Industry group updates standards for responsible antibiotic manufacturing

News brief

The AMR Industry Alliance announced this week that it has updated its Antibiotic Manufacturing Standard to be more aligned with World Health Organization (WHO) antibiotic manufacturing guidelines.

The Standard, developed in 2022 in collaboration with the British Standards Institute (BSI), provides guidance to antibiotic manufacturers to help ensure that their products are made responsibly and don't contribute to the development of antimicrobial resistance (AMR) in environmental bacteria. Among other things, it requires antibiotic manufacturers to have an effective environmental management and wastewater treatment system that minimizes antibiotic discharges in wastewater.

A certification scheme launched in 2023 provides third-party independent verification that the Standard is being met at antibiotic manufacturing sites. To date, more than 60 antibiotic products have been independently verified by the BSI AMR certification.

Update reflects latest science, best practices

The AMR Industry Alliance says the update version of the Standard reflect the latest science and best practices and incorporates provisions for waste management, active pharmaceutical ingredient discharge limits, and transparency in supplier practices laid out in the WHO's 2024 Guidance for Responsible and Sustainable Manufacturing of Antibiotics.

"We welcome the WHO's leadership in setting global expectations for responsible antibiotic production," Steve Brooks, chair of the Manufacturing Working Group at the AMR Industry Alliance, said in a press release.

The updated Standard will be incorporated into the BSI AMR certification starting in 2026.

About 1% of North Dakota deer sampled in 2024 hunting season had CWD

News brief

Mary Van Beusekom, MS

Mule deer in field — Mark Moschell / Flickr cc

A total of 1.2% of deer tested for chronic wasting disease during the 2024 North Dakota deer-hunting season were positive for the fatal neurologic disease, the North Dakota Game and Fish Department reports on its website.

Of the 1,456 mule deer and white-tailed deer tested, 17 had CWD, of which 15 were hunter-harvested, and 2 were ill deer confirmed through diagnostic examination. Fourteen of the cases were mule deer, and the remainder were white-tailed deer. All cases were from the western part of the state, including two from previously unaffected hunting units 3B2 and 3B3, both located in the western-central region.

Sampling efforts fell short of the 10% goal in units where CWD surveillance was concentrated.

"Sampling efforts fell short of the 10% goal in units where CWD surveillance was concentrated," the department noted.

During the 2023 season, 11 of 2,240 sampled deer (0.5%) had CWD. And in 2022, of 1,968 animals tested, 24 (1.2%) were positive.

Type of transmissible spongiform encephalopathy

CWD, which infects cervids such as deer, moose, and elk, is a type of transmissible spongiform encephalopathy. These illnesses are caused by prions, or infectious misfolded proteins. CWD spreads from animal to animal through direct contact or through environmental contamination. CWD prions can persist for years and withstand heat, radiation, and formaldehyde.

Although no human cases have been reported, health officials urge hunters to have their harvest tested before consumption, especially if it was taken in a CWD-endemic area.