Additional benefits accrue from certain changes in report timing and information elements that enhance consistency and linkages with other EPA databases. EPA also expects a reduction in the number of CBI claims by submitters, more accurate chemical tracking, and an increased ability to 35 Databases and the literature sources commonly reviewed by EPA are described in Appendix B.

V 13 anticipate industry trends. Finally, the proposed removal of one reporting exemption and the addition of other partial reporting exemptions are expected to provide an increase in net benefits by reducing costs more than any benefits are reduced. In other words, benefits associated with information collected on the partial reporting exemption chemicals is expected to be less than the costs associated with collecting that information, therefore resulting in an increase in net benefits.

The social benefits resulting from the proposed amendments are qualitatively discussed in this chapter. This chapter is organized as follows:

Section A contains a review of the benefits associated with improving EPA's chemical screening accuracy and timeliness, Section B focuses on the benefits of less frequent CBI claims, Section C contains an analysis of the benefits associated with proposed changes in certain exemptions, Section D focuses on certain administrative changes and related benefits,

andSection E contains a brief analysis of the impact of each specific option on the benefits of the amendments.

A. Benefits from Use and Exposure Data The use and exposure data collected through these amendments will fill an existing information void; neither the EPA nor the public have access to these data. 35 Use and exposure data will allow EPA to improve its chemical screening process, enabling the identification of chemicals of potential concern due to specific uses or exposures, the earlier identification of potentially risky chemicals, and a more effective screening process and chemical management program. EPA will be able to provide the public with any non CBI information and with the results of any analyses. The public will get risk information they previously did not have  and they will get it sooner.

The amended IUR data will allow EPA to pre screen chemicals, allowing a quicker and more comprehensive risk screening to occur. In addition, because better data will be available for the prescreening process, EPA will be able to effectively target the chemicals referred to a more detailed screening process, thereby reducing the number of more detailed reviews that result in chemicals dropping out of the risk management process due to a low level of concern. Consequently, appropriate V 14 chemicals will enter EPA's risk management programs sooner, enabling EPA to disseminate risk information to the public that they otherwise would not have had or allowing EPA to take other necessary actions to reduce the incidence of morbidity and mortality from chemical exposures. In addition to identifying potential risk situations in a more effective manner, this information allows EPA to operate more efficiently, making better use of the available resources. Not only will better targeting of projects occur, but EPA will reduce the resources spent on the projects which do not lead to real risk reduction.

Other risk management programs and activities will also benefit from the available use and exposure data. Although EPA expects that OPPT will be the largest user of the data, a number of other Federal,

state, public group, and industry programs will benefit from the information, as well.

Another benefit of the IUR amendments is the facilitation of database linkages. The enhanced facility identification information and the changes to calendar year reporting will improve the ability to combine IUR data with other information. This will lead, in some cases, to the development of a more complete picture of the risks posed by these chemicals. In addition to identifying risks, EPA will be able to use the use and exposure related data, combined with a source of release data such as TRI, to check the validity of various models. This will allow EPA to do a better job of predicting exposures for all the other chemicals that do not have exposure data. As EPA improves its use of data and improves the accuracy of its exposure predictions, society benefits through the EPA's use and dissemination of improved information, enabling both the EPA and the public to make decisions based upon that improved risk information.

Another benefit of the IUR amendments is the reduction in the number of CBI claims. Currently,

a great deal of the information reported through the IUR is claimed as TSCA CBI. These claims restrict the usefulness of information to EPA and other users. Two proposals are expected to reduce the number of CBI claims. The proposed up front substantiation requirement forces the reporter to more carefully consider the facility identification CBI claim. The proposed production volume range CBI checkbox allows the reporter to determine if the production volume range is CBI, separate from the CBI status of the exact production volume. The third proposal reduces the amount of information remaining CBI over time. The proposed reassertion requirement requires the reporter to review past CBI claims and determine if they are still valid. If CBI protection is no longer required, the information will no longer be treated as CBI. These changes increase the amount of information available to the public and other V 15 users and gives the EPA more flexibility in its use of the information. EPA expects that the remaining CBI claims will be essential and will address real concerns, as opposed to some past CBI claims that were based more on habit than necessity.

The following sections review OPPT's current risk screening programs and chemical management programs, and describe the benefits these programs will gain from the enhanced information. They also describe how the information can be used by other programs and other agencies.

1. Benefits to OPPT Risk Pre Screening, Screening, and Management Programs OPPT has a multifaceted approach to managing chemical risks, as illustrated in Figure V 1.

Chemicals enter OPPT's system by a number of methods  pre screening by OPPT, a request by the Interagency Testing Committee, or a request by the public. The chemicals then go through one of several more detailed screening programs, such as the RM1, Master Testing List ( MTL) or Use Cluster Scoring System ( UCSS) programs. Depending on the outcome of these screening processes, next steps may include entering one of EPA's risk management programs. Each of these phases, and the benefits derived from the proposed use and exposure information, are examined below.

a. Expected Use of Data EPA will use the exposure related data to estimate potential exposures. Some of the ways in which the specific information collected through these amendments would assist in the risk prescreening screening, and management processes are identified below. Additional information on the usefulness of this information can be found in the EPA report entitled " Inventory Update Rule ( IUR)

Technical Support Document: Exposure Related Data Useful for Chemical Risk Screening, Volume I."

Number of Potentially Exposed Workers  Estimates of the number of workers potentially exposed to specific chemicals would be used to develop worker exposure scenarios. The number of workers is combined with the chemical function, the chemical form, the chemical concentration, and other information to develop these scenarios.

NAICS Code  The NAICS code enables EPA to sort and screen information by industry sector. Specific industry sectors often have particular ways in which they handle, use or manage chemicals; these ways affect the potential for exposures. As part of the risk screening process, EPA can also identify those industries which might be good candidates for pollution prevention and control activities.

Function Code  The industrial function of a chemical substance can be an important indicator of potential chemical exposures  to the workers, the environment, and the general population. It will also be useful for estimating the potential frequency and duration of exposure. V 16

Known Commercial or Consumer End uses  Information on the use of chemicals in commercial and consumer end use categories would be used to estimate the potential exposure. Generally, these populations are regarded as large and not well protected.

Maximum Concentration  Information on the maximum concentration of a chemical present at a manufacturing or processing site, or used for commercial or consumer purposes, would be used to estimate the potential level of exposure.

Number of Sites  Information on the number of sites where a chemical is manufactured or processed will provide information on the level of exposure potential for workers and the community in general.

b. Benefits to Chemical Risk Screening and Management Programs OPPT uses a number of tools to manage and evaluate chemical risk. These tools include various levels of risk screening and subsequent management. Risk screening involves a broad look at potential hazards, exposures, and releases based on production volume, patterns of use,

and the number and types of potentially exposed populations. Risk screening is less detailed and focussed, and requires less data, than risk assessment. V 17 Figure V 1. Flow of Chemicals Through OPPT's Screening and Risk Management Programs Modes of Entrance to the OPPT Screening System OPPT Pre screening Interagency Testing Committee Request Public Request Risk Management Programs Existing Chemical Review Program Design for the Environment   Current Screening Programs New Chemical Review Program Existing Chemical Review Program Master Testing List Use Cluster Scoring System Environmental Indicators OPPT uses two levels of screening  pre screening and screening, as depicted in Figure V 1. In these efforts, OPPT currently combines hazard ( when known) and production volume information to evaluate chemicals for risk. By using production volume as a proxy for exposure, however, EPA is not incorporating other factors involved in determining exposure. These factors include chemical use, the number of potentially exposed workers and consumers, the number of use sites, chemical concentration,

and production and use exposure controls. Consequently, EPA has recognized that additional data including detailed information on exposure scenarios are needed to adequately pre screen and screen V 18 chemicals on the basis of risk. As described in Box V 1, the proposed IUR amendments will allow for enhanced information collection, thereby benefitting EPA's chemical risk screening programs and increasing the efficiencies of the tools used in these programs.

Better risk screening ultimately generates opportunities for improved risk management by EPA and other entities. Box V 1 also presents OPPT risk management programs that might benefit from the greater scope and depth of data the IUR amendments will produce, including the Existing Chemical review process and various pollution prevention, risk reduction, and chemical testing programs, such as the Design for the Environment ( DfE), and the Chemical Testing Program. EPA expects that the exposure data collected through the proposed amendments also would be useful to a variety of other OPPT programs or initiatives, including the Source Reduction Review Project, § 8( e)/ CAP activities, the New Chemicals Program, and TSCA § 9 referrals.

The additional data generated by the proposed IUR amendments can expedite and improve risk determinations and help OPPT's chemical risk screening and risk management programs to become better focussed and more efficient. Table V 1 summarizes the potential benefits to EPA's pre screening,

screening, and risk management programs from the data proposed to be collected under the IUR amendments. The importance of each information element to each of the programs is indicated by the number of check marks in the table. Agency activities could achieve risk reductions and cost savings through:

more rapid identification of potentially high risk situations, and more effective goal setting and targeting of resources in regulatory and non regulatory activities; V 19 Box V 1. EPA Tools to Evaluate and Manage Chemical Risk Risk Pre Screening. OPPT pre screens chemicals on the TSCA Inventory to identify potential risks and determine whether more detailed screening analyses should be undertaken through the RM1 program. With the data currently available, EPA does not have the information needed to effectively and systematically pre screen some of the chemicals on the inventory. Data collected as a result of this proposal would improve the Agency's ability to provide a more accurate pre screen of chemicals in commerce, allowing the Agency to focus its chemical screening programs and to identify risky situations earlier than otherwise possible. This would allow EPA to expend resources more efficiently and reduce the number of occasions where resources are allocated for assessment of chemicals that ultimately pose low risk.

Existing Chemicals Review Program. The Existing Chemicals review program conducts detailed analyses of high risk chemicals and develops strategies to reduce or eliminate the exposure risks. Chemicals are first screened to identify those that ( 1) require additional testing, ( 2) present potentially significant risk management concerns, or ( 3) do not currently require further review. Use and exposure data collected through the proposed IUR amendments would contribute to this risk management program in several ways. First, improved screening prior to RM1 would lead to a quicker identification of chemicals of concern and more appropriate entry into EPA's chemical management programs. Second, the proposed IUR amendments would provide readily obtainable initial use and exposure information for these chemicals, significantly improving the efficiency and effectiveness of RM1 screening. Finally, by effectively weeding out the lower risk chemicals sooner, EPA would be able to focus efforts on higher risk chemicals.

Environmental Indicators. The OPPT has created a computer model that can trace the potential impacts of Toxic Release Inventory ( TRI) chemical emissions on human health and the environment. The model can aid in the identification of chemicals of significant risk. The Indicators reveal how the impacts of the TRI chemical releases change each year. Factors considered in the model include TRI release and transfer volumes, chronic toxicity, exposure potential, and affected populations. The proposed IUR amendments would provide another source of the chemical data that are used by the model to determine outputs such as pounds of release and surrogate exposure.

Use Cluster Scoring System ( UCSS). The Use Cluster Scoring System ( UCSS) identifies potential risks of chemical substances used in similar applications, or " use clusters." This system enables the Agency to view the risks of a given chemical substance in the context of the risks presented by related products on the market and allows the Agency to establish regulatory review priorities for those use clusters. However some of the UCSS data sources are outdated and estimating methodologies are speculative. The proposed amendments would create a database providing additional information that would allow the Agency to provide more accurate screening level estimates for use clusters, targeting Agency programs to areas currently needing attention. It will also enable the Agency to more easily conduct broader chemical screening analyses across several industries.

Existing Chemicals Testing. TSCA § 4 empowers EPA to require manufacturers and processors of chemicals to test the chemicals they manufacture and process to obtain hazard data necessary to assess the chemical's risks. EPA must make findings under either § 4( a)( 1)( A) (" A" finding) or § 4( a)( 1)( B) (" B" finding) before testing may be required of a manufacturer or processor. The A finding permits EPA to require testing on a " may present" risk basis; the B finding can be made on an exposure basis. For the B finding, use and exposure data would be a critical input when no hazard data are available to indicate a chemical's toxicity. In addition, OPPT uses the Master Testing List ( MTL) of chemicals identified by the Agency as having inadequate data for health and/ or environmental risk assessments. OPPT uses the MTL to establish priorities for chemical testing, keep the public informed, and solicit input from industries on specific chemical exposure and risk assessment needs and encourage them to perform testing. IUR data would facilitate these efforts by targeting testing needs to situations in which potential risky exposures are known to occur, thereby increasing the efficiency of efforts in these programs and facilitating earlier completion of critical testing needs.

Screening Information Data Set ( SIDS). SIDS is a voluntary program, conducted under the auspices of the OECD, which allows member countries to share the burden of testing internationally traded large production volume chemicals. The U. S. is responsible for testing of 25 percent of the chemicals identified for the Program. The information needed is collected by industry sponsors, however the data elements collected may not be consistent across sponsors, and some companies may not participate in developing information. The proposed amendments would provide many key needs for exposure data and would provide a consistent database of information from manufacturers and importers. This information would increase the program's efficiency by helping to identify chemicals requiring additional testing or assessment while excluding those with low domestic exposure. A better exposure database would also improve evaluation of potential risk in the assessment reports prepared at the end of the SIDS process.

Design for the Environment ( DfE). The Design for the Environment ( DfE) program incorporates principles and strategies from both the Existing Chemicals review program and the UCSS, by focusing on specific chemical uses and establishing partnerships with industry to develop voluntary long range plans for risk management. The exposure related data collected through the proposed IUR amendments would help to identify use cluster candidates for this program. It would also provide the initial assessment of exposures and help identify potential substitutes, and could be used to assist in ranking activities, identifying high risk areas, and developing realistic approaches for reducing risk. V 20

identification of potentially high risk situations which otherwise might not be identified;

rapid deployment of resources to initiate or expand pollution prevention efforts in the private sector;

timely and effective identification and development of safer substitutes and alternative chemicals, processes, and technologies;

development of more complete data for public use; and

identification of opportunities to avoid costly regulatory analyses or rulemakings by developing voluntary agreements, by delegating authority to state governments for situations in which high risk exposures are limited to a few sites or a single site, or by engaging other regulatory agencies such as OSHA, CPSC, and DOT to control risks that they are best able to address.

Table V 1. Benefits to Existing OPPT Programs of Chemical Processing and Use Information Collected under the Proposed IUR Amendmentsa Program Chemical ID Company ID Industrial Processing and Use Information End Use Data Exposure Data Production Volume and Import Data RM1 Process

Use Cluster Scoring System ( UCSS)

Design for the Environment ( DfE)

Master Testing List ( MTL)

Screening Information Data Set ( SIDS)

Existing Chemicals Review Program

Other Federal Risk Management Programs

State and Local Programs

Responsible Care

a One check in the box signifies that the information is important, two checks indicate that the data are critical.

c. Illustrative Quantitative Assessment of Benefits From Processing and Use Data The primary benefit of the new use and exposure related information is derived from OPPT's ability to facilitate pre screening activities for chemicals that may require intervention to mitigate risks. The information also benefits downstream risk screening and management activities under RM1 and other programs. The sections below provide a qualitative and quantitative assessment of how the proposed information collection would improve the efficiency and outcome of these programs. V 21 i. More Rapid and Effective Pre screening: Real Resource Savings As described in Section b above, pre screening of chemicals is an essential first step in determining priorities for more detailed risk screening and later risk management activities. The proposed rule will make the process by which chemicals enter EPA screening and management programs more effective and rapid. By eliminating from consideration chemicals that pose lesser risks, EPA can focus resources on chemicals posing higher risk. More effective pre screening of chemicals will not only prioritize the chemicals entering screening and risk management programs, but will also better target the resources devoted to these activities, as described below.

Equally important, the information on uses and exposures will allow EPA to make determinations for some chemicals for which determinations currently are not possible. Because of the paucity of data,

these chemicals are never identified for later risk screening or management activities, nor are they eliminated from consideration. These chemicals pose the greatest obstacle for EPA because no action is possible. By making available the use and exposure information proposed under the IUR amendments, OPPT can make pre screening determinations for these chemicals and thereby identify potential risk concerns to human health and the environment.

The resources that could be saved by improving the pre screening process and thereby reducing the number of chemicals entering the screening process can be roughly estimated by examining the TSCA Inventory and screening needs. The Inventory and Inventory Update processes provide production volume information for chemicals that is then used to screen chemicals for exposure risks.

Based on these data, EPA has been able to determine that further information is not needed at this time for a large portion of the 75,000 chemicals on the TSCA Inventory. However, for about ten to fifteen percent of those chemicals, additional information is required to adequately assess the potential risks at a screening level. This proposed amendment will collect manufacturing level information on 8,900 of these chemicals and detailed use and exposure for approximately 6,000 of these 8,900 chemicals.

By allowing EPA to pre screen these chemicals more effectively, the proposed IUR would reduce the number of chemicals entering screening processes ( including RM1) and thereby reduce the resources required to screen and evaluate chemicals. Assuming, as per Box II 4 ( See Chapter II), that these activities require 100 hours per chemical, reducing the number of chemicals that enter the screening process could result in savings of many FTEs, over time. For example, if, as a result of the V 22 prescreening due to this new information, the number of chemicals entering RM1 is reduced from 6,000 to 3,000, savings of 300,000 hours or 144 FTEs would result. In addition, savings in extramural ( contract) dollars and savings in industry costs ( due to EPA not contacting industry to determine information on those 3,000 chemicals) would also be realized. The resources required to conduct both the pre screening and the RM1 screening on a per chemical basis will fall as a result of the proposed rule, thus further conserving government resources. Even after the prescreening step, it is unlikely that these remaining 3,000 chemicals of significant risk would complete a screening in the near future,

considering that the present rate of review is approximately 100 chemicals per year. It would take 30 years for 3,000 chemicals to enter and complete the RM1 process. The use and exposure information available under the proposed IUR amendments would accelerate this process. In the absence of the prescreening step, the original 6,000 chemicals would not receive a detailed evaluation within a feasible time period.

ii. More Rapid and Effective RM1 Screening: Time Savings EPA established the TSCA Inventory and, subsequently, the Inventory Update process to collect production and facility information on chemical substances in support of EPA's efforts to satisfy TSCA requirements of protecting human health and the environment. The information collected through these programs is central to EPA's efforts to screen chemical substances to identify those that might pose unreasonable risks, ultimately supporting EPA's efforts to mitigate those risks using a variety of regulatory and non regulatory mechanisms.

The time and effort required to collect and process data or to develop exposure estimates will also be reduced with the availability of information proposed to be collected under the IUR amendments.

EPA will also be able to conserve resources and focus efforts on chemicals that potentially pose higher risks. Under the amendments, EPA will be prescreening reported chemicals with production levels above 25,000 pounds every four years. At each data collection, the top 100 chemicals with the greatest potential for risk can be subject to more indepth evaluation. Between data collections, EPA will examine,

at minimum, the top 400 chemicals with potential for risk. The frequency of reporting cycles under the proposed amendments allows EPA to track changes in the usage of high priority chemicals. This approach offers advantages over a one time data collection and certainly provides better information V 23 than relying on previously collected chemical use data that may be outdated. The potential magnitude of the benefits of more rapid screening and risk reduction resulting from IUR reporting under the amendments can therefore be illustrated using the RM process as an example. Between 1990 and 1994,

1,924 chemicals were identified as candidates for the RM process and 561 chemicals proceeded through RM1 an average of 112 chemicals annually. It is reasonable to assume that a similar number of chemicals will be reviewed in future years if the IUR is not amended.

As in the case of pre screening activities, there would be government resource savings associated with the facilitated and more rapid review of chemicals that do enter the process. Moreover,

the additional use and exposure data would facilitate subsequent risk management activities as well,

potentially allowing EPA to keep pace with the increased outflow from RM1 decisions. Consequently,

throughout the pre screening, screening, and risk management processes, EPA would be able to make better, more efficient use of public dollars in OPPT programs.

iii. More Rapid and Effective RM1 Screening: Potential Lives Saved By speeding up the process by which chemicals are screened and evaluated through the risk reduction process, the additional use and exposure information could result in human and ecosystem risk reductions occurring years earlier, with concomitant reductions in mortality,

morbidity, and ecosystem damages.

Based on the above discussion, it appears reasonable that, as a result of the proposed IUR reporting rule, risk management processes at EPA could result in real reductions in mortality, morbidity,

and ecosystem damages because results would be available many years earlier than otherwise.

Because the ultimate outcome of the chemicals to be evaluated or managed in EPA's screening and risk management programs in the future is unknown, it is difficult to translate the benefits in terms of a more rapid process into a quantitative estimate of lives saved, illnesses averted, or ecosystem damages avoided. Moreover, risk management activities result in both costs and benefits to society. Thus, in addition to improving the effectiveness and timeliness of screening, the downstream benefits of the proposed IUR are the net benefits of risk management activities that occur sooner than they would have occurred in the absence of the rule. V 24 Ideally, the net benefits of the proposed rule would be assessed in several steps. The first step is to determine the likely outcomes of risk management activities that might be undertaken in the absence of the proposed rule, and the annual costs ( in terms of industry actions) and benefits ( in terms of lives saved and other environmental and health benefits, such as reduced morbidity) associated with these activities. This step would produce a measure of present value net benefits associated with risk management activities, in the absence of the proposed rule. The second step is to duplicate the present value net benefit calculation, but assume that risk management activities occur earlier under the proposed rule than they would occur in its absence. The third step is to calculate the incremental benefit of earlier risk management activities that occur under the proposed rule, i. e., the difference between present value net benefits calculated with and without the proposed rule. This incremental benefit results from the additional years of risk management activities that occur because the activities begin earlier.

Finally, the net benefits of the proposed rule would be calculated by subtracting the present value of the costs of the rule from the incremental benefits of earlier risk management activities.

Data limitations, however, make this ideal approach difficult to implement. In particular, it is difficult to assess what the net benefits would be of any activities to address or mitigate risks subsequent to the screening activities. Although a number of existing chemical rules have been promulgated under TSCA or other authorities ( e. g., EPCRA), and other programs such as DfE are ongoing, it is difficult to generate an estimate of net benefits, or even non monetized reductions in morbidity and/ or mortality, per chemical addressed. Furthermore, not all chemicals that enter the risk management process ultimately warrant actions to reduce risks. For both these reasons, it is difficult to quantify the net benefits that are likely to result from any risk management activities that could be accelerated by the proposed rule.

2. Benefits to Non OPPT Risk Management Programs In addition to OPPT, other public and private organizations are actively involved in managing chemical risks. These include other EPA programs, the Consumer Product Safety Commission ( CPSC), the National Institute of Occupational Safety and Health ( NIOSH), the Occupational Health and Safety Administration ( OSHA), Department of Defense ( DoD), state and local governments, and the private sector. Given the large number of chemicals and potential exposure scenarios at the industrial, occupational, and consumer level, these organizations also require more complete use and exposure information to effectively and efficiently manage chemical risks. Because of V 25 CBI claims, not all of the information will be available to these other potential users. This is mitigated, in part, by proposals in the amendments to change CBI reporting such that the Agency expects a decrease in the number of CBI claims, thereby enabling EPA to provide a greater amount of the information to these various stakeholders. In addition, EPA will provide analyses of the amended IUR information and anticipates that other organizations will use the results. Through efforts made by these various stakeholders, the data to be collected under the proposed IUR amendments could reduce risks and costs to society in addition to the reductions gained by the programs conducted by OPPT.

a. Other Federal Risk Management Programs Federal efforts other than OPPT's would benefit from new exposure information for IUR chemicals. For example, OSHA currently manages occupational exposure to chemicals by setting a variety of chemical and personal protection standards, by requiring preparation of emergency response and process safety management plans, and by requiring provision of health and safety data to workers for chemicals used in the workplace. OSHA would be able to use the amended IUR data to identify chemicals with large numbers of potentially exposed workers or with uses that suggest greater exposure potential. The amended IUR information could increase OSHA's ability to manage chemical hazards, exposures, and risks in occupational settings.

NIOSH would also benefit from the updated exposure related information collected under the IUR amendments. Currently, the exposure information that NIOSH uses to determine occupational safety and health in businesses nationwide is primarily based on outdated information collected under the National Occupational Exposure Survey ( NOES). Completed in 1983, NOES collected information such as plant site location, plant site SIC, information on the plant site's occupational safety and health programs, occupational titles of workers potentially exposed, the number of employees per occupational title, information on process steps, and trade names of products. Amended IUR data could be used by NIOSH in place of the NOES data to identify chemicals with large numbers of potentially exposed workers or with uses that suggest greater exposure potential.

CPSC also could directly use the proposed data in conducting its exposure and risk assessment activities  screening consumer products for chemical hazards. The primary risk information used by CPSC to screen chemical hazards is information obtained from a network of hospital emergency rooms,

and this is limited to injuries and illnesses resulting from acute exposures only. Information identifying V 26 the chemicals used in consumer products is not readily available to CPSC at this time. The IUR amendments would provide a source of reliable information on the chemicals used in consumer products, enabling CPSC to identify the chemicals used in consumer products and, with consideration of hazard data, to identify chemical consumer use situations presenting greater potential risk. The information could improve CPSC's ability to meet its program objective of protecting the public from chemical hazards in consumer products.

b. State and Local Programs The proposed IUR amendments data would also help state and local authorities with rulemaking, information collection, and voluntary program activities. Because state and local governments must address chemicals, use patterns, and exposure scenarios that may be unique or isolated, state and local agency access to the enhanced data would assist in identifying situations that pose potentially high risks for individual states or locations within those states. The information added to the IUR includes county data, which would enable states to identify which counties are likely to have specific issues or which counties may have multiple chemical problems. The additional data also could be used to assist with setting goals, targeting actions, and developing or expanding pollution prevention activities. Several state environmental protection agencies, including those in Illinois, Georgia,

California, and New Jersey, have expressed interest in having access to data collected by OPPT and to results of risk screening conducted by OPPT.

c. Non Governmental Organization ( NGO) Initiatives and Private Sector Stewardship Many private sector organizations proactively reduce risks and provide leadership in preventing pollution while still maintaining productive economic enterprises. These organizations can improve their programs by developing a better understanding of how chemicals are used in general, thus encouraging more effective participation in community, regional, and national priority setting for chemicals. Activities typically undertaken by NGOs involve tracking industry trends,

organizing grassroots involvement in risk based decision making, and conducting outreach and educational programs. The proposed data could be used by these organizations to identify and establish priorities for risks, to evaluate chemicals and chemical use patterns to determine areas of concern, to V 27 identify and promote pollution prevention opportunities, and to focus pollution prevention, public outreach, and education initiatives and activities.

Industry can use the amended IUR information to improve corporate product stewardship programs through access to use information reported by multiple companies. The Chemical Manufacturers Association's ( CMA) Responsible Care Program is one example of a corporate product stewardship program that could use this information. Currently, the CMA cites " emission reductions as measured by TRI" and a growth in the number of Community Advisory Panels as strengths in its Responsible Care Program. Use information supplied through an amended IUR could be used to further strengthen this program. The Responsible Care Program requires companies to take responsibility for their products from cradle to grave, which requires an understanding of how their product is being used not only by their customers, but further down the chain. Despite this private effort, companies have told EPA that they don't know how their chemicals are used. Information provided by multiple companies could give an individual company a better understanding of the downstream uses of their product,

therefore enabling more effective implementation of the Responsible Care concepts.

B. Benefits Due to Fewer CBI Claims A second category of benefits attributable to the proposed IUR amendments stems from changes in the requirements for claiming information as CBI; these changes are expected to enhance the utility of the data and the public's access to that data. Three basic changes are proposed. First, EPA is proposing to add a requirement to provide up front substantiation for facility identification, as well as the original requirement for up front substantiation for chemical identity. EPA has found that CBI claims have been made for facility identification when that information has already been made public through the reporting requirements under EPCRA and other public documents.

Second, under the proposal, submitters could claim a non CBI status for production volume information in ranges while continuing to claim specific production volume as CBI. This change is expected to reduce claims because although some submitters may continue to claim production volume information in ranges as CBI, it is expected that other submitters will not feel the need to claim this information as confidential. Third, a reassertion of previous CBI claims is proposed. The EPA believes that information that is four years old or more would typically have lost its proprietary value and would V 28 not need to be maintained as CBI. This change provides a mechanism to ensure that older CBI claims would be reviewed by the submitter; companies would have to restate a claim or else confidentiality would lapse. EPA expects this change to decrease the amount of information that would have to remain under CBI protection.

The Agency expects these changes to reduce the number of CBI claims, increasing the amount of information available to the public. This has several benefits. The Agency's would be able to more publicly support its actions and decisions. Currently, support for Agency decisions is often CBI and cannot therefore be included in any publicly available support document. The public will be better informed and better able to provide comment on Agency actions. Second, the Agency will be able to provide the public with information to make its own decisions. These benefits were discussed in more detail in earlier sections of this chapter and center around the fact that increasing the amount of information available for the public allows for improved understanding of potential exposure and risk concerns.

C. Benefits of Changing Certain Exemptions A third category of expected benefits of the IUR amendments relates to proposed changes to the exemptions under the original IUR. One major change is the elimination of the inorganic chemical exemption, which was originally developed based on EPA's belief that the hazard potential of many inorganic chemicals was relatively well established and therefore production information was not needed. Recent findings with lead and other inorganic chemicals have brought EPA to the conclusion that hazard information alone is not enough to protect human health and the environment  use,

exposure, and volume information for inorganic chemicals is also needed. Collecting information on inorganic chemicals through the proposed amended IUR would provide EPA with better knowledge of the chemicals being manufactured, what their production characteristics are, and the extent of potential exposures. As a result, the addition of this information on inorganic chemicals will enable the Agency to consider exposure to inorganic chemicals when evaluating risk potential. This information would improve OPPT's ability to conduct risk screens and develop management activities for those chemicals.

EPA will be able to make decisions about this class of chemicals that heretofore have been difficult or, in some cases, not possible. V 29 The Agency has considered an option of continuing the exemption for inorganic chemicals. This option, referred to as Option 11 in Chapter III, would limit EPA's ability to effectively screen risks for all potentially hazardous or risky inorganic chemicals. As discussed above, by eliminating the inorganic chemical exemption under the proposed option EPA will gain access to additional production volume and exposure related data that could potentially aid in risk management and prescreening of inorganic chemicals. Option 11 would result in use and exposure information in approximately 12,155 reports on approximately 5,240 discrete chemicals, while the proposed option would result in approximately 15,400 reports for approximately 6,000 discrete chemicals.

The second major change in exemptions is the addition of a partial reporting exemption for petroleum stream chemicals. This exemption is being proposed because petroleum streams tend to be complex chemical mixtures with variable constituents. As such, these chemicals tend to be of low priority for EPA risk assessments. These factors have led the Agency to the decision that the collection of this information is not a priority at this time.

The Agency has also considered an option of exempting only site limited petroleum streams from reporting under the IUR amendments. This option, referred to as Option 10 in Chapter III, would reduce the information EPA would be collecting by eliminating information for site limited petroleum stream chemicals. The Agency settled on the broader proposed option, which exempts reporting of use and exposure information for multi chemical petroleum process streams, as discussed in the previous paragraph. The proposed option would exempt about 140 more discrete chemicals from reporting use and exposure information than the site limited petroleum stream exemption. The site limited petroleum stream exemption would result in use and exposure information in approximately 19,800 reports on approximately 6,200 discrete chemicals, while the proposed option would result in approximately 15,400 reports for approximately 6,000 discrete chemicals.

D. Administrative and Related Benefits The fourth category of benefits from the proposed IUR amendments stems from changes to several administrative requirements, each of which will facilitate data exchange and increase data comprehensiveness. Overall, the administrative changes would enhance the utility of the data by allowing linkages between various Agency databases. In addition, these changes would change the V 30 reporting time frame to make IUR reporting more consistent within itself and with other EPA reporting requirements.

Specific benefits attributable to administrative changes under the IUR amendments flow from several sources. One of the proposed IUR amendments would require submission of EPA facility identity ( EPA ID) numbers and the county in which the facility is located. These data would increase consistency with the identification systems of other EPA information collection efforts and is one step in the direction of " one stop reporting," an existing Agency initiative under development. Consistent facility identification information reported across the Agency would help to link data, providing both an important analysis tool and an important enforcement tool. State and other potential users of the data will also be able to examine the chemicals produced in a specific locality such as a county.

In addition, changing the reporting time frame from fiscal year to calendar year for all reporting sites would make the information collected more amenable to use as the information covers the same time frame. Another benefit to this comes from the improved ability to combine IUR information with information from other data sources using calendar reporting. For instance, a calendar year reporting cycle would correspond with the TRI reporting period, enhancing the Agency's ability to develop linkages between the two databases. With all information provided covering the same time frame, more accurate assessments of the status of the industry would be possible. For those submitters already reporting information on a calendar year basis for other collections, this change may result in greater efficiency of company information collection and recordkeeping.

E. Benefits From Reporting Thresholds From the perspective of benefits, the most significant elements of the proposed option are ( 1)

the addition of exposure information to the reporting requirements and ( 2) the adjustment to reporting thresholds for facility and manufacturing information and for exposure and use information. The addition of exposure related information has been discussed in Section A. 1. Benefits resulting from the threshold options are discussed below. It should be noted that because the actual risk reductions that will occur as a result of this proposed rule have not been quantified, a qualitative argument is developed to illustrate the paths of risk reduction and the extent to which reduced mortality and morbidity might result.

There are two reporting thresholds proposed in these amendments  a reporting threshold for facility and manufacturing information ( e. g., facility location and information associated with producing V 31 the chemical) and a reporting threshold for use and exposure data ( e. g., numbers of exposed employees at use sites, number of use sites, percent of production volume). Reporting threshold options considered by EPA are presented in Table V 4. Of the options presented, Option 4 is the option proposed for the IUR amendments and sets the annual production threshold at 25,000 pounds for facility and manufacturing data and 100,000 pounds for use and exposure information. The original IUR requirements have a reporting threshold of 10,000 pounds. With the exception of the first option, all of the options increase the threshold for use and exposure information from this baseline threshold, while either maintaining the baseline or increasing to the proposed threshold level for the facility and manufacturing information.

The choice of threshold level is very important. The amount of information, and therefore the benefits, vary greatly depending upon the number of chemicals for which reports are submitted. The more reports, the more information EPA and others have for input into their decisions. However, there is a cost associated with the submission of this information. In considering the threshold levels, EPA balanced information needs and associated benefits with the cost of the information. EPA has determined that the threshold levels proposed provide the level of data necessary to provide EPA with the information necessary to screen the thousands of larger volume chemicals, develop risk management initiatives, and track changes in the marketplace ( and therefore in exposure scenarios)

while not unduly burdening industry.

To estimate changes in the amount of information provided under each of the reporting threshold options, historical IUR data regarding the number of report submissions was sorted by production volume. The remainder of this section discusses the effect that the proposed reporting thresholds and the other options considered would have on the benefits associated with use of the data collected though the proposed amended IUR.

1. Reporting Threshold Options for Facility and Manufacturing Information As shown in Table V 4, the two reporting threshold options considered for submission of facility and manufacturing information are 10,000 and 25,000 pounds. The original reporting threshold requirement is 10,000 pounds; the IUR amendments propose to raise the reporting threshold to 25,000 pounds. This increase in the reporting threshold has been proposed to help reduce societal costs V 32 resulting from the proposed IUR amendments, as discussed in Chapter III. Possible impacts on the generation of societal benefits posed by these two options are briefly discussed below.

Table V 2. Reporting Threshold Options for the Proposed IUR Amendments Option # Facility Identification and Manufacturing Information Processing and Use Information 1 10,000 lb 10,000 lb 2 25,000 lb 25,000 lb 3 10,000 lb 100,000 lb 4 25,000 lb 100,000 lb 5 10,000 lb 500,000 lb 6 25,000 lb 500,000 lb 7 25,000 lb 1,000,000 lb 8 25,000 lb 10,000,000 lb 9 25,000 lb 500,000 lb/ 100,000 lb a. 10,000 Pound Threshold for Facility and Manufacturing Data This threshold option is equivalent to the original reporting threshold for submission of facility and manufacturing data. Taking into account the changes in exemptions included in the proposed IUR amendments ( addition of inorganic chemicals), information on approximately 10,400 chemicals would be reported. Benefits associated with the addition of inorganic chemicals and with the addition of the new information requirements was discussed previously. As this threshold is the same as the baseline level, there are no changes to the benefits due to the level. However, this option does maximize the amount of useful facility and manufacturing information collected by EPA. In particular,

data for chemicals with low production volumes would be more readily available for use in risk prescreening and in conducting other activities, such as use and substitutes analyses. Without access to this level of facility and manufacturing data, data on production of chemicals with low production volumes would no longer be available to OPPT risk managers.

b. 25,000 Pound Threshold for Facility and Manufacturing Data V 33 The reporting threshold for the facility and manufacturing data proposed in the IUR amendments is 25,000 pounds. It is estimated that by increasing the reporting threshold to 25,000 pounds, information on approximately 8,900 discrete chemicals would be collected. This is 15 percent fewer chemicals than those estimated to be reported for the 10,000 pound threshold under Option 1.

With this change, benefits would decrease because EPA risk managers would no longer have access to current data on small volume chemicals ( i. e., those produced between 10,000 and 25,000 pounds). This loss of data would potentially affect EPA's ability to undertake risk pre screening activities, as well as the preparation of certain important analyses, including use, substitutes, and use cluster analyses. Without the data on these chemicals, information that would help to reduce exposure risks for chemicals may no longer be readily available to OPPT. It is expected, however, that reductions in societal benefits associated with a change from 10,000 pounds to 25,000 pounds for facility and manufacturing data would not be significant compared to those associated with changes in thresholds for use and exposure data, as described below.

EPA chose this threshold level in order to reduce the burden on submitters. EPA acknowledges that information on the lower volume chemicals would be useful and may find it necessary to collect this information in the future.

2. Reporting Threshold Options for Use and Exposure Information EPA considered reporting thresholds for the submission of use and exposure data by ranging from 10,000 to 10,000,000 pounds, as presented in Table V 4. Because submission of use and exposure data is not required under the original IUR, all of the reporting threshold options considered would result in a more complete data set. However, each reporting threshold option considered during the development of amendments makes available to the OPPT significantly different levels of use and exposure data. Again, EPA balanced data needs and associated benefits with the cost of information submission. EPA determined that a threshold of 100,000 pounds best balances the needs of EPA, the public, and industry at this time. The overall extent and magnitude of the effects on societal benefits for each of the reporting options considered is discussed below.

a. 10,000 Pound Threshold for Use and Exposure Data V 34 The lowest reporting threshold option considered for requiring submission of use and exposure information is 10,000 pounds. This option would serve to maximize the amount of use and exposure data collected. Use and exposure information on approximately 10,000 discrete chemicals would be reported. Greater benefits would be generated at this threshold than under the higher threshold options because there would be more comprehensive data on small volume chemicals. EPA historically has believed that, in general, a larger production volume indicates a more likely risk concern. However,

the information on lower volume chemicals often provides data on substitutes for larger production chemicals. In addition, information on the lower volume chemicals is most unlikely to be publicly available; it is often the case that, for lower volume chemicals, little to no mention of them is made in the published literature. This situation limits EPA's ability to identify the lower volume chemicals and makes any analyses of those chemicals highly improbable. This lack of information also reduces the effectiveness of analyses of larger volume chemicals as the likelihood of substitute information could be either eliminated or greatly diminished.

b. 25,000 Pound Threshold for Use and Exposure Data With the exception of Option 1, this option would result in the greatest number of submissions containing use and exposure information. It is estimated that this option would result in the collection of use and exposure information on approximately 8,500 discrete chemicals. As is the case for the 10,000 pound threshold described above, collection of valuable use and exposure data for low volume chemicals, albeit somewhat less than under the 10,000 pound threshold, would be possible under this production volume threshold. Benefits derived from this threshold, as compared to the proposed option, are similar to those discussed under the 10,000 pound option.

c. 100,000 Pound Threshold for Use and Exposure Data This is the proposed option for the IUR amendments for reporting requirements for use and exposure information. This option will result in a level of submissions that will provide an effective level of coverage. EPA estimates that this option will result in the collection of use and exposure information on approximately 6,000 discrete chemicals.

EPA has determined that this is the optimum level of information. Collection of this level of data would provide valuable input to OPPT risk screening activities, streamlining EPA's efforts to correctly V 35 identify chemicals needing further review and subsequently improving later risk management efforts.

This level of coverage also allows EPA to track changes in chemical use over time, enabling EPA to react to the dynamic environment of the chemical industry.

d. 500,000, 1,000,000, and 10,000,000 Pound Reporting Threshold Options The 500,000, 1,000,000, and 10,000,000 pound reporting threshold options would all significantly reduce the benefits resulting from use and exposure data for chemicals reported under the IUR. Compared to the 100,000 pound reporting threshold, these options would reduce the number of submissions containing use and exposure information by between 35 and 72 percent. Use and exposure information would be collected on fewer chemicals, ranging from a decrease of approximately 2,400 chemicals at the 500,000 pound threshold to a decrease of approximately 4,900 chemicals at the 10 million pound threshold. As the reporting threshold increases, the information available for EPA decision makers would become increasingly limited and would generate proportionately fewer benefits. EPA's efforts to protect human health and the environment would be restricted to those chemicals with very large production volumes. Hence, under these higher threshold options, EPA's ability to effectively screen risks for a large number of potentially risky chemicals would be impeded by a lack of information.

F. Benefits From Reporting Cycle Options The baseline reporting cycle is being retained for this proposal. Reporting currently is required every four years. EPA considered three alternatives to this cycle. The first alternative, referred to as Option 12 in Chapter III, would require all reportable chemicals to report facility and manufacturing information every two years and use and exposure information every four years. This would allow EPA to collect manufacturing information for chemicals that are produced periodically, and hence, may not be captured in a four year reporting cycle. EPA would also be collecting information that would more closely track the changing chemical industry. The second alternative, referred to as Option 13 in Chapter III, would require all information to be reported every two years. Past experience with reporting shows the dynamic nature of the chemical industry ( about 30% of the chemicals reporting in 1990 were not reported in 1994), providing justification for collecting information on a more frequent basis.

However, EPA also felt that the information would not be put to sufficient use to justify the additional V 36 expense to industry to supply this information. The third alternative, Option 14, would require one time reporting. While this option reduces costs significantly, it does not allow EPA to develop a stream of information over time to assess risks on an ongoing basis and it would quickly become out of date. VI 1 CHAPTER VI. COST BENEFIT ANALYSIS AND COST EFFECTIVENESS COMPARISONS Cost benefit analysis is performed for proposed rules in order to ensure that the social benefits of a regulation outweigh the costs imposed on the regulated community and EPA, and to select the proposed regulatory option that offers the highest cost benefit reward. For the proposed IUR amendments, however, a quantitative cost benefit analysis is far from straightforward. This is because many of the benefits, as described in Chapter V of this report, have to do with information collection rather than the direct avoidance of harm.

As a result, EPA has used a cost effectiveness criterion to compare options. This approach,

described in more detail below, looks at the amount of data collected and its cost, without quantifying the benefit of each option. The new information proposed to be collected under the IUR amendments would assist the Agency in developing chemical screening priorities, streamlining regulatory efforts, and making informed risk assessment and management decisions. This information would improve EPA's understanding of potential exposures resulting from industrial chemical use, allow EPA to more accurately track chemical use and exposure, and permit EPA to more effectively target chemicals that pose the greatest hazard or risk. In the case of the IUR amendments, lowering the costs to society while maximizing and targeting the information collected leads to cost effective regulation.

The value of the information alone cannot be determined, especially given that the exposure and use information has yet to be collected. Thus, in contrast to many RIAs, the benefits of this regulation cannot be directly expressed in terms of avoided harm or other conventional measures. Nevertheless,

the incremental costs of the proposed IUR amendments are justified by the potential longer term savings for industry reporting and EPA adminstration, and the higher cost benefit performance of future regulation.

In order to evaluate potential options for the IUR amendments, EPA has used a measure of cost effectiveness rather than a cost benefit analysis. Cost effectiveness is a measure of the efficiency of a regulatory option in achieving a level of benefits. It is generally calculated by dividing the costs of a 36 Some chemicals are partially exempt, in that manufacturers need only submit partial reports regardless of the production volume. This explains why Options 1 and 2, which have the same level for both thresholds, still have some partial reports being submitted.

VI 2 regulatory option by the benefits. For this analysis, therefore, cost effectiveness is described in terms of the relative amount of IUR data collected and the cost of collecting those data.

The remainder of this section presents the proposed option, and then describes and discusses each of the other options compared to the proposed option. As discussed in Chapter 2, the regulatory options vary along several parameters. The most important parameters are the two chemical production thresholds, which determine when producers must report only facility and manufacturing data (" partial form") and when they must report use and exposure data (" full form"). 36 Other parameters include the length of the reporting cycle, and additional exemptions from reporting for various classes of chemicals.

Table VI 1 presents an analysis of the amount of information that will be collected and Table VI 2 presents the first year cost of each option relative to the proposed option. VI 3 Table VI 1. Comparison of Information Collected Under Each Regulatory Option Option Number of Reports Partial Form Percent of Proposed Option Full Form Percent of Proposed Option Total Percent of Proposed Option Option 1 5,833 51 24,765 160 30,598 114 Option 2 5,733 50 21,078 136 26,811 100 Option 3 15,167 133 15,431 100 30,598 114 Option 4 11,380 100 15,431 100 26,811 100 Option 5 20,511 180 10,087 65 30,598 114 Option 6 16,724 147 10,087 65 26,811 100 Option 7 18,393 162 8,418 54 26,811 100 Option 8 22,435 197 4,376 28 26,811 100 Option 9 16,724 147 10,087 65 26,811 100 11,380 100 15,431 100 Option 10 5,763 51 19,814 128 25,577 95 Option 11 10,154 89 12,155 79 22,309 83 Option 12 11,380 100 15,431 100 26,811 100 Option 13 11,380 100 15,431 100 26,811 100 Option 14 11,380 100 15,431 100 26,811 100 The proposed option for the IUR amendments, Option 4, would require subject chemicals to be reported if they are produced in quantities greater than an annual production volume of 25,000 pounds.

For those chemicals produced at a production volume greater than or equal to 25,000 pounds but less than 100,000 pounds, only the partial form ( facility identification and manufacturing information) would be required. With the exception of partially exempt chemicals, for chemicals produced at a production volume greater than or equal to 100,000 pounds, the reporter would be required to submit the full form,

providing use and exposure information in addition to the facility identification and manufacturing information. This option would result in the submission of 26,811 reports. Fifty eight percent of the reports ( 15,431) would include both IUR and IUR amendment information. The incremental first year cost of the proposed option relative to the original IUR is expected to range from $ 47.9 million to $ 65.4 million. VI 4 Option 4 is among the most cost effective options considered. That is, it has low incremental costs for the number of full and partial forms that would be submitted. Option 4 has two other advantages relative to other similarly cost effective options. First, its lower threshold ( i. e., the level at which a partial form is required) is 25,000 lbs and not 10,000 lbs. In the experience of EPA, for TSCA reporting and other programs, the data gathered for low production volume chemicals between roughly 10,000 and 25,000 pounds tends to be less valuable than that for larger production chemicals. This is because low production chemicals tend to have specialty applications that limit the amount of exposure.

Second, Option 4 collects full information for chemicals in excess of 100,000 lbs of production.

Chemicals below this level tend to be less of a priority for risk management, so a higher upper threshold can reduce the cost ( relative to an upper threshold lower than 100,000) without losing much high priority data for risk management purposes. In addition to being highly cost  effective, therefore, Option 4 is likely to yield important benefits that will make the IUR amendments more effective.

Option 1 would require full forms for all subject chemicals if they are produced over an annual production volume of 10,000 pounds. This option would result in the submission of 24,765 full reports, as well as 5,833 partial reports for the partially exempt chemicals. This yields a total of 30,598 reports ( 1.14 times as many as the proposed option) for an incremental first year cost to society of between $ 69.2 million and $ 91.2 million, or between 39 and 44 percent more expensive than the proposed option.

This option is similarly cost effective to Option 4. Although more expensive than the proposed option, it collects more data overall and considerably more exposure and use data ( full forms) on small VI 5 Table VI 2. Comparison of Incremental First Year Industry Costs Under Each Regulatory Option Options Incremental First Year Industry Costs Low High Incremental First Year Cost ($ M) Percent of Proposed Option Incremental First Year Cost ($ M) Percent of Proposed Option Option 1 $ 69.2 144 $ 91.2 139 Option 2 $ 58.3 122 $ 76.6 117 Option 3 $ 52.1 109 $ 72.7 111 Option 4 $ 47.9 100 $ 65.4 100 Option 5 $ 42.3 88 $ 62.0 95 Option 6 $ 38.1 80 $ 54.8 84 Option 7 $ 35.1 73 $ 51.4 78 Option 8 $ 27.7 58 $ 43.4 66 Option 9 $ 38.1 80 $ 54.8 84 Option 10 $ 54.4 114 $ 71.5 109 Option 11 $ 36.8 77 $ 50.4 77 Option 12 $ 47.9 100 $ 65.4 100 Option 13 $ 47.9 100 $ 65.4 100 Option 14 $ 47.9 100 $ 65.4 100 volume chemicals. Prior experience leads EPA to believe that full information for small volume chemicals is not as important as for large volume chemicals, making Option 1 less preferable to Option 4.

Option 2 is similar to Option 1, but with a higher threshold level. Full reports are required for subject chemicals if they are produced over an annual production volume of 25,000 pounds. Partial reports are also required for partially exempt chemicals. This option would require the submission of 26,811 reports, the same as for the recommended option, but with 36 percent more full reports providing exposure and use information. This increase in total data collected is offset by 17 to 22 percent higher costs; incremental first year costs for Option 2 are expected to range from about $ 58.3 million to $ 76.6 million. Option 4 is preferred over Option 2 because it focuses reporting on higher priority chemicals produced at levels over 100,000 pounds. VI 6 Option 3 would require subject chemicals to be reported if they are produced over an annual production volume of 10,000 pounds. For those chemicals produced at a production volume greater than or equal to 10,000 pounds but less than 100,000 pounds, only facility and manufacturing information would be required. For chemicals produced at a production volume greater than or equal to 100,000 pounds, the reporter would be required to provide use and exposure information, as well as facility and manufacturing information. This option would result in the submission of the same amount of use and exposure data, but would generate significant information on production of chemicals produced between 10,000 pounds and 25,000 pounds for an incremental cost of approximately $ 52.1 million to $ 72.7 million, only 9 to 11 percent higher than the proposed option. This option is less cost effective than Option 4 and collects data for very low production chemicals that are not seen as a high priority.

Option 5 would require subject chemicals to be reported if they are produced over an annual production volume of 10,000 pounds. For those chemicals produced at a production volume greater than or equal to 10,000 pounds but less than 500,000 pounds, only facility and manufacturing information would be required. For chemicals produced at a production volume greater than or equal to 500,000 pounds, the reporter would be required to provide use and exposure information as well as facility and manufacturing information. This option would result in submission of 10,087 reports containing use and exposure information, or about 65 percent of the amount that would be collected under the proposed option. This option has an incremental cost of about $ 42.3 million to $ 62.0 million, or 88 percent to 95 percent of the proposed option. Although this option collects facility and manufacturing information on small volume chemicals ( i. e., those produced between 10,000 lbs and 25,000 lbs.), it is less cost effective than the proposed option because it reduces the amount of use and exposure information collected by about 35 percent while only reducing costs by about 5 to 12 percent.

Option 6 would require subject chemicals to be reported if they are produced over an annual production volume of 25,000 pounds. For those chemicals produced at a production volume greater than or equal to 25,000 pounds, but less than 500,000 pounds, only facility and manufacturing information would be required. For chemicals produced at a production volume greater than or equal to 500,000 pounds, the reporter would be required to provide use and exposure information, as well as facility and manufacturing information. This option is similar to Option 5 except that it would not require VI 7 facility and manufacturing information to be collected on chemicals produced in quantities less than 25,000 pounds. Although it is more cost effective than Option 5 in that incremental first year costs are expected to be about 80 to 84 percent as much as the proposed option, it less cost effective than the proposed option. Approximately 65 percent of the use and exposure information would be collected under this option, compared to the proposed option.

Option 7 would require subject chemicals to be reported if they are produced over an annual production volume of 25,000 pounds. For those chemicals produced at a production volume greater than or equal to 25,000 pounds, but less than 1 million pounds, only facility and manufacturing information would be required. For chemicals produced at a production volume greater than or equal to 1 million pounds, the reporter would be required to provide both use and exposure information as well as facility and manufacturing information. In comparison to the proposal, this option collects about 54 percent of the use and exposure data at an incremental first year cost of about 73 to 78 percent of the proposed option. This option is less cost effective and significantly reduces the amount of use and exposure information that would be collected on an important class of chemicals ( i. e., those chemicals produced in volumes up to 1 million pounds). By not having access to data for these chemicals, the Agency's ability to perform screening assessments and other risk management activities would be seriously impaired.

Option 8 would require subject chemicals to be reported if they are produced over an annual production volume of 25,000 pounds. For those chemicals produced at a production volume greater than or equal to 25,000 pounds but less than 10 million pounds, only facility and manufacturing information would be required. For chemicals produced at a production volume greater than or equal to 10 million pounds, the reporter would be required to provide use and exposure information as well as facility and manufacturing information. This option collects only about 28 percent of the use and exposure data compared to the proposed option. The incremental first year cost of this option ranges from $ 27.7 million to $ 43.4 million, or about 58 to 66 percent of the costs of the proposed option.

Because only chemicals produced at levels above 10 million pounds would have use and exposure data reported, this option provides only marginally useful data and is not considered cost effective. The amount of data in the general literature on chemicals produced in volumes above 10 million pounds VI 8 tends to be greater than for small volume chemicals and the Agency would be able to discover much of the information for these large volume chemicals through other means. While the level of information would not be as comprehensive as that which would be collected under the IUR amendments, collecting this information for such a small subset of chemicals is not cost effective.

Option 9 would require subject chemicals to report if they are produced over a threshold volume of 25,000 pounds. This option incorporates characteristics of Option 6 and the proposed option. In the first reporting period, only chemicals produced over a threshold volume of 500,000 pounds would be required to report use and exposure information. For the second reporting period, the reporting threshold for use and exposure information would be reduced to 100,000 pounds. This option would result in estimated incremental first year costs of between $ 38.1 million and $ 54.8 million, or 80 percent to 84 percent of the proposed option.

Option 10 would require the same threshold volumes and reporting cycles as the proposed option, but would provide different chemical reporting exemptions. Under this option, site limited petroleum streams would be exempt from reporting any information and the petroleum stream exemption outlined in the proposed option would not apply. Option 10 would increase the incremental first year cost by approximately 9 to 14 percent compared to the proposed option and would collect 28 percent more exposure and use information than the proposed option. However, EPA feels the information on the petroleum stream chemicals would only be marginally useful at this time and concludes that collecting this information would not be cost effective.

Option 11 would require the same threshold volumes and reporting cycles as the proposed option, but would provide different chemical reporting exemptions. Under this option, inorganic chemicals would be exempt from reporting any information. Option 11 would reduce the incremental first year cost by approximately 23 percent compared to the proposed option and would collect 21 percent less use and exposure information than the proposed option. However, EPA feels that information on inorganic chemicals would be extremely useful and concludes that collecting this information is cost effective.

Options 12, 13, and 14 would require subject chemicals to be reported over the same threshold volumes as the proposed option, but over different reporting cycles. Option 12 would require that facility VI 9 and manufacturing information be collected every 2 years and use and exposure data every 4 years.

Option 13 would require that all information be collected every two years. Option 14 would require one time reporting of all information. These options do not impact first year costs or the amount of information that is collected relative the proposed option, but the more frequent reporting increases costs incurred in future years. Option 12 increases incremental net present value costs by about 46 to 58 percent, while Option 13 increases incremental net present value costs by about 92 percent to 96 percent. One time reporting under Option 14 would reduce net present value and annualized costs significantly, to about 25 percent of the proposed option. 37 Because the intent of the proposed amendments is to collect information from manufacturers and importers only, there would be no impact on small businesses that only process or distribute chemicals or products, but do not manufacture or import the chemicals.

VII 1 CHAPTER VII. SMALL ENTITY AND ENVIRONMENTAL JUSTICE IMPACT DETERMINATIONS This chapter presents the estimated impacts of the IUR amendments on small entities and presents a discussion of environmental equity and justice concerns.

The Regulatory Flexibility Act of 1980 requires Federal Agencies to assess the effects of proposed regulations on small entities ( P. L. 96 354). The Act requires agencies to evaluate all proposed rulemakings to determine if an Initial Regulatory Flexibility Analysis ( IRFA) is necessary. If the regulation will result in significant impacts on a substantial number of small entities, the Agency must examine alternatives that may reduce adverse economic effects on significantly impacted entities. The Regulatory Flexibility Act was Amended by the Small Business Regulatory Enforcement Fairness Act of 1996. Section A of this chapter contains an examination of the effect of these proposed amendments on small entities, and Section B presents an analysis determining that an IRFA is not necessary.

Executive Order 12898, Federal Actions to Address Environmental Justice in Minority Populations and Low Income Populations, requires that each Federal agency examine the effect of its regulations on minority and low income populations, and address disproportionately high and adverse human health or environmental effects. Section C below contains an examination of the effect of these proposed amendments on minority and low income populations.

A. Small Entity Analysis The term " small entities" includes small businesses, small not for profit organizations, and small governmental jurisdictions, but since not for profit organizations and governmental jurisdictions will not be affected by this proposed rule, " small entity" in this analysis is synonymous with small business. For the proposed IUR amendments, small businesses are limited to small chemical manufactures and importers. 37 Section 605( b) of the Regulatory Flexibility Act requires the Agency to either certify that the regulatory action will not have a significant economic impact on a substantial number of small entities or 38 It is important to note that the $ 40 million level is for parent company sales, not individual site sales.

VII 2 prepare an Initial Regulatory Flexibility Analysis ( IRFA). The basis for the determination that there is no significant economic impact is provided in the sections below.

1. Determination of the Number of Small Businesses The following sections present ( 1) the definition of small businesses under the requirements of the original IUR and the proposed IUR amendments, ( 2) the definition of small businesses that is used for the purposes of this report, and ( 3) the methodology for determining the number of small businesses expected to report under the IUR amendments.

a. Definition of Small Business The definition of small businesses under TSCA § 8( a) includes those firms whose annual sales are less than or equal to $ 40 million and produce less than 100,000 pounds of a regulated substance at a single manufacturing site ( the original IUR exempts small businesses that manufacture less than 100,000 pounds of a chemical in a reporting year from all reporting; this exemption will remain unchanged under the proposed IUR amendments). Firms that generate $ 4 million or less in annual sales are considered small businesses regardless of production volume ( 40 CFR 704.3). For purposes of this analysis, it is assumed that any firm with sales less than or equal to $ 40 million is small, regardless of production volume. 38 This assumption may tend to overestimate the number of small businesses affected because it includes entities that may not meet all small business requirements under TSCA § 8( a).

b. Number of Small Businesses The expected number of small businesses reporting under the proposed IUR amendments was estimated according to the following methodology. First, the expected number of businesses producing organic chemicals that would be required to report was estimated based on information in the CUS Database for the 1994 reporting cycle. Second, the expected number of businesses producing inorganic chemicals that would be required to report was estimated. Because the CUS contains no data for inorganic chemicals, the number of businesses producing inorganic chemicals that are expected to report was estimated based on the relationship between the number of organic VII 3 chemicals and inorganic chemicals identified in the CICIS Database ( 1986) maintained by EPA.

Together, these two estimates represent the number of small businesses affected.

i. Organic Chemicals Businesses To determine the number of small businesses producing organic chemicals that may be affected by the proposed rule, annual sales information was sought for the 758 companies that submitted production volume and company identification information for the IUR in 1994 ( CUS Database 1996, CUS Database 1997). Of these companies, information on parent company annual sales was obtained for 627 companies from the Thomas Register ( 1990), Dun and Bradstreet ( D& B 1996, D& B 1992), and Ward's Business Directory ( 1996). Annual sales data were unavailable for the remaining 131 companies.

There are several possible explanations for the unavailability of information for these remaining companies. First, these businesses may be too small to be listed in the directories that were consulted.

Second, the IUR database may be out of date because it is based on TSCA reporting for 1994 ( e. g., some companies may have gone out of business or changed hands since the information was reported). Finally, certain companies may have requested to be " delisted" or may have declined to provide information to the various directories.

Because the missing company information could not be obtained, these companies have been allocated to the small, medium, and large size categories according to two methodologies. In the first approach, each of the remaining 131 companies has been distributed according to the relative distribution established for the 627 companies for which data were available. The second approach placed all 131 companies in the small business category based on the assumption that these companies were too small to be listed. Table VII 1 presents company size information for the estimated 758 parent companies that submitted IUR information in 1994. The table identifies the proportion of small, medium,

and large companies, as defined by annual sales, that are likely to be affected by the proposed rule. As the table indicates, a range of between 21 percent and 35 percent of the regulated community may be considered to be small ( i. e., annual parent company sales less than or equal to $ 40 million). VII 4 Table VII 1. Size of Manufacturing Companies Producing Organic Chemicals Based on Annual Sales Information Company Size Based on Annual Salesa Basisb Method 1: Allocated by Proportionsc Method 2: Allocated as Small Businessesd Companies Companies Companies Number Percent Number Percent Number Percent Small ( annual sales less than or equal to $ 40 million) 132 21 159 21 264 35 Medium ( annual sales greater than $ 40 million and less than or equal to $ 200 million) 133 21 159 21 133 18 Large ( annual sales greater than $ 200 million) 362 58 440 58 362 48 Total 627 100 758 100 758 100 a Annual sales are for the parent company, when applicable. b The actual breakdown by size of the 627 companies that reported for the IUR in 1994 for which company sales data were available. c The estimated breakdown by size of all 758 companies that reported for the IUR in 1994 if the sizes of the 131 companies for which sales data were unavailable are assumed to be in the same proportion as the sizes of the companies for which sales data were available. d The estimated breakdown by size of all 758 companies that reported for the IUR in 1994 if all of the 131 companies for which sales data were unavailable are assumed to be small businesses.

Sources: Ward's Business Directory 1996, D& B 1996, D& B 1992, Thomas Register 1990, CUS Database 1996, CUS Database 1997.

ii. Inorganic Chemicals Businesses EPA next accounted for businesses that will submit inorganic chemical reports under the IUR amendments. The number of these businesses was estimated indirectly based on the projected number of reports for organic chemicals and inorganic chemicals under the IUR amendments, as reported in Chapter III. EPA assumed that the ratio of the number of businesses reporting for inorganic chemicals to the number of businesses reporting for organic chemicals, based on the CUS Database, was the same as the ratio of the number of reports for inorganic chemicals ( based on the CICIS Database) to the number of reports for organic chemicals. In other words:

# Inorganic Businesses = (# Inorganic Reports/# Organic Reports) x (# Organic Businesses) # Inorganic Businesses = ( 4,502/ 16,576) x 758 Number of Inorganic Businesses = 206 39 Please note that sums may not add due to rounding.

VII 5 Based on the analysis of sales information for small businesses producing organic chemicals, the number of inorganic businesses can be broken down into small, medium and large companies. Using the percentages derived through the proportional allocation method and presented in Table VII 1, the breakdown of inorganic businesses is calculated as 120 large companies, 43 medium companies and 43 small companies. Using the percentages derived through the second method, placing all companies for which information was unavailable into the small business category, the breakdown of inorganic businesses is calculated as 99 large companies, 37 medium companies, and 72 small companies. 39 iii. Total Number of Businesses The total number of businesses submitting reports for organic and inorganic chemicals combined is estimated to be 964 businesses. Under the proportional allocation method, there are estimated to be 560 large, 202 medium, and 202 small businesses. Under the small business allocation method, there are estimated to be 461 large, 170 medium, and 336 small businesses.

However, 964 may be an overestimate of the total number of businesses expected to report under the proposed IUR amendments because some businesses may submit a form for both organic chemicals and inorganic chemicals. These companies would tend to be double counted, once as an inorganic chemical business and once as an organic chemical business, according to the approach presented in this analysis.

B. Analysis of Economic Impacts According to the 1997 EPA Interim Guidance for Implementing the Small Business Regulatory Enforcement Fairness Act and Related Provisions of the Regulatory Flexibility Act ( U. S. EPA 1997b), the RFA does not define " significant economic impact on a substantial number" of small entities. The criteria recommended by the guidance for evaluating the impact on small businesses is the annualized compliance cost of the rule as a percentage of sales. If the cost is less than 1 percent for all affected small entities, regardless of the total number of small entities affected, then the rule is presumed not to have a significant economic impact on a substantial number of small entities. 40 The contents, administration, and results of the survey are described in detail in Appendix D.

VII 6 The RFA requires that EPA consider only the effects of the IUR amendments ( i. e., the amendment to the existing rule). Throughout the development of the estimates, the following assumptions were used:

each site produces an average of 8.4 reports ( CUS Database 1997); and

each small business has one site.

The assumption of one site per small business is supported by the results of the industry survey. 40 Small companies that were surveyed reported that an average of 1.2 sites manufacture a single IUR reportable chemical. This chapter also presents a sensitivity analysis examining the impact on costs if more than one site per small business is assumed.

1. Determination of Individual Small Business Impact a. IUR Amendments  Small Business Compliance for Partial Form Completion of a partial form is required for chemicals with volumes of between 25,000 pounds and 100,000 pounds or for chemicals meeting one of the partial exemptions. Because small businesses are exempt from reporting chemicals with volumes under 100,000 pounds, only those meeting the partial exemptions with production volumes of 100,000 pounds or greater will be required to report. It is not known how many small businesses would complete the partial form, because the methodology for determining the total number of small businesses is based on data of previous reporting under the IUR. Data are therefore not available for those companies that are currently exempt. Because estimates of the number of small business completing only the partial form are unavailable, it is assumed that all will complete the full form. This assumption will tend to overestimate the total costs of compliance.

In the event that there are small businesses that would complete the partial form, estimates of the costs of compliance are presented. For organic chemicals, the average incremental cost of compliance with the amendments is estimated to be between $ 5,780 and $ 10,407. Dividing this cost by the average annual sales of $ 16.5 million, the average burden to sales ratio is 0.04 percent to 0.06 percent for organic chemical small businesses filing the partial form. For small businesses manufacturing inorganic chemicals volumes between 25,000 and 100,000 pounds, the average VII 7 incremental cost of compliance with the IUR amendments is estimated to be between $ 9,489 and $ 15,820 ( note that the baseline costs for inorganic chemicals is zero). Dividing this cost by the average annual sales of $ 16.5 million, the average burden to sales ratio for small businesses reporting to the IUR is approximately 0.06 percent to 0.10 percent for inorganic chemical small businesses filing the partial form.

b. IUR Amendments  Small Business Compliance for Full Form Completion of a full form is required for chemicals produced at volumes of 100,000 pounds or greater and not meeting one of the partial exemptions. For analytical purposes, EPA has assumed that all of the small businesses fit into this category. The average incremental cost of compliance for completing the full form for organic chemicals is between $ 21,169 and $ 27,112. Dividing this cost by the average sales of $ 16.5 million for small businesses, the average burden to sales ratio is approximately 0.13 percent to 0.16 percent. For inorganic chemicals manufactured at volumes above 100,000 pounds, the average incremental cost of compliance with the IUR amendments for an average small company was estimated to be between $ 24,879 and $ 32,526. Dividing this cost by the average sales figure of $ 16.5 million, the average burden to sales ratio for small businesses reporting on inorganic chemicals to the IUR is approximately 0.15 percent to 0.20 percent.

It has been assumed for this analysis that there is, on average, one site per company for small businesses. As mentioned earlier in the chapter, this assumption is supported by the results of the industry survey, which indicated an average of 1.2 sites per small business. Even though the assumption of one site per small business may tend to marginally underestimate the number of sites per company, it is important to note that small businesses would have to average between 5 and 28 sites per company in order for a cost greater than 1 percent of annual sales to be incurred.

Additionally, the assumption of one site per small business is offset by another assumption that may tend to overestimate costs. Specifically, the estimated number of reports ( 8.4 reports) per site used in the analysis may be an overestimate of the expected number of reports per site for small businesses because smaller sites tend to produce fewer chemicals ( ICF 1996).

The impact of the proposed IUR amendments on small businesses that produce inorganic chemicals only ( as opposed to those that produce organic and inorganic chemicals or only organic chemicals) will be slightly higher than the incremental cost of the amendments for small businesses as a VII 8 whole, attributable to the fact that the baseline costs for inorganic chemicals are zero. These additional costs are small, however, and the increased burden as a percentage of sales is approximately one hundredth of a percent. Table VII 2 summarizes the effect of the IUR amendments on small businesses.

As the table indicates, approximately 43 to 72 small businesses that produce only inorganic chemicals would be required to report under the proposed IUR amendments.

As presented in Table VII 2, the economic burden of the IUR amendments on small businesses does not exceed 1 percent of the annual sales for an average small business. In fact, small businesses producing organic chemicals and completing the full form would need to have annual sales of less than $ 2.7 million ($ 27,112 divided by one percent) to experience a significant economic impact. Small businesses producing inorganic chemicals and completing the full form would need to have annual sales of less than $ 3.2 million ($ 32,526 divided by one percent). Given the estimated mean annual sales of $ 16.5 million for small businesses potentially reporting to the original IUR, the typical small business will not experience a significant economic impact from the proposed changes to the rule. Because the amendments will not significantly impact a substantial number of small entities, EPA has determined that an Initial Regulatory Flexibility Analysis ( IRFA) is not necessary for the proposed IUR amendments.

Table VII 2. Effect of IUR Amendments on Small Businesses Allocation Strategy Facility, Manufacturing, Processing, and Use Information ( Production volume greater than 100,000 pounds)

Organic Chemical Reporters Inorganic Chemical Reporters Number Affected Percent of Sales Number Affected Percent of Sales Allocated by Proportions 159 0.13  0.16 43 0.15  0.20 Allocated as Small Businesses 264 0.13  0.16 72 0.15  0.20 Notes: Impacts are overestimated because it is assumed that all small businesses would complete the full form. The incremental cost as a percentage of sales for completion of the partial form is lower than for the full form. These numbers are presented in the text above. Sums may not add due to rounding.

Sources: CICIS Database 1986, CUS Database 1996, CUS Database 1997, ICF 1996, Ward's Business Directory 1996, D& B 1996, D& B 1992, Thomas Register 1990.

2. Sensitivity Analysis The analysis above assumes an average of one site per small business. As mentioned,

this assumption is confirmed by the survey results indicating an average of 1.2 sites per small business.

To determine the impact of varying the assumption of one site per small business, this section presents a sensitivity analysis assessing the effect on incremental costs of assuming two sites per small business. VII 9 Again, because only small businesses meeting the partial exemptions with production volumes of 100,000 pounds or greater will be required to report, it is assumed that all will complete the full form. In the event that there are small business that would complete the partial form, estimates of the costs of compliance are presented.

The cost of reporting under the IUR amendments assuming two sites per business is double the cost of reporting under the assumption of one site per business. However, as presented in Table VII 3, the economic burden on small businesses still does not exceed 1 percent of the annual sales for an average small business. Therefore, the results of this sensitivity analysis confirm that an Initial Regulatory Flexibility Analysis ( IRFA) is not necessary for the proposed IUR amendments.

Table VII 3. Effect of IUR Amendments on Small Businesses Assuming Two Sites Per Small Business Allocation Strategy Facility, Manufacturing, Processing, and Use Information ( Production volume greater than 100,000 pounds)

Organic Chemical Reporters Inorganic Chemical Reporters Number Affected Percent of Sales Number Affected Percent of Sales Allocated by Proportions 159 0.26  0.33 43 0.30  0.39 Allocated as Small Businesses 264 0.26  0.33 72 0.30  0.39 C. Environmental Equity/ Justice Executive Order 12898, Federal Actions to Address Environmental Justice in Minority Populations and Low Income Populations requires that all federal agencies address the issue of environmental justice by identifying and revising programs, policies, and activities that may disproportionately and adversely affect the health of minority or low income populations or their environments.

Because the proposed IUR amendments are an information collection exercise, there are no negative environmental equity issues associated with them. Instead, the information that would become available through the proposed rule would enable the Agency to target educational, regulatory, or enforcement activities towards industries or chemicals that pose the greatest risks and/ or to target programs for geographic areas that are at the highest risk. Thus, the information proposed to be gathered under the IUR amendments would help EPA to make decisions that will benefit potentially

atrisk communities, some of which may be disadvantaged. 41 High site reporting is defined as 100 or more reports from IUR submitting sites.

VII 10 To illustrate the way in which information proposed to be collected under the IUR amendments would benefit minority and economically disadvantaged persons and communities, geographic areas with high site reporting41 have been compared with social and economic characteristics of the populations potentially affected by the proposed amendments. A significant portion of low income and minority communities are in proximity to IUR sites. Specifically, of the 121.2 million people who lived within 10 miles of an IUR site ( 49 percent of the 1990 U. S. population), almost 38 million ( 30 percent) were minorities. This number is greater than the nationwide figure of approximately 49 million ( 20 percent)

minority individuals, out of the total 1990 U. S. population of 248.7 million. Roughly 24 million ( 20 percent) of the people living within 12 miles of an IUR site were at or below 150 percent of the poverty level. This is consistent with the census figure of 52.5 million ( 21 percent) individuals at or below 150 percent of the poverty level nationwide ( U. S. Census 1990).

The information proposed to be collected through the IUR amendments would allow EPA to focus risk screening and assessment activities on chemicals with high exposure profiles and risks.

Additionally, because the IUR amendments data would allow EPA to view chemical exposures and uses on a regional or local level, it is possible that analyses could be undertaken that would benefit disadvantaged groups. Specific activities to benefit these groups could include information dissemination, community awareness, exposure mitigation, pollution prevention, outreach and educational programs, and consumer protection programs. In addition, EPA may share aggregated information with non governmental organizations ( NGOs), private sector stewardship programs, other federal programs such as OSHA and CPSC, and other federal and state government agencies, resulting in worker or consumer oriented programs or local, state, and regional programs targeting disadvantaged groups.

Additionally, as discussed in Chapter V, the information that would be collected under the proposed IUR amendments would aid in targeting potential health and ecosystem risks. Minority and economically disadvantaged groups would benefit from these potential risk reductions even if programs specifically targeting disadvantaged persons do not exist. Because the production volume information currently available to EPA is not always sufficient for identifying chemical exposures and human risks, VII 11 better compilation of use and exposure data would enable EPA to predict more accurately the magnitude and nature of ecosystem and human population exposure. This better information on uses and exposures would potentially benefit minority and economically disadvantaged groups by alerting them to the chemical exposure risks in their workplaces and communities.

Additionally, the availability of better information would also enable EPA to conserve resources and focus efforts on chemicals that pose higher risks, and thereby potentially more effectively and expeditiously reduce the risks posed by these chemicals. For example, worker exposure information would be used to develop priorities and to determine chemicals or uses that require a more detailed risk screening or assessment. The rapid identification of potentially high risk situations would also allow for a more timely and efficient identification and development of safer substitutes and alternative chemicals,

processes, and technologies, thereby benefiting all potentially exposed employees ( including disadvantaged ones) that work at chemical manufacturing, importing, and processing sites. Although programs and safety measures would not have been targeted to a specific subset of workers,

disadvantaged persons employed at these sites would benefit from EPA's improved ability to target risks and thereby more efficiently implement the programs and safety measures necessary to reduce these risks. R 1 REFERENCES BLS ( Bureau of Labor Statistics). 1997 ( April 5). Transcribed Telephone Conversation with Wayne Shelley, Office of Compensation Levels and Trends, Bureau of Labor and Statistics, Washington, DC.

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DRAFT REPORTING FORM FOR THE PROPOSED IUR AMENDMENTS B 1 APPENDIX B. CURRENT DATA COLLECTION There are currently a number of chemical data sources maintained by EPA and other federal and state agencies, as well as publicly available databases, that contain limited information on production,

processing, emissions, and other chemical data. However, these sources generally do not contain the type of chemical use and/ or exposure data necessary for EPA to conduct more effective chemical risk screening. The more detailed collection of use and exposure information proposed under the IUR amendments would provide EPA with the means to better determine those chemicals with the greatest potential for risk, and thereby conduct more effective risk management activities. This appendix describes the information available in each of the currently available sources as compared to the data that is proposed to be collected under the IUR amendments. Additional information can be found in " A Review of Existing Exposure Related Data Sources and Approaches to Screening Chemicals: A Response to CMA" ( U. S. EPA 1998a).

1. Air Programs and Datasets

The Office of Air Quality Planning and Standard ( OAQPS) maintains the Aerometric Information Retrieval System ( AIRS), a national repository for information on seven types of airborne pollution in the United States. The AIRS Facility Subsystem ( AFS), one of the four AIRS components, is used to track point source emissions and compliance data from industries.

Information collected includes plant compliance summaries, emissions by SIC code, and the extent and distribution of emissions ( U. S. EPA 1996a). This collection focuses on air emissions and does not contain information on specific chemical production volume, uses, or worker exposure scenarios.

The Office of Air and Radiation ( OAR) tracks chemical use, hazard, and risk information for approximately 150 chemicals that are replacements for ozone depleting substances ( ODS). The B 2 information is collected under the Significant New Alternatives Policy ( SNAP) Program. This data set does not collect the detailed chemical exposure and use information called for by the IUR amendments.

2. Solid and Hazardous Waste Programs and Datasets

The Office of Solid Waste and Emergency Response ( OSWER) manages the Biennial Reporting System ( BRS). The BRS data describes the aspects of, and monitors the trends in, hazardous waste generation, management, and minimization for RCRA large quantity generators and for treatment, storage, and disposal facilities subject to RCRA permitting requirements. Although the data set contains information on the chemical constituents in hazardous waste from the paint,

petroleum, and pesticides industries ( U. S. EPA 1996a, McBride 1996), it does not contain information on specific chemical use, worker exposure scenarios, production volumes, or production locations.

The Office of Emergency and Remedial Response ( OERR) is responsible for compiling the Oil and Hazardous Material Technical Assistance Data System ( OHMTADS), which contains information on hazardous substances including: chemical name, physical/ chemical properties,

lists of regulations covering production and use data, safety and toxicity data, and response information ( U. S. EPA 1996a) for large volume industrial chemicals transported in bulk quantities. This data set does not contain the data proposed to be collected under the IUR amendments.

The Office of Solid Waste ( OSW) maintains the Resource Conservation and Recovery Information System ( RCRIS), a national system supporting the Resource Conservation and Recovery Act ( RCRA) program. This system tracks events and activities related to facilities that generate, transport, treat, store, or dispose of hazardous waste ( U. S. EPA 1996a); however, the dataset does not collect detailed chemical use or exposure information at the level called for by B 3 the IUR amendments. Additionally, RCRA reporting does not account for chemicals used within a facility that are not disposed of or treated as hazardous waste.

3. Water Programs and Datasets

The Office of Ground Water and Drinking Water ( OGWDW) maintains the Federal Reporting Data System ( FRDS), a repository of information about Public Water Supplies ( PWS) and their compliance with requirements of the Safe Drinking Water Act ( SDWA) of 1986 ( U. S. EPA 1996a). This database does not include chemical exposure, end use, manufacturer, or production information as would be required under the IUR amendments.

The Office of Water ( OW) compiles the Permit Compliance System ( PCS), a computerized management information system containing data on National Pollutant Discharge Elimination System ( NPDES) permit holding facilities. Each permit record contains information that identifies permits, pollutant discharge limits, pollutants discharged in wastewater, and facility compliance schedules and violations. This database only contains industry specific information about the amount and type of chemicals discharged from various manufacturing and service industries, not information on site specific chemical production, worker exposure, or chemical end use ( Rubin 1996, Strasler 1996, U. S. EPA 1996a).

4. Pollution Prevention and Toxic Substances Programs and Datasets

The Office of Pollution Prevention and Toxics ( OPPT) administers the Toxic Release Inventory ( TRI), which contains site specific information on the amounts of approximately 540 individually listed toxic chemicals and 22 categories of chemical compounds released directly to air, water,

or land or transferred off site. Because the database only collects information on chemical releases, it does not contain site specific information on chemical production, use, or worker exposure ( U. S. EPA 1996a). B 4

The Office of Pollution Prevention and Toxics ( OPPT) maintains the Premanufacture Notification ( PMN) database under the TSCA § 5 New Chemicals Program. The database contains physical/ chemical properties, use and predicted production information, worker exposure information, and process related information for " new" chemicals submitted for approval to begin commercialization. This data set provides information only on new chemicals and, therefore,

has a negligible overlap with the data proposed to be collected under the IUR amendments.

The Office of Pollution Prevention and Toxics ( OPPT) developed a joint voluntary program in cooperation with CMA, SOCMA, CSMA, and API. The program, entitled the Use and Exposure Information Voluntary Project, allows EPA to collect chemical use, exposure, and release information for certain chemicals targeted under EPA's Risk Management ( RM) program.

Information has been collected in three groups ( two in 1994 and one in 1996) for 15 20 chemicals per group from a total of approximately 100 facilities. Because of the voluntary nature of the program and the limited number of chemicals examined, the data are not collected for most manufactured chemicals. Therefore, data generated from this project would have limited usefulness for initial risk screening activities. Rather, the data serves to inform the second step of risk characterization, after an initial risk screening. In other words, UEIP provides detailed information on a small number of chemicals for a select number of facilities, but it would be difficult to extrapolate from this data set to develop a nationwide picture of use and exposure.

The Office of Pollution Prevention and Toxics ( OPPT) requires that chemical manufacturers and importers report facility identification, manufacturing, use, and exposure information as part of the Primary Assessment Information Rule ( PAIR). The type of information collected under the PAIR is similar to the type of information proposed to be collected under the IUR amendments.

However, the PAIR information is collected for only a very small, select set of chemicals during each reporting period, and the chemicals that are targeted by PAIR change from year to year based on the priorities of the Interagency Testing Committee. Therefore, the information collected under the PAIR provides only a snapshot of the use and exposure of a small set of B 5 chemicals each year rather than a periodically updated record of toxic chemical manufacture,

exposure, and use. B 6 5. Research and Development Programs and Datasets

The Office of Health and Environmental Assessment ( OHEA) maintains the Integrated Risk Information System ( IRIS), a database that contains summaries of health risk and EPA regulatory information on more than 500 specific chemicals. The database is not linked to chemical use and does not provide site specific characterizations of workplace exposure scenarios or production volumes.

6. State Agency Data Collection Efforts

Massachusetts maintains a database of emission and process information ( i. e., quantity produced, process and end product description, and certain chemical identification and property information) from manufacturers, users, and processors within Massachusetts only. This database is part of an effort to reduce toxic wastes in the state ( Hope 1996). The information is collected under the Toxic Use Reduction Act ( TURA); however, no exposure information regarding the number of potentially exposed workers or uses of the chemical ( NAICS codes,

consumer uses, etc) is collected under TURA ( MADEP 1995).

New Jersey collects production volume and end use information under the NJ state Toxic Catastrophe Prevention Act ( TCPA), supporting a risk management program for companies that manufacture, process, possess or use chemicals above certain chemical specific threshold levels. The threshold levels are developed for each individual chemical covered under the program based on volatility and toxicity, and may range from as low as 100 pounds to greater than 100,000 pounds. The information collected is specific only to production and end uses within the state of New Jersey. Although companies are required to report chemical information as part of the state's risk management program, chemicals shipped in or out of a site as product are not tracked. Information reported primarily relates to release scenarios ( i. e., quantity of chemical released from the site into the air or water or as solid/ hazardous waste). Additionally,

no worker exposure data is collected under this program ( Larmee 1996). B 7

Oregon gathers facility and chemical specific data on the volume of toxic materials used or brought on site as part of the Toxics Use Reduction and Hazardous Waste Reduction Act ( TURHWRA) of 1989. The primary component of this law is that all facilities in Oregon that report under the Federal Community Right to Know TRI requirements or are hazardous waste generators must develop and submit facility plans to reduce toxic chemicals use and hazardous waste generation. TURHWRA does not contain information on the number of potentially exposed workers or provide detailed information on chemical production or use pathways.

However, the requirements under TURHWRA do provide a snap shot of on site use of toxic chemicals for key facilities in Oregon ( Rozell and Brower 1993, OSPIRG 1993).

7. Other Federal Agencies and Data Collection

The Emergency Response Notification System ( ERNS) is maintained by the U. S. Department of Transportation and is used to store information on notifications of releases of oil and hazardous substances into the environment. ERNS combines data from the National Response Center's Database with data from the 10 EPA Regions ( U. S. EPA 1996a). Release reports are available for ( 1) substances designated as hazardous under the Comprehensive Environmental Response,

Compensation, and Liability Act ( CERCLA), as amended, ( 2) oil and petroleum products, as defined by the Clean Water Act of 1972 ( CWA) and amended by the Oil Pollution Act of 1990,

and ( 3) all other types of materials. Information that can be found in the ERNS database includes, but is not limited to the following: the material and quantity released, where and when the release occurred, the agency notified, and any information about property damage, injuries,

and/ or deaths which occurred due to the release. However, there are several limitations to these data. ERNS data are focused on information about releases and not on manufacturing and use of chemicals. Secondly, the data are subject to a certain degree of uncertainty because ERNS contains primarily initial accounts of release made when exact details are often unknown. Lastly,

these data are usually not updated unless an EPA region is involved in the response action. B 8

The Occupational Safety and Health Administration ( OSHA) maintains data on the safety and health of workers, including worker exposure to potentially hazardous chemicals used in the workplace. This data focuses primarily on site specific/ problematic worker exposures. The data does not contain information regarding the number of workers across an industry that may be exposed to toxic chemicals in the workplace and does not track chemical use information.