GHY Tradelines

(STR Trade Report)

The Food and Drug Administration has published two new documents to provide the import trade community with the most current affirmation of compliance codes available for use with FDA-regulated products. The “FDA Affirmation of Compliance Code Reference Guide” provides a detailed explanation of each code and the proper qualifier syntax. The “FDA Affirmation of Compliance Code Quick Reference” is a one-page document designed to help filers determine which codes are applicable by commodity type and if a qualifier is required.

One of the functions of the FDA-Automated Commercial System interface is the automated screening of FDA-regulated import entries to determine which may proceed without FDA examination and which require further FDA review. An AofC code, transmitted at the FDA line level, is one data element used in this screening process. By using an AofC code, the filer affirms that the firm or product identified in a FDA line meets requirements specific to each code. While submission of this information is voluntary, it may expedite initial screening and further review of an entry.
 

(Jonathan Gold – LAT)

Are weeks gray without a sliver of Tuscan lardo? Do you crave coppa made from Cinta Senese pigs? Have you ever considered attaching a gold chain to a whole prosciutto in an attempt to persuade a customs inspector that it was a kicky Fendi bag?

You may be in luck. According to the Italian wire service ANSA, the U.S. Animal and Plant Health Inspection Services announced Friday that the long-standing FDA ban on the import of Italian cured meats will be lifted starting May 28, and presumably the flood of salami, bresaola and pancetta will start washing into U.S. markets and restaurants not long thereafter. 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.
 

(Julian Hattem – The Hill)

To pay for food safety measures in its $4.7 billion budget, the Food and Drug Administration (FDA) is proposing new fees to make up the gap.

The budget request released by the agency on Wednesday called for industry fees to make up 94% of the budget’s nearly $500 million increase from the previous year, and nearly half the agency’s budget in 2014. […]

Many of the new fees will be used to support the 2011 Food Safety Modernization Act, which directed the FDA to focus on preventing food contamination before it occurs, rather than responding to new outbreaks. Programs to support that law, scheduled to cost $295 million next year, will be 85% funded by user fees. Read more here.
 

(STR Trade Report)

The fiscal year 2014 budget proposal released by President Obama this week includes funding increases for many federal agencies with trade-related responsibilities.

Commerce

- $520 million (up $64 million from FY 2012) for the International Trade Administration to support the National Export Initiative, including $22 million for the Interagency Trade Enforcement Center and $20 million to support implementation of the SelectUSA program, which encourages foreign direct investment in the U.S.

- $12 million for the Economic Development Administration to create a Regional Export Challenge, a competitive grant program that will support U.S. regions that develop and implement sustainable export action plans to proactively identify and support firms and sectors with the greatest export potential

- $112 million (up $11 million) for the Bureau of Industry and Security to support ongoing work under the Export Control Reform Initiative, including an additional $8.3 million for expanded export licensing and enforcement operations as controlled items shift from State Department jurisdiction

- the expansion of export control officers to Germany (covering Europe), Turkey (covering Malta, Cyprus, Syria, Jordan, Egypt, Lebanon and Israel) and the United Arab Emirates (covering Pakistan, Bahrain, Iraq, Kuwait, Oman, Qatar, Saudi Arabia and Yemen)

- organizational changes such as focusing on higher priority enforcement and compliance activities such as antidumping and countervailing duty casework and ITEC; reducing the number of Global Markets specialists who combat non-tariff barriers in customs, standards and transparency in markets that are not priorities or have a limited return on investment; and consolidating GM staff to cover priority markets such as free trade agreement partners, emerging markets such as China and India, and next tier markets such as Turkey and Indonesia

CBP

- $12.9 billion for U.S. Customs and Border Protection, including $221 million for 1,600 new CBP officers and mobile equipment to speed the processing and inspection of passengers and cargo at U.S. ports of entry

- $3.3 million for the automation and centralization of CBP processing of all single transaction bonds

- increases in customs inspection user fees

- transfer of land border port of entry facilities from the General Services Administration to CBP

FDA

- an additional $295.8 million to bolster the Food and Drug Administration’s food safety efforts, primarily through implementation of the Food Safety Modernization Act

- new user fees for food facility registration and inspection, food importers, and cosmetics and food contact substance notifications

- a $10 million increase for FDA efforts to detect and address the risks of food and medical products and ingredients manufactured in foreign countries

Other Trade Agencies

- $85.1 million for the International Trade Commission (up $5.1 million)

- $56.2 million for the Office of the U.S. Trade Representative (up $5 million)

- $117 million for the Consumer Product Safety Commission (up $2 million)

- $25 million for the Federal Maritime Commission (up $1 million)

(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.
 

(CSCFSC)

On 12 February 2013, FDA provided additional details for the three consultation sessions that it has planned on the proposed regulations it published earlier this year. The public meetings will be held in:

• Washington on February 28th and March 1st
• Chicago on March 11th and 12th
• Portland, Oregon on March 27th and 28th

Detailed information about the meetings can be found here.

The FDA has also released a number of supporting documents about these proposed rules, including an overview document and two fact sheets (one for preventive controls and one for produce safety). These can be accessed the main FSMA webpage.

The initial comment period on “information collection issues” – i.e., concerns about the “paperwork burden” as required by the Paperwork Reduction Act of 1995 – closed on February 15^th but the comment period on the content of the proposed regulations is open until May 16th.
 

(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.
 

Canadian companies manufacturing and exporting food to the U.S. that is regulated under the Food Safety Modernization Act and U.S. FDA are required to register or renew their registration prior to January 31, 2013. More information can be found here.

Some firms have reported challenges dealing with U.S. FDA PIN numbers and understanding what should be done if a company cannot access their current PIN number. FDA has provided clarity through the Q&As on the FDA website [link above] in response to queries from the trade community. The updated questions and answers specifically addressing the use of the PIN number are provided below for ease of reference.

I do not have the Food Facility Registration PIN number that is required to access my registration in the online registration system, and therefore I am unable to renew my registration. What steps should I take?

Due to certain confidentiality constraints and the amount of time it takes the Agency to process PIN requests, the Agency is no longer able to fulfill PIN requests for registration renewals for the 2012 renewal period. If a facility is unable to renew its existing registration by January 31, 2013 because it does not have its PIN number, the facility may create a new registration by January 31, 2013 in order to be registered in accordance with section 415 of the FD&C Act.

If I create a new registration, will I retain my compliance history or shipping history associated with my facility?

Some facilities may create new registrations rather than renew existing registrations because they no longer have the PIN numbers that are needed to access their existing registrations in the online registration system. For such a facility, the Agency does not anticipate a loss of compliance history or shipping history, provided that the facility’s new registration includes the same information such as facility name and facility address.
 

(STR Trade Report)

The Food and Drug Administration has introduced an electronic process for submitting requests for export certificates for products regulated by the FDA’s Center for Devices and Radiological Health. The FDA states that the new eSubmitter process will be a voluntary option to the current paper-based process, which will remain in place, but suggests that it could become mandatory at some point.

The eSubmitter process will be introduced in two phases. In the first phase, the CDRH Export Certification Application and Tracking System will be made available to industry for the electronic submission of requests for export certificates. The CECATS module is a part of the FDA Unified Registration and Listing System within the FDA Industry Systems Portal utilized to automatically issue export certificates to U.S. medical device manufacturers/distributors who wish to export their medical devices to foreign countries. The FDA notes that the advantages to industry from this new electronic system will be to greatly reduce certificate processing time, eliminate the need to return submissions through automated real-time validation, and allow companies to receive real-time updates on the status of their requests via the Web. CDRH is developing webinars and will hold online training sessions with industry on how to access and use CECATS, and a schedule and detailed instructions will be posted later.

The FDA plans to implement in early 2013 phase two of the eSubmitter process covering the remainder of the export certification, notification and permit requests.
 

(STR Trade Report)

U.S. Customs and Border Protection issued Jan. 16 a message warning importers to ensure that the foreign food facilities from which they import food into the U.S. are registered with the Food and Drug Administration.

The 2002 Bioterrorism Act requires all domestic and foreign facilities that manufacture, process, pack or hold food, beverages, food ingredients, pet foods or dietary supplements for consumption in the United States to register as a food facility with the FDA. Section 102 of the FDA Food Safety Modernization Act updated that law to require such registrations to be renewed between Oct. 1 and Dec. 31 of each even-numbered year. The initial renewal deadline was Dec. 31, 2012, but in light of various circumstances the FDA is exercising enforcement discretion for late-filed renewals through Jan. 31. Nevertheless, facilities are encouraged to renew their registrations as early as possible.

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. CBP adds that beginning Feb. 1 if a foreign food facility fails to renew its registration, food from that facility that is being imported or offered for import into the U.S. could be held at the port or refused upon arrival into the U.S.

The FDA is therefore encouraging import filers who file prior notices for food shipments to contact clients with high-volume food shipments, inquire about the FSMA registration renewal status of foreign manufacturing facilities associated with their shipments, and confirm any new registration numbers. CBP states that doing so could greatly mitigate any prior notice shipment delays related to registration on or after Feb. 1. In the event of an import prior notice ABI transaction rejection indicating that the transmitted registration is invalidated, filers should contact the individual submitting the information and request updated registration information for correction.
 

(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.