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FDA seminar focuses on preventive controls

The Food and Drug Administration is sponsoring a web seminar on the new Food Safety Modernization Act, with a focus on preventive controls for facilities.
Registration begins April 11 for the April 20 seminar, according to a news release.
Information will be presented by government officials, including:

Michael Taylor, FDA deputy commissioner for foods;
Murray Lumpkin, FDA deputy commissioner for international programs;
Donald Kraemer, chairman of the Implementation Team for Preventive Standards; and
Daniel McChesney, chairman of the Implementation Team for Preventive Standards.
Participants can attend three of five breakout sessions: Preventive Controls Guidance, On-Farm Manufacturing and Small Business, Product Testing and Environmental Monitoring, Training and Technical Assistance, and Preventive Controls and the Relationship to GMPs.
The event is scheduled from 9 a.m. to 5:30 p.m. April 20 EDT time at the FDA White Oak Campus in Silver Spring, Md. The FDA is seeking comments on preventive controls and possible hazards associated with specific types of food and specific processes.
Participants must register to attend in person, for the webcast and to present remarks.

Infant foods safe, says industry, EC confirms wide-ranging trace element review
By Rory Harrington, 14-Apr-2011
UK infant food manufacturers have insisted their products are safe and comply with all regulations, said the sector¡¯s trade body in response to a study this week that raised concerns over levels of trace elements in some products.
The British Specialist Nutrition Association (BSNA) said safety is the primary concern of its members and challenged one of the main assumptions of the research carried out by Swedish scientists that questioned the suitability of including rice in infant food.
The European Commission (EC) and UK Food Standards Agency (FSA) told the levels detected by the study did not give immediate cause for concern. But they highlighted the need to reduce them as much as possible and said a wholesale review process had been launched that was due to report its findings next year.

Valid comparison.
The investigation by the Karolinska Institutet team in Sweden into the concentration of trace elements in nine infant formulas and nine infant foods revealed wide variations between different products intended for babies of less the 4 months old.
Rice-based products were highlighted as being of particular concern because of the levels of arsenic found in them. While no legal limits were broken, the authors said just two portions a day of rice-based infant food would come very close to the former tolerable daily intake of 2.1 ¥ìg/kg bodyweight . a figure now deemed inappropriate by the European Food Safety Authority (EFSA).

But the BSNA questioned the researchers¡¯ comparison between the composition of infant formulas and baby cereals to that of breast milk
¡°Baby cereals are not designed to be breast-milk substitutes and therefore should not be compared to breast-milk,¡± said the body.
It added that minerals and heavy metals that were analysed in the study are all found naturally in the environment and therefore may be naturally present in ingredients. The BSNA said all ingredients were selected to ensure the lowest possible occurrence of the trace elements.
¡°Ingredients that do not meet stringent specifications are not used in baby foods,¡± it added.

Wide-ranging EC review
The EC confirmed that while the levels of lead, cadmium and arsenic in baby foods found in the Swedish study did not ¡°give immediate reason for concern¡°, it declared it was key to reduce them as much as possible.
It has launched a far-reaching review with member states to reassess existing maximum levels for lead and cadmium in food. Existing levels for lead infant formula may be lowered following the evaluation, while those for cadmium in baby food are expected to be introduced for the first time, said Brussels.

Baby foods will be the only food group considered within the review on maximum levels for lead and cadmium. The EC also vowed to scrutinise other foods that are of particular importance for infants and children . such as milk, chocolate, vegetables, cereals and cereal products.

The Commission is further considering introducing harmonised maximum levels for arsenic in foodstuffs. Presently these only exist for drinking water and natural mineral water. Several member states are monitoring arsenic levels in rice and cereals in relation to specific groups such as children as well as on parameters as ¡°origin, varieties and state of processing¡± said the EC.

The EC hopes to complete the cadmium and arsenic reviews by early 2012 while the one for lead is expected later that year.

PLA coating cuts foodborne pathogens on apples
By Rory Harrington, 14-Apr-2011
Applying an antimicrobial polylactic acid (PLA) coating to apples inhibits the formation of foodborne pathogens such as E.coli 0157:H7 and Salmonella, according to new research.
The study by Tony Jin and Brendan A. Niemira said applying the coating to Golden Delicious apples inoculated with E.coli and Salmonella ¡°significantly reduces¡± pathogens on the surface of the fruit.
The scientists said the application of effective antimicrobial methods was necessary ¡°because of the numerous food-borne outbreaks associated with contaminated fruits and the pathogens most likely originate from the contaminated surface of whole fruits¡±.

The study was published in the Journal of Food Science.

In the research, Golden Delicious apples were spot inoculated with E. Coli O157:H7.or S. Stanley and spray coated with PLA solutions containing lactic acid (LA), disodium ethylenediaminetetraacetic acid (EDTA), sodium benzoate (SB), potassium sorbate (PS), or a combination of them all.
The coating were allowed to dry fully, and the apples were stored at 4 ¡ÆC for 14 days. Antimicrobial coatings reduced populations of E. coli O157:H7 and S.Stanley by up to 4 log CFU/cm©÷ at one day and 4.7 log CFU/cm2 at 14 days, compared to controls of uncoated fruit.
The SB + LA combination had a similar effectiveness as the SB + LA + EDTA combination against both pathogens and was more effective than other coating treatments.

Significant reduction
¡°The antimicrobial PLA coating significantly reduced the pathogens on the apple surface,¡± said the research. ¡°In general, the combined treatment of SB + LA or SB + LA + EDTA .was more effective againstE. coli.O157:H7 and.S. Stanley than other coating treatments.¡±
Due the high number of foodborne outbreaks connected to contaminate fruit, the antimicrobial PLA coatings provide an alternative intervention for decontamination of apples. The same technique could also be applied for other fruits, said the scientist.

IIT Opens Institute for Food Safety and Health

The Illinois Institute of Technology's (IIT) on April 11 officially opened its Institute for Food Safety and Health (IFSH), a private-public research consortium dedicated to making foods safer and more nutritious through the use of food science and collaborative research and finding practical solutions to real-world problems. The new institute includes nearly 50 FDA personnel, nearly 50 IIT faculty and students, and more than 50 food industry-related partner companies.

The new institute will create "centers" as separate, but interactive, lines of business comprising the IFSH organizational and administrative structure to streamline research activities and projects to better meet the needs of its members.

To coincide with opening of the new institute, IFSH and the U.S. Department of Agriculture's Agricultural Research Service (USDA-ARS) signed a 5-year memorandum of understanding (MOU) to develop and enhance cooperative farm-to-fork research initiatives. IFSH and USDA-ARS will work closely together to create new, and support existing, cooperative research programs and knowledge exchanges within the broad scope of innovation in food safety, food processing science and human nutrition.

"IFSH's continued partnership with USDA-ARS underscores our organizations' mutual commitment to creating innovative research initiatives that will enhance food safety and nutrition for all consumers," said IFSH Vice President and Director Robert E. Brackett, Ph.D.

IFSH¡¯s principal operating center, the National Center for Food Safety and Technology (NCFST), also entered into a 5-year MOU with Australia's national science agency the Commonwealth Scientific and Industrial Research Organization (CSIRO). Under the agreement, IFSH/NCFST and CSIRO will establish a collaborative framework in which the organizations will provide scientific and technological support to each other in research projects involving food safety, innovative processing technologies, nutrition and health substantiation.

"NCFST will serve as a cornerstone of IFSH, providing a strong, consistent and well-established foundation for the expanded IFSH operating framework. This restructuring strongly positions us to better assist the nation's food companies and regulators with practical, authoritative science-based knowledge, especially in light of new requirements arising from the recent passage of the Food Safety Modernization Act," Brackett said.

NCFST, the Center for Nutrition Research, Center for Processing Innovation, and the Center for Specialty Programs will now operate within the IFSH scientific organizational structure to support continued growth, while leveraging NCFST's leading status as the only center where scientists from an entire FDA division are co-located with university researchers to work side-by-side on food safety, nutrition and technology research projects.

IFSH also launched its new website that reflects the restructuring of NCFST as one of four principal food science research centers operating under the newly formed institute. The website offers a number of online resources, news and public information about the institute's latest activities, state-of-the-art research capabilities and facilities, and staff. Members-only information is accessible from a password-protected log-in window.

EPA Exempts Milk From Spill Control Rule
WASHINGTON.The U.S. Environmental Protection Agency (EPA) on April 12 exempted milk and milk product containers from the Oil Spill Prevention, Control and Countermeasure (SPCC) rule, a move that could potentially save the milk and dairy industries more than $140 million per year.

The regulation has been in place since the 1970s, and yesterday¡¯s ruling for the first time will ensure all milk and milk products will be formally exempted.

After receiving feedback from the agriculture community, EPA determined that this unintended result of the current regulations designed to prevent oil spill damage to inland waters and shorelines placed unjustifiable burdens on dairy farmers. To ensure the outdated rule didn¡¯t harm the agriculture community while the mandatory regulatory process proceeded, EPA had delayed SPCC compliance requirements for milk and milk product containers several times since the SPCC rule went into effect.

¡°After working closely with dairy farmers and other members of the agricultural community, we¡¯re taking commonsense steps to exempt them from a provision in this rule that simply shouldn¡¯t apply to them. Despite the myths that have arisen about EPA¡¯s intentions, our efforts have been solely focused on exempting milk and milk products from this regulation.and that exemption is now permanent," said EPA Administrator Lisa P. Jackson. ¡°This step will relieve a potential burden from our nation¡¯s dairy farms, potentially saving them money, and ensuring that EPA can focus on the pressing business of environmental and health protection."

The final exemption applies to milk, milk product containers and milk production equipment. Because some of these facilities may still have oil storage subject to the spill prevention regulations, EPA also is amending the rule to exclude milk storage capacity from a facility¡¯s total oil storage capacity calculation. EPA also is removing the compliance date requirements for the exempted containers.

Arsenic and toxic metals found in baby foods

By Richard Gray, Science Correspondent and Alastair Jamieson 9:00PM BST 09 Apr 2011
Last night there were calls for urgent new safety rules to control the presence of the poisons in foods intended for young children.
The findings come as officials at the Food Standards Agency and the European Commission are conducting an urgent review to establish new limits for the long term exposure of these contaminants in food.
The products tested by the researchers were made by major baby food manufacturers including Organix, Hipp, Nestle and Holle - some of which are available in British supermarkets.
Researchers found feeding infants twice a day on the shop-bought baby foods such as rice porridge can increase their exposure to arsenic by up to fifty times when compared to breast feeding alone. Exposure to other toxic metals such as cadmium, which is known to cause neurological and kidney damage, increased by up to 150 times in some of the foods tested by Swedish scientists, while lead increased by up to eight times.
Although none of the levels of the toxic elements found in the foods exceeded official safety limits, scientists believe they are still of concern if fed to very young children and have demanded new guidelines to restrict their presence in food.

Young infants are thought to be particularly vulnerable to these substances because they are going through rapid development.
Writing in the journal of Food Chemistry, the scientists from the Unit of Metals and Health at Karolinska Institutet in Stockholm, Sweden, where the research was carried out, said: "Alarmingly, these complementary foods may also introduce high amounts of toxic elements such as arsenic, cadmium, lead and uranium, mainly from their raw materials.
"These elements have to be kept at an absolute minimum in food products intended for infant consumption.
"In infant foods, the high concentrations of arsenic in the rice-based foods are of particular concern." Experts now believe there are no safe limits for arsenic and manufacturers should be making more efforts to remove it from their food.
Professor Andrew Meharg, a biogeochemist at Aberdeen University who has studied the presence of arsenic in rice, said the latest research highlighted the urgent need for new restrictions on arsenic and other toxic elements in food.
He said: "For an adult with an average consumption of rice every day, it makes little difference, but for young babies who are the most vulnerable receptors we should be doing everything we can to reduce that risk. You don't want DNA damage during infant development.
"There are ways to decrease the toxic load in food. It is only recently that we have started using rice in baby foods and formulas. You can reduce the arsenic in infant foods very rapidly by sourcing the rice from different parts of the world. You can reduce it by four or five fold by carefully selecting the right rice."
The researchers tested nine different brands of baby food, which were intended to be fed to children from the age of four months old, and nine baby milk formulas.
They found that when compared to breast milk, the baby foods had elevated levels of toxic contaminants measured in micrograms - a millionth of a gram, or 35 billionths of an ounce.
The daily safe intake limit for arsenic was set by the World Health Organisation as two micrograms for every kilogram of body weight, but this was suspended earlier this year amid growing evidence that arsenic can cause cancer even at low levels.
The limits for lead have also been suspended while those for cadmium are one microgram for every kilogram of body weight.
Arsenic and the other heavy metals found in the study are often found in food as they are absorbed from the soil by plants such as rice, wheat and oats.
Among the baby foods found to contain elevated levels of arsenic, cadmium and lead in the tests by the researchers was Organix First Organic Whole Grain Baby Rice, which they found contained two micrograms of arsenic per portion, along with 0.03 micrograms of cadmium and 0.09 micrograms of lead. This product is sold by Boots in the UK.
HiPP Organic Peach and Banana Breakfast porridge, which is sold by supermarkets in the UK including Tesco, contained 1.7 micrograms of arsenic, 0.13 micrograms of cadmium and 0.33 micrograms of lead.
Holle Organic Rice Porridge, which is sold by specialist retailers, was found to contain 7.3 micrograms of arsenic per portion - the highest found in the study - along with 0.38 micrograms of cadmium and 0.26 micrograms of lead.
The Swedish National Food Administration is now conducting its own review of toxic elements and metals in baby food and food for older children as a result of the research. The results will be reported to the European Food Safety Authority and the European Commission, which is responsible for setting food safety limits.
The Sunday Telegraph contacted each of the major manufacturers of leading brands of baby food sold in the UK but most refused to reveal the levels of toxic contaminants found in their products. Heinz, Cow & Gate, Nestle, and HiPP all insisted their foods contained levels that were within safety limits.
Dr Karin Ljung, who led the Swedish research, said: "The producers will say they are not above any guideline values and it is true . they are following all the rules.
"The trouble is that the guidelines are not based on infant exposure. As we are getting more information coming out, it is may be time to reconsider what these safety limits are."
She added that breast feeding until babies were six months old appeared to be the best way to keep infants' exposure to these toxic contaminants as low as possible as they seemed to be filtered out by the mothers' body.
There are currently no EU-wide regulations for arsenic levels in food after the European Food Safety Authority ruled that previous safety limits were inadequate.
Jackie Schneider, from the Children's Food Campaign, said: "We expect full transparency from baby food manufacturers and are disappointed that they are choosing to not share the relevant data.
"Parents aren't stupid and they deserve to be given the facts so they can make an informed choice"
A spokesman for the Food Standards Agency said previous reviews of the levels of toxic elements in baby food found them to be present at low levels.
He added: "The Agency is actively engaging with the European Commission to review and establish long term limits for these environmental contaminants in food."
A spokesman for the British Specialist Nutrition Association, the trade body for baby food producers in the UK, said: "BSNA members carefully select and control their ingredients as well as the baby food, to ensure they are safe for infants.
"That selection of suitable ingredients ensures the lowest possible occurrence of certain naturally-occurring substances. Ingredients that do not meet stringent specifications are not used in baby foods."
A spokesman for HiPP insisted the levels of arsenic and cadmium in their Organic Peach and Banana Breakfast porridge were under the official daily intake limits and so were safe as part of a daily diet.
She said: ¡°The levels of cadmium and arsenic in HiPP products are safe and all raw materials are routinely tested following the strictest quality criteria.¡±
A spokesman for Organix said: ¡°Organix operates rigorous finished food testing to ensure food safety is monitored regularly. This includes testing for elements, microbiological, allergen and pesticide residues.
¡°Our further testing of finished foods and raw materials show ALL results conform to the current UK food standard. We continue to monitor both our own internal results together with those of our suppliers.
¡°Please rest assured that we fully assess both the Food Standards Agency¡¯s guidelines and any new research and will continue to do so.¡±
A spokesman for Plum added: ¡°Sampling of our recipe shows levels for arsenic are well below those in this latest study, and again these are well within the generally regarded safe and acceptable limits.¡±
Nestle said it did not recommend the use of it infant cereals before six months of age, but they carefully selected their raw materials to ensure substances absorbed from the soil were as low as possible.

Low Levels of Radiation Detected in UK Foods
LONDON.The Food Standards Agency announced April 7 that radiation levels from the Fukushima nuclear plant accident in Japan are far too low to cause any concerns over the safety of any food in the United Kingdom.

According to FSA, there is a possibility that minute levels of iodine-131 could land on grass and be consumed by cows, but at these levels there is no food safety risk. Minute amounts of iodine-131 could also settle on the surface of vegetables but this will not cause any food safety concerns and will soon decay or be washed away. Analysis of milk samples taken in Scotland did not detect any iodine-131.

Food imported to the European Union from Japan is undergoing extra checks in addition to the routine monitoring of imported food that takes place. Only 0.1 percent of food imports received by the United Kingdom come from Japan and any food that is found to have levels of radiation above the legal limits will be prevented from entering the country.

EU steps up import controls on food from Japan again
The European Union has further strengthened import controls on food from Japan in the wake of the nuclear disaster triggered by the devastating tsunami last month.

Brussels announced Friday that it had lowered the acceptable maximum levels of certain radioactive elements in food and feed; namely iodine-131, caesium-134 and caesium-137.

Officials said the measure was a precautionary one and had been adopted to match new lower acceptable levels introduced by Japanese authorities.

The situation could also prompt a summer overhaul by EU experts over maximum radiation levels in food first set 24 years ago after the Chernobyl nuclear catastrophe.

The move follows the European Commission declaration on 25 March that food and feed imports from 12 Japanese prefectures would have to be accompanied with safety certificates and be subject to random testing at EU borders. An early warning system also requires importers to give competent authorities in the bloc two days notice of a consignment¡¯s arrival.

The updated measure, backed by member states on the Standing Committee on the Food Chain and Animal Health (SCoFCAH), will apply to foodstuffs originating in . or transported from . those 12 Japanese areas. All products from these prefectures are to be tested before leaving Japan and are subject to a reinforced testing regime in the EU.

Shipments from the remaining 35 prefectures have to be accompanied by a declaration indicating the prefecture of origin, before being randomly tested upon arrival in the EU.

The EC stressed that the ¡°precautionary nature¡± of the boosted regulation and said notes ¡°all the checks carried out up to now by Member States of Japanese food imports demonstrate negligible levels of radio-activity, which are significantly below existing standards¡±.

It added that Japanese authorities had confirmed food exports from the 12 prefectures into the bloc had all but ceased following the disaster.

Higher than 10 per cent
Until now, Japanese food imports were obliged to comply with universally applicable levels set in the aftermath of the Chernobyl nuclear accident in 1987 under various Euratom regulations . covering infant food, dairy products, as well as general, liquid and so-called ¡®minor¡¯ foodstuffs.
These limits are based on the assumption that, if 10 per cent of the food consumption of a person over a full year were contaminated at these levels, annual exposure to ionising radiation would not exceed the additional annual dose limit for a human being of 1 mSv (milliSievert).

Japan, however, has recently imposed lower values for food on the domestic market.

The EU said it had followed suit because: ¡°It has to be considered that in the current situation in Japan, a much higher percentage (than the 10 % on which the EU levels are based upon) of the population's daily diet could be contaminated with significant levels of radio-nuclides¡±.

It will also provide consistency between the pre-export controls performed by the Japanese authorities and EU tests on the level of radio nuclides entering the region.

Radiation level change.
The EC said the measures would be reviewed on a monthly basis but that controls could be toughened further within 48 hours if necessary.
It confirmed that its experts would be meeting before 30 June, 2011 to decide if the maximum levels set out in Regulation (Euratom) 3954/1987 needed to be revised.

E. coli walnut recall expanded to Calgary
A walnut recall due to the possibility of E. coli contamination has been expanded to include Calgary.

The Canadian Food Inspection Agency warns members of the public not to consume raw shelled walnuts imported and distributed by Montreal's Amira Enterprises Inc.

The walnuts were sold in Calgary at Jimmy's A & A Mediterranean Deli located at 1401 20 Ave N.W. in 500-gram plastic containers from Jan. 1 to April 5.
They were also sold by two retailers in London, ON.
One person in Quebec died after eating the walnuts. The product was taken off the shelves in Quebec, Ontario and the Maritimes. Thirteen people in those provinces got sick from the walnuts.

The agency warns that consumption of food contaminated with E. coli can cause serious, potentially life-threatening illnesses, and even death.
Symptoms include abdominal pain, bloody diarrhea, and some people suffer seizures or strokes.
For more information, please call the agency at 1-800-442-2342 / TTY 1-800-465-7735.

Hazelnut Outbreak Affected Eight in Three States
by Mary Rothschild | Apr 11, 2011
The three-state outbreak of E. coli O157:H7 linked to hazelnuts sickened at least eight people, the Centers for Disease Control and Prevention (CDC) reported late last week.
The CDC had previously reported 7 ill with the outbreak strain.
In its update on the outbreak investigation, the CDC said product tests by the Minnesota Department of Agriculture on in-shell hazelnuts, by the California Department of Public Health on mixed nuts that included unshelled hazelnuts, and by the Wisconsin Department of Health Services on mixed nuts that included unshelled hazelnuts all detected E. coli O157:H7 matching the outbreak strain.
Earlier epidemiologic investigations in Michigan, Minnesota and Wisconsin had traced the hazelnuts, most of which had been purchased from grocery store bulk bins, to a common distributor: DeFranco & Sons in Los Angeles.
DeFranco recalled its bulk and packaged in-shell hazelnuts on March 4. The company had distributed the nuts nationwide.
The CDC said four of people infected with the outbreak pathogen were from Wisconsin, three were from Minnesota and one was from Michigan. They ranged in age from 15 to 78. Six were male. Half of the case patients had illnesses so severe they were hospitalized, but none reported hemolytic uremic syndrome.
The onset of their illnesses ranged from Dec. 20, 2010 to Feb. 16, 2011. CDC believes this outbreak is now over, but said illnesses that occurred after March 17 might not yet be reported due to the time it takes between when a person becomes ill and when the illness is reported.

It is past time for the USDA/FSIS to deem "the Big Six" E. coli as adulterants
Posted by Bill Marler on April 12, 2011
Print Discuss (3) Share In October 2009 that we filed a ¡°Petition for an Interpretive Rule Declaring enterohemorrhagic Shiga Toxin-producing Serotypes of Escherichia coli, Including Non-O157 Serotypes, to be Adulterants Within the Meaning of 21 U.S.C. ¡× 601(m)(1)¡± with the Food Safety Inspection Service (FSIS). Since I filed the Petition, I have also filed two supplements (See, First and Second) and provided the FSIS with my private test results.

When I filed the Petition, Mead, et. al., estimated that non-O157 STECs (like O26, O45, 0103, O111, O121, and O145) caused 36,000 illnesses, 1,000 hospitalizations and 30 deaths in America each year. Now, admittedly, not all, or most of these illnesses and deaths were caused by vectors overseen by FSIS, but clearly some have. However, the CDC new estimates of illnesses caused by non-O157 STECs have risen to over 160,000 ill yearly. Hospitalizations and deaths are lower because many non-O157 STECs do not cause severe illness, but O26, O45, 0103, O111, O121, and O145 certainly do.

Today the USDA/FSIS posted this press release:

Almost everyone knows about Escherichia coli O157:H7, the culprit behind many headline-making outbreaks of foodborne illness in the United States. But the lesser-known relatives of this pathogenic microbe are increasingly of concern to food safety scientists.

That's according to U.S. Department of Agriculture (USDA) microbiologist and research leader Pina M. Fratamico. Researchers such as Fratamico, along with food safety regulators, public health officials and food producers in the United States and abroad, want to know more about these less-studied pathogens.

In the past few years, a half-dozen of these emerging E. coli species, also called "serogroups," have come to be known among food safety specialists as "the Big Six," namely E. coli O26, O45, O103, O111, O121, and O145.

Fratamico and her colleagues are sorting out "who's who" among these related pathogens so that the microbes can be identified and detected quickly and reliably. The researchers are doing that by uncovering telltale clues in the microbes' genetic makeup.

Building upon this work, Fratamico and her Agricultural Research Service (ARS), university, and industry collaborators have developed gene-based PCR (polymerase chain reaction) assays for each of the Big Six. With further work, the assays might be presented as user-friendly test kits for use by regulatory agencies and others. Foodmakers, for example, might be able to use such kits for in-house quality control, while public health agencies might rely on them when processing specimens from patients hospitalized with foodborne illness.

Analyses of test results might help researchers determine whether certain strains of Big Six E. coli species cause more illness than E. coli O157:H7 does, and if so, why.

The USDA/FSIS has been studying this issue for years while people continue to become ill. Tests that work have been available for years . I have $500,000 worth of examples. The USDA/FSIS has the authority to deem at least the ¡°the Big Six¡± adulterants despite some in the industry desire to not do so. It is time to - past time . to act.


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