College visit and waiting emails

Just got back from a 30-hour trip to Kearney, Neb. , a high mileage excursion designed for the purposes of checking out the college with our 16 year old daughter. Kind of a nice small college town feel, I must say, plus it is close to grandma and grandpa.

Meanwhile, back to business. Tonight as I check my e-mail I see that it again has filled up with offers from online pharmacies(Just one bottle of HGH Life™ will completely change your life!), penny stock tips (Get IN Before the rush TOMORROW) and bogus messages from my nonexistent paypal account(In order to safeguard your account, we require that you confirm your banking details.)

It seemingly does no good to mark these email as spam. They just keep coming and coming.

So I was pleased to find some bona fide produce related emails among the offers for online meds. Amy Philpott send Jim Gorny's testimony at the March 20 FDA hearing. Find it here.

The statement of Joel Nelsen before the Senate Agriculture Committee on March 21 is published here.

Nelsen makes some key points about trade issues:
Here are some excerpts:


U.S. international trade policy is critically important to the U.S. specialty crop industry.
Unlike many of the other agricultural crops, fruits and vegetables face a significant trade imbalance with our trading partners. Between 1995 and 2005, imports of fruits and vegetables into the U.S. more than doubled, to $10.1 billion in 2005, while U.S. exports have increased much more modestly. As a result, the fruit and vegetable trade surplus in 1995 of over $600 million is now a trade deficit of nearly $2.3 billion (see Attachment 1). This trade deficit of $2.3 billion is a manifestation of the many difficulties that specialty crop growers now confront in their efforts to remain competitive in global markets:

Later...

One of the primary reasons for the $2.3 billion trade deficit in specialty crops, which of course contributes significantly to the total U.S. trade deficit, is that access to foreign markets for U.S. specialty crops has often been blocked due to phytosanitary trade barriers. In May of 2005, a report by USDA’s Foreign Agricultural Service, which was mandated by the enactment of the Specialty Crop Competitiveness Act of 2004, identified 36 different phytosanitary barriers that serve as obstacles to specialty crop exports in various international markets. While some of these phytosanitary issues are of legitimate concern, many are not justified with sound science. It is imperative that the 2007 Farm Bill address the problem of phytosanitary trade barriers, which is a major problem of specialty crop growers.
CCM and the Specialty Crop Farm Bill Alliance believe that we should immediately accelerate efforts to increase exports through the removal of phytosanitary barriers by increasing TASC funding in the 2007 Farm Bill to meet demand. We recommend that the existing level of $2 million per year in mandatory funding be increased to $10 million per year (a phased increase of $2 million increments per year).

CCM and the SCFBA believe that increased coordination between all federal agencies that are responsible for agricultural trade matters would help increase the likelihood for success in removing phytosanitary trade barriers. We therefore recommend that language be included in the 2007 Farm Bill that will require or encourage key agencies, such as USDA and USTR, to work toward increased coordination of export trade objectives and greater transparency on phytosanitary issues.



TK: Nelsen finishes strong, with recommendations that the USDA develop a Threat Identification and Mitigation Program that "clearly identifies and prioritizes foreign invasive species threats to the domestic production of specialty crops." He also wants the next farm bill to contain language that directs the Secretary of Agriculture to access Commodity Credit Corporation funding for emergency response and eradication programs for invasive pests. Finally, he asks that border inspectors again be the responsibility of USDA APHIS and not Customs and Border Protection.

Hopeful on immigration

The Fresh Talk poll indicates 66% of the very slim pool of respondents believe immigration reform that accounts for agriculture can be accomplished this year.

Next poll question: Who is the most effective advocate for the produce industry in Congress? To be posted tomorrow.

Environmental tradeoffs

Fresh Express is in the news again relating to its buying standards, this time with coverage focusing on the environmental tradeoff of its buying requirements. Here is coverage of the story by Jacob Adelman of the AP:
From the story:

Trying to prevent more E. coli outbreaks and regain consumer confidence, some produce distributors are pressuring farmers to abandon practices that have long been considered environmentally friendly. Fresh Express, the nation's No. 1 maker of packaged salads, is refusing to buy lettuce and spinach from farmers who don't stop using compost and recycled water. Farmers complain that they are being subjected to requirements based more on conjecture than sound science, and that the mandates could undo years of work aimed at making farming less disruptive to the environment.
''There's been some real knee-jerk decisions made in the industry,'' said Dirk Giannini, who operates a lettuce farm in the agriculture-rich Salinas Valley. ''We may overreact, and that might shortfall the environment.''

Not all distributors are adopting the stringent policies regarding farm practices. Will Daniels, food safety chief for Natural Selections LLC, which also distributes packaged produce, said there wasn't enough evidence linking compost use and non-crop growth on farms to the spread of E. coli. "It's difficult to put blanket statements out there to say, 'There will be no use of grass for erosion control,'" he said.

Distributors have until April 1 to sign a statewide self-regulating agreement coordinated by the Western Growers Association, which represents the fresh produce industry in California and Arizona. The most recent draft of the plan would prohibit deals with farmers who use raw manure as fertilizer and allow livestock near crops, among other practices.

Farmer George Fontes said companies have already stopped buying lettuce grown on his Salinas farm using compost that sometimes contains manure.
''There's no real proven connection between contamination and compost,'' he said.
Fontes believes that using compost instead of chemical nutrients is better for the long-term health of his fields. Fertilizer can harm nearby waterways because runoff contains nitrogen and other elements that promote algae growth and decrease oxygen, killing fish, he said.

TK: Taking away the use of compost may seem like a Draconian measure to some consumers, who may finally see in these tradeoffs the cost of reducing food safety risk.

The case for regulation

The consumer group Consumers Union gave testimony at the FDA hearing in Oakland yesterday. Here is the link to the testimony of Elisa Odabashian, West Coast director of Consumers Union.

Some excerpts:

I appreciate today’s opportunity to participate in this public conversation with the FDA about the safety of fresh produce. You have heard today from a number of scientific experts from government and industry about all that has been done and is being done to ensure the safety of fresh fruits and vegetables, much of which is grown in California.

I’ve been asked to give you the consumer perspective. That perspective is currently worth $100 million—that’s $100 million in lost revenue to the California leafy green industry in just the last five months alone because last September more than 200 unlucky consumers across 26 states ate spinach contaminated by a particularly virulent form of E. coli (0157:H7) that killed as many as five, hospitalized more than 100 and sickened another 100. This spinach disaster was quickly followed by a Salmonella outbreak from contaminated tomatoes served at a restaurant, which sickened 183 people in 21 states. On the heels of this came another E. coli outbreak from shredded lettuce at Taco Bell and Taco John Restaurants that sickened 152 individuals.

At this moment all across America, the consumer perspective is one of deep disappointment in government agencies, both at federal and state levels, that have failed to safeguard the food supply, deep distrust in the leafy green industry that is responsible for two dozen food-borne illness outbreaks in the last ten years, and confusion about whether fresh vegetables and fruits are the most healthful foods to eat or whether they’re potentially deadly.

There is only one way to ensure that all fruits and vegetables that reach the marketplace are safe, only one way to rebuild consumer confidence—FDA or the California Department of Health Services, separately or in conjunction, must assume the authority and be given the staff to effectively mandate Good Agricultural Practices (GAPs) for every farm and Hazard Analysis Critical Control Point (HACCP) programs for every processor, including thorough and regular inspection programs, effective trace-back systems, third-party audits, and rigorous enforcement of standards.

In California, the California Department of Food and Agriculture (CDFA) in partnership with the leafy green industry, is furiously pushing forward a marketing agreement to develop voluntary Best Practices standards. This is being done behind closed doors without any public input.

By its very nature, a voluntary program of safety standards does not account for the bad actors and does not ensure that all products that come to market are safe. Nor do voluntary standards create an incentive for everyone to comply, particularly when meeting safety standards costs money. If not all producers and processors are subject to the same standards, the door remains open for contaminated produce to reach consumers, with all the attendant negative public health effects, publicity and economic impact that that incurs.

Another bad idea that has come out of California’s industry-driven marketing agreement is the use of a certification mark to convey to consumers that leafy green products from participating farms and processors in California are subject to Best Practices. This approach turns safety into value-added in the marketplace. The safety of the food we buy is a fundamental expectation of consumers, and government must ensure it. Safety should not be used as a marketing tool when it comes to food; it should not be something that consumers must search out and possibly pay extra for, leaving poor consumers at risk.

I leave you today with a couple of $100 million questions from the consumer perspective:
1) Why is the FDA only “suggesting” and “recommending” safe practices for the fresh produce industry, and not requiring them, despite numerous incidences of contaminated fresh produce reaching the marketplace and harming, even killing, consumers?
2) How many more deadly outbreaks must there be before FDA’s should becomes a must, and their “suggestions, recommendations and current thinking” become rigorous, mandatory oversight by a credible government watchdog that is well-funded and adamant about protecting the food supply and public health?
Consumers are sitting on their pocketbooks, waiting for the answers.

TK: It is virtually impossible for the FDA (and California's marketing agreement) to come out looking good in the way this argument is framed. Although the industry is more comfortable with the concept, consumers and the press can't make the mental leap required to understand that FDA guidance equals oversight.

No answers!

This is extremely disappointing. The FDA and state officials said at a hearing Tuesday that they likely will never know the exact cause of bacterial contamination that was linked to spinach last year.
Here is a link from the San Jose Mercury that gives a report of the FDA hearing in Oakland.
From the story:

The disclosure, just weeks before a final report on the investigation is expected to be released, came at a hearing where representatives from consumer groups and a national trade association for the produce industry called on the U.S. Food and Drug Administration to set mandatory rules to assure that fruit and vegetables are safe to eat.
FDA and state health officials, however, said they favor voluntary guidelines and industry self-policing, including a set of standards that California growers are expected to adopt next week. The government officials said they would not rule out mandatory regulation in the future.
Growing and packing practices need to improve said Dr. David Acheson, the chief medical officer for the FDA's food safety office.
But he also warned that another outbreak of food-borne illness will likely occur.


TK: What will happen when another E. coli outbreak occurs? Even though the FDA is clearly trying to prepare the public for that possibility, the heightened awareness of the media and consumers to foodborne illness outbreaks raises the stakes for the industry and increases pressure on the FDA for mandatory regulation.

Annual burden hours

The US. Food and Drug Administration on March 13 put out notice asking for comments on the draft final guidance, the "Guide to Minimize Food Safety Hazards for Fresh-Cut Fruits and Vegetables"

From the notice:

Currently, the fresh-cut trade association estimates that there are 250 fresh-cut plants in operation in the United States. While most of the recent growth in the fresh-cut industry has been due to mergers between already existing firms, there are approximately 50 fresh-cut plants that did not exist in 2001. This implies that about 10 new firms are entering the fresh-cut industry each year. Many of the existing firms in the fresh-cut industry already make use of CGMP-related, recall, HACCP, and other activities. FDA estimates that the burden of this draft final fresh-cut guidance will fall on both existing and new firms entering the industry who may follow the recommendations in the guidance.


More from the notice:

A typical fresh-cut processing plant operates about 255 days per year. For an 8-hour shift, assuming the ingredients are received twice during that time, under the recommendations in the draft final guidance, there would be about 13 records kept (2 for inspecting incoming ingredients; 2 for inspecting the facility and production areas once every 4 hours; 3 records for equipment (maintenance, sanitation, and visual inspections for defects); one for calibrating equipment; 2 temperature recording audits (1 time for each of the 2 processing runs); and 3 microbiological audits (ingredients, food contact surfaces, and equipment)). Therefore, the annual frequency of recordkeeping for SOPs and SSOPs is calculated to be 3,315 times (255 x 13) per year per firm; 110 firms will be performing these activities to generate a total 364,650 records (3,315 x 110) annually, assuming all firms choose to follow the recommendations on keeping records. The total time to record observations for standard operating procedures and sanitary standard operating procedures maintaintenance is estimated to take 4 minutes or 0.067 hours per record, and the number of records maintained is 364,650. Therefore, the total annual burden in hours for 110 processors to maintain their SOP and SSOP records is approximately 24,432 hours.

TK: The FDA says that summing up all the requirements, the estimated one-time record keeping burden for firms that choose to follow the recommendations is 18,700 hours; the annual burden for firms, existing and new, is estimated to be 41,605 hours. That's a nifty $832,100 at $20 per hour. The cost of consumer confidence?