Baby botulism outbreak: FDA still doesn’t know cause—or how to prevent it

婴儿肉毒杆菌中毒事件：FDA 仍未查明原因，也无法预防

The Food and Drug Administration this week posted what critics call an “underwhelming” epilogue to the devastating outbreak of botulism in babies, which was linked to spore-contaminated formula made by ByHeart. Despite clear tracking of the contamination, the regulator still doesn’t know how the bacteria arrived in the formula—or how to prevent it from happening again. 美国食品药品监督管理局（FDA）本周发布了一份被批评者称为“令人失望”的结案报告，针对的是此前由 ByHeart 公司生产的、受孢子污染的婴儿配方奶粉所引发的毁灭性肉毒杆菌中毒事件。尽管污染源的追踪路径清晰，但监管机构仍不清楚细菌是如何进入配方奶粉的，也无法说明如何防止此类事件再次发生。

“The FDA’s investigation into the root cause is ongoing with a focus on ingredients,” the agency reported. In the void, three companies at the center of the investigation are left pointing fingers at each other, with none publicly taking responsibility for the contamination. 该机构报告称：“FDA 对根本原因的调查仍在进行中，重点在于原材料。”在调查结果缺失的情况下，处于风暴中心的这三家公司互相推诿，没有一家公开为此次污染承担责任。

The outbreak was identified in early November and was declared over by the FDA and Centers for Disease Control and Prevention on February 26. In the end, 48 infants across 17 states were sickened and hospitalized. Some are still recovering months after the life-threatening infection. 此次疫情于去年 11 月初被发现，并于 2 月 26 日被 FDA 和美国疾病控制与预防中心（CDC）宣布结束。最终，全美 17 个州的 48 名婴儿因此患病并住院治疗。在经历过这场危及生命的感染数月后，一些婴儿仍在康复中。

The FDA’s investigation provided a detailed trace of the bacteria behind the outbreak, Clostridium botulinum, which can produce hardy spores that are found in soil and sediments. If the spores reach an amenable environment—such as the vulnerable, underdeveloped guts of infants—they begin to grow and produce a neurotoxin that causes flaccid paralysis. FDA 的调查详细追踪了此次疫情背后的元凶——肉毒杆菌（Clostridium botulinum），这种细菌能产生存在于土壤和沉积物中的顽强孢子。如果孢子进入适宜的环境（例如婴儿脆弱且发育未完全的肠道），它们就会开始生长并产生导致弛缓性麻痹的神经毒素。

Strains of C. botulinum isolated from some of the sick infants were genetically linked to strains found in ByHeart’s formula, which were also linked to strains found in powdered whole milk used in the formula. The powdered whole milk was dried from liquid milk at a Nevada facility run by Dairy Farmers of America, and the liquid milk came from the supplier Organic West, based in California. Organic West sold the resulting powder to ByHeart. 从部分患病婴儿体内分离出的肉毒杆菌菌株，在基因上与 ByHeart 配方奶粉中发现的菌株相吻合，而后者又与配方奶粉中所使用的全脂奶粉中的菌株相关联。这些全脂奶粉是由美国奶农协会（Dairy Farmers of America）在内华达州的一家工厂将液态奶干燥而成，而液态奶则来自位于加利福尼亚州的供应商 Organic West。Organic West 将生产出的奶粉出售给了 ByHeart。

Specifically, the FDA traced contaminated formula and milk powder back to eight whole milk lot powders that came from 33 fluid milk lots from Organic West, according to an incident summary. Still, the FDA could not determine where in the production chain the bacteria entered or how. “Even though there are several hypotheses, investigational findings could not identify the source or root cause of contamination of the powdered infant formula,” the agency concluded. 根据一份事故摘要，FDA 将受污染的配方奶粉和奶粉追溯到了 8 批全脂奶粉，这些奶粉源自 Organic West 提供的 33 批液态奶。尽管如此，FDA 仍无法确定细菌是在生产链的哪个环节进入的，也无法确定进入方式。该机构总结道：“尽管有几种假设，但调查结果无法确定婴儿配方奶粉污染的来源或根本原因。”

Finger-pointing

互相推诿

Bill Marler, a lawyer specializing in food poisoning who is also representing 25 of the sickened infants in litigation, told Ars that the conclusion is “a little underwhelming to put it mildly.” The epilogue that the FDA posted this week, titled the “Post-Outbreak Response Activities,” provided a summary “without any real clear guidance for consumers or for the companies going forward.” 专门处理食物中毒案件的律师比尔·马勒（Bill Marler）目前正代理 25 名患病婴儿的诉讼。他告诉 Ars 媒体，这个结论“往轻了说，确实有点令人失望”。FDA 本周发布的这份名为“疫情后响应活动”的结案报告，提供了一份总结，但“对于消费者或相关公司未来的行动，没有任何真正明确的指导”。

In the meantime, each of the three companies is shirking blame. ByHeart released a statement this week saying “FDA has shared that it did not identify any deficiencies in ByHeart’s facilities that could explain the root cause of this outbreak.” Bill Van Ryn, an owner of Organic West Milk, previously stressed in media reports that “nothing has been proven about our milk yet.” Likewise, Dairy Farmers of America blamed Organic West, saying its processing met all required tests. “Manufacturers of end-use consumer products have a responsibility to properly process ingredients to ensure product safety,” Dairy Farmers of America said in a statement. 与此同时，这三家公司都在推卸责任。ByHeart 本周发表声明称：“FDA 已告知，未在 ByHeart 的设施中发现任何可以解释此次疫情根本原因的缺陷。”Organic West Milk 的所有者比尔·范·莱恩（Bill Van Ryn）此前在媒体报道中强调：“我们的牛奶尚未被证实有任何问题。”同样，美国奶农协会将责任归咎于 Organic West，称其加工过程符合所有必要的测试要求。美国奶农协会在声明中表示：“终端消费品的制造商有责任妥善处理原材料，以确保产品安全。”

While Marler wants to see more investigation and action by the FDA to understand and prevent another outbreak from happening, the blame ultimately lies with ByHeart, he says. It’s “not only an ingredient problem that happened to pass through ByHeart. That is ByHeart’s product, in ByHeart’s can, with ByHeart’s name on it, fed to a baby,” he wrote in a recent blog post. “Sourcing, verifying, and testing what goes into infant formula is the job.” Marler also noted that this is not the first time infant botulism has been linked to infant formula. 虽然马勒希望看到 FDA 进行更多的调查和采取行动，以了解并防止再次发生疫情，但他认为责任最终在于 ByHeart。他在最近的一篇博客文章中写道：“这不仅仅是一个恰好经过 ByHeart 的原材料问题。这是 ByHeart 的产品，装在 ByHeart 的罐子里，印着 ByHeart 的名字，喂给了婴儿。采购、验证和测试婴儿配方奶粉的成分是他们的职责。”马勒还指出，这已经不是第一次发生婴儿肉毒杆菌中毒与婴儿配方奶粉相关联的事件了。

In its statement this week, ByHeart said it is working to resume infant formula production. The company is now working with a lab to develop more sensitive testing for C. botulinum in its products. ByHeart 在本周的声明中表示，公司正致力于恢复婴儿配方奶粉的生产。目前，该公司正与一家实验室合作，开发针对其产品中肉毒杆菌的更灵敏的检测方法。