Lab animal standards are step toward Chinese national animal welfare act
BEIJING, China––A brief public comment period on draft animal welfare and ethics standards for Chinese laboratories closed on March 20, 2016.
The draft standards were released soon after two furors erupted over the use of lab animals in China.
Medical university dog use
“In one recent case,” summarized Wang Xiaodong for the state newspaper China Daily, “Xi’an Medical University in Shaanxi province suspended surgeries on animals in December after it was found that some dogs had been abused and their carcasses mishandled during research. An anonymous microblog that posted photos of more than 10 dogs bleeding on the roof of a university building went viral, drawing criticism and concern.”
Elaborated Humane Society International consultant Peter J. Li, “The provincial Bureau of Science & Technology issued two orders against cruel use of animals in research and suspended Xi’an Medical College’s animal research programs. China’s national TV station and media across country covered the brutality and public outcry,” including demonstrations led by the Xi’an Small Animal Protection Association, Xi’an Red Pomegranate Animal Protection Association, and China Animal Protection Power.
“XSAPA members met with the college administrators and rescued the remaining dogs,” Li added.
Breeding genetically modified autistic monkeys
The second furor broke out about six weeks later, after autism researchers Zilong Qiu and Sun Qiang at the Institute of Neuroscience in Shanghai reported in the journal Nature that they had inserted into macaques multiple copies of the MECP2 gene, believed to be linked to autism in humans.
Recounted Canadian bioethicist George Dvorsky, “The researchers modified 53 macaque embryos and implanted them into 18 surrogate mothers. This produced eight live births––three male, five female––and four stillbirths. All the resulting monkeys were shown to carry the human MECP2 transgenes. The transgenic monkeys developed normally at first, but symptoms [of autism] began appearing soon after they were one year old.”
This was initially acclaimed as a major breakthrough in developing an animal model for human autism, but soon raised international ethical concern as well.
Scaring the monkeys
“What’s concerning about this particular study,” wrote Dvorsky for Gizmodo.com, “is that the researchers assessed anxiety levels by frightening the monkeys in various ways, and then monitoring the intensity of their shrieks and screams.”
Chinese biomedical researchers themselves have long openly expressed ethical qualms about animal studies. In 2004, for example, a monument placed in front of the Wuhan University animal research center, in Hubai state, China, was dedicated “To lab animals who have died for the health of humans,” and “In special memory of the 38 rhesus macaques whose lives were devoted to Severe Acute Respiratory Syndrome research,” during a crash program responding to the deaths of more than 800 people.
Both inscriptions were authored by vaccine researcher Sun Lihua, the Xinhua News Agency reported.
New standard due by 2017
Against that backdrop, “China is expected to adopt its first national standard on laboratory animal welfare and ethics by the end of the year,” reported Wang Xiaodong for the state newspaper China Daily. “This will mark a major legislative breakthrough for the protection of animals used in research and testing by the pharmaceutical and other industries.”
The adoption of Chinese laboratory animal welfare standards is also widely expected to be preliminary to the eventual passage of a Chinese national animal welfare act, under discussion for at least decade. A draft Chinese animal welfare act prepared by a committee of scholars and representatives of animal welfare organizations was released for discussion in July 2009, but has not advanced.
In keeping with Confucian principles of government by winning compliance before seeking enforcement, the Chinese central government is believed to be encouraging major animal use industries to collaborate in producing welfare standards.
Only after most entities in each industry voluntarily observe animal welfare standards would the central government introduce a law to make observance compulsory.
The laboratory animal welfare standards are the first to emerge from the long consultative process.
Currently, said Sun Deming, who chairs the Welfare & Ethics Committee of the Chinese Association for Laboratory Animal Sciences, “Although all users of laboratory animals are required to conduct welfare and ethics reviews, they adopt different standards, and some are too lax.”
Borrowed from British
Sun Deming introduced the new draft standards during a recent two-day Sino-British Third International Seminar on Laboratory Animal Welfare and Ethics, held in Hefei, Anhui province, which was co-hosted by the association and the British government.
“We drew on experiences and lessons in the legislation of laboratory animal welfare from other countries, such as the U.K., when drafting the standard,” Sun Deming told China Daily. said. “If enacted, it will be of epoch-making significance for China’s laboratory animal welfare and ethics.”
Summarized Wang Xiaodong, “The draft includes requirements for the production, transportation and use of laboratory animals, including qualifications for personnel, animal-raising facilities, and the use of animals in testing.”
20 million animals per year
Yue Bingfei, director of the Laboratory Animal Monitoring Center at the National Institutes for Food and Drug Control, told China Daily that Chinese labs use about 20 million animals per year, mostly mice.
By comparison, European Union member nations use about 11.5 million animals per year, about four million of them used by the six largest university laboratories in the U.K.
The U.S. federal Animal Welfare Act does not require laboratories to publish the numbers of rats, mice, and birds they use.
Product safety testing
Lin Qingbin, an engineer at the Drug and Cosmetics Registration Management Department at the China Food & Drug Administration, mentioned to China Daily that his agency ceased requiring that cosmetics, shampoos, and perfumes be tested on animals effective on January 1, 2014.
Instead of having to submit products to CFDA laboratories for testing, Chinese manufacturers are now allowed to submit the product safety data compiled to demonstrate the safety of raw ingredients, which may include data from past animal testing.
Alternatively, the manufacturers may submit the data from non-animal safety testing methods accepted by the 27-nation European Union.
The amended testing rule currently applies only to products made within China, but may later be extended to imported products.
European Union, India, U.S.
The European Union completed a 15-year phase-out of animal testing requirements for cosmetics and cosmetic ingredients in March 2013. India banned animal testing of domestically produced cosmetics in June 2013. That left the U.S., Japan, and China as the last major markets for cosmetics and personal care produces that continued to require animal testing.
The 1.3 billion Chinese people, nearly 20% of the world’s population, spent $28 billion on personal care and cosmetic products in 2012, about a fifth of the global total.
India has 1.1 billion people, but the Indian market for cosmetics and personal care products, though growing at 13% per year in the present decade, is worth barely $8 billion a year.