Rules to Watch for in 2011

Federal agencies have released their rulemaking agendas for 2011, providing the public with a roadmap of the health, safety, and environmental safeguards it can anticipate in the new year.

Each spring and fall, the executive branch publishes the Unified Agenda of Regulatory and Deregulatory Actions, commonly called the Unified Agenda. The agenda includes the individual rulemaking agendas for all executive branch agencies, including independent commissions. Agencies post online brief descriptions of their rules and projected timetables for milestones and completion.

The fall version of the Unified Agenda is supposed to be released in October. However, the 2010 version was not released until Dec. 20. No explanation was given for the delay. Below are descriptions of select rulemakings covered in the agendas of major health, safety, and environmental agencies.


The rulemaking agenda of the U.S. Environmental Protection Agency (EPA) continues to emphasize the fight against climate change. The agency will continue to write rules to limit greenhouse gas emissions from stationary sources like coal-fired power plants and oil refineries. Under a 2010 greenhouse gas rule, certain sources began requesting permits at the beginning of 2011.

EPA is also in the midst of two joint rulemakings with the National Highway Traffic Safety Administration (NHTSA) to cut greenhouse gas emissions from vehicles. The agencies expect to finalize in August a rule cutting emissions from heavy-duty vehicles and are in the early stages of developing fuel efficiency standards for passenger vehicles manufactured for model years 2017 and beyond. In 2010, the agencies finalized standards for model years beginning in 2012 that set miles per gallon requirements of up to 34.1 mpg by 2016.

EPA projects it will finalize in July the Clean Air Transport Rule, a regulation aimed at emissions that cross state lines and impact downwind states. EPA estimates the rule could prevent as many as 36,000 premature deaths every year.

EPA also expects that it will propose adding to its chemicals of concern list certain phthalates, compounds often found in soft plastics, as well as bisphenol-A, found in hard plastics and the lining of food containers. The agency had hoped to propose adding the chemicals to the list by September 2010, according to the last Unified Agenda (April 2010), but the notice has been held up at the White House Office of Information and Regulatory Affairs (OIRA) since May 2010. OIRA, the clearinghouse for all significant rules and notices, is supposed to spend no more than 120 days reviewing agency drafts.

EPA now lists its pending regulation of coal ash as a “long-term action.” EPA decided to regulate coal ash, a byproduct of coal combustion that can contain arsenic, lead, chromium, and other heavy metals, after an impoundment in Tennessee failed in December 2008, releasing 5.4 million cubic yards of coal ash. Reports have linked exposure to the toxic components in coal ash to cancer and other health problems.

After a lengthy and tumultuous interagency review, EPA proposed coal ash rules in May 2010. The rulemaking has been the subject of intense debate. Environmentalists want the agency to regulate coal ash as a hazardous waste, while industry groups want coal ash to be treated like common waste, which would lead to fewer restrictions. EPA now lists the date of final action as “to be determined,” suggesting the agency may be uncertain as to its course of action in the face of political and industry pressure.


The Occupational Safety and Health Administration (OSHA) will continue to emphasize the Department of Labor’s “Plan/Prevent/Protect” initiative, first announced when the last Unified Agenda was released in April 2010. OSHA is developing two rules implementing Plan/Prevent/Protect. The first would require employers to plan, implement, and maintain injury and illness prevention programs to reduce occupational risks. The other would create an infection control program to protect workers from infectious diseases. During a Jan. 5 web event marking the release of the current agenda, OSHA called the injury and illness prevention rule its “highest regulatory priority.” Both rules are in the earliest stages of development.

OSHA expects to make progress in 2011 on two long-delayed rulemakings. OSHA says it will publish in April a proposed rule to address the risks of crystalline silica. The substance is a known carcinogen, and workers exposed to it can develop sometimes fatal illnesses. OSHA’s crystalline silica rulemaking first appeared in the Unified Agenda in 1997. OSHA also plans to publish in November a final rule protecting workers operating in confined spaces. It has appeared on the Unified Agenda since the 1990s.

OSHA still expects to finalize a rule restoring the musculoskeletal disorder reporting column to the form employers fill out when a worker is injured. OSHA hopes the form change will provide the agency with more reliable information on musculoskeletal injuries. OSHA had expected to finalize a rule in July 2010. The agency submitted the rule to OIRA on July 14, 2010, but the White House has yet to approve it. The Unified Agenda projects final publication in February.

Other OSHA standards continue to develop slowly. The agency does not expect to propose in the near future standards for beryllium or diacetyl, two dangerous chemicals, despite the fact that the rulemakings have appeared in versions of the Unified Agenda for years. The current agenda also lacks a proposed rule for combustible dust, a hazard that led to 119 deaths and 718 injuries between 1980 and 2005, according to the U.S. Chemical Safety Board.

The Mine Safety and Health Administration (MSHA) says that it will publish in January new rules for its Pattern of Violations (POV) program. The program came under scrutiny in the wake of the April 2010 explosion at the Upper Big Branch mine in West Virginia that killed 29 miners. Although the Upper Big Branch mine operators and its owner, Massey Energy, had a clear history of safety and health violations, MSHA had been unable to place the mine on its POV list, a move that triggers increased oversight of a mine. Companies can avoid being listed in the program by appealing violations. MSHA has never placed a mine on the POV list in the program’s 32-year history.

The Unified Agenda does not project a date for the completion of an MSHA rule to reduce the risk of black lung disease. In October 2010, MSHA proposed cutting in half the exposure standard for coal dust, the cause of black lung. MSHA estimates the new standard would prevent thousands of illnesses and hundreds of deaths over the lifetimes of miners.


Food safety efforts at the Food and Drug Administration (FDA) are centered on the labeling of food products. Among other items, the agency expects to propose two rules in March: one setting nutrition labeling requirements for food sold in vending machines and another for standard menu items at chain restaurants.

The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS), the regulator of meat and poultry products, continues to struggle to set up a safety inspection program for catfish. The Unified Agenda projects a proposed rule creating the program in December 2010 – a date the agency has obviously missed. The agency was under a statutory deadline to create the program by December 2009, but the implementing rule has been held by OIRA since November 2009.

On the medical product front, FDA expects to finalize in October tighter standards for direct-to-consumer advertising of drug products on TV and radio. FDA is also planning an August final rule changing the way pharmaceutical companies report potential safety problems after a drug is on the market. The postmarketing rulemaking comes on the heels of a similar rule, finalized in 2010, that changed premarketing reporting requirements.

FDA will also continue to implement the Family Smoking Prevention and Tobacco Control Act, signed into law in 2009. The law granted the FDA regulatory authority over cigarettes and other tobacco products. In 2011, FDA will develop standards for cigars and finalize new, graphic warning labels “depicting the negative health consequences of smoking” cigarettes.


The Consumer Product Safety Commission (CPSC) continues to write rules implementing the Consumer Product Safety Improvement Act, the landmark 2008 law that overhauled product safety and placed a renewed emphasis on children’s product safety. Among other items, CPSC expects to make progress in 2011 on the law’s requirements that certain products pass third-party safety tests. CPSC is currently developing rules for third-party testing of toys and of children’s products containing phthalates, exposure to which has been linked to reproductive and developmental abnormalities.

NHTSA will soon propose revisions to its standards for acceleration control systems in passenger vehicles, according to the Unified Agenda. NHTSA says the revision is necessary because most carmakers have shifted from mechanical throttle controls to electronic or computerized controls. It is unclear whether the rule will address the problems highlighted in the recall of millions of Toyota vehicles in 2009 and 2010. Many of those vehicles were recalled after reported incidents of sudden, uncontrolled acceleration. NHTSA is still investigating the defect.

NHTSA is also mulling a proposed rule that would require new cars to be equipped with rear cameras that allow drivers to maintain a more complete view of the space behind them. The standard would help reduce the number of accidents in which drivers inadvertently back into people, other vehicles, or other objects, according to NHTSA.

Other NHTSA rules include a standard for new vehicles intended to reduce the risk of occupants being ejected during a crash and a requirement that commercial motorcoaches, such as tour buses, be equipped with seatbelts. A final ejection mitigation rule is expected in January 2011, and a final seatbelt rule is expected in January 2012.

The entire Fall 2010 Unified Agenda is available at The next Unified Agenda is due to be published in April.

Image in teaser by flickr user Brain farts, used under a Creative Commons license

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