## 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
11/20/02Table 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 116D. 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-DocketPage 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 EquipmentPage 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 ProjectPage 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 r each 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 IURAPage 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 substancesPage 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 us e 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 preventingPage 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) w ill 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 includingPage 8 of 159 outreach and training. This information w ill 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 targetedPage 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 h azard 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 onPage 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-chang ing 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 w ill 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 whichPage 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 ut ility’ 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 reliab ility, 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, asneeded 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 wouldPage 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 reliab ility 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 s upply 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 w ill 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 w ill 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 w ill 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 envisionedPage 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 h azard 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 s upporting 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 inpreamble 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 alreadycollected under existing or former rules. For example, they
stated that data collected under two other TSCA rules

Cthe PAIR and the Comprehensive Assessment Information Rule (CAIR) rules

Chave 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 (UC SS), 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 SupportPage 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 w ill 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 s upport 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 andPage 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 thatPage 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 f illed 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 h azard. 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 providingPage 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 s imilar 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 andPage 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 submittedPage 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 usePage 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 anPage 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 fac ilities filing more than 137,000 reports annually, with 5,100 more fac ilities 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 collectedPage 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 CommentsPage 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 inLegislative 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 inLegislative 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 thePage 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 (D ecember 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 technicalPage 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. S imilarly, the government will continue to collect information b ecause 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 thePage 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 w ill give too much information to militia groups and would-be terrorists. The D ecember 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 s uggests 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 muchPage 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 fe deral 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 governmentalPage 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 presentsan 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 mostPage 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 FY 1998 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 responsib ilities 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 isPage 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 responsib ilities 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, andPage 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 notPage 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 in accurate 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 reliab ility 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 s upply 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 underPage 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 w ill 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 w ill 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 mayPage 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 withstreamflow 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 assessthe 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 productionPage 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 s imilar 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 submittersPage 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 s uggests that EPA should require the reporting of a TRI facility identification number (if a site has one) b ecause 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 toPage 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.

Source: C1-0017, C1-019, C1-033

Response B.4a-1 : Knowing the quantity of a chemical produced does have value in screening potential exposures and risks associated with a manufacturing process and with other downstream (processing and use) processes. The production volume of a chemical substance in aparticular application can be used with other exposure-related information to estimate exposurerelated parameters for particular workplace activities that can lead to exposures. For example, production volume and chemical concentration information can be used to estimate the total volume of shipping containers needed to transport a formulation containing the chemical. For a semi-volatile chemical, this shipping volume may be used to estimate releases of vapor to air and resulting potential doses for workers by inhalation. The production volume can also be used with emission factors particular to an application to estimate releases that can lead to off-site exposures. But because the volume of chemical usage alone is often inadequate, EPA is amending the IUR to collect additional information needed to increase confidence in the screening level exposure and risk assessment. EPA is not collecting information on the maximum inventory of a chemical substance present at a facility under the IURA. Although the maximum inventory of a chemical at a facility is useful in planning for emergencies, the amount of a chemical manufactured, processed, and used at a facility is of greater significance when estimating occupational and environmental risks. EPA's analysis (see ref. 16) showed a correlation between maximum amount present onsite and throughput volume; this correlation has been used to develop emission factors which are sometimes used to develop rough estimates of annual releases in the Premanufacture Notification program for new chemical substances when throughput volume is known. Other information collection rules including the Toxics Release Inventory collect information on the maximum inventory of a chemical substance at a facility. The additional exposure information under the IURA will augment other data (such as EPA-derived emissions data, existing IUR production volume data, etc.) to develop screening level exposure assessments. EPA agrees that when a chemical substance is used by more than one industry, the usage rate is likely to vary between industries. For this reason, EPA is collecting use and exposure information in such a way as to highlight the differences in chemical use among different
industries. Because each situation w ill present a different exposure scenario, EPA is interested inPage 49 of 159 identifying the disparities in chemical use between sites and/or industries.

b. Concentration data

Comment B.4b-1 : One commenter expressed concern about EPA’s proposal that submitters report concentration data in ranges because EPA does not specify whether it would require manufacturers (including importers) to do specific chemical testing or statistical analysis to report concentration data or whether submitters should merely estimate concentrations. The commenter found it unclear whether a submitter should report the average and maximum concentration level for each product it sells/imports, simply estimate the total average concentration of all units sold/imported, or record each shipment and statistically determine the average concentration level.

Source: C1-033

Response B.4b-1 : EPA and others will primarily use the IURA information for preliminary exposure and risk screening purposes, and the reporting of concentration data in ranges is of sufficient precision for that purpose. Chemical testing or statistical analyses will not be necessary to either make the required estimates or to calculate actual maximum concentration values. The concentration data reporting requirements under IURA are chemical-specific, rather than product-specific, therefore submitters will not need to report concentration levels for each product sold/imported. For the maximum concentration information required under section 710.52(c)(3)(vii) of the amended regulatory text, submitters must provide the maximum concentration in which an IUR-reportable chemical is found at the time the chemical substance leaves the submitter's site (i.e. out of all the shipments that leave the site). Such information is required to the extent that it (or an estimate) is "reasonably ascertainable" by the submitter. EPA is not requiring the submitter to report average concentrations under the final rule. This data element, which EPA had proposed adding, has been eliminated from the final rule. See "Instructions for 2006 Inventory Update Rule Reporting Under the Toxics Substances Control Act (TSCA)" for further information concerning maximum concentration information reporting (Ref 20). Under section 710.52(c)(4)(ii)(D) of the amended regulatory text, submitters must provide the maximum concentration of each reportable chemical likely to be present in commercial and consumer products manufactured (including imported) at sites under the submitter's control and atPage 50 of 159 sites where the submitter's commercial and consumer products are distributed directly or indirectly. Such information is required only to the extent that it (or an estimate) is "readily obtainable" by the submitter. EPA recognizes that concentration data may vary and may be difficult to report in some instances, particularly in product formulations. EPA is not requiring the reporting of concentrations in all products and formulations but rather only one maximum concentration, regardless of the chemical substance's physical form or product formulation.
Because concentration information w ill be reported in ranges, and not as individual values, this information should be known to or reasonably ascertainable by most submitters (in the case of the maximum concentration information reported under section 710.52(c)(3)(vii) of the amended regulatory text) or readily obtainable by most submitters (in the case of the maximum concentration information reported under section 710.52(c)(4)(ii)(D) of the amended regulatory text). It will not require specific chemical testing or statistical analysis beyond any testing or analyses already done by the submitter as part of normal operations. EPA anticipates that chemical importers will often r eceive maximum concentration information from their suppliers and manufacturers will typically obtain this information from samples analyzed for quality control.

c. Physical Form

Comment B.4c-1 : Several commenters suggested the need for variations on the specifics of physical form reporting, but generally agreed with reporting the physical form as the chemical leaves the site of manufacture/import. For example, one commenter suggested expanding the types of physical forms that can be reported. Other commenters recommended that EPA allow submitters to report more than one physical form for each reportable substance, because a substance may leave a site in more than one physical form.

Source: C1-021, C1-031, C1-033, C1-042, C1-047, C1-056

Response B.4c-1 : EPA agrees that multiple physical forms should be reported and is requiring in this final rule that submitters report all physical forms of a substance when the substance leaves the site of manufacture/import. Reporting on all physical forms in the IURA will lead to a better assessment of exposure to a chemical substance. For example, processing of a fine, nonagglomerating powder could result in occupational exposure by inhalation of chemical dust; processing of the same chemical as a liquid solution would eliminate, or at least reduce, the inhalation risk (the liquid could become an aerosol and be inhaled, depending on the processingPage 51 of 159 activity). By combining data elements on the physical form of a chemical substance, its production volume, and the percentage attributable to each industrial processing or use activity, a screening estimate of the potential exposure associated with manufacturing or processing of a chemical substance can be derived. The resulting exposure assessment will be more representative and less conservative than if the physical form were unknown. EPA does not agree with expanding the types of physical forms to be reported. EPA’s experience with the six categories proposed by EPA (see section 710.32(c)(3)(viii) of the proposed regulatory text) as part of EPA’s exposure screening of more than 20,000 chemicals in its New Chemical’s Program indicates that these categories will be adequate for risk screening purposes. Additional categories would not improve EPA’s or others’ abilities to screen chemicals for potential exposure.

5. Form U, Part III Data Elements - Processing and Use Information

a. General Downstream Reporting

Comment B.5a-1 : A commenter stated the collection of processing and use information is overly broad and unnecessarily detailed.

Source: C1-032

Response B.5a-1 : EPA is requiring the reporting of processing and use information to assist EPA and others in screening potential exposures and risks resulting from industrial chemical operations and commercial and consumer uses of chemical substances. EPA considered the types of information needed for screening-level exposure and risk assessments and believes the information to be collected through the IURA will have the necessary level of detail and substance for these assessments. The specific data requirements were determined using the Agency’s experience with a variety of programs, as described in “Inventory Update Rule (IUR) Amendment Technical Support Document: Exposure-Related Data Useful for Chemical Risk Screening" (ref. 14). Additional detail regarding the use of processing and use information is described in response to comments A.1-1 and A.1-2.

Comment B.5a-2 : Commenters stated EPA did not consider the logistics and issues related to the collection of downstream information. Commenters stated that the accuracy andPage 52 of 159 reliability of much of the information called for in Part III of amended Form U would be highly questionable because it relates to fac ilities, activities, and products that are not under the direct or indirect control of the company submitting the Form U.

Source: C1-007, C1-009, C1-011, C1-013, C1-015, C1-017, C1-018, C1-021, C1-024, C1-038, C1-042, C1-044, C1-048, C1-051, C1-055

Response B.5a-2: EPA recognizes that submitters may not always have detailed information about how the chemical(s) they make are used. However, EPA believes that industry has a greater knowledge than EPA about its own operations and the uses of chemicals it manufactures and sells. In addition, based on our experience with the PMN program, many stakeholder meetings, discussions about voluntary risk management programs, and industry’s various self-regulation initiatives, the Agency believes that most submitters have at least some basic information about downstream uses, including the information that would be reported under IURA. EPA believes that the data will be sufficiently reliable for the Agency and others to use for screening-level risk assessments and prioritization. EPA has extensive experience with data typical of IURA through its PMN program and UEIP, and believes that industry is generally able to provide accurate processing and use data. The Agency has received thousands of PMN submissions over the past several years. The vast majority of PMN submissions did contain some level of exposure information in processing and use similar to those required under the IURA.

Comment B.5a-3 : Commenters suggested that a "no data" response be added for downstream information which is unknown. The proposal stated that information on downstream uses must only be reported to the extent it is readily obtainable but then goes on to state that the submitter should provide estimates. Another commenter stated that reporting in ranges will turn the downstream reporting into a guessing game if the information is not readily obtainable. Commenters are concerned about providing estimates and then certifying the information is

accurate.

Source: C1-007, C1-009, C1-011, C1-014, C1-015, C1-016, C1-017, C1-018, C1-020, C1-021, C1-023, C1-024, C1-027, C1-028, C1-030, C1-031, C1-032, C1-033, C1-037, C1-038, C1-044, C1-046, C1-051, C1-055, C1-068

Response B.5a-3 : EPA is not providing an "unknown" or "no data" response on the formPage 53 of 159 because EPA believes that submitters often possess knowledge concerning the downstream use of chemicals they sell to their customers, even though the submitters do not control their customers’ sites. EPA’s experience with over 30,000 PMNs demonstrates that companies have some knowledge of the intermediate and ultimate uses of their products and therefore EPA believes that it is reasonable to assume that the manufacturers submitting processing and use information would be aware of the primary uses for their chemical. Because of this knowledge, EPA believes the submitter will also be able to provide a reasoned, educated estimate. If the submitter is unable to do so, it should leave a blank response. Further instruction is provided in the final rule’s guidance document. Reporting in ranges will lessen the reporting burden when the precise quantities of a chemical directed to multiple end uses are not known. The submitter must divide the amount of chemical shipped to each customer among the kn own uses and then aggregate these estimates to obtain an estimate of the amount of the chemical directed to each use. Although this may result in some uncertainty in the data reported, an estimate made in good faith by the chemical manufacturer or importer is preferable to no estimate at all. The person reporting under the IUR must certify that to the best of her knowledge and belief that all information reported is complete and accurate. If the report is inaccurate because of information unknown to and not readily attainable by the person reporting, that person has, nevertheless, fulfilled her obligation of accuracy and completeness.

Comment B.5a-4 : Several commenters stated that EPA is attempting to circumvent the “reasonably ascertainable” standard mandated by TSCA by lessening the requirement to "readily obtainable," which is not what is required by the statute. Commenters stated that because the data required are not "reasonably ascertainable," EPA’s goals can not be achieved by information collected using the "readily obtainable" standard.

Source: C1-011, C1-014, C1-027, C1-031

Response B.5a-4 : "Known to or reasonably ascertainable by" is the current standard for data collection under which the IUR operates and is the standard authorized by TSCA section 8(a). "Known to or reasonably ascertainable by" means all information in a person's possession or control, plus all information that a reasonable person similarly situated might be expected to possess, control, or know. The "known to or reasonably ascertainable by" standard is applicable to chemical manufacturing by the submitter.Page 54 of 159 "Readily obtainable" is a lesser standard EPA is applying to the provision of information concerning the processing and use of chemicals subject to the IURA. The readily obtainable standard is less inclusive than the reasonably ascertainable standard in that the former is limited to information known or available to management or supervisory employees of the submitter. Readily obtainable does not require additional effort to collect information on processing or use of chemicals by others not under the control of the submitter. Although the Agency is requiring submitters to provide only information in their possession, EPA believes that submitters often possess knowledge concerning the downstream use of chemicals sold by the submitter to their customers, even though the submitter does not control its customers sites. EPA’s experience with over 30,000 PMNs demonstrates that companies have some knowledge of the intermediate and ultimate uses of their products. If EPA applied the "known to or reasonably ascertainable by" standard to downstream information reporting, manufacturers would be required to report these data and would be required to go to greater lengths to obtain these data than is required by the "readily obtainable" standard. Therefore, EPA believes that the "readily obtainable" standard for reporting of downstream information is appropriate and will provide EPA with the necessary data to conduct risk screening.

Comment B.5a-5 : Many commenters were concerned about obtaining downstream
information from customers. One commenter stated it has no information from its customer companies about where they use the material, or if they use it at more than one site. Commenters said that such information is difficult to obtain because most customer companies are unw illing to cooperate. Commenters stated this was an even greater issue for product sold through brokers, where manufacturers do not have access to the purchasers. Commenters stated that EPA should clarify what information is readily obtainable and what is the duty of manufacturer to contact downstream users. One commenter stated EPA needs to clarify the reporting obligation of toll
manufacturers.

Source: C1-009, C1-011, C1-013, C1-014, C1-015, C1-016, C1-017, C1-018, C1-021, C1-023, C1-024, C1-026, C1-027, C1-028, C1-031, C1-033, C1-037, C1-046, C1-047, C1-055, C1-068

Response B.5a-5 : EPA recognizes that submitters may not always have detailed information about how the chemical(s) they make are used. As a result, submitters will only bePage 55 of 159 required to report this information to the extent it is "readily obtainable" (see Unit II.F.6.a. of the Final Rule Preamble). In addition, based on its experience with the New Chemicals Program, the UEIP, stakeholder meetings, discussions with industry about voluntary risk management programs, and industry’s various self-regulation initiatives, EPA believes that most submitters have at least some basic information about the downstream uses that will be reported under IURA. Submitters need not report the number of downstream facilities processing chemicals they manufacture or import unless the amount manufactured and imported exceeds 300,000 pounds at a single site in the reporting year. Manufacturers and importers exceeding this threshold generally have knowledge of their customer’s operations and the number of customer sites to which their chemical products are shipped which can be used to estimate the number of customer processing sites. Reporting in ranges will lessen the burden on the submitter b ecause producers and importers can be reasonably expected to have knowledge of the scale of their customers operations. If definitive information is not readily available, the person reporting must use the best information readily obtainable but need not contact the customer. Additional guidance and examples for completing IURA Form U will be provided in the Technical Guidance Document. The reporting obligation for toll manufacturers is not affected by the IURA. As discussed in the Agency’s Q&A document for the IUR (currently available at http://www.epa.gov/opptintr/iur98/tscaqa.htm ), the company which actually manufactures the substance is the company which is required to report.

Comment B.5a-6 : Commenters suspect that their customer’s information is sensitive information, and requesting that information may jeopardize their customer relationship. One commenter stated that there was a risk of potential litigation from their customers due to the downstream IURA reporting.

Source: C1-003, C1-011, C1-014, C1-016, C1-017, C1-018, C1-047, C1-055, C1-073

Response B.5a-6 : EPA does not believe submitters will be reporting sensitive customer information as the processing and use information will be reported in ranges, will be agglomerated information from individual customers and other downstream users, and will not be attributable to any specific processor or user.

Comment B.5a-7 : A commenter requested that EPA clarify the sentence "Persons subject to this paragraph must report industrial processing and use information for each reportablePage 56 of 159 chemical substance at sites under their control and at sites that receive a reportable chemical substance from the submitter directly or indirectly (including through a broker/distributor, from a customer of the submitter, etc.).” The commenter asked if the "person subject to this paragraph" the same as "the submitter" and if "sites that receive a reportable substance from the submitter" are the sites that receive the substance from the submitter's site or from any of the submitter's
sites.

Source: C1-056

Response B.5a-7 : The paragraph from which the regulatory text is quoted was proposed as 40 CFR 710.32(c)(4). This paragraph pertains to additional information that must be reported for chemical substances manufactured in amounts of 300,000 lbs. or more in a reporting year at a single site. The “person subject to this paragraph” is the submitter, if the submitter is reporting information on a chemical substances whose production volume exceeds this 300,000 pound
threshold. Reporting under the IURA is required for each chemical manufactured or imported at a single site in quantities that exceed the reporting threshold. Because reporting is by site, the additional information required by 40 CFR 710.52(c)(4) should include data only on processing
and use of the chemical substances manufactured at that site. If a firm manufactures the same chemical substance at more than one location, the downstream information should pertain only to the chemical substance manufactured at the site for which the report is prepared.

b. Process or Use Codes

Comment B.5b-1 : One commenter stated that EPA should add processing through distillation, extracting, or refining as an additional processing category.

Source: C1-024

Response B.5b-1 : EPA is unable to add the suggested processing category since distillation, extraction, refining, and similar activities may result in the manufacture of a chemical substance. For instance, extracting a chemical from a mixture of chemicals results in the manufacture of a chemical, and, in that instance, is not considered processing.Page 57 of 159 c. Industrial Function Categories

Comment B.5c-1 : Commenters expressed concern about the industrial function categories (IFCs) to be reported by submitters that have plant sites at which 300,000 lbs. or more of a reportable chemical substance is manufactured (including imported). One commenter was concerned about the application of the IFCs to chemicals with multiple industrial uses. Another commenter suggested that the Agency provide submitters with a "free response" option if their IFC is not represented on Form U while the third comment stated that the IFCs selected by EPA are adequate. Another commenter found the industrial function codes to be extremely broad.

Source: C1-024, C1-047, C1-068

Response B.5c-1 : Submitters are required to report up to ten unique combinations of processing and use categories, IFCs, and NAICS codes (see section 710.52(c)(4)(i)(C) of the regulatory text). In making their selection from among the IFC codes, submitters must determine which IFC best represents the specific industrial use of the reportable chemical within a given NAICS code/processing and use category. The Agency will provide examples of how to select which code "best represents" an industrial use in the instruction manual that will be available to all submitters (see section 710.59 of the regulatory text). Submitters may report multiple IFCs for the same NAICS code, or multiple NAICS codes for each IFC. Unit II.F.7. of the final rule preamble provides further information on reporting industrial processing and use information. The set of IFCs adopted by EPA at section 710.52(c)(4)(i)(C) encompasses the vast majority of uses for chemicals subject to IUR repo rting. EPA did not include all IFCs or, as one commenter suggested, allow the submitter to supply an IFC not on the EPA list because the Agency wishes to limit the number of scenarios which must be analyzed for risk characterization. By aggregating similar uses under a single NAICS and a single IFC code, EPA will more effectively characterize the risk associated with the totality of the production of each chemical substance, especially for analysis at the screening level. By requiring the submitter to identify the appropriate IFC code from the provided list, EPA seeks to minimize the errors that could occur if the Agency, rather than the submitter, attempted to aggregate uses other than those identified in the prescribed list of IFCs.

Comment B.5c-2 : One commenter stated that EPA should clearly indicate how submitters should report when more than one type of industrial function category applies to a givenPage 58 of 159 processing or use activity.

Sources: C1-024

Response B.5c-2 : Submitters must provide industrial processing and use data for up to ten categories of industrial activity (by NAICS code). The Agency expects that far fewer than ten categories will be reported for most chemicals. For instances where more than one type of industrial function category applies to a given industrial activity/NAICS code combination, the submitter reports that combination multiple times, along with the associated industrial function category. Detailed instructions for filling out Form U along with examples will be provided in the instruction manual that will be made available to all submitters (see section 710.59 of the regulatory text for instructions on how to obtain a copy of this document).

d. Commercial and consumer product categories

Comment B.5d-1 : Commenters expressed different opinions about the consumer/commercial use categories in section 710.52(c)(4)(ii)(A) of the regulatory text (Part III, Section II of the Form U). One commenter felt that the EPA should adopt ("if and when these categories need to be delineated as part of any voluntary effort") the 41 use categories described in the European Commission Technical Support Document (EC’s TSD) 93/67/EEC Part III. Another commenter stated that the commercial and consumer use categories proposed appear to be adequate. A third commenter suggested that the "C-19 Other" category be deleted and that the Agency consider requiring the respondent to identify the specific use.

Source: C1-004, C1-065, C1-073

Response B.5d-1 : EPA is not changing the commercial and consumer product use categories at this time, although the Agency may revisit these categories in the future should a need arise for more specific commercial and consumer use information. EPA evaluated the EC’s categories and found that the EC’s set of use categories results in a more complex identification system than the one that will be used under the IURA b ecause it blends functional use information with end use information. For the screening level purposes of IURA data, EPA currently believes that focusing on end use information alone fo r commercial and consumer uses provides the necessary level of detail for its screening-level reviews. EPA additionally believes that the EC’sPage 59 of 159 scheme for commercial and consumer reporting would be overly burdensome (55 EC categories vs.19 IURA categories) and does not describe the commercial or consumer end uses in a way that meets the basic needs identified by EPA. For example, a chemical that is used as a propellant would be listed under the category "aerosol propellants" using the EC system. Such a listing would not provide the Agency with the information it needs,about the type of commercial/consumer product in which the submitter uses the propellant (e.g. paint, a lubricant, etc.). For more information on EPA’s commercial and consumer category analysis, see the document "Inventory Update Rule (IUR) Technical Support Document Selection of Consumer and Commercial End-Use Categories" (Final Draft, May 31, 1996) (Ref. 21). EPA w ill provide examples of the types of products that fit into its commercial and consumer product categories in the instruction manual that will be made available to all submitters (see section 710.59 of the regulatory text). EPA did consider requiring submitters to identify the specific use of the product as suggested by the commenter. However, the Agency decided to keep the "C-19 Other" category and continue to require submitters to choose from among the commercial and consumer product categories provided at section 710.52(c)(4)(ii)(A) of the regulatory text because it wishes to limit the number of scenarios which must be analyzed for risk characterization. Aggregating similar product categories will enable EPA to more effectively characterize the risk associated with the totality of the use of each chemical substance. By requiring the submitter to identify the appropriate product categories from the provided list, EPA seeks to minimize the errors that could occur if the Agency, rather than the submitter, attempted to aggregate uses other than those identified in the prescribed list of product categories.

Comment B.5d-2 : Commenters felt that the EPA should clarify that pesticides, drug and cosmetic end uses need not be reported under section 710.52(c)(4) of the IURA regulatory text. These uses fall under the jurisdictions of ot her Agencies/Offices, i.e., the Food and Drug Administration (FDA), EPA’s Office of Pesticide Program (OPP), FIFRA, and are outside the scope of TSCA. Other commenters suggested EPA provide a code for "Use not regulated by TSCA," both in the industrial function categories (section 710.52(c)(4)(i)(C) of the regulatory text) and in the commercial and consumer product categories (section 710.52(c)(4)(ii)(A) of the regulatory text).

Source: C1-018, C1-028, C1-031, C1-033, C1-056, C1-069, C1-073Page 60 of 159 Response B.5d-2 : EPA agrees that non-TSCA substances will continue to be exempt from reporting under IURA. Such substances are not within the jurisdiction of TSCA. Therefore, under IURA, amounts of an otherwise IUR-reportable substance that are intended at the time of manufacture or import to be used for non-TSCA purposes (e.g. as a pesticide, as a drug) will not have to be reported. This was also the case under the IUR in the past, prior to
these amendments. The Agency believes, however, that it does have the authority to require manufacturers (including importers) of TSCA chemicals to report downstream use information, for both TSCA and non-TSCA purposes although it has chosen not to exercise its authority at this time. Under IURA, submitters will be required to report only TSCA uses under sections 710.52(c)(4)(i)(C) and (c)(4)(ii)(A) of the regulatory text (Form U, Part III). Descriptions of industrial function categories have been clarified to reflect the fact that theyinclude only TSCA uses. For example, one of the industrial function categories is called "Agricultural chemicals (non-pesticidal)." The consumer and commercial product categories are also restricted to TSCA uses. For example, one of these categories is "L awn and garden products (non-pesticidal)." This category includes chemicals such as compressed gasses in delivery systems for many pesticides used indoors and outdoors, and other intermediates and inert chemicals. Additionally, many lawn amendments such as fertilizers contain chemicals that may be regulated under TSCA, (e.g., surfactants). See the instruction manual that will be made available to all submitters (see section 710.59 of the regulatory text) for further description of the various product categories.

Comment B.5d-3 : Commenters stated that chemicals used in articles should be exempt from the reporting of consumer and commercial end-use information (i.e. Part III., Section II. of Form U). Commenters believed that reporting should not apply to products which incorporate
manufactured chemicals into end use articles at the site of manufacture.

Source: C1-007, C1-012, C1-013, C1-018

Response B.5d-3: EPA disagrees with the commenters’ statements that exposures do not result from chemicals in articles. Therefore, EPA is not exempting manufacturers of chemicals that are later incorporated into articles from the reporting of consumer and commercial end-use information at this time. For example, potential dermal and inhalation exposures can result from chemicals incorporated into products in the commercial and consumer product category "fabrics, textiles and apparel." Specific cases, such as fo rmaldehyde from pressed wood products used inPage 61 of 159 mobile homes, show that potentially harmful exposures can occur from chemical components of
articles.

Comment B.5d-4 : One commenter felt that in the case of consumer products in particular, it is unclear whether percent production data and maximum concentration data in Part III., Section II. of Form U (the consumer and commercial information section) (sections 710.52(c)(4)(ii)(C) and (D) of the regulatory text) would add any material information to the production volume information already solicited under section 710.32(c)(3)(iv) of the regulatory text. The commenter stated that they already report the chemical volume manufactured or imported; therefore, there is no need to report it again with the consumer product information. The commenters believe that expanding the IUR requirements to include consumer and commercial information creates a reporting burden without serving a real interest. In addition, one commenter felt that reporting the maximum concentration of a chemical in commercial and consumer products "will create an exaggerated impression of potential exposure," especially when the chemical is in an article from which it is not expected to be released during use. Two commenters recommended dropping the maximum concentration data element from section 710.52(c)(4)(ii)(D) of the regulatory text to reduce the amount of reporting required.

Source: C1-007, C1-012, C1-018

Response B.5d-4 : EPA believes that percent production volume and maximum concentration information for chemicals with commercial and consumer uses will be extremely useful for risk screening purposes. Two examples of cases in which thes e elements could be used
are as follows:

1. Large volumes of a chemical are reported to be used in artists’ supplies, in products specifically intended for children, and at a significant concentration level. This IURA information would help EPA determine the potential exposure to children, and enable EPA to evaluate whether the development of toxicity information about that chemical is a priority. EPA could then evaluate and, if necessary, manage potential risks more effectively.

2. Reports show that a chemical serves as an absorbent in consumer paper products such as diapers and training pants and other products specifically intended for use by children orPage 62 of 159 in bladder control products used by the elderly, and that concentrations are potentially significant. The IURA would provide EPA with additional information, such as the fact that a large percentage of total production volume (of an absorbent) is dedicated to this single use (consumer paper products). This information could indicate that hazard data collection or development should be a priority activity. The Agency could then take the necessary steps to reduce the risk from this chemical to two of the most sensitive population groups--children and the elderly.

EPA is aware that the maximum concentration of a chemical in an article provides an upper bound on the concentration, and that the chemical may be present in articles at lower concentrations as well. The Agency will take this possibility into account when ut ilizing the
maximum concentration information it collects under IURA.

6. General Data Elements Comments

a. Workers "Reasonably Likely to be Exposed" to a Chemical Substance

Comment B.6a-1 : Commenters expressed a range of opinions on whether EPA should adopt OSHA’s definition of "employee" as EPA’s definition of a worker who is "reasonably likely to be exposed." One commenter stated that OSHA’s definition of an employee under its hazard communication standard, 29 CFR 1910.1200(c), is more appropriate for use in identifying persons reasonably likely to be exposed to chemical substances. One commenter stated that the Agency should broaden its definition of reasonably likely to be exposed in the IURA to include potential accidental or possible exposures to chemical substances which workers may experience in the course of their employment. Worker exposures in the "real world" include accidental or possible exposures, and that excluding some portion of those worker exposures, as EPA proposed, is inappropriate. Another commenter felt that persons who could be exposed to a chemical substance in foreseeable emergencies should be included in EPA’s new definition, while other commenters felt that OSHA’s definition is "overly broad." Yet another commenter called the Agency’s definition "adequate."

Source: C1-007, C1-011, C1-016, C1-020, C1-028, C1-044, C1-047, C1-051, C1-055, C1-065, C1-068Page 63 of 159 Response B.6a-1 : The OSHA hazard communication standard defines "employee" as a worker who may be exposed to hazardous chemicals under normal operating conditions or in foreseeable emergencies. Workers such as office workers or bank tellers who encounter hazardous chemicals only in non-routine, isolated instances are not covered. The Standard also defines "exposure" or "exposed" as the subjection of an employee to a hazardous chemical in the course of employment through any route of entry (inhalation, ingestion, skin contact or absorption, etc.) and includes potential (e.g. accidental or possible) exposure. EPA continues to believe that the OSHA definition of "employee" does not provide a more appropriate standard than the one proposed and finalized in the IURA. Whereas OSHA wanted to provide all workers who could forseeably be exposed to a chemical substance with knowledge of the potential hazards of that chemical, EPA is seeking to specifically identify those workers routinely exposed to chemical substances and for whom engineering controls and personal protective equipment are likely to provide the greatest benefit. The cumulative effect of small doses of a chemical substances over a long period of time is a greater risk to workers in areas where chemicals are processed than the unlikely catastrophic event which might also affect workers outside rooms where chemical processing occurs. The definition adopted by EPA for a worker "reasonably likely to be exposed" in this rule will target those individuals routinely exposed to chemical substances for whom chronic risks are greatest. This definition provides more useful and realistic information for the risk screening purposes for which IURA information will be used.

Comment B.6a-2 : A commenter does not understand how reporting the number of potentially exposed workers will aid the effort to protect workers. Other commenters stated that the route of exposure should be known in order to appropriately assess risk.

Source: C1-013, C1-020, C1-044

Response B.6a-2 : Collecting information on the number of potentially exposed workers will enable the EPA to develop screening level information regarding the types of potential exposures and the size of the exposed population. This information could be used to either support further investigation of worker protection issues or to allow the determination that no further investigation is warranted at that time. EPA agrees that the route of exposure is an important element in evaluating risk. The information collected by the IURA will provide preliminary data on the route of exposure through data elements such as the Physical Form Code (see section 710.52(c)(3)(viii) of the regulatoryPage 64 of 159 text) and the Industrial Function Category (see section 710.52(c)(4)(i)(C) of the regulatory text). The Agency has experience in determining routes of exposure based on these types of data elements. Two technical documents that support this rule, entitled ``Inventory Update Rule (IUR) Amendment Technical Support Document: Exposure-Related Data Useful for Chemical Risk Screening,'' and ``Preliminary Assessment Information Rule (PAIR) Database, Manufacturing Process Type/Release Analysis and Number of Workers/Production Quantity Analysis,'' describe the results of studies that demonstrate that information regarding the industrial sectors where a chemical substance is produced and used and information regarding the function that a chemical substance performs within industrial processes provide indications of the route, magnitude, and concentration of potential chemical exposures to the environment and to humans. Both documents can be found in the public record for this rulemaking.

Comment B.6a-3 : One commenter expressed concern that EPA may use IURA exposurerelated information to draw conclusions about exposure rates for the population at large.

Source: C1-020

Response B.6a-3 : The goal of the IURA is to provide a database of exposure related information which can be used for screening level purposes to identify chemicals for further assessment, as well as chemicals of lesser concern. EPA relies on this type of screening to indicate which chemical substances may pose a potential risk to human health or the environment, and thus warrant a more detailed, resource-intensive analysis. For example, EPA could use the IURA exposure-related information to identify sensitive and unprotected groups and inform them about potential health effects from certain chemical exposures. Therefore, EPA may use the IURA data to provide an indicator of general population exposure concerns, identifying the need for further investigation.

Comment B.6a-4 : Commenters stated that the highest reporting ranges for numbers of workers reasonably likely to be exposed are too broad, and that narrower ranges would provide more accurate estimates (see section 710.52(c)(3)(vi) of the regulatory text). Another commenter believes that the reporting burden could be reduced significantly if the lowest reporting range were changed from "Less than 10 workers" to "Less than 50 workers."

Source: C1-021, C1-033, C1-051Page 65 of 159 Response B.6a-4 : EPA selected the ranges provided in the IURA based on the expected uses of the information for basic chemical screening. The Agency believes that these ranges offer the optimum balance considering the level of data accuracy that is needed for basic screening-level exercises and the amount of submitter burden. While broader ranges may further reduce the submitter burden, the ranges would be too broad to be useful for screening and, while narrow ranges would likely provide more accurate estimates, that level of accuracy is not likely to be needed for the anticipated uses of the information. Additionally, range reporting is less burdensome for the submitter than calculating specific quantity estimates.

Comment B.6a-5 : Commenters expressed the view that reporting information about workers reasonably likely to be exposed to a reportable substance within the designated ranges (see section 710.52(c)(3)(vi) of the regulatory text) is inherently imprecise, requiring submitters to make estimates or "guess about employee exposure." Moreover, one commenter felt that requiring such judgments about the reasonable likelihood of exposures may expose submitters to significant TSCA liability for under-reporting, thereby forcing them to overestimate exposures. The commenter believes that these inaccurate figures could expose submitters to negative publicity and potential tort liability. In order to avoid these situations, the commenter states that submitters will need to assert and substantiate claims for CBI, further increasing administrative
burdens.

Source: C1-015, C1-017, C1-027, C1-031

Response B.6a-5 : Submitters should be able to reasonably ascertain information on the numbers of their own employees who are "reasonably likely to be exposed" at the reporting plant site (with respect to the requirement at section 710.52(c)(3)(vi) of the regulatory text), and should be able to readily obtain at least some information on the numbers of workers who are "reasonably likely to be exposed" at downstream plant sites (with respect to the requirement at section 710.52(c)(4)(i)(F) of the regulatory text). Submitters are being required to provide the information in ranges, not precise numbers, partly due to the fact that range information is less burdensome to compile than more specific information. Although range information is less precise than if EPA were to have required submitters to report the specific number of workers reasonably likely to be exposed to a chemical, the Agency’s view is that the ranges it has established under IURA are sufficient to provide information of the sort that can be used in basic,Page 66 of 159 screening-level exposure and risk determinations. Claiming CBI solely for the reasons described (i.e., to avoid negative publicity and potential civil liability) could constitute the intentional assertion of a legally invalid claim. The criteria which the commenter identifies are not recognized as criteria justifying confidential protection. The substantive criteria required to be met by claimants of confidential information
are found at 40 CFR 2.208.

Comment B.6a-6 : EPA should clarify that only workers employed by the reporting company should be counted among the workers who are "reasonably likely to be exposed."

Source: C1-011

Response B.6a-6 : With respect to the requirement at section 710.52(c)(3)(vi) of the regulatory text, the commenter is correct that only workers employed by the reporting site would be counted. With respect to the requirement at section 710.52(c)(4)(i)(F) of the regulatory text, an estimate must be provided of the number of workers reasonably likely to be exposed to a reportable chemical at the site(s) where the chemical is processed or used. This may include workers at the reporting site, as well as workers at other sites, whether or not these sites are owned by the company that owns the reporting site.

Comment B.6a-7: One commenter would like EPA to clarify that submitters are not expected to perform exposure monitoring or measuring to develop estimates of numbers of workers reasonably likely to be exposed.

Source: C1-018

Response B.6a-7: The IURA does not require submitters to conduct any new exposure monitoring or measuring activities to help them develop estimates of numbers of workers reasonably likely to be exposed, and it is not the Agency’s intent that submitters do any such monitoring or measuring for this purpose. Submitters should develop estimates based only on their existing knowledge and records of their operations.

Comment B.6a-8: Commenters requested that EPA issue guidance for submitters under the IURA to help them interpret the regulation and develop estimates of required data elements.Page 67 of 159 One commenter asked the Agency to issue the guidance document concurrent with the rulemaking process, not after, to provide opportunity for public comment.

Source: C1-027, C1-028

Response B.6a-8: The Agency will issue an instruction manual, called "Guidance Document: 2002 Reporting for Updating the Chemical Substances Inventory Database Under the Toxic Substances Control Act," to assist submitters with interpretation of the rule and their reporting. The document will be available from the EPA website ( www.epa.gov). Although EPA is not required to request public comment on the instruction manual, the Agency has used issues and ideas raised during the rulemaking comment period to develop the document. For each reporting cycle, the document will continue to be enhanced by adding additional examples or explanations, as needed, based upon comments received and reporting problems identified.

Comment B.6a-9 : Several commenters thought that EPA should define a minimum frequency and duration for exposure as part of the Agency’s definition of workers "reasonably likely to be exposed" to a chemical in order to help employers determine which workers need to be included in estimates associated with the requirements in sections 710.52(c)(3)(vi) and (c)(4)(i)(F) of the regulatory text. One commenter suggested that EPA should establish a de minimis concentration or other criterion under which a person is not deemed to be reasonably likely to be exposed. The commenter also stated that EPA has recognized in the past that exposures typically occur in intermittent bursts and spikes and as such these occurrences should be incorporated into the EPA definition of "reasonably likely to be exposed." The commenter adds that EPA issued a report on this topic in 64 Federal Register 69,530 (Dec. 13, 1999). Another commenter stated that EPA should provide examples of activities that result in/do not result in a worker’s being qualified as someone who is "reasonably likely to be exposed" to help clarify the definition of "reasonably likely to be exposed."

Source: C1-007, C1-011, C1-013, C1-016, C1-017, C1-021, C1-028, C1-032, C1-055

Response B.6a-9 : EPA has not identified a de minimis concentration level, or a minimum frequency and duration for exposure, that would be applicable to all chemicals reporting under the IURA. The concentration level would vary depending upon the specific chemical, the physical state of that chemical, and the route of exposure. It is not feasible to determine the appropriatePage 68 of 159 level for each chemical. The Agency has provided examples of activities which may lead to exposures of concern, such as charging reactor vessels; drumming; bulk loading; cleaning equipment; maintenance operations; materials handling and transfers; and analytical operations. Covered exposures include exposures through any route of entry (inhalation, ingestion, skin contact or absorption, etc.), but excludes accidental or theoretical exposures. The Agency's current methods of screening-level exposure analysis do not account for bursts and spikes such as accidental releases, sp ills, etc. Current risk assessment procedures are predicated on overall daily exposure levels and emphasize effects resulting from continuous exposure over a lifetime. Scientists now realize that exposures are more likely to be experienced as bursts or spikes, or intermittent exposures of varying levels. EPA's Risk Assessment Forum is beginning to examine how dose-duration relationships are or can be incorporated into the risk assessment process for less than life-time exposures. As part of this effort, the Forum and the Harvard School of Public Health held a workshop on August 5-6, 1998 to discuss the current understanding of dose-duration relationships, the approaches that can be used in their modeling, the inclusion of these relationships in risk assessment, and future efforts in this area. The final report, Summary of the U.S. EPA Workshop on the Relationship Between Exposure Duration and Toxicity (EPA/600/R-99/081, September 1999) is available on the Agency website at www.epa.gov/ncea/smdurto1.htm. At the initial screening level of analysis, estimates are based on exposures that could occur during activities that are routine in nature. Bursts and spikes are not generally included at this level of analysis, but more in-depth analyses are more likely to include them. More in-depth analyses will likely require information beyond that provided through IURA. In its definition for "reasonably likely to be exposed," EPA provides examples of activities that are likely to result in exposures that meet the definition to help submitters determine their need for reporting, i.e. "Such exposures would normally include, but would not be limited to, activities such as charging reactor vessels, drumming, bulk loading, cleaning equipment, maintenance operations, materials handling and transfers, and analytical operations." (See section 710.43 of the regulatory text). Employees reasonably likely to be exposed to a chemical are those who regularly and routinely monitor, sample, or transfer chemical substances or clean chemical process equipment. Employees who do not work near the location where chemicals are manufactured, processed, or used and who would be exposed to a chemical substance only in the unlikely event of a spill, release, or accident are not among employees reasonably likely to be exposed to the chemical substance.Page 69 of 159 Comment B.6a-10 : Commenters stated that, while they would be able to estimate the number of workers reasonably likely to be exposed to the chemicals they manufacture in response to section 710.52(c)(3)(vi) of the regulatory text, they have no way of knowing how many customers’ employees are exposed to their (the commenter’s) products in order to respond to section 710.52(c)(4)(i)(F) of the regulatory text. Commenters believed that their customers would not provide the needed information, and that it would be extremely time-consuming and labor-intensive for the commenter to attempt to estimate these figures. In a related comment, a commenter stated that worker exposure estimates it would develop for its customers would be extremely inaccurate.

Source: C1-015, C1-031, C1-068

Response B.6a-10 : The EPA does not expect nor require submitters to contact their customers for processing and use information in order to respond to the data elements in section 710.52(c)(4) of the regulatory text. Based on past experience (e.g. the New Chemicals program), EPA has found that submitters have some knowledge of processing and use information at their customers sites. EPA is requiring that submitters provide this processing and use information to the extent that it is readily obtainable

B if such data are not readily obtainable even in estimate form, a submitter is not required to respond to the data element. In the case of number of workers, submitters must indicate, with a code number/letter, in which range their customer sites fit. The ranges are sufficiently wide (eg., 25-50 workers, 100-500 workers) not to require submitters to develop specific numbers of workers using labor-intensive methods. Submitters are not required to gather information under IURA with respect to chemicals at their own plant sites that are not manufactured at/imported into their own plant sites. Submitters are only responsible for reporting information associated with chemicals that they, themselves, manufacture or import (see section 710.48 of the regulatory text). Therefore, if a submitter purchases a chemical fo r use but does not manufacture or import the chemical itself, the submitter has no IURA obligations with respect to that chemical.

b. Personal Protective Equipment

Comment B.6b-1 : A number of commenters expressed the opinion that EPA should not collect personal protective equipment (PPE) information for the purposes of risk screening. The type of PPE information that submitters would provide would be analogous to MSDS (MaterialPage 70 of 159 Safety Data Sheet) data. However, the commenters could support the collection of PPE data if EPA would allow submitters to use PPE as a way to submit lower estimates for various IURA data elements (i.e., lower number of exposed workers). Furthermore, commenters stated that there would be no meaningful way to differentiate an exposed worker from a worker who is not exposed with respect to PPE.

Source: C1-013, C1-016, C1-019, C1-032, C1-033, C1-047, C1-051, C1-055, C1-065,
C1-068

Response B.6b-1 : EPA agrees that collecting information on the availability of PPE is not critical to the initial risk screening process, and has determined that this data element should not be added to IUR as part of this rulemaking. Because EPA cannot ensure that protective equipment will be available to all employees and, if available, will be used properly in a well managed hygiene program, the risk encountered in the manufacture (including import), processing, or use of a chemical substance is initially assessed in the absence of PPE information. EPA does not intend to use PPE information to lower the estimates of workers reasonably likely to be exposed to a chemical.

Comment B.6b-2 : One commenter pointed out that the National Institute of Safety and Health (NIOSH) recommended the collection of PPE information. NIOSH stated that it is willing to assist in the development of a PPE usage questionnaire to eliminate any duplication of NIOSH
information collection activities.

Source: C1-065

Response B.6b-2 : EPA appreciates NIOSH’s offer to assist in the development of PPE usage questions. However, for the reasons stated in the response to comment B.6b-1, EPA does not intend to collect information on the availability of PPE. EPA may work with NIOSH in the future if it decides to develop PPE information for use in post-screening assessment activities.

c. Metric System Reporting

Comment B.6c-1 : Under the IUR, data are currently reported using the English system of measurement units. EPA requested comment on changing reporting requirements to substitutePage 71 of 159 the use of the English system for the use of the metric system. Two commenters suggested that EPA convert to Metric System Units. Another commenter requested that EPA continue requiring the use of the English System. Commenters also suggested giving submitters the option of reporting in either Metric or English Units.

Source: C1-031, C1-033, C1-047

Response B.6c-1 : EPA has decided, for now, to continue to require the use of the English system. This allows the IUR database to remain compatible with other Agency databases, especially TRI, which also most often use the English system. EPA believes giving submitters the option of reporting using either the English or metric systems of units would create confusion and increase reporting and administrative error. EPA may revisit this issue in future IUR
amendments.

d. Use volume accuracy and reliability

Comment B.6d-1 : Commenters stated that the accuracy and reliab ility of much of the information reported in Part III of the revised Form U would be highly questionable since it relates to sites, activities, and products that are not under the direct or indirect control of the reporting company.

Source: C1-028, C1-033, C1-038

Response B.6d-1 : EPA recognizes that submitters may not always have detailed information about how the chemical(s) they make are used. However, the Agency believes that most submitters have at least some basic information about downstream uses, such as the information that must be reported under IURA. In addition, EPA believes that the data will be of sufficient reliability for use by the Agency and others for purposes such as screening-level risk assessments and prioritization.

C. Reporting Universe Comments

1. Inorganic ChemicalsPage 72 of 159 a. Removal of the exemption for inorganic chemical substances

Comment C.1a-1 : Several commenters supported the removal of the inorganic chemicals exemption. One commenter stated that the Agency should never have exempted inorganic chemicals from IUR reporting in the first place.

Source: C1-047, C1-051, C1-064, C1-065

Response C.1a-1 : EPA agrees that the inorganic chemical substances exemption should be
removed.

b. Retention of the exemption for inorganic chemical substances

Comment C.1b-1 : A number of commenters stated that the reporting exemption for inorganic substances should be retained. They provided the following statements from EPA’s proposed rule (50 FR 9944, 9947, March 12, 1985) for the original IUR as reasons for retainingthe inorganic exemption: (1) the hazard potential of most inorganic chemicals is “relatively wellestablished,” (2) it was unlikely that EPA would use production volume for performing preliminary screening of inorganic chemicals in general, and (3), when additional data were needed, EPA could use the authority of a chemical-specific §8(a) rule to collect that information. Commenters stated that EPA has failed to provide a well reasoned and articulated rationale to change its long-standing position of exempting inorganics from the IUR.

Source: C1-010, C1-011, C1-013, C1-014, C1-015, C1-016, C1-019, C1-020, C1-026, C1-027, C1-028, C1-031, C1-032, C1-033, C1-037, C1-038, C1-040, C1-041, C1-042, C1-043, C1-044, C1-045, C1-050, C1-055, C1-060, C1-061, C1-069

Response C.1b-1: EPA is removing the inorganic chemical exemption to update the TSCA Inventory as required by TSCA §8 and to collect use and exposure-related information to enable EPA to screen these chemicals for potential exposures and risks. EPA originally devised the inorganic chemical exemption because it believed that the hazard potential of many inorganics was “relatively well-established” (50 FR 9944, 9947, March 12, 1985) and that information about these hazards was sufficient to prioritize concerns about inorganic chemicals, even without substantive exposure data or formal risk assessments. EPA now intends to increase thePage 73 of 159 consideration given to exposure, another component of risk, in screening chemicals and in setting priorities for risk assessment and risk management activities due to its belief that chemical hazard information alone is an insufficient basis for prioritization for these purposes. Additionally, EPA’s need for data has changed; the Agency is now evaluating and screening chemicals for new potential health effects such as endocrine disrupters as well as to evaluate potential health and safety risks to children. In the past, EPA made a prioritization decision not to update information on inorganic chemicals; however, EPA now believes that updated and additional information is necessary to make informed risk management decisions on inorganic chemicals. This exposure information is important to the Agency’s intent to screen risk, thereby increasing the importance of collecting and maintaining an exposure database for these chemicals. Thus, the change in inorganic reporting reflects a change in the emphasis placed on exposure in EPA risk assessments and screening activities. EPA relies on risk screening to determine which chemical substances pose a potential risk to human health or the environment, and thus warrant a more detailed, resource-intensive analysis, or risk assessment. An evaluation of potential “risk” is generally based on a combination of hazard information and exposure information. To the extent this information is complete and current, the preliminary determinations are more accurate. EPA intends to increase the consideration given to exposure in screening chemicals and in setting priorities for risk assessment as well as risk management activities, because chemical hazard information alone is proving increasingly insufficient for prioritizing risk. Exposure information, such as that expected under IURA reporting, is important to the Agency’s task of assessing risk, thereby increasing the importance of collecting and maintaining an exposure database for these chemicals. The EPA Science Advisory Board's report “Reducing Risk: Setting Priorities and Strategies for Environmental Protection” (Ref. 12) and the National Academy of Public Administration's report “Setting Priorities, Getting Results, A New Direction for EPA” (Ref. 13) recognize that EPA's ability to set priorities through risk screening and to allocate its limited resources has been significantly impeded by a lack of exposure data. The manufacturing, processing, and use of chemicals on the TSCA Inventory result in a wide array of exposure scenarios. 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, chemical substances that could pose an unreasonable risk to human health or to the environment or that otherwise warrant further investigation. The examples provided in comment C.1b-2, below, illustrate how important it is to havePage 74 of 159 the TSCA Inventory data for inorganic chemicals updated in the same way that organic chemical data are updated. Additionally, these examples illustrate that information on these chemicals does not exist in the public literature and why a chemical-by-chemical updating of the TSCA Inventory would not work. Information on just a few chemicals would not satisfy requests such as those for the HPV Challenge Program or for ITC purposes.

Comment C.1b-2 : Commenters stated that the Agency needs to demonstrate specifically how the data on inorganic substances will be used. A commenter stated that there is no indication that EPA is going to conduct risk screening on all inorganics. Some commenters stated that EPA had not demonstrated the practical utility of the inorganic exposure information, and that EPA was proposing the partial exemption only to get future use and exposure-related information.

Source: C1-011, C1-017, C1-019, C1-020, C1-027, C1-028, C1-033, C1-038, C1-040, C1-043, C1-044, C1-050, C1-055, C1-060

Response C.1b-2 : EPA will use this information in the same way as it will use the exposure-related information collected on organic chemicals. Although EPA may not develop full risk assessments for all inorganic chemical substances, information from all of the inorganic chemicals reported through the IURA will be used to conduct exposure and risk screening. The IURA data will assist EPA in prioritizing its resources and enabling EPA to focus on those chemicals, including inorganic chemicals, that present the greatest risk. Information collected through the IURA will populate an exposure database containing data on both organic and inorganic chemicals. This database will provide information to a wide variety of programs, including TSCA Existing Chemicals; Design for the Environment (DfE) (see http://www.epa.gov/opptintr/dfe); programs in other Federal agencies such as CPSC, OSHA, and NIOSH; and OECD programs. Additionally, the Agency will be able to compare chemicals based on varying potential exposure scenarios, and will be able to identify chemicals with similarities based upon manufacturing and use characteristics. For example, EPA will be able to identify chemicals with 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. EPA documented a variety of instances demonstrating where information on inorganic chemicals was needed to support the Agency’s mission and was not available. In a memo to OMB (April 20, 1999) (see docket OPPTS-82053), EPA states:Page 75 of 159 “Federal, State, local, and tribal governments are concerned about the risks these [inorganic] compounds may pose to society and its environment in contaminated drinking water, ground water, sediment, dredge & fill sl udge, mine tailings, fish, air, h azardous waste, work sites, and waste streams. Agencies such as EPA, OSHA, NIOSH, CPSC, and MSHA need information to identify the chemicals which potentially pose risks, but only EPA has the authority to obtain data of the type found on the TSCA chemical inventory. Most agencies rely on toxicology data in the open literature. When data are not available or are inadequate, most agencies must use their best judgement; this often results in the use of conservative estimates that may put an additional burden on the regulated community required to comply. In other cases, when there are inadequate or no data available, they may not have sufficient justification for taking actions that would be justified if adequate data were available. Both of these cases result in inefficiencies and unnecessary burdens.

Inorganic compounds are also the subjects for management decision-making, just like organic chemicals. Examples of decisions include: listing and delisting decisions, clean-up decisions, decisions setting standards for hazardous wastes, permitting, managing accidental releases, etc. EPA would use the inventory information to set priorities for developing data, including supporting findings necessary for obtaining test data, developing risk assessments and mitigating risks from inorganic chemical substances.”

EPA provided an example of using use information for an inorganic chemical, asbestos, in the proposal for the IURA. In the OMB memo, EPA presents several other examples identifying instances when even basic production information for inorganic chemicals, such as production volume, was needed and was not available:

In 1996, the Agency proposed a TSCA §4 test rule for Hazardous Air Pollutant (HAPs) chemicals. The proposal included three inorganic chemicals: chlorine, hydrogen fluoride, and hydrochloric acid. These are all very high production volume chemicals. Even for these very high production chemicals, EPA had problems finding the necessary information (on production volume and manufacturers) and had to make a number of assumptions based on the available information. This affected the Agency’s ability to make the decisions necessary to determine the impacts the HAPs proposal might have on the regulated community.Page 76 of 159 For the organic chemicals (18 of 21 chemicals), the Agency used IUR data to identify producers and their respective production volumes for assigning test costs in our analysis. For the inorganic chemicals, EPA obtained producer-level data from secondary sources--Mannsville or Chemical Marketing Reporter (CMR). In estimating test costs for producers identified through these secondary sources, EPA had to use capacity rather than production volume and had to assume that production would be proportional to capacity. Past experience shows that capacity is a poor proxy for actual production. The CMR information EPA was able to obtain for hydrochloric acid only identified manufacturers with a combined production capacity at all facilities of 100 million pounds or greater. Data on an estimated 23 producers with a combined capacity of 920 million pounds was
not available. • EPA is also developing a test rule to collect toxicity information on certain inorganic chemicals, primarily metals such as antimony, arsenic, beryllium, cadmium, chromium, cobalt, lead, manganese, mercury, nickel, selenium, tungsten and vanadium. EPA and others have found that both toxicity and exposure information is incomplete for assessing risks associated with these substances. The information collected through an amended IUR, including certain exposure-related information concerning the processing and use of each reportable chemical substance at sites controlled by the submitter and at “downstream” sites receiving the reportable chemical substance either directly or indirectly, would be combined with toxicity information, including the information collected through this test rule, to develop priorities based on potential risk concerns. Specifically, the required exposure-related information would include, to the extent the information is readily obtainable: the type of industrial processing or use at each site, including downstream sites; the North American Industrial Classification System (“NAICS”) codes that best describe the relevant industrial activities; the “industrial functions” of each chemical substance during processing or use for each NAICS code reported; the percentages of the submitter's production volume used in each industrial function category; the number of sites where the various processing and use operations occur; the number of workers reasonably likely to be exposed to the chemical substance in each operation; the categories of commercial and consumer uses of the reportable chemical substance; an indication of the presence of the reportable chemical substance in consumer products intended for use by children; the percentages of the submitter's production volume associated with each commercial and consumer product use category; and the maximum concentration of the reportable chemical substance in each commercial1 The ITC is an independent advisory committee to th e EPA Administrator that was created in 1976 under §4(e) of the Toxic Substances Control Act (TSCA). Sixteen (16) U.S. Government organizations are ITC Members, including the Agency for Toxic Substances and Disease Registry (ATSDR), Council on Environmental Quality (CEQ), Consumer Product Safety Commission (CPSC), Department of Agriculture (USDA), Department of Defense (DOD), Food and Drug Administration (FDA), Department of the Interior (DOI), EPA, Department of Commerce (DOC), National Cancer Institute (NCI), National Institute of Environmental Health Sciences (NIEHS), National Institute for Occupational Safety and Health (NIOSH), National Library of Medicine (NLM), National Science Foundation (NSF), National Toxicology Program (NTP) and Occupational Safety and Health Administration (OSHA).
Page 77 of 159 and consumer product use category. • The Interagency Testing Committee (ITC), comprised of representatives from 16 U.S. Government organizations 11 (including the EPA), is probably the most consistent and largest user of data produced from the IURs. The ITC’s dependence on production (and import) volume data and trends is well known and reflected in numerous strategies to identify chemicals and structurally-related classes of chemicals. With the exception of antimony compounds and organotins, the ITC routinely has to defer recommending large structurally-related classes of inorganic chemicals for testing or information reporting because of the lack of reliable production volume data. A recent example illustrates how the lack of data influences which chemicals and structurally-related classes of chemicals the ITC recommends for testing or information reporting. The ITC recommendation therefore affects which chemicals and structurally-related classes of chemicals are then assessed for exposure, hazard or risk. In September 1991, OSHA presented a list of 658 chemical substances and mixtures (its Z-1-A Table in 54 FR 2332-2983) to the ITC to assess the availab ility of dermal absorption data and the need for testing that could be recommended under TSCA. The ITC reviewed the list and determined that a number of polymers, pesticides, complex mixtures, and chlorofluorocarbons (CFCs) are not suitable candidates for consideration because they are not suitable for testing, they are regulated under other Federal authorities, or they are not regulated under TSCA. The remaining chemicals were divided into 2 groups based on production volume: greater or less than 1 million pounds, based on the 1990 IUR data. All inorganic chemicals and structurally-related classes of inorganic chemicals were assigned to the “less than 1 million pounds” group b ecause there were no IUR data. The ITC recommended 80 chemicals ( for which IUR data were available ) for dermal absorption testing in its 31st, 32nd and 35th Reports to the EPA Administrator. Chemicals which had no IUR data (including all of the inorganic chemicals) werePage 78 of 159 eliminated from this recommendation solely due to the fact that IUR data did not exist.

Additional discussion of uses for data on inorganic substances can be found in Unit III.A.1. of the preamble for the IURA final rule, the preamble to the proposal, the economic analysis, letters to OMB (placed in the public version of the official record for this rulemaking), and in the report “EPA Needs Exposure-RelatedData: A Discussion of the Justification for Collecting Exposure-Related Data Through the IUR Amendments.”

Comment C.1b-3 : Commenters did not think EPA’s proposed rule example demonstrating the need for information on inorganic chemicals (i.e. regarding the use of asbestos in building materials) justifies lifting the exemption for these chemicals under IURA. Additionally, a commenter pointed out that, since asbestos has been subject to a TSCA §6 rule, it was not previously exempt from IUR reporting and therefore it was inappropriate for EPA to use asbestos as an example for mandating IUR reporting for all inorganic chemicals.

Source: C1-010, C1-011, C1-014, C1-015, C1-020, C1-032, C1-040, C1-042, C1-044,
C1-055

Response C.1b-3 : In the preamble to the proposal (64 FR 46771, August 26, 1999), EPA stated that the Agency is increasing the “consideration given to exposure, another component of risk, in screening chemicals and in setting priorities for risk assessment and risk management
activities due to its belief that chemical hazard information alone is an insufficient basis for prioritization for these purposes.” EPA used asbe stos as an example of an inorganic chemical where the Agency has identified a need for downstream use information, despite the fact that asbestos is a well-studied and regulated chemical. Asbestos has been subject to basic IUR reporting in the past, due to the fact that, as an inorganic chemical regulated under TSCA §6, it did not qualify for the general exemption for inorganic chemicals. The fact that basic IUR data have been provided for asbestos in the past does not make this chemical a poor example of the current need for IURA data on inorganic chemicals, however. Additional examples of the needfor both basic IUR information (such as production volume information) and further exposurerelated information (such as the processing and use information that will be collected under IURA) are described earlier in comments A.1-1 and A.1-2 and were provided in the public version
of the official record.Page 79 of 159 Comment C.1b-4 : A commenter stated that, before an agency can reverse a settled course as EPA has done with regards to its treatment of inorganic chemical reporting under the IUR, it must consider reasonable alternatives to such reversal and provide a reasoned and detailed explanation of its reasons for rejecting those alternatives.

Source: C1-038

Response C.1b-4 : EPA did consider alternatives to the IURA as a means of collecting data on inorganic chemicals, and as a means of collecting exposure data. EPA considered using publicly available data, using voluntary surveys to collect the data, using PAIR rules to collect the needed data, and using a range of different amendments to the IUR to collect the data. Discussions of these alternatives can be found in the preamble to the proposal (64 FR 46771, August 26, 1999) and in the economic analysis for the proposal (“Economic Analysis of Proposed Amendments to the TSCA §8 Inventory Update Rule,” ref. 22). Further discussions are found in the preamble to the final rule and in the economic analysis for the final rule (“Revised Economic Analysis for the Amended Inventory Update Rule,” ref. 23). EPA based its consideration of using publicly available data on EPA’s experience with current data sources and a review of existing data sources to determine if that data would suffice to meet EPA’s needs. This review is presented in “A Review of Existing Exposure-Related Data Sources and Approaches to Screening Chemicals: A Response to CMA” (ref. 24). Overall, EPA was unable to identify a single data source, or a combination of data sources, which could provide the information EPA would collect through the IURA. As discussed in the preamble to the proposed rule, EPA had conducted a voluntary survey, called the Use and Exposure Information Project (UEIP), with the assistance of industry partners (the Chemical Manufacturers Association (CMA) (now the American Chemistry Council, or ACC), the Chemical Specialty Manufacturers Association (CSMA), the Synthetic Organic Chemical Manufacturers Association (SOCMA), and the American Petroleum Institute (API)). The UEIP was a cooperative effort begun in the fall of 1992 between government and industry in recognition of the difficulties encountered in obtaining accurate and up-to-date exposure information on TSCA chemicals. Information collected by EPA under the UEIP is similar to that being requested under the IURA and included the following: production volume, site location, percentage of production volume for a given use, environmental releases, number of workers, worker activities, monitoring data, and industrial and consumer uses. EPA's experience with UEIP has shown that the types of information requested by the UEIP can be used to preparePage 80 of 159 screening level exposure assessments, and that the data to prepare the assessments are available from industry. The UEIP, however, provided one-time reporting of information by a subset of the manufacturers of a small number of selected high production volume (HPV) chemicals. Given these efforts, the limitations of the data available from past and current information collections that are described in detail in the proposal (64 FR 46772, August 26,1999), and the amount of time it would take otherwise to acquire screening-level exposure data for the chemical substances on the Inventory, EPA believes it is appropriate to develop a more systematic and broadly applied approach to the prioritization process by requiring that new, key, additional exposure-related information be reported under this amended rule instead of collecting the information through a voluntary program. EPA also determined that PAIR was not a sufficient means of collecting the data needed to satisfy the purposes for amending the IUR. Further discussion of PAIR can be found in the responses to comment C.1d-4 below.

c. Phasing in reporting of inorganic chemical substances

Comment C.1c-1 : Commenters supported a phased-in approach to full reporting requirements for inorganics, stating that a phased-in approach would give affected entities time to get familiar with the IUR requirements. Another commenter s uggested using a tiered approach, beginning with partial reporting during the first year for a list of inorganics for which the Agency has specific needs or concerns, moving to full reporting for those inorganics during the second year and partial reporting for the remaining inorganics. One commenter affirmed the need for data on commercial and consumer use information for inorganic chemicals in assessing the potential risks from these products and requested the EPA require full reporting from the beginning.

Source: C1-047, C1-051, C1-064, C1-065

Response C.1c-1: EPA agrees with the comments supporting a phased-in approach and has adopted one for reporting information on inorganic chemicals. Phasing in reporting requirements provides new submitters with an opportunity to become familiar with basic IUR reporting, allows EPA to become familiar with the current inorganic chemical industry, and provides basic production information needed for programs such as those run by the Interagency Testing Committee (ITC). The tiered approach would not accomplish these goals, and would require the Agency to determine, without the basic information needed to make thatPage 81 of 159 determination, which inorganic chemicals are of most interest. Requiring full reporting by inorganic chemical manufacturers after the initial submission period (in which only basic IUR reporting would occur) will result in the collection of information needed to continue efforts begun with the first reporting year information, such as providing exposure related information needed to put HPV Challenge Program hazard information into context. EPA’s primary use of both the basic data collected during the first submission period and the additional exposure related data collected during subsequent submission periods will be to identify priority chemicals for more detailed information gathering, risk assessment, and risk management. Screening chemical risks generally requires a combination of both hazard and exposure information. The absence of exposure related data, beyond even the basic production data collected during the first submission period under the IURA, would severely limit EPA’s ability to conduct efficient, effective risk screening.

Comment C.1c-2 : Some commenters suggested EPA review the information collected on inorganic chemicals from the partial exemption. If warranted, EPA could then collect additional information on these chemicals through a separate IUR amendment. Additionally, a commenter stated that full reporting for inorganics should only be instituted after further assessment of basic reporting information. Another commenter suggested the Agency demonstrate the benefits of the processing and use information on organic chemical substances before considering inorganic chemical reporting.

Source: C1-003, C1-017, C1-043

Response C.1c-2 : EPA believes that there is no compelling rationale for treating inorganic chemicals differently than organic chemicals, which the commenters are suggesting by stating that EPA review the basic manufacturing information before extending the collection to processing and use information, or by demonstrating the benefits of processing and use information on organic chemicals before collecting such information on inorganic chemicals. EPA proposed a partial exemption for inorganics for two basic reasons. First, EPA wanted to allow the inorganic industry to become familiar with reporting under the IURA before requiring full reporting. Second, EPA can begin work on issues associated with inorganics with the basic manufacturing information that will be collected during the first submission period. EPA currently does not have access to this type of information on inorganic chemicals. The phased-in approach being used forPage 82 of 159 collected inorganic chemical information accomplishes these two goals, while ensuring that the Agency and others will have needed exposure-related information on inorganic chemicals in a more timely manner than would be possible were the Agency to go through another rulemaking to extend the collection of processing and use information to inorganic chemicals, as the commenter has suggested. Justification for collecting the additional exposure information on inorganic chemicals is provided in the response to comment C.1b-3.

d. Alternatives for reporting of inorganic chemical substances

Comment C.1d-1 : EPA should focus on specific inorganics of potential concern, based upon known information about their toxicity, the types of uses that may be of potential concern, or any other aspect of risk that may already be known. Elimination of the exclusion could result in reporting for common substances such as water and sodium hydroxide, and for other substances for which IUR reporting would have no value. Commenters stated that EPA should simply list the CAS numbers of the inorganic chemicals for which it requires partial reports in any given IUR reporting period, or promulgate chemical-specific §8(a) rules. This approach would allow EPA to collect data for those inorganic substances for which it actually is ready to perform screening and prioritizing (i.e., gather data on a case-by-case basis). Alternatively, the Agency could review the information collected on inorganic chemicals from the partial exemption and collect additional information on these chemicals by specifically listing chemicals for future IUR
collections.

Source: C1-011, C1-015, C1-017, C1-019, C1-020, C1-027, C1-028, C1-033, C1-038, C1-041, C1-043, C1-044, C1-060

Response C.1d-1: EPA has a need for a broad-based source of screening level use and exposure information on inorganic chemicals. The Agency does not have the information needed to determine which inorganic chemicals are of potential concern. In fact, one of the primary uses of the IURA information is to determine on which chemicals EPA and others should be focusing. Data collected through the IURA will be screened to determine which chemicals potentially have exposures of concern or, when combined with other information such as hazard data, to determine which chemicals potentially have risks of concern. 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 prio rities for conducting further analyses, includingPage 83 of 159 hazard testing, risk assessment, and risk management. The Agency does not believe that hazard is an appropriate factor for limiting the collection of this data. Rather, this basic information on exposure and use will provide the necessary information to allow the Agency to consider available hazard information in the context of potential risk. Restricting the chemicals for which data are collected reduces the effectiveness of this screening tool and therefore the effectiveness and efficiency of various risk management programs. However, EPA does believe that there are certain chemicals for which it has a low current interest in the processing and use information collected through the IURA. EPA provides a specific list of those chemicals, and they are exempted from reporting the processing and use information [see 710.46(b)(2) of the regulatory text]. As interest in the IURA processing and use information for a specific chemical can change, this list of chemicals can also change; a list revision process has been established so the public can request changes. This partial exemption and the list revision process is further described in the preamble at Unit II.F.1.d. and in the Instructions Manual (Ref. 20). The development of the initial list of partially exempt chemicals in described in “Methodology Used for the Initial Selection of Chemicals for the Inventory Update Rule Amendments (IURA) ‘Low Current Interest’ Partial Reporting Exemption” (Ref. 25). There are other reasons for collecting this information through the IURA. After the first few collections there will be time series data with which to identify trends. Additionally, this information is unique from the aspect that it contains CBI. Although it may appear that similar data is available, this is not the case. Specifically targeting chemicals undermines many of EPA’s reasons for collecting exposure related information on inorganic chemicals. 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 identify future issues associated with inorganic
chemicals. In addition to the partial exemption described at the beginning of this response, EPA has focused the IUR amendments in two ways that affect the reporting of inorganic chemicals. First, EPA raised the reporting threshold from 10,000 lbs. to 25,000 lbs. Second, EPA instituted a second reporting threshold of 300,000 lbs. for the reporting of processing and use information. Naturally occurring chemicals, defined in 40 CFR 710.4(b)(1), remain exempt from reporting.Page 84 of 159 EPA disagrees with the suggestion to use the first year reporting data to choose specific chemicals on which to collect processing and use information. In addition to the reasons given above, the Agency found that, for organic chemicals currently reporting, the chemicals change about 30% each reporting cycle. This turnover in substances indicates that the chemical industry is dynamic and that a delay of four years in gathering information on chemicals is significant. Since the Agency is collecting this information to prioritize chemicals using a relative ranking basis, EPA needs to compare the chemicals and therefore needs comparable information collected at the same time. The Agency will then determine which chemicals are more likely to pose exposure or risk concerns.

Comment C.1d-2 : Commenters suggested using a hazard or exposure level for establishing which inorganic chemicals would be subject to IURA reporting. A commenter stated that inorganics, as a category, have limited h azard potential. A commenter stated that, for many chemicals, such as aluminas, naturally occurring clays, and zeolites, hazards are relatively low.

Source: C1-019, C1-038

Response C.1d-2 : The Agency disagrees that a hazard or an exposure level for establishing reporting is appropriate. The Agency believes that hazards are not well established for all inorganic substances and disagrees with the statement that inorganics have limited h azard potential. Mercury selenide (HgSe) (CASRN 20601-83-6) and gallium arsenide (GaAs)(CASRN 1303-00-0) are examples of inorganic substances that could possibly harm the environment due to either hazard potential or unknown hazards. Any evaluation of potential “risk” is generally based on a combination of hazard information and exposure information; choosing just one as the criteria for reporting would not provide sufficient information to satisfy EPA’s expected uses of this information, as described earlier in the response to comment C.1b-2. EPA relies on risk screening to indicate which chemical substances pose a potential risk to human health or the environment, and thus warrant a more detailed, resource-intensive analysis. Although the inherent hazard associated with a chemical substance w ill often remain the same over time, exposure to workers and affected populations can change significantly. If the amount of a chemical substance produced increases significantly, releases to the environment and human exposures would also be expected to increase. Conversely, if the amount produced remains constant, environmental releases and human exposures may decline as engineering controls are added and pollution prevention practices are implemented. Although the hazardPage 85 of 159 associated with a chemical generally remains constant, the risk associated with the manufacturing, processing, and use of a chemical substance will change as exposure increases or decreases. Chemicals that present low hazard may st ill pose a risk if they have high exposures or involve exposures to particularly sensitive subpopulations. Naturally occurring chemical substances, both organic and inorganic, remain exempt from reporting under the IURA. See 40 CFR 710.4(b)(1)) for the definition of naturally occurring.

Comment C.1d-3 : Commenters stated that EPA should use existing information for inorganic chemicals, stating that the data (especially production volume data) EPA needs to conduct screening-level risk assessments are already available from a variety of sources. Commenters highlighted the U.S. Geological Survey (USGS) as a source of data. Commenters also listed the following potential sources of information: Toxics Release Inventory (TRI), data sources maintained by the Agency for Toxic Substances and Disease Registry (ATSDR) and the National Toxicology Program (NTP), EPCRA Tier II, material safety data sheets (MSDS), Bureau of Mines, Bureau of Labor Statistics, Census of Manufacturers, and the International Agency for Research on Cancer (IARC) monographs. The Agency should fully explore all sources of inorganic chemical information before collecting more.

Source: C1-010, C1-016, C1-019, C1-032, C1-033, C1-038, C1-042, C1-043, C1-053, C1-055, C1-060, C1-067

Response C.1d-3 : The Agency has evaluated data sources that could potentially provide the accurate and up-to-date information it needs, including the data sources suggested by commenters. These data sources are discussed in the following documents: “Inventory Update Rule (IUR) Amendments Technical Support Document: Exposure Related Data Useful for Chemical Risk Screening” (Ref. 16), “Economic Analysis of Proposed Amendments to the TSCA §8 Inventory Update Rule” (Ref. 22) and “A Review of Existing Exposure-Related Data Sources and Approaches to Screening Chemicals: A Response to CMA”(Ref. 24). EPA believes the decision not to utilize an alternate data source as a replacement for amending the IUR is still confirmed by the Agency’s support documents. A primary consideration, as mandated by TSCA, was to not subject industry to unnecessary or duplicative reporting. EPA currently does not have access to the exposure information sought under the IURA. Although some useful exposure related data exist in some sources, the data are insufficient typically due to a lack of currency and detail. Without thePage 86 of 159 IURA, EPA has difficulty efficiently screening potential risks posed by a large number of chemicals on the TSCA Inventory. Additionally, EPA reexamined the information included in the data sources specifically mentioned by commenters and found nothing to change the Agency’s conclusion that the information they contain would not fulfill EPA’s purposes for adding reporting on inorganic chemical manufacturing, processing, and use to the IUR. Some data sources pertained to naturally occurring substances which are excluded from the inventory by 40 CFR 710.4(b). Many of the remaining data sources identified by commenters pertained to metallic alloys or studies of a single metal species and did not include information on the multiplicity of pigments, flocculating agents, oxidants, photochromic salts, flame retardants, catalysts, and other inorganic compounds for which data is sought through the IURA. In some cases, the data sources were one-time collections of information and therefore would not provide current information on the inorganic chemical industries. Others, although revised from time to time, did not identify the chemicals with sufficient specificity, did not identify the manufacturing site or a technical contact, and/or did not provide information on the use of the inorganic chemical. In sum, the data sources identified by commenters and by EPA are not sufficient to provide the information sought through the IURA. Additional discussion of the applicability of the data sources is found in “Inorganic Chemicals: Sources of Information Suggested by Commenters to the Proposed Inventory Update Rule Amendments” (Ref. 26). One source suggested by commenters was the USGS mineral summaries. The USGS Mineral Commodity Summaries provide annual information on the total production of a chemical, in thousands of metric tons, in the United States. This information is presented in aggregate and it is not broken down by site; in contrast, the IURA requires this information for each site required to report under the rule. Similarly, the USGS Mineral Industry Surveys provide data on total production, imports, and consumption of each chemical. However, this information is also presented as an aggregate and would not be of us e for site-specific information, does not contain specific location information, does not indicate a tie-in to any parent company, and does not contain a certification of accuracy of the information. Both of these reports provide information on broad chemical categories such as a certain metal and its compounds. In such a USGS category, how many and which different inorganic chemicals are currently manufactured and
distributed in commerce cannot be identified. Users of these sources also cannot determine if the USGS reports include organic substances such as tetramethyl lead and tetraethyl lead among the metal compounds. Additionally, USGS data does not contain the other exposure information collected by the IURA, including certain manufacturing, processing, or use information. ThePage 87 of 159 USGS data varies widely from chemical to chemical; there is no consistency in the type of information contained in these summaries. Therefore, USGS data would not be adequate substitutes for IURA reporting. Production volume alone provides only a very rough idea of potential exposure. EPA did investigate with USGS the possibilities of collecting IURA-like information through the USGS voluntary reporting process. USGS participated in this investigation, but determined that using USGS to collect this information was not a viable option due to the wide variation in data collected, the differences in the entities from whom we collect information, the nature of a voluntary collection, and some legal challenges associated with USGS sharing information with EPA. (Ref. 27) EPA disagrees with the statement that available public information is sufficient to fulfill EPA’s purposes for collecting information on inorganic chemicals through the IURA. EPA is in a unique position to collect this data using TSCA. TSCA data are secured by regulation directly from market participants. Market participants, the regulated community entities, are required to provide the requested information. Sensitive and confidential information is protected by statute and must be provided. In contrast, other information collection authorities may rely on surveys, on literature searches, or on the voluntary responses of entities to queries. Some information may be sensitive or confidential and therefore the survey participant may find it inappropriate to reveal it. Literature searches are necessarily limited b ecause they only capture information actually in literature and that literature suffers the same flaws as surveys, queries, etc. In short, data
collected under the IURA is more reliable than the data available from other sources.

Comment C.1d-4 : Commenters stated that, if EPA were to have specific concerns for substances or categories, the selective use of TSCA Preliminary Assessment Information Reporting (PAIR) (40 CFR part 712) reporting would be more cost effective than requiring all manufacturers exceeding a production trigger to report production, use, and exposure information. This approach would allow EPA to collect data for those inorganic substances for which it actually is ready to perform screening and prioritizing (i.e., gather data on a case-by-case basis).

Source: C1-011, C1-015, C1-017, C1-020, C1-027, C1-028, C1-033, C1-038, C1-041, C1-043, C1-044, C1-060

Response C.1d-4 : While the Agency agrees that PAIR is an effective and useful tool forPage 88 of 159 collecting information on specific chemicals or small groups of chemicals, chemical specific collections of data will not fulfill the Agency’s reasons for collecting the IURA inorganic information (see the discussion in the response to comment C.1b-1). Use of PAIR in this manner implies that EPA should continue to set risk screening priorities based on hazard and production volume alone, or in response to requests from others. As discussed in the document entitled “A Review of Existing Exposure-Related Data Sources and Approaches to Screening Chemicals: A Response To CMA,” (Ref. 24) this approach greatly hinders EPA’s ability to make effective and efficient risk management decisions. The response to comment A.3-1 contains a further discussion of reporting under PAIR.

e. Specific inorganic chemical substances and industries

Comment C.1e-1 : Commenters requested that EPA clarify whether mining is considered "manufacturing" under TSCA. They argued that common references such as the NAICS system and a dictionary definition indicate that the term manufacturing does not include mining activities. In addition, they suggested that EPA exclude mined materials from IUR reporting requirements, arguing that the category for naturally occurring substances should include substances that are produced by mining operations. According to one commenter, if EPA were to require reporting by everyone who removes more than 25,000 pounds of material from the ground, this would result in a huge number of new reporting entities. For example, one large truckload of sand, rocks, or topsoil weighs well over the production volume trigger.

Source: C1-008, C1-014, C1-053, C1-054, C1-067

Response C.1e-1 : Mining, such as extracting metal ore or minerals from their natural deposits by any means, including the secondary recovery of metal ore from reuse or other storage piles, wastes, or rock dumps, or from mill tailings derived from the mining, cleaning, or concentration of metal ores, is considered "manufacturing" for commercial purposes within the scope of TSCA. However, chemical substances which are naturally occurring and which, among other things, are (i) unprocessed or (ii) processed only by manual, mechanical, or gravitational means (see 40 CFR 710.4(b)(1)) are currently excluded from IUR reporting and would continue to be excluded under these IUR amendments. For example, rocks, ores, and minerals would not be IUR-reportable to the extent they are manufactured only via the means described in 40 CFR 710.4(b). The §710.4(b) exclusion is a process specific exclusion rather than a chemical specificPage 89 of 159 one, therefore persons who manufacture a substance in a manner other than as specified in §710.4(b) are required to report under IUR unless they or the substance they manufacture are otherwise excluded. As a result, many mined materials are listed on the TSCA Inventory because at least some of the time they are produced by "non-natural" means.

Comment C.1e-2 : One commenter identified multiple counting problems for mined materials, and suggested that these materials would be reported under IURA when they are mined, when they are processed or manufactured on site, and when they are remanufactured due to recycling efforts.

Source: C1-016, C1-026

Response C.1e-2 : EPA disagrees that there is such a multiple counting problem for mined materials. It is true that, to the extent that mined materials undergo processes that result in the materials no longer being considered “naturally occurring” (see 40 CFR 710.4(b) and 40 CFR 710.46(a)(3)), they would have to be reported under IURA. However, with respect to certain “remanufacturing activities” due to recycling efforts, these are often considered by the Agency to be processing rather than manufacturing activities. “Process” is defined in 40 CFR 710.3 as the preparation of a chemical substance or mixture, after its manufacture, for distribution in commerce (1) in the same form or physical state as, or in a different form or physical state from, that in which it was received by the person so preparing such substance or mixture, or (2) as part of a mixture or article containing the chemical substance or mixture. In applying this definition to a “remanufacturing” situation, a person reclaiming lead from batteries by operations including melting down the lead is a processor, not a manufacturer. Therefore, the reclaimed lead is not subject to the IUR reporting requirements, assuming the person does not generate new amounts of lead through a chemical reaction or other method that falls outside the “process” definition. If any lead were to be generated via chemical reaction or other non-processing method, such as by reducing lead salts, that lead would be considered to have been manufactured and would be IURA reportable.

Comment C.1e-3 : Various commenters stated that either metals as a group, or various specific metals such as zinc and copper, should be granted special consideration for IURA reporting. Several commenters were concerned that information on average and maximum concentration is meaningless for the metals, since they will have close to 100 percentPage 90 of 159 concentrations when they leave the manufacturing site and when they are present in consumer or commercial products, and the only potential exposure will be dermal (not inhalation or ingestion). Additionally, a commenter felt that in the case of metals, workers “in proximity” to or handling solid metal articles should not be considered to be exposed for reporting purposes because the metal is in a form in which neither inhalation nor dermal exposure w ill occur. One commenter stated chemicals contained in “articles” should be exempted, such as metals used in coatings or alloys in steel and then used in products such as appliances or automobiles.

Source: C1-007, C1-014, C1-017, C1-021, C1-033, C1-038, C1-044, C1-054

Response C.1e-3 : EPA agrees that the metals present some unique issues regarding exposure potential. However, EPA does not agree that the information on the concentration of metals is meaningless. Not all products with metal constituents would contain a single metal, or would have metals forming 100 percent of the product. For example, although primary cobalt producers might manufacture cobalt strips or shot (pellets) at 100% concentration, downstream producers of pigments and paints could manufacture products of which cobalt is only some percentage of the total product, and present in a form (such as a paste or powder) where the metal could be released during processing or use, and to which workers or consumers could be exposed. Dermal exposure could be of concern for certain metals such as nickel, where contact dermatitis can occur from chronic exposure. For other metals, such as antimony and beryllium, inhalation exposure is a primary concern because of potential effects on the lungs. Ingestion exposure is of concern for metals, such as cadmium and chromium, that may be released to the environment and enter water sources. Although EPA is requiring the reporting of maximum concentration information under IURA for metals, the Agency has eliminated its proposed average concentration data element from the rule (see ). Although metals may be initially refined so as to be as pure as economically achievable, many metals, particularly more dense metals with toxic characteristics in the body, are reacted to form complex chemical substances. Examples include pigments containing lead, copper, cadmium, titanium, and chromium; catalysts containing nickel, manganese, vanadium, and palladium; and electronic and semiconductor materials containing lithium, antimony, arsenic, indium, and gallium. For chemical substances in which the amount of the metal may be only a few percent, the concentration of the metal and its compounds is an important factor is assessing the toxicity of the chemical substance and its dispersal and fate in the environment. EPA has exempted chemicals that would otherwise be subject to IUR reporting from suchPage 91 of 159 reporting where they are imported as part of an article (see 40 CFR 710.50(b)). Items such as metal ingots, billets, and blooms, however, are not considered articles b ecause the shape in which they are manufactured has no function in their end use, i.e., their shape is not maintained as an essential feature in the finished product (Ref. 28).

Comment C.1e-4: Commenters stated that they believed reporting on metals is unnecessary and an exemption for metals and metal byproducts should be retained. Commenters stated that ample information on metals production and exposure potentials is already available. The commenters state that zinc and copper can be found in dietary supplements and therefore cannot be harmful to human health. Some of these commenters suggested sources of information that may be duplicative of the information that would be collected on metals under IURA, such as the U.S. Geological Survey (USGS) or various trade associations. One commenter stated that the hazard potential for metals is well-established and in many cases concerns about exposure have already been addressed by federal and state laws and regulations.

Source: C1-016, C1-017, C1-019, C1-038, C1-044, C1-060

Response C.1e-4: The Agency reviewed a number of sources that provide information about metals production and characteristics, including the USGS data specifically noted by commenters. The information available through these sources, although useful for depicting global mining for and production of the major commercial metals, is not comparable to the national production scale and domestic exposures data that would be provided under the IURA. The response to comment C.1d-3, above, provides detail concerning EPA’s reexamination of the data sources noted by the commenters. For example, many commenters specifically mentioned the USGS Mineral Commodity Summaries (http://minerals.usgs.gov/minerals/pubs/mcs/) and Mineral Industry Surveys (http://minerals.usgs.gov/minerals/pubs/commodity/mis.html). The USGS Mineral Commodity Summaries provide annual information on the total production of a mineral, in thousands of metric tons, in the United States. This information is presented in aggregate and it is not broken down by site; in contrast, the TSCA Inventory Update Rule gathers this information for each site required to report under the Rule. S imilarly, the USGS Mineral Industry Surveys provide data on total production, imports, and consumption of each mineral.However, this information is also generally presented as an aggregate and does not provide sitespecific information, does not contain specific location information, does not indicate a tie-in to any parent company, and does not contain a certification of accuracy of the information, all ofPage 92 of 159 which will be provided under the IURA. Site-specific information is needed in order to determine the effect of manufacture and potential releases of the chemical to local environments, and to generate screening level estimates of potential exposures to workers. Additionally, site specific information increases the flexibility of the IURA data elements. It gives the Agency the freedom to aggregate the data in multiple ways to suit multiple analytical purposes, thereby significantly increasing the utility of the data. The USGS sources also do not provide information on specific metal substances, such as inorganic oxides, halides , or sulfates. As described in the response to comment C.1d-3, EPA did investigate with USGS the possibilities of collecting IURA-like information through the USGS voluntary reporting process. USGS participated in this investigation, but determined that using USGS to collect this information was not a viable option due to the wide variation in data collected, the differences in the entities from whom we collect information, the nature of a voluntary collection, and some legal challenges associated with USGS sharing information with EPA. (Ref. 27) Although EPA believes that the hazard potential for metals is relatively well established, EPA needs exposure information to screen these chemicals for potential risk. Risk is composed of both hazard and exposure. For instance, zinc, copper, and other metals found in trace amounts in dietary supplements are not inherently safe and may be toxic in amounts higher than the FDA’s Recommended Daily Allowance. As a result, information on the exposure potential associated with a particular metal is needed. Likewise, EPA and others are interested in the effect of metals on the environment, and not just the direct effect on human health. EPA acknowledges that Federal and state laws address some exposure issues associated with metals. However, many of the current laws address very specific issues, such as the release of a chemical into the environment, or the recycling or disposal of metal or metal-containing items or wastes. The IURA, which focuses on the manufacturing, processing and uses of metal or metal-containing products in commerce, develops a reporting system for obtaining current exposure-related information that can improve, augment, or validate Agency risk assessment or risk management activities. This information will allow EPA and other interested parties to identify changes in use patterns or areas of future potential concern, and to measure the effectiveness of Agency programs which stipulate controls on metal manufacture, process, and use. For instance, if the Agency institutes a program with the intent of reducing the use of a certain substance, IURA reporting can provide data to determine if production or use patterns of that substance are changing.

Comment C.1e-5 : A commenter stated that the hazard potential of aluminum and itsPage 93 of 159 related compounds continues to be well-established and ample data exist on its health and safety. OSHA has relied on available data to perform risk assessments and make risk management decisions, therefore enough information should be available to EPA to enable it to screen for risk. Non-fibrous aluminum oxide has been delisted from the Toxic Release Inventory. The commenter states that the Agency’s proposal to require IUR reporting for non-fibrous aluminum oxide ignores the Agency’s previous analysis of the hazard potential of this substance.

Source: C1-044

Response C.1e-5 : The Agency agrees that the hazard potentials of aluminum and its related compounds have been well-established, with substantive health and safety data available. However, the major issues surrounding the reporting of aluminum and related products under the IURA concern the possible exposure profiles of those chemicals in commerce, as well as the examination of potential risks from previously un reported uses of these substances. Chemicals with relatively moderate or even low hazard can pose harm to human health and/or the environment with enough exposure. OSHA is primarily concerned with occupational health risks and its risk assessments, based on available occupational exposure data and hazard information, focus on potential risks to workers. EPA's risk assessments are broader in scope and may include potential risks to the general population or consumers as well as workers; therefore, additional exposure-related data are needed and are being collected via IURA. Similarly, the available information on non-fibrous aluminum oxide would be augmented by IURA reporting regardless of any change or lack or change in the hazard data, because possible manufacturing, processing, and use-related exposures not reflected in available TRI data could be obtained. TRI listing decisions are based on hazard issues and not on exposure issues. Since risk is a combination of both hazard and exposure (i.e., low hazard and high exposure may lead to a risk level of concern), a decision to delist a chemical from TRI does not mean the Agency has not concern for potential risks associated with the
chemical.

Comment C.1e-6: Commenters stated that lead has been extensively studied and its hazard potential reviewed on a continuing basis under a variety of Federal programs, all providing voluminous data readily available to the public. EPA has already conducted and completed areview of lead in the environment (see 56 FR 22096 (May 13, 1991)) and has investigated leadbattery recycling issues. Exposure to lead is also covered under the Clean Air Act, the CleanPage 94 of 159 Water Act, the Safe Drinking Water Act, the Resource Conservation and Recovery Act, and the Comprehensive Environmental Response, Compensation, and Liability Act.

Source: C1-042, C1-050

Response C.1e-6 : EPA acknowledges that lead has been studied extensively and that lead is the subject of various Agency and other programs. These studies characterize the toxicity of lead, and a variety of associated programs have been developed to address lead hazards. However, the documents and program areas identified by commenters generally pertain to releases of lead into the environment, or recycling/disposal of lead-containing items or wastes. The IURA focuses on the manufacturing, processing and use of lead-containing items in commerce. The cited statutes, notably CWA, CAA, SDWA, RCRA, and CERCLA, generally authorize regulations that address the allowable emissions, contaminant levels, and control practices for lead or lead-containing wastes and contaminants. In contrast, the IURA develops a reporting system for obtaining current exposure-related information that can improve, augment, or validate Agency risk assessment or risk management activities. The fact that lead is a known hazard is a compe lling reason to track its future use and manufacture. This information will allow EPA and other interested parties to identify any changes in use patterns or areas of future potential concern, and to measure the effectiveness of Agency programs which stipulate controls on lead manufacture, import, and use. For instance, if the Agency institutes a program with the intent of reducing the use of a lead, IURA reporting can provide data to determine if production or use patterns of lead are changing.

Comment C.1e-7: A commenter stated that information on nickel and high nickel alloys is already collected by the USGS and the TRI program, and that sufficient information to conduct risk screening and priority setting for nickel are available. The commenter lists the following
documents as sources of information on Nickel: Health Assessment Document for Nickel and Nickel Compounds(EPA, 1986); Toxicological Profile for Nickeland associated updates (ATSDR, September 1997); Toxicological Review of Soluble Nickel Salts (Toxicology Excellence for Risk Assessment, 2000); and Occupational Exposure Limits Criteria Document for Nickel and Nickel Compounds(European Commission, Dec 24, 1996). The commenter also states that the Nickel Development Institute (NiDI), the major industry trade association, periodically issues data on intermediate and end-use applications of nickeland that ATSDR, the European Commission, and others have profiled the primary and secondary production and usesPage 95 of 159 of and exposures to nickel. Additionally, EPA has used these data to develop EPA’s Risk Screening Environmental Indicator (RSEI) values in OPPT. The commenter states that these RSEI values seem to be exactly what the Agency is seeking through the IURA.

Source: C1-007

Response C.1e-7 : EPA agrees that the sources cited by commenters contain useful information on the hazards of, and exposures to nickel. The Agency disagrees that the sources cited by commenters for nickel contain sufficient information to meet Agency risk screening needs, especially over time. The major goal of the IURA is to obtain current exposure-related information involving manufacturing, processing and uses of chemicals in commerce. Sample information on nickel, as well as other metals, from the USGS, ATSDR, and NiDI has been reviewed, and is either relatively general or does not provide current exposure data. For instance, the 1996 European Co mmission (EC) Occupational Exposure Limits Criteria Document for Nickel and Nickel Compounds, used to set occupational exposure limits for nickel and nickel compounds, is a comprehensive document which has several important weaknesses when considered in light of the IURA data. The EC report lacks the U.S. site-specific data necessary for EPA screening processes. More importantly, this report will gradually become out-of-date, as there are apparently no plans to update it. The abstract to the proceedings of the Nickel-Cobalt 97 International Symposium, also provided by the commenter, states that nickel’s versatility “makes it indispensable in applications as diverse as food preparation and handling, architecture, transportation, oil and gas production, chemicals processing, potable water treatment, gas turbines, and environmental protection. The longer term outlook for nickel is quite buoyant.” The summary concludes with “as we enter the twenty-first century, nickel, its steels and alloys should continue to be optimum material choices for service in tough environments and critical applications.” As with all chemicals, the uses of nickel are likely to grow and change in the future, thereby supporting the need for updated information on the uses of this commercially important chemical.
Sources such as the EPA and ATSDR documents focus on nickel hazards rather than exposures, unlike the IURA data. Although such information can be useful in developing RSEI values, these values do not fulfill all the needs expected to be met by the IURA. (See http://www.epa.gov/opptintr/rsei/ for information on RSEI) The RSEI project primarily uses emissions data, such as from TRI, to predict screening-level human health and ecological risks from environmental releases, whereas IURA submissions provide site specific, exposure-relatedPage 96 of 159 data on chemical manufacturing, processing, and use. The IURA data might be useful in supplementing the RSEI values, rather than considering these values as substitutes for IURA data. The IURA involves a reporting system for obtaining current exposure-related information that can improve, augment, or validate Agency risk screening or risk management activities. Because nickel is a known hazard, to its future use and manufacture should be monitored. This information will allow EPA and other interested parties to identify any changes in use patterns or areas of future potential concern, and to measure the effectiveness of Agency programs which regulate nickel manufacture, import, and use.Nickel alloys are not reportable under IUR because EPA considers alloys to be nonreportable mixtures. While manufacturers of individual metals and metal compounds have to report the metal manufactured, manufacturers of alloys may not need to report alloys. Further discussion of reportability of inorganic substances is found in Unit II.F.1.a.of the final rule preamble.

Comment C.1e-8 : A commenter representing color pigment manufacturers, who used to make products such as ceramic wares, requested that EPA explain what significant hazard the Agency has established for ceramic wares and related products in the marketplace. The commenter stated that compounds such as iron oxides and complex inorganic color pigments are extremely safe and pose no risk to humans or the environment.

Source: C1-026

Response C.1e-8 : EPA disagrees with the comment that inorganic color pigments pose no risk to humans or the environment. Some of the inorganic pigments used in these items contain heavy metals. Some, for example lead and zinc chromates, are possible human carcinogens. Some, such as calcium carbonate, kaolin, titanium oxide, and zinc, could present respiratory
hazards. Additionally, the International Agency for Research on Cancer (IARC) monograph on silica and silicates (i.e., major components of cer amic ware) indicates that dusts formed during manufacturing, processing or use of some ceramic ware are possible human carcinogens through inhalation (See World Health Organization (WHO) International Agency for Research on Cancer (IARC) Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans. Silica and Some Silicates. Volume 42, (1987)).Page 97 of 159 Comment C.1e-9 : A commenter suggested that collecting IURA information on the large number of salts in commerce will not provide any additional information of value. Salts are especially difficult to deal with in mixtures that are imported. There could have been many steps in the processing of substances that would lead to different salts being formed, for example, through neutralization. The actual salt formed may be inconsequential to the properties of the product. For example, if hydrochloric acid was neutralized using sodium hydroxide, would sodium chloride be reported or the acid and base used in the formulation?

Source: C1-061

Response C.1e-9 : EPA disagrees that information on salts will not be of value. the Agency believes that there are many inorganic substances, including salts, for which the hazards are not well established and where exposure pathways are not well understood. Although mixtures as defined in 40 CFR 710.3 are not reportable under IUR, the chemical substances of which a mixture is comprised are potentially reportable. If you manufacture the substances as part of a mixture, you must determine for each substance in the mixture whether the production volume was at least 25,000 lbs. S imilarly, if you import a mixture you must determine for each substance in the mixture whether its importation volume was at least 25,000 lbs. Note that a person who creates a mixture by combining existing substances (e.g. substances that the person purchased, but did not manufacture themselves) without a chemical reaction is not a manufacturer of those substances and therefore does not report those substances under IUR. If an acidic or basic substance is deliberately converted to a salt by neutralization, that constitutes manufacture for commercial purposes as a chemical substance per se, rather than processing. The resulting salt would consequently be reportable under IUR. For instance, a company that manufactures hydrochloric acid must potentially report under IUR, assuming the amount manufactured is 25,000 lbs. or more, etc. If the same company subsequently purchases sodium hydroxide for use in converting the hydrochloric acid into a salt via neutralization (which involves a chemical reaction), the company would also potentially be subject to IUR reporting for its manufacture of the salt (which is not a mixture).

Comment C.1e-10 : One commenter stated that its member companies would continue to rely on 40 CFR 710.26(d) (710.46(a)(3) of the new regulatory text), the exemption for naturally occurring substances, as the basis for a sodium chloride exemption from TSCA IUR requirements.Page 98 of 159 Source: C1-008

Response C.1e-10 : Sodium chloride, as an inorganic material, is subject to reporting except for that volume that meets the requirements of the definition for naturally occurring substances. Chemical substances which are naturally occurring and which, among other things, are (i) unprocessed or (ii) processed only by manual, mechanical, or gravitational means (see 40 CFR 710.4(b)(1)) are currently excluded from IUR reporting and continue to be excluded under IURA (see 40 CFR 710.46(a)(3)). For example, rocks, ores, and minerals are not IUR-reportable to the extent they are manufactured only via the means described in 40 CFR 710.4(b). The §710.4(b) exclusion is a process specific exclusion rather than a chemical or industry specific one, therefore persons who manufacture a substance in a manner other than as specified in §710.4(b) are required to report under IUR unless they or the substance they manufacture are otherwise excluded. As a result, sodium chloride is listed on the TSCA Inventory because at least some of the time it is produced by other than manual, mechanical, or gravitational means. Section 710.46(a)(3) intentionally exempts from IUR reporting any chemical substance which is isolated/removed from nature, for a commercial purpose, by any means listed in §710.4(b). It also exempts any other chemical substance derived or separated from the substance originally removed from nature, provided such derivation involved only the means specified in §710.4(b). For example, when using manual, mechanical, or gravitational processes to separate one or more substances from a naturally-occurring mixture, these isolated component substances are also considered naturally-occurring and excluded from reporting. However, any substance manufactured from a naturally occurring precursor substance via a chemical reaction is not considered naturally occurring and therefore, not excluded from reporting under §710.46(a)(3).

2. Natural Gas Exemption

Comment C.2-1 : Commenters expressed support for the full exemption for the six natural gas streams listed in the proposed IURA. These commenters recommended adding the following chemicals to the list of those being fully exempted: fuel oil#2, kerosene, natural gas condensate, liquefied natural gas, alkanes C4, methane, ethane, propane, normal butane, butane, isobutane, pentanes plus, pentane, isopentane, and hexane. The commenters stated that an exemption is warranted for these chemicals because DOE already requires annual and monthly reports containing the same information as requested by EPA. Commenters also believe that an exemption is warranted for these chemicals (they were specifically referring to ethane, butane,Page 99 of 159 propane, and methane) as they are similar in chemical composition to the six exempt streams, their chemical structure and identity remain the same throughout processing, a similar amount of data is available for these chemicals as for the exempt six chemicals, and these chemicals have a similar number of TSCA reports filed as the six exempt streams.

Source: C1-010, C1-015, C1-022, C1-027, C1-029, C1-040, C1-043, C1-048, C1-059

Response C.2-1 : EPA has retained the natural gas exemption as proposed. EPA has considered the issue of adding the other chemicals suggested. The Agency did not include methane, ethane, propane, butane, and other paraffinic hydrocarbons in the list of substances excluded from IURA reporting because they are not just isolated components of natural gas but are also chemical substances which can be produced from other source materials, chemical process streams, feedstocks, or reactants. Each of the six exempted natural gas chemicals is a UVCB substance where the name reflects the source (natural gas) and manufacturing process information. "UVCB" is a category defined by the Agency and CAS to consist of substances of unknown or variable composition, complex reaction products, or biological materials. Since a UVCB substance is not considered a mixture under TSCA, it is not viewed as equivalent to a blend of component chemicals, regardless of source. Additionally, there are no other sources for the six exempted substances and their chemical idenities are specific for that one source material, natural gas. These alkanes have significant uses in chemical manufacturing, including the production of ammonia and methanol from synthesis gas derived from methane, thermal cracking of ethane/propane mixtures to produce ethylene, and vapor-phase oxidation of n-butane to produce maleic anhydride. Although they are less toxic than other classes of hydrocarbons, these alkanes are asphyxiants and higher homologues are central nervous system depressants. In addition, liquid alkanes can remove oil from exposed skin and can cause dermatitis or pneumonia. In any case, all are discrete chemical substances for which processing and use information will be collected by the IURA. Through EPA’s own research and consultation with a Department of Energy(DOE) representative, the Agency determined that while some useful information for these chemicals is included in the DOE/Energy Information Administration’s(EIA) survey forms 64A, 810, and 816, the information available in those reports is insufficient for exposure or risk screening. Chemical substances are not sufficiently identified in the DOE reports for EPA purposes. For example, the chemical substances are identified by a name other than that used by EPA, are identified in broad categories, and are not identified by CAS number. DOE reports also do not contain informationPage 100 of 159 on the number of workers that are reasonably likely to be exposed to the chemicals nor information on maximum concentration. Downstream processing and use exposure information collected through the amended IUR for these chemicals will be valuable to EPA and others. Liquefied natural gas, which is a form of natural gas (CAS # 8006-61-9), is covered under the natural gas exemption. Liquefied natural gas is natural gas that has been liquefied by reducing its temperature to 111 degrees K at atmospheric pressure. It remains a liquid at 191 degrees K, when the atmospheric pressure is 4.64 MPa (or 673 psig). EPA considers that liquefied natural gas is the same chemical substance as natural gas. The fact that the physical state of a substance (e.g. gas, liquid) is different from the original state of that already reported substance does not cause the change of state to have to be reported under IURA. Thus, a person manufacturing liquefied natural gas through the use of natural gas as a raw material is considered a processor of a chemical substance (natural gas) and should not report liquefied natural gas for IUR reporting. In addition, as a result of the new natural gas exemption, if this submitter were also a manufacturer of natural gas, it would no longer be required to report on its manufacture of natural gas because that chemical is fully exempt from IUR reporting.

Comment C.2-2 : A commenter asked why natural gas is not already exempt from IUR reporting under the exemption for naturally occurring substances, i.e. what purpose does the separate exemption for certain forms of natural gas serve?

Source: C1-056

Response C.2-2 : The naturally occurring substances exemption covers chemical substances which are naturally occurring and which, among other things, are (i) unprocessed or (ii) processed only by manual, mechanical, or gravitational means (see 40 CFR 710.4(b)(1)). The exemption doesn’t cover substances that are manufactured by means other than those described above. Natural gas is only naturally occurring when it meets the definition of naturally occurring substances and is therefore not necessarily exempt from reporting under the current IUR. The IURA’s exemption for certain forms of natural gas, on the other hand, covers substances that have been manufactured by means other than those described in the naturally occurring substances exemption.

Comment C.2-3 : A commenter suggested exempting natural gas processing plants fromPage 101 of 159 IUR reporting.

Source: C1-027

Response C.2-3 : Because of its wide variation in composition, natural gas obtained at the wellhead is treated for safety, economic, or system and material compatibility reasons. Produced gas is usually saturated with water which is removed by passing over liquid or solid desiccants to preclude condensation and corrosion in transmission lines. Poisonous hydrogen sulfide is removed from natural gas to prevent corrosion in transmission lines and to recover elemental sulfur; common processes for removal include adsorption on iron sponge and extraction by ethanolamine solutions. Subsequent to separating and recovering acid gases from the raw natural gas, additional processing is required to convert the hydrogen sulfide to elemental sulfur; sulfur production from natural gas exceeds the volume produced by mining. Natural gas processing plants are not simple operations in which the constituents of natural gas are separated by simple physical processes but often are complex chemical processing facilities at which chemical substances are extracted from the produced gas by adsorption, chemical addition, and cryogenic separation with further refinement of chemical substances removed from natural gas to produce economic products. Because of the potential for risk posed by some constituents of raw natural gas and the potential for exposure to these constituents during processing and chemical transformation into economic products, natural gas processing plants have not been exempted from IUR reporting.

3. Petroleum Process Streams

Comment C.3-1 : A commenter stated that EPA could use the DOE data along with other supplemental information sources to generate the type of petroleum process stream information that the IURA proposed to collect. Several commenters also stated that the proposed IURA reporting would be duplicative of DOE reporting for certain chemicals, particularly fuel oil #2 and kerosene, and that EPA should therefore fully exempt them from reporting under IURA. Several persons commented that there is no need to collect exposure data for petroleum process stream manufacturing operations because physical hazards existing at many sites currently necessitate extensive safety precautions that limit worker exposure. A commenter stated that concentration data (both average and maximum concentration) for petroleum streams is too difficult to obtain. Another commenter stated processing and use information reported in Part III of the draft FormPage 102 of 159 U is not relevant to petroleum process streams. The commenter stated that “many of these are site-limited (i.e., do not leave the refinery), and thus the data in proposed Part III of Form U would not be relevant. In addition, streams that do leave the refinery site are incorporated into products for which exposure controls are routine and required. The flammable and/or combustible nature of the products requires special containment and handling, and other practices designed to minimize hazard and exposure. The Part III information, which does not account for any of these practices and safeguards, would not yield useful information regarding exposures for petroleum products.”

Source: C1-010, C1-027, C1-043, C1-047, C1-048

Response C.3-1 : EPA has exempted over 500 petroleum processing streams from reporting the processing and use information collected in Part III of Form U. The CAS numbers for the exempted petroleum processing streams are listed in §710.46(b)(1) of the regulatory text. EPA has investigated the information collection conducted by DOE/EIA forms 64A, 810, and 816 through its own research and consultation with a DOE representative. The Agency determined that chemical substances are not sufficiently identified for EPA’s purposes in the DOE reports. For example, many of the chemical substances in the DOE reports are identified by nomenclature other than that used by EPA, are identified in broad categories, and are not identified by CAS number. Many of the chemical names used by DOE are either generic or represent groups of chemicals. For example, distillate fuel oil, reported on EIA Form 810, may refer to several chemicals on the TSCA Inventory such as Fuel oil #2, Fuel oil #4, or Fuel oil #6. This lack of specific identifier information results in information which is not specific to a chemical, meaning the EPA and others cannot distinguish which information collected by DOE is attributable to which chemical. Correct identification is needed to attribute the appropriate hazard and physical and chemical properties to the petroleum stream. The DOE information also lacks important exposure components and identifiers that are necessary for exposure and risk screening activities. For example, the DOE information does not contain the number of workers reasonably likely to be exposed to a chemical or the maximum concentration of the chemical. In addition, it may be difficult to discern from the DOE data if a petroleum process stream is used as a solvent in a consumer product or as a combustible fuel. This is an important distinction because the likelihood of exposure to a petroleum process stream depends on its use. These data are needed elements that will fill a vital data gap in chemical risk screening. Manufacturing exposure related data (such as maximum concentration, number ofPage 103 of 159 workers reasonably likely to be exposed) for petroleum process stream chemicals are needed despite workplace safety precautions that may be in place at an individual site. As it is possible that methods used to handle and store petroleum streams diminish exposure, at this time EPA is only requiring partial IURA reporting. Partial IURA reporting includes site location and production volume information as well as worker exposure information that will enable the Agency to focus on those industries and uses of chemicals where the greatest risk exists. Concentration is an important variable to consider when estimating magnitude of potential exposures. EPA is not requiring reporting of average concentration and is requiring reporting of maximum concentration. Maximum concentration information is used in screening chemicals on the TSCA Inventory and in the review of Premanufacture Notices (PMNs) for new chemical substances required by §5 of TSCA. EPA does not intend for submitters to go to great lengths to report concentration information under IURA. 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 that 90% by weight) to indicate the maximum concentration of an IUR-reportable chemical in shipments leaving the submitter's site.

4. Other Chemical Categories

a. High Production Volume Chemicals

Comment C.4a-1 : Industry states that it is already providing EPA with sufficient toxicity data via the HPV Challenge Program, as well as exposure data through other voluntary programs (e.g. ICCA, UEIP). Providing screening-level exposure-related information via the IURA would be duplicative and unnecessary. Some commenters suggested that EPA should limit the IURA reporting requirements to HPV chemicals that are sponsored by industry under the HPV Challenge Program, while others suggested that EPA should limit IURA reporting requirements to HPV chemicals not sponsored by industry under the HPV Challenge Program. One commenter asked why the voluntary HPV Challenge Program can’t be modified to include screening-level exposure-related information, rather than collecting this information via IURA. Another commenter suggested reproposing the IURA in order to capture those high production volume chemicals for which HPV Challenge Program participants do not provide a risk assessment.

Source: C1-010, C1-013, C1-017, C1-018, C1-019, C1-027, C1-028, C1-029, C1-031, C1-033, C1-037, C1-041, C1-046, C1-048, C1-060, C1-061, C1-073Page 104 of 159 Response C.4a-1 : The Agency recognizes that certain 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 the IURA. The HPV Challenge Program centers on providing hazard data, whereas the focus of IURA is on gathering exposure-related information for chemicals in a wide range of industrial operations, including both manufacturing and downstream applications. Adding the collection of IURA exposure-related information to the HPV Challenge Program is not an option for several reasons. First, the HPV Challenge is limited in scope to only the chemicals included in the program, thus eliminating information from other chemicals. Second, the HPV program is a one-time collection of information and is therefore an effective way to collect hazard data, which doesn’t change. However, exposure does change as uses and technology changes and, therefore, a one-time collection does not provide the needed on-going information. Third, for the most part the HPV challenge is a voluntary program. EPA collected exposure information in a voluntary manner through the UEIP. As described in the response to comment A.3-4, the Agency found that a voluntary program for IURA information
would be insufficient. Similarly, other data collection efforts, such as those under the auspices of the OECD (Organization for Economic Cooperation and Development) and ICCA (International Council of Chemical Associations) concentrate on the development of hazard assessments, and might provide only a very small fraction of the exposure related data called for under IURA. The ICCA and OECD/SIDS (Screening Information Data Set) programs are international programs designed with a very different purpose than the amendments to the IUR. The goal of the ICCA Program is to feed chemical cases through the SIDS Program. The SIDS Program develops hazard information for these chemicals, which most likely does not change from year to year, thus supporting a one-time report. However, the IURA is designed to provide current exposure related information for risk screening and priority setting. EPA therefore maintains that its data reporting requirements under the IURA are justified. The effect of the reporting threshold for exposure related information of 300,000 lb/yr is to ensure that the majority of HPV chemicals will report processing and use information under the IURA, thereby limiting the information collection efforts to larger volume chemicals. Additionally, the reporting threshold approach is taken as opposed to listed specific chemicals since, before any particular reporting cycle, the Agency could not know definitively what chemicals are HPV substances. This is because production volumes can vary significantly,Page 105 of 159 especially over a four-year reporting cycle, and it is not uncommon for chemicals to rise above or fall below the HPV threshold each reporting cycle. The Agency does not consider it appropriate to require reporting of exposure data only from those who do not voluntarily provide exposure information through the HPV Challenge Program. As described in the response to comment A.3-4, EPA’s experience with the submission of exposure-related data under similar voluntary programs (e.g., the UEIP voluntary program) is that EPA cannot predict what information will be s upplied. Additionally, information submitted through the IUR is collected every four years, while information collected through a voluntary program such as the HPV Challenge Program is generally only submitted once. Exposure scenarios change over time, and information on exposures to chemicals needs to be renewed on a regular basis. A change in exposure information could affect the risk associated with that chemical. Chemicals that present low hazard may st ill pose a risk if they are produced in significant amounts, and they are released into the environment at high volumes and/or concentrations and result in exposures. EPA did develop a partial reporting exemption for certain chemical substances where the Agency has little interest in the IURA processing and use information for the listed substances. In compiling the initial list, EPA included chemicals examined through the HPV Challenge program, where the Agency determined that SIDS type hazard information was not of interest to the Agency. Further details can be found in “Methodology Used for the Initial Selection of Chemicals for the Inventory Update Rule Amendments (IURA) “Low Current Interest” Partial Reporting Exemption” (Ref. 25).

Comment C.4a-2 : Procter and Gamble commented that the Soap and Detergent Association (SDA) intends to develop exposure and risk data to use in combination with the information collected on SDA sponsored chemicals in the HPV Challenge Program. The SDA’s March 1999 HPV Challenge Program co mmitment letter was cited.

Source: C1-028

Response C.4a-2 : EPA commends the Soap and Detergent Association for its intent to develop exposure and risk data to be used in conjunction with certain of the HPV Challenge Program data. These data could provide a valuable source of exposure-related information on certain types of chemicals. However, unlike the more-limited, one-time reporting of exposure and risk data that may occur for some chemicals under the HPV Challenge Program, the IURA willPage 106 of 159 gather exposure-related information for a large number of chemicals in a wide range of industrial operations, including both manufacture and downstream applications.

Comment C.4a-3 : EPA should publish a list of chemicals subject to the new Form U Part III (processing and use information) reporting in advance of each IUR year. HPV determinations could be based on data gathered in the prior reporting cycle without loss of data.

Source: C1-007, C1-016, C1-047

Response C.4a-3 : To do as the commenter suggested would result in an 5-yr gap between identifying the HPV chemicals and actually getting exposure-related information on those chemicals. For instance, the first collection of data will occur in 2006, which is when the current list of HPV chemicals would be identified. The next reporting would occur in 2010, providing information which the Agency would be able to use starting in 2011. This delay in obtaining the processing and use information would not provide the data in a timely manner, thereby undermining the Agency’s screening efforts. Information collected through the IURA will be used by the Agency in a wide variety of ways, and on a basically daily basis, as described in
section A.1. of this document. Note that the 300,000 lbs. per site year threshold for the reporting of processing and use information under IURA is not equivalent to the 1,000,000 lbs. per year nationally aggregated threshold for determining which chemicals are HPV for a given IUR reporting year.

b. Low Priority Chemicals

Comment C.4b-1 : EPA should draft a list of chemicals that would be exempt from information collection under IURA. This list should be comprised of chemicals that have been previously determined to be of ‘low risk’ or chemicals for which there is a minimum amount of existing hazard/exposure data (e.g. OECD/SIDS chemicals). Chemicals that may qualify for this proposed ‘low risk’ exemption may be chemicals that have been excluded from the HPV program and/or chemicals that are regulated under other Federal authority (e.g. FIFRA, FDCA). Commenters also stated that EPA should substantiate the collection of exposure information using a toxicity screen, thereby allowing EPA to prioritize chemicals based on toxicity. One commenter stated that chemical substances such as foods, food additives and animal feeds are of such low hazard that the risks presented by those chemicals w ill not be significant. Other commentersPage 107 of 159 stated that EPA should continue to grant full exemptions to natural gas products, polymers, and microorganisms, and should exempt other substances, such as carbon dioxide (which is largely naturally-occurring) and other commonly used fossil fuels.

Source: C1-003, C1-010, C1-011, C1-015, C1-017, C1-018, C1-019, C1-024, C1-027, C1-028, C1-031, C1-032, C1-033, C1-043, C1-047, C1-059, C1-068

Response C.4b-1 : The Agency has a need for a broad-based database of exposure information. See the comment response in section A.1 of this document for a discussion of the Agency’s and other’s need for this data. Taking out chemicals that may present potential risks will skew the results of the screening process, providing potentially in accurate results of the relative exposure or risk potentials of various chemicals and exposure scenarios. However, there are a variety of exemptions and partial exemptions designed to better focus the information collection on those chemicals for which the Agency needs or has current interest for the IURA
information. EPA has created exemptions from IURA reporting for certain chemicals, in addition to those chemicals already exempt under current IUR requirements. Since its inception, the IUR has exempted from reporting chemical groups such as polymers. Additionally, amounts of a chemical manufactured at or imported into a site for a purpose covered by another statute (e.g., as a food additive, pesticide, etc.) have never been subject to IUR, and are not subject to IURA. Amounts of these chemicals that are manufactured or imported for TSCA purposes will be required to be reported under the IURA, unless subject to an exemption. Through the IURA, EPA has created an exemption for natural gas substances and a partial exemption for multi-chemical petroleum process streams. For the first year of reporting, inorganic chemicals are also partially exempt. As discussed in the IURA proposal, EPA considered developing a low priority exemption, but was unable to develop a satisfactory rationale for such an exemption. Therefore, EPA requested comment on the criteria the Agency might use to establish such an exemption and on the specific chemicals that would qualify for such an exemption (see 64 FR 46772, 46794). EPA received a variety of suggestions for additional groups of chemicals to exempt. However, as discussed in the preamble to the final rule and in specific comment summaries in this document, the exemptions were either too limiting (i.e., those associated with HPV) or there was not a satisfactory rationale for creating the exemption that clearly describes which specific chemicals are covered by the exemption in such a way that distinguishes these chemicals from those that are not covered by the exemption.Page 108 of 159 EPA developed a partial exemption for specifically listed chemicals for which the Agency has a low interest in the processing and use information. Based upon various considerations rather than criteria, this exemption allows the Agency to better target the IURA to collect processing and use information for those chemical substances for which it needs the information. In recognition that the Agency’s information needs change over time, the list of partially exempted chemicals can be changed. A petition process has been established which allows the public to provide information and suggest additions or deletions from the list. This exemption is described in the final rule preamble in Unit II.F.1.d. and in the regulatory text at 710.46(b)(2). The initial list of chemicals under this exemption was developed following the procedure in “Methodology Used for the Initial Selection of Chemicals for the Inventory Update Rule Amendments (IURA) “Low Current Interest” Partial Reporting Exemption” (Ref. 25). The IURA exemptions were not based on a finding of low hazard. They were based on a recognition that the current interest in IURA information on these substances is not as great at this time. The Agency disagrees that a hazard level for establishing reporting obligations under IURA is appropriate. There are many substances for which the hazards are not well established. Furthermore, EPA does not believe hazard alone is an appropriate method for screening risks or determining priorities. Although the hazard associated with a chemical generally remains constant, the risk associated with the manufacturing, processing, and use of a chemical substance will change as exposure increases or decreases. Chemicals that present low h azard may st ill pose a risk if they are produced in significant amounts and have high exposure potential or are released into the environment at high volumes and/or concentrations, or involve exposures to particularly sensitive subpopulations.

Comment C.4b-2 : Several commenters stated that EPA should eliminate low priority chemicals from reporting exposure-related information. According to these commenters, low priority chemicals are chemicals that EPA has already determined to be low priority through the TSCA Existing Chemicals program, the HPV Challenge Program, or other EPA initiatives. Collecting data on these chemicals would be of minimal use for risk screening purposes. A commenter stated that of the 2000 substances reviewed through EPA's Risk Management (RM) process within the TSCA Existing Chemicals Program, 85% required no risk management action. This benchmark suggests that expanding the IURA may not be a cost-effective approach when 85% of the substances would require no further action by the Agency, due to either low hazard or low exposure potentials. The commenter recommended that chemicals considered of low concern via the Existing Chemicals Program be exempt from reporting under IURA.Page 109 of 159 Source: C1-003, C1-011, C1-016, C1-024, C1-028, C1-032, C1-068

Response C.4b-2 : EPA agrees that there are chemicals for which EPA has a low current interest in the IURA processing and use information. As described in response C.4b-1, EPA developed a partial exemption for specifically listed chemicals, based upon considerations listed in the regulatory text at 710.46(b)(2) and described in the preamble in Unit II.F.1.d. The Agency developed an initial list of chemicals for this exemption (see Ref. 25 for further discussion). EPA intends to examine the IURA processing and use information needs for additional chemicals before the first reporting period in 2006. The Agency disagrees that low concern (as determined by previous assessments by the Existing Chemicals program) existing chemicals should be uniformly exempt from IURA reporting, for a number of reasons. First, historical records describing outcomes of the existing chemical review process (or “completed cases” documents) show that only about half of those chemicals subjected to review were actually dropped from the assessment process (“brought to closure”) after initial screening. Of those, about one-third were removed because of low hazard/exposure determinations, and the others removed due to action by another agency, low risk reduction potential, or later consideration in a subsequent review process. Therefore, a set of chemicals possibly exempt because of low hazard or exposure, as shown by initial screens in the Existing Chemicals Program, is actually much smaller than that identified by the commenter. Many of the chemicals reviewed through the Existing Chemicals program were examined in a specific context. For instance, the Agency reviewed chemicals considered to be paint strippers and reviewed the chemicals in relation to each other. The Agency did not review any other uses of the chemicals outside of paint stripping; any finding of potential risk or
recommendation for further action was based on the use of the chemicals in the one end use. EPA’s risk assessment activities are tiered and data dependent; as new data are available for those chemicals previously screened and dismissed as low hazard and/or exposure, those concern estimates can be revised. The Agency’s screening risk estimates are largely relative, and reflect the need to integrate mission with available resources. Therefore, exempting low concern RM chemicals from IURA reporting is not warranted at this time. However, EPA fully intends to screen data for all chemicals captured by the IURA. EPA has no way of knowing ahead of time which chemicals will require risk management action, which is why the data EPA will be collecting via the IURA are necessary. As updated exposure information becomes available, however, individual exemptions on a case by case basis might be possible.Page 110 of 159 Comment C.4b-3 : A commenter stated that polymer-encapsulated substances should be exempt from the reporting of processing and use information under the IURA because they are low exposure chemicals. Similarly, one commenter stated that the Agency’s treatment of such substances under Significant New Use Rules (SNUR s) implies that encapsulated substances are of little concern. The commenter indicated that SNUR requirements no longer apply when chemicals are secured within a polymer matrix.

Source: C1-046

Response C.4b-3 : Formulated products that are made when a polymer and other nonreactive additives such as antioxidants, colorants, stab ilizers, etc. are mixed without a chemical reaction are considered to be mixtures under TSCA. Importers of these products are not required to report under IUR with respect to the mixtures themselves, when viewed as whole entities. However, as stated in a note in 40 CFR 710.4(c)(2), although IUR reporting for mixtures is not required, IUR reporting is required for chemical substances that are imported as part of a mixture. Thus, each component in a mixture is itself a chemical substance reportable under the IURA if it is imported in amounts of 25,000 lbs. or more by a site in a year. Importers, like all other TSCA “manufacturers,” are responsible for determining whether their substances are subject to IUR reporting requirements. The commenter's understanding that when chemicals are secured within a polymer matrix, the SNUR requirements no longer apply, is inaccurate. There is no EPA policy in 40 CFR part 721 stating that when substances are encapsulated in a polymer matrix, that SNUR requirements no longer apply to them. Although chemicals incorporated into a polymer matrix are not subject to SNURs in certain limited circumstances, for example, when an individual SNUR specifically states that the SNUR requirements do not apply to such substances (see, e.g., 40 CFR 721.8160(a)), such chemicals are not otherwise generally exempt from SNUR requirements. The fact that a substance is compounded with a polymer or is contained or encapsulated in a polymer does not necessarily mean that the substance will not become partially or readily released from the polymer, and such releases could be intentional. The Agency believes there could be many instances of significant exposure to substances that have been compounded with or encapsulated in polymers, and thus, such substances should not be generally excluded form IUR reporting. Although EPA appreciates the difficulty in ascertaining quantitative production information from manufacturers outside direct U.S. jurisdiction, exempting IUR reportable components encapsulated in a polymer matrix from IURA is not warranted. Not all polymers arePage 111 of 159 inviolable. Additives such as colorants and lubricants, which can be hazardous to human health or the environment, can leach from the polymer matrix, resulting in subsequent exposures. Also, additives which are inherently insoluble in the polymer may migrate to the surface of the polymeric material and be released over time from the polymer. Under IURA, each non-exempted mixture component is reportable if imported above the stated thresholds.

Comment C.4b-4 : Some commenters stated that low exposure chemicals, such as closed system intermediates, should be exempt from IURA reporting

.

Source: C1-046

Response C.4b-4 : Closed system intermediates are chemical substances which, if transferred from the reaction vessel in which they are created to enclosed storage or to subsequent reaction vessels, such transfer is done by means of enclosed piping and pumping networks. The intermediate is transformed into a different chemical substance in a subsequent reaction at the site where it is created. Closed system intermediate chemicals are exempt from IUR reporting under 40 CFR 710.50(c) only if they are non-isolated intermediates as defined by §710.43 of the revised regulatory text, which states that:

“Non-isolated intermediate” means any intermediate that is not intentionally removed from the equipment in which it is manufactured, including the reaction vessel in which it is manufactured, equipment which is ancillary to the r eaction vessel, and any equipment through which the substance passes during a continuous flow process, but not including
tanks or other vessels in which the substance is stored after its manufacture.”

If a closed system intermediate chemical does not meet this definition, then it is NOT exempt from IUR reporting. The Agency believes that intermediate substances contained in storage tanks or other enclosed equipment or transfer lines could possibly have enough exposure potential to generate some risk concerns.

Comment C.4b-5 : Commenters provided several major comments regarding fossil fuel combustion byproducts. In general, commenters believed these byproducts should not have to report under the IURA. Commenters stated that fossil fuel combustion byproducts should be exempted from IURPage 112 of 159 reporting, even when produced in high volumes, because (1) these chemicals present low hazard or risk when created; (2) byproducts used for certain commercial purposes other than use as fuel, as soil amendments, or as sources of other commerc ial products have previously been exempt (via the inorganics exemption); (3) fossil fuel combustion byproducts have been sufficiently studied for beneficial reuse; and (4) that sufficient data is already provided to the Agency and other federal organizations, such as DOE. Commenters stated that enough review of data had been conducted on these substances, primarily by and for EPA’s Office of Solid Waste (OSW), to allow their use as solid waste in situations where exposures were possible (i.e., with soil amendments or in “recycling” as road building materials). For example, one commenter stated that information on coal combustion byproducts is already available through DOE reporting and the Bevill Amendment Study process under §8002(n) of the Resource Conservation and Recovery Act (RCRA). Commenters argued that reporting on these byproducts under IURA would be duplicative and overly burdensome, especially because these chemicals are considered “beneficially used in an environmentally sound manner” by OSW (Ref. 29). Furthermore, required reporting would serve as a disincentive to beneficially reuse the byproducts. One commenter stated that specific examples demonstrating the need for fossil fuel combustion byproducts information should be given to justify the information collection. In addition, some commenters believe EPA offices like OPPT and OSW must coordinate efforts related to fossil fuel combustion byproducts within each office as well as between offices prior to undertaking any actions under TSCA.

Source: C1-030, C1-035, C1-043

Response C.4b-5: The Agency believes that even if a chemical's uses and hazards have been fully characterized, beyond “basic screening,” EPA needs up-to-date exposure-related information for that chemical. Although a chemical's hazard does not change over time, the amount of human and/or environmental exposure may change greatly over time, thereby necessitating cyclical reporting of such information to the Agency. A change in exposure
information could affect the risk associated with that chemical. A low hazard chemical would also be low risk if exposure potential is low, however the same low hazard chemical may be considered higher risk if exposure potential is high. Chemicals that present low hazard may still pose a risk if they are produced in significant amounts, and / or if they are released into the environment at high volumes and/or concentrations. The Agency allows under IURA exemptions for fossil fuel combustion byproducts thatPage 113 of 159 have no commercial purpose (e.g., are simply residuals or waste streams not further involved in the manufacture or processing of another chemical product) and the inorganic exemption has been removed. EPA has determined that it will not create an exemption from IUR reporting requirements for activities other than those described in 40 CFR 710.50. Under subsection (c) in that section, manufacturers (including importers) of chemicals in the form of byproducts that are used for commercial purposes other than those described as follows are subject to IUR reporting: “If the only commercial purpose of the byproduct is for use by public or private organizations that (1) burn it as a fuel, (2) dispose of it as a waste, including a landfill or for enriching soil, or (3) extract component chemical substances from it for commercial purposes. (This exclusion only applies to the byproduct; it does not apply to the component substances extracted from the byproduct.) (40 CFR 720.30(g)). For example, manufacturers (including importers) of fossil fuel combustion byproducts that are disposed of for commercial purposes as a waste continue to be exempt from IUR reporting with respect to these byproducts. Manufacturers (including importers) of fossil fuel combustion byproducts that are used in making bridges, roadways, etc., however, would not be exempt from IUR reporting. EPA has decided not to create an exemption to cover these latter entities for a number of reasons. Review of the recent OSW regulatory determination on the subject of fossil fuel combustion byproducts, (FR Vol. 65 No. 99, May 22, 2000, 32214-32237), indicates that these products in general can be hazardous to human health and the environment. OSW has decided, however, to exempt fossil fuel combustion byproducts from regulation as hazardous waste when they are “beneficially reused.” ( FR Vol. 65 No. 99, May 22, 2000, pg.32229). While OSW was not able to identify significant risks to human health or the environment associated with beneficial uses of fossil fuel combustion byproducts based on available data, OSW plans to assess new information as it becomes available. The IURA will be instrumental in providing production, use, and exposure data for reportable fossil fuel combustion byproducts, to enable OSW to monitor the potential risk
associated with these chemical substances. Review of such contemporary data, as shared between OPPT and OSW, will allow EPA offices to better coordinate in making well-informed risk management decisions by constructing realistic screening level exposure profiles for these substances. These profiles could be adjusted as the production dynamics changed between reporting cycles. EPA believes the importance of accurate exposure related data in formulating sound risk management decisions for fossil fuel combustion byproducts justifies the associated reporting burden. Further, the acknowledged disincentive to continue beneficial reuse because of the associated reporting requirement could be largely offset by the incentives of commercial gainPage 114 of 159 from expanding such beneficial reuse, and potential uses of such activities in community relations

programs.

Comment C.4b-6 : Some commenters stated that fertilizers should be either partially or fully exempted from reporting under the IURA because they already are well-characterized and generally “safe.” According to the commenters, ample recent hazard and exposure data from studies conducted by EPA’s Office of Solid Waste (OSW) indicate that fertilizers generally are of low toxicity, and some constituents of major fertilizer types are “safe” because the exposure potentials are low. Further, recent SIDS program studies on urea, a common fert ilizer, described the chemical to be “of low priority” as regards further investigation, thereby implying to the commenters both that the chemical poses little hazard to human health and the environment, and that adequate risk information is available. One commenter suggested that the following substances, listed by CAS number, be included in the fertilizer exemption list: 7664-417 (anhydrous ammonia); 1336-21-6 (aqua ammonia); 6484-52-2 (ammonium nitrate); 7783-20-2 (ammonium sulfate); 7783-18-8 (ammonium thiosulfate); 12593-60-1 (ammonium phosphate sulfate); 7783-28-0 (diammoniurn phosphate); 7722-76-1 (monoammonium phosphate); 7631-99- 4 (sodium nitrate); 7757-79- 1 (potassium nitrate); 7757-79-1/763 1 99-4 (potassium sodium nitrate); 8011-76-5 (single superphosphate); 65996-95-4 (granular triple superphosphate); 7447- 40-7 (potassium chloride-), 14168-73-1 (potassium magnesium sulfate); 7778-80-5 (potassium sulfate); 7778-18-9 (calcium sulfate); 7664-38-2 (phosphoric acid); 7697-37-2 (nitric acid); and 7664-93-9 (sulfuric acid).

Source: C1-015, C1-035, C1-040

Response C.4b-6 : Inorganic fertilizers compose a class of chemical substances that have been exempt from the IUR in the past, while organic chemicals used as fertilizers have generally been subject to IUR reporting. EPA does not believe the suggested IURA exemptions for fertilizers and fertilizer materials are warranted at this time. Exposure to these chemicals, especially to children, can be significant. (Children are likely to be exposed to these chemicals on raw foods, or during play.) Therefore the Agency feels that requiring commercial/consumer use information under the IUR amendments for fertilizers containing these chemicals is necessary. In general, the Agency finds that even if a chemical's uses and hazards have been fully characterized, EPA needs up-to-date exposure-related information for that chemical. Although a chemical's toxicity does not change over time, the amount of human and/or environmental exposure mayPage 115 of 159 change greatly over time. A change in exposure information could affect the risk associated with that chemical. A low hazard chemical would typically be considered to be low risk if exposure potential is low; however, the same low hazard chemical may be considered high risk if exposure potential is high. For example, chemicals that present low hazard may st ill pose a risk if they are produced in significant amounts, and/or if they are released into the environment at high volumes
and/or concentrations. The Agency does not agree with industry comments citing a 1999 EPA OSW risk evaluation on “non-nutritive” elements in fertilizers as adequate justification for classifying these substances as “safe,” and therefore eligible for exemption. The cited report addresses trace quantities of metal contaminants in those fertilizers (i.e., the non-nutritive elements), not the fertilizers themselves. A review of basic hazard identification guides, such as the Merck Index, the Condensed Chemical Dictionary, and Dangerous Properties of Industrial Materials, shows that many fertilizers and fertilizer materials including those cited in industry comments, such as anhydrous ammonia, potassium sulfate, and urea, can cause both reversible and irreversible adverse health effects due to exposures ranging from acute to chronic. The Agency therefore believes it appropriate to require information for these chemicals under the IUR amendments. Even if a chemical’s hazards have been fully characterized, EPA needs up-to-date exposure information to adequately screen chemicals for possible risks to human health and the environment. Although toxicity of a chemical generally is fixed (even though, for example, one ionic form of a chemical can be more hazardous than another), a chemical’s exposure profile can vary greatly over time. Human and/or environmental exposures to the substance can at one time be minor, but at another time be a major concern. Therefore, chemicals that present low hazard may still pose a risk if they are produced in significant amounts, or if they are released into the environment at high volumes and/or concentrations. Updated exposure information would improve risk evaluations of those chemicals. The SIDS dossier for urea, a common fertilizer, supports the conclusion that urea is “...of low priority...” in the context of the SIDS program. However, the conclusions expressed in the dossier are based on information inadequate for EPA purposes. Because the SIDS program is designed to promote international cooperation in managing chemicals of concern to all member nations, SIDS emphasizes on hazard assessments over exposure reviews to categorize those chemicals. In the context of SIDS, therefore, urea is low priority because its hazards are well known and are of modest concern. In contrast, the IURA is designed to obtain the latest exposure data, which can change over time and must be timely to be most useful. The SIDS program is suspending the collection of detailed exposure information, because member countriesPage 116 of 159 discovered that exposure situations from one country to the next were too variable to allow useful exchange of the data. Therefore, any exposure information collected by a sponsor country typically is not comparable to that required under the IURA. For example, the Urea SIDS Dossier was developed by Finland, and only provides U.S. production and use data on a national scale, which would be unlikely to provide the specific use and exposure data needed for a U.S.-
based risk assessment.

Comment C.4b-7 : The Agency should exempt pesticides from reporting under the IUR’s TSCA authority, and should exempt those substances outside its purview, including drugs and
cosmetics.

Source: C1-003, C1-015, C1-031, C1-043, C1-059

Response C.4b-7 : The original IUR did not include non-TSCA chemicals as reportable. Similarly, in the IURA, amounts of an otherwise IUR-reportable substance that are intended at the time of manufacture or import to be used for non-TSCA purposes (e.g. as a pesticide, as a drug) do not have to be reported. For example, if a company were to manufacture 100,000 lbs of an IUR-reportable substance, 70,000 lbs of which were intended at the time of manufacture to be sold as a food additive, and 30,000 lbs of which were intended at the time of manufacture to be used for a TSCA purpose, only 30,000 lbs of the substance would have to be reported under IUR. Further, many substances, such as the pesticide “active ingredient” pentachlorophenol or the class of pesticidal “other ingredients” (formerly called pesticide inerts), are also used in industrial/commercial applications regulated under TSCA. In those cases, the chemicals would be reportable under the IURA.

5. Thresholds

Comment C.5-1 : Commenters agreed with raising the general reporting threshold from 10,000 to 25,000 pounds. A commenter stated that this increased threshold is sufficient to capture major production sites. One commenter stated that they agreed with making the threshold consistent with the Toxic Release Inventory’s (TRI) threshold and that they recognize that a lower threshold may be appropriate for the limited number of chemicals that are persistent, bioaccumulative, and toxic. Commenters stated that the Agency should recognize that future reductions in this reporting threshold would again increase the IURA reporting burden.Page 117 of 159 Source: C1-003, C1-010, C1-013, C1-014, C1-022, C1-027, C1-029, C1-031, C1-032, C1-033, C1-037, C1-041, C1-046, C1-047, C1-069, C1-073

Response C.5-1 : EPA increased the general reporting threshold in order to reduce the number of reports filed, thus reducing industry burden. The new reporting threshold does not represent a finding of low exposure or low risk. The Agency does recognize that reducing the reporting threshold in the future could increase the IURA reporting burden, but may change that reporting threshold as the Agency’s needs change.

Comment C.5-2 : One commenter disagreed with raising the general reporting threshold and requested that it be maintained at 10,000 pounds. This commenter stated that the new 25,000 lbs. threshold could eliminate some reports they would find useful. Also, the 10, 000 lbs. threshold could provide valuable information regarding trends in the use of chemicals and the introduction of new chemicals that may replace other chemicals.

Source: C1-064

Response C.5-2 : EPA agrees that useful information may be eliminated due to the increased threshold. The Agency raised the reporting threshold in order to mitigate the increased burden that will result from this rule. While some useful data will be forgone, the more detailed information that will be collected will improve EPA’s and others’ ability to assess and reduce potential chemical risks. EPA may lower the threshold if such information becomes necessary in
the future.

Comment C.5-3 : One commenter requested that the Agency raise the general reporting threshold to 100,000 pounds. The commenter felt that some real savings could be generated in reducing the number of TSCA IUR reports prepared and that EPA would still collect sufficient data on the chemicals widely used by industry in order to update the TSCA inventory.

Source: C1-011

Response C.5-3 : EPA disagrees that a general reporting threshold of 100,000 pounds would provide sufficient information to meet the Agency’s and others’ needs and Congress’ intent. EPA has been charged with identifying and controlling toxic chemical risks to humanPage 118 of 159 health and the environment. Raising the general reporting threshold from 25,000 lbs. to 100,000 lbs. would mean that EPA would receive approximately 10,400 fewer reports on 2,600 fewer chemicals produced in volumes of 25,000 to 100,000 pounds at the site level. These chemicals and reports represent a substantial portion of chemical use and production in the United States. By forgoing even the basic information required of partial reporting, EPA would be completely incapable of assessing the potential risks posed by this large portion of the chemical industry and would be unable to update the TSCA Inventory, as required under TSCA.

Comment C.5-4 : Commenters agreed with adding a second reporting threshold of 300,000 pounds for reporting processing and use information.

Source: C1-003, C1-013, C1-022

Response C.5-4 : While EPA finalized the 300,000 lbs. threshold for processing and use information, the Agency also recognizes that similar exposure information on lower volume chemicals may be needed. Because of this, EPA may change this threshold in a future amendment, or may collect the information in another manner.

Comment C.5-5 : Some commenters disagreed with EPA’s establishment of a 300,000 lbs. threshold for reporting processing and use information rather than the 100,000 lbs. threshold that the Agency also considered. Commenters believed EPA’s rationale of reducing paperwork burdens on submitters is insufficient. They argue that establishing a 100,000 lbs. threshold will gather useful information on processing, use, and worker exposure for lower production volume chemicals. By setting the bar too high, EPA will be ignoring a crucial set of data for risk screening and priority setting on an important segment of chemical users and exposed workers.

Source: C1-051, C1-064, C1-065

Response C.5-5 : EPA agrees that raising the threshold to 300,000 lbs. does omit useful information on chemicals produced below that threshold. As noted by EPA on page 46786 of the preamble for the proposed rule, “... informati on concerning lower production volume chemical substances is valuable, especially for iden tifying trends and additional substitute ch emicals...” The 300,000 lbs. threshold was agreed upon during interagency review as a way to limit burden while still collecting data on almost all of the high production volume (HPV) chemicals.Page 119 of 159 Additionally, EPA believes the 300,000 lbs. threshold strikes an appropriate balance between the Agency’s current information needs and the burden imposed by IURA.

Comment C.5-6 : Several commenters suggested alternative threshold levels for submitting processing and use information. A commenter suggested a level of 500,000 pounds to further reduce the reporting burden. Another commenter stated that EPA should set the threshold for reporting processing and use information at 1 million pounds or more per year on a company (versus a site) basis, given that EPA stated in the proposed rule (pg. 46785) that EPA’s initial focus would be on processing and use information associated with large volume chemical substances. The commenter claimed that chemicals manufactured at greater than a million pounds a year per company qualify as larger volume chemicals and should be higher on EPA's priority list than chemicals produced at smaller volumes. The Agency would be able to focus its limited resources first on the higher volume chemicals while it develops the means and methods necessary to assess the submitted information in a meaningful and timely manner. Another commenter stated that EPA should use the 1,000,000 (lb/yr) national aggregate production volume threshold as already established in the related voluntary HPV Challenge Program. Having the same threshold criteria would enable all parties to focus their efforts on the development of enhanced exposure and effects/property data for a single, consistent set of substances. This would reduce the potential for confusion in users of the data and significantly reduce unnecessary burdens to chemical manufacturers and importers.

Source: C1-013, C1-046, C1-047, C1-068

Response C.5-6 : EPA considered a range of reporting thresholds for submitting processing and use information and selected the threshold of 300,000 lbs. While higher thresholds do reduce the burden, they also reduce the information submitted through IURA - information that has already been reduced by the selected 300,000 lbs. threshold.

EPA disagrees with setting the reporting threshold for processing and use information at either a company-wide or a national production level. See the response to comments B.2-1 and B.2-3 for further discussion of these alternate reporting designs. EPA determined chemicals eligible for the HPV Challenge Program based on aggregate, nationwide production volumes of one million pounds or more, based on 1990 IUR production volume data. If one million pounds of a certain chemical are manufactured collectively, in a givenPage 120 of 159 year, by all manufacturers (including importers) throughout the United States, then that chemical is defined as an HPV chemical. EPA chose the 300,000 pound threshold for two reasons: 1) to decrease the burden associated with reporting (as compared to the 100,000 pound threshold) and, 2) to ensure that information is collected on virtually all HPV chemicals. The 300,000 pound threshold captures a least one report for more than 95% of the HPV chemicals reported to the 1990 IUR, the collection used to determine the initial pool of HPV Challenge program candidates. The production volume that defines chemicals as HPV should not be confused with the reporting threshold for processing and use data reporting in the amended IUR. The 300,000 pound IURA threshold is for the amount produced at a single site and is not an aggregate, industry wide production number. The 300,000 pounds per year reporting threshold limits the chemicals reporting downstream exposure-related data to approximately 4000 (consistent with the several thousand chemicals suggested by GAO in it's 1995 report ``EPA Should Focus Its Chemical UseInventory on Suspected Harmful Substances,'' GAO/RCED-95-165), and ensures that exposurerelated data will be reported for almost all HPV chemicals (defined by national aggregate production). Increasing the per site 300,000 pound threshold to either 500,000 or 1,000,000 pounds would drastically undermine the Agency’s reasons for collecting the processing and use exposure-related data by reducing the number of chemicals for which information is submitted and by eliminating reporting on many of the HPV chemicals. The Agency would not be able to effectively use this information for screening level assessments as intended.

Comment C.5-7 : One commenter claims the effort required to track production volume for each reportable chemical for any single company site is very burdensome, and of limited benefit. “Performing this work to prove that a chemical is not subject to reporting, seems redundant and outside the spirit of the EPA's intention to reduce burden. Some enforcement leeway should be granted to those companies that can justify a non-report on the basis of "theoretical" volumes less than 25,000 pounds per year. Where companies have not developed computer systems to fully collect the final volume of chemicals, theoretical calculations based on previous use, future use, or another reasonabledetermination of use should be acceptable. For larger companies, this justification can potentially save hundreds of hours of tracking.” Other commenters supported e liminating the requirement to keep volume records for substances that fall below the reporting threshold.

Source: C1-010, C1-027, C1-028, C1-041Page 121 of 159 Response C.5-7 : The Agency has removed the requirement that firms not submitting IUR reports retain production volume records in support of that decision. However, the Agency believes that the information needed to determine whether reporting is required is part of normal business records. EPA recognizes that special circumstances may exist, and therefore production volume records that are unavailable may not meet the “reasonably ascertainable” standard. EPA expects such instances to be extremely rare.

D. Definitions and Clarification Requests

1. Inorganic Chemical Substance

Comment D.1-1 : One commenter noted that the definition of “inorganic chemical substance” in the proposed regulatory text section 710.26(a) is faulty. It seems to say that carbon, graphite, diamond, carbon dioxide, carbon monoxide, the various carbides and other materials that a chemist would define as inorganic are actually organic. The commenter understood that this definition would be deleted by the proposed changes and suggested that EPA be careful in defining organic versus inorganic chemical substances.

Source: C1-001

Response D.1-1 : The Agency is not deleting the definition of inorganic chemical substances. Under IURA, inorganic substances would be initially subject only to partial reporting, whereas organic substances, unless specifically excluded from reporting under section 710.46 of the final regulatory text, would be subject to full IUR reporting. Therefore, this definition of inorganic chemical substance will be needed to determine whether or not a substance would be subject to partial or full IUR reporting. The IURA does not change the definition of inorganic chemical substances. For IURA reporting purposes, inorganic chemical substances will continue to be defined as any chemical substance that does not contain a carbon atom, or contains carbon only in the form of carbonato [=CO3], cyano [-CN], isocyano [-NC], cyanato [-OCN], or isocyanato [-NCO], groups, or the chalcogen analogues of these groups [40 CFR 710.26(a)]. Although chemists may differ on their classification, the Agency has also chosen to also exempt carbon black [CASRN 1333-86-4], carbon [CASRN 7440-44-0], graphite [CASRN: 7782-42-5], and charcoal [CASRN: 16291-96- 6] from the reporting requirements for organic chemicals under the IUR; they will, nevertheless,Page 122 of 159 be subject to the reporting requirements for inorganic chemical substances. Carbides are considered to be organic chemical substances.

Comment D.1-2 : One commenter asked that EPA clarify that process and use information is required only for organic chemicals by adding word ‘organic’ to the Part III Form U requirements.

Source: C1-056

Response D.1-2 : For the first reporting period following promulgation of the IURA, EPA is requiring only partial reporting for inorganicsubstances (i.e., inorganic chemical substances would not be subject to the reporting of processing and use information). EPA is requiring full reporting for organicsubstances, based upon production volume, for the first reporting period following promulgation of the IURA. For subsequent reporting periods, manufacturers (including importers) of inorganic and organic substances will both be subject to the processing and use information reporting requirements, to the extent that they manufacture (including import) at least 300,000 lbs. of a substance. EPA has clarified this in the preamble for the final IURA and in the
instruction manual.

2. Chemical Industry

Comment D.2-1 : One commenter stated that the Agency focused on the “chemical manufacturing industry” “without specific consideration of its data needs regarding the ancillary production of byproduct materials from other industry sectors that would be swept into IUR reporting as the result of its broad definition of manufacture in 40 CFR § 710.2" of the proposed regulatory text.

Source: C1-043

Response D.2-1 : EPA listed a fairly comprehensive list of affected industries in the economic analysis, but used the term “chemical industry” in other discussions. EPA's intention was to use the term “chemical industry” to represent all of the industries reporting under this rule. EPA fully intends for any company meeting the reporting requirements of the rule to be represented by the term “chemical industry,” regardless of whether the company fits under thePage 123 of 159 NAICS definition of the term “chemical industry” or under a different industry. Under 40 CFR 710.50(c), manufacturers (including importers) of chemicals in the form of byproducts which are used for commercial purposes are subject to IUR reporting unless the only commercial purpose of the byproduct is for use by public or private organizations that (1) burn it as a fuel, (2) dispose of it as a waste, including in a landfill or for enriching soil, or (3) extract component chemical substances from it for commercial purposes. (This exclusion only applies to the byproduct; it does not apply to the component substances extracted from the byproduct.) (40 CFR 720.50(g))

3. Site

Comment D.3-1 : One commenter was confused about the definition of a “site.” The commenter asked how the report should be completed if the submitter has multiple sites, with some sites manufacturing more than 300,000 lbs., and other sites, less.

Source: C1-056

Response D.3-1 : If a submitter is reporting for multiple sites, a separate submission needs to be completed for each site. The processing and use information reported on Part III of revised Form U must be completed for each reportable chemical at each individual site that manufactures or imports more than 300,000 pounds of the reportable chemical. Part III does not need to be completed for individual sites that manufacture or import less than 300,000 pounds of the reportable chemical. The reporting requirements for individual sites have been clarified in the preamble for the final IURA and in the instructions manual.

4. Importers

Comment D.4-1 : One commenter felt that import data for processed or formulated substances should be excluded from IUR reporting. The commenter believes it it is very burdensome because “every formulated product (including perfumes) must be broken down into its various components and then tallied for totals to determine if reporting thresholds are met.” This commenter suggested that the Agency make reporting requirements for imported chemical substances similar to requirements for manufactured substances, for which reporting is “required only if given chemicals are used and released at a specific site.”Page 124 of 159 Source: C1-003, C1-028, C1-046, C1-061

Response D.4-1 : Under TSCA section 3(7), importing is equivalent to manufacturing. Congressional intent when developing TSCA was that domestic manufacturers and importers be treated with parity (H.R. Rep. No. 94-1341, 94th Cong., 2d Sess. 12-13). As a result, importers are treated similarly to manufacturers under EPA’s TSCA regulations. These IUR amendments specify that IUR reporting is required of entities that manufacture (i.e. produce or import) 25,000 lbs. or more of an IUR-reportable substance at a site in a year. The requirement that IUR reporting be done by a particular entity, whether a domestic manufacturer or an importer, does not depend on that entity’s use or release of a substance. Although EPA appreciates the difficulty that may sometimes be associated with requesting quantitative production information from foreign manufacturers, U.S. importers are required to seek only whatever information is reasonably ascertainable to estimate import quantities.

Comment D.4-2 : Commenters suggested that if import data could not be excluded completely, all imported mixtures/formulated products should be excluded. A commenter stated that “for companies that import processed materials, it is meaningless to describe manufacturing characteristics of these substances. Many are mixtures of a large number of chemicals. They may be in various physical forms and many concentrations and no worker exposure at the manufacturing site is involved.”

Source: C1-003, C1-028, C1-046, C1-061

Response D.4-2 : Under the TSCA regulations, including the IURA, importers are considered to have manufactured each of the components of imported mixtures. However, importers are only required to complete IURA reports if they import at least 25,000 lbs. of an IURA-reportable substance (whether as a component of a mixture or otherwise) in a year. For instance, if a company is importing 100,000 lbs. of a mixture at a site, the submitter must report, under the IURA, any components accounting for 25% or more of that mixture. Information on physical forms and concentrations of imported mixtures are important for screening potential exposures for downstream sites and users even when there are no exposures at the import site. The multiple physical forms and concentrations issues have been covered in the response to comment B.4c-1.Page 125 of 159 Comment D.4-3 : One commenter asserted that processors should not have to report exposure and use information.

Source: C1-003, C1-028, C1-061

Response D.4-3 : Although EPA has the authority under TSCA section 8(a) to require processors to report under IUR, processors have never been subject to IUR reporting in the past, and will not be subject under these IUR amendments (see 40 CFR 710.48).

Comment D.4-4 : One commenter took issue with EPA’s definition of plant site for importers, stating that in the proposed IUR amendments (at 46786 and in the regulatory text), EPA defines the plant site for an importer as “the site of the operating unit within the importer’s organization that is directly responsible for importing the substance and that controls the import transaction, and may in some cases be the organization’s headquarters office in the United States.” The commenter believes that requiring an importer to report its headquarters office as its plant site would result in the reporting of meaningless site-specific information by the importer. In addition, the commenter stated that importers should not be required to comply with the new up-front substantiation requirement for certain confidential business information (CBI). According to the commenter, in many cases importers are product formulators whose formulas are proprietary. For these reasons, the commenter believes that EPA should create exceptions for importers from the requirements it has laid out in the proposed IUR amendments.

Source: C1-073

Response D.4-4 : The provision referred to in this comment has been present in the IUR regulations since 1986, and EPA does not intend to modify it in the current rulemaking. Provisions which identify the site at which the chemical substance is imported are necessary to affix the responsibility to complete and submit the IUR report. In 1985, when the provision was first proposed, EPA had suggested that the importer identify its company headquarters office as the plant site responsible for IUR reporting (50 FR 9944, 9952, March 12, 1985). However, when the provision was finalized in 1986 (51 FR 21438, 21448, June 12, 1986), it reflected the language that is still in place today at 40 CFR 710.48(c). The 1986 final rule stated that for importers subject to IUR reporting, “[IUR] reports would be made by the site which actually conducts the import operation--either the specific plantPage 126 of 159 or the corporate headquarters.” 51 FR 21438, 21440. The Agency also stated that under TSCA “an importer means ‘* * * any person who imports a chemical substance, including a chemical substance as part of a mixture or article, into the customs territory of the United States,’ and includes ‘* * * the person primarily liable for the payment of any duties on the merchandise* * *’. . . . [C]ertain importers must report by the United States headquarters or s imilar central office. However, if a plant site imports a substance directly from a foreign supplier and is ‘primarily liable for the payment of any duties’ on that substance, the plant is then the importer of that substance. In that case, the imported substance must be reported directly by that plant site. This approach allows companies to report consistent with the conduct of their importing.” 51 FR 21438, 21441. EPA has therefore required that certain importers report by company headquarters office while others report by individual plant site. This provision further ensures that IUR information reported by importers is meaningful. The Agency does not agree that importers should be exempt from the new up-front CBI substantiation requirements for plant site identity information. Although EPA understands that importers may at times wish to protect these data as CBI, importers’ concerns in this area match those of manufacturers and do not warrant an exemption from the substantiation requirements. Indeed, under TSCA section 3(7), manufacturers and importers are considered to be equivalent; therefore, EPA treats them similarly under its TSCA regulations, including the IUR.

E. Confidential Business Information

1. General CBI

Comment E.1-1 : Commenters stated that the new data elements raise significant CBI concerns and that the proposed IURA can be expected to result in a significant increase in the
number of CBI claims.

Source: C1-016, C1-032, C1-033, C1-047, C1-067

Response E.1-1 : EPA agrees that CBI claims will likely be made for the new data elements that are being added by the IURA, possibly resulting in a greater number of CBI claims overall. However, the Agency has taken steps to enable the Agency to publicly use IURA information. For instance, EPA is requiring reporting for most of the new data elements in ranges, a reporting method the Agency believes will result in fewer CBI claims compared toPage 127 of 159 reporting discrete numbers. EPA is also amending the IUR to include a new requirement to provide up-front substantiation of CBI claims for plant site identity. The amendments serve to ensure that claims are legitimate by requiring submitters to perform an initial evaluation of the need for and validity of a CBI claim for plant site identity, an essential data element.

Comment E.1-2 : A commenter stated that, because of the expected increase in CBI claims, the Agency will need more resources to handle the incoming data. Therefore, the commenter anticipates that it will take longer for the Agency to make the information available to Agency personnel and stakeholders.

Source: C1-021

Response E.1-2: The number of CBI claims does not affect the speed with which the Agency will be able to process the IURA information and make it available to the public. The Agency expects to have sufficient resources to process the incoming data and the expected increase in the number of electronic submissions will facilitate initial data capture and reconciliation activities. The data collected through the IURA will be transferred directly into a database which provides the ability to quickly segregate confidential and non-confidential
submissions and/or claims.

Comment E.1-3 : Many commenters suggested that EPA is trying to discourage legitimate CBI claims by making their assertion overly burdensome, even though TSCA provides that certain submitted information may be claimed confidential. Included in this issue is the concern that imposing unnecessary additional reporting requirements on businesses that are trying to protect their confidential information from competitors, including those overseas who are not regulated by the EPA and therefore don’t incur the expense of IURA reporting, puts these firms at a competitive disadvantage.

Source: C1-016, C1-047, C1-069

Response E.1-3 : EPA wishes to clarify that it is not attempting to discourage legitimate confidentiality claims. Rather, the Agency intends to encourage only appropriate and necessary claims, so it can continue protecting legitimate CBI while also maximizing the amount ofPage 128 of 159 information available for public use. EPA has information indicating the existence of inappropriate or no longer valid CBI claims. For instance, when EPA selectively challenged CBI claims in the past, many of these claims have been amended by the companies to make the information available to the public. Additionally, OPPT’s Administrative Record 00125, which contains state CBI data reviews, published articles, industry letters, and other papers discussing CBI issues, provides further indication that inappropriate or no longer valid CBI claims exist. For instance, the Georgia Department of Natural Resources reported in a 1996 CBI Data Review that IUR data identified as confidential were available in other non-confidential databases (Ref. 30). The Administrative Record is in the same location as the Docket, and is available by following the procedures identified in Unit II.B.2. of the preamble for the final rule. EPA disagrees with the assertion that the IURA requirements make the assertion of legitimate claims overly burdensome. EPA estimates that, every four years, submitters of CBI plant site identification information will incur a burden of only 0.9 to 2.0 hours. Burden estimates developed in the Economic Analysis for the final rule are discussed in the Up-Front Substantiation and Reassertion sections of this portion of the response to comments document, the Economic section of this document (see Sections E.2, E.3, and G.1 of this document, respectively). Commenters should keep in mind that IUR reporting occurs once every four years, not annually, and that information protected at taxpayer expense qualifies for that protection by meeting the minimum legal criteria. EPA believes that firms that comply with IURA reporting not are put at a competitive disadvantage because the burdens imposed by the IURA are not excessive.

a. Protection of CBI

Comment E.1a-1 : Commenters expressed concern about the Agency’s ability to protect CBI from inappropriate release and stated that, under Section 14 of TSCA, EPA has a statutory obligation to protect from improper disclosure information properly claimed CBI. Commenters are concerned about inappropriate past releases of information claimed as CBI, and believe that IURA will “unduly foster the release of sensitive and proprietary CBI.” They would like to see the Agency take steps to guarantee greater protection of CBI data.

Source: C1-004, C1-011, C1-012, C1-016, C1-019, C1-033, C1-069

Response E.1a-1 : EPA is continually exploring ways to better protect information claimed as confidential, including soliciting input from regulated parties. During the past severalPage 129 of 159 years the Agency has committed significant resources to strengthening its CBI management procedures. For example, the Agency is revising and updating its TSCA security manual. The Agency has no reason to believe that IURA will lead to an increase in improper releases of CBI. To the contrary, in recent years administrative incidents have been dramatically reduced, and the Agency is continuing its efforts to protect against improper disclosure.

Comment E.1a-2: A commenter is concerned that the Agency is compromising the safety of CBI by allowing Federal contractors to have access to the information. This commenter also expressed concern about the continued protection of CBI information when a Federal employee leaves and takes a position in the private sector.

Source: C1-019

Response E.1a-2: EPA’s CBI protection procedures extend to Federal contractors, exemployees, and certain others who may legitimately need access to the data. TSCA Section 14(a)(2) provides that CBI shall be disclosed to contractors and their employees if EPA determines the disclosure is necessary for the satisfactory performance of a federal contract under the Act. One of the measures EPA employs in carrying out this statutory provision requires that all contractor employees sign a Confidentiality Agreement upon relinquishing TSCA CBI access authority. In the agreement, contractor employees affirm the following:
“

I agree that I will not remove any copies of materials containing TSCA CBI from the premises of my company or from EPA premises upon my relinquishment of TSCA CBI access authority. I further agree that I will not disclose any TSCA CBI to any person after my relinquishment of TSCA CBI access authority

.

“

I agree that as a contractor employee who has been authorized access to TSCA CBI, under Section 14(d) of TSCA (15 USC 2613(d)) I am liable for a possible fine of up to $5,000 and/or imprisonment for up to one year if I willfully disclose TSCA CBI to any

person. ” EPA requires federal employees who terminate their employment or otherwise relinquish TSCA CBI access authority to sign an agreement containing substantially s imilar language.

b. Disclosing customer confidential informationPage 130 of 159 Comment E.1b-1 : Several commenters expressed concern that their customers would be unwilling to provide them with confidential processing and use data. A natural gas commenter expressed concern that, as a producer of chemical feedstocks, it might inadvertently report customer data and not claim the information as CBI, while its customer reports the same data to
EPA under IURA and does claim it CBI.

Source: C1-028, C1-031, C1-033, C1-047, C1-048, C1-055

Response E.1b-1 : EPA does not believe that reporting customer data will be a significant issue. The downstream processing and use information that some submitters will be required to provide under the IURA is not tied to customer identities or to the identities of their products. Submitters will not report who their customers are, where they are located, or what or how much they produce individually. The readily obtainable reporting standard for processing and use information does not require a submitter to poll customers for information, therefore the submitter need not ask for or gather CBI from customers. In addition, CBI claims can be made as necessary for any information provided on Form U. Manufacturers of the natural gas substances described in section 710.46(a)(4) of the regulatory text are generally fully exempt from reporting under the IURA, so this commenter will not be subject to any reporting requirements concerning customer
data.

c. Production volume ranges

Comment E.1c-1 : Commenters had mixed reactions to the use of predetermined production volume ranges as a means of making more production volume information available to the public. Some commenters believe this approach will be su ccessful, while others stated that the ranges were too narrowly drawn. Commenters stated that their CBI claims would likely increase because the production volume information can be combined with new exposure data to reveal confidential information, and because the data would allow competitors to predict process and actual production volume data at a particular site.

Source: C1-009, C1-023, C1-033, C1-041, C1-045, C1-047, C1-061, C1-073

Response E.1c-1 : EPA agrees that the wider the reporting ranges, the fewer the CBI claims. However, EPA has set the reporting ranges to provide the information necessary to meetPage 131 of 159 Agency and the public’s needs for screening level data. Moreover, despite these comments, the Agency has determined that it is worthwhile to require submitters to consider whether their production volumes, within the original Inventory ranges, warrant protection as CBI. Some submitters will make CBI claims for both the specific and the ranged production volume information. However, EPA believes that in many cases submitters will allow the release of ranged production volume information without fear that the data will be misused by competitors. For example, in a 1993 letter, a company suggested the use of the original Inventory production volume ranges for non-confidential reporting. While this company did state that a submitter conceivably could be able to justify a CBI claim for a range, the conclusion was that many companies would be satisfied with reporting in these ranges non-confidentially (Ref. 31). These conclusions are further supported by EPA’s experience with the original Inventory, where only 35% of production volume values reported to the original TSCA Inventory were claimed CBI, compared to the typical claim level of 65% for production volumes under the IUR.

2. Up-Front Substantiation

Comment E.2-1 : Commenters stated that the proposed up-front substantiation requirement for plant site identity information is not authorized under TSCA. Other commenters feel that requiring up-front substantiation for each piece of data is overly burdensome and an arbitrary exercise of authority. The commenters state that instead of up-front substantiation, substantiation should be required only if a request for public disclosure is made.

Source: C1-009, C1-016, C1-026, C1-033, C1-038, C1-047, C1-060, C1-055, C1-069

Response E.2-1 : Up-front substantiation is authorized under TSCA Section 14(c): “a [confidential] designation under this paragraph shall be made in writing and in such manner as the Administrator may prescribe.” Up-front substantiation is one element of CBI designation. EPA emphasizes that it is not requiring up-front substantiation for each data element. The Agency has been and is continuing to require up-front substantiation of chemical identity CBI claims, and is now requiring that submitters also provide up-front substantiation of CBI claims for plant site identity. No other data elements will require up-front substantiation for CBI claims made under
IURA. The Agency is adding the up-front substantiation requirement for plant site identity because EPA has observed that, on occasion, this information has been claimed as confidentialPage 132 of 159 even though, for example, it was revealed (without CBI claims) in TRI public filings, under sections 311, 312 and 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA), 42 U.S.C. sections 11001 to 11050. Such CBI claims are inappropriate and the new up-front substantiation requirement will reduce the occurrence of such claims. Fewer inappropriate claims will allow EPA to make more plant site information available to other Federal agencies and the public. Up-front substantiation of CBI claims imposes some additional burden, although this burden is not substantial. EPA’s economic analysis for this rule provides an estimate of 0.9 to 2.0 hours for the incremental costs of providing up-front CBI substantiation for plant site identity under IURA. (See the Economic Analysis for more details). Substantiation of all CBI claims will continue to be required when a challenge to the claim is made pursuant to a request for public disclosure, as is current practice.

Comment E.2-2 : Several commenters feel that requiring up-front substantiation is unnecessarily burdensome. One commenter suggests simplifying the currently detail-oriented 11 question report with only two questions: (1) Are the specified data confidential? and (2) In as great as detail as possible, explain why this information should be given CBI protection. Another commenter stated that up-front substantiation should be limited to a certification that the CBI data are not otherwise available and that the submitter undertakes efforts to protect the data from disclosure. This commenter feels that EPA should pursue actions against individual submitters who make spurious CBI claims, rather than impose across-the-board obstacles and costs to the assertion of legitimate claims.

Source: C1-016, C1-047

Response E.2-2 : EPA believes that requiring responses to the list of substantiation questions in section 710.58 of the regulatory text is necessary to ensure that certain information submitted for confidential protection qualifies for that protection. The commenters’ proposed questions, while providing the opportunity for a submitter to express its business reasons and preferences regarding the information, do not provide all of the necessary information to definitively evaluate the eligibility of the information for confidential treatment. While EPA intends to take action against individual spurious claims, the Agency can best determine whether a CBI claim of chemical or plant site identification is valid through affirmative substantiation provided by submitters.Page 133 of 159 3. Reassertion

Comment E.3-1 : Commenters were generally negative about the proposed requirement that they reassert their previous IURA CBI claims. Commenters stated that the reassertion requirements would be overly burdensome, unnecessary, and even punitive. Some commenters felt that the requirements would weaken protection of legitimate CBI by inducing some submitters feeling overburdened by the requirements to forego reassertion and their rights to CBI protection.

Source: C1-003, C1-009, C1-010, C1-011, C1-012, C1-016, C1-018, C1-019, C1-032, C1-033, C1-038, C1-041, C1-047, C1-055, C1-060, C1-069, C1-073

Response E.3-1 : EPA did not propose to require resubstantiation, but rather reassertion of CBI. A number of commenters appeared to use the terms “reassertion” and “resubstantiation” interchangeably. However, EPA did not promulgate the reassertion portion of the proposal, and therefore there are no current requirements to reassert previous CBI claims. The decision to not promulgate reassertion requirements was made during interagency review, in order to reduce the
burden associated with these amendments. Submitters must remember that information submitted to the Agency only qualifies for confidential treatment when it meets the regulatory criteria established under 40 CFR Part 2. Because the need for CBI protections for a given piece of information often changes over time, EPA believes submitters must periodically review the circumstances surrounding their information and determine if their claims continue to qualify. EPA does not view this process as either unreasonable or unnecessary, and certainly not punitive. Without a reassertion requirement, EPA protects indefinitely, and at taxpayer expense, information claimed as CBI which may no longer qualify for such protection. EPA believes that the benefits of maintaining only claims for CBI which have legal, contemporaneous merit, and clearing all other information for public release outweigh the comparatively minor burden of completing the simple reassertion requirement. If a submitter’s information truly qualifies under the regulatory standards and CBI protection remains necessary, then it is logical to assume a submitter will take whatever required action necessary to protect its business interests rather than forego protection. EPA takes seriously its responsibility under TSCA to protect CBI. However, information is CBI only if submitters can verify this fact. EPA views this responsibility on the part of the regulated community to be ongoing.Page 134 of 159 Comment E.3-2 : A number of commenters objected to “yearly reassertion” requirements for previous CBI claims.

Source: C1-019, C1-028, C1-032

Response E.3-2: The commenters are incorrect in their characterization of the reassertion requirement as a yearly effort. In fact, IURA data are collected, and previous CBI claims would have needed to be reasserted, only once every four years, not on an annual basis as the

commenters state.

Comment E.3-3: Commenters also stated that EPA does not have the authority under TSCA to require reassertion.

Source: C1-010, C1-011, C1-018, C1-032, C1-033, C1-038, C1-055, C1-060

Response E.3-3 : Section 14(c) of TSCA invests the Agency with the authority to prescribe the manner in which CBI shall be designated. In proposing these amendments, EPA considered initiating a quadrennial reassertion requirement as part of this designation process.

Comment E.3-4: Numerous commenters objected strongly to the proposed requirement that submitters affirmatively reassert their CBI claims, and that failure to do so will result in automatic declassification of the data. Several submitters stated that if a chemical is not reported in a given submission period because it was not manufactured or imported during that reporting year, submitters should not have to reassert previous CBI claims. The submitters felt that all existing CBI claims should automatically remain in effect without the submitter needing to take any action. Other commenters stated that EPA would violate the law by releasing, without prior written notice to the submitter, CBI which had not been reasserted. Even if a submitter fails to reassert a CBI claim, commenters contend that the information continues to be “designated” CBI and protected from release unless EPA provides prior notification of intent to disclose it. One commenter recommended that at a minimum, if a submitter does not reassert a claim, the Agency should first contact the submitter and give it the opportunity to supply supporting documentation for its claim before the claim is deemed to be automatically dropped and information publicly
released.Page 135 of 159 Commenters also recommended that CBI be declassified only upon the affirmative and voluntary act of a submitter, such as indicating on the Form U that it wishes to withdraw a claim, and not by default for failing to reassert.

Source: C1-003, C1-011, C1-024, C1-028, C1-029, C1-032, C1-033, C1-041, C1-047, C1-048, C1-055, C1-060, C1-069

Response E.3-4 : The Agency agrees that EPA is required to provide notification of intent to disclose confidential information. Under TSCA, 15 USC Section 2613(c), “ ...if the Administrator proposes to release for inspection data which has been designated under paragraph (1)(A), the Administrator shall notify, in writing and by certified mail, the manufacturer, processor, or distributor in co mmerce who submitted such data of the intent to
release such data. ” The IUR amendments were to include a periodic reassertion requirement as a necessary component of designating IUR information as confidential. A designation of CBI under IURA would have been effective until the subsequent reporting period, after which, if not re-designated (i.e., reasserted), the claim would have been considered abandoned or withdrawn, and it would have ceased to be a valid, designated claim justifying continued CBI protection. While EPA did not promulgate this requirement, it believes this requirement is justified because the Agency cannot know whether any given piece of formerly submitted CBI still qualifies as CBI under the substantive criteria found at 40 CFR 2.208, as judged to be met by reviewing a claimant’s answers to the questions found at 710.58 of the regulatory text. TSCA does not require EPA to protect in perpetuity information that was once legitimately claimed as CBI, but no longer warrants CBI protection. Requiring a submitter to reassert its claim(s) every four years--including reviewing and re-evaluating claims made on prior reports--is consistent with this legal responsibility. Furthermore, submitters are free at any time to notify EPA that they wish to withdraw a CBI claim. However, EPA believes that a higher number of previous CBI claims which no longer meet the criteria will be withdrawn under an affirmative reassertion program than under a voluntary withdraw plan and, while the Agency is not promulgating the reassertion requirement at this time, EPA may add a similar requirement in the future.

Comment E.3-5: Commenters expressed concern that the proposed reassertion requirement would create a “multiplier effect” that would require submitters to review all prior data items claimed confidential starting in 2006. In the case where a data element has lost itsPage 136 of 159 confidential status, the submitter would be required to prepare a revised report to reflect the change in status of some of the data. According to one commenter, this would create increased burdens in subsequent years, which EPA did not consider in its analysis. A related issue was raised by another commenter, who was concerned that the five-year record retention requirement would lead to situations where a submitter who needed to resubstantiate an answer (in 2010, for example) made in a claim more than five years prior (ie., in 2002), would no longer have the necessary records to support the resubstantiation.

Source: C1-021, C1-028, C1-033, C1-055, C1-061

Response E.3-5: EPA disagrees with the commenters that reassertion will have a multiplying effect on burden. The nature of the requirement is that submitters review their previous CBI claims to make sure they are still valid in the current submission period. If previous claims are no longer valid or CBI protection is no longer needed, the submitter informs the Agency in the reassertion section of Form U in the current submission period. The submitter should need to go back only to the previous report to review the claim and be able to reassert it, if desired, in the current submission period. If the submitter does this every reporting cycle, then each report w ill be based on updated information and the submitter won’t have to go back more than one reporting cycle to verify the ongoing validity of the CBI claim. EPA is assuming that the initial claim was valid. Therefore, the reassertion process should entail only a check on the previous report’s reassertion that the information initially claimed as CBI still meets the legal requirements for protection, e.g., that the information was not made public during the prior four

years. The same holds with the five year record retention requirement. Each submission period’s report should be based on updated and reverified information. If either a portion of an answer or an entire answer to a substantiation question has changed from its original answer, the submitter should have only to go back one submission period to update the answer.

Comment E.3-6 : By proposing the IURA, EPA is stating that the value of CBI automatically diminishes over time.

Source: C1-016, C1-033, C1-073

Response E.3-6 : EPA does not assume that CBI diminishes over time, nor is any lessPage 137 of 159 valuable to submitters after it has been initially reported. EPA recognizes that information that at one time may have qualified under the legal requirements as CBI may no longer qualify, or the circumstances that caused the information to be claimed as CBI, may change over time. Through reassertion, EPA was proposing that submitters simply reaffirm that the CBI designation is still needed and is still legally justified. This proposed requirement was in the interest of maintaining the integrity and accuracy of the CBI files on which EPA expends considerable taxpayer

resources.

F. Administrative Comments

1. Frequency of Reporting

Comment F.1-1 : Several commenters stated that they believe one-time reporting of the new IURA information would be more appropriate than recurring reporting for the intended purposes expressed by EPA. In general, commenters stated that EPA could use tools such as PAIR to identify changes in a particular chemical’s exposure or use profile at the time the Agency decides to do a risk analysis. A few commenters stated that there is insufficient change in the chemical industry to warrant additional reporting, especially for higher volume chemicals. Severalcommenters questioned why one-time data collection efforts would not provide useful exposurerelated data, particularly if they are focused on a subset of high priority chemicals.

Source: C1-009, C1-010, C1-011, C1-016, C1-018, C1-024, C1-027, C1-028, C1-033

Response F.1-1 : EPA’s experience with past IUR reporting demonstrates that the chemical industry is indeed dynamic, with a 30% change in chemicals reporting from one submission period to the next. The specific chemicals that are reported or not reported in any single submission period change at a variety of production volumes; this change is by no means limited to lower production volume chemicals. EPA did consider one time reporting for the processing and use data that will be collected under these amendments, as well as reporting processing and use data every other reporting cycle (once every 8 years) while still collecting basic IUR data (i.e., the data reported on partial forms) every 4 years. However, the one time reporting would quickly become out of date. Reporting some of the data every 8 years and the remaining data every 4 years would keep the processing and use data somewhat updated, but would be difficult and confusing to administer, both for the submitter and for the Agency.Page 138 of 159 EPA’s reasons for collecting the basic IURA data include providing a database of information which can be used for screening level purposes and to identify chemicals for further assessment. EPA intends to use other data sources and collection tools, as appropriate, once a
chemical has been identified as a candidate for further assessment.

2. Calendar year reporting

Comment F.2-1 : One commenter felt that the requirement to report data on a calendar year basis instead of a company fiscal year basis would increase systems development needs for companies who report their volume manufacturing on a fiscal year basis versus a calendar year basis (by creating the need for a second tracking system) while providing no additional value or accuracy in the reporting of manufacturing data. This commenter pointed out that since the most companies can differ from a calendar year is by six months and IUR reporting occurs every four years (instead of every year), there can be little difference in the data with a six month time frame shift. Other commenters supported the change to a calendar year basis, supporting the idea of having a consistent timeframe to better enable linkages with other databases.

Source: C1-014, C1-028, C1-065

Response F.2-1 : EPA has retained the switch to the calendar year basis as proposed. By moving the collection to a calendar year basis, the IUR data collection becomes more compatible with other databases such as the Toxics Release Inventory (TRI). This compatibility increases the utility of the information by allowing the IUR data to be more easily combined with or compared to information from other collections. It is EPA's belief that most companies are familiar enough with their production volumes that this provision presents no special challenge that are unaccounted for in the burden estimates provided by survey respondents, as described in the economic analysis.

3. Form U comments

Comment F.3-1 : Commenters mentioned that the existing IUR Form U allows ten chemicals to be reported on each form (with an unlimited number allowed on the electronic version), and that each form requires only one certification with one signature for each site, regardless of the number of chemicals being reported by that site. The commenters believed thatPage 139 of 159 this would no longer be the case when using the revised Form U and urged EPA to modify Part I of the revised Form U so that one signature will cover all the chemicals reported by a site.

Source: C1-031, C1-033, C1-061

Response F.3-1 : The certification statement, company information, and plant site identification reported on Part I of the revised Form U will cover all chemicals reported by a single site. Thus, for a given site, submitters will only have to fill out Part I of the revised Form U once, whereas Parts II and III w ill be completed for each individual chemical manufactured (including imported) at that site.

Comment F.3-2 : A commenter objected to the certification that "all information entered on the form is complete and accurate" because submitters may provide estimates where specific information is unavailable. This commenter felt that, due to the nature of estimated information, the submitter cannot attest to the accuracy of the information.

Source: C1-0016

Response F.3-2 : The certification attests to the fact that, to the best of the submitter’s knowledge, the information, including all estimates, is accurate. Although it is true that all estimates are inherently imprecise (i.e. they are not exact), estimates can be accurate (i.e. correct, carefully made). Submitters must maintain the basis for their estimates as part of their overall IUR recordkeeping (see 40 CFR 710.57).

Comment F.3-4 : In section 710.32(c)(4) and (5) of the proposed regulatory text, EPA stated that certain information from calendar year 1999 would be reported under IURA. The year 1999 shouldn’t be used since the first reporting period in 2002 is based on data from 2001, not
1999.

Source: C1-056

Response F.3-4: EPA agrees that, at the time the amendments were proposed, the first reporting year after the promulgation of the IURA was expected to be 2002, based on 2001 data. However, at the time the amendments are promulgated, the first submission period will occur inPage 140 of 159 2006, based on 2005 data. EPA has modified all necessary materials to reflect this, including section 710.52 of the finalized regulatory text.

Comment F.3-5 : One commenter pointed out there is an error in Part III of the sample version of Form U that was provided in the proposed rule. The directions state that Part III should be completed if production is over 100,000 pounds, rather than 300,000 pounds.

Source: C1-027, C1-048

Response F.3-5 : EPA has revised Form U to reflect the 300,000 pound production threshold established for completing Part III of Form U.

Comment F.3-6 : EPA should clarify how sites located in more than one county should report.

Source: C1-033

Response F.3-6 : EPA will clarify in its guidance document for submitters reporting under IURA that, where a site is located in more than one county, submitters should name each of the counties in which the site is located in response to section 710.52(c)(2) of the regulatory text.

G. Economics

Comment G-1 : Commenters disagreed with the Agency’s characterization of the economic analysis results as described in the summary and introductory sections of the Economic Analysis of Proposed Amendments to the TSCA Section 8 Inventory Update Rule (March 1, 1999) (proposed economic analysis) and specifically took issue on the following four points: 1) "On page S-7... EPA in accurately characterizes the proposal by stating that ‘most of these reports must already be submitted under the existing IUR requirements’ when 1,200 inorganic chemicals would be reportable for the first time." 2) The commenter also finds misleading "the Agency's claim that ‘companies would simply be providing additional information’ when considerable economic burden would be placed on manufacturers and importers to assemble use and exposure data on potentially thousands of downstream uses..." and continues the point by stating that "On page S-9 EPA asserts reportingPage 141 of 159 processing and use information on the top ten NAICS codes will cut costs; yet, determining the top ten, perhaps out of thousands, could take considerable effort..." 3) "On page S-13 we must object to EPA's characterization of its decision to seek use and exposure information at the 300,000-pound level as a burden reduction merely because it could have proposed its collection at the 25,000-pound report ing threshold..." 4) "On page II-1 we disagree with the Agency's theory that market externalities preclude the government and the public from access to needed information on risks associated with chemicals. Companies wishing to stay in business have every economic incentive not to use chemicals that might harm their employees or customers. To the contrary, more and more companies are making environmental claims about their products."

Source: C1-016, C1-073

Response G-1 : The specific comments are addressed below: 1) EPA estimates that over 26,800 reports w ill be filed during the first IURA submission period (i.e., in 2006). Of these 26,800 reports, about 4,500 are expected to be from inorganic chemical manufacturers reporting for the first time on approximately 1,200 inorganic chemicals. Roughly 82% of the 25,500 reports are required under the current IUR, therefore EPA’s statement that most of the reports must already be filed under the current IUR is accurate. 2) EPA expects submitters to report information on a wide variety of downstream uses. However, for each chemical on which a submitter reports, that submitter w ill report on a maximum of ten industrial uses. Only an extremely small fraction of chemicals are likely to have thousands of uses, but providing the top ten combinations of NAICS codes and industrial uses, as opposed to thousands, will entail less burden than listing all of them. EPA surveyed chemical firms to estimate the burden required for this data element (see the EA for the final rule). 3) EPA simply meant that providing a partial exemption for chemicals below 300,000 lbs is a concession to burden reduction, and that the Agency has no other basis for creating a separate, higher threshold for the reporting of processing and use information. 4) EPA stands by its statement that market failures (including externalities) preclude the government and the public from access to needed information on risks associated with chemicals. This discussion is presented in Section 2.2 of the EA for the final rule. The existence of certain positive incentives and environmental claims does not begin to address the fundamental lack of data on chemical risk facing the public and EPA. As stated throughout all documents in the public record for this rule, the basic, relatively broad-based information that EPA needs to assessPage 142 of 159 potential risks stemming from chemical production and use is simply unavailable in the marketplace.

1. Burden Comments

Comment G.1-1 : Many commenters expressed concern about the burdens that would be imposed by the IURA. Some felt generally that the Agency’s burden estimates in the Economic Analysis for the proposed IURA were too low. Comments that provided specific criticisms of EPA's economic methodologies are addressed below.

Source: C1-003, C1-010, C1-011, C1-015, C1-016, C1-017, C1-019, C1-020, C1-021, C1-023, C1-026, C1-027, C1-028, C1-031, C1-032, C1-033, C1-036, C1-037, C1-041, C1-048, C1-055, C1-061, C1-073

Response G.1-1 : EPA disagrees with the comments that it has underestimated reporting burden. Few of these commenters provided any evidence as to why they felt EPA underestimated burden, and none provided any specific analytical basis for amending the estimates. These comments generally made unsubstantiated assertions that EPA underestimated burden. EPA surveyed 78 industry respondents to determine burden estimates. The survey instrument, which was developed in 1996, differs from the Form U as it appeared at the time of proposal and as it appears in the final rule docket. These differences required EPA to adjust certain survey responses to fit the requirements of the new regulation. In response to these comments EPA revised the burden estimates for the final rule by instituting more conservative assumptions in interpreting the survey data. This adjustment results in an average total burden (incremental plus baseline) for preparation and submission of a full Form U of 92 to 105 hours for inorganic chemicals in the first reporting year, and 86 to 96 hours for organic chemicals. The methodology is explained in greater detail in the EA for the final rule. There are two important factors to note in interpreting the burden estimate. First, the IUR amendments require that industry report only "reasonably ascertainable" information for most data elements, and "readily obtainable" information for downstream processing and use information; these standards for reporting information were developed after the burden survey was executed. Thus, the survey respondents were reporting burden estimates for a higher standard of information. Second, the UEIP program, which asked respondents to report chemical information very similar to that required by the IUR, also asked respondents to report the time spent of thePage 143 of 159 UEIP form; companies reported a median burden per chemical report of 8 hours, with a mean of 12 hours. (Ref. 32) Throughout the development of these amendments, the Agency considered its need for the information along with industry’s burden in supplying the information. EPA’s view is that the amendments reach an appropriate balance between these considerations.

Comment G.1-2 : Commenters asserted that burdens on the regulated community
associated with IURA will not decrease over time as EPA claims in the EA. Commenters claimed that the four year time lapse between reporting periods will result in changes to product lines and personnel such that a complete reintroduction to reporting will be necessary in each reporting cycle.

Source: C1-016, C1-033, C1-073

Response G.1-2 : EPA disagrees with the comment that a complete reintroduction to reporting will be necessary in each reporting cycle

B some familiarity with reporting is anticipated to remain from cycle to cycle. EPA estimates of burden decrease over time for two reasons: 1) rule familiarization is expected to require the most effort in the first reporting period, and 2) the information reported on Form U is expected to remain similar for many submitters reporting in consecutive periods. EPA agrees that rule familiarization will occur to some extent in each reporting cycle after the first year of reporting due to the four years between reporting, and burden levels in the economic analysis reflect that. But EPA does not believe that the IUR Amendments increase that burden beyond that which is currently experienced under the existing IUR, despite the increased complexity of the Form U (with the exception of inorganic manufacturers). Rule familiarization costs only encompass becoming familiar with rule requirements, and do not include any activities required to complete the revised Form U or otherwise comply with the IURA. Nor does EPA believe that subsequent revised Form Us will be as difficult to prepare as the initial revised Form U. Once a site has completed a Form U, that site will be required to keep its records for five years, which will facilitate familiarization and form completion in future submission periods, and it is extremely unlikely that all information on every Form U will be entirely different in each submission period. EPA has recognized that some information will vary from cycle to cycle, and has incorporated that knowledge into its estimates of future year costs. See Section 3 of the EA for the final rule for more information.Page 144 of 159 Comment G.1-3 : Commenters questioned EPA's estimate that only 1,200 inorganic chemicals will require reporting under this proposal, due to the number of inorganic substances listed on the inventory. One commenter also disagreed with EPA's estimate that it will only take 6 to 8 hours to complete each Form U. The commenter believes that it w ill take at least twice that amount of time for the completion of each form.

Source: C1-020, C1-044

Response G.1-3 : EPA estimates that, in addition to the chemicals that are already reportable under the current IUR, approximately 1,117 inorganic chemicals w ill become IUR reportable under IURA. EPA’s estimate is based on the ratio of inorganic to organic chemicals in the CICIS database. (The CICIS (Chemicals in Commerce Information System) database maintained by EPA contains information collected by the Agency on chemicals in commerce in the U.S. since 1977.) Inorganic chemicals constitute roughly 12% of CICIS, so EPA assumed they would account for the same proportion of chemicals reporting under the IURA, or 1,117 discrete chemicals (see Appendix C of the EA for the final rule for more detail). This figure is only an estimate, as current production data on inorganic chemicals are currently unavailable to the Agency. EPA has no data that would contradict this estimate, nor did the commenters provide evidence or a specific analytical basis that EPA could use for amending the estimate. The commenter obtained the 6 to 8 hour burden figure from Regulatory Assessment Requirements section of the preamble to the proposed rule, which addresses the annualburden per report for each year in the four year reporting cycle (i.e., the total burden of the rule divided by the number of reports, divided by the four years in a reporting cycle). The actual burden per report estimated in the EA for proposed rule was 37 to 46 hours for a full report, for a site currently reporting under IUR (see Table III-12 in the EA for the proposed rule). As described in the preamble to the final rule and the Summary section of the EA, EPA has increased the burden estimates for the final rule 92 to 105 hours for a full report (see Table 3-2 in the EA for the final rule).

Comment G.1-4 : Some commenters felt that the revised Form U represents a 5-, 10-, or 30-fold increase in burden over the current IUR regulations. For example, one commenter writes: "The current single page report covering up to ten chemicals will be replaced by a three page document for each reportable chemical also at each site. This represents a paperwork increase
factor of 30..."Page 145 of 159 Source: C1-010, C1-028, C1-041

Response G.1-4 : EPA disagrees that the rule results in such a significant increase in burden. Under the existing IUR, the estimated average burden for a site to submit a single report is roughly 14 to 22 hours per reporting cycle (including compliance determination, rule familiarization, preparation and submission, and recordkeeping). The IURA exempts some current submitters, adds some new submitters, and would result in an increase in burden for the average report, depending on production volume and type of chemical, of between roughly 19 and 117 hours, in the first year (see Section 3 of the EA for the final rule). The number of pages potentially submitted is an inappropriate measure of the burden of the rule. The commenters have not provided a reasonable basis for their assertions about burden increase. EPA has taken a number of steps to limit reporting burden, including raising the reporting threshold from the existing level of 10,000 pounds to 25,000 pounds, and exempting certain natural gas chemicals from reporting.

Comment G.1-5 : Several commenters claimed that CBI up-front substantiation and reassertion costs are underestimated. For example, one commenter (38) writes: "The proposed rule will require up front substantiation of each CBI parameter ... Furthermore, the requirement that all previous CBI claims, which...may involve thousands of data points, must be reviewed and reasserted each year is unreasonable ..."

Source: C1-016, C1-021, C1-026, C1-028, C1-033, C1-073

Response G.1-5 : Up-front substantiation is only being instituted for one new data element, site ID, not all data elements. EPA surveyed submitters to determine the burden associated with this activity, and believes that its estimates are reasonable. Therefore, the Agency disagrees that it has underestimated the increased burden of up-front CBI substantiation. In response to comments received on the proposed rule, and concerns presented in interagency review, EPA has removed the CBI reassertion requirement from the Final Rule.

Comment G.1-6 : One commenter suggested that EPA must quantify the benefits associated with IURA or, alternatively, give higher priority to less burdensome options.

Source: C1-073Page 146 of 159 Response G.1-6 : EPA is required under Executive Order 12866 to describe the benefits associated with its rulemakings, and makes every reasonable effort to quantify these benefits. In this case however, the benefits of the IURA information collection are impossible to quantify directly. A more complete discussion of the economic benefits of information appears in Section 4 of the EA, but the information provided through the IURA will reduce the costs to EPA, industry, and the public of making decisions about chemical risks, and will improve the expected outcome of those decisions. EPA disagrees that the proposal is overly burdensome, or that it has attempted to short-circuit CBI protections.

Comment G.1-7 : Two commenters suggest that in the economic analysis for the proposed rule, EPA ignored certain company-supplied estimates of burden. One commenter wrote: "we find no statistical reason for excluding these burden estimates and conclude that the burden is higher than indicated in the Economic Analysis..."

Source: C1-021, C1-061

Response G.1-7 : In developing estimates for the EA, EPA surveyed 81 respondents, 3 of which provided burden estimates 19, 35, and 77 times greater than the average for medium and large companies (17, 31, and 69 standard deviations above the mean). The other 78 survey responses ranged up to 5.8 times the mean and 4.4 standard deviations above the mean. While there is no ironclad rule when removing outliers, EPA looked for a significant break that would indicate a problem with the responses. Statistically, these outliers are significant anomalies that could have serious impacts on the results of the survey, and EPA has determined these three responses to be outside reasonable limits. For example, one respondent estimated it would take 12 hours to fill out its address, and 26 hours to fill in a 12-character ID number. Another estimated 780 hours to find the consumer uses for a single chemical. And the third estimated 902 hours to report the percentage of production volume of a single chemical that go to consumer

uses. EPA has no knowledge of the reasons for such a disparity in the responses of these firms, but possible explanations include: 1) the respondents misunderstood the survey (for example, the survey respondents may have been unaware, despit e the instructions, that the survey applied to a single chemical, not to all chemicals produced at a site), 2) EPA's contractor erred, despite strict quality control measures, in reporting survey response s. In neither of these cases is it appropriate for EPA to include such responses.Page 147 of 159 Comment G.1-8 : EPA’s proposal assumes that the current IUR reporting requirements of 11 items of information per reportable CASRN will explode to more than 200 information items per CASRN under the amended rule. However, the current IUR requires a separate "line item" or report for each manufacturing activity, non-site limited volume, and import volume. Thus, IURA would result in over 600 information items potentially being reported, compared to 33
information items under the current rule.

Source: C1-016, C1-026, C1-055

Response G.1-8 : EPA is amending the IUR to provide an accurate and readily available source of basic exposure-related information. Industry’s reporting burden has been limited as much as possible while providing EPA with information necessary to screen for risks to human health and the environment. The maximum number of data elements that could possibly be filled in on the revised Form U for an IUR chemical is roughly 233, 111 of which are simply check boxes for claiming CBI. The vast majority of reports will contain far less than the maximum number of
data elements.

2. Cost comments

Comment G.2-1 : Compliance costs for chemicals manufactured in amounts below the 25,000 lb./yr. production volume threshold are not zero. One commenter writes: "as production approaches the threshold, tracking costs will accrue because there often is no way of ascertaining a priori whether production will exceed the threshold. This position is verified on page III-11 [of the Economic Analysis for the proposed rule] with the acknowledgment in the footnote of the existence of voluntary below-threshold reports."

Source: C1-016, C1-073

Response G.2-1 : Compliance determination (the act of determining the need to comply with a regulation) occurs on a per-site basis, so that the economic analysis assumes all sites that report to the IUR incur the same average cost for determining compliance, regardless of the number of chemicals reported. Some small number of firms that are not required to report to IUR may incur some negligible costs in this regard, but EPA does not believe the costs to be significant as compliance determination is based on production volume, particularly given that it is generallyPage 148 of 159 standard procedure for a business to be aware of the volumes it produces. The existence of voluntary reporters does not imply that below-threshold compliance costs are non-zero; it simply indicates that some firms have chosen to respond to the IUR when not required. EPA has no basis for including costs beyond the requirements of the rule. Additionally, whereas in the past EPA required companies to retain records forming the basis for their decision not to report in a given year, the IURA does not include this recordkeeping requirement for non-submitters.

Comment G.2-2 : Burden estimates for collecting or estimating downstream processing
and use data were too low.

Source: C1-003, C1-011, C1-019, C1-021, C1-027, C1-028, C1-031, C1-037, C1-073

Response G.2-2 : EPA disagrees that its burden estimates for providing downstream processing and use data were too low. EPA surveyed industry respondents to determine burden estimates for downstream processing and use data, which total 79 to 86 hours per report. It is EPA’s expectation that the companies that will file IUR reports can fairly estimate the burdens involved. The methodology used by EPA is explained in greater detail in the EA for the final rule, and the actual survey submissions are in the public version of the official record for this rulemaking. There are two important factors to note in interpreting the burden estimates supplied in response to the burden survey. First, IURA requires that industry report only "readily obtainable" downstream processing and use information; this information standard was considered after the burden survey was executed. Thus, the survey respondents were reporting burden estimates for a higher standard of information. Second, the UEIP program, which asked respondents to report chemical information very similar to that required by IURA, also asked respondents to report the time spent filling out the UEIP form; companies reported a median burden per chemical report of 8 hours, with a mean of 12 hours. No commenters provided specific analysis as to how EPA has underestimated the burden of providing processing and use data, and none provided any basis for an alternative estimate. Therefore, EPA has concluded that its estimates are reasonable.

Comment G.2-3 : Commenters asserted that EPA would be unlikely to make timely use of the volumes of processing and use data that would have to be reported and collected every four years under the rule as proposed. Commenters pointed out that EPA projects its costs under the reporting program would only be $525,000 in the first reporting year and $275,000 in subsequentPage 149 of 159 reporting years, which indicates to them that EPA is not setting aside sufficient funds to allow for timely use of IURA data.

Source: C1-016, C1-055

Response G.2-3 : IURA data will be able to be used in a timely manner. The data will be in a database, which will be readily searchable or downloadable to other programs. EPA use of the data gathered via the IURA is not specifically part of the rulemaking and therefore costs associated with these efforts are not included in the economic analysis for the proposed rule. EPA's need for, and expected use of, the IURA data are documented in the economic analysis, but the costs indicated by the commenter are solely for data collection and management activities as indicated in Section 4 of the EA. Costs arising from use of data are not included in economic analyses, as it is among the Agency’s primary functions to use available data in the course of fulfilling its mission. And it is important to note that IUR data are currently used on a daily basis within the Agency, and provide critical information to a wide variety of programs. Thus, a separate budget line-item for IUR data use would fail to characterize the broad range of situations in which IUR data are, and will continue to be, crucial to EPA's mission. The IURA data may in fact save the Agency resources, because the reported data w ill decrease the time and effort required to estimate chemical use and exposure. The IURA data will increase the quality of data available to EPA, improving the Agency’s ability to make optimal decisions and thus saving

resources.

Comment G.2-4 : EPA projects in its Economic Analysis of the proposed rule that raising the 10,000 lbs./yr reporting threshold to 25,000 lbs./yr w ill eliminate roughly 3, 800 reports for 1,535 chemicals at a savings of $21.3 to $25.8 million in the first year alone. One commenter doubts that these savings will be realized. The commenter could not identify a single instance where the increase in the reporting threshold to 25,000 lbs would e liminate the need to prepare a TSCA IUR report. However, they suggested that perhaps their industry (forest products) is unique in that few, if any, companies will benefit from the increase in the reporting threshold.

Source: C1-011

Response G.2-4 : EPA received roughly 3,800 IUR reports in 1994 for chemicals produced in quantities between 10,000 and 25,000 pounds per site. In 1998 IUR data, which wasPage 150 of 159 unavailable for the proposed rule but was used in the EA for the final rule, the number of organic chemicals produced in volumes between 10,000 and 25,000 pounds was roughly 3,100. Under the rule as finalized, reports of this sort will not have to be filed, generating savings similar to those indicated by the commenter. EPA cannot comment specifically on forest product companies.

Comment G.2-5 : One commenter indicated that the Economic Analysis does not explain why EPA expects to save $21.3 to $25.8 million in the first reporting cycle from raising the 10,000 lbs. reporting threshold to 25,000 lbs., but the Agency projects industry to only incur a cost of $5.1 to $8.5 million in the first reporting cycle by removing the inorganic exemption. In the EA, EPA anticipates that industry will actually end up submitting 4, 500 new reports to address inorganics while subtracting only an estimated 3,800 reports for raising the reporting threshold. In short, EPA is claiming that industry "saves" $6, 789 per report on the one hand (i.e., by raising the threshold), but on the other hand it only "costs" $1,888 to prepare a TSCA report for an inorganic chemical. It appears to the commenter that the agency is either overstating its savings or understating the costs to prepare a TSCA IUR report.

Source: C1-010

Response G.2-5 : EPA has revised the estimated savings to the regulated community from raising the 10,000 lbs. reporting threshold to 25,000 lbs., to $1.8 to$2.9 million per reporting cycle, based on the cost of an IUR report under the existing regulations. The re-estimated costs of removing the inorganic exemption are $6.4 to $9.9 million in the first year (when inorganics are still partially exempt), and $17.8 to $22.0 million in future cycles. See table S-2 of the EA for the
final rule.

Comment G.2-6 : One commenter claimed that EPA either erred or was obfuscating at several points in the economic analysis. "For example, EPA claims that roughly 7,700 reports for 3,200 chemicals w ill be 'eliminated' from the requirement of reporting processing and use exposure information since chemicals produced between 25,000 lbs. and 300,000 lbs. w ill be exempt from this requirement. However, EPA fails to acknowledge that the vast majority of the processing and use exposure information requirements are newly proposed, e.g., exposure
information on downstream customers... More over, EPA... claims co st savings of $16.6 million to $18 million for the elimination of s upplying process and use exposure information on certainPage 151 of 159 petroleum stream chemicals and inorganics. In short, EPA's Economic Analysis appears to contain erroneous assumptions or calculations that distort the true costs of the proposed rule by overstating the cost savings while understating the actual costs to prepare the reports."

Source: C1-011

Response G.2-6 : The figures that the commenter cites are comparisons between the proposed rule and options in which all submitters are required to report the full revised Form U, including the newly-proposed requirements. None of the calculations cited are "erroneous," but a careful reading of the EA is necessary to understand the context in which figures are presented.

3. Benefits Comments

Comment G.3-1 : Several commenters felt the costs of the rule outweigh its benefits, which are not quantified. For example, one commenter writes: "the IUR amendment as now proposed, has only limited benefit to the public, and such benefit has not been demonstrated to justify the anticipated exorbitant cost and burden to industry."

Source: C1-015, C1-016, C1-021, C1-028, C1-038, C1-073

Response G.3-1 : EPA disagrees with this assertion. As stated in the EA for the final rule, the benefits from this rule are unquantifiable on a monetary scale. Despite this, EPA believes that the benefits of increased information on chemical production and use are of substantial benefit to the Agency, and critical to its mandated mission to reduce chemical risk. Benefits from reductions in chemical risk are spread throughout society. Non-EPA users of the data, such as other federal agencies, will also benefit in their service to the American public. EPA has enumerated the
benefits of the rule in more detail in Section 5 of the EA.

Comment G.3-2 : One commenter suggested that EPA has overestimated the benefits of the rule. Underlying EPA's economic analysis is the suggestion that the market does not provide adequate processing and use information on existing chemicals, and that the lack of information requires EPA to amend the IUR. The commenter claims that the economic analysis does not identify any non-regulatory alternatives, and fails to assess the relative costs and benefits of an alternative approach. The commenter also maintains that it is not possible for the public to readPage 152 of 159 EPA's cost-benefit analysis and determine why the proposed option is superior to the other options, and feels that the public is left only with the belief that the Agency "feels" the proposed option is the most cost-effective.

Source: C1-033

Response G.3-2 : EPA recognizes that it is impossible to quantify the benefits of the rule. In the absence of hard benefit figures, it is impossible to make simple comparisons. Thus, EPA must balance the needs of the Agency for data with which to address critical environmental risks, with the burdens of obtaining such data. In doing so, the uses of and need for the data are carefully addressed both within the Agency, and during interagency review. EPA has made every attempt to collect only the information necessary to meet Agency goals, and EPA believes the final rule achieves that objective. Non-regulatory alternatives are discussed in Section 2 of the EA for the final rule. They include taking no direct action or using a voluntary approach. Taking no action and attempting to rely on available information is insufficient (see A Review of Existing Exposure-Related Data Sources and Approaches to Screening Chemicals: Response to CMA ). The shortcomings of a voluntary program, such as UEIP, are discussed at length in the preamble and elsewhere in this
document.

Comment G.3-3 : Several commenters described the environmental benefits of their energy savings programs and stated it is counter-productive for EPA to impose burdens that divert resources away from energy savings efforts. Commenters stated the IURA conflict with other Agency initiatives that include reuse conservation goals. One commenter went on to state that "under a revised IUR, cross-industry or cross-media, including the environmental benefits associated with particular uses of chemicals, are not recognized under a data scheme which focuses only on how many tons of a chemical were used in the past year."

Source: C1-019, C1-035, C1-043

Response G.3-3 : EPA commends industrial groups that are sponsoring energy savings programs and that have reuse conservation goals. EPA recognizes that the IURA will impose a slightly increased burden on industry. However, EPA developed the IURA to provide an accurate and readily available source of basic exposure-related information for about 4,000 of the 76,000Page 153 of 159 substances listed on the Inventory, thus limiting industry’s reporting burden while providing EPA with information necessary to screen for risks to human health and the environment. EPA disagrees that this is counter-productive. Although IURA will not collect information on the environmental benefits that a particular reported chemical may provide, this information is not necessary for EPA to identify and screen potential exposures and risks associated with TSCA chemicals, which is the purpose of the IURA.

4. Small Business Analysis Comments

Comment G.4-1 : Several commenters argued that EPA’s analysis of the impacts of the IURA on small businesses was insufficient to meet the requirements of the Small Business Regulatory Enforcement Fairness Act (SBREFA).

Source: C1-016, C1-016, C1-019, C1-073

Response G.4-1 : EPA’s analysis of small business impacts fully complies with SBREFA. For rules subject to the Regulatory Flexibility Act, which was amended by SBREFA, the Agency is required to undertake specific actions (such as preparing an initial regulatory flexibility analysis and convening a small business advocacy review panel) unless it certifies that the rule w ill not have a significant impact on a substantial number of small entities. As described in the EA, EPA carefully analyzed the impact of the rule on small entities. (The Small Business Administration participated in the Interagency review for the proposed and final rules, and its input was incorporated at both stages.) For both the proposed and final rules, EPA certified that there will not be a significant impact on a substantial number of small entities. EPA notes that it has done
and will continue to do outr each to businesses, including small businesses, for the IURA. It is also important to note three facts: 1) the IUR exempts and IURA will continue to exempt small businesses, 2) the Small Business Administration reviewed EPA's small entity analysis, and 3) had EPA suspected that this rule might have a significant impact on a substantial number of small entities, the Agency would have investigated the matter in much greater detail.

Comment G.4-2 : One commenter suggested that EPA's economic analysis is flawed, as it uses the economic profiles from organic chemical companies to predict economic impacts on sites from a broad range of affected industries. The commenter suggested using industry-specific economic information (e.g., profits) in the analysis.Page 154 of 159 Source: C1-036

Response G.4-2 : The portion of the EA to which the commenter refers is the small entity analysis. EPA’s small entity analysis used economic data from all firms that reported under the IUR in 1994, which represent the vast majority of firms that w ill be required to report under
IURA. EPA believes that it makes more sense to use available data on IUR sites to estimate the impacts of the IURA than to use more generalized data on industry as a whole. EPA uses compliance costs as a percentage of annual sales as an indicator of the severity of economic impact; the type of profit data the commenter suggests are unavailable. In addition, data specific to inorganic chemical manufacturers are also unavailable to EPA, as inorganic chemicals are currently exempt from IUR reporting. EPA has no data that suggest the economic profiles of inorganic manufacturers differ significantly from those of organic chemical
manufacturers.

5. Executive Order 12866

Comment G.5-1 : One commenter claimed that the IURA is inconsistent with Executive Order 12866, in that they felt the proposed rule is not "cost-effective," and the same commenter also mentioned the "Administration’s program on Reinventing Environmental Regulation (March 16, 1995), which calls for environmental protection in a ‘common sense, cost-effective manner’ and a reduction in ‘existing reporting and recordkeeping burden hours by 25%.’"

Source: C1-016

Response G.5-1 : Regarding the requirements of E.O. 12866, EPA believes that IURA represents the most cost-effective method of collecting the data necessary to begin evaluating risks of existing chemicals in commerce. The screening approach enabled by the IURA will allow EPA to target specific situations in which risks may be unreasonable without necessitating a more burdensome chemical-by-chemical review of existing chemicals. The IURA represents the least
burdensome avenue to address risks from chemicals in commerce. The 25% burden reduction target contained in the 1995 Reinventing Environmental Information Report was to be measured across the Agency, not for every individual regulation, program, or Office within EPA. Moreover, the commitment was to reduce the burden of existing regulations; it was not intended to bar new and vital collections such as the IURA. Furthermore,Page 155 of 159 EPA has reduced burden in the IURA by raising the reporting threshold from 10,000 pounds to 25,000 pounds and adding a full reporting exemption for natural gas, reducing the number of reports by about 3,100 and 1,000, respectively. Additionally, many petroleum process streams and certain specifically listed chemical substances are exempt from reporting processing and use
information.Page 156 of 159 References

1. USEPA, “IURA Data Use Plan,” OPPT/EETD, August 23, 2002. 2. USEPA, “A SAB Report: Improving the Use Cluster Scoring System, Recommendations for the Use Cluster Scoring System Prepared by the Environmental Engineering Committee, “Science Advisory Board, SAB-EEC-95-017, September 1995. Also available at www.epa.gov/sab/pdf/eec 95017.pdf. 3. Memorandum from Sandra Zavolta, EPA OPPT, to Heidi King, OIRA OMB, and Kevin Bromberg, SBA, regarding the proposed IUR Amendments – Additional Information Requested 04-27-1999; Attachment E: RM1 Meeting Summary for Methyl Ethyl Ketoxime (MEKO) Summary of a Risk Management 1 (RM1) meeting regarding methyl ethyl ketoxime, provided to the Office of Management and Budget and the Small Business Administration to show how exposure and use information can affect risk management decisions. 03-19-1997. 4. Letter from Stephen A. Newell, Occupational Safety and Health Administration, to Wardner G. Penberthy, EPA, October 15, 1996. 5. Letter from Paul A. Schulte, National Institute for Occupational Safety and Health, to Wardner G. Penberthy, EPA, October 8, 1996. 6. Letter from Michael A. Babich, U.S. Consumer Product Safety Commission, to Wardner G. Penberthy, EPA, June 24, 1996. 7. Letter from Robert Franklin, U.S. Consumer Product Safety Commission, to EPA, December 23,
1999. 8. Letter from Paul A. Schulte, Ph.D., National Institute for Occupational Safety & Health, to EPA, December 21, 1999. 9. General Accounting Office, “Toxic Chemicals: Long-Term Coordinated Strategy Needed to Measure Exposures in Humans,” GAO/HEHS-00-80, May 2, 2000. 10. Letter from Linda Greer, Ph.D., Natural Resources Defense Council, to Carol Browner, U.S. EPA, February 12, 1999. 11. USEPA, ``EPA Needs Exposure-Related Data: A Discussion of the Justification for Collecting Exposure-Related Data Through the IUR Amendments,'' OPPT/EETD/EPAB, 1998. 12. USEPA, ``Reducing Risk: Setting Priorities and Strategies for Environmental Protection,'' Science Advisory Board, (SAB-EC-90-021), 1990. 13. National Academy of Public Administration, ``Setting Priorities, Getting Results - A New Direction for EPA,'' 1995. 14. Letter to James Aidala, EPA, from Sandra Tirey, CMA, “Tier 1 Exposure Data in the EPA Voluntary Children’s Safety Program,” Docket Number OPPTS-00274, March 24, 2000. 15. Sandra Tirey, Inside EPA’s Risk Policy Report, Jan 24, 2000, vol 7, No 1. 16. USEPA, ``Inventory Update Rule (IUR) Amendment Technical Support Document:Page 157 of 159 Exposure-Related Data Useful for Chemical Risk Screening,'' Volumes 1 and 2, OPPT, July 19, 1996. 17. General Accounting Office, ``EPA Should Focus Its Chemical Use Inventory on Suspected Harmful Substances,'' GAO/RCED-95-165, July 7, 1995. 18. E-Mail from James M. Boiano, NIOSH, to Susan Sharkey, OPPT/EPA, "Status of NIOSH NEWS" October 24, 2002. 19. USEPA, "U.S. Chemical Production, Use, and Exposure Data: A Study of Existing Information Sources," OPPT, Oct 1, 1997. 20. USEPA, “Draft Instructions for 2006 Inventory Update Rule Reporting Under the Toxics Substances Control Act (TSCA),” OPPT, August 2002. 21. USEPA, ``Inventory Update Rule (IUR) Technical Support Document: Selection of Consumer and Commercial End-Use Categories,'' OPPT, 1996. 22. USEPA, ``Economic Analysis of Proposed Amendments to the TSCA Section 8 Inventory Update Rule,'' OPPT/EETD/EPAB, March 1, 1999. 23. USEPA, “Revised Economic Analysis for the Amended Inventory Update Rule,” OPPT, August
2000. Date will need to be updated 24. USEPA, ``A Review of Existing Exposure-Related Data Sources and Approaches to Screening Chemicals: A Response to CMA,'' OPPT, March 1999. 25. USEPA, “Methodology Used for the Initial Selection of Chemicals for the Inventory Update Rule Amendments (IURA) ‘Low Current Interest’ Partial Reporting Exemption,” OPPT, July 24, 2002. 26. USEPA, “Inorganic Chemicals: Sources of Information Suggested by Commenters to the Proposed Inventory Update Rule Amendments,” OPPT, June 2000. 27. Letter from John DeYoung, Chief Scientist, U.S. Geological Survey, to Mary Ellen Weber, EPA, July 25, 2002. 28. USEPA, “Clarification of the Interpretation of 'Article' Under TSCA," OTS, October 1, 1985. 29. USEPA, "Report to Congress: Wastes from the Combustion of Fossil Fuels," OSW, April 25, 2000, available at http://www.epa. gov/epaoswer/other/fossil/index.htm. 30. Confidential Business Information Data Review, Georgia Department of Natural Resources, Docket entry 00125 B2a-010 filed June 19, 1996, page 4. 31. Letter from Mark N. Duvall, Union Carbide, to EPA, ``Additional Comments of Union Carbide Corporation on EPA's Preliminary Actions to Reform TSCA Confidential Business Information, Docket No. OPPTS-00125,'' August 31, 1993. 32. USEPA. 1997b. UEIP-ICR Database. Summary table.Page 158 of 159 Appendix 1: Docket Commenter Number Cross Reference List of Legacy Docket to E-Docket

Each comment summary is followed by a list of sources used to compile the comment. The sourcenumbers refer to the legacy docket from the proposed rule (Docket #82503). The Agency now has an EDocket (Docket # OPPT-2002-0054), which incorporated the legacy docket but uses a new numbering system. Below is a table providing a cross-reference between the two docket numbering systems.

Legacy Docket E-Docket Legacy Docket E-Docket

C1-001 0148 C1-041 0191

C1-002 0159 C1-042 0192

C1-003 0150 C1-043 0193-0196

C1-004 0151 C1-044 0197-0201

C1-005 0152 C1-045 0202

C1-006 0153 C1-046 0203

C1-007 0154-0156 C1-047 0204

C1-008 0157 C1-048 0205-0209

C1-009 0158 C1-049 0210

C1-010 0159 C1-050 0211

C1-011 0160 C1-051 0212

C1-012 0161 C1-052 0213

C1-013 0162 C1-053 0214

C1-014 0163 C1-054 0228

C1-015 0164-0165 C1-055 0216

C1-016 0166 C1-056 0217

C1-017 0167 C1-057 0218

C1-018 0168 C1-058 0219

C1-019 0169 C1-059 0220

C1-020 0170 C1-060 0221Page 159 of 159 C1-021 0171 C1-061 0222

C1-022 0172 C1-062 0223

C1-023 0173 C1-063 0224

C1-024 0174 C1-064 0225

C1-025 0175 C1-065 0226

C1-026 0176 C1-066 0227
C1-027; 027(1) 0177; 0231 C1-067 0215

C1-028 0178 C1-068 0229

C1-029 0179 C1-069 0230

C1-030 0180 C1-070 0231

C1-031 0181 C1-071 0232

C1-032 0182 C1-072 0233

C1-033 0183 C1-073 0234

C1-034 0184

C1-035 0185

C1-036 0186

C1-037 0187

C1-038 0188

C1-039 0189

C1-040 0190