New Chemicals Program

Fourteen formulations of chemical alternatives were submitted to EPA under confidentiality and they were assessed based on numerous human health and ecotoxicity endpoints in addition to bioaccumulation potential and environmental persistence. They were also screened for potential exposure to workers, users and the aquatic environment. Where data gaps existed, EPA experts used models and chemical analogs to estimate the hazard for a particular endpoint. The literature and test data reviews were published in the final report, Environmentally Preferable Options for Furniture Fire Safety Low Density Furniture Foam . In addition, each hazard endpoint was ranked with a concern level (High, Moderate or Low) based on the criteria used by the EPA s New Chemicals Program to rate the concern level of new chemicals submitted under the Toxic Substance Control Act (TSCA). As seen in Figure 8.2, where the hazard endpoint rankings are bold, the value is based on experimental data. Where the hazard endpoints are presented in italic font, the value is estimated based on models or chemical analogs. In this way, detailed hazard information was summarized and presented in a clear and concise format. 

Newborn jaundice, photochemical treatment of, 79 120 New chemicals, pricing of, 75 641-642 New Chemicals Program (EPA), 9 456 New Drug Application (NDA), 27 574 New drug approval (NDA) process, 78 698-701... 

The US-EPA s New Chemicals Program, located in the OPPT, was established to help manage the potential risk from chemicals new to the marketplace. The program is mandated by Section 5 of TSCA. 

US-EPA. 2006c. The United States Environmental Protection Agency Toxic Substances Control Act New Chemicals Program website, www.epa.gov/opptintr/newchems US-EPA. 2006d. United States Environmental Protection Agency Test guidelines, http //www.epa. 

U S Environmental Protection Agency (EPA) (2002) TSCA New Chemicals Program (NCP) Chemical Categories (revised October, 2002) http //www.epa. gov/oppt/newchems/pubs/cat02.pdf (last accessed 14 September 2011). 

In all cases, the DfE Program used the expertise of the EPA s New Chemicals Program to understand the chemistry and potential fate and toxicity of chemicals of concern and potential safer alternatives while engaging the key stakeholders to ensure the five facets of informed substitution are considered and safer alternatives are feasible for all parties. The DfE Program has had other successes in partnering with industry and others to reduce risks of chemicals. Information about these projects can be found at www.epa.gov/dfe. 

The Canadian new chemicals program uses two chemical inventories, the Domestic Substances List (DSL) and the Non-Domestic Substances List (NDSL). The DSL includes substances that were, between January 1, 1984, and December 31, 1986, in Canadian commerce, used for manufacturing purposes, or manufactured in or imported into Canada.17 It contains about 23,000 substances. One of the initiatives in the Canadian Environmental Protection Act, 1999 (CEPA, 1999) requires the Minister of the Environment and the Minister of Health to categorize (Section 73, CEPA 1999) and then if necessary, conduct screening assessments (Section 74, CEPA 1999) of substances listed on the DSL to determine whether they are toxic or capable of becoming toxic as defined in the Act. The NDSL is a list of substances not on DSL but in commerce elsewhere in the world.18 The NDSL contains more than 58,000 entries. 

When TSCA became law, there was no list of chemicals then used in the United States. Thus a vital first step was compilation of a comprehensive inventtsy of chemical substances in commercial production. As chemicals pass through the new chemicals program, they are added to the TSCA inventory. As of 1991, there were about 70,000 chemicals on the inventory [9]. 

More than 18,000 PMNs have gone through EPA s new chemicals program [lOJ. Between 1979 and 1991, >10% of PMN chemicals were banned or restricted, pending receipt of additional data, or were voluntarily withdrawn by the submitter because of Agency concerns. 

Roswell, F Toxic Substances Bull., Health and Safety Executive, 1992, 20, 1-2. Office of Toxic Substances, United States Environmental Protection Agency, new chemicals program intervention to prevent risk is program s basis. Chemicals in Progress Bull., 1991,12, (4), 6-7 and 30. 

For several years, the EPA has been developing and refining its program regarding the regulation of nanoparticles, particularly under the New Chemicals Program and Section 5 of TSCA. The subjects discussed below represent the most current of EPA s published opinions. 

Since 1979, EPA s New Chemicals Program has reviewed almost 30,000 new chemicals, including 22,000 PMNs, which were fully reviewed and 5500 low-volume, test market, and polymer exemptions. During this period, the Agency claims that the TSCA has prevented potential risks to people and the environment from nearly 2700 new substances. 

EPA s Draft Questions 8t Answers for the New Chemicals Program. 1-61, question 122-1 (undated), [hereinafter Draft PMN Q8cA] available at http //www.epa.gov/oppt/newchems/ pubs/qanda-newchems.pdf. 

In its Draft Questions Answers for the New Chemicals Program the EPA confirms that this type of analytical error would result in a PMN violation. It suggests that if some batches do not meet the requirements for the polymer exemption then either more testing or another strategy would be required to assme compliance. ... 

Fed. Reg. 21721, 21725 (May 13. 1983) EPA Draft Instruction Manual for Reporting Under the TSCA 5 New Chemicals Program. 6-7 (2003) [hereinafter PMN Instruction Manual], available through http //www.epa.gov/oppt/newchems/. 

EPAs Draft Questions Answers for the New Chemicals Program (undated) PMN QScA Draft PMN Q A... 

Fed. Reg. 76282 (Dec. 11, 2002) Sustainable Futures—Voluntary Pilot Project Under the TSCA New Chemicals Program Notice 67 FR... 

EPA Draft Instruction Manual for Reporting under the TSCA 5 New Chemicals Program (2003) PMN Instruction Manual... 

Fed. Reg. 16336 (Mar. 29, 1995) Premanufacture Notification Exemption Revision of Exemption for Chemical Substances Manufactured in Small Quantities Low Release and Exposure Exemption Final Rule 60 FR 16336 LVE LoREX 3-29-95 64 Fed. Reg. 31987 (June 15, 1999) Recordkeeping Requirements for Low Volume Exemption and Low Release and Exposure Exemption Technical Correction 64 FR 31987 LoREX 6-15-99 67 Fed. Reg. 76282 (Dec. 11, 2002) Sustainable Futures—Voluntary Pilot Project Under the TSCA New Chemicals Program Notice 67 FR 76282 Sustainable 12-11-02... 

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