C-AIR TIMES ISSUE #680 - Friday, April 30, 2021 08:06

POLA and POLB Marine Terminal Gates Closed Thursday, May 6, 2021, from 5 p.m. - PierPass

PierPass Inc. has been notified that the International Longshore and Warehouse Union (ILWU) will observe a special stop work meeting for union business on Thursday, May 6, 2021, starting at 5 p.m. As a result, no marine terminal gates at the Port of Los Angeles or the Port of Long Beach will operate between the hours of 5:00 p.m. on May 6 through 3:00 a.m. on May 7. There will be no OffPeak shift Thursday night May 6.

Please check with individual terminals for substitute or alternative gates.

This labor shutdown falls under Rule 5 of the Marine Terminal Operator Schedule No. 1, which is available at:

https://www.pierpass.org/wp-content/uploads/2021/03/WCMTOA-MTO-Schedule-2021-03-06.pdf

Federal Register Notices:

PEMBINA, N.D. — U.S. Customs and Border Protection Agriculture Specialists (CBPAS) issued 214 emergency action notifications during the first quarter of 2021. Emergency Action Notifications (EAN) alert trade entities of non-compliance with Animal and Plant Health Inspection Service (APHIS) regulations. The EAN provides options for phytosanitary actions that must be taken to prevent the entry of plant pests, prohibited plant products, or animal products capable of introducing foreign animal diseases.

During an inspection of a rail container in International Falls, Minnesota, CBPAS intercepted a Longhorn beetle in a shipment of flower steel hardware washers from China. According to APHIS, the Longhorn beetle is a destructive pest of wood, causing millions of dollars of damage annually to the timber industry. The container was returned to China.

CBPAS in Portal, North Dakota found Mikania Micrantha Kunth, commonly known as “mile-a-minute vine”, within a shipment of hardware fittings from Malaysia. According to APHIS, the vine covers plants, shrubs, and trees may cause hepatoxicity and liver damage in dairy cattle. The container and contents were returned to Malaysia.

CBPAS in Pembina, North Dakota discovered a shipment of organic Fonio seed from Mali. Fonio is a small cereal grain belonging to the millet family. The shipment had weed contamination. Fortunately, the contaminants were found to pose no threat. The shipment was released.

“These agriculture seizures show the significant priority Customs and Border Protection places on our agriculture inspection program at our ports of entry,” said Pembina Area Port Director Jason Schmelz. “Preventing harm to domestic crops and vegetation is an important role our Agriculture Specialists provide this country.”

CBP Agriculture Specialists are the front line in the fight against the introduction of harmful insects and diseases into the U.S. They safeguard American agriculture by stopping plant pests and exotic foreign animal diseases that could harm vital agriculture resources at our nation’s borders.

During a typical day last year, CBP agriculture specialists across the nation seized 3,091 prohibited plant, meat, animal byproducts, and soil, and intercepted 250 insect pests at U.S. ports of entry. See what else CBP achieved on a typical day during 2020.

CBP Officers in Cincinnati Seize $4.26 Million in Fake Jewelry - U.S. Customs & Border Protection

CINCINNATI — On April 26, U.S. Customs and Border Protection (CBP) officers in Cincinnati seized 9,377 pieces of jewelry from a shipment originating in China and destined to an address in McAllen, Texas.

Officers inspected the shipment on March 30 and found thousands of jewelry items bearing protected trademarks from Tiffany, Pandora, Cartier, Bvlgari, Dior, Gucci, Chanel, Rolex, Versace, and Tous. Unprotected “generic” jewelry was comingled in the same box with protected jewelry that was undervalued on the invoice. Officers reached out to CBP’s Centers of Excellence and Expertise (CEE), and an import specialist determined the jewelry was counterfeit. Had they been genuine, the items would have been worth more than $4.2 million although the declared value was only $119.

“Intellectual property theft harms the U.S. economy and threatens the security, health, and safety of the American people,” said Cincinnati Port Director Richard Gillespie. “Our officers are committed to protecting private industry and consumers and ensuring that legal trade continues to power our economy.”

CBP has established an educational initiative to raise consumer awareness about the consequences and dangers that are often associated with the purchase of counterfeit and pirated goods. Information about the Truth Behind Counterfeits public awareness campaign can be found at
https://www.cbp.gov/FakeGoodsRealDangers.

Intellectual property rights (IPR) protection is a priority trade issue for CBP. In Fiscal Year (FY) 2019, CBP and their partner agency Homeland Security Investigation (HSI) seized 27,599 shipments containing IPR violations with a manufacturer’s suggested retail price (MSRP) of over $1.5 billion had the goods been genuine. Watches and jewelry represent 15 percent of all IPR seizures and continue to top the list of all seized IPR materials.

CBP conducts operations at ports of entry throughout the United States, and regularly screens arriving international passengers and cargo for narcotics, weapons, and other restricted or prohibited products. CBP strives to serve as the premier law enforcement agency enhancing the Nation’s safety, security, and prosperity through collaboration, innovation, and integration.

Consumers Should Spring into Safety with the “New Normal” - Consumer Product Safety Commission

Washington, D.C. – As COVID-19 continues to shape our “new normal,” consumers are reminded to maintain social distancing and wear protective masks when in public or group settings. And now with spring upon us, flowers in the garden are not the only things blooming. Milder temperatures mean more of us will head outdoors for recreation and do-it-yourself home projects involving power tools, yard equipment and sports gear. The U.S. Consumer Product Safety Commission (CPSC) encourages consumers to remain vigilant about avoiding hazards while at home, at play or at school. Whatever the activity, CPSC cautions consumers, always Do It Safely (D-I-S), and heed the following tips:

Keep children and pets at a safe distance when using power tools, lawn mowers, ladders, and electric or motorized recreational devices.
Wear snug clothing, and remove jewelry or other accessories that might get caught in tools or machinery, and keep hands away from moving parts.
Wear safety goggles to protect your eyes from flying debris.
When using table saws, be extra cautious. Always use the fence for rip cuts and the miter gauge for cross cuts. NEVER cut “free hand.” Incorrect guiding of the workpiece is a major cause of kickback and blade-contact injuries.
Make sure all tools and machinery are in good condition or serviced, as needed. Register equipment for warranty coverage and safety updates. Check for possible recalls at saferproducts.gov.
When engaged in activities that require a ladder (such as gutter cleaning, painting, and home repairs) – BEFORE you climb: place the ladder’s feet on solid and level ground to avoid falls, and be sure to have another adult on site who can act as a “spotter.”
Keep ladders away from power lines and live wires to prevent electrocution.
For more tips on staying safe when engaged in outdoor repairs, spring into action here.

Kids back in school?

When playing sports, make sure to wear a helmet and other protective gear meant for that sport to prevent injuries. For more helmet tips, spring into action here.
Is there a 3D printer at school? Be aware of possible hazards, such as burns, electric shocks and exposures to additives or chemicals that can affect indoor air quality. Make sure there is proper ventilation for the printer.

Kids still home?

As reflected in CPSC's COVID injuries report, emergency room-treated injuries rose for a number of products during the first seven months of the pandemic. Increased incidents included unintentional poisonings related to cleaning agents, soaps and detergents and injuries related to skateboards, scooters, hoverboards and ATVs.

Be sure to:

Keep laundry and cleaning products stored in their original containers, locked up and away from children.
Wear a helmet when riding a bike, skateboard or scooter. The proper helmet can significantly reduce the risk of head injury in the event of a fall.
For more safety tips when playing outdoors, spring into action here.

Throughout the pandemic, CPSC has provided consumers with safety tips and information that can be found at our COVID-19 Safety Education Center. Remember, whatever the activity, Do It Safely.

FDA Takes Action For Failure to Submit Required Clinical Trial Results Information to ClinicalTrials.Gov - Food & Drug Administration

Being transparent about the results of completed clinical trials enables important advances in the development of medical products and helps ensure a safe, effective and efficient clinical research enterprise. Across all types of medical product trials, the U.S. Food and Drug Administration works with responsible parties to encourage compliance with the requirements to submit registration and summary results information to the ClinicalTrials.gov data bank, managed by the National Institutes of Health (NIH)/National Library of Medicine.

Sponsors of clinical trials may represent a variety of organizations, including academic institutions, hospitals, private companies and government research organizations, or could be individual researchers. Federal law requires that responsible parties, typically trial sponsors, register applicable clinical trials on ClinicalTrials.gov within 21 days after the first human subject is enrolled and submit certain summary results information for those trials, generally no later than one year after the study’s completion date unless a deadline extension is obtained.

The FDA makes determinations about whether responsible parties are complying with legal requirements for submitting information to ClinicalTrials.gov for applicable clinical trials. These statutory and regulatory requirements are intended to provide greater transparency regarding clinical trials, ultimately allowing the broader scientific community to build on the information submitted. The submission to and posting of clinical trial information on ClinicalTrials.gov honors volunteers who participate in research to advance medical science and enhances public trust by creating a transparent and robust public record of clinical trials and information about their results. When these legal requirements are not met, the FDA has the authority to take enforcement action.

The agency has previously outlined its approach to identifying whether responsible parties have failed to submit required registration and/or summary results information to the ClinicalTrials.gov data bank for applicable clinical trials studying drug products, biological products and device products. Although many responsible parties comply with the law without FDA action, the agency has sent Pre-Notices of Noncompliance (more than 40 to date) to encourage voluntary compliance with the ClinicalTrials.gov requirements.

The FDA has determined that a responsible party who received a Pre-Notice of Noncompliance has not complied with its legal reporting obligations. Accordingly, today, the FDA issued its first Notice of Noncompliance to Acceleron Pharma, Inc. (Acceleron) for failing to submit required summary results information to ClinicalTrials.gov. The company’s applicable clinical trial evaluated the safety and effectiveness of the drug dalantercept in combination with axitinib in patients with advanced renal cell carcinoma. The Notice of Noncompliance gives Acceleron 30 days to submit the required summary results information. The FDA is authorized to seek civil money penalties for Acceleron’s violation, including additional civil money penalties if Acceleron fails to submit the required information within the 30-day period.

The Notice of Noncompliance has also been posted to the FDA’s website and information about the noncompliance will be posted on the study record on ClinicalTrials.gov by NIH. NIH will continue to update the ClinicalTrials.gov records for applicable clinical trials that are the subject of a Notice of Noncompliance with information regarding whether the noncompliance has been corrected and the amount of civil money penalties assessed, if any.

The FDA takes its role in enforcing the ClinicalTrials.gov registration and results information submission requirements extremely seriously and we will continue to encourage voluntary compliance with these requirements. When necessary, the FDA will take appropriate actions to help ensure that required information is available on ClinicalTrials.gov as required by law and for the benefit of clinical trial participants and public health.

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.

Maritime Administration Awards Nearly $20 Million in Funding to Strengthen U.S. Shipyard Economic Competitiveness - Department of Transportation

WASHINGTON – Today (4/26/21), the U.S. Department of Transportation’s Maritime Administration (MARAD) announced $19.6 million in grant awards to 31 small shipyards in 15 states through the Small Shipyard Grant Program. The funds will help awardees modernize, increase productivity, and expand local employment opportunities while competing in the global marketplace. Since 2008, MARAD’s Small Shipyard Grant Program has awarded $262.5 million to nearly 300 shipyards in 32 states and territories throughout the U.S.

“Small businesses are the backbone of the American economy, and small shipyards play a critical role in America’s maritime industry,” said U.S. Secretary of Transportation Pete Buttigieg. “These grants go directly to small shipyards across the country and will help protect and create local jobs, strengthen America’s maritime industry, and bolster our economic security.”

Small shipyards are essential parts of our maritime industrial base and employ thousands of Americans. They strengthen communities along and near our nation’s ports and waterways. Many small shipyards are family-run businesses—and they are all enterprises in which small investments can make big differences. MARAD’s Small Shipyard Grant Program supports economic competitiveness through grants that can be used to purchase equipment or train employees. In addition, the purchase of American-made manufacturing equipment made possible by Small Shipyard grants supports a wide range of jobs throughout our Nation’s manufacturing base.

“These grants will help small businesses do what they do best: build essential infrastructure while creating long-term jobs for American workers,” said Lucinda Lessley, Acting Maritime Administrator. “Better equipment means increased productivity and more ships moving through our small shipyards—and more ships mean more local jobs.”

A complete list of shipyard grant recipients here: