Appeals court says hearings not needed over antibiotics in feed
New York's Second Circuit Court of Appeals ruled yesterday that the US Food and Drug Administration (FDA) is not required to hold public hearings on the safety of feeding antibiotics at subtherapeutic levels to food animals, a decision that advocates called a blow to public health, Food Safety News (FSN) reported today.
The two-to-one ruling overturns two district court decisions in 2012 in a casefiled in 2011 by the Natural Resources Defense Council (NRDC), the Center for Science in the Public Interest, Food Animal Concerns Trust, Public Citizen, and the Union of Concerned Scientists.
The groups say the FDA must hold hearings as a requirement for industry to prove that the use of penicillin and tetracyclines in animal feed is safe. The hearings would determine whether to withdraw approval of the drugs after the FDA said in 1977 that their use in animal feed has not been shown safe.
"The science was there in 1977 and 40 years later, it's only gotten stronger that these low-dose, routine use of antibiotics on livestock is causing development of antibiotic-resistant bacteria and that bacteria is coming off the farm in many different ways and affecting humans," said Mae Wu, an NRDC attorney.
NRDC says that not requiring hearings means the FDA doesn't have to consider banning the practice of feeding antibiotics to healthy animals, according to the FSN story.
"Today's decision allows the FDA to openly declare that a particular animal drug is unsafe, but then refuse to withdraw approval of that drug," wrote Judge Robert Katzmann in his dissent. "It also gives the agency discretion to effectively ignore a public petition asking it to withdraw approval from an unsafe drug."
The decision was a "big blow to public health," said Keeve Nachman, a scientist at the Johns Hopkins Center for a Livable Future. "I would expect that NRDC would appeal this decision in some manner."
Jul 25 FSN story
FDA, Mexican officials sign produce safety agreement
FDA officials traveled to Mexico this week to meet with their food safety counterparts, which resulted in the signing of a statement of intent to partner on the safety of fresh produce, the FDA said in a news release yesterday.
The group included FDA Commissioner Margaret Hamburg, MD, and other FDA officials. Mexican partners who signed the agreement were from the National Service for Agro-Alimentary Public Health, Safety and Quality (SENASICA) and the Federal Commission for the Protection from Sanitary Risks (COFEPRIS).
Hamburg said in the statement that regulatory success depends on developing new strategies and partnerships to better respond to challenges that come with globalization. "The FDA is working with our Mexican government counterparts as well as stakeholders from industry, commerce, agriculture, and academia to ensure the safety of products for American and Mexican consumers."
The FDA said Mexico is the leading exporter of FDA-regulated food that enters the United States. It added that the new partnership will focus on exchanging information to better understand each country's produce safety systems, developing outreach materials, identifying common approaches for training auditors, and increasing collaboration on trace-back activities.
Jul 24 FDA news release
One expert: Bioterrorism might explain some MERS mysteries
The multiple "paradoxes" in the epidemiology of MERS-CoV suggest that bioterrorism may be a factor, Australian epidemiologist Raina MacIntyre, MB BS, PhD, argues in an article today in Environment Systems and Decisions. But a Canadian expert called the suggestion unlikely.
MacIntyre, head of the University of New South Wales' School of Public Health and Community Medicine (SPHCM), says that many features of MERS-CoV (Middle East respiratory syndrome coronavirus) can't be explained by known principles of epidemiology.
For example, MERS-CoV has lower transmissibility than SARS (severe acute respiratory syndrome), yet it has persisted in humans far longer than SARS did, which suggests ongoing introductions of the virus.
She cites several other paradoxes:
- A hospital outbreak in Al-Ahsa, Saudi Arabia, had a classic epidemic pattern with some human-to-human transmission, but three different MERS-CoV strains were identified.
- The virus was present in Saudi Arabia during several mass gatherings, including the Hajj, but no epidemic occurred.
- The surge of MERS cases in Saudi Arabia in April and May of this year did not lead to epidemics in any other countries.
- Camels are suspected as a source of human cases, but many case-patients had no history of contact with animals or other MERS patients.
A large proportion of undetected (asymptomatic or mild) human cases might explain these puzzles, but this possibility is not supported by surveillance so far, MacIntyre writes.
"A careful review of the paradoxes and inconsistencies in the epidemiology of MERS-CoV raises deliberate release as possible explanation," she states.
But Allison McGeer, MD, a microbiologist and infection control expert at Mount Sinai Hospital in Toronto, said the hypothesis seems unlikely.
"I didn't have time to read the article really carefully, but what I seem to understand is that she is arguing that because it's sporadic there's a possibility it is deliberate, and I guess that's true," McGeer told CIDRAP News.
"But it really just seems more likely that it's sporadic and we don't understand the source, and you could say that of any disease that has multiple introductions from an unknown source. They could all be deliberate, but generally they're not."
She said she has not heard anyone previously suggest seriously that MERS-CoV involves bioterrorism. "It seems to me that there's not enough science behind it to make it really worth having a discussion about," she commented.
Jul 25 Environ Sys Decisions article
Jul 25 SPHCM press release
Observance puts focus on regions' hepatitis burdens
In the lead-up to World Hepatitis Day on Jul 28, two groups today highlighted the burden of the disease on their populations: the European Centre for Disease Prevention and Control (ECDC) and the World Health Organization (WHO) Western Pacific regional office.
The ECDC report notes that hepatitis C carries twice the disease burden of hepatitis B in Europe. From 2006 through 2012, European countries reported 206,000 hepatitis C cases, compared with 110,000 for hepatitis B. Also, though vaccination programs have led to the decline of acute hepatitis B infections, the number of chronic cases doubled in those years, the ECDC said.
Marc Sprenger, MD, PhD, director of the ECDC, said in an ECDC press releae that the numbers likely underestimate the burden of disease, due to underreporting and because some acute cases are asymptomatic. "This means that the problem is more serious than we thought and we need to strengthen existing prevention and control programs to reverse these trends," he said.
Meanwhile, the WHO said that countries in the Western Pacific region have a disproportionately high burden of hepatitis B infections. Though the area is home to about a quarter of the global population, it accounts for half the world's chronic cases. Levels of hepatitis C disease are also high in the region, the group added. Chronic hepatitis B is considered endemic in the region.
Shin Young-soo, MD, DrPH, regional office director, said in a statement that 30 of 37 countries have reached their 2012 milestones of reducing chronic hepatitis B infections among 5-year-old children to less than 2%. He said, though, that the region can do better by redoubling efforts to treat those who are already infected.
Jun 25 ECDC press release
Jun 25 WHO statement
WHO World Hepatitis Day background
