Microsoft word - fru september 2013.doc

Food Regulatory Update
September 2013
FDA Holds First Public Meeting on FSVP and Third Party Accreditation Tutorials on GRAS Notices, Additive Petitions Now Available in Six Video FDA Reveals Pilot Program Aimed to Accelerate the Detection of Hazards in FOOD REGULATORY UPDATE
FDA Releases Data on Rice Samples Tested for Inorganic Arsenic
On September 6, FDA released its data on 1,100 samples of rice and rice products tested forinorganic arsenic. FDA assured consumers that the sample size tested is large enough toaccurately measure inorganic arsenic levels in products sold in the U.S. market by noting thatit has been characterized as the largest collection of rice samples analyzed for inorganicarsenic in the world. The agency tested several types of rice grains for inorganic arsenic,such as white, jasmine and basmati, and various types of rice products such as infant andtoddler cereals, pasta, grain based bars, snacks, cookies, desserts and beverages. The ricesamples included both domestic and foreign rice grains and rice products. FDA found thatthe average levels of inorganic arsenic ranged from 2.6 to 7.2 micrograms (mcg) per servingin rice grains and an average level of 0.1 to 6.6 mcg per serving in rice products. The highestlevels of inorganic arsenic found among rice grains was 11 mcg/serving in three samples thatoriginated from Texas, Louisiana, and California, and 30 mcg/serving in a hot ready to-eatrice bran cereal. FDA concluded that the levels of inorganic arsenic it found are too low tocause short-term health problems, and cannot reassure consumers that the levels detectedwould not cause long-term health effects until it completes a risk assessment. It has finisheddesigning the risk assessment and plans to publish its findings in 2014. The agency willdetermine if further action, such as setting an action level or publish guidance to industry, isnecessary after the risk assessment is completed.
See: FDA Holds First Public Meeting on FSVP and Third Party Accreditation Proposals
FDA held its first of three public meetings on its Foreign Supplier Verification Program(FSVP) and Third Party Accreditation proposals on September 19-20 in Washington, D.C.
Stakeholders were invited to present their questions regarding the provisions of the proposalsto a panel of FDA officials, which included Mike Taylor, the deputy commissioner for foodsand veterinary medicine. Among the many issues discussed during the meeting, there was adifference of opinion among segments of the food industry on the two different approaches toonsite audits, Option 1 and Option 2, which FDA had asked for comment on when it firstreleased its proposal on July 29. Option 1 would require importers to conduct onsite auditingof foreign suppliers for microbiological hazards in certain raw commodities that pose aserious health risk, and allow more flexibility for foods posing lesser hazards. Option 2would allow the importer to choose among several options, including onsite auditing,sampling and testing, record reviews or other techniques, to verify hazards being controlled.
Taylor provided input on the issue by stating that FSVP needs to embrace state of the artpractices and other less sophisticated systems in conducting supplier verification; and addedthat FDA struggles with balancing between making the requirements too prescriptive andmaking them clear enough so standards ensure adequate verification. Stakeholders’ alsoquestioned the officials on whether foreign suppliers were being held to stricter standards since the domestic preventive controls do not include supplier verification requirements forU.S. facilities. Taylor responded by stating that FDA fully anticipates the final preventivecontrols rule will include supplier verification provisions, so there will be consistencybetween the two. See: CFSAN Issues its Plan for Program Priorities in 2013-2014
FDA’s Center for Food Safety and Applied Nutrition (CFSAN) recently released its Plan forProgram Priorities for the rest of 2013 and 2014. For the remainder of 2013, CFSAN plansto: (1) publish final regulations on infant formula; (2) release draft guidance on reducingacrylamide levels in certain foods; (3) release draft guidance on new dietary ingredients(NDIs); (4) publish proposed rules to update the Nutrition Facts label and serving sizeinformation; (5) release advice on fish consumption; (6) publish final guidance to helpmanufacturers who wish to voluntarily label their foods as being made with or without theuse of bioengineered ingredients; (7) advance a plan for promoting broad, gradual reductionof added sodium in the food supply; and (8) release a plan to further reduce the use ofpartially hydrogenated oils.
For 2014, the agency plans to: (1) determine arsenic guidance levels for other foods; (2)develop a draft proposed rule on recordkeeping requirements for high-risk foods to facilitatetracking; (3) publish draft conflict of interest guidelines for experts participating on GRASpanels; (4) publish the final guidance on NDI’s for dietary supplements (5) publish draft riskassessment for arsenic in rice and rice products; (6) complete projects on Salmonellacontamination in tomatoes and peppers; (7) release updated good agricultural practices indraft guidance; (8) publish draft guidance on substantiating structure function claims; (9)issue final rules for updating the Nutrition Facts panel and serving size information; (10)publish a proposed rule on dietary guidance statements in food labeling; (11) release its finalplan for implementing a sodium phase down in the food supply in 2015; and (12) publish thefinal rules that will require nutrition information to be displayed on menus of restaurants with20 or more locations and on vending machines.
CFSAN also mentions that it plans to conduct several internal reviews for the remainder ofthis year and in 2014. In 2013, it plans to complete a review of its Office of Food Safety toidentify a structure and set of structures that will enable it to achieve and maintain highlyefficient operations, especially in light of the need to implement the Food SafetyModernization Act. In 2014, CFSAN plans to review its “nutrition and related activities toidentify, with respect to nutrition in America, what problems we have now, in the near future,and in the next 10-15 years, and how CFSAN might best address them.” See: Tutorials on GRAS Notices, Additive Petitions Now Available in Six Video Series
FDA recently launched a video series featuring instructions for companies and individuals onfiling GRAS notices for substances to be recognized as safe for use, as well as step-by-stepprocedures for submitting additive petitions. The series is a new tool that reminds users thatFDA does accept petitions and notices electronically through a secure website, and provides guidance on the information that is required on those documents. The first video, Module 1,features Dennis Keefe, the director of FDA’s Office of Food Additive Safety (OFAS), whoprovides an introduction to the role of OFAS, in addition to a walk-through on how to submitforms electronically. The rest of the Modules are dedicated to specific submissions. Module2 provides information on food and color additive petitions and master file submissions;Module 3 features information regarding food contact notifications, pre-notificationsconsultations and food master file for food contact substances; Module 4 is dedicated toGRAS notices; Module 5 is for information specific to biotechnology final consultationsubmissions; and Module 6 includes information on new protein consultation submissions.
See: FDA Reveals Pilot Program Aimed to Accelerate the Detection of Hazards in Foods
During the annual meeting of its Food Advisory Committee held on September 23, FDAannounced it is developing a pilot program featuring a new internal warning system to detectchemicals that pose long-term chronic health issues. The specifics of the program are laidout in a concept paper titled, Detecting Signals for Chemical Hazards of Concern in CFSAN-Regulated Products, which was published on the same day. The agency has been developingthis new system in response to the increasing public concerns in recent years regarding theneed to detect chemical hazards such as Bisphenol A (BPA) and melamine. The goal of thenew system is to help the agency identify chemical hazards more rapidly, keep senior leveldecision makers apprised of any hazards, improve communications within the Center forFood Safety and Applied Nutrition (CFSAN) and facilitate better data gathering. CFSAN isproposing to create the new position of Signal Manager, who will hold the most essential rolein the program. The Signal Manager will be responsible for synthesizing and analyzing awide range of information on signal detection from internal government data, such as theReportable Food Registry and the Total Diet Study, or from outside sources, such asliterature searches and international risk assessments. The Signal Manager will also beresponsible for prioritizing and gathering additional information, leading a review team, andwill have to report on findings once a month. The program will also feature a Signal ReviewTeam, which will act as an expert panel, which will include representatives from otherCFSAN offices and will be responsible for recommending actions on the chemicals orcommodities in question. See:and, CVM Issues Draft Guidance on Animal Feed Additive Petitions
On September 11, FDA’s Center for Veterinary Medicine (CVM) announced the availabilityof its new draft guidance intended to assist animal feed additive producers submit petitions inaccordance with the agency’s requirements. CVM’s guidance lists the pertinent informationthe agency believes petitioners should have upon preparing a submission, including information on: (1) how to determine if an animal food ingredient is already the subject of afeed additive petition, and, therefore, might be eligible for a GRAS notice instead; (2) who tocontact for more information about the feed additive petition process and how to submit apetition; (3) the importance of working with CVM before a petition is submitted in order toensure all pertinent information is available; (4) which FDA regulations and previouslyissued guidance documents should be consulted when preparing a petition; and (5) when andhow to submit study designs for CVM review. Comments on the draft guidance are due byNovember 12, 2013. See: 78 Fed. Reg. 55727 (September 11, 2013) at,and, FDA Updates Forms for Manufacturers of Low Acid Canned Foods
On September 18, FDA announced that it is modernizing the paper and electronic processfiling forms used by manufacturers of acidified and low acid canned foods to submitinformation about their processes. FDA plans to no longer use Form 2541a and Form 2541cand to begin using four new forms that are specific to the different industry manufacturingprocesses. The new forms include: (1) FDA Form 2541d, low-acid retorted method; (2)FDA form 2541e, acidified method; (3) FDA Form 2541f, water activity/formulation controlmethod; and (4) FDA Form 2541g, low-acid aseptic systems. The new forms will featureadditional data entry fields regarding the processes. FDA explained that the additional datathat will be requested on the new forms is information the agency would routinely have torequest during follow-ups, and assured manufacturers that it will not be asking forinformation beyond what is currently required. FDA says manufacturers should continueusing Forms 2541a and 2541c until the new forms are finalized and formally adopted.
Comments on the notice are due by November 18, 2013. See: 78 Fed. Reg. 57391(September 18, 2013) at, Court Denies Preliminary Injunction Against USDA’s Final Rule on COOL
On September 11, Judge Ketanji Jackson for the U.S District Court for the District ofColumbia issued a ruling for a preliminary injunction brought by a coalition of agriculturegroups in the U.S., Canada, and Mexico, against USDA regarding its final rule on country oforigin labeling (COOL). Judge Jackson notes that the plaintiffs in the case, which includethe American Meat Institute (AMI), National Cattlemen’s Beef Association, CanadianCattlemen’s Beef Association, and Mexico’s National Confederation of LivestockOrganizations, appear to conflate the burden that they claim the final rule places on theirfinances with the burden it places on their speech. Therefore, Judge Jackson sided withUSDA and agreed that the final rule “mandates purely factual and uncontroversialdisclosures about where an animal was born, raised and slaughtered.” In a statement issuedin response to the ruling, AMI expressed its disappointment towards the ruling to deny thepreliminary injunction. AMI further stated that several aspects of the ruling are susceptible to challenge for which the group intends to pursue on appeal. See: FSIS Study on Beef and Veal Carcasses Aims to Resolve Contamination Issues
On September 13, USDA’s Food Safety and Inspection Services (FSIS) announced a 12-month baseline study the agency plans to conduct on beef and veal carcasses to gatherinformation on contamination at slaughter and processing facilities. FSIS inspectors willcollect samples from steer, heifer, cow, bull, tag, dairy cows and veal carcasses in slaughterfacilities in two points along the processing floor, (1) immediately after hide removal, pre-evisceration, and before going into the chiller; and (2) after all antimicrobial interventionalhave been applied. The baseline study will “provide FSIS the data on percent positives andquantitative levels of select foodborne pathogens such as Salmonella, E. coli O157:H7 andnon-O15 Shiga-toxin producing E. coli and levels of total bacteria, generic E. coli, coliforms,and Enterobacteriaceae. FSIS will use the data collected from the baseline study to estimatethe national prevalence of those pathogens, develop performance guidelines to assess processcontrol across the industry, and to support additional policy considerations. Approximately200 establishments will be included in the baseline study, including 184 beef carcassprocessing establishments and 16 veal processing establishments. Inspectors will collect arelatively large number of samples from smaller facilities since there are more small and verysmall processors than larger ones. A total of 2,612 beef carcass samples and 576 veal carcasssamples will be collected in establishments over the 12-month period. See: C. General
ITC Finds Lack of Federal Enforcement is Hurting U.S. Olive Oil Producers
On September 12, the U.S. International Trade Commission (USITC) released a report titled,Olive Oil: Conditions of Competition Between U.S. and Major Foreign Supplier Industries.
The House Ways and Means Committee asked USITC to conduct an investigation of the U.S.
oil industry after the U.S. Trade Representative (USTR) reported the conditions in the oliveoil market expressed by U.S. olive oil producers. Specifically, U.S. olive oil producers hadvoiced concerns regarding mislabeled and adulterated olive oil entering the U.S market andargued that the issues among the industry are partly due to the lack of mandatory enforceableproduct standards and testing in the U.S. USTR explained that the problem is largely amongthe “extra virgin” varieties, the highest quality products, since they can easily meet currentinternational standards, allowing the premium product to represent a wide range of qualities.
Additionally, there are also differences with regards to the definitions of premium oil andlower-quality oil among several countries. In the U.S., USDA standards define olive oil andolive pomace oil by sensory and chemical parameters, but the agency does not provide amechanism for enforcement and there are no penalties for noncompliance. USITC noted inits report that one of the reasons for the investment in U.S. olive oil production has sloweddown is “because of a concern among U.S. producers that their competitive position in thedomestic market is threatened by a lack of regulatory oversight.” USITC’s reported findingssupported the U.S. olive oil producer’s claims, as it specifically concluded that “broad and unenforced standards can lead to adulterated and mislabeled product, weakening thecompetitiveness of high-quality U.S. produced olive oil in the U.S. market, and further notedthat “many U.S. consumers are unable to distinguish quality differences and, as a result,gravitate towards less costly oils, giving an advantage to large bottlers that sell low-costimported product.” See: Report Outlines Issues caused by Current Food Date Labeling System
On September 18, the Natural Resources Defense Council and Harvard University released areport titled, The Dating Game: How Confusing Food Date Labels Lead to Food Waste InAmerica, which suggests the need for a national policy on electing “best by” or “sell by”dates for perishable food products. The report highlights five main shortcomings with thecurrent date labeling systems: (1) The lack of a binding, national standard, combined withnon-uniform state-based requirements, has led to an inconsistent system with no baselinerequirements for whether the date is affixed by a food manufacturer (i.e. how the product islabeled “use by,” “sell by,” “expires on,” etc.), resulting in consumer confusion and inabilityto rely on such labels; (2) the lack of a national system fails to meet the purpose of suchlabels, which was to “provide indicators of freshness, rather, this creates confusion and leadsmany consumers to believe, mistakenly, that date labels are signals of a food’s microbialsafety;” (3) a considerable amounts of avoidable food waste; (4) inconsistent practices which“harm the interests of manufacturers and retailers by creating increased compliance burdensand food waste at the manufacturer/retail level”; and (5) date labeling practices which“hinder food recovery and redistribution efforts by making the handling of past-date foodsadministratively and legally complex.” The authors of the report suggest several possiblesolutions to the issues above, including: (1) requiring food manufacturers to only place datelabels on packages with clear wording to express what the date actually means; (2)encouraging USDA and FDA to use their existing authority to specify what kind of dateinformation can or must be used on products; (2) requiring manufacturers to make “sell by”dates invisible to customers and used only for purposes of restocking; (3) providingadditional information for consumers on safe handling, cooking and refrigeration practices tohelp deter against contamination risks that occur when foods are not properly refrigerated;and (4) giving other indicators to consider when judging if a food is safe, like smell or color.
See: First Lady Hosts the First Healthy Foods Summit at the White House
On September 18, First Lady Michelle Obama hosted several food and media industryrepresentatives at the White House at the first new healthy foods summit. According to astatement issued by the White House, the meeting was convened to engage in a “constructivedialogue and collaborative process” for developing solutions that help families makehealthier choices, “including leveraging the power of marketing to promote healthy productsand decreasing the marketing of unhealthy products to kids.” During the meeting, severalfood, beverage, media, and entertainment companies were recognized for the progress madeon improving the foods that are marketed to children in the last few years. Obama noted thatonly two months after marketing vegetables with characters from the television show iCarly,sales of Birds Eye Vegetables increased by 20%. Additionally, Vidalia Onion’s ShrekCampaign resulted in a 50% jump in sales for its products as well. Furthermore, Elaine Kolish, director of the Children’s Food and Beverage Advertising Initiative (CFBAI)announced that Ferrero USA, is the newest company to join the 17 companies that have madea pledge to change their marketing techniques under the initiative by not engaging inadvertising directed towards children. Obama specifically asked all of those companies totake a step further and actually market healthy foods to kids, such as foods that have realnutritional value, and foods that are fortified with real fruits and vegetables, whole grains andlow-fat dairy. She further noted that a limit needs to be placed on the use of licensedcharacters on unhealthy foods. Obama also announced that she has joined the Partnership fora Healthier America’s launch of a new “Drink Up” campaign to promote water as thehealthiest choice. See: and, Legislators Propose Food Labeling Modernization Act
On September 19, Senator Richard Blumenthal (D-Conn.) and Representatives Frank Pallone(D-N.J.) and Rosa DeLauro (D-Conn.) introduced the Food Labeling Modernization Act. Ifenacted, the bill would direct the Secretary of Health and Human Services (HHS) to establisha single, standard format for front-of-pack nutrition information for all packaged foods. Itwould also direct HHS to: (1) publish a comprehensive guidance document for industry,which would clarify the scientific support needed to prevent false or misleadingstructure/function claims, and give HHS authority to compel companies to submit thesubstantiation documents to the agency; (2) update the definition of “healthy” to be based onthe most recent Dietary Guidelines criteria and establish a standard definition of “natural;”(3) require claims such as “made with whole grains” to only be permitted if the amount ofwhole grains is conspicuously disclosed on the product label as a percentage of total graincontent; (4) require the percentage daily value for calories and sugar, including added sugar,to be listed prominently on the Nutrition Facts label; (5) require any product containing anamount of food that could be consumed in a single sitting to state on the label that onecontainer contains one serving size; and (6) require the disclosure of the amount of caffeinecontained in a product if it is more than 10 milligrams. See: Codex Working Group Seeks Data on Rice Growing Practices
On September 20, the U.S. Codex Office announced that a Codex electronic working group(eWG) working on projects associated with the Discussion Papers on the Development of aCode of Practice to Prevent and Reduce Arsenic in Rice and on the Proposals for MaximumLevels for Inorganic Arsenic in Rice is searching for more data on rice and rice cultivation.
The eWG, chaired by Japan and China, is asking for the additional data on rice growingpractices as part of Codex’s consideration of ways to prevent or reduce arsenic contaminationand to set a recommended maximum level for inorganic arsenic in rice. The Codexcommittee recently agreed that test methods should be identified for determining inorganicarsenic in rice, a code of practice to control and prevent arsenic contamination should be prepared, and that member countries should provide occurrence data on inorganic arsenic inrice in order to move ahead with setting maximum levels. One of the Codex committees isrecommending a draft maximum exposure level of 300 parts per billion (ppb) for brown riceand 200 ppb for “polished” rice. The eWG will only accept responsive data that is submittedby using a specific template, which is available on the U.S. Codex website. See:.
A. Europe
MEPs Press for Labeling Rules on Ritual Slaughter
On September 9, a group of Members of the European Parliament (MEPs) submitted awritten declaration that insists the European Commission require ritually slaughtered animalsto be labeled. The MEPs argue that not having labeling on meat from animals that have beenritually slaughtered runs counter to the European Union’s (EU) rules prohibiting consumersfrom being misled. The MEPs point out that the EU’s 2005 directive on unfair commercialspractices (2005/29/EC) outlaws “misleading omissions liable to distort the transactionaldecisions of consumers.” They further assert that consumers in different member states haverepeatedly complained about “the absence of proper meat labeling legislation that wouldcomply with animal welfare standards and consumer protection requirements and wouldenable them to make an informed choice in line with their beliefs, conscience or religion.”The MEPs urge the Commission to “step up research into how to provide consumers with therelevant information and to take action with a view to introducing the labeling of meat andpoultry products from ritually slaughtered animals.” Under a separate welfare strategy for2012-2015, the Commission is to produce a report into the feasibility of labeling rituallyslaughtered meat by April 2014. However, this written declaration places more pressure onthe Commission to act. If it fails to do so, one of the authors of the declaration can ask forthe request to require the labeling ritually slaughtered animals to be placed on the agenda ofan upcoming meeting of the parliamentary committee responsible for the matter, whichwould be the committee on the Environment, Public Health and Food Safety. See:


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