A Blueprint for Fixing the Food Safety System

The Trust for America's Health and the Robert Wood Johnson Foundation released a report, Keeping America's Food Safe: A Blueprint for Fixing the Food Safety System at the U.S. Department of Health and Human Services, which examines problems with the current system and proposes ways to improve the food safety functions at the U.S. Department of Health and Human Services (HHS) to better protect the nation's food supply.

The report calls for the immediate consolidation of food safety leadership within the Food and Drug Administration (FDA) and ultimately the creation of a separate Food Safety Administration within HHS. Currently, no FDA official whose full-time job is food safety has line authority over all food safety functions.

"FDA certainly needs a modern food safety law and more resources, but to make good use of these tools, HHS needs a unified and elevated management structure for food safety that can implement a science- and risk-based food safety program dedicated to preventing foodborne illness," said Michael R. Taylor, JD, Research Professor of Health Policy at the School of Public Health at The George Washington University and Former Deputy Commissioner for Policy at FDA and Former Administrator of the Food Safety and Inspection Service at the U.S. Department of Agriculture. "Major organizational change requires careful planning and implementation and should not be rushed, but the time is ripe for building sustainable solutions to the problems in our nation's food safety system," he added.

Investigators Find Source of Many Foods Untraceable

From a NY Times story:

Most food manufacturers and distributors cannot identify the suppliers or recipients of their products despite federal rules that require them to do so, federal health investigators have found.

A quarter of the food facilities contacted by investigators as part of the study were not even aware that they were supposed to be able to trace their suppliers, according to a report by Daniel R. Levinson, the inspector general of the Department of Health and Human Services. . . .

Do Fewer Inspections Make Food Safer?

Doug Powell has written a number of blog posts pointing out that inspection don’t make food safety (see the fallacy of food safety inspections.)

Increasing the number of poor inspections will  never improve food safety. However, let’s be careful not to over generalize.  Just ask yourself, “Do fewer inspections make food safer?” 

The past decade has been an American experiment with federal food safety deregulation. The experiment has left Americans with a growing sense of the failure of their government, left the public feeling vulnerable, and intensified calls for reform of our food safety system. Less government oversight and fewer inspections is not working.

I had a great trainer once who challenged me, “Practice does NOT make perfect!  Proper practice makes perfect!”

Inspections do not make food safer.  Proper inspections make food safer.

Posner Dresses Down Prosecutor in Salad Dressing Dispute

Judge Richard Posner blasted a federal prosecutor in an appellate opinion for her repeated “false and misleading” characterization of salad dressing “best when purchased date” as the expiration date, the ABAJournal.com reports. Open criticism of a prosecutor by a judge is rare. Such criticism of a U.S. Department of Justice Attorney is exceedingly rare. Therefore, Judge Posner’s candor is surprising.

The defendant in the case had bought 1.6 million of bottles of Henri's salad dressing and attached new labels that extended "best when purchased by" dates. He was convicted of violating food-labeling laws and wire fraud and was sentenced to five years' probation. However, at trial the prosecutor repeated characterized the “best when purchase date” as an expiration date. The prosecutor also represented the salad dressing as “foul, rancid food,” when the acidic salad dressing apparently had no expiration date and was shelf stable.

The appellate review involved mostly what was not in the record. Posner noted, “the omissions are more interesting than the scanty contents of the government’s threadbare case.” The prosecutor produced no evidence of a health concern, not a single consumer complaint about the taste, and no evidence of product deterioration.

Judge Posner also criticized the testimony of the Food and Drug Administration (FDA) expert witness, as "not just improper and inadmissible but incoherent." The FDA expert apparently testified as to unpublished agency interpretation or guideline. Posner said, “It is a denial of due process of law to convict a person of a crime because he violated some bureaucrat’s secret understanding of the law. ‘The idea of secret laws is repugnant. People cannot comply with laws the existence of which is concealed.’” (Quoting Torres v. INS, 144 F.3d 472, 474 (7th Cir. 1998).

“Misbranded” food under the Federal Food, Drug, and Cosmetic Act (FD&C Act) is an expansive definition. In fact, the definition is so breathtakingly broad I have to work hard to find limitations to talk about in my food law class. However, the FD&C Act definition of misbranded is silent on dates, and unlike some states, FDA has no regulations on “best by” dates. FDA has given me something new to add to my curriculum, United States v. Charles Farinella.

To read more:

Ameet Sachdev, Posner tosses out salad-dressing verdict with unusually stern words for prosecutor, ChicagoTribune.com (Mar. 16, 2009).

Above the Law, Judge Posner Says Expired Salad Dressing is Fine... But Federal Prosecutor Isn't.

California Court of Appeal Affirms that Methylmercury in Tuna is "Naturally Occurring"

Canned tuna is exempt from California’s Proposition 65 for methylmercury, a chemical listed by the state of California as a reproductive toxin and carcinogen, because the methylmercury in tuna is naturally occurring for purposes of Proposition 65.  So confirmed the California Court of Appeals in an opinion by Associate Justice Timothy A. Reardon in The People ex rel. Edmund Brown Jr. v. Tri-Union Seafoods (A116792, filed Mar. 11, 2009)

The tuna company defendants had also argued that federal law preempts Proposition 65 and that the level of methylmercury is below the threshold at which a warning is required; however, the appellate decision did not consider these other grounds. The decision was based solely on the whether the toxin was naturally occurring for purposes of Proposition 65.

Peanut inspection system filled with holes

Alan Ludd, The Atlanta Journal-Constitution (Sunday, March 08, 2009)

“Georgia’s food inspectors had rules for butchering alligators. They had procedures for the proper handling of ‘feral swine.’ But only since last month has the inspectors’ manual told them specifically how to ensure the safe processing of a more everyday fare: peanuts. .  .  .”   The full report is available here.

Trans Fat Ban in Boston

Effective March 12, Boston has banned the use of artificial trans fat in bakeries.  Earlier the Boston Public Health Commission had banned other food-service establishments from using trans fatty acids.  

“There are no health benefits and no level of consumption of artificial trans fat that is considered safe,” said Dr. Barbara Ferrer, executive director of the Public Health Commission. “In fact public health research over the past 20 years has shown that trans fatty acids significantly contribute to heart disease and other health problems.”  From the Boston Public Health Commission Media Release.

Maryland Bill Would Require Warning for Synthetic Food Colorings

Maryland S.B. 101 would require food manufacturers to place a warning label to foods that contain artificial color. This bill would require that, from January 1, 2010 to December 31, 2011, food products that contain specific color additives include the following warning label:

“Warning: The color additives in this food may cause hyperactivity and behavioral problems in some children.”

The labeling requirement also applies to all menus and food advertising notices. Beginning January 1, 2012, the bill prohibits the sale, purchase, use, or selling of food products containing the specified color additives. Violators would be subject to the same penalties as those that apply to adulterated and misbranded foods.

The eight coloring specified in the bill are: FD&C Blue No. 1; FD&C Blue No. 2; FD&C Green No. 3; FD&C Orange B; FD&C Red No. 3; FD&C Red No. 40; FD&C Yellow No. 5; and FD&C Yellow No. 6.

All synthetic food coloring must be approved by the Food and Drug Administration (FDA).  Seven of these colorings are fully approved by FDA as safe for use in foods.  FDA restricts the use of Orange B to casings or surfaces of frankfurters and sausages. (Citrus Red No. 2, which is not included in the bill, is restricted to being used on the skins of oranges not intended for processing.)

In its approval process, the FDA evaluates safety data to ensure that a color additive is safe for its intended purposes. Absolute safety of any substance can never be proven, therefore, FDA’s approval of  colorings and other food additives is made on the best scientific evidence available.  Recent studies (2) have suggested a relationship between artificial colors and hyperactivity in some sensitive children (but not all hyperactive children).  CSPI has petitioned FDA to ban these synthetic colorings.

USDA/APHIS Comment Period for Proposed Rule on Genetically Engineered Organisms

The USDA Animal and Plant Health Inspection Service (APHIS) has asked for comment on its proposal to revise APHIS regulations on the importation, interstate movement, and environmental release of genetically engineered organisms (74 Fed. Reg. 2907 (Jan. 16, 2009)).  APHIS requested comment on the following four issues:

(1) Scope of the regulation and which [Genetically Engineered (“GE”)]  organisms should be regulated;

(2) Incorporation into APHIS regulations of the Plant Protection Act’s noxious weed authority;

(3) Elimination of notification procedure and revision of the permit procedure;

(4) Environmental release permit categories and regulation of GE crops that produce pharmaceutical and industrial compounds.

APHIS is planning for April public meeting(s), but the dates of the meeting(s) are yet to be announced.  APHIS is also extending the comment period for the proposed rule until 60 days after the April meeting(s).

Comments may be sent postal or commercial delivery (two copies) to Docket No. APHIS-2008-0023, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-1238.  Comments may also be submitted on the Federal eRulemaking portal.

NYC Menu Calorie Labeling Requirement Upheld

New York City requires all menu boards and menus in chain restaurants with 15 or more establishments nationally to bear calorie content information for each menu item. The New York State Restaurant Association challenged this regulations, but the Second Circuit Court of Appeals has rejected the challenge both on federal preemption and First Amendment grounds.

The appellate court held that the Nutrition Labeling and Education Act of 1990 (NLEA), “does not regulate nutrition information labeling on restaurant food, and states and localities are free to adopt their own rules. The NLEA, however, does generally regulate nutrition content claims on restaurant foods, and states and localities may only adopt rules that are identical to those provided in the NLEA.”

The court also held the menu labeling requirement does not violate the First Amendment. In support of the purpose of the regulation the court cited in part on FDA’s amicus curiae brief and, “A 2006 FDA-commissioned report concluded that “obesity has become a public health crisis of epidemic proportions.”  The report is The Keystone Forum on Away-from-Home Foods: Opportunities for Preventing Weight Gain and Obesity (2006). The Keystone Report also associated obesity with the consumption of high-calorie meals fast-food meals, the apparent link between obesity and frequent dining out, and the potential benefits of providing diners with calorie information. The court concluded that the purpose and the means used to achieve that purpose were reasonable.

Hat tip to Ricardo Carvajal.

Indiana's Menu Labeling Bill

Indiana House Bill No. 1207 would require food  establishments having 20 or more locations in Indiana to post both calorie and carbohydrate information “in a manner that allows consumers to consider the information when selecting an item or unit of food.”  These establishments would also have to make available to customers the amount of calories, fat, saturated fat, trans fat, cholesterol, sodium, carbohydrates, fiber, sugars, and protein in each food item.  Violations would be punishable by a civil penalty up to $1,000 for each violation per day.

Hat tip to Cassandra A. Soltis.

Food Traceability Bill Introduced in Senate

Sen. Sherrod Brown (D-OH) has introduced S. 425 to establish a national traceability system for all food under the Food and Drug Administration's (FDA) jurisdiction. The legislation is one of several major food safety bills that have been proposed in the new 111th Congress.

Brown's legislation would establish a nationwide tracking system through the FDA. The system would be developed by an advisory committee comprised of consumer advocates, industry leaders, and representatives from FDA and the USDA. The committee would determine which tracking mechanisms such as tracking numbers, electronic bar codes, and federal databases should be employed to protect consumers.

In addition, the bill would give FDA and USDA mandatory recall authority for contaminated meats, fruits, vegetables and other foods.  USDA has jurisdiction over meat and poultry while the FDA has jurisdiction over fruits and vegetables. (Hat tip to NASDA.)

GAO: FDA Needs to Do Better on Dietary Supplements

The Government Accountability Office (GAO) says the FDA should take actions to improve their regulation of dietary supplements.  Although FDA has taken limited steps to identify and act on safety concerns, a number of factors may allow potentially dangerous products on the market. FDA dedicates relatively few resources to dietary supplement oversight,  In addition, FDA ability to remove dietary supplements from the marketplace is hindered because the agency carries the burden proving significant or unreasonable risk.  (With food additives and drugs, the manufacturer has the burden of proving safety before marketing).

Anyone who has read my book will find this report to be old news.  However, the report offers a well written summary of the situation, and the appendices contain interesting information on FDA actions and a comparison chart on foreign country regulation of dietary supplements.

The  full GAO report is available here, and a summary is available here.  Here is the New York Times article.

It’s Organic, but Does That Mean It’s Safer?

By Kim Severson and Andrew Martin, New York Times (Mar. 3, 2009) http://www.nytimes.com/2009/03/04/dining/04cert.html.

Shoppers who think organic food is safer are often surprised to hear that organic certification has nothing to do with food safety. The recent case of peanut plants in Texas and Georgia sending out contaminated peanut butter and ground peanut products hammers this home. The plants held federal organic certification, but also had rat infestations, mold problems, and bird droppings.

Tainted Food Makes Bill Marler Madder than Any Cow

I couldn't resist this cover picture:

The article is available at:http://www.marlerblog.com/uploads/file/MarlerL&P.pdf.