2016 Food Facility Registration Biennial Renewal
Food & Drug Administration
2016 Food Facility Registration Biennial Renewal period begins at 12:00 AM on October 1st and ends at 11:59 PM on December 31, 2016.
Please be advised that updating your registration is a different function than renewing your registration. During the renewal period, you will not see the “Update Facility Registration” button listed on the FFRM main menu, until the registration is renewed. If a registration is not renewed by 11:59 PM on December 31st, the registration will expire and be removed from your account.
FDA is continuing to use the version of the food facility registration form, Form FDA 3537, that was in use prior to the July 14, 2016 issuance of the Amendments to Registration of Food Facilities final rule (81 Fed. Reg. 45912). This version of the form does not include all of the data elements required by the July 14, 2016 final rule. FDA plans to implement a revised version of the form shortly.
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) directs the Food and Drug Administration (FDA), as the food regulatory agency of the Department of Health and Human Services, to take steps to protect the public from a threatened or actual terrorist attack on the U.S. food supply and other food-related emergencies.
To carry out certain provisions of the Bioterrorism Act, FDA established regulations requiring that:
- Food facilities register with FDA, and
- FDA be given advance notice on shipments of imported food.
These regulations became effective on December 12, 2003.
The FDA Food Safety Modernization Act (FSMA), enacted on January 4, 2011, amended section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), in relevant part, to require that facilities engaged in manufacturing, processing, packing, or holding food for consumption in the United States submit additional registration information to FDA, including an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act. Section 415 of the FD&C Act, as amended by FSMA, also requires food facilities required to register with FDA to renew such registrations every other year, and provides FDA with authority to suspend the registration of a food facility in certain circumstances. Specifically, if FDA determines that food manufactured, processed, packed, received, or held by a registered food facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals, FDA may by order 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.
Update on China Shipping - Port of Los Angeles
Port of Los Angeles Executive Director Gene Seroka gives an update on the status of the China Shipping Supplemental Environmental Impact Report. The remarks are from the Sept. 15, 2016 Los Angeles Harbor Commission meeting.
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About One-Third of Hanjin's Ships Have Discharged Cargo
Read at American Shipper
U.S. – China Joint Intellectual Property Rights Enforcement Operation - U.S. Customs & Border Protection
WASHINGTON—U.S. Customs and Border Protection (CBP) and the General Administration of Customs of the Peoples’ Republic of China (GACC) conducted their second joint intellectual property rights (IPR) enforcement operation in April. The month-long operation resulted in the seizure of over 1,400 shipments of counterfeit automobile parts, electronics, identification tags and labels, certain pharmaceutical products, bags, shoes, and other apparel products.
During the operation, both CBP and GACC focused on stopping shipments of IPR infringing goods from entering U.S. commerce, with CBP making seizures at the U.S. border and GACC interdicting exports of counterfeit goods destined to the United States.
The Office of Trade’s IPR Policy & Programs Director, Mr. Michael Walsh, explained, “The United States and China have a lot of enforcement concerns in common, and being able to talk about them and to work in collaboration is a big step in the right direction. We are confident that this meeting has helped to expand the working relationship between our two countries.”
CBP will continue to work closely with GACC to tackle IPR issues, as China remains the top exporting country for counterfeit and pirated goods to the United States. The two customs agencies will continue to share information and seizure data to effectively target shipments of IPR infringing goods.
Intellectual Property Rights is a CBP Priority Trade Issue. This joint operation is an example of how CBP works with international partners to accomplish a common goal of deterring and disrupting illegal trade in IPR infringing products. For additional information on CBP’s IPR enforcement efforts, see www.cbp.gov/trade/priority-issues/ipr
CBP at Port of Norfolk Seizes Chop Shop Contraband Destined for Jordan - U.S. Customs & Border Protection
NORFOLK VA— U.S. Customs and Border Protection (CBP) Office of Field Operations officers working at the Port of Norfolk, Va., seized stolen vehicles and automobile parts on September 13, that were destined to Jordan. The auto parts were valued at approximately $85,000.
An export shipping container arrived from Chicago. During a random export examination, CBP officers identified half-cut vehicles in very good condition and a variety of auto parts, including a 2015 Infinity engine, and parts to a 2007 Cadillac Escalade. CBP officers investigated and determined the parts to be reported stolen in Illinois and Indiana. With assistance of the National Insurance Crime Bureau, CBP officers identified additional suspect vehicles and auto parts. In total, 11 partial vehicles were confirmed stolen and seized by CBP officers.
"Transnational criminal organizations operate a variety of illegal business practices, including the exportation of stolen or fraudulently purchased vehicles and automotive parts, to fuel their nefarious enterprises,” said Area Port Director Mark J. Laria. “As the nation’s border security agency, it is Customs and Border Protection mission to disrupt these illicit activities and to strike a blow to criminal organizations where it hurts most, in the wallet.”
CBP officers will turn the seized auto parts over to the Virginia State Police.
CBP officers at Port of Norfolk have a dedicated team of officers who work closely with other federal, state and local law enforcement agencies. CBP conducts inspection operations, intercepts currency, weapons, and prohibited agriculture products or other illicit items at U.S. ports of entry nationwide.
FDA Launches Competition to Spur Innovative Technologies to Help Reduce Opiod Overdose Deaths - Food & Drug Administration
Contest seeks to stimulate development of a mobile app to connect those experiencing an overdose with the potentially life-saving antidote
The U.S. Food and Drug Administration today announced the 2016 Naloxone App Competition, a public contest focused on developing innovative technologies to combat the rising epidemic of opioid overdose.
The FDA, with support from the National Institute on Drug Abuse (NIDA) and the Substance Abuse and Mental Health Services Administration (SAMHSA), is inviting computer programmers, public health advocates, clinical researchers, entrepreneurs and innovators from all disciplines to create a mobile phone application that can connect opioid users experiencing an overdose with nearby carriers of the prescription drug naloxone – the antidote for an opioid overdose – thereby increasing the likelihood of timely administration and overdose reversal.
This competition builds on work announced in the FDA’s Opioids Action Plan and the U.S. Department of Health and Human Services’ Opioid Initiative (PDF - 350KB) to take concrete steps toward reducing the impact of opioid misuse, dependence and overdose on American families and communities by making naloxone more accessible.
“With a dramatic increase in the number of opioid overdose deaths in the U.S., there’s a vital need to harness the power of new technologies to quickly and effectively link individuals experiencing an overdose – or a bystander such as a friend or family member – with someone who carries and can administer the life-saving medication,” said FDA Commissioner Robert M. Califf, M.D. “Through this competition, we are tapping public health-focused innovators to help bring technological solutions to a real-world problem that is costing the U.S. thousands of lives each year.”
According to SAMHSA, nearly two million Americans abused or were dependent on prescription opioids in 2014. Additionally, overdose deaths involving prescription opioids such as oxycodone, hydrocodone and morphine and illicit opioids, such as heroin and illegally produced fentanyl, have more than tripled since 1999 – with about 28,000 people dying in 2014 alone. Many of these deaths could have been avoided if people experiencing an overdose had immediately received naloxone to stop or reverse the effects of an opioid overdose.
Naloxone is currently only available in the U.S. by prescription, but many states have taken steps to make it more readily accessible to first responders, community-based organizations and laypersons, including friends and family of opioid users. In fact, the number of laypersons provided naloxone nearly tripled between 2010 and 2014, according to the U.S. Centers for Disease Control and Prevention. However, persons carrying naloxone may not be present when an overdose occurs.
“The goal of this competition is to develop a low-cost, scalable, crowd-sourced mobile application that addresses this issue of accessibility,” said Peter Lurie, M.D., M.P.H., associate commissioner for public health strategy and analysis at the FDA. “Mobile phone applications have been developed to educate laypersons on how to recognize an overdose and administer naloxone, and to connect bystanders with individuals in need of other medical services, such as CPR. To date, however, no application is available to connect carriers of naloxone with nearby opioid overdose victims.”
Teams and individuals wishing to participate in the competition will have until Oct. 7, 2016 to register. Registrants will have access to background resources, including information on the opioid epidemic, the approved formulations of naloxone, the public health recommendations for the safe and appropriate use of naloxone and FDA guidance on mobile medical applications. On Oct. 19-20, 2016, the FDA will host a two-day code-a-thon on the FDA campus and virtually for registered entrants to develop their concepts and initial prototypes. All code will be made open-source and publicly accessible, and collaboration will be encouraged. Competition participants will then independently refine their concept and submit a video of a functional prototype along with a brief summary of their concept for the development and use of the app by Nov. 7, 2016.
A panel of judges from the FDA, NIDA, and SAMHSA will evaluate submissions and the highest-scoring entrant will receive an award of $40,000. Following the competition, entrants also may apply for NIDA Small Business Innovation Research (SBIR) grants, subject to eligibility requirements set forth in the SBIR funding opportunity announcement, to further develop their concepts and to develop data to evaluate their real-world impact.
The Naloxone App Competition was developed under the America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science (COMPETES) Reauthorization Act of 2010, which grants all federal agencies broad authority to conduct prize competitions to spur innovation, solve tough problems and advance their core missions.
Follow the Naloxone App Competition on social media using #NaloxoneApp.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
China Moves to Reopen Market to U.S. Beef - USDA
WASHINGTON, Sept. 22, 2016 – Agriculture Secretary Tom Vilsack today issued the following statement:
"I welcome the announcement from China's Ministry of Agriculture that it has lifted its ban on U.S. beef following a recently concluded review of the U.S. supply system. This announcement is a critical first step to restore market access for U.S. beef and beef products. We look forward to prompt engagement by the relevant authorities for further technical discussions on the specific conditions that will allow trade to resume. True access to China's beef market—consistent with science-based, international standards for trade—remains a top priority for the United States. The United States produces the highest-quality beef in the world, and China's 1.3 billion consumers are an important market for U.S. producers. The Obama Administration and USDA will continue to press trading partners to eliminate unfair barriers to trade that hamper American farmers and ranchers."
Background for Reporters
Following the discovery of a case of bovine spongiform encephalopathy (BSE) in December 2003, U.S. beef and beef product exports fell. Since 2003, USDA has led a multi-agency, full-court press, dedicating significant resources to restore foreign market access for U.S. beef. As a result, U.S. beef shipments had regained pre-BSE volumes by 2011 and even reached record values by 2014. Another central element of the U.S. strategy to maintain and expand foreign market access is insistence on policies that are based on the guidelines of the World Organization for Animal Health (OIE). Since January 2015, USDA has gained additional market access for U.S. beef in 16 countries, including: Colombia, Costa Rica, Egypt, Guatemala, Iraq, Lebanon, Macau, New Zealand, Peru, Philippines, Saint Lucia, Singapore, South Africa, Ukraine, Vietnam and Brazil.
The past seven years have represented the strongest period in history for American agricultural exports, with international sales of U.S. farm and food products surpassing $1 trillion between fiscal years 2009 and the present.
Snapshot of the Beef Export Market in 2003
In FY 2003, U.S. beef exports (excluding beef products) totaled $3.0 billion (0.9 million tons) to 112 countries. As a result of the December 2003 BSE case, U.S. beef exports fell to $1.1 billion (0.3 million tons) in FY 2004.
Snapshot of the Current Market
In spite of some remaining restrictions, which USDA continues to prioritize, U.S. beef exports have recovered to pre-2003 levels. In FY 2015, U.S. beef exports totaled $5.8 billion (0.8 million tons) to 112 countries.
Snapshot of China's Market Now and Then
In 2003, China's imports of beef totaled $15 million (12,000 tons), including $10 million from the United States. In recent years, China's imports have risen dramatically, reaching a record $2.3 billion in 2015. USDA forecasts that China will surpass Japan as the second-largest beef importer (after the United States) with imports estimated at 825,000 tons in 2016. Rapidly rising demand for beef has been fueled by middle-class growth and has made China the fastest-growing beef market in the world.