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Treasury Announces Largest North Korean Sanctions Package Targeting 56 Shipping and Trading Companies and Vessels to Further Isolate Rogue Regime - U.S. Department of the Treasury

WASHINGTON – The U.S. Department of the Treasury’s Office of Foreign Assets Control (OFAC) today announced the largest North Korea-related sanctions tranche to date, aimed at disrupting North Korean shipping and trading companies and vessels to further isolate the regime and advance the U.S. maximum pressure campaign.  Today’s action targets one individual, 27 entities, and 28 vessels located, registered, or flagged in North Korea, China, Singapore, Taiwan, Hong Kong, Marshall Islands, Tanzania, Panama, and Comoros.  Today, Treasury, along with the U.S. Department of State and U.S. Coast Guard, also issued an advisory alerting the public to the significant sanctions risks to those continuing to enable shipments of goods to and from North Korea.

“Treasury is aggressively targeting all illicit avenues used by North Korea to evade sanctions, including taking decisive action to block the vessels, shipping companies, and entities across the globe that work on North Korea’s behalf.  This will significantly hinder the Kim regime’s capacity to conduct evasive maritime activities that facilitate illicit coal and fuel transports, and erode its abilities to ship goods through international waters,” said Treasury Secretary Steven Mnuchin.  “The President has made it clear to companies worldwide that if they choose to help fund North Korea’s nuclear ambitions, they will not do business with the United States.”

These designations are consistent with the North Korea Sanctions Policy and Enhancement Act of 2016 as well as the Countering America’s Adversaries Through Sanctions Act of 2017, which provide broad designation criteria for certain trade and for providing certain shipping- and vessel-related services.

As a result of today’s action, any property or interests in property of the designated persons in the possession or control of U.S. persons or within the United States must be blocked, and U.S. persons are prohibited from dealing with any of the designated parties.

OFAC Issues Global Shipping Advisory: read further
New Label on Polyester Clothing Would be Required Under California Bill - California State Assembly

AB 2379, as introduced, Bloom. Waste management: polyester microfiber.

The Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65) prohibits any person, in the course of doing business, from knowingly and intentionally exposing any individual to a chemical known to the state to cause cancer or reproductive toxicity without giving a specified warning, or from discharging or releasing such a chemical into any source of drinking water, except as specified. Existing law prohibits the sale of expanded polystyrene packaging material by a wholesaler or manufacturer unless that material is composed of 100% recycled material. Existing law prohibits a person from selling a plastic product in this state that is labeled with the term “compostable,” “home compostable,” or “marine degradable” unless, at the time of sale, the plastic product meets the applicable ASTM International standard specification. Existing law prohibits, on and after January 1, 2020, a person, business, or other entity from selling or offering for promotional purposes in this state a personal care product containing plastic microbeads, as specified.

This bill would require that clothing made from fabric that is more than 50% polyester bear a conspicuous label stating that the garment sheds plastic microfibers when washed and recommending hand washing. The bill would prohibit a person, on and after January 1, 2020, from selling or offering for sale clothing made from fabric that is more than 50% polyester that does not bear that label.

Vote: MAJORITY Appropriation: NO Fiscal Committee: NO Local Program: NO

The people of the State of California do enact as follows:

SECTION 1. (a) The Legislature finds and declares all of the following:

(1) Microfiber is a subcategory of microplastic that is shed from synthetic fabric when that fabric is washed.

(2) These small, nondegradable fibers that are less than 5 millimeters in length are a major category of plastic pollution in water, pose a serious threat to the environment, and have been found within fish and shellfish that are consumed by humans.

(3) Garments made from synthetic fabrics, such as polyester, can shed up to 1,900 microfibers per wash.

(4) Polyester is the most widely used fiber in the textiles industry and accounts for about 50 percent of the total fiber market.

(5) Effluent from washing machines and wastewater treatment plants is a significant source of microfiber pollution that enters waterways and the ocean.

(b) It is therefore the intent of the Legislature to do both of the following:

(1) Recognize the emerging threat that microfibers pose to the environment and water quality and provide information to the general public about the sources of microfiber pollution.

(2) Reduce the amount of microfiber that enters the environment and is subsequently consumed by wildlife.

SEC. 2. Chapter 6 (commencing with Section 42368) is added to Part 3 of Division 30 of the Public Resources Code, to read:

CHAPTER 6. Microfiber Pollution Education and Reduction

42368. For purposes of this chapter, the following definitions apply:

(a) “Clothing” means an article of apparel intended to be worn by a person, not including hats or shoes.

(b) “Plastic microfiber” means a small polyester particle that is fibrous in shape, less than 5 millimeters in length, and is released into water through the regular washing of polyester-based textiles.

42369. (a) Clothing made from fabric that is more than 50 percent polyester shall bear a conspicuous label that states: “This garment sheds plastic microfibers when washed. Hand washing recommended.”

(b) On and after January 1, 2020, a person shall not sell or offer for sale clothing made from fabric that is more than 50 percent polyester, unless the clothing is labeled in accordance with this section.

In the News: 

The U.S. International Trade Commission (USITC) has voted to institute an investigation of certain fuel pump assemblies having vapor separators and components thereof. The products at issue in the investigation are certain fuel pump assemblies for marine engines, and in particular that are sold as equivalents or replacements for certain Volvo Penta fuel pump assemblies.

The investigation is based on a complaint filed by Carter Fuel Systems, LLC, of Logansport, IN, on January 31, 2018. The complaint was supplemented on February 15, 16, and 22, 2018. The amended complaint alleges violations of section 337 of the Tariff Act of 1930 in the importation into the United States and sale of certain fuel pump assemblies having vapor separators and components thereof that infringe a patent asserted by the complainant. The complainant requests that the USITC issue a limited exclusion order and a cease and desist order.

The USITC has identified Wenzhou Jushang (JS) Performance Parts Co. Ltd. of Wenzhou, Zheijhang, China, as the respondent in this investigation.

By instituting this investigation (337-TA-1101), the USITC has not yet made any decision on the merits of the case. The USITC’s Chief Administrative Law Judge will assign the case to one of the USITC’s administrative law judges (ALJ), who will schedule and hold an evidentiary hearing. The ALJ will make an initial determination as to whether there is a violation of section 337; that initial determination is subject to review by the Commission.

The USITC will make a final determination in the investigation at the earliest practicable time. Within 45 days after institution of the investigation, the USITC will set a target date for completing the investigation. USITC remedial orders in section 337 cases are effective when issued and become final 60 days after issuance unless disapproved for policy reasons by the U.S. Trade Representative within that 60-day period.

Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA's Ongoing Efforts to help Improve Effectiveness of Influenza Vaccines - Food & Drug Administration

The current influenza season has been especially difficult, causing widespread illness that has affected all fifty states and resulted in a record number of hospitalizations. While healthcare professionals continue to combat this year’s flu – which may continue to affect Americans into April – we’re already partnering with other public health agencies to conduct essential work to produce next season’s influenza vaccines.

As part of this process, we’re striving to better understand why we saw reduced effectiveness of this year’s influenza vaccines against one strain of influenza A, called H3N2. It was this strain that caused much of the influenza-related illness this flu season. Moreover, this year is not the first time we have seen vaccines be less effective against this particular strain of influenza, H3N2.

As such, we are taking a number of actions to better understand why effectiveness tends to be lower against the H3N2 strain and what we can do about it. By looking closely at the available data and applying the lessons we learn each flu season to the vaccine development process, we offer the greatest chance of developing vaccines that even more effectively prevent the flu in the future.

These lessons may be applied not only to enhancing the most prevalent process for developing influenza vaccine in eggs, but to considering whether greater investment in alternative processes such as cell-based or recombinant approaches to vaccine development are required. With this statement, I want to outline what we’ve learned so far about this season’s vaccines and the steps we’re taking and plan to take to determine the root cause of this year’s findings and better prepare for future flu seasons.

Reduced effectiveness of 2017-2018 seasonal vaccines against H3N2

There are a number of theories on why this season’s vaccines produced reduced effectiveness against H3N2. We’re taking steps to investigate each of these potential causes, rule out possible reasons for the variation in effectiveness and improve vaccine efficacy against H3N2. Overall, preliminary vaccine effectiveness reported by Centers for Disease Control and Prevention (CDC) for H3N2 influenza was 25 percent, which means that people who received the vaccine were 25 percent less likely to be sick and need to see a doctor.

While that finding isn’t too far off from the vaccine effectiveness seen against H3N2 in previous years, we need to take new steps to improve vaccine efficacy against H3N2. Of note, the effectiveness of the vaccine against H3N2 in children 6 months to 8 years of age was 51 percent this season, yet the effectiveness in those 65 years and older was only 17 percent, and the effectiveness in older children and adults under 65 years of age was even lower. The vaccines did do much better for other viruses that are also causing the flu this season. The data show that overall vaccine effectiveness for H1N1 and influenza B was 67 percent and 42 percent, respectively, for all age groups combined.

So why did this season’s vaccines not deliver higher protection against H3N2? And why have vaccines in prior seasons when H3N2 circulated, also delivered reduced protection against this particular flu strain?

We don’t think it was a question of getting the particular H3N2 strain wrong when we set out to produce this season’s flu vaccines. Although adapting circulating virus strains for manufacture can lead to differences between the circulating strain and the one used for manufacturing that could affect effectiveness, so far the data we have suggests that the viruses provided by reference laboratories to manufacturers to make this year’s vaccines do reasonably match the circulating flu strains that are causing most of the illnesses, including H3N2.

However, we’re working with our colleagues at CDC and other federal agencies to examine and address other factors that might be contributing to the less than optimal overall protection provided by this season’s vaccines against influenza. We would particularly like to understand why vaccine effectiveness against H3N2 influenza year-to-year tends to be lower than effectiveness against other influenza viruses.

Working to determine the root causes

Toward these ends, scientists at FDA are collaborating with colleagues at Centers for Medicare and Medicaid Services (CMS) to use a large database that includes details of the flu vaccines administered to four million individuals along with whether they were hospitalized for influenza or treated with antiviral medications for influenza-like illness. This work, which is still underway, will try to better understand why overall effectiveness with both the cell-based and egg-based vaccines was less than optimal. We’re also looking at the difference in effectiveness in people 65 years and older who were vaccinated with high-dose influenza vaccine and adjuvanted influenza vaccine to see if effectiveness was better than in those vaccinated with standard dose vaccines. The adjuvanted influenza vaccine contains an ingredient meant to boost the immune system’s response to the vaccine while high dose vaccines contain four times as much of the influenza material or antigen as standard vaccines. What we learn about the differences in efficacy between these different vaccines might reveal information that can inform why overall effectiveness against H3N2 was lagging.

What might this information reveal? One theory is that people might require a higher amount of H3N2 antigen to elicit a proper immune response to that particular strain of influenza. As I noted previously, the work conducted with CMS shows a preliminary finding that suggests the cell-based influenza vaccine might be somewhat more effective than the egg-based vaccine. We are working to follow up on that finding. We’re also combing through the data to see if there are other reasons for why this season’s vaccines were less effective against H3N2. Our scientists are currently working internally and collaborating with others inside and outside of the federal government to understand all of these findings.

The knowledge we gain through such scientific research will allow us to determine if we need to change recommendations to vaccine manufacturers for how future season’s vaccines should be produced.

Looking ahead to the 2018-2019 flu season

While this scientific work is underway, the composition of next season’s flu vaccines will be the subject of an FDA advisory committee meeting March 1, 2018. As is done every year, the FDA convenes this panel to consider the recommendations made by the World Health Organization (WHO) regarding the composition of influenza vaccines for the Northern Hemisphere, and to help the FDA select strains for next season’s flu vaccines in the U.S. WHO has recommended changing two of the strains currently contained in this year’s influenza vaccines for the Northern Hemisphere. The upcoming FDA advisory committee meeting will determine if these recommendations should also apply for the U.S. Following that meeting, the FDA will also work to apply all the knowledge that we gain from this year’s flu season to ensure that the best possible vaccines are available next season to protect against the flu.

In the meantime, this flu season isn’t over yet, though CDC data shows a decline in visits to doctor’s offices and outpatient clinics. We must continue to be diligent in doing our part to prevent the spread of flu however possible, including remembering to wash your hands frequently and staying home when you are sick. It’s also not too late get vaccinated if you have not yet done so, given that we are starting to see a larger proportion of illnesses caused by H1N1 and B influenza for which vaccines offer better protection. Vaccinations have also been shown to reduce the severity of the flu in people who get sick. People who are very sick with flu-like symptoms and those who are at high risk of serious flu complications should see a healthcare professional as soon as possible to see if they should be treated with antiviral drugs.

The FDA remains committed to determining the root cause for the shortcomings observed in the effectiveness of this season’s flu vaccine against H3N2, notifying the public of our work as we gain new insights, and applying what we learn to future vaccine development. Our aim is to make sure we continue to improve the effectiveness of future flu vaccines, and encourage more people to seek vaccination.

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
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