: WHO study raises biotech food concerns + FDA spins facts to Congress

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In a message dated 6/25/2005 5:38:25 A.M. Eastern Daylight Time, newsupdate writes:

News Update From The Campaign ----------------Dear News Update Subscribers,WHO REPORT ON BIOTECH FOODSThe World Health Organization (WHO) released a report on Thursday that callsinto question the current safety oversight of genetically engineered foods.The report titled "Modern food biotechnology, human health and development:an evidence-based study" calls for case-by-case risk assessment of each newbiotech food on its effects on human health. It also emphasizes theimportance of long-term monitoring to catch any possible adverse effects.Similar to other safety review studies on genetically engineered foods, thisWHO report raises many concerns over the current safety testing methods, butdoes not suggest that the biotech foods now being sold may be causing healthproblems. (Perhaps the authors of these reports don't want to alarm consumers by suggesting there was inadequate review of existing crops?)While The Campaign is glad that the World Health Organization is raising concerns over the current testing and monitoring methods, we don't agree that the biotech crops now being consumed should be assumed to be safe. WHO states that thecurrent crops have had pre-market risk assessments. But these risk assessmentshave been done by the biotech companies themselves. Where are the safety studies that prove the current biotech crops are indeed safe? They don't exist.There may be low level allergic reactions taking place in tens of thousandsof people who are currently eating genetically engineered foods. But withoutlabeling, it is extremely difficult for the Centers For Disease Control todiscover patterns of low level allergic reactions.NAS REPORT RAISED THE SAME CONCERNSLast July, the National Academy of Sciences (NAS) issued a report titled"Safety of Genetically Engineered Foods: Approaches to Assessing UnintendedHealth Effects."The NAS report had similar findings and concerns as the WHO report. The NASreport stated: "There is a need, in the committee's judgment, for a broadresearch and technology development agenda to improve methods forpredicting, identifying, and assessing unintended health effects from thegenetic modification of food." FDA SPINS THE DATA TO CONGRESSIn spite of numerous reports criticizing the oversight of geneticallyengineered foods, the U.S. Food and Drug Administration refuses to acceptthere are problems with the current regulatory scheme.Last week the Director of the FDA's Center for Food Safety and AppliedNutrition, Robert E. Brackett, Ph.D., testified before the U.S. SenateCommittee on Agriculture, Nutrition and Forestry about the FDA's regulatoryprogram for genetically engineered foods.Rather than acknowledging the findings of the NAS report and others aboutthe need for significant improvements in the oversight of geneticallyengineered foods, Brackett assured the Senate committee that everything wasworking great with the current system.It was particularly disturbing that Brackett said the NAS report found thatgenetically engineered foods "are as safe as their conventionalcounterparts." Actually the NAS report stated that the likelihood of"unintended genetic effects" were significantly higher in geneticallyengineered foods. They even had a chart showing this on page 64 of the NASreport. Next month The Campaign will put together an ACTION ALERT to the SenateCommittee on Agriculture, Nutrition and Forestry pointing out how DirectorBrackett misrepresented the facts contained in the NAS report when hetestified before them. And we will point out that the new WHO report raisedthe same concerns as the NAS report about the need for better riskassessment and safety monitoring.THE FDA CONTINUES TO REFUSE TO ACCEPT THE FACTSIt was disappointing that FDA administrators never listened to concerns oftheir own scientists when they set up the original regulations forgenetically engineered foods in 1992. At that point in time, FDA scientistsrecommended that each crop should be reviewed on a case-by-case basis. Butinstead, the administrators ignored the concerns of their own scientists andstated that genetically engineered foods are "substantially equivalent" toconventional crops and need no special testing or labeling (unless the cropscontain a known allergen or have a significantly altered nutrient content). And now that several of the most respected scientific bodies in the worldhave called for better pre-market testing and post-market monitoring, theFDA continues to argue that the current system is working fine and does notneed to be changed. READ THE REPORTS YOURSELFPosted below is an article from the Food Navigator - USA web site titled"Health effects of GM foods need further study, WHO says."If you want to read the actual World Health Organization report titled"Modern food biotechnology, human health and development: an evidence-basedstudy" visit the following web page:http://www.thecampaign.org/who062305.pdfIf you want to read the National Academy of Sciences report titled "Safetyof Genetically Engineered Foods: Approaches to Assessing Unintended HealthEffects" visit the following web page:http://www.thecampaign.org/nas0704.htmIf you want to read the testimony of the Director of the FDA's Center forFood Safety and Applied Nutrition, Robert E. Brackett, Ph.D., before theU.S. Senate Committee on Agriculture, Nutrition and Forestry about theregulation of genetically engineered foods, it is posted below. Or you mayread it at the FDA's web site at:http://www.fda.gov/ola/2005/bioengineered0614.htmlContrary to what Director Brackett stated to Congress, the regulation ofgenetically engineered foods in the United States is entirely inadequate. Atthe very least, we need all genetically engineered foods to be labeled andsafety tested. Craig WintersExecutive DirectorThe Campaign to Label Genetically Engineered FoodsThe CampaignPO Box 55699Seattle, WA 98155Tel: 425-771-4049E-mail: labelWeb Site: http://www.thecampaign.org Mission Statement: "To create a national grassroots consumer campaign forthe purpose of lobbying Congress and the President to pass legislation thatwill require the labeling of genetically engineered foods in the UnitedStates."*************************************************************** Health effects of GM foods need further study, WHO saysFood Navigator - USA6/24/2005http://www.foodnavigator-usa.com/news/printNewsBis.asp?id=60866A call by the World Health Organisation for further safety assessments onusing genetically modified (GM) foods should give governments pause forthought before giving their approval for their wider use of the technology.In a report issued yesterday, the UN body finds that GM foods can increasecrop yield, food quality and the diversity of foods that can be grown in agiven area but warns against rushing to introduce novel types of genes intothe food chain.The WHO report further complicates the international dispute over GM foodswhich has left multinational companies with having to deal with differentsets of regulations depending on the countries in which they operate.The sale of GM foods has put nations at loggerheads with each other. The EUand Japan have enacted labelling and traceability requirements for GM foodproducts, while the US and Canada believe the technology is safe and thatsuch standards are not necessary. The US, Canada and Argentina have filedcases with the World Trade Organisation against the EU's requirements.WHO calls for a case-by-case risk assessment of each new GM food on itseffects on human health, on the food chain and on the environment ratherthan a general endorsement by governments on the use of the technology tocreate new types of crops or animals.WHO notes that pre-market risk assessments have been performed on all GMfood products that are currently marketed. To date, the consumption of GMfoods has not caused any known negative health effects. Currently,evaluations of GM primarily focus on the ecological and agriculturalramifications and on possible health effects."However, some of the genes used to manufacture GM foods have not been inthe food chain before and the introduction of new genes may cause changes inthe existing genetic make-up of the crop," WHO stated in its assessment."Therefore, the potential human health effects of new GM foods should alwaysbe assessed before they are grown and marketed, and long-term monitoringmust be carried out to catch any possible adverse effects early."The organisation recommends such evaluations should be widened to includesocial, cultural and ethical considerations, to help prevent what WHO callsa "genetic divide" between groups of countries which do and do not allow thegrowth, cultivation and marketing of GM products."Each country has different prevailing social and economic conditions, andthe people have different histories of what they eat and what food means intheir society," WHO stated. "All of these factors can affect how GM foodswill be regarded, and taking proper account of these concerns will affectthe long-term acceptance or rejection of GM foods and their possible healthbenefits and potential risks."There are now 15 international legally-binding instruments and nonbindingcodes of practice addressing aspects of GM organisms. Many developedcountries have established specific pre-market regulatory systems requiringthe rigorous case-by-case risk assessment of GM foods prior to theirrelease. Many developing countries lack the capacity to implement a similarsystem, WHO stated.In 2004 about 81m hectares of land was being used to grow GM crops by sevenmillion farmers in 18 countries, mainly the US, Argentina, Canada, Brazil,China, Paraguay and South Africa.The first major GM food was introduced on the market in the mid-1990s andpaved the way for the growing of strains of maize, soybeans, rapeseed andcotton. GM varieties of papaya, potato, rice, squash, sugar beet and tomatohave been released in certain countries. WHO estimates that at the end of2004 GM crops covered about four per cent of the total global arable land.Most of the GMOs commercialised so far in developing countries have beenacquired from developed countries and focus on a limited number of traits,mainly herbicide tolerance and insect pest resistance, and crops such ascotton, soybean and maize. Research is also underway on GM seafood andanimals.Many food-processing aids, such as enzymes, produced through the use of GMmicroorganisms have been on the market for over a decade and are used in awide variety of processed foods. No live GM food microorganisms have beenintroduced onto the market yet, WHO stated.Current EU requires that all food be tracked and labelled if it contains 0.9per cent or more traceable GM content, along with derivatives such as pasteand ketchup from a GM tomato. Products derived from GM processing aids, suchas GM enzymes or yeast, are not affected. Inciting strong criticism fromenvironmental groups, this year a panel of scientists at the European FoodSafety Authority (EFSA) cleared a variety of genetic maize known as 1507 forcultivation. Maize 1507 is made jointly by Pioneer Hi-Bred International, asubsidiary of DuPont, and Mycogen seeds, a Dow AgroSciences unit.Biotechnology, in its technical sense, refers to plant and animal farmingtechniques that alter living organisms to make or modify food products.There are many possible products from transgenic plants, plant parts, andprocessed foodstuffs, including highly refined substances such as vegetableoil containing little or no detectable transgene-derived protein or DNA.Under the Cartagena Protocol on Biosafety, governments will signal whetheror not they are willing to accept imports of agricultural commodities thatinclude GMOs by communicating their decision via an Internet-based BiosafetyClearing House.*************************************************************** Statement of Robert E. Brackett, Ph.D. Director, Center for Food Safety and Applied NutritionbeforeCommittee on Agriculture, Nutrition and ForestryUnited States Senate June 14, 2005 Introduction Mr. Chairman and Members of the Committee, I am Robert Brackett, Director,Center for Food Safety and Applied Nutrition at the Food and DrugAdministration (FDA or the Agency). Thank you for the opportunity to testifytoday on FDA's regulatory program for foods derived from bioengineeredplants, also known as genetically engineered, or bioengineered, foods. Background Within FDA, the Center for Food Safety and Applied Nutrition (CFSAN)oversees bioengineered plant-derived food and ingredients intended for humanconsumption. Our Center for Veterinary Medicine (CVM) oversees bioengineeredplant-derived products used as animal feed or as ingredients in animal feed,as well as bioengineered products used to improve the health or productivityof animals. My testimony this morning focuses on bioengineered plant-derivedfoods. Let me also clarify that in the Federal Food, Drug, and Cosmetic(FD & C) Act, food is defined as food for man or other animals. So, when Italk about food, it also encompasses animal feed unless stated otherwise. We believe it is very important for the public to understand how FDA isregulating the bioengineered foods being introduced into the marketplace andto have confidence in that process. Therefore, I appreciate this opportunityto describe our policies and procedures.First, let me state that FDA is confident that the bioengineered foods onthe United States market today are as safe as their conventionalcounterparts. This conclusion has been echoed in recent reports by theNational Academy of Sciences (NAS) and the Government Accountability Office,and most recently in a 2004 report from NAS's National Research Council andInstitute of Medicine entitled, "Safety of Genetically Engineered Foods:Approaches to Assessing Unintended Health Effects." Over the last ten years,FDA has reviewed the data on more than 60 bioengineered food products,ranging from herbicide resistant soybeans to a modified canola oil. To date,the evidence shows that these foods are as safe as their conventionalcounterparts. In a 1992 policy statement on bioengineered foods, FDA announced that theAgency was "not aware of any information showing that foods derived by thesenew methods differ from other foods in any meaningful or material way, orthat, as a class, foods developed by the new techniques present anydifferent or greater safety concern than foods developed by traditionalplant breeding." This 1992 statement and its scientific underpinnings stillreflect FDA's thinking about bioengineered foods. Crossbreeding, Hybridization, and BioengineeringThe selection and genetic improvement of plants for agricultural use hasbeen going on for thousands of years, although plant breeding as a scienceonly began in the late 1800s. Typically, plant breeding has involvedcrossbreeding and hybridization, in which two related plants arecross-fertilized, and the resulting offspring have characteristics of bothparent plants. In the breeding process, however, many undesirable traitsoften can appear in addition to the desirable ones. Some of thoseundesirable traits can be eliminated through additional breeding, which istime-consuming. Breeders can then further select and reproduce the offspringthat have the desired traits. Many of the foods that are already common inour diet are obtained from plant varieties that were developed usingconventional genetic techniques of breeding and selection. Hybrid corn,nectarines (which could be considered genetically altered peaches), andtangelos (which are a genetic hybrid of a tangerine and grapefruit) are allexamples of such breeding and selection. Today, by inserting one or more genes into a plant, scientists are able toproduce a plant with new, advantageous characteristics. The new genesplicing techniques are being used to achieve many of the same goals andimprovements that plant breeders historically have sought throughconventional methods. Today's techniques can be used with greater precisionand allow for more complete characterization and, therefore, greaterpredictability, of the qualities of the new variety. They give scientiststhe ability to isolate genes and introduce new traits into foods withoutsimultaneously introducing undesirable traits. This is an importantimprovement over traditional breeding. Any genetic modification technique,including both traditional methods and bioengineering, could change thecomposition of a food in a manner relevant to food safety. But because ofthe increased precision offered by the bioengineered methods, the risk ofinadvertently introducing detrimental traits is actually likely to belessened. Bioengineering does expand the range of new proteins and othersubstances that can be introduced into plants. However, the agencies havewell-established procedures for determining the safety of such newsubstances. FDA has found no evidence to indicate that deoxyribonucleic acid (DNA)inserted into plants using bioengineering presents food safety problems. Thesmall amounts of the newly expressed proteins are generally unlikely tochange the safety profile of the plant. If safety concerns should arise,however, they would most likely fall into one of three broad categories:allergens, toxins, or anti-nutrients. FDA has extensive experience inevaluating the safety of such substances in food.As to potential allergens, foods normally contain many thousands ofdifferent proteins. While the majority of proteins do not cause allergicreactions, virtually all known human allergens are proteins. Since geneticengineering can introduce a new protein into a food plant, it is possiblethat this technique could introduce a previously unknown allergen into thefood supply or could introduce a known allergen into a "new" food. FDA'sguidelines help developers to identify this issue and address any concernprior to marketing. A second possible problem is the introduction of toxins into the food crop.It is possible that a new protein could cause toxicity. A third possibleissue is the introduction of anti-nutrients, such as molecules like phyticacid that binds essential dietary minerals such as phosphorus. Breeding, whether bioengineering or otherwise, can cause unintended changesin the composition of the food. For example, it might result in a reductionof Vitamin C or an increase in the concentration of a naturally occurringtoxin in the food. Developers of bioengineered foods analyze the compositionof the foods from their new crop varieties to ensure that they do not marketfoods whose composition differs from conventionally-derived counterparts. It is important to note that the kinds of food safety testing typicallyconducted by developers of a bioengineered food crop to ensure that theirfoods meet all applicable requirements of the FD & C Act address thesepotential concerns. In the event that something unexpected does occur, thistesting provides a way to detect such changes at the developmental stage anddefer marketing until any concern is resolved. Legal and Regulatory Background The overall Federal regulatory structure for biotechnology products, knownas the Coordinated Framework, was adopted by Federal agencies in 1986 (51 FR23302, June 26, 1986). Under the Coordinated Framework, FDA regulatesbioengineered plant-derived food in conjunction with the United StatesDepartment of Agriculture (USDA) and the Environmental Protection Agency(EPA). FDA has authority under the FD & C Act to ensure the safety of alldomestic and imported foods for man or other animals in the U.S. market. Theexceptions to this are meat, poultry, and processed egg products, which areregulated by USDA. The safety of animal drug residues in meat and poultry,however, is regulated by FDA's CVM. Pesticides, including thosebioengineered into a food crop, are regulated primarily by EPA, whichreviews safety and sets tolerances (or establishes exemption from tolerance)for pesticides. FDA enforces the pesticide tolerances set by EPA. USDA'sAnimal & Plant Health Inspection Service (APHIS) oversees the agriculturaland environmental safety of planting and field testing of bioengineeredplants. Bioengineered foods and food ingredients must adhere to the same standardsof safety under the FD & C Act that apply to their conventionally bredcounterparts. This means that these products must be as safe as thetraditional foods on the market. FDA has broad authority to initiateregulatory action if a product fails to meet the requirements of the FD & CAct. FDA relies primarily on two sections of the FD & C Act to ensure the safety offoods and food ingredients that are produced using biotechnology:The adulteration provisions of section 402(a)(1). Under this postmarketauthority, FDA has the power to remove a food from the market (or sanctionthose marketing the food) if the food poses a risk to public health. It isimportant to note that the FD & C Act places a legal duty on developers toensure that the foods they market to consumers are safe and comply with alllegal requirements. The food additive provisions in section 409. Under this section, a substancethat is intentionally added to food is a food additive, unless the substanceis generally recognized as safe (GRAS) or is otherwise exempt (e.g., apesticide, the safety of which is overseen by EPA). Unapproved foodadditives are subject to the adulteration provisions in 402 (a)(2)© of theFD & C Act. The FD & C Act requires premarket approval of any food additive, regardless ofthe technique used to add it to food. Thus, substances introduced into foodare either: (1) new food additives that require premarket approval by FDA;or (2) GRAS, and are therefore exempt from the requirement for premarketreview by FDA. Generally, foods such as fruits, vegetables, and grains arenot subject to premarket approval under the FD & C Act because they have beensafely consumed over many years. Other than the food additive system, thereare no FDA premarket approval requirements for foods generally. In 1992, recognizing that bioengineered products were on the horizon, FDApublished a policy explaining how existing legal requirements would apply toproducts developed using the tools of biotechnology (57 FR 22984; May 29,1992; "Statement of Policy: Foods Derived from New Plant Varieties"). The1992 policy was designed to answer questions about these products and toassist developers prior to marketing to meet their legal duty to providesafe and wholesome foods to consumers. The basic principle of the 1992policy is that the traits and characteristics of the foods should be thefocus of safety assessment for all new varieties of food crops, no matterwhich techniques are used to develop them. Under FDA policy, a substance that would be a food additive if it were addedduring traditional food manufacturing is also treated as a food additive ifit is introduced into food through bioengineering of a food crop. Ourauthority under section 409 permits us to require premarket approval of anyfood additive and, thus, to require premarket approval of any substanceintentionally introduced via bioengineering that is not GRAS.Examples ofsubstances intentionally introduced into food that would bereviewed as food additives include those that have unusual chemicalfunctions, have unknown toxicity, or would be new major dietary componentsof the food. For example, a novel sweetener bioengineered into food wouldlikely require premarket approval. In our experience with bioengineered foodto date, however, we have reviewed only one substance under the foodadditive provisions, an enzyme produced by an antibiotic resistance gene(kanamycin), and we granted approval as a food additive. In general,substances intentionally added to or modified in food via biotechnology todate have been proteins and fats that are, with respect to safety, similarto other proteins and fats that are commonly and safely consumed in the dietand, thus, are presumptively GRAS. Therefore, they have not needed to gothrough the food additive approval process.In 1994, following the 1992 policy, FDA conducted a comprehensive scientificreview for the first bioengineered product planned for introduction into themarket. FDA reviewed Calgene's data on the Flavr SavrT tomato and the use ofthe kanamycin resistance marker gene. Calgene submitted food additivepetitions for the enzyme product of the marker gene for use in food andfeed. We subsequently approved the petitions. FDA also held a public meetingof our Food Advisory Committee to examine applicability of the 1992 policyto products such as the Flavr SavrT tomato. The Advisory Committee membersagreed with FDA that the scientific approach presented in the 1992 policywas sound and that the questions regarding the Flavr SavrT had beenaddressed. The Advisory Committee members also suggested that we provide anexpedited decision process for the marketing of bioengineered foods that donot raise substantive scientific issues.In response, FDA established a voluntary consultative process to helpcompanies comply with the FD & C Act's requirements for the bioengineeredfoods that they intend to market. The results of our consultation are publicinformation and are available on our website. Since the consultation processwas created, companies have used the consultative process more than 60 timesas they sought to introduce genetically altered plants representing morethan 16 different crops into the U.S. market. We are not aware of anybioengineered plant-derived food intended for commercialization that issubject to FDA's jurisdiction that has not been evaluated by FDA through thecurrent consultation process.Typically, the consultation begins early in the product development stage,before it is ready for market. Company scientists and other officials meetwith FDA scientists to describe the product they are developing. Inresponse, the Agency advises the company on what tests would be appropriatefor the company to assess the safety of the new food. After the studies are completed, the data and information on the safety andnutritional assessment are provided to FDA for review. The Agency evaluatesthe information for all of the known hazards and also for potentialunintended effects on plant composition and nutritional properties, sinceplants may undergo changes other than those intended by the breeders. Forexample, FDA scientists evaluate data and information to assure that thenewly expressed compounds are safe for food consumption, and that there areno allergens new to the food, no increased levels of natural toxicants, andno reduction of important nutrients. They also determine whether the foodhas been changed in any substantive way such that the food would need to bespecially labeled to reveal the nature of the change to consumers. Some examples of the information reviewed by FDA include:The name of the food and the crop from which it is derived; The uses of the food, including both human food and animal feed uses; The sources, identities, and functions of introduced genetic material andits stability in the plant; The purpose or intended technical effect of the modification and itsexpected effect on the composition or characteristic properties of the foodor feed; The identity and function of any new products encoded by the introducedgenetic material, including an estimate of its concentration; A comparison of the composition or characteristics of the bioengineered foodto that of food derived from the parental variety or other commonly consumedvarieties with special emphasis on important nutrients, anti-nutrients, andtoxicants that occur naturally in the food; Information on whether the genetic modification altered the potential forthe bioengineered food to induce an allergic response; and Other information relevant to the safety and nutritional assessment of thebioengineered food. If a plant developer used a gene from a source whose food is commonlyallergenic, FDA would presume that the modified food may be allergenic. Thedeveloper, however, is allowed the opportunity to demonstrate that such foodwould not cause allergic reactions in persons allergic to food from thesource. If FDA scientists have questions about the safety data, the company may, forexample, provide more detailed answers or conduct additional studies. Ourexperience has been that no bioengineered product has gone on the marketuntil FDA's questions about the safety of the product have been answered. LabelingSection 403 of the FD & C Act sets labeling requirements for all foods. Allfoods, whether derived using bioengineering or not, are subject to theselabeling requirements.Under section 403(a)(1) of the FD & C Act, a food is misbranded if itslabeling is false or misleading in any particular way. Section 201(n) of theFD & C Act provides additional guidance on how labeling may be misleading. Itstates that labeling is misleading if it fails to reveal all facts that are"material in light of such representations (made or suggested in thelabeling) or material with respect to consequences which may result from theuse of the article to which the labeling or advertising relates under theconditions of use prescribed in the labeling or advertising thereof or undersuch conditions of use as are customary or usual." Although the legislative history of section 201(n) contains littlediscussion of the word "material," there is precedent to guide the Agency inits decision regarding whether information on a food is in fact materialwithin the meaning of 201(n). Historically, the Agency has generally limitedthe scope of the materiality concept to information about the attributes ofthe food itself. FDA has required special labeling on the basis of it being"material" information in cases where the absence of such information may:(1) pose special health or environmental risks (e.g., warning statement oncertain protein diet products); (2) mislead the consumer in light of otherstatements made on the label (e.g., requirement for quantitative nutrientinformation when certain nutrient content claims are made about a product);or (3) in cases where a consumer may assume that a food, because of itssimilarity to another food, has nutritional, organoleptic (i.e., affectstaste, color, odor, or feel), or functional characteristics of the food itresembles when in fact it does not (e.g., reduced fat margarine may not besuitable for frying). FDA does not require labeling to indicate whether a food or food ingredientis a bioengineered product, just as it does not require labeling to indicatewhich conventional breeding technique was used in developing a food plant.Rather, any significant differences in the food itself have to be disclosedin labeling. If genetic modifications materially change the composition of afood product, these changes must be reflected in the food's labeling. Thiswould include its nutritional content (for example, more oleic acid, orgreater content of the amino acid lysine) or requirements for storage,preparation, or cooking, which might impact the food's safetycharacteristics or nutritional qualities. For example, one soybean varietywas modified to alter the levels of oleic acid in the beans. Because the oilfrom this soybean is significantly different when compared to conventionalsoybean oil, we advised the company to adopt a new name for that oil, a namethat reflects the intended change. If a bioengineered food were to contain an allergen not previously found inthat food, information about the presence of the allergen would be materialas to the potential consequences of consumption of the food. If FDAdetermined that labeling would be sufficient to enable the food to be safelymarketed, the Agency would require that the food be labeled to indicate thepresence of the allergen.FDA has received comments suggesting that foods developed through modernbiotechnology should bear a label informing consumers that the food wasproduced using bioengineering. We have given careful consideration to thesecomments. However, we do not have data or other information to form a basisfor concluding that the fact that a food (or any of its ingredients) wasproduced using bioengineering is material within the meaning of 201(n) and,therefore, constitutes information that must be disclosed as part of abioengineered product's labeling. Hence, we believe that we have neither ascientific nor a legal basis to require such labeling. We have developed,however, draft guidance for those who wish voluntarily to label either thepresence or absence of bioengineered food in food products. The Agricultural Biotechnology Working Group The interagency Agricultural Biotechnology Working Group, which includes theOffice of Science and Technology Policy (OSTP), FDA, EPA, USDA, and others,has addressed regulatory issues related to the potential for low,intermittent levels of materials from bioengineered food crops toinadvertently get into food or feed. In August 2002, OSTP published a Notice in the Federal Register (67 FR50578) which proposed coordinated actions by FDA, EPA, and USDA aimed atstrengthening controls over field trials to address the potential ofmaterial from field trials to inadvertently get into food or feed. As partof this OSTP initiative, on November 24, 2004, FDA issued a draft guidancedocument entitled, "Guidance for Industry: Recommendations for the EarlyFood Safety Evaluation of New Non-Pesticidal Proteins Produced by New PlantVarieties Intended for Food Use." This draft guidance outlines procedures toaddress the possible intermittent, low-level presence in food and feed ofnew non-pesticidal proteins from biotechnology-derived crops underdevelopment for food or feed use but that have not gone through FDA'spremarket consultation process. Under this guidance, FDA encouragesdevelopers to submit protein safety information once field testing reaches astage of development such that there could be concerns that newnon-pesticidal proteins produced in the field-tested plants might be foundin food or feed. FDA's focus would be on proteins new to such plants becauseFDA believes that any potential risk from the low level presence of suchmaterial in the food supply would be limited to the possibility that itwould contain or consist of a new protein that might be an allergen ortoxin. FDA would still expect developers to conduct a complete consultationwith FDA prior to marketing food or feed from the plant, consistent withcurrent practices. The comment period for the draft guidance closed onJanuary 24, 2005. FDA is reviewing the approximately 3000 comments receivedand expects to complete the final guidance by the end of the calendar year. The Agricultural Biotechnology Working Group is also working on the issue ofpharmaceutical crops. FDA has the authority and responsibility forregulating pharmaceuticals, including human biologics, whether they areproduced in traditional manufacturing facilities or from crops in the field.Regulations found in parts 210 & 211 of Title 21 of the Code of FederalRegulations outline practices that must be followed by pharmaceuticalmanufacturers as part of good manufacturing practice. These regulations aregeneral in nature and apply to all pharmaceutical manufacturingmethodologies, including plant-made pharmaceuticals. For crops in the field,however, there are particular issues to be addressed, for example, thedisposition of the residual crop left over after a pharmaceutical isextracted. The interagency working group is working to clarify authoritiesfor regulating genetically engineered crops ordinarily used to produce food(e.g., corn), whether they are intended for food, pharmaceutical, orindustrial use, and to make sure there are no gaps in protecting humanhealth and the environment. We are evaluating ways to help keeppharmaceutical and industrial compounds out of food when they are notsupposed to be there. We are looking at ways that would be science- andrisk-based, enforceable, complementary with the USDA-APHIS regulatoryscheme, and that would not pose too high a barrier to development of theseproducts. In September 2002, FDA and USDA jointly published the Draft Guidance forIndustry on the use of bioengineered plants or plant materials to producebiological products, including medical devices, new animal drugs, andveterinary biologics. This draft guidance, which contains sections on FDAoversight and sections on APHIS oversight, outlines the important scientificquestions and information that should be addressed to FDA by those who areusing bioengineered plants to produce medical or veterinary drug products.FDA and USDA are working to finalize this guidance document.Other Activities FDA has made a commitment to ensuring that consumers have access toinformation about new bioengineered food products in a timely fashion andhas made more information about these foods available on FDA's website. To ensure that FDA has the best scientific advice on issues related tobioengineered foods, we have added experts in this field to our foods andveterinary medicine advisory committees and created a Food BiotechnologySubcommittee of the Food Advisory Committee. In addition, NAS has formed a standing Committee on AgriculturalBiotechnology, Health and the Environment. FDA, EPA and USDA requested thatthe committee assess the potential for unintended effects of geneticallyengineered foods and how to evaluate their impact on human health. Thecommittee's report, "Safety of Genetically Engineered Foods: Approaches toAssessing Unintended Health Effects," was published in July 2004. Accordingto the committee, all evidence evaluated to date indicates that unexpectedand unintended compositional changes arise with all forms of geneticmodification, including conventional methods and genetic engineeringtechniques. The committee noted that a "policy to assess products basedexclusively on their method of breeding is scientifically unjustified." Thecommittee recommended that compositional changes that result from any methodof genetic modification in food, including genetic engineering, undergo anappropriate safety assessment. The committee presented an approach toscientifically assess whether unintended effects that result from thegenetic modification could lead to adverse health concerns. The approachsuggested by the committee is generally consistent with FDA's approach.FDA provided international leadership in the work of the Codex Ad HocIntergovernmental Task Force on Foods Derived from Biotechnology, a taskforce established for a four-year time span by the Codex AlimentariusCommission (Codex). The work of this task force was especially importantbecause it developed internationally accepted principles and guidelines forthe evaluation of the safety of bioengineered foods. Those principles andguidelines were adopted by Codex in 2003, at the conclusion of the life ofthe task force. These principles and guidelines are the internationalstandards for ensuring the safety of genetically engineered foods, and theyare consistent with FDA's approach. Codex recently re-established the taskforce for another four-year span. It will have its first meeting this comingSeptember, when it will decide on new work.FDA also is actively participating as a member of the Organization forEconomic Cooperation and Development's Task Force for the Safety of NovelFoods and Feeds. This task force is in the process of writingscientific/technical consensus documents aimed at compiling currentinformation that is important in food and feed safety assessment. Theseconsensus documents serve as references to Codex and regulatory bodies.Mr. Chairman, FDA, in cooperation with EPA and USDA, will continue itsoversight of new and emerging food biotechnology products and will bevigilant in ensuring the safety and integrity of the food supply. I thankyou again for the opportunity to address these issues. I am happy to answerany questions you might have. ---------To be d from the News Update from The Campaign mailing list simply below http://www.thecampaign.org/cgi-bin/sment/s.cgi?r=1 & l=2 & e=namaska7=:aol.comAOL USERS:One-Click Un Link HereNews Update From The Campaign ----------------Dear News Update Subscribers,WHO REPORT ON BIOTECH FOODSThe World Health Organization (WHO) released a report on Thursday that callsinto question the current safety oversight of genetically engineered foods.The report titled "Modern food biotechnology, human health and development:an evidence-based study" calls for case-by-case risk assessment of each newbiotech food on its effects on human health. It also emphasizes theimportance of long-term monitoring to catch any possible adverse effects.Similar to other safety review studies on genetically engineered foods, thisWHO report raises many concerns over the current safety testing methods, butdoes not suggest that the biotech foods now being sold may be causing healthproblems. (Perhaps the authors of these reports don't want to alarm consumers by suggesting there was inadequate review of existing crops?)While The Campaign is glad that the World Health Organization is raising concerns over the current testing and monitoring methods, we don't agree that the biotech crops now being consumed should be assumed to be safe. WHO states that thecurrent crops have had pre-market risk assessments. But these risk assessmentshave been done by the biotech companies themselves. Where are the safety studies that prove the current biotech crops are indeed safe? They don't exist.There may be low level allergic reactions taking place in tens of thousandsof people who are currently eating genetically engineered foods. But withoutlabeling, it is extremely difficult for the Centers For Disease Control todiscover patterns of low level allergic reactions.NAS REPORT RAISED THE SAME CONCERNSLast July, the National Academy of Sciences (NAS) issued a report titled"Safety of Genetically Engineered Foods: Approaches to Assessing UnintendedHealth Effects."The NAS report had similar findings and concerns as the WHO report. The NASreport stated: "There is a need, in the committee's judgment, for a broadresearch and technology development agenda to improve methods forpredicting, identifying, and assessing unintended health effects from thegenetic modification of food." FDA SPINS THE DATA TO CONGRESSIn spite of numerous reports criticizing the oversight of geneticallyengineered foods, the U.S. Food and Drug Administration refuses to acceptthere are problems with the current regulatory scheme.Last week the Director of the FDA's Center for Food Safety and AppliedNutrition, Robert E. Brackett, Ph.D., testified before the U.S. SenateCommittee on Agriculture, Nutrition and Forestry about the FDA's regulatoryprogram for genetically engineered foods.Rather than acknowledging the findings of the NAS report and others aboutthe need for significant improvements in the oversight of geneticallyengineered foods, Brackett assured the Senate committee that everything wasworking great with the current system.It was particularly disturbing that Brackett said the NAS report found thatgenetically engineered foods "are as safe as their conventionalcounterparts." Actually the NAS report stated that the likelihood of"unintended genetic effects" were significantly higher in geneticallyengineered foods. They even had a chart showing this on page 64 of the NASreport. Next month The Campaign will put together an ACTION ALERT to the SenateCommittee on Agriculture, Nutrition and Forestry pointing out how DirectorBrackett misrepresented the facts contained in the NAS report when hetestified before them. And we will point out that the new WHO report raisedthe same concerns as the NAS report about the need for better riskassessment and safety monitoring.THE FDA CONTINUES TO REFUSE TO ACCEPT THE FACTSIt was disappointing that FDA administrators never listened to concerns oftheir own scientists when they set up the original regulations forgenetically engineered foods in 1992. At that point in time, FDA scientistsrecommended that each crop should be reviewed on a case-by-case basis. Butinstead, the administrators ignored the concerns of their own scientists andstated that genetically engineered foods are "substantially equivalent" toconventional crops and need no special testing or labeling (unless the cropscontain a known allergen or have a significantly altered nutrient content). And now that several of the most respected scientific bodies in the worldhave called for better pre-market testing and post-market monitoring, theFDA continues to argue that the current system is working fine and does notneed to be changed. READ THE REPORTS YOURSELFPosted below is an article from the Food Navigator - USA web site titled"Health effects of GM foods need further study, WHO says."If you want to read the actual World Health Organization report titled"Modern food biotechnology, human health and development: an evidence-basedstudy" visit the following web page:http://www.thecampaign.org/who062305.pdfIf you want to read the National Academy of Sciences report titled "Safetyof Genetically Engineered Foods: Approaches to Assessing Unintended HealthEffects" visit the following web page:http://www.thecampaign.org/nas0704.htmIf you want to read the testimony of the Director of the FDA's Center forFood Safety and Applied Nutrition, Robert E. Brackett, Ph.D., before theU.S. Senate Committee on Agriculture, Nutrition and Forestry about theregulation of genetically engineered foods, it is posted below. Or you mayread it at the FDA's web site at:http://www.fda.gov/ola/2005/bioengineered0614.htmlContrary to what Director Brackett stated to Congress, the regulation ofgenetically engineered foods in the United States is entirely inadequate. Atthe very least, we need all genetically engineered foods to be labeled andsafety tested. Craig WintersExecutive DirectorThe Campaign to Label Genetically Engineered FoodsThe CampaignPO Box 55699Seattle, WA 98155Tel: 425-771-4049E-mail: labelWeb Site: http://www.thecampaign.org Mission Statement: "To create a national grassroots consumer campaign forthe purpose of lobbying Congress and the President to pass legislation thatwill require the labeling of genetically engineered foods in the UnitedStates."*************************************************************** Health effects of GM foods need further study, WHO saysFood Navigator - USA6/24/2005http://www.foodnavigator-usa.com/news/printNewsBis.asp?id=60866A call by the World Health Organisation for further safety assessments onusing genetically modified (GM) foods should give governments pause forthought before giving their approval for their wider use of the technology.In a report issued yesterday, the UN body finds that GM foods can increasecrop yield, food quality and the diversity of foods that can be grown in agiven area but warns against rushing to introduce novel types of genes intothe food chain.The WHO report further complicates the international dispute over GM foodswhich has left multinational companies with having to deal with differentsets of regulations depending on the countries in which they operate.The sale of GM foods has put nations at loggerheads with each other. The EUand Japan have enacted labelling and traceability requirements for GM foodproducts, while the US and Canada believe the technology is safe and thatsuch standards are not necessary. The US, Canada and Argentina have filedcases with the World Trade Organisation against the EU's requirements.WHO calls for a case-by-case risk assessment of each new GM food on itseffects on human health, on the food chain and on the environment ratherthan a general endorsement by governments on the use of the technology tocreate new types of crops or animals.WHO notes that pre-market risk assessments have been performed on all GMfood products that are currently marketed. To date, the consumption of GMfoods has not caused any known negative health effects. Currently,evaluations of GM primarily focus on the ecological and agriculturalramifications and on possible health effects."However, some of the genes used to manufacture GM foods have not been inthe food chain before and the introduction of new genes may cause changes inthe existing genetic make-up of the crop," WHO stated in its assessment."Therefore, the potential human health effects of new GM foods should alwaysbe assessed before they are grown and marketed, and long-term monitoringmust be carried out to catch any possible adverse effects early."The organisation recommends such evaluations should be widened to includesocial, cultural and ethical considerations, to help prevent what WHO callsa "genetic divide" between groups of countries which do and do not allow thegrowth, cultivation and marketing of GM products."Each country has different prevailing social and economic conditions, andthe people have different histories of what they eat and what food means intheir society," WHO stated. "All of these factors can affect how GM foodswill be regarded, and taking proper account of these concerns will affectthe long-term acceptance or rejection of GM foods and their possible healthbenefits and potential risks."There are now 15 international legally-binding instruments and nonbindingcodes of practice addressing aspects of GM organisms. Many developedcountries have established specific pre-market regulatory systems requiringthe rigorous case-by-case risk assessment of GM foods prior to theirrelease. Many developing countries lack the capacity to implement a similarsystem, WHO stated.In 2004 about 81m hectares of land was being used to grow GM crops by sevenmillion farmers in 18 countries, mainly the US, Argentina, Canada, Brazil,China, Paraguay and South Africa.The first major GM food was introduced on the market in the mid-1990s andpaved the way for the growing of strains of maize, soybeans, rapeseed andcotton. GM varieties of papaya, potato, rice, squash, sugar beet and tomatohave been released in certain countries. WHO estimates that at the end of2004 GM crops covered about four per cent of the total global arable land.Most of the GMOs commercialised so far in developing countries have beenacquired from developed countries and focus on a limited number of traits,mainly herbicide tolerance and insect pest resistance, and crops such ascotton, soybean and maize. Research is also underway on GM seafood andanimals.Many food-processing aids, such as enzymes, produced through the use of GMmicroorganisms have been on the market for over a decade and are used in awide variety of processed foods. No live GM food microorganisms have beenintroduced onto the market yet, WHO stated.Current EU requires that all food be tracked and labelled if it contains 0.9per cent or more traceable GM content, along with derivatives such as pasteand ketchup from a GM tomato. Products derived from GM processing aids, suchas GM enzymes or yeast, are not affected. Inciting strong criticism fromenvironmental groups, this year a panel of scientists at the European FoodSafety Authority (EFSA) cleared a variety of genetic maize known as 1507 forcultivation. Maize 1507 is made jointly by Pioneer Hi-Bred International, asubsidiary of DuPont, and Mycogen seeds, a Dow AgroSciences unit.Biotechnology, in its technical sense, refers to plant and animal farmingtechniques that alter living organisms to make or modify food products.There are many possible products from transgenic plants, plant parts, andprocessed foodstuffs, including highly refined substances such as vegetableoil containing little or no detectable transgene-derived protein or DNA.Under the Cartagena Protocol on Biosafety, governments will signal whetheror not they are willing to accept imports of agricultural commodities thatinclude GMOs by communicating their decision via an Internet-based BiosafetyClearing House.*************************************************************** Statement of Robert E. Brackett, Ph.D. Director, Center for Food Safety and Applied NutritionbeforeCommittee on Agriculture, Nutrition and ForestryUnited States Senate June 14, 2005 Introduction Mr. Chairman and Members of the Committee, I am Robert Brackett, Director,Center for Food Safety and Applied Nutrition at the Food and DrugAdministration (FDA or the Agency). Thank you for the opportunity to testifytoday on FDA's regulatory program for foods derived from bioengineeredplants, also known as genetically engineered, or bioengineered, foods. Background Within FDA, the Center for Food Safety and Applied Nutrition (CFSAN)oversees bioengineered plant-derived food and ingredients intended for humanconsumption. Our Center for Veterinary Medicine (CVM) oversees bioengineeredplant-derived products used as animal feed or as ingredients in animal feed,as well as bioengineered products used to improve the health or productivityof animals. My testimony this morning focuses on bioengineered plant-derivedfoods. Let me also clarify that in the Federal Food, Drug, and Cosmetic(FD & C) Act, food is defined as food for man or other animals. So, when Italk about food, it also encompasses animal feed unless stated otherwise. We believe it is very important for the public to understand how FDA isregulating the bioengineered foods being introduced into the marketplace andto have confidence in that process. Therefore, I appreciate this opportunityto describe our policies and procedures.First, let me state that FDA is confident that the bioengineered foods onthe United States market today are as safe as their conventionalcounterparts. This conclusion has been echoed in recent reports by theNational Academy of Sciences (NAS) and the Government Accountability Office,and most recently in a 2004 report from NAS's National Research Council andInstitute of Medicine entitled, "Safety of Genetically Engineered Foods:Approaches to Assessing Unintended Health Effects." Over the last ten years,FDA has reviewed the data on more than 60 bioengineered food products,ranging from herbicide resistant soybeans to a modified canola oil. To date,the evidence shows that these foods are as safe as their conventionalcounterparts. In a 1992 policy statement on bioengineered foods, FDA announced that theAgency was "not aware of any information showing that foods derived by thesenew methods differ from other foods in any meaningful or material way, orthat, as a class, foods developed by the new techniques present anydifferent or greater safety concern than foods developed by traditionalplant breeding." This 1992 statement and its scientific underpinnings stillreflect FDA's thinking about bioengineered foods. Crossbreeding, Hybridization, and BioengineeringThe selection and genetic improvement of plants for agricultural use hasbeen going on for thousands of years, although plant breeding as a scienceonly began in the late 1800s. Typically, plant breeding has involvedcrossbreeding and hybridization, in which two related plants arecross-fertilized, and the resulting offspring have characteristics of bothparent plants. In the breeding process, however, many undesirable traitsoften can appear in addition to the desirable ones. Some of thoseundesirable traits can be eliminated through additional breeding, which istime-consuming. Breeders can then further select and reproduce the offspringthat have the desired traits. Many of the foods that are already common inour diet are obtained from plant varieties that were developed usingconventional genetic techniques of breeding and selection. Hybrid corn,nectarines (which could be considered genetically altered peaches), andtangelos (which are a genetic hybrid of a tangerine and grapefruit) are allexamples of such breeding and selection. Today, by inserting one or more genes into a plant, scientists are able toproduce a plant with new, advantageous characteristics. The new genesplicing techniques are being used to achieve many of the same goals andimprovements that plant breeders historically have sought throughconventional methods. Today's techniques can be used with greater precisionand allow for more complete characterization and, therefore, greaterpredictability, of the qualities of the new variety. They give scientiststhe ability to isolate genes and introduce new traits into foods withoutsimultaneously introducing undesirable traits. This is an importantimprovement over traditional breeding. Any genetic modification technique,including both traditional methods and bioengineering, could change thecomposition of a food in a manner relevant to food safety. But because ofthe increased precision offered by the bioengineered methods, the risk ofinadvertently introducing detrimental traits is actually likely to belessened. Bioengineering does expand the range of new proteins and othersubstances that can be introduced into plants. However, the agencies havewell-established procedures for determining the safety of such newsubstances. FDA has found no evidence to indicate that deoxyribonucleic acid (DNA)inserted into plants using bioengineering presents food safety problems. Thesmall amounts of the newly expressed proteins are generally unlikely tochange the safety profile of the plant. If safety concerns should arise,however, they would most likely fall into one of three broad categories:allergens, toxins, or anti-nutrients. FDA has extensive experience inevaluating the safety of such substances in food.As to potential allergens, foods normally contain many thousands ofdifferent proteins. While the majority of proteins do not cause allergicreactions, virtually all known human allergens are proteins. Since geneticengineering can introduce a new protein into a food plant, it is possiblethat this technique could introduce a previously unknown allergen into thefood supply or could introduce a known allergen into a "new" food. FDA'sguidelines help developers to identify this issue and address any concernprior to marketing. A second possible problem is the introduction of toxins into the food crop.It is possible that a new protein could cause toxicity. A third possibleissue is the introduction of anti-nutrients, such as molecules like phyticacid that binds essential dietary minerals such as phosphorus. Breeding, whether bioengineering or otherwise, can cause unintended changesin the composition of the food. For example, it might result in a reductionof Vitamin C or an increase in the concentration of a naturally occurringtoxin in the food. Developers of bioengineered foods analyze the compositionof the foods from their new crop varieties to ensure that they do not marketfoods whose composition differs from conventionally-derived counterparts. It is important to note that the kinds of food safety testing typicallyconducted by developers of a bioengineered food crop to ensure that theirfoods meet all applicable requirements of the FD & C Act address thesepotential concerns. In the event that something unexpected does occur, thistesting provides a way to detect such changes at the developmental stage anddefer marketing until any concern is resolved. Legal and Regulatory Background The overall Federal regulatory structure for biotechnology products, knownas the Coordinated Framework, was adopted by Federal agencies in 1986 (51 FR23302, June 26, 1986). Under the Coordinated Framework, FDA regulatesbioengineered plant-derived food in conjunction with the United StatesDepartment of Agriculture (USDA) and the Environmental Protection Agency(EPA). FDA has authority under the FD & C Act to ensure the safety of alldomestic and imported foods for man or other animals in the U.S. market. Theexceptions to this are meat, poultry, and processed egg products, which areregulated by USDA. The safety of animal drug residues in meat and poultry,however, is regulated by FDA's CVM. Pesticides, including thosebioengineered into a food crop, are regulated primarily by EPA, whichreviews safety and sets tolerances (or establishes exemption from tolerance)for pesticides. FDA enforces the pesticide tolerances set by EPA. USDA'sAnimal & Plant Health Inspection Service (APHIS) oversees the agriculturaland environmental safety of planting and field testing of bioengineeredplants. Bioengineered foods and food ingredients must adhere to the same standardsof safety under the FD & C Act that apply to their conventionally bredcounterparts. This means that these products must be as safe as thetraditional foods on the market. FDA has broad authority to initiateregulatory action if a product fails to meet the requirements of the FD & CAct. FDA relies primarily on two sections of the FD & C Act to ensure the safety offoods and food ingredients that are produced using biotechnology:The adulteration provisions of section 402(a)(1). Under this postmarketauthority, FDA has the power to remove a food from the market (or sanctionthose marketing the food) if the food poses a risk to public health. It isimportant to note that the FD & C Act places a legal duty on developers toensure that the foods they market to consumers are safe and comply with alllegal requirements. The food additive provisions in section 409. Under this section, a substancethat is intentionally added to food is a food additive, unless the substanceis generally recognized as safe (GRAS) or is otherwise exempt (e.g., apesticide, the safety of which is overseen by EPA). Unapproved foodadditives are subject to the adulteration provisions in 402 (a)(2)© of theFD & C Act. The FD & C Act requires premarket approval of any food additive, regardless ofthe technique used to add it to food. Thus, substances introduced into foodare either: (1) new food additives that require premarket approval by FDA;or (2) GRAS, and are therefore exempt from the requirement for premarketreview by FDA. Generally, foods such as fruits, vegetables, and grains arenot subject to premarket approval under the FD & C Act because they have beensafely consumed over many years. Other than the food additive system, thereare no FDA premarket approval requirements for foods generally. In 1992, recognizing that bioengineered products were on the horizon, FDApublished a policy explaining how existing legal requirements would apply toproducts developed using the tools of biotechnology (57 FR 22984; May 29,1992; "Statement of Policy: Foods Derived from New Plant Varieties"). The1992 policy was designed to answer questions about these products and toassist developers prior to marketing to meet their legal duty to providesafe and wholesome foods to consumers. The basic principle of the 1992policy is that the traits and characteristics of the foods should be thefocus of safety assessment for all new varieties of food crops, no matterwhich techniques are used to develop them. Under FDA policy, a substance that would be a food additive if it were addedduring traditional food manufacturing is also treated as a food additive ifit is introduced into food through bioengineering of a food crop. Ourauthority under section 409 permits us to require premarket approval of anyfood additive and, thus, to require premarket approval of any substanceintentionally introduced via bioengineering that is not GRAS.Examples ofsubstances intentionally introduced into food that would bereviewed as food additives include those that have unusual chemicalfunctions, have unknown toxicity, or would be new major dietary componentsof the food. For example, a novel sweetener bioengineered into food wouldlikely require premarket approval. In our experience with bioengineered foodto date, however, we have reviewed only one substance under the foodadditive provisions, an enzyme produced by an antibiotic resistance gene(kanamycin), and we granted approval as a food additive. In general,substances intentionally added to or modified in food via biotechnology todate have been proteins and fats that are, with respect to safety, similarto other proteins and fats that are commonly and safely consumed in the dietand, thus, are presumptively GRAS. Therefore, they have not needed to gothrough the food additive approval process.In 1994, following the 1992 policy, FDA conducted a comprehensive scientificreview for the first bioengineered product planned for introduction into themarket. FDA reviewed Calgene's data on the Flavr SavrT tomato and the use ofthe kanamycin resistance marker gene. Calgene submitted food additivepetitions for the enzyme product of the marker gene for use in food andfeed. We subsequently approved the petitions. FDA also held a public meetingof our Food Advisory Committee to examine applicability of the 1992 policyto products such as the Flavr SavrT tomato. The Advisory Committee membersagreed with FDA that the scientific approach presented in the 1992 policywas sound and that the questions regarding the Flavr SavrT had beenaddressed. The Advisory Committee members also suggested that we provide anexpedited decision process for the marketing of bioengineered foods that donot raise substantive scientific issues.In response, FDA established a voluntary consultative process to helpcompanies comply with the FD & C Act's requirements for the bioengineeredfoods that they intend to market. The results of our consultation are publicinformation and are available on our website. Since the consultation processwas created, companies have used the consultative process more than 60 timesas they sought to introduce genetically altered plants representing morethan 16 different crops into the U.S. market. We are not aware of anybioengineered plant-derived food intended for commercialization that issubject to FDA's jurisdiction that has not been evaluated by FDA through thecurrent consultation process.Typically, the consultation begins early in the product development stage,before it is ready for market. Company scientists and other officials meetwith FDA scientists to describe the product they are developing. Inresponse, the Agency advises the company on what tests would be appropriatefor the company to assess the safety of the new food. After the studies are completed, the data and information on the safety andnutritional assessment are provided to FDA for review. The Agency evaluatesthe information for all of the known hazards and also for potentialunintended effects on plant composition and nutritional properties, sinceplants may undergo changes other than those intended by the breeders. Forexample, FDA scientists evaluate data and information to assure that thenewly expressed compounds are safe for food consumption, and that there areno allergens new to the food, no increased levels of natural toxicants, andno reduction of important nutrients. They also determine whether the foodhas been changed in any substantive way such that the food would need to bespecially labeled to reveal the nature of the change to consumers. Some examples of the information reviewed by FDA include:The name of the food and the crop from which it is derived; The uses of the food, including both human food and animal feed uses; The sources, identities, and functions of introduced genetic material andits stability in the plant; The purpose or intended technical effect of the modification and itsexpected effect on the composition or characteristic properties of the foodor feed; The identity and function of any new products encoded by the introducedgenetic material, including an estimate of its concentration; A comparison of the composition or characteristics of the bioengineered foodto that of food derived from the parental variety or other commonly consumedvarieties with special emphasis on important nutrients, anti-nutrients, andtoxicants that occur naturally in the food; Information on whether the genetic modification altered the potential forthe bioengineered food to induce an allergic response; and Other information relevant to the safety and nutritional assessment of thebioengineered food. If a plant developer used a gene from a source whose food is commonlyallergenic, FDA would presume that the modified food may be allergenic. Thedeveloper, however, is allowed the opportunity to demonstrate that such foodwould not cause allergic reactions in persons allergic to food from thesource. If FDA scientists have questions about the safety data, the company may, forexample, provide more detailed answers or conduct additional studies. Ourexperience has been that no bioengineered product has gone on the marketuntil FDA's questions about the safety of the product have been answered. LabelingSection 403 of the FD & C Act sets labeling requirements for all foods. Allfoods, whether derived using bioengineering or not, are subject to theselabeling requirements.Under section 403(a)(1) of the FD & C Act, a food is misbranded if itslabeling is false or misleading in any particular way. Section 201(n) of theFD & C Act provides additional guidance on how labeling may be misleading. Itstates that labeling is misleading if it fails to reveal all facts that are"material in light of such representations (made or suggested in thelabeling) or material with respect to consequences which may result from theuse of the article to which the labeling or advertising relates under theconditions of use prescribed in the labeling or advertising thereof or undersuch conditions of use as are customary or usual." Although the legislative history of section 201(n) contains littlediscussion of the word "material," there is precedent to guide the Agency inits decision regarding whether information on a food is in fact materialwithin the meaning of 201(n). Historically, the Agency has generally limitedthe scope of the materiality concept to information about the attributes ofthe food itself. FDA has required special labeling on the basis of it being"material" information in cases where the absence of such information may:(1) pose special health or environmental risks (e.g., warning statement oncertain protein diet products); (2) mislead the consumer in light of otherstatements made on the label (e.g., requirement for quantitative nutrientinformation when certain nutrient content claims are made about a product);or (3) in cases where a consumer may assume that a food, because of itssimilarity to another food, has nutritional, organoleptic (i.e., affectstaste, color, odor, or feel), or functional characteristics of the food itresembles when in fact it does not (e.g., reduced fat margarine may not besuitable for frying). FDA does not require labeling to indicate whether a food or food ingredientis a bioengineered product, just as it does not require labeling to indicatewhich conventional breeding technique was used in developing a food plant.Rather, any significant differences in the food itself have to be disclosedin labeling. If genetic modifications materially change the composition of afood product, these changes must be reflected in the food's labeling. Thiswould include its nutritional content (for example, more oleic acid, orgreater content of the amino acid lysine) or requirements for storage,preparation, or cooking, which might impact the food's safetycharacteristics or nutritional qualities. For example, one soybean varietywas modified to alter the levels of oleic acid in the beans. Because the oilfrom this soybean is significantly different when compared to conventionalsoybean oil, we advised the company to adopt a new name for that oil, a namethat reflects the intended change. If a bioengineered food were to contain an allergen not previously found inthat food, information about the presence of the allergen would be materialas to the potential consequences of consumption of the food. If FDAdetermined that labeling would be sufficient to enable the food to be safelymarketed, the Agency would require that the food be labeled to indicate thepresence of the allergen.FDA has received comments suggesting that foods developed through modernbiotechnology should bear a label informing consumers that the food wasproduced using bioengineering. We have given careful consideration to thesecomments. However, we do not have data or other information to form a basisfor concluding that the fact that a food (or any of its ingredients) wasproduced using bioengineering is material within the meaning of 201(n) and,therefore, constitutes information that must be disclosed as part of abioengineered product's labeling. Hence, we believe that we have neither ascientific nor a legal basis to require such labeling. We have developed,however, draft guidance for those who wish voluntarily to label either thepresence or absence of bioengineered food in food products. The Agricultural Biotechnology Working Group The interagency Agricultural Biotechnology Working Group, which includes theOffice of Science and Technology Policy (OSTP), FDA, EPA, USDA, and others,has addressed regulatory issues related to the potential for low,intermittent levels of materials from bioengineered food crops toinadvertently get into food or feed. In August 2002, OSTP published a Notice in the Federal Register (67 FR50578) which proposed coordinated actions by FDA, EPA, and USDA aimed atstrengthening controls over field trials to address the potential ofmaterial from field trials to inadvertently get into food or feed. As partof this OSTP initiative, on November 24, 2004, FDA issued a draft guidancedocument entitled, "Guidance for Industry: Recommendations for the EarlyFood Safety Evaluation of New Non-Pesticidal Proteins Produced by New PlantVarieties Intended for Food Use." This draft guidance outlines procedures toaddress the possible intermittent, low-level presence in food and feed ofnew non-pesticidal proteins from biotechnology-derived crops underdevelopment for food or feed use but that have not gone through FDA'spremarket consultation process. Under this guidance, FDA encouragesdevelopers to submit protein safety information once field testing reaches astage of development such that there could be concerns that newnon-pesticidal proteins produced in the field-tested plants might be foundin food or feed. FDA's focus would be on proteins new to such plants becauseFDA believes that any potential risk from the low level presence of suchmaterial in the food supply would be limited to the possibility that itwould contain or consist of a new protein that might be an allergen ortoxin. FDA would still expect developers to conduct a complete consultationwith FDA prior to marketing food or feed from the plant, consistent withcurrent practices. The comment period for the draft guidance closed onJanuary 24, 2005. FDA is reviewing the approximately 3000 comments receivedand expects to complete the final guidance by the end of the calendar year. The Agricultural Biotechnology Working Group is also working on the issue ofpharmaceutical crops. FDA has the authority and responsibility forregulating pharmaceuticals, including human biologics, whether they areproduced in traditional manufacturing facilities or from crops in the field.Regulations found in parts 210 & 211 of Title 21 of the Code of FederalRegulations outline practices that must be followed by pharmaceuticalmanufacturers as part of good manufacturing practice. These regulations aregeneral in nature and apply to all pharmaceutical manufacturingmethodologies, including plant-made pharmaceuticals. For crops in the field,however, there are particular issues to be addressed, for example, thedisposition of the residual crop left over after a pharmaceutical isextracted. The interagency working group is working to clarify authoritiesfor regulating genetically engineered crops ordinarily used to produce food(e.g., corn), whether they are intended for food, pharmaceutical, orindustrial use, and to make sure there are no gaps in protecting humanhealth and the environment. We are evaluating ways to help keeppharmaceutical and industrial compounds out of food when they are notsupposed to be there. We are looking at ways that would be science- andrisk-based, enforceable, complementary with the USDA-APHIS regulatoryscheme, and that would not pose too high a barrier to development of theseproducts. In September 2002, FDA and USDA jointly published the Draft Guidance forIndustry on the use of bioengineered plants or plant materials to producebiological products, including medical devices, new animal drugs, andveterinary biologics. This draft guidance, which contains sections on FDAoversight and sections on APHIS oversight, outlines the important scientificquestions and information that should be addressed to FDA by those who areusing bioengineered plants to produce medical or veterinary drug products.FDA and USDA are working to finalize this guidance document.Other Activities FDA has made a commitment to ensuring that consumers have access toinformation about new bioengineered food products in a timely fashion andhas made more information about these foods available on FDA's website. To ensure that FDA has the best scientific advice on issues related tobioengineered foods, we have added experts in this field to our foods andveterinary medicine advisory committees and created a Food BiotechnologySubcommittee of the Food Advisory Committee. In addition, NAS has formed a standing Committee on AgriculturalBiotechnology, Health and the Environment. FDA, EPA and USDA requested thatthe committee assess the potential for unintended effects of geneticallyengineered foods and how to evaluate their impact on human health. Thecommittee's report, "Safety of Genetically Engineered Foods: Approaches toAssessing Unintended Health Effects," was published in July 2004. Accordingto the committee, all evidence evaluated to date indicates that unexpectedand unintended compositional changes arise with all forms of geneticmodification, including conventional methods and genetic engineeringtechniques. The committee noted that a "policy to assess products basedexclusively on their method of breeding is scientifically unjustified." Thecommittee recommended that compositional changes that result from any methodof genetic modification in food, including genetic engineering, undergo anappropriate safety assessment. The committee presented an approach toscientifically assess whether unintended effects that result from thegenetic modification could lead to adverse health concerns. The approachsuggested by the committee is generally consistent with FDA's approach.FDA provided international leadership in the work of the Codex Ad HocIntergovernmental Task Force on Foods Derived from Biotechnology, a taskforce established for a four-year time span by the Codex AlimentariusCommission (Codex). The work of this task force was especially importantbecause it developed internationally accepted principles and guidelines forthe evaluation of the safety of bioengineered foods. Those principles andguidelines were adopted by Codex in 2003, at the conclusion of the life ofthe task force. These principles and guidelines are the internationalstandards for ensuring the safety of genetically engineered foods, and theyare consistent with FDA's approach. Codex recently re-established the taskforce for another four-year span. It will have its first meeting this comingSeptember, when it will decide on new work.FDA also is actively participating as a member of the Organization forEconomic Cooperation and Development's Task Force for the Safety of NovelFoods and Feeds. This task force is in the process of writingscientific/technical consensus documents aimed at compiling currentinformation that is important in food and feed safety assessment. Theseconsensus documents serve as references to Codex and regulatory bodies.Mr. Chairman, FDA, in cooperation with EPA and USDA, will continue itsoversight of new and emerging food biotechnology products and will bevigilant in ensuring the safety and integrity of the food supply. I thankyou again for the opportunity to address these issues. I am happy to answerany questions you might have. ---------To be d from the News Update from The Campaign mailing list simply below http://www.thecampaign.org/cgi-bin/sment/s.cgi?r=1 & l=2 & e=namaska7=:aol.com

 

 

 

 

News Update From The Campaign

----------------

 

Dear News Update Subscribers,

 

WHO REPORT ON BIOTECH FOODS

 

The World Health Organization (WHO) released a report on Thursday that calls

into question the current safety oversight of genetically engineered foods.

 

The report titled " Modern food biotechnology, human health and development:

an evidence-based study " calls for case-by-case risk assessment of each new

biotech food on its effects on human health. It also emphasizes the

importance of long-term monitoring to catch any possible adverse effects.

 

Similar to other safety review studies on genetically engineered foods, this

WHO report raises many concerns over the current safety testing methods, but

does not suggest that the biotech foods now being sold may be causing health

problems. (Perhaps the authors of these reports don't want to alarm consumers

by suggesting there was inadequate review of existing crops?)

 

While The Campaign is glad that the World Health Organization is raising

concerns

over the current testing and monitoring methods, we don't agree that the biotech

crops now being consumed should be assumed to be safe. WHO states that the

current crops have had pre-market risk assessments. But these risk assessments

have been done by the biotech companies themselves. Where are the safety

studies that prove the current biotech crops are indeed safe? They don't exist.

 

There may be low level allergic reactions taking place in tens of thousands

of people who are currently eating genetically engineered foods. But without

labeling, it is extremely difficult for the Centers For Disease Control to

discover patterns of low level allergic reactions.

 

NAS REPORT RAISED THE SAME CONCERNS

 

Last July, the National Academy of Sciences (NAS) issued a report titled

" Safety of Genetically Engineered Foods: Approaches to Assessing Unintended

Health Effects. "

 

The NAS report had similar findings and concerns as the WHO report. The NAS

report stated: " There is a need, in the committee's judgment, for a broad

research and technology development agenda to improve methods for

predicting, identifying, and assessing unintended health effects from the

genetic modification of food. "

 

FDA SPINS THE DATA TO CONGRESS

 

In spite of numerous reports criticizing the oversight of genetically

engineered foods, the U.S. Food and Drug Administration refuses to accept

there are problems with the current regulatory scheme.

 

Last week the Director of the FDA's Center for Food Safety and Applied

Nutrition, Robert E. Brackett, Ph.D., testified before the U.S. Senate

Committee on Agriculture, Nutrition and Forestry about the FDA's regulatory

program for genetically engineered foods.

 

Rather than acknowledging the findings of the NAS report and others about

the need for significant improvements in the oversight of genetically

engineered foods, Brackett assured the Senate committee that everything was

working great with the current system.

 

It was particularly disturbing that Brackett said the NAS report found that

genetically engineered foods " are as safe as their conventional

counterparts. " Actually the NAS report stated that the likelihood of

" unintended genetic effects " were significantly higher in genetically

engineered foods. They even had a chart showing this on page 64 of the NAS

report.

 

Next month The Campaign will put together an ACTION ALERT to the Senate

Committee on Agriculture, Nutrition and Forestry pointing out how Director

Brackett misrepresented the facts contained in the NAS report when he

testified before them. And we will point out that the new WHO report raised

the same concerns as the NAS report about the need for better risk

assessment and safety monitoring.

 

THE FDA CONTINUES TO REFUSE TO ACCEPT THE FACTS

 

It was disappointing that FDA administrators never listened to concerns of

their own scientists when they set up the original regulations for

genetically engineered foods in 1992. At that point in time, FDA scientists

recommended that each crop should be reviewed on a case-by-case basis. But

instead, the administrators ignored the concerns of their own scientists and

stated that genetically engineered foods are " substantially equivalent " to

conventional crops and need no special testing or labeling (unless the crops

contain a known allergen or have a significantly altered nutrient content).

 

And now that several of the most respected scientific bodies in the world

have called for better pre-market testing and post-market monitoring, the

FDA continues to argue that the current system is working fine and does not

need to be changed.

 

READ THE REPORTS YOURSELF

 

Posted below is an article from the Food Navigator - USA web site titled

" Health effects of GM foods need further study, WHO says. "

 

If you want to read the actual World Health Organization report titled

" Modern food biotechnology, human health and development: an evidence-based

study " visit the following web page:

http://www.thecampaign.org/who062305.pdf

 

If you want to read the National Academy of Sciences report titled " Safety

of Genetically Engineered Foods: Approaches to Assessing Unintended Health

Effects " visit the following web page:

http://www.thecampaign.org/nas0704.htm

 

If you want to read the testimony of the Director of the FDA's Center for

Food Safety and Applied Nutrition, Robert E. Brackett, Ph.D., before the

U.S. Senate Committee on Agriculture, Nutrition and Forestry about the

regulation of genetically engineered foods, it is posted below. Or you may

read it at the FDA's web site at:

http://www.fda.gov/ola/2005/bioengineered0614.html

 

Contrary to what Director Brackett stated to Congress, the regulation of

genetically engineered foods in the United States is entirely inadequate. At

the very least, we need all genetically engineered foods to be labeled and

safety tested.

 

Craig Winters

Executive Director

The Campaign to Label Genetically Engineered Foods

 

The Campaign

PO Box 55699

Seattle, WA 98155

Tel: 425-771-4049

E-mail: label

Web Site: http://www.thecampaign.org

 

Mission Statement: " To create a national grassroots consumer campaign for

the purpose of lobbying Congress and the President to pass legislation that

will require the labeling of genetically engineered foods in the United

States. "

 

***************************************************************

 

Health effects of GM foods need further study, WHO says

 

Food Navigator - USA

6/24/2005

http://www.foodnavigator-usa.com/news/printNewsBis.asp?id=60866

 

A call by the World Health Organisation for further safety assessments on

using genetically modified (GM) foods should give governments pause for

thought before giving their approval for their wider use of the technology.

 

In a report issued yesterday, the UN body finds that GM foods can increase

crop yield, food quality and the diversity of foods that can be grown in a

given area but warns against rushing to introduce novel types of genes into

the food chain.

 

The WHO report further complicates the international dispute over GM foods

which has left multinational companies with having to deal with different

sets of regulations depending on the countries in which they operate.

 

The sale of GM foods has put nations at loggerheads with each other. The EU

and Japan have enacted labelling and traceability requirements for GM food

products, while the US and Canada believe the technology is safe and that

such standards are not necessary. The US, Canada and Argentina have filed

cases with the World Trade Organisation against the EU's requirements.

 

WHO calls for a case-by-case risk assessment of each new GM food on its

effects on human health, on the food chain and on the environment rather

than a general endorsement by governments on the use of the technology to

create new types of crops or animals.

 

WHO notes that pre-market risk assessments have been performed on all GM

food products that are currently marketed. To date, the consumption of GM

foods has not caused any known negative health effects. Currently,

evaluations of GM primarily focus on the ecological and agricultural

ramifications and on possible health effects.

 

" However, some of the genes used to manufacture GM foods have not been in

the food chain before and the introduction of new genes may cause changes in

the existing genetic make-up of the crop, " WHO stated in its assessment.

" Therefore, the potential human health effects of new GM foods should always

be assessed before they are grown and marketed, and long-term monitoring

must be carried out to catch any possible adverse effects early. "

 

The organisation recommends such evaluations should be widened to include

social, cultural and ethical considerations, to help prevent what WHO calls

a " genetic divide " between groups of countries which do and do not allow the

growth, cultivation and marketing of GM products.

 

" Each country has different prevailing social and economic conditions, and

the people have different histories of what they eat and what food means in

their society, " WHO stated. " All of these factors can affect how GM foods

will be regarded, and taking proper account of these concerns will affect

the long-term acceptance or rejection of GM foods and their possible health

benefits and potential risks. "

 

There are now 15 international legally-binding instruments and nonbinding

codes of practice addressing aspects of GM organisms. Many developed

countries have established specific pre-market regulatory systems requiring

the rigorous case-by-case risk assessment of GM foods prior to their

release. Many developing countries lack the capacity to implement a similar

system, WHO stated.

 

In 2004 about 81m hectares of land was being used to grow GM crops by seven

million farmers in 18 countries, mainly the US, Argentina, Canada, Brazil,

China, Paraguay and South Africa.

 

The first major GM food was introduced on the market in the mid-1990s and

paved the way for the growing of strains of maize, soybeans, rapeseed and

cotton. GM varieties of papaya, potato, rice, squash, sugar beet and tomato

have been released in certain countries. WHO estimates that at the end of

2004 GM crops covered about four per cent of the total global arable land.

 

Most of the GMOs commercialised so far in developing countries have been

acquired from developed countries and focus on a limited number of traits,

mainly herbicide tolerance and insect pest resistance, and crops such as

cotton, soybean and maize. Research is also underway on GM seafood and

animals.

 

Many food-processing aids, such as enzymes, produced through the use of GM

microorganisms have been on the market for over a decade and are used in a

wide variety of processed foods. No live GM food microorganisms have been

introduced onto the market yet, WHO stated.

 

Current EU requires that all food be tracked and labelled if it contains 0.9

per cent or more traceable GM content, along with derivatives such as paste

and ketchup from a GM tomato. Products derived from GM processing aids, such

as GM enzymes or yeast, are not affected. Inciting strong criticism from

environmental groups, this year a panel of scientists at the European Food

Safety Authority (EFSA) cleared a variety of genetic maize known as 1507 for

cultivation. Maize 1507 is made jointly by Pioneer Hi-Bred International, a

subsidiary of DuPont, and Mycogen seeds, a Dow AgroSciences unit.

 

Biotechnology, in its technical sense, refers to plant and animal farming

techniques that alter living organisms to make or modify food products.

There are many possible products from transgenic plants, plant parts, and

processed foodstuffs, including highly refined substances such as vegetable

oil containing little or no detectable transgene-derived protein or DNA.

 

Under the Cartagena Protocol on Biosafety, governments will signal whether

or not they are willing to accept imports of agricultural commodities that

include GMOs by communicating their decision via an Internet-based Biosafety

Clearing House.

 

***************************************************************

 

Statement of

Robert E. Brackett, Ph.D., Center for Food Safety and Applied Nutrition

 

before

Committee on Agriculture, Nutrition and Forestry

United States Senate

 

June 14, 2005

 

Introduction

Mr. Chairman and Members of the Committee, I am Robert Brackett, Director,

Center for Food Safety and Applied Nutrition at the Food and Drug

Administration (FDA or the Agency). Thank you for the opportunity to testify

today on FDA's regulatory program for foods derived from bioengineered

plants, also known as genetically engineered, or bioengineered, foods.

 

Background

Within FDA, the Center for Food Safety and Applied Nutrition (CFSAN)

oversees bioengineered plant-derived food and ingredients intended for human

consumption. Our Center for Veterinary Medicine (CVM) oversees bioengineered

plant-derived products used as animal feed or as ingredients in animal feed,

as well as bioengineered products used to improve the health or productivity

of animals. My testimony this morning focuses on bioengineered plant-derived

foods. Let me also clarify that in the Federal Food, Drug, and Cosmetic

(FD & C) Act, food is defined as food for man or other animals. So, when I

talk about food, it also encompasses animal feed unless stated otherwise.

 

We believe it is very important for the public to understand how FDA is

regulating the bioengineered foods being introduced into the marketplace and

to have confidence in that process. Therefore, I appreciate this opportunity

to describe our policies and procedures.

 

First, let me state that FDA is confident that the bioengineered foods on

the United States market today are as safe as their conventional

counterparts. This conclusion has been echoed in recent reports by the

National Academy of Sciences (NAS) and the Government Accountability Office,

and most recently in a 2004 report from NAS's National Research Council and

Institute of Medicine entitled, " Safety of Genetically Engineered Foods:

Approaches to Assessing Unintended Health Effects. " Over the last ten years,

FDA has reviewed the data on more than 60 bioengineered food products,

ranging from herbicide resistant soybeans to a modified canola oil. To date,

the evidence shows that these foods are as safe as their conventional

counterparts.

 

In a 1992 policy statement on bioengineered foods, FDA announced that the

Agency was " not aware of any information showing that foods derived by these

new methods differ from other foods in any meaningful or material way, or

that, as a class, foods developed by the new techniques present any

different or greater safety concern than foods developed by traditional

plant breeding. " This 1992 statement and its scientific underpinnings still

reflect FDA's thinking about bioengineered foods.

 

Crossbreeding, Hybridization, and Bioengineering

The selection and genetic improvement of plants for agricultural use has

been going on for thousands of years, although plant breeding as a science

only began in the late 1800s. Typically, plant breeding has involved

crossbreeding and hybridization, in which two related plants are

cross-fertilized, and the resulting offspring have characteristics of both

parent plants. In the breeding process, however, many undesirable traits

often can appear in addition to the desirable ones. Some of those

undesirable traits can be eliminated through additional breeding, which is

time-consuming. Breeders can then further select and reproduce the offspring

that have the desired traits. Many of the foods that are already common in

our diet are obtained from plant varieties that were developed using

conventional genetic techniques of breeding and selection. Hybrid corn,

nectarines (which could be considered genetically altered peaches), and

tangelos (which are a genetic hybrid of a tangerine and grapefruit) are all

examples of such breeding and selection.

 

Today, by inserting one or more genes into a plant, scientists are able to

produce a plant with new, advantageous characteristics. The new gene

splicing techniques are being used to achieve many of the same goals and

improvements that plant breeders historically have sought through

conventional methods. Today's techniques can be used with greater precision

and allow for more complete characterization and, therefore, greater

predictability, of the qualities of the new variety. They give scientists

the ability to isolate genes and introduce new traits into foods without

simultaneously introducing undesirable traits. This is an important

improvement over traditional breeding. Any genetic modification technique,

including both traditional methods and bioengineering, could change the

composition of a food in a manner relevant to food safety. But because of

the increased precision offered by the bioengineered methods, the risk of

inadvertently introducing detrimental traits is actually likely to be

lessened. Bioengineering does expand the range of new proteins and other

substances that can be introduced into plants. However, the agencies have

well-established procedures for determining the safety of such new

substances.

 

FDA has found no evidence to indicate that deoxyribonucleic acid (DNA)

inserted into plants using bioengineering presents food safety problems. The

small amounts of the newly expressed proteins are generally unlikely to

change the safety profile of the plant. If safety concerns should arise,

however, they would most likely fall into one of three broad categories:

allergens, toxins, or anti-nutrients. FDA has extensive experience in

evaluating the safety of such substances in food.

 

As to potential allergens, foods normally contain many thousands of

different proteins. While the majority of proteins do not cause allergic

reactions, virtually all known human allergens are proteins. Since genetic

engineering can introduce a new protein into a food plant, it is possible

that this technique could introduce a previously unknown allergen into the

food supply or could introduce a known allergen into a " new " food. FDA's

guidelines help developers to identify this issue and address any concern

prior to marketing.

 

A second possible problem is the introduction of toxins into the food crop.

It is possible that a new protein could cause toxicity. A third possible

issue is the introduction of anti-nutrients, such as molecules like phytic

acid that binds essential dietary minerals such as phosphorus.

 

Breeding, whether bioengineering or otherwise, can cause unintended changes

in the composition of the food. For example, it might result in a reduction

of Vitamin C or an increase in the concentration of a naturally occurring

toxin in the food. Developers of bioengineered foods analyze the composition

of the foods from their new crop varieties to ensure that they do not market

foods whose composition differs from conventionally-derived counterparts.

 

It is important to note that the kinds of food safety testing typically

conducted by developers of a bioengineered food crop to ensure that their

foods meet all applicable requirements of the FD & C Act address these

potential concerns. In the event that something unexpected does occur, this

testing provides a way to detect such changes at the developmental stage and

defer marketing until any concern is resolved.

 

Legal and Regulatory Background

The overall Federal regulatory structure for biotechnology products, known

as the Coordinated Framework, was adopted by Federal agencies in 1986 (51 FR

23302, June 26, 1986). Under the Coordinated Framework, FDA regulates

bioengineered plant-derived food in conjunction with the United States

Department of Agriculture (USDA) and the Environmental Protection Agency

(EPA). FDA has authority under the FD & C Act to ensure the safety of all

domestic and imported foods for man or other animals in the U.S. market. The

exceptions to this are meat, poultry, and processed egg products, which are

regulated by USDA. The safety of animal drug residues in meat and poultry,

however, is regulated by FDA's CVM. Pesticides, including those

bioengineered into a food crop, are regulated primarily by EPA, which

reviews safety and sets tolerances (or establishes exemption from tolerance)

for pesticides. FDA enforces the pesticide tolerances set by EPA. USDA's

Animal & Plant Health Inspection Service (APHIS) oversees the agricultural

and environmental safety of planting and field testing of bioengineered

plants.

 

Bioengineered foods and food ingredients must adhere to the same standards

of safety under the FD & C Act that apply to their conventionally bred

counterparts. This means that these products must be as safe as the

traditional foods on the market. FDA has broad authority to initiate

regulatory action if a product fails to meet the requirements of the FD & C

Act.

 

FDA relies primarily on two sections of the FD & C Act to ensure the safety of

foods and food ingredients that are produced using biotechnology:

 

The adulteration provisions of section 402(a)(1). Under this postmarket

authority, FDA has the power to remove a food from the market (or sanction

those marketing the food) if the food poses a risk to public health. It is

important to note that the FD & C Act places a legal duty on developers to

ensure that the foods they market to consumers are safe and comply with all

legal requirements.

 

The food additive provisions in section 409. Under this section, a substance

that is intentionally added to food is a food additive, unless the substance

is generally recognized as safe (GRAS) or is otherwise exempt (e.g., a

pesticide, the safety of which is overseen by EPA). Unapproved food

additives are subject to the adulteration provisions in 402 (a)(2)© of the

FD & C Act.

 

The FD & C Act requires premarket approval of any food additive, regardless of

the technique used to add it to food. Thus, substances introduced into food

are either: (1) new food additives that require premarket approval by FDA;

or (2) GRAS, and are therefore exempt from the requirement for premarket

review by FDA. Generally, foods such as fruits, vegetables, and grains are

not subject to premarket approval under the FD & C Act because they have been

safely consumed over many years. Other than the food additive system, there

are no FDA premarket approval requirements for foods generally.

 

In 1992, recognizing that bioengineered products were on the horizon, FDA

published a policy explaining how existing legal requirements would apply to

products developed using the tools of biotechnology (57 FR 22984; May 29,

1992; " Statement of Policy: Foods Derived from New Plant Varieties " ). The

1992 policy was designed to answer questions about these products and to

assist developers prior to marketing to meet their legal duty to provide

safe and wholesome foods to consumers. The basic principle of the 1992

policy is that the traits and characteristics of the foods should be the

focus of safety assessment for all new varieties of food crops, no matter

which techniques are used to develop them.

 

Under FDA policy, a substance that would be a food additive if it were added

during traditional food manufacturing is also treated as a food additive if

it is introduced into food through bioengineering of a food crop. Our

authority under section 409 permits us to require premarket approval of any

food additive and, thus, to require premarket approval of any substance

intentionally introduced via bioengineering that is not GRAS.

 

Examples ofsubstances intentionally introduced into food that would be

reviewed as food additives include those that have unusual chemical

functions, have unknown toxicity, or would be new major dietary components

of the food. For example, a novel sweetener bioengineered into food would

likely require premarket approval. In our experience with bioengineered food

to date, however, we have reviewed only one substance under the food

additive provisions, an enzyme produced by an antibiotic resistance gene

(kanamycin), and we granted approval as a food additive. In general,

substances intentionally added to or modified in food via biotechnology to

date have been proteins and fats that are, with respect to safety, similar

to other proteins and fats that are commonly and safely consumed in the diet

and, thus, are presumptively GRAS. Therefore, they have not needed to go

through the food additive approval process.

 

In 1994, following the 1992 policy, FDA conducted a comprehensive scientific

review for the first bioengineered product planned for introduction into the

market. FDA reviewed Calgene's data on the Flavr SavrT tomato and the use of

the kanamycin resistance marker gene. Calgene submitted food additive

petitions for the enzyme product of the marker gene for use in food and

feed. We subsequently approved the petitions. FDA also held a public meeting

of our Food Advisory Committee to examine applicability of the 1992 policy

to products such as the Flavr SavrT tomato. The Advisory Committee members

agreed with FDA that the scientific approach presented in the 1992 policy

was sound and that the questions regarding the Flavr SavrT had been

addressed. The Advisory Committee members also suggested that we provide an

expedited decision process for the marketing of bioengineered foods that do

not raise substantive scientific issues.

 

In response, FDA established a voluntary consultative process to help

companies comply with the FD & C Act's requirements for the bioengineered

foods that they intend to market. The results of our consultation are public

information and are available on our website. Since the consultation process

was created, companies have used the consultative process more than 60 times

as they sought to introduce genetically altered plants representing more

than 16 different crops into the U.S. market. We are not aware of any

bioengineered plant-derived food intended for commercialization that is

subject to FDA's jurisdiction that has not been evaluated by FDA through the

current consultation process.

 

Typically, the consultation begins early in the product development stage,

before it is ready for market. Company scientists and other officials meet

with FDA scientists to describe the product they are developing. In

response, the Agency advises the company on what tests would be appropriate

for the company to assess the safety of the new food.

 

After the studies are completed, the data and information on the safety and

nutritional assessment are provided to FDA for review. The Agency evaluates

the information for all of the known hazards and also for potential

unintended effects on plant composition and nutritional properties, since

plants may undergo changes other than those intended by the breeders. For

example, FDA scientists evaluate data and information to assure that the

newly expressed compounds are safe for food consumption, and that there are

no allergens new to the food, no increased levels of natural toxicants, and

no reduction of important nutrients. They also determine whether the food

has been changed in any substantive way such that the food would need to be

specially labeled to reveal the nature of the change to consumers.

 

Some examples of the information reviewed by FDA include:

 

The name of the food and the crop from which it is derived;

The uses of the food, including both human food and animal feed uses;

The sources, identities, and functions of introduced genetic material and

its stability in the plant;

The purpose or intended technical effect of the modification and its

expected effect on the composition or characteristic properties of the food

or feed;

The identity and function of any new products encoded by the introduced

genetic material, including an estimate of its concentration;

A comparison of the composition or characteristics of the bioengineered food

to that of food derived from the parental variety or other commonly consumed

varieties with special emphasis on important nutrients, anti-nutrients, and

toxicants that occur naturally in the food;

Information on whether the genetic modification altered the potential for

the bioengineered food to induce an allergic response; and

Other information relevant to the safety and nutritional assessment of the

bioengineered food.

If a plant developer used a gene from a source whose food is commonly

allergenic, FDA would presume that the modified food may be allergenic. The

developer, however, is allowed the opportunity to demonstrate that such food

would not cause allergic reactions in persons allergic to food from the

source.

 

If FDA scientists have questions about the safety data, the company may, for

example, provide more detailed answers or conduct additional studies. Our

experience has been that no bioengineered product has gone on the market

until FDA's questions about the safety of the product have been answered.

 

Labeling

Section 403 of the FD & C Act sets labeling requirements for all foods. All

foods, whether derived using bioengineering or not, are subject to these

labeling requirements.

 

Under section 403(a)(1) of the FD & C Act, a food is misbranded if its

labeling is false or misleading in any particular way. Section 201(n) of the

FD & C Act provides additional guidance on how labeling may be misleading. It

states that labeling is misleading if it fails to reveal all facts that are

" material in light of such representations (made or suggested in the

labeling) or material with respect to consequences which may result from the

use of the article to which the labeling or advertising relates under the

conditions of use prescribed in the labeling or advertising thereof or under

such conditions of use as are customary or usual. "

 

Although the legislative history of section 201(n) contains little

discussion of the word " material, " there is precedent to guide the Agency in

its decision regarding whether information on a food is in fact material

within the meaning of 201(n). Historically, the Agency has generally limited

the scope of the materiality concept to information about the attributes of

the food itself. FDA has required special labeling on the basis of it being

" material " information in cases where the absence of such information may:

(1) pose special health or environmental risks (e.g., warning statement on

certain protein diet products); (2) mislead the consumer in light of other

statements made on the label (e.g., requirement for quantitative nutrient

information when certain nutrient content claims are made about a product);

or (3) in cases where a consumer may assume that a food, because of its

similarity to another food, has nutritional, organoleptic (i.e., affects

taste, color, odor, or feel), or functional characteristics of the food it

resembles when in fact it does not (e.g., reduced fat margarine may not be

suitable for frying).

 

FDA does not require labeling to indicate whether a food or food ingredient

is a bioengineered product, just as it does not require labeling to indicate

which conventional breeding technique was used in developing a food plant.

Rather, any significant differences in the food itself have to be disclosed

in labeling. If genetic modifications materially change the composition of a

food product, these changes must be reflected in the food's labeling. This

would include its nutritional content (for example, more oleic acid, or

greater content of the amino acid lysine) or requirements for storage,

preparation, or cooking, which might impact the food's safety

characteristics or nutritional qualities. For example, one soybean variety

was modified to alter the levels of oleic acid in the beans. Because the oil

from this soybean is significantly different when compared to conventional

soybean oil, we advised the company to adopt a new name for that oil, a name

that reflects the intended change.

 

If a bioengineered food were to contain an allergen not previously found in

that food, information about the presence of the allergen would be material

as to the potential consequences of consumption of the food. If FDA

determined that labeling would be sufficient to enable the food to be safely

marketed, the Agency would require that the food be labeled to indicate the

presence of the allergen.

 

FDA has received comments suggesting that foods developed through modern

biotechnology should bear a label informing consumers that the food was

produced using bioengineering. We have given careful consideration to these

comments. However, we do not have data or other information to form a basis

for concluding that the fact that a food (or any of its ingredients) was

produced using bioengineering is material within the meaning of 201(n) and,

therefore, constitutes information that must be disclosed as part of a

bioengineered product's labeling. Hence, we believe that we have neither a

scientific nor a legal basis to require such labeling. We have developed,

however, draft guidance for those who wish voluntarily to label either the

presence or absence of bioengineered food in food products.

 

The Agricultural Biotechnology Working Group

The interagency Agricultural Biotechnology Working Group, which includes the

Office of Science and Technology Policy (OSTP), FDA, EPA, USDA, and others,

has addressed regulatory issues related to the potential for low,

intermittent levels of materials from bioengineered food crops to

inadvertently get into food or feed.

 

In August 2002, OSTP published a Notice in the Federal Register (67 FR

50578) which proposed coordinated actions by FDA, EPA, and USDA aimed at

strengthening controls over field trials to address the potential of

material from field trials to inadvertently get into food or feed. As part

of this OSTP initiative, on November 24, 2004, FDA issued a draft guidance

document entitled, " Guidance for Industry: Recommendations for the Early

Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant

Varieties Intended for Food Use. " This draft guidance outlines procedures to

address the possible intermittent, low-level presence in food and feed of

new non-pesticidal proteins from biotechnology-derived crops under

development for food or feed use but that have not gone through FDA's

premarket consultation process. Under this guidance, FDA encourages

developers to submit protein safety information once field testing reaches a

stage of development such that there could be concerns that new

non-pesticidal proteins produced in the field-tested plants might be found

in food or feed. FDA's focus would be on proteins new to such plants because

FDA believes that any potential risk from the low level presence of such

material in the food supply would be limited to the possibility that it

would contain or consist of a new protein that might be an allergen or

toxin. FDA would still expect developers to conduct a complete consultation

with FDA prior to marketing food or feed from the plant, consistent with

current practices. The comment period for the draft guidance closed on

January 24, 2005. FDA is reviewing the approximately 3000 comments received

and expects to complete the final guidance by the end of the calendar year.

 

The Agricultural Biotechnology Working Group is also working on the issue of

pharmaceutical crops. FDA has the authority and responsibility for

regulating pharmaceuticals, including human biologics, whether they are

produced in traditional manufacturing facilities or from crops in the field.

Regulations found in parts 210 & 211 of Title 21 of the Code of Federal

Regulations outline practices that must be followed by pharmaceutical

manufacturers as part of good manufacturing practice. These regulations are

general in nature and apply to all pharmaceutical manufacturing

methodologies, including plant-made pharmaceuticals. For crops in the field,

however, there are particular issues to be addressed, for example, the

disposition of the residual crop left over after a pharmaceutical is

extracted. The interagency working group is working to clarify authorities

for regulating genetically engineered crops ordinarily used to produce food

(e.g., corn), whether they are intended for food, pharmaceutical, or

industrial use, and to make sure there are no gaps in protecting human

health and the environment. We are evaluating ways to help keep

pharmaceutical and industrial compounds out of food when they are not

supposed to be there. We are looking at ways that would be science- and

risk-based, enforceable, complementary with the USDA-APHIS regulatory

scheme, and that would not pose too high a barrier to development of these

products.

 

In September 2002, FDA and USDA jointly published the Draft Guidance for

Industry on the use of bioengineered plants or plant materials to produce

biological products, including medical devices, new animal drugs, and

veterinary biologics. This draft guidance, which contains sections on FDA

oversight and sections on APHIS oversight, outlines the important scientific

questions and information that should be addressed to FDA by those who are

using bioengineered plants to produce medical or veterinary drug products.

FDA and USDA are working to finalize this guidance document.

 

Other Activities

FDA has made a commitment to ensuring that consumers have access to

information about new bioengineered food products in a timely fashion and

has made more information about these foods available on FDA's website.

 

To ensure that FDA has the best scientific advice on issues related to

bioengineered foods, we have added experts in this field to our foods and

veterinary medicine advisory committees and created a Food Biotechnology

Subcommittee of the Food Advisory Committee.

 

In addition, NAS has formed a standing Committee on Agricultural

Biotechnology, Health and the Environment. FDA, EPA and USDA requested that

the committee assess the potential for unintended effects of genetically

engineered foods and how to evaluate their impact on human health. The

committee's report, " Safety of Genetically Engineered Foods: Approaches to

Assessing Unintended Health Effects, " was published in July 2004. According

to the committee, all evidence evaluated to date indicates that unexpected

and unintended compositional changes arise with all forms of genetic

modification, including conventional methods and genetic engineering

techniques. The committee noted that a " policy to assess products based

exclusively on their method of breeding is scientifically unjustified. " The

committee recommended that compositional changes that result from any method

of genetic modification in food, including genetic engineering, undergo an

appropriate safety assessment. The committee presented an approach to

scientifically assess whether unintended effects that result from the

genetic modification could lead to adverse health concerns. The approach

suggested by the committee is generally consistent with FDA's approach.

 

FDA provided international leadership in the work of the Codex Ad Hoc

Intergovernmental Task Force on Foods Derived from Biotechnology, a task

force established for a four-year time span by the Codex Alimentarius

Commission (Codex). The work of this task force was especially important

because it developed internationally accepted principles and guidelines for

the evaluation of the safety of bioengineered foods. Those principles and

guidelines were adopted by Codex in 2003, at the conclusion of the life of

the task force. These principles and guidelines are the international

standards for ensuring the safety of genetically engineered foods, and they

are consistent with FDA's approach. Codex recently re-established the task

force for another four-year span. It will have its first meeting this coming

September, when it will decide on new work.

 

FDA also is actively participating as a member of the Organization for

Economic Cooperation and Development's Task Force for the Safety of Novel

Foods and Feeds. This task force is in the process of writing

scientific/technical consensus documents aimed at compiling current

information that is important in food and feed safety assessment. These

consensus documents serve as references to Codex and regulatory bodies.

 

Mr. Chairman, FDA, in cooperation with EPA and USDA, will continue its

oversight of new and emerging food biotechnology products and will be

vigilant in ensuring the safety and integrity of the food supply. I thank

you again for the opportunity to address these issues. I am happy to answer

any questions you might have.

 

 

 

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