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

Understanding Risk Assessment & Management - Video

I found this video about understanding the difference between hazard and risk, and the process of risk assessment. It covers the basics and looks to be a decent resource to use in my classroom. 

TSCA and Exposure Assessment: Overview

While I was revising my SHM 477: Environmental Management course for the next academic year, I found myself overwhelmed by the volume of information about the changes to the Toxic Substances Control Act (TSCA). There is a slew of information out there, most of it by the U.S. Environmental Protection Agency, but it is strangely structured and not all of it is user-friendly. Hence, this post and the series that will follow on TSCA.

The revised regulations for Toxic Substances Control are found in Chapter 53 of Title 15, and the text of the new requirements is in Subchapter I, “Control of Toxic Substances.” 

15 CFR 53 Part 2601(a) explains the focus of Subchapter I, “Control of Toxic Substances,” to be on chemical substances and mixtures that are manufactured, processed, distributed in commerce, used, or disposed, and which “may present an unreasonable risk of injury to health or the environment.”

“Unreasonable” is the key word here, and it is not defined. All the regulation says is that the Administrator (of the U.S. Environmental Protection Agency) will determine whether a chemical poses an unreasonable risk based on scientific information or testing. In Part 2603(b), it expounds upon what could be considered an unreasonable risk: health and environmental effects including carcinogenesis, mutagenesis, teratogenesis, behavioral disorders, cumulative or synergistic effects, and any other effect that could present an unreasonable risk of injury to health or the environment.

By this definition, were you to bottle sunlight as a new chemical product, it could easily constitute an unreasonable risk, due to the ultraviolet radiation and potential for cancer.

This regulation puts into policy a requirement for the development of adequate information about the health and environmental effects of chemical substances and mixtures, and places the responsibility for developing this information on the manufacturers and processors of chemical substances and mixtures per 15 CFR 53 Part 2601 (b)(1).

The key word in this section is “adequate” – who decides whether the information provided by a manufacturer is adequate? How do they think manufacturers and distributors will find the funding, technical specialists, and content experts to develop this information? Many manufacturers are still not in compliance with the 29 CFR 1910 Part 1200 Hazard Communication requirements – many Safety Data Sheets (SDS) in circulation today do not meet the requirements or intent of the standard.

The Administrator (of the U.S. Environmental Protection Agency) is responsible for considering the environmental, economic, and social impacts of actions associated with TSCA. This is a strange statement, and puts the Administrator and the U.S. Environmental Protection Agency in an unenviable position of trying to please everybody.

Some interesting definitions for industrial hygienists and safety professionals to consider:

• “Conditions of use” means the circumstances […] under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of.
• “Environment” includes water, air, and land and the interrelationship which exists among and between water, air, and land and all living things.
• “Health and safety study” means any study of any effect of a chemical substance or mixture on health or the environment or on both, including underlying information and epidemiological studies, studies of occupational exposure to a chemical substance or mixture, toxicological, clinical, and ecological studies of a chemical substance or mixture, and any test performed pursuant to this chapter.
• “Potentially exposed or susceptible subpopulation” means a group of individuals within the general population […] who, due to either greater susceptibility or greater exposure, may be at greater risk than the general population of adverse health effects from exposure to a chemical substance or mixture, such as infants, children, pregnant women, workers, or the elderly.

One item of concern is the definition of “health and safety study” – it does not seem to require that the stud(ies) be peer-reviewed to be used, per the definition. Does this mean the U.S. EPA is encouraging and will support citizen science? How will the submitted studies be evaluated for scientific accuracy and validity?

Part 2625(h), “Scientific Standards” provides some clarification:

• The Administrator will make a decision based on science (always a good thing)
• The Administrator will use scientific information, technical procedures, measures, methods, protocols, methodologies, or models […] consistent with the best available science
• The Administrator will consider the extent to which the scientific information, technical procedures, measures, methods, protocols, methodologies, or models are REASONABLE, CONSISTENT with, and RELEVANT for the intended use of the information
• The data, assumptions, methods, quality assurance, and analyses employed must be documented and will be evaluated for clarity and completeness
• The variability and uncertainty of the procedures, measures, methods, protocols, methodologies, or models will be evaluated and characterized
• The “extent of independent verification or peer review” for the procedures, measures, protocols, methodologies, or models will be evaluated
• The Administrator will make decisions based on the “weight of the scientific evidence”

This language is troublesome and does not appear to require peer reviewed science. As William Watt said: “Do not put your faith in what statistics say until you have carefully considered what they do not say.” Results can be manipulated using complex statistical analyses until they say (or do not say) whatever the authors’ hypothesis may have been.

Simon Oxenham at Big Think (#bigthink) explored this in an article entitled “Believe It Or Not, Most Published Research Findings Are Probably False.” He gave a quick synopsis of key things for scientists to consider:

• The smaller the study, the less likely the findings are to be true.
• The smaller the effect size, the less likely the findings are to be true.
• The greater the number and the lesser the selection of tested relationships, the less likely the findings are to be true.
• The greater the financial and other interests and prejudices, the less likely the findings are to be true.
• The hotter a scientific field, the less likely the findings are to be true.

The last two points are especially worrisome for the state of exposure assessment today – there are significant costs associated with determining the exposure concerns for TSCA, and there is a lot of money involved in developing newer, faster, and more specialized tests for chemicals. There is such potential for bias and lazy or incomplete science with the explosion of interest in occupational and exposure science, and recognizing this seems to be up to each individual industrial hygienist or safety professional.

A similar concept was explored by Derek Muller at Veritasium (#veritasium) in a video entitled “Is Most Published Research Wrong?” It’s a good video to watch if you’re too busy to read the Big Think article.

In my next post, I’ll go over the testing requirement for chemical substances per TSCA. Future posts are planned to include the following topics:

• Testing of chemical substances
• 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