* Assistant Professor of Law, Barry University of Orlando School of Law; J.D., Rutgers University School of Law, Newark (1994); Ph.D. (Organic Chemistry), Rutgers University, Newark (1988). Many thanks to my husband Dr. Harry Behzadi, a fellow scientist, for his scientific research and assistance. Much appreciation to Professor Pam Armstrong, Dean Stan Talcott, Johanna Talcott, and Margaret Satterfield for their contributions.
Several comments in this paper are opinions stemming from the author’s scientific background and should only be construed as such.
1 See generally Norine Dworkin, 22 Reasons to Go Vegetarian Right Now: Benefits of Vegetarian Diet, VEGETARIAN TIMES, Apr. 1, 1999, at 90.
2 Hormones which are administered for the purpose of increasing growth are given in the form of pelleted hormone implants that dissipate over time. These implants are injected under the skin on the back side of the ear. The ears are then removed when the animal is slaughtered. The ears are not sold as food material for human use. See Jan R. Busboom & Karen P. Penner, Hormones and Meat (visited Mar. 4, 2000) <http:// www.inform.umd.edu/EdRes/Topic/AgrEnv/ndd/safefood/HORMONES_AND_MEAT.html>.
3 See id.
4 See id.
5 Xenoestrogens refer to other environmental compounds that generally have very potent estrogen-like activity and thus can be considered very toxic. See JOHN R. LEE, M.D. & VIRGINIA HOPKINS, What Your Doctor May Not Tell You About Menopause 41 (1996).
6 See 21 U.S.C. § 348(c)(3)(A) (West 2000).
7 See Sam Tucker, World Wildlife Fund Canada’s Guide to Hormone Disruptors, BOSTON REV., Sept. 9-15, 1996, available at <http://www.webactive.com/webactive/features/wwf can.htm>.
8 See id.
9 See id. The endocrine system is the manner by which hormones are used and distributed by the human body.
10 See Food & Drug Administration; Statement of Organization, Functions, and Delegations of Authority, 49 Fed. Reg. 10,166, 10,167 (1984); see also U.S. Food & Drug Administration, A Historical Perspective of CVM (last modified Sept. 30, 1999) <http://www.fda. gov/cvm/fda/ aboutcvm/beginningstxt.html>.
11 See 49 Fed. Reg. at 10,175. The new animal drug must be approved on the basis of quality, safety, and efficacy. With respect to safety, although safety to the animal is important, safety of all food products derived from treated animals that are intended for human consumption must also be demonstrated. See id.
12 See 21 C.F.R. §§ 360(b), 514.106 (West 2000). Section 360(b) of the FFDCA requires the FDA to take an appropriate action within 180 days of filing of an NADA. The outline depicting the organization and content of an NADA is governed by 21 C.F.R. section 514.106. See id. § 514.106.
13 See Center for Veterinary Medicine, Program Policy and Procedures Manual, Guide 1240.3010: Processing Original Investigational New Animal Drug Applications (last modified May 14, 1998) <http://www.fda.gov/cvm/fda/aboutcvm/3010.pdf> [hereinafter Processing Original Investigational New Animal Drug Applications].
14 See id. Even after the initial review is concluded, team leaders once again check all material for additional assessment. The Division Director then reviews and evaluates the conclusions of both the reviewers and the team leaders. See id.; see also Center for Veterinary Medicine, Program Policy and Procedures Manual, Guide 1240.3100: General Review and Enforcement Policies, Initial Processing of an NADA (last modified May 14, 1998) <http://www.fda.gov/cvm/fda/aboutcvm/3100.pdf> (providing further information out-lining the steps of processing an NADA).
15 See Processing Original Investigational New Animal Drug Applications, supra note 13.
16 See id.
17 See Patti Goldman & J. Martin Wagner, World Trade Organization Dispute Settlement Proceeding European Communities—Measures Concerning Meat and Meat Products (Hormones) (visited Oct. 4, 1996) <http://www.citizen.org/pctrade/gattwto/Cases&Tribunalists/beef. html>. Three of the hormones, estradiol-17, progesterone, and testosterone are naturally occurring hormones. The other three, trenbolone acetate, zeranol, and melengestrol acetate (MGA), are synthetic. All the hormones, except for MGA, are administered in the form of pellets implanted in the ears of the animals. MGA is approved for administration directly in cattle feed. See id.
18 See Food & Drug Administration Center for Veterinary Medicine, The Use of Hormones for Growth Promotion in Food-Producing Animals (May 1996) <http://www.fda.gov/cvm/fad/ infores/ hormones.html> [hereinafter Use of Hormones].
19 See id.
20 See id. The argument in favor of safety is that the amount of the added hormone is negligible compared to the consumer’s own daily production rate. See id. However, more scientific research is needed to determine whether even levels considered scientifically “negligible” may have an endocrine disrupting effect not only on the endocrine system, but on the human system as a whole.
21 Letter from Ronnie Cummins, Campaign for Food Safety, to Pure-food-action@mr.net (June 4, 1999) (on file with author). The EU’s Scientific Committee on Veterinary Measures told the Associated Press that the hormone 17 beta-oestradiol “has to be considered as a complete carcinogen.” Id. In addition, the panel stated that all the banned hormones had the capability of causing a host of health problems, even at the small levels found in meat residues. See id.
22 See Use of Hormones, supra note 18. These hormones are essential for the proper physiological functioning of human body systems. See id.
23 See id. The scientific studies allegedly detail that the concentrations derived from these meats remain within the normal physiological range that has been established for like untreated animals of the same age and sex. See id.
24 See id. The manufacturers are required to prove that the hormone residues are below this safety level. See id.
25 See 21 C.F.R. § 522.1940 (1997); see also Dale E. McNiel, The First Case Under The WTO’s Sanitary And Phytosanitary Agreement: The European Union’s Hormone Ban, 39 Va. J. Int’l L. 89, 99 (1998).
26 See 21 C.F.R. § 558.342; see also McNiel, supra note 25, at 99.
27 See Associated Press, EU Won’t Bend on Beef, Deseret News, Oct. 5, 1999, at E4. The World Trade Organization (WTO) has stated that the ban is illegal and is not supported by proper scientific risk analysis. The EU disagrees and continues to contend that hormone-laden meat poses health risks to consumers and that at least one of the hormones in dispute has a probability of causing cancer. The FDA and other U.S. governmental entities dispute these findings. See id.
The EU is particularly concerned with the fact that 17 beta-estradiol, which they found to exert both tumor-initiating and tumor-promoting effects, as well as the other hormones used in implants, are freely available over-the-counter in the United States. See Barry James, Battle to Prove Beef Hormone Risk; Behind Contested EU Ban, a Scientific Puzzle, Int’l Herald Trib., Oct. 18, 1999, at 13. The EU is concerned with the lack of supervision involved in administering these hormones. Because the EU alleges there are no U.S. controls in place, a misplaced hormone implant can enter the food supply with a high risk of hormone contamination. See id.
28 See id.
29 See Laura Eggertson, Meat Checks Deficient, EU Argues, Toronto Star, Oct. 27, 1999, available at <http://www.thestar.com/back_issues/index.html>. In a news release, the EU stated that:
[h]uman exposure and risk are in particular increased by the fact that regulatory controls over residues of hormones in meat placed on the market are deficient in the U.S.A. and are insufficient in Canada. There is a clear potential for adverse effects on human health arising especially from the presence of residues of these hormones.
Id.
30 See id.
31 See id. In addition, a Dispute Settlement Panel of the WTO held that the European ban on meat from animals treated with certain growth hormones violated international trading rules. This was not the first conflict of environmental and health concerns and trading rules. Three sets of rules usually apply with respect to the environment and health: (1) GATT 1994 Articles XX (b), (d), and (g), which provide exceptions to other GATT articles; (2) the Agreement on the Application of Sanitary and Phytosanitary Measures, otherwise known as the SPS Agreement; and (3) the Agreement on Technical Barriers to Trade. For purposes of this article, number (2) is the most relevant, as the Settlement Panel determined that: “[b]y maintaining sanitary measures that do not rest on a scientific ‘risk assessment,’ the EC has acted inconsistently with Article 5.1 of the SPS Agreement.” See John R. Schmertz & Mike Meier, WTO Panel Decision Holds that European Communities’ Ban on Meat From Animals Treated with Growth Hormones Violated International Trading Rules, 3 Int’l L. Update 120, 120-21 (1997). See also David A. Wirth, European Communities Restrictions on Imports of Beef Treated With Hormones—NonTariff Trade Barriers—Control of Food Additives—Scientific Basis For Restrictions—WTO Dispute Settlement Mechanisms—Scope of Review, 92 Am. J. Int’l L. 755, 755-56 (1998). “For more than a decade, the United States, where use of the same hormones is permitted for these purposes, has objected to the EC hormone ban as a NonTariff barrier to trade unsupported by scientific evidence.” Wirth, supra, at 755-56 (emphasis added).
32 See Charles E. Hanrahan, Congressional Research Service, The European Union’s Ban on Hormone-Treated Meat (Feb. 8, 1996) <http://www.cnie.org/nle/ag-15.html>.
33 See Wirth, supra note 31, at 759. The U.S. cattle exporters should have expressed a desire to settle the scientific uncertainty regarding the potential hazards of meat laden with hormones. If exporters are to stand behind their contention that the hormones pose no danger, then they should not only express enthusiasm at research that would resolve the issue, but should in fact lend financial assistance to assist in the expediency and availability of such research. See id.
34 See EU Agrees on Meat Standards, Food Ingredient News (Bus. Communications Co.), Aug. 1999. In fact, it is the United States which has just recently voluntarily suspended shipments of “hormone-free” meat to the EU as a result of concern that U.S. meat suppliers were not delivering what was agreed upon. In the Spring of 1999, the EU discovered that twelve percent of the beef labeled as hormone-free contained hormone residues. See id.
35 See id.
36 See Meat Industry Insights News Service, U.S. Accuses EU of “Misleading” Hormone Report (May 4, 1999) <http://www.lihq.net/spc/mii/990530.htm>.
37 See id. The EU report states that excess intakes of the six growth hormones used in cattle production could have an adverse effect on consumer health. In addition, the EU continues to state that one of the hormones, 17 beta-oestradiol, may have a propensity to cause cancer. Both Secretary Glickman and Trade Representative Barshefsky believe the EU report is but a ploy and is a deliberate attempt to ignore scientific data which they believe has proven that these hormones do not pose a risk to human or animal health. See id.
38 See Ronnie Cummins & Ben Lilliston, Beef Hormones, Irradiation, & Mad Deer: America’s Food Safety Crisis Continues, Center for Food Safety News #19 (formerly Food Bytes), June 4, 1999, at 1. The EU’s Scientific Committee on Veterinary Measures spoke to the Associated Press and stated “the hormone 17 beta-oestradiol has to be considered as a complete carcinogen”. Id.
39 See id.
40 See id.
41 See Busboom & Penner, supra note 2. The FDA, in studying the effects of hormone residues on human health, determined that if consumers eat meat which contains one percent or less of the amount of hormone their own bodies produce, no ill effect should be expected. See id. (table comparing estrogen in meat and estrogen produced daily by humans).
42 See Goldman & Wagner, supra note 17.
43 See id.
44 See id. The elevated levels of estrogen were found to have been a result of the consumption of meat products which contained elevated amounts of estrogen. See id.
45 See id.
46 See id.
47 See Goldman & Wagner, supra note 17. DES was known to cause cancer since 1938. It continued to be used as a growth promoter in livestock, as well as a treatment to prevent miscarriage in pregnant women, until the late 1970s. The detrimental effects on women and their female offspring who ingested this hormone became apparent in the 1960s, when the daughters of women treated with DES started to develop a rare form of vaginal cancer. The United States eventually banned the hormone in 1978.
48 See European Commission, Directorate-General XXIV, Opinion of the Scientific Committee on Veterinary Measures Relating to Public Health, Assessment of Potential Risks to Human Health from Hormone Residues in Bovine Meat and Meat Products, at 1 (Apr. 30, 1999) [hereinafter E.C. Report]; see also European Commission, Growth Hormones in Meat Pose Risk to Consumers–Different Levels of Evidence (May 3, 1999) <http://europa.eu. int/comm/trade/mitr/dispute/hormones/hor0405a.htm>. 17 beta-oestradiol, progesterone, and testosterone are natural hormones. Zeronol, trenbolone, and melengestrol acetate are synthetic products. See id.
49 See E.C. Report, supra note 48, at 3.
50 See id. at 2. The E.C. Report states, in pertinent part, as follows:
[i]t has become evident that equally responsible and representative governments may act in good faith on the basis of what, at a given time, may be a divergent opinion coming from qualified and respected sources. This implies that risk to be evaluated is not only risk ascertainable in a laboratory operating under strictly controlled conditions, but also risk in human societies as they actually exist, in other words the actual potential for adverse effects in human health in the real world where people live and work and die.
Id.
51 The report utilizes the word “oestrogens” to represent compounds of differing chemical structure, which are able to induce histological changes in the vagina and uterus during the estrous (fertile) period. See id. at 5-10.
52 See id. at 16.
53 See id. at 17; see also Dworkin, supra note 1, at 3. There are, of course, other possibilities for the association between high meat consumption and the increased rate of breast cancer. Other reasons, such as the fat intake from meat may be a factor. However, the association is sufficiently compelling to justify further studies.
54 It is beyond the scope of this article to present all the scientific findings of the E.C. Report. It suffices to state that the study found positive correlations regarding consumption of hormone-treated meat and illness or hormonal imbalances in humans. See E.C. Report, supra note 48, at 16, 17.
55 See id. at 19. Consumers tend to believe that the term “natural” also means “safe.” See Leticia M. Diaz, First St. John’s Wort, Now SAM-e: The FDA’s Responsibility in Psychiatric Self-Medication: Is Society as a Whole at Risk Without FDA Regulation?, 9 Kan. J.L. & Pub. Pol’y 283, 285 & n.56 (1999).
56 See E.C. Report, supra note 48, at 21; Cynthia F. Brogdon, Women and Cancer, 21(6) J. of I.V. Nursing 344, 348 (1998). Early onset of menarche is a well established risk factor for developing breast cancer.
57 The hormone levels presented in the study were determined by radio-immunoassays (RIAS). These assays have been associated with the production of variable results. The study therefore recommends further experimentation in this area. See E.C. Report, supra note 48, at 29, 30, 32.
58 See id. at 72-73.
59 Monitoring for hormone residues is done by the Food Safety and Inspection Service and the U.S. Department of Agriculture. Violations are determined by tolerance levels set by the FDA. No monitoring is performed for naturally occurring hormones, based on the FDA’s conclusion that the increased exposure to the hormones is far below concentrations considered to be unsafe. See Karen P. Penner, Hormones and Meat: Food and Nutrition—The Link Between Agriculture and Health (visited Mar. 4, 2000) <http://www.foodsafety.org/sf/sf 083.htm>.
60 See generally Samuel S. Epstein, The Chemical Jungle: Today’s Beef Industry, 20 Int’l J. Health Serv. 278 (1990).
61 There is evidence that even exceedingly low levels of industrial chemicals can cause damage through an additive effect. Dr. Ana Soto at Tufts University combined ten hormone disruptors, each at one-tenth of the dose which would be required to produce a minimal response. The results of the experiment indicated that the combination of minute quantities of the chemicals produced a response. See generally Theo Colborn, Our Stolen Future (1997); Our Stolen Future, Part 3: Flying Blind, Rachel’s Env’t & Health Weekly No. 490 (Apr. 19, 1996).
62 See EU Proposes Ban of U.S. Meat and Poultry (visited Oct. 15, 1999) <http:// hill.beef.org/ft/eupbusm.htm>. Weber claims that the ban is a political move to protect the European meat industry. See id.
63 See id.
64 See Meat Industry Insights News Service, U.S. Says EU Beef Ban Could Damage WTO (Mar. 13, 1998) <http://www.pb.net/spc/mii/980329.htm>.
65 See Food Chem. News (Food Chem. News, Inc., Wash., D.C.), June 21, 1999, at 1.
66 See id.
67 See id. One of the FDA’s main arguments is that the European Commission has ignored epidemiological studies performed on women which indicated that estradiol is not genotoxic. See id.
68 See Barry James, Trade War Looms Over Hormone Beef Ban as EU Reiterates Health Fears, Int’l Herald Trib., May 13, 1999, at 5.
69 See id. (“U.S. impatience on the issue has been 10 years in the making and time has run out”).
70 Id. The operative word may be “essentially.” Consumers have the right to choose not to take the chance on “essentially no safety difference,” and instead to opt for hormone-free meat, which would eliminate even so-called negligible risks.
71 See id.
72 See id. About ninety percent of U.S. beef cattle is treated with hormone implants. It is mathematically obvious why the NCBA is suffering such pecuniary losses. See id.
73 See James, supra note 68, at 5.
74 See id.
75 See id.
76 See id. (for example, Dr. Skakkebaek states that “[s]mall boys produce very low quantities or perhaps even none of the female sex hormone, and that means they could receive from treated meat quantities of estrogen perhaps hundreds of times in excess of the amount suggested by U.S. guidelines”).
77 See id. Dr. Skakkebaek balks at the U.S. data espousing the safety of hormone residues in meat. He feels that the studies are unreliable because they were developed almost two decades ago. He also rebuts Washington’s assertion that hormone residues pose no health hazard, as he claims there have been almost no concrete studies on the extent to which synthetic hormones are absorbed by the human body. See id.
78 See James, supra note 68, at 5.
79 See generally Donna U. Vogt, The Delaney Clause Effects on Pesticide Policy, Congressional Research Service, Report for Congress, July 13, 1995.
80 See id. The Delaney Clause is codified in the Federal Food, Drug, & Cosmetic Act. See 21 U.S.C. §§ 348, 409(c)(3)(A), 706(b)(5)(B), 512(d)(1)(H) (West 2000). Section 348 states that: “[n]o additive shall be deemed to be safe if it is found to induce cancer when ingested by man or animal, or if it is found, after tests which are appropriate for the evaluation of the safety of food additives, to induce cancer in man or animal.” Id. § 348.
81 See generally Vogt, supra note 79.
82 See Food Additives: Hearings Before a Subcommittee of the House Committee on Interstate and Foreign Commerce, 85th Cong., 1st & 2nd Sessions 171 (1958); Andrew J. Miller, Note, The Food Quality Protection Act of 1996; Science and Law at a Crossroads, 7 Duke Envtl. L. & Pol’y F. 393, 395 (1997).
83 See Miller, supra note 82, at 395-96.
84 See 7 U.S.C. § 136 (1999).
85 See 21 U.S.C. §§ 301-395 (West 2000).
86 See 7 U.S.C. § 136a.
87 The registration application must contain a statement of claims about the pesticide’s proposed use, the data upon which the claims are based, the pesticide’s chemical formula, and a request for classification. See id. § 136a(c)(1).
88 Id. § 136a(c)(5)(C).
89 See generally Vogt, supra note 79.
90 See id.
91 See 21 U.S.C. § 346(a) (West 2000).
92 See id. § 342(a).
93 Id. § 346.
94 See id. § 348.
95 See id. § 342(a). It was not necessary for all pesticide residues in processed foods to be assigned tolerances under section 409. Under the FFDCA’s “flow-through” provision, if a residue was from a pesticide which was applied prior to processing, there was no need for a section 409 tolerance. See id.
96 See 21 U.S.C. § 342(a).
97 See id. § 348(c)(3)(A).
98 See id. The Clause reads in part “no additive shall be deemed to be safe if it is found to induce cancer when ingested by man or animal, or if it is found, after tests which are appropriate for the evaluation of the safety of food additives, to induce cancer in man or animal.” Id.
99 Under the EPA’s coordination policy, the Agency would not grant a section 408 raw food tolerance if the pesticide residue failed section 409’s zero-tolerance test. See Pesticides; Request for Comment on Petition to Modify EPA Policy on Pesticide Tolerances, 58 Fed. Reg. 7470, 7473 (1993); Pesticide Tolerances; Proposed Revocations, 61 Fed. Reg. 8174, 8174 (1996). The public policy reasoning was probably to avoid massive confusion in the market. Agricultural workers would not know whether a pesticide would be allowed unless they knew to a certain specificity if their crops would be sold as a raw commodity or in a processed food.
100 See Section 409 Tolerances; Response to Petition Requesting Revocation of Food Additive Regulations, 55 Fed. Reg. 17,560, 17,562 (1990). For an excellent review of the Delaney conflict or paradox, see Edward Dunkelberger & Richard A. Merrill, The Delaney Paradox Reexamined: Regulating Pesticides in Processed Foods, 48 Food & Drug L.J. 411, 430–38 (1993).
101 See id. at 411.
102 See Uniform Standards Recommended to Reduce Potential Cancer Risk From Pesticide Residues, The Nat’l Acad. News (The Nat’l Acad., Wash., D.C.), May 20, 1987, at 3.
103 See id. at 1.
104 See id.
105 See Regulation of Pesticides in Food: Addressing the Delaney Paradox Policy Statement, 53 Fed. Reg. 41,104, 41,110 (1988).
106 See 968 F.2d 985, 988–89 (9th Cir. 1992). The court made it clear that, under the Delaney Clause, the EPA had no discretion to allow the use of any food additives, including pesticides that were known to be carcinogenic in nature. See id. at 988. It felt that the legislative history was clear and left no room for interpretation. See id. The EPA, in turn, argued that a de minimis exception to the Delaney Clause was a necessity to allow for a more logical application of the regulatory scheme. The court flatly repudiated this line of reasoning. See id. at 990.
107 See Public Citizen v. Young, 831 F.2d 1108, 1123 (D.C. Cir. 1987); Les, 968 F.2d at 988-89.
108 See Food Quality Protection Act of 1996, Pub. L. No. 104–170, 110 Stat. 1489 (codified as amended in scattered sections of 7 U.S.C. and 21 U.S.C.).
109 An example is the Act’s revision of FIFRA’s reregistration process. See 7 U.S.C. §136a-1(g)(2)(E) (1999).
110 See 21 U.S.C. § 3210(s)(1) (1999).
111 See EPA Office of Pesticide Programs, Highlights of the Food Quality Protection Act of 1996 (last modified Aug. 19, 1999) <http://www.epa.gov/oppfead1/fqpa/fqpahigh. htm>.
112 Id.
113 See generally Leticia M. Diaz, Sucralose: The Sugar of the New Millennium—FDA’s Role: A Hindrance or a Help, 34 New Eng. L. Rev. 363 (2000).
114 If agencies determine that more stringent limits should not be set, then, at a minimum, an explanation of the safety of the detected residues should be made public.
115 See Committee On Agric., Nutrition & Forestry, Food Safety: Where Are We? 171 (1979).
116 See id. at 172.
117 See id.
118 Gas Chromatography is chromatography “in which the moving phase is a mixture of gases or vapors, which separate during their differential absorption by a stationary phase.” Compact Am. Med. Dictionary 183 (1998). In lay terms, this simply means that the organic compounds are able to be separated, identified, and quantified.
119 See Mark S. Lesney, From WWII to the Cold War: Through the Eye of the Atom, Analytical Chemistry, Mar. 1999, at 45; Made to Measure, A History of Analytical Instrumentation, Analytical Chemistry, Mar. 1999, at 121 [hereinafter Made to Measure].
120 See Made to Measure, supra note 119, at 121. The specific mechanisms of these type of detectors are beyond the scope of this paper. Interested parties are referred to the citation.
121 See id.
122 See id.
123 See generally Pesticides; Science Policy Issues Related to the Food Quality Protection Act, 63 Fed. Reg. 67,063 (1998); Threshold of Regulation Policy—Deciding Whether a Pesticide With a Food Use Pattern Needs a Tolerance (Oct. 18, 1999) <http://www.epa.gov/fedrgstr/ EPA-PEST/1999/October/Day-27/6042.htm> [hereinafter Threshold of Regulation Policy].
124 See id.
125 Id. The EPA would regulate pesticides that qualify under FIFRA. See id.
126 See id.
127 See generally Vogt, supra note 79.
128 See Threshold of Regulation Policy, supra note 123, at 7. The policy states that:
[r]easonably protective criteria means that incremental risk from exposure to potential residues in food resulting from use of a pesticide should generally be less than 1/1000 of the acceptable risk. The incremental potential risk from the use of a potentially carcinogenic pesticide should be below 1 x 10-9 for a pesticide that exerts threshold effects. Reasonably protective criteria means that the incremental acute or chronic potential exposure from the use occupies less than 0.1% of the acute or chronic population-adjusted dose for the pesticide. EPA will consider potential risks to the most sensitive population, including an appropriate additional safety factor for infants and children as required by the FQPA.
Id.
129 See id. at 7.
130 See id. at 2.
131 See Nutrition and Your Health: Dietary Guidelines for Americans (last modified Nov. 1990) <http://www.medscape.com/govmt/DHHS/patient/DietaryGuidelines.html>. For example, vegetables, fruits, and grain products are important parts of a varied diet according to the dietary guideline. See id.
132 DDT is the abbreviation for Dichlordiphenyltrichloroethane.
133 See generally N. Krieger et al., Breast Cancer and Serum Organochlorines: A Prospective Study Among White, Black, and Asian Women, J. Nat’l Cancer Inst. 589-99 (1994). Carcinogenic risk is estimated by the EPA as the incremental probability of an individual developing cancer over a lifetime as a result of exposure to the potential carcinogen. See generally id.
134 See generally id.
135 See Bonnie Liebman, Pesticides and Breast Cancer (Mar. 1999) <http://www.cspinet. org/nah/3_99/pesticides.htm>.
136 See id. The study was conducted on 7,712 healthy Danish women in the Copenhagen City Heart Study. Researchers found a direct link among women exposed to high levels of Dieldrin to the development of breast carcinoma. Dieldrin was used on apples and other types of food crops up until the late 1970s. It was used for termite control until 1985. It was determined that more detailed analyses of Dieldrin levels in the United States, where blood levels are lower than in Denmark, should be performed to assess the risk involved. See id.
137 See EPA Office of Prevention, Pesticides, and Toxic Substances, Background on Endocrine Disruptors (Sept. 24, 1997) <http://www.epa.gov/scipoly/oscpendo/backgrnd.htm>.
138 See id.
139 See id.
140 See id. The endocrine system consists of a set of glands which produce hormones. These hormones are responsible for the development, growth, reproduction, and behavior of human and animal systems. Hormones are chemicals, produced by these glands, that travel through the bloodstream and are responsible for many biological responses in our body. Although hormones are necessary to sustain human life, an imbalance can cause negative effects on the immune system. For example, an excess of estrogen can exacerbate breast cancer, while a normal estrogen level begets a beneficial effect in women. See id.
141 See EPA Office of Prevention, Pesticides, and Toxic Substances, Questions & Answers, Potential of Chemicals to Affect the Endocrine System (Mar. 1996) <http://www.epa.gov/glnpo/ toxteam/endoqa2.htm>. An example of some chemicals already banned by the United States due to their known propensity to affect the endocrine system are PCBs and Organochlorine pesticides such as DDT, Chlordane, Aldrin/Dieldrin, Endrin, Kepone, Toxaphene, and others. See id.
142 See generally Lee & Hopkins, supra note 5; see Sherrill Sellman, Hormone Heresy, Estrogen’s Deadly Truth, part 1, Nexus Mag., June-July 1996 (discussing the myths of the much–touted benefits of estrogen therapy, and outlining the dangers that estrogen therapy can pose to women).
143 See Lee & Hopkins, supra note 5, at 50. One reason Estrogen Dominance is difficult to treat is because it is not a commonly accepted illness by mainstream physicians. See id.
144 See id. at 49. There are many other symptoms associated with Estrogen Dominance. It would be beyond the scope of this article to describe all of them.
145 See id. at 50. A cycle occurs where stress may cause the Estrogen Dominance, which in turn may cause other symptoms, such as anxiety. The anxiety may affect a woman’s adrenal glands, which are responsible for creating more Estrogen Dominance. See id.
146 See id. Dr. Lee describes the cycle as “a constant state of wired but tired, which will eventually result in dysfunctional adrenal glands, blood sugar imbalances, and debilitating fatigue that may be diagnosed as chronic fatigue syndrome.” Id.
147 See id. at 48-51.
148 See Lee & Hopkins, supra note 5, at 82. According to Dr. Lee, xenohormones with estrogenic effects affect the body in several ways: “(a) some combine with estrogen receptor sites and activate estrogenic action; (b) some appear to induce formation of extra estrogen receptors; (c) others may inhibit the ability of the liver to excrete estrogen; and (d) some may occupy estrogen receptors and inhibit their action.” Id.
149 See id. at 86.
150 See id.
151 See generally Colborn et al, supra note 61.
152 See id.
153 See id. at viii, ix. Vice President Al Gore states: “Our Stolen Future provides a vivid and readable account of emerging scientific research about how a wide range of manmade chemicals disrupt delicate hormone systems. These systems play a critical role in processes ranging from human sexual development to behavior, intelligence and the functioning of the immune system.” Id.
154 See id. at viii.
155 See id. at ix.
156 See Now Appearing at a Store Near You: Organic Meat and Poultry, Envtl. Nutrition, Mar. 1, 1999, available in 1999 WL 14372087.
157 See Natural Beef—No Hormones, No Antibiotics, Natural Beef (last modified Feb. 3, 2000) <http://www.natural-beef.com>. Painted Hills Natural Beef is only one example of producers of natural beef products. Painted Hills offers beef free of hormones and antibiotics.
158 See USDA to Allow Meat to be Labeled Organic, Bus. News (Jan. 15, 1999) <http: //www.foxmarketwire.com/wires/0114/f_ap_0114/f_ap_0114_63.sml>. Organic certification means that no pesticides or preservatives have been sprayed or added to growing fruits or vegetables. It also means that no chemicals or antibiotics are given to the organic animals. See id.
159 See Organic Labels Now Appearing on Food, Health News (Feb. 1, 1999) <http: //herhealthonline.com/news/2–1–99/organic.html>. Prior to this policy, certified organic meat products were the only category of certified organic products that were excluded from using the word “organic” on the label.
160 “Certified Organic By” Labeling on Meat and Poultry Products, 64 Fed. Reg. 17,607, 17,607 (1999).
161 See generally Jody Rathgeb, Sparkling at 3 Area Restaurants, The Richmond Times Dispatch, Mar. 25, 1999.
162 See Bob Condor, U.S. To Establish Rules On Organic Produce, Meats, Chi. Trib., Dec. 16, 1997, available at <http://www.chicago.tribune.com/tools/search/archives/form> (discussing the evolution of the growing demand for organic foods).
163 See id.
164 See id. (stating that, “a decade ago, organic foods were a curiosity largely found in health-food stores and grocery co-ops. The movement, which harkens back to traditional farming practices, preaches that the miracle chemicals of American agriculture are bad for us. The counterculture ate up the message.”).
165 See id. Surveys indicate that about ninety percent of Americans will purchase organic foods if the prices are similar to non-organic foods. See id.
166 See generally PREVENTION: Fighting Cancer with Food, Harv. Health Letter (Harv. Med. Sch. Health Publications Group, Cambridge, Mass.), Dec. 1997.
167 See generally id.
168 See generally Eating to Avoid Cancer, Harv. Health Letter (Harv. Med. Sch. Health Publications Group, Cambridge, Mass.), Mar. 1997.
169 See id.
170 See generally Nutrition-High Protein Diets: Where’s the Beef?, Harv. Health Letter, (Harv. Med. Sch. Health Publications Group, Cambridge, Mass.), Jan. 1, 1997 (discussing generally the health claims associated with high protein diets).
171 See id. The ACS also recommended increasing the intake of plant foods.
172 See generally Risk Factors Diet Changes Can Reduce Cancer Risk, Cancer Wkly. Plus (C.W. Henderson, Atlanta, Ga.) Oct. 6, 1997 (stating that “[m]eat, at most, should be considered as a garnish . . . not the central part of the diet”). John Potter of the Cancer Prevention Research Program in Seattle, Washington, said that medical experts have long suspected the link between high intake of animal fats and meat and cancer development. See id. The article suggests that charred, cured, and smoked meats may be suspect. See id. This article does not address whether hormone or pesticide residues in meats have been studied to rule out a positive correlation. See id.
173 See generally Breast Cancer (Risk) Food Dyes May Raise Breast Cancer Risk, Scientists Find, Cancer Biotechnology Wkly. (C.W. Henderson, Atlanta, Ga.) Nov. 13, 1995.
174 See generally id. Craig Dees, head of the Molecular Toxicology Group in Oak Ridge National Laboratory (ORNL), suggests that Americans eat foods that contain levels of synthetic food dyes that are at least ten million times higher than the level of pesticides ingested. He states that “food dyes, pesticides such as DDT, and pollutants may be responsible for the increasing breast cancer rate among American women because they mimic the effects of the hormone estrogen.”
175 A good example is that although women with a family history of breast cancer are more likely to develop breast cancer, no study has established whether that is a result of heredity or a shared toxic environment. See generally Breast Cancer: The Poor Relation of Cancers; Includes Related Articles on Breast-Feeding, Mammography and Imperial Chemical Industries, Informed Homebirth-Informed Birth & Parenting, Special Delivery, Dec. 22, 1993.
176 See id. (noting that “genetic vulnerability cannot explain the jump from one in twenty women getting cancer in their lifetime in 1950 to one in nine now”).
177 See id. Although an increase in dietary fat has been correlated with higher breast cancer rates, research has failed to establish whether the link is the fat or the toxins stored in the body fat of the animals that we eat.
178 See id. Examples of such evidence are as follows: (1) the high rate of breast cancer in Long Island’s Nassau and Suffolk counties, which were subjected to constant aerial spraying of DDT in the 1950s; (2) higher rates of breast cancer among female chemical factory workers who have been exposed to the chemical Dioxin; and (3) high rates of breast cancer among women golfers, who are exposed to larger than average amounts of pesticides due to their heavy usage of the golf courses. In addition, there is an EPA study indicating that those in counties with hazardous waste disposal sites are 6.5 times more likely to get breast cancer. These are but a few examples. See id.
179 See id.
180 See Martha Irvine, High-Protein Diet Craze is Beefing Up Market Prices (Oct. 22, 1999) (on file with author) (“The high-protein weight-loss diet has been promoted in such best sellers as ‘Protein Power’ and ‘Dr. Atkins’ New Diet Revolution.’ It’s a meat lover’s dream because it recommends lots of protein instead of carbohydrates.”).
181 Samuel Epstein, M.D., is a Professor of Environmental and Occupational Medicine at the School of Public Health, University of Illinois Medical Center, Chicago. He has filed an affidavit in support of the EU ban. His affidavit reads in part:
[b]ased on a review of the scientific literature, Food and Drug Administration (FDA) Freedom of Information Summaries, other U.S. Government reports, and FAO/WHO reports, I conclude that the use of natural and synthetic anabolics in meat production poses serious carcinogenic and other hazards to consumers, with particular reference to breast and other reproductive cancers.
Aff. of Dr. Samuel Epstein in Support of the EU Ban on Trade in Hormone Treated Beef (on file with author).
182 Id. Dr. Epstein, of the Cancer Prevention Coalition, released strong statements regarding hormone-treated meat:
[c]onfidential industry reports to the FDA, obtained under the Freedom of Information Act, reveal high residues of sex hormones in American beef; Following implants in cattle of Synoves-S, a combination of estradiol and progesterone, estradiol levels in meat increased up to 20-fold over what is considered normal. Based on conservative estimates, the amount of estradiol in two hamburgers eaten by an eight-year-old boy could increase his hormone levels by 10%; Much higher hormone levels are found in meat products following illegal implantation in cattle muscle tissue, which is commonplace in U.S. feed lots. See id. A random survey of 32 large feed lots found that as many as half of the cattle had visible “misplaced implants” in muscle, rather than under ear skin; Lifelong exposure to high residues of natural and synthetic sex hormones in meat products poses serious risks of breast and reproductive cancers, which have sharply increased in the U.S. since 1950. See id. Hormone residues are also suspected to be causal factors in premature sexual development in young girls; Repeated assurances on the safety of hormone-implanted meat by two World Health Organization bodies, the Food and Agriculture Organization (FAO) and the Codex Alimentarius Commission (Codex) reflect the biases of senior FDA and USDA officials and industry consultants, and rely heavily upon unpublished industry data and outdated scientific information.
Id.