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.