Pill makers' emission reports: EPA renewal on autopilot
Published Date: 2/28/2025
Notice
Summary
The EPA is asking to keep collecting info from pharmaceutical makers about pollution controls for a few more years. This affects companies that produce medicines, helping the EPA track and reduce harmful air emissions. You’ve got until March 31, 2025, to share your thoughts, and there’s no new cost or big changes—just a renewal of the current rules.
Analyzed Economic Effects
3 provisions identified: 0 benefits, 3 costs, 0 mixed.
Mandatory reporting for drug makers continues
Owners and operators of pharmaceuticals manufacturing operations must continue to provide information under the NESHAP for Pharmaceuticals Production (40 CFR part 63, subpart GGG). The collection is mandatory, applies semiannually, and EPA estimates 27 respondents will spend a total of 44,300 hours per year and incur $5,750,000 per year in costs (including $174,000 annualized capital or operation & maintenance costs).
Which facilities are covered
The rule applies to existing and new pharmaceuticals manufacturing operations that are major sources of hazardous air pollutants and covers process vents, storage tanks, equipment components, and wastewater systems. New facilities covered include those that commenced construction or reconstruction after the date of proposal.
O&M cost adjustment increases estimated costs
EPA reports no change in total respondent hours but notes an increase in operation & maintenance (O&M) costs due to updating cost estimates from 2007 dollars to 2022 dollars using the Chemical Engineering Plant Cost Index (CEPCI). The ICR’s total estimated cost figure is $5,750,000 per year, which includes $174,000 in annualized capital or O&M costs.
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Key Dates
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