In the world of pharmaceuticals, while environmental planning may not be at the top of to-do lists for many regulatory affairs managers, it just might be worth considering the regulatory fall-out from an act that was last amended in 1990, and has only recently begun to take full effect.
The Clean Air Act, as amended by President Bush Senior, is principally concerned with eliminating dangerous chemicals from the atmosphere we breathe. Significantly, the act also authorizes the Environmental Protection Agency (EPA) to establish national emission standards for hazardous air pollutants (NESHAP). Of note for pharmaceutical manufacturers are the standards known as the Pharmaceuticals Production MACT, which currently controls air toxics from pharmaceutical operations and a process known as maximum achievable control technology (MACT). Now the organic chemical manufacturing industry, which supplies the feedstocks for pharmaceutical manufacturers and other industries, is faced with its own MACT known as the Miscellaneous Organic NESHAP (MON). This rule will require chemical manufacturers to reduce air toxics emissions and is anticipated to affect approximately 100 production facilities across the U.S.
The EPA may not possess such sharp regulatory teeth as the U.S. Food and Drug Administration, but it does have a history of enforcing penalties. Take a sampling of recent charges for example: in June this year it was announced that the Merck and Co. pharmaceutical research facility at West Point, Pa., may face fines for a cyanide-related discharge, which killed 1,000 fish, and was not in accordance with the company’s protocols for proper waste disposal; also in June JLM Chemicals was cited for failure to comply with leak detection and repair requirements at the company’s chemical manufacturing plant in Blue Island, Ill.; finally in May 2000 Janssen Ortho LLC began the long-term cleanup of chemically contaminated soil at its facility in Gurabo, Puerto Rico, stemming from a voluntary notification to the EPA in 1989.
Companies clearly require systems to monitor processes and emissions so they can avoid potentially damaging the environment, financial penalties, and negative press, so senior management can assert with confidence that they comply with all the government requirements.
Unsurprisingly, compliance activities require the processing of a frightening amount of data. Environmental obligations must be identified and tracked, which means volumes of data need to be collected, stored, organized, interpreted, checked against standards, acted upon and reported to a regulatory agency (something the EPA calls the “plan, do, check and act” model). Many commercial solutions exist, but one company in particular is leveraging a familiar technology to meet these challenges and improve data accessibility.
For the past thirteen years Dixon Environmental has provided environmental services to the chemical, refining, and pharmaceutical industries. In May 2005, the company teamed up with Enviance and launched MONITOR™, an internet-based environmental compliance program and information system. Combined with the online MON Resource Center™—developed with the Synthetic Organic Chemical Manufacturing Association (SOCMA)—Dixon helps its clients achieve MON compliance. While initially developed for the MON rule, this approach has potential applicability to a variety of EPA regulations including the Pharmaceuticals Production MACT.
One of the things that sets Dixon apart is an expert system feature built onto the front end of their MONITOR solution which can read a clients data and tell the client what their environmental obligation is (the plan and do stage).
“Most of our work is related to meeting some kind of emission standard or helping companies obtain permits for new facilities or making changes to a facility,” says Michael R. Dixon, president of Dixon Environmental.
A manufacturing company’s environmental obligation can take many different forms; it could be an emissions limit which can’t be exceeded or a work practice that’s required.
“You end up with these…operating permits that are two or three inches thick with all the obligations that have to be done, tracked, monitored and reported,” says Dixon, “and [the MON rule] is going to add so many additional obligations.”
The web services platform acts like a “central repository” for all the clients’ data, which is accessible from any location and archived in anticipation of regulatory audits, “not only is all the data in one location but all of the backup data is in one spot too,” adds Dixon. Data is stored on an AT&T operated and secured facility in California.
One way to keep those audit costs down is to implement a proactive environmental management system (EMS) with internal limits set below those of the regulators.
“If there is [an obligation] that you are getting ready to exceed you get an e-mail notification before that happens so you can take action and make a repair or whatever you have to do before you exceed the regulatory limit. We build that right into MONITOR,” says Dixon, adding, “by listing out all the obligations and who’s doing what and having a tracking system assigned to it along with an escalation system, if someone misses an obligation the system notifies a superior. So once you have a robust EMS system in place the audit is more perfunctory and it can be driven off the information system.”
The web solution also facilitates direct communication and allows Dixon’s environmental management staff to work collaboratively with the client organization—eliminating the usual delays caused by travel.
“Really, the web-solution is the only way to go,” says Dixon. “Before that you completed a batch of spreadsheets and sent them [to the client] through e-mail and they got lost or corrupted, a million things can happen and cause a lot of problems.”
Many firms emphasize the benefits of web-based services for industries operating global supply chains, Dixon is no different. The advocates of these services say that contracted organizations operating in different parts of the supply chain can more easily access up-to-the-minute information—“web services have all kinds of applications that people haven’t even looked at yet,” says Dixon.
Traditionally, one of the biggest challenges for EMS is how to keep up with the rapidly evolving environmental obligations. Dixon claims his solution overcomes these obstacles with live links to the electronic Code of Federal Regulations (eCFR), enabling his clients to keep up to date with their regulatory responsibilities.
As environmental issues take center stage in regulatory affairs, particularly as concerns mount over rising greenhouse gas emissions, the organizations that consider their responsibilities seriously are likely to be the ones that avoid the stern gaze of regulatory authorities.