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“Economically Motivated AdulterationFDA Public Meeting”

May 1, 2009

Craig W. Henry Ph.D.Senior Vice President and Chief Operating Officer, Scientific

and Regulatory AffairsGrocery Manufacturers Association

Washington, D.C.chenry@gmaonline.org

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GMA Approach to Economic Adulteration

• The GMA Science and Education Foundation has formed a Economic Adulteration working group composed of GMA industry members.

• The WG has taken some strategic actions e.g. • Current review of adulteration in a number of

industries focused on detection and deterrence,• Development of a white paper to address those

products most susceptible to adulteration and characterization of industry best practices.

• Plan to hold national meeting on counterfeiting and economic adulteration early in 2010 that will embrace multiple industries and especially food and consumer packaged goods.

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GMA Response to FDA Q&As

• 1a - What information should U.S. regulators seek and from what sources to help predict and prevent EMA? What further steps can U.S. regulators take to predict and prevent EMA?

• Seek and widely disseminate intelligence and other info from foreign governments.

• Consider less developed countries lacking infrastructure/means to broadcast information.

• FDA’s PREDICT database should be given a high priority to screen imported foods.

• When implemented, FDA should increase the value of this information by holding ‘’secure scoping” meetings with key stakeholders when intelligence information indicates the potential for product contamination of a particular supply chain.

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GMA Response to FDA Q&As• 1b - What are members of industry doing to prevent

EMA? What further steps can industry take to prevent EMA?

• The food industry has actively addressed economic adulteration of fruit juices for over 20 years.

• This program consists, in part, of companies collaborating on analytical methods to detect adulteration.

• The program started with basic juices like orange, apple, and grape and has now expanded to include more “specialty” fruit juices like Acai.

• One of the major lessons learned from this program is that responsible companies must continually adjust and upgrade their monitoring programs.

• Just as unscrupulous operators are continuously adjusting their practices to evade detection, responsible companies are continuing to refine their methods and to share intelligence in order to stay ahead.

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GMA Response to FDA Q&As• 1c - What recent examples of known or suspected

EMA domestically and internationally should U.S. regulators study and learn from?

• Aside from melamine, the use of illegal food colors methyl yellow, orange II, malachite green and, a few years ago, Sudan Red use in chili peppers.

• Regulators should study how the industry responds and adjusts to threats of EMA in fruit juices as a model.

• The takeaway lesson is that EMA is an unethical activity that generally operates at the fringes of the industry.

• Often EMA operates by fractional substitution of cheaper materials for the authentic food.

• Significant substitution that leads to adverse health consequences is fairly rare.

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GMA Response to FDA Q&As• 1d - What information do other organizations

(including, but not limited to, trade organizations and security service providers) have that would be useful in predicting and preventing EMA? What are members of other organizations doing to prevent EMA?

• Food Chemicals Codex has established an Ingredient Adulterant Advisory Panel with the goal of revising and updating the analytical methods upon which some ingredient specifications are based.

• This should make it more difficult to evade detection when ingredients are substituted.

• There are a few isolated centers of expertise, e.g., the Center for Food Protection and Defense at UMN, and the Anti-Counterfeit and Product Protection Initiative at MSU.

• The US gov’t could create a center of expertise specifically focused on economic adulteration.

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GMA Response to FDA Q&As• 1e - What are other government regulators within

and outside of the United States doing to predict and address EMA?

• UK Food Safety Agency (possibly other EC states) has an active surveillance programs.

• US regulators could hold an invite-only meeting w/ some of their EU foreign regulatory counterparts, including some select US and EU industry members, to discuss detection approaches related to economic adulteration.

• “Strategic Partnership Program Agroterroism (SPPA)” – like closed door meetings involving the government and industry• Conduct in-depth vulnerability analyses of certain

products/supply chains that have been identified as likely targets.

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GMA Response to FDA Q&As

• 1f - What indicators (economic-based, chemistry-based, etc.) might be used to detect potential EMA?

• High-value, easy to disguise, narrow point of product identity control [ie, ‘nitrogen analysis’], homogenous product [liquids in particular], bulk product that is hard to see due to packaging/transport, etc.

• High value ingredient (e.g., olive oil, fruit juice, honey), with the availability of “cheaper” materials (other oils, juices or sugar), with standards that make the detection of substitution very difficult.

• Ingredient shortage provides financial incentive for EMA. 

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GMA Response to FDA Q&As

• 1f - What indicators (economic-based, chemistry-based, etc.) might be used to detect potential EMA? (cont’d)

• There may also be value in the monitoring of commodity prices both domestically and globally. • A presentation was made at the Risk Analysis:

the Science and the Art meeting held in December 2008 in Boston on such an approach.

• The intent is to detect sudden, unexpected and abrupt changes that may be suspicious of fraudulent activity using quantitative risk indicators to detect fraud in trade against the budget of the European Community.

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GMA Response to FDA Q&As• 2 - Questions pertaining to attributes of products,

components/ingredients that may be at risk for EMA: • a. What are attributes of products or

components/ingredients of products that may cause them to be more vulnerable to EMA?

• b. What food products are marketed based on measured content of certain constituents, such as content of certain proteins, certain fats, or certain sugars?

• There are thousands of food products and ingredients. Many of the more basic commodity type of products and ingredients still have specs based upon simple measurements of protein, fat or sugar.

• The more sophisticated food companies complement the simple tests with more advanced analytical methods.

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GMA Response to FDA Q&As• 3 - What changes relevant to the risk for EMA have

occurred? • EMA is not new and the vulnerability of food to EMA

may not be increasing. • Responding to EMA was one of the driving forces

behind the formation of the FDA in the early 1900s. • Globalization of food increases the likelihood of

EMA.• Trade in foods is not limited to raw commodities.• It includes thousands of manufactured ingredients.• An EMA event is likely to extend to secondary, and

tertiary users of ingredients (e.g., the problems caused by the adulteration of paprika with Sudan Red).

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GMA Response to FDA Q&As

• 4 - Questions about detection methods: • a. What analytical equipment or methods

currently used by industry and regulators to establish the identity or quality of a product or its conformity to specifications may be inadequate to detect evidence of EMA or adulterated products or ingredients?

• GC, HPLC and other similar equipment that have “narrow” windows of detection and hence are prone to “false negatives”.

• They are also susceptible to “false positives” due to confounders.

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GMA Response to FDA Q&As• 4 - Questions about detection methods:

• b. Are there appropriate analytical methods/equipment that could be used instead of, or in addition to, existing methods or equipment in particular situations?

• Chromatographic, spectroscopic methods like NMR and high resolution mass spec. have been applied to detecting EMA.

• The choice of analytical method is determined by knowledge of the potential adulterant.

• NIR testing offers a potential to develop a spectral catalog of commodity products.

• Incoming shipments could be sampled and tested against a standardized spectra for that commodity to ensure integrity.

• Lack of conformance against the standard would result in the rejection of the shipment.

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GMA Response to FDA Q&As

• 4 - Questions about detection methods: • c. What rapid methods can be used to detect

adulteration of products or ingredients? • NIR is fast but there are currently no rapid methods

that can be universally applied.

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GMA Response to FDA Q&As

• 5 - What systems are currently being used to track and verify components/ingredients from their source?

• Many food companies already have traceability systems in place for their ingredients.

• Knowing, trusting, and verifying your supplier and expecting the same of their suppliers is critical.

• A key component is the verification of ingredients which should be done through a regular testing program.

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GMA Response to FDA Q&As

• 6 - Are there particular types of industry structures or supply chains that are especially vulnerable to, or secure from, potential EMA?

• Vertically-integrated, isolated and dedicated supply chain from origination to consumer can offer lower risk. • Vertical integration is not applicable or easily achieved for

all sectors.

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Summary

• Trust but verify throughout the supply chain.

• Broad product characterization using real-time methods will help minimize ECM.

• Early warning through tools like major fluctuations in commodity prices for products of concern may help.