Pharmaceutical Manufacturer fined $44,623 for Community Right-to-Know Violations
Release Date: 11/09/2011 – USEPA.gov
According to USEPA data, a pharmaceutical manufacturer, has agreed to pay a $44,623 civil penalty to settle four violations of environmental regulations related to the public reporting of toxic chemicals at its facility in Bridgeton, Mo. Submission of the annual toxic chemical reports is a requirement of the Emergency Planning and Community Right-to-Know Act (EPCRA). Under EPCRA regulations, companies of certain size are required to submit annual reports to EPA and state authorities listing the amounts of regulated chemicals that their facilities release into the environment through routine activities or as a result of accidents.
According to an administrative consent agreement filed by EPA, the Agency conducted an inspection the facility in December 2010. The inspection found that the company had failed to make a timely report to EPA and the State of Missouri on quantities of tetracycline hydrochloride that were manufactured, processed or otherwise used at the facility during 2009.
The inspection also found that the facility, which is situated in a densely populated suburban area, failed to maintain documentation for quantities of ethylbenzene, tetracycline hydrochloride, and xylene that were manufactured, processed or otherwise used at the facility during 2007.
What We Learned:
We learned that environmental non-compliance issues are sneaky. The facility had been making this error in reporting since at least 2009. The USEPA inspection occurred in 2010 and the government finally settled the case with an enforcement action and penalty just last week!
The facility may have been able to prevent this back in 2009 if it had a better method of managing its chemicals. The ability to cross reference regulatory information to the chemicals being used in the manufacturing process is critical to compliance with several local, state, and federal environmental regulations, including regulations such as: Form R, Tier II, air permitting, hazardous waste characterization and SPCC. In other words, due to the dynamic nature of most manufacturing operations, EHS personnel at a facility need to be able to understand which regulations apply to which chemicals are being used, processed, manufactured, stored and transported.
An ideal method of organizing, managing and analyzing chemical data is to put it into an electronic format. An electronic format will allow the EHS personnel to sift through chemicals and regulations with one click of a button. Reports and data can be converted to various formats (pdf, excel, etc.) so that this information can be further analyzed and communicated to effected stakeholders in the process. Safetec Compliance Systems, Inc. offers such a system and we would be happy to speak to you about it. Please contact us at your earliest convenience for further information about how we can help you be proactive in managing chemical risk.