GHY Tradelines

(Stanley Lubman – WSJ)

If a diner in the U.S. consumes a lunch of tilapia, mushrooms and spinach, there’s a decent chance the entire meal was imported from China. And the overwhelming odds are that none of those foods were inspected by the Food and Drug Administration when they arrived in the U.S.

This week’s revelation that nearly half the rice sold in the southern Chinese city of Guangzhou was found to be tainted with cadmium is just the latest in a long string of eye-catching stories that illustrate the dangers of eating in China. But lost in the exhaustive media coverage of the polluted foods that find their way on to Chinese tables are serious questions about what happens — or doesn’t happen — when Chinese food products make their way into the U.S.

Chinese food product imports to the U.S. are continuing to rise, but inspections in both China and the U.S. aren’t keeping pace, posing a growing danger to consumers. Many of the imports are used by restaurants, institutions and food processors; as a result, consumers see no labels, keeping them unaware of the origins of what they’re ingesting. Read more here.
 

(Dan Flynn – Food Safety News)

You, the consumer, are at the end of a long line of stops food makes before reaching your plate. Being able to trace this food back to its origins can be crucial to government and industry during a food-related recall or outbreak. But you may also want to know whether what you are about to consume is organic, whether it’s vegetarian, or maybe because of your beliefs you are looking for food that’s kosher or halal.

So while food companies might benefit from traceability and government may eventually demand it, food chain traceability is in large part about building relationships with consumers and giving them what they really want – the ability to trust that they know what they are eating.

Knowing what’s in your food and where it comes from sounds simple enough, but food chain traceability is a complex worldwide issue. It requires consistent standards and adequate technology in an ever changing world. Read more here.
 

(AFP)

US trade representative says it can agree that food security is a valid issue to be dealt with under the WTO talks

The US on Tuesday gave some ground on the contentious issue of food security in world trade talks in hopes of gaining at least some progress toward a limited new World Trade Organization (WTO) pact this year.

The US trade representative, which has been pressing for freer trade in food in hopes of boosting US exports, said it could agree that food security is a valid issue to be dealt with under the WTO talks.

The issue, which had put especially the US and India at loggerheads, has threatened to stymie the negotiations toward even a limited new WTO pact targeted for December’s WTO ministerial meeting in Bali. Read more here.
 

(Larry Dworkin – Packaging Digest)

The global demand for food safety from consumers, governments and food retailers has put unprecedented scrutiny on the international food supply chain.

As packaging is a key component, the IFS PACsecure food safety standard for individual packaging materials is being rolled out globally as companies from the U.S., Canada, Brazil, Chile and Europe are being trained and audited to its criteria. The standard is also expected to receive recognition from the Paris-based Global Food Safety Initiative (GFSI) by the end of spring.

Developed by PAC-The Packaging Assn., in conjunction with IFS Management GmbH, more than 70 U.S. and Canadian firms recently completed a one-day training course to help them to become compliant with the standard. Several have already been audited to its requirements and their names are being submitted to the GFSI as part of the benchmarking process. Read more here.
 

(Food Poisoning Bulletin)

During a budget hearing before a House subcommittee Friday, FDA Commissioner Dr. Margaret Hamburg said that food inspections were just one of many activities that will comprise the agency’s strategy to protect the nation’s food supply in the next budget cycle. But one element that she described as being “very, very important to our program” will give some in the food safety world pause: third party audits.

The U.S. Food and Drug Administration (FDA) uses third party audits of food manufacturing facilities and farms to supplement the inspections it performs. But, as two high-profile food poisoning outbreaks have illustrated, there are serious problems with the way the third-party inspection system works. Read more here.
 

(Liz Szabo – USA Today)

The Food and Drug Administration will conduct fewer food safety inspections this year because of the government sequester, commissioner Margaret Hamburg said Wednesday in an exclusive interview with USA TODAY.

While consumers may not feel the impact immediately, the loss of $209 million from its budget will force the agency to conduct about 2,100 fewer inspections, an 18% decline compared to last year.  The funding loss, part of the $85 billion in automatic budget cuts that took effect March 1, will also delay the agency’s implementation of the 2011 Food Safety Modernization Act, Hamburg said in an interview with the USA TODAY Editorial Board. Read more here.
 

(STR Trade Report)

The Food and Drug Administration has extended through Sept. 16 the period for public comments on two proposed rules issued in January under the Food Safety Modernization Act.

The first rule would establish science-based minimum standards for the safe growing, harvesting, packing and holding of fruits and vegetables grown for human consumption. The second rule would apply to human food and require domestic and foreign facilities that are required to register under the Federal Food, Drug and Cosmetic Act to have written plans that identify hazards, specify the steps that will be put in place to minimize or prevent those hazards, monitor results, and act to correct problems that arise.

The FDA states that these are the first of five proposed rules that, once finalized, will establish the foundation of, and central framework for, the modern food safety system envisioned by Congress in the Food Safety Modernization Act. The other three proposed rules on preventive controls for animal food, the Foreign Supplier Verification Program and accreditation of third-party auditors are under review.
 

(Karen Gullo – Bloomberg)

The U.S. Food and Drug Administration is violating food-safety law by delaying regulations intended to help prevent outbreaks of food-borne illnesses, a federal judge ruled.

U.S. District Judge Phyllis Hamilton in Oakland, California, said the agency has “admittedly failed to comply with the mandatory rule-making schedule” of the Food Safety and Modernization Act, signed into law by President Barack Obama in January 2011. The FDA had 18 months to issue new regulations. The agency said the “aggressive timelines” have “proven to be unachievable,” Hamilton said in a ruling. Read more here.
 

(Toni Clarke – Reuters)

The head of the U.S. Food and Drug Administration asked Congress for more money on Thursday to improve food safety, police imports and develop countermeasures against chemical and biological threats.

FDA Commissioner Margaret Hamburg told a Senate appropriations subcommittee that the agency is doing its best to tighten its belt by cutting back on travel and training. She said mandatory federal spending cuts known as sequestration will cut funds to the agency by $209 million.

The FDA gets part of its funding from taxpayers, but most comes from user fees agreed to and paid by drug companies to speed the review and potential approval of new products. Read more here.
 

(Sylvain Charlebois – Globe & Mail)

Cuts are looming again at the Canadian Food Inspection Agency (CFIA). The federal food safety regulator is facing cuts exceeding 15%, and many employees may lose their jobs over the next three years. At first glance, these cuts may seem extreme, but it appears that Canada is following a global trend of doing less with less in food safety risk management.

Most Canadian consumers are not aware that the federal government spends almost $400-million annually on food safety annually, a higher amount, per capita, than most other industrialized nations. The CFIA now employs more than 7,000 people. As a result of subsequent food safety crises we experienced over the last decade, such as mad cow in 2003, listeria in 2008, and most recently with XL Foods in 2012, our food safety surveillance costs have increased substantially. This all happened without having a full understanding of how efficient our food safety systems were. We simply do not know what the financial threshold is in terms of managing risks across the food industry in Canada. Before investing more, we should know how much we need to spend before making more changes. Read more here.
 

(STR Trade Report)

The Food and Drug Administration has made available for public comment a draft compliance policy guide on food facility registration. This draft is intended to provide guidance for FDA staff on enforcement of the food facility registration requirements of section 415 of the Federal Food, Drug and Cosmetic Act and also contains information that may be useful to the regulated industry and the public. Comments should be submitted no later than May 6 to be considered as the FDA begins work on the final version of the guide.

Section 415 of the FD&C Act requires owners, operators or agents in charge of domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the U.S. to register their facilities with the FDA. The Food Safety Modernization Act amended section 415 to require registrants for food facilities to submit additional registration information and renew such registrations biennially. FSMA also amended section 415 to provide that if the FDA determines that food manufactured, processed, packed, received or held by a registered facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals it FDA may suspend the registration of a facility that (1) created, caused or was otherwise responsible for such reasonable probability or (2) knew of, or had reason to know of, such reasonable probability and packed, received or held such food.
 

(STR Trade Report)

The Food and Drug Administration is accepting through April 26 comments on the proposed extension of information collections associated with the registration of food facilities.

Domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the U.S. must register with FDA. Facilities are also required to submit updates within 60 days of a change to any required information on their registration forms and to cancel their registrations when they cease to operate, are sold to new owners, or cease to manufacture, process, pack or hold food for consumption in the U.S.

Domestic facilities are required to register whether or not food from the facility enters interstate commerce. Foreign facilities that manufacture, process, pack or hold food are also required to register unless food from that facility undergoes further processing (including packaging) by another foreign facility before it is exported to the U.S. However, if the subsequent foreign facility performs only a minimal activity, such as putting on a label, both facilities are required to register.

Registration is accomplished using form FDA 3537, which refers to both the paper version of the form and the electronic system known as the Food Facility Registration Module. Information required on the registration form includes the name and full address of the facility; emergency contact information; all trade names the facility uses; applicable food product categories; and a certification statement that includes the name of the individual authorized to submit the registration form. Facilities are also encouraged to submit their preferred mailing address; type of activity conducted at the facility; type of storage, if the facility is primarily a holding facility; and approximate dates of operation if the facility’s business is seasonal.

The Food Safety Modernization Act requires registrants for food facilities to submit additional information and renew their registrations biennially. When determined necessary by FDA through guidance a food facility is also required to submit information about the general food category of a food manufactured, processed, packed or held at such facility.
 

(STR Trade Report)

The Food and Drug Administration has made available a plan that provides a strategic framework for its efforts to expand the technical, scientific and regulatory food safety capacity of foreign governments and their respective food industries in countries that export foods to the U.S. The FDA states that this plan meets the requirements of Section 305 of the Food Safety Modernization Act and does so by incorporating FSMA’s principles of comprehensive prevention, risk-based resource allocation and partnering. Among other things, the FDA will use enhanced intelligence of food safety risks on a country-by-country, commodity-by-commodity basis to determine the best candidates for technical assistance and capacity-building programs.

According to the FDA, the key goals and objectives of this plan are as follows.

- ensure efficiency across the FDA Foods and Veterinary Medicine Program, including by maximizing coordination within the agency

- increase effectiveness through evidence-based decision making by enhancing intelligence regarding food safety risks and utilizing food safety assessments

- support the exchange of information between the FDA and foreign government agencies or other entities by exploring the appropriateness of relying on mutual recognition of inspection reports, establishing new or identifying existing mechanisms to support secure electronic data sharing, and supporting bilateral or multilateral agreements that provide for the responsibility of exporting countries to ensure food safety

- enhance technical assistance and capacity-building by developing and delivering food safety training programs focused on best practices and global food safety principles, training foreign governments and food producers on U.S. requirements for safe food, and supporting provisions for the multilateral acceptance of laboratory methods and testing and detection techniques.
 

(The Canadian Press)

The federal government has launched a review of the E. coli outbreak last fall that sickened 18 people and led to the largest beef recall in Canadian history.

The review is to focus on what contributed to the outbreak of the potentially deadly bacteria at the XL Foods Inc. plant in Brooks, Alta. It will also look at how well the Canadian Food Inspection Agency performed, including why tainted meat was distributed to retailers and sold to consumers.

Agriculture Canada said the review will be conducted by an independent panel of experts who are to hand in a report with recommendations to improve food safety.

“We take the safety of Canada’s food supply very seriously and we remain committed to the continuous improvement of Canada’s strong food safety systems,” Agriculture Minister Gerry Ritz said in a news release Friday evening. Read more here.
 

(STR Trade Report)

The Food and Drug Administration has adopted without change a May 2011 interim final rule concerning administrative detentions of potentially adulterated or misbranded human or animal food. As specified by the Food Safety Modernization Act, this rule allows the FDA to order administrative detention of any article of food that is found during an inspection, examination or investigation if it has reason to believe that the article of food is adulterated or misbranded. Previously the FDA was only able to order such detentions if it found credible evidence or information indicating that the article of food presented a threat of serious adverse health consequences or death to humans or animals.

The FDA believes this authority will further help it to prevent potentially harmful food from reaching U.S. consumers. The agency noted in the interim final rule that it had never administratively detained an article of food despite having the authority to do so but that under the new criteria it is more likely to use administrative detention in situations where it might previously not have; e.g., where the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

In response to comments on the interim final rule the FDA has provided the following information.

• Decisions on whether the FDA has “reason to believe that an article of human or animal food is adulterated or misbranded” are fact-specific and will therefore be made on a case-by-case basis.

• The FDA will continue to use its advisory action tools, such as warning letters and untitled letters, to achieve voluntary compliance and voluntary corrective action to address adulteration or misbranding violations, as appropriate.

• Given the procedural and substantive differences between administrative detention and detention that occurs during import admissibility review, confusion between the two is unlikely; however, when the FDA gives written notice in either circumstance it will make clear which type of detention is involved.

• The FDA intends to issue notice of termination of administrative detention on the same day the decision is made whenever practicable. If the FDA fails to issue a termination notice and the detention period expires (a maximum of 30 days from the date the detention was ordered) the detention is deemed to be terminated.

• The responsibility for paying the storage costs of administratively detained food is a matter to be resolved between the private parties involved. An owner, operator or agent in charge of the place where the food is located can request modification of a detention order to allow the food to be moved or destroyed if they do not want to store it.
 

(STR Trade Report)

All foreign and domestic companies and facilities that manufacture, pack or store food, alcoholic beverages, food ingredients, pet foods or dietary supplements must renew their food facility registrations with the Food and Drug Administration before Jan. 31, 2013, or risk suspension by the FDA. If suspended, a facility will not be allowed to import, distribute or sell food in the United States. All facilities covered by the law must re-register by the deadline.

The registration is required under Section 102 of the Food Safety Modernization Act. This law also requires that the facility designate a U.S. agent. The U.S. government has made it clear that it will enforce the re-registration requirement and that those acting as U.S. agent could be financially responsible for the cost of facility inspections.

To find out more about your company’s risk and how you can quickly and easily meet the new re-registration requirements, visit the FDA Solutions Group Web site.
 

On January 4, 2013, the U.S. FDA published new food safety regulations, totalling nearly 1300 pages. The regulations include the generic hazard analysis and preventive controls for all products covered by the Food Safety Modernization Act with the exception of fresh produce and the new requirements for preventive controls for fresh produce. Compliance to the regulations will be required by exporters of food to the U.S. as well as U.S. domestic food manufacturers.

These regulations are two (2) of the four (4) regulations that were drafted by the U.S. FDA in response to the signing of the Food Safety Modernization Act by President Obama January 4, 2012. The two remaining are the regulations concerning  the Foreign Supplier Verification Program/Voluntary Qualified Importer Program and that covering third party audits. Publishing of these regulations is anticipated in the near future.

Below are the links to the respective regulations:

Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food

Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
 

(China Daily – Jin Zhu)

China will continue to strengthen its supervision of food safety and make greater efforts to crack down on quality failures, said Zhi Shuping, director of the General Administration of Quality Supervision, Inspection and Quarantine, the country’s top quality watchdog.

In 2012, the administration seized substandard products valued at 6.13 billion yuan ($985 million) in 20,000 food safety cases, according to the administration’s annual working conference on Jan 8.

The administration also launched overall quality tests on 3,421 batches of imported dairy products last year, which covered “almost every brand and variety imported into China”, it said.

Meanwhile, the safety rate of the country’s food exports reached 99.9 percent last year, according to the administration. Read more here.
 

(Voice of America – Steve Baragona)

New rules hailed as the biggest improvements in U.S. food safety since the 1930s took a step forward Friday. Regulators say the proposals may prevent more than one million cases of foodborne illness each year.

They come two years to the day since President Barack Obama signed the Food Safety Modernization Act. They are the first step in implementing that law, which puts the Food and Drug Administration [FDA] in charge of preventing foodborne disease outbreaks. Experts say that’s a change from the reactive role it has played in the past.

Passage of the law followed a string of high-profile nationwide disease outbreaks linked to bagged spinach, peanut butter and other foods, in which hundreds of people became ill.

“They occurred because of problems that would have been addressed by these kinds of approaches. So I think we’re very optimistic that we’ll begin to see real change,” said FDA Commissioner Margaret Hamburg. Read more here.
 

The U.S. Food and Drug Administration (FDA) had previously set a Dec. 31 deadline for facilities that manufacture, process, pack or hold food for human or animal consumption to register or renew their existing registrations, which must be done every other year. However, FDA is now extending that deadline for a month in light of delays in this year’s registration process and the substantive changes to this process that were included in the Food Safety Modernization Act.

Specifically, FDA intends to exercise until Jan. 31 enforcement discretion with respect to registration renewals submitted after Dec. 31. As a result, FDA will not suspend the registration number for facilities that submit a registration or renewal during this one-month period. Nevertheless, the agency is encouraging facilities to renew their registrations as early as possible.

FDA has also issued two new guidance documents to further assist facilities that must comply with this registration requirement. “What You Need to Know About the Registration of Food Facilities – Small Entity Compliance Guide” contains information regarding who is required to register and who may be exempt, how often facilities must register and renew registrations, when FDA may suspend a registration, and how facilities may submit their registrations and registration renewals to FDA. Among other things this guidance highlights the additional information that must be provided in a facility’s registration pursuant to the Food Safety Modernization Act, which includes the email address of the U.S. agent for the foreign facility and an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the Federal Food, Drug and Cosmetic Act. “Questions and Answers Regarding Food Facility Registration (Fifth Edition)” contains updated answers to questions regarding food facility registration that are based on the FSMA amendments.