Navigation Links
Pfizer to Pay $975,000 for Alleged Clean Air Violations at Connecticut Facility
Date:6/23/2008

WASHINGTON, June 23 /PRNewswire-USNewswire/ -- 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 today. Today's 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.

"This significant penalty, the first in federal court under the PharmaMACT regulations, should send a strong message to the pharmaceutical industry that they must be diligent in detecting and repairing leaks of hazardous substances" said Ronald J. Tenpas, Assistant Attorney General for the Justice Department's Environment and Natural Resources Division. "We will not wait to enforce the law until after a catastrophe occurs. Penalties such as this one compel the industry's close attention and rigorous implementation of the leak detection requirements to prevent the escape of harmful air pollutants that can endanger the public."

"All facilities that produce hazardous air pollutants must carefully adhere to all provisions of EPA's Clean Air requirements to ensure that we are taking every necessary step to protect human health and our environment," said Robert W. Varney, regional administrator of EPA's New England office.

Under the agreement, Pfizer certifies that the violations have been corrected. However, the violations undermined EPA's ability to determine compliance, which presented the risk of excess emissions of hazardous air pollutants for leaks that were not timely detected and repaired. The Groton facility itself ceased pharmaceutical manufacturing in January 2008.

Pfizer, a publicly traded corporation, incorporated in Delaware, operates about 80 manufacturing plants worldwide where it makes healthcare products relating to human and animal health.

A copy of the consent decree is available on the Justice Department Web site at http://www.usdoj.gov/enrd/Consent_Decrees.html.


'/>"/>
SOURCE U.S. Department of Justice
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Ranbaxy and Pfizer Settle Lipitor Litigation Worldwide
2. Novartis, Pfizer and Merck Take the Lead on Strong Relationships with Physicians, as Doctors Demand an Expanding Set of Services
3. Pfizers work on penicillin for World War II becomes a National Historic Chemical Landmark
4. AUDIO from Medialink and Pfizer: Free Programs for Uninsured Men and Women Who Need Help Paying for Medicine
5. AVANT Immunotherapeutics Announces Hart-Scott Rodino Clearance to License Cancer Vaccine to Pfizer
6. Simvastatin Leads Pfizers Lipitor in Second-Line Patient Share for the Treatment of Dyslipidemia
7. AUDIO from Medialink and Pfizer: Cover the Uninsured Week Focuses Attention on 47 Million Uninsured Americans
8. Pfizer Partners with REvolution Computing to Improve Medicine Production Pipeline
9. HealthFitness Teams with Pfizer Health Solutions to Implement CMS Senior Risk Reduction Demonstration Project
10. Astellas/GlaxoSmithKlines Vesicare Has Advantages Over Pfizers Detrol LA/Detrusitol XL in Reducing Episodes of Urge Urinary Incontinence
11. AUDIO from Medialink and Pfizer: Viagras 10th Anniversary
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/24/2017)... ... ... The California State University Institute for Palliative Care is pleased ... palliative care education and research. The Symposium, “Innovate. Investigate. Educate: Advancing Academic Palliative ... Sept. 28 and 29, 2017, on the campus of California State University San Marcos. ...
(Date:2/24/2017)... ... February 24, 2017 , ... The Radiology Business Management Association will ... at the annual Building Better Radiology Marketing Programs conference, held this year ... Worth, Texas. Nine awards are given out in five categories. They are:, ...
(Date:2/23/2017)... ... February 23, 2017 , ... Thinksport, ... with The Jensie Gran Fondo of Marin. For the second year in a ... broad-spectrum, mineral-based sunscreen. , “We are thrilled to provide our safe, non-toxic sunscreen ...
(Date:2/23/2017)... NJ (PRWEB) , ... February 23, 2017 , ... ... media outlet with a clinician-based audience, will be participating in Rare Disease Day ... in Washington, D.C. In addition, Rare Disease Report, a website, weekly e-newsletter and ...
(Date:2/23/2017)... ... February 23, 2017 , ... Rosica Communications, a national ... marketing, social media management, corporate communications, SEO and cause marketing, is opening an ... nearby New Hampshire, Massachusetts and Canada, Rosica will focus on expanding its footprint. ...
Breaking Medicine News(10 mins):
(Date:2/23/2017)... Research and Markets has announced the addition ... report to their offering. ... The latest research Fibromyalgia Drugs Price Analysis and ... global Fibromyalgia market. The research answers the following questions: ... Fibromyalgia and their clinical attributes? How are they positioned in the ...
(Date:2/23/2017)... Feb. 23, 2017 Regulus Therapeutics Inc ... and development of innovative medicines targeting microRNAs, today announced ... financial results on Thursday, March 2, 2017 after the ... call and webcast on March 2, 2017 at 5:00 ... year 2016 financial results and provide a general business ...
(Date:2/23/2017)... India , February 23, 2017 ... Imaging Market by Product (X-ray Imaging Digital, Analog), MRI ... Application (OB/GYN, MSK, Cardiology, Oncology), End User (Hospitals, Imaging ... the report studies the global market over the forecast ... to reach ~USD 36.43 Billion by 2021, at a ...
Breaking Medicine Technology: