Oyster growers request permit to use imidacloprid in Willapa Bay and Grays Harbor
PRESS RELEASE ISSUED 9/ 18/ 17 (link source)
OLYMPIA – Oyster growers have requested a new permit from the Washington Department of Ecology to use the pesticide imidacloprid on burrowing shrimp in Willapa Bay and Grays Harbor. Before considering the permit, Ecology has assessed the potential environmental impacts from the use of the pesticide on tidelands.
Ecology has compiled its findings in a formal report, officially referred to as a Draft Supplemental Environmental Impact Statement, and is seeking public review and feedback through Nov. 1, 2017. Two public meetings have been scheduled in October – one in South Bend and one in Olympia.
The Willapa Grays Harbor Oyster Growers Association (WGHOGA) has specifically applied for a water quality pollution discharge permit and a sediment impact zone authorization. The current proposal is similar – but not identical – to the one submitted by WGHOGA to use imidacloprid in 2015. The applicants propose treating less acreage – 485 acres in Willapa Bay and 15 acres in Grays Harbor – as opposed to 2,000 acres across the two bays in the previous permit. They also propose in this application to treat tidelands with hand or ground equipment as opposed to aerial spraying. The original permit was withdrawn at the growers’ request in May 2015 and never used.
As part of the environmental review process for the current application, Ecology has considered and evaluated new research and analyses that were not available during the previous environmental review. This supplemental review incorporates the most current scientific information available into the full Environmental Impact Statement that was originally adopted in 2015.
Ecology’s supplemental environmental review highlights:
Immediate adverse, unavoidable impacts to juvenile worms, crustaceans, and shellfish in the areas treated with imidacloprid and the nearby areas covered by incoming tides.
Limited impacts bay-wide, but significant uncertainty about the cumulative impacts and other unknown impacts, including those to other marine invertebrates and lifecycles.
Little direct risk to fish, birds, marine mammals, and human health.
Potential indirect impacts to fish and birds if food sources are disrupted.
Continued knowledge gaps about imidacloprid. Further research is needed.
The agency will use information gathered during the public comment period to finalize the Supplemental Environmental Impact Statement. This is a crucial step in Ecology’s environmental review required under the State Environmental Policy Act (SEPA). Ecology will rely on this environmental review and public input to help determine whether to develop a draft permit approval for further public comment or deny the permit application.
OUR HEALTH AND ENVIRONMENT
Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s immediate steps to respond to Hurricane Maria and ongoing recovery efforts related to Hurricane’s Harvey and Irma
PRESS RELEASE ISSUED 9/ 22/ 17 (link source)
As the citizens of Puerto Rico and the U.S. Virgin Islands begin the long recovery effort from the devastation brought by Hurricane Maria, I know I’m joined by all of my colleagues at the Food and Drug Administration in keeping the residents of all these islands in our thoughts. I also want to extend my thanks to the FDA staff in our San Juan office who worked hard to prepare and secure our facilities ahead of the storm.
There are many challenges ahead, but much of the hurricane response over the next few days will rightly focus on life-saving measures. The agency stands ready to support the federal government’s overall response in whatever way we can—be it providing support through our U.S. Public Health Service Commissioned Corps officers, or FDA’s civilians who have volunteered to support the efforts led by the Department of Health and Human Services and the Federal Emergency Management Agency (FEMA).
Over the past few weeks, hundreds of dedicated FDA experts have also been working closely with the agency’s leadership to ensure a timely and impactful response on Hurricanes Harvey and Irma. We stand ready to provide that same assistance to communities impacted by Hurricane Maria. Initial assessments indicate that it may be months before all of Puerto Rico has power restored, compromising the critical infrastructure of the island. As the relief effort moves into recovery, we are committed to working closely with local and federal partners, as well as the food and medical product industries, to address the immediate and long-term consequences of the storm.
Like many federal agencies, the FDA has an important role to play by ensuring the safety of, among other things, medical products, blood, and the food supply—all of which have the potential to be destroyed or become contaminated by flood waters, further jeopardizing the health and safety of Americans.
Our efforts are multifaceted. Since the onset of the storms—beginning with Harvey—the agency has been working to provide recommendations and communicate about how to handle food and medical products that may have been impacted by the storms. This information is important to the people who use them as well as the industry that produces them, and is aimed at avoiding unnecessary illnesses, avoiding wasting good medicines, preventing drug and food shortages, and addressing crop losses.
These storms have hit hard in areas where there are a significant number of farmers, food distributors, and medical product manufacturers, including Houston, Florida, and now Puerto Rico and the U.S. Virgin Islands. The agency has been working to identify the firms in the path of these storms and coordinate with them to assess the impact on their facilities to avoid—where possible—shortages of critical medical products and food. In fact, we identified and have begun outreach to approximately 10,000 firms potentially impacted by Hurricanes Harvey and Irma. Thankfully, to date no critical shortages have been identified in areas impacted by Harvey and Irma. The FDA is currently working closely with pharmaceutical and device companies with manufacturing sites in Puerto Rico to prevent shortages of medically necessary drugs and devices.
Another critical area is ensuring access to safe blood in the face of so many storm-related injuries. Since the storms’ onset, my colleagues have been working closely with the AABB Interorganizational Task Force to help ensure that not only are needs being met, but that we maintain the same level of blood safety as we do when we are not amidst three natural disasters. Thanks to the continued donations, blood banks have successfully met the needs across all impacted regions in the continental U.S. to date, and this important group will continue to monitor the needs in the Puerto Rico and the U.S. Virgin Islands.
I deeply appreciate the work of all FDA staff responding to these disasters, including the approximately 350 FDA staff who have deployed or are ready to deploy as part of the U.S. Public Health Service Commissioned Corps, and those who put in many additional hours in support of FDA’s response in addition to other mission-critical work at the agency. I am proud of their work and dedication to helping ensure that we are doing as much as possible to help our fellow Americans. I was incredibly moved by the more than 150 FDA civilian staff who responded to FEMA’s request for volunteers. My staff and I are fully committed in our support of the nation’s efforts to recover and rebuild over the months that follow.
FDA: Criminal and civil actions filed against Aegerion Pharmaceuticals Inc.
PRESS RELEASE ISSUED 9/ 22/ 17 (link source)
Today, Aegerion Pharmaceuticals Inc. agreed to plead guilty in the United States District Court for the District of Massachusetts to two misdemeanor counts of violating the Federal Food, Drug, and Cosmetic Act (FD&C Act) involving the introduction of misbranded Juxtapid (lomitapide) into interstate commerce. In connection with this agreement, the criminal information filed today charged that Juxtapid was misbranded because Aegerion failed to comply with the requirements of the Juxtapid Risk Evaluation and Mitigation Strategy (REMS) program and because the drug’s labeling lacked adequate directions for all of Juxtapid’s intended uses. This agreement resolves a criminal investigation in which the U.S. Food and Drug Administration’s Office of Criminal Investigations played an important role.
Aegerion and one of its senior vice presidents, Charles M. Gerrits, PharmD, Ph.D also agreed to enter into a consent decree of permanent injunction with the United States. The consent decree includes a comprehensive compliance program and legal tools for the FDA to ensure that the defendants comply with the law, subject to judicial oversight. The FDA’s Center for Drug Evaluation and Research was instrumental in crafting the compliance obligations agreed to in the consent decree.
“We sometimes require companies to put in place certain measures to more closely manage a drug’s risks when we don’t believe a medicine’s benefits would outweigh its side effects without these risk mitigation strategies. This might include requiring prescribers to undergo certain training on a drug’s risks, or having providers take steps to more closely monitor patients,” said FDA Commissioner Scott Gottlieb, M.D. “By failing to follow the safety requirements that Aegerion had agreed to, the company put patients’ lives at risk and didn’t honor the safety commitments they made as a condition of gaining approval for their drug. This is unacceptable. We will continue to pursue those who skirt the law, and flout patient safety and other post-market commitments, using all of the enforcement tools available to us. Post-market safety requirements are a key element of the FDA’s public health protections and we will ensure that they are fulfilled.”
As alleged in court documents filed by the U.S. Department of Justice today, rather than following the REMS requirement to distribute Juxtapid only for the narrow indication for which it was approved, Aegerion instead sought to render the diagnosis of homozygous familial hypercholesterolemia (HoFH), a rare disorder that that causes high cholesterol levels and early cardiovascular disease, as vague and indefinite as possible in order to extend the product use to additional patient populations. As part of the required REMS, Aegerion failed to give health care providers complete and accurate information about HoFH and how to properly diagnose it. Aegerion also filed a misleading REMS assessment report to the FDA in which the company failed to disclose that it was distributing Juxtapid using a definition of HoFH that was inconsistent with Aegerion’s pre-approval filings with the FDA and that did not correspond to any peer-reviewed clinical standard for diagnosing HoFH. As such, Aegerion failed to comply with the required elements under the REMS to assure safe use of Juxtapid, in violation of the FD&C Act. In addition, Aegerion management and sales personnel also distributed Juxtapid not only for the treatment of HoFH, but also as a treatment for high cholesterol generally, without adequate directions for such use.
Once entered by the court, the plea and consent decree will be part of a global resolution of multiple government investigations into Aegerion’s conduct with respect to the marketing and distribution of Juxtapid. This resolution was the result of a coordinated effort by the U.S. Department of Justice and several government agencies, including the FDA.
Juxtapid, approved in December 2012 as an adjunct therapy to treat HoFH, is subject to a REMS to ensure that its benefits outweigh its risks. The Juxtapid REMS requires Aegerion to, among other things, (1) educate prescribers about the risks of hepatotoxicity (liver toxicity) associated with the use of Juxtapid and the need to monitor patients who are treated with Juxtapid; and (2) ensure that Juxtapid is prescribed and dispensed only to those patients with a clinical or laboratory diagnosis consistent with HoFH.
EPA Extends Enforcement Discretion for Fuel Storage and Distribution Facilities in Florida
PRESS RELEASE ISSUED 9/ 22/ 17 (link source)
ATLANTA – (September 22, 2017) The U.S. Environmental Protection Agency (EPA) today announced that it will extend enforcement discretion for petroleum distribution facilities, gasoline storage facilities and bulk fuel terminals in Florida that have been impacted or damaged by Hurricane Irma.
EPA issued three additional “no action assurance” letters that are effective immediately and at the request of the State of Florida:
A larger number of tanker trucks is needed to deliver fuel to some areas of Florida due to damaged infrastructure and flooding. EPA will not pursue enforcement actions against tanker trucks for certain provisions of the Clean Air Act and parallel Florida regulations that relate to tank tightness and registration for tanker trucks. This no action assurance will terminate on September 29 and is an extension of a no action assurance issued by EPA on September 15, 2017.
Due to infrastructure damage, Florida refineries are unable to operate at full capacity, which is causing gasoline shortages. EPA will not pursue enforcement actions that relate to violations of provisions of the Clean Air Act for emissions of certain air pollutants from gasoline storage tanks during events known as “roof landings.” This no action assurance will terminate on September 29 and is an extension of a no action assurance issued by EPA on September 15, 2017.
Due to operational issues at bulk fuel terminals as a result of Hurricane Irma, some facilities are not equipped with devices to capture or recover certain types of air pollutants. EPA will not pursue enforcement actions that relate to violations of provisions of the Clean Air Act that require the operation of these devices at bulk fuel terminals. This no action assurance will terminate on September 29, 2017, and is an extension of a no action assurance issued by EPA on September 15, 2017.
Under EPA’s no action assurance letters, the facilities must continue to exercise good air pollution control practices and comply with all other federal, state and local environmental laws.
EPA policy allows the Agency to issue no action assurances in cases where it is necessary to avoid extreme risks to public health and safety and where no other mechanism can adequately address the matter. EPA believes that the exercise of enforcement discretion in these circumstances is in the public interest and will help address the emergency circumstances in Florida.
EPA Honors Restoration Work at Eagle Rock Lake in Questa, NM
PRESS RELEASE ISSUED 9/ 22/ 17 (links source)
DALLAS – (Sept. 22, 2017) The U.S. Environmental Protection Agency (EPA) recognized several groups for excellence and innovation in site restoration in Questa, N.M. EPA presented the Greenovations Award to Chevron Environmental Management Company, the US Forest Service, New Mexico Department of Game and Fish, the Village of Questa, and Chevron's project contractors Arcadis and ENTACT, for redeveloping Eagle Rock Lake at the Questa Mine Superfund site.
The groups were recognized for success in restoring the lake as an asset to the Questa community. Officials from EPA, the Village of Questa, the New Mexico Environment Department, Sen. Tom Udall's office, and the New Mexico Energy, Minerals and Natural Resources Department were on hand for a presentation ceremony on Friday, September 22, at Eagle Rock Lake. As part of the ongoing cleanup of the former molybdenum mine, the honorees partnered to restore the formerly contaminated lake, which now provides fishing and other recreation opportunities for the Questa community.
The Greenovations Award can be given to a responsible party, developer, site owner, nonprofit, local government or community member who has demonstrated excellence in working cooperatively with EPA to support safe and responsible cleanup and reuse, especially those that promote innovative and sustainable reuse outcomes.
The Chevron Questa Mine, previously known as the Molycorp Mine, operated intermittently from 1920 until 2014, when Chevron Mining Inc. permanently closed the mine. Open-pit mining took place from 1965 to 1983. Mining operations and waste disposal contaminated soil, sediment, groundwater, and surface water (including Eagle Rock Lake).
WORLD AND NATIONAL NEWS BRIEFS
From Reuters:
North Korea says rockets to U.S. 'inevitable' as U.S. bombers fly off North Korean coast
UNITED NATIONS/WASHINGTON (Reuters) - North Korea said on Saturday targeting the U.S. mainland with its rockets was inevitable after “Mr. Evil President” Donald Trump called Pyongyang’s leader “rocket man”, further escalating rhetoric over the North’s nuclear weapons and missile programs.
Trump cranks up North Korea threats as Pyongyang holds anti-U.S. rally
SEOUL/UNITED NATIONS (Reuters) - U.S. President Donald Trump dialed up the rhetoric against North Korea again at the weekend, warning the country’s foreign minister that he and leader Kim Jong Un “won’t be around much longer”, as Pyongyang staged a major anti-U.S. rally.
Germans warned against apathy as Merkel heads for fourth term
BERLIN (Reuters) - Turnout slipped slightly in Germany’s election despite politicians warning that apathy could boost the far-right, expected to return to parliament after a half century’s absence, overshadowing Chancellor Angela Merkel’s expected victory.
NATIONAL
Trump urges fans to consider NFL boycott over player anthem protests
SOMERSET, N.J. (Reuters) - U.S. President Donald Trump on Sunday stepped up his criticism of National Football League players who protest during the pre-game national anthem, calling on fans to consider boycotting the NFL if teams do not discipline them.
Trump pressures U.S. senators to back Republican healthcare bill
WASHINGTON (Reuters) - U.S. President Donald Trump on Saturday blasted Senator John McCain for dealing a possibly fatal blow to the latest Republican attempt to dismantle Obamacare.
Protests could derail St. Louis' bid for second Amazon hub: sources
ST. LOUIS (Reuters) - Protests in St. Louis over the acquittal of a white former policeman who killed a black man could impede the city’s bid to attract Amazon.com’s second headquarters, academics and business executives said.
President Donald J. Trump’s Weekly Address
Posted on the White House webpage 9/ 22/ 17 (source link)
Excerpt: My fellow Americans,
The American Family has always been the heart of our great nation. In homes across this country, families teach their children to work hard, to love each other, and to make the most of their talents in pursuit of their dreams.
Yet for too long, American families have been hurt by Washington’s policies that put the interests of other countries before the interests of our country.
That is why, in my Administration, we are pursuing tax cuts and reform that create jobs in America, for American workers – not foreign workers, but American workers.( See full text on the link source link)
From the WP: Dozens of players kneel, coaches link arms in solidarity as Trump asks NFL teams to ‘fire or suspend’ protesting players---WP
Quote: “If NFL fans refuse to go to games until players stop disrespecting our Flag & Country, you will see change take place fast,” Trump wrote. “Fire or suspend!”
Editorial Comment: Apparently, Athletes, and Entertainers alike seem to forget one thing, they seem to forget who really pays their paychecks, the fans! The fans of both the sport, and entertainment industry should be belly aching when fans choose to exercise their constitutional right to protest them for their disrespect for old glory, by boycotting movies, or ball games.
The week's bible lesson
Gospel Way: Why So Many Denominations?
In the religious world today there are many different religious groups. Each has its own peculiar name, organization, doctrine, form of worship, and plan of salvation. Why are there so many religious groups? Nearly all Bible students agree that in the New Testament there was only one church belonging to Jesus. Denominations did not exist. But today there are hundreds of churches all claiming to believe in God and most claiming to follow Jesus. Where did they all come from?
https://www.gospelway.com/topics/church/denomination-origins.php
