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Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act

September 18th, 2017

As required under section 6(b)(4) of the Toxic Substances Control Act (TSCA), the EPA is issuing a rule that establishes a process for conducting risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment.  This is without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation, under the conditions of use.

This process incorporates the science requirements of the amended statute, including best available science and weight of the scientific evidence. Risk evaluation is the second step, after Prioritization, in a new process of existing chemical substance review and management established under recent amendments to TSCA. This rule identifies the steps of a risk evaluation process including: scope, hazard assessment, exposure assessment, risk characterization, and finally a risk determination. This process will be used for the first ten chemical substances undergoing evaluation from the 2014 update of the TSCA Work Plan for Chemical Assessments (to the maximum extent practicable). Chemical substances designated as High-Priority Substances during the prioritization process and those chemical substances for which EPA has initiated a risk evaluation in response to a manufacturer request, will always be subject to this process. The final rule also includes the required “form and criteria” applicable to such manufacturer requests.

As required under section 6(b)(1) of the Toxic Substances Control Act (TSCA), EPA is also issuing a final rule that establishes the process and criteria that EPA will use to identify chemical substances as either High-Priority Substances for risk evaluation, or Low-Priority Substances for which risk evaluations are not warranted at the time. The final rule describes the processes for formally initiating the prioritization process on a selected candidate, providing opportunities for public comment, screening the candidate against certain criteria, and proposing and finalizing designations of priority. Prioritization is the initial step in a new process of existing chemical substance review and risk management activity established under TSCA.

The EPA has als released a guidance document.  entitled “Guidance to Assist Interested Persons in Developing and Submitting Draft Risk Evaluations Under the Toxic Substances Control Act”. The document is intended to assist interested persons, or external parties, in developing and submitting draft risk evaluations to be considered by EPA under TSCA. The guidance document addresses the science standards, the data quality considerations, and the steps of the risk evaluation process that external parties should follow when developing draft risk evaluations for consideration by EPA


Safety in the Workplace, Higher Standards lead to Lower Risks

September 1st, 2017

Worker safety is crucial to smooth operation in any workplace, even more so in the manufacturing of potentially lethal materials.  The U.S. Occupational Safety and Health Administration (OSHA) sets strict safety standards for plants and organizations to follow to ensure that safety.  Learning and keeping up-to-date with these ever-changing regulations can be a challenge for even the largest firms.

Roger Corley has seen this first hand in his role as a materials manager.  Mr. Corley oversees the production of highly dangerous acids, caustics, and other potentially hazardous chemicals for Life Cycle Engineering.  He lends his expertise not just those working with hazardous materials, but any plant that wishes to reduce their chance of a workplace incident.

Getting Started: Workplace Safety

  • Plan all jobs ahead of time, regardless of their simplicity. Basic maintenance tasks can contribute to workplace accidents if improperly completed.  Having a plan, even for routine upkeep of your facility, cuts down on variance.
  • Physically visit the site of any ongoing task, even if doing so is inconvenient.  Have a firsthand account of the situation to reveal unexpected complications, before they interfere with your work.
  • Come prepared with basic supplies.  Record keeping tools, such as a voice recorder, can help you to remember details about the job after inspection.  Standard measuring tools, such as a Micrometer, helps ensure you obtain the required materials for that job.
  • Keep an eye out for changes in the workplace. Tiny changes add up, and can throw off a productive work environment.  If a part is replaced, know if the replacement is identical to the prior one.  If a production process is modified, find out why.  Keeping on top of these alterations to the workplace can help reduce surprises.
  • Keep a learning attitude no matter your experience level. New employees learning from veterans is crucial, but just as crucial is that veterans are held accountable to the highest standard.

Having a plan in place to anticipate and preempt potential challenges keeps risks to workers low, while also assisting in responding to anything unexpected.  Prepare for challenges, and even more important, be equipped to deal with them as they arise, which will help to ensure a safe and productive work place.

For more advice on process safety management, please click here for Mr. Corley’s full testimonial, or if you have questions, please feel free to contact us at


OSHA’s Final Rule on Silica Dust

May 6th, 2016

Background Information

Crystalline silica is an important industrial material found in sand, stone, rock, concrete, brick, block, and mortar and other materials in a wide variety of workplaces. Exposure occurs during cutting, sawing, drilling and other kinds of processing of these materials. Silica dust is hazardous when very small (respirable) particles are inhaled. Two new standards to protect employees are being issued by OSHA: one for general industry and maritime, and one for construction.

New Standard: Details

The final rule becomes effective on June 23, 2016. Under the new OSHA standard employers will be required to comply with the following when employees are working with silica or materials containing silica:

  • Document employee exposures to respirable crystalline silica which will require air sampling and retention of exposure results for 30 years
  • Ensure employees are not exposed to over 50 micrograms per cubic meter of air of silica over an 8 hour period
  • Develop engineering controls to reduce silica exposures
  • Limit exposure to silica dust
  • Develop exposure control plans
  • Offer medical exams
  • Train employees on how to limit exposure to silica
  • and more

Additional Resources

Additional information can be found at the links below. Contact ESC for assistance with implementing the requirements of this standard.


TSCA CDR Rule: Start preparing today to see if this reporting requirement applies to your facility!

April 26th, 2016

CDR rule has a broader applicability than the rest of TSCA

It applies not only to those who manufacture chemicals but also to those who only buy chemicals if some of those chemicals are purchased directly from foreign suppliers. In this case a company is defined as an “importer” of chemicals.

The Chemical Data Report (CDR) is collected every four years on certain chemicals in commerce. Reporting is generally triggered when volumes for the TSCA-listed chemicals are imported or manufactured over applicable thresholds. Even if your facility did not file the original Premanufacture Notice (PMN), you may still be required to submit a CDR.

The submission period for the 2016 CDR is from June 1, 2016, to October 31, 2016. This is a one time extension granted by the EPA for 2016 (deadline was September 30). Reports must be submitted electronically through the EPA’s Chemical Data Exchange (CDX). EPA uses the data to help assess the potential human health and environmental effects of these chemicals. Below is a list of updates that will impact reporting due in 2016. Need assistance reporting? Contact us.

Changes to the CDR Reporting for 2016

  • Facilities are required to report if the threshold is exceeded in any year from 2012 – 2015. Previously, reporting was only required if the threshold was exceeded during the principal reporting year.
  • The separate reporting threshold for processing and use information has been eliminated. This information now must be included for all reportable chemicals.
  • In general, the reporting threshold remains 25,000 lb per site. However, a reduced reporting threshold (2,500 lb) now applies to chemical substances subject to certain TSCA actions. The total annual production volume must be reported for 2012-2014. For 2015, facilities must report the domestically manufactured and imported amounts separately.
  • The list of chemical substances that are partially exempt from CDR reporting was amended by EPA.

Determining Which Chemicals Are Required to be Reported Can Be Difficult

TSCA reporting is a quadrennial reporting requirement with a significantly expanded reporting burden as a result of regulatory changes. The regulated community should start making plans now to successfully gather and report the required data. Common stumbling blocks include the following:

  • Did the facility import any TSCA listed chemicals above the applicable thresholds between 2012 and 2015? Directly imported chemicals are easy to overlook
  • Does the chemical meet the definition of manufactured for commercial purposes?
  • Does the facility generate any byproducts or impurities in their manufacturing process?
  • Is the manufactured chemical exempt from reporting?
  • Is the manufactured chemical subject to any TSCA actions which have a lower reporting threshold?
  • Does the manufactured chemical meet the article exemption?
  • Is the manufactured chemical partially exempt from reporting requirements?


TRI Reporting Year 2015 Update

April 14th, 2016

Now is the time to begin preparing for the Annual Toxic Release Inventory (TRI) Reporting deadline on July 1, 2016. Reporting is required by the EPA for facilities that manufacture, process, or otherwise use EPCRA Section 313 chemicals over applicable thresholds. These facilities must report the quantities of Section 313 chemicals on-site during the calendar year and the amount contained in wastes, managed on-site or transferred off-site. These facilities must also report routine and accidental releases, and releases resulting from catastrophic or other onetime events of EPCRA Section 313 chemicals. Below is a list of updates that will impact reporting due in July of 2016 as well as a look ahead to reports due in July of 2017. Need assistance reporting? Contact us.

New Reporting Requirement for Nonylphenol for Reporting Year 2015

The U.S. EPA has added a new chemical category (Nonylphenol category) to its TRI list of toxic chemicals subject to reporting under Section 313 (Toxics Release Inventory reporting) of the Emergency Planning and Community Right-to-Know Act (EPCRA) for the 2015 reporting year. Facilities that manufacture, process, or otherwise use Nonylphenols will be required to report release information on the chemical that occurred during 2015. The first report for Nonylphenol releases (if TRI threshold determinations are met) is due July 1, 2016.

New Reporting Requirement for 1-bromopropane for Reporting Year 2016

The EPA is also adding 1-bromopropane to the list of toxic chemicals subject to reporting under Section 313 (Toxics Release Inventory reporting) of the Emergency Planning and Community Right-to-Know Act (EPCRA). The first reports on 1-bromopropane releases will be due on July 1, 2017 for reporting year 2016.

The determination for adding this chemical to the reporting list is that the National Toxicology Program has been identified as the chemical to be “reasonably anticipated to be a human carcinogen.” 1-bromopropane is used as an aerosol solvent in asphalt, aircraft, and synthetic fiber manufacturing, as a vapor and immersion degreaser in metals, plastics, optics, and electronics manufacturing, and as a cleaning solvent for dry cleaning. The EPA had originally proposed this addition to the list in April 2015.

Getting it Right: TRI Risks and Pitfalls

Click here for several case studies illustrating the consequences of improper reporting. These companies have faced tens of thousands of dollars in fines, and in some extreme cases millions. Environmental Strategy Consultants has extensive experience and a proven track record in providing agency inspection ready documentation on threshold analyses, release calculations and reporting. Contact us for assistance with your reporting needs.

The EPA Heavily Inspects and Enforces the Toxic Release Inventory Reporting Program

The EPA has stepped up its inspection and enforcement of the TRI program in recent years, due to numerous facilities failing to submit timely, complete and correct TRI reports. The heaviest fines given by the EPA are mainly for failure to report a 313 chemical exceeding the threshold for reporting. Many facilities focus on just getting the report out and don’t spend the time needed on the threshold analysis. This often results in an incomplete threshold analysis and not identifying all the reportable 313’s at the facility. It is important for facilities to list each 313 chemical processed, used or manufactured onsite, including coincidentally manufactured chemicals.

The Program is Harder to Get Right Than it Appears

The threshold analysis can be more complex and time consuming than the actual report. Persistent Bioaccumulative Toxic (PBT) chemicals are often missed since they may be at levels not reported on SDSs or by suppliers and yet they are still subject to reporting. The thresholds for PBT’s are low. For example, mercury and mercury compounds have a reporting threshold of 10 lbs.

The Toxic Release Inventory Program is Complex

The EPA has over 30 guidance documents that contain special information on individual industries or chemicals. Many facilities do not realize that they have coincidentally manufactured chemicals. They are not reporting these as the EPA calls for in the guidance and looks for during inspections. Additionally, compounds, which sometimes are not listed on the SDSs, are often overlooked and misreported. Environmental Strategy Consultants, Inc. has insights and strategies for management of this critical regulation.

Form A can be the Achilles Heel

Erroneously filing Form A instead of Form R can lead to a fine for failure to report. The EPA considers this just as significant as not filing at all. The Form A “reportable amount” threshold must not be exceeded. The definition of the “reportable amount of 500 lbs.” is often misunderstood and thus many companies file a Form A instead of the Form R.

There are Many Exemptions and Qualifiers

Additionally, a thorough understanding of the reporting exemptions and chemical qualifiers is needed in order to ensure that the correct reports are submitted. Even facilities that are not required to submit reports but process, use or manufacture 313 chemicals are required to demonstrate non-applicability if audited.