(These comments have been submitted to the EPA amended TSCA docket regarding 1-BP and related solvents.)
We have reviewed rules and proposed rules for1-BP, MC, TCE, and PCE and are making suggestions to EPA as a possible win-win approach. The proposed rule for 1-BP (nPB), includes a number of interesting, innovative ideas that will make compliance and interpretation more accessible to the manufacturing community. We provide a number of suggestions to U.S. EPA that serve to harmonize final rules for the four solvents (1-BP, MC, TCE and PCE), codify the final rules in a single location, recognize the potential for catastrophic impact on patient and public safety of “regrettable substitution” and suggest EPA add Reduced Pressure Sealed Systems as a class of cleaning equipment with built-in engineering controls. While our comments and suggestions focus on issues related to vapor degreasing, some might be adaptable to other regulatory aspects.
Suggestion: Harmonize the final rules for MC, TCE, PCE, and1-BP (nPB)
As of September 22, 2024, while each rule or proposed rule represents a high level of thoughtful effort, very different and puzzling conclusions have been reached. Perhaps one or two EPA representatives for each solvent could form an overarching group to distill and build on the approach for each of the four solvents. Just as the ECEL for MC, TCE, PCE, and1-BP (nPB) would be consolidated into a single document (Proposed 1-BP rule, Unit I C (vi) ), consider issuing a single document for risk management for the four solvents. At the very least, change the wording for all four solvents so that in the final rules, the approach to risk management is similar.
Our wish is that each harmonized rule include the following
- Allow vapor degreasing – the ban for MC is arbitrary
- Emphasize and clarify the route of self-certification
- Recognize a category for Reduced Pressure, Sealed Systems (1) and include the proviso for other demonstrated technologies
- Because the criticality of cleaning depends on the end-use of the product being cleaned, included in each final rule, the four cleaning categories (General, Precision, Safety/Critical, and R&D) as defined in Section 7.7 of the Economic Analysis for 1-BP (proposed 1-BP rule: Unit IX Reference 3).
- Remove what appear to us to be arbitrary, unjustifiable exemptions and what might be perceived as special treatment for aerospace, NASA, and government facilities.
Suggestion: Provide mechanisms for those involved in safety/critical cleaning to continue to use validated, established technology. For that category, allow use of a worker exposure level such as Cal/OSHA or ACGIH as opposed to the ECEL.
As we explained in our August 2024 newsletter (2), Safety/Critical Cleaning is a category where, if the product is not cleaned appropriately, airplanes drop out of the sky and peoples tushies fall off. The risks associated with inadequate cleaning are unacceptable; product failure can result in multiple deaths or injuries. While the category Safety/Critical Cleaning appears in the economic analysis for 1-BP; we have not found mention in any of the final or proposed rules. The category must be recognized.
Safety/Critical Applications require extensive, time-consuming, costly validation and verification. Manufacturers balk at changing any cleaning process. For many medical devices, costs can run into the millions of dollars. 1-BP, TCE, MC, and PCE have similar molecular structures and therefor similar functions; moving from one to another is sometimes referred to as an “in-kind” substitution. A highly stringent regulatory restriction or a shortage brought on by those restrictions can force businesses to change to another solvent. While changes in Safety/Critical processes require process development and revalidation, there is less risk and, frankly less effort, for in-kind substitution than for moving to not in-kind substitution (using a very different molecule or blend). The regulations need to have similar language and to have to have similar requirements. It is unrealistic, risky and unnecessary to force manufacturers to interpret the differences between rule after complex rule. Harmonization is essential.
In addition to having EPA provide the option of self-certification for 1-BP and for the other three halogenated solvents for safety/critical applications, we strongly suggest that for this Safety/Critical category, EPA allow a worker exposure level that has been relatively recently established by an agency or group like Cal/OSHA (DOSH) or ACGIH. For safety/critical applications, the risk of adopting a cleaning agent or process that has not been thoroughly tested needs to include risks to the public of product failure as well as the risks of worker, ONU and neighborhood exposure.
These suggestions are analogous to the way the category of “precision cleaning” allows for more acceptable options under the EPA Significant New Alternatives Policy (SNAP) Program. The Safety/Critical category should be designed so as not to pressure or even encourage business to change processes without complete revalidation and testing. Unless it can be shown that the combined risk, including that from product failure, is not increased by requiring an alternative process, an established albeit higher exposure limit should be allowed to continue. This option is important for manufacturers upstream in the supply chain as well as final assembly.
Suggestion: Recognize and foster the use of reduced pressure, sealed systems
What we have termed ‘reduced pressure, sealed systems’ are a cleaning technology that includes engineering controls to minimize air emissions and worker exposure (1). We suggest that such systems be recognized and included in each rule as a specific category. Terms like closed loop or airless do not describe the technology and can be misconstrued. Wording could be included to encourage development of this and other effective cleaning systems that reduce emissions to acceptable levels.
Details
The 1-BP rule recognizes either open-top degreasers (OTVD) or “closed loop batch vapor degreasers.” The term “closed loop” does not accurately or unambiguously describe a category of cleaning machine that minimizes both air emissions and worker exposure. The term can be mis-interpreted to include systems that redistill the solvent for re-use but do not necessarily reduce emissions to near zero. In contrast with open top degreasers, in a reduced pressure sealed system, there is no interface between the cleaning solvent and air when parts are introduced to or removed from the cleaning chamber. Solvent is not introduced into the cleaning chamber until the chamber has been closed, sealed and the internal pressure has been reduced. The chamber is not re-opened until solvent has been removed from the chamber, returned to storage container(s) and the cleaned product is dry. Final trace solvent residue can be captured in carbon.
Section 7.7 of the Economic Analysis for 1-BP includes the costs of replacing an OTVD using 1-BP with an airless degreaser containing PCE. The analysis does not include the option to use an airless degreaser containing 1-BP.
We suggest the term “airless degreaser” be replaced by “Reduced Pressure, Sealed System.” The term ‘airless’ relates to SCAQMD rules developed during the mid-1990s.
Airless is neither descriptive nor accurate; the cleaning systems do not achieve a true “airless” state. They provide containment by being sealed and operating at a reduced pressure, not necessarily a hard vacuum.
Notes:
A – These comments expand on “Survival of the Fittest, Critical Cleaning, and EPA Amended TSCA Rules – Coping with Change,” originally published in “Clean Source, The Official Journal of the Cleaning Lady and the Rocket Scientist” August 2024 (1). The article was submitted to this docket on 9/21/2024. The comments and suggestions also draw from “Understand and Address the Regulatory Landscape–(Survival tactics for effective product cleaning & manufacturing),” presented by Ed Kanegsberg at the Parts Cleaning Conference (PPC) in Chicago, Sept 10, 2024.
B – Our comments and suggestions are based on the conviction that, for sustainable regulations, it is essential to optimize worker safety, achieve environmental protection, maintain product quality, and support U.S. manufacturing. Our clients include manufacturers of product and components, the military, government (including the U.S EPA), as well as providers and advocates of cleaning chemicals and cleaning processes. Our three decades of working with our clients inform our viewpoint. That said, our opinions are our own; and we have not used client funding for this article/submission.
References and links:
- B. Kanegsberg and E. Kanegsberg, “Survival of the Fittest, Critical Cleaning, and EPA Amended TSCA Rules – Coping with Change,” Clean Source, The Official Journal of the Cleaning Lady and the Rocket Scientist, August 2024, https://bfksolutions.com/survival-of-the-fittest-critical-cleaning-and-epa-amended-tsca-rules-coping-with-change/
- B. Kanegsberg and E. Kanegsberg, “Degreasers”, Clean Source, The Official Journal of the Cleaning Lady and the Rocket Scientist, January, 2024, https://bfksolutions.com/degreasers/
Contacts:
Barbara Kanegsberg: barbara@bfksolutions.com
Ed Kanegsberg: ed@bfksolutions.com
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