[Federal Register: May 5, 2010 (Volume 75, Number 86)]
[Notices]
[Page 24688-24689]
[DOCID:fr05my10-75]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2003-0004; FRL-8821-5]

Access to Confidential Business Information by Guident
Technologies Inc.'s Identified Subcontractor

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA has authorized a subcontractor of its prime contractor,
Guident Technologies Inc. of [Herndon, VA, to access information which
has been submitted to EPA under all sections of the Toxic Substances
Control Act (TSCA). Some of the information may be claimed or
determined to be Confidential Business Information (CBI).

DATES:  Access to the confidential data will occur no sooner than May
12, 2010.

FOR FURTHER INFORMATION CONTACT: For general information contact: Colby
Lintner, Regulatory Coordinator, Environmental Assistance Division
(7408M), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; e-mail address: TSCA-
<EMAIL_ADDRESS>    For technical information contact: Scott Sherlock, Environmental
Assistance Division (7408M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Notice Apply to Me?

    This action is directed to the public in general. This action may,
however, be of interest to all who manufacture, process or distribute
industrial chemicals. Since other entities may also be interested, the
Agency has not attempted to describe all the specific entities that may
be affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the
technical person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

     Docket. EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPPT-2003-0004. All documents in the

docket are listed in the docket index available at http://
www.regulations.gov. Although, listed in the index, some information is
not publicly available, e.g., CBI or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, will be publicly available only in hard copy. Publicly
available docket materials are available electronically at http://
www.regulations.gov, or, if only available in hard copy, at the OPPT
Docket. The OPPT Docket is located in the EPA Docket Center (EPA/DC) at
Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC.
The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding Federal holidays. The telephone
number of the EPA/DC Public Reading Room is<PHONE_NUMBER>, and the
telephone number for the OPPT Docket is<PHONE_NUMBER>. Docket visitors
are required to show photographic identification, pass through a metal
detector, and sign the EPA visitor log. All visitor bags are processed
through an X-ray machine and subject to search. Visitors will be
provided an EPA/DC badge that must be visible at all times in the
building and returned upon departure.

II. What Action Is the Agency Taking?

    Under Contract Number GS-35F-0799M, Order Number EP09D000603,
contractor Guident Technologies Inc. of 198 Van Buren Street, Suite
120, Herndon, VA and subcontractor Logistics Management Institute of
2000 Corporate Ridge, McLean, VA will assist the Office of Pollution
Prevention and Toxics (OPPT) in performing development, maintenance,
and operations for the Confidential Business Information Systems and
for Test Confidential Business Information Tracking Systems (CBITS) and
(TCBITS).
    In accordance with 40 CFR 2.306(j), EPA has determined that under
Contract Number GS--35F-0799M, Order Number EP09D000603, Guident
Technologies Inc. and its subcontractor will require access to CBI
submitted to EPA under all sections of TSCA to perform successfully the
duties specified under the contract. Guident Technologies Inc. and its
subcontractor's personnel will be given access to information submitted
to EPA under all sections of TSCA.
    EPA is issuing this notice to inform all submitters of information
under all sections of TSCA that EPA may provide Guident Technologies
Inc. and its subcontractor access to these CBI materials on a need-to-
know basis only. All access to TSCA CBI under this contract will take
place at EPA Headquarters in accordance with EPA's TSCA CBI Protection
Manual.
     Access to TSCA data, including CBI, will continue until September
1, 2010. If the contract is extended, this access will also continue
for the duration of the extended contract without further notice.
     Guident Technologies Inc. and its subcontractor's personnel will
be required to sign nondisclosure agreements and will be briefed on
appropriate security procedures before they are permitted access to
TSCA CBI.

List of Subjects

    Environmental protection, Confidential Business Information.

    Dated: March 8, 2010.
 Matthew Leopard,
Director, Information Management Division, Office of Pollution
Prevention and Toxics.
[FR Doc. 2010-10230 Filed 5-4-10; 8:45 am]
BILLING CODE 6560-50-S


[Federal Register Volume 76, Number 140 (Thursday, July 21, 2011)]
[Notices]
[Pages 43693-43694]
[FR Doc No: 2011-18387]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0477]

Standard Operating Procedure for ``Notice to Industry'' Letters

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the standard operating procedure (SOP) for ``Notice to
Industry'' Letters. The SOP describes the Center for Devices and
Radiological Health's (CDRH) process to clarify and more quickly inform
stakeholders when CDRH has changed its expectations relating to, or
otherwise has new scientific information that could affect, data
submitted as part of an Investigational Device Exemption (IDE) or
premarket submission that needs to be disseminated in a timely manner.

DATES: The Agency encourages interested parties to submit information
and either electronic or written comments by September 19, 2011.

ADDRESSES: Submit electronic comments or information to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Angela Krueger, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1666, Silver Spring, MD 20993,<PHONE_NUMBER>, e-
mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The Task Force on the Utilization of Science in Regulatory Decision
Making (the Task Force) published a Preliminary Report and
Recommendations in August 2010. In the report, the Task Force noted
that when new scientific information changes CDRH's regulatory
thinking, it has been challenging for the Center to communicate the
change and its basis to all affected parties in a meaningful and timely
manner. The Task Force recommended that the Center make use of more
rapid tools for broad communication on regulatory matters, including
establishing a standard practice for sending ``Notice to Industry''
Letters to all manufacturers of a particular group of devices for which
the Center has changed its expectations for data submitted as part of
an IDE or premarket application on the basis of new scientific
information.
    Currently, manufacturers typically learn of changes CDRH implements
at the time of or soon after a decision is made through individual
engagement with the Center, often not until after they have prepared a
premarket submission. Reviewers may implement these changes, such as
requesting new clinical data or using a new test method, on a case by
case basis, with immediate supervisory concurrence when it is necessary
to protect the public health. For example, a reviewer may request that
sponsors test their implantable device for durability because new data
demonstrates that this type of device is prone to failure due to
premature wear and tear of the technology. Although CDRH may issue a
detailed guidance document, the document may not be published until a
year or more after a branch- or division-level decision has been made
to request the information because of the resource constraints in
developing guidance documents.
    Therefore, CDRH believes that timely communication with industry
about changes in regulatory expectations or new scientific information
is important. The Task Force recommended that CDRH use ``Notice to
Industry'' Letters in these circumstances, although not required, and
adopt a uniform template and terminology for such letters, including
clear and consistent language to indicate that the Center has changed
its regulatory expectations, the general nature of the change, and the
rationale for the change. The Task Force contemplated that CDRH could
potentially issue ``Notice to Industry'' Letters, if such letters
constitute guidance, as ``Level 1--Immediately in Effect'' guidance
documents under 21 CFR 10.115(g)(2), and would open a public docket
upon their issuance through a notice of availability in the Federal
Register.
    This SOP was developed to address this recommendation from the Task
Force. Where appropriate, CDRH will communicate new expectations as
``Notice to Industry'' Guidance Letters, which will comply with Good
Guidance Practices, or CDRH will communicate other new scientific
information as ``Notice to Industry'' Advisory Letters. The Center will
post both types of ``Notice to Industry'' Letters on its Web site, and
will also use additional methods for distributing the Letters to
identified stakeholders. When CDRH issues a ``Notice to Industry''
Guidance Letter concerning a change in premarket expectations that will
affect pending

submissions, the Center will generally specify an additional amount of
time for sponsors of those submissions to address the new issues. Where
appropriate, ``Notice to Industry'' Guidance Letters would be followed
as quickly as possible by new or revised guidance explaining the
Center's new regulatory expectations (if any) in greater detail and
revising the guidance where necessary in response to comments received,
so that external constituencies have a fuller understanding of the
Center's current regulatory thinking.

II. Submission of Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: July 15, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-18387 Filed 7-20-11; 8:45 am]
BILLING CODE 4160-01-P


Meeting Minutes

The Maritime Advisory Committee for Occupational Safety and Health
(MACOSH)

January 10, 2010

The Maritime Advisory Committee for Occupational Safety and Health
convened its fourth meeting under the current charter at 9:05 A.M. on
January 10, 2010, at the U.S. Department of Labor, 200 Constitution
Avenue, N.W., Washington, D.C.  20210.  The meeting adjourned at 3:23
P.M.

In accordance with the provisions of the Federal Advisory Committee Act,
Public Law 92-463, the full Committee meeting and the workgroup meetings
held on January 9, 2010, were open to the public.

Committee members present were:

James Thornton, Chairman - Northrup Grumman Newport News Shipyard

Stewart Adams - U.S. Department of the Navy

Alan Davis - American Seafoods Company

Michael J. Flynn - International Association of Machinists and Aerospace
Workers

Alton H. Glass, Sr. - United Steelworkers

Lesley E. Johnson – International Brotherhood of Electrical Workers

Kenneth Killough – South Carolina Stevedores Association

Charles Lemon - Washington State Department of Labor and Industries

Jennifer Lincoln – NIOSH

George Lynch --  International Longshoremen’s Association

Marc MacDonald – Pacific Maritime Association

Tim Podue – International Longshore and Warehouse Union

Donald V. Raffo – General Dynamics

Kenneth A. Smith – U.S. Coast Guard

OSHA Committee Staff in attendance were:

Joseph V. Daddura, Designated Federal Official

Susan Brinkerhoff, Counsel

Veneta Chatmon, OSHA Exhibits Manager

Christie Garner, Administrative Assistant

Amy Wangdahl, Shipyard Workgroup Representative

Danielle Watson, MACOSH Liaison

Vanessa Welch, Longshore Workgroup Representative

Staff of the Occupational Safety and Health Administration in
attendance:

Steve Butler, Director, Office of Maritime Compliance

Paul Comolli, Office of Maritime, Directorate of Enforcement Programs

Angelo Costa, Compliance Officer, Region III

David Doucet, Compliance Officer, Region VI

Brian Drake, Compliance Officer, Region VII

Leo Edwards, Area Director, Region III

Deborah Gabry, Directorate of Technical Support and Emergency Management

Thomas Galassi, Director, Directorate of Technical Support and Emergency
Management

Eric Kampert, Office of Maritime, Directorate of Enforcement Programs

Patrick Kapust, Deputy Director, Directorate of Enforcement Programs

John King, Office of Maritime Compliance

Jim Maddux, Deputy Director, Office of Maritime Standards

Stacey McGuire, Desk Officer, Directorate of Standards and Guidance

Katie Nishimura, Compliance Officer, Region I

Joe Pedragon, Compliance Officer, Region IX

Bill Perry, Deputy Director, Directorate of Standards and Guidance

John Vos, Compliance Officer, Region IV

Ira Wainless, Office of Maritime Standards

Chairman Thornton took roll call of the Committee, and afterwards the
public introduced themselves.  The Committee discussed the minutes from
the previous meeting held in Newport News, on September 2, 2009 and
found that Chuck Lemon’s name had been omitted from the list of
Committee members in attendance.  The Committee unanimously approved the
minutes on the condition that Chuck Lemon’s name is added to the
minutes.  The corrected meeting minutes approved by the Committee were
entered into the record under Docket OSHA-2010-0001 as Exhibit 1.
Chairman Thornton also gave a summary of the meeting agenda.

Opening Remarks

Bill Perry, Deputy Director

 Directorate of Standards and Guidance

Mr. Perry welcomed the Committee, and told the Committee that he enjoyed
serving as the previous Designated Federal Officer.  Mr. Perry talked
about the Agency’s rejuvenated regulatory agenda, and directed them to
the Office of Management and Budget’s (OMB) web site, if they wanted
to see the two OSHA items under OMB review.   The first proposed OSHA
item is to reinstate the musculoskeletal disorders (MSD) column on the
OSHA recordkeeping form, so that employers can identify which recordable
injuries represent MSDs.  OSHA is hoping that by having the column on
the form, it will provide the Agency and the public with better
information on the occurrence of recordable MSDs in different industry
sectors.  The other item under review at OMB is the proposed rule to
revise Subpart D, Walking and Working Surfaces for General Industry, and
Subpart I, Personal Protective Equipment.  The proposed rule will
address slips, trips, and fall hazards, and will cover ladders, rope
descent systems, stairs, ramps, personal fall protection systems, and
things of that nature.  The proposed publication date is in March 2010.

Several proposed rules will become final rules this year.  Subpart F,
General Working Conditions in Shipyard Employment, is scheduled for
publication in September 2010and contains provisions for lockout/tagout
programs.  In July 2010, the Agency will issue a proposed rule for
crystalline silica exposure in general industry, construction, and
maritime industries.  OSHA is evaluating the comments from the peer
review.  OSHA is also working on the technological feasibility, the
economic analysis, and all the other parts of the proposed rule in order
to get it out this year.

	Other OSHA efforts include:

Hazard communication.  OSHA published a proposal to adopt the globally
harmonized system for hazard communication, including material safety
data sheets and labels.  The proposed rule has very broad application
and will affect almost every industry.  OSHA will hold a public hearing
in Washington, DC, on March 2, 2010.

Hexavalent chromium.  In response to a court remand, OSHA intends to
publish a final action for hexavalent chromium in February that will
deal with employee notification of monitoring requirements.

Combustible dust -- Last fall OSHA published an ANPR on combustible dust
hazards.  Although the record is technically closed, OSHA continues to
solicit useful information and data that would assist in the efforts to
fully understand the effects of a combustible dust standard in the
maritime industry.  The agency held stakeholder meetings in Washington,
D.C. in December and will hold another round of stakeholder meetings in
Atlanta in February, and another one in Chicago in April.

Chairman Thornton asked if the aforementioned standards projects
mentioned were the only standards on the regulatory agenda or if they
were just those that were of particular interest to the maritime
industry.  Mr. Perry explained that he just covered the ones that were
of greatest interest to the group.  Mr. Perry also stated that OSHA has
a number of other initiatives on the regulatory agenda such as
beryllium, which is a large health standard in its early stage.  In
addition, the record in the cranes and derricks rulemaking is now closed
and a final rule is being prepared.  Chairman Thornton also inquired
about the health management standard.  Mr. Perry informed the group that
the standard is not on the regulatory agenda although the new Assistant
Secretary is interested in promoting the growth of safety and health
management systems in general.

A member of the public asked Mr. Perry if the agency was going to issue
any regulations on hand-arm vibration and whole-body vibration.  Mr.
Perry informed the audience member that the agency is aware of the
hazard and OSHA believes the issue is very important, but OSHA does not
have any plans to develop or take any regulatory action on the issue.

Remarks

Amy Wangdahl,

MACOSH Webpage

Mrs. Wangdahl provided a brief update on the history of the MACOSH web
site.  In 2009 the Committee recommended that OSHA create a web site for
the Committee’s use that would house MACOSH documents and post meeting
information.  Although the web site is not yet accessible by Committee
members, Mrs. Wangdahl showed the Committee what the web site will look
like when it is fully functional.  She also informed the Committee that
this was the first time the agency has allowed a public group to access
an OSHA extranet site.

OSHA created three pages:  a general MACOSH page, a longshoring
workgroup page, and a shipyard workgroup page.  Committee members will
be able to access meeting information, minutes, MACOSH charter, contact
information, and completed projects on the general MACOSH page.  The
workgroup pages will be accessible only to workgroup members and will
contain priority lists, working documents, and workgroup contact
information.  The site is set up to be read-only, so only OSHA staff may
post documents.  Committee members may ask OSHA employees to initiate a
posting for them.  The returning MACOSH members on the next charter will
not have to re-register to use the web site.

Mrs. Wangdahl encouraged the Committee to suggest changes or
improvements at any time.  Chairman Thornton asked how the members are
to be informed when something has been added or updated.  Mrs. Wangdahl
stated that there is no automatic update message.  Several members
suggested everything to do with MACOSH should be posted on the page,
including MACOSH minutes from previous years.  Chairman Thornton thanked
Mrs. Wangdahl for her efforts.  The PowerPoint presentation entitled
“MACOSH Extranet Page” was entered into the record under Docket
OSHA-2010-0001 as Exhibit 2.

Remarks

David Michaels, Ph.D., MPH

Assistant Secretary for Occupational Safety and Health

The Committee members introduced themselves to Dr. David Michaels, the
newly appointed Assistant Secretary for Occupational Safety and Health.
Next, Chairman Thornton gave Dr. Michaels a brief summation of the
Committee’s successes since the beginning of the charter.

Dr. Michaels formally thanked the Committee for their hard work and
informed the Committee that he had been briefed extensively on the
success of the Committee.   He also stated that the important work the
Committee allows OSHA to help employers and workers around the country
prevent injuries and illnesses.  Dr. Michaels recognized Dr. Jennifer
Lincoln, a fellow epidemiologist on the Committee, and followed up by
providing the Committee with a brief background of his career prior to
arriving at OSHA.   He then discussed a few of OSHA’s activities.

This Administration is focused on enforcement.  OSHA inspectors are
issuing higher citations.  In fact, OSHA issued the biggest fine in its
history, $84 million, against BP.   For the most part, the Agency is not
interested in issuing bigger fines, but would like to work with
employers, unions, other groups to reduce injuries and illnesses.

The Agency is spending a lot of time thinking about regulations and how
to move them forward, which is something of concern to the Committee.
OSHA has some regulations in the pipeline that will hopefully to come
out soon.

OSHA will be holding a public meeting, “OSHA Listens,” at DOL
Headquarters on February 10, 2010.  Dr. Michaels invited the Committee
members and their colleagues to make an oral presentation at the meeting
or submit their written comments to OSHA.  Written comments will be
posted in the public docket.

Dr. Michaels affirmed his commitment to re-charter the Committee.
Finally, in response to a question about his priorities, he explained
that he will focus on enforcement, being strategic about the regulatory
process, exploring a safety and health program standard, and improving
recordkeeping.  He also emphasized the importance of the Agency’s
Voluntary Protection Program.

Shipyard Workgroup

Donald V. Raffo

Workgroup Leader

Mr. Raffo discussed the following top priorities of the Shipyard
Workgroup, which were determined at the September 2, 2009, meeting, and
their status.

Related Employment – The workgroup developed a white paper, which had
been distributed to the full Committee, listing job tasks that are
outside the scope of 1915 but are performed in shipyards.  The workgroup
considers these tasks to be related to shipyard employment.  The
Longshoring Workgroup did not recommend any changes to the document.
The Committee unanimously voted in favor of accepting the document.  The
white paper entitled “Shipyard Related Employment” was entered into
the record under Docket OSHA-2010-0001 as Exhibit 3.

SHIPS Rigging Document – The document was reviewed by the Shipyard
Workgroup, which recommended some changes.  OSHA incorporated the
changes, and the document was given to the Longshoring Workgroup for
review.  The Longshoring Workgroup did not recommend any changes.  The
Committee voted to accept was motion for the Committee to accept the
document and recommend that OSHA publish it.  The SHIPS document
entitled “Rigging” was entered into the record under Docket
OSHA-2010-0001 as Exhibit 4.

Commercial Fishing – The workgroup is currently working on and has
decided to draft two draft fact sheets.  One is on confined space safety
and it is approximately 90 to 95 percent complete.  The goal is to
submit the document to the Longshoring Workgroup for their review and to
incorporate their recommendations in time for a vote at the next
meeting.  The second fact sheet is on fall protection.  This fact sheet
is directed at the commercial fisheries operations, and vessel captains
or masters are the target audience.

Arc-flash Safety -- The workgroup is working on an arc-flash safety
document to incorporate into the upcoming SHIPS document on electrical
safety.  This issue is timely because bigger ships are starting to
switch over to electric systems.   The document will include specific
hazards and abatement recommendations.

Scaffolding and Cranes – The workgroup has been conducting a review of
29 CFR 1915.71 (the shipyard employment standard for scaffolds or
staging) and 29 CFR 1926.550(g) (the construction standard for crane or
derrick suspended personnel platforms).  This review will help MACOSH to
develop a standard that is unique to the industry.  Several members of
the Committee echoed the workgroup chairman’s statement that the
maritime industry should have had input during the negotiated rulemaking
on cranes and derricks in construction.  Although the hazards appear to
be the same between the industries, the feasible approaches to
controlling the hazards are different, especially with regard to safely
lifting workers.  The workgroup would like to have one set of maritime
standards rather than multiple industry standards that require shipyard
employers to determine which one applies where.  It is the Committee’s
goal to submit to OSHA, before the current charter ends, an advisory of
the need for a shipyard-specific standard.

BLS Data – The workgroup wanted to ensure they were looking in the
proper work areas to see where the injuries and fatalities were in the
maritime industry.  The workgroup has tasked one of its members with
developing a one-page white paper on BLS statistics on injuries in
shipyard employment and how the information could be useful or not to
the Committee.

Fact Sheets -- OSHA presented the Shipyard Workgroup with two fact
sheets:  one on ventilation during hot work and one on eye protection
against radiant energy while welding.  The workgroup provided
recommendations to OSHA.  The Agency is going to take the comments,
incorporate them into the fact sheets, and send the fact sheets out
again for review and comment.  The Longshoring Workgroup should have
reviewed it by the next meeting.

Silica – The workgroup took note that OSHA requested comments from the
Committee concerning silica in the shipyard industry.  Shipyards have
shifted away from using silica.  There were some questions on blasting
silica used in non-skid.  Silica is found in concrete, not in
traditional shipyard activities. Chairman Thornton solicited comments
from the audience about the use of silica, but no one responded.

Combustible dust – The workgroup heard two presentations on
combustible dust.  OSHA gave a short presentation on efforts to develop
a standard for this hazard.  Mr. Greg Grondin from Bath Iron Works
provided the workgroup with an extensive presentation on the issues of
combustible dust in the shipyard and some issues associated with the
current testing methods.  The PowerPoint presentation entitled
“Combustible Dust, An Old, New Hazard” was entered into the record
under Docket OSHA-2010-0001 as Exhibit 5.  The “MACOSH Shipyard
Workgroup Summary” was entered into the record as Exhibit 6.

Remarks

Ms. Janice Windau, Epidemiologist

Bureau of Labor Statistics

BLS Injury  and Fatality Data Discussion

Ms. Windau discussed how BLS collects their fatality data from the BLS
census of fatal occupational injuries.  It covers all work-related
injury fatalities that occur in the U.S., and it includes the 200-mile
offshore economic zone.  It includes the self-employed, public sector,
private sector, all industries, and volunteer workers.  The preliminary
data come out in August after the reference year, then there’s a
one-time update, with the final data being released in April of the next
year.

The fatality data are collected by the state; BLS also uses data from
several federal agencies including OSHA.  Non-fatal data comes from the
Survey of Occupational Injuries and Illnesses.  Up until 2010, the
survey was limited to private sector, State and local government in
about 25 or 30 States.  Starting with 2008 data BLS is collecting State
and local government nationwide.  An audience member asked if the survey
covered Federal employees and would it exclude Navy shipyards.  Ms.
Windau responded that BLS is working on getting data from the federal
government, and it would include civilian workers, but when it comes to
military workers, she’s didn’t believe so.  She explained that the
survey is mandatory except for some State and local governments.  State
Plan States are required to report, but whether non-State Plan States
report depends on state law.  BLS is currently using the North American
Industry Classification System, the 2002 edition, beginning with data
for 2003 and the Standard Occupational Classification System for
occupation, the 2000 version, beginning with 2003 data, and is now
beginning to use the 2007 NAICS to classify occupations.

The case characteristic data is in accordance with the BLS-developed
Occupational Injury and Illness Classification System (OIICS).  The
system covers nature of injury, the part of the body that was affected,
the event or exposure that describes what type of incident it was, the
source of injury, and the secondary source is what other type of
equipment was involved.  The OIICS is currently being revised and there
should be draft available in the spring.  Ms. Windau clarified that all
non-fatal data is extracted from the OSHA 300 log.

Ms. Windau told the Committee to get requests to her as soon as
possible, if they had any suggestions or would like additional breakouts
for the BLS case characteristics data on type of incidents, or type of
equipment, so BLS could to incorporate them into the OIICS draft.  Ms.
Windau explained the various data and charts in her presentation.  She
told the Committee how the data is sorted; how the injury and fatality
data can be sorted; and how it is categorized. There was a lengthy
discussion between Ms. Windau and the Committee on how to decipher the
data.  Ms. Windau concluded her presentation, and the PowerPoint
presentation entitled “BLS Data for Occupational Injuries and
Illnesses” was entered into the record under Docket OSHA-2010-0001 as
Exhibit 7.  The multi-page chart, “Number and Rate of Non Fatal
Occupational Injuries and Illnesses by Selected Industries, All U.S.,
Private Industry 2008,” was entered into the record as Exhibit 8.

Remarks

Mr. Kapust

MACOSH:  OSHA Enforcement Update, January 2010

Mr. Kapust gave a brief overview of OSHA’s inspection targeting
system, enforcement directives, maritime projects, and OSHA's inspection
statistics to include maritime in general industry.

Enhanced Enforcement Program (EEP) – The EEP is going to be replaced
by the Serious Violator Enforcement Program (SVEP).  The SVEP program
should be implemented soon and will focus OSHA’s resources on
employers who have demonstrated indifference to their obligations under
the OSH Act by committing willful repeat violations or failure to abate
violations in the most severe occupational hazards.  If an employer
meets the SVEP criteria, they will be subject to follow-up inspections
and additional actions.

Site-Specific Targeting 09 (SST) – This program became effective July
2009 and is based on 2007 injury and illness data where 80,000
establishments were surveyed.  It targets establishments with high days
away from work.

Lead National Emphasis Programs (NEP) -- The lead NEP has been active
since 2001 and was updated in 2008.  OSHA is using blood levels reported
by local health departments and targets industries  such as painting,
battery manufacturing, and scrap metal.

Silica NEP – This NEP has been active since 1996 and was updated in
early 2008.  It targets industries such as stonework, masonry, concrete,
iron foundries, process safety management, and oil refineries.

Refinery NEP -- Effective in August 2009, this NEP allows OSHA to
continue oil refinery inspections to completion by 2011.

Process Safety Management in Chemical Plants NEP – This NEP became
effective in July 2009 as a one-year pilot in Regions 1, 7, and 10.  It
targets PSM-covered chemical facilities, not refineries.  Businesses are
still subject to unprogrammed inspections in any region.  OSHA’s CSHOs
go on inspections with a list of 10 to 15 questions that will change
over time.  The CSHOs will ask these questions and if the CSHO believes
that there are deficiencies, they will expand the inspection.  At the
end of the pilot, OSHA is going to conduct a review and evaluate its
effectiveness and whether or not OSHA should expand and increase the
NEP’s length.

Federal Targeting (FedTarg) -- This targeting of Federal agencies began
in 2008 and is based on a Government Accounting Office study that
recommended targeting Federal workplaces.

Amputation NEP – This NEP has been in effect for three years and
targets 40 manufacturing standard industrial classifications with high
amputation rates, and high numbers of OSHA violations related to
amputations. OSHA is currently finalizing the evaluation of this
emphasis program.

Shipbreaking NEP – OSHA conducts about 40 inspections annually that
include Navy and private companies.  OSHA is conducting a five-year
review of this NEP.

Combustible Dust NEP – This NEP targets 64 industries with high
incidents of dust explosion or dust incidents that could cause
explosions.  Since October 2007, OSHA has conducted over 1,000 Federal
and State inspections with over 5,000 violations related to the NEP.
OSHA has issued a statistics report which can be found on the OSHA web
site.

NEPs Under Development – These include primary metals, exposures to
noise, silica, and lead.

Isocyanides –OSHA is looking at exposure to isocyanides in building
and construction to see how exposed workers can be targeted.

Hexachrome – Expected to be out soon and a targets industry with past
overexposures to hexachrome including welding, blasting, does include
shipbuilding and repair, and paint manufacturing.

The H1N1 Directive – Issued in November 2009, it follows CDC's
guidelines on infection control of H1N1 in high to very high hazard
health care settings.

Flavoring Chemicals NEP – This NEP was signed in October 2009 and was
designed to reduce exposures to flavoring chemicals in facilities that
manufacture food flavoring containing diacetyl.

Personal Protective Equipment -- will reflect the changes in the
personal protective and census standard that was recently updated to
include provisions for employer payment for PPE.

Asbestos – OSHA is updating the 1996 Compliance directive for 1926.
1910 and 1915 will be updated once the 1926 directive is complete.

Field Operations Manual (FOM) --  The FOM constitutes OSHA's general
enforcement policy and procedures for conducting inspections, issuing
citations, and proposing penalties, etc.  It became effective in March
2009 and was recently updated in November of 2009.  There will be
periodic updates.

Jurisdiction directive – Recently signed, it combines the OSHA/Coast
Guard Authority over Vessels Directive and the Outer Continental Shelf
Directive into a single document.

Mr. Kapust’s PowerPoint presentation entitled "MACOSH--OSHA
Enforcement Update January 2010" was entered into Docket OSHA-2010-0001
as Exhibit 9.

Shipyard Workgroup

Marc MacDonald

Workgroup Leader

Mr. MacDonald reported on the workgroups top priorities, determined at
the September 2, 2009, meeting and their status.

Combustible Dust – After OSHA’s presentation, the workgroup has a
good understanding of OSHA’s intent.  There is some overlap with
longshore marine cargo handling on the bulk products, but the workgroup
will make sure that that information gets back to their industry members
for possible comment.

Intermodal Container Repair Guidance Document -- Chuck Lemon lead the
development of the draft document.  The workgroup discussed and refined
the document, which was then given to the Shipyard Workgroup for review
and comment.  Some of the recommendations the Shipyard Workgroup
provided were considered and incorporated into the document, which Mr.
MacDonald described.  The Committee approved the guidance document for
the intermodal container repair safety and recommended that OSHA publish
it as a guidance document.  The document entitled “Guidance Document
for the Safety of Workers Involved in Intermodal Container Repair” was
entered into the record at Docket OSHA-2010-0001 as Exhibit 10.

Traffic Lane and Personal Safety Zone Guidance Document – In the
absence of any OSHA regulations on traffic lanes and safety zones in
marine terminals, the workgroup collected measurements of terminal
safety zones throughout the country and found huge variations between
the safety lanes and safety zones in the terminals.  Most of the lanes
measured 8 feet and there was enough space for a truck and chassis to
pass through the lanes, but not enough space for a bomb cart or basket
chassis with flanges extending from either side.  The workgroup
developed performance-based language for safety zones to protect people
working on the highline or the apron under the crane.  The shipyard
workgroup has reviewed the document and has not recommended changes.
The Committee voted in favor of accepting the document and recommending
that OSHA publish the document as a guidance document.  The document
entitled "Guidance Document for Traffic Lane and Personnel Safety Zones"
was entered into the record under Docket OSHA-2010-0001 as Exhibit 11.

Working on the Apron or Highline Quick Card – The document is
complete, but the Shipyard workgroup has not reviewed it, so it cannot
be put before the Committee for a vote.  The quick card could be used
during gangway safety meetings.  The Committee will have the document
ready for a vote at the next MACOSH meeting.  The document entitled,
"Working on the Apron or Highline in Marine Terminals" was entered into
the record at Docket OSHA-2010-0001 as Exhibit 12.

Break Bulk Guidance Document – The break bulk cargo-handling safety
document was turned over to OSHA at the previous MACOSH meeting.  OSHA
asked the workgroup to review some photos to go into the document.  The
Committee picked the best available photos on the condition that OSHA
crop the pictures that showed possible violations.  OSHA has requested
additional pictures, and the workgroup has agreed provide them.

Container Rail Safety Guidance -- The workgroup is working on a complex
container rail safety guidance document.  Much work needs to be done to
the document, and the workgroup is hoping to have it before the full
Committee by the next MACOSH meeting.

Speed in Terminals -- The workgroup discussed the white paper and made
some observations on corrections.  The scope and the intent were
discussed, and there were different options on how to proceed with the
paper, which Mr. Favazza read into the record.  There was a lengthy
discussion on this issue and the Committee decided to go back to the
table with the issue and try to incorporate some language into the
existing Traffic Safety in Marine Terminals document.  The document
entitled “Speedometers in Haulage Equipment on Marine Terminals” was
entered into Docket OSHA-2010-0001 as Exhibit 14.

Stuck Cones -- Semi-automatic twist locks are used to attach stacked
containers to each other; they have some moving parts (cones) that can
become stuck.  The issue is how to get someone on top of a container
safely to access the stuck cone, and then how to make sure that that
person is not in the bight when the container is released.  The
workgroup is going to continue their work on this document.

The Committee voted in favor of accepting the workgroup report.  The
PowerPoint presentation entitled “Longshore Workgroup Report,
1-20-2010” was entered into Docket OSHA-2010-0001 as Exhibit 13.

Remarks

Debbie Gabry

Directorate, Science Technology and Emergency Management

OSHA has updated five new longshoring and marine terminal abatement
summaries.  OSHA changed the title to Longshoring and Marine Terminal
Fatal Facts.  The information comes from OSHA case files.  It talks
about the incident, references OSHA standards, and provides control
measures that will help alleviate accidents.  Once the document has been
cleared by the Assistant Secretary, it will be put up on OSHA’s web
site.

Ending Remarks

Chairman Thornton announced that Pat Strickland is retiring, and he
introduced the Committee’s new travel coordinator, Christie Garner.
He also informed the Committee of his plans to write OSHA’s Assistant
Secretary about rechartering the Committee.

At 3:23 p.m. – Meeting adjourned

I hereby certify that, to the best of my knowledge, the foregoing
minutes are accurate and complete.

		___________________________________________

		James Thornton, Chairman

		Maritime Advisory Committee for Occupational Safety and Health

These minutes will be formally considered by the Committee at its next
meeting, and any corrections or notations will be incorporated in the
minutes of that meeting.

 PAGE

 PAGE   10


[Federal Register Volume 87, Number 19 (Friday, January 28, 2022)]
[Notices]
[Pages 4607-4609]
[FR Doc No: 2022-01796]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-5225]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Foreign Supplier Verification Programs for Food
Importers

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
requirements associated with our Foreign Supplier Verification Programs
for Food Importers.

DATES: Submit either electronic or written comments on the collection
of information by March 29, 2022.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before March 29, 2022. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of March 29, 2022. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-D-5225 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Foreign Supplier Verification
Programs for Food Importers.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS

CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including
the claimed confidential information, in its consideration of comments.
The second copy, which will have the claimed confidential information
redacted/blacked out, will be available for public viewing and posted
on https://www.regulations.gov. Submit both copies to the Dockets
Management Staff. If you do not wish your name and contact information
to be made publicly available, you can provide this information on the
cover sheet and not in the body of your comments and you must identify
this information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Foreign Supplier Verification Programs (FSVP) for Food Importers--21
CFR Part 1, Subpart L

OMB Control Number 0910-0752--Extension

    This information collection supports FDA regulations in 21 CFR part
1, subpart L (21 CFR 1.500 through 1.514), which help to implement
section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 384a). Section 805 authorizes the Agency's FSVP and establishes
requirements applicable to imported food. Respondents to the
information collection are importers, as defined in section 805(a)(1)
of the FD&C Act. The regulations are intended to provide verification
that imported food is produced in compliance with statutory
requirements that include the implementation of appropriate risk-based
preventive controls. The regulations also establish that importers of
foods must develop, maintain, and follow an FSVP that provides adequate
assurances a foreign supplier is producing the food in compliance with
processes and procedures that provide at least the same level of public
health protection as those required under section 418 of the FD&C Act
(21 U.S.C. 350g) (regarding hazard analysis and risk-based preventive
controls for certain foods) or 419 (21 U.S.C. 350h) (regarding
standards for produce safety), if either is applicable, and the
implementing regulations, and is producing the food in compliance with
sections 402 (21 U.S.C. 342) (regarding adulteration) and 403(w) (21
U.S.C. 343(w)) (if applicable) (regarding misbranding with respect to
labeling for the presence of major food allergens) of the FD&C Act. The
regulations also provide for certain exemptions. To assist respondents
with understanding the requirements we have developed Agency guidance,
available at: https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals.
    Specifically, regulations in 21 CFR 1.501 set forth the
applicability of requirements for FSVP, while regulations in sections
1.502 through 1.508, prescribe specific activities for developing,
maintaining, and following an FSVP; as well as for evaluating
compliance and for identifying and correcting hazards. Finally,
regulations in section 1.509 identify required data elements applicable
to food products offered for importation into the United States, while
regulations in 1.510 govern required records, providing that records be
made available to FDA upon request and that records be maintained
electronically. On May 10, 2021, FDA launched the FSVP Importer Portal
for FSVP Records Submission as a means for importers to upload FSVP
records electronically and submit them to the Agency, after receiving a
request for records from FDA. The portal may be found at https://www.access.fda.gov/, and a user guide is available at https://www.fda.gov/media/148312/download.
    We estimate the burden for the information collection as follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
               21 CFR section                    Number of     responses per   Total annual          Average  burden per  response          Total hours
                                                respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Exemption for food for research; 1.501(c)...          36,360              40       1,454,400  0.083 (5 minutes).........................         120,715
Identifier for filing with U.S. Customs and           56,800             157       8,917,600  0.02 (1.2 minutes)........................         178,352
 Border Protection; 1.509.
                                             -----------------------------------------------------------------------------------------------------------

    Total...................................  ..............  ..............      10,372,000  ..........................................         299,067
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with the information collection.

                                                 Table 2--Estimated Annual Recordkeeping Burden \1\ \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
   Information collection activity; 21 CFR       Number of      records per    Total annual        Average burden per recordkeeping         Total hours
                   section                     recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Controls for low-acid canned foods; 1.502(b)           2,443               4           9,772  1.........................................           9,772
Hazard determinations, controls, and audits;          56,800           87.74       4,984,036  0.38 (23 minutes).........................       1,917,174
 1.504, 1.506, 1.511.
Written assurances for food produced under            11,701            2.88          33,664  2.25......................................          75,744
 dietary supplement current good
 manufacturing practices; 1.511.
Document very small importer/certain small            50,450               1          50,450  1.........................................          50,450
 foreign supplier status; 1.512(b)(1).
Written assurances associated with very               50,450            2.79         141,084  2.25......................................         317,439
 small importer/certain small foreign
 supplier; 1.512(b)(3).
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............       5,219,006  ..........................................       2,370,579
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with the information collection.
\2\ Figures have been rounded to the nearest one hundredth.

    Upon evaluation of the information collection, we are retaining the
currently approved burden estimates.

    Dated: January 24, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-01796 Filed 1-27-22; 8:45 am]
BILLING CODE 4164-01-P


REVISED TECHNICAL SUPPORT DOCUMENT FOR COKE CALCINERS: SUPPLEMENTAL PROPOSED RULE FOR THE GREENHOUSE GAS REPORTING PROGRAM

                                                    Office of Air and Radiation
                                           U.S. Environmental Protection Agency

                                                                  April 1, 2023
                                   CONTENTS

1.  Industry Description	1
2.  Total Emissions	2
3.  Review of Existing Programs and Methodologies	3
3.1  Review of Existing Programs	3
3.2  Calculation Methodologies for Coke Calcining Processes	4
4.  Options for Reporting Threshold	6
5.  Options for Monitoring Methods	7
5.1  CEMS Method	7
5.2  Mass Balance and Combustion Methods	7
6.  QA/QC Requirements	8
7.  Options for Estimating Missing Data	8
8.  References	9

1.  Industry Description

The coke calciner source category consists of processes that heat petroleum coke to high temperatures in the absence of air or oxygen for the purpose of removing impurities or volatile substances in the petroleum coke feedstock. The coke calciner source category includes, but is not limited to, rotary kilns or rotary hearth furnaces used to calcine petroleum coke.

Calcined petroleum coke is a nearly pure carbon material used primarily to make anodes for the aluminum, steel, and titanium smelting industries. The aluminum industry accounts for nearly 75 percent of the world's calcined coke consumption.

Table 1 includes a list of the coke calcining facilities based on available information (BP, 2008; company [Oxbow and Rain Industries] websites; and Louisiana Department of Environmental Quality, Electronic Document Management System (https://edms.deq.louisiana.gov/edmsv2/quick-search). There are an estimated 5 operating coke calcining companies in the US with 15 currently operating facilities with 29 coke calcining process units. Most coke calcining facilities are located at or near a petroleum refinery. Oxbow is the largest supplier of calcined petroleum coke in the world, with worldwide production capacity of 2.34 million tons/year and US production capacity of 1.9 million tons/year (Calcining (oxbow.com)). Rain Industries is also a significant producer of calcined petroleum coke, with worldwide production capacity of 2.1 million tons/year and estimated US production capacity of approximately 1.8 million tons/yr. (Carbon | Rain Industries Limited (rain-industries.com)).
Table 1. US Coke Calcining Facilities.
                                   Facility
                                   Location
                                   Calciner
                            Capacity[†] (tons/yr)
BP Cherry Point - #3
Blaine, WA
1 rotary hearth

BP Cherry Point - #1 & 2
Blaine, WA
2 rotary hearths

Marathon (formerly BP) Wilmington
Carson, CA
1 rotary kiln

RAINCII-Robinson
Robinson, IL
2 rotary kilns
                                                                        315,000
RAINCII-Lk Charles
Lake Charles, LA
2 rotary kilns
                                                                        350,000
RAINCII (ex-CII CARBON)
Moundsville, WV
2 rotary kilns
                                                                         closed
RAINCII-Norco
Norco, LA
1 rotary kiln
                                                                        400,000
RAINCII-Gramercy
Gramercy, LA
1 rotary kiln
                                                                        400,000
RAINCII-Chalmette
Chalmette, LA
1 rotary kiln
                                                                        400,000
RAINCII-Purvis
Purvis, MS
1 rotary kiln

Seadrift
Port Lavaca, TX
1 rotary kiln

ConocoPhillips-Santa Maria
Santa Maria, CA
1 rotary kiln
                                                                         closed
ConocoPhillips-Contra Costa
Rodeo, CA
2 rotary kilns

ConocoPhillips Lake Charles
Lake Charles, LA
1 rotary kiln

Oxbow-Lemont (formerly Chicago Carbon Company)
Lemont, IL
2 rotary kilns
                                                   Production suspended in 2020
Oxbow-Port Arthur A
Port Arthur, TX
3 rotary kilns
                                                                        700,000
Oxbow-Port Arthur B
Port Arthur, TX
1 rotary kiln

Oxbow-Enid
Enid, OK
3 rotary kilns
                                                                        500,000
Oxbow-Baton Rouge
Baton Rouge, LA
4 rotary kilns
                                                                        700,000
  [†]	Based on company website or Title V air permit.

2.  Total Emissions

Conventional fuels are generally only used during startup to get the calcining kiln (or furnace) up to the desired operating temperature. Once the desired calcining temperature is reached, process gas consisting of volatile organics and sulfur-containing compounds driven from the coke are used as the primary fuel to maintain kiln temperatures (see Figure 1). An afterburner is used to convert excess process gas to carbon dioxide (CO2) and sulfur dioxide (SO2); a waste heat boiler may be used to recover energy from this combustion process. The afterburner off-gas is emitted to the atmosphere and is the primary source of greenhouse gas (GHG) emissions from this process. The primary GHG emissions are CO2 emissions; the afterburner will also likely release trace amounts of methane (CH4) and nitrous oxide (N2O) like other stationary combustion devices.

Figure 1. Illustration of rotary hearth coke calcining process (from BP, 2008).

Many coke calcining facilities report to the Greenhouse Gas Reporting Program (GHGRP; 40 CFR part 98). Coke calcining process units co-located at petroleum refineries must calculate and report emission from coke calciners following the methodologies specified in GHGRP Subpart Y  -  Petroleum Refineries. Other facilities either do not report or report coke calciner emissions as petroleum coke combustion under GHGRP Subpart C - Stationary Combustion Sources. Based on data reported to the GHGRP for Reporting Year (RY) 2019, the typical coke calcining facility emits 150,000 metric tons (mt) CO2 per year. With 15 operating facilities in the US, it is estimated that these facilities emit 2.2 million mt CO2 per year. As an alternative method to project national coke calcining emissions, it is estimated that coke calcining capacity in the US is about 5-million tons per year. Assuming 10 percent of the petroleum coke fed to the unit is consumed during the coke calcining process, national emissions from coke calciners are estimated to be 1.8 million mt CO2 per year.

Because coke calciners are primarily a CO2 emission source, the coke calciner source category was not significantly impacted by the revisions to the global warming potentials of CH4 and N2O, as discussed in this supplemental proposal.

3.  Review of Existing Programs and Methodologies

3.1  Review of Existing Programs
In developing GHG monitoring and reporting options for coke calcining process units, several existing programs and guideline methodologies were reviewed.  Specifically, the following resources were examined:

 2006 Intergovernmental Panel on Climate Change (IPCC) Guidelines for National Greenhouse Gas Inventories. Volume 2, Chapter 2. https://www.ipcc-nggip.iges.or.jp/public/2006gl/pdf/2_Volume2/V2_2_Ch2_Stationary_Combustion.pdf.

 European Union (EU) 2021.  Commission Implementing Regulation (EU) 2018/2066 of 19 December 2018 on the Monitoring and Reporting of Greenhouse Gas Emissions Pursuant to Directive 2003/87/EC of the European Parliament and of the Council and Amending Commission Regulation (EU) No. 601/2012. January. https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02018R2066-20210101&from=EN.

 International Aluminum Institute (IAI) 2006. The Aluminum Sector Greenhouse Gas Protocol. October. https://ghgprotocol.org/sites/default/files/aluminium_1.pdf.

 API (American Petroleum Institute) 2009. Compendium of Greenhouse Gas Emissions Methodologies for the Oil and Natural Gas Industry. August. https://www.api.org/~/media/Files/EHS/climate-change/2009_GHG_COMPENDIUM.pdf

 CARB (California Air Resource Board) 2019. Unofficial Electronic Version of the Regulation for the Mandatory Reporting of Greenhouse Gas Emissions. April. https://ww2.arb.ca.gov/sites/default/files/classic/cc/reporting/ghg-rep/regulation/mrr-2018-unofficial-2019-4-3.pdf

 Environment and Climate Change Canada (ECCC) 2020. Canada's Greenhouse Gas Quantification Requirements. Version 4.0. December. http://publications.gc.ca/collections/collection_2021/eccc/En81-28-2020-eng.pdf.

Each of these sources were reviewed to determine the types of emissions to be reported, the facility reporting thresholds, the calculation methodologies, and the monitoring methodologies recommended. The remainder of this section summarizes the key calculation methodologies. The reporting and monitoring options presented in Section 4 and Section 5 are consistent with the methodologies used in these existing programs and guidelines.

3.2  Calculation Methodologies for Coke Calciners
From the review of existing programs five basic calculation methodologies were identified. The calculation methods are presented in terms of their relative accuracy, from most to least accurate.

  Method 1.	CEMS Method. Measure CO2 concentration and total exhaust gas flow rate using a continuous emission monitoring system (CEMS) and calculate CO2 concentrations from these measured values using Equation C-6 and, if necessary, Equation C-7 of 40 CFR 98.33(a)(4).

  Method 2.	Carbon Balance Method. This is a mass balance method using the carbon content of the green and calcined coke. This method is based on the overall carbon balance approach in IAI (Equation 5, IAI, 2006) and is used in the ECCC requirements for petroleum refineries (Equation 11-22, ECCC, 2020). The equation as presented in ECCC is provided below. This equation is the same as Equation Y-13 of 40 CFR 98.253(g)(2) used for coke calcining process units co-located at petroleum refineries.

  Method 3.	Methane in Green Coke Method. The methane in green coke uses a fixed methane content in the coke of 0.035 mass fraction and uses mass reduction in the quantity of coke fed to the process (corrected for moisture, volatile, and sulfur content) and the quantity of coke leaving the process (corrected for sulfur content). This method is based on the coke calcining approach in IAI (Equation 6, IAI, 2006) and is used in the ECCC requirements for aluminum production (Equation 5-6, ECCC, 2020). The equation as presented in IAI is provided below.  It is expected that coke calcine operators could just as easily determine the carbon content of the green and calcined coke and use the more direct carbon balance method.

  Method 4.	Vapor Combustion Method. This method is recommended by API (2009) for coke calcining kilns (Table 2-9), although the method is presented specifically for incinerators, thermal oxidizers, and vapor combustion units (Section 4.7, API, 2009). The method relies on analysis of carbon content of the gas stream inlet to the vapor combustion unit. CO2 emissions are calculated assuming non-CO2 carbon is combusted and converted to CO2 at the efficiency of the combustion system, and assuming 100 percent of the CO2 in the inlet gas stream is emitted. The difficulty with applying this method for coke calciners is collecting representative samples of the process off-gas prior to the afterburner. There may be limited stack length prior to the afterburner and the process gases are very hot in a reducing atmosphere, so sampling between the process and afterburner is dangerous. Additionally, the process gas composition may be variable based on feedstock coke properties and calciner operating conditions, requiring frequent sampling to get representative concentrations.

  Method 5.	Coke Combustion Method. This method is based on the method that some non-refinery facilities report emissions from coke calcining operations under 40 CFR part 98, subpart C. This method can be applied using either the default high heat values and CO2 emission factors in Table C-1 for petroleum coke (Tier 1 or 2) or measured carbon content of the green coke (Tier 3) and attribute the mass reduction of coke as petroleum coke combusted. This method does not correct for the fact that the volatile matter has a lower carbon content than the green petroleum coke and so is likely to produce CO2 emission estimates that are biased high. However, this method is simple and relatively accurate.

4.  Options for Reporting Threshold

Four basic options were evaluated as potential reporting thresholds.

   Option 1.	All facilities with facility-wide GHG emissions exceeding 100,000 mt CO2e must report GHG emissions from coke calciners.
   Option 2.	All facilities with facility-wide GHG emissions exceeding 25,000 mt CO2e must report GHG emissions from coke calciners ("Table A-4" subpart).
   Option 3.	All facilities with facility-wide GHG emissions exceeding 10,000 mt CO2e must report GHG emissions from coke calciners.
   Option 4.	All facilities with coke calcining process units must report their GHG emissions from coke calciners ("all-in" or "Table A-3" subpart).

Table 2 presents the number of coke calcining facilities and their GHG emissions included for each threshold option. We expect all coke calcining facilities to have combined calcining and combustion emissions exceeding the 25,000 mt CO2e threshold. With the off-ramp provision in 40 CFR 98.2(i), there is limited difference between the threshold options.

Table 2.  Evaluation of Alternative Threshold Options (considering direct emissions only)
                            Option/Threshold Level
                               Emissions Covered
                              Facilities Covered

                                 mt CO2e/year
                                    Percent
                                    Number
                                    Percent
                                    100,000
                                   1,970,000
                                     98.5%
                                      14
                                      93%
                                    25,000
                                   2,000,000
                                     100%
                                      15
                                     100%
                                    10,000
                                   2,000,000
                                     100%
                                      15
                                     100%
                             All-in (no threshold)
                                   2,000,000
                                     100%
                                      15
                                     100%

5.  Options for Monitoring Methods

5.1  CEMS Method
The CEMS method uses direct measurement CO2 concentration and total exhaust gas flow rate, The CEMS monitoring requirements are outlined in 40 CFR 98.33(a)(4).

5.2  Mass Balance and Combustion Methods
All the non-CEMS methods require monitoring of mass quantities of green coke fed to the process, calcined coke leaving the process, and coke dust removed from the process by dust collection systems.

The mass quantities can be determined using commercial weighing equipment meeting selected accuracy requirements or can simply use company records. Generally, most facilities would follow the Specifications, Tolerances, and Other Technical Requirements For Weighing and Measuring Devices, NIST Handbook 44 (2022). Measurements made following NIST requirements are expected to be more accurate than measurements made not following NIST requirements.

The carbon balance method requires determination of carbon content of the green and calcined coke. The Tier 3 coke combustion method also requires determination of carbon content, but only for the green coke. The carbon content of the green and calcined coke is commonly determined via ultimate analysis of the coke. Suitable methods include:

 ASTM D3176-15 Standard Practice for Ultimate Analysis of Coal and Coke
 ASTM D5291-16 Standard Test Methods for Instrumental Determination of Carbon, Hydrogen, and Nitrogen in Petroleum Products and Lubricants.
 ASTM D5373-21 Standard Test Methods for Determination of Carbon, Hydrogen, and Nitrogen in Analysis Samples of Coal and Carbon in Analysis Samples of Coal and Coke.

It is expected that ultimate analyses composition will be available from purchase records of green coke and from routine monitoring of feed material and product quality analyses. The carbon content is not likely to vary significantly. These routine measurements are conducted to verify that the impurities levels in the coke are less than those specified for the green coke input or calcined coke product. The rule could specify a measurement frequency (weekly, monthly, quarterly, or annually). Typically, the more measurements conducted, the more accurate the average value will be. The methane in green coke method appears to require at least monthly measurements (although focused on the content of impurities rather than the carbon content) and applies the calculation monthly. The carbon balance method as implemented in subpart Y of the GHGRP only requires that an annual average carbon content be determined. This requirement could be met by a single annual analysis; however, it is expected that the annual average would be determined based on a much greater number of measurements that are routinely determined by the process operator.

The methane in green coke method requires proximate analysis of the coke to determine moisture, volatile matter, and ash content. This is generally accomplished using:

 ASTM D3172-13(2021): Standard Practice for Proximate Analysis of Coal and Coke.

The percent sulfur requires additional analysis of sulfur in the ash using one of the following methods.

 ASTM D3174-12 (Reapproved 2018): Standard Test Method for Ash in the Analysis Sample of Coal and Coke from Coal.
 ASTM D5016-16: Standard Test Method for Total Sulfur in Coal and Coke Combustion Residues Using a High-Temperature Tube Furnace Combustion Method with Infrared Absorption.
 ASTM D4239-18: Standard Test Method for Sulfur in the Analysis Sample of Coal and Coke Using High-Temperature Tube Furnace Combustion

As noted previously, the methane in green coke method requires these measurements at least monthly. It is expected that coke calcining process operators may conduct many of these analyses on a routine basis (more frequently than monthly).

There are a number of gas composition analysis methods available, such as those listed in 40 CFR 98.254(d). However, as noted in Section 3 of this document, collecting representative vapor samples of the coke calciner process off-gas prior to the afterburner is expected to be difficult and unsafe. Therefore, further review of gas compositional methods was not conducted.

6.  QA/QC Requirements

To ensure the quality of the reported GHG emissions, the following quality assurance/quality control (QA/QC) activities are considered important:
(1)	For coke mass measurements, calibrate the measurement device according to the procedures specified by NIST Handbook 44 or the procedures specified by the manufacturer. Recalibrate either biennially or at the minimum frequency specified by the manufacturer.
(2)	For coke carbon (or impurity) content measurements, follow approved analytical procedures and maintain and calibrate instruments used according to manufacturer's instructions. Document the procedures used to ensure the accuracy of the measurement devices used.
(3)	All CO2 CEMS and flow rate monitors used for direct measurement of GHG emissions should comply with QA procedures for daily calibration drift checks and quarterly or annual accuracy assessments, such as those provided in Appendix F to Part 60 or similar QA procedures.
7.  Options for Estimating Missing Data

A complete record of all measured parameters used in the GHG emissions calculations is required (e.g., concentrations and flow rates for the CEMS method and quantities of coke and carbon content values for mass balance or combustion methods). Whenever a quality-assured value of a required parameter is unavailable (e.g., if a CEMS malfunctions during unit operation or if a required fuel sample is not taken), a substitute data value for the missing parameter shall be used in the calculations.
In general, it is recommended that the average of the data measurements before and after the missing data period be used to calculate the emissions during the missing data period. If, for a particular parameter, no quality-assured data are available prior to the missing data incident, the substitute data value should be the first quality-assured value obtained after the missing data period. Missing data procedures are applicable for CEMS measurements, mass of coke measurements, and carbon content (or coke impurity) measurements.

8.  References

   2006 Intergovernmental Panel on Climate Change (IPCC) Guidelines for National Greenhouse Gas Inventories. Volume 2, Chapter 2. https://www.ipcc-nggip.iges.or.jp/public/2006gl/pdf/2_Volume2/V2_2_Ch2_Stationary_Combustion.pdf.

   British Petroleum (BP). 2008. NSPS Subpart J Applicability to BP Cherry Point Coke Calciner. Presentation by BP Cherry Point Refinery to US EPA, circa 2008.
   European Union (EU) 2021.  Commission Implementing Regulation (EU) 2018/2066 of 19 December 2018 on the Monitoring and Reporting of Greenhouse Gas Emissions Pursuant to Directive 2003/87/EC of the European Parliament and of the Council and Amending Commission Regulation (EU) No. 601/2012. January. https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02018R2066-20210101&from=EN.

   International Aluminum Institute (IAI) 2006. The Aluminum Sector Greenhouse Gas Protocol. October. https://ghgprotocol.org/sites/default/files/aluminium_1.pdf.

   API (American Petroleum Institute) 2009. Compendium of Greenhouse Gas Emissions Methodologies for the Oil and Natural Gas Industry. August. https://www.api.org/~/media/Files/EHS/climate-change/2009_GHG_COMPENDIUM.pdf

   CARB (California Air Resource Board) 2019. Unofficial Electronic Version of the Regulation for the Mandatory Reporting of Greenhouse Gas Emissions. April. https://ww2.arb.ca.gov/sites/default/files/classic/cc/reporting/ghg-rep/regulation/mrr-2018-unofficial-2019-4-3.pdf

   Environment and Climate Change Canada (ECCC) 2020. Canada's Greenhouse Gas Quantification Requirements. Version 4.0. December. http://publications.gc.ca/collections/collection_2021/eccc/En81-28-2020-eng.pdf.

   Butcher T, Harshman R, Konijnenburg J, Lee GD, Williams J, Warfield L, Benham E, Bowers S, and Lippa K (2022) Specifications, Tolerances, and Other Technical Requirements for Weighing and Measuring Devices. (National Institute of Standards and Technology, Gaithersburg, MD), NIST Handbook (HB) NIST HB 44-2023. https://doi.org/10.6028/NIST.HB.44-2023


Sent by<EMAIL_ADDRESS> Received Date:  07/24/2006 04:54 PM

Transmission Date:  07/24/2006 04:54:47 PM

To:  Michael Samulski/AA/USEPA/US@EPA

cc:

Subject:  SBREFA notes from Indmar

INDMAR CATALYTIC CONVERTER HISTORY

April 2002- Hired engineer for converter development

Spring 2003- Visited several automotive catalytic converter manufacturers

Summer 2003- Supplied two ski boats to Southwest Research Institute (SwRI) for

                         converter durability testing. Assisted with calibration development.

June 2003- Selected low volume automotive supplier to develop marine converter

                   system

Fall 2003- Extensive dyno testing to determine catalyst substrate size and shape for

                  minimum backpressure and optimum performance

Spring 2004- Determined insulation requirements for catalyst and precious metal

                      loading for best converter efficiencies

Summer 2004- SwRI completed 480 hours of durability on four boats with positive

                         results.

Fall 2004- Started production design with converter added to rear of exhaust manifold

May 2005- Built Indmar test boat with catalytic converters

June 2005- Hired additional engineer for exhaust manifold design and product integration

June 2005- SwRI started 480 hours of durability on three boats in salt water.

July 2005- Revised design from converter being added after exhaust manifold to

                  converter integrated into manifold

August 2005- Selected exhaust manifold design, tooling and production facility

September 2005- Indmar boat tested at GM Desert Proving Grounds and high

                            altitude facility

September 2005- Committed to June 2006 production on premium 5.7L engines (5000 engines first year)

December 2005- Indmar calibration boat tested in salt water (about 160 hours)

INDMAR CATALYTIC CONVERTER HISTORY

January 2006- Florida test trip with GM

February 2006- Showed production part at Miami Boat Show

February 2006- Florida test trip with GM

March 2006- MEFI 5A software buy-off trip

May 2006- Tested production parts in Phoenix hot weather and altitude

May 2006- Started salt water durability test boat (currently at 350 hours and problem free)

June 2006- Verified converter protection misfire program on dyno

July 2006- Emission values for CARB  1.81 HC, 2.03 NOx, 3.84 HC+NOx,  46.56 CO or 2.01 HC, 2.26 NOx, 4.27 HC+NOx, 51.82 CO with DF applied