Showing posts with label PUBLIC HEALTH. Show all posts
Showing posts with label PUBLIC HEALTH. Show all posts

Tuesday, October 22, 2013

FDA'S APPROACH TO HARVESTING SAFE CLAMS

FROM:  U.S. FOOD AND DRUG ADMINISTRATION 
Novel Program Restarts Clam Harvest

One of the largest clam beds in the world closed in 1990 because people could get sick and even die from eating clams contaminated with a deadly marine toxin.

This year, however, a large portion of the area called Georges Bank, 62 miles off the coast of New England, reopened after the Food and Drug Administration (FDA) developed a new approach toward this risk to public health.

One major element involves having an FDA scientist train fishermen to perform sophisticated scientific tests on the clams while at sea, sometimes under extreme conditions.

"This program has almost doubled the number of quahog clams available on the market, and increases the availability of surf clams by about 40%," says David Wallace, a consultant for the seafood industry. "If it hadn't been for the FDA, these multi-billion dollar resources would be going to waste. It's good for fishermen, for consumers and for the economy." (The meat of quahog clams is tougher than surf clams and is often used in chowder, while surf clams often show up in raw bars.)

This is the story of how fishermen, industry representatives, state officials and multiple branches of the federal government worked together to create a novel plan that is allowing clams to be harvested from a major portion of Georges Bank—a vast submerged sandbank that extends from Massachusetts to Nova Scotia.

A Once Risky Catch
The story begins in the late 1980s, when harvest areas were temporarily closed due to the reports of toxins in surf clams from Georges Bank. After a brief reopening in early 1990, harvest areas were closed again when fishermen clamming on Georges Bank ate contaminated mussels caught while fishing for clams and became extremely ill.

The diagnosis: paralytic shellfish poisoning, caused by a toxin produced by Alexandrium algae. The toxic algae has been cited for centuries and is sometimes referred to as "red tide," even though not all red tides are toxic, and not all toxic blooms are red.

The toxin concentrates in the flesh of mollusks, including clams and mussels, and doesn't seem to hurt them. But in high enough concentrations, this potent toxin can temporarily paralyze humans. If this happens, the paralyzed person could die of asphyxiation if he or she is not put on life support until the toxins are flushed from the body. Cooking the mollusks does not neutralize the toxins.

FDA officials, who are responsible for the safety of seafood caught in federal waters, could not put scientists on board every clam fishing vessel far out at sea to test the clams for the toxin. It didn't make economic sense for fishermen to spend the time and money harvesting clams if they might arrive at the harbor, discover they had a boat filled with toxic clams, and then be responsible for safely disposing of them.

The 1990 closure of Georges Bank was a huge blow to the clam industry. The situation became even more dire in 2005, when a massive algal bloom near the New England shores temporarily closed another 15,000 square miles of ocean to clamming.

The clam industry, finding itself in peril, decided to invest the time and money required to find a solution, and began working with state and federal officials. After years of research on a harvesting procedure that could deliver safe clams at the dock, followed by an intense, years-long research and a pilot program, a huge portion of Georges Bank reopened in 2013 to clam fishermen who agreed to work under a new FDA procedure. This includes having fishermen take the FDA-provided training needed to conduct very precise scientific tests of clam samples while out to sea.

"There was a lot of skepticism. How would the fishermen react to listening to days of lectures from a young government scientist? Could they accurately conduct tests that sometimes even challenge lab scientists?" says FDA marine biotoxin expert Stacey DeGrasse, who has provided the FDA training.

"The project, however, is incredibly successful. The fishermen take great pride in performing the on-board lab tests and provide exact, pristine data," says DeGrasse.

The Tale of a Solution
The apex of the crisis in the clamming industry occurred just as FDA was conducting a research project with Woods Hole Oceanographic Institution. This extensive research project provided a greater understanding of the source of the toxins, movement of the toxins within the marine food web, the role of Alexandrium cyst (seed) beds as sources for future toxic algal blooms, and more.

Continued research efforts in this area focus on identifying effective early warning systems that could be used by state and federal regulators to determine when to open and close fishing areas. The policy side of the project is led by Paul Distefano, a consumer safety office in FDA's Center for Food Safety and Applied Nutrition.

One aspect of the project was aimed at training fishermen to use a field kit to test their product for the presence of dangerous marine toxins.

As one major aspect of the first test procedure, fishermen were first trained how to collect the correct number of representative samples of their catch and to shuck the clams without piercing the flesh. The samples were then mixed together in a kind of upscale blender to get an even, well-mixed consistency. Using household chemicals in the kit, the fishermen then learned to separate out any toxins that might be present. Finally, using something akin to a drugstore pregnancy test, the fishermen would test whether the potency of any toxin was at a dangerous level.

Tests of the field kit began at sea in 2007, but the kits provided too many results that were false positives. A better field kit was needed, and one used by lab scientists was identified. "I had doubts about how this was going to go," says DeGrasse. "The new kit was definitely more complicated, but I figured it was worth a try."

She worked with Abraxis, a test kit manufacturer, to make some adjustments. For one thing, the kit needed to be recalibrated to better target the toxins of concern. It also required modifications to make it usable at sea.

In 2009, after FDA had collected sufficient data, the new Abraxis kits were approved by the Interstate Shellfish Sanitation Conference (ISSC), a consortium of government officials, industry representatives and academics devoted to seafood safety. For a pilot program, the National Oceanic and Atmospheric Administration (NOAA) agreed to allow one fishing vessel to dredge for clams in the closed waters of Georges Bank for a year, a maximum of one time per week.

DeGrasse trained the fishermen for one day on land, then took the test kit out to sea and did further training on two-to-three-day clamming cruises. Once they were trained, the fishermen performed the onboard testing and sent portions of their samples to FDA for further scientific analyses. Later, when the vessel docked, state officials in Massachusetts performed a bioassay—an even more robust test that measures the overall potency of any toxins present.

That year, on just 37 fishing trips, that single vessel hauled in $2.7 million worth of surf clams that passed testing for toxins.

"The exciting part came when we put all the data together, and in 2011 the ISSC adopted the on-board screening protocol," says DeGrasse.

This year, NOAA reopened a large portion of Georges Bank to any fishermen who follow the established protocol, which includes on-board testing at sea by fishermen and back-up tests on land by government scientists.

"This has allowed the catch of literally billions of dollars worth of clams that otherwise would have died of old age," said Wallace. "It's a perfect example of how states, federal agencies and industry can work together to find solutions."

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

Sept 17, 2013

Sunday, December 9, 2012

HUMAN ACTIVITY IS DRIVING SPREAD OF DISEASES


American robins play a key role in the spread of West Nile virus.  Credit:  NSF.

FROM: NATIONAL SCIENCE FOUNDATION

Emerging Vector-Borne Diseases Create New Public Health Challenge
Land-use change, globalization of trade and travel, and social upheaval drive emergence of diseases
Human activities are advancing the spread of vector-borne, zoonotic diseases such as West Nile virus, Lyme disease and dengue fever, report scientists publishing a series of papers today in the journal The Lancet.

Vector-borne zoonotic diseases result from disease-causing agents or pathogens that naturally infect wildlife, and are transmitted to humans by carriers such as mosquitoes and ticks. In short, they're diseases transmitted between animals and humans.

Widespread land-use change, globalization of trade and travel, and social upheaval are driving the emergence of zoonotic diseases around the world, said biologist Marm Kilpatrick, who studies the ecology of infectious diseases at the University of California, Santa Cruz.

Kilpatrick co-authored one of several papers in The Lancet, along with Sarah Randolph of the University of Oxford. The Lancet papers are part of a special series in the journal focused on emerging zoonotic diseases.

"Increasing human population, and the urbanization and agricultural intensification of landscapes, put strong selective pressure on vector-borne pathogens to infect humans--and to be transmitted by vectors and hosts that live around humans," Kilpatrick said.

"Humans are altering the environment and moving ourselves and other organisms around the globe at an ever-increasing pace," said Sam Scheiner, a program director for the Ecology and Evolution of Infectious Diseases (EEID) program at the National Science Foundation. "Our fast-track has led to a growing disease threat."

EEID is a joint effort with NSF and the National Institutes of Health. At NSF, the Directorate for Biological Sciences and Directorate for Geosciences fund the program.

EEID funded much of the research discussed in The Lancet papers. "These papers show how and why zoonotic diseases are emerging, and what we need to know to ease the disease burden," said Scheiner.

The papers "offer a bridge between ecologists and clinicians whose combined efforts are needed to address the ongoing challenges of emerging zoonotic diseases," said Kilpatrick.

Added scientist Peter Daszak, president of the EcoHealth Alliance in New York City and author of a paper in the series, "Pandemic zoonoses such as SARS, Ebola and HIV/AIDS are devastating when they emerge. What this series shows is that we have new ways of predicting their origins, of discovering them even before they reach our population--truly a brave new world for pandemic prevention."

There are roughly two types of emerging infectious diseases: introduced and locally emerging.

Introduced diseases arise from the spread of a pathogen to a new location, as when West Nile virus arrived in New York in 1999 and subsequently spread across North America.

Locally emerging diseases increase in importance in areas where they are endemic, as with Lyme disease in the United States during the past three decades.

These two types of emerging diseases can differ markedly with respect to infection dynamics or the number of cases over time, Kilpatrick said.

"Introduced diseases often cause a big spike in infections, and then decrease substantially. Locally emerging diseases often show a steady, sustained rise."

The movement of pathogens by global trade and travel results in the emergence of diseases in new regions.

Once established, introduced pathogens often evolve to take advantage of their new environments, including new hosts and vectors.

With much of the landscape shaped by human activities, pathogens may thrive by infecting hosts and vectors that do well in man-made environments.

Emergence of endemic vector-borne diseases can result from changes in land use, such as movement of people into new habitats, or environmental changes that affect wild animals that serve as natural hosts--and the insect vectors that spread the disease to humans.

Although vector-borne diseases are sensitive to climate, climate change does not appear to be a major driving force behind emerging diseases.

"So far, climate change has been a relatively minor player compared to land use and socioeconomic factors in the emergence of vector-borne disease," Kilpatrick said.

Social and economic changes, ranging from economic downturns to displacement of populations by armed conflict, frequently precipitate disease outbreaks through their effects on public health systems, sanitation systems, behavioral patterns and uses of natural environmental resources.

The incidence of any vector-borne disease involves a complex interplay of multiple factors affecting animal hosts, vectors and people.

Kilpatrick and Randolph emphasize that control of these diseases requires combined efforts by clinicians and public health officials to treat patients; promote behavior likely to minimize the risk of infection; and advise on efforts to reverse the ecological drivers of transmission through vector control, urban planning and ecological restoration.

The Lancet papers are published ahead of a special 20th anniversary symposium to be held on Dec. 11 and 12, 2012, in Washington, D.C.

The symposium is hosted by the National Academies' Institute of Medicine's Forum on Microbial Threats. The symposium will take a retrospective look at the Institute of Medicine's 1992 report on Emerging Infections and its 2003 report on Microbial Threats to Health, as well as its creation of the forum in 1996.


Sunday, May 20, 2012

G8 LEADER'S STATEMENT ON THE GLOBAL ECONOMY


Credit:  Wikimedia.  
FROM:  U.S. STATE DEPARTMENT
Statement by G8 Leaders on the Global Economy
May 19, 2012
Our imperative is to promote growth and jobs.
The global economic recovery shows signs of promise, but significant headwinds persist.
Against this background, we commit to take all necessary steps to strengthen and reinvigorate our economies and combat financial stresses, recognizing that the right measures are not the same for each of us.

We welcome the ongoing discussion in Europe on how to generate growth, while maintaining a firm commitment to implement fiscal consolidation to be assessed on a structural basis. We agree on the importance of a strong and cohesive Eurozone for global stability and recovery, and we affirm our interest in Greece remaining in the Eurozone while respecting its commitments. We all have an interest in the success of specific measures to strengthen the resilience of the Eurozone and growth in Europe. We support Euro Area Leaders’ resolve to address the strains in the Eurozone in a credible and timely manner and in a manner that fosters confidence, stability and growth.

We agree that all of our governments need to take actions to boost confidence and nurture recovery including reforms to raise productivity, growth and demand within a sustainable, credible and non-inflationary macroeconomic framework. We commit to fiscal responsibility and, in this context, we support sound and sustainable fiscal consolidation policies that take into account countries’ evolving economic conditions and underpin confidence and economic recovery.

To raise productivity and growth potential in our economies, we support structural reforms, and investments in education and in modern infrastructure, as appropriate. Investment initiatives can be financed using a range of mechanisms, including leveraging the private sector. Sound financial measures, to which we are committed, should build stronger systems over time while not choking off near-term credit growth. We commit to promote investment to underpin demand, including support for small businesses and public-private partnerships.

Robust international trade, investment and market integration are key drivers of strong sustainable and balanced growth. We underscore the importance of open markets and a fair, strong, rules-based trading system. We will honor our commitment to refrain from protectionist measures, protect investments and pursue bilateral, plurilateral, and multilateral efforts, consistent with and supportive of the WTO framework, to reduce barriers to trade and investment and maintain open markets. We call on the broader international community to do likewise. Recognizing that unnecessary differences and overly burdensome regulatory standards serve as significant barriers to trade, we support efforts towards regulatory coherence and better alignment of standards to further promote trade and growth.

Given the importance of intellectual property rights (IPR) to stimulating job and economic growth, we affirm the significance of high standards for IPR protection and enforcement, including through international legal instruments and mutual assistance agreements, as well as through government procurement processes, private-sector voluntary codes of best practices, and enhanced customs cooperation, while promoting the free flow of information. To protect public health and consumer safety, we also commit to exchange information on rogue internet pharmacy sites in accordance with national law and share best practices on combating counterfeit medical products.

Wednesday, May 2, 2012

IMPLEMENTATION OF 2008 OZONE STANDARDS


FROM:  U.S. ENVIRONMENTAL PROTECTION AGENCY
EPA Takes Next Step to Implement 2008 Ozone Standards
Most areas that need to take steps to reduce ozone pollution are close to meeting the standards; only three new areas have been added
 WASHINGTON – Working closely with states and tribes, the U.S. Environmental Protection Agency (EPA) is identifying areas that meet or do not meet the 2008 air quality standards for ground-level ozone, known as smog. The agency’s approach to implementing these standards will improve air quality, protect public health, increase certainty for states and tribes, maximize flexibilities and minimize the burden on state, tribal and local governments. Breathing air containing high levels of smog can reduce lung function and increase respiratory symptoms, aggravating asthma or other respiratory conditions. Ozone exposure may also contribute to premature death, especially in people with heart and lung disease.

In 2008, EPA set new smog standards at 75 parts per billion. Working with states and tribes and following an open public process that included a 45-day public comment period, EPA has determined that 45 areas across the country, including two separate areas of Indian country, are not meeting the 2008 standards based on the most recent certified air quality data. Almost all of these areas already have programs in place to improve air quality because they did not meet the 1997 smog standards. Only three areas will be identified for the first time as not meeting smog standards. Reflecting ongoing improvements in air quality, EPA is identifying fewer areas that do not meet the 2008 standards than the agency identified as not meeting the 1997 standards.

Reducing smog and improving air quality is a shared responsibility of federal, state, local and tribal governments. National clean air programs such as EPA’s standards to reduce power plant emissions that cross state lines, clean vehicle and fuel standards, and more locally focused state, tribal air quality programs are already contributing to air quality improvements. These actions will help areas meet the standards and protect public health. In addition, EPA expects that most areas would be able to meet the 2008 standards as a result of recent and pending rules.

The Clean Air Act requires EPA to review and, if necessary, revise air quality standards every five years to ensure that they protect public health with an adequate margin of safety. Following a change in standards, EPA works with states and tribes as appropriate to identify areas that do not meet the standards and establish plans to improve air quality. EPA continues to work to review the science needed to inform the next five-year review of the smog standards and currently expects to propose action in 2013.

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