Discussion of the 2006 Inventory Update Reporting Data NEWMOA June 14, 2007 Fredric C. Arnold U.S. EPA T/Y Lorraine AND Good afternoon. Self Intro - [We just heard some perspective from an industry member, Scott Belanger, regarding the development and use of HPV data @ P&G in a day to day decision making and chemical management strategy setting] - Unlike the previous presentation and probably most of the presentations at this conference which focus on the HPV or hazard based data, this presentation is a little different. The focus of my presentation is on the Inventory Update Reporting or IUR data and not HPV data. - For those who are not familiar with the IUR rule, the data collected is quite unique and has its own utility including possible use in combination with HPV data for various purposes including exposure characterization of chemicals. - With that, NEXT SLIDE

Presentation Overview What is IUR? What data were collected? Who was required to report? Where can one find historical IUR information? How will IUR data be used? Your input/suggestions on uses of IUR data - This is an overview of my presentation which consists of primarily two parts: the first deals with the IUR itself and its their data collection requirements (including what is the IUR, what data was collected, who needs to report, and where you can find the information) - And then the second part deals with how the data can be used, including its use in combination with HPV data. - And finally, I hope to have a few minutes at the end of my talk AND instead of me talking, I would like to hear from you any suggestions you may have on the use of IUR information. - OK! NEXT SLIDE

The Inventory Update Reporting (IUR) collects information from chemical manufacturers and importers on the manufacture, industrial processing and use, and commercial and consumer use of chemical substances on the TSCA Inventory. The IUR provides a “snapshot” of chemical manufacturing every 5 years. - The picture provided by the IUR rule is quite unique. - It provides EPA and other users an overview of the chemical use and exposure related information for chemical substances in the U.S. - Previously, this snapshot was taken every four years. Recently, many changes were made to the IUR requirements. And One of these changes was to extend the reporting period from every four to now five years. - Manufacturers & importers are reporting information on the materials produced and/or imported during calendar year 2005. - NEXT SLIDE

The TSCA Inventory lists industrial or commercial chemicals in commerce in the United States. Currently there are over 82,000 substances on the Inventory. - The Inventory was first developed in the late 1970’s. As chemicals are developed and entered into commerce in the US, they are added to the Inventory. Over the years, the Inventory has grown to over 82,000 chemicals. - I should note that Not all chemical substances are included on the Inventory. Substances used only as pesticides, for food or cosmetic purposes, or as ammunition are not included. - NEXT SLIDE

What chemical substances are included in the IUR? Organic and inorganic chemicals that are: Currently listed on the Inventory; and Manufactured or imported at volumes of at least 25,000 pounds at a single site. Exceptions include: Polymers; Microorganisms; Naturally occurring substances; Certain forms of natural gas; and Substances produced as a byproduct or impurity. - So what chemical substances are included in the IUR. - The current IUR, finalized in Dec. 05, covers both organic & inorganic chemicals. - Substances produced or imported volumes of 25,000 pounds or more at a site are required to report – this contrasts with the 1 million pound requirement for inclusion in the HPV Challenge program. As many of us know, the 1 million pounds is an aggregate, national figure for a chemical substance AND is not a single site figure like the IUR data. - On the previous slide, I showed there are over 82,000 chemicals on the TSCA Inventory, information will be collected on just over 9,000 chemicals.  - There are some substances for which information was not collected in IUR: - Polymers (….def….e.g. _) and microorganisms (i.e. living organsms) are not required to report. - Substances that are only naturally occurring (e.g. rocks, ore and minerals) are not required to report. [manner in which it is produced e.g. mechanical, manual separation, by dissolution of water by flotation, or by heating solely to remove water) - There are 6 forms of natural gas – [natural gas (petroleum), raw liquid mix ; natural gas condensates ; gasoline natural ; gasoline (natural gas), natural ; natural gas ; natural gas, dried] that are exempt from reporting. - And also, substances that are produced as a byproduct or impurity - And lastly, there are a couple of other exceptions not listed here. 1)      If chemical is imported as part of an article. 2)      If chemical is manufactured or imported solely for R&D] - NEX SLIDE  

Manufacturing Data Collected Chemical identification information: Chemical name Numerical identification (i.e., CAS Registry Number) Manufacturing information: Production volume Site-limited status Manufacturing or Import activity Number of potentially exposed workers Physical form, w/ associated percent production volume Maximum concentration - As mentioned, IUR information is collected on a per site, per chemical basis. All sites that manufacture >25,000 lb/yr of a TSCA chemical substance are required to report chemical and manufacturing information listed on this slide. - The IUR submitters are required to provide basic chemical identification information, which include Chemical Abstracts Index/Preferred Name and a chemical identifying number such as the CAS Registry Number, PMN number, or the Accession Number (if chemical is confidential). - IUR submitters are also required to report other exposure related information for the manufacturing site including: PV, site limited status, manufacturing or import activity, # of potentially exposed workers, physical form with associated % PV and maximum concentrations. - Ranges are used for some of the data elemnts such as the numbers of workers and maximum concentrations are reported in ranges. - NEXT  

Industrial Processing and Use Data Production Volume Threshold 300,000 pounds per year or more Partially Exempt Chemical Categories: Manufacturers & importers of these partially exempt chemicals/categories report only site and manufacturing data Categories of chemicals include: Inorganic chemicals (for 2006 reporting only); Multi-chemical petroleum process streams (specifically identified); and Specifically listed chemical substances for which there is a low current need for IUR processing and use information. - In addition to the 25,000 lbs trigger for reporting of manufacturing information, for chemicals manufactured or imported in quantities @ 300,000 lb/yr or more, submitters are also required to report additional industrial processing and use information which I will get into in the next couple of slides. - Note that there are certain categories of chemicals that are partially exempt from reporting downstream information on processing & use information and what that means is that the submitters only need to report manufacturing information and are “partially exempt” from reporting processing and use information. - AND These partially exempt categories include: - Inorganic chemicals for this reporting year only. [This is the first time that manufacturers of inorganic chemicals were required to report to the IUR, and the Agency limited their reporting to only manufacturing data to give the industry an opportunity to learn about the IUR and to allow EPA to learn about reporting issues for this industry. Subsequent reporting cycles may require additional processing and use information.] SLIDE 7 (CON”T) - Multi-chemical petroleum process streams. [These are typically complicated streams that have very limited use and known exposure issues.] - The last category includes a number of chemicals for which there is a low current interest for IUR processing and use information. [Low current interest chemicals are chemicals for which the Agency believes there currently are adequate data to satisfy IUR data needs. However, the Agency reserves the rights to revisit the adequacy of data in the future. There are currently 94 substances on the list.]

Processing and Use Data Collected Up to 10 unique combinations of: Type of processing or use NAICS code (5-digit) Industrial function category (bleaching agent, filler, lubricant, etc) For each unique combination: Percent production volume (range) Number of sites (range) Number of potentially exposed workers (range) - In terms of reporting processing and use information, submitters are required to report such information for up to the top ten unique combinations of the three data elements including type of processing or use (e.g. processing as a reactant, or incorporation into formulation), the NAICS code (similar to the SIC code), and the industrial function category e.g. bleaching agent, lubricant). - For each of these unique combinations, the manufacturer also reports, in ranges, the the percent production volume, the number of sites, and number of potentially exposed workers.   SLIDE 8 (CON”T) [NOTE ONLY: # of sites - less than 10 ; 10 - 25 ; 25 - 100 sites ; 100 - 250 ; 250 - 1,000 ; 1,000 - 10,000 ; 10,000 or more sites Again, the % PV is rounded to the closest 10% and the # of workers is reported in ranges] [5 types of processing or use categories: Processing as a reactant (PC) Processing - incorporation into formulation, mixture or reaction product (PF) Processing - incorporation into article (PA) Processing - repackaging (PK) Use - non-incorporative activities (U) - NAICS codes – 5-digit codes representing the types of uses. NAICS code 32619 - Other Plastic Product Manufacturing. HMDA is used as a reactant to produce polyamide for use in plastic products.) - IF category – 33 different categories – for example - Adsorbents and absorbents (U01) ; Adhesives and binding agents (U02) ; Coloring agents, dyes (U07 or 08) ; Flame retardants (U12); Plating agents and metal surface treating agents (U22); Solvents (for chemical manufacture and processing and are not part of product at greater than one percent by weight) (U27, 28, or 29); Surface active agents (U31)]

Consumer and Commercial Use Data Collected Use category (automotive care product, lawn & garden product, soaps & detergents, etc) For each use category: Indication of intention for use by children (14 yrs & under) Maximum chemical concentration Percent of production volume - The IUR rule also collects information on consumer and commercial uses such as automotive care product, soaps and detergents, etc.) . - For each of the use category reported, the submitter also need to provide: indication as to whether the product is intended for use by children (under the age of 14), the max. conc. of the chem in the product and the % of the PV [rounded to the nearest 10%]. - [20 categories of consumer and commercial uses – for instance: Adhesives and sealants (C01); Agricultural products (non- pesticidal) (C02); Artists' supplies (C03); Leather products (C09); Photographic supplies (C14); Wood and wood furniture (C19 - [NOTE: Although these data are considered “downstream processing” and may not be readily obtainable, to some IUR submitters, EPA believes that for competitive business reasons, most submitters will possess considerable insight on the final use of their chemicals.]

IUR Reporting Standards Source of information Manufacturer of chemical substance Importer of chemical substance Reporting Standards Manufacturing data is “known to or reasonably ascertainable by” Processing and use data is “readily obtainable” Consumer and commercial use data is “readily obtainable” - I’d like to mention briefly about the reporting standards under the IUR. - Since the information submitted under the IUR comes from manufacturers or importers, the rule has a different standard for the reporting of manufacturing information versus the downstream processing and use information. - The standard of reporting of manufacturing information is “known to or reasonably ascertainable by” the submitter. - So Information that is possessed by employees working in technical support, research or marketing or company brochures, etc. are considered to be known to or reasonably ascertainable. - Downstream processing and use information including consumer and commercial use activities are less known to the submitter and are reported only if it is readily obtainable by the submitter. - This standard is a lesser standard than the “known to or reasonably ascertainable” and allows submitters to supply “readily obtainable” information using professional judgment and experience. [If an IUR submitter does not have the necessary information for any data under this standard, they may simply respond “NRO” for not readily obtainable.] e.g. known to management or supervisory people is “readily obtainable” -         NEXT

Who submits IUR data? Persons who manufacture or import chemicals with: Production volume of 25,000 lbs or greater (annual, per site) report site and manufacturing data. Production volume of 300,000 lbs or greater (annual, per site) report additional processing and use data. Inorganic chemical manufacturers and importers: Partial exemption for the first reporting cycle and only report site and manufacturing data. After the first reporting cycle, required to report as described for chemical manufacturers and importers above. - We just talked about the data requirements. This slide discusses the submitters of the IUR informaiton. - As shown here and previously mentioned, reporting is trigered by PVs and there are 2 triggers. - For an individual site with PV @ 25,000 lbs or greater, the submitter needs to report site and manufacutring information. - For an individual site with PV @ 300,000 lbs or greater, the submitter needs to also report downstream processing & use information. - I should note here that import and manufacture are synonymous under the IUR. Therefore, a chemical’s import volume and its manufactured volume will be added together to determine the reporting requirements. - Again there is a partial exemption for the inorganic chemical manuifactures and importers for the first reporting cycle currently occuring. - After the first reporting cycle, the partial exemption is no longer in effect and full reporting is required for inorganic chemicals.

Small businesses are exempt from reporting Who submits IUR data? Small businesses are exempt from reporting TSCA Definition of Small Businesses Total annual sales, including parent company, less than $40 million and annual site production volume less than 100,000 lbs OR Total annual sales, including parent company, less than $4 million. -- This slide shows one category of submitters, the small businesses, who are exempt from reporting under the IUR. - The slide shows the definition of small business as defined under TSCA. [NOTE ONLY: The TSCA definition is different than the SBA definition, which is much broader and industry-specific.] - [NOTE ONLY: When determining whether a company meets the IUR definition of a “small business”, submitters will only use the IUR chemical of concern when looking at total sales and the annual site production volume (not all chemicals manufactured or sold). Some exceptions may be voided if the IUR chemical of concern is under other regulatory action (test rule, etc).]

Historical Information is Available IUR data collection began in 1986 and occurred every four years. IUR data was limited to organic chemicals. IUR data was limited to chemical identity, production volume, and site-limited status. Non-confidential chemical records are available under “Past IUR Data” on our website: www.epa.gov/oppt/iur - IUR data colection began in 1986 and previously occurred every 4 years. - For those who may be interested in historical IUR information, the data collected from 1986 through 2002 is available. - Note that the universe of chemicals collected previously was limited to organic chemicals. - AND The data was limited to chemical identity, PV and site limited status. - The IUR website, as listed here, has a page that provides a searchable database of the IUR historical information. - The database contains non-confidential company and chemical records for 1998 through 2002. - OK. This completes the first part of my presentation which is an overview of IUR - NEXT SLIDE.

How do HPV, and TRI chemicals relate to IUR? > 600 chemicals >210 HPV chemicals - I thought it is interesting and as a transition into the second part of my presenation, to provide a snapshot of how HPV and TRI chemicals related to the universe of IUR chemicals. - This picture shows that essentially all HPV chemicals generally have to report under the IUR. {Recall I said that PV triggers for IUR reporting, which is site-specific, is @ 25,000 lbs and 300,000 lbs and PV trigger for HPV, which is an aggregate #, is 1MM lb/yr aggregate.} - The picture also shows that many TRI chemicals also have to report under the IUR and that there are about 200 chemicals belong to both TRI and HPV data collection efforts. - OK. NEXT SLIDE  

IUR data may be used in Risk Screening: Risk = f (Hazard, Exposure) HPV data provides hazard information. IUR data provides exposure related information that may be used in combination with other models and data to: Determine potential screening-level occupational/public risk. Determine potential screening-level environmental risk. IUR Exposure Data HPV Hazard Data TRI, other OPPT tools - So we now are going to discuss some of the uses of the IUR information and my hope is that these suggested uses will stimulate your thinking and hopefully you can share your ideas with us at end of my presentation. - One potential use of the information is in Risk Screening/priority setting. - As we all know, risk screening involves information on hazard and exposure. - HPV provides information on the hazard component of the risk equation. - IUR data, as shown here, when use in combination with other information e.g. TRI release information and other OPPT tools provide the information for the exposure component and together with HPV data, could facilitate risk screening. - Depending on the interest and purpose, screening level screening could be done for occupational, general population or environmental risk. - NEXT SLIDE Risk Screening

Exposure Estimations Using IUR Data Some information provided by IUR: Information on industrial function category, NAICS code and type of processing or use information Production volume Number of sites Number of workers Maximum concentration of chemical Physical state of chemical % PV used in commercial and consumer use categories The information, along with P/C properties from HPV Challenge Program, may be useful inputs to models (e.g. ChemSTEER) to determine potential environmental releases and exposures to workers Similarly, IUR and HPV data may be useful inputs to E-FAST model to determine potential exposures to consumers - IUR data can also be useful for developing screening level exposure estimates - Again, listed here are some of the exposure related information being collected under IUR which include: information on industry category and functional use, the PV, # of sites, # of workers reasonably likely to be exposed to the chemical, the physical form(s) of the substance as it leaves the facility; the percentage of the total production volume associated with each physical form; and the maximum concentration of the chemical substance, the commercial and consumer uses and the %PV associated with each of the use; and NOT LISTED HERE is the indication of the presence of the substance in consumer products intended for use by children. - This exposure related information, along with the P/C properites (e.g. from HPV Program), may provide useful inputs to models (e.g. ChemsTEER which is one of the models we use in OPPT) to determine optential environmental releases and occupational exposures. - Similarly, IUR and HPV data may provide useful inputs to another model called EFAST to determine potential exposures to consumers. I should also mention that the releases from ChemSTEER are also used by EFAST to predict general and env. exposures. - NEXT SLIDE

Priority Setting/Occupational Risk Screening Using IUR Data Prioritize chemicals based on exposure related criteria (e.g. # of potentially exposed workers) In combination with HPV data, could prioritize chemicals based on both hazard and exposure related criteria Flag chemicals within certain industry sectors with high potential exposure for further follow-up activity. - This slide and the next provide examples of the use of IUR data for various priority setting or screening purposes. - This slide is about using IUR information specifically for occupational exposure screening using such data as # of potentially exposed workers. - AND one can develop various types of priortization and ranking approaches based on different combinations of data elements. - IUR data could also be combined with HPV data to prioritize / screen chemicals based on both hazard and exposure related criteria - Another potential application of the IUR data is to flag chemicals within certain industry sectors with high potential exposure for further follow-up activity. [NOTE: # of workers and NAICS codes, et] NEXT

Priority Setting / Consumer and/or Children Risk Screening Using IUR Data Prioritize chemicals based on exposure related criteria (e.g. use in consumer products, use in products intended for children) In combination with HPV data, could prioritize chemicals based on both hazard and exposure related criteria Flag chemicals within certain consumer product categories with high potential exposure for further follow-up activity. - This slide is similar to the previous one although the screening applications are different. - Instead of using IUR data for occupational exposure screening, one can use IUR data for screening purposes based on potential exposure to consumers or to kids. - Again, you could prioritize / screen chemicals using data elements from IUR in combination with hazard information from HPV. - And you can use the data to flag chemicals specifically for potential consumers exposure and/or potential exposures to children. - NEXT

Other Potential Uses of IUR Data Design for Environment (DfE) Identify potential safer substitutes IUR information on use category in combination with low concern in hazard screen (using HPV data) could provide list of possible safer substitutes Occupational Safety and Health Administration (OSHA) Identify manufacturing and import sites when the need arises to provide alerts for specific chemicals based on identified hazards and the need for warnings. - And here are a couple more potential uses of IUR data. - IUR could be used for P2 application such as Design for environment or DfE activity and specifically for identifying potential safer substitutes - AND for those who would like to hear more about the DfE program, there is another presentation by one of my colleagues tomorrow in session 5A I believe. - IUR information on use category in combination with low concern in hazard screen (using HPV data) could provide list of potential safer substitutes for use in a DfF type of activity. - Another idea is that IUR information could be useful for outreach purposes e.g. OSHA alerts which can be based on IUR information on # of sites and # of workers reasonably likely to be exposed to certain chemcals. -         NEXT

Other Potential Uses of IUR Data The IUR provides information that can be used as a starting point for basic exposure information. Some potential uses include: Enabling a “first look” at a chemical, industry, or use by providing needed information not otherwise available. Enabling a more proactive rather than reactive approach by providing information needed to identify trends and upcoming issues or concerns. Providing a starting point for more in-depth analyses and identifying where additional information may be needed. Placing hazard information into context, such as information collected through the HPV Challenge Program and similar programs. - This slide lists other potential uses of the IUR data. - For example, the data enables a “first look” at a chemical, industry or use by providing need information not otherwise available e.g. PV. - The data could facilitate a more proactive rather than reactive approach to risk screening by providing information needed to identify trends and upcoming issues or concerns. AND we talked about this. - It provides a starting point for more in-deptth analyses. - AND finally, it provides information that places hazard info. e.g. HPV data into context. - Before I conclude so that we can hear from you on your ideas and suggestions, I would like [FLIP TO NEXT SLIDE} to briefly mention about a brainstorming idea that is being discussed in our office.

2006 IUR Data Release Report Still in the planning stages Initial thoughts include tables such as: National and state breakdowns Number of chemicals reported, total pounds Number of reporting facilities Number of manufacturers Number of importers Number of high volume chemicals Chemical name and CAS numbers Primary uses and commercial product categories Top 100 chemicals by physical state Chemicals used in consumer products Chemicals used in children’s products Worker information By chemical By number of workers potentially exposed - AND what we have been discussing is development of a 2006 IUR Data Release Report. - I would like to emphasize this is very much a brainstorming idea at this time. - Some of the initial thoughts for what to include in the report consist of various tables such as: - Tables showing the breakdowns of information by states and regions e.g. # of chemicals reported, the total pounds produced, # of reporting facilities # of manufacturers. - Tables # of importers, # of high volume chemicals by name and/or CAS #s and PVs, - A table of top 100 chemicals by physical state, - Chemicals used in consumer products, and or children’s products - and worker information by chemical. - Again, this is very much an idea at this time. - AND that’s all I have. [FLIP TO LAST SLIDE]

Incorporating IUR Information in the HPV Chemical Screening Process Summarize use and exposure information for HPV chemicals Identify populations reasonably likely to be exposed to a HPV chemical Prioritize HPV chemicals by numbers and classes of individuals reasonably likely to be exposed Prepare a screening level assessment Here are some of the ways in which we can use the IUR and HPV information together For each HPV chemical substance, we can develop an exposure profile identifying the volume of the chemical produced, the uses of a chemical substance, and the populations of individuals exposed to a chemical substance. IUR information can be used to identify chemicals with significant numbers of workers reasonably likely to be exposed to the substance, those chemicals to which the general population is exposed, and those HPV chemicals used in products intended for children. IUR information can be used to prioritize HPV chemicals by exposure profile. And IUR information can be used to prepare a screening level exposure assessment.

Your suggestions for other potential uses of IUR data arnold. fred@epa Your suggestions for other potential uses of IUR data arnold.fred@epa.gov - Any suggestions for other potential uses of IUR data or Input on our idea on the 2006 IUR Data Release Report.