April 22, 2014 

Docket Number APHIS 2009-0017
Regulatory Analysis and Development
PPD, APHIS, Station 3A-03.8
4700 River Road, Unit 118
Riverdale, MD 20737-1238
RE:      Docket Number APHIS 2009-0017, Importation of Beef from a Region in Brazil
To Whom It May Concern:
The North Dakota Stockmen’s Association (NDSA) is an 85-year-old trade organization that represents nearly 3,000 cattle ranchers in North Dakota. The NDSA appreciates the opportunity to comment on the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service’s (APHIS) proposed rule regarding the importation of fresh, maturated, deboned beef from a region in Brazil into the United States. The NDSA is also an affiliate of the National Cattlemen’s Beef Association, and supports the comments submitted by that organization, which include findings obtained through an objective, third-party, scientific review team from the University of Minnesota’s College of Veterinary Medicine’s Centers for Animal Health and Food Safety and Veterinary Population Medicine.
The NDSA is committed to protecting the health and well-being of the U.S. cattle herd and providing safe and wholesome beef products for consumers around the world. While we support import rules based on scientifically derived principles that are consistent with the World Organization for Animal Health (OIE) guidelines, we do not support APHIS’ proposed rule to allow for the importation of fresh beef from Brazil into the United States. After reviewing the proposed rule, risk analysis, regulatory impact analysis and related supporting documents, we are not convinced that Brazil has the resources, infrastructure or will to consistently perform adequate risk management steps in order to mitigate the risk of foot-and-mouth disease (FMD) entering the United States through the importation of fresh Brazilian beef. FMD is considered one of the most serious transmissible diseases of cloven-hooved animals – cattle, bison, swine, sheep, goats, deer, elk, antelope, etc. The direct impact on animal health and productivity and the indirect implications for personal livelihoods and the loss of trade and economic well-being make the prevention of FMD spread critically important, and this proposed rule particularly dangerous.
The United States has not had a case of FMD since 1929 – 85 years ago. In contrast, the last outbreak of FMD in the proposed export region of Brazil occurred in 2006 – just eight years ago. According to the literature of 627 documented FMD outbreaks from 1870 to 1963, nearly 70 percent of the outbreaks were caused by the legal or illegal importation of infected animals or animal products. Consequently, adequate import controls and quarantine procedures for live animals and the proper risk analysis of the dangers associated with the importation of animal products from FMD-affected areas are essential.
The risk analysis for FMD risk with the importation of fresh, maturated, deboned beef from Brazil conducted by APHIS and published in December 2013 appears to have been based on five site visits to the export region under consideration in 2002, 2003, 2006, 2008 and 2013. We are concerned that not all of the factors for animal health status were reviewed at each of the site visits by APHIS. Even more concerning is the fact that APHIS indicated that is has no written reports or documentations of the site visits, as the visits are considered reviews, not audits, and has not produced related information (data analysis, reviewer notes, interview notes, etc.) from those visits, despite a Freedom of Information Act request by our national organization for that information more than two months ago. There does not appear to be an established protocol to allow for consistency and quality assurance in these APHIS site reviews, and it unclear from the risk analysis which data was verified through Brazil’s documents and which was verified through APHIS site reviews, which is counter to the OIE’s Terrestrial Animal Health Code that calls for transparency in the process so there is a clear distinction between facts and analysts’ judgment calls.
The OIE Terrestrial Animal Health Code also outlines necessary steps and requirements regarding release assessments, exposure assessments and consequence assessments, which appear to be lacking in the risk analysis accompanying the proposed rule.
In the release assessment, for example, the biological pathways necessary for an importation activity to introduce pathogenic agents into a particular environment and the probability of the disease occurring are not clearly identified. The NDSA is particularly concerned about the risk of reintroduction of FMD into the proposed export region of Brazil since the country has a large, border area with at-risk neighboring countries that is difficult to manage; it has a history of FMD outbreaks even under systematic vaccination; other Brazilian regions, such as Amazonia, do not have sufficient FMD controls in place; and there are possibilities of illegal movement of animals into the export area. By APHIS’ own admission, international border crossings in Brazil are not always manned by both countries and not all crossings are visited. If the proposed rule would be adopted, we would expect that there would be greater market opportunities and higher prices offered in the export region and that that could very well add to the number of illegal animal movements in the region. The role of wildlife in FMD transmission is likewise minimized in the release assessment, yet those statements appear to be based solely on the opinion of Brazilian animal health officials and lack supportive scientific literature. The wildlife interface is of great concern to animal health officials in this country.
The exposure assessment only identifies a single exposure pathway: the feeding of FMD-contaminated beef to susceptible animals. There is no discussion of alternative pathways, such as illegal imports. It is necessary for the assessment to be expanded to include other possibilities.
The NDSA contends that a quantitative risk analysis, that would have provided a numeric estimation of the probability of risk and the magnitude of consequences, should have been conducted instead of the qualitative risk analysis, which tends to be more subjective, that was conducted. Why wasn’t APHIS consistent in its risk assessment approaches regarding the importation of fresh beef from Brazil and Uruguay, especially since those countries share the same FMD-risk designation from the OIE?
The NDSA is concerned – and APHIS should be too – with Brazil’s repeated compliance failings with U.S. Department of Agriculture Food Safety Inspection Service (FSIS) audits aimed to ensure compliance with the Federal Meat, Poultry Products and Egg Products Inspection Acts. Review of Brazil’s performance in FSIS audits over a 10-year period from 2003 to 2013 documents the country’s inability to execute a consistent program with adequate oversight. Serious deficiencies and outright failings have been identified over the years, ranging from lack of government oversight; inspector conflict-of-interest issues; laboratory operation shortcomings; establishment operation concerns; adulterated products; and residue compliance issues. Issues have been so prevalent that Brazil has “self-suspended” all of their slaughter establishments certified to export to the United States three times between 2005 and 2010. The country’s failure of control in equivalency measures suggests that it would have a similar inability to execute risk management measures necessary to manage the risk of FMD entering the United States through the importation of fresh beef from the proposed export region.
Similarly, Brazil has not demonstrated its ability to promptly report diseases, as evidenced following the death of a BSE-infected animal in December 2010. Initial testing of the animal was done in early 2011 and produced test results suspicious for BSE. Confirmation of BSE in that animal was not reported to the OIE until July 2012. Brazil was reprimanded for the 18-month delay in reporting and the delay in sending the appropriate samples to the OIE Reference Laboratory for confirmation. Equally concerning is the reason Brazil cited for its delays: laboratory overload in Brazil. There are no assurances that the “overload” problem has been rectified, and that Brazil would identify and report a case of FMD swiftly either. In February 2013, OIE requested detailed information from Brazil about the processes it has in place for managing lab samples, and cautioned Brazil that it would be monitoring it for improvements in its surveillance system for identifying and reporting animal diseases. The country also received low marks in audits by the European Commission, which regularly audits foreign countries exporting to European Union nations regarding animal movement controls, adequate maintenance of slaughter facilities, animal welfare and residue compliance issues.  
In a briefing about FMD, the OIE indicates that the incubation period between infection and the onset of clinical signs of FMD ranges from two to 14 days, depending on the dose, but that it is most commonly three to five days. The document also indicates that the virus may be present in a variety of tissues, bodily fluids and excretions prior to the onset of clinical signs, and cattle and hogs usually exhibit obvious clinical signs, but they are often less recognizable in small ruminants. The virus persists longer at the site of the lesions and, in a high proportion of cattle, low levels of the virus can be detected orally beyond 28 days after infection. In some cases, it can be detected up to 3.5 years after infection, meaning they are FMD virus carriers. The incubation period is why OIE recommends a three-week quarantine period for animals intended for slaughter and export, and that makes sense to us. Unfortunately, the proposed rule does not include a requirement for any quarantine, which is disturbing to our producers.
We contend that the regulatory economic impact analysis conducted by APHIS indicates only the economic impact of the estimated 40,000 metric tons of fresh beef from Brazil on the U.S. domestic market, and this is only a fraction of what the economic ramifications of the proposed rule could be. A balanced and legitimate economic analysis would also account for the possible risk of the introduction of FMD into the United States, which would easily be in the billions of dollars.
Because it is evident that Brazil cannot be relied upon to uniformly execute the necessary risk management steps needed to sufficiently mitigate the risk of FMD introduction into the United States, we urge APHIS, which has a mission “to protect the health and value of American agriculture and natural resources,” to withdraw this proposed rule. The risk to the U.S. beef industry and other agricultural sectors is much too great and the consequences much too significant to move forward with it.
Thank you for the opportunity to comment. If you have any questions, please contact our office at (701) 223-2522.
Jason Zahn
North Dakota Stockmen’s Association