Food Safety Bill Update

UPDATE on H.R. 2749, July 27, 2009


WASHINGTON - Today, Ranking Member Frank Lucas sent a letter to his colleagues in the U.S. House of Representatives urging them to not rush the Dingell-Waxman bill, H.R. 2749, through Congress. The bill is scheduled to be considered by the full House as early as tomorrow under suspension of the rules. This means that debate on this bill will be limited to twenty minutes, and there will be no opportunity to offer amendments.

"Our nation has the safest food supply in the world. Even so, we must continually examine our food production and regulatory system, and move forward with changes that improve food safety. But to do so without thoughtful and careful deliberation is simply irresponsible. H.R. 2749 is the result of a flawed and incomplete process. It will lead to huge regulatory burdens on our nation's farmers and ranchers, and it contains very little that will actually contribute to the goal of safer food.

"During a recent Committee hearing on the general topic of food safety, not a single producer witness would support this bill in its current form. Now Members of the House are being asked to vote on this bill without consideration, debate, or the opportunity to improve it. Worst yet, we haven't even seen the bill and we can't even obtain a copy of it.”

"For these reasons, I urge my colleagues to vote against rushing H.R. 2749 through Congress. I urge my colleagues to vote against H.R.
2749. Our nation's farmers, ranchers, packers, processors, retailers, and consumers deserve better," said Ranking Member Frank Lucas.


We at FoodTRACE urge caution and restraint as well in determining what your next steps regarding food safety, traceability and other cost areas that need to be addressed. Keep these FACTS in mind before committing dollars to the PTI initiative or any other programs that are being discussed.

1. Secretary of Health and Human Services stated on July 7, 2009 – “In the next 3 months, the Food and Drug Administration will issue draft guidance on steps the food industry can take to create tracing systems that will allow us to more quickly detect the sources of contamination and more quickly remove the unsafe food from store shelves. To hear her directly, go to http://usfoodtrace.blogspot.com/ and scroll down to the July 8 posting and watch a 1 minute 42 second clip where her statement as well as statements regarding food safety and traceability are also made by Secretary of Agriculture Tom Vilsack and Vice President Joe Biden.
2. IFT Report Due in September to the FDA. The FDA authorized IFT (Institute of Food Technologists) last September to analyze the various forms of traceability systems currently being used or in development. FoodTRACE® was one of those systems. The IFT was given one year to examine those systems and make their recommendations to the FDA this coming September. This ties in very well with the above comment made by Secretary Sebelius. The produce industry should NOT be jumping into anything, especially as costly as the PTI before understanding what the needs, requirements or at least guidance as stated is made.
3. FoodTRACE has not requested of any company to this point to sign on for our system although we are capable of accepting data and providing reporting options at this time. We firmly believe and continue to be proven by statements and actions in the industry and politically, that we are the best approach regarding traceability, and we go much further than the PTI regarding traceability at a fraction of the cost of overall implementation of the PTI option.

FoodTRACE - How it works

The following video will provide you with an understanding of how the FoodTRACE program works. In addition to the traceability features, reporting, notifications, compliance information, recall assistance and much much more is provided by FoodTRACE all at one low monthly price. No hidden costs, just a data analysis fee to get the proper fields of data determined and a low monthly fee is it. No numbers to buy which can be thousands of dollars, no software modifications to your current systems, no software to buy, no hardware or scanners to purchase, no additional labor required for managing and implementing additional systems, no syncronization fees or any other hidden or ancillary costs -- you want transparency --- here you get it. See how the program works here:

Additionally, FoodTRACE is very clear on what it costs. See the schedule below and you can see for yourself, that literally any company in the United State OR abroad can participate in this program. We GUARANTEE that we meet all current requirements of the U.S. Government regarding traceability. Based on the current laws being discussed as of this posting, FoodTRACE also EXCEEDS every nuance of every law that is being discussed that includes any parameters regarding traceability. FoodTRACE is here, it is now - Welcome to the end of traceability confusion.

FoodTRACE does MORE for LESS!

Take the Government's Word For What's Going On

These videos speak for themselves.... The first one is "snippets" of portions of the speeches on July 7th regarding traceability and tracking. The link below the video will take you to the entire 21 1/2 minute announcement by Secretary Sebelius, Secretary Vilsack and Vice President Joe Biden

To see the full announcement click here ---> http://www.whitehouse.gov/blog/Blogging-to-the-Middle-Improving-Food-Safety

FoodTRACE exceeds current Government Direction

FoodTRACE™ meets EVERY suggested requirement of the comments made today in Washington D.C.

IMPORTANT information announced today by, from left to right above, Vice President Joe Biden, Secretary of Health and Human Services Kathleen Sebelium and the Secretary of the Department of Agriculture Tom Vilsack.

On July 1, 2009, the Working Group submitted its general principles to the President. The Working Group identified three core food safety principles to guide the development of a modern, coordinated food safety system.

• Principle 1: Preventing harm to consumers is our first priority: Too often in the past, the food safety system has focused on reacting to problems rather than preventing harm in the first place. The Working Group recommends that food regulators shift towards prioritizing prevention and move aggressively to implement sensible measures designed to prevent problems before they occur. Key to this approach is setting rigorous standards for food safety and providing regulatory agencies the tools necessary to ensure that the food industry meets these standards.

• Principle 2: Effective food safety inspections and enforcement depend upon good data and analysis. High-quality information will help leading agencies know which foods are at risk; which solutions should be put into place; and who should be responsible. The Working Group recommends that the Federal government prioritize crucial inspection and enforcement activity across the world; support safety efforts by States, localities and businesses at home; and utilize data to guide these efforts and evaluate their outcomes.

• Principle 3: Outbreaks of foodborne illness should be identified quickly and stopped. The Working Group recommends the establishment of a food tracing system that shortens the time between outbreak detection, resolution, and recovery. It is in everyone’s interest for outbreaks to be rare in number, limited in scale, and short in duration.

NOTE: FoodTRACE is the ONLY system available for traceability today that combines traceability with epidemiology. As we have continually stated, part of our program includes working with illness data to assist in shortening the time of the overall impact of an outbreak.

An additional statement made today in this announcement was:

Developing Industry Product Tracing Systems: Within three months, FDA will issue draft guidance on steps the food industry can take to establish product tracing systems to improve our national capacity for detecting the origins of foodborne illness.


Also today in a press release by the PMA’s President, Bryan Silberman stated the following as a part of his comments:

“Similarly, the traceback announcement appears consistent with our efforts on the Produce Traceability Initiative, though we will need to review the details as they emerge. The recognition of the clashing jurisdictions and the resulting disruptions to agencies charged with food safety is an important step toward creating a more rational and workable regulatory system.”

NOTE: The PMA cannot state as a fact that the GS standard or PTI as proposed, will, as a certainty, meet government guidelines.

FoodTRACE™ continues to be the only program being offered that has, and still, meets every nuance and area that has been or currently is in discussion regarding the requirements of the government regarding traceability. FoodTRACE™ offers a much more in depth program and at a fraction of the cost of the PTI.

We have been and will continue to follow the developments at government levels, but at FoodTRACE™, compliance with government guidelines, we have exceeded every area that has been discussed and continue to be affordable to all size companies.

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.