and timeline. Formal consultation on the proposed
action was not requested by any of the tribes.

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 it does not concern an environmental health risk or safety
risk.

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)

    The human health or environmental risk addressed by this action
will not have potential disproportionately high and adverse human
health or environmental effects on minority, low-income or indigenous
populations. The criterion in this final rule will support the health
and abundance of aquatic life in Oregon, and will therefore benefit all
communities that rely on Oregon's ecosystems.

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: January 10, 2017.
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

0
2. Add Sec.  131.46 to read as follows:

Sec.  131.46  Aquatic life criterion for cadmium in Oregon.

    (a) Scope. This section promulgates an acute aquatic life criterion
for cadmium in freshwaters in Oregon.
    (b) Criterion for cadmium in Oregon. The aquatic life criterion in
Table 1 applies to all freshwaters in Oregon where fish and aquatic
life are a designated use.

     Table 1--Cadmium Aquatic Life Criterion for Oregon Freshwaters
------------------------------------------------------------------------
                                                    Criterion Maximum
             Metal                   CAS No.     Concentration (CMC) \3\
                                                       ([micro]g/L)
------------------------------------------------------------------------
Cadmium 1 2....................         7440439  [e (0.9789 x
                                                  ln(hardness) - 3.866)]
                                                  x CF
                                                 Where CF = 1.136672 -
                                                  [(ln hardness) x
                                                  (0.041838)].
------------------------------------------------------------------------
\1\ The criterion for cadmium is expressed as the dissolved metal
  concentration.
\2\ CF is the conversion factor used to convert between the total
  recoverable and dissolved forms of cadmium. The term (ln hardness) in
  the CMC and the CF equation is the natural logarithm of the ambient
  hardness in mg/L (CaCO3). The default hardness concentrations from the
  applicable ecoregion in Table 2 of paragraph (c) of this section shall
  be used to calculate cadmium criteria in the absence of sufficiently
  representative ambient hardness data.
\3\ The CMC is the highest allowable one-hour average instream
  concentration of cadmium. The CMC is not to be exceeded more than once
  every three years. The CMC is rounded to two significant figures.

    (c) Estimated Values To Calculate Cadmium Criteria. The default
inputs to calculate cadmium criteria in the absence of sufficiently
representative ambient data are shown in Table 2.

  Table 2--Hardness Defaults Within Each Level III Ecoregion in Oregon
------------------------------------------------------------------------
                                                               Hardness
                     Level III ecoregion                        (mg/L)
------------------------------------------------------------------------
1 Coast Range...............................................       34.12
3 Willamette Valley.........................................       32.39
4 Cascades..................................................       28.39

9 Eastern Cascades Slopes and Foothills.....................       36.08
10 Columbia Plateau.........................................       58.82
11 Blue Mountains...........................................       43.49
12 Snake River Plain........................................       123.5
78 Klamath Mountains........................................       40.61
80 Northern Basin and Range.................................       98.62
------------------------------------------------------------------------

    (d) Applicability. (1) The criterion in paragraph (b) of this
section applies to freshwaters in Oregon where fish and aquatic life
are a designated use, and applies concurrently with other applicable
water quality criteria.
    (2) The criterion established in this section is subject to
Oregon'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 freshwaters in Oregon where fish and aquatic
life are a designated use.
    (i) For all waters with mixing zone regulations or implementation
procedures, the criterion applies at the appropriate locations within
or at the boundary of the mixing zones and outside of the mixing zones;
otherwise the criterion applies throughout the water body including at
the end of any discharge pipe, conveyance or other discharge point
within the water body.
    (ii) The state shall not use a low flow value that is less
stringent than the values listed below for waters suitable for the
establishment of low flow return frequencies (i.e., streams and rivers)
when calculating the available dilution for the purposes of determining
the need for and establishing Water Quality-Based Effluent Limitations
in National Pollutant Discharge Elimination System permits:

------------------------------------------------------------------------
          Acute  criteria  (CMC)                     1Q10 or 1B3
------------------------------------------------------------------------
Where:
  1. 1Q10 is the lowest one-day average flow event expected to occur
   once every ten years, on average (determined hydrologically)..
  2. 1B3 is the lowest one-day average flow event expected to occur once
   every three years, on average (determined biologically)..
------------------------------------------------------------------------

[FR Doc. 2017-02283 Filed 2-2-17; 8:45 am]
BILLING CODE 6560-50-P


1 United States Prevention, Pesticides December 2004 Environmental Protection and Toxic Substances Agency ( 7508C)

Report of the Food Quality Protection Act ( FQPA) Tolerance Reassessment Progress and Risk Management Decision ( TRED) for Nicosulfuron 2 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES CERTIFIED MAIL Dear Registrant:

This is the Environmental Protection Agency's ( hereafter referred to as EPA or the Agency) " Report of the Food Quality Protection Act ( FQPA) Tolerance Reassessment Progress and Risk Management Decision for Nicosulfuron," which was approved December 2004. This document is also known as a Tolerance Reassessment Decision, or TRED. A Notice of Availability of this tolerance reassessment decision will be published shortly.

The Federal Food, Drug and Cosmetic Act ( FFDCA), as amended by FQPA, requires EPA to reassess all the tolerances for registered chemicals in effect on or before the enactment of the FQPA on August 3, 1996. In reassessing these tolerances, the Agency must consider, among other things, aggregate risks from non occupational sources of pesticide exposure, whether there is increased susceptibility to infants and children, and the cumulative effects of pesticides with a common mechanism of toxicity. Once a safety finding has been made, the tolerances are considered reassessed. Existing tolerances and exemptions associated with nicosulfuron must be reassessed in accordance with FFDCA, as amended by FQPA.

The Agency has evaluated all current registered uses of nicosulfuron and has determined that there is a reasonable certainty that no harm to any population subgroup will result from exposure to nicosulfuron when considering dietary exposure and all other non occupational sources of pesticide exposure for which there is reliable information. Therefore, no mitigation measures are needed and current tolerances at 40 CFR 180.454 for nicosulfuron are now considered reassessed under section 408( q) of the FFDCA. All tolerances were reassessed and maintained at 0.1 ppm.

Nicosulfuron is a sulfonyl urea herbicide registered for early postemergent and postemergent use on corn. It may be used alone or in formulation with other active ingredients to control annual and perennial grasses and broadleaf weeds. Application methods include band treatment, broadcast, low volume spray ( concentrate) using aircraft, or ground equipment. The maximum application rate is 0.06248 lb a. i./ acre. The highest usage of nicosulfuron is on corn and approximately 200,000 pounds are used annually. 3 Nicosulfuron is in Toxicity Category IV for acute oral, inhalation, and dermal irritation. It is Toxicity Category III for acute dermal and acute eye irritation. Nicosulfuron is not likely to be carcinogenic based on bioassays in the rat and mouse and lack of in vitro and in vivo mutagenic effects. Nicosulfuron showed no developmental or reproductive effects in rats and developmental effects in rabbits only at high doses. There were no indications of neurotoxic effects elicited by nicosulfuron in animal tests.

For acute dietary, an endpoint of concern attributable to a single dose was not identified. Acute studies showed no affect at high doses. Therefore, a risk assessment for this exposure was not performed and a toxic endpoint derived from a chronic study was considered the most appropriate for risk assessment purposes.

For the chronic dietary risk assessment, a chronic dog feeding study with a No Observable Adverse Effect Level ( NOAEL) of 125 mg/ kg/ day and a Lowest Observed Adverse Effect Dose ( LOAEL) of 500 mg/ kg/ day was used. All population subgroups' Chronic Population Adjusted Dose (% cPAD) are less than 1% which is below the Agency's Level of Concern ( LOC).

In addition, for chronic aggregate exposure ( food + water), nicosulfuron dietary exposure and risk is below EPA's level of concern. The level of refinement of the analyses is Tier 1 or tolerance level without any percent crop treated information. EPA's LOC for the aggregate is not exceeded for all population subgroups including the general U. S. population for the chronic analyses. The population subgroup, children ages 3 5, utilizes the highest percentage of the cPAD and constitutes less than 1%.

There are no residential uses that might contribute to aggregate risks, and occupational exposure is not assessed in this TRED. There are no unfulfilled data requirements for nicosulfuron.

The nature of the residue in plants and livestock is adequately understood based on metabolism studies with corn and goats. The residue of concern for both risk assessment and tolerance enforcement purposes is nicosulfuron per se. Seven tolerances for corn scenarios ( all set at 0.1 ppm) are established under 40 CFR § 180.454 for residues of nicosulfuron [ 3 pyridinecarboxamide, 2 (((( 4,6 dimethoxypyrimidin 2 yl) aminocarbonyl) aminosulfonyl))  N, N dimethyl]. There are no tolerances established for nicosulfuron residues in livestock tissues, milk or eggs as the Agency has concluded that there is no reasonable expectation of finite residues ( 40 CFR § 180.6( a)( 3)) of nicosulfuron in livestock commodities based on the current registered uses in or on livestock feed commodities that might result in nicosulfuron residues. Therefore, the seven existing tolerances for nicosulfuron are considered reassessed under Section 408( q) of the FFDCA.

FQPA requires that EPA consider " available information" concerning the cumulative effects of a particular pesticide's residues and " other substances that have a common mechanism of toxicity." The Agency considers other substances because low level exposures to multiple chemical substances that cause a common toxic effect by a common mechanism could lead to the same adverse health 4 effect, as would a higher level of exposure to any of the other substances individually.

Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to nicosulfuron and any other substances and nicosulfuron does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that nicosulfuron has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at http:// www. epa. gov/ pesticides/ cumulative/.

Based on currently available data, nicosulfuron does not appear to be an endocrine disruptor. However, when the appropriate screening and/ or testing protocols being considered under the Agency's Endocrine Disruptor Screening Program have been developed, nicosulfuron may be subjected to additional screening and/ or testing to better characterize effects related to endocrine disruption.

This document summarizes the Agency's decision on the tolerance reassessment for nicosulfuron. Please contact Meghan French of my staff with any questions regarding this decision. She may be reached by phone at ( 703) 308 8004 or by e mail at french. meghan@ epa. gov.

Sincerely,

Debra Edwards, Ph. D. Director Special Review and Reregistration Division Enclosures: Nicosulfuron Risk Assessment Document 5 6