TOXICS USE REDUCTION INSTITUTE University of Massachusetts Lowell
600 Suffolk Street Wannalancit Mills, MA 01854 (978) 934

- 3275 fax: (978) 934

- 3050 www.turi.org

_____________________________________________________________________________________
Docket ID: EPA

- HQ

- OEM

- 2014

- 0328 Accidental Release Prevention Requirements: Risk Management Programs under the Clean Air Act

October 27 , 2014

We are pleased to offer comments on potential revisions to the Risk Management Program and related regulations. Our comments are provided in the context of our 25 years’ experience with Toxics Use Reduction p lanning in Massachusetts.

Background: Massach usetts Toxics Use Reduction Act (TURA)

TURA, which has been in effect since 1990, requires large

- quantity chemical users to report annually on their use of toxic chemicals, pay an annual fee, and conduct toxics use reduction planning every two years. The p rogram is implemented collaboratively by the Massachusetts Department of Environmental Protection, the Massachusetts Office of Technical Assistance and Technology, and the Massachusetts Toxics Use Reduction Institute ( the Institute ). Together, the three agencies provide a range of services, including training, grants, and technical assistance, to help companies reduce their use of toxic chemicals.

These services, combined with mandatory reporting and planning, have produced dramat ic results. Over the first ten years of the program, from 1990 to 2000, Massachusetts companies subject to TURA reduced toxic chemical use by 40% and on

- site releases by 90%. Over the next twelve years, from 2000 to 2012 , Massachusetts companies have conti nued to make improvements, r educing toxic chemical use by 23% and on

- site releases by 73 %. These figures are production

- adjusted, meaning that they represent true improvements in the efficiency with which companies use toxic chemicals per unit of product.

The TURA program works from a number of core principles i :

 Focus on use. The TURA program focuses on identifying the reasons why chemicals are used and wastes are generated. The focus is on protecting human and environmental health by reducing or eliminating the use of toxics wherever possible.

 Focus on hazard. TURA focuses on reducing or eliminating toxic or hazardous chemicals. There is no requirement to prove that exposure will occur, or to calculate risk, in order to take action to eliminate or reduce a hazard.

 Protection of workers, consumers, and the environment. TURA’s mandate is not only to prevent ambient environmental exposures resulting from industrial emissions, but also to take worker and consumer exposures into account. Avoiding risk shifting. TURA is intended to avoid risk shifting among environmental

media or among groups of people.

General observations

Toxics Use Reduction (TUR) planning requirements have produced excellent results in Massachusetts, yielding significant reductions in the use of toxic chemicals at industrial facilities, as well as economic benefits for Massachusetts businesses. The elements of TUR planning may serve as a useful model for EPA in designing a possible approach to assessing alternatives to highly hazardous chemicals under RMP.

The safer alternatives options analysis contemplated under the possible RMP revision is similar
to the process known as TUR planning, which large quantity toxics users are required to conduct every two years under TURA.

Many resource s are available to help EPA develop the specifics of a regulation of this kind , and to help companies complete successful analyses of the alternatives available to them

. These include resources developed with the TURA program and other state

- level pollutio n prevention programs, as well as specialized resources for hazard assessment and comparison of alternatives that have been refined in recent years at both the state and the federal level.

D. 1. a. Should EPA require a safer alternatives options analysis either as a new prevention program element, as part of the existing PHA/Hazard Review element, or as a separate new requirement under CAA section 112(r)?

The experience of the Toxics Use Reduction Act (TURA) program since 1990 is that requiring companies to conduct planning to identify and assess safer options every two years produces measurable results in terms of toxics use reduction (TUR) , improved worker health and safety, improved environmental performance and cost savings . Requiring businesses to conduct planning has led them to identify opportunities for improvement that they might not otherwise have identified.

TURA does not require businesses to implement options they have identified in their plans. This feature of TURA , while providing a numb er of benefits, also limits TURA’s impact in the absence of additional drivers for change . N ot all businesses choose to implement TUR options, even if those options are feasible. In some cases, external drivers help to overcome barriers to change. European regulatory restrictions, customer restricted substances lists, and other external factors have provide d additional motivation for Massachusetts companies to implement TUR options.

C omprehensive and informed regulatory review of planning provides additional impetus for companies to conduct planning in good faith . Regulatory review also encourages companies to be more thorough in their evaluation of options

. D. 1. b. How should safer alternatives be defined if it were to be a requirement un der CAA section 112(r) regulations? What specifically should a safer alternatives analysis requireand how would this differ from what is already required under other provisions of the

RMP?

Because of the work that state agencies, NGOs, and leading compani es have already completed regarding principles and procedures for alternatives assessment, there are ample resources from which EPA can draw in creating RMP requirements as well as resources for regulated businesses.

It may be useful to draw upon some ele ments of the definition of Toxics Use Reduction (TUR) under TURA. This definition is as follows:

“Toxics use reduction,” in

- plant changes in production processes or raw materials that reduce, avoid, or eliminate the use of toxic or hazardous substances or generation of hazardous byproducts per unit of product, so as to reduce risks to the health of workers, consumers, or the environment, without shifting risks between workers, consumers, or parts of the environment. Toxics use reduction shall be achieved t hrough any of the following techniques:

1. Input substitution, which refers to replacing a toxic or hazardous substance or raw material used in a production unit with a non

- toxic or less toxic substance;

2. Product reformulation, which refers to substitu ting for an existing end

- product an end

product which is non

- toxic or less toxic upon use, release or disposal;

3. Production unit redesign or modification, which refers to developing and using production units of a different design than those currently u sed;

4. Production unit modernization, which refers to upgrading or replacing existing production unit equipment and methods with other equipment and methods based on the same production unit;

5. Improved operation and maintenance of production unit equi pment and methods which refers to modifying or adding to existing equipment or methods including, but not limited to, such techniques as improved housekeeping practices, system adjustments, product and process inspections, or production unit control equipm ent or methods; or

6. Recycling, reuse, or extended use of toxics by using equipment or methods which become an integral part of the production unit of concern, including but not limited to filtration and other closed loop methods.

However, toxics use re duction shall not include or in any way be inferred to promote or require incineration, transfer from one medium of release or discharge to other media, off

- site or out

- of

- production unit waste recycling, or methods of end

- of

- pipe treatment of toxics as wa ste.

Some considerations related to the above definition include the following: The definition of TUR explicitly includes “workers, consumers, and the environment.”

For purposes of the RMP, this could be revised to include workers, members of the public, and the environment.

 The definition explicitly excludes risk shifting

.

 The definition includes specific techniques that may be used to achieve TUR.

One recent publication to which Institute staff contributed defines a safer alternative as: “ An option, i ncluding the option of not continuing an activity, that is healthier for humans and the environment than the existing means of meeting that need. For example, safer alternatives to a particular chemical may include a chemical substitute or a re

- design that eliminates the need for any chemical addition.” ii This language could potentially be used in combination with some of the more specific points included in the TUR definition above.

In developing a definition, it may also be useful to draw upon the principles outlined in the Commons Principles for Alternatives Assessment , a document developed by a group of organizations and institutions including the Toxics Use Reduction Institute. The Commons Principles define alternatives assessment as: “a process for identifying, comparing and selecting safer alternatives to chemicals of concern (including those in materials, processes or technologies) on the basis of their hazards, performance, and economic viability.” iii It enumerates six key principles:

 R educe ha zard

 M inimize exposure

 U se best available information

 R equire disclosure and transparency

 R esolve trade

- offs; and

 T ake action to eliminate or substitute potentially hazardous chemicals.

These six principles could be useful components in the development of a more detailed definition. iv

Other comments:

 For purposes of alternatives assessments conducted at the Toxics Use Reduction Institute, every alternatives assessment must include three broad sections: an environmental health and safety ha zard assessment; a technical feasibility assessment; and an economic feasibility assessment. Options that are rejected based on the hazard assessment do not need to be considered from a technical or economic feasibility perspective.

o The Institute’s guidelines have been developed for the purposes of alternatives assessments conducted by a government agency. Alternatives assessments developed by companies under a regulatory requirement are likely to be somewhat different.

 The Institute worked with partner agencies across the country to develop a guidance document that outlines principles and procedures for alternatives assessment. This resource should be useful to EPA in designing the components of a safer alternatives options assessmen t under the RMP update: Interstate Chemicals Clearinghouse (IC2)

,Alternatives Assessment Guide Version 1.0 (December 2013). Available at

http://theic2.org/articl e/download

- pdf/file_name/IC2_AA_Guide_Version_1.0.pdf

. o Among other points, the guide outlines a sequential process in which options are screened first based on hazard, then based on performance, and finally, to the extent that more than one option emerges, the remaining options are ranked in relation to one another based on cost, availabil ity, and (if relevant) exposure considerations.

o The guide also provides a detailed description of modules that can be used at each stage of analysis. For example, the Hazard Module includes an initial screen plus three levels of evaluation, with a higher level of detail and verification at each level. Resources that can be used within this module include EPA’s Design for the Environment Program Hazard Traits; GreenScreen for Safer Chemicals ; and the Quick Chemical Assessment Tool (QCAT), developed by the W ashington Department of Ecology.

 Another excellent resource is that provided by OSHA in its web

- based resource, “Transitioning to Safer Chemicals: A Toolkit for Employers and Workers ( ht tps://www.osha.gov/dsg/safer_chemicals/basics.html ). In this resource, OSHA defines a safer alternative in the occupational health context as “ an option that is less hazardous for workers than the existing means of meeting that need. Sometimes, this means choosing the option of not continuing an activity altogether; this also may include using chemical substitutes or product or process redesigns that completely eliminate the need for specific hazardous chemicals. ”

D.1.c. How should industries determine if a safer alternative exists for their particular process? What safer alternative chemicals are available for the listed RMP chemicals and for ammonium nitrate?

Industries can determine if a safer alternative exists for their particular process by examining a number of questions, including:

 Do other businesses or actors in the same industry sector already use a safer alternative? This should include an examination of businesses and other relevant actors both within and outside the US.

 Is there existing resear ch that demonstrates or investigates the viability of safer alternatives?

 Is the process or functional use of a chemical similar to another process for which safer alternatives have been identified?

A variety of detailed resources have been developed to help industries answer these questions. These include resources developed by the Interstate Chemicals Clearinghouse (IC2); the Substitutions Portal (Subsport); the Pharos Database; and the ASETSdefense database ( http://www.asetsdefense.org/ ), among others. Businesses, NGOs, and government agencies are continually expanding and improving these resources.

Under TURA, businesses are expected to make a good fait h effort to identify and evaluate potential safer alternatives. Companies pay fees when filing with the Massachusetts TURA program, and these fees help support research, identification and evaluation of safer alternatives, as well as written and web

- based materials, workshops, and demonstrations that make thatinformation available to other chemical users. All of these resources help businesses to identify

and assess safer alternatives.
EPA may also find it useful to examine the TURA program’s policy analyses for Higher Hazard Substance designations. (A Higher Hazard Substance designation lowers the threshold for reporting and planning to 1,000 lb/year for TURA

- covered sectors.) These doc uments review existing information on chemicals of high concern, note the ways in which businesses subject to TURA have already reduced or eliminated their use of these chemicals, and outline potential opportunities for further progress in TUR. Policy anal yses developed as background for HHS designations can be found at http://www.turi.org/TURI_Publications/Toxics_Use_Reduction _Policy_Analysis/Higher_Hazard _Substances_Policy_Analyses

. Most recently, regulations have been proposed to designate the following chemicals as Higher Hazard Substances: hydrogen fluoride, cyanide compounds, toluene diisocyanate, dimethylformamide, and n

- propyl bromide. If these regulations are promulgated in 2014, these designations will be effective as of January 1, 2015.

D. 1. d. What should facilities consider when determining if such technologies, when identified, are effective, available, and econom ically justified for their particular process or facility? Can the RMP national database, Lessons Learned Information System or other federal databases be structured to promote the exchange of information both within industry and with other stakeholders on potentially safer technologies?

Under TURA, businesses develop an economic analysis for financially feasible options, to help them determine whether a toxics use reduction option is economically feasible. Since TURA does not require businesses to implemen t TUR options, the results of the economic analysis are simply for internal decision

- making use within the business. Nonetheless, the requirement to conduct this analysis helps to ensure that businesses make more informed decisions than might be the case o therwise.
Under the original statute, there was also a requirement to calculate a “cost of toxics.” In this calculation, the business documented the total cost of using any listed toxic chemical used above the TURA threshold. The value of this approach is that it requires a business to explicitly identify all the costs associated with the incumbent technology, including costs of hazardous waste disposal, personal protective equipment for workers, liability insurance, and others.

D. 1. e. If EPA were to req uire facilities to undertake an evaluation of the potential to incorporate safer alternatives, what minimum criteria should this evaluation be required to meet? How would the evaluation determine if a particular alternative is feasible, cost effective and results in less risk? What requirements or incentives, if any, should there be for implementation of identified safer alternatives? How should any such requirements be structured and enforced?

Minimum criteria. Under TURA, a Toxics Use Reduction plan is re quired to include a number of components. These are described in detail in the TURA regulations (available at http://www.mass.gov/ eea/agencies/massdep/toxics/regulations/toxics

- and

- hazards

- regulations

and

- standards.html ). Briefly, some components of TURA planning requirements that may be relevant for the RMP update include the following: Statement of management policy related to toxics use reduction

 Statement of the scope of the plan

 Process flow diagram for each production unit, including information on amounts of toxic chemicals used in each production unit

 Cost of the use of each toxic chemical

 Procedures used to identify TUR o ptions (including the environmental health and safety assessment of those options)

 Description of TUR options

 Technical evaluation of TUR options

 Economic evaluation of TUR options

Additional detail is available for each component of the planning requirem ents. For example, in analyzing the economic aspects of the incumbent technology and safer alternatives, companies are directed to consider elements including indirect and d irect labor and materials costs; purchase or manufacturing cost of the toxic chemic al and alternative s ; capital and equipment costs; storage, accumulation, treatment, disposal, and handling costs associated with toxics and byproducts; costs associated with activities required to comply with local, state, or federal laws

or regulations; worker health or safety costs, including protective equipment and effects of possible accidents ; insurance; liability; community good will; and product sales lost to competing non

- toxic products.

Plans must be developed using good engineering practices and standard accounting practices, and must be complete d in good faith.

Plans must be certified by a TUR P lanner, including a statement that the planner believes the plan has been prepared in good faith, with a reasonable effort to identify and evaluate TUR options. (See additional information about TUR Planners, below.) Plans must also be signed by the senior management official of the facility, indicating that the information included is accurate and complete, among other points.

What requirements or incentives, if any, should there be for implementation of identified safer alternatives?
Based on the TURA program’s experience, s ome leading companies switch voluntarily to safer alternatives once they have evaluated them and found them to be technically and economically viable. O ther companies do not make these changes unless they are required to do so and/or have positive incentiv es for change. In Massachusetts, the TURA planning requirements have b een a good complem ent to other regulatory drivers. For example, Massachusetts manufacturers of electronic products were motivated to eliminate lead and other toxic chemicals by the Restr iction on Hazardous Substances directive in Europe , and the planning process ensured they were well prepared to make th ese changes in a timely fashion

. Another example is federal requirements related to use of perchloroethylene in dry cleaning facilities c o

- located with residences.

One further note we can offer based on experience in the TURA program is that there are benefits to requiring an economic analysis even if that analysis is used strictly for internal decision

- making purposes. In the experience of the TURA program, there are often advocates for TUR within each industrial facility. The process of developing a TUR plan, including aneconomic analysis, helps these internal advocates to make t he case to senior management that

environmental health and safety improvements are viable and potentially even profitable.

Other state

- level models that may be of interest include the alternatives assessment requirements under California’s Safer Consumer Products Regulation and under Maine’s Toxic Chemicals in Children’s Products law.

Role of planners. A key element of TURA’s success is the role of Toxics Use Reduction (TUR) Planners. Under TURA, companies are required to have their plans signed by a cert ified Toxics Use Reduction (TUR) Planner.

TUR Planners are individuals who receive training and certification from the state, and are responsible for reviewing and signing TUR plans. TUR Planners may be employees of a regulated company, or may be indepen dent consultants working with more than one company.

TUR Planners play an essential role in reviewing plans and ensuring that they continue to be of high quality o ver time. TUR planners take a 48

- hour class, must pass an exam, and have regular continuing education requirements, in order to ensure that they are well informed and up to date on new developments related to toxics use reduction.

D.1.f. Should EPA require facilities to use a safer alt ernatives evaluation method such as the CCPS Inherently Safer Technology Checklist?

A number of useful safer alternatives evaluation methods are available. The CCPS Inherently Safer Technology Checklist includes some useful elements, which could be expande d upon. Additional areas that are not covered in depth include potential savings associated with reducing hazard and potential liabilities associated with the hazard

.
It is worth noting that businesses that use chemicals to make products may have different needs from businesses that manufacture or process chemicals , so guidance should be evaluated with both these types of businesses in mind

. The TURA program is careful to make clear distinctions between options which are true hazard reduction (red uction or elimination of the toxic chemical) and options which merely contain or control risk. One of the core principles of TURA is that reducing or eliminating a toxic chemical hazard is the preferred way to reduce risk, as compared with risk control and mitigation

s trategies, which may contain but do not eliminate inherent hazards.

As noted above, t he TURA program focuses on hazard rather than exposure/risk. Exposure information can be a basis for additional concern about a substance, but not for overlo oking hazard.
In the Commons Principles for Alternatives Assessment, the first principle is to “reduce hazard by replacing a chemical of concern with a less hazardous alternative. This approach provides an effective means to reduce risk associated with a product or process if the potential for exposure remains the same or lower. Consider reformulation to avoid use of the chemical of concern altogether.”Methods for safer alternatives evaluation are reviewed in the Institute’s 2005 publication,

“Alternative s Assessment for Toxics Use Reduction: A Survey of Methods and Tools” (available

at http: //www.turi.org/TURI_Publications/TURI_Methods_Policy_Reports/Alternatives_Assessme nt_for_Toxics_Use_Reduction_A_Survey_of_Methods_and_Tools._2005 ). A more up

- to

- date overview is forthcoming in the OECD alternatives assessment toolbox. The IC2 publication, Alternatives Assessment Guide Version 1.0, is also a useful source of information on methods.

D.1.g. How should EPA and facilities address the risk tradeoffs that could result when changing a process to incorporate safer alternatives?

Risk tradeoffs

, which are a necessary part of planning, should be distinguished from risk shifting, which implies simply that a risk is being shifted from one area or medi um to another (e.g. from the general public to workers, or vice versa). Risk tradeoffs occur in all aspects of industrial planning , and can be addressed through transparency at each stage of planning

. Within a TUR plan, businesses use expert judgment and consider their specific circumstances in examining potential trade

- offs. Having a trained planner in volved in the process helps to ensure good decision making.

The guidance that the TURA program provides to businesses includes the following : If the assessment process does not identify an alternative that is an improvement for all pertinent hazard, technical and cost considerations, transparency about the process that is used in either selecting a substitute or choosing not to do so becomes even more critical. When implementing a substitution, care should be taken to minimize negative impacts of iden tified key trade

- offs. A core principle of TURA is continuous improvement. Businesses are required to revisit their toxics use reduction plans every two years because new options may emerge that were not identified before, or options that were rejected as technically infeasible may have become feasible in the intervening time period. Under TURA, businesses adopt the best possible option available at the time, but also continue to examine options going forward.

California ’s Safer Consumer Products Regulation requires businesses t o explain how they have made choices among alternative chemicals. v
D. 1. h. Should EPA consider requirements similar to those used by the State of New Jersey or Contra Costa County, California, and if so, why? What have been the benefits of such
programs in risk reduction or process safety for the facilities covered under these requirements? What have been the limitations or drawbacks of these programs?
An evaluation of these approaches is beyond the scope of the Institute’s comments. However, we observe t he following:

 In reviewing these resources, it may be use f ul to make clearer distinctions between prevention options and control options. Under TURA, hazard prevention options are always considered to be the preferred approach, compared with options to mitigate or control risks. California has proposed regulations that would go beyond the current requirements of

Contra Costa County; in particular, the proposed regulations include greater enforcement authority.

D. 1. i. If EPA were to develop regulatory requirements for safer alternatives, which facilities should be subject to those requirements? Should all RMP facilities be subject to such requirements, or only “high risk” facilities, such as refineries and large chemical plants? How w ould “high risk” be defined? Are there particular processes or chemicals that should be targeted or prioritized for implementation of such requirements?
In the Institute’s experience, all facilities can benefit from the toxics use reduction planning
proces s and from a careful assessment of their options for reducing or eliminating hazards. This benefit is not limited to the highest risk facilities.

D. 1. l. If RMP facilities are required to perform safer alternative options analyses and implementation plan s, should EPA require that the analyses and/or implementation plans be submitted to the Agency? Should EPA have any role in approving such analyses or plans? In lieu of an approval, can EPA promote safer alternatives through reporting and the dissemination of information on potentially applicable practices?

Under TURA, companies are required to keep a copy of their toxics use reduction plan available onsite, and must submit a brief summary of that plan to MassDEP. MassDEP inspectors are able to review the plans on

- site as part of an inspection.

For the most part, the TURA program relies on TUR planners for quality assurance. There are many advantages to this approach, but one limitation is that MassDEP does not reg ularly have the opportunity to review all the plans together. This limits the ability of the program to track patterns, and opportunities, at a level of detail beyond what is available from the plan summaries.

The TURA program employs a variety of approac hes to promote safer alternatives through dissemination of information on potentially applicable practices. This includes peer mentoring work groups and demonstration events, among other activities. Businesses have reported that this assistance is useful t o them.

D.1. n. What would be the economic impacts of requiring facilities to analyze safer alternative options? Are there any special circumstances involving small entities that EPA should consider?

In some cases, safer alternatives analyses will lead to economic savings.

 The TURA program creates a variety of benefits for small and large businesses in Massachusetts. Among other benefits, TURA program services help companies to identify opportunities to reduce operating costs, improve efficiency and expand markets (e.g. through competitive positioning in European markets). These benefits for individual companies are detailed in the TURA program’s many company

- specific case studies.

 C ompany representat ives have indicated that they have significantly improved production efficiencies as a result of the TURA program.

 The most recent survey of TURA filers found that 51% experienced improved worker health and safety; 41% achieved financial savings; 33% ach ieved improved compliancewith other state or federal regulations; 29% achieved improvements in production

efficiency; and 21% achieved improved product marketing, all as a result of the TUR planning and implementation process.

Under TURA, small busines ses report significant benefits from the planning process. Providing technical and/or financial assistance to these businesses can help to ensure th ey achieve the maximum benefit from the process.

i Summarized from Toxics Use Reduction Institute, “Decision Making Under TURA: Process Overview and Reference Guide.” Methods and Policy Report No. 28, published 2010, updated May 2014.

ii From Tickner, J. and Eliason, P. Alternatives Assessment for Chemica ls: From Problem

- Evaluation to Solutions

Assessment and Implementation: A background paper created for the March 31

– April 1, 2011 Interagency Discussion on Alternatives Assessment, EPA Potomac Yards Conference Facility, Crystal City, VA. March 24, 2011
iii L owell Center for Sustainable Production et al. The Commons Principles for Alternatives Assessment (includes consensus definition of alternatives assessment). 2013 October. http://www.turi.org/Our_Work/Research/Alternatives_Assessment/Commons_Principles_for _Alternatives_Assessm
ent iv Lowell Center for Sustainable Production et al. The Commons Principles for Alternatives Assessment (includes consensus definition of alternatives assessment). 2013 October. http://www.turi.org/Our_Work/Research/Alternatives_Asse ssment/Commons_Principles_for_Alternatives_Assessm
ent

v California Code of Regulations. Division 4.5. Title 22. Chapter 55. Safer Consumer Products. Article 5. Alternatives Analysis. Section 69505.7 Alternatives Analysis Reports.