The Phylmar Group. Inc. Newsletter
May 2016
Issue # 76:  New Technology to Help Regulators Know Which of the 80,000 Manufactured Chemicals Pose Risks;  EPA Proposes Changes to Risk Management Programs Under the Clean Air Act  

May 2016

Dear Subscriber,  

Welcome to the May 2016 edition of the Phylmar Newsletter. 
We begin with a report from a team of federal government researchers, who have successfully tested a new method to more quickly and cheaply collect data that can help define the potential human health risks for more than 80,000 chemicals now in commerce and the environment.  The new computer data analysis will make it possible to start defining levels at which chemicals might cause harm to humans and then to select those chemicals in the environment that should be more fully assessed.  The researchers believe it lays the groundwork for far-reaching advances in managing chemical risks in the United States and worldwide.
Next, we turn to the Environmental Protection Agency (EPA) and a proposal to amend its chemical Risk Management Program regulations under the Clean Air Act.  The rule applies to facilities (referred to as "stationary sources" under the CAA) that are subject to the chemical accident prevention requirements at 40 CFR part 68. This includes stationary sources holding more than a threshold quantity (TQ) of a regulated substance in a process. Approximately 12,500 facilities have filed current RMPs with EPA and are potentially affected by the proposed rule changes.  
Finally, we want to remind folks to come visit the PhylmarTV channel on YouTube to find videos covering a variety of topics for the EHS/Sustainability professional.

As always, please provide us with any feedback you might have and let us know if there is a topic that you'd like us t o cover in future newsletters .
Mark Katchen, CIH
Managing Principal 
The Phylmar Group, Inc.

New Technology Lays Foundation to Help Regulators Know Which of the 80,000 Manufactured Chemicals Pose Risks

A team of federal government researchers successfully has tested a new method to more quickly and cheaply collect data that can help define the potential human health risks for more than 80,000 chemicals now in commerce and the environment.  The researchers believe it lays the groundwork for far-reaching advances in managing chemical risks in the United States and worldwide.

The new approach, described in the study Using In Vitro High-Throughput Screening Data for Predicting Benzo[k]Fluoranthene Human Health Hazards, will help government regulatory agencies, such as the Environmental Protection Agency, decide which among the thousands of chemicals should receive greater scrutiny first. Priorities would be set on the basis of chemicals' potential hazardous effects on humans and on their potential to get into human lungs and other organs.

Using rapidly evolving computer-based methods to integrate data and information from many sources, the researchers say, will make it possible to start defining levels at which chemicals might cause harm and then to select those chemicals in the environment that should be more fully assessed.  That ability has long been recognized as a critical unmet need.

"In my opinion, this work is starting to lay the foundation that will allow risk assessors and risk managers around the world to couple high-throughput screening tests and adverse outcome pathways for risk assessment," says Dr. Lyle D. Burgoon of the U.S. Army Engineer Research and Development Center in Research Triangle Park, N.C.

Quantitative high-throughput screening (qHTS) uses robotics and other technological devices that allow researchers to quickly conduct millions of chemical tests.  Adverse outcome pathways, or AOPs, trace changes in biological systems that lead to harmful effects.

To assess the usefulness of the qHTS-AOP approach, Burgoon worked with colleagues Ingrid Druwe, Kyle Painter and Erin Yost from the Oak Ridge Institute for Science and Education, who were assigned to the EPA National Center for Environmental Assessment.  Their research used the cancer-causing chemical Benzo[k]Fluoranthene to pilot test the promising chemical risk assessment method and was published in the online version of Risk Analysis, a publication of the international Society for Risk Analysis.

The research focused on Benzo[k]Fluoranthene's putative ability to cause steatosis, a cell disease in which excess fatty molecules build up in cells.  It also focused on the chemical's potential to damage DNA as a result of oxidation, which can cause electron losses associated with some diseases and cancers.

Burgoon says the qHTS-AOP approach especially is critical for the chemicals currently in the environment for which data are lacking.  "High-throughput screening provides an avenue to get more data on these chemicals in a shorter amount of time, at an overall lower cost.  As scientists generate more data from these high-throughput tests, our approach will allow these data to be integrated together, to create a better sense of what a safe exposure may be."  
Ideally, risk assessors would use qHTS data in combination with reverse dosimetry data and models.  Such data are based on levels of chemicals found in biological samples (from human hair, blood, etc.).  The samples are used to define chemical levels in the environment that caused the exposures, but data derived from reverse dosimetry are currently insufficient.

Until the gap in reverse dosimetry data can be filled, the qHTS method will allow chemicals to be ranked for regulatory attention.  Priorities will depend on which chemicals the qHTS tests find are potentially more harmful relative to other chemicals.   Those findings will be paired with real-world data on how much of the chemical is found in air, water, or other places.

"Overall, we feel confident that as more qHTS data become available we will be able to translate these into risk assessment research needs and risk screening assessments," the authors write in the study.  "We are equally confident that transparency can be enhanced over time, as we continue to migrate towards more computationally-efficient, semi-automated methods."

To view the study go here
EPA Proposes Changes to Risk Management Programs Under the Clean Air Act
Excerpts from the executive summary of the Risk Management Programs proposed rule,, April 21, 2016
The proposed revisions include several changes to the accident prevention program requirements including an additional analysis of safer technology and alternatives for the process hazard analysis for some Program 3 processes, third-party audits and incident investigation root cause analysis for Program 2 and Program 3 processes, enhancements to the emergency preparedness requirements, increased public availability of chemical hazard information, and several other changes to certain regulatory definitions and data elements submitted in risk management plans. These proposed amendments seek to improve chemical process safety at facilities that use and distribute hazardous chemicals, assist local emergency authorities in planning for and responding to accidents, and improve public awareness of chemical hazards at regulated sources.
In response to catastrophic chemical facility incidents in the United States, President Obama issued Executive Order 13650, "Improving Chemical Facility Safety and Security," on August 1,2013. Section 6(a)(i) of Executive Order 13650 requires that various Federal agencies develop options for improved chemical facility safety and security that identify "improvements to existing risk management practices through agency programs, private sector initiatives, government guidance, outreach, standards, and regulations." One agency program presently in existence is the Risk Management Program implemented by EPA under section 112(r) of the Clean Air Act (42 U.S.C. 7412(r)). Section 6(c) of Executive Order 13650 requires the Administrator of EPA to review the chemical hazards covered by the Risk Management Program and expand, implement and enforce the Risk Management Program to address any additional hazards.
Summary of the Major Provisions of the Regulatory Action
This action proposes to amend EPA's Risk Management Program regulations at 40 CFR part 68. These regulations apply to stationary sources (also referred to as "facilities") that hold specific "regulated substances" in excess of threshold quantities. These facilities are required to assess their potential release impacts, undertake steps to prevent releases, plan for emergency response to releases, and summarize this information in a risk management plan (RMP) submitted to EPA. The release prevention steps vary depending on the type of process, but progressively gain specificity and rigor over three program levels (i.e., Program 1, Program 2, and Program 3).
The major provisions of this proposed rule include several changes to the accident prevention program requirements, as well as enhancements to the emergency response requirements, and improvements to the public availability of chemical hazard information. Certain proposed provisions would apply to a subset of the processes based on program levels described in 40 CFR part 68 (or in one case, to a subset of processes within a program level).
      Accident Prevention Program Revisions
This action proposes three changes to the accident prevention program requirements. First, the proposed rule would require all facilities with Program 2 or 3 processes to conduct a root cause analysis as part of an incident investigation of a catastrophic release or an incident that could have reasonably resulted in a catastrophic release (i.e., a near-miss). This provision is intended to reduce the number of chemical accidents by requiring facilities to identify the underlying causes of an incident so that they may be addressed. Identifying the root causes, rather than isolating and correcting solely the immediate cause of the incident, will help prevent similar incidents at other locations, and will yield the maximum benefit or lessons learned from the incident investigation.
Second, the proposed rule would require regulated facilities with Program 2 or 3 processes to contract with an independent third-party to perform a compliance audit after the facility has a reportable release. Compliance audits are required under the existing rule, but are allowed to be self-audits (i.e., performed by the owner or operator of the regulated facility). This provision is intended to reduce the risk of future accidents by requiring an objective auditing process to determine whether the owner or operator of the facility is effectively complying with the accident prevention procedures and practices required under 40 CFR part 68.
The third proposed revision to the prevention program would add an element to the process hazard analysis (PHA), which is updated every five years. Specifically, owners or operators of facilities with Program 3 regulated processes in North American Industrial Classification System (NAICS) codes 322 (paper manufacturing), 324 (petroleum and coal products manufacturing), and 325 (chemical manufacturing) would be required to conduct a safer technology and alternatives analysis (STAA) as part of their PHA, and to evaluate the feasibility of any inherently safer technology (IST) identified. The current PHA requirements include consideration of active, passive, and procedural measures to control hazards. The proposed modernization effort continues to support the analysis of those measures and adds consideration of IST alternatives. The proposed provision is intended to reduce the risk of serious accidental releases by requiring facilities in these sectors to conduct a careful examination of potentially safer technology and designs that they could implement in lieu of, orin addition to, their current technologies. Data compiled from RMPs suggest processes in these NAICS codes have a disproportionate share of reportable releases.
At this time, EPA is not proposing any additional requirements either for location of stationary sources (related to their proximity to public receptors) or emergency shutdown systems. However, EPA seeks comment on whether such requirements should be considered for future rulemakings, including the scope of such requirements, or whether the Agency should publish guidance.
Emergency Response Enhancements
This action also proposes to enhance the rule's emergency response requirements. Owners or operators of all facilities with Program 2 or 3 processes would be required to coordinate with the local emergency response agencies at least once a year to ensure that resources and capabilities are in place to respond to an accidental release of a regulated substance. As a result of improved coordination between facility owners and operators and local emergency response officials, EPA believes that some facilities that are currently designated as non-responding facilities may become responding facilities (i.e., develop an emergency response program in accordance with § 68.95).
Additionally, all facilities with Program 2 or 3 processes would be required to conduct notification exercises annually to ensure that their emergency contact information is accurate and complete. This provision is intended to reduce the impact of accidents by ensuring that appropriate mechanisms and processes are in place to notify local responders when an accident occurs. One of the factors that can contribute to the severity of chemical accidents is a lack of effective coordination between a facility and local emergency responders.
This action also proposes to require that all facilities subject to the emergency response program requirements of subpart E of the rule (or "responding facilities") conduct a full field exercise at least once every five years and one tabletop exercise annually in the other years. Responding facilities that have an RMP reportable accident would also have to conduct a full field exercise within a year of the accident. The purpose of this provision is to reduce the impact of accidents by ensuring that emergency response personnel understand their roles in the event of an incident, that local responders are familiar with the hazards at a facility, and that the emergency response plan is up-to-date. Improved coordination with emergency response personnel will better prepare responders to respond effectively to an incident and take steps to notify the community of appropriate actions, such as shelter-in-place or evacuation.
      Enhanced Availability of Information
This action proposes various e nhancements to the public availability of chemical hazard information. The proposed rule would require all facilities to provide certain basic information to the public through easily accessible means such as a facility Web site. If no Web site exists, the owner or operator may provide the information at public libraries or government offices, or use other means appropriate for particular locations and facilities. In addition, a subset of facilities would be required, upon request, to provide the Local Emergency Planning Committee (LEPC), Tribal Emergency Planning Committee (TEPC) 2 or other local emergency response agencies with summaries related to: Their activities on compliance audits (facilities with Program 2 and Program 3 processes); emergency response exercises (facilities with Program 2 and Program 3 processes); accident history and investigation reports (all facilities that have had RMP reportable accidents); and any ISTs implemented at the facility (a subset of Program 3 processes). The proposed rule would also require all facilities to hold a public meeting for the local community within a specified timeframe after an RMP reportable accident.
In addition to the major provisions described previously in this section, this action proposes revisions to clarify or simplify the RMP submission. These changes are intended to reduce the compliance burden on facilities and increase their understanding of the RMP requirements. We are also proposing technical corrections to various provisions of the rule.

To view the proposed rule and for more information go here.

Upcoming Events
Upcoming Environmental, Health, Safety and Sustainability Events

Global Reporting Initiative Global Conference, Amsterdam, Netherlands, May 18-20, 2016

AIHce 2016, Baltimore, MD, May 21-26, 2016

Shanghai Chemicals Summit, Shanghai, China, June 21-22, 2016

15th Annual Sustainability Summit , New York, NY, June 22-23, 2016

Safety 2016, Atlanta, GA, June 26-29, 2016
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