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Regulatory Actions for Year 2008


Agency for Toxic Substances and Disease Registry (ATSDR)

Notice Type Title Summary of Notice NTP Information Cited CASRN
Notice Availability of Draft Toxicological Profiles The Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA), as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA), Section 104(i)(3) [42 U.S.C. 9604(i)(3)], directs the Administrator of ATSDR to prepare toxicological profiles of priority hazardous substances and to revise and publish each updated toxicological profile as necessary. This notice announces the availability of the 22nd set of toxicological profiles, which consists of four updated drafts prepared by ATSDR for review and comment. The toxicological profiles for formaldehyde and perfluoroalkyls are on a modified schedule pending additional review.

November 06, 2008 -- 73 FR 66047
The profiles must also include a determination of whether adequate information on the health effects of each substance is available or in the process of development. When adequate information is not available, ATSDR, in cooperation with the National Toxicology Program (NTP), is required to ensure the initiation of research to determine these health effects. NA

California Office of Environmental Health Hazard Assessment (OEHHA)

Notice Type Title Summary of Notice NTP Information Cited CASRN
Notice Chemical Listed Effective June 17, 2008 as Known to the State of California to Cause Cancer, Dibromoacetic acid (CAS No. 631-64-1) The Office of Environmental Health Hazard Assessment (OEHHA) within the California Environmental Protection Agency is adding dibromoacetic acid (CAS No. 631-64-1) to the list of chemicals known to the state to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Health and Safety Code section 25249.5 et seq., commonly known as Proposition 65). The listing of dibromoacetic acid is effective June 17, 2008. Toxicological endpoints: Reproductive Toxicity and Cancer

June 13, 2008 -- Proposition 65
National Toxicology Program (NTP, 2007). Toxicology and Carcinogenesis Studies of Dibromoacetic Acid (CAS No. 631-64-1) in F344/N Rats and B6C3F1 Mice (Drinking Water Studies). NTP Technical Report Series No. 537. NIH Publication No. 07-4475 631-64-1
Notice Final Public Health Goal for Copper in Drinking Water This Public Health Goal (PHG) technical support document provides information on health effects from copper in drinking water. PHGs are developed for chemical contaminants based on the best available toxicological data in the scientific literature. These documents and the analyses contained in them provide estimates of the levels of contaminants in drinking water that would pose no significant health risk to individuals consuming the water on a daily basis over a lifetime.

February 08, 2008 -- Public Health Goals
NTP (1993) Technical Report on Toxicity Studies of Cupric Sulfate (CAS No. 7758-99-8) Administered in Drinking Water and Feed to F344/N Rats and B6C3FX Mice. NIH Publication 93-3352; Research Triangle Park, NC 27709 7758-99-8

Consumer Product Safety Commission (CPSC)

Notice Type Title Summary of Notice NTP Information Cited CASRN
Notice Standard for the Flammability of Residential Upholstered Furniture The United States Consumer Product Safety Commission (Commission or CPSC) is proposing flammability standards for residential upholstered furniture under the Flammable Fabrics Act (FFA). The proposal would establish performance requirements and certification and labeling requirements for upholstered furniture. Manufacturers of upholstered furniture would choose one of two possible methods of compliance: They could use cover materials that are sufficiently smolder resistant to meet a cigarette ignition performance test; or they could place fire barriers that meet smoldering and open flame resistance tests between the cover fabric and interior filling materials. Manufacturers of upholstered furniture would be required to certify compliance with the standard and to comply with certain recordkeeping requirements as specified in the proposal.

March 04, 2008 -- 73 FR 11702
At the request of the staff, the National Toxicology Program (NTP) of the Department of Health and Human Services has undertaken a review of several FRs that could be used to meet CPSC flammability rules. The NTP review will be a relatively long-term project that contributes to the overall level of knowledge about FR chemicals among scientists and regulators. NA

Environmental Protection Agency (EPA)

Notice Type Title Summary of Notice NTP Information Cited CASRN
Final Rule Diflubenzuron; Pesticide Tolerances for Emergency Exemptions This regulation establishes time-limited tolerances for combined residues of diflubenzuron and its metabolites p-chlorophenylurea and p-chloroaniline in or on alfalfa, forage and alfalfa, hay. This action is in response to EPAs granting of an emergency exemption under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide on alfalfa and mixed grass/alfalfa fields. This regulation establishes a maximum permissible level for residues of diflubenzuron and its metabolites p-chlorophenylurea and p-chloroaniline, in these food commodities. The time-limited tolerances expire and are revoked on December 31, 2011.

November 28, 2008 -- 73 FR 72352
There are two metabolites of diflubenzuron; PCA and CPU. PCA tested positive for splenic tumors in male rats and hepatocellular adenomas/carcinomas in male mice in a National Toxicology Program (NTP) study. (TR-351) 20265-96-7
Final Rule Inert Ingredient: Exemption from the Requirement of a Tolerance for (S,S)­Ethylene­di­amine­di­succinic Acid This regulation establishes an exemption from the requirement of a tolerance for residues of (S,S)­Ethylene­di­amine­di­succinic Acid (CAS Reg. No. 20846-91-7) ((S,S)EDDS) when used as an inert ingredient sequestrant or chelating agent in pesticide formulations applied to growing crops only under 40 CFR 180.920. Associated Octel Company, Limited, submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of (S,S)Ethylenediaminedisuccinic acid.

November 14, 2008 -- 73 FR 67397
No carcinogenicity studies are available on (S,S)EDDS, however, NTP tested trisodium EDTA in mice and rats showed no carcinogenic potential. Based on its similarity with EDTA and lack of mutagenicity, (S,S)EDDS is not likely to be carcinogenic to humans at low doses. (TR-011) CAS No. 150-38-9
Final Rule National Ambient Air Quality Standards for Lead Based on its review of the air quality criteria and national ambient air quality standards (NAAQS) for lead (Pb), EPA is making revisions to the primary and secondary NAAQS for Pb to provide requisite protection of public health and welfare, respectively. With regard to the primary standard, EPA is revising the level to 0.15 μg/m3. EPA is retaining the current indicator of Pb in total suspended particles (Pb-TSP). EPA is revising the averaging time to a rolling 3-month period with a maximum (not-to-be-exceeded) form, evaluated over a 3-year period. EPA is revising the secondary standard to be identical in all respects to the revised primary standard.

November 12, 2008 -- 73 FR 66964

Lead has been classified as a probable human carcinogen by the International Agency for Research on Cancer (inorganic lead compounds), based mainly on sufficient animal evidence, and as reasonably anticipated to be a human carcinogen by the U.S. National Toxicology Program (lead and lead compounds). ROC

NA
Notice Sixty-Third Report of the TSCA Interagency Testing Committee to the Administrator of the Environmental Protection Agency; Receipt of Report and Request for Comments The Toxic Substances Control Act (TSCA) Interagency Testing Committee (ITC) transmitted its 63rd Report to the Administrator of the EPA on October 7, 2008. In the 63rd ITC report, which is included with this notice, the ITC is revising the TSCA section 4(e) Priority Testing List by removing 1 tungsten compound and 1 High Production Volume (HPV) Challenge Program orphan chemical.

November 03, 2008 -- 73 FR 65486
At this time the ITC is removing tungstate (WO42-), disodium, dihydrate, (T-4)-, a.k.a. disodium tungstate (Na2WO4) dihydrate (CAS No. 10213-10-2) from the Priority Testing List because of the voluntary information provided by the International Tungsten Industry Association and their cooperation in a National Toxicology Program/National Institute for Occupational Safety and Health research program to address exposure and toxicity data needs. 10213-10-2
Final Rule Control of Emissions From Nonroad Spark-Ignition Engines and Equipment We are setting emission standards for new non-road spark-ignition engines that will substantially reduce emissions from these engines. The exhaust emission standards apply starting in 2010 for new marine spark-ignition engines, including first-time EPA standards for stern-drive and inboard engines. The exhaust emission standards apply starting in 2011 and 2012 for different sizes of new land-based, spark-ignition engines at or below 19 kilowatts (kW). These small engines are used primarily in lawn and garden applications. We are also adopting evaporative emission standards for vessels and equipment using any of these engines. In addition, we are making other minor amendments to our regulations.

October 08, 2008 -- 73 FR 59034
The International Agency for Research on Carcinogens (IARC) has determined that benzene is a human carcinogen and the U.S. Department of Health and Human Services (DHHS) has characterized benzene as a known human carcinogen. (ROC)

The IARC has determined that 1,3-butadiene is a human carcinogen and the U.S. DHHS has characterized 1,3-butadiene as a known human carcinogen. (ROC)

Acetaldehyde is reasonably anticipated to be a human carcinogen by the U.S. DHHS in the 11th Report on Carcinogens and is classified as possibly carcinogenic to humans (Group 2B) by the IARC. (ROC)

The National Toxicology Program listed naphthalene as "reasonably anticipated to be a human carcinogen" in 2004 on the basis of bioassays reporting clear evidence of carcinogenicity in rats and some evidence of carcinogenicity in mice. (ROC)
71-43-2
106-99-0
75-07-0
91-20-3
Other Dichlorvos (DDVP); Order Denying NRDCs Objections and Requests for Hearing In this order, EPA denies objections to, and requests for hearing on, a prior order denying a petition requesting that EPA revoke all pesticide tolerances for dichlorvos under section 408(d) of the Federal Food, Drug, and Cosmetic Act. The objections and hearing requests were filed on February 1, 2008, by the Natural Resources Defense Council (NRDC). The Original petition was also filed by NRDC.

July 23, 2008 -- 73 FR 42683
In the 1989 NTP cancer studies with rats and mice, male and female reproductive organs (prostate, testes, epididymis, ovaries, uterus) were examined and no changes attributable to DDVP were found. (TR-342) 62-73-7
Final Rule Control of Emissions of Air Pollution from Locomotive Engines and Marine Compression-Ignition Engines Less than 30 Liters per Cylinder; Republication EPA is adopting a comprehensive program to dramatically reduce pollution from locomotives and marine diesel engines. The controls will apply to all types of locomotives, including line-haul, switch, and passenger, and all types of marine diesel engines below 30 liters per cylinder displacement, including commercial and recreational, propulsion and auxiliary. The near-term emission standards for newly-built engines will phase in starting in 2009. The near-term program also includes new emission limits for existing locomotives and marine diesel engines that apply when they are remanufactured, and take effect as soon as certified remanufacture systems are available, as early as 2008. The long-term emissions standards for newly-built locomotives and marine diesel engines are based on the application of high-efficiency catalytic after-treatment technology. These standards begin to take effect in 2015 for locomotives and in 2014 for marine diesel engines. We estimate particulate matter (PM) reductions of 90 percent and nitrogen oxides (NOX) reductions of 80 percent from engines meeting these standards, compared to engines meeting the current standards.

June 30, 2008 -- 73 FR 37096
The National Toxicology Program listed naphthalene as "reasonably anticipated to be a human carcinogen" in 2004 on the basis of bioassays reporting clear evidence of carcinogenicity in rats and some evidence of carcinogenicity in mice. (ROC) 

The IARC has determined that benzene is a human carcinogen and the U.S. DHHS has characterized benzene as a known human carcinogen. (ROC)

The IARC has determined that 1,3-butadiene is a human carcinogen and the U.S. DHHS has characterized 1,3-butadiene as a known human carcinogen. (ROC)

Acetaldehyde is reasonably anticipated to be a human carcinogen by the U.S. Department of Health and Human Services (DHHS) in the 11th Report on Carcinogens and is classified as possibly carcinogenic to humans (Group 2B) by the International Agency for Research on Carcinogens (IARC). (ROC)

91-20-3
71-43-2
106-99-0
75-07-0
Notice Sixty-Second Report of the TSCA Interagency Testing Committee to the Administrator of the Environmental Protection Agency; Receipt of Report and Request for Comments The Toxic Substances Control Act (TSCA) Interagency Testing Committee (ITC) transmitted its sixty-second report to the Administrator of EPA on April 17, 2008. In the 62nd ITC Report, which is included with this notice, the ITC is revising the TSCA section 4(e) Priority Testing List by removing four tungsten compounds and four cresols.

May 12, 2008 -- 73 FR 27450
The ITC is removing tungsten oxide (WO3), a.k.a. tungsten trioxide because of the voluntary information provided by the International Tungsten Industry Association and their cooperation in a National Toxicology Program/National Institute for Occupational Safety and Health research program to address exposure and toxicity data needs. The ITC is retaining tungstate (WO42-), disodium, dihydrate, (T-4)-, a.k.a. sodium tungstate (Na2 (WO4)), dihydrate (CAS No. 10213-10-2), on the Priority Testing List because of ongoing discussions with the International Tungsten Industry Association. 1314-35-8
10213-10-2