HPV Chemical Hazard Data Availability Study
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
Of the 3,000 chemicals that the US imports or produces at more than 1 million lbs/yr, a new EPA analysis finds that 43% of these high production volume chemicals have no testing data on basic toxicity and only seven percent have a full set of basic test data. This lack of test data compromises the public's right to know about the chemicals that are found in their environment, their homes, their workplace, and the products that they buy. Industry must do more to ensure that basic information is available on every high-production chemical they manufacture.
There are six basic tests which have been internationally agreed to for screening high production volume (HPV) chemicals for toxicity. The tests agreed to under the Organization for Economic Cooperation and Development's Screening Information Data Set (OECD/SIDS) program are: acute toxicity; chronic toxicity; developmental/reproductive toxicity; mutagenicity; ecotoxicity and environmental fate.
EPA found that approximately 55% of TRI chemicals have had full SIDS testing, while only 7% of other chemicals have full test data. EPA also looked at a set of 491 chemicals used by children and families in consumer products. Only 25% of these chemicals have full screening data. EPA cannot begin to judge the hazards and risks of such consumer chemicals without basic information, and in fact substantially more detailed and exhaustive testing is needed to assess these high exposure chemicals.
It is clear that companies need to do more to address this problem: of the 830 companies making HPV chemicals in the US, 148 companies have NO SIDS data available on their chemicals; an additional 459 companies sell products for which, on average, half or less of SIDS tests are available. Only 21 companies (or 3% of the 830 companies) have all SIDS tests available for their chemicals. The basic set of test data costs about $200,000 per chemical.
EPA will announce results of study in April 1998 and issue a challenge to industry to come forward with complete test data for these HPV chemicals followed by the proposal of test rules to fill remaining data gaps by the end of 1999.
What do we really know about the safety of High Production Volume
Chemicals? EPA's Chemical Hazard Data Availability Study finds major gaps
in the basic information that is readily available to the public.
CHEMICAL HAZARD DATA AVAILABILITY STUDY
o The U.S. produces or imports close to 3,000 chemicals (excluding polymers and inorganic chemicals) at over 1 million pounds per year.
o Most Americans would assume that basic toxicity testing is available and that all chemicals in commerce today are safe. A recent EPA study has found that this is not a prudent assumption.
o EPA has reviewed the publicly available data on these chemicals and has learned that most of them may have never been tested to determine how toxic they are to humans or the environment.
o International authorities agree that six basic tests are necessary for a minimum understanding of a chemical's toxicity. These tests, called the Screening Information Data Set (or SIDS), cover: acute toxicity;chronic toxicity, developmental and reproductive toxicity; mutagenicity; ecotoxicity; and evironmental fate.
o 93% of these 3,000 high production volume chemicals are missing one or more of these basic tests.
o 43% of these chemicals are missing ALL of these tests.
o Only 7% of these chemicals have all six of the most basic screening tests.
This report presents the results of EPA's analysis of test data availability for 2,863 organic chemicals produced or imported at or above 1 million pounds per year in the United States. Details of the search strategy will be provided in a forthcoming report on EPA's analysis, including a chemical-by-chemical presentation of the hazard information available to the public on each of the US High Production Volume (HPV) chemicals. While the SIDS tests do not fully measure a chemical's toxicity, they do provide a minimum set of information that can be used to determine the relative hazards of chemicals and to judge if additional testing is necessary.
o 203 of these HPV chemicals appear on the TRI list. One would expect TRI chemicals to be relatively well tested, but in fact, there are numerous testing gaps. About 54% of these high volume TRI chemicals have all six of the basic screening tests and all of the TRI HPV chemicals have at least some data available -- about 20% of the HPV TRI chemicals were missing 2 or more of the basic SIDS tests. (A number of these chemicals are also pesticides, but, this analysis did not consider information developed under FIFRA). On the other hand, the majority of the HPV chemicals not listed on TRI lack the basic information needed to determine if they should be listed on TRI (e.g., 46% of the non-TRI listed HPV chemicals have no data available and less than 4% have the full set of basic tests.
o The picture is somewhat brighter for the high exposure potential TRI HPV chemicals. 91 of the 203 TRI HPV chemicals were reported as having total on-site and off-site releases at levels greater than 1 million pounds (for the 1995 reporting year). Of these 91 high release HPV TRI chemicals, 74% have information available on all six basic SIDS tests. All of the high release HPV TRI chemicals have data available from at least three of the SIDS tests. Nonetheless, given the large releases, it is clear that testing beyond the basic SIDS level is necessary to adequately understand the risks of such high exposure chemicals (refer to the related announcement on "Kids Testing" to see EPA's approach to dealing with this issue).
o OSHA sets Permissible Exposure Limits (PELs) for hazardous chemicals in the workplace. One would expect that chemicals with PELs have been thoroughly tested at least for human health effects, but even the high volume chemicals with PELs have significant data gaps from the human health portion of the basic screening test set. Only 53% of these high volume chemicals with PELs have basic screening tests for all four of the human health endpoints. In contrast, only 5% of the non-PEL HPV chemicals had all four health effects tests and 49% had no health test data available. Thus, it is clear that the bulk of HPV chemicals without PELs lack even the minimal data needed to support development of a PEL value to protect workers.
o Chemicals contained in consumer products are of concern due to the likelihood of their exposure to children, as well as other sensitive populations. Fortunately, the industry has completed basic testing for more of these chemicals than is the case for other HPV chemicals -- of the 491 HPV chemicals listed on EPA's Indoor Air Source Ranking Database, 25% have data publicly available for all six SIDS tests, while only 7% have no data available. Nonetheless, as for the high release TRI chemicals, given the great exposure potential of consumer products and the fact of children's exposure, significantly greater amounts of testing are needed to assess the risks of such chemicals (once again, refer to the related announcement).
o Chemical companies need to do more to deal with this problem: of the 830 companies making HPV chemicals in the US, all of the HPV chemicals produced by 148 companies have NO SIDS data available (i.e., 0/6 SIDS tests are available), an additional 459 companies sell products for which, on average, 3/6 or fewer of the SIDS tests are available , while for only 21 companies (or 3% of the 830 companies) can it be said that all SIDS tests (6/6) are available for all of their chemicals.
o For each chemical, the basic set of six screening tests costs about $205,000.
o It would cost the chemical industry less than $427 million to fill all of the basic screening set data gaps for the high production volume chemicals. This represents 0.2% of the total annual sales of the top 100 U.S. chemical companies. (Sales figure of $231 billion in 1996 from Chemical and Engineering News, May 1997)
Download the Chemical Hazard Data Availability Study HAZCHEM.PDF (118kb) in portable database file (.pdf) format. This file requires the Adobe Acrobat Reader (see below)
Variable names for each column are shown in the first row of the database. The remaining rows contain the information on hazard data availability for the chemicals. The first column (CAS.NO) contains the Chemical Abstract Services registry number, which is a unique identification number assigned to a chemical. The name of the chemical is displayed in the second column (CHEMICAL). An "X" is shown in the third column (ACUTE), if EPA was able to locate any information on acute toxicity testing. Columns 4 (CHRONIC), 5 (TERARE), 6 (MUTAGEN), 7 (ECOTOX), and 8 (FATE) are also marked with an "X" if hazard data were located for chronic toxicity, teratogenicity or developmental/reproductive toxicity, mutagenicity, ecotoxicity, and environmental fate, respectively. The total number of six hazard test data endpoints located for each chemical is shown in Column 10 (TOTAL).
Some 277 of the 2863 US HPV chemicals are part of the ongoing OECD SIDS international program. Some of the SIDS testing is complete, but many of those studies have not yet been entered into publicly accessible databases, although all of the information will be available in the future as those databases are updated. A "C" or "U" is marked in Column 9 (SIDS) if the chemical is part of the OECD SIDS testing program. A "C" indicates that testing has been completed, and a "U" denotes that testing is ongoing. Copies of completed SIDS dossiers are available through the United Nations Environmental Programme (UNEP, 1996). The Master Summary Table will be updated to include the SIDS information once the hazard data become available.
Additional columns in the table indicate whether the chemical is a high release TRI chemical (TRI HIGH), whether the chemical is on the 1995 TRI database (TRI), whether an OSHA PEL (OSHA PEL) is in place for the chemical, and whether the chemical is a consumer product chemical (CPC) listed in EPA's Source Ranking Database.
Download the Master Summary for the Chemical Hazard Data Availability Table USHPVWEB.PDF (542kb) in portable database file (.pdf) format. This file requires the Adobe Acrobat Reader (see below)
Download the Master Summary for the Chemical Hazard Data Availability Table USHPVWEB.DBF (608kb) in database file (.dbf) format. This file requires a database application program such as Approach, FoxPro, dBase, etc.
Click here to download the Acrobat Reader from the Adobe Homepage. Certain files with complicated tables or graphics are formatted in Portable Data Format (PDF) to ensure that the original layout and graphics are maintained. A special reader is required to read these files. This reader can be downloaded, free of charge, by clicking on the icon.