Getting IP in place: Tips to satisfy regulations & market demand

by Emily Buckley
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Identity Preservation (IP) and the need for it have become headline and front page news this year. For instance, take the following events:

• the United States Homeland Security department enacted registration and ‘traceback’ requirements for food and feed;

• the European Union enacted and has begun to enforce stringent new regulations on traceability of food and feed containing genetically modified organisms (GMOs), with general traceability to go into effect in January 2005;

• a recent BSE case (also known as mad cow) in the state of Washington, U.S., prompted renewed calls for traceability of meat and poultry products.

All of these recent developments and many others underscore the need for cost-effective traceability systems that grain producers, processors and exporters can implement to meet new marketplace and regulatory demands for food safety and identity preservation.

Traceability is the end result of an effective Identity Preservation (IP) program. If you have an effective IP program, you will have traceability for your product. This applies whether you are satisfying the new E.U. regulations on labeling and traceability of GMOs in food and animal feed, or the European Union’s 2005 deadline for traceability of all food offered for sale in the E.U.

The new E.U. regulations on GMOs in food and feed provide an instructive example of what food and feed producers, handlers, processors, distributors and exporters can expect in the months and years ahead. (See sidebar below.)

Deadlines for enforcement of these new regulations are fast approaching. Fortunately, however, there are good models available for designing and implementing an IP program to satisfy all of the E.U.’s requirements. Enforcement of these new regulations will start in April 2004, and general traceability enforcement will begin in January 2005. U.S. Homeland Security requirements under the 2002 Bioterrorism Act, while not as rigorous as the E.U.’s, nonetheless require some basic elements of Identity Preservation as well.



Complying with the new E.U. GMO regulations — and with similar regulatory or buyer requirements regarding GMOs in other markets — requires a well-documented traceability system that demonstrates reasonable precaution and due diligence to keep GM material out of the product. For GMO labeling and traceability, a product sampling and quantitative GMO testing program is needed to verify that a product’s GMO levels are below the E.U.’s specified thresholds (0.9% or 0.5%).

In the case of general traceability for food, solid documentation will be the key. Some testing may also be in order for trait preservation or other indicators that prove "it is what you say it is."

The E.U.’s new traceability rules, beginning in January 2005, stipulate that food importers will need to document the chain of custody for ingredients in their products from raw materials through primary processing and on through to the product being delivered to the E.U. buyer’s port of entry.

The U.S. currently does not require traceability. However, Homeland Security and related issues are quickly driving establishment of such regulations. From discussions in progress, it appears that the initial programs will probably require that food and feed manufacturers, processors, growers, handlers, storage and distribution operations, transporters and importers will need to keep records of the immediate previous source of the food, feed or ingredient being accepted, the transporter who delivered it, the next recipient of the firm’s product and the transporter delivering it to that recipient.



IP systems will differ from one food producer to the next. Every producer uses different ingredients, raw material sources, production facilities and storage and transportation systems. And the target requirements will differ, depending upon whether the producer’s goal is to meet GMO regulations, general traceability requirements or Homeland Security mandates. All of these elements play a part in the design of an effective IP program.

Comprehensive IP programs have the following common elements:

• Product(s) and inputs are segregated from other products to ensure that specific lots or product types maintain their integrity.

• Separate production lines are maintained when possible. Where they are not possible, procedures are put in place to flush the production system before producing a new run of IP product.

• All process inputs are traceable back to their source, with a traceable chain of custody as the products move through the food production chain.

• Qualified production personnel run the IP program. These personnel know how to operate an IP system; they understand basic traceability principles and they know how their individual tasks fit into the whole production and IP system.

• Quality Assurance staff craft and monitor an assurance program to verify that the IP program is working properly. This includes inspection and monitoring of processes, and sampling and testing on a risk-assessed basis.

• The design and operation of the IP system are thoroughly documented. This includes information technology systems that allow for efficient storage of, and ready access to, traceability information. The documentation includes records of segregation procedures, clean-down procedures, transaction certificates of compliance that verify the chain of custody, training records, and monitoring and testing records. Any IP claims made by input and ingredient providers are documented, with the evidence (test certificates, transaction certificates of compliance, etc.) required to support those claims.



It is no small matter to design and implement an IP system that includes all of the above elements. The end result must be an IP program that complies with the regulations and/or market specifications in the areas where the producer or the producer’s clients do business. Many food producers find that outsourcing is the most practical, cost-effective approach to designing, developing and even implementing their IP system. This approach saves on personnel costs. In addition, accessing an organization that is expert in the new regulations assures that all bases are covered.



Once the IP system is in place and operating smoothly, many companies bring in an independent third party certifier to confirm that the company’s IP system is, in fact, delivering products to the system’s specifications. Third-party certification offers an additional level of risk reduction and added protection in case of a challenge to a product’s non-GMO, specific trait or other differentiating claim.

Scientifically validated, third-party verified IP programs have given many food and agricultural producers access to new markets. For example, producers who have put a non-GMO IP program in place, making the details of their program readily available to clients who wish to see verification of the company’s non-GMO claims, have found their products welcomed in the E.U. market. The ‘market advantage’ of a comprehensive, certified IP program gives a food producer a competitive edge and helps them maintain and expand their markets and market share.


Key components of new E.U. GM food and feed regulations


The regulations mandate product traceability through documentation and implementation of Identify Preservation Systems and Procedures for the entire supply chain.


Products containing GMOs must be labeled as such, even when the GM level is undetectable by test. Products containing traces of GMOs below the appropriate regulatory tolerance thresholds are exempt from labeling, provided that compliant traceability systems are in place and traces of GMO are adventitious and technically unavoidable.


The regulatory tolerance for E.U. authorized GMOs is 0.9% and 0.5% for unauthorized GMOs that have already received a favorable E.U. risk assessment. Compliant traceability systems must be in place and must demonstrate that any traces of GMO are adventitious and are technically unavoidable.

For more regulation information, visit


John Fagan, Ph.D., founded and serves as chief scientific officer of Genetic ID N.A., Inc., which tests for specific traits and GMOs in agricultural products. Dr. Fagan is also a Director for Cert ID, which develops, implements and monitors IP certification programs for food and agricultural producers in North America, South America, Europe, and Asia. He can be contacted at