- From: Andre@happyfamilybrands.com
Date: 11 Jan 2012
Subject: A Response to your Petition regarding GMOs in Organic Baby Food
- Dear Concerned Consumer,
- We appreciate your continued interest in our HAPPYBELLIES cereal.
- We have talked with many of you on the phone and explained how the Organic Consumer's Association is presenting misleading information. Many of you have asked to be removed from the OCA list emails as a result of the organization's actions to use the internet and provide partial information to misconstrue the truth.
- There are essentially two misconceptions that the OCA is alleging regarding our use of DHA in our HAPPYBELLIES Organic whole grain cereals.
- First, that this oil is obtained from organisms that are genetically modified by disallowed methods according to any standard, US, European, or Canadian.
- Recently, the U.S. National Organic Standards Board (NOSB) determined that the DHA produced by DSM and used in HAPPYBELLIES is not the product of genetically modified organisms or processes. The NOSB is the citizen advisory board created by the U.S. Congress to oversee the most stringent non-GMO policy under U.S. Federal law. The NOSB classified HAPPYBELLIES DHA as "non-synthetic" and reconfirmed its use in certified organic products.
This transcript of Friedman's statement was made from the archived webcast of the NOSB meeting:
Tracy: "Are we approving dried powder or just oil? Is the material used in the product described by Ms. Rolph among the materials petitioned for the National List?"
Dr. Salem: "I've got some help here"
Friedman: "I can answer that. That's not the petitioned material."
Tracy: "Thank you."
Nick: "Could you please identify yourself for the record?"
Friedman: "William Friedman, counsel for Martek, I filed the comment for Martek, for Covington and Burling."
Tracy: "OK, so for the record, the material that was passed around to the Board yesterday is not part of the pending matter of this Board or part of the proceedings."
Organic Caucus chair Congressman Sam Farr confirmed this in a letter to constituents stating:
"there is one strain of the DHA-producing algae that has been genetically engineered"
"that is not the strain that was approved by the NOSB," and
the DHA approved by the NOSB is "not the kind used in infant formula and baby cereals."
The only conclusion to draw from this statement is that the DHA used in organic infant formula and baby cereals, including HAPPYBELLIES, is from the strain of DHA-producing algae that has been genetically engineered and this DHA was not approved by the NOSB.
The HAPPYBELLIES letter continues:
- In response to allegations that the sources of the DHA we use in HAPPYBELLIES are the product of genetic manipulation, the NOSB directed a question to the USDA's National Organic Program ("NOP") staff regarding the scope of its prohibition on such practices. The government's answer was unequivocal - the traditional breeding and selection methods used by DSM for its algae are accepted practices under the U.S. federal organic regulations that prohibit recombinant genetic technology.
- Following the four-day public meeting, on December 2, 2011, the NOSB board voted, by an overwhelming majority, to recommend DHA from algal oil for inclusion on the National List of Allowed Substances. The NOSB also recommended that the classification of DHA on the National List be non-synthetic. The National List includes a specific list of vitamins, minerals, and nutritional supplements that may be used in organic products. The board's recommendation rejected the claims that DSM's products are the product of prohibited methods and ratified the existing U.S. policy to allow the use of algal DHA in certified-organic food and beverage products.
I spoke to National Organic Program director Miles McEvoy in person at the meeting to share my concerns that the HAPPYBELLIES DHA is GMO. He let me know that the issue had not been investigated, but promised me that it would be, whether or not the National Organic Standards Board made a decision to approve DHA at the meeting.
Later, when I gave my testimony to the Board, sharing with them the evidence that led me to question whether the DHA is GMO, Board Chair Tracy Miedema asked McEvoy on the record whether the GMO issue had been investigated. McEvoy admitted that it had not and another National Organic Program staff person confirmed that the Program had simply taken DSM's word that the product was non-GMO, without asking for any evidence to back up their claim.
The National Organic Standards Board approved the DHA on the assumption that it was non-GMO. As a legal matter, the NOSB has approved a non-GMO version of DHA. But, as a matter of fact, it is still unknown whether the DHA that is currently being used by HAPPYBELLIES is non-GMO.
National Organic Standards Board approval is not the final step for the inclusion of new ingredients in organic. The NOSB decision must be codified through National Organic Program regulations. The NOP has not yet published regulations on the approval of DHA. When it does, they will have to review the evidence that DSM produces DHA through the use of genetic engineering. It may be that there are GMO and non-GMO versions of DHA currently in the marketplace. The National Organic Program will have to provide information to certifiers and manufacturers that helps them to identify non-GMO DHA, if it is available.
The Happy Bellies letter continues:
- OCA either does not understand, or chooses to ignore the key pieces of scientific thought, and thus did not / cannot properly educate its members about the differences between classical mutagenesis, whose methods are centuries old and allowed by the organic standards, and those methods specifically disallowed, such as site directed techniques, and other techniques which introduce encapsulated genetic targets for insertion into the genome.
- Let us explain: Classical mutagenesis is a method of plant breeding. This method does not introduce any foreign genetic material to the plant organisms, but instead uses mutagens - for example, ultraviolet light - to increase the rate of mutation that naturally takes place in plant organisms. Classical mutagenesis is not considered genetic modification by any legal or regulatory body and has been used for generations in agriculture.
- Because of classical mutagenesis techniques, we have many varieties of heritage tomatoes, corn, and numerous other fruits and vegetable species that have been around for hundreds of years. Classical mutagenesis techniques simply "show us" what the organisms are capable of doing when their existing genes are allowed to express themselves fully. Selecting and putting to use those expressed traits we consider most useful and most valuable is how these plant and animal lines have come into worldwide, commercial use, including the organic sector.
- The list of "excluded methods," however, includes direct, targeted irradiation and gene manipulation or modification.
The DHA patents describe a range of possible methods of genetic modification from mutation to recombination.
DSM's website boasts the invention of modern extensions of this process, including "site-directed mutagenesis technology." DSM screens the vast numbers of microbial strains produced by random mutagenesis and selects for improved properties using a robotic High-Throughput Screening (HTS) facility which automates analytical tasks, including complex enzymatic analyses and high-tech flow-injection Nuclear Magnetic Resonance. Then, they use recombinant-DNA technology to combine multiple mutations in a single organism.
It is incumbent on DSM to provide information on the methods it used to produce its DHA. If it used mutagenesis, it is important to identify what kind of radiation or chemical was used to induce it and whether this use comports with organic principles. It is also important to have data on undesirable traits produced due to the mutagenesis.
The HAPPYBELLIES letter continues:
- In the Final Rule, the term "microencapsulation" was discussed in the context of methods commonly used to genetically modify organisms and it appears on the list of prohibited methods. This prohibited method is a technique used for the encapsulation and direct incorporation of foreign heritable genetic material into a receptor cell to generate an organism with recombinant genetic material. Again, the DHA used in HAPPYBELLIES is not made from algae produced by this method.
- On this subject, the other predominant shortcoming of the OCA allegations is their use of the term "microencapsulation", and leading consumers to believe that any microencapsulation techniques are prohibited. Again, this is not the case.
- As stated above, microencapsulation for the purpose of gene insertion and modification is disallowed by the organic standard.
- Microencapsulation for the purpose of including vitamins, minerals, and other
nutritional supplements to a consumer in a food product are not only allowed, but
- Most vitamin and minerals used to fortify foods are micro-encapsulated to prevent their oxidation and degradation during processing. Iron, perhaps one of the most commonly micro-encapsulated minerals, is most usually encapsulated, because it is a known active oxidant, and will cause a product to go rancid if not stabilized by encapsulation.
- Microencapsulation not only ensures that the vitamins and minerals do not degrade food's flavor, texture, and color, it also ensures that the vitamins and minerals are biologically available through the digestive processes of an infant, child, or adult.
- This type of microencapsulation plays a major role in food and beverage products and is widely used in the food industry but again, has nothing whatsoever to do with genetic engineering.
The definition of "excluded methods" prohibits "microencapsulation":
Excluded methods. A variety of methods used to genetically modify organisms or influence their growth and development by means that are not possible under natural conditions or processes and are not considered compatible with organic production. Such methods include cell fusion, microencapsulation and macroencapsulation, and recombinant DNA technology (including gene deletion, gene doubling, introducing a foreign gene, and changing the positions of genes when achieved by recombinant DNA technology). Such methods do not include the use of traditional breeding, conjugation, fermentation, hybridization, in vitro fertilization, or tissue culture.
Whether microencapsulation is an excluded method or not, the fact remains that DSM has not disclosed to the National Organic Standards Board, the National Organic Program or organic consumers any information about the materials and methods it uses to microencapsulate DHA and ARA.
Like mutagenesis, microencapsulation is a modern, evolving technology that cannot be assumed to be compatible with organic principles.
The food industry is notoriously secretive about its use of novel technologies like microencapsulation. A rare window on the world of food science was opened by The Times (London) writer Alex Renton in his article, The Frankenfood that Improves You. In the article, Renton describes a food science trade show promoting nutraceuticals like DHA and ARA. He quotes a DSM representative who calls his interest in the ethical concerns raised by these products "petty."
Modern forms of microencapsulation, pioneered by the pharmaceutical industry, utilize nanotechnology to transform oils into powder and stabilize them for longer product shelf life. Edible substances are sometimes coated with inorganic nano particles of non-food substances like titanium dioxide.
The danger of nano particles is that they are small enough to penetrate the skin, lungs and pass through the protective blood-brain barrier. Nano-titanium dioxide has been proven to cause disease in test animals that have been exposed to high doses. One study at UCLA repeatedly showed damage or destruction to the animals' DNA and chromosomes.
In 2010, the National Organic Standards Board passed a recommendation urging the National Organic Program to prohibit engineered nanomaterials from certified organic products as expeditiously as possible.
For more information on the use of nanotechnology in modern microencapsulation, please read:
Tiny, Invisible Ingredients
Top 10 Reasons for Using Nanotech in Food
Many Eager to Use Nano in Food, But Few Admit It
Regulated or Not, Nano-Foods Coming to a Store Near You
The HAPPYBELLIES letter continues:
The reason we have chosen to keep DHA in our HAPPYBELLIES cereal is because parents have continually asked us to create an optimal products that promote their babies health; DHA specifically promotes brain and eye development in infants.
Our Response: Since 2008, the Cornucopia Institute has been documenting evidence that puts the safety of DHA and ARA, and the health claims used to market them, in question. Their report, "Novel Oils in Infant Formula and Organic Foods: Safe and Valuable Functional Food or Risky Marketing Gimmick?" states:
FDA scientists who reviewed the novel oils have never affirmed their safety. Included among FDA's reasons for not affirming the safety of these novel oils are the following issues:
Some studies have reported unexpected deaths among infants who consumed formula supplemented with long-chain polyunsaturated fatty acids. These unexpected deaths were attributed to sudden infant death syndrome (SIDS), sepsis or necrotizing enterocolitis. Also, some studies have reported adverse events and other morbidities including diarrhea, flatulence, jaundice, and apnea in infants fed long-chain polyunsaturated fatty acids.
The European Union has made it illegal for companies to mislead consumers with unsubstantiated health claims about DHA and ARA supplemented foods. Specifically, the E.U. banned the very claim Happy Bellies makes, that "Docosahexaenoic acid (DHA) and arachidonic acid (ARA) contribute to the optimal brain development of infants and young children."
The HAPPYBELLIES letter concludes:
- DHA used to be more prevalent in our diets. The typical consumer does not have access to eggs from worm-eating chickens, nor do all consumers regularly eat wild fish or organ meats, and not all babies are breastfed into toddlerhood. We feel good about the DHA we use because it is a sustainable, vegetarian source from non-GMO organisms, and is free of ocean-borne contaminants and does not contribute to overfishing. It is also the only source of DHA we can use because of the specific process we use to make our dry cereal; there are no other viable alternatives for us at this time.
- We hope this additional information helps clear up the recent confusion OCA has caused, and of course, invite consumers to email further questions to us.
- Shazi Visram
HAPPYFAMILY | Founder & CEO
139 Fulton St. Ste. 907
New York, NY 10038
O: (212) 374-2779
F: (212) 602-0104
In addition to the points discussed above, there is another issue related to DHA being produced with the use of excluded methods. A Martek statement admits that they raise their algae on GMO corn:
"Martek does use domestic corn-based nutrients in the DHA production process to facilitate fermentation that may be sourced from a GM corn plant given the prevalence of GM corn in the U.S. market, but the use of GM ingredients during the fermentation process does not alter the genetic makeup of the algae, and Martek's DHA product is not GM and contains no GM material."
It is illegal to raise organic animals on genetically engineered feed. Just as an organic egg may not come from a chicken that is fed GMO corn, organic DHA shouldn't come from algae that's fed GMO corn.
DSM/Martek has perpetrated a horrible fraud on the organic community, manufacturers and consumers alike, by forcing this product to market before it was reviewed for compatibility with organic standards. HAPPYBELLIES is a victim of this fraud, but if HAPPYBELLIES truly cares about meeting organic consumers expectations that its products are non-GMO, it should seek the information DSM/Martek has refused to disclose:
- If the DHA is produced through the mutation of microorganisms, or another modification that didn't happen under natural conditions, what processes and materials were used to trigger the mutations? How were those mutations screened? How were the mutations selected? How were the mutations incorporated into the DHA-producing strain? Were undesirable mutations recorded? If so, were the undesirable traits avoided in the selected strain and how? What information is available on the impacts of introducing these mutations into the environment and the human body? What information is available on the health and environmental impacts of the processes and materials used in creating the DHA-producing algae?
- If the DHA is microencapsulated, what processes and materials were used? Were any of the materials nanoscale? What information is available on the health and environmental impacts of the materials and processes used to microencapsulate the DHA? What information is available on the health impacts of consuming microencapsulated DHA?
- If the DHA comes from algae raised on genetically engineered corn, why should microorganisms used to produce food ingredients be treated differently from animals, which cannot be given any amount of genetically engineered feed?
DHA and ARA are the first nutraceueticals the organic program has had to contend with, but they won't be the last. We need a fact-finding process at the NOSB and NOP that can readily identify products that may have been made using excluded methods and accurately describe the materials and processes used to produce novel foods. Consumers have a right to know what's in our food and the organic law must guarantee it.