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Environmental Requirements for Chemicals & Pharmaceuticals

Trinity helps chemical and pharmaceutical manufacturers to achieve regulatory and environmental compliance with complex environmental regulatory requirements while producing the chemicals and pharmaceuticals on which people depend.  We have completed nearly 400 projects for chemical and pharmaceutical clients in the last two years.  These project experiences, combined with our individual involvement with various associations and support groups, keep us informed about the many issues facing these industries.

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Environmental Requirements - Regulatory Round Up

Recent Articles

EPA's MON Proposal - a New Focus on Operational and Maintenance Behavior

EPA completed its Residual Risk and Technology Review (RTR) for the Miscellaneous Organic NESHAP (40 CFR 63, Subpart FFFF - the MON), with proposed changes to this regulation published December 17, 2019. This article outlines some key changes in the MON proposal.


The CAA's Residual Risk and Technology Review: an Imminent Tightening of Regulations for the MON and Other SOCMI Sources 

The U.S. Environmental Protection Agency (EPA) is required to conduct Residual Risk and Technology Reviews (RTRs) of its own regulations governing hazardous air pollutants (HAPs) under the Clean Air Act (CAA) a minimum of every eight (8) years. The EPA has missed the deadline for several of these reviews and is now under court order to complete RTRs for thirty-three (33) source categories with upcoming due dates. RTRs for seven (7) of those source categories were completed, with RTRs for twenty-six (26) source categories remaining.


EPA RTR Reviews - Are They Following a Predictable Pattern? 

The U.S. Environmental Protection Agency (EPA) has completed the Residual Risk and Technology Reviews (RTRs) for Refinery MACT I and II (40 CFR 63, Subparts CC and UUU) in December 2015, and now the HCl MACT (40 CFR 63, Subpart VVVVV) in February 2019. The proposed amendments for these source categories closely resemble each other - making modifications to the same general sections of each regulation.

While these amendments are by no means "one-size-fits-all" and amendments must be tailored to fit the needs of each source category, and these changes to the Refinery MACT and the HCl MACT clearly foreshadow what we can expect EPA to propose for the upcoming chemical industry RTRs. As such, the chemical industry can expect similar source category specific modifications as outlined in this article.



Facilities subject to the provisions in 40 Code of Federal Regulations (CFR) Part 61, Subpart FF "National Emission Standard for Benzene Waste Operations" (commonly known as the BWON) include chemical manufacturing plants, coke by-product recovery plants, and petroleum refineries. Additionally a hazardous waste treatment facility that receives benzene containing waste from chemical manufacturing plant, coke by-product recovery plant, or a petroleum refinery and treats, stores, and/or disposes of the benzene waste.

One of the cornerstones of the BWON is appropriately identifying the points of waste generation (POGs) at the facility. A common mistake is made, typically by chemical industry, when identifying POGS and confusing them with Points of Determination (PODs). PODs are used for wastewater provisions under some MACT standards (e.g., HON, MON, Pharma MACT, Pesticide MACT, etc.). As an example, 40 CFR 63 Subpart G (the HON) defines POD in 40 CFR 63.111.


The Latest on Ethylene Oxide

The U.S. Environmental Protection Agency (EPA) announced on August 22, 2018, that it was taking steps to address Ethylene Oxide (EO) emissions from industrial facilities across the country based upon results of the latest National Air Toxics Assessment (NATA) update. The latest NATA update was released by EPA the same day and identified EO as a significant contributor to potential elevated cancer and other significant health risks.

The American Chemistry Council (ACC) believes the EO inhalation unit risk estimate from EPA's IRIS Database is based upon a flawed IRIS Assessment that does not provide a realistic basis for the management of health risks posed by EO.


Understanding Toxchem
Facilities in the chemical and refining industries will, at some point, need to calculate emissions from wastewater systems, whether for calculating potential to emit for permitting or actual emissions for emissions reporting requirements. If your facility is dusting off that old Water9 report from 2005, then perhaps now is the time to determine if a switch to Toxchem, a wastewater emissions modeling software developed by Hydromantis, is right for you.


Wastewater Treatment From an Air Perspective
You don't smell wastewater. You smell the air emissions from the wastewater. Thus, there is a compelling logic to the multimedia regulations that address wastewater as a source of air emissions. These regulations took an interesting path to the fairly accepted status they have now. Among the earliest such regulations was NSPS Subpart QQQ, which sought to reduce air emissions from petroleum refinery oily wastewaters, focusing on sewer systems and phase separation. The Benzene Waste Operations NESHAP then also addressed air emissions from the treatment processes. The later-promulgated HON rule added a great deal of complexity to the topic by defining different types of wastewaters, constituent-specific removal targets, and so on, and this approach has carried over to the MON, Pharma MACT, and subsequent wastewater-related rules.

These rules strive to reduce air emissions by focusing on how to manage wastewaters, with less attention paid to calculating the air emissions themselves. The spotlight is on wastewater composition as a representation of potential-to-emit, and it is this potential the regulations address in their different ways.