TSCA and Exposure Assessment: Manufacturing + Unreasonable Risks - 58tinton.win

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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

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