Summary of EPA's Responses to Public Comments Submitted for the Proposed TSCA Inventory Update Rule Amendments ( 64 FR 46772)

US. Environmental Protection Agency Office of Pollution Prevention and Toxics 11/ 20/ 02 Table of Contents Acronyms......... p. 1 A. General Comments 1. Justification for Rule/ Practical Utility ......... p. 3 2. Ability to Use Data......... p 14 3. Other Sources of Data and Methods of Collecting Data......... p 18 4. Rule Development Process......... p 29 5. Right to Know Comments.......... p 30 6. Industrial Expionage and Terrorism......... p 31 7. Violating Federal Law........... p 36 B. Specific Data Elements Comments 1. General Data Quality and Accuracy...... p 39 2. Double Counting of Data....... p 43 3. Site and Company Identification...... p 46 4. Form U, Part II Data Elements  Manufacturing Information..... p 47 a. Production volume....... p 47 b. Concentration data....... p 48 c. Physical form.......... p 49 5. Form U, Part III Data Elements  Processing and Use Information.... p 50 a. General Downstream Reporting...... p 50 b. Process or Use Codes...... p 55 c. Industrial Function Categories....... p 56 d. Commercial and consumer product categories...... p 57 6. General Data Elements Comments........ p 61 a. " Reasonably Likely to be Exposed" Workers...... p 61 b. Personal Protective Equipment...... p 69 c. Metric System Reporting...... p 70 d. Use volume accuracy and reliability...... p 70 C. Reporting Universe Comments... p 71 1. Inorganic Chemicals..... p 71 a. Removal of Exemption for Inorganic Chemical Substances... p 71 b. Retention of Exemption for Inorganic Chemical Substances... p 71 c. Phasing in Reporting..... p 79 d. Alternatives for Reporting..... p 81 e. Specific Substances.... p 87 2. Natural Gas Exemption..... p 98 3. Petroleum Process Streams..... p 101 4. Other Chemical Categories..... p 102 a. HPV Chemicals... p 102 b. Low Priority Chemicals... p 106 5. Thresholds.... p 116 D. Definitions and Clarification Requests... p 120 1. Inorganic Chemical Substance... p 120 2. Chemical Industry... p 122 3. Site..... p 122 4. Importers.... p 123 E. Confidential Business Information... p 126 1. General CBI..... p 126 a. Protection of CBI... p 128 b. Disclosing customer confidential information.... p 129 c. Production volume ranges.... p 130 2. Up front Substantiation... p 130 3. Reassertion... p 132 F. Administrative Comments... p 136 1. Frequency of Reporting... p 136 2. Calendar year reporting... p 137 3. Form U comments... p 138 G. Economics... p 140 1. Burden... p 141 2. Cost... p 147 3. Benefits.... p 151 4. Small Business Analysis... p 152 5. E. O. 12866.... p 154 References.... p 155 Appendix 1: Docket Commenter Number Cross Reference List of Legacy Docket to E Docket Page 1 of 159 Acronyms ACC American Chemistry Council ( formerly the Chemical Manufacturers Association) ATSDR Agency for Toxic Substances and Disease Registry API American Petroleum Institute BRS Biennial Reporting System CAIR Comprehensive Assessment Information Rule CAS Chemical Abstracts Service CBI Confidential Business Information CCP Commercial and Consumer Product CMA Chemical Manufacturers Association ( now the American Chemistry Council) CPSC Consumer Product Safety Commission CSMA Chemical Specialty Manufacturers Association DfE Design for the Environment DOE Department of Energy EC European Commission ECP Existing Chemicals Program EPCRA Emergency Planning and Community Right To Know Act FDA Food and Drug Administration FIFRA Federal Insecticide, Fungicide, and Rodenticide Act GAO Government Accounting Office HPV High Production Volume IARC International Agency for Research on Cancer ICCA International Council of Chemical Associations IFC Industrial Function Category ITC Interagency Testing Committee IUR Inventory Update Rule IURA Inventory Update Rule Amendments MSDS Material Safety Data Sheet NAICS North American Industrial Classification System NCP New Chemicals Program NIOSH National Institute of Occupational Safety and Health NOES National Occupation Exposure Survey NOHS National Occupational Hazard Survey NTP National Toxicology Program OECD Organization for Economic Cooperations and Development OMB Office of Management and Budget OPPT Office of Pollution Prevention and Toxics OSHA Occupational Safety and Health Administration PAIR Preliminary Assessment Information Rule PMN Premanufacturing Notice PRA Paperwork Reduction Act PPE Personal Protective Equipment Page 2 of 159 RM 1 Risk Management 1 SAB Science Advisory Board SIAR SIDS Initial Assessment Report SIC Standard Industrial Classification SIDS Screening Information Data Set SOCMA Synthetic Organic Chemical Manufacturers Association TSCA Toxic Substances Control Act TRI Toxics Release Inventory UCSS Use Cluster Scoring System USGS U. S. Geological Survey UEIP Use and Exposure Information Project Page 3 of 159 A. General Comments 1. Justification for Rule/ Practical Utility Comment A. 1 1: Several of the commenters stated that EPA has not provided adequate justification supporting the Agency's need for the IURA data, and has not provided enough specific examples showing how the data would be used for EPA's intended purpose. Certain comments questioned whether EPA currently has an effective risk screening program in place to use the new IUR data as it is reported. Overall, commenters indicated that it is unreasonable for EPA to enact these amendments until a clearly articulated and specific plan for using the data is in place.

Source: C1 001, C1 010, C1 011, C1 014, C1 015, C1 016, C1 017, C1 018, C1 019,

C1 021, C1 023, C1 024, C1 026, C1 027, C1 031, C1 032, C1 033, C1 038, C1 041,

C1 044, C1 045, C1 046, C1 055, C1 056, C1 071 Response A. 1 1: EPA has developed a Data Use Plan ( Ref. 1), which more fully describes uses of the IURA data and provides selected specific examples of these uses. As explained in the plan, the IURA database will be a fairly shallow collection of exposure related information on a fairly large number of chemicals. As a whole, these data do not currently exist and EPA, through TSCA, is the only Agency that has the ability to reach so many chemicals and to collect this type of information on those chemicals on a regular enough basis that information remains current and trends can be identified. This exposure database is needed to:

° Support priority setting and risk based screening of chemicals ( for example, IURA data can be used to provide a risk based context for hazard information being submitted under the HPV Challenge Program);

° Empower resource allocation decisions;

° Provide a first place to look when a new concern is identified;

° Provide an overview of chemical processing and use, over time, in a unique database;

° Inform a variety of Agency and other programs, such as the TSCA testing program, OSW programs, and NIOSH, OSHA, and CPSC programs; and ° Provide initial exposure information for the development of Agency and public programs,

such as the Voluntary Children's Chemical Evaluation Program ( VCCEP) and Design for the Environment ( DfE) voluntary programs.

The data use plan contains specific examples to support these more general uses of the IURA Page 4 of 159 data.

Although the plan contains an example of a basic screening of the whole IURA database,

there are many other uses; data generated by the IURA will be used in a wide variety of programs fundamental to fulfilling the Agency's TSCA statutory mandate. These programs range from the more traditional existing chemicals risk screening efforts to voluntary programs to individual requests for analysis of chemicals not specifically associated with a particular program. The IURA database will be searched to identify chemicals or use scenarios meeting specific criteria.

For instance, if there was a need to identify chemicals that have the greatest potential for consumer exposure, the database could be searched, resulting in a listing of chemicals arranged according to the production volumes associated with different consumer uses. The Agency anticipates that, as was true even for the basic production data reported under the existing IUR,

new uses of IURA data by EPA and by others will continually emerge and cannot be predicted at this time.

Results from EPA tools such as the Use Cluster Scoring System ( UCSS) will be greatly improved by the IURA data. The UCSS is a computerized tool that combines hazard and exposure information from a variety of data sources, analyzes the data in relation to groupings by commercial use, or " clusters," and identifies clusters of potential concern to EPA. The EPA Science Advisory Board ( SAB), in its evaluation of the UCSS, commented that there has been a lack of exposure information in the system, which has impaired the utility of the system. ( Ref. 2)

The IURA database will provide exposure information that the UCSS will be able to directly download and use. ( For a description of UCSS, see http:// www. epa. gov/ opptintr/ cbep/ actlocal/ 39 use. htm.)

EPA will also use IURA data to perform preliminary exposure and risk screening across a portion of the Inventory chemicals. Some of the data of the type that will be collected under IURA have been collected under the Agency's TSCA Existing Chemicals Program ( ECP) and in the TSCA New Chemicals Program ( NCP), and have aided EPA in performing exposure and risk screening These exposure related data were submitted as part of programs such as the voluntary Use and Exposure Information Project ( UEIP) ( see http:// www. epa. gov/ opptintr/ sids/ vueip. txt for a description of this project) and the Premanufacture Notice ( PMN) program under TSCA section 5. Although the UEIP and PMN programs involve the submission of certain data that are the same as or similar to data that will be submitted under IURA, these programs cannot sufficiently serve the needs that IURA will fill ( see Units V. A. 1. and V. B. 5. of the proposed rule ( 64 FR 46772, 46775 and 46780)). However, these programs do serve as examples of the usefulness of certain IURA data elements. Page 5 of 159 For example, several IURA data elements were utilized in an Existing Chemicals Program initial review of the chemical methyl ethyl ketoxime ( MEKO) ( Ref. 3). This review relied in part upon data submitted by industry under the UEIP, some of which are similar to those that will be reported under IURA and include the following: production volume, manufacturing process,

industry sector, industrial processing/ use activity, functional use, number of sites, number of workers, physical/ chemical properties, and consumer product information. Other UEIP information submitted by industry on MEKO are not of the sort that will be collected under IURA, such as environmental releases ( releases to air, water, etc.), worker exposure activities and monitoring data. IURA is designed to obtain information that is the most critical for generating screening level exposure profiles.

The UEIP submissions for MEKO showed that there were one manufacturer and two importers of MEKO in 1993. Five primary end uses with the percentages of MEKO production and import volumes devoted to each use were indicated in these submissions. The number of workers at the manufacturing site, the physical forms of products containing MEKO and the MEKO weight fraction in each use were also reported.

The MEKO use information was combined with data and information from some available workplace monitoring studies and modeling approaches to develop a screening level workplace exposure assessment. The UEIP information on use provided crucial information to allow EPA to postulate process operations, worker activities, and possible exposures. For example, MEKO's primary use ( 92% of production and import volume) is as a paint additive. This fact allows EPA to refer to information on paint manufacturing and use to estimate exposures to workers who either formulate paints or apply the paints using spray guns or other techniques. MEKO use in paint indicates a potential for exposure to several large populations ( workers and consumers)

because even small amounts of paint can result in significant exposure levels to chemicals in paints. Such use information can also be used by EPA to generate estimated numbers of workers in very small businesses (< 10 workers) that may be poorly represented by existing National Occupation Exposure Survey ( NOES) data; in the MEKO case, such a population would be commercial painters. Without the information about MEKO use in paints and the large percentage of MEKO volume devoted to this use, exposed populations and exposure level estimates may have been severely underestimated or left as a data gap ( not estimated). Such underestimations and data gaps can artificially lower the appropriate level of concern for potential risk( s) from a chemical.

The usefulness of IURA data elements is also demonstrated by EPA's use of similar data in its New Chemicals Program. Premanufacture Notices ( PMNs) for new chemical substances Page 6 of 159 submitted to EPA under TSCA section 5 require many of the same exposure related data elements that will be reported under the IURA. Exposure related data in PMNs include estimates of production volume, categories of use, percent production volume in the categories of use,

maximum numbers of workers exposed, and concentrations and physical forms of the chemical.

EPA uses these exposure related data to generate screening level risk assessments for regulatory decision making under TSCA section 5.

In a recent PMN submission, the manufacturer of a new chemical provided the following information: an estimated import volume; chemical uses and the percentages of the import volume devoted to each use ( cosmetic applications exempt from TSCA ( 25%) and non cosmetic applications as a component of a fragrance formulation used in household products such as detergents, cleaners, soaps, room fresheners, etc. ( 75%)); numbers of sites and workers; and consumer product information ( weight percent in products). Using this information in combination with technical references and other research, EPA was able to estimate the number of manufacturers of household products who may use the new substance. Releases of the new substance from the fragrance formulation process and from the household products manufacturers were estimated, resulting in estimated environmental concentrations of the new substance due to its release and estimated general population exposures to the new substance. EPA also used the information on processing and use in combination with modeling techniques to estimate the numbers of workers and consumers who may be exposed to the new substance and their estimated exposures to the new substance. These exposure related estimates, when combined with information on the estimated hazards of the new substance, indicated that the estimated risks to potentially exposed workers, the general population, consumers, and aquatic species were all below levels of concern. Therefore, since EPA did not identify any significant risks, the Agency could determine that no further regulation under TSCA section 5 was needed for this new substance. Without the limited processing and use information from IURA reporting, the Agency would have to rely only on generic assumptions for approximating potential exposures. Using generic scenarios only is too inaccurate to use to evaluate exposures; the Agency needs the IURA information to begin incorporating exposure into screening efforts.

Information from IURA may also be used in efforts to identify single chemicals, in order to support potential exposure prevention efforts. For example, EPA recently learned that certain imports of zinc sulfate were contaminated with cadmium. Using the IURA processing and use data on inorganic substances, EPA could have quickly identified importers of zinc sulfate and segments of industry or the general population that might use the chemical. EPA could then have targeted warnings of the potential for exposure to cadmium more effectively, thereby preventing Page 7 of 159 exposures to these groups likely to be the most highly exposed.

The TSCA Interagency Testing Committee ( ITC) will use IURA to identify chemicals as candidates to recommend for further testing or information reporting. The ITC has sixteen ( 16)

U. S. Government member organizations. The National Toxicity Program ( NTP) determines the need for federally funded research for determining the toxicity of chemicals. IURA information could be used to identify the chemicals with exposure concerns, thereby identifying those chemicals for which NTP will need to determine toxicity.

Other Federal agencies have also long recognized the need for and importance of exposure data. OSHA, NIOSH, and CPSC have written letters supporting EPA's and their own need for exposure data ( Refs. 4, 5, 6, 7, and 8). In May 2000, the Government Accounting Office ( GAO)

stated that " Various federal agencies have collected such human exposure data for a number of purposes; historically, these collection efforts have been limited to selected chemicals,

subpopulations, and time periods" ( Ref. 9).

Other government agencies, industry, public interest groups, and the public in general will also be able to access and use non CBI IURA information. The IURA exposure related data will be important to users beyond those who accessed the current IUR in the past solely for production volume information. For instance, the Natural Resources Defense Council has expressed interest in using the IURA information ( Ref. 10). Persons interested in reviewing the HPV Challenge Program screening level hazard data ( see http:// www. epa. gov/ opptintr/ chemrtk/ volchall. htm) will be able to use the exposure related IURA data ( to the extent that IURA data is not CBI) to put the hazard data into context. Risks identified via evaluation of this screening level hazard and exposure data then can be addressed.

Other examples of uses by non EPA groups are:

CPSC: The U. S. Consumer Product Safety Commission ( CPSC) will utilize IURA data to assist in identifying household chemical product ingredients, which may lead to a determination of which products should be labeled as " hazardous substances."

Currently, there is no comprehensive source of information on the ingredients of household chemical products and CPSC does not have the authority to collect this type of comprehensive information. ( Refs. 6 & 7)

OSHA: The Office of Safety and Health Administration ( OSHA) strongly supports EPA's collection of information on the processing and use of chemicals. The addition of information which links the number of potentially exposed workers to specified quantities of specific chemicals at specific establishments would be extremely useful to OSHA in setting priorities, developing health standards, and targeting intervention efforts including Page 8 of 159 outreach and training. This information will be instrumental in helping OSHA identify which industry groups have a greater potential for worker exposure issues, to identify which chemicals have limited concerns and which are of potential concern to which industries, and to identify changes in industry behavior and use patterns. ( Ref. 4)

States: IURA would provide the data needed by states to focus their multimedia pollution prevention ( P2) initiatives. While the initiatives vary from state to state in focus and design, a shared characteristic is that there is an initial examination of the whole plant, the full range of public health and environmental protection issues,

and existing regulatory controls. Through this multifaceted, multi media review,

the states reexamine the overall management scheme and, in partnership with industry, rework the overall management plan to more efficiently address environmental and public health risk. Improved targeting of these programs,

possible with the use of IURA data, would save both the program office and industry partners time and money. States can also utilize IURA information to support their State Regulatory Development Processes. IURA would also provide information to states for use in addressing Federal delegated responsibilities ( CAA and CWA permit authorities, etc.) and state authorities ( California Proposition 65,

etc).

This response described a wide variety of uses for the new IURA exposure related data.

However, the Agency anticipates that even more opportunities exist for use of this information, as was true even for the basic production data reported under the current IUR.

Discussions of the need for and expected uses of the IURA data are in the preamble to the proposal, the economic analysis, letters to the Office of Management and Budget ( OMB), and in the report " EPA Needs Exposure Related Data: A Discussion of the Justification for Collecting Exposure Related Data Through the IUR Amendments" ( Ref. 11). All of these documents are in the public version of the official record for this rulemaking, docket number OPPT 2002 0054.

Comment A. 1 2: Commenters suggested that EPA should use a more targeted approach to collect only the information for which there is defined utility. Commenters questioned why EPA needs information on chemical substances that have already been screened.

Source: C1 045, C1 056 Response A. 1 2: Contrary to the commenters' belief, EPA is collecting targeted Page 9 of 159 information for which there is a defined utility. As described in the documents listed in comment A. 1 1, EPA and others have a need for a broad based source of screening level use and exposure information on chemical substances. A primary purpose for collecting IURA data is to enable the Agency to screen a relatively broad set of Inventory chemicals based on potential exposure. The Agency and others will be able to use the screening results to help focus efforts and resources by identifying those chemicals that warrant further analysis, as well as setting priorities for conducting further analyses, including hazard testing, risk assessment, and risk management. This basic information on exposure and use will allow the Agency to consider available hazard information in the context of potential exposure.

EPA focused the IURA on a subset of chemicals on the TSCA Inventory. The Agency is requiring the reporting of processing and use information on only 4,000 of the more than 76,000 chemicals listed on the TSCA Inventory. Additionally, EPA has eliminated processing and use reporting for listed petroleum processing stream chemicals and for specific listed chemical substances for which EPA has a low current need for IURA processing and use information.

Further restricting the chemicals for which data are collected would reduce the effectiveness of this screening tool and ultimately the effectiveness and efficiency of various risk management programs. Instead of having a database of information that allows EPA to act proactively,

identifying areas of potential concern for exposure or risk, and to react in a timely manner to requests and demands for action for specific concerns, EPA would have to identify which chemicals are going to be of interest for the future  up to eight or ten years before the information is needed. Additionally, EPA would not have a baseline of information to track the progress of different Agency and public programs, would not be able to identify trends in the industry, and would not be able to help identify future issues associated with chemical substances ( i. e., identifying that the use of a specific chemical is increasing).

At times, EPA needs to collect further screening level information on chemicals which have already been screened. One very basic reason for this need is the fact that, although a chemical's toxicity is inherent to the chemical itself, exposures associated with that chemical may vary substantially over time. As a result, a chemical that appears to be very risky due to high exposure could appear much less so if that exposure is reduced over time. Alternatively, a chemical that does not appear to be risky due to low exposure could appear much more so if that exposure increases over time. Screenings need to occur periodically in order to account for such changes  otherwise, the screenings and data become outdated and less reflective of current conditions.

There are a variety of other reasons EPA may need further screening level information on Page 10 of 159 chemicals which have already been screened.

$ Chemicals are often screened for specific purposes, such as for a specific end use or type of release. IURA data will enable the Agency to identify other issues of importance for chemicals that have already been reviewed.

$ Both regulatory and voluntary programs may be instituted for chemicals that have been reviewed. The effectiveness of these programs may be evaluated using IURA data by tracking the volumes of particular chemicals being produced or the rate of increase or decrease of particular end uses.

$ New issues associated with a chemical may arise. For example, if the Agency saw the need for an enhanced focus on children's health, a chemical previously screened or assessed may need to be reexamined. Another example is the discovery of the importance of endocrine disruption and the need for information as to whether a particular chemical may have endocrine disrupting potential.

The chemical industry is a dynamic, ever changing industry. New uses for chemicals are discovered, or old uses revived. With information submitted on chemicals that have already been screened or otherwise assessed, the Agency can identify trends associated with those chemicals.

The trend information will allow the Agency to identify, upfront, new issues associated with a chemical or a particular type of use or exposure.

Comment A. 1 3: Commenters stated that EPA is violating the Paperwork Reduction Act ( PRA) of 1995 by failing to demonstrate that the proposed collection of information is necessary for the proper performance of the functions of the agency and that the information shall have practical utility as required by Section 3506 of the PRA.

Source: C1 024, C1 033, C1 038, C1 044, C1 069 Response A. 1 3: EPA has demonstrated that the IURA is " necessary for the proper performance and functions of the agency." TSCA mandates that EPA control unreasonable risks of chemicals in commerce. For new chemicals, EPA requires firms wishing to introduce chemicals into commerce to supply the information of the sort that will be required by the IURA.

EPA has had little information to use to screen the risks posed by the roughly 76,000 existing chemicals in commerce. IURA offers the opportunity to partially address this lack of data.

Any screening of " risk" is based on some amount of hazard information in combination with some amount of exposure information. EPA relies on risk screening to indicate which Page 11 of 159 chemical substances may present a risk, and thus warrant more resource intensive assessment.

The EPA Science Advisory Board's " Reducing Risk: Setting Priorities and Strategies for Environmental Protection" report ( Ref. 12) and the National Academy of Public Administration's " Setting Priorities, Getting Results, A New Direction for EPA" report ( Ref. 13) recognize that EPA's ability to set priorities through risk screening and EPA's ability to allocate its limited resources has been significantly impeded by a lack of exposure data. Industry agrees that EPA needs exposure data. In a letter to EPA dated March 24, 2000, CMA ( now ACC) supported collecting exposure information to evaluate chemicals in EPA's voluntary Children's Safety Program ( Ref. 14). CMA stated that " exposure assessment has long been recognized as one of the weak links in the risk assessment process. Real data have been hard to come by, and default assumptions have often bordered on the absurd" ( Ref. 15). Screening the potential risks posed by the chemical substances included in the TSCA Inventory and setting priorities for more detailed risk assessment and possible risk management is an enormous challenge. The manufacturing,

processing, and use of Inventory chemicals result in a wide array of exposure scenarios. By collecting the exposure related data included in IURA, the Agency will acquire information that will greatly improve EPA's ability to identify, through risk screening, the chemical substances that could pose a risk to human health and to the environment.

The term " practical utility" is defined in the Paperwork Reduction Act ( PRA) at 44 United States Code section 3502( 11), i. e., " the term ` practical utility' means the ability of an agency to use information, particularly the capability to process such information in a timely and useful fashion." OMB's regulatory definition of " practical utility" at 5 CFR Part 1320.3( l) addresses not only the theoretical or potential usefulness of information to an Agency, but its actual usefulness,

taking into account its accuracy, validity, adequacy, and reliability, and the Agency's ability to process the information in a useful and timely fashion, and taking into account whether the Agency demonstrates actual timely use of the data either by the Agency to carry out the Agency's own functions or by third parties.

The Agency had ensured that the data will be accurate, valid, adequate, and reliable, as needed for screening level data. EPA considered the types of information needed for screeninglevel exposure and risk assessments and believes the information collected through the IURA will have the necessary level of adequacy, accuracy, validity, and reliability for such assessments. In developing the IURA and considering various alternatives, EPA relied on experience from programs such as TSCA's PMN program and the UEIP data collection. EPA also maintained a balance between data needs for exposure screening and the burden associated with providing the information. If the Agency had required very precise, specific reporting, company burden would Page 12 of 159 have increased beyond that which is appropriate for a screening level data collection. There are many factors that can affect exposure potential. The data provided by the submitters will provide baseline information sufficient for an initial screen of exposure potential.

EPA ensured the adequacy of the data that will be collected under IURA by analyzing the usefulness of the data elements covered by various exposure data collections and assessments to determine the data elements most needed for a screening level exposure assessment. This discussion and analysis is in the document " Inventory Update Rule ( IUR) Amendment Technical Support Document: Exposure Related Data Useful for Chemical Risk Screening" ( Ref. 16).

Commenters' suggestions implied that more extensive information about exposures would be necessary for even a screening level analysis of potential exposure. As summarized in Unit III. A. 1. of the Final Rule preamble, risk analyses performed by the Agency in general and OPPT in particular are graduated and data driven. As the initial levels of concern and the quantity and quality of data increase, the need for and methodologies used in risk review become more detailed and exacting, while the reviews become more accurate and reliable. Based on its experience assessing chemical risks through such programs as the TSCA New Chemicals Program, the Agency believes the IURA data will provide information adequate to perform initial screens of chemicals, and to prioritize and make basic risk management decisions about those chemicals of greatest concern as indicated by the available data. These better informed decisions will enhance confidence that the most appropriate chemicals are selected for more detailed assessments.

The Agency considered the data accuracy and reliability needed for screening level exposure analyses and took several steps to ensure the IURA data meet those needs. Screening level data need not be absolutely precise, but should be accurate and reliable enough to make usable and defensible technical assessments. The IURA will supply exposure related information the Agency does not currently have, recognizing that industry has a greater knowledge than EPA about its own operations and the uses of chemicals it manufactures and sells. Without this information, EPA either would not screen these chemicals, would screen them using outdated or anecdotal exposure information, or would rely on exposure estimates ( which are typically conservative) using modeling data.

Much of the IURA information will be submitted to EPA within specified ranges, rather than as discrete figures. This requirement benefits both the Agency and submitters. First, range reporting is less burdensome for the submitter than calculating specific quantity estimates.

Demanding greater data precision increases the burdens associated with data collection. Second,

information reported in discrete numeric values can indicate a precise level that is not necessarily present. By specifying ranges, a higher level of confidence in the data accuracy is attained. Page 13 of 159 EPA's experience with similar data collecting efforts such as under the TSCA New Chemicals Program demonstrates that the type of data EPA will collect under IURA are sufficient for the purpose of screening to prioritize follow on efforts for risk assessment and management.

As discussed in Unit III. A. of the final rule preamble, EPA exposure and risk evaluations are typically tiered and data dependent: the level of detail in the assessment is directly proportional to the quantity and quality of the available data, while the level of uncertainty is inversely proportional to those factors. IURA data will be useful to the Agency in evaluating potential exposures and risks, serving as indicators as to what exposures from what chemicals need greater review and possible attention.

Comment A. 1 4: One commenter stated EPA should address the competing demands of government and private resources, laboratory capacity, scientific and information capabilities, and animal welfare.

Source: C1 033 Response A. 1 4: EPA is concerned about the various competing demands, as suggested by the commenter. During the development of the IURA, EPA took into consideration the demands of government and private resources by working to balance the Agency's need for screening level exposure information with the burden imposed on industry. In order to keep the burden associated with reporting low, EPA raised the initial reporting threshold from 10,000 lbs.

to 25,000 lbs. and instituted a second reporting threshold of 300,000 lbs, rather than its preferred second reporting threshold of 100,000 lbs. These changes result in fewer submissions and,

therefore, lower burden than if these changes were not implemented. EPA also is requiring reporting for much of the new, exposure related information at a " readily obtainable" standard and in ranges. The " readily obtainable" standard involves less effort than is required for the reporting of other IUR information, which is subject to the " reasonably ascertainable" standard ( see Unit III. D. 2. of the final rule preamble for more information). All of these additions to the IUR were devised in an effort to reduce the reporting burden associated with the IURA.

The Agency plans to use the IURA information to better target Agency programs,

resulting in more targeted requirements for the use of labs, conducting testing, or gathering additional information. Furthermore, as the development of IURA information will not involve the use of any animals and will not involve conducting any testing, neither animal welfare nor laboratory capacity concerns are implicated. Page 14 of 159 Comment A. 1 5: EPA is using volume as a surrogate for risk in setting priorities.

Source: C1 043 Response A. 1 5: Under IUR ( and IURA), production volume determines which chemicals must be reported by a given site and which do not. EPA recognizes that some chemicals produced in volumes below 25,000 lbs. may have hazards high enough that the potential risk is of sufficient level to require additional attention and there may be a need for additional processing and use information on chemicals produced in volumes below 300,000 lbs.

However, EPA also recognizes that a cutoff has to be made at some point.

While past approaches to priority setting have been primarily based on relative chemical hazards and production volume as a simple surrogate for exposure, EPA has increased its emphasis on the exposure component of risk screening and assessment. As a result, through IURA, EPA is attempting to reduce its reliance upon production volume as a surrogate for exposure, and will instead gather data that will allow the Agency and others to make more accurate and realistic estimates of exposure. The exposure related information reported under the IURA, in combination with hazard information such as that developed under TSCA section 4 test rules and enforceable consent agreements, or through voluntary efforts such as the HPV Challenge Program, will allow the Agency to more effectively screen and prioritize chemicals based on potential risk. By collecting the exposure related data included in the IURA, the Agency will have access to information that will greatly improve EPA's ability to identify, through risk screening, certain chemical substances that could pose a risk to human health or to the environment.

2. Ability to Use the Data Comment A. 2 1: Many commenters state that EPA could not begin to make effective and timely use of even a small portion of the IURA processing and use information for 4,000 chemicals. Commenters indicated that the large amount of data submitted would overwhelm the Agency, even though EPA acknowledges that its ability to utilize the information is critical to realizing any benefits from the proposed IURA. Commenters stated that EPA did not explain how its programs and resources would be able to analyze and use the vast amount of information that would be reported under the rule in a meaningful time frame. Several commenters suggested that a more limited program be used as a first step. Page 15 of 159 Source: C1 002, C1 007, C1 009, C1 010, C1 011, C1 013, C1 016, C1 017, C1 018,

C1 019, C1 021, C1 024, C1 027, C1 032, C1 033, C1 038, C1 042, C1 046, C1 055 Response A. 2 1: EPA acknowledges that the IURA will generate a significant quantity of new data that EPA has not handled under past IUR data collections. However, EPA has carefully designed the IURA data collection to facilitate efficient data management and data use. Data collected through IURA will be put into a relational database format, which can be easily searched, compared, and used. The collection of specific data, organized by codes, instead of textural information presented in a unstructured manner, lends itself to such a database format. In addition, electronic IURA submissions allow data to be entered into the database accurately and expeditiously, resulting in a quick turnaround between the submission of the data to the Agency and the availability of the data for use. The Agency anticipates that approximately 95% of all reports will be submitted electronically or on disks, as opposed to hard copy submissions. In 1998, about 70% of submissions were on disks. The IURA will facilitate EPA's information management and data will be quickly available for the Agency's use.

EPA intends to use the IURA data, including the processing and use data. These data will serve a vital function in many Agency programs and activities. However, the Agency does not plan to conduct a full risk analysis for each and every chemical. EPA will use the data to determine, on a relative basis, which chemicals will result in potentially higher exposures or, when combined with hazard data, risks and thus merit further assessment. EPA has carefully designed the IURA data collection to facilitate efficient data management and use.

Comment A. 2 2: Commenters mentioned a GAO report which stated " we continue to question the need for, and EPA's ability, to effectively manage and utilize data on as many as 12,000 substances." One commenter stated that EPA misinterpreted the GAO report it is using to support the proposal.

Source: C1 032, C1 042 Response A. 2 2: EPA considered the 1995 GAO report (" EPA Should Focus Its Chemical Use Inventory on Suspected Harmful Substances,'' ref. 17) when developing the IURA. EPA has done what the GAO report recommended, which is to limit use reporting to several thousand chemicals. GAO's conclusion in the 1995 report reads:

" In our opinion, implementing the inventory on a smaller scale than currently envisioned Page 16 of 159 by EPA, initially covering possibly as many as several thousand of the chemicals suspected to present the greatest risk, would provide key data on chemical use and exposure while limiting the reporting burden on the chemical industry and EPA's data management requirements. This approach would also give EPA the opportunity to assess the data obtained, reconsider the chemicals and type of data included in the inventory, and make any necessary adjustments to its approach."

EPA does not believe that it misinterpreted the GAO report in developing the IURA. By limiting the chemicals for which downstream exposure related data will be reported to 4,000 in the first year and 4,600 in reporting periods that include full reporting for inorganics, EPA has ensured that IURA is consistent with recommendations from the GAO report.

Comment A. 2 3: One commenter stated that the information collected would be useless without toxicity data. Another commenter stated that EPA does not explain how it will conduct risk screens when it may not have toxicity data and there is no working process in place to conduct the screens.

Source: C1 010, C1 032, C1 071 Response A. 2 3: Risk is composed of both exposure and hazard, or toxicity. A risk screen cannot be conducted without both exposure related data and hazard related data. To date,

the Agency has used many techniques to determine whether to collect exposure related or hazardrelated data on a particular chemical. For instance, the HPV Challenge Program used production volume as a proxy for an initial exposure screen to determine which chemicals to include in the program, which collects screening level toxicity information on high volume chemicals. A large portion of the IURA chemicals fit within the parameters of the chemicals included in the HPV Challenge, and EPA will therefore have both exposure and hazard information for those chemicals. In addition to the HPV Challenge, there are a variety of processes in place to collect needed hazard information, including TSCA section 4 test rules, enforceable consent agreements,

and other voluntary efforts.

However, EPA will also use the IURA exposure related data to conduct exposure screens as well as risk screens, and will use the information in a variety of other uses ( see comment response A. 2 1 for a discussion of additional uses). The exposure information will also be used to evaluate which chemicals warrant the development of toxicity information through other EPA programs. Page 17 of 159 Comment A. 2 4: One commenter stated that EPA would collect massive amounts of exposure data each reporting cycle under IURA. Furthermore, the commenter stated that by the time the Agency were to complete its preliminary risk analyses based on the massive volume of data it collects, many of the chemicals on which data were collected that were formerly produced at high volumes, would no longer be produced at high volumes meaning that they would be lower risk chemicals. The commenter believes this results from the inherent variability of chemical production volumes from year to year, coupled with the length of time that would be needed to review the large amount of data that would be generated every four years under the proposed IURA.

Source: C1 024 Response A. 2 4: The variability of the chemical industry  the fact that production volumes can vary significantly from year to year and that chemicals go in and out of production and markets  is a compelling fact supporting the collection of IURA information. EPA's experience with past IUR reporting demonstrates that there is a 30% change in the chemicals reporting from one reporting period to the next. The Agency considered collecting this information every two years, with the expectation that more frequent collection of information would allow earlier identification of potential exposure concerns and significant trends in the chemical industry. However, EPA recognizes the need to keep within the spirit of the PRA and to keep the public reporting burden as minimal as possible. While the final rule indicates that subsequent reporting years and submission periods will occur every four years, in a separate action following the final rule, EPA intends to change the reporting frequency after the first reporting year under IURA ( i. e., 2005, with submission to EPA in 2006) from every four years to every five years. This will be accompanied by a change to the recordkeeping requirement,

extending the record retention period to six years.

As described in the response to comment A. 2 1, the data collection is designed to facilitate efficient data management and use, allowing EPA to fully utilize the IURA data.

3. Other Sources of Data and Methods of Collecting Data Comment A. 3 1: Commenters suggested using PAIR to collect chemical specific data instead of amending the IUR. A commenter stated that EPA developed PAIR for the purpose of obtaining exposure information on chemicals of concern to the Agency ( 4A See 47 Fed. Reg. Page 18 of 159 26992 ( June 22, 1982)). This commenter felt that the PAIR rule is a more rational tool to use because it was promulgated for the specific purpose of gathering exposure information on defined groups of chemicals, whereas the IUR was promulgated for the purpose of gathering production information on virtually all chemicals listed on the TSCA Inventory. Another commenter stated that EPA could use PAIR to collect information on a chemical when " there is concern that a particular chemical's exposure or use profile may have changed in a manner that has risk implications, and where EPA is prepared to review the risk of that chemical." This commenter stated that PAIR could be revised to collect the use information by consumer groups and NAICS codes, which are currently not part of the PAIR form. EPA could also modify the PAIR rule to require periodic reporting.

Source: C1 016, C1 024, C1 055, C1 068 Response A. 3 1: EPA believes it is more appropriate to amend the IUR than PAIR for purposes of collecting basic exposure information on the portion of the TSCA Inventory covered by IURA reporting.

IUR was not promulgated for the purpose of gathering production information on virtually all of the chemicals listed on the TSCA Inventory. The current IUR collects information on approximately 9,000 chemicals out of the more than 76,000 chemicals listed on the TSCA Inventory B approximately 12% of the TSCA Inventory. Additionally, as further explained in preamble to the final rule ( Unit II. B.), the Agency is well within its authority to collect exposurerelated information using the IUR.

Information collected through IURA is designed to feed directly into a database, allowing users of the information to readily search that data, as described in the response to comment A. 2

1. PAIR information is not provided in a manner which can readily feed into an easily searchable database. The Agency needs this exposure information in a database, enabling the information to be used in a wide variety of applications for a wide variety of uses. Selective use of PAIR, as the commenters suggest, would not address the lack of exposure information EPA currently faces.

Using only PAIR implies that EPA should continue to set risk screening priorities based on hazard and production volume alone. As discussed in the document titled " A Review of Existing Exposure Related Data Sources and Approaches to Screening Chemicals: A Response To CMA,"

this approach greatly hinders EPA's ability to make effective and efficient risk management decisions. Page 19 of 159 Comment A. 3 2: Many commenters stated that EPA has not made effective use of the use and exposure data it has already collected under existing or former rules. For example, they stated that data collected under two other TSCA rules C the PAIR and the Comprehensive Assessment Information Rule ( CAIR) rules C have not been effectively used to support Agency risk assessment or risk management decisions. They went on further to say that under the voluntary Use and Exposure Information Project ( UEIP), EPA was furnished exposure related data on 60 HPV chemicals, but only two made it into the RM 1 process. Commenters also stated that EPA should rely on data in sources that are already existing, such as those described in CMA's ( now ACC) document " U. S. Chemical Production, Use and Exposure Data; A Study of Existing Information Sources" ( August 1, 1997). Specifically, commenters mentioned sources such as the Use Cluster Scoring System ( UCSS), the Toxics Release Inventory ( TRI), the Biennial Reporting System ( BRS), the Screening Information Data Set ( SIDS), Material Safety Data Sheets ( MSDS), and information in EPA's own library system and the public library system.

Source: C1 007, C1 009, C1 010, C1 011, C1 014, C1 016, C1 017, C1 018, C1 019,

C1 021, C1 023, C1 024, C1 027, C1 031, C1 032, C1 033, C1 035, C1 037, C1 038,

C1 041, C1 042, C1 044, C1 046, C1 048, C1 055, C1 060, C1 065, C1 071, C1 073 Response A. 3 2: The Agency and others have used data collected under existing or former rules or though voluntary programs. For instance, data previously collected have been used to screen chemicals to determine if further assessment or actions is needed. PAIR data have been used to inform Agency test rule development and to inform Interagency Testing Committee ( TSCA sec. 4( e)) recommendations. CAIR data were collected over 15 years ago; as the CAIR rule was revoked, it can no longer be used to collect current exposure related data; it is important to have current exposure related data since, unlike hazard data, exposure related data changes over time. Data collected through the UEIP have been summarized in either an exposure profile report or a data summary report, depending on the amount of data EPA received. The reports are being used to prepare preliminary risk assessments, or risk management level 1 ( RM1) reports and, through OECD efforts, to prepare SIDS Initial Assessment Reports, or SIARs. The SIARs are then used to reach risk management decisions concerning each chemical.

The alternate data sources commenters described were sources that EPA had already evaluated in its analysis for the proposed rule. EPA explored a wide variety of public data sources, as demonstrated by: " Inventory Update Rule ( IUR) Amendments Technical Support Page 20 of 159 Document: Exposure Related Data Useful for Chemical Risk Screening," " Economic Analysis of Proposed Amendments to the TSCA Section 8 Inventory Update Rule," and " A Review of Existing Exposure Related Data Sources and Approaches to Screening Chemicals: A Response to CMA" ( Refs. 14, 16, and 17). Commenters did not provide EPA with new or additional support for these alternate data sources. The Agency's support documents confirm that these alternate data sources do not provide adequate information to meet the needs EPA envisions the IURA information will satisfy.

EPA spent considerable effort and resources evaluating other data sources that could potentially provide the accurate and up to date information that the Agency needs to meet its mandate of protecting human health and the environment. A primary consideration, as mandated by TSCA, was to avoid unnecessary or duplicative reporting. As summarized in the proposal, the exposure information sought using the IURA is not currently available. Although some useful exposure related data exist in several sources, the data are outdated, lack detail, do not cover the scope of chemicals that will be covered under IURA, or do not cover the data elements that will be covered under IURA. As a result, EPA remains unable to efficiently screen potential risks posed by the large number of chemicals on the TSCA Inventory. In addition, EPA may at times identify? potential new hazards that must be considered such as endocrine disruption and hazards related to children's health. It is important to link these new hazards with potential for exposure.

Although exposure related information has been collected under certain regulatory and voluntary programs in the past, there is a need for current exposure related information on a relatively broad based set of chemicals. Additionally, EPA plans to continue using existing data sources and information sets. However, the existing sources are best used for conducting assessments of specific chemicals of concern, depending upon the data actually available. Data from public sources is not sufficient for the preliminary risk screening of a large set of chemicals.

The IURA submissions will provide an extensive set of exposure data that will allow EPA to better identify on a relative basis the chemicals of highest priority for further risk evaluation. EPA will use the IURA data, as described in the response to comments A. 1 1 and A. 1 2, to identify those specific chemicals which are of potential concern and need follow up assessment. For instance, the IURA exposure data coupled with the HPV Challenge Program screening level hazard data will provide the input needed to effectively develop program priorities for follow up assessment of chemicals in the HPV Challenge Program. Once EPA has determined that a specific chemical ( or group of chemicals) has sufficient potential for exposure to warrant further assessment, the Agency will utilize the other information sources and data gathering tools as appropriate. Page 21 of 159 Comment A. 3 3: One commenter stated that, while EPA has developed exposure profiles from information collected through PAIR and CAIR data, the voluntary industry effort to provide data under the UEIP, and data available under the OECD SIDS program, the Agency has chosen not to make use of the information. The exposure profiles are not likely to have changed significantly since the information was first provided, and an " update" of this information through the IUR is not an effective use of either the industry's or EPA's resources. Additionally, EPA could amend CAIR, as planned when the Agency revoked it in 1995.

Source: C1 016, C1 033 Response A. 3 3: EPA has made use of the data collected through the various sources listed by the commenters, as described in response A. 3 2 above. EPA plans to continue using existing data sources and information sets. However, the existing sources are best used when one is assessing specific chemicals due to the type of information available and the format of the information. For instance, a source might have somewhat detailed information on a specific chemical, and enclose that information in paragraph format. In contrast, the IURA information will be in a readily searchable database, from which information can be searched based on specific criteria and the results downloaded into various models. EPA will use the IURA data to identify those specific chemicals. Once EPA has determined that a specific chemical ( or group of chemicals) has sufficient potential for exposure or risk to warrant further assessment, EPA will utilize the other information sources and data gathering tools on an as needed basis.

EPA has used the information on occupational exposure submitted in response to previous rules. Under the voluntary UEIP, data were submitted on only 48 of the 60 chemicals for which information was solicited. The data submitted on 13 of the UEIP chemicals were insufficient to prepare data summaries; the Agency summarized this information for future reference. For the 35 chemicals for which adequate information was received, an exposure profile or a data summary report was prepared. The exposure profiles have been used to prepare preliminary risk assessments for six chemicals; an additional twelve risk assessment reports are in preparation.

The preliminary risk assessments have been used to support risk management decisions including test rules and product restrictions.

UEIP data have also been used in the development of Screening Information Data Set ( SIDS) reports by the Organization for Economic Cooperation and Development ( OECD). To date, OECD has prepared Screening Information Assessment Reports ( SIARs) for 111 chemicals.

For those chemicals for which OECD has completed the SIDS, the Agency will use the SIDS and Page 22 of 159 the SIAR in preparing its own risk assessment.

The Agency agrees that the exposure profile for a chemical may not change if the processes used to produce the chemical and the uses of the chemical remain the same. However,

over time new uses for existing chemicals may develop and the quantity directed to different uses may change over time. Because new uses for existing chemicals may be found and past data collection efforts such as the UEIP and CAIR have not provided information on a relatively broad based set of chemicals existing at the time of the voluntary program or rule, a new effort is needed to assemble this information in a format readily usable by EPA. This is one objective of the IURA.

CAIR is not a suitable substitute for the IURA. In order to collect information through CAIR, a regulation which has been revoked, the Agency published a specific list of chemicals subject to the rule. To use CAIR, EPA needed to identify, upfront, the specific chemicals of current interest and the specific data elements of interest. In contrast, the IURA data collection was designed to allow the Agency and others to proactively identify chemicals of concern by providing the data needed to complete an initial screening based on exposure or, with the addition of hazard information, on risk. Additionally, past IUR data demonstrates that the chemical industry is dynamic; there has been a change of 30% in the chemicals reported from one reporting period to the next.

This experience with past IUR data also demonstrates that exposure scenarios are expected to change over time; as chemical production volumes change, it's expected that uses or other aspects of the exposure scenario are likely to change as well.

Comment A. 3 4: Commenters suggested EPA use voluntary methods to collect the exposure related data sought by the IURA. A commenter suggested EPA build on the " positive experience with the UEIP program." Another commenter suggested using voluntary reporting in connection with the ICCA HPV program, using the SIAR format to collect exposure information.

Additionally, commenters suggested using other voluntarily provided information, such as that to be provided through the HPV Challenge Program and the Voluntary Children's Chemical Evaluation Program ( VCCEP).

Source: C1 017, C1 032, C1 033 Response A. 3 4: EPA considered using voluntary reporting as a way to collect the processing and use information that will be collected using the IURA, but determined that Page 23 of 159 voluntary reporting would not provide information sufficient to meet the needs the IURA is designed to satisfy. As described in Units II. E., III. A. 1, and III. A. 2. a. ii. of the final rule preamble,

voluntary programs are not uniformly reliable for collecting data, and the Agency generally cannot ensure that data submitted under voluntary efforts will be complete and accurate. For example,

the UEIP was undertaken by EPA in partnership with industry to collect relatively detailed information on 60 high production volume chemicals. EPA received data for 48 of the 60 UEIP chemicals. Many of the forms received for those 48 chemicals were not completely filled out, and only a subset of manufacturers submitted data. Thus, while the information that EPA received was quite useful, it was insufficiently complete for the purposes to which IURA information will be put. Additionally, as described in the response to comment A. 1 3, the Agency designed the IURA data collection to meet data standards needed for preliminary screening of TSCA Inventory chemicals. Based in part upon EPA's experience with information provided through the UEIP,

the limitations of the data available from past and current information collections that are described in detail in the IURA proposal ( 64 FR 46772, August 26,1999), and the amount of time it would otherwise take to acquire screening level exposure data for the chemical substances on the TSCA Inventory, it is appropriate to develop a more systematic and broadly applied approach to the prioritization process. The Agency is doing this by requiring that certain basic exposure related information be reported under this amended rule instead of collecting the information through a one time voluntary program. EPA plans to continue using voluntary methods to collect data specific to certain programs, either to collect information on chemicals not reporting under IURA or to collect more detailed information.

It was also suggested that the Agency use the SIAR format to collect exposure information in connection with voluntary programs ( e. g. via ICCA HPV Program). As stated above, EPA's experience with voluntary programs ( e. g. UEIP) will not be sufficient for EPA's purposes. Furthermore, EPA's experience with the OECD SIDS program indicates that a majority of SIARs contain very limited exposure information since the focus is on hazard. The quality of information also varies among the SIARs since submission of exposure information is voluntary. Some contain detailed exposure information while others lack many of the data elements being collected under IURA such as maximum concentration and number of workers potentially exposed.

The Agency recognizes that many voluntary and regulatory efforts to collect health and environmental hazard data are underway, and that a premier effort is the HPV Challenge Program. However, the scope and expected output from the HPV Challenge Program markedly differ from those anticipated under IURA. The HPV Challenge Program centers on providing Page 24 of 159 hazard data for a limited set of HPV chemicals, whereas the focus of IURA is on gathering exposure related information for chemicals in a wide range of industrial, commercial, and consumer operations, including both manufacturing and downstream applications. The commenter also suggested VCCEP as a tool to collect part of the IURA information. As with the HPV Challenge Program, the scope and expected output from VCCEP differ from those anticipated under IURA, and any exposure related information collected through VCCEP will focus on children's exposures. In addition to the other concerns mentioned earlier with collected IURA type information through a voluntary program, VCCEP information would likely be too narrow to meet the needs of the IURA, even for those chemicals included in the VCCEP pilot.

Comment A. 3 5: Commenters suggested that EPA could use the National Institute of Occupational Safety and Health ( NIOSH) as a source for exposure related data. Commenters specifically mentioned NIOSH's National Occupational Exposure Survey ( NOES) and stated that it would be far more effective and less burdensome to industry to update this survey than to attempt to gather the information on IUR forms. One commenter stated that EPA has not used the NOES survey data. Another commenter stated that the NOES data are not outdated and that historical data can be used to identify particular chemicals for which more data is needed. A comment from NIOSH stated " NIOSH is in the process of planning another hazard survey similar to the National Occupational Hazard Survey ( NOHS) and the NOES. Enhancements are planned in the next survey, including expanding the scope of industries and hazards to be surveyed.

NIOSH views the data collected from the proposed IUR updated rule and the NIOSH survey data as complementary."

Source: C1 013, C1 040, C1 065 Response A. 3 5: EPA has used the NOES data extensively in its exposure assessments for well over 10 years. For each existing chemical assessment, whether it has been in support of a risk management level 1( RM1) decision, test rule, Design for the Environment` s Cleaner Technologies Substitute Assessment, or other type, the NOES database has been searched for that existing chemical, and when data are present in the NOES, those data have been included in the assessment.

As described in the proposed rule preamble ( 64 FR 46780, August 26,1999), NIOSH's NOES and EPA's IURA data collections have significantly differing scopes and approaches. For instance, the NOES collection focused on worker issues, whereas IURA includes consumer and Page 25 of 159 commercial information as well as manufacturing and industrial processing. The NOES collection also does not include concentration of the chemical processing and use information, or the percent production volume for various uses. These are key data elements for determining the magnitude of potential exposure. Therefore, EPA collaboration in the NOES updating process cannot fulfill the needs EPA intends to satisfy via IURA. EPA agrees with NIOSH that the data collected by the IURA and the new NIOSH are complementary rather than duplicative.

Although a valuable data source, use of the NIOSH NOES data for EPA's purposes has become increasing difficult. This is due to factors such as the age of data ( the survey was completed in 1983 and is now almost 20 years old), and the uncertainty in extrapolation from the small sample of facilities surveyed to make national estimates of exposure. While NIOSH is developing a new survey, it will initially focus on specific industries such as the health services sector and on certain classes of chemical agents, such as antineoplastics and high level disinfectants. NIOSH's new survey will probably begin in 2004 ( Ref 18). As with NOES, EPA will find information from NIOSH's new survey useful, but it is not expected to serve as a replacement for IURA.

Comment A. 3 6: Several commenters thought OSHA should be responsible for collecting exposure information rather than EPA. One commenter stated that EPA should rely on existing government agencies ( OSHA) whose experience is in exposure rather than develop duplicative,

separate and possibly inconsistent or misleading databases. Another commenter stated OSHA is the preeminent federal agency with the responsibility for protecting workers and, therefore,

OSHA's chemical exposure standards should be used as the threshold for triggering exposure reporting under the IUR. In addition, some commenters noted that OSHA and other agencies have their own authorities to use as appropriate. Some commenters felt that, under TSCA, EPA must defer to other statutes that address the same concerns.

Source: C1 013, C1 015, C1 019, C1 020, C1 042 Response A. 3 6: EPA believes that the data collected by the IURA will complement data collected by OSHA, not be duplicative of OSHA's data. EPA, OSHA, and other Federal Agencies do share information, and information collected by OSHA was considered when EPA developed the IURA. For instance, OSHA, NIOSH, and EPA meet regularly ( in ONE committee meetings) to discuss activities of mutual interest; the IURA was discussed during these meetings.

Additionally, OSHA provided review and comment as the rule was developed. OSHA submitted Page 26 of 159 several letters in support of the IURA, all of which are in the public record for this rulemaking.

OSHA's authority to implement the general duty clause and to develop industry standards based upon substantial evidence of hazard to employees is distinct from EPA's authority to collect information under TSCA. The authority of EPA to maintain and update the TSCA inventory of chemical substances is derived from sections 8( a) and 8( b) of TSCA. Section 8( a)( 2)( F) of TSCA ( 15 U. S. C. 2607( a)( 2)( F)) permits EPA to require maintenance of records and reporting of " the number of individuals exposed, and reasonable estimates of the number who will be exposed,

to such substances or mixtures in their places of employment and the duration of such exposures."

OSHA has traditionally developed rules for limiting workplace exposure to chemical substances one chemical at a time. Updating the TSCA inventory of over 76,000 chemicals by individual rules for each chemical is not practical.

TSCA embodies the policy of Congress to develop adequate data on the effect of chemical substances and mixtures on health and the environment ( TSCA § 2). TSCA seeks to develop information through test rules ( TSCA § 4), review of premanufacture notification requirements for new chemicals ( TSCA § 5), and collection and compilation of information on chemical substances ( TSCA § 8). Although other statues may include clauses similar to the authority given to EPA to regulate chemicals under TSCA, this does not preclude EPA from exercising its full authority under TSCA. For example, the objectives of TSCA and the OSH Act are complimentary in protecting worker health, but the authority under TSCA is much broader in allowing EPA to collect and utilize information about chemical hazards to protect not only employees but also public health and the environment.

TSCA does not limit use of data collected under the statute to EPA. EPA believes Congress drafted TSCA in part to provide basic health and safety information to other federal agencies, as well as state, local and international governments. TSCA provides several mechanisms, TSCA § § 9, 10 and 12 for example, for sharing health and safety data among various levels of government. These sections again demonstrate TSCA's role as a tool for gathering and disseminating information regarding chemical risk.

TSCA section 8( a)( 1) authorizes the EPA to promulgate rules under which manufacturers and importers of chemical substances must maintain such records and submit such information as the Agency may reasonably require. Under TSCA section 8( a), the Agency may collect information to the extent that it is known to, or reasonably ascertainable by, the submitter, on the manufacture ( including import) and processing of chemical substances. This section gives EPA broad discretion in determining the information for which reporting can be required. Some of the types of information which can be required under TSCA section 8( a)( 2) include: categories of use Page 27 of 159 for each chemical substance, estimates of the amount manufactured or processed for each category of use, a description of the byproducts resulting from the manufacture, processing, use,

or disposal of each chemical substance, an estimate of the number of individuals exposed in their places of employment, and the duration of such exposure.

OSHA has established regulations for protection of employees in the workplace from respiratory contaminants for which a OSHA Permissible Exposure Limit ( PEL) has been promulgated ( 29CFR 1910.134). OSHA PELs exist for only a few thousand chemical substances;

the majority of the over 76,000 chemicals on the TSCA inventory subject to the IURA are not regulated by the respiratory protection standard and, without the IURA, potential exposure to these chemicals would never be reported. In addition, the OSHA respiratory protection standard pertains only to respiratory hazards; relying on this standard to trigger reporting would miss chemical substances which are hazardous if ingested, deposited on the skin, or which enter the body through the eye.

Comment A. 3 7: The Chemical Manufacturers Association ( CMA) ( now the American Chemical Society) completed a pilot study to assess publicly available exposure information for five chemicals. CMA chose these five chemicals because they are in the SIDS program, are considered HPVs, and fit the objectives of ongoing assessment programs. CMA's data search methodology revealed that use and exposure information do not generally appear in the same data sources. From their study, CMA concluded that data sufficient to conduct a risk screen are available. Additionally, CMA believes that the available data are more extensive than that required under the IURA.

Source: C1 018, C1 033, C1 055 Response A. 3 7: CMA attempted to demonstrate the usefulness of the existing data sources through its study of five chemicals. However, CMA did not demonstrate that these data sources could satisfy the needs the IURA is designed to address, as described in the responses to comments A. 1 1, A. 1 2, and A. 1 3. In fact, the CMA study highlighted the insufficiency of existing use and exposure information as it relates to the data to be collected through IURA,

which seeks to collect use and exposure data elements along with identifiers ( NAICS, code,

Industrial Function Code, etc.) that will allow the Agency to compile and analyze the data in a way that is both efficient and useful for risk screening, as well as for other purposes. Collecting and assembling use and exposure data in a way that the CMA study suggests would create an Page 28 of 159 extremely uneven database of information from various sources with varying degrees of data elements, quality, and age. In contrast, IURA information will be used to create a shallow pool of data for a broad set of chemicals; the data will cover a similar time period, will be collected under similar circumstances, and will be in a format readily applicable to a database. CMA seems to suggest that the data available for five selectively determined chemicals is indicative of the availability of use and exposure data for a majority of the IURA chemical substances. EPA disagrees with this suggestion, as demonstrated in " U. S. Chemical Production, Use, and Exposure Data: A Study of Existing Information Sources." ( Ref 19). Rather, CMA demonstrated that certain data did exist for chemicals that are currently under assessment. EPA does not dispute this. However, EPA finds a need to collect IURA information on these and other chemicals currently under assessment in order to track future potential exposures, changes in the uses and production of these chemicals, and to maintain an updated TSCA Inventory.

Comment A. 3 8: A commenter stated that sufficient information is readily available under the data submitted through the TRI reporting requirements. Another commenter stated that EPA underestimated the amount of data currently being reported under the TRI, pursuant to Section 313 of the Emergency Planning/ Community Right to Know Act ( EPCRA). This commenter states " In the face of the TRI database alone  over 32,000 reporting facilities filing more than 137,000 reports annually, with 5,100 more facilities and 15,000 more reports likely to be added in the next year  it is difficult to understand the need to impose additional, sweeping reporting requirements on a broad swath of American industry that is already subject to extensive reporting requirements."

Source: C1 014, C1 019 Response A. 3 8: Sufficient data to serve the purposes of IURA data is not available through TRI; IURA data and TRI data do not overlap. TRI reporting serves a very different purpose than IURA reporting. TRI does not collect the same data that will be collected under IURA, focusing instead on release data from manufacturers, processors, and users in specific industrial sectors manufacturing or using any of approximately 600 chemicals. In contrast, IURA collects very different information, including downstream use and exposure related information as well as manufacturing information on approximately 9,000 chemicals from the over 76,000 listed on the TSCA Inventory. IURA data will allow the Agency and others to screen for potential exposures to chemicals from sources other than the specific, known release information collected Page 29 of 159 under TRI.

4. Rule Development Process Comment A. 4 1: It appears that the data that EPA relied upon to develop this rule were outdated. Many references that are cited in the references for the technical support document on commercial and consumer categories are approaching 20 years old and include outdated use scenarios. In addition, EPA's analysis of potential industrial function categories was based on SIC Codes yet EPA is requiring reporting under the more appropriate NAICS codes which indicate that EPA has failed to update it own analyses.

Source: C1 033, C1 073 Response A. 4 1: During the development of this rule, EPA used the best technical references available and based the development of the industrial and commercial/ consumer function categories on information from the PMN Program, UCSS, UEIP, and EU programs, as well as other data. EPA recognizes that use scenarios may change over time. In the preamble to the IURA proposal, EPA states that the industrial and commercial/ consumer function categories " are likely to be revised as analysis of reported IUR data is further refined over time" ( 64 FR 46771, 46790).

The Standard Industrial Classification ( SIC) system was the most current industrial classification source during the development of this rule. Even today, information is still collected using the SIC classification system. Tables do exist to crosslink the SIC system with the NAICS system, which was published in Spring of 1998. EPA believes the results for the function categories would not change if the analysis used to determine those categories was redone using the NAICS codes. The NAICS is based on many of the old SIC industrial sectors. For instance,

the SIC system had 10 industrial sectors and the NAICS expanded those industrial sectors into 20. Careful review of the crosswalks between the NAICS and SIC systems reveals that many of the NAICS industrial sectors contain only modest changes from the original SIC sector ( e. g.,

manufacturing went from 459 industries under SIC to 474 industries under NAICS). In addition,

NAICS has strong agreement with the SIC system at the 2 digit level. EPA is requiring submitters to report under the NAICS because it reflects the current universe of industries.

5. Right to Know Comments Page 30 of 159 Comment A. 5 1: Many commenters disagreed with EPA's characterization of TSCA as a right to know statute, stating that the objective of the IURA " to provide ` right to know'

information to non governmental entities and private organizations... is not authorized by TSCA."

Some commenters felt that EPA was trying to unlawfully shift the burden by using TSCA to expand TRI reporting requirements.

Source: C1 007, C1 011, C1 019, C1 032, C1 033, C1 038, C1 043, C1 055, C1 069,

C1 073 Response A. 5 1: TSCA contains many of the principals embodied in the right to know concept and does authorize the Agency to provide information to the public. TSCA was designed in part to address the lack of health and safety information government agencies and the public faced in dealing with chemicals. See, H. R. Rep. 94 1341 at 6 ( 1976), reprinted in Legislative History of the Toxic Substances Control Act, at 414 ( 1976) (" Present authorities for protecting against and regulating hazardous chemicals are fragmented and inadequate . . . Most significant among the deficiencies are . . . ( 3) No authority exists for collection of data to determine the totality of human and environmental exposure to chemicals."). TSCA was seen as a way of providing agencies and the public with better health and safety data so that the risks of chemical substances could be more fully evaluated and understood. See, Statement of Sen. Hartke, Cong.

Rec., March 26, 1976 [ S4397 4432], reprinted in Legislative History of the Toxic Substances Control Act, at 218 ( 1976) ("[ T] he essential element of this legislation is that it has attempted to provide for the individual not only who works, but for the rest of American society the right to know what is in store as far as the toxicity of the chemicals is concerned." Thus, Congress clearly envisioned TSCA as a method of providing the public and others with health and safety information about chemical substances.

In addition, TSCA authorizes EPA in a number of sections to disclose health and safety data to the public. For example, TSCA § 14( b) specifically authorizes EPA to disclose health and safety data collected under the statute, including data collected under TSCA § 8. TSCA § 14 embodies the legislative determination that health and safety data collected under TSCA should be available to the public and interested parties. In addition, each of the chemical management sections of TSCA, § § 4, 5, 6 and 21, for example, provide opportunities for public participation in chemical management decisions. Participation must be meaningful, and to be meaningful the public must have access to TSCA non confidential information.

The IURA is not associated with TRI ( Toxics Release Inventory) reporting under the Page 31 of 159 Emergency Planning and Community Right to Know Act, 42 U. S. C. secs. 11001 11050. EPA has considered expanding TRI reporting to include materials accounting information and did publish an advanced notice of proposed rulemaking ( 61 FR 51321 published on 10/ 01/ 96). For additional information on this topic, please see the EPA's website, currently http:// www. epa. gov/ triinter/ program. htm. TRI data serve a very different purpose than the proposed IUR data. TRI data are useful for site specific assessments of potential general population or environmental exposures to populations near facilities that manufacture, process or use EPCRA section 313 listed toxic chemicals. However, the TRI universe of chemicals is limited to a small portion of the chemicals on the TSCA Inventory.

6. Industrial Espionage and Terrorism Comment A. 6 1: President Clinton acknowledged in his 1995 Annual Report to Congress on Foreign Economic Collection and Industrial Espionage that many competitors " take advantage of the vast amount of competitive information that is legally and openly available in the United States." The 1996 Annual Report to Congress on Foreign Economic Collection and Espionage further substantiates that foreign economic espionage is increasing at a significant rate. In addition to using illegal means of organizing confidential business information, foreign companies are apt to " use accessible databases and information systems, including the Internet, to identify and target information." That industrial espionage presents a viable threat to the vitality of U. S.

business concerns is further demonstrated by the Economic Espionage Act of 1996, which is designed to protect against the theft and misuse of proprietary business information. The expanded list of information sought by the EPA under the proposed amendment poses a potential threat to the economic health of the nation. In addition, Federal intelligence agencies believe that EPA's expansive collection of data gives too much information about industrial chemicals to militia groups and would be terrorists. Inside EPA ( December 6, 1996).

Source: C1 019 Response A 6.1: The commenter is correct that the1995 Annual Report to Congress on Foreign Economic Collection and Espionage indicates that competitors take advantage of openly available information. However, the quote that the commenter has used fails to put the issue in context. The report describes many methods used to conduct industrial espionage, including classic agent recruitment; US volunteers; surveillance and surreptitious entry; specialized technical Page 32 of 159 operations; tasking foreign students studying in the United States; tasking foreign employees of US firms and agencies; debriefing of foreign visitors to the United States; recruitment of emigres;

elicitation during international conferences and trade fairs; open source information; use of private sector organizations, front companies, and joint ventures; corporate mergers and acquisitions; headhunting and hiring competitor's employees; corporate technology agreements;

sponsorship of research activities in the United States; hiring information brokers and consultants;

fulfillment of classified U. S. government contracts and exploitation of DOD sponsored technology sharing agreements; and tasking liaison officers at government to government projects. Within the open source data such as the Internet that the commenter mentions, the report also lists commercial databases, trade and scientific journals, computer bulletin boards, and corporate publications, as well as openly available U. S. government data.

The industrial espionage risk to companies is largely internal. As the 1995 Annual Report to Congress on Foreign Economic Collection and Espionage points out, " The individuals most likely to improperly acquire a company's information are the company's own employees". And as the 1996 Annual Report to Congress on Foreign Economic Collection and Espionage noted, " 74 percent of intellectual or proprietary losses stemmed from actions of " trusted relationships"

employees, former employees, contractors, suppliers, and so forth". According to a Department of Justice web site ( www. cybercrime. gov/ eeapub. htm), most of the cases prosecuted under the Economic Espionage Act of 1996 have been against current or former employees of companies who stole information from their employer.

Despite the intelligence risks, companies and their employees will continue to participate in activities such as conferences, trade and scientific journals, and corporate publications because of the benefits that these activities generate, although they should take precautions. Similarly, the government will continue to collect information because of the benefits that result. In the case of the IURA, EPA needs this information to carry out initial chemical screening. In order to safeguard the information, EPA has provided ample protection against industrial espionage through the CBI provisions of the rule.

The commenter is correct that the Economic Espionage Act of 1996 ( EEA) is designed to protect against the theft of trade secrets. The reporting of IURA information to EPA clearly does not constitute a violation of the EEA. This is highlighted by section 1833 of the Act, which states that it does not prohibit " any otherwise lawful activity conducted by a governmental entity of the United States, a State, or a political subdivision of a State".

While it is true that before the enactment of the EEA there were not federal statutes specifically targeted towards prosecuting the theft of trade secrets, this does not mean that the Page 33 of 159 federal government did not understand or appreciate the importance of trade secret information.

The mechanisms that EPA has established for the protection of TSCA CBI far predate the passage of the EEA. EPA has and will continue to protect information that is legitimately claimed as TSCA CBI.

The commenter has provided no information to justify its claim that the information to be collected under the IURA poses a potential threat to the economic health of the nation. EPA has carefully established mechanisms for the protection of TSCA CBI, including any such information collected under the IURA, and companies should follow these procedures if they have legitimate CBI claims. Therefore, EPA disagrees that the additional information being collected under the IURA poses a threat to the economic health of the nation.

EPA disagrees with the commenter's suggestion that the IURA will give too much information to militia groups and would be terrorists. The December 6 Inside EPA article that the commenter cites as proof is not about the IURA and is not accurate in any event. The article related to EPA's announcement in 1996 that it was considering collecting materials accounting data as part of the Toxics Release Inventory ( TRI) program under section 313 of the Emergency Planning & Community Right to Know Act ( EPCRA). According to the article, industry sources claimed that EPA's plan " could lead to an unprecedented amount of information on the Internet detailing when and how chemicals will move through communities, and when and how they will be entering and exiting facilities." This suggests that EPA planned to provide information on the routes, dates, and methods of shipment for chemicals entering and exiting facilities as part of the TRI program, which is not correct. EPA had suggested collecting a generalized group of materials accounting data elements, with the data aggregated over a one year time period and not related to particular shipments.

The comment is not germane to the IURA rulemaking because there are a number of differences between the materials accounting data that EPA was discussing under the TRI program and the information that it is collecting under IURA. For example, the CBI provisions under TSCA are substantially different than the trade secret provisions under EPCRA. The materials accounting data elements suggested for TRI were different than the new data elements being added by IURA. And TRI applies to facilities manufacturing ( including importing),

processing, or otherwise using a substance, while IURA only applies to manufacturers and importers.

In addition, EPA also disagrees with the comment because the commenter has mischaracterized the Inside EPA article it cites. The commenter claims that the article indicates that " Federal intelligence agencies believe that EPA's expansive collection of data gives too much Page 34 of 159 information about industrial chemicals to militia groups and would be terrorists," but the article makes no such statement. The article states that according to " industry sources" ( which are not named), members of the regulated community met with representatives of intelligence communities, including the Federal Bureau of Investigation and the Central Intelligence Agency,

to discuss industry's concerns with collecting materials accounting data under TRI. The article does not state that any representatives of these federal agencies agreed with the industry claims or even made any statements about the intelligence impacts of the TRI information. Nor does the article state that these federal intelligence agencies developed an official position on TRI materials accounting data or any other EPA data. Inaccurate claims by unnamed " industry sources" do not equate to conclusions by federal intelligence agencies about the potential impacts of TRI data or any other information the Agency might collect.

Comment A 6.2: The commenter states that, to the extent that EPA is intent on making more site specific information available through the IUR to the general public, there are significant concerns raised by the industry, Congress, and law enforcement experts concerning the threat of terrorism aimed at chemical facilities. The commenter encourages EPA to carefully evaluate what information is required for the limited purpose of risk screening, and to further limit Form U to only those data elements.

Source: C1 033 Response A 6.2: The Agency is quite aware of homeland security concerns and, while maintaining such information in house, will not be releasing information to the public that EPA considers inappropriate. EPA has carefully evaluated the information that is required for initial chemical screening and related purposes, and limited the IURA to those data elements. See the responses to comments A. 1 2 and A. 1 3 for further discussion of the utility of IURA information and the consideration given to the choice of data elements during the development of the IURA.

Comment A 6.3: EPA has proposed revisions to its TSCA Inventory Rule which would,

inter alia, require additional disclosure of plant site identification and maximum inventories of TSCA IUR chemical substances. EPA also proposes to require reporting of detailed processing and use information by companies reporting these chemical substances. ... The commenter states that it believes that disclosures of site information surrounding the use of its facilities, descriptions of explosives contained therein and other locator information to the public through governmental Page 35 of 159 submittals would represent a significant security risk because it could potentially give terrorist and others with criminal intent information about the location of and access to explosive materials.

According to the commenter, this has national security complications. The commenter states that it actively takes measures in its regulatory submittals to exclude or restrict such details so as to avoid divulging explosives related location information, and that it often works with regulatory agencies on effective alternatives to submittal of explosive site details that will satisfy the agency's need for review, while at the same time protect sensitive information. This has included options such as making the information available for on site review, redesigning of documents such as site maps to remove explosives locations and other creative solutions to prevent such information from reaching the public domain.

Source: C1 004 Response A 6.3: The commenter is confused about the information that EPA will be collecting under the IURA. Neither the proposed nor the final IURA require companies to report the maximum inventory of reportable substances. Furthermore, IURA does not collect detailed location information such as the site maps that the commenter mentions. The site and location information being added by IURA includes the county a plant site is located in, and the mailing address of the plant site where this is different from the physical address. EPA does not believe the this information represents a significant security risk. Furthermore, general location information ( including on the commenter's facilities) is already available through a variety of sources on the Internet.

The IURA adds processing and use information to the current IUR data collection. EPA does not believe that this information presents an undue security risk. In the case of the commenter, the company's web site contains detailed information on the explosive characteristics of its products. By contrast, IURA collects information on potential exposure to chemicals.

While the information on the commenter's web site is different from the processing and use data to be collected under IURA, it demonstrates that making even detailed technical information about explosive products readily available on the Internet does not necessarily create an unacceptable risk. EPA remains sensitive to security concerns. But based on the information that is already publicly available on the commenter's web site and through other sources, EPA does not believe that IURA data present a significant security risk that outweighs its utility for risk screening.

The IURA has been structured to limit the data collection to the information that is most Page 36 of 159 critical to EPA. This may serve to exclude information that would be of concern to the commenter. For example, IURA raises the threshold for reporting manufacturing information from 10,000 pounds to 25,000 pounds or more per site, which limits reporting to about 9,000 chemicals out of the 76,000 on the TSCA Inventory. A second threshold of 300,000 pounds limits processing and use data to approximately 4,500 chemicals. To the extent that the commenter is manufacturing mixtures, it should note that a person who creates a mixture by combining existing substances without a chemical reaction is not a manufacturer of those substances and therefore does not report those substances under IUR or IURA. Also, certain firearms and ammunition are exempt from TSCA regulation under TSCA section 3( 2)( B)( v).

7. Violating Federal Law Comment A. 7 1: Commenters claimed that the proposed rule did not satisfy the requirements of the Paperwork Reduction Act ( PRA). Specifically, commenter 0030 writes:

The proposal is inconsistent with the Paperwork Reduction Act. Section 5( a)( 1) requires EPA, by FY 2000, to have reduced paperwork burdens by 40 percent over FY 1995 levels. EPA's 1995 baseline was around 100 million burden hours. In FY1998 EPA's PRA burden was actually 119 million burden hours, and in FY 1999, the burden increased to 120 million burden hours. The 1999 calculation marks a 20% increase in paperwork burden from the 1995 baseline. SOCMA is concerned that the proposed IUR rule would exacerbate this trend.

Source: C1 009, C1 016, C1 018, C1 024, C1 026, C1 032, C1 033, C1 038, C1 041,

C1 043, C1 044, C1 048, C1 055, C1 060, C1 069 Response A. 7 1: As stated by the Office of Management Budget ( OMB) in the Fiscal Year 2002 Information Collection Budget: " To carry out its responsibilities carefully, effectively,

fairly and efficiently, the Federal Government needs access to information B lots of information."

( To access OMB's annual ICB reports go to http:// www. whitehouse. gov/ omb/ inforeg/ infocoll. html# icbusg.)

The Paperwork Reduction Act ( PRA)( 44 USC 3501 et seq.) provides a framework for ensuring that all of the Federal Government's information collections satisfy a programmatic need,

that the information has practical utility, and that the burden on the public of these activities is Page 37 of 159 curtailed. To fulfill its mission of protecting human health and the environment, the Environmental Protection Agency ( EPA) relies upon reports, recordkeeping, and third party reporting requirements to monitor compliance with environmental statutes and regulations.

The PRA ( 44 USC 3505( a)( 1)), directs the Director of OMB to establish annual government wide paperwork reduction goals of at least 10% for fiscal years 1996 and 1997, at least 5% for fiscal years 1998 through 2001, and to set annual goals to continue those efforts after 2001. These are government wide goals, not agency specific. OMB uses its annual ICB to establish the government wide goals, as well as individual agency goals. Each year EPA reports its achievements towards these goals, along with any anticipated burden increases, in EPA's annual Information Collection Budget ( ICB) that is submitted to OMB for inclusion in the OMB ICB for the federal government.

As reported by OMB in the Fiscal Year 2002 Information Collection Budget, a government wide decrease in annual paperwork burden was realized in only one year since 1989 ( i. e., 1993). According to OMB, given the continued expansion of Federal responsibilities and the growth of the nation over the last 20 years, the PRA goals in the aggregate are well beyond what is reasonably achievable. " In fact, in retrospect, of course, it would have been virtually impossible for the Federal government to achieve all of the goals over the last 20 years. The goals do encourage agencies to target burden reduction. However, had the goals been achieved, the Federal government would be collecting only about 40% of the information it did in 1980." ( See page 3 of OMB's Report " The Fiscal Year 2001 Information Collection Budget.")

The PRA directs all federal agencies to make efforts to reduce the overall federal paperwork burden, but the need to reduce burden is secondary to the requirement to fulfill the Agency's obligations to uphold the Nation's environmental laws. In the March 1995 Reinventing Environmental Information ( REI) report, EPA established a long term commitment to identify and eliminate obsolete, duplicative, and unnecessary monitoring, reporting, and record keeping requirements. For instance, by the end of fiscal year 1998, program changes and adjusted burden estimates reduced overall burden by more than 24 million baseline hours.

EPA is extremely sensitive to the PRA's directive for federal agencies to reduce unnecessary burden, and has worked consistently to find areas in which burden can be decreased to the maximum extent practical, and has carefully evaluated new information collections to ensure that our needs are met with the minimal burden possible. For IURA, this meant that EPA strived during the development of the amendments to ensure that any burden increase would be minimized to the greatest extent practical. For example, as reflected in the proposal, EPA raised the overall reporting thresholds, created exemptions for certain groups of chemicals, and Page 38 of 159 exempted small businesses from reporting. During OMB review of the final rule, EPA added another exemption based on low current interest in the IURA information, along with a process for adding chemicals under this exemption, and agreed to extending the reporting cycle to 5 years,

after the first cycle in 4 years. In addition, the screening level information provided under the IURA will allow the Agency to prioritize other collection activities for more detailed information about these chemicals.

As a result, EPA believes that the IURA is consistent with the letter and spirit of the PRA.

Comment A. 7 2: Commenters expressed reservation that the IUR would be duplicative of information available to EPA through other means, thereby violating both the PRA and Section 8( a) TSCA. One commenter maintained that:

in order to avoid unnecessary and duplicative reporting under Section 8( a) of TSCA, EPA must make a particularized showing justifying, for each targeted chemical, the Agency's need to collect specific downstream use and exposure information. See, e. g., AFL CIO v.

Occupational Safety and Health Admin., 965 F. 2d 962 ( 11 th Cir. 1992).

Source: C1 003, C1 016, C1 024, C1 027, C1 031, C1 033, C1 037, C1 043, C1 048,

C1 055 Response A. 7 2: Regarding the requirements of TSCA Section 8 and the PRA to avoid duplication, EPA has demonstrated in supporting documents to the proposed and final rules that data currently available through alternative sources is inadequate for the Agency to fulfil its legal mandate in TSCA to control chemical risks. Site level data on production and use is simply unavailable from any other source. The duplication issue is addressed more fully in comments in section A. 3 of this document. EPA finds the cited case, AFL CIO v. OSHA, to be inapplicable.

That case involves the ability of OSHA to established PELs under the OSH Act. It does not address EPA authority under TSCA section 8.

Comment A. 7 3: A commenter writes: " The NPRM provides insufficient justification that the Agency has acted in conformity with the congressional intent expressed in section 2( c) of TSCA to implement the act ` in a reasonable and prudent manner' and to ` consider the environmental, economic, and social impact' of its proposed and final actions." Page 39 of 159 Source: C1 043 Response A. 7 3: EPA believes the benefits to IURA as proposed justify the costs, as outlined in chapter V of the economic analysis for the proposed rule. In summary, as EPA and the public do not have the necessary information to make educated decisions about controlling risks from chemicals in commerce, IURA corrects that failure and will result in better risk management, both public and private. While the benefits are impossible to quantify a priori, EPA believes they will be substantial.

Comment A. 7 4: One commenter stated that the proposed IURA will impede innovation by " imposing defacto restrictions on the use of certain materials, adding new burdens, and causing the disclosure of CBI." The commenter stated that the proposal runs counter to an underlying TSCA policy prohibiting barriers to innovation.

Source: C1 069 Response A. 7 4: The Agency disagrees with the submitter's contention that the IURA will impede innovation. The amendments in no way impose restrictions on the use of materials.

Rather, as further explained in Section E of this document, the CBI revisions will improve the Agency's ability to protect legitimate CBI while helping to ensure that data that do not meet the CBI requirements are available for use. The amendments do increase the burden associated with reporting under the IUR. However, these increases are outweighed by the expected benefits from the use of the reporting information. Further discussion on burden of these amendments can be found in Section G of this document.

The comment "... causing the disclosure of CBI" refers to the proposed CBI reassertion requirement, which EPA did not finalize.

B. Specific Data Elements Comments 1. General Data Quality and Accuracy Comment B. 1 1: A number of commenters stated that the data provided through the IURA would be of limited accuracy and would be inferior to the data the Agency has collected in other programs. The commenters felt that the IURA data will be so uncertain that they will not Page 40 of 159 be useful to predict chemical risk. One commenter stated that there are many other factors that can significantly affect the potential for exposure, such as engineering controls and personal protective equipment practices, the nature of the activities in which workers are engaged, and the physicochemical characteristics of the chemical substances. This commenter believes that the data collected under the IURA will provide a limited and potentially inaccurate view of potential exposure.

Source: C1 007, C1 011, C1 015, C1 017, C1 018, C1 020, C1 021, C1 024, C1 026,

C1 030, C1 031, C1 033, C1 038, C1 047, C1 048, C1 051, C1 055, C1 060 Response B. 1 1: EPA considered the types of information needed for screening level exposure and risk assessments and believes the information collected through the IURA will have the necessary level of adequacy, accuracy, validity, and reliability for these assessments. Before proposing the IURA, EPA analyzed various exposure data collections and analyses to determine the data elements needed for a screening level exposure assessment. This discussion and analysis are in the document " Inventory Update Rule ( IUR) Amendment Technical Support Document:

Exposure Related Data Useful for Chemical Risk Screening" ( Ref. 16). EPA agrees that there are many ways to increase the accuracy, validity, and reliability of the data. However, in developing the IURA and considering various alternatives, EPA maintained a balance between data needs for exposure screening and the burden associated with providing the information. If the Agency were to require very precise, specific reporting, company burden would increase to an unacceptably high level. Although many factors can affect exposure potential, the data provided by the submitters will provide useful baseline information.

Commenters' suggestions implied that complete information about exposures including use of personal protective equipment and engineering controls would be necessary for even a screening level analysis of potential exposure. However, exposure and risk analyses performed by the Agency in general and OPPT in particular are graduated and data driven. Within EPA, more accurate and reliable reviews are desired as levels of concern increase. The Agency then needs increased quantity and quality of data, along with more detailed and exacting methodologies of risk review. Based on its years of experience assessing chemical risks through programs such as the New Chemicals Program, the Agency believes the IURA data will provide information adequate to perform initial exposure screens of chemicals, and to prioritize and make basic risk management decisions about those chemicals of greatest concern. Those decisions then can prompt more detailed assessments, as required. Page 41 of 159 The Agency considered the data accuracy and reliability needed for screening level analyses and took several steps to ensure that the data to be collected under IURA would meet those needs. Screening level data need not be absolutely precise, but should be accurate and reliable enough to make usable and defensible technical assessments. The IURA will supply information the Agency does not currently possess. Without this information, EPA either would not screen these chemicals, or would screen them using outdated or anecdotal information, or would make estimates using modeling data. Personal protective equipment is discussed in section B. 6. b of this document.

Comment B. 1 2: EPA is requiring submitters to provide information that is not typically tracked in the format that EPA is requesting. For instance, EPA is requiring the reporting of average and maximum concentration of chemicals in formulation. According to the commenter,

this information is difficult to obtain because many process changes are based on product quality.

Therefore, the concentration of a chemical in a product can vary wildly and would be difficult to estimate with any precision. Also, commenters stated that EPA's requirement that submitters provide concentration data on a weight/ weight basis differs from industry practice which typically uses a weight/ volume calculation to represent concentration. Therefore, EPA's requirement would be an additional unnecessary burden.

Source: C1 007, C1 014, C1 015, C1 018, C1 021, C1 023, C1 027, C1 032, C1 033,

C1 068 Response B. 1 2: EPA had proposed that submitters report the both the average and maximum concentrations of the chemical when leaving the manufacturing site. EPA has eliminated the requirement to report average concentration from the final rule in response to commenters' explanation of the difficulty of determining the average concentration. However,

EPA disagrees with the claim that tracking maximum concentration at the time a substance leaves the submitter's site would be overly burdensome. EPA is requiring submitters to provide their best estimate of the data elements in the IUR form to the extent that an estimate is reasonably ascertainable ( in the case of data elements reported on Parts I and II of Form U) or is readily obtainable ( in the case of data elements reported on Part III of Form U). The Agency believes that submitters have sufficient expertise in the production and use of their products to provide reliable estimates of the IUR data elements, including maximum concentration. If a submitter cannot reasonably ascertain an estimate for the maximum concentration information required under Page 42 of 159 section 710.32( c)( 3)( vii), or readily obtain an estimate for the maximum concentration information required under section 710.32( c)( 4)( ii)( D) of the regulatory text, the submitter need not respond to the data element.

Concentration is an important variable to consider when estimating the magnitude of potential exposures. EPA recognizes that the concentration of an IUR reportable chemical may vary from shipment to shipment when leaving a submitter's site in the case of the requirement at section 710.32( c)( 3)( vii), or from product to product within a commercial and consumer product category in the case of the requirement at section 710.32( c)( 4)( ii)( D) of the regulatory text.

However, the Agency does not intend for submitters to go to great lengths to determine what concentration ranges to select for IURA reporting. Instead, EPA is simply requiring that submitters select a range of concentrations from a list of given ranges ( less than 1% by weight; 1

30% by weight; 31 60% by weight; 61  90% by weight, and greater than 90% by weight) to indicate the maximum concentration of an IUR reportable chemical across shipments leaving the submitter's site. EPA and others will primarily use this information for preliminary risk screening.

The Agency has determined that reporting of concentration data in ranges will be sufficient for this purpose, and indeed has some advantages. Information presented as a point estimate can lead the user to infer that there is a greater precision to the data than actually exists, while information presented in a range emphasizes the inherent variability in the information. Since the maximum concentration of a chemical at a site can change over time, it is appropriate to collect the information in a range.

Information about the maximum concentration of a chemical substance present at processing and use sites is frequently used in chemical risk screening in the review of Premanufacture Notices ( PMNs) for new chemical substances required by Section 5 of TSCA and can be used in screening chemicals on the TSCA Inventory. For example, EPA has developed standard methods to estimate dermal exposures that workers may experience while performing common industrial operations such as sampling and loading chemicals into drums [ See Fehrenbacher, M. C., " Dermal Exposure Assessments" in A Strategy for Assessing and Managing Occupational Exposures, J. R. Mulhausen and J. Damiano, eds., AIHA Press, Fairfax, VA ( 1998).]. These standard methods incorporate maximum concentration information to arrive at an upper limit in exposure estimates. If EPA is aware that a chemical is processed or used as a fraction of a mixture with other chemicals, exposure estimates may be adjusted accordingly.

Likewise, a chemical that is a component of a mixture exerts a lower vapor pressure than it would in its pure form. Because higher vapor pressure is associated with higher inhalation exposure, a chemical's concentration in a liquid mixture impacts the exposure assessment. Page 43 of 159 Initially, the Agency will use the maximum concentration data collected under the IURA to screen and prioritize chemicals to determine whether further evaluation is necessary. By using this limited set of exposure and use data for relative exposure and risk ranking, the Agency can focus testing and analysis priorities on those chemicals with the greatest potential for risk.

Without this information, chemicals will be evaluated using generic assumptions on exposure and use, which could lead EPA to further investigate a broader set of chemicals than is needed.

In addition, EPA is not aware of information or data that indicates a prevalence of use of weight / volume relative to weight/ weight. If weight/ volume data were reported under the IURA,

EPA would also require reporting of specific gravity of the mixture in order to utilize the reported information correctly. Therefore, for ease and consistency of reporting under IURA, EPA has chosen weight/ weight as the sole basis for concentration reporting.

Comment B. 1 3: One commenter asked whether EPA intends for the sum of all of the percent production volumes reported under section 710.32( c)( 4)( i)( D) of the proposed regulatory text or the sum of the percent production volumes reported under section 710.32( c)( 4)( ii)( C) of the proposed regulatory text to total 100 percent. The commenter gave as an example a case where if there are 20 or more uses of a chemical, and only the top 10 uses are reported, the total will add to less than 100 percent, and the commenter felt that in such a case the database would likely contain significant inconsistencies, omissions, and errors.

Source: C1 033 Response B. 1 3: EPA understands that by limiting the submitters' estimates of percent production volume attributable to each of only the top 10 industrial function categories and commercial and consumer use categories, the values may not always add up to 100 percent of the submitter's total production volume. In fact, there may be times when the values add up to over 100 percent. However, this will not significantly affect the quality of the data submitted and will not result in inconsistencies in the database. Screening level estimates are intended to provide order of magnitude estimates for ranking one chemical relative to another; failure to account for a small percentage of a chemical's usage will likely have a small effect on exposure estimates. EPA has extensive experience with the type of data to be collected under the IURA through the PMN program and UEIP, and finds that industry is generally able to provide reasonable exposure and use data. The reasonableness of data is determined using a combination of sources, including industry contacts, historical data, technical references, and professional judgment. Page 44 of 159 2. Double Counting of Data Comment B. 2 1: Commenters were concerned about the potential for " double counting"

of information collected through IURA. They pointed out that a single customer may have several suppliers and that each supplier would be required to predict the customer's chemical usage and worker exposure, leading to inflated estimates of the number of use sites and the number of potentially exposed workers. One commenter pointed out that this problem can also occur within a site, when a chemical is used in multiple operations throughout a plant site. The same worker activities will be reported in duplicate when multiple operations occur at one site.

One commenter suggested that companies rather than sites report downstream use information as a way to minimize the double counting.

Source: C1 007, C1 009, C1 011, C1 013, C1 016, C1 018, C1 021, C1 024, C1 027,

C1 028, C1 033, C1 038, C1 055, C1 056, C1 060, C1 061 Response B. 2 1: EPA recognizes that the potential for double counting exists under certain scenarios, but believes that this issue is not as great as suggested, and that the quality of the data that will be collected under IURA will be sufficient for the purposes for which EPA and other IUR information users require it. An primary purpose of the IURA data is to aid in relative exposure and risk screening of IURA chemicals, not to generate specific exposure values for use in detailed risk assessments. Because IURA information will be used for screening purposes,

uncertainties such as those posed by the potential to double count are minor. For instance, in the first example listed about in the submitter comment, the number of user sites will be greater, but the use volume per site will be less. While a more accurate picture would be to decrease the number of use sites and increase the use volume per site, EPA believes that at the screening level this distinction is relatively minor and is only likely to occur very occasionally. This belief is founded in part on the fact that the majority of chemicals reporting to past IUR collections originate from a single site.

Within a site, multiple processing or use activities can create multiple exposure pathways.

EPA is interested in identifying the various exposure scenarios and obtaining a general idea of the magnitude of the exposures associated with those pathways than in precisely measuring those exposures. Because of this, potential double counting is not expected to dramatically affect the quality of the data for with respect to the purposes to which the data will be put.

While reporting use information on a company wide basis versus a site specific basis may Page 45 of 159 help address the potential, albeit minor, issue of double counting, EPA has other reasons for preferring site specific reporting. For instance, site location is used in conjunction with streamflow data from the U. S. Geological Survey to assess the environmental impact of sitespecific releases to the aquatic environment. Site specific information is likewise used to assess the magnitude and duration of exposure of workers to chemical substances. Additionally,

sitespecific information enables EPA to assess the extent to which a change in manufacturing,

processing, or use of a chemical substance changes the type or form of exposure of humans or the environment. Reporting on a company wide basis for a company that has a variety of sites, each producing one or more IURA reportable chemicals, would result in a less accurate and informative description of the effect of chemical manufacture processing and use on the environment.

Comment B. 2 2: Commenters stated that double counting occurs when the production volume for a chemical is originally reported for quantities produced at the manufacturing site,

then is shipped out of the country, and then imported back into the United States. This results in an artificially inflated production volume.

Source: C1 023, C1 028, C1 056, C1 060 Response B. 2 2: As under the existing IUR, production volume amounts will continue to be reported on a per site basis under the IURA. The IUR has provided EPA with a general understanding of who manufactures which chemicals, where the chemicals are manufactured ( including imported), and in what quantity, over the course of a given year. IUR information is used to identify potential exposure concerns. Production volume associated with the manufacturing of a chemical is attributed to the manufacturing site, with potential exposures to workers and others attributed to the manufacturing site. Production volume associated with the import of a chemical is likewise attributable to the importation site, with potential exposures to workers and others attributable to the importation site. These are two different exposures, and EPA needs to collect information for each site. While the overall national production volume of the chemical which is manufactured, exported, and imported all in the same year may include double counting of the same volume ( and therefore an inflated production volume). The quantity of a chemical consumed in the United States can be calculated by subtracting exports and adding imports to the quantity produced.

EPA has considered ways of " tagging" information that covers the same production Page 46 of 159 volume reported in two different places. EPA determined that tracking individual shipments of IUR reportable chemicals would place too much burden on industry. Other factors affect production volume levels reported. For example, the Agency is aware that certain chemical manufacturers have taken into consideration the IUR reporting schedules in determining whether/ when to manufacture ( including import) an IUR reportable chemical.

Comment B. 2 3: Several commenters suggested that the argument that multiple counting is not significant because the numbers are reported in ranges is not logical or convincing. The commenters suggest that EPA consider requiring IUR reporting in a manner similar to the SIDS Initial Assessment Reports ( SIAR) used in OECD's SIDS program, which would eliminate the possibility of multiple counting as data from all manufacturers are aggregated in a single report.

Source: C1 031, C1 033, C1 061 Response B. 2 3: EPA's argument that range reporting reduces the importance of double or multiple counting is flawed, and EPA withdraws that argument. EPA agrees that range reporting may not have a significant impact in reducing double counting. However, EPA still believes that double counting will not be a significant problem with IURA reporting. The fact that, based on past IUR reporting, most chemicals are reported by one site highlights the fact that the possibility of multiple counting is minor. As IURA information is intended for use in screening level exercises, the small incidence of multiple counting is immaterial. See the response to comment B. 2 1 for further discussion.

EPA examined the idea of using a SIAR type of reporting form, which is used by OECD for SIDS chemicals. The SIAR form aggregates information for all manufacturers, thus protecting company specific information. However, aggregation would eliminate a great deal of flexibility from the IURA data elements. To require submitters to provide data in an aggregate form would severely limit the ultimate utility of the IURA data collection. As described in the response to comment B. 2 1, the Agency has a need for site specific information. Additionally,

there may be many ways, yet unknown to EPA, which the IURA data can be manipulated and analyzed for even greater utility than what EPA currently envisions. EPA also believes it is infeasible to require SIAR type reporting as that would require manufacturers to incur greater reporting burden by aggregating their data before submitting it to the EPA and would complicate the submission of CBI information. For instance, in the case of a chemical for which the Agency would normally received submissions from several manufacturers or importers, those submitters Page 47 of 159 would need to consolidate information into one report prior to submission to EPA. If one of those manufacturers wished to maintain confidentiality for their information, they would not be able to provide their information to the others for consolidation as that act would likely cause the information to no longer qualify for CBI protection.

3. Site and Company Identification Comment B. 3 1: EPA should include a ' not applicable' response as an option for Facility Identification Number ( FIN). Commenters state that some facilities have not been assigned a number while other facilities have more than one FIN. One commenter suggests that EPA should require the reporting of a TRI facility identification number ( if a site has one) because this would not create unnecessary burden to industry. Commenters stated that a comprehensive Facility Registry System ( FRS) would simplify identification of data among numerous EPA reporting requirements.

Source: C1 031, C1 033, C1 047, C1 065, C1 068 Response B. 3 1: EPA agrees that use of a comprehensive facility identification number would simplify the collection and use of data submitted to the Agency pursuant to multiple program reporting requirements. As a result, EPA is now taking steps to institute such an Agency wide numbering system. In this light, reports submitted to EPA under the IUR will be assigned such a number by the Agency ( referred to generically as an " EPA number"). Submitters will not be responsible for obtaining this number, nor for filling in this data field on the Form U. EPA will itself make number assignments either directly on the reporting form after it is received back by EPA from the submitter, or prior to mailing out the form to a submitter. As a result, the FRI data element originally present in the proposed regulatory text at section 710.32( c)( 2)( ii) has been eliminated from the final rule.

4. Form U, Part II Data Elements  Manufacturing Information a. Production volume Comment B. 4a 1: One commenter felt that simply knowing the quantity of the chemical handled annually provides little insight regarding the relative risks associated with a manufacturing process. In addition, commenters felt that the amount of chemical used is not directly related to Page 48 of 159 the maximum amount present in a site at any given time, and disparities in chemical usage between sites are likely to occur when the same chemical is used in multiple industries.