AN application to register a beta agonist medicated pre-mix product for use in Australian grainfed beef cattle for the first time is polarising views within the industry.
MSD Animal Health has lodged an application for the registration of its beta agonist product Zilmax, with the Australian Pesticides and Veterinary Medicines Authority (APVMA) – the government regulator for agricultural and veterinary chemical products.
Before approving an active constituent and/or registering a product, the APVMA must be satisfied that the statutory criteria – including the product’s safety, efficacy, trade implications and labelling criteria – have been met.
The application for Zilmax is currently under APVMA’s evaluation, and has now reached the public consultation phase (more details below).
The Australian Lot Feeders Association is in support of the registration, while the Australian Meat Industry Council, representing processors, and the grassfed industry, through the Cattle Council of Australia, are opposed to the introduction of beta agonists to Australia, on a range of grounds.
Beta agonists are currently registered for use in the Australian pork industry, but have never been approved for use in Australian beef. MSD’s product, which it describes as a ‘medicated premix’, uses the active ingredient Zilpaterol hydrochloride, a beta II-adrenergic agonist.
The product is used during the last 20 days on feed in the lotfeeding industry for improved rate of bodyweight gain, increased skeletal muscle content, increased carcase leanness, increased dressing percentage, and improved feed efficiency.
Zilmax (and in some cases, other beta agonist products) are registered for use in 16 countries around the world, including the US, Canada, Brazil, Colombia, Costa Rica, Dominican Republic, Guatemala, Honduras, Kazakhstan, Mexico, Nicaragua, Panama, Peru, South Africa and South Korea. The compounds are not currently permitted for use (or in imported beef) in countries including China, the European Union and Taiwan.
There is a lengthy history of animal health companies seeking to register beta agonists for use in the Australian beef industry, but Beef Central understands this is the first to reach the formal approval stage for beef cattle.
To support its registration bid, MSD Animal Health has provided extensive and detailed data packages on chemistry and manufacture, human safety, target animal safety, metabolism, residues and trade, environment and efficacy.
“As with all other Agvet chemical applications, the APVMA registration process for Zilmax involves a thorough scientific evaluation of the product in order to ensure the health and safety of people, animals and the environment,” the Authority said.
Overseas trade considerations
APVMA said export of treated produce containing measurable residues of zilpaterol may pose a risk to Australian trade in situations where no residue tolerance is established in the importing country, or where residues in Australian product are likely to exceed a residue tolerance established in the importing country.
The zilpaterol MRLs established in Japan, Korea and the US were higher than that proposed for Australia, and the potential risk to trade to these markets was considered to be low and acceptable, the authority said.
An Export Slaughter Interval equal to the proposed four-day meat withholding period was considered to be appropriate for these three major export markets. MRLs are not established in the EU, China or Taiwan.
“Codex MRLs are not established which means that many countries that may adopt Codex MRLs do not have appropriate MRLs,” the APVMA said. “An Export Slaughter Interval for these markets cannot be established as residues did not decline sufficiently in livers or kidneys at the last time point of 10 days. Residues above a critical point were, however, not observed in muscle or fat at 5-10 days after the last treatment.”
“Therefore finite residues are not expected to occur in meat following five days of withdrawal,” the authority said.
Divergent industry views
While the Australian Lot Feeders Association is in support of the Zilmax registration, provided it meets the authority’s oversight, discussions with a range of other beef supply chain stakeholders clearly showed there is opposition to the move, on a range of grounds.
ALFA chose not to participate in an interview with Beef Central on the topic, but issued the following statement:
The Australian Lot Feeders Association supports the APVMA role in assessing and registering medicines, vaccines and feed additives that support livestock health and productivity.
The APVMA has a process of assessing new technologies to ensure they are safe for humans, livestock, the environment, and Australian trade and is currently assessing a commercial application for Zilmax medicated premix registration. ALFA will look to APVMA to provide an assurance that this product, and the proposed systems to control its use, is safe for humans, livestock, the environment, and our trade.
The Australian supply chain has appropriate industry systems and regulations in place to ensure the product, if approved, will be used appropriately and in accordance with APVMA and label requirements. Australia, through these systems, has a proven track record of being able to deliver product integrity that meets customer and country requirements.
Beef Central understands that within ALFA ranks, some members (perhaps processor-owned) are opposed to support, while others are in favour.
The Australian Meat Industry Council opposes the Zilmax registration, although individual Australian processors have a range of views. Beef Central sought a response from JBS Australia, the nation’s largest processor (and feedlot operator), over the proposed registration. It provided the following statement:
JBS Australia is aware of the public release summary from the APVMA for the registration of the Zilmax. With respect to perceived trade risks, the Australian beef industry has proven experience and expertise in the management of sensitive trade access requirements and has a proven track record of being able to establish and implement industry systems to manage international trade requirements. Some key examples of these segregation programs that span livestock production through to the processing sector included the EU (EUCAS) system, establishments sourcing of livestock to comply with importing country HGP-free requirements; and establishing sourcing of stock to comply with importing country requirements for cadmium levels in offals, and from PICs with Cotton Trash (CTP) or Cotton Trash Warning (CTW) status.
It is critical that the Australian beef industry remains competitive in global markets and that the industry has access to effective technologies, and the industry is afforded the opportunity to review its processing system and suitability for overseas markets,” JBS said.
Several other large export beef processors (including some operating feedlots themselves) spoken to for this report are opposed to the registration, however, for a range of reasons.
“We oppose the introduction of Zilmax to Australia, regardless of how well it is policed,” a major Queensland processor said. Main reasons for their opposition were:
- Risk of cross-contamination between treated and untreated cattle and beef. As is occasionally demonstrated with HGP use, breakdowns in separation do occur. In the case of HGP, routine palpation for pellets makes it easier to pick-up outliers, but a feed additive product like a beta agonist is much harder to monitor. “It’s not a question about how you monitor those who are doing it correctly – it’s about how you pick up those that aren’t,” a large processor said. One large southern processor lost an entire consignment of beef to the EU some years ago, as a result of cross-contamination of feed in a stockfeeds plant, preparing pig feed containing ractopamine, followed by cattle feed, which picked up a detectable residue.
- Potential market access issues in the event of a breakdown in the management system. The US risked losing the Taiwan export market in a beta agonist residue episode back in 2013, reported by Beef Central. Canada lost access to the China market over beta agonist residue limits a year or two ago.
- Risk of damaging Australia’s ‘clean and green’ image, simply by agreeing to adopt beta agonist growth compounds in beef production. “This is just madness, It is going to be a huge threat to Australia’s clean and green image on the world stage,” one processor told Beef Central. “We sell our product into 70 countries around the world because of our unequalled clean and green image. This is going to put us back into the commodity beef field, rather than the premium beef field. It’s multi-national bastardry by chemical companies, and it couldn’t have happened at a worse time, given what’s happening in the world beef trade.”
- Risk of animal health issues from beta agonists, including added heat-load risk. Some compounds were suspended from use in the US several years ago, after serious animal health issues emerged (click here to view earlier story).
- Potential impact on meat tenderness. Beta agonists have never been analysed under the MSA pathways system, but some overseas studies suggest they have as much impact as HGP.
- Even within markets that might accept beta agonist within accepted tolerances, there will still be consumer resistance from consumers, within those markets, processors and other opponents fear. “Importers would use it to talk us down in price,” one exporter said.
Several processor groups said they planned to lodge submissions the APVMA review, opposing the registration.
Proposed trade management plan
In its submission to the APVMA, MSD proposes a detailed management plan to manage the use of zilpaterol (Zilmax) “efficiently without posing undue risk to efficacy, safety, residue, trade and environment.”
It stressed that the Zilmax product would be sold only to NFAS accredited feedlots.
The plan would work “effectively and collaboratively with existing industry systems,” including the National Feedlot Accreditation Scheme, Approved Arrangements undertaken by processors, the National Livestock Identification Scheme (property and livestock identification) and the National Vendor Declaration System and NFAS delivery dockets (livestock movement advice).
Pending registration, NFAS had agreed to develop a beta-agonist management plan and individual NFAS accredited feedlots would be required to develop feedlot specific QA policies and procedures to ensure the correct use of zilpaterol, it told the APVMA.
“Individual feedlot QA policies and procedures would be audited by NFAS prior to them gaining access to zilpaterol through accredited veterinarians. Feedlots will then continue to be audited by NFAS to maintain zilpaterol approved use status,” MSD said.
Systems would also be put in place to manage the risk of cross-contamination and actions to be taken in the event of accidental access to zilpaterol-treated feed.
Meat processing plants
Under the proposed plan, meat processing plants would follow existing Approved Arrangements procedures that are in place to protect the integrity of products going to sensitive markets using unique carcase destination and product code numbers.
Feedlots would follow documented segregation and identification procedures for zilpaterol treated livestock as agreed with processor partners prior to dispatch.
The APVMA is inviting comment from industry stakeholders until 16 June on whether approval of the active constituent and registration of the product should be granted. Click here to access details for submissions.