By-Product Synergy / Industrial Symbiosis

Analysis of US and UK Models

Introduction

In the mid-1990s, a new industrial strategy based on emulating natural
processes to achieve 100 percent product was begun at a steel mill
outside of Dallas, Texas. In the years since, the by-product synergy
(BPS) approach has been implemented in eight regions across North
America and exported to the United Kingdom. Companies in China and
Portugal are in line to adopt the approach. While the process has
continued to evolve and grow in the United States, it has been slowed by
developmental, political, economic and other challenges. Meanwhile, in
the United Kingdom, it has flourished. More than 6,000 companies have
participated in the UK’s National Industrial Symbiosis Program (NISP),
producing hundreds of millions of dollars in audited savings and new
revenue, tremendous energy and environmental savings and hundreds of new
jobs.

Why has this approach worked so well in the UK?  What can be done to
carry the UK results back to the US to explore the potential here? Will
the next chapter in the evolution of this process be a merging of these
two programs to produce a powerful new hybrid? This paper is an analysis
of these two programs, their similarities, their differences, their
successes and failures, and the lessons and policy recommendations that
flow from them.

By-Product Synergy

In the US, by-product synergy has been defined as “the synergy among
diverse industries, agriculture, and communities resulting in profitable
conversion of by-products and wastes to resources promoting
sustainability.”  The process involves creating a legally protected
forum of 10 to 30 enterprises in which process- knowledgeable experts
can safely explore reuse opportunities. These opportunities can involve
materials, energy, people, transport and other resources.  As one BPS
participant put it, the process establishes “a culture of
possibilities.”  In this give-and-take context of information and
process knowledge, BPS establishes an active framework to examine the
possibilities of by-product reuse. The process generally progresses as
follows: commitment, awareness, data collection, analysis,
implementation, and evaluation.

The By-Product Synergy process was developed and field tested in the
mid-1990s by the Business Council for Sustainable Development for the
Gulf of Mexico, precursor to the United States Business Council for
Sustainable Development (US BCSD). During the past 10 years, it has been
applied with varying degrees of success in the United States, Mexico and
Canada involving several hundred companies and producing tens of
millions of dollars in savings and new revenues. Support for the process
continues to grow. The most recent project is under way in the Chicago
region, where it is being supported by more than 25 companies, along
with local, state and federal economic development and environmental
agencies.

Despite its potential benefits, the BPS concept can be a tough sell.
Competition among companies and concerns about confidentiality can
cripple synergy discussions, and environmental laws often favor disposal
over reuse. If BPS is to become widespread, industry must make reuse a
priority, and state and federal agencies must recognize and support
industry efforts.

Enter the United Kingdom

In 1999, the UK BCSD invited Andrew Mangan, executive director of the US
Business Council, to introduce the BPS process to companies operating in
England and Scotland. After several years of gestation, a BPS-based
process was launched in the West Midlands of Central England in 2003 as
the National Industrial Symbiosis Program (NISP), with the aid of $1
million from the regional economic development agency. By 2006, the
program had become national in scope, receiving $17 million per year in
funding from the UK Treasury and regional economic development agencies
and was returning results that regularly beat expectations making it one
of the most productive government programs on the books. In 2008, NISP
is expected to receive $32 million in government funding.

The funding increase is based on the returns the program has generated.
Between June 2005 and June 2006, NISP was responsible for the diversion
of more than 860,000 tons of waste from landfill sites across the UK. It
has also reduced carbon dioxide emissions by over one million tons and
the use of industrial water by 260 million liters. Peter Laybourn, the
program’s founder and director, was invited to testify before the
British House of Commons Environmental Audit Committee on the
program’s impressive results earlier this year and the European
Commission recently designated NISP as an exemplary environmental
program, the only program from the UK to receive this designation.

With this success, NISP is initiating more strategic regional planning
initiatives relating to climate change, energy efficiency and waste
reduction. As part of this growth plan, NISP is interested in
establishing a formal partnership with the US BCSD to share best
practices, skill sets, and project opportunities relating to by-product
synergy.

US BCSD By-Product Synergy

Methodology

The core of a successful by-product synergy project is the recruitment
of 10 to 30 companies and local government departments
(water/wastewater, streets, ports, etc.) Participants are asked to pay a
fee for the year-long process, usually between $5,000 and $15,000 per
organization. Grant support is sought from local, state and federal
governments to fill out the budget needs for the projects, which cost
between $300,000 and $400,000. Convincing these parties to participate
and pay requires lengthy meetings and presentations, a process that
takes three to six months, roughly the amount of time needed to launch
the first wave of synergies once the project begins. Smaller companies
often can’t participate due to the costs involved.

Once recruited, these business units are brought together for a series
of structured brainstorming sessions during a nine-month timeframe.
Each participant will provide materials balance information for a
confidential database that will be analyzed by the project team and by
other participants. Together, the participants analyze the extent to
which the waste products or by-products of one industry can be used as
raw materials or ingredients by other industries. Regulatory and
operational agencies at the local, state and federal levels are invited
to participate as project sponsors and as regulatory reviewers of
possible synergies that may be blocked due to specific regulations.
Appropriate research institutions and community organizations may be
invited to participate..

In the working stages of a BPS project, participating company engineers
and operations staffs are exposed to the production processes, raw
material needs, and waste streams of one another’s businesses and
industries. Through extensive collaboration, these participating
companies come to know and trust one another, leading to integration
approaches that cut pollution and reduce material costs, improve
internal processes and boost bottom lines. My company’s waste problem
becomes our companies’ synergy search, as shown in the illustration
below.

Fig. 1 	The BPS process shifts thinking from looking at my company’s
materials to seeking synergies for our companies’ materials.

At the core are the participants. They are asked to commit to the
following:

Information.  Each participant provides all information reasonably
requested the project team pertaining to its industrial operations in
the project area.  All confidential information provided by the
participant and identified as such will not be disclosed to the other
participants (and then, only to the extent necessary to identify product
synergies) without the prior written consent of the participant.

Synergy Identification.  The project team shall work with participants
to identify raw materials, products, and by-products that can be matched
to the needs of a particular industry in the project area.  The project
team shall organize and supervise the project, attempting to identify
and match by-product streams from the participant companies in order to
identify project opportunities.

Project Deliverables.  The project team shall provide the following to
participant companies:

Education and Awareness—Communicate the By-Product Synergy concept to
the company’s executives and operational managers in a series of
meetings.

Data Collection—Provide a uniform methodology and tools for the
collection of material balance information by the company. It is the
company’s responsibility to collect and submit data on schedule.

Analysis—Evaluate the information submitted by the participants,
suggest potential synergies and offer guidance on other potential
synergies.

Facilitated Working Sessions—Organize and conduct group working
sessions for the purpose of analyzing materials data, exploring
potential synergies and evaluating possibilities for implementation.

Evaluation—Assist participant companies and project sponsors with
suggestions for measuring the benefits of the synergies implemented.

Results

Since launching its first multi-company BPS project in 1997 in Tampico,
Mexico, the US BCSD has implemented seven additional projects across
North America, all with strong support from national, state and local
governments. The pace began accelerating in 2006, due in part to higher
energy costs, increasing global competition and greater emphasis by
cities and companies on ecoefficiency and action on climate change. BPS
projects are currently being developed in Chicago, Puget Sound, Central
Ohio, SE Michigan and Connecticut. Results have been mixed, but overall,
the process has continued to produce successes as it has evolved. The
following are summaries of three projects undertaken in the United
States during this time.

Dow Chemical Project

Forty business units from six of Dow Chemical’s US Gulf Coast
manufacturing facilities participated in a BPS project to find ways to
reuse non-chlorinated wastes within Dow by crossing the boundaries
between businesses, sites and plants. Dow provides chemical, plastic,
and agricultural products and services to a variety of consumer markets.

This project, the first phase of a long-term, two-phase project,
estimated that 155 million pounds (70 million kilos) per year of
non-chlorinated waste by-products could be reused by implementing
certain projects. The study also found that the group could save 264
gigawatt hours of energy per year. Total estimated monetary benefits
were $20 million per year for the top nine synergies identified, none of
which involved any significant capital costs.

The US Department of Energy (DOE) cosponsored the assessment as part of
its promotion of ways industry is improving energy efficiency,
productivity, and global competitiveness, while reducing waste and
environmental emissions. In this case, DOE contributed $100,000 of the
total $205,000 assessment cost.

Fig. 2 	Forty businesses from six Gulf Coast Dow Chemical production
facilities participated in the first phase of a BPS project.

Chicago

Chicago Mayor Richard Daley publicly launched the Chicago Waste to
Profit network  in October 2006, urging companies and city departments
to join in an effort to find and implement synergies. Twenty-five
companies and five city departments took on the challenge and by
January, after their first meeting, more than a dozen synergies were
being tested for viability and several were moving toward
implementation. Subsequent meetings are expected to yield significantly
more opportunities.

In Chicago, for the first time, the British version of the by-product
synergy approach was incorporated in a hybrid model designed to take
advantage of both methodologies. The hybrid approach has three spheres
of activity that allow for engagement of large companies, small and
mid-sized companies, and a bridge between the two.

Large Company Sphere

The large companies are recruited to participate in a confidential,
facilitated process designed to allow them to understand one another’s
processes, material flows and operational needs. The goal is to bring
down barriers that hide valuable synergistic opportunities among the
companies. To do this, confidentiality and establishing trust among the
participants is vital. The facilitators guide participants as they
explore, identify and test potentially valuable synergies. Participants
pay a fee to join this group. Each participant signs an agreement that
spells out deliverables, confidentiality, intellectual property and
other important elements needed to create a safe zone for interaction
and collaboration.

SME Sphere

The second sphere involves 30 to 50 small and mid-sized enterprises
(SMEs) organized separately but concurrent with the large company
process. Companies chosen to join this sphere participate free of
charge. Participants are carefully selected using at least three
criteria sets in an effort to identify the best prospects for successful
synergies. They are selected to match the interests of the region in
both producer and receiver categories. Second, the needs of the large
company participants are taken into consideration. And third, successful
synergies from the United Kingdom’s National Industrial Symbiosis
Program (NISP), where similar industries are involved, are used to
choose which enterprises are invited to participate.

Participants will be invited to join a workshop modeled after the NISP
approach, at which they will be asked to provide information on their
needs and their resources; things they can provide and things they want
or can take. This is the US model done in one day. The project team
assesses the results and determines the best opportunities based on
technical analysis and on experiences from US and UK synergy projects.
They aggressively engage with those companies identified as having
priority synergies to drive toward implementation.

Bridged Sphere

The third sphere is coordinated by the project team and bridges the
first two, providing a means of communicating possible synergies from
the larger firms with the smaller, more nimble SME group. The targeted
and planned make-up of the SME group will play an important role in this
cross-over. The large firms will use the project team as their link to
the SMEs, shielding them from direct interaction and freeing them to
explore possible synergies with a greatly expanded potential solution
group through the trust relationship forged with the project team.

The project’s first year report is due in late 2007.

3.2	New Jersey

The Mid-Atlantic By-Product Synergy (BPS) Project was formally launched
in early 2002, with support from 14 participating companies and the
presiding commissioner of the New Jersey Department of Environmental
Protection (NJDEP).  The project sought to identify by-product synergies
in New Jersey and other Mid-Atlantic states and to implement the
most-feasible ones as pilot projects for potential replication
throughout the US.

Initial project activities focused on gaining governmental and political
foundation support for the project, including a formal NJDEP
verification process that determined that the BPS process was a
scientifically and technically sound process for achieving reductions in
energy consumption and environmental impacts.  This verification
expanded the project’s reach within the Mid-Atlantic region.
Partnerships were established with NJDEP, the US EPA, and environmental
agencies in other states. Overall, the BPS Process generated about 80
synergy ideas involving about 35 diverse by-products and 14 companies of
various types and sizes.

After more than one year, none of these synergies had been implemented,
although the project created actual and potential intra-company
synergies. One company found its synergy idea sufficiently compelling
that it implemented similar synergies between company divisions within
one of its other U.S. facilities  Another company began exploring a
potential synergy within its facility, with an outside company providing
by-product processing.

Major conclusions and lessons learned from this project include the
following:

The BPS process facilitates the development and implementation of
synergies largely by providing a structure for companies to meet, to
exchange information, to develop trust, and to work towards synergy
development..

Third-party facilitation is helpful and likely necessary, for sustaining
the BPS process among numerous participating companies.

A BPS project with fewer participating companies is likely to implement
fewer synergies. This reflects the probable scarcity of harmonious
pairings between available by-products and end uses among the
participating companies.

Financial and human-resource constraints likely pose the greatest
barriers to the participation of small companies in synergy projects.

Lack of a synergy champion in each involved company can seriously impede
synergy development and implementation.

Lack of political and regulatory support at the state level can impede
synergy development and implementation.

Because of their potential energy and environmental benefits, synergies
are worth attempting, even at the risk of failure, to learn to develop
and implement them better.

NISP Process

The National Industrial Symbiosis Programme is the first publicly-funded
national industrial symbiosis initiative in the world. It works by
facilitating links between industries from different sectors to create
sustainable commercial opportunities. Not only does it use one
company’s waste as another’s input material, it also considers
symbiosis through expertise, capacity, and logistics.

Services include:

A free independent facilitation service to catalyze collaborative
opportunities, which is delivered through regional coordinators;

Facilitated workshops that bring together diverse organizations with a
common theme in order to find symbiosis opportunities;

A web-based database of ‘stuff people have’ and ‘stuff people
want’ to allow searches for synergies;

Company visits from experts to identify opportunities; and

One-day interactive training workshops to help consolidate
participants’ understanding of industrial symbiosis and use of the
NISP database.

Initiated by the Business Council for Sustainable Development - United
Kingdom, the National Industrial Symbiosis Programme is a well
established resource efficiency and waste minimization program with more
than 6,000 industry members nationally. The first year of Business
Resource Efficiency and Waste (BREW) funding allowed expansion of the
program from two active (English) Regional Development Agency regions to
what is now a fully national program. BREW funding in 2006 amounted to
$17.5 million.

Becoming a member of NISP and gaining access to the database is free and
the opportunities for involvement are wide-ranging.

Between April 2005 and June 2006 NISP has:

diverted 1.6 million tons of waste from landfill

eliminated 423,000 tons of hazardous waste

reduced CO2 emissions by almost 1.3 million tons

saved over 1.8 million tons of virgin materials

reduced industrial water usage by 387,000 ton

created 493 new jobs and safeguarded another 297

been responsible for 15 new business start ups

made cost savings to UK industry totaling over £145 million

generated £65 million in additional sales for its members

seen private investment of £32 million in reprocessing and recycling
plant

been instrumental in the development of numerous brownfield sites

These figures have been independently verified by the British government
and relate to achievements made during the year allowing the fact that
many will persist for years.

By-Product Synergy: A Good Investment?

The by-product synergy market is very complex. There are many examples
of company-to-company waste exchange (bilateral) as well as waste
exchange through the market place. Addressing technical and economic
barriers are critical considerations in achieving successful synergies.
Market segmentation can be based on these two barriers by using a matrix
with technical difficulty on one axis and potential economic return on
the other. High economic return is important to motivate companies to
pursue the waste reuse opportunities in spite of the regulatory
difficulties.

HIGH

Economic benefit(

Low hanging fruit

High risk high return

In-house solutions

Not interesting

	LOW/EASY	Technical difficulty (	HARD

Each quadrant of the diagram represents a different market segment:

Waste reuse with low technical difficulty and low economic return is
typically not of interest to outside parties. The companies that produce
this waste either solve the issue themselves or don’t bother with
reuse of the waste stream and simply dispose of it.

Waste reuse with high technical difficulty and low economical return is
not interesting for any party, although sometimes it can be found on
Internet sites, possibly intended as a long shot from a company that
would like to process the waste differently.

High economical return combined with low technical difficulty (low
hanging fruit) is interesting for everyone, so any efforts in this area
will be characterised by low margins due to the competition. Scanning
through the reuse websites we see that metals, packaging waste, polymer
wastes, wastes suitable for fuel, sand, construction waste, etc are
characterised by both high supply and high demand: a lively and full
marketplace. Most Internet-based brokers are aiming for this type of
waste to drive their business.

High technical difficulty combined with high economic potential (caused
by e.g. high disposal costs or a high intrinsic value) is a very
interesting category for knowledge-based processes, like BPS.
Competition will be limited, but in case of success considerable
brokerage fees can be justified. Of course, the risks of failure are in
line with these higher returns.

An advantage of By-Product Synergy and collaboration among a regional
group of businesses is the potential for cross-industry breakthroughs.
What may pose a technological barrier to one business may be readily
addressed at lower cost by another industry with a particular expertise.
What one business may regard as a high- risk synergy may be a low- risk
synergy to another company if the risk is one that they address in the
ordinary course of their business. BPS permits the matrix to be viewed
both on an individual basis and on a collaborative basis.

Conclusion

The major differences in the UK and US programs are tied to the
financial model and its consequences. In the UK, the program is 100
percent funded by the national and regional governments while in the US
funding is developed project-by-project and is shared by both public and
private sectors. One major result is that in the UK, any company can
participate, which has attracted more than 6,000 participating firms –
90 percent of which are small and mid-sized enterprises (SMEs).

In the US, SME participants are few and far between because they can not
afford to pay the project fees and so are locked out of the process and
its results. The potential exists for reproducing the UK program in the
US, but it will require exploring national or state-level funding
programs, which would allow greater participation from smaller companies
and likely lead to the kind of impressive results seen in the UK.

One step in this exploration could be establishing a dialogue between US
BCSD and its partner, the US EPA, and NISP and its government partner,
the UK Environment Agency. NISP has expressed interest in designing a
means of linking the NISP and BPS programs for future growth. Such a
relationship could fit into the anticipated US BCSD – US EPA
memorandum of understanding to collaborate on sustainable development
initiatives, beginning in China. (In a similar development in the UK,
NISP has been invited by the UK Environment Agency to work with it on
sustainable development dialogues in China, India, Mexico, Brazil and
South Africa.)

  US EPA and Business Council for Sustainable Development for the Gulf
of Mexico, 1997.

 The US BCSD is a non-profit association of businesses whose purpose is
to deliver highly focused, collaborative projects that help its members
and partners demonstrate leadership in the United States on sustainable
development and realize business value.

 The BREW Programme gives grants to projects helping businesses in
England increase their resource efficiency and improve their economic
performance. Funding for the BREW program is derived from a national
landfill tax.

	  DATE  \l  11/3/2008 	  PAGE  2

SEADRIFT

FREEPORT

TEXAS CITY

LA PORT

PLAQUEMINE

ST. CHARLES


[Federal Register Volume 79, Number 75 (Friday, April 18, 2014)]
[Notices]
[Pages 21916-21917]
[FR Doc No: 2014-08918]

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

[EPA-HQ-OAR-2007-1182; FRL-9909-76-OAR]

Proposed Information Collection Request; Comment Request;
Emissions Certification and Compliance Requirements for Nonroad
Compression-Ignition Engines and On-Highway Heavy Duty Engines

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency is planning to submit an
information collection request (ICR), ``Emissions Certification and
Compliance Requirements for Nonroad Compression-ignition Engines and
On-highway Heavy Duty Engines'' (EPA ICR No. 1684.18, OMB Control No.
2060-0287) to the Office of Management and Budget (OMB) for review and
approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501
et seq.). Before doing so, EPA is soliciting public comments on
specific aspects of the proposed information collection as described
below. This is a proposed extension and revision of the ICR, which is
currently approved through August 31, 2014. An Agency may not conduct
or sponsor and a person is not required to respond to a collection of
information unless it displays a currently valid OMB control number.

DATES: Comments must be submitted on or before June 17, 2014.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OAR-
2007-1182, online using www.regulations.gov (our preferred method), by
email to<EMAIL_ADDRESS>or by mail to: EPA Docket Center,
Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania
Ave. NW., Washington, DC 20460.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Nydia Yanira Reyes-Morales,
Environmental Protection Agency, 1200 Pennsylvania Avenue NW., Mail
Code 6403J, Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA will be collecting are available in the
public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, EPA West,
Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting
comments and information to enable it to: (i) Evaluate whether the
proposed collection of information is necessary for the proper
performance of the functions of the Agency, including whether the
information will have practical utility; (ii) evaluate the accuracy of
the Agency's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (iii) enhance the quality, utility, and clarity of the
information to be collected; and (iv) minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate automated electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses. EPA
will consider the comments received and amend the ICR as appropriate.
The final ICR package will then be submitted to OMB for review and
approval. At that time, EPA will issue another Federal Register notice
to announce the submission of the ICR to OMB and the opportunity to
submit additional comments to OMB.
    Abstract: For this ICR, EPA is seeking a revision to an existing
package with a three year extension. Under ICR 1684.18, EPA collects
information regarding heavy-duty on-highway engines and vehicles,
nonroad compression-ignition engines, and categories 1 and 2 marine
compression-ignition engines (collectively referred to here as
``engines'' for simplicity). Please note that category 3 marine engines
and locomotives are covered under separate ICRs.
    Title II of the Clean Air Act, (42 U.S.C. 7521 et seq.; CAA),
charges the Environmental Protection Agency (EPA) with issuing
certificates of conformity for those engines that comply with
applicable emission standards. Such a certificate must be issued before
engines may be legally introduced into commerce. The information
collected is necessary to (1) issue certificates of compliance with
emissions standards and requirements; and (2) verify compliance with
various programs and regulatory provisions. To apply for a certificate
of conformity, manufacturers are required to submit descriptions of
their planned production engines, including detailed descriptions of
emission control systems and test data. This information is organized
by ``engine family'' groups. Engines within an engine family are
expected to have similar emission characteristics.
    The emission values achieved during certification testing may also
be used in the Averaging, Banking, and Trading (ABT) Program. The
program allows engine manufacturers to bank credits for engine families
that emit below the standard and use the credits to certify engine
families that emit above the standard. They may also trade banked
credits with other manufacturers. Participation in the ABT program is
voluntary.
    The CAA also mandates EPA to verify that manufacturers have
successfully translated their certified prototypes into mass produced
engines; and that these engines comply with emission standards
throughout their useful lives. EPA verifies this through `Compliance
Programs' which include Production Line Testing (PLT), In-use Testing
and Selected Enforcement Audits, (SEAs). Not all programs apply to all
industries included in this ICR. PLT, which only applies to marine
engines, is a self-audit program that allows engine manufacturers to
monitor their products' emissions profile with statistical certainty
and minimize the cost of correcting errors through early detection. In-
use testing allows manufacturers and EPA to verify compliance with
emission standards throughout an engine family's useful life. Through
SEAs, EPA verifies that test data submitted by engine manufacturers is
reliable and testing is performed according to EPA regulations.
    There are varying recordkeeping and labeling requirements under all
certification and compliance programs.
    In this notice, former ICR 1826.05 (``Transition Program for
Equipment Manufacturers (TPEM)'', OMB Control Number 2060-0369) is
being incorporated into ICR 1684.18. This action is undertaken to
consolidate compliance information requirements for nonroad compression
ignition engines and equipment under a single ICR for simplification.
With this consolidation, we combine most of the certification and
compliance burden associated with the nonroad compression-ignition
engine and equipment industries. Under TPEM,

nonroad equipment manufacturers are allowed to delay compliance with
Tier 4 standards for up to seven years as long as they comply with
certain limitations. The program seeks to ease the impact of new
emission standards on equipment manufacturers. This is achieved by
allowing additional time for equipment manufacturers to redesign their
products as needed in response to changes in engine designs.
Participation in the program is voluntary. Participating equipment
manufacturers and the engine manufacturers who provide TPEM engines are
required to keep records and submit annual reports.
    The information requested is collected by the Diesel Engine
Compliance Center (DECC), Compliance Division (CD), Office of
Transportation and Air Quality, Office of Air and Radiation, EPA. DECC
uses this information to ensure that manufacturers are in compliance
with applicable regulations and the CAA. The information may also be
used by EPA's Office of Enforcement and Compliance Assurance and the
Department of Justice for enforcement purposes. Most of the information
is collected in electronic format and stored in CD's databases.
    Manufacturers are allowed to assert a claim of confidentiality over
information provided to EPA. Confidentiality is granted in accordance
with the Freedom of Information Act and EPA regulations at 40 CFR Part
2. Non-confidential information may be disclosed on OTAQ's Web site or
upon request under the Freedom of Information Act to trade
associations, environmental groups, and the public.
    Form Numbers: See Table 1 below.

  Table 1--List of Forms Used To Collect Information Under ICR 1684.18
------------------------------------------------------------------------
                 Form                                  No.
------------------------------------------------------------------------
HD/NR Engine Manufacturer Annual        5900-90.
 Production Report.
AB&T Report for Heavy-duty On-highway   5900-134.
 Engines.
AB&T Report for Nonroad Compression     5900-125.
 Ignition Engines.
AB&T Report for Marine Compression-     Number in process.
 ignition Engines.
PLT Report for Marine CI CumSum.......  5900-297.
PLT Report for Marine CI Non-CumSum...  5900-298.
TPEM Equipment Manufacturer             5900-242.
 Notification.
TPEM Equipment Manufacturer Report....  5900-240.
TPEM Engine Manufacturer Report.......  5900-241.
TPEM Bond Worksheet...................  5900-239.
Marine CI Application for               5900-124.
 Certification.
------------------------------------------------------------------------

    Respondents/affected entities: Entities potentially affected by
this action are manufacturers of nonroad compression ignition (CI)
engines, marine CI engines and on-highway heavy-duty engines; owners of
heavy-duty truck fleets, and manufacturers of nonroad compression
ignition equipment.
    Respondent's obligation to respond: Engine manufacturers must
respond to this collection if they wish to sell their products in the
U.S., as prescribed by Section 206(a) of the CAA (42 U.S.C. 7521).
Participation in ABT is voluntary, but once a manufacturer has elected
to participate, it must submit the required information. Likewise,
participation in TPEM is voluntary, but once an engine or equipment
manufacturer chooses to participate, it must submit the required
notifications and annual reports (40 CFR 1039.625 and 1039.626). If
applicable to a particular engine family, compliance programs reporting
is mandatory.
    Estimated number of respondents: 2,350 (total).
    Frequency of response: Annual, quarterly, on occasion.
    Total estimated burden: 244,287 hours (per year). Burden is defined
at 5 CFR 1320.03(b).
    Total estimated cost: $34,470,029 (per year), includes $13,752,082
annualized capital or operation & maintenance costs.
    Changes in Estimates: There is an increase of 70,101 hours in the
total estimated respondent burden compared with the ICR currently
approved by OMB. This increase is due to (1) the merger of ICRs 1684.18
and 1826.05, and (2) an increase in the number of respondents. Please
note that these are preliminary estimates. EPA is still evaluating
information that could lead to a change, likely an increase, in these
estimates.

    Dated: April 11, 2014.
Byron J. Bunker,
Director, Compliance Division, Office of Transportation and Air
Quality, Office of Air and Radiation.
[FR Doc. 2014-08918 Filed 4-17-14; 8:45 am]
BILLING CODE 6560-50-P


Summary of December 15, 2009 Meeting between Honeywell and EPA

Attendees:

David Diggs, Honeywell

Kenneth Horne, Honeywell

Dick Ayres, Ayres Law Group, of counsel to Honeywell

Jessica Olsen, Ayres Law Group, of counsel to Honeywell

Yaidi Cancel, EPA/Stratospheric Protection Division

Melissa Fiffer, EPA/Stratospheric Protection Division

Cindy Newberg, EPA/Stratospheric Protection Division

Margaret Sheppard, EPA/Stratospheric Protection Division

Monica Shimamura, EPA/Stratospheric Protection Division

Representatives from Honeywell mentioned specific issues that they
intend to raise in their public comments on the proposed rule on
HFO-1234yf as an automotive refrigerant.

-Ozone depletion potential

-VOC status-EPA staff mentioned that the petition is being handled by a
sister office, the Office of Air Quality Planning and Standards.

-Trifluoroacetic acid

-Safety and risks of HFO-1234yf, compared to other available
alternatives (e.g., HFC-134a, HFC-152a in secondary loop, CO2)

Representatives from Honeywell also followed up on another SNAP
submission.


King County Environmental Laboratory Standard Operating Procedure MICROBIOLOGY, ENTEROCOCCI IN ENVIRONMENTAL WATER BY MF PAGE 1 OF 12 PAGES Date approved: Revision number: 0 File name: DCTM_ ARP. doc SOP #: 05 04 001 000 STANDARD OPERATING PROCEDURE for Enterococci in Environmental Water by Membrane Filtration SOP # 05 04 001 000 Date of Implementation: 3/ 17/ 03 Supersedes SOP: Microbiology Manual Section 6.3 Approved by:

Supervisor: _______________________________ Date: ________________

QA Officer: _______________________________ Date: ________________

King County Environmental Laboratory 322 W. Ewing Street Seattle WA 98119 1507 King County Environmental Laboratory Standard Operating Procedure MICROBIOLOGY, ENTEROCOCCI IN ENVIRONMENTAL WATER BY MF PAGE 2 OF 12 PAGES Date approved: Revision number: 0 File name: DCTM_ ARP. doc SOP #: 05 04 001 000 CHRONOLOGY OF SOP MODIFICATIONS Revision Number Section Revised Date Implemented / Initials Type of Change Rationale King County Environmental Laboratory Standard Operating Procedure MICROBIOLOGY, ENTEROCOCCI IN ENVIRONMENTAL WATER BY MF PAGE 3 OF 12 PAGES Date approved: Revision number: 0 File name: DCTM_ ARP. doc SOP #: 05 04 001 000 1.0 Scope and Application Enterococci are a subgroup of bacteria of the fecal streptococcus group that includes Enterococcus faecalis, E. faecium, E. gallinarum and E. avium. Enterococci are an indicator of human and animal fecal bacteria contamination. This SOP describes the analysis of environmental water samples using the Membrane Filtration ( MF) procedure and growth on mE agar followed by the hydrolysis of esculin iron agar( EIA).

2.0 Method Summary Appropriate dilutions of the sample, if necessary, are prepared using APHA buffered water as the diluent. The sample and it's dilutions are filtered through a sterile 0.45 µ m nitrocellulose membrane. The membrane is then applied to mE agar plates. After incubation on the mE agar plate at 41 ± 0.5 oC for 48 ± 3 hours, the filter is transferred to EIA agar and incubated for an additional 20 30 minutes. All colonies that have a red to pink color with a black or reddish brown precipitate are counted. The number of colonies per 100 mLs is calculated based on the colonies counted and the dilutions used per plate.

3.0 Definitions Membrane Filtration ( MF): The technique used to determine the number of colonies in a sample using filtration through a nitrocellulose filter of nominal 0.45 µ m pore size and incubation on an agar plate or a liquid substrate pad.

Most Probable Number ( MPN): The density of the bacteria in a sample calculated using probability formulas and the observations of replicate tubes and multiple dilutions.

4.0 Interferences Algae, particulates, colloids, solids or other material, as identified by sample turbidity, may interfere with MF analyses. Samples affected by these interferences should be tested with the MPN method. Non sterile equipment, materials or work environment may also interfere with the MF technique.

5.0 Safety and Hazardous Materials Management Each sample to be tested for Enterococci should be considered a potential biohazard or chemical hazard. Protective equipment such as lab coats should be worn whenever handling samples. Latex or nitrile gloves may also be worn as a protective barrier. Aerosols may also be generated in handling the samples; exercise protective measures. Used plates and contaminated disposable supplies must be stored in containers clearly labeled as biohazardous until sterilized by autoclaving. Autoclaved solid waste may then King County Environmental Laboratory Standard Operating Procedure MICROBIOLOGY, ENTEROCOCCI IN ENVIRONMENTAL WATER BY MF PAGE 4 OF 12 PAGES Date approved: Revision number: 0 File name: DCTM_ ARP. doc SOP #: 05 04 001 000 be discarded in a solid waste container. Liquids not identified as hazardous waste may be discarded in a sanitary drain.

6.0 Sample Collection, Containers, Preservation and Storage Polypropylene ( PP) or high density polyethylene ( HDPE) bottles must be autoclaved and identified as sterile with autoclave tape before being used for sample collection. Containers must be filled such that a minimum of 1 inch of headspace is present. NPDES water samples must be preserved with sterile sodium thiosulfate solution if residual chlorine is present or expected, stored at 4oC, and analyzed within 6 hours of collection. Non NPDES water samples should be preserved with sterile sodium thiosulfate solution if residual chlorine is present or expected, stored at 4oC, and analyzed within 24 hours of collection.

7.0 Apparatus and Equipment 41 ± 0.5 oC incubator Sterile 100 ml graduated cylinders Sterile filter funnels Manifold UV sterilizer for filter funnel units Bunsen burner or other flame source Vacuum source Pipetter Wescodyne or other disinfectant disposal bucket Non serrated forceps Sterile rinse water dispenser 8.0 Preventative Maintenance All reusable equipment that may have been in contact with the samples must be cleaned and sterilized between batches.

9.0 Reagents, Media and Consumables Sterile APHA phosphate buffered dilution water Sterile 18mL APHA phosphate buffered dilution tubes Sterile 1, 5, 10 and 25 ml pipettes or pipette tips (< 2.5% tolerance) 70% alcohol ( ethanol or isopropyl alcohol) Sterile 0.45 µ m membrane filters, nitrocellulose with gridlines, 47 mm diameter Sterile mE and EIA medium in sterile Petri dishes ( See SOP# 05 01 014 000 for media preparation) King County Environmental Laboratory Standard Operating Procedure MICROBIOLOGY, ENTEROCOCCI IN ENVIRONMENTAL WATER BY MF PAGE 5 OF 12 PAGES Date approved: Revision number: 0 File name: DCTM_ ARP. doc SOP #: 05 04 001 000 10.0 Procedures 10.1 Preparation Determine what volumes need to be run for the type of water being analyzed. Consult Appendix A for the suggested analyses volumes for different types of water. The samples are workgrouped in LIMS such that the lab ID# s (" L" numbers), parameters, dilutions, and associated QC samples are defined for a particular batch. Once workgrouped, LIMS can generate a label to be placed on each plate of medium for each specific dilution. The plate must be associated with a sample identifier, the volume of sample tested, the date tested, and the type of test. An electronic login sheet is also generated by LIMS, which records the sample, product, and date workgrouped. The login sheet is used to record the date and time a sample was received and processed, as well as the analysts performing these procedures. For specific information on the use of LIMS for labeling and documenting sample preparation, see " LIMS user's manual for the microbiology section" ( SOP # 05 01 001 000).

If needed, prepare dilutions of the sample. To prepare a 1: 10 dilution, add 2 mL of the sample to an 18 mL sterile APHA buffered water dilution tube. Subsequent dilutions are made in the same manner. Alternate volumes may be used to accommodate the volume of sample available for testing.

10.2 Filtration Set up the vacuum manifold with an inline filter between the vacuum valve and the collection vessel. Place the filtration units on the vacuum manifold and close all manifold valves. Disinfect the non serrated forceps by placing the tips in 70% alcohol solution for 90 seconds. Remove residual alcohol by placing the tips of the forceps briefly in the flame of the Bunsen burner. With the sterile forceps, center a sterile, 0.45 µ m membrane filter on the base of each filter unit, and then place the funnel portion of the unit on the base. Measure the amount of water to be filtered with a graduated cylinder if the volume is > 30 ml, or use a pipette if the volume is   30 ml. If the volume filtered is < 30 ml, add a 30 50 ml reservoir of APHA buffered water to the filter funnel before adding the sample. If the volume to be filtered is 100mLs, the corresponding marking on the filter funnel may be used. Add the sample to the filter funnel and turn on the vacuum. Once the sample is filtered completely, thoroughly rinse the funnel with APHA buffered water, making sure that the sides of the funnel are washed down. Use a minimum of approximately 30 ml for each rinse. Once all the rinse water is filtered through, turn off the vacuum by closing the manifold valve.

Remove the membrane filter from the filtering unit by grasping the edge of the filter with the sterile forceps, and then place the filter onto mE agar plates previously prepared. Try to " roll" the filter onto the agar such that the filter is in complete contact with the agar surface. Check for air bubbles underneath the filter; if there are air bubbles, try lifting the filter by the edge and placing it on the agar again. If this does not work, then touch the edge of the filter with the forceps in such a way as to make it sit in contact with the medium. Do not touch the area of the filter that the sample has gone through only handle the very outside edge. Repeat the disinfection and flaming of the forceps between each King County Environmental Laboratory Standard Operating Procedure MICROBIOLOGY, ENTEROCOCCI IN ENVIRONMENTAL WATER BY MF PAGE 6 OF 12 PAGES Date approved: Revision number: 0 File name: DCTM_ ARP. doc SOP #: 05 04 001 000 sample. UV sterilize funnels for 90 seconds between each sample.

10.3 Incubation Plates should be transferred to the incubator within 30 minutes of filtration. Place the plates, inverted, in the 41 ± 0.5 oC incubator for 48 ± 3 hr. After the 48 hour incubation, transfer the filter to the EIA medium and incubate at 41 ± 0.5 oC for an additional 20 30 minutes. Read the EIA plates immediately after removal.

10.4 Counting Colonies Count with the aid of at least 1 2x magnification with the aid of a fluorescent lamp. Enterococci colonies are those which appear pink to red with a black or reddish brown precipitate. Size of the colony can vary from 1 3 mm. Monthly confirmations are performed on samples as a minimum ( section 11.5). All questionable colonies should have verification steps performed.

10.5 Verification Procedure Questionable colonies, especially colonies from a sample exhibiting atypical morphology, should be verified. Colonies identified as enterococci can be confirmed by incubation in Brain heart infusion ( BHI) broth tubes. After each of the BHI isolates are checked for purity, they are then characterized by lack of catalase production, tolerance to 40% Bile agar, successful esculin hydrolysis, reduction of Methylene Blue, growth in BHI containing 6.5% NaCl, growth in BHI at both 10oC and 45oC, and growth in pH 9.6 BHI broth.

10.6 Data Entry and Qualifiers ( see LIMS Data Entry SOP) Manually enter into LIMS the number of enterococci colonies counted into the " num" value field for each sample and dilution that was workgrouped. A zero value should be entered into the " num" value field only if no characteristic colonies are observed. During manual data entry, qualifiers are entered into the qualifier field in LIMS according to the following conditions:

  If unable to count the colonies due to confluent growth, use a C and do not enter a " num" value.   If the number of target colonies slightly exceeds 60 without confluent growth, or there is background or confluent growth but the analyst believes colony crowding is not adversely affecting a reliable estimate, enter a number value and qualify it with a C.   If the plate exceeds the maximum countable range, an estimate can be taken. For estimates of plates with 3 to 10 target colonies per square, count 10 squares and obtain the average count per square. For plates with 10 to 20 target colonies per square, count 5 squares and obtain the average count per square. Multiply the average count per square by 100 to obtain the plate count, and then report that number with an E qualifier. ( Standard Methods, 9 33).   If the number of target colonies exceeds the countable range and no reliable estimate is available, use TNTC. Once the data is approved, TNTC will be converted to > ### ( the maximum number possible to count, given the volume tested) by LIMS. King County Environmental Laboratory Standard Operating Procedure MICROBIOLOGY, ENTEROCOCCI IN ENVIRONMENTAL WATER BY MF PAGE 7 OF 12 PAGES Date approved: Revision number: 0 File name: DCTM_ ARP. doc SOP #: 05 04 001 000   Other general use qualifiers may also be used for microbiology data ( see Appendix B of KCEL QA Manual)

10.7 Calculating Results Results are entered and calculated using specific programs in Seedpak in LIMS. The LIMS program will calculate the colony count per 100 mL for each sample by using the " batching" method. This method calculates by summing the colony counts of all dilutions where a " num" value was entered and dividing by the corresponding summed total volume of sample filtered. The adjusted count is calculated by multiplying the resultant by 100. See Appendix B.

11.0 QA/ QC Requirements Routine QC analyses for Microbiology include both those procedures used to insure the quality of each batch of media and containers and those procedures used to monitor method performance of each sample analysis batch or analysis session. A sample analysis batch should not exceed 20 samples of the same matrix which are all prepared and analyzed together, using the same reagents, media, and equipment. An analysis session consists of one or more batches done within a working day.

Each batch of media must be tested to confirm pH, sterility, and positive and negative performance characteristics. These specific QC procedures are defined in SOP( s) that describe the preparation and QC checks of mE and EIA media. ( See SOP# 05 01 014 000 for media preparation). After washing and sterilization, each batch of containers used for the collection of the samples must be evaluated for appropriate pH, soap residue, and sterility.

11.1 Lab Duplicates Lab duplicates are prepared for each matrix type at a frequency of 1 per batch or 5%, whichever is more frequent. For MF, the acceptance limits are based on the precision criterion calculated from the duplicates of the previous 15 duplicate pairs ( see Standard Methods, 19th Edition. 9 9). These acceptance limits are updated automatically by LIMS whenever duplicate sample results are entered. If the 15 previous duplicate pairs are unavailable, a senior analyst and/ or supervisor must evaluate the duplicate value.

11.2 Negative Control A negative control is prepared at a frequency of 1 per session. The negative control is a suspension of Staphylococcus species, coagulase negative. The negative control should show an appropriate qualitative response on the media for the test organism and should not be identified as containing enterococci.

11.3 Positive Control A positive control is prepared at a frequency of 1 per session. The positive control is a suspension of Enterococcus faecalis or faecium. The positive control should show an King County Environmental Laboratory Standard Operating Procedure MICROBIOLOGY, ENTEROCOCCI IN ENVIRONMENTAL WATER BY MF PAGE 8 OF 12 PAGES Date approved: Revision number: 0 File name: DCTM_ ARP. doc SOP #: 05 04 001 000 appropriate qualitative response on the media for the test organism and should be identified as containing enterococci.

11.4 System Controls For the MF procedure, both a " pre" and a " post" filtration blank are prepared on the least specific media being used that day at a frequency of 1 set per session. The filtration blanks challenge the same batch of APHA water ( 100 mL) used to dilute and analyze the samples. These system controls are considered acceptable if the target organism for the media is not detected. If the " pre" and " post" filtration blanks show positive results by the least specific method, the controls must be evaluated by each of the more specific methods.

11.5 Verification To ensure analysts' accuracy and method performance, monthly verification tests are performed on 10 colonies picked from various samples being processed that month. Ten colonies identified as enterococci are confirmed by incubation in Brain heart infusion ( BHI) broth tubes. Each of the 10 BHI isolates should first be checked for purity and then characterized by lack of catalase production, tolerance to 40% Bile agar, successful esculin hydrolysis, reduction of Methylene Blue, growth in BHI containing 6.5% NaCl, growth in BHI at both 10oC and 45oC, and growth in pH 9.6 BHI broth. 80% of these isolates must be positive for enterococcus. Verification results are archived in the QC data book.

11.6 Corrective Actions Corrective actions must be taken whenever a QC failure occurs. Unacceptable QC results within a batch or session of analyses require that all samples associated with those batches and/ or session must be reviewed. A decision should be made as to if and how the samples should be qualified. A Corrective Action form should be prepared to document the failure and describe how it was resolved, if possible, and how it could be avoided in the future.

12.0 Reporting, Review and Documentation LIMS raw data sheets are attached to the LIMS hard data review sheets and given to the project coordinator. The project coordinator reviews the results for acceptability based on compliance with holding times, storage and testing conditions, positive and negative controls, filtration blank results, and conformance with both historical and synoptic data. Appropriate dilution effects and consistency with other parameters are also evaluated. Once the results have been shown to meet all criteria, the project coordinator will approve and post the data to EDS tables in LIMS. All hardcopy data is archived by year and project.

13.0 References American Public Health Association. 1998. Method 9230 C. Membrane Filter Techniques. Clesceri, L. S., A. D. Eaton, and A. E. Greenberg ( ed). Standard Methods King County Environmental Laboratory Standard Operating Procedure MICROBIOLOGY, ENTEROCOCCI IN ENVIRONMENTAL WATER BY MF PAGE 9 OF 12 PAGES Date approved: Revision number: 0 File name: DCTM_ ARP. doc SOP #: 05 04 001 000 for the Examination of Water and Wastewater. 20th Edition. American Public Health Association, Washington, DC.

14.0 Training New microbiologists are to be trained at this procedure by first reading the reference method and this SOP, and then observing the method as performed by an experienced analyst. While being directly supervised, the trainee will then perform the method on two separate sets of split samples also performed by an experienced analyst. Once the trainee has produced acceptable QC results and the results of the two sets match those of the experienced analyst, the trainee will be approved as an analyst. King County Environmental Laboratory Standard Operating Procedure MICROBIOLOGY, ENTEROCOCCI IN ENVIRONMENTAL WATER BY MF PAGE 10 OF 12 PAGES Date approved: Revision number: 0 File name: DCTM_ ARP. doc SOP #: 05 04 001 000 Appendix A Suggested Volumes for Enterococcus Analyses by MF Volume Analyzed ( mL) 102 101 100 10 1 10 2 10 3 10 4 10 5 10 6 Project Streams ( routine) x x x Streams ( storms) x x x x Lake Wash. x x Lake Samm. x x Lake Union x x Beaches ( Lakes) x x x Sewage ( raw) x x x x x CSO x x x x x x Trouble Call ( water) x x x x x x Stormwater x x x x x x WP Offshore x Renton Offshore x Beaches * ( Marine) x x * Volumes routinely analyzed are 10, 30 and 100 mL. King County Environmental Laboratory Standard Operating Procedure MICROBIOLOGY, ENTEROCOCCI IN ENVIRONMENTAL WATER BY MF PAGE 11 OF 12 PAGES Date approved: Revision number: 0 File name: DCTM_ ARP. doc SOP #: 05 04 001 000 Appendix B Calculation of Final MF Results " Batching" Method This process takes the colonies counted for the sample and the volume filtered from each of the selected dilutions and performs the following calculations:

1. Sum all counted colonies. 2. Sum all filtered volumes ( only use the volumes of dilutions which produce a numeric value). Remember to also include the volumes of duplicated dilutions if the sample was run in duplicate. 3. Multiply the sum of the counted colonies (# 1 above) by 100 and divide by the sum of the filtered volumes (# 2 above).

( All Counted Colonies) X 100 ( Total Volume Filtered)

This is the adjusted reported value.

The method detection limit is found by following the instructions under special conditions, number two. Special Conditions:

1. If all dilutions resulted in a count of TNTC:

Divide the maximum countable number for the specific procedure ( see chart below) by the smallest volume filtered. Multiply this result by 100. Place this result in the Qualifier Field as part of the "> #####" where "####" is the result. The Value Field is left blank.

Procedure Maximum Countable Number Fecal Coliform 60 Total Coliform 80 E. coli 80 Enterococci 60 Enterococci ( modified incubation) 60 Fecal Streptococci 60 Heterotrophic Plate Count 200 2. If all dilutions resulted in zero counts:

If the largest volume is   100, divide 1 by the largest volume filtered, and then multiply the resultant by 100 to obtain the count per 100ml. Enter this result as `<####' in the qualifier field. King County Environmental Laboratory Standard Operating Procedure MICROBIOLOGY, ENTEROCOCCI IN ENVIRONMENTAL WATER BY MF PAGE 12 OF 12 PAGES Date approved: Revision number: 0 File name: DCTM_ ARP. doc SOP #: 05 04 001 000 If the largest volume is < 100, divide 100 by the largest volume filtered to obtain the count per 100 ml. Enter this result as `<####' in the qualifier field.

Significant Digits:

1. If each value used from individual dilutions has only one significant figure ( counts < 10), the final calculated value should only have one sig. fig. 2. If any value from individual dilutions has 2 or 3 sig. figs, the final calculated value should have no more than the smaller of the number of sig figs ( i. e., if the calculation has both 2 and 3 sig fig numbers, the result should be reported with 2 sig figs). 3. Sig. figs should never exceed 3.


[Federal Register: September 10, 2010 (Volume 75, Number 175)]
[Notices]
[Page 55331-55332]
[DOCID:fr10se10-59]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-E-0041]

Determination of Regulatory Review Period for Purposes of Patent
Extension; SAPHRIS

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

SUMMARY:  The Food and Drug Administration (FDA) has determined the
regulatory review period for SAPHRIS and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of an application to the Director of Patents
and Trademarks, Department of Commerce, for the extension of a patent
which claims that human drug product.

ADDRESSES:  Submit electronic comments to http://www.regulations.gov.
Submit written petitions along with three copies and 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: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 6222, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Public Law 100-670) generally provide
that a patent may be extended for a period of up to 5 years so long as
the patented item (human drug product, animal drug product, medical
device, food additive, or color additive) was subject to regulatory
review by FDA before the item was marketed. Under these acts, a
product's regulatory review period forms the basis for determining the
amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of Patents and
Trademarks may award (for example, half the testing phase must be
subtracted as well as any time that may have occurred before the patent
was issued), FDA's determination of the length of a regulatory review
period for a human drug product will include all of the testing phase
and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
    FDA recently approved for marketing the human drug product SAPHRIS
(asenapine). SAPHRIS is an atypical antipsychotic indicated for acute
treatment of schizophrenia in adults and acute treatment of manic or
mixed episodes associated with bipolar I disorder in adults. Subsequent
to this approval, the Patent and Trademark Office received a patent
term restoration application for SAPHRIS (U.S. Patent No. 5,763,476)
from NV Organon, and the Patent and Trademark Office requested FDA's
assistance in determining this patent's eligibility for patent term
restoration. In a letter dated March 3, 2010, FDA advised the Patent
and Trademark Office that this human drug product had undergone a
regulatory review period and that the approval of SAPHRIS represented
the first permitted commercial marketing or use of the product.
Thereafter, the Patent and Trademark Office requested that FDA
determine the product's regulatory review period.

    FDA has determined that the applicable regulatory review period for
SAPHRIS is 4,547 days. Of this time, 3,833 days occurred during the
testing phase of the regulatory review period, while 714 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i)) became effective:
March 4, 1997. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on March 4,
1997.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the act: August 31,
2007. FDA has verified the applicant's claim that the new drug
application (NDA) for SAPHRIS (NDA 22-117) was submitted on August 31,
2007.
    3. The date the application was approved: August 13, 2009. FDA has
verified the applicant's claim that NDA 22-117 was approved on August
13, 2009.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the U.S.
Patent and Trademark Office applies several statutory limitations in
its calculations of the actual period for patent extension. In its
application for patent extension, this applicant seeks 1,827 days of
patent term extension.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) either electronic or written comments and ask for a
redetermination by November 9, 2010. Furthermore, any interested person
may petition FDA for a determination regarding whether the applicant
for extension acted with due diligence during the regulatory review
period by March 9, 2011. To meet its burden, the petition must contain
sufficient facts to merit an FDA investigation. (See H. Rept. 857, part
1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the
format specified in 21 CFR 10.30.
    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments and written petitions.
It is only necessary to send one set of comments. It is no longer
necessary to send three copies of mailed comments. However, if you
submit a written petition, you must submit three copies of the
petition. Identify comments with the docket number found in brackets in
the heading of this document.
    Comments and petitions that have not been made publicly available
on regulations.gov may be viewed in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: August 13, 2010.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2010-22519 Filed 9-9-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register Volume 83, Number 103 (Tuesday, May 29, 2018)]
[Notices]
[Page 24548]
[FR Doc No: 2018-11364]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Twenty Ninth RTCA SC-222 AMS(R)S Systems Plenary

AGENCY: Federal Aviation Administration (FAA), U.S. Department of
Transportation (DOT).

ACTION: Twenty Ninth RTCA SC-222 AMS(R)S Systems Plenary.

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

SUMMARY: The FAA is issuing this notice to advise the public of a
meeting of Twenty Ninth RTCA SC-222 AMS(R)S Systems Plenary.

DATES: The meeting will be held June 26-27, 2018 8:00 a.m.-12:00 p.m.

ADDRESSES: The meeting will be virtual: https://rtca.webex.com/rtca/j.php?MTID=m34615225fb4b3b129ffe28678abfaf1f; Meeting number (access
code): 634 103 481; Meeting password: KiwuMUi6.

FOR FURTHER INFORMATION CONTACT: Karan Hofmann at [email protected] or
202-330-0680, or The RTCA Secretariat, 1150 18th Street NW, Suite 910,
Washington, DC, 20036, or by telephone at<PHONE_NUMBER>, fax at (202)
833-9434, or website at http://www.rtca.org.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is
hereby given for a meeting of the Twenty Ninth RTCA SC-222 AMS(R)S
Systems Plenary. The agenda will include the following:

Tuesday, June 26, 2018

1. Welcome, Introductions, Administrative Remarks By Special Committee
Leadership
    Designated Federal Officer (DFO): Mr. David Robinson
    Chair RTCA-SC222: Dr. Chuck Laberge, Laberge Engineering
    Chair EUROCAE WG-82: Dr. Armin Schlereth, DFS
2. Agenda Overview
3. Review/Approve Prior Plenary Meeting Summary--(Action Item Status)
4. Coordination With Other Groups (EUROCAE, RTCA, ICAO, SESAR, AEEC)
5. Discussion Of SATCOM Performance Structure (FAA-DFO)
6. SATCOM Co-Site Interference (AIRBUS)
6.1 SATCOM Performance Class B Interference With GNSS
6.2 SATCOM Interference Between Inmarsat And Iridium
7. ATN Over SATCOM--Transition Aspects
8. EASA RMT.0524 Aspects
9. Industry Presentations
10. SC-228 ISRA Discussion
11. Updates On DO-343B/ED-242A And DO-262D/ED-243A
12. Detailed Work Plan For SC-222 And WG-82
13. Establish Agenda, Date And Place For Next Meeting
14. Review Of Action Items
15. Adjourn--Plenary Meeting

Wednesday, June 27, 2018

Continuation Of Plenary Agenda Items
    Attendance is open to the interested public but limited to space
availability. With the approval of the chairman, members of the public
may present oral statements at the meeting. Persons wishing to present
statements or obtain information should contact the person listed in
the FOR FURTHER INFORMATION CONTACT section. Members of the public may
present a written statement to the committee at any time.

    Issued in Washington, DC, on May 22, 2018.
Michelle Swearingen,
Management and Program Analyst, Systems and Equipment Standards Branch,
AIR-6B0, Policy and Innovation Division, AIR-600, Federal Aviation
Administration.
[FR Doc. 2018-11364 Filed 5-25-18; 8:45 am]
 BILLING CODE 4910-13-P


 [Federal Register: October 23, 2009 (Volume 74, Number 204)] [ Notices]                [Page 54827-54829] [DOCID:fr23oc09-50]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0505]

  Agency Information Collection Activities; Proposed Collection;

Comment Request; Recordkeeping and Reporting Requirements for Human

Food and Cosmetics Manufactured From, Processed With, or Otherwise

Containing, Material From Cattle

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an

opportunity for public comment on the proposed collection of certain

information by the agency. Under the Paperwork Reduction Act of 1995

(the 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 of FDA's regulations that require records on FDA-regulated

human food, including dietary supplements, and cosmetics that are

manufactured from, processed with, or otherwise contain, material

derived from cattle.

DATES: Submit written or electronic comments on the collection of

information by December 22, 2009.

ADDRESSES: Submit electronic comments on the collection of

information to http://www.regulations.gov. Submit written comments on

the collection of information to the Division of Dockets Management

(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,

Rockville, MD 20852. All comments should be identified with the docket

number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information

Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane,

Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 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.

Recordkeeping and Reporting Requirements for Human Food and Cosmetics

Manufactured From, Processed With, or Otherwise Containing, Material

From Cattle--21 CFR 189.5(c) and 700.27(c) (OMB Control Number 0910-

0597--Extension)

    Sections 189.5(c) and 700.27(c) (21 CFR 189.5(c) and 700.27(c)) of

FDA's regulations set forth the requirements for recordkeeping and

records access for FDA-regulated human food, including dietary

supplements, and cosmetics that are manufactured from, processed with,

or otherwise contain, material derived from cattle. FDA issued these

recordkeeping regulations under the adulteration provisions in sections

402(a)(2)(C), (a)(3), (a)(4), (a)(5), 601(c), and 701(a) of the Federal

Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 342(a)(2)(C), (a)(3),

(a)(4), (a)(5), 361(c), and 371(a)). Under section 701(a) of the act,

FDA is authorized to issue regulations for the act's efficient

enforcement. With regard to records concerning imported human food and

cosmetics, FDA relied on its authority under sections 801(a) and 701(b)

of the act (21 U.S.C. 381(a)). Section 801(a) of the act provides

requirements with regard to imported food and cosmetics and provides

for refusal of admission into the United States of human food and

cosmetics that appear to be adulterated. Section 701(b) of the act

authorizes the Secretaries of Treasury and Health and Human Services to

jointly prescribe regulations for the efficient enforcement of section

801 of the act.

    These requirements are necessary because, once materials are

separated from an animal, it may not be possible without records to

know the following: (1) Whether cattle material may contain specified

risk materials (SRMs). SRMs include brain, skull, eyes, trigeminal

ganglia, spinal cord, vertebral column (excluding the vertebrae of the

tail, the transverse processes of the thoracic and lumbar vertebrae and

the wings of the sacrum), and dorsal root ganglia from animals less

than 30 months old and tonsils and distal ileum of the small intestine

from all animals of all ages; (2) whether the source animal for cattle

material was inspected and passed; (3) whether the source animal for

cattle material was nonambulatory disabled or mechanically separated

beef; and (4) whether tallow in a human food or cosmetic contains less

than 0.15 percent insoluble impurities.

    These regulations implement recordkeeping for the provisions of

FDA's interim final rule entitled ``Use of Materials Derived From

Cattle in Human Food and Cosmetics'' (the IFR) (69 FR 42256, July 14,

2004). FDA's regulations in Sec. Sec.  189.5(c) and 700.27(c) require

that manufacturers and processors of human food and cosmetics that are

manufactured from, processed with, or otherwise contain, material from

cattle establish and maintain records sufficient to demonstrate that

the human food or cosmetic is not manufactured from, processed with, or

does not otherwise contain, prohibited cattle materials. These records

must be retained for 2 years at the manufacturing or processing

establishment or at a reasonably accessible location. Maintenance of

electronic records is acceptable and electronic records are considered

to be reasonably accessible if they are accessible from an onsite

location. Records required by these sections and existing records

relevant to compliance with these sections must be available to FDA for

inspection and copying. Existing records may be used if they contain

all of the required information and are retained for the required time

period.

    Because we do not easily have access to records maintained at

foreign establishments, FDA regulations in Sec. Sec.  189.5(c)(6) and

700.27(c)(6), respectively, require that when filing for entry with

U.S. Customs and Border Protection, the importer of record of a human

food or cosmetic manufactured from, processed with, or otherwise

containing, cattle material must affirm that the human food or cosmetic

was manufactured from, processed with, or otherwise contains, cattle

material and must affirm that the human food or cosmetic was

manufactured in accordance with the applicable requirements of

Sec. Sec.  189.5 or 700.27. In addition, if a human food or cosmetic is

manufactured from, processed with, or otherwise contains, cattle

material, then the importer of record must, if requested, provide

within 5 business days records sufficient to demonstrate that the human

food or cosmetic is not manufactured from, processed with, or does not

otherwise contain, prohibited cattle material.

    Description of Respondents: Respondents to this information

collection include manufacturers, processors, and importers of FDA-

regulated human food, including dietary supplements, and cosmetics that

are manufactured from, processed with, or otherwise contain, material

derived from cattle.

    FDA estimates the burden of this collection of information as

follows:

    This estimate is based on FDA's estimate of the number of

facilities affected by the final rule entitled,

``Recordkeeping Requirements for Human Food and Cosmetics Manufactured

From, Processed With, or Otherwise Containing, Material From Cattle,''

published in the Federal Register of October 11, 2006 (71 FR 59653 at

59667).

                                                   Table 1.--Estimated Annual Recordkeeping Burden\1\

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                                                              No. of         Annual Frequency       Total Annual

                    21 CFR Section                        Recordkeepers      per Recordkeeping        Records       Hours per  Record        Total

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Domestic Facilities                                                   697                    52             36,244               0.25              9,061

189.5(c) and 700.27(c)

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Foreign Facilities                                                    916                    52             47,632               0.25             11,908

189.5(c) and 700.27(c)

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Total                                                                                20,969

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\1\ There are no capital or operating and maintenance costs associated with this collection of information.

    FDA estimates that there are 697 domestic facility relationships

(71 FR 59653 at 59667), and 916 foreign facility relationships (71 FR

59653 at 59663), consisting of the following facilities: An input

supplier of cattle-derived materials that requires records (the

upstream facility) and a purchaser of cattle-derived materials

requiring documentation--this may be a human food or cosmetic

manufacturer or processor. The recordkeeping burden of FDA's

regulations in Sec. Sec.  189.5(c) and 700.27(c) is the burden of

sending, verifying, and storing documents regarding shipments of cattle

material that is to be used in human food and cosmetics. In this

estimate of the recordkeeping burden, we treat these recordkeeping

activities as shared activities between the upstream and downstream

facilities. It is in the best interests of both facilities in the

relationship to share the burden necessary to comply with the

regulations; therefore, we estimate the time burden of developing these

records as a joint task between the two facilities. Thus, we estimate

that this recordkeeping burden will be about 15 minutes per week, or 13

hours per year (71 FR 59653 at 59667), and we assume that the

recordkeeping burden will be shared between 2 entities (i.e. the

ingredient supplier and the manufacturer of finished products).

Therefore, the total recordkeeping burden for domestic facilities is

estimated to be 13 hours x 697 = 9,061 hours, and the total

recordkeeping burden for foreign facilities is estimated to be 13 hours

x 916 = 11,908 hours, as shown in table 1 of this document.

                                 Table 1.--Estimated Annual Reporting Burden\1\

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                         No. of        Annual Frequency     Total Annual        Hours per

  21 CFR Section      Respondents        per Response        Responses           Response         Total Hours

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189.5(c)(6) and               54,825                  1             54,825              0.033              1,809

 700.27(c)(6)

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\1\ There are no capital or operating and maintenance costs associated with this collection of information.

    FDA's regulations in Sec. Sec.  189.5(c)(6) and 700.27(c)(6) impose

a reporting burden on importers of human food and cosmetics that are

manufactured from, processed with, or otherwise contain, cattle

material. Importers of these products must affirm that the food or

cosmetic is manufactured from, processed with, or does not otherwise

contain, prohibited cattle materials and must affirm that the human

food or cosmetic was manufactured in accordance with the applicable

requirements of Sec. Sec.  189.5 or 700.27. The affirmation is made by

the importer of record to FDA through the agency's Operational and

Administrative System for Import Support. Affirmation by importers is

expected to take approximately 2 minutes per entry line. Table 2 of

this document shows that 54,825 lines of food and cosmetics that likely

contain cattle materials are imported annually (71 FR 59653 at 59667).

The annual reporting burden of affirming whether import entry lines

contain cattle-derived materials is estimated to take 1,809 hours

annually (54,825 lines x 2 minutes per line).

    Dated: October 16, 2009.

David Horowitz,

Assistant Commissioner for Policy.

[FR Doc. E9-25537 Filed 10-22-09; 8:45 am]

BILLING CODE 4160-01-S