Politicians talk about reducing the regulatory burden.
But in the food industry, they're piling on new regulatory burdens.
Outlines about two more sets were provided by speakers at the Spring Technical Conference put on by the Ontario Food Protection Association in Mississauga today.
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| Frank Massong |
Frank Massong, who joined Paul Valder Consulting three years
ago after a career with the Canadian Food Inspection Agency, outlined much
stiffer regulations governing allergens and in particular the claim that a
product is gluten free.
Allen R. Sayler, president of the Center for Food safety and
Regulatory Solutions in Virginia, said Canadian companies are about to face a
whole new set of Food and Drug Administration regulations and said even
companies that don’t have customers in the U.S. will eventually be impacted.
Massong’s chief client is the Canadian Celiac Association
and he said it offers to put its logo of compliance on products if companies
comply with its standards which will automatically result in compliance with
the upcoming Canadian regulations.
One of the major changes is that foods claiming to be gluten
free must, in fact, be gluten free. The association, which represents about
30,000 Canadians with severe allergic reactions to gluten and another 300,000
who experience some degree of discomfort, says that up to 20 parts per million
can be tolerated by most of its members.
However, Health Canada, which sets the standard, has not
announced a tolerance level under the new regulations which take effect Aug. 4.
That means that the Canadian Food Inspection Agency could condemn any
“gluten-free” product that contains any gluten – i.e. zero tolerance.
What’s more alarming is that any food that does not list
wheat, barley, oats, triticale or rye as an ingredient will be deemed to be
claiming to be gluten free and could be disciplined if any gluten is found in
its products, Massoud warned.
The gluten standard, including the tolerance issue, has been
under discussion at Health Canada and with the food industry for at least a
decade.
The new regulations add mustard seed to the allergen list.
The U.S. doesn’t list either mustard seed or sesame seed as an allergen, so the
standard for exporting is different.
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Allen R.Sayler |
Sayler said the Food Safety Modernization Act passed last
year “is really going to rock the U.S.” and Canadian companies marketing
products and ingredients to food processors in the U.S.
And he said eventually “regulatory creep” will result in
Canada’s federal and provincial jurisdictions enacting regulations similar to
the new ones in this modernization act.
He said there was nothing wrong with the previous Food and
Drug Administration Act’s regulations, but there was a lack of enforcement.
That and a number of high-profile food-poisoning issues prompted politicians to
revamp the legislation.
They were completing their drafting and debating just as the
tsunami destroyed nuclear reactors in Japan, so the new act adds radioactivity
to the standards the industry must now meet.
He said lead and mercury both carry radioactivity, so food
processors should be checking radioactivity levels of raw materials they
purchase from suppliers.
He said food processors will be able to avoid a lot of
hassles by purchasing from brokers and holding them accountable under
traceability standards that are one step back and one step forward. However, he
said brokers will be shaken because they’re going to have to check all of their
many suppliers and reveal their identities to Food and Drug Administration
inspectors and enforcers if and when they ask.
The FDA is gaining far greater authority to demand
information and records from food processors, but Sayler said it might not be
much different from what the Canadian Food Inspection Agency can already
require Canadian companies to produce.
Canadian companies will have to register with the Food and
Drug Administration to be able to export to the U.S., and will have to renew
that registration every two years.
Among registration requirements will be
information about employee training and proof that they have been trained plus
what amounts to a HACCP (Hazard Analysis Critical Control Points) program,
although it isn’t called that in the act or regulations. “It just amounts to
the same thing,” Sayler said.
He guesses the FDA will be charging a registration fee and
guesses it will be about $50. He also expects other, and quite burdensome, fees
for recalls. The FDA gains the authority to order a recall; in the past it
could pressure companies into a voluntary recall, including issuing a news
release about the product and issue that prompted them to request a recall.
When there’s a recall, the store shelf space must be emptied
and left empty for two weeks, and there must be a sign in that space saying the
product was recalled.
The FDA gains the authority to detain any product it
suspects could be a food-poisoning hazard, and to hold it for 30 days. There is
an appeal process, but it takes 30 days.
Saylor cited a Toronto study that found that campylobacter
bacteria are by far the most common pathogen in foods, followed by salmonellas
and yersinia.
Under the upcoming U.S. regulations, companies must report
any positive results for harmful bacteria within 48 hours. He expects the
laboratories that conduct the testing for companies will be required to
provide copies of the results to
the FDA.
He said food processors must have an employee training
program, an environment-monitoriong program (eg. swabbing and testing for
harmful bacteria), a Good Manufacturing Practices protocol, an allergen control
program and documented evidence that they are in compliance with these policies
and programs.
He said that the new FDA power to see all records when
there’s a recall or problem at a facility might prompt competitors to file a
Freedom-of-Information request to see those documents, so he advises companies
to “stamp all records confidential, not for public disclosure!”
He said financial, personal, pricing, sales and research
data remains confidential and these records do not have to be provided to FDA
inspectors.
He said the FDA has yet to reveal almost all of the
regulations that will apply to importers – i.e. Canadians – but last July the
FDA said all importers will have to meet all of the regulations that will apply
to domestic companies, facilities and products.
He advised Canadians to contact the FDA to find out what
will be expected of them and to register any concerns they have about those
requirements as soon as possible.
One of the issues raised by a questioner is whether the FDA
will accept Canadian laboratories that are certified by the Standards Council
of Canada.
Sayler recommended that the Standards Council talk to the
FDA about lab accreditation and how that applies to its Canadian customers.
