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Regulatory Actions for Year 2006

Year Agency Title CASRN
2006 OEHHA
Final Public Health Goal for N-Nitrosodimethylamine and Cadmium in Drinking Water

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency announces the publication of the final Public Health Goals (PHGs) for N-nitrosodimethylamine and cadmium.

NTP Information Cited
NTP (2000). 9th Report on Carcinogens.

  • Type: Notice
  • December 22, 2006
  • Proposition 65
2006 OEHHA
Chemicals Delisted Effective December 8, 2006 from the List of Chemicals Known to the State of California to Cause Cancer, isosafrole, 5-nitro-o-anisidine, tris(aziridinyl)-p-benzoquinone

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is removing isosafrole [CAS No. 120-58-1], 5-nitro-o-anisidine [CAS No. 99-59-2], and tris(aziridinyl)-p-benzoquinone (triaziquone) [CAS No. 68-76-8] from the list of chemicals known to the State to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). The delisting of the three chemicals is effective December 8, 2006. 5-Nitro-o-anisidine was removed from the NTP Sixth Annual Report on Carcinogens as a substance reasonably anticipated to be a human carcinogen in 1991, when NTP concluded there was insufficient evidence of carcinogenicity.

NTP Information Cited
Report on Carcinogens, Eleventh Edition (2004); Appendix B; National Toxicology Program, U.S. Department of Health and Human Services, Research Triangle Park, NC

  • Type: Notice
  • December 08, 2006
  • Proposition 65
99-59-2
2006 EPA
Diflubenzuron; Pesticide Tolerances

This regulation establishes tolerances for combined residues of diflubenzuron and its metabolites 4-chlorophenylurea and 4-chloroaniline in or on brassica, leafy greens subgroup 5B, turnip greens, peanut, peanut hay, peanut oil, barley grain, barley hay, barley straw, oat grain, oat forage, oat hay, oat straw, wheat grain, wheat forage, wheat hay, wheat straw, aspirated grain fractions, and pummelo. The Interregional Research Project #4 requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA).

NTP Information Cited
The Agency has classified diflubenzuron as "Group E," evidence of non-carcinogenicity for humans, based on lack of evidence of carcinogenicity in rats and mice. There are also 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)

  • Type: Final Rule
  • November 29, 2006
  • 71 FR 69028
35367-38-5
150-68-5
106-47-8
2006 EPA
Export Notification; Change to Reporting Requirements

EPA is promulgating amendments to the Toxic Substances Control Act (TSCA) section 12(b) export notification regulations at subpart D of 40 CFR part 707. One amendment changes the current annual notification requirement to a one-time requirement for exporters of chemical substances or mixtures (hereinafter referred to as "chemicals") for which certain actions have been taken under TSCA. Relatedly, for the same TSCA actions, EPA is changing the current requirement that the Agency notify foreign governments annually after the Agency's receipt of export notifications from exporters to a requirement that the Agency notify foreign governments once after it receives the first export notification from an exporter. EPA is also promulgating de minimis concentration levels below which notification will not be required for the export of any chemical for which export notification under TSCA section 12(b) is otherwise required, promulgating other minor amendments (to update the EPA addresses to which export notifications must be sent, to indicate that a single export notification may refer to more than one section of TSCA where the exported chemical is the subject of multiple TSCA actions, and to correct an error in 40 CFR 799.19 that currently omits mentioning multi-chemical test rules as being among those final TSCA section 4 actions that trigger export notification), and clarifying exporters' and EPA's obligations where an export notification- triggering action is taken with respect to a chemical previously or currently subject to export notification due to the existence of a previous triggering action.

NTP Information Cited
EPA will consider the lists maintained by the World Health Organization, International Agency for Research on Cancer (IARC) and the US Department of Health and Human Services, Public Health Service, National Toxicology Program (NTP) as the definitive sources. The NTP Report on Carcinogens is mandated by section 301(b)(4) of the Public Health Service Act, as amended (42 U.S.C. 201 et seq.), which stipulates that the Secretary of the Department of Health and Human Services shall publish an annual report which contains a list of all substances: • Which either are known to be carcinogens in humans or may reasonably be anticipated to be human carcinogens • To which a significant number of persons residing in the United States are exposed. (ROC)

  • Type: Final Rule
  • November 14, 2006
  • 71 FR 66234
2006 EPA
Proposed Test Rule for Certain Chemicals on the ATSDR/EPA CERCLA Priority List of Hazardous Substances

EPA is proposing to require testing for certain chemicals on the Agency for Toxic Substances and Disease Registry (ATSDR)/EPA Priority List of Hazardous Substances which is compiled under the Comprehensive Environmental Response Compensation and Liability Act (CERCLA), and is soliciting proposals for enforceable consent agreements (ECAs). EPA is proposing a test rule under section 4(a) of the Toxic Substances Control Act (TSCA) that would require manufacturers (including importers) and processors of four chemical substances (chloroethane, hydrogen cyanide, methylene chloride, and sodium cyanide) to conduct testing for certain health effects relating to the manufacture, distribution in commerce, processing, use, or disposal of these substances.

NTP Information Cited
The toxicological profiles are developed by ATSDR in collaboration with EPA and NTP, independent peer reviewers, and the public.

  • Type: Proposed
  • October 20, 2006
  • 71 FR 61926
2006 ATSDR
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 20th set of toxicological profiles, which consists of one new draft and six updated drafts, prepared by ATSDR for review and comment.

NTP Information Cited
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 assure the initiation of research to determine these health effects.

  • Type: Notice
  • October 18, 2006
  • 71 FR 61479
2006 EPA
Request for Nominations of Drinking Water Contaminants for the Contaminant Candidate List

The Environmental Protection Agency (EPA) is requesting nominations of chemical and microbial contaminants for possible inclusion in the third drinking water Contaminant Candidate List (CCL 3). EPA is also requesting information that shows the nominated contaminant may have an adverse health effect on people and the contaminant occurs or is likely to occur.

NTP Information Cited

  • Type: Notice
  • September 16, 2006
  • 71 FR 60704
2006 EPA
Eucalyptus Oil; Exemption from the Requirement of a Tolerance

This regulation establishes an exemption from the requirement of a tolerance for residues of eucalyptus oil on honey and honeycomb when applied at 2 g or less eucalyptus oil per hive to suppress varroa mites. Brushy Mountain Bee farm, c/o IR-4 Project 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 eucalyptus oil in honey and honeycomb.

NTP Information Cited
National Toxicology Program. 1982. Salmonella assay for genetic toxicity from exposure to 1,8 cineole. Study 246429.

National Toxicology Program. 1982. CHO cell cytogenetics; chromosome aberrations and sister chromatid exchanges from exposure to 1,8 cineole. Study 590755.

  • Type: Final Rule
  • September 13, 2006
  • 71 FR 53974
470-82-6
2006 ATSDR
Identification of Priority Data Needs for Two Priority Hazardous Substances

Request for public comments on the identification of priority data needs for two priority hazardous substances, and an ongoing call for voluntary research proposals.

NTP Information Cited
A Tri-Agency Superfund Applied Research Committee (TASARC) comprised of scientists from ATSDR, the National Toxicology Program (NTP), and EPA, will review all proposals.

  • Type: Notice
  • September 08, 2006
  • 71 FR 53102
2006 FDA
Skin Bleaching Drug Products For Over-the-Counter Human Use; Proposed Rule

The Food and Drug Administration is issuing a notice of proposed rulemaking that would establish that over-the-counter (OTC) skin bleaching drug products are not generally recognized as safe and effective (GRASE) and are misbranded. FDA is also withdrawing the previous proposed rule on skin bleaching drug products for OTC human use, which was issued in the form of a tentative final monograph (TFM). FDA is issuing this proposed rule after considering new data and information on the safety of hydroquinone, the only active ingredient that had been proposed for inclusion in a monograph for these products. This proposal is part of FDA's ongoing review of OTC drug products. Further, upon issuance of a final rule, FDA intends to consider all skin bleaching drug products, whether currently marketed on a prescription or OTC basis, to be new drugs requiring an approved new drug application (NDA) for continued marketing.

NTP Information Cited
Toxicology and carcinogenesis studies on orally administered hydroquinone conducted under the support of the National Toxicology Program (NTP) (Refs. 1 and 2) have indicated "some evidence" of carcinogenicity in male and female rats and in female mice. FDA's Center for Drug Evaluation and Research (CDER) Carcinogenicity Assessment Committee (CAC) has evaluated the design, results, and NTP interpretation of these studies, and concurs with the NTP's assessment. (TR-366)

  • Type: Proposed
  • August 29, 2006
  • 71 FR 51146
123-31-9 and 497-76-7
2006 MSHA
Diesel Particulate Matter Exposure of Underground Metal and Nonmetal Miners

This final rule revises the May 20, 2006 effective date of the diesel particulate matter (DPM) final concentration limit of 160 micrograms of total carbon (TC) per cubic meter of air (160TC ug/m3) promulgated in the 2001 final rule "Diesel Particulate Matter Exposure of Underground Metal and Nonmetal Miners," and published in the Federal Register on January 19, 2001 (66 FR 5706) and amended on September 19, 2005 (70 FR 55019).

NTP Information Cited
In the 10th edition of its Report on Carcinogens, the National Toxicology Program (NTP) of the National Institutes of Health formally retained its designation of diesel exhaust particulates as "reasonably anticipated to be a human carcinogen." (U.S. Dept. of Health and Human Services, 2002). (ROC)

Although many commenters agreed that the adverse health effects associated with miners' exposure to DPM warranted an exposure limit, commenters from trade associations and industry continued to challenge the conclusions of the 2001 risk assessment. Discussions addressing this issue were summarized in the 2001 risk assessment and the 2005 update. As referenced in this section, the U.S. Environmental Protection Agency, World Health Organization, and the National Toxicology Program regard DPM exposure as adversely affecting human health.

  • Type: Final Rule
  • May 18, 2006
  • 71 FR 28924
2006 EPA
Ethylene Oxide Emissions Standards for Sterilization Facilities

This action finalizes our decision not to revise the Ethylene Oxide Emission Standards for Sterilization Facilities, originally promulgated on December 6, 1994. Within 8 years of promulgating these standards, the Clean Air Act directs us to assess the risk and to promulgate more stringent standards if necessary to protect public health with an ample margin of safety and to prevent adverse environmental effects. Also, within 8 years of promulgating the national emission standards, the Clean Air Act requires us to review and revise the standards as necessary, taking into account developments in practices, processes, and control technologies. Today¿s action reflects our findings that after conducting these risk and technology reviews, no additional control requirements are warranted.

NTP Information Cited
In 1994, the International Agency for Research on Cancer categorized ethylene oxide in their Group 1 (Carcinogenic to Humans). In 2000, the United States Department of Health and Human Services revised its listing for ethylene oxide to "known to be a human carcinogen" in the Ninth Report on Carcinogens.

DHHS. 2000. Report on Carcinogens, Eleventh Edition; United States Department of Health and Human Services, Public Health Service, National Toxicology Program.
(ROC)

  • Type: Final Rule
  • April 07, 2006
  • 71 FR 17712
2006 EPA
Testing of Certain High Production Volume Chemicals

EPA is promulgating a final rule under the Toxic Substances Control Act that requires manufacturers (including importers) and processors of 17 high production volume chemicals to conduct acute toxicity, repeat dose toxicity, developmental and reproductive toxicity, genetic toxicity (gene mutations and chromosomal aberrations), ecotoxicity (in fish, Daphnia, and algae), and environmental fate (including 5 tests for physical chemical properties and biodegradation) testing.

NTP Information Cited
With one exception, the "Class 1" chemical substances listed in Table 2 in § 799.5085(j) of the regulatory text (i.e., 12 of the 17 chemical substances included in this final rule) must be tested at a purity of at least 99%. The exception is 1,3-propanediol, 2,2-bis[(nitrooxy)methyl]-,dinitrate (ester) also known as pentaerythritol tetranitrate (PETN), which cannot be tested at 99% purity because of its explosive properties and must either be diluted in water or tested in a mixture with an appropriate stabilizing compound (e.g., D-lactose monohydrate is the stabilizer in PETN, NF which is a mixture that is 20% by weight PETN and 80% by weight Dlactose monohydrate). PETN, NF is the form of PETN which was tested by NTP in several toxicity studies.

U.S. Department of Health and Human Services. National Institutes of Health. NTP. Toxicology and carcinogenesis studies of pentaerythritol tetranitrate in F344/N rats and B6C3F1 mice (feed studies). (TR-365)

  • Type: Final Rule
  • March 16, 2006
  • 71 FR 13708
78-11-5
2006 EPA
Ethylenediaminetetraacetic Acid Chemicals: Exemptions from the Requirement of a Tolerance

The Agency is proposing to establish 16 new and amend three existing exemptions from the requirement of a tolerance for residues of various ethylenediaminetetraacetic acid (EDTA) chemicals in or on raw agricultural commodities when used as inert ingredients in pesticide formulations applied to growing crops or to raw agricultural commodities after harvest under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA). This regulation eliminates the need to establish a maximum permissible level for residues of these EDTA chemicals.

NTP Information Cited
The toxicological profile data considered in this assessment included information located by the Office of Pesticide Programs on the internet, studies conducted by the National Toxicology Program (NTP) and the National Cancer Institute (NCI), several work products produced by the Cosmetic Ingredient Review, several evaluations by the World Health Organization, and articles from open literature.

Based on the available toxicity data on ethylenediaminetetraacetic acid (EDTA) and its various salts, with particular emphasis on the comparison of the findings in the two developmental toxicity studies; the reviews and evaluations conducted by NTP, NCI, and WHO; the knowledge that trace metal supplementation occurs via the food and drinking water consumed by human beings; and considering the estimated exposures of the wide-spread existing uses of ethylenediaminetetraacetic acid (EDTA) and its various salts which are less than levels at which adverse effects were noted, EPA concludes that there is a reasonable certainty of no harm from aggregate exposure to residues of ethylenediaminetetraacetic acid (EDTA) and its various salts. (TR-11)

  • Type: Proposed
  • March 08, 2006
  • 71 FR 11563
150-38-9
2006 OEHHA
Announcement of Publication of the Final Technical Support Documents for the Public Health Goal and Responses to Comments for Six Chemicals in Drinking Water

In accordance with Health and Safety Code Section 116293 (SB1822, Sher, Statutes of 2002), the Office of Environmental Health Hazard Assessment (OEHHA) hereby publishes the final Public Health Goal (PHG) for cis/trans-1,2-dichloroethylene, 1,1,1-trichloroethane, 1,1,2-trichloroethane, radium-226 and 228, strontium-90, and tritium in drinking water. OEHHA has completed technical support documents that provide the scientific basis for the PHGs.

NTP Information Cited
NTP (2002). Toxicity Studies of trans-1,2-Dichloroethylene (CAS No. 156-60-5) Administered in Microcapsules in Feed to F344/N Rats and B6C3F1 Mice. TOX-55.

  • Type: Notice
  • March 06, 2006
  • Proposition 65
156-60-5
2006 OEHHA
Announcement of Publication of the Final Technical Support Documents for the Public Health Goal and Responses to Comments for Six Chemicals in Drinking Water

In accordance with Health and Safety Code Section 116293 (SB1822, Sher, Statutes of 2002), the Office of Environmental Health Hazard Assessment (OEHHA) hereby publishes the final Public Health Goal (PHG) for cis/trans-1,2-dichloroethylene, 1,1,1-trichloroethane, 1,1,2-trichloroethane, radium-226 and 228, strontium-90, and tritium in drinking water. OEHHA has completed technical support documents that provide the scientific basis for the PHGs.

NTP Information Cited
NTP (1988). Developmental toxicity evaluation of 1,1,1-trichloroethane (CAS No. 7l-55-6) administered to CD rats. Final report part 2. TO151 and TO179.

NTP (1996). Technical report on renal toxicity studies of selected halogenated ethanes administered by gavage to F344/N rats. Toxicity Report Series. TOX-45

NTP (2000). Technical report on the toxicity studies of 1,1,1-trichloroethane (CAS No. 71-55-6) administered in microcapsules in feed to F344/N rats and B6C3F1 mice. TOX-41

  • Type: Notice
  • March 06, 2006
  • Proposition 65
71-55-6
2006 OSHA
Occupational Exposure to Hexavalent Chromium

The Occupational Safety and Health Administration (OSHA) is amending the existing standard which limits occupational exposure to hexavalent chromium (Cr(VI)). OSHA has determined based upon the best evidence currently available that at the current permissible exposure limit (PEL) for Cr(VI), workers face a significant risk to material impairment of their health.

NTP Information Cited
The National Toxicology Program (NTP) conducted an extensive multigenerational reproductive assessment by continuous breeding where the chromate was administered in the diet. The assessment yielded negative results. Animal inhalation studies were also negative. Thus, it cannot be concluded that Cr(VI) is a reproductive toxin for normal working situations. (Hexavalent chromium)

  • Type: Final Rule
  • February 28, 2006
  • 71 FR 10100
18540-29-9
2006 EPA
National Primary Drinking Water Regulations: Stage 2 Disinfectants and Disinfection Byproducts Rule

The Environmental Protection Agency (EPA) is promulgating today's final rule, the Stage 2 Disinfectants and Disinfection Byproducts Rule (DBPR), to provide for increased protection against the potential risks for cancer and reproductive and developmental health effects associated with disinfection byproducts (DBPs).

NTP Information Cited
Two-year bioassays by the National Toxicology Program (NTP) released in abstract form have recently been completed on BDCM and chlorate. The draft abstract on BDCM reported no evidence of carcinogenicity when BDCM was administered via drinking water (NTP 2005a). Another recent study, a modified two-year bioassay on BDCM in the drinking water, reported little evidence of carcinogenicity (George et al. 2002). In a previous NTP study, tumors were observed, including an increased incidence of kidney, liver, and colon tumors, when BDCM was administered at higher doses by gavage in corn oil (NTP 1987). EPA will examine new information on BDCM as it becomes available. In the chlorate draft abstract, NTP found some evidence that it may be a carcinogen (NTP 2004). Chlorate is a byproduct of hypochlorite and chlorine dioxide systems. A long-term, two-year bioassay NTP study on DBA is also complete but has not yet undergone peer review (NTP 2005b). (TR-321) (TR-532) (GMM-5) (TR-517) (TR-537)

  • Type: Final Rule
  • January 04, 2006
  • 71 FR 388
75-27-4
7775-09-9
and 631-64-1