TSCA 8 a Reports

Second, EPA could issue rules under S 8(a) to require periodic reports concerning the commercial development of certain new substances once they enter production. Unlike SNUR s, S 8(a) requirements would not prevent companies from continuing their production and marketing activities. Rather, EPA would review information contained in the 8(a) reports, and then could pursue control actions under its other TSCA authorities for regulating existing chemicals (i.e. 4 test rules, or 6(a) "unreasonable risk" regulat ions). 

EPA does not know the exact number and chemical composition of commercially available nanomaterials. It has the authority to gather this information through the reporting requirements of TSCA 8(a) and has announced its intent to provide a notice of proposed rulemaking for this purpose in 2010. ... 

Any person who submitted the information required by the lUR in compliance with a TSCA 8(a) rule within one year of the start of a reporting period is not again required to report on the manufacture of that substance at that site during that submission period." When two or more importers are involved in a particular import transaction, they may determine among themselves who should submit the required report. However, each such importer will be Hable for failure to report if no report is filed." ... 

TSCA 8(a) authorizes EPA to promulgate rules requiring manufacturers and importers of certain chemical substances and mixtures to maintain records and submit reports of production volumes, distribution, use, and human exposure under the Preliminary Assessment Information Rule (PAIR) and Inventory Update Reporting (lUR) Rule ... 

The information to be included on the form is intended to gather very preliminary exposure data to permit the Agency to assess testing priorities.i When promulgated in 1980, PAIR was intended by EPA to be the first of a series of progressively more detailed reporting rules under TSCA 8(a) to establish a comprehensive assessment of chemical substances."... 

C.RR. 716.5. In 1998, EPA narrowed the scope of persons subject to TSCA 8(d) reporting to generally exclude processors as part of regulatory reform, concluding that narrowing the scope of persons covered would have but a negUgible impact on the type and comprehensiveness of information submitted. 63 Fed. Reg. 15765 (Apr. 1,1998). 

Once a chemical substance or mixture is added to the rule, the reporting period typically terminates sixty days after the effective date of the listing. Importers who bring chemicals into the United States as part of articles are subject to TSCA 8(d) reporting rules. The 8(d) rules apply to importers and the definition of importer includes any person who brings a chemical substance into the U.S. as part of a mixture or an article. The EPA s call for health and safety data on lead in children s toys is an example of an 8(d) rule that clearly is intended to include importers of chemical substances in articles. In the preamble to that rule, the EPA said ... 

Once a substance is listed for TSCA 8(d) reporting, existing studies are required to be reported within sixty days. The ITC will review the submitted information to assess whether test data are sufficient or whether a recommendation for testing should be made. If a study is initiated within the sixty day period, notification to EPA of study initiation must be provided. Upon completion of such an initiated study, the study must be submitted to the Agency within thirty days, regardless of the expiration of the initial sixty day reporting period. ... 

The TSCA 8(e) reporting obligation appUes to any person engaged in the manufacture, import, processing, or distribution in commerce of the chemical substance at issue. The term person is defined by the Agency to include natural persons, business entities (a firm, corporation, sole proprietorship, joint venture, partnership, or association), any State or poUtical subdivision... 

It is also important to note that it is not uncommon for a chemical substance to have a use that is both within and without TSCA s jurisdiction depending on the markets into which the chemical substance is sold. For example, a chemical substance sold for cosmetic application alone would be outside TSCA jurisdiction and toxicity data generated in relation to the substance would not be subject to potential TSCA 8(e) reporting. If the same chemical substance is also sold for industrial application then it is subject to TSCA and reporting of substantial risk information is mandatory. One must keep in mind as well that markets do not remain static. The toxicity data concerning a chemical substance that was not submitted last month on the basis that the sole application of the substance was as a cosmetic may become immediately reportable this month when the substance is sold into a different application. 

The Court in Dow Chemical Co. v. PA, 605 E2d 673 (3rd Cir. 1979) found that the processing, import, or manufacture of small quantities of chemicals for research and development purposes was a commercial purpose and was therefore within the scope of 8 of TSCA the 8(e) Comment Document, 34, Usts the citations for EPAs assertions that research and development materials are subject to TSCA 8(e) reporting. 

Because the penalties continue to accumulate on a daily basis, it is sometimes prudent to submit 8(e) information even if the product is not currently being sold for a TSCA use. If there is a likelihood that the substance will become subject to TSCA, many companies choose to report the information under TSCA 8(e) to avoid the very difficult management procedures that would be required to track when such exempt substances become subject to the TSCA 8(e) reporting requirement. There is no penalty for reporting something that does not need to be reported. 

Even if a benchmark is exceeded, a study is not subject to TSCA 8(e) reporting unless the environmental distribution is extensive. The EPA gave examples in its 2006 Frequent Questions, and said that a spill of thousands of pounds of a toxic chemical that migrates to groundwater and may result in drinking water contamination is reportable. However a relatively small spill that was cleaned up before it could result in substantial distribution to the environment would not be reportable. Applying this same logic, the EPA... 

Substantial risk information that must be reported to EPA must be submitted immediately, a term that has no statutory definition in TSCA. In its 2003 Reporting Guidance, EPA stated that a person has immediately informed the Administrator if human health information is received by the EPA not later than the thirtieth calendar day after the date the person obtained such information. The EPA has said it is not sufficient for the submittal to be postmarked within thirty days, and it is up to the submitter to ensure that the EPA receives it within the required time frame. Emergency incidents of environmental contamination must be reported to the EPA by telephone as soon as the person has knowledge of the incident. That could be on the order of minutes or hours, but it would be difficult to argue that waiting a full day is contemplated. If the information is required to be, and has been, reported under another statute administered by EPA, such as CERCEA, the TSCA 8(e) report is unnecessary. Any supplementary information must also be reported immediately. 

TSCA 8(e) reports are made pubfic, and if the fact that a company is investigating a specific chemical could reveal trade secrets, certain information in the submittal can be marked as confidential. 

For a discussion of TSCA 8(a) PAIR rules, see Chapter 7, Reporting and Recordkeeping. 

All the PMBs are Hsted on the U.S. EPA s Toxic Substances Control Act NonConfidential Chemical Substances Inventory (Table 8). In the early to mid-1980s, pseudocumene, mesitylene, hemimellitene, and trimethylbenzene were coveted by TSCA Section 8(a) Preliminary Assessment Information Rule (PAIR) reporting requirements (22) and by TSCA Section 8(d) for health and safety data (23). Mesitylene is the subject of a test rule subacute oral toxicity and subchtonic oral toxicity in tats were underway in 1994 (24). The Safe Drinking Water Act (SDWA) allows monitoring for pseudocumene and mesitylene at the discretion of the State (25). Of the PMBs, only pseudocumene is subject to SARA Tide III section 313 annual release reporting (26). 

This was the first part of TSCA which impacted the industry. The responsibility of 8(e) reporting has been with the industry since Day One of TSCA. While not required to, the Agency did publish a guidance document in March of 1978 to assist industry in understanding its responsibilities. To date, some 400 notices have been submitted to the Agency. While the Agency has followed up with the notifiers, no other action has been taken by the Agency to date on the chemicals involved. 

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 TSCA Inventory, established under Section 8(b) ofthe Act, comprises substances considered to exist in US commerce. A substance not already included on the Inventory is considered to be a new chemical substance pursuant to TSCA Section 3(9). Under TSCA Section 5(a), a person must submit a Premanufacture Notification (PMN) to the EPA at least 90 days before commencing manufacture or import, for a commercial purpose, of a chemical substance not on the Inventory, unless the substance is exempt from reporting. After PMN review and upon receipt of a Notice of Commencement of Manufacture or Import (NOC), the EPA adds the chemical substance to the Inventory, which then becomes an existing chemical substance. Certain nanoscale substances that will be manufactured or imported for commercial purposes are expected to be new chemical substances and therefore subject to the TSCA new chemical reporting requirements, as are any other new chemical substances. 

Nanomaterials are subject to all of the TSCA regulatory programs. As a result, substantial risks presented by nanomaterials must be reported to the EPA under TSCA 8(e) and allegations of significant adverse reactions must be... 

RESPONSE EPA agrees that they would not normally be reportable because the exposure is not widespread and previously unsuspected. However, if health or environmental effects are seen then reporting should be considered. Also, if the substance has started the regulatory review process under FIFRA it would not be subject to section 8(e) reporting. A chemical substance which is in the process of R D as a pesticide is subject to TSCA until such time as the manufacturer or importer demonstrates the intent to produce a pesticide by submitting to the Agency an application for an Experimental Use Permit or registration under FIFRA. 

Before a company files an EUP it may research the pesticidal properties of a chemical substance. In those cases, if the R D activities are focused on investigating substances potential for use as pesticides, then the company does not need to comply with TSCA s restrictions on managing of R D chemicals. If the company does other types of research in addition to research on pesticides, then it must show by some affirmative evidence that its only intent with respect to the chemical at issue is to develop it as a pesticide. As a consequence, pesticides can be exempted from the premanufacture notification requirements of TSCA 5 even before an EUP is filed, but the substance will be subject to other TSCA requirements, such as reporting significant adverse effects under TSCA 8(e). 

Any person who manufactures a new chemical substance must comply with the premanufacture notification requirements of TSCA 5, the reporting and recordkeeping requirements of 8, and the testing requirements of 4. 

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