Comments on draft GE labeling rule

U.S. Department of Agriculture
Agricultural Marketing Service
1400 Independence Avenue SW
Washington, D.C. 20250

Docket No. AMS-TM-17-0050
Re: comments from PCC Community Markets on proposed regulations to implement the National Bioengineered Food Disclosure Standard

 

Dear Secretary Perdue,

PCC Community Markets is pleased for the opportunity to comment on the U.S. Dept. of Agriculture’s (USDA’s) proposed regulations for the National Bioengineered Food Disclosure Standard (NBFDS, Pub. L. 114-216).

PCC Community Markets is the largest grocery chain in the United States that is owned and operated by consumers, the people who shop our stores. More than 59,000 consumers own our 11 stores, which generate nearly $280 million in annual sales. We are accountable to consumers — not outside investors — and we have a long history of advocating the consumer’s interest in high standards for food and body care products. We have advocated full disclosure of all product ingredients, as well as transparency in labeling how foods are produced. Shoppers demand this.

On behalf of the 250,000 consumers who shop our stores each month, PCC Community Markets urges USDA to adopt a disclosure standard for genetically engineered (GE) foods that uses terms and symbols that are familiar, understandable and comprehensive, including any and all foods produced with new and emerging genetic engineering (GE) techniques. We ask USDA to create a standard that identifies each GE ingredient specifically in ingredient lists.

Consumers need terms and symbols for disclosure that enable them to make informed choices about the foods and body care products they purchase. The terms and symbols must address what consumers consider important. The terms and symbols must not mislead or deceive consumers.

The terms and symbols for disclosure on packages should be familiar and neutral. USDA’s proposed symbols and terms are neither neutral nor familiar. Consumers do not trust product labels that suggest bias.

We urge disclosures that are accessible equally to all — regardless of age, income or where a person lives. We object to off-package forms of disclosures, which are not allowed by the Food and Drug Administration, still the lead agency for most food labeling.

Here are specific details of key consumer concerns.

I. The term “bioengineered” and the acronym “BE” are confusing and misleading to consumers.

Bioengineered and BE are completely unfamiliar and are not recognized by consumers, retailers, or the food industry. They do not match the terms that already are widely adopted, accepted and used throughout the U.S. food industry and by federal regulators.

Consumers, retailers and manufacturers have used the terms, GE and GMO, for 30 years. GE and GMO are understood and broadly accepted. We ask USDA to require them to continue to be used.

Allowing and requiring continued use of “GE” and “GMO” also would ensure consistency with current federal policy.

• • USDA’s Food Safety and Inspection Service uses “GE” and “GMO” in addition to “bioengineered” in recent guidance for companies that make labeling claims.1
  • USDA uses “genetic engineering” and “genetic modification” in its regulations for plants produced using biotechnology.2
  • FDA states that it considers “genetic engineering” (GE) to be the more precise term, although it acknowledges that some recognize and use “genetic modification” and “genetically modified organisms or GMOs.” 3

Introducing novel, unfamiliar terms suggests intent to portray BE as different from genetic engineering, which would be misleading and confusing to consumers. It also would cause unnecessary confusion and disruption in retail markets, such as ours, where customers would ask for an explanation.

USDA should require continued use of the well-established terms “GE” and “GMO” that already are widely understood and well accepted by U.S. consumers and the markets.

II. Require neutral symbols.

The symbols proposed by USDA are not acceptable because they look like emoticons used to express a feeling or mood. They clearly suggest GE foods are safer, happier or better than non-GE foods.

Under the law, in fact, USDA must require content-neutral symbols. The statute expressly prohibits suggesting GE foods are better:

For the purpose of regulations promulgated and food disclosures made … a bioengineered food that has successfully completed the pre-market Federal regulatory review process shall not be treated as safer than, or not as safe as, a non-bioengineered counterpart of the food solely because the food is bioengineered or produced or developed with the use of bioengineering.
     – Sec, 293, Establishment of national bioengineered food disclosure standard, (b) (3) Safety

Smiley-sun faces with a winking eye, or bucolic landscapes are not neutral.

The most understandable symbol for GE foods would be a double-helix with USDA printed below it in a circle. The double helix is the most directly relevant factual symbol of the technology being disclosed. Alternatively, consumers could accept the letters “GE” or “GMO” in a circle (as proposed by the National Organic Coalition) as clear and neutral.

It would be wrong for USDA to allow biased GE food symbols while requiring a neutral, value-free message for USDA Organic. As a member of the National Organic Coalition (NOC), we understand NOC was instrumental in developing the USDA Organic label and that the USDA Organic seal was required to be wholly neutral and value-free.

We strongly object to any double standard at USDA that would allow a biased symbol for GE foods while requiring a neutral one for organic foods. Consumers want facts, not judgement or propaganda, at the point of sale.

III. Reject QR codes and other discriminatory alternatives to on-package disclosure.

The retail food market and consumers expect consistent food labeling standards, as established over many decades largely by FDA as the lead agency for food and body care labeling.

One fundamental FDA labeling principle is that information considered a “material fact” or of “material” interest to consumers must be printed on the package as an “on-package disclosure (or, in the case of raw commodities, such as produce, on signage at the point of sale).

FDA’s rule for consistent on-package disclosures ensures all shoppers have equal access to “material” product information, enabling everyone to make informed shopping decisions regardless of income, age or where they live.

Introducing novel forms of off-package disclosures, such as QR codes or websites, contradicts FDA’s on-package rule and conceivably could be interpreted by consumers as not important. Off-package disclosures also would place an unreasonable burden on consumers — and retailers.

We are aware USDA’s own 2017 study found that QR codes would discriminate against poor, elderly or rural consumers who do not have smartphones or reliable internet connections. We are aware USDA’s study found nearly one-in-four Americans don’t own a smartphone and three-in-four don’t know they can scan QR codes to get product information. Most never have scanned a code to get food information, and 85 percent who have tried say they struggled with mobile scanning apps. We have seen this among customers in our stores. Poor or non-existent cell service in many areas means it can take a long time for GE information to load – if it loads at all.4

Retailers, such as PCC, would be under great pressure to provide in-aisle scanners at considerable cost so all shoppers would have access to off-package disclosures. Scanners in-store also would take up valuable floor space that should be dedicated otherwise. Disclosure is the producers’ and manufacturers’ responsibility. It should not become the responsibility of — or a burden on — retailers.

QR codes and websites would create an onerous and costly burden on retailers. They are not transparent or equitable and we believe they could prompt consumer lawsuits for failing to ensure equal access.

IV. All processed and refined foods produced with genetic engineering should be labeled GE.

Consumers have been demanding to know how foods are produced — not only what they contain — since nutrition fact labels were required by FDA in 1990, and even more since GE recombinant bovine growth hormones (rBGH) entered the dairy industry in 1994. Since then, consumers increasingly have asked questions about how a product is made, beyond the list of ingredients, to enable them to make informed choices. In the case of GE, they want each GE ingredient to be identified in the ingredient panel, as is the rule in many other countries.

A lack of producer transparency created the massive nationwide demand for GE food labeling and the passage of four state laws. The demand has not diminished. A failure to label all foods produced with genetic engineering — no matter what today’s science can discern in the final product — will be misleading and confusing to consumers. Consumers do not tolerate being deceived or misled and, when they are, they tend to punish brands in the marketplace.

If the NBFDS scope is so narrow that it excludes highly refined foods and foods produced with emerging forms of genetic engineering, we believe the Non-GMO Project and USDA Organic would become even more relevant. Consumers could not assume a food without a USDA bioengineered label is automatically non-GMO.

Industry argued until very recently that culinary oils from GE crops should not be labeled because tests could not find GE markers in the final product. Now, refined oils are testable. It is only a matter of time before testing techniques can identify GE content in other highly processed foods, such as sugar from GE sugar beets.

Exempting highly processed and refined products from the scope of the NBFDS is very likely to be viewed by consumers as intentional deception, especially as testing techniques improve and detect telltale GE markers. It would be best to include all foods produced with GE techniques now, so USDA is not forced to self-correct when refined sugar and other highly processed foods are testable.

V. Foods produced with new forms of genetic engineering must be included in the scope of labeling to maximize international trade and meet consumer expectations.

USDA must ensure foods made with new and emerging forms of genetic engineering, such as synthetic biology, gene editing (CRISPR) and interference (RNAi), are required to be labeled. Companies are experimenting now with CRISPR in oranges, cacao, potatoes, soy, and canola.

Consumers certainly will expect these GE foods produced with newer technologies to be labeled — especially since the journal, Nature Medicine, published not just one but two studies in June 2018 showing CRISPR may be carcinogenic.

• • See the study by the Karolinska Institute, Stockholm, Sweden, “CRISPR-Cas9 genome editing induces a p53-mediated DNA damage response,” published in June 2018, at https://www.nature.com/articles/s41591-018-0049-z.
  • See the study by the Novartis Institutes for Biomedical Research, Cambridge, Massachusetts, “p53 inhibits CRISPR-Cas9 engineering in human pluripotent stem cells,” at https://www.nature.com/articles/s41591-018-0050-6.

These two recently published studies finding CRISPR may be carcinogenic would make CRISPR technology in food a “material fact” of consumer interest under FDA precedent, requiring labeling. Not labeling CRISPR foods would constitute mislabeling because of the importance to consumers.

Failure to require disclosure of food produced with new forms of biotechnology also would conflict with existing federal definitions. We urge USDA to follow FDA’s precedent and allow the term, “modern biotechnology” as interchangeable with “bioengineering.”

The term “modern biotechnology” is accepted at FDA and has a common, globally accepted standard definition, noted by the Codex Alimentarius Commission and the Convention on Biological Diversity.

The standards and guidelines5 adopted by Codex are used by the World Trade Organization as the authoritative resource for settling international trade disputes. Their definition of modern biotechnology6 includes new gene editing techniques, including CRISPR and RNAi:

i. Modern biotechnology:
(i) in vitro nucleic acid techniques, including recombinant DNA and direct injection of nucleic acid into cells or organelles, or
(ii) fusion of cells beyond the taxonomic family, that overcomes natural, physiological reproductive or recombination barriers, and that are not techniques used in traditional breeding and selection.
     – Principles of Risk Analysis of Foods Derived from Modern Biotechnology,
     adopted by Codex Alimentarius Commission, 2003

Failure to disclose foods produced with new forms of biotechnology would create trade conflicts with other countries. Most countries that require GE food labeling require foods produced with new biotech techniques (including gene silencing or deletion via RNAi and CRISPR) to be labeled as GE.7 Failure to disclose them would hit our state, Washington state, particularly hard, as agriculture is Washington’s #1 employer and is the most trade-dependent state in the country.

V. USDA disclosure must be compatible and consistent with international standards.

Grocers, such as PCC Community Markets, rely on global supply chains to source foods, stock stores, and meet consumer needs. U.S. disclosure regulations must be consistent with international standards to reduce manufacturer, retailer and consumer confusion and to maximize international trade.

The standards and guidelines adopted by Codex Alimentarius and recognized by the World Trade Organization should be used by USDA. At its 39th session in 2011, the Codex Committee on Food Labeling adopted labeling standards for genetically engineered foods and advised:

Different approaches regarding labelling of foods derived from modern biotechnology are used. Any approach implemented by Codex members should be consistent with already adopted Codex provisions.
     – U.N. Doc. Rep. 11/FL (2011)

As a participant in Codex and WTO, the U.S. should adopt a threshold for inadvertent GE presence that is consistent with the thresholds established by other major food labeling laws. The 0.9 percent threshold is well established as the standard for labeling in the European Union and aligns with standards used by many U.S. food companies today that sell to overseas market.

PCC urges USDA disclosure to be required when any ingredient containing inadvertent or technically unavoidable GE material accounts for 0.9 percent of the specific ingredient. Testing protocols should identify GE content in individual ingredients, which cannot be extrapolated to represent a weight in the finished product.

Testing to determine GE content should be conducted using Real-Time or Digital PCR method and conducted by an ISO 17025 accredited laboratory. Testing to establish GE content must be conducted on a sample where appropriate laboratory controls indicate the DNA of the sample is sufficiently intact to allow for valid quantitative analysis using PCR.

A “non-detect” result based on a test of a highly refined ingredient is not an adequate basis for exemption from labeling. Records must show that a valid sampling plan was employed in accordance with industry standards (e.g. GIPSA). Tests must demonstrate GE content of less than 0.9 percent for all ingredients for a product to be exempt from labeling.

Consumers, in our experience, are strongly opposed to higher thresholds, believing they are meant to allow purposeful GE presence. A 5 percent threshold also would exempt many, if not most, GE foods. It would exacerbate consumer confusion and distrust that the NBFDS delivers what it promised.

A 5 percent threshold also is not accepted by most major trade partners. It would hurt trade and raise consumer doubt in trusting the U.S. standard.

VI. Retailers need disclosure without delay.

The U.S. food market has been ready to accept GE food labeling for more than two years, since four state laws were passed, especially since Vermont’s GE labeling law took effect in the summer of 2016. Many U.S. food companies, large and small, already are labeling their foods as products of genetic engineering. We have not heard any pushback from vendors claiming they cannot comply.

The food industry has had more than ample time to prepare to be transparent in what they’re selling to American consumers. Vendors know what ingredients in their products are GE and food companies routinely relabel their products, on average, every 18 months. It is not burdensome nor costly to declare the ingredients they use when they are relabeling their products anyway.

Allowing companies to postpone GE labeling for as long as another four years is unnecessary, unreasonable, and would betray American consumers and retailers who trusted the law would be implemented, as approved, in July 2018.

VII. Summary

The National Bioengineered Food Disclosure Standard is an opportunity for the United States to grow our agricultural economy and expand trade with a rule that meets global expectations and U.S. consumer needs. As a consumer-owned grocer, we appreciate the work by many committed USDA staff to create these regulations.

We urge USDA to adopt a GE food labeling rule that honors the consumers’ need for familiar, understandable terms and symbols and that will provide transparent on-package disclosure, ingredient by ingredient, when produced with genetic engineering.

On behalf of our 59,604 member-owners and the 250,000 people who shop our stores, we value the opportunity to comment.

Thank you sincerely,

Trudy Bialic
Director, Public Affairs & Quality Standards

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