[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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