The alleged violations were discovered during an EPA inspection in June 2004 and from a July 2004 information request, and have ended with Abbott having to fork out a $57,372 (€44,000) fine, as well as undertake two environmental projects costing $418,300.
One of the projects involves enforcing an enhanced LDAR programme at the facility, with more frequent monitoring of equipment, setting more stringent leak repair standards, upgrading components, undertaking QA/QC audits in LDAR and carrying out an investigation to determine potential root causes and sources of leaks.
The other project requires Abbott to reduce vehicle pollution by replacing 27 of its Jeep Liberty Sport sales vehicles with Ford Escape hybrid vehicles by the end of the year and continuously use each hybrid vehicle for at least 37 months.
Still, the company believes that its LDAR programme is currently in compliance.
"There might have been leaks occurring at the facility, but an actual number is not known because Abbott either did not monitor each component when it should have or it monitored without using the proper method, giving an inaccurate reading," Raymond Cullen, environmental engineer in the EPA's Air Enforcement and Compliance Assurance Branch, told In-PharmaTechnologist.com.
"Equipment leaks are not a violation but not fixing a leaking component timely is."
According to the EPA, the higher the percentage of leaking equipment at a facility, the more frequent that facility must monitor its equipment.
The LDAR rules were written to develop schedules for periodic monitoring of equipment, and, if leaks are discovered, to schedule for fixing.
"The EPA understands that equipment occasionally leaks," Cullen added.
"In Abbott's case, we do not know if there were leaks or not, all we know is that they did not monitor all components when required or properly."
In the settlement, the EPA states that Abbot did not monitor all valves and connectors in gas/vapour and light liquid service as LDAR provisions dictate, and even failed to identify the equipment subject to such provisions.
Abbott also failed to inspect vapour suppression equipment, did not establish the correct minimum regeneration steam flow rate for the S-32 carbon adsorber and keep the adsorber above that value, and did not keep the pH of its scrubber SC-5003 above theestablished minimum value.
"Abbott believes that no adverse impact to the environment resulted from the issues alleged in the Finding of Violation (FOV)," Abbott spokesman Chris Bona said.
"As a global corporation with manufacturing operations in several countries, Abbott is concerned about and committed to protecting the environment."
Abbott would not say which drugs are made at the North Chicago facility but it is not the first time this plant has got the company in trouble with the EPA.
In August 2004 Abbott paid the EPA a $17,903 penalty to settle alleged violations of regulations to protect stratospheric ozone.
The complaint, filed at the time by the US administration, alleged that Abbott failed to repair chillers that leaked excessive amounts of chlorofluorocarbon (CFC) refrigerants and that the company violated planning, testing, retrofitting and retirement requirements for the chillers.
In response, Abbott undertook a $123,000 project, retrofitting two refrigeration units to use EPA-approved, non-ozone-depleting refrigerants.