Docket No. 97-093-7
Docket no. 97-093-5
Regulatory Analysis and Development
4700 River Road, Unit 18
Riverdale, MD 20737-1238
We are commenting on the Scrapie Eradication uniform Methods and Rules document and, where indicated, the Final Rule on 9 CFR Parts 54 and 79 “Scrapie in Sheep & Goats; Interstate Movement Restrictions and Indemnity Program”. We realize that the comment period is closed on the Final rule, however some of our comments on the UM&R pertain to the rule and we encourage APHIS to consider them for a revision to the rule.
We compliment APHIS for publishing the Final Rule on interstate movement restrictions; to eradicate scrapie from our nation’s flock will be valuable to international competitiveness and trade. We also appreciate the efforts by APHIS to seek input from the States and industry on the operational aspects of the eradication program by making the draft UM&R widely available. In the future, rather than using the formal notice and comment process through the Federal Register, we encourage the agency to seek input and collect comments on a more informal but objective and methodical basis through industry and State meetings and through an annual review process as is proposed in the draft UM&R. We do, however, urge APHIS to publish revisions to the UM&R on a regular basis or when the document is being changed in order for all stakeholders to understand current requirements and expectations and have the opportunity to provide input.
We appreciate the extensive changes that were made as a result of the comments to the Proposed Rule. The recognition of Brand Inspection laws, the extensive nature of the management systems in our commercial industry, the establishment of low-risk categories, the new and emerging diagnostic tools and the added flexibility in determining values for indemnification and slaughter-channel movement and others are all changes that will help the overall eradication process.
We urged APHIS in our comments to the proposed rule to base breeding sheep identification requirements on their premises of birth/origin. APHIS acknowledges, “Numerous commentaries requested that we acknowledge that some forms of premises identification could satisfy the proposed requirement for identification of animals moving interstate”. However, APHIS chose to require unique animal identification numbers as a part of the premises identification in most cases for the purpose of: “allow trace back of individual animals at any point in interstate commerce”. Yet, the published requirements for recording and tracking unique animal numbers does not add trace back capabilities beyond what would have been achieved through premises identification alone. We appreciate the desire for individual animal identification from a flock epidemiological standpoint. However, the identification number itself is of little use without corresponding flock records showing parentage, contemporary lambing groups and other management factors which are not and should not be required by government. For this reason, we feel that requiring unique individual animal identification is unnecessary and places an undue burden on the eradication program through added costs and record keeping. Thus, we urge APHIS to reconsider this issue and amend the Final Rule in such a manner that requires only a premise identifier.
We appreciate the changes made to the definition of High-Risk Animal, specifically the focus on breeding animals and consideration of the completion of a flock plan. We question, however, the exclusion of “male sheep that have tested RR at codon 171 and AA at codon 136”. First, elsewhere in the definition, “an exposed female sheep that has not tested QR, HR or RR at codon 171” is considered High-Risk thus the genotypic risk requirements for rams are higher than for ewes. Second, it is widely recognized in the scientific literature that rams pose little or no risk in transmitting scrapie to other sheep. This is generally recognized by the agency since a single scrapie diagnosis in a ram in a flock does not constitute infected-flock status in that flock. We believe that an exposed intact male sheep (ram) should not be considered High-Risk regardless of its genotype at codon 171 or 136 unless there is published scientific evidence documenting such risk. Therefore, we urge APHIS to amend the Final Rule to reflect the low-risk status of rams.
Several places in the rule and UM&R describe risk pertaining to genotype at both codon 171 and 136. We are familiar with the literature describing genetic susceptibility and resistance at codon 136; however this applies to exposure to “strain-A” scrapie. We are not aware that strain-A scrapie has ever been documented in the United States. Therefore we believe that it is appropriate to concentrate on susceptibility and resistance at codon 171 since we do have strain-C scrapie until/unless strain-A is found in a natural case in the United States. We therefore urge APHIS to amend the final rule to remove all references to codon 136. Doing so will lessen the financial burden on producers and simplify the regulatory process.
The ultimate goal of the eradication process is, of course, to completely eradicate scrapie from the United States. Upon completion of the national scrapie slaughter surveillance study and as the eradication program progresses, there will be States and zones that will be in a position to document their improving or free status. The UM&R addresses this in Part IV-B. While the intention seems to be consistent with the goal stated above, we believe that Part IV-B should be simplified and streamlined into no more than four stages before reaching a free stage level. We also disagree with several of the concepts and requirements published in the draft. These are:
- Semen and rams do not pose a significant risk to other animals; although it is not a proven risk, we believe that semen from infected animals should be prohibited.
- Ruminant derived protein is not legal to feed to sheep and is regulated by FDA; thus it should not be considered an issue here.
- The scrapie status in States or zones outside the one under consideration should not be a factor so long as the stated movement requirements are being met.
Following is our recommended procedure: Stage I
Require that a State or Zone has met all the requirements of Consistent State status. Conduct an active surveillance program that provides at least a 95% confidence of detecting 0.1% prevalence of scrapie in animals that show signs of a wasting or neurological condition. Stage II
Has met stage I requirements for at least 12 months and has had a prevalence of less than 0.1 % during that time. Prohibits animals and embryos from animals that have been exposed to scrapie. Prohibits semen from infected animals. Permits female animals and embryos entry only from Stage II or higher States, zones, or countries or from certified free flocks. These entry restrictions do not apply to wethers, animals for immediate slaughter, or for feeding, prior to slaughter, in a terminal feedlot. Stage III
Has met stage II requirements for at least 12 months and has had no cases of scrapie in animals born in the State or Zone in the preceding 12 months. Prohibits animals and embryos from animals that have been exposed to scrapie from entering the State or zone. Prohibits semen from infected animals. Permits female animals and embryos entry only from Stage III or higher States, zones, and certified free flocks. These entry restrictions do not apply to wethers, animals for immediate slaughter, or for feeding prior to slaughter in a terminal feedlot. Stage IV
Has met all stage III requirements for at least 60 months and has had no cases in animals born in the State or zone during the preceding 60 months. Permits animals and embryos entry only from Stage IV or higher States, zones, and certified free flocks. These entry restrictions do not apply to wethers, animals for immediate slaughter, or for feeding prior to slaughter in a terminal feedlot. Free Status
After fulfilling the requirements for stage IV, a State or Zone is required to apply to the Veterinary Services National Animal Health Programs staff for approval. The application must be jointly signed (original plus two copies with original signatures, including the required documentation), by the State animal health official for each State in the zone and the area veterinarian-in-charge (AVIC) assigned to the State or zone. If the application is accepted, the recommendation to designate the applying State or zone as having scrapie-free status will be evaluated and approved by APHIS in accordance with the requirements in 9 CFR 79.6.and subsequent published in the Federal Register. Prior to final approval and upon the acceptance of the application, APHIS will publish a notice in the Federal Register to the intent to designer the State or Zone as free. Comments to this notice will be used by APHIS in the final evaluation process.
Section IV-C describes the procedures for status change. We appreciate the agency’s efforts to consult industry and States through the proposed formation of a National Scrapie Regulatory Issues Group. However, we believe that the formation of and consultation with such a group should not substitute for the more formal notice and comment system providing for unrestricted input.
We also note that slaughter surveillance in not addressed as a mechanism through which States and zones can progress in status. We believe that slaughter surveillance can be a useful mechanism for disease detection as well as for the documentation of status. We therefore urge APHIS to recognize slaughter surveillance as valid methodology and to build appropriate statistical sampling protocols into status documentation and progression as an optional system for States and zones. Likewise, third-eyelid testing could be a very valuable surveillance tool if used in a similar manner. The test’s very high specificity should provide a very accurate picture of disease presence. The sensitivity is lower yet nearly 90% and; if, for example, two year-old and older animals were sampled twice, high assurance of disease absence would be attained.
In conclusion, ASI is on record urging APHIS to allocate an adequate number of well-trained, full-time personnel to scrapie eradication. We also continue to urge APHIS to allocate sufficient resources to training and education of the federal field force in tissue collection for diagnostic submissions as well as general information to the industry on disease recognition and compliance. APHIS has proposed a reasonable time-line for States to reach full compliance. We believe that federal resources can be used most efficiently if the following issues are listed as priorities for compliance:
- Premises identification at the flock of birth for breeding sheep
- Adequate federal field staff and appropriate training
- Industry education and information
ASI will continue to commit its resources in the interest of assisting APHIS with the eradication effort and we look forward to the opportunity to represent industry and work with federal and State partners to eradicate scrapie from the United States.
Frank Moore, President