Daily safe intake limit for lean meat powder questioned, consumer concerns rise
Text by the Consumers' Foundation
At around 11 p.m. on March 5, the Executive Yuan launched a surprise announcement that it would conditionally lift the ban on leanness-enhancing drugs, and put forward a 16-character policy direction: "safe tolerance, separation of beef and pork, mandatory labeling, exclusion of offal." On April 11, the Food and Drug Administration of the Department of Health convened a "Food Sanitation and Safety Risk Assessment Meeting," planning to resolve and establish an ADI (Acceptable Daily Intake) assessment report, and recommended an ADI value for the animal feed additive ractopamine of 1 microgram per kilogram of body weight per day.
The Department of Health claimed that this ADI value of 1 microgram per kilogram of body weight per day had already taken into account individual differences among population groups, including infants under 18 months whose glucuronidation metabolic function is not yet mature, children and adolescents over 18 months, people with poor liver and kidney function, genetic polymorphisms of beta receptors, and sensitive groups such as patients with cardiovascular disease.
The Consumers' Foundation pointed out that the Food and Drug Administration of the Department of Health invited 16 experts and scholars to conduct an assessment of the acceptable daily intake (ADI value) of ractopamine hydrochloride (hereafter referred to as ractopamine) for humans, as the basis for our country's health risk assessment of ractopamine residues in food.
However, the Consumers' Foundation pointed out that the representativeness of the committee members participating in that meeting was insufficient, as it failed to broadly include experts from all sides, so whether such deliberations and considerations were adequate is questionable; moreover, the content of the safety assessment is likely to be disputed, and even the format and invited participants of the "Eating with Peace of Mind Briefing Sessions" currently being held nationwide by the Department of Health are suspected of amounting to endorsement.
Therefore, at the press conference held today (the 22nd) by the Consumers' Foundation, numerous scholars, including Professor Chen Shun-sheng, honorary vice superintendent of Kaohsiung Chang Gung Memorial Hospital; Dr. Tseng Kuei-hai, former president of the Southern Society; Dr. Chou Chin-cheng, superintendent and representative to the third expert meeting on US beef; Dr. Su Wei-shuo; Dr. Hsu Li-min; Chen Man-li, chairwoman of the Homemakers United Foundation; and Su Chin-hsia, chairwoman of the Consumers' Foundation, Chang Chih-kang, vice chairman, and Huang Yu-sheng, publisher, along with other board members, once again set out the problems with the content of the ADI, and called on all legislators to be sure to hold the line on the Food Sanitation Law amendment bills next Monday and next Wednesday, and not to plunge national health into a flawed process.
The Consumers' Foundation specifically calls for:
1. Domestically, ractopamine is still a banned drug, and discussing an ADI value violates procedural justice!
2. Without a ractopamine "health safety risk assessment" report that the public can trust and that is scientifically substantiated, no acceptable daily intake (ADI value) for ractopamine in humans can be established.
3. As long as the safety questions about ractopamine remain unresolved, the "not detectable" standard should be maintained in order to protect national health.
4. Consumers should exert consumer power by stopping eating questionable meat, writing to businesses and the government to express their views, demanding clear labeling, demanding a halt to sales, and even launching a boycott, in order to defend their own consumer rights!
Human trial data is incomplete, and was actually provided by the producer Eli Lilly
Superintendent Chou Chin-cheng pointed out that regarding ractopamine's pharmacological effects, toxicological responses, dosages and reactions when administered to animals (monkeys, dogs, etc., and the NOEL no-observed-effect level), and information on countries that permit the use of leanness-enhancing drugs, no detailed report or supporting literature was provided; in the dose-response assessment section, the Food and Drug Administration of the Department of Health did indeed put in some effort to understand a series of animal toxicology tests, including single-dose oral toxicity tests, in vitro and in vivo genotoxicity tests, repeated-dose toxicity tests with daily continuous oral administration for up to one year in multiple laboratory animal species, two-generation reproductive toxicity tests, and carcinogenicity studies, but the literature most relevant to the cardiovascular reactions that the public cares about most, namely special toxicology tests, was still not seen.
Professor Chou pointed out that in the human trial section, there was one clinical trial jointly designed by the US Food and Drug Administration and the manufacturer Elanco (Eli Lilly Asia) involving six healthy subjects; there was another clinical trial involving eight heart failure patients, lacking documentary scientific proof.
After in-depth research, Dr. Hsu Li-min of National Taiwan University Hospital found that the clinical trial involving 8 heart failure patients was truly absurd; he found the full text of that study in the medical library, and it was a study from 32 years ago, and it was actually done by Eli Lilly, when the aim was to develop another cardiotonic drug, which ultimately failed; later, Eli Lilly used it to calculate the ADI. What Dr. Hsu could not understand was that even just the unit conversion was astonishing, let alone the logical reasonableness; therefore, in the matter of leanness-enhanced US beef, the pressure exerted by the Eli Lilly pharmaceutical company on the US government, and by the US government on our country, is really much greater than imagined!
Dr. Su Wei-shuo questioned: food safety cannot use only "acute toxicity" as the sole risk assessment standard; chronic poisoning is the serious problem that requires even more painstaking research; moreover, research on ractopamine's organ toxicity should include cardiac muscle toxicity, skeletal muscle toxicity, teratogenic toxicity, reproductive toxicity and genotoxicity, as well as neurobehavioral toxicity, and none of these related studies were incorporated into this risk assessment, which clearly already violates the guidelines of international organizations on risk assessment.
In addition, Dr. Su pointed out that the assessment failed to include an important risk group, "fetuses," which is also objectionable; because ractopamine has teratogenic effects, and this had already been raised in the report, yet no assessment was made according to international principles for extrapolating animal teratogenic effects to humans, nor was the teratogenic risk that Taiwan would bear after liberalization calculated, nor the feasibility of risk management; these two points alone are enough to show that this is a "report" with major methodological flaws.
Therefore, Professor Chen Shun-sheng, honorary vice superintendent of Chang Gung Memorial Hospital and a physician in neurology, psychiatry and occupational medicine, emphasized that no matter what dosage is used in humans without passing human trials, not only are the side effects at one ten-thousandth, one thousandth or one hundredth unknown, even one tenth of the safety cannot pass. The controllability and unpredictability of animals' intake of feed containing ractopamine increase the need for meat inspection and the complexity of management.
Professor Chen pointed out that, based on his experiments on beta receptors in animals and humans and a literature review, he infers that the effects of ractopamine in human tissues on the cardiovascular, brain and reproductive systems await further confirmation of their safety, especially for those with hypertension, diabetes, cardiovascular disease, stroke, and maternal and child groups; its risk management should not stop merely at the level of purchase notification; manufacturers have an obligation to provide proof of human safety, and the government should hold the line on empirical evidence with the rigorous attitude befitting human research law.
In summary of the deficiencies and doubts found above, Professor Chen Shun-sheng strongly urged that when the Food and Drug Administration of the Department of Health cannot provide scientific evidence published domestically in foreign journals and is forced to cite foreign literature, it should bring out each original report for verification, explanation and empirical standards; otherwise, the cited literature is a "food sanitation and safety risk assessment meeting and assessment report" riddled with flaws, and simply cannot win the public's trust! As for why in the past US meat containing ractopamine was illegally allowed to be imported into Taiwan, the responsibility of the central competent authority should also be reviewed and pursued.
The Department of Health did not fully resolve the many doubts about ractopamine
In fact, the qualifications and backgrounds of the participating committee members are also open to discussion and public scrutiny! The Consumers' Foundation pointed out that when the European Union handles scientific affairs, it must uphold a purely scientific spirit of inquiry and hold a series of hearings and public hearings, and the participants must be there on the basis of professionalism and background, and cannot represent any specific group; members of EU scientific panels are even required to sign a "conflict-of-interest declaration," and members participating in scientific panels must, for each topic, also complete a declaration stating that they have no financial or interest relationship with the relevant industry, otherwise they may not participate in meetings related to the topic or write research reports.
Therefore, when the Department of Health convened this health safety risk assessment meeting concerning the safety and health of all citizens, did all the committee members, after such thinking and background understanding, appoint suitable committee representatives?! The Consumers' Foundation stated that because it received the meeting materials relatively late, it did not have sufficient time to carry out the relevant understanding, and it called on all legislators to ask the government to collect and compare all commissioned research and project materials from public departments such as Academia Sinica, the National Science Council, and the National Health Research Institutes, as well as from industry and other units, in order to prove the credibility of the committee representatives, and only then can the legality and credibility of this assessment meeting be proven!
Recently, Professor Donald M. Broom, former chairman of the EU Scientific Committee on Animal Welfare and a professor at the University of Cambridge in the United Kingdom, was invited by the College of Veterinary Medicine of National Taiwan University to participate in a seminar on animal welfare, and was therefore also invited to the Legislative Yuan on March 29 to deliver a special report on "The Impact of Ractopamine on Animals and Humans"; this material can once again be provided to relevant government units and the public for reference. (The "Scientific Panel on Animal Health and Welfare" in which Professor Broom participated is precisely an important mechanism for providing consultation to the European Parliament on meat safety and animal welfare.)
In his speech, Professor Broom cited a 2009 report by the European Food Safety Authority (EFSA) pointing out that ractopamine causes animals to suffer unnecessary pain during growth, not only infringing on animal welfare but also possibly being harmful to humans.
Broom pointed out that the EU prohibits the use of any hormones and thyroid-regulating beta-agonists in agriculture and animal husbandry, and ractopamine is one of them. According to the EFSA report, beta-agonists have anabolic effects, stimulate the adrenal glands, and promote animal growth and increase output; industry operators believe that feeding such leanness-enhancing drugs to animals will promote increased animal growth and output.
He cited EU research reports in pointing out that experiments were conducted on monkeys, dogs and pigs because ractopamine's effects on these organisms are the same as when used in humans, and the effects after ingestion include accelerated heartbeat and cardiovascular problems. He said that animals that consume ractopamine exhibit highly aggressive behavior.
Broom said that when animals eat feed with added leanness-enhancing drugs, besides increasing the water content of the meat, it can also increase or decrease fat content, but generally "does not change the protein in the meat"; however, protein, water and fat have a certain proportional relationship in the animal body, and adding leanness-enhancing drugs mainly increases the water content of the meat, so "what consumers buy is meat with a higher water content," and the price paid and the quality of the meat obtained will not conform to the principle of proportionality.
Broom stated that the research report also pointed out that zero detection should not be limited to meat only, but should also target zero detection of the metabolites of animals that have consumed ractopamine. In addition, another scientific panel proposed that consideration be given to the phenomenon that ractopamine may cause discomfort in humans, though the degree of discomfort caused cannot yet be quantified.
Furthermore, according to the conclusions of EFSA's research, although ractopamine is not carcinogenic and is not mutagenic, looking at that agency's 2009 ractopamine safety assessment, the expert committee's review of the relevant reports found that ractopamine showed a negative response in gene mutation tests on prokaryotes, but showed a positive response in some cell line tests; Broom believes: "there is indeed some genotoxicity."
Superintendent Chou Chin-cheng pointed out that research to date shows ractopamine is not carcinogenic, and only shows a weak genotoxic response in in vitro tests on some cell lines; however, beta-agonists have many kinds of chemical structures, and more research evidence is needed before a consistent view can be reached.
Furthermore, Broom pointed out that a 2-3 year study at Purdue University in the United States on the effects of ractopamine on pigs showed that after pigs consumed ractopamine, they "showed a great many negative effects," including, besides accelerated heartbeat, changes in the prefrontal cortex of the brain, increased aggression, and strongly aggressive behavior of chasing and biting their pen mates; and the researchers found that these changes were not only short-term, as such changes could still be seen after several weeks of consumption. Broom said the same situation also appears in cattle, which are more easily startled and show more restless behavior during transport, and cattle that have ingested ractopamine have a higher probability of developing hoof disease.
Broom emphasized that the conclusion he drew from various scientific reports is that the use of ractopamine benefits only producers, and does not benefit consumers.
However, consumer power in EU countries is even stronger: once a product raises safety concerns, the supermarket and retailer systems in the sales channels simply will not let problematic products go on the market, and consumers simply will not buy them. When consumers become aware of any concerns about safety, sanitation and other issues, such as possible problems with US beef, they will stop eating the meat, write to businesses and the government to express their views, demand clear labeling, demand a halt to sales, and even launch boycotts!
Therefore, the reason the EU can forcefully resist abnormal political and economic pressure is, in fact, the voice and power of the people!
In summary, the Consumers' Foundation calls for:
1. Domestically, ractopamine is still a banned drug, and discussing an ADI value violates procedural justice!
2. Without a ractopamine "health safety risk assessment" report that the public can trust and that is scientifically substantiated, no acceptable daily intake (ADI value) for ractopamine in humans can be established.
3. As long as the safety questions about ractopamine remain unresolved, the "not detectable" standard should be maintained in order to protect national health.
4. Consumers should exert consumer power by stopping eating questionable meat, writing to businesses and the government to express their views, demanding clear labeling, demanding a halt to sales, and even launching a boycott, in order to defend their own consumer rights!
Consumers' Foundation, Republic of China.