January 2013

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

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 […]

By |2022-07-07T09:32:30-04:00January 30, 2013|FDA Issues, Food, FSMA, Import|0 Comments

On February 1, 2013 Many Food Facilities Face Suspension

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 […]

What You Missed at the C-TPAT Conference

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. CTPAT 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 CTPAT Conference held on January 8-9, 2013, CBP announced major updates to CTPAT – lucky for you, I’ve recapped the highlights for you below.

Trusted Trader Program

• CBP proposes to combine CBP’s ISA program with CTPAT. 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 […]

Protecting Your Intellectual Property Internationally

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 […]

By |2022-07-08T15:56:51-04:00January 12, 2013|Best Practices, IPR, Trademarks and Logos|1 Comment
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