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#41 -- Can GMOs Be Contained?, 7-Jun-2006

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Rachel's Precaution Reporter #41

"Foresight and Precaution, in the News and in the World"

Wednesday, June 7, 2006..............Printer-friendly version
www.rachel.org -- To make a secure donation, click here.
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Table of Contents...

Can Genetically Modified Crops Be Contained? Many Say No.
Can genetically modified (GMO) crops coexist with normal crops
without causing genetic contamination? Many people now say No. The
biotech industry favors global contamination, and once contamination
occurs, it can't be reversed, so a precautionary approach is the only
hope for preserving the world's stock of non-GMO crop genes.
European Chemicals Policy Is Driving Innovation Worldwide
In Europe, the precautionary approach to toxic chemicals in
electronic devices is driving innovation worldwide. Instead of
"precautionary principle," you might call it the ingenuity principle.
Proposed Risk Assessment Guidelines Would Snarl Government
The White House has found a way to bring government regulation to a
crawl, and perhaps a halt: delay governmental action until a high
degree of scientific certainty has been achieved in the risk
assessments that accompany new regulations.
Kaiser Permanente Adopts Comprehensive Chemicals Policy
In 2005, Kaiser Permanente, the largest U.S. health maintenance
organization, with headquarters in Oakland, California, adopted the
precautionary principle to guide its purchase, use and disposal of
chemicals.
Editorial: We Need to Work Together to Conserve Fish
"As we attempt to preserve habitat, we should follow the
precautionary principle: Even if science has not yet determined every
last detail of how a habitat nurtures fish, if we have strong evidence
that it's essential, we must preserve it."
Opportunity to Offer Precaution Workshop for Scientists
The Centers for Disease Control and Prevention in Atlanta has
issued a "call for workshops" for its National Environmental Public
Health Conference, Dec. 4-6, 2006. We are told that workshops on the
precautionary principle would be welcome. Who will step up to the
plate?

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From: New York Times, Jun. 6, 2006
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QUESTIONS ON BIOTECH CROPS WITH NO CLEAR ANSWERS

By Elisabeth Rosenthal

AUBINS, Spain -- Enric Navarro was dumbfounded when the letter arrived
from the testing lab of the Spanish organic farmers association in
late February, telling him his organic crop actually contained 12
percent genetically modified corn.

For Mr. Navarro, finding plants modified by biotechnology was almost
as traumatic as finding nuclear waste would have been. For four years,
he had lovingly planted hundreds of varieties of trees, shrubs,
flowers and herbs to attract just the right mix of insects so he would
not need fertilizers or weed killers on his precious seven hectares
(17.3 acres).

"If I could not farm organic, I would not farm," said Mr. Navarro,
dressed in sweatpants and a stained T-shirt as he sipped coffee in his
shed. "I could not sleep at night if I sold that crop."

He decided to burn the corn still in the field, to rid his farm of
what he called a "contaminant." But he is still not certain how the
unwanted seed got onto his property. There is no way to claim
compensation for his economic losses. And he is not sure when it will
be safe to use the field for his form of organic farming.

As the European Union begins opening its doors wider to genetically
modified crops, Mr. Navarro's byzantine experience serves as a
cautionary tale about the uncertainties surrounding the lack of
policies to deal with the problems that will almost certainly arise.

"There is a lot that hasn't been worked out," said Julian Kinderlerer,
of the Institute of Biotechnical Law and Ethics at the University of
Sheffield in England, who has advised the European Union on the issue.

For eight years, Spain was the only country in the union to permit
commercial cultivation of genetically modified crops. But in the last
18 months, the European Commission has approved 11 genetically
modified seeds for planting in the union, and in 2005, France,
Germany, Portugal and the Czech Republic began planting small
commercial plots.

In the United States, the vast majority of large commercial farms
plant genetically modified crops, like corn or soy, and there is no
general effort to distinguish those from nonbiotech crops and foods in
farming or food processing.

But the cornerstone of the European Union's new open-door policy is
the political conviction that it is possible for genetically altered
crops and conventional crops to coexist separately within Europe with
proper safeguards, like keeping a distance between fields and imposing
a liability system for accidents.

Scientifically, there are strong disagreements about whether
"coexistence" is possible, at what cost and even how it should be
defined.

"Coexistence is feasible in the vast majority of places, so long as
farmers talk to each other and cooperate," said Simon Barber of
EuropaBio, an industry group in Brussels. He said that experiences
like Mr. Navarro's should be rare.

But many scientists, and not just those with green credentials, think
coexistence is not feasible in many European countries, where small,
closely spaced farms are the norm.

"My experts all agreed that coexistence often just doesn't work," said
Chantal Line Carpentier, an agricultural economist who led a panel of
experts that studied the issue under the North American Free Trade
Agreement.

The study was requested by Mexico in 2002, after genetically modified
corn was found in fields in Oaxaca, hundreds of miles from the United
States. Mexico feared that the heartier modified variants would edge
out its unique native strains.

That report, "Maize and Biodiversity," released in 2004 by the North
American Commission on Environmental Cooperation, concluded that the
genetically engineered corn might well have a long-term effect on
Mexico's ecology and biodiversity and that it should be better studied
and monitored.

The United States and Canada attacked its conclusions. But some
farmers said the report did not go far enough. "Saying that G.M. and
non-G.M. farming can coexist is nonsensical," said Julian Rose, an
organic farmer from England. "It's like saying that noise and silence
can coexist in a room."

The scientific disagreement over coexistence is also partly a question
of definition: the biotech industry and new regulations proposed by
the European Union would permit some degree of inadvertent
intermixing.

The biotech industry considers "coexistence" achieved if mixing is
below 0.9 percent and, under proposed regulations, foods in the
European Union could be labeled free of genetic modification if they
contained less than this amount.

Such labeling is not required in the United States, where the two
types of product are regarded as essentially equivalent.

"I think that it's great we are able to commingle all types of corn,"
said Michael J. Phillips, a vice president of the Biotechnology
Industry Organization in Washington. "That allows us to sell it at low
cost and feed the world."

The concept of coexistence is problematic because there are simply too
many ways that mixing occurs, experts said. Wind blows seeds, mills
grind crops from different farms, a cookie contains oil made from
imported genetically modified soy. The genetically engineered corn in
Oaxaca was probably the progeny of corn ears that had been legally
imported for animal feed but whose kernels had been illegally used for
planting.

With so many routes, environmental groups say, the 0.9 percent limit
will inevitably be breached.

Mr. Phillips acknowledged that keeping modified and nonmodified crops
apart in fields or in the market was expensive and he ruled out
industry compensation. "If you're a small farmer trying to
differentiate your product," he said, "the onus is on you to pay for
the needed separation."

Last year, Greenpeace tested 40 organic farms in Catalonia. Nearly 20
percent had contamination, from 0.7 percent to 12 percent.

Spain decided to admit cultivation of genetically modified crops in
1998. Twelve percent of corn is now biotech -- about half of it in
Catalonia.

Mr. Navarro's two fields are 70 and 100 meters from neighbors' farms,
a distance often deemed adequate to prevent mixing. But it was windy
last winter, and perhaps some seed blew in, he speculated.

There is no log of who plants genetically modified seeds and nowhere
to turn for compensation for his economic losses. Neither the
Agriculture Ministry nor the organic farmers association could provide
guidance on how to clean up a contaminated field.

Mr. Navarro recently prepared a field in the center of his property
for planting corn, hoping that distance and the rows of shrubs will
protect it. If not, he says, he will quit.

Copyright 2006 The New York Times Company

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From: Boston Globe, Jun. 1, 2006
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TECH FIRMS FACE EU TOXICS TEST

Limits on the use of hazardous materials pushes US electronic makers
to innovate


By Hiawatha Bray, Globe Staff

A tough European Union law that limits toxic substances in electronic
devices takes effect on July 1, and US companies that want to do
business across the Atlantic are racing to comply, spending billions
of dollars to redesign their products.

"This is probably the biggest change in electronics in 50 years,"
said George Wilkish, senior quality engineer at M/A-Com Inc., a
business unit of Tyco Electronics Corp ., in Lowell that makes a
variety of radio and microwave components for communications gear.

Many electronic devices, like computer circuit boards and cathode ray
tubes, are crammed with substances that can cause serious health
problems if ingested. Lead can cause brain damage and pregnancy
complications, for example, and cadmium can cause kidney disease. To
prevent these poisons from ending up in landfills, EU regulators took
a two-tiered approach. A law that took effect last year requires
electronics firms to recycle their products, and the EU also enacted
RoHS -- the Restriction of Hazardous Substances Directive-- to
eliminate lead, cadmium, mercury, and three other toxic chemicals from
electronic devices.

The federal government sets no limits on the chemicals used in
electronics, but the power of RoHS extends far beyond Europe.

US companies must comply to retain their European customers. And after
spending millions to eliminate the substances, companies like M/A-Com,
which makes about 20 percent of its sales in Europe , plan to sell
their cleaner products not just to European clients, but also to
customers in the rest of the world.

Dick Anderson, senior principal engineer at M/A-Com's research and
development group, said the approximately $1 million cost of complying
with the European law will be good for business.

"In addition to doing this because it's the law, we're doing it
because it differentiates us," Anderson said. He figures that even US
customers will choose M/A-Com's components over those made by rivals
who haven't been as quick to clean up.

Other Massachusetts technology firms don't think they'll profit from
obeying the European standard because they expect their competitors to
comply as well. "There's no economic benefit we can derive from
this," said Denny Lane, director of product management at Stratus
Technologies Inc. of Maynard, a maker of computers and data storage
systems. "We can't say, 'We're green and you're not.' "

Still, Lane, who holds a degree in environmental biology, favors the
EU standards, even though compliance has cost his company "hundreds
of thousands" of dollars. "This is important," said Lane, "maybe not
for my kids, but my kids' kids."

America's biggest consumer electronics firms are also committed to
compliance. Leading desktop computer maker Dell Inc. says its product
line is almost all Euro-ready. Apple Computer Inc. said that its iPod
Nano and Shuffle music players meet the European standard and that all
Apple products will comply with the EU regulations by July 1.

Many businesses won't reveal exactly how much they've spent on RoHS
compliance. But Pamela Gordon, president of Technology Forecasters
Inc., a consulting firm in Alameda, Calif., estimates that US
electronics firms will spend a total of $3.5 billion.

Kenneth Stanvick, senior vice president and co-founder of Design Chain
Associates LLC in Pelham, N.H., said that some smaller electronics
firms haven't complied with the EU regulations, and hope to slip past
European regulators undetected. "It's risk management," he said.
"What are my chances of getting caught?"

But the odds against scofflaws will only get worse. China plans to
enforce an even stricter law beginning next March; South Korea will
set similar standards starting next July. And California has enacted
its own standards, which take effect in January.

Attempts to evade government regulations are a waste of time, said
Gordon of Technology Forecasters, "The astute electronics industry
executive realizes that environmental requirements are here," Gordon
said. "They're not going anywhere--they're going global."

Compliance with the new EU rule has not been easy. Boston modem maker
Zoom Technologies Inc. had to cancel a new product planned for the
European market because it couldn't be made in compliance with the
law.

"It turns out there's this one chip that we can't get," said Zoom
president Frank Manning . The only available version of the vital chip
contained toxic chemicals, and Zoom's order wouldn't have been large
enough for its maker to justify making a clean version.

A half-century ago, new soldering techniques enabled the mass
production of today's cheap electronic equipment. Today, the challenge
is to keep producing a vast array of electronic devices without
depending on lead solder. The alternatives, mostly based on tin,
require far hotter temperatures, which in turn can cause circuit
boards and other components to melt or crack. Switching to tin solder
not only requires new soldering gear, but also product redesigns, and
exhaustive testing of the finished components. At M/A-Com, engineers
test the lead-free components under vibration and extreme heat and
cold , then study the results under microscopes, in search of fatal
defects just a few microns in size.

Even so, tin solder still isn't as reliable as lead. So lead solder is
still permitted in devices with military and aerospace applications,
and in heavy-duty computer servers made by companies such as Stratus.
Even these exceptions will be reviewed every four years -- and
eliminated when European authorities judge that lead-free solders have
become more reliable.

Hiawatha Bray can be reached at bray@globe.com.

Copyright Copyright 2006 The New York Times Company

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From: Chemical & Engineering News (pg. 45), Jun. 5, 2006
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GUIDELINES FOR ASSESSING RISK

White House proposal could impede broad range of government
activities, agency representatives warn


By Cheryl Hogue

A White House plan for standardizing risk assessments across the U.S.
government is well-intended, representatives of federal agencies told
a National Research Council (NRC) committee late last month. But as
laid out in January by the President's Office of Management & Budget
(OMB)
, the proposal is likely to snarl government action, they
warned, giving plenty of examples.

Adherence to the proposed guidelines, they said, could deter the Food
& Drug Administration from telling the public about serious health
effects from a prescription drug. Or impede the National Institutes of
Health from providing guidance to health professionals about handling
blood from patients with HIV. Or slow down the Department of
Agriculture's assessments of whether a low-income pregnant woman,
infant, or young child is at risk of insufficient nutrition and thus
qualifies for supplemental foods provided by the government. Or hamper
the Occupational Safety & Health Administration's ability to issue
informational bulletins about potential workplace hazards. Or cause
the National Aeronautics & Space Administration to ditch years of work
compiling detailed risk assessment procedures that are highly specific
to space missions.

OMB's draft bulletin is designed to set minimum standards for the
scientific quality of federal agency assessments of risk to human
health, safety, or the environment. The guidance would require
agencies to describe the methods, assumptions, and uncertainties in
calculating a risk assessment and to provide a range of risk
estimates. It would apply to risk assessments performed for regulation
of pollutants, approval of new pharmaceuticals, and development of
safety systems for nuclear and chemical plants, liquefied natural gas
terminals, and space shuttles (C&EN, Jan. 16, page 6).

OMB asked NRC to review the proposal and to make suggestions for
improving it. The NRC committee reviewing the plan held its first
public meeting on May 22 to gather information. Members of the panel
got an earful from agency officials as well as from representatives of
academia, industry, and public interest groups.

John D. Graham, credited as the chief architect of the risk assessment
proposal, said the guidelines would apply to risk assessments done for
regulation, such as Environmental Protection Agency controls on
chemicals. They would also cover deregulation, such as the U.S.
decision to accept shipments of Canadian beef again after Canada put
systems in place to prevent mad cow disease, he said. The bulletin is
an internal guidance document that sets out OMB's expectations of how
agencies are to operate, he said.

Graham, who was the administrator of OMB's Office of Information &
Regulatory Affairs (OIRA)
from 2001 until earlier this year, is now
dean of the RAND Graduate School in Santa Monica, Calif.

Representatives from federal agencies said they supported the broad
goals of the bulletin, but most also laid out specific concerns about
how the proposal could inhibit key activities.

Steven K. Galson, director of FDA's Center for Drug Evaluation &
Research
, said OMB's bulletin would enhance the quality of his
agency's risk assessments. But it also may deter the agency from
activities that are important for protecting public health, he said.

For instance, the proposal's definition of risk assessment is too
broad, capturing activities that are not intended as formal risk
assessments, Galson said.

This broad definition could have serious impacts on FDA's getting
critical information to physicians and patients quickly about drugs,
medical devices, or foods, Galson said. He pointed out that this kind
of risk information is used not by federal regulators but by doctors
and patients to select the best course of action for patients.

For instance, FDA may, in the interest of protecting public health,
wish to inform the public about an adverse effect from a drug before
the agency can, through a formal risk assessment, define the
relationship between dose and outcomes, he said. Such a situation
occurred in June 2005 when FDA alerted the public about potential
suicidal thoughts and behavior in adults being treated with
antidepressant medications. The agency did so before it had completed
a formal review of the issue, which is still in process.

In addition, the agency is concerned that the OMB bulletin could
hamper FDA response to diseases that require rapid action, such as a
pandemic flu, Galson said.

The bulletin needs to distinguish "discovery research," such as
studies conducted by NIH, from risk assessments prepared by regulatory
agencies, said Christopher J. Portier, associate director for risk
assessment at the National Institute of Environmental Health
Sciences
. Because they identify hazards associated with chemicals,
human health studies and toxicology tests may eventually feed into
risk assessments conducted by regulatory agencies, he pointed out. But
the studies themselves, as well as National Toxicology Program
products, such as the congressionally mandated report on carcinogens,
need to be explicitly excluded from the bulletin's sweep, he said.

Meanwhile, many of the risk assessments done by USDA affect regulatory
actions pertaining to pests, diseases, safety of meat and poultry, and
release of genetically engineered organisms and would fall under the
proposed guidelines, said Linda Abbott, USDA senior scientist for risk
modeling. The department, however, is most concerned about whether the
OMB bulletin would apply to evaluations of people who may be eligible
for benefits under WIC, the Special Supplemental Nutrition Program for
Women, Infants & Children.

The proposal could also apply to assessments done to determine the
risks of individual farmer's fields to erosion and for other
environmental impacts. If the planned standards cover assessments of
such individual needs, some activities of the department could face
serious delays, she told the NRC committee.

Similarly, OSHA uses risk assessments almost exclusively for its
regulatory actions, said William Perry, acting deputy director of the
agency's standards and guidance directorate. The bulletin would apply
to those risk assessments. However, OSHA is unsure whether the
guidelines would also affect the nonregulatory, informational
bulletins that it issues occasionally about workplace hazards, Perry
said. For instance, OSHA and EPA in 2000 jointly issued an
informational bulletin warning about a little-known risk from molten
2,4-dichlorophenol (C&EN, May 1, 2000, page 49).

EPA is the agency rumored to be the main target of the OMB bulletin.
George M. Gray, the agency's science adviser, said, though, that EPA
"is in pretty good shape" for complying with the planned risk
assessment guidelines. The proposal, however, does not address how
interagency disputes over risk assessments will be resolved, Gray told
the NRC committee.

EPA has found itself at odds with other agencies in some of its
chemical-specific assessments. Notably, the agency's preliminary
drinking water standard for perchlorate came under heavy fire from the
Pentagon, the Department of Energy (DOE), NASA, and their contractors,
all of which face liability for pollution from this component of
rocket fuel and wanted a more relaxed standard. Eventually, NRC got
involved in the dispute and offered a safe daily dose number that was
higher than EPA's but would translate into a lower drinking water
standard for perchlorate than suggested by the military (C&EN, Jan.
17, 2005, page 13
).

Gray and Homayoon Dezfuli, manager for system safety at NASA's Office
of Safety & Mission Assurance
, pointed out that their agencies have
developed their own policies and procedures for risk assessments.
OMB's draft bulletin is silent on the role of these agency-specific
guidelines.

Dezfuli added that some of the proposal's standards are of limited
applicability to the agency's risk assessments or are inconsistent
with NASA's formal risk assessment procedures, which represent years
of effort. Harmonizing NASA's procedures to the ones proposed by OMB
would be a difficult task, he added.

In contrast with many agencies' worries about OMB's bulletin, Shannon
E. Cunniff, director of emerging contaminants at the Department of
Defense (DOD), indicated no concerns about the proposed standards to
the NRC panel.

The plan would apply to many of the military's risk assessments, she
said. Most focus on occupational issues, ranging from explosive safety
to the air quality inside submarines, but DOD also does site-specific
assessments of the risks from contaminants at its facilities, Cunniff
said. She added that the military is still trying to determine whether
the bulletin would be applicable to weapons safety.

Al Cobb, senior policy adviser in DOE's Office of Policy &
International Affairs, said his department probably has "the least
interest" in the bulletin among federal agencies because it has
virtually no regulatory role. However, DOE is interested in seeing
consistency among risk assessments in the government, he said.

John F. Ahearne, chair of the NRC committee, suggested that the
bulletin may affect DOE risk assessments done in connection with the
cleanup of sites such as the Hanford Nuclear Reservation in
Washington. Ahearne is director of the ethics program at Sigma Xi, the
scientific research society.

Meanwhile, it is unclear how OMB would ensure that agencies comply
with its risk assessment guidelines. The committee asked Nancy Beck, a
toxicologist and risk assessor at OIRA, about the consequences for an
agency that does not follow the guidelines. She responded, "We haven't
gotten that far."

Graham, the former OIRA chief, told the panel that OMB is "not
toothless" in ensuring that agencies follow its bulletins because OMB
determines agencies' annual budgets.

The committee also heard critiques of the proposal from those outside
the government. The draft bulletin uses a definition of risk
assessment that is broader than the standard one, which is "the
probability as well as the severity of risk," said Gilbert S. Omenn,
professor of medicine, genetics, and public health at the University
of Michigan Medical School. He chaired a congressionally mandated
commission that produced a 1997 report delineating the appropriate
uses of risk assessment and risk management in federal regulation.

"OMB has tried to put too much in there," agreed Alan J. Krupnick, a
senior fellow at Resources for the Future. He and Omenn, however,
endorsed the draft bulletin's intent of improving risk assessment
throughout the government.

Risk assessment, Omenn said, is distinct from the identification of
hazard presented by a commercial chemical, drug, or other agent, Thus,
he said, risk assessment does not include identification of hazards,
toxicology studies, structure-activity relationships, modeling, or
epidemiology studies. All of these, he said, are "preliminary" to risk
assessment. Omenn urged that the final version of the bulletin clearly
state that research on hazards does not fall under the proposed
guidance.

The NRC committee also heard a variety of arguments about one
particular provision in the draft guidelines. This part would require
federal risk assessments to provide a range of risk estimates, from
what some describe as the "worst case" to the "best case."

Cunniff endorsed ranges instead of a "point estimate," a single number
in an assessment reflecting the best judgment on what the risk is most
likely to be. Although risk managers tend to prefer a single point
estimate, this provides "a false sense of precision that can be
misleading to the public," she said.

But point estimates are appropriate because they are provided through
the expert judgment of risk assessors, said Robert Shull, director of
regulatory policy at watchdog group OMB Watch. Providing "mushy
ranges when point estimates are needed" inappropriately hands over
part of the risk assessor's job to policymakers deciding how to manage
risk, he said.

Judith A. Graham, managing director of the American Chemistry
Council's
long-range research initiative team, said ranges of risk
can be useful to risk managers. "I don't see how information is bad as
long as it doesn't cause paralysis by analysis," she said.

Jennifer Sass, a senior scientist at the Natural Resources Defense
Council
, said scientists within agencies often have expertise
specific to a narrow subject or location. The bulletin, by setting
government-wide standards, would strip these scientists of their
ability to provide expert judgments to agency decisionmakers, she
said. Shull agreed, saying the proposal would shift such judgments
from agencies to OMB.

The bulletin puts the onus on agencies to justify the risk assessments
underlying their regulatory decisions. Omenn and Sass pointed out,
however, that it explicitly excludes analyses by companies seeking
licenses, approvals, permits, and registrations from the federal
government. "I think that might be revisited," Omenn said.

ACC's Graham argued that the proposed standards should cover risk
assessments for agencies' overall policies for licensing, permitting,
or other approval, but not for those affecting decisions on companies'
products.

Lorenz Rhomberg, a principal at Gradient Corp., an environmental
consulting company, expressed concern about the proposal's broad call
for agencies to describe uncertainties in risk assessments. It is
difficult to deal with uncertainty comprehensively, he said, because
"someone can always think up" another factor that the assessment has
not addressed. Also, no scientific standards exist for analysis of
uncertainty. Rhomberg added that simply laying out uncertainties
without suggesting which are the most important is not helpful to
decisionmakers.

Sass noted that although the bulletin contains some positive aspects,
it lays out a burdensome approach that will hamper agencies from
taking regulatory action.

ACC's Graham, in contrast, had only praise for the bulletin. "The
bulletin is essential," she said, adding that it "will invigorate the
scientific community that has advanced the knowledge of chemicals and
ways to assess them only to be frustrated when that knowledge and more
sophisticated practice was not used" by agencies.

John D. Graham, the former OMB official, said the draft risk
assessment bulletin is likely to be revised in light of the NRC
committee's comments. Those are expected later this year.

Copyright 2006 American Chemical Society

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From: Kaiser Permanente, Mar. 23, 2005
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KAISER PERMANENTE ADOPTS COMPREHENSIVE CHEMICALS POLICY

Vision:

Kaiser Permanente aspires to create an environment for its workers,
members and visitors that is free from the hazards posed by chemicals
that are harmful to humans, animals and the environment.

Alignment with KP Values:

Linkages to Kaiser Permanente's Mission

KP's mission is to provide affordable, high-quality health care
services to improve the health of our members and the communities we
serve. Our concern for the health of our communities extends to the
air we breathe and the water we drink. (KP 2002-03 Annual Report)

KP's Environmental Stewardship Vision

We aspire to provide health care services in a manner that protects
and enhances the environment and health of communities now and for
future generations.

Alignment with Externally-Developed Environmental Concepts:

The Precautionary Principle

When an activity raises threats of harm to the environment or human
health, precautionary measures should be taken even if some cause and
effect relationships are not fully established scientifically. (From
definition created at the Wingspread Conference on the Precautionary
Principle, January, 1998.)

Extended Producer Responsibility (EPR)

EPR is an environmental policy approach in which a producer's
responsibility, physical and/or financial, for a product is extended
to the post-consumer stage of a product's life cycle. Manufacturers
should have a responsibility for the health impacts of the chemicals
they use and the products they create. Purchasers of these products
and chemicals have the right to request safety testing and full
disclosure of the results. Two key features are: (1) the shifting of
responsibility (physically and/or economically, fully or partially)
upstream to the producer and away from municipalities and purchasers,
and (2) to provide incentives to producers to take environmental
considerations into the design of the product. (The Organization for
Economic Co-operation and Development, 1994 Guidance Manual)

Issues:

1. In the U.S. we are experiencing alarming increases in chronic
diseases. Cancer, asthma, birth defects, developmental disabilities,
autism, endometriosis, and infertility are becoming increasingly
common. Mounting evidence links incidence and severity of these
diseases to environmental toxicants.

2. Lack of information from manufacturers of products used in health
care about all chemicals, ingredients, and processes used in
manufacturing.

3. Lack of safety testing to identify health and environmental impacts
for the majority of industrial chemicals.

4. Burdens faced by users (KP) due to the lack of information:

** ascertaining potential health impacts of products

** conducting assessments of products (resources, expertise, data)

** public concern

** research work and testing required of purchasers that want to
ensure products and chemicals are safe

** making product selection decisions without adequate information

** continued use of potentially hazardous materials

** potential liability

** unpredictable regulatory climate

** costs to organizations due to above listed burdens

5. Underclassification or mischaracterization of hazardous compounds.

Actions:

We will take the following actions to achieve our vision:

Internal focus

** Identify high priority chemicals and chemical groups; regularly
update and prioritize this data resulting in a living list of
chemicals of concern

** Conduct an inventory of product standards for presence of chemicals
of concern

** Understand cost implications of substitutions and incorporate cost
of ownership model into purchasing systems

** Communicate preferences to GPO, vendors and manufacturers

** When appropriate, communicate desired alternatives and reasons to
employees, members and the communities we serve

** Continue to pursue green building activities

** Develop goals and metrics to measure progress and include
mechanisms for sharing successes and lessons with the public

Contracting focus

** Create appropriate contractual obligations with manufacturers,
suppliers and distributors to:

** avoid identified chemicals of concern

** conduct and share results of extended toxicity testing

** disclose processes that use chemicals of concern even if the
chemicals used in the processes are not a part of the end product

** Substitute safer alternatives identified through hazard analysis

** Integrate a cost-of-ownership approach to assessing alternative
products

External focus

** Support sound public policies that promote greater evaluation of
chemicals and public disclosure

** Influence manufacturers to provide materials disclosure and
performance of safety tests

** Promote labeling of products with all ingredients

** Influence medical research into less hazardous clinical and
laboratory products and processes

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From: New York Newsday, Jun. 6, 2006
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EDITORIAL: WE NEED TO WORK TOGETHER TO CONSERVE FISH

On the way from the deep to our plates, the life journey of fish
depends heavily on preservation of the habitat that produces them. So
the struggle over habitat is vital to the well-being of our seas and
the survival of the fishing industry.

That fight takes many forms.

The Sustainable Fisheries Act of 1996, which updated the 1976
Magnuson-Stevens Act, ordered the regional fishery management councils
to designate and protect essential fish habitat for federally managed
fish species. That gives councils a powerful tool for commenting on -
and even influencing -- actions by other agencies that might harm
habitat. But it's a tool not always used. So environmental groups have
more than once sued the federal fishery bureaucracy for failing to
consider habitat sufficiently.

One suit involved tilefish, a major species for Montauk. In crafting a
management plan, the Mid-Atlantic Fishery Management Council did
examine whether some fishermen, using trawling gear to chase other
fish, are hurting tilefish burrows. The council found insufficient
evidence of damage to burrows. So the Natural Resources Defense
Council sued in 2001, arguing that the analysis was defective, and the
government should have protected the habitat. The NRDC lost, but there
will be other suits, here and elsewhere.

Another habitat protection strategy, not yet widely enough used, is
the designation of marine protected areas, where fishermen either
can't fish at all or can't use gear that would damage habitat. One
ardent advocate of this is right here on Long Island: David Conover,
the dean of the Marine Sciences Research Center at Stony Brook
University.

When commercial fishermen hear "essential fish habitat," they fear
closure of areas where they've fished for years. When recreational
fishermen hear "marine protected area," that sounds to them like
closure too. So some recreational fishermen have been pushing for
"freedom to fish" legislation, to block the designation of protected
areas. So far, it hasn't made much headway. Nor should it.

After all, marine protected areas are not exactly new. Rod Fujita, an
Environmental Defense expert on this, points out that, for centuries,
Pacific Islanders took that holistic approach, to conserve the
precious resource that kept them alive. There's no reason it can't
work now. In fact, in the North Pacific region, 380,000 square
nautical miles of ocean, the size of New England, are already
protected from bottom trawling.

Habitat issues are not easy. For example, it seems like just common
sense to say that we should protect coral formations, the nurseries
for many species, from trawling gear damage. Fishermen argue that no
sane fisherman would hurt coral -- but some fishermen must be doing
it.
The advocacy organization Oceana has strong before-and-after
photographic evidence.

As we attempt to preserve habitat, we should follow the precautionary
principle: Even if science has not yet determined every last detail of
how a habitat nurtures fish, if we have strong evidence that it's
essential, we must preserve it.

In addition to conserving fish, we must protect fishing communities.
So, if habitat preservation requires a reduction of trawling, policy
makers must find ways to ease transition costs for fishermen, such as
buying back excess gear that current practices and market conditions
encouraged them to buy.

Habitat preservation demands cooperation, not conflict: a creative
alignment of science and markets, to save both fish and fishermen.
It's a harmony that we must achieve.

Copyright 2006 Newsday Inc.

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From: Rachel's Precaution Reporter #41, Jun. 7, 2006
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OPPORTUNITY TO OFFER PRECAUTION WORKSHOP FOR SCIENTISTS

By Peter Montague

The Centers for Disease Control and Prevention in Atlanta will be
sponsoring the 2006 National Environmental Public Health Conference
December 4-6 in Atlanta with the theme, "Advancing Environmental
Public Health: Science, Practice, New Frontiers."

We have it on good authority that the organizers of the conference
would be receptive to a proposal for a workshop on the precautionary
principle. This is an opportunity to promote discussion of
precautionary perspectives within the National Center for
Environmental Health, the Agency for Toxic Substances and Disease
Registry, and their umbrella organization, the Centers for Disease
Control and Prevention.

The deadline for submitting proposals for workshops is August 1. A
form must be filled out and submitted via email to conference
organizer Dr. Stephen Margolis at smargolis@cdc.gov. The necessary
form can be found here.

Complete the form, save a copy, and submit it as an e-mail
attachment to smargolis@cdc.gov. The form is a Word document and the
shaded areas will expand to accept your responses.

If you have questions regarding your submission, please contact: Dr.
Stephen Margolis at smargolis@cdc.gov [Telephone: (404) 498-0193]

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Rachel's Precaution Reporter offers news, views and practical
examples of the Precautionary Principle, or Foresight Principle, in
action. The Precautionary Principle is a modern way of making
decisions, to minimize harm. Rachel's Precaution Reporter tries to
answer such questions as, Why do we need the precautionary
principle? Who is using precaution? Who is opposing precaution?

We often include attacks on the precautionary principle because we
believe it is essential for advocates of precaution to know what
their adversaries are saying, just as abolitionists in 1830 needed
to know the arguments used by slaveholders.

Rachel's Precaution Reporter is published as often as necessary to
provide readers with up-to-date coverage of the subject.

As you come across stories that illustrate the precautionary
principle -- or the need for the precautionary principle --
please Email them to us at rpr@rachel.org.

Editors:
Peter Montague - peter@rachel.org
Tim Montague - tim@rachel.org

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To start your own free Email subscription to Rachel's Precaution
Reporter
send a blank Email to one of these addresses:

Full HTML edition: join-rpr-html@gselist.org
Table of Contents edition: join-rpr-toc@gselist.org

In response, you will receive an Email asking you to confirm that
you want to subscribe.

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Environmental Research Foundation
P.O. Box 160, New Brunswick, N.J. 08903
rpr@rachel.org
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:::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::: Rachel's Precaution Reporter #41 "Foresight and Precaution, in the News and in the World" Wednesday, June 7, 2006..............Printer-friendly version www.rachel.org -- To make a secure donation, click here. ::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::

Table of Contents...

Can Genetically Modified Crops Be Contained? Many Say No.
Can genetically modified (GMO) crops coexist with normal crops
without causing genetic contamination? Many people now say No. The
biotech industry favors global contamination, and once contamination
occurs, it can't be reversed, so a precautionary approach is the only
hope for preserving the world's stock of non-GMO crop genes.
European Chemicals Policy Is Driving Innovation Worldwide
In Europe, the precautionary approach to toxic chemicals in
electronic devices is driving innovation worldwide. Instead of
"precautionary principle," you might call it the ingenuity principle.
Proposed Risk Assessment Guidelines Would Snarl Government
The White House has found a way to bring government regulation to a
crawl, and perhaps a halt: delay governmental action until a high
degree of scientific certainty has been achieved in the risk
assessments that accompany new regulations.
Kaiser Permanente Adopts Comprehensive Chemicals Policy
In 2005, Kaiser Permanente, the largest U.S. health maintenance
organization, with headquarters in Oakland, California, adopted the
precautionary principle to guide its purchase, use and disposal of
chemicals.
Editorial: We Need to Work Together to Conserve Fish
"As we attempt to preserve habitat, we should follow the
precautionary principle: Even if science has not yet determined every
last detail of how a habitat nurtures fish, if we have strong evidence
that it's essential, we must preserve it."
Opportunity to Offer Precaution Workshop for Scientists
The Centers for Disease Control and Prevention in Atlanta has
issued a "call for workshops" for its National Environmental Public
Health Conference, Dec. 4-6, 2006. We are told that workshops on the
precautionary principle would be welcome. Who will step up to the
plate?

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From: New York Times, Jun. 6, 2006
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QUESTIONS ON BIOTECH CROPS WITH NO CLEAR ANSWERS

By Elisabeth Rosenthal

AUBINS, Spain -- Enric Navarro was dumbfounded when the letter arrived
from the testing lab of the Spanish organic farmers association in
late February, telling him his organic crop actually contained 12
percent genetically modified corn.

For Mr. Navarro, finding plants modified by biotechnology was almost
as traumatic as finding nuclear waste would have been. For four years,
he had lovingly planted hundreds of varieties of trees, shrubs,
flowers and herbs to attract just the right mix of insects so he would
not need fertilizers or weed killers on his precious seven hectares
(17.3 acres).

"If I could not farm organic, I would not farm," said Mr. Navarro,
dressed in sweatpants and a stained T-shirt as he sipped coffee in his
shed. "I could not sleep at night if I sold that crop."

He decided to burn the corn still in the field, to rid his farm of
what he called a "contaminant." But he is still not certain how the
unwanted seed got onto his property. There is no way to claim
compensation for his economic losses. And he is not sure when it will
be safe to use the field for his form of organic farming.

As the European Union begins opening its doors wider to genetically
modified crops, Mr. Navarro's byzantine experience serves as a
cautionary tale about the uncertainties surrounding the lack of
policies to deal with the problems that will almost certainly arise.

"There is a lot that hasn't been worked out," said Julian Kinderlerer,
of the Institute of Biotechnical Law and Ethics at the University of
Sheffield in England, who has advised the European Union on the issue.

For eight years, Spain was the only country in the union to permit
commercial cultivation of genetically modified crops. But in the last
18 months, the European Commission has approved 11 genetically
modified seeds for planting in the union, and in 2005, France,
Germany, Portugal and the Czech Republic began planting small
commercial plots.

In the United States, the vast majority of large commercial farms
plant genetically modified crops, like corn or soy, and there is no
general effort to distinguish those from nonbiotech crops and foods in
farming or food processing.

But the cornerstone of the European Union's new open-door policy is
the political conviction that it is possible for genetically altered
crops and conventional crops to coexist separately within Europe with
proper safeguards, like keeping a distance between fields and imposing
a liability system for accidents.

Scientifically, there are strong disagreements about whether
"coexistence" is possible, at what cost and even how it should be
defined.

"Coexistence is feasible in the vast majority of places, so long as
farmers talk to each other and cooperate," said Simon Barber of
EuropaBio, an industry group in Brussels. He said that experiences
like Mr. Navarro's should be rare.

But many scientists, and not just those with green credentials, think
coexistence is not feasible in many European countries, where small,
closely spaced farms are the norm.

"My experts all agreed that coexistence often just doesn't work," said
Chantal Line Carpentier, an agricultural economist who led a panel of
experts that studied the issue under the North American Free Trade
Agreement.

The study was requested by Mexico in 2002, after genetically modified
corn was found in fields in Oaxaca, hundreds of miles from the United
States. Mexico feared that the heartier modified variants would edge
out its unique native strains.

That report, "Maize and Biodiversity," released in 2004 by the North
American Commission on Environmental Cooperation, concluded that the
genetically engineered corn might well have a long-term effect on
Mexico's ecology and biodiversity and that it should be better studied
and monitored.

The United States and Canada attacked its conclusions. But some
farmers said the report did not go far enough. "Saying that G.M. and
non-G.M. farming can coexist is nonsensical," said Julian Rose, an
organic farmer from England. "It's like saying that noise and silence
can coexist in a room."

The scientific disagreement over coexistence is also partly a question
of definition: the biotech industry and new regulations proposed by
the European Union would permit some degree of inadvertent
intermixing.

The biotech industry considers "coexistence" achieved if mixing is
below 0.9 percent and, under proposed regulations, foods in the
European Union could be labeled free of genetic modification if they
contained less than this amount.

Such labeling is not required in the United States, where the two
types of product are regarded as essentially equivalent.

"I think that it's great we are able to commingle all types of corn,"
said Michael J. Phillips, a vice president of the Biotechnology
Industry Organization in Washington. "That allows us to sell it at low
cost and feed the world."

The concept of coexistence is problematic because there are simply too
many ways that mixing occurs, experts said. Wind blows seeds, mills
grind crops from different farms, a cookie contains oil made from
imported genetically modified soy. The genetically engineered corn in
Oaxaca was probably the progeny of corn ears that had been legally
imported for animal feed but whose kernels had been illegally used for
planting.

With so many routes, environmental groups say, the 0.9 percent limit
will inevitably be breached.

Mr. Phillips acknowledged that keeping modified and nonmodified crops
apart in fields or in the market was expensive and he ruled out
industry compensation. "If you're a small farmer trying to
differentiate your product," he said, "the onus is on you to pay for
the needed separation."

Last year, Greenpeace tested 40 organic farms in Catalonia. Nearly 20
percent had contamination, from 0.7 percent to 12 percent.

Spain decided to admit cultivation of genetically modified crops in
1998. Twelve percent of corn is now biotech -- about half of it in
Catalonia.

Mr. Navarro's two fields are 70 and 100 meters from neighbors' farms,
a distance often deemed adequate to prevent mixing. But it was windy
last winter, and perhaps some seed blew in, he speculated.

There is no log of who plants genetically modified seeds and nowhere
to turn for compensation for his economic losses. Neither the
Agriculture Ministry nor the organic farmers association could provide
guidance on how to clean up a contaminated field.

Mr. Navarro recently prepared a field in the center of his property
for planting corn, hoping that distance and the rows of shrubs will
protect it. If not, he says, he will quit.

Copyright 2006 The New York Times Company

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From: Boston Globe, Jun. 1, 2006
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TECH FIRMS FACE EU TOXICS TEST

Limits on the use of hazardous materials pushes US electronic makers
to innovate


By Hiawatha Bray, Globe Staff

A tough European Union law that limits toxic substances in electronic
devices takes effect on July 1, and US companies that want to do
business across the Atlantic are racing to comply, spending billions
of dollars to redesign their products.

"This is probably the biggest change in electronics in 50 years,"
said George Wilkish, senior quality engineer at M/A-Com Inc., a
business unit of Tyco Electronics Corp ., in Lowell that makes a
variety of radio and microwave components for communications gear.

Many electronic devices, like computer circuit boards and cathode ray
tubes, are crammed with substances that can cause serious health
problems if ingested. Lead can cause brain damage and pregnancy
complications, for example, and cadmium can cause kidney disease. To
prevent these poisons from ending up in landfills, EU regulators took
a two-tiered approach. A law that took effect last year requires
electronics firms to recycle their products, and the EU also enacted
RoHS -- the Restriction of Hazardous Substances Directive-- to
eliminate lead, cadmium, mercury, and three other toxic chemicals from
electronic devices.

The federal government sets no limits on the chemicals used in
electronics, but the power of RoHS extends far beyond Europe.

US companies must comply to retain their European customers. And after
spending millions to eliminate the substances, companies like M/A-Com,
which makes about 20 percent of its sales in Europe , plan to sell
their cleaner products not just to European clients, but also to
customers in the rest of the world.

Dick Anderson, senior principal engineer at M/A-Com's research and
development group, said the approximately $1 million cost of complying
with the European law will be good for business.

"In addition to doing this because it's the law, we're doing it
because it differentiates us," Anderson said. He figures that even US
customers will choose M/A-Com's components over those made by rivals
who haven't been as quick to clean up.

Other Massachusetts technology firms don't think they'll profit from
obeying the European standard because they expect their competitors to
comply as well. "There's no economic benefit we can derive from
this," said Denny Lane, director of product management at Stratus
Technologies Inc. of Maynard, a maker of computers and data storage
systems. "We can't say, 'We're green and you're not.' "

Still, Lane, who holds a degree in environmental biology, favors the
EU standards, even though compliance has cost his company "hundreds
of thousands" of dollars. "This is important," said Lane, "maybe not
for my kids, but my kids' kids."

America's biggest consumer electronics firms are also committed to
compliance. Leading desktop computer maker Dell Inc. says its product
line is almost all Euro-ready. Apple Computer Inc. said that its iPod
Nano and Shuffle music players meet the European standard and that all
Apple products will comply with the EU regulations by July 1.

Many businesses won't reveal exactly how much they've spent on RoHS
compliance. But Pamela Gordon, president of Technology Forecasters
Inc., a consulting firm in Alameda, Calif., estimates that US
electronics firms will spend a total of $3.5 billion.

Kenneth Stanvick, senior vice president and co-founder of Design Chain
Associates LLC in Pelham, N.H., said that some smaller electronics
firms haven't complied with the EU regulations, and hope to slip past
European regulators undetected. "It's risk management," he said.
"What are my chances of getting caught?"

But the odds against scofflaws will only get worse. China plans to
enforce an even stricter law beginning next March; South Korea will
set similar standards starting next July. And California has enacted
its own standards, which take effect in January.

Attempts to evade government regulations are a waste of time, said
Gordon of Technology Forecasters, "The astute electronics industry
executive realizes that environmental requirements are here," Gordon
said. "They're not going anywhere--they're going global."

Compliance with the new EU rule has not been easy. Boston modem maker
Zoom Technologies Inc. had to cancel a new product planned for the
European market because it couldn't be made in compliance with the
law.

"It turns out there's this one chip that we can't get," said Zoom
president Frank Manning . The only available version of the vital chip
contained toxic chemicals, and Zoom's order wouldn't have been large
enough for its maker to justify making a clean version.

A half-century ago, new soldering techniques enabled the mass
production of today's cheap electronic equipment. Today, the challenge
is to keep producing a vast array of electronic devices without
depending on lead solder. The alternatives, mostly based on tin,
require far hotter temperatures, which in turn can cause circuit
boards and other components to melt or crack. Switching to tin solder
not only requires new soldering gear, but also product redesigns, and
exhaustive testing of the finished components. At M/A-Com, engineers
test the lead-free components under vibration and extreme heat and
cold , then study the results under microscopes, in search of fatal
defects just a few microns in size.

Even so, tin solder still isn't as reliable as lead. So lead solder is
still permitted in devices with military and aerospace applications,
and in heavy-duty computer servers made by companies such as Stratus.
Even these exceptions will be reviewed every four years -- and
eliminated when European authorities judge that lead-free solders have
become more reliable.

Hiawatha Bray can be reached at bray@globe.com.

Copyright Copyright 2006 The New York Times Company

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From: Chemical & Engineering News (pg. 45), Jun. 5, 2006
[Printer-friendly version]

GUIDELINES FOR ASSESSING RISK

White House proposal could impede broad range of government
activities, agency representatives warn


By Cheryl Hogue

A White House plan for standardizing risk assessments across the U.S.
government is well-intended, representatives of federal agencies told
a National Research Council (NRC) committee late last month. But as
laid out in January by the President's Office of Management & Budget
(OMB)
, the proposal is likely to snarl government action, they
warned, giving plenty of examples.

Adherence to the proposed guidelines, they said, could deter the Food
& Drug Administration from telling the public about serious health
effects from a prescription drug. Or impede the National Institutes of
Health from providing guidance to health professionals about handling
blood from patients with HIV. Or slow down the Department of
Agriculture's assessments of whether a low-income pregnant woman,
infant, or young child is at risk of insufficient nutrition and thus
qualifies for supplemental foods provided by the government. Or hamper
the Occupational Safety & Health Administration's ability to issue
informational bulletins about potential workplace hazards. Or cause
the National Aeronautics & Space Administration to ditch years of work
compiling detailed risk assessment procedures that are highly specific
to space missions.

OMB's draft bulletin is designed to set minimum standards for the
scientific quality of federal agency assessments of risk to human
health, safety, or the environment. The guidance would require
agencies to describe the methods, assumptions, and uncertainties in
calculating a risk assessment and to provide a range of risk
estimates. It would apply to risk assessments performed for regulation
of pollutants, approval of new pharmaceuticals, and development of
safety systems for nuclear and chemical plants, liquefied natural gas
terminals, and space shuttles (C&EN, Jan. 16, page 6).

OMB asked NRC to review the proposal and to make suggestions for
improving it. The NRC committee reviewing the plan held its first
public meeting on May 22 to gather information. Members of the panel
got an earful from agency officials as well as from representatives of
academia, industry, and public interest groups.

John D. Graham, credited as the chief architect of the risk assessment
proposal, said the guidelines would apply to risk assessments done for
regulation, such as Environmental Protection Agency controls on
chemicals. They would also cover deregulation, such as the U.S.
decision to accept shipments of Canadian beef again after Canada put
systems in place to prevent mad cow disease, he said. The bulletin is
an internal guidance document that sets out OMB's expectations of how
agencies are to operate, he said.

Graham, who was the administrator of OMB's Office of Information &
Regulatory Affairs (OIRA)
from 2001 until earlier this year, is now
dean of the RAND Graduate School in Santa Monica, Calif.

Representatives from federal agencies said they supported the broad
goals of the bulletin, but most also laid out specific concerns about
how the proposal could inhibit key activities.

Steven K. Galson, director of FDA's Center for Drug Evaluation &
Research
, said OMB's bulletin would enhance the quality of his
agency's risk assessments. But it also may deter the agency from
activities that are important for protecting public health, he said.

For instance, the proposal's definition of risk assessment is too
broad, capturing activities that are not intended as formal risk
assessments, Galson said.

This broad definition could have serious impacts on FDA's getting
critical information to physicians and patients quickly about drugs,
medical devices, or foods, Galson said. He pointed out that this kind
of risk information is used not by federal regulators but by doctors
and patients to select the best course of action for patients.

For instance, FDA may, in the interest of protecting public health,
wish to inform the public about an adverse effect from a drug before
the agency can, through a formal risk assessment, define the
relationship between dose and outcomes, he said. Such a situation
occurred in June 2005 when FDA alerted the public about potential
suicidal thoughts and behavior in adults being treated with
antidepressant medications. The agency did so before it had completed
a formal review of the issue, which is still in process.

In addition, the agency is concerned that the OMB bulletin could
hamper FDA response to diseases that require rapid action, such as a
pandemic flu, Galson said.

The bulletin needs to distinguish "discovery research," such as
studies conducted by NIH, from risk assessments prepared by regulatory
agencies, said Christopher J. Portier, associate director for risk
assessment at the National Institute of Environmental Health
Sciences
. Because they identify hazards associated with chemicals,
human health studies and toxicology tests may eventually feed into
risk assessments conducted by regulatory agencies, he pointed out. But
the studies themselves, as well as National Toxicology Program
products, such as the congressionally mandated report on carcinogens,
need to be explicitly excluded from the bulletin's sweep, he said.

Meanwhile, many of the risk assessments done by USDA affect regulatory
actions pertaining to pests, diseases, safety of meat and poultry, and
release of genetically engineered organisms and would fall under the
proposed guidelines, said Linda Abbott, USDA senior scientist for risk
modeling. The department, however, is most concerned about whether the
OMB bulletin would apply to evaluations of people who may be eligible
for benefits under WIC, the Special Supplemental Nutrition Program for
Women, Infants & Children.

The proposal could also apply to assessments done to determine the
risks of individual farmer's fields to erosion and for other
environmental impacts. If the planned standards cover assessments of
such individual needs, some activities of the department could face
serious delays, she told the NRC committee.

Similarly, OSHA uses risk assessments almost exclusively for its
regulatory actions, said William Perry, acting deputy director of the
agency's standards and guidance directorate. The bulletin would apply
to those risk assessments. However, OSHA is unsure whether the
guidelines would also affect the nonregulatory, informational
bulletins that it issues occasionally about workplace hazards, Perry
said. For instance, OSHA and EPA in 2000 jointly issued an
informational bulletin warning about a little-known risk from molten
2,4-dichlorophenol (C&EN, May 1, 2000, page 49).

EPA is the agency rumored to be the main target of the OMB bulletin.
George M. Gray, the agency's science adviser, said, though, that EPA
"is in pretty good shape" for complying with the planned risk
assessment guidelines. The proposal, however, does not address how
interagency disputes over risk assessments will be resolved, Gray told
the NRC committee.

EPA has found itself at odds with other agencies in some of its
chemical-specific assessments. Notably, the agency's preliminary
drinking water standard for perchlorate came under heavy fire from the
Pentagon, the Department of Energy (DOE), NASA, and their contractors,
all of which face liability for pollution from this component of
rocket fuel and wanted a more relaxed standard. Eventually, NRC got
involved in the dispute and offered a safe daily dose number that was
higher than EPA's but would translate into a lower drinking water
standard for perchlorate than suggested by the military (C&EN, Jan.
17, 2005, page 13
).

Gray and Homayoon Dezfuli, manager for system safety at NASA's Office
of Safety & Mission Assurance
, pointed out that their agencies have
developed their own policies and procedures for risk assessments.
OMB's draft bulletin is silent on the role of these agency-specific
guidelines.

Dezfuli added that some of the proposal's standards are of limited
applicability to the agency's risk assessments or are inconsistent
with NASA's formal risk assessment procedures, which represent years
of effort. Harmonizing NASA's procedures to the ones proposed by OMB
would be a difficult task, he added.

In contrast with many agencies' worries about OMB's bulletin, Shannon
E. Cunniff, director of emerging contaminants at the Department of
Defense (DOD), indicated no concerns about the proposed standards to
the NRC panel.

The plan would apply to many of the military's risk assessments, she
said. Most focus on occupational issues, ranging from explosive safety
to the air quality inside submarines, but DOD also does site-specific
assessments of the risks from contaminants at its facilities, Cunniff
said. She added that the military is still trying to determine whether
the bulletin would be applicable to weapons safety.

Al Cobb, senior policy adviser in DOE's Office of Policy &
International Affairs, said his department probably has "the least
interest" in the bulletin among federal agencies because it has
virtually no regulatory role. However, DOE is interested in seeing
consistency among risk assessments in the government, he said.

John F. Ahearne, chair of the NRC committee, suggested that the
bulletin may affect DOE risk assessments done in connection with the
cleanup of sites such as the Hanford Nuclear Reservation in
Washington. Ahearne is director of the ethics program at Sigma Xi, the
scientific research society.

Meanwhile, it is unclear how OMB would ensure that agencies comply
with its risk assessment guidelines. The committee asked Nancy Beck, a
toxicologist and risk assessor at OIRA, about the consequences for an
agency that does not follow the guidelines. She responded, "We haven't
gotten that far."

Graham, the former OIRA chief, told the panel that OMB is "not
toothless" in ensuring that agencies follow its bulletins because OMB
determines agencies' annual budgets.

The committee also heard critiques of the proposal from those outside
the government. The draft bulletin uses a definition of risk
assessment that is broader than the standard one, which is "the
probability as well as the severity of risk," said Gilbert S. Omenn,
professor of medicine, genetics, and public health at the University
of Michigan Medical School. He chaired a congressionally mandated
commission that produced a 1997 report delineating the appropriate
uses of risk assessment and risk management in federal regulation.

"OMB has tried to put too much in there," agreed Alan J. Krupnick, a
senior fellow at Resources for the Future. He and Omenn, however,
endorsed the draft bulletin's intent of improving risk assessment
throughout the government.

Risk assessment, Omenn said, is distinct from the identification of
hazard presented by a commercial chemical, drug, or other agent, Thus,
he said, risk assessment does not include identification of hazards,
toxicology studies, structure-activity relationships, modeling, or
epidemiology studies. All of these, he said, are "preliminary" to risk
assessment. Omenn urged that the final version of the bulletin clearly
state that research on hazards does not fall under the proposed
guidance.

The NRC committee also heard a variety of arguments about one
particular provision in the draft guidelines. This part would require
federal risk assessments to provide a range of risk estimates, from
what some describe as the "worst case" to the "best case."

Cunniff endorsed ranges instead of a "point estimate," a single number
in an assessment reflecting the best judgment on what the risk is most
likely to be. Although risk managers tend to prefer a single point
estimate, this provides "a false sense of precision that can be
misleading to the public," she said.

But point estimates are appropriate because they are provided through
the expert judgment of risk assessors, said Robert Shull, director of
regulatory policy at watchdog group OMB Watch. Providing "mushy
ranges when point estimates are needed" inappropriately hands over
part of the risk assessor's job to policymakers deciding how to manage
risk, he said.

Judith A. Graham, managing director of the American Chemistry
Council's
long-range research initiative team, said ranges of risk
can be useful to risk managers. "I don't see how information is bad as
long as it doesn't cause paralysis by analysis," she said.

Jennifer Sass, a senior scientist at the Natural Resources Defense
Council
, said scientists within agencies often have expertise
specific to a narrow subject or location. The bulletin, by setting
government-wide standards, would strip these scientists of their
ability to provide expert judgments to agency decisionmakers, she
said. Shull agreed, saying the proposal would shift such judgments
from agencies to OMB.

The bulletin puts the onus on agencies to justify the risk assessments
underlying their regulatory decisions. Omenn and Sass pointed out,
however, that it explicitly excludes analyses by companies seeking
licenses, approvals, permits, and registrations from the federal
government. "I think that might be revisited," Omenn said.

ACC's Graham argued that the proposed standards should cover risk
assessments for agencies' overall policies for licensing, permitting,
or other approval, but not for those affecting decisions on companies'
products.

Lorenz Rhomberg, a principal at Gradient Corp., an environmental
consulting company, expressed concern about the proposal's broad call
for agencies to describe uncertainties in risk assessments. It is
difficult to deal with uncertainty comprehensively, he said, because
"someone can always think up" another factor that the assessment has
not addressed. Also, no scientific standards exist for analysis of
uncertainty. Rhomberg added that simply laying out uncertainties
without suggesting which are the most important is not helpful to
decisionmakers.

Sass noted that although the bulletin contains some positive aspects,
it lays out a burdensome approach that will hamper agencies from
taking regulatory action.

ACC's Graham, in contrast, had only praise for the bulletin. "The
bulletin is essential," she said, adding that it "will invigorate the
scientific community that has advanced the knowledge of chemicals and
ways to assess them only to be frustrated when that knowledge and more
sophisticated practice was not used" by agencies.

John D. Graham, the former OMB official, said the draft risk
assessment bulletin is likely to be revised in light of the NRC
committee's comments. Those are expected later this year.

Copyright 2006 American Chemical Society

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From: Kaiser Permanente, Mar. 23, 2005
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KAISER PERMANENTE ADOPTS COMPREHENSIVE CHEMICALS POLICY

Vision:

Kaiser Permanente aspires to create an environment for its workers,
members and visitors that is free from the hazards posed by chemicals
that are harmful to humans, animals and the environment.

Alignment with KP Values:

Linkages to Kaiser Permanente's Mission

KP's mission is to provide affordable, high-quality health care
services to improve the health of our members and the communities we
serve. Our concern for the health of our communities extends to the
air we breathe and the water we drink. (KP 2002-03 Annual Report)

KP's Environmental Stewardship Vision

We aspire to provide health care services in a manner that protects
and enhances the environment and health of communities now and for
future generations.

Alignment with Externally-Developed Environmental Concepts:

The Precautionary Principle

When an activity raises threats of harm to the environment or human
health, precautionary measures should be taken even if some cause and
effect relationships are not fully established scientifically. (From
definition created at the Wingspread Conference on the Precautionary
Principle, January, 1998.)

Extended Producer Responsibility (EPR)

EPR is an environmental policy approach in which a producer's
responsibility, physical and/or financial, for a product is extended
to the post-consumer stage of a product's life cycle. Manufacturers
should have a responsibility for the health impacts of the chemicals
they use and the products they create. Purchasers of these products
and chemicals have the right to request safety testing and full
disclosure of the results. Two key features are: (1) the shifting of
responsibility (physically and/or economically, fully or partially)
upstream to the producer and away from municipalities and purchasers,
and (2) to provide incentives to producers to take environmental
considerations into the design of the product. (The Organization for
Economic Co-operation and Development, 1994 Guidance Manual)

Issues:

1. In the U.S. we are experiencing alarming increases in chronic
diseases. Cancer, asthma, birth defects, developmental disabilities,
autism, endometriosis, and infertility are becoming increasingly
common. Mounting evidence links incidence and severity of these
diseases to environmental toxicants.

2. Lack of information from manufacturers of products used in health
care about all chemicals, ingredients, and processes used in
manufacturing.

3. Lack of safety testing to identify health and environmental impacts
for the majority of industrial chemicals.

4. Burdens faced by users (KP) due to the lack of information:

** ascertaining potential health impacts of products

** conducting assessments of products (resources, expertise, data)

** public concern

** research work and testing required of purchasers that want to
ensure products and chemicals are safe

** making product selection decisions without adequate information

** continued use of potentially hazardous materials

** potential liability

** unpredictable regulatory climate

** costs to organizations due to above listed burdens

5. Underclassification or mischaracterization of hazardous compounds.

Actions:

We will take the following actions to achieve our vision:

Internal focus

** Identify high priority chemicals and chemical groups; regularly
update and prioritize this data resulting in a living list of
chemicals of concern

** Conduct an inventory of product standards for presence of chemicals
of concern

** Understand cost implications of substitutions and incorporate cost
of ownership model into purchasing systems

** Communicate preferences to GPO, vendors and manufacturers

** When appropriate, communicate desired alternatives and reasons to
employees, members and the communities we serve

** Continue to pursue green building activities

** Develop goals and metrics to measure progress and include
mechanisms for sharing successes and lessons with the public

Contracting focus

** Create appropriate contractual obligations with manufacturers,
suppliers and distributors to:

** avoid identified chemicals of concern

** conduct and share results of extended toxicity testing

** disclose processes that use chemicals of concern even if the
chemicals used in the processes are not a part of the end product

** Substitute safer alternatives identified through hazard analysis

** Integrate a cost-of-ownership approach to assessing alternative
products

External focus

** Support sound public policies that promote greater evaluation of
chemicals and public disclosure

** Influence manufacturers to provide materials disclosure and
performance of safety tests

** Promote labeling of products with all ingredients

** Influence medical research into less hazardous clinical and
laboratory products and processes

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From: New York Newsday, Jun. 6, 2006
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EDITORIAL: WE NEED TO WORK TOGETHER TO CONSERVE FISH

On the way from the deep to our plates, the life journey of fish
depends heavily on preservation of the habitat that produces them. So
the struggle over habitat is vital to the well-being of our seas and
the survival of the fishing industry.

That fight takes many forms.

The Sustainable Fisheries Act of 1996, which updated the 1976
Magnuson-Stevens Act, ordered the regional fishery management councils
to designate and protect essential fish habitat for federally managed
fish species. That gives councils a powerful tool for commenting on -
and even influencing -- actions by other agencies that might harm
habitat. But it's a tool not always used. So environmental groups have
more than once sued the federal fishery bureaucracy for failing to
consider habitat sufficiently.

One suit involved tilefish, a major species for Montauk. In crafting a
management plan, the Mid-Atlantic Fishery Management Council did
examine whether some fishermen, using trawling gear to chase other
fish, are hurting tilefish burrows. The council found insufficient
evidence of damage to burrows. So the Natural Resources Defense
Council sued in 2001, arguing that the analysis was defective, and the
government should have protected the habitat. The NRDC lost, but there
will be other suits, here and elsewhere.

Another habitat protection strategy, not yet widely enough used, is
the designation of marine protected areas, where fishermen either
can't fish at all or can't use gear that would damage habitat. One
ardent advocate of this is right here on Long Island: David Conover,
the dean of the Marine Sciences Research Center at Stony Brook
University.

When commercial fishermen hear "essential fish habitat," they fear
closure of areas where they've fished for years. When recreational
fishermen hear "marine protected area," that sounds to them like
closure too. So some recreational fishermen have been pushing for
"freedom to fish" legislation, to block the designation of protected
areas. So far, it hasn't made much headway. Nor should it.

After all, marine protected areas are not exactly new. Rod Fujita, an
Environmental Defense expert on this, points out that, for centuries,
Pacific Islanders took that holistic approach, to conserve the
precious resource that kept them alive. There's no reason it can't
work now. In fact, in the North Pacific region, 380,000 square
nautical miles of ocean, the size of New England, are already
protected from bottom trawling.

Habitat issues are not easy. For example, it seems like just common
sense to say that we should protect coral formations, the nurseries
for many species, from trawling gear damage. Fishermen argue that no
sane fisherman would hurt coral -- but some fishermen must be doing
it.
The advocacy organization Oceana has strong before-and-after
photographic evidence.

As we attempt to preserve habitat, we should follow the precautionary
principle: Even if science has not yet determined every last detail of
how a habitat nurtures fish, if we have strong evidence that it's
essential, we must preserve it.

In addition to conserving fish, we must protect fishing communities.
So, if habitat preservation requires a reduction of trawling, policy
makers must find ways to ease transition costs for fishermen, such as
buying back excess gear that current practices and market conditions
encouraged them to buy.

Habitat preservation demands cooperation, not conflict: a creative
alignment of science and markets, to save both fish and fishermen.
It's a harmony that we must achieve.

Copyright 2006 Newsday Inc.

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From: Rachel's Precaution Reporter #41, Jun. 7, 2006
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OPPORTUNITY TO OFFER PRECAUTION WORKSHOP FOR SCIENTISTS

By Peter Montague

The Centers for Disease Control and Prevention in Atlanta will be
sponsoring the 2006 National Environmental Public Health Conference
December 4-6 in Atlanta with the theme, "Advancing Environmental
Public Health: Science, Practice, New Frontiers."

We have it on good authority that the organizers of the conference
would be receptive to a proposal for a workshop on the precautionary
principle. This is an opportunity to promote discussion of
precautionary perspectives within the National Center for
Environmental Health, the Agency for Toxic Substances and Disease
Registry, and their umbrella organization, the Centers for Disease
Control and Prevention.

The deadline for submitting proposals for workshops is August 1. A
form must be filled out and submitted via email to conference
organizer Dr. Stephen Margolis at smargolis@cdc.gov. The necessary
form can be found here.

Complete the form, save a copy, and submit it as an e-mail
attachment to smargolis@cdc.gov. The form is a Word document and the
shaded areas will expand to accept your responses.

If you have questions regarding your submission, please contact: Dr.
Stephen Margolis at smargolis@cdc.gov [Telephone: (404) 498-0193]

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Rachel's Precaution Reporter offers news, views and practical
examples of the Precautionary Principle, or Foresight Principle, in
action. The Precautionary Principle is a modern way of making
decisions, to minimize harm. Rachel's Precaution Reporter tries to
answer such questions as, Why do we need the precautionary
principle? Who is using precaution? Who is opposing precaution?

We often include attacks on the precautionary principle because we
believe it is essential for advocates of precaution to know what
their adversaries are saying, just as abolitionists in 1830 needed
to know the arguments used by slaveholders.

Rachel's Precaution Reporter is published as often as necessary to
provide readers with up-to-date coverage of the subject.

As you come across stories that illustrate the precautionary
principle -- or the need for the precautionary principle --
please Email them to us at rpr@rachel.org.

Editors:
Peter Montague - peter@rachel.org
Tim Montague - tim@rachel.org

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To start your own free Email subscription to Rachel's Precaution
Reporter
send a blank Email to one of these addresses:

Full HTML edition: join-rpr-html@gselist.org
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In response, you will receive an Email asking you to confirm that
you want to subscribe.

::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::: Environmental Research Foundation
P.O. Box 160, New Brunswick, N.J. 08903
rpr@rachel.org
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