Misc RM 40    Misc reference material   man or other animals  laws Part 2

 

Reference Material - For Information Only!

 

Over time we have collected a lot of reference material.

We figured it would be better to share with all rather than just delete it.

If you want it, keep it, otherwise just delete it.  

Due to the volume it will take more than one mailing.

 

 

Alfred Adask is involved in a court action.

Following is a letter sent to Dr. Paul by hand-delivering a copy of the document to Ron Paul's son in Iowa December 27, 2007.

 

Part 2 below:

 

EXCERPTS FROM AN AFFIDAVIT FILED BY Alfred Adask ON OCTOBER 22, A.D. 2006 INTO THE CASE FILE FOR GV-400268:

 

1.  Plaintiffs [The Texas Attorney General's] Motion for Summary Judgment dated on or about May 31st, A.D. 2006 declared in part:

"4.2. Definition of a "drug" pursuant to state and federal health codes.

 

"The key to this case lies in determining, at law and not as a matter of fact, whether the Defendants' colloidal products met the definition of a "drug" when mislabeled, falsely advertised, and sold as products intended to treat disease. TEX. HEALTH & SAFETY CODE §431.002(14) provides in pertinent part: [Bold emphasis added by Alfred Adask.]

 

"Drug" means articles recognized in the official United States Pharmacopoeia National Formulary, or any supplement to it, articles designed or intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals , [emphasis added] articles, other than food, intended to affect the structure or any function of the body of man or other animals , [emphasis added] and articles intended for use as a component of any article specified in this subdivision. The term does not include devices or their components, parts, or accessories. A food for which a claim is made in accordance with Section 403(r) of the federal Act, and for which the claim is approved by the secretary, [emphasis added] is not a drug solely because the label or labeling contains such a claim.  [Bold emphasis added by Alfred Adask.]

 

"The federal code, upon which the state code is based and which is virtually identical, is 21 U.S.C.A. §321(g)(1), which provides in pertinent part:

"The term "drug" means (A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals [emphasis added]; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals [emphasis added]; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C). A food or dietary supplement for which a claim, subject to sections 343(r)(1)(B) and 343(r)(3) of this title or sections 343(r)(1)(B) and 343(r)(5)(D) of this title, is made in accordance with the requirements of section 343(r) of this title [emphasis added] is not a drug solely because the label or the labeling contains such a claim. A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with section 343(r)(6) of this title is not a drug under clause (C) solely because the label or the labeling contains such a statement. [Bold emphasis added by Alfred Adask.]

 

"Defendants' colloidal products were therefore `drugs' within the meaning of TEx. HEALTH & SAFETY CODE §431.002(14) and 21 U.S.C. §321(g)(1) because they were labeled and advertised with testimonials and sold with the intent for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals" or in some instances, because they are sold with the intent of affecting "the structure or any function of the body of man or other animals". These products, when sold with the testimonial claims regarding treatment of disease, cannot be dietary supplements because none of the Defendants have ever applied to the USFDA nor received approval for the claims on these products published by Defendants on their Internet web sites."

 

2.  Note well that the phrase "man or other animals" appears twice in the cited state law, twice in the cited federal law, and twice more in the plaintiffs' conclusion and summary--for a total of six instances in plaintiffs' text.

 

3.  Plaintiffs argue, in essence, that the "key" to determining the allegations in GV400268 is determining "at law" whether alleged defendants advertised and sold alleged "drugs" with the " intent for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals " or "sold with the intent of affecting 'the structure or any function of the body of man or other animals '."

 

4. The phrase "man or other animals" can only be read to mean that, under the alleged laws and arguments advanced by plaintiffs, "man" is viewed by plaintiffs and/or our current government as nothing more than an "animal".

 

5.  I am a man endowed by my Creator with certain unalienable Rights.

 

6.  I deny that I am an animal.

 

7.  I deny that I do business with animals.

 

8.  I eat animals.

 

9.  I am a Protestant Christian.

 

10.  I fear the LORD; I am sincere in my faith.

 

11. "In the beginning God created the heavens and the earth."  Genesis 1:1, The Bible.

 

12.  "Then God said, "Let Us make man in Our image, according to Our likeness; let them have dominion over the fish of the sea, over the birds of the air, and over the cattle, over all the earth and over every creeping thing that creeps on the earth."  27 So God created man in His own image; in the image of God He created him; male and female He created them.  28 Then God blessed them, and God said to them, "be fruitful and multiply; fill the earth and subdue it; have dominion over the fish of the sea, over the birds of the air, and over every living thing that moves upon the earth."  Genesis 1: 26-28, The Bible.

 

13.  Plaintiffs' argument that "men" are "animals" defies the fundamental precept of the Jewish and Christian faiths that of all earthly creations, man--and man alone--is made in God's image and separate from animals in that man is endowed by God with dominion over animals.

 

14.  Plaintiffs' attempt to compel me, other alleged defendants, and all other men and women to accept the status of animals violates my sincerely held religious beliefs.

 

15.  "'Teacher, which is the greatest commandment in the law?' Jesus said to him,' you shall love the LORD your God with all your heart, with all your soul, and with all your mind.' This is the first and greatest commandment.  And the second is like it: 'You shall love your neighbor as yourself.' On these two commandments hang all the law and the prophets.'"  Matthew 22:36-40

 

16.  Plaintiff's "key" contention that "men" are "animals" prevents me--a man--from loving my fellow man.

 

17. The "Declaration of Independence" declares in part: "We hold these truths to be self-evident, that all men are created equal, that they are endowed by their Creator with certain unalienable Rights, that among these are Life, Liberty and the pursuit of Happiness." [Emphasis added.]

 

18. I deny that "animals" are endowed by their Creator with any "unalienable Rights."

 

19. The third sentence of the "Declaration of Independence" declares the principle duty of government: "That to secure these rights, Governments are instituted among Men, deriving their just powers from the consent of the governed."

 

20.  I am a man; the principal business of Government and its officers is to secure my God-given, unalienable Rights.

 

21.  Plaintiffs' attempt to equate all "men" with "animals" deprives me of the benefit of religious freedom and of the benefit of God-given, unalienable rights.

 

22.  Plaintiffs' attempt to equate all "men" with "animals" is an attempt to establish a pagan religion that is contrary to the principles of the Jewish and Christian faiths and impose this pagan religion upon the people of The United States of America.

 

23.  A plea to the jurisdiction is proper when the dispute clearly involves ecclesiastical matters over which the courts have no jurisdiction. See Hawkins v. Friendship Missionary Baptist Ch., 69 S.W.3d 756,758-59 (Tex.App.-Houston [14th Dist.] 2002, no pet.); Green v. United Pentecostal Ch. Int'l, 899 S.W.2d 28, 30 (Tex.App.-Austin 1995, writ denied); Patterson v. Southwestern Baptist Theological Seminary, 858 S.W.2d 602,604-05 (Tex.App.-Fort Worth 1993, no writ); see also Williams v. Gleason, 26 S.W.3d 54, 55-56 (Tex.App.­Houston [14th Dist.] 2000, pet. denied) (resolved issue by motion for summary judgment). Secular courts cannot constitutionally determine the truth or falsity of religious matters. Tilton v. Marshall, 925 S.W.2d 672, 678-79 (Tex.1996); see also Serbian E. Orthodox Diocese v. Milivojevich, 426 U.S. 696, 723 (1976) (religious controver­sies are not proper subject of civil court inquiry).

 

24.  "As a threshold requirement, [defendant] must demonstrate that her refusal to be photographed is grounded upon a sincerely held religious belief. See Stevens v. Berger, 428 F.Supp. 896, 899 (E.D.N.Y.1977). Although a religious belief requires something more than a purely secular philosophical or personal belief, Wisconsin v. Yoder, supra, 406 U.S. at 215-16, 92 S.Ct. at 1533-34, courts have approved an expansive definition of religion. See United States v. Seeger, 380 U.S. 163, 165-66, 85 S.Ct. 850, 853-54, 13 L.Ed.2d 733 (1965) (test is whether "a given belief that is sincere and meaningful occupies a place in the life of its possessor parallel to that filled by the orthodox belief in God"); see also International Society for Krishna Consciousness, Inc. v. Barber, 650 F.2d 430, 440 (2d Cir.1981); Founding Church of Scientology v. United States, 409 F.2d 1146 (D.C.Cir.), cert. denied, 396 U.S. 963, 90 S.Ct. 434, 24 L.Ed.2d 427 (1969)."  Quaring v Peterson, 728 F.2d 1121 (A.D. 1983)

 

25.  "[T]he guarantee of free exercise is not limited to beliefs which are shared by all of the members of a religious sect. Particularly in this sensitive area, it is not within the judicial function and judicial competence to inquire whether the petitioner or his fellow [adherent] more correctly perceived the commands of their common faith. Courts are not arbiters of scriptural interpretation." Thomas v. Review Board, supra, 450 U.S. at 715-16, 101 S.Ct. at 1430-31.

 

26.  "Under the proper analysis, a burden upon religion exists when 'the state conditions receipt of an important benefit upon conduct proscribed by a religious faith, * * * thereby putting substantial pressure on an adherent to modify his behavior and to violate his beliefs." Thomas v. Review Board, supra, 450 U.S. at 717-18, 101 S.Ct. at 1431-32.

 

27.  By treating all "men" to be "animals," the state withholds from me the important benefits and/or unalienable Rights of free association and pursuit of Happiness.

 

28.   "In Sherbert v. Verner, supra, . . . the Supreme Court held that in denying unemployment benefits to a member of the Seventh-Day Adventist Church who refused to work on Saturdays, the Sabbath of her faith, the state violated her right to the free exercise of religion. 374 U.S. at 402, 83 S.Ct. at 1792. Assessing the burden of the denial of benefits on the Sabbatarian's exercise of her religion, the Court commented,

"The [denial] forces her to choose between following the precepts of her religion and forfeiting benefits, on the one hand, and abandoning one of the precepts of her religion [not working on Saturdays] in order to accept work, on the other hand. Id. at 404, 83 S.Ct. at 1794."  Quaring v Peterson, supra.

 

29.  Under the pretext of treating all "men" as "animals," plaintiffs attempt to force me and other alleged defendants to choose between following the precepts of our religion and forfeiting benefits, on the one hand, and abandoning one of the precepts of our religion [recognizing our fellow men has made in the image of God rather than as animals] in order to work without the threat of undue regulation and excessive fines arbitrarily impose by "this state".

 

30.  For additional facts supporting this "Verified Notice of Special Appearance and Answer to Plaintiff's 5th Amended Petition," see attached "Notice By Affidavit of Alfred Adask" filed with the Travis County District Clerk on September 7th, A.D. 2006.

Further affiant says naught.

 

 

 

 

RELEVANT STATE & FEDERAL LAW

 

CHAPTER 431. TEXAS FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER A. GENERAL PROVISIONS

§ 431.001. SHORT TITLE.  This chapter may be cited as the Texas Food, Drug, and Cosmetic Act.

Acts 1989, 71st Leg., ch. 678, § 1, eff. Sept. 1, 1989 .

 

§ 431.002. DEFINITIONS.  In this chapter:

(1)  "Advertising" means all representations disseminated in any manner or by any means, other than by labeling, for the purpose of inducing, or that are likely to induce, directly or indirectly, the purchase of food, drugs, devices, or cosmetics.

(2)  "Animal feed," as used in Subdivision (23), in Section 512 of the federal Act, and in provisions of this chapter referring to those paragraphs or sections, means an article intended for use as food for animals other than man as a substantial source of nutrients in the diet of the animals.  The term is not limited to a mixture intended to be the sole ration of the animals.

 

. . . .

 

(6)(A) "Color additive" means a material that:

(i)  is a dye, pigment, or other substance made by a process of synthesis or similar artifice, or extracted, isolated, or otherwise derived, with or without intermediate or final change of identity from a vegetable, animal, mineral, or other source;  and

(ii)  when added or applied to a food, drug, or cosmetic, or to the human body or any part of the human body, is capable, alone or through reaction with other substance, of imparting color.  The term does not include any material exempted under the federal Act.

. . . .

(10)  "Cosmetic" means articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part of the human body for cleaning, beautifying, promoting attractiveness, or altering the appearance, and articles intended for use as a component of those articles.  The term does not include soap.

 

(11)  "Counterfeit drug" means a drug, or the container or labeling of a drug, that, without authorization, bears the trademark, trade name or other identifying mark, imprint, or device of a drug manufacturer, processor, packer, or distributor other than the person who in fact manufactured, processed, packed, or distributed the drug, and that falsely purports or is represented to be the product of, or to have been packed or distributed by, the other drug manufacturer, processor, packer, or distributor.

 

(12)  "Department" means the Texas Department of Health.

 

(13)  "Device," except when used in Sections 431.003,  431.021(l), 431.082(g), 431.112(c) and 431.142(c), means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, that is:

(A)  recognized in the official United States Pharmacopoeia National Formulary or any supplement to it;

(B)  intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in man or other animals;  or

(C)  intended to affect the structure or any function of the body of man or other animals and that does not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals and is not dependent on metabolization for the achievement of any of its principal intended purposes.

 

(14)  "Drug" means articles recognized in the official United States Pharmacopoeia National Formulary, or any supplement to it, articles designed or intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals, articles, other than food, intended to affect the structure or any function of the body of man or other animals , and articles intended for use as a component of any article specified in this subdivision.  The term does not include devices or their components, parts, or accessories.  A food for which a claim is made in accordance with Section 403(r) of the federal Act, and for which the claim is approved by the secretary, is not a drug solely because the label or labeling contains such a claim.

 

(15)  "Federal Act" means the Federal Food, Drug and Cosmetic Act (Title 21 U.S.C. 301 et seq.).

 

(16)  "Food" means:

(A)  articles used for food or drink for man;

(B)  chewing gum;  and

(C)  articles used for components of any such article.

. . . .

 

(20)  "Infant formula" means a food that is represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk.

 

. . . .

 

United States Code

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER II - DEFINITIONS


U.S. Code as of: 01/19/04

Section 321. Definitions; generally

 

      For the purposes of this chapter -

      (a)(1) The term "State", except as used in the last sentence of section 372(a) of this title, means any State or Territory of the United States, the District of Columbia , and the Commonwealth of Puerto Rico.

      (2) The term "Territory" means any Territory or possession of the United States, including the District of Columbia, and excluding the Commonwealth of Puerto Rico and the Canal Zone.

      (b) The term "interstate commerce" means (1) commerce between any State or Territory and any place outside thereof, and (2) commerce within the District of Columbia or within any other Territory not organized with a legislative body.

      (c) The term "Department" means Department of Health and Human Services.

      (d) The term "Secretary" means the Secretary of Health and Human    Services.

      (e) The term "person" includes individual, partnership, corporation, and association.

      (f) The term "food" means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.

      (g)(1) The term "drug" means (A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food)intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C). A food or dietary supplement for which a claim, subject to sections 343(r)(1)(B) and 343(r)(3) of this title or sections 343(r)(1)(B)and 343(r)(5)(D) of this title, is made in accordance with the requirements of section 343(r) of this title is not a drug solely because the label or the labeling contains such a claim. A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with section 343(r)(6) of this title is not a drug under clause (C) solely because the label or the labeling contains such a statement.

      (2) The term "counterfeit drug" means a drug which, or the container or labeling of which, without authorization, bears the    trademark, trade name, or other identifying mark, imprint, or device, or any likeness thereof, of a drug manufacturer, processor, packer, or distributor other than the person or persons who in fact manufactured, processed, packed, or distributed such drug and which thereby falsely purports or is represented to be the product of, or to have been packed or distributed by, such other drug manufacturer, processor, packer, or distributor.

      (h) The term "device" (except when used in paragraph (n) of this section and in sections 331(i), 343(f), 352(c), and 362(c) of this title) means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is -

        (1) recognized in the official National Formulary, or the      United States Pharmacopeia, or any supplement to them,

        (2) intended for use in the diagnosis of disease or other      conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

        (3) intended to affect the structure or any function of the    body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

      (i) The term "cosmetic" means (1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.

      . . . .

 

      (3) Notwithstanding subparagraphs (1) and (2), the Administrator may by regulation except a substance from the definition of "pesticide chemical" or "pesticide chemical residue" if -

        (A) its occurrence as a residue on or in a raw agricultural commodity or processed food is attributable primarily to natural causes or to human activities not involving the use of any substances for a pesticidal purpose in the production, storage, processing, or transportation of any raw agricultural commodity or processed food; and

        (B) the Administrator, after consultation with the Secretary, determines that the substance more appropriately should be regulated under one or more provisions of this chapter other than sections 342(a)(2)(B) and 346a of this title.

 

  . . . .

 

      (t)(1) The term "color additive" means a material which -

        . . . .

     

      (v) The term "new animal drug" means any drug intended for use

    for animals other than man, including any drug intended for use in animal feed but not including such animal feed, -

        . . . .

 

      (w) The term "animal feed", as used in paragraph (w) (!1) of this section, in section 360b of this title, and in provisions of this chapter referring to such paragraph or section, means an article which is intended for use for food for animals other than man and which is intended for use as a substantial source of nutrients in the diet of the animal, and is not limited to a mixture intended to be the sole ration of the animal.

 

. . . .

 

      (z) The term "infant formula" means a food which purports to be or is represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk.

     

. . . .

 

      (ff) The term "dietary supplement" -

        (1) means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients:

          (A) a vitamin;

          (B) a mineral;

          (C) an herb or other botanical;

          (D) an amino acid;

          (E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or

          (F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E);

 

       

 

. . . .

 

      (jj) The term "antibiotic drug" means any drug (except drugs for use in animals other than humans ) composed wholly or partly of any kind of penicillin, streptomycin, chlortetracycline, chloramphenicol, bacitracin, or any other drug intended for human use containing any quantity of any chemical substance which is produced by a micro-organism and which has the capacity to inhibit or destroy micro-organisms in dilute solution (including a chemically synthesized equivalent of any such substance) or any derivative thereof.

      . . . .

 

 

 

Ballentine's Law Dictionary (Professor of Law, University of California,) 1948 Edition, offers the following definitions:

 

Human being.  See Monster . (Page 599)

 

MonsterA human-being by birth, but in some part resembling a lower animal. A A monster . . . hath no inheritable blood, and cannot be heir to any land, albeit it be brought forth in marriage; but, although it hath deformity in any part of its body, yet, if it hath human shape, it may be heir. @ 2 Bl. Comm. 246. (Page 830).

 

 

Blackstone's Commentaries, Book II, page 246, 247, Ch. 15, section 334

Monsters.  A monster, which hath not the shape of mankind, but in any part evidently bears the resemblance of the brute creation, hath no inheritable blood, and cannot be heir to any land, albeit it be brought forth in marriage: but, although it hath deformity in any part of its body, yet if it hat human shape, it may heir.  This is a very ancient rule in the law of
England;(f/n g)  and its reason is too obvious, and too shocking, to bear minute discussion.

footnote g -- Those who are born with an form no human are not considered children; as when a woman by a perversion of nature brings forth something monstrous or prodigious. 

 

  

  

* United States Code o TITLE 21 - FOOD AND DRUGS + CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT # SUBCHAPTER V - DRUGS AND DEVICES

* PART A - DRUGS AND DEVICES

 

U.S. Code as of: 01/19/04

 Section 360 . Registration of producers of drugs or devices

 (a) Definitions As used in this section -

. . . .

(e) Registration number; uniform system for identification of devices intended for human use The Secretary may assign a registration number to any person or any establishment registered in accordance with this section. The Secretary may also assign a listing number to each drug or class of drugs listed under subsection (j) of this section. Any number assigned pursuant to the preceding sentence shall be the same as that assigned pursuant to the National Drug Code. The Secretary may by regulation prescribe a uniform system for the identification of devices intended for human use and may require that persons who are required to list such devices pursuant to subsection (j) of this section shall list such devices in accordance with such system.

 

. . . .

 

 (j) Filing of lists of drugs and devices manufactured, prepared, propagated and compounded by registrants; statements; accompanying disclosures

(1) Every person who registers with the Secretary under subsection (b), (c), (d), or (i) of this section shall, at the time of registration under any such subsection, file with the Secretary a list of all drugs and a list of all devices and a brief statement of the basis for believing that each device included in the list is a device rather than a drug (with each drug and device in each list listed by its established name (as defined in section 352(e) of this title) and by any proprietary name) which are being manufactured, prepared, propagated, compounded, or processed by him for commercial distribution and which he has not included in any list of drugs or devices filed by him with the Secretary under this paragraph or paragraph (2) before such time of registration. Such list shall be prepared in such form and manner as the Secretary may prescribe and shall be accompanied by -

(A) in the case of a drug contained in the applicable list and subject to section 355 or 360b of this title, or a device intended for human use contained in the applicable list with respect to which a performance standard has been established under section 360d of this title or which is subject to section 360e of this title, a reference to the authority for the marketing of such drug or device and a copy of all labeling for such drug or device;

 

. . . .

 

 

(k) Report preceding introduction of devices into interstate commerce Each person who is required to register under this section and who proposes to begin the introduction or delivery for introduction into interstate commerce for commercial distribution of a device intended for human use shall, at least ninety days before making such introduction or delivery, report to the Secretary or person who is accredited under section 360m(a) of this title (in such form and manner as the Secretary shall by regulation prescribe) -

(1) the class in which the device is classified under section 360c of this title or if such person determines that the device is not classified under such section, a statement of that determination and the basis for such person's determination that the device is or is not so classified, and

(2) action taken by such person to comply with requirements under section 360d or 360e of this title which are applicable to the device.

(l) Exemption from reporting requirements A report under subsection (k) of this section is not required for a device intended for human use that is exempted from the requirements of this subsection under subsection (m) of this section or is within a type that has been classified into class I under section 360c of this title. The exception established in the preceding sentence does not apply to any class I device that is intended for a use which is of substantial importance in preventing impairment of human health, or to any class I device that presents a potential unreasonable risk of illness or injury.

 

 

 

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