Aug 22, 2006 (CIDRAP News) – US health officials broke new ground last week by approving the use of a mixture of bacteriophages, or bacteria-killing viruses, to control the pathogen Listeria monocytogenes on ready-to-eat (RTE) meat and poultry products.The Food and Drug Administration (FDA) concluded that a mixture of six bacteriophages developed by Intralytix, Inc., Baltimore, is safe to use. The product, called LMP 102, is the first bacteriophage preparation approved for use as a food additive.The product is intended to be sprayed on RTE meats such as sliced ham and turkey. Each of the bacteriophages in it targets various L monocytogenes strains, and the use of six different phages is intended to reduce the risk that Listeria would develop resistance, according to the FDA record of its decision on the product.Phages infect only bacteria and are part of the normal microbial population of the human intestinal tract, according to the FDA. L monocytogenes can grow at refrigerator temperatures and can cause serious illness, particularly in pregnant women, newborns, and people with weak immunity.The phages in LMP 102 are grown in Listeria cultures, the FDA said. In examining the product’s safety, the agency looked at whether it contains any potentially harmful Listeria residues, particularly one called Listeriolysin O (LLO). Investigators did not detect LLO in the product, and mechanisms in the gut would be likely to inactivate any trace amount present.The report also says that some phages can serve to transfer toxin or drug-resistance genes between bacterial cells, but the phages used in LMP 102 are not that kind.The FDA document does not say exactly how effective the product is in reducing Listeria on RTE meats. But John Vazzana, president and CEO of Intralytix, said that in company tests, LMP 102 has reduced Listeria by 99% to 99.9% (2 to 3 logs) on foods with relatively high levels of contamination.”We concluded from those tests that we could basically get rid of 99% of any LM [L monocytogenes] that’s present,” Vazzana told CIDRAP News.He said Intralytix has licensed the product to a multinational company that serves the food processing industry, but declined to name it. “I would think we’re probably 6 months away from the product being used commercially,” he said.The FDA said its action signals only that the product meets the safety standards of the Federal Food, Drug, and Cosmetic Act. The product must also comply with meat and poultry inspection laws that are administered by the US Department of Agriculture (USDA), which require that food additives be “suitable” for their intended use, the agency said.Vazzana said the USDA has been “actively involved” in the FDA review of LMP 102 and that USDA approval is not in doubt. “This is not new to them; they’ve reviewed the petition, they’ve approved the product,” he said.The USDA will be developing guidelines for use of the product, “and that’s a process we’ll be going through over the next several weeks,” he added.Vazzana said the product may have to be listed on food labels, depending on what the USDA decides. He said that shouldn’t scare consumers, given that phages are “the most ubiquitious organisms on the planet today.””I think what we have to communicate to the consumer is that this is an all-natural approach” and that it will affect only Listeria, he said. “We believe this is a much better solution to a serious problem than using hordes of chemicals.”Vazzana estimated that using LMP 102 will add less than a penny a pound to the cost of RTE meat and poultry products.Food safety expert Craig Hedberg, PhD, said he agreed with the FDA that LMP 102 is likely to be safe, but he was cautious in assessing its likely contribution to controlling Listeria. Hedberg is an associate professor of environmental and occupational health at the University of Minnesota School of Public Health in Minneapolis.”Theoretically, phages make a nice control measure, but the real-world application of these products almost always falls short of the ideal situation,” he told CIDRAP News by e-mail.”This seems to be another tool in the toolkit to control Listeria,” he added. “As such, it gives producers a greater range of options on control. The key to Listeria control is the successful integration of the various tools and careful monitoring of the systems to make sure everything is working as it should.”See also:FDA decision record on LMP 102http://www.fda.gov/OHRMS/DOCKETS/98fr/cf0559.pdf
KSPI president Said Iqbal said on Friday that the protest would be held in mid-April, involving 50,000 workers throughout Greater Jakarta in front of the legislative complex in Senayan, Central Jakarta.“We will protest the bill at any risk. If some parties disagree with our activity, just ask the House. They have triggered millions of Indonesian workers, something that does not need to happen amid the pandemic,” he said in a statement.Read also: Key points of labor reform in omnibus bill on job creation: What we know so farHe added that the workers were also not afraid to break the no-gathering policy, which is a part of the government’s efforts to flatten the COVID-19 curve. Topics : “We feel threatened. First, the threat to our lives because we are still working during the pandemic. Second, the threat to our future due to the omnibus bill deliberation.”Civil society organizations, major labor unions and student organizations had previously prepared for street rallies in March to protest articles in the omnibus bill on job creation that — if passed — would harm labor rights, the environment and democracy. They also protested the bill’s less-than-transparent drafting process.However, the rallies were canceled due to the pandemic.Iqbal said deliberating the omnibus bill at a time like this showed that the lawmakers had no empathy for the people.Read also: Omnibus bill’s tripartite forum upsets labor unionsHe said the House should prioritize the handling of the pandemic rather than the omnibus bill.”The omnibus bill is not a solution to the layoff phenomenon during the pandemic. It’s not a solution for Indonesia’s economic growth problems due to the pandemic as well. It is clear that the omnibus bill is not being prepared in anticipation of the effects of COVID-19,” he said.The House on Thursday agreed to begin deliberation of the bill in a plenary session led by House Deputy Speaker Azis Syamsuddin of the Golkar Party, a party in President Joko “Jokowi” Widodo’s coalition.The party, led by Coordinating Economic Minister Airlangga Hartarto, has been the main supporter of the bill. Airlangga had previously visited some party leaders, both in the government coalition and outside in soliciting support for the bill. One of Indonesia’s biggest labor groups, the Confederation of Indonesian Trade Unions (KSPI), intends to hold a massive protest against the omnibus bill on job creation following the House of Representatives’ decision to start its deliberation during the coronavirus pandemic.