On Volunteering and OHS Practice

Yo, it�s been a while. I can officially say that my second year as an academic was in no way easier than my first year, even though I had most of my classes already prepared. I found other things to fill the time I thought I would have � most of the things were some form of service or volunteering.

I spent the morning hand writing thank you cards (yes, I am someone who still does that!) to my guest speakers from winter and spring quarter, and was reflecting on how important volunteer work has been to my growth as an occupational health and safety (OHS) professional.

Back in 2010, when I was four years out of college and just getting a handle on my career, my local Arizona Chapter of the American Society of Safety Engineers (ASSE) had a Healthcare Section. The primary clients I served as an OHS consultant were healthcare facilities, so I started out as the Secretary of the Healthcare Section and then became the Chair. In this role, I learned how to use MailChimp, how to take decent meeting minutes, how to market our educational meetings to members and non-members, and had the opportunity to network with healthcare OHS professionals from all over the U.S.

After almost four years in that role, I switched my focus to volunteering with the Industrial Hygiene Practice Specialty (IHPS) of ASSE, starting as their Social Media and Website person, and moving into the Publications Chair role after a year or so. In my three years as Publications Chair (now called the Content Coordinator), I became proficient with LinkedIn networking, soliciting articles from members and non-members for our web-based publication, writing articles for the publication, editing submitted articles for the publication, and understanding the role of social media in OHS advocacy.

Within IHPS, I have served (officially and unofficially) in many roles, but my favorite role was Executive Secretary � it felt like I was at the heart of everything IHPS was doing. As Executive Secretary, I kept the minutes from our Volunteer Advisory Committee meetings and was able to help organize and participate in two free webinars (we call them �open calls�) for our membership, one on healthcare safety and another on hazardous drugs handling, spill clean-up and exposure assessment. I was also able to help with ASSE�s comments to NIOSH about the occupational exposure banding guidance.

Thanks to my involvement in IHPS, I was able to participate in the House of Delegates and Council on Practices and Standards (CoPS). I was also selected to speak at Safety 2016 in Atlanta and Safety 2017 in Denver. I don�t know if I would have been brave enough to submit a proposal to speak if I was not so involved in ASSE. Thanks to the local and regional events I spoke at in Arizona, I felt I was ready to take things to the next level.

In 2016, I took on an even more daunting role. After losing the election for Assistant Administrator for IHPS, I emailed ASSE staff and asked them which practice specialty needed help � where my efforts could do the most good. I ran for Assistant Administrator of the Training and Communications Practice Specialty (TCPS) and won. I take over as Administrator of TCPS in July 2018, which is pretty exciting.

In 2016, I also moved away from my Arizona ASSE Chapter, where I had many friends and contacts, to join Central Washington University (CWU). I became a member of the Puget Sound ASSE Chapter. Since their meetings are in the early mornings in downtown Seattle, I haven�t been able to attend due to my teaching schedule, but I spent the last two years on the Puget Sound ASSE Professional Development Conference (PDC) planning committee. Being part of the planning committee has helped me network with local OHS professionals, and I was lucky enough to co-present at this year's conference with the incredible Jeff Dalto of Convergence Training (recap and details here).

This year, I served as the Faculty Advisor for my CWU ASSE Student Section, helping them organize guest speakers, volunteer activities, and interest other CWU students in safety. We submitted an application for the Outstanding Student Section Award (OSSA) and were #3 out of 19 qualifying schools. We conducted a personal protective equipment (PPE) drive with CWU Safety and Health Management alumni from Mortenson, sending 3 packed boxes of PPE to the University of Puerto Rico to help with hurricane reconstruction efforts.

So, to sum up, this academic year I served ASSE in the following roles:

• Assistant Administrator of TCPS 
• Executive Secretary of IHPS for half the year, and now Professional Development Chair of IHPS 
• Puget Sound ASSE PDC planning committee 
• Faculty Advisor for CWU ASSE Student Section

In return for my volunteer efforts with ASSE, I have:

• Made lifelong friends who I love seeing at conferences 
• Built an impressive network of excellent OHS professionals 
• Improved my technical writing and editing skills 
• Become comfortable living part of my professional life online 
• Gained experience organizing seminars and conferences 
• Learned consensus building and conflict management 
• Had the opportunity to speak at local, regional, and national-level events 
• Been published in Professional Safety (March 2018 issue, useful summary here) 
• And much more! 

Why the long post sharing my experience volunteering for ASSE? I�ve been volunteering for 8 years now, and I�m looking forward to the next 8. Or 20, or however long my professional career in OHS lasts. I want to encourage the next generation to get involved with ASSE early in their career, like I did, and reap the personal and professional benefits.

All of the skills I obtained through my volunteer work have benefited my career.  If it hadn�t been for some careful nudging by my various mentors through the years, I might not have �put myself out there� and started volunteering.

The Industrious Hygienist is back and more determined than ever!

Will you answer the call? Will you share your experience and your expertise, and help build the future of OHS practice through advocacy and volunteer leadership? Or will you just watch it happen? #NextGenSafety #IndustriousHygienist #TalkSafetyWithUs

New Resource for Safety and Health Educators or Trainers

The course I am currently enrolled in for my EdD in Health Professions from A.T. Still University is EDUC 7500: Technology and Educational Transformation. As part of the course activities, I had to create an "interactive and informational" resource for tracking educational technology ideas, tools, and articles for an online undergraduate course I am revising about incident investigation and analysis.

I decided to complete this activity using Google+ Collections. "Safety Education & Training" is now a public collection of links, tools, ideas, and other activities associated with undergraduate and graduate safety education and workplace safety training.

Here's snapshot of how it looks:

The Industrious Hygienist's new "Safety Education and Training" Google+ Collection.

I'll be keeping the resource active and cross-posting useful information on this blog. Hopefully, I find some time to create some open educational resources (OERs) for occupational safety education, since there's not much out there except information from U.S. Occupational Safety and Health Administration, U.S. Chemical Safety Board, U.S. National Institute for Occupational Safety and Health, and the International Labour Organization.

Search of the OER Commons showed only a few resources related to occupational safety.

Two of the most interesting safety-related active learning items included in my collection are:

OSHA Hazard Identification Game
A safety hazard recognition game that is freely available to all employers and safety trainers for use.

Vivid Learning Systems
This group has 6 freely available interactive safety training practice exercises that safety students could learn from.

TSCA and Exposure Assessment: Risk Evaluation

This post is a continuation of the series on TSCA and exposure assessment. Today�s topic is risk evaluation, including the prioritization process for EPA.

15 CFR 53 Part 2605 explains how, once the U.S. Environmental Protection Agency (EPA) Administrator determines that a chemical substance or mixture presents a risk, the Administrator can apply one or more requirements to the substance.

The requirements can include:

• A prohibition or limitation restriction on manufacturing, processing, or distribution of the substance
• A prohibition or limitation on manufacturing, processing, or distribution of a substance for a particular use or concentration in excess of a level set by the Administrator
• A requirement for the substance or mixture to be marked with warnings and instructions with respect to use, distribution, and/or disposal � the form and content of these warnings is prescribed by the Administrator
• A requirement to maintain records associated with the manufacturing process and tests used to assure compliance with TSCA
• A requirement prohibiting or regulating any commercial use of a substance
• A requirement prohibiting or regulating any manner or method of disposal of a substance, or of any article containing the substance (applies to manufacturers, processors, and commercial use)

The EPA has released a risk-based screening process which will be explained in detail in a later post, but basically delineates chemical substances and mixtures as high-priority or low-priority. Only high-priority substances undergo risk evaluation at this time, and this is anticipated to a be a 3- to 3.5-year process. EPA must consider the hazard and exposure potential of the substance, including persistence and bioaccumulation, susceptible subpopulations, storage near drinking water sources, and whether there are conditions of use or volumes that are of concern.

A chemical substance submitted to EPA should have prioritization conducted within 9 months to 1 year. EPA will start with the chemical substances previously identified in the TSCA chemical work plan and then move on to other chemicals. EPA has 3.5 years to start conducting risk evaluations on 20 other high-priority substances, with preference given to chemicals on the 2014 update of the TSCA chemical work plan that are persistent, bioaccumulative, carcinogenic, or toxic (acute or chronic effects).

An interesting quote from 15 CFR 53 Part 2605 (b)(2)(c): �The Administrator shall continue to designate priority substances and conduct risk evaluations [�] at a pace consistent with the Administrator to complete risk evaluations [�]� (emphasis added). So, basically, EPA gets to set its own pace on this. 

Another interesting requirement is that risk evaluations of metals and metal compounds must use the Framework for Metals Risk Assessment of the EPA�s Office of the Science Advisor (2007) or its successor document.

The requirements for a risk evaluation are identified as:

• Integrate and assess available information on hazards and exposures for the conditions of use of the substance (considering risk of injury to health or the environment and susceptible subpopulations)
• Describe whether aggregate or sentinel exposures to a chemical substance under the conditions of use were considered, and the basis for that consideration
• Not consider costs or other non-risk factors
• Take into account the anticipated duration, intensity, frequency, and number of exposures under the conditions of use
• Describe the weight of scientific evidence for the identified hazard(s) and exposure(s)

�Aggregate� and �sentinel� exposures are not defined in the regulation. EPA further complicates this by using �aggregate� and �cumulative� in their website about exposure assessment tools being used.

• Aggregate = considers combined exposures to a single stressor across multiple routes and multiple pathways
• Cumulative = evaluates combined exposure to multiple stressors via multiple exposure pathways

The American Chemistry Council (ACC) had these same concerns in their response letter to EPA, recommending that EPA consider including �definitions of both aggregate and sentinel exposures in the proposed regulation so the regulated community will understand how EPA intends to apply the terms, and to ensure consistency and regularity in application.� ACC provided the following definitions for clarification:

• Aggregate = combined exposure for one substance over multiple exposure pathways from multiple difference sources (similar to definition given above)
• Sentinel = the exposure that is judged to cause the plausible upper-bound individual human exposure to a substance of interest within a broad category

When the EPA completes a risk evaluation, the Administrator should consider and publish a statement based on �reasonably available information� with respect to:

• Effects of the chemical substance on health and magnitude of exposure of human beings
• Effects of the chemical substance on the environment and magnitude of exposure of the environment
• Benefits of chemical substance (for various conditions of use)
• Reasonably ascertainable economic consequences of the rule, including the effect on the national economy, small business, technological innovation, the environment, and public health, as well as the costs/benefits of the regulatory action and the cost effectiveness of the regulatory action

This is seemingly contradictory, since the risk evaluation is supposed to be conducted without consideration of costs, but the final risk evaluation must consider costs and other economic consequences�it also requires the Administrator to consider if there are technically and economically feasible alternatives available before releasing a final rule on a substance.

In my next post, I�ll explain the risk evaluation process for TSCA. Future posts will include the following topics:

• Imminent hazards in TSCA
• Reporting requirements of TSCA
• Research aspects of TSCA
• How TSCA handles confidential information
• Citizen�s civil actions and petitions in TSCA
• Employee protection and TSCA effects on employment
• How test methods will be developed and evaluated for TSCA
• ReachScan: the exposure assessment model
• Using predictive methods to assess exposure 
• New chemical exposure limits under TSCA

TSCA and Exposure Assessment: Manufacturing + Unreasonable Risks

This post is a continuation of the series on TSCA and exposure assessment. Today�s topic is manufacturing and processing notices, including the requirement to protect against unreasonable risks.

15 CFR 53 Part 2604 discusses the general requirements for manufacturers and processors. In short, no person can manufacture a new chemical substance or manufacture a chemical substance for significant new use (as determined by the Administrator of the U.S. Environmental Protection Agency) without:

• Submitting an intention to manufacture or process the substance at least 90 days prior
• Waiting for the Administrator to make a review and determination of the substance
• Taking the actions required by the determination

How does the Administrator determine if use of a chemical substance is a significant new use? First, the Administrator receives the notification from the manufacturer or processor. Second, the Administrator considers all relevant factors. What are the �relevant factors� for consideration?

• Projected volume for manufacturing and processing
• Extent of change to exposure potential for human beings or the environment (a change in the type of exposure or the form of exposure)
• Extent of increase of exposure for human beings or the environment (a change in the magnitude or duration)
• Reasonably anticipated manner and methods of manufacturing, processing, distribution, and disposal

The Administrator will consider the factors listed above and determine:

• Whether the chemical substance or significant new use present an unreasonable risk of injury to health or the environment
• Whether the chemical substance or significant new use present an unreasonable risk to a potentially exposed or susceptible subpopulation
• Whether insufficient information exists to make a determination
• Whether the chemical substance or significant new use will be produced in substantial quantities
• Whether the chemical substance or significant new use may be reasonably anticipated to enter the environment in substantial quantities
• Whether the chemical substance or significant new use may cause significant or substantial human exposure to the substance

If the chemical substance or significant new use does NOT present an unreasonable risk according to the relevant factors, the manufacturer or processor can commence their activities.

Another word that is not defined in this regulation is �substantial� � What is a substantial quantity? What is a substantial exposure? What threshold quantity lists or exposure limits are being used to assess this? The information is not provided in the regulatory text (so far).

What happens to the information submitted by the manufacturer or processor? 2604(b)(3) states that any information submitted to the Administrator as part of an intent to manufacture or have a significant new use of a chemical substance �shall be made available [�] for examination by interested persons.� Such information, per Part 2613(a), does not include information that is exempt from disclosure (i.e., confidential information). However, if the manufacturer or processor mixes information that is protected from disclosure with information that is not protected from disclosure, it can be shared with interested persons upon request. Health and safety studies for products offered for commercial distribution and chemical substances or mixtures that the Administrator required testing and notification on are also not prohibited from disclosure.

Disclosure of formulas (including molecular structures), processes used in manufacturing or processing, or portions of mixtures are not part of this authorized disclosure process � these fall under the confidential information protection. However, manufacturing volumes or ranges or volumes are not prohibited from disclosure. General descriptions of a process �used in the manufacture or processing and industrial, commercial, or consumer functions and uses of a chemical substance, mixture, or article containing a chemical substance or mixture� are also not prohibited from disclosure.

Manufacturer and processor options for confidentiality claims are found in 2604(c), and every claim requires substantiation. An assertion of a confidentiality claim to the Administrator requires the following:

• The person has taken reasonable measures to protect the confidentiality of the information
• The person has determined that the information is not required to be disclosed under Federal law
• The person has a reasonable basis to conclude that disclosure of the information is likely to cause substantial harm to the competitive position of the person
• The person has a reasonable basis to believe the information is not readily discoverable through reverse engineering

The Administrator is responsible for developing guidance for the determination of �structurally descriptive generic names� when there are claims for protection from disclosure of specific chemical identities.

There are also exceptions to protection from disclosure. If disclosure of information is required for a specific Federal law enforcement purpose relating to protection of health or the environment, it must be disclosed to an officer or an employee of the U.S. upon request. If disclosure of information is required for satisfactory performance of a contractor for a contract with the U.S., it must be disclosed to a contractor of the U.S. and employees of that contractor.

The next part is a bit complicated, as it pertains to non-emergency disclosure of information, so I put it in a graphic form for simplification. 

TSCA Non-Emergency Disclosure of Information

In an emergency, the information will be provided to:

�A treating or responding physician, nurse, agent of a poison control center, public health or environmental official of a State, political subdivision of a State, or tribal government, or first responder (including any individual duly authorized by a Federal agency, State, political subdivision of a State, or tribal government who is trained in urgent medical care or other emergency procedures, including a police officer, firefighter, or emergency medical technician) if such person requests the information�

BUT, the person requesting the information in an emergency must have a reasonable basis to suspect that a medical, public health, or environmental emergency exists and the information is necessary for treatment of 1+ individuals

Part 2604(f) discusses how the Administrator will protect against unreasonable risks. The Administrator will determine if a chemical substance or significant new use presents an unreasonable risk of injury to health or the environment; this determination is conducted without consideration of costs or other nonrisk factors. If the chemical substance does pose an unreasonable risk, the Administrator can take action in several ways:

• Issue a proposed rule
• Limit the amount of a substance that can be manufactured, processed, or distributed
• Prohibit the manufacturing, processing, or distribution of a substance

There is one sneaky element of the regulation in 2604(f)(5) entitled �Workplace Exposures.� I have copied it below in its entirety.

�To the extent practicable, the Administrator shall consult with the Assistant Secretary of Labor for Occupational Safety and Health prior to adopting any prohibition or other restriction relating to a chemical substance with respect to which the Administrator has made a determination under subsection (a)(3)(A) or (B) to address workplace exposures.�

I�m curious about the language �to the extent practicable� and why the U.S. Environmental Protection Agency (EPA) Administrator is planning to make determinations to prohibit, restrict, or otherwise address workplace exposures, when this is the purview of the U.S. Occupational Safety and Health Administration (OSHA). The siloed nature of environmental (U.S. EPA), health (divided between U.S. EPA and OSHA and several other agencies), and safety (U.S. OSHA and several other agencies) regulations make it difficult for practitioners of occupational/environmental health and safety to fully understand compliance.

In my next post, I�ll explain the risk evaluation process for TSCA. Future posts will include the following topics:

• Risk evaluation in TSCA
• Imminent hazards in TSCA
• Reporting requirements of TSCA
• Research aspects of TSCA
• How TSCA handles confidential information
• Citizen�s civil actions and petitions in TSCA
• Employee protection and TSCA effects on employment
• How test methods will be developed and evaluated for TSCA
• ReachScan: the exposure assessment model
• Using predictive methods to assess exposure 
• New chemical exposure limits under TSCA

TSCA and Exposure Assessment: Testing Requirements

Continuing the series on TSCA and exposure assessment, today�s blog post is about the testing requirements for chemical substances in TSCA.

15 CFR 53 Part 2603(a) explains the testing requirements. This is best explained in a graphic (made by me and you're welcome to use it):

Flowchart of TSCA Testing Requirements

If a chemical fits the requirements explained in the image above, the Administrator (of the U.S. Environmental Protection Agency) will call for testing to be conducted on the substance or mixture. The testing must show whether the manufacture, distribution, processing, use, or disposal (or any combination of these activities) DOES or DOES NOT present an unreasonable risk of injury to health or the environment.

The Administrator can also require the development of new information relating to a chemical substance or mixture � this is at the discretion of the Administrator, to establish the priority (either high-priority or low-priority) of the substance or mixture. This prioritization is established to rank substances or mixtures for risk evaluation by the U.S. Environmental Protection Agency.

A high-priority substance is one that presents an unreasonable risk of injury to health or the environment because of a potential hazard or a potential route of exposure under normal conditions of use. The definition for high-priority substance has more worrisome language, however. The Administrator can conclude that a substance is a high-priority substance without consideration of costs or other non-risk factors, and the Administrator decides which potentially exposed or susceptible subpopulation is relevant in determining whether the substance poses an unreasonable risk (emphases added).

A low-priority substance is anything that the Administrator deems not to be a high-priority substance, based on information sufficient to establish this designation, without consideration of costs or other non-risk factors. �Information sufficient to establish� is not defined.

This puts a significant amount of authority on the Administrator - to decide which substances are high priority (or not), to decide which potentially exposed subpopulation is worth protecting, or what information and data is sufficient to establish the priority level. 

If the Administrator requires the development of new information, the Administrator must write a statement of need. This statement must include: 1) the need for the new information, 2) how information reasonably available to the Administrator was used to inform the decision, 3) explanation of any decision requiring the use of vertebrate animals for testing, and 4) why the issuance of an order is warranted rather than promulgating a rule or entering into a consent agreement.

One big issue here is �information reasonably available� to the Administrator � how is this to be decided? What constitutes reasonably available? How substantial of a data search or literature review is this?

Any rule, order, or consent agreement must include the following basic information:

• Identification of the chemical substance or mixture
• Protocols and methodologies for the development of information for each substance or mixture
• A specified time period (which may not be of unreasonable duration) where the person(s) required to conduct the testing must report the information to the Administrator

It also states the Administrator�s considerations for testing must include the relative costs of test protocols and methodologies, as well as the reasonably foreseeable availability of facilities and personnel needed to perform the testing under the rule. This may require the person(s) or facility to submit preliminary information to the Administrator.

Last post we discussed the health and environmental effects that would necessitate development of information � carcinogenesis, mutagenesis, teratogenesis, behavioral disorders, cumulative or synergistic effects, and any other effect that may present an unreasonable risk of injury to health or the environment.

The regulation also calls out specific characteristics of chemicals or substances that would necessitate development of information � persistence, acute toxicity, subacute toxicity, chronic toxicity, and any other characteristic that may present such a risk.

The inclusion of �any other characteristic� that may present an unreasonable risk is nonspecific and will likely present confusion for manufacturers in evaluating the risks of their substances or mixtures.

Protocols and methodologies that may be prescribed by the Administrator include epidemiologic studies, serial or tiered testing, in vitro tests, and whole animal tests. The regulation notes: �before prescribing epidemiologic studies of employees, the Administrator shall consult with the Director of the National Institute for Occupational Safety and Health� (NIOSH). This proposed practice may lead to privacy concerns for employees who may be required to participate in the epidemiological studies.

A goofy phrase in the regulation can be found in Part 2603(b)(2)(B), where it says: �from time to time, but not less than once each 12 months,� the Administrator must review any protocols or methodologies developed in response to a rule, order, or consent agreement for adequacy. This "from time to time" phrase makes no sense in a regulatory document. And again, the definition of �adequate� is not provided.

When creating the priority list, the Administrator has to consider at least the following information:

• The quantities of the substance that are or will be manufactured
• The quantities of the substance that are or will enter the environment
• The number of individuals that are or will be exposed to the substance in their place of employment, including the duration of such exposure
• The extent to which human beings are or will be exposed to the substance
• The extent to which the substance is closely related to another chemical substance which is known to present an unreasonable risk of injury to health or the environment
• The extent to which testing of the substance may result in the development of information upon which the effects of the substance on health or the environment can reasonably be determined
• The reasonably foreseeable availability of facilities and personnel for performing testing on the substance

The delineation of �individuals� that are or will be exposed in their place of employment versus �human beings� is unintentionally funny, as if individuals who work are somehow separate from the rest of humanity.

The regulation requires a committee to be established to make recommendations to the Administrator re: priority substances. The committee must give priority attention, per the regulation, to substances and mixtures that are carcinogens, mutagens, or teratogens. If the Administrator receives information about a substance that concludes the substance presents a significant risk of serious or widespread harm to human beings, the Administrator has 180-days to initiate �applicable action� to �prevent or reduce to a sufficient extent such risk.� 

Who decides what level of risk reduction is "sufficient" in this case? The words used in this regulation could easily be subject to interpretation an argument: unreasonable, sufficient, reasonably available, adequate, individuals, human beings, foreseeable, etc. 

Something interesting in the testing section is the requirement to reduce testing on vertebrates, and to use alternative testing methods whenever feasible. This can include:

• Computational toxicology and bioinformatics
• High throughput screening methods
• Testing of categories of chemical substances
• Tiered testing methods
• In vitro studies
• Systems biology
• Other new or revised methods identified by validation bodies

In my next post, I�ll go over the manufacturing section, including the requirement for �protection against unreasonable risks� per TSCA. Future posts will include the following topics:

• Manufacturing and protection against unreasonable risks
• Risk evaluation in TSCA
• Imminent hazards in TSCA
• Reporting requirements of TSCA
• Research aspects of TSCA
• How TSCA handles confidential information
• Citizen�s civil actions and petitions in TSCA
• Employee protection and TSCA effects on employment
• How test methods will be developed and evaluated for TSCA
• ReachScan: the exposure assessment model
• Using predictive methods to assess exposure 
• New chemical exposure limits under TSCA