The Future of Manufacturing – Regulations, Restrictions, Maybe Bans

Read this if you use free-range, cage-free cleaning agents to clean products during manufacturing. Read this if you clean with halogenated solvents. Even if you don’t use halogenated solvents, there is a good chance that the performance of your current cleaning processes depends on manufacturers in your supply chain who do use halogenated solvents. Developing U.S. EPA regulations, based on a law that was passed with bi-partisan support, could highly restrict or even ban those solvents. Actions that could lead to regulations impacting trichloroethylene, n-propyl bromide, perchloroethylene, and methylene chloride are well underway, and action has started to evaluate trans-1,2-dichloroethylene (trans-DCE). Read on to learn what’s happening on the regulatory front. Read on for perspectives to respond, adapt, and stay productive. It is a big topic! Call us to discuss details, and what you can do.

A note from The Cleaning Lady: Regulatory reports can be complex. Terms and acronyms can be mystifying to non-governmental folks. For example, I have to remind myself that TSCA is not an opera with high-decibel sound and flamboyant costumes. TSCA stands for the Toxic Substances Control Act. This article represents our best effort at interpreting governmental/regulatory documents and conveying relevant information to the manufacturing community.

Cleaning with halogenated solvents is efficient and economic. Halogenated solvents work well, especially for removing adherent soils and accessing areas like blind holes. However, halogenated solvents have been under scrutiny due to health risks from exposure.

Four years ago (June 22, 2016), the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Chemical Safety Act) became law. This law amends the Toxic Substances Control Act (TSCA) and tasks the US EPA to reduce environmental and health risks from chemicals used in the workplace.

The TSCA evaluation process consists of three primary steps, Prioritization, Risk Evaluation, and Risk Management (1).

The EPA identified several halogenated cleaning solvents as high-priority and are moving through or beyond the risk evaluation stage. When EPA evaluates risks, they look at exposure and risk to people being exposed to the chemical; they do not address other factors including costs (1). Risk management can include cost considerations.

Summary: Halogenated Solvents under TSCA Reform (2)

Chemical

CAS (Chemical ID number)

Status, Reports

Methylene Chloride (MC)

75-09-2

Risk eval. complete (3)

1-Bromopropane (1-Bp, nPB)

106-94-5

Draft risk evaluation (4)

Trichloroethylene (TCE)

79-01-6

Draft risk evaluation (5)

Perchloroethylene (PCE)

127-1

Draft risk evaluation (6)

Trans-1,2-Dichloroethylene (DCE)

156-60-5

Draft scope (7)

Methylene chloride
In April, EPA published the final risk evaluation for methylene chloride, which found unreasonable risks (3). Within a year, they must address these unreasonable risks and take public comments on any proposed actions. By the way, EPA has already taken action on consumer uses of MC. As of November 22, 2019, MC was banned from sales for consumer use as a paint remover and consumers who have such products are encouraged to stop using them.

nPB, TCE, PCE
EPA issued a draft risk assessment for 1-Bromopropane (4). Many manufacturers know this solvent either by a trade name or as n-Propyl Bromide (nPB). Action is underway to complete a final risk evaluation as well as an economic assessment of alternative processes. Draft risk assessments have also been published for TCE (5), and PCE (6); final assessments will probably follow that for nPB.

trans-DCE
trans-DCE is commonly used in solvent blends for aerosol and vapor degreasing applications. Because it is flammable, it is typically blended with an HFC, HFE or HFO to suppress the flammability. In many or most cases, trans-DCE is the work horse in the blend; it has the strongest solvency parameters for manufacturing fluids (e.g. oils, greases, cutting lubricants). EPA published a draft scope in April (7), the first step in risk evaluation.

What might the EPA do?
When the EPA finds there to be an unreasonable risk to workers, including to those in proximity but not in direct contact with the chemical, they can take any of a number of actions. Possible actions include), mandating use of Personnel Protection Equipment (PPE), such as a respirator, or requiring vapor degreasing equipment to be fully enclosed (airtight or vacuum).

The EPA could also ban the chemical, either totally or partially (eg. aerosols or consumer products).

What does this mean for manufacturers?
It depends on how each cleaning agent is handled by the EPA. If all of the above solvents were to be highly-restricted or banned, there would be a tremendous level of upheaval in the world of manufacturing. Without proper planning and testing, critical cleaning of high value product and therefore the performance of high value product could be compromised. “Compromised” is a polite way of saying that there could be a danger to public and patient safety.

Very well-contained equipment, like airless systems, cost money. Some manufacturers, including some of our clients, find airless systems actually improve process consistency and productivity.

You can’t assume that any substitute is a “drop-in.” Even switching from one halogenated solvent to another means planning and testing. However, the more a chemical differs from the one you were using, the more indigestion is involved. Some aspects of indigestion include: planning, testing, equipment purchases, communication with customers and suppliers, validation, verification.

All chemicals and processes have potential safety and environmental baggage, and if manufacturers adopt substitute chemicals and processes without the right controls, there can be other worker safety issues (eg. flammability, toxicity).

What can you do?
Be strategic! Figure out where your business, your production flow, might be vulnerable. Decide where communication is in order.

  • Where do you use halogenated solvents?
  • Where does your supply chain use halogenated solvents?
  • Should you communicate directly with the EPA?

On this last point, you might, for example, want to quantify and document processes with very low solvent losses. Your company might then want to communicate those findings with the EPA. Doing so could keep your favorite cleaning processes available. Of course, we don’t know all of the regulatory issues your company might be involved in, so please coordinate with the appropriate departments and advisors.

For Pete’s sake, don’t wait till the last minute!
Manufacturers who wait for a deadline, who react rather than explore options, will find themselves in an uncompetitive position.

References

1. https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-evaluations-existing-chemicals-under-tsca

2. https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/chemicals-undergoing-risk-evaluation-under-tsca

3. https://www.epa.gov/sites/production/files/2020-06/documents/1_mecl_risk_evaluation_final.pdf

4. https://www.epa.gov/sites/production/files/2019-08/documents/01._1-bp_draft_risk_evaluation_hero_links_external.pdf

5. https://www.epa.gov/sites/production/files/2020-02/documents/1_draft_risk_evaluation_for_trichloroethylene_tce_public.pdf

6. https://www.epa.gov/sites/production/files/2020-04/documents/draft_risk_evaluation_for_perchloroethylene_public.pdf

7. https://www.epa.gov/sites/production/files/2020-04/documents/casrn-156-60-5_trans-12-dichloroethylene_draft_scope.pdf

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