Pharmaceutical MACT/NESHAP Rule Settlement
A Settlement Agreement announced on January 5, 2000, requires EPA to issue new proposed and final regulations addressing changes to the Pharmaceutical MACT. However, the basic thrust of the regulations will remain the same.
On September 21, 1998, EPA issued final MACT regulations for the Pharmaceutical industry. Under the MACT, regulated sources must generally reduce emissions from storage tanks, process vents, equipment leaks, and wastewater operations and implement a fugitive leak detection and repair (LDAR) program. Shortly after the rule's issuance, on November 20, 2998, PhRMA filed a petition in the U.S. Court of Appeals for the Distric of Columbia Circuit. PhRMA's petition challenged the final rules under judicial review provisions established for EPA rule making.
PhRMA released the following statement on EPA's final rules after filing the Petition:
"We applaud the agency's efforts to draft a rule that would achieve cost-effective emissions reductions without hindering essential operating flexibility and innovation, and tremendous strides were made toward that goal. But we don’t think that goal has been achieved as yet, and we hope our Petition will lead to a settlement of the matter in the near future."
Subsequent to PhRMA's Petition, Dow Chemical Company and the Chemical Manufacturers Association (CMA) joined the lawsuit as intervenors. The Settlement Agreement announced on January 5, 2000 essentialy clarifies what is a "regulated source" by clarifying certain definitions and providing additional technical guidance.
Isolated Intermediates: The Agreement makes clear that a process boundary is identified when storage occurs to help with defining the term "isolated intermediates" in the Rule. If product moves from Reactor A to Reactor B, this is considered on process. If product moves from Reactor A to storage Reactor B, you have two processes.
Standard Batch Concept: The Agreement also introduces the concept of the "standard batch" to simplify record keeping. Under the agreement, owners and operators of a source can use ranges of operating characteristics to define a standard batch. If the batch stays withing the ranges and the source has proven that batches within these ranges comply with the process vent standards, the source can simply record the number of standard batches to calculate air emissions.
Pharmaceutical Product: The Agreement also clarifies the definition of "pharmaceutical product" in the MACT standard. Now, the MACT standard applies to the manufacture of pharmaceutical active ingredients, final dosage products and the manufacture of precursor chemical(s) whose ultimate primary use is to be subsequently processed through additional chemical transformations and separations into final drug products and pharmaceutical active ingredients.
Precursors: The Agreement also clarifies that intermediate materials that are integral to the production of "active ingredients" are regulated. In other words, the term "precursor" means a material produced for the prupose of producing a pharmaceutical product.
Compliance Dates: Under the Agreement, existing sources have until October 21, 2002 to comply. New sources must comply with the MACT by the time the final rule is published or upon startup, whichever is later. Sources constructed or reconstructed between April 2, 1997 and September 21, 1998 have until September 21, 2001 to comply if certain conditions are met.
In essence, the Pharmaceutical MACT can be a problem or an opportunity. It can be viewed as a very expensive, burdensome requirement that generates enormous amounts of "red tape" and frustration. Or, it can be an opportunity to review the plant emissions in greater detail and to look for cost savings and potential production efficiencies. The choice is one of strategy and attitude based in knowledge of the rules and the production process.
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