Implementation of the interim per- and polyfluoroalkyl substances standard for municipal biosolids imported or sold in Canada as fertilizers

On this page

• Issue
• Purpose
• Proposed risk management approach
  • Interim standard
  • Implementation via certificate of analysis and attestation
• Compliance verification at import and through Inspection
• A protective risk management approach
• Additional information
  • Federal fertilizer program mandate
  • Regulations of biosolids as fertilizers
  • Other fertilizer safety standards
  • Analytical methods
  • Scope and product coverage
  • Perfluorooctane sulfonate as an indicator
  • Other actions taken by the Canadian government
• Providing feedback

Issue

Per- and polyfluoroalkyl substances (PFAS) are contaminants of concern due to their inherent persistence and potential for negative effects on human health and the environment. Due to their widespread use in products and industrial applications, their persistence and mobility, they can be found in our soil, air, water and in the waste stream, including municipal biosolids. To mitigate the risks of contamination, the CFIA is proposing to implement an interim standard to address PFAS contamination in municipal biosolids imported or sold as fertilizers. The CFIA's proposed action is part of a broader Government of Canada response intended to reduce human and environmental exposure to PFAS and PFAS-containing products from their point of manufacture to their disposal (product life cycle approach).

Purpose

The purpose of this consultation is to seek input from Canadians (including growers, farmers and the general public) on the implementation of the interim standard for PFAS in biosolids.

Proposed risk management approach

Interim standard

The CFIA is proposing to adopt a standard of less than 50 parts per billion (ppb) of perfluorooctane sulfonate (PFOS; as an indicator of PFAS contamination) in domestic and imported biosolids represented as commercial fertilizers.

To import or sell biosolids in Canada as fertilizer, proponents will need:

• a certificate of analysis (CoA) for PFOS as an indicator (dated within the previous 6 months), and
• an attestation from the responsible party (importer, manufacturer, or seller) that the certificate is valid

Implementation via certificate of analysis and attestation

A CoA will be required from a laboratory accredited for US EPA method 1633 for biosolids. This is an interim measure that will change as more validated methodologies become available and laboratories obtain their accreditation. This document will need to show that the biosolids sampled had a concentration of PFOS below 50 ppb (based on dry weight). Testing will need to be performed at least every 6 months to account for any potential variation in inputs and treatment that may occur over the course of the year. The CoA provided at the time of import or domestic inspection will need to have a sampling date within the previous 6 months. The CFIA will provide a list of accredited laboratories to regulated parties as guidance.

An attestation form (template provided by the CFIA) filled and signed by the responsible party will be required to accompany the CoA. This form will attest to the validity of the CoA.

The requirement for a CoA and the attestation will be applicable to all biosolids products represented as fertilizers, including products that are exempt from registration that is, meet the definition of "municipal biosolids" as set out in the List of Primary Fertilizer and Supplement Materials as well as biosolids fertilizers that are not eligible for the exemption and therefore require registration.

Compliance verification at import and through inspection

To implement the standard for PFAS in biosolids, the requirement for CoA and attestation will be written into AIRS (Automated Import Reference System) system under HS Codes: 38.25.20 (Sewage sludge) and 38.25.10 (Municipal Waste). The documentation will need to be approved before the shipment is cleared for entry.

The Fertilizers Act offers a range of inspector powers that the Agency can use to administer and enforce the new proposed standard for PFAS in imported and domestic biosolids. Once the product is in the country, the CFIA inspectors will check the documentation (CoA and the attestation). Sales of domestically generated biosolids will be subject to the same compliance verification check to ensure level playing field and equitable treatment.

As with any CFIA inspections, their frequency will be based on compliance history and risk (potential for non-compliance). Additionally, industry standards and accreditation programs may also inform the design and delivery of inspections.

A protective risk management approach

To determine the most appropriate risk management approach, the CFIA:

• conducted a scientific literature review of PFAS with particular focus on risks to agriculture
• reviewed current and past assessments conducted by other regulatory departments and jurisdictions including Environment and Climate Change Canada, Health Canada, U.S. Environmental Protection Agency, the European Chemical Agency and the European Environmental Agency
• gathered available information on the levels of PFAS in soils and other matrices

The CFIA also considered potential impacts of a regulatory limit on the sector and waste diversion efforts across Canada. To that effect, we reviewed the beneficial uses of biosolids and data on levels of PFAS in biosolids collected by Environment and Climate Change Canada, and results of analysis from private companies voluntarily submitted to the CFIA. Analysis of this data revealed that the vast majority of domestic biosolids (92%) had PFOS (used as an indicator) concentrations below 50 ppb.

We further considered approaches and regulatory controls used by other departments and jurisdictions domestically and internationally. Based on this comparative review, we concluded that the approach implemented by the Michigan Department of Environment, Great Lakes, and Energy in March 2021 was a balanced, feasible and targeted approach. Michigan's interim strategy has been in place for 3 years and has shown great success, with significant reductions in PFAS contamination levels in tested biosolids. This approach focused on areas of highest risk while offering an adequate level of protection against heavily contaminated materials being applied to agricultural land in Canada as fertilizers.

The CFIA will continue to work with federal and provincial partners and stakeholders to monitor the evolving science on PFAS chemicals, various actions taken in other areas and monitoring contamination levels in biosolids and will review this interim approach in a years' time.

Additional information

Federal Fertilizer program mandate

Mitigating risks to Canada's plant and animal resource base is essential to a safe and accessible food supply, robust public health system, and sustainable environment. The Fertilizer program's mandate is to ensure that fertilizers and supplements imported into or sold in Canada are safe and properly labelled. Protection of human health is a key component of this mandate and it includes both direct exposure considerations (workers and by-standers) as well as indirect impacts associated with food and animal feed contamination, impacts on soil health, and environmental safety. The Fertilizers Act explicitly prohibits the manufacture, sale, import or export of any fertilizer or supplement that presents a risk of harm to human, animal, or plant health or the environment.

Regulation of biosolids as fertilizers

Biosolids, when imported or sold in Canada, are regulated as fertilizers but are exempt from pre-market assessment and registration if they meet the "term" and the "definition" (compositional criteria) specified on the List of Primary Fertilizer and Supplement Materials:

Municipal biosolids (Specify grade): Solid, semi-solid or liquid material comprised of septage or municipal sewage sludge, or both, freed from grit and coarse solids, which have been subjected to physical, chemical or biological treatment, or a combination of these treatments, sufficient to mitigate against the presence and effect of generally detrimental or serious injurious substances that may be associated with untreated forms of this material (Biosolides municipaux)

Other forms of processed waste or sewage represented as fertilizers or supplements, that do not meet the above definition of municipal biosolids require registration prior to import or sale in Canada.

Other fertilizer safety standards

Under the safety provisions stipulated in the regulations, the CFIA administers and enforces safety standards for contaminants of concern including pathogens (fecal coliforms and Salmonella), trace metals, dioxins and furans (PCDD/Fs), and pesticide residues. This is not an exhaustive list of potential contaminants of concern found in fertilizer products but rather an "indicator" of the product's contamination profile and the effectiveness of the treatment process (most relevant in cases of waste-derived materials). There are currently no standards for PFAS in fertilizer in Canada or internationally.

Analytical testing methods

Currently the only method accredited for the biosolids matrix is the US EPA method 1633 (3rd draft) – Analysis of Per- and Polyfluoroalkyl Substances (PFAS) in Aqueous, Solid, Biosolids, and Tissue Samples by LC-MS/MS. A number of domestic and foreign laboratories (in the government, the private sector and academia) are working on validating additional methods for a wider range of PFAS analytes. As these become available, it is anticipated that more laboratories will seek accreditation to meet the growing testing demand ultimately lowering the price for each test.

The CFIA does not currently have the capacity to test for PFAS in biosolids but is in the process of validating an in-house method for biosolids. Once completed, analyses can be performed by CFIA labs for routine marketplace monitoring inspections, to confirm product compliance.

Scope and product coverage

The current approach is applicable only to municipal biosolids and does not include products that contain or are made from biosolids inputs such as composts, anaerobic digestates, ash from incinerated biosolids and pulp and paper sludges. The PFAS profile of these other materials has not been well-characterized (especially in Canadian context) and thus it would be premature to implement an interim standard without supporting empirical data. As more Canadian data on the levels of PFAS in these products become available the scope and product coverage of the standard can be adjusted accordingly.

PFOS as an indicator

While there are 4,700+ known PFAS chemicals, PFOS is one of the best understood chemicals of the class. PFOS is readily detectable in municipal biosolids by an accredited analytical method (U.S. Environmental Protection Agency 1633). The utility of PFOS as an indicator is demonstrated by Michigan's interim strategy which has shown reductions in PFAS contamination levels in tested biosolids over the 3 years since implementing their approach.

Other actions taken by the Government of Canada

On May 20th, 2023 Environment and Climate Change Canada and Health Canada published their draft state of per- and polyfluoroalkyl substances report and risk management scope for per- and polyfluoroalkyl substances. Once they review and analyze the feedback collected, they will release the final report and risk management options. Further federal actions to address PFAS releases to the environment may be proposed.

Other regulatory bodies either domestic or international are also implementing new risk mitigating measures which can change CFIA's current approach. Other factors that may also impact administration of the standard are industry compliance, voluntary standards, quality assurance programs or accreditation schemes employed by the sector.

Providing feedback

Following targeted consultations with provincial partners and impacted industry, the CFIA is now seeking feedback on the implementation of the proposed interim standard for PFAS in biosolids from Canadians (including the growers, farmers and the general public). It is critically important to the CFIA to gather perspectives on the proposed implementation of the interim standard before it comes into force. This will ensure its feasibility and assist the CFIA in identifying any potential current or future adjustments needed to the approach.

To provide feedback, consult Share your thoughts: Implementation of the interim standard on per- and polyfluoroalkyl substances in biosolids.