Food, Drug and Cosmetic Update

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 Mandatory Licensing and Safety Standards for Food Premises in Manitoba

By  Nicole J. Kutlesa

Late last year, the Manitoba legislature introduced Bill 7, The Food Safety and Related Amendments Act, which received first reading on December 3, 2008 (the Bill). If passed, the Bill will require the licensing of food establishments and set out mandatory reporting obligations of food establishment operators. In addition, the Bill will enable the government to establish standards and requirements for food, food premises and food safety systems, and will make it an offence to sell or distribute a food that is identified as a food safety risk. Finally, the Bill will provide the government with certain recall and order-making powers.

Application

The Bill would apply to “food premises” which includes not only premises where food is grown or produced, but also any premises where food is processed, prepared, packaged, distributed, transported, sold, stored or handled for any of these purposes. This definition will capture manufacturing and packaging plants, storage/distribution warehouses, restaurants, cafeterias, etc. and includes vehicles. Furthermore, the Bill will apply to food or beverage for human consumption, including ingredients, unless the regulations provide for a specific exception.

Responsibility for Food Safety

The Bill provides a definition of a “food safety risk” which applies to food as well as to agricultural inputs (e.g., feed, fertilizers, pesticides, manure, supplements, growth promoters, etc.). It also creates an offence for an operator of food premises who sells or distributes any food that is a food safety risk. The “sale” of a food by definition includes offering and displaying a food, possessing or delivering a food for the purposes of sale, bartering or exchanging food and offering food as a prize or reward. The Bill also creates mandatory reporting obligations of operators who reasonably believe that a prescribed food safety risk exists on their premises. The Bill encourages voluntary reporting by employees (and other individuals) by creating whistleblower protection for employees who, in good faith, report their reasonable beliefs that a food safety risk exists on their employer’s food premises.

Mandatory Licensing

The Bill would require that certain designated types or classes of food premises be licensed. Such licenses would be non-transferable and may be subject to terms and conditions as imposed by an appointed director. The creation of a public registry of licensed establishments is also contemplated under the Bill.

Inspections and Orders

Under the Bill, food premises will be subject to spot-inspections at any reasonable time and without notice by Minister-appointed inspectors. Inspectors will be charged with general inspection powers (i.e., premises entry, sampling and testing, operation of equipment on premises, record inspection and production, copying, photographing), as well as search and seizure powers under certain circumstances. Inspectors will also be able to issue orders where they reasonably believe a food safety risk exists and an order is necessary to prevent, control or eliminate the risk, or where a person has failed to comply with the legislation. An order may (among other things) direct a person to:

  • (1) clean or disinfect premises or equipment;
  • (2) modify or not use certain equipment, ingredients or agricultural inputs;
  • (3) destroy or remove a food or other item; and
  • (4) modify or stop operations, including selling or distributing food from the premises.

An order issued by an inspector may not, however, require a person to recall any food or agricultural input. A review process will be available for most types of orders.

Recalls

Under the Bill, only the minister, on reasonable grounds, may order a recall, withdrawal or quarantine of a food or an agricultural input, and only after consulting with the chief provincial public health officer and in accordance with the regulations. The Bill also enables the minister to establish a “control area” within, from or to which certain persons may be prohibited or restricted from selling, transporting or distributing food or agricultural inputs. It is an offence for an individual to fail to comply with such orders.

Standards and Requirements

The Bill provides that regulations may be created to establish standards and requirements for food, including the preparing and packaging, marking and labelling, displaying and selling of food. Regulations may also be created concerning:

  • (1) food premises (i.e., requirements for the location, design, maintenance and sanitation of food premises, production practices used, control and supervision of food premises, and qualifications and training of staff);
  • (2) food safety systems and programs (i.e., monitoring and auditing practices);
  • (3) record-keeping and the reporting obligations of operators;
  • (4) food-origin tracking systems; and
  • (5) the disposal of food by-products.

Enforcement

Failure to comply with a prescribed provision of the legislation may result in an administrative penalty issued by an inspector of up to $5,000. The director may also issue public reports disclosing the details of any administrative penalties issued. Individuals who commit an offence under the legislation – which can include officers, directors, employees or agents of a corporation who authorized, permitted or acquiesced in the commission of the offence – may be liable for a fine of up to $50,000 and/or a six-month term of imprisonment. Corporations may be liable for a fine of up to $500,000.

 Toronto Considering Trans Fat Ban

By  Nicole J. Kutlesa

As an update to our coverage of Canadian trans fat initiatives exactly one year ago in the February 2008 Osler Franchise Review, with the Calgary trans fat initiative boasting a 97% compliance rate, Toronto public health officials are now looking to adopt a similar regulatory approach in the absence of federal regulation. In late January, the Toronto public health board ordered a survey, to be conducted by public health food inspectors later this year, on the trans fat content of food at local restaurants and supermarkets. The federal government’s voluntary program requesting the food industry to reduce trans fats to specified limits within two years expires in June 2009. Toronto public health officials are warning that, depending on the outcome of their survey and in the absence of federal regulation, local regulation – which will likely include an outright ban on trans fat – can be expected.

 You Are What You Eat: Food Product Labelling Bill Reinstated

By  Meredith Ashton

Bill C-205, An Act respecting the labelling of food products, received First Reading in the House of Commons on November 21, 2008 and died on the order table on December 4, 2008 when Parliament was prorogued. On January 26, 2009 in the Second Session of the 40th Parliament, the Bill was reinstated at First Reading. The Bill requires the Minister of Health to make regulations within nine months of the Act coming into force which would require a label to be affixed to all meat or poultry products or their packaging which clearly identifies that the products were produced using hormones, antibiotics or rendered slaughterhouse waste. A label would also be required to be affixed to any food product or its packaging to clearly show that the product was produced using pesticides or genetically modified organisms.

 Government Proposes Ban on Common Cosmetic Ingredients

By  Nicole J. Kutlesa

On January 31, 2009 Environment Canada and Health Canada (Government) released their joint final decision on the screening assessment of a series of 16 chemical substances (Batch 2 chemicals) as part of Canada's Chemicals Management Plan. The Plan was initiated in 2006 to assess the safety of certain priority chemicals on the Domestic Substances List that were identified as potentially harmful. (There were 17 substances in Batch 2 when it was originally released as part of the initiative on May 12, 2007. The final screening assessment conclusion for one substance in Batch 2, Bisphenol A, was released on October 18, 2008.)

CEPA Toxic Substances

Of the 16 remaining Batch 2 substances, the Government concluded that two substances – Cyclotetrasiloxane, octamethyl- (D4) and Cyclopentasiloxane, decamethyl- (D5) (also known as cyclomethicone) – commonly found in consumer products such as shampoos, conditioners and antiperspirants meet one or more of the criteria set out in the Canadian Environmental Protection Act, 1999 (CEPA) as a "toxic" substance. As a result, the Government has recommended that these substances be added to Schedule 1 of CEPA (toxic substances). It will consider imposing regulations to limit the quantity or concentration of D4 and D5 contained in certain personal care products and other consumer products manufactured in and imported into Canada.

In addition, isoprene and epichlorohydrin (and the two hair dyes that use epichlorohydrin in their manufacture - HC Blue No. 5 and HC Blue No. 4), both commonly found in cosmetic products, are proposed to be added to Canada's Cosmetic Ingredient Hotlist, which will prevent their future use in cosmetics. Following the screening assessment, both substances were designated as carcinogens.

On February 20, 2009 screening assessments for 19 chemical substances included in Batch 5 of the Plan were also released. Two of these substances are proposed to be of concern to human health. Specifically, the Government is also proposing to add acrylamide to Schedule 1 of CEPA (toxic substances). Acrylamide is used to make polymers commonly found in cosmetics (as well as grout, cement, diapers and other products). It is also commonly found in processed fried foods (such as french fries and potato chips) as a result of a chemical reaction when certain ingredients are exposed to high cooking temperatures. At this time, the Government has not proposed a risk management approach for acrylamide, but has indicated that it plans to use the Food and Drugs Act "to reduce the inadvertent production of acrylamide in certain processed foods intended for human consumption."

The Government is inviting comments from industry and other interested stakeholders on its proposed risk management approach for the Batch 2 substances until April 1, 2009. Draft regulations are expected by January 2011. For more information on Batch 2 substances and proposed risk management approaches, click here . Comments on the proposed addition of acrylamide to CEPA’s toxic substances list will be received until April 22, 2009. For more information on the risk assessments for the Batch 5 substances, click here.