[Federal Register Volume 61, Number 116 (Friday, June 14, 1996)]
[Proposed Rules]
[Pages 30189-30190]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-15173]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Part 95
[Docket No. 89-174-3]
Importation of Fetal Bovine Serum
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Proposed rule; withdrawal.
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SUMMARY: We are withdrawing a proposed rule that would have allowed,
under certain conditions, the importation of fetal bovine serum into
the United States from countries in which foot-and-mouth disease or
rinderpest exists. We are taking this action after considering the
comments we received following the publication of the proposed rule.
DATES: This withdrawal is effective June 14, 1996.
FOR FURTHER INFORMATION CONTACT: Dr. John H. Gray, Senior Staff
Veterinarian, Import/Export Products, National Center for Import and
Export, VS, APHIS, 4700 River Road Unit 40, Riverdale, MD 20737, (301)
734-7837.
SUPPLEMENTARY INFORMATION:
Background
The regulations in 9 CFR part 95 govern importation into the United
States of certain animal byproducts, including blood serum and other
blood products. Blood serum is that part of blood that is left after
the blood cells are removed.
Fetal bovine serum (FBS) is that part of the blood from bovine
fetuses that is left after the blood cells are removed. It is used in
tissue culture media to produce various pharmaceuticals and biological
products, such as vaccines, and cannot be derived synthetically.
On February 25, 1994, we published in the Federal Register (59 FR
9142-9146, Docket No. 89-174-1) a proposed rule that would have
allowed, under certain conditions, the importation of FBS into the
United States from countries in which foot-and-mouth disease (FMD) or
rinderpest exists. The proposed conditions included certification of
the origin of the donor fetuses and treatment of the FBS with gamma
radiation.
We solicited comments on the proposed rule for 60 days ending April
26, 1994. However, on April 15, 1994, we published in the Federal
Register (59 FR 18003-18004, Docket No. 89-174-2) a notice extending
the comment period on the proposed rule until June 27, 1994.
By the close of the comment period, we received a total of 22
comments. One commenter supported the proposed rule as written. Several
commenters supported it with changes. The remainder of the commenters
either opposed the proposed rule or expressed reservations concerning
it.
The commenters in opposition to the proposal raised a number of
issues, including that of the efficacy of the proposed required dosage
of gamma radiation in destroying FMD virus. Several of the commenters
stated that the size and configuration of the containers in which the
FBS is irradiated could influence the effectiveness of the treatment. A
number of commenters stated that the potential difficulties in
adequately monitoring the source of donor fetuses could create an
[[Page 30190]]
unacceptable risk of the introduction of disease into the United
States.
We have considered all of the comments we received on the proposal
and have determined that the expressed concerns have merit. Therefore,
we are withdrawing the proposed rule of February 25, 1994, referenced
above.
Authority: 21 U.S.C. 111, 136, and 136a; 31 U.S.C. 9701; 7 CFR
2.22, 2.80, and 371.2(d).
Done in Washington, DC, this 7th day of June 1996.
Terry L. Medley,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 96-15173 Filed 6-13-96; 8:45 am]
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