Gail Gantt
Executive Secretary
Center for Devices and Radiological Health (HFZ-410)
Food and Drug Administration
9200 Corporate Blvd.
Rockville, MD 20850
GGG@cdrh.fda.gov

Re: Federal Register Docket 98-887

I. INTRODUCTION

A. Introduction of Attorneys for the Rights of the Child

Attorneys for the Rights of the Child (ARC) is an international network of attorneys working to raise judicial, legal, and public awareness regarding the male child’s inherent legal and human rights to physical integrity and self-determination. ARC believes that male circumcision is a serious violation of domestic and international law as well as an affront to the dignity and bodily
integrity of all affected victims.

ARC representatives have published pertinent articles in legal and medical journals on children’s rights to bodily integrity and to freedom from medically unnecessary genital surgery. ARC representatives have also presented papers at various respected conferences, including the Fourth International Symposium on Sexual Mutilations in Lausanne, Switzerland and, more recently, at the Seventh Interdisciplinary Conference on Male Sexual Victimization in Orinda, California.

B. Approval of Applications Would Subject FDA and US to Penalties Under International Human Rights Law

We urge you in the strongest possible terms to deny the applications for the premarket approval applications (PMA’s) for Advanced Tissue Sciences’ Dermagraft wound dressings made from baby boys’ foreskins. Approval of these applications would subject the Food and Drug Administration and the United States government to international penalties for promoting a continuing violation of domestic and human rights law. The FDA should dismiss both applications and instead devote its resources on this issue in conformance with national and international law by encouraging the development of medical products made from more suitable materials that are not derived from tissue taken from the foreskins of infant patients.

As discussed below, reasons for profound concern with infant male circumcision exist. As discussed below in more detail, reasons for concern with the procedure under human rights principles include a profound loss of highly specialized and sensitive sexual tissue which also serves important protective functions, loss of bodily integrity, traumatic and highly painful disfigurement, complications with a range of severity up to and including death and loss of the entire penis, and the impermissibility of any mutilation of children’s genitals performed with neither their consent nor medical justification.

Human rights agreements–applicable either through ratification or through customary law–forbid circumcision based on such important principles as the rights of the child, the right to freedom of religion, the right to the highest attainable standard of health, and the right to protection against torture. The many laws against female genital mutilation, and the discriminatory failure to outlaw and vilify male genital mutilation, violate equal protection under both international human rights law and American legal doctrines.

Under well-recognized principles of international law, human rights agreements and other international laws may be widely enough observed by the community of nations to acquire the status of customary law. Customary law is applicable to all states regardless of whether they have themselves actually ratified the document in question. Therefore, the United States’ failure to
ratify certain human rights agreements does not necessarily insulate us from liability for violations of internationally recognized human rights as set forth in those documents.

The United States now bears the dubious distinction of being the only country in the world with an operating government not to have ratified the Convention on the Rights of the Child (CRC). Somalia, which currently lacks a functioning governing body, is the only other country not to have ratified the CRC. Combined with our back dues owed to the United Nations which are currently approaching $2 billion, these facts have given us a reputation as a human rights outlaw in the international community. In addition to our status as the only nation capable of ratifying the CRC which has not yet done so, the United States is also the only country in the world which routinely circumcises the majority of its baby boys for non-religious reasons. One can hardly imagine a clearer example of a factual setting in which customary law would show a country to be a human rights violator than the present case. Your approval of these applications would significantly expand the United States’ participation in this ongoing violation by creating the market for human foreskins, thereby creating a new profit incentive for the procedure.

Male circumcision is one principal way in which our country violates international human rights norms on a daily, indeed, second-by-second basis. Approval of the proposed premarket approval applications (PMA’s) for wound dressings made from human foreskins would constitute a tacit endorsement of male circumcision. Moreover, the proposed marketing of previously healthy, functional human genital tissue would constitute promotion of and collaboration in a continuing severe human rights violation. The FDA’s approval of these PMA’s would constitute further government involvement in male circumcision and would seriously aggravate our ongoing violation of relevant national and international laws, as discussed below.

II. REASONS FOR STRONG CONCERN WITH INFANT MALE CIRCUMCISION

A number of reasons exist for strong concern with the various forms of harm caused by circumcision. Beginning at least as early as 1965, numerous researchers have documented the various forms of harm inflicted by circumcision. Circumcision was found to be perceived by the child as an act of aggression and castration, to weaken the ego, disturb sexual identification, initiate regression toward more infantile and primitive modes of expression, and cause the child to withdraw and isolate itself from the disturbing stimuli. (Cansever G. Psychological effects of circumcision. British Journal of Medical Psychology 1965 38:321-331.1) Research also suggests that circumcision causes behavioral changes and that some reported gender differences may actually be a result of circumcision. (Richards MPM, Bernal JF, and Brackbill Y. Early Behavioral Differences: Gender or Circumcision? Developmental Psychobiology 1976 9:89-95.)

The myth that a newborn baby cannot suffer pain has been convincingly debunked. (See, e.g., Anand KJS and Hickey PR. Pain and its Effects in the Human Neonate and Fetus. New England Journal of Medicine 1987; 317:1321-1329.) The harm circumcision causes to babies by the severe levels of pain has been repeatedly documented. (See, e.g., Gunnar M, Malone S, Vance G, and Fisch R. Coping with Aversive Stimulation in the Neonatal Period: Quiet Sleep and Plasma Cortisol Levels during Recovery from Circumcision. Child Development 1985; 56:824-834.) Concrete medical evidence demonstrates that relative to an adult, the circumcision experience is significantly more traumatizing to an infant, who has not yet developed methods to cope with pain and whose neurological pathways are not yet fully developed. (See, e.g., Anand KJS and Hickey PR. Pain and its Effects in the Human Neonate and Fetus. New England Journal of Medicine 1987; 317:1321-1329.) At least one study found that the level of adrenal cortisol response to the pain and stress of the procedure exceeds the response to blood sampling or injections and is not significantly reduced even by application of an anesthetic. (Williamson P and Evans N. Neonatal Cortisol Response to Circumcision with Anesthesia. Clinical Pediatrics 1986; 25:412-415.)

This pain in turn causes permanent and irreversible changes in the developing brain, altering portions of the brain responsible for perceiving pain. (Dixon S, Snyder J, Holve R and Bromberger P. Behavioral effects of circumcision with and without anesthesia. Journal of Developmental and Behavioral Pediatrics 1984; 5:246-250. Taddio A. Goldbach M. Ipp M. Stevens B. Koren G. Effect of neonatal circumcision on pain response during vaccination in boys. Lancet 1995; 345:291-292. Fleiss PM Circumcision Lancet 1995; 345:927.) Developmental neuro-psychologist James Prescott found that domestic levels of violent crime, particularly violent sex-related crimes such as rape, grew in direct proportion to the rise in the number of sexually active circumcised males in American society:
“It is not without psychobiological consequences that the brain system which is designed for the experience of pleasure and the expression of sexual love is first encoded with extraordinary and excruciating pain. In such individuals, all subsequent acts or experiences of genital pleasure are experienced upon a background of genital pain that is now deeply buried in the subconscious/unconscious brain . . . When these early experiences of genital pain are followed by a developmental deprivation of physical affectional pleasure in the maternal-infant relationship and in the adolescent sexual relationship, then violent destructive behaviors are the inevitable outcome. (Prescott JW. Genital Pain vs. Genital Pleasure: why the one and not the other. Truth Seeker 1989; 1:14-21.)”

In a widely noted article, three researchers recently found that an average circumcision removes 51% of a male’s genital skin sheath and also a highly significant number of nerve endings including extremely specialised tissue unique to that part of the body and fundamental to human sexual response. (Taylor JR, Lockwood AP and Taylor AJ. The Prepuce: Specialized Mucosa of the Penis and its Loss to Circumcision. British Journal of Urology 1996;77:291-295.) Complications, which include deaths and loss of the entire penis, occur with a frequency of between 2-5% or more depending on the definition applied. (Kaplan G. Complications of Circumcision. Urologic Clinics of North America 1983; 10:543-549. J. Gearhart and J. Rock. Total Ablation of the Penis after Circumcision with Electrocautery: A Method of Management and Long-Term Followup. Journal of Urology (Baltimore) 1989; 142:799-801.)

Psychologist and author Ronald Goldman has comprehensively summarized the broad range of traumas caused by the procedure, including infant pain response, serious harm to infant neurological development and memory capability, the damage caused by memories of the procedure, the damage caused to self-esteem and body image, post-traumatic stress disorder, and serious sex-related effects. (Goldman R. Circumcision: The Hidden Trauma. Boston: Vanguard Publications, 1997:1-56, 82-123.)

Reasons for concern with the procedure under human rights principles thus include a profound loss of highly specialized and sensitive sexual tissue which also serves important protective functions, loss of bodily integrity, traumatic and highly painful disfigurement, complications with a range of severity up to and including death or loss of the entire penis, and the impermissibility of any mutilation of children’s genitals performed with neither their consent nor medical justification.

Many unsuccessful attempts at justifications for the procedure have been made throughout the past century–hygiene, prevention of penile cancer, prevention of urinary tract infections, prevention of AIDS, etc. Yet no suggested medical basis for routine circumcision has ever survived scientific scrutiny. (Morgan WK. The Rape of the Phallus. Journal of the American Medical Association 1965; 193:123-4. EN Preston. Whither the Foreskin? – A Consideration of Routine Neonatal Circumcision. Journal of the American Medical Association 1970; 213:1853-8.) The British Medical Society, Canadian Pediatric Society, Australian College of Paediatrics, and even the American Academy of Pediatrics have stated that there is no justification for routine circumcision. (Fetus and Newborn Committee, Canadian Paediatric Society. Neonatal Circumcision Revisited. Canadian Medical Association Journal 1996; 154:769-780. Australian College of Paediatrics. Position Statement: Routine Circumcision of Normal Male Infants and Boys. 27 May 1996. American Academy of Pediatrics, Committee on Fetus and Newborn. Standards and Recommendations for Hospital Care of Newborn Infants, 5th ed. Evanston, IL: American Academy of Pediatrics, 1971:110. This position was reiterated in 1975. Thompson HC, King LR, Knox E., et al. Report of the ad hoc task force on circumcision. Pediatrics 1975; 56:610-611. The position was again reiterated in 1983. American Academy of Pediatrics. Committee on Fetus and Newborn. Guidelines for Perinatal Care, 1st ed. Evanston, IL: American Academy of Pediatrics, 1983:87. However, with leading circumcision proponent Edgar J. Schoen sitting on the AAP Task Force on Circumcision, in 1989 the AAP issued a more “balanced” report. American Academy of Pediatrics Task Force on Circumcision. Report of the Task Force on Circumcision. Pediatrics 1989; 84:388-391. The AAP is currently preparing to issue a new position statement on the issue.)

Science has thus now turned its attention to male circumcision and has corrected many prior misconceptions which are holdovers from the Nineteenth and early Twentieth centuries. The procedure causes serious harm and lacks medical justification; it should not be tolerated in any civilized society.

III. HUMAN RIGHTS PRINCIPLES FORBID INFANT CIRCUMCISION

Well recognized human rights principles forbid circumcision, and all other forms of male genital mutilation, as a human rights violation.

A. Circumcision Prohibited by Several Human Rights Documents Several United Nations resolutions, conventions and declarations appear to forbid routine infant male circumcision. These prohibitions are based on such critical rights as the rights of the child, the right to freedom of religion, the right to the highest attainable standard of health, and the right to protection against torture.

1. Rights of the Child.

The Convention on the Rights of the Child–which we have signed but not ratified–imposes various obligations which are violated by male genital mutilation, including sexual abuse, torture, interference with privacy, the right to safety while under the care of a parent or guardian, and the right to health.

a. Male genital mutilation prohibited under provisions regarding sexual abuse, torture, and interference with privacy.

Article 34 of the Convention on the Rights of the Child requires states which are parties to the CRC (“states parties”) to undertake to protect the child from all forms of sexual exploitation and sexual abuse, and Article 36 further obliges states parties to protect the child against all other forms of exploitation prejudicial to any aspects of the child’s welfare. (“Convention on the Rights of the Child,” UN GA resolution 44/25, November 20, 1989.) Article 37(a) of the Convention on the Rights of the Child forbids subjecting any child to torture or other cruel, inhuman or degrading treatment or punishment. Article 16 bars arbitrary or unlawful interference with a child’s privacy, and gives children the right to the law’s protection against such interference. The Declaration of the Rights of the Child also stipulates that children must be protected against all forms of cruelty, neglect, and exploitation. (“Declaration of the Rights of the Child,” UN GA resolution 1386 (XIV), November 20, 1959, Principle 9.) The current practices of governments such as the United States which permit, encourage, and even arrange for circumcision are in violation of all of these provisions. The government is acting illegally in facilitating circumcisions through for example, public health facilities, and in failing to prevent these violations whether carried out by public or private actors.

b. Child’s right to safety while under care of parent or guardian violated by circumcision.

Article 19.1 of the Convention on the Rights of the Child provides that states parties must take all measures to insure that no violence, injury, or abuse, etc. occurs while the child is under the care of a parent or legal guardian. This article is violated by the circumcision of an infant while under a responsible adult’s care, given the complications of the procedure and the lack of medical justification.

c. Parent or guardian is powerless to consent to an unnecessary medical procedure on a child.

The Committee on Bioethics of the American Academy of Pediatrics has stated in strong language the conceptual and ethical difficulties with the idea of “consent” by proxy:

“[P]roxy consent” poses serious problems for pediatric health care providers. Such providers have legal and ethical duties to their child patients to render competent medical care based on what the patient needs, not what someone else expresses… [T]he pediatrician’s responsibilities to his or her patient exist independent of parental desires or proxy consent. (American Academy of Pediatrics Committee on Bioethics. Informed Consent, Parental Permission, and Assent in Pediatric Practice. Pediatrics 1995; 95:315.)

Moreover, with certain limited exceptions not relevant here, patients even have the right to refuse medical intervention of demonstrable medical necessity. (See, e.g., American Academy of Pediatrics Committee on Bioethics. Informed Consent, Parental Permission, and Assent in Pediatric Practice. Pediatrics 1995; 95:314.) Circumcision is thus a violation of medical ethics because it is not based on a medical need of the patient and the patient has not agreed to the procedure. The Committee on Bioethics emphasized that the power to consent to a procedure rests solely with the patient himself or herself:
“Only patients who have appropriate decisional capacity and legal empowerment can give their informed consent to medical care. In all other situations, parents or other surrogates provide informed permission for diagnosis and treatment of children with the assent of the child whenever appropriate.” (Ibid.)

A parent’s or guardian’s assent cannot justify a non-medically necessary procedure such as circumcision. Only the consent of the individual himself can permit such an operation, and no infant is capable of providing such a consent. (See also generally Dwyer, J. Parents’ Religion and Children’s Welfare: Debunking the Doctrine of Parents’ Rights. California Law Review 1994; 82:1371-1447.)

d. Child’s right to health is violated by procedure.

Article 24 of the Convention on the Rights of the Child addresses health issues. Section 1 obliges states parties to recognize the child’s right to enjoy the highest attainable standard of health. Similarly, Section 2 of Article 24 requires states parties to pursue full implementation of the child’s right to enjoy the highest attainable health standard and to take appropriate measures, inter alia, to diminish infant and child mortality. These guarantees are violated where a medically unnecessary and extremely painful alteration of an infant male’s genitals is performed, subjecting the child to the risk of complications and possible death. Section 3 requires states parties to take all effective and appropriate measures with a view to abolishing traditional practices prejudicial to the health of children. Article 24.1 of the International Covenant on Civil and Political Rights–which we ratified in 1992–provides that every child shall have, without any discrimination as to, inter alia, sex, the right to such measures of protection as are required by his status as a minor, on the part of his family, society and the state. (“International Covenant on Civil and Political Rights,” UN GA resolution 2200 A [XXI], December 16, 1966.)

2. Freedom of Religion Does Not Justify Procedure

The right of freedom of religion does not justify and conflicts with male circumcision.

a. Children Bear Independent Right to Freedom of Religion

Children bear their own right to freedom of religion, independent of the wishes of their parents or guardians. Under Article 14.1 of the Convention on the Rights of the Child, children have the right to demand that states parties respect their right to freedom of thought, conscience, and religion. No infant is capable of consenting to a surgical procedure based on his own religion. Where the procedure is one based on religion, it is therefore the parent’s religion which motivates the procedure and not the religion of the person whose genitals are being surgically altered. A parent’s consent is therefore again clearly insufficient. (See generally Dwyer J. Debunking the Doctrine. Supra note 21. It should also be noted that medical circumcisions can never satisfy Jewish law, which requires the presence of a mohel to perform the procedure and a sandek to assist by holding the baby, and also stipulates, inter alia, certain specific rituals and the performance of the act on the eighth day following birth. See, e.g., Diamant A. The NEW Jewish Baby Book. Woodstock, Vermont: JEWISH LIGHTS Publishing, 1994:95, 89-109.)

Moreover, it is precisely in the interest of preserving freedom of religion that the government must prevent ritual infant or childhood mutilations of either gender. The act of marking a child with a ritual mutilation, particularly upon the genitals, takes away that individual’s right to a whole, functional body and his right to choose whether to be marked with the scars of that particular religion.

b. Exception to Freedom of Religion Applies Here

Moreover, even if religion did somehow justify the procedure, which it clearly does not do, identical language in Article 14.3 of the Convention on the Rights of the Child, Article 18.3 of the International Covenant on Civil and Political Rights and Article 12.3 of the American Convention on Human Rights–is very clear in providing that an exception to the requirement to permit freedom of conscience and religion arises where such freedom if exercised would result in violating the public safety, order, health, or morals, or the fundamental rights and freedoms of another human being. A traumatic disfigurement of a nonconsenting baby’s genitals can reasonably qualify as such a violation under this exception.

Therefore, again, human rights principles forbid the mutilation.

3. Treaties Prohibiting Torture Apply to Circumcision

Treaties prohibiting torture, including the Convention Against Torture, the Declaration Against Torture, and the American Convention on Human Rights–signed but not ratified by the United States–also prohibit routine infant male circumcision.

a. Definition of Torture.

The Convention Against Torture–ratified by the United States–defines torture as, inter alia, any act by which severe pain or suffering, physical or mental, is intentionally inflicted on a person, with the consent or acquiescence of or at the instigation of a public official. (“Convention Against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment,”UN GA resolution 39/46, December 10, 1984, Article 1.) The Declaration Against Torture holds torture to be an aggravated and deliberate form of cruel, inhuman or degrading treatment or punishment which violates the human rights and fundamental freedoms proclaimed in the Universal Declaration of Human Rights. (Articles 1.2 and 2, “Declaration on the Protection of All Persons from Being Subjected to Torture, and Other Cruel, Inhuman, or Degrading Treatment or Punishment,” UN GA resolution 3452 (XXX), December 9, 1975.) Article 7 of the International Covenant on Civil and Political Rights and Article 5.1 of the American Convention on Human Rights provide that no one shall be subjected to torture or to cruel, inhuman, or degrading punishment or treatment.

b. Circumcision Constitutes Torture.

Ecumenics International, which as discussed below is currently working closely with the United Nations to combat genital mutilation, notes that, whether performed on male or female persons, “Genital mutilation is a traditional practice of physiological torture and psychological trauma destroying reproductive integrity and sexual health with significant risks of death.” (Ecumenics International. News Release: Ad Hoc Working Group of International Experts on Violations of Genital Mutilation. Sloatsburg, New York: Ecumenics International July 1, 1995.) No objective observer who has witnessed a circumcision can seriously dispute that the procedure inflicts severe pain or suffering on the child. Circumcision does constitute torture.

c. United States Routinely Violates Torture Treaties.

The United States routinely violates the Convention Against Torture and the Declaration Against Torture. Article 2.1 of the Convention Against Torture obliges a state party to take effective legislative, administrative, judicial or other measures to prevent acts of torture in any territory under its jurisdiction, and Article 2.2 adds that no exceptional circumstances whatsoever may justify the torture. Articles 4.1 and 4.2 of the Convention Against Torture state that any act of torture is a criminal offense which states parties must punish. Obviously the United States is not in compliance with these provisions: Our nation’s laws permit the procedure, and many circumcisions are initiated, promoted, allowed, and/or paid for by public health officials and/or performed in public hospitals. Furthermore, state obligations regarding circumcision extend to all procedures, whether or not performed with direct government participation. Article 3 of the Declaration Against Torture prohibits any state from permitting or tolerating torture or other cruel, inhuman and degrading treatment or punishment. The United States, by failing to take action against circumcision as well as by subsidizing and performing the procedure, is also violating this article.

Without being explicitly defined, torture is also forbidden under Article 5 of the Universal Declaration of Human Rights, which we have adopted, Article 7 of the International Covenant on Civil and Political Rights, and Article 37(a) of the Convention on the Rights of the Child.

IV. AMERICAN AND STATE LAWS AGAINST ONLY FEMALE GENITAL MUTILATION FAIL TO OUTLAW MALE GENITAL MUTILATION IN VIOLATION OF EQUAL PROTECTION UNDER HUMAN RIGHTS LAW AND UNITED STATES CONSTITUTION

Laws against female genital mutilation which do not simultaneously prohibit male genital mutilation contravene principles of equal protection enshrined in human rights law. The many statutes passed by the United States or by an American state also violate the requirement of equal protection under the United States Constitution. (104th Congress, 1st Session, House of Representatives Bill 2202. 104th Congress, 2nd Session, House of Representatives Bill 3019(e)(1). California Penal Code 273.4. Delaware Code Title 11, 1113, 4205(b)(3) (date of enactment July 3, 1996). Minnesota Statutes 609.2245, 609.02. California Health and Safety Code 124170; Minnesota Criminal Code 144.3872. North Dakota Criminal Code 12.1-36-01, 12.1-32-01.4. 1996 Session, Rhode Island Senate Bill 2317, codified as Rhode Island General Law 11-5-2 (date of enactment July 3, 1996). Tennessee Code Annotated 39-13-857, 40-35-111(b)(4). 1995 Wisconsin Assembly Bill 365 (date of enactment May 28, 1996).)

V. DENIAL OF THE APPLICATION IS REQUIRED UNDER BASIC PRINCIPLES OF MORALITY

Moral systems are one principal foundation of our legal system. They also constitute an ineluctable element of human civilization and carry great value in their own right. The removal of healthy, functional genital tissue (see section II, supra) from baby boys in a very painful operation and the subsequent exploitation of it for profit constitutes a moral affront of great import. Such an action would invoke severe political, diplomatic, public relational, and moral–not to mention legal–consequences. The FDA’s disapproval of the PMA’s is the only possible course to avoid this legal and moral danger.

VI. CONCLUSION

Circumcision causes lasting and severe harm to the males who are compelled to have the procedure performed on their bodies. A number of human rights documents–whether ratified or applicable under principles of customary international law–forbid routine infant male circumcision. We benefit today from a more profound understanding than we have ever had before of the medical and psychological harm caused by circumcision as well as the legal and human rights barriers to the practice, and thus should criminalize it and thereby protect our children. Disapproval of the PMA’s constitutes a necessary step for the FDA and the nation in ensuring that we do not run afoul of international law and do not violate the legal and moral rights of our male children in the pursuit of corporate profit. The FDA should dismiss both applications and encourage the development of medical products made from more suitable materials. A minimum requirement should be that such materials are not derived from tissue taken from infant patients who are unable to consent to a highly painful surgery causing a significant lifelong body alteration.

Sincerely,

J. Steven Svoboda
Director