New substances: risk assessment summary 18253

Official title: Risk assessment summary for NSN 18253: Bacillus amyloliquefaciens strain J1, for use as a conditioner for treatment of natural and decorative ponds

Introduction

Under the Canadian Environmental Protection Act, 1999 (CEPA), animate products of biotechnology (i.e. “living organisms”) not listed on the Domestic Substances List (DSL) are considered “new” to Canada. Information and data prescribed by the New Substances Notification Regulations (Organisms) [NSNR(O)] must be submitted before manufacture or import takes place, and the assessment is conducted by Environment and Climate Change Canada (ECCC) and Health Canada (HC).  In other words, the Government of Canada must be notified before new living organisms are manufactured in or imported into Canada, and must assess their potential to harm human health and the environment.

Bacillus amyloliquefaciens (hereafter B. amyloliquefaciens) strain J1 was notified for manufacture for use as a conditioner for treatment of natural and decorative ponds. It was assessed according to the requirements for Schedule 1 of the NSNR(O), which applies to manufacture or import of new micro-organisms for introduction anywhere in Canada.

Regulatory decision

B. amyloliquefaciens strain J1 is considered not to be harmful to human health or the environment for the intended use as a conditioner in the treatment of natural and decorative ponds. In addition, B. amyloliquefaciens strain J1 is not anticipated to enter the environment in a quantity or under conditions that have or may have an immediate or long term harmful effect on the environment or its biological diversity, constitute or may constitute a danger to the environment on which life depends, or constitute or may constitute a danger in Canada to human life or health through this use.

After 18 May 2016, the manufacture or import of B. amyloliquefaciens strain J1 could proceed in Canada. This strain is eligible to be added to the Domestic Substances List, but, until such time that it is officially published in the Canada Gazette, it would still be considered a ‘new substance’ and subject to the NSNR(O).

Background

B. amyloliquefaciens strain J1 is a naturally-occurring bacterium that is intended for use as a conditioner in the treatment of natural and decorative ponds. The micro-organism is capable of producing enzymes that hydrolyze complex substrates (Mishra and Kumar 2012). As a result it can help reduce organic waste build-up resulting from accumulation of sludge and plant debris in ponds.

Hazard considerations

The environmental hazard potential of B. amyloliquefaciens strain J1 is considered to be low for the following reasons:

  • Strain J1 has been well identified as a strain of B. amyloliquefaciens and its characteristics are similar to those of other known strains of this species.
  • Considerable data is available on pathogenicity and toxicity of different strains of B. amyloliquefaciens. With the exception of some reversible effects seen in a few aquatic species when tested at very high concentrations, most studies did not show any adverse effects over a wide range of concentrations of the micro-organism. (reviewed in Environment Canada and Health Canada, 2015) .
  • There were no reports of adverse effects in the environment that can be attributed to B. amyloliquefaciens .
  • Regulatory authorities in Canada and internationally consider B. amyloliquefaciens to be harmless to the environment (PMRA, 2012; U.S. EPA, 2012; Environment Canada and Health Canada, 2015 and EFSA, 2016).

The human hazard potential of B. amyloliquefaciens strain J1 is considered to be low for the following reasons:

  • The biological properties and characteristics of strain J1 do not raise any human health concerns.
  • No reports of infection or food poisoning related to B. amyloliquefaciens strains have been reported in the literature.
  • Some strains of B. amyloliquefaciens can produce the toxin “amylosin” which has been shown  to have immunological and cytotoxic effects (Rasimus-Sahari et al., 2015). It is not known if strain J1 has the capacity to produce this toxin.   However, most literature reports associate effects from this toxin to strains of B. subtilis.
  • Data available from several pathogenicity and toxicity tests perfomed in animals using other strains of B. amyloliquefaciens indicated no adverse effects on the animal models tested (reviewed in Environment Canada and Health Canada, 2015).

Exposure considerations

The environmental exposure potential of B. amyloliquefaciens strain J1 resulting from its use as a conditioner in the treatment of natural and decorative ponds is considered to be medium for the following reasons:

  • Manufacturing of B. amyloliquefaciens strain J1 occurs under controlled conditions and the manufacturing process will not lead to significant environmental releases.
  • The use of B. amyloliquefaciens strain J1 in ponds and aquariums is not expected to lead to any significant increased environmental exposures beyond those expected for animal and plant species exposed to naturally occurring B. amyloliquefaciens inhabiting these enivronments.
  • Experiments conducted by the manufacturer indicate that the population of the introduced strain J1 in aquatic environments decreases over time.
  • In natural environments, it is expected that B. amyloliquefaciens strain J1 will not have a competitive advantage over other naturally occurring micro-organisms in soil or water.
  • Like other Bacillus species, B. amyloliquefaciens strain J1 is capable of forming endospores (a thick-walled resting spore). Therefore it has the potential to persist in the environment (Grossman and Losick, 1988; Kramer and Gilbert, 1989).
  • Other potential uses of B. amyloliquefaciens strain J1 include those reported for other strains of B. amyloliquefaciens. These include manufacture of biofilms and cleaning products as well as biological treatment of municipal wastewater. These potential uses could increase environmental exposure to strain J1.

The human exposure potential of B. amyloliquefaciens strain J1 is considered to be medium for the following reasons:

  • B. amyloliquefaciens strain J1 will be used as a conditioner in natural and decorative ponds, as well as in aquariums. It is estimated that each year approximately 1,000 to 2,000 Canadians may be exposed to strain J1 as a result of these applications, mostly through skin contact. When administered outdoors, wind dispersal may also lead to some inhalation exposure.
  • Other potential uses of strain J1, such as in the production of biofilms (to displace undesirable microorganisms) or use in a wastewater treatment system, is not expected to increase exposure above that expected for the proposed use.

Risk assessment conclusion

Risk is typically described as the probability of an adverse effect occurring based on hazards and a particular scenario of exposure (Environment Canada and Health Canada, 2011). Different exposure scenarios can be described based on intended and any potential uses. In the present case, the micro-organism will be used as a conditioner in the treatment of natural and decorative ponds or could be potentially used in biofilm production or in wastewater treatment systems.

Given the low potential environmental hazard, and medium environmental exposure from the use of B. amyloliquefaciens strain J1 as a conditioner for treatment of natural and decorative ponds, the environmental risk is considered low.

Given the low potential human health hazard the human health risk associated with medium human exposure from the use of B. amyloliquefaciens strain J1 as a conditioner for treatment of natural and decorative ponds is considered low.

Therefore, B. amyloliquefaciens strain J1 is not anticipated to enter the environment in a quantity or under conditions that have or may have an immediate or long term harmful effect on the environment or its biological diversity, constitute or may constitute a danger to the environment on which life depends, or constitute or may constitute a danger in Canada to human life or health.

Should the notified strain be approved and commercialized for use in biofilm production or be used in wastewater treatment systems, potential exposure to humans and/or the environment is not expected to change significantly, and would thus not significantly increase environmental or human health risks.

References

(excluding proprietary information or references provided by the notifier)

Environment Canada, Health Canada. 2015. Bacillus amyloliquefaciens 13563-0, Bacillus atrophaeus 18250-7, Bacillus licheniformis ATCC 12713, Bacillus subtilis ATCC 6051A (=ATCC 6051a), Bacillus subtilis ATCC 55405, Bacillus subtilis subspecies subtilis ATCC 6051, Bacillus subtilis subspecies inaquosorum ATCC 55406, Bacillus species 16970-5, Bacillus species 2 18118-1, Bacillus species 4 18121-4, Bacillus species 7 18129-3. [PDF]

EFSA. European Food Safety Authority. 2016. Peer review of the pesticide risk assessment of the active substance Bacillus amyloliquefaciens strain MBI 600.

Grossman AD and Losick R. 1988. Extracellular control of spore formation in Bacillus subtilis. Proceedings of the National Academy of Sciences USA. 85(12):4369-73.

Kramer JM and Gilbert RJ. 1989. In: Bacillus cereus and other bacillus species; foodborne bacterial pathogens. Doyle MP, editor. New York: Marcel Dekker Inc. Page 21.

Mishra VK, Kumar A. 2012. Plant Growth Promoting and Phytostimulatory Potential of Bacillus subtilis and Bacillus amyloliquefaciens. ARPN Journal of Agricultural and Biological Science. 7(7): 509-519.

PMRA-HC. 2012. Proposed decision decision PRD2012-32: Bacillus ubtilis var. amyloliquefaciens strain FZB24. Page 1.

Rasimus-Sahari S, Teplova VV, Andersson MA, Mikkola R, Kankkunen P, Matikainen S, Gahmberg CG, Andersson LC, Salkinoja-Salonen M. 2015. The peptide toxin amylosin of Bacillus amyloliquefaciens from moisture-damaged buildings is immunotoxic, induces potassium efflux from mammalian cells, and has antimicrobial activity. Applied and Environmental Microbiology. 81(8):2939-2949.

USEPA. 2012a. Bacillus subtilis var. amyloliquefaciens strain FZB24 (006480) biopesticide registration action document. United States Environmental Protection Agency.

USEPA. 2012b. Biopesticides registration action document on Bacillus subtilis var. amyloliquefaciens strain FBZ24. United States Environmental Protection Agency.

Environment Canada and Health Canada (2011), "Framework for Science-Based Risk Assessment of Micro-Organisms Regulated under the Canadian Environmental Protection Act, 1999".

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