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Regulatory Actions for Year 2012

Year Agency Title CASRN
2012 EPA
2017 and Later Model Year Light-Duty Vehicle Greenhouse Gas Emissions and Corporate Average Fuel Economy Standards

EPA and NHTSA, on behalf of the Department of Transportation, are issuing final rules to further reduce greenhouse gas emissions and improve fuel economy for light-duty vehicles for model years 2017 and beyond. On May 21, 2010, President Obama issued a Presidential Memorandum requesting that NHTSA and EPA develop through notice and comment rulemaking a coordinated National Program to improve fuel economy and reduce greenhouse gas emissions of light-duty vehicles for model years 2017-2025, building on the success of the first phase of the National Program for these vehicles for model years 2012-2016. This final rule, consistent with the President's request, responds to the country's critical need to address global climate change and to reduce oil consumption. NHTSA is finalizing Corporate Average Fuel Economy standards for model years 2017-2021 and issuing augural standards for model years 2022-2025 under the Energy Policy and Conservation Act, as amended by the Energy Independence and Security Act. NHTSA will set final standards for model years 2022-2025 in a future rulemaking. EPA is finalizing greenhouse gas emissions standards for model years 2017-2025 under the Clean Air Act. These standards apply to passenger cars, light-duty trucks, and medium-duty passenger vehicles, and represent the continuation of a harmonized and consistent National Program. Under the National Program automobile manufacturers will be able to continue building a single light-duty national fleet that satisfies all requirements under both programs while ensuring that consumers still have a full range of vehicle choices that are available today. EPA is also finalizing minor changes to the regulations applicable to model years 2012-2016, with respect to air conditioner performance, nitrous oxides measurement, off-cycle technology credits, and police and emergency vehicles.

NTP Information Cited
National Toxicology Program Report on Carcinogens (ROC): acetaldehyde and naphthalene are reasonably anticipated to be human carcinogens; benzene, 1,3-butadiene and formaldehyde are known human carcinogens.

  • Type: Final Rule
  • October 15, 2012
  • 77 FR 62624
75-07-0
91-20-3
71-43-2
106-99-0
50-00-0
2012 CDC
World Trade Center Health Program; Addition of Certain Types of Cancer to the List of WTC-Related Health Conditions

Title I of the James Zadroga 9/11 Health and Compensation Act of 2010 amended the Public Health Service Act (PHS Act) to establish the World Trade Center (WTC) Health Program. The WTC Health Program, which is administered by the Director of the National Institute for Occupational Safety and Health (NIOSH), within the Centers for Disease Control and Prevention (CDC), provides medical monitoring and treatment to eligible firefighters and related personnel, law enforcement officers, and rescue, recovery, and cleanup workers who responded to the September 11, 2001, terrorist attacks in New York City, at the Pentagon, and in Shanksville, Pennsylvania, and to eligible survivors of the New York City attacks. In accordance with WTC Health Program regulations, which establish procedures for adding a new condition to the list of covered health conditions, this final rule adds to the List of WTC-Related Health Conditions the types of cancer proposed for inclusion by the notice of proposed rulemaking.

NTP Information Cited
Five main sources, including the National Toxicology Program, were used to evaluate whether to add cancers to the WTC-Related Health Conditions list. One of several methods used to identify cancers employed the list of known human carcinogens and those agents reasonably anticipated to be carcinogenic in humans (ROC).

  • Type: Final Rule
  • September 12, 2012
  • 77 FR 567138
NA
2012 OEHHA
Added to List of Chemicals Known to the State to Cause Cancer: Isopyrazam and 3,3',4,4'-Tetrachloroazobenzene

Effective July 24, 2012, the Office of Environmental Health Hazard Assessment (OEHHA) is adding two chemicals, isopyrazam (CAS No. 881685-58-1) and 3,3’,4,4’‑tetrachloroazobenzene (CAS No. 14047-09-7), 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 (commonly known as Proposition 651)

NTP Information Cited
NTP (2010). National Toxicology Program. Toxicology and Carcinogenesis Studies of 3,3',4,4'-Tetrachloroazobenzene (TCAB) (CAS No. 14047-09-7) in Harlan Sprague-Dawley Rats and B6C3F1 Mice (Gavage Studies).  Technical Report Series No. 558. NIH Publication No. 11-5899. U.S. Department of Health and Human Services, NTP, Research Triangle Park, NC.

  • Type: Notice
  • July 24, 2012
  • Proposition 65
14047-09-7
2012 CPSC
Proposed Statement of Policy on Animal Testing

The Consumer Product Safety Commission (CPSC or Commission) proposes to codify its statement of policy on animal testing, as amended, which was previously published in the Federal Register. The amended statement of policy on animal testing is intended for manufacturers of products subject to the Federal Hazardous Substances Act (FHSA) to find alternatives to animal testing and reduce the number of animal tests under the FHSA.

NTP Information Cited
According to the ICCVAM Authorization Act, ICCVAM member agencies should promote and encourage the development and use of alternatives to animal test methods for regulatory purposes. Since the establishment of ICCVAM, the CPSC has approved, where applicable, recommendations made by ICCVAM to reduce and refine animal testing applicable to test methods under the FHSA. The CPSC is amending and updating regulations under the FHSA to make the ICCVAM recommendations and the CPSC animal testing policy more accessible and transparent to interested parties. CPSC will also create a page on its website regarding ICCVAM recommendations and new developments in test methods that further reduce or refine animal testing. (ICCVAM)

  • Type: Proposed
  • June 29, 2012
  • 77 FR 38751
NA
2012 CDC
World Trade Center Health Program; Addition of Certain Types of Cancer to the List of WTC-Related Health Conditions

Title I of the James Zadroga 9/11 Health and Compensation Act of 2010 amended the Public Health Service Act (PHS Act) to establish the World Trade Center (WTC) Health Program. The WTC Health Program, which is administered by the Director of the National Institute for Occupational Safety and Health (NIOSH), within the Centers for Disease Control and Prevention (CDC), provides medical monitoring and treatment to eligible firefighters and related personnel, law enforcement officers, and rescue, recovery, and cleanup workers who responded to the September 11, 2001, terrorist attacks in New York City, at the Pentagon, and in Shanksville, Pennsylvania, and to eligible survivors of the New York City attacks. In accordance with our regulations, which establish procedures for adding a new condition to the list of health conditions covered by the WTC Health Program, this proposed rule would add certain types of cancer to the List of WTC-Related Health Conditions.

NTP Information Cited
NTP’s Report on Carcinogens states arsenic and vinyl chloride as known carcinogens (ROC).

  • Type: Notice
  • June 13, 2012
  • 77 FR 35574
7740-38-2
75-01-4
2012 EPA
Sixty-Ninth 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 69th Report to the EPA Administrator on April 5, 2012. In the 69th ITC Report, which is included with this notice, the ITC is adding a category of cadmium compounds including any chemical that contains cadmium as part of that chemical's structure, 6 non-phthalate plasticizers, 25 phosphate ester flame retardants, 2 other flame retardants, 9 chemicals to which children living near hazardous waste sites may be exposed, and a category of 69 diisocyanates and related compounds (including 14 Action Plan chemicals and 55 related compounds) to the TSCA Priority Testing List. In addition, the ITC is removing 103 cadmium compounds and 14 High Production Volume (HPV) Challenge Program orphan chemicals from the Priority Testing List during this reporting period (June to November 2011). The ITC is adding the category of cadmium compounds and removing 103 cadmium compounds to provide a more comprehensive approach to assessing cadmium compounds' safety.

NTP Information Cited
NTP is testing (tris(chloropropyl)phosphate) (mixture of isomers).

  • Type: Notice
  • May 23, 2012
  • 77 FR 30856
13674-84-5
2012 EPA
Integrated Risk Information System (IRIS); Announcement of 2012 Program

The U.S. Environmental Protection Agency (EPA) is announcing the IRIS 2012 agenda and requesting scientific information on health effects that may result from exposure to the chemical substances on the agenda, including assessments that EPA is starting this year.

NTP Information Cited
(Draft Monograph on Health Effects of Low-Level Lead)

  • Type: Other
  • May 07, 2012
  • 77 FR 26751
7439-92-1
2012 FDA
Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke; Established List

The Food and Drug Administration (FDA) is establishing a list of harmful and potentially harmful constituents (HPHCs) in tobacco products and tobacco smoke (the established HPHC list) as required by the Federal Food, Drug, and Cosmetic Act (the FD&C Act).

NTP Information Cited
For establishing the list of harmful and potentially harmful constituents in tobacco products and smoke, part of the criteria used were constituents identified by the National Toxicology Program as known or probable human carcinogens.

  • Type: Notice
  • April 03, 2012
  • 77 FR 20034
N/A
2012 EPA
Benzidine-Based Chemical Substances; Di-n-pentyl phthalate (DnPP); and Alkanes, C12–13, Chloro; Proposed Significant New Use Rules

Under the Toxic Substances Control Act (TSCA), EPA is proposing: To add nine benzidine-based chemical substances to the Significant New Use Rule (SNUR) on benzidine-based chemical substances; a SNUR for di-n-pentyl phthalate (DnPP) (1,2-benzene­di­carboxylic acid, 1,2-dipentyl ester) (CAS No. 131-18-0); and a SNUR for alkanes, C12–13, chloro (CAS No. 71011-12-6). In the case of the benzidine-based chemical substances, EPA is also proposing to make inapplicable the exemption relating to persons that import or process substances as part of an article. If finalized, this rule would require persons who intend to manufacture, import, or process these chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity. The required notification would provide EPA with the opportunity to evaluate activities associated with a significant new use and an opportunity to protect against potential unreasonable risks, if any, from exposure to the chemical substance.

NTP Information Cited
Benzidine-based dyes are metabolized to its parent molecule, which is a known carcinogen (ROC). Exposure to phthalates in animal studies caused a decreased development of the reproductive system. A study of Di-n-pentyl phthalate showed a decrease in the number of litters from fertile pairs, decreased number of live pups, and decreased fertility and reproduction

  • Type: Proposed
  • March 28, 2012
  • 77 FR 18752
92-87-5
131-18-0
2012 OSHA
Hazard Communication

In this final rule, OSHA is modifying its Hazard Communication Standard (HCS) to conform to the United Nations' Globally Harmonized System of Classification and Labelling of Chemicals (GHS). OSHA has determined that the modifications will significantly reduce costs and burdens while also improving the quality and consistency of information provided to employers and employees regarding chemical hazards and associated protective measures. Consistent with the requirements of Executive Order 13563, which calls for assessment and, where appropriate, modification and improvement of existing rules, the Agency has concluded this improved information will enhance the effectiveness of the HCS in ensuring that employees are apprised of the chemical hazards to which they may be exposed, and in reducing the incidence of chemical-related occupational illnesses and injuries. The modifications to the standard include revised criteria for classification of chemical hazards; revised labeling provisions that include requirements for use of standardized signal words, pictograms, hazard statements, and precautionary statements; a specified format for safety data sheets; and related revisions to definitions of terms used in the standard, and requirements for employee training on labels and safety data sheets. OSHA is also modifying provisions of other standards, including standards for flammable and combustible liquids, process safety management, and most substance-specific health standards, to ensure consistency with the modified HCS requirements. The consequences of these modifications will be to improve safety, to facilitate global harmonization of standards, and to produce hundreds of millions of dollars in annual savings.

NTP Information Cited
Used the classification listing that NTP uses on Safety Data Sheets; based classification to determine carcinogenicity on the National Toxicology Program’s Report on Carcinogens (ROC).

  • Type: Final Rule
  • March 26, 2012
  • 77 FR 17574
NA
2012 FDA
International Conference on Harmonisation; Final Recommendation for the Revision of the Permitted Daily Exposure for the Solvent Cumene According to the Maintenance Procedures for the Guidance Q3C Impurities: Residual Solvents; Availability

The Food and Drug Administration (FDA) is announcing the availability of a final recommendation for the revision of the permitted daily exposure (PDE) for the solvent cumene according to the maintenance procedures for the guidance for industry entitled “Q3C Impurities: Residual Solvents.” The recommendation was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

NTP Information Cited
NTP Work Cited: NTP 2-year rodent bioassay of cumene showed clear evidence of carcinogenicity (TR-452).

  • Type: Notice
  • February 23, 2012
  • 77 FR10754
98-82-8
2012 EPA
National Emission Standards for Hazardous Air Pollutants From Coal- and Oil-Fired Electric Utility Steam Generating Units and Standards of Performance for Fossil-Fuel-Fired Electric Utility, Industrial-Commercial-Institutional, and Small Industrial-Commercial-Institutional Steam Generating Units

On May 3, 2011, under authority of Clean Air Act (CAA) sections 111 and 112, the EPA proposed both national emission standards for hazardous air pollutants (NESHAP) from coal- and oil-fired electric utility steam generating units (EGUs) and standards of performance for fossil-fuel-fired electric utility, industrial-commercial-institutional, and small industrial-commercial-institutional steam generating units (76 FR 24976). After consideration of public comments, the EPA is finalizing these rules in this action.

NTP Information Cited
NTP 2-year rodent bioassay of Ni sulfate hexahydrate (water soluble) showed no evidence of carcinogenicity (TR-454); NTP 2-year rodent bioassay of Ni subsulfide showed clear evidence of carcinogenicity (TR-453); NTP’s Report on Carcinogens states considering Ni compounds to be carcinogenic as a group (ROC).

  • Type: Final Rule
  • February 16, 2012
  • 77 FR 9304
10101-97-0
12035-72-2