[Federal Register Volume 87, Number 30 (Monday, February 14, 2022)]
[Rules and Regulations]
[Pages 8150-8152]
[FR Doc No: 2022-03030]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0961; Project Identifier MCAI-2021-00924-A;
Amendment 39-21935; AD 2022-03-18]
RIN 2120-AA64

Airworthiness Directives; British Aerospace (Operations) Limited
and British Aerospace Regional Aircraft Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain British Aerospace (Operations) Limited and British Aerospace
Regional Aircraft Model Jetstream Series 200, Jetstream Model 3101, and
Jetstream Model 3201 airplanes. This AD results from mandatory
continuing airworthiness information (MCAI) originated by an aviation
authority of another country to identify and correct an unsafe
condition on an aviation product. The MCAI identifies the unsafe
condition as a bent control rod within the gust lock system, which may
enable both power levers to be pushed into the flight range with the
gust lock lever fully engaged. This AD requires replacing the push rod
assembly with a modified push rod assembly. The FAA is issuing this AD
to address the unsafe condition on these products.

DATES: This AD is effective March 21, 2022.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of March 21,
2022.

ADDRESSES: For service information identified in this final rule,
contact BAE Systems (Operations) Ltd., Customer Information Department,
Prestwick International Airport, Ayrshire, KA9 2RW, Scotland, United
Kingdom; phone: +44 3300 488727; fax: +44 1292 675704; email:
[email protected]; website: https://www.baesystems.com/Businesses/RegionalAircraft/. You may view this service information at
the FAA, Airworthiness Products Section, Operational Safety Branch, 901
Locust, Kansas City, MO 64106. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>. It is also available at
https://www.regulations.gov by searching for and locating Docket No.
FAA-2021-0961.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2021-0961; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this final rule, the
MCAI, any comments received, and other information. The address for
Docket Operations is U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Doug Rudolph, Aviation Safety
Engineer, General Aviation & Rotorcraft Section, International
Validation Branch, FAA, 901 Locust, Room 301, Kansas City, MO 64106;
phone:<PHONE_NUMBER>; email: [email protected].

SUPPLEMENTARY INFORMATION:

Background

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to certain serial-numbered
British Aerospace (Operations) Limited and British Aerospace Regional
Aircraft Model Jetstream Series 200, Jetstream Model 3101, and
Jetstream Model 3201 airplanes. The NPRM published in the Federal
Register on November 12, 2021 (86 FR 62742). The NPRM was prompted by
MCAI originated by the Civil Aviation Authority (CAA), which is the
aviation authority for the United Kingdom. CAA has issued CAA AD G-
2021-0005, dated August 3, 2021 (referred to after this as ``the
MCAI''), to address an unsafe condition on certain serial-numbered BAE
Systems (Operations) Ltd. Model Jetstream Series 3100 and Series 3200
airplanes. The MCAI states:

    On 8 October 2019, a Jetstream Series 3200 aircraft aborted
take-off at a speed of approximately 130 kt and veered off the
runway. The investigation into the serious incident concluded the
take-off was initiated with an engaged Gust Lock Mechanism,
resulting in a temporary loss of aircraft control. Damage was
identified in the Gust Lock mechanism, which allowed both power
levers to be moved beyond flight idle with the gust locks engaged.
    The serious incident investigation determined that a bent
control rod within the gust lock system made it possible to move
both power levers simultaneously to the max position, even though
the gust locks were still engaged.
    The gust-lock system is designed to lock and prevent damage to
the control surfaces when the aircraft is parked during gusting wind
conditions. The system contains a mechanical baulk which prevents
both power levers from being moved beyond the flight idle position
when the gust locks are engaged.
    Three previous occurrences in which a bent control rod enabled
both power levers to be moved simultaneously beyond the flight idle
position while the gust lock system was engaged have been identified
by the Type Certificate Holder. Service Bulletin 27-JM 5350 was
first published in 1992 to introduce a stronger control rod.
    This condition, if not prevented, could lead to partial or total
loss of aircraft control. To address this potential unsafe
condition, this [CAA] AD mandates the installation of a modified
push rod assembly.
    BAE Systems operating manuals contain pre-flight checks that are
designed to ensure the gust locks are not engaged during take-off.

    You may examine the MCAI in the AD docket at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-
0961.
    In the NPRM, the FAA proposed to require replacing the push rod
assembly with a modified push rod assembly. The FAA is issuing this AD
to address the unsafe condition on this product.

Discussion of Final Airworthiness Directive

Comments

    The FAA received no comments on the NPRM or on the determination of
the costs.

Conclusion

    This product has been approved by the aviation authority of another
country and is approved for operation in the United States. Pursuant to
the FAA's bilateral agreement with this State of Design Authority, it
has notified the FAA of the unsafe condition described in the MCAI and
service information referenced above. The FAA reviewed the relevant
data and determined that air safety and the public interest require
adopting this AD as proposed. Accordingly, the FAA is issuing this AD
to address the unsafe condition on these products. This AD is adopted
as proposed in the NPRM.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Jetstream Series 3100/3200 Service Bulletin 27-JM
5350, Revision 1, dated May 6, 1994. This service information specifies
procedures for replacing push rod assembly part number (P/N) 137201E419
with push rod assembly P/N 137201E429. This service information is
reasonably available because the interested parties have access to it
through their normal course of business or by the means identified in
the ADDRESSES section.

Differences Between This AD and the MCAI

    The MCAI does not apply to the Model Jetstream Series 200, whereas
this AD includes the Model Jetstream Series 200 because this model has
an FAA type certificate and shares a similar type design in the
affected area. The MCAI and service information apply to Model
Jetstream Series 3100 and Jetstream Series 3200 airplanes, which are
identified on the FAA type certificates as Jetstream Model 3101 and
Jetstream Model 3201 airplanes, respectively.

Costs of Compliance

    The FAA estimates that this AD affects 43 airplanes of U.S.
registry.
    The FAA estimates that it would take about 6 work-hours per
airplane to replace the push rod assembly. The average labor rate is
$85 per work-hour. Required parts would cost about $300 per airplane.
    Based on these figures, the FAA estimates the cost on U.S.
operators to be $34,830 or $810 per airplane.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect 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.
    For the reasons discussed above, I certify that this AD:

    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13   [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive:

2022-03-18 British Aerospace (Operations) Limited and British
Aerospace Regional Aircraft: Amendment 39-21935; Docket No. FAA-
2021-0961; Project Identifier MCAI-2021-00924-A.

(a) Effective Date

    This airworthiness directive (AD) is effective March 21, 2022.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to British Aerospace (Operations) Limited and
British Aerospace Regional Aircraft Model Jetstream Series 200,
Jetstream Model 3101, and Jetstream Model 3201 airplanes, serial
numbers 1 through 927 and 929 through 936 inclusive, certificated in
any category.

(d) Subject

    Joint Aircraft System Component (JASC) Code 2770, Gust Lock/
Damper System.

(e) Unsafe Condition

    This AD was prompted by mandatory continuing airworthiness
information (MCAI) originated by an aviation authority of another
country to identify and correct an unsafe condition on an aviation
product. The MCAI describes the unsafe condition as a bent control
rod within the gust lock system, which may enable both power levers
to be pushed into the flight range with the gust lock lever fully
engaged. The FAA is issuing this AD to detect and correct bent push
rod assemblies of the power lever baulk system. The unsafe
condition, if not addressed, could result in loss of airplane
control.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Action

    Within 2 years after the effective date of this AD, replace push
rod assembly part number (P/N) 137201E419 with push rod assembly P/N
137201E429 by following the Accomplishment Instructions, sections
2.A. through 2.C. in Jetstream Series 3100/3200 Service Bulletin 27-
JM 5350, Revision 1, dated May 6, 1994.

(h) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, International Validation Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the manager of the certification office, send it to the
attention of the person identified in paragraph (i)(1) of this AD
and email to: [email protected].
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(i) Related Information

    (1) For more information about this AD, contact Doug Rudolph,
Aviation Safety Engineer, General Aviation & Rotorcraft Section,
International Validation Branch, FAA, 901 Locust, Room 301, Kansas
City, MO 64106; phone:<PHONE_NUMBER>; email: [email protected].
    (2) Refer to Civil Aviation Authority (CAA) AD G-2021-0005,
dated August 3, 2021, for more information. You may examine the CAA
AD at https://www.regulations.gov by searching for and locating
Docket No. FAA-2021-0961.

(j) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Jetstream Series 3100/3200 Service Bulletin 27-JM 5350,
Revision 1, dated May 6, 1994.
    (ii) [Reserved]
    (3) For service information identified in this AD, contact BAE
Systems (Operations) Ltd., Customer Information Department,
Prestwick International Airport, Ayrshire, KA9 2RW, Scotland, United
Kingdom; phone: +44 3300 488727; fax: +44 1292 675704; email:
[email protected]; website: https://www.baesystems.com/Businesses/RegionalAircraft/.
    (4) You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 901
Locust, Kansas City, MO 64106. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, email: [email protected], or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on January 26, 2022.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2022-03030 Filed 2-11-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: October 5, 2010 (Volume 75, Number 192)]
[Notices]
[Page 61495-61497]
[DOCID:fr05oc10-109]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0161]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Export of Food and
Drug Administration Regulated Products: Export Certificates

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by
November 4, 2010.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0498.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-

400B, Rockville, MD 20850,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Export of Food and Drug Administration Regulated Products: Export
Certificates--(OMB Control Number 0910-0498)--Extension

    In April 1996, a law entitled ``The FDA Export Reform & Enhancement
Act of 1996'' (FDAERA) amended sections 801(e) and 802 of the act (21
U.S.C. 381(e) and 382). It was designed to ease restrictions on
exportation of unapproved pharmaceuticals, biologics, and devices
regulated by FDA. Section 801(e)(4) of the FDAERA provides that persons
exporting certain FDA-regulated products may request FDA to certify
that the products meet the requirements of 801(e) and 802 or other
requirements of the act. This section of the law requires FDA to issue
certification within 20 days of receipt of the request and to charge
firms up to $175 for the certifications.
    This new section of the act authorizes FDA to issue export
certificates for regulated pharmaceuticals, biologics, and devices that
are legally marketed in the United States, as well as for these same
products that are not legally marketed but are acceptable to the
importing country, as specified in sections 801(e) and 802 of the act.
FDA has developed five types of certificates that satisfy the
requirements of section 801(e)(4)(B) of the act: (1) Certificates to
Foreign Governments, (2) Certificates of Exportability, (3)
Certificates of a Pharmaceutical Product, (4) Non-Clinical Research Use
Only Certificates, and (5) Certificates of Free Sale. Table 1 of this
document lists the different certificates and details their use:

------------------------------------------------------------------------
          Type of Certificate                          Use
------------------------------------------------------------------------
``Supplementary Information Certificate  For the export of products
 to Foreign Government Requests''         legally marketed in the United
``Exporter's Certification Statement      States
 Certificate to Foreign Government''
``Exporter's Certification Statement
 Certificate to Foreign Government (For
 Human Tissue Intended for
 Transplantation)''
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                                         For the export of products not
``Supplementary Information Certificate   approved for marketing in the
 of Exportability Requests''              United States (unapproved
``Exporter's Certification Statement      products) that meet the
 Certificate of Exportability''           requirements of sections
                                          801(e) or 802 of the act
------------------------------------------------------------------------
                                         Conforms to the format
``Supplementary Information Certificate   established by the World
 of a Pharmaceutical Product''            Health Organization and is
``Exporter's Certification Statement      intended for use by the
 Certificate of a Pharmaceutical          importing country when the
 Product''                                product in question is under
                                          consideration for a product
                                          license that will authorize
                                          its importation and sale or
                                          for renewal, extension,
                                          amending, or reviewing a
                                          license
------------------------------------------------------------------------
                                         For the export of a non-
``Supplementary Information Non-          clinical research use only
 Clinical Research Use Only               product, material, or
 Certificate''                            component that is not intended
``Exporter's Certification Statement      for human use which may be
 (Non-Clinical Research Use Only)''       marketed in, and legally
                                          exported from the United
                                          States under the act
------------------------------------------------------------------------
Certificate of Free Sale                 For food, cosmetic products,
                                          and dietary supplements that
                                          may be legally marketed in the
                                          United States
------------------------------------------------------------------------

    FDA will continue to rely on self-certification by manufacturers
for the first three types of certificates listed in table 1 of this
document. Manufacturers are requested to self-certify that they are in
compliance with all applicable requirements of the act, not only at the
time that they submit their request to the appropriate center, but also
at the time that they submit the certification to the foreign
government.
    The appropriate FDA centers will review product information
submitted by firms in support of their certificate and any suspected
case of fraud will be referred to FDA's Office of Criminal
Investigations for followup. Making or submitting to FDA false
statements on any documents may constitute violations of 18 U.S.C.
1001, with penalties including up to $250,000 in fines and up to 5
years imprisonment.
    In the Federal Register of March 31, 2010 (75 FR 16137), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                                                   Table 1--Total Estimated Annual Reporting Burden\1\
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                                                              No. of         Annual Frequency       Total Annual        Hours per
                      FDA Center                           Respondents         per Response          Responses           Response         Total Hours
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Center for Biologics Evaluation and Research                        2,114                     1              2,114                  1              2,114
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Center for Drug Evaluation and Research                             5,251                     1              5,251                  2             10,502
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Center for Devices and Radiological Health                          6,463                     1              6,463                  2             12,926
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Center for Veterinary Medicine                                        855                     1                855                  1                855
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Center for Food Safety and Applied Nutrition (Three different product categories)
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                                                                      386                     2                772                1.5              1,158
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                                                                      247                    47             11,609                  2             23,218
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                                                                      337                     1                337                0.5                169
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Total                                                              15,653  ....................             27,401  .................             50,942
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: September 30, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-25009 Filed 10-4-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register Volume 82, Number 205 (Wednesday, October 25, 2017)]
[Notices]
[Pages 49428-49429]
[FR Doc No: 2017-23115]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-81900; File No. SR-OPRA-2017-02]

Options Price Reporting Authority; Notice of Filing and Immediate
Effectiveness of Proposed Amendment To Modify the OPRA Fee Schedule To
Eliminate the Enterprise Rate Non-Professional Subscriber Fee and Amend
the Non-Professional Subscriber Fee

October 19, 2017.
    Pursuant to Section 11A of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 608 thereunder,\2\ notice is hereby given that
on September 27, 2017, the Options Price Reporting Authority (``OPRA'')
submitted to the Securities and Exchange Commission (``Commission'') an
amendment to the Plan for Reporting of Consolidated Options Last Sale
Reports and Quotation Information (``OPRA Plan'').\3\ The OPRA Plan
amendment would implement changes to the Non-Professional Subscriber
Fee and Eliminate the Enterprise Rate Non-Professional Subscriber Fee
effective January 1, 2018. The Commission is publishing this notice to
provide interested persons an opportunity to submit written comments on
the OPRA Plan amendment.
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    \1\ 15 U.S.C. 78k-1.
    \2\ 17 CFR 242.608.
    \3\ The OPRA Plan is a national market system plan approved by
the Commission pursuant to Section 11A of the Act and Rule 608
thereunder. See Securities Exchange Act Release No. 17638 (March 18,
1981), 22 S.E.C. Docket 484 (March 31, 1981). The full text of the
OPRA Plan and a list of its fifteen participants are available at
http://www.opradata.com. The OPRA Plan provides for the collection
and dissemination of last sale and quotation information on options
that are traded on the participant exchanges.
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I. Description and Purpose of the Plan Amendment

(a) Fee Schedule Amendments

    The purpose of the amendment is to eliminate OPRA's Enterprise Rate
Nonprofessional Subscriber Fee (``Enterprise Rate Nonpro Fee'') and to
revise its Nonprofessional Subscriber Fee so that, instead of being a
flat fee of $1.25 per month per Nonprofessional Subscriber, the
Nonprofessional Subscriber Fee will have five tiers, with the tier for
a Vendor's first 75,000 Nonprofessional Subscribers subject to the
current rate of $1.25 per month and each of the successive higher tiers
subject to a lower rate.
    OPRA's Fee Schedule provides that a Vendor \4\ may determine the
fee that it pays with respect to its distribution of current OPRA data
to a Nonprofessional Subscriber \5\ in one of two ways: Either the
Vendor may pay OPRA's monthly Nonprofessional Subscriber Fee (currently
$1.25/month), or the Vendor may count the Nonprofessional Subscriber's
queries for OPRA data and pay Usage-based Vendor Fees based on the
actual usage of OPRA data by the Nonprofessional Subscriber, subject to
a cap that OPRA has always set at the amount of the Nonprofessional
Subscriber Fee.\6\
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    \4\ OPRA defines a ``Vendor,'' in general, as an entity that
receives OPRA data and redistributes it externally, that is, to
persons other than its own employees and employees of its wholly-
owned subsidiaries.
    \5\ OPRA defines a ``Subscriber,'' in general, as an entity or
person that receives OPRA data but does not redistribute it to third
parties, and defines a ``Nonprofessional Subscriber'' as a
Subscriber who is a ``Nonprofessional.'' OPRA's definition of the
term ``Nonprofessional'' is stated in its forms of ``Electronic
Subscriber Agreement'' and ``Hardcopy Subscriber Agreement.'' These
forms are available on OPRA's Web site, www.opradata.com. With a
limited exception for certain personal trusts that is described in
the Electronic Subscriber Agreement and Hardcopy Subscriber
Agreement, a Nonprofessional Subscriber must be a natural person.
    \6\ Many Vendors prefer to pay the flat Nonprofessional
Subscriber Fee, even though their aggregate fees on the basis of
Usage-based Vendor Fees might be lower and could not be greater, due
to the administrative simplicity of doing so and the fact that the
cost on a per Subscriber basis of doing so is very small.
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    OPRA introduced the Enterprise Rate Nonpro Fee in 2012.\7\ The
purpose of the Fee was to limit the maximum aggregate amount of
Nonprofessional Subscriber Fees and Usage-based Vendor Fees with
respect to Nonprofessional Subscribers that any Vendor would be
required to pay with respect to its Nonprofessional Subscribers. OPRA's
Enterprise Rate Nonpro Fee was established at $375,000 per month. When
the Enterprise Rate Nonpro Fee was introduced, the fee provided a
benefit to one OPRA Vendor, but OPRA's expectation was that the fee
would provide an incentive for other Vendors to increase the number of
Nonprofessional Subscribers to whom they distribute OPRA data.
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    \7\ See Securities Exchange Act Release No. 66564 (March 9,
2012) (File No. SR-OPRA-2012-02).
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    OPRA's expectation for the Enterprise Rate Nonpro Fee has not been
fulfilled. The fee continues to provide a benefit to only one OPRA
Vendor, and it now appears to OPRA that this is likely to remain the
case indefinitely.
    Accordingly, OPRA is proposing to eliminate the Enterprise Rate
Nonpro Fee and, at the same time, revise OPRA's Nonprofessional
Subscriber Fee so that the fee has five tiers: $1.25/month for a
Vendor's first 75,000 Nonprofessional Subscribers, $1.15/month for the
Vendor's next 75,000 Nonprofessional Subscribers, $1.00/month for the
Vendor's next 100,000 Nonprofessional Subscribers, $0.75/month for the
Vendor's next 250,000 Nonprofessional Subscribers, and $0.60/month for
the Vendor's Nonprofessional Subscribers in excess of 500,000
Nonprofessional Subscribers.\8\
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    \8\ For example, a hypothetical Vendor that reports 310,000
Nonprofessional Subscribers in a month would pay total
Nonprofessional Subscriber Fees of $337,500 for the month: The sum
of (75,000 x $1.25) + (75,000 x $1.15) + (150,000 x $1.00) + (10,000
x $0.75).
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    If all Vendors were to continue to distribute OPRA data to
Nonprofessional Subscribers at their current rates, these changes would
result in an increase in OPRA's annual revenues of approximately
$135,000. However, OPRA anticipates that, in fact,

in the short term the Vendor that has had the benefit of the Enterprise
Rate Nonpro Fee may reduce its distribution of OPRA data to
Nonprofessional Subscribers and that these changes may therefore result
in a decrease in OPRA's annual revenues. In the longer term, OPRA
anticipates that it is possible that the tiered Nonprofessional
Subscriber fees may accomplish OPRA's original expectation for the
Enterprise Rate Nonpro Fee by providing an incentive for Vendors to
increase the number of Nonprofessional Subscribers to whom they
distribute OPRA data in view of the reduced fees in the higher tiers.
    The text of the amendment to the OPRA Plan is available at OPRA,
the Commission's Public Reference Room, the OPRA Web site at http://opradata.com, and on the Commission's Web site at www.sec.gov.

(b) Implementation of the OPRA Plan Amendment

    Pursuant to paragraph (b)(3)(i) of Rule 608 of Regulation NMS under
the Act, OPRA designated this amendment as establishing or changing
fees or other charges collected on behalf of all of the OPRA
participant exchanges in connection with access to or use of OPRA
facilities. In order to give persons subject to these fees advance
notice of the changes, OPRA proposes that they go into effect on
January 1, 2018.

(c) Phases of Development and Implementation

    Not applicable.

(d) Impact on Competition

    OPRA believes that the proposed amendment will impose no burdens on
competition that are not justified in light of the purposes of the Act.

(e) Written Understandings or Agreements Among the Plan Participants

    Not applicable.

(f) Approval of the Proposed Amendment

    OPRA represents that the proposed amendments to the OPRA Fee
Schedule were approved in accordance with the provisions of the OPRA
Plan.
    The Commission may summarily abrogate the amendment within sixty
days of its filing and require refiling and approval of the amendment
by Commission order pursuant to Rule 608(b)(2) under the Act \9\ if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or the
maintenance of fair and orderly markets, to remove impediments to, and
perfect the mechanisms of, a national market system, or otherwise in
furtherance of the purposes of the Act.\10\
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    \9\ See 17 CFR 242.608(b)(2).
    \10\ See 17 CFR 242.608(b)(3)(iii).
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II. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File No. SR-OPRA-2017-02 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-OPRA-2017-02. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the OPRA Plan amendment that are
filed with the Commission, and all written communications relating to
the OPRA Plan amendment between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at the principal office of OPRA. All
comments received will be posted without change. Persons submitting
comments are cautioned that we do not redact or edit personal
identifying information from comment submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-OPRA-2017-02 and should be
submitted on or before November 15, 2017.

    By the Commission.
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-23115 Filed 10-24-17; 8:45 am]
 BILLING CODE 8011-01-P


                                                                        6560-50
                        ENVIRONMENTAL PROTECTION AGENCY
                              40 C.F.R. Part 261
                    [EPA-R10-RCRA-2018-0538; SW-FRL-     ]

                      Hazardous Waste Management System;
                            Proposed Exclusion for
                    Identifying and Listing Hazardous Waste

AGENCY:  Environmental Protection Agency (EPA).
ACTION:  Proposed rule and request for comment.
SUMMARY:  The EPA (also, "the Agency" or "we" in this preamble) is proposing to grant a petition submitted by Sandvik Special Metals (Sandvik), in Kennewick, Washington to exclude (or "delist") up to 1,500 cubic yards of F006 wastewater treatment sludge per year from the list of federal hazardous wastes.
      The Agency is proposing to grant the petition based on an evaluation of waste-specific information provided by Sandvik.  This proposed decision, if finalized, conditionally excludes the petitioned waste from the requirements of hazardous waste regulations under the Resource Conservation and Recovery Act.
      We conclude that Sandvik's petitioned waste is nonhazardous with respect to the original federal listing criteria and that there are no other factors (including additional constituents) other than those for which the waste was listed that would warrant retaining the waste as a hazardous waste.  Subject to state-only requirements within the state of Washington, or federally-authorized or state-only requirements in other states where the subject wastes may be disposed of, Sandvik's petitioned waste may be disposed of in a Subtitle D landfill which is permitted, licensed, or registered by a State to manage industrial solid waste.

DATES: Comments must be received on or before [Insert date 30 days after publication in the FEDERAL REGISTER].  Requests for an informal hearing must reach EPA by [Insert date 15 days after publication in the FEDERAL REGISTER].
ADDRESSES: Submit your comments, identified by Docket ID No. [To be added] by one of the following methods:
	:: www.regulations.gov: Follow the on-line instructions for submitting comments.
	:: Mail: to Dr. David Bartus, Office of Air and Waste, EPA Region 10, 1200 6[th] Avenue, Suite 155, M/S-150, Seattle, Washington, 98101.
	:: Hand Delivery: to Dr. David Bartus, Office of Air and Waste, EPA Region 10, 1200 6[th] Avenue, Suite 155, M/S-150, Seattle, Washington, 98101.  Such deliveries are only accepted during normal hours of operation.  Please contact David Bartus at<PHONE_NUMBER>.
Instructions:  Direct your comments to Docket ID No. [To be added].  EPA's policy is that all comments received will be included in the public docket without change and may be made available online at www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.  Do not submit information that you consider to be CBI or otherwise protected through www.regulations.gov or e-mail.  The www.regulations.gov website is an "anonymous access" system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment.  If you send an e-mail comment directly to EPA without going through www.regulations.gov your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet.  If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any physical media you submit.  If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses.
      Any person may request an informal hearing on this proposed decision by filing a request with Timothy Hamlin, Director, Office of Air and Waste, EPA Region 10, 1200 6[th] Ave., Suite 155, M/S-150, Seattle, Washington, 98101.  The request must contain the information prescribed in 40 Code of Federal Regulations (C.F.R.) § 260.20(d).
Docket: All documents in the docket are listed in the www.regulations.gov index.  Although listed in the index, some information may not be publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy form.  Publicly available docket materials are available either electronically through www.regulations.gov or in hard copy at the RCRA Records Center, 16th floor, U.S. EPA Region10, 1200 6[th] Ave., Suite 155, Seattle, Washington, 98101.  This facility is open from 8:30 am to 4:00 pm, Monday through Friday, excluding legal holidays. We recommend you telephone David Bartus at<PHONE_NUMBER> before visiting the Region 10 office.  The public may copy material from the regulatory docket at 15 cents per page.

FOR FURTHER INFORMATION, CONTACT:	Dr. David Bartus, EPA Region 10, 1200 6[th] Ave., Suite 155, M/S-150, Seattle, Washington, 98070; telephone number:<PHONE_NUMBER>; fax number<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
The information in this section is organized as follows:
I.	Overview Information
II.	Background
      A.	What is a listed waste?
      B.	What is a delisting petition?
      C.	What factors must EPA consider in deciding whether to grant a delisting petition?
III.	EPA's Evaluation of the Waste Information and Data
      A.	What waste did Sandvik petition EPA to delist?
      B.	How does Sandvik generate the waste?
      C.	How did Sandvik sample and analyze the waste?
      D.	What were the results of Sandvik's analysis of the waste?
      E.	How did EPA evaluate the risk of delisting this waste?
      F.	What did EPA conclude about Sandvik's waste?
IV.	Conditions for Exclusion
      A.	When would EPA finalize the proposed delisting exclusion?
      B.	How will Sandvik manage the waste if it is delisted?
      C.	What are the maximum allowable concentrations of hazardous constituents in the waste?
      D.	How frequently must Sandvik test the waste?
      E.	What data must Sandvik submit?
      F.	What happens if Sandvik's waste fails to meet the conditions of the exclusion?
      G.	What must Sandvik do if the process changes?
V.	How would this action affect states?
VI.	Statutory and Executive Order Reviews

I.	Overview Information
      The EPA is proposing to grant the petition submitted by Sandvik Special Metals (Sandvik) located in Kennewick, Washington to exclude or delist an annual volume of up to 1,500 cubic yards of F006 wastewater treatment sludge from the lists of hazardous waste set forth in 40 Code of Federal Regulations (C.F.R.) § 261.31. Sandvik claims that the petitioned waste does not meet the criteria for which the EPA listed it, and that there are no additional constituents or factors which could cause the waste to be hazardous.
      Based on our review described in section III, we agree with the petitioner that the waste is nonhazardous.  We reviewed the description of the process which generates the waste and the analytical data submitted by Sandvik.  We believe that the petitioned waste does not meet the criteria for which the waste was listed, and that there are no other factors which might cause the waste to be hazardous.
II.	Background
A.	What is a listed waste?
      The EPA published an amended list of hazardous wastes from nonspecific and specific sources on January 16, 1981, as part of its final and interim final regulations implementing § 3001 of Resource Conservation and Recovery Act (RCRA).  The EPA has amended this list several times and published it in 40 C.F.R. §§ 261.31 and 261.32.

      We list these wastes as hazardous because: (1) they typically and frequently exhibit one or more of the characteristics of hazardous wastes identified in subpart C of part 261 (that is, ignitability, corrosivity, reactivity, and toxicity) or (2) they meet the criteria for listing contained in § 261.11(a)(2) or (3).
B.	What is a delisting petition?
      Individual waste streams may vary depending on raw materials, industrial processes, and other factors.  Thus, while a waste described in the regulations generally is hazardous, a specific waste from an individual facility meeting the listing description may not be hazardous.
      A procedure to exclude or delist a waste is provided in 40 C.F.R. §§ 260.20 and 260.22 which allows a person or a facility to submit a petition to the EPA or to an authorized state demonstrating that a specific waste from a particular generating facility is not hazardous.

       In a delisting petition, the petitioner must show that a waste does not meet any of the criteria for listed wastes in 40 C.F.R. § 261.11 and that the waste does not exhibit any of the hazardous waste characteristics of ignitability, reactivity, corrosivity, or toxicity.  The petitioner must present sufficient information for us to decide whether any factors in addition to those for which the waste was listed warrant retaining it as a hazardous waste. (See § 260.22, 42 U.S.C. § 6921(f) and the background documents for the listed wastes.)
      If a delisting petition is granted, the generator remains obligated under RCRA to confirm that the waste remains nonhazardous according to the conditions of the delisting.
C.	What factors must EPA consider in deciding whether to grant a delisting petition?
      In reviewing this petition, we considered the original listing criteria and the additional factors required by the Hazardous and Solid Waste Amendments of 1984 (HSWA).  See § 222 of HSWA, 42 U.S.C. § 6921(f), and 40 C.F.R. § 260.22(d)(2)-(4).  We evaluated the petitioned waste against the listing criteria and factors cited in § 261.11(a)(2) and (3).
      Besides considering the criteria in 40 C.F.R. § 260.22(a), § 261.11(a)(2) and (3), 42 U.S.C. § 6921(f), and in the background documents for the listed wastes, EPA must consider any factors (including additional constituents) other than those for which we listed the waste if these additional factors could cause the waste to be hazardous.

      Our proposed decision to grant the petition to delist the waste from Sandvik's Kennewick, Washington facility is based on our evaluation of the waste for factors or criteria which could cause the waste to be hazardous. These factors included: (1) whether the waste is considered acutely toxic; (2) the toxicity of the constituents; (3) the concentration of the constituents in the waste; (4) the tendency of the constituents to migrate and to bioaccumulate; (5) the persistence in the environment of any constituents once released from the waste; (6) plausible and specific types of management of the petitioned waste; (7) the quantity of waste produced; and (8) waste variability.
      EPA must also consider as hazardous wastes mixtures containing listed hazardous wastes and wastes derived from treating, storing, or disposing of listed hazardous waste.  See 40 C.F.R. §§ 261.3(a)(2)(iv) and (c)(2)(i), called the "mixture" and "derived-from" rules, respectively.  Mixture and derived-from wastes are also eligible for exclusion but remain hazardous until excluded.
III.	EPA's Evaluation of the Waste Information and Data
A.	What waste did Sandvik petition EPA to delist?

      On April 27, 2018, Sandvik petitioned EPA to exclude an annual volume of up to 1,500 cubic yards of F006 wastewater treatment sludges generated at its facility located in Kennewick, Washington from the list of hazardous wastes contained in 40 C.F.R. § 261.31.  F006 is defined in § 261.31 as "Wastewater treatment sludges from electroplating operations . . ."   Sandvik claims that the petitioned waste does not meet the criteria for which F006 was listed (i.e., cadmium, hexavalent chromium, nickel and complexed cyanide) and that there are no other factors which would cause the waste to be hazardous.
B.	How does Sandvik generate the waste?

      Sandvik Special Metals fabricates specialty titanium and zirconium tubing for the aeronautical, medical and nuclear industries. The filter cake waste material that is the subject of this delisting action is the combined end waste from the wastewater treatment facility (WWTF) that manages F006 chemical etching wastes, and a separate coolant process waste stream associated with Sandvik's manufacturing process. A detailed description of the processes which contribute to the filter cake, including the wastewater treatment and the manufacturing processes, associated alloys and process materials, is provided below.
      Titanium and zirconium alloys are the main raw materials for the manufacturing process, with titanium being used for most products and zirconium being used only on special orders for the nuclear industry. In recent years, zirconium accounted for less than one percent of the total production  -  however, zirconium has accounted for up to 10-20% of the production volume historically. The manufacturing processes meet strict industry standards for Sandvik customers and are consistent at the Kennewick facility.
      The standard tube making process for titanium (Ti) and zirconium (Zr) alloyed tubing includes three main steps. See Figure 1 in Sandvik's delisting petition. The alloys used in the process arrive at the Kennewick facility in the form of large diameter rough tubing (either extrusions or Trex [which is an extrusion that has been reduced once]) from one of two suppliers, Sandvik SZ in Sweden or ATI in Oregon. In the first tube-making process, the extrusions or Trex go through multiple cold pilger steps to reduce the diameter size of the tubing into seamless hollow metal tubing. The cold pilgering process uses roll dies (presses) and a tapered mandrel (the rod that supports the inside of the tube during formation) to reduce the size of the tubing cross section. A fatty acid coolant/lubricant is used to manage heat generation during the process. The number of cold pilgering steps is dependent on the available starting materials and final tube size. After each cold pilger step, the interior of the tube is cleaned in a hot alkaline solution to remove the fatty acid coolant/lubricant used in the forming process, resulting in the generation of an alkaline rinsing solution that is discharged to the WWTF and a small amount of used fatty acid coolant/lubricant, which is pumped to an underground storage tank and then batch transferred to the WWTF.
      The second step in the tube forming process is a high temperature anneal step
performed to relieve stress on the metal that can make it brittle after cold forming.
Annealing also improves the homogeneity of the metal and can improve the
ductile and toughness properties. No waste is generated during the annealing
process.
      During the third step, after annealing, the hollows, or final tubes, are rotary straightened and
 cleaned in the hot alkaline solution again to remove the straightening lubrication.
The cleaned hollows are open dip etched in an acidic solution to remove a small
amount of metal from both the outer diameter (OD) and inner diameter (ID)
surfaces. The acidic waste and rinse water from the hollow etch process is
discharged to the WWTF. This acid etch step is the basis for application of the F006 listing to Sandvik's WWTF sludge, as discussed in the following section.
      If the next pass is to produce a smaller OD or thinner wall hollow, the above three-step process is repeated until the desired sizing is accomplished resulting in a final tube.
C.	How is Sandvik's waste captured by the F006 listing definition?
      The listing definition for F006 waste at 40 C.F.R. § 261.31 states that the source definition of F006 wastes include:
      Wastewater treatment sludges from electroplating operations except from the following processes: (1) Sulfuric acid anodizing of aluminum; (2) tin plating on carbon steel; (3) zinc plating (segregated basis) on carbon steel; (4) aluminum or zinc-aluminum plating on carbon steel; (5) cleaning/stripping associated with tin, zinc and aluminum plating on carbon steel; and (6) chemical etching and milling of aluminum.
      The EPA promulgated an interpretive rule (51 FR 43350 (December 2, 1986)) clarifying the scope of EPA Hazardous Waste No. F006 contained in the list of hazardous wastes from non-specific sources of Subpart D of Part 261. This interpretive rule established that:
      The F006 listing is (and always has been) therefore, inclusive of wastewater treatment sludges from only the following processes: (1) Common and precious metals electroplating, except tin, zinc (segregated basis), aluminum, and zinc-aluminum plating on carbon steel; (2) anodizing, except sulfuric acid anodizing of aluminum; (3) chemical etching and milling, except when performed on aluminum; and (4) cleaning and stripping, except when associated with tin, zinc, and aluminum plating on carbon steel.
      Because the Sandvik production process that results in generation of the candidate WWTF sludge includes chemical etching  other than that performed on aluminum, Sandvik's WWTF sludge meets the definition of F006 listed waste.
D.	How did Sandvik sample and analyze the petitioned waste?
      Sandvik conducted a detailed chemical analysis of their WWTF sludge according to a written sampling and analysis plan (SAP), provided as Attachment 2 to the delisting petition. This SAP included the following key elements:
 A description of the manufacturing and wastewater treatment processes relevant to the delisting petitioned waste;
 An initial identification of Constituents of Potential Concern (COPCs) potentially present in the petitioned waste based on manufacturing and wastewater treatment processes;
 Development of sampling strategies to address variations and periodic fluctuations in the manufacturing and wastewater treatment processes, including obtaining representative samples to account for variations of alloys used in the manufacturing process and addition of coolant/lubricant into the filter cake.
 The proposed methodology for evaluating the resulting data with respect to anticipated delisting decision criteria; and
 A Quality Assurance Project Plan (QAPP) documenting the required  quality and quantity of the data necessary for decisions based on them to be within an acceptable degree of uncertainty.
      Sandvik's SAP identified an initial list of COPCs based on a consideration of constituents included in the F006 hazardous waste listing and present in the
manufacturing and wastewater treatment materials and processes. See Section 2 and Table 5 of Attachment 2 in Sandvik's delisting petition. Additionally, the list of COPCs included impurities and other constituents listed in the alloys and in the process and wastewater treatment chemical Safety Data Sheets (SDS). Constituents were then evaluated
 based on historical detections in the filter cake waste and compared to constituents listed
in the following RCRA regulations, as applicable to the Kennewick facility and this specific filter cake waste:
 Constituent for which F006 was listed (40 C.F.R. Part 261 Appendix VII; WAC 173-303-082) or listed as a Land Disposal Restriction (LDR) constituent subject to treatment for F006 or identified as a constituent for which an LDR Universal Treatment Standard has been established (40 C.F.R. §§ 268.40 and 268.48; WAC 173-303-140) with the exception of cyanide. Cyanide was not retained as a COPC, because there is no documented use of cyanide at the Kennewick facility and it was not detected in historical filter cake samples.
 Constituent has been historically detected in filter cake and was present on the Toxicity Characteristics List (40 C.F.R. § 261.24; WAC 173-303-090 Part 8), Hazardous Constituents List (40 C.F.R. Part 261 Appendix VIII; WAC<PHONE_NUMBER>), and/or Groundwater Monitoring List (40 C.F.R. Part 264 Appendix IX; WAC 173-303-110(7)).
 According to the alloy composition, constituent could potentially be present in the filter cake and is listed on the Toxicity Characteristics List (40 C.F.R. § 261.24; WAC 173-303-090(8)), Hazardous Constituents List (40 C.F.R. Part 261 Appendix VIII; WAC<PHONE_NUMBER>), and/or the Groundwater Monitoring List (40 C.F.R. Part 264 Appendix IX; WAC 173-303-110 Part 7).
A constituent was not retained as a COPC if it was not:
 Listed on potentially relevant regulatory lists; or
 There was no documented Kennewick facility use of the constituent, or it was a minor constituent in wastewater treatment material, not detected in historical filter cake samples, or converted to another COPC in the wastewater treatment process (i.e., hydrofluoric acid is present as fluoride in the filter cake).
Based on this analysis, Sandvik's SAP proposed the following list of COPCs: Arsenic; Barium; Cadmium; Chromium (including hexavalent chromium); Cobalt; Copper; Fluoride; Lead; Nickel; Silver; Tin; Vanadium; and Zinc. Details of Sandvik's identification of COPCs can be found in Table 5 in Attachment 2 to the delisting petition.
      The objectives of the waste characterization sampling conducted by Sandvik were as follows:
       To supplement the existing historical data set with total and TCLP data for the identified COPCs;
       To collect samples that are representative of process variations that include processing of two different alloy materials (titanium and zirconium) and the periodic addition of the waste coolant/lubricant to the filter cake waste;
       To assess acute toxicity effects of wastes in accordance with the Washington State Department of Ecology's 80-1212, Part A protocol, and
       To generate a representative data set that can be used in the Delisting Risk Assessment Software (DRAS) modeling.
      To achieve these objectives, Sandvik collected six (6) representative samples over three (3) sampling events that included the following scope of work:
       Each event included the collection of one filter cake sample with the used coolant/lubricant waste stream and one filter cake sample without the used coolant/lubricant waste stream;
       Since titanium raw materials are present at higher weight composition percentages than zirconium, four filter cake samples (two with coolant and two without coolant) events were obtained when only titanium alloys were being run in the manufacturing process; and
       To account for the use of zirconium, two samples (one with coolant and one without coolant) were obtained while zirconium alloys were also being run in the manufacturing process (in addition to titanium alloys).
      All samples were analyzed for total and TCLP COPCs, where applicable. If chromium was detected at a concentration above the laboratory practical quantitation limit (PQL), a sample from the same sampling event was analyzed for hexavalent chromium. If chromium was not detected above the PQL, no additional testing was performed. This approach to sampling for chromium was used for both total and TCLP sampling.
      One sample with the coolant/lubricant and one sample without the coolant/lubricant was analyzed to assess acute toxicity via bioassay as part of the first titanium-only sampling events. This combination of the filter cake production characteristics is expected to be the most conservative choice for bioassay testing, given the higher number of impurities in the titanium alloy. Additional details of Sandvik's waste characterization sampling activities are provided in Attachment 2 to the delisting petition.
D.	What were the results of Sandvik's analysis of its waste?
      Sandvik provided results of their waste characterization activities in Attachment 3 to the delisting petition entitled "Sampling Results and Data Evaluation Report." As part of its overall delisting petition submission, Sandvik submitted a signed statement certifying that information in the petition, including their submission of waste characterization data and description of the associated sampling and analysis activities, is true, accurate and complete, and the responsibilities of the signatory of the delisting petition. See 40 C.F.R. § 260.22(i)(12).
      Sandvik conducted its first sampling event on July 31, 2017, followed by two additional sampling events on August 31 and September 25, 2017. Two representative samples of the WWTF filter cake were collected during each event, one with the used coolant/lubricant waste stream and one without, for a total of six filter cake samples. Of these six samples, four were collected when only titanium alloys were being run in the manufacturing process, and two when zirconium was also being run. Each sample was a composite sample collected from four separate locations within each filter cake collection bin used to collect the filter cake following the filter press. Sandvik's delisting petition states that according to facility representatives, the filter cake generation durations and resulting volumes within the filter press during each sampling event were typical for facility operations. Additional details of Sandvik's waste characterization sampling activities can be found in Section 3 of the SAP (Attachment 2 of the delisting petition).
      Sandvik performed a quality assurance/quality control review of each laboratory report, with complete results of the data validation review detailed in Appendix C of the SAP.
      Based on the results of filter cake characterization sampling, Sandvik concluded that all constituents other than hexavalent chromium should be retained as constituents of concern for further evaluation. Sandvik's deletion of hexavalent chromium from the list of COPCs is based on hexavalent chromium not being detected in any of the filter cake total or TCLP analysis according to the sampling methodology described above.
      Sandvik compared their 2017 waste characterization sampling results to historical total and TCLP results available for several of the COPCs. The range of recent COPC results was consistent with historical results except for fluoride. Historical total fluoride concentrations of 67,500 mg/kg and 42,000 mg/kg from 1991 and 1997, respectively, were several orders of magnitude higher than recent concentrations; the highest recent concentration was 907 mg/kg. Sandvik indicates that it has progressively reduced the amount of etching in its process at the Kennewick facility, which would result in a decline in hydrofluoric acid use and fluoride in the filter cake. In addition, the collection method of the historical samples as well as the production and wastewater treatment system operations at the time of historical sampling are unknown. As a result, the 2017 samples are considered to be more representative of typical conditions for fluoride for current and future operations at the Kennewick facility.
      Overall, totals concentrations from the three 2017 sampling events were within the range of historical results. In addition to fluoride, as discussed in the previous paragraph, one 2017 maximum nickel sample (425 mg/kg) exceeded the historical maximum nickel sample of 392 mg/kg. The 2017 totals samples also exceeded historical maximum concentrations for arsenic, barium, chromium, and silver, but none of these constituents had a difference of more than one order of magnitude between the 2017 and historic samples. Because most historical concentrations are from 20 or more years ago and production and collection methods are unknown, the 2017 COPC results obtained from implementation of the SAP were considered more reliable and used for the subsequent data evaluation.
	Sandvik also compared the 2017 waste characterization sampling result to the toxicity characteristic (TC) regulatory standard for those waste constituents for which regulatory standards have been established. Based on this comparison, Sandvik concluded that the candidate wastes do not exhibit the toxicity characteristic. Although Sandvik did not explicitly evaluate their candidate wastes for the characteristics of ignitability, reactivity or corrosivity, the EPA agrees that process knowledge provides an adequate demonstration that the wastes in question do not exhibit the enumerated characteristics.
E.	How did EPA evaluate the risk of delisting this waste?
      For this delisting determination, we assumed that the waste would be disposed in a Subtitle D landfill and we considered transport of waste constituents through ground water, surface water and air.  We evaluated Sandvik's analysis of petitioned waste using the Agency's Delisting Risk Assessment Software (DRAS) to predict the concentration of hazardous constituents that might be released from the petitioned waste and to determine if the waste would pose a threat to human health and the environment. The DRAS software and associated documentation can be found at www.epa.gov/hw/hazardous-waste-delisting-risk-assessment-software-dras.
      To predict the potential for release to groundwater from landfilled wastes and subsequent routes of exposure to a receptor, the DRAS uses dilution attenuation factors derived from EPA's Composite Model for leachate migration with Transformation Products.  From a release to ground water, the DRAS considers routes of exposure to a human receptor of ingestion of contaminated groundwater, inhalation from groundwater while showering and dermal contact from groundwater while bathing.
      From a release to surface water by erosion of waste from an open landfill into storm water run-off, DRAS evaluates the exposure to a human receptor by fish ingestion and ingestion of drinking water.  From a release of waste particles and volatile emissions to air from the surface of an open landfill, DRAS considers routes of exposure of inhalation of volatile constituents, inhalation of particles, and air deposition of particles on residential soil and subsequent ingestion of the contaminated soil by a child.  The technical support document and the user's guide to DRAS are included in the docket.
 	Sandvik documented the input parameters used in their DRAS analysis, as summarized below:
                            Table 1  -  DRAS Input
DRAS Input Parameter
                                     Value
Assumptions
Waste Management Unit Type
                                   Landfill
Waste planned for disposal in the Finley Buttes Municipal Landfill, Boardman, Oregon
Waste Volume  -  annual generation
                            1,500 cubic yards/year
Conservative estimation value based on facility-specific information
Waste Management Unit Active Life
                                   20 years
Selected based on the DRAS default value
Target risk  -  carcinogenic risk level
                                   1x10[-5]
Based on risk ranges in EPA's RCRA Delisting Technical Support Document (2008)
Target risk  -  health quotient
                                      1.0
Based on risk ranges in EPA's RCRA Delisting Technical Support Document (2008)

      At a target cancer risk of 110[-5] and a target hazard quotient of 1.0, the DRAS program determined maximum allowable concentrations for each constituent in both the waste and the leachate at an annual waste volume of 1,500 cubic yards. Sandvik used the maximum estimated annual waste volume and the maximum reported total and estimated leachate concentrations as inputs to estimate the constituent concentrations in the ground water, soil, surface water or air.  The following table documents the constituent-specific maximum total and TCLP sample results used as input to the DRAS analysis, and the resulting modeling results from DRAS. The EPA notes that it has independently conducted its own DRAS modeling run, and has verified the modeling results documented by Sandvik in its delisting petition.
              Table 2  -  Sampling Data and DRAS Modeling Results
Constituent of Concern
                       Maximum Observed Concentration[1]
                               Modeling Results

                             Total Concentrations
                              TCLP Concentration

                                Total[1](mg/kg)
                                 TCLP(mg/L)[4]
                       Limiting Concentration (mg/kg)[2]
                              Limiting Pathway[3]
                        Limiting Concentration (mg/L) 2
                              Limiting Pathway[3]

Arsenic
                                     4.77
                                    0.05 U
                                     9,840
                                Fish Ingestion
                                     0.042
                                 GW Ingestion
Barium
                                     24.1
                                    0.05 U
                                  21,300,000
                                Fish Ingestion
                                      176
                                      MCL
Cadmium
                                     15.0
                                    0.05 U
                                    37,100
                                Fish Ingestion
                                     0.451
                                      MCL
Chromium
                                     44.3
                                    0.05 U
                                    77,500
                          Air Particulate Inhalation
                                     9.54
                                      MCL
Cobalt
                                      291
                                     0.255
                                    103,000
                          Air Particulate Inhalation
                                     1.06
                                 GW Ingestion
Copper
                                     26.2
                                     0.057
                                   3,790,000
                                Fish Ingestion
                                      120
                                      MCL
Fluoride
                                      907
                                      114
                                 1,490,000,000
                                     Soil
         194
                                 GW Ingestion
Lead
                                     11.1
                                    0.05 U
                                   8,870,000
                          Air Particulate Inhalation
                                     2.95
                                      MCL
Nickel
                                      425
                                     0.466
                                   3,870,000
                          Air Particulate Inhalation
                                     66.4
                                 GW Ingestion
Silver
                                     5.76
                                    0.05 U
                                   3,830,000
                                Fish Ingestion
                                     38.8
                                 GW Ingestion
Tin
                                      268
                                    0.05 U
                                14,900,000,000
                                     Soil
                                  192,000,000
                                 GW Ingestion
Vanadium
                                     1,500
                                    0.05 U
                                  124,000,000
                                     Soil
                                     16.9
                                 GW Ingestion
Zinc
                                     69.4
                                     0.233
                                   9,810,000
                                Fish ingestion
                                      992
                                 GW Ingestion
1.	Maximum concentration obtained during implementation of the 2017 Sampling and Analysis Plan (Geosyntec, 2017)
2. 	The Limiting Concentration is the lowest risk-based concentration developed in DRAS for the potential receptor pathways and specified target risk levels.
3.	The Limiting Pathway is the corresponding potential receptor pathway for the Limiting Concentration.
4.	For detected constituents, the maximum analytical result was used. For non-detect constituents (annotated with a "U"), the practical quantitation limit (PQL) was used.
	Note:	Italicized cells indicate exceedance of COPC Concentration Input over the Limiting Concentration in the DRAS modeling.

F.	What did EPA conclude about Sandvik's waste?

      The maximum reported concentrations of the hazardous constituents found in this waste are presented in the table above.  The table also presents the maximum allowable concentrations.  Except for the groundwater pathway for arsenic, the concentrations of all constituents in both the waste and the leachate are below the allowable concentrations.
      For arsenic, the maximum reported concentration was undetected at a value of 0.05 mg/L, a value slightly higher than the maximum allowable TCLP concentration of 0.042 mg/L. The EPA's review of the corresponding laboratory reports indicate that the laboratory reported sample results from the July 31, 2017 characterization sampling round as non-detect based on a practical quantitation limit of 0.05 mg/L. Subsequent laboratory reports for the August 31, 2017 and October 4, 2017 characterization rounds, however, reported TCLP arsenic results as non-detect at a level of 0.001 mg/L, based on a lower method detection limit rather a practical quantitation limit. Since the total arsenic results for all characterization samples are both low and consistent, ranging from 2.02 to 4.77 mg/kg, the EPA believes that the TCLP arsenic results for the July 31, 2017 results are not likely to be materially different than lower non-detect results for the August 31, 2017 and October 4, 2017 sample results. Therefore, the EPA concludes that even though the TCLP arsenic data from the August 31, 2017 laboratory report does not meet the practical quantitation limit of 0.05 mg/L,  the overall data set clearly supports a conclusion that the TCLP arsenic results do not exceed the maximum allowable concentration of 0.042 mg/L from any of the characterization sampling rounds, and that based on the difference in arsenic concentrations from totals analysis (detected at low levels) and TCLP samples (non-detect), arsenic appears to be immobile in the filter cake, and would not provide a complete exposure pathway. Should the EPA grant the requested delisting petition, Sandvik must ensure that any required periodic verification sampling and analysis must meet appropriate data quality standards to address this issue.
      We therefore conclude that Sandvik's wastewater treatment sludge is not a substantial or potential hazard to human health and the environment when disposed of in a Subtitle D landfill. Further, the data presented by Sandvik in their petition supports the EPA's conclusion that the petitioned waste does not exhibit any hazardous characteristic, and that there are no other factors that would warrant retaining the waste as hazardous. On this basis, we propose to grant the Sandvik's petition to delist this waste.  If this exclusion is finalized, Sandvik must dispose of this waste in a Subtitle D landfill permitted or licensed by a state and will remain obligated to verify that the waste continues to meet the allowable concentrations set forth here.  Sandvik must also continue to demonstrate that the waste exhibits any hazardous characteristics pursuant to 40 C.F.R. Part 261 Subpart C.
IV.	Conditions for Exclusion
A.	When would EPA finalize the proposed delisting exclusion?
      HSWA specifically requires the EPA to provide notice and an opportunity for comment before granting or denying a final exclusion.  Thus, EPA will not make a final decision or grant an exclusion until it has addressed all timely public comments on today's proposal, including any at public hearings.

      Since this rule would reduce the existing requirements for persons generating hazardous wastes, the regulated community does not need a six-month period to come into compliance in accordance with § 3010 of RCRA as amended by HSWA.
B.	How will Sandvik manage the waste if it is delisted?
      If the petitioned waste is delisted, Sandvik must dispose of it in a Subtitle D landfill which is permitted, licensed, or registered by a state to manage industrial waste.
C.	What are the maximum allowable concentrations of hazardous constituents in the waste?
      Concentrations measured in the waste of the following constituents must not exceed the following (mg/l):
      Table 3  -  Verification Constituents and Compliance Concentrations
Constituent
Total Concentration (mg/kg)
TCLP Concentration (mg/l)
Arsenic
9,840
0.042
Barium
N/A
176
Cadmium
37,100
0.451
Chromium
77,500
9.54
Cobalt
103,000
1.06
Copper
N/A
120
Fluoride
N/A
194
Lead
N/A
2.95
Nickel
N/A
66.4
Silver
N/A
38.8

Vanadium
N/A
16.9
Zinc
N/A
992

      The EPA notes that in multiple instances the maximum allowable constituent concentrations provided by the DRAS model exceed 100% of the waste  -  these DRAS results are an artifact of the risk calculations that do not have physical meaning. In instances where DRAS predicts a maximum constituent greater than 100% of the waste (that is, greater than 1,000,000 mg/kg or mg/L, respectively, for total and TCLP concentrations), the EPA is not requiring Sandvik to perform sampling and analysis for that constituent and sampling type (total or TCLP). In these instances, the corresponding entry in Table 3 above is "N/A."
D.	How frequently must Sandvik test the waste?

      Sandvik must analyze a representative sample of the wastewater treatment sludges on an annual basis to demonstrate that the constituents of concern in the petitioned waste do not exceed the concentrations of concern in section IV.C above.  Sandvik must use methods with sufficient analytical sensitivity and appropriate quality control procedures.  SW-846 Method 1311 must be used for generation of the leachate extract used in the testing of the subject waste. SW-846 Method 1311 is incorporated by reference in 40 C.F.R. § 260.11.
      A total analysis of the waste (accounting for any filterable liquids and the dilution factor inherent in the TCLP method) may be used to estimate the TCLP concentration as provided for in section 1.2 of Method 1311. The EPA is not requiring Sandvik to use Method 1330 for extraction of wastes, since Method 1330 is applicable to API separator sludges, rag oils, slop oil emulsions, and other oil wastes derived from petroleum refining, which are fundamentally different wastes than those proposed by Sandvik for delisting.
E.	What data must Sandvik submit?
      Sandvik must submit the data obtained through annual verification testing to U.S. EPA Region 10, Office of Air and Waste, 1200 6[th] Ave., Suite 155, M/S OAW-150, Seattle, WA 98101 upon each anniversary of the effective date of this exclusion.  Sandvik must submit sampling data from both titanium and zirconium manufacturing processes, provided that both of these materials have been in production and contributed to candidate wastes within the three-month period prior to each anniversary of the effective date of this delisting. If both materials are not in production with the specified three-month period, then only data from that material in production need be submitted.
      Sandvik must compile, summarize, and maintain on site records of operating conditions and analytical data.  Sandvik must make these records available for inspection.  All data must be accompanied by a signed copy of the certification statement in 40 C.F.R. § 260.22(i)(12).
F.	What happens if Sandvik fails to meet the conditions of the exclusion?
      If Sandvik violates the terms and conditions established in the exclusion, the Agency may start procedures to withdraw the exclusion.

      If the verification testing of the waste does not meet the delisting concentrations described in section IV.C above or other data (including but not limited to leachate data or groundwater monitoring data from the final land disposal facility) relevant to the delisted waste indicates that any constituent is at a concentration in waste above specified delisting verification concentrations in Table 3, Sandvik must notify the Agency within 10 days of first possessing or being made aware of the data.  The exclusion will be suspended and the waste managed as hazardous until Sandvik has received written approval from the EPA to continue the exclusion.  Sandvik may provide sampling results which support the continuation of the delisting exclusion.
      The EPA has the authority under RCRA and the Administrative Procedures Act, 5 U.S.C. § 551 (1978) et seq. to reopen a delisting decision if we receive new information indicating that the conditions of this exclusion have been violated, or are otherwise not being met.
G.	What must Sandvik do if the process changes?
      If Sandvik significantly changes the manufacturing or treatment process or the chemicals used in the manufacturing or treatment process, Sandvik may not handle the wastewater treatment sludge generated from the new process under this exclusion until it has demonstrated to the EPA that the waste meets the concentrations set forth in section IV.C and that no new hazardous constituents listed in Appendix VIII of 40 C.F.R. Part 261 have been introduced.  Sandvik must manage wastes generated after the process change as hazardous waste until Sandvik has received written notice from EPA that the demonstration has been accepted.

V.	How would this action affect the states?
      Because EPA is proposing to issue this exclusion under the federal RCRA delisting regulations, only states subject to federal RCRA delisting provisions will be affected.  This exclusion may not be effective in states which have received authorization from the EPA to make their own delisting decisions.
      EPA allows states to impose their own non-RCRA regulatory requirements that are more stringent than EPA's, under § 3009 of RCRA.  These more stringent requirements may include a provision that prohibits a federally issued exclusion from taking effect in the state.  We urge petitioners to contact the state regulatory authority to establish the status of their wastes under the state law.
      EPA has also authorized some states to administer a delisting program in place of the federal program, that is, to make state delisting decisions.  Therefore, this exclusion does not apply in those authorized states.  If Sandvik manages the waste in any state with delisting authorization, Sandvik must obtain delisting authorization from that state before it can manage the waste as nonhazardous in that state.
      While Washington State has received final authorization to implement most of its dangerous waste program regulations in lieu of the federal program, including the listing and identification of F006 wastes (See 51 FR 3782 (January 30, 1986), it has not been authorized to implement its delisting regulations program in lieu of the federal program. The EPA notes that Washington State has provisions in the Washington Administrative Code (WAC) 173-303-910(3) similar to the federal provisions upon which this delisting is based. These provisions are in effect as a matter of state law. Thus, Sandvik must seek approval from Washington State at the state level in addition to this proposed delisting.
VI. Statutory and Executive Order Reviews
	Under Executive Order 12866, "Regulatory Planning and Review " (58 FR 51735, October 4, 1993), this rule is not of general applicability and therefore, is not a regulatory action subject to review by the Office of Management and Budget (OMB).  This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. § 3501 et seq.) because it applies to a particular facility only.  Because this rule is of particular applicability relating to a particular facility, it is not subject to the regulatory flexibility provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), or to §§ 202, 204, and 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4).  Because this rule will affect only a particular facility, it will not significantly or uniquely affect small governments, as specified in § 203 of UMRA.  Because this rule will affect only a particular facility, this final rule 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, as specified in Executive Order 13132, "Federalism", (64 FR 43255, August 10, 1999).  Thus, Executive Order 13132 does not apply to this rule.
	Similarly, because this rule will affect only a particular facility, this final rule does not have tribal implications, as specified in Executive Order 13175, "Consultation and Coordination with Indian Tribal Governments" (65 FR 67249, November 9, 2000).  Thus, Executive Order 13175 does not apply to this rule.  This rule also is not subject to Executive Order 13045, "Protection of Children from Environmental Health Risks and Safety Risks" (62 FR 19885, April 23, 1997), because it is not economically significant as defined in Executive Order 12866, and because the Agency does not have reason to believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. The basis for this belief is that the Agency used DRAS, which considers health and safety risks to children, to calculate the maximum allowable concentrations for this rule.  This rule is not subject to Executive Order 13211, "Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use" (66 FR 28355, May 22, 2001), because it is not a significant regulatory action under Executive Order 12866.  This rule does not involve technical standards; thus, the requirements of § 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply.  As required by § 3 of Executive Order 12988, "Civil Justice Reform", (61 FR 4729, February 7, 1996), EPA has taken the necessary steps in issuing this rule to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct.
	The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report which includes a copy of the rule to each House of the Congress and to the Comptroller General of the United States.  Section 804 exempts from § 801 the following types of rules: (1) Rules of particular applicability; (2) rules relating to agency management or personnel; and (3) rules of agency organization, procedure, or practice that do not substantially affect the rights or obligations of non-agency parties (5 U.S.C. § 804(3)).  EPA is not required to submit a rule report regarding today's action under § 801 because this is a rule of particular applicability.
List of Subjects in 40 C.F.R. Part 261
      Hazardous waste, Recycling, and Reporting and recordkeeping requirements.
      Authority:  § 3001(f) RCRA, 42 U.S.C. § 6921(f).

Date

______________________________________
Timothy B. Hamlin
Director
Office of Air and Waste

      For the reasons set out in the preamble, EPA proposes to amend 40 C.F.R. Part 261 as follows:

PART 261--IDENTIFICATION AND LISTING OF HAZARDOUS WASTE
1. The authority citation for part 261 continues to read as follows:
      Authority: 42 U.S.C. 6905, 6912(a), 6921, 6922, and 6938.

2. In Table 1 of Appendix IX to part 261 add the following waste stream in alphabetical order by facility to read as follows:
Appendix IX to part 261 - Wastes Excluded Under §§ 260.20 and 260.22.

Table 1--Wastes Excluded From Non-Specific Sources

Facility			Address		Waste description

          *          *          *          *          *
Sandvik Special Metals
Kennewick, Washington	Wastewater treatment sludges, F006, generated at Sandvik Special Metals (Sandvik) facility in Kennewick, Washington at a maximum annual rate of 1,500 cubic yards per year.  The sludge must be disposed of in a Subtitle D landfill which is licensed, permitted, or otherwise authorized by a state to accept the delisted wastewater treatment sludge.  The exclusion becomes effective as of [insert final publication date].
                              1. Delisting Levels:
                              (A) The constituent concentrations in a representative sample of the waste must not exceed the following levels: Total concentrations (mg/kg): Arsenic  -  9,840; Cadmium  -  37,100; Chromium  -  77,500; Cobalt  -  103,000. TCLP Concentrations (mg/l in the waste extract): Arsenic  -  0.042; Barium  -  176; Cadmium  -  0.451; Chromium  -  9.54; Cobalt  -  1.06; Copper  -  120; Fluoride  -  194; Lead  -  2.95; Nickel  -  66.4; Silver  -  38.8; Vanadium  -  16.9; Zinc  -  992.
                              2. Annual Verification Testing:  To verify that the waste does not exceed the delisting concentrations specified in Section 1.A, Sandvik must collect and analyze one representative waste sample with coolant on an annual basis no later than each anniversary of the effective date of this delisting using methods with appropriate detection concentrations and elements of quality control.   If both titanium and zirconium products have been in production and contributed to candidate wastes within the three-month period prior to each anniversary of the effective date of this delisting, samples of waste from both manufacturing processes must be collected for that reporting cycle.  Otherwise, sampling only of that material in production within the specified three-month period is required."
                              Sampling data must be provided to the EPA no later 60 days following each anniversary of the effective date of this delisting, or such later date as the EPA may agree to in writing. Sandvik must conduct all verification sampling according to a written sampling plan and associated quality assurance project plan that ensures analytical data are suitable for their intended use, which must be made available to the EPA upon request. Sandvik's annual submission must also include a certification that all wastes satisfying the delisting concentrations in Condition 1.A have been disposed of in a Subtitle D landfill which is licensed, permitted, or otherwise authorized by a state to accept the delisted wastewater treatment sludge.
                              3. Changes in Operating Conditions: Sandvik must notify the EPA in writing if it significantly changes the manufacturing process, the chemicals used in the manufacturing process, the treatment process, or the chemicals used in the treatment process. Sandvik must handle wastes generated after the process change as hazardous until it has demonstrated that the wastes continue to meet the delisting concentrations in section 1.C; demonstrated that no new hazardous constituents listed in 40 C.F.R. Part 261 Appendix VIII have been introduced into the manufacturing process or waste treatment process; and it has received written approval from the EPA that it may continue to manage the waste as non-hazardous.
                              4. Data Submittals: Sandvik must submit the data obtained through verification testing or as required by other conditions of this rule to the Director, Office of Air and Waste, U.S. EPA Region 10, 1200 6[th] Ave., Suite 155, M/S-150, Seattle, Washington, 98070 or his or her equivalent.  The annual verification data and certification of proper disposal must be submitted within 60 days after  each anniversary of the effective date of this delisting exclusion.  Sandvik must compile, summarize, and maintain on-site for a minimum of five years, records of operating conditions and the analytical data required by this rule.  Sandvik must make these records available for inspection.  All data must be accompanied by a signed copy of the certification statement in 40 C.F.R. § 260.22(i)(12).

                              5. Reopener Language - Sandvik may provide sampling results which support the continuation of the delisting exclusion. (A) If, any time after disposal of the delisted waste, Sandvik possesses or is otherwise made aware of any data relevant to the delisted waste indicating that any constituent is at a higher than the specified delisting concentration, then Sandvik must report such data, in writing, to the Director, Office of Air and Waste, U.S. EPA Region 10, or his or her equivalent, within 10 days of first possessing or being made aware of that data.  (B) Based on the information described in paragraph (A) and any other information received from any source, the EPA will make a preliminary determination as to whether the reported information requires Agency action to protect human health or the environment.  Further action may include suspending, or revoking the exclusion, or other appropriate response necessary to protect human health and the environment.
                              (C) If the EPA determines that the reported information does require Agency action, the EPA will notify Sandvik in writing of the actions it believes are necessary to protect human health and the environment.  The notice shall include a statement of the proposed action and a statement providing Sandvik with an opportunity to present information as to why the proposed Agency action is not necessary or to suggest an alternative action.  Sandvik shall have 30 days from the date of the EPA's notice to present the information. (D) If after 30 days Sandvik presents no further information or after a review of any submitted information, the EPA will issue a final written determination describing the Agency actions that are necessary to protect human health or the environment.  Any required action described in the EPA's determination shall become effective immediately, unless the EPA provides otherwise.
 	*		*		*		*		*