The CDC has updated its regulations regarding human tissues and remains being imported into the United States. These new regulations, which go into effect on August 15, 2020, will allow legitimate human remains to get back to the United States for burial, cremation or entombment, while requiring body brokers to transport their materials in accordance with any other biological material used for teaching purposes. NFDA lent its expertise in developing the final regulation.
Background
Some time ago – pre-COVID-19 – the CDC began the process of examining issues related to improper embalming of tissues/bodies being shipped into the United States.
The CDC’s role is to ensure that human remains imported into the United States do not threaten public health. In recent years, CDC has recorded an increasing number of attempts to import improperly packaged body parts, or body parts that lack the required documentation. These body parts are generally imported for purposes other than burial, entombment, or cremation, and may include science, exhibition, or education.
The CDC opened the federal regulation for comment and just released their final rule last week after the open comment period closed.
What Changed?
You can read the new regulation, Importation of Human Remains Final Rule, here https://www.cdc.gov/importation/laws-and-regulations/human-remains-importation-requirements.html.
- Renamed 42 CFR §71.55 from “Dead Bodies” to “Importation of Human Remains” to clarify that the regulation covers body parts as well as whole human cadavers.
- Added new definitions to 42 CFR §71.50 for “death certificate,” “human remains,” “importer,” and “leak-proof container.”
- Death certificate—An official government document that certifies that a death has occurred and provides identifying information about the deceased, including (at a minimum) name, age, and sex. The document must also certify the time, place, and cause of death (if known). If the official government document is not written in English, then it must include an English language translation of the official government document. A person licensed to perform acts in legal affairs in the country where the death occurred, such as a notary, must attest to the document’s authenticity. In lieu of a death certificate, a copy of the Consular Mortuary Certificate and the Affidavit of Foreign Funeral Director and Transit Permit, shall together constitute acceptable identification of human remains.
- Human remains means a deceased human body or any portion of a deceased human body, except:
- Clean, dry bones or bone fragments; human hair; teeth; fingernails or toenails; or
- A deceased human body and portions thereof that have already been fully cremated before import; or
- Human cells, tissues or cellular or tissue-based products intended for implantation, transplantation, infusion, or transfer into a human recipient.
- Importer means any person importing or attempting to import an item regulated under this subpart.
- Leak-proof container means a container that is puncture-resistant and sealed in such a manner as to contain all contents and prevent leakage of fluids during handling, storage, transport, or shipping, such as
- A double-layered plastic, puncture-resistant body bag (i.e., two sealed body bags, one inside the other);
- A casket with an interior lining certified by the manufacturer to be leak-proof and puncture-resistant; or
- A sealed metal body-transfer case.
- Required that human remains imported into the United States, or in transit within the United States and not intended for import, be fully contained within a leak-proof container that is packaged and shipped in accordance with all applicable legal requirements.
- Clarified that importers entering the United States with human remains known to contain or reasonably suspected of containing an infectious biological agent must comply with 71.54.
- Eliminated specific requirements under former §71.55 that human remains of a person who died of a quarantinable communicable disease be “embalmed” and placed into a “hermetically sealed casket” because these terms no longer reflect current best practices and unnecessarily increase the burden on importers.
- Required that human remains imported for burial, entombment, or cremation be transported directly to a licensed mortuary, cemetery, or crematory. This provision ensures that human remains enter only for the intended purpose and are immediately transferred for final disposition and also ensures that the human remains are not re-exported.
- Required that, unless embalmed, human remains imported for burial, entombment, or cremation must also be accompanied by a death certificate listing the cause of death (if known).
- CDC understands that certain countries do not state cause of death on a death certificate due to privacy concerns. For this reason, also under §71.55(c)(1)(ii), if the death certificate is incomplete or missing, the human remains must be accompanied by:
- An importer certification statement confirming that the human remains are not known to contain, or are not reasonably suspected of containing, an infectious biological agent; OR
- A permit issued by the CDC under 42 CFR §71.54 if the human remains are known to contain or reasonably suspected of containing an infectious biological agent.
- Required that, unless embalmed, human remains imported for medical examination or autopsy be consigned directly to an entity authorized to perform such functions under the laws of the applicable jurisdiction before subsequent burial, entombment, or cremation; and include a death certificate or, if the death certificate is incomplete or missing, an importer certification statement or permit under 42 CFR §71.54.
- Required that human remains imported for any other purpose, unless embalmed, must be accompanied by an importer certification statement or permit under 42 CFR §71.54. This language addresses the other uses for human remains such as medical training or anatomical display.
- Added clarifying language that specifies the differences in documentation needed between human remains imported for direct burial, entombment, or cremation (§71.55) and human body parts primarily imported for other purposes (71.54 Import regulations for infectious biological agents, infectious substances, and vectors).
- Finally, under §71.55(d), imported human remains may be subject to suspension of entry under 42 CFR §71.63 if CDC determines that such an action is necessary to protect the public’s health. In the past, this provision has only been invoked to temporarily suspend importation of animal reservoirs of zoonotic disease. HHS/CDC does not anticipate this provision will be invoked frequently absent a public health emergency where such measures would be needed to protect US public health.
Helpful Links