Health and safety studies

TSCATS is an online index to unpublished, nonconfidential studies covering chemical testing results and adverse effects of chemicals on health and ecological systems. The studies are submitted by US industry to EPA under several sections of the Toxic Substance Control Act (TSCA). There are four types of documents in the database Section 4 chemical testing results, Section 8(d) health and safety studies, Section 8(e) substantial risk of injury to health or the environment notices, and voluntary documents submitted to EPA known as a For Your Information (FYI) notice. 

Section 8(d) governs EPA acquisition of health and safety studies. It authorizes EPA to promulgate rules requiring any person who manufactures, processes or distributes in commerce any chemical substance or mixture, or proposes to do so, to submit lists and/or copies of health and safety studies. EPA may exclude... 

Submit lists of health and safety studies conducted or initiatied or known to, or reasonably ascertainable and when required submit actual copies of studies... 

Monsanto s experience with information-gathering and reporting under section 8(d) - Health and Safety Studies - has not been as rewarding as the inventory activity. On July 8, 1978 EPA issued a Final Rule requiring submission of lists and copies of... 

Technical. Additional technical support in companies other than testing personnel will arise from the need for additional recordkeeping, such as the annual reports and TSCA inventory ( 8(a) and (b)), records of significant adverse reactions to health or environment ( 8(c)), records of applicable health and safety studies ( 8(d)), and notices of substantial risk to health or environment ( 8(e)). In larger... 

The final element of this federal impact on confidentiality is that certain laws require certain things to be made public. The Toxic Substances Control Act has several useful confidentiality provisions in 14, but it adversely affects confidentiality when it prohibits the EPA withholding of health and safety "studies." That term is not well defined at all. There are conflicting views about which items are "studies." From a careful reexamination of the law, I feel that identity can be confidential and need not be part of a study, if the... 

Reporting - EPA can require chemical manufacturers to report certain types of data which will enable the Agency to more effectively assess the risks associated with particular substances. This includes information on chemical identity, use, production volume, exposure, and existing health and safety studies. 

Testing - EPA can require manufacturers to perform health and safety studies on specific chemicals or categories of chemicals that the Agency feels may present an "unreasonable risk to human health or the environment."... 

TSCATS Toxic Substances Control Act Test Submissions 4,200 submissions on 2,228 substances ENVIRONMENTAL PROTECTION AGENCY Unpublished health and safety studies submitted to the EPA. Provides a mechanism for ordering microfiche copies of studies... 

The term health and safety study is intended to be interpreted broadly and means any study of any effect of a chemical substance or mixture on health or the environment or on both, including but not limited to ... 

Provides over 64 000 citations to unpublished health and safety studies, chemical tests, and substantial risk data on over 8400 chemical substances submitted to the US EPA under the Toxic Substances Control Act (TSCA). Copies of the original submissions are available from the US EPA (CIS, subset of TOXLINE available on CD-ROM in PolTox I and Toxline from Silver Platter). 

TBBPA is listed in the Environmental Protection Agency Toxic Substances Control Act under Section 8(b) and as a result all manufacturers, importers and processors of TBBPA are required to report all health and safety studies that they have conducted. As... 

IT Corporation. 1985. Phase II site assessment, Broadview, Illinois Plant. TSCA Health and Safety Studies. 8D submission 878216377. 

HaSDR rules require producers and importers to submit to the U.S. EPA copies and lists of certain types of unpublished health and safety studies for the listed chemicals. Submitters under the HaSDR rule are also requested to provide robust summaries of health and environmental effects studies. In addition, when the ITC designates chemicals for testing, the U.S. EPA is required to initiate proceeding under a TSCA Section 4(a) test rule, if the PAIR and HaSDR data trigger a finding of unreasonable risk of injury to health or the environment. 

Data from the toxicology base, plus those from the additional Health and Safety studies that are sometimes required, allow for the... 

Although there is no prohibition on claiming that health and safety studies are CBl, the EPA may not refuse a Freedom of Information Act request for health and safety studies that were submitted with PMNs. ° Confidential process information and confidential information concerning the composition of mixtures may not be released, but other than that health and safety studies may not be withheld on the ground that they are CBL Even if the... 

The provisions of TSCA 8 require reporting information to the United States Environmental Protection Agency (EPA) about production of chemicals, studies showing significant adverse effects, and health and safety studies. 

TSCA 8(d) authorizes EPA to promulgate rules requiring manufacturers, importers, and processors to submit lists of health and safety studies in their possession, known to them, or initiated on specific chemicals substances and... 

TSCA 8(d) requires the EPA to promulgate rules requiring manufacturers, importers, processors, and distributors to submit lists and copies of unpublished health and safety studies on specified chemicals or mixtures. Those studies must be listed or submitted if they were conducted or initiated by or for the manufacturer, importer, processor, or distributor, known to such person, or reasonably ascertainable by such person. The intent of the regulations is to give EPA information to determine the need to issue test rules under TSCA 4, restrictions on use under TSCA 5, or prohibitions on the manufacture, use or distribution pursuant to TSCA 6 on the basis that the chemical substance or mixture presents an umeasonable risk of harm to human health or the environment. 

The import of children s products that contain lead or lead compounds constitutes the manufacture of lead or lead compounds under TSCA. EPA believes importers of such products are the entities most likely to have the type of health and safety studies EPA is seeking. ... 

Pursuant to the 1998 amendments to its rule, EPA will specify the types of health and safety data requested in its rulemaking as well as the chemical grade and purity of the chemical substance for which reporting is required. If the manufacturer or importer possesses a copy of a study, it must submit it. If the manufacturer or importer has knowledge of a study but not a copy, it must identify the study in a list submitted to EPA. The Agency has defined health and safety study broadly to include ... 

EPA s position is that all unpublished health and safety studies are report-able, regardless of the objectives of developing the data. ... 

However, although many companies claim CBI for large portions of 8(e) submittals, TSCA 14(b) provides that health and safety studies on chemicals that have been offered for distribution in commerce are not confidential under TSCA. EPA has said it will not keep confidential the results of these studies, or the chemical identities of the test substances. Although in practice the EPA has abided by claims that submissions contained CBI, on January 21, 2010 it issued a policy stating that as a general practice it will reveal the names of chemicals that are the subject of 8(e) reports if the chemicals are on the publicly available version of the Inventory. When 8(e) reports are submitted with a claim of confidentiaHty for the chemical identity of a substance on the nonconfidential Inventory, the EPA will write to the submitter and state that it has found that the chemical identity is not entitled to CBI treatment. The submitter may appeal that determination. 

Other TSCA information gathering requirements are triggered by a chemical s appearance on the Priority Testing List. The Preliminary Assessment Information Reporting (PAIR) regulations mandate that EPA require manufacturers and importers to submit PAIR information on chemicals that the ITC recommends for consideration. The PAIR rule requires a quick and dirty collection of readily obtainable information on a chemical s use and properties. Similarly, the 8(d) health and safety study regulations require... 

The United States Environmental Protection Agency (EPA) has promulgated regulations under the Toxic Substances Control Act (TSCA) to protect from disclosure to third-parties confidential business information (CBI) submitted to the Agency. The statutory provision requiring EPA to create protections for CBI is TSCA 14. TSCA 14 defines the nature of the CBI that should be maintained in confidence by reference to the Freedom of Information Act, which in turn protects information from disclosure if it consists of trade secrets and commercial or financial information obtained from a person and privileged or confidential. Examples of information considered CBI under TSCA include chemical formulas, material inputs identification, process information, chemical substance identities, company names, site locations, and volumes of substances manufactured, imported, or processed. The EPA may make pubHc any information claimed as CBI in health and safety studies on substances or mixtures that have been offered for commercial sale or for which testing is required under 4 or for which notification is required under 5. However, EPA cannot disclose process information or information about the proportion of chemical substances in a mixture. ... 

A) any health and safety study which is submitted under this chapter with respect to-... 

B) any data reported to, or otherwise obtained by, the dministrator from a health and safety study which relates to a chemical substance or mixture described in clause (i) or (ii) of subparagraph (A). 

The Chemicals in Commerce Information System (CICIS) is being designed to support regulatory decision making within the EPA Office of Toxic Substances. CICIS will contain data on substance identification, uses, production volume, disposal methods, health and safety studies, and exposure data. The TSCA inventory is part of CICIS. 

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