FDA's New Record Access Authority

FDA published an Interim Final Rule to modify their regulations on the establishment, maintenance, and availability of records. Before passage of the Food Safety and Modernization Act (FSMA), section 414(a) of the FD&C Act provided the Secretary of Health and Human Services (and by delegation FDA) with access to records relating to food that was reasonably believed to be adulterated and present a threat of serious adverse health consequences or death to humans or animals. FSMA expanded FDA’s records access authority to records relating to include any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner and foods which FDA considers a reasonable probability that the use of or exposure to the article of food will cause serious adverse health consequences or death to humans or animals. 

Although the majority of the rule tracks the FSMA language, one important addition has been made.  Records are required to be “provided must be made available as soon as possible, not to exceed 24 hours from the time of receipt of the official request.”   

21CFR § 1.361 What are the record availability requirements?
When FDA has a reasonable belief that an article of food, and any other article of food that FDA reasonably believes is likely to be affected in a similar manner, is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, or when FDA believes that there is a reasonable probability that the use of or exposure to an article of food, and any other article of food that FDA reasonably believes is likely to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animals, any records and other information accessible to FDA under section 414 or 704(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350c and 374(a)) must be made readily available for inspection and photocopying or other means of reproduction. Such records and other information must be made available as soon as possible, not to exceed 24 hours from the time of receipt of the official request, from an officer or employee duly designated by the Secretary of Health and Human Services who presents appropriate credentials and a written notice.

FDA’s record access authority under section 414 is separate from previously existing records access authority provided in commodity specific regulations, such as the Low-Acid Canned Food regulations (21 CFR part 113), the Acidified Food regulations (21 CFR part 114), the Juice Hazard Analysis and Critical Control Point (HACCP) Systems regulations (21 CFR part 120), the Fish and Fishery Products regulations (21 CFR part 123), and the Infant Formula regulations (21 CFR part 106). FSMA did not amend these commodity specific record access requirements.  

FDA’s records access authority under sections 414(a) and 704(a) applies to both domestic and foreign persons (excluding farms and restaurants) who manufacture, process, pack, transport, distribute, receive, hold, or import articles of food when the circumstances in section 414(a)(1) or (2) of the FD&C Act are met. 

FDA requests to access and copy records are most likely to occur when FDA becomes aware of reportable food reports, as defined in section 417(a)(2) of the FD&C Act [21 U.S.C. 350f(a)(2)], foodborne outbreaks, epidemiological evidence implicates a food causing illness or death, product recalls, adverse event reports, and consumer complaints.

FDA’s authority under FD&C Act §§ 414(a) and 704(a) applies to records that are required to be kept by regulation under section 414(b), as well as any other records related to the manufacture, processing, packing, transporting, distribution, receipt, holding, or importation of the food believed to be affected and any other article of food believed to be affected in a similar manner.  Examples of records that FDA can access and copy include:

•       Manufacturing records

•       Raw materials (ingredients and packaging) receipt records

•       Product distribution records

•       Product inventory records

•       Test records

•       Recall records

•       Reportable food records      

•       Customer distribution lists

•       Complaint and adverse event records

FDA's authority to access records under sections 414(a) and 704(a) of the FD&C Act does not apply to records from farms, as defined in 21 CFR 1.328, records from restaurants, as defined in 21 CFR 1.328, or records relating to food that is within the exclusive jurisdiction of the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg Products Inspection Act (21 U.S.C. 1031 et seq.)  FDA's authority to access records also does not apply to:

·      Recipes, as defined in 21 CFR 1.328 (but a list of the ingredients used to manufacture a food, without quantity information and manufacturing instructions, is not a recipe.)

·      Financial data

·      Pricing data

·      Personnel data

·      Research data

·      Sales data other than shipment data regarding sales 

The refusal to permit access to or copying of records requested under section 414(a) of the FD&C Act is a prohibited act under section 301(e) of the FD&C Act [21 U.S.C. 331(e)]. In response to such a refusal, FDA may initiate civil or criminal action, as necessary, including:

•       Suspension of the food facility’s registration, thus preventing the firm from importing or exporting food or introducing food into interstate or intrastate commerce

•       Administrative detention of the food to control its movement

•       Seizure of the food

•       Issuance of a mandatory recall order for the food

•       Injunction against the firm 

•       Refuse admission of food offered for import into U.S. commerce

FDA has issued two guidance documents:

• Questions and Answers Regarding Establishment and Maintenance of Records by Persons Who Manufacture, Process, Pack, Transport, Distribute, Receive, Hold, or Import Food (Edition 5).

• Draft: FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act.

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. 

Federal Meat Inspection Act Preempts California Law on Non-Ambulatory Animals

In a unanimous opinion, the U.S. Supreme Court held that the Federal Meat Inspection Act (FMIA) expressly preempts a California law that dictated slaughterhouses must reject non-ambulatory pigs.

 The California law, section 599f of the California state penal code, prohibited slaughterhouse purchase or sale any non-ambulatory livestock and prohibited the processing of meat from non-ambulatory livestock for human food. This law was adopted in 2008 after the Humane Society released an undercover video showing workers at a Westland/Hallmark Meat Co. slaughterhouse in California dragging, kicking, and electro- shocking sick and disabled cows in an effort to move them. The video led the federal government to institute the largest beef recall in U. S. history in order to prevent consumption of meat from diseased animals.

First enacted in 1906, the FMIA was amended in 1978 to require all slaughterhouses comply with the standards for humane handling and slaughter of animals set out in the Humane Methods of Slaughter Act of 1958 (72 Stat. 862, 7 U.S.C. §1901 et seq.). The FMIA express preempts state laws “with respect to premises, facilities and operations of any establishment at which inspection is provided under . . . this [FMIA] which are in addition to, or different than those made under [FMIA]” (21 U. S. C. § 678).

 “The FMIA’s preemption clause sweeps widely—and in so doing, blocks the applications of §599f challenged here. The clause prevents a State from imposing any additional or different—even if non-conflicting—requirements that fall within the scope of the Act and concern a slaughterhouse’s facilities or operations. And at every turn §599f imposes additional or different requirements on swine slaughterhouses: It compels them to deal with nonambulatory pigs on their premises in ways that the federal Act and regulations do not. In essence, California’s statute substitutes a new regulatory scheme for the one the FSIS uses. Where under federal law a slaughterhouse may take one course of action in handling a nonambulatory pig, under state law the slaughterhouse must take another.” 565 U. S. ____ (2012).

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. 

Get Poisoned for Free

Bill Marler, guest instructor for the Institute for Food Laws and Regulations, is offering to give a book to each new person who subscribes to his blog (up to 200 hardcover books).  Just subscribe here and email Mr. Marler your address at bmarler@marlerclark.com.

The book, Jeff Benedict's Poisoned, is a great read.  So is Bill Marler's blog. Win Win.

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!

Time to Modernize the Toxic Substances Control Act of 1976

High-profile media coverage of specific chemicals, like bisphenol A in infant bottles and can liners, creates anxiety about food regulation, but the problems of risky chemical exposure is much greater with non-food consumer goods. Chemicals added to food and from food contact materials are regulated as food additives under a relatively stringent review process under the Food, Drug, and Cosmetic Act.

On the other hand, non-food chemicals are regulated under the Toxic Substance Control Act of 1976 (TSCA), which is widely recognized as ineffective in protecting us from hazardous chemicals in the marketplace. In three decades of existence, TSCA has been used to regulate only five chemicals or chemical classes out of the thousands of chemicals that are in commerce. Under TSCA, chemical companies have no responsibility to perform premarket testing or postmarket follow-up of the products that they produce; in fact, TSCA creates disincentives for the companies to produce such data. Voluntary programs have been inadequate in resolving problems.

Senator Frank R. Lautenberg (D-NJ) introduced new legislation to modernize the Toxic Substances Control Act of 1976 (TSCA) and protect Americans from exposure to dangerous toxins. The law would for the first time require that chemical manufacturers demonstrate the safety of industrial chemicals used in everyday household products.  Senator Lautenberg launched a video on his Facebook and Twitter pages to build support for chemical safety reform and his "Safe Chemicals Act of 2011."  Watch it here.

Public Morals Proposed as a Grounds to Ban GMOs

Public morals, public order, "social policy objectives," and "historical heritage" are some of the reasons the European Commission has proposed as grounds for a national ban of genetically modified crops. The plan presented by John Dalli, the European commissioner for health and consumer policy, is to give governments greater leeway to ban GM crop cultivation for factors other than health or environmental grounds. The legal service of the Council of Ministers criticized the proposal as contrary to World Trade Organization (WTO) rules and the EU's own single market. More information is available from Jennifer Rankin, Growing GM crops 'could pose a threat to public order,' EuropeanVoice.com (Feb. 3, 2011).

FSIS Announces Final Rule for Interstate Shipment of State-Inspected Meat and Poultry Products

On April 19, 2011, the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced a final rule that will broaden the market for smaller state-inspected plants. This voluntary cooperative interstate shipment program will allow select establishments to ship meat and poultry products, bearing an official USDA mark of inspection, across state lines.

Advance copy of the document, Cooperative Inspection Programs: Interstate Shipment of Meat and Poultry Products (Apr 19, 2011), submitted to Office of the Federal Register is available here. 

FDA Announces Food Defense Mitigation Strategies Database

The new online database was developed by the Food and Drug Administration (FDA) for the food industry to help protect the food supply from deliberate acts of contamination or tampering. The Food Defense Mitigation Strategies Database (MSD) provides a range of preventive measures that companies may choose to implement to better protect their facility, personnel, products, and operations. Visit the Mitigation Strategies Database here.

Summer Academy on Global Food law & Policy

The third Summer Academy in Global Food Law & Policy will take place at Como Lake - Italy, July 25-29, 2011, at the beautiful Villa La Collina. A distinguished faculty from relevant food organizations (WTO, Codex, EFSA, EU Commission), industry (Coca Cola) as well as academia (Michigan, Bocconi, HEC Paris) will be animating cutting-edge discussions on the latest developments in global food governance, from food private standards to health claims, from US Food Modernization Act to novel food regulation. 

Among the those presenting are four faculty from the Institute for Food Laws and Regulations (IFLR) at Michigan State University: Neal Fortin, Professor at MSU and IFLR Director along with IFLR guest instructors Alberto Alemmano, Associate Professor of Law at HEC Paris, Gretchen Stanton,  Senior Counsellor at WTO, and Raymond O'Rourke, Barrister, Ireland.

For more information on the program and the faculty, please find the brochure here and more information here and here. Please don't hesitate to contact Nikola Bock (bock@lexxion.de) for more information.

Chief Justice Roberts Lectures AT&T on the Differences between Corn and Corny

In the recent FCC v. AT&T decision, the Supreme Court unanimously shot down the argument that corporations have "personal privacy" which allows them to withhold information under the personal privacy exceptions to the Freedom of Information Act (FOIA). (Justice Kagan did not participate.) AT&T argued that since Congress had defined "person" to include corporations, "personal privacy" rights should apply to a corporation. AT&T argued that the adjectival form of the defined word, personal, should refer to the defined word, person. 

Chief Justice Roberts gave AT& T a lesson on the the complexity and nuance of American English with some wry humor:

Adjectives typically reflect the meaning of corresponding nouns, but not always. Sometimes they acquire distinct meanings of their own. The noun "crab" refers variously to a crustacean and a type of apple, while the related adjective "crabbed" can refer to handwriting that is "difficult to read," Webster's Third New International Dictionary 527 (2002); "corny" can mean "using familiar and stereotyped formulas believed to appeal to the unsophisticated," id., at 509, which has little to do with "corn," id., at 507 ("the seeds of any of the cereal grasses used for food"); and while "crank" is "a part of an axis bent at right angles," "cranky" can mean "given to fretful fussiness," id., at 530.

In short, Chief Justice Roberts held that a corporation doesn't qualify for a "personal privacy" exemption under the law. 

"We trust that AT&T won't take it personally," he wrote.

The full opinion is available here.

EU BPA Ban Now in Effect

A ban prohibiting the manufacture in the European Union of baby bottles containing Bisphenol A (BPA) became effective March 1, 2011. BPA is an organic molecule that is used in the manufacture of polycarbonate plastics. Small amounts of BPA can be released from plastic containers into the food they carry if these containers are heated at high temperatures. According to scientific evidence, infants' ability to eliminate BPA is still building up during their first six months of life.
The ban of the manufacture of baby bottles with BPA was adopted in January (EU Directive (2011/8/EU) and entered into force on March 1. For more information, visit Alberto Alemanno's blog here.

‘Cheeseburger bill’ would block obesity lawsuits

Food Safety News reports that Minnesota's State Rep. Dean Urdahl, R-Grove City, has reintroduced legislation to bar Minnesotans from suing their favorite fast food restaurants for making them fat. The Personal Responsibility in Food Consumption Act, also known as the "cheeseburger bill," would prevent anyone in Minnesota from suing a fast-food restaurant for making them fat.

Twenty-three other states have passed similar laws according to the National Restaurant Association. Of course, anyone can sue anyone in America, but suits like this are summarily thrown out of court—even without hamburger shield laws. "You made me fat" lawsuits are going forward nowhere except on television. ABC's "Harry's Law" recently had a story with an overweight mother of several plump children who won $880,000 in an out-of-court settlement.

Black on Meat (or Lack Thereof) at Taco Bell

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FDA's First Year Report on the Reportable Food Registry

The Food and Drug Administration's (FDA) report on the first year of the Reportable Food Registry states that the data, "represent an important tool for targeting inspection resources, bringing high risk commodities into focus, and driving positive change in industry practices–all of which will better protect the public health." Commodities that feature prominently in the Reportable Food Registry will receive additional FDA attention because the Food Safety Modernization Act mandates risk-based allocation of FDA resources.

Advancing Public Health Obesity Policy Through State Attorneys General

Jennifer Pomeranz and Kelly Brownell with the Yale Rudd Center for Food Policy & Obesity have authored "Advancing Public Health Obesity Policy Through State Attorneys General." The article refers to the role played by state attorneys general in public health policy on tobacco. They contend that attorney generals "can be leaders in formulating and effectuating obesity and food policy solutions." The article also takes note of recent actions by state attorney generals have taken regarding purported misleading labeling of food and beverage products.

Toxic Waste Candy?

FDA announced the recall of Toxic Waste® brand Nuclear Sludge® Chew Bars, all flavors due to elevated lead levels.

This puts a new twist on truth in labeling.

"Neal Fortin literally wrote the book on the nation's food laws"

CBS WLNS interviewed me regarding the FDA Food Safety Modernization Act.

The Food Safety Enhancement Act Passes the House

The U.S. House of Representatives passed Food Safety Enhancement Act in the final days of the 111th Congress. Now the bill heads for the desk of President Obama, who is expected to sign it into law. You may find a copy of the latest available GPO version of the text - this is not final - here, courtesy of Charles Woodhouse. This provisional text (240 pages) was extracted from the 2,000 pages of HR 3082. Alternatively, you may go here and scroll down to p. S10745).

Happy Holidays

Senate Passes Overhaul of Food Safety Law

     The Senate this morning passed an overhaul of the nation's food-safety system by a vote of 73 to 25. The legislation would strengthen the Food and Drug Administration. Staunch opposition by Senator Tom Coburn of Oklahoma forced months of delay, because he wanted less food safety regulation, not more.
     Despite unusual bipartisan support, the bill could still die because the Senate must be reconciled with version passed earlier by the House of Representatives. The Senate's version includes an local-food producers' exemption introduced by Senator Jon Tester. 
     An article of the passage is available here in the New York Times.

Federal Safety Standards Would Help Small Farms

Matthew Enis of Supermarket News wrote a column explaining why pending food safety legislation should not let small, independents off the hook. Some independent growers and food activists fear that the FDA would use increased powers to harass small farmers and the increased compliance cost could them out of business. 

"The fact is, the local foods movement is enjoying an all-purpose halo effect right now, but advocates can't take safety for granted. It's still highly unlikely that a farmers' market will ever cause a multi-state outbreak. But, the Internet and social media tools will magnify the effect of minor outbreaks in the future. If small growers want to maintain their wholesome image, they should expect all of their peers to be meeting the same standards for safety."

How Food Recalls Work - A Look at Distribution Technology

The recent recall of nearly half a billion eggs reignited the debate over mandatory tracking for food distribution reaching back to the farm. Stephen Jannise of Distribution Software Advice has written an interesting about the egg recall. He created a hypothetical, behind-the-scenes illustration of how a food recall works. You can read it here.

IOM Front-of-Package Label Committee report

The Institute of Medicine (IOM) released its Front-of-Package (FOP) labeling report. This Phase I report provide a detailed examination of about 19 of the existing FOP schemes and some recommendations about what such schemes ought to do. As the IOM press release explains:

A multitude of nutrition rating, or guidance, systems have been developed by food manufacturers, government agencies, nutrition groups, and others in recent years with the intent of helping consumers quickly compare products’ nutritional attributes and make healthier choices. Ratings are typically communicated to shoppers through symbols placed prominently on food packaging, usually on the front, or on retail shelf tags. Unlike the Nutrition Facts panel, these rating systems and symbols are unregulated, and different systems focus on different nutrients. The variation may confuse consumers, and questions have been raised about the systems’ underlying nutritional criteria.

Marion Nestle provides a good summary of the report here.