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Regulatory Actions for Year 2005

Year Agency Title CASRN
2005 EPA
National Perchloroethylene Air Emission Standards for Dry Cleaning Facilities

EPA is proposing revised standards to limit emissions of perchloroethylene (PCE) from existing and new dry cleaning facilities.

NTP Information Cited
NTP technical report on the toxicology and carcinogenesis of tetrachloroethylene (perchloroethylene) (CAS No. 127-18-4) in F344/N rats and B6C3F1 mice (inhalation studies) National Toxicology Program, Research Triangle Park, NC. (TR-311), NIH Publication No. 86-2567. August 1986.

  • Type: Proposed
  • December 21, 2005
  • 70 FR 75884
127-18-4
2005 EPA
List of Hazardous Air Pollutants, Petition Process, Lesser Quantity Designations, Source Category List

EPA is amending the list of hazardous air pollutants contained in section 112 of the Clean Air Act by removing the compound methyl ethyl ketone (MEK) (2-Butanone) (CAS No. 78-93-3). This action is being taken in response to a petition submitted by the Ketones Panel of the American Chemistry Council (formerly the Chemical Manufacturers Association) on behalf of MEK producers and consumers to delete MEK from the HAP list. Petitions to remove a substance from the HAP list are permitted under section 112 of the CAA.

NTP Information Cited
There is an absence of positive results in the majority of mutagenicity and genotoxicity tests which are designed to indicate the potential for carcinogenicity. Methyl ethyl ketone has been tested for activity in an extensive spectrum of in vitro and in vivo genotoxicity assays and has shown no evidence of genotoxicity in most conventional assays (National Toxicology Program, no date; World Health Organization 1992; Zeiger et al., 1992).

While developing the final rule, EPA learned that preliminary results of a recent cancer bioassay by the National Toxicology Program suggested that methyl isobutyl ketone (MIBK) appears to be a weak or marginally active carcinogen in rats and mice, possibly by a nongenotoxic mode of action. (TR-538)

  • Type: Final Rule
  • December 19, 2005
  • 70 FR 75047
78-93-3
108-10-1
2005 FDA
Food Additives Permitted for Direct Addition to Food for Human Consumption; Synthetic Fatty Alcohols

The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of n-octanol (n-octyl alcohol) produced by a new manufacturing process, the hydrodimerization of 1,3-butadiene. This action is in response to a petition filed by Kuraray International Corp.

NTP Information Cited
The following references have been placed on display in the Division of Dockets Management (see ADDRESSES) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. "Toxicology and Carcinogenesis Studies of 1,3-Butadiene (CAS No. 106-99-0) in B6C3F1 Mice (Inhalation Studies)," National Toxicology Program. (TR-434)

  • Type: Final Rule
  • December 08, 2005
  • 70 FR 72906
106-99-0
2005 OEHHA
Chemicals Listed Effective December 2, 2005 as Known to the State of California to Cause Reproductive Toxicity: butyl benzyl phthalate (BBP) (CAS No. 85 68-7), di-n-butyl phthalate (DBP) (CAS No. 84-74-2), and di-n-hexyl phthalate (DnHP) (CAS No. 84-75-3)

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding butyl benzyl phthalate (BBP) (CAS No. 85 68-7), di-n-butyl phthalate (DBP) (CAS No. 84-74-2), and di-n-hexyl phthalate (DnHP) (CAS No. 84-75-3) to the list of chemicals known to the state to cause reproductive toxicity 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 the three phthalates is effective December 2, 2005 Toxicological endpoint: cancer. Toxicological endpoints: Developmental toxicity, Female reproductive toxicity, and Male reproductive toxicity

NTP Information Cited
National Toxicology Program. Center for the Evaluation of Risks to Human Reproduction (NTP-CERHR, 2003b). NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Di-n-Butyl Phthalate (DBP). NIH Publication No. 03-4486.

  • Type: Notice
  • December 02, 2005
  • Proposition 65
84-74-2
2005 OEHHA
Chemicals Listed Effective December 2, 2005 as Known to the State of California to Cause Reproductive Toxicity: butyl benzyl phthalate (BBP) (CAS No. 85 68-7), di-n-butyl phthalate (DBP) (CAS No. 84-74-2), and di-n-hexyl phthalate (DnHP) (CAS No. 84-75-3)

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding butyl benzyl phthalate (BBP) (CAS No. 85 68-7), di-n-butyl phthalate (DBP) (CAS No. 84-74-2), and di-n-hexyl phthalate (DnHP) (CAS No. 84-75-3) to the list of chemicals known to the state to cause reproductive toxicity 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 the three phthalates is effective December 2, 2005 Toxicological endpoint: cancer. Toxicological endpoints: female reproductive toxicity and male reproductive toxicity

NTP Information Cited
National Toxicology Program. Center for the Evaluation of Risks to Human Reproduction (NTP-CERHR, 2003c). NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Di-n-Hexyl Phthalate (DnHP). NIH Publication No. 03-4489.

  • Type: Notice
  • December 02, 2005
  • Proposition 65
84-75-3
2005 OEHHA
Chemicals Listed Effective December 2, 2005 as Known to the State of California to Cause Reproductive Toxicity: butyl benzyl phthalate (BBP) (CAS No. 85 68-7), di-n-butyl phthalate (DBP) (CAS No. 84-74-2), and di-n-hexyl phthalate (DnHP) (CAS No. 84-75-3)

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding butyl benzyl phthalate (BBP) (CAS No. 85 68-7), di-n-butyl phthalate (DBP) (CAS No. 84-74-2), and di-n-hexyl phthalate (DnHP) (CAS No. 84-75-3) to the list of chemicals known to the state to cause reproductive toxicity 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 the three phthalates is effective December 2, 2005 Toxicological endpoint: cancer. Toxicological endpoints: Developmental toxicity

NTP Information Cited
National Toxicology Program. Center for the Evaluation of Risks to Human Reproduction (NTP-CERHR, 2003a). NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Butyl Benzyl Phthalate (BBP). NIH Publication No. 03-4487.

  • Type: Notice
  • December 02, 2005
  • Proposition 65
85-68-7
2005 OEHHA
Chemicals Listed Effective August 19, 2005 as Known to the State of California to Cause Cancer: estrogens, steroidal

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding estrogens, steroidal 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, Proposition 65). The listing of estrogens, steroidal is effective August 19, 2005.

NTP Information Cited
National Toxicology Program (NTP, 2002). Report on Carcinogens, Tenth Edition. Carcinogen Profiles. U.S. Department of Health and Human Services, Public Health Service. National Institute of Environmental Health Sciences, Research Triangle Park, NC.

  • Type: Notice
  • August 19, 2005
  • Proposition 65
Steroidal Estrogens (as a class)
2005 MSHA
Asbestos Exposure Limit

MSHA is proposing to revise their existing health standards for asbestos exposure at metal and nonmetal mines, surface coal mines, and surface areas of underground coal mines. The proposed rule would reduce the full-shift permissible exposure limit and the excursion limit for airborne asbestos fibers, and make several nonsubstantive changes to add clarity to the standard. Exposure to asbestos has been associated with lung and other cancers, mesotheliomas, and asbestosis. This proposed rule would help assure that fewer miners who work in an environment where asbestos is present would suffer material impairment of health or functional capacity over their working lifetime.

NTP Information Cited
There have been increasing numbers of studies on asbestos and its hazards over the past 40 years. These efforts encompass government, industry, and academia on a local, national, and international scale. Government agencies and scientific groups in the United States, such as the National Institute for Occupational Safety and Health (NIOSH), the Agency for Toxic Substances and Disease Registry (ATSDR), the American Conference of Governmental Industrial Hygienists (ACGIH), and the National Toxicology Program (NTP), have addressed issues involving carcinogens, such as asbestos.

  • Type: Proposed
  • July 29, 2005
  • 70 FR 43950
1332-21-4
2005 MSHA
Diesel Particulate Matter Exposure of Underground Metal and Nonmetal Miners

In this final rule: MSHA revises the existing standards addressing diesel particulate matter (DPM) exposure in underground metal and nonmetal (M/NM) mines; changes the interim concentration limit measured by total carbon to a comparable permissible exposure limit measured by elemental carbon, which renders a more accurate DPM exposure measurement; increases flexibility of compliance for mine operators by requiring longstanding hierarchy of controls for its other exposure-based health standards at M/NM mines, but retains the prohibition on rotation of miners for compliance; requires MSHA to consider economic as well as technological feasibility in determining if operators qualify for an extension of time in which to meet the final DPM limit; deletes the requirement for a control plan; and makes conforming changes to existing provisions concerning compliance determinations, environmental monitoring and recordkeeping.

NTP Information Cited
Moyer, et al. review of NTP data from 90-day and 2-yr exposures of particulates and use of mouse inhalation model and the NTP 10th edition of the Report on Carcinogens are cited in the MSHA revision of existing standards addressing diesel particulate matter (DPM) exposure in underground metal and nonmetal (M/NM) mines. (ROC)

  • Type: Final Rule
  • June 06, 2005
  • 70 FR 32868
2005 OEHHA
Chemicals Listed Effective May 27, 2005 and May 31, 2005 as known to the State of California to Cause Cancer or Reproductive Toxicity

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding 2-bromopropane (2-BP) (CAS No. 75-26-3)...to the list of chemicals known to the state to cause cancer or reproductive toxicity for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Health and Safety Code section 25249.5, Proposition 65). The listing of... 2-bromopropane (2-BP) is effective May 31, 2005. Toxicological endpoint: Female reproductive and male reproductive toxicity

NTP Information Cited
National Toxicology Program - Center for the Evaluation of Risks to Human Reproduction (NTP-CERHR, 2003). NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of 2-Bromopropane . NIH Publication No. 04-4480. U.S. Department of Health and Human Services, Public Health Service, National Institutes of Health, NTP, Research Triangle Park, NC.

  • Type: Notice
  • May 31, 2005
  • Proposition 65
75-26-3
2005 OEHHA
Chemicals Listed Effective May 20, 2005 as Known to the State of California to Cause Cancer: Cobalt sulfate, Diazoaminobenzene

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding cobalt sulfate (CAS No. 10124-43-3) and diazoaminobenzene (CAS No. 136-35-6) 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, Proposition 65). The listing of cobalt sulfate and diazoaminobenzene is effective May 20, 2005. Toxicological Endpoint: cancer

NTP Information Cited
National Toxicology Program (NTP, 2004). Report on Carcinogens, Eleventh Edition. Carcinogen Profiles. U.S. Department of Health and Human Services, Public Health Service. National Institute of Environmental Health Sciences, Research Triangle Park, NC.

  • Type: Notice
  • May 20, 2005
  • Proposition 65
10124-43-3
2005 OEHHA
Chemicals Listed Effective May 20, 2005 as Known to the State of California to Cause Cancer: Cobalt sulfate, Diazoaminobenzene

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding cobalt sulfate (CAS No. 10124-43-3) and diazoaminobenzene (CAS No. 136-35-6) 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, Proposition 65). The listing of cobalt sulfate and diazoaminobenzene is effective May 20, 2005. Toxicological Endpoint: cancer

NTP Information Cited
NTP concluded that diazoaminobenzene (DAAB) is reasonably anticipated to be a human carcinogen based on evidence from studies in animals and with human tissue demonstrating that DAAB is metabolized to benzene, a known human carcinogen, and on evidence that DAAB causes genetic damage. 

National Toxicology Program (NTP, 2004). Report on Carcinogens, Eleventh Edition. Carcinogen Profiles. U.S. Department of Health and Human Services, Public Health Service. National Institute of Environmental Health Sciences, Research Triangle Park, NC.

  • Type: Notice
  • May 20, 2005
  • Proposition 65
136-35-6
2005 EPA
Pinene Polymers; Exemption from the Requirement of a Tolerance

This regulation establishes exemptions from the requirement of a tolerance for residues of several alpha and/or beta-pinene polymers when used as inert ingredients in or on growing crops and when applied to raw agricultural commodities after harvest. Hercules, Inc. 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 alpha and/or beta-pinene polymers.

NTP Information Cited
The data considered in this assessment included information submitted by the petitioner, and information located by OPP on the internet, primarily information prepared by the National Toxicology Program (NTP) and the robust summaries for bicyclic terpene hydrocarbons submitted in 2002 to EPA by the Terpene Consortium of the Flavor and Fragrance High Production Volume Consortia (FFHPVC).

  • Type: Final Rule
  • May 18, 2005
  • 70 FR 28447
2005 EPA
Isophorone; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food

This notice announces the initial filing of a pesticide petition proposing the establishment of regulations for residues of a certain pesticide chemical in or on various food commodities.

NTP Information Cited
In an oral gavage chronic toxicity/oncogenicity study conducted by the National Toxicology Program at dose levels of 0, 250 and 500 mg/kg/day in F344 rats and B6C3F1 mice, there was some evidence of carcinogenicity of isophorone in male rats (kidney tumors, preputial gland carcinomas). (TR-291)

  • Type: Notice
  • April 27, 2005
  • 70 FR 21767
78-59-1
2005 OSHA
Notice of Availability of the Regulatory Flexibility Act Review of the Occupational Health Standard for Ethylene Oxide

The Occupational Safety and Health Administration (OSHA) has conducted a review of its Ethylene Oxide (EtO) Standard pursuant to section 610 of the Regulatory Flexibility Act and section 5 of Executive Order 12866 on Regulatory Planning and Review.

NTP Information Cited
There is a continued need for the rule. Workers exposed to EtO in a range of industries would continue to be at risk of cancer, genetic changes and other adverse health effects, without the standard. Since the standard was developed, the International Agency for Research on Cancer reclassified EtO as a known human carcinogen and the National Toxicology program reclassified EtO as a one "known to be a human carcinogen." (TR-326)(ROC)

  • Type: Notice
  • April 22, 2005
  • 70 FR 20807
75-21-8
2005 FDA
Food Additives Permitted for Direct Addition to Food for Human Consumption; Acacia (Gum Arabic)

The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of acacia (gum arabic) as a thickener, emulsifier, or stabilizer in alcoholic beverages at a maximum use level of 20 percent. This action is in response to a petition filed by Kerry, Inc.

NTP Information Cited
FDA conducted literature searches that updated the information that had formed the basis of the Select Committee report. The agency reviewed toxicological data from a 1982 National Toxicology Program (NTP) report of 2-year carcinogenicity feeding studies on acacia in F344 rats and B6C3F1 mice. The agency evaluated the carcinogenicity of acacia and concluded that F344 rats and B6C3F1 mice consuming diets containing up to 5-percent acacia for 2 years showed no increased incidences of tumors at any site. (TR-227)

  • Type: Final Rule
  • February 17, 2005
  • 70 FR 8032
9000-01-5
2005 OEHHA
Chemical Listed Effective February 11, 2005 as Known to the State of California to Cause Cancer: Vanadium Pentoxide

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding vanadium pentoxide (orthorhombic crystalline form) 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., Proposition 65). The listing of the chemical is effective February 11, 2005. Toxicological Endpoint: Cancer

NTP Information Cited
National Toxicology Program (NTP, 2002). Toxicology and Carcinogensis Studies of Vanadium Pentoxide (CAS No. 1314-62-1) in F344/N Rats and B6C3F1 Mice (Inhalation). NTP Technical Report Series No. 507. NIH Publication No. 03-4441. U.S. Department of Health and Human Services, Public Health Service, National Institutes of Health, NTP, Research Triangle Park, NC.

  • Type: Notice
  • February 11, 2005
  • Proposition 65
1314-63-1
2005 CPSC
Standard for the Flammability (Open Flame) of Mattresses and Mattress/Foundation Sets; Notice of Proposed Rulemaking

The Commission is proposing a flammability standard under the authority of the Flammable Fabrics Act that would address open flame ignition of mattresses and mattress and foundation sets ("mattresses/sets").

NTP Information Cited
Additional activities by EPA, The National Toxicology Program (NTP) of the Department of Health and Human Services (DHHS), and the Occupational Safety and Health Administration (OSHA) can provide information about any adverse health effects of FR chemicals and take actions to limit their use if necessary.

  • Type: Proposed
  • January 13, 2005
  • 70 FR 2470
2005 FDA
Guidance for Industry: Labeling for Topically Applied Cosmetic Products Containing Alpha Hydroxy Acids as Ingredients; Availability

The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled "Guidance for Industry: Labeling for Topically Applied Cosmetic Products Containing Alpha Hydroxy Acids as Ingredients." The guidance recommends content for a labeling statement for cosmetic products containing alpha hydroxy acids (AHAs) as ingredients.

NTP Information Cited
Publication of this guidance is an interim measure while FDA continues to review the data on the effects of AHA-containing products on skin sensitivity to UV radiation, including a photocarcinogenicity study by the National Toxicology Program's Center for Phototoxicology and recent studies published in peer-reviewed journals. FDA invites comments to continue to inform FDA of new studies when they become available. (TR-524)

  • Type: Notice
  • January 10, 2005
  • 70 FR 1721
79-14-1 and 69-72-7