150 Barbara Kanegsberg 16924 Livorno Dr., Pacific Palisades, CA 90272 (310) 459-3614 • fax (310) 459-3624 Barbara@Bfksolutions.com • www.Bfksolutions.com Barbara Kanegsberg, President Ed Kanegsberg, Vice President DATE: March 13, 2011 TO: Gene Pettingill State of Delaware Department of Natural Resources and Environmental Control gene.pettingill@state.de.us FROM: Barbara Kanegsberg Ed Kanegsberg SUBJECT: Comments, Stakeholder Review Draft 082710B GMP, OTC Model Rule for Solvent Degreasing 2011 Table of Contents 1 Summary ....................................................................................................................... 2 2 Definition of solvent ..................................................................................................... 2 3 Cleaning agent options .................................................................................................. 2 3.1 Aqueous cleaning options ...................................................................................... 3 4 Exemptions ................................................................................................................... 4 4.1 Process control option for high-value products ..................................................... 4 4.2 Example, inapplicable exemption .......................................................................... 5 4.3 Management of VOC-exempt NESHAP Solvents ................................................ 5 5 Cleaning equipment ...................................................................................................... 5 5.1 Suggest changing Airless/Airtight to: Qualified Contained Cleaning System ...... 5 5.1.1 Proviso: Aqueous Cleaning Systems .............................................................. 6 5.2 Remove “vacuum” from the definition of airless/airtight...................................... 6 5.3 Background: airless/airtight systems ..................................................................... 6 5.3.1 Historical perspective, rule development ........................................................ 6 5.3.2 Airless System Performance ........................................................................... 7 5.3.3 Additional equipment options are essential .................................................... 7 5.4 Encourage “NESHAP-like” controls and solvent monitoring for high-value processes. ........................................................................................................................ 7 6 Appendices .................................................................................................................... 7 6.1 References .............................................................................................................. 7 6.2 Qualifications of BFK Solutions LLC ................................................................... 8 Kanegsberg comments to OTC 1 1 Summary As we discussed recently, we understand the urgency to obtain improved air quality throughout the Ozone Transport Commission (OTC) region. We appreciate the opportunity to comment on this impressive project. We have provided some suggestions to build on the California approach, particularly those portions of the OTC Model Rule for Solvent Degreasing 2011 that have been adapted or transcribed from SCAQMD Rule 1122. Our rationale is to help the OTC develop a scientifically-based, transparent, and defensible model rule that can be adopted or adapted to individual state requirements. The model rule in its current format calls for an upper limit of 25 g/L VOC content for cleaning agents and adopts the airless/airtight cleaning system definition from SCAQMD Rule 1122. Exemption categories also appear to follow the wording used in Rule 1122. We suggest that the rule be modified in terms of the solvent options available, the description of acceptable cleaning equipment, and the nature of exemptions. We also suggest approaches to making the Model Rule more holistic and to avoid unintended consequences. Specifically, Rule 1122 also deals with control of NESHAP solvents, and we strongly suggest that, without countermanding Congressional action, you honor the intent of that action and protect communities and workers by building on Rule 1122. There may be an understandable presumption that if there were complaints in the SCAQMD area, you would have heard them. You may not have heard the complaints. We have. Industry continues to exit the area. Rule 1122 has left the manufacturing remaining in Southern California with few if any options for critical cleaning applications. Our suggestions are geared to designing a realistic, holistic model rule, one that is protective of the environment, neighborhoods, and workers. 2 Definition of solvent We suggest that a description covering solvent, or cleaning solvent, or cleaning agent be added to the definitions section. Based on informal discussions, there appears to be some confusion as to whether or not the model rule is meant to cover aqueous blends or microemulsions as opposed to unblended solvents and solvent blends. Many cleaning agents that are marketed as aqueous may contain significant levels of VOCs. 3 Cleaning agent options An upper limit of 25 g/L VOC content does not provide adequate cleaning agents for manufacturing. With few exceptions, the available solvents that have been declared negligibly reactive at the Federal level are not sufficiently aggressive against soils of interest. Many are used as carriers and/or to inert more effective, but often flammable, VOC solvents. In some cases, the blends or azeotropes are predominantly VOCs. 150 g/L with reasonable containment during the process would be a realistic achievable goal for cleaning agents. Further, fostering the use of solvents with an exceedingly low vapor Kanegsberg comments to OTC 2 pressure as a discriminator is very often not a technically acceptable approach. Such cleaning agents often require extensive rinsing to avoid unacceptable surface residue. Depending on the few VOC-exempt compounds that are available is unrealistic. One of the few VOC-exempt chemicals that are useful in cleaning applications, HCFC 225, is an ozone depleting compound (ODC) and will be phased out of production on January 1, 2015. HCFC 225 has low to moderate solvency and is sometimes blended with VOCs. It is not clear that local California industry has a readily available replacement. Acetone is also used extensively in the SCAQMD area. Many aerosol products have been reformulated to contain acetone along with a small amount of a VOC; the VOC is actually doing the job. Acetone evaporates exceedingly rapidly; therefore, a great deal is emitted to the environment. It is reasonable to expect that emitting large amounts of a compound, even one with low, but not zero, relative reactivity, will have a negative impact on air quality. In addition, with the change to acetone comes potential safety issues due to the exceedingly low flashpoint of acetone and, in some cases, also with issues of potential unanticipated worker exposure problems of blended of acetone-based blended products (1) 3.1 Aqueous cleaning options Well-designed aqueous cleaning processes are appropriate and successful for many applications. At the same time, there are recurrent, erroneous assertions that aqueous cleaning agents will solve all environmental, safety, and manufacturing problems and that effective aqueous cleaning agents containing ever-decreasing levels of VOCs can be formulated. Formulations with less than a 25 g/L VOC content often do not perform well for critical manufacturing applications. A leading formulator and supplier of aqueous cleaning agents for electronics assemblers estimates that 150 g/L VOC as applied is typical of what is needed to deflux (clean) today’s densely-populated, closely-spaced electronics assemblies. While we have not done a complete survey of suppliers of cleaning agents, the 150 g/L VOC level seems realistic. (By the way, it is essential to list the VOC level “as applied” or “as used,” so that cleaning chemistries can be shipped in concentrated form.) Regulatory edict cannot change technical reality. While cleaning can sometimes be avoided and while water alone can be used in some applications, using very low VOC aqueous cleaning agents is impractical and ineffective in many instances. The wetting capability and solvency properties are not sufficient for removal of soil from ornate parts or closely-spaced components. Very high cleaning forces, high temperatures, and long cleaning times are required. If we consider the steps in the cleaning process to consist of wash, rinse, and dry, using very low VOC aqueous cleaners often involves strong forces such as high pressure spray and/or ultrasonics. These forces, heat, and time tend to increase emissions, not to mention the higher worker exposure to process chemicals and higher energy usage. Rinsing is generally needed to remove cleaning agent residue; this results in more air emissions and uses additional energy. The drying step involves still Kanegsberg comments to OTC 3 additional significant energy usage. The rework and reject rate for ineffective processes leads to even more environmental, safety, and economic problems. The 25 g/L VOC limitation means that many aqueous cleaning chemistries can no longer be used in the SCAQMD area. This has had an impact on Southern California industry. Manufacturers that remain in the SCAQMD area are often so constricted in chemistries that can be used that they can accept only a subset of potential projects. For example, an electronics assembler chooses only those that can be accomplished with no significant use of cleaning chemistry. “Some contract manufacturers are understandably sensitive to the limitations in their process options. For example, one group, that asks not to be identified, looks for projects that can be completed successfully with technology that can be readily adopted in a stringent regulatory climate. They clean with deionized water, not with surfactants or other cleaning chemicals; they select applications that use water soluble fluxes. (2)” 4 Exemptions We suggest you make the exemptions more general than they are, rather than copy the SCAQMD wording. We suggest that the Model Rule simply list some of potential exemptions that individual states might want to expand on. Transcribing process or product exemptions that are found in Southern California regulations is not a reasonable approach. Based on our recollection, most of those exemptions were developed 10 to 15 years ago and represent the results of efforts by advocates and companies. Attempts were made to address manufacturing issues of the day and to enable some companies to meet then-current contracts. These exemptions are not necessarily appropriate to the current needs of East Coast companies. Based on interchanges with clients and colleagues in the OTC region, many manufacturing operations could be reasonably classified as critical cleaning or cleaning of high-value product, not general cleaning. A great deal of the non-critical cleaning has moved overseas. Therefore, most might be able to present valid reasons for individual exemption from State rules; and they would be likely to do so rather than attempt to comply with very costly regulations. Another concern we have is that under Rule 1122, a manufacturing facility would have to be completely devoted to the exempt process in order to obtain an exemption. Many companies are either job shops or they have diversified product lines; some of those products might be for exempt categories, others might not. This is a difficult problem. We do not have all of the answers. Requiring two production lines may be possible for some manufacturers; but it may be onerous and unachievable for small companies with limited space and limited financial resources. For such manufacturing facilities, perhaps cleaning systems such as are discussed in section 5.4 might be appropriate. 4.1 Process control option for high-value products For those applications that could justify an exemption, VOC reduction could still be achieved by requiring emission controls equivalent to those for NESHAP solvents. This Kanegsberg comments to OTC 4 would avoid an all-or-nothing approach that could allow manufacturers claim a need for exemption and then to use highly emissive processes. Please refer to Section 5.4 4.2 Example, inapplicable exemption Film processing is an example of where simply excising portions of SCAQMD rules is not an appropriate extrapolation. A wholesale exemption of the processing of motion picture film would seem inappropriate in an overall model rule, especially one geared for areas outside of Southern California. The use of digital media has increased. Where chemical processing is required, many companies use VOC exempt compounds that are not hazardous air pollutants combined with very powerful ultrasonics have been found to provide acceptable cleaning results. “Wet gate processing” uses perchloroethylene (PCE) to print film and to transcribe film to other media; and some companies still use PCE for cleaning. PCE is important for wet gate processing because of its unique optical properties. However, PCE is also VOC exempt. The OTC Model Rule is exempting a category that largely uses VOC-exempt compounds. 4.3 Management of VOC-exempt NESHAP Solvents We must emphasize that the use of PCE needs to by addressed by the OTC; it is apparently not covered in the current model rule. The SCAQMD rule is more holistic in that it specifically includes the use of all NESHAP solvents, exempt and non-exempt. Under the Model Rule, PCE and methylene chloride (MC) could be used in a more emissive manner than could relatively benign VOC solvents and many aqueous VOC blends. We understand that Congress has chartered the OTC to take steps that should decrease the level of tropospheric ozone. However, a more holistic model rule, one that could be more readily-adapted by individual states, could be developed without countermanding instructions from Congress. Perhaps discussion of controls for VOCexempt NESHAP solvents could be worded as suggestions or reminders. This is important, particularly given the strong influence of Rule 1122. 5 Cleaning equipment 5.1 Suggest changing Airless/Airtight to: Qualified Contained Cleaning System Wherever the term “airless/airtight” is used is used in the Model Rule, except in the wording of the definition of airless/airtight itself, we suggest that the Rule refer to “Qualified Contained Cleaning Systems.” A definition should be added for a “Qualified Contained Cleaning Systems”. This new definition could read: “Qualified Contained Cleaning Systems” means an airless, airtight system or any other system to be used with high-VOC cleaning agents. Such systems must meet the definition of a Permanent Enclosure (PE) by EPA Method 204 or operationally meet emission standards for a Temporary Total Enclosure (TTE) criteria per EPA Methods 204 Kanegsberg comments to OTC 5 through 204F or per SCAQMD “Protocol for Determination of Volatile Organic Compounds (VOC) Capture Efficiency.” There must be sufficient public disclosure of the design to show that a system meets standards for PE. Alternatively, there must be sufficient public disclosure of data to demonstrate that the system meets the requirements for a TTE. Suppliers of an airless, airtight system or any other system for high-VOC processes would then have to demonstrate that the design meets the definition of a PE or a TTE. Such a definition would be more appropriate and inclusive than that of airless/airtight. Even more important, manufacturers of all cleaning systems to be classified as a “Qualified Contained Cleaning Systems” should be required to provide third party, published, publicly-available data and/or pertinent supporting information. 5.1.1 Proviso: Aqueous Cleaning Systems Depending on the VOC limits that are set, aqueous systems may or may not meet the EPA Methods or SCAQMD Protocol and may require alternative approaches to VOC control. Time does not permit us to fully discuss issues of aqueous cleaning systems. 5.2 Remove “vacuum” from the definition of airless/airtight Airless and airtight systems are a subset of what we have redefined as “Qualified Cleaning Systems.” However, the word “vacuum” should be removed from the phrase “vacuum drying.” The reason is that many if not most airtight systems do not and/or cannot use vacuum drying. Further, we consider the use of the term vacuum to be a misnomer. It would be more appropriate to use the term “reduced pressure” rather than “airless” systems. Many of these cleaning systems may meet the definition of a Permanent Total Enclosure in EPA Method 204. 5.3 Background: airless/airtight systems 5.3.1 Historical perspective, rule development The current definition of airless/airtight was added to SCAQMD Rule 1122 approximately a decade ago based on input from some equipment manufacturers. However, this input was clearly not comprehensive. Based on our records of iterations of Rule 1122, the concept of “vacuum drying” was not inserted until the final iteration of the 2001 rulemaking amendment process. We consider that including “vacuum drying” in the definition to be counterproductive to the development and adoption of valid, nonemissive cleaning equipment. For example, drying can be accomplished by “pushing” the solvent off of the product rather than by “pulling” it off at reduced pressure. Additional valid approaches to containment are available and still more may be developed. Kanegsberg comments to OTC 6 While the definition of “airless/airtight” was adopted in the 2001 version of Rule 1122; the reference to EPA Method 204 test methods did not occur until a subsequent revision, even though EPA Method 204 appears to have been available since the mid-1990’s. 5.3.2 Airless System Performance Airless systems are viable options. Based on pragmatic experience with individual clients, many “airless” systems do an excellent job of solvent containment. We have communicated experiences of manufacturers in presentations and publications; we have also outlined one case study in our “Handbook for Critical Cleaning;” and a chapter is devoted to such systems (3). However, airless systems require a substantial capital investment; they have a large footprint; proper operation involves up-front and on-going employee education; and they require significantly more upkeep than a standard open top system. Airless systems can be a good answer; they are not the only answer. 5.3.3 Additional equipment options are essential It is important to provide the option to use cleaning technologies other than airless systems, even though they are largely excluded from use in the SCAQMD area. The technical rationale for this exclusion eludes us. It should also be noted that, “airless” or “vacuum” systems cannot be used with all solvents or in all cleaning processes. Many reputable equipment manufacturers consider low flashpoint solvents to be incompatible with “airless” systems. In addition, high frequency (over 100 KHz) ultrasonic cleaning is used for more and more manufacturing processes; these designs require a reduced tank wall thickness. The decreased thickness of the tank wall makes it impractical to use reduced pressure with higher frequency ultrasonics. 5.4 Encourage “NESHAP-like” controls and solvent monitoring for high-value processes. Examples of high value applications include military, aeronautics, medical, and micro components or products. Rather than provide a blanket exemption for such high-value applications, it seems more productive for a model rule to encourage “NESHAP-like” cleaning equipment along with solvent monitoring. Such a tactic would allow industry to use effective cleaning agents and would provide greater flexibility in permitting. 6 Appendices 6.1 References (1) R. Harrison et. al., Morbidity and Mortality Weekly Report, Center for Disease Control, Vol. 50, No. 45, p 1011, 2001. Kanegsberg comments to OTC 7 (2) Kanegsberg, B. and E. Kanegsberg, “Southern California Defluxing – Learning Locally, Manufacturing Globally, PLUS, October, 2010. (3) Kanegsberg, B. and E. Kanegsberg, editors, “Handbook for Critical Cleaning,” CRC Press 2011. 6.2 Qualifications of BFK Solutions LLC We are independent cleaning consultants; and we are the industry leaders in critical cleaning consultants. Our company, BFK Solutions LLC, was founded in 1994. We have decades of experience in the field of critical and industrial product cleaning. We are editors of the “Handbook For Critical Cleaning,” CRC Press. The book was recently revised and expanded to a two volume second edition (2011). We have conducted numerous public and private seminars and tutorials for groups such as USC School of Periodontics, UCLA, National Manufacturing Week, NIST, Cal/OSHA, IPC, SMTA and the International Thermal Spray Association as well as industries involved with critical applications such as aerospace component, electronics assembly, precision optics and medical device manufacture. We are members of the Continuing Education and Outreach Faculty at the UCLA/UC Irvine Southern California Education and Research Center. We have well over 100 publications in cleaning and contamination control. Barbara is a recipient of a U.S. EPA Stratospheric Ozone Protection award. We participate in Cal/OSHA advisory committee meetings. We contribute columns that appear regularly in technical publications in the U.S. and in Europe. These include critical cleaning and contamination control columns for “Controlled Environments Magazine,” a column covering business updates that appears for “Process Cleaning Magazine,” a column covering metal finishing issues for “Galvanotechnik,” and one covering electronics assembly concerns for “PLUS.” As independent consultants, our projects are not contingent on the sale of cleaning agents or cleaning equipment. The above comments and observations provided to the OTC are not funded by cleaning agent or cleaning equipment manufacturers or suppliers. Please do not hesitate to contact us if you would like more complete statements of our qualifications or if you would like additional technical information or reports. Kanegsberg comments to OTC 8