Proposed environmental performance agreement for the formulation of chlorhexidine products

Proposed environmental performance agreement for the formulation of chlorhexidine products (“agreement”)

between

Her Majesty the Queen in Right of Canada, as represented by the Minister of the Environment (“Environment and Climate Change Canada” or “ECCC”)

and

Participating companies

Alternate formats

Preamble

Whereas in order to determine whether or not they are toxic or capable of becoming toxic to the environment or human health, the Minister of the Environment and the Minister of Health have conducted a screening assessment of chlorhexidine and its salts, including, but not limited to:

CAS Registry Number Substance
55-56-1 Chlorhexidine
56-95-1 Chlorhexidine diacetate
3697-42-5 Chlorhexidine dihydrochloride
18472-51-0 Chlorhexidine digluconate

Whereas the Minister of the Environment and the Minister of Health have concluded that chlorhexidine and its salts meet the criteria under paragraph 64(a) of the Canadian Environmental Protection Act, 1999 (CEPA) as they are entering or may enter the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity;

Whereas it was concluded that chlorhexidine and its salts do not meet the criteria under paragraph 64(b) of CEPA as they are not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger to the environment on which life depends and do not meet the criteria under paragraph 64(c) of CEPA as they are not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health;

Whereas it has been determined that the chlorhexidine and its salts meets the persistence criteria but not the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations of CEPA;

Whereas the characterization of the ecological risk indicates that releases of chlorhexidine moiety in the aquatic environment from the industrial formulation of chlorhexidine-based products pose a risk to aquatic and benthic organisms;

Whereas participating companies use chlorhexidine and its salts in the industrial formulation of chlorhexidine-based products in Canada and their releases of chlorhexidine moiety may pose a risk to the environment;

Whereas the Minister of the Environment recognizes voluntary action of industry as an efficient means to achieve environmental objectives;

Whereas Provincial, Aboriginal Governments and stakeholders of non-government organizations were informed about the publication of the proposed agreement as part of this consultation process;

And whereas participating companies are willing to work with ECCC towards reducing the contribution of chlorhexidine moiety released from their facilities to levels that are protective of the environment;

The parties to this agreement agree as follows:

1. Purpose

The purpose of this agreement is to protect the aquatic environment by minimizing participating companies’ releases of chlorhexidine and its salts, from their facilities that formulate chlorhexidine-based products.

2. Definitions

In this agreement:

Chlorhexidine moiety

The chlorhexidine molecule without the salt. Chlorhexidine salts dissociate (split apart) in water, releasing the chlorhexidine moiety.

Facility

An industrial facility using chlorhexidine and its salts to formulatechlorhexidine-based products.

Final discharge point

An identifiable discharge point beyond which a participating company no longer exercises control over quality of the effluent.

Normal operating conditions

Conditions that are representative of regular or typical operating conditions related to the formulation of chlorhexidine-based products.

Participating company

A company that owns 1 or more facilities using chlorhexidine and its salts to formulate chlorhexidine-based products and that has signed the “list of participating companies” found at Annex A to this agreement.

3. Non-binding agreement

3.1 This agreement represents an understanding between ECCC and participating companies. It is not intended to create legally binding obligations and is therefore not legally enforceable.

3.2 This agreement does not preclude participating companies from implementing any other environmental initiatives or measures as it sees fit. Adherence to this agreement does not in any way exempt participating companies from complying with all applicable laws and regulations.

3.3 This agreement does not preclude ECCC from taking other measures or actions, including making laws, or enforcing the existing laws of the Government of Canada.

3.4 Participating companies agree to participate fully in this agreement to attain the objective of minimizing the release of chlorhexidine and its salts from their facilities to levels that are protective of the aquatic environment as set out in this agreement.

3.5 ECCC may add other companies that release chlorhexidine and its salts in a concentration that may result in levels that are not protective to the environment as a party to this agreement.    

3.6 This agreement will apply to the successors or assignees of the parties.

3.7 In the event that a company is no longer a party to the agreement, the agreement shall survive and remain in effect for the remaining parties.

4. Duration, amendment and termination

4.1 Participating companies agree to be subject to this agreement by signing “Annex A: list of participating companies”.

4.2 The agreement is in effect until XXX, XXX, 2028.  

4.3 The term of agreement may be extended with the written consent of the participating parties and ECCC.

4.4 This agreement may be amended with the written consent the participating companies and ECCC.

4.5 A participating company may end its participation in this agreement at any time, without cause and for their sole convenience, by providing at least 3 month’s written notice to ECCC of its intention to terminate. The agreement will then remain in effect for the remaining participating companies.

4.6 ECCC may terminate the agreement with all or some of the participating companies without cause and at its sole convenience by providing at least 3 month’s written notice of its intention to terminate.

4.7 In the event that a participating company no longer uses or releases chlorhexidine and its salts, it shall so inform ECCC, and that party’s responsibilities under this agreement shall end. However, the agreement will remain in effect for the remaining participating companies.  

4.8 ECCC may amend Annex A: list of participating companies to include a new participating company without the consent of existing participating companies. The agreement will become effective for the new participating company after ECCC and the new participating company sign Annex A.

5. Performance objectives

A participating company agrees to:

6. Retention of records

A participating company will keep copies of its chlorhexidine management plan and chlorhexidine evaluation reports for the duration of this agreement plus 1 year thereafter.

7. Reporting

7.1 A participating company will provide to ECCC the following documents:

7.2 The above documents will be sent to:

The Chemical Production Division
Environmental Protection Branch, Industrial Sectors and Chemicals Directorate
Environment and Climate Change Canada, Government of Canada
Email: pgpc-dppc-cmp-cpd@ec.gc.ca

7.3 ECCC will review a participating company’s chlorhexidine management plan and evaluation reports and prepare a draft annual summary of the progress and results. ECCC will provide a participating company with a copy of the draft annual summary of progress and results.

7.4 A participating company will review the ECCC summary of its progress and results and provide any comments they may have to ECCC within 30 days of receipt of the summary from ECCC.

7.5 ECCC will post the annual summary of progress and results of participating companies in the environmental performance agreements section of canada.ca.

8. Verification

8.1 ECCC will review and verify the documents submitted under subsection 7.1 and will assess progress made under this agreement on an annual basis. ECCC may request additional information from a participating company if necessary to conduct its review and verification.

8.2 ECCC will perform verifications of the content of the reports at the facilities of a participating company as set out in Annex D. These verifications will be conducted at least 2 times throughout the agreement that may include facility personnel interviews, site visits and verification of records.

8.3 A participating company will complete any agreed upon corrective actions identified by the verification team and confirm completion in writing and by providing supporting documentation to ECCC within the agreed timeline as described in the verification protocol set out in Annex D.

9. Roles and responsibilities

9.1 A participating company agrees to:

9.2 ECCC agrees to:

10. Acknowledgements and failure to implement

10.1 ECCC agrees to acknowledge publically the accomplishments of a participating company made pursuant to this agreement. The time and manner of any such acknowledgement will be at the discretion of ECCC.

10.2 Participating companies understand that when ECCC is assessing whether regulatory or other measures are required to prevent or reduce adverse impacts of releases of chlorhexidine moiety into the aquatic environment, it will consider whether the objectives and requirements of this agreement have been met.

11. Availability of agreement and confidential information

11.1 A copy of this agreement, and related information such as status reports, will be made available on Government of Canada’s website.

11.2 Correspondence with ECCC related to this agreement should be sent to ECCC by electronic mail at pgpc-dppc-cmp-cpd@ec.gc.ca.

11.3 ECCC agrees to keep confidential and not disclose any confidential information obtained from participating companies under this agreement as set out in section 321 of CEPA. A request for confidentiality from a participating company will specify the information that is considered to be confidential and the reason why it should be treated as such.

11.4 Nothing in this agreement shall be interpreted to preclude ECCC from disclosing information that ECCC may be required or ordered to disclose pursuant to any applicable federal laws or court orders, including, the Access to Information Act, R.S.C. 1985.

12. Signatures

By signing Annex A to this performance agreement, the parties acknowledge that they have read and accept all of the terms and provisions of the agreement.

ECCC may add other companies to this this agreement by accepting the signature of a duly authorized representative on Annex A: list of participating companies.

Annex A: List of participating companies

Agrisan Specialty Chemical and Pharmaceutical

Signature:

Name (Print):

Title:

Date:

Environment and Climate Change Canada

Signature:

John Moffet
Assistant Deputy Minister,
Environmental Protection Branch
Environment and Climate Change Canada

Date:

Germiphene Corporation

Signature:

Name (Print):

Title:

Date:

Environment and Climate Change Canada

Signature:

John Moffet
Assistant Deputy Minister,
Environmental Protection Branch
Environment and Climate Change Canada

Date:

Annex B: Chlorhexidine annual evaluation report

Complete and submit a copy of this report to pgpc-dppc-cmp-cpd@ec.gc.ca by March 30 for every year that this agreement is in effect plus 1 year after. In accordance with subsection 11.3 and 11.4, ECCC agrees not to disclose any confidential information obtained with this form.

1. Contact information

Name and civic address of the person providing information or duly authorized representative:

2. The facility’s estimated concentration of chlorhexidine moiety entering the aquatic environment.

Use the following procedure to estimate the facility’s concentration of chlorhexidine moiety in the aquatic environment.

Add rows as necessary to complete the evaluation report.

Step 1: calculate the total quantity of chlorhexidine moiety used per year (kg/yr)

Chlorhexidine moiety is the chlorhexidine molecule without the salt.  To convert the mass of chlorhexidine and its salts to the mass of the chlorhexidine moiety, the following conversion factors are used.

  • Chlorhexidine digluconate: 0.56
  • Chlorhexidine diacetate: 0.81
  • Chlorhexidine dihydrochloride: 0.87
Chlorhexidine moiety used ( kg / yr ) = ( 0.56 a + 0.81 b + 0.87 c )

Where;

  • a = quantity of chlorhexidine digluconate used per year (kg/yr)
  • b = quantity of chlorhexidine diacetate used per year (kg/yr)
  • c = quantity of chlorhexidine dihydrochloride used per year (kg/yr)
Evaluation Criteria Result/Comments
(a) kg of chlorhexidine digluconate  
(b) kg of chlorhexidine diacetate  
(c) kg of chlorhexidine dihydrochloride  
Total chlorhexidine moiety used (kg/year) = (0.56a + 0.81b + 0.87c)  

Step 2: estimate the average quantity of chlorhexidine moiety entering the aquatic environment (kg/day)

Average Quantity ( kg day ) = Chlorhexidine Moiety Used ( kg yr ) x Fraction lost to WW Release Days per year x [ 1 - ( WWTP EFF 100 ) ]

Where;

WWTPEFF = Wastewater Treatment Plant Removal Efficiency

AssumptionsFootnote 1  that may be used:

  • Fraction lost to Wastewater (WW) = 0.00426
  • WWTP EFF for Primary Treatment ~ 84%
  • WWTP EFF for Secondary Treatment ~ 98%
  • WWTP EFF for Lagoons ~ 94%
Evaluation criteria Result/comments

Fraction lost to wastewater

(If using an assumption that differs from the one provided in Step 2, please provide assumption and justification)

 
Number of release days/batches per year  
Wastewater treatment type

Wastewater Treatment Efficiency (%)

(If using an assumption that differs from the one provided in Step 2, please provide assumption and justification)

 
Estimated daily release of chlorhexidine moiety (kg/day)  

Step 3: estimate the facility’s concentration of chlorhexidine moiety in the aquatic environment (ng/L)

Concentration ( ng L ) = [ Average Quantity ( kg day ) WWTP Flow ( L day ) x ( 10 12 ng kg ) ] / DF

Where;

DF = Dilution factorFootnote 2  = 10
WWTP Flow = Wastewater treatment effluent flowFootnote 2  may be estimated as follows:

  • Arthur Wastewater Treatment Plant Effluent Flow ~ 1,733,000 L/day
  • Cainsville Lagoon Effluent Flow ~ 1,775,000 L/day
Evaluation Criteria Results/comments

Wastewater treatment effluent flow to the river (L/day)

(If using an assumption that differs from the one given in Step 3 please provide assumption and justification)

 
Estimated concentration of chlorhexidine moiety entering the aquatic environment (ng/L)  

Is the estimated concentration of chlorhexidine moiety entering the aquatic environment lower than the Predicted No Effect Concentration (PNEC) of 210 ng/L.

If no, please explain what best management practices will be implemented to reduce the contribution of chlorhexidine moiety from the facility:

3. Completion of the annual review of the chlorhexidine management plan as per subsection 5.2 of the Agreement:

4. Reporting on implementation of best management practices

Has the Facility implemented the recommended best management practices as described in Annex C?

1. Implementation of an environmental management system (EMS)

Please describe:

2. Training on operational procedures

Please describe:

3. Written procedures of best practices for receiving, storing and transfer of chemical substances and their packaging.

Please describe:

4. Batch Process Operations

Please describe:

5. Written procedures of best practices for packaging, loading, shipping and handling chemical substances and their packaging.

Please describe:

6. A waste management plan that includes waste minimization, re-use, recycling, storage and disposal procedures.

Please describe:

7. Maintenance operations for pollution control, safety and other critical equipment.

Please describe:

8. Spills and leak procedures.

Please describe:

9. Other

Please describe:

5. Sampling and analysis as per subsection 5.3 of the agreement.  

Was sampling conducted twice within the reporting year?

If no, please explain:

1. Date and concentration range (lowest to highest) for first batch of samples (ng/L)  
2. Date and concentration range (lowest to highest) for second batch of samples (ng/L)  

Were samples taken at the final discharge point of the facility and representative of the highest expected concentration of chlorhexidine moiety resulting from normal operating conditions?

Please explain:

Were samples analyzed by an accredited laboratory as described in subsection 5.3 of the agreement?

If no, please explain (describe the method used and provide the method detection limit, accuracy and precision of the method):

Annex C: Best management practices

The following best management practices should be considered in preparing the chlorhexidine management plan.

1. Environmental management system (EMS)

A participating company should develop, implement and maintain an EMS consisting of a set of policies and procedures for the responsible management of chemical substances using the best management practices below. The EMS should be consistent with nationally recognized EMS standards (for example, ISO14001) and an annual or more frequent review of the EMS should be conducted to identify and implement EMS improvement.

2. Training on operational procedures

Training on environmental policy and procedures, including clear definitions of roles and responsibilities with respect to environmental management work.

The training program should ensure that all management, employees and contractors are familiar with the EMS and associated best practices. Training could also be extended to customers.

Training should cover task-specific (for example, equipment cleaning) and facility-wide activities (for example, chemical storage, spill response) while providing employees with context regarding the importance of them following procedures.

3. Written procedures of best practices for receiving, storing and transfer of chemical substances and their packaging

Reception of chemicals:

Storage of chemicals:

Transfer of chemical substances:

Chemical substances transferred from storage containers into processing vessels for production operations can result in unintended releases. There is often precise handling guidelines outlined for specific substances or substance groups, and the facility operators should be cognizant of which practices should be applied within their facilities. Regardless of the type of container utilized, all employees and contractors involved in the transferring of chemicals should be fully trained to understand the contents of containers and the prevention of spills.

Some best practices for transferring chemicals may include the following activities:

4. Batch process operations

Products containing chlorhexidine are generally prepared in batches using a tank where pure chlorhexidine salt is diluted and mixed with other substances. These batch processes involve equipment cleaning/rinsing between batches to avoid cross contamination. This cleaning/rinsing process can result in releases of chlorhexidine moiety to the aquatic environment. All efforts should be made to minimize release of chemicals in the environment from batch process rinsing.

Best practices include the following activities:

5. Written procedures of best practices for packaging, loading, shipping and handling chemical substances and their packaging

A participating company should engage with transportation partners and logistics service providers to ensure that it has properly implemented chemical spill prevention procedures, as losses can occur at transport interfaces (loading, unloading, and handling) during transport from the distributor to end-user.

Best practices include the following activities:

6. A waste management plan that includes waste minimization, re-use, recycling, storage and disposal procedures

A participating company should develop and implement a waste management plan covering all aspects of waste management at its facilities. This waste management plan should address opportunities for recycling/reuse of waste materials as well as the disposal of waste materials.

Best practices include the following activities:

7. Maintenance operations for pollution control, safety and other critical equipment

In regards to maintenance of equipment, an effective maintenance program should be in place.

Best practices include the following activities:

8. Spills and leak procedures

In the event of a spill of chlorhexidine and its salts, the participating company should immediately take all necessary measures to contain and prevent releases into the environment.

Best practices include the following activities:

Annex D: Verification protocol for the environmental performance agreement concerning the formulation of chlorhexidine products

The following verification protocols were developed to ensure participating companies are meeting the objectives and requirements of the agreement.

1.0  Verification scope and objective

This protocol establishes verification procedures for the second party verification of the requirements of the environmental performance agreement concerning the formulation of chlorhexidine products (the agreement) between Environment and Climate Change Canada (ECCC) and a participating company.  

The objective of the verification is to confirm that the agreement is being fully implemented by a participating company in order to reduce the total concentration of chlorhexidine moiety released from industrial facilities that formulate chlorhexidine-based products.

2.0 Definitions and abbreviations

Agreement

The Environmental performance agreement concerning the formulation of chlorhexidine products.

Chlorhexidine moiety

The chlorhexidine molecule without the salt. Chlorhexidine salts dissociate (split apart) in water, releasing the chlorhexidine moiety.

Facility

An industrial facility using chlorhexidine and its salts to formulate chlorhexidine-based products.

Participating company

A company that is a party to this agreement that owns 1 or more facilities using chlorhexidine and its salts to formulate chlorhexidine-based products.

Verification

A second party verification process to review, assess and confirm the information and claims made by a participating company under this agreement. Verification will include a documentation review, site visit and follow-up activities.

3.0 Verifiable information

The following information will be kept on site at a facility or on file by a participating company in order to demonstrate that the objectives of the agreement have been met:

4.0 Verifier qualifications

The verification team will be made up of officials from ECCC who:

5.0 Roles and responsibilities

This section outlines the roles and responsibilities for participating companies and ECCC.

Participating companies

In addition to meeting the requirements outlined in the agreement, a participating company agrees to second party verifications of the agreement requirements.

Each participating company will:

Environment and Climate Change Canada

The ECCC verification team will:

6.0 Verification process

Each participating company agrees to the following verification steps.

6.1 Pre-verification

When it is determined that a participating company will be verified via a site visit, a mutually agreed site visit date that provides the participating company with at least 3 months’ notice will be identified. Two months prior to the verification, a conference call will be held to allow the participating company’s staff to ask the verification team questions and to inform the verification team which of the participating company’s staff will be present for the verification. At this time, the logistics of the verification will be confirmed.

The ECCC verification team will review reported data and information previously provided in the chlorhexidine management plan and chlorhexidine evaluation reports to ascertain completeness and consistency of these documents over time.

The ECCC verification team will prepare a verification plan and submit it to the participating company in advance of the site visit. The participating company will provide any necessary background documentation, such as procedures and records, prior to the commencement of verification activities.

6.2 Verification execution

Activities conducted by the ECCC verification team may include:

The ECCC verification team will identify areas where they are of the opinion that the agreement has not been fully implemented, provide recommendations, if any, on where the participating company should focus its attention in the future, and may suggest opportunities for continuous improvement. The verifiers will take into account that the agreement provides flexibility for facilities to apply measures that are most appropriate to their operations. The verifiers will make reference to specific sections of the agreement when presenting their preliminary findings to the staff that participated in the verification process, in order to show how the findings are linked to the overall objectives of the agreement.

6.3 Post-verification

The outcome of the verification will be communicated to the participating company through a draft, written report prepared by the verification team. The draft verification report will contain, at a minimum:

Within 4 weeks of the verification, the lead verifier will provide a draft, written report to the participating company representative for internal distribution, review and comment. Within 4 weeks of its receipt of the draft report, the participating company will provide any comments to the verification team, propose corrective actions to remedy any areas of incomplete implementation and suggest a timeline to complete the corrective actions. During its review of the report, the participating company should also identify any information that it would request be treated as confidential as per subsection 11.3 of the agreement. The participating company should also inform the verification team of corrective actions taken since the verification, so that these can be noted in the final verification report.

The lead verifier will review the comments received from the participating company and modify the verification report as appropriate. If a consensus cannot be reached on the list of corrective actions or timelines for completing them, the participating company will outline its concerns in a letter that will be attached to the verification team’s final verification report.

The final report, including the agreed list of areas of incomplete implementation and a timeline for corrective actions, will be submitted to the participating company representative within 16 weeks of the onsite verification.

ECCC will post a summary of the results of the annual verification publicly in the environmental performance agreements section of canada.ca.

7.0 Follow-up mechanisms

Within the agreed timeline, the participating company will complete the corrective actions identified in the final verification report and confirm this completion in writing, supported by documentation, to ECCC.

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