December 16, 2013
Merck Animal Health making "considerable progress" on beta agonist Zilmax audit
Merck Animal Health has been working on its Five-Step Plan to Ensuring Responsible Beef, which will add to the significant amount of data that already exists for Zilmax® (zilpaterol hydrochloride), including numerous animal safety and well-being trials.
Zilmax is a feed supplement in the class of beta agonist approved by the US FDA and other regulatory authorities. The growth-promoting drug is fed to cattle in the final weeks before slaughter to speed up weight gain and make meat leaner. The sale of the beta agonist was suspended by Merck Animal Health in August this year, after Tyson and Cargill stopped the use of Zilmax due to the potential health and behavioural problems it poses on cattle.
According to Merck Animal Health, despite "considerable progress" made over the last 90 days, "it is too early to determine when Merck Animal Health will return Zilmax back to the market in the United States and Canada."
Meanwhile, in order to help further ensure safe and effective product use by customers, a formal certification process has been developed. As part of the certification, every feedyard team member, nutritionist and veterinarian who uses Zilmax or provides consultative services on feeding Zilmax to cattle must be trained annually on the proper use of the product.
The training will focus on safety practices, product handling, mixing protocols, cattle management, product inventory, record keeping and clean-out procedures. Every certified operation will also be required to pass an initial homogeneity test to ensure proper mixing practices, as well as four additional feed mix tests throughout the year. Before a feedyard can participate in the Zilmax Field Evaluations, the operation will need to be certified.
In addition to implementing the certification process, the company has also worked with its advisory board to develop and finalise the protocol for the field evaluations for Zilmax-fed and control cattle (previously noted as "scientific audit"), which are expected to begin in Q1 2014.
Guiding principles of the field evaluations include observing cattle throughout the system- before and after receiving Zilmax - at the feedyard and at the packing plant; evaluating the mobility of cattle by trained third-party experts utilising an established mobility scoring system; and reviewing potential compounding factors, such as nutrition, transportation, receiving facilities, flooring surfaces, and cattle management and handling practices.
The field evaluations will take place with the oversight of a well-known independent epidemiologist and veterinarian, who will serve as principal investigator and collect all data, analyze results and publicly communicate findings in support of the company''s commitment to transparency and communication.
"We at Merck Animal Health remain highly confident in the safety of Zilmax, which is supported by the results of more than 30 studies, totalling 65,000 cattle that were conducted by well-respected universities and third-party experts," said KJ Varma, BVSc, Ph.D., Senior Vice President Global R&D, Merck Animal Health.
Dr Varma added, "We believe the field evaluations we are conducting as part of the five-step plan will support the results of previous studies and the safety of the product, and we are confident that they will help create a greater understanding of the best management practices that are so vital to helping ensure the well-being of cattle."
"At Merck Animal Health, we continually evaluate our processes and procedures across the entire company to ensure that we maintain the best science-based practices and procedures for the health and well-being of animals," says Dr Varma.
The Five-Step Plan to Ensuring Responsible Beef was developed with the input and oversight of its advisory board, which was formed in August. The Merck Animal Health Advisory Board is comprised of representatives from packers, large, medium and small cattle feeder operations, cow-calf producers, veterinarians, academia and industry consultants. The Advisory Board has provided input on, reviewed and approved all initiatives in support of the plan.
The board aims to help the company maintain an open dialogue on animal well-being, beta agonist use and related matters; review all available animal safety and well-being research data on Zilmax; review the existing Zilmax Quality Assurance program (ZQA) and make recommendations as needed; provide input on the certification and scientific audit processes; and review and provide guidance on best management practices for using Zilmax.
Meanwhile, in November this year, a new certification is available to American beef or pork suppliers that want to market their products as never fed beta agonists and free of beta-agonist residues, according to the USDA''s Agricultural Marketing Service.