FDA Announces Two More Public Meetings on its Intentional Adulteration Proposed Rule

By Robert A. Hahn

The Food and Drug Administration has announced that it will hold two additional public meetings on its proposed rule “Focused Mitigation Strategies to Protect Food Against Intentional Adulteration.”  79 Fed. Reg. 5353 (Jan. 31, 2014).

On December 24, 2013, FDA published a proposed rule on food defense.  78 Fed. Reg. 78013.  Under the proposed rule, domestic and foreign food facilities that are required to register with FDA, unless exempt, would be required to implement written food defense plans with focused mitigation strategies to protect food against intentional adulteration by acts of terrorism.  The comment period for the proposed rule will end on March 31, 2014.

FDA will be holding three public meetings on the proposed rule:

Feb. 20, 2014:  College Park, MD (FDA’s Harvey W. Wiley Federal Building), from 8:30 am – 3:00 pm

Feb. 27, 2014:  Chicago, IL (Hilton Chicago), from 8:30 am – 2:30 pm

Mar. 13, 2014:  Anaheim, CA (Sheraton Park Hotel), from 8:30 am – 2:30 pm

The purpose of the public meetings is to inform the public about the proposed rule and the rulemaking process, to respond to questions about the proposed rule, and to provide an opportunity for interested persons to make oral presentations on the proposed rule.

Because space is limited, early registration to attend the public meetings is recommended.  You may register via email (nick.cane@nakamotogroup.com), fax (301-468-6536), phone (240-357-1176), or mail (Nick Cane, Nakamoto Group, Inc., 11820 Parklawn Dr., Suite 240, Rockville, MD 20852).  Electronic registration is encouraged.  Please include your name, title, firm name, address, and phone and fax numbers.

Requests to make an oral presentation must be submitted by the applicable deadline to: Juanita Yates, Center for Food Safety and Applied Nutrition, FDA, 5100 Paint Branch Parkway, College Park, MD 20740; phone: 240-402-1731; email: Juanita.Yates@fda.hhs.gov.  Such requests must include your name, title, firm name, address, phone and fax numbers, and the full text, summary, or comprehensive outline of the planned oral presentation.

FDA will be live be Web casting the public meetings.  In addition, transcripts and video recordings of the public meetings, once they are available, will be posted on FDA’s Food Safety Modernization Act website.

John Block: U.S. Corn and China’s Bad Faith Collide

By John R. Block, as published in the Des Moines Register

As complex as the world trading system has become, it still fundamentally relies on something as simple as trust — that nations and people will be as good as their word.

Most basically, it requires that those who enter into mutually agreed upon contracts will not violate those contracts whenever they see it in their short-term advantage to do so.

Unfortunately, we are now faced with more evidence that China has yet to fully embrace this concept.

The latest instance of Chinese misbehavior has to do with an innovative new GMO corn — called Viptera — that was created to withstand insect devastation. It is so popular with farmers that it now accounts for some 10 percent of all corn in the United States, according to media reports. I have grower friends who use it on their corn acres.

As with all GMO varieties, the trait went through an exhaustive regulatory process ensuring its safety — both in the United States and key growing and grain-importing countries around the world — and is now relied on by farmers and consumers in the European Union, Latin America and Japan, as well as the U.S. For reasons known only to the Chinese government, however, it has so far been unwilling to complete this trait’s review.

Until recently, that fact had not prevented the Chinese from importing tens of thousands of tons of Viptera corn, which by the nature of the distribution process is, practically speaking, inseparable from other corn. Suddenly in November, however, the Chinese started turning away corn shipments in which the trait was detected.

Many have speculated on the reasons behind this latest Chinese action. But the simplest explanation is probably the best: China simply wants out of the corn contracts it signed when the price of corn was higher than it is today.

This year’s bumper harvests mean that global prices have already dropped by some 40 percent. Meanwhile, the Chinese appetite for imported corn continues to grow, from 5.23 million tons last year to an expected 7 million in 2013-14.

One thing is for certain: The issue is not GMOs or supposed concerns about their safety. Almost all the corn China imports from the U.S. is genetically modified in one way or another, and even while turning away ships with U.S. corn, China continues to accept shipments with the Viptera trait from Argentina.

U.S. Agriculture Secretary Tom Vilsack traveled to China in December in order to suggest to the Chinese that they fix their regulatory approval process, which doesn’t even begin until a producing country has finished its own. As part of that, he discussed a pilot project between our two nations in which the Chinese would start their regulatory review “in synchrony” with the U.S., so the entire world wouldn’t have to wait an extra two years — which is how long it takes in the best of circumstances — to bring innovative new traits to market.

The bigger issue is one that Secretary Vilsack could probably only hint at: It’s time for the Chinese to start acting responsibly on the world stage. China enjoys a huge trade surplus with the United States, and it should respect the fact that fair trade goes both ways.

China’s actions create huge uncertainties and costs in our global trading system and threaten to undermine the kind of technological innovation in agriculture that will allow us to feed a growing, calorie-hungry world population — much of which happens to reside in China.

The ultimate message should be this: that innovation must go forward, regardless. Western growers and technology innovators can’t allow the bad actions of one nation to hold back progress for the rest of the world.

John Block was Secretary of the U.S. Department of Agriculture from 1981-1985, where he played a key role in the development of the 1985 Farm Bill.

RMA “Self Certification”: Can Federal Crop Insurance AIPs Rely on It In Defending Against Farmer Claims?

By Kenneth D. Ackerman

Federal crop insurance provided by USDA’s Federal Crop Insurance Corporation (FCIC) and participating private companies (Approved Insurance Providers or AIPs) is often described as a program based on “self-certification.”  Farmers annually report their own acreage, ownership, yield histories, and other key information, mostly on an honor system.  FCIC and AIPs require support documents, and can investigate after the fact, but the system largely depends on honest people telling the truth.

To make it legally enforceable, participating farmers must sign the documents they submit to FCIC and their AIPs, certifying that information is accurate.  If later investigation finds the farmer misreported, then penalties – sometimes severe – can be imposed.

AIPs often depend on these certifications in denying indemnity claims, especially claims based on errors or false statements in the farmer’s reports.  But this protection for AIPs is far from absolute, especially where the AIP (or its agent) bears some responsibility for giving the farmer bad advice.

One recent Arbitration case tested the outer limits of this system.  The AIP in this case had received an inquiry from RMA that one of its insured farmers was owned by a foreign national – a potential violation of FCIC ownership rules.  But the farmer failed to report the foreign national on his insurance application as an SBI (Substantial Beneficial Interest) because the ownership interest was too distant.  Simply put, the foreign national owned an owner of an owner of an owner of the farm (fourth tier).  Most industry professionals understood the RMA rule to require reporting only of two tiers (the farm and its immediate owner).  On first hearing RMA’s concern, the AIP studied the issue and stuck with its initial reading that the policy was correct – only two tiers of ownership needed to be reported.  The farmer, based on this advice, continued not to report the distant owner.

A few years later, this case ended up in litigation.  The AIP found itself opposing the farmer, claiming the coverage was void due to the undisclosed ineligible foreign owner.  The AIP argued (among other things) that the farmer had failed in his “self-certification” duty by failing to report the foreign owner – even based on the advice of the AIP itself.  RMA, talking through an expert witness, largely sided with the AIP.

This raised a question: Could the FCIC policy actually penalize an insured farmer for an incorrect certified answer on a crop insurance application, when the insured based that answer on advice from the AIP, which in turn had based its opinion on a reasonable reading of RMA rules?  We assisted this farmer in arguing that, no, it can’t, and the Arbitrator agreed with us.

The fact is, RMA requires standardized language for AIPs to use in obtaining farmer certifications (see FCIC’s “Document and Supplemental Standards Handbook,” exhibit 2).  This language contains an obvious escape clause: “to the best of my knowledge and belief.”  If a farmer signs a certification in good faith, with a demonstrable basis of “knowledge and belief” that the information was correct – such as advice from his agent or AIP, a legitimate computer error, or some other factor —  then the farmer has NOT violated the certification on its face.

Here’s how the Arbitrator explained it in our case:

“[The AIP] argued that, even though it never requested [the farmer] report SBI information for [the distant owner] at the time it applied for coverage during the three years in dispute, FCIC crop insurance nevertheless is a ‘self-certification’ program and [the farmer] was required to report the information despite [the AIP’s] assurances that it was not necessary.

“This argument falls to facts on the record.  During the oral hearing, counsel for [the farmer] pointed to the text of the actual certification that [the farmer] was required to sign …. It says: ‘I certify that the information and answers on this application are correct to my knowledge and belief….’

“This ‘knowledge and belief’ certainly was informed by the advice [the farmer] had received from [the AIP] that the SBI information on [the distant owner] was not required, making the certification truthful and accurate on its face. There was no failure of ‘self certification’ by [the farmer].”

The lessons are clear.  For AIPs defending against a farmer claim, be very careful in relying on a farmer’s signature to an RMA “self-certification” standing alone to prove a case.  For farmers, if they can show “knowledge and belief” supporting their report, they have satisfied their duty of “self-certification” based on plain language as required by RMA.

OFW Law Wins Arbitration Decision Against Major Crop Insurance Company – Federal Agency Not Always Entitled to Deference in Interpretation of Its Rules

By Kenneth D. Ackerman and Elliot Belilos

OFW Law recently prevailed in Arbitration on behalf of a farm producer against a major insurance provider under USDA’s Federal crop insurance program.  The case hinged on whether a foreign individual with an ownership interest several layers removed from the insured held a “substantial beneficial interest” (“SBI”) as defined in USDA Risk Management Agency (RMA) rules.  OFW argued that the plain meaning of the term SBI, as consistently understood by the regulated community prior to this case, only required disclosure on the policy application of one tier of ownership above the farm itself.

OFW further argued that, even if the term SBI were ambiguous, the definition must be read in favor of the insured.  The insurance company had argued that the definition was ambiguous and RMA’s interpretation was entitled to deference by the Arbitrator.  Finally, OFW argued that the insurance provider made assurances to the ranch with respect to its eligibility to obtain crop insurance, and the insured reasonably relied on those assurances to its detriment.  The Arbitrator agreed with OFW on all three counts.

The issue arose when RMA, in a Compliance Finding, pronounced a new interpretation of SBI, requiring for the first time that an insured must report SBI information (SSN or EIN) on its insurance application of “embedded entities” – owners far removed but with greater than a ten percent ultimate interest in the insured.  The insurance company initially challenged that determination, but ultimately settled its dispute with RMA and declared the customer ineligible for indemnities.

Key to the insured customer’s victory was the Arbitrator’s reliance on the U.S. Supreme Court’s decision in Christopher v. SmithKline Beecham Corp.  In Christopher, the Court recognized that a Federal Agency is normally entitled to deference in the interpretation of its own regulations, but noted that an Agency is not to be afforded deference when the interpretation is inconsistent with prior Agency interpretations and is simply designed to fit conveniently a litigation position.  The Arbitrator ruled that RMA conveniently changed its interpretation of SBI to fit the facts in the case at hand.

A copy of the Arbitration decision (with the names of the parties and individuals involved changed) can be accessed here.

Consumers Union Testing Raises New Questions Re: Safety of Caramel Coloring

By Mark L. Itzkoff

In an article published January 23, 2014, Caramel Color: The health risk that may be in your soda, Consumer Reports (CR) announced the results of analytical tests conducted on 81 cans and bottles of 12 different soft drinks.  The soft drinks were purchased from stores in California and the New York metropolitan area, and were tested for the presence of 4-methylimidazole (4-MEI), a by-product that results from the production of certain caramel colorings.

4-MEI is formed when ammonia is used in the production of caramel coloring, as well as during the roasting of coffee beans and when meats are roasted or grilled.  There are four types of caramel coloring used in food processing, classes I, II, III and IV.  Only Caramel III and Caramel IV are produced using ammonia. (For more information, see FDA, Questions and Answers on Caramel Coloring and 4-MEI.)

In 2011, California designated 4-MEI to be a “substance know to the State of California to cause cancer” under The Safe Drinking Water and Toxic Enforcement Act of 1986 (Prop 65).  Under Prop 65, companies with 10 or more employees are prohibited from supplying any product containing a “known” carcinogen, unless the company provides consumers with a “clear and reasonable warning.”  Products are exempt from the warning requirements if the product poses no significant risk to consumers.  California has established a no significant risk level for 4-MEI of 29 micrograms (µg) per day.  The Prop 65 warning requirements do not apply to products sold outside of California.

Several of the soft drinks purchased by CR in California contained more than 29 µg of 4-MEI per twelve ounce serving.  While CR says that it “cannot say that this violates California’s Prop 65, we believe that these levels are too high and have asked the California Attorney General to investigate.”   It is important to note that if the Attorney General decides not to proceed with enforcement actions, Prop 65 enforcement actions still may be pursued by either local officials (e.g., city or county attorneys) or by private individuals (e.g., plaintiffs’ bar).

CR is also petitioning the Food and Drug Administration (FDA) to “set a federal standard for 4-MEI,” and to specify the type of caramel color used in the product’s ingredient list.  According to the CR article:

FDA said it does not believe that 4-MeI from caramel color at levels currently in food pose a risk. However, they appreciated Consumer Reports’ tests and are currently doing their own tests of foods, including sodas, for 4-MEI. They are also reviewing new safety data on 4-MEI to determine what, if any, regulatory action needs to be taken.

For additional information, see our December 11, 2011, memorandum, California Court Rejects Attempt to Overturn Proposition 65 Listing for Caramel Coloring Ingredient.

Wheat: The Staff of Life

By Marshall L. Matz with Molly O’Connor, as published in Agri-Pulse

When the subject of agriculture comes up, the focus usually starts with corn. It is the price of corn or the genetic modification of corn, ethanol (food vs. fuel), trade or the regulatory process here in the United States and its synchronization with other countries.  Just last month, the US-China trade talks centered on China’s arbitrary rejection of U.S. corn.  The agriculture conversation may then expand to include soybeans, cotton or animal agriculture. Rarely, however, does the conversation include wheat.  Have you noticed?

Wheat remains both the most overlooked commodity produced in the U.S. and, at the same time, the staff of life.

The United States is a major wheat-producing country, exceeded only by China, the European Union, and India.  Wheat ranks third among U.S. field crops in both planted acreage and gross farm receipts, behind corn and soybeans. The total value of the wheat crop in 2012 was approximately $18 billion, most of which was winter wheat. In fiscal 2012, total U.S. agricultural exports reached $135.8 billion, supporting 1 million jobs for U.S. farmers and ranchers.  The U.S. is consistently the world’s largest wheat exporter, exporting almost half of the U.S. wheat crop. In 2010, wheat exports contributed $5.9 billion to the U.S. economy.  We are, literally, the world’s breadbasket.

Wheat is the principal grain produced for human consumption in the United States, grown in 42 states. In the 1990s and the first decade of the 2000s, world wheat consumption continued to expand in response to rising incomes and the expanding world population.

Wheat accounts for 20 percent of all the calories consumed worldwide, according to the Food and Agriculture Organization. While there are more than 50,000 edible plants, most of the human population lives on a diet of wheat, rice and maize, along with roots and tubers (including cassava), soybeans, sorghum and animal products.  The relative importance changes with geography.  “In Africa, wheat is most important in Ethiopia, Kenya, Tanzania and Rwanda and seed research is being conducted in Ethiopia,” said Dr. Joe DeVries with the Alliance for a Green Revolution in Africa.  In 2011, wheat comprised 46 percent of all U.S. food aid donations; worldwide food aid donations were 40 percent wheat.

Our major wheat producing states tend to be Kansas, North Dakota, Montana, Oklahoma, Washington and South Dakota.  Each of these states produces over 100,000,000 bushels, averaging 47 bushels per acre.  We produce all 6 classes of wheat and can export all 6, making us a unique and reliable supplier.

Over 160,000 farms in the United States produce wheat with a total production of 2.2 billion bushels. The National Association of Wheat Growers serves as the national advocacy organization for wheat farmers composed of 22 different state wheat grower associations.

Wheat is essentially a grass that can be traced back to the cradle of civilization.  Within the U.S., wheat was first planted in 1777 and one of the first Americans to plant wheat was George Washington.   Disappointed by the returns he was getting on tobacco, Washington experimented with different cereal grains, and then selected wheat as his major cash crop.

The Dietary Guidelines for Americans urges all Americans to “Consume 3 or more ounce-equivalents of whole grain products, per day with the rest of the recommended grains coming from enriched or whole-grain products.  In general, at least half of the grains should come from whole grains.”  Unfortunately, as was noted recently by Dr. Joanne Slavin on behalf of the Grain Chain, only 12 percent of grain consumption is currently in the form of whole grains. So, we have a ways to go in this area.

Is wheat the staff of life? The facts are compelling.   Research into, and commercialization of, new and improved varieties of wheat must continue, in the spirit of Dr. Norman Borlaug and Edgar McFadden of South Dakota State University. (McFadden developed Hope Wheat which gave Dr. Borlaug the basis for his historic research and the Green Revolution.) Later this month, the Borlaug Summit on Wheat for Food Security will be held in Mexico; in the fall, SDSU will host the inaugural McFadden Symposium. It would be very helpful if Congress considered forming a Wheat Caucus to focus on wheat research, trade and other issues that are important to the production and promotion of wheat.

Historically, the amount of funding dedicated to wheat research has been dwarfed by the funding dedicated to the other major crops.  Increasing public and private research in wheat is important to sustaining a world population expected to reach 9 billion by 2050.

Mark Gaede, a long time Farm Hand on the Potomac at the National Association of Wheat Growers passed away on Christmas Eve at 60.  He is fondly remembered, and will be missed.

Marshall Matz was formerly Counsel to the Senate Committee on Agriculture, Nutrition and Forestry, and founded the World Food Program—USA. Matz specializes in food and agriculture at OFW Law. mmatz@ofwlaw.com.  Molly O’Connor is a Government Affairs Advisor at OFW Law.

National Commission on Hunger

By Marshall L. Matz

As a part of the 2014 Appropriations Bill, the Congress has created a National Commission on Hunger.   Section 743 of the new Bill establishes a National Commission on Hunger composed of ten (10) members to advise Congress and the Agriculture Secretary on: 1. How to “more effectively use existing programs and funds” to combat domestic hunger and 2. Develop “innovative public-private partnerships.”

The amendment was sponsored by Rep. Frank Wolf (R-VA), who is retiring and has been committed to domestic and international hunger issues during his career.   In a press release, Mr. Wolf said, “I believe it’s important for the government to continue to provide a safety net for those who fall on hard times, but the simple reality is that until we fully address our nation’s exploding debt and deficit, further cuts to discretionary spending – like food stamps – are all but inevitable.  My goal is for the commission to develop ways to decrease the number of hungry Americans using every resource available.”

The Act also appropriates $1,000,000 for the Secretary to enter into an agreement with an independent, private sector entity, through a competitive bid process, to conduct an assessment of existing and prospective domestic hunger and food insecurity.  The selected contractor would also provide technical expertise to the Commission.

The Commission shall be composed of 10 members, of whom—

  • 3 members shall be appointed by the Speaker of the House of Representatives;
  • 2 members shall be appointed by the minority leader of the House of Representatives;
  • 3 members shall be appointed by the majority leader of the Senate; and
  • 2 members shall be appointed by the minority leader of the Senate.

The statute does not specify what criteria should be used in selecting the Commission members so it is difficult to predict the agenda or where it will go. The legislative history of the Commission indicates its goal is to reduce federal costs and use existing funds “more effectively,” but there are no restraints on the recommendations of the Commission.

In past years, two other panels without legislative power had great influence on the nutrition agenda. In 1969, at the White House Conference on Food, Nutrition and Health, President Nixon declared hunger and malnutrition to be a federal responsibility.  From 1968 to 1977, Senator George McGovern Chaired the Senate Select Committee on Nutrition.  With  his friend and soul mate, Senator Bob Dole they championed a series of bill to expand and strengthen federal nutrition programs.

It would be wonderful if the Commission identified ways to improve the current nutrition programs.  A few ideas come to mind:

  • All of the programs would benefit from stronger nutrition education components and greater coordination.  Brochures don’t work.  How about computers in the schools and grocery stores that allow you to identify a food, find out the calories and then learn what you must do to burn off the calories?  (Some have ventured into this.)
  • In the SNAP (food stamp program), the biggest issue is whether to limit the foods that can be selected to help fight obesity.  Perhaps the Commission could devise a way to feature fruits, vegetable, whole grains and skim milk without taking away the right to choose the foods a recipient prefers.  SNAP recipients have the right to make a bad decision, but lets help to stack the deck.
  • The school meal programs may be the most in need of reform and efficiency.  Currently all 100,000 schools in the program must collect and verify income, even though the IRS and the States have that information.  Direct certification helps, but the problem is still very time consuming and expensive.  Further, the school food service authority pays 100% of the cost for data collection even though many programs in the school use the data.  The cost should be shared by all programs using the information bringing down the cost of a school lunch.
  • Also at school, the revenue from the vending machines should be split with the school meals program; and strong regulations are needed to make sure school food authorities are not paying for any costs except those need to produce the meal.

Hopefully, the Commission will not have another debate over the value of the USDA commodity program or digress into food safety areas, or other regulatory areas under the jurisdiction of FDA or USDA.

The Commission is only charged with providing policy recommendations to the Congress and the Secretary but it has an amazing opportunity to chart the course for the next generation.  Let’s hope this opportunity is not wasted on distractions.

Please contact Eden Shiferaw with any questions, eshiferaw@ofwlaw.com.

Dietary Supplements: New Online Method Now Available for Reporting Serious Adverse Events

By Michael J. O’Flaherty

Industry may now use a new form, accessible on the Department of Health and Human Services’ (HHS) Safety Reporting Portal, to satisfy requirements for reporting to HHS (including FDA and the National Institutes of Health) any serious adverse event associated with U.S. use of a dietary supplement.

Under the 2006 Dietary Supplement and Nonprescription Drug Consumer Protection Act, establishing section 761 of the FD&C Act, the manufacturer, packer, or distributor of a dietary supplement, whose name appears on the label, is required to report any serious adverse event associated with use of a dietary supplement product in the U.S.  See generally Guidance for Industry: Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (last revised Sept. 2013).

FDA encourages physicians, in particular, to file voluntary reports when their patients have experienced adverse events associated with dietary supplements.

FDA is continuing  to accept submission of MedWatch paper reports on Form FDA 3500A (for mandatory reporting) and Form FDA 3500 (for voluntary reporting), but encourages use of the new form.  Thus, the online system is available for both mandatory and voluntary reporting of adverse events.  Those who submit online reports may use either the system’s non-registered (“Guest”) or “Registered” accounts.

The use of a registered account, however, provides specific conveniences, including:

  • Saving partially completed reports;
  • Pre-populating certain information  into new reports; and
  • Reviewing one’s reporting history online.

Implementation of the secure online capability is intended to advance efficiency and convenience interests for the dietary supplement industry (i.e., manufacturers, packers, and distributors), as well as informational interests of the public at large.

2013 Voluntary National Retail Food Regulatory Program Standards Are Published by FDA

By Michael J. O’Flaherty

FDA earlier this month published the 2013 Voluntary National Retail Food Regulatory Program Standards, as well as a listing of the jurisdictions enrolled in the program.  The Retail Program Standards are intended to help reduce foodborne illnesses associated with retail food and foodservice establishments by promoting continuous improvement of food safety inspection programs.

The Retail Program Standards serve as a guide for retail food managers in state, local, tribal, and territorial retail food regulatory agencies.  Specifically, the standards are intended to promote:

  • Adoption of science-based model regulations (e.g., the FDA Food Code);
  • Improvements in staff training and increased program resources;
  • Implementation of risk-based inspection programs based on Hazard Analysis and Critical Control Point (HACCP) principles;
  • Development and implementation of outbreak and food defense surveillance and response plans; and
  • Enhanced communication and collaboration with industry and consumers.

The 2013 edition of the Retail Program Standards incorporates changes meant to improve the presentation and usability of the documents, including:

  • Addition of an administrative procedures document to more clearly explain the process for enrolling in the Retail Program Standards and maintaining enrollment;
  • Addition of criteria for enrolled jurisdictions to implement a targeted intervention strategy to reduce the occurrence of foodborne illness risk factors, and assess the effectiveness of the targeted intervention strategy;
  • Conversion of the FDA National Registry Report form (Form FDA 3519) and the Permission to Publish in National Registry form (Form FDA 3520) to PDF format to enable electronic completion and submission via email;
  • Conversion of forms and worksheets to PDF format to enable electronic completion; and
  • Revisions to the FDA’s Retail Program Standards website so that all forms and worksheets can be accessed and downloaded online.

As the science of food safety evolves, FDA works closely with stakeholders through the Conference for Food Protection to periodically review and update the Retail Program Standards.

Changes to FDA’s Regulation of Acidified and Low-Acid Canned Foods Are on the Horizon

By Michael J. O’Flaherty

A draft guidance document, recently published by FDA for public comment, describes changes being contemplated for the procedures that manufacturers of acidified foods and low-acid canned foods prospectively will use to submit information about the processes they use to ensure that the foods they produce are safe for consumers.  The draft guidance addresses:

  • Administrative procedures for submitting registration and process filing information required under 21 C.F.R. §§ 108.25(c) and 108.35(c);
  • Administrative procedures for voluntary registration and processing filing for certain foods that are not subject to registration and filing requirements under these regulations; and
  • A voluntary process whereby, upon request, FDA would review data and other information that support the establishment of a scheduled process for a new processing method or new equipment.

As part of this planned modernization, FDA would stop using Form FDA 2541a and Form FDA 2541c to collect processing information from manufacturers, and begin using forms that are specific to different industry manufacturing processes.  In the future, acidified and low-acid canned food manufacturers likely will be able to submit one or more of the process filing forms listed below, depending on the processing methods being used:

  • Form 2541d – Food Process Filing for Low-Acid Retorted Method
  • Form 2541e – Food Process Filing for Acidified Method
  • Form 2541f – Food Process Filing for Water Activity/Formulation Control Method
  • Form 2541g – Food Process Filing for Low-Acid Aseptic Systems

The new forms would be available in paper and electronic (which mirror the paper) formats.  The new forms are intended to be easier to use and to reduce confusion about the type of information FDA needs from a manufacturer to evaluate the adequacy of its processes.  This, in turn, reportedly would enable FDA to better ensure the safety of acidified and low-acid canned foods.

Before FDA begins using the new forms, stakeholders reportedly will have two opportunities to comment on them.

  • First, on specific topics relevant to the collection of information in the forms; and
  • Second, at a future date, more broadly on the content of the forms and how the forms would best be integrated into the process for submitting information about subject manufacturing processes, as required by 21 C.F.R. § 108.25 and 108.35.

Until the information in the draft guidance is finalized and the new forms are made available for use officially, manufacturers of acidified and low-acid canned foods must continue to submit establishment registrations and process filings using the procedures, forms, and guidance that are currently in effect.