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FDA’s Taylor: Don’t Expect Extended Comment Periods on Reproposed FSMA Rules

Don’t expect comment period extensions for the reproposed rules regarding the Food Safety Modernization Act (FSMA).

That’s what Michael Taylor, the Food and Drug Administration’s deputy commissioner for foods and veterinary medicine, told attendees Wednesday at the United Fresh Produce Association Washington Conference.

He said he had hoped to be discussing details of the reissued produce safety, Foreign Supplier Verification Program (FSVP) and preventive controls rules during the meeting, but all four rules are still under review at the Office of Management and Budget.

FDA’s Michael Taylor addressing the United Fresh Washington Conference on Wednesday.

The new proposals are expected to be released soon, but Taylor was unable to give an exact date for when. All he would say was, “We are very close.”

The timeline for FSMA implementation is ever important, given that the first rules on preventive controls — both for human food and animal food — must be finalized by Aug. 30, 2015. FDA’s other court-mandated deadlines are Oct. 31, 2015, for produce safety, FSVP and third-party accreditation; March 31, 2016, for sanitary transport, and May 31, 2016, for intentional adulteration.

“The court deadlines are really driving all of the timelines and planning that we’re doing, necessarily,” Taylor said. “My boss is potentially held in contempt if we don’t get the rules out.”

He added that there will still be “a reasonable comment period” on the re-proposals “given that these are not new issues,” but that extended periods are not very feasible when sticking to the final deadlines.

Taylor also provided attendees with an overview of the changes coming from FSMA regarding produce companies.

Michael Taylor

At the end of his remarks, Taylor again emphasized the need for adequate resources for implementing FSMA. As budget presentations have stated, FDA needs the funding to develop guidance and provide technical assistance for industry, provide technical support for FDA inspectors, retrain the federal and state inspection force, and build the import oversight system mandated by FSMA.

I’m a broken record on this, but I’m duty-bound and it’s deadly serious stuff,” Taylor said. “There is a lot ahead of us … but it’s clearly worth it.”

Speaking with reporters afterward, Taylor said that FDA “got the message on fees” and that, although the 2015 budget is still pending, “2016 really becomes the crucial year for getting the budget that we need to successfully implement.”

Food Safety News

Groups Ask OMB, USDA to Release Revised Poultry Rule for Public Comment

Organizations representing workers and consumers want the Department of Agriculture to follow the Food and Drug Administration’s lead by releasing the revised poultry inspection rule for public comment.

Last week, the USDA’s Food Safety and Inspection Service (FSIS) submitted a draft final version of its Modernization of Poultry Slaughter Inspection rule to the Office of Management and Budget (OMB) for review.

At the time, an agency spokesperson said, “Although we do not discuss the specifics of a rule under review, the draft rule has been significantly informed by the feedback we received from our stakeholders, as well as from our interagency partners such as the Department of Labor.”

But, in a July 16 letter to Agriculture Secretary Tom Vilsack and Howard Shelanski, administrator for OMB’s Office of Information and Regulatory Affairs, the Safe Food Coalition argued that “stakeholders have no information about what those changes entail.”

The group wants to see the revised rule released to the public for public meetings and a 120-day comment period — not a requirement under normal rule-making procedures.

“We have raised numerous concerns about the negative impact USDA’s proposal will have on food safety and consumer protection,” wrote signatories Center for Foodborne Illness Research & Prevention, Center for Science in the Public Interest, Consumer Federation of America, Consumers Union, Food & Water Watch, Government Accountability Project, National Consumers League and STOP Foodborne Illness.

The American Federation of Government Employees — the poultry inspectors’ union — sent a similar letter stating, “Many other labor unions, consumer groups, members of Congress, and even federal government agencies have raised concerns as well.”

AFGE Legislative and Political Director Beth Moten wrote that, because the rule is so important, “stakeholders and the public should be given the opportunity to comment on the ‘significant changes’ made to the proposed rule before it is finalized.”

Re-releasing the rule would not be unprecedented. By the end of the summer, FDA will release revised language for the Food Safety Modernization Act’s rules regarding human food preventive controls, animal food preventive controls, produce safety and the Foreign Supplier Verification Program.

The same move for the poultry inspection rule would enhance transparency, the groups said.

“The USDA needs to come clean about what changes it has since made to the rule,” stated the Organic Consumers Association in its call for public comment. “Otherwise, the agency’s lack of transparency on this issue leaves us wondering what it is hiding.”

When asked whether FSIS plans to re-release the rule, a spokesperson told Food Safety News that the agency would have no further comment beyond last week’s statement that the rule had been submitted to OMB after incorporating stakeholder feedback — in particular, worker safety concerns.

Food Safety News

FSMA Sanitary Transportation Rule Comment Period Extended

The U.S. Food and Drug Administration has announced that it will be extending the comment period on the sanitary transportation rule issued under the Food Safety Modernization Act (FSMA).

The comment period was originally set to end May 31, but the deadline has been extended to June 30 in response to requests for additional time.

The rule is the seventh and final major rule of FSMA. It was proposed at the end of January and will require shippers, receivers and carriers who transport food by motor or rail vehicles to take steps to prevent the contamination of human and animal food during transportation.

FDA has already held three public meetings on the rule. At the meeting in College Park, MD, the issue of whether the rule’s exemption for live animals extends to shellfish was brought to the agency’s attention.

The final rule is required to be released by March 31, 2016.

Food Safety News

JICC seeks comment on coupon barcode retirement

The Joint Industry Coupon Committee is soliciting industry comments on its intent to retire the use of UPC barcodes on all coupons used in North America by June 30, 2015.


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The JICC plans to submit a request to GS1 to retire the UPC Prefix 5 and GS1 Prefix 99 symbols from use, to help move the industry away from a hybrid format and toward exclusive use of the GS1 DataBar symbol on coupons.

In addition to coupon redemption efficiencies, according to JICC, exclusive use of the GS1 DataBar can reduce incidences of intentional coupon fraud and unintentional coupon mis-redemption.

Stakeholders should submit comments to Jeanne Iglesias, senior director of industry affairs at GMA, by June 16, 2014, at [email protected].



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UK Pig Inspection Rule Changes Open For Public Comment

In June of this year, the European Union will introduce new rules for pig meat inspections designed to minimize the risk of bacterial contamination on pork.

The United Kingdom’s Food Standards Agency announced last week that it is requesting comments on the practical application of changes required by the rules.

These comments are being solicited from food business operators in FSA-approved pig meat establishments, pig farmers, and officials working in pig meat establishments. Comments on costs, benefits and wider impacts for stakeholders will also be accepted.

“The current system needs modernizing,” said Steve Wearne, director of policy at FSA, in a statement. “Our meat hygiene controls were developed more than a century ago to tackle the health concerns of the day. A modernized inspection system will protect consumers better and be more proportionate to slaughterhouses that control risks effectively.”

Wearne continued, “We want to ensure the new controls are proportionate and take into account the views of producers and consumers of pork. We look forward to hearing all of the views that come out of this consultation.”

The new rules are designed to help official veterinarians and meat inspectors better target public health risks in pig slaughter facilities and to control risks effectively. The new rules will focus on the visual inspection of all pigs to reduce the risk of bacteria being spread around the meat, FSA’s statement states.

Current practices utilizing hands-on inspection can result in the spread of harmful bacteria when a pig carcass or offal is handled and cut. Hands-on inspection will be carried out only where information from the farm or visual inspection at the slaughterhouse has identified potential concerns about an animal.

In addition to changes in inspection, stricter rules for Salmonella control and more risk-based testing for Trichinella, a parasite, will be implemented.

Responses to the consultations are required by May 6 in all U.K. countries except Scotland. Scottish stakeholders must respond in writing by April 28.

Food Safety News

FDA to Revise Animal Food Rule, Extends Other FSMA Comment Periods

A number of changes to the Food Safety Modernization Act (FSMA) implementation timeline were announced Wednesday.

First, the U.S. Food and Drug Administration plans to publish revised language for the proposed rule on preventive controls for animal food in early summer 2014, alongside the revised produce safety and preventive controls for human food rules.

FDA also plans to extend the comment period for other elements of FSMA.

The new deadline for the intentional adulteration and accompanying draft qualitative risk assessment will be June 30, a 90-day extension from the March 31 deadline originally set by the court. The announcement comes a week after FDA held its third and final public meeting on the rule in Anaheim, CA.

Because the agency will release a revised version of the animal food rule, the March 31 deadline for comments on preventive controls for animal food will remain despite calls for an extension from the grain and feed industry.

Richard Sellers, the American Feed Industry Association’s senior vice president of legislative and regulatory affairs, said that his organization is “disappointed” that FDA is not giving the industry more time to review the rule “provided the agency themselves was given an extension by the courts.”

Last on the list of Wednesday’s updates, FDA is also extending the comment period on the draft methodological approach to identifying high-risk foods an additional 45 days until May 22.

“The Agency is committed to providing adequate time to comment on proposed rules while recognizing the need to meet court-ordered deadlines for final rules,” reads an FDA statement.

FDA will officially announce the extensions in the Federal Register and will issue constituent updates to inform stakeholders.

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Grain and Feed Industry Asks for FSMA Rule Comment Extensions

Now that the U.S. Food and Drug Administration will no longer be held to deadlines for FSMA rule comment periods, industry groups are asking for more time to give their input on certain regulations.

The National Grain and Feed Association (NGFA), the American Feed Industry Association (AFIA), the Pet Food Institute (PFI) and the National Renderers Association requested that FDA extend the comment deadlines by 90 days for its proposed rule on preventive controls for pet food and animal feed and draft methodological approach to identifying high-risk foods.

Under this proposal, the animal food rules comment period would end June 30 and the high-risk food guidance on July 7. Some of the signatories also requested that FDA re-propose the animal food rule and offer a second comment period.

The NGFA, AFIA, PFI and the National Oilseed Processors Association (NOPA) also requested that FDA extend the comment period for the proposed intentional adulteration rule to June 30.

FDA’s current deadlines for open comment periods are March 15 for the environmental impact statement for the produce rule, March 31 for the animal food and intentional adulteration rules, April 7 for the draft methodological approach to identifying high-risk foods, and May 31 for the sanitary transportation rule.

Food Safety News

Grain and Feed Industry Asks for FSMA Rule Comment Extensions

Now that the U.S. Food and Drug Administration will no longer be held to deadlines for FSMA rule comment periods, industry groups are asking for more time to give their input on certain regulations.

The National Grain and Feed Association (NGFA), the American Feed Industry Association (AFIA), the Pet Food Institute (PFI) and the National Renderers Association requested that FDA extend the comment deadlines by 90 days for its proposed rule on preventive controls for pet food and animal feed and draft methodological approach to identifying high-risk foods.

Under this proposal, the animal food rules comment period would end June 30 and the high-risk food guidance on July 7. Some of the signatories also requested that FDA re-propose the animal food rule and offer a second comment period.

The NGFA, AFIA, PFI and the National Oilseed Processors Association (NOPA) also requested that FDA extend the comment period for the proposed intentional adulteration rule to June 30.

FDA’s current deadlines for open comment periods are March 15 for the environmental impact statement for the produce rule, March 31 for the animal food and intentional adulteration rules, April 7 for the draft methodological approach to identifying high-risk foods, and May 31 for the sanitary transportation rule.

Food Safety News

FDA Seeks Comment on Draft Approach for Designating High-Risk Foods

The U.S. Food and Drug Administration has released a draft methodological approach to identifying high-risk foods under the Food Safety Modernization Act (FSMA) and will seek comments and scientific data to help refine it.

FDA is required under section 204(d)(2) of FSMA to designate high-risk foods for which additional recordkeeping requirements are needed to rapidly and effectively track and trace such foods during foodborne illness outbreaks

The agency is seeking comment on alternative approaches for identifying these foods, the scoring system and how foods should be categorized.

The comment period opens Feb. 4. A deadline has not been announced.

Food Safety News

FDA Extends Comment Period on Trans Fats

WASHINGTON — The Food and Drug Administration has extended the comment period on its preliminary determination that partially hydrogenated oils — a source of artificial trans fats — are not safe to use to use in foods.

The FDA published its original recommendation to revoke the oils’ “generally recognized as safe” (GRAS) status on Nov. 8, with a 60-day comment period, but it has extended the comment period another 60 days, to March 8.


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“This extension is being provided in response to numerous stakeholder requests to provide additional time for comments,” the FDA said in announcing the extension.

Companies that wish to use ingredients that do not have the GRAS designation must petition the FDA to use them. On Tuesday, the American Academy of Family Physicians said it ‘strongly supported” the FDA’s effort to eliminate trans fats.

“We are pleased to wholeheartedly support the FDA’s determination that PHOs are not generally safe for use in food,” AAFP Board Chair Jeff Cain said in a statement.

The AAFP said it has found that partially hydrogenated oils contribute to obesity, have adverse effects on blood cholesterol levels, put patients at risk for coronary heart disease and contribute to insulin resistance — a precursor to diabetes.

Read more: FDA Recommends Phaseout of Trans Fats

In making her initial announcement about the effort to eliminate trans fats, FDA Commissioner Margaret Hamburg noted that many manufacturers and retailers already have moved to decrease the amount of trans fat in their products.

Still, she said, “While consumption of potentially harmful artificial trans fat has declined over the last two decades in the United States, current intake remains a significant public health concern. The FDA’s action today is an important step toward protecting more Americans from the potential dangers of trans fat.”

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Comment Period Extended for Trans Fat Determination

The U.S. Food and Drug Administration will be extending the comment period for its preliminary determination that partially hydrogenated oils (PHOs), a major source of artificial trans fat in processed foods, are not generally recognized as safe (GRAS) for use in food.

The determination was originally published int eh Federal Register on Nov. 8 and given a Jan. 7, 2014 deadline for comments. In response to stakeholder requests for additional comment time, FDA has extended the deadline until March 8.

Removing GRAS status from PHOs would mean they would be considered food additives and could not be used in food unless authorized by regulation.

Consumption of trans fat can increase the risk of coronary heart disease by raising low-density lipoprotein cholesterol, commonly referred to as “bad cholesterol,” and the Institute of Medicine has concluded that there is no safe level of consumption of trans fat.

According to the Centers for Disease Control and Prevention, removing PHOs from processed foods could prevent up to 20,000 heart attacks and 7,000 coronary deaths each year.

Food Safety News

FDA Gives Industry Another FSMA Comment Period

WASHINGTON — The Food and Drug Administration will allow the industry and public to comment on a second set of proposed Food Safety Modernization Art rules that deal with water quality, manure and compost standards and mixed-used facilities.

“We believe that this additional step to seek further input on revised sections of the proposed rules that need significant adjustment is critical to fulfilling our continuing commitment to getting these rules right,” said FDA Deputy Commissioner Michael Taylor in a media statement on Thursday.


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The produce industry was seeking another opportunity to comment on the next set of rules after submitting detailed comments requesting substantial changes to the initial proposed rules.

“There was a letter sent by members of Congress to say we want to make sure these laws are right. This is a huge change of food safety law in this country and there’s a number of members of Congress that are interested in seeing … the FDA submit another set of proposed rules that the industry can comment on,” PMA Washington representative Tom O’Brien told SN before the FDA made its announcement. 

Read more: PMA Sifts Through FSMA Myths

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Arsenic in Juice Comment Period Extended

WASHINGTON — The Food and Drug Administration has extended the comment period for its proposed action level for inorganic arsenic in apple juice by 60 days to Nov. 12, 2013.


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The draft guidance proposes an action level of 10 parts per billion of organic arsenic in apple juice. It is the same level set by the Environmental Protection Agency for arsenic in drinking water. The FDA considers this level protective of human health and achievable with the use of good manufacturing practice. 

The extension comes one week after FDA researchers determined that the level of arsenic found in rice and rice products is too low to cause health damage in the short term.

The FDA began investigating arsenic in juice in response to a Consumer Reports analysis that found arsenic levels exceeding federal drinking water standards in 10% of the 88 samples of apple and grape juice collected in New York, New Jersey and Connecticut for testing.

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FSIS Extends Comment Period for Tenderized Beef Labeling

The U.S. Department of Agriculture’s Food Safety and Inspection Service on Friday quietly extended the comment period for a long-delayed proposal to require labeling for certain tenderized beef products.

The move, which responds to industry requests, means that stakeholders will have 60 days longer, or until October 8, to weigh in on the proposed rule. Industry groups had asked for a 120-day extension, but the agency said it believes a 60-day extension is “sufficient.”

The rule, initially proposed on June 10, would require the term “mechanically tenderized” on the label for raw and partially cooked needle- or blade-tenderized steaks, including beef products injected with marinade or another solution, unless those products are fully cooked at an official establishment.

“FSIS is also proposing to require that the print for all words in the product name appear in the same style, color, and size and on a single-color contrasting background,” the notice states. “In addition, FSIS is proposing to require that labels of raw and partially cooked needle- or blade-tenderized beef products destined for household consumers, hotels, restaurants, or similar institutions include validated cooking instructions that inform consumers that these products need to be cooked to a specified minimum internal temperature, and whether they need to be held at that minimum temperature for a specified time before consumption, i.e., dwell time or rest time, to ensure that they are fully cooked.”

Interested parties should visit the Federal Register for information on submitting comments.

Food Safety News

FDA Makes FSMA Comment Extension Official

While Food Safety News and other news outlets have already reported that the U.S. Food and Drug Administration planned to extend the comment period for the preventive controls and produce safety rules when the agency released its import and third-party certification proposals, the FDA made that move official on Thursday.

The agency issued Federal Register notices to formally extend the comment periods on the proposed rules, Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food and Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption. The comment period has been extended 60 days until Nov. 15, 2013.

“This is the second and final extension of the comment period for these two rules,” FDA said. “The extension of the comment period also applies to the information collection provisions associated with the proposed rules.”

FDA is taking this action to allow interested persons the opportunity to consider the interrelationships between these two proposals, which were published on Jan. 16, 2013, and the two new proposed rules that were published on July 29, 2013, Foreign Supplier Verification Programs for Importers of Food for Humans and Animals and the Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications.

These four proposed rules are part of the foundation of, and central framework for, the modern food safety system envisioned by Congress in the FDA Food Safety Modernization Act (FSMA).

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