The CDC Chipotle E. coli Spat and the Public’s Right to Know, Sometimes
Source : https://foodpoisoningbulletin.com/2016/the-cdc-chipotle-e-coli-spat-and-the-publics-right-to-know-sometimes/
By Carla Gillespie (May 8, 2016)
Chipotle’s beef with the CDC’s coverage of its 2015 E. coli outbreaks made headlines this week when letters exchanged between the two were made public. While the bandwagon touting the CDC as a champion of the public’s right to know got pretty crowded in the last couple of days, the bottom line is this: yes, the public does have a right to know, but usually it is never told.
By the CDC’s own admission, only a fraction of the outbreaks it investigates are made public. On average, it announces 10 multistate outbreaks a year. And it’s not really clear how the outbreaks on the CDC’s “list of selected outbreak investigations” are selected. Some have four case patients others have four hundred. Some occur in two states, others occur in more than 40 states. Some have information about the food source, some don’t. Some have the name of a restaurant involved, some say restaurants are involved but don’t name them and some provide only a description of the restaurant such as “Mexican-style fast food restaurant chain Restaurant Chain A” or “sandwich shop chain.” Some reports are published after the outbreak is over, some while it is ongoing.
Reports on some multistate outbreaks linked to restaurants are never made public by the CDC. A 2015 Salmonella outbreak linked to Fig & Olive restaurants sickened 175 people from six states. After the CDC took the lead on the investigation, it published nothing about the outbreak.
On March 16, 2016, one day after Food Poisoning Bulletin broke the story of a mulistate E. coli outbreak linked to Pizza Ranch restaurants that sickened 13 people in nine states between December 2015 and February 2016, the CDC released a statement saying only that the outbreak was over as the last reported case was February 9, 2016. Because it never issued a report, we don’t know when the CDC learned of the outbreak. We do know that two young children developed HUS, a life-threatening complication of E.coli infections and were hospitalized. And that the outbreak was linked to contaminated dough used to make dessert pizzas, not a typical vehicle for E.coli, so the CDC could have used that as a teaching moment. But it did not.
All of that is not to say that the folks at the CDC and the FDA aren’t working hard everyday to try to keep the public safe. Countless state and local public health officials are too. But there is a lot of food poisoning going on out there and the public has no idea about most of it.
So, what happened with Chipotle?
Letters exchanged between Chipotle and CDC in December 2015 were published online this week and Reuters reported on them. (You can read the letters here and here.) To be clear, the argument is not, as some have reported, that Chipotle did not want the the public to know about the outbreak. Instead, the company takes issue with the the language and timing of some of the agency’s reports.
“While the initial announcement and early updates were generally necessary and appropriate, the ongoing updates were not useful and did not serve to inform the public of a significant health risk. Rather, these updates misrepresented the E. coli O26 outbreak as ongoing and unnecessarily intensified the public’s concern,” the letter from Chipotle’s lawyers states.For example, the last illness was reported December 1, 2015, but the CDC issued three reports after that and did not issue a final report stating the outbreak was over until February 1, 2016. (See Pizza Ranch timing above.) And some of the people who were sickened by the outbreak strain of E. coli O26 did not eat at Chipotle, according to the CDC, yet their states are included in the outbreak reporting.
Genetic testing was used to identify 36 of the 55 cases in this outbreak and four of the cases reported in the second outbreak. The CDC says 47 of 52 patients interviewed reported eating at Chipotle before they became ill. That all 52 cases are attributed to the “Chipotle E. coli outbreak” even though not all did not say they ate Chipotle food is not different than the way the CDC has reported other outbreaks.
The exact number of people who ate food and got sick from it is important to every company involved in a food poisoning outbreak. Chipotle is not different than others on that score. But the biggest, most important question is not whether it was a nine-state outbreak or a seven-state outbreak; it’s what was the contaminated food source?
More than 2,500 tests were performed on Chipotle food, restaurant surfaces and equipment and none was positive for E.coli, according to the U.S. Food and Drug Administration (FDA). Yet no traceback investigation provided a clue?
What food distributors of affected Chipotle restaurants were involved? And did they also do business in the states where people were sickened by the same E. coli strain but did not eat at Chipotle?
The public has a right to know, but most often we aren’t told.
Alaska food safety, sanitation programs face possible budget cuts
Source : http://www.ktuu.com/content/news/Budget-cuts-take-a-bite-out-of-Alaskas-food-safety-division-378580816.html
By Associated Press (May 08, 2016)
JUNEAU, Alaska (AP) Alaska's food safety and sanitation inspection program could take another budget hit this year that many say could lead to more illnesses for Alaskans.
The latest round of budget cuts could leave residents vulnerable to dirty restaurant kitchens, foodborne illnesses and scummy pools as the 13 inspectors tasked with overseeing thousands of facilities statewide fall behind.
Among the programs on the chopping block are the state's public pool and spa inspections.
Food Safety and Sanitation program manager Kim Stryker says further cuts will mean losing more staff just as the division takes on more responsibility with the incoming marijuana industry. The division will oversee edibles and concentrate producers.
EU won't sacrifice food safety for US trade deal: Germany
Source : http://www.thelocal.de/20160507/eu-wont-sacrifice-food-safety-for-us-trade-deal-germany
By thelocal.de (May 07, 2016)
The EU won't sacrifice its high food safety standards for better US auto market access in a transatlantic trade deal being negotiated, a German minister said Friday.
The comments by Agriculture Minister Christian Schmidt were the latest criticism of the thorny negotiations toward sealing a wide-ranging pact that would create a free-trade zone covering 850 million people.
Washington and Brussels want the Transatlantic Trade and Investment Partnership (TTIP) completed this year before US President Barack Obama leaves office, but it has faced mounting opposition on both sides of the Atlantic.
Schmidt told the German news weekly Der Spiegel that it was time for the United States to "at last make a move" if it wants the agreement.
"So far at least they have hardly made any serious concessions," the minister was quoted as saying in an early excerpt of the interview in Saturday's edition of Der Spiegel magazine.
US policymakers are wrong if it thought "they can lure us Germans with concessions in the automotive sector", he said.
"We won't sacrifice our high food safety standards in a barter trade for approval of European car blinkers," he said, in reference to industry standards on car parts.
"One has nothing to do with the other," he said. "There won't be any such horse-trading."
Environmental group Greenpeace on Monday released a trove of leaked documents about the closed-door negotiations, claiming that a deal would inflict a dangerous lack of standards on US and European consumers.
To some observers, the draft text suggested that the US side is trying to use the carrot of easing restrictions on auto imports from Europe for concessions on its agricultural exports, perhaps including genetically modified foods.
Germans are growing increasingly wary of the proposed pact, an opinion poll showed Thursday.
Some 70 percent of Germans polled by the dimap institute for broadcaster ARD said it would bring "mostly disadvantages", up from 55 percent in a similar poll in June 2014.
Chancellor Angela Merkel, meanwhile, this week reiterated her government's official position, saying that she would "do everything to conclude the negotiations", preferably by the end of 2016.
But German Economy Minister Sigmar Gabriel, a Social Democrat, warned last month that negotiations on the free trade deal "will fail" if the US refuses to make concessions.
"The Americans want to hold fast to their 'Buy American' idea. We can't accept that," he said.
France has also hit out at the pact, with President Francois Hollande saying this week that Paris would reject it "at this stage" because his country opposes "unregulated free trade".
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Recall issued on undercooked Idaho Jerky distributed in Northwest
Source : http://www.foodsafetynews.com/2016/05/126118/#.Vy_xP07yWUl
By News Desk (May 7, 2016)
The 4 Frendz Meat Market, located in Clarkson, WA, issued a recall on Saturday for approximately 497 pounds of beef jerky products due to under-processing and potential survival of bacterial pathogens in the products.
The announcement was made by the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) on behalf of the company. The suspect jerky was produced from Aug. 10, 2015 to April 11, 2016. Products are subject to recall include:
• 3-oz. VACUUM-PACKED packages containing “SOUTHFORK SAUSAGE MESQUITE PEPPER JERKY.”
• 3-oz. VACUUM-PACKED packages containing “SOUTHFORK SAUSAGE HONEY JERKY.”
• 3-oz. VACUUM-PACKED packages containing “SOUTHFORK SAUSAGE MESQUITE JERKY.”
• 3-oz. VACUUM-PACKED packages containing “SOUTHFORK SAUSAGE TERIYAKI JERKY.”
• 3-oz. VACUUM-PACKED packages containing “SOUTHFORK SAUSAGE HOT HONEY JERKY.”
The recalled products bear establishment number “EST. M22017” inside the USDA mark of inspection. These jerky was shipped to retail locations in Idaho and Washington.
The under processing problem was discovered during a comprehensive FSIS Food Safety Assessment (FSA) inspection performed in the establishment by an FSIS Enforcement Investigations and Analysis Officer.
While the under processing may have extended back eight months, FSIS says it has no confirmed reports of any illnesses from anyone eating the jerky. Anyone concerned about an injury or illness should contact a healthcare provider.
FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution list(s) will be posted on the FSIS website.
Appoint Food Safety Officers Within Eight Weeks: High Court
Source : http://food.ndtv.com/food-drinks/appoint-food-safety-officers-within-eight-weeks-hc-tells-delhi-1403438
By food.ndtv.com (May 07, 2016)
The Delhi High Court has directed the city government to appoint, within eight weeks, food safety officers here, to keep a tab on use of pesticides in vegetables and fruits sold across the national capital. A division bench of Chief Justice G. Rohini and Justice Jayant Nath asked the government to file an affidavit indicating what steps they have taken on appointment of food safety officers.
Posting the matter for August 10, the court asked the government to take necessary steps for appointment of food safety officers in terms of Food Safety Standards Authority of India (FSSAI).
The court's direction came after amicus curiae Saket Sikri told it that there is scarcity of food safety officers in Delhi for collecting samples, and the Delhi government had also accepted that in its affidavit filed in November last year.
A report submitted by the amicus curiae had earlier said that in a number of vegetables and edible items, pesticide residue was found to be beyond permissible limits. A large quantity of vegetables and fruits sold in the capital contains dangerous pesticides that can cause serious health problems, the report had said. The high court had earlier taken suo motu cognizance of an NGO report that said the amount of pesticides used by farmers in India was as much as 750 times higher than European standards.
U.S. and Canada agree their food safety systems are comparable
Source : http://www.foodsafetynews.com/2016/05/u-s-and-canada-agree-their-food-safety-systems-are-comparable/#.Vy_xr07yWUl
By News Desk (May 6, 2016)
The United States and Canada have comparable food safety systems, a fact that has now been officially recognized by the U.S. Food and Drug Administration (FDA). The food safety systems for Australia and the European Union are likely coming soon.
The U.S. and New Zealand have had an agreement that their systems are comparable since 2012.
The Food Safety Systems Recognition Arrangement between the U.S. and Canada lays down a framework for regulatory cooperation between the neighboring counties that runs the gamut from scientific collaboration to outbreak response. The FDA, Public Health Agency of Canada and the Canadian Food Inspection Agency are all parties to the agreement.
FDA needs foreign help in implementing the historic Food Safety Modernization Act, which calls for imposing the same standards on foreign food as required of domestic sources.
The agreement sets up a U.S.-Canada Regulatory Cooperation Council to help the two countries “better align their food safety regulatory systems, reduce unnecessary duplication, enhance information sharing, and to the extent possible, leverage resources so that the agencies can better meet their public health objectives.”
The use of an agreement over comparable systems is pretty much the same way the U.S. Department of Agriculture (USDA) has gone about approving countries for importing meat into the U.S., and visa versa.
Government agreements, especially those that clear away overlap and duplication, are usually met with favor by producers and manufacturers.
“This recognition arrangement will significantly benefit both consumers and the produce industry by facilitating trade, reducing redundant regulatory requirements and enabling even greater confidence in the produce that is traded between our two countries,” said Jim Gorny, vice president for food safety and technology for the American-based Produce Marketing Association.
The complete text of the agreement is available on the FDA website.
New Food Safety Whistleblower Regulations: OSHA Bites Off More Than It Can Chew
Source : http://www.environmentalsafetyupdate.com/osha-compliance/new-food-safety-whistleblower-regulations-osha-bites-off-more-than-it-can-chew/?utm_source=Mondaq&utm_medium=syndication&utm_campaign=View-Original
By Mark A. Lies II and Adam R. Young (May 5, 2016)
Seyfarth Synopis: Employers may face liability for retaliation charges from employees who report food safety issues under the Food Safety Modernization Act (FSMA).
Employers in the food industry have a new headache to worry about. On April 18, 2016, the federal Occupational Safety and Health Administration released final rules establishing standards and procedures for whistleblower and retaliation complaints. Employees now may file whistleblower complaints with OSHA based on their reports of food safety concerns.?
The FSMA protects employees who provide information relating to any action that the employee reasonably believes to be in violation of the Federal Food, Drug, and Cosmetic Act.? The Act protects internal reports to management, even if made in the ordinary course of the employee's duties. If an employee works as a food safety professional, the employee's regular job duties (reporting food safety issues to the employer) are "protected activities."? Any adverse employment action against a food safety professional could result in a retaliation claim with OSHA, and subject the employer to an Agency investigation.
The FSMA further protects employees who testified or assisted in a proceeding about the violation, or refused to participate in any activity or assigned tasks reasonably believed to be in violation of the law.
Burdens of Proof
Under the regulations, an employee complainant need only present "direct or circumstantial evidence" to give rise to "an inference" that (1) the employer suspected that the employee engaged in protected activity, and (2) the protected activity was a "contributing factor" in the adverse action. Mere "temporal proximity" to the protected activity is sufficient to meet the complainant's burden.? OSHA will conduct an investigation, unless the employer can demonstrate by "clear and convincing evidence" that it would have taken the same adverse action in the absence of the protected activity.
After OSHA completes its investigation, the Agency will have to prove to an Administrative Law Judge by a preponderance of the evidence that protected activity was a contributing factor in the adverse action alleged in the complaint. An employer can avoid liability if it demonstrates by "clear and convincing evidence" that it would have taken the same adverse action in the absence of any protected activity.
Statute of Limitations
The rule provides a 180-day statute of limitations for retaliation claims, beginning when the employee is aware or reasonably should be aware of the employer's decision to take an adverse employment action.
Remedies and Settlement
The regulations provide for damages, reinstatement with back pay and interest, and litigation costs.? OSHA retains the right to review and reject any settlement agreement between the complainant and the employer.
Employers must be vigilant to promptly address food safety issues and prevent retaliation claims from employees. Employers should diligently record their rationales for adverse employment actions.? If an employer receives a retaliation claim, the employer should take immediate action; a position statement is due to the OSHA investigator within 20 days of receipt of notice.? To avoid an inspection, that position statement must meet a high bar of proof that no retaliation took place.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
FDA Recognizes Canada as Having a Comparable Food Safety System to the U.S.
Source : http://www.foodsafetymagazine.com/news/fda-recognizes-canada-as-having-a-comparable-food-safety-system-to-the-us/
By Staff (May 04, 2016)
The U.S. Food and Drug Administration (FDA) in conjunction with the Canadian Food Inspection Agency (CFIA) and the Department of Health Canada have all signed an arrangement acknowledging that each of the agencies’ food safety systems are comparable to one another. The arrangement was signed at a meeting of the FDA-CFIA Health Canada Joint Committee on Food Safety.
By recognizing each other’s systems, FDA, CFIA, and Health Canada have confidence that they can leverage each other’s science-based regulatory systems. For example, each partner will consider the oversight of the other when prioritizing inspection activities, but the benefits go beyond inspection and admissibility. Systems recognition establishes a framework for regulatory cooperation in a variety of areas that range from scientific collaboration to outbreak response.
Systems recognition involves reviewing a foreign country’s domestic food safety regulatory system to determine if it has legal authorities and regulatory tools that together provide public health outcomes comparable to those provided by the FDA. Domestic systems provide the baseline level of public health protection that helps assure the safety of exported foods from that country. Systems recognition will help the FDA be more risk-based in planning the scope and frequency of its inspection activities, including foreign facility inspections, import field exams, and import sampling.
The FDA, working with the CFIA and Health Canada, conducted a systems recognition review and assessment using the International Comparability Assessment Tool. The process includes a comprehensive review of key elements of the country’s national food safety control system such as its relevant laws and regulations, inspection programs, response to food-related illness and outbreaks, compliance and enforcement and laboratory support.
Systems recognition is voluntary and not required in order for a country to export foods to the U.S.
Canada is not the only foreign food safety system that the FDA has deemed comparable to itself. New Zealand’s food safety system earned the same acknowledgement in 2012. The FDA is currently working on similar agreements with Australia and the European Commission.
European food safety body to review BPA safety
Source : http://www.rsc.org/chemistryworld/2016/05/bpa-bisphenol-european-food-safety-body-review
By Emma Stoye (May 03, 2016)
The European Food Safety Authority (EFSA) has said it will conduct a review of the latest scientific evidence on the safety of bisphenol A (BPA) following a damning report from the Dutch National Institute for Public Health and the Environment (RIVM) that raised concerns over BPA’s effects on the immune systems of unborn children and infants.
The compound, which is used to make plastic food packaging, has been the subject of controversy in recent years. The EFSA’s stance until now has been that at current levels of consumption, the levels of BPA most people are exposed to are not a health hazard. But the RIVM report pointed to two studies that showed even low exposures can impair rats’ immune systems in the very early stages of life.
At the time the EFSA conducted its last review into BPA in 2014 these studies had not been published. That review resulted in the safe exposure limits being revised from 50 to 4µg per kilogram of body weight per day. The EFSA will consult on the latest BPA research next year and is expected to report its findings in 2018.
It’s Only Natural: Recent Developments Regarding the Term “Natural” in Food Labeling
Source : http://www.foodsafetymagazine.com/enewsletter/ite28099s-only-natural-recent-developments-regarding-the-term-e2809cnaturale2809d-in-food-labeling/
By Nilda M. Isidro, Esq. (May 03, 2016)
The question of which foods can be labeled as “natural” continues to be one of the most commonly litigated issues relating to food labeling. A recent Consumer Reports survey found that more than half of consumers seek out products with a “natural” food label, and that nearly half of consumers incorrectly believe that the use of the term “natural” is independently verified. Against this backdrop, it is only natural that the use of the term is being increasingly discussed by the U.S. Food and Drug Administration (FDA) and legislators. Although FDA has so far declined to resolve the issue, that may be changing in the relatively near future. FDA recently solicited public comments on the term “natural” in food labeling, including a request for comments on whether FDA should formally define the term. In doing so, FDA expressly cited as a motivating factor various citizen petitions regarding use of the term “natural” in food labeling. While it remains to be seen whether FDA will take any action following the close of the comment period on May 10, 2016, it is clear that “natural” labeling is receiving increased attention.
The FDA Stance on “Natural”
To date, FDA has not promulgated a formal rule explaining if or when any food may be labeled “natural.” The closest that FDA has come to any position regarding “natural” is a 1993 notice in the Federal Register that states the use of the term “natural” on a food label is not misleading when “nothing artificial or synthetic . . . has been included in, or has been added to, a food that would not normally be expected to be in the food.”
Warning letters have also shed some light on what FDA has considered “natural.” For example, in November 2011, FDA issued a warning letter to Alexia Foods concerning an “all natural” claim on its “Roasted Red Potatoes & Baby Portabella Mushrooms” product, which contained the “synthetic chemical preservative” disodium dihydrogen pyrophosphate. The synthetic chemical preservative was an additive that FDA said “‘would not normally be expected to be in the food.’”
However, on November 10, 2015, FDA announced that it would be soliciting public comments on the use of the term “natural” in food labeling. The comment period opened on November 12, 2015, and while it was initially expected to close on February 10, 2016, FDA subsequently extended the comment period to May 10, 2016 “in response to requests for an extension to allow interested persons additional time to submit comments.” FDA is specifically seeking comments on whether or not it should define the term “natural,” and if so, how the term should be defined.
FDA is also seeking comments regarding how it should determine the appropriate use of “natural” in food labels, for example, whether it should consider manufacturing processes and whether the term should apply only to “unprocessed” foods. FDA stated that its decision to request comments is partly in response to three Citizen Petitions seeking clarification on the term “natural,” including one by the Grocery Manufacturers Association requesting that FDA “issue a regulation authorizing statements such as ‘natural’ on foods that are or contain foods derived from biotechnology,” and one asking the FDA to prohibit the use of “natural” in food labels altogether. FDA also explained that private litigation surrounding the term “natural” has led some federal courts to seek administrative determinations from FDA on whether or not food products containing genetically engineered ingredients or high fructose corn syrup may be labeled as “natural.”
In announcing its request for public comment, FDA acknowledged that it has not previously issued a rule formally defining the term “natural,” but it did refer to its “longstanding policy” that the term “natural” means that “nothing artificial or synthetic (including all color additives regardless of source) has been included in, or has been added to, a food that would not normally be expected to be in that food.” It remains to be seen whether or not FDA will take action after the current comment period.
Proposed Federal Legislation on Food Labeling
Recently, legislators in the U.S. House of Representatives and Senate have also proposed various bills that could affect the use of the term “natural” in food labeling. The Food Labeling Modernization Act (FLMA) of 2015 (an updated version of legislation by the same name introduced in the House in 2013) would amend the Federal Food, Drug and Cosmetic Act (FDCA) to clarify when a food labeled “natural” is misbranded. FLMA directs the Secretary of Health and Human Services to promulgate a rule defining the term “natural” in a manner “to exclude, at a minimum, the use of any artificial food or ingredient (including any artificial flavor or added color) or any synthetic substance” and “based on data, including data on consumers’ understanding of the term as used in connection with food.” Corn syrup, high-fructose corn syrup and cocoa processed with alkali are among the ingredients that the act defines as “artificial.” The act also calls for the Secretary of Health and Human Services to “conduct consumer surveys and studies and issue a timely call for relevant public submissions regarding relevant consumer research, including with respect to consumer understanding of the term ‘natural” in relation to the term ‘organic’” and to “fully consider the results of such surveys and studies, as well as such public submissions.”
Given that a number of lawsuits regarding “natural” labeling involve the presence of genetically modified organisms (GMOs), it is not surprising that the issue of “natural” labeling has also come up in proposed legislation seeking to regulate the presence and labeling of GMOs in food. The Genetically Engineered Food Right-to-Know Act—originally introduced in 2013 and subsequently reintroduced in February 2015—would amend FDCA to require a food containing GMOs to reflect so in its labeling or risk being considered “misbranded.” The act also would prohibit the term “natural” in labeling of GMO-containing foods.
In addition, on July 23, 2015, the House of Representatives passed the Safe and Accurate Food Labeling Act (SAFLA), but, on March 16, 2016, the bill did not receive enough Senate votes to pass, with 48 senators voting for it and 49 voting against it. SAFLA would have established a federal system of voluntary labeling of GMOs in foods, as well as mandatory review by FDA to determine the safety of individual GMOs before they are brought to market. Furthermore, the act would have required FDA to enact regulations regarding the term “natural” in labeling for GMO foods within 30 months after enactment of the law. SAFLA would also have expressly precluded states from requiring mandatory GMO labeling and from banning GMO crops.
Litigation Involving “Natural” Labeling
In the meantime, the question of which foods should be permitted to bear “natural” labeling continues to be litigated in courts across the country. Initially, the majority of these lawsuits involved products containing high-fructose corn syrup, challenging Nature Valley chewy granola bars sold as “100% Natural” because they contained one or more ingredients that plaintiffs claimed to be non-natural, such as high fructose corn syrup. But over time, consumer class action claims involving “natural” labeling have expanded in scope.
More recently, a number of lawsuits have emerged across the country challenging the use of “natural” labeling on food products containing GMOs. As of late 2015, more than 80 cases had been filed concerning the labeling of snacks, cereals and other food products that allegedly contain GMOs, alleging that snack products labeled as “natural” were deceptively marketed and advertised because they contained genetically modified, artificial and/or synthetic ingredients; alleging as untrue and misleading General Mills’s representation that its Nature Valley granola bars were “100% Natural” because the products contain GMOs and “GMOs are not ‘natural’ and certainly not ‘100% Natural.’”
It remains to be seen whether FDA’s request for comment on the use of “natural” in food labeling will lead to more of these cases being stayed or dismissed on primary jurisdiction grounds.
The issue of “natural” labeling on foods continues to be discussed within FDA, before legislative bodies, within our courts and among consumers. As the landscape continues to evolve, food industry companies and their legal counsel are advised to keep up to date with emerging trends, changing legal standards, legislative movements and the possibility of regulatory response. In addition, companies considering submitting comments to FDA before the close of the comment period on May 10, 2016 should consult with experienced counsel and coordinate with leading industry groups.
Nilda M. Isidro, Esq., is a partner at Goodwin Procter LLP in New York City and member of the firm’s Food Industry Group, which provides strategic counseling to food, beverage, and supplement businesses on a range of issues, including product launches, regulatory compliance, labeling and warnings issues, litigation avoidance and risk management. She is also a member of Goodwin Procter LLP’s Products Liability & Mass Torts Practice, specializing in food, supplements, medical devices and pharmaceuticals. This article states opinions of its authors, and does not necessarily represent opinions of Goodwin Procter LLP or its clients. Ms. Isidro would like to thank Lindsay Hoyle for her assistance with this article.
2. 58 Fed. Reg. 2302, 2407 (Jan. 6, 1993).
3. FDA Warning Letter to Alexia Foods, Inc. (Nov. 16, 2011).
4. Id. (quoting 58 Fed. Reg. 2407).
6. 80 Fed. Reg. 80, 718 (Dec. 28, 2015) (to be codified at 21 C.F.R. pt. 101).
7. 80 Fed. Reg. 69, 905 (Nov. 12, 2015) (to be codified at 21 C.F.R. pt. 101).
8. H.R. 4061, 114th Cong. (as proposed Nov. 18, 2015); S. 2301, 114th Cong. (as proposed Nov. 18, 2015).
9. H.R. 4061 § 4; S. 2301 § 4.
10. H.R. 4061 § 11; S. 2301 § 11.
11. H.R. 913, 114th Cong. (as proposed Feb. 12, 2015); S. 511, 114th Cong. (as proposed Feb. 12, 2015).
12. Safe and Accurate Food Labeling Act, H.R. 1599, 114th Cong. (as passed by H.R., July 23, 2015).
13. Wright v. Gen. Mills, Inc., Civ. No. 08cv1532 L(NLS), 2009 WL 3247148, at *1 (S.D. Cal. Sept. 30, 2009).
14. Class Action Compl. at 1-5, Korn, et al. v. Snyder’s-Lance Inc., No. 3:15-cv-02593 (N.D. Cal. June 10, 2015) (Dkt. 1).
15. Second Am. Class Action Compl. at 3, 4, 8-17, Rojas v. Gen. Mills, Inc., No. 12-cv-05099-WHO, 2014 WL 1248017 (N.D. Cal. Mar. 26, 2014).
Listeria Monocytogenes Outbreak Linked to CRF Frozen Produce
Soruce : https://foodpoisoningbulletin.com/2016/listeria-monocytogenes-outbreak-linked-to-crf-frozen-produce/
By Linda Larsen (May 3, 2016)
CRF Frozen Foods of Pasco, Washington is expanding its April 23, 2016 recall of frozen organic and traditional fruits and vegetables for possible Listeria monocytogenes contamination. There is an outbreak linked to these products, according to the Centers for Disease Control and Prevention (CDC). The CDC has not posted any information about this outbreak yet. We will keep you informed when they do.
At least seven people in three states have been sickened and were hospitalized with listeriosis, the illness caused by this pathogenic bacteria. The CRF press release at the FDA states “some of these illnesses have been linked to consuming CRF-manufactured or processed products.” Two of those sickened have died, but listeriosis was not the cause of death in either person.
You can see the huge list of recalled products at the FDA web site. There are 358 consumer products sold under 42 separate brand names. The recalled products include organic and non-organic broccoli, butternut squash, carrots, cauliflower, corn, edamame, green beans, Italian beans, kale, leeks, lima beans, onions, peas, pepper strips, potatoes, potato medley, root medley, spinach, sweet potatoes, various vegetable medleys, blends, and stir fry packages, blueberries, cherries, cranberries, peaches, raspberries, and strawberries.
The brand names of the recalled products are Bybee, Columbia River Organics, Northwest Growers Select, Organic by Nature, C.H. Belt’s, Chef Maxwell, Correct Choice, Earth’s Pride, Endico, Farmer’s Bounty, Fiesta Mart, The Inn, Live Smart, Parade, O Organic, Panda Express, Pantry Essentials, Safeway Kitchens, Signature Kitchens, Trader Joe’s, USDA, VIP, Wellsley Farms, JFDA, McCain, Mity Fresh, Mountain Mist, Overhill Farms, Veggie Maria, Life Foods, Emerald Farms, Endico, Great Value, James Farm, Kirkland Signature, Price First, Quirch, Season’s Choice, Simply Nature, True Goodness, Wild Oats, and Export. You can see UPC numbers, codes, and best by dates of the recalled foods at the FDA site. Look through that list carefully.
If you have purchased any of these products, do not use them, even if you cook them before serving. Foods cooked in the microwave may have cold spots where the bacteria could survive. Throw the packages away in a sealed container, or return them to the place of purchase for a refund. Wash your hands well after handling these products.
Then you should clean your refrigerator or freezer with a mild bleach solution of one tablespoon liquid chlorine bleach to one gallon of warm water to kill any bacteria. Rinse any closed and unopened packages of food with this solution as well, then rinse in clear water. Listeria monocytogenes bacteria can grow at refrigerator temperatures, and freezing does not kill it.
If you ate any of these recalled products, watch yourself for the symptoms of Listeria monocytogenes food poisoning for the next 70 days. That is how long it can take for the symptoms to appear, although symptoms usually appear within three weeks.
Symptoms of listeriosis include flu-like fever and muscle aches, upset stomach or diarrhea, stiff neck, headache, and loss of balance. Pregnant women can suffer premature labor, stillbirth, or miscarriages if they contract this illness, even though their symptoms may be very mild. If you do experience any of these symptoms, see your doctor as soon as possible and tell her you ate one of these recalled products.
Good and bad news about Salmonella in retail meat, poultry
Source : http://www.foodsafetynews.com/2016/05/good-and-bad-news-about-salmonella-in-retail-meat-poultry/#.Vy_zT07yWUl
By News Desk (May 02, 2016)
A new interim report from the U.S. Food and Drug Administration (FDA) measuring antimicrobial resistance in Salmonella isolated from raw retail meat and poultry found both encouraging and concerning trends.
The report included whole-genome sequencing data for the first time, FDA noted, and analyzed data from January 2014 through June 2015 collected through the National Antimicrobial Resistance Monitoring System (NARMS).
The retail meat arm of the NARMS program collects samples of grocery store chicken, ground turkey, ground beef and pork chops and tests for non-typhoidal Salmonella, Campylobacter, Escherichia coli and Enterococcus to determine whether such bacteria are resistant to various antibiotics used in human and veterinary medicine.
However, this latest interim report, released April 28, only tested for Salmonella. Information reported includes serotype distribution, prevalence by food source and state, selected resistance patterns, and a list of all the identified antimicrobial resistance genes.
FDA reported “encouraging improvements” in the 2014-2015 data. These included:
•The prevalence of Salmonella in retail poultry is at its lowest level since testing began in 2002. In ground turkey, the prevalence of Salmonella has declined from a high of 19 percent in 2008 to 6 percent in 2014. In retail chicken over the same time period, it has dropped from 15 percent to 9 percent, FDA reported.
•Salmonella resistance to ceftriaxone (an important antibiotic used to treat seriously ill patients) from chicken sources continued to decline steadily from a high of 38 percent in retail chicken meats in 2009 to 18 percent in 2014, and 5 percent during the first half of 2015. In ground turkey isolates, ceftriaxone resistance was detected in 7 percent of 2014 isolates and 4 percent of 2015 isolates collected through June, which represents an 80-percent decline since 2011 when resistance peaked at 22 percent, the agency noted.
•Fluoroquinolones like ciprofloxacin are classified as critically important for the treatment of Salmonella infections. Ciprofloxacin resistance was absent in Salmonella from poultry and beef, although a single isolate was found in pork.
•All Salmonella from retail meats were susceptible to azithromycin, another important antibiotic recommended for the treatment of Salmonella and other intestinal pathogens.
•Multidrug resistance in Salmonella continued to show a downward drift in chicken and turkey from 2011 levels of 45 percent and 50 percent, respectively, to 20 percent and 36 percent in June 2015, FDA stated.
The agency also noted some “findings of concern” in the 2014-2015 data. They were:
•FDA identified the first instance of ciprofloxacin resistance in an isolate from retail pork and identified the genes associated with this resistance for future tracking.
•One ceftriaxone-resistant retail chicken isolate from 2014 had the extended-spectrum β-lactamase (ESBL) gene blaCTX-M-65. This is the first time this important class of resistance gene was detected in the U.S. This ESBL gene causes resistance to β-lactam antibiotics, including third-generation cephalosporins, resulting in fewer treatment options for infected patients, FDA reported.
•While only three isolates of Salmonella serotype Dublin were recovered from meats (ground beef) in 2014, they exhibited extensive resistance patterns as in the past, showing resistance to 9-12 of 14 drugs tested.
Whole-genome sequencing (WGS) data can be used to predict antimicrobial resistance for a number of bacteria, including the foodborne pathogens Salmonella, Campylobacter, and E. coli, FDA noted. In addition, WGS data reveal the range of genes causing resistance to a particular antibiotic. The agency has included comprehensive genetic data for the first time in a NARMS report, listing the antimicrobial resistance genes and resistance-associated mutations for Salmonella.
Whole genome sequence data are published for all 271 retail meat isolates from 2014 and 114 Salmonella isolated in the first half of 2015. These data for Salmonella will be a component of routine NARMS surveillance practices and the isolate-level data is now posted here.
To provide NARMS data in a timelier manner, FDA intends to issue retail meat interim reports twice per year.
NARMS was established in 1996 as a partnership between FDA, the Centers for Disease Control and Prevention, and the U.S. Department of Agriculture to track antibiotic resistance in foodborne bacteria for drugs that are considered important in human medicine, including whether they are multidrug resistant (resistant to three or more classes of antibiotics).
NARMS monitors trends in antimicrobial resistance among foodborne bacteria collected from humans, retail meats and food animals and assists FDA in making data-driven decisions on the approval of safe and effective antimicrobial drugs for animals.
No checklists? Your food safety plan is incomplete
Source : http://www.foodsafetynews.com/2016/05/no-checklists-your-food-safety-plan-is-incomplete/#.Vy_0CU7yWUl
By Coral Beach (May 2, 2016)
There’s a reason Santa and Mom always use checklists. They work.
It’s no different in the realm of food safety. Make a list, check it twice, have a backup plan. In many ways, that’s what the Food Safety Modernization Act (FSMA) and its accompanying rules are all about — preventing problems through a systematic, science-based approach.
Food businesses along the supply chain, from the fields all the way to the grocery store shelves, must be in compliance with various aspects to the FSMA rules beginning this fall. A phase-in approach gives medium-sized and smaller operations more time.
Signed into law in January 2011, the FSMA gives the Food and Drug Administration new tools in the quest for safer food through preventive efforts, rather than the reactive approach that had been the norm. Two key areas of the law include:
•Mandated inspection frequency: The FSMA establishes a mandated inspection frequency, based on risk, for food facilities. All high-risk domestic facilities had to be inspected within five years of enactment of FSMA and no less than every three years thereafter.
•Records access: FDA will have access to records, including industry food safety plans and the records firms will be required to keep documenting implementation of their plans.
For decades food businesses have faced government inspections from local, state and federal entities, spurring last-minute checklists for tidying up operations. In more recent times, third-party food safety audits, boosted by requirements from retailers and ingredient buyers, resulted in similar spot preparations for spot checks.
Such inspections and audits provided a snapshot of an operation’s food safety status on a given day but did little to ensure the routine and repeated execution of food safety procedures. Part of the rational behind the FSMA’s accompanying rules, as described by FDA Deputy Administrator Mike Taylor is to help food producers, handlers and retailers develop and consistently apply policies and protocols so those snapshots of food safety become more like streaming video — uninterrupted processes and procedures that are part of every employee’s work every day.
Norovirus Outbreak Sickens Carleton College Students
Source : https://foodpoisoningbulletin.com/2016/norovirus-outbreak-sickens-carleton-college-students/
By Linda Larsen (May 2, 2016)
A norovirus outbreak has sickened at least 22 Carleton students, according to the Minnesota Department of Health (MDH). Public health officials think that the students were sickened after they ate at Hogan Brothers’ Acoustic Cafe in Northfield, Minnesota. Hogan Brothers’ is a popular restaurant in town that serves custom made sandwiches.
The restaurant is temporarily closed to clean and investigate what happened. The college has set up a form to report any stomach illness among students and staff. The college itself is reporting that about 20 to 25 students are ill with symptoms of nausea, vomiting, and diarrhea.
The news release on Carleton’s website states that “it is very unlikely the illness is related to food served in any of the Carleton dining facilities.” The form is to help MDH and Student Health and Counseling (SHAC) track the outbreak. Students are only supposed to call if they have had symptoms that last for more than 24 hours. Carleton is asking that students who are sick stay in their rooms, don’t go to class, and don’t go to the dining hall. They are to rest and stay hydrated and have friends bring them food and drink.
Norovirus is spread through fecal or vomit-oral route. It is very contagious and can be contracted through contaminated food and drink, person-to-person, or by touching surfaces that someone who was ill touched previously. This illness is commonly and incorrectly known as the “24 hour flu” and is usually much more widespread during the cold winter months, when more people stay indoors. The Centers for Disease Control and Prevention (CDC) estimate that 23,000,000 people contract norovirus every year in the United States.
The symptoms of norovirus include nausea, vomiting, abdominal cramps, watery or loose diarrhea, a low grade fever, and muscle pain. Most people get better within a few days without medical treatment, but some can become dehydrated, especially if they can’t keep fluids down. Dehydration may prompt hospitalization, especially among those with chronic illnesses and weakened immune systems.
To prevent the spread of norovirus, always wash your hands well before eating or before preparing or serving food for others. Wash your hands with soap and water after using the bathroom and caring for someone who is sick. Stay home if you are sick, especially if you work in a school, medical facility, or daycare.
Keeping our food safe
Source : http://www.coastalleader.com.au/story/3881371/keeping-our-food-safe/
By coastalleader.com.au (May 1, 2016)
About 40 people brushed up on their food handling skills last week as they attended a free food safety training session, put on by TAFE SA.
While food safety training is mandatory for industries such as aged care, childcare and hospital staff, plenty of volunteers also attended as they brushed up on their food safety knowledge. There were representatives from the Lions club, Royal Flying Doctor Service, as well as those who work in the food industry.
Nigel Plunkett from TAFE SA ran the sessions, and explained that volunteers must have adequate skills and knowledge in regards to food safety, and that cases of food poisoning have doubled in the last five years. “People can die from food poisoning,” he said. “People don’t realise how easy it is to catch.
“Councils are starting to monitor food business to make sure they are compliant.”
The course, which ran over three hours, touched on standard hygiene practices, gave tips on how to keep food safe, such as using different coloured chopping boards and the penalties for serving unsafe food.
“(The fine is) $80,000 for having out of date products on their shelves,” Mr Plunkett said. “If in doubt, chuck it out.”
The program brings the training all over SA, especially to regional communities where it can be difficult, especially volunteers to access the information and training.
Mr Plunkett said the course was delivered to Bordertown, Millicent, Kingston. Robe and Naracoorte last week.
“We can come and deliver the training, by being able to access the free training… (it has) has allowed us to run the class today and get volunteers here.
“For volunteers they give up their time and what of them don’t realise is that the legislation affects them as well and it’s about safeguarding themselves…people don’t realise if you get it wrong, it can cause a lot of problems.
“The program’s been going around five years now, and it’s been huge.
“It really gives people a boost to keep doing what they’re doing, and that’s why this funding we’ve been able to access is great.”
Weekly Food Recall Roundup: May 1, 2016
Source : https://foodpoisoningbulletin.com/2016/weekly-food-recall-roundup-may-1-2016/
By Linda Larsen (May 1, 2016)
Our weekly roundup of recalls features products recalled for undeclared peanuts, some for Salmonella, and others for misbranding. This weekly feature will help you keep abreast of recalled products so you can protect yourself and your family. No illnesses or adverse reactions have been reported in connection with any of these recalled products.
CVS recalled Gold Emblem Abound Organic Spiced Herbal Tea for possible Salmonella contamination. The recalled product is packed in 1.4 ounce cartons, with a best by date of 18 Mar 2018. The UPC number for that product is 0 50428 541043. This product was sold at CVS Pharmacy stores nationwide.
Matlaw’s Raw EZ Peel Deveined Shell on Shrimp was recalled for possible Salmonella contamination, as revealed in the weekly FDA’s Enforcement Report. More than 32,000 pounds of the shrimp was recalled. It was sold in Ohio, Michigan, Indiana, Maryland, New York, Illinois, Texas, Florida, Wisconsin, Minnesota, Georgia, Pennsylvania, Utah, California, Oregon, New Jersey, and Tennessee. The recalled product has the lot number and best by date of: 20860R 20001Q Best By 02 23 17. In addition, the production codes and best by dates of: Production Code 26021023515; Best By 02 26 17 Production Code 26021023815; Best By 02 25 17 Production Code 26021023715; Best By 02 27 17 Production Code 26021023915; Best By 02 28 17 Production Code 26021024015; and Best By 02 24 17 production Code 26021023615 are recalled.
Krasnyi Oktyabr Inc. of New York recalled Vobla (Roach) Dry Eviscerated Salted Fish and Bream Dry Eviscerated Salted Fish because it may be contaminated with botulism toxin. The fish were not properly eviscerated, which increases the risk that it contains Clostridium botulinum bacteria. It was sold in retail stores in New York and California from February through April, 2016. The Vobla (Roach) Dry Eviscerated Salted Fish has a UPC number of 4606495-001308. The Bream – Dry Eviscerated Salted Fish has a UPC number of 4606495001346.
Chick Fil A Chocolate Chunk Cookies were recalled for undeclared peanuts. The products were sold at those restaurants nationwide. All of the best by dates of those cookies were in September and October 2016. They include lot number 1000146515 with best by date Sep/25/2016; lot number 1000146526 with best by date Oct/08/2016; lot number 1000148294 with best by date Sep/13/2016; lot number 1000153626 with best by dateSep/26/2016; lot number 1000155869 with best by date Sep/26/2016, and lot number 1000157620 with best by date Oct/03/2016.
7-Eleven Sugar Cookie Peanut Recall7-Eleven had four recalls for their cookies for undeclared peanuts. The first three recalls were for the cookies sold in 2-count clear plastic film containers. The first was for Fresh to Go brand Chocolate Chunk Cookies, Oatmeal Raisin Cookies, and Sugar Cookie with M&M Chocolate Candy; all were sold in New York state. The second recall was for 7-Eleven Fresh to Go Chocolate Chunk Cookie, Oatmeal Raisin Cookie, and Peanut Butter Cookie, sold in southern California. The third recall was for 7-Eleven Fresh to Go Sugar Cookies with M&M Chocolate Candy and Peanut Butter Cookies that were sold in Florida. And the fourth recall was for 7-Eleven Chocolate Chunk, sugar, and oatmeal raisin cookies sold in self-serve cases in Missouri, South Carolina, and Texas. Look at those recall notices carefully; all of the recalled products have different best by dates and UPC numbers.
Pilgrim’s Pride recalled many different poultry products for plastic, wood, rubber, and metal contamination. The long list of recalled products included Gold Kist Farms chicken patties, Sweet Georgia brand chicken tenderloins, and Pierce breaded chicken tenderloins, among others. Schools purchased these products nationwide. All of the recalled products have the establishment number “EST. 20728” inside the USDA mark of inspection.
True Nature Hummus and Pesto were recalled for undeclared soy and milk, according to the FDA’s weekly Enforcement Report. Original Hummus in 9 ounce containers was recalled for soy, Garlic Hummus in 9 ounce containers was also recalled for soy, and Arugula Hazelnut Pesto in 7 ounce containers, was recalled for milk. All of the recalled products had best by dates before March 9, 2016.
Halperns’ Steak and Seafood Company recalled 47 cans of Sebastian Crab Meat for possible time and temperature abuse. This means the product was not correctly processed and could present a health hazard. Sebastian Super Lump Pasteurized Crab Meat, Blue Swimming Crab Meat, Wild Caught, in 16 ounce cans, was sold in Texas.
Kopobbi Whole Milk Ricotta was recalled for possible Listeria monocytogenes contamination, in the FDA’s Weekly Enforcement Report. Forty-seven 17.14 pound tubs of the cheese, sold in New York, Massachusetts, and Pennsylvania was recalled. The product has a sell by date of 03/16/16, with lot number 16-26-02.
Season’s Choice Prince Edward Medley was recalled for Listeria monocytogenes contamination, according to the FDA’s Weekly Enforcement Report. More than 47,500 bags of this frozen vegetable product were recalled. The best before date is Jun 28 2017 with lot number 152212. It was sold in Illinois at Aldi stores.
Old Home Creme Cakes were recalled for undeclared peanuts. Lemon creme cake, vanilla creme cake, and strawberry swirl cream cakes, sold in Alabama, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Maryland, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, and West Virginia in multiple locations were recalled. Sliced Lemon Crème Cake has the production code 16104; Old Home Kitchens 14 ounce Sliced Vanilla Crème Cake has the production code 16104; and Old Home Kitchens 14 ounce Sliced Strawberry Swirl Crème Cake has the production code 16098.
Bi-Lo, Harveys, Winn Dixie Bakery Crème Cakes were also recalled for undeclared peanuts. They were sold at all BI-LO, Harveys and Winn-Dixie stores in Alabama, Florida, Georgia, Louisiana, Mississippi, North Carolina and South Carolina. The recalled products were sold between April 11, 2016 and April 26, 2016, with UPC numbers 205509000005, 205510000001, 205473000001, 205508000006, 205476000008, 205506000008, 205474000000, and 269740000002.
Foster Poultry Farms recalled chicken nuggets for extraneous blue plastic and black rubber materials.The recall was for 220,450 pounds of fully cooked frozen chicken nuggets in 5 pound bags with best by dates of 2/21/17 and 3/8/17, along with 10 pound bulk boxes of Fully Cooked Breast Nuggets with package codes 6053 and 6068. These products were sold in Alaska, Arizona, California, Utah, and Washington state. They have the establishment number “P-33901” inside the USDA mark of inspection.
Starbucks Wrap RecallStarbucks, Hannaford, and Turkey Hill wraps and salads were recalled because the maker, Greencore USA, made them outside inspection hours and without federal inspection. These products were shipped for distribution in Connecticut, Maine, Massachusetts, New Hampshire, New Jersey, New York and Rhode Island. Starbucks Southwest Style Wrap with dates of 4/10/2016 and 4/24/2016 are recalled, along with Starbucks Thai-Style Peanut Chicken Wrap with dates of 4/10/2016 and 4/18/2016. Starbucks Zesty Chicken & Black Bean Salad bowl with use by date of 4/28/2016 is recalled. Hannaford Italian Pesto Wrap with a use by date of 4/25/2016, and Asian-Style Salad with a use by date of 4/30/2016 are recalled. Turkey Hill Fresh To Go Grilled Chicken Ranch Wrap with a use-by date of 4/23/2016 is recalled.
Republic of Tea recalled their Organic Turmeric Ginger Green Tea because it may have been contaminated with Salmonella bacteria. The teas were sold in 50 count tins, bulk bags, and refill bags.
Dietary Supplement Recalls
Schnaffer Distributing Pronutri LLC recalled Re-VITA-lize tropical orange flavor liquid vitamin for undeclared soy and milk. The recall is for lot number 15554, sold in California, Washington, Oregon, Minnesota, Texas, and Iowa. The product is packaged in a 32 ounce white plastic bottle.
World’s Choice Products recalled Supreme Elixir, Kid’s Juice, and Xtreme Fiber Detox. Supreme Elixir is sold in 32 ounce containers, with lot numbers 15094, 15258, 15310, 15483, 16053 and 16091; Kid’s Juice was sold in 32 ounce containers with lot numbers 15104 and 15326; and Xtreme Fiber Detox was sold in in 1 pound, 8 ounce containers with lot numbers 15174, 15372, 15423, 15538 and 16051. The products were sold nationwide through mail order.
Finally, Black Gold X Advanced, 3rd Degree, and Black Label X capsules sold by Making It A Lifestyle were recalled because the products contained undeclared sildenafil and sibutramine, making them unapproved new drugs. Those products could have life-threatening side effects because sibutramine was removed from the market in 2010, and sildenafil is the active ingredient in Viagra, and could lower blood pressure to dangerous levels.
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