An Assault on Public Protections: Regulatory Policy News in 2008
by Rick Melberth*, 12/16/2008
The federal government's ability — and sometimes inability — to protect the public drew national attention throughout 2008. President Bush's and senior administration officials' aversion to regulation and their penchant for allowing the market to operate unchecked appeared more and more outmoded in the face of the collapse of the financial market, the rising tide of dangerous imported products, and persistent examples of environmental degradation.
Throughout 2008, the Bush White House continued to meddle inappropriately in the affairs of regulatory agencies by distorting science, changing policy outcomes, and inventing a system whereby new agency rules would leave the incoming Obama administration with the task of implementing Bush-era priorities.
White House Interference
In April, the U.S. Environmental Protection Agency (EPA) announced it was changing its process for studying the risks of toxic chemicals under its Integrated Risk Information System program. The changes give the White House Office of Management and Budget (OMB) — an office with little scientific knowledge — a greater role in the risk assessment process.
EPA will now involve OMB at every stage of the IRIS assessment process. OMB already reviews — and often edits — agencies' proposed and final regulations. The office will now have several opportunities to review and alter the scientific findings that serve as the basis for chemical exposure standards.
OMB and EPA have stuck by the changes despite criticism from Congress, a critical report from the Government Accountability Office (GAO), and objections of EPA staff over the role of OMB in agency science.
OMB also continued to alter the substance of individual agency rules. In most cases, OMB's interference weakened requirements proposed at the agency level. For example:
- In March, President Bush himself stepped in to force EPA to abandon its plan to set a seasonal standard for ozone exposure tailored especially to the needs of plant life. OMB challenged the scientific basis for EPA's decision and encouraged the agency to consider the economic impact of the new standard, even though the Clean Air Act prohibits EPA from weighing costs in setting air standards. After EPA resisted the pressure, Bush was brought in to arbitrate the dispute and sided with OMB.
- In October, EPA tightened the national public health standard for airborne lead, drawing rare praise from clean air advocates. However, shortcomings in the network for monitoring lead pollution persist. EPA was prepared to require installation of new monitors near facilities emitting 1,000 pounds or more of lead pollution. But an e-mail exchange between EPA and OMB less than 48 hours before the final rule was announced shows that OMB pressured EPA to raise the threshold to 2,000 pounds. The change means state and local officials will not be required to place new pollution monitors near at least 124 facilities that emit lead.
- The White House also watered down a rule expanding protections for the endangered North Atlantic right whale. The National Oceanic and Atmospheric Administration (NOAA) initially proposed extending the protection area in which the new rule would be enforced to 30 nautical miles off shore. When NOAA announced the final rule in October — after a White House review that lasted 573 days — the protection zone had shrunk to only 20 nautical miles.
OMB directed its most strident opposition toward new regulations that would have addressed climate change. The White House completely dismantled the efforts of EPA staff to curb greenhouse gas emissions.
A House investigation into EPA's 2007 decision to prohibit California from adopting its own tailpipe emissions controls showed the White House may have played a role in denying the state's climate change policy. EPA Administrator Stephen Johnson had been willing to grant California's request but changed his mind after a meeting with White House officials, according to the House report released in May 2008. The denial precludes as many as 19 other states from adopting similar emissions reduction programs.
The White House also blocked federal efforts to reduce greenhouse gas emissions. After developing a regulatory roadmap to reduce both vehicle and stationary source emissions, White House officials prohibited EPA from releasing its plans to the public.
In response to a 2007 U.S. Supreme Court decision, EPA began to develop documents showing that climate change poses a danger to the public and a regulatory plan for addressing climate change by reducing greenhouse gas emissions.
But when EPA sent the material to OMB for review, OMB refused to open the e-mail. OMB officials feared the documents would make a compelling case for greenhouse gas regulation.
By March 2008, EPA completely abandoned its plans to begin regulating emissions. Johnson pledged to issue a so-called Advanced Notice of Proposed Rulemaking (ANPRM), which would only solicit opinions on climate change and regulatory methods for addressing it. The ANPRM, published in July, proved a disappointment. OMB prodded the agency to delete references to climate change's impact on public health and welfare.
Still not content, the White House distanced itself from the notice. Susan Dudley, head of the OMB's regulatory clearinghouse, the Office of Information and Regulatory Affairs (OIRA), said the policy "cannot be considered Administration policy or representative of the views of the Administration."
Other letters of disapproval came from the heads of the departments of Agriculture, Commerce, Energy, and Transportation; the White House Council of Economic Advisors and the Office of Science and Technology Policy; the Small Business Administration Office of Advocacy; and the White House Council on Environmental Quality.
A flurry of regulatory activity at year's end, prompted by the White House, stands in stark contrast to the pattern of obfuscation discussed above. The Bush administration launched a broad midnight regulation campaign in an attempt to leave an administrative legacy.
In May, the White House laid down a path for agencies to follow. White House Chief of Staff Joshua Bolten issued a memo instructing agencies to propose by June 1 rules they wished to finalize under Bush's watch and to finalize all rules by Nov. 1. The November deadline would prove the more critical one.
The administration worked furiously through the summer months. In spite of Bolten's June 1 deadline, agencies proposed rules intended to limit women's access to reproductive health services, open broad swaths of land in the west to energy development, and systematically alter the scientific basis for future rules that protect industrial workers from exposure to toxic substances.
An Interior Department rule on the Endangered Species Act moved at warp speed. In August, Interior proposed allowing federal land-use managers to approve projects like infrastructure creation, minerals extraction, or logging without consulting habitat managers and biological health experts responsible for species protection.
The proposal met with fierce opposition. Interior received about 300,000 public comments, mostly negative, on its proposal after it was unveiled in August. According to an internal e-mail obtained by the Associated Press, Interior tried to review all the public comments in just four days, or about seven comments per minute.
By November, the campaign began to bear fruit when agencies completed several rules. The Department of Transportation finalized a rule allowing truck drivers to drive up to 11 consecutive hours and shortening required rest times. A Department of Labor rule announced in November will make it more difficult for workers to take unpaid leave to care for themselves or a family member. The administration even pushed through cuts to Medicaid — a particularly dubious decision considering the current economic climate.
The pace only accelerated in December. Many of the rules target the environment. Rules finalized in the first half of December would:
- Make it legal for mining companies to dump into rivers and streams the waste generated from mountaintop mining
- Exempt farms from reporting air pollution generated from animal waste
- Lift the 25-year-old-ban on carrying loaded weapons in national parks
- Remove the requirement for scientific consultation under the Endangered Species Act (as discussed above) and eliminate climate change as a factor in decisions about species protection
Bush's flurry of last-minute activity is typical for presidents in their waning days of power. President Bill Clinton generated tomes of Federal Register pages with his last-minute rules. As late as Friday, Jan. 19, 2001, the Clinton administration was sending rules to the Office of the Federal Register for publication the following Monday, when Bush would have already taken power.
But Bush's 11th hour push, pursued with great forethought and shrewdness, may prove more successful than Clinton's. Even after a rule is finalized and published in the Federal Register, agencies must wait at least 30 or 60 days (depending on the significance of the rule) before making the rule effective. Since Clinton waited until January 2001 to issue rules reflecting his priorities, Bush administration officials maintained some discretion to reevaluate those rules not in line with their views. As a result, several rules finalized and published under Clinton were killed by the new Bush officials.
Now Bush appears to be trying to prevent Barack Obama from doing to him what he did to Clinton. Since the Bush administration finalized many of its rules in November and December, that 30- or 60-day window will be closed come Jan. 20, 2009. Sixty-day rules finalized before Nov. 20 will take effect, as will 30-day rules finalized by Dec. 19.
The Bush administration continued to ignore or downplay scientific evidence in its strategy to protect businesses from what it sees as a burdensome regulatory process. This is a continuation of the approach the administration has taken on so many public policy issues, from environmental protection to public health.
The U.S. Food and Drug Administration (FDA) continues to claim that there is insufficient evidence about the health effects of bisphenol-A (BPA), a chemical widely used in consumer products, to justify regulating the substance. Despite mounting evidence that BPA may affect human development and mental health, FDA continues to advise consumers that there is no reason to "discontinue using products that contain BPA."
The latest evidence on BPA are a Yale School of Medicine study that links the chemical to brain functions and mood disorders and a study published in the Journal of the American Medical Association (JAMA). The Yale study concluded that exposure to the chemical may result in memory loss, brain impairment, and depression at the exposure level the EPA has established as safe. (EPA has the responsibility for setting safe chemical exposure limits, while FDA can limit or ban the use of BPA in food-related items.)
The JAMA study was conducted by a team of British and American scientists and compared the level of BPA in human urine. They discovered a link between exposure and diabetes and heart disease. This and other recent studies follow earlier analyses of BPA that led to warnings and product withdrawals.
FDA, meanwhile, continues to claim the science regarding BPA is too uncertain to warrant regulation of the chemical in food products and is not recommending consumers change their habits regarding BPA-based products. An Aug. 14 Draft Assessment of Bisphenol A for Use in Food Contact Applications being circulated for FDA's scientific peer review program concludes that there is no adverse health effect from BPA. The draft assessment continues to rely heavily on two industry-funded studies that formed the basis of FDA's earlier assessment of BPA.
EPA has also balked in the face of scientific evidence. The agency routinely ignores recommendations from an advisory committee established to assist it in creating policies to protect children's health. On Sept. 16, a GAO official told a Senate panel that the advisory committee was "to provide advice, information, and recommendations to assist the agency in the development of regulations, guidance, and policies relevant to children's health." Committee members include public health officials from government, nonprofits, academia, industry, and health care organizations.
GAO concluded that in more than 30 meetings of the advisory committee in the first ten years, "EPA has rarely sought out the committee's advice and recommendations to assist it in developing regulations, guidance, and policies that address children's health." EPA requested advice from the committee on regulations only three times, on guidance three times, and only once on developing a policy. Yet the committee sent over 600 recommendations for action to EPA on issues like particulate matter, ozone, lead, pesticides, mercury regulation, and farm worker protections over the period that GAO reviewed.
Before the White House watered down a new rule to expand protection for the North Atlantic right whale, as mentioned above, it delayed finalizing the rule while the office of Vice President Dick Cheney and other executive offices questioned the findings of scientists at NOAA. NOAA proposed speed limits on large ships traveling in Atlantic Ocean whale migration areas during seasons when the right whale is most active. Collisions with ships are a major cause of death of the right whale, one of the most endangered whale species in the world, according to NOAA.
The White House Council of Economic Advisors (CEA) changed and reanalyzed statistics in a model intended to determine the relationship between ship speed and the risk to right whales. Based on the recalculations, the CEA called NOAA's analysis "biased." Cheney's staff "contends that we have no evidence (i.e., hard data) that lowering the speeds of 'large ships' will actually make a difference." In response, NOAA staff cited records of collisions in which right whales were killed or seriously injured and again argued in favor of ship speed limits.
The right whale rule was sent to OIRA in February 2007. OIRA is supposed to complete its review within 120 days but held the right whale protection rule for 21 months. OIRA finally gave its approval Sept. 15, and NOAA published a weakened rule Oct. 10. The rule went into effect Dec. 9, according to NOAA's website.
Product safety issues remained a concern in 2008, although there were fewer crises in both food and consumer items than in 2007. Congress made progress in restoring some of the government's ability to safeguard products, but some incidents underscored how much work remains.
In July 2008, Congress reached agreement on legislation to enable the Consumer Product Safety Commission (CPSC) to better enforce safety standards in markets dominated by cheap imports and required new standards for dangerous substances like lead and phthalates. After months of negotiations, dating back to 2007, Congress passed the Consumer Product Safety Improvement Act of 2008, and President Bush signed the bill into law Aug.14.
The act authorizes increases in CPSC's budget to $136 million by FY 2014, nearly a 75 percent increase over current levels. However, the increases must still be appropriated in the spending bills Congress takes up each year. One part of the bill bans certain phthalates, a class of chemicals found in a variety of plastic products, from children's toys. Three other phthalates are banned temporarily pending further study. This action represents a dramatic shift in the government's approach toward regulating toxic substances. Usually, chemicals enter and stay on the market without regulation and are only pulled if scientists prove a definitive health risk. In this case, the banned substances will only be allowed back on the market if their safety is proven. The act also bans lead in children's products to trace amounts. (Read a summary of the bill's contents here.)
The inability of government agencies to track food sources during foodborne illness outbreaks was again illustrated in the spring and summer months. Federal officials had significant difficulty providing consumers with information on two separate outbreaks. Investigators searched for months for the source of a salmonella outbreak, and officials were unable to provide detailed information for consumers on a batch of E. coli-contaminated beef, which had spread to a number of states across the country.
FDA announced a warning against consuming certain types of raw, red tomatoes June 7 after more than 100 consumers had been sickened by a rare strain of salmonella. But more than a month after announcing the warning, and almost three months since the first cases of salmonella were reported, the FDA still had not pinpointed the source of the contamination. The FDA subsequently expanded its investigations to include peppers and cilantro. After a three-month investigation focusing mainly on tomatoes, FDA traced the contamination to serrano and jalapeño peppers imported from Mexico. The outbreak sickened 1,442 people in 43 states, Washington D.C., and Canada.
The U.S. Department of Agriculture (USDA) also left consumers in the dark after an E. coli outbreak was linked to contaminated beef. In a June 30 announcement, USDA recalled half a million pounds and covered shipments sent to processors and wholesalers in Colorado, Illinois, Michigan, Nebraska, New York, Pennsylvania, and Texas.
On July 3, USDA expanded the recall to 5.3 million pounds. While USDA quickly identified the source of the contaminated beef — Nebraska Beef in Omaha — it gave no further indication as to where the Nebraska company had shipped the contaminated beef or how processors, wholesalers, retailers, and consumers could identify it.
A public health crisis originally thought to be limited to China crept into the U.S. when on Sept. 26, FDA announced recalls of products tainted by melamine. Then, on Oct. 3, FDA announced a new standard for melamine. FDA released an interim assessment that determined melamine to be safe in food at levels of 2.5 parts per million or lower while simultaneously saying that no amount of melamine in baby formula is safe. On Nov. 28, FDA reversed its baby formula position and set an allowable standard of one part per million of melamine if certain other chemicals are present, according to a Washington Post article.
The melamine recalls reignited concern over FDA's ability to adequately police the rising tide of imported food reaching American consumers. From 2002 to 2007, food imports increased 84 percent, according to the GAO.
In response to the many pressures put on FDA by the import safety crisis, Department of Health and Human Services (HHS) Secretary Michael Leavitt announced Oct. 16 that FDA would start to send personnel overseas to staff offices to help ensure the safety of imported food and drugs. The plan calls for staff to be assigned to offices in China, India, Europe, and Latin America. Many assignments will begin before the end of 2008. A total of eight U.S. officials will operate in China. Ten employees will be posted in India once arrangements are negotiated with Indian officials. Other offices will open in nine Latin American countries, in Europe, and in the Middle East, according to an FDA press release.
The FDA staff will work with government officials and the companies producing the goods in an effort to improve quality assurance. They will inspect facilities, provide technical assistance, and help create third-party certification programs, according to the announcement. The certification programs require HHS to accredit independent organizations that would inspect manufacturing and production facilities and declare that the products meet U.S. import standards. Once their facilities are certified, the firms' products would gain expedited entry at American ports. Companies that do not meet certification would continue to work with FDA staff and government officials to improve the safety of their products.
The hostility exhibited by the Bush administration toward public protections has increasingly come under fire in the last few years. The importance of government's role in safeguarding so many aspects of our lives is illustrated most starkly by the impact of — and the public's shock at — the failure to regulate the financial and housing sectors. This failure comes on the heels of the threats from poorly regulated consumer products and the relentless attack on environmental protections. The time has come for a new administration and Congress to make real efforts to reform a badly broken regulatory process.