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New Food Safety Act Enforcement Tools
by Caroline Smith DeWaal | Jan 31, 2011
Editor's note: This is the
second in a series of articles from Center for Science in the Public
Interest Food Safety Director Caroline Smith DeWaal on the implementation
of the FDA Food Safety Modernization Act. In the second installment,
DeWaal looks at several new enforcement tools - suspension of registration
and records access - that emerged from lessons learned from the Bioterrorism
Act of 2002.
The effort to modernize the
Food and Drug Administration's (FDA) food safety program began in the
late 1990s, following several very large outbreaks linked to raw oysters
and imported berries. One outbreak involved berries tainted with Hepatitis
A that were processed into a dessert served by the school lunch program,
and underscored for consumers our vulnerability. That outbreak sickened
over 250 consumers in five states, many of whom were school children.
The first bill titled, "The
Consumer Food Safety Act of 1998," was filed in April of that year
by Representative Frank Pallone, with 29 cosponsors, including both
Representative Henry Waxman and Representative Rosa DeLauro. While it
was a relatively simple bill compared to what finally passed Congress
late last year, the legislation contained many of its essential elements,
including both registration and process controls.
In 2001, when Congress was
grappling with the aftermath of the attack on the World Trade Center,
concerns were raised by then-Secretary of Health and Human Services
Tommy Thompson that our food supply could become a target. In fact,
Thompson told Congress that he was most concerned about food as a target
because inspections were not adequate. In response, Congress included
a number of food provisions in the Bioterrorism Response Act of 2002,
along with $100 million for improvements in inspection and counterterrorism
programs. The agency was given authority to register domestic and foreign
facilities, detain suspect food items, require prior notice on all imported
food shipments, and also required "one up/one down" traceability.
The FDA Food Safety Modernization
Act significantly improves the registration provision and adds records
access requirements that will be critical to preventing future outbreaks.
While registration of food facilities doesn't sound like a program that
will give teeth to the new FDA Foods program, in fact, when coupled
with suspension, it gives FDA a powerful new enforcement tool. To understand
why, let's back up and look at the history of the issue.
Prior to 2002, FDA inspectors
went into the field not knowing who exactly they should be inspecting.
An Inspector General report once noted that FDA inspectors would refer
to the Yellow Pages of the local phone book to find food plants in an
area. The registration provision was adopted by Congress in order to
give the agency a comprehensive list, with names, addresses and contact
information for the food plants under its jurisdiction. While the 2002
Bioterrorism Act provided a first step for registration, its implementation
by FDA was lackluster, and the database of food plants soon became out-of-date.
The initial registration
provision under the Bioterrorism Act required registrants to "notify
the Secretary in a timely manner of changes to [registration] information,"
and required FDA to compile and maintain an up-to-date list of registered
facilities. The new Act is more specific and requires food facilities
to re-register between October and December of each even numbered year
beginning in 2012.
Authority to suspend the
registration of a food facility is perhaps one of the most important
enforcement tools the new law grants FDA. It allows the agency to effectively
shut down a food facility that is associated with an outbreak of serious
foodborne illness. A facility under suspension cannot import, export,
or ship food until the business takes corrective action. This provision
becomes effective no later than 180 days after enactment of the law
or earlier, if regulations are issued by FDA. The new authority artfully
shifts the legal burden between industry and the agency to create incentives
for businesses to comply with food safety requirements, while giving
the agency real teeth to address non-compliance. To keep FDA from overreaching,
the authority to suspend a facility resides with the Commissioner, and
businesses are provided an opportunity to contest the suspension within
two days of its issuance.
The Commissioner can reinstate the registration when the evidence shows
that adequate grounds do not exist for its continuation. Thus, a facility
can submit a corrective action plan for FDA's approval, and once approved,
it can begin shipping product again. Suspension authority will be an
effective enforcement tool if properly implemented. This provision gives
FDA a significant new tool to go along with its broad responsibility
to protect the public from unsafe food.
Another treasure in the Act
is the records access provisions. To gain access to corporate records
under the 2002 Bioterrorism Act, FDA needed evidence of adulteration
as well as a serious risk to health or life. It also required that record
requests be in writing. This delayed access to critical corporate records
during outbreak investigations like one involving peanut butter and
led the agency to ask Congress to relax the adulteration requirement.
Additionally, the Bioterrorism Act only allowed FDA to access records
for the food under investigation, preventing inspectors from following
leads to other food lines within the same facility.
The new law gives FDA clear
authority to access a facility's written food safety plan, together
with monitoring and test results, during its regular inspections of
the food plant. These records must be made available to "a duly
authorized representative of the Secretary upon oral or written request."
This will greatly aid the FDA in improving the effectiveness of its
inspections. No longer will the agency be doing a simple inspection,
reflecting only its findings during the time inspectors are in the plant.
Through a random review of records for different days or even weeks,
FDA can transition to conducting inspections that reflect activities
in the plant over a longer time frame. And during an investigation of
an outbreak, the FDA Food Safety Modernization Act provides clear authority
to expand an inquiry to other food lines within a facility, provided
there is a reasonable belief the food processed on them is affected
in the same way as the food under investigation.
The FDA never realized the
full benefit of new authorities to oversee and enforce food safety laws
it gained in the 2002 Bioterrorism Act. The Food Safety Modernization
Act takes lessons learned from a decade of outbreak investigations to
give the agency tools for protecting public health. The agency will
need to move forward rapidly on regulations to put muscle in and reap
the full value of these tools.
bacteria causes difficult-to-treat heart infections
Published: Thursday, Jan 27, 2011, 15:21 IST
Place: Washington, DC | Agency: ANI
Scientists have found that
particular strains of a food-borne bacteria are able to invade the heart,
leading to serious and difficult-to-treat heart infections.The bacteria
Listeria monocytogenes is commonly found in soft cheeses and chilled
ready-to-eat products, according to researchers at the University of
Illinois at Chicago College of Medicine.
For healthy individuals,
listeria infections are usually mild, but for susceptible individuals
and the elderly, infection can result in serious illness, usually associated
with the central nervous system, the placenta and the developing fetus.About
10 percent of serious listeria infections involve a cardiac infection,
according to Nancy Freitag, principle investigator on the study. These
infections are difficult to treat, with more than one-third proving
fatal, but have not been widely studied and are poorly understood.Freitag
and her colleagues obtained a strain of listeria that had been isolated
from a patient with endocarditis, or infection of the heart.They found
that when they infected mice with either the cardiac isolate or a lab
strain, they found 10 times as much bacteria in the hearts of mice infected
with the cardiac strain. Further, the researchers found that while the
lab-strain-infected group often had no heart infection at all, 90% of
the mice infected with the cardiac strain had heart infections. Freitag's
team used molecular genetics and cardiac cell cultures to explore what
was different about these two strains.The results suggest that these
cardiac-associated strains display modified proteins on their surface
that enable the bacteria to more easily enter cardiac cells, targeting
the heart and leading to bacterial infection.The study appeared online
in the Journal of Medical Microbiology.
Merrick product - salmonella risk for people and pets
Source : http://www.examiner.com/
By Valerie Heimerich, (31, Jan, 2011)
Merrick Pet Care has announced
that it is recalling one of their pet food items because of possible
salmonella contamination. Merrick products are carried in over 40 Sacramento
area retail stores.
On Friday a U.S Food and Drug Administration press release identified
the recalled product as Jr. Texas Taffy, a dog treat.
Adults or children may be at risk if they have touched a contaminated
pet product or any surface on which the dog treat may have been placed.
The impact of salmonella on pets and people can include vomiting, abdominal
pain and bloody diarrhea.
But the list of illnesses for humans exposed to salmonella is much longer
and more serious. These include but are not limited to the inflammation
of heart chambers and valves, arterial infections and eye and urinary
For details on impacted item and lot numbers, click here.
No illnesses have been reported to date. Anyone who has purchased the
Merrick Jr. Texas Taffy is being urged to return the unused portion
for a full refund.
If you found this story informative or enjoyable, click on the "subscribe"
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additional articles by Val Heimerich are published. Ms. Heimerich welcomes
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Get Botulism Warning
Source : http://www.foodsafetynews.com/
By Dan Flynn, (28, Jan, 2011)
Oregon's 121-year old Newman's Fish Markets Inc. received a warning
letter last Dec. 7 from the U.S. Food and Drug Administration (FDA)
over violations at its seafood processing facility in Portland.
It concerns Newman's hot smoked, vacuum-packed, refrigerated salmon;
sturgeon; escolar; tuna and black cod.
FDA said fish processors must have seafood Hazard Analysis and Critical
Control Point (HACCP) plans for hot smoked, vacuum-packed, refrigerated
sturgeon to control the food safety hazard of Clostridium botulinum
and environmental chemical contaminants.
During an inspection last July 29, FDA said it watched Newman's smoke
a batch of fish that included sturgeon. Company managers told the inspector
they would freeze the vacuum packaged products to prevent the formation
of deadly botulism.
Newman's said it was planning to use stickers to urge consumers to keep
the packages frozen and to thaw them under refrigeration right before
use. FDA said Clostridium botulinum is a "reasonability likely
hazard" for vacuum packaged fish, especially those that lack clear
FDA expressed similar concerns about Newman's smoked salmon.
The agency said Newman's must conduct or have conducted for it a hazard
analysis for each kind of fish and fishery product that it produces
to determine whether there are food safety hazards that are reasonably
likely to occur and to have a HACCP plan that, at a minimum, lists the
food safety hazards that are reasonably likely to occur.
The plan must address "any biological, chemical, or physical property
that may cause the food to be unsafe for human consumption."
Newman's HACCP plan for hot smoked black cod does not list the food
safety hazard of Clostridium botulinum at the "Refrigerated Storage"
Newman's Sept. 7 response included a revised HACCP plan for hot smoked,
vacuum-packaged refrigerated escolar and tuna, but for not black cod.
The seafood processors' revised HACCP plan for escolar and tuna does
not identify the hazard of histamine formation. FDA said the company
eliminated "brining" as a control.
"Although the formation of Clostridium botulinum may not be a significant
hazard for this product if it is labeled to be held frozen and thawed
under refrigeration immediately before use, histamine formation is considered
a food safety hazard that is reasonably likely to occur at the "brining"
CCP, the warning letter said.
FDA said Newman's lacked monitoring procedures for minimum salt content,
and ratio of brine to fish. The agency also said Newman's does not list
"the critical control point of thawing for controlling the food
safety hazard of histamine formation. According to your hazard analysis
you are controlling this hazard through refrigeration and icing."
FDA gave Newman's 15 working days to respond to its concerns.
Newman's was founded in Eugene, OR in 1890.
Do not eat Salmonella
Source : http://www.marlerblog.com/case-news/do-not-eat-salmonella-cilantro/
By Bill Marler, (29, Jan, 2011)
Dr. Mark Horton, director
of the California Department of Public Health (CDPH), today warned people
not to eat certain fresh cilantro distributed by Tanimura & Antle,
based in Salinas, because the cilantro may be contaminated with Salmonella.
To date, no illnesses have been reported.
The suspected cilantro was available at retail locations in California
from January 14 through today. The cilantro was sold in bunches containing
a white twist-tie printed with blue lettering. The twist-ties contain
the words "Produce of USA, Cilantro #4889" and have a blue
Tanimura & Antle logo adjacent to the UPC code 33383 80104.
Symptoms of Salmonella infection include fever, abdominal cramps, and
diarrhea which may be bloody. Most infected people recover within a
week. Some may develop complications that require hospitalization. Infants,
the elderly, and people with weakened immune systems are at highest
risk for more severe illness. People who develop symptoms of Salmonella
infection after consuming cilantro should consult their health care
While the contaminated cilantro may no longer be available in retail
stores, CDPH is concerned that consumers may still have some in their
homes. Consumers in possession of this contaminated cilantro should
not eat it.
Food Handling Breeds GI Outbreaks at Schools
Source : http://www.foodproductdesign.com/news/2011/01/improper-food-handling-breeds-gi-outbreaks-at-sch.aspx
By , (28, Jan, 2011)
TORONTO-Proper and frequent
hand washing by food handlers is key to keeping food-borne illnesses
at bay in schools, according to a new study published in the Journal
of School Health.
Researchers at Ryerson University examined reports published between
1998 and 2008 to identify a number of factors, including the cause of
a gastrointestinal outbreak, how the infection was transmitted, the
number of children affected, mortality rates, and control and prevention
measures. Of the 121 outbreaks cited in the reports 51 percent involved
bacterial infections, 40 percent involved viral infections and 9 percent
involved by one or more parasites. In almost half of the cases, transmission
was identified as being food-borne (45 percent), followed by person-to-person
(16 percent), waterborne (12 percent) and via animal contact (11 percent).
The researchers found that the risk of food-borne illness was reduced
when food handlers practiced effective hand-washing and received food-safety
training and certification. Student-training programs on hand hygiene
and enhanced cleaning and disinfection of schools also were effective
hails chitosan antimicrobial coating potential in curbing Listeria
Source : http://www.foodproductiondaily.com/Quality-Safety/Research-hails-chitosan-antimicrobial-coating-potential-in-curbing-Listeria
By Rory Harrington, (28, Jan, 2011)
Chitosan-based edible coatings
and films have real promise in combating Listeria monocytogenes (LM)
in cold-smoked salmon, according to new research.
The study by Haiqiang Chen et al, published in the Journal of Food Science,
found that use of chitosan, particularly when used in coatings, was
able to inhibit the growth of LM and could potentially be an effective
tool for the fish processing sector in efforts to tackle the bacteria.
The group said they launched the project as LM-contamination of ready-to-eat
foods, such as cold-smoked salmon, is a common cause of foodbourne illness
outbreaks and usually occurs in the post-processing phase. In 2009 the
US Department of Agriculture (USDA) estimated that 15 per cent of all
smoked fish is tainted with LM.
Chitosan is a natural polymer obtained by deacetylation of chitin, which
is the major constituent of the exoskeleton of crustaceans. It is insoluble
in water, but soluble in various acidic solvents such as dilute hydrochloric,
formic, and acetic acids.
The aim of the study was to evaluate the performance of chitosan-based
edible coatings and films incorporating three generally recognized as
safe (GRAS) antimicrobials; sodium lactate (SL), sodium diacetate (SD),
and potassium sorbate (PS), against L. monocytogenes on cold-smoked
Salmon samples were surface-inoculated with a 5-strain cocktail of LM
to a final concentration of 4.4 log CFU/cm2 and then either coated with
chitosan solutions or wrapped with chitosan films with or without the
antimicrobials. The samples were then vacuum packaged and stored at
4¡ÆC for 30 days.
The scientists found that chitosan coatings, with or without the antimicrobials,
consistently showed higher efficacy against LM than chitosan films with
the same compositions.
Chitosan films containing 1.2 per cent SL/0.25 per SD or 2.4 per cent
per SL, achieved ¡Ã 1.3 log reductions of LM during refrigerated storage
period, said the group.
However, chitosan coatings containing 1.2 per cent SL/0.25 per cent
SD or 0.15 per cent PS/0.125 per cent SD, were more effective and achieved
¡Ã 2.8 log reductions.
"Our research thus holds great promise to enhance the microbiological
safety of RTE fishery products," said the study.
Keeping Food Safe During Power Outages
Source : http://gaithersburg.patch.com/articles/tips-on-keeping-food-safe-during-power-outages-3
By Natalie Neumann, (29, Jan, 2011)
It's been more than 60 hours since some people in the area have lost
power. While this may be too late for some, here are some tips offered
by Montgomery County to make sure your food is safe during and following
a power outages.
Meat, poultry, fish and eggs should be refrigerated at 40¡Æ F and frozen
food at or below 0¡Æ F, according to the United States Department of
Agriculture's (USDA) Food Safety and Inspection Service. Storing food
in these temperatures may be difficult with a prolonged power outage.
o Keep the refrigerator and freezer doors closed as much as possible
to maintain the cold temperature. A refrigerator will keep food safely
cold for about four hours if it is unopened.
o A full freezer will hold the temperature for approximately 48 hours
(24 hours if it is half full) if the door remains closed.
o Obtain dry ice or block ice to keep your refrigerator as cold as possible
if there is a prolonged power outage.
o Digital, dial or instant-read and appliance thermometers will help
determine if the food is at safe temperatures. The refrigerator temperature
should be at 40¡ÆF or below; the freezer, 0¡Æor lower.
o To be sure a particular food is cold enough; take its temperature
with a food thermometer.
o Never taste food to determine its safety.
o Food may be safely refrozen if the food still contains ice crystal
or is at 40¡ÆF or below. Evaluate each food item separately. Be sure
to discard any items in either the freezer or the refrigerator that
have come into contact with raw meat juices.
o Food such as meat, poultry, fish, eggs, milk, soft cheeses, butter
and leftover cooked meats, casseroles and pizza should be thrown out
if they have been held above 40¡Æ F for over two hours.
get approval to plant GMO alfalfa
Source : http://www.reuters.com/article/2011/01/28/us-gmo-alfalfa-usda-idUSTRE70R3UP20110128
By Carey Gillam and Christopher Doering, (28, Jan, 2011)
(Reuters) - The United States
said on Thursday farmers could proceed with planting genetically altered
alfalfa without any of the restrictions that opponents say are crucial
to protect organic and conventional farm fields from contamination.
The decision, closely watched by supporters and protesters around the
world for its potential implications on biotech crop regulation, was
seen as a boon to biotech crop developers and comes as research into
additional biotech crops accelerates.
But opponents of biotech crops were disappointed.
The U.S. Agriculture Department had signaled last month that it might
forge a first-ever compromise approval with a range of restrictions
for planting, but there were no such conditions in the plan announced
The USDA said the decision, made by its Animal and Plant Health Inspection
Service, was made after analysis of various economic and environmental
factors, and allows GMO farmers to get their crop in the ground this
"After conducting a thorough and transparent examination of alfalfa
... APHIS has determined that Roundup Ready alfalfa is as safe as traditionally
bred alfalfa," Agriculture Secretary Tom Vilsack said.
Alfalfa is the fourth-largest U.S. field crop grown, worth roughly $8
billion to $10 billion and grown on about 20 million acres as food for
dairy cattle and other livestock.
The decision Thursday to allow planting of genetically altered version
comes after years of court battles with opponents.
Developed by biotech leader Monsanto Co to tolerate treatments of Monsanto's
Roundup herbicide, "Roundup Ready" alfalfa is preferred by
many farmers because it makes killing weeds easier.
But opponents, including conventional and organic farmers, say the biotech
alfalfa can easily contaminate their crops because alfalfa is pollinated
largely by honey bees, making it difficult to isolate GMO fields from
Organic dairy farmers who feed their cows alfalfa say the biotech crop
can kill their business.
Opponents also say increased use of herbicide is translating to increased
weed resistance, and the rise of "super weeds."
A consortium of opponents led by the Center for Food Safety previously
won a court decision against USDA for the government's failure to thoroughly
account for the environmental and economic implications of the biotech
alfalfa when it approved the crop for the first time in 2005.
A federal court ordered USDA to rescind its approval until the government
thoroughly evaluated the impact of the crop.
Vilsack said Thursday the government has now done so, but opponents
said they will sue again.
Make Food Safety Appointments
Source : http://www.foodsafetynews.com/2011/01/more-governors-make-food-safety-related-appointments/
By Dan Flynn, (31, Jan , 2011)
The nation's new governors
are now all at their posts, and most have already delivered their own
"State of State" or budget messages. After last November's
election, 29 executive mansion's are held by the GOP, 20 by Democrats,
and one by an independent, the former Republican, Rhode Island's Gov.
With the executive branches of 26 states now under the command of new
governors, personnel changes are coming fast and furious. Food safety
in state government is often spread across health, agriculture, and
Food Safety News continues today with more reports on these important
Empire state's Gov. Andrew Cuomo has nominated Buffalo native Dr. Nirav
R. Shah as the 15th New York State Commissioner of Health.
Dr/ Shah earned both his medical degree and a master's of public health
at Yale University's School of Medicine.
He takes over from Dr. Richard Daines, who sought extra taxes on soda
pop to fight obesity.
The new commissioner comes to state government from Bellevue Hospital
Center in Manhattan.
Vermont's new Democratic Gov. Peter Shumlin picked Dr. Harry L. Chen
to be Health Commissioner.
Dr. Chen takes over in Vermont for Dr. Wendy Davis.
Chen earned his medical degree and completed his residency at the Oregon
Health Sciences University, where he served a chief resident. He then
served on the faculty of the George Washington University Medical Center's
Department of Emergency Medicine.
In Vermont, he's served as an emergency physician at the Rutland Regional
Medical Center for over 20 years. He was also elected to the Vermont
House of Representatives and served on its Health Care Committee. Chen
has been active in health care reform.
South Dakota Republican Gov. Dennis Daugaard has named Walt Bones as
Secretary of Agriculture.
Bones, with his brothers and nephews, operates a dairy for 2,200 cows
and raises cattle and grain on land near Parker, SD that has been in
the family since 1879.
He succeeds Jon Farris, who has been South Dakota's acting secretary
of agriculture since Bill Even resigned.
SD's Department of Agriculture has programs for plants, eggs, and dairy
to protect consumers and maintain integrity of its brands.
Pennsylvania Republican Gov. Tom Corbett has nominated Dr. Eli Avila
as Secretary of Health.
Dr. Avila was chief deputy commissioner for the Suffolk County Department
of Health Services where he was in charge of more than 1,600 employees
and an annual budget of $400 million.
Avila is a lawyer-doctor, having earned his medical degree from the
Brown University School of Medicine and his J.D. from St. John's University
School of Law. He also has a master degree in public health from the
Mount Sinai School of Medicine at New York University.
Avila replaces Everette James, who left state government last October
to become a Vice Chancellor at the University of Pittsburg.
Wyoming Republican Gov. Matt Mead has re-appointed Jason Fearneyhough
as head of the state Department of Agriculture and appointed Casper
City Manager Tom Forslund to head the state Health Department.
FearneyHough has headed up Wyoming's Ag department for the past 18 months.
Forslund's appointment means Wyoming has an opening for a new state
Dr. Brent Sherard currently is both head department head and the state's
chief health officer. Being a city manager, and not a medical doctor,
Forslund cannot be both the director and health officer.
A department spokesman said it's likely an acting state health officer
will be named from the existing staff when Dr. Sherard departs.
Wyoming was recently named as among a handful of state's as getting
an "A" from the Center for Science in the Public Interest
(CSPI) when it comes to identifying and investigating outbreaks of foodborne
Tennessee Gov. Bill Haslam named Julius Johnson, who has worked for
the state Farm Bureau for almost four decades, as Commissioner of the
Department of Agriculture.
Johnson is a Tennessee native who was a beef cattle farmer before going
on to a career with the Farm Bureau, where he has been chief administrative
officer for the past 15 years.
Johnson took over from former Commissioner Terry j. Oliver.
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