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CBP Takes Interim Measures for Transshipment of Glycine in Ongoing Enforce and Protect Act Investigation - U.S. Customs & Border Protection

As a result of the measures, CBP halts the potential evasion of several million dollars’ worth of antidumping duties annually

WASHINGTON – U.S. Customs and Border Protection issued a notice of interim measures on Dec. 4 to importer, Ceka Nutrition, Inc., in its ongoing Enforce and Protect Act (EAPA) investigation concerning the evasion of the antidumping duty order for glycine from The People’s Republic of China. CBP found a reasonable suspicion that Ceka Nutrition was entering glycine that had been transshipped from China through Cambodia.

“CBP is committed to aggressively pursuing allegations that we receive of duty evasion with all of the available legal tools we have at our disposal, as we did in this case,” said Acting Commissioner Kevin McAleenan. “Through partnering with the trade community in combating evasion, CBP can work to level the playing field for U.S. businesses by facilitating legitimate trade, while penalizing and deterring the violators of U.S. trade laws. To that end, I encourage those with knowledge of evasion of our trade laws to file an allegation with CBP.”

CBP has taken the following interim measures against Ceka Nutrition:

  • Requiring “live” entry for all imports of glycine, meaning Ceka Nutrition must submit proper import documentation and duties prior to the release of its merchandise;
  • Implementing rate adjustments for all unliquidated entries of merchandise subject to this investigation to reflect that they are subject to the antidumping duty order;
  • Suspending or extending unliquidated entries of glycine, as appropriate;
  • Rejecting any entry summaries that fall within the entry summary reject period; as well as,
  • Reviewing Ceka Nutrition’s continuous bond and application of single transaction bonds for it, as appropriate.

As a result of implementing EAPA interim measures, CBP halts the potential evasion of several million dollars’ worth of antidumping duties annually. The antidumping duty rate for goods subject to the China-wide rate for this order is 453 percent ad valorem.

GEO Specialty Chemicals, Inc., of Deer Park, Texas, filed an allegation on Aug. 1 claiming that Ceka Nutrition was evading the antidumping duty order on glycine from China. Geo Specialty Chemicals is one of the largest U.S. producers of glycine, and a petitioner for the antidumping duty order on glycine from China. The allegation provided evidence that reasonably suggested that Ceka Nutrition had imported glycine that was transshipped by LG Chemicals Ltd. from China through Cambodia.

CBP requested detailed information from Ceka Nutrition regarding its foreign supplier, and conducted an on-site visit of the alleged foreign supplier in Cambodia to assess the validity of the information provided by Ceka Nutrition. At that site visit, CBP learned from employees who operated the supplier’s purported factory that the facility only further refined Chinese-origin glycine and did not produce it, thus rendering it subject to the antidumping duty order on glycine from China. Moreover, there was insufficient equipment, product, and employees on hand to support claims that the factory could produce the quantity that had been exported to the United States in the prior year, further supporting CBP’s determination that this glycine was transshipped from China through Cambodia. The notice of final determination in this investigation is due on July 2, 2018.

For additional information on CBP and the Enforce and Protect Act, please visit CBP.gov. If you suspect an importer of duty evasion, CBP encourages you to submit an allegation through our online portal.


CBP Realigns Hours at Ports of Roseau and Lancaster - U.S. Customs & Border Protection

Effective Sunday, January 7, 2018, U.S. Customs and Border Protection (CBP) will adjust the hours of operation at the Lancaster and Roseau, Minnesota Ports of Entry (POE). Recently, CBP assessed workload volumes, staffing, and infrastructure costs at various northern border POEs. The Ports of Lancaster and Roseau were identified for modification of operational hours to realign resources to workload. This adjustment will allow CBP to properly align staffing with workload, maintain CBPs inspectional and enforcement missions, and redirect resources to ports with greater commercial and passenger volumes. Northbound travelers and cargo exports will not be affected by this change.

The current hours of operation for the Port of Lancaster are 8:00 a.m. to 10:00 p.m., which coincide with the hours of operation at the adjacent Canadian Port of Tolstoi, Manitoba. Effective January 7, 2018, the new hours of operation at Lancaster will be 8:00 a.m. to 6:00 p.m. in the winter and 8:00 a.m. to 8:00 p.m. in the summer. Travelers wishing to cross into the United States when the port is closed, may cross at Pembina, North Dakota, a 24-hour POE approximately 30 miles west of Lancaster.

The current hours of operation for the Port of Roseau are 8:00 a.m. to midnight, which coincide with the hours of operation at the adjacent Canadian Port of South Junction, Manitoba. Effective January 7, 2018, the new hours of operation at Roseau will be 8:00 a.m. to 8:00 p.m. year round. Travelers wishing to cross into the United States between the hours of 8:00 p.m. and 8:00 a.m. may cross at Warroad, Minnesota, a 24-hour POE approximately 21 miles east of Roseau.


USITC:  News Releases, New Documents, Announcements - US International Trade Commission

Takes only 11 months to best last year's 12-month total

With just under one month left in 2017, the Port of Long Beach has already exceeded the cargo total for all of last year, and will handle more than 7 million containers for only the fourth time in its 106-year history.

A total of 612,659 twenty-foot equivalent units moved through Long Beach in November, an increase of 14.7 percent over the same month a year ago. Through the first 11 months of the year, shippers have sent 6,847,589 TEUs across the Port’s docks, a 10 percent increase. The Port handled 6,775,171 TEUs in 2016.

“U.S. consumers are confident and the economy has been strong,” said Long Beach Harbor Commission President Lou Anne Bynum. “Retailers have been stocking goods as a result and we are nearing cargo levels we have not seen since before the 2008 recession.”

“Our focus on speed and reliability has positioned the Port to have its busiest year ever,” said Port of Long Beach Executive Director Mario Cordero. “I applaud all of our business partners for their contributions to our remarkable turnaround.”

Retailers making a last dash to stock goods for the holidays and after-Christmas sales helped imports surge 18 percent in November to 319,210 TEUs. Exports rose 4.5 percent, to 126,364 TEUs. Demand in Asia for empty containers grew that trade to 167,085 containers, up 17 percent.

The Port of Long Beach is one of the world’s premier seaports, a gateway for trans-­Pacific trade and a trailblazer in goods movement and environmental stewardship. With 175 shipping lines connecting Long Beach to 217 seaports, the Port handles $180 billion in trade annually, supporting hundreds of thousands of Southern California jobs.


FDA Launches New Tool for Sharing Information that Allows Doctors to Better Manage Antibiotic Use; Improve Patient Care - Food & Drug Administration

Today the U.S. Food and Drug Administration is announcing a new approach to get critical updates regarding antibiotics and antifungal drugs to health care professionals as part of an overall effort to combat antimicrobial resistance. The gency created a website that will provide direct and timely access to information about when bacterial or fungal infections are likely to respond to a specific drug. This approach is intended to aid health care professionals in making more informed prescribing decisions that will both benefit their patients and prevent the spread of resistant bacteria.

“Antimicrobial resistance remains one of our most pressing public health challenges. While we’re continuing our policy efforts to encourage the development of new drugs and limit the use of antibiotics in livestock, we also need to take new steps to encourage more appropriate use of these treatments in patient care,” said FDA Commissioner Scott Gottlieb, M.D. “When you’re treating critically ill patients, you want as much information as possible about the pathogen your patient is fighting and the susceptibility of that pathogen to various treatments. Prescribing a drug that’s only going to be met with resistance from the bacteria or fungus it’s intended to treat doesn’t help that patient, and it has broader public health consequences that cannot be ignored. Under the old approach, it took too long to update each individual drug’s labeling with information needed for susceptibility testing and it was clear a more centralized approach was needed. Our new tool is aimed at making this process more efficient and informed.”

Physicians can use antimicrobial susceptibility test (AST) results to help choose an appropriate antibacterial or antifungal drug to treat a patient’s infection. These tests rely on criteria — called susceptibility test interpretive criteria or “breakpoints” — that help determine whether a specific bacteria or fungi are susceptible to antibacterial or antifungal drugs. Bacteria and fungi change over time, which may result in decreased susceptibility to some drugs. When this occurs, breakpoints may need to be updated.

Under the old approach, each drug manufacturer updated its drug labeling with new breakpoint information, which had to be reviewed and approved by the FDA on a case-by-case basis. Only after the revised drug labeling was approved could a device manufacturer of a corresponding AST update its testing criteria and labeling for its AST. This process created unnecessary delay in reaching healthcare professionals with the information. Each individual drug and device labeling had to be updated whenever breakpoints changed.

The new approach, which was included by Congress as part of the 21st Century Cures Act, allows the FDA to simultaneously update the breakpoints for multiple drugs that have the same active ingredient and share that information transparently via a dedicated FDA web page that will list FDA-recognized breakpoints. The FDA will leverage the work done by standards-development organizations that develop breakpoints, and recognize them when the FDA agrees that they are appropriate. The FDA retains full authority to accept a standard in whole or in part, or to establish alternative breakpoints. In addition, companies can submit data to support alternative breakpoints, if they disagree with the recognized standard.

Drug manufacturers will have to update their labeling to reference the FDA web page containing the breakpoint information. They will no longer have to continuously update their labeling with new breakpoint information, making the process more efficient and, it is expected, more timely. As such, the FDA anticipates this effort will also ease the burden for both drug manufacturers and AST device developers. To support companies in this effort, today the FDA is also issuing guidance on how companies should update their labeling on breakpoints to point to the information online generated by the agency.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also 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.


FDA Warns Companies for Promoting Alternatives to Street Drugs - Food & Drug Administration

Coco Loko and Legal Lean Syrup found to be unapproved drugs

The U.S. Food and Drug Administration today posted a warning letter to the marketers and distributors of Legal Lean Syrup, a drink, and Coco Loko, a “snortable” chocolate powder, for selling unapproved new drugs and misbranded drugs.

The warning letter explains how the claims made in the promotional materials for Legal Lean Syrup and Coco Loko demonstrate that the products are intended to be used as alternatives to illicit street drugs and that the products, as labeled and marketed, may pose safety concerns. Drug abuse is a serious public health issue, and the FDA is concerned that products like Legal Lean Syrup and Coco Loko encourage drug abuse in individuals, including minors. Street drug alternatives are products that claim to mimic the effects of recreational drugs and are intended to be used for recreational purposes to affect psychological states.

“As a physician and a parent, I’m deeply troubled by the unlawful marketing of these potentially dangerous products, especially since they are so easily accessible by minors. Encouraging the use of snortable chocolate as an alternative to illegal street drugs is not acceptable – there are very real consequences to snorting any powder, not to mention the societal dangers of promoting drug abuse,”’ said FDA Commissioner Scott Gottlieb, M.D. “At a time where drug addiction is threatening the fabric of American society, we must take action when we see efforts that may further fuel illicit drug abuse. We’ll continue to vigorously target bad actors that sell unapproved products, including products that contain undeclared drug ingredients.”

Coco Loko is described as a “snuff” and promoted to be “snorted” (inhaled intranasally). Intranasal administration of a powder substance can trigger spasms of the vocal cords making it difficult to speak or breathe (laryngospasm) or tightening of the muscles that line the airways in the lungs (bronchospasm) and may also induce or exacerbate asthma. The ingredients listed on the product label for Coco Loko also include taurine and guarana, neither of which have been evaluated for intranasal administration.

An FDA laboratory analysis found that Legal Lean Syrup contained the active pharmaceutical ingredient doxylamine, which was not included in the product labeling. FDA-approved products that contain doxylamine warn against its use with alcoholic beverages and instruct people with certain medical conditions to consult a physician before use. Furthermore, the inclusion of undeclared doxylamine in Legal Lean Syrup poses a potentially serious risk to those who have already had adverse reactions to this ingredient and whose physicians have advised them to avoid it. In general, products that contain undeclared drug ingredients pose a serious health risk, because consumers with underlying medical issues may take the products without knowing of any potential side effects or interactions.

The FDA has requested that Arco Globus Trading LLC (dba Arco Globus International), Legal Lean LLC and LegalLeanStore.com respond to the FDA within 15 working days and include a statement of how the issues noted in the warning letter will be corrected. The warning letter also states that failure to correct violations may result in regulatory action such as seizure or injunction.

Health care professionals and consumers should report any adverse events related to these products to the FDA’s MedWatch Adverse Event Reporting program. To file a report, use the MedWatch Online Voluntary Reporting Form. The completed form can be submitted online or via fax to 1-800-FDA-0178.

The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, 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.


Enjoy your Holiday Laser-light Display-Responsibly - Consumer Product Safety Commission

Each holiday season for the past several years, the Federal Aviation Administration (FAA) has received reports from pilots who said they were distracted or temporarily blinded by residential laser-light displays.

The FAA's concerns about lasers – regardless of the source – is that they not be aimed at aircraft in a way that can threaten the safety of a flight by distracting or blinding the pilots. People may not realize that systems they set up to spread holiday cheer can also pose a potential hazard to pilots flying overhead.

So if you’re going to install a holiday laser-light system, please make sure the lights are hitting your house and not shining up into the sky. It may not look like the lights go much farther than your house, but the extremely concentrated beams of laser lights actually reach much further than most people think.

If the FAA becomes aware of a situation where a laser-light display affects pilots, we start by asking the owner to adjust them or turn them off. However, if someone's laser-light display repeatedly affects pilots despite previous warnings, that person could face an FAA civil penalty.

 

 
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