Guidance for Responding to the Paragraph 71(1)(B) Notice of Jan

BATCH 4

Guidance document for responding to the CEPA (1999) paragraph 71(1)(b) Notice with respect to Batch 4 Challenge substances, published on November 17,2007

This document provides guidance for responding to the Notice with respect to Batch 4 Challenge substances. This notice was published in the Canada Gazette, Part I, on November17,2007, pursuant to paragraph 71(1)(b) of the Canadian Environmental Protection Act,1999 (CEPA1999). The document is available for guidance only and, in case of discrepancy between this document and the notice or the Act, the notice and the Act take precedence.

On December9,2006, the Minister of the Environment and the Minister of Health (the Ministers) published in the Canada Gazette, PartI, the Notice of intent to develop and implement measures to assess and manage the risks posed by certain substances to the health of Canadians and their environment. The notice of intent identified a list of 193 substances (the Challenge substances) as priority for action. Under the Challenge, these substances have been divided into a number of batches of substances. The Ministers intend to publish, on a quarterly basis, a notice in the Canada Gazette, Part 1, pursuant to paragraph 71(1)(b) of CEPA1999, that requires information regarding the presence or use of Challenge substances that would be identified in the particular notice. The November17,2007 notice requires specific information for the fourth batch, consisting of 18 Challenge substances.

In addition, in the notice of intent, published on December 9, 2006, the Ministers invite the submission of additional information that is deemed beneficial by interested stakeholders, relating to the extent and nature of the management/stewardship of the Challenge substances. A template of a detailed questionnaire is available as an example for the submission of this information. Guidance on how to respond to the Challenge questionnaire is also offered. Stakeholders who wish to do so may submit additional information in respect of the Challenge substances, using this questionnaire.

The November17,2007 notice and all documents related to the collection of information, including the Challenge questionnaire, are available through the Government of Canada Chemicals Substances Web site at http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/index_e.html . An advisory letter, concerning this notice and the collection of information, was sent to a target community of approximately 8000 companies and industry associations.


Information for Completion of the November17,2007 section 71 notice

1. What is the purpose of the notice?

2. Where can I get a copy of the notice?

3. What substances are included?

4. Who is required to respond and what sections need to be completed?

4.1- Do I manufacture?

4.2- Do I import?

4.3- Do I “use” A SUBSTANCE INCLUDED IN THE NOTICE?

5. How to submit a blind submission?

6. What are the Declaration of Non-Engagement and Stakeholder Interest forms?

7. Schedule 3 of the Notice

7.1- How do I report the Total Quantities Manufactured, Imported, Used, Released and Transferred?

7.2- Manufactured Items

7.3- What are the North American Industry Classification System codes?

7.4- What are the Use Pattern Codes?

7.5- What is a Release?

7.6- What is a Transfer to an Off-site Waste Management facility?

8. How to Complete the Sections of Schedule 3

8.1- Section 4

8.2- Section 5

8.3- Section 6

8.4- Section 7

8.5- Section 8

8.6- Section 9

8.7- Section 10

9. Information you may reasonably be expected to have access to

10. How and to whom do I respond and what address?

11. What is the deadline for response?

12. What if I need an extension?

13. Inquiries- whoM to contact

1.  What is the purpose of the notice?

Section 71 notices may be used for the purpose of assessing whether a substance is toxic or capable of becoming toxic, or for the purpose of assessing whether to control, or the manner in which to control, a substance.

The purpose of the current section 71 notice for Batch 4 substances is to identify:

● whether the substances covered under the notice are being manufactured, imported or used in Canada;

● the relative quantities of these substances manufactured, imported, used and released in Canada, as well as quantities transferred to an off-site waste management facility;

● the industrial sectors involved in the manufacture, import or use of the substances;

● the uses of the substances in Canadian commerce;

● the type of mixture, product or manufactured item containing the substances and the top five trade names of these mixtures, products or manufactured items;

·  the concentration or range of concentration of 1,3-butadiene in propane, 2-methyl and butane;

● the concentration or range of concentration of the substances;

● the name and head office street and mailing addresses of the supplier;

● the facility name and street and mailing addresses;

● the procedures and/or policies in place to minimize releases;

● the studies or data that measure the effect of the above procedures and/or policies; and

● the degree of exposure to the substances to individuals in Canada and the environment.

The second major goal is to identify persons, including companies, having current activity with respect to any of these substances, to allow for follow-up and where necessary, to gather more detailed information. The detailed information could include use-pattern information, which will allow for the prioritization of future assessment and/or risk management activities. Requirement for future detailed data collection regarding these substances will be developed, taking into consideration the level of activity and sectors identified in the responses to the notice.

2.  Where can I get a copy of the notice?

The notice was published in Part 1 of the Canada Gazette, pursuant to paragraph 71(1)(b) of CEPA1999 on November17,2007. Electronic copies of the notice can be found on the Web site at the following addresses:

www.chemicalsubstanceschimiques.gc.ca/challenge-defi/index_e.html

3.  What substances are included?

This notice includes a list of 18 substances, identified as Batch 4 in the notice of intent published in the Canada Gazette, Part I, on December9,2006. They have been identified as priorities for action. This list includes:

Batch 4 Substances

Section 1 of Schedule 1 to the Section 71 Notice

CAS RN1 / Name of the substance
64-67-5 / Sulfuric acid, diethyl ester
77-78-1 / Sulfuric acid, dimethyl ester
110-54-3 / Hexane
115-39-9 / Phenol, 4,4’-(3H-2,1-benzoxathiol-3-ylidene)bis[2,6-dibromo-, S,S-dioxide
115-40-2 / Phenol, 4,4’-(3H-2,1-benzoxathiol-3-ylidene)bis[2-bromo-6-methyl-, S,S-dioxide
125-31-5 / Phenol, 4,4’-(3H-2,1-benzoxathiol-3-ylidene)bis[2,5-dimethyl-, S,S-dioxide
1154-59-2 / Benzamide, 3,5-dichloro-N-(3,4-dichlorophenyl)-2-hydroxy-
1176-74-5 / Benzoic acid, 2-[(3,5-dibromo-4-hydroxyphenyl)(3,5-dibromo-4-oxo-2,5-cyclohexadien-1-ylidene)methyl]-, ethyl ester
17321-77-6 / 5H-Dibenz[b,f]azepine-5-propanamine, 3-chloro-10,11-dihydro-N,N-dimethyl-, monohydrochloride
62625-32-5 / Phenol, 4,4’-(3H-1,2-benzoxathiol-3-ylidene)bis[2,6-dibromo-3-methyl-, S,S-dioxide, monosodium salt
64325-78-6 / Adenosine, N-benzoyl-5’-O-[bis(4-methoxyphenyl)phenylmethyl]-2’-deoxy-
68308-48-5 / Amines, tallow alkyl, ethoxylated, phosphates
68443-10-7 / Amines, C18-22-tert-alkyl, ethoxylated
68921-45-9 / Benzenamine, N-phenyl-, reaction products with styrene and 2,4,4-trimethylpentene
70776-86-2 / 2-Butanone, 4-[[[1,2,3,4,4a,9,10,10a-octahydro-1,4a-dimethyl-7-(1-methylethyl)-1-phenanthrenyl]methyl](3-oxo-3-phenylpropyl)amino]-, [1R-(1α,4αβ,10aα)]-
79357-73-6 / Amines, C18-22-tert-alkyl, (chloromethyl)phosphonates (2:1)

Section 2 of Schedule 1 to the Section 71 Notice

CAS RN1 / Name of the substance
75-28-5 / Propane, 2-methyl-
106-97-8 / Butane

Note: Propane, 2-methyl (CAS RN1 75-28-5) and butane (CAS RN1 106-97-8) were included in the fourth batch because they may contain 1,3-butadiene (CAS RN1 106-99-0).

1 CAS RN: Chemical Abstracts Service Registry Number. The Chemical Abstracts Service information is the property of the American Chemical Society and any use or redistribution, except as required in supporting regulatory requirements and/or for reports to the Government of Canada when the information and the reports are required by law or administrative policy, is not permitted without the prior, written permission of the American Chemical Society.

4.  Who is required to respond and what sections need to be completed?

As outlined in Schedule 2 to the notice, the notice applies to any persons who satisfy any of the following criteria:

(a) during the 2006 calendar year, manufactured or imported a total quantity greater than 100 kg of a substance listed in section 1 of Schedule 1 to this notice, whether alone, in a mixture, in a product or in a manufactured item;

(b) during the 2006 calendar year, manufactured or imported a total quantity greater than 100 kg of a substance listed in section 2 of Schedule 1 to this notice containing 1,3-butadiene (CAS RN 106-99-0), whether alone, in a mixture, in a product or in a manufactured item; or

(c) during the 2006 calendar year, used a total quantity greater than 1 000 kg of a substance listed in section 1 of Schedule1 to this notice, whether alone, in a mixture, in a product or in a manufactured item, at any concentration.

Examples:

1) Company meets the reporting threshold:

In 2006, if your company used 210000 kilograms of Product-Z which contained a substance listed in section 1 of Schedule 1 to this notice at a concentration of 5%, the total quantity of the substance used is 10500 kilograms. The reporting threshold is met, regardless of the intended use of the substance.

In 2006, if your company used 2000 kilograms of Product-X which contained a substance listed in section 1 of Schedule 1 to this notice at a concentration of 55%, the total quantity of the substance used is 1100 kilograms. The reporting threshold is met, regardless of the intended use of the substance.

2) Company doesn’t meet the reporting threshold:

In 2006, if your company used 20000 kilograms of Product-Z which contained a substance listed in section 1 of Schedule 1 to this notice at a concentration of 2%, the total quantity of the substance used is 400 kilograms. The reporting threshold is not met.

3) Any use of propane, 2-methyl (CAS RN1 75-28-5) and butane (CAS RN1 106-97-8) should not be reported.

Persons satisfying any criteria are required to provide the information specified in the notice for the 2006 calendar year. Subsection 71(3) of CEPA 1999 states that every person to whom a notice issued under paragraph 71(1)(b) of the Act is directed, must comply with the notice within the time specified in the notice.

If the person subject to the notice is a company, response to the notice must be submitted on a company-wide basis. The responder will include information with respect to each facility in their single response on behalf of the entire company.

Respondents to this notice who,

(a) manufactured a substance listed in section 1 of Schedule 1 to this notice shall complete sections 4, 5(1), 6, 9 and 10 in Schedule 3 to this notice;

(b) manufactured a substance listed in section 2 of Schedule 1 to this notice containing 1,3butadiene (CAS RN 106-99-0), shall complete sections 4, 5(2), and 10 in Schedule 3 to this notice;

(c) imported a substance listed in section 1 of Schedule 1 to this notice, whether alone, in a mixture, in a product or in a manufactured item shall complete sections 4, 5(1), 7(1), 9 and 10 in Schedule 3 to this notice;

(d) imported a substance listed in section 2 of Schedule 1 to this notice containing 1,3butadiene (CAS RN 106-99-0), whether alone, in a mixture, in a product or in a manufactured item shall complete sections 4, 5(2), 7(2), and 10 in Schedule 3 to this notice; or

(e) used a substance listed in section 1 of Schedule 1 to this notice, whether alone, in a mixture, in a product or in a manufactured item, shall complete sections 4, 5(1), 8, 9, and 10 in Schedule 3 to this notice

4.1-  Do I manufacture?

The term “manufacture” in the notice reads as follows:

“manufacture” includes to produce or to prepare a substance; and includes the incidental production of a substance at any level of concentration as a result of the manufacturing, processing or other uses of other substances, mixtures, or products.

This definition relates to the creation/production of a substance, listed in Schedule 1 to the notice. The term “manufacture”, as used in the notice, applies only to the production of the substance itself, and not to that a product or mixture using a reportable substance.

In general, using one or more of the reportable substances to blend or formulate products or mixtures does not meet the definition of “manufacture” under the present notice. However, incidental manufacture of a reportable substance may occur if, during the process of blending or formulating, a chemical reaction occurs that results in the production of a substance (or byproduct) that is reportable under the notice. If so, the incidental production of the reportable substance would meet the definition of “manufacture” under the notice.

4.2-  Do I import?

The term “import” in the notice reads as follows:

“import” includes movement into Canada, including internal company transfers across the Canadian border, but does not include transit through Canada.

Import then relates specifically to the movement into Canada from another country of any substance identified in Schedule 1 to the notice or any mixture, product or manufactured item that contains such a reportable substance.

If you are aware that an imported manufactured item contains a substance included in this notice, you are required to report on this substance if you meet the threshold for reporting. You are required to provide information that your company possesses or to which your company may reasonably be expected to have access.

For the purpose of the notice, possible situations where you are considered to “import” include, but are not limited to, the following examples:

1.  You are an individual, company or other body (in Canada) that ordered or purchased from a foreign supplier, a reportable substance or a mixture, product or manufactured item containing a reportable substance that was shipped directly from a foreign source (such as a person or company situated outside of Canada) to your location in Canada.

2.  You are an individual, company or other body (in Canada) that ordered or purchased from a foreign supplier, a reportable substance or mixture, product or manufactured item containing a reportable substance that was shipped directly from a foreign source to an address in Canada (including a distribution warehouse) on your request.

3.  You are an individual, company or other body (in Canada) that received a reportable substance or mixture, product or manufactured item containing a reportable substance as an internal company transfer from a foreign source.

Individuals, companies or other bodies in Canada that are required to respond can also meet their obligation when a third party is responding on their behalf.