Reps. John D. Dingell (D-MI), Chairman of the Committee on Energy and Commerce, and Bart Stupak, Chairman of the Subcommittee on Oversight and Investigations, today announced plans to hold a hearing related to the Salmonella Saintpaul outbreak.
Thursday, July 10, 2008
Dingell, Stupak Announce Hearing on FDA's Struggle with Salmonella Outbreak
Thursday, July 03, 2008
Salmonella Saintpaul Outbreak: Concerns About FDA/CDC Lack of Trace Back The Control Group
Interesting comments from Jim Prevor, the Perishable Pundit at http://www.perishablepundit.com/index.php?date=7/03/08:
. . . It was good news to learn that CDC was basically starting anew and doing new survey work with people who became ill after June 1, 2008. This survey work would involve additional questions and presumably build on learning from inadequacies in the initial investigation of those who fell ill in April and May. . . .
What was shocking — and very disappointing for the produce industry — was word that even in this new investigation, CDC is not doing any traceback of the control group. This group consists of people similar in demographics to the ill people but who did not fall ill.
Our interview with Michael T. Osterholm PhD, M.P.H., focused on the necessity for doing traceback with the control group. Here is what Dr. Osterholm said:
…it is not biologically plausible to have Mexico and Florida both at the source of this outbreak. It epitomizes the ineptitude of the investigation. FDA and CDC should have obtained tomato product consumption information from both outbreak cases and controls. They needed to conduct full fledged tracebacks all the way back to the source not only of the sick cases but of the control group as well.
The epidemiology conducted to learn what product is associated with this outbreak by interviewing those sick and those not sick on what they were eating is a prerequisite but the epidemiology needed to go further. It was critical for the investigators to learn the locations of where both the cases and controls ate tomatoes and trace back from there.
When doing the traceback, you may come up with a few possibilities of where the tomatoes came from. If you collect data over time of the cases and controls, using the same methods to make the product association, you may find 85 percent of outbreak cases trace back to a certain field or grower, or re-packer versus the control product. Then you begin to get a much better handle on where product came from.
Q: Why did the government forego this strategy?
A: FDA and CDC have not made this a priority. They will never find a silver bullet by just tracing back a product. They’re looking for a cluster that matches up exactly with the one gun barrel. They’re under the false impression that they’re going to get a clean, clear-cut answer by finding the magic cluster. They need to do this case/control approach.
Now whatever happened with the initial investigation, whatever judgments or considerations were made, this much is beyond dispute: It didn’t work.
A quote attributed to Albert Einstein defined insanity as doing the same thing over and over again yet expecting different results. So surely CDC should be open to enhancing its methodology. Certainly there is no way that doing a traceback on the control group could hurt.
We have Dr. Osterholm, a highly credible person with extensive experience, saying this is a necessity. This is from a man who was doing traceback in Salmonella investigations on tomatoes a decade ago.
So, we have a methodology that has not been working, a highly credible source suggesting a specific improvement in that methodology, yet when asked, CDC gave a simple response of no, it is not tracing back the control group. . . .
This CDC also needs to consider its dismissive manner. An issue such as this merits an explanation. In light of the failure of the last traceback and the input from Dr. Osterholm, if CDC doesn’t want to do a traceback on the control group, it should have the decency to explain why to the general public.
Does CDC lack the resources required? Does it have a substantive disagreement with Dr. Osterholm?
The people at CDC are hired by the citizens of America to handle this portion of their affairs. A decent respect for the people who pay the bills requires CDC to be more transparent in its decision-making process..
Tuesday, July 01, 2008
IDFA Files Lawsuit to Stop Ohio's No-rBST Labeling Law
The International Dairy Foods Association (IDFA) filed a lawsuit against the State of Ohio challenging the state's new regulations regarding the labeling of dairy products from cows that have not been treated with artificial growth hormones. In the lawsuit, IDFA says the Ohio rule interferes with the First Amendment right of its members to communicate truthful information to Ohioans and with interstate commerce. “The practical effect of the Ohio rule silences manufacturers of dairy products and prevents Ohioans from knowing whether artificial growth hormones have been used in dairy products,” said Peggy Armstrong, IDFA communications director. To read the news release, click here. To view IDFA's complaint, motion and brief, click here.
Friday, June 27, 2008
Lou Dobbs: Bush Should Be Impeached for Salmonella Outbreak
An angry Lou Dobbs of CNN assailed the ineptitude of the Food and Drug Administration (FDA) and place the blame squarely on President George W. Bush, calling for his impeachment (reported by Jeff Poor, Business & Media Institute).
On June 18, Dobbs called the FDA “excessively intellectually challenged.” The night before he called the FDA “moronic.”
“The FDA, led by complete moronic, unengaged incompetents,” Dobbs said on his June 17 broadcast. “The idea that they would sit there and say that they’re not going to reveal where a cluster of this outbreak occurred, this is arrogant beyond belief. Who in the world do these idiots think they are? Who do they think they’re working for?”
Thursday, June 05, 2008
CSPI Proposes ban on Some Artificial Food Dyes
The Center for Science in the Public Interest (CSPI) has petitioned the FDA to ban the artificial food dyes Yellow 5, Yellow 6, Red 3, Red 40, Blue 1, Blue 2, Green 3, and Orange B because they may cause hyperactivity and other behavioral problems in some children. You can see a CBS Evening News segment on this topic here.
Synthetic food dyes have been controversial for decades, but not until recently had any studies shown adverse effects. Information on three recent studies on food dyes and behavior are at available here on CSPI’s website.
Monday, June 02, 2008
Enhancing State and Local Roles in Food Safety - Public Symposium June 17, 2008
The symposium kicks off a new project in which three national organizations representing state and local food safety and health officials – The Association of Food and Drug Officials (AFDO), the Association of State and Territorial Health Officials (ASTHO), and the National Association of County and City Health Officials (NACCHO) – will collaborate with The George Washington University (GWU) School of Public Health and Health Services to forge an updated agenda for enhancing the contribution state and local agencies make to the nation’s food safety system. The project is funded by the Robert Wood Johnson Foundation and is being coordinated by GWU research professor Michael R. Taylor.
Confirmed speakers at the June 17 symposium include USDA Under Secretary for Food Safety Richard Raymond, FDA Associate Commissioner for Regulatory Affairs Margaret Glavin, state and local food safety regulators (Joe Corby of New York and David Ludwig of Maricopa County, Arizona), state and local health officials (David Bergmire-Sweat of North Carolina and Joseph Russell of Flathead County, Montana), David Gombas of United Fresh Produce Association, Bob Brackett of the Grocery Manufacturers Association, and Caroline Smith DeWaal of the Center for Science in the Public Interest.
Two additional workshops will be hosted by ASTHO, NACCHO, and AFDO over the summer to develop specific proposals for enhancing state and local roles in foodborne illness surveillance, outbreak response, food safety regulation and inspection at state and local levels.
In October 2008, the proposals developed at the workshops, which could include changes in law, policy, programs and resources, as well as other ideas for building a more effective, nationally integrated food safety system, will be discussed at a second public symposium in Washington for all interested stakeholders.
The June 17 symposium will be held from 8:30 am-12:30 pm in the Media and Public Affairs Building on the GWU campus in Washington, D.C., at 21st and H St., NW. The MPA building is located three blocks from the Foggy Bottom Metro Station on the Orange/Blue lines.
Please RSVP to foodsafety@gwumc.edu by June 10 if you would like to attend. If you have any questions, please contact Stephanie David at Stephanie.David@gwumc.edu.
Harnessing Knowledge to Ensure Food Safety
The Food Safety Research Consortium (FSRC) released a new report that calls for sweeping changes in the way food safety information is collected and shared. The report, “Harnessing Knowledge to Ensure Food Safety: Opportunities to Improve the Nation’s Food Safety Information Infrastructure,” was written by Michael Taylor (George Washington University) and Michael Batz (University of Florida) with funding from the Robert Wood Johnson Foundation.
Some key findings include:
· System-wide improvement in how food safety information is collected and shared is essential to achieving the vision of a risk-based, preventive system in the Food and Drug Administration’s Food Protection Plan and in most of the food safety bills being developed in Congress.
· This lack of coordination is a consequence of the highly decentralized nature of the food safety system, built-in obstacles to data sharing in many government and private organizations and the lack of incentives and means for organizations and individuals to help meet the information needs of the system as a whole.
To address these problems, the authors recommend the following:
· Establish a national policy making it the duty of all federal agencies to better coordinate information collection, consider the information needs of the system as a whole, and maximize information sharing among all levels of government and with the private sector.
· Establish a forum to foster communication and collaboration among government, industry, consumers and academia to solve food safety information problems.
· Give high priority to enhancing the nation’s investment in food safety epidemiology and making the collection and sharing of epidemiological data more responsive to the needs of regulators, the food industry and consumers.
· Use the Web to connect dispersed databases and electronic networks in order to make it easier for those seeking food safety information to find it.
· Do a better job of prioritizing information collection and making valuable data generated by academic researchers and private firms more readily available to others in the food safety system.
· Provide adequate public resources to implement the new food safety information policy and program.
The full report and executive summary are available from the FSRC Web site at: http://www.thefsrc.org/FSII/events.htm.
Thursday, May 22, 2008
Bisphenol A Report
The Congressional Research Service released Bisphenol A (BPA) in Plastics and Possible Human Health Effects, available at http://assets.opencrs.com/rpts/RS22869_20080505.pdf.
Tuesday, May 20, 2008
Who's Minding the Store: The Current State of Food Safety and How It Can be Improved
A number of people have asked for more information on the conference, Who's Minding the Store: The Current State of Food Safety and How It Can be Improved. Marler Clark has put the PowerPoint presentations from the conference on their website here.
I have attended a great many conferences, and this one was a stand out. Hats off to William Marler, Marler Clark LLP PS, Kenneth M. Odza, Stoel Rives LLP, and the Seattle University School of Law!
Thursday, May 15, 2008
Is the Green Fairy a Myth?
A recent article in the Journal of Agricultural and Food Chemistry compares modern day absinthe with pre-ban (before 1915) absinthe. “The authors conclude that the thujone concentration of preban absinthe was generally overestimated in the past. The analysis of postban (1915–1988) and modern commercial absinthes (2003–2006) showed that the encompassed thujone ranges of all absinthes are quite similar, disproving the supposition that a fundamental difference exists between preban and modern absinthes manufactured according to historical recipes. Analyses of pinocamphone, fenchone, base spirits, copper, and antimony were inconspicuous. All things considered, nothing besides ethanol was found in the absinthes that was able to explain the syndrome ‘absinthism’.”
I have to take issue with the wording of the final conclusion, however, as it seems overbroad. The legend of absinthe’s psychotropic properties may exceed reality. However, the authors of this recent study only tested for a limited number of chemicals. Absinthe contains essences from a number of herbs that have long been recognized for medicinal properties, such as common wormwood (Artemisia absinthium L.), anise (Pimpinella anisum L.), hyssop (Hyssopus officinalis L.), and Florence fennel (Foeniculum Vulgare Mill.). The pharmacological properties of the mix remains a scientific mystery.
Wednesday, May 07, 2008
GlaxoSmithKline Petitions FDA to Prohibit Weight Loss Structure/Function Claims
GlaxoSmithKline Consumer Healthcare (GSK) and others submitted a citizen petition to the Food and Drug Administration (FDA) asking the agency to prohibit weight-loss structure/function claims for dietary supplements. In addition to prohibiting weight loss claims, the petition asks FDA to prohibit claims for energy expenditure, modulation of carbohydrate metabolism, increased satiety or suppression of appetite, increased fat oxidation or reduced fat synthesis, and blockage of fat absorption.
FDA’s longstanding position has been that weight loss claims are permissible structure/function claims. However, the petition urges FDA to change its position on the ground that: (1) recent evidence establishes that overweight is a risk factor for disease; (2) consumers believe that there is a relationship between weight loss and a reduction of risk of disease; (3) claims that a product will reduce a risk factor for disease are disease claims; (4) the use of ineffective therapies can divert consumers from safe and effective therapies such as GSK’s weight loss drug Alli; and (5) manufacturers of weight loss supplements should be forced to substantiate their claims through health claim petitions before going to market.
Hat tip to Ricardo Carvajal for this information.
Friday, May 02, 2008
Fixing Food Safety: Protecting America's Food Supply from Farm-to-Fork
The Trust for America's Health (TFAH) released a new report that identifies major gaps in the nation's food safety system, including obsolete laws, misallocation of resources, and inconsistencies among major food safety agencies.
"Our goal should be reducing the number of Americans who get sick from foodborne illness. But we can't adequately protect people from contaminated foods if we continue to use 100 year-old practices," said Jeff Levi, PhD, Executive Director of TFAH. "We need to bring food safety into the 21st century. We have the technology. We're way past due for a smart and strategic upgrade."
The complete report, Fixing Food Safety: Protecting America's Food Supply from Farm-to-Fork is available at: http://healthyamericans.org/reports/foodsafety08/FoodSafety08.pdf
Thursday, May 01, 2008
Tyson Foods Enjoined from Claiming "Raised Without Antibiotics"
Sanderson Farms and Perdue Farms v. Tyson Foods
U.S. District Court for the District of Maryland
Civil Case No. RDB-08-210 (April 22, 2008)
Opinion by U.S. District Judge Richard D. Bennett
http://www.mdd.uscourts.gov/Opinions/Opinions/SandersonMemoOp.pdf
The U.S. District Court for the District of Maryland issued a preliminary injunction against Tyson Foods from continuing advertising claiming that the company’s chicken is “Raised Without Antibiotics.” The Court found that Tyson uses ionophores (types of antibiotics that are not used in human medicines and therefore present “only a miniscule threat to antibiotic resistance in humans”) in its chicken feed. The Court also found that the U.S. Department of Agriculture (USDA) erroneously approved Tyson’s “Raised Without Antibiotics” label application in May, 2007. The company was informed of the error in September 2007 and told USDA would revoke the prior approval for the label. In December, USDA approved Tyson’s application for a new label with qualifying language: “Raised Without Antibiotics that impact antibiotic resistance in humans.” But Tyson continued its advertising campaign with the unqualified “Raised Without Antibiotics” claim and un-approved variations of the qualified claim, leading Sanderson and Perdue to file suit. The Court concluded that Tyson’s advertising labels were misleading to consumers, including the qualifying language regarding antibiotic resistance in humans. The Court noted that the phrase, ‘that impact antibiotic resistance in humans,’ is not understood by a substantial portion of the consumer public…[and] may even reinforce consumer misconception. … The public interest compels that this advertising stop and that a preliminary injunction be issued in this case.”
Wednesday, April 23, 2008
Food Labeling Workshop July 23-24, 2008
This workshop presents the FDA requirements for US food labeling. The workshop format and materials are designed to provide a user-friendly approach for those new to food labeling and also provide a thorough system and reference for those experienced with food label design and review. The workshop format allows time for questions. The focus is practical, and students are encouraged to bring problem labels for hands-on review. For more information, click here.
Early bird discount (before May 15, 2008): $795
Monday, April 21, 2008
In Lean Times, Biotech Grains Are Less Taboo
And Everyone is Above Average
Patrick McGee writes, “But we do need to remind our industry, the media, and the public that we have the safest food manufacturing and distribution system in the world.” Mr. McGee’s editorial is titled, “The Good News” and appears in the current issue of Food Quality magazine.
Mr. McGee hasn’t been keeping up with Doug Powell of the International Food Safety Network, who has been a ubiquitous stickler for accuracy on this point. You can read his comments on barfblog.com, where he has a special safest-food-in-the-world section.
Another reality check comes from Phil Brasher of the Des Moines Register, who wrote:
America has the safest food supply in the world. True or False?
It's impossible to say. The statistics don't exist to make such a claim. But that doesn't stop meatpackers, lobbyists, lawmakers and even government regulators who should know better, from repeating the claim every time there's a food-borne illness outbreak or major food recall.
It's not just Americans who make the claim.
"I've lived in many countries that have the safest food in the world," says Canice Nolan, a food-safety official with the European Commission in Washington.
Saturday, April 19, 2008
FDA Globalization Act of 2008
The U.S. House of Representatives Committee on Energy and Commerce released a Discussion Draft of the "Food and Drug Administration Globalization Act of 2008." The “Discussion Draft is meant to stimulate discussion about how to provide adequate funding and authority for FDA to ensure safety of . . . food, drug, medical device, and cosmetic” products, according to a memorandum accompanying the draft legislation.
The Discussion Draft is likely to undergo significant changes during hearings and markup. Among the interesting proposals:
- an annual registration fee of $2,000 for food facilities operating in the U.S. or exporting food to the U.S.
- provide a voluntary FDA-certification program
- require 2-year inspection intervals of foreign and domestic food establishments if not certified
- require country-of-origin labeling of foods
- require labeling whether certain foods have been treated with carbon monoxide
provide FDA with mandatory recall authority - a registration fee to cover the cost of drug and device inspections
- drug and device country-of-origin labeling
- cosmetic facilities registration with the FDA at a cost of $2,000 per facility
adverse-event reporting for cosmetics - increase the capacity of FDA to monitor foreign facilities
- Fees registration, reinspection, certification, certifying agent accreditation, laboratory accreditation, export certification, and importer registration.
The Energy and Commerce Committee predicts that the food registration fees will generate approximately $600 million for food safety activities at FDA. In addition, the bill provides for the levying of substantial fines for violations of the new requirements.
A hat tip to FDA Law Blog for writing of this.
Friday, April 18, 2008
FDA: HFCS is Not "Natural"
Lorraine Heller at FoodNavigator-USA.com reports that she wrote FDA to ask whether high-fructose corn syrup could be labeled "natural." Geraldine June at the FDA responded:
"Moreover, the corn starch hydrolysate, which is the substrate used in the production of HFCS, may be obtained through the use of safe and suitable acids or enzymes. Depending on the type of acid(s) used to obtain the corn starch hydrolysate, this substrate itself may not fit within the description of 'natural' and, therefore, HCFS produced from such corn starch hydrolysate would not qualify for a 'natural' labeling term."
The corn refiners association released a press statement:
Thursday, April 17, 2008
Funding for Food and Agricultural Research
Congress is now in the final stages of writing a new Farm Bill (H.R. 2419), which should be a critical source of food and agricultural research funding through 2012. However, funding for land-grant universities conducting vital food science and technology research is in jeopardy.
Food and agricultural research, extension, and education are already chronically underfunded. The most recent proposed cut in funding for research is in excess of 75%. Federal funding for land-grant universities supports research on key problems of global, national, and regional importance in biological, environmental, physical, and social sciences relevant to agriculture, food, and the environment on a competitive, peer-reviewed basis.
We face a world with many new and emerging challenges in food and agriculture. A lack of funding will stifle scientific discovery and the spirit of innovation that will help us meet these challenges. If we are to advance the science of food and achieve our long-range vision of “a safe and abundant food supply for healthier people everywhere,” we must increase research funding, not decrease it. Food and agriculture research is an affordable program with priceless results.
This research is vital. Therefore, I urge you to help land-grant universities retain the modest level of funding for food and agricultural research, extension and education.
Please contact your Representative and Senators and ask them to maintain the overall funding level for food and agriculture research. You may find the contact information for your senators and representatives at www.house.gov and www.senate.gov.
Here is the letter I sent:
Dear (Senator/Representative):
I am writing to express my strong concern with regard to the House-Senate conference on H.R. 2419, the Farm Bill.
I am distressed by indications that existing mandatory "Research Title" funding for land-grant research, extension, and teaching will be devastated.
We need for more research funding, not less. Additional university funding is necessary to combat the growing problem of obesity; to find new conservation techniques for preserving soil and water; to develop methods to provide agricultural production at less cost (to the farmer, the consumer, and the environment); to establish key links between food and human disease; to make our food supply safer; and to find ways to feed our citizens and people in the rest of the world.
The most recent conference documents indicate a reduction of $1.244 billion from the Research Title - a cut of over 75%! This would appear to be the largest percentage cut from the baseline of any title in the Farm Bill. Food and agricultural research and education is already chronically underfunded,
We recognize that difficult decisions lie before the conferees. But these massive cuts to the Research Title are inconsistent with the increase in overall Farm Bill spending and are disproportionate to that being contemplated in other titles of the bill (such as trade and crop insurance).
The challenges facing rural America and the nation's nutrition-challenged populations have never been greater - and neither have the opportunities to meet these challenges. We cannot address these and other problems without an enhanced investment in land-grant research, extension, and teaching.
The best opportunity to do that is in this Farm Bill.
Please do not let the outcome of this Farm Bill be the destruction of existing Research Title funding. If you cannot find ways to enhance funding, I urge you to at least protect the current land-grant funding baseline.
Sincerely,
Neal Fortin
Wednesday, April 16, 2008
NY Calorie Posting Law Upheld
In a decision released today, the United States District Court for the Southern District of New York upheld the constitutionality of New York City’s calorie-posting requirement for certain restaurants. The Court ruled that the federal Nutrition Labeling and Education Act of 1990 does not pre-empt the city’s regulation, and it held that the posting requirement does not violate the free speech rights of New York State Restaurant Association members. For the complete ruling: http://www2a.cdc.gov/phlp/docs/Calorie%20decision.pdf.
Mitigating Liability
I had the pleasure to meet Kenneth Odza last week at the “Who’s Minding the Store?” seminar at Seattle University. Mr. Odza’s specialty is food liability defense law. He publishes a useful blog on this subject, the Food Liability Law Blog. You can subscribe via RSS feeder or email.
A recent blog entry talked about how meat grinding logs can mitigate supermarket liability. In one case, an salmonellosis outbreak was tied to ground beef from a supermarket chain. The meat producer could not be identified largely because the supermarket chain did not keep clear grinding logs. “For no reason other than poor record keeping, the supermarket chain, not the meat producer, bore responsibility for the outbreak (and any resulting liability). . . . Meat grinding logs can be vital tools in defending against and mitigating liability claims attributed to ground beef (especially those related to E. coli, BSE, Salmonella, etc.).”
To Mr. Odza’s advice, I would also add that keeping cooking temperature logs can similarly be vital. I once cleared a grocery store of a salmonellosis case because it had clear cooking temperature logs. Logs also can and should be an important tool for management to ensure that delegated tasks are be carried out by employees.
New FDA Food Labeling Guide
FDA’s Center for Food Safety and Applied Nutrition has published a new version of “A Food Labeling Guide.” This is an excellent basic guide to food labeling. Most frequently raised questions have been answered in easy to read, question-and-answer format.
The document note: “FDA receives many questions from manufacturers, distributors and importers about the proper labeling of their food products. This guidance is a summary of the required statements that must appear on food labels under these laws and their regulations. To help minimize legal action and delays, it is recommended that manufacturers and importers become fully informed about the applicable laws and regulations before offering foods for distribution in the United States.”
For the complete guide: http://www.cfsan.fda.gov/~dms/2lg-toc.html. For a complete list of all of FDA’s Food and Cosmetic Guidance Documents: http://www.cfsan.fda.gov/~dms/guidance.html.
Monday, April 07, 2008
Food Safety Conference at Seattle University Draws Experts from the US and Abroad
Posted on April 7, 2008 by Bill Marler
Seattle University School of Law hosts an in-depth conference titled “Who’s Minding the Store: The Current State of Food Safety and How It Can Be Improved” on April 11th and 12th, 2008. Participants include international, national and local representatives of government, the food industry, consumer organizations, scientists, and the media.
Recent years have seen a plethora of food warnings and recalls, raising new questions about the quality and integrity of our existing system for assuring food safety. Seattle was the epicenter of the Jack in the Box E. coli outbreak that sickened 600 and killed four 15 years ago. In addition to explaining how the present system works, this program is intended to discuss how changing consumer preferences are affecting the development and distribution of food, examine whether federal, state and industry oversight roles are changing, and discuss how the regulatory and judicial processes can be most efficiently balanced.
Washington Governor Christine Gregoire will present the keynote address. Featured speakers include Dr. Richard Raymond, Under Secretary for Food Safety, United States Department of Agriculture, and Dr. Patricia Griffin, Chief; Enteric Diseases Epidemiology Branch, Centers for Disease Control & Prevention.
In addition, the conference brings together international experts, including Jorgen Schlundt of the World Health Organization, Qiu Yueming of the China National Institute of Standardization, Deon Mahoney of Food Standards Australia New Zealand, Chris Griffith of University of Cardiff Wales, and Dr. Canice Nolan, of the EU.
For a detailed agenda and registration, visit:
http://www.law.seattleu.edu/cle/archive/2008/foodsafety.
Friday, April 04, 2008
2007-2008 H. Thomas Austern Memorial Writing Competitions -- Deadline is June 13
The FDLI H. Thomas Austern Memorial Writing Competitions encourage law students interested in the areas of law that affect foods, drugs, devices, cosmetics and biologics. Additionally, winning papers will be considered for publication in the Food and Drug Law Journal. Entrants must be currently enrolled in a J.D. program at any of the nation's law schools. To learn more about the 2007-2008 Writing Competitions, download the brochure.
Thursday, April 03, 2008
FARM BILL ACTION ALERT -- IMMEDIATE ATTENTION NEEDED
The following Action Alert was sent to National Association of State Universities and Land-Grant Colleges (NASULGC)Board of Agriculture Assembly and the Councils on Agricultural Research, Extension and Teaching and Governmental Affairs. I encourage you to consider adding your voice in concern over funding for the "Research, Teaching, and Extension" Title of the Farm Bill.
Below the Action Alert is a plea to the Farm Bill Conferees that provides additional information that you can may find useful.
ACTION ALERT – HOUSE and SENATE CALLS/EMAILS NEEDED - IMMEDIATELY!
TO: Board on Agriculture Assembly
Council on Agricultural Research, Extension, and Teaching
Council on Governmental Affairs
As you know, (see: www.create-21.org/alerts/02-13-2008.htm) the top Farm Bill priority for the land-grant system is mandatory funding for research, extension, and teaching.
Current documents from the House-Senate Farm Bill conference show a $1.244 billion reduction in such funding -- a 75% reduction in the "Research, Teaching, and Extension" Title. No other title in the Farm Bill received such a large percentage reduction.
We need you -- and your researchers, extension personnel, graduate students, and any other parties willing to help -- to immediately call and/or email your senators and representatives. Please urge them to communicate with the Agriculture Committee leadership in their respective chamber. (Senators Harkin and Chambliss or Representatives Peterson and Goodlatte)
WE NEED TO INUNDATE CAPITOL HILL WITH OUR CALLS AND EMAILS!
The message follows:
++++++++++++++++++++++++++++++++++++++++++++
Dear (Senator/Representative):
I am calling/writing to express my strong concern with regard to the House-Senate conference on H.R. 2419, the Farm Bill.
While it is encouraging to hear of progress being made which would bring the conference to a conclusion, I am distressed by indications that existing mandatory "Research Title" funding for land-grant research, extension, and teaching will be all but wiped out.
Over the past many years, I have heard senators and representatives from both sides of the aisle talk about the need for more funding, not less.
Additional university funding is absolutely necessary to combat the growing problem of obesity; to find new conservation techniques for preserving soil and water; to develop methods to provide more plant and animal production at less cost (to the farmer, the consumer, and the environment); and to find ways to feed our citizens and people in the rest of the world.
The most recent conference documents indicate a reduction of $1.244 billion from the Research Title — a cut of over 75%!
This would appear to be the largest percentage cut from the baseline of any title in the Farm Bill. And, it would be far below what either House or Senate Bills contained when originally passed.
We recognize that difficult decisions lie before the conferees. But these massive cuts to the Research Title are inconsistent with the increase in overall Farm Bill spending and are disproportionate to that being contemplated in other titles of the bill (such as trade and crop insurance).
The challenges facing rural America and the nation’s nutrition-challenged populations have never been greater — and neither have the opportunities to meet these challenges. We cannot address these and other problems without an enhanced investment in land-grant research, extension, and teaching.
The best opportunity to do that is in this Farm Bill.
Please do not let the outcome of this Farm Bill be the destruction of existing Research Title funding. If you cannot find ways to enhance funding, I urge you to at least protect the current land-grant funding baseline.
++++++++++++++++++++++++++++++++++++++++++++
There is a tremendous stake for the land-grant system in a positive outcome. We need you and all of your faculty, staff, graduate students, and outside supporters to make these calls and emails!
Thanks, as always, for your assistance.
PLEA TO FARM BILL CONFEREES:
DO NOT KILL THE AGRICULTURAL RESEARCH BASELINE
Based on limited available information, we are of the understanding that the tentative agreements reached by House and Senate Agriculture Committee staff on the Research Title of the Farm Bill will, if ratified by the Conferees, result in three significant fiscal impacts regarding agricultural research:
- It eliminates current law Initiative for Future Agriculture and Food Systems (IFAFS) funding – a net loss in the Farm Bill of $1.6 billion in budget authority ($1.244 billion in budget outlays)
- It creates two or three new targeted mandatory research programs for specialty crops, organics, and energy. No figures are available but the total is approximately $200 million over five years.
- It terminates these targeted programs in 2012. This will result in ZERO dollars in the Committee baseline for agricultural research in FY 2012 and the future.
This course of action would be a huge step backwards for the federal commitment to agriculture, nutrition, energy and related research – with permanent negative repercussions far beyond the five year life of the Farm Bill.
- REPEALS MORE THAN $1.2 BILLION (OUTLAYS) IN MANDATORY AG RESEARCH FUNDING: The tentative agreement would abandon funding for the IFAFS program provided in current law in the amount of $200 million per year for eight fiscal years (2010 through 2017). This would repeal $1.6 BILLION in mandatory research budget authority (and $1.244 Billion in outlays) over the 10 year budget baseline of the bill.
- TARGETED RESEARCH FUNDS ARE NOT A SUBSTITUTE: While the tentative agreement reportedly includes some mandatory funding targeted to specialty crops, organics, and renewable energy, the total amount of new mandatory research funds made available are more than ONE BILLION DOLLARS LESS THAN CURRENT LAW.
- KILLS LONG TERM COMMITMENT TO AG RESEARCH BY REPEALING PERMANENT LAW BUDGET BASELINE: Not only does the tentative agreement specifically terminate IFAFS funds beginning immediately, it would eliminate the new, targeted funds in FY 2012. This means that the budget baseline for all of these agriculture research priorities will be ZERO when the next Farm Bill is written in 2012. Specialty crops research baseline = ZERO. Renewable energy research baseline = ZERO. Organics research baseline = ZERO. IFAFS research baseline = ZERO. This would reverse more than 10 years of effort in building the budget baseline for agricultural, nutrition, renewable energy, and related research.
HOW YOU CAN HELP!
PRESERVE THE BUDGET BASELINE FOR MANDATORY AGRICULTURE RESEARCH FUNDING BY:
- PROVIDING MANDATORY FUNDS THROUGH FY 2012. DO NOT MAKE BASE FUNDING “SUBJECT TO APPROPRIATIONS” IN THE FARM BILL.
- MAINTAINING FUNDING FOR IFAFS AT THE HIGHEST AMOUNT POSSIBLE—ESPECIALLY IN FY 2012.
Aspartame safety study
Direct and indirect cellular effects of aspartame on the brain
European Journal of Clinical Nutrition (2008) 62, 451–462; doi:10.1038/sj.ejcn.1602866; published online 8 August 2007 http://www.nature.com/ejcn/journal/v62/n4/abs/1602866a.html
This study explored the direct and indirect cellular effects of aspartame on the brain. Aspartame and its breakdown compounds may disturb the brain concentrations of catecholamines.
Wednesday, March 19, 2008
Lapses in FDA's inspections for fresh spinach safety
The U.S. House of Representatives’ Oversight and Government Reform Committee has released a report from finding significant lapses in the FDA’s current inspection regime for packaged fresh spinach: http://oversight.house.gov/documents/20080312103036.pdf.
Monday, March 10, 2008
"Humane Society Sues USDA over mad-cow safety rules"
“Humane Society Sues USDA over mad-cow safety rules”
Ilan Brat et al., Wall Street Journal (Feb. 28, 2008) http://online.wsj.com/article/SB120416641582098803.html?mod=googlenews_wsj (subscription required)
The Humane Society filed suit last week against the U.S. Department of Agriculture (USDA) over a purported loophole in regulations meant to prevent bovine spongiform encephalopathy (BSE). Under USDA regulations, “downer cattle” that cannot stand or walk on their own are generally prohibited from entering the human food supply because inability to walk is a symptom of BSE. But in July 2007, USDA issued a regulatory exception to that rule, allowing federal veterinarians to determine case-by-case whether to permit non-ambulatory cattle that become injured following an initial inspection.
Thursday, March 06, 2008
Cloned Food - Son of Frankenfood?
From an interesting article in The Economist, Son of Frankenfood?:
“IT IS beyond our imagination to even find a theory that would cause the food to be unsafe.” With that ringing endorsement, Stephen Sundlof, the chief food-safety expert at America's Food and Drug Administration (FDA), this week declared food derived from the offspring of cloned cows, pigs and goats to be safe for human consumption. The decision came just days after the European Food Safety Authority (EFSA) publicly reached the same conclusion. . . . [Emphasis added.]
Nonetheless, there seem to be lingering innuendo that cloned food may be unsafe. For example, take the untrue statement from the (inappropriately named) Center for Food Safety, “In January 2008, the FDA essentially told the public that the meat and milk from cloned livestock are safe for human consumption. FDA's action flies in the face of widespread scientific concern about the risks of food from clones . . .” http://www.centerforfoodsafety.org/cloned_animals.cfm.
Can anyone think of a remotely plausible theory or scenario that would cause the food to be unsafe?
Wednesday, February 27, 2008
Guidance for Industry: Guide to Minimize Food Safety Hazards for Fresh-cut Fruits and Vegetables
Guidance for Industry: Guide to Minimize Food Safety Hazards for Fresh-cut Fruits and Vegetables Federal Register: February 25, 2008 (Volume 73, Number 37) [Page 10037-10038]
SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a final guidance document entitled ``Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables'' (the fresh-cut guidance or guidance). Previously, FDA announced the availability of the fresh-cut guidance as a ``draft final'' document, pending approval by the Office of Management and Budget (OMB) of the information collection provisions in the guidance. FDA is publishing this notice to announce that the fresh-cut guidance is now final. The text of the guidance has not changed from the previously published draft final version. The fresh-cut guidance complements FDA's current good manufacturing practice (CGMP) requirements for foods by providing specific guidance on the processing of fresh-cut produce. The fresh-cut guidance and the CGMP regulations are intended to assist processors in minimizing microbial food safety hazards common to the processing of most fresh-cut fruits and vegetables sold to consumers and retail establishments in a ready-to-eat form.
Food Labeling: Health Claims; Soluble Fiber From Certain Foods and Risk of Coronary Heart Disease
Food Labeling: Health Claims; Soluble Fiber From Certain Foods and Risk of Coronary Heart Disease Federal Register: February 25, 2008 (Volume 73, Number 37) [Page 9938-9947]
[Docket No. FDA-2008-P-0090] (formerly Docket No. 2006P-0393)
ACTION: Interim final rule.
SUMMARY: The Food and Drug Administration (FDA) is amending the health claim regulation entitled ``Soluble fiber from certain foods and risk of coronary heart disease (CHD)'' to add barley betafiber as an additional eligible source of beta-glucan soluble fiber. Barley betafiber is the ethanol precipitated soluble fraction of cellulase and alpha-amylase hydrolyzed whole grain barley flour. FDA is taking this action in response to a health claim petition submitted by Cargill, Inc. FDA previously concluded that there was significant scientific agreement that a claim characterizing the relationship between beta-glucan soluble fiber of certain whole oat and whole grain barley products and CHD risk is supported by the totality of publicly available scientific evidence. Based on the totality of publicly available scientific evidence, FDA now has concluded that in addition to certain whole oat and whole grain barley products, barley betafiber is also an appropriate source of beta-glucan soluble fiber. Therefore, FDA is amending the health claim regulation entitled ``Soluble fiber from certain foods and risk of CHD'' to include barley betafiber as another eligible source of beta-glucan soluble fiber.
Friday, February 15, 2008
Naturally Confused
Naturally Confused By Neal D. Fortin, Food Product Design (02/12/2008)
Merriam-Webster defines “natural food” in 13 words. New federal rules can be expected to add a few more.
Since 1982, USDA policy has defined "natural" as a product that contains no artificial flavoring or coloring, chemical preservative, or any other artificial or synthetic ingredient. FDA has been urged to define "natural" by regulation, but has declined. Recently, USDA initiated a rulemaking on "natural" to resolve growing controversy. . . .
http://www.foodproductdesign.com/hotnews/naturally-confused.html
Tuesday, February 12, 2008
Who's Minding the Store? - The Current State of Food Safety and How it Can be Improved
Food Safety conference at Seattle University, Organized and Co-Sponsored by: William D. Marler, Marler Clark LLP PS, and Kenneth M. Odza, Stoel Rives LLP
Marlerblog:
"Few subjects draw more immediate attention or concern than the safety of the food we eat. Recent years have included a plethora of food warnings and recalls, raising new questions about the quality and integrity of our existing system for assuring food safety. Seattle was the epicenter of the Jack in the Box E. coli outbreak that sickened 600 and killed four 15 years ago. In addition to explaining how our present system works, this program is intended to discuss how changing consumer preferences are affecting the development and distribution of food, examine whether Federal, state and industry oversight roles are changing, and discuss how the regulatory and judicial processes can be most efficiently balanced. Participants include international, national and local representatives of government, the food industry, consumer organizations and scientists."
For more information and registration:
Seattle University School of Law
Friday, January 18, 2008
Recall. Food &Toy Safety: An American Crisis
From a reader's review: "A much needed contribution to a critical discussion. Susie Hoeller has a written a timely and important book about an issue as fresh as today's headlines. Clear, urgent and articulate, she lays out in detail what producers and consumers need to know about food and consumer product safety in the age of globalization.
"Readable and well-reasoned, the book is useful not only to those seeking bottom-line information, but to students of modern commercial and trade practices. This book belongs on the shelf of anyone who buys, makes or sells food or anything else, for that matter. Well worth the investment both of time and money."
Monday, November 19, 2007
New Dietary Supplement Adverse Event Reporting
New dietary supplement requirements went into effect December 22, 2007, requiring new reporting and recordkeeping for adverse events associated with dietary supplements. You may read more about the requirements in the FDA draft publication:
Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act Draft Guidance (Oct. 2007) available at: http://www.fda.gov/OHRMS/DOCKETS/98fr/07d-0388-gdl0001.pdf.
Wednesday, October 10, 2007
Law and Self-Regulation: Sugar-Sweetened Beverage Sales in Schools
Michelle M. Mello et al., American Journal of Public Health (free abstract) http://www.ajph.org/cgi/content/abstract/AJPH.2006.107680v1 (as of 10/10/07)
Study examines laws and industry self-regulation of sugary drinks in schools.
Wednesday, October 03, 2007
"Hot Topics in Food Law"
The program hits a number of Hot Topic issues in the emerging area of Food Law, including litigating food contamination cases, class actions regarding labeling, allergens in food, and new food technologies, including cloning and genetic engineering.
If you are new to this emerging area and want an introduction to hot topics in Food Law, this is a great program. Even if you are a season veteran in Food Law and Litigation, this program will quickly update you on the newest and hottest issues.
Don’t let your Food Law knowledge go stale! The registration link is below, and a PDF detailing the program is attached.
http://meetings.abanet.org/aba_timssnet/Meetings/tnt_meetings.cfm?action=long&primary_id=CET7HTI&webtextid=31300&Subsystem=MTG&related_prod_flag=0
Prof. Roberts on Role of Regulation in Minimizing Terrorist Threats
Michael T. Roberts (Venable LLP, Professor at IFLR, teaching Food Regulation in Asia) has published The Role of Regulation in Minimizing Terrorist Threats Against the Food Supply: Information, Incentives, and Penalties, 8(1) Minn. J. L. Sci. & Tech. 199-223 (2007). The article is posted on the Agricultural Law Center website at http://www.nationalaglawcenter.org/assets/articles/roberts_regulation.pdf. The article begins:
Ringing alarm bells as he announced his resignation as Secretary of the Department of Health and Human Services, Tommy Thompson posited: “I, for the life of me, cannot understand why the terrorists have not . . . attacked our food supply because it is so easy to do.” The seeming ease of a terrorist attack on the United States food supply evokes the obvious question of what steps should be taken to minimize the threat. Determining what steps should be taken and implementing those steps naturally turns our attention to the government’s important role in protecting the safety of the nation’s food supply from terrorist attacks.
Monday, June 25, 2007
FDA Announces Final Rule Establishing cGMPs for Dietary Supplements
June 22, 2007
In a companion document, FDA is also announcing today an interim final rule
(IFR) that outlines a petition process for manufacturers to request an exemption to the cGMP requirement for 100 percent identity testing of specific dietary ingredients. If the manufacturer can provide sufficient documentation that the supplier maintains appropriate in-process manufacturing controls and has consistently produced the dietary ingredient over a period of time, the manufacturer may be exempted from the testing requirement. FDA is soliciting comment from the public on the IFR. There will be a 90-day comment period.
Written comments may be submitted to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852 or on line at:
http://www.fda.gov/dockets/ecomments
Saturday, May 26, 2007
Practice Pointer: Don't Insult the Judge
Thursday, May 17, 2007
We Are All the Mitten State - FDA Preemption and the Lipstick Problem
Professor Henry Greenspan (Psychologist, U Mich) has posted an article on the TortDeform Blog focusing on efforts to make FDA standards preemptive. He presents reasons why FDA regulations should not pre-emption state tort actions (as Michigan law does with drug injury cases—Michigan is the Mitten state). The lipstick problem is the focus on reforming FDA as the means to resolve criticism of FDA preemption of states.
[M]ore central to the issue of FDA preemption, there remains a wide range of potential delinquencies relevant in civil litigation but over which the FDA – even in its most "revitalized" incarnation – has no authority whatsoever. Staying with Vioxx, for example, we learned that there was an orchestrated campaign to threaten and intimidate academic researchers who did not see things the company's way. Tactics like those may profoundly influence what does and does not become known about a drug's safety, but they have nothing to do with whether a company is "in compliance" with FDA regulations. They are not within the FDA's jurisdiction at all.
We have also learned that data may be skewed, even excised, in ways that impact what is published in major medical journals. These are the sources of information upon which physicians rely. Again, however, the FDA has no authority whatsoever over the editorial policies of those journals. Indeed, in a now well known article about Celebrex published in the Journal of the American Medical Association – in which, it turned out, half the data was simply left out – the most seasoned medical reviewer at the FDA, Dr. Robert Temple, noted "when the JAMA article comes out and confirms the hype, that probably has more impact than our labeling does." Unfortunately, even if we had the most "revitalized" FDA imaginable, there would remain very large arenas for potential intimidation, misinformation, and hype.
That is why there is no FDA reform conceivable – and even less what was just passed by the Senate – that would substitute for the accountability that civil liability makes possible. The two systems complement each other; they do not cover the same ground. And that is why, when the FDA preemption gang starts to invoke that bill to suggest that FDA's problems are now solved, we should not be distracted. We should not confuse the pig, when there is one, with the lipstick.
You can read the whole article at: http://www.tortdeform.com/movabletype/mt-tb.cgi/873.
Thursday, May 10, 2007
Gluten factory had a toxic history
By Don Lee and Abigail Goldman
May 9, 2007
XUZHOU, CHINA — Before Mao Lijun's business exported tainted wheat products that may have killed American pets, his factory sickened people and plants around here for years.
Farmers in this poor rural area about 400 miles northwest of Shanghai had complained to local government officials since 2004 that Mao's factory was spewing noxious fumes that made their eyes tear up and the poplar trees nearby shed their leaves prematurely. Yet no one stopped Mao's company from churning out bags of food powders and belching smoke — until one day last month when, in the middle of the night, bulldozers arrived and tore down the facility.
It wasn't authorities that finally acted: Mao himself razed the brick factory — days before the investigators from the U.S. Food and Drug Administration arrived in China on a mission to track down the source of the tainted pet food ingredients.
In the end, Chinese authorities caught up with Mao and arrested him. And Tuesday, after weeks of denials, China acknowledged that Mao's company and another Chinese business had illegally exported wheat and rice products spiked with melamine, a chemical used in making plastics and fertilizers. That chemical is banned in foods in the U.S.
For the rest of the story: http://www.latimes.com/business/la-fi-petfood9may09,1,5484365.story?ctrack=1&cset=true (requires free membership).
Monday, May 07, 2007
Food Safety Hearing
The U.S. House Committee on Agriculture will hold a hearing to review the impact of imported contaminated food and recent food safety emergencies on food safety and animal health systems, at 11:00 a.m. ET on May 9, 2007. The hearing will be held in Room 1300 of the Longworth House Office Building. For more information, visit http://agriculture.house.gov/hearings/schedule.html.
"Panel urges schools to replace junk foods"
Washington Post (04/26/07) Sally Squires
The Institute of Medicine (IOM) has released a report proposing bans on soft drinks, sugary snacks, and other junk foods sold in schools to combat obesity in children. The recommendations, drafted at the request of Congress, were the first to address the issue of “competitive foods,” snacks and drinks often sold to raise money for schools, and which compete with healthier cafeteria offerings. IOM said less-nutritious offerings should be replaced with fruits, vegetables, low-fat dairy products, and whole-grains. The recommendations also suggest that the calorie content of snacks and drinks be limited to no more than 200 per portion, and that schools switch to items that contain no trans fat, lower levels of sugar and sodium, and no more than 35 percent of calories from fat. IOM also suggests a ban on sports drinks, soft drinks, and caffeinated drinks, calling for schools to provide free, safe drinking water or allow students to buy nonfat or low-fat milk or 100 percent juice. J. Justin Wilson, of the Center for Consumer Freedom, called the recommendations “misguided,” warning that the report jeopardizes the classroom birthday party. But “Children eat 30 to 50 percent of their calories at schools on school days,” said Margo Wootan of the Center for Science in the Public Interest. “When parents send their kids to school with lunch money, they don’t want to worry that it will be spent on Cheetos and Gatorade.”
To read the text of the IOM report, Nutrition Standards for Foods in Schools: Leading the Way toward Healthier Youth, visit http://www.iom.edu/CMS/3788/30181/42502.aspx.]
Thursday, March 08, 2007
Food Labeling Workshop
This workshop presents the FDA requirements for food labeling. The workshop format and materials are designed to provide a user-friendly approach for those new to food labeling and also provide a thorough system and reference for those experienced with food label design and review. The workshop format allows time for questions. The focus is practical, and students are encouraged to bring problem labels for hands-on review.
Thursday, February 15, 2007
"The Federal food safety system: A primer"
"The Federal food safety system: A primer"
Congressional Research Service (CRS) (Feb. 14, 2007).
Numerous federal, state, and local agencies share responsibilities for regulating the safety of the U.S. food supply, which many experts say is among the safest in the world. Nevertheless, critics view this system as lacking the organization and resources to adequately combat foodborne illness, which sickens an estimated 76 million people and kills an estimated 5,000 each year in this country. The 110th Congress may face calls for a review of federal food safety agencies and authorities, and proposals for reorganizing them. Among the issues likely to arise are whether reform can improve oversight, and the cost to industry, consumers, and taxpayers. This report provides a brief introduction to the system and the debate on whether reorganization is needed. The report is available at http://opencrs.cdt.org/rpts/RS22600_20070207.pdf
Wednesday, February 14, 2007
Spinach in the Hot Spot: Should We Irradiate Our Food?
Food Irradiation Meeting (3/7). The National Academies of Science will host “Spinach in the Hot Spot: Should We Irradiate Our Food?” on March 7, 2007, in Washington, DC. For more details, visit http://www8.nationalacademies.org/publicmeeting/meetingview.aspx?meetingid=209.