UPDATED 12:28 a.m. EDT Nov. 27 — Government and industry officials say new labels for romaine lettuce will help keep the public safe during events such as the current E. coli outbreak. But, most entities in the supply chain are not involved in the initiative and not all forms of romaine will carry the voluntary labels for consumers.

Growers are working on their new labels now and will begin shipping romaine as soon as they start using them, according to announcements Nov. 26 from produce industry groups and the Food and Drug Administration. The FDA announcement also reported the agency has determined the current outbreak is linked to romaine only from specific areas of California.

A week ago, both the FDA and the Centers for Disease Control and Prevention warned against all romaine in all forms from all growing regions. That warning is now narrowed to romaine only from “the Central Coast growing regions of central and northern California.”  

“Growing and harvesting of romaine lettuce is now shifting to the winter growing regions of the U.S., which include mainly the California desert region of the Imperial Valley, the desert region of Arizona in and around Yuma, and Florida,” according to a statement from FDA Commissioner Scott Gottlieb.

Gottlieb said the public should continue to exercise extreme caution when it comes to romaine lettuce because of the ongoing outbreak. That advice is repeated in the revised public warning.

“Based on discussions with major producers and distributors, romaine lettuce entering the market will now be labeled with a harvest location and a harvest date,” according to the FDA. “Romaine lettuce entering the market can also be labeled as being hydroponically or greenhouse grown.

“If it does not have this information, you should not eat or use it.

“If consumers, retailers, and food service facilities are unable to identify that romaine lettuce products are not affected — which means determining that the products were grown outside the California regions that appear to be implicated in the current outbreak investigation — we urge that these products not be purchased, or if purchased, be discarded or returned to the place of purchase.”

Although some romaine is grown in Mexico and exported to the U.S. during the winter months, it is not implicated in the current outbreak, according to the FDA. Similarly, hydroponic romaine lettuce and romaine grown in greenhouses are also marketed in the U.S., but there is no information to suggest they are implicated in the three E. coli O157: H7 outbreaks identified since November 2017. 

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New outbreak numbers
The patient count in the current outbreak, which involves cases in the United States and Canada, is increasing. The CDC reports 43 U.S. residents across a dozen states have been confirmed with the outbreak strain of E. coli O157: H7. Canadian officials say 22 people in their country are sick from the same strain. No deaths have been confirmed in either country. 

In the United States, the outbreak reaches from coast to coast, with California hardest hit at 11 confirmed patients. New Jersey has the second most cases, reporting nine confirmed victims.

The E. coli O157: H7 isolated from patients in the current outbreak is the same strain that hit the U.S. and Canada a year ago. The late 2017 outbreak was linked to romaine and leafy greens. However, public health officials say it isn’t the same as the strain that sickened hundreds and killed five people earlier this year.

An overwhelming number of people in the current outbreak who have been interviewed so far by U.S. public health officials reported eating romaine lettuce in the days before becoming ill. The CDC’s update posted Nov. 26 said 88 percent of the people for whom the information was available said they ate romaine lettuce before their symptoms began.

The outbreak strain is also proving particularly dangerous, based on the hospitalization rate. Of the patients for whom the information is available, 42 percent have been admitted to hospitals. One person in the United States has developed hemolytic uremic syndrome (HUS) a potentially deadly form of kidney failure. The U.S. victims range in age from 1 to 84 years old.

Illnesses in the United States began on Oct. 8, with the most recent onset date reported as of Oct. 31. However, it can take several weeks for the CDC to receive reports of confirmed cases because of the time required for laboratory tests and the notification process. Consequently, illnesses that began before Oct. 31 may not yet be included in the CDC’s count.

Voluntary labeling plan
A number of produce industry groups have been working with government officials to develop labels to make traceback investigations easier and faster. The United Fresh Produce Association in Washington, D.C., sent an alert to members Nov. 26 with details about the new labeling plan, as did the Florida Fruit and Vegetable Association.

“The revised consumer advisory is welcome news for Florida growers,” Lisa Lochridge, director of public affairs for the Florida Association, told Food Safety News. “We are working with our state department of agriculture on the new labels.

“We began harvest around Nov. 8, so it’s clear that Florida romaine couldn’t have been part of this outbreak.”

Lochridge said there are about 4,500 acres of romaine in Southern Florida. That’s a small fraction of the acreage in California and Arizona, but it’s still a $95 million industry on an annual basis.

Jennifer McEntire, United Fresh vice president of food safety and technology, agreed that the FDA’s revised public warning is good news for the industry.

“Romaine that will soon be available in grocery stores and restaurants could not have been related to the outbreak. This labeling will give consumers assurance that they can purchase romaine again,” McEntire said in a statement issued immediately after the FDA announcement.

United Fresh created a question-answer document about the process and purpose of developing the new traceability labels. (Click here to read the entire document.)

Scott Horsfall, executive director for the California Leafy Greens Marketing Agreement (LGMA) organization, said West Coast growers are pleased that the romaine market will be open again. 

“This episode drives home how important traceability labeling is,” Horsfall told Food Safety News. “The information has always been captured for traceback, but it wasn’t part of the consumer-facing package.”

Government asked for, and industry agreed to, a voluntary market withdrawal and a shipping moratorium for all romaine on Tuesday before Thanksgiving. In his statement Nov. 26, Commissioner Gottlieb said the action was necessary to protect the public. 

Scott Gottlieb

“The FDA believes it was critically important to have a ‘clean break’ in the romaine supply available to consumers in the U.S. in order to purge the market of potentially contaminated romaine lettuce related to the current outbreak. This appears to have been accomplished through the market withdrawal request of Nov. 20,” Gottlieb said.

The LGMA in California and its sister LGMA in Arizona already require grower members to be able to trace their products back to the specific field where they were grown, but those traceability details stop at the edge of the field. Processors, packers, shippers, distributors, retailers, and restaurants have not been part of the LGMA traceability efforts. Neither are those supply chain entities involved in the voluntary labeling plan announced Nov. 26.

Produce group representatives say the voluntary “origin/harvest date” labels on “bagged” romaine products should be on the consumer-level packaging in a prominent place and presented in a form that consumers will understand. The recommended form is: “Romaine grown in (source) and harvested after (date).” 

However, if consumers are not buying bagged salad products, but rather opting for whole head or hearts of romaine, they probably won’t be seeing traceback information. So-called “commodity products” are most often packed in boxes without individual packaging. For commodity romaine, the traceback labels are expected to be used at the carton level.

“For the time being, retailers may elect to provide signage to consumers regarding the growing region origin of commodity romaine — as indicated on cases containing romaine — following the way that country of origin labeling is communicated,” according to the Q&A document posted by United Fresh. “As this new approach is taken, we will continue to optimize recommendations to improve clarity and feasibility. 

“Foodservice operations (including restaurants) should expect to field consumer questions regarding the source of romaine lettuce.”

United Fresh staff has been working with the Produce Marketing Association (PMA), and regional groups on the labeling initiative. Those other groups include Western Growers, California LGMA, Arizona LGMA, Grower-Shipper Association of Central California, Florida Fruit and Vegetable Association, Yuma Fresh Vegetable Association, and Yuma Safe Produce Council.

The new labeling practices for growers are expected to be used from now and going forward, according to the FDA and produce groups. Gottlieb said he expects providing consumers with the traceability information will become standard practice.

“In addition, the leafy greens industry has agreed to establish a task force to find solutions for long-term labeling of romaine lettuce and other leafy greens for helping to identify products and to put in place standards for traceability of product,” Gottlieb said.

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