Lynn L. Bergeson, "Chemical Management, North American Style," Environmental Quality Management, Spring 2008. This “Washington Watch” column discusses the Montebello Agreement, noting its origin in the Security and Prosperity Partnership of North America and explaining its potential implications for the future. The discussion also provides context on other chemical management schemes -- particularly REACH.
Lynn L. Bergeson, "2008 Outlook for Chemicals and Pesticides," Pollution Engineering, March 2008. With this being an election year, little legislation is expected to be considered during 2008 on the environmental front. Endocrine disruptors, however, will be a main subject of review in 2008. The U.S. Environmental Protection Agency (EPA) seeks to impose the initial screening test requirements on a number of pesticides before the end of this year. Any test results will then be considered by the next administration, but even before that, the selection or removal from the list of pesticides to be tested may itself become controversial.
Lynn L. Bergeson, "Act Before There’s Not a Drop to Drink," Chemical Processing, February 2008. Ground water protection is the responsibility of everyone including the chemical industry. An energetic group of state and federal ground water agencies, industry, environmentalists and other stakeholders, however, has made it a key area of their focus. The Ground Water Protection Council (GWPC) is a nonprofit Section 501(c)(6) organization dedicated to promoting and ensuring the use of best management practices and “fair but effective” laws regarding comprehensive groundwater protection.
Lynn L. Bergeson, "The Semiannual Regulatory Agenda: A Useful Document," Pollution Engineering, February 2008. EPA’s Semiannual Regulatory Agenda is an excellent source of information on environmental regulatory and policy developments. As its names suggests, this document is issued twice a year, once in the spring and again around mid-December. It is chock full of information on EPA regulations and major policy initiatives that are under development, reviews of existing regulations, and major policy makings completed and/or cancelled since the previous agenda. For any environmental professional, the Regulatory Agenda, as it has come to be called, is indispensable.
Lynn L. Bergeson, "Get the Lead Out," Chemical Processing, January 2008. By any independent standard, the federal government has made significant progress in reducing lead concentrations in ambient air. Average lead concentrations have dropped 96% since the 1980s, primarily due to the ban on lead in motor vehicle gasoline. Since the late 1970s, bloodlead concentrations for children ages 1 to 5 have decreased dramatically, from about 15 micrograms per deciliter to less than 2. The success has been so dramatic, the U.S. Environmental Protection Agency (EPA) is now considering whether to maintain, revise, or eliminate current lead National Ambient Air Quality Standards (NAAQS). EPA, in late December, issued an advance notice of proposed rulemaking (ANPR) and invited comment on all issues. This is the chemical industry’s opportunity to provide input.
Lynn L. Bergeson, "REACHing the Montebello Agreement," Pollution Engineering, January 2008. In August, EPA, Canada and Mexico announced in Montebello, Quebec, new efforts to ensure the safe manufacture and use of industrial chemicals by entering into a regional partnership for assessing and managing potential chemical risks. As part of what is now referred to as the "Montebello Agreement" made at the Security and Prosperity Partnership (SPP) of North America Leaders' Summit, these countries agreed to coordinate efforts to assess approximately 9,000 industrial chemicals that are produced or imported in volumes above 25,000 pounds per year.
Lynn L. Bergeson, "Product Stewardship Grows Globally," Chemical Processing, December 2007. Product stewardship can be expressed in many ways, and there’s no single best definition. According to the U. S. Environmental Protection Agency (EPA), “[p]roduct stewardship is a product-centered approach to environmental protection. Also known as extended product responsibility (EPR), product stewardship calls on those in the product life cycle -- manufacturers, retailers, users and disposers -- to share responsibility for reducing the environmental impacts of products (www.epa.gov/epaoswer/non-hw/reduce/epr/about/index.htm).”
Lynn L. Bergeson, "Good Governance: Evolution of the Nanoscale Materials Stewardship Program," Nanotechnology Law & Business, Winter 2007. Governance issues are seldom the subject of wide consensus, and the question of how best the U.S. Environmental Protection Agency (EPA) should obtain needed information and data on the human health and environmental implications of nanoscale materials is no exception. EPA has considered the issue carefully and believes, with good reason, that a voluntary approach makes the most sense at this time. Not everyone agrees, however, and some urge EPA to exercise its statutory authority under the Toxic Substances Control Act (TSCA) to mandate the submission of information and data, and to do so quickly. This article discusses the origins and current status of EPA’s voluntary Nanoscale Materials Stewardship Program (NMSP), outlines the key issues EPA confronted in developing the Program, and discusses the reasons why it is critically important for nanotechnology stakeholders to participate in the Program early and robustly. While stakeholders may not agree on what is the best way for EPA to obtain information on nanoscale materials, there is broad consensus that NMSP participation is critically important to maintain the public trust and confidence in this emerging technology, to provide EPA with needed information and data, and to demonstrate that potentially more burdensome rulemaking initiatives are not needed to achieve these goals.
Lynn L. Bergeson and I. Dassa, "TSCA and Engineered Nanoscale Substances," Sustainable Development Law and Policy, Fall 2007. Nanotechnology is now the subject of much excitement and attention, with applications proliferating quickly. Thus, engineered nanoscale materials’ (“ENM”) implications for human health and the environment, and the critical need for governments throughout the world to get the policy and regulatory framework right has garnered much attention. Most would agree that the ultimate goal for society is to enable nanotechnology to realize its potential while effectively addressing the pertinent environment, health, and safety (“EHS”) issues associated with ENM.
Lynn L. Bergeson, Ira Dassa, and Steven Green, "REACH
and Pesticides: What U.S. Exporters May Not Realize," Daily
Environment Report, Nov. 7, 2007. Pesticide manufacturers and formulators
may believe (blissfully so) that the European Union’s Registration, Evaluation,
Authorization and Restriction of Chemicals (REACH) regulation
is someone else’s headache. After all, it applies
to industrial chemicals, not pesticides. Think again.
Inert ingredients included in pesticide formulations are
subject to REACH, as are nonpesticidal uses of active
ingredients. This article discusses these aspects of REACH
and outlines what pesticide formulators and others need
to know about the new regulation.
Lynn L. Bergeson, "The
EPA’s Toxic
Substances Control Act: What you must know," Environmental
Expert Newsletter, November 2007. Does the nanoscale substance
you are producing or using require approval under the
U.S. Environmental Protection Agency’s (EPA) Toxic Substances Control Act (TSCA)?
It does if it’s new. But what exactly is “new?”
Lynn L. Bergeson, "Chemical
Facility Anti-Terrorism Standards: Chemicals of Interest," Environmental
Quality Management, Autumn 2007. In the last issue of Environmental
Quality Management, this column discussed the April 2,
2007, U.S. Department of Homeland Security (DHS) interim
final rule on anti-terrorism standards for chemical facilities.
On the same day the interim final rule was issued, DHS
also issued (and requested comment on) a list of 344 “chemicals
of interest,” included
in Appendix A to the rule. This "Washington Watch" briefly
reviews key issues associated with the chemicals of interest,
as well as the comments received on the proposed chemical
list, and the Department's likely next steps in this regard.
Lynn L. Bergeson, "The
EPA’s Toxic Substances
Control Act: What You Must Know," Small
Times Magazine,
September/October 2007. Does the nanoscale substance
you are producing or using require approval under the
U.S. Environmental Protection Agency’s (EPA) Toxic
Substances Control Act (TSCA)? It does if it’s new.
But what exactly is “new?”
Lynn L. Bergeson, "EPA
Identifies Endocrine Disruptor Chemicals," Pollution
Engineering, September 2007. On June 18, 2007, EPA issued
its long-awaited draft list of chemicals selected for
so-called “Tier 1” screening
under the Endocrine Disruptor Screening Program (EDSP).
EPA repeatedly emphasized in the notice, as well as in
other statements it prepared relating to the notice, that
the list should not be construed as a list of known or
likely endocrine disruptors. The final list of chemicals
will be issued after the comment period closes and the
agency reconsiders the list of 73 chemicals.
Lynn L. Bergeson, "TSCA
Inventory Status of Nanoscale Substances a Must-Read for
Materials Developers," Small
Times Magazine, August 10, 2007. The EPA's recently released paper,
TSCA Inventory Status of Nanoscale Substances -- General
Approach, is important for developers of nanotechnologies.
Nanomaterials that meet the Toxic Substances Control Act
(TSCA) definition of "chemical substance" are subject to TSCA
reporting requirements because they may exhibit properties
different from the same substances in the bulk scale.
A chemical substance means, in relevant part, "any
organic or inorganic substance of a particular molecular
identity."
Lynn L. Bergeson, "EPA
Issues Draft NMSP Concept Paper and TSCA Inventory Paper," ABA
Pesticides, Chemical Regulation, and Right-to-Know Committee
Newsletter, Vol. 8, No. 3, August 2007. On July 12, 2007,
the U.S. Environmental Protection Agency (EPA) published
in the Federal Register three separate notices related
to the long-awaited Nanoscale Materials Stewardship Program
(NMSP) under the Toxic Substances Control Act (TSCA).
All of the notices and accompanying documents are available
at http://www.epa.gov/opptintr/nano/nmspfr.htm.
Lynn L.
Bergeson, "Nanotechnology,
Boom or Bust," Pollution
Engineering, August 2007. A well-known consumer organization
now believes that the government should provide more
funds for risk research and regulation of nanotechnology,
and should require manufacturers to report health problems
linked with nano-ingredients.
Lynn L. Bergeson, "Redefining
Solid Waste -- Again," Pollution
Engineering,
July 2007. On March 26, 2007, EPA announced
the issuance of a sweeping proposal to modify the RCRA
definition of solid waste. The proposal seeks to streamline
regulation of hazardous secondary materials, and revise
the definition of solid waste to exclude certain secondary
materials from RCRA regulation to promote the legitimate
recycling of these materials. The proposed rule is available
at http://www.epa.gov/fedrgstr/EPA-WASTE/2007/March/Day-26/f5159.pdf,
and comments were due on or before May 25, 2007.
Lynn L. Bergeson, "State
and Local Governments Step Into Toxics Regulation," ABA
Pesticides, Chemical Regulation, and Right-to-Know Committee
Newsletter, Vol. 8, No. 2, June 2007. According to the Center for International
Environmental Law (CIEL), federal inaction on chemicals
management and regulation has spurred state and even local
government entities to step into toxics regulation. CIEL
issued a position paper last May, Cloudy Skies, Chance
of Sun: A Forecast for U.S. Reform of Chemicals Policy,
predicting exactly this result. CIEL points to the fact
that at least six states that have enacted legislation
or issued some other state initiative to restrict certain
polybrominated flame retardants. As discussed below, several
recent initiatives tend to support the view that state
and local governments are more willing now than previously
to consider legislation on and issue regulations pertinent
to chemical substances.
Lynn L. Bergeson, "Chemical
Facility Anti-Terrorism Standards: The Final Rule
is Out, but the Debate Continues," Environmental
Quality Management, Summer 2007. On April 2, 2007, the U.S. Department
of Homeland Security (DHS) issued its much-awaited interim
final rule on anti-terrorism standards for chemical facilities.
The rule was published a week later in the Federal Register.
The interim final rule is quite similar to the proposed
rule that DHS published under an Advance Notice of Proposed
Rulemaking in December 2006. The interim final rule does
manage to address several of the more controversial issues
generated by the December proposal. As is usually the case,
however, not everyone is happy with the outcome. This column
briefly reviews the legislative mandate authorizing the
rule, summarizes the interim final regulation, and outlines
the key issues that continue to inspire debate on the hot
topic of chemical plant security.
Lynn L. Bergeson, "'Innocent
Report Shows How Regs Vary Around the World," Manufacturing
Today, May/June 2007.
Lynn L. Bergeson, "EPA
Speeds Alternative Method Approvals," Pollution
Engineering,
June 2007. As anyone in the water business will tell you, standard
analytical methods are critically important. On April
10, 2007, the EPA announced its intent to implement an
expedited process for approving alternative analytical
testing methods under various federal water programs.
Lynn L. Bergeson, "EPA
Issues Proposed Revisions to Definition of Solid Waste," Environmental
Expert Newsletter, June 2007. The definition of “solid waste” under the
federal Resource Conservation and Recovery Act (RCRA)
is unquestionably one of the most difficult environmental
concepts to get one's head around. Even after 27 years,
the U.S. Environmental Protection Agency (EPA) is still
tinkering with revisions to the definition to better define
the types of recycling activities that fall within the
scope of the definition, and those that fall outside of
its scope. In March, EPA announced issuance of a sweeping
and long-awaited proposal to modify the RCRA definition
of solid waste. The proposal seeks to streamline regulation
of so-called hazardous “secondary” materials,
and revise the all-important definition of solid waste
to exclude certain secondary materials, such as solvents,
metals and certain other chemicals, from RCRA regulation
to promote the legitimate recycling of such materials.
Lynn L. Bergeson, "EPA
Issues Metals Risk Assessment Framework," Pollution
Engineering, May 2007. Businesses have long believed
that assessing potential risks from metal and inorganic
chemical exposures are qualitatively and quantitatively
different from assessing potential risks from organic
chemical substances. On March 8, EPA capped off an intensive
effort that fundamentally recognized these differences
in announcing the availability of its final Framework
for Metals Risk Assessment. The framework is available
at http://www.epa.gov/osa/metalsframework/pdfs/metals-risk-assessment-final-3-8-07.pdf.
Lynn L. Bergeson, "EPA
Issues Proposed Revisions to Definition of Solid Waste," Manufacturing
Today, March/April 2007. The definition of “solid waste” under the
federal Resource Conservation and Recovery Act (RCRA)
is unquestionably one of the most difficult environmental
concepts to get one's head around. Even after 27 years,
the U.S. Environmental Protection Agency (EPA) is still
tinkering with revisions to the definition to better define
the types of recycling activities that fall within the
scope of the definition, and those that fall outside of
its scope. In March, EPA announced issuance of a sweeping
and long-awaited proposal to modify the RCRA definition
of solid waste. The proposal seeks to streamline regulation
of so-called hazardous “secondary” materials,
and revise the all-important definition of solid waste
to exclude certain secondary materials, such as solvents,
metals and certain other chemicals, from RCRA regulation
to promote the legitimate recycling of such materials.
Lynn L. Bergeson, "Executive
Order Supports Alternative Fuel Use," Pollution
Engineering,
April 2007. On January 24, 2007, President Bush signed Executive Order
(EO) 13423, Strengthening Federal Environmental, Energy
and Transportation Management, which mandates that federal
agencies reduce oil consumption, use more alternative
fuels and curb greenhouse gas emissions. In his 2007 State
of the Union address, Bush announced plans to reduce U.S.
gasoline usage by 20 percent in 10 years. The EO also
renews the administration's commitment to environmentally
friendly procurement practices.
Lynn L. Bergeson, "Changing
the Guard: Implications of the Democratic Midterm
Election Win on Environment, Energy, and Resources
Legislation," Environmental
Quality Management, Spring 2007. The November 2006 mid-term elections
portend a number of significant Congressional changes.
There is no doubt that Democratic leadership in both the
House and Senate will shake things up. Some in the business
community are buckling their seat belts and preparing
for a bumpy ride. Here are a few thoughts on the shape
of things to come.
Lynn L. Bergeson, panel expert, "Emerging
Environmental Risk: A Global View," Risk
Talk: Environmental Risk, Vol. 1, Issue 2. This edition of Risk Talk focuses
on emerging environmental risks from a global perspective.
From local pollution problems to global warming, companies
face a wide variety of environmental risks. The increasingly
global economy requires that companies adopt a comprehensive
environmental risk management strategy. Properly executed,
such a strategy can give a company a competitive advantage.
Lynn L. Bergeson and Joseph
E. Plamondon, "TSCA and
Engineered Nanoscale Substances," Nanotechnology
Law & Business, March 2007. The federal law that regulates new and existing chemical
substances, including engineered nanoscale chemical substances,
is the Toxic Substances Control Act (TSCA). While there
is much debate over how the U.S. Environmental Protection
Agency (EPA) should deploy its significant TSCA authority
to address potential risks to human health and the environment
posed by engineered nanoscale materials, there is no doubt
that EPA is already doing so. This article provides a
general overview of TSCA as it relates to new and existing
chemical substances, and discusses how EPA may go about
discharging its significant TSCA authority with respect
to engineered nanoscale substances.
Lynn
L. Bergeson, "EPA Issues Final
SPCC Plan Amendments," Pollution
Engineering, March 2007. Last December, EPA issued final amendments to the Spill
Prevention, Control and Countermeasure (SPCC) plan requirements.
The final rule included new provisions outlining requirements
for various classes of oil, revised the applicability
of the regulation, and amended requirements for completing
the plans, among other modifications. EPA plans to add
further adjustments in 2007.
Lynn L. Bergeson, "'REACH'
Has Arrived: U.S. Manufacturers Need To Be Ready," Manufacturing
Today, January/February
2007.
Lynn L. Bergeson, "EPA's
'Tips' Website Is a Hit," Pollution
Engineering, February 2007. When the Senate Environment
and Public Works Committee confirmed Granta Nakayama
as Assistant Administrator of EPA’s Office of
Enforcement and Compliance Assurance (OECA), it was
unclear what his agenda might include. Few predicted,
then, that EPA’s top enforcement official would
reinvigorate the EPA tip website as a means for prompting
compliance.
Lynn L. Bergeson, "GHS:
Federal Agencies Step Up Efforts," Pollution
Engineering, January
2007. Now that
the United Nations has adopted the Global Harmonization
System of Classification and Labeling of Chemicals (GHS),
there is an international goal for as many countries as
possible to implement GHS by 2008. GHS is an important global
system of hazard classification, communication and labeling
which, if implemented, is expected to bring much needed
consistency and harmony to the workplace. Domestically,
federal agencies are stepping up efforts to get with the
program.
Lynn L. Bergeson, "EPA
Advances Voluntary Nanoscale Materials Stewardship Program," ABA
Pesticides, Chemical
Regulation, and Right-to-Know Committee Newsletter,
Vol. 8, No. 1, January 2007.
Over the past several months, the
U.S. Environmental Protection Agency (EPA) has made significant
progress advancing its Nanoscale Materials Stewardship
Program (NMSP).
Lynn L. Bergeson, "The
Chemical Safety and Hazard Investigation Board: Thinking
Strategically in Investigating (and Preventing) Chemical
Accidents," Environmental
Quality Management, Winter 2006. Chemical accidents are always
unwanted, and almost always the subject of considerable
media attention and public scrutiny. Investigating the
causes of chemical accidents is not an easy task, nor
is the job of communicating the results of such investigations.
Given the significant importance of the mission and day-to-day
work of the U.S. Chemical Safety and Hazard Investigation
Board (the "CSB" or "Board"),
whose job is to investigate and prevent accidents, the
release in August of its draft strategic plan for fiscal
years 2007-20121 received remarkably little fanfare. This "Washington
Watch" column provides some background on the CSB,
and outlines key elements of its draft strategic plan.
Lynn
L. Bergeson, "The
Globalization of Product Stewardship Is Under Way," Manufacturing
Today, November/December 2006. Product stewardship is critically
important these days as international stewardship initiatives
and directives involving specific products -- typically
consumer products -- are sprouting up everywhere. In Europe,
for example, several directives are likely to greatly influence
global product stewardship. Environmental regulation historically
has been expressed through command-and-control mechanisms
of governance.
Lynn L. Bergeson, "Get
Answers to Your Biomonitoring Questions," Chemical
Processing, November 2006. Guidance for chemical manufacturers,
processors, and distributors about Section 8(e) of the Toxic
Substances control act was issued on September 14, 2006,
by the U.S. Environmental Protection Agency (EPA). The guidance
is available in new Q&As at http://www.epa.gov/oppt/tsca8e/pubs/qatsca.htm.
Lynn L. Bergeson, "Getting
to Harmonization," Pollution
Engineering, November 2006. On September 12, 2006, the Occupational Safety and Health
Administration (OSHA) issued an advance notice of proposed
rulemaking (ANPR) for the implementation of the Globally
Harmonized System of Classification and Labeling of Chemicals
(GHS). The agency also made available a Guide to the Globally
Harmonized System of Classification and Labeling of Chemicals.
On October 18, 2006, the U.S. Environmental Protection
Agency (EPA) convened a public meeting to discuss the
GHS and pesticide labeling issues.
Lynn L. Bergeson, "Expect
Tighter Particulate Matter Standards," Chemical
Processing, October 2006. Particulate matter (PM) is
a hot button issue poised to raise business costs and
litigation. The U.S. Environmental Protection Agency
(EPA) was recently due to issue final PM standard revisions.
EPA last year proposed stronger National Ambient Air
Quality Standards (NAAQSs) for fine PM (2.5 micrometers
or less in diameter (PM2.5)) and the 24-hour PM2.5 standard.
However, EPA sought to keep annual PM2.5 NAAQS of 15 μg/m3.
EPA’s proposal was inconsistent with a Clean Air
Scientific Advisory Committee (CASAC) recommendation
to reduce standards to a 13 to 14 μg/m3 range. How
EPA decides to proceed and which standards it selects
are closely watched topics.
Lynn L. Bergeson, "EPA
Meets FQPA Deadline," Pollution
Engineering, October 2006. August 3, 2006, marked the end
of the 10-year deadline EPA was given under the 1996 Food
Quality Protection Act (FQPA) to complete a review and
reassessment of all tolerances (maximum permitted residues)
for all food use pesticides. The agency claims to have
completed over 99 percent of the reassessments. Despite
its important implications for domestic food safety, the
Federal Insecticide, Fungicide and Rodenticide Act (FIFRA),
as amended by FQPA a decade ago, remains one of the least
understood federal environmental statutes. EPA is responsible
for regulating the sale and use of pesticides, and the
allowable levels in and on food. Their authority is set
forth in FIFRA and the Federal Food, Drug and Cosmetic
Act (FFDCA), both of which were amended by FQPA. FIFRA
provides the overall framework for EPA’s regulation
of pesticides. The FFDCA governs the establishment of
pesticide tolerances for food and feed products.
Lynn L. Bergeson, "ABA
SEER'S Review of Existing Laws and Nanotechnology," Gradient
Corporation EH&S Nano News, October 2006. The American Bar Association
(ABA) Section of Environment, Energy, and Resources
(SEER) offered to brief representatives of the US Environmental
Protection Agency's (EPA) Office of General Counsel
on legal and regulatory issues arising in connection
with the application of existing statutory and regulatory
authorities to engineered nanoscale materials. SEER
prepared briefing documents on each statute, and a separate
briefing document on innovative governance mechanisms.
Each document identifies the legal and regulatory issues
EPA will likely encounter as it considers how best to
address issues arising in connection with nanotechnology.
All seven briefing documents, which are solely the product
of SEER and do not purport to represent the opinions
of EPA, are available at http://www.abanet.org/environ.
Lynn L. Bergeson, "Environmental
Accountability: Keeping Pace with the Evolving Role
of Responsible Environmental Corporate Stewardship," Environmental
Quality Management, Autumn 2006. This "Washington Watch" column
outlines the concept of environmental accountability, provides
a summary overview of the many mechanisms that are included
within this broad topic, and discusses the role that environmental
accountability plays in influencing corporate business standards
pertinent to environmental performance. As government resources
earmarked for more traditional environmental enforcement
and compliance-assistance initiatives continue to dwindle,
environmental accountability will increasingly serve as
a key driving force to compel higher standards of corporate
environmental accountability.
David B. Fischer, "Making
'the Best' Better: Toward a More Useful Method of Reporting," Risk
Policy Report, September
26, 2006. On October 29, 1999, EPA published
a final rule on reporting releases of persistent, bioaccumulative,
and toxic (PBT) substances under the Toxics Release Inventory
(TRI). This rulemaking was controversial for a host of
reasons, not the least of which was EPA’s decision
to create the astonishingly low reporting threshold of
0.1 grams for the newly added dioxin and dioxin-like compounds
category -- over 10,000 times lower than the next lowest
threshold level of 10 pounds. Facilities that inadvertently
manufacture dioxin and dioxin-like compounds above the
0.1 gram threshold, through combustion for example, may
now be subject to reporting release data and other waste
management information for this category of compounds.
In this rulemaking, and as described below, EPA chose
an uncommon method of reporting dioxin and dioxin-like
compounds, a method that EPA has recently acknowledged
is not the “best way.” After years of contemplating
a change, EPA is now poised to make the “best way” better.
Lynn L. Bergeson, "RoHS,
WEEE and Related EU Directives," Pollution
Engineering, September
2006. Product stewardship is becoming increasingly important
as international regulatory requirements involving product
lifecycles become more prevalent. In Europe, several directives
are likely to influence global product stewardship.
Lynn L. Bergeson and Michael F. Cole, "NanoBioConvergence
-- Emerging Diagnostic and Therapeutic Applications," Bioprocessing & Biopartnering
2006: Featuring NanoBiotechnology, 2006. Many people regard
nanotechnology as a "stand-alone" technology.
While the technology itself is of great interest, the
most intriguing aspect of nanotechnology is that it is
increasingly being utilised as an integral part of a more
complicated convergence matrix. The intersection of nanotechnology,
biotechnology, information technology, and cognitive science,
otherwise referred to as ‘NBIC convergence’,
is leading to the development of nanobiotechnology products
that promise to change radically the provision of healthcare
in the decades ahead.
Lynn L. Bergeson, "EPA Expands Mercury Reduction Program," Pollution Engineering, August 2006. Mercury is a naturally occurring metal found in the Earth’s crust. At high doses, mercury is known to cause adverse human health effects. Over the past several years, the U.S. Environmental Protection Agency (EPA) has focused on mercury exposures because of its potential to cause adverse human health and environmental effects, and because of its persistence and widespread distribution in the environment.
Lynn L. Bergeson, "Views from the Chair: The Section's Contributions to Nanotechnology," Trends: ABA Section of Environment, Energy, and Resources Newsletter, July/August 2006.
Lynn L. Bergeson, "Nanotechnologies and FIFRA," ChemADVISORY, July 2006. This column explores applications of nanotechnologies in the agricultural sector, and a few of the issues the U.S. Environmental Protection Agency's (EPA) Office of Pesticide Programs (OPP) is now considering regarding nanotechnologies and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
Lynn L. Bergeson, "Small Sensors Promise Big Impact," Chemical Processing, July 2006. In the past year, there has been an appreciable upswing in new products developed and commercialized pertinent to "intelligent" water monitoring tools and devices involving nanotechnology. Because many environmental applications of nanotechnology will almost certainly revolutionize the science, law, and regulation of water pollution, readers are urged to keep abreast of this fast-changing area.
Lynn L. Bergeson, "Key Environmental Issues: Views from Inside the Beltway and Beyond," Environmental Quality Management, Summer 2006. With the mid-term elections fast approaching, the Bush Administration is probably feeling a bit unsettled about its ability to defend its record on environmental accomplishments. The Bush Administration’s record on environmental accomplishments is, according to most environmental groups, weak if not downright bad. This column identifies several key environmental issues that may elicit potential voter response.
Lynn L. Bergeson, "The Coming of Low-Sulfur Diesel Fuels," Pollution Engineering, July 2006. In May 2006, the U.S. Environmental Protection Agency (EPA) published new rules expanding upon its earlier suite of rules requiring the reduction of sulfur content in diesel fuels. This column reviews generally the diesel rules, and provides an overview of the opportunities they present.
Lynn L. Bergeson, "National Partnership for Environmental Priorities: Rewarding Waste Minimization," Pollution Engineering, June 2006. The U.S. Environmental Protection Agency (EPA) seeks to reward efforts to reduce waste generation and emissions of chemicals that it believes are harmful. Its general strategy is to bestow public recognition and other rewards upon companies and other entities that choose to partner with it in a varied and growing number of partnership opportunities. This column describes one such partnership program, the National Partnership for Environmental Priorities (NPEP). This program is intended to recognize and publicly honor companies that choose to retool their operations to diminish the use or release of 31 priority chemicals.
Lynn L. Bergeson and Michael F. Cole, "FDA Regulation of Food Packaging Produced Using Nanotechnology," Food Safety Magazine, April/May 2006. Food packaging materials must comply with the provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA). Nanopackaging for the most part involves the use of materials that are not intended to have any effect on the food in the package, but may contact the food if the material migrates from the packaging. Such materials are regulated as indirect food additives or food contact substances. There are precedents that permit the marketing of indirect food additives without the need for clearance, and there is a regulatory process in place to review additives that require approval. The critical question in the food packaging area, as in every regulated industry, is whether existing precedents and process will be sufficient to address any issues that arise as the application of nanotechnology matures.
Lynn L. Bergeson, "Tapping into EPA Innovations," Pollution
Engineering, May 2006. The U.S. Environmental Protection
Agency (EPA) employs some of the most innovative scientists
in the world. The federal government takes an interest
in marketing the inventions that these world-class scientists
develop while employed by the federal government. A 1986
amendment to the Federal Technology Transfer Act (FTTA)
directed federal government agencies to allow inventors
to patent inventions if agencies elected not to do so.
EPA’s TechMatch
is a new patent website available at http://www.epatechmatch.com.
The public has access to view and search EPA patents to
facilitate partnership opportunities between non-federal
entities and EPA laboratories.
Lynn L. Bergeson, "Develop an Air-Tight Defense," Chemical Processing, April 2006. Plants are challenged now more than ever to control fugitive emissions. The emissions escape from valves, compressors, pumps, piping components, etc. Controlling them is often not easy, but failure to do so can lead to penalties and other liability. This column focuses on the challenges chemical processors face, but in many respects the pressure to control fugitive emissions are just as acute in other manufacturing sectors.
Lynn L. Bergeson, "EPA Proposes Tighter PM Standards," Pollution Engineering, April 2006. The U.S. Environmental Protection Agency (EPA) has been busy addressing particulate matter (PM), a mixture of very fine particles and/or liquid droplets to which exposure is, according to the agency, directly linked to health problems. In January, EPA proposed revisions to the primary and secondary national ambient air quality standards (NAAQS) for PM. On February 3, 2006, EPA issued an advance notice of proposed rulemaking (ANPR) for implementation of the NAAQS for PM.
Lynn L. Bergeson, "Nanotechnologies and FIFRA," Gradient Corporation EH&S Nano News, April 2006. This column explores applications of nanotechnologies in the agricultural sector, and a few of the issues the U.S. Environmental Protection Agency's (EPA) Office of Pesticide Programs (OPP) is now considering regarding nanotechnologies and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
Lynn L. Bergeson, "Nanoscale
Materials and TSCA: EPA's NPPTAC Recommends
a Framework for a Voluntary Program," Environmental Quality Management, Spring 2006.
The U.S. Environmental Protection Agency (EPA) National Pollution Prevention and Toxics Advisory Committee (NPPTAC) forwarded to EPA Administrator Stephen L. Johnson on November 22, 2005, its document entitled Overview of Issues for Consideration by NPPTAC. The Overview of Issues document sets forth NPPTAC’s “analysis and views” on
a framework for a voluntary program on existing engineered
nanoscale materials. The framework is intended to complement
the new nanoscale chemicals requirements promulgated under
the Toxic Substances Control Act (TSCA).
Lynn L. Bergeson, "EPA Proposes Lead-Based Paint Removal Requirements," Pollution Engineering, March 2006.
On Jan 10, 2006, the U.S.
Environmental Protection Agency (EPA) proposed extensive
requirements to minimize the introduction of lead hazards
resulting from the disturbance of lead-based paint during
renovation, repair and painting activities in most housing
built before 1978. The proposal introduced lead-based paint training, certification and safe work-practice requirements for contractors involved in these activities. According
to EPA, it is one component of a comprehensive program
to ensure the use of lead-safe work practices that will
also include training, and an education and outreach
campaign targeted at both workers and consumers.
Michael F. Cole, "RFID, Nano-Tools and the Electronic Safety Net: Nanotechnology may revolutionize the use of RFID in the battle against counterfeit drug imports," Health & Personal Care Magazine, February 2006. Radio frequency identification (RFID) technology is revolutionizing the business of tracking inventory and, soon, the U.S. Food and Drug Administration (FDA) will use it to combat counterfeit drugs. The challenges of RFID adoption, in turn, might act as an additional impetus to the development of nanotechnology solutions. FDA views RFID as the most promising technology to combat the flow of counterfeit drugs to U.S. consumers, and encourages the adoption of RFID by manufacturers and distributors.
Lynn L. Bergeson, "EPA's NPPTAC Recommends Framework for Voluntary Nanomaterials Program," ABA Pesticides, Chemical Regulation, and Right-to-Know Committee Newsletter, Vol. 7, No. 1, February 2006. In November 2005, the National Pollution Prevention and Toxics Advisory Committee (NPPTAC) forwarded to U.S. Environmental Protection Agency (EPA) Administrator Johnson its document entitled Overview of Issues for Consideration by NPPTAC. The Overview of Issues document sets forth the NPPTAC’s analysis and views on a framework for an approach to a voluntary program for existing engineered nanoscale materials. The framework is intended to complement the approach to the new nanoscale chemicals requirement under the Toxic Substances Control Act (TSCA), and is a must read for those wishing to stay abreast of nano developments.
Lynn L. Bergeson, "EPA Proposes Amendment to SPCC Plan Requirements," Pollution Engineering, February 2006. On December 12, 2005, EPA proposed
to amend Spill Prevention, Control, and Countermeasure
(SPCC) plan requirements to reduce the regulatory burden
these requirements impose on covered entities. EPA also
released a document entitled SPCC Guidance for Regional
Inspectors to assist regional inspectors in assessing
a facility’s implementation of SPCC requirements.
As such, the document is an important how-to guide for
ensuring compliance with SPCC plan requirements.
Lynn L. Bergeson, "Mercury
Rising: EPA Regulates Emissions for Power
Plants," Pollution Engineering, January 2006. The Clean Air Act (CAA) established a deadline for the U.S. Environmental Protection Agency (EPA) to decide whether and how to regulate mercury emissions from coal-burning electric utilities. As several public interest groups had earlier sued EPA over the perceived inaction, the agency was required under a settlement agreement to issue a final rule by December 2004. This date was later extended to March 2005. EPA issued a rule to permanently cap and reduce mercury emissions from coal-fired power plants on March 15, 2005.
Lynn L. Bergeson, "GAO Recommends TSCA Improvements, and a Senate Bill Responds with a Proposal," Environmental Quality Management, Winter 2005. In June 2005, the Government Accountability Office (GAO) issued a report critical of the federal government’s ability under the Toxic Substances Control Act (TSCA) to assess and prevent risks from new and existing chemical substances. Release of the GAO report coincided with the introduction by Senators Frank Lautenberg and James Jeffords of the Kid Safe Chemicals Act (S. 1391), a bill intended to improve children’s health by reducing exposure to harmful toxic chemicals in everyday consumer products and otherwise address the deficiencies in TSCA outlined in the report. This column reviews the GAO report, the proposed Kid Safe Chemicals Act, and the outlook for both.
Lisa M. Campbell, "Rhetoric That Hides the Issues at Stake," The Environmental Forum, November/December 2005. The debate over whether human data should be used to assess potential risk from chemical products, and in particular pesticide products, has been raging for at least seven years. Before it became controversial in the late 1990s, EPA routinely relied on studies of human subjects for some pesticide products and many other substances, and, in fact, acknowledged, along with many other government agencies and other scientific entities, the superiority of such studies in evaluating potential risks to humans.
Lynn L. Bergeson, "Proposed Rule on Human Studies," Pollution Engineering, November 2005. On Sept. 12, 2005, EPA issued its human studies proposed rule, and led a stakeholder briefing on the proposal on Sept. 7. The proposed rule focuses on third-party intentional dosing studies involving pesticides, although EPA seeks comment on alternative approaches with a broader scope. The rule, as proposed, would prohibit new third-party intentional dosing studies for pesticides involving pregnant women or children as subjects, as well as all first- and second-party intentional dosing studies of any substance involving pregnant women or children as subjects.
Lynn L. Bergeson, "Hurricane Havoc Has Hit Regulators, Too," Manufacturing Today, September/October 2005. Hurricanes Katrina and Rita have inspired environmental havoc and strained the capacity of every government agency impacted by these natural disasters. According to some, this is only the beginning. The aftermath of these storms has everyone’s attention now, especially the U.S. Environmental Protection Agency (EPA) and the state and local government agencies that must now deal with the aftermath. Issues include EPA's environmental priorities; health and infrastructure; EPA authority to waive environmental statutes and regulations; and collateral EPA impacts.
Lynn L. Bergeson, "HPV
Challenge Program: EPA Goes After Orphan Chemicals," Pollution Engineering, October 2005 "EPA recently posted
on its Chemical Right-to-Know website a new policy,
entitled Policy Regarding Acceptance of New Commitments
to the High Production Volume (HPV) Challenge Program,
available at www.epa.gov/chemrtk/hpvpolcy.pdf.
The policy outlines how companies can commit to sponsor
any of the remaining so-called 'orphan chemicals,' which
include the 300 chemicals that are currently unsponsored
under the HPV Chemical Challenge Program."
Lynn L. Bergeson, "EPA Considers How Best to Regulate Nanoscale Materials," Environmental Quality Management, Autumn 2005. "In a May 10, 2005, Federal Register notice, EPA announced, in an understated way, its
decision to convene a public meeting on 'nanoscale materials.' The meeting notice represents
the Agency's first public foray into harnessing some of nanotechnology’s promise within a
regulatory framework created almost three decades ago with the enactment of the Toxic
Substances Control Act (TSCA)."
Lynn L. Bergeson, "TSCA and Nanoscale Materials Update," ABA Pesticides, Chemical Regulation, and Right-to-Know Committee Newsletter, Vol. 6, No. 4, August 2005.
