Saturday, September 9, 2017

New manga markers!

For my birthday, I bought myself some new manga markers with the Amazon gift card my parents gave me. I am so excited to learn how to use them! I also bought some new manga paper to see how it differs from the multipurpose computer paper I usually use.

Things purchased:


Rather than be reasonable and practice in short sessions with the markers and paper, I dove in and recreated one of my favorite panels from my other favorite manga/anime: Vampire Knight. It turned out better than I anticipated, so I decided to post it as a new milestone in my mangaka journey.


Some notes:
  • Yup, I am aware the Day Class uniforms are black. At the moment, I only have a weird mix of primary colors and grays. No black marker in the set. So I improvised with blue! Same with Yuki's hair color, improvised with the sienna brown marker I have. 
  • Character names are Zero and Yuki, brought to you by the incredible Matsuri Hino
  • Therefore, this is fan art...while I try to figure out my own style. 
  • The paper I purchased does NOT let you erase once you have inked, so I'll be looking for a different long-term paper. Hence the pencil marks.

I hope you enjoy the new art, which will be posted sporadically as I find time on weekends between teaching, my doctorate studies, and life in general.

Yuki and Zero from Vampire Knight.

I anticipate that my own art and characters will be a hybrid of Hiromu Arakawa + Matsuri Hino + Hayao Miyazaki, since they are the artists I enjoy the most.  

Tuesday, September 5, 2017

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

Friday, August 18, 2017

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