The FDA and the CDC have identified a source of the salmonella outbreak that has sickened more than 1,000 since April, according to The Washington Post:

Investigators discovered the Salmonella saintpaul strain in irrigation water and serrano peppers on a farm in Mexico, where jalapeno peppers are also grown…

The Food and Drug Administration, which earlier issued a warning about jalapeno peppers, is now warning consumers also to avoid raw serrano peppers grown and packed in Mexico.

FDA had initially linked the massive outbreak to tomatoes and issued a nationwide warning against the consumption of certain types of tomatoes. Then, the list of risky produce grew to include jalapeno peppers. Now, it turns out serrano peppers are to blame.

But serranos may not be the only culprit. The Post reports that officials "still believe tomatoes could have been involved as well, even though they have not found a contaminated tomato."

So the investigation will continue, but at least consumers have regained a modicum of confidence that their food safety system can come up with results.

As the investigation winds down and the salmonella story fades from the headlines, let's hope the experience does not similarly fade from the memories of food safety officials and the food industry.

The salmonella outbreak has made clear that American consumers need a robust food tracking system. One of the subplots of this story has been the revelation that the food industry lobbied the Bush administration in 2003 and 2004 while regulators were developing a congressionally-mandated food traceability regime.

The product of that cozy relationship, a feckless tracking system, caused some major headaches for both federal officials and the food industry. FDA was the subject of much criticism for its handling of the situation, even though investigators on the ground were probably working as diligently as they could with the resources they had.

But criticism aimed at FDA higher-ups was warranted, since the salmonella crisis was at least partly preventable. According to the Associated Press, "Tommy Thompson, who was health secretary during the industry's lobbying campaign, acknowledged that a more robust food-tracking system — opposed by business groups as too expensive — could have helped stem the current illnesses and business losses."

And those business losses were pretty serious. Representatives from the tomato industry estimate they lost hundreds of millions of dollars as a result of the outbreak. The Bush administration and industry lobbyists should both remember this lesson the next time the door closes and the backroom negotiations over federal policy begin.

After a protracted House/Senate negotiating period, Democratic and Republican leaders came to an agreement on several controversial provisions in a bill to improve consumer product safety. Early reports indicate that negotiators came down on the side of public health on most or all of the issues that had proved difficult to hash out. CQ.com reports:

While the final provisions have not been released, advocates and lobbyists say there will be language to protect whistleblowers, make toy safety standards mandatory, regulate manufacturing of all-terrain vehicles and give state attorneys general certain decision-making powers….

One of the most controversial provisions in the Senate's bill, a restriction on phthalates — a plastic softener some believe can damage reproductive development — made it into the agreement in modified form.

According to House aides, the deal would ban three of the six suspect phthalates outright, for all children's toys. The other three phthalates would be banned temporarily in products that could be put into a child's mouth, pending further study and rulemaking.

The news on phthalates — that a ban would be enacted pending further study and would only end if the substances' safety is proven — is a radical departure from the way the federal government generally regulates chemicals. Usually, chemicals are released into the market and used without restriction. If initial toxicity studies show a potential health risk exists, researchers inside federal agencies may take a more in-depth look. If research shows a health risk exists (and overcome the often-specious claims from the anti-government crowd that more certainty is needed), all that's left is navigating the labyrinth of rulemaking requirements agencies must go through before an exposure standard or ban can take effect.

The safety-first approach embodied in Congress's phthalate ban would protect public health in the interim without condemning the substances to an eternal regulatory graveyard. The interim ban shifts the burden of proof onto phthalate manufacturers and users. If the safety of phthalates is proven, they're back on the market.

Congress's action on phthalates is a refreshing take on public health. As consumers, we are exposed to scads of chemicals every day. For many of these chemicals, some studies indicate a risk to public health, but more research is needed before we can paint an accurate portrait of how much of the substances we're exposed to and what they do in the human body.

The presumption that chemicals should be safe would reduce consumer exposure. It would also have the added bonus of creating a market incentive for quick, accurate completion of toxicity studies. Moreover, accurate, transparent scientific findings would provide consumers with a tool for making buying decisions they believe to be in their best interest. Sounds pretty logical, doesn't it?

The Washington Post has obtained a copy of the mysterious Department of Labor risk assessment rule that has been the subject of much speculation over the past couple weeks (see this post for more). The rule would require the Occupational Safety and Health Administration and the Mine Safety and Health Administration to conduct their risk assessments for occupational health hazards in certain ways. Based on an initial reading, Reg•Watch sees four main problems:

The first two flaws reek of those contained in a White House Office of Management and Budget proposal on risk assessment released in 2006 which was subsequently criticized by the National Academies of Science and later withdrawn. First, the rule would require the subagencies to identify a central risk estimate. A central risk estimate takes the high end and the low end of a risk prediction and averages them.

That would mark a departure from current practice in which the agencies identify the maximum likelihood a risk will threaten worker health. This allows OSHA and MSHA to error on the side of caution, which federal law requires them to do. The maligned OMB risk assessment proposal also advocated for central risk estimates, but the NAS criticized the approach.

Second, the rule would require OSHA and MSHA to attempt to quantify the uncertainty in their risk assessments. Scientific studies like risk assessments can never be 100 percent certain, and the constant evolution of scientific knowledge makes the quest to erase uncertainty a futile one. The OMB proposal also urged agencies to quantify the level of uncertainty in their studies. While NAS acknowledged the attempt to quantify uncertainty is common and advancing in its sophistication, it questioned its usefulness to decision makers.

The last two flaws are interrelated. The rule would add a new step to the standard-setting process for occupational health rules. OSHA and MSHA will now have to publish an Advanced Notice of Proposed Rulemaking before they can publish a Notice of Proposed Rulemaking. The ANPRMs will solicit public opinion on the risk assessments the agencies prepare in advance of setting health standards. While public opinion is a good thing, the ANPRM-requirement will add an extra step to the occupational standard-setting process (a process that's plenty long as it is).

Finally, the new rule would force OSHA and MSHA to alter their assumptions when attempting to calculate risk. The subagencies would have to use the ANPRM to ask industry for data on how long workers stay in their jobs. Currently, the agencies assume a work-life of 45 years in order to assure maximum protection for those workers who are subject to a given risk for the longest period of time. Under the rule, the agencies would have to develop a new work-life statistic for individual industries, further complicating and slowing the rulemaking process. Furthermore, if the agencies assume a shorter work-life in their risk assessments, the subsequent health standards may be weakened and not fully-protective of long-term workers.

Senior political officials in the Department of Labor and their friends in OMB are attempting to rush through this regulation before President Bush leaves office. The draft version obtained by The Post is currently under review at OMB's Office of Information and Regulatory Affairs. No word yet on when the Labor Department will propose the rule (or maybe officials will try to go directly to the final rule stage). Rep. George Miller (D-CA) has pledged to introduce legislation that would stop the rule from taking effect. Stay tuned to Reg•Watch for updates or email us with your thoughts on the rule.

The Senate missed an opportunity this week to beat back a Bush administration policy that will keep low-income kids from receiving government insurance.

In August 2007, the Centers for Medicare and Medicaid Services (CMS) announced a policy, to take effect this August, which will make it more difficult for uninsured kids to qualify for the State Children's Health Insurance Program (SCHIP). For example, New York state wants to set its eligibility limit at 250 percent of the poverty level. While that may sound like a lot, it's only about $44,000 for a family of three. Unfortunately, CMS thinks those folks are too wealthy to qualify.

Sens. Max Baucus (D-MT) and John Rockefeller (D-WV) are trying to stop the policy by using a little-known law called the Congressional Review Act which allows Congress to disapprove of agency regulations.

But the Senate has run into a bit of a sticky wicket. CMS did not release the policy as a formal rule; rather, they issued it as a guidance document — a less formal class of government policy that is not subject to Congressional Review Act challenges.

On April 17, 2008, the Government Accountability Office said that the CMS guidance document should be considered a rule for the purposes of the Congressional Review Act. So that means Congress can challenge the rule…right?

The problem, it turns out, is timing. Congress only has 60 "session" days to introduce a resolution of disapproval. The 60-day clock starts the day the agency informs Congress of its rule. After GAO's April ruling, CMS sent a letter May 7 saying the agency would ignore GAO, and it refused to submit the policy to Congress as it would a normal rule.

So GAO says the policy is a rule, a decision Baucus and Rockefeller prefer because it means they can file a Congressional Review Act challenge; but CMS says the policy is not a rule and won't submit it to Congress. The question becomes: When does the 60-day clock start?

The Senate parliamentarian sent a letter to Baucus and Rockefeller this week that says the clock started April 17, the day of the GAO ruling. That means the deadline for introducing the resolution was July 8. (Don't bother trying to figure out how the Senate counts days. Nobody knows.) Baucus and Rockefeller introduced the measure on July 17.

The parliamentarian's determination doesn't make much sense — not that any other date would make much sense either. This is uncharted territory for the Congressional Review Act.

But this shouldn't even be an issue. Why did it take Baucus and Rockefeller so long to introduce the resolution? As a result of the parliamentarian's decision, they had to postpone a scheduled markup of the resolution. Now, the Senate will miss out on the expediencies that an official Congressional Review Act challenge carries (limited debate and no filibuster).

Those expediencies could have been valuable, since time is of the essence for low-income families. If Congress can't find another way to nullify the CMS policy by August 17, many deserving kids will be left without insurance.

Details about a mysterious Department of Labor (DOL) rule on occupational health risks are beginning to surface. In today's Washington Post, reporter Carol Leonnig sheds new light on the situation.

The Post obtained an early draft of the rule which Reg•Watch and others have been speculating about for the past couple weeks. The Post's account gives credence to some of the suspicion:

[The rule] would call for reexamining the methods used to measure risks posed by workplace exposure to toxins. The change would address long-standing complaints from businesses that the government overestimates the risk posed by job exposure to chemicals.

The rule would also require the agency to take an extra step before setting new limits on chemicals in the workplace by allowing an additional round of challenges to agency risk assessments.

Including an opportunity for additional challenges is likely an effort to give industry trade groups and the anti-regulatory crowd an opportunity to attack and undermine the science that serves as the basis for occupational health protections.

Critics say the rule is being pushed through under Bush's tenure in order to tie the hands of a future administration. The Post article quotes David Michaels, an expert on public health and industry influence in government science, as saying: "This is a guarantee to keep any more worker safety regulation from ever coming out of OSHA. This is being done in secrecy, to be sprung before President Bush leaves office, to cripple the next administration."

The easy path the rule has taken through the usually daunting regulatory labyrinth raises further suspicion. Leonnig describes several issues which indicate the Bush administration is intentionally hiding its activities on this rule from the public.

First, the rule was not included in the Labor Department's most recent Unified Agenda. The Unified Agenda is a semiannual listing of all the regulatory actions an agency is considering with an identification of their status, i.e. long-term action, proposed rule, or final rule. The Unified Agenda is often the public's first public indication that the federal government is considering some new rule.

Because the last Unified Agenda came out in April, it is possible that an agency could conjure up new regulatory ideas and then propose the action without prior public notification. But, according to the Post article, that's not the case with DOL's risk assessment rule. When DOL published its most recent Unified Agenda, "a draft was circulating among a small group of advisers, according to a date-stamped copy obtained by The Post."

Second, senior officials in DOL are not even tapping into the wealth of occupational health knowledge within the Department. Politicos in DOL did not consult with the Occupational Safety and Health Administration or the Mine Safety and Health Administration, the two agencies responsible for protecting workers and most likely to be affected by revisions to the occupational risk assessment process.

Instead, "Deborah Misir, a political deputy in Labor's office of the assistant secretary for policy, worked with the OMB to draft a new risk-assessment rule," according to The Post. DOL also paid $349,000 to an outside consultant, Diana Furchtgott-Roth of the conservative Hudson Institute, to study the risk assessment process, The Post reports.

Finally, both DOL and OMB are ignoring a recent memo sent by White House Chief of Staff Josh Bolten that instructed agencies to propose by June 1 any regulation they wish to finalize before the end of the Bush administration. Even though the occupational risk assessment rule has yet to be proposed, OMB and DOL are working together to finalize it by year's end, according to The Post.

The White House framed the Bolten memo as a good government measure, but the shenanigans surrounding the DOL rule — and OMB's endorsement of those shenanigans — clearly shoot a hole through that argument. The memo will have no impact on the White House's ongoing regulatory strategy: stifle any regulations it doesn't like, and surreptitiously hustle through those it does.

On Friday, the Environmental Protection Agency finally released its Advanced Notice of Proposed Rulemaking asking for public comment on the issue of greenhouse gas emission regulation. The notice — which is not a formal policy proposal but merely a suggested framework for future action — is accompanied by statements from senior officials from across the Bush administration that disavow the document's substance.

Susan Dudley, head of the White House's regulatory clearinghouse, the Office of Information and Regulatory Affairs, 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.

The ANPRM and the accompanying letters mark the end of a successful campaign, waged primarily by White House officials, to whittle into virtual nothingness any meaningful federal action on greenhouse gas emissions.

After a March 2007 Supreme Court case, Massachusetts v. EPA, found that EPA must regulate greenhouse gas emissions under the Clean Air Act or give good cause as to why it should not, President Bush signed an executive order forming an interagency team to evaluate the case and future regulatory action. EPA Administrator Stephen Johnson promised he would propose a new rule by the end of 2007.

But those promises were merely a mask for the gross deception that was forthcoming. EPA staff spent who-knows-how-many hours preparing a draft proposed rule and an "endangerment finding," a document saying greenhouse gases are detrimental to public welfare. An endangerment finding is a legal trigger for regulatory action under the Clean Air Act.

But acknowledging that global warming poses a danger to society is not this administration's cup of tea; and we know that it has little or no interest in regulations to protect the public.

When EPA sent the documents to OMB for review, OMB officials refused to open the email. Since OMB wouldn't read the documents — the bureaucratic equivalent of sticking your fingers in your ear and yelling, "I can't hear you" — EPA was forced to go back to the drawing board.

Then, in March 2008, Johnson faulted on his earlier promise to propose new federal requirements, instead pledging the agency would publish an Advanced Notice of Proposed Rulemaking to solicit public comment.

But even after White House officials had forced EPA to do as little as possible, they still weren't done meddling with the substance of EPA's work. As the Wall Street Journal recently reported, "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 economic analysis referred to also mysteriously underwent editing that downplayed the economic benefits of regulation, according to The Los Angeles Times:

In a draft of the document completed in May, EPA staff members concluded that regulations reducing greenhouse gas emissions could save $2 trillion through lowered gasoline costs and other benefits over 30 years. In the final document, that figure was slashed more than 50%, to $830 billion. The lower figure is based largely on an estimate that gasoline will cost $2 a gallon over the next three decades, less than half the current price.

Finally, Friday afternoon, the American public received the final slap in the face from the Bush administration which is asking for comments on a document that it does not support, on proposed policy it has no intention of pursuing, and on a problem it is not willing to acknowledge exists.

The New York Times has an article this morning further underscoring the problems the FDA has tracking the sources of food-borne illness outbreaks. The toll of the current salmonella outbreak has exceeded 1,000 victims "in what officials said Wednesday was the largest food-borne outbreak in the last decade."

Initially, tomatoes were thought to be the culprit of the outbreak. FDA then said it was expanding its search to other types of produce but emphasized tomatoes were still the lead suspect. But according to the article, "Federal investigators have now linked at least some of the outbreak to fresh jalapenos."

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 this or any other food-borne illness outbreak a major challenge for FDA. A retailer may buy produce from multiple distributors, each of which likely collects a variety of goods from multiple growers.

However, critics say the FDA itself is at least partially to blame. According to two consumer groups, Center for Science in the Public Interest and the Consumer Federation of America, FDA does not have the necessary safeguards in place to prevent and track food-borne illnesses. Those groups say, "Source traceability for produce, written food safety plans for farmers, processors, and packinghouses, and tighter controls on repacking" are necessary but lacking, despite repeated pleas from food safety advocates.

In the case of the salmonella outbreak, more than a month after the first nationwide warning FDA has been unable to tell consumers what type of produce to watch out for, and it isn't even sure whether the source is foreign or domestic.

Despite the worsening public health crisis and the growing embarrassment for FDA, the agency won't be changing its tune on food tracking. According to the Times article, "Dr. David Acheson, the agency's associate commissioner for foods, said in a telephone interview on Monday that the F.D.A. lacked authority to require full trace-back capability, adding, 'It's the industry's responsibility to put that kind of system in place, not ours.' "

Acheson was promoted at FDA last year to lead its food safety efforts. He started with a "commitment to making the wobbly global food-safety system work better," according to The Washington Post.

But based on his comment that FDA is not responsible for food tracking, Acheson clearly fits in well with the Bush administration's hands-off approach to regulating which leaves consumers fending for themselves. Acheson seems determined to make sure FDA repeats its failures.

The Times article also addresses the issue of whether FDA has the authority to track food through the supply chain:

But Dr. David A. Kessler, the F.D.A. commissioner in the Clinton and first Bush administrations, said the agency has the authority to require the industry to trace produce as it travels from "farm to table," but has lacked "the impetus" to do so.

"The technology exists to trace the entire chain of a food product," Dr. Kessler said. "The agency needs to require the industry to put into effect mechanisms to do full trace-back. That regulation could be put in place in months, not years."

The Pump Handle blog has an interesting post about a new Department of Labor proposal (currently sans description) titled, "Requirements for DOL Agencies' Assessment of Occupational Health Risks."

While that's all we know about the proposal at the moment, the administration has tried in the past to attack the federal government's entire risk assessment process — where the nature and severity of occupational, environmental, consumer, or other risks are scientifically studied and described. That proposal was shot down by the National Academies of Science.

Is this the kind of last minute administrative change the Bush administration will try to push through to secure its legacy? Will other health and safety agencies like EPA or FDA engage in similar practices? Those questions are merely speculation, but stay tuned to Reg•Watch for any developments.

The Pump Handle: "Secret rule on OSHA risk assessment?"

Posted by Matt Madia, 04:49:40 PM

Monday, July 07, 2008

Wednesday, July 02, 2008

Tuesday, July 01, 2008