Two stories today highlight the problems with tracking the path of contaminated food through the supply chain and how those problems impact public health.

In the first story, from Washington Post reporter Annys Shin, we learn federal officials are now backing away from their earlier claim that tomatoes are responsible for the recent outbreak of a rare strain of salmonella. The news — a significant step backwards in identifying the problem, ensuring public health, and restoring peace of mind — comes more than three weeks after the tomato scare burst into the headlines.

Shin quotes FDA food safety official David Acheson as saying, "The tomato trail is still hot. It's a question of whether other items are getting hotter."

The complexity of the supply chain — which shuffles tomatoes and other produce across state and national boundaries for processing, packaging, and distribution — makes identifying the source of the contamination nearly impossible for FDA. Combine that difficulty with the FDA's resource shortfalls and the Bush administration's rosy outlook on product safety and the situation becomes even grimmer.

Meanwhile, as Shin reports, "The outbreak has sickened 869 people in 36 states and the District of Columbia since mid-April." The latest case of illness was reported June 20, two weeks after FDA's national warning.

The other story, from Columbus Dispatch reporter Misti Crane, concerns a beef recall targeted in Ohio and Michigan. Nebraska Beef, which supplies Kroger grocery stores, announced the recall after an outbreak of E. coli. Unfortunately, Crane reports, the recall "does not give information that's likely to help you figure out if what's in your refrigerator or freezer is harmful."

So while the recall has only been linked to illnesses in Ohio thus far, its effects could be much broader:

The nearly 532,000 pounds in question might have been mixed into an undetermined number of pounds of ground beef. It is common practice in meat-grinding facilities to combine product from multiple sources.

Beef parts from Nebraska Beef went to other companies in the state and to companies in Colorado, Illinois, Michigan, New York, Pennsylvania and Texas.

In the area of food safety, it seems like history is repeating itself over and over. A public health crisis prompts a federal response; but officials soon realize they are handcuffed by lack of information and lack of resources. Consumers are left in the dark, barely placated by government promises and too ill-informed to make decisions that could help them protect themselves and their families. Eventually the problem just fades away (for those not sickened by the food in question), with lessons never learned.

Yesterday, six controversial rules that would have reduced federal funding for Medicaid programs were put on hold until at least April 2009. Congress included moratoria on the rules as a provision in the war supplemental bill which President Bush signed into law. (H.R. 2642; see section 7001 for the moratoria.)

The Bush administration had finalized, or was preparing to finalize, the regulations in an effort to cut federal funding for a variety of Medicaid programs administered by the states. The regulations would have cut funding for services that help those with mental illness and intellectual disabilities and for children in foster care, among other services.

Bush had threatened to veto a stand-alone moratoria bill. Fortunately for states and Medicaid beneficiaries, Congress was able to attach the provision to the war supplemental. Regardless, the regulations are so unpopular among congressmen both houses of Congress approved the provision with veto-proof margins.

Passage of the bill means, hopefully, the Bush administration will not be able to monkey around with Medicaid for the remainder of its tenure.

The U.S. Environmental Protection Agency is close to finalizing its Advanced Notice of Proposed Rulemaking (ANPRM) on greenhouse gas emission regulation. The ANPRM is an indication that EPA may someday consider taking a look at possibly addressing global warming through some sort of undefined future action…perhaps.

Even still, the White House Office of Management and Budget (OMB) is all over the document like stink on a monkey.

The Wall Street Journal has gotten a sneak peak at the document and reports on it this morning: "The draft document…outlines how the government, under the Clean Air Act, could regulate greenhouse gas emissions…"

The Journal goes on to identify OMB's likes and dislikes:

The White House's Office of Management and Budget has asked the EPA to delete section of the document that say such emissions endanger public welfare, say how those gases could be regulated, and show an analysis of the cost of regulating greenhouse gases in the U.S. and other countries.

The OMB instead wants the document to show that the Clean Air Act is flawed …

In 2007, EPA promised — in response to a Supreme Court decision mandating it consider greenhouse gas regulation under the Clean Air Act — to actually take action greenhouse gas emissions through a notice of proposed rulemaking. But in March, EPA announced instead that it would pursue the ANPRM.

At the time, there was no proof of White House interference. However, recent reports show that OMB blocked EPA's proposal. As The New York Times reported last week, OMB went so far as to refuse to open an email containing EPA's proposal.

EPA and White House officials maintain that Johnson made the ultimate decision to punt on greenhouse gas regulation, but the evidence indicates otherwise. As we've seen with the California waiver decision and the revision to the national standard for smog, Johnson is merely a puppet for the White House.

OMB is calling the shots on seemingly every major environmental policy decision; it is running roughshod over agency scientists, ignoring the plain language of federal law, and disregarding court orders.

Jason Burnett, an associate administrator for EPA, recently resigned in frustration. The Washington Post reports on his sad yet accurate assessment:

Burnett refused to comment on the White House calls but said in an interview, "In early December, I sent an e-mail with the formal finding that action must be taken to address the risk of climate change," adding that he resigned his political appointment because the agency had been stymied in its efforts to respond to the Supreme Court. "The White House made it clear they did not want to address the ramifications of that finding and have decided to leave the challenge to the next administration. Some [at the White House] thought that EPA had mistakenly concluded that climate change endangers the public. It was no mistake."

Andrew Schneider, a reporter for the Seattle Post-Intelligencer, has a blog post on CDC's estimate of how many people may actually have been sickened by the recent outbreak of salmonella in tomatoes:

The CDC reported last night that outbreaks of the saintpaul strain of salmonella has been documented in 28 states, with 277 people sick and 43 of those hospitalized.

And the federal disease detectives released this fascinating number: More than 8,000 people may have actually been sickened in this outbreak, but no one will ever know for sure.

"Most cases of salmonellosis are not reported because some people who are ill do not seek medical attention and not all patients who seek medical care submit specimens for culturing," said a CDC spokesperson.

Based on earlier extensive studies and extrapolations, the CDC has estimated that for every one case of salmonellosis reported there are 38 additional cases that are not reported.

As tomatoes from approved areas begin to return to stores and restaurants (a local Chipotle has brought back its mild tomato salsa, much to Reg•Watch's delight), FDA appears to have shed little light on the mystery. The Los Angeles Times reported yesterday, "Consumers and farmers have criticized health officials for the slow pace of the probe, which the FDA says is unavoidable because of the wide scope of the outbreak, the shaky memories of victims and the difficulties of tracing tomatoes. As a result, shoppers have shunned the fruit and growers have suffered plunging sales."

Thus is the public health and economic toll of FDA's broken down regulatory system.

Where's Congress?

While the growing complexity of the global supply chain and years of anti-government conservatism in Washington may have brought us to the point where food safety failures routinely make headlines, the Democratic-led 110th Congress is doing little to help.

The Center for Science in the Public Interest, a nonprofit group that works on food safety and other important causes, has a list of food safety bills currently pending in Congress. CSPI lists 12 different bills, not one of which has cleared the committee stage.

On Tuesday, a House Energy and Commerce Committee subcommittee held a hearing titled, "Safety of Phthalates and Bisphenol-A in Everyday Consumer Products." Bisphenol-A (BPA) and phthalates, both of which are common ingredients in plastic products, have come under fire recently for their potential risk to human health.

FDA's Associate Commissioner for Science, Norris Alderson, testified, saying, "A largebody of available evidence indicates that food contact materials containing BPA currently on the market are safe, and that exposure levels to BPA from these materials, including exposure to infants and children, are below those that may cause health effects."

That's been the standard response from the agency as public concern about BPA rises. However, FDA is renewing its research on the chemical, as Reg•Watch blogged earlier this week.

Late last week, FDA's lead scientist asked the agency's science board to convene a subcommittee to study the effects of BPA. The primary responsibility of the subcommittee will be to review an FDA task force report on BPA exposure and effects. "In April 2008, the FDA formed an agency-wide BPA Task Force to facilitate review of current research and new information on BPA," FDA says. After the subcommittee reviews the report this summer, "the task force will make recommendations" to the FDA commissioner.

During the hearing, Alderson, the chair of the task force, acknowledged the research could lead to regulatory action, saying, "[I]f FDA's review of data leads us to a determination that uses of BPA are not safe, the Agency will take action to protect the public health."

Because BPA is a common ingredient in the lining of metal food cans, the chemical would be ripe for FDA regulation if found to be harmful.

If FDA takes no action on BPA, Congress might. Committee member Rep. Edward Markey (D-MA) has introduced legislation that would ban BPA in food and drink containers. Because the prospects of bill's passage in the U.S. Congress are positively correlated with the cleverness of its acronym, Markey has named the bill the Ban Poisonous Additives (BPA) Act (H.R. 6228).

Rep. Brad Miller (D-NC) wrote to the White House June 11 asking about the Office of Management and Budget's role in EPA's revised process for assessing the health effects of industrial chemicals. EPA announced changes to the process, known as the Integrated Risk Information System (IRIS), in April.

One of the major problems with the revised process is the lack of transparency. OMB and other federal agencies will be able to have input into a chemical assessment without ever disclosing their views — scientific or political — to the public. Miller wrote to Susan Dudley, the head of OMB's Office of Information and Regulatory Affairs (OIRA), which will coordinate the OMB/interagency review of IRIS assessments, expressing his concern:

[T]he interagency process OIRA manages is secret. The public has no insight into who is being invited to discuss what, when. The public has no way of getting at materials associated with those discussions because the pre-decisional exemption of the Freedom of Information Act (FOIA) applies to all of those materials.

The bottom line is that if the interagency discussion taking place is solely about science, there is no reason why that discussion and all communications surrounding it, cannot survive the light of exposure to the public. The only reason to hide a discussion about science is if the discussion is actually not about science, but about other things that are being used to trump the science.

Miller is the chair of the House Science Committee subcommittee on Investigation and Oversight. Yesterday, the subcommittee held its second hearing on the changes to the IRIS process.

During the hearing, ranking member James Sensenbrenner (R-WI) discussed another problem with the revised process: the delayed completion of IRIS assessments and subsequent backlog of chemicals needing to be assessed. Sensenbrenner pointed out that EPA has completed only two IRIS assessments in each of the last two years, and called the process "broken down."

Sensenbrenner then addressed the OMB/interagency review which will allow other federal agencies, such as the Department of Defense or NASA, to delay the assessment process:

[EPA] argues that it can expedite the IRIS process by involving other agencies earlier in the process. While preventing last minute delays is an important reform, the ability of other agencies to extend the time frame of assessments should be sharply limited. Data gaps in risk assessments will always exist, as better science is always developing. The EPA needs to limit the time frame of assessments to prevent other agencies from indefinitely delaying the process.

For more information on the changes to the IRIS process, see this OMB Watch factsheet.

In this video, OMB Watch Executive Director Gary Bass discusses the importance of public protections; the Bush administration's track record on such protections; and what the American people can do to take our country back from the big-monied special interests that are endangering our health and safety.

You can also leave comments on our YouTube page with suggestions for future videos.

The New York Times reports today on the salmonella outbreak in tomatoes that has caused restaurants, grocery stores, and major fast food chains like McDonald's to go tomato-free over the past few days.

Saturday, the Food and Drug Administration (FDA) announced three prominent tomato varieties — red plum, red Roma, and red round — have been implicated in a recent outbreak of a rare strain of salmonella that has sickened scores of people.

A national warning against the consumption of any of the most common types of tomatoes underscores two major problems with our food safety system: tracking and prevention.

According to FDA, illnesses have been reported in 16 states from Connecticut to California. The Times reports an FDA spokeswoman as saying, "We are getting closer to identifying the source or sources."

Considering FDA has known since April about selected incidences associated with the now-wider outbreak, FDA's comments do not engender much confidence. The size of the produce market and the growing complexity of the supply chain make it virtually impossible to track the source of a contaminated batch.

Meanwhile, consumers are left in the dark. Tomato-eaters will have difficulty identifying whether a tomato is from an affected area (FDA says tomatoes from eight states have not been associated with the outbreak) or what they can do to protect themselves. (Click here for more on the public disclosure problem from Andrew Schneider at the Seattle Post-Intelligencer.)

FDA is also ill-equipped to prevent these kinds of outbreaks, now or in the future. From Times reporter Gardiner Harris:

[H]ealth experts said that the many problems that have caused food recalls in recent years, including those involving peanut butter, cantaloupe and spinach, were likely to worsen….

And federal authorities have yet to create a stronger set of rules and enforcement procedures. Many parties — food-safety advocates, food producers, Congressional Republicans and Democrats and even some within the F.D.A. — have said such rules are essential to make food safer.

The massive warning on tomatoes may have persuaded President Bush to finally push some federal funding toward consumer safety. Monday, the White House sent Congress a supplemental appropriations request, asking the legislature to give the FDA an extra $275 million for fiscal year 2009 — about 15 percent more than Bush's initial request.

$125 million of that money is to go toward food safety. The rest would go toward drug safety, medical device safety, and modernizing the agency's workforce.

Over the past few years, the FDA's woes have piled up. The beleaguered agency has struggled to ensure the safety of the nation's food and drug supply. Imported products have proved increasingly vexing; the agency has been unable to adapt its monitoring and enforcement practices in a rapidly changing world economy.

Much of FDA's plight has been attributed to a lack of resources, particularly a lack of inspectors. While Congress has expressed bipartisan support in favor of a dramatically increased budget, the Bush administration, until now, has been lukewarm on the idea.

Lawmakers welcomed the increased budget request but want it implemented post-haste:

[Sen. Arlen] Specter said that administration delays in seeking money for food protection efforts at the food and drug agency amounted to "criminal negligence."

"The failure to have these inspections is subjecting people to bodily injury and death," said Mr. Specter, who sent a letter to Mr. Leavitt on Tuesday insisting that the additional money for the F.D.A. should be included in a supplemental request this year, not in next year's budget.

Late last week, FDA's lead scientist asked the agency's science board to convene a subcommittee to study the effects of bisphenol-A (BPA), a chemical commonly found in hard plastics and food containers. The science board is an advisory committee of non-governmental scientists who provide expert advice to FDA decision makers.

From the FDA press release, it appears as though the primary responsibility of the subcommittee will be to review an FDA task force report on BPA exposure and effects. "In April 2008, the FDA formed an agency-wide BPA Task Force to facilitate review of current research and new information on BPA," FDA says. After the subcommittee reviews the report this summer, "the task force will make recommendations" to the FDA commissioner.

The increased activity at FDA comes less than two months after a report by the National Toxicology Program (NTP), which, like FDA, is part of the Department of Health and Human Services, raised concern about the possible health effects of BPA.

The NTP report finds most humans are exposed to BPA and retain it in their bodies. The panel looked at studies of laboratory rodents exposed to BPA and found a wide variety of adverse health effects at high doses and other possible health effects at low doses — mostly developmental and reproductive abnormalities.

NTP concluded bisphenol-A is of "some concern" — a qualitative designation. Other options available to the panel included "serious concern" and "concern" for riskier substances, and "minimal concern" and "negligible concern" for less risky substances.

But FDA, which, unlike NTP, has the authority to regulate the chemical, isn't so sure. FDA has said on past occasions that BPA does not pose a "safety concern at the current exposure level."

A renewed effort within the agency to study BPA is a wise move, as is the decision to seek review from the agency's independent science advisors. FDA says its agency investigation will consult the NTP report as well as "available information on BPA in numerous other risk assessment documents from scientific and regulatory bodies worldwide."

Let's hope FDA keeps its pledge to limit its search to work from "scientific and regulatory bodies." In the past, FDA has relied on industry studies, according to congressional investigators. The House Energy and Commerce Committee wrote to FDA in January asking the agency to identify the basis on which it has made its decision that BPA is not harmful. FDA identified two studies, both of which were funded by the American Chemistry Council. One study had never been published or subjected to peer review.

Reg•Watch Update: "FDA Would Regulate BPA If Found Harmful, Official Says"

Another story on preemption — a hot issue this week (see here and here for previous posts) — brought to you by the Food and Drug Administration (FDA).

Last week, FDA proposed new rules on drug labeling that aim to better convey potential risks to pregnant women and their fetuses and breast-feeding mothers and their newborns. The rule would eliminate the current risk communication design for pregnancy and lactation labeling, which FDA says could potentially be misleading, and would replace it with brief and straightforward risk characterizations.

Based on a reading of FDA's summary of the proposed rule, it seems to be above board and beneficial. "A number of doctors said they believed the new labeling would be a boon for pregnant and lactating women, many of whom take multiple prescriptions," according to ABC News.

But the rule also includes an unfortunate caveat. The rule would preempt tort lawsuits, brought as a failure-to-warn claim, at the state level. In other words, if a mother or child were harmed by a drug, the rule would legally prohibit them from seeking damages from the drug maker, so long as that company abides by the regulation.

The preemption language is actually reaffirmation of a policy FDA finalized in January 2006. That rule applied the preemption theory to the labeling for all prescription drugs. FDA's decision to include preemption in this rule proves just how callous the Bush administration is when it comes to protecting the legal rights and ensuring the health of U.S. citizens: even pregnant women, fetuses, new mothers, and new babies are fair game. All to the benefit of special interests, of course.

FDA's decision to protect drug makers from damages claims is problematic for a number of reasons. In an article for the American Constitution Society, Georgetown law professor David Vladeck argues preemption in this arena "would undermine the incentives drug manufacturers have to change labeling unilaterally to respond to newly-discovered risks, or to seek labeling changes from the FDA." He goes on, "Drug manufacturers have significant authority — and indeed a responsibility — to modify labeling when hazards emerge and may do so without securing the FDA's prior approval."

Vladeck also argues, "[S]tate damages litigation helps uncover and assess risks that are not apparent to the agency during a drug's approval process, and this 'feedback loop' enables the agency to better do its job."

FDA published the rule on May 29 — just in the nick of time to meet a White House imposed deadline on new regulations intended for completion during the Bush presidency. The rule is open for public comment until August 27.

The Project on Scientific Knowledge and Public Policy at the George Washington University is looking for government scientists to participate in a project which will allow for better understanding of how science is used in policymaking and how the process can be improved:

Scientists in Government is a two-year project whose goal is to promote and shape the public discussion about the rights and responsibilities of government scientists, as part of the larger effort to ensure that government uses the best science to protect and promote the health and well-being of Americans. In order to achieve this goal, we will collect and analyze data on the role and functioning of scientists employed by government agencies; produce a series of reports and policy proposals for future policymakers and government leaders; and communicate the findings and proposals in a manner that facilitates their use by policymakers.

Click here for more information.

Click here if you are a scientists willing to participate.

Yesterday, Reg•Watch blogged about five environmental groups that are suing the Environmental Protection Agency over its new national air quality standards for ozone, or smog.

Turns out, pretty much everyone is happy with the new EPA rules. In addition to the environmental groups, 14 states announced they will sue EPA hoping for a standard even more protective of public health than the one EPA adopted.

One state, Mississippi, is also suing but is doing so in order to weaken the standard. A coalition of industry groups, including the National Association of Manufacturers, is also suing. According to BNA news service (subscription), "The Mississippi and industry lawsuits will likely challenge EPA's scientific underpinnings for setting the ozone standards, including how background ozone levels were modeled and how scientific studies were interpreted, one industry attorney familiar with the cases, but who asked not to be named, told BNA May 28 ."

Those suing in favor of a more protective standard will likely argue that the body of scientific evidence supports a stricter rule and will cite the Clean Air Act's clear directive that EPA protect the public within an "adequate margin of safety."

According to an EPA analysis, the new standard will prevent at least 260 premature deaths, 890 heart attacks, and 200,000 missed school days every year starting in 2020. Had EPA adopted a standard at the weakest end of the range recommended by its scientific advisors, an additional 300 premature deaths, 610 heart attacks, and 440,000 missed school days could be prevented every year.

The 14 states are New York, California, Connecticut, Delaware, Illinois, Massachusetts, Maryland, Maine, New Hampshire, New Jersey, New Mexico, Oregon, Pennsylvania and Rhode Island. The city of New York and Washington D.C. also joined the suit.

Yesterday, five environmental groups announced they will file suit against the Environmental Protection Agency over its recent revision to the national air quality standard for ozone, or smog.

Although EPA tightened the public health standard, also known as the primary standard, for ozone to 0.075 parts per million (ppm), down from 0.084 ppm, the agency did not go as far as its scientific advisors had recommended. EPA's Clean Air Science Advisory Committee recommended the standard be set somewhere between 0.060 ppm and 0.070 ppm. Other advisory committees and countless independent scientists also recommended a standard lower than the one adopted.

Because the Clean Air Act requires EPA to set the standard for ozone based solely on the best scientific evidence available, the decision to set the standard outside the recommended range puts the standard on shaky legal footing.

The public welfare standard, also known as the secondary standard, is on even shakier footing. EPA decided to set the secondary standard identical to the primary standard, instead of adopting a separate standard tailored for the summer months when ozone levels are at their highest.

The problem is, both EPA scientists, policymakers, and administrator Stephen Johnson wanted the summer standard because science shows that sensitive trees and plants could benefit. The White House Office of Management and Budget disagreed, and President Bush was brought in to arbitrate the dispute. Bush ultimately came down on the side of OMB.

Bush and OMB paid no mind to the Clean Air Act, which requires EPA set a standard to protect public welfare if necessary and which invests in the EPA administrator, not the president, the power to make clean air decisions. (More on that here.)

If the courts tell EPA they need to set a separate secondary standard, the decision will be a stinging rebuke to Bush's intervention and a forewarning to future presidents. We don't know why the White House opposed a separate secondary standard. Maybe it was funneling the concerns of industry. Maybe it was exercising its ideological opposition to environmental regulation. Maybe neither. Maybe both.

Regardless of the rationale, a decision in favor of a separate standard will send a clear message for this and other rulemakings: A president's personal views do not trump the plain language of federal law.

The organizations filing the suit are the American Lung Association, Natural Resources Defense Council, Environmental Defense Fund, National Parks Conservation Association, and Appalachian Mountain Club. They will be represented by Earthjustice, a nonprofit, environmental law firm.

Yesterday, the Senate passed an amendment to the war supplemental bill that will put the brakes on several controversial Medicaid regulations. The Bush administration has finalized, or is preparing to finalize, the regulations in an effort to cut federal funding for a variety of Medicaid programs administered by the states. (More details on the regulations here.)

The administration developed the regulations under the guise of "fiscal integrity," arguing state Medicaid programs are using loopholes to inappropriately claim federal funds. Bush has threatened to veto the bill. Fortunately, the amendment passed the Senate in a 75-22 vote and also cleared the House by a veto-proof margin.

On May 6, more than 100 hospitals, providers, school districts and public interest groups (including OMB Watch) wrote to Congress in support of the legislation, which will place moratoria on all seven of the regulations until April 1, 2009. The letter says, "Taken together, the impact of these regulations would undermine the viability of our nation's health care safety net and reduce or eliminate access to health care services for many millions of low income patients."

Critics also question the administration's authority to make such major changes to Medicaid. For example, one of the proposed rules would limit the ability of state governments to provide rehabilitation services (such as transitions to independent housing) for people with mental illnesses or developmental disabilities. The Bush administration floated this limitation as a legislative proposal in 2006, but Congress rejected it.

Kudos to members in both chambers voting yea: they stood up to the administration's efforts to hobble state Medicaid programs.

From a government operations standpoint, Congress should also be commended for reestablishing control over issues that are properly within its purview and rebuking the administration's efforts to reinterpret federal law through administrative means.

Posted by Matt Madia, 12:00:40 PM

Wednesday, May 21, 2008