FDA Withdraws Proposals to Ban Antibiotics in Animal Feed

Maryn McKenna wrote in Wired, “News: FDA Won’t Act Against Ag Antibiotic Use,” about the FDA’s withdrawal of two 1977 proposals to withdraw certain approved uses of penicillin and tetracyclines in animal feeds because of the concerns over antibiotic resistant bacteria:

With no notice other than a holiday-eve posting in the Federal Register, the US Food and Drug Administration has reneged on its long-stated intention to compel large-scale agriculture to curb over-use of agricultural antibiotics, which it had planned to do by reversing its approval for putting penicillin and tetracyclines in feed….

FDA represents this move as a change in tactics because the agency lacks the resources to move forward with a regulatory ban. Instead, the FDA is hoping for voluntary reductions in risky uses of antibiotics in animal feed. In the Federal Register posting, the agency states, “FDA is optimistic that its proposed strategy to achieve the judicious use of all medically important antimicrobials, as set out in draft [guidance document], will be successful . . .”  Perhaps after 34 years of failure, a new FDA strategy is needed.

Are Genetically Engineered Foods "Natural"?

A lawsuit claiming misleading advertising, unfair competition, and breach of express warranty has been filed in California against Frito-Lay chips advertised as “All Natural ingredients” while allegedly “made from genetically modified plants and organisms.”  

Gengo v. Frito-Lay N. Am., Inc., No. 11-10322 (U.S. Dist. Ct., C.D. Cal., filed December 14, 2011).

Neal Fortin is the author of Food Regulation: Law, Science, Policy, and Practice, and he is Professor and Director of the Michigan State University Institute for Food Laws and Regulations, where he teaches online courses in Food Regulation in the United States, International Food Law, and Codex Alimentarius. 

Vulnerabilities in FDA’S Oversight of State Food Facility Inspections

Vulnerabilities in FDA’S Oversight of State Food Facility Inspections, an Office of Inspector General (OIG) report released December 2011, identifies significant weaknesses in FDA's oversight of state food inspections on which FDA increasingly relies. In eight States, FDA failed to ensure that the required number of inspections was completed, and FDA paid for many inspections that were incomplete.

In addition, FDA did not ensure that all inspections were properly classified or that all inspection violations were remedied. FDA failed to complete the required number of audits in one-third of the States with inspection contracts (14 of 41 states). Additionally, the audits in 10 States revealed systemic problems that needed to be corrected; however, FDA initiated corrective action in only 4 of these 10 States.

Neal Fortin is the author of Food Regulation: Law, Science, Policy, and Practice, and he is Professor and Director of the Michigan State University Institute for Food Laws and Regulations, where he teaches online courses in Food Regulation in the United States, International Food Law, and Codex Alimentarius. 

GAO Report, FDA: Better Coordination Could Enhance Efforts to Address Economic Adulteration and Protect the Public Health

This Government Accountability Office (GAO) report examines FDA’s approaches to detecting and preventing economic adulteration of food and medical products. The report notes the challenges FDA faces in detecting and preventing such adulteration, but concludes, "FDA may not be making the best use of its scarce resources.” The full report is available here.

Neal Fortin is the author of Food Regulation: Law, Science, Policy, and Practice, and he is Professor and Director of the Michigan State University Institute for Food Laws and Regulations, where he teaches online courses in Food Regulation in the United States, International Food Law, and Codex Alimentarius. 

WTO rules against U.S. country-of-origin labels

According to the Associated Press, the World Trade Organization (WTO) has ruled that U.S. "country-of-origin" labels on cattle and hog exports from Canada and Mexico violate international rules. In late 2009, the WTO opened an investigation into U.S. labeling rules at the request of Canada and Mexico. The country-of-origin labeling regulation took effect in 2008. Canada and Mexico each claimed their livestock industries were hurt by a sharp drop in U.S. cattle and hog imports because the labeling raised the costs and discouraged imports of their produce.

Under country-of-origin labeling, foreign cattle and pigs had to be segregated in U.S. feedlots and packing plants, prompting some firms to deal only with American livestock. Foreign animals also were required to have more documentation about where they came from and, in the case of cattle, had to have tags that indicated they were free of mad-cow disease.

More information is available here.

European Union's Food Information to Consumers Regulation

Since the vote of the European Parliament in July, we have been waiting for the EU Food Information Regulation to be issued in final form. It was published in the Official Journal (L) of the European Union on November 22. The citation is Reg. (EU) 1169/2011. OJ(L) 304/18, 22 Nov 2011.

This Regulation revises 20 years of EP and EC Directives and Regulations. Among the changes, the regulation requires nutrition label declaration of the "Big 7"—energy, fat, saturated fat, carbohydrates, sugars, protein, and salt by Dec. 13, 2016. There are also new rules on allergen labeling and legibility. The regulation introduces a minimum font size of 1.2 mm for all mandatory label information, and 0.9 mm for products whose packaging has a largest surface of less than 80 square cm.

The full text of the Regulation (66 pages), European Union's Food Information to Consumers Regulation, is available at: www.food-label-compliance.com. Hat tip to Charles Woodhouse.

Cooks Lie About Thermometers

Nancy Shute of NPR's Food Blog wrote in Why We Lie About Using Food Thermometers, "Just 20 percent of Americans say they regularly use a food thermometer to make sure they have cooked food safely, according to a new survey . . . And food safety experts say that a fair number of those people were probably fibbing."

          With the holidays coming, this is a good time to buy some good digital thermometers and give them to kith and kin. Some will give you an odd smile, throw it in the back of a drawer, never to see daylight again. Some will be prodded to cook safety, and the life you save could be your own.


          I like the CDN ProAccurate models, in particular the CDN DTQ450X ProAccurate Quick-Read Thermometer. Whatever model you get, look for a fast read, accurate digital thermometer. Take multiple readings. It can be hard to find the coldest point. And make sure the coldest part reaches the temperature recommended by the USDA.

 

FDA Law Blog: New Twist In “Natural” Lawsuit

FDA Law Blog: New Twist In “Natural” Lawsuit by Riëtte van Laack reports on another class action suit regarding “natural” food labeling claims. The defendants include Kashi Co. and its general manager, as well as Kashi’s parent Kellogg Co. and its President. "Plaintiffs claim defendants falsely and misleadingly labeled virtually all Kashi products as 'all natural' or containing nothing artificial even though the products allegedly do not conform to applicable federal regulations and policies on 'natural.'”

Neal Fortin is the author of Food Regulation: Law, Science, Policy, and Practice, and he is Professor and Director of the Michigan State University Institute for Food Laws and Regulations, where he teaches online courses in Food Regulation in the United States, International Food Law, and Codex Alimentarius. 

Nutrition Labeling of Single-Ingredient Meats Coming January 1

The USDA Food Safety Inspection Service (FSIS) published a final rule that will required nutritional labeling on major cuts of single-ingredient raw meat and poultry products and on all ground or chopped meat and poultry products (unless an exemption applies). The rule also establishes criteria for making a lean percentage statement. The new rule takes effect on January 1, 2012. FSIS has published an informational Web site that includes the final rule, questions and answers, and a PowerPoint presentation. 

Public Health Law Research Annual Meeting

Public Health Law Research is holding the 2012 Public Health Law Research Annual Meeting, "Public Health Law: Targets of Opportunity," January 18-20, 2012, in New Orleans. The conference will highlight research that provides evidence about how law can be used to improve population health; abstracts are being accepted until November 15, 2011.

USDA Declaring Six Serotypes of E. coli as Adulterants

The U.S. Department of Agriculture (USDA) today is declaring six other serogroups of Shiga toxin-producing E. coli (STEC) (O26, O45, O103, O111, O121, and O145). The Agency has determined that they, as well as O157:H7, are adulterants of non-intact raw beef products and product components within the meaning of the Federal Meat Inspection Act (FMIA).


Beginning in March 2012, any raw ground beef, its components, and tenderized steaks that test positive for non-O157:H7 Shiga-toxin producing E.coli strains O26, O103, O45, O111, O121 and O145 will be banned from being sold for public consumption.


The Centers for Disease Control and Prevention (CDC) identified these particular serogroups of non-O157:H7 Shiga-toxin producing E.coli, or non-O157 STEC, as those responsible for the greatest numbers of non-O157 STEC illnesses, hospitalizations, and deaths in the United States.

Lessons From Europe in the E. Coli Outbreak

Perhaps we have focused too much on traceability and should put more resources into epidemiology. Perhaps the imbalance is resources to traceability is because it provides concrete results that can immediately be demonstrated and showcased. In addition, large businesses already invested in traceback ability. Traceability is important, but traceability matters little if the epidemiology is incorrect or incomplete.


Jim Prevor wrote, "People are dropping dead from eating food and we are too cowardly to suggest irradiation. This is bizarre. The failure of public health authorities to demand the use of irradiation is evidence of a politically influenced establishment that is not, in fact, putting public health first."  


Of course, public resistance to the technology is also a reason for underutilization of irradiation. However, there is no doubt that irradiation of produce that is eaten raw could save many lives. For more information on this topic, visit the NPR website Irradiation Underused To Fight E. Coli in Foods. 

Proposed Foodborne Illness Reduction Act of 2011 (S. 1529)

Senator Gillibrand introduced bill S.1529 in the U.S. Senate yesterday. The bill is titled as the "Foodborne Illness Reduction Act of 2011''.

Extension of Comment Period on FDA's Guidance for NDI Notifications

Today FDA published in the Federal Register a notice granting a 60-day extension (until December 2, 2011) for comments on the FDA's draft guidance on New Dietary Ingredient ("NDI") notifications, which the Agency issued on July 5, 2011. More information is available here.

Bayer to pay $750 Million to End Lawsuits Over Genetically Engineered Rice

According to Bloomberg, Bayer AG agreed to a $750 million settlement to resolve claims with about 11,000 U.S. farmers who said a strain of the company's genetically modified rice tainted crops and ruined their export value. The settlement ends scores of lawsuits filed against the Bayer CropScience unit by farmers in Texas, Louisiana, Missouri, Arkansas, and Mississippi.

In August 2006 the USDA said that trace amounts of the company's experimental LibertyLink strain were found in U.S. long-grain rice. Within four days, declining rice futures cost U.S. growers about $150 million, according to a complaint filed by the farmers.

The official Bayer CropScience statemen states in part, "Although Bayer CropScience believes it acted responsibly in the handling of its biotech rice, the company considers it important to resolve the litigation so that it can move forward focused on its fundamental mission of providing innovative solutions to modern agriculture."

Summary of Key Provisions of the Food Safety Modernization Act

The FDA Food Safety Modernization Act (FSMA), which signed into law by President Obama on January 4, 2011, amends the Federal Food, Drug, and Cosmetic Act to shift the focus of the Food and Drug Administration (FDA) from primarily reacting to food safety problems to prevention.

A summary of key new provisions and their impact is available on the Institute for Food Laws & Regulations website here.

Neal Fortin is the author of Food Regulation: Law, Science, Policy, and Practice, and he is Professor and Director of the Michigan State University Institute for Food Laws and Regulations, where he teaches online courses in Food Regulation in the United States, International Food Law, and Codex Alimentarius. 

FDA's Nanotechnology Guidance

Nanotechnology is the science of manipulating materials on the nanoscale.  “Nanotechnology,” “nanoscale,” and related terms lack definitions in U.S. food law. However, common use of the term “nanotechnology refers to the engineering (deliberate manipulation, manufacture, or selection) of materials that have at least one dimension in the size range of approximately 1 to 100 nanometers.

Nanotechnology is an emerging technology that has the potential to be used many products, including drugs (e.g., to increase bioavailability) and foods (e.g., to improve food packaging). Nanoscale materials can have different chemical, physical, or biological properties compared to their conventionally scaled counterparts. These materials warrant further regulatory attention because the properties and phenomena of nanoscale materials can affect safety, effectiveness, performance, and quality of the materials. 

Rather than define nanotechnology, FDA issued draft guidance on nanotechnology that defines when the agency increase product scrutiny based on the application of nanotechnology. Specifically, FDA will ask:

1. Whether an engineered material or end product has at least one dimension in the nanoscale range (approximately 1 nm to 100 nm); or

2.  Whether an engineered material or end product exhibits properties or phenomena, including physical or chemical properties or biological effects, that are attributable to its dimension(s), even if these dimensions fall outside the nanoscale range, up to one micrometer.

  

Note that FDA is interested in the engineered nanoscale materials and the application of nanotechnology as distinguished “from those products that contain incidental or background levels of nanomaterials or those that contain materials that naturally occur in the nanoscale range. FDA is particularly interested in the deliberate manipulation and control of particle size to produce specific properties, because the emergence of these new properties or phenomena may warrant further evaluation. This is distinct from the more familiar use of biological or chemical substances that may naturally exist at small scales, including at the nanoscale, such as microorganisms or proteins.”

  

FDA’s product focused review is similar to the agency’s regulatory policy for recombinant DNA techniques (GMOs). As with GMOs, FDA does not categorize the technology as either benign or dangerous. A product’s final attributes determine the outcome of FDA’s review. However, the agency considers the process of a product’s development as a part of the means for determining the attributes of the final product.

FDA’s draft guidance, Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology, Draft Guidance for Industry (June 2011) is available here. 

A more sophisticated crisis response

Alberto Alemanno has a thought provoking article regarding the response to the recent E. coli outbreak. Would it have been better if the European Commission had taken on more powers?

The Commission and the European Food Safety Authority (EFSA) could supervise the risk assessments conducted across Europe and coordinate the task of communicating the outcome of those assessments. A central organization could have more sophisticated ability to collate, assess, and distribute information than individual national authorities.

Read more here.

Alberto Alemanno is a guest instructor at the Institute for Food Laws and Regulations at Michigan State University. He is associate professor of law at École des Hautes Études Commerciales (HEC), Paris, adjunct professor of global risk regulation at Georgetown University Law Centre, and editor of the European Journal of Risk Regulation.

Training and an Integrated Food Safety System

Rightfully so, the FDA Food Safety Modernization Act includes language recognizing the importance of integrating state and local regulatory programs with the federal ones. Training is key to the success of creating an integrated food safety system.  On this topic, Joseph Corby, Gerald Wojtala, and Craig Kaml co-wrote the cover story of the April/May 2011 issue of Food Safety Magazine, titled, "Training in an Integrated Food Safety System: Focus on Food Protection Officials."

Global Food Law & Policy

The Summer Academy on Global Food Law & Policy ++ 25-29 July 2011 ++ Lake Como, Italy ++ few places available ++  www.lexxion.eu/conferences ++ Apply now!