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Food Safety - Can FDA Be Trusted?
By Pete Kennedy

Sign the petition to Reject S.510

Aside from the question of whether the food safety bills before Congress will reduce the number of foodborne illnesses in the United States and promote the public health, there is also the consideration of whether the Food and Drug Administration (FDA) will enforce the provisions of any food safety bill that passes in a way that will be in the best interest of the American people.  The agency’s history indicates that it will not.

The agency has a long track record of either enforcing the law or not enforcing the law in ways that are favorable to the pharmaceutical and biotechnology industries at the expense of public health.  Two examples of the threat to public health created by agency favoritism can be found in FDA’s enforcement policy regarding the nontherapeutic use of antibiotics in animal feed and in the agency’s stance on genetically modified foods.  FDA policy in these areas provides a warning about what can potentially happen with the increased power and resources FDA will have if any current food safety bill is passed.

NON-THERAPEUTIC USE of ANTIBIOTICS in ANIMAL FEED

On March 17, 2009, Rep. Louise Slaughter (D-NY) introduced HR 1549, “The Preservation of Antibiotics for Medical Treatment Act of 2009″.   The purpose of the bill is “to amend the Federal Food, Drug and Cosmetic Act to preserve the effectiveness of medically important antibiotics used in the treatment of human and animal diseases”[1].  Rep. Slaughter, a microbiologist by training, had become alarmed at the widespread use of medically important human antibiotics for non-therapeutic purposes in animals.  In a March 2009 interview with Reuters, she remarked, “We are losing the ability to treat humans.  We have misused one of the best scientific products we have” [2–para. 16].

In the words of the advocacy group, Keep Antibiotics Working, the danger is that

“low-level use of antibiotics for extended periods of time [which is what pigs, cattle and poultry receive in this country] is one of the best ways to speed the development of antibiotic resistant bacteria [. . . .] 

     “The same mechanisms by which bacteria in humans develop resistance also work in animals that are fed antibiotics.  The genes that confer antibiotic resistance to bacteria can travel from food animals to humans via several routes, including on contaminated food and through contamination of the environment.

     “Many of the antibiotics routinely given to healthy livestock and poultry to promote growth are identical, or nearly so, to drugs that health providers rely on to treat sick humans.” [3]

A look at the Findings section of HR 1549 shows the extent of the problem and just how lucrative antibiotic use in farm animals has been for the pharmaceutical industry.  According to it, “an estimated 70 percent of the antibiotics and other antimicrobial drugs used in the United States are fed to farm animals for nontherapeutic purposes, including growth promotion” and compensating for “crowded, unsanitary, and stressful farming and transportation conditions” [1–Sec. 2(5)(A) ].  Moreover, these nontherapeutic uses in animals typically do not require a prescription. 

Threat to Public Health

Some of the findings in the bill on the threat that the nontherapeutic use of antibiotics in animals presents to public health include:

1.   A federal interagency task force released an action plan in January 2001 to address the continuing decline in effectiveness of antibiotics against common bacterial infections, referred to as ‘antibiotic resistance.’   The task force concluded that antibiotic resistance is “a growing menace to all people and poses a serious threat to public health” [1–Sec. 2(1)(B)].  The task force also warned that “if current trends continue, treatment for common infections will become increasingly limited and expensive, and, in some cases, nonexistent” [1–Sec. 2(1)(C)].  Moreover, “any overuse or misuse of antibiotics contributes to the spread of antibiotic resistance, whether in human medicine or in agriculture” [1–Sec. 2(3)(A)].

2.   A March 2003 report of the National Academy of Sciences stated that “a decrease in antimicrobial use in human medicine alone will have little effect on the current situation and substantial efforts  must be made to decrease inappropriate overuse in animals in agriculture” [1–Sec. 2(4)].

3.   Large-scale, voluntary surveys conducted in 1999, 2001 and 2006 by the USDA’s Animal Plant Health Inspection Service (APHIS) showed that “84 percent of grower-finisher swine farms, 83 percent of cattle feedlots, and 84 percent of sheep farms administered antimicrobials in the feed or water for health or growth promotion reasons, and many of the antimicrobials identified are identical or closely related to drugs used in human medicine, including tetracyclines, macrolides, Bacitracin, penicillins, and sulfonamides” [1–Sec. 2(6)(A)]; these drugs are also used to treat “serious diseases such as pneumonia, scarlet fever, rheumatic fever, venereal disease, skin infections, and even pandemics like malaria and plague, as well as bioterrorism agents like smallpox and anthrax” [1–Sec. 2(6)(B)].

4.    Clinical Infectious Diseases published a report in June 2002 recommending “that antimicrobial agents should no longer be used in agriculture in the absence of disease, but should be limited to therapy for diseased individual animals and prophylaxis when a disease is documented in a herd or flock” [1–Sec. 2(8)(B)].

5.   The October 2001 issue of the New England Journal of Medicinepublished an editorial calling for a ban on “nontherapeutic use of medically important antibiotics in animals” [1–Sec. 2(13)].

6.   According to a study by the US Geological Survey published March 2002, antibiotics were detected in 48% of the streams tested nationwide; and nearly half of those streams tested were downstream from agricultural operations. [1–Sec.2(9)]

7.   The General Accounting Office (GAO) determined in an April 1999 study that “resistant strains of 3 microorganisms that caused food-borne illness or disease in humans–Salmonella, Campylobacter, and E. coli–are linked to the use of antibiotics in animals” [1–Sec. 2(10)].

8.   Epidemiological research has shown that resistant Salmonella and Campylobacter infections are associated with increased numbers of ill patients and bloodstream infections and increased death [1–Sec. 2(11)].

9.   FDA’s National Antimicrobial Resistance Monitoring System “routinely finds that retail meat products are contaminated with bacteria resistant to antibiotics important in human medicine including the foodborne pathogens Campylobacter and Salmonella” [1–Sec. 2(12)(B)].

10.  USDA issued a fact sheet in December 2007 on the “recognized link between antimicrobial drug use in animals and the Methicillin Resistant Staphylococcus Aureas (MRSA) infections in humans” [1–Sec. 2(12)(C)].

Infection in humans is a problem of growing concern.  MRSA now accounts for more than half of all soft-tissue and skin infections in emergency rooms; moreover, MRSA-related hospitalizations increased nearly tenfold from 1996 to 2005. [4–para. 10]  The Federal Centers for Disease Control and Prevention estimated that in 2005 there were over 94,000 MRSA infections occurring in the United States and that these infections were associated with death in 18,650 cases [5–para. 2].

In 2007 Tara Smith, an assistant professor for the University of Iowa Department of Epidemiology, and graduate researchers [5–para. 23] tested 299 swine and 20 workers from two large hog farms (in Indiana and Illinois) finding “MRSA prevalence” in 49% of the swine (147 of 299) and 45% of workers (9 of 20) [6].  Scientists at the Louisiana State Agricultural Center did testing on 120 cuts of locally purchased meat finding MRSA in 4% of the pork and 1% of the beef; according to USDA, Americans eat more than 180 million pounds of meat a day. [4–para. 8]

FDA Response

So, what was FDA doing during all this time when the nontherapeutic use of antibiotics for animals was causing an increase in the amount of adulterated meat and poultry and was reducing the effectiveness of antibiotics used to treat disease in humans?  The Findings section of HR 1549 states that the FDA “modified the drug approval process for antibiotics to recognize the development of resistant bacteria as an important aspect of safety” [1–Sec. 2(17)(A)]; however, most antibiotics currently used for nontherapeutic purposes in animal production were approved before such scrutiny and the FDA has yet to establish “a schedule for reviewing those existing approvals” [1–Sec. 2(17)(B)].  Furthermore, a study by the General Accounting Office in April 2004 concluded that “critical data on antibiotic use in animals” that is needed to investigate health risks in humans is not being collected by any Federal agency [1–Sec. 2(19)(A)].

Health reporter Andrew Schneider had this to say about the failure of FDA and other government agencies to determine whether the livestock in the food supply was contaminated with MRSA and whether MRSA was being passed on to people who consume meat:  “An effective way to say there isn’t a problem is never to look” [5–para. 1].  That statement could apply to FDA’s hands-off approach in investigating the nontherapeutic use of antibiotics for animals in general. 

Finally in 2009, FDA changed its policy on antibiotics; the agency now opposes the use of antibiotics for growth promotion but still supports their use to compensate for crowded, unsanitary conditions in CAFOs (concentrated/confined animal feeding operations) [7–para. 2].  If FDA would support the disbanding of the CAFO system, it could change its position on antibiotics to call for a complete ban on nontherapeutic use; but none of this is in the agency’s plans.

FDA POLICY STATEMENT on GENETICALLY MODIFIED PLANTS

Congress never passed a law legalizing the sale of genetically modified foods nor did FDA ever issue such a regulation; if the agency had, at least the public would have had an opportunity to comment on the matter.  Instead, genetically modified (GM) foods were introduced into the marketplace in this country through a policy statement entitled, “Statement of Policy:  Foods Derived from New Plant Varieties” that was published in the Federal Register May 29, 1992. [8]

Policy statements have been defined by the Supreme Courts as “statements issued by an agency to advise the public perspectively of the manner in which the agency proposes to exercise a discretionary power” [Chrysler Corp. v. Brown, 441 US 281, 302 (1979)].  In other words, by issuing the policy statement, FDA was assuming the power to determine the legality of genetically modified plants and the extent to which they would be regulated without any input from the public.  In its policy statement on GM plants, FDA took a hands-off approach to its regulation, stating that “based on this record of safe development of new varieties of plants, FDA has not found it necessary to conduct, prior to marketing, routine safety reviews of whole foods derived from plants” [8–p. 10].  The policy statement declined to regulate GM plants as ‘food additives’ nor to determine whether the plants qualified for GRAS (generally recognized as safe) status, finding that “in most cases, the substances expected to become components of food as the result of genetic modification of a plant will be the same as or substantially similar to substances commonly found in food, such as proteins, fats and oils, and carbohydrates” [8–p. 4].

Under the Federal Food, Drug and Cosmetic Act (FFDCA), “[t]he term ‘food additive’ means any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food…” [21 USC 321(s)]. Substances becoming components of food as the result of genetic modification of a plant would be considered a food additive under this definition.  Under the FFDCA [21 USC 348(a)],

A food additive shall, with respect to any particular use or intended use of such additives, be deemed to be unsafe [adulterated…] unless -

(1) it and its use or intended use conform to the terms of an exemption which is in effect pursuant to subsection (j) of this section [this exception concerns investigational use of food additives by qualified experts that has been approved by the Secretary of Health and Human Services];

(2) there is in effect, and it and its use or intended use are in conformity with, a regulation issued under this section prescribing the conditions under which such additive can be safely used;….

Neither exception applies to GM plants.

No substance is GRAS “if such substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case as a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use…” [21 USC 321(s)].  Under this definition, GM plants were not GRAS.

FDA’s position on the question of whether to require labeling of genetically modified foods was to keep the consumer in the dark.  In the agency’s words: 

FDA believes that the new techniques [used in the development of GM plants] are extensions at the molecular level of traditional methods and will be used to achieve the same goals as pursued with traditional plant breeding.  The agency is not aware of any information showing that foods derived by these new methods differ from other foods in any meaningful or uniform 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.  For this reason, the agency does not believe that the method of development of a new plant variety [. . .] is normally material information [which would require labeling. . .] and would not usually be required to be disclosed in labeling for the food. [8–p. 14] 

To this day, the agency has refused to change its policy on labeling, continuing to keep consumers ignorant as to whether what they are purchasing is GM food.

The way FDA generally dismissed the dangers of GM plants to the public health in its policy statement, it would appear that the agency had a consensus of a majority of its scientists that GM plants did not generally present a risk to the public health; it did not.  Internal agency documents made public years after the 1992 policy statement show that a majority of scientists at FDA who worked on the issue were against the policy statement and believed that GM plants were more risky than traditional plants.

One FDA scientist who opposed the agency’s policy statement was microbiologist, Louis Pribyl.  According to Pribyl, “There is a profound difference between the types of unexpected effects from traditional breeding and genetic engineering” [9a–p. 132].  Pribyl warned, “There is no certainty that [the breeders of GM foods] will be able to pick up effects [e.g., the creation of toxins in the plant] that might not be obvious” [9a–p. 132, second brackets mine].  Pribyl attacked the credibility of the policy statement:  “What has happened to the scientific elements of this document?  Without a sound scientific base to rest on, this becomes a broad, general, ‘What do I have to do to avoid trouble’-type document . . . . It will look like and probably be just a political document . . . . It reads very pro-industry, especially in the area of unintended effects, but contains very little input from consumers and only a few answers for their concerns” [9a—pp.133-134, ellipses in original].

Gerald Guest, the director of FDA’s Center for Veterinary Medicine (CVM), wrote that there is “ample scientific justification” [9b–p. 133] to require testing and review of each GM food before it is marketed to the public.  “CVM believes that animal feeds derived from genetically modified plants present unique animal and food safety concerns [. . .] residues of plant constituents or toxicants in meat and milk products may pose human food safety concerns [. . . .] I would urge [FDA] to eliminate statements that suggest that the lack of information can be used as evidence for no regulatory concern” [9b–133, all brackets mine].

CVM was not the only division in FDA worried about the lack of testing done on genetically modified plants at the time the policy statement was published.  The Division of Food Chemistry and Technology warned that there were four potential dangers with GM foods [9c–p. 133]:

  1. Increased levels of known naturally occurring toxins;
  2. “Appearance of new, not previously identified” toxins;
  3. Increased likelihood that the plants will take in “toxic substances from the environment, e.g., “pesticides or heavy metals”; and
  4. Undesirable alterations in the levels of nutrients.

The division concluded by stating, “Unless genetically engineered plants are evaluated specifically for these changes, these four changes may escape breeders’ attention.”  It was the division’s recommendation that every GM food be tested “before it enters the marketplace.” [9c—p. 133]

A member of FDA’s Toxicology Group stated that genetically modified plants could contain unexpected high levels of plant toxicants [9d–p. 132].  The director of the Toxicology Group wrote, “The possibility of unexpected accidental changes in genetically engineered plants justifies a limited traditional toxicological study” [9e–p. 132].  To the detriment of the public, politics won out over science in the drafting of the policy statement.  The concerns of the FDA scientists were buried by the agency.

What has happened with GM foods since the FDA’s policy statement of 1992? Here are some of the developments:

  • A small number of companies now own the majority of planet’s commercial seeds and patented seeds.  Big business has bought up small seed companies, eliminating the companies’ seed stock and replacing it with patented brands.  Monsanto has had farmers sign contracts agreeing not to save their seeds. [10–#18]
  • ‘Genetic pollution’, that is, GM pollen drift has caused the contamination of farms that were not growing genetically modified plants.  A report from the National Academy of Science stated, “the containment of crop genes is not considered to be feasible when seeds are grown and distributed on a commercial scale” [10–#29].  Monsanto has sued farmers for theft of its intellectual property when the company’s GM seeds have drifted onto the property of farmers who have grown only conventional crops.
  • Most genetically-modified agricultural products are designed for the plant to have increased chemical resistance “developed specifically for toxin-resistance” [10–#16], requiring the use of higher doses of herbicides and pesticides.  A majority of the GM seeds are being designed to require use of herbicides to activate their growth.  These same plants also require the use of pesticides to protect them; thus farmers cultivating GM plants are forced to use increasing amounts of herbicides and pesticides on their fields.
  • The splicing of foreign material into a plant continues to be neither exact nor controlled.  In the process of genetically engineering plants, “DNA fragments are blasted passed the cell’s membrane with a gene gun shooting in foreign genetic materials in a random, unpredictable way” [10–#31].  This can result in material other than what was intended finding its way into the plant and can lead to unintended consequences that have an adverse effect on the plant.  Richard Lacey, a medical microbiologist, has stated, “wedging foreign genetic material in an essentially random manner . . . causes some degree of disruption . . . . It is impossible to predict what problems could result” [10–#31].
  • FDA has adopted a policy on genetically engineered livestock similar to its policy on genetically modified plants.  In 2008, the agency issued a risk assessment on animal cloning that “evaluated the health effects to animals involved in the process of cloning and evaluated the food consumption risk that may result from edible products derived from animal clones or their progeny” [11–p. 2]  FDA concluded that “meat and milk from clones of cattle, swine and goats, and the offspring of clones from any species traditionally consumed as food, are as safe to eat as food from conventionally bred animals” [11–p. 2].  Similar to its policy on genetically modified plants, FDA has imposed no labeling requirement informing consumers that are buying meat from cloned cattle, swine or goat.
  • An increasing number of scientific studies have found harmful health effects associated with the consumption of genetically modified food.  The latest study is a research paper published in the International Journal of Biological Sciencesthat involved “a comparative analysis of blood and organ system data from trials with rats fed three main commercialized genetically modified (GM) maize (NK 603, MON 810, MON 863), which are present in food and feed in the world” [12–p. 706 Abstract].  The conclusion of the scientists doing the study was that their

    • analysis clearly reveals for the 3 GMOs new side effects linked with GM maize consumption, which were sex- and often dose-dependent.  Effects were mostly associated with the kidney and liver, the dietary detoxifying organs, although different between the 3 GMOs.  Other effects were also noticed in the heart, adrenal glands, spleen and haematopoietic system.  We conclude that these data highlight signs of hepatorenal toxicity, possibly due to the new pesticides specific to each GM corn.  In addition, unintended direct or indirect metabolic consequences of the genetic modification cannot be excluded. [12—p. 706 Abstract]

  • Referred to as “terminator technology”, plants are being genetically engineered so that they do not produce usable seeds, forcing farmers to use purchased seeds for every planting [10–#37].
  • Another term, “traitor technology”, refers technology that controls the life cycle of plants, e.g., when a plant will leaf, flower and bear fruit.  The farmer is forced to use certain triggering chemicals if there is to be a harvest, further increasing the farm’s expenses. [10–#38]
  • In spite of the growing number of reports about the adverse effects of GM foods, FDA has maintained its policy of not overseeing health safety testing of GM foods by those corporations marketing the foods [10–#2].  Corporations can design the tests done with GM products to ensure they get the results they want.  FDA has not taken on the responsibility to regulate the safety of these products.  The agency’s primary concern has been to promote the growth of the biotech industry.
  • One of the selling points claimed by the biotechnology industry is that increased yields of GM crops will solve the world’s hunger problems.  Studies done by organizations such as the Union of Concerned Scientists [13] have found that the overall aggregate yield of GM crops is not significantly different than that of traditional crops.

FDA permitted the marketing of GM foods when very little testing had been done to validate their safety.  In allowing the sale of GM foods, the agency unleashed an uncontrolled experiment on the planet.  GM products today are blamed by many for environmental destruction, the decline in human and animal health, and the loss of political and economic freedom.

CONCERNS About FOOD SAFETY LEGISLATION

Besides FDA’s track record of favoring the pharmaceutical and biotech industries, there is other evidence that the agency would not enforce any food safety bill passed by Congress in a way that is in the best interest of the American people.  The biggest cause of foodborne illness in this country is imported food; yet, in testimony on S. 510 (the Senate food safety bill) before the Senate Committee on Health, Education, Labor and Pensions, FDA Commissioner Margaret Hamburg stated that “the bill’s  foreign inspection mandate may not result in the best use of FDA’s resources” [14–p. 6].  Hamburg indicated that the agency would rather have accredited third-party inspectors or foreign governments being responsible for inspections [14–p. 5]; this raises the question of whether foreign governments or third-party inspectors would act in the best interest of the United States when to do so could mean costing its own countrymen the loss of markets in this country.  Hamburg made similar statements in her June 3, 2009 testimony before the House Energy and Commerce Committee’s Subcommittee on Health when it was considering HR 2749 [15].  FDA intends to use most of its resources on domestic enforcement.

In the past, FDA has not respected consumer freedom of choice in areas such as nutritional supplements, alternative health treatments (particularly for cancer), and consumption of raw milk and raw milk products.  If the food safety bill passes, the degree of access that consumers currently enjoy to foods produced by small farmers and local artisanal producers will be threatened.  There is little money in the local food movement for pharmaceutical and biotechnology industries.  The continued growth of the local food movement will cause the profits of the two industries to decline.   With passage of any current food safety bill, FDA would be in a better position to reverse that trend.  The likelihood is that the agency would use a disproportionately high amount of its resources to enforce the new law against suppliers of the local food movement.  With its added power to regulate produce under either HR 2749 or S. 510, will the agency issue a regulation establishing the use of genetically engineered seed as a good agricultural practice (GAP)?  There is no evidence that FDA will use its increased power to do anything to help small sustainable farms. For more details on HR 2749, go to http://www.farmtoconsumer.org/news/news-15june2009.htm

The full Senate will likely vote on S. 510 sometime next month; click here for the status of S. 510 or go to www.thomas.gov and type "S 510″ in the search (be sure to select "Bill number").  Now is the time to call your senators and inform them that you oppose S. 510 and any food safety bill that regulates small farmers and local artisanal producers any more than they are currently under federal law. 

Contact information for your Senators can be found at: http://www.opencongress.org/people/senators

Referenced Sources:

1.  HR 1549 as introduced in the U.S. House of Representatives on March 17, 2009, entitled “Preservation of Antibiotics for Medical Treatment Act of 2009″.  Click here to view status of HR 1549 or go to www.thomas.gov and type “HR1549″ in the search (be sure to select “Bill number”).

2. Kammerle Schneider and Laurie Garrett,  “Non-therapeutic Use of Antibiotics in Animal Agriculture, Corresponding Resistance Rates, and What Can be Done About It“, 19 June 2009, Center for Global Development June 2009 Newsletter, viewed 6 Jan. 2010 [http://www.cgdev.org/content/article/detail/1422307]

3.  “The Basics: Antibiotic Overuse in Animals,”  The Campaign to End Antibiotic Overuse, 4 December 2003, Keep Antibiotics Working, viewed 29 Dec. 2009 [http://www.keepantibioticsworking.com/new/basics_overuse.cfm]

4.  Stephanie Woodard,  “The Superbug in Your Supermarket,”  Prevention 20 June 2009, viewed 9 Jan. 2010 [http://www.prevention.com/health/nutrition/smart-shopping/the-superbug-in-your-supermarket/article/9b99ce1071ff1210VgnVCM10000030281eac____ ]

5.  Andrew Schneider, “First study finds MRSA in U.S. pigs and farmers; U.K reports 3 patients sickened with the bacterium from eating pork only,”  4 June 2008, Seattle PI Blog “Secret Ingredient,” viewed 12 Jan. 2010 [http://blog.seattlepi.com/secretingredients/archives/140336.asp] 

6.  TC Smith, MJ Male, AL Harper, JS Kroeger, GP Tinkler, ED Moritz, AW Capuano, LHA Herwaldt, DJ Diekema, “Methicillin-Resistant Staphylocococcus aureus (MRSA) Strain ST398 Is Present in Midwestern U.S. Swine and Swine Workers,” 23 January 2008,  PubMed U.S. National Library of Medicine, National Institutes of Health (PMID: 19145257), viewed 13 Jan. 2010 [http://www.ncbi.nlm.nih.gov/pubmed/19145257]. 

     Click here for PDF of published research article, accessible online atwww.plosone.org (”accelerating the publication of peer-reviewed science”): 

      PLoS ONE 4(1): e4258. doi:10.1371/journal.pone.0004258, viewed 27 Jan 2010 [http://www.plosone.org/article/info:doi%2F10.1371%2Fjournal.pone.0004258] 

7. Laura Rogers, qtd. In Lisa Cutler, “PEW Calls FDA Testimony on Use of Antibiotics on Industrial Farms a Key First Step, More Is Needed,” 13 July 2009 press release by the PEW Charitable Trusts in response to testimony 13 July 2009 by Dr. Joshua Sharfstein before the U.S. House Committee on Rules, viewed 13 Jan. 2010 [http://www.saveantibiotics.org/newsroom/pr_13july2009.html]

     Testimony of Dr. Joshua Sharfstein is posted on the FDA website athttp://www.fda.gov/NewsEvents/Testimony/ucm171715.htm

8. Food and Drug Administration, HHS; Federal Register, “Statement of Policy: Foods Derived From New Plant Varieties,” 29 May 1992 (57 FR 22984) obtained from Westlaw Thomson Reuters, viewed 1 Dec. 2009.  Click here for pdf of 57 FR 22984.

9. Jeffrey M. Smith, Chapter 5 “Government by the Industry for the Industry,”Seeds of Deception (Fairfield, Iowa: Yes! Books 2003).  Note:  many of the documents referenced can be found and printed athttp://www.biointegrity.org/list.html

    a. Louis Pribly qtd. in [9] from Pribyl in a letter to James Maryanski, the FDA’s biotech coordinator.

    b. Gerald Guest qtd. in [9], Gerald B. Guest to James Maryanski, “Regulation of Trasngenic Plants—FDA Draft Federal Register Notice on Food Biotechnology,”5 February 1992, www.biointegrity.org  

    c. qtd. in [9], Division of Food Chemistry and Technology and Division of Contaminatnts Chemistry, “Points to Consider for Safety Evaluation of Genetically Modified Foods: Supplemental Information,” 1 November 1991,www.biointegrity.com

    d. qtd. in [9], Edwin J. Mathews to the Toxicology Section of the Biotechnology Working Group, “Analysis of the Major Plant Toxicants,” 28 October 1991,www.biointegrity.com 

    e. qtd. in [9], Samuel I. Shibko to James Maryanski, “Revisions of Toxicology Section of the Statement of Policy: Foods Derived from Genetically Modified Plants,” 31 January 1992, www.biointegrity.com

10. Nathan Batalion, “50 Harmful Effects of Genetically Modified (GM) Foods,” updated 2008, Raw-Wisdom.com [http://www.raw-wisdom.com/50harmful.], qtd. entirely by PakAlert 10 May 2009, viewed 9 Jan. 2010 [http://pakalert.wordpress.com/2009/05/10/50-harmful-effects-of-genetically-modified-gm-foods/]

      Click here for pdf version derived from PakAlert.

11. Food and Drug Administration, HHS; Federal Register, “Animal Cloning Risk Assessment; Risk Management Plan; Guidance for Industry; Availability,” 16 January 2008 ( 73 FR 2923) obtained from Westlaw Thomson Reuters, viewed 6 Jan. 2010.  Click here for pdf of 73 FR 2923.

12. Joel Spiroux de Vendômois, François Roullier F, Dominique Cellier, Gilles-Eric Séralini GE, “A Comparison of the Effects of Three GM Corn Varieties on Mammalian Health,” International Journal of Biological Sciences 2009, 5(7):706-726, viewed 14 Jan. 2010 [http://www.biolsci.org/v05p0706.htm] 

13. Doug Gurian-Sherman, “Failure to Yield: Evaluating the Performance of Genetically Engineered Crops,” April 2009, Union of Concerned Scientists, viewed Jan. 2010 [www.ucsusa.org]

14. Margaret A. Hamburg (Commissioner of Food and Drugs, FDA, HHS), “Keeping America’s Families Safe: Reforming the Food Safety System,” Testimony before U.S. Senate Committee on Health, Education, Labor and Pensions 22 October 2009, viewed Jan. 2010.  Click here for pdf of 10/22/09 testimony.

15. Margaret A. Hamburg (Commissioner of Food and Drugs, FDA, HHS), “The Urgent Need for Reform of Our Nation’s Food Safety System,” Testimony before U.S. House Committee on Energy and Commerce Subcommittee on Health 3 June 2009, viewed Jan. 2010.  Click here for pdf of 6/3/09 testimony.

Last edited 02/02/2010