Hexane a neurotoxic by-product of gasoline refining used in extracting DHA/ARA for baby formula

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Found at http://www.cornucopia.org/replacing-mother-infant-formula-report/Questions and AnswersAbout DHA/ARA and Infant FormulaWhat is DHA?DHA, which stands for docosahexaenoic acid, is a type of fat. This particular fatty acid isabundant in the gray matter of the human brain and in the membranes of the retinalphotoreceptors in the eyes.1 It is a 22-carbon long-chain polyunsaturated fatty acid of theomega-3 family. Research suggests that DHA from a mother’s breast milk benefits an infant’seye and brain development. For adults, some preliminary research points to cardiovascular andcognitive health benefits of DHA.What are good sources of DHA?For infants, the best source is undisputedly breast milk.Adults can acquire preformed DHA from sources such as fish, fish oil, beef, and egg yolks. Thehuman body can also synthesize DHA from other omega-3 fatty acids, such as those found innuts, flaxseeds, canola oil, and other foods.Where does the supplemental DHA in foods such as infant formula and organic milk comefrom?The DHA in infant formula and organic milk comes from docosahexaenoic single cell oil(DHASCO). These oils are extracted with the toxic chemical hexane from laboratory-grownalgae.Is the DHA found in infant formula equivalent to the DHA found naturally in breast milk?Algal DHA oils and fungal ARA oils contain DHA and ARA triglycerides that are not identicalto those found in human milk. In human milk, DHA is carried as a single molecule on atriglyceride. In DHASCO, the fungal DHA oil, the majority of DHA appears as a singlemolecule on the triglyceride chain, similar to human milk; however, two DHA molecules doappear on some triglycerides in DHASCO.2 Many components of DHASCO, which containsonly 40-50% DHA, are new to an infant’s diet.What is ARA?ARA stands for arachidonic acid, which is a 20-carbon omega-6 fatty acid. Like DHA, ARA isalso believed to be an important component of the central nervous system. If DHA is added,ARA must also be added to infant formula in order to maintain a balance of fatty acids.Where does ARA in infant formula come from?The ARA in infant formula comes from arachidonic single cell oil (ARASCO), which isextracted with the use of the toxic chemical hexane from a laboratory-grown soil fungus.What company manufactures the DHA and ARA that is found in infant formula?Martek Biosciences Corporation, based in Columbia, land. Their DHA and ARA are alsoknown as DHASCO and ARASCO—docosahexaenoic acid single cell oil and arachidonic acidsingle cell oil. These are "novel" and patented compounds.How are Martek’s DHA and ARA oils manufactured?To obtain the DHASCO, microorganisms such as Crypthecodinium cohnii are first grown undertightly controlled fermentation conditions in a nutrient solution containing glucose and yeastextract.3 They are then harvested, and the oil is extracted by blending the dried algae withhexane, a toxic solvent that is a by-product of gasoline refining, in a continuous extractionprocess. The hexane then is removed from the oil by distillation techniques, using conventionaloilseed processing equipment, which is suitable to perform the filtering, separation, anddistillation. 4ARASCO can be obtained from species of fungus such as Pythium insidiosum, or Mortierellaalpina, using similar production and extraction processes as for DHASCO.5What do scientific studies show regarding developmental benefits of adding DHASCO andARASCO to infant formula?Studies in both preterm and term infants have not consistently shown an effect of long-chainpolyunsaturated fatty acid supplementation on cognitive or behavioral performance.Overall, the scientific evidence is insufficient to conclude that supplementation with DHASCOand ARASCO benefits development.6What do scientific studies show regarding benefits to visual development?There is also inconsistency in the findings on visual development, although there is somewhatmore support in the scientific community that adding DHASCO and ARASCO benefits visualdevelopment.I’ve heard claims that DHA and ARA in infant formula will make babies smarter. Is thistrue?Although a number of trials have attempted to prove this thesis, no study has ever shown thatinfant-formula-fed babies were better off, developmentally or otherwise, than human-milk-fedbabies.Claims that DHA/ARA-supplemented infant formula will make babies smarter come from infantformula manufacturers, who, along with Martek, have been happy to profit from DHA/ARAsupplementedinfant formula.Is infant formula with DHASCO/ARASCO more expensive than formula without theseoils?Yes, infant formula with DHASCO/ARASCO is priced at 15 to 30% more than standardformula. The International Baby Food Action Network (IBFAN) estimates that infant formulasupplemented with DHASCO/ARASCO costs parents an additional $200 per year.7 This hascost American taxpayers millions of dollars in increased cost for providing "new and improved"infant formula to low income mothers eligible for subsidized feeding programs.Have these oils been thoroughly tested for safety?According to a panel of independent scientists convened by the Institute of Medicine, premarketsafety tests for these oils were inadequate. They concluded that too few safety tests wereperformed. Certain tests were performed only on rats, when they should have been performed onnonhuman primates as well. No chronic toxicity or chronic carcinogenicity studies wereperformed, not even on rats. In fact, none of the “long-term” safety tests lasted for longer than 90days. A more comprehensive testing protocol is currently taking place …. on our nationsunsuspecting children.What did the results of the premarket safety tests show?Out of 13 tests performed on rats, 5 showed increased liver weights in rats fed the highest doseof Martek’s DHA oils. Other study results showed increased spleen weights. There was alsoevidence of increased albumin and/or protein levels in rats fed Martek’s DHASCO andARASCO.Have there been reported problems with DHASCO and ARASCO in infant formula?Yes. Hundreds of reports have been submitted to the FDA regarding adverse reactions in infantsconsuming formula with DHASCO and ARASCO. Of these reports, 98 could be traced to theDHA and ARA oils (for example, by stating that symptoms disappeared as soon as the infantwas given a non-DHA/ARA formula).What are the adverse reactions experienced by some infants consuming DHA/ARAsupplementedformula?Watery, explosive diarrhea, in many cases long-term, is the most commonly reported side effect.Vomiting, bloating, gastrointestinal discomfort, rashes, and seizures have also been reported.These are quite serious complications and a vulnerable population.Why did FDA allow these oils to be added to infant formula?Requirements for infant formula are found in the Federal Food, Drug, and Cosmetic Act, whichstates that “all manufacturers of infant formula must begin with safe food ingredients, which areeither generally recognized as safe (GRAS)8 or approved as food additives for use in infantformula.”9Martek’s DHASCO and ARASCO were granted GRAS status in 2001. The FDA has noauthority to stop the addition of ingredients if they have GRAS status. However, the FDA itselfdid not affirm the safety of Martek’s DHASCO and ARASCO for use in infant formula, citingreports of “adverse events and other morbidities including diarrhea, flatulence, jaundice, andapnea in infants fed long-chain polyunsaturated fatty acids.”I have read in marketing literature from infant formula manufacturers that DHA/ARA--supplemented infant formula is “as close as ever to breast milk.” Is this true?Breast milk contains elements that simply cannot be grown or manufactured for infant formula—these elements include live cells, enzymes, and bioactive compounds.10 Many of these haveprofound immune enhancing properties. Moreover, breast milk is a dynamic fluid, meaning thatit changes over time and depending on the infant’s needs. As the perfect food for babies, breastmilk simply cannot be imitated by infant formula manufacturers; and any claims that their infantformula comes close to breast milk are false.Manufacturers claim that it is “as close as ever to breast milk,” so does formula withDHASCO and ARASCO confer the same benefits as breast milk?No. Formula-fed infants—whether the formula contains DHA/ARA or not—have increased ratesin the incidence and/or severity of a wide range of infectious diseases including bacterialmeningitis, bacteremia, diarrhea, respiratory tract infection, necrotizing enterocolitis, otitismedia, urinary tract infection, and late-onset sepsis in preterm infants. Formula feeding iscorrelated with an increase in incidence of insulin-dependent (type 1) and non-insulin-dependent(type 2) diabetes mellitus.11Formula-fed infants are also more likely to die of sudden infant death syndrome in the first yearof life.12As children and adults, formula-fed infants have an increased likelihood of developinglymphoma, leukemia, and Hodgkin’s disease; overweight and obesity; hypercholesterolemia; andasthma.13What are the current rates of breastfeeding in the United States?Upon discharge from the hospital, 72.9% of mothers in the United States breastfeed, but onlyapproximately half of mothers breastfeed one week after discharge from the hospital.These numbers drop even more dramatically as the infant grows, with exclusive breastfeeding at3 months of age at 38.7%, and only 13.9% at 6 months of age.14Do federal regulations permit the addition of Martek’s DHASCO and ARASCO oils toorganic infant formula?No, federal organic regulations prohibit hexane-extracted ingredients in organic foods.The federal organic regulations also specify which nonagricultural products may be added toorganic foods; DHASCO and ARASCO are not on the National List of Approved Substances,nor are “by-products of microorganisms.”Given the adverse reactions that these chemically processed ingredients have caused in someinfants, Martek’s DHASCO and ARASCO do not belong in organic products. Organicconsumers trust that only safe and natural ingredients are used, especially in foods purchased forinfants.Why are there infant formulas on store shelves that are both certified organic and containMartek’s DHASCO and ARASCO?These DHA and ARA oils appear to be added to the organic infant formula in violation of thefederal organic standards. A formal legal complaint was filed in 2006, but a USDA complianceofficer dismissed the complaint despite clear language in the federal regulations prohibiting thesesubstances. Such dismissal of a formal legal complaint essentially gives a green light tomanufacturers to add these illegal additives without fear of enforcement by the USDA. TheCornucopia Institute believes that such clandestine changes of the organic rules, subsequent tosecret negotiations with industry lobbyists, were illegal.This industry-friendly ruling by the USDA—again, apparently in conflict with the law governingorganic food production and labeling—occurred after heavy lobbying from some of the largestagribusiness concerns in the country. The Cornucopia Institute is currently researching avenuesfor redress.What is hexane—the chemical used to extract Martek’s DHASCO and ARASCO?Hexane is a chemical by-product of gasoline refining.15 It is used not only as an extractionsolvent for edible oils, but also as a solvent for glues, varnishes, and inks and as a cleaning agentin the printing industry. Hexane is a neurotoxin and a hazardous air pollutant.Is hexane a concern for consumer health?The common assumption is that all toxic hexane residues evaporate from the oils before reachingthe consumer. However, no test results for Martek’s DHASCO and ARASCO confirming thisassumption are available to consumers. Scientists who have tested hexane residues in other oilshave found residues in some samples.16The effects of consuming foods that contain hexane-extracted ingredients are not known. As withmost of the approximately 70,000 chemicals that are registered with the EPA for commercialuse, hexane has been tested for its effects on workers (see below) but has not been tested for itseffects on consumers.17Other hydrocarbon solvents, like benzene, can interfere with human development, causing aspectrum of disorders including structural birth defects, hyperactivity, attention deficits, reducedIQ, and learning and memory deficiencies. No such data is available for hexane, which is also ahydrocarbon solvent.18 There is good justification, based on the precautionary principle, as towhy hexane is banned in organic food products.Is hexane toxic to workers in the processing plants?Yes. The use of hexane presents occupational health hazards to workers in the manufacturingplants, according to the Occupational Health and Safety Administration (OSHA). Effects ofexposure to hexane include headache, nausea, respiratory tract irritation, blisters, and blurredvision.19Hexane is an occupational safety hazard for another reason: it is highly explosive. Deadlyexplosions in manufacturing plants have been linked to hexane. While no deadly explosion hasoccurred at Martek production plants, their use of this dangerously explosive solvent putsworkers at risk.Is hexane a pollutant?Yes. Hexane is listed as a one of 188 Hazardous Air Pollutants by EPA.20 Hexane, like othervolatile organic compounds (VOCs), reacts with other pollutants, principally oxides of nitrogen,in the presence of sunlight to form ozone (O3). While ozone is essential in the upper atmosphere,excess ozone at ground level—a major contributor to “smog”—is a serious pollutant.21According to the EPA, there are also trace quantities of solvent in processing plants’wastewater.22 Martek was cited for polluting water with hexane from their Winchester,Kentucky, processing plant after it caused an explosion at a wastewater treatment plant.Consumers assume when they purchase organic products that they are supporting a higherenvironmental ethic. The use of hexane as a processing agent in organic food production is abetrayal to these ideals.Additional questions about the inclusion of DHA/ARA oils in organic foods:Which official rule determines whether algal DHA and fungal ARA oils are allowed inorganic foods?Under section 6517(d) of the Organic Food Production Act of 1990, nonagricultural ingredients,like algal DHA and fungal ARA oils, must appear as an approved substance on the National Listof Approved and Prohibited Substances (7 CFR 205.605).Algal DHA and fungal ARA oils do not appear as approved nonagricultural substances on theNational List and therefore appear to be added illegally.Who decides which additives are on the National List and therefore allowed in organicfoods?The law specifies that the Secretary of Agriculture may not propose changes to the National Listwithout input and recommendations from the National Organic Standards Board (NOSB), madeup of 15 expert citizen members from the organic community. After receiving recommendationsfrom the NOSB, the law states that the Secretary must publish any proposed changes in theFederal Register and seek public comment on proposals. Only after considering input from thepublic may the Secretary publish a revised National List in the federal register.Algal DHA and fungal ARA oils were never recommended by the NOSB and no proposed rulechange regarding these oils was ever made available for public review. They do not appear onthe National List as approved substances.If these oils do not appear on the National List of Approved and Prohibited Substances,why are we finding them in organic foods?This appears to be a troubling case of corporate lobbying supplanting democracy. If anonagricultural substance, like algal and fungal oil, does not appear on the National List as anapproved substance, they cannot be legally added to organic foods. However, it appears thatcertain companies have lobbied top political appointees at the USDA to ignore these laws andregulations.A compliance officer of the Agricultural Marketing Service, which oversees the NationalOrganic Program, dismissed a formal legal complaint regarding algal DHA and fungal ARA oils.Following this dismissal, the National Organic Program distributed this compliance letter to allcertifiers. This sent a message that the USDA will not take enforcement action against thosebreaking the rules by adding these illegal additives, essentially giving a green light to foodcompanies to break the law without compunction.On what grounds did the compliance officer dismiss the formal legal complaint?The compliance officer wrote that the “NOP determined that the use of synthetic vitamins,minerals and accessory nutrients are allowed in the production of products to be sold, labeled orrepresented as organic under the NOP, provided they are used in full compliance with FDA rulesand regulations and the National List.”It is truly disturbing to see a compliance officer misrepresent the official federal regulations inorder to dismiss a legitimate legal complaint, probably due to pressure of corporate lawyers andlobbyists. The official National List—as recommended by the National Organic Standards Boardand reviewed by the public—states that “synthetic vitamins and minerals” are allowed in organicfoods, but does not include accessory nutrients. Yet the compliance officer wrote that the “NOPdetermined that the use of synthetic vitamins, minerals and accessory nutrients are allowed,”adding “accessory nutrients” with no legal basis for doing so.Basically, these oils contain fatty acids—not vitamins or minerals. This is clearly not a case ofinvoluntary confusion regarding basic nutrition and the difference between vitamins, mineralsand fatty acids. It appears that the compliance officer willfully misrepresented federal regulationsin favor of corporate pressure to allow these illegal additives.Back in 1995, the National Organic Standards Board did recommend that “vitamins,minerals and accessory nutrients” be allowed in organic foods. So wouldn’t it bepermissible to include accessory nutrients in organic foods based on this recommendation?No, for several reasons.The National Organic Standards Board does not determine final regulations. They recommendamendments to the National List, which do not become official until they are published in theFederal Register. Before such rule changes can take place, the Secretary of Agriculture isrequired by law to share the proposed changes with citizens, by publication in the FederalRegister, and consider public input. “Accessory nutrients” do not appear in the official,published regulations and no formal public comment period took place.The NOSB never voted to list "accessory nutrients" on the national list, but recommended theybe allowed only when required by law or recommended by professional organizations. AlgalDHA and fungal ARA oils are neither required by law nor have they been recommended by aprofessional organization. In fact, the Institute of Medicine has published a book on novelingredients in infant formula, in which scientists express reservations concerning the safety ofDHA and ARA oils.Finally, algal DHA and fungal ARA oils contain only 40-50% DHA and ARA fatty acids, andare therefore not pure nutrients. As food products it is unclear whether they would even qualifyas “accessory nutrients.”Given our prior experiences in working with the USDA and their adjudication of formal legalcomplaints, we have to operate on the assumption that high-level political appointees reviewedand approved this erroneous application of the law.1 Salem ,N.J., Kim, H.-Y., Yergey, J.A. (1986) Docosahexaenoic acid: membrane function andmetabolism. In Health Effects of Polyunsaturated Fatty Acids in Seafoods, pp. 263–317.Academic Press, New York.2 Martek Biosciences Corporation. Opinion of an expert panel on the Generally Recognized AsSafe status of ARA and DHA single cell oils for infants and children. December 1999. Page 10.Available online at http://www.fda.gov/ohrms/dockets/dailys/00/mar00/030900/rpt0003.pdf.Last accessed on July 17, 2007.3 Patent 5,374,657 by J. , Martek Biosciences Corporation.4 Opinion of an expert panel on the Generally Recognized As Safe status of ARA and DHAsingle cell oils for infants and children. Martek Biosciences Corporation. December 1999.Section 5.1.35 Patent 5,374,657 by J. , Martek Biosciences Corporation.6 McCann, J.C., Ames, B.N. (2005) Is docosahexaenoic acid, an n-3 long-chain polyunsaturatedfatty acid, required for development of normal brain function? An overview of evidence fromcognitive and behavioral tests in humans and animals. American Journal of Clinical Nutrition82, 2: 281-295.7 International Baby Food Action Network. (2004) Breaking the rules, stretching the rules 2004:evidence of violations of the international code of marketing of breastmilk substitutes andsubsequent resolutions, edited by Yeong Joo Kean and Annelies Allain. Available online athttp://www.ibfan.org/english/pdfs/btr04.pdf. Last accessed on July 17, 2007.8 Under sections 201(s) and 409 of the Act, and FDA's implementation of regulations in 21 CFR170.3 and 21 CFR 170.30, the use of a food substance may be GRAS either through scientificprocedures or, for a substance used in food before 1958, through experience based on commonuse in food. http://www.cfsan.fda.gov/~dms/grasguid.html9 FDA (2007) Infant formula. Available online at http://www.cfsan.fda.gov/~dms/inf-toc.html.10 Food and Nutrition Board (2004) Infant formula: evaluating the safety of new ingredientsFood and Nutrition Board, Institute of Medicine, National Academies Press. Page 44.11 American Academy of Pediatrics (2005) Breastfeeding and the use of human milk. Pediatrics115, 2: 496–50612 American Academy of Pediatrics (2005) Breastfeeding and the use of human milk. Pediatrics115, 2: 496–50613 Ip, S., Chung, M., Raman, G., Chew, P., Magula, N., DeVine, D., Trikalinos, T., Lau, J. (2007)Breastfeeding and maternal and infant health outcomes in developed countries. EvidenceReport/Technology Assessment No. 153 (Prepared by Tufts-New England Medical CenterEvidence-based Practice Center, under Contract No. 290-02-0022). AHRQ Publication No. 07-E007. Rockville, MD: Agency for Healthcare Research and Quality.14 United States Centers for Disease Control and Prevention. NIS National Immunization Study2005 data. Available online at http://www.cdc.gov/breastfeeding/data/NIS_data/data_2005.htm.15 EPA (200) Technology Transfer Network Air Toxics web site. Hexane. Available online athttp://www.epa.gov/ttn/atw/hlthef/hexane.html.16 Joint Campaign Basel City (specialist laboratory) and Basel Country. Vegetable oils / fatty acidcomposition, hexane residues, declaration, pesticides (organic culinary oils only). Availableonline at http://www.labor.bs.ch/files/berichte/Report0424.pdf. Last accessed on October 22,2007.17 Oleskey, C., McCalley, M. A guide to biomonitoring of industrial chemicals. Center forChildren’s Health and the Environment. Available online athttp://www.childenvironment.org/pdfs/bmguide.pdf.18 Oleskey, C. and McCalley, M. A guide to biomonitoring of industrial chemicals. Center forChildren’s Health and the Environment. Available online athttp://www.childenvironment.org/pdfs/bmguide.pdf.19 OSHA. Occupational safety and health guideline for n-hexane. Available online athttp://www.osha.gov/SLTC/healthguidelines/n-hexane/recognition.html.20 EPA (2007) Technology Transfer Network Air Toxics web site. The Clean Air ActAmendments of 1990 List of Hazardous Air Pollutants. Available online athttp://www.epa.gov/ttn/atw/orig189.html. Note: EPA is required to control 188 hazardous airpollutants.21 EPA (2007) Ground Level Ozone. Available online at http://www.epa.gov/air/ozonepollution/.22 The source of these residues is direct contact steam in the distillation stripper anddesolventizer-toaster. Midwest Research Institute and EPA (1995) Emission factordocumentation for AP-42 Section 9.11.1 Vegetable oil processing final report for U. S.Environmental Protection Agency Office of Air Quality Planning and Standards Emission Factorand Inventory Group.