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.

Environmental Requirements - Regulatory Round Up

Recent Articles

Major Gains: The LDAR Auditing Effect - June 22, 2018

Is your facility subject to leak detection and repair (LDAR) requirements? Are you concerned with potential compliance gaps in your LDAR program? If so, whether your facility currently has LDAR audit requirements or not, now is the time to consider the benefits of performing an LDAR audit or gap assessment at your facility. LDAR has been at the heart of EPA enforcement activity for over a decade and is expected to remain an EPA priority for years to come. LDAR enforcement has spanned various industries, namely chemicals, refining, and oil & gas facilities, and numerous regulations, including NSPS, NESHAP, and MACT standards. Additionally, EPA recently expanded their National Enforcement Initiatives to included LDAR programs for hazardous waste treatment, storage, or disposal facilities regulated under the Resource Conservation and Recovery Act (RCRA). LDAR-related enforcement activities typically lead to implementation of enhanced LDAR requirements, including more stringent leak definitions, development of written LDAR programs and procedures, and requirements to conduct LDAR audits. In many cases, auditing the LDAR program prior to an EPA inspection can alleviate compliance issues, potentially preventing requirements to implement enhanced LDAR as well as steep financial penalties. At first thought, LDAR audits may appear to serve a single purpose: identify areas of non-compliance with applicable regulatory requirements. However, when performed correctly, these audits can be much more beneficial to your facility. While detecting areas of direct non-compliance is an integral part of the audit process, insight related to EPA's LDAR expectations and knowledge of industry best practices are important as well. Awareness of EPA expectations allows the facility to get up-to-speed with hot topics and EPA priorities that are not directly spelled out in regulation. Implementing industry best practices ensures your facility operates a state-of-the-art LDAR program. Coupling these items reduces compliance risk moving forward. Whether already required through a consent agreement or undertaken as a precautionary measure, LDAR audits are useful tools to gauge compliance status. Utilizing experience related to LDAR compliance, auditing, and enforcement assistance for numerous facilities in the chemical, refining, and oil & gas industries, Trinity's LDAR audit team is well-suited to guide your facility through the complex maze of LDAR compliance. If you need assistance evaluating your current compliance status or performing a Consent Decree-required audit, or have any questions regarding Trinity's LDAR capabilities, please contact Inaas Darrat, P.E., at 713-552-1371 or Dan Smith, at 610-280-3902.

Wastewater/Hazardous Waste Sampling Plans - June 22, 2018

Developing thorough wastewater and hazardous waste sampling plans can be the difference between a smooth process of demonstrating compliance with applicable requirements and a long road of validating and justifying waste determinations. Detailed sampling plans help a facility to: verify that all waste streams have been evaluated against the appropriate regulatory criteria, effectively coordinate with sampling teams and analytical laboratories, and ensure the samples taken are representative of normal operations. Some of the more common wastewater and hazardous waste rules include but not limited to:

  • Wastewater requirements under source category regulations contained within 40 CFR 63 (Subpart G (HON), Subpart GGG (Pharma MACT), Subpart FFFF (MON), etc);
  • Benzene Waste Operations NESHAP (BWON) of 40 CFR 61, Subpart FF;
  • Resource Conservation and Recovery Act (RCRA) Subpart CC hazardous waste; and

Due to a number of factors, it is typically impractical to develop a single sampling plan for all potentially applicable regulations. For example, what and where in a process a material is considered a “waste” differs between the rules. As such, the sampling locations can be vastly different for each regulation. For example under the HON, Pharma MACT, and MON, a stream becomes wastewater once it exits a chemical manufacturing process unit or control device. This location is referred to as the point of determination (POD). Under BWON, the applicability assessment is performed based on the point of generation (POG), which represents the location where the waste stream exits the process equipment, but prior to any handling or treatment in an operation that is not an integral part of the production process. As such, a POG can often occur upstream from where an associated POD is located. With some exceptions, the material that is potentially subject to hazardous waste requirements under RCRA Subpart CC expands even further. As a facility-wide requirement, you are no longer exclusively evaluating material from process units for this rule. Additionally, just because a material is subject to applicable requirements under rules such as the HON, MON, Pharma MACT, or BWON does not mean that it is exempt from requirements for hazardous waste. The sampling and analytical methods used to determine wastewater and hazardous waste requirements also vary among the rules. For the HON/MON/Pharma MACT, there are a number of options; however, Method 25D of 40 CFR 60, Appendix A and Method 305 of 40 CFR 63, Appendix A are specifically identified for use. Neither of these test methods are approved under BWON, which instead provides a list of six (6) acceptable test methods, where Method 8260 is most common. Unlike the HON, MON, and BWON, evaluation of hazardous waste requirements for RCRA Subpart CC often warrants multiple samples and analytical test methods. Materials may need to be tested for one or more of the four (4) hazardous waste characteristics: ignitability, corrosivity, reactivity, and toxicity. For waste which exhibits one of more of the hazardous waste characteristics, the facility must then determine the volatile organic concentration of the material in order to assess the applicable requirements under RCRA Subpart CC. Having detailed documentation for specific sample locations, identifying when samples can be taken, and describing the procedures to be employed can greatly help reduce complexities of coordinating with all involved parties (i.e., plant personnel, samplers, and the lab) and ensure that the appropriate samples are taken for each location. If you have an immediate concern and require assistance with this, please contact Kati Petersburg at 720-638-7647. 

What's in Your Plan, Stan? - April 17, 2017

When it comes to Leak Detection and Repair (LDAR) programs, many facilities utilize written LDAR programs (sometimes known as LDAR Monitoring Plans). In some instances, facilities are required to develop and maintain LDAR Monitoring Plans as part of the requirements in a Consent Decree (CD). However, EPA also recommends that an LDAR Monitoring Plan be developed as a “best practice” in order to “increase the effectiveness of an LDAR program”1.

While LDAR Monitoring Plans can vary from facility to facility (depending on the existing LDAR program), there are a few key elements that are seen in almost every plan. 

  • A list of LDAR applicable units and their associated regulations
  • Documentation of requirements specific to different types of equipment
  • Procedures associated with Management of Change (MOC) for ensuring that new LDAR applicable components are added to existing database and monitoring routes
  • Description of roles and responsibilities for LDAR personnel
  • How to conduct and record audio, visual and olfactory (AVO) inspections
  • Procedures associated with leaking equipment typically including (but not limited to):
    • Methods for monitoring
    • Leak repair
    • Equipment replacement
    • Recordkeeping measures 

In many cases, the requirements for what goes into an LDAR Monitoring Plan are flexible and the monitoring plan can be used to encompass the LDAR program for an entire subject facility. In other situations, this is not the case.

For sources subject to the requirements under the newly promulgated 40 Code of Federal Regulations (CFR) Part 60, Subpart OOOOa (NSPS OOOOa), there are more strict requirements for developing an LDAR Monitoring Plan. Specifically, LDAR Monitoring Plans required under NSPS OOOOa must be made for each company-defined area encompassing compressor stations and well sites and incorporating the requirements of 40 CFR 60.5397a(c)-(d). It should be noted that the items required to be included in such plans have previously been mirrored in EPA's recommendations for best practices and consent decrees.

It is important to keep in mind that regulation and CD required LDAR Monitoring Plans must be reviewed in great detail to ensure that both the regulations and the intent behind the requirements of the regulations are being met. Facilities should confirm that the LDAR Monitoring Plan does not contradict facility-specific practices or regulations. For facilities with CDs, the Monitoring Plan becomes another requirement for demonstration of compliance depending on the wording of the CD.

In general, the LDAR Monitoring Plan should be the ultimate reference guide for anything related to LDAR at a facility. It should be made accessible to any personnel at the facility to ensure that roles and responsibilities are made clear to all members of the LDAR program. Most importantly, the LDAR Monitoring Plan should be reviewed and updated whenever changes are made to the LDAR program so that the most current information related to the facility's LDAR program can be relayed to all appropriate members of the team. For assistance evaluating your compliance with LDAR requirements, or for any questions regarding Trinity's LDAR capabilities, please contact Inaas Darrat, P.E., at 713-552-1371, ext 209, or Dan Smith, at 610-280-3902, ext 306.

EPA OIG's Research on High Risk Chemicals Reported in TRI and RMP - Jun 15, 2016

Does your facility submit Form Rs or Form As for Toxic Release Inventory (TRI) reporting every year? Is your facility subject to the requirements under the Risk Management Program (RMP)? If your answer is yes to both questions, now is a good time to review the data reported to these two programs for consistency; if your answer is yes to one of questions, now is a good time to consider if the other program is applicable to your facility. 

A recent memorandum revealed that the Office of Inspector General (OIG) for the U.S. Environmental Protection Agency (EPA) plans to begin preliminary research to identify unregulated facilities using data from the TRI. For the annual TRI reporting, facilities supply various data on toxic chemical releases and other waste management activities in Form R and/or Form A. These data then become public available. Due to the overlap of the regulated chemicals under different programs, the published TRI data can be utilized to identify deficiencies in other environmental programs such as RMP, National Pollutant Discharge Elimination System (NPDES) permitting and etc. Learn more.  

EPA National Enforcement Initiatives Expanded to Include RCRA LDAR - Jun 15, 2016

If your plant operations include hazardous waste treatment, storage, or disposal facilities regulated under the Resource Conservation and Recovery Act (RCRA), now is the time for you to tune in! U.S. EPA's on-going National Enforcement Initiatives (NEIs) targeting leaks, flares and excess emissions from refineries, oil and gas, and chemical plants are expanding to specifically address air emissions from hazardous waste generator and treatment, storage and disposal facilities and large product storage tanks. Under the expanded NEIs, EPA will emphasize enforcement for violations of the RCRA Subpart BB leak detection and repair (LDAR) requirements for the above mentioned RCRA facilities. Learn more.

EPA Targets Flaring Efficiency - Sep 30, 2015

EPA MON Enforcement: Now with More BWON - Sep 30, 2015

Proposed Updates to National Enforcement Initiatives - Sep 30, 2015

Toxchem for Estimating Wastewater Emissions - Sep 30, 2015    

Both chemical and pharmaceutical facilities recently have been burdened with a number of additional emission control requirements, in the form of Maximum Achievable Control Technology (MACT) standards. The cost of the emission control equipment, in conjunction with the necessary administrative systems, has placed additional financial burden on the already strapped resources of these companies.

A significant regulatory concern for both of these industries includes the Miscellaneous Organic Chemical Manufacturing and Coating NESHAP (MON) and particularly for the chemical industry, the Organic Liquid Distribution MACT. The MON is projected to impact several thousand facilities with batch processing operations. Older facilities will be most significantly impacted through the required controls of wastewater streams. Modifications to the proposed MON to modify the requirements for soluble Hazardous Air Pollutants (HAPs) is an important change to minimize the potential impacts of this regulation.

With the promulgation of the New Source Review reform elements and the implementation of MACT requirements, the chemical and pharmaceutical industries will have to assess their compliance status in order to minimize future production costs while increasing production responsiveness to market demands.

Consultant Spotlight

KPetersburgMs. Kati Petersburg is a Managing Consultant in Trinity's Denver office with over 15 years of professional experience, working both directly for industry and as a consultant. Ms. Petersburg is a key contributor to Trinity's Benzene Waste Operations NESHAP team. Her extensive BWON work covers the range of applications and includes specific experience, such as developing and managing compliance programs, developing BWON programs, and conducting BWON audits. Kati's broad experience in comprehensive EHS compliance enables her to coordinate the BWON program into a facility's overall compliance success. While her primary focus is industrial permitting and compliance, Ms. Petersburg also has significant experience in auditing environmental compliance programs, environmental and health and safety investigations, and industrial wastewater treatment.

Kati is a mother of two (girl - 11, boy - 2) and has a passion for mountain biking and skiing. Although she has lived in Colorado for 20 years, her heart remains in Michigan's Leelanau Peninsula, where she and her family have spent summers since she was young.

Project Profiles

  • For a multi-national chemical company, T3, a division of Trinity Consultants, developed an EMIS to obtain the production data, laboratory data, and inventory information from existing data management systems.  These consolidated data were used to prepare regulatory reports for air, water, waste and community right-to-know environmental programs.
  • For a polyether/polyols chemical production facility, Trinity helped to implement a start-up, shutdown, and malfunction (SSM) monitoring tool.  With the change in the 40 CFR 63 Subpart A requirements for the reporting of SSM events, this tool enables the facility to easily track, record and report SSM events as required by the MACT requirements.
  • For a chemical manufacturing facility, Trinity characterized the emissions and waste discharge from production activities at the site.  The facility used this analysis to evaluate its compliance status with regard to a number of environmental programs. In an unforeseen side benefit, the organization identified operational improvements to improve the efficiency of emission control equipment and other processes at the facility.