January 26, 2012 EPA Written Report from January 19, 2012, Chemical Data Reporting Workshop
On January 19, 2012, Bergeson & Campbell,
P.C. (B&C)
and B&C Consortia Management, L.L.C. (BCCM), affiliates
of The Acta Group, L.L.C., convened a
workshop at which invited U.S. Environmental
Protection Agency (EPA) staff reviewed case studies on
reporting obligations for byproduct and recycled
materials under the Chemical Data Reporting (CDR) rule.
EPA has recently issued a written report on its
responses to the byproduct scenarios BCCM submitted.
The written report is posted with EPA's CDR training
materials online.
A copy of the report, along with a copy of EPA's
slides and recorded audio from the January 19, 2012,
workshop, is also available at B&C's website.
January 26, 2012 International Symposium on Assessing the Economic Impact of Nanotechnology Will Be Held in March 2012
On March 27-28, 2012, the American Association for the Advancement of Science (AAA) will host the "International Symposium on Assessing the Economic Impact of Nanotechnology." The Working Party on Nanotechnology (WPN) of the Organization for Economic Cooperation and Development (OECD), in collaboration with the U.S. National Nanotechnology Initiative (NNI), organized the Symposium. Lynn L. Bergeson is on the Steering Committee and will speak at the Symposium. The objective of the Symposium is to explore systematically "the need for and development of a methodology to assess the economic impact of nanotechnology across whole economies, factoring in many sectors and types of impact, including new and replacement products and materials, markets for raw materials, intermediate and final goods, and employment and other economic impacts." Participants will address the scope of economic impacts of nanotechnology; input and output factors; metrics for other technological assessments; consideration of the appropriateness of these metrics for nanotechnology materials and products; the role of research funding portfolios; intellectual property frameworks; venture capital; public-private partnerships; state and local initiatives; international cooperation; and metrics such as private sector and industry investments, patents and publications, and the development of a technologically-educated workforce as metrics for nanotechnology. Attendees are being invited from a broad spectrum of backgrounds and expertise, including technology leaders, key decision makers, economists, investors, policy analysts, scientists and engineers from industry, business, government, academia, and the general public. Registration will open February 10, 2012, and will be on a first-come, first-served basis until the capacity is met. Positions are expected to fill quickly. More information is available online.
January 25, 2012 Chemical Data Reporting Workshop
On January 19, 2012, Bergeson & Campbell, P.C. (B&C) and B&C Consortia Management, L.L.C. (BCCM) convened a workshop at which invited U.S. Environmental Protection Agency (EPA) staff reviewed case studies on reporting obligations for byproduct and recycled materials under the Chemical Data Reporting rule. For those of you who were unable to listen in, the recorded audio for the workshop is available on B&C's website.
January 23, 2012 Lynn L. Bergeson Will Participate in Webinar on the Greening of Consumer Products
We are pleased to announce that Lynn L. Bergeson will participate in a February 7, 2012, Bloomberg BNA webinar entitled "The Greening of Consumer Products: Legal, Regulatory, and Strategic Considerations." Bloomberg BNA states that the webinar is intended to help users:
Identify the core concepts of green product development and the maturation of conventional environmental protection themes on which green product steward concepts rely;
Describe the diversity of legal and regulatory authorities, domestic and international, that are relevant to chemical, industrial, and consumer product manufacturers from a legal compliance perspective;
Analyze the role of private party standards and evolving concepts of product stewardship in product design and management;
Address the trends and emerging themes embedded in the commercial value chain that must be monitored to be competitive and successful;
Explore the challenges and value of green product marketing; and
Develop basic strategies for legal compliance and commercial success in green product marketing.
January 19, 2012
Chemical Data Reporting Workshop On January 19, 2012, Bergeson & Campbell, P.C. (B&C)
and B&C Consortia Management, L.L.C. (BCCM),
affiliates of The Acta Group, L.L.C., convened a
workshop at which invited U.S. Environmental
Protection Agency (EPA) staff reviewed case studies on
reporting obligations for byproduct and recycled
materials under the Chemical Data Reporting rule. The
following documents are available on B&C's website:
The invitation for the workshop;
EPA's slides; and
The case studies that were compiled by BCCM and that
reflect real-life situations from multiple industry
groups.
A recording of the workshop will be added to
B&C's website in the next few days.
We wish to thank Susan Sharkey and her EPA colleagues
for their very useful and informative presentation.
Our thanks also to the George Washington University
School of Law for its generous offer to host the
meeting.
January 5, 2012
Bergeson & Campbell, P.C. Announces Expanded Blog Reporting on U.S. and International Regulatory and Legal Developments Involving Nanotechnologies and Other Emerging Chemical Technologies
Bergeson & Campbell, P.C. (B&C), an affiliate of The Acta Group, L.L.C., is pleased to announce that, in light of the growing significance of emerging chemical technologies, its Nanotechnology Law Blog has been renamed the Nano and Other Emerging Chemical Technologies Blog and will now report on federal, local, and international regulatory, legal, and policy developments involving nanotechnologies and other emerging chemical technologies. The blog is available at nanotech.lawbc.com. Users may sign up to receive e-mails of new posts to the blog online.
B&C has made a concerted effort to be in the forefront of the science policy debate involving nanotechnologies and other emerging chemical technologies. Lynn L. Bergeson counsels clients on health, safety, science policy, and related legal and regulatory aspects of nanotechnology and emerging transformative technologies, and on more traditional chemical product approval matters. Other B&C and Acta professionals provide counsel on related emerging technologies, including biotechnology and biobased chemical feedstocks. B&C is the proud sponsor of the Third Annual Next Generation Bio-Based Chemicals Summit that will be held on January 23-26, 2012, in San Diego, California (see online).
January 4, 2012
Chemical Data Reporting (CDR) Workshop to Review Case Studies on Reporting Byproducts/Recycled Materials
Thursday, January 19, 2012
9:00 a.m. - 2:00 p.m. (EST)
Bergeson & Campbell, P.C. (B&C) and B&C Consortia Management, L.L.C. (BCCM), affiliates of The Acta Group, L.L.C., have organized a workshop to review reporting obligations for byproducts and recycled materials under the Chemical Data Reporting (CDR) rule. B&C previously submitted to the U.S. Environmental Protection Agency (EPA) specific case studies related to byproducts or recycled materials. The case study scenarios were compiled by BCCM and reflect real-life situations from multiple industry groups. In this workshop, we will review the case studies and EPA’s responses explaining CDR reporting requirements. EPA has been invited to present its responses for CDR reporting requirements for those case studies. A copy of the scenarios and questions submitted to EPA is available on B&C's website.
The workshop will be held on January 19, 2012, at the George Washington University Law School Jacob Burns Moot Courtroom (716 20th Street, N.W., Washington, D.C.). The University is about four blocks from the Foggy Bottom/GWU and Farragut West Metro stations, both of which are on the Metro's Blue and Orange lines. The workshop will also be broadcast as a webinar for interested stakeholders that cannot attend in person.
There is no charge for the workshop or the webinar, but participants should pre-register by January 16, 2012, as space is limited.
B&C and BCCM wish to express their gratitude to the George Washington University Law School for graciously agreeing to host this important event.
December 14, 2011
Bergeson & Campbell,
P.C. Is a Proud Sponsor of the Third Annual Next Generation Bio-Based Chemicals Summit
Bergeson & Campbell, P.C.
(B&C), B&C Consortia
Management, L.L.C. (BCCM), The Acta Group,
L.L.C. (Acta), and The Acta Group EU, Ltd (Acta
EU) are pleased to announce that B&C is a proud
sponsor of the third annual Next Generation
Bio-Based Chemicals Summit, which will be held
on January 23-26, 2012, in San Diego, California.
Returning for a third year, the Next Generation
Bio-Based Chemicals Summit has established
itself as the definitive hub event -- the place
where essential policy and regulatory
information is shared and new industry
relationships are formed. Unlike many other
biotech/biofuels events, this event has a
dedicated, comprehensive, in-depth focus on
sustainability-sourced chemicals, and the
business platforms, resources, business models,
and commercial tools required to deliver them.
Lynn L. Bergeson and James V. Aidala, B&C, and
Charles M. Auer, Charles Auer & Associates, LLC,
will speak on the following topics:
January 23, 2012:
Lynn L. Bergeson will speak on "New
Developments in Chemical Regulatory Policy" from
8:30 – 9:00 a.m.;
Charles M. Auer will speak on "Integrating
Regulatory Factors into Market Entry and
Scale-Up Timelines" from 11:00 – 11:30 a.m.; and
James V. Aidala and Charles M. Auer will
speak on "Bringing it Together -- Assessing the
Opportunities and Managing Regulatory Issues to
Assure Success" from 4:00 – 4:30 p.m.
January 24, 2012:
Lynn L. Bergeson and James V. Aidala will
speak on global chemical regulation and election
year implications during the session, "Is My
Bio-Based Product a 'New' Chemical and Why Does
it Matter?" from 10:00 – 10:30 a.m.
The conference will be held at the Rancho
Bernardo Inn in San Diego, California.
Information on how to register for this event is
available
online.
All B&C clients are
entitled to a 15 percent discount on conference
registration. For more information about
acquiring the discounted registration, please
contact The Acta Group.
November 18, 2011 U.S. News - Best Lawyers "Best Law Firms" Includes Bergeson & Campbell, P.C.
Bergeson & Campbell, P.C. (B&C), B&C Consortia Management, L.L.C. (BCCM), The Acta Group, L.L.C. (Acta), and The Acta Group EU, Ltd (Acta EU) are pleased to announce that B&C is included in the 2011 U.S. News - Best Lawyers "Best Law Firms" rankings for environmental law in Washington, D.C. The methodology for the "Best Law Firms" involved surveying thousands of law firm clients, leading lawyers and law firm managers, partners, and associates, and marketing officers and recruiting officers. The client and lawyer surveys collected mostly reputational data: clients voted on expertise, responsiveness, understanding of a business and its needs, cost-effectiveness, civility, and whether they would refer another client to a firm, while lawyers voted on expertise, responsiveness, integrity, cost-effectiveness, and whether they would refer a matter to a firm and whether they consider a firm a worthy competitor. U.S. News - Best Lawyers combined all of the quantitative and qualitative data into an overall score for each firm. Firms with the highest overall scores were included on metropolitan lists that cover as many as 119 practice areas in 177 metropolitan areas and 7 states and national lists covering 75 practice areas.
October 27, 2011 James V. Aidala Will Speak at the CLA and ABA SEER Pesticides, Chemical Regulation and Right-to-Know Committee Seminar
Bergeson & Campbell, P.C. (B&C), B&C Consortia
Management, L.L.C. (BCCM), The Acta Group, L.L.C.
(Acta), and The Acta Group EU, Ltd (Acta EU) are
pleased to announce that on November 8, 2011, James
V. Aidala will speak at the CropLife America (CLA)
and American Bar Association (ABA) Section of
Environment, Energy, and Resources' (SEER)
Pesticides, Chemical Regulation and Right-to-Know
Committee seminar, What's New, What's Hot in
Pesticide Law and Policy Program, on current
regulatory issues.
The program will explore current legal, litigation,
and policy developments pertinent to the
agricultural chemical community and will feature
three panels. The first panel will focus on how
U.S. Environmental Protection Agency (EPA) policy is
conceived and developed in concert with EPA's Office
of General Counsel, as seen through the lens of
former EPA general counsels. The second panel will
focus on current EPA actions regarding the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA),
Food Quality Protection Act (FQPA), Toxic Substances
Control Act (TSCA), and related chemical enforcement
initiatives. A third panel will address current hot
topics -- legislative priorities, key Supreme Court
decisions, and related developments.
Speakers include:
Panel 1 -- The Development of New Policy: How
Is It Made?
Roger R. Martella, Jr., Esquire (Moderator),
Sidley Austin LLP;
E. Donald Elliott, Esquire, Willkie Farr &
Gallagher LLP; and
Robert E. Fabricant, Esquire.
Panel 2 -- Current FIFRA/FQPA Enforcement
Initiatives
Rosemarie A. Kelley, Director, Waste and
Chemical Enforcement Division, EPA.
Panel 3 -- Current Hot Topics -- Regulatory and
Beyond
Douglas T. Nelson, Esquire (Moderator), CLA;
Leslye M. Fraser, Esquire, Associate General
Counsel, Pesticides and Toxic Substances Law Office,
EPA;
James V. Aidala, Senior Government Consultant,
Bergeson & Campbell, P.C.; and
Lawrence E. Culleen, Esquire, Partner, Arnold &
Porter.
The seminar will be held at the Law Offices of
Arnold & Porter in Washington, D.C. Information on
how to register for this event is available
online.
October 19, 2011 Joseph E. Plamondon Will Speak at the 30th Biennial Western Coatings Symposium
Bergeson & Campbell, P.C. (B&C), B&C Consortia Management, L.L.C. (BCCM), The Acta Group, L.L.C. (Acta), and The Acta Group EU, Ltd (Acta EU) are pleased to announce that on October 25, 2011, Joseph E. Plamondon will speak in Las Vegas, Nevada, at the 30th Biennial Western Coatings Symposium on the regulation of polymers under the Toxic Substances Control Act (TSCA), the European Union's Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation, and the Canadian Environmental Protection Act (CEPA). The Western Coatings Symposium is one of the coatings industry's premier events. Additional information is available online. The Western Coatings Society is a voluntary, nonprofit trade association representing more than 100 paint and coatings manufacturers, raw materials suppliers, distributors, educators, and students. Its objective is to provide technical education and professional development to its members and the coatings industry through its monthly technical presentations, technical documents, job assistance, and scholarships.
October 18, 2011 Kathleen M. Roberts Will Speak at the SBA Environmental Roundtable Meeting
Bergeson & Campbell, P.C. (B&C), B&C Consortia Management, L.L.C. (BCCM), The Acta Group, L.L.C. (Acta), and The Acta Group EU, Ltd (Acta EU) are pleased to announce that on October 21, 2011, Kathleen M. Roberts will speak in Washington, D.C. at the U.S. Small Business Administration's (SBA) Office of Advocacy Environmental Roundtable Meeting on the Toxic Substances Control Act (TSCA) Chemical Data Reporting (CDR) Rule. Discussions will include an overview of the new rule and a summary of the rule's more nuanced provisions. The Roundtable Meeting will focus on recent regulatory developments on the CDR, the Boiler and Associated Air Toxics Rules, and the Integrated Risk Information System (IRIS). Speakers include:
Kathleen M. Roberts, Bergeson & Campbell, P.C.;
Ellie Clark, Office of Chemical Safety and Pollution Prevention, U.S. Environmental Protection Agency (EPA); and
David B. Fischer, American Chemistry Council.
The meeting will be held in Washington, D.C., at the offices of Pepper Hamilton, LLP, 600 14th Street, N.W., Fifth Floor.
October 17, 2011 Lynn L. Bergeson Will Speak During the NanoEHS Workshop Series Webinar
Bergeson & Campbell, P.C. (B&C), B&C Consortia Management, L.L.C. (BCCM), The Acta Group, L.L.C. (Acta), and The Acta Group EU, Ltd (Acta EU) are pleased to announce that on October 20, 2011, from 12:00 p.m. to 12:45 p.m. (EDT), Lynn L. Bergeson will speak during the nanoEHS Workshop Series webinar hosted by the National Nanotechnology Initiative (NNI) on the release of its 2011 Environmental, Health, and Safety Research Strategy (Strategy). The event will consist of an overview of the Strategy's development followed by comments from industrial, regulatory, and public health perspectives. John Howard, Ph.D., Nanotechnology Environmental and Health Implications (NEHI) Working Group Co-Chair, will serve as the moderator. Panelists include:
Lynn L. Bergeson, Esquire, Bergeson & Campbell, P.C.;
Janet Carter, Ph.D., Occupational Safety and Health Administration;
Shaun F. Clancy, Ph.D., Evonik Degussa Corporation; and
Treye A. Thomas, Ph.D., NEHI Working Group Co-Chair.
The webinar will also feature a 20-minute question-and-answer segment following the presentations. Questions may be submitted prior to the webinar to webinar@nnco.nano.gov beginning at 12:00 p.m. (EDT) Wednesday, October 19, 2011, and will be accepted until the close of the webinar at 12:45 p.m. The official 2011 Environmental, Health, and Safety Research Strategy will be released the day of the webinar and posted by 10:00 a.m. (EDT) online. The previously released draft of the Strategy will remain available for viewing online until the official Strategy is posted. Additional information on how to register is available online.
October 3, 2011 Lynn L. Bergeson Will Speak at the Society for Chemical Hazard Communication 2011 Fall Meeting
Bergeson & Campbell, P.C. (B&C), B&C Consortia Management, L.L.C. (BCCM), The Acta Group, L.L.C. (Acta), and The Acta Group EU, Ltd (Acta EU) are pleased to announce that on October 4, 2011, Lynn L. Bergeson will speak in Arlington, Virginia at the Society for Chemical Hazard Communication 2011 Fall Meeting on key issues relating to the Federal Trade Commission (FTC) draft on Green Guides. The presentation will summarize the development of the Green Guides, the review process, claims currently addressed, and claims not currently addressed by the Green Guides. The Society for Chemical Hazard Communication is a professional society committed to serving chemical hazard communication professionals and to promoting knowledge and awareness in all areas of chemical hazard communication. Additional information is available online.
September 16, 2011 BCCM Creates Website for Nanotechnology Initiatives in California
B&C Consortia Management, L.L.C. (BCCM), an affiliate of Bergeson & Campbell, P.C., wishes to ensure that you are aware of a new website designed to be a platform for sharing information on nanotechnology policy, legislative, and regulatory initiatives in California. The website -- www.calnin.org -- provides regular updates on areas and initiatives that could potentially impact the development or use of nanomaterials in California. It also includes information on broader nano-initiatives, recognizing that such initiatives can and will influence nanomaterials policy developments and decisions in California and elsewhere. The site currently includes overviews of key programs to watch in California, as well as policy and viewpoints on nanotechnology from parties outside of California. The home page includes a quick description of the California Toxic Substances Control (DTSC) new leader, Debbie Rafael, who will be instrumental in determining when, how, and whether new nano regulations emerge in California. Visitors also have the opportunity to join the CalNIN mailing list. Subscribers will receive periodic updates that may include information on upcoming events, new developments within the nano-industry, significant updates to the website, and other relevant and timely information. The website has been designed and developed by BCCM as a courtesy to the nano community, and a reflection of our collective commitment to it. We invite you to visit the website and share the information with other interested parties. If you have items that you think should be included on the website, please contact the web administrator, Jake Vandevort.
September 7, 2011 B&C Launches Newly Redesigned Website
Bergeson & Campbell, P.C. (B&C) is pleased to announce the launch of our newly redesigned website, which has been streamlined to make it easier to navigate. The substantive and timely legal and regulatory information we provide remains available. This information covers a wide range of topics, including the Toxic Substances Control Act (TSCA), nanotechnology, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), Green Chemistry, the Food and Drug Administration (FDA), the Occupational Safety and Health Administration (OSHA), Proposition 65, the European Union's (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Program, endocrine disruptors, the Clean Air Act (CAA), the Clean Water Act (CWA), and related chemical and regulatory matters. The B&C website is available at www.lawbc.com. We are committed to providing our clients with top flight, timely information to assist them in their growing businesses, and we hope our new site assists our clients.
August 31, 2011 Bergeson & Campbell, P.C. To Host A Webinar On TSCA Chemical Data Reporting Rule SEPTEMBER 15, 2011 -- SAVE THE DATE
Bergeson & Campbell, P.C. (B&C), B&C Consortia Management, L.L.C. (BCCM), The Acta Group, L.L.C. (Acta), and The Acta Group EU, Ltd (Acta EU) are pleased to announce that B&C will host a complimentary webinar on the final Toxic Substances Control Act (TSCA) Chemical Data Reporting (CDR) Rule on Thursday, September 15, 2011, from 1:30 p.m. to 3:30 p.m. (EDT). This webinar will provide an overview of the new rule, highlight some of the rule's more nuanced provisions, and offer some guidance on how best to respond to it. Memoranda on the CDR rule, EPA Announces Chemical Data Reporting Rule, Which Replaces the IUR Modifications Rule (August 3, 2011) andChemical Data Reporting Rule Analysis: Announcement of Webinar on Chemical Data Reporting Rule (August 16, 2011), are available on the Acta website. Additional details will be sent under separate cover.
August 17, 2011
Kathleen M. Roberts to Speak at the National Association of Chemical Distributors' 2011 OPSEM Conference Bergeson & Campbell, P.C. (B&C), B&C Consortia Management, L.L.C. (BCCM), The Acta Group, L.L.C. (Acta), and The Acta Group EU, Ltd (Acta EU) are pleased to announce that Kathleen M. Roberts of B&C will speak at the National Association of Chemical Distributors' (NACD) 2011 Operations and Purchasing Conference and Trade Show (OPSEM), which will be held August 23-26, 2011, in Sacramento, California. Ms. Roberts will address ongoing regulatory requirements and regulatory initiatives that will impact chemical distributors. B&C will also be exhibiting at the OPSEM. The Conference will highlight information on health, safety, quality, and compliance -- from regulatory requirements and management systems to purchasing best practices and latest technologies being employed in chemical warehouses, distributors, and companies. Additional information on the Conference and how to register is available online.
August 16, 2011 Chemical Data Reporting Rule Analysis: Announcement of Webinar on Chemical Data Reporting Rule
The U.S. Environmental Protection Agency (EPA)
released on August 2, 2011, the pre-publication copy
of the final Toxic Substances Control Act (TSCA)
Chemical Data Reporting (CDR) Rule, previously
referred to as the Inventory Update Reporting (IUR)
Modifications Rule. The rule was published on August
16, 2011. 76 Fed. Reg. 50816. Bergeson & Campbell,
P.C. will host a webinar on the CDR Rule in mid to
late September and will provide under separate cover
webinar registration details.
EPA states that the CDR Rule is intended to enable EPA
to collect and publish information on the
manufacturing, processing, and use of commercial
chemical substances and mixtures on the TSCA Chemical
Substance Inventory (TSCA Inventory). A general
discussion of the CDR Rule (e.g., the key components
of the CDR Rule, how reporting will change from prior
IUR reporting, potential issues with these changes)
was discussed in our August 3, 2011, memorandum,
available
online.
This memorandum provides a more
in-depth analysis for the most significant, and
sometimes controversial, issues presented by the CDR
Rule.
Background Information
As background, it is important to note that the IUR,
now CDR Rule, has been through several iterations
since it was first introduced in 1986. On January 7,
2003, EPA extensively amended the IUR, including, for
example, extending reporting requirements to include
inorganic chemicals, commencing collection of
processing and use information, raising the reporting
threshold from 10,000 to 25,000 pounds
manufacture/import per site, and reducing the
frequency of reporting from one out of every four to
one out of every five years.
On August 13, 2010, EPA proposed TSCA IUR
modifications. 75 Fed. Reg. 49656. One year later,
after lengthy review at the Office of Management and
Budget (OMB), EPA has issued the final, newly-renamed
CDR Rule. Some will rejoice in the fact that EPA
declined to implement some of the more far-reaching
and contentious provisions considered in the proposal,
including the reduction of the reporting threshold,
additional reporting requirements for processors,
retroactive production volume reporting, and Section 5
premanufacture notification (PMN) reporting aspects.
EPA's decision to relent on these topics may indicate
that compromises were reached with OMB on reporting
burdens that allowed the CDR Rule to be issued in its
current form.
Who Is Required to Report?
Under the final CDR Rule, for the 2012 reporting
period, manufacturers (including importers) are
required to report if the manufacture/import volume of
a chemical substance on the TSCA Inventory during the
principal reporting year (i.e., 2011) meets or exceeds
25,000 pounds per site during the principal reporting
year (i.e., calendar year 2011) and is not otherwise
exempt. 40 C.F.R. § 710.48(a) (to be codified in the
new 40 C.F.R. Part 711 as 40 C.F.R. § 711.8(a)). This
is significant in that only one calendar year of
information must be reviewed to determine if reporting
is required, in contrast to the method for determining
reporting obligations for 2016, which requires
manufacturers and importers to review production
volumes for all calendar years since the last
principal reporting year, as discussed below.
One issue that will likely have a significant impact
on certain industries concerns EPA's guidance on the
reporting requirements for "byproducts." EPA's
regulations at 40 C.F.R. § 720.30(g) provide an
exemption from PMN requirements, and thus CDR/IUR
requirements, for byproducts, defined as:
Any byproduct if its only commercial purpose is for
use by public or private organizations that (1) burn
it as a fuel, (2) dispose of it as a waste, including
in a landfill or for enriching soil, or (3) extract
component chemical substances from it for commercial
purposes. (This exclusion only applies to the
byproduct; it does not apply to the component
substances extracted from the byproduct.)
EPA states in the final rule that it is providing
"additional information on byproduct reporting"
because the "scope of the CDR obligation to report
byproducts is not well understood by industry."
Commenters expressed concerns that the proposed IUR
contained new reporting requirements pertinent to
byproduct-related reporting. EPA responded, noted its
disagreement, and stated that EPA is "clarifying, not
enlarging" the byproduct reporting requirements. In
particular, EPA states in the CDR Rule that
"[c]hemical substances that are byproducts of the
manufacture, processing, use, or disposal of another
chemical substance or mixture, like any other
manufactured chemical substances, are subject to CDR
reporting if they are listed on the TSCA Inventory,
are not otherwise excluded from reporting, and their
manufacturer is not specifically exempted from CDR
reporting requirements." EPA further states:
[I]t has been the Agency's position since at least
1991 that, in order for byproduct manufacture to
qualify for the 40 CFR 720.30(g)(3) exemption, "the
component to be extracted must be already existing as
a distinct chemical substance in the waste stream."
When the chemical substance present in the byproduct
and the chemical substance extracted from the
byproduct are distinct chemical substances, neither
the manufacture of the byproduct nor the manufacture
of the extracted chemical substance qualify for the 40
CFR 720.30(g)(3) exemption.
Despite EPA's statements that its rules and guidance
have consistently interpreted the reporting
requirements of "byproducts," this issue became more
complicated after the IUR reporting requirements
expanded to inorganic chemical substances and raised
questions regarding, for example, the interplay
between activities (purification versus extraction)
involving inorganic chemical substances and the
byproduct exemption for both PMN and CDR purposes. It
appears that this issue continues to lack clarity with
regard to whether certain byproducts should be listed
on the TSCA Inventory and/or subject to CDR reporting
and whether EPA has interpreted such terms
consistently and in a way countenanced by TSCA.
Another issue of potential significance is EPA's
revised definition for "manufacture" (to be codified
at 40 C.F.R. § 711.3). The new definition for
manufacture is:
[T]o manufacture, produce, or import, for commercial
purposes. Manufacture includes the extraction, for
commercial purposes, of a component chemical substance
from a previously existing chemical substance or a
complex combination of substances. When a chemical
substance, manufactured other than by import, is:
(1) Produced exclusively for another person who
contracts for such production, and
(2) That other person specifies the identity of the
chemical substance and controls the total amount
produced and the basic technology for the plant
process, then that chemical substance is
comanufactured by the producing manufacturer and the
person contracting for such production.
Commenters argued that this definition was
inconsistent with past definitions, overly-broad, and
confusing. EPA states that this new definition is
intended to "improve the information submitted through
the CDR rule." EPA states that this definition is
consistent with other definitions of "manufacture" in
prior IUR reporting and includes elements from the
definition of "manufacturer" under EPA's PMN
regulations (40 C.F.R. § 720.3). To the extent that
this definition includes references to extraction,
issues similar to those raised for byproducts will be
equally applicable here.
In addition to changing the definition of
"manufacture," EPA has added a paragraph (c) to the
regulation at 40 C.F.R. § 711.22 regarding
"duplicative reporting" to clarify the reporting
relationship between the contracting company and the
toll manufacturer. EPA states that the contracting
company and the toll manufacturer "should confer with
each other to avoid duplicate reporting, and both the
contracting company and the toll manufacturer are
liable if no report is made." EPA reportedly added
this language because it agreed with comments
submitted that its proposed language -- that the
contracting company is "primarily responsible" but the
toll manufacturer must report in the event the
contracting company does not report -- was confusing.
Given the potential disparity between the revised
language regarding reporting obligations and the
complex relationships that may exist between
contracting companies and toll manufacturers, it is
clear that parties will need to agree among themselves
on who should submit CDR Rule reports for which sites
in particular.
A potentially surprising inclusion in the list of
parties required to report are distribution centers
that serve portable manufacturing units. EPA has
expressed its view that units that engage in chemical
reactions via portable manufacturing units are
obligated to report under the CDR Rule if they meet
the reporting threshold. In the August 2010 proposed
rulemaking, EPA provided examples of what may
constitute a "portable manufacturing unit." These
examples include building or road construction
projects that use tanks to produce calcium hydroxide
slurry and agricultural units that remotely produce
ammonium hydroxide for land use.
What Chemical Substances Are Subject
to Reporting?
Chemical substances subject to reporting have not
changed under the CDR Rule from prior IUR rules.
Reportable chemicals are those listed in the Master
Inventory File at the beginning of an applicable
submission period, unless the chemical substance is
specifically excluded. 40 C.F.R. § 710.45 (to be
codified in the new 40 C.F.R. Part 711 as 40 C.F.R. §
711.5). The exemptions from reporting also have not
changed except for limited circumstances: (1) to make
chemical substances for which an enforceable consent
agreement (ECA) to conduct testing has been issued
under 40 C.F.R. Part 790 ineligible for exemptions;
(2) to provide a full exemption from CDR requirements
for water (both naturally occurring and manufactured);
and (3) to remove three polymers from the partially
exempt list, since they are already fully exempt. (To
be codified in the new 40 C.F.R. Part 711 as 40 C.F.R.
§§ 711.6, 711.6(a)(4), 711.6(b)(2)(iv).)
When Is Reporting Required?
When the proposed rule was published in August 2010,
the expectation was the next reporting cycle would be
in 2011, which would include information collected
from 2010. That reporting schedule was shifted in the
final rule, with reporting on information collected in
2011 to occur in 2012. Presumably, EPA viewed this
change as necessary to give industry sufficient time
to prepare for reporting. The unfortunate result of
this change, however, is that industry has potentially
wasted efforts collecting process and use information
in 2010 believing that such information would be
required for reporting in 2011. It is unclear whether
companies anticipated this shift in principal
reporting year from 2010 to 2011 and maintained
information collection systems for 2011 production,
process, and use information.
The 2012 submission period, during which 2011
manufacturing, processing, and use information and
2010 production volume information would be reported,
is scheduled to occur February 1, 2012, to June 30,
2012. Subsequent recurring submission periods will be
from June 1 to September 30 at four-year intervals,
beginning in 2016. 40 C.F.R. § 710.53 (to be codified
in the new 40 C.F.R. Part 711 as 40 C.F.R. § 711.20).
This means, of course, that EPA has again changed the
reporting frequency back to every four years from
every five years.
The timing for 2012 reporting instituted by EPA is
significant, as EPA has actually shortened the
timeframe within which industry must report.
Specifically, for the 2012 report, EPA has set the
reporting deadline from between February and June
2012. Since the last date of processing and use
information to be collected is December 31, 2011, EPA
has provided only two to six months between the last
day of data collection and the submission deadline.
The timeframe originally proposed in EPA's rule, and
that which will apply for 2016 and subsequent
reporting periods, was from June to September. The
end result is that industry has lost three months to
prepare these first reports under the new CDR Rule.
What Is the Standard for Reporting Information?
Starting with the 2012 reporting period, EPA is
replacing the "readily obtainable" reporting standard
used for the reporting of processing and use
information with the "known to or reasonably
ascertainable by" reporting standard. 40 C.F.R. §
710.52(c)(4) (to be codified in the new 40 C.F.R. Part
711 as 40 C.F.R. § 711.15(b)(4)). This change was
widely anticipated. The new reporting standard is more
rigorous than the previous "readily obtainable"
standard, as it is now defined to include "all
information in a person's possession or control, plus
all information that a reasonable person similarly
situated might be expected to possess, control, or
know." By contrast, EPA states that the "readily
obtainable" standard "does not even cover all the
information in a submitter's possession or control."
EPA further states about the "known to or reasonably
ascertainable by" standard:
Under the standard, a submitter would therefore
prepare its report about the processing and use of a
chemical substance it manufactures (including
imports), without confining its inquiry solely to what
is known to managerial and supervisory employees, but
would also be expected to review information which the
manufacturer (including importer) may have in their
possession or control, plus all information that a
reasonable person similarly situated might be expected
to possess, control, or know. The inquiry would be as
extensive as a reasonable person, similarly situated,
might be expected to perform. The standard does not
necessarily require that the manufacturer conduct an
exhaustive survey of all employees.
"Known to or reasonably ascertainable" information
includes, but is not limited to, information that may
be possessed by employees or other agents of the
company reporting under the CDR rule, including
persons involved in the research, development,
manufacturing, or marketing of a chemical substance
and includes knowledge gained through discussions,
symposia, and technical publications. Examples of
types of information that are considered to be in a
person's possession or control, or that a reasonable
person similarly situated might be expected to posses,
control, or know, include files maintained by the
submitter, such as marketing studies, sales reports,
or customer surveys; information contained in standard
references, such as MSDSs, that contain use
information or concentrations of chemicals in
mixtures; and information from the CASRN and from the
D&B number.
EPA provides the following hypothetical examples to
illustrate the anticipated application of this standard:
A Company would not fulfill its duties under this
standard by reporting processing and use information
as "not known or reasonably ascertainable" if it did
not endeavor to supplement the information it
previously knew, by asking its largest customer for
process and use information, when that information was
the type usually maintained by the Company but was
lost due to a computer malfunction.
A Company would not fulfill its duties under this
standard by reporting processing and use information
as "not known or reasonably ascertainable" if it did
not review its largest customer's website to fill data
gaps in how a chemical substance is processed and
used, when that information was never maintained
previously by the Company but is typically collected
from comparable manufacturers as part of reasonable
business practices.
A Company would not fulfill its duties under this
standard by reporting processing and use information
as "not known or reasonably ascertainable" when the
Company had all seasonable marketing data on changes
in use pattern but for one season, and could have
reconstructed that missing marketing data by
contacting its largest customer and requesting such
information.
A Company would have fulfilled its duties under
this standard by reporting information as "not known
or reasonably ascertainable" when the Company has
never maintained information on how a chemical
substance is processed or used by its customers (even
though it is typical for comparable manufacturers to
collect such information as part of their reasonable
business practices), its major customer is unwilling
to supply this information, and the only way for the
Company to obtain such information would be to send a
survey to its ten minor customers.
EPA clarifies that submitters are not required to
conduct a new or additional customer survey to
distribute among multiple customers under this
standard, so that if "particular information cannot be
derived or reasonably estimated from the information
available to the company without conducting further
customer surveys, it is not 'known to or reasonably
ascertainable' to the submitter for purposes of the
CDR." EPA's clarification that customer surveys are
not needed seems to be at odds with other EPA
guidance, which expresses EPA's view that submitters
must search for information that would be "available
after a reasonable inquiry within the organizations"
and that inquiries under this standard "may entail
inquiries outside the organization to fill gaps in the
submitter's knowledge." EPA also states that the
standard for reporting should be an objective
one -- the level of diligence that a reasonable person,
similarly situated, might expect to undertake.
Despite this guidance, these hypothetical examples and
EPA's preamble text present a host of issues that will
likely require additional guidance and greater
clarity. For example, what EPA means by a company's
"largest customer," and what information collections
are considered "typical for comparable manufacturers,"
are important delimiting factors and yet are undefined
terms.
The new reporting standard is also critically
important with regard to an importer's obligations to
report, and yet the final rule lacks clarity. EPA
states: "If an importer does not know and cannot
reasonably ascertain that a particular chemical
substance is present in an imported mixture, it is not
required to report the chemical substance under the
IUR." EPA further states:
If an importer does not know, or can't reasonably
ascertain that a particular chemical substance is
present in a mixture, it is not required to report the
chemical substance. If an MSDS makes no mention of the
presence of an ingredient, and the importer does not
otherwise know that the ingredient is present, EPA
would generally agree that the importer does not know,
and cannot reasonably ascertain that it is importing
that ingredient. Therefore, no IUR report for that
ingredient would be required. In addition,
manufacturers (including importers) are not required
to report impurities.
What Manufacturing-Related Information Must Be
Reported for 2012?
Manufacturing-related information required to be
reported for the principal reporting year (i.e.,
2011), subject to the relevant reporting threshold,
includes the following:
Volume of Chemical Used on Site: Companies must
report the volume of a chemical substance manufactured
(including imported) and used at a reporting site
(replacing the requirement to indicate that the
chemical substance is site-limited). EPA states that
reporting the volume used on-site "provides valuable
information related to potential exposures associated
with the on-site volumes, providing the Agency with
better information for exposure assessments." EPA
also states that this type of information is similar
to that required for PMNs. In response to requests
for clarification as to what activities would be
considered "used at the reporting site," EPA states:
For a domestically manufactured substance, if the
volume would have been considered to be site-limited,
then the chemical substance is used on site. If the
chemical substance is domestically manufactured,
temporarily stored, and then packaged for shipment off
of the site, that volume would not be considered "used
at the reporting site." For an imported substance, any
use at the importing site (e.g., consumed in a
reaction or cross-linked or cured in an article) would
be considered "used at the reporting site."
Volume Directly Exported: Companies must report
the volume of the chemical substance directly exported
and not domestically processed or used. EPA states
that a chemical substance that "is processed in any
way (e.g., combined with other chemical substances to
form a mixture)" or that is sent to a distributor who
then exports it, is not considered "directly
exported."
Volume Recycled, Remanufactured, Reprocessed, or
Reused: Despite concerns raised that terms like
"recycle" are not well defined and will lead to
difficulties in determining reporting obligations, EPA
will require manufacturers to check a box to indicate
whether a chemical substance they manufactured, such
as a byproduct, which might otherwise be disposed of
as waste, was or is expected to be recycled. EPA
disagreed that a precise definition of "recycle" is
needed, and asked submitters instead to "indicate, to
the extent that they know or can reasonably ascertain,
whether the reported volume of the chemical substance
that they manufactured, which would otherwise be
disposed of as waste, was or is expected to be
recycled, remanufactured, reprocessed, or reused, as
those terms are understood by the submitter." Because
the term "reworked" could be applied too broadly, EPA
removed that term from the list of recycling synonyms.
In addition to the 2011 information outlined above,
companies must also report production volume for
calendar year 2010.
What Processing and Use-Related Information Must Be
Reported for 2012?
The new processing and use-related information
required to be reported is set forth in 40 C.F.R. §
710.52(c)(4) (to be codified in the new 40 C.F.R. Part
711 as 40 C.F.R. § 711.15(b)(4)). For 2012 reporting,
processing and use-related information required to be
reported includes, for the principal reporting year
only (i.e., 2011), processing and use information of
all reportable chemical substances manufactured at
100,000 pounds or more per site, unless otherwise
exempted. This means that EPA is amending 40 C.F.R. §
710.52(c) (to be codified in the new 40 C.F.R. Part
711 as 40 C.F.R. § 711.15(b)) to reduce the reporting
threshold for processing and use information from
300,000 to 100,000 pounds per chemical substance for
the 2012 reporting period.
Among the new processing and use information changes
are the requirement to report consumer and commercial
product categories separately to distinguish between
the use types; to report consumer and commercial use
information using a revised list of consumer and
commercial product category codes; and to report the
total number of commercial workers, including "those
at sites not under the submitter's control," that are
reasonably likely to be exposed while using the
reportable chemical substance, with respect to each
commercial use. EPA states that it had difficulty
evaluating exposures from commercial workers and
consumers based on the processing and use data it
obtained during the 2006 IUR because that data did not
differentiate between these populations. EPA
acknowledges, however, that it received comment
opposing this requirement because, according to EPA,
some companies "were too removed from the consumer and
commercial uses to have a clear understanding of the
uses at that level of distinction, especially for
commodity chemical substances with a large number of
uses." EPA has attempted to reduce the reporting
burden regarding the number of commercial workers by
requiring that this information only be reported in
ranges.
EPA's decision to add a reporting requirement for
number of workers for commercial uses, even in ranges,
is significant and may prove particularly challenging
for industry to report. While some of this
information may be available, on the Internet for
example, there may be many cases where the breadth of
the uses of the chemical and the number of potential
sites and customers could require submitters to
utilize large amounts of time, resources, and energy
to collect such information, analyze it, and report
it. In addition, it is unclear how EPA may react if
companies opt to rely on "worst case" scenario values
that may actually distort commercial uses and thus may
be viewed by EPA as over-reporting. Indeed, EPA has
issued penalties to companies that reported values
higher than actual in past IUR reporting. The "not
known or reasonably ascertainable" standard discussed
above thus will be particularly instructive and
important to understand with respect to these
reporting elements.
How To Substantiate CBI?
While claims for confidentiality for chemical identity
and site identity previously required substantiation,
a new requirement starting with the 2012 reporting
period is the need to provide upfront substantiation
for each processing and use data element claimed as
CBI if the submitter has reason to believe that
release of the information would reveal trade secrets,
or confidential commercial or financial information.
40 C.F.R. § 710.58 (to be codified in the new 40
C.F.R. Part 711 as 40 C.F.R. § 711.30). The
substantiation questions for processing and use
information (to be codified at 40 C.F.R. § 711.30(d))
have been modified from the proposed rule in one
respect in recognition that there are circumstances
when the release of information about a particular use
could harm the competitive position of the submitter's
customer. Thus, the new substantiation questions
expressly allow a submitter to identify any harmful
effect to a customer's competitive position in
addition to the submitter's competitive position when
describing competitive harm. To reduce further the
potential for "unwarranted" CBI claims, EPA also
states that submitters cannot claim as confidential
any processing and use information identified as "not
known to or reasonably ascertainable by."
EPA also clarifies some CBI substantiation points.
For example, EPA states that company name and site
identity are separate CBI claims, and in some cases
one type of claim may be justified while the other is
not. EPA will not "impute the existence of a CBI
claim for site identity from a CBI claim for company
identity, even if the company name appears within the
site identity information."
EPA further states that a submitter must provide
separate substantiation for any site identity CBI
claims associated with each chemical substance. Thus,
"if the submitter is reporting for five chemical
substances and wishes to claim its site information
confidential for three of the five chemical
substances, it must assert the claim and provide
separate upfront substantiation three times, once for
each of the three chemical substances."
Of particular interest, and on a more ominous note, in
the final CDR Rule EPA "cautions submitters that they
may be subject to criminal penalties under 18 U.S.C.
1001 if they knowingly and willfully make a false
statement in connection with the assertion of a CBI
claim." The statute cited by EPA is not TSCA, since
TSCA provides that criminal sanctions (fines or
imprisonment or both) may be imposed for any person
who knowingly or willfully violates any of the
prohibited acts enumerated in TSCA Section 15 or 409,
and those prohibitions do not include a prohibition
against making false confidentiality claims. The
statute EPA references is the general, catch-all
provision for fraud and false statements found at 18
U.S.C. § 1001(a). The provision reads:
Except as otherwise provided in this section, whoever,
in any matter within the jurisdiction of the
executive, legislative, or judicial branch of the
Government of the United States, knowingly and
willfully–
(1) falsifies, conceals, or covers up by any trick,
scheme, or device a material fact;
(2) makes any materially false, fictitious, or
fraudulent statement or representation; or
(3) makes or uses any false writing or document
knowing the same to contain any materially false,
fictitious, or fraudulent statement or entry;
shall be fined under this title, imprisoned not more
than 5 years or, if the offense involves international
or domestic terrorism (as defined in section 2331),
imprisoned not more than 8 years, or both.
While EPA references 18 U.S.C. § 1001 in other
contexts (e.g., persons that file false or misleading
"Affirmation of Non-Multinational Status" forms to EPA
under FIFRA Section 10(g) can be punishable under 18
U.S.C. § 1001, false or misleading statements with
regard to TSCA GLP standard can be punishable under 18
U.S.C. § 1001 (40 C.F.R. § 792.17)), the inclusion of
this language in the final rule may telegraph EPA's
heightened scrutiny of CBI substantiation claims,
perhaps as part of EPA's enhanced chemical
transparency campaign.
EPA states that there are three circumstances when EPA
will release CDR information claimed as CBI without
further notice to the submitter. These include: a
CBI claim made for the identity of a chemical
substance already listed on the non-confidential
portion of the TSCA Chemical Inventory; a submission
lacking the certification signed and dated by the
authorized official for the submitter (as required
under the regulation to be codified at 40 C.F.R. §
711.15(b)(1)); or a claim requiring upfront
substantiation that is not accompanied by the
requisite substantiation.
What Must Be Reported for 2016?
While the 2012 reporting period is scheduled for
February 1, 2012, to June 30, 2012, subsequent
recurring reporting periods will be from June 1 to
September 30 at four-year intervals, beginning in
2016.
The method by which manufacturers and importers must
determine their reporting obligations is different in
2016 than 2012. For 2012, the only applicable
timeframe to determine reporting requirements is
whether the manufacture/import volume of a chemical
substance on the TSCA Inventory during the principal
reporting year (i.e., 2011) meets or exceeds 25,000
pounds per site during the principal reporting year
(i.e., calendar year 2011). For 2016 and beyond,
manufacturers and importers must review production
volumes for all calendar years since the last
principal reporting year. EPA states:
EPA is finalizing this change because of the mounting
evidence that many chemical substances, even larger
production volume chemical substances, often
experience wide fluctuations in production volume from
year to year. (See Unit III.D.1. of the proposed rule
(Ref. 1).) This can result in the production volume of
a chemical substance exceeding the threshold for
several years, then falling below the threshold during
the CDR principal reporting year. EPA believes that
using production volume reporting for all years since
the last principal reporting year to determine
reporting obligations will yield a much more accurate
picture of the chemical substances currently in
commerce, ensuring proper review under EPA's risk
screening, assessment, and management activities and
providing better information to the public.
EPA also is delaying implementation of certain
requirements until the 2016 submission period to allow
submitters time to become familiar with the new
requirements. These issues are set forth in the
following chart:
Issue
2012
2016
Citation
Comment
Reporting Periods
February 1 to June 30, 2012
June 1 to September 30, 2016 (and
same timeframes in subsequent reporting years, 2020, 2024, etc.)
To be codified at 40 C.F.R. § 711.20
EPA determined that reporting
every five years is too infrequent and does not provide enough data to sufficiently cover the needs of EPA or the public.
Method to Determine Whether a
Manufacturer/ Importer Is Subject to CDR Reporting
For 2012, reporting is
required if the manufacture/ import volume of a chemical substance meets or exceeds 25,000 pounds per site during
the principal reporting year (e.g., 2011).
Starting with 2016, reporting
is required if the manufacture/ import volume of a chemical substance meets or exceeds 25,000 pounds per site
for any calendar year since the last principal reporting year.
EPA is amending 40 C.F.R.
§ 710.48(a) (to be codified in the new 40 CFR Part 711 as 40 C.F.R. § 711.8(a))
EPA believes that using production
volume reporting for all years since the last principal reporting year to determine reporting obligations will yield
a much more accurate picture of the chemical substances currently in commerce.
Manufacturing Threshold for Chemicals
Subject to Certain TSCA Rules/Orders (Sections 5, 6, 7)
For 2012, there is a 25,000 pound per
site threshold for specific chemical substances that are the subject of particular TSCA rules and/or orders.
Starting with 2016, the new reporting
threshold for these chemical substances is 2,500 pounds per site.
EPA is amending 40 C.F.R. §
710.48(a) (to be codified in the new 40 C.F.R. Part 711 as 40 C.F.R. § 711.8(b))
This new reporting threshold is
different from the proposed rule, under which reporting would have applied regardless of the production volume. EPA
decided to set a de minimis threshold and to delay its implementation for several reasons identified by commenters
(e.g., "the expense and burden of collecting the information, and difficulty in knowing whether low-concentration
chemical substances are present in formulated mixtures").
Production Volume Reported
For 2012, only report production
volumes for calendar year 2010.
Starting with 2016, report
production volumes for each year since the last principal reporting year (i.e., for 2016, report for 2012,
2013, 2014, 2015).
EPA is amending 40 C.F.R. §
710.52(c) (to be codified in the new 40 C.F.R. Part 711 as 40 C.F.R. § 711.15(b))
The requirement to report
volumes for multiple years had been proposed to apply since 2005, but in the final CDR Rule it applies only
for 2016 and beyond.
Processing and Use Threshold
Lowered for the 2012 reporting
period from 300,000 pounds per site to 100,000 pounds per site.
Starting with 2016, the reporting
threshold for processing and use information will be 25,000 pounds per site.
EPA is amending 40 C.F.R. §
710.52(c) (to be codified in the new 40 C.F.R. Part 711 as 40 C.F.R. § 711.15(b))
There will be no separate
threshold for the reporting of production and use information after
2012 -- the applicable reporting threshold will be the same as for other types of information (25,000 pounds per site).
How Must Information Be Submitted?
Starting with the 2012 reporting period, EPA will
require the use of its electronic reporting tool,
e-CDRweb, to submit all CDR information through the
Internet. EPA states that "requiring the use of
electronic reporting will ensure that data are
available in a timely manner and will reduce data
entry errors, thereby increasing the usability and
reliability of the data for EPA and other Federal
agencies. It will also help to fulfill the EPA
Administrator's commitment to increase public access
to information on chemical substances."
While there has been general support to move toward
electronic reporting, there are issues to be
addressed, particularly regarding ensuring that
information claimed as CBI is protected and the use of
electronic signatures. EPA responded to concerns
raised during the comment period regarding the need
for multiple notarized signatures on the Electronic
Signature Agreement (ESA) Form by determining that
requiring a notarized signature as part of the ESA
Form is no longer necessary.
EPA held an information workshop and webinar on
November 30, 2010, to help companies develop a better
understanding of the EPA's Central Data Exchange (CDX)
registration process and the e-CDRweb electronic
reporting tool. A recording of the workshop and a
summary of the questions and answers is available on
the IUR website
(online).
EPA also intends to conduct a webinar on September 23, 2011,
to demonstrate e-CDRweb. According to EPA, those
interested will be able to test the tool during the
following week. The test version will not be usable
for 2012 submissions. More information is available
online.
Given the additional complexity of the information to
be reported and the shortened reporting cycle, it is
reasonable to expect that the vast majority of
impacted entities will wait until the last few weeks
in the reporting cycle to submit information. Despite
numerous concerns raised by industry in comments, EPA
has not offered to our knowledge a contingency plan
should the electronic reporting system crash due to a
mass rush of submissions or large number of parties
trying to sign onto the system. EPA may well have a
back-up plan, but we hope using it proves to be
unnecessary.
August 1, 2011 Lynn L. Bergeson Will Speak at the Fifth International Symposium on Nanotechnology, Occupational and Environmental Health
Bergeson & Campbell, P.C. (B&C), B&C Consortia Management, L.L.C. (BCCM), The Acta Group, L.L.C. (Acta), and The Acta Group EU, Ltd (Acta EU) are pleased to announce that on August 9, 2011, Lynn L. Bergeson will speak in Boston, Massachusetts, at the Fifth International Symposium on Nanotechnology, Occupational and Environmental Health (NanOEH) on key policy and regulatory considerations related to nanotechnology. The program will focus on life cycle assessment: what assessment tools and options are appropriate for nanomaterials; nanoinformatics: how to get the needed information for meaningful assessments; and policy and regulatory matters: what is the current landscape. The National Institute for Occupational Safety and Health (NIOSH) is a co-sponsor of this event.
B&C has made a concerted effort to be in the forefront of the science policy debate involving nanotechnologies and other emerging technologies. Ms. Bergeson and other professionals at B&C counsel clients on health, safety, science policy, and related legal and regulatory aspects of nanotechnology and emerging transformative technologies, and on more traditional chemical product approval matters. Ms. Bergeson serves on a number of domestic and international nanotechnology standard setting and governance committees, and writes and lectures frequently on nano-related topics. Recent publications include: Nanotechnology: Environmental Law, Policy, and Business Considerations, ABA (2010); "New on the Horizon: Nanotechnology," in Product Liability, ABA (2010) (co-author); Nanotechnology and the Environment, CRC Press (2008) (co-author); and Nanotechnology Deskbook, ELI (2007) (co-author). Ms. Bergeson writes frequently on emerging technologies, and is a regular contributor to the Nanotechnology Industries Association's (NIA) Newsletter (the Newsletter is free to NIA members; subscriptions are available online) and to Nanotechnology Now (available online). More information is available online.
The symposium will be held at the Westin Boston Waterfront hotel. Additional information on how to register for the program is available online.
July 21, 2011 Lynn L. Bergeson Listed Among Top Women Lawyers in the Northeast
Bergeson & Campbell, P.C. (B&C), The Acta Group, L.L.C. (Acta), and The Acta Group EU, Ltd (Acta EU) are pleased to announce that Lynn L. Bergeson is included on Martindale-Hubbell's list of top women lawyers in the Northeast, in the category of environmental law. Martindale-Hubbell used its comprehensive database of Martindale-Hubbell Peer Review Ratings to identify women lawyers who have been rated by their peers to be AV Preeminent -- the highest Peer Review Rating available. More information regarding Martindale-Hubbell Peer Review Ratings is available online.
July 19, 2011 Bergeson & Campbell, P.C. Is a Proud Sponsor of the NanoBusiness Commercialization Association's Tenth Annual NanoBusiness Conference and Nanomanufacturing Summit 2011
Bergeson & Campbell, P.C. (B&C), B&C Consortia Management, L.L.C. (BCCM), The Acta Group, L.L.C. (Acta), and The Acta Group EU, Ltd (Acta EU) are pleased to announce that B&C is a proud sponsor of the NanoBusiness Commercialization Association's (NanoBCA) Tenth Annual NanoBusiness Conference and Nanomanufacturing Summit 2011, which will be held September 25-27, 2011, in Boston, Massachusetts. Lynn L. Bergeson will moderate a panel discussing key nanotechnology-related environmental, health, and safety issues impacting businesses. Ms. Bergeson serves on NanoBCA's Advisory Board and is Chair of NanoBCA's Environment, Health, and Safety Committee.
The Conference will showcase technical contributions by experts and practitioners in the field of nanomanufacturing. It will highlight those areas of practice that stand out from the general nanotechnology and nanoscience themes as being near-term and having the potential to facilitate the commercial development and/or marketable application of nanoscale materials, systems, and devices.
B&C has made a concerted effort to be in the forefront of the science policy debate involving nanotechnologies and other emerging technologies. Ms. Bergeson and other professionals at B&C counsel clients on health, safety, science policy, and related legal and regulatory aspects of nanotechnology and emerging transformative technologies, and on more traditional chemical product approval matters. Ms. Bergeson serves on a number of domestic and international nanotechnology standard setting and governance committees, and writes and lectures frequently on nano-related topics. Recent publications include: Nanotechnology: Environmental Law, Policy, and Business Considerations, ABA (2010); "New on the Horizon: Nanotechnology," in Product Liability, ABA (2010) (co-author); Nanotechnology and the Environment, CRC Press (2008) (co-author); and Nanotechnology Deskbook, ELI (2007) (co-author). Ms. Bergeson writes frequently on emerging technologies, and is a regular contributor to the Nanotechnology Industries Association's (NIA) Newsletter (the Newsletter is free to NIA members; subscriptions are available online) and to Nanotechnology Now (available online). More information is available online. Additional information on the Conference and how to register is available online.
July 5, 2011
The Nuances of 'Nano' in Pesticide Products
The Acta Group, L.L.C. is pleased to announce that Lynn L. Bergeson, James V. Aidala, and Charles M. Auer published an article appearing in the July 1, 2011, issue of Law360. The article, which is entitled "The Nuances of 'Nano' in Pesticide Products," discusses the U.S. Environmental Protection Agency's much-anticipated notice describing possible approaches for obtaining information on the potential presence of nanoscale materials in registered pesticide products.
The article is available online. We hope this information is helpful
June 14, 2011 Lynn L. Bergeson Inducted Into The American College Of Environmental Lawyers
Bergeson & Campbell, P.C. (B&C), The Acta Group, L.L.C. (Acta), and The Acta Group EU, Ltd (Acta EU) are pleased to announce that Lynn L. Bergeson on June 9, 2011, was inducted into the American College of Environmental Lawyers (ACOEL), which is a professional association of preeminent lawyers who practice in the field of environmental law. Membership is invitation only and members are recognized by their peers as the best practitioners in their field. ACOEL's purpose is to maintain and improve the standards of practice, administration of justice, and ethics of the profession, and contribute to the development of environmental law at both the state and federal level. Membership eligibility is limited to those who have practiced environmental law for at least 15 years and whose practice for the past five years has been at least 50 percent in environmental law. More information on ACOEL is available online.
June 3, 2011 Andrew Bourne Joins Bergeson & Campbell, P.C.'s Affiliate, The Acta Group EU, Ltd, and Brings Valuable Experience in International Chemical Regulatory Matters Bergeson & Campbell, P.C. (B&C), B&C Consortia Management, L.L.C. (BCCM), The Acta Group, L.L.C. (Acta), and The Acta Group EU, Ltd (Acta EU) are pleased to announce the addition of Andrew Bourne to its European Union consulting practice. Mr. Bourne's experience in international chemical regulatory programs will supplement the skill sets of other Acta EU professionals and provide even greater service to our growing client base.
Mr. Bourne previously worked for Exponent International Ltd. (Exponent) as a Regulatory Affairs Specialist where he was a liaison for Substance Information Exchange Forum (SIEF) members, steering groups, and downstream users for the compilation of substance identification and available substance data and risk management information for the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) phase-in 2010 deadlines. In addition, he produced several Chemical Safety Reports (CSR) for Annex IX and X registrations and assisted in biocides and plant protection registrations. Prior to his work at Exponent, Mr. Bourne was a Regulatory Affairs Officer at Harlan Laboratories Ltd., where he managed non-phase-in and worldwide registrations and notifications of chemical substances and produced training documents for REACH. Mr. Bourne has a degree in environmental science and environmental management.
June 1, 2011 Upcoming Webinar Will Focus on REACH Data Citation/Compensation Scheme
Bergeson & Campbell, P.C. (B&C), The Acta Group, L.L.C. (Acta), and The Acta Group EU, Ltd (Acta EU) are pleased to announce that on June 23, 2011, Lynn L. Bergeson, Lisa R. Burchi, and Leslie S. MacDougall will participate in a webinar entitled "The Evolving REACH Data Citation/Compensation Scheme: What to Watch for and Why." The European Union's (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation is a complex chemical management regulation intended to replace approximately 40 previously existing legal instruments with a single EU regulatory scheme for all chemical substances (both new and existing substances). Importantly, REACH also creates a data compensation scheme for entities that must rely upon studies generated by another entity to complete their registration for a particular chemical substance. The webinar will review pertinent REACH registration provisions within the broader construct of the REACH program and focus on REACH's data compensation and data sharing procedures. The presenters will compare and contrast REACH's data compensation principles with how similar issues are addressed in the context of U.S. Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) data compensation arbitrations, practices, and protocols. Registration for the webinar is available online.
The webinar features data compensation experts on both sides of the Atlantic: Lynn L. Bergeson, Lisa R. Burchi, and Leslie S. MacDougall, of B&C, and Ruxandra Cana, Indiana de Seze, and Michel Michaux, of Field Fisher Waterhouse LLP. Key topics that will be considered include:
REACH vs. FIFRA: Overview of key data sharing/data compensation;
REACH Substance Information Exchange Forum (SIEF)/Consortia data development, data sharing, data compensation, and antitrust;
Data compensation under REACH vs. data compensation under FIFRA (focusing on publicly available studies, compensability period, study quality, historic v. replacement costs, overhead, cost allocation, inflation, risk premium, interest, rights obtained as a result of compensation, and SIEF members and consortium members);
Dispute resolution under REACH vs. dispute resolution under FIFRA (focusing on disputes involving the European Chemicals Agency, court proceedings, arbitration, and antitrust concerns); and
Data sharing experiences under REACH to date, including key issues, forecast, and next steps.
May 3, 2011 Lynn L. Bergeson Included on "Super Lawyers" List
We are pleased to announce that the 2011 edition of Washington, D.C., Super Lawyers, a Thomson Reuters Service, includes Lynn L. Bergeson on its list of top lawyers in environmental law. To compile the list, Super Lawyers asked lawyers in Washington, D.C., to name the top attorneys. Super Lawyers also performed its own research to find outstanding attorneys who may have been overlooked. Once Super Lawyers assembled its candidate pool, it assessed the background, credentials, and experience of each lawyer, looking at 12 indicators of peer recognition and professional achievement. A blue ribbon panel of peers then evaluated the lawyers within their primary area of practice. Super Lawyers divided the lawyers by firm size and chose the top lawyers from each group to create a list representing five percent of the lawyers in Washington, D.C. Financial considerations play no part in the research and selection process.
April 26, 2011 Bergeson & Campbell, P.C. Is a Proud Sponsor of CHEMCON ASIA 2011 and Leslie MacDougall Will Speak on Global Chemical Initiatives
Bergeson & Campbell, P.C. (B&C), B&C Consortia Management, L.L.C. (BCCM), The Acta Group, L.L.C. (Acta), and The Acta Group EU, Ltd (Acta EU) are pleased to announce that B&C is a proud Sponsor of CHEMCON ASIA 2011 and that Leslie MacDougall will speak, Monday, June 27, 2011, at Seminar 1 -- "Global Approach to New Chemicals" on the development of a global testing program, including Organization for Economic Cooperation and Development (OECD) and other test protocols, and on Good Laboratory Practice (GLP) and lab certification developments. Ms. MacDougall will also speak during Session 13 -- "Chemical Control Legislation in the North American Free Trade Agreement (NAFTA)-region" on U.S. chemical control legislation and aspects of the Globally Harmonized System of Classification and Labeling (GHS). CHEMCON ASIA 2011 will be held from June 27 to July 1, 2011, in Kowloon, Hong Kong. Information on how to register is available online.
April 20, 2011 Bergeson & Campbell, P.C. To Host A Webinar On Lautenberg's Recently Reintroduced TSCA Reform Bill MAY 9, 2011 -- SAVE THE DATE
Bergeson & Campbell, P.C. (B&C), B&C Consortia Management, L.L.C. (BCCM), The Acta Group, L.L.C. (Acta), and The Acta Group EU, Ltd (Acta EU) are pleased to announce that B&C will host a webinar to discuss Senator Frank Lautenberg's (D-NJ) recently reintroduced bill to amend the Toxic Substances Control Act (TSCA), the Safe Chemicals Act of 2011, on Monday, May 9, 2011, from 1:00 p.m. to 3:00 p.m. (EDT).
This webinar will focus on the new bill, identify and discuss key differences from S. 3209, and build on B&C's September 22, 2010, webinar, which focused on TSCA reform developments to that time. Lynn L. Bergeson will moderate the panel.
Speakers include:
James V. Aidala, Senior Government Consultant, B&C;
Connie DeFord, Global Environmental, Safety, and Health Product Leader, The Dow Chemical Company;
Richard A. Denison, Ph.D., Senior Scientist, Environmental Defense Fund, Inc.;
Steven J. Goldberg, Esquire, Vice President and Associate General Counsel, BASF Corporation; and
Andy Igrejas, National Campaign Director, Safer Chemicals, Healthy Families.
Additional details will be sent under separate cover.
April 20, 2011 Lynn L. Bergeson Will Moderate Panel on International and State Regulatory Programs and Strategies for Addressing Nanoscale Materials
Bergeson & Campbell, P.C. (B&C), The Acta Group, L.L.C. (Acta), and The Acta Group EU, Ltd (Acta EU) are pleased to announce that on May 19, 2011, Lynn L. Bergeson will moderate a panel discussing key nanotechnology-related international and state regulatory programs during a "quick teleconference" program sponsored by the American Bar Association (ABA) Section of Environment, Energy, and Resources entitled Nano Governance: The Current State of Federal, State, and International Regulation. The teleconference will explore the new and creative applications of existing regulatory tools and governance approaches to address the potential risks of nanotechnologies, implement new risk assessment approaches to evolving technologies, and maximize the potential benefits of these materials.
Speakers include:
William Jordan, Senior Policy Advisor, Office of Pesticide Programs, U.S. Environmental Protection Agency (EPA);
Jim Alwood, Program Manager, Chemical Control Division, Office of Pollution Prevention and Toxics, EPA;
Treye A. Thomas, Ph.D., Toxicologist, Directorate for Health Sciences, U.S. Consumer Product Safety Commission;
Neena Sahasrabudhe, Ph.D., Office of Pollution Prevention and Green Technology, California Department of Toxic Substances Control;
Rosalind Volpe, Ph.D., Executive Director, Silver Nanotechnology Working Group, A Program of Silver Research Consortium, LLC;
Thomas R. Jacob, Coordinator, California Nanotechnology Initiative;
Richard A. Denison, Ph.D., Senior Scientist, Environmental Defense Fund, Inc.; and
Steve Froggett, Ph.D., Froggett & Associates.
There are two ways to participate in this program, either attending a host site location or individual dial-in. Participation at a host site location is free of charge for ABA members and $110 for non-members. Registration with the host site contact is required, however:
Durham, North Carolina: Silver Research Consortium, LLC, 1822 E. NC Highway 54, Suite 120. RSVP: Rosalind Volpe, (919) 361-4647, ext. 3023 or rvolpe@caa.columbia.edu;
San Francisco, California: McKenna, Long, Aldridge, LLP, 101 California Street, 41st Floor. RSVP: Ann Grimaldi, (415) 267-4104 or agrimaldi@mckennalong.com; or
Washington, D.C.: Wiley Rein LLP, 1776 K Street, N.W. RSVP: David E. Markert, (202) 719-7496 or dmarkert@wileyrein.com.
April 4, 2011 Nanotechnology Law & Business Includes Article Co-Authored by Lynn L. Bergeson
Bergeson & Campbell, P.C. (B&C), B&C Consortia Management, L.L.C. (BCCM), The Acta Group, L.L.C. (Acta), and The Acta Group EU, Ltd (Acta EU) are pleased to announce that Nanotechnology Law & Business has published an article co-authored by Lynn L. Bergeson entitled "RoHS Recast: How Did Nanomaterials Fare?" The abstract states:
Several types of nanoscale materials recently dodged a bullet as the European Parliament declined to ban nanosilver and long multi-walled carbon nanotubes in the European Union's Directive on the Restriction and Use of Certain Hazardous Substances in Electrical and Electronic Equipment (more commonly known as "RoHS"). For reasons not entirely clear, detractors of these nanoscale materials tried, and failed, to ban them outright in the RoHS Recast initiative. For nano stakeholders, while the news is good, the process serves as a cautionary tale of the shape of things to come in forthcoming legislative initiatives in the European Union, and likely elsewhere.
The article provides a detailed overview of the history of the European Parliament's consideration of certain nanomaterials, and offers some explanation as to why these efforts failed. The article is co-authored by Ruxandra Cana of the Brussels office of Field Fisher Waterhouse, whose insights "from the field" as it were are interesting and valuable.
Reprints of the article are available upon request online.
March 25, 2011 Bergeson & Campbell, P.C. Is a Proud Sponsor of the American Bar Association's Section of Environment, Energy, and Resources' U.S. Environmental Justice and the Law Symposium
Bergeson & Campbell, P.C. (B&C), B&C Consortia Management, L.L.C. (BCCM), The Acta Group, L.L.C. (Acta), and The Acta Group EU, Ltd (Acta EU) are pleased to announce that B&C is a proud sponsor of the American Bar Association's Section of Environment, Energy, and Resources' (ABA SEER)U.S. Environmental Justice and the Law Symposium, which will be held Friday, April 1, 2011, in Oxford, Mississippi.
ABA SEER has collaborated with the University of Mississippi School of Law to present a unique symposium on the topic of environmental justice and the law. The symposium will bring together representatives of academia, government, the private bar, non-governmental organizations, and the corporate sector to discuss the evolution of efforts to address conflicts that can arise around industrial facility operations and siting and community needs. The symposium will present a brief historical overview of key legal developments and will feature a series of roundtables where experts from a variety of perspectives will discuss:
How environmental justice conversations have been successfully incorporated into facility expansion and/or siting decisions;
Advances in information availability and the role of this information in environmental justice claims and cases; and
Legal and practical responses to environmental justice concerns, and case studies in moving forward in constructive and positive ways.
The symposium will be held at the University of Mississippi School of Law. There is no charge to attend the symposium, but due to space constraints advance registration is required. Information on how to register is available online.
March 24, 2011 Jayne Bultena Joins Bergeson & Campbell, P.C. and Brings Valuable Experience to Its FDA Practice
Bergeson & Campbell, P.C. (B&C), B&C Consortia Management, L.L.C. (BCCM), The Acta Group, L.L.C. (Acta), and The Acta Group EU, Ltd (Acta EU) are pleased to announce that Jayne Bultena has joined B&C as Of Counsel. Ms. Bultena brings a distinguished background on a wide range of matters arising under the Federal Food, Drug, and Cosmetic Act. She has represented Fortune 100 companies, start-ups, and venture capital investors on several issues, including developing and implementing life-cycle management strategies using patent and non-patent (Hatch-Waxman) options, including seeking orphan drug designations; switching drug products from prescription to non-prescription status by creating novel marketing plans to address policy and regulatory concerns and preparing clients for advisory committee presentations; managing compliance risks and promotional violations, including U.S. Food and Drug Administration (FDA) inspections; responding to FDA deficiencies and warning letters; advising clients on development of claims, labeling, and promotional materials; petitioning FDA on changes in patent restoration terms, barring use of volunteers for certain clinical testing, supporting regulation of tobacco products, and clarifying orphan drug designations; and assisted clients with unique food, dietary supplement, and cosmetic products to market through appropriate regulatory pathways. In addition to representing clients before FDA, Ms. Bultena has represented clients before the Consumer Product Safety Commission and the Federal Trade Commission.
Ms. Bultena received her bachelor's degree from the University of South Dakota, magna cum laude, and her law degree from Harvard University. Most recently, Ms. Bultena was a partner in the Washington, D.C. office of Foley Hoag LLP.
March 17, 2011 Lynn L. Bergeson and James V. Aidala Will Speak at the CropLife America and RISE 2011 Spring Conference Bergeson & Campbell, P.C. (B&C), B&C Consortia Management, L.L.C. (BCCM), The Acta Group, L.L.C. (Acta), and The Acta Group EU, Ltd (Acta EU) are pleased to announce that on April 8, 2011, Lynn L. Bergeson and James V. Aidala will speak at the CropLife America and Responsible Industry for a Sound Environment (RISE) 2011 Spring Conference, "Seeking Scientific Solutions in a Regulatory Landscape," on two key issues -- the future of nanotechnology and the challenges in pesticide regulation. The conference will focus on up-to-date science and regulatory issues impacting the crop protection and specialty pesticide industries, including issues such as transparency and scientific integrity, National Pollutant Discharge Elimination System (NPDES) permitting, spray drift, the Endocrine Disruptor Screening Program (EDSP), and pesticide registration, as well as broader issues such as the role of science in the media. Speakers include representatives from the U.S. Environmental Protection Agency (EPA), the U.S. Department of Agriculture (USDA), academia, scientific communities, and industry.
The conference will be held at the Marriott Crystal Gateway in Arlington, Virginia, on April 7-8, 2011. Information on how to register for this event is available online.
March 11, 2011 Lynn L. Bergeson Will Speak at the Practising Law Institute's Program, Environmental Regulation 2011: Managing in the Face of Rapid Change
Bergeson & Campbell, P.C. (B&C), B&C Consortia Management, L.L.C. (BCCM), The Acta Group, L.L.C. (Acta), and The Acta Group EU, Ltd (Acta EU) are pleased to announce that on April 6, 2011, Lynn L. Bergeson will speak in San Francisco at the Practising Law Institute's (PLI) program, Environmental Regulation 2011: Managing in the Face of Rapid Change, on two issues -- key nanotechnology-related global legislation matters and legislative efforts by Congress on the Toxic Substances Control Act (TSCA). The program will focus on recent regulatory developments in the environmental arena and will provide insight on how corporations manage compliance in a dynamic new regulatory environment.
Speakers include, among others:
Elizabeth J. Adams, Deputy Director, Air Division, U.S. Environmental Protection Agency (EPA), Region 9;
Steven Branoff, Senior Manager, ENVIRON International Corporation;
Josephine S. Cooper, Public Affairs Consultant, Josephine Cooper LLC; Former Group Vice President of Government and Industry Affairs, Toyota Motor North America;
Amy Miller, Manager, Resource Conservation and Recovery Act (RCRA) Enforcement Office, EPA, Region 9;
Irma Russell, Dean, School of Law, The University of Montana;
Alexis Strauss, Director, Water Division, EPA, Region 9; and
March 2, 2011
Timothy J. Vandevort Joins Bergeson & Campbell, P.C.’s Consortia Management Affiliate, B&C Consortia Management, L.L.C. Mr. Vandevort Brings Valuable Experience in Consortia Management for the Chemical Business Community and Enhances B&C Consortia Management, L.L.C.’s Growing Practice
Bergeson & Campbell, P.C. (B&C) and its consortia management affiliate, B&C Consortia Management, L.L.C. (BCCM) are pleased to announce the addition of Timothy J. Vandevort to BCCM’s team. His experience in consortia management will supplement the skill sets of other BCCM professionals and enhance BCCM’s services to clients.
Mr. Vandevort previously worked for the American Chemistry Council where he was Manager for Industry Affairs for the Center for the Polyurethanes Industry (CPI). During his tenure at the American Chemistry Council, he monitored emerging issues and developed strategies to advocate the goals and objectives pertinent to CPI member companies. Mr. Vandevort managed 11 CPI committees that addressed a variety of issues, including building codes and standards, energy efficiency, combustibility, recycling and sustainability, and other technical and regulatory issues. He developed position papers, technical bulletins, and guidance materials on critical industry issues to enhance industry and protect the safety of its customers and consumers. Kathleen M. Roberts, Vice President of BCCM stated: “We are thrilled to have Jake join us at BCCM. I am certain his knowledge, talent, and energy will be an asset to our organization, and help our members achieve their goals.” Mr. Vandevort has a Bachelor of Science in Environmental Science from the University of Maryland
February 14, 2011
The February 7/14, 2011, issue of Chemical Week quotes the Acta Group regarding Senator David Vitter's (R-LA) statement concerning reform of the Toxic Substances Control Act (TSCA).
February 4, 2011 James V. Aidala and Charles M. Auer Will Speak at the Chemical Heritage Foundation's Forthcoming Event, TSCA: From Inception to Reform
Bergeson & Campbell, P.C. (B&C), B&C Consortia Management, L.L.C. (BCCM), The Acta Group, L.L.C. (Acta), and The Acta Group EU, Ltd (Acta EU) are pleased to announce that James V. Aidala and Charles M. Auer have been selected to participate in a panel discussion entitled TSCA: From Inception to Reform sponsored by the Chemical Heritage Foundation's Center for Contemporary History and Policy. As part of its oral history project, the program will focus on the Toxic Substances Control Act (TSCA) and its implementation, and feature individuals who were involved in developing the U.S. Environmental Protection Agency's (EPA) toxic substances program since its inception in 1976. This program offers an opportunity to hear first hand accounts by those who built and implemented TSCA, and gain their perspective on the law, what it has done, and whether or not it can continue to work in the 21st century.
Panelists include:
James V. Aidala, former Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances, EPA (1993-2000);
Charles M. Auer, former Director, Office of Pollution Prevention and Toxics, EPA (2002-2009);
Charles L. Elkins, former Director, Office of Toxic Substances, EPA (1987-1990);
Mark A. Greenwood, former Director, Office of Pollution Prevention and Toxics, EPA (1990-1994); and
Glenn E. Schweitzer, former Director, Office of Toxic Substances, EPA (1973-1977).
The event will be held at the American Association for the Advancement of Science, Washington, D.C., on March 3, 2011, and will run from 5:00 p.m. to 6:30 p.m., with a following reception from 6:30 p.m. to 7:30 p.m. The event is free and open to the public, but registration is required. To register, please visit online.
January 25 ABA Publishes New Book on Product Liability
We are pleased to announce that the American Bar Association (ABA) has published a new book, entitled Product Liability, which Lynn L. Bergeson co-authored. Product Liability presents business and policy advisory perspectives on issues in product liability emerging from current changing legal and global market conditions. Bergeson co-authored the chapter entitled “New on the Horizon: Nanotechnology.” More information is available online.
January 19, 2011 Lynn L. Bergeson Will Moderate Panel on International and State Regulatory Programs and Strategies for Addressing Nanoscale Materials
Bergeson & Campbell, P.C. (B&C), The Acta Group, L.L.C. (Acta), and The Acta Group EU, Ltd (Acta EU) are pleased to announce that on January 27, 2011, Lynn L. Bergeson will moderate a panel discussing key nanotechnology-related international and state regulatory programs during a "quick teleconference" program sponsored by the American Bar Association (ABA) Section of Environment, Energy, and Resources entitled Nano Governance: The Current State of Federal, State, and International Regulation. The teleconference will explore the new and creative applications of existing regulatory tools and governance approaches to address the potential risks of nanotechnologies, implement new risk assessment approaches to evolving technologies, and maximize the potential benefits of these materials.
Speakers include:
William Jordan, Senior Policy Advisor, Office of Pesticide Programs, U.S. Environmental Protection Agency (EPA);
Jim Alwood, Program Manager, Chemical Control Division, Office of Pollution Prevention and Toxics, EPA;
Treye A. Thomas, Ph.D., Toxicologist, Directorate for Health Sciences, U.S. Consumer Product Safety Commission;
Neena Sahasrabudhe, Ph.D., Office of Pollution Prevention and Green Technology, California Department of Toxic Substances Control;
Rosalind Volpe, Ph.D., Executive Director, Silver Nanotechnology Working Group, A Program of Silver Research Consortium, LLC;
Thomas R. Jacob, Government Affairs Manager, Western Region, DuPont Company;
Richard A. Denison, Ph.D., Senior Scientist, Environmental Defense Fund, Inc.; and
Steve Froggett, Ph.D., ICF International.
There are two ways to participate in this program, either attending a host site location or individual dial-in. Participation at a host site location is free of charge for ABA members and $110 for non-members. Registration with the host site contact is required, however:
Durham, North Carolina: Silver Research Consortium, LLC, 1822 E. NC Highway 54, Suite 120. RSVP: Rosalind Volpe, (919) 361-4647, ext. 3023 or rvolpe@cca.columbia.edu;
Houston, Texas: Bracewell & Giuliani, LLP, 711 Louisiana Street, Suite 2300. RSVP: Lisa M. Jaeger, (202) 828-5844 orlisa.jaeger@bracewellgiuliani.com;
San Francisco, California: McKenna, Long, Aldridge, LLP, 101 California Street, 41st Floor. RSVP: Ann Grimaldi, (415) 267-4104 or agrimaldi@mckennalong.com; or
Washington, D.C.: Wiley Rein, 1776 K Street, N.W. RSVP: David E. Market, (202) 719-7496 or dmarket@wileyrein.com.
January 5, 2011 B&C Launches Consortia Management Affiliate BERGESON & CAMPBELL, P.C., AND ITS CONSULTING AFFILIATES, THE ACTA GROUP, L.L.C. AND THE ACTA GROUP EU, LTD, ANNOUNCE THE LAUNCH OF BERGESON & CAMPBELL, P.C.’S CONSORTIA MANAGEMENT AFFILIATE, B&C CONSORTIA MANAGEMENT, L.L.C.
Bergeson & Campbell, P.C. (B&C), The Acta Group, L.L.C. (Acta), and The Acta Group EU, Ltd (Acta EU) are pleased to announce the formation and launch of B&C’s consortia management affiliate, B&C Consortia Management, L.L.C. (BCCM). BCCM provides core support services for industrial, agricultural, and biocide chemical advocacy, testing, and research consortia. BCCM provides a full compliment of consortia management services, including consortia formation, full financial services managed by a C.P.A., organizational support, administration services, and infrastructure/communication platforms to ensure consortium participants have secure access to consortia documents and operations wherever they may happen to be located. BCCM also provides effective and efficient laboratory communication and management services for consortia that expend significant resources on study data production.
BCCM structures and manages its consortia to conform with the realities of the industrial and agricultural chemical business communities, and offers a variety of state-of-the-art actual and/or virtual electronic platforms or a combination of the two to ensure consortia participants have a business organizational model that allows seamless access to and communication with the consortia and its business affairs. These services free time for consortium members to focus on substantive issues, thus helping to ensure the consortium’s interests are protected and its voice heard on a wide-range of domestic and international regulatory, scientific, legal, and related issues.
Kathleen M. Roberts, Vice President of BCCM, notes that “the need to form chemical consortia has increased greatly over the past few years. EPA has been very active in compelling the development of data. The industrial and agricultural chemical community has also looked for creative ways to leverage resources to satisfy product stewardship and related business needs. BCCM is well-suited to assist chemical manufacturers and others in fulfilling these regulatory and business needs.”
B&C, BCCM, Acta, and Acta EU lawyer and non-lawyer scientists and professionals assist clients with addressing the complex legal, regulatory, and science issues that arise at the intersection of law and science policy pertinent to traditional and nanoscale industrial, agricultural chemicals, and biocides. B&C, BCCM, Acta, and Acta EU professionals offer expertise on a full range of global chemical program consulting services that include, but are not limited to, the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the European Union’s (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation, the Restriction of Hazardous Substances (RoHS), Globally Harmonized Systems (GHS), and related global chemical regulatory programs in North America, the EU, and Asia and Pacific Rim countries.
January 4, 2011
NanoBusiness Alliance Names Lynn L. Bergeson As One of the “Most Influential Nanotechnology Leaders from 2010″
We are pleased to announce that NanoBusiness Alliance (NbA) has selected Lynn L. Bergeson as one of its “Most Influential Nanotechnology Leaders from 2010.” The NbA is the industry association for the emerging nanotechnology industry. Through its extensive network of leading start-ups, Fortune 500 companies, research institutions, non-governmental organizations, and public-private partnerships, the NbA shapes nanotechnology policy and helps accelerate the responsible commercialization of nanotechnology innovation. On July 1, 2010, the NbA issued a Position Statement on Nanomaterials Product Sustainability, which reflects its members’ “enduring commitment to managing effectively the environmental, health, and safety (EHS) implications of nanotechnology.”
The NbA states: “Lynn is one of America’s top EH&S practitioners,” and those selected “are all Nanotechnology Evangelists.” The NbA compiled this list from its year-long interview series of influential leaders in the nanotechnology community. The NbA interview is available online.
December 8, 2010 Nano Governance: The Current State of Federal, State, and International Regulation
SAVE THE DATE
January 27, 2011
1:00 – 5:30 p.m. (EST)
NANO GOVERNANCE: THE CURRENT STATE OF FEDERAL, STATE, AND INTERNATIONAL REGULATION
Please mark January 27, 2011, on your calendar for an exciting teleconference under development by the American Bar Association, Section of Environment, Energy, and Resources, Pesticides, Chemical Regulation, and Right-to-Know Committee.
Program Overview:
The Federal Regulatory Outlook
Beyond the Feds: International/State Regulatory Programs and Strategies for Addressing Nanoscale Materials (Moderated by Lynn L. Bergeson)
Perspectives from the Field
More details to follow.
December 2, 2010
NanoBusiness Alliance Interviews Lynn L. Bergeson
We are pleased to announce that the NanoBusiness Alliance included Lynn L. Bergeson in its recent interview series. The interview covers a wide range of issues related to nanotech environmental, health and safety, including such "hot" topics as establishing a nano nomenclature that is uniform, thoughtful, and useful for regulatory purposes; the U.S. Environmental Protection Agency's (EPA) three Toxic Substances Control Act (TSCA) proposals that will have an immediate and significant impact on the commercialization of nanoscale materials; and the EPA's Office of Pesticide Programs development of a policy under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) that will apply to nanopesticides. The NanoBusiness Alliance is an industry association founded to advance the emerging business of nanotechnology and microsystems for corporations, start-ups, researchers, universities, investors, and a host of other key stakeholders. The Alliance's mission is to create a collective voice for the emerging small-tech industry and develop a range of initiatives to support and strengthen the nanotechnology business community, through public policy efforts, events, research, and the creation of partnerships. The interview is available online.
November 30, 2010 Save the Date -- Endocrine Disruptor Webinar -- December 20, 2010 -- 1:30 p.m. (EST)
Bergeson & Campbell, P.C. is hosting a webinar on endocrine disruptors on December 20, 2010, at 1:30 p.m. (EST). This webinar will focus on recent developments in the area of endocrine disruptors, including the U.S. Environmental Protection Agency's (EPA) recent issuance of the second list of chemicals for Tier 1 screening, implications of the draft "weight-of evidence" and policies and procedures guidance documents, lessons learned from the first list of chemicals selected for Tier 1 screening, EPA's response to other scientifically relevant information (OSRI), and scope of testing orders, among other topics. Please save the date -- details will be sent under separate cover.
November 22, 2010 LYNN L. BERGESON WILL SPEAK ON REACH AT THE CSPA INTERNATIONAL AFFAIRS CONFERENCE
Bergeson & Campbell, P.C. (B&C), The Acta Group, L.L.C. (Acta), and The Acta Group EU, Ltd (Acta EU) are pleased to announce that Lynn L. Bergeson will speak, Saturday, December 4, 2010, about Toxic Substances Control Act (TSCA) reform legislation and the role of the European Union’s (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program at the Seventh Annual International Affairs Conference in Fort Lauderdale, Florida. Additional information is available online.
Ms. Bergeson and other B&C, Acta, and Acta EU lawyer and non-lawyer professionals assist clients with addressing the complex legal, regulatory, and science issues that arise at the intersection of law and science policy pertinent to traditional and nanoscale industrial and agricultural chemicals and biocides. B&C, Acta, and Acta EU professionals offer expertise on a full range of global chemical program consulting services that include, but are not limited to, TSCA, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EU’s REACH regulation, and related global chemical regulatory programs.
November 3, 2010 B&C Will Host ABA Quick Teleconference on FTC’s Proposed Green Guides We are pleased to announced that Lynn L. Bergeson will moderate a “quick teleconference” program sponsored by the American Bar Association (ABA) Section of Environment, Energy, and Resources entitled “Selling Green: A Concise Overview of the FTC’s Proposed Guides for the Use of Environmental Marketing Claims.” The November 16, 2010, teleconference will explore the Federal Trade Commission’s (FTC) proposed revisions to its Guides for the Use of Environmental Marketing Claims (Green Guides), consider the reasoning behind the FTC’s decision to propose them as it did, and discuss the legal, practical, and business competition issues that arise with application of the Green Guides in the real world. Speakers include:
Anne Johnson, Director, Sustainable Packaging Coalition;
Laura Koss, FTC; and
Beth L. Laws, Assistant General Counsel and Vice President for International Affairs, Consumer Specialty Product Association.
There are two ways to participate in this program, either attending a host site location or individual dial-in. Participation at a host site location is free of charge for ABA members, and $110 for non-members. Registration with the host site contact is required, however:
Austin, Texas: Brown McCarroll, L.L.P., 111 Congress Ave., Suite 1400. RSVP: Keith Hopson, (512) 479-9735 or khopson@brownmccarroll.com;
Bloomfield Hills, Michigan: Butzel Long, Stoneridge West, 41000 Woodward Ave. RSVP: Beth S. Gotthelf, (248) 258-1303 or gotthelf@butzel.com; and
Washington, D.C.: Bergeson & Campbell, P.C. (B&C), 1203 Nineteenth St., NW, Suite 300. RSVP: Chad Howlin, (202) 557-3816 or chowlin@lawbc.com.
October 26, 2010
Lynn L. Bergeson Included in The International Who's Who of Business Lawyers 2010
We are pleased to announce that Lynn L. Bergeson is included in The International Who's Who of Business Lawyers 2010. Bergeson, who is included in the breakdown of "most highly regarded individuals" in the environment category, is described as "a sought-after speaker and an 'expert in chemicals regulation.'" The publication is based on research, including conversations with private practice lawyers of international standing in the practice area in question or in related fields, as well as with general counsel. The individuals and firms they recommend are then canvassed using questionnaires. Who's Who Legal then collates the returned data with information obtained from legal and financial media and respondent corporate counsel. A preliminary listing is distributed to all lawyers who were mentioned during the research. Telephone and face-to-face interviews are conducted internationally to refine the listing to those lawyers who, by general agreement, are considered the pre-eminent lawyers in the field.
Who's Who Legal sets a high nomination threshold for inclusion in The International Who's Who of Business Lawyers. Only those lawyers who have met the independent research criteria are recommended and listed. Financial considerations play no part in the research and selection process.
October 5, 2010
LYNN L. BERGESON WILL SPEAK ON REACH AT SAINT JOSEPH'S UNIVERSITY GLOBAL CHEMICAL MANAGEMENT REGULATIONS AND COMPLIANCE MANAGEMENT SEMINAR
Bergeson & Campbell, P.C. (B&C), The Acta Group, L.L.C. (Acta), and The Acta Group EU, Ltd (Acta EU) are pleased to announce that Lynn L. Bergeson will speak, Saturday, October 23, 2010, on "Understanding the EU REACH Regulation" at the Saint Joseph's University Global Chemical Regulations and Compliance Management Seminar in Philadelphia, Pennsylvania. This seminar is open to the public. Environmental, health, and safety (EHS) professionals; product safety managers; technical and research and development professionals; and regulatory professionals are encouraged to attend. Additional information on the seminar is available online.
Ms. Bergeson, and other B&C, Acta, and Acta EU professionals, assist clients with health, safety, science policy, and related legal and regulatory aspects of nanotechnology and emerging transformative technologies, and on more traditional global chemical product approval matters. B&C, Acta, and Acta EU professionals offer expertise on a full range of global chemical program consulting services, which include, but are not limited to, the Toxic Substances Control Act (TSCA), Organization for Economic Cooperation and Development (OECD) Screening Information Data Sets (SIDS), and the European Union's (EU) Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) regulation.
Ms. Bergeson serves on a number of domestic and international nanotechnology standard setting and governance committees. She is a member of the International Organization for Standardization (ISO) Technical Committee 229 on Nanotechnologies and works on several OECD Working Party on Manufactured Nanomaterials projects. B&C's European affiliate, Acta EU, maintains an extensive REACH practice, which is busy preparing for the November 2010 registration deadline. Other topics addressed during the five-week seminar include: "Overview of U.S. Federal and Canadian National Chemical Safety" (session held October 16); and "Basics of the New U.N. Global Harmonized Systems for the Classification and Labeling of Chemicals" (session held November 6).
October 4, 2010 Environmental Quality Management “Washington Watch” Column Wins APEX Award
We are pleased to announce that Environmental Quality Management recently won the 2010 APEX Award of Excellence for Lynn L. Bergeson’s “Washington Watch” column. APEX is sponsored by Communications Concepts, Inc., which publishes Writing That Works: The Business Communications Report, a bimonthly newsletter covering business writing, editing, and publishing for communicators in corporate, nonprofit, agency, and independent settings. The APEX Awards Competition is open to communicators in corporate, nonprofit, and independent settings, including companies, freelancers, advertising and communications agencies, associations, national, regional, state/provincial, city, and local government agencies, and other public and private institutions.
September 30, 2010 Lynn L. Bergeson Will Speak On Nanotechnology Issues and Moderate Panel On Global Initiatives at CHEMCON THE AMERICAS 2010
Bergeson & Campbell, P.C. (B&C), The Acta Group, L.L.C. (Acta), and The Acta Group EU, Ltd (Acta EU) are pleased to announce that B&C is a proud Sponsor of CHEMCON THE AMERICAS 2010 and that Lynn L. Bergeson will speak, Wednesday, November 10, 2010, at Session 7 — “Similarities and Differences in Global Legislation” about developments and emerging issues on nanotechnology. Ms. Bergeson will also moderate a panel during Session 11 — “Global Initiatives,” which will consider international regulatory initiatives at the CHEMCON THE AMERICAS 2010 Conference in Philadelphia, Pennsylvania.
B&C has made a concerted effort to be in the forefront of the science policy debate involving nanotechnologies and other emerging technologies. Ms. Bergeson, and other professionals at B&C, counsel clients on health, safety, science policy, and related legal and regulatory aspects of nanotechnology and emerging transformative technologies, and on more traditional chemical product approval matters. B&C professionals offer expertise on a full range of global chemical program consulting services, which include, but are not limited to, the Toxic Substances Control Act (TSCA), Organization for Economic Cooperation and Development (OECD) Screening Information Data Sets (SIDS), and the European Union’s (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation.
Ms. Bergeson serves on a number of domestic and international nanotechnology standard setting and governance committees. She is a member of the International Organization for Standardization (ISO) Technical Committee 229 on Nanotechnologies and works on several OECD Working Party on Manufactured Nanomaterials projects. In 2005 and 2006, Ms. Bergeson served as Chair of the American Bar Association (ABA) Section of Environment, Energy, and Resources, and serves in other ABA leadership positions. She led the Section’s efforts to identify the legal authority available to the federal government to regulate nanotechnology under existing federal statutes and other legal authorities, and continues to work extensively on the Section’s nano projects. Seeonline. Recent publications include: FIFRA Scientific Advisory Panel (SAP) Considers Nanosilver, Environmental Law Reporter (2009); Nanotechnology: Environmental Law, Policy, and Business Considerations, ABA (2009); Nanotechnology and the Environment, CRC Press (2008) (co-author); Nanotechnology Deskbook, ELI (2007) (co-author); TSCA and Engineered Nanoscale Substances, Nanotechnology Law and Business (2007) (co-author); The Nanotechnology-Biology Interface: Exploring Models for Oversight, Center for Science, Technology & Public Policy, University of Minnesota (2006) (co-author); Pesticides, Chemical Regulation, and Right-to-Know: 2005 Annual Report — The Risks and Benefits of Nanoscale Materials, in Environment, Energy, and Resources Law: The Year in Review 2005, ABA (2005); Selected Challenges in Applying Toxicogenomic Data in Federal Regulatory Settings, Proceedings of Workshop on Genetics and Environmental Regulation (2005) (co-author); Pesticides, Chemical Regulation, and Right-to-Know: 2004 Annual Report in Environment, Energy, and Resources Law: The Year in Review 2004, ABA (2004); The RCRA Practice Manual, ABA (2004); The TSCA Basic Practice Book, ABA (2000); and The FIFRA Basic Practice Book, ABA (2000).
September 20, 2010 U.S. News - Best Lawyers "Best Law Firms" Includes Bergeson & Campbell, P.C. in First Tier
We are pleased to announce that Bergeson & Campbell, P.C. is included in the first tier of the U.S. News - Best Lawyers "Best Law Firms" rankings for environmental law in Washington, D.C. The methodology for the "Best Law Firms" involved surveying thousands of law firm clients, leading lawyers and law firm managers, partners, and associates, and marketing officers and recruiting officers. The survey asked what factors they considered vital for clients hiring law firms, for lawyers choosing a firm to refer a legal matter to, and for lawyers seeking employment. Based on the responses, six additional surveys were created, including a client survey sent to 52,480 clients, and a lawyer survey sent to 43,900 lawyers, including every U.S. lawyer listed in Best Lawyers. The client and lawyer surveys collected mostly reputational data: clients voted on expertise, responsiveness, understanding of a business and its needs, cost-effectiveness, civility, and whether they would refer another client to a firm, while lawyers voted on expertise, responsiveness, integrity, cost-effectiveness, and whether they would refer a matter to a firm and whether they consider a firm a worthy competitor. U.S. News - Best Lawyers combined all of the quantitative and qualitative data into an overall score for each firm. Firms with the highest overall scores were included on metropolitan lists that cover as many as 81 practice areas in 171 metropolitan areas and 7 states and national lists covering 39 practice areas. U.S. News - Best Lawyers states that, because firms were often separated by small or insignificant differences in overall score, they have been tiered rather than ranked sequentially.
September 8, 2010 R. David Peveler, Ph.D., Joins Bergeson & Campbell, P.C. and Its Consulting Affiliates, The Acta Group, L.L.C. and The Acta Group EU, Ltd Dr. Peveler’s Extensive and Diverse Experience in Domestic and Canadian Regulatory Matters Enhances B&C’s and Its Affiliates’ Growing International Chemical Industry Practice Areas
Bergeson & Campbell, P.C. is pleased to announce that R. David Peveler, Ph.D. joined the firm’s practice, and that of its consulting affiliates The Acta Group, L.L.C. and The Acta Group EU, Ltd on September 1, 2010. Most recently, Dr. Peveler served as a consultant to Evonik Degussa Corporation and managed a variety of product regulatory compliance matters under the Toxic Substances Control Act (TSCA), the Federal Food, Drug, and Cosmetic Act (FFDCA), and related chemical product laws and regulatory programs with special emphasis on Food and Drug Administration (FDA) regulations around bulk Active Pharmaceutical Ingredients, including Drug Master Files, Drug Establishment Registrations, Drug Product Listings, labeling, and import requirements. Prior to his work with Evonik Degussa, Dr. Peveler was a Senior Regulatory Scientist with Chemtura Corporation, where he managed TSCA and Canadian Domestic Substance List (DSL) issues and chemistries, ranging from mineral oils to complex reaction products, a wide variety of FFDCA direct and indirect food contact matters, and U.S. Department of Transportation (DOT) classification and training issues. Previously, Dr. Peveler was Witco Corporation’s, Chemtura’s predecessor in interest, R&D Group Leader where he directed a group of researchers in a variety of areas involving heat stabilizers and polymeric plasticizers.
Dr. Peveler’s many areas of expertise include domestic and Canadian product regulatory compliance, FFDCA food contact and packaging matters, Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) product registration and labeling matters, and DOT classification and labeling issues. Dr. Peveler obtained his Ph.D. in organic chemistry from Northwestern University, completed a post-doctoral Fellowship at the University of Maine, and obtained his M.B.A. at Rutgers University.
September 7, 2010 Law360 Selects Lynn L. Bergeson for "Most Admired" Series
We are pleased to announce that Law360 has selected Lynn L. Bergeson as one of its Five Most Admired Environmental Attorneys. Law360 states: "No one knows the ins and outs of chemical product approval like Bergeson & Campbell PC co-founder Lynn Bergeson, and her unrivaled command of the field's cutting edge makes her one of the most sought-after chemical regulatory lawyers in the nation." For its "Most Admired" series, Law360 invited readers to nominate attorneys they admire to be profiled. Law360 asked: "Is there an attorney you've argued against in court who you respect -- or whose briefs you fear? What about a lawyer whose views on the latest hot-button issues you eagerly seek out? Or a former classmate who is practicing the law in novel ways?" Survey participants were not permitted to nominate attorneys from their own firms, and Law360 did not consider submissions from public relations or marketing professionals. Law360 separately sought out nominations from practice group heads at the 100 largest law firms in the U.S. In total, Law360 received 1,016 nominations, which were then reviewed by a board comprising experienced lawyers and Law360 editorial staff. The Law360 profile is available online.
July 2, 2010 Final Nano Summit White Paper Released
Lynn L. Bergeson Collaborated on the White Paper
We are pleased to announce the release of the final white paper from the October 8-9, 2009, summit entitled “Environmentally Responsible Development of Nanotechnology,” which was held by The Research Triangle Environmental Health Collaborative. The charge for summit attendees was to explore issues regarding potential risk across nano-enabled product lifecycles, with the goal of generating a set of recommendations for North Carolina businesses regarding how to address such risks. The White Paper, to which Lynn L. Bergeson contributed, summarizes near-term recommendations resulting from the summit, as well as questions that should be considered in the interim to arrive at more solid long-term recommendations. The White Paper is available online.
The collective concerns of the summit participants focused on the simultaneous yet interdependent development of the industry, the need for data concerning the potential environmental and human health risks of engineered nanomaterials, and the application of existing and future regulation to protect human health and the environment. During the summit, three working groups worked in parallel, each focusing on a particular phase of the nanomaterial lifecycle to identify business needs and knowledge gaps as to each lifecycle phase. Each of the three groups — Nanomaterials Fabrication, Nanomaterials Integration into Products, and Nanomaterials Disposal and End of Life (EOL) Issues — generated detailed recommendations tailored to that particular lifecycle phase. Consensus developed that, across the lifecycle, some meta-level needs must be addressed to enable the more detailed recommendations to be carried out. The White Paper presents these overarching recommendations, called preliminary recommendations, which assist nanotech businesses in developing and commercializing products of nanotechnology in environmentally responsible ways. In addition, regulatory bodies, research communities, and supporting services may also find the recommendations to be helpful.
The recommendations focus around organizing a nanotech community to facilitate the iterative identification, development, and dissemination of nanotech safety and risk information among interested parties. Unlike most other nanomaterial safety and environmental risk meetings, which have resulted in a wish list of data that must be completed and questions that must be answered before conclusions can be drawn, the summit generated specific calls for action from targeted groups, focusing on informing current strategies for mitigating risks that can only be fully understood in the future.
June 29, 2010 Industry Urged To Step Up Nano Testing Research To Adapt NRC's "Vision"
The June 29, 2010, issue of Inside EPA's Risk Policy Report quotes Lynn L. Bergeson regarding the need for industry officials in the nanomaterials sector to "act proactively" to address nanomaterials-related research needs and adapt the National Research Council's vision to achieve the goals of its plan.
May 20, 2010 Acta EU Will Participate in REACH Seminar
We are pleased to announce that Kevin N. Goulden and Leslie S. MacDougall of The Acta Group EU, Ltd (Acta EU) will address technical and regulatory issues at the June 1, 2010, Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) seminar entitled "Outstanding Issues Before the 1st December 2010 Registration Deadline." The seminar, which will be held at Field Fisher Waterhouse LLP, in Brussels, Belgium, will address questions related to the December 1, 2010, registration deadline, on issues such as recent documents from the European Chemicals Agency/European Commission/Caracal meetings; submission of registration dossiers; Substance Information Exchange Forums/consortia-related issues; and classification and labeling. Participation in the seminar is free. The agenda is available online. Registrations are due May 27, 2010, and should be sent to brusselsevents@ffw.com.
March 26, 2010 Lynn L. Bergeson Participates in Public Forum about the Emerging Field of Nanotechnology
On April 3, 2010, the Lemelson Center for Study of Invention and Innovation, with support from the Nanoscale Informal Science Education Network (NISE Net), will host a public forum about the emerging field of nanotechnology. Lynn L. Bergeson is among the panel of experts that will provide an introduction to nanotechnology.
March 25, 2010 Strategic Alliance with ENTRIX, Incorporated
Alliance Will Strengthen Acta’s and Acta EU’s Ability to Provide REACH and Related Chemical Management Services
Bergeson & Campbell, P.C. (B&C), The Acta Group, L.L.C. (Acta), and The Acta Group EU, Ltd (Acta EU) are pleased to announce each has entered into a strategic alliance with ENTRIX, Incorporated (ENTRIX), one of the largest scientific environmental and natural resource management consulting firms in the United States. The alliance will provide additional scientific depth and capacity to strengthen B&C, Acta, and Acta EU’s ability to deliver targeted and strategic services related to the European Union’s (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation, and supplement related domestic and international chemical management services. It will also expand current capabilities to other areas such as evaluation of client vulnerabilities to “Authorization” under REACH, development of “Green Chemistry” strategies, and the design of chemical risk assessments/risk management practices in support of Product Stewardship programs.
ENTRIX is recognized as a premier scientific firm in the field of environmental risk assessment, ecotoxicology, and human health toxicology. ENTRIX has expanded its significant scientific strength to providing clients with support in the area of Product Safety and Compliance. The firm has also expanded its expertise by adding seasoned scientists from the chemical industry with direct experience in REACH implementation, product stewardship, and advocacy support on chemical policy at the state, national, and international levels. This includes a team of doctorate level scientists in the fields of chemistry, toxicology, risk assessment, environmental toxicology, and environmental chemistry, as well as experts in the Globally Harmonized System (GHS) for classification and labeling.
Members of the ENTRIX team were actively involved in REACH advocacy and leading chemical company implementation of REACH. They were also involved in the development of the United Nations (UN) Strategic Approach to International Chemicals Management (SAICM), the California Green Chemistry Initiative, and were leading members in the design and implementation of the Global Product Strategy (GPS) at the International Council of Chemical Associations (ICCA). Acta and Acta EU are leading international specialists in and work closely with B&C on chemical product approval, support, and regulatory defense. ENTRIX scientists are positioned to support Acta and Acta EU by providing additional scientific strength and technical capacity.
The combined expertise of B&C, Acta, Acta EU, and ENTRIX will offer a full range of global chemical program consulting services, which include, but are not limited to:
EU REACH;
EU Biocides Directive;
EU Classification, Labeling and Packaging (CLP) Directive;
U.S. Toxic Substances Control Act (TSCA);
U.S. Occupational Safety and Health Administration (OSHA) Hazard Communication Standard (HCS);
Globally Harmonized System (GHS);
Organization for Economic Cooperation and Development (OECD) Screening Information Data Sets (SIDS);
ICCA Global Product Strategy (GPS);
Product Stewardship under Responsible Care®;
Green Chemistry Initiatives;
Endocrine Disruptor Screening and Assessments; and
United Nations SAICM.
About The Acta Group, L.L.C. and The Acta Group EU, Ltd: Acta and Acta EU are consulting firms established to control the spiraling costs and inefficiencies encountered by clients seeking approvals to market agricultural and industrial chemicals, products of biotechnology and nanotechnology, and Food and Drug Administration-regulated products. Acta and Acta EU manage products from concept to approval, utilizing the skills and experience of professionals who have worked in the specific product areas in government and industry. Additional information is available online.
About Bergeson & Campbell, P.C.: Located in Washington, D.C., B&C is a law firm focusing on conventional and nanoscale industrial, agricultural, and specialty chemical and medical device, product approval and regulation, product defense, and associated business issues. Clients are involved in many businesses, including conventional and nanoscale basic, specialty, and agricultural and antimicrobial chemicals; biotechnology, nanotechnology, and emerging transformative technologies; pharmaceuticals, medical devices, and diagnostic products; fibers; paints and coatings; printing and publishing; and plastic products. Additional information is available online.
About ENTRIX, Incorporated: ENTRIX is an international environmental and natural resource management consulting firm with 40 offices throughout North and South America. Headquartered in Houston, Texas, and founded in 1984, ENTRIX has been serving chemical manufacturers and consumer product, crop protection, and specialty chemical companies, as well as other commercial and public sector clients, for over 25 years. ENTRIX has grown to be a highly respected consulting firm widely recognized for its high-caliber, multidisciplinary scientific and strategic planning expertise. Additional information is available online.
March 4, 2010 EPA, Industry Wrestling With Scientific, Other Questions Affecting Endocrine Program
The March 4, 2010, issue of BNA Daily Environment Report quotes Jim Aidala, who participated in the American Bar Association's March 3, 2010, teleconference on endocrine disruptors.
March 4, 2010 Industry Fears New EPA Chemical Testing Approach May Stymie Input
The March 3, 2010, issue of InsideEPA.com's Toxics Regulation News quotes Bergeson & Campbell, P.C.'sFebruary 22, 2010, memorandum regarding the effects of the U.S. Environmental Protection Agency's proposed amendments to the enforceable consent agreement procedures under Section 4 of the Toxic Substances Control Act.
February 26, 2010 Lynn L. Bergeson Will Speak at Conference Concerning Environmental Regulation and Commercial Implications
We are pleased to announce that Lynn L. Bergeson will be speaking at the upcoming conference entitled “Environmental Regulation and Commercial Implications 2010: How the New Administration, Congress and the Courts Have Changed the Rules.” The conference will be held in New York City on May 7, 2010, and in San Francisco on May 18, 2010. The conference will be broadcast live on the Internet on May 7, 2010. Since the election of President Barack Obama and the 111th Congress, new environmental laws have been enacted, new environmental regulations have been promulgated, and courts have issued precedent-setting environmental decisions. Environmental law practitioners, governmental officials, and environmental consultants will offer practical advice on the implications of the new world of environmental regulation. Bergeson will speak about regulatory developments, including nanotechnology regulation and Toxic Substances Control Act reform. More information is available online.
February 25, 2010 ALI-ABA Will Hold Course on Chemical Control Law and Policy: Bergeson & Campbell, P.C. Professionals to Participate
On April 16, 2010, the American Law Institute (ALI) and American Bar Association (ABA) will hold an advanced one-day course of study on chemical control law and policy. The course will examine what practitioners need to know about the growing significance of industrial and pesticide chemical control law and regulation, providing updates on the Toxic Substances Control Act (TSCA), Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and enforcement priorities for 2010, and a roundup on significant litigation. The course will also include an integrated look at modern-day chemical control, including chemical legislation to watch, partners in pesticide and chemical regulation and management, and other hot topics. Faculty includes James V. Aidala, Charles M. Auer, and Lynn L. Bergeson. More information is available online.
February 22, 2010
Bergeson & Campbell, P.C. to Participate in ABA Quick Teleconference on Endocrine Disruptors Bergeson & Campbell, P.C. (B&C) is pleased to announce it will moderate and participate in an American Bar Association Quick Teleconference entitled "Endocrine Disruptors: The Art, Law, and Science of Responding to Testing Orders," on March 3, 2010, at 12:00 p.m. (EST). Speakers include: James V. Aidala, B&C; David Berol, U.S. Environmental Protection Agency (EPA); James C. Lamb, Ph.D., Exponent; and Robert G. Perlis, EPA. Register for the teleconference online.
February 18, 2010 Nanoparticles Block UV Rays and Stop Mold, but "the Environment Is the Guinea Pig"
In a February 18, 2010, Politics Daily article, Lynn L. Bergeson commented on regulations being developed by the U.S. Environmental Protection Agency (EPA) that would increase reporting of nanomaterial products. Bergeson stated that she expects EPA to propose that businesses provide data only for new products, and that those on the market would be grandfathered in.
February 18, 2010 Bergeson & Campbell, P.C. is a Proud Sponsor of the 2010 Global Chemical Regulations Conference Bergeson & Campbell, P.C. is pleased to announce its sponsorship of the American Chemistry Council (ACC) and the Society of Chemical Manufacturers and Affiliates’ (SOCMA) Global Chemical Regulations Conference and Exhibition being held in Baltimore, Maryland, on March 29-31, 2010.
For more than 20 years, the Global Chemical Regulations Conference has provided a unique educational opportunity for chemical industry professionals. Participation in this conference provides attendees with information and interaction with experts on the U.S. Toxic Substances Control Act (TSCA), emerging issues and trends in the product stewardship arena, and equivalent international regulations.
Bergeson & Campbell, P.C. is proud to sponsor the Global Chemical Regulations Conference because it offers a unique forum for meeting with key decisionmakers in the international chemical industry. This year’s program includes top U.S. Environmental Protection Agency (EPA) decisionmakers, Congressional leaders, internationally recognized experts on chemical regulatory and policy matters, and other leaders in the global chemical industry.
This year, interactive sessions cover key information relating to important developments on the modernization of TSCA, EPA activities, trends in global chemicals management programs, and more.
To learn more about the conference agenda and to register, please visit online.
February 16, 2010 Christopher R. Bryant Joins Bergeson & Campbell, P.C. Law Firm and The ACTA Group, L.L.C. and The ACTA Group EU, LTD Consulting Practices Mr. Bryant Brings Extensive Experience in Environmental, Health, and Safety Compliance Issues and Related Legislative, Regulatory, and Policy Issues Christopher R. Bryant, previously with the American Chemistry Council, has joined Bergeson & Campbell, P.C. and its consulting affiliates, The Acta Group, L.L.C. (Acta) and The Acta Group EU, Ltd (Acta EU). Mr. Bryant has over 20 years of experience in environmental, health, and safety (EHS) compliance and legislative, regulatory, and policy issues. Mr. Bryant was the Managing Director of the Chemical Products and Technology Division at the American Chemistry Council where he directed strategic efforts on a wide range of issues to support the U.S. chemical industry, including federal and state legislative activities, product de-selection, and advocacy with the U.S. Environmental Protection Agency (EPA) and state environmental and consumer health agencies. Prior to his tenure at the American Chemistry Council, Mr. Bryant consulted for major U.S. and international corporations on EHS matters. He assisted in the implementation of corporate-wide EHS management systems. He conducted EHS management system training sessions for business leaders. Mr. Bryant also conducted audits, operating reviews, and management system reviews at company facilities. Additionally, he provided regulatory consulting on hazardous waste, hazardous materials transportation, clean air, and Occupational Safety and Health Administration (OSHA) regulatory programs. Mr. Bryant was formerly President of The Technical Group, LLC, which specialized in hazardous substance and OSHA matters. He was the Director of EPA’s Resource Conservation and Recovery Act (RCRA)/Superfund Industrial Assistance Hotline and a field chemist with GSX Services, Inc.
February 9, 2010 Advisory Panel's Advice on Nanosilver Raises Concerns Over Possible EPA Response
In the February 9, 2010, issue of BNA Daily Environment Report, Lynn L. Bergeson states that the recommendations from the U.S. Environmental Protection Agency's (EPA) Scientific Advisory Panel (SAP) create regulatory uncertainty, which will discourage companies hoping to enter the antimicrobial market for products containing nanosilver and other nanoscale metals. According to Bergeson, while SAP's recommendations urge EPA to obtain additional information on nanosilver before granting new registrations, SAP did not address how EPA should handle existing registrations for pesticide products, which will create regulatory uncertainty for companies that already have registrations containing nanoscale silver and for those seeking approval of new registrations.
February 3, 2010 Ruth Downes, Kevin Goulden, and Tabitha Harrison Join Bergeson & Campbell, P.C.’s Affiliate, The ACTA Group EU, Ltd Each Brings Extensive Experience in International Chemical Regulatory Issues
The Acta Group EU, Ltd (Acta EU) is pleased to announce the addition of Ruth Downes, Kevin Goulden, and Tabitha Harrison to its European Union consulting practice. Their combined extensive knowledge of international chemical and health and safety regulatory programs will supplement the skill sets of other Acta EU professionals.
Ms. Downes specializes in Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) registrations and worldwide notifications, having registered many substances under REACH since 2008. Ms. Downes is experienced with the European Chemicals Agency (ECHA) submission tools such as REACH-IT and the dossier creation tool IUCLID 5 (International Uniform Chemical Information Database), including its plug-in tools such as the Chemical Safety Report (CSR) tool and the Technical Completeness Check (TCC) tool. Through the Notification of New Substances (NONS) scheme and REACH, Ms. Downes has built strong links with national competent authorities and communicates frequently with ECHA. She has worked as part of many Substance Information Exchange Forums (SIEF) and consortia supporting Lead Registrants in document preparation along with other activities to meet REACH-related registration deadlines. Ms. Downes is a former Regulatory Affairs Associate at Harlan Laboratories Ltd (formerly Safepharm Laboratories) where she provided regulatory advice and produced regulatory dossiers and documents for REACH and worldwide notifications.
Mr. Goulden has worked for many years in the chemical industry in the United Kingdom in quality control and plant supervision before gaining National Examination Board in Occupational Safety and Health (NEBOSH) certification and moving into the field of occupational health and safety in 1993, which involved all aspects of safety management from legislation compliance to operational safety. Mr. Goulden is a trained lead auditor for Occupational Health and Safety Assessment Series (OHSAS) 18001 and successfully managed the implementation of a system accredited under the International Organization for Standardization (ISO) 9001 and ISO 14000. While at Houghton, PLC, Mr. Goulden headed European decision-making groups involved in REACH regulation, Globally Harmonized System of Classification and Labelling of Chemicals (GHS), and other European regulations. He also served as past Chair, United Kingdom Lubricants Association Metal Working Fluid Product Stewardship Group, which was heavily involved in safety and environmental matters regarding supply and use of chemicals, and worked closely with the Health and Safety Executive and the Environment Agency on projects related to lubricants and metal working fluids. Additionally, he was the project lead for the production of the Metal Working Fluid Guidance DVD. Mr. Goulden has also been responsible for classification of chemicals and generation of Material Safety Data Sheets and has many years of experience as an appointed Dangerous Goods Safety Advisor. Mr. Goulden is also a member of the Institution of Occupational Safety and Health (IOSH) and has a degree in mathematics and computing.
Ms. Harrison worked as a Senior Chemist for Lubrizol in development, evaluation, and scale-up of chemical processes for new and existing products to establish or improve manufacturing capability for multi-national companies. Ms. Harrison was engaged in day-to-day refinements and tests on processes used for production of lubricants, metalworking fluids, and other engineering formulations. She has extensive experience in highlighting quality control issues using rheology, viscosity, and infrared spectroscopy testing. In addition, she has experience in formulating coating systems for multi-national companies. Ms. Harrison has experience in assisting clients with REACH-related activities, particularly in the areas of physical chemical properties and downstream user communication. Ms. Harrison has a Bachelor of Science in Chemistry from the University of Manchester Institute of Science and Technology.
January 27, 2010 Obama to Announce Spending Freeze; Effect on Environmental Programs Uncertain
In the January 27, 2010, issue of BNA Daily Environment Report, Lynn L. Bergeson states that U.S. Environmental Protection Agency Office of Pollution, Prevention, and Toxics staff members "have expressed confidence that the important initiatives under way will be continued to be funded."
January 22, 2010 Transparency, Registration Review Among EPA's Top Pesticide Issues for 2010
The January 22, 2010, issue of Daily Environment Report references Bergeson & Campbell, P.C.'s January 7, 2010, memorandum regarding its 2010 predictions.
January 22, 2010 TSCA Reform Debate, Increased EPA Scrutiny Of Chemicals Predicted Throughout 2010
The January 22, 2010, issue of BNA Daily Environment Report quotes Lynn L. Bergeson regarding the promulgation of a general significant new use rule for nanoscale chemical substances. According to Bergeson, it “has appeal as it would obviate the need for a TSCA Section 8(a) rule and avoid the small business exemption.” Bergeson also commented on nanomaterial developments expected in 2010.
January 8, 2010 Comment Period on Proposed Nanotube Rule Extended Following European Trade Request
The January 8, 2010, issue of BNA Daily Environment Report quotes Charles Auer regarding the request from the European Economic Community's World Trade Organization Technical Barriers to Trade Inquiry Point to extend the comment period on a proposed significant new use rule for two carbon nanotubes.
January 5, 2010 US EPA Hits Phthalates in First Set of Chemical Action Plans
In the January 5, 2010, issue of Chemical Watch, Lynn L. Bergeson describes the U.S. Environmental Protection Agency's chemical action plans as "breathtaking in scope." According to Bergeson, the fact that the Office of Management and Budget reviewed the action plans "portends potentially great and largely unfettered EPA activity in the months to come."
January 5, 2010 Plans for High-Concern Chemicals Show EPA Is ‘Very Ambitious,’ Has White House Backing
The January 5, 2010, issue of BNA Daily Environment Report quotes Charles Auer and Bergeson & Campbell, P.C.'s (B&C) December 31, 2009, memorandum regarding the action plans announced by the U.S. Environmental Protection Agency (EPA) on December 30, 2009. Auer described the action plans as "very ambitious" and noted that it remains to be seen whether EPA will have the staff and other resources to be as ambitious as it wants to be. In its memorandum, B&C stated: “EPA has never previously announced so many actions under the Toxic Substances Control Act, nor has it ever cited use of Section 6 so widely." The fact that OMB approved these plans “is significant and portends potentially great and largely unfettered EPA activity in the months to come."
November 30, 2009 EU Council Adopts Cosmetics Regulation, Mandates Labeling of Nanoscale Ingredients
The November 30, 2009, issue of BNA Daily Environment Report quotes Lynn L. Bergeson regarding the cosmetics regulation recently adopted by the European Union Council. The regulation would require that manufacturers label products that include nanomaterials. According to Bergeson, consumer confidence and a manufacturer's brand name could be harmed if the word “nano" is disclosed with incorrect or no context.
November 26, 2009 Acta EU Moves Office
The Acta Group EU, Ltd (Acta EU) is pleased to announce that it relocated its offices on November 26, 2009. Please update your records with Acta EU's new address, phone numbers, and fax number below. There will be no change in the e-mail address.
The Acta Group EU, Ltd
Avanta Royal Mills
17 Redhill Street
Ancoats Urban Village
Manchester, M4 5BA, UK
+44 (0) 1612164260 (main number)
November 24, 2009 EU Chemicals Agency to Provide Registrants with Specifics When Rejecting Data Dossiers
The November 23, 2009, issue of BNA Daily Environment Report reports on the September 16, 2009, appeal against a decision of the European Chemicals Agency (ECHA). Field Fisher Waterhouse (FFW), with and relying on the advice and assistance of The Acta Group EU, Ltd (Acta EU), an affiliate of Bergeson & Campbell, P.C., submitted the appeal. On the basis of this submission, on October 14, 2009, ECHA rectified the contested decision pursuant to Article 93(1) of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation.
November 23, 2009
Lynn L. Bergeson Included in Washingtonian’s List of Top Lawyers
We are pleased to announce that Lynn L. Bergeson is included on the list of top environmental lawyers in the feature on top lawyers in the December 2009 issue of Washingtonian. Washingtonian compiled its list of top lawyers relying heavily on peer recommendations, asking attorneys who was setting the standard in his or her field. Washingtonian’s list of the 800 top lawyers in 29 legal specialties represents the top one percent of lawyers in D.C.
November 18, 2009 First Appeal Filed with ECHA Board of Appeal Results in Rectification of ECHA Decision
On September 16, 2009, Field Fisher Waterhouse (FFW), with and relying on the advice and assistance of The Acta Group EU, Ltd (Acta EU), an affiliate of Bergeson & Campbell, P.C., submitted the first appeal against a decision of the European Chemicals Agency (ECHA or the Agency) with the ECHA Board of Appeal, on behalf of the registrant. On the basis of this submission, on October 14, 2009, the Executive Director of ECHA rectified the contested decision pursuant to Article 93(1) of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. By securing the rectification, FFW and Acta EU were successful in appealing a decision of the Agency, and did so in a timely and cost efficient manner for the client. ECHA’s announcement of the appeal and the appeal decision are available at http://echa.europa.eu/appeals/app_announcements_en.asp.
November 19, 2009 Joseph E. Plamondon, Ph.D. Will Speak at REACH in Practice Conference in Cologne, Germany
We are pleased to announce that Joseph E. Plamondon, Ph.D., who works for both Bergeson & Campbell, P.C. (B&C) and The Acta Group, L.L.C., a B&C consulting affiliate, will be speaking at the Sixth International Fresenius Chemicals Policy Conference: REACH in Practice, on December 7-8, 2009, in Cologne, Germany. On December 8, 2009, Dr. Plamondon will provide an update on the current status of reform of the Toxic Substances Control Act (TSCA) and address chemical nomenclature under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH). More information is available at http://www.akademie-fresenius.de/english/konferenz/output.php?thema=4&kurs=201.
November 17, 2009 Australia Seeks Comment on Proposal for Regulating Industrial Nanomaterials
The November 17, 2009, issue of BNA Daily Environment Report quotes Lynn L. Bergeson regarding Australia's proposed strategy to regulate new nanoscale chemicals and existing chemicals produced at the nanoscale. According to Bergeson, the proposal is "refreshingly thorough and comprehensive" and could serve as a model for other governments.
October 22, 2009 James V. Aidala Will Speak at Pesticide Regulation Conference
We are pleased to announce that James V. Aidala will be speaking at the November 3-4, 2009, Pesticide Regulation Conference in Crystal City, Virginia. The conference will feature keynote talks by Steve Owens, the Assistant Administrator for the U.S. Environmental Protection Agency Office of Prevention, Pesticides, and Toxic Substances, and Debbie Edwards, Director of the Office of Pesticide Programs, on their priorities for pesticide regulation under the Obama Administration. Aidala will participate in a panel on November 3, 2009, and provide industry perspectives concerning the Administration’s priorities. CropLife America and Latham & Watkins LLP are sponsoring the conference. More information is available at http://www.croplifeamerica.org/pesticide-regulation-conference-2009.
September 28, 2009 EPA Chemicals Office Needs More Resources, Former Assistant Administrators Suggest
The September 28, 2009, issue of BNA Daily Environment Report quotes James Aidala regarding the U.S. Environmental Protection Agency’s need for additional resources to address chemicals.
September 25, 2009 TSCA, Climate Top Industry’s Washington Agenda
The September 14/21, 2009, issue of Chemical Week quotes Lynn L. Bergeson regarding retailer environmental initiatives, which do not provide industry with the usual safeguards provided by regulatory initiatives.
-September 16, 2009 Former EPA Toxics Head Joins Washington Law, Consulting Firm
The September 15, 2009, issue of Risk Policy Report announces that Charles Auer, former Director of the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT), has affiliated with Bergeson & Campbell, P.C. (B&C) and its consulting affiliates, The Acta Group, L.L.C. (Acta) and The Acta Group EU, Ltd (Acta EU).
September 9, 2009 FORMER EPA OFFICIAL CHARLES M. AUER TO AFFILIATE WITH BERGESON & CAMPBELL, P.C., THE ACTA GROUP, L.L.C., AND THE ACTA GROUP EU, LTD Mr. Auer Brings Experience and Depth to Chemical and Related Environmental Regulatory and Policy Issues Charles M. Auer, former Director of the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT), Office of Prevention, Pesticides, and Toxic Substances (OPPTS), and currently President of Charles Auer & Associates, LLC, has affiliated with Bergeson & Campbell, P.C. (B&C) and its consulting affiliates, The Acta Group, L.L.C. (Acta) and The Acta Group EU, Ltd (Acta EU). Charlie Auer has a distinguished record of public service, and is well known domestically and internationally in the chemical regulatory community. Auer was Director of OPPT from September 2002 to January 2009, where he was responsible for the management and direction of the nation’s chemical and pollution prevention programs. Prior to heading OPPT, Auer was Director of the Chemical Control Division from 1992 until September 2002. Prior to that time, Auer held numerous leadership positions in what was then called the Office of Toxic Substances. Auer has an undergraduate degree in biochemistry and studied toxicology at the Massachusetts Institute of Technology. Auer offers an unparalleled breadth of experience to clients on U.S. and worldwide chemical regulatory and policy issues, both well established and emerging. Auer will assist clients in designing effective, workable solutions to difficult domestic, international, and intergovernmental chemical issues. He will focus on assisting clients in creating, developing, and successfully applying targeted, efficient solutions to complex chemical regulatory issues. His experience, particularly in applying green chemistry/safer substitute strategies, can also assist clients in efforts to develop and commercialize sustainable products and technologies, and to implement responsive and effective corporate stewardship programs.
August 26, 2009 Lynn L. Bergeson Will Speak at Conference on “Transatlantic Regulatory Cooperation: Securing the Promise of Nanotechnologies"
We are pleased to announce that Lynn L. Bergeson will be speaking at the September 10-11, 2009, international conference on “Transatlantic Regulatory Cooperation: Securing the Promise of Nanotechnologies," in London. The London School of Economics, Chatham House, the Environmental Law Institute, and the Project on Emerging Nanotechnologies at the Woodrow Wilson International Center for Scholars have spent the past year examining issues of transatlantic regulatory cooperation. During the conference, their research findings will be published in a major report, which is scheduled to be released on September 10, 2009. The conference is intended to bring together regulatory experts from the United States (US) and European Union (EU) to discuss recommendations from this research effort and to generate and examine new ideas that would enable greater transatlantic cooperation and convergence on nanotechnology oversight today and in the future. Ms. Bergeson will give a presentation on September 10, 2009, during the session on the “Scope and Limits of Self-Regulation: Voluntary and Industry Initiatives in the EU and US," which will address the future of voluntary programs and lessons from past experiences. The conference is by invitation only. Please e-mail Carmen Gayoso at nanotech@lse.ac.uk if you would like to attend. More information is available on the Internet at http://www.chathamhouse.org.uk/events/view/-/id/1217/.
August 11, 2009
Environmental Quality Management Wins APEX Award
We are pleased to announce that Environmental Quality Management recently won the 2009 APEX Award of Excellence for its “Regular Departments and Columns," including Lynn L. Bergeson’s Washington Watch column. APEX is sponsored by the editors of Writing That Works, a newsletter for communicators who write, edit, and manage business publications. The APEX Awards Competition is open to communicators in corporate, nonprofit, and independent settings, including companies, freelancers, advertising and communications agencies, associations, national, regional, state/provincial, city, and local government agencies, and other public and private institutions.
August 6, 2009
BERGESON & CAMPBELL, P.C., THE ACTA GROUP, L.L.C., AND THE ACTA GROUP EU, LTD FORM STRATEGIC ALLIANCE WITH CALEB MANAGEMENT SERVICES, LTD. Alliance Will Strengthen Acta’s and Acta EU’s Ability to Provide REACH Services
Bergeson & Campbell, P.C. (B&C), The Acta Group, L.L.C. (Acta), and The Acta Group EU, Ltd (Acta EU) are pleased to announce each has entered into a strategic alliance with Caleb Management Services, Ltd. (Caleb). The alliance will strengthen B&C, Acta, and Acta EU’s ability to provide targeted and strategic services related to the European Union’s (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. Caleb has well-recognized expertise in the field of chemicals policy, consortium management, and chemicals risk management, as well as strong policy credentials in the Montreal and Kyoto Protocol arenas. Acta and Acta EU are leading international specialists in and work closely with B&C on chemical product approval, support, and regulatory defense. The combined expertise of the four Companies will enhance the services offered by B&C, Acta, and Acta EU. Together, B&C, Acta, Acta EU, and Caleb will offer a full range of global chemical program consulting services, which include, but are not limited to, the Toxic Substances Control Act (TSCA), Organization for Economic Cooperation and Development (OECD) Screening Information Data Sets (SIDS), and REACH. Each will retain their account management responsibilities as “Only Representatives" on behalf of non-EU companies who are themselves manufacturers of substances, formulators of preparations, or producers of articles, or as “Third Party Representatives" on behalf of EU entities and data holders that wish to participate in a particular Substance Information Exchange Forum for their existing client bases. Each will, however, increasingly cooperate on the preparation and review of technical dossiers and the performance of chemical risk assessment and analysis, including, but not limited to, supply chain communication, development of exposure scenarios, socio-economic assessments, and registration services -- along with support services to manufacturers, processors, and/or users of chemical products.
July 1, 2009 Lynn L. Bergeson Will Speak at OECD Nanotechnology Conference
We are pleased to announce that Lynn L. Bergeson will be speaking during the July 15-17, 2009, Organization for Economic Cooperation and Development Conference on Potential Environmental Benefits of Nanotechnology: Fostering Safe Innovation-Led Growth. The Conference will be held in Paris, France. Bergeson will speak on July 15, 2009, during Plenary Session Two: Life Cycle Perspectives, on “Policy Considerations for an Integrated Policy Framework." Click here for more information on the Conference, including registration details.
June 9, 2009 Lynn L. Bergeson Included in The International Who’s Who of Business Lawyers 2009
We are pleased to announce that Lynn L. Bergeson has been included in The International Who’s Who of Business Lawyers 2009. Bergeson, who is included in the breakdown of “most highly regarded individuals" in the environment category, is described as “one of the finest chemicals regulation lawyers in the country." Bergeson’s practice is described as “second to none," and her litigation and compliance work are also singled out. The publication is based on research, including conversations with private practice lawyers of repute in the practice area in question or in related fields, as well as with general counsel. The individuals and firms they recommend are then canvassed using questionnaires. Who’s Who Legal then collates the returned data with information obtained from legal and financial media and respondent corporate counsel. A preliminary listing is distributed to all lawyers who were mentioned during the research. Telephone and face-to-face interviews are conducted internationally to refine the listing to a selection of between 170 and 650 lawyers who, by general agreement, are considered the pre-eminent lawyers in the field.
Who’s Who Legal sets a high nomination threshold for inclusion in The International Who’s Who of Business Lawyers. Only those lawyers who have met the independent research criteria are recommended and listed. Financial considerations play no part in the research and selection process.
April 29, 2009 Lynn L. Bergeson Included in List of Top Ten Experts in EHS Issues Related to Engineered Nanomaterials
We are pleased to announce that Lynn L. Bergeson is included in the Nanotechnology Law & Businesslist of the top ten experts in environmental, health, and safety issues related to engineered nanomaterials. Nanotechnology Law & Business states that they chose ten individuals with “substantial expertise" in EHS issues related to engineered nanomaterials and that they “expect these individuals to play leading roles in nanotechnology law and business." Nanotechnology Law & Business is a peer-reviewed journal devoted to the legal, business, and policy aspects of small scale technologies.
April 13, 2009 GRAHAM BUTTERWORTH JOINS BERGESON & CAMPBELL, P.C.’S AFFILATE, THE ACTA GROUP EU, LTD Mr. Butterworth Brings Extensive Experience in International Chemical Regulatory Issues
The Acta Group EU, Ltd (Acta EU) is pleased to announce the addition of Graham Butterworth to its European Union consulting practice. Graham’s extensive knowledge of international chemical and health and safety regulatory programs will supplement the skill sets of other Acta EU professionals. As a former Quality and Regulatory Compliance Manager of Lord Corporation, Ltd., Graham ensured company compliance with a wide range of environmental and health and safety legislation; implemented policy, manual, and procedures to implement ISO 14001 environmental accreditation and health and safety policies; implemented the ISO 9001:2000 Standard; conducted accident investigations; implemented lean manufacturing principles; and communicated with the UK Health & Safety Executive. He also successfully registered products on the IMDS database for compliance to the End-of-Life Vehicle Directive and updated all European safety data sheets to the Chemicals Hazard Information and Packaging for Supply (CHIP) regulation. Previously, Graham was with BWA Water Additives UK Ltd., where he worked extensively on Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) matters; maintained product registrations under KIWA, NSF, and Drinking Water Inspectorate (DWI) water approvals; prepared European and North American safety data sheets; and led health and safety compliance programs.
March 23, 2009 Lynn L. Bergeson Included in 2009 List of Washington, D.C. Super Lawyers
We are pleased to announce that Lynn L. Bergeson is included in the 2009 list of Washington, D.C. Super Lawyers in the specialties of environmental and administrative law. Super Lawyers employs a rigorous, multiphase process. Peer nominations and evaluations are combined with third party research. Each candidate is evaluated on 12 indicators of peer recognition and professional achievement: verdicts and settlements; transactions; representative clients; experience; honors and awards; special licenses and certifications; position within law firm; bar and or other professional activity; pro bono and community service as a lawyer; scholarly lectures and writings; education and employment background; and other outstanding achievements. Selections are made on an annual, state-by-state basis.
February 23, 2009 Kathleen M. Roberts Joins Bergeson & Campbell, P.C. and The Acta Group, L.L.C. and The Acta Group EU, LTD Consulting Practices Ms. Roberts Brings Extensive Experience in Domestic and International Science and Policy Issues and Chemical Consortia Management Kathleen M. Roberts, previously with the American Chemistry Council, has joined Bergeson & Campbell, P.C. and its consulting affiliates, The Acta Group, L.L.C. (Acta) and The Acta Group, EU, Ltd (Acta EU). Ms. Roberts has over 17 years of experience in domestic and international science and policy program management. Ms. Roberts was a Senior Director with Regulatory and Technical Affairs at the American Chemistry Council where she directed strategic efforts on improving the current chemical management system, including creation of legislative proposals, communication documents, and educational materials. To help members’ make progress with the American Chemistry Council’s product stewardship programs, Ms. Roberts developed performance measures, advocated Council policies, and provided managerial support to several action groups engaged in regulatory advocacy and public outreach activities. Ms. Roberts has served as a spokesperson for industry at national and international conferences, including the Association of International Chemical Manufacturers, ChemCon Americas, Responsible Care ® Conference, and GlobalChem Conference. As part of the CHEMSTAR (now Chemical Products and Technology Division) team, Ms. Roberts managed multiple chemical-specific groups, with individualized membership, budgets, and strategy plans, which included advocacy, research, communication, education, and litigation activities. Ms. Roberts will continue focusing on domestic and international chemical management systems, Toxic Substances Control Act reform, and related high priority chemical management issues. She will also be extensively engaged in chemical consortia management, advocacy, and public outreach. Ms. Roberts holds an undergraduate degree in Biology from the University of North Carolina, Chapel Hill.
December 16, 2008 Lynn L. Bergeson Will Speak at ABA Keystone Conference
We are pleased to announce that Lynn L. Bergeson will be speaking at the March 12-15, 2009, 38th Annual Conference on Environmental Law, held by the American Bar Association (ABA) Section of Environment, Energy, and Resources, in Keystone, Colorado. Ms. Bergeson is participating in a March 13, 2009, breakout session entitled “TSCA: Is Chemical Management Reform Needed?" More information on the Keystone conference and an advance registration form are available on the Internet at http://www.abanet.org/environ/programs/keystone/2009/home.shtml.
November 6, 2008 The Johns Hopkins University Press Publishes Genomics and Environmental Regulation
We are pleased to announce that the John Hopkins University Press has published Genomics and Environmental Regulation: Science, Ethics, and Law, which Lynn L. Bergeson co-authored. Genomics and Environmental Regulation examines the science of genomic research as applied to environmental policy. In it, the authors:
Explore environmental policy applications, including subpopulation genetic profiling, industrial regulations, and standardizing governmental evaluation of genomic data;
Assess from multiple angles the legal framework involved in applying genomics to environmental regulation;
Review closely the implications of genomic research for occupational health, from disease prevention and genetic susceptibility to toxicants, to workers’ rights and potential employment discrimination; and
Explore the bioethical and philosophical complications of bringing genetic data and research into nonclinical regulatory frameworks.
Readers of this website can receive a 20% discount on the book by using this order form.
November 5, 2008 Lynn L. Bergeson Included in 2009 Edition of Washington DC’s Best Lawyers
We are pleased to announce that Lynn L. Bergeson is included in the 2009 edition of Washington DC’s Best Lawyers in the specialty of environmental law. The list, which was published in the November 2, 2008, Washington Post, is excerpted from the 2009 edition of The Best Lawyers in America® . Best Lawyers compiles lists of outstanding attorneys by conducting exhaustive and rigorous peer-review surveys in which thousands of leading lawyers confidentially evaluate their professional peers. Best Lawyers also conducts thousands of telephone interviews with leading attorneys throughout its balloting process. Financial considerations play no part in the research and selection process.
October 9, 2008 Lynn L. Bergeson Included in 2009 Edition of The Best Lawyers in America® We are pleased to announce that Lynn L. Bergeson will be included in the 2009 edition of The Best Lawyers in America® in the specialty of environmental law, and is one of a distinguished group of attorneys who have been listed for ten years or more. Best Lawyers compiles lists of outstanding attorneys by conducting exhaustive and rigorous peer-review surveys in which thousands of leading lawyers confidentially evaluate their professional peers. Best Lawyers also conducts thousands of telephone interviews with leading attorneys throughout its balloting process. Financial considerations play no part in the research and selection process.
July 30, 2008 CRC Press Publishes Nanotechnology and the Environment
The Acta Group, L.L.C. is pleased to announce that CRC Press has published Nanotechnology and the Environment, which Lynn L. Bergeson co-authored. Nanotechnology and the Environment includes a general explanation of nanomaterials, their properties, and their uses; describes the processes used to manufacture nanoscale materials; furnishes information on the analysis of nanomaterials in the environment and their fate and transport, including the effects of wastewater treatment on nanomaterials; discusses possible risks to human health and the environment; and describes developing regulations to manage those risks. Bergeson and her co-authors:
Focus on six of the most common nanomaterials (titanium dioxide, zero valent iron, silver, carbon black, fullerenes, and carbon nanotubes) to provide a cohesive presentation of issues;
Follow those materials from their manufacture and use to their fate and transport in the environment and possible consequences of exposure;
Discuss frameworks, such as life cycle analysis, for evaluating the balance between risk and reward as nanomaterials are manufactured, used, and released to the environment; and
Describe regulations evolving around the world as a basis for regulatory compliance and control of possible risks.
Nanotechnology and the Environment may be purchased at CRC Press.
July 10, 2008
The Good, the Bad, and the Tiny
The Acta Group, L.L.C. is pleased to announce that an article in the July 2008 ABA Journal discusses the work of the American Bar Association's Section of Environment, Energy, and Resources (SEER) analyzing the legal framework for addressing issues relating to nanotechnology. Lynn L. Bergeson was Section Chair while the first phase of the "Nano Project" was completed, and leads the Section's efforts in this regard. The article discusses legal issues relating to the increasing use of nanotechnologies.
June 19, 2008 Lynn L. Bergeson Included in The Chambers USA Guide
We are pleased to announce that Lynn L. Bergeson has been included in The Chambers USA Guide for 2008. The USA Guide is based on over 14,000 in-depth interviews with clients and attorneys. Chambers & Partners then ranked the top firms and attorneys and described their merits -- often in the words of clients they interviewed. Rankings include technical legal ability, professional conduct, client service, commercial astuteness, diligence, commitment, and other qualities most valued by the client. The rankings and editorial comment about attorneys are independent and objective, and financial considerations play no part in the research process. The USA Guide states:
Environmental boutique Bergeson & Campbell PC is headed by the "unbelievably bright and astute" Lynn Bergeson, who is widely regarded as “the queen of TSCA law in DC." Her cutting-edge nanotechnology practice draws hearty praise from both clients and peers, who also commend her “tireless work ethic, passion and energy." She is well versed in legislative, regulatory and enforcement issues affecting the agrochemical industry and is also skilled at product defense.
February 11, 2008
Leslie MacDougall Joins Bergeson & Campbell, P.C. Law Firm and the ACTA Group, L.L.C. and the ACTA Group, EU, LTD Consulting Practices. Ms. MacDougall Brings Extensive Experience in Domestic and International Chemical Regulatory Issues
Leslie MacDougall, previously with the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT), has joined Bergeson & Campbell, P.C. and its consulting affiliates, The Acta Group, L.L.C. (Acta) and The Acta Group, EU, Ltd (Acta EU). Ms. MacDougall has over ten years of experience in domestic and international chemical regulatory programs. While at EPA, Ms. MacDougall was the Programs Manager for the Organization for Economic Cooperation and Development (OECD) Screening Information Data Set (SIDS) Program and the International Council of Chemical Associations (ICCA) where she functioned as the liaison for EPA, industry representatives, OECD, and OECD member country governments. Ms. MacDougall served as the U.S. representative on technical Registration, Evaluation, Authorization and Restriction of Chemicals (REACH)-related issues; served as the U.S. representative on the IUCLID User Group and harmonized templates; reviewed OECD and ICCA programmatic directives to formulate the U.S. position; and performed peer review of assessments for test plans, dossier/robust summaries, and SIDS Initial Assessment Reports for individual chemicals and categories. Ms. MacDougall performed health and environmental effects screening level assessments of existing chemicals in support of other office programs, which included: the High Production Volume Challenge Program (HPV Challenge Program), Toxic Substances Control Act (TSCA) Sections 4 and 8(e), the Risk Management 1 (RM1) process, and data evaluations on FYI submissions. After leaving EPA, Ms. MacDougall established her own regulatory consultant business, M8, Inc., where she
consulted clients on international developments in chemical management, TSCA Section 4 matters, and REACH-related issues. Ms. MacDougall holds an undergraduate degree in Environmental Health from Old Dominion University, and has completed post-graduate education in toxicology and risk assessment at the University of Maryland and Johns Hopkins University, respectively.
January 25, 2008 Preparation for REACH, State Legislation Likely to Consume Chemical Industry's Time Lynn L. Bergeson is quoted in an article in the January 23, 2008, issue of the Daily Environment Report regarding the federal and state legislative outlook for 2008.
January 18, 2008 The Challenge of Regulating Nanomaterials Lynn L. Bergeson is quoted in an article in the January 15, 2008, issue of Environmental Science & Technology regarding the U.S. Environmental Protection Agency's (EPA) clarification that nanomaterials are not considered new chemicals under the Toxic Substances Control Act (TSCA).
January 9, 2008
Environmental Quality Management Wins Apex Award
We are pleased to announce that Environmental Quality Management recently won the 2007 APEX Award of Excellence for its “Regular Departments and Columns," including Lynn L. Bergeson’s Washington Watch column. APEX is sponsored by the editors of Writing That Works, a newsletter for communicators who write, edit, and manage business publications. The APEX Awards Competition is open to communicators in corporate, nonprofit, and independent settings, including companies, freelancers, advertising and communications agencies, associations, national, regional, state/provincial, city, and local government agencies, and other public and private institutions.
January 8, 2008 Data Sought by EPA on Chemicals Nominated for Treaty on Persistent Organic Pollutants Lynn L. Bergeson is quoted in the January 7, 2008, issue of the Daily Environment Report regarding the prospects of legislation to amend the Toxic Substances Control Act (TSCA) and Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to allow the Senate to ratify the Stockholm Convention.
December 18, 2007 Comments Don't Sway EPA Decision to Cancel Organic Arsenical Herbicides
The December 17, 2007, issue of Pesticide & Toxic Chemical News quotes Lynn L. Bergeson regarding the U.S. Environmental Protection Agency's (EPA) intent to cance the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) registrations for the organic arsenicals.
November 6, 2007 ELI Publishes Nanotechnology Deskbook
We are pleased to announce that the Environmental Law Institute
(ELI) has published the Nanotechnology Deskbook, which Lynn
L. Bergeson co-authored. ELI provides the following
description of the Deskbook:
Nanotechnology promises to have far reaching impacts
on the economy, including offering technological advances
in pollution control. While over 200 products that use
nanomaterials are already in the marketplace, minimal
data exist on the health and environmental effects of
nanomaterials. This poses significant questions for
companies, regulators, consumers, and lawyers.
The Nanotechnology Deskbook guides the reader through
the application of existing law and regulations to nanomaterials
by exploring domestic laws and regulations and considering
developments in the international context. It includes
a focus on special business considerations when this
technology is involved and concludes by discussing the
development of an effective environmental governance
structure for nanotechnologies that protects human health
and the environment without stifling the development
of this new field.
November 5, 2007 Lynn L. Bergeson Included in The
International Who’s Who of Environment Lawyers 2008 We are pleased to announce
that Lynn L. Bergeson has
been included in The International Who’s Who
of Environment Lawyers 2008. Bergeson, who is included
in the breakdown of “most highly regarded individuals
-- global," is described as “one of the finest
chemicals regulation lawyers in the country." Bergeson’s
practice is described as “second to none," and
her litigation and compliance work are also singled out.
The publication is based on research, including conversations
with private practice lawyers of repute in the practice
area in question or in related fields, as well as with
general counsel. The individuals and firms they recommend
are then canvassed using questionnaires. Who’s Who
Legal then collates the returned data with information
obtained from legal and financial media and respondent
corporate counsel. A preliminary listing is distributed
to all lawyers who were mentioned during the research.
Telephone and face-to-face interviews are conducted internationally
to refine the listing to a selection of between 200 and
600 lawyers who, by general agreement, are considered
the pre-eminent lawyers in the field.
Who’s Who Legal sets a high nomination threshold
for inclusion in The International Who’s Who
of Environment Lawyers. Only those lawyers who have
met the independent research criteria are recommended
and listed. Financial considerations play no part in the
research and selection process.
October 26, 2007 Application of Four Laws to Nanotechnology
Being Studied by Bar Association Project
The October 25, 2007, issue of the Daily
Environment Report quotes Lynn
L. Bergeson regarding the Nanotechnology Project
of the American Bar Association's Section of Environment,
Energy, and Resources (SEER). In the second phase of the
Project, SEER is examining how the Food Quality Protection
Act (FQPA), Federal Food, Drug, and Cosmetic Act (FFDCA),
National Environmental Policy Act (NEPA), and the Endangered
Species Act (ESA) could be applied to nanotechnology.
August 30, 2007 Defense-Related Uses of Chemicals Have
Limited Exemptions Under REACH
The August 29, 2007, issue of the Daily
Environment Report quotes Lynn
L. Bergeson regarding the need for military contractors
to understand the defense-related uses of chemicals exempted
from the European Union's (EU) Registration, Evaluation,
and Authorization of Chemicals (REACH). Bergeson stated: "Military
applications historically and globally have been afforded
significant deference. What we may be seeing is a move to
pull back on this latitude. Under REACH, there may well
be a rebuttable presumption that chemicals are covered absent
a very compelling basis providing otherwise. The fact that
a particular application is military does not necessarily
mean what it used to under other regulatory programs."
August 27, 2007 Some see big issues in tiny technology
The August 27, 2007, issue of the National
Law Journal quotes Lynn
L. Bergeson regarding the recent report by the Food
and Drug Adminstration (FDA) Nanotechnology Task Force.
According to Bergeson, there is a need for more information
that would inform the judgment of the decision-makers within
FDA, as well as the U.S. Environmental Protection Agency.
August 1, 2007 Dr. Plamondon Will Speak at REACH Program
We are pleased
to announce that Joseph E. Plamondon,
Ph.D., who works for both Bergeson & Campbell, P.C.
(B&C) and The Acta Group, L.L.C., a B&C consulting
affiliate, will be speaking at the International Coatings
Expo (ICE) on October 4, 2007. Dr. Plamondon is participating
in a one-day program on the Registration, Evaluation,
and Authorization of Chemicals (REACH) legislation, which
took effect in the European Union on June 1, 2007. Dr.
Plamondon’s presentation is entitled “Treatment
of Confidentiality Issues under REACH and Their Impact
on the Coatings Industry." More
information on ICE and an advance registration form are
available here.
July 31, 2007 Lynn L. Bergeson Included in 2008 Edition
of The Best Lawyers in America®
We are pleased to announce that Lynn
L. Bergeson will be included in the 2008 edition of The
Best Lawyers in America® in the specialty of
Environmental Law. Best Lawyers compiles lists of outstanding
attorneys by conducting exhaustive and rigorous peer-review
surveys in which thousands of leading lawyers confidentially
evaluate their professional peers. Best Lawyers also conducts
thousands of telephone interviews with leading attorneys
throughout its balloting process. Financial considerations
play no part in the research and selection process.
July 26, 2007 Report on Nanotech Draws Quick Reaction, Calls for Additional
Resources for FDA
The July 26, 2007, issue of the Daily
Environment Report quotes
Lynn L. Bergeson regarding
the Food and Drug Administration's (FDA) Nanotechnology
Task Force's report. Bergeson notes that the report says
FDA has sufficient authority to oversee products such
as drugs and food additives, but that FDA will have a
harder time obtaining information about cosmetics and
dietary supplements, which FDA does not review before
they are sold.
July 16, 2007 EPA Proposals for Engineered Nanomaterials Spur Support,
Frustration Among Parties
The July 16, 2007, issue of the Daily
Environment Report quotes
Lynn L. Bergeson regarding
the U.S. Environmental Protection Agency's (EPA) description
of its approach to defining a new or existing nanoscale
chemical. According to Bergeson, EPA's draft proposal "is
a thoughtful, temperate, balanced approach that sets the
right tone for further discussions on these important
issues."
June 25, 2007 Lynn L. Bergeson Included in The
International Who’s
Who of Business Lawyers
We are pleased to announce that Lynn
L. Bergeson has been included in The
International Who’s Who of
Business Lawyers for 2007.
Bergeson, who is listed in the Who’s Who for the third time and is included
in the breakdown of environmental “stars" for
the second time, is described as “a real go-getter
in the chemical regulatory field." The publication
is based on research, including conversations with private
practice lawyers of repute in the practice area in question
or in related fields, as well as with general counsel.
The individuals and firms they recommend are then canvassed
using questionnaires. Who’s Who Legal then collates
the returned data with information obtained from legal
and financial media and respondent corporate counsel.
A preliminary listing is distributed to all lawyers who
were mentioned during the research. Telephone and face-to-face
interviews are conducted internationally to refine the
listing to a selection of between 100 and 500 lawyers
who, by general agreement, are considered the pre-eminent
lawyers in the field.
Who’s Who Legal sets a high nomination threshold
for inclusion in The International
Who’s Who of
Business Lawyers. Only those lawyers who have met the
independent research criteria are recommended and listed.
Financial considerations play no part in the research
and selection process.
June 6, 2007 Experts Suggest TSCA 'New Use' Rule to Define Nanotech
Universe
The June 5, 2007, issue of Inside
EPA's Risk Policy Report describes the proposal
by Lynn
L. Bergeson and Joseph
E. Plamondon to exclude nanomaterials that
essentially function like non-nanomaterials or traditional
chemicals from a significant new use rule.
June 5, 2007 Consumer Reports Says FDA Needs Authority
To Review Nanoscale Ingredient Safety Data
The June 5, 2007, issue of the Daily
Environment Report quotes Lynn
L. Bergeson regarding the nanotechnology report in
the July 2007 issue of Consumer
Reports. Bergeson states that while it might be good
if legislation mandated that manufacturers prove their products
are safe rather than having to wait for government to prove
they pose a risk, it also may be unrealistic.
May 21, 2007 Web-Based Map Identifies Organizations,
Companies Involved With Nanotechnology
The May 21, 2007, issue of the Daily
Environment Report notes that Lynn
L. Bergeson describes the interactive web-based map
developed by the Project on Emerging Nanotechnologies as
easy to use.
May 21, 2007 Environmental Group Accuses Government
of 'Gross Failure' on Nanotechnologies
The May 21, 2007, issue of Chemical
Regulation Reporter quotes Lynn
L. Bergeson regarding the Natural Resources Defense
Council's report entitled Nanotechnology's
Invisible Threat: Small Science, Big Consequences.
Bergeson said NRDC's recent contribution to the discussion
of the many benefits and potential risks is appreciated,
and raises interesting issues, many of which have been raised
before.
May 8, 2007 Rodenticide Update: What's Next?
The March 2007 issue of PCT quotes Lynn
L. Bergeson regarding the concerns of the Rodenticide
Registrants
Task Force with the U.S. Environmental Protection Agency's
proposed
rodenticide risk mitigation measures, which are "excessive,
unlawful,
lacking factual merit and, in a word, dangerous."
April 30, 2007 BERGESON & CAMPBELL, P.C. ANNOUNCES
NANOTECHNOLOGY LAW BLOG Blog Will Report U.S. and International
Regulatory and Legal Developments Involving Nanotechnologies
and Nanomaterials
Bergeson & Campbell, P.C. (B&C) is pleased to
announce that its nanotechnology law blog is now available
at http://nanotech.lawbc.com.
B&C will update its blog with weekly and more frequent
news items and documents, reporting on federal, local,
and international regulatory, legal, and policy developments
involving nanotechnologies and nanomaterials. Users may
sign up to receive e-mails of new posts to the blog at http://nanotech.lawbc.com/subscribe.html.
B&C has made a concerted effort to be in the forefront
of the science policy debate involving nanotechnologies
and other emerging technologies. Lynn
L. Bergeson counsels clients on health, safety,
science policy, and related legal and regulatory aspects
of nanotechnology and emerging transformative technologies,
and on more traditional chemical product approval matters.
Ms. Bergeson served in 2004 and 2005 on the American National
Standards Institute (ANSI) Nanotechnology Standards Panel
(NSP) Steering Committee and is now a member of the ISO
Technical Committee 229 on Nanotechnologies. Ms. Bergeson
also serves on the President’s Council of Advisors
on Science and Technology (PCAST) Nanotechnology Technical
Advisory Group (PCAST nTAG) and on the U.S. Environmental
Protection Agency’s (EPA) Steering Committee for
the Pollution Prevention through Nanotechnology Conference.
Ms. Bergeson also serves on the Executive Committee of
the Environmental Law Institute’s (ELI) Board of
Directors. Ms. Bergeson is Immediate Past Chair of the
American Bar Association (ABA) Section of Environment,
Energy, and Resources, and serves in other ABA leadership
positions and headed the Section’s efforts in 2006
to analyze the legal authority available to EPA under
existing federal environmental statutes to address potential
issues arising in connection with applications on nanotechnology.
See http://www.abanet.org/environ. Ms. Bergeson is a member
of the Converging Technologies Bar Association (CTBA),
Board of Directors and Chair of the CTBA Environmental,
Health, and Safety Committee. Recent publications include:
TSCA and Engineered Nanoscale Substances, Nanotechnology
Law and Business (2007) (co-author); The Nanotechnology-Biology
Interface: Exploring Models for Oversight, Center for
Science, Technology & Public Policy, University of
Minnesota (2006) (co-author); “Pesticides, Chemical
Regulation, and Right-to-Know: 2005 Annual Report -- The
Risks and Benefits of Nanoscale Materials," in Environment,
Energy, and Resources Law: The Year in Review 2005, ABA
(2005); Selected Challenges in Applying Toxicogenomic
Data in Federal Regulatory Settings, Proceedings of Workshop
on Genetics and Environmental Regulation (2005) (co-author); “Pesticides,
Chemical Regulation, and Right-to-Know: 2004 Annual Report" in
Environment, Energy, and Resources Law: The Year in Review
2004, ABA (2004); The RCRA Practice Manual, ABA (2004);
The TSCA Basic Practice Book, ABA (2000); The FIFRA Basic
Practice Book, ABA (2000); Pesticides Law Handbook, Government
Institutes (1999); Avoiding Liability for Hazardous Waste:
RCRA, CERCLA and Related Corporate Law Issues, Bureau
of National Affairs, Corporate Practice Series (1999);
Chapter 7 -- Liability, Environmental Law Practice Guide,
Matthew Bender (1992); and The Expanding Scope of Liability
for Environmental Damage and Its Impact on Business Transactions,
The Corporation Law Review (Spring 1985).
April 17, 2007 Wall Street Reporter Interviews Lynn
L. Bergeson
The Acta Group, L.L.C. is pleased to announce that
Wall Street Reporter interviewed Lynn
L. Bergeson on April 16, 2007, regarding regulatory
developments concerning nanoscale materials.
April 11, 2007 BERGESON & CAMPBELL, P.C. ANNOUNCES
LYNN L. BERGESON WILL SPEAK AT NANOBUSINESS 2007 Bergeson Will Speak About Regulatory
Developments and Emerging Issues in Nanotechnology
Bergeson & Campbell, P.C. (B&C) is pleased to
announce that Lynn L. Bergeson will
speak about regulatory developments and emerging environmental
health and safety issues in nanotechnology at the Sixth
Annual NanoBusiness Alliance Conference in New York City.
Ms. Bergeson will speak on Sunday, April 15, 2007.
B&C, which is a proud co-sponsor of the Conference,
has made a concerted effort to be in the forefront of
the science policy debate involving nanotechnologies and
other emerging technologies. Ms. Bergeson and other professionals
at B&C counsel clients on health, safety, science
policy, and related legal and regulatory aspects of nanotechnology
and emerging transformative technologies, and on more
traditional chemical product approval matters. Ms. Bergeson
serves on the President’s Council of Advisors on
Science and Technology (PCAST) Nanotechnology Technical
Advisory Group (PCAST nTAG). She also serves on the U.S.
Environmental Protection Agency’s (EPA) Steering
Committee for the Pollution Prevention Through Nanotechnology
Conference. Ms. Bergeson served in 2004 and 2005 on the
American National Standards Institute (ANSI) Nanotechnology
Standards Panel (NSP) Steering Committee and is now a
member of the ISO Technical Committee 229 on Nanotechnologies.
Ms. Bergeson serves on the Executive Committee of the
Environmental Law Institute’s (ELI) Board of Directors,
and is Immediate Past Chair of the American Bar Association
(ABA) Section of Environment, Energy, and Resources, serves
in other ABA leadership positions, and leads the Section’s
efforts to identify the legal authority available to the
federal government to regulate nanotechnology under existing
federal statutes and other legal authority. See http://www.abanet.org/environ.
Ms. Bergeson is a member of the Converging Technologies
Bar Association (CTBA), Board of Directors and Chair of
the CTBA Environmental, Health, and Safety Committee.
Recent publications include: TSCA and Engineered Nanoscale
Substances, Nanotechnology Law and Business (2007) (co-author);
The Nanotechnology-Biology Interface: Exploring Models
for Oversight, Center for Science, Technology & Public
Policy, University of Minnesota (2006) (co-author); “Pesticides,
Chemical Regulation, and Right-to-Know: 2005 Annual Report
-- The Risks and Benefits of Nanoscale Materials," in
Environment, Energy, and Resources Law: The Year in Review
2005, ABA (2005); Selected Challenges in Applying Toxicogenomic
Data in Federal Regulatory Settings, Proceedings of Workshop
on Genetics and Environmental Regulation (2005) (co-author); “Pesticides,
Chemical Regulation, and Right-to-Know: 2004 Annual Report" in
Environment, Energy, and Resources Law: The Year in Review
2004, ABA (2004); The RCRA Practice Manual, ABA (2004);
The TSCA Basic Practice Book, ABA (2000); The FIFRA Basic
Practice Book, ABA (2000); Pesticides Law Handbook, Government
Institutes (1999); Avoiding Liability for Hazardous Waste:
RCRA, CERCLA and Related Corporate Law Issues, Bureau
of National Affairs, Corporate Practice Series (1999);
Chapter 7 -- Liability, Environmental Law Practice Guide,
Matthew Bender (1992); and The Expanding Scope of Liability
for Environmental Damage and Its Impact on Business Transactions,
The Corporation Law Review (Spring 1985).
March 6, 2007 FORMER EPA OFFICE OF GENERAL COUNSEL
LAWYER TIMOTHY D. BACKSTROM JOINS
BERGESON & CAMPBELL, P.C. Former EPA Attorney
Brings Extensive Experience in Pesticide and Air Quality
Issues
Timothy D. Backstrom, former attorney for the U.S. Environmental
Protection Agency (EPA)’s Office of General Counsel,
has joined Bergeson & Campbell, P.C.
Tim Backstrom has a distinguished career in government
service. While in EPA’s Pesticides and Toxic Substances
Division of the Office of General Counsel, he was responsible
for negotiations with paint and coating manufacturers,
which led to the elimination of mercury compounds used
in paints and coatings. Tim also supervised extensive
litigation involving the chemical dinoseb, including nine
federal court actions and four formal administrative adjudications.
While in EPA’s Air and Radiation Division, Tim
managed complex litigation involving hazardous air pollutants
(HAP) and fuel additives. He also worked on a variety
of rulemakings implementing the 1990 Clean Air Act Amendments,
including issuance of various emission standards for HAPs,
delisting of particular HAPs and source categories, and
review of the National Ambient Air Quality Standards for
nitrogen oxides and carbon monoxide. Tim was also EPA’s
lead counsel in the lawsuit that led to settlement of
the omnibus litigation concerning the general provisions
for HAP emission standards and individual emission limitations
adopted by permit.
Tim holds an undergraduate degree in environmental science
from the Massachusetts Institute of Technology and a J.D.
with honors from Yale Law School.
February 1, 2007 EPA Regulates Nano Product, Not Nano
Industry
The January/February 2007 issue of Small
Times quotes Lynn L. Bergeson regarding
the U.S. Environmental Protection Agency's decision to review
the Samsung silver ion generating washing machine as a device
under the Federal Insecticide, Fungicide, and Rodenticide
Act.
January 17, 2007 2007 Outlook: REACH, New Regulations
in U.S. States Suggest Volatile Year for Manufacturers
The January 17, 2007, issue of BNA's Daily
Environment Report quotes Lynn
L. Bergeson and Jim Aidala regarding
global chemical regulation issues in 2007. Bergeson commented
on the Congressional oversight hearings expected to be held
on the Toxic Substances Control Act, stating: "Given
the election results, which at the moment leave both houses
of Congress in Democratic control, EPA is bracing itself
for almost certain congressional 'investigations,' inquiries,
oversight hearings and requests, and related interventions." Aidala
commented on the challenge of passing legislation that would
allow the United States to ratify the Stockholm Convention
on Persistent Organic Pollutants (POP), the POPs Protocol
to the Convention on Long Range Transboundary Air Pollution,
and the Rotterdam Convention on the Prior Informed Consent
Procedure for Certain Hazardous Chemicals and Pesticides
in International Trade.
December 4, 2006 Life Plus LLC forms strategic alliance with Washington,
D.C.-based consulting firm
WEST LAFAYETTE, Ind. and WASHINGTON, D.C., December
4, 2006 — West Lafayette-based Life Plus
LLC announced today it has entered into an exclusive collaborative
partnership with Washington, D.C.-based
The Acta Group LLC to provide expertise on Asia's biotechnology-related
product registration process.
The Acta Group is a consulting affiliate of Bergeson & Campbell,
P.C., a leading Washington, D.C., law firm
that assists with product approval and regulation, product
defense and associated business issues for a large
number of clients in several countries with chemical control
laws.
As a Purdue Research Park-based company that specializes
in regulatory approval support services (i.e.
compiling supporting toxicology data packages, including
expert statements, literature reviews and risk
assessments), Life Plus will collaborate with The Acta
Group to control the spiraling costs and inefficiencies
experienced by clients seeking regulatory approval to
commercialize new chemical technologies, as well as
products of biotechnology, nanotechnology and medical
devices.
"Life Plus' affiliation with several Chinese toxicology
labs provides an advantage to clients by improving the
speed of mandatory testing in Chinese labs and by reducing
the testing costs, which can exceed several
hundred thousand dollars," said Mark Cisneros, Ph.D.,
president and CEO of Life Plus, which has been
successful in its efforts to gain regulatory approvals
for chemical and medical device technologies attempting
to enter the Chinese marketplace.
"Bergeson & Campbell's and its affiliate's chemical
regulatory practice is best-in-class and broadly focused,
and this collaboration with Acta will allow Life Plus
to offer services in new regulatory areas — such
as
agrochemicals and nanotechnologies — to our expanding
client base," Cisneros said.
"We take a multidisciplinary approach in assisting
our clients, partnering with toxicological, chemical,
engineering, economic, and other experts on individual
matters as necessary to achieve results effectively
and efficiently," said Lynn L. Bergeson, president
of The Acta Group and a founding member of Bergeson &
Campbell, P.C. "We chose Life Plus because the company
has an outstanding reputation in delivering a fullservice
offering to clients interested in commercializing new
chemical technologies in the Asian marketplace."
About Life Plus, LLC
With headquarters at Purdue Research Park in West Lafayette,
Ind., and operations in Beijing, China, Life
Plus LLC offers regulatory
guidance and trade development support to firms
throughout the world. The company's customer-focused
philosophy has generated valuable results for clients,
including the first successful navigation of a new substance
notification through the Chinese's new chemical
control law. Purdue Research Park is one of the largest
business/science parks in the country and home to
companies developing technologies discovered at the
Birck Nanotechnology Center, the cornerstone for
Purdue University's $300 million Discovery Park. Within
Purdue Research Park, 140 businesses, of which
more than 90 are high-tech, employ more than 2,900 people.
October 24, 2006
THE ACTA GROUP, L.L.C., ANNOUNCES THE LAUNCH
OF ITS UK OFFICE, THE ACTA GROUP EU, LTDUK Center to “Fast-Track" Regulatory
Response
The Acta Group, L.L.C. (Acta) is pleased to announce
the launch of its UK-based consulting affiliate, The Acta
Group EU, Ltd (Acta EU). Acta EU focuses on chemical product
approval, support, and regulatory defense to help industry
tackle the intimidating landscape of increasing chemical
regulation in the region.
Acta EU has opened an office near Manchester, UK, with
a team of specialists in product registration, regulatory
issues, and toxicology as a center of expertise for industry.
The company’s experience covers the industrial chemical,
agrochemical, biocide, biotechnology, and nanotechnology
sectors and also medical devices.
“Regardless of a product’s efficacy and economics,
our industry’s biggest challenge in developing new
markets and supporting existing portfolios are regulatory
issues. One mistake can sink a project in a moment," comments
Lynn Bergeson, the head of Acta in Washington, D.C. and
an attorney who has more than 20 years of experience in
this sector.
The company already works with many U.S.-based chemical
manufacturers and product formulators, and expansion into
the European market has been prompted in part by the increasing
challenges international businesses encounter in the European
Union (EU) markets -- most recently the EU’s REACH
regulatory framework (Registration, Evaluation, and Authorization
of Chemicals).
“The spiralling costs and inefficiencies of regulatory
systems make Europe an intimidating landscape in which
to operate. Our role is to navigate through this minefield
and get products to market more quickly and defend existing
positions for our customers," she added.
The Acta EU regulatory team provides project management
to fast-track product approval and registration, and to
build support and defense packages for product portfolios.
Toxicology specialists compile supporting data packages,
including literature searches, reviews, and risk assessments.
In addition to assisting industry with REACH, Acta EU
focuses on supporting the registration and approval of
industrial chemical and agrochemical products and defending
existing product approvals in the EU review process. Nanotechnology
is an important, emerging field where Acta EU will work
to support and protect the industry’s operational
flexibility, as authorities begin to develop regulatory
frameworks for the sector.
Acta EU is based at The Heath Technology Park in Runcorn,
near Manchester, in the heart of the UK chemical industry.
Key personnel are listed below:
Dr. Alison Bartlett, Regulatory Manager -- Dr. Bartlett
has worked both as a freelance consultant in document
preparation and for the UK Health & Safety Executive
as a Regulatory Toxicologist, preparing and appraising
industrial chemical hazard and risk assessment documents
produced under the ESR, OECD, NONS, and related industrial
and agricultural chemical programs. Dr. Bartlett received
her BSc. (Hons) in Biomedical Technology from Sheffield
City Polytechnic and received her Ph.D. from Liverpool
John Moores University in QSAR of the Immunotoxicity of
beta-lactam antibiotics, sponsored by Glaxo SmithKline.
August 28, 2006 HENRY M. JACOBY, MS JOINS
BERGESON & CAMPBELL, P.C. LAW FIRM AND THE ACTA GROUP, L.L.C. AND THE ACTA GROUP, EU, LTD. CONSULTING PRACTICES
Mr. Jacoby Brings Extensive Experience in
Pesticide Product Registration and Arbitration Issues
Henry M. Jacoby, MS, former Branch Chief of the U.S. Environmental Protection Agency’s (EPA) Environmental Fate and Ground Water Branch, has joined Bergeson & Campbell, P.C. and its consulting affiliates, The Acta Group, L.L.C. (Acta) and The Acta Group, EU, Ltd. (Acta EU).
Mr. Jacoby has over 34 years of experience in assisting pesticide, insecticide, herbicide, fungicide, antimicrobial, wood preservation, and antifouling paint manufacturers and formulators in the area of environmental science and applications for federal and state pesticide registrations and tolerance petitions. Twenty-five years of his experience were gained at EPA, where he worked in the Office of Pesticide Programs as a Chemist, Product Manager, Senior Staff Member, and Branch Chief. Upon retiring from EPA, Mr. Jacoby joined the consultant firm of Charles, Conn & van Gemert, LLC as Director of Environmental Affairs. In 2001, Mr. Jacoby established his own regulatory consultant business. Mr. Jacoby holds an undergraduate degree in Chemistry from St. Norbert College and an M.S. in Management from Frostburg State University.
Because of his broad registration experience, Mr. Jacoby has been invited to give numerous seminars at major universities in the United States and at scientific and industrial conferences. He has organized national and international symposia for the scientific communities on environmental risk assessments used in registration of pesticides.
July 17, 2006 Lynn L. Bergeson Included in The Chambers USA Guide
We are pleased to announce that Lynn L. Bergeson has been included in The Chambers USA Guide for 2006. The USA Guide is based on over 10,000 in-depth interviews with clients and attorneys. Chambers & Partners then ranked the top firms and attorneys and described their merits -- often in the words of clients they interviewed. Rankings include technical legal ability, professional conduct, client service, commercial awareness/astuteness, diligence, commitment, and other qualities most valued by the client. The rankings and editorial comment about attorneys are independent and objective, and financial considerations play no part in the research process. Bergeson is “prominent in the chemicals and pesticide spheres." In interviews, Bergeson was described as “a delightful person, honest and upfront. When providing legal advice, she is right on the money."
June 26, 2006
JOSEPH E. PLAMONDON, PH.D. JOINS BERGESON & CAMPBELL,
P.C. LAW FIRM AND THE ACTA GROUP, L.L.C. AND THE ACTA
GROUP, EU, LTD. CONSULTING PRACTICES
Dr. Plamondon Brings Extensive Experience in Industrial Chemical Issues
Joseph E. Plamondon, Ph.D., former Director of Regulatory
Affairs for Consortium for Environmental Risk Management,
LLC (CERM), has joined Bergeson & Campbell, P.C. and
its consulting affiliates, The Acta Group, L.L.C. (Acta)
and The Acta Group, EU, Ltd. (Acta EU).
Dr. Plamondon has a long and distinguished career, and is well known in the industrial chemical community. As Director of Regulatory Affairs for CERM, Dr. Plamondon was responsible for research and development and new product development activities. He also provided strategic preparation and submission of premanufacture notifications (PMN) designed to avoid Toxic Substances Control Act (TSCA) Section 5(e) consent orders and other adverse regulations. Prior to joining CERM, Dr. Plamondon was a staff scientist at Keller and Heckman LLP. Dr. Plamondon also brings a wealth of experience from his prior positions with Akzonobel Chemicals, Inc, Technology Sciences Group Inc., and Rohm and Haas Company. Dr. Plamondon holds an undergraduate degree in chemistry from Loras College, an M.S. in bio-organic chemistry from the University of California at Berkeley, and a Ph.D. from the University of California at Davis.
Dr. Plamondon has presented at many conferences and professional meetings, e.g., the American Chemistry Council’s Global Chemical Regulations Conference (Living with TSCA), among others, and has written extensively on chemical regulatory matters. His most recent article, “The DuPont TSCA Enforcement Action: Implications for the Chemical Industry," was published in Environmental Quality Management.
June 19, 2006 Lynn L. Bergeson Included in The International Who’s Who of Business Lawyers We are pleased to announce that Lynn L. Bergeson has been included in The International Who’s Who of Business Lawyers for 2006. Bergeson, who is listed in the Who’s Who for the second time and is included in the breakdown of environmental “stars" for the first time, is described as “a real go-getter in the chemical regulatory field." The publication is based on research, including conversations with private practice lawyers of repute in the practice area in question or in related fields, as well as with general counsel. The individuals and firms they recommend are then canvassed using questionnaires. Who’s Who Legal then collates the returned data with information obtained from legal and financial media and respondent corporate counsel. A preliminary listing is distributed to all lawyers who were mentioned during the research. Telephone and face-to-face interviews are conducted internationally to refine the listing to a selection of between 200 and 600 lawyers who, by general agreement, are considered the pre-eminent lawyers in the field.
Who’s Who Legal sets a high nomination threshold for inclusion in The International Who’s Who of Business Lawyers. Only those lawyers who have met the independent research criteria are recommended and listed. Financial considerations play no part in the research process.
June 19, 2006 Regulating Nanotech Debated: Ensuring Safety Without Stifling Key Innovation
The June 12, 2006, issue of the San Francisco Chronicle quotes Lynn L. Bergeson regarding the need for nanotechnology regulations, in addition to those under the Toxic Substances Control Act. Bergeson states: "EPA is taking a harder look at whether these (regulations) are sufficient, as many believe, or need some tweaks."
May 16, 2006 Firms Making Nanoengineered Pesticides Urged to Meet With EPA Staff on Data Needs
The May 15, 2006, issue of BNA's Daily Environment Report quotes Lynn L. Bergeson regarding how the U.S. Environmental Protection Agency could use the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to regulate nanoengineered pesticides.
May 16, 2006 The Nanotechnology-Biology Interface: Exploring Models for Oversight
The workshop report for the University of Minnesota's Center for Science, Technology & Public Policy's September 15, 2005, workshop entitled "The Nanotechnology-Biology Interface: Exploring Models for Oversight" includes a summary of Lynn L. Bergeson's presentation regarding safety concerns and governance systems. The report is available on the university's website.
April 20, 2006 The Chemistry Is Right for Democrats
The March/April 2006 issue of The Environmental Forum quotes Lynn L. Bergeson regarding the adverse effects to the chemical industry of inferences drawn from biomonitoring data.
February 22, 2006 Lynn L. Bergeson Included in The International Who’s Who of Environment Lawyers We are pleased to announce that Lynn L. Bergeson has been included in The International Who’s Who of Environment Lawyers, an extract from the 2006 edition of The International Who’s Who of Business Lawyers. Bergeson is described as “a real go-getter in the chemical regulatory field." The publication is based on research, including conversations with private practice lawyers of repute in the practice area in question or in related fields, as well as with general counsel. The individuals and firms they recommend are then canvassed using questionnaires. Who’s Who Legal then collates the returned data with information obtained from legal and financial media and respondent corporate counsel. A preliminary listing is distributed to all lawyers who were mentioned during the research. Telephone and face-to-face interviews are conducted internationally to refine the listing to a selection of between 200 and 500 lawyers who, by general agreement, are considered the pre-eminent lawyers in the field.
Who’s Who Legal sets a high nomination threshold for inclusion on The International Who’s Who of Environment Lawyers. Only those lawyers who have met the independent research criteria are recommended and listed. Financial considerations play no part in the research process.
January 20, 2006
Industry Expects Pivotal Year for Regulation of Chemicals by EU, International Body
In the January 20, 2006, issue of BNA's Daily Environment Report, Lynn L. BergesonandJim V. Aidala are quoted regarding the impact the Registration, Evaluation, and Authorization of Chemicals (REACH) legislation would have U.S. chemical producers and exporters, California's biomonitoring legislation, Congressional priorities, and the U.S. Environmental Protection Agency's (EPA) activities regarding perfluorooctanoic acid (PFOA).
October 13, 2005 Regulatory Initiatives 'Essential' To 'Facilitate Comfort' With Nanotechnology
In the October 13, 2005, issue of the BNA's Occupational Safety and Health Reporter, Lynn L. Bergeson is quoted regarding the business impacts and considerations surrounding nanotechnology. Bergeson states that the final goal of business certainty "will continue to be elusive and requires public confidence in nanotechnology, other emerging technologies, and products of nanotechnology."
October 11, 2005 Traditional Industries Generate Nanoparticles; Particle Tests May Change Health Priorities
In the October 10, 2005, issue of the BNA's Chemical Regulation Reporter, Lynn L. Bergeson describes the proliferation of federal regulations and nontraditional governmental risk management initiatives to address nanotechnologies expected in coming months and years.
October 3, 2005
The Business of Law Lynn L. Bergeson is quoted in the October 2005 issue of Washington Lawyer in an article entitled "The Business of Law." Bergeson describes the benefits of allowing employees to telecommute.
August 12, 2005 LYNN L. BERGESON ELECTED TO SERVE AS CHAIR OF THE AMERICAN BAR ASSOCIATION SECTION OF ENVIRONMENT, ENERGY, AND RESOURCES
We are delighted to announce that Lynn L. Bergeson has been elected to serve as Chair of the American Bar Association Section of Environment, Energy, and Resources for 2005-2006. The Section of Environment, Energy, and Resources is the premier forum for lawyers working in areas related to the environment, natural resources, and energy. It represents more than 10,000 members with a wide range of professional interests. Lynn has long been active in the Section and has served in a number of leadership roles for the Section.
Lynn L. Bergeson is Managing Director of Bergeson & Campbell, P.C., a law firm concentrating on chemical product approval, regulation, product litigation, and associated business issues. In addition to her service to the American Bar Association, Ms. Bergeson serves on the Board and Executive Committee of the Environmental Law Institute, and serves on the editorial boards of a number of chemical regulatory and environmental publications.
About the American Bar Association
The American Bar Association’s Section of Environment, Energy, and Resources provides members with opportunities to enhance professional skills, stay on top of developments, and participate in dialogue in these substantive areas. The Section keeps members abreast on developing trends, current court decisions, legislative initiatives, and statutes concerning environmental, natural resources, and energy law.
With more than 400,000 members, the American Bar Association is the largest voluntary professional membership organization in the world. As the national voice of the legal profession, the American Bar Association works to improve the administration of justice, promotes programs that assist lawyers and judges in their work, accredits law schools, provides continuing legal education, and works to build public understanding around the world of the importance of the rule of law in a democratic society.
July 6, 2004
Lynn L. Bergeson Included in The Chambers USA Guide We are pleased to announce that Lynn L. Bergeson has been included in The Chambers USA Guide: America’s Leading Lawyers for Business (USA Guide) for 2005. The USA Guide is based on over 10,000 in-depth interviews with clients and attorneys. Chambers & Partners then ranked the top firms and attorneys and described their merits -- often in the words of clients they interviewed. Rankings include technical legal ability, professional conduct, client service, commercial awareness/astuteness, diligence, commitment, and other qualities most valued by the client. The rankings and editorial comment about attorneys are independent and objective, and financial considerations play no part in the research process. In interviews, Bergeson was described as “excellent, pragmatic and effective."
June 16, 2005 Regulation of Nanoparticles Urged by Nanotechnology Research Firm
In the June 16, 2005, issue of BNA's Daily Environment Report, Lynn L. Bergeson comments on the Lux Research report entitled A Prudent Approach to Nanotech Environmental Health and Safety Risks. According to Bergeson, the report "appears useful and relatively reflective of the views of many in the industry."
April 26, 2005 Researcher Says Makers of Nanomaterials Face Patent Challenges, Possible Regulation
The April 26, 2005, issue of BNA's Daily Environment Report quotes Lynn L. Bergeson regarding a voluntary pilot program that the U.S. Environmental Protection Agency (EPA) is considering establishing for nanomaterials. According to Bergeson, EPA will seek comment on various approaches it could take to manage nanomaterials to ensure "regulatory hurdles will be required only if necessary." Bergeson noted that other issues that will define the risks and benefits of nanomaterials include public acceptance, investor acceptance, export controls, patent protection, patent infringement avoidance, and risk communication/insurance.
April 18, 2005 Regulating Chemicals: Concerns regarding REACH, nanomaterials, biomonitoring voiced at GlobalChem meeting
The April 4, 2005, issue of Chemical & Engineering News quotes Lynn L. Bergeson regarding the possibility that the U.S. Environmental Protection Agency may attempt to use its authority under the Clean Water Act, Clean Air Act, and other statutes to control management and disposal of nanomaterials
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