CBP Commissioner Bersin Tenders Resignation Effective December 30

Customs and Border Protection (CBP) Commissioner Alan Bersin has announced his resignation effective December 30. Deputy Commissioner David V. Aguilar is slated to serve as Acting Commissioner.

In a statement announcing his resignation, Bersin said he was grateful for the chance to lead CBP.

"My service as commissioner has been one of the most rewarding experiences of my public life," Bersin said Thursday. "I am immensely proud of the significant and meaningful achievements we have made on our borders and at our nation's ports of entry over nearly two years."

Bersin's recess appointment term expires Dec. 31.

Will YOUR Tariff be Changed in the 2012 Update??

One way to find out!

CSMS #11-000317, dated December 21, 2011, advises brokers that the 2011/2011 Harmonized Tariff Schedule of the United States (HTSUS) will contain many changes. 

Specifically, the notice states:

To: Automated Broker Interface

Harmonized System Update (HSU) 1108 was created on December 20, 2011 and contains 577 ABI
records and 118 harmonized tariff records.

Changes were made as a result of the 484 (F) Committee. The Committee for the Statistical Annotation of the Tariff Schedules mandated modifications effective January 1, 2012.

As always, these changes will be included in the 2012 USHTS. However, at this time, please contact your client representative for questions regarding specific records.

Adjustments required by the verification of the 2011 Harmonized Tariff Schedule (HTS) were made as well.

The modified records are currently available to all ABI participants and can be retrieved electronically via the procedures indicated in the CATAIR. For further information about this process, please contact your client representative. For all other questions regarding this message, please contact Jennifer Keeling via email at Jennifer.Keeling@dhs.gov.

The prelimary 2012 HTSUS is out!  Time to check your tariffs for the new year.

Did your tariff change?

NEW CBP Technology To Increase Efficiencies at Port Miami

NEWS BLAST! 

U.S. Customs and Border Protection (CBP) is set to launch Enforcement Link to Mobile Operations (ELMOcargo) at the Port of Miami. This technology will allow CBP Officers and Agriculture Specialists to release inspected cargo in real-time.

Currently, CBP Officers and Agriculture Specialists conduct inspections on site, but the subsequent release of cargo is delayed until field personnel return to the office and enter inspection results into their data systems.

With the implementation of ELMOcargo, field officers using handheld devices will be able to immediately clear containers. This device speeds up release time by up to four hours making operations more efficient while continuing to keep the Port secure.

CBP Agriculture Specialist recently started using this new technology as a pilot at other Florida ports and agreed to expand the program to Port Miami starting in January 2012.

About the Port of Miami
The Port of Miami is among America's busiest ports and recognized across the globe with the dual distinction of being the Cruise Capital of the World and the Cargo Gateway of the Americas. The Port of Miami contributes more than $18 billion annually to the South Florida economy and helps provide direct and indirect employment for more than 180,000.

MEDIA CONTACT:
Andria C. Muñiz
305-347-4962
amuniz@miamidade.gov

33 Interesting and Exciting Career Paths in International Business!

We often come across great resources we want to share with others... This is exactly what this post is all about!

I was sent 33 Interesting and Exciting Career Paths in International Business and thought MANY of you could benefit from this.

I hope this is beneficial for you!

10th Annual IBWOY Awards - November 1, 2011 - SAVE THE DATE!!!

On November 1, 2011, the Organization of Women in International Trade's South Florida will host our 10th Annual International Business Women of the Year (IBWOY) Awards (men are absolutely welcome)!

This is my final year as President of OWIT-South Florida, making this IBWOY awards that much more special to me. I hope you will be there to join in this truly exceptional event as we honor 3 outstanding international business women who are helping pave the way for future women leaders.

• WHO:       The Organization of Women in International Trade  
• WHAT:     10th Annual International Business Women of the Year (IBWOY) Awards
• WHEN:      November 1, 2011, 11:00 am - 2:00 pm
• WHERE:   The InterContinental Miami West Hotel - Doral, 2505 North West 87th Ave. Miami, FL 33172
• COST:       Early Bird (register by Sept. 16): $50 members/$65 non-members  Regular/Event Day Registration:  $75 members/$85 non-members Table of ten (10): $500

In addition to our awards portion, we have a silent auction where we donate proceeds to International Business Students in local universities, as part of National Scholarship Month (last year we raised $4,000!). If you have an item to donate, we would be grateful to receive it, please let me know! We also have great sponsorship opportunities, tables for IBWOY are only $500, ($50/ticket as opposed to $65/ticket for non-members). Take advantage of early registration fees as well! ($50/member, $65/non-member until September 16, thereafter, $75/member, $85/non-member).

Let's celebrate a decade of women in international trade together on November 1, 2011!!

RSVP today!

Gluten Free Labeling is Coming - But, First, FDA Wants to Hear From YOU!!!!

Imagine a world where a manufacturer’s claims that their products are “gluten free” could be trusted by U.S. consumers.  Imagine a world where U.S. consumers were promised a definition of “gluten free” by the U.S. Food and Drug Administration (FDA), and the FDA held all manufacturers and importers to the same stringent standard….

Good news, we’re getting close!!

As of August 2, 2011, FDA has re-opened the comment period so that they can hear from YOU.  Yes, YOU!  FDA wants to hear from Celiacs, gluten sensitive consumers, et al. in the U.S.  Why, you ask?  Well, the FDA is firming up their definition of “gluten free”; and wants to know that the gluten free community is satisfied with the FDA’s finalized definition.  So, let’s make sure we tell the FDA what's important to us.  FDA has proposed a definition of "gluten free" in order for the term to be used on labeling of food products.

FDA’s proposed rule defines “gluten free” as products that do not contain:

1. an ingredient that is any type of wheat, rye, barley, or crossbreeds of these grains
2. an ingredient derived from these grains and that has not been processed to remove gluten
3. an ingredient derived from these grains and that has been processed to remove gluten, if it results in the food containing 20 or more parts per million (ppm) gluten
4. 20 ppm (parts per million) or more gluten

FDA wants to hear from the public and industry. The public comment period on the proposed rule will officially open after noon on Aug. 3, 2011, and will remain open for 60 days (until October 3, 2011). FDA prefers electronic comments, go to http://www.regulations.gov/ and

1. choose “Submit a Comment” from the top task bar
2. enter the docket number FDA-2005-N-0404 in the “Keyword” space
3. select “Search”

FDA’s Center for Food Safety and Applied Nutrition (CFSAN) is tasked with making this happen, check out FDA's webpage which shows the safety assessment done to confirm 20 ppm is the correct standard to use.   

FDA held a conference call with industry, where the FDA allowed questions on opening up the comment period, and hopefully bringing truthful gluten free labeling to U.S. consumers soon.  Some questions asked where the methods in which FDA would test manufacturer’s products (answers were the Elisa R5 Mendez method, and Morinaga Method (currently used by the Japanese government for allergen labeling).  Presently, the Food Service and Products industry doesn't have to use these methods, but these are the methods FDA will use for enforcement.  

FDA is well aware that 20 ppm may not protect everyone, FDA wants your comments on this issue, what would truthful gluten free labeling be to you??  I was thinking about a range, 0-5 ppm, 5-10 ppm, 10-15 ppm, etc. to be included with “gluten free.”  FDA was also thinking about low/very low gluten labeling – but, what would be considered low?  What would be low or very low to you?  Tell the FDA!!

As far as timing goes, FDA will review the comments received, and is targeting the 3rd quarter of 2012 to publish a final rule.   

Yours truly asked the FDA about enforcement because I want to know how FDA will check on these products once these standards are implemented.  FDA advised there will be a compliance program set with the new rule, which will likely entail inspections, label review, (although I was hoping to hear about more lab testing of products).  Further, I asked about the size of FDA’s budget to assist in enforcement (once we all agree on definitions and a final rule comes to be…) but, there was no comment from the FDA on the budget to enforce (only a chuckle...).

We all think of the monsters out there who have preyed on Celiac’s/gluten free consumers, and did not in fact sell a gluten free product.  FDA will issue warning letters, seize products, issue injunctions, issue mandatory recalls, etc., when faced with manufacturers who are selling gluten free product that is NOT truly gluten free.

Let’s get to it, let’s tell the FDA you agree with 20 ppm, don’t agree, want low/very low standards (explaining what your tolerances are), or whatever your prospective may be.  FDA is listening, they want to hear from you, speak now!  You have until October 3 to have your voice heard before the final rule, and then, the hope is you will trust the products on your shelves that state, “gluten free”.

FDA's Update on its Regulation of Cosmetic Products

On July 14, 2011, FDA posted an update on how it regulates cosmetic products.  The full update is below for your perusal. In my practice, I have seen warning letters from the FDA, refusals and the insertion of companies on FDA's Import Alert List (goods are automatically detained when entering the U.S., and it is up to the importer to prove to the FDA that the products are in compliance for EACH importation).  It will be interesting to see if the FDA ramps up enforcement for violative cosmetics.  Interesting to note is FDA's newer Import Alert (IA) for cosmetic products - IA  66-38, "Skin Care Products Labeled As Anti-Aging Creams," dated April 8, 2011.  Getting off the Import Alert list is a rather rigorous process, which will be the subject of another post.  Interested to note if you see ramped up enforcement of cosmetics with the new administration?

How FDA Evaluates Regulated Products

 

The Food and Drug Administration’s Strategic Action Plan for Risk Communication is an initiative to tell consumers how the agency makes decisions on the safety and effectiveness of FDA-regulated products. This is the first in a series of articles about the data and methods—and their limitations—that FDA uses to determine whether products are safe for consumers to use.

 

Here's a look at how FDA's Office of Cosmetics and Colors evaluates the safety of cosmetics.

The Regulation of Cosmetics:

Under the Federal Food, Drug, and Cosmetic Act, cosmetic products and ingredients do not require FDA approval before they go on the market. The exception is color additives (other than those used in most hair dyes). Companies and individuals who market cosmetics have the legal responsibility to ensure the safety of their products.

To learn more, see FDA Authority Over Cosmetics.

Safety Data and Its Limitations

 

FDA can only act after a cosmetic is on the market and then must first establish that the product is harmful to consumers when used as intended. The agency has ways to monitor these products but even so, the information is often limited:

• Voluntary Cosmetic Registration Program: FDA encourages cosmetic firms to report product formulations through the VCRP. The VCRP database provides important information on these cosmetics. However, the companies are not legally required to tell FDA about their products and safety data.
• Inspections: FDA can inspect manufacturing facilities to determine if proper controls and practices are being followed. FDA also works with U.S. Customs and Border Protection to examine imported cosmetics. But because resources are limited, only a few establishments are inspected each year, and just a fraction of imports are physically examined.
• Surveys of products: FDA periodically buys cosmetics and analyzes them, especially if aware of a potential problem. The information obtained can be used to alert consumers, support regulatory actions, or issue guidance for industry. FDA does not have the resources to sample and analyze all cosmetics on the market.
• Cosmetic Ingredient Review (CIR) expert panel: The CIR is an independent, industry-funded panel of medical and scientific experts that meets quarterly to assess the safety of cosmetic ingredients. The limitations are that CIR bases its reviews on summaries provided by manufacturers, not the complete data sets from safety testing, and reviews only a limited selection of ingredients each year. FDA may or may not agree with CIR conclusions.

FDA’s Own Research

 

FDA conducts research on cosmetic products and ingredients to address safety concerns or to provide information to support regulatory actions or guidance. For example, the agency has conducted research on skin absorption of cosmetic ingredients, tattoo inks, and potential contaminants.

 

In considering the safety of a product, a number of factors are considered, such as:

• whether a cosmetic is likely to be inhaled, swallowed, or absorbed through the skin
• how often it is generally used
• how long it stays in contact with the body (for example, leave-on or wash-off)
• whether some people, such as children, the elderly, or people with compromised immune systems, might be more vulnerable than others 

FDA also looks for input from consumers and health care providers. If you experience a bad reaction to a cosmetic, please contact FDA’s problem-reporting program, MedWatch2, on the Web or at 1-800-332-1088; or contact the consumer complaint coordinator3 in your area.

 

Because the law does not require that bad reactions to cosmetics be reported to FDA, the agency may be unaware of problems. That's why FDA is trying to increase consumer awareness about the importance of reporting cosmetic-related problems. (See Bad Reaction to Cosmetics? Tell FDA.4)

  

What Can FDA Do if a Cosmetic Is Not Safe?

 

To prevent further shipment of a cosmetic that does not comply with the law, FDA may 

• ask a federal court to issue an injunction
• request that U.S. marshals seize the products
• initiate criminal action
• refuse entry of an imported cosmetic
• request that a company recall a product

FDA cannot require recalls of cosmetics, but works with companies to make sure their recalls are effective.

Changes in FDA's Management Structure - Message from the Commissioner to FDA Staff

Dear Colleagues,

I am writing today to let you know about some changes that I will be making to the agency’s management structure. As you probably recall, back in January, I told you that I was initiating a review of the Office of the Commissioner. As I explained at that time, this review was driven by the expanding and rapidly changing nature of the Agency’s responsibilities, and the need for a management structure that reflects these changes and best supports your efforts.

I consulted with former Commissioners, as well as with HHS Secretary Sebelius, and considered many options before arriving at the structure that I am announcing today.

The most important thing driving my consideration of this is the changing nature of both the Agency and the job of Commissioner.

Today, the Agency faces several key challenges:

First, we are a very large agency, with an incredibly broad span of responsibility. We regulate products that account for between 20 and 25 percent of every consumer dollar spent in the U.S. and that total more than a trillion dollars annually. For the most part, these are products that people rely on in fundamental ways every day.

Second, as technology and science continue to evolve, we are faced with the challenge of making sure that new ideas translate into the products and opportunities that people need and count on to protect their health. Innovative products that are truly transformative create unique scientific and regulatory challenges, and FDA must be a consistently powerful catalyst for innovation.

Third, we have seen the dramatic transformation of globalization – more products, more countries, more access by consumers and companies to global supplies – and this presents an enormous challenge to FDA in ensuring the safety and quality of the products we regulate.

Finally, we continue to be faced with administrative challenges. In these difficult economic times, our agency’s budget requires constant attention. And, simply providing the support and services for our 12,000 plus employees – everything from phones to IT to office space on our beautiful, growing White Oak campus – is a daunting job.

I take very seriously my responsibility to lead FDA along a path that will meet these challenges. One crucial part of this responsibility is to create a structure in the Commissioner’s Office that best supports your efforts and reflects the changing nature of the Agency.

The structure of the Office of the Commissioner that I inherited was created in 1970, when the FDA consisted of three Centers and a field office. By 2011, we had grown to seven Centers, and a Commissioner’s Office with more than 1,600 staff. Over the years, as Congress created new programs that cut across Center responsibilities, those programs were placed by default in the Office of the Commissioner.

The new organizational alignments more accurately reflect the agency’s responsibilities, subject matter expertise and mandates in an ever more complex world, where products and services do not fit into a single category.

Let me begin by saying that, for most of the FDA, this organizational alignment will likely not have a significant impact on you or your day-to-day work.

The most obvious change you will see is that the Agency’s programs, in terms of a reporting chain to me, will be divided into “directorates” that reflect the core functions and responsibilities of the Agency. This new management structure will enable the Office of the Commissioner to better support the agency’s core scientific and regulatory functions, and help tie together programs that share regulatory and scientific foundations. I will rely on the leadership of these directorates to help provide the necessary direction and coordination needed by an Agency of this scope.

I am establishing a new Deputy Commissioner for Medical Products and Tobacco, who will provide high-level coordination and leadership across the Centers for drug, biologics, medical devices, and tobacco products. The Centers will, of course, remain as discrete management entities under their current expert leadership. In addition to this strategic role with the Centers, this position will oversee our Special Medical programs.

I am pleased to announce that Dr. Steven Spielberg, former Dean of Dartmouth Medical School and currently Director of the Center for Personalized Medicine and Therapeutic Innovation at Children’s Mercy Hospital in Kansas City, has accepted this position. In this role, Dr. Spielberg will serve as both advocate and a support for Center Directors in their important work for FDA.

I will also be creating a directorate focused on grappling with the truly global nature of today’s world -- food and drug production and supply, as well as the science that undergirds the products we regulate -- so that the FDA can move from being a regulator of domestic products to one overseeing a worldwide enterprise.

To oversee this transformation, I have asked Deborah Autor, now Director of CDER’s Office of Compliance, to take on the role of Deputy Commissioner for Global Regulatory Operations and Policy. In this position, Deb will provide broad direction and support to the Office of Regulatory Affairs and to the Office of International Programs, with a mandate from me to make response to the challenges of globalization and import safety a top priority in the years to come. Dr. Murray Lumpkin, who has served with dedication and accomplishment as Deputy Commissioner for International Programs and Director of the Office of International Programs, will take on a new role as Senior Advisor and Representative for Global Issues. In this role, he will be charged primarily with special projects that draw on his expertise working with counterpart regulatory agencies on issues of global regulatory harmonization, governance and capacity-building.

The third directorate is the previously established Office of Foods, which we created to make our oversight of FDA’s food and feed program a more seamless enterprise. That task is even more important today as Mike Taylor leads the implementation of the Food Safety Modernization Act.

The fourth directorate will be a new Office of Operations, headed by a Chief Operating Officer. The COO will oversee the agency’s administrative functions, such as human resources, facilities, information technology, finance, and other activities that provide support to your organizations. Within this Office, I am bringing the budget formulation and budget execution functions together under a CFO position. We have initiated a search to fill the Chief Operating Officer position.

The Office of the Chief Scientist, charged with our important efforts to improve FDA’s science and address issues of cross-cutting scientific concern, will continue to do so. The National Center for Toxicological Research will report to the Chief Scientist, Dr. Jesse Goodman, and, like the other Centers, will remain a discrete management entity within this new directorate model.

Within the new, smaller, immediate office of the Commissioner, John Taylor will remain as Counselor and will have the additional responsibility to oversee the policy and planning functions, the Office of Legislation, and the Office of External Affairs. I want to thank John for serving as acting Principal Deputy these past months, in addition to his duties as Counselor. He has tirelessly supported me and the Agency with enthusiasm, energy, expertise, and good humor.

You can find revised organizational charts, reflecting this realignment at http://inside.fda.gov:9003/AboutFDA/FDAStaffInformation/OrgCharts/default.htm. In addition, I will share a video message of this announcement shortly. Your managers will be available to answer any questions you might have in the coming days.

In closing, I want to take a moment to thank you so much for all that you do. FDA is an extraordinary place, with so many highly-dedicated professionals and support staff who are committed to promoting and protecting public health. You accomplish a tremendous amount every day and I am grateful for all of your work. These organizational changes are intended to help further your important work and the mission of this remarkable Agency.

Sincerely,


Margaret A. Hamburg, M.D.

Commissioner of Food and Drugs