Defending Food Safety : Food Safety Defense Lawyer & Attorney : National Food Industry Counsel : National Food Regulatory Lawyer and Attorney, FDA Lawyer and Attorney. USDA Lawyer and Attorney : Gass Weber Mullins Law Firm

The U.S. Food and Drug Administration (“FDA”) has released its annual report regarding the first year of operation of the Reportable Food Registry (“RFR”).

The RFR is an internet based portal for Registered Food Facilities to report potential problems with FDA-regulated food and feed products. Facilities that manufacture, process, pack, or hold food or feed must submit a report when there is a reasonable probability that a product will cause serious adverse health consequences to humans or animals.

The RFR was activated in September 2009 in accordance with the FDA Amendments Act of 2007 to: (1) provide a “reliable mechanism to track patterns of adulteration in food;” and (2) “to target [the FDA’s] limited inspection resources to protect the public health.”

Between September 2009 and September 2010, a total of 2,240 reportable food submissions were entered into the RFR. Of these 2,240 entries, 229 were primary reports, 1872 were subsequent reports as a result of a primary report; and 139 were amendments to previously submitted reports.

A primary report is an initial report concerning a reportable food from either industry or public health officials, while a subsequent report is a report submitted by either a supplier (upstream) or a recipient (downstream) of a food/feed (including ingredients) for which a primary report was submitted. FDA’s annual report succinctly lays out what contaminants and what types of food comprised the 229 primary reports. The pie graph below illustrates the seven food safety hazards found in the primary reports:

Sixteen (16) primary reports concerned Salmonella in spices and seasonings. The FDA reported that in response to this RFR finding, a national spice trade association is developing guidance to reduce the risk of pathogen contamination in spices. FDA also reported a second industry change driven by the RFR: one of the nation’s largest baking industry trade associations is enhancing its industry guidance on preventing unintended allergens from being introduced into bakery products.

Passage of the new Food Safety Modernization Act (“FSMA”) has also placed many new responsibilities on the FDA’s shoulders. The FSMA has increased the frequency of FDA inspections of all facilities, so whatever inspection capability is left over must be devoted to the most high-risk commodities.

Of the 229 primary reports, 226 were submitted by industry and just 3 were entered by federal and state regulatory officials.

It should be noted that 1,000 of the 1,872 subsequent reports were related to the massive recall of Hydrolyzed Vegetable Protein (“HVP”) in March 2010 due to Salmonella concerns. The manufacturer of the HVP notified its many customers of the situation and each customer then submitted a subsequent report.

The FDA annual report regarding the RFR stated that no illnesses related to the HVP recall were reported. Likewise, the report stated that no illnesses related to a separate recall for an undeclared allergen were reported. To date, it would appear that no serious health problems were reported in connection with any of the RFR reports.

The RFR also tracks data on reports concerning foods and ingredients from international sources. This first year showed that 53 of the 229 primary reports were caused by foods or ingredients from foreign sources, coming from at least 21 different countries. China caused 13 problems, the most, while Mexico took second place with 5 issues. Click on the following link to view a copy of the the FDA’s most recent RFR ANNUAL REPORT.

Moving forward, the RFR will continue to play a significant role in food safety regulation. Thus, contact our firm for additional information if you have any questions regarding how the RFR works, or the circumstances under which your own company may someday need to submit a report.
 

• Email This
• Print
• Comments
• Trackbacks
• Share Link

The FDA’s Reportable Food Registry (“RFR”) has now been up and running for a full year.  So, has the RFR been successful?

As we discussed previously, the RFR is an internet based portal through which food manufacturers must notify the FDA of food products that have a “reasonable probability” of causing health problems or death in humans or animals. The RFR applies to any food product regulated by the FDA, with the exception of infant formula and dietary supplements.

This summer, the FDA issued a report on the RFR’s first seven months of operation, September 2009 through March 2010. Click on the following link to view a copy of the THE 2009 - 2010 FDA RFR REPORT.

During the first seven months, food companies submitted 125 “primary reports” through the RFR. A primary report is an initial report concerning a reportable food from either industry or public health officials, such as federal, state, or local regulators. Of those 125 primary reports, 122 were from industry, and 3 were from regulatory officials.

Also during that initial period, 1,638 “subsequent reports” were submitted as a result of a primary report. A subsequent report is a report submitted by either a supplier (upstream) or a recipient (downstream) of a food/feed (including ingredients) for which a primary report was submitted.

The FDA classified the 125 primary reports into seven food safety hazard categories, as illustrated in the pie graph below:

Percent Distribution of 125 Primary RFR Entries by Food Safety Hazard

Because this initial reporting period was so brief, the FDA wisely cautions that inferences cannot be drawn from this data. Nevertheless, the figures are still interesting.

More meaningful, however, is that of the 125 reports, only one caused a health problem – “an allergic-type reaction” in four family members. The FDA pointed out that all the reports had the potential to bring harm. However you want to interpret the fact that there was only a single health problem, it cannot be lost among the other numbers. Perhaps it highlights how the RFR brings an abundance of caution that will only make our food supply even safer.

And a meaningful statement was made by the FDA’s Deputy Commissioner for Foods, Michael Taylor. When asked how industry reacted to the RFR, Taylor said “The industry is taking it very seriously. They know it is a legal duty.” We are in a period of consumer distrust. I would like to share with consumers that not only does industry take food safety regulation seriously, I have personally experienced food manufacturers setting their safety standards above and beyond their legal obligation. Although recent media may suggest otherwise, our food manufacturers, with the exception of a few, care deeply about safety.

After just one year, it is too soon to determine whether the RFR will meet its goals of tracking patterns of adulteration and targeting the FDA’s limited inspection resources. The FDA has labelled the RFR’s first seven months “a success story.” It was not a perfect first year – the electronic submission process was already overhauled once; and questions still remain – how many of the potentially hazardous situations would have been reported under regulation in place prior to the RFR?

In any event, we will continue, of course, to answer your questions about RFR compliance and monitor new RFR developments.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

The FDA's Reportable Food Registry (“RFR”) first went into effect in September 2009. Since then, we have been watching closely the application and enforcement of the RFR.

At its core, the RFR is an internet based portal which requires certain food companies to report the discovery of potential problems with food products. Generally speaking, under the RFR, a food company may have an obligation to inform the FDA – and file a report through the RFR website portal – if it learns that it has manufactured, received or distributed a "reportable food." In turn, a reportable food is defined generally as any food product that has a “reasonable probability” of causing health problems or death in humans or animals.

When the RFR portal was initially unveiled, the FDA issued draft guidelines to assist industry in complying with the new requirements. Nearly ten months later, with mixed reactions, the guidance has been revised: “Draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007”.

Notable changes include:

• Human food containing an undeclared major food allergen as defined in the Food Allergen Labeling and Consumer Protection Act (FALCPA) may be a reportable food.

• If a facility receives a bulk trailer shipment (and the driver leaves), but the shipment is rejected before it is off-loaded, the facility must still submit a report.

• A report pertaining to a food later determined by FDA not to be a reportable food will be purged from the RFR, but will remain in FDA’s records, subject to normal record retention requirements.

• A Registered Food Facility must submit a reportable food report even if the reportable food is intended solely for export.

• A foreign Registered Food Facility is not required to submit a reportable food report for a reportable food that is not shipped to the U.S.

The latest edition of the draft guidelines, however, also addresses some important additional issues brought to light by industry reaction to the initial draft.

For instance, although a food company is not required to report a problem if it was the sole manufacturer of a food product, it discovered the problem internally, and then corrected the problem before the food left its control, the previous guidelines did not specifically address what should happen when potentially reportable foods are shipped to different facilities within the same company.

Because food passes through many different hands from farm to fork, sometimes between facilities under the same corporate umbrella, industry experts expressed concern regarding the meaning of “transfer” in the exemption.

Now, the draft guidelines specify that an intra-company transfer in a vertically integrated company is not a “transfer to another person” under the RFR. Thus, a facility is not required to submit a reportable food report when:

• The adulteration originated with the responsible party; and
• The responsible party detected the adulteration prior to any transfer to another person (or, to another facility not owned or controlled by the company); and
• The responsible party:
  • Corrected the adulteration; or
  • Destroyed or caused the destruction of the food.

It is important to note, however, that the FDA still considers a food product to have been “transferred” when the food is shipped to a third-party warehouse, even if the responsible party maintains ownership and direct control over distribution of the specific product.

In any event, the FDA is seeking comments on Edition 2 of the draft guidance, and is specifically requesting feedback on the revised meaning of “transfer.” If your business is accountable to the RFR, take some time to review the guidelines. Click on the following link to download the FDA RFR Guidelines (2nd Ed.).

• Email This
• Print
• Comments
• Trackbacks
• Share Link

On March 14, 2009, President Obama announced the creation of the Food Safety Working Group. The group is currently chaired by Secretary of Health and Human Services Kathleen Sebelius and Secretary of Agriculture Tom Vilsack.

Appearing after the PCA peanut butter outbreak and recall, the Working Group was formed in response to an increasing number of foodborne illness outbreaks in recent years, and was tasked with the responsibility of recommending changes to food safety regulations, fostering better coordination between federal agencies, and ensuring the enhanced enforcement of numerous food safety laws.

In May 2009, the Working Group launched its website (foodsafetyworkinggroup.gov) and held a public “listening day” to solicit input from federal and state health officials, food industry, consumers and others. Then, four months following its creation, the Working Group announced its three core principles: (1) working to prevent harm to consumers as a first priority; (2) recognizing that effective food safety inspections and enforcement depend upon good data and analysis; (3) committing to quickly identify and stop foodborne illness outbreaks.

To facilitate these goals, the Working has Group assisted, in varying degrees, with the development of numerous food safety issues in the past year. Below are just a few of the initiatives recently encouraged and embraced by the group:

• FDA’s new rules to combat Salmonella contamination in eggs.

• FDA request for comments on proposed guidance to reduce microbial contamination of tomatoes, melons and leafy greens.

• USDA's new initiatives aimed at testing bench trim for E. coli O157:H7 and the issuance of draft guidelines on methods for controlling E. coli O157:H7 on the farm.

• The enhancement of www.FoodSafety.gov and content for consumers.

• The opening of the Commercial Targeting and Analysis Center to better ensure the safety of imported foods.

• FDA’s activation of the Reportable Food Registry designed to more quickly identify and track adulterated food products.

• The decisions by FSIS, FDA, and CDC to host joint food safety meetings for input and collaboration on performance measures for food safety.

• The recent decisions by USDA and FDA to conduct additional public meetings regarding product tracing and tracing source materials for E. coli O157:H7 in beef.

These, of course, represent many significant food safety initiatives made possible by substantial governmental and industry collaboration.  So, although the President announced during the creation of the Working Group that “[t]here are certain things [such as ensuring safe food] that only a government can do,"  we would simply note that his statements only paint a partial picture.

Let there be no mistake, Americans do enjoy one of the safest food supplies in the world in part because of continued governmental oversight. But, it is also important to note that American consumers enjoy one of the safest food supplies in the world in a much larger part because of the efforts of the hard-working Americans who actually feed our families. Thus, while government can regulate industry, only industry and its individual members can safety and successfully feed a nation.

So, is the Working Group still working? Of course. But, let us not forget that so are you. Thus, once again, we would like to say "thank you" to all those who work tirelessly, each and every day, to provide safe food for each of us and our families.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Since its launch in September 2009, we've been watching closely the application and enforcement of the FDA's Reportable Food Registry (“RFR”).

According to the FDA, the purpose of the RFR is to provide a “reliable mechanism to track patterns of adulteration,” and “to target the agency's limited inspection resources where they're needed most.”

The RFR, at its core, is an internet based portal which requires certain food companies to report the discovery of potential problems with food products. Generally speaking, under the RFR, a food company may have an obligation to inform the FDA – and file a report through the RFR website portal – if it learns that it has manufactured, received or distributed a "reportable food." In turn, a reportable food is defined generally as any food product that has a “reasonable probability” of causing health problems or death in humans or animals.

When the RFR portal was initially unveiled, the FDA issued draft guidelines to assist industry in complying with the new requirements. Nearly ten months later, with mixed reactions, the guidance has been revised: “Draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007”.

Notable changes include:

• Human food containing an undeclared major food allergen as defined in the Food Allergen Labeling and Consumer Protection Act (FALCPA) may be a reportable food.

• If a facility receives a bulk trailer shipment (and the driver leaves), but the shipment is rejected before it is off-loaded, the facility must still submit a report.

• A report pertaining to a food later determined by FDA not to be a reportable food will be purged from the RFR, but will remain in FDA’s records, subject to normal record retention requirements.

• A Registered Food Facility must submit a reportable food report even if the reportable food is intended solely for export.

• A foreign Registered Food Facility is not required to submit a reportable food report for a reportable food that is not shipped to the U.S.

The latest edition of the draft guidelines, however, also addresses some important additional issues brought to light by industry reaction to the initial draft.

For instance, although a food company is not required to report a problem if it was the sole manufacturer of a food product, it discovered the problem internally, and then corrected the problem before the food left its control, the previous guidelines did not specifically address what should happen when potentially reportable foods are shipped to different facilities within the same company.

Because food passes through many different hands from farm to fork, sometimes between facilities under the same corporate umbrella, industry experts expressed concern regarding the meaning of “transfer” in the exemption.

Now, the draft guidelines specify that an intra-company transfer in a vertically integrated company is not a “transfer to another person” under the RFR. Thus, a facility is not required to submit a reportable food report when:

• The adulteration originated with the responsible party; and
• The responsible party detected the adulteration prior to any transfer to another person (or, to another facility not owned or controlled by the company); and
• The responsible party:
  • Corrected the adulteration; or
  • Destroyed or caused the destruction of the food.

It is important to note, however, that the FDA still considers a food product to have been “transferred” when the food is shipped to a third-party warehouse, even if the responsible party maintains ownership and direct control over distribution of the specific product.

In any event, the FDA is seeking comments on Edition 2 of the draft guidance, and is specifically requesting feedback on the revised meaning of “transfer.” If your business is accountable to the RFR, take some time to review the guidelines. Click on the following link to download the FDA RFR Guidelines (2nd Ed.).  They're a good read.

Ultimately, sharing helpful perspective and feedback with FDA today could help mitigate downrange confusion and, perhaps, even save your company from appearing in the RFR in the future.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

The FDA's Reportable Food Registry ("RFR") first went online in September 2009.

Since its inception, numerous questions have been asked regarding the specific circumstances under which a food company is required to inform the FDA about a potentially dangerous food product.

Generally speaking, under the RFR, any food company may have an obligation to inform the FDA – and file a report through the RFR website portal – if the company learns that it has manufactured, received or distributed a potentially implicated food product.

Because the FDA reporting requirements are only triggered under certain defined circumstances, however, a food company uncertain about its reporting obligations under the registry should consider contacting legal counsel to determine the extent and scope of any potential reporting requirements triggered by the FDA rules.

In their current form, the FDA rules extend to any company that is required to submit registration information to the FDA as a manufacturer, processor, packer, or distributor of food. In turn, the rules apply to any food product regulated by the FDA, with the exception of infant formula and dietary supplements which are covered by other regulatory requirements.

Under existing FDA rules, a food company is required to alert the FDA – through the RFR Portal – within 24 hours of becoming aware it has sold and shipped a "reportable food." In turn, a reportable food is defined generally as any food product that has a “reasonable probability” of causing health problems or death in humans or animals. As explained by the FDA, some examples of reasons a food may become reportable include bacterial contamination, allergen mislabeling or elevated levels of certain chemical components.

In turn, once a food company discovers a problem with a product it has received, manufactured or shipped, and submits a report through the RFR, it will be required to cooperate with the FDA to help determine the cause and contain any potentially affected products. In addition, responsible parties will be required to notify their relevant suppliers, distributors and customers of any potential food safety issues, be ready to submit further data and analysis to the FDA, and initiate their own investigation if the problem is thought to have originated internally.

Notably, however, in addition to other exceptions, the FDA’s reporting requirements apply only to products that have been shipped into commerce. For this reason, a food company is not required to report a problem to the FDA if it was the sole manufacturer of the food product, it discovered the problem internally before the food product was distributed, and it then corrected the problem or destroyed the implicated food.

For additional information on the registry and reporting requirements, please visit www.fda.gov/ReportableFoodRegistry.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

The FDA's Reportable Food Registry ("RFR") first became active in September 2009. 

In 2007, former President Bush signed into law the Food and Drug Administration Amendments Act (Public Law 110-85). The Act, which amended the Federal Food, Drug and Cosmetic Act by creating a new section 417 (21 U.S.C. 350f), required the Secretary of Health and Human Services to establish a mandatory reporting registry for potentially dangerous foods. The stated purpose of the amendment was to provide FDA with “a reliable mechanism to track patterns of adulteration in food.” Implementation of the new law, however, was delayed while the FDA worked on developing an effective electronic reporting system.

Now that the Reportable Food Registry (“RFR”) is up and running, a food company may be required to alert the FDA (through the RFR Portal) within 24 hours of becoming aware it has received, sold or shipped a "reportable food." According to the FDA, a reportable food is defined as any food product that has a “reasonable probability” of causing health problems or death in humans or animals. 

Because reporting is only required under specific circumstances, however, any company uncertian about its reporting duties should seek legal advice to determine the extent and scope of any reporting requirements under the RFR.

For additional information on the registry and reporting obligations, please visit www.fda.gov/ReportableFoodRegistry.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

The FDA has announced a new tool it believes will help prevent future cases of food-borne illness – the Reportable Food Registry.

In 2007, former President Bush signed into law the Food and Drug Administration Amendments Act (Public Law 110-85). The Act, which amended the Federal Food, Drug and Cosmetic Act by creating a new section 417 (21 U.S.C. 350f), required the Secretary of Health and Human Services to establish a mandatory reporting registry for potentially dangerous foods. The stated purpose of the amendment was to provide FDA with “a reliable mechanism to track patterns of adulteration in food.” Implementation of the new law, however, was delayed while the FDA worked on developing an effective electronic reporting system.

Now that the Reportable Food Registry (“RFR”) is up and running, the mandatory reporting requirements have gone into effect. The new FDA rules apply to any company that is required to submit registration information to the FDA for a food facility “that manufactures, processes, packs, or holds food for human or animal consumption in the United States.” In turn, the rules extend to any food or animal feed regulated by the FDA, except for infant formula and dietary supplements which are covered by other regulatory requirements.

Under the new FDA rules, a food company is now required to alert the FDA – through the RFR Portal – within 24 hours of becoming aware it has sold and shipped a "reportable food." According to the FDA, a reportable food is defined as any food product that has a “reasonable probability” of causing health problems or death in humans or animals.

As explained by the FDA, some examples of reasons a food may be reportable include bacterial contamination, allergen mislabeling or elevated levels of certain chemical components.

In turn, once a food company discovers a problem with a product it has shipped, and submits a report through the RFR, it will be required to cooperate with the FDA to help determine the cause and prevent potential health problems. Companies will also be required to notify relevant suppliers and distributors of any potential safety issues, be ready to submit further data and tests to the FDA, and initiate their own investigation if the problem is thought to have originated internally.

Notably, however, the new reporting requirements apply only to products that have been shipped into commerce. For this reason, a food company is not required to report a problem to the FDA if it discovered the problem before a food product was shipped, and then corrected the problem or destroyed the food.

Although Michael Taylor (senior advisor to the FDA commissioner) stated that industry should be able to easily judge when a food product is “reportable” under the new guidelines, the Grocery Manufacturers Association quickly responded raising concerns over what it called “questions and ambiguities” in the registry. In turn, the GMA urged the FDA to remain flexible, and to help work through potential ambiguities, as the new regulations go into effect.

For additional information on the registry and reporting requirements, please visit www.fda.gov/ReportableFoodRegistry

• Email This
• Print
• Comments
• Trackbacks
• Share Link