Canada Gazette, Part I, Volume 146, Number 6: GOVERNMENT NOTICES
February 11, 2012
DEPARTMENT OF THE ENVIRONMENT
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Notice is hereby given that, pursuant to section 127 of the Canadian Environmental Protection Act, 1999, Disposal at Sea Permit No. 4543-2-02896 authorizing the loading for disposal and the disposal of waste or other matter at sea is amended as follows:
9. Total quantity to be disposed of: Not to exceed 130 000 m3 place measure.
Acting Regional Director
Environmental Protection Operations Directorate
Prairie and Northern Region
On behalf of the Minister of the Environment
DEPARTMENT OF THE ENVIRONMENT
DEPARTMENT OF HEALTH
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Publication of results of investigations and recommendations for a substance — Decabromodiphenyl Ether — specified on the Domestic Substances List (paragraph 68(b) of the Canadian Environmental Protection Act, 1999)
Whereas decabromodiphenyl ether is a substance listed on Schedule 1 of the Canadian Environmental Protection Act, 1999; and
Whereas an ecological state of the science report on decabromodiphenyl ether was published in the Canada Gazette, Part Ⅰ, on August 28, 2010, and that it was warranted to also update the information regarding human health,
Notice is hereby given that a summary of the draft human health state of the science report on decabromodiphenyl ether conducted pursuant to paragraph 68(b) of the Act is annexed hereto.
Public comment period
Any person may, within 60 days after publication of this notice, file with the Minister of the Environment written comments on the draft state of the science report which may be obtained from the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca). All comments must cite the Canada Gazette, Part Ⅰ, and the date of publication of this notice and be sent to the Executive Director, Program Development and Engagement Division, Gatineau, Quebec K1A 0H3, 819-953-7155 (fax) or email@example.com (email).
In accordance with section 313 of the Canadian Environmental Protection Act, 1999, any person who provides information in response to this notice may submit with the information a request that it be treated as confidential.
Safe Environments Directorate
On behalf of the Minister of Health
Acting Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment
Synopsis of the Draft Human Health State of the Science Report of Decabromodiphenyl Ether
Decabromodiphenyl ether (decaBDE) belongs to a group of structurally related chemicals known as the polybrominated diphenyl ethers (PBDEs). DecaBDE does not occur naturally in the environment and is not manufactured in Canada. However, decaBDE may be imported into Canada as a commercial mixture, DecaBDE, or in consumer products, particularly electronic and electrical goods and textiles. The primary use of decaBDE in Canada is as a flame retardant in the manufacture of thermoplastics and polymer resins.
In 2006, two reports on PBDEs were published: Ecological Screening Assessment Report on Polybrominated Diphenyl Ethers and State of the Science Report for a Screening Health Assessment: Polybrominated Diphenyl Ethers (PBDEs). The conclusion of the ecological screening assessment report was that decaBDE, along with other assessed PBDEs (both reports considered PBDEs containing between 4 and 10 bromine atoms), met the criteria set out in paragraph 64(a) of the Canadian Environmental Protection Act, 1999 (CEPA 1999). On the basis of this conclusion, PBDEs, including decaBDE, were added to Schedule 1 of CEPA 1999.
In August 2010, Environment Canada published an ecological state of the science (SOS) report that examined new environmental data pertaining to the bioaccumulation and transformation of decaBDE. In the present report, Health Canada has examined new human health information that has become available on decaBDE since the original SOS report for a screening health assessment of PBDEs was published in 2006.
The health effects of decaBDE have been well studied. In laboratory animals, decaBDE affects early fetal/neonatal development, the liver, the thyroid and potentially the endocrine system. The available studies suggest that decaBDE does not have significant genotoxic potential, and there is limited evidence for carcinogenicity in experimental animals.
Breast milk is the predominant source of exposure for breast-fed infants. For all other age groups, indoor dust and food were the greatest sources of exposure. Comparison of the critical effect levels for repeated exposures in mammalian studies with the upper-bounding estimates of intake of decaBDE for the potentially most highly exposed age groups (breastfed infants and children aged 0.5–4 years) results in margins of exposure that are considered to be adequate to address uncertainties in the health effects and exposure databases. Comparison of the critical effect level for acute exposure with the upper-bounding exposure estimate for children (aged 0.5–4 years) mouthing hard plastic toys containing decaBDE also results in a margin of exposure considered to be adequate to address uncertainties in the health effects and exposure databases. Additionally, recent unpublished biomonitoring data indicate that levels of decaBDE in human serum in Canada may be lower than the upper-bounding estimates of daily intake. This further supports the adequacy of the margins of exposure derived in this report.
Ongoing ecological risk management initiatives in Canada are expected to result in a reduction of human exposure to decaBDE and other PBDE congeners.
The draft human health state of the science report of decabromodiphenyl ether is available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).
DEPARTMENT OF HEALTH
FOOD AND DRUGS ACT
Notice of Intent — Food and Drug Regulations — Project No. 1663 — Schedule F
The purpose of this Notice of Intent (NOI) is to provide an opportunity to comment on a proposal to add to Part Ⅰ of Schedule F to the Food and Drug Regulations pancrelipase, pancreatin and pancreatic extracts where the strength per dosage unit exceeds 20 000 USP units of lipase activity or when indicated for the treatment of pancreatic exocrine insufficiency. The proposed addition to Schedule F means that all products that contain pancrelipase, pancreatin or pancreatic extracts where the strength per dosage unit exceeds 20 000 USP units of lipase activity or when indicated for the treatment of pancreatic exocrine insufficiency would require a prescription to be sold.
Sections C.01.041 to C.01.049 of the Food and Drug Regulations control the sale of medicinal ingredients that are listed in Schedule F. Part Ⅰ of Schedule F lists ingredients that require a prescription for human use and for veterinary use. Part Ⅱ of Schedule F lists ingredients that require a prescription for human use, but do not require a prescription for veterinary use if so labelled or if in a form unsuitable for human use.
Health Canada has conducted a scientific review of pancrelipase, pancreatin and pancreatic extracts against a set of established and publicly available factors for listing drugs on Schedule F. These factors include, but are not limited to, toxicity, pharmacological properties and therapeutic uses of the medicinal ingredients.
Based on this assessment, Health Canada is recommending the addition of pancrelipase, pancreatin and pancreatic extracts to Schedule F where the strength per dosage unit exceeds 20 000 USP units of lipase activity or when indicated for the treatment of pancreatic exocrine insufficiency. This would result in affected products being regulated as prescription drug products under the Food and Drug Regulations. Since pancrelipase, pancreatin and pancreatic extracts meet the definition of a natural health product, products sold for any other use or at a lower strength would continue to be regulated under the Natural Health Products Regulations.
Pancreatic enzymes are important for the adequate absorption of fat, proteins, and to a lesser extent, carbohydrates from the diet. The failure of the pancreas to produce an adequate level of enzymes results in the inability to properly digest food, otherwise known as pancreatic exocrine insufficiency (PEI). Certain medical conditions can cause this lack of enzymes, including cystic fibrosis, chronic inflammation of the pancreas, or blockage of the pancreatic ducts.
A review of the available scientific literature on pancrelipase, pancreatin and pancreatic extracts indicates that direct supervision by a practitioner and routine laboratory monitoring are required to determine and maintain the optimum dose as the response to these ingredients varies greatly from one patient to another. Testing is needed to determine the level at which these ingredients are effective as there are potential health risks if the dose is excessive. Pancrelipase, pancreatin and pancreatic extracts have been known to cause undesirable side effects such as scarring of the large intestine, which is commonly seen with excessive doses but has occurred at normal therapeutic dosage levels. As a result of this assessment, Health Canada is recommending that pancrelipase, pancreatin and pancreatic enzymes where the strength per dosage unit exceeds 20 000 USP units of lipase activity or when indicated for the treatment of pancreatic exocrine insufficiency, be added to Schedule F and be regulated as prescription status medicinal ingredients under the Food and Drug Regulations.
The following are alternative options to adding the three medicinal ingredients to Schedule F as proposed:
(1) Do not list pancrelipase, pancreatin and pancreatic extracts in Schedule F.
This option is not considered to be appropriate. After measuring these ingredients against the factors for listing drugs on Schedule F, Health Canada is recommending that prescription status would be appropriate for pancrelipase, pancreatin and pancreatic extracts where the strength per dosage unit exceeds 20 000 USP units of lipase activity or when indicated for the treatment of pancreatic exocrine insufficiency.
(2) List pancrelipase, pancreatin and pancreatic extracts in Schedule F without any qualifications, for example, without exemptions.
This option is not considered to be appropriate because it would mean that pancrelipase, pancreatin and pancreatic extracts would require a prescription for all uses and strengths. The only use and strength of pancrelipase, pancreatin or pancreatic extracts that have been identified at this time as meeting the Schedule F factors are where the strength per dosage unit exceeds 20 000 USP units of lipase activity or when indicated for the treatment of pancreatic exocrine insufficiency.
Benefits and costs
The amendment would have an impact on the following sectors:
Prescription access to drug products containing these medicinal ingredients would benefit Canadians by decreasing the risks of improper use and by ensuring the guidance and care of a practitioner.
Another benefit would be that drug products for human use containing medicinal ingredients listed on Schedule F may be covered by both provincial and private health care plans.
- Health insurance plans
Drug products for human use containing medicinal ingredients listed on Schedule F may be a cost covered by both provincial and private health care plans.
- Provincial health care services
The provinces may incur costs to cover practitioners’ fees for services. However, the guidance and care provided by the practitioners would reduce the need for health care services that may result from improper use of drug products for human use that contain medicinal ingredients listed on Schedule F. The overall additional costs for health care services should therefore be minimal.
Following implementation of this initiative, pancrelipase, pancreatin and pancreatic extracts where the strength per dosage unit exceeds 20 000 USP units of lipase activity or when indicated for the treatment of pancreatic exocrine insufficiency could no longer be sold without a valid Drug Identification Number (DIN) and prescription labelling. Notice of this proposed change in regulatory status is being communicated to the pharmaceutical industry through this Notice of Intent. This advance notice, in addition to a delayed coming into force after publication, would allow manufacturers of affected products sufficient time to apply for and, if satisfactory, obtain approval of their DIN submission. A letter will be sent to manufacturers affected by this proposed regulatory amendment which may assist them in beginning the preparation of the documents:
(1) Prescribing Information Part Ⅰ: Health Professional Information;
(2) Part Ⅱ: Scientific Information;
(3) Part Ⅲ: Consumer Information; and
(4) Chemistry and Manufacturing Requirements.
Compliance and enforcement
This amendment would not alter existing compliance mechanisms under the provisions of the Food and Drugs Act, the Food and Drug Regulations and the Natural Health Products Regulations enforced by the Health Products and Food Branch Inspectorate.
The process for this consultation with stakeholders is described in the Memorandum of Understanding (MOU) to streamline regulatory amendments to Schedule F, which came into effect on February 23, 2005. The MOU is posted on the Health Canada Web site.
Health Canada will send the Notice of Intent by email to stakeholders. The Notice of Intent will also be posted on the Health Canada and the “Consulting With Canadians” Web sites.
Any comments regarding this proposed amendment should be sent within 75 days following the date of posting of this NOI on the Health Canada Web site. The policy analyst for this project, Carrie Harrison-Viau, may be contacted at the following address: Refer to Project Number: 1663, Bureau of Policy, Science and International Programs, Therapeutic Products Directorate, Health Canada, Holland Cross, Tower B, 2nd Floor, 1600 Scott Street, Address Locator: 3102C5, Ottawa, Ontario K1A 0K9, 613-948-4623 (telephone), 613-941-6458 (fax), firstname.lastname@example.org (email).
In accordance with the MOU process, it is anticipated that the proposed Schedule F amendment will proceed directly from this consultation to consideration for final approval by the Governor in Council, approximately eight to ten months from the date of publication of this NOI on the Health Canada Web site. If the amendment is approved by the Governor in Council, publication in the Canada Gazette, Part Ⅱ, would follow. The amendment would come into force 90 days after the date of publication in the Canada Gazette, Part Ⅱ.
Assistant Deputy Minister
DEPARTMENT OF INDUSTRY
Revised Competition Act pre-merger notification transaction-size threshold for 2012
Pursuant to subsection 110(8) of the Competition Act, I hereby determine that the amount for the year 2012, for the purposes of any of subsections 110(2) to 110(6) of the Competition Act, is seventy-seven million dollars.
Minister of Industry
NOTICE OF VACANCY
OFFICE OF THE INFORMATION COMMISSIONER OF CANADA
Assistant Information Commissioner (Complaints Resolution and Compliance) [full-time position]
Location: National Capital Region
Salary range: $137,700–$162,000
The Office of the Information Commissioner of Canada was created in 1983 under the Access to Information Act. As an agent of Parliament, the Information Commissioner oversees the implementation of the Access to Information Act by government institutions and is responsible for investigating complaints under the Access to Information Act regarding access to government records and mediates between dissatisfied applicants and government institutions.
Reporting to the Information Commissioner, the Assistant Information Commissioner (Complaints Resolution and Compliance) leads the investigative function of the Office and provides leadership to enhance government-wide compliance with the Access to Information Act.
The successful candidate should have a degree from a recognized university in a relevant field of study, or a combination of equivalent education, job-related training and/or experience. A law degree would be considered an asset. The preferred candidate must have demonstrated decision-making experience with respect to sensitive issues. Management experience in a private or public sector organization, including managing human and financial resources, with experience in the interpretation and application of legislation, regulations and policies, is required. The chosen candidate will also have experience dealing with the Government, preferably with senior government officials, as well as stakeholders and the media.
Knowledge of the mandate, roles and responsibilities of the Office of the Information Commissioner is required. The selected candidate should have knowledge of the legislative and regulatory framework within which the Commissioner carries out his or her mandate, in particular the Access to Information Act, the Privacy Act and their regulations as well as have knowledge of the Canadian parliamentary system and the work of parliamentary committees. Knowledge of relevant government policies on access to information, in addition to emerging access to information issues in Canada and their impact on government, individual Canadians and Canadian society at large, is also required. Knowledge of access to information regimes in other jurisdictions, provincial or international, would be considered an asset.
The successful candidate should be a strong, flexible and tactful leader with sound judgment, objectivity, integrity, strong professional ethics and superior interpersonal skills. The ideal candidate will be able to develop and maintain effective relationships with a broad range of stakeholders, policy makers at all levels, the media and the public at large. The ability to interpret relevant statutes, regulations and policies and analyze complex situations in order to make equitable decisions and recommendations, while anticipating their short- and long-term consequences, is required. The chosen candidate will also have the ability to think strategically, anticipate trends and act to influence the evolution and improvement of the federal access to information regime. Finally, strong communications skills, both written and oral, as well as the ability to act as a spokesperson on access to information issues in dealing with Parliament, the Government, the media and other organizations, are required.
Proficiency in both official languages would be preferred.
The successful candidate must reside in or be willing to relocate to the National Capital Region or to a location within reasonable commuting distance.
The Government is committed to ensuring that its appointments are representative of Canada’s regions and official languages, as well as of women, Aboriginal peoples, disabled persons and visible minorities.
The preferred candidate must comply with the Ethical and Political Activity Guidelines for Public Office Holders. The guidelines are available on the Governor in Council Appointments Web site, under “Reference Material,” at www.appointments-nominations.gc.ca.
The selected candidate will be subject to the Conflict of Interest Act. Public office holders appointed on a full-time basis must submit to the Office of the Conflict of Interest and Ethics Commissioner, within 60 days of appointment, a Confidential Report in which they disclose all of their assets, liabilities and outside activities. For more information, please visit the Office of the Conflict of Interest and Ethics Commissioner’s Web site at http://ciec-ccie.gc.ca.
This notice has been placed in the Canada Gazette to assist the Information Commissioner of Canada in identifying qualified candidates for this position whom she may recommend for appointment to the Governor in Council. It is not, however, intended to be the sole means of recruitment.
Further details about the Office of the Information Commissioner of Canada and its activities can be found on its Web site at www.oic-ci.gc.ca.
Interested candidates should forward their curriculum vitae by March 2, 2012, to the Assistant Secretary to the Cabinet (Senior Personnel), Privy Council Office, 59 Sparks Street, 1st Floor, Ottawa, Ontario K1A 0A3, 613-957-5006 (fax), GICA-NGEC@ bnet.pco-bcp.gc.ca (email).
English and French notices of vacancies will be produced in an alternative format (audio cassette, diskette, Braille, large print, etc.) upon request. For further information, please contact Publishing and Depository Services, Public Works and Government Services Canada, Ottawa, Ontario K1A 0S5, 613-941-5995 or 1-800-635-7943.