The entire 1/15/02 FSIS Thinking Paper

This FSIS thinking paper addresses additional measures to "minimize human exposure to BSE agents in the unlikely event that it is introduced in the U.S".    A notice of the availability of this paper and (sort of)  request for comments was published in the [Federal Register: on 1/17/02 (link to that)  The paper provides a good, concise overview of BSE and USDA actions as of the first of '02.

Subsequent actions listed in a 1/15/03 USDA press release:

    In June 2002, FSIS announced proposed revisions to existing directives to strengthen AMR systems. A rule was finalized in December 2002, instructing inspectors at beef establishments using vertebral columns as source materials in AMR systems to take routine regulatory samples to verify that spinal cord is not present in AMR product. If spinal cord tissue is present, then the product does not meet FSIS labeling and inspection requirements for meat.

     FSIS expects to issue a Notice in the Federal Register by August 2003 to solicit additional comments on a proposed rule on meat derived from AMR systems. FSIS will seek these additional on a recently completed survey regarding AMR systems using beef vertebral columns as source material. The proposed rule will clarify that vertebral column should not be used as a source material unless the establishment has effective process control measures in place to ensure that central nervous system tissue is not present in meat derived from AMR systems. A final rule is expected on AMR by December 2003.

     Rule to Prohibit Use of Certain Stunning Devises: FSIS is working to complete a direct final rule by March 2003 prohibiting the use of air-injection stunning devices used to immobilize cattle during slaughter. In this rulemaking, FSIS will address the risk posed by stunning devices that may inadvertently force visible pieces of brain and spinal cord tissue, known as macro-emboli, into the circulatory system of stunned cattle.

     Publish an Advance Notice of Proposed Rulemaking (ANPR) to consider regulatory options for disposal of dead stock on farms and ranches: FSIS expects to issue a Notice in the Federal Register in February 2003 directing people who deal with dead, dying, disease and downer animals that they are required to register with FSIS. The Notice is being issued to assist with traceback if BSE were detected and to assist FDA in enforcing its feed ban. In February 2003, APHIS also plans to issue an ANPR to consider additional regulatory options for the disposal of dead stock on farms and ranches. Such cattle are considered an important potential pathway for the spread of BSE in the animal feed chain.
 

The synopis of the Havard risk assesssment (RA) is very good- "...shows that the US is is "highly resistant" to any introduction of BSE and that BSE is extremely unlikely to become established in the U.S. If BSE should enter the U.S., the assessment indicates that most probably, only a small amount of potentially dangerous tissues would reach the human food supply."  Also the RA did not quantitive liklehood of humans developing vCJD or exposure via "some pharmaceuticals, gelatin, and beef stocks, extracts, and flavorings".  The results of the RA indicate 3 primary means for the spread of BSE and introduction to humans:

Noncompliance with the FDA feed ban, including misfeeding on the farm and the mislabeling of feed and feed products prohibited for consumption by cattle.

Rendering of downer cattle, including cattle that die on the farm.

Inclusion of high-risk tissue, such as brain and spinal cord, in edible products.

The paper notes date from Eurpoe indicates that downers have a higher rate of BSE but that the typical clinical signs of BSE cannot always be detected in downeres which have BSE and gives a good description of the then current regs. on downer cattle:

In the U.S., cattle with clinical signs of a CNS disorder and cattle that died otherwise than by slaughter are already prohibited for use as human food. All downer cattle presented for slaughter are automatically suspected of being affected with a disease or condition that may require condemnation of the animal, in whole or in part, and are identified as "U.S. Suspects." Such cattle must be examined by an FSIS veterinarian and a record of the veterinarian’s clinical findings must accompany the carcass to post mortem inspection if the animal is not condemned. Postmortem inspections on the carcasses of downer cattle must be performed by a veterinarian rather that a food inspector and the results of this inspection must be recorded as well.

Then:  "Although the muscle tissue from BSE-infected downer cattle would not contain the BSE agent, other tissues, identified above, could and the muscle tissue could be cross-contaminated at slaughter and processing."

Also notes that APHIS is increasing the number of downers it tests for BSE and evaluating the need for more extensive testing and is " considering developing requirements for the disposal of dead and downer cattle on the farm that would ensure that the BSE agent, if present in these cattle, would not be recycled to expose other animals."

"Designate brain and spinal cord from cattle aged 24 months and older and downer cattle regardless of age as SRMs and prohibit their use for human food".....  "Designate intestine from all cattle regardless of age as an SRM and prohibit its use for human food"  Later in the paper, the cost evaluation includes:  "There are approximately 484 very small establishments that slaughter cattle aged 24 months and older. The regulatory burden may be the most significant for these very small establishments. .
"
"Prohibit the use of the vertebral column from downer cattle regardless of age (and consider other populations of cattle, including all aged 24 months and older), as a source material in meat recovery systems that use pressure to separate beef meat or beef products from bone."  Later in the paper  "Establishments may incur a net yield reduction of up to 4 pounds of boneless meat per vertebral column.   Net loss of boneless meat produced using AMRS may be as high as 25 million pounds per year valued at $17 million (based on an estimate of the number of downer cattle and cattle aged 24 months and older offered for slaughter; FSIS does not yet have a refined estimate of the various populations of cattle used in AMRS production)  "

"Prohibit the use of cheek meat from cattle aged 24 months and older and downer cattle regardless of age for human food if the meat is not removed before the skull is fragmented or split."

On the positive side, the announced new rules designates as SRM  much was proposed in this papermore than was proposed by FSIS in '02 (espically noteworthy is the vertebral column, and dorsal root ganglia).  But, again, only from cattle older than 30 months vs. the 24 in the FSIS paper.  .

The paper requested comments and states FSIS will do an evaluation and may publish a proposed rule in the FR but, if BSE is found in the US before that, a emergency interim rule may be issued.  and notes that any such FSIS rule "....would address the need for: sanitation requirements for equipment that has come in contact with a BSE-infected animal; nationwide versus regional implementation of emergency measures; and the identification of all cattle aged 24 months and older offered for slaughter".  The announcement of the new rules did not include  the above sanitation requirement..   <Was a rule ever proposed?>

The paper also list aditional options that could support FDA and APHIS:

Option 1: Increase enforcement of FSIS’s record keeping and registration requirements for renderers and persons who engage in the business of buying, selling, and transporting dead, dying, disabled, or diseased livestock (4-D), or parts of the carcasses of any such livestock that died other than by slaughter.

Option 2: Require that all cattle offered for slaughter be accompanied by a written certification by the cattle supplier that states that, to the best of the supplier’s knowledge, the cattle have not been fed materials prohibited by FDA’s regulations during their lifetime.

Option 3: Implement measures that will be consistent with any policy that FDA adopts on the disposition of cattle that have been fed prohibited materials

Option 4: Where necessary, revise the FSIS regulations that prescribe handling and transportation requirements for inedible products to ensure that inedible materials that contain SRMs are disposed of in a manner that will prevent such materials from being incorporated into or used to manufacture FDA-regulated products.

Option 5: Revise the FSIS regulations that prescribe handling and transportation requirements for dead, dying, disabled, or diseased livestock to ensure that the carcasses of dead and downer cattle that are condemned on ante-mortem inspection are disposed of in accordance with any policy on the disposal of dead and downer cattle on the farm that APHIS may develop, and to provide for a sufficient number of animals to be tested by APHIS for BSE.

.... FSIS has requested that Harvard assist FSIS in using the risk assessment model to evaluate
the policy options discussed in this paper and alternatives. FSIS will use the results of the additional modeling to refine the policy options
under consideration, to determine the effectiveness of measures in reducing the risk of potential exposure to the BSE agent, and to
evaluate the benefits of various alternatives. :

The measures that FSIS will evaluate with assistance from Harvard include:

• Prohibiting the use of bovine intestine for human food.
• Prohibiting the use of vertebral column as a source material in meat or meat food product recovery systems that use pressure to separate beef meat or beef meat food product from bone for cattle older than 24 months.
• Prohibiting bone-in-beef for human food from cattle older than 24 months.

FSIS may also evaluate additional measures using the Harvard risk assessment including the following:

• Prohibiting the use of brain and spinal cord for human food;
• Prohibiting the use of the head, except the tongue, for human food;
• Prohibiting the use of bovine vertebral column in the production of human food;

Prohibiting the slaughter of cattle older than 24 months of age (other ages, such as younger or older than 24 months, could be considered).