Posted by: Lawyer Sanders | June 25, 2008

Pfizer settles Clean Air Act violations for release of hazardous air pollutants.

The pharmaceutical company Pfizer Inc. has agreed to pay a $975,000 civil penalty to resolve alleged violations of the Clean Air Act at its former manufacturing plant in Groton, Conn., the Justice Department and Environmental Protection Agency (EPA) announced on June 23rd.  The settlement is the first of its type in federal court under regulations that are designed to control the emissions of hazardous air pollutants from pharmaceutical manufacturing operations. 

The consent decree filed in U.S. District Court in Connecticut settles government claims that Pfizer violated the “National Emission Standards for Pharmaceuticals Production” and the “National Emission Standards for Organic Hazardous Air Pollutants for Equipment Leaks,” (PharmaMACT regulations) under the federal Clean Air Act.  The PharmaMACT regulations impose “Maximum Achievable Control Technology” (MACT) standards, which are industry-specific measures that must be implemented to control hazardous air pollutants in order to prevent harm to human health or the environment.  
     
The alleged violations, which occurred between October 2002 and December 2005, resulted from a failure of Pfizer’s leak detection and repair (LDAR) program at its former manufacturing plant in Groton.  Under the PharmaMACT regulations, the LDAR program set forth various equipment, testing and record-keeping requirements to ensure that any leaks of air pollutants from equipment used in the manufacture of pharmaceutical products are timely detected and repaired.  The specific violations, associated with the production of bulk pharmaceutical materials, included a failure to properly conduct pressure tests to identify leaks, repair leaks before start-up, equip open-ended lines with a cap or other seal, and document leak tests to establish full compliance with the LDAR requirements.

During its production of pharmaceutical-grade chemicals, Pfizer used substances such as methanol, hydrogen chloride, methylene chloride, MTBE, hexane, toluene, and many others, which are classified by EPA as hazardous air pollutants under Section 112 of the Clean Air Act.


Responses

  1. EPA, Chemical Manufacturers Assn, toluene, Public Health.
    My writing is on the very strong possibility, the US environmental protection agency may be influenced by outside forces that make it virtually impossible for it to be totally objective. This includes men in top positions with ties to the Chemical Manufacturers Association. The name is now American Chemistry Council. One of its subgroups is the American Solvent Council. The names and positions of these men are James Connaughton, chairman of the Council on Environmental Quality and Jeffry Holmstead EPA’s director of Air and Radiation. Both men are directly associated with the American Chemical Council, formerly the Chemical Manufacturers Assn. The official lobbying group for chemical companies.
    Several of his oncologists believe my husband’s myelofibrosis and possibly his acute myeloid leukemia subtype M7 was caused by a certain substance. This substance was toluene.. Jerry was in contact with this when he was employed in a dry cleaners for seven years. He worked with this chemical weekly. It is a solvent and a hydrocarbon. According to the Oxford American Dictionary toluene is a derivative of benzene.

    There are seven subtypes of acute myeloid leukemia. Suffice to say for the purpose of my article M7 is the type caused by scarring of the bone marrow, aka myelofibrosis. Myelofibrosis is considered by the medical profession as a myeloproliferative disease. The definition of myeloproliferative is as follows: Proliferation of cells in the bone marrow. These cells include white blood cells, red blood cells (corpuscles) and platelets. Myelo is the medical term for bone marrow.

    I noticed, within days, in my search for toluene as a carcinogen one glaring note. Most of the medical sites claimed the chemical did cause cancer. It was a factor in the blood cancers. The EPA a US govt. agency said it wasn’t carcinogenic. It did state it was a probable human carcinogen. However it stopped from stating it caused cancer. In other words it went, metaphorically speaking, getting engaged, planning the entire wedding and then getting cold feet and calling the marriage off.
    The chemical is known scientifically as methylbenzene. Benzene is dealkylation of toluene. Dealkylation is when are more than one alkyl group is substituted for atoms of hydrogen. The relationship to toluene is this. Toluene is an alkyl group bound to a benzene ring. I find it at the very
    least intriguing that benzene and toluene are so closely tied together. The two are definitely related. Please note benzene is definitely linked with causing leukemia. Its suspected to be a causative factor in Non Hodgkins Lymphoma, Multiple Myeloma and Acute Lymphatic Leukemia. These are cancers of components of the bone marrow. I can hardly believe its a mere coincidence toluene is so closely linked to benzene. Toluene is an analogous compound to benzene. In fact it is derived from Benzene. Hydrodealkylation turns toluene to benzene. Source. http://www.answers.com hydrodealkylation The link to toluene and cancer been known for 20years

    Toluene is used in the paint industry in paint thinners, Dry Cleaning companies, adhesive manufacturing, as a solvent in many industries, machinery manufacturing and repair, insecticides, pharmacueticals, printing, wood staining and varnishes. Source http://www.scorecard.org. Scorecard is an unbiased source on information on polluting chemicals.
    Medical sites such as http://www.medscape.com, webmd.com, emedicine.com claims it does cause leukemia. US Government sites for the most part says it doesn’t. I wonder if the fact that two of the officials of the EPA are with major connections of the Chemical Manufacturers Association. The Chemical Manufacturers Association are one of the biggest contributors to George W. Bush’s presidency. I don’t believe this is merely coincidence. The CMA defends some of the worst polluters in the US. Or if you’re Jungian, synchronicity either for that matter.

    Maybe this doesn’t exactly prove the EPA is being influenced by the CMA. However at the very least it certainly doesn’t look Kosher either. No govt. agency of what ever nation should be composed of people with any conflict of interest of what ever kind.

    Here are some links to medical sites I found by doing a search on toluene and cancer using http://www.medscape.com This is a health search engine used by health care professionals. Health consumers can use it too. It uses http://www.medscape.com, http://www.emedicine.com, http://www.medline.com. Everyone of them are professional medical resources.

    http://www.emedicine.com/med/TOPIC78.HTM This is on myelofibrosis. This is a condition that causes scarring of the bone marrow. It can be linked to acute myeloid leukemia. Its the subtype M7 type. http://www.emedicine.com/ped/TOPIC1301.HTM Topic AML.
    http://www.virtualcancercentre.com says certain organic chemicals such as benzene and toluene are linked to AML. Each of these links definitely state there is a direct link between toluene and acute myeloid leukemia and myelofibrosis. Each of these links are true medical sites.

    do know the CMA, in 1998, petitioned the EPA (environmental protection agency) to declare toluene as not being a volatile organic compound. This ruling still stands. The truth is it most certainly is. One way of knowing if any substance is volatile is to note an odor. Toluene definitely smells. Its the exact same substance used in glue, nail polish, nail polish remover. Each of these items exhibits a somewhat strong, sweet odor. In fact it was this aromatic quality that led to glue sniffing to get high. This glue contains toluene.

    Toluene definitely is odoriferous. Howeever its perfume next t when the EPA says something is non-carcinogenic when medical professionals claim it is. I wonder how many people’s health is severely damaged because of this discrepancy? Millions of females from lets say, twelve to whenever paint their nails, practically daily. How many are exposed to toluene. I would venture to say millions, if not tens of
    adparams.getadspec(’c_billboard1′); I discovered that the secretary of the interior under the George W. Bush administration had direct connections with the Chemical Nanufacturers Association. My suspicion is the CMA is influencing the EPA to the detriment of the health of the US population.

    Maybe I’m wrong. Yet when I see some of the top level people of the Bush presidency are connected with an organization with much to gain with lax environmental rulings I became rather suspicious. This is especially so when they just happen to be major contributors to G.W. Bush. I find it quite difficult believe its merely coincidental. On the contrary I think its no accident that the EPA isn’t as reliable , trustworthy as it should be.

    My husband may have been a victim of the CMA influence of the EPA. I wonder how many others were victimized too. Believing they were dealing with non carcinogens when in reality they were. I wonder too, how many other carcinogens or for that matter, chemicals US citizens are in the dark because of undue influence by professional groups with agendas influencing the EPA?
    One may say, well isn’t everything composed of chemicals. Yes, of course this is true. However these are firms that deal exclusively in the chemicals themselves. It certainly seems to me that any organization that holds an agenda that prevents any US government agency not totally objective should be disallowed to be an influence. This includes anybody with any connections with such organizations. The EPA and every other US govt. organization should not be tainted. People’s health and trust is at stake


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