Monthly Archives

January 2013

FDA IssuesFoodFSMAImport

FDA’s Busy Implementing FSMA – Significant New Food Safety Rules are Coming

posted by Jennifer Diaz January 30, 2013 0 comments

The FDA has proposed two new rules issued under the Food Safety Modernization Act (FSMA) that is part of a broader effort to prevent food borne illness and ensure the safety of imported and domestically produced foods.  If you want your voice heard, you have until May 16, 2013 to submit your comments to the FDA on the proposed rule. The FDA does take comments seriously, we’re here to help if you want assistance in drafting your comments. This rule is expected to be published shortly following the conclusion of the comment period on May 16, 2013.  

The proposed rules would apply to facilities that manufacture, process, pack or hold human food. The rules focus on commonly identified routes of microbial contamination of produce, including:

(1) agricultural water

(2) farm worker hygiene

(3) manure and other additions to the soil

(4) animals in growing areas, and

(5) equipment, tools and buildings.

In general the facilities that are required to register include manufacturers, processors, warehouses, storage tanks, and grain elevators. However, there are a number of exemptions and modified requirements. We would be pleased to assist you in determining whether or not your facility may be exempt from these requirements.  

Below is a recap of the proposed rules.

Rule #1 – Preventative Controls for Human Food.  The rule proposes firms have written plans in place to identify potential hazards, put in place steps to address them, verify that the steps are working, and outline how to correct any problems that arise. The rule proposes each covered facility to prepare and implement a written food safety plan, which would include the following:

  • hazard analysis;
  • risk based preventive controls;
  • monitoring procedures;
  • corrective actions; 
  • verification; and
  • recordkeeping

Do you have your written plan in place yet?

Rule #2 – Produce Safety.  The second rule proposes enforceable science- and risk-based safety standards for growing, harvesting, packing and holding fruits and vegetables on foreign and domestic farms. These standards include requirements addressing major areas specific to agriculture that can be the conduit for contaminants:

  • Irrigation and other agricultural water
  • Farm worker hygiene
  • Manure and other additions to the soil
  • Intrusion of animals in the growing fields.
  • Sanitation conditions affecting buildings, equipment and tools

The proposed rule also includes additional provisions applicable to the growing, harvesting and packing of sprouts, which are more vulnerable in their growing environment to harmful bacteria.

The rules still to come are:

  •  Foreign Supplier Verification for Importers: This program will require importers to verify that foreign suppliers are following procedures that provide the same level of health protection as that required of domestic food producers. About 15 percent of the food consumed in the U.S. is imported, including about 49 percent of fresh fruit and 21 percent of vegetables.
  • Accredited Third Party Certification: The accreditation of third-party auditors would help ensure that food producers in other countries comply with U.S. food safety laws.
  • Preventive Controls for Animal Food: This is the implementation of preventive controls at animal food facilities that are similar to those proposed for human food.

As FDA implements more of FSMA, we will keep you informed. 

Do you need assistance in submitting a comment to FDA? Does your company need training on FSMA? If so, contact me anytime.  

FDA IssuesFoodFSMA

On February 1, 2013 Many Food Facilities Face Suspension

posted by Jennifer Diaz January 22, 2013 0 comments

The U.S. Food and Drug Administration (FDA) extended the deadline for the biennial registration renewal for food facilities until January 31, 2013. Your time is almost up to re-register! If your not re-registered, enforcement will begin on February 1, 2013. FDA will cancel your Bioterrorism Act registration and your importations will be significantly delayed. Your facility will NOT be able to import, distribute or sell food products in the U.S. 

Here’s what you need to know about FDA’s new FSMA requirement on Bioterrorism Act registrations. Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food, alcoholic beverages, and/or dietary supplements for consumption in the U.S. are required to register the facility with the FDA. 

The Food Safety Modernization Act of 2011 (FSMA) has for the first time, specifically put the onus on importers to have a program to verify that the food products they are bringing into this country are safe. The idea behind FSMA is to change FDA regulatory enforcement and focus to more of a preventative approach, instead of reactionary. These new requirements include risk-based controls, foreign supplier verification program, certification, and audits. A brief overview of the requirements may be found here.

I’ve summarized the requirements relevant to your Bioterrorism Act Registration below, so you can be sure your registration doesn’t lapse. 

New Biennial Registration Requirements

FSMA amended the Food, Drug & Cosmetic Act (FD&C Act) Section 415 to provide for biennial registration updates. Facilities which are required to register will have to re-register every 2 years, during the period beginning on October 1 (in this case, October 22) and ending on December 31 in even numbered years. This will first occur in October-December 2012 (which FDA extended until January 31, 2013, as renewals did not start until October 22).

Note that even facilities which are already registered with the FDA are still required to renew their registrations during the October 22– January 31, 2013 extended registration renewal period.

U.S. Agent

FDA requires that foreign facilities have a U.S. agent. The U.S. agent must:

  1. live or maintain a place of business in the U.S. and
  2. be physically present in the U.S.

The U.S. Agent is also responsible for the payment of "reinspection fees" of foreign facilities and failure to comply with recall orders. Reinspections are follow-up inspections conducted by the FDA after a previous inspection by the FDA where the FDA identified non-compliance issues materially related to food safety. The purpose of the reinspection is to assure the issue has been remedied and food is now safely produced. Fees are adjusted each fiscal year. For FY 2013 (October 1, 2012-September 30, 2013), the fees are steep, at $221 an hour if no foreign travel is required, and $289 an hour if foreign travel is required.

Need a U.S. Agent?

The law firm Becker & Poliakoff, P.A. provides registration services and will act as a U.S. agent with the FDA for a nominal fee, but, the foreign facilities are always responsible for the payment of any reinspection fee or fee for a failure to comply with a recall order. Please visit www.FDA-USA.com for more information about how to make Becker & Poliakoff, P.A. your U.S. agent with the FDA.

Contact Jennifer Diaz with any questions  and ensure your importation are not delayed come February 1, 2013.

C-TPATCBP

What You Missed at the C-TPAT Conference

posted by Jennifer Diaz January 18, 2013 0 comments

The Customs-Trade Partnership Against Terrorism is a voluntary government-business initiative that builds cooperative relationships that strengthen and improve overall international supply chain and U.S. border security. C-TPAT is widely recognized as one of the most effective means of providing the highest level of cargo security through close cooperation with international supply chain businesses such as importers, carriers, consolidators, licensed customs brokers, and manufacturers. At CBP’s C-TPAT Conference held on January 8-9, 2013, CBP announced major updates to C-TPAT – lucky for you, I’ve recapped the highlights for you below.

Trusted Trader Program

  • CBP proposes to combine CBP’s ISA program with C-TPAT.  Additionally, if importers choose to be part of the Trusted Trader Program, they can take advantage of “joint validations” with other government agencies (OGA’s).  CBP and TSA have already been performing joint validations for 9 months.  Trade is concerned that OGA’s will go on fishing expeditions while validating and no guarantees have been made from CBP that OGA’s won’t. This is a major concern for some (rightfully so!).
  • CBP is seeking comments regarding its new Trusted Trader Program. Please email any comments here.

Internal Conspiracies

Top conspiracy indicators to look for are:

  • Anyone taking photos of entrances, fencing, hours of operation, etc..
  • Anyone interested in stow plans, employee schedules, transit routes, and GPS
  • Anyone in financial distress
  • Anyone attempting to access a system that they have no authorization to access
  • Anyone showing up to work on a day off or with large bags
  • Anyone entering restricted zones without access

Container Inspection

Use the VVTT process:

  • View seal and container locking hardware
  • Verify seal #
  • Tug on seal to make sure it is on right
  • Twist and turn seal to make sure it doesn’t unscrew.

Most Common Areas of Failed Criteria:

  • Conveyance Security – tracking an monitoring                    51%
  • Container Security – sealing/ container inspection               49%
  • Business Partners – screening and subcontracting              46%
  • Personnel Security – background checks                            31%

SW Border Strategies 

  • 86% of the time the drivers are responsible and have some involvement in conspiracies
  • There were 41 seizures representing C-TPAT companies in 2012
  • There are 160 underground tunnels from Mexico the U.S. or Canada to the U.S.

Evidence of Implementation

Suspensions and removals from January 2002-November 2012:

  • 403 importers suspended due to validation issues
  • 339 were removed from C-TPAT

CBP expects:

  • C-TPAT Manuals including all minimum security procedures
  • Documentation of audits, checklists, appropriate training
  • Assurance that all documentation is uploaded into the portal
  • Checklists to be uploaded that are filled out (blank forms will no longer be acceptable)
  • Photo and video evidence of implementation may be requested
  • If you DON’T contact your CBP Supply Chain Security Specialist (SCSS) when illegal activity is detected, it is a STRIKE against you

Visitor logs

  • Only for unknown visitors
  • Don’t let visitors sign themselves in!

C-TPAT Portal 2.0 

  • Expect changes to the portal in the summer, it’s in early prototype stages now
  • You will not have to be a C-TPAT member to create a user account
  • SVI numbers will go away, tracking will be done using a business name and type
  • Members will have the ability to share documents
  • The new structure will give you the ability to combine common security practices, this is beneficial if you have more than one user account

Thomas Winkowski, Acting COO of CBP 

  • Over 55% of goods entering the U.S. are from C-TPAT certified partners
  • CBP is pushing for more Mutual Recognition Agreements (MRA’s)
  • CBP currently has 7 MRA’s in place
  • MRA’s on the horizon with Taiwan, China, Israel and Mexico

Kevin McAleenan, Acting Assistant Commissioner, Office of Field Operations (OFO) 

  • CBP is working on advancing benefits to C-TPAT members
  • New CBP Director Lauren Koffer was announced!  

Dan Baldwin, Executive Director

 

Currently CBP has:

  • 10,452 certified partners
  • 158 – CBP staffing level
  • 328 – Tier 3 IOR’s
  • 22,223 – Total Validations Completed since inception

Concern regarding budget and number of validations CBP will be able to complete for FY13

  • In 2012 there were 822 new companies that applied for C-TPAT & 693 of those were certified

Barry Brandman, President, Danbee Investigations

 

Top 5 best practices:

  1. Must enlist senior management support
  2. Culture and security excellence (Don’t meet standards, exceed them)
  3. Apply checks and balances throughout (Anticipate that your first line of defense will fail)
  4. Strategically utilize security technology
  5. Diligently audit safeguards to expose weaknesses

If you have questions regarding submitting a C-TPAT application, C-TPAT validations, advancing in tier status, or any pending C-TPAT program changes, feel free to contact me.   

Best PracticesIPR, Trademarks and Logos

Protecting Your Intellectual Property Internationally

posted by Jennifer Diaz January 12, 2013 0 comments

Do you sell products in multiple countries?  How are you assuring your intellectual property is protected?  Do you know about "Foreign Patent Applications" or "PCT’s"?  If not, you may not be adequately protecting your intellectual property abroad!

When you sell your product in multiple countries you are vulnerable to other companies stealing your idea and reproducing your intellectual property as their own.

How do you protect yourself?

To protect your business from being taken advantage of you may consider filing a foreign patent application. You may ask, what’s a foreign patent application?  It’s a request at a foreign patent office for the grant of a patent for the invention described and claimed by that application. An application typically consists of a description of the invention, together with official forms and correspondence relating to the application.

Foreign patent protection will prevent others from profiting from your idea abroad. Many countries allow you to claim priority from your U.S. application. For utility patents you can file with priority status within one year of your original filing date in the U.S. under the Paris Convention, or six months from your original filing date for design patent applications. A utility patent protects the functional aspects of an invention and can provide broad patent protection, making it difficult for a competing product to avoid patent infringement. A design patent will protect the appearance of a new product as long as it is the main feature.

Another option you have is to file a PCT (“Patent Cooperation Treaty”) patent application for up to two and a half years from the initial filing date of your U.S. patent application. The PCT must be filed within a year of your first filed priority application to keep your priority date or before your U.S. application is published. The benefit to filing a PCT patent application is it allows you additional time to file in the specific countries of your choice. In some cases, the results of the search report issued for the PCT may be used to speed up prosecution in individual foreign countries and result in lower prosecution costs using the PCT Patent Prosecution Highway Petition.

Becker & Poliakoff, P.A. is proud to announce we have merged with Litman Law and are now offering a full range of intellectual property services, including patent and trademark services, to our valued clients. To learn more about protecting your brand internationally, please contact us.