Saving us from ourselves

If the average American knew just how unregulated the chemical industry is in this country, there would be an epidemic of people crawling under the bed with an organic cotton blankie and refusing to come out.

It really is insane the way our country sacrifices common sense and consumer safety on the alter of the free market, and goes about regulation exactly backwards.

Since the passage of the benign-sounding Toxic Substances Control Act of 1976, banning and/or restricting chemicals is extremely difficult. That law, the nations chemical policy, grandfathered in about 62,000 chemicals and compounds that were in commercial use at that time. Chemicals developed after the law went into effect did not have to undergo safety testing. Instead of oversight, chemical companies were trusted with the task of self regulating. They were asked - but not mandated - to report toxicity information to the government, and the government would decide if further testing would be necessary.

In the 32 years since Gerald Ford signed the bill into law, the EPA has required additional studies for a mere 200 chemical compounds that are components of consumer products - a tiny fraction of the 80,000 chemicals in use in this country, and the government has had little or no information on most of those chemicals.

Only five chemicals have been banned since the TSCA became law.

The barriers to regulating the chemical industry are so high that the EPA has been unable to ban asbestos, even though we know that asbestos is a carcinogen, and has been banned in more than 30 countries. Instead of regulating, the EPA is hogtied, forced to rely on the chemical industry to voluntarily stop producing and using suspect chemicals.

If you think that the chemicals you buy to unclog your drain, scrub your tub, clean your counters, etc have been tested for safety, you are mistaken.

In this country, regulation happens after the fact.

I told you it's nuts the way safety has been suborned to capitalism. Do you believe me yet?


Ironically, capitalism and the global economy is forcing companies in this country to change their ways if they want to have access to the 500 million strong consumer market in the European Union.

This month the EU rolled out the first of stringent new restrictions on chemicals that are linked to health problems. These changes are forcing U.S. industries to find new ways to produce a wide range of everyday products if they want to continue to access EU markets. The new regulations require that companies to show that a chemical is safe before it can be used in commercial products.

Manufacturers are grumbling, complaining that compliance with the EU laws will add billions to their costs and increasing the price of some products. The Europeans calmly maintain that there is no need to comply - unless they want to continue to sell their products in EU markets.

"There's a strong sense in Europe and the world at large that America is letting the market have a free ride," said Sheila Jasanoff, professor of science and technology studies at Harvard University's John F. Kennedy School of Government. "The Europeans believe . . . that being a good global citizen in an era of sustainability means you don't just charge ahead and destroy the planet without concern for what you're doing."

Under the E.U. laws, manufacturers must study and report the risks posed by specific chemicals. Through the Internet, the data will be available for the first time to consumers, regulators and potential litigants around the world. Until now, much of that information either did not exist or was closely held by companies.

"This is going to compel companies to be more responsible for their products than they have ever been," said Daryl Ditz, senior policy adviser at the Center for International Environmental Law. "They'll have to know more about the chemicals they make, what their products are and where they go."

The new European laws have been several years in the making, and the bu$h administration and American chemical companies have fought against them every step of the way.

Four U.S. agencies -- the EPA, the Commerce Department, the State Department and the Office of the Trade Representative -- argued that the system would burden manufacturers and offer little public benefit.

In 2002, then-Secretary of State Colin L. Powell directed the staffs of American Embassies in Europe to oppose the measure. He cited talking points developed in consultation with the American Chemistry Council, a manufacturers trade group.

Mike Walls, the chemistry council's managing director of government and regulatory affairs, said that 90 percent of its members are affected by the E.U. laws and that some cannot afford the cost of compliance. "We're talking about over 850 pages of regulation," he said.

The E.U. standards will force many manufacturers to reformulate their products for sale there as well as in the United States. "We're not looking at this as a European program -- we're buying and selling all over the globe," said Linda Fisher, vice president and chief sustainability officer for DuPont and a former EPA deputy administrator.

DuPont alone is expecting to spend tens of millions of dollars to register chemicals they produce for sale in the EU member countries. They expect 20 to 30 of the substances they register to be on the EU "substances of very high concern" list.

One such chemical is perfluorooctanoic acid (PFOA), a substance used in the manufacture of teflon and many other consumer goods, including food packaging, carpeting and clothing, and electronic equipment. PFOA is a "suspected" carcinogen and builds up in human tissue and the environment. DuPont has already paid a $16.5 million dollar settlement to the EPA after the agency charged that the company had illegally withheld information about health risks posed by PFOA, and about water pollution near a West Virginia plant. Dupont and other companies have agreed to cease production of PFOA by 2015.

Toxic chemicals fall into three main categories - carcinogens, mutagens and endocrine disruptors. Carcinogens are chemicals that have been causally linked to increased rates of cancer. Mutagens alter the genetic information, usually the DNA, of organisms, increasing the incidence of mutations above the normal background levels of incidence. Mutagenic compounds are of particular concern to women of childbearing age. Endocrine disruptors are chemicals that mimic hormones and interfere with the normal operation of the endocrine system. The theory of endocrine disruption posits that toxicity can occur at much smaller levels of exposure than carcinogenic and mutagenic agents, because the endogenous hormones produced by the ductless glands of the endocrine system and secreted into the body are present in low concentrations, those of us who are proponents of endocrine disruption theory posit that exogenous disruptors can have an effect at lower concentrations than are necessary for carcinogenic or mutagenic effects to manifest. The mechanisms of endocrine disruption are being studied now, and previously unknown mechanisms are emerging. In December a study by researchers at UC Davis was released that revealed a previously unknown disruptor mechanism in antibacterial agents added to hand soap. Previous mechanisms have interfered with hormonal function by binding to receptors and blocking the hormones from attaching to the receptors and functioning properly. The researchers at UCD found that the chemical added to soaps amplified the effects of hormones and led to pronounced prostate growth in male rats.

We also point to increased rates of infertility, diabetes and other disorders of the endocrine system. The mechanisms of endocrine disruption are under study right now, and I am constantly on the lookout for new information that can either verify or disprove my loosely-help belief that the theory is probably correct. (No scientist worth his or her salt ever holds any theory other than gravity or evolution too tightly - as a freshman in college a crusty old chemistry teacher told me that the job of a scientist is to constantly try to prove yourself wrong. That bit of wisdom, the dipole moment, and electron spin are what I remember the most from the multiple classes I took from him.)

Since a fair chunk of my career was spent in endocrine research, and since most people are at least casually acquainted with carcinogens and mutagens, I want to concentrate on endocrine disruption. I have had questions for a long time that I can't answer - I am not on any of the research teams that might be looking for those answers, and even if I was, giving them would be so far above my pay-grade that I would never "go there" without the paper in hand, after it had been stringently peer reviewed by scientists whose work I know and trust.

It would be irresponsible of me to make any assertions, so I feel compelled to point out specifically that my questions are speculation only.

What I can do is tell you, the reader, what my questions are and give you a little bit of background to let you know why I ask them.

Since the TSCA became law, my generation, which was in adolescence at the time, has come of age and we are now middle aged, one generation has been born and raised to adulthood, and another is now entering young adulthood.

It is those young adults coming of age now that concern me the most. At the end of my 24 year career I routinely saw something that I had never seen - not once - in the entire first 15 years. Type II diabetes in kids. Part of it is diet and exercise - but we have always had chubby kids who didn't eat a proper diet or get enough exercise, but none of them were diagnosed with Type II diabetes, a disorder of the endocrine system. The lines have so blurred that we have renamed juvenile diabetes type I and adult-onset type II.

The question that I have is this: Is there something in the environment that we are using now that was not previously in use that is affecting the ability of insulin receptors to function properly?

Is there a connection between increased rates of infertility and everyday chemicals?

We know that a lot of things have changed over the last thirty years. For starters, meat is produced far different than it was back then. Thirty years ago, beef was for the most part grass-fed on family farms and ranches, and it took a steer 4 years to mature and go to market. No longer. Now, most meat comes from feedlots and CAFOs. Those industrially-raised animals are pumped full of growth hormones and antibiotics to cut the time it takes to bring a steer to market to about 14 months. Those growth hormones are residual in the meat at the supermarket, as well as in dairy products.

Food packaging has also undergone a revolution that is not for the better. When I was a kid, soda pop (which wasn't made from corn syrup back then) came in aluminum cans or glass bottles, not in plastic; and meat came in butcher paper, not polystyrene trays and plastic wrap, and plastics were not so prevalent in our everyday life. The dairy products we buy in boxes, like yogurt, cottage cheese and sour cream, used to be packaged in waxed cardboard, but now come in plastic tubs. Plastics, made from petroleum, have multiple toxicities identified.

So what can you do to protect yourself and your kids when your government cares more about the bottom lines of Vulcan and Dow and DuPont than they do the health and well-being of the citizenry they are sworn to protect by virtue of the jobs they hold, while we wait for responsible European laws to take effect and work their magic on the American marketplace?

Study, research and spend your money wisely. Of course buying organic when at all possible is a given - but look at the packaging of what you are buying, too. Throw open your cupboards and scrutinize the ingredients - then go to the internet and look up the MSDS (Material Safety Data Sheet) on the chemical ingredients listed on the products you use routinely. Be a responsible consumer and don't spend your hard-earned money on things that are likely to poison you.

And be prepared to save your own ass, because the government doesn't care about you., or me, or the man behind the tree - unless one of us is a captain of industry. I dunno about you, but the last thing I was a captain of was a pool league team.

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How the EPA found a way to fall on it's sword one more time in the waning days of Bu$hCo

In March of this year, the GAO warned that the EPA's IRIS (Integrated Risk Information System) database was at risk of becoming obsolete because the EPA is buried under pending assessments of threats posed by chemicals present in the environment. When I say it is buried, that is almost an understatement. In fiscal years 2006 and 2007, a total of four assessments were completed of thirty two submitted over the same period of time. Currently, over seventy assessments are pending. [The chart below, found on p.7 of the report illustrates the increase in the backlog and the decrease in completion of reporting.]



In response to the GAOs findings, in early April the EPA issued it's revised IRIS assessment process, supposedly aimed at streamlining the process and promoting transparency and increasing confidence in the credibility of assessments. Instead, the changes the EPA employed gave the White House the ability to further obstruct the process. Under the guise of "streamlining" another layer was added - bringing the Office of Management and Budget into the mix, and the OMB promptly started two investigations that are holding up the release of assessments.

Earlier this week, the GAO weighed in on the EPA's "efforts."

EPA’s new process expressly defines such comments as “deliberative” and excludes them from the public record. GAO continues to believe that it is critical that input from all parties—particularly agencies that may be affected by the outcome of IRIS assessments—be publicly available. In addition, the estimated time frames under the new process, especially for chemicals of key concern, will likely perpetuate the cycle of delays to which the majority of ongoing assessments have been subject. Instead of significantly streamlining the process, which GAO recommended, EPA has institutionalized a process that from the outset is estimated to take 6 to 8 years to complete. This is problematic because of the substantial rework such cases often require to take into account changing science and methodologies. Since EPA’s new process is not responsive to GAO’s recommendations, the viability of this critical database has been further jeopardized. [p.2]

Another change keeps comments from other federal agencies on assessments out of the public record.

It is important that the comments of other agencies be included in the public record because although IRIS assessments are not by nature regulatory, quantitative IRIS values are one of the data points considered when risk-management decisions are made and therefore they serve as a benchmark of regulatory consideration.

This process is obstructed by the fact that the completion process for assessments is so dismal. Because of the staggering backlog, the EPA has been unable to complete assessments of key chemicals that are in the forefront of public health concern for their known health risks, including carcinogenic and mutagenic properties. Chemicals awaiting formal assessment include known offenders like trichloroethylene (TCE), naphthalene, tetrachloroethylene, dioxin, and formaldehyde.

And just when you thought that the process was just about manipulated to the max - they manage to throw one more spanner in the works - unlike every other department in FDA and pretty much all departments across all agencies of the federal government - there is no timeline for completion of assessments.

IRIS was put in place in 1985 to increase constituent confidence in the agency and the governments ability to protect it's citizens, after high-profile chemical contamination cases led to the abandonment of first Love Canal, New York in 1981, and then Times Beach, Missouri in 1985. The database was conceived of as a sort of clearing house for information on toxic chemicals.

Its importance has increased over time as EPA program offices and the states have increasingly relied on IRIS information in making environmental protection decisions. Currently, the IRIS database contains assessments of more than 540 chemicals. According to EPA, national and international users access the IRIS database approximately 9 million times a year. EPA’s Assistant Administrator for the Office of Research and Development has described IRIS as the premier national and international source for qualitative and quantitative chemical risk information; other federal agencies have noted that IRIS data are widely accepted by all levels of government across the country for application of public health policy, providing benefits such as uniform, standardized methods for toxicology testing and risk assessment, as well as uniform toxicity values. Similarly, a private-sector risk assessment expert has stated that the IRIS database has become the most important source of regulatory toxicity values for use across EPA’s programs and is also widely used across state programs and internationally.

Historically and currently, the focus of IRIS toxicity assessments has been on the potential health effects of long-term (chronic) exposure to chemicals. According to OMB, EPA is the only federal agency that develops qualitative and quantitative assessments of both cancer and noncancer risks of exposure to chemicals, and EPA does so largely under the IRIS program. [p.3]

When the GAO revisited the system changes that the EPA announced in April, they discovered that the new tweaks were actually counterproductive. The new requirement that OMB review assessments contributes to the backlog - assessments completed by the EPA essentially stnd on line awaiting OMB approval before they are released. And every single delay presents the distinct possibility that the entire process will have to be started over again as methodologies and best practices advance.

Further, because EPA staff time continues to be dedicated to completing assessments in the backlog, EPA’s ability to both keep the more than 540 existing assessments up to date and initiate new assessments is limited. Importantly, EPA program offices and state and local entities have requested assessments of hundreds of chemicals not yet in IRIS, and EPA data as of 2003 indicated that the assessments of 287 chemicals in the database may be outdated—that is, new information could change the risk estimates currently in IRIS or enable EPA to develop additional risk estimates for chemicals in the database (for example, developing a cancer potency estimate for assessments with only noncancer estimates). In addition, because EPA’s 2003 data are now more than 4 years old, it is likely that more assessments may be outdated now.

The consequences of not having current, credible IRIS information can be significant. EPA’s inability to complete its assessment of formaldehyde, which the agency initiated in 1997 to update information already in IRIS on the chemical, has had a significant impact on EPA’s air toxics program. Although in 2003 and 2004, the National Cancer Institute and the National Institute of Occupational Safety and Health (NIOSH) had released updates to major epidemiological studies of industrial workers that showed a relationship between formaldehyde and certain cancers, including leukemia, EPA did not move forward to finalize an IRIS assessment incorporating these important data. Instead, EPA opted to await the results of another update to the National Cancer Institute study. While this additional research was originally estimated to take, at most, 18 months to complete, at the time of our report (more than 3 years later) the update was not complete. In the absence of this information, EPA’s Office of Air and Radiation decided to use risk information developed by an industry-funded organization—the CIIT Centers for Health Research—for a national emissions standard. This decision was a factor in EPA exempting certain facilities with formaldehyde emissions from the national emissions standard.[p.7-8]

Yes -you caught that right. Data from a study funded by the chemical industry was used to formulate the assessment of health risk for formaldehyde. The mind boggles...

Actually, what they have done by intent is what has occurred by accident and derailed a thousand promising research projects. I spent a big part of my career in research labs, and we have a name for the phenomenon they have employed by design. We call it "paralysis by analysis."

The EPA is yet another federal agency that has been crippled and undermined, kept from completing it's mission, and the detriment of the agency has served to the benefit a select few who have been allowed to operate under outdated assessments and continue polluting at unsafe rates.

The next president needs an EPA chief with a strong background in toxicology and environmental sciences. And the balls to stand up to gigantic, polluting corporations who perceive the best interest of human beings - especially poor and powerless ones - to be diametrically opposed to their own.

The next person to head up the EPA will be tackling a thankless job, and have to do battle every day - but battle he or she must, because the job they will be tasked with will have an impact on the quality of life and health of future generations for the foreseeable future.

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