Monday, February 28, 2011

Support NEHA in Opposing Budget Cuts to Environmental Health - 2/28/2011

Please Support NEHA’s Strong Opposition to Proposed Budget Cuts that Impact Environmental Health

The National Environmental Health Association (NEHA) is deeply concerned about the Continuing Resolution and FY 2011 budget recommendations that have been proposed for the Centers for Disease Control and Prevention (CDC) and the U.S. Environmental Protection Agency (EPA). Additionally, NEHA is strongly opposing the FY 2012 CDC budget recommendations as presented in both the president’s budget and the majority report released by the House Appropriations Committee. The scope and magnitude of the proposed cuts will adversely affect the ability of environmental health programs at the federal, state, and local levels to provide basic and essential services. In addition, much of the proposed cutting threatens to reverse the gains that have been made to safeguard our environment and protect human health. Many proposed cuts also take aim at the very programs where future environmental health needs are likely to be the greatest.

NEHA joins a growing number of environmental, scientific, and public health professionals in objecting to this significant cutback on the programs needed to protect the health and safety of the American people. In response, NEHA has sent three letters to 48 Senators and Congressional Representatives who serve on the appropriation subcommittees and have jurisdiction over CDC and EPA; two were sent in opposition to the CDC and EPA proposed budget cuts, respectively, and one was sent in strong support of the funding recommendations contained in the President’s budget for both FY 2011 and FY 2012 concerning the Food and Drug Administration (FDA). (The president has recommended expanded funding for food safety work within the FDA.)

We urge you at this time to enhance the strength of the positions taken by NEHA by contributing your voice to this policy debate. In other words, we would appreciate it if you would also contact your Congressional delegation to express the same kinds of concerns that NEHA has. (To view the three positions taken by NEHA, please click here. )

You can write to your U.S. Senator and Representative today by visiting www.house.gov and entering your zip code, and www.senate.gov and selecting your state. Contact information and guidance on how to communicate with these individuals can be found on their websites. Each of these websites also contains information about the membership of the relevant sub-committees of the appropriation committee in the senate and house.* If one of your Representatives or Senators sits on one of these appropriations subcommittees, it becomes even more important that you contact them as they are directly involved in these crucial budget decisions.

Additionally, telephone calls can be a powerful tool in communicating with members of Congress. To contact the U.S. Capitol directly, call 202-224-3121.

Please join NEHA in standing up for our profession!
• *For EPA: House and Senate- Appropriation Subcommittee on Interior, Environment and related agencies
• *For FDA AND CDC: House and Senate- Appropriation Subcommittee on Health, Labor Education

New Tools in Fighting Norovirus - 2/28/2011

FDA permits marketing of first test for most common cause of gastroenteritis outbreaks
Test can aid in identifying and containing norovirus outbreaks

The U.S. Food and Drug Administration allowed marketing of the first test for the preliminary identification of norovirus.

The Ridascreen Norovirus 3rd Generation EIA assay is for use when a number of people have simultaneously contracted gastroenteritis and there is a clear avenue for virus transmission, such as a shared location or food.

Norovirus is a leading cause of food-borne disease outbreaks in the United States.

Acute gastroenteritis is an inflammation of the stomach and intestine that can cause diarrhea, vomiting and stomach pain. Norovirus contamination usually occurs in settings where there is close group contact, such as cruise ships, hospitals, long-term care facilities, and schools or child-care centers. It is a highly contagious virus that spreads rapidly through direct person-to-person contact, contaminated food or water, and by touching contaminated surfaces.

“This test provides an avenue for early identification of norovirus,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Early intervention can halt the spread of an outbreak.”

The test is not sensitive enough for use when only a single person has symptoms and should not be used for diagnosing individual patients.

The manufacturer demonstrated the performance of the Ridascreen test by comparing results of it to the results of a norovirus reference standard for 609 fecal samples. When the fecal samples were tested with Ridascreen, overall results on average were less sensitive than those of standard reference tests, detecting norovirus across samples about 2/3 of the time it was present.

The FDA reviewed data for Ridascreen via the de novo pathway, an alternative path to market for devices that are lower risk and may not require premarket approval (PMA), but are of a new type, and therefore may not be able to be cleared in a '510(k)' premarket notification.

In March, the U.S. Centers for Disease Control and Prevention will be updating management and disease prevention guidelines for norovirus outbreaks. These guidelines will likely reflect substantial advances made in norovirus epidemiology, immunology, diagnostic methods and infection control.

Ridascreen is made by R-Biopharm AG, located in Darmstadt, Germany.

For more information:


FDA: Medical Devices1
CDC: Norovirus2
HHS: Norovirus3

Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

Tuesday, February 15, 2011

Excerpt from President Obama's 2012 Budget -$2.7B for FDA - 2/15/2011

Bolsters the Safety of the Nation’s Food
and Medicines.
The Budget includes $2.7 billion
in budget authority and $4.4 billion in total
program resources for the Food and Drug Administration
(FDA). The Budget enables FDA to
further the core principles recommended by the
President’s Food Safety Working Group and implement
key elements of the Food Safety Modernization
Act. The Administration will work with
the Congress to enact additional food safety fees
to support the full implementation of the FDA
Food Safety Modernization Act and the Budget
reflects the collection of these fees in 2013 and beyond.
In 2012, FDA will advance efforts to implement
the ACA provisions to establish a pathway
to approve biosimilar products and to improve
nutrition labeling. To better protect health in response
to natural or intentional threats, the Administration also invests in FDA’s efforts to advance regulatory science and support the review
of new medical countermeasures for chemical, radiological,
biomedical, and nuclear threats.

Monday, February 14, 2011

“If You See Something, Say Something™”

To improve suspicious activity awareness and reporting within the Food and Agriculture Sector, this one-page document was developed by Department of Homeland Security and other federal agencies to highlight indicators of suspicious activities and recommended protective measures by food service and retail food establishments. This document is intended to be posted in work areas to make employees aware of what they should be looking for each day and what actions they should take if they observe something suspicious.

http://www.neha.org/pdf/food_safety/Food_and_Agriculture_See_Something.pdf

Thursday, February 10, 2011

New FDA Materials on Sanitation Concerns with Commercial Deli Slicers - 2/09/2011

As part of an initiative to improve food safety practices in retail and foodservice establishments, FDA has developed a poster and flyer designed to raise awareness of sanitation concerns with commercial deli slicers commonly used to slice meats, cheeses and produce in food stores, delis, restaurants and other foodservice establishments:

The poster, targeted to operators of food establishments and their front line food employees, is suitable for posting near deli slicers, and explains the importance of proper slicer maintenance and highlights examples of hard-to-clean problem areas on deli slicers.
The flyer, targeted to food safety professionals, offers tips to ensure deli slicers are being properly cleaned and maintained and when slicers should be removed from service until repaired or replaced
If deli slicers are not properly cleaned and sanitized on a regular basis, food soils and disease-causing microorganisms can accumulate on slicer surfaces and result in food contamination. These machines have a long life in retail and foodservice establishments, and over time they may become difficult or impossible to properly clean and sanitize. Routine professional maintenance of all deli slicers is critical to preventing these machines from becoming a significant food safety hazard.

Outbreaks of foodborne illness resulting in serious illnesses and hospitalizations have been linked to food that has become contaminated during contact with deli slicers. FDA continues to work closely with state and local governments and operators of restaurants, grocery stores and other food establishments to prevent illness from contaminated food. FDA is working with stakeholders to develop enhanced minimum standards for the design and construction of new deli slicers and to ensure that proper cleaning and maintenance instructions are provided with each machine.

FDA encourages consumers to ask store and restaurant management about the procedures they follow to ensure their deli slicers are properly cleaned and maintained.

The new poster and flyer are available in both English and Spanish at no charge and can be ordered at: http://www.fda.gov/downloads/Food/ResourcesForYou/UCM222258.pdf1
For orders greater than 500, contact Shirley Turpin at shirley.turpin@fda.hhs.gov.
The documents can also be downloaded from the web at: http://www.fda.gov/Food/FoodSafety/RetailFoodProtection/IndustryandRegulatory
AssistanceandTrainingResources/ucm240554.htm2