May 2008 Issue

Too Much Information? New Labeling Regulations for 2008
By Cynthia Kupper, RD, CD
Today’s Dietitian
Vol. 10 No. 5 P. 8

Suggested CDR Learning Codes: 4030, 5110, 7100, 7120; Level 1

Food labeling regulations continue to multiply, and we can anticipate two major additions this fall when the USDA country of origin labeling (COOL) law will be fully implemented and the gluten-free labeling law, mandated under the Food Allergen Labeling and Consumer Protection Act (FALCPA), takes effect. While these regulatory changes are designed to provide consumers with better information, enabling them to make informed buying decisions, their sheer complexity and use of unfamiliar terminology can confuse the average food purchaser.

Dietitians are uniquely positioned to explain what the new information means and why it has been included on packages. But first, they need to fully understand the new regulations.

Country of Origin Labeling
Recent news stories of bovine spongiform encephalopathy (mad cow disease), “downer” cows being slaughtered for human consumption, and Escherichia coli contamination of hamburger meat and produce have led Americans to be more concerned about the safety of the food supply. Although the United States has had comprehensive regulation and inspection protocols in place for decades, globalization and free trade mean that more food comes from sources outside U.S. government jurisdiction.

In 2002, Congress passed the Farm Security and Rural Investment Act (Public Law 109-97), which created mandatory COOL for products under USDA jurisdiction. The law was intended to provide consumers with information needed to make informed decisions about their purchases related to the product’s origin and to promote U.S. food products, which in most cases are assumed to be better regulated. The law required that “a retailer of a product covered under this ruling inform consumers of the country of origin” beginning September 30, 2004. Initially, the guidelines were voluntary, but COOL became mandatory for wild and farm-raised fish and shellfish on September 30, 2006. After at least two delays in implementation, other retailers must now comply by September 30, 2008.1

The commodities covered by this law include beef, lamb, and pork (muscle cuts and ground); fish and shellfish (farm raised and wild); perishable agricultural commodities (fresh and frozen fruits and vegetables); and peanuts. The retailer is responsible for providing this information to the consumer rather than the producer, who may be in another country. The law exempts the following:

• foodservice establishments such as restaurants (even those within a retail business, such as a deli within a grocery store), cafeterias, and food stands;

• companies with less than $230,000 in annual sales of the specified commodity;

• exporters; and

• butcher shops and fish markets.

Similarly, certain classes of commodities are exempt, including foods that are processed (where the processing results in a “change in the character” of the commodity) and foods that have been combined with at least one other covered commodity or other substantive food component.

Processing that results in a change in character includes cooking, curing, smoking, and restructuring (eg, emulsifying and extruding, compressing into blocks, and cutting into portions). Examples of excluded commodity items include fish sticks, surimi, mussels in tomato sauce, seafood medley, coconut shrimp, soups, stews, chowders, sauces, pâtés, smoked salmon, marinated fish fillets, canned tuna, canned sardines, canned salmon, crab salad, shrimp cocktail, gefilte fish, sushi, and breaded shrimp. Also excluded are poultry and poultry products.2 COOL does not apply to ingredients in cereals, soups, or any other foods processed in the United States, no matter where they originate.

The country of origin information can be provided by use of a label, stamp, mark, placard, or other clear and visible sign either on the commodity, the package, the display, or the holding unit or bin containing the product at the point of consumer sale. Fish must also indicate whether it is farmed or wild. The only requirement for positioning of the label is that the COOL must appear separately from the product’s name or ingredients list.

COOL has the following three distinct categories:

• “U.S. only origin”: primarily for animals that are born, raised, and processed or slaughtered exclusively in the United States (Products of Hawaii and Alaska can carry this designation only if they spend less than 60 days in transit through Canada to the mainland.);

• “Foreign only origin”: for those products, primarily animals, that are produced and processed entirely outside the United States; and

• “Mixed origin”: a commodity must be labeled of mixed origin according to the country of birth, raising, and slaughter.

This last category can cause confusion. A mixed origin label would read as follows:
“Born in Country X, Raised in Country Y, and Slaughtered in the U.S.” This labeling requirement also applies to mixed or blended products, such as ground beef, if it comes from different countries of birth, raising, or slaughter. A product that is blended or comingled, such as a bag of mixed frozen fruits in which the fruits were imported from a number of countries and processed in the United States, must be labeled “from [all countries], processed in the United States,” with each country listed alphabetically. Too much information to be useful?

COOL Audit Trails
Retailers and suppliers are required to maintain detailed records of the source(s) of the commodities they sell. The law requires suppliers and retailers to maintain records to establish and identify the immediate previous source and immediate subsequent recipient of a commodity for one year from the date of the transaction. The record must be unique to the individual product (eg, an individual item purchased by a consumer). The USDA requires retailers at the point of sale to be able to show documentation of a product’s country or countries of origin and the method(s) of production (eg, farm-raised or wild fish). The U.S. Secretary of Agriculture can require that any person who prepares, stores, handles, or distributes a commodity for retail sale also maintain a verifiable record-keeping audit trail. When it concerns animal products, this includes records of birth, where an animal was raised, death, and the processing of each animal.3

While it may seem comprehensive, COOL is not required for FDA-regulated commodities—essentially anything but animal products. However, some companies are voluntarily including COOL-like information on labels but not always following the intent of the USDA guidelines.

Both USDA- and FDA-imported products are already required to label the country of origin to inform the “ultimate purchaser,” the last U.S. person who will receive the article in the form in which it was imported. Under that guideline, processed foods could be labeled in a somewhat deceptive manner—for example, olive oil labeled as a “Product of Italy” but made from olives grown in Greece, processed in Algeria, stored in Spain, and bottled in Italy. As a rule of thumb, imported canned fruits and vegetables labeled as “Product of ______” are merely packed, not necessarily grown and processed, in the specified country. Packing is important, of course, but most consumers are more concerned with where a fruit or vegetable is grown, which may tell them what kinds of fertilizer, pesticide, or additives it contains.

Needless to say, implementing COOL is costly, time consuming, and could require updated tracking systems. Imagine the complexity of tracking an individual hog, not only “from farrow to finish” on a farm but also through slaughter, processing, packing, transport, packaging, storing, wholesaling, and retailing of more than a dozen different pork products.

The Agricultural Marketing Service has estimated that it would cost producers, food handlers, and retailers nearly $2 billion in the first year to comply with new record-keeping requirements for certain products sold at retail and labeled by their country of origin. The estimated compliance costs were broken down as follows: $1 billion for farmers and ranchers; $340 million for about 100,000 food handlers, including packers, processors, importers, wholesalers, and distributors; and $627 million for retailers.

Although retailers are ultimately held accountable by the USDA for compliance, the Food Marketing Institute is advising retailers to pass some or all of the cost and liability of implementation and responsibility to their suppliers. Companies such as Hormel Foods and Wal-Mart have been discussing new policies and procedures for compliance with their suppliers. Some companies are also discussing passing any fines back to their suppliers—the farmers. This shift could create a lower profit margin for farmers—or, more likely, higher prices all along the supply chain.

As COOL goes into effect, key players in the food industry are now advocating for a system that is just as effective but less costly to comply with. In the short term, however, we will see more information on our supermarket shelves.

Gluten-Free Labeling
The regulation of gluten-free labeling has been a hot topic of discussion for several years. Both consumers and the food industry are awaiting formal regulations from the FDA, which are expected this fall.

At about the same time, the World Health Organization’s Codex Alimentarius Commission should adopt the “Draft Revised Standard for Foods for Special Dietary Use for Persons Intolerant to Gluten” (formerly known as the “Draft Revised Codex Standard for Gluten-Free Foods”). In November 2007, the Codex Alimentarius Commission established a revised definition for gluten-free foods and requested comments from government and international organizations before April 1, 2008. In July 2008, it is expected to adopt the definition as the standard.

In 1981, the first Codex standard for gluten free was published. Since 1998, the Codex Alimentarius Commission has been reviewing and revising the definition standards for gluten free. In the most recent revisions, the definition has been modified to state that products could be made from naturally gluten-free ingredients (no wheat, rye, barley, oats, or hybrids) and could contain no more than 20 parts per million gluten or could be made from gluten-containing grains that had been rendered gluten free and contain no more than 200 parts per million. Wheat starch is an example of an ingredient rendered gluten free. The current definition reduces the previously accepted parts per million for products rendered gluten free from 200 to 100.

On January 1, 2006, FALCPA, passed and signed in 2004, became law. FALCPA includes two particularly important sections. The first mandates the labeling of the top eight allergenic foods—milk, eggs, fish (eg, bass, flounder, cod), crustacean shellfish (eg, crab, lobster, shrimp), tree nuts (eg, almonds, pecans, walnuts), wheat, peanuts, and soybeans—by their common or usual name on all foods regulated by the FDA. Of notable exception is any highly refined oil derived from a food specified as an allergen and any ingredient derived from such highly refined oil. FALCPA’s requirements apply to all packaged foods sold in the United States that are regulated under the federal Food, Drug, and Cosmetic Act, including both domestically manufactured and imported foods. FALCPA, through the FDA, regulates all foods except meat, fish, poultry, and egg products and does not extend to drugs.

The second part of FALCPA requires the FDA to issue a proposed rule to define and permit use of the term gluten free on labels. This rule is to be made public no later than two years after the date of FALCPA’s enactment. No later than four years after the date of enactment, the FDA shall issue a final rule to define and permit use of the term gluten free on food labels. Such labeling will be voluntary and does not include products regulated by the USDA. Thus, 2008 is a watershed year for gluten-free labeling.

Table 1 offers a comparison of Codex and the proposed FDA regulation. It is important to note that both definitions are based on celiac disease research.

Table 1

— Sources: Codex Alimentarius Commission. Report of the 29th session of the Codex committee on nutrition and foods for special dietary uses. November 16, 2007. Available at: http://www.codexalimentarius.net/download/report/687/al08_26e.pdf; Food and Drug Administration. Food labeling: Gluten-free labeling of foods. January 23, 2007. Available at: http://www.cfsan.fda.gov/~lrd/fr070123.html

Gluten-Free Certification
While manufacturers need to comply with FALCPA and the standards set by the FDA for labeling foods gluten free, other certification programs that have grown in the absence of clear legal standards are also available. Two organizations in the United States now offer gluten-free certification for products. The Gluten-Free Certification Organization, a program of the Gluten Intolerance Group of North America, and the Celiac Sprue Association offer “Seal of Recognition” programs. These programs are not regulated by any government agency; rather, they are voluntary and set a stricter standard for use of their marks on gluten-free products. Each agency sets the standards of the program, and food manufacturers must meet these requirements to use the symbol on their package. Table 2 summarizes the two programs.

Table 2

Too Much Information?
A 2007 survey of more than 5,000 consumers of gluten-free products showed that 96% of consumers are brand loyal, seeking those they trust. While certification is a new concept for gluten-free products, approximately 64% of consumers surveyed were already looking for certification marks on packaging to indicate a higher standard for gluten-free products. Consumers make buying decisions based on the information on labels and want to see products labeled gluten free. They are unsure whether they should trust products with voluntary labeling statements such as “Produced in a plant with…”

These new labeling requirements have the potential to provide valuable information to consumers so they can make smart buying decisions. However, they may also cause confusion, which may require consumer education. The following are some potentially confusing areas:

• COOL may not provide the information a customer is seeking. In a recent discussion with a raw materials and finished product quality control manager, I was asked, “Do consumers really want to know the country of origin or the origin of the source ingredient? They most likely are not the same.”

For example, a U.S. company imports oats for the gluten-free market. The oats are repackaged or used in processed foods (eg, granola), and the label contains two labeling statements: “Gluten free” and “Product of the U.S.” This labeling sends up a red flag for the gluten-free–seeking consumer because, immediately, the oats are in question. Where did they originate? If they are not from one of the companies known to have uncontaminated gluten-free oats, should the consumer trust them? In this situation, the label provides only part of the information consumers want and need to have confidence in the product.

Keep in mind that COOL is not required for this product. But if one follows the COOL guidelines, repackaged oats should be labeled “Product of _____ country, processed in the U.S.” or simply “Product of ______.” The granola should identify the source of oats, such as “Oats (product of Canada)…”

Customers may need more specific information about the country or state of source of an ingredient if this is an issue for them.

• Foods labeled as gluten free may also contain allergen statements listing wheat. We are already seeing labels that have an allergen statement listing wheat, and yet the products are marked gluten free. This could be very confusing for consumers. Educating them is important, as is fully explaining and assuring them of the safety of the gluten-free definition of 20 parts per million.

In the near future, we may see changes in voluntary disclaimers, such as “may contain” and “processed in” statements. The use of these statements appears to be skewed, causing consumer confusion. It is important that dietitians have a unified way to deal with such statements. Today, experts in celiac disease and the gluten-free diet do not present a unified message to consumers about these statements. This adds to the confusion consumers have about their value. While changing labeling regulations are good and should assist the consumer, they also require a component of education about the changes and how best to use the information.

— Cynthia Kupper, RD, CD, is the executive director of the Gluten Intolerance Group of North America.

References
1. Agricultural Marketing Service at the U.S. Department of Agriculture. Country of origin labeling. Available at: http://www.ams.usda.gov/cool

2. Library of Parliament. Country-of-origin labelling (PRB 03-02E). Available at: http://www.parl.gc.ca/information/library/PRBpubs/prb0302-e.htm

3. Kansas State University Research & Extension. Country of origin labeling — COOL. Available at: http://www.oznet.ksu.edu/ansi/cool

Learning Objectives
After completing this module, the student will be able to:

1. Explain the reasons for and details of new country of origin labeling (COOL) regulations.

2. List four kinds of establishments that are exempt from COOL regulations.

3. Discuss what commodities are exempt from COOL requirements.

4. Discuss the problems of implementing COOL regulations for processed food products and those with components from different countries.

5. Briefly explain the history of gluten-free product labeling and explain how that will culminate in effective regulation in 2008.

6. Identify and discuss two areas of likely consumer confusion over new labeling regulations.

Examination
1. Country of origin labeling (COOL) will be required for the following products in September 2008:
a. Chicken, beef, pork, and fish
b. Wild and farm-raised fish and shellfish
c. Peanuts, tree nuts, and fruits and vegetables
d. Wild and farm-raised fish and shellfish; beef, lamb, and pork; fruits and vegetables; and peanuts

2. The Food Allergen Labeling and Consumer Protection Act (FALCPA) and gluten-free labeling of products cover which of the following products?
a. Milk products, cheeses, eggs, and lunch meat
b. Cereals, breads, baked goods, and pasta
c. Wheat, eggs, milk, soy, shellfish, fish, nuts, and peanuts
d. Medications, nutritional supplements, and vitamins

3. Codex defines gluten free as:
a. 20 parts per million.
b. ingredients without wheat, rye, barley, or oats and less than 20 parts per million gluten.
c. ingredients rendered gluten free that are less than 20 parts per million.
d. None of the above

4. The FDA-proposed gluten-free definition includes:
a. no wheat, rye, barley, or their hybrids and under 20 parts per million gluten.
b. oats that are under 20 parts per million may be labeled gluten free.
c. ingredients may be from wheat, rye, or barley that have been rendered to contain less than 20 parts per million gluten.
d. All of the above

5. Gluten-free certification programs are regulated by:
a. the USDA.
b. the FDA.
c. the Bureau of Alcohol, Tobacco and Firearms (BATF).
d. the certifying agency.

6. Products regulated by the USDA are not mandated to abide by FALCPA.
a. True
b. False

7. It could be possible to find products labeled gluten free with wheat on the label, according to FALCPA and the proposed gluten-free labeling requirements.
a. True
b. False

8. For products “rendered gluten free,” the World Health Organization and Codex state:
a. they may be labeled gluten free.
b. they may not be labeled gluten free.
c. they may contain between 20 and 100 parts per million gluten.
d. b and c

9. The FDA will allow terms such as the following to be synonymous with gluten free:
a. Free of gluten
b. Without gluten
c. No gluten
d. All of the above

10. COOL is required on products regulated by:
a. the FDA.
b. the USDA.
c. the BATF.
d. All of the above