FoodTRACE and the Food Bill - In Sync!

THE food bill, HR2749 has completed it's review and markups in committee and will be headed to the house floor soon for a vote. FoodTRACE was easily fully compliant with the bill BEFORE the markups and the reduction of restrictions that were in the original draft --- so now the FoodTRACE program EXCEEDS all aspects of the bill as it is currently written. Companies will be able to be in compliance through FoodTRACE at the minimal monthly price level indicated in our program which you can see on http://www.usfoodtrace.com/, under US FoodTRACE program. Basically the parameters are that any company with sales OVER $100 MILLION annually will pay the maximum amount of $1,000/month....and companies UNDER $5 MILLION annually will pay the lowest amount, $100/month. No extras, no additional charges, nothing..... VERY affordable for all size companies with NO intrusion into your systems --- No software to buy...No hardware to buy... No numbers to buy....No additional personnel needed...No data syncronization to buy....No additional annual fees....No set up fees...plain and simple pricing for the most effective traceability option available.

Read the bill ---- It DOES affect every company in the United States. The MAJOR focus of the traceability area has been highlighted in red.

SEC. 107. TRACEABILITY OF FOOD.
(a) Prohibited Act- Section 301(e) (21 U.S.C. 331(e)) is amended by inserting ‘, the violation of any requirement of the food tracing system under section 414(c);’ before ‘or the refusal to permit access to or verification or copying of any such required record’.
(b) Imports- Section 801(a) (21 U.S.C. 381(a)) is amended by inserting ‘or (4) the requirements of section 414 have not been complied with regarding such article,’ before ‘then such article shall be refused admission’.
(c) Product Tracing for Food- Section 414 (21 U.S.C. 350c), as amended by section 106, is amended--
(1) by redesignating subsections (c) and (d) as subsections (d) and (e), respectively; and
(2) by inserting after subsection (b) the following:
‘(c) Tracing System for Food-
‘(1) IN GENERAL- The Secretary shall by regulation establish a tracing system for food that is located in the United States or is for import into the United States. Such regulations shall require each person who produces, manufactures, processes, packs, transports, or holds such food-- ‘(A) to maintain the full pedigree of the origin and previous distribution history of the food;
‘(B) to link that history with the subsequent distribution history of the food;
‘(C) to establish and maintain a system for tracing the food that is interoperable with the systems established and maintained by other such persons; and‘(D) to use a unique identifier for each facility owned or operated by such person for such purpose, as specified under section 911.
‘(2) INFORMATION GATHERING- ‘(A) TRACING TECHNOLOGIES- Before issuing a proposed regulation under this subsection, the Secretary shall--
‘(i) identify technologies for tracing the distribution history of a food that are, or may be, used by members of different sectors of the food industry; and
‘(ii) to the extent practicable, assess--
‘(I) the costs and benefits associated with the adoption and use of such technologies;
‘(II) the feasibility of such technologies for different sectors of the food industry; and
‘(III) whether such technologies are compatible with the requirements of this subsection.
‘(B) PUBLIC MEETINGS- Before issuing a proposed regulation under this subsection, the Secretary shall conduct not less than 2 public meetings in diverse geographical areas of the United States to provide persons in different regions an opportunity to provide input and information to the Secretary.‘(C) PILOT PROJECTS- The Secretary shall conduct 1 or more pilot projects in coordination with 1 or more sectors of the food industry to explore and evaluate tracing systems for food.
‘(3) ADDITIONAL AUTHORITY- In establishing a tracing system for food, the Secretary shall require--
‘(A) the establishment and maintenance of such additional information, including lot numbers, as the Secretary deems appropriate;‘(B) a standardized format for pedigree information; and
‘(C) the use of a common nomenclature for food.
‘(4) EXEMPTIONS-
‘(A) DIRECT SALES BY FARMS- Food is exempt from the requirements of this subsection if such food is--
1‘(i) produced on a farm; and
‘(ii) sold by the owner, operator, or agent in charge of such farm directly to a consumer or restaurant.
‘(B) OTHER FOODS- The Secretary may by notice in the Federal Register exempt a food from the requirements of this subsection if the Secretary determines that a tracing system for such food is not necessary to protect the public health.
‘(C) PREVIOUS SOURCES AND SUBSEQUENT RECIPIENTS- For a food covered by an exemption under subparagraph (B), the Secretary shall require each person who produces, manufactures, processes, packs, transports, or holds such food to maintain records to identify the immediate previous sources of such food and its ingredients and the immediate subsequent recipients of such food.

"Welcome to the End of Traceability Confusion"

Over the last year members of the FoodTRACE team have had the opportunity to visit numerous facilities in various phases of the produce industry. We have been to grower/shippers, consolidators, terminal markets, foodservice operations, retail operations and processors of varying sizes.

One of the purposes for the visits, in every case, was to determine various companies current capabilities when it came to traceability. Every single company that we visited was capable of tracing a product in their system both forward and backwards (one-step-up, one-step-down) as required by the Bio-Terrorism Act of 2002. Most were capable of doing that in under 15 minutes but certainly all were more than capable of doing it within the requirments of the act of 24 hours. Two shippers, in tracing back to the grower, were able to also identify indepth to the crew and time of day that the product was packed. One traceback even went to a grower location, crew and time frame in Mexico.

This reaffirms our consensus that traceability is well entrenched in many companies currently. What is lacking is the full pedigree accessibility as is being discussed in the Food Enhancement Act of 2009, now being discussed in Congress. For example, although many of "links" in the flow of a product might be able to access the traceability in minutes, being able to see the whole picture, both backwards and forwards, is what would really make traceability complete. This is what FoodTRACE offers as only a part of its benefits to members.

The true effectiveness of any program, ours included, is the level of participation. That is why the cost structure has been developed so that literally EVERY facility as defined by the government could afford our program. It is designed so that the smallest of companies can pay as little as $100 per month for ALL of the benefits of the FoodTRACE program. There are NO other expenses, we simply require companies take the data they currently already have, in the format they already use, in tracking their one-step-up, one-step-down information, and electronically transmit that to us.

If a company is so small that all of their reporting is on paper only, FoodTRACE will even provide a computer!

Although the more facilities that register certainly provide more of the full pedigree traceability, each company, as soon as information is being provided, is under the FoodTRACE umbrella and FoodTRACE will monitor any potential problems reported at a government level and companies will know if they need to be aware or if they are not implicated in any potential event. That is only one of the benefits provided by FoodTRACE. To see additional benefits and features of the program, please visit http://www.usfoodtrace.com/ or email us any questions you may have to info@www.usfoodtrace.com.

While there is certainly NO legal requirement for any company to do anything OTHER than follow the Bio-Terrorism Act of 2002 at this time, all facets, features, nuances and concepts being discussed in Congress are all currently covered by the FoodTRACE program and more.

Food Safety Enhancement Act of 2009

This appears to be the bill that will make it through Congress. I'm copying the summary points here but you can view the entire bill at the link below. There have been initial hearing and the bill will be discuss, questioned, changed, and updated starting next week and it is the hope of the committee that it will be voted on this summer, relatively quickly.
The traceability section, #107, is one of the areas that will have some discussion. We will point out to you that every single concept, nuance, intention, and manner in which this bill is written is easily capable of being managed by the USFoodTRACE program PLUS more. That includes an area that Tom Stenzel, President of United Fresh, found disturbing in that the bill as the initial draft is written calls for EVERY step in the supply chain to be able to access a full pedigree of the product. There's a reason for that. Let's say a product goes from Grower (1) to Processor (2) to Shipping Facility (3) to a Consolidator (4) to a Distribution Center (5) to a Store/Restaurant (6). Now let's say that there is a problem brought to the attention of the FDA regarding the Consolidator (4). (Sorry, I don't mean to pick on consolidators). The Act as it is written means that the Consolidator would be able to access the entire flow for immediate traceability. That is not a problem with our system. To read the entire act the way it is drafted, just go to this link: http://energycommerce.house.gov/Press_111/20090526/fsea_draft.pdf

Here is a summary of the contents of this bill:


May 26, 2009
Summary of Discussion Draft of the Food Safety
Enhancement Act of 2009
Committee on Energy and Commerce
Food Safety
1. Creates an up-to-date registry of all food facilities serving American consumers: Requires all
facilities operating within the U.S. or importing food to the U.S. to register with the FDA annually.
2. Generates resources to support FDA oversight of food safety: Requires registered facilities to pay an annual registration fee of $1,000 in order to generate revenue for food safety activities at the FDA; requires registered facilities to pay for FDA’s costs associated with reinspections and food recalls; allows FDA to charge a fee to domestic firms requesting export certificates for exported food.
3. Prevents food safety problems before they occur: Requires all facilities operating within the U.S. or importing food to the U.S. to implement safety plans that identify and protect against food hazards. FDA would have the authority to specify minimum food safety plan requirements and to
audit food safety plans.
4. Requires safety plans for fresh produce: Directs FDA to issue regulations for ensuring the safe production and harvesting of fruits and vegetables.
5. Increases inspections of food facilities: Sets a minimum inspection frequency for all registered facilities. High-risk facilities would be inspected at least once every six to 18 months; low risk facilities would be inspected at least once every 18 months to three years; and warehouses that
store food would be inspected at least once every three to four years. Refusing, impeding, or delaying an inspection is prohibited.
6. Improves traceability of food: Enhances FDA’s ability to trace the origin of tainted food in the event of an outbreak of foodborne illness. FDA would be required to issue regulations that require food producers, anufacturers, processors, transporters, or holders to maintain the full pedigree of the origin and previous distribution history of the food and to link that history with the subsequent distribution history of the food; and to establish an interoperable record to ensure fast and efficient traceback (current law permits facilities to hold a record in any format — paper or electronic —
making efficient tracing of foods difficult for FDA). Prior to issuing such regulations, FDA would be required to conduct a feasibility study, public meetings, and a pilot project.
7. Enhances the safety of imported food: As an additional layer of protection, FDA can require food to be certified as meeting all U.S. food safety requirements by the government of the country from which the article originated or by certain qualified third parties. Third party certifying
entities must meet strict requirements to protect against conflicts of interest with the firm seeking certification.
8. Expands laboratory testing capacity: Requires FDA to establish a program to recognize laboratory accreditation bodies and to accept test results only from duly accredited laboratories. Gives FDA the ability to require laboratories to send test results to FDA.
9. Provides strong, flexible enforcement tools: Provides FDA new authority to issue mandatory recalls of tainted foods. Strengthens criminal penalties and establishes civil monetary penalties that FDA may impose on food facilities that fail to comply with safety requirements.
10. Creates fast-track import process for food meeting security standards: Permits FDA to develop voluntary security guidelines for imported foods. Importers meeting the guidelines would receive expedited processing.
11. Enhances the safety of infant formula: Enhances FDA’s ability to assure the safety of new infant formulas before they go on the market.
12. Advances the science of food safety: Directs the Secretary to include food in an active surveillance system to assess more accurately the frequency and sources of human illness. The Secretary is also directed to identify industry and regulatory approaches to minimize hazards in the
food supply.
13. Enhances FDA’s ability to block unsafe food from entering the food supply: Strengthens FDA’s authority to administratively detain unsafe food products. Grants FDA “quarantine” authority under which the agency may restrict or prohibit the movement of unsafe food products from a particular geographic area.
14. Directs FDA to assess the use of carbon monoxide in certain foods: Requires FDA to conduct a safety review of the use of carbon monoxide in meat, poultry, and seafood products.
15. Enhances transparency of GRAS program: Requires posting on FDA’s website of documentation submitted to FDA in support of a “generally recognized as safe” (GRAS) notification.
16. Requires country-of-origin labeling and disclosure: Requires all processed food labels to indicate the country in which final processing occurred. Requires food manufacturers to identify the country of origin for all ingredients on their websites. Requires country-of-origin labeling for
all produce.
General Provisions
1. Creates an up-to-date registry of importers: Requires all importers of drugs, devices, and foods to register with the FDA annually and to pay a registration fee.
2. Requires unique identification numbers for facilities and importers: To enhance information about FDA-regulated entities, creates unique identification numbers for all drug, device, and food facilities and importers.
3. Creates a dedicated foreign inspectorate: Requires FDA to establish and maintain a corps of inspectors to monitor foreign facilities producing food, drugs, devices, and cosmetics for American consumers.
4. Grants FDA new authority to subpoena records related to possible violations.
5. Provides protection for whistleblowers that bring attention to important safety information: Prohibits entities regulated by the FDA from discriminating against an employee in retaliation for
assisting in any investigation regarding any conduct which the employee reasonably believes constitutes a violation of federal law.

FDA CLARIFIES DIRECTION AND FOCUS

Dr. David Acheson, Associate Commissioner for Foods for the FDA made the following opening statement before the Subcommittee on Horticulture and Organic Agriculture, House Committee on Agriculture on May 14, 2009.

His remarks are very clear in stating the direction and focus of the FDA in moving forward under the direction of the O'Bama administration. If you wish to see this statement with additonal comments and notations by FoodTRACE, you can view the pdf file at www.usfoodtrace.com under "Government Related Articles".

The link to his opening statement is: http://www.fda.gov/ola/2009/foodsafety051409.html

Tomato/Pepper Event 2008 Review

Questions on the Cost of GS1 for Produce Industry

Probably one of the most asked questions we continue to receive is "What is the cost of implementing the GTIN into my company?" Not only is this an excellent question but one which, unfortunately due to the complexity fo the implementation process for the GS1 standard, is one where the answer is different for every company.

The costs associated with the implementation of the GS1 standards is a well kept secret. Not necessarily intentional however. There are 4 elements that need to be addressed and all of them have a cost associated with them.
1. Cost of the numbers themselves: This is dependent upon internal factors for each company, dollar volume and the amount of numbers needed primarily. One company told me they paid $18,000 for 18 numbers. I've heard ranges from $800 to $30,000+. The annual renewal fee, we've been told, is anywhere from $500 to several thousand dollars. Also, companies in our industry just do not keep the same products. Enhancements, changes, recipes, packs can all require changing or adding numbers which is not free.
2. Software modification: This gets little attention but can be extremely costly for some and minimal for others. The GTIN is 14 digits and companies that don't have the capacity for that number of digits can have considerable expense to accomodate that. One chain store of over 200 stores told us that that cost for software adaptation to be able to properly use the GTIN in their system was a 6 digit number for them, and the first number was not a 1! Most companies can adapt easier perhaps but there is software programming and modification costs that will occur.
3. Hardware: At least for the grower/shipper community, this is generally a new expense and others that may require it if they are not currently using the right scanners for companies that need to scan. You have to be able to scan the GTIN to get it into your system typically. What does a scanner cost? My guess is $500 to $1500. How many does a company need? That varies of course but if a company is using them in a warehouse full of product and forklifts, it could be quite a few and some will most likely be damaged each year so it is a continuing cost to some extent.
4. Personnel: You can't add all this without having that area managed and in MANY cases that will be an additional employee. This has been confirmed to us by more than one company is their estimation.

The PMA (Produce Marketing Association) stated in their submission to the FDA last year that the implementation of the GTIN would cost the industry "hundreds of millions" of dollars and take years to implement.

Finally, a comment. The FDA hired the IFT (Institute of Food Technologists) last September to do a study on traceability in the industry currently, what is available and how effective current practices are (thats's a summary, not a verbatim). They are required to submit a report to the FDA this September with their analysis of traceability AND their recommendations. We look forward to that report and subsequently getting some direction and understanding from the FDA as to what they are going to require. The amount of legislation on food safety, traceability, epidemiology and other areas is at a record level with at least 10 pieces of legislation written or being written. Whatever the final direction is going to be has not been determined yet. We shall see.

FDA using new guidelines detrimental to industry?

Spinach --- Tomatoes --- Peanuts --- Pistachios --- Spices --- what's next?
The FDA has a new attitude in responding to the events in the interest of public safety. It's pretty simple... Kill the herd, we'll find the infected one later. Please read these two articles.. http://www.nytimes.com/2009/04/07/health/policy/07food.html?_r=2&emc=eta1 and http://cnnwire.blogs.cnn.com/2009/03/31/take-pistachios-off-your-menu-fda-advises/ .
Very short summary.... on March 24, 2009, Kraft Foods notifies FDA that they have found salmonella in pistachios during their testing and traced it back to one company operation in California. ON March 31, 2009, FDA tells consumers to take ALL pistachios off the menu.

Is this type of reaction over-reacting? Yes and No. If this action saves one life then it is hard to disagree with the action taken by the FDA. However, is it fair to shut down an entire industry when the notification also included the traceback to the supplier? If the FDA controlled the auto industry and found brakes to be faulty on one brand, would it be fair to tell the consumers not to buy ANY car?

I sympathize with Dr. David Acheson. Although I cannot agree with every move made by the FDA, my respect for this man is unwaverable. He has done more than any individual, in my opinion, to create and expand the awareness and the criticalness of the food safety issues that we face. This will eventually lead to more correct answers, more viable solutions and more solid food safety programs.

The new O'Bama administration, putting new faces and names at the top of the FDA, is already making changes, establishing their priorities and implementing short term solutions to protect the public.... even though it is at a potentially great expense to the industry.

Last week some of my group was in DC and we met with both political and industry groups. You cannot pick up a major paper it seems these days without finding an article on food safety, epidemiology, traceability, consumer protection on food and other areas. It is a hot item, a public item, an item both republicans and democrats can get behind and they are doing it.

The articles above indicate the importance of what we at http://www.usfoodtrace/ are doing. We address both traceability and epidemiology as well as a centralized data base. This combination is critical in determination of ground zero of an event when it does occur. Determining ground zero as quickly as possible is imperative in helping the industry avert losses when problems do occur.

Consider this based on two articles.... if you were a company spending hundreds of thousands of dollars per year on food safety to insure that your product was indeed safe, but another company of any size does not follow or ignores this area and has a problem that becomes known to the FDA....both companies are treated equally now based on the FDA response on pistachios. Not only those two companies, but any others producing the same product now have a greater potential to get shut down.

It reminds me of the tomato issue last year.... if one tomato is bad, shut the industry down until we find out!!! BUT...oh wait.... it wasn't tomatoes after all.... too bad.