Importation of Fetal Bovine Serum

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

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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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