GHY Tradelines

(Reuters – Rod Nickel)

U.S. country-of-origin meat-labeling rules have directly cost Canada’s hog and pork industry more than $2 billion, according to a report that could help determine retaliation against U.S. exports if Washington does not change its requirements.

The United States must bring the labeling rules, known by the acronym COOL, into compliance with a World Trade Organization ruling by May 23, 2013, according to a WTO decision released last month.

But citing no apparent movement by the U.S. Congress since the original WTO ruling in mid-2012, the Canadian Pork Council released an estimate of damages on Monday. The council called on Ottawa to impose retaliatory tariffs on imports from the United States if there is no change by the WTO deadline. Read more here.
 

(CBC News – David McKie)

Coalition wants plug pulled on meat pre-clearance pilot project in wake of XL Foods recall

An internal Foreign Affairs memo expressed concern that U.S. “confidence in the Canadian food safety system” could be undermined in the wake of last fall’s XL Foods beef recall.

Josée De Menezes, the department’s acting director of the Sanitary and Phytosanitary Measures Division, expressed that concern on Sept. 27 in a widely distributed departmental briefing note obtained under the Access to Information Act by CBC News Network’s Power & Politics.

Specifically, the note refers to a U.S. campaign to halt a meat pre-clearance pilot project that is part of the Canada-U.S. Beyond the Border initiative announced last year by Prime Minister Stephen Harper and U.S. President Barack Obama. The year-long pilot project was scheduled to begin in September, but CBC News has learned it has yet to get underway. Read more here.
 

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
 

(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.
 

(STR Trade Report)

Each foreign and domestic food facility must renew its food facility registration with the Food and Drug Administration before Dec. 31, 2012. The FDA may suspend the registration number of any facility that fails to comply, resulting in a prohibition on the importation, distribution or sale of food from the suspended facility. Food importers are urged to take immediate action to prevent import refusals or detentions come Jan. 1, 2013.

The 2002 Bioterrorism Act requires all facilities that manufacture, process, pack or hold food or beverages for consumption in the United States to register as a food facility with the FDA. Under the Food Safety Modernization Act enacted in 2011 those registrations must be updated before Dec. 31, 2012, and every two years thereafter. Facilities that fail to renew may have their registration number suspended.

Any doubts over the FDA’s intentions to exercise these suspension powers were dispelled last month when the agency suspended the registration of Sunland Inc., a producer of nuts and nut and seed spreads, after noting several deficiencies during a facility inspection. As a result of this suspension neither Sunland Inc. nor any other person can introduce into U.S. commerce, offer to import, or export any food made at the suspended facility. The warning was reiterated by Amy Barringer, a director in the FDA’s Office of Compliance, who asserted during a webcast sponsored by the United Fresh Produce Association that shipments may be refused if foreign food facilities do not submit their registration renewals by Dec. 31.
Read more »

(The Packer)

For the first time ever, the Food and Drug Administration in late November used its authority – granted by the Food Safety Modernization Act – to effectively shut down a company, citing major food safety infractions.

Portales, N.M.-based nut processor Sunland Inc., is prohibited from shipping product pending a series of corrective measures. The company’s peanut butter was linked to a multi-state outbreak of Salmonella Bredeney infections that sickened 42 people in 20 states.

The action drew praise from lawmakers and food safety advocates. Read more here.
 

(STR Trade Report)

The Food and Drug Administration announced this week the first-ever use of its authority under the Food Safety Modernization Act to suspend the registration of a food facility. The FDA issued a suspension order against a New Mexico facility of a producer of nuts and nut and seed spreads due to its history of violations as well as the fact that peanut butter made by this company has been linked to an outbreak of salmonella. As long as this order remains in effect no person can import or export food into or from the U.S. from this facility, offer to import or export food into or from the U.S. from this facility, or otherwise introduce food from this facility into interstate or intrastate commerce in the U.S.

Registration with the FDA is required for any domestic or foreign facility that manufactures, processes, packs or holds food for consumption in the U.S. Under FSMA all such facilities are required to renew their registration before the end of 2012 and to re-register every two years thereafter. This law also allows the FDA to suspend a facility’s registration when food manufactured, processed, packed, received or held by that facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals, and other conditions are met.

An FDA press release notes that the affected company will now have an opportunity to request an informal hearing on the actions required for the reinstatement of its facility’s registration. If the FDA subsequently determines that the suspension remains necessary it will require the company to submit a corrective action plan to address the immediate problems and to implement a sustainable solution to those problems in a sound scientific manner. The FDA will reinstate the facility’s registration only when it determines that the company has implemented procedures to produce safe products.
 

The U.S. FDA registration process for domestic facilities and foreign facilities exporting to the U.S. is now open, October 22, 2012.  Under the U.S. Food Safety Modernization Act (FSMA) domestic and foreign food facilities (including food storage facilities) are required to register with the U.S. FDA biennially (on even numbered years 2012, 2014, 2016 etc.). Initially announced October 1, 2011, the process of registration was delayed until today.

• Step by step instructions for on line registration

• Details and forms to register by fax or post

• General information about the registration process and requirements

Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the U.S. are required to register the facility with the FDA.

Foreign facilities that manufacture/process, pack, or hold food are required to register unless food from that facility undergoes further processing (including packaging) by another foreign facility before the food is exported to the United States. However, if the subsequent foreign facility performs only a minimal activity, such as putting on a label, both facilities are required to register.

Failure to register or renew a registration will result in products from a foreign facility being refused entry into the U.S.
 

(STR Trade Report)

The Food and Drug Administration has announced that the food facilities re-registration period under the Food Safety Modernization Act will open at 12:01 a.m. on Oct. 22. Facilities can register online, via mail or by fax, but the FDA encourages online registration. To assist with this process the FDA has made available an updated guidance document that is available here.

Under FSMA §102, all domestic and foreign facilities that manufacture, pack or store food, food ingredients, pet foods or dietary supplements are required to renew their registration with the FDA before the end of 2012 and to re-register every two years thereafter. This represents a change from the registration requirement for food facilities originally established in 2002 under the Bioterrorism Act. According to the FDA, the FSMA improves the registration process by ensuring that the agency has accurate contact information for each facility and including on the form new categories of foods that will help the FDA rapidly communicate with the right facilities in the event of an emergency.

Those affected by the new registration requirements are reminded that FSMA also imposes new burdens and potential liabilities on entities designated as U.S. agents to foreign food facilities. One of these liabilities stems from FSMA §107 concerning re-inspection fees. It is believed that in 2013 the FDA will begin charging $289 per hour for the time it devotes to re-inspecting foreign food facilities, resulting in the potential for invoices to reach several thousands of dollars per re-inspection. The party the FDA will hold responsible for paying these invoices is the U.S. agent. Accordingly, brokers, forwarders and importers of record will likely want to find alternatives to becoming U.S. agents themselves and foreign food facilities will need to seek out entities to become U.S. agents.
 

(The Globe & Mail)

The Alberta beef packer at the centre of a massive recall is taking full responsibility for the tainted product, as questions mount over why Canadian officials let the company’s plant operate for two weeks after the U.S. deemed the meat unfit to cross the border.

XL Foods, which has been relatively quiet amid the E. coli outbreak, issued a statement on Thursday that stopped short of an apology. The company acknowledged its food-safety practices were “not enough” and said it would work with the Canadian Food Inspection Agency to strengthen them.

The latest developments in Canada’s largest beef recall – now exceeding 1,800 products comprising millions of pounds of meat – underscore flaws in the country’s food-safety regime and raise questions about how much responsibility the inspectors and the inspected each bear. Read more here.
 

(FnB News)

FDA chief Margaret Hamburg predicted that her agency will issue new regulations needed to enforce the Food Safety Modernization Act, a sweeping piece of legislation enacted to upgrade the security of the U.S. food supply after a deadly salmonella outbreak in 2009, very soon.

Hamburg said the implementation process has been slow because Congress has not provided sufficient funds to meet the law’s ambitious demands.

The legislation imposes the biggest changes in food safety since the 1930s and requires the FDA to undertake a major shift from a longstanding reactive role to a system designed to prevent food-borne outbreaks. It also calls for the agency to create new science-based safety standards for fruit and vegetables, packaged foods and food imports.

“Implementing that broadly expansive mandate with limited resources has been a challenge,” Hamburg told a forum hosted by the Centre for Strategic and International Studies, a Washington-based think-tank.

Her comments come at a time when the FDA is working to meet a host of new priorities, including improved international drug regulation, while analysts and industry officials say the agency’s resources could fall prey to deficit reduction talks that are due to resume in Congress after the November 6 election. Read more here.
 

(Skim That)

The Center for Food Safety and the Center for Environmental Health sued the Food and Drug Administration for failing to implement a new food safety law that could help prevent millions from illness and death caused by food-borne illnesses.

The groups say that the FDA failed to meet 7 deadlines for establishing standards for analyzing and documenting hazards and implementing preventative measures as required by the Food Safety Modernization Act signed into law last year.

The FDA says they are awaiting approval of the new standards from the Office of Management and Budget but the groups say the FDA can implement the standards without the OMB’s approval and are putting millions at risk by waiting.

(STR Trade Report)

Rep. Edward Markey, D-Mass., and Sen. Jeff Merkley, D-Ore., have asked the Food and Drug Administration to overhaul and streamline its databases on recalls and 510(k) premarket notifications “to provide publically available and easily searchable information regarding the safety of [medical] devices that rarely undergo clinical trials in humans prior to being sold on the market.” The lawmakers noted that the improvements they are recommending would enhance the transparency of the 510(k) process, help manufacturers avoid using recalled devices as predicates that may put their own devices at risk for future enforcement action, and enhance awareness among the public and medical professionals of the potential dangers of medical devices that are based on flawed predicates. They asked the FDA to respond no later than Sept. 19.

According to the letter, the 510(k) process permits medical devices to be sold as long as the sponsor demonstrates that the product is similar, or substantially equivalent, to a legally marketed device (the predicate). As long as the sponsor shows that the new device is substantially equivalent in design, technology and intended use to the predicate, the FDA is generally required to clear it. Unfortunately, the letter states this requirement applies “even in cases where the new product contains the same flaws as an earlier model that had to be recalled by the manufacturer due to a fundamental design flaw.”

The two lawmakers said they believe the solution to this problem will require (a) enabling the FDA to reject clearance if a device repeats design flaws that have led to the voluntary recall of earlier products, as proposed in H.R. 3847, The Safety Of Untested and New Devices Act, and (b) providing device manufacturers, the public and medical professionals with better information about devices recalled for serious design flaws. They asserted that this greater transparency could be accomplished by the FDA updating its 510(k) database to reflect if the device was the subject of a recall because of a serious design flaw that negatively affected safety or effectiveness and whether the device was cleared on the basis of a predicate recalled for a serious design flaw that negatively affected safety or effectiveness. In these cases, the database entry for such a device should provide a link to information about the predicate’s adverse event reports and recall.
 

(Loic Hostetter – U-T San Diego)

In a globalized economic atmosphere that relies on quick communication and low trade barriers, the U.S. government is responding with a multiagency strategy for regulating and protecting the nation’s food supply.

Part of this trend was on display Monday at the Otay Mesa Port of Entry, one of the busiest commercial ports along the U.S.-Mexico border.

A series of white trailers and trucks sat in the California Highway Patrol parking lot there. While nondescript from the outside, the trailers are packed with an array of scientific equipment used to test U.S.-bound agricultural imports for various contaminants and pathogens. Read more here.
 

(STR Trade Report)

The Food and Drug Administration is still working to launch a pilot program that could offer expedited entry for certain imported drugs and drug ingredients. Foreign manufacturers of finished drug products and active pharmaceutical ingredients intended for human use that are imported by a secure supply chain will be able to apply to participate in this voluntary Secure Supply Chain pilot program. The goal of the pilot is to allow the FDA to determine the practicality of developing a full-fledged secure supply chain program, which it believes would assist in its efforts to prevent the importation of adulterated, misbranded and unapproved drugs.

The FDA first announced this pilot program in January 2009 but FDA sources stated this week that it still has not gotten underway. As part of its current effort to move the pilot forward the agency is requesting comments no later than July 20 on its request for Office of Management and Budget approval of associated information collections. Sources said the pilot will not begin until OMB approval is secured, which is not expected for at least several more months. Read more here.
 

(STR Trade Report)

The Food and Drug Administration has unveiled a new automated system for companies exporting food from the U.S. to file electronically for certificates of free sale. Such certificates are often requested by international customers or governments to verify that the products being exported meet certain standards.

The FDA Unified Registration and Listing Systems Certificate Application Process allows exporters of conventional foods, including seafood, to apply online for a CFS, reducing the amount of time required for the FDA to process requests and issue certificates. Exporters who create a CAP account will be able to apply for new certificates, modify existing applications and check the status of pending applications. To create an account, companies will need to enter the food facility registration number and passcode they received when they registered under the Bioterrorism Act of 2002.

The FDA notes that while companies will now be able to apply for a CFS electronically they can still request certificates by mail. In addition, even if the application is made electronically, at this time certificates are available only as hard copies that are mailed to the applicant.

(Food Safety News – Helena Bottemiller)

The U.S. Food and Drug Administration released a new report this week outlining the ways the agency is trying to fulfill its mission globally. Though the report, titled “Global Engagement Report,” covers the broad swath of FDA-regulated products, including medical devices, drugs and cosmetics, it also details some of the agency’s key food safety initiatives abroad.

“As our world transforms and becomes increasingly globalized, we must come together in new, unprecedented, even unexpected, ways to build a public health safety net for consumers around the world,” said FDA Commissioner Margaret Hamburg.

As FDA points out, the agency is charged with regulating products from more than 150 countries, 130,000 importers and 300,000 foreign facilities. Since 2005, food imports have grown year over year by an average of 10 percent. Read more here.
 

(Matthew Perrone — Bloomberg Businessweek )

Food and drug regulators in the U.S., Europe and other developed countries should offer training, technology and expertise to developing nations in Asia, Latin America and other regions to better assure the safety of imported products, states a new report.

An expert panel assembled by the Institute of Medicine recommends the U.S. Food and Drug Administration work with counterparts throughout the world to secure supply chains for imported food and drugs, which increasingly cross borders. More than 80% of pharmaceutical ingredients are imported from abroad, as well as 85% of the seafood consumed in the U.S., according to federal figures.

“The integrated global economy demands cooperation across borders – to thwart terrorists, reduce environmental hazards, and ensure that our food and medical products are safe and effective,” states the 300-page report released Wednesday. Read more here.
 

(Kelley Drye & Warren LLP)

Protecting the US food supply from intentional adulteration requires coordination at all levels of government and throughout the private sector. Companies engaged in the manufacture, importation, distribution or storage of food for the U.S. market will be interested in a new article published by the Food and Drug Law Institute that provides an introduction to post-9/11 policy developments related to the incorporation of new intentional adulteration safeguards into U.S. food supply regulations.

The article reviews the authority granted to FDA by the Food Safety Modernization Act, the responsibilities of other government agencies in protecting against intentional adulteration, and the efforts of nongovernmental entities to minimize risks in the supply chain.