{"id":185,"date":"2006-12-03T17:48:25","date_gmt":"2006-12-03T21:48:25","guid":{"rendered":"http:\/\/www.healthfreedomusa.org\/codexblog\/action\/step3\/all_codex_docs\/"},"modified":"2008-12-15T23:25:14","modified_gmt":"2008-12-16T03:25:14","slug":"all_codex_docs","status":"publish","type":"page","link":"https:\/\/www.healthfreedomusa.org\/?page_id=185","title":{"rendered":"All Codex Docs &#8211; HTML"},"content":{"rendered":"<style>\n<!--\n \/* Font Definitions *\/\n@font-face\n\t{font-family:\"Times New Roman\";\n\tpanose-1:0 2 2 6 3 5 4 5 2 3;\n\tmso-font-charset:0;\n\tmso-generic-font-family:auto;\n\tmso-font-pitch:variable;\n\tmso-font-signature:50331648 0 0 0 1 0;}\n@font-face\n\t{font-family:Arial;\n\tpanose-1:0 2 11 6 4 2 2 2 2 2;\n\tmso-font-charset:0;\n\tmso-generic-font-family:auto;\n\tmso-font-pitch:variable;\n\tmso-font-signature:50331648 0 0 0 1 0;}\n@font-face\n\t{font-family:\"Courier New\";\n\tpanose-1:0 2 7 3 9 2 2 5 2 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l6\n\t{mso-list-id:2109540789;\n\tmso-list-type:hybrid;\n\tmso-list-template-ids:-1666540680 1377289 1639433 1770505 984073 1639433 1770505 984073 1639433 1770505;}\n@list l6:level1\n\t{mso-level-number-format:alpha-upper;\n\tmso-level-tab-stop:.5in;\n\tmso-level-number-position:left;\n\ttext-indent:-.25in;}\nol\n\t{margin-bottom:0in;}\nul\n\t{margin-bottom:0in;}\n-->\n<\/style>\n<h2>NOTE: You can read these documents in your browser or use your browser&#8217;s Print function to print them out.<\/h2>\n<p>&nbsp;<\/p>\n<table width=\"100%\" border=\"0\" cellpadding=\"20\" cellspacing=\"0\" bgcolor=\"#FFCCFF\">\n<tr>\n<td>\n<div align=\"center\"><a href=\"..\/step3.shtml\">When you&#8217;re done reading, click here to return to the page where you can add your name to the petition. <\/a><\/div>\n<\/td>\n<\/tr>\n<\/table>\n<p>&nbsp;<\/p>\n<hr>\n<p>&nbsp; <\/p>\n<div class=Section1>\n<p class=MsoNormal>To:<span style=\"mso-spacerun: yes\">&nbsp; <\/span>Dr. Barbara<br \/>\nSchneeman<\/p>\n<p class=MsoNormal>Director, Office of Nutritional Products Labeling and<br \/>\nDietary Supplements<\/p>\n<p class=MsoNormal>Food and Drug Administration<\/p>\n<p class=MsoNormal>5600 Fishers Lane<\/p>\n<p class=MsoNormal>Rockville MD 20857-0001<\/p>\n<p class=MsoNormal><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal>To:<span style=\"mso-spacerun: yes\">&nbsp; <\/span>Dr. Edward<br \/>\nScarborough<span style='mso-tab-count:4'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span><\/p>\n<p class=MsoNormal>U.S. CODEX Manager &#8211; U.S. CODEX Office<span\nstyle='mso-tab-count:5'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span><\/p>\n<p class=MsoNormal>United States Department of Agriculture<span\nstyle='mso-tab-count:3'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span><\/p>\n<p class=MsoNormal>South Building, Room 4861<span style='mso-tab-count:2'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span><br \/>\n1400 Independence Ave, SW<span style='mso-tab-count:4'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span><br \/>\nWashington, DC 20250<span style='mso-tab-count:5'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span><\/p>\n<p class=MsoNormal><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal><span style='color:black'>To:<span style=\"mso-spacerun:\nyes\">&nbsp; <\/span>Receiver of Dockets<o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal><span style='color:black'>Dockets Management Branch<o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal><span style='color:black'>Department of Health and Human<br \/>\nServices<o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal><span style='color:black'>Food and Drug Administration<o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal><span style='color:black'>Room 1061, 5630 Fishers Lane<o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal><span style='color:black'>Rockville, MD 20852<\/span> <\/p>\n<p class=MsoNormal><span style='font-size:11.0pt'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal><span style='font-size:11.0pt'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal align=center style='text-align:center'><span\nstyle='font-size:14.0pt'><b>Second Amendment to<o:p><\/o:p><\/b><\/span><\/p>\n<h2>CITIZEN PETITION<\/h2>\n<p class=MsoNormal align=center style='text-align:center'><span\nstyle='font-size:14.0pt'><b>for Furtherance of Dietary Supplement Harmonization<br \/>\nPolicy<o:p><\/o:p><\/b><\/span><\/p>\n<p class=MsoNormal align=center style='text-align:center'><span\nstyle='font-size:14.0pt'><b>by the U.S. CODEX Delegation and Food and Drug<br \/>\nAdministration,<br \/>\nin Harmony with DSHEA and 19 USC 3512<o:p><\/o:p><\/b><\/span><\/p>\n<p class=MsoNormal align=center style='text-align:center'><span\nstyle='font-size:14.0pt'><b><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/b><\/span><\/p>\n<p class=MsoNormal>This Second Amendment is submitted with regard to the<br \/>\nCitizen Petition of June 1, 2005, (Amended June 14, 2005) urging the US Codex<br \/>\nOffice to further, as its policy, harmonization with the CODEX Vitamin and<br \/>\nMineral Guideline (VMG) only in conformity with existing US Law and includes<br \/>\nthe issues raised therein by reference and to refrain from harmonization via<br \/>\neither legislative or regulatory means with any standard, guideline or<br \/>\nregulation which conflicts with or violates US current Law.<span\nstyle=\"mso-spacerun: yes\">&nbsp; <\/span>Attached hereto and made a part hereof<br \/>\nis a copy of the VMG, marked for amendment to conform to existing United States<br \/>\nlaws and regulations.<\/p>\n<p class=MsoNormal><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal>This Petition is further addressed to the Food and Drug<br \/>\nAdministration, as the agency responsible for US Policy on food and nutrient<br \/>\nsafety at the International Food Safety Agency, including herein, by reference<br \/>\nthe original Petition and the First Amendment thereto, copies of which are<br \/>\nappended hereto.<\/p>\n<p class=MsoNormal><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal>Further the Petitioner states: <\/p>\n<p class=MsoNormal><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<h3 style='margin-left:0in'>Factual Background<\/h3>\n<p class=MsoNormal><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal>1.<span style='mso-tab-count:1'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>(a)<br \/>\nThe Vitamin and Mineral Guideline adopted by CODEX on July 4 2005 uses<br \/>\ninappropriate science (i.e., Risk Assessment procedures [Toxicology]) rather<br \/>\nthan appropriate science (i.e., Nutritional Science [Biochemistry]) which is<br \/>\nvery likely to inappropriately mandate maximum permissible levels of nutrients<br \/>\nso low that they are, by intention, without impact on any human being, the<br \/>\nintended outcome of Risk Assessment procedures; a Fact Hearing must be, and<br \/>\npetitioner hereby requests that a fact hearing be, held to determine the<br \/>\nscientifically factual and appropriate basis for the use of Risk Analysis<br \/>\n[Toxicology] rather than more appropriate nutritional [Biochemistry] scientific<br \/>\nstandards in all decisions pertaining to nutrition.<\/p>\n<p class=MsoNormal><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal><span style='font-size:11.0pt'>(b) Codex has accepted the<br \/>\nuse of Risk Assessment procedures for nutrients. However, Risk Assessment is a<br \/>\nmethodology relevant only to toxicology and both irrelevant and antithetical to<br \/>\nNutritional Science and biochemistry.<span style=\"mso-spacerun: yes\">&nbsp;<\/p>\n<p><\/span>The Risk Assessment methodology employed by CODEX has been arbitrarily<br \/>\nmodified without scientific validation or professional consensus to restrict<br \/>\npermissible dosages of nutrients essential to life to levels which can, by<br \/>\nintent, have no impact on any human being, no matter how sensitive.<span\nstyle=\"mso-spacerun: yes\">&nbsp; <\/span>This misapplication, distortion and<br \/>\nmisconstruction of Risk Assessment is in clear contradiction to the principles<br \/>\nof toxicology and scientific Risk Assessment procedures which have been<br \/>\ndeveloped to determine the highest dosages of dangerous industrial and natural<br \/>\ntoxins to which humans can be exposed to without discernable effect. For this<br \/>\nreason, instead of evaluating vitamin and mineral upper limits using<br \/>\ninappropriately modified and unscientific Risk Analysis, US Policy must further<br \/>\nthe use of Nutritional Science to support the liberal access to nutrients<br \/>\nenjoyed under legislative protection in the US.<span style=\"mso-spacerun:\nyes\">&nbsp; <\/span>Under the Dietary Supplements Health and Education Act,<br \/>\npassed by unanimous Congressional consent in 1994, while a nutrient may be<br \/>\ndealt with by the FDA if it is shown to pose a significant risk to health and<br \/>\nsafety, nutrients are treated<span style=\"mso-spacerun: yes\">&nbsp; <\/span>as<br \/>\nfoods which, as such, may have no upper limits set upon their use.<o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal><span style='font-size:11.0pt'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal><span style='font-size:11.0pt'>(c) The United States has<br \/>\nfailed to oppose the use of these scientifically unsupported and unverified<br \/>\nRisk Assessment techniques in the CODEX Committee on Nutrition and Foods for<br \/>\nSpecial Dietary Uses. It has failed to note or oppose these procedures on the<br \/>\nbasis of the substantial Conflict of Interest represented by the publicly<br \/>\nacknowledged personal, professional and financial involvement in commercial<br \/>\nRisk Assessment by the Chairman of the Codex Committee on Nutrition and Foods<br \/>\nfor Special Dietary Uses as the head of the BfR, a commercial Risk Assessment<br \/>\ncompany.<span style=\"mso-spacerun: yes\">&nbsp; <\/span>The United States has<br \/>\nfailed to oppose the classification of nutrients as toxins in 1994, by that<br \/>\nsame committee despite the clear violation of US law which that classification<br \/>\nrepresents. And, since 1994, the United States has failed to present any<br \/>\nopposition to the use of Risk Analysis and other attempts to limit access to<br \/>\nnutrients in order to prevent the restrictive (and illegal under US law)<br \/>\nVitamin and Mineral Guideline from reaching Step 8 and from being ratified on<br \/>\nJuly 4, 2005 at the 28<sup>th<\/sup> CODEX ALIMETNARIUS Commission meeting in<br \/>\nRome, Italy, contrary to DSHEA (Dietary Supplement health and Education Act of<br \/>\n1994) and the unanimous determination of Congress that Dietary Supplements are<br \/>\nFoods, not toxic substances and, as foods, can have no upper limit set upon<br \/>\ntheir intake or use.<o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal>(d) U.S. District Court Judge Tena Campbell stated in the<br \/>\nEphedra Decision, April 2005 (<i>Nutraceutical Corporation and Solaray, Inc. v.<br \/>\nLester Crawford, Acting Commissioner, U.S. Food and Drug Administration<\/i><span\nstyle='font-style:normal'>, Case No. 2:04CV409 TC, USDC, Utah Central<br \/>\nDivision), <\/span><\/p>\n<p class=MsoNormal><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal>&quot;the legislative history of the DSHEA indicates that<br \/>\nCongress generally intended to harmonize the treatment of dietary supplements<br \/>\nwith that of foods when it added the dietary supplement subsection&#8230;&quot;<\/p>\n<p class=MsoNormal><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal><span style='font-size:11.0pt'>(e) The CODEX Technical<br \/>\nReport discussing the application of Risk Assessment to nutrients <span\nclass=MsoFootnoteReference><span style=\"mso-spacerun: yes\">&nbsp;<\/span><\/span>makes<br \/>\nit clear that this procedure does not apply to nutrients because, unlike drugs,<br \/>\nthey have minimum intake limits that are required for life and health.<span\nstyle=\"mso-spacerun: yes\">&nbsp; <\/span>Risk Assessment procedures were<br \/>\nmodified for application to vitamin and mineral supplements without scientific<br \/>\nvalidation, peer review or clinical testing. There is a considerable body of<br \/>\nliterature supporting the nutritional harm caused by low-level intake of<br \/>\nessential and vital nutrients. Has the United States held a public fact finding<br \/>\nhearing to determine if this jerry-rigged statistical system has any<br \/>\napplicability to Nutritional Science and what the risks to the US and global<br \/>\npopulation are when Risk Assessment is applied to nutrients? If not, why has<br \/>\nthe US supported the use of this technique in the nutritional determinations made<br \/>\nby the CCNFSDU when so many lives are at stake in this issue, estimated by<br \/>\npublic health scientists to exceed 3 Billion consequential deaths<br \/>\nworld-wide?<span style=\"mso-spacerun: yes\">&nbsp; <\/span>Why has the US<br \/>\nsupported and adopted this scientifically, biologically and factually<br \/>\nindefensible Policy which should be abandoned in favor of a Policy which<br \/>\nsupports and promotes nutrients as foods, as DSHEA mandates, as the domestic<br \/>\nand international standard which are so strongly supported by both science and<br \/>\nUS Law? <\/span><span style=\"mso-spacerun: yes\">&nbsp;<\/span>A fact Hearing must<br \/>\nbe, and petitioner hereby request that a fact hearing be, held to determine the<br \/>\nimpact on public health in the United States from the use of Risk Analysis<br \/>\n[Toxicology] rather than more appropriate nutritional [Biochemistry] scientific<br \/>\nstandards.<\/p>\n<p class=MsoNormal><span style='font-size:11.0pt'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal><span style='font-size:11.0pt'>(f) We have appended hereto,<br \/>\nand make part hereof, the Alliance for Natural Health (ANH) and Citizens for<br \/>\nHealth (CFH) comments on the failure of toxic Risk Assessment to conform to<br \/>\nstandards of science.<o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<h3 style='margin-left:0in'>Legal Authority<\/h3>\n<p class=MsoNormal><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal>2.<span style='mso-tab-count:1'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>(a)<br \/>\nThe US Codex Office, the FDA and all other involved agencies have legal<br \/>\nauthority to further international harmonization only in conformity with US<br \/>\nlaw:<\/p>\n<p class=MsoNormal><span style='font-size:10.0pt'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyTextIndent style='margin-left:0in'>Title 19, Section 3512,<br \/>\nforbids the US from harmonizing with standards which violate US law;<\/p>\n<p class=MsoNormal><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal>The Dietary Supplement Health Education Act (DSHEA), 1994<br \/>\nclassifies supplements as foods which therefore may have no Safe Upper Limits,<br \/>\nMaximum Permissible Upper Limits or other restrictions upon their use.<o:p><\/o:p><\/p>\n<p class=MsoNormal><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='text-indent:.5in'>(b) FDA has adopted a policy of<br \/>\nharmonization with International Standards, even where those standards are not<br \/>\nfinalized.<span style=\"mso-spacerun: yes\">&nbsp; <\/span>&quot;In a notice published<br \/>\nin the Federal Register of October 11, 1995 (60 FR 53078), FDA articulated its<br \/>\npolicy regarding the development and use of standards with respect to the<br \/>\nharmonization of various national and international regulatory requirements and<br \/>\nguidelines&quot; &#8211; <a href=\"http:\/\/www.healthfreedomusa.org\/wp-content\/plugins\/url-cloak-encrypt\/url.php?id=aHR0cDovL3d3dy5jZnNhbi5mZGEuZ292L35scmQvZnI5NzA3MDcuaHRtbA==\" ><span\nstyle='color:windowtext'>http:\/\/www.cfsan.fda.gov\/~lrd\/fr970707.html<\/span><\/a><\/p>\n<p>.<\/p>\n<p class=MsoFooter style='tab-stops:.5in'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='text-indent:.5in'>(c) The adoption of the Risk<br \/>\nAssessment Model and the anti-DSHEA harmonization Policy are <i>ultra vires<\/i><span\nstyle='font-style:normal'> and premature; have occurred without sufficient<br \/>\nPublic Hearings and in direct contravention of the Public Policy of the United<br \/>\nStates as enacted by Congress.<span style=\"mso-spacerun: yes\">&nbsp; <\/span>The<br \/>\nappropriate US agencies must therefore assert a Nutritional Standard as the<br \/>\nonly lawful alternative to the inappropriate and unscientific use of<br \/>\ntoxicological Risk Assessment with regard to Dietary Substances.<span\nstyle=\"mso-spacerun: yes\">&nbsp; <\/span>It is incumbent upon the United States<br \/>\ntherefore to ensure that the proper science is presented and considered in the<br \/>\nprocess of attempting to set upper limits for nutrient supplements and to<br \/>\nvigorously support the reopening of the Vitamin and Mineral Guideline to<br \/>\ncorrect its scientific deficiencies since the science upon which it is based,<br \/>\nrelying on toxicology while ignoring the appropriate science, biochemistry, is<br \/>\nflawed, creating a position that is contrary to US legal requirements and<br \/>\ndomestic (as well as global) health and well being of every man, woman and<br \/>\nchild on the planet.<\/span><\/p>\n<p class=MsoFooter style='tab-stops:.5in'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='text-indent:.5in'>(d) The Natural Solutions<br \/>\nFoundation, in cooperation with Citizens for Health, has caused its attorneys<br \/>\nto prepare a Revised Version of the Vitamin and Mineral Guideline more in<br \/>\nconformity with the requirements of Law.<span style=\"mso-spacerun: yes\">&nbsp;<br \/>\n<\/span>A copy of the Revised Version is attached hereto and made a part hereof<br \/>\n(together with a comparison copy, showing the specific changes requested).<\/p>\n<p class=MsoNormal><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<h4>Environmental Statement<\/h4>\n<p class=MsoNormal><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal>3.<span style='mso-tab-count:1'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>(a)<br \/>\n<span style='color:black'>Environmental Impact information is generally<br \/>\nrequired only if the petition requests approval of food or color additives,<br \/>\ndrugs, biological products, animal drugs, or certain medical devices, or for a<br \/>\nfood to be categorized as GRAS (generally recognized as safe) under the<br \/>\nProcedures for preparing environmental impact statements found in Title 21,<br \/>\nPart 25 of the Code of Federal Regulations. An environmental impact statement<br \/>\nis therefore not required.<\/span><\/p>\n<p class=MsoNormal><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<h4>Actions requested<\/h4>\n<p class=MsoNormal><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal>4.<span style=\"mso-spacerun: yes\">&nbsp; <\/span>The<br \/>\nPetitioner requests the following Actions by the agencies, with regard to CODEX<br \/>\nand the International Food Safety Agency:<\/p>\n<p class=MsoNormal><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal>(a) The opening of an appropriate Docket for this Petition<br \/>\nand for consideration of the Revised Version of the Vitamin and Mineral<br \/>\nGuideline.<\/p>\n<p class=MsoNormal><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal>(b) The holding of Public Hearings on following Questions of<br \/>\nFact:<\/p>\n<p class=MsoNormal><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal>1. Whether or not the use of Toxic Risk Assessment to<br \/>\ndetermine the allowable forms and dosages of Vitamins and Minerals will promote<br \/>\npublic health.<span style=\"mso-spacerun: yes\">&nbsp; <\/span>Petitioners assert<br \/>\nit will not, as the use of Risk Assessment is inappropriate science with<br \/>\nreference to Foods, including Vitamins and Minerals<\/p>\n<p class=MsoNormal><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal>2. Whether forms and dosages of Vitamins and Minerals<br \/>\ndetermined through Toxic Risk Assessment will adversely impact on the health<br \/>\nand well-being of the residents and Citizens of the United States. <\/p>\n<p class=MsoNormal><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal>(c) (1) The adoption of the Revised Version of the Vitamin<br \/>\nand Mineral Guideline (attached hereinafter) to promote harmonization in<br \/>\nconformity with United States Law, and (2) support for such harmonization at<br \/>\nfuture CODEX and International Food Safety Agency meetings.<\/p>\n<p class=MsoNormal><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal><span style='color:black'>The undersigned certifies, that,<br \/>\nto the best knowledge and belief of the undersigned, this petition includes all<br \/>\ninformation and views on which the petition relies, and that it includes<br \/>\nrepresentative data and information known to the petitions that are unfavorable<br \/>\nto the petition.<\/span><\/p>\n<p class=MsoNormal><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal><span style='font-size:11.0pt'>Dated:<span\nstyle=\"mso-spacerun: yes\">&nbsp; <\/span>October 14, 2005<o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal><span style='font-size:11.0pt'><b><span style='mso-tab-count:\n6'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>Natural<br \/>\nSolutions Foundation<o:p><\/o:p><\/b><\/span><\/p>\n<p class=MsoNormal>Cc:<span style=\"mso-spacerun: yes\">&nbsp; <\/span>George W.<br \/>\nBush, President<span style='font-size:11.0pt'><o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal>Richard B. Cheney, Vice President<o:p><\/o:p><\/p>\n<p class=MsoNormal>Secretary of HHS<span style='font-size:11.0pt'><span\nstyle='mso-tab-count:4'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>___________________________________________<o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal>Secretary of Commerce<span style='font-size:11.0pt'><span\nstyle='mso-tab-count:3'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>Maj.<br \/>\nGen. Albert N. Stubblebine III (US Army, Ret.) <o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal>Secretary of Agriculture<span style='mso-tab-count:3'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span><span\nstyle='font-size:11.0pt'>President<span style='mso-tab-count:3'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span><o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal>Secretary of Transportation<span style='mso-tab-count:3'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>Natural<br \/>\nSolutions Foundation<o:p><\/o:p><\/p>\n<p class=MsoNormal>Commissioner of EPA<o:p><\/o:p><\/p>\n<p class=MsoFooter style='tab-stops:.5in'>Commissioner of FDA<o:p><\/o:p><\/p>\n<p class=MsoNormal>Barbara Schneeman, FDA<span style='font-size:11.0pt'><span\nstyle='mso-tab-count:5'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span><o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal>Sen. William Frist, MD<span style='font-size:11.0pt'><span\nstyle='mso-tab-count:3'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>___________________________________________<\/span><o:p><\/o:p><\/p>\n<p class=MsoNormal><span style='font-size:11.0pt'>Rep. Dennis Hastert<span\nstyle='mso-tab-count:4'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>Rima<br \/>\nLaibow, MD<o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal><span style='font-size:11.0pt'>Sen. Harry Reid<span\nstyle='mso-tab-count:5'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>Medical<br \/>\nDirector<o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal>Rep. Nancy Pelosi<span style='mso-tab-count:4'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>Natural<br \/>\nSolutions Foundation<o:p><\/o:p><\/p>\n<p class=MsoNormal><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal>Prepared by:<span style='mso-tab-count:5'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span><span\nstyle='font-size:11.0pt'><b>Natural Solutions Foundation<\/b><\/span><o:p><\/o:p><\/p>\n<p class=MsoNormal>Ralph Fucetola, JD<span style='mso-tab-count:4'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span><br \/>\n<span style='font-size:11.0pt'>POB 722<\/span><o:p><\/o:p><\/p>\n<p class=MsoNormal><span style='mso-tab-count:6'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span><span\nstyle='font-size:11.0pt'>Maryville MO 64468<\/span><o:p><\/o:p><\/p>\n<p><span style='font-size:10.0pt;font-family:Arial;mso-ansi-language:EN-US;\nmso-fareast-language:EN-US'><br clear=ALL style='page-break-before:always'><br \/>\n<\/span><\/p>\n<hr>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'>Revised<br \/>\nVersion<o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'>Text<br \/>\nof final Codex Vitamin and Mineral Guideline.<br \/>\nMarked for Amendment<o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal><span style='font-size:14.0pt'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal><span style='font-size:14.0pt'>Deletions <s>struck through<\/s>;<br \/>\nadditions <u>underlined<\/u>.<o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><br \/>\nFinalized by the Codex Alimentarius Commission July 4, 2005<br \/>\nGuidelines for Vitamin and Mineral Food Supplements <o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal><span style='font-size:14.0pt'><br \/>\nPREAMBLE<o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><br \/>\n<s>Most people who have access to a balanced diet can usually obtain all the<br \/>\nnutrients they require from their normal diet. Because foods contain many<br \/>\nsubstances that promote health, people should therefore by encouraged to select<br \/>\na balanced diet from food before considering any vitamin and mineral supplement.<br \/>\n<o:p><\/o:p><\/s><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><s><br \/>\nIn cases where the intake from the diet is insufficient or where consumers<br \/>\nconsider their diet requires supplementation, vitamin and mineral food<br \/>\nsupplements serve to supplement the daily diet.<\/s> <o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span\nstyle='font-size:14.0pt'><u>The Food and Agriculture Organization (FAO) Expert<br \/>\nConsultation on Food Safety: Science and Ethics, held in Rome, Italy, in<br \/>\nSeptember 2002, set out the following food, nutrition and health rights:<o:p><\/o:p><\/u><\/span><\/p>\n<p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span\nstyle='font-size:14.0pt'><u>\u00ef\u00bf\u00bdThe human right to adequate food is recognized in<br \/>\nseveral instruments under international law. [\u00ef\u00bf\u00bd] The right of every human being<br \/>\nto be free from hunger is fundamental and uncontested. The most important<br \/>\nimplication of the right to adequate food is that states and peoples must be<br \/>\nsupported to enable them to address situations of food insecurity themselves. The<br \/>\nright to culturally acceptable food should not be regarded primarily as a right<br \/>\nto receive a specific type of food aid, but as a right to be supported so as to<br \/>\ncreate one&#8217;s own food security. Support to address sustainable food security<br \/>\nmust therefore also include ensuring the capacity in recipient countries for<br \/>\nfood that is both safe and nutritious.\u00ef\u00bf\u00bd<\/u><a style='mso-footnote-id:ftn1'\nhref=\"#_ftn1\" name=\"_ftnref1\" title=\"\"><span class=MsoFootnoteReference><span\nstyle='mso-special-character:footnote'><![if !supportFootnotes]>[1]<![endif]><\/span><\/span><\/a><u><\/p>\n<p><o:p><\/o:p><\/u><\/span><\/p>\n<p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span\nstyle='font-size:14.0pt'><u>In today\u00ef\u00bf\u00bds world, billions of people in wealthy and<br \/>\nless wealthy countries lack access to a balanced diet capable of providing<br \/>\noptimal nutrition, are beset by challenges of food scarcity and nutritional<br \/>\ninadequacy, and therefore fail to obtain all the nutrients they require from<br \/>\ntheir available diet. Although foods contain many substances that promote<br \/>\nhealth, and people should be encouraged to select a balanced diet from food,<br \/>\nbecause of the widespread lack of balanced diets, and the absence of nutrient<br \/>\ndensity or balance in many widely consumed foods, people should also be<br \/>\nencouraged to consider using vitamin and mineral supplements; national and<br \/>\nglobal food-relief programs should separately ensure this. <o:p><\/o:p><\/u><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><u>Since,<br \/>\nin a vast number of cases, the nutrient intake from the diet is either<br \/>\ninsufficient or insufficiently nutrient-dense to provide optimal health, and<br \/>\nrecognizing that consumers and health professionals often determine that their<br \/>\ndiet requires supplementation, it is appropriate to ensure that ample amounts<br \/>\nof vitamin and mineral food supplements of sufficient quality, variety, and<br \/>\npotency are available to effectively supplement the daily diet as required and<br \/>\ndesired by citizen-consumers of all nation states.<\/u><o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><br \/>\n1. SCOPE <o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><br \/>\n1.1 <s>These<\/s> <u>This framework and its<\/u> guidelines apply to vitamin and<br \/>\nmineral food supplements intended for use in supplementing the daily diet with<br \/>\nvitamins and\/or minerals. <o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><br \/>\n1.2 <u>They also apply to f<\/u>ood supplements containing vitamins and\/or<br \/>\nminerals <s>as well as<\/s> <u>that additionally include<\/u> other ingredients <s>should<br \/>\nalso be in conformity with the specific rules on vitamins and minerals laid<br \/>\ndown in these Guidelines<\/s> <u>found to be safe (i.e. lack proof of harm at<br \/>\ncommonly employed dosages presented by appropriate regulatory authorities) and<br \/>\neffective for their intended use in accordance with clinically, scientifically<br \/>\nand legally sound international standards<\/u>.<o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><\/p>\n<p>1.3. <s>These Guidelines only apply in those jurisdictions where products<br \/>\ndefined in 2.1 are regulated as foods.<\/s><span style=\"mso-spacerun:\nyes\">&nbsp; <\/span><u>This framework and its guidelines apply in all<br \/>\njurisdictions where products defined in 2.1 are marketed, whether as foods,<br \/>\ndrugs, natural substances or under any other category name.<\/u><o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><span\nstyle=\"mso-spacerun: yes\">&nbsp;<\/span><br \/>\n1.4. <u>Vitamin and mineral food supplements, when used in or as f<\/u>oods for<br \/>\nspecial dietary uses as defined in the General Standard for the Labeling of and<br \/>\nClaims for Prepackaged Foods for Special Dietary Uses (CODEX STAN 146-1985) are<br \/>\n<s>not<\/s> covered by <u>this framework and its guidelines<\/u> <s>these<br \/>\nGuidelines<\/s>. <o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><br \/>\n2. DEFINITIONS <o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><br \/>\n2.1 Vitamin and mineral food supplements for the purpose of <s>these<\/s> <u>this<br \/>\nframework and its <\/u>guidelines derive their nutritional relevance primarily<br \/>\nfrom the minerals and\/or vitamins they contain. Vitamin and mineral food<br \/>\nsupplements are sources of concentrated forms of <s>those<\/s> nutrients, alone<br \/>\nor in combinations, marketed in forms such as capsules, tablets, powders, <u>tinctures,<\/u><br \/>\nsolutions, etc., that are designed to be taken in measured small-unit <u>(\u00ef\u00bf\u00bdsmall\u00ef\u00bf\u00bd<br \/>\nas in physical size not \u00ef\u00bf\u00bdlow\u00ef\u00bf\u00bd as in potency or strength)<\/u> quantities <s>but<\/s><\/p>\n<p><u>at amounts from low to high potency<\/u> that are not in a conventional food<br \/>\nform and whose purpose is to supplement the intake of vitamins and\/or minerals<br \/>\nfrom the normal diet. <o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><br \/>\n3. COMPOSITION <o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><br \/>\n3.1 Selection of vitamins and minerals <o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><br \/>\n3.1.1. Vitamin and mineral food supplements <u>are food products (whatever else<br \/>\nthey may be called) that<\/u> <s>should<\/s> contain vitamins\/provitamins and<u>\/or<\/u><\/p>\n<p>minerals whose nutritional value for human beings has been <s>proven<\/s> <u>established<\/u><br \/>\nby <u>clinical and<\/u> scientific data and whose status as vitamins and<br \/>\nminerals is recognized by FAO, <s>and<\/s> WHO <u>and\/or other appropriate<br \/>\nscientific or legal authority applying sound clinical, scientific and legal<br \/>\nprinciples, and whose form is that set out in section 2.1 of this framework and<br \/>\nguidelines<\/u>. <br style='mso-special-character:line-break'><br \/>\n<![if !supportLineBreakNewLine]><br style='mso-special-character:line-break'><br \/>\n<![endif]><o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'>3.1.2.<br \/>\nThe sources of vitamins and minerals may be either natural or synthetic and<br \/>\ntheir selection should be based on considerations such as safety<u>, efficacy<\/u><br \/>\nand bioavailability. In addition, purity criteria should take into account<br \/>\nFAO\/WHO <s>standards, or if FAO\/WHO standards are not available, international<br \/>\nPharmacopoeias or recognized international standards. In the absence of<br \/>\ncriteria from these sources, national legislation may be used<\/s><u> determinations,<br \/>\ninternational pharmacopoeias and other scientifically and\/or legally sound<br \/>\ninternational standards<\/u>.<o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><br \/>\n3.1.3 Vitamin and mineral food supplements may contain all vitamins and<br \/>\nminerals that comply with the criteria in 3.1.1. a single and\/or mineral <u>form<\/u><br \/>\nor an appropriate combination of vitamins and\/or minerals. <o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><br \/>\n3.2 Contents of vitamins and minerals <o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><br \/>\n3.2.1 <s>The minimum level of each vitamin and\/or mineral contained in a<br \/>\nvitamin and mineral food supplement per daily portion of consumption as<br \/>\nsuggested by the manufacturer should be 15% of the recommended daily intake as<br \/>\ndetermined by FAO\/WHO.<\/s><o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><span\nstyle=\"mso-spacerun: yes\">&nbsp;<\/span><o:p><\/o:p><\/span><\/p>\n<p class=MsoPlainText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><u>An<br \/>\nacceptable range of oral intake (AROI),<\/u><a style='mso-footnote-id:ftn2'\nhref=\"#_ftn2\" name=\"_ftnref2\" title=\"\"><span class=MsoFootnoteReference><span\nstyle='mso-special-character:footnote'><![if !supportFootnotes]>[2]<![endif]><\/span><\/span><\/a><u><br \/>\nbetween known deficiency and established toxicity, each based on clinical<br \/>\nobservation and\/or laboratory assessment, that can be considered a range of<br \/>\noptimal intakes for each vitamin and\/or mineral contained in a vitamin and<br \/>\nmineral food supplement per daily portion of consumption as suggested by the<br \/>\nmanufacturer should be set, taking the following criteria into account: <o:p><\/o:p><\/u><\/span><\/p>\n<p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span\nstyle='font-size:14.0pt'><u>(a) Consumers should not be led to believe, by the<br \/>\namounts of or information about vitamins and minerals in supplement products,<br \/>\nor by officially recommended nutrient intakes (e.g. Population Reference Intake<br \/>\nor Recommended Daily Allowance values) that there is exact quantitative<br \/>\nknowledge of what individuals should eat in order to attain and maintain<br \/>\noptimal health. <o:p><\/o:p><\/u><\/span><\/p>\n<p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span\nstyle='font-size:14.0pt'><u>(b) Biochemical individuality, stage of life and<br \/>\ngender are among the factors considered in establishing reference intake values<br \/>\nof vitamins and minerals for populations that require the setting of a broad<br \/>\nrange (rather than specific upper and\/or lower limits) of nutrient intake<br \/>\nexcept to convey an understanding of the quantity of nutrients contained in the<br \/>\nproduct. <o:p><\/o:p><\/u><\/span><\/p>\n<p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span\nstyle='font-size:14.0pt'><u>(c) the AROI for vitamins and minerals shall be<br \/>\nestablished by appropriate scientific risk analysis consisting of<span\nstyle=\"mso-spacerun: yes\">&nbsp; <\/span>risk assessment, risk management and<br \/>\nrisk communication based on generally accepted scientific procedures, taking<br \/>\ninto consideration, as appropriate, the varying degrees of sensitivity of<br \/>\ndifferent individual consumers and consumer population groups; <o:p><\/o:p><\/u><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><u>(d)<br \/>\nThe AROI includes the daily intake of vitamins and minerals from other dietary<br \/>\nsources as established by aggregated clinical observations rather than abstract<br \/>\nhandbooks or other sources of imputed nutrient content of foods<\/u>.<o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><\/p>\n<p><s>3.2.2 Maximum amounts of vitamins and minerals in vitamin and mineral food<br \/>\nsupplements per daily portion of consumption as recommended by the manufacturer<br \/>\nshall be set taking the following criteria into account:<o:p><\/o:p><\/s><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><s><br \/>\n(a) upper safe levels of vitamins and mineral established by scientific risk<br \/>\nassessment based on generally accepted scientific data, taking into<br \/>\nconsideration, as appropriate, the varying degrees of sensitivity of different<br \/>\nconsumer groups; <o:p><\/o:p><\/s><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><s><br \/>\n(b) the daily intake of vitamins and minerals from other dietary sources. <o:p><\/o:p><\/s><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><s><br \/>\nWhen the maximum levels are set, due account may be taken of the reference<br \/>\nintake values of vitamins and minerals for the population. This provision<br \/>\nshould not lead to setting of maximum levels that are solely based on<br \/>\nrecommended nutrient intakes (e.g. Population Reference Intake or Recommended<br \/>\nDaily Allowance values).<\/s><o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><span\nstyle=\"mso-spacerun: yes\">&nbsp;<\/span><br \/>\n4. PACKAGING<o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><br \/>\n4.1 The product shall be packed in containers which will safeguard the hygienic<br \/>\nand other qualities of the food. <o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><br \/>\n4.2. The containers, including packaging material, shall be made only of<br \/>\nsubstances which are safe and suitable for their intended use. Where the Codex<br \/>\nAlimentarius Commission has established a standard for any substance used as<br \/>\npackaging material, that standard shall apply. <o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><br \/>\n5. LABELING <o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><br \/>\n5.1 Vitamin and mineral food supplements should be labeled according to the<br \/>\nCodex Standard for the Labeling of Prepackaged Foods (Codex-Stan 1-1985 Rev.<br \/>\n1-1991) as well as according to the General Guidelines on Claims (CAC\/GL<br \/>\n1-1979) <u>with the exception that claims that a balanced diet of ordinary<br \/>\nfoods cannot supply adequate amounts of all nutrients and that identified<br \/>\namounts of vitamins and minerals may be used in the prevention, alleviation,<br \/>\ntreatment or cure of disease, disorder or particular physiological condition<br \/>\ncan be made if substantiated by clinical and scientific evidence<\/u>. <o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><br \/>\n5.2 The name of the product shall be &quot;food supplement&quot; with an<br \/>\nindication of the category(ies) of nutrients or of the individual vitamin(s)<br \/>\nand\/or mineral(s) contained in the product as the case may be. <o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><br \/>\n5.3 The amount of the vitamins and minerals present in the product should be<br \/>\ndeclared in the labeling in numerical form. The units to be used should be<br \/>\nunits of weight consistent with the Codex Guidelines on Nutrition Labeling <u>with<br \/>\nthe caveat that all references to the recommended daily intake, Dietary<br \/>\nReference Intakes (DRIs), or other reference intake values, in all sections of<br \/>\nthis framework and its guidelines are for the purpose of providing consumers<br \/>\nwith a suitable profile of nutrients contained in the food and considered to be<br \/>\nof nutritional importance. The information should not lead consumers to believe<br \/>\nthat there is exact quantitative knowledge of what individuals should eat in<br \/>\norder to maintain health, but rather to convey an understanding of the quantity<br \/>\nof nutrients contained in the product. A more exact quantitative delineation<br \/>\nfor individuals is not valid because there is no meaningful way in which<br \/>\nknowledge about individual requirements can be used in labeling, labels or<br \/>\nother direct to consumer information.<\/u><a style='mso-footnote-id:ftn3'\nhref=\"#_ftn3\" name=\"_ftnref3\" title=\"\"><span class=MsoFootnoteReference><span\nstyle='mso-special-character:footnote'><![if !supportFootnotes]>[3]<![endif]><\/span><\/span><\/a><br \/>\n<o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><br \/>\n5.4 <u>To convey an understanding of the quantity of nutrients contained in the<br \/>\nproduct t<\/u>he amounts of the vitamins and minerals declared should be those per<br \/>\nportion of the product as recommended for daily consumption and if different,<br \/>\nthe amount per unit for <u>and average<\/u> single use may also be given. <o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><br \/>\n5.5 Information on vitamins and minerals should also be expressed as a<br \/>\npercentage of the nutrient reference values mentioned <u>(in the form of<br \/>\nDietary Reference Intakes for example)<\/u>, as the case may be, in the Codex<br \/>\nGuidelines on Nutrition Labeling. <o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><br \/>\n5.6 The label should indicate how the product should be used (quantity,<br \/>\nfrequency, special conditions) <u>under average expectable circumstances<br \/>\nrecognizing that biochemical individuality may significantly alter these<br \/>\nparameters<\/u>. <o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><br \/>\n5.7 The label shall contain advice to the consumer <u>to obtain a personal<br \/>\noptimum daily vitamin and mineral intake level and not to unintentionally<br \/>\nexceed that<\/u> <s>not to exceed the maximum<\/s> one-day amount.<o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><br \/>\n5.8 The label should not state or imply that supplements can be used for the<br \/>\nreplacement of meals or a varied diet. <o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><br \/>\n5.9 The label shall contain a statement that the product should be stored out<br \/>\nof the reach of young children <u>to assist in preventing choking injuries<\/u>.<br \/>\n<o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><u><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/u><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><u><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/u><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><u><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/u><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'>&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;-<br \/>\n1 This refers to the physical forms of the vitamin and mineral food supplements<br \/>\nnot to the potency of the supplements.<o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/span><\/p>\n<p class=MsoPlainText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><u>2<br \/>\nPrinciples And Methods For The Assessment Of Risk From Essential Trace Elements<br \/>\n<a href=\"http:\/\/www.healthfreedomusa.org\/wp-content\/plugins\/url-cloak-encrypt\/url.php?id=aHR0cDovL3d3dy5pbmNoZW0ub3JnLyUyMGRvY3VtZW50cy9laGMvZWhjL2VoYzIyOC5odG0jMS4w\" >http:\/\/www.inchem.org\/<br \/>\ndocuments\/ehc\/ehc\/ehc228.htm#1.0<\/a> and Problems Peculiar to the Setting of<br \/>\nLimits for Essential Food Elements G.C. Becking Kingston, Ontario, Canada <a\nhref=\"http:\/\/www.nnia.co.za\/CPD\/articles\/risk_assessment.pdf\">http:\/\/www.nnia.co.za\/CPD\/articles\/risk_assessment.pdf<\/a><br \/>\nIn Risk Assessment in the Food Chain of Children, Edited by Peter J. Aggett and<br \/>\nHarry A Kuiper. Nestl\u00ef\u00bf\u00bd Nutrition Workshop Series, Pediatric Program, Vol. 44,<br \/>\nNestec Ltd., Vevey\/Lippincott Williams &amp; Wilkins, Philadelphia \u00ef\u00bf\u00bd 2000 each<br \/>\ndiscuss AROI.<span style=\"mso-spacerun: yes\">&nbsp; <\/span>Becking says \u00ef\u00bf\u00bdThe<br \/>\nproposed methodology is discussed with regard to its applicability to essential<br \/>\ntrace elements. However, it should be applicable to all essential food<br \/>\ncomponents subject to homeostatic control by the human body.\u00ef\u00bf\u00bd <o:p><\/o:p><\/u><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><u><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/u><\/span><\/p>\n<p class=MsoFootnoteText><span class=MsoFootnoteReference><span\nstyle='font-size:14.0pt'>3<\/span><\/span><span style='font-size:14.0pt'><u> The<br \/>\ntext of the caveat, line 3 to the end, is from the Codex Guidelines on<br \/>\nNutrition Labeling <a\nhref=\"http:\/\/www.fao.org\/documents\/show_cdr.asp?url_file=\/DOCREP\/005\/Y2770E\/y2770e06.htm\">http:\/\/www.fao.org\/documents\/show_cdr.asp?url_file=\/DOCREP\/005\/Y2770E\/y2770e06.htm<\/a><o:p><\/o:p><\/u><\/span><\/p>\n<p class=MsoFootnoteText><span style='font-size:14.0pt'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/span><\/p>\n<p class=MsoFootnoteText><span style='font-size:14.0pt'>Text prepared by James<br \/>\nTurner, JD, Rima Laibow, MD and Ralph Fucetola, JD<o:p><\/o:p><\/span><\/p>\n<p class=MsoFootnoteText><span style='font-size:14.0pt'>10\/14\/05<o:p><\/o:p><\/span><\/p>\n<p><span style='font-size:11.0pt;font-family:Arial;mso-ansi-language:EN-US;\nmso-fareast-language:EN-US'><br clear=ALL style='page-break-before:always'><br \/>\n<\/span><\/p>\n<hr>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'>Revised<br \/>\nVersion &#8211; Text of final Codex Vitamin and Mineral Guideline.<br \/>\nOffered for Amendment on behalf of<o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'>Natural<br \/>\nSolutions Foundation and Citizens Working Group on Codex<o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><br \/>\nFinalized by the Codex Alimentarius Commission July 4, 2005<br \/>\nGuidelines for Vitamin and Mineral Food Supplements <o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal><span style='font-size:14.0pt'><br \/>\nPREAMBLE<o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal><span style='font-size:14.0pt'><br style='mso-special-character:\nline-break'><br \/>\n<![if !supportLineBreakNewLine]><br style='mso-special-character:line-break'><br \/>\n<![endif]><o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span\nstyle='font-size:14.0pt'>The Food and Agriculture Organization (FAO) Expert<br \/>\nConsultation on Food Safety: Science and Ethics, held in Rome, Italy, in<br \/>\nSeptember 2002, set out the following food, nutrition and health rights:<o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span\nstyle='font-size:14.0pt'>\u00ef\u00bf\u00bdThe human right to adequate food is recognized in<br \/>\nseveral instruments under international law. [\u00ef\u00bf\u00bd] The right of every human being<br \/>\nto be free from hunger is fundamental and uncontested. The most important<br \/>\nimplication of the right to adequate food is that states and peoples must be<br \/>\nsupported to enable them to address situations of food insecurity themselves.<br \/>\nThe right to culturally acceptable food should not be regarded primarily as a<br \/>\nright to receive a specific type of food aid, but as a right to be supported so<br \/>\nas to create one&#8217;s own food security. Support to address sustainable food<br \/>\nsecurity must therefore also include ensuring the capacity in recipient<br \/>\ncountries for food that is both safe and nutritious.\u00ef\u00bf\u00bd<a style='mso-footnote-id:\nftn4' href=\"#_ftn4\" name=\"_ftnref4\" title=\"\"><span class=MsoFootnoteReference><span\nstyle='mso-special-character:footnote'><![if !supportFootnotes]>[4]<![endif]><\/span><\/span><\/a><br \/>\n<o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span\nstyle='font-size:14.0pt'>In today\u00ef\u00bf\u00bds world, billions of people in wealthy and<br \/>\nless wealthy countries lack access to a balanced diet capable of providing<br \/>\noptimal nutrition, are beset by challenges of food scarcity and nutritional<br \/>\ninadequacy, and therefore fail to obtain all the nutrients they require from<br \/>\ntheir available diet. Although foods contain many substances that promote<br \/>\nhealth, and people should be encouraged to select a balanced diet from food,<br \/>\nbecause of the widespread lack of balanced diets, and the absence of nutrient<br \/>\ndensity or balance in many widely consumed foods, people should also be encouraged<br \/>\nto consider using vitamin and mineral supplements; national and global<br \/>\nfood-relief programs should separately ensure this. <o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'>Since,<br \/>\nin a vast number of cases, the nutrient intake from the diet is either<br \/>\ninsufficient or insufficiently nutrient-dense to provide optimal health, and<br \/>\nrecognizing that consumers and health professionals often determine that their<br \/>\ndiet requires supplementation, it is appropriate to ensure that ample amounts<br \/>\nof vitamin and mineral food supplements of sufficient quality, variety, and<br \/>\npotency are available to effectively supplement the daily diet as required and<br \/>\ndesired by citizen-consumers of all nation states.<o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><br \/>\n1. SCOPE <o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><br \/>\n1.1 This framework and its guidelines apply to vitamin and mineral food<br \/>\nsupplements intended for use in supplementing the daily diet with vitamins<br \/>\nand\/or minerals. <o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><br \/>\n1.2 They also apply to food supplements containing vitamins and\/or minerals<br \/>\nthat additionally include other ingredients found to be safe (i.e. lack proof<br \/>\nof harm at commonly employed dosages presented by appropriate regulatory<br \/>\nauthorities) and effective for their intended use in accordance with<br \/>\nclinically, scientifically and legally sound international standards.<o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><br \/>\n1.3. This framework and its guidelines apply in all jurisdictions where<br \/>\nproducts defined in 2.1 are marketed, whether as foods, drugs, natural<br \/>\nsubstances or under any other category name.<o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><span\nstyle=\"mso-spacerun: yes\">&nbsp;<\/span><br \/>\n1.4. Vitamin and mineral food supplements, when used in or as foods for special<br \/>\ndietary uses as defined in the General Standard for the Labeling of and Claims<br \/>\nfor Prepackaged Foods for Special Dietary Uses (CODEX STAN 146-1985) are<br \/>\ncovered by this framework and its guidelines. <o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><br \/>\n2. DEFINITIONS <o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><br \/>\n2.1 Vitamin and mineral food supplements for the purpose of this framework and<br \/>\nits guidelines derive their nutritional relevance primarily from the minerals<br \/>\nand\/or vitamins they contain. Vitamin and mineral food supplements are sources<br \/>\nof concentrated forms of nutrients, alone or in combinations, marketed in forms<br \/>\nsuch as capsules, tablets, powders, tinctures, solutions, etc., that are<br \/>\ndesigned to be taken in measured small-unit (\u00ef\u00bf\u00bdsmall\u00ef\u00bf\u00bd as in physical size not<br \/>\n\u00ef\u00bf\u00bdlow\u00ef\u00bf\u00bd as in potency or strength) quantities at amounts from low to high potency<br \/>\nthat are not in a conventional food form and whose purpose is to supplement the<br \/>\nintake of vitamins and\/or minerals from the normal diet. <o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><br \/>\n3. COMPOSITION <o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><br \/>\n3.1 Selection of vitamins and minerals <o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><br \/>\n3.1.1. Vitamin and mineral food supplements are food products (whatever else<br \/>\nthey may be called) that contain vitamins\/provitamins and\/or minerals whose<br \/>\nnutritional value for human beings has been established by clinical and<br \/>\nscientific data and whose status as vitamins and minerals is recognized by FAO,<br \/>\nWHO and\/or other appropriate scientific or legal authority applying sound<br \/>\nclinical, scientific and legal principles, and whose form is that set out in<br \/>\nsection 2.1 of this framework and guidelines. <br style='mso-special-character:\nline-break'><br \/>\n<![if !supportLineBreakNewLine]><br style='mso-special-character:line-break'><br \/>\n<![endif]><o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'>3.1.2.<br \/>\nThe sources of vitamins and minerals may be either natural or synthetic and<br \/>\ntheir selection should be based on considerations such as safety, efficacy and<br \/>\nbioavailability. In addition, purity criteria should take into account FAO\/WHO<br \/>\ndeterminations, international pharmacopoeias and other scientifically and\/or<br \/>\nlegally sound international standards.<o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><br \/>\n3.1.3 Vitamin and mineral food supplements may contain all vitamins and<br \/>\nminerals that comply with the criteria in 3.1.1. a single and\/or mineral form<br \/>\nor an appropriate combination of vitamins and\/or minerals. <o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><br \/>\n3.2 Contents of vitamins and minerals <o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><br \/>\n3.2.1 An acceptable range of oral intake (AROI),<a style='mso-footnote-id:ftn5'\nhref=\"#_ftn5\" name=\"_ftnref5\" title=\"\"><span class=MsoFootnoteReference><span\nstyle='mso-special-character:footnote'><![if !supportFootnotes]>[5]<![endif]><\/span><\/span><\/a><br \/>\nbetween known deficiency and established toxicity, each based on clinical<br \/>\nobservation and\/or laboratory assessment, that can be considered a range of<br \/>\noptimal intakes for each vitamin and\/or mineral contained in a vitamin and<br \/>\nmineral food supplement per daily portion of consumption as suggested by the<br \/>\nmanufacturer should be set, taking the following criteria into account: <o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span\nstyle='font-size:14.0pt'>(a) Consumers should not be led to believe, by the<br \/>\namounts of or information about vitamins and minerals in supplement products,<br \/>\nor by officially recommended nutrient intakes (e.g. Population Reference Intake<br \/>\nor Recommended Daily Allowance values) that there is exact quantitative<br \/>\nknowledge of what individuals should eat in order to attain and maintain<br \/>\noptimal health. <o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span\nstyle='font-size:14.0pt'>(b) Biochemical individuality, stage of life and<br \/>\ngender are among the factors considered in establishing reference intake values<br \/>\nof vitamins and minerals for populations that require the setting of a broad<br \/>\nrange (rather than specific upper and\/or lower limits) of nutrient intake<br \/>\nexcept to convey an understanding of the quantity of nutrients contained in the<br \/>\nproduct. <o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span\nstyle='font-size:14.0pt'>(c) the AROI for vitamins and minerals shall be<br \/>\nestablished by appropriate scientific risk analysis consisting of<span\nstyle=\"mso-spacerun: yes\">&nbsp; <\/span>risk assessment, risk management and<br \/>\nrisk communication based on generally accepted scientific procedures, taking<br \/>\ninto consideration, as appropriate, the varying degrees of sensitivity of<br \/>\ndifferent individual consumers and consumer population groups; <o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'>(d)<br \/>\nThe AROI includes the daily intake of vitamins and minerals from other dietary<br \/>\nsources as established by aggregated clinical observations rather than abstract<br \/>\nhandbooks or other sources of imputed nutrient content of foods.<o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><span\nstyle=\"mso-spacerun: yes\">&nbsp;<\/span><br \/>\n4. PACKAGING<o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><br \/>\n4.1 The product shall be packed in containers which will safeguard the hygienic<br \/>\nand other qualities of the food. <o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><br \/>\n4.2. The containers, including packaging material, shall be made only of<br \/>\nsubstances which are safe and suitable for their intended use. Where the Codex<br \/>\nAlimentarius Commission has established a standard for any substance used as<br \/>\npackaging material, that standard shall apply. <o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><br \/>\n5. LABELING <o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><br \/>\n5.1 Vitamin and mineral food supplements should be labeled according to the<br \/>\nCodex Standard for the Labeling of Prepackaged Foods (Codex-Stan 1-1985 Rev.<br \/>\n1-1991) as well as according to the General Guidelines on Claims (CAC\/GL<br \/>\n1-1979) with the exception that claims that a balanced diet of ordinary foods<br \/>\ncannot supply adequate amounts of all nutrients and that identified amounts of<br \/>\nvitamins and minerals may be used in the prevention, alleviation, treatment or<br \/>\ncure of disease, disorder or particular physiological condition can be made if<br \/>\nsubstantiated by clinical and scientific evidence. <o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><br \/>\n5.2 The name of the product shall be &quot;food supplement&quot; with an<br \/>\nindication of the category(ies) of nutrients or of the individual vitamin(s)<br \/>\nand\/or mineral(s) contained in the product as the case may be. <o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><br \/>\n5.3 The amount of the vitamins and minerals present in the product should be<br \/>\ndeclared in the labeling in numerical form. The units to be used should be<br \/>\nunits of weight consistent with the Codex Guidelines on Nutrition Labeling with<br \/>\nthe caveat that all references to the recommended daily intake, Dietary<br \/>\nReference Intakes (DRIs), or other reference intake values, in all sections of<br \/>\nthis framework and its guidelines are for the purpose of providing consumers<br \/>\nwith a suitable profile of nutrients contained in the food and considered to be<br \/>\nof nutritional importance. The information should not lead consumers to believe<br \/>\nthat there is exact quantitative knowledge of what individuals should eat in<br \/>\norder to maintain health, but rather to convey an understanding of the quantity<br \/>\nof nutrients contained in the product. A more exact quantitative delineation<br \/>\nfor individuals is not valid because there is no meaningful way in which<br \/>\nknowledge about individual requirements can be used in labeling, labels or<br \/>\nother direct to consumer information.<a style='mso-footnote-id:ftn6'\nhref=\"#_ftn6\" name=\"_ftnref6\" title=\"\"><span class=MsoFootnoteReference><span\nstyle='mso-special-character:footnote'><![if !supportFootnotes]>[6]<![endif]><\/span><\/span><\/a><br \/>\n<o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><br \/>\n5.4 To convey an understanding of the quantity of nutrients contained in the<br \/>\nproduct the amounts of the vitamins and minerals declared should be those per<br \/>\nportion of the product as recommended for daily consumption and if different,<br \/>\nthe amount per unit for and average single use may also be given. <o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><br \/>\n5.5 Information on vitamins and minerals should also be expressed as a percentage<br \/>\nof the nutrient reference values mentioned (in the form of Dietary Reference<br \/>\nIntakes for example), as the case may be, in the Codex Guidelines on Nutrition<br \/>\nLabeling. <o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><br \/>\n5.6 The label should indicate how the product should be used (quantity, frequency,<br \/>\nspecial conditions) under average expectable circumstances recognizing that<br \/>\nbiochemical individuality may significantly alter these parameters. <o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><br \/>\n5.7 The label shall contain advice to the consumer to obtain a personal optimum<br \/>\ndaily vitamin and mineral intake level and not to unintentionally exceed that<br \/>\none-day amount.<o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><br \/>\n5.8 The label should not state or imply that supplements can be used for the<br \/>\nreplacement of meals or a varied diet. <o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><\/p>\n<p>5.9 The label shall contain a statement that the product should be stored out<br \/>\nof the reach of young children to assist in preventing choking injuries. <o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:14.0pt;font-family:\"Times New Roman\"'>&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;-<br \/>\n<\/span><span style='font-size:12.0pt;font-family:\"Times New Roman\"'>1 This<br \/>\nrefers to the physical forms of the vitamin and mineral food supplements not to<br \/>\nthe potency of the supplements.<o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:12.0pt;font-family:\"Times New Roman\"'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/span><\/p>\n<p class=MsoPlainText><span style='font-size:12.0pt;font-family:\"Times New Roman\"'>2<br \/>\nPrinciples And Methods For The Assessment Of Risk From Essential Trace Elements<\/p>\n<p><a href=\"http:\/\/www.healthfreedomusa.org\/wp-content\/plugins\/url-cloak-encrypt\/url.php?id=aHR0cDovL3d3dy5pbmNoZW0ub3JnLyUyMGRvY3VtZW50cy9laGMvZWhjL2VoYzIyOC5odG0jMS4w\" >http:\/\/www.inchem.org\/<br \/>\ndocuments\/ehc\/ehc\/ehc228.htm#1.0<\/a> and Problems Peculiar to the Setting of<br \/>\nLimits for Essential Food Elements G.C. Becking Kingston, Ontario, Canada <a\nhref=\"http:\/\/www.nnia.co.za\/CPD\/articles\/risk_assessment.pdf\">http:\/\/www.nnia.co.za\/CPD\/articles\/risk_assessment.pdf<\/a><br \/>\nIn Risk Assessment in the Food Chain of Children, Edited by Peter J. Aggett and<br \/>\nHarry A Kuiper. Nestl\u00ef\u00bf\u00bd Nutrition Workshop Series, Pediatric Program, Vol. 44,<br \/>\nNestec Ltd., Vevey\/Lippincott Williams &amp; Wilkins, Philadelphia \u00ef\u00bf\u00bd 2000 each<br \/>\ndiscuss AROI.<span style=\"mso-spacerun: yes\">&nbsp; <\/span>Becking says \u00ef\u00bf\u00bdThe<br \/>\nproposed methodology is discussed with regard to its applicability to essential<br \/>\ntrace elements. However, it should be applicable to all essential food<br \/>\ncomponents subject to homeostatic control by the human body.\u00ef\u00bf\u00bd <o:p><\/o:p><\/span><\/p>\n<p class=MsoBodyText><span style='font-size:12.0pt;font-family:\"Times New Roman\"'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/span><\/p>\n<p class=MsoFootnoteText><span class=MsoFootnoteReference><span\nstyle='font-size:12.0pt'>3<\/span><\/span><span style='font-size:12.0pt'> The<br \/>\ntext of the caveat, line 3 to the end, is from the Codex Guidelines on<br \/>\nNutrition Labeling <a\nhref=\"http:\/\/www.fao.org\/documents\/show_cdr.asp?url_file=\/DOCREP\/005\/Y2770E\/y2770e06.htm\">http:\/\/www.fao.org\/documents\/show_cdr.asp?url_file=\/DOCREP\/005\/Y2770E\/y2770e06.htm<\/a><o:p><\/o:p><\/span><\/p>\n<p class=MsoFootnoteText><span style='font-size:12.0pt'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/span><\/p>\n<p class=MsoFootnoteText><span style='font-size:12.0pt'>Text prepared by James<br \/>\nTurner, JD, Rima Laibow, MD and Ralph Fucetola, JD<o:p><\/o:p><\/span><\/p>\n<p class=MsoFootnoteText><span style='font-size:12.0pt'>10\/14\/05<o:p><\/o:p><\/span><\/p>\n<p><span style='font-size:11.0pt;font-family:\"Times New Roman\";mso-ansi-language:\nEN-US;mso-fareast-language:EN-US'><br clear=ALL style='page-break-before:always'><br \/>\n<\/span><\/p>\n<hr>\n<p><span style='font-size:11.0pt;font-family:\"Times New Roman\";mso-ansi-language:\nEN-US;mso-fareast-language:EN-US'><\/span><\/p>\n<p class=MsoNormal style='margin-left:.25in'><span style='font-size:11.0pt'>June<br \/>\n14, 2005<o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal><span style='font-size:11.0pt'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal style='margin-left:.25in'><span style='font-size:11.0pt'>To:<span\nstyle=\"mso-spacerun: yes\">&nbsp; <\/span>Dr. Edward Scarborough<o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal style='margin-left:.25in'><span style='font-size:11.0pt'>U.S.<br \/>\nCODEX Manager<o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal style='margin-left:.25in'><span style='font-size:11.0pt'>U.S.<br \/>\nCODEX Office<o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal style='margin-left:.25in'><span style='font-size:11.0pt'>United<br \/>\nStates Department of Agriculture<o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal style='margin-left:.25in'><span style='font-size:11.0pt'>South<br \/>\nBuilding, Room 4861<\/p>\n<p>1400 Independence Ave, SW<br \/>\nWashington, DC 20250<o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal><span style='font-size:11.0pt'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal><span style='font-size:11.0pt'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal align=center style='margin-left:.25in;text-align:center'><b>AMENDMENT<br \/>\nto CITIZEN PETITION<br \/>\nto U.S. CODEX Office for<o:p><\/o:p><\/b><\/p>\n<p class=MsoNormal align=center style='margin-left:.25in;text-align:center'><b>Adoption<br \/>\nof Dietary Supplement Harmonization Policy<o:p><\/o:p><\/b><\/p>\n<p class=MsoNormal align=center style='margin-left:.25in;text-align:center'><b>by<br \/>\nthe U.S. CODEX Delegation<br \/>\nin Harmony with DSHEA and 19 USC 3512<o:p><\/o:p><\/b><\/p>\n<p class=MsoNormal><span style='font-size:11.0pt'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='margin-left:.25in'>This AMENDMENT is submitted with<br \/>\nregard to the Citizen Petition of June 1, 2005, urging the US Codex Office to<br \/>\nadopt, as its policy, harmonization with international standards only in<br \/>\nconformity with existing US Law, further now stating:<\/p>\n<p class=MsoNormal><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='margin-left:.25in'>1.<span style=\"mso-spacerun:\nyes\">&nbsp; <\/span>The CODEX Vitamin and Mineral Standard uses inappropriate<br \/>\nscience (Risk Assessment procedures [toxicology] rather than nutritional<br \/>\nscience [biochemistry] to mandate maximum permissible levels of nutrients so<br \/>\nlow that they are, by intention, without impact on any human being; a Fact<br \/>\nHearing must be held to determine the scientifically factual basis for the use<br \/>\nof Risk Analysis in decisions pertaining to nutrition.<\/p>\n<p class=MsoNormal><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='margin-left:.25in'>The US Codex Office has accepted<br \/>\nthe use of Risk Assessment procedures for nutrients although Risk Assessment is<br \/>\na methodology relevant to toxicology and both irrelevant and antithetical to<br \/>\nnutritional science and biochemistry.<span style=\"mso-spacerun: yes\">&nbsp;<br \/>\n<\/span>Over the past many years, the United States has failed to oppose the use<br \/>\nof Risk Assessment techniques in the CODEX Committee on Nutrition and Foods for<br \/>\nSpecial Dietary Purposes and, since 1994, has failed to make its opposition to<br \/>\nthe use of Risk Analysis or any other attempt to limit access to nutrients<br \/>\nclear in order to prevent the restrictive, and, because of US law, the illegal<br \/>\nVitamin and Mineral Standard from moving forward via consensus to Step 8 in<br \/>\npreparation for ratification. <\/p>\n<p class=MsoNormal style='margin-left:.25in'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='margin-left:.25in'>The Technical Report discussing the<br \/>\napplication of Risk Assessment to nutrients<span class=MsoFootnoteReference> <\/span>makes<br \/>\nit clear that this procedure does not apply to nutrients because, unlike drugs,<br \/>\nthey have minimum intake limits which are required for life.<span\nstyle=\"mso-spacerun: yes\">&nbsp; <\/span>Risk Assessment procedures were<br \/>\nmodified without scientific validation or clinical testing.<span\nstyle=\"mso-spacerun: yes\">&nbsp; <\/span>Has the United States held a public<br \/>\nfact finding hearing to determine if this jerry-rigged statistical system has<br \/>\nany applicability to nutritional science?<span style=\"mso-spacerun: yes\">&nbsp;<\/p>\n<p><\/span>If not, why has the US supported the use of this technique in the nutritional<br \/>\ndeterminations made by the CCNFSDU when so many lives are at stake in this<br \/>\nissue?<span style=\"mso-spacerun: yes\">&nbsp; <\/span>Why has the US adopted this<br \/>\nscientifically factually indefensible policy which should not be abandoned in<br \/>\nfavor of a policy which supports and promotes DSHEA as the international<br \/>\nstandard?<\/p>\n<p class=MsoNormal><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='margin-left:.25in'>2.<span style=\"mso-spacerun:\nyes\">&nbsp; <\/span>The US Codex Office and all other involved agencies are<br \/>\nwithout legal authority to set, as was announced at the Public Hearing of June<br \/>\n9, 2005, as its Policy for the United States Government, and its Delegates to<br \/>\nthe 28<sup>th<\/sup> CAC meeting next month, a Policy which explicitly and<br \/>\nspecifically violates US law as set forth in the Natural Solutions Foundation\u00ef\u00bf\u00bds<br \/>\nCitizen\u00ef\u00bf\u00bds Petition presented to the US Codex Office on June 1, 2005:<\/p>\n<p class=MsoNormal style='margin-left:24.0pt'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='margin-left:.75in'>Title 19, Section 3512, forbids<br \/>\nthe US from harmonizing with standards which violate US law;<\/p>\n<p class=MsoNormal style='margin-left:60.0pt'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='margin-left:.75in'>The Dietary Supplement Health<br \/>\nEducation Act (DSHEA), 1994 classifies supplements as foods which therefore may<br \/>\nhave no Safe Upper Limits, Maximum Permissible Upper Limits or other<br \/>\nrestrictions upon their use.<\/p>\n<p class=MsoNormal><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal>The adoption of the Risk Assessment Model and the anti-DSHEA<br \/>\nharmonization Policy are <i>ultra vires<\/i><span style='font-style:normal'> and<br \/>\npremature; have occurred without sufficient Public Hearings and in direct<br \/>\ncontravention of the Public Policy of the United States as enacted by Congress.<\/span><\/p>\n<p class=MsoNormal style='margin-left:.25in'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='margin-left:.25in'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal><span style='font-size:11.0pt'>Dated:<span\nstyle=\"mso-spacerun: yes\">&nbsp; <\/span>June _____, 2005<o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal><span style='font-size:11.0pt'><b><span style='mso-tab-count:\n6'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>Natural<br \/>\nSolutions Foundation<o:p><\/o:p><\/b><\/span><\/p>\n<p class=MsoNormal>Cc:<o:p><\/o:p><\/p>\n<p class=MsoNormal>CODEX Office via facsimile and email<o:p><\/o:p><\/p>\n<p class=MsoNormal>George W. Bush, President<span style='font-size:11.0pt'><o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal>Secretary HHS<span style='font-size:11.0pt'><span\nstyle='mso-tab-count:4'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>___________________________________________<o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal>Secretary of Commerce<span style='font-size:11.0pt'><span\nstyle='mso-tab-count:3'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>Maj.<br \/>\nGen. Albert N. Stubblebine III (US Army, Ret.) <o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal>Secretary of Agriculture<span style='mso-tab-count:3'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span><span\nstyle='font-size:11.0pt'>President<span style='mso-tab-count:3'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span><o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal>Secretary of Transportation<span style='mso-tab-count:2'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span><o:p><\/o:p><\/p>\n<p class=MsoNormal>Commissioner of EPA<o:p><\/o:p><\/p>\n<p class=MsoNormal>Commissioner of FDA<span style='font-size:11.0pt'><span\nstyle='mso-tab-count:5'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span><o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal><span style='mso-tab-count:2'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span><span\nstyle='font-size:11.0pt'><span style='mso-tab-count:4'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>___________________________________________<o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal><span style='font-size:11.0pt'><span style='mso-tab-count:\n6'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>Rima<br \/>\nLaibow, MD<o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal><span style='font-size:11.0pt'><span style='mso-tab-count:\n6'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>Medical<br \/>\nDirector<o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal>Prepared by:<o:p><\/o:p><\/p>\n<p class=MsoNormal>Ralph Fucetola, JD<span style='mso-tab-count:4'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span><span\nstyle='font-size:11.0pt'>Natural Solutions Foundation<\/span><o:p><\/o:p><\/p>\n<p class=MsoNormal><span style='mso-tab-count:6'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span><span\nstyle='font-size:11.0pt'>POB 722<\/span><o:p><\/o:p><\/p>\n<p class=MsoNormal>Procedural Advisor: Jim Turner, JD<span style='mso-tab-count:\n2'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span><span\nstyle='font-size:11.0pt'>Maryville MO 64468<\/span><o:p><\/o:p><\/p>\n<p class=MsoNormal style='margin-left:.25in'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p><span style='font-size:11.0pt;font-family:\"Times New Roman\";mso-ansi-language:\nEN-US;mso-fareast-language:EN-US'><br clear=ALL style='page-break-before:always'><\/p>\n<p><\/span><\/p>\n<hr>\n<p><span style='font-size:11.0pt;font-family:\"Times New Roman\";mso-ansi-language:\nEN-US;mso-fareast-language:EN-US'><\/span><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><span\nstyle='color:black'>June 1, 2005 <o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><span\nstyle='color:black'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><span\nstyle='font-size:14.0pt;color:black'><b>To: Dr. Edward Scarborough <o:p><\/o:p><\/b><\/span><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><span\nstyle='font-size:14.0pt;color:black'>USDA<o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><span\nstyle='font-size:14.0pt;color:black'>U.S. CODEX Manager <o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><span\nstyle='font-size:14.0pt;color:black'>U.S. CODEX Office <o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><span\nstyle='font-size:14.0pt;color:black'>United States Department of Agriculture <o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><span\nstyle='font-size:14.0pt;color:black'>South Building, Room 4861 <o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><span\nstyle='font-size:14.0pt;color:black'>1400 Independence Ave, SW <o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><span\nstyle='font-size:14.0pt;color:black'>Washington, DC 20250 <o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><span\nstyle='color:black'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal align=center style='text-align:center;mso-layout-grid-align:\nnone;text-autospace:none'><span style='font-size:16.0pt;color:black'><b>CITIZEN<br \/>\nPETITION to U.S. CODEX Office for <o:p><\/o:p><\/b><\/span><\/p>\n<p class=MsoNormal align=center style='text-align:center;mso-layout-grid-align:\nnone;text-autospace:none'><span style='font-size:16.0pt;color:black'><b>Adoption<br \/>\nof Dietary Supplement Harmonization Policy <o:p><\/o:p><\/b><\/span><\/p>\n<p class=MsoNormal align=center style='text-align:center;mso-layout-grid-align:\nnone;text-autospace:none'><span style='font-size:16.0pt;color:black'><b>by the<br \/>\nU.S. CODEX Delegation in Harmony with DSHEA and 19 USC 3512 <o:p><\/o:p><\/b><\/span><\/p>\n<p class=MsoNormal align=center style='text-align:center;mso-layout-grid-align:\nnone;text-autospace:none'><span style='font-family:\"PBACLN+TimesNewRoman\\,Bold\";\ncolor:black'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><span\nstyle='color:black'><b><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/b><\/span><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><span\nstyle='color:black'><b>I. Introduction <o:p><\/o:p><\/b><\/span><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><span\nstyle='color:black'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><span\nstyle='color:black'>The Natural Solutions Foundation of POB 722, Maryville MO 64468 hereby PETITIONS the U.S. CODEX Office to adopt as the<br \/>\npolicy of the U.S. CODEX Delegation support for international harmonization<br \/>\nonly as it conforms to United States law and practice. This policy should be<br \/>\nadopted on an emergent basis, prior to the 28th General Sessions of the CODEX<\/p>\n<p>Commission scheduled for July 4-9, 2005 in Rome, Italy. This Petition is posted<br \/>\non the Internet at <u><a href=\"http:\/\/www.healthfreedomusa.org\/wp-content\/plugins\/url-cloak-encrypt\/url.php?id=aHR0cDovL3d3dy5IZWFsdGhGcmVlZG9tVVNBLm9yZy9wZXRpdGlvbg==\" >www.HealthFreedomUSA.org\/petition<\/a><br \/>\n.<o:p><\/o:p><\/u><\/span><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><span\nstyle='color:black'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><span\nstyle='color:black'>The Dietary Supplement industry has responded with growth<br \/>\nand expansion to substantial consumer demand since the adoption of the Dietary<br \/>\nHealth and Education Act of 1994 (DSHEA). Much of this growth may be attributed<br \/>\nto the Free Market in Dietary Supplements that was established by DSHEA. As<br \/>\nU.S. District Court Judge Tena Campbell stated in the Ephedra Decision last<br \/>\nmonth (Nutraceutical Corporation and Solaray, Inc. v. Lester Crawford, Acting<br \/>\nCommissioner, U.S. Food and Drug Administration, Case No. 2:04CV409 TC, USDC,<br \/>\nUtah Central Division), \u00ef\u00bf\u00bdthe legislative history of the DSHEA indicates that<br \/>\nCongress generally intended to harmonize the treatment of dietary supplements<br \/>\nwith that of foods when it added the dietary supplement subsection&#8230;\u00ef\u00bf\u00bd <o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><span\nstyle='color:black'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><span\nstyle='color:black'>At this point, many people in the industry, Health Freedom<br \/>\nAdvocates and consumers, fear that the CODEX ALIMENTARIUS process may, over<br \/>\ntime, reverse these positive developments. There is public perception and<br \/>\nconcern that international agencies are seeking to harmonize Dietary Supplement<br \/>\nregulations with restrictive rules and practices prevalent in certain countries<br \/>\noutside the United States, rather than with the Freedom of Access guaranteed by<br \/>\nDSHEA. Since most of the world\u00ef\u00bf\u00bds Dietary Supplement consumption and demand<br \/>\ntakes place in the United States, our law should be the basis for international<br \/>\nharmonization. <o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><span\nstyle='color:black'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><span\nstyle='color:black'>The CODEX Commission is scheduled to adopt standards<br \/>\nregarding Dietary Supplements at the July meeting that will lead to violations<br \/>\nof United States law and practice and therefore the U.S. CODEX Delegation<br \/>\nshould be instructed to vigorously oppose the adoption of such standards by<br \/>\nusing every legal means at their disposal to oppose such adoption. <o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><span\nstyle='color:black'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><span\nstyle='color:black'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><span\nstyle='color:black'><b>II. Action Requested <o:p><\/o:p><\/b><\/span><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><span\nstyle='color:black'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><span\nstyle='color:black'>The Petitioners urge the U.S. CODEX Office and all other<br \/>\nAgencies and government instrumentalities to adopt as the policy of the U.S.<br \/>\nCODEX Delegation and Agencies support only for international harmonization that<br \/>\nconforms to United States law and practice, at the 28th General Session of the <\/span>CODEX<br \/>\nALIMENTARIUS Commission, and in all further deliberations, considerations,<br \/>\nCODEX Committee and CODEX Commission policy positions, dealings and meetings<br \/>\ngoing forward from this time and specifically to: <o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='margin-left:.5in;mso-layout-grid-align:none;\ntext-autospace:none'>1. Reject any international standard that is inconstant<br \/>\nwith DSHEA or with 19 USC 3512, <o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='margin-left:.5in;mso-layout-grid-align:none;\ntext-autospace:none'>2. Support the Congressional determination that vitamins<br \/>\nand minerals are foods, not drugs or toxic chemicals, and, therefore, <o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='margin-left:.5in;mso-layout-grid-align:none;\ntext-autospace:none'>3. Support the use of nutritional science, a branch of<br \/>\nbiochemistry, not risk assessment science, a branch of toxicology, to determine<br \/>\noptimal levels, since toxicity is virtually unknown in nutrients but is part of<br \/>\nthe definition of a \u00ef\u00bf\u00bdtoxin.\u00ef\u00bf\u00bd Since optimal levels vary based on complex and<br \/>\ninterweaving factors such as age, diet, nutrient absorption, the presence or<br \/>\nabsence of co-factors, genetic makeup, underlying nutritional status, disease<br \/>\nstate, toxic burden and biochemical individuality, no maximum intake levels are<br \/>\nmeaningful for nutrients although they are highly significant for toxins. <o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='margin-left:.5in;mso-layout-grid-align:none;\ntext-autospace:none'>4. Support the biochemical reality embodied in DSHEA\u00ef\u00bf\u00bds<br \/>\nprotection of all supplements and categories of nutrients which the CODEX<br \/>\nVitamin and Mineral Standard violates when it states that the principal<br \/>\nnutritional value of foods comes from its vitamins and minerals. Exemplary and<br \/>\nabundant scientific and clinical evidence supports the importance of essential<br \/>\nfatty acids, oils, complex plant residues with physiological impact in foods,<br \/>\nflavinoids, antioxidants, amino acids and other vital factors, essential to<br \/>\nhealth, in food. These compounds are protected under DSHEA but ignored or<br \/>\nprevented from being part of the supplemental feeding list if a \u00ef\u00bf\u00bdPositive List\u00ef\u00bf\u00bd<br \/>\nis enacted by the CODEX ALIMENTARIUS Commission when it seeks to ratify the<br \/>\nvitamin and mineral standard this July in Rome. <o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='margin-left:.5in;mso-layout-grid-align:none;\ntext-autospace:none'>5. \u00ef\u00bf\u00bdTake Care that the Laws be faithfully executed\u00ef\u00bf\u00bd<br \/>\n(Article II, Section 3, United States Constitution) as established by DSHEA<br \/>\nthat, as foods, nutritional supplements do not require safe upper limits,<br \/>\nmaximum potencies, maximum permissible upper limits or similar constraints on<br \/>\ntheir use and that any such limits are antithetical to the legislative intent<br \/>\nand guarantees of DSHEA. <\/p>\n<p class=MsoNormal style='margin-left:.5in;mso-layout-grid-align:none;\ntext-autospace:none'><b><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/b><\/p>\n<p class=MsoNormal style='margin-left:.5in;mso-layout-grid-align:none;\ntext-autospace:none'><b><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/b><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><b>III.<br \/>\nStatement of Grounds <o:p><\/o:p><\/b><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='text-indent:.5in;mso-layout-grid-align:none;\ntext-autospace:none'><b>A. Factual Grounds <\/b><span style='font-weight:normal'><o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'>The<br \/>\n28th meeting of The CODEX ALIMENTARIUS Commission in Rome July 4-9, 2005, will<br \/>\nconsider adopting vitamin and mineral guidelines based on regulatory principles<br \/>\nthat may, over time limit access to dietary supplements of consumers in the<br \/>\nUnited States, and that could significantly restrict access to vitamin and<br \/>\nmineral supplements worldwide. <o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'>Based<br \/>\non public statements of the Chairman of the CODEX Committee on Nutrition and<br \/>\nFoods for Special Dietary Uses (CCNFSDU), Bonn, 2004, it is the intent and<br \/>\nunderstanding of that Committee (which has prepared the Vitamin and Mineral<br \/>\nStandard for ratification by the CODEX ALIMENTARIUS Commission in July, 20)<br \/>\nthat, despite the limited title of the proposed Standard, it will, because of<br \/>\nthe legal structure under which the CODEX ALIMENTARIUS Commission operates,<br \/>\nrestrict all classes of nutrients, not just those classed as Vitamins and<br \/>\nMinerals. <o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'>Ratification<br \/>\nby the CODEX ALIMENTARIUS Commission of the Vitamin and Mineral Standard as<br \/>\nproposed by CCNFSDU will amount to approving a blank check since the actual<br \/>\nlimits and specific items which it will restrict have not been specified or<br \/>\nproposed. The positions of decision makers on the CCNFSDU, which would have the<br \/>\nauthorization to select nutrients and levels without oversight or review once<br \/>\nthe Vitamin and Mineral Standard has been ratified, are antithetical to the use<br \/>\nof nutrients for the \u00ef\u00bf\u00bdprevention, treatment or cure of any disease or<br \/>\nconditions\u00ef\u00bf\u00bd and include the publicly stated position that \u00ef\u00bf\u00bdNutrition has no<br \/>\nplace in medicine\u00ef\u00bf\u00bd. These positions and trends are both antithetical to the<br \/>\nwill of the American people as expressed in their buying habits (i.e.,<br \/>\napproximately $20 billion in after-tax, unreimbursable dollars for supplements<br \/>\nin 2004) and in DSHEA. <o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'>This<br \/>\nsummer the Commission will meet to approve vitamin and mineral guidelines that<br \/>\nwere finalized by the CODEX Committee on Nutrition and Foods for Special<br \/>\nDietary Uses (CCNFSDU) in Bonn, Germany last November. These standards, as<br \/>\nnoted above, have neither specificity nor precision: the vitamin and mineral<br \/>\nstandard has no content and, if ratified, would not be subject to further<br \/>\nreview by a governing body and cannot be modified by countries like the United<br \/>\nStates whose laws it violates. If the Commission moves forward and approves<br \/>\nthese guidelines, CODEX will restrict access to vitamins and minerals in<br \/>\nseveral ways: <o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='margin-left:.5in;mso-layout-grid-align:none;\ntext-autospace:none'>1. Setting upper safe limits (maximum potencies, maximum<br \/>\npermissible upper limits or similar limitations) for each vitamin and mineral<br \/>\nbased on inappropriate scientific risk assessment from the science of<br \/>\ntoxicology, not the science of nutrition; this violates scientific sense and<br \/>\nclinical experience. \u00ef\u00bf\u00bdOptimum levels\u00ef\u00bf\u00bd are a much more reasonable, clinically<br \/>\nand scientifically supported standard and must be individually determined for<br \/>\neach individual. <o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='margin-left:.5in;mso-layout-grid-align:none;\ntext-autospace:none'>2. Setting any upper limits on supplements and nutrients;<\/p>\n<p>this violates the legislative intent and provisions of DSHEA that Dietary<br \/>\nSupplements are Foods, not Drugs. <o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='margin-left:.5in;mso-layout-grid-align:none;\ntext-autospace:none'>3. Marginalizing the nutrient supplement possibilities for<br \/>\nthe nearly 1 billion people worldwide, who, by international standards and the<br \/>\nassessments of the World Health Organization and the Food and Agriculture<br \/>\nOrganization, now experience devastating widespread under nutrition and go<br \/>\nhungry. In addition, the population-based CODEX standards under-appreciate the<br \/>\nnutritional status of the world\u00ef\u00bf\u00bds remaining 4.6 billion people, a majority of<br \/>\nwhom lack the recommended amount of one or more essential nutrient. <o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='margin-left:.5in;mso-layout-grid-align:none;\ntext-autospace:none'>4. Creating, through setting maximum vitamin and mineral<br \/>\nconsumption limits, an approach to regulating dietary supplements which is<br \/>\nconsistent with and leading the way toward, if not itself directly<br \/>\nestablishing, prior restraint. <o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='margin-left:.5in;mso-layout-grid-align:none;\ntext-autospace:none'>5. Narrowing substantially the amount of nutrition and<br \/>\nhealth information about vitamins and minerals consumers will be allowed to<br \/>\nreceive, asserting that only drugs can contain label claims for products that<br \/>\nare suitable for the prevention, alleviation, treatment or cure of disease,<br \/>\ndisorder or particular physiological conditions; this violates the Right of<br \/>\nFree Speech guaranteed by the First Amendment. <o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='margin-left:.5in;mso-layout-grid-align:none;\ntext-autospace:none'>6. Fostering the worldwide health assumption that<br \/>\nsufficient levels of nutrients can be found in a regular diet; this is<br \/>\nunsupported by an abundant body of scientific literature and clinical<br \/>\nexperience as well as the repeated findings of international organizations like<br \/>\nthe World Health Organization, UNESCO and the Food and Agriculture<br \/>\nOrganization. <o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'>Natural<br \/>\nhealth consumers are becoming active and organized to protect and expand their<br \/>\nhealth rights. Worldwide health could be significantly undermined by the<br \/>\nCODEX-created limits to nutrients available in many countries according to<br \/>\nofficial documents prepared jointly by the World Health Organization and the<br \/>\nFood and Agriculture Organization. Codex, by itself, may change U.S. laws.<br \/>\nCodex&#8217;s upper potency limits, established for vitamins and minerals, may<br \/>\nrestrict U.S. consumer access to high-potency vitamins and minerals to which<br \/>\nthey are accustomed. U.S. companies may choose to \u00ef\u00bf\u00bddumb down\u00ef\u00bf\u00bd their potencies<br \/>\nto mirror their international formulations. <o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'>CODEX<br \/>\nALIMENTARIUS standards and guidelines are enforced at the international level<br \/>\nvia trade sanctions imposed by the World Trade Organization (WTO) through its<br \/>\ndispute resolution process. However, there is grave concern in many quarters,<br \/>\nincluding an opinion created by the Congressional Research Service for two<br \/>\nmembers of Congress, that because of the Sanitary and Phytosanitary Agreement,<br \/>\nArticle 3, it shall be incumbent upon each member nation of the WTO to bring<br \/>\nits domestic standards into conformity with CODEX standards and guidelines in<br \/>\norder to avoid the creation of a hidden barrier to international trade. This<br \/>\nwould be in clear violation of both DSHEA and with 19 USC 3512. CODEX<br \/>\nmisapplies an inappropriate toxic chemicals risk assessment model to regulate<br \/>\nhelpful nutrients which have virtually no established toxicity and therefore,<br \/>\npresent virtually no consumer danger. Although any assessment of vitamin and<br \/>\nmineral usage should evaluate nutrients using nutritional science rather than<br \/>\nwith the toxicological science used to evaluate toxin and dangerous industrial<br \/>\nchemicals, since supplements, including vitamins and minerals, are defined as<br \/>\nfoods under DSHEA, upper limits of any type are inappropriate and should be<br \/>\nopposed by the United States with vigor both in CODEX meetings and otherwise. <o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'>The<br \/>\nhuman body is able to rid itself of excess doses of nutrients or store them for<br \/>\nfuture use in times of shortfall, whereas it is not able to rid itself<br \/>\nadequately of toxic and dangerous chemicals. This difference, coupled with<br \/>\ndifferential impact of nutrients and detrimental impact of toxins, is precisely<br \/>\nthe distinction upon which the determination that the latter are, in fact,<br \/>\ntoxic while the former are clearly non-toxic. The CODEX Vitamin and Mineral<br \/>\nStandard disregards the unique biological individuality which determines the<br \/>\nbasic nutritional needs of each individual. <o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'>Biological<br \/>\nrequirements can vary widely (by orders of magnitude) during the life span<br \/>\nsince nutritional requirements are affected by climate, dietary supply,<br \/>\ngenetics, energy output, toxic load, emotional, organ and immune health,<br \/>\nelectromagnetic and geopathic stress as well as normal and pathological aging<br \/>\nprocesses and enzymatic decline with aging. CODEX disregards this and all other<br \/>\nshort and long term biological individuality. CODEX fails in this fundamental<br \/>\nrequirement by erroneously disregarding biological, physiological and<br \/>\npathophysiologic variation in nutrient needs. CODEX documents make it clear<br \/>\nthat the process of risk assessment does not properly apply to nutrients and<br \/>\nthat the process must be modified to account for the differences between<br \/>\nnutrients and toxins. The procedures employed to accomplish that modification<br \/>\nare untested through scientific or clinical evaluations and are entirely<br \/>\ntheoretical. Their impact upon the earth\u00ef\u00bf\u00bds population, however, will be<br \/>\npractical and devastating. CODEX also fails in this fundamental requirement by<br \/>\nerroneously applying toxic chemical risk assessment principles to nutrients<br \/>\nwhich are foods, not toxins, erroneously asserting that <o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='margin-left:.5in;text-indent:-.25in;mso-list:l0 level1 lfo4;\nmso-layout-grid-align:none;text-autospace:none'><![if !supportLists]><span\nstyle='font:7.0pt \"Times New Roman\"'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<br \/>\n<\/span><![endif]>1. Nutrients should be treated and evaluated as toxins. <o:p><\/o:p><\/p>\n<p class=MsoNormal style='margin-left:.5in;text-indent:-.25in;mso-list:l0 level1 lfo4;\nmso-layout-grid-align:none;text-autospace:none'><![if !supportLists]><span\nstyle='font:7.0pt \"Times New Roman\"'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<br \/>\n<\/span><![endif]><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='margin-left:.5in;text-indent:-.25in;mso-list:l0 level1 lfo4;\nmso-layout-grid-align:none;text-autospace:none'><![if !supportLists]><span\nstyle='font:7.0pt \"Times New Roman\"'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<br \/>\n<\/span><![endif]>2. Such evaluation requires new and untested procedures whose<br \/>\naccuracy and utility have not been evaluated through appropriate studies and<br \/>\ntrials. <o:p><\/o:p><\/p>\n<p class=MsoNormal style='margin-left:.5in;text-indent:-.25in;mso-list:l0 level1 lfo4;\nmso-layout-grid-align:none;text-autospace:none'><![if !supportLists]><span\nstyle='font:7.0pt \"Times New Roman\"'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<br \/>\n<\/span><![endif]><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='margin-left:.5in;text-indent:-.25in;mso-list:l0 level1 lfo4;\nmso-layout-grid-align:none;text-autospace:none'><![if !supportLists]><span\nstyle='font:7.0pt \"Times New Roman\"'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<br \/>\n<\/span><![endif]>3. Supplements, including vitamins and minerals are toxins,<br \/>\nnot foods, and therefore require upper limits on ingestion <o:p><\/o:p><\/p>\n<p class=MsoNormal style='margin-left:.5in;text-indent:-.25in;mso-list:l0 level1 lfo4;\nmso-layout-grid-align:none;text-autospace:none'><![if !supportLists]><span\nstyle='font:7.0pt \"Times New Roman\"'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<br \/>\n<\/span><![endif]><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='margin-left:.5in;text-indent:-.25in;mso-list:l0 level1 lfo4;\nmso-layout-grid-align:none;text-autospace:none'><![if !supportLists]><span\nstyle='font:7.0pt \"Times New Roman\"'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<br \/>\n<\/span><![endif]>4. Foods and nutrients are not useful in treating disease. <o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='margin-left:.5in;text-indent:-.25in;mso-list:l0 level1 lfo4;\nmso-layout-grid-align:none;text-autospace:none'><![if !supportLists]><span\nstyle='font:7.0pt \"Times New Roman\"'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<\/p>\n<p><\/span><![endif]>5. Supplements have little value because people can get the<br \/>\nlimited amounts they need from food. <o:p><\/o:p><\/p>\n<p class=MsoNormal style='margin-left:.5in;text-indent:-.25in;mso-list:l0 level1 lfo4;\nmso-layout-grid-align:none;text-autospace:none'><![if !supportLists]><span\nstyle='font:7.0pt \"Times New Roman\"'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<br \/>\n<\/span><![endif]><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='margin-left:.5in;text-indent:-.25in;mso-list:l0 level1 lfo4;\nmso-layout-grid-align:none;text-autospace:none'><![if !supportLists]><span\nstyle='font:7.0pt \"Times New Roman\"'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<br \/>\n<\/span><![endif]>6. The nutritional quality of foods is due primarily to the<br \/>\nvitamin and mineral content of those foods. <o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='margin-left:.5in;text-indent:-.25in;mso-list:l0 level1 lfo4;\nmso-layout-grid-align:none;text-autospace:none'><![if !supportLists]><span\nstyle='font:7.0pt \"Times New Roman\"'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<br \/>\n<\/span><![endif]>7. Rigid, low limits should be set for vitamins and nutrients<br \/>\nbecause nutritional requirements do not change with biochemical, age-related,<br \/>\ngenetic and other assaults and do not vary from person to person, despite<br \/>\nabundantly documented genetic and environmental variations within and between populations.<br \/>\n<o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='margin-left:.5in;text-indent:-.25in;mso-list:l0 level1 lfo4;\nmso-layout-grid-align:none;text-autospace:none'><![if !supportLists]><span\nstyle='font:7.0pt \"Times New Roman\"'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<br \/>\n<\/span><![endif]>8. Theoretical reference values are more important than unique<br \/>\nindividual nutrient needs and clinical requirements. <o:p><\/o:p><\/p>\n<p class=MsoNormal style='margin-left:.5in;text-indent:-.25in;mso-list:l0 level1 lfo4;\nmso-layout-grid-align:none;text-autospace:none'><![if !supportLists]><span\nstyle='font:7.0pt \"Times New Roman\"'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<br \/>\n<\/span><![endif]><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='margin-left:.5in;text-indent:-.25in;mso-list:l0 level1 lfo4;\nmso-layout-grid-align:none;text-autospace:none'><![if !supportLists]><span\nstyle='font:7.0pt \"Times New Roman\"'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<br \/>\n<\/span><![endif]>9. Toxicology science is preferred to individual choice as the<br \/>\nbest control on access to foods such as Dietary Supplements. <o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='margin-left:.5in;text-indent:-.25in;mso-list:l0 level1 lfo4;\nmso-layout-grid-align:none;text-autospace:none'><![if !supportLists]><span\nstyle='font:7.0pt \"Times New Roman\"'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<br \/>\n<\/span><![endif]>10. Dietary supplements require control on access despite the<br \/>\nfact that they are foods under DSHEA. <o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='margin-top:5.0pt;margin-right:0in;margin-bottom:5.0pt;\nmargin-left:0in;mso-layout-grid-align:none;text-autospace:none'><span\nstyle='font-size:10.0pt'>The well documented safety of Dietary Supplements, as<br \/>\nfoods, is documented by <u>La Leva di Archimede <\/u>at <u><a\nhref=\"http:\/\/www.laleva.cc\/petizione\/english\/ronlaw_eng.html\">http:\/\/www.laleva.cc\/petizione\/english\/ronlaw_eng.html<\/a><span\nstyle=\"mso-spacerun: yes\">&nbsp; <\/span><\/u>(with particular reference to <u><a\nhref=\"http:\/\/www.laleva.cc\/petizione\/ron_law_tables\/tabella.html\">http:\/\/www.laleva.cc\/petizione\/ron_law_tables\/tabella.html<\/a><br \/>\n<\/u>, <u><a\nhref=\"http:\/\/www.laleva.cc\/petizione\/ronlaw\/australia_societal_vs_individual_risks2.pdf\">http:\/\/www.laleva.cc\/petizione\/ronlaw\/australia_societal_vs_individual_risks2.pdf<\/a><br \/>\n<\/u>, <u><a href=\"http:\/\/www.healthfreedomusa.org\/wp-content\/plugins\/url-cloak-encrypt\/url.php?id=aHR0cDovL3d3dy5sYWxldmEuY2Mvc3VwcGxlbWVudHMvbWVkaWNhbF9pbmp1cnlfbGF3LnBkZg==\" >http:\/\/www.laleva.cc\/supplements\/medical_injury_law.pdf<\/a><\/p>\n<p><\/u>, <u><a\nhref=\"http:\/\/www.laleva.cc\/petizione\/ronlaw\/leape_relative%20risks1.pdf\">http:\/\/www.laleva.cc\/petizione\/ronlaw\/leape_relative%20risks1.pdf<\/a><br \/>\n<\/u>, <u><a\nhref=\"http:\/\/www.laleva.cc\/petizione\/ronlaw\/relative_risk_boeing72.pdf\">http:\/\/www.laleva.cc\/petizione\/ronlaw\/relative_risk_boeing72.pdf<\/a><\/u><br \/>\n<u><a href=\"http:\/\/www.healthfreedomusa.org\/wp-content\/plugins\/url-cloak-encrypt\/url.php?id=aHR0cDovL3d3dy5sYWxldmEuY2MvcGV0aXppb25lL3Jvbmxhdy9yZWxhdGl2ZV9yaXNrc19idWJibGVzMy5wZGY=\" >http:\/\/www.laleva.cc\/petizione\/ronlaw\/relative_risks_bubbles3.pdf<\/a><br \/>\n<\/u>) and Dr. Andrew Saul\u00ef\u00bf\u00bds presentation to the Canadian Parliament, \u00ef\u00bf\u00bd<i>Where<br \/>\nAre The Bodies<\/i><\/span><span style='font-size:10.0pt'>?\u00ef\u00bf\u00bd, <u><a\nhref=\"http:\/\/www.doctoryourself.com\/testimony.htm\">http:\/\/www.doctoryourself.com\/testimony.htm<\/a><\/u>.<br \/>\n<o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'>CODEX<br \/>\nreinforces, in its vitamin and mineral guidelines, its existing prohibition on<br \/>\npreventing truthful information about the ability of foods and nutrients to<br \/>\ntreat, diagnose, prevent, mitigate and cure disease. CODEX prohibits<br \/>\nsupplemental nutritional feeding world wide, and the dissemination of<br \/>\ninformation on the positive impact of nutritional supplementation and support<br \/>\non chronic, degenerative disease. CODEX rejects without scientific basis or<br \/>\nsupport the position supporting access to nutrients strongly documented and<br \/>\nendorsed by joint publications of the World Health Organization and the Food<br \/>\nand Agriculture Organization which detail the contribution of nutrition to the<br \/>\nprevention and treatment of chronic diseases in both the developing and<br \/>\ndeveloped world. World hunger experts recognize that nutrient supplementation<br \/>\ncan be extraordinarily useful in improving world health and eliminating disease<br \/>\n(vitamin A supplements in developing countries can offer 30 times as much<br \/>\nsocial improvement as $1 of development aid), a fact CODEX vitamin and mineral<br \/>\nguidelines ignore without scientific support for their position. <o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'>CODEX<br \/>\nignores, in its vitamin and mineral guidelines, the high costs in loss of life,<br \/>\ndegraded quality of life and economic loss created by the chronic diseases of<br \/>\nnutrient-deficiency although they are abundantly documented in clinical,<br \/>\nbiochemistry and epidemiological literature. The human and economic impact and<br \/>\ncosts of under nutrition are recognized by the World Health Organization and<br \/>\nthe Food and the Food and Agriculture Organization who document that chronic<br \/>\ndisease (e.g., heart disease and stroke, diabetes, obesity, cancer, etc.) is a<br \/>\nnon-contagious epidemic problem which can be prevented, treated and cured only<br \/>\nthrough adequate nutrition. They further document that nutrition cannot always<br \/>\nbe provided by diet. Clinically necessary nutrient intake is, however,<br \/>\nprohibited under the proposed CODEX vitamin and mineral standard. <o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'>The<br \/>\nUnited States Supreme Court has spoken forcefully, enforcing consumers\u00ef\u00bf\u00bd right<br \/>\nto truthful information about health care issues. See: Thompson v Western<br \/>\nStates Medical Centers, where Justice O\u00ef\u00bf\u00bdConnor wrote, <o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'>&quot;If<br \/>\nthe First Amendment means anything, it means that regulating speech must be a<br \/>\nlast &#8211; not first &#8211; resort. . . We have previously rejected the notion that the<br \/>\nGovernment has an interest in preventing the dissemination of truthful<br \/>\ncommercial information in order to prevent members of the public from making<br \/>\nbad decisions with the information. . . Even if the Government did argue that<br \/>\nit had an interest in preventing misleading advertisements, this interest could<br \/>\nbe satisfied by the far less restrictive alternative of requiring . . . a<br \/>\nwarning that . . . its risks were unknown.&quot; <o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'>The<br \/>\nbasic rule, announced by the case, to determine constitutionally permitted<br \/>\ngovernment restrictions on Commercial Speech (speech that makes or is about an<br \/>\noffer for a transaction, such as the sale of Dietary Supplements) is a Two<br \/>\nProng Test: the first prong is to ask two questions: (1) is the speech in<br \/>\nquestion about unlawful activity and (2) is the speech misleading. If<br \/>\n&quot;no&quot; to both, the speech is entitled to protection unless the<br \/>\nGovernment can carry its burden and prove (1) the governmental interest<br \/>\ninvolved is &quot;substantial&quot;, (2) the regulation must &quot;directly<br \/>\nadvance&quot; the governmental interest and (3) the regulation of Commercial<br \/>\nSpeech cannot be &quot;more extensive than is necessary to serve that<br \/>\ninterest&quot; (quoting Central Hudson v Public Service, 447 US 557, at 566). <o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'>We<br \/>\nsubmit that the standards proposed for adoption at the 28th General Session<br \/>\ncannot withstand legal scrutiny under the Supreme Court Test. <o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='text-indent:.5in;mso-layout-grid-align:none;\ntext-autospace:none'><b>B. Legal Authority <\/b><span style='font-weight:normal'><o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'>1.<br \/>\nThe Legal Basis for this Petition is the First Amendment to the Constitution of<br \/>\nthe United States: \u00ef\u00bf\u00bdCongress shall make no law . . . abridging the . . . the<br \/>\nright of the people . . .to petition the Government for a redress of<br \/>\ngrievances.\u00ef\u00bf\u00bd <o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'>2.<br \/>\nThe Legal Basis for the Proposed Policy is Section 3512 of Title 19 and<br \/>\nspecifically, 19 USC 3512(a)(1) and (a)(2) as applied to the protection of<br \/>\nhuman life through DSHEA. <o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'>Section<br \/>\n3512. Relationship of agreements to United States law and State law <o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='text-indent:.5in;mso-layout-grid-align:none;\ntext-autospace:none'><span style='font-size:11.0pt'>(a) Relationship of<br \/>\nagreements to United States law <o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal style='text-indent:.5in;mso-layout-grid-align:none;\ntext-autospace:none'><span style='font-size:11.0pt'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal style='margin-left:1.0in;mso-layout-grid-align:none;\ntext-autospace:none'><span style='font-size:11.0pt'>(1) United States law to<br \/>\nprevail in conflict. No provision of any of the Uruguay Round Agreements, nor<br \/>\nthe application of any such provision to any person or circumstance, that is<br \/>\ninconsistent with any law of the United States shall have effect. <o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal style='margin-left:1.0in;text-indent:.5in;mso-layout-grid-align:\nnone;text-autospace:none'><span style='font-size:11.0pt'>(2) Construction:<br \/>\nNothing in this Act shall be construed &#8211; <o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal style='margin-left:2.0in;mso-layout-grid-align:none;\ntext-autospace:none'><span style='font-size:11.0pt'>(A) to amend or modify any<br \/>\nlaw of the United States, including any law relating to &#8211; <o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal style='margin-left:2.0in;text-indent:.5in;mso-layout-grid-align:\nnone;text-autospace:none'><span style='font-size:11.0pt'>(i) the protection of<br \/>\nhuman, animal, or plant life or health, <o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal style='margin-left:2.0in;text-indent:.5in;mso-layout-grid-align:\nnone;text-autospace:none'><span style='font-size:11.0pt'>(ii) the protection of<br \/>\nthe environment, or <o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal style='margin-left:2.0in;text-indent:.5in;mso-layout-grid-align:\nnone;text-autospace:none'><span style='font-size:11.0pt'>(iii) worker safety,<br \/>\nor <o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal style='margin-left:2.0in;mso-layout-grid-align:none;\ntext-autospace:none'><span style='font-size:11.0pt'>(B) to limit any authority<br \/>\nconferred under any law of the United States, including section 2411 of this<br \/>\ntitle, unless specifically provided for in this Act. <o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal style='margin-left:2.0in;mso-layout-grid-align:none;\ntext-autospace:none'><span style='font-size:11.0pt'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'>3.<br \/>\nAdditionally, the Statutes authorizing the Department contain general provisions<br \/>\nthat support the actions requested in this petition. Federal Law includes<br \/>\nprovisions that grant the Secretary broad authority to promulgate rules and regulations<br \/>\n\u00ef\u00bf\u00bdnecessary to carry out the Act[s].\u00ef\u00bf\u00bd <o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'>4.<br \/>\nThe Office Should Promulgate the Requested Policy as an Interim Final Rule<br \/>\nWithout<span style=\"mso-spacerun: yes\">&nbsp; <\/span>First Completing Notice<br \/>\nand Comment, Risk Assessment, and Cost-Benefit Analysis <o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'>Under<br \/>\nordinary circumstances, the agency must comply with procedural requirements<br \/>\nunder both the Administrative Procedures Act (APA) and the USDA Reorganization<br \/>\nAct of 1994, including the use of notice-and-comment rulemaking and the<br \/>\ncompletion of a risk assessment and cost-benefit analysis before issuance of a<br \/>\nnew rule. However, both acts provide for exceptions to those requirements for<br \/>\ncircumstances such as those present here, where the new international<br \/>\nregulations would constitute an imminent threat to public safety and any delay<br \/>\nin policy making would be contrary to the public interest. <o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'>The<br \/>\nOffice should avail itself of those statutory exceptions and promulgate the<br \/>\nrequested policies without first providing the public with notice and an<br \/>\nopportunity for comment and before completing a full risk assessment and<br \/>\ncost-benefit analysis. The agency should first adopt the policy as an<br \/>\n&quot;interim-final rule,&quot; which would become binding upon publication (or<br \/>\nshortly thereafter), and subsequently provide for public comment and complete<br \/>\nits risk assessment and cost-benefit analysis. As explained below, the Office<br \/>\nis authorized to take such an approach under the USDA Reorganization Act of<br \/>\n1994. <o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='margin-left:.5in;mso-layout-grid-align:none;\ntext-autospace:none'>a. The Requested Regulations Satisfy the &quot;Good<br \/>\nCause&quot; Exception to the Administrative Procedure Act&#8217;s Requirement for<br \/>\nNotice and Comment. <o:p><\/o:p><\/p>\n<p class=MsoNormal style='margin-left:.5in;mso-layout-grid-align:none;\ntext-autospace:none'>The APA provides that full notice-and-comment rulemaking<br \/>\nis not required when an agency &quot;for good cause finds (and incorporates the<br \/>\nfinding and a brief statement of the reasons therefore in the rules issued)<br \/>\nthat notice and public procedure thereon are impracticable, unnecessary, or<br \/>\ncontrary to the public interest.&quot; 5 U.S.C. \u00ef\u00bf\u00bd553(b)(B). The good cause<br \/>\nexception &quot;is an important safety valve to be used where delay would do<br \/>\nreal harm.&quot; United States Steel v. EPA, 595 F.2d 207, 214 (5th Cir. 1979).<br \/>\nAccording to the legislative history of the provision, &quot;&#8217;impracticable&#8217;<br \/>\nmeans a situation in which the due and required execution of the agency<br \/>\nfunctions would be unavoidably prevented by its undertaking public rule-making<br \/>\nproceedings.&quot; S. Rep. No. 752, 79th Cong., 1st Sess., at 16 (1945). As one<br \/>\ncourt has held, determining &quot;impracticality&quot; requires &quot;analysis<br \/>\nin practical terms of the particular statutory-agency setting and the reasons<br \/>\nwhy agency action could not await notice and comment.&quot; American Transfer<\/p>\n<p>&amp; Storage Company v. ICC, 719 F.2d 1283, 1295 (5th Cir. 1983). <o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='margin-left:.5in;mso-layout-grid-align:none;\ntext-autospace:none'>There are numerous instances in which courts have upheld<br \/>\nan agency&#8217;s decision to invoke the &quot;good cause&quot; exception and issue a<br \/>\nrule without providing for notice and comment where a delay would threaten<br \/>\npublic safety or the environment. See, e.g., Hawaii Helicopter Operators Ass&#8217;n<br \/>\nv. FAA, 51 F.3d 212, 214 (9th Cir. 1995) (good cause exception satisfied in<br \/>\nview of &quot;the threat to public safety reflected in an increasing number of<br \/>\nhelicopter accidents&quot;); Northern Arapahoe Tribe v. Hodel, 808 F.2d 741,<br \/>\n750-52 (10th Cir. 1987) (good cause exception satisfied in view of urgent need<br \/>\nfor hunting regulations where herds were threatened with extinction); Northwest<br \/>\nAirlines-v. Goldschmidt, 645 F.2d 1309, 1321 (8th Cir. 1981) (good cause<br \/>\nexception satisfied in view of urgent need to allocate landing slots at major<br \/>\nairport). <o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='margin-left:.5in;mso-layout-grid-align:none;\ntext-autospace:none'>The rationale underlying those decisions, that compliance<br \/>\nwith time-consuming procedural requirements would \u00ef\u00bf\u00bddo real harm\u00ef\u00bf\u00bd by delaying<br \/>\nimplementation of urgently needed policies to safeguard public health, is<br \/>\nequally applicable here, where international regulations in derogation of<br \/>\nUnited States Law and practice will have a negative impact on U.S. consumers.<br \/>\nClearly, the exigent circumstances necessary to satisfy the APA&#8217;s good cause<br \/>\nexception are present. <o:p><\/o:p><\/p>\n<p class=MsoNormal style='margin-left:.5in;mso-layout-grid-align:none;\ntext-autospace:none'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='margin-left:.5in;mso-layout-grid-align:none;\ntext-autospace:none'>b. The Requested Regulations Present a Situation In Which<br \/>\nRegulatory Analysis is &quot;Not Practicable Because of Compelling<br \/>\nCircumstances&quot; Under the U.S. Department of Agriculture Reorganization Act<br \/>\nof 1994. <o:p><\/o:p><\/p>\n<p class=MsoNormal style='margin-left:.5in;mso-layout-grid-align:none;\ntext-autospace:none'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='margin-left:.5in;mso-layout-grid-align:none;\ntext-autospace:none'>Under \u00ef\u00bf\u00bd 2204e of the USDA Reorganization Act of 1994, USDA<br \/>\nmust complete a risk assessment and cost-benefit analysis for each proposed<br \/>\nmajor regulation that relates to human health, safety, or the environment. 7 U.S.C.<br \/>\n\u00ef\u00bf\u00bd 2204e. That section does provide an exception, however: when a risk<br \/>\nassessment and cost-benefit analysis is &quot;not practicable because of<br \/>\ncompelling circumstances,&quot; an explanation can be provided in lieu of a<br \/>\nfull analysis. Id. at \u00ef\u00bf\u00bd 2204e (b)(1). The compelling circumstances here are the<br \/>\nimminent adoption of international standards in derogation of United States Law<br \/>\nand practice. <o:p><\/o:p><\/p>\n<p class=MsoNormal style='margin-left:.5in;mso-layout-grid-align:none;\ntext-autospace:none'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><b><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/b><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><b><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/b><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><b><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/b><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><b>III.<br \/>\nConclusion <o:p><\/o:p><\/b><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'>Codex&#8217;s<br \/>\nrestrictive vitamin and mineral guideline should be replaced by the U.S.<br \/>\nDietary Supplement Health Education Act (DSHEA) food-based standard as the<br \/>\ninternational standard for vitamin, minerals and all other dietary supplements.<br \/>\nThe DSHEA, passed unanimously by the U.S. Congress in 1994, recognizes and<br \/>\nprotects the value of individuals making personal nutritional and health<br \/>\nchoices in a way that is rejected by the CODEX guidelines. Any attempt to<br \/>\nrestrict or limit dosages, potency, information or access to supplements<br \/>\ndenigrates their classification under DSHEA as foods and, hence, without need<br \/>\nfor access restriction. <o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'>The<br \/>\nculmination of 50 years of U.S. legislation and litigation has refined the<br \/>\nsupplement policy of the United States ensuring that individual choice and<br \/>\ndesire play a key role in ensuring private and public health. The CODEX<br \/>\nguideline subordinates individual choice to scientifically inaccurate and<br \/>\nunsupported, supposed professional expertise. The DSHEA balances professionals,<br \/>\nscience and people. <o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'>Members<br \/>\nof the public have continually warned United States policy makers that pending<br \/>\ninternational regulations fail to meet both the standards of United States law<br \/>\nand the requirements of the international law. <o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><span\nstyle='font-size:10.0pt'>See for example, Public Citizen\u00ef\u00bf\u00bds comments regarding<br \/>\nharmonization: <u><a\nhref=\"http:\/\/www.citizen.org\/trade\/harmonization\/comments\/articles.cfm?ID=4394\">http:\/\/www.citizen.org\/trade\/harmonization\/comments\/articles.cfm?ID=4394<\/a><span\nstyle=\"mso-spacerun: yes\">&nbsp; <\/span><\/u>and the National Health Federation,<br \/>\n\u00ef\u00bf\u00bdCODEX Breaks its own Rules\u00ef\u00bf\u00bd <u><a\nhref=\"http:\/\/www.thenhf.com\/codex_may_2005_nhf_press_release.htm\">http:\/\/www.thenhf.com\/codex_may_2005_nhf_press_release.htm<\/a><span\nstyle=\"mso-spacerun: yes\">&nbsp; <\/span><\/u><o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><span\nstyle='font-size:10.0pt'>Also see the European Alliance for Natural Health<br \/>\nSubmission on Risk Assessment at: <o:p><\/o:p><\/span><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><span\nstyle='font-size:10.0pt'><u><a\nhref=\"http:\/\/www.alliance-natural-health.org\/_docs\/ANHwebsiteDoc_120.pdf\">http:\/\/www.alliance-natural-health.org\/_docs\/ANHwebsiteDoc_120.pdf<\/a><span\nstyle=\"mso-spacerun: yes\">&nbsp; <\/span><o:p><\/o:p><\/u><\/span><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'>The<br \/>\nPetitioners urge the U.S. CODEX Office to adopt as the policy of the U.S. CODEX<br \/>\nDelegation support only for international harmonization that conforms to United<br \/>\nStates law and practice, and specifically the provisions of DSHEA through 19<br \/>\nUSC 3512, \u00ef\u00bf\u00bdUnited States law to prevail in conflict.<span style=\"mso-spacerun:\nyes\">&nbsp; <\/span>No provision of any of the Uruguay Round Agreements, nor the<br \/>\napplication of any such provision to any person or circumstance, that is inconsistent<br \/>\nwith any law of the United States shall have effect.\u00ef\u00bf\u00bd <o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'>Dated:<br \/>\nJune _____, 2005 <o:p><\/o:p><\/p>\n<p class=MsoNormal style='margin-left:2.5in;text-indent:.5in;mso-layout-grid-align:\nnone;text-autospace:none'><b><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/b><\/p>\n<p class=MsoNormal style='margin-left:2.5in;text-indent:.5in;mso-layout-grid-align:\nnone;text-autospace:none'><b><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/b><\/p>\n<p class=MsoNormal style='margin-left:2.5in;text-indent:.5in;mso-layout-grid-align:\nnone;text-autospace:none'><b>Natural Solutions Foundation <o:p><\/o:p><\/b><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'>Cc: <o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'>CODEX<br \/>\nOffice via facsimile and email <o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'>George<br \/>\nW. Bush, President <o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'>Secretary<br \/>\nHHS <span style='mso-tab-count:4'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>____________________________________<br \/>\n<o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'>Secretary<br \/>\nof Agriculture<span style='mso-tab-count:2'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span><br \/>\n<span style='mso-tab-count:1'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>Maj.<br \/>\nGen. Albert N. Stubblebine III<span style='mso-tab-count:2'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><span\nstyle=\"mso-spacerun: yes\">&nbsp;<\/span>Secretary of Commerce<span\nstyle='mso-tab-count:3'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>(US<br \/>\nArmy, Ret.)<\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'>Secretary<br \/>\nof Health and Human Services<span style='mso-tab-count:1'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>President<\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'>Commissioner<br \/>\nof EPA <span style='mso-tab-count:3'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'>Commissioner<br \/>\nof FDA<span style='mso-tab-count:3'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>____________________________________<\/p>\n<p><o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><span\nstyle='mso-tab-count:6'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>Rima<br \/>\nLaibow, MD <o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'>Prepared<br \/>\nby: <span style='mso-tab-count:4'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span><span\nstyle='mso-tab-count:1'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>Medical<br \/>\nDirector <o:p><\/o:p><\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'>Ralph<br \/>\nFucetola, JD <span style='mso-tab-count:4'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span><o:p><\/o:p><\/p>\n<p class=MsoNormal style='margin-left:2.5in;text-indent:.5in;mso-layout-grid-align:\nnone;text-autospace:none'>Natural Solutions Foundation <\/p>\n<p class=MsoNormal style='mso-layout-grid-align:none;text-autospace:none'>Procedural<br \/>\nAdvisor: Jim Turner, JD <span style='mso-tab-count:2'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>POB 722 <\/p>\n<p class=MsoNormal style='margin-left:2.5in;text-indent:.5in;mso-layout-grid-align:\nnone;text-autospace:none'>Maryville MO 64468<span style='mso-tab-count:\n3'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span><\/p>\n<p class=MsoNormal style='margin-left:2.5in;text-indent:.5in;mso-layout-grid-align:\nnone;text-autospace:none'>releyes@gmail.com<span style='font-size:\n11.0pt;font-family:\"PBACLN+TimesNewRoman\\,Bold\"'><o:p><\/o:p><\/span><\/p>\n<\/div>\n<p><span style='font-size:11.0pt;font-family:\"PBACLN+TimesNewRoman\\,Bold\";\nmso-ansi-language:EN-US;mso-fareast-language:EN-US'><br clear=ALL\nstyle='page-break-before:always;mso-break-type:section-break'><br \/>\n<\/span><\/p>\n<div class=Section2>\n<p class=MsoNormal><span style='font-size:11.0pt'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/span><\/p>\n<\/div>\n<div style='mso-element:footnote-list'><![if !supportFootnotes]><br clear=all><\/p>\n<hr align=left size=1 width=\"33%\">\n<p><![endif]><\/p>\n<div style='mso-element:footnote' id=ftn1>\n<p class=MsoFootnoteText><a style='mso-footnote-id:ftn1' href=\"#_ftnref1\"\nname=\"_ftn1\" title=\"\"><span class=MsoFootnoteReference><span style='mso-special-character:\nfootnote'><![if !supportFootnotes]>[1]<![endif]><\/span><\/span><\/a> <a\nhref=\"http:\/\/www.fao.org\/documents\/show_cdr.asp?url_file=\/docrep\/006\/j0776e\/j0776e01.htm\">http:\/\/www.fao.org\/documents\/show_cdr.asp?url_file=\/docrep\/006\/j0776e\/j0776e01.htm<\/a><br \/>\n<span style='mso-field-code:\"HYPERLINK \\0022http\\:\\\/\\\/www\\.fao\\.org\\\/docrep\\\/006\\\/j0776e\\\/j0776e00\\.HTM\\0022 \\\\t \\0022contentdoc\\0022\"'><span\nclass=MsoHyperlink>FAO Expert Consultation on Food Safety: Science and<br \/>\nEthics&#8230;<\/span><\/span> paragraphs 8 and 10<\/p>\n<\/div>\n<div style='mso-element:footnote' id=ftn2>\n<p class=MsoPlainText><a style='mso-footnote-id:ftn2' href=\"#_ftnref2\"\nname=\"_ftn2\" title=\"\"><span class=MsoFootnoteReference><span style='font-size:\n9.0pt;font-family:\"Times New Roman\"'><span style='mso-special-character:footnote'><![if !supportFootnotes]>[2]<![endif]><\/span><\/span><\/span><\/a><span\nstyle='font-size:9.0pt;font-family:\"Times New Roman\"'>Principles And Methods<br \/>\nFor The Assessment Of Risk From Essential Trace Elements<b> <a\nhref=\"http:\/\/www.healthfreedomusa.org\/wp-content\/plugins\/url-cloak-encrypt\/url.php?id=aHR0cDovL3d3dy5pbmNoZW0ub3JnLyUyMGRvY3VtZW50cy9laGMvZWhjL2VoYzIyOC5odG0jMS4w\" >http:\/\/www.inchem.org\/<br \/>\ndocuments\/ehc\/ehc\/ehc228.htm#1.0<\/a> and <\/b><\/span><span style='font-size:\n9.0pt;font-family:\"Times New Roman\"'>Problems Peculiar to the Setting of Limits<br \/>\nfor Essential Food Elements G.C. Becking Kingston, Ontario, Canada <a\nhref=\"http:\/\/www.nnia.co.za\/CPD\/articles\/risk_assessment.pdf\">http:\/\/www.nnia.co.za\/CPD\/articles\/risk_assessment.pdf<\/a><br \/>\nIn Risk Assessment in the Food Chain of Children, Edited by Peter J. Aggett and<br \/>\nHarry A Kuiper. Nestl\u00ef\u00bf\u00bd Nutrition Workshop Series, Pediatric Program, Vol. 44,<br \/>\nNestec Ltd., Vevey\/Lippincott Williams &amp; Wilkins, Philadelphia \u00ef\u00bf\u00bd 2000 each<br \/>\ndiscuss AROI.<span style=\"mso-spacerun: yes\">&nbsp; <\/span>Becking says \u00ef\u00bf\u00bdThe<br \/>\nproposed methodology is discussed with regard to its applicability to essential<br \/>\ntrace elements. However, it should be applicable to all essential food<br \/>\ncomponents subject to homeostatic control by the human body.\u00ef\u00bf\u00bd <o:p><\/o:p><\/span><\/p>\n<p class=MsoPlainText><span style='font-size:9.0pt;font-family:\"Times New Roman\"'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/span><\/p>\n<p class=MsoPlainText><span style='font-family:\"Times New Roman\"'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/span><\/p>\n<p class=MsoPlainText><span style=\"mso-spacerun: yes\">&nbsp;<\/span><\/p>\n<p class=MsoPlainText><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoPlainText><span style=\"mso-spacerun: yes\">&nbsp;<\/span><\/p>\n<h1><span style='font-size:10.0pt;font-weight:normal'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/span><\/h1>\n<\/div>\n<div style='mso-element:footnote' id=ftn3>\n<p class=MsoFootnoteText><a style='mso-footnote-id:ftn3' href=\"#_ftnref3\"\nname=\"_ftn3\" title=\"\"><span class=MsoFootnoteReference><span style='mso-special-character:\nfootnote'><![if !supportFootnotes]>[3]<![endif]><\/span><\/span><\/a> The text of<br \/>\nthe caveat, line 3 to the end, is from the Codex Guidelines on Nutrition<br \/>\nLabeling <a\nhref=\"http:\/\/www.fao.org\/documents\/show_cdr.asp?url_file=\/DOCREP\/005\/Y2770E\/y2770e06.htm\">http:\/\/www.fao.org\/documents\/show_cdr.asp?url_file=\/DOCREP\/005\/Y2770E\/y2770e06.htm<\/a><\/p>\n<p class=MsoFootnoteText><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<\/div>\n<div style='mso-element:footnote' id=ftn4>\n<p class=MsoFootnoteText><a style='mso-footnote-id:ftn4' href=\"#_ftnref4\"\nname=\"_ftn4\" title=\"\"><span class=MsoFootnoteReference><span style='mso-special-character:\nfootnote'><![if !supportFootnotes]>[4]<![endif]><\/span><\/span><\/a> <a\nhref=\"http:\/\/www.fao.org\/documents\/show_cdr.asp?url_file=\/docrep\/006\/j0776e\/j0776e01.htm\">http:\/\/www.fao.org\/documents\/show_cdr.asp?url_file=\/docrep\/006\/j0776e\/j0776e01.htm<\/a><br \/>\n<span style='mso-field-code:\"HYPERLINK \\0022http\\:\\\/\\\/www\\.fao\\.org\\\/docrep\\\/006\\\/j0776e\\\/j0776e00\\.HTM\\0022 \\\\t \\0022contentdoc\\0022\"'><span\nclass=MsoHyperlink>FAO Expert Consultation on Food Safety: Science and<br \/>\nEthics&#8230;<\/span><\/span> paragraphs 8 and 10<\/p>\n<\/div>\n<div style='mso-element:footnote' id=ftn5>\n<p class=MsoPlainText><a style='mso-footnote-id:ftn5' href=\"#_ftnref5\"\nname=\"_ftn5\" title=\"\"><span class=MsoFootnoteReference><span style='font-size:\n9.0pt;font-family:\"Times New Roman\"'><span style='mso-special-character:footnote'><![if !supportFootnotes]>[5]<![endif]><\/span><\/span><\/span><\/a><span\nstyle='font-size:9.0pt;font-family:\"Times New Roman\"'>Principles And Methods<br \/>\nFor The Assessment Of Risk From Essential Trace Elements<b> <a\nhref=\"http:\/\/www.healthfreedomusa.org\/wp-content\/plugins\/url-cloak-encrypt\/url.php?id=aHR0cDovL3d3dy5pbmNoZW0ub3JnLyUyMGRvY3VtZW50cy9laGMvZWhjL2VoYzIyOC5odG0jMS4w\" >http:\/\/www.inchem.org\/<br \/>\ndocuments\/ehc\/ehc\/ehc228.htm#1.0<\/a> and <\/b><\/span><span style='font-size:\n9.0pt;font-family:\"Times New Roman\"'>Problems Peculiar to the Setting of Limits<br \/>\nfor Essential Food Elements G.C. Becking Kingston, Ontario, Canada <a\nhref=\"http:\/\/www.nnia.co.za\/CPD\/articles\/risk_assessment.pdf\">http:\/\/www.nnia.co.za\/CPD\/articles\/risk_assessment.pdf<\/a><br \/>\nIn Risk Assessment in the Food Chain of Children, Edited by Peter J. Aggett and<br \/>\nHarry A Kuiper. Nestl\u00ef\u00bf\u00bd Nutrition Workshop Series, Pediatric Program, Vol. 44,<br \/>\nNestec Ltd., Vevey\/Lippincott Williams &amp; Wilkins, Philadelphia \u00ef\u00bf\u00bd 2000 each<br \/>\ndiscuss AROI.<span style=\"mso-spacerun: yes\">&nbsp; <\/span>Becking says \u00ef\u00bf\u00bdThe<br \/>\nproposed methodology is discussed with regard to its applicability to essential<br \/>\ntrace elements. However, it should be applicable to all essential food<br \/>\ncomponents subject to homeostatic control by the human body.\u00ef\u00bf\u00bd <o:p><\/o:p><\/span><\/p>\n<p class=MsoPlainText><span style='font-size:9.0pt;font-family:\"Times New Roman\"'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/span><\/p>\n<p class=MsoPlainText><span style='font-family:\"Times New Roman\"'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/span><\/p>\n<p class=MsoPlainText><span style=\"mso-spacerun: yes\">&nbsp;<\/span><\/p>\n<p class=MsoPlainText><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<p class=MsoPlainText><span style=\"mso-spacerun: yes\">&nbsp;<\/span><\/p>\n<h1><span style='font-size:10.0pt;font-weight:normal'><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/span><\/h1>\n<\/div>\n<div style='mso-element:footnote' id=ftn6>\n<p class=MsoFootnoteText><a style='mso-footnote-id:ftn6' href=\"#_ftnref6\"\nname=\"_ftn6\" title=\"\"><span class=MsoFootnoteReference><span style='mso-special-character:\nfootnote'><![if !supportFootnotes]>[6]<![endif]><\/span><\/span><\/a> The text of<br \/>\nthe caveat, line 3 to the end, is from the Codex Guidelines on Nutrition<br \/>\nLabeling <a\nhref=\"http:\/\/www.fao.org\/documents\/show_cdr.asp?url_file=\/DOCREP\/005\/Y2770E\/y2770e06.htm\">http:\/\/www.fao.org\/documents\/show_cdr.asp?url_file=\/DOCREP\/005\/Y2770E\/y2770e06.htm<\/a><\/p>\n<p class=MsoFootnoteText><![if !supportEmptyParas]>&nbsp;<![endif]><o:p><\/o:p><\/p>\n<\/div>\n<\/div>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p><a href=\"..\/step3.shtml\">Click here to return to the main site where you can add your name to the petition. <\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>NOTE: You can read these documents in your browser or use your browser&#8217;s Print function to print them out. &nbsp; When you&#8217;re done reading, click here to return to the page where you can add your name to the petition. &nbsp; &nbsp; To:&nbsp; Dr. Barbara Schneeman Director, Office of Nutritional Products Labeling and Dietary Supplements [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":184,"menu_order":0,"comment_status":"open","ping_status":"open","template":"getinvolved.php","meta":[],"_links":{"self":[{"href":"https:\/\/www.healthfreedomusa.org\/index.php?rest_route=\/wp\/v2\/pages\/185"}],"collection":[{"href":"https:\/\/www.healthfreedomusa.org\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.healthfreedomusa.org\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.healthfreedomusa.org\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.healthfreedomusa.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=185"}],"version-history":[{"count":1,"href":"https:\/\/www.healthfreedomusa.org\/index.php?rest_route=\/wp\/v2\/pages\/185\/revisions"}],"predecessor-version":[{"id":1675,"href":"https:\/\/www.healthfreedomusa.org\/index.php?rest_route=\/wp\/v2\/pages\/185\/revisions\/1675"}],"up":[{"embeddable":true,"href":"https:\/\/www.healthfreedomusa.org\/index.php?rest_route=\/wp\/v2\/pages\/184"}],"wp:attachment":[{"href":"https:\/\/www.healthfreedomusa.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=185"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}