Food Safety for 2010: the Good, the Bad … and the Ugly

By James J. Gormley  
courtesy of NOW Foods
In October, we alerted you to serious worries about Senate Bill (S.) 510. Now that we have just started the New Year, let’s take a look back at the whole food safety picture in 2009 and how things are shaping up for 2010.

Here’s a partial run-down on some of the biggest food safety news stories of 2009:

1. Starting in January 2009, a giant peanut manufacturing corporation began voluntary recalls of up to 3,918 products made with peanut butter and peanut paste that reportedly caused nine deaths and 714 confirmed cases of Salmonella in 46 states.
2. In June and July of 2009, a fast-food restaurant in Milan, Illinois had two workers infected with hepatitis A working at the eatery; in addition to workers and customers getting sick, 10,000 people were exposed by the time the situation was under control.
3. Beginning in July (going through December), two mammoth meat manufacturers (based in Denver, Colo. and Fresno, Calif.) recalled 1.314 million pounds of beef due to concerns that it was contaminated with three strains of antibiotic-resistant Salmonella.
4. On September 1st, the Washington Post alerted us to the case of a Nevadan woman severely injured by chocolate-chip cookie dough contaminated with E. coli 0157:H7.
5. On October 4th the New York Times’ Michael Moss reported that a children’s dance instructor from Minnesota was partially paralyzed from E. coli 0157:H7 in hamburgers she ate. The meat originated in massive slaughterhouses in Nebraska, Texas, Uruguay, and a South Dakota firm that treats fat trimmings with ammonia to kill bacteria.
6. In December 2009, a series of articles in USA Today uncovered that Jack in the Box, Burger King and Costco are “are far more rigorous”─up to 10 times more stringent─ in checking for dangerous bacteria than is the USDA in setting standards for beef served to our children via the National School Lunch Program.

And lest these cases create the impression that contamination only relates to beef or peanut butter, ConsumerReports.org posted “The 10 riskiest foods overseen by the FDA,”  which lists the top ten offending foods. In decreasing order of “riskiness,” the article listed (somewhat surprisingly) the following 10 foods and food products: leafy greens; eggs; tuna; oysters; potatoes; cheese; ice cream; tomatoes; sprouts; and berries.

What do 2009’s food-safety outbreaks mean to us?
What the outbreaks in 2009 (and, for that matter over the last 19 years) mean is this: Food production by gargantuan factories and slaughterhouses is questionable; one marked by potentially unsanitary practices and stopgap remedial treatments that don’t work well .

As to food safety bills on Capitol Hill, here’s where things stand as of this writing:

• H.R. 759, or the Food and Drug Administration Globalization Act of 2009, sponsored by Congressman John Dingell (Mich.); 10 co-sponsors; introduced January 28th, 2009; referred to House Committee on Energy and Commerce on January 29, 2009.
• H.R. 875, or the Food Safety Modernization Act of 2009, sponsored by Congresswoman Rosa DeLauro (Conn.); 40 co-sponsors; introduced February 4th, 2009; referred to House Subcommittee on Livestock, Dairy and Poultry on April 23rd, 2009.
• H.R. 1332, or the Safe Food Enforcement, Assessment, Standards, and Targeting (FEAST) Act of 2009, sponsored by Congressman Jim Costa (Calif.); 30 co-sponsors; introduced March 5, 2009; executive comment requested from the FDA and the USDA on April 23rd, 2009.
• H.R. 2749, or the Food Safety Enhancement Act of 2009, sponsored by Congressman John Dingell; 5 co-sponsors; passed under suspended rules on July 30, 2009.
• Senate Bill (S.) 510, or the FDA Food Safety Modernization Act, sponsored by Senator Richard Durbin (Ill.); 15 co-sponsors; placed on Senate Legislative Calendar under General Orders (No. 247).

There are a couple of issues in these bills that stand out like sore thumbs. As to H.R. 875, this bill calls for the creation of yet another agency with another “czar”, the Food Safety Administration; not a welcome addition to fans of limited or more efficient government.

As to H.R. 2749, which passed the House already, this column has previously noted problems associated with this bill, including registration fees for food facilities and powers to “restrict the movement of food” by effectively quarantining (i.e., shutting down) a town, city or region. These aggressive new police powers should be reserved for demonstrable risks to public safety, not given freely as a blanket trust and authority granted to unelected agency bureaucrats.

On the positive side, thanks to grassroots advocacy organization new language in S. 510 exempts safe dietary supplements and organics while softening language relating to the threat of harmonization with Codex Alimentarius; however, there are still some areas of concern.

What will be the legislative fate of these bills?
Since H.R. 759 is considered the flagship House food-safety bill by Congresswoman DeLauro (who is the sponsor of H.R. 875, above) and since Congressman Dingell is the sponsor of H.R. 759 and of the House Bill which was last introduced but which passed first, I foresee two scenarios.

One strong probability is that all of the other House food-safety bills will fall by the wayside, since H.R. 2749 already passed and since S. 510 is likely to pass in the full Senate this year or early next.

A second possibility is that portions of H.R. 875 and 1332 will either make it into negotiations on the Senate side for S. 510─not very likely since H.R. 2749 has already passed─ or will be incorporated into this year’s agriculture appropriations bill, more likely since Congresswoman DeLauro was the sponsor of the 2009 “agriculture bill” that passed in October 2009.

Gormley Take-Away: Senate Bill 510 will likely be the “last man standing” in terms of food-safety bills in the remainder of this current 111th legislative session of Congress─ and perhaps in the first half of next year’s 112th session─and we do need to be vigilant on this bill before it becomes law.   Nevertheless, regardless of whatever food-safety bills are introduced or debated in 2010, we must push for increasing support of local food production (including food co-ops and community supported agriculture [CSA]). We also need food manufacturers to take more responsibility for ensuring the safety of the foods they produce by the use and enforcement of existing audited GMP and HACCP systems, backed up by testing. This will continue to keep the public safe and prevent Congress from setting up overly broad enforcement mechanisms without fixing the underlying problems.

Senate Bill 510: The $825 Million Dollar Folly

By James J. Gormley

courtesy of NOW Foods

Are you a backyard grower of heirloom tomatoes you sell on your own property or at a local farmer’s market? If so, you will be in for a whopper of a surprise if Senator Durbin’s Senate Bill 510 (S.B. 510) passes: you may be receiving a visit from inspectors.

Products not grown according to designated standards will be considered adulterated and your business records will be subject to warrantless searches by inspectors from the U.S. Food and Drug Administration (FDA), all this without any evidence that you have violated any law.

Wonder why the National Guard or Federal agents have effectively imposed martial law by quarantining your town? Under S.B. 510’s House counterpart bill, H.R. 2749 (Section 133b, “Authority to Prohibit or Restrict the Movement of Food”), sponsored by Congressman Dingell, the Secretary of Health and Human Services will have the power to prohibit all movement of all food within a geographic area, whether the food is in your grandmother’s grocery bag in her Toyota Hybrid or on a flatbed. No court order will be needed, just a phone call to the appropriate state official and a public announcement will be sufficient.

Upset that raw milk or raw milk cheeses (like feta) are no longer available in the U.S.? This could well happen thanks to the “performance standards” powers that would be granted to the FDA by S.B. 510, especially since the agency has made it clear that it is vehemently opposed to the consumption of raw milk products.

Amazed that U.S. food safety regulations strangely match those of other countries? Well, Section 306 of S.B. 510 would require “Recommendations to harmonize requirements under the Codex Alimentarius.”

And what about food supplement manufacturers, suppliers, distributors and health food stores? Will they be ensnared in this bill’s draconian, 1984-esque net? Very possibly so.

This all may seem far-fetched, but theoretically, this new law would give the government all this authority.

S.B. 510 (which would cost Americans $825 million in 2010 alone) and the House of Representatives version of this bill, H.R. 2749, which did pass under suspended rules, do not address the root causes of the U.S.'s food safety problems, which were highlighted in both a recent campaign by the Farm-to-Consumer Legal Defense Fund (FTCLDF) and by a letter to 99 U.S. senators by the Ranchers-Cattlemen Action Legal Fund (R-CALF USA).

According to Citizens for Health (http://www.citizens.org/), if this proposed law is enacted it would:

• Undermine DSHEA and move the U.S. one step closer to harmonizing our standards under Codex with those of supplement-restrictive regimes like the European Union. (DSHEA, or the Dietary Supplement Health and Education Act, asserts that supplements are food and are safe for consumption unless proven otherwise – ensuring that millions of Americans are able to enjoy access to safe, effective and affordable dietary supplements).

• Give the FDA unprecedented control over farms and direct-to-consumer distributors. If passed, the bills would charge facilities an annual $500 registration fee, require additional record keeping, and expand FDA authority to quarantine geographic areas for alleged food safety problems – all without significantly improving food safety.

• Cost U.S. taxpayers billions of dollars ($825 million in 2010 alone) while providing fewer physical inspections and less food safety overall.

• Harm U.S. organic farmers by imposing overlapping regulations.

• Hurt food supplements and health-food stores by imposing standards that are already covered by the AER (Adverse Event Reporting) Law, cGMPs (current Good Manufacturing Practices) and food facility registration.

• Cripple local food co-ops, farm stands, independent ranchers and artisanal food producers by imposing unnecessary standards and unfair bureaucratic burdens.

Clearly, S. 510, while purporting to increase food safety would actually leave consumers more vulnerable to foodborne disease since the FDA would be required to use a risky, risk-based food safety system rather than doing old-fashioned, effective physical, on-site inspections in plants, factory farms and slaughterhouses, where the actual food safety concerns are.

Furthermore, the U.S. has abrogated its duty to inspect and enforce food safety standards, both here and abroad, by allowing processing plants to regulate themselves under a failed system; and it has embraced policies that have driven independent U.S. farmers and ranchers out of business and replaced them with corporate-owned, industrialized food production units that are known to cut food safety corners to maximize corporate profits.

So what do we need to do?

Click here for an opportunity to send a letter opposing S.B. 510 as it is currently written.

Gormley Take Away: As of this writing, our nation is over $11.8 trillion in debt. Let’s not add $825 million more (actually several trillion dollar over the next few years) for a bureaucratic monster to be foisted upon an already deeply flawed U.S. food-safety system. S.B. 510 is sadly, and ironically, not about food safety, although I wish it were. It’s about food madness, pure and simple, and it must be fixed … or stopped.

Lawmaking and the GAO Report: A Dose of Reality

By James J. Gormley

At the end of 2007, the U.S. dietary supplement industry recorded sales of $23.7 billion, according to Nutrition Business Journal. With roughly 33,000 dietary supplements on the U.S. market, it’s no surprise that with today’s nutritionally challenged diet there were 192 million Americans using supplements in 2007, a number that is expected to keep growing.

In addition to wanting to provide a basic nutritional “insurance policy” offered by a multivitamin, people take nutritional supplements for a variety of health-promoting reasons. In a 2000 survey conducted by Yankelovich Partners and commissioned by the Natural Products Association (NPA), seven out of 10 Americans take supplements because they make them feel better.

With the December 22nd, 2006, enactment of the Dietary Supplement and Nonprescription Drug Consumer Protection Act (often called the Serious Adverse Event Reporting [SAER] Law) and the August 24, 2007 implementation of the final rule on Current Good Manufacturing Practices (often called the cGMPs of federal GMPs, 21 CFR Part 111) — along with complementary and innovative industry self-regulatory programs—consumers have arguably never been better protected.

Not so, says a new report from the U.S. Government Accountability Office (GAO), entitled Dietary Supplements: FDA Should Take Further Actions to Improve Oversight and Consumer Understanding.

Broadly, the GAO report recommends: “…that the Secretary of Health and Human Services direct the Commissioner of the FDA to request additional authority to oversee dietary supplements, issue guidance on new dietary ingredients and to clarify the boundary between dietary supplements and foods with added dietary ingredients, and take steps to improve consumer understanding of dietary supplements.”

“I am troubled that the FDA lacks the basic information necessary to protect consumers from unsafe dietary supplements […] The FDA clearly needs more resources to give consumers real protection,” announced Rep. Henry A. Waxman (D-CA) upon release of the report.

His colleague, Rep. John D. Dingell (D-MI), added: “FDA needs the resources and adequate authorities [sic] so the agency can start addressing this problem.”

Among the report’s many conclusions, the GAO notably recommends that the Secretary of the Department of Health and Human Services (HHS) “direct[s] the [FDA] Commissioner” to require dietary supplement companies to “report all adverse events related to dietary supplements.”

The SAER Law already well protects consumers and has already demonstrated its ability to provide a signal to the FDA for action. The number of serious adverse event reports is in the hundreds, as compared to the hundreds of thousands of deaths and millions of serious adverse events for drugs and foods.

Why then would the GAO report require the reporting of all dietary supplement adverse events when this is not required for foods or drugs? This simply does not make any sense.

On top of this, the FDA itself doesn’t even think this makes sense. In its response to the report, the FDA wrote: “[…] it is not clear that all the information would actually enhance product safety.”

Finally, to top it off, did you know that the GAO, in fact, works for Congress? The head of GAO, the Comptroller General of the United States, is appointed to a 15-year term by the President from a slate of candidates Congress proposes, so clearly its reports are developed to provide support for agenda-driven “requests” from Senators and members of Congress, including the ones who requested this report. Ergo, it’s not always, or necessarily, the independent watchdog it’s often thought to be.

Gormley Take-Away: Lawmakers grandstanding and the GAO report notwithstanding, dietary supplements are by far much safer than foods and drugs. What happened to the facts?

The FDA: A Dose of Reality

By James J. Gormley

At the end of 2007, the U.S. dietary supplement industry recorded sales of $23.7 billion, according to Nutrition Business Journal. With roughly 33,000 dietary supplements on the U.S. market, it’s no surprise that with today’s nutritionally bankrupt diet there were 192 million Americans using supplements in 2007, a number that is expected to keep growing.

In addition to wanting to provide a basic nutritional “insurance policy” offered by a multivitamin, people take nutritional supplements for a variety of health-promoting reasons. In a 2000 survey conducted by Yankelovich Partners and commissioned by the Natural Products Association (NPA), seven out of 10 Americans take supplements because they make them feel better.

With the December 22nd, 2006, enactment of the Dietary Supplement and Nonprescription Drug Consumer Protection Act (often called the Serious Adverse Event Reporting [SAER] Law) and the August 24, 2007 implementation of the final rule on Current Good Manufacturing Practices (often called the cGMPs of federal GMPs, 21 CFR Part 111) --- along with complementary and innovative industry self-regulatory programs --- consumers have arguably never been better protected.

Not so, says a new report from the U.S. Government Accountability Office (GAO), entitled Dietary Supplements: FDA Should Take Further Actions to Improve Oversight and Consumer Understanding.

Broadly, the GAO report recommends (emphasis mine): “…that the Secretary of Health and Human Services direct the Commissioner of the FDA to request additional authority to oversee dietary supplements, issue guidance on new dietary ingredients and to clarify the boundary between dietary supplements and foods with added dietary ingredients, and take steps to improve consumer understanding of dietary supplements.”

“I am troubled that the FDA lacks the basic information necessary to protect consumers from unsafe dietary supplements […] The FDA clearly needs more resources to give consumers real protection,” announced Rep. Henry A. Waxman (D-CA) upon release of the report.

His colleague, Rep. John D. Dingell (D-MI), added: “FDA needs the resources and adequate authorities [sic] so the agency can start addressing this problem.”

Among many recommendations, the GAO notably recommends that the Secretary of the Department of Health and Human Services (HHS) “direct[s] the [FDA] Commissioner” to require dietary supplement companies to “report all adverse events related to dietary supplements.” Aside from the fact that the number of adverse events directly attributed to dietary supplements would be trivial, in general, especially when compared to prescription and non-prescription drugs, the SAER Law already well protects consumers.

On top of this, the FDA doesn’t even think this makes sense. In its response to the report, the FDA wrote: “[…] it is not clear that all the information would actually enhance product safety.”

What I would argue is that why should America give more power and more money to an agency that is ill-equipped to handle, and undeserving of, either?

Here is a brief snapshot of an agency that is in chaos, completely mismanaged and rife with corruption:

• On September 20th, 2006, Sen. Chuck Grassley (R-IA)’s “oversight of the drug-safety agency” “exposed a “too-cozy relationship with the pharmaceutical drug industry and an agency culture that has sought to suppress concerns of agency scientists about drug safety reforms.” Grassley’s demand to the FDA pointed to violations of the public trust, including: “FDA’s suppression of scientific dissent and pressure to alter or exclude [negative] information” relating to drug approvals.

• On October 17th, 2006, the U.S. federal court (Case Number 06-438M) charged a now former FDA commissioner with conflict of interest and related offenses relating to undisclosed pharma connections.

• In November 2007, the Subcommittee on Science and Technology issued a damning report on the FDA entitled FDA Science and Mission at Risk. The report concluded, in part:
a. FDA’s evaluation methods have remained largely unchanged for the last half century.
b. FDA’s scientific workforce does not have sufficient capacity or capability.
c. The FDA has demonstrated a consistent inability to implement needed changes.
d. The recommendations of reviews of the FDA are seldom followed.

• Congressman Dingell --- a leading voice now demanding more resources for FDA --- back on November 17th, 2008, charged the agency with “mismanagement of agency resources” and launched an investigation into the “integrity of the Food and Drug Administration.”

• According to the non-profit group, the Project on Government Oversight (POGO) on February 18th, 2009, “Since 2006, the FDA is not ensuring that medical devices such as defibrillators, pacemakers, replacement heart valves and coronary stents are being tested according to good laboratory practices (GLPs).”

Fortunately, a number of far-sighted consumer organizations want to improve the FDA from its foundations, such as the American Association for Health Freedom, which is leading a campaign to reform the troubled agency.

Gormley Take-Away: Despite the grandstanding consumer-safety posturing from certain lawmakers suggesting that consumers are not protected from supplements, what we all desperately need protecting from is the FDA, itself, which, in its current state, is powerful, unresponsive, political, inept and corrupt. Should we perhaps establish an agency to shield us from the FDA? Better yet, let’s completely reform the agency from the bottom up, but let’s not give more power to an agency that already has more than it deserves to wield or give more resources to FDA until it proves it has (1) eliminated corruption and (2) knows how to better manage the resources (and authority) it already has.