• For the Cease order, click Cease Manufacturing Order

California Information:

The following is from California Health And Safety Code Section 1644.5:

• "A recipient of sperm, from a sperm donor known to the recipient, may waive a second or other repeat testing of that donor if the recipient is informed of the requirements for testing donors under this section and signs a written waiver."
   

U.S. Food and Drug Administration (FDA) Information:

 The U.S. Food and Drug Administration (FDA) issued regulations in May of 2005, which require that sperm donors are screened and tested for communicable diseases by FDA-registered facilities and that the screening and testing be done in accordance with FDA-established procedures.

 The following is from the FDA web page at: http://www.fda.gov/BiologicsBloodVaccines/TissueTissueProducts/QuestionsaboutTissues/ucm102842.htm

"Are reproductive cells or tissues donated by a sexually intimate partner screened and tested?"

• "You are not required to make donor eligibility determinations or to perform donor screening or testing for reproductive cells or tissues donated by a sexually intimate partner of the recipient for reproductive use [1271.(a)(2)]. However, special labeling of the HCT/P is required [1271.90(b)]."
   
• [From USC 1271.90] "(b) You must prominently label an HCT/P described in paragraph (a) of this section [(1271.90 a2) ...donated by a sexually intimate partner...] as follows: (b2) "NOT EVALUATED FOR INFECTIOUS SUBSTANCES," (b3) Unless the HCT/P is for autologous use only, "WARNING: Advise recipient of communicable disease risks," (i) When the donor-eligibility determination under 1271.50(a) is not performed or is not completed. "

The following is from the FDA web page at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=1271.15

"Sec. 1271.15 Are there any exceptions from the requirements of this part?"

• "(e) You are not required to comply with the requirements of this part if you are an establishment that only recovers reproductive cells or tissue and immediately transfers them into a sexually intimate partner of the cell or tissue donor."

The following is from the FDA web page at: http://www.fda.gov/BiologicsBloodVaccines/TissueTissueProducts/QuestionsaboutTissues/ucm102842.htm

"What special requirements apply to directed semen donors?"

• "Directed semen donors must be tested at the time of [each] donation, but do not have to be retested 6 months later (as do anonymous semen donors) [1271.85(d)]. The term "directed reproductive donor" means a reproductive donor who knows and is known by the recipient before donation [1271.3(l)]. Reproductive cells or tissues from a directed semen donor who has been determined to be ineligible (e.g. donors who test positive or indicate a risk factor for a relevant communicable disease) are not prohibited from use. Special labeling of the HCT/P [human cell tissue product] is required to indicate increased risk of relevant communicable disease [1271.65(b)]." 
   
• "A six-month quarantine for donations and retesting of directed semen donors is not required [1271.85(d)]. "

U.S. Constitutional Law:

In American Constitutional Law, fundamental rights have special significance under the 14th Amendment to the Constitution. Via the due process and equal protection clauses of that amendment, the Supreme Court has held that some rights are so fundamental, that any law restricting such a right must both serve a compelling state purpose, and be narrowly tailored to the compelling purpose:

• the right to privacy
• the right to marriage
• the right to procreation

fundamental rights are a feature of the U.S. Constitution, which, in the language of the U.S. Declaration of Independence, "all [human beings]" are "endowed by their Creator with certain unalienable Rights, among these [being]:"

1. Life - (cf. right to life)
2. Liberty (cf. freedom, free will, personal liberty)
3. the pursuit of Happiness

The fifth amendment of the United States:

• "No person shall be... deprived of life, liberty, or property, without due process of law"

Trent is a known designated donor and the recipient signs and notarizes understanding of this status in the required Donor Agreement.  Trent's background and identity is freely available to all prospective recipients and their physicians. Trent has been tested against communicable disease and results have been posted online.  Recipients with fertility issues often seek raw, unfrozen semen (unquarantined / uncryopreserved) for possible increased pregnancy odds over frozen semen. Specimens from Trent are labeled with the following:

"FOR IMMEDIATE TRANSFER TO SIP" and "NOT EVALUATED FOR INFECTIOUS SUBSTANCES'' and "WARNING: Advise recipient of communicable disease risks"

Fresh sperm has been shown to increase pregnancy odds over frozen sperm AND suggested to reduce birth defects.   One recipient in her late 30's reported she paid a commercial sperm bank thousands of dollars for a year of frozen sperm inseminations, only to became pregnant with a boy on the 1st try using Trent's free, fresh donor sperm via a local pick-up.