Blog followers

I've added a "gadget" to allow Fresh Talk readers to add their pic and name to the blog. Find it on the right side of the blog. I'll look forward to seeing some of the Fresh Produce Industry Discussion Group and other readers sign in and upload their photo.

Alliance: Change listeria draft guidance for fresh produce

The docket on the draft guidance for control of listeria monocytogenes in Refrigerated or Frozen Ready-to-Eat Foods provoked a comment from an industry alliance Oct. 9. Here is a letter that seeks to recenter the FDA's focus:




October 9, 2008
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane
Room 1061
Rockville, MD 20852
Re: Docket No. 2007-D-0494: Draft Guidance for Industry: Control of Listeria monocytogenes in Refrigerated or Frozen Ready-to-Eat Foods; Availability
Dear Sir or Madam:
On behalf of the Alliance for Listeriosis Prevention (listed at the end of this letter), we are submitting the attached copy of FDA’s “Draft Guidance for Industry: Control of Listeria monocytogenes in Refrigerated or Frozen Ready-to-Eat Foods” with suggested changes marked with “track changes.” Our suggestions incorporate the concepts that have made industry control of L. monocytogenes so successful in many operations and better delineate controls based on product risk (e.g., foods that support growth versus those that do not).
We note in submitting these comments that fresh and fresh-cut produce present a unique set of risks and consequences for controls, compared with other ready-to-eat foods, as noted in the April 7, 2008 comments submitted to FDA by United Fresh Produce Association. Thus, many of the recommendations in the guidance are not appropriate for these products. FDA has already noted the special circumstances of fresh produce in the recommendation for fresh produce companies to refer to the Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables for Listeria controls. The Alliance therefore respectfully suggests that FDA’s guidance also refer fresh-cut operations to the February 2008 Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables as the most appropriate approach for control of pathogens in these products. We welcome the opportunity to have additional discussions on control of pathogens, including Listeria monocytogenes, in fresh and fresh-cut produce. We urge FDA to revise the guidance as outlined in the document to better align it with current industry practices that have been developed and enhanced over many years. If we can provide more information, please do not hesitate to call.
Respectfully submitted,
Craig W. Henry, Ph.D.
Senior Vice President and Chief Operating Officer
Grocery Manufacturers Association

Movement of genetically engineered organisms

The USDA issued a proposed rule and a notice of public meetings on the topic of movement of genetically engineered organisms into the U.S. Find the federal docket here, which describes the effort as the first revisiting of regulations first established in 1987. The agency will take comments until Nov. 24 and also consider input from three public meetings at Davis, Calif., Riverdale, Md. and Kansas City, Mo. The Davis meeting is set for Oct. 28, with Kansas City on Oct. 30 and Riverdale on Nov. 13. Find the 42 page rule at the docket link...

Need a laugh? - Brian Regan and pop tarts

More oversight of swaps and OTC financial derivatives needed

I frankly don't know how "swaps and derivatives" work, but perhaps I should. Here, Sen. Tom Harkin states more regulatory safeguards could be in order and he observes that speculative money is leaving the futures markets, with substantial consequences to grain prices. From the office of Sen. Tom Harkin of the Senate Agriculture Committee:

Senator Tom Harkin (D-IA), the Chairman of the Senate Committee on Agriculture, Nutrition and Forestry, today questioned the influence of swaps and derivatives on the financial markets and the adequacy of federal regulatory safeguards the week before the Committee is set to explore the issue. Harkin has a history of raising these questions with federal officials. At a February 10, 2000 hearing of the Committee, Harkin, in his position as Ranking Member, questioned the risks of deregulating derivatives and asked then- Chairman of the Federal Reserve System Alan Greenspan and then-Secretary of the Treasury Lawrence Summers about the potential threats to the financial system from potentially high risks in trading of swaps and over-the-counter derivatives.

“Financial swaps or over-the-counter financial derivatives had been exempt from most regulations since 1993. Mainly that meant they did not have to be traded on fully regulated futures exchanges,” said Harkin. “I firmly believe we have to revisit and examine very carefully how these financial swaps and derivatives are regulated – or really not regulated. That is the purpose of my hearing on Tuesday -- to dig into these issues and get some answers. The questions I asked in 2000, and before actually, are still pertinent.

“Clearly, more oversight and regulation of these markets is needed. Swaps and derivatives function in many respects like futures contracts traded on exchanges regulated by the Commodity Futures Trading Commission,” continued Harkin. “For that reason, the Senate Agriculture Committee hearing will explore the scope of CFTC's authority under existing law and whether this authority is adequate in the wake of the current financial crisis.”

Derivatives are financial instruments theoretically intended to limit risk and ward off financial problems. But with some doubts in the market as to how companies would value them, derivatives have created uncertainty and have increased risk. According to a report in The New York Times today, the derivatives market includes contracts and instruments valued at some $531 trillion, up from $106 trillion in 2002 and a relative pittance just two decades ago.

It is now clear that the impact of the financial contagion is spreading to other markets. Agricultural commodity futures prices, especially for grains and oilseeds, have fallen sharply in recent days, and commentary from the U.S. Department of Agriculture detailed in media reports suggests that is not because of substantial new developments in global crop production but is in response to the financial situation and money exiting the futures markets.

The Senate Agriculture Committee will meet in open session at 9:30 A.M. on Tuesday, October 14, 2008 in Room 106 of the Dirksen Senate Office Building to explore the role of derivatives in the current financial crisis and examine regulatory issues pertaining to them. More information about the hearing and Committee action can be found here: http://agriculture.senate.gov/.

Will PMA show be hurt by sliding economy?

That's a question that has come up in the last few days, and the consensus by most is that it won't likely have a big effect.

Will there be an "11th hour" swoon in attendance, given the turmoil in financial markets?

Bryan Silbermann of PMA said show registration numbers rivaled those of the PMA show in San Diego two years ago. While there may be fewer walk up, on-site registrations this year, Silbermann said signs point to another strong show and no big drop off in attendance.

Looking farther down the road, this softer economy will surely impact the way companies use their travel budgets.

I noticed that PMA has advertised in a recent issue of The Packer that they did not raise their membership dues this year. Going forward, all associations and every industry company marketing a good or service will surely look to deliver value to their customers or pay the price themselves.

Here is some recent coverage about how businesses are adjusting to the recent turmoil:


Economy takes toll on premium airline passengers From the WSJ:

Until earlier this year, Stephen Terrell, a 45-year-old executive with an Atlanta insurance-settlement company, regularly flew business class for work-related travel to New York, California, Florida and the Midwest. But as the financial sector began to unravel in recent months, his employer, which this week laid off nearly half its 50 employees, began booking only economy-class seats. "We're only traveling when it's absolutely necessary," Mr. Terrell says.


Central Florida feels effects of economic slump From The Orlando Sentinel

August occupancy in Metro Orlando hotels dropped 1.2 percent from the previous year, and September is expected to be worse, McHugh said. Potential convention bookings are down 8 percent compared with last year, while locked-in convention bookings are off by 23 percent, figures show.

Las Vegas strip revenue declines for eighth straight month From Bloomberg:

Casino revenue at the largest U.S. gambling center fell 6.7 percent to $4.21 billion this year through August as U.S. consumers struggled with higher gasoline and food prices, declining home values, job losses and the worst financial crisis since the Great Depression.


U.S. hotel industry posted declines last week From AP

"While the impact from Rosh Hashanah was felt last week, the major concern over the bailout of the U.S. economy crippled the weekly results across all industry segments," said Brad Garner, STR's vice president of client services.

Garner said twenty of the 25 largest hotel markets experienced a double-digit decline in revpar growth over the same week last year.

"A significant pullback in business travel, a collapse in discretionary leisure travel and continued group attrition rates will be ongoing concerns until the credit market crisis eases," Garner said.

Regulations: never ceasing to amaze

Here are a couple of new regulations coming down the pike.....

Requirements for antimicrobial pesticides Comments due Jan. 9, 2009
Another level of rulemaking requirements planned by EPA

Implementation of Revised Lacey Act Provisions Comments due Dec. 8, 2008
This rule imposes new requirements on import declarations for certain plants and plant products. One fed up commenter, John DeMott of Redland Nursery already had this to say about the rule:

It never ceases to amaze me the freedoms we are losing by subscribing to the Socialistic regulations imposed by international Law. These regulations are devastating to free trade not only on a global level but more and more on the national, trade between states. Each State seems to be implementing more and more restrictions in the movement of Agriculture products.If APHIS (Regulatory, Licensing, and taxing) were on the stock market this is where I would put my 401. It has to be the biggest branch of the USDA. It seems to be poised for nothing but future growth, while the ARS (Science and Research) is continually scraping for funding.

Imports of Chilean oranges - methyl bromide objection

The federal docket on the proposed rule that would allow imports of Chilean oranges and grapefruit is generally drawing support from U.S. companies, but this comment from the public indicates that the continued use of methyl bromide - even as a backup to the systems approach - grates against the sensibilities of those who want to see the end of all uses for the ozone-depleting fumigant. From the docket, a comment from Stephanie Bostic:



I am highly concerned about the use of methyl bromide as a fumigation technique for citrus fruit being imported from Chile to the US. While I fully support all efforts to prevent the entrance of pests such as the medfly into domestic crops and wildlife areas, the use of methyl bromide concerns me.Methyl bromide was supposed to be phased out around the world due to its highly destructive impact on the ozone beginning in 2000, per the Montreal Protocol. I have been horrified to see the US’s abuse of the “critical-use” exemptions. This rule would be a furtherance of that attitude: requiring another country to use a chemical that we should not be using.Methyl bromide is extraordinarily effective at destroying the ozone layer which protects all life from UV-B rays. It is responsible for as much as 15% of the loss. The ozone plays a vital role in protecting the Earth’s ecosystems, and disrupting it is also contributing to problems like climate change.In addition, methyl bromide, like most pesticides, can have a harmful effect on the workers administering it. Particularly in a less developed nation, where occupational health and safety standards may not be as high, the dangers of acute and chronic poisoning should be considered. Methyl bromide has been shown to damage the neurological system, the lungs, the heart, and kidneys. While it is not carcinogenic, it takes around 12 days to be excreted from the body, so a build-up of the chemical can lead to a sudden onset of toxicity.Alternatives range from heat/cold treatments to other chemicals and irradiation. The EPA has done extensive research and compiled easily accessible reports on alternatives.

Unless a fumigation method other than using methyl bromide is adopted, I cannot support this rule, or the importation of citrus fruit from Chile.

Stephanie Bostic
M.S. candidate in Agriculture, Food, and the Environment

PMA comment - product tracing systems for fresh produce

Related to recent news about the Produce Traceability Initiative, this comment from PMA was added yesterday to the federal docket on product tracing systems for fresh produce.

October 8, 2008

To: U.S. Food and Drug Administration/Center for Food Safety and Applied Nutrition http://www.regulations.gov

From: Produce Marketing Association

Kathy Means, Vice President of Government Relations and Public Affairs

Subject: Docket No. FDA-2008-N-0513, Product Tracing Systems for Fresh Produce

The Produce Marketing Association (PMA) is pleased to submit these comments to U.S. Food and Drug Administration (FDA) regarding the agency’s request for comments on product tracing systems for fresh produce.

PMA is the largest global not-for-profit trade association representing companies that market fresh fruits and vegetables. We represent 3,000 companies from grower-shippers and supermarket retailers, to hotel and restaurant chains and overseas importers. Within the United States, PMA members handle more than 90 percent of fresh produce sold to consumers. PMA and our members are committed to improving food safety practices for produce, both domestic and imported, to further enhance the safety of our food supply.

We have been actively engaged in developing and implementing produce industry standardization practices – including produce traceability since 2002. We have worked closely with FDA, the U.S. Department of Agriculture (USDA) and other state and local agencies as a source of industry information and technical inputs, and as a supporter of the agencies’ roles in assuring public health. In addition to our comments here, we call FDA’s attention to the Produce Traceability Initiative (PTI) referenced in the request for comments. The PTI has just announced its plan for achieving chain-wide, electronic traceability for produce, to enhance the industry’s current traceability capability. That plan was developed over a lengthy, thoughtful, and intensive process by the PTI’s multidisciplinary steering committee to ensure that plan is achievable across the produce supply chain, from field to store to foodservice.

We strongly urge the agency to consider the PTI’s work and plan before taking any further steps on this topic, as these produce industry experts are in the best position to make recommendations that are realistic and achievable in the marketplace – and a significant number of produce industry members have already agreed to implement the PTI plan. We have relied heavily on the PTI’s plan in our comments below.

The PTI recommends that all companies involved in marketing produce within the U.S. market adopt a common standardized approach to identify produce cases, allowing for streamlined marking and consistent identification for each case of produce, scanning and collection of case data by all buyers, receivers and handlers, and electronic storage of such information to allow for timely and efficient recovery in the event of tracebacks or recalls.

This includes all companies operating within the U.S. market and those exporting to the United States. Implementing this standardized systems approach across the entire industry will require a multi-year transition effort, at an investment of hundreds of millions of dollars. This PTI is led by the industry’s major trade associations to standardize the broad adoption of state-of-the-art processes across the industry. This work will maximize the effectiveness of industry’s current traceability procedures, improve our internal efficiencies, and assist the agency greatly in its work.

The PTI endorses an industrywide commitment to case identification based on GS1 standards for the effective management and control of supply chains. GS1 is a global standards organization with affiliates representing 145 countries worldwide in more than 25 industries with a membership in excess of 2 million.

The GS1 System provides standard protocols that help uniquely identify trade items (products and services), logistic units, locations, assets, and service relations worldwide. The Steering Committee recommends that the produce industry universally adopt the use of the GS1 Global Trade Item Number (GTIN) and the incorporation of its associated lot or batch number into the bar code on the case. This GTIN is analogous to the UPC used at the item level. What the UPC does for item level identification, the GTIN does for case level identification. Both numbering protocols are managed by GS1. The systematic use of GTIN identification numbers at the case level will enhance total produce supply chain traceability by allowing direct standardized interaction between differing internal coding systems that are unique to each company.

FDA posed several questions, addressed below:

1. Should a "fresh produce identifier" be assigned to fresh produce? If so, at what stage or stages in the supply chain should such an identifier be assigned or modified? What data or information would be useful to include in such an identifier? Should the identifier be placed on the fresh produce, the package, the shipping container, and/or the invoice or bill of lading? Should the location of the identifier depend on the type of produce or on other factors?

Yes. At the heart of the GS1 numbering system recommended by the PTI is the requirement that each “brand owner” obtain a unique GS1-issued company prefix, which allows for unique identification of products from that company. This company prefix will then become part of all GTINs assigned to cases of produce from that company, and immediately serve to identify the “brand owner” of that product throughout the supply chain. Companies that repack produce into a new container or alter the case configuration or makeup of the product inside in any way, will become the new “brand owner” and thus will also need to obtain their own unique company prefix.

Each company moving product into commerce should have a unique company prefix as part of the Global Trade Item Number (GTIN).

Brand owners must then assign specific 14-digit GTIN numbers to all of their various case configurations based on the combination of their company prefix and a reference number. This reference number is used to identify various attributes of the case and of the produce inside the case. It is highly recommended that companies use the GTIN Assignment Strategy provided by industry associations as a guide to allow for consistency across the industry. In addition to the GTIN, the lot or batch code is also incorporated into the bar code on the case.

2. What other data or information would be useful on the invoice or bill of lading, fresh produce, package, or shipping case? At what stage or stages in the supply chain should such data or information be included?

The GTIN is a 14-digit code used to identify shipping containers. The data contained in the GTIN along with its associated lot or batch number in the bar code is sufficient to provide the one-up, one-back information that FDA desires and that is required by the Bioterrorism Act. Each link in the distribution chain must record and store the information. By following those links, the logistical history of the products can be traced effectively and quickly. This information should be provided on the case in both a bar code and a human readable format.

3. Should an enhanced product tracing system extend to all fresh produce? If not, what criteria should be used to determine coverage?

We recommend that all fresh produce marketers throughout the supply chain implement the recommendations in the Produce Traceability Initiative.

4. Should fresh produce be commingled? If commingling is unavoidable, what practices should an enhanced product tracing system include to ensure that fresh produce can be traced effectively and efficiently?

The PTI provides for linkage between product that comes into a facility and is repacked into a different configuration, possibly commingled. Companies that repack produce into a new container or alter the case configuration or makeup of the product inside in any way, will become the new “brand owner” and thus will also need to obtain their own unique company prefix. They would assign a new GTIN to the new, repacked case, showing themselves as the “brand owner” and assign a new lot or batch number – giving the case a new bar code. And they would have information systems/programs that can link the repacked product to the product that came into the facility originally. This ensures the one-up, one-back link is not broken.

5. What should be the scope of an enhanced product tracing system for fresh produce?

The PTI calls for all links in the supply chain to be engaged – whether coding cases or recording and storing the information from the code. This is what ensures the one-up, one-back information chain. At this point, the PTI seeks to enable greater labeling efficiencies at the case level, which would not be seen or recorded by consumers. Some produce items are identified at the item level (e.g. bags of salad). Eventually, identification at the item level – that which the consumer would see and take home – may be more pervasive. At this point, we recommend implementation of case-level identification.

6. Should the data or information in an enhanced product tracing system be human-readable, technology-based, or both? If technology-based, what technology should be used?

We recommend both a bar code and a human-readable format for these case codes.

7. What (if any) data or information in an enhanced product tracing system should be standardized?

We refer the agency to the PMA-CPMA Fresh Produce Traceability: A Guide to Implementation (provided previously in hard copy or found at http://www.pma.com/cig/tech/traceability.cfm) for recommendations on standardized coding.

8. What are the costs, benefits, and feasibility of implementing an enhanced product tracing system?

The costs will vary depending on each company’s existing readiness, but it will require significant investment on the part of industry – a multi-year process costing hundreds of millions of dollars. The benefits are increased efficiency for the one-up, one-back traceability process. Some companies with sophisticated systems and resources may move more quickly. Others may be starting from scratch or may need to make significant changes in their business processes.

9. Would enhancing FDA's role in developing and implementing effective product tracing systems for fresh produce, through increased regulation, guidance, or additional legal authorities, improve the effectiveness of traceback investigations and traceforward operations? What mandatory and voluntary measures would be most effective in achieving the goal of enhancing product tracing systems for fresh produce and improving FDA's ability to use the information in such systems to identify the source of contamination associated with fresh produce-related outbreaks of foodbome illness? How would these measures help FDA work better with industry and other stakeholders during traceback investigations and traceforward operations?

The industry has taken significant steps to move forward with the PTI. The produce industry is committed to effective and timely capability to track the source of our products from retail stores and restaurants back to their original farm source.

The Bioterrorism Act requires mandatory one-up, one-back record-keeping of all foods, with the ability to provide such records within 24 hours. The industry is committed to full compliance with these requirements, and urges FDA to rigorously enforce the requirements of this law. The produce industry stands ready to work with the agency to ensure full and total compliance with these requirements.

Without widespread and effective enforcement of the current law, we oppose any additional mandatory legislative or regulatory requirements for traceability as premature and unwarranted.

We thank the agency for this opportunity to provide comments on this critically important matter. We look forward to working with the agency in any way that is helpful. Please call on us at any time.

Truck rate report - Oct. 7

Many truck rates slide lower from Calif. shipping points this week. From the Oct. 7 USDA Truck Rate Report:


A shortage of trucks was reported for the following commodities and regions: onions from Idaho and Malheur County, Oregon and potatoes from Northwestern Washington. A slight shortage of trucks was reported for the following commodities and regions: potatoes from Upper Valley, Twin Falls-Burley District Idaho, potatoes and onions from Columbia Basin Washington. A slight surplus of trucks was reported for the following commodities and regions: potatoes from San Luis Valley Colorado. A surplus of trucks was reported for the following commodities and regions: sweet potatoes from Atwater Livingston California, carrots and grapes from Kern District California, pears from Sacramento & San Joaquin Valley California, apple pears, grapes, nectarines, melons, peaches, peppers, plums and apples from San Joaquin Valley California, citrus, bell peppers, strawberries and avocados from South District California, citrus, avocados, mangoes and mixed vegetables from Mexico Crossings Through Texas and watermelons from Texas. North and East Points Colorado noted an adequate supply of flatbed trucks and a slight shortage of refrigerated trucks. LAST REPORT was issued for blueberries and celery from Michigan. FIRST REPORT was issued for mixed vegetables from South Georgia and potatoes from Minnesota-North Dakota (Red River Valley). All other districts reported an adequate supply of trucks.