Document 8nG8GLeQbpqYzx8jDa9Mnr4Z

CHEMICAL MANUFACTURERS ASSOCIATION October 1, 1992 TO: Existing Chemicals Testing Task Group SUBJECT: "influence of CBI Requirements on TSCA Implementation" by Hampshire Research Associates, Inc. (March 1992) "Influence of CBI Requirements on TSCA Implementation" by Hampshire Research Associates, Inc. (March 1992) is enclosed for your information. The Chemical Reporting Task Group is taking the lead on this issue and will be meeting with EPA on Wednesday, October 14, 1992. A meeting notice is enclosed (57 FR 45389; October 1, 1992), Draft talking points for the meeting are also enclosed. If you have comments on CMA's preliminary position that should be addressed prior to the October 14 meeting, please contact Rich Kraska, Lubrizol Corporation, at 216/943-1200 ext. 5167 or Charles Walton, CMA, at 202/887-1365. If you feel this document warrants discussion at the October 22, 1992, task group meeting, please contact me so that it may be added to the agenda. If you have any questions, please call me at 202/887-1274. Sincerely, Associate Director Health Programs cc: G. Baker K. Belton F. McEldowney C. Spearing S. Conti C. Stack B. Francis E. Winkelman 2501 M Street. NW, Washington, DC 20037 202-887-1100 Panafax 202-887-1237 Telex 89617 (CMA WSH) CMA 052210 March, 1992 Hampshire Rimveh Associates, Inc. 9420 Fores* Hsvsn Drive Alexandria Va 22300 (703) 903-9998 Influence of CBI Requirements on TSCA Implementation March, 1992 Sheila A. Ferguson Laurie C. Meree Warren R. Muir, Ph.D. John S. Young, Ph.D. EPA Contract Numbers: 68-DO-0165 / 68-DO-0200 Work Assignment Numbers: 1-02 / 2-09 EPA Project Officers: Phyllis H. Bennett / Eileen Fesco EPA Work Assignment Manager Frank V. Caesar HRA Project Manager John S. Young Hampshire Research Associates,Inc 9426Forest Haven Drive Alexandria, VA 22309 (703)683-6695 CONTENTS EXECUTIVE SUMMARY......................................................................................... m INTRODUCTION .......................................................................................................................................... TSCA and Rjght-to-Know ................................................................................ ...................................... Information Gathering and Dissemination Provisions ...................................................................... Unique Aspects of TSCA Data............................................................................................................... Confidential Business Information........................................................................................................ Purpose and Scone of This Report........................................................................................................ 1 2 2 3 4 5 CLAIMING CONFIDENTIAL BUSINESS INFORMATION.................................................................... 6 THE LARGE AND INCREASING VOLUME OF CBI CLAIMS FROM 1977 to 1990 ......................... The New Chemicals Program (Section 5)............................................................................................ PMN Submissions.............................................................................................................................. Polymer, Low Volume, end Tost Market Exemption Submiaions...................................................... Bona Fide Submissions........................................................................... Substantial Risk Information: Health and Safety Data (Section 8) ................................................. 8(e) end FYI Submissions.................................................................................................................. Significant Advene Reactions (Section 8(c)) ..................................................................................... Health and Safety Studio Submitted Under Section 8(d).......................................,........................ CA1R Submissions .............................................................................................................................. PAIR (8(a) Level A) Submiaions...................................................................................................... TffMng of Hazardous Chemicals Identified under the Act................................................................................... Atfioii 6 Submissions......................................................................................................................... Chemical Inventory Reporting................................................................................................................ Inventory Data ................................................................................................................................... Summary of CBI Claims.......................................................................................................................... 7 7 8 8 9 9 10 11 11 12 12 13 13 14 14 14 15 SUBSTANTIATION AND REVIEW OF CBI CLAIMS.............................................................................. Statutory Criteria for Rcrtewint Claims............................................................................................... Statutory Penalties for CBI..................................................................................................................... Resource Considerations and Actual Practice..................................................................................... gubffitttert Anftrt CWW "fttll .............................................................................. 16 16 17 17 18 SIMILAR DATA ARE NOT CONFIDENTIAL UNDER RELATED STATUTES ................................... 20 LEGAL AND TECHNICAL CONSIDERATIONS........................................................................................ 23 CONSEQUENCES OF CURRENT CBI CLAIM AND REVIEW PRACTICES....................................... CPLPrwatt Uttirtto.QiflkniT for ETA........................................................................................ CBI Seanity Procedures ere Strict .................................................................................................... CBI Seemity Proritm are Efltatft*.................................................................................................... CBI Security Entails Dina end Indirect Cents ................................................................................ OPPT is Improving its Efficiency in Pmmang CBI......................................................................... EPA Cota Associated with Invalid CBI daime................................................................................ 25 25 25 25 26 27 27 CMA 052213 Availability of Data Outside OPPT .................................................................................................... Other Offices Within EPA............................................................................................................ Other Federal Agenda........................................................................................................................ State Governments............................................................................................................................... Environmental Groups ....................................................................................................................... Labor Organisations............................................................................................................................ EPA Rulemaking (Asbestos)................................................................................................................ EPA Efforts at Data Distribution ...................................................................................................... Limits on Information Dissemination Under TSCA............................................................................ Missed Opportunities...................................................................................................... 2S 2S 2$ 30 30 31 32 32 33 33 EXCESSIVE CBI FRUSTRATES THE INTENT OF TSCA....................................................................... 35 STRATEGIES FOR REDUCING THE IMPACTS OF INAPPROPRIATE CBI CLAIMS .................... Congressional Options............................................................................................................................. Class Detmninations .......................................................................................................................... Adopt the Successful EPCRA Trade Sea* Framework ..................................................................... Authorise Sharing of TSCA CBI with State Governments.................................................................. Establish Additional Guidance............................................................................................................ EPA Options Whether or Not Comma Acts ...................................................................................... Cias Determinations ............................................................................................ 'Jaw Boning ....................................................................................................................................... Get Tough an Egpegyous Casts............................................................................................................ Eliminate Overly Burdensome Administration of CBI........................................................................ EPA Options If Congress Does Not Act................................................................................................ Report Cards ....................................................................................................................................... Reporting ofA&egutts end Gmmic Data ........................................................................................ 'Upfront* Suhaantiatinn..................................................................................................................... Sunsett/Rasuhttanriatitm..................................................................................................................... Fob on CBI Claims Based on Oast Deluminatiotu.......................................................................... 36 36 36 36 37 37 37 37 38 38 39 39 39 39 39 40 40 CONCLUSIONS .............................................................................................................................................. 41 FIGURES........................................................................................................................................................... 43 TABLES.............................................................................................................................................................. 57 APPENDIX A: THE PMN REPORTING FORM...................................................................................... 59 APPENDIX B: THE NEW CHEMICALS (PMN) PROGRAM................................................................ 75 APPENDIX Cs REPORTING AND RECORD-KEEPING (SECTION O............................................... 77 APPENDIX Xh HAZARDOUS CHEMICALS IDENTIFIED UNDER THE ACT................................... 79 APPENDIX E: CBI SECURITY PROCEDURES ...................................................................................... 81 APPENDIX F: SCREENING INFORMATION DATA SET (SIDS) CHEMICALS AND KNOWN HUMAN CARCINOGENS IDENTIFIED IV NTP ......................................................... 89 ii CMA 052214 EXECUTIVE SUMMARY TSCA Includes Unique Data Collection Provisions Prior to the enactment of the Toxic Substances Control Act (TSCA). no one knew the number or identity of chemicals in commerce in the United States, much less had information on their production, distribution, use, or health and environmental effects. TSCA has provided an extensive set of tools to collect just such information from industry. If the information does not already exist, industry can be required to develop it. Thus, TSCA is a unique and extremely important source of information that is potentially valuable not only to the United States Environmental Protection Agency (EPA) for its own regulatory efforts, but also to other federal, state, and local programs. The data collected under TSCA also have the potential to benefit the scientific community as it attempts to better characterize environmental concerns, and industry as it works toward reducing risks of its chemicals. This information further has the potential to benefit workers and the public who risk the consequences of being exposed to any harmful chemical in commerce. Significant amounts of TSCA data are unavailable anywhere else, and TSCA provides the only comprehensive view available of what is known (and not known) about the commercial flow and/or environmental effects of commercial chemicals. CBI Claims Severely Limit Access to TSCA Pam Under TSCA, large amounts of potentially valuable dau have been collected and are being maintained by EPA However, most of the dau are unavailable to scientists, public interest groups, or the general public, became they are being held as confidential business information (CBI). While there are several circumstances under which dau submitted by companies are and should be handled as legitimate trade secrets, the majority of the confidentiality claims affecting dau submitted under TSCA have not been substantiated, and a significant fraction of these claims would appear not to be supporuble under the suture. Mainuining large volumes of dau as CBI not only denies access to interested outside users, it also leads to high costs for the Office of Pollution Prevention and Tads (OPPT), which administers TSCA to keep the dau secure, impedes the program's ability to develop regulations openly, and makes it difficult for other federal officials to use the data, k also prevents OPPT from sharing the knowledge it gains from reviewing such dau about the chemical attributes that give rise to significant health and environmental risks. Thus, TSCA CBI is Impeding government regulatory programs, scientific research, industrial chemical stewardship programs, worker and community right-to-know, and industrial accountability. The history of EPA regulation of asbestos provides a telling cue in point. The public and interested parties were precluded from meaningful participation in rulemaking, because the documents developed by EPA to support its proposed role were cowered by CBI claims, and could not be made public Potential usen of TSCA dam are not only hindered by the lack of access to the dau, but they are also undermined by an inability to ascertain the scope of the dau that are being held as confidential. In ther words, there is no way for outside usen to know whether or not EPA is in possession of dau relevant to their interests. Therefore, few groups or individuals, aside from industry, have sought to obtain TSCA data. in CMA 052215 The amount of TSCA data claimed and held as CBI is sizeable by any standard, and includes more than 90 percent of all premanufacture notices for new chemicals. more than 95 percent of all polymer exemption submissions, more than 25 percent of all substantial risk notifications (80 percent of those submissions with claims make such claims for chemical identity), and more than 20 percent of all reported health and safety studies. That these TSCA CBI claims are excessive is shown by the following examples: Data collected under TSCA's Preliminary Assessment Information Rule have at least 10 times as many confidentiality claims, and probably more than 1,000 times as many claims as Toxics Release Inventory Data submitted to the same EPA program under the Emergency Planning and Community Right-to-Know Act (EPCRA) for a comparable set of information and reporting entities. For the limited number of submissions that EPA has had the resources to challenge, submitters have seldom been able to substantiate their claims. (This includes nearly all the substantial risk notices with chemical identity claims.) Many of the claims dearly foil outside of what may be claimed as confidential under the explicit provisions of TSCA (eg. health and safety data submitted by industry). Examples indude: Claiming chemical identity as CBI on a substantial risk notice, because of concern that toxicity data might be 'misinterpreted.' submitter identity and plant site information as confidential, although this information was publidy available, to avoid embarrassment over inadequacies in a medical surveillance program. When up-front substantiation requirements for CBI claims were dropped in 1982 for new chemical prrminufomnc notifications, the percentage of submissions subject to such claims rose noticeably. A review of health and safety data on 20 chemials that have been designated as an international priority for evaluation and control indicated that EPA is holding as confidential five studies submitted under Section 8(d). fownil SttiMhi at AilltMt IP Unit Ewrata-CM Qlmi EPA cannot prevent firms from making CBI claims under TSCA. and must go through s series of labor-intensive steps to declassify any dam that it beiicvm do not meet the statutory criteria for such claims. Therefore, only Congressional action an truly solve the problem of excessive CBI under TSCA However, there ate a PH***1 number of admmntrative actions that appear to be available to EPA to make TSCA dau mote available to the public IV CMA 052216 Alternatives to Congressional Action Should Congress decide not to amend the CBI provisions of TSCA, EPA does have some additional alternatives to discourage inappropriate CBI claims. These might include: Publicly disclosing who is making what type of invalid claims (without divulging any confidential specifics); Reporting aggregate statistics on information covered by CBI claims, so that at least generic information on risks is available; Requiring up-front substantiation for all TSCA CBI claims; Instituting procedures that would require re-substantiation of claims after the expiration of fixed periods. Imposing fees for CBI claims. Reform of TSCA CBI procedures, and the elimination of abuses, is possible to some extent without Congressional intervention. However, Congressional action would greatly expedite such reform, and is absolutely necessary to address certain issues, such as access to TSCA CBI by state governments and ihe ability to prohibit certain classes of CBI claims. vi CMA 052217 Legislative Options Congressional action will probably be required to modify TSCA before the information reported and generated under the Act can serve more than its current limited regulatory uses to promote environmental health. Congressional options include: An explicit legislative restriction on the classes of information that may legitimately be claimed as CBI (eg. prohibiting claims on specific data elements, such as the identity of chemicals for which substantial risk notices are submitted, or on combinations of data elements, such as claiming both the chemical and the submitter identity as CBI)- Following the successful pattern for confidentiality claims demonstrated in Toxics Release Inventory reporting under EPCRA; o requiring up-front substantiation of CBI claims; o mandating that claims be made by a senior corporate official; a providing criminal and civil penalties for false claims of confidentiality; o limiting cutTM* to a narrow range of dau elements; o requiring that each submission covered by a CBI claim be made available to the public with a generic name for each confidential element, so that users of TSCA dau can know the cam nature of dau covered by CBI claims. An ccplidt authorization for EPA to share dau with sute governments, and a specification of security requirements that would fadliute dau-sharing with other federal agencies. Providing EPA with more specific guidance on appropriate provisions for the protection of CBI (eg specifying sunset periods beyond which additional substantiation of CBI claims would be required). Options Available to EPA EPA does have a number of alternatives available to it to limit inappropriate CBI claims, which would supplement Congressional action. These actions by EPA would also have some saluuty effects even in the absence of Congressional action. These include: Attempting to develop dais determinations defining circumstances when EPA considers CBI claims to be invalid; . Discussing (forcefully) the need to limit inappropriate CBI claims with industrial groups and chief OBcnthe officers and seeking volunuty changes from them; Continuing the current campaign to challenge those claims least likely to be susuinable, and, in sms of invalid claims, attempting to invoke 18 USC 1001 covering false claims to the Making internal reforms, under the terms of the consent decrees currently in force, to decrease the administrative burdens of TSCA CBI (several of these are being implemented). V cm 052218 - INTRODUCTION As recently as fifteen years ago, the American public had virtually no information on the risks posed by tone chemicals in commerce, despite the fact that they were being exposed to these chemicals in the workplace, at home, and outdoors. In addition, neither the scientific nor regulatory communities had the information they needed to assess and control the risks posed by toxic chemicals., Indeed, information was not even available on what, or how many, chemicals were in commercial use in the United States. Adequate information to assess health risks was available for only a tiny portion of the universe of chemicals to which people might be exposed. The initial proposal for a Toxic Substances Control Aa (TSCA) was developed in 1971 in the context of a series of unfoneen discoveries of the toxic potential of chemicals in commercial use. These discoveries included the widespread contamination of fish with the heavy metal mercury, and the identification of serious health risks associated with contamination from polychlorinated biphenyls (PCBs), which had been widely used in electrical equipment As the Administrator of the United States Environmental Protection Agency (EPA), Russell Train, noted: Most Americans had no idea, until relatively recently, that they were living so dangerously. They had no idea that when they went to work in the morning, or when they ate their breakfast-that when they did things they had to do to earn a living and keep themselves alive and well-that when they did things as ordinary, as innocent, and as essential as eat, drink, breathe, or touch, they could, in fact, be laying their lives on the line. They had no idea that, without their knowledge or consent, they were engaging in a grim pme of chemical roulette whose result they would not know until many yean later.1 During the six years of debate over the legislation before final enactment of TSCA, there was a seemingly endless stream of revelations regarding chemical risks, including: liver cancers in rubber workers induced by vinyl chloride; contamination of Lake Superior and water supplies drawn from the lake with asbestos-like fibers; plastidzeis in blood, coming from plastic blood bags; polybrominated biphenyl (PBB) poisoning of ante in Michigan; kepone poisoning of workers and the James River fat Virginia; "Tris* cancer concerns, from its use as a fire retardant in children's sleepwear, and stratospheric ozone depletion induced by cfalorofluorocarbons and other chemicals. TSCA was enacted in 1976, in an effort to identify the risks posed by chemicals in commercial use, and to ensure that the risks of damage to human health and the environment from the manufacture and use of unde chemicals would be ""<"The Act gives EPA broad authority to collect information on chemicals from manufacturers, processors, and importers throughout the United States. It was hoped that by making this information available to the public, informed choices could be made by everyone concerning cbemkab and their ase. TSCA also gives EPA the potential to regulate any chemical at any stage in its life cycle from syntheris and development through commercialization, sale, and use, to disposal upon a finding by the Agency that the chemical may pose an unreasonable risk. One impetus for the passage of TSCA was to fill existing gaps in the federal government's authority to regulate risks from toxic chemicals. Earlier environmental lavs had focused on particular environmental media (air, water) or industrial and commercial practices (waste disposal). TSCA 1 Legislative History of the Toxic Substances Control Act. U.S. Congress, November 15, 1976. at p. 161. CMA 052219 addressed the entire lifecycle of a chemical substance, from synthests to disposal. However, rather than simply filling regulatory gaps, most provisions in the Act were intended to provide information needed to assess the risks of chemicals, and, thus, to forestall problems, rather than correct them. Reporting provisions for existing and reasonably ascertainable information were broadened from the initial Nixon Administration proposal, as were authorities to require testing to develop new data. Finally, premanufacture notification requirements were added to the Act. The concern was clearly to provide the information needed to support sound regulation of toxic chemicals, but even more so to provide perspectives on chemicals that would move the entire country away from a reactive approach to unknown problems towards a fuller understanding of chemical health and environmental risks. As stated in the Report of the House of Representatives, `the bill provides for the collection of information regarding commercially produced chemicals so that the total exposure to a chemical and its total effect on health and the environment can be monitored and evaluated.*1 TSCA was drafted obtain information needed on the effects of chemicals and on human and environmental exposures to chemicals. TSCA and Rteht-toKnow Public access to the data collected and generated under TSCA was recognized as being essential to the achievement of the statute's ambitious goals. For example, one of the major sponsors of the legislation. Senator Harike of Indiana stated, I think the essential element of this legislation is that it has attempted to provide for the individual-sot only who works, but for the rest of American society, the right to know what is in store as for as the toxicity of chemicals is concerned. The foci of it is that not only do worken not know and the general public not know, but in many cases the manufacturers and distributors and business people do not know.* An example of CongreVs recognition of the need for public access to data on toxic chemicals is its decision to add Section 8(d) and related reporting provisions to TSCA. Congress decided to require that health and safety information be reported by aD companies under TSCA rules and to make all health and safety studies publicly sensible. Thus, Section 8(d) offered the scientific community (and the public) a window into a pool of unpublished health and safety studies that some have estimated to be larger than the entire published literature. Other provisions of TSCA, such as Sections 8(a) and 8(e), also require the reporting of data on the health and safety effects of chemicals. Information Gethtrtnn end DtoremlnstiotLPngfoteBf TSCA contains brand reporting and information provisions. Under Section 8(a), the EPA Administrator can reqnlre indutry to report almost any existing or reasonably ascertainable (non* financial) informstfoo about the u*i its produces, processes, distributes, uses* or disposes. Such information can be required about specific chemicals and uses or about broad classes of chemicals and * Legislative History of the Toxic Substances Control Act US. Congress, November 15. 1976. it p. 409. Legislative History of the Toxic Substances Control Act. U.S. Congress, November 15, 1976. at p. 218. CMA 052220 uses. In fact, such reporting requirements can be constructed to encompass any logical class of chemicals, uses, or other groupings, except the group 'all new chemicals.' Under Section 8(b), EPa was required to exercise its reporting authorities to obtain an inventory of all existing chemicals in commerce, EPA acted in 1977, and supplemented the inventory with reporting on the site and amount of manufacture (or import). (The inventory is regularly updated and the production information has been updated twice since.) In addition to Section 8(d) authority, mandating that EPA collect unpublished health and safety studies from industry, two other important authorities in Section 8 allow EPA to require reporting of health and safety data. First, under Section 8(e), industry is required to report to EPA any additional data that 'reasonably supports the conclusion that a substance presents a substantial risk of injury to health or the environment* Under Section 8(c), EPA is to establish rules for industry to maintain and report records of adverse reactions to health or the environment of its chemists and of allegations of such advene reactions. Finally, T5CA grants EPA authority to require industry to generate any missing data that are needed on new chemicals (under Section 5) and easting chemists (under Section 4 test rulo). For new chemists, if EPA determines that a chemical may pose an unreasonable risk to human health or the environment, it can require any studies necessary to make a risk determination. Under Section 4, EPA sn develop rules that require any taring that may be needed to develop information on chemists already in commerce. TSCA's information-gathering tools cover the entire universe of old and new chemists, and the entire range of uses of any chemisl, unless the chemist is alrsdy regulated as a pesticide, food or food additive, or drug. These tools cover all stages in the commercial flow of such chetnisls, from production, processing, distribution, and use, to treatment and disposal. They embrace information on production, use, exposure, and environmental release, a well a health and environmental effects. In fact, TSCA coven virtually any type of information about chemicals in commerce and their effects. By collecting information under TSCA, EPA can better set priorities for its regulatory and enforcement activities under aO its statutes. By making inch information publicly available, as required by the Act, EPA provide prodocen and nsen (both commercial and private) with the ability to make better decisions regarding chemicals, and requires prodocen to be publicly accountable for their actions. As has been illustrated by the impact of the Emergency Planning and Community Right to Know Act of 1986 (EPCRA) on corporate practices, such publidy available information may be a far more powerful influence on environmental quality than direct EPA regulation. Vjlag*.Agtt. dfJSCA Pitt TSCA is not the only, nor even the major source of information on tonic substances. Thousands of trade publications and the huge body of scientific literature contain much information about toxic substances. However, there are two aspects of the TSCA data are both important and unique. Fust, significant amounts of 7SC4 data an unavailable anywhere else. Under TSCA, EPA an require companies to submit information on their production, distribution, uses, and disposal of chemicals, as well a information relating to their possible health or environmental effects. An important portion of the information that companies have on their chemicals ha not been published. Therefore, TSCA is receiving data not available anywhere outside of the companies submitting them. In addition, if such dam do not exist, but EPA finds that the chemical may pose an unreasonable risk or that the chemical has large production and ha significant or substantial exposure, then the Agency may 3 CMA 052221 require companies to generate such data. Thus, TSCA information-gathering authorities can and Uo nil key gaps in information about chemicals. For example, for hundreds of chemicals designated as high priority for testing by the Interagency Testing Committee, TSCA has been used by EPA first to obtain all unpublished health and safety data and then to have industry conduct tests to HU key gaps in these data. Second, TSCA provides the only comprehensive view available of what is blown (and not biown) about the commercial flow and/or environmental effects of commercial chemicals. For example, nowhere else is there a complete overview of what chemicals are being produced, in what quantities, and where. Nowhere else are there complete compilations of the existing health and safety data on important environmental chemicals, including large databases containing unpublished data. Nowhere else is there a complete overview of what new chemicals have been developed and introduced into commerce in the U.S. And, nowhere else is there a complete overview of the commercial uses of chemicals that pose high risks, such as lead and asbestos. As a result of these information-gathering provisions, OPPT has an absolutely unique overview on chemicals. For example, it has no equal in knowledge of the chemical features that give rise to health and environmental concerns from having collected and reviewed thousands of published and unpublished health and safety studies on chemicals with'similar structural features. This is information of value not only to EPA in its oversight of new chemical development, but also to research scientists in their efforts t understand mechanisms of toxicity and drug action and to industry in its efforts to design and develop safer chemicals. Confidential Business Information Manufacturers, processors, and users of chemicals protea many trade secrets from disclosure to one another. Such trade secrets may involve for example: the nature of their research programs and marketing plans, the specific formulation of their products, the details of their process steps, or the economics of their operations. Disclosure of such trade secrets may allow domestic and foreign competitors to avoid the time and expense to independently develop such information, and, thus, can result in such competitors' obtaining an unfair competitive advantage over the company whose secrets have been disclosed. Recognizing the legitimate concerns of companies over unnecessary disclosure of such trade secrets, TSCA contains provisions limiting disclosure of confidential business information. However, given TSCA's overall thrust of improving the public's access to information, such provisions place narrow limitations on what information is to be publicly withheld. In particular. Section 14(a) of TSCA mirrors the provisions of the Freedom of Information An (FOIA), which allow *any information* submitted or obtained under TSCA to be as confidential, but limit what may be held confidential to data needed to protea trade secrets or financial information.* Moreover, under Seaton 14(b), the range of submitted data from health and safety studies that can be protected as C8I is far more Even information that would normally be protected from disclosure under FOIA may be disclosed under this provision of TSCA Only dam that disclose 'processes used in the manufaauring or processing of s chemical substance or mixture or, in the case f a mixture, ~ any data which disctosci the portion of the mature comprised by any of the chemical substantia in the mixture* is prohibited from release That Congress did not intend for these limitations to restrict information necessary to protea public health and safety is demonstrated by the faa that Seaton 14(a) also contains a provision tor disclosure of information that would otherwise be entitled to protection as TSCA C8I under several sets of 4 CMA 052222 conditions. C8I may be disclosed if doing so is necessary to prevent unreasonable risk. Officers and employees of the United States and contractors may review confidential information if it is necessary to perform their duties in protecting health and the environment or for specific law enforcement purposes (for example, if worker ecposures are possible, officials of the Occupational Safety and Health Administration (OSHA) are entitled to review TSCA CBI, in order to carry out their duties under the Occupational Safety and Health Act). Disclosure is also allowed when relevant to a proceeding under TSCA, although all efforts must be made to preserve the confidentiality of substantiated CBI to the extent practicable. In addition. Congressional committees may review confidential information obtained under TSCA upon written request by the committee seeking information. Purpose and Scope of This Report This report examines whether the CBI provisions or TSCA, either as explicitly mandated by the statute or as put into practice by EPA have had a deleterious effect on the implementation and impact of the law. It considers procedures for claiming CBI and the number and nature of CBI claims that have been made regarding information submitted to EPA under TSCA Subsequent sections examine the validity of the claims that have been made, the impacts of CBI claims on the utility of TSCA information for EPA and the public, and the advantages and disadvantages associated with some proposed alterations of TSCA CBI procedures. This assessment of TSCA CBI is based upon a review of the legislative history and other legal and historical documents to identify the statutory, regulatory, and case-law constraints on confidential claims under TSCA Statistical analyses of TSCA data contained in EPA databases were performed to quantify and document the scope of CBI claims through FY 1990. As a final component of the assessment, interviews were conducted with EPA staff and outside parties interested in data submitted under TSCA to ascertain the extent of the problem caused by claims of confidentiality. These interviews also sought opinions on the utility of various potential modifications of EPA confidentiality procedures. CMA 052223 CLAIMING CONFIDENTIAL BUSINESS INFORMATION Claiming information as confidential is a simple procedure under TSCA. Information submitted is claimed as confidential business information by marking the specific information with a label such as "confidential,* 'proprietary,* or `trade secret.' Under some sections of TSCA, EPA has provided for information to be claimed as confidential by simply checking a box on the appropriate form (eg. new chemicals under Section 5). Under other sections, written substantiation of the confidentiality of the claim is required. For example, claims associated with Inventory reporting require derailed answers for a list of questions specified under 40 CFR 710.7(a) and (b). For several types of submissions (including Premanufacture Notices, health and safety studies, and records of significant adverse reactions), the regulations issued under TSCA specify that two copies of the information are submitted. The first copy must contain all the information required for reporting. This copy of the submission is used internally by EPA The second copy (also known as the 'sanitized version*) must contain only information not claimed as CBI and is placed in an open file available to the public These sanitized copies of submissions frequently do not indicate either the nature or amount of CBI information from the original submission that has been omitted. If the submitter fails to supply a sanitized copy, EPA notifies the submitter who then has either IS or 30 working days (depending on the applicable section of TSCA) to submit the second copy. If EPA does not receive this second copy, the confidentiality claim is waived and the information is placed in the open file. There are no penalties under TSCA for false claims of confidentiality. In stark contrast, the penalties applicable to EPA staff or contractors who reveal CBI (even if the CBI claim is frivolous) can be substantial Because the information submitted to EPA under various sections of TSCA differs, the nature of the information likely to be claimed as CBI, and the presumptions regarding CBL differ somewhat in the programs corresponding to these sections of the Act. The section below analyzes CBI claims that are clearly important from a health and safety point of view. 6 CMA. 052224 THE LARGE AND INCREASING VOLUME OF CBI CLAIMS FROM 1977 io 1990 Since FY 1982, there has been a massive increase in the number of CBI claims affecting information submitted to the EPA under TSCA. In part, this reflects a nearly exponential increase in the number of documents submitted to EPA under the statute. However, the increase in the number of CBI claims also reflects changes in CBI claim patterns from the early years of TSCA to more recent times. This increase m CBI claims affects many types of submissions, including Premanufacture Notices submitted pursuant to Section 5, substantial risk notices submitted pursuant to Section 8(e), health and safety studies submitted under Section 8(d), and so forth. Reports from databases maintained by EPA's Office of Pollution Prevention and Toxics (OPPT), which administers TSCA, were used to track the number and nature of CBI claims over the last 14 years. These non-CBI reports presented counts of the numbers of each type of document submitted in any fiscal year, the numbers of each containing any CBI claims, and the numbers containing CBI claims for each of several key data fields (eg. chemical identity, submitter identity, use, etc). Most of the relevant data are contained in the Document and Personnel Security System (DAPSS), although data on PMN submissions were obtained from the PENTA database. Data from FY 1977 through FY 1990 were analyzed.4 Submissions for each class of documents are described below. It is important to note that increases in the proportion of CBI claims for any submission type suggest an increase in the number of unnecessary, and therefore invalid, claims. There is no reason to expect, a priori, that submitters' need to protea truly confidential information has increased over the past 14 years; one would expect the proportion of data subject to legitimate confidentiality concerns to fluctuate somewhat, but not to markedly increase or decrease. If the proportion of submissions with CBI claims increases, the most probable explanation is that information of a type and level of sensitivity that was not previously claimed as CBI is being so claimed. The New Chemicals Program fScctlon 5) Section 5(a)(1) of TSCA establishes the Pre-Manufocture Notification (PMN) program which requires manufocturers or importers to provide 904iy notification prior to introducing a new chemical into commerce. A *new* chemical h defined as a commercial chemical not listed on the TSCA inventory. Manufacturers are required to submit available risk-related data including results of relevant health and safety studies, projected production or import volumes, oeposure estimates, and intended methods of disposal. (See Appendix A for a copy of the PMN form.) Based on the information provided in the PMN, EPA most assess the rislo to ascertain if the chemical may or will pose an unreasonable risk to human health or the environment. When EPA receives the PMN, number h assigned and a notice is sent to the submitter identifying the PMN number and the date on which the review period begins (40 CFR 72065). The standard review period is 90 days. The procedures for chiming any reported information as confidential are consistent with the general procedure. Claims of confidentiality for the chemical identity apply only to 4 OPPT also has complete data for FY 1991, but these have not been included in our analysis. In 1991, EPA's Confidential Systems Section phased out the use of DAPSS, replaang it with the Confidential Business Information Tracking System (CBITS). Because data for 1991 are contained In two separate systems, and the degree of overlap between the systems is undear, it would be impossible to analyze these data without individually camming each record for FY 1991 in each system. 7 CMA 052225 the period prior to commencement of manufacture or import for commercial purposes (40 CFR 720.85(a)). If the chemical identity of the new chemical substance is claimed as confidential, the submitter must provide a generic name at the time of the claim. Once a generic name is accepted by EPA and the submitter, it is published in the Federal Register. Exemptions to the PMN process are made for polymers (40 CFR 723.250) chemicals developed solely for use in research and development (40 CFR 72036), chemicals distributed solely for test market purposes (40 CFR 72038), and chemicals produced in low volumes (less than 1,000 kilograms per year (40 CFR 72330). A company may also be exempt from reporting if the new chemical is identical to one listed with EPA under a generic chemical name. EPA will reveal that the chemical is already on the inventory list once the company establishes that it has a bona flda intent to manufacture the chemical. (Additional information on the new chemicals program is included in Appendix B.) A company must send a Notice of Commencement of Manufacture to EPA no later than 30 days after it begins manufacturing or importing the chemical substance for commercial purposes. This notice reports such information as the chemical identity, pre-manufacture notice number, and the date when manufacture or import started. If the submitter would like to maintain the chemical identity as confidential, he or she must reassert and substantiate the claim, or else the chemical identity is placed on the public inventory without notice (40 CFR 720.102(c)). A submitter may not claim the chemical identity confidential after manufacture or import unless a claim of confidentiality was made prior to manufacture or import (40 CFR 72085 (b)(1)). Although the statute is not explicit on other claims, it is EPA practice to maintain any other information claimed in the PMN as CBI after the Notice of Commencement has been received by EPA, without requiring further substantiation. PMN Submissions As cut be seen from Figure 1, the number of PMN submissions to OPFT has increased substantially over the past decade, from 35 submissions in 1979 (the first year in which any were reported) to a maximum of 2345 in 1988 (the drop in FY 1989 to 1150 submissions presumably reflects EPA's imposition of a proceuing fee, with submissions that might have been expected in 1989 being made in 1988 to avoid the fee). In FY 1983, the absolute number of PMN submissions nearly doubled from the preceding year (from 709 to 1342). At this time, there abo appears to be a significant inoense in the proportion of PMN submissions affected by C8I claims, relative to the preceding three years (from 70% to 79%). Definitive data are not available for overall 081 claim rates, but claims on chemical identity increase from 70% t 79%, and this higher claim rate is in subsequent years. Similar, but smaller, increases in CBI claim rates are seen for use, p--. plant site, and chemical property data. One explanation for these changes cut be found in the procedures specified by EPA for asserting CBI claims. Prior to FY 1983, EPA had an 'interim* policy that CBI claims be substantiated at the time they were asserted Cup-front* substantiation). This policy was discontinued in a notice published toward the end of FY 1982 (47 FR 28969,1/2/82) (confirmed in the Final Rale published during FY 1983; 48 FR 21722, 5/13/83). Pofymar, Lam Vobam, and To* Mart* Eaanpdam Summations EPA has separately tracked Polymer and Low Volume Exemption Submissions since FY 1985. These chemicals are presumed to be associated with a lower probability of posing substantial risks, in that polymers tend to be chemically non-reactive, while chemicals produced in low volumes should have 8 CMA 052226 correspondingly low exposure potential. As illustrated in Figure 3 (Polymer) and Figure 4 (Low Volume), a substantial number of each type of submission has been received, an average of 260 polymer submissions per year (maximum of 360), and an average of 297 Low Volume submissions per year (maximum of 592). While the rate of Polymer submissions is relatively steady, Low Volume exemption applications increased significantly in FY 1990. As is also evident from Figures 3 and 4, both classes of submission are almost uniformly covered by CBI claims (95 percent or more of Polymer submissions and between 78 percent and 93 percent of Low Volume submissions). For Polymer submissions, CBI claims relate mostly to chemical identity, with roughly half the submissions claiming submitter identity, and half claiming use information, with lower claim proportions for other key data fields. For Low Volume submissions, approximately three quarters of the submissions claim chemical identity as CBI with claim rates for other key data elements similar to those for Polymer submissions. Test Market Exemption submissions do not follow the general patten of a consistent increase in submissions, but rather show a peak in 1983 (169 submitted) and 1984 (168 submitted); the proportion covered by CBI claims is consistent, and high (greater than 90 percent for all years except FY 1985). None of the individual key data elements alone accounts for this high rate. Chemical identity, submitter identity, and use information are claimed on more than 50 percent of the forms for most reporting years. Bone Fidt Submissions If, pn the basis of a generic chemical name on the TSCA inventory, a submitter who would otherwise have to submit a PMN believes that a chemical it intends to manufacture or import may already be in commercial use, it submits to the EPA a declaration that it has a bona fidt intent to manufacture or import the chemical On the basis of this submission, the EPA is able to divulge whether or not the subject chemical b or is not on the inventory.* A moderate number of bona fidt submissions were received by EPA between FY 1979 and FY 1982 (Figure 5). There was a substantial increase in these submissions in FY 1983 and FY 1984, with some decline thereafter. Nearly all of the bona fidt submissions are affected by CBI claims, although the proportion so affected has declined since 1985. SnbmnflLEkK InfpnMfrWL gfitth o# ttffriSfgtoB As noted above, Section 8 of TSCA provides EPA with a variety of mechanisms to obtain information on the potential health and environmental risks associated with chemicals once they have entered into commercial use. Beyond the basic commercial information contained in the chemical inventory mandated by Section 8(b), EPA b provided with mandatory reporting of information indicating substantial risks (Section 8(e)), the ability to require submission of any health and safety data (Section 8(d)) or reports of significant advene reactions (Section 8(c)) that must be maintained by a manufacturer or importer, and the ability to promulgate additional rules that require recordkeeping1 1 Thb reprerents an intereating approach to the protection of business-related information, in that knowledge regarding the identity of a chemical that has bees claimed as confidential by the current manufacturer or importer b made available onfy to that company's direct competitors (those proposing to manufacture or import the same chemical). All that b reported b the fact that the chemical b in commerce. 9 CMA 052227 and/or reporting by manufa*: ; and importers (Section 8(a)). Additional information on (he provisions of Section 8 are praided in Appendix C 8(e) and FYI Submissions Under Section 8(e) of TSCA, manufacturers, distributors, and processors must notify EPA immediately if tbey obtain information indicating that a chemical presents *a substantial risk of injury to health or the environment.* As discussed in a subsequent section, legal analysts at EPA have taken the position that *health and safety data*, as specified in the statute, are not limited to the health and safety studies covered by Section 8(d). Data reported under Section 8(e) also meet the definition of a health and safety study under the Act, and are therefore subject to the limited CBI protection of Section 14(b). However, to date EPA has dealt with CBI claims on such submissions according to the general procedure, following Section 14(a). In addition to the 8(e) notices specified in the Act, EPA receives a significant number of similar submissions, termed *FYT (For Your Information) notices. These notices represent cases in which the submitter asserts that the information reported is not subject to mandatory reporting under Section 8(e). but is reported voluntarily. It could be argued that the information reported in FYI notices would more properly be incorporated into 8(e) notices; this is a matter of judgement that EPA has left to the discretion of submitters. From the point of view of CBI claims, they can be treated similarly. A key bet to remember in reviewing CBI claims for 8(e) and FYI notices is that unlike notices received under the new chemicals program, for which one can not a priori assume that a chemical poses any risk at all, 8(e) notices by definition deal with substantial risks, and FYI notices with risks of sufficient magnitude that the submitter believes EPA should be apprised of them. The number of 8(e) notices received by EPA to date has been for lower than the number of notices under the new chemicals program, with fewer than ISO such submissions in any year prior to FY 1990. Relatively few such submissions were received by EPA between 1977 and 1982 (an average of 15 per year), with the number of submissions per year jumping up to a higher level for 1983*1986 (average of 126 per year), decreasing from 1987*1989 (64 per year), and increasing considerably in 1990 (256 submissions) (Figure 6). However, the low numbers of 8(e) submissions received to date may not accurately reflect a lack of information indicating substantial risks associated with chemicals in commerce. EPA has taken the position that many submissions that should have been made under Section 8(e) were not, in fact, made. The Agency recently instituted a penalty cap program to encourage submissions of these 'missing* 8(e) notices. The announcement of this program may account for the substantial increase in 8(e) submissi ns seen in FY 1990; EPA --p--a significantly increased number of 8(e) submissions in the near future; OPFT discussions with industry have indicated that as many as several thousand may be received. One would capon, in view of the apiidt limitations on CBI claims for health and safety data contained in Secdon 14(b), that the proportion of 8(e) notices affected by CBI daims would be for less than that for new chemical submissions. The proportion of 8(e) submissions containing any CBI claims is. in fact, much lower than that seen in the new chemists program, with the proportion of CBI claims decreasing in 1963, when the absolute number of submissions first increases substantially. Of the submissions since 1983, fewer than 50 percent contain any CBI in contrast to the greater than 90 percent claim rate for PMNs. A 50 percent incidence of CBI claims, houever, is still substantial, particularly in view of the bo that these submissions deal with chemicals that have been judged to potentially present n substantial risk of harm to human health or the environment, and the foct that the burden of substantiation for CBI claims on such submissions was intended by Congress to be greater 10 CMA 052228 than for other submissions. As Figure 7 illustrates, a substantial number of the CBI claims associated with 8(e) notices concern chemical identity; moreover, the assertion of CBI claims regarding chemical identity in 8(e) notices appears to increase from FY 1985 onward. As is discussed in greater detail below, the inability of potentially exposed persons to determine the identity of chemicals that pose substantial risks severely restricts their ability to take actions to protect themselves from those risks. As is also discussed below, EPA's recent program challenging CBI assertions in 8(e) notices indicates that a substantial fraction of these CBI claims may be invalid under the statute. FY1 submissions in significant numbers are first recorded in 1987, and have remained relatively constant at ISO to 200 per year (Figure 8). Until 1990, the number of FYIs exceeded that of 8(e)s by a ratio of five to two; in 1990, more 8(e)s than FYIs were submitted (256 vs. 158). EPA staff have speculated that submitters have filed FYIs in preference to 8(e)s in order to avoid the stigma associated with a finding of "substantial risk," as well as to avoid the procedural requirements of 8(e) notification. A relatively low proportion of FYIs contain CBI claims (9 to 19 percent), but there has been a steady increase in claims from 1987 through 1990, and many of these claims concern chemical identity. These increases are of particular interest because these submissions are ostensibly voluntary. However, the proportion of FY1 submissions in which chemical identity is claimed as CBI has remained consistently lower than the corresponding figure for 8(e) submissions (10 to 20 percent vs. 30 to 45 percent over the same four yetis). Again, this may reflea the perceived stigma associated with an 8(e) submission. Significant Advent Renowns (Section 8(c)) EPA defines significant advene reactions as those "that may indicate a substantial impairment of normal activities, or long*lasting or irrevenible damage to health or the environment* (40 CFR 7173(i)). Section 8(c) of TSCA requires manufacturers, processors, and distributors of chemicals or mixtures to keep records of significant adverse reactions to health or the environment alleged to have been caused by their chemicals. Firms must nuke records of allegations available to EPA upon request. Any person who is submitting copies of these records is allowed to assert a confidentiality claim, by submitting both complete and non-confidential ("sanitized") versions of the submission (40 CFR 717.19). Almost all (21 of 26) of the 8(c) submissions requested by EPA were received in 1988. Again, one would expea a low incidence of CBI claims, because there reports satisfy the definition of a health and safety study, and would be covered by the limited CBI provisions of Section 14(b). Roughly half of there submissions to EPA contain CBI claims. There reports by definition deal with records of significant adverse reactions. When claims were made, they generally covered all key dau elements. Health and Sjety Studio Submitted Undr Section 8(4) Any manufacturer, processor or distributor of a commercial chemical must submit health and safety studies concerning that chemical that it has conducted or that are reasonably ascertainable to it (Section 8(d)). Section 3(6) of TSCA defines a health and safety study as "any study of any effect on a chemical substance or mixture on health or the environment or on both, including underlying dau and epidemiological studies, studies of occupational exposure to a chemical substance or mixture, tixbcologKul, Hiaitai, and ecological studies of s chemical substance or mixture, and any test performed pursuant to this Ao." Section 14(b) of TSCA explicitly precludes claims of confidentiality on there health and safety studies (and underlying dau), except where disclosure of the information would reveal processes used in the manufacture, importing, or processing of a substance, or, in the care of a mixture, the portion of the CMA 052229 mixture comprised by any of the substances in the mixture. Any information contained in a study which is clearly personal data (for example, individual medical records), the disclosure of which would invade personal privacy, is exempt from disclosure under FOIa as provided in Title 5, United States Code, Section 552(b)(6). Interestingly, the regulations promulgated by EPA for such submissions (40 CFR 716.55(a)(3)) appear to offer protection for CBI that are nor included in the statute, m that claims of confidentiality are allowed for company name and address, financial statistics and product codes used by a company. A Urge number of health and safety studies (more than 5,000) have been submitted to the EPA under Section 8(d) since 1986, with Urge peaks in 1987 and 1989 (Figure 9). Prior to 1990, approximately 25 percent of these contain some CBL When a CBI claim of any type is made, chemical identity is almost always claimed to be CBI (more than 96 percent of the submissions with CBI claims assert such a eUim for chemical identity; Figure 10). Substantial numbers of CBI claims were also asserted for submitter identity (provided for in the CFR). use, toxicity, exposure, and environmental release data. The exception is that in 1986 (the first year with 8(d) reporting), a very low percentage of the forms cUimed toxicity data to be CBL The key point to note is that under the explicit language of Section 14(b) of TSCA. most of these CBI claims are prime fade invalid. Congress ccpikitJy intended to make such health and safety data publicly available; doing so represents the entire rationale of Section 14(b). The only cUims that Section 14(b) permits are those that disclose 'processes used in the manufacturing or processing of a chemical substance or mixture' or, in the ose of a mixture, disclose 'the portion of the mixture comprised by any of the chemical substances in the mixture.* Even under the more lenient language of the reguUtions (40 CFR 716J5), only company name and address, financial statistics, product codes, and information that *would dearly be an unwarranted invasion of personal privacy.* Claims on use, toxicity, exposure, and environmental release data are clearly not permitted either by the statute or by regulations. CAIR Sukmisiiaia The majority of submissions under the Comprehensive Assessment Information Rule (CAIR) were received in 1989 (660), followed by 45 in 199a Fewer than 30 percent of the original submissions contain any CBI <1**^ *thf>ngh jg im nil <"*c--. it is ,,K***>^**1 identity that is claimed as CBL As CAIR reporting applies to a pro-defined set of chemicals, these CBI claims are curious. FAIR (8(a) Laml A) Sakmmitm Because data on submissions under the Preliminary Assessment Information Rule (PAIR) are maintained in a separate database, the OAFSS system contains information on only a small fraction of submissions pursuant to this rule These submissions, and CBI claims associated with them, are fo <iMn jg n subsequent in comparison to reporting of compilable information under alternative statutory authority. Accordingly, they are not considered here, except to note that a significant fraction of FAIR submiasioos contain CBI claims 12 CMA 052230 Testing of Existing Chemicals (Section 4) Section 4 of TSCA authorizes EPA to require manufacturers or processors of chemicals in commerce to test the effects of those chemicals on human health and the environment. EPA may exercise this authority by rule only upon a finding that: a particular chemical may present an unreasonable risk of injury to health or the environment; there is insufficient data available to perform a reliable risk assessment; and, testing of the chemical is required in order provide the necessaty information. (4(a)(1)(A) A finding that a chemical may present an unreasonable risk, and a consequent test rule, need not be based upon a finding that a may be toxic, bnt may rather be based on substantial production and exposure to humans or the environment, in addition to findings of insufficient data and the need for testing (4(a)(1)(B)). A test rule promulpted under Section 4(a) must: identify the chemical, include testing standards for the development of test data, and specify the duration of the testing period. The key purpose of Section 4 is the generation of studies that address the potential of identified chemicals to have advene health and safety effects. Accordingly, the results of such studies would be reported to the EPA pursuant to Section 8 of TSCA. However, Section 4(c) provides for applications for exemption from testing that would otherwise be required. EPA has received a significant number of such applications. Became test rules wider Section 4 deal with identified chemicals, many of which are in widespread commercial use, it is interesting to consider C8I claims associated with these Section 4(c) applications. Section 4(c) applications were submitted comparatively rarely between FY 1981 and FY 1986, with a significant increase in the number of submissions in FY 1987 (triple the number from FY 1986), and a noticeable peak in 1989 (Figure 11). This represents another instance of the increasing overall information processing load on OPPT staff. Prior to FY 1987, nearly all such submissions contained CBI claims. When the absolute number of submissions increased, the proportion containing CBl claims dropped considerably (in effect, the absolute number of Section 4(c) submissions with CBI claims has remained relatively constant). Again, it is notable that for a class of submission that deals with already identified chemicals that are generally in widespread use, many of the submissions with CBI claims make such claims for chemical identity. Htardoua Chemicals Identified wider the Act Once EPA finds that a Awiiai poses an unreasonable risk to human health or the environment, it has a variety of options under Section 6 to control the commerdal use of that chemical EPA may apply any of thaw options by rale *to the ectent Decenary to protect adequately against such risk using the least burdensome requirements.* Among there options are two that require the public dissemination of risk-relevant information (emphasis added): requiring that the chemical substance be labelled with dear and adequate warnings with respea to its ore or disposal and, t requiring manufacturers or processors of the chemical substance or mixture to provide notice of unreasonable risk of injury to anyone who may come in contact with the chemical substance, to give public notice of such risk and to replace or repurchase the chemical substance or mixture, whichever is chosen by the person to which this requirement is directed. 13 CMA 052231 One class of chemicals, polychlorinated biphenyls is explicitly addressed in the statutory language of Section 6(e). Section 6 also provided the Admntstrator with the authority to promulgate rules regulating other chemicals and chemical classes. Much of the Agency's efforts to date have been focused on regulating asbestos (see Appendix D). Section 6 Submissions There is no routine reporting to EPA required under Section 6, hut OPPT has logged a significant number of documents sent to it under this part of the statute, ranging from 13 in FY 1981 to 202 in FY 1987. As Figure 12 indicates, the number of submissions to EPA significantly increased from 1980 through 1988, with a subsequent decrease in 1989 and 1990. Through 1986, almost all of these submissions contained CBI assertions, but the proportion with such claims has dropped steadily from 1986. Again, a significant fraction of the CBI assertions concern chemical identity (nearly all since 1987). As in the case of Section 4 reporting, this inspires curiosity, because these submissions presumably deal with identified substances that have been the focus of public rulemaking. Chemical Inventory Resorting As noted earlier. Section 8(b) of TSCA required EPA to compile, maintain, and publish a list of the chemical substances which are manufactured or processed in the United States. Any substances not listed in the inventory are subject to premanufaaure notice requirements under Section 5, and are added to the inventory as they enter commerce. Chemical substances which are manufactured, imported, or processed in small quantities solely for the purpose of scientific experimentation or analysis or chemical research for the development of a product are exempt from reporting to the inventory (40 CFR 710.4 (b)(3)). The initial inventory was compiled in 1977. Reporting under Section 8(b) provides for CBI claims n the following types of information (40 CFR 710.7): company name; site; chemical identity; whether the chemical substance is manufactured, imported, or processed; whether the chemical substance is manufactured and processed only within one site and not distributed for commercial purposes outside that site; and, the quantity manufactured, imported or processed. Written substantiation was required for claiming chemiol identity as confidential; all other claims could be substantiated by simply the CBI box and then attesting to the claims made by providing a signature on the form. To daim the chemical identity as confidential, businesses were required to complete, sign, and submit EPA inventory report Form C (EPA Form No. 7710-3C) (40 CFR 710.5 0>)(7)). Inventory Dm A review of CBI identification fields in the Chemicals in Commerce Information System (CICIS) indicates that the initial compilation of the TSCA inventory was significantly less affected by confidentiality ehiim than recent submissions to EPA tend to be. Of the 141,018 records for which information on CBI flair"* is available (data flags are missing on 3.6 percent of the records), CBI claims 14 CMA 052232 range from a low of l.S percent (2,608.records) with the 'site-limited* field indicated as CBI. to a nigh of 27.2 percent of the records (39,742) for which production volume was claimed to be CBI. For most data fields, roughly 10 percent of the records indiate an assertion of confidentiality Summary of CBI Claims Since FY 1982, there has been a massive and increasing number of CBI claims affecting information submitted to the EPA under TSCA. In pan, this reflects a nearly exponential increase in the number of documents submitted to EPA under the statute. Much of this increased information load has come through the new chemicals program under Section 5 (PMNs and related submissions), but significant increases have also been seen for substantial risk (Section 8(e)), FYI, and other health and safety related submissions, including health and safety studies submitted under Section 8(d). Even programs that do not require routine reporting, such as the Section 6 regulatory program, have generated Urge numbers of submissions in recent years. To a lesser extent, the increase in the number of CBI claims reflects changes in CBI cUim patterns from the early yean of TSCA to more recent times, such as the increase in CBI cUims on PMN submissions after the `up-front* substantiation requirements were dropped. Those submissions under Section 8 that deal with health and safety studies and findings of subsuntial risk would be expected to have a much lower frequency of CBI daims than do submissions under Section S, because they are subject to the stricter limitations of Section 14(b). These submissions do have a lower proportion of CBI claims than is seen in the new chemicals program, but there are still a significant number of CBI claims affecting these submissions. This number is far in excess of what might be expected on the basis of the specific limitations imposed by Section 14(b) on CBI daims regarding health and safety studies. For 8(d) submissions, numerous CBI daims are being asserted on data elements (such as chemical identity) that appear to be preduded from such daims under Section 14(b). The high rate of CBI daims in submissions since 1979 stands in stark contrast to that seen for the dau in the original inventory. More than 90 percent of the PMN data are covered by CBI claims, while less than 30 percent of the records in the original inventory are affected by such daims. CBI daims have decreased is some areas in recent years. For example, daims on submitter identity for PMN, bona fide. Section 4(c), and Section 6 submissions decreased between 1986 and 1990. Unfortunately, these deceases in on submitter identity have been offret by increasing daims on a more critical data element, chemical identity. A significant concern is the increase in the proportion of 8(e) (substantial risk) notices, and related FYI notices, in which the identity of the chemical is claimed as CBL Overall, the decrease fat some specific claim types is dwarfed by the general increase in CBI Taken together, the increase in CBI daims in the new cbemkab program and the significant numbers of daims affecting other submission types (particularly under Section 8, where the statute restricts daims) suggests that there may be a significant number of CBI daims that are not valid under the statute. The next section of the report addroses the procedures used by EPA to review CBI claims and ensure that they are properly substantiated. 15 CMA 052233 substantiation and review of cbi claims As the previous section has shown, the number and scope of CBI claims made for information submitted to EPA under TSCA is extremely large. This huge volume of CBI. taken together with the increases over time seen in CBI claim rates and the relatively high claim rate on submissions subject to the strict provisions of Section 14(b), suggests that a significant fraction of the CBI claims that have been made may not be necessary to protect true trade secret information and may not be valid under the statute. Although TSCA and its implementing regulations specify explicit requirements regarding the substantiation of CBI claims under TSCA, OPPT does not routinely require submitters to substantiate claims. The penalties for wrongful disclosure are far stronger than those for making invalid claims, and OPPT resource limitations mean that only a small fraction of submissions can be reviewed and/or challenged. Where OPPT has had the resources to challenge CBI claims, these claims are regularly withdrawn. Statutory Criteria for Reviewing CTilmi As specified in its regulations (40 CFR 1203 a stq.), EPA must make a preliminary determination as to whether or not the business information is entitled to confidential treatment when responding to Freedom of Information Act (FOIA) requests, or if it is likely that EPA will be required to disclose the information at a future date. EPA is also authorized to review any claim that has been submitted, in order to ensure that it complies with TSCA and its implementing regulations. Business information is entitled to confidential treatment if (40 CFR 2208): 1) The business has asserted a claim which has not expired by its terms, nor been waived nor withdrawn; 2) The business has satisfactorily shown that it has taken reasonable measures to protect the confidentiality of the information, and that it intends to continue to take such measures; 3) The infonnation is not, and baa not been, reasonably obtainable without the business's consent by other persons (other than governmental bodies) by use of legitimate means (other than discovery based on a showing of special need in a judicial or quasi-judicial proceeding); 4) No statute specifically requires dtadosure of the infonnation; and either a) the bosfaea has satisfrctorily shown that disclosure of the infonnation is likely to cause substantial harm to the business's competitive position; or b) tbe information is voluntarily submitted and its disclosure would be likely to impair the government's ability to obtain necessary information in the future.* When responding to a FOIA request, this determination must be made within a 10 working-day period. Under 40 CFR 2205(a) EPA*s legal office (defined ss the Office of General Counsel in 40 CFR 2306(e)) is responsible for the final determination on confidentiality. If a claim is reviewed, EPA offices attempt to obtain the affected business's consent to disclose useful portions of records while protecting the information which may be entitled to confidentiality (eg., by withholding such portions f * These criteria apply only to information that has not been explicitly excluded from protection as CBI because the constitute health and safety dau (40 CFR 2306). 16 CMA 052234 a record that would identify a business, or by disclosing data in the form of industry-wide aggregates or totals, or some similar form)(40 CFR 2.202(0). Under 40 CFR 2.205(0(2). if EPA determines that the information is not entitled to protection as CBI, then the EPA office taking action on the claim and the Office of General Counsel issues a notice of denial (by certified mail) stating the basis for the determination and that the decision constitutes final Agency action. The information is made available to the public on the 31st calendar day after the date of the business's receipt of the written notice, `unless the EPA legal office has first been notified of the business's commencement of an action in a Federal court to obtain judicial review of the determination, and to obtain preliminary injunctive relief against disclosure* (40 CFR 2.205(f)(ii)(2. Any prior determinations of confidentiality may be changed due to changes in facts or law, or because the earlier determination was clearly erroneous (40 CFR 2.205(h)). SttSytoqiPTBtUtff far CBI As previously noted, the statute assigns no penalties to companies that submit false or invalid CBI claims. Strict penalties are, however, specified for any EPA staff or contractors that reveal confidential information. When TSCA CBI is wrongfully disclosed it is treated as a misdemeanor. Under Section 14 wrongful* disclosure occurs when an authorized person in possession of CBI material is aware that disclosure is prohibited and intentionally discloses the CBI material to aa unauthorized person. Anyone guilty of wrongful disclosure may be subject to a fine of not more than 15,000 and/or not more than one year of imprisonment (Section 14(d)). Wrongful disclosure of CBI by an EPA employee can also be grounds for rftmfrMi, suspension, fine, or other adverse personnel action. Intentional disclosure could also result in criminal prosecution (40 CFR 2Jll(c)> like Code of Federal Regulations also sutes that any authorized possessor of CBI must take 'appropriate" measures to properly safeguard the information and to protea against its disclosure. Resource Considerations and Actual Practice Given the vast number of CBI claims received by EPA, it is impossible for EPA staff to review each claim thoroughly to determine its validity, and, at the same time, process the claim in an expeditious manner. The result Is that actual practice differs from what the statutory and regulatory language would lead one to expect. Although the statutory language places the burden of establishing the confidentiality of information upon the submitter, and provides the Agency with the ability to disclose information not properly protected by the submitter, the obligation of the Agency to protea legitimate CBI, and the imbalance in penalties for wrongful disclosure aa opposed to invalid claims, has lead OPPT to go to considerable lengths to protea any claimed CBI from disclosure. For example, OPPT staff indicate that it is a common practice so review the sanitised* copies of CBI documents, so that submitten can be notified of inadequate attempts at sanitiatioix, rather than simply ptaring the ***|th*4 copies in the public docket. While EPA is required to notify submitters of inadequate sanitation it has detected, there is no obligation to documents for this purpose. In practice, ocept for the 8(d) / 8(e) Challenge Program and challenges at the time a Notice of Commencement is received, the vast majority of claims submitted are not reviewed. Unless OPPT staff have information that lends them to believe the claim is invalid, the claim is not reviewed. Indeed, it is not Agency practice to even request submission of substantiation materials for CBI claims. OPPT employes noted that they generally request substantiation of a CBI claim only when a FOLA request for release of the information has been received. Only when a persistent requestor insists upon release of the dau is the submitter contacted to substantiate the claim. 17 CMA 052235 Submitters Amend CBI Claims when Challenged For the past year, OPPT has reviewed each 8(d), Health and Safety Study, and 8(e), Notice of Substantial Risk submission, and has elected to challenge submiuen to substantiate a significant number of CBI claims affecting such notices.1 Between September 1990 and May 1991, 106 8(e) submissions were reviewed and 52 (49 percent) were challenged. Over the same period, 351 8(d) submissions were reviewed, and 77 (22 percent) were challenged. In essence, all CBI claims associated with these submissions have been challenged. The Cm that, in every ease to dau, the submitter has amended the submission when challenged, indicates that EPA is correct in challenging the validity of these CBI claims. In many cases, the invalid CBI claims appear to cover information that is potentially embarrassing to the submitter, but not entitled to protection under eit/ur Section 14(a) or Section 14(b). Rather, the effort is to prevent disclosure of precisely the sort of information the framers of TSCA wanted made public For sample: One submitter claimed its identity, and the identity of the chemical substance, as CBI, because they were concerned that potential customers would interpret toxicity dau repotted in an 8(e) notice in such a way as to conclude the substance was unsafe (the submitter believed this to be a misinterpreution). Notwithstanding the submitter's desire to put n *spin* on the study, these dau, including the identity of the chemical, ate precisely the son of information that the framers of TSCA sought to make available to the public. . in a case, the submitter wished to withhold its identity (which included the name of the subject chemical), as well as the chemical identity, because it believed that effects seen in a toxicity study were not compound-related. Again, TSCA explicitly includes the data from toxicity studies in its reporting standards, and does not permit regulated persons to submit only their interpretation of a study. The submitter of this study had ample opponunity to defend its judgement that the effects were not caused by the chemical, and could have made a convincing case, but instead chose to make an invalid CBI claim. In one cue, the submitter made e CBI claim on its identity, and that of iu trademarked commercial produa, on an 8(e) documenting advene health effects in workers exposed to an apparent breakdown product, produced under unusual circumstances. Again, the submitter could have made public the very limited conditions under which such an advene effect occurred, as well as the fact that it appeared to have made didgetu efforts to ensure that such effects would not occur again, and yet instead chose to nuke an invalid CBI daim. Yet another eample dealt with a study that identified inadequacies in the medical surveillance program of a submitter. The submitter's identity and plant location were claimed CBI. There aeemed to be no evidence that the bet that the submitter used the chemical at that fecility was an uudarinsed trade secret. Rather, b might reasonably be inferred that the submitter wished to avoid embalmment regarding the inadequacy of its occupational health program, or to foresail difficulties with bs work force. 1 Discretions with OPPT staff indicate that a number of factors, beyond the presumptive validity of the CBI daim, are considered in deciding whether or not to issue e challenge. Accordingly, it would not be appropriate to infer that the fraction of CBI claims that is not challenged represents valid CBI claims CMA 052236 . A recent 8(e) submission, claimed as'CBI, was an EPA Order filed under CERCLA. The Order noted, as a Finding of Fact, that a particular facility and its surrounding area had been contaminated by a hazardous substance manufactured by the submitter/respondent. Also noted were the facts that the submitter and others would initiate a cleanup, and that local shellfish had been contaminated. The submitter claimed both company identity and chemical identity as CBI, even though the original EPA Order was not claimed as CBI, and therefore the information was available. Following negotiations, the submitter dropped all CBI claims on chemical identity. In another 8(e) filing, a submitter claimed submitter identity and chemical identity as CBI, because it considered the health effect it was reporting to be *highly unusual,* and believed that release of the information prior to conducting additional research might ause `premature and possibly unnecessary concern.* This represents yet another example of a CBI claim used not to protea commercial information, but rather to conceal oactly the information that Congress intended to make public by way of 8(e) submissions. Lastly, a submitter provided the final draft of a study of the effects of working for prolonged periods with particular chemicals. This draft study had been provided to union representatives of the submitter's workers prior to submission to the Agency. Despite the fact that all of the relevant information had thus been made public, the submitter claimed company name, union name, plant sites, and chemical identities as CBL Following discussions with EPA, the submitter agreed to drop all CBI claims for chemical identities immediately, and to drop all other claims once the final report bad been filed with the Agency. To the extent that these examples are typical, they illustrate an apparent reliance on CBI claims to avoid embarrassment or adverse public reaction, rather than to protea trade secret information from competitors. However, TSCA was enacted precisely to facilitate informed decision-making by the public, such that market forces could lead to the replacement of unsafe chemicals with better alternatives. Invalid claims of the type described above subvert a fundamental goal of the statute. Although EPA has had tremendous success in challenging inappropriate claims, these challenges have placed strong demands on Agency resources. While some challenges (very few) may require as little as a single five-minute telephone cu, others have consumed as much as 40 person-hours. OPPT staff indicate that the majority can be dealt with using two hours of staff time. Thus this effort, dealing with a type of submission of which the Agency generally receives fewer than 200 per year, requires a major investment of effort by OPPT staff. More extensive challenging of submissions does not appear, therefore, to be feasible for all sections of TSCA. For cample, there are approximately 10 times as many PMNs a there are 8(e) notices submitted in the average year. At present, OPPT simply lacks the staff resources to challenge all of these. Given the exported massive increase in 8(e) submissions under EPA's ^penalty cap,* it is not dear that OPPT wQl be able to maintain its comprehensive challenge program for these submissions. It is impassible, without an ongoing review of other TSCA submissions, to know the degree to which the pattern of inappropriate C8I efafam seen in 8(d) and 8(e) notices is typical of other types of information submitted to EPA. The feet that such claims are made in submissions that explicitly deal with substantial risk, however, b not encouraging. 19 CMA 052237 SIMILAR DATA ARE NOT CONFIDENTIAL UNDER RELATED STATUTES The statutory and regulatory language clearly provide EPA with the ability to deny invalid confidentiality claims. However, they also specify a very broad range of data that may be entitled to protection as CBL This places the Agency in the position of having to decide whether any particular CBI claim is in fact valid. As the preceding section shows, in those instances where EPA has challenged the validity of claims, the claims have proven not to be valid. Without examining each claim individually, it is not possible to conclude that a majority of CBI claims are invalid. However, a comparison of data collected under TSCA with similar data collected under another statute with less liberal confidentiality provisions indicates that CBI claims under TSCA are far in excess of what is needed to protea true trade secrets. More recent sututes have taken a narrower view than does TSCA of the types of information that are potentially subjea to confidentiality claims. For example, TSCA provided EPA all the authority needed to coUea information substantially identical to that reported and made public on the Toxics Release Inventory (TRI) under the Emergency Planning and Community Right to Know Act of 1986 (EPCRA) and the Federal Pollution Prevention Act of 1990. However, these tatter statutes contain provisions governing public disclosure of the data and information reported to EPA that differ from those in TSCA in important ways.* These differences are apparent when comparing reporting under TSCA's Preliminary Assessment Information Rule (PAIR) with reporting to TRL Reporting under these two statutes is similar in that 1) both deal with pre-defined sets of chemicals, and 2) PAIR requires reporting on the quantity of chemical lost, while TRI requires reporting on release to the environment The reporting on releases to the environment for TRI is actually considerably more detailed than the loss reporting required under PAIR. TRI reporting differs from PAIR reporting in that confidentiality claims for TRI are much more restrictive; claims can only be made for chemical identity, and TRI has explicit provisions to discourage frivolous a requirement that the submission he reviewed and signed by a top corporate official; a requirement that all trade seaet at the time that they am made; be accompanied by information to substantiate the claims, . i limitation that only chemical identity can be claimed a trade secret,* thereby releasing the test of the content of the reporting form to the public, including the identity of the claimant and the magnitude of any releases and transfers (thus, there is potential public accountability for any trade secret claims befog made); 1 Indeed, TRI-tike dam have been reported for several hundred chemicals under TSCA since the early 198CTt, bet in contrast to TRFs programs of active public disclosure, the same data under TSCA have been held by EPA in confidential databases. * Under TSCA, it is possible to claim chemical identity as CBI in a submission that is not a health and safety study. Although identity is essential to the full undemanding of such studies, it has not been EPA practice to challenge CBI claims on chemical identity, even when the submission was a health and safety study. A few interviewees indicated that precise chemical identity information was not needed to interpret these studies, although the majority did not endorse this view. 20 CMA 052238 . penalties (comparable to those imposed under TSCA on government employees who release TSCa CB1 data) for corporate officials malting a false trade-secrecy claim under EPCRA It is impossible to tell the extent to which each of these four provisions individually is resulting in the insignificant number of claims of trade secrecy under EPCRA. What is clear, however, is that the combination of these four policies results in a dramatic decrease in the number of trade secret claims being received under EPCRA as compared to TSCA For the 1988 TRI data, there were only 23 trade secret claims, out of more than 70,000 TRI forms. To obtain a more direct comparison between PAIR and TRI reporting, a subset of 37 chemicals were selected on which reporting was required under both PAIR and TRI, and for which at least one report had been made for both. Using this subset eliminates discrepancies attributable to differences in the particular chemicals subject to reporting. Because PAIR affects a narrower class of potential submitters than does TRI, statistics were obtained not only on overall TRI reporting for these chemicals, but also for submitters who indicated (in the use ategoty of the TRI reporting form) that they were producers or importers of the chemical being reported. Thus, one can be assured that there is significant overlap between the facilities reporting under PAIR and under TRI. Table 1 presents the summary data for these chemicals. There were a total of 13,164 TRI facility reports for these 37 chemicals in 1988, 463 of which represent producers or importers of tbe chemicals. As noted above, only a tiny fraction (0.03 percent) of the TRI forms are affected by trade secret claims; even if all of these claims affected the 37 chemicals selected, tbe claim rate would be less than 0.17 percent If one makes the even less plausible assumption that all of the confidentiality claims not only concern these 37 chemials, but also were made by producers or importers, tbe claim rate is less than 5 percent For tbe same set of chemicals, there were 302 PAIR forms submitted. This number is on the same order of magnitude as the number of produoersfimporten reporting to TRI, although it is substantially lower (35 percent fewer forms). Tbe difference may reflea tbe fret that tbe threshold quantities for reporting under PAIR are higher than those under TRI; fsdlities with quantities foiling between the two thresholds may account for these ; forms. Although the specific information that can be claimed as CBI on PAIR forms differs from what an be claimed as confidential on TRI forms, these claims an be quantitatively compared as equivalent types of information. (On PAIR forms, claims an be made for 'quantity lost', while on TRI forms the quantity released must be reported and it is the identity that may be claimed as a trade secret.) Using the subset of 37 demonstrates that over 50 percent of the PAIR forms had CBI claims. When compared to the HU confidentiality claims (XD percent of all HU forms), the CBI claim rate under PAIR is more than 1,500 limes higher than the trade secret claim rate under TRL Even if one makes the very unlikely assumption that all of the TRI trade secret claims are contained on those forms in the subset, CBI claims under PAIR are being made at 10 times the rate of trade secret claims under TRL* * This is admittedly a wide range of passible claim ratios. The difficulty in narrowing this range arises from the very limited number of trade secret claims made for TRI data. OPPT staff indicated that supplying any data on the number of these claims affecting the chemicals used in this comparison might compromise the security of the trade secret data. 21 CMA 052239 These data sir . suggest that the CB[ claims made under PAIR are far in excess of what is truly required to safegt*. trade secrets. They also suggest that if the restrictions on CB1 claims under TSCA were tightened to ru-umble those of EPCRA the proportion of submissions affected by CBI claims would drop substantially. Moreover, the comparison above suggests that many of the CBI claims on chemical loss data made under PAIR are no longer valid, if in fact they ever were. The existence in the public record (TRI) of substantially identical information would invalidate the CBI claims. It may not be appropriate to make a quantitative extrapolation from the analysis of PAIR data to reporting under other provisions of TSCA However, the data do support the conclusion that CBI claims under TSCA would not meet the requirements for trade secret claims under EPCRa and that more stringent requirements for substantiating CBI claims could have the effect of reducing the proportion of TSCA data coveted by such claims. 22 CMA 052240 LEGAL AND TECHNICAL CONSIDERATIONS The preceding section illustrates the extent to which statutory controls on frivolous confidentiality claims can influence the number of such claims that are made. Under TSCA's lenient CB1 provisions, far more claims are made than under the stria provisions of EPCRA It has not been demonstrated that the more restrictive confidentiality provisions of EPCRA have resulted in competitive harm to any submitter. Recent analyses by legal staff in EPA's Office of Pollution Prevention and Toxics indicate that Agency practice in accepting CBI claims has, in fact, been more lenient than the statute (or its implementing regulations) requires. As was noted above, while Section 14(a) of TSCA does not restria confidentiality on a wide variety of information submitted to EPA, Section 14(b) narrowly restricts CBI on information from health and safety studies." For such health and safety studies, the only prohibitions on public release of information are on data that disclose 'processes used in the manufaauring or processing of a chemical substance or mixture or, in the case of a mixture, releasing any data which discloses the portion of the mixture comprised by any of the chemical substances in the mixture1 Moreover, the statute incorporates a broad definition of a health and safety study (TSCA Section 3(6)): The term *health and safety study* means any study of any effea of a chemical substance or mixture on health or the environment or on both, including underlying dau and epidemiological studies, studies of occupational exposure to a chemical substance or mixture, toxicological, and ecological studies of a chemical substance or mixture, and any test performed pursuant to this Acl This language is quite broadly inclusive. Moreover, EPA, in developing regulations on reporting health and safety data, has noted that Congress did not intend to restria the definition to formal studies: It is intended that the term (health and safety studies) be interpreted broadly. Not only is information which arises as a result of a formal, disripUned study included, but other information relating to the effects of a chemical substance or mixture on health and the environment is also included. Any data which ns on the effects of a chemical substance on health or the environment would be included. (nJL Rep. No. 94-179,94th Cong., 2nd Sess. 58 (1976) (Conference Report), as died in 47 FR 38782, September 2, 1982.) Thus, the statute would appear to automatically disallow many CBI claims that have gone unchallenged by EPA until reoently. This is particularly true of hey data elements such as the identity of chemicals for which health and safety dam have been reported under Section 8(d) (health and safety studies) and Section 8(e) (notices of substantial risk). As noted by OPPT attorneys, data that allow a determination of tubstintial risk inherently meet the statute's definition of a health and safety study. These considereiions have lend SPA recently to institute a program of routine challenges to CBI claims on these submhnfons. The sections of the Code of Federal Regulations that implement TSCA follow the statute both in restricting the range of CBI claims that out be made for health and safety studies and in defining such studies broadly, b particular, as OPPT attorneys have pointed out, chemical identity can only be claimed confidential in a health and safely study when the submitter can demonstrate that knowledge of11 11 ` The regulatory language implementing these provisions of the sutute can be found at 40 CFR 2.203 et seq., and at 40 CFR 2J06. 23 CMA 052241 identity per se is sufficient to disclose a process of manufacture or portions of a mixture, a condition that would almost never be true. Information from health and safety studies is submitted to EPA not only under Section 8 of TSCA. but also under Sections 4 and S. It is particularly worth noting that since PMNs mutt include any health and safety data known to, or reasonably ascertainable by. the submitter, a substantial fraction of PMN submissions would be subject to the stria CBI provisions of Seaion 14(b). This would mean that the broad CBI proteaion currently extended to entire PMN submissions would be dropped from those portions of each submission that constitute health and safety data. Only those PMN substances for which no health and safety data were available would be eligible for the broad protection currently being afforded to all PMNs. This is likely to be a relatively small subset of PMN submissions. Moreover, EPA scientists could easily support the argument that such submissions would be subject to regulatory action under Section 5(e), for lacking adequate information to permit a determination of risk. There is an explicit exemption provided for data that are not necessary to interpret the health and safety study data. OPPT attorneys have argued that it is rarefy the case that chemical identity information could legitimately be covered by such an exemption. It is unlikely that any reputable health or environmental scientist could be found who would argue that it is ever the case that chemical identity is unnecessary to interpret health and safety data. This reasoning leads to the conclusion that a significant amount of information that EPA has received over the past decade, and has protected as CBI (ct Figures 7 and 10), is not in faa entitled t such protection under the statute. It is also true that in order to be protected under Seaion 14(a) of the statute, the information (from a source ether than a health or safety study) must be of such a nature that if revealed, it would cause substantial competitive harm to the submitter (40 CFR 2208). As noted above, the statistical analysis of CBI claims indicates that many iubmissions contain multiple CBI One can question the extent to which, in such cases, it is necessary to protect all of the information claimed as CBI in order to preserve the submitter from substantial competitive harm. For example, if the key cooumtial information is that a particular chcmlal substance has a certain use, ne could safeguard this information by either the identity or the use as CBI; there would be no need to protea both items of information as CBL Because EPA has generally lacked the resources to evaluate each submission in the past, it is possible that many of the subminions containing multiple CBI * are in fact making ***<-- beyood those necessary to protea the submitter from substantial competitive harm. It appears that if EPA applied stricter standards to CBI claims, which could be done under existing regulations, and had the mourcas to review claims, a significant fraction of the claims would be dropped. It also appears likely that if procedures for submitting CBI claims under TSCA were made m re onerous, as they are under other statutes, fir fewer CBI claims would be made in the first place. 8 As noted above, under Section 14(b), chemical identity is not entitled to proteaion as CBI when it forms pan of a health and safety study. 24 CMA 052242 CONSEQUENCES OF CURRENT CBI CLAIM AND REVIEW PRACTICES A series of interviews with EPA employees, both within and outside of OPPT, officials in other federal agencies with a potential need for access to TSCA CBI, state government employees familiar with TSCA data, and representatives of non-governmental organizations including environmental groups and labor unions, elicited a wide range of opinions on both the nature and extent of the problems posed by TSCA CBI practices. In general terms, interviewees tended to concentrate on two separate problems posed by current CBI practices. Those within OPPT were generally, although not exclusively, concerned primarily with the volume of CBI, and its implications for the use of their limited resources. Those outside of OPPT were primarily concerned with more limited data sets that CBI claims had rendered unavailable to them. In order to address the concerns identified by OPPT staff, a significant reduction in the absolute number of CBI claims would be required. For outside data users, concerns could sometimes be by eliminating CBI claims on a very limited data set (eg. claims on chemical identity in Section 8(e) notices). The particular data set for which declassification was desired varied among the interviewees. CBI Presents a Logistics Challenge for EPA CBI Security Pnaduns an Stria The statutory language of TSCA, and the regulatory language implementing it, specifies the types of information submitted under TSCA that can be claimed as CBI, as well as the circumstances that determine the legitimacy of CBI claims. Neither the law nor the regulations, however, contain any detailed information regarding procedures employed to safeguard TSCA CBL These are covered by guidance documents developed by OPPT. These guidance documents, and the procedures described in them, were developed in the context of two lawsuits brought against EPA by Polaroid Corporation, which were settled in 1985 by means of consent agreements. The consent agreements incorporate the security requirements in the guidance documents by reference, and require that adequate public notice be given by the Agency prior to implementing any significant changes in security procedures, and contemporaneously with the implementation of any substantive changes. The guidance documents developed by EPA establish a controlled environment for TSCA CBI material to ensure that a complete audit trail remains as to the location of any document at all times and the identity of the person responsible for the document if it has been removed from the Confidential Business Information Center (CBIC). Appendix E describes the procedures which EPA staff, contractors, and subcontractors must follow to safeguard CBI materiiL It is the consensus of the EPA staff interviewed for this report (including several staff involved in developing CBI security procedures) tint the level of protection provided for TSCA CBI is equivalent to that provided to information deemed *Xeoef tor national security purposes. Thus, the level of protection afforded TSCA CBI exceeds any icmonably foreseeable threat CBI Security Pi erring an Effectin There is ample evidence that CBI security pnmsions are quite effective in preventing the release of CBL No case has been documented in which CBI was intentionally disclosed, and the number of cases of accidental disclosure is quite Fewer than two dozen instances were identified in which procedural violations were of such a nature that they were likely to result in disclosure of CBI to unauthorized persons, such as mailing materials containing CBI to the wrong submitter or discussing CBI 25 CMA 052243 at a public meeting (details are provided'in Appendix E). No one has ever demonstrated that an> competitive harm has come to any submitter from the disclosure of CBI. It has been argued, bom b> EPA staff and outside observers, that the degree of protection afforded to TSCA CBI is. in fact, disproportionate to the threat of wrongful disclosure. As noted below, EPA is exploring options to decrease unnecessary burdens on users of TSCA CBI, without lessening protection against realistic threats to CBI security. CBI Security Entails Direct and Indirect Costs Safeguarding information subject to CBI claims imposes significant costs on EPA's Office of Pollution Prevention and Toxics, including staff efforts involved in CBI security procedures, whether directly or by requiring extra efforts in processing information that is needed to perform regulatory review, as well as explicit expenditures for security, duplicative information systems ranging from PCs to mainframe computers, and extensive background investigations on individuals who must have CBI access to do their work. It is difficult to quantify the costs to EPA of CBI security provisions, as many of the expenses entailed in maintaining CBI security are not accounted separately by OPPT. In addition to security staff. Document Control Officers, and Document Control Assistants within OPPT at EPA headquarters, staff in the regional EPA offices and EPA laboratories devote significant efforts to ensuring the security of TSCA CBL No separate rental figures are available for office space used to provide CBI secure areas, nor is there separate accounting for CBI-approved storage containers, special locks and electronic access control systems, or duplicate computer systems and computer security software. Neither is it possible to quantify the cost of not being able to use low-cost grantee writers for tasks involving CBL Moreover, CBI imposes significant changes in the work environment of OPPT staff. Routine work activities such as casual Tullway* discussions with colleagues, reviewing documents while riding the Metro to work, taking notes at meetings, or writing a memo on the common office word-processor become essentially impossible when CBI is involved. Instead, discussions must be held (only with . colleagues who have CBI clearances tot the particular section of TSCA) in secure areas where there is no chance of being overheard, documents cut be reviewed only in secure environments, meeting notes themselves become CBI documents and must be logged and guarded under lock and key, and computers must have their memories and permanent storage media over-written after processing CBI. Even typewriter ribbons must be secured until they are destroyed. The internal cost savinp that EPA could realize with rrepect to its regulatory efforts from decreased CBI claims under TSCA depend critically not only on the extern of any reduction in claims, but also on the patterns of reduction. An ffiustntive example is provided by the new chemicals (PMN) program. As has been shown above, moat PMN submissions entail multiple CBI claims It does not appear to be unusual for a PMN to have half a dozen or more CBI claims. If each such document contained only a single claim (a redaction in total claims of more than 80%), the document would still have to be protected using procedures substantially similar to those that umuld apply without any decrease in CBI claims. Only in the ose where substantial numbers of PMN submissions were entirety tree of CBI claims would a reasonable possibility exist for freeing staff and resources from CBI procedures. The situation seems more hopeful in other program areas, where a smaller fraction of submissions are affected by CBI claims. In these programs, any substantial reduction in the proportion of submissions affected by CBI claims might enable the program to be run in a manner generally free of CBI considerations and constraints; a small subset of program staff and fodlities could address the limited number of CBI-tainted submissions. 26 CMA 052244 OPPT is Improving its Efficiency in Processing CBl In addition to its efforts to reduce the amount of information for which invalid CBI claims arc made. OPPT has initiated several efforts to increase the efficiency with which it processes CBI material, and thus reduce the burdens imposed by the need to safeguard CBI. For example, a pilot program is explonng the use of an optical disk information storage system that would enable OPPT staff to review submissions with fewer paper documents. This would both facilitate efforts to track access to CBI. and reduce the risk of inadvertent disclosure through misplacement of documents. OPPT is also negotiating with industry to have submitten prepare all of the copies of CBI documents that OPPT requires for its review process. This would reduce the equipment and staff costs involved in assuring-security while copying CBI materials. EPA is exploring possibilities for reducing CBI security procedures that do not provide meaningful protection against realistic threats of CBI disclosure. For example, encryption of dau exchange lines for Local Area Networks (LANs) contained entirely within space controlled by EPA may not be required, even if such dau lines pass through areas that have not been designated as CBI secure areas; the protection provided by dedicated eiectrial conduits is considered sufficient. The threat of an intruder being able enter EPA-controlled space, up into such dau lines, and obuin meaningful disclosures of CBI, is simply not a realistic one. EPA is strongly considering changes in Its procedures that would fadliuie granting employees and contractors access to TSCA CBI submitted under several sections of the law. While the Polaroid consent decree requires that access to TSCA CBI be granted on a section-by-section basis, the nature of information review involved in administering OPPT regulatory programs is such that most suff will require access to information submitted under multiple sections of TSCA For example, a routine feature of PMN review by the Agency is a search of 8(e) and FYI submissions for risk-relevant information on compounds that are structurally to the PMN compound. Procedural changes in this area could eliminate considerable unnecessary administrative overhead. EPA Coos Associated with tmaBi CBI Claims Interviews with EPA staff revealed a variety of perceptions regarding both the proportion of CBI claims that are invalid under TSCA and the impacts of such invalid claims on EPA's effectiveness in administering the law. Some asserted that invalid claims were a serious problem, with a number of outrageous abuses occurring, while others maintained that CBI requirements were serving as a scapegoat for overall OPPT resource limitations, interviewees also expressed a wide variety of views on the extent to which CBI procedures reflected the institutional culture or EPA, as opposed to being required by the statute. In general, opinions on the number and consequences of invalid CBI claims tended to be correlated with each interviewee's role in the CBI process. Those involved in the promulgation of regulations regarding CBI, or in implementing procedures to ensure the security of CBI, were more likely to be convinced that the bulk of CBI claims were legitimate, and to minimize the advene impacts associated with invalid daims. OPPT staff who required access to CBI in order to review the risks posed by chemicals were for more likely to consider the number of daims excessive, and to relate cases of egregiousiy inappropriate CBI daims. Their views were shared to a considerable extent by OPPT suff involved in efforts to disseminate dau to other federal agencies, state governments, and the public Another area where a wide range of opinions existed concerned the utility of generic information supplied for public dissemination when specific information was claimed as CBI. To some extent this varied according to the type of information; it also reflected the quality of the generic information 27 CMA 052245 supplied. For example, a number of interviewees (although not all) indicated that adequate generic chemical identity information would be almost as useful as specific chemical identities that are generally covered by CBI claims; however, almost all indicated that the generic chemical identity information currently supplied by most submitters was essentially useless. A significant number of interviewees indicated that for data on environmental releases, production volumes, and other exposure-relevant information, order-of-magnitude range estimates might be nearly as useful as precise values. As noted above, the available evidence indicates that many CBI claims were invalid at the time they were asserted. A somewhat different problem is presented by claims that were legitimate at the time they were asserted, but that have been rendered invalid by subsequent events. There mas a widespread consensus among interviewees that this description might apply to a significant fraction of the material being safeguarded as CBI by EPA Although opinions differed regarding the extent to which one could establish, a priori, a sunset or limitations provision for such claims, there was consensus that many CBI claims would be dropped if there were an ongoing cost to asserting the daim. Availability of Data Outside OPPT Over the life of TSCA there have been repeated criticisms of the fact that much of the dau collected under the Act are unavailable outside of OPPT. The TSCA regulatory process has been denounced as being dosed to effective outside scrutiny. Thus neither the public at large, nor relevant interest groups, have confidence in the TSCA regulatory proceu. One indicator of this level of dissatisfaction with TSCA was the public protest that accompanied EPA's attempt to commemorate the tenth anniversary of TSCA*s passage. Another criticism of TSCA CBI is that it hampers the dissemination of important information that has been submitted to EPA under TSCA to regulatory authorities outside of EPA. The statute dearly provides for the provision of TSCA data to other federal officials for the purpose of protecting health and the environment or law enforcement (Section 14(a)(1)). However, the operating prindpie appears to be that such officials will get such dau only if they request it; they are not notified by EPA that information relevant to their duties has been submitted under TSCA Moreover, OPPT has been insisting that such officials be explidtly issued CBI clearance. This criticism applies not only to other federal agencies, but also to other program offices within EPA OdmCffSm Within BFA Few of the EPA staff outside of OPPT have any familiarity with dam available under TSCA Moreover, because there are significant difficulties associated with obtaining CBI clearance and handling CBI data, even those EPA staff outside of OPPT who are aware of the dau attempt to make use of them. This indodcs regional staff, enforcement officials, research scientists, and toxics regulators in the other program offiom. Odm Ftdtrgl Afmda Requests for TSCA CBI by federal officials outside of EPA appear to be limited. This appears to represeat two key boon. The first is lack of knowledge that OPPT is in poasession of the information. This was upon principally by OPPT tuff, who noted that there were no mechanisms in place to dau passing on a routine basis. Interagency coordination groups, such as the one for 28 CMA. 052246 OSHA NlOSHu, and EPA (ONE) address TSCA policy issues, but do not serve as clearinghouses for distribution of submissions among the agencies. The second factor limiting access by other federal officials to TSCA CBI is the requirement that the officials receiving the information continue to give it the same level of protection afforded by OPPT. As one OSHA official noted, some information would be entirely useless to bis program if he were not in a position to disseminate iL This official reported several attempts to obtain TSCA CBI, all of which were unsuccessful, because some of the information would be incorporated into a public document. In fact, this official would have been able to use generic or categorical reports, rather than the specific data that EPA had collected as CBI, but was unable to obtain such information. This official was particularly struck by the fact that OPPT staff appeared to be far more concerned with protecting CBI than with disseminating information that the statute enabled it to share. An official in another pan of OSHA noted similar problems in obtaining TSCA CBL In the course of a major rulemaking effon (promulgation of Permissible Exposure Levels), this official sought exposure-related information possessed by OPPT. Although several OSHA staff members obtained clearances for access to TSCA CBL OSHA logistics precluded establishing facilities that met the security requirements for TSCA CBI within their offices. Accordingly, OSHA staff were only able to review TSCA CBI within the confines of the Confidential Business Information Center at EPA More importantly, in order to support its rulemaking efforts, OSHA deemed it necessary to publicly disclose exposure-related information, which would dearly have contravened the CBI provisions of TSCA In the end, OSHA was forced to conduct an independent survey of a sample of 6,000 firms, in order to obtain dam that were already in EPA's possession. The survey obtained a response rate of between 60 and 65 percent, leading the OSHA officials to condude that a substantial fraction of the TSCA CBI they had sought was not, in feet, trade secret information being protected from disclosure. This finding is consistent with the comparisons noted above, in which data that have been claimed CBI under TSCA have been made public in other contexts, and the fsa that EPA's CBI challenge efforts have had such a high success rate. A NIOSH official reported rxperiencva similar to those of OSHA Like OSHA NIOSH has been able to obtain TSCA CBI access for ia staff, but the differing security procedures for trade secrets under its regulations have precluded NIOSH from taking possession of TSCA CBL NIOSH officials indicated that they obtained duplicative reporting from industry, using NIOSH trade secret provisions, of information that bad been submitted to EPA as CBL In another case, serious conflicts with TSCA CBI provisions were avoided because NIOSH decided not to publish guidance documents. NIOSH would have been unable to publidy divulge the rationale for the guidance, because it was based on TSCA CBI. The NIOSH official also noted a successful collaborative effort with EPA OSHA and a chemical manufacturer on a ctemial that had been the subject of an 8(e) notice to EPA Joint meetings of all parties enabled the various agendas, with the cooperation of the manufacturer, to achieve a mutually satisfeaoiy outcome. However, the NIOSH official noted that if the manufacturer had not been cooperative, NIOSH would have had serious difficulties in discharging its responsibilities. No mechanism is in place to teal with such situations; a draft Memorandum of Understanding addressing such cases was apparently dropped when the specific situation was resolved. The National Institute of Occupational Safety and Health 29 CMA 052247 Scale Gownmenis State environmental programs are at least as diverse as those of EPA As a result, they have diverse needs for information on potentially toxic chemicals. With the exception of data on chemicals that are submitted to EPA prior to the introduction of the chemical into commerce, there is no reason to believe that any of the data collected under TSCA would be in any way less relevant to state environmental officials than to EPA staff. The statutory language of TSCA provides an explicit, and very limited, specification of the persons to whom TSCA CBI may be disclosed; state officials are clearly not among those covered. Recognizing these constraints, OPPT has established a Chemical Desk to attempt to meet the needs of state (and regional) officials seeking information on chemicals. State officials provided a wide range of opinions regarding the extent to which their inability to obtain TSCA CBI impeded performance of their duties. Most indiated that they had not attempted to obtain TSCA CBI; some indiated tbit this reflected the fact that they did not need the data, while others indiated that they did not expea to receive the data they needed. Those state officials who indiated that they were satisfied with their ability to obtain information that OPPT bolds as TSCA CBI were primarily concerned with obtaining toxic hazard data in order to respond to accidental releases or spills of chemiats. They generally reported receiving the information as voluntary submissions from companies to the responsible state health or emergency response officials. Others noted that state laws provided n mechanism to obtain dan comparable to that submitted to EPA under TSCA. It was noted a a source of potential concern, however, that state enforcement personnel dating with hazardous waste or water discharges, for ample, would nor be able to get this son of data. Officials were quite concerned that EPA might be setting environmental discharge conditions for chemicals at various facilities, but oot informing state officials responsible for monitoring discharges to the environment. One state official aproned extreme frustration over his attempts to obtain toxicity information and related data from health and safety studies from OPPT. He indiated that OPPT staff were completely uncooperative with his requests for Information, dting CBI requirements, despite the faa that his state's trade secret provisions were as protective of confidentiality as those for CBI under TSCA In the past, his state has presented date-sharing plans to Congressional oversight committees, although this effort was abandoned when TSCA reauthoriation did not proceed. Few attempts have apparently been made by public interest organizations to obtain data submitted to EPA under TSCA Records of FOIA requests maintained by OPPT indicate that the overwhelming majority of such requests have come from chemical companies and law firms that frequently represent such companies Relatively few requests have come from public interest organizations such as environmental groups, or from other concerned penfes sedt s labor unions. OPPT has presumed, and there seems little reason to doubt, that the FOLA requests from chemial companies and their representativa probebty reprsent an attempt to obtain information that would provide the requestor with a competitive advantage. Representatives of several nationally prominent environmental groups related their experience with TSCA end TSCA CBL Most of these environmental groups indicated that they bad never sought information submitted under TSCA The comment was frequently made that TSCA played little role in any of their activities, particularly in comparison to the Clean Air Act (CAA), Clean Water Act (CWA), 30 CMA 052248 Safe Drinking Water Act (SDWA), Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA or Superfund), the Superfund Amendments and Reauthortzation Act (SARA), the Resource Conservation and Recovery Act (RCRA), and the Federal Insecticide, Fungicide, and Rodenucide Act (FIFRA). Interestingly, nearly every environmental group referred us to a single group, and a single individual within that group, as the person to discuss TSCA One'other group did have fairly extensive experience with the PMN program, but only with respect to biotechnology submissions. Another interviewee noted that it had, on one occasion, requested dau from a study of dioxins in 104 plants, and that OPPT staff had been instrumental in getting CBI claims attached to the study withdrawn. The environmental group involved in reviewing biotechnology has submitted a significant number of FOLA requests to EPA regarding PMNs. The interviewee noted that EPA staff had been very cooperative, but that the nature of the FOLA process, coupled with the fact that EPA does not request substantiation of CBI claims on PMNs until a FOLA request is received, meant that up to three years could pass before information needed to evaluate the PMN was received. Meanwhile, EPA's review process had been completed, and in many cases the environmental release of genetically engineered organisms had occurred. Thus, the process precludes any effective outside oversight of EPA's decision making process. The interviewee noted that in many oses, the PMN submitters had voluntarily supplied desired data to the environmental group, because it was in their interest to do so, in order to avoid adverse publicity. It was noted that there was, at present, no effective alternative to reliance on the cooperation of PMN submitters. The group (and individual) with the most TSCA experience, to whom all the other groups directed us, indicated that it had essentially dismissed TSCA as a meaningful environmental statute, unless significant were made in re-authorizing the Act. This group had had little involvement with TSCA since 1988. For this group, CBI was only one concern among many regarding the effectiveness of TSCA. Others indude the fact that TSCA does not require even minimal safety testing for new chemicals entering commerce, leading EPA to rely on highly speculative structure-activity predictions, and. in particular, the susceptibility of TSCA's `unreasonable risk* standard which is subject to a variety of distortions from 'cost-benefit* analyses (EPA has recently encountered this problem itself, with respect to the remand of its asbestos rulemaking). Among the specific CBI concerns noted by this interviewee was the fact that the group could not provide meaningful public comment on EPA's proposed asbestos phaseout rule (see below). It was also noted that EPA's decision to seek substantiation of CBI dato only after a FOIA request was received had lengthened the FOIA process to the point of ineffectiveness. The interviewee also noted that EPA had, in promulpting CBI regulations, given an extremely broad definition of acceptable CBI claims under Section 14(b). Labor Organnarioms Discussions with health and safety officials in organized labor indicated that, as in the case of environmental groups, little reliance had been placed on TSCA to supply the information needed to protea their members from risks posed by chemicals. Unlike the environmentalists, however, labor representatives appeared to be more specifically concerned with information affected by TSCA CBL In particular, each of the labor ofllriali focused on the 8(e) program as particularly bearing on the concerns of their members. Some also indicated a concern with PMN chemicals, including RAD chemicals, to which their members might be exposed. g*rh of the labor representatives commented that the publicly disseminated information from 8(e) submissions did not contain sufficient information to be useful to them. In part, this did not reflect CBI 31 CMA 052249 concerns, but rather the fact that EPA was not routinely distributing all of the non-CBI information in 8(e) submissions to them, as the Agency apparently had in earlier years. Of greatest concern, however, was the lack of specific data covered by CBI claims, particularly the identification of specific chemical identities, uses, or plant sites. This was judged key data to enable labor organizations to identify potential risks to their members. The labor organization officials, like the state government officials, did indicate that if they received information to alert them to a potential problem, they had means to obtain the data they required independent of TSCA. These included specific provisions of collective bargaining agreements, threats of action before the National Labor Relations Board, and threats of advene publicity. Only one case was identified in which an attempt was made to obtain CBI from EPA, In that case, the organization had learned that a particular chemical had advene health effects not reported on its Material Safety Data Sheet. The union wanted to determine if the chemical had been included in the TSCA Inventory, but the data were denied, because the union could not establish a bona fide intent to introduce the chemical into commerce. EPA Rukmaituig (Asbetos) As noted in the popular press, EPA's regulations on asbestos have recently been remanded to the Agency, reflecting a judicial finding that the Agency's approach to regulation did not adequately consider less burdensome alternatives. Less widely known is the fra that asbestos was the first chemical, other than those specifically mentioned in statutory language, to be considered for regulatory action under TSCA. Ten yean ago, EPA required industry to report on uses of asbestos; large volumes of data have been entered into a database. Such a large friction of the data were as CBI, however, that EPA has maintained the entire database as confidential. In the nearly fifteen years that this regulatory effort has been under way, public participation has been minimal, reflecting the fact that EPA has been unable to publicly release the analytical documents that support its regulatory decisions, particularly with regard to asbestos economics and potential substitute materials. This situation dearly illustrates the Infectious" nature of CBI, in that even government-conducted analyses that rdy on CBI materials themselves become CBL It further demonstrates the potential for CBI claims to have fundamental impacts on the regulatory process, precluding effective public overnight EPA Efforts at Data Distribution OPPT has teeently initiated the *Ooing Public* program, in an attempt to make its regulatory activities more acetusible to, and better undemood by, the public. In many ways, this program offers the promise to mitigne, if not eliminate, some of the criticisms that have been made of TSCA over the past deader OPPT staff charged with --public presentations, bornwr, have noted that the Agency's own efforts to be open with tepid to is regulatory activities are being frustrated by CBI claims. A particular case in point that wm noted concerned the attempt to place a meaningful RM1M summary in the public docket, for a chemical with very high aquatic umidty, when the identity had been claimed as CBL The generic name provided for the compound was so generic as to be useless. Several OPPT staff M Under the OPPT "going public" program, this represents an initial summary public report on actions taken by the EPA to control a chemical risk. 32 CMA 052250 expressed the view that being forced to present such incomplete information to the public was damaging to their scientific credibility. Limits on Information Dissemination Under TSCA The interviews conducted for this study clearly indicate that CBI concerns have limited the effectiveness of TSCA as a means of disseminating information on the risks posed by chemicals in commerce. The interviews do not indicate a crisis in the availability of TSCA CBI outside of EPA, primarily because the organizations contacted had independent means of obtaining the data that they sought. The ability of these organizations to obtain, by other means, information that is held as CBI under TSCA suggests that EPA is protecting this information unnecessarily. In some of the cases discussed above, the information was made publicly available, indicating that it was not, in fact, CBI. In other cases, the more stringent security provisions provided for TSCA CBI, relative to the trade secret provisions of the Occupational Safety and Health Act, various state laws, or even voluntary confidentiality agreements, appear to provide more protection than b deemed necessary by the submitters of the data. Moreover, these distinctions between the security provisions of TSCA CBI and those of other iegai authorities have lead to an increased burden on industry, in the form of duplicative data submissions. However, while state and federal agencies and organized labor do appear to have access to considerable amounts of data classified as CBI under TSCA, they still indicated concerns regarding the reliability of these alternative means of obtaining CBL They also noted the possibility that they simply were not becoming aware of data submitted under TSCA that would be of critical concern to them if they knew of its existence. Finally, it should be noted that the general public does not have these alternative means of obtaining access to information that b claimed as CBI under TSCA Thb b of concern not only as it relates to the intent of the fiamen of TSCA, but abo as it may have an advene impact on EPA's credibility in regulating risks under its TSCA authority.* 1 Another approach to determining whether CBI claims under TSCA are interfering with the dissemination of information that b needed to protea human health and the environment b to compare data held by EPA as CBI under TSCA with key data needs identified by EPA and other authorities. Thb study identified two sets of cfeemfcah with such critical data needs; reports were requested from EPA both on relevant dam submitted under TSCA and on the extent to which such data a affected by CBI claims. One of there sets of chemicab comes from the SIDS (Screening Information Data Set) list of chemicab compiled by the Organization for Economic Cooperation and Development (OECD). The EPA represents the United States on the relevant OECD Working Croup. These 147 chemicals (53 in Phase I and 94 in Phare 0) were selected by OECD because: 1. Each b produced in an OECD member country in quantities exceeding 1000 metric tonnes per year, and Z There b little or no available safety data for each chemical The goal of OECD b to collect and/or generate dau on risks to human health and the environment posed by each of these chemicab, so as to assess their risks by the end of 1993. Of thb ibt of 147 33 CUA 52251 chemicals, the United States (and the EPA) has primary responsibility for obtaining data on 20 chemicals (9 Phase I and 11 Phase II); the specific chemicals are listed in Appendix F. A second list of chemicals for which health and safety information is critical is represented by known human carcinogens. The Fifth Annual Report on Carcinogens (NTP 89-239), produced by the National Toxicology Program in 1989 (the most recent such report available at the time of the study), lists 11 such chemicals or chemical classes (also listed in Appendix F).u The fact that these chemicals are known to cause cancer in humans, while sufficient to identify them as being of great concern, does not indicate that they are adequately characterized for health risks. A great deal of additional information is needed to reliably predict risks from specific exposures. Both lists of chemicals were submitted to OPFT, requesting data on the total number of 8(e) and 8(d) submissions regarding the chemicals, as well as on CBI claims affecting these submissions. This information request only addresses a small subset of the data collected by OPFT; consequently, it is possible that EPA has additional information on these chemicals beyond that which was requested. While this information request could tail to locate a significant fraction of the information on these chemicals in EPA's possession (both CBI and non-CBl), any information that was identified by this search request would be critical to assessing the risks posed by these chemicals. Moreover, this search focuses on submissions for which CBI claims would be covered by the stria provisions of Section 14(b). EPA's search retrieved two Section 8(e) submissions, one each for a carcinogen (benzene) and a SIDS chemical (octametbyi cydotetrasitaxane). Neither of these bad any associated CBI claims. More strikingly, the search produced 60 Section 8(d) submissions concerning five of these chemicals, two carcinogens (asbestos and benzidine) and three SIDS chemists (octametbyi cydoteuasiloxane, methyl ethyl ketone, and methyl isobutyl ketone). For asbestos, there have been five 8(d) submissions. For three of these, ail key data fields were flagged as C8L For benzidine, there were three 8(d) submissions, off of which had off key data fields flagged as CBL For octametbyi cydotetrasflcaanc. there were 30 8(d) submissions, three of which had CBI claims, only one of which CBI for all fields. For methyl ethyl ketone, there were 19 submissions, two of which t CBL None of the three submissions on methyl isobutyl ketone contained CBI claims. It is notable that for a list of only 31 chemicals with high priority data needs. EPA was already in possession of health and safety data submitted under Section 8(d) on five. If this success rate applied to all 147 SIDS chwnlcab. one would predict that EPA had health and safety dam on more than 20 chemisls Moreover, the Agency received several tubmhrtcmi on most of tboe chemicals, and fully 30 submimtoas on one. Although the majority of the Secttoo 8(d) information held by EPA on these chemicals is not covered by CBI cfeimi, a significant fraction (nearly a fifth of the submissions) is. This indicates that CBI claims on health tad safety studies, many of which appear to apply to material excluded from CBI protection aadcr Section 14(b) of TSCA, are preventing EPA from disseminating data for which the international community has identified a pressing need. Hexavalent chromium is one identified human carcinogen; this represents chromium in a particular valence state, rather then n specific chemical compound. The report lists six hexavalent chromium compounds as being of particular importance. CMA 052252 EXCESSIVE CBI FRUSTRATES THE INTENT OF TSCA The legislative history of TSCA presented earlier in this report, and the statutory language of Section 14(b), make jt,quite clear that Congress intended to limit CBI claims with respect to information bearing on health and safety concerns. Until very recently, EPA practices provided CBI protection as a matter of course; rather than routinely reviewing claims to ensure that they could be substantiated. Indeed, entire classes of data that appear to be denied protection under statutory language have been treated as CBI. With the exception of the recently initiated process for reviewing 8(d) and 8(e) claims, the only meaningful check on CBI claims is the goodwill of submitters. Vast amounts of data covered by CBI claims have been collected by EPA over the past decade. As indicated both by EPA's recently initiated challenge effort and by comparison to reporting under other statutes, many of these CBI claims appear to be invalid. This huge quantity of CBI data has imposed significant transaction costs upon EPA. Attempts to find persons or organizations outside ol OPFT that are making any significant use of TSCA dau have proven unsuccessful Most individuals, inside and outside of government, who indicated that they had attempted to obtain TSCA dau from OPPT noted that they had been frustrated in their efforts. It is reasonable to conclude that the (realistic) perception that it is difficult to obuin dau that have been submitted to EPA under TSCA to a significant (actor in the failure of TSCA to serve as a means of disseminating information on the risks posed by toxic chemicals. Some of the dau held as CBI by EPA are needed to meet pressing demands for health and safety information on chemicals with high exposure potential The lack of access to TSCA CBI outside of OPPT has potentially detrimenul effects on public health and safety in several ways. First, there to no way for the outside scientific community to review the risk assessment decisions made within OPPT. While there to no reason to doubt the competence of OPPT scientists, limited dan access remits 1a limited review. As an eample, the structure-activity prediction methods used by OPFT sdentists depend to a significant extent upon CBI data; they therefore can not be fully evaluated by outside scientists. Neither an an outside organization elect to test OPPT hazard and risk predictions, because the information needed to select appropriate chemicals and toxicity taring methods is covered by CBI claims. Other organizations, inside and outside of government, that could play a significant role in reducing exposures to and risks from toxic chcmteab, do not receive relevant information from OPFT. Thus, OSHA to not provided with information in a form it could use for promulgating worker protection standards, and labor unions are unable to warn their members or to raise toxicity concerns in the context of collective bargaining. Consumer and environmental groups are not able to address specific toxic chemteals to which may threaten human health or the environment. Lastly, current procedures for implementing TSCA CBI have not provided, to the individual arizen, in Senator Hardee's words: "the right to know what to in store s fsr ss the toxicity of chemicals to concerned.* 35 CMA 052253 STRATEGIES FOR REDUCING TIIE IMPACTS OF INAPPROPRIATE CBI CLAIMS The language of the Toxic Substances Control Act allows broad classes of information to be claimed as CBI, and places the burden on EPA to challenge invalid claims, even those that appear to directly contradict statutory limitations. In order to issue and sustain such challenges, EPA must go through a series of time consuming and labor intensive steps. This inherent bias of TSCA, favoring the protection of invalid claims over the risk of disclosing truly confidential information can only be fully addressed by Congress. While EPA has some administrative discretion under TSCA, any attempt to use it to reduce the number of unnecessary CBI claims on submitted information must confront the bias of the current statute in favor of the CBI claimant. For subminions that do not qualify as health and safety studies covered by Section 14(b), any information deemed confidential by the submitter must be individually challenged, a condition that contrasts markedly with the trade secret provisions of more recent statutes. Thus, for any such claim, SPA must at least notify the submitter that it intends to deny a CBI claim, and consider attempts by the submitter to substantiate the claim, While it an be argued that EPA has, until recently, made it easier than necessary for submitters to assert CBI claims, it remains true that when EPA challenges a CBI it must match or exceed the efforts expended by the submitter in defending the claim. Under the current statutory language, the ability of industry to generate meaningless or boilerplate 'substantiation' will always exceed EPA's ability to review such materials. Congressional Options rim Deaminations . One of the most direct approaches to raoMng the imbalance produced by the current statutory requirement for EPA to consider each individual CBI daim, regardlen of merit, would be to grant EPA the authority to make dess determinations of what will and soil not be accepted as CBI and/or the nature of the substantiation that is required for different types of data. This would enable the Agency to preclude frivolous or clearly invalid claims at the time of submission. Without such authority, EPA is relegated to chipping away at the deluge of CBI claims with a series of narrow ad-hoc actions to declassify information after the feet. To the extent that Congrem has not provided explicit statutory guidance, EPA would presumably make its own dass determinations with notice and comment. As noted above in the comparison between reporting under TSCA and EPCRA, the stringent requirements for asserting trade searet claims under EPCRA have lead to a much lower claim me than that seen Cm TSCA CBI, and have not ceased submitten to be harmed by disclosure of truly confidential information. The key distinguishing features of EPCRA are: Up-front' substantiation (Lc at the time a daim is asserted) Signed by High Level Official . Significant Penalties for False Cairns A narrow definition of allowable with a requirement for disclosure of generic information on information (so the public knows what is covered by confidentiality claims). 36 CMA 52254 Authorize Sharing of TSCA CBI with'State Governments The current statutory language of TSCA clearly does not provide for the sharing of CBI with officials of state governments, but only with other federal officials. A modification of T5CA to permit such sharing would address the needs of one critical group of potential users of TSCA data for whom access is currently precluded. Providing state government officials with access to TSCA CBI would presumably enable them to act to control potential risks from chemicals subject to TSCA reporting, using their authorities under state law. This would provide the public with another line of defense against such risks. As state officials are fully as capable as EPA of protecting trade secret information, no threat to the security of legitimately confidential information would arise. In itself this modification of TSCA would not do anything to reduce excessive CBI claims, but could mitigate their impacts. The experiences reported above regarding current data sharing between EPA and other federal agencies suggest that, in order to be effective, procedures for data sharing should incorporate routine notification of both state and federal officials that EPA is in possession of potentially relevant data. Establish Additional Guidance EPA would be helped by as much Congressional guidance or specification as possible of the types of information that could, and could not, legitimately be claimed as OBI in submissions under TSCA. Congress could also, independently, provide further specifications to EPA of the conditions under which a potentially valid claim would, or would not, be acceptable. For eample. Congress could explicitly incorporate Sunset* provisions on CBI claims, or specify routine periods for re-substantiation of claims. Alternatively, the language of Section 14(b) could be amended u> make it absolutely explicit that CBI claims could not be asserted on chemical identity in such submissions. Such specific statutory language would predude possibly extended rulemaking procedures and judicial confrontations over class determinations proposed by EPA. EPA Options Whether or Not Congress Acts EPA does have alternatives available to it to limit inappropriate CBI claims, which would supplement Congressional action. These actions by EPA would also have some salutary effects even in the absence of Congressional action. Whether or not there is any change in statutory authority, EPA would be wise to dearly specify those classes of information that it believes do not meet current TSCA aiteria for confidentiality. For example, as noted above, OPPT legal analysts have determined that much of the information received by EPA is subject to the strict limitations on CBI claims enumerated by Saction 14(b) of TSCA. The Agency could cither endorse or reject this analysis. If it so derided, EPA could simply put submitters oa notice (perhaps via the Federal Register) that henceforth it would be employing the broad definition of health and safety studies specified in the law and regulations, and restricting CBI daims on those studies to the specific types of information permitted under the statutoty language of Section 14(b). This would eliminate a substantial fraction of the claims documented in preceding sections of this report. OPPT attorneys have pointed out that the decision in Teich vs. FDA is supportive of this sort of action by a regulatory agency. 37 CMA 052255 Such an approach, under Section 14(b) of the current statute, would enable EPa to release much of the information of greatest interest to other agencies (federal and state) and the public, namely riskrelated information directly associated with a specific chemical. It is possible that industry would respond with blanket assertions that chemical identity reveals processes. In this case, EPA would need knowledgeable technical staff in numbers sufficient to counter such a paper onslaught. EPA remains under obligation to notify the submitter individually in advance of CBI disclosure, if the submitter responds to a request for substantiation. EPA could take a similar stand with regard to other categories of information that it does not believe to be entitled to protection as CBL In addition, it would be wise to identify those additional classes of data which have a significant probability of not being sustainable as CBI (eg. the identity of a chemical no longer produced by the submitter or exposures to a chemical more than five years ago.) While development of such a framework may take some effort on the pan of OPPT, such a framework can be used by the Agency as pan of any discussions with industry (see below), to guide challenges by the staff, and develop other policies (eg. fees (see below]). Moreover. EPA should be prepared with such a policy viewpoint should Congress decide to make some class determinations on a statutory basis. '/nrAoMfog* Through programs such as 33/50 and the Air Toxics Voluntary Reductions Program, EPA has demonstrated the potential for effective voluntary actions on the pan of industry. Industry groups have also made public statements of commitment to meaningful disclosure, such as CMA's Responsible Care Program. This would lead one to otpect that reasonable requests by the Agency to minimize unnecessary CBI claims are likely to be given serious consideration. If such public commitments could be obtained from industry, there are strong incentives for the regulated community to abide by them. Experience to date indicates that, to be most effective, such 'jawboning' efforts would need to be conducted at a high level Like the aforementioned programs seeking voluntary actions by industry, efforts to obtain voluntary reductions in CSI claims should probably be well publicized by the Agency and cooperating industrial An open qocstion is whether incentives for industry cooperation, such as the incentive to reduce emissions provided by the public dissemination of TRI emissions data, exist for excessive CBI claims. Cm rang* mi Egrtgiom Guar As noted above, the federal government has statutory authority to seek either civil or criminal p*nal*V against persons who knowingly submit false information. EPA has never yet sought any penalties far the of invalid CSI rtauns, no matter how egregiousfy inappropriate. Selective prosecutions, well publicized, could increase the perceived coats of submitting invalid CSI claims. This approach could abo be need to "backstop* other taitiativs to induce more appropriate CBI claim behavior. As a tool to fodlhate this process, EPA could require CBI claimants to sign certification statements regarding the accuracy of information submitted in support of CBI claims. This approach does not wVluai legitimate daapeements, such as a situation in which the statements made in support of the claim are true, and yet the daim is not valid seder the statute (eg. disagreements over whether or not a given data set represents a health and safety study). Addressing these situations requires EPA to provide dearer specifications of legitimate and invalid claims. Also. adding a certification statement section io reporting forms will involve a possibly extensive review process. Eliminate Overly Burdensome Administration of CBI As noted above, OPPT is already taking steps to decrease the administrative burdens imposed on it by CBI requirements. Many of these address internal EPA costs, but would not provide for greater access to data outside of OPPT. One avenue to approach would be memoranda of understanding with other federal agencies to facilitate data sharing. EPA Options If Congress Does Net Act If Congress does not amend TSCA. there are additional actions that EPA could take to further discourage invalid CBI claims. Most of these would be superseded by the statutory changes discussed above. Report Cords One suggestion for increasing the incentives (or submitten to assert as few CBI claims' as possible is for EPA to publish a 'report card* indicating for each submitter the number of submissions, the number of CBI claims, and perhaps the number of challenges issued on these claims. The idea is that companies making few claims would be rewarded by public acknowledgement of their openness, and public pressure would incline submitters to reveal as much information as possible. This reasoning anticipates effects that parallel those that have been observed in chemical industry behavior as a consequence of the public release of TRI data. It is not dear that this represents a strong incentive. As noted above, when specific information is claimed as CBI it is often possible to obtain generic information regarding the same data elements. The quality of such generic information obtained thus far has been called into question (see Appendix B). EPA could further strengthen such generic reporting be analyzing its databases and reporting aggregated data in a font that would obscure specific CBI data elements. Such an approach does not rely on any chugs in submitter behavior, but is entirely within EPA control. However, it has been forcefully argued that generic information is inadequate for many purposes, and some have questioned the ability of data aggregation techniques to adequately protect CBI when only a limited number of submissions have been received. UHnrnf SoBmemiatkm While both statutory and regulatory language appear to place the burden of substantiating CBI claims on the submitter, the onus is on EPA to challenge claims andArr demand substantiation. Under most of the reporting provisions of TSCA, EPA has not asked companies to substantiate CBI claims upon submission. Thus, companies have been free to make broad claims, and EPA has had to employ a post-faao challenge process, as with 8(d) and 8(e) submissions. The one exception was for new chemical Premanufacture Notifications under the interim reporting requirements in effect until 1983. After the removal of this requirement, the amount of CBI submissions increased significantly. Experience with EPCRA also suggests that up-front substantiation requirements can reduce confidentiality claims. To re CMA 052257 establish such a requirement would require EPA to go through a difficult, potentially time consuming, and uncertain rulemaking process. Moreover, this policy would only be effective to the extent that EPA could muster the staff resources to review a meaningful set of substantiation documents. As OPPT staff Have noted, challenging a claim is a labor-intensive process. Submitters can be expected to provide meaningful substantiation of their CBI claims oaly to the extent that there is a realistic expectation that their substantiation materials will be reviewed. It may or may not be possible to implement a selective, yet unpredictable, review process, in a manner analogous to IRS audits. Sunstts/JUsubsantiaaort There was a widespread consensus among persons contacted in this study that many data elements for which a valid CBI ei*im had been asserted would not require CBI protection at some later date. There was far less consensus regarding the feasibility of developing a workable "sunset* provision for such claims. This approach provides the benefit of the doubt for submissions where there is a prima facie case that CBI protection is warranted (eg. on new chemicals not yet marketed), and is explicitly supponsd by Executive Order 12600 (June 23,1987), for information submitted after January 1, 198S. A key advantage of this approach, if it can be made to apply to earlier submissions, is that it would automatically eliminate EPA's CBI backlog, unlike many other alternatives. However, requirements to provide individual notice prior to revealing material claimed as CBI make it difficult to institute sunset provisions without sumtoiy change. EPA might have better success with periodic re-substantiation, which allows submitters to maintain CBI claims as needed, but drops protection for those that are no longer substantiated. EPA's Office f General has determined that whenever a business has foiled to furnish comments in response to a request for substantiation by the specified due date, the information covered by the CBI claim can be made public by OPPT without any timber notice to the submitter or approval by OGC (Class Determination 1-85). This would appear to provide the necessary basis for a comparatively automatic declassification system. As in the cue of pestidde re-registrations under FIFRA. submitters would have to make a positive effort (if only the submission of routine substantiation materials) to maintain their CBI claims. This is a relatively small cost to maintain these claims. Faa am CBI dawa Bead am Oast Dmarmimtitmt Feu tor TSGA CBI daias represent another mechanism to discourage unnecessary claims by imposing costs on the submitter. In ***** cue, the costs imposed uould be direct, rather than in terms of increased effort or risk of penalty. The particular foe imposed could be selected to reflect EPA's degree of interest in public dissemination of the data, or the strength of the statutory prejudice against a particular dam of claim. This is one of the simplest mechanisms for imposing costs for frivolous submissions, and may motivate the review of CBI daims by corporate management (much u the economic losses represented by TRI emotions seem to have lead to a de-compartmeataliation of corporate evaluations). If treated u n special "user fee," which seems entirely reasonable, this could also help to provide OPPT with the resources needed to review CBI daims and safeguard legitimate CBL EPA's success in instituting a PMN processing foe seems to offer promise that this could be implemented without excessive difficulty. Open inure involve the question of whether a fee structure could be devised that is both effective and considered reasonable by submitten. 40 CMA 052258 CONCLUSIONS A vast amount of information has been submitted to EPA under TSCA since the compilation of the original TSCA Inventory. A significant fraction of this information (SO percent or more) has been subject to CBI claims. The proportion of data submitted under TSCA that is covered by CBI claims is much greater than that for data submitted under other statutes that collect comparable information, but impose more stringent requirements for asserting confidentiality claims. While it is impossibje to establish the validity of any individual CBI claim without examining the materials provided to substantiate that claim, all available evidence supports the proposition that much of the information covered by CBI claims is not legitimately entitled to protection as TSCA CBL For those cases in which a direct comparison an be made to substantially idential information reported under TSCA and under EPCRA, the CBI claim rate under TSCA is at least 10 times higher than the rate of trade secret claims under EPCRA; more probably, the claim rate is more than a thousand times higher under TSCA. In those cases where EPA has had the resources to evaluate individual CBI claims, it has determined that a significant fraction of the submissions (up to SO percent or more of Section 8(e) filings) contained invalid CBI claims. When submitten of these claims were challenged, EPA prevailed in every ease. Legal analyses by OPPT attorneys indicate that EPA has historically accepted CBI claims on data elements that are not entitled to protection as CBI under the statutory language of Section 14(b) of TSCA Easting regulatory language, as well as the statute and the legislative history, supports this analysis. Under existing procedures, EPA has no effective control on invalid or even frivolous claims, with the single etception of the recently initiated program to review 8(d) and 8(e) submissions. Currently available staff resources do not permit any significant expansion of this program, and anticipated increases in 8(e) submissions may exceed available resources. EPA practices for safeguarding CBI have effectively prevented damage to submitten from disclosure, but EPA appears to be providing protection to a considerable body of data that is not entitled to such protection; thus resources that could be applied to the protection of legitimate trade secret information are presumably being diverted for the protection of frivolous claims. Notification provisions in the statute further complicate the process of disclosing dau that have been inappropriately claimed to be CBL Because EPA's ability to winnow valid CBI claims from frivolous claims, once the claim has been asserted, is limited, EPA may wish to concentrate its resources on devising means of discouraging the submission of invalid CBI claims. In addition to the costs imposed by invalid CBI daims on OPPT internal functioning, the dau covered by invalid CBI claims represent a valuable resource that could further the purposes of TSCA if they could be more widely dbseminated. Wider dissemination of this information would fulfill TSCA's intent of allowing the public to make informed decisions regarding cbemfoti risks, and allowing market forces to remove unnecessarily risky chemicals from commerce. Public interest groups, other federal agencies, and sate governments have all tndiaied that TSCA dau could be very useful in their efforts to protea human health and the environment, if not protected by CBI claims. TSCA dau could represent a major information source to improve the scientific foundations of toxicology and risk assessment Lastly, EPA'S own efforts to make ns decisions more comprehensible to the public would also be considerably fadliuted by the removal <>f invalid CBI daims that obscure the reasoning underlying Agency actions. 41 CMA 052259 All available administrative options to discourage the assertion of invalid CBl claims are likely to impose significant costs on OPPT, at least in the short term. Any change from current policies, even those that require no change from published regulations, seems likely to encounter inertia, if not hostility, on the pan of submitters. The cunent policy of leniency regarding CBI claims, notwithstanding fairly stria regulatory language, appears to have been in effect almost from TSCA's inception. Thus, no change in policy seems likely to succeed unless it is accompanied by a corresponding effort to review and challenge CBI claims. Once submitters become accustomed to revised procedures, it may be possible to reduce the resources allocated to challenging invalid claims. A first priority would appear to be the need to clarify the implementation of Section 14(b) of TSCA through the explicit specification of guidelines (and perhaps clarification of regulatory or statutory language) regarding information that the Agency will treat is a health and safety study subject to that section. Because much of the data of greatest potential use outside the Agency represent submissions that appear to fall under this section, strict enforcement of the limitations on CBI claims under Section 14(b) might eliminate a significant number of neptive consequences of invalid claims. A firm stand on these statutory limitations to CBI ***"* would appear to offer greater promise than more general attempts to impose costs for submitting invalid This option may or may not require formal rulemaking; an explicit statutory clarification could greatly facilitate this revision. If necessitated by continuing submissions of large numbers of excluded claims, this policy could be backed by penalty provisions (which appear to require the promulption of new rulefs)). EPA appears to have numerous options to discourage invalid or frivolous CBI claims in the future. While some of these require neither regulatory nor legislative action, all entail significant expenditure or resources. Reducing the flow of invalid CBI ei*iww will not, however, address the problem of claims submitted in the past. Data have been accumulating in EPA files for more than a decade. In order to address these data, EPA fsces a truly massive commitment of effort to review and challenge activities. It may lack the resources to make such a commitment. The declassification of these data might be more effectively pursued through explicit legislative language in a reauthoriziuon of TSCA 42 CMA 052260 FIGURES CMA 052261 PMN Submissions - Total 3000 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 1979* 1982 1983 1984 1985 1986 note for 1979-1982 and 1983, parcamagaa may ba wnpfacna FIGURE i 1987 1988 1989 1990 CMA 052262 PMN Submissions Chemical Identity Claimed as CBI 3000 S Non-CBI O CBI 1979- 1983 1982 1984 1965 1986 1987 1988 1989 1990 1982 FIGURE2 CMA 0522 63 Polymer Exemption Submissions - Overall CBI Claims Non-CBI B CBI 1977 1978 1979 1980 1981 1982 1983 1984 1985 1986 1987 1988 1989 1990 100% 80% 60% 40% 20% 0% 1977 1978 1979 1980 1981 1982 1983 1984 >985 1986 1987 1988 1989 1990 FIGURE 3 CMA 052264 Low Volume Exemption Submissions - Overall CBI Claims Non-CB! H CBI 1977 1978 1979 1980 1981 1982 1983 1984 1985 1986 1987 1988 1969 1990 FIGURE 4 CMA 052265 Polymer Exemption Submissions - Overall CBI Claims Non-CBI B CBI FIGURE 3 CMA 052266 Low Volume Exemption Submissions - Overall CBI Claims 1977 1978 1979 I960 1981 1982 1983 1984 1985 1986 1987 1988 1969 1990 FIGURE 4 CMA 052261 Bona Fide Submissions - Overall CBI Claims 1977 1978 1979 1980 1981 1982 1983 1964 198S 1986 1987 1988 1989 1990 FIGURE 5 CMA 052268 8(e) Submissions - Overall CBI Claims 100% FIGURE 6 CMA 052269 8(e) Submissions - Chemical Identity Claimed CBI Non-CBI H CBI 100% FIGURE 7 CMA 052270 FYI Submissions - Overall CBI Claims Non-CBI CBI 1977 1978 1979 1980 1981 1982 1983 1984 1985 1986 1987 1988 1989 1990 100% 90% 80% 70% 60% 50% 40% 30% 20% t 10% t________ _ -- 0% 1977 1978 1979 1980 1981 1982 1983 1904* r85 198C 1987 1988 1989 1990 FIGURE 8 CMA 052271 Section 8(d) Submissions - Overall CBI Claims D Non-CBI CBI 1977 1978 1979 1980 1981 1982 1983 1984 1985 1986 1987 1988 1989 1990 1977 1978 1979 1980 1981 1982 1983 08* 085 1966 1987 1988 1989 1990 FIGURE 9 CMA 052272 Section 8(d) Submissions - Chemical Identity Claimed CBI 2500 2000 1S00 1000 c E 1977 1978 1979 1980 1981 1982 1983 1984 1985 1986 1987 1988 1989 1990 FIGURE 10 CMA 052273 Section 4(c) Submissions - Overall CBI Claims Non-C8J B CBI 1977 1978 1979 I960 1981 1982 1983 1964 1985 1986 1967 1988 1989 1990 FIGURE 11 52274 Section 6 Submissions - Overall CBI Claims 1977 1978 1979 1980 1981 1982 1983 1984 1985 1986 1987 1988 1989 1990 FIGURE 12 0522T& TABLES CMA 052276 57 Table 1 ! } CAS NO.: i 67-72-1 71-5S-6 75-09-2 75-21-a 75-56*9 77-47-4 77-78-1 78-87-5 79-00-5 80-62*6 84-66-2 84-74-2 92-52-4 95-50-1 95-80-7 96-09*3 98-82-8 98-87-3 98-88-4 10041-4 100-42-5 10044-7 101-77-9 10646-7 106-86-7 106-89-8 108-88-3 108-90-7 117-81-7 117-84-0 12082-1 123-31-9 126-998 131-11-3 615-054 744036-0 7664-393 CHEMICAL NAME ; Hexachioroetnane 1,1.1 -Tricfiioroethane Dichloromethane Ethylene oxide Propylene oxide Hexachiorocyclopentadiene Dimethyl sulfate 1,2-Dichloropropane 1,1,2-Trichloroethane Methyl methacrylate Diethyl phthaiate Dibutyl phthaiate Biphenyl 1.2-Dichlorobenzene 2.4-Oianunotoitjene Styrene oxide Cumene Benzai chloride Benzoyl chloride Ethylbenzene Styrene Benzyl chloride 4.4`-Methyendianiiine 1.4-Dichlorobenzene 1,2-Butyiene oxide Epichkxohydrin Toluene Chlorobenzene Dt-<2-thythexyl) phthaiate n-Dioctyl phthaiate 1,2,4-Trichiorobenzene Hydroquinone Chioroprene Dimethyl phthaiate 2.4-Diaminoanisole Antimony Hydrogen fluoride TOTAL TRI Forms Producers j Total / Impenort | 22 8 3.633 17 1.567 20 200 16 123 7 53 32 4 12 3 29 8 215 8 31 4 122 8 174 17 45 4 21 61 115 13 32 21 3 534 54 1,138 45 50 3 30 8 23 6 2 79m 3.704 6 106 66 9 270 12 64 3 56 9 61 6 f> 6 6 1 i7 27 i 13.164| 463 iPAIR Forms Loss** Percentage Total Clalmod CBI 53 97 10 6 19 17 C8I 60.00% 77.78% 60.00% 89.47% 6 6 100.00% 2 0 0.00% 2 2 100.00% 3 3 100.00% 3 0 0.00% 5 5 100.00% 2 2 100.00% 7 5 71.43% 7 4 57.14% 4 4 100.00% 4 3 75.00% 1 1 100.00%. 15 1 3 29 15 `3 9 5 33.33% 1 100.00% 2 66.67% 11 37.93% 7 46.67% 3 100.00% 6 66.67% 6 5 83.33% 2 0 0.00% 3 ll 33.33% 67 21 31.34% Si 5 100.00% 9 6 66.67% 3 2 66.67% 3 3 100.00% 8 1 12.50% 5 3 60.00% 4 3 75.00% 1 o 0.00% 7 3 42.86% 15 3 20.00% 302 159 52.65% CMA 052277 APPENDIX A THE PMN REPORTING FORM 59 CMA 052278 o "N, PREMANUFACTURE NOTICE Data I OX f* JCTO-00',3 , * u Ltvlv " AGENCY USE ONLY FOR NEW CHEMICAL SUBSTANCES DOCUMENT CONTROL OFFICER OFFICE OF TOXIC SUBSTANCES. TS-7V0 OS.EJJL 401 M STREET, SW WASHINGTON. D.C 20440 Enter the toUi number of pages in the Premanufarture Notice Owi GENERAL INSTRUCTIONS E7A um nua'Bar TS- Yea mm pnM U talarmarton raqoaaaad ta (hi* fen eOi MU that E t* lo or ptaooaiaMy ikoowMi by you. Mafca mmiUU nitauMi if yma do mm kni Mail Ua. leian yarn aoeiptoaB *ta farm. ymm ahoold rm4 0m ImwcSmi Maeaal lor HetflaiiM* (Inanrttona Manual! If a oaar Im haa ha fomttad for ifcta uMa 140OX 70D.4S1, Mieo to tor TS kunal naoke you kwt (winat Roaoabee, pow oaar Ira ID oootbar Mart al <Aa TSoaar In idatinAcano* mroMla| ( mniranci. Pan I - CIRDaL INFORMATION rHaFMW<O.O.Ia|U%dlkiHai too aar T0TDATA AND OMR DATA laloakaaOyMi 1 laiaanil aiMIfaNdilaikMkaaku lanwiiaY i*T|wkOa*4iaiMi mmmmtm it * lotDot ' t4l< Pan B - XUMAN OOOCUIX AND tNVIXONMINTALXCUASt Yaa aar aaad addMtooal < al pan ILi ar< a > to tte OOUM. Too toooldtopndoa AadtWtoaa MaatoepoaMl Pain-LOT OP ATTAOtMENT* Yaa 1M pa* da oto haao aoogk f. Itoda^woOi la pad QL Iko I iatkaaMN OPTIONAL INFORMATION Yaa Mr ladaAa to to* Mba lagoda It Oop^ollalttto idfnaDko Tbalaa emMiioal piaoaolPki JoatoepMaa 1 lataHO CPX Pad to tafttaai. aat tmmmtrim al Iju, totoaapoo IlMiaaa lallaaiu 4m. Yaaakaali aoMaOttow NpmmottoaPwNMalaaaia lAottoatoMmMaaaMaoalaoetoaPkpwaM I m toa Ian paga of tola too tonaapa at ______ ONI - - T" Q Tto Q Na rd Q T- Q N. dOankana Baba abtopoMBatoki |Aa,|iH CoNPTDOmAUTY OAD4S Yaa mmy itoa my UPaa SOaaM >ka ppaaCPAmtMymmm. I----- 1 Ma* 00 U aar taa CMA 052279 f^bUe nrparong burOwi lor 0\a otfoao" <* miormrooo oitmi*o to crag* no hour* per rpww mauijig mn* ior ,,,,,_n{ j'.-wtior% wonting *jnngdU *, pOwUg nd Bi*muW'g _lh*d*u n*wi< .no woiplreng and M-orwing iheeoUrenon ol inlorm.t,on r.ne nwm Wfwding tho towdan Wi or oy oOor P*n u oU*Ooo at tnicrm.oor. uwiuOihg ruggooont tor Muong (ha buroro. *> Ovid. Inhmaaon PoUey tadl PM-Z23. US Enrthoruhrm^i W0,ra0r hgmey. 401 M. S<. S.W.. W.hmgiorv D C 20*60. *n4 10 <h CXIS 0( Mgjuy^mqn mt) 6ud<T*. ftjducoor Aft (luA>00l2) ^djhi/tyton, P C 2050. CERTIFICATION ! I certify ifat re the bun of my knowledge end belief. 1. The company turned in Put I, tenon A, subsection 1* of this node* form intends re manufacture or import fora commercial purpose, other titan in small quannne solely for research and development, the subsunee identified in Pan 1. Section B. 2. All information provided in this nocks is complete and truthful as of the date of submission. 3. 1 am submitting with this norios ail test data in my porswiinn or control and a desoiption of all other data known to or reasonably aecetainable by me as required by $72030 of the Premanufaaure Nonfkaoon Rule. Additional Certification Statenant*: If you are submitting a PMN. (including a polymer oempboti nooot in acarcdanot with 40 CFR 733J50X intermediate PMN. Consolidated PMN. or SNUN. check the following uss f cwnfianon statement that applies: O The Company named tn Pan t Seeded A has remitted the fee specified in 40 CFR 700.45 (bl, or The Gompenjr named tat Pent Seaton A tea small businre* concern under40 CFR70033 and has remitted a fee ofSl00lncnfdanqiwtih40CFR70&4S(b}. in accordance with 40 CFR 723.2S0, dreek the following: the definition of polymer, t* not specificallymatfcsded from the crempnon. If you are submitting a turn in accontanct with 40CFR72330, cbedc the following 0 The manufacture submitting thh i i to manufacture or import the new chemiol substance for of40cnt7S3a n The manufscnmsr is taadHer with the senna of this section and wOmmptywith thoretUEma;and 0 The new rbw.w-oi sobeaMn far which the nonce is submitted meao all applicable exunpion conditions. >* Ths ameaeyefdiesnnanjaamalBbiAtoattireihauMreiV-nreurbtBtpeliaimefhemi^nannmsri^imemeswoi *"***mattoll USClOOL Signature and title ef Autherized OMdal (Origin1 Signature Rrquutdi Date Cenxdrnu* Signature ef agent (if applicable) r*r: Date CMA 052280 Part I - GENERAL INFORMATION ^ Section A - SfBVUT I'EH IDENTIFICATION t ?f--r SuPm'iong ^odoe m 'J S ) Man OQ ov, Confidetoai' bo* mu e itt mtnnroon reu claim U ewihdenoal. Nam* at aueiqmwdntro^.i i Hu* __________________ 'jmpnny a04roa (nimw ana iam> City. Sait. ZIP Coat dfPnii 1 b. Agent (ti appitobl*) Naan at auinoruad ortoal Company Mailing addma (nuaibw and nrt) Cry. Sat*. ZIP Cdde loint Submimr (J apptjable) N*ai el mdietuad effioal Company Mailing addma (nuaibw and e#*t) Cry, Sun. 2P Coda 2 Ttchruai Cantael <m U5.) Nadi* Company Maihng Oty.i (nunb Till* i Trlrphwit , Arm Coat Number * Tati. ^ l 1! TtUphdn* Tiite Am Cod* NwnMf Atm Cod* Ttltpbwi* , Nu<m 2 U you havt had a pra and EPA aaagpiad a PC I i U you ha*a audtmnad m aaupooe mmm/*ppUmom to> vh* chdsuml mSmm (Band ky (Ml Mttoc. mm th nusibur itaapwd ky EPA tf you he** withdrawn a pnnw.- wtanmtadd IPMN ni th* PMNhdika._________________ j II you have tubcuttad a bena ftd* taqt it tot Itw pineal ir- ' co*w*d ky thw noect. ate On bona fida ra^vaat nueiber n .r btEPA ------ 6 T*pt at Hoorn - Mark 00 ManwJrt Oaf? Banding Or1- Marl ti> Mark (XI if non* ._ ^ ( ' [ [ I < il non* i Mark (XI li nan* r1 ......... ... "~ ........ -- --r 1 IL_JI "Inpan OOnly mdtngOpno* Mark (> j~. ( ' -------- - Set)' CMA 052281 Parti -- GENERAL INFORMATION - Continued Section B - CHEMICAL IDENTITY INFORMATION Mwk 00 Oh ft-<----kn nut to any tmai you daun u ewijidanoal. Cooipt \ (CUh t or J 2 <Polym*r> a* *pprppnj Cnotplatt all mtJ It anothtf *B Mtmot <fasifc*l bMnoiy tnfarwaow far you (lor tn<r .w. I or I). m,,k (X) u* Idena/v th* namo y. and addru, e4 that pgoon in 4 cooqnuaoon Him l. CUaa t or 1 dtcottcl rot mm ru (far dafituttoraaf cUa* I and daw 2 NfaMt m* ih Inaoumm* Manual) 4.' Qjb i ufafane> - Mari 00 t or 2 a., ~ .. r,.h. -- -- > dnn*l t(pr*nMy CAS or IUPAC A MotnruUr farmula *nd CAS Kayry Niifa (if tototno CAS* * nMpMbTcMRSfay^NuiMlrv^OwAo^MiMaoflfttwnoaMarfnMoOtoAMoAofluvbirfMipaMaitwdtiM typMtlOBBtpaUan (wW*^rprvfMaML (Q FwrtdoiWttvo Wfati1 <lipo <MpfaMU 1 I Mark 00 tfa* boo J you CHA 052282 Part I - GENERAL INFORMATION - Continued ^ Section B - CHEMICAL IDENTITY INFORMATION - Continued Polymm (Far * drtnIOoe el polymer. M* tho laMtOM MaaoaU I a Lndjotc the miffibv-* Irdiatt mutfTua ' jOOand Mow 1,000 mumem. C3*C < 0|) of the lamp molecular wmfht < * ef 4* polymm you intend to maitulaourc. ci low nwkcular wmghl apeaw (not including tmtdual eionomm. reactants. or wls) below ir wmgtit P that mpMaotb Oraoikr A* eterteda 1 Minnaitnt or th< bow lor your Q Bfiiatrr Conti drnnjl aaaaiai*|Nl maim min % Mo* 10 Mart 00 thaboetf yemttarta b. You miermatlan. Mart 00 ttm Tonflrlmeir (1) - Provide die rtmucal name and GAS RagrtUyNtmfcm of m llartn Ttih ulimm If oiiijlr irh--a (IT la 3) - Inrtcam the typical mdfhi (4) - natn-1-1-1^ aala-- If jn mar a polymer deeglpdoaeo theTSCA flamlml (5> - Mart 00 tide caimim if maim In animate 0) and (4) (6) - lallauthaMurtmmiihipmHd (7) - Mart OOthla If may la < i (fib 0) I fiilntl I la the aumrtouri of the polymer. tadMpalymm. oaed at roo weight percent or leaa m be UrMd aa part o! ihr rtataayhe aaa tnchepgiymma* idearty MmkOO (4) Modi W M) Can*. m PI Mark 00 two hou if youi i% CMA 052283 Fart I - GENERAL INFORMATION - Continued ! Sccnon B -- CHEMICAL rO EN 7 iTY fNTOR/rlATION-- Continued" i tBrnrirr^ lu - fiem** ua ls**orr ia mrr b* t>. OLS * T~~ Hmm+m 'mtir B I'Uttii ai3B*a 1 U urn m b b* ksnl uifannk li Ik* far i*i**f1Bi * BBtUBihB Ib BBamlil M n*f Ni4alUla4 ni-i...iL.-.----------M|Utua[.. --| Ulk* w nrtaillwk i ia Ma*i imi bui ri|u a. Lmpunrr CAS Rtpsiry Numto (i) M*irmicn Conli. prtcmt dfnn.ll fb) l~J MiikOOthto^otUyotmd> 4. Sjmojtw- Bjr ijMnjm tar dw i 1 ml. n MaifcOQtMitaBtfyquMdiaaanAm S. Tra4 - Lt mte mm for the ana tL I"! M*ikOQtfeibtfyauadia< A. Ca i If jiiirlrtn rti--trriirtwftt) umrfirtirinil j~ir~r*]-- `'n|Fi--T------wi nanfc yourub*nc M*d tfw TS^OmbmI SukmncTtaMMMnr, INS A44Wmw A^aadU 8 tar fuidiM on 4**Sopu| rn MtfcOOtttofcMlfyMawrte--Blfcy--b-- rt. IjriiiiBiB nittiiT>jjra*rtiriiiintiT-^---------f--r-- --------- ~~l n---------n^-- ______________ )W)WWL WKda tfca CAS Di^tNikmw t xr .......- * CAS >4pgy Number (3) Car 4rm CMA 052284 .Part I - GENERAL [INFORMATION-Continued Section C - PRODUCTION, IMPORT. AND USE ONTFORMATTON ! -- *"**** ** 'Con&Atraii botjHti t0 wy lltm you djjg' u confiacnB4L l Production ohun the ptoduceoa 1 f any i StftjtvTin'uiir-"" dunny d fir* >2 emwiha o< praducoan. AJ*o rTn I? cidnth period dtirtnf ftff r^ * praducoon. Miaavigi ic-jtr 12-maiA-Mx)ucnon fk|Y*rf Miiumrnii? month oroduenem fkr/yfj Confi dential Op*Mr% ui 1 Uh Information - You mw make wptna* awihdoinaiitf Claim* hr tha teoywn of tlto attforp of km. lh peosw di produceon .oIuok devoted to ad\ category. the forouifttoa of the new tutoianct. and athff uot tfiiomaoon. Mark 00 the 'CanfttsiaaT Box nni to any urm row dust nftd*rd*L . (]) - D*nb --c*i intended category dwdlhc new chrnuai ubiwa by hnsai and appOaoon. - Mark 00 thia ntumn J wia-f in aoitmvn (1) a esnAd*iaal kwm tnforataoon (30. (3) - l/idiat* four wtlljngn-- ao have the wiennaoen pomdad m column (I) btodtng. (4)- Eacmaic the pouw ai tool prodiace-- tar the firm three ton demand wdt --a--y o< t-- (5) - Mark 00 thi* --ut if wrf in coltm*n () to cxmAdauul toaaei-- tolar--ne (3a (-E*oaiaiethep--wtof th*nwmto--atoaoniiaartineila--.--p-toa^--nidi--.antm-noc gatoaa--nufnetured for aowmil piipna M under powconeot (oodiHd Mi di oarndm (7) - Mark 00 thi* oah--n tf wy in datum <) to --tAdanaal tonto-- infer--boat (30. (I> - Mark 00 wh-- th unt a an limiwd. into--uL coo--1 wd/or --to--to. Maifc--i* than aw bosif appaoptiatt. Mark 00 to tndiat* four wiUw| (to - Mark 00 thi* ahmui tf oiox--> in eotuetn (1) a aretesmitt--tb--n--etlCT .................................................... I C--goryef iw 0) 31 MMW aen 31 je^ 3! JBL O) ) __ JBL JZL Mark (X) appropnate cetumnt*) (1) CBJ Indian o* Binding Wat gunUJ Option (to %% If you have identified a' chemical substance in < expected in consumer ] product. Ow*rk 00 (ho bo* Iff-- 1 b Cwtwie keen* TJ7t %% ' 1 % .* 1 %% i 1l1 ! %% 1 . pliki provide on a continuadon sheet a detailed do--ipoon of the um() of tht* fat addition include --mu-- of theoanasittidon of the new chemaal lubtxiKtii i chemical reaction* by which thi* substance )o*a* it* identity in the consumer f i-- dewnr a Mi*u lamptaato gsnanet-- of that Mi ark 00 too boa it fou awaidi a 1. Huard latowmiaa - Indude in eh* or th mtorouoen "tud' will bt Nup--i or pt*e-- tor the safe CMA 052285 ^v, * -all . a copy d noanirtr .* an* haaard wwmn| anf person **no iwimh tiaet* to b* n--M to thto UM. --tal tain* jji j u*' ' rvprdutf pro*cn>r or arjapiw. UeoymllltoMrtido-- to* PiTt II - human exposure and environmental release Section A - INDUSTRIAL SITES CONTROLLED BY THE SUBMITTER Complet* oni A Im yp* < luMhaut. pfw****'tm " * niMnit il iiidtivul ><M fM ami ______ (fern utivftrfeig d> * dianioi Mat DO Uvt *ConA4etQAi`bo* **** <e *r *r you cLvoi m eanfideioaL Oparins* daioipaoo t Identity - Errq ih* trigger NA0M whidi t>a ppertnoo ~-01 occur Suit iliwib* mdwaiQ City. Camry, Scat*. ZIP Cod* Idarafy mSmsmI 4mon a mwaiwiMW Am ahvoCdtaa. | ) HotOOUtteKjMitMdii *2S 1-1--------------- *--, . t AMWiindOinan>CMOloillafNimn IIwdMil kg/Wh | Han/hat* j latdM/yaaf 1. latch MaMSMtakg/day j j Houa/dap .| j t*w/*ar 1 GnMum A Pm-- tMnrtptliM Mach CO btodkaaty--ftiUdgwl--7-- pw*4--nripdoo Wndfaig. fl> Olayam dmotajar dt cy QMflm my and ifcoMh-il nwAiwa rr * iMc|TTTnThhriTi-h|hltVr1-ti,i1c3--r`-|-|**--^il TJ----f- -"*--*-- 1 1 -A w CMA 052286 f Part II - HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE - Continued u Section A - INDUSTRIAL SITES CONTROLLED BY THE SUBMITTER - Continued 1 Up--x ** eepurettaiAf<Ulltyfrlwforthdoagpoonof ^yalfaedih.... tubuMt iu6* < *ftd dtfvdM oc Mjrk 00 th *Cantetttkl* bos next to sny item you doa\ o coohocncul ()) - D*aaib* the Alvina **** ukei stay be *po*d ittModmalmUmo, f7) - Mart 00 thu aaiuom danyto cofiam mIsanMe'Ml baowu intofoaden(CTO. m - Doenbe any fjnjia*e |ie|Miuji nd npMv| mania toad to ^anou xvtoi (4) *nd (6> - IncUcite you have the Pvvtdad to oitmt O) er 0) bw^ln(. (ji - b*i*at* Uw phra-sl f~~W "if the nnr rtumiral r-t~r~~*r it the time irf iipim (7) - Mark 00 this column U may hi attain (5) U oonAdaoal btsmaaa infonnaooo <30. IB) - Esomatc tha majoonan mnbe of ocrkoi bivefvad In odi savvy. (?)-Mark 00 this attain if may to attain A) Is anfldanal ksiMuinferaianan(30. nO) and Clt) - Eaoma iha aiaxaitat duranon of the aedvtiy fee any vorfcar in hours pa day and days pe year. 02) - Mark 00 this ontumn tf mataa in alumna Offl and (tl) anmnfirianflit Tsinaninformation(Of) Wko savvy (l) 31 Pin now Eewymiu/ fajaaorvuCanooU Uadtaf ntystal IMU| 31 a of Worker* MMW fomft) Mas u 31 Miamuxn dura eon 31 Hn/day Oays/yr a> 01 _ Ml. (5)_ ( n L (10) (tt) (_J Mk 00 due hoe K you anach a 1. taykwwl laMan and (71 MakOOih* dannaowda) of idao m wv n POTW provide namfs) Maw. OU NavipMe -euroy OU- npoesa CSi CMA 052287 Part II - HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE - Continued Section B - INDUSTRIAL SITES CONTROLLED BY OTHERS Zaeiptttm aaon B tar ryptcal torson B for t<S tyy* hit doubt tf> rrpial a OpeviM Dttenpr M) - Dugas' ih m IZ) - Provuit lb* tdstery. and eauiyto. tre) IJ> - l< orwm** "*d**`***""" r~Oo cnpU; .Vpt" ** epmOMi OivqWng *" "** tan<. U < mm operation w pstannvd i mart than or, tMwifi IQ dipt twiw Citg U>* number oT ta |---------, Idannfy addiboim io on conanujnoo thnn Worwtoon m ita * * eonAdouUt. d or brack* Um ^ofic MmuMi Ml you Aum * eonltdtns* --trap* and dtmtanl axivtraon* On thtdiipao'. idtnttfy by torts and brttfiy dscnbt tach worker atony --------- 1 eight Ay kg/day kg/badii and ooy potort M aO Ittiiarndj (inducing rvacunta. Mnno. by numbs <ht pans of tarn to the atwonstaat af Os ms chtical aubbtanat. r~l MsfcOOtkMbastfyMt 2. Ws-fcarl na>>-.ii >-i WoOaalktaqrj nOi-bOMMMoa Q1 ns<tooftt( rfeCdhmpM*?* ssy^ijst1 tail tarCtttaot *T id Martin OB AO- Mir OJ m n ---- 1 I 1 -------- l1-------- 1 1 1 -- m> - tv 1 l l l l ___ 1 i MUwiBtiAM. itof ^SmT^ CM m <n Ml tin I 1 1 1 1 1 1 1 1 t 1 1 1 1 Tarttooiogy 0 C _1 CMA 052288 optional pollution prevention information ! To cUun vrvformanon m this section as confidential on;It or bracket the ipecifie information that you claim as confident. i ! In this section you may provide information not reported elsewhere in this form regarding your i efforts to reduce or minimize potential risks associated with activities surrounding manufacturing, processing, use and disposal of the PMN substance. Please include new information pertinent to pollution prevention, including source reduction, recycling activities and safer processes or products available due to the new chemical substance. Source reduction includes the reduction in the amount or toxicity of chemical wastes by technological modification, process and procedure modification, product reformulation, raw materials substitution, and/or inventory control. Recycling refers to the reclamation of useful chemical components from wastes that would otherwise be treated or released as air emissions or water discharges, or land disposal. Descriptions of pollution prevention, source reduction and recycling should emphasize potential risk reduction subsequent to compliance with existing regulatory requirements and cut be either quantitative or qualitative The EPA is interested in this information to assess overall net reductions in toxicity or environmental releases and exposures, not the shifting of risks to other environmental media or non-environmental areas (e.g., occupational or consumer exposure). In addition, information on the relative cost or performance characteristics of the PMN substance to potential alternatives may be provided. All information provided in this section will be taken into consideration during the review of this substance. __ Describe the cxpiaul mc beirfo, such as 0) an overall reduction in riah human health or the wvuonmeru; 12) a reduction in the volume manufactured; (3) a reduction in the generation of warn materials through recycling, town reduction or other means;) a reduction in potential awddty'.or human npoeure and/or environmental ideate; (5) an inseue ut product pmfetmance. a deouaae in the coei of production and/or improved operabon tftdmtqr ofthe new cheminl substance in companion to easting chemical subemnees toed in similar applications; or (fi> the cent to whidt the new chemical substance mar bo a substitute for an etistinx substance that poses a crater overall risk to human health or the environment. j : * -- j * ctvttinusnoA CMA 052289 Part III - LIST OF ATTACHMENTS confrmflv ihtfw to i3Ajcrup/cBviry toluinwnm' -nidi tt rdaiaa. U ipproprti luciber) at acft aiadifto fXi #i< 'ConfitomttaT guidan** on how id ditto form j uniiuod i or torn at > I s *" to* lartn tot * * ind otow data (toduding pfcydal/chauaJ propvao *nd o^oml tolawiaoon * tou P*t aariy idaiafy to* saichaieii Md to* Meson ol to* form to ^n**w0*dy to* P***3 at to* anaduwa. In tocatumn b*k>w. oils to* mduax pag* any ttotoiaipt nan* you ditto as ewtotdoitUI. K**d to* lnunniaii Mmul (or to an aftadltodM u wnfidntail. Ym onto todud* with to* tamtuod copy ed h nooct oil in wtudi you dirni m/oraiiaon is --(Irfirntl Atjehmni j Con<1. paftnutobcKf) dinmi n Mfc 00 tola ho* d ji into a Ooo to tot two ib* nn nouot mm and M CMA 052290 PHYSICAL ANT? CHEMICAL PROPERTIES WORKSHEET To uu EPA't rrvWw and mdud< >i in ih ot th pruye tf. lh confidoitul. Ye review and ryour tuPtn' and dierucal proper** data. plowe eotnplei* the following warkjhc*< for dan you provide * Wcittfy the proparry tnearurtd. the page of the noeca on wh** me propot y tppean. Ifce vtiuc wtddi Am piopury a maMurod (a* n wai iry). and w*cm or not me prupoty u dauned as xyjird to rubdut tho workah^i: ho-*v. EPA wrongly recotmnendt that you do to. it w^j lin,plliy datOal Woraiadon o property proractod. You thmdd ndnu thu worfcaheet a a uppinem to Thu mmviium ta not a tuOtonji* for tubout*or of tot data. Vapor ptowurc Taaipmrwo --. Dtrvnry/rolatlre dowry Soiuhiiity SoNdrt Mark 00 if povtdod Pag. numbs (b) C C Vatu* (d ConndenoaJ Mart ft) Idl Torr g/arU g/L Solubility ta wmas 4 Ta^mnn C C Matting wtpnnw C Botlinft/wMtgiaBoit fyan 4. Partda wtu rtjorrtMrtm /nv Hanry'tLawt VolidUBdaataHfl P RanmaMllty EsptodaWkty Oho - Spotdfy CHA 052291 APPENDIX b THE NEW CHEMICALS (PMN) PROGRAM When submitting a PMN, companies must provide such information as a structural diagram (if the substance can be represented by one), chemical name, CAS Registry Number (if available), and molecular formula. Other information reported includes the impurities anticipated to be present in the substance, any known synonyms or trade names, the estimated maximum amount to be manufactured or imported during the first year of production and during any 12-month period during the first three years of production, and a description of the intended categories of use by function and appliation. Additional information may be reported depending on whether or not the site is controlled by the submitter. Such information would include specific site information as well as a description of the operations involved in manufacture, processing and use, worker exposure information, physical form of the new substance to which workers may be etposed, the number of workers and the duration of activities, and information on release of the new substance to the environment (40 CFR 720.45). The submitter must also send any available test data related to the effects on health or the environment. Based on the information provided in the PMN form (see Appendix A), EPA must assess the risks to ascertain if the chemical may or will pose an unreasonable risk to human health or the environment. EPA's assessment is highly dependent on the quality of information submitted. Even though it is EPA's responsibility to determine chemical risk, EPA annot require manufacturers to perform testing of new chemicals unless it has made a determination that the chemical may or will pose an unreasonable risk. Based on the information received in the PMN, EPA has four options with regard to the substance. 1. It can do nothing and the chemical may be manufactured without restriction, subject to the manufacturer providing notice to EPA via a Notice of Commencement. 2. The Agency can issue a significant new use role (SNUR) which requires manufacturers or processors to notify EPA in the future if they intend to process or produce a chemical for uses beyond those stated in the original PMN. The Significant New Use Notice must be submitted 90 days before commencing manufacture, import, or processing of the chemical substance for the new use. 3. Under Section 5(e), EPA can issue an administrative older or obtain an injunction to regulate the manufacture, processing, distribution, or disposal of the new substance pending the development of new Information. Section 5(e) may be invoked only if EPA determines that the chemical may pose an unreasonable risk, in that information received in the PMN is insufficient to make a finding with respect to its health or environmental effects. 4. If EPA finds that a chemical win pose an unreasonable risk, it may act wader section 5(0 to limit or prohibit the chemical's manufacture, sale, me, or disposaL KMilMtbwi at the Generic Chemical Name bv EPA (40 CFR 7MJ5 ft)f31) If the chemical identity of a new chemical is claimed as confidential, the submitter must provide a generic name at the time of the data. EPA will examine the generic chcmial name proposed by the submitter claiming confidentiality. The generic name proposed by the submitter must be only as generic as necessary to protect the confidential identity of the particular chemical substance. The name should reveal the specific chemical identity to the maximum extent possible. If EPA approves of the generic name, it will be placed on the inventory. If the name is more generic than necessary to protect the confidential identity, EPA will notify the submitter within 30 days that further consultation is necessary. CMA 052292 75 PMN Exemptions Exemptions to the PMN process are made for polymers, chemicals developed solely for use in research and development, and chemicals distributed solely for test marketing purposes. Substances developed for test marketing may be exempted if there is a finding that the chemical in commerce Viii not present any unreasonable risk of injury to health or the environment--* (Section 5(h)(l)(A).(B)). When a company is reporting a new chemical, it may exempt itself from pre-manufacture notification requirements if the particular chemiral substance is not included in the public inventoiy but falls within one of the generic chemical names in the appendix entitled 'confidential identities.* The submitter may ask EPA whether the substance is on the inventoiy and EPA will provide the answer if the submitter has a bona fide intent to manufacture the substance, in older to establish a hone fide intent to manufacture (40 CFR 710.7 (g)(2)) a specific chemical substance, the person proposing to manufacture this substance must submit to EPA: 1. A signed statement that the person intends to manufacture the substance for commercial purposes; 2. A description of the research and development activities he has conducted to date and the purposes for which the substance will be manufoctnied; 3. An elemental analysis; 4. Either an X-ray diffraction patten (for inorganic substances) or a mass spectrum (for most other substances) of the particular chemical substance; 3. A sample of the substance in Its purest Com, if requested; and, 6. Any additional or alternative spectra, or other data that may be required to tmolve uncertainties with respect to the identity of the chemical substance. Once a bona fide intent has been determined by EPA. a comparison will be made between the generic substance listed on the inventory and the substance being newty reported. If the comparison of the elemental analysis and either the X-ray diffraction pattens or mass or alternative spectra is sufficiently similar to be comment with a presumption that the chcmiral substances are the same and comparison of any of the other submitted information affirms this, EPA will tell the submitter proposing to manufacture the particular chemteal substance that the particular chemical substance is included on the inventoiy and that pre-manufacture notice is not required (40 CFR 710.7 (g)(5)). If the comparison of either the X-ray diffraction pattens or the mass or alternative spectra does not prove that the chemical substances are the same, and comparison of the ocher information affirms this conclusion, then pre-manufacture notice is required (40 CFR 710.7 (g)(6)), since the substance is deemed not to be included on the inventory. A manufacturer may also apply for aa exemption for a new chemical (or category of chemicals) from all or pan of the PMN requirement!. This exemption may be granted under section 3(h)(4) if EPA determines that the use of this chemical m commerce will not preseat an *uaieasonable risk of injury to health of the environment* Section 5(hX4) exemptions require formal rulemaking. 76 CMA 052293 APPENDIX C REPORTING AND RECORD-KEEPING (SECTION 8) Section 8 of TSCA gives EPA (he ability to collect information on existing chemicals (Le. chemicals in commerce). Section 8(a) allowed EPA to promulgate rules under which chemical manufacturers are required to maintain records and report the following information (Section 8(a)(2)): the common or .trade name, the chemical identity, and the molecular structure of each chemical substance; the categories or proposed categories of use; the total volume under existing uses with projected volumes for proposed uses; a description of the byproducts resulting from commercial chemical use; all costing data concerning the environmental and health effects; ccposuie data; and, the manner of method of disposal and any change in the manner or method of disposal. Claims of confidentiality are made according to the general procedure. If the company tails to provide a second (sanitized) copy of the notice. EPA notifies the submitter by certified mail. The submitter must send the second copy within 15 days of being notified; otherwise, the confidentiality claimed is waived and the first copy may be placed in the public file (40 CFR 704.7 (c)(4)). Other Chemkul Information Rules (40 CFR 712) The chemical information rules as sated in 40 CFR 712 establish procedures for chemical. manufacturers and processots to report production, use, and opcsure-related information on listed chemical substances. Chemical mixtures, and categories of substances or mixtures which have been recommended by the Interagency Testing Committee for testing considerslion by the Agency but not designated for Agency response within 12 months are included for reporting under this rule, only to the extent that the total number of designated and recommended cfaemiab does not exceed 50 in any one year. Under the chemical information rules, any information reported on the appropriate form may be claimed as confidential, and substantiation requirements are met by checking the appropriate boxes n the form. If no claim accompanies the information at the time the form is submitted, it is placed in the public file without further notice (40 CFR 712.15(c)). Partial Updating of the Inventory Pea Base f4Q CFR 710 Sobuert B) The Master Inventory FDe is EPAh comprehensive list of chemical substances which constitutes the Chemical Substances Inventory compiled under section 8(b) of TSCA It includes chemical substances reported under the initial inventory reporting requirements as well as substtnces reported under the pre manufacture notification program for which a Notice of Commencement of Manufacture or Import has been received. The first update for the 1977 TSCA inventory occurred in 1966. The next reporting period was 1990 and subsequent reporting periods will occur at f ur year intervals thereafter (40 CFR CMA. 052294 77 710.33). Updated information must be reported for chemirals which do not fall into one of four broad classes: inorganic chemical substances; polymers; microorganisms; and, naturally occurring chemical substances. 78 CMA. 052295 APPENDIX D HAZARDOUS CHEMICALS IDENTIFIED UNDER THE ACT Once EPA finds that a chemical poses an unreasonable risk to human health or the environment, it has a variety of options under Section 6 to control the commercial use of that chemical. EPA may apply any of these options by rule *to the extent necessary to protea adequately against such risk using the least burdensome requirements/ Among these options (summarized below) are some that require the public dissemination,of risk-relevant information (emphasis added): prohibiting or limiting the commercial use of the chemical substance or mixture; prohibiting or limiting the commercial use of the chemical substance or mixture for a particular use or for a particular use in a concentration in excess of a level specified by EPA; requiring that the chemical substance be labelled with dear and adequate warnings with respect to its use or disposal; requiring that manufacturen of the substance make and retain records of the processes used to manufacture the substance and monitor and conduct tests which are necessary to assure compliance with any rale that EPA has promulgated; prohibiting or regulating any manner or method of disposal of the chemical substance; requiring manufacturers or processors of the chemical substance or masurt to provide notice of unreasonable risk of injury to anyone who may come in contact with the chemical substance, to give public notice of such risk, and to replace or repurchase the chemical substanceor mixture, whichever is chosen by the person to which this requirement is directed. && By rule, EPA requires reporting by persons who manufacture, import, or process asbestos and asbestos-containing products. Different reporting requirements are imposed depending on the person's activity. Manufacturers, importers, and processors of commercial and industrial asbestos fiber must report quantity, use, and exposure information. Importers of matures and articles containing asbestos and processors of asbestos mixtures sko report to EPA in two phases (40 CFR 763^0 (a)). They initially must report limited information about processing or importation. Some must subsequently report additional information if they are selected as respondents in s sample survey. Claims of confidentiality may be made for any information submitted. Certificstioa is nude by signing the certification statement specified on the reporting form(s). If no daim accompanies the form at the time the form is submitted, then the information may be placed in a public file without Airther notice to the submitter (40 CFR 763.74). In addition to requiring reporting by manufacturers, importers, and procenors of asbestos, EPA has identified s list of asbestos-containing products which have been prohibited from manufacture, importation, procosini and distribution in commerce. EPA may grant exemptions for products subject to this rale. In submitting an application for an exemption the submitter reports such information as (summarized): a description of the manufacturing, import, processing, andfor distribution in commerce activity for which an exemption is requested; identification of the locations at which the exempted activity would take place; length of time requested for an exemption (maximum length of exemption is four yean); oeposure levels over the life cycle of the product; and data concerning the non-asbestos substitute (40 CFR 763.173(d)). Any of the information reported in an etemption application may be 79 052296 claimed as confidential according to the general procedure. If the submitter fails to submit a second copy of the information, he has 30 days from the date of receipt of notification to submit the second copy, else the information is placed in a public file. Applicants who assert CBI claims must substantiate all claims by providing detailed written answers to the questions listed below. 1. Is this information subject to a patent or patent application in the United States or elsewhere? If so, why is confidentiality necessary? 1 For what period do you assert a data of confidentiality? If the claim is to attend until a certain event or point in time, please indicate that event or time period. Explain why such information should remain confidential until such point 3. Has the information that you are claiming ns confidential been disclosed to persons outside of your company? Will It be disclosed to such persons In the future? If so, what restrictions, if any, apply to use or further disclosure of the information? 4. Briefly describe measures taken by your company u> guard against undesired disclosure of the information you are as confidential to others. 5. Does the information as confidential appear or is It referred to in advertising or promotional materials for the product or the resulting cad product, safety dam sheets or other similar materials for the product or the resulting end produo, professional or trade publications, or any other media available to the public or to your competitors? If you answered yes, indicate where the information appeus. 6. If the Agency disclosed the information you are claiming as confidential to the public, how difficult would it be for the competitor to eater the market for your product? Consider in your answer such constraints as capital and marketing coat, specialized technical expertise, or unusual processes. 7. Has the Agency, another Federal agency, or a Federal court made say confidentiality determination regarding this information? If so, provide copies of such determinations. 8. How would your company's competitive position be harmed if the Agency disclosed this information? Why should sack ham be considered substantial? Describe the causal relationship between the dlecloaute and harm. 9. In light of section 14(b) of TSCA, if you have cUtmrri information from a health and safety study aa confidential, do you amen that disclosure of this information would disclose a process used in the manufacturing or processing of a product or information unrelated to the effects of asbestos on human health and the environment? If your answer is yes, explain. 80 CMA 052297 APPENDIX E CBI SECURITY PROCEDURES The security requirements for CBI are based on four components: Administrative Security, Facility Security, Procedural Requirements, and Audit and Inspection. These components are discussed below. Administrative Security - Access to TSCA CBI is granted only on a `need to know* basis, and is limited to EPA employees, EPA contractors and their employees, and others only as apUdtly addressed in the statute (see previous section). Even EPA grantees (such as those working in the Amerian Association of Retired Persons program alongside EPA stall) and states may not be granted access to TSCA CBL Access to CBI is allowed only for those sections of TSCA for which the employee or contractor has demonstrated need. Each EPA employee or contractor employee who requests access to TSCA CBI is subjected to an extensive background investigation, referred to as a National Agency Check and Inquiry (NAG). These investiptions are intended to reveal any information that may reflect adversely on an employee's suitability or trastworthinem to handle TSCA CBL Authorized access to CBI is reviewed annually. All employes most attend a 31 procedural review and pass a written test. All senior OPPT staff ate reviewed annually to determine conflicts of interna. This review includes tall financial disclosure with oversight by the OPPT director. All persons given accem to 31 aim sip a confidentiality agreement, which gives notice of the penalties for willful disclosure of 31. as provided by the statute. Ffftilltt Starttt All facilities handling 31 provide for limited accem. Bufldinp are guarded 24 hours per day, seven days per week. . Secured areas within EPA may be designated as *open shelT document storage fedUties. These areas are second through the uk of electronic aid entry identification badges. Employees who have been toned a card an required to use it each time they cater a card entry secured area. Unless 31 material to being used in an approved open stomp ana, it must be stored in an approved container at the end of the business day or when not in use. 31 material must be stored in a file with a bar lock and three-way adjustable lock, or GSA-apprrwed Ctass 6 security container. F*'~h must also have a SafeAOabinet Security Check Sheet attached to indiate opening and dosing as well as when checked. Procedural Requirements 81 CMA 052298 Once a document is classified as CBI, it must be logged into a document control system or the TSCA CBI inventory log. It is assigned a document control number and stamped TSCA Confidential Business Information ... Does not contain National Security Information (E.O. 12065).' A cover sheet is attached which contains the name of the Document Control Officer (DCO), the document control number, and the date of receipt of the original document The document is tracked until it is either declassified or destroyed. If a person authorized for access to CBI wishes to obtain a CBI document he must go to the Confidential Business Information Center (CBIC) and request the document from the appropriate DCO or Document Control Assistant (DCA). The DCO/DCA verifies that the requester is listed on the TSCA CBI Authorized Access List and then obtains the document from either local secure storage, another DCO, or an authorized computer facility. Each person who retrieves a document containing CBI from the DCO or Document Control Assistant (DCA) must sip the cover sheet Documents must be charged out on the Document Tracking System or logged out each time the document is removed from the custody of the DCO. The employee must either keep the document in his/her possession at all times, return it to the CBIC, or store U in a locked approved stomp container. Documents containing CBI cut not he transferred directly from one person who is cleared for CBI access to another, ezcept for a limited period. To effect a transfer between cleared employees, the person must p throup the DCO/DCA by use of a Loan Receipt for TSCA CBI, or the document must be togged back through the CBIC Any copying of documents CBI mast be performed on a machine that has been denied for this purpose, under the supervision of a spedaOjuiained Document Control Officer (DCO). With the scepttoa of working paper and draft copies, the DCO/DCA must enter all copies into the Document Tracking System or Inventory Log for document control The destruction of each document containing CBI mum be supervised by a DCO and noted in a Destruction Log and the Document Tracking System. Declassification of documents or magnetic tape a performed under stria procedures when attempting to satisfy an information request. Declassification also ocean when the submitter who requested that the Intemattoe be handled ns CBI requests that it be declassified. (In actuality, this rarely ocean.) All CBI top must be retained tor at lean five yean from the date of lam entry in secure storage. Automated data systems may only be used to process CBI with elaborate precautions to prevent disclosure of CBL > These are located in detogaated CBI-secure areas. Data lines between these secure areas are secured by means of data encryption or the use of closed conduits. Outside of areas, the operator must retain axlusive control of the PC and any peripherals, and must ensure that any CBI contained in non-removable storage media or in the computer's CMA 052299 memory are completely obliterated before relinquishing control of the PC Even printer ribbons used to print CBI themselves become CBI and must be protected as are documents or computer disks. Mainframe computers that process CBI oust operate entirely within a CBI environment, and steps must be taken to completely remove ail CBI from such a system when transferring from a CBI operating mode to a non-CBI mode. Communications lines between computers that any CBI must be encrypted. Until recently, this applied even to lines passing through son-secure areas within EPA buildings. Audit and Inspection Audit and inspection ensures that security procedures in place actually protect C8L The TSCA Security staff investipte violations and provide expertise on physiai and computer security issues. Periodic and m*TM**TMTM* inspections and audits of facilities are conducted by the TSCA Security staff. CBI documents are also audited annually. OPPT conducts periodic evaluations of TSCA CBI security procedures. TSCA CBI security requires considerable effort While the TSCA Security Office has a small staff, many of the perymn*! in the Data Branch devote n considerable portion of their time to safeguarding CBL Their responsibilities and the responsibilities of other personnel who handle TSCA CBI ire summarized in Table E-l. This table is not an indusfte list of CBI security tasks performed by personnel at EPA. but attempts to highlight the major tasks which are time intensive. Table E-2 provides a list of logs and tracking documents used in crating an audit trail far CBI material CMA 052300 S3 lealr Table E-1 AA Dir. Mr. OKI Dtr. Oen. Serv. OPTS OTS IMO omu fssd PooMon TMo Dht. Branch Otra. ChMa Security IMD EPA DCOe DCAe ooc CIS Prof. OR. Obtaining Authorization For Accaaa Procerramg Forma For Accom io C8I Approving Contractor* For Accaaa to C8I Preparing Signing Federal Boglator Hotlcaa Ensuring NACIe ara conducted tor Moral omptovooo Rsquastlng / Removing Employao Accaaa Invastlgattona and Inapocttona Initial and Annual tnapadlon Impaction ol Computer FedMies Impaction of Phyticel Security X XX X X X X .. X X X X XX XX X r-i o CM . X IQ X $5 CJ Maintaining Authorization Maintaining the Authorized Accaaa LM Annual Security Training Quantity Security Oiacuaaton Emuiaa that amployaaa ara proparty approved XX ,X X X XX PoHclae end Pioceduree lor Security Overall Implementation of Ste procodureo Compliance with procedure# end poAdeo Oavatoping new poMclee end procadurao Appiove / Review Computer Canter Security Plana Approve / Ravlaw ADP Application Security Plana Approve Headquarter# DOT, Computer OCCVDCA Eaiabiiah written phyetcal aacurlty alandaide X X X X X X X X XX X X __________ 1____ X X X X Oocumanl Control Proper Storage Activity Log* Sanitizing Stall Produced Oocumanla Accounting lor alt C8I related malarial uaad by contractora whan a contract ende. Destruction Reproduction fUceipl Initial Piocaaalng Dialnbulion Corifol X XX X XX X X XX XX XX XX XX XX Table E-2: LIST OF LOGS AND TRACKING SHEETS USED IN PROTECTING CBI Inventory Log User Sign Out Log Destruction Log Contractor/Subcontractor Sign Out Log Federal Agency, Congress, and Federal Court Sign Out Log Request for TSCA CBI Access Approval Request for TSCA CBI Computer Access Approval TSCA CBI Cover Sheet Telephone Contact Report TSCA Confidential Business Information Meeting Sign In Sheet Safe/Cabinet Security Check Sheet Request for Approval of Contractor Access To TSCA Confidential Businem Information Loan Receipt for TSCA Confidential Bttsinem Information 85 CMA 052302 Penalties for Accidental Disclosure of CBI though the legislative and statutory language assigns severe penalties for "wrongful* disclosure of CBI. most disclosures within EPA are accidental. In such cases, where the impact of the disclosure is not serious, most employees are not harshly penalized but are counselled as to their actions. Appendix I of the TSCA Confidential Business Security Manual lists informal corrective actions taken. They include: closer supervision, on-the-job training, and oral reprimands A serious violation may warrant rem vtng the employee from the Authorized Access List. Each cue is reviewed on an individual basis. A review of records of CBI violations maintained by the TSCA security staff indicates that most violations represent failures to follow procedures strictly, and are unlikely to result in the disclosure of CBI to unauthorized persons. Figure E-l shows that the overall number of violations is quite small, relative to either the number of CBI documents maintained by OPPT or the number of transactions involving CBI documents. By fir the greatest number of infractions represent tenures to abide by stria document-handling procedures, such as sending a CBI document to another authorized person using interoffice mail, or hand delivery of a document where the transmitter did not actually deliver the document into the bands of the recipient and obtain a signed receipt, or leaving a document within EPA in an improperly secured area. There were occasions on which CBI was placed into a public file or database, but a much greater proportion of infractions reflea situations in which drawers were not locked or audit trails on documents were incomplete. 86 CMA 052303 Figur E-1 immmi iiiimini V o m CM in o 1991 B 1990 B 1999 B 1998 ID 1987 B 1986 ED 1985 1984 B 1983 B 1982 1981 B 1980 Lost or iMssing Document Unlocked ES ou & & 1 APPENDIX F SCREENING INFORMATION DATA SET (SIDS) CHEMICALS KNOWN HUMAN CARCINOGENS IDENTIFIED BY NTT 89 CMA 052305 SIDS (Screening Information Data Set) Chemicals for which U-S. is lead country - Phase I and Phase II High Production Volume (HPV) Chemicals Phase l . 75-77-4 Silane, chlorotrimethyl 78-84-2 Propanal, '2-methyl 123-38-6 Propanal 504-60-9 1,3-Pentadiene 556-67-2 Cyclotetmitaonc, octametbyl 693-23-2 Dodecanoic add 2402-79-1 Pyridine, 23,5,6-tetrachloro . 25265-77-4 Propanoic add, 2-methyl, monoester with 2A4-trimethy-l,3-penianediol 29590-42-9 2-Propenoic add, isoooyi ester Ph*U! 78-93-3 Methyl Ethyl Ketone {Oral RfD in IRIS, Inhalation RfC in HEaST) - 108-10-1 Methyl Isobutyl Ketone (Oml RID and Inhalation RfC in HEAST) 111-11-5 Methyl capiylate 111-664) 1-Octene 111-82-0 Dodecanoic add, methyl ester 112-41-4 l-Dodeceae - 59241-6 1-Hexeoe 1120-36-1 1-Tetndeceae 2524-03-0 Dimethyl diiOTOthiopbosphate . 2524-04-1 Diethyl chlorothiopbosphate . 4259-15-8 Pbospbotodithiotc add, O,0-bis(2-ethylh CMA 052306 Chemicals with Nonmedical Uses That Were Identified as Human Carcinogens in the Fifth Annual Report on Carcinogens (NTP 89-239), 1989 {The most recent such report} 92-67-1 4-Aminobiphenyl 7440-38-2 Anenic.and Certain Arsenic Compounds 1332-21-4 Asbestos 71-43-2 Benzene Benzidine 542-88-1 Bis(chloromethyi)ether Also: 107-30-2 technical frade OUoromethyl Methyl Ether 7440-47-3 Chromium and Certain Chromium Compounds Key hexavalent compounds are: 10294-40-3 Barium Chromate 13765-19-0 Calcium Chromate 1333-82-0 Chromium Triaride 7758-97-6 Lead Chromate 10588-01-9 Sodium Diehromate 7789-06-2 Strontium Chromate . 505-60-2 Bis(2-chloroethyl)sulfide (Mustard Gas) 91-59-8 2-Napthylamine 1314-20-1 Thorium Diaride 75-01-4 Vinyl Chloride 4 CMA. 052307 CMA 052308 Federal Regiiter / Vol 57, No. 191 / Thursday, October 1, 1992 / Notices 45389 Issued in Washington. DC September 24, 1962. Charles F. Vacek. DeputyAssistant Secretary for Fuels Programs, Office ofFossil Energy. [FR Doc. 92-23871 Filed 9-30-92; 8:45 am] end Budget's (OMB) responses to Agency PRA clearance requests. FOR-FURTHER information contact. Sandy Fanner at (202) 260-2740. SUPPLEMENTARY INFORMATION: BIUJNO CODE *4iO-ei-il OMB Responses to Agency PRA Clearance Requests Office of Nuclear Energy OMB Approvals Early Site Permit (ESP) Demonstration EPA ICR No. 1050.04; Standards of Program--Siting Conference Performance for New Stationary agency: Office of Nuclear Energy, U.S. Department of Energy. action: Notice of meeting. Sources Storage Vessels for Petroleum Liquids - Subpart KA; was approved 05/29/92; OMB No. 2060-0121: expires 05/31/95. summany: Notice is hereby given that EPA ICR No. 1537.02; Human Activity the Early Site Permit Demonstration Pattern Survey: was approved 07/24/92; Program (ESPDP) will conduct a Siting OMB No. 2060-0045; expires 07/31/95. Conference on October 14,1992, The EPA ICR No. 1618.01; Request for purpose of the meeting is to present to Cement Kiln Dust Waste U.S. utilities, other potentially qualifying Characterization: was approved 07/29/ ESP holders, and the interested public, 92; OMB No. 2050-0123; expires 07/31/ results and status to date. These will 95. include discussions of ESPDP progress and other activities supporting the demonstration of the ESP process. EPA ICR No. 1615.01; Clean Air Act Rule Effectiveness Study; Regulation Compliance Survey - CAA Section 114; DATES: The conference will be held on was approved 08/10/92; OMB No. 2060- Wednesday, October 14,1992, from 8 0241; expires 04/30/94. a.m. to 5 p.m. EPA ICR No. 0226.09; Application for ADDRESSES: The conference will be held NPDES Discharge Permit and the at the Stouffer Concourse Hotel. 2399 Sewage Sludge Management Permit; Jefferson Davis Highway, Arlington. -was approved 68/17/92; OMB No. 2040- Virginia 22202, (703) 979-6800. 0086; expires 08/31/95. FOR FURTHER INFORMATION CONTACT. EPA ICR No. 1230.06; New Source Mr. Walter Pasedag. U.S. Department of Review and Prevention of Significant Energy. (301)903-3628. Deterioration Permitting Programs - Registration is required for attending Information Requirements; was the conference. To preregister, please approved 06/18/92: OMB No. 2060-0003; contact Southern Electric International expires 08/31/95. at (205) 868-5711. Registration is also available the day of the conference EPA ICR No. 0661.04; NSPS for Asphalt Processing and Asphalt Roofing beginning at 7:15 am. Registration the day of the conference is on a space available basis. The meeting is open to Manufacturing. Information Requirements - Subpart UU; was approved 06/18/92; OMB No. 2060-0002; the public. expires 08/31/95. William H. Young. Assistant SecretaryforNuclearEnergy. [FR Doc. 92-23889 Filed 9-30-92:8:45 am] eiOMu eooe mso-omi EPA ICR No. 0657.04; NSPS for Graphic Arts Industry (Subpart QQ) Information Requirements: was approved 06/18/92; OMB No. 2060-0105; expires 08/31/95. ENVIRONMENTAL PROTECTION AGENCY [FRL-4515-2] Agency Information Collection Activities Under OMB Review agency: Environmental Protection Agency (EPA). action: Notice. Summary: In compliance with the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et set).), this notice announces the Office of Management EPA ICR No. 1284.03; New Source Performance Standards for Polymeric Coating of Supporting Substrates; was approved 08/20/92; OMB No. 2060-0161: expires 08/31/95. EPA ICR No. 0029.05: NPDES Modification and Variance Requests; was approved 08/27/92; OMB No. 20400068: expires 08/31/95. EPA ICR No. 0601.09; Requirements for Generators, Transporters, and Disposers Under the RCRA Hazardous Waste Manifest System; was approved 09/02/92; OMB No. 2050-0039; expires 09/30/94. Conditional Approval EPA ICR No. 1616.01; Total Quality Management (TQM) Studies: OMB No. 2010-0023: expires 07/31/95. This collection of information received a conditional approval from OMB. For a copy of the notice containing the conditions, please call Sandy Farmer on (202) 260-2740. OMB Extensions of Expiration Dates EPA ICR No. 0262; RCRA Hazardous Waste Permit Application and Modification. Part A; OMB No. 20500034; expiration date extended to 12/31/ 92. EPA ICR No. 1571; General Hazardous Waste Facility Standards; OMB No. 2050-0120; expiration date extended to 12/31/92. EPA ICR No. 1573: Part B Permit Application. Permit Modifications and Special Permits; OMB No. 2050-0009; expiration date extended to 12/31/92. EPA ICR No. 0261; Notification of Hazardous Waste Activity; OMB No. 2050-0028; expiration date extended to 12/31/92. Dated: September 24.1902. Paul Lap*ley, Director, Regulatory Management Division. [FR Doc. 92-23880 Filed 9-3O-0Z 8:45 am] MUMCO0CIM94M OPPTS-00125; FRL-4167-3] Toxic Substances Control Act Confidential Business Information Claims Policies and Regulations; Notice of Meeting AOENCY: Environmental Protection Agency (EPA). ACTION: Notice of public meeting. SUMMANY: Notice is hereby given that a public meeting is scheduled to elicit public comments on Toxic Substances Control Act (TSCA) Confidential Business Information (CBI) policies and on a study commissioned by EPA which examined the influence of CBI requirements on TSCA implementation. Interested persons will be given the opportunity to comment on these policies, the recently completed study, and provide suggestions for proposals for future actions in this area. DATES. The public meeting will occur on October 14,1992, from 9:30 a.m. to 12:30 pjn. Persons wishing to attend the meeting should contact the party listed under FOR FURTHER INFORMATION CONTACT before October 7,1992. ^ 052309 45390 Federal Register / VoL 57. No. 191 / Thursday. October 1, 1992 / Notices ADDRESSES: The public meeting will be held at: Washington Vista Hotel, 1400 M St.. NW.. Washington. DC 20005. FOR FURTHER INFORMATION CONTACT. Scott M Sherlock, Information Management Division (TS-793), Environmental Protection Agency, 401 M St., SW., Rid. -118, Washington. DC 20400. Telephone: (202) 260-1536. TDD: (202) 554-0551. SUPPLEMENTARY INFORMATION*. In early September 1992. EPA released a commissioned study titled "Influence of CB1 Requirements on TSCA CBI." This study W8s commissioned as part of an EPA initiative to improve TSCA's utilization as a toxics information dissemination statute. The Study provided an depth analysis of CBI claims, submitter procedures for making such claims, Agency review and challenges of claims, and effects of improper claims on EPA's toxics information mission. Using this study as a first step, EPA is reviewing CBI claims procedures to establish a more effective way to provide the required protections to business confidential information and also to further TSCA's usefulness as a toxics information dissemination statute. The Agency in this public meeting is seeking public comment on TSCA confidential business information handling policies, TSCA information dissemination policies, and soliciting perspectives and suggestions for the next steps to be undertaken to make the TSCA confidential business information dissemination systems more effective. Persons wishing to attend die meeting should contact Scott Sherlock at (202) 260-1536 in order to preregister. Members of the public will be granted the opportunity to make oral comments at the meeting. Individual comments will be limited to 5 minutes. Written comments are invited and should be directed to Scott Sherlock at the address listed under FOR FURTHER INFORMATION CONTACT. Dated: September 24,1992. Linda A. Travers, Director. Information Management Division. Office ofPollution Prevention and Toxics. |FR Doc. 92-23858 Filed 9-30-92; 8:45 am] ammo coca awe w r FEDERAL MARITIME COMMISSION Elizabeth Rtver Terminate, Inc., et at; Agreements) Filed The Federal Maritime Commission hereby gives notice that the following agreements) has been filed with the Commission pursuant to aection 15 of the Shipping Act. 1916, and aection 5 of the Shipping Act of 1984. Interested parties may inspect and obtain a copy of each agreement at the Washington DC Office of the Federal Maritime Commission, 1100 L Street. NW., room 10325. Interested parties may submit protests or comments on each agreement to the Secretary, Federal Maritime Commission. Washington DC 20573. within 10 days after the date of the Federal Register in which this notice appears. The requirements for comments and protests are found in tS 560.6 and/or 572.603 of title 46 of the Code of Federal Regulations. Interested persons should consult these sections before communicating with the Commission regarding a pending agreement Any person filing a comment or protest with the Commission shall, at the same time, deliver a copy of that document to the person filing the agreement at the address shown below. Agreement No: 224-008435-001, Title: Terminal Operators Conference of Hampton Roads. Parties: Elizabeth River Terminals, Inc. Lambert's Point Docks, Inc. Virginia International Terminals, Inc. Virginia Ports Authority. Filing Party: H. Robert Jones. Chairman, Virginia Port Authority, 600 World Trade Center. Norfolk, VA 23510. Synopsis: The subject modification would restate and update the Agreement by-acknowledging its effectiveness under the Shipping Act of 1984, expand its geographic scope, change its name, and make administrative changes within the voting provision. Agreement No: 207-011381-001. Title: United Yacht Tranaport Joint Service Agreement Parties: Dock-Express Shipping B.V. Wijsmuiler Transport Holding B.V. Filing Party: Edward Schmeltzer, Esq., Schmeltzer. Aptaker & Shepard. P.C. 2600 Virginia Avenue, NW., Washington. DC 20037-1905. Synopsis: The proposed amendment adds Alaska and Hawaii to the U.S. port areas served, expands the Agreement's authority to Include U.S. domestic service for the carriage of yachts between the U.S. Virgin Islands and other U.S. porta, and provides for the carriage of watercraft other than yachts between Mediterranean ports, Florida, and the U.S. Virgin Islands. Dated: September 25.1992. By Order of the Federal Maritime Commission. Joseph C. Polking, Secretary. (FR Doc. 92-23761 Filed 9-30-92: B-.45 am| KUiNo cooe sno-oi-a The Port of Oakland et at.; Agreements) Filed The Federal Maritime Commission hereby gives notice of the filing of the following agreement(s) pursuant to section 5 of the Shipping Act of 1984. Interested parties may inspect and obtain a copy of each agreement at the Washington. DC Office of the Federal Maritime Commission, 800 North Capitol Street NW,, 9th Floor. Interested parties may aubmit comments on each agreement to the Secretary. Federal Maritime Commission, Washington, DC 20573, within 10 days after the date of the Federal Register in which this notice appears. The requirements for comments are found in 5 572.603 of title 46 of the Code of Federal Regulations. Interested persons should consult this section before communicating with the Commiasion regarding a pending, agreement. Agreement No.: 224-003914-007. Title: Port of Oakland/Sea-Land Service. Inc.. Marine Terminal Agreement. Parties: The Port of Oakland ("Port'') Sea-Land Service, Inc ("Sea-Land"). * Synopsis: The Agreement provides for certain container yard repair improvementa to be performed by SeaLand at the Pori. It also provides for reimbursement by the Pori to Sea-Land of a portion of the cost for container yard improvement Agreement No.: 224-200294-005. Title: Georgia Ports Authority/ Japanese Three Lines Terminal Agreement Parties: Georgia Ports Authority Mitsui O.S.K. Lines, Ltd. Nippon Yusen Kaisha. Synopsis: The amendment revised the Agreement's rate schedule. Agreement No.: 212-011213-029. Title: Spain-Italy/Puerto Rico Island Pool Agreement. Parties: Compania Trasatlantica Espanola, S.A. Nordana Line A/S Sea-Land Service, Inc. Synopsis: The proposed amendment will reduce the amount of the security CMA 052310 draft TEXT FORMAT In the pact fv years, many controversial 1mui have benefited^ from public dialogue between government, industry and other interested parties. CM baa participated fully in these dialogues and has learned, as we believe EPA has, that cooperative relationships are sore productive than adversarial ones. Of course, this cooperation should be professional and nest a high degree of ethical standards. I call this type of relationship "skeptical partners" towards the sane goal. It should be clear that SPA and industry have the sans goals. A safer world with constant risk reduction. CMA's Responsible Cere program is our public expression and effort towards these goals. I am afraid that I must announce to this audience the report wa are hare to diaousa has struck a nerve. The tone of the report is typical of "industry bashing" and leek of attempt to understand tha nsads of industry which Characterised SPA in days we thought we have seen the lest of. Tha subject of the report, trade secret information, addresses tha lifeblood of the American economy and tha competitiveness of American industry. CMA companies believe vary strongly that rigorous protection of CBI information under TSCA needs to continue. How that it is clear that both industry and ZPA have significant eonoems, let ua go on to really listen to each other and coma up with an equitable aolution to the peroaived problem. Let's broach the subject by discussing TSCA itself. TSCA has been under e lot of criticism - by public interest groups. Congress and SPA. Much of this has corns to light over the recent judicial decision on the asbestos ben. industry however is lass critical of TSCA aa a statute. That does not moan that it is a one-sided law, it is a law which places significant burdens on industry. But industry has learned to live with the burdens of TSCA; moreover, industry has grown to appreciate tha implicit fairness built into the statute. Checks and balances adequately assure that SPA baa sufficient power to protect human health and tha environment while burdens to industry are considered and confidentiality of proprietary information is protected. Share industry is mors critical of TSCA is in tha way the agency manipulates its power under TSCA. interpretive and procedure1 rulemaking is lacking, SPA substitutes unwritten and unpublished policy which is allowed to drift towards tighter regulation and mors reporting. There really is too much information and misinformation in the Hampshire report on CBI experience to adequately respond to at this tjjM. CMA will submit a complete rebuttal of this report at a later date. But let me try to relay to you some first impressions on the Hampshire report and the perspective of tha regulated Industry on CBI. CMA 052311 =*cr> ',p ^*1 ST :CT TC, Q? draft BULLET FORMAT nil PROTECTION IS A SUCCESSFUL EPA PROGRAM BPA haa dona wall protecting tha CBI of Induatry. Pointa to illuatrate thla auooaaa include! 1. Ho aeandala or oonplainta have boon evident that SPA haa boon lax in the protection of CBX or lnadvartantly ralaaaad CBX. IPX haa dona a great job. a. BPA baa aueeaaafully managed to adalniatar tha Act with CBX. - SPA baa aueeaaafully iaplaaantad tha confidential T8CA Inventory, and bonafide raquaet prograa, SNURa, ate. - SPA has auooaaafully iaplaaantad prooaduraa which have induatry eubadt 'sanitised oopy" of aubaiaeiem for public docket. 3. SPA baa begun enforcement action on aanufacturara who unauooaaafuily triad to oopy ooapetitora products and rely on ooapatitera* indication of T8CA compliance rather than cheeking tha confidential inventory. 33JT",>C'!P" up 7~\ 0?:gi CHA 052312 draft COMMENTS ON EPA'S HAMPSHIRE CBI REPORT The report i ona-fldad, unobjective, unprofessional, and biMd in ita ton*. The contractor did not make adequate efforts to interview industry. Tha contractor did not attempt to separate statistics on CBI claim* on R4D ehaaieala and commercial chemicals. comparison with other statutes incomplete. FDA and osha regulations more germane to products on tha market than ml. Tha contractor does not understand that BFCRA chemicals are common commodity chemicals while all industry specialty performance Chemicals ere subject to TSCA. EPA*s success in challenging CBI claims in flection 8(e) reports is presented in e biased end incomplete manner. Contractor did e good job brainstorming possible solutions. Contractor subjectively eliminated options based on little data. Alleged benefits to public of increased information disclosure not explained in depth. ^__r * *v* in T*:ct CMA 052313 DRAFT TSCA IS NOT PRIMARILY A BIGHT-TO-KNOW STATUTE - Main job of SPA under TSCA is to review end evaluate information from Industry end take neosasary actions to protect public health and the environment. - Public is not capable of understanding most TSCA report* end has demonstrated little interest in TSCA information. - Information normally made public on TSCA submissions is adequate for public to find real problems. Sxamplss ere as follawst 1. Results of tox date on PMMe ere published in the Federal Register. Based on this information, public could identify PMMe which may be of concern. 2. Preambles of 8MUR proposals discuss problems in more depth than on routine PHMa. This contains adequate information for public te express any eoncarn. 3. Past publication of Section 8(e) status reports were an excellent public information tool. Routine follow-up by SPA regarding voluntary actions by Section 8(e) submitter were an excellent prod to assure information wee passed on to workers. So both the public and worker right-to-knov aspects of Scotian 8(e) reports were adequately oovered by KPA. Lately it appears that EPA has discontinued publishing Status Reports and has not kept up with routine follow-up with Ssotion (e) submitters. - TSCA reports ere an inappropriate means of plsoing data in public scientific literature. Voluntary publication in peer reviewed journals is the proper means. s S0p - _t T T^O T Ii/q CMA 052314 DRAFT SUMMARY OF CMA POSITION ON CBI UNDER TSCA - Protection of CBI is critically important to tha competitiveness of tha tJ.fi. chemical industry. - Tha public's right-to-know naada to ba balanced with industry's property rights and only In critical situations should CBI olaias be challenged. - epa does a good job of protecting CBI. - bpa does a good job of administering TSCA around CBI raquiraeanta. Tha ralaaaa of more CBI will not ba of great interest or great benefit. - The public has shown little interest in TSCA data end decisions. CBI provisions of other laws help protect trade secrets of tne ohanioal industry, and unilateral ralaaaa of CBI under tsca will not ba aa informative aa EPA asserts. T8GA la not primarily a Uight-To-Knov statute. Tha primary purpose of TSCA is for KPA to review information and tamo action to protact public health and tha anvironmant. - TSCA raporta and SPA dsciaiona should he available to the public. Protection of CBI information does little to detract from their usefulness. EPA has tha responsibility to tabs complex TSCA reports end put than in a form that is understandable to tha public. (Tha Section s(a) status reports did that!) - Tbs main um of TSCA publlo dockets is industry espionage. - CBI claims on PMN chemicals and RfiD chemicals are usually legitimate, and this should ba intuitively obvious to KPA. - The over reporting of information under Section 8(e) which has bean demanded and enforoed by KPA, unfairly pitta CBI information at risk, and interferes with SPA* a ability to protect end inform the public. Reverse engineering is a difficult process, eeastpecially of complex mixtures, and errors of reverse engineering which have lad to TSCA violations have bean reported* Patent strategy of 0.8. industry is complex and tha existence of a patent should not necessarily compromise the sbility of Information to be considered CBI. CMA 052315 draft COMMENTS QN POSSIBLE SOICTIONS - Arbitrary sunset time periods era unfair. Manufacturers should ba allowed to claim CBI for aa long aa steps ara taken by manufacturer to aetivoly protact information. - Industry nay ba willing to support raasonabla fees and reasonable resubstantiation reporting to saintain CSX protaction* - Adainiatrator haa aufficiant powar undar T8CA to foroa tba ralaaaa of CBI to protact public health and environaant. - Industry say ba willing to support public and customer notification raguirasanta of Section i(e) retorts if SPA would return to a definition of "aubatantial risk" which sore accurately mirrored congreaeional intent and matched the urgency of "immediate reporting" - SPA needs to do a battar job of digeating eomplax information and reporting it to the public in an understandable fashion. - Itaport cards on company claims ara an intaresting idea. Industry haa fait compelled to ahbanea its image and raduca aaiaaiona dua to TXI reporting and its public availability. Companies which claim CSX in a high percentage of reports would than need to explain to workers# customers, and plant neighbora. - SPA enforcement is a useful tool - industry fears large penalties, cases Should ba chosen not only on degree of egragioueness# but also by relative risk to health or environment indicated by report or case in question* CMACBX.FOS ajJ'--JITir -7T Z?:T CMA. 052316