Proposed Registration Decision PRD2018-11, Tributyl Tetradecyl Phosphonium Chloride and Bellacide 350

This consultation is now closed.

Pest Management Regulatory Agency
24 July 2018
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2018-11E-PDF (PDF version)

This page is a summary of the consultation document. If you would like to comment, please request the full consultation document.

To obtain a full copy of Proposed Registration Decision PRD2018-11, Tributyl Tetradecyl Phosphonium Chloride and Bellacide 350 please contact our publications office.

Should you require further information please contact the Pest Management Information Service.

Summary

Proposed Registration Decision for Tributyl Tetradecyl Phosphonium Chloride

Health Canada's Pest Management Regulatory Agency (PMRA), under the authority of the Pest Control Products Act and Regulations, is proposing registration for the sale and use of Bellacide 350 Technical and Bellacide 350, containing the technical grade active ingredient tributyl tetradecyl phosphonium chloride (TTPC), to control microbial slime formation in enhanced oil recovery systems and fracturing fluid systems.

An evaluation of available scientific information found that, under the approved conditions of use, the health and environmental risks and the value of the pest control products is acceptable.

This summary describes the key points of the evaluation, while the Science Evaluation of Proposed Registration Decision PRD2018-11, Tributyl Tetradecyl Phosphonium Chloride and Bellacide 350 provides detailed technical information on the human health, environmental and value assessments of Bellacide 350 Technical and Bellacide 350.

What Does Health Canada Consider When Making a Registration Decision?

The key objective of the Pest Control Products Act is to prevent unacceptable risks to people and the environment from the use of pest control products. Health or environmental risk is considered acceptable if there is reasonable certainty that no harm to human health, future generations or the environment will result from use or exposure to the product under its proposed conditions of registration. The Act also requires that products have value when used according to the label directions. Conditions of registration may include special precautionary measures on the product label to further reduce risk.

To reach its decisions, the PMRA applies modern, rigorous risk-assessment methods and policies. These methods consider the unique characteristics of sensitive subpopulations in humans (for example, children) as well as organisms in the environment. These methods and policies also consider the nature of the effects observed and the uncertainties when predicting the impact of pesticides. For more information, please refer to the following:

Before making a final registration decision on tributyl tetradecyl phosphonium chloride and Bellacide 350, the PMRA will consider any comments received from the public in response to PRD2018-11. The PMRA will then publish a Registration Decision on tributyl tetradecyl phosphonium chloride and Bellacide 350, which will include the decision, the reasons for it, a summary of comments received on the proposed final registration decision and the PMRA's response to these comments.

For more details on the information presented in this summary, please refer to the Science Evaluation of PRD2018-11.

What Is Tributyl Tetradecyl Phosphonium Chloride?

Tributyl tetradecyl phosphonium chloride is an antimicrobial biocide that is effective at preventing microbial slime from forming in oilfield sites such as fracturing fluids and water flooding operations. Tributyl tetradecyl phosphonium chloride acts on cell membranes by making them more permeable and causing important cell components to leak out, ultimately leading to death of the bacteria.

Health Considerations

Can Approved Uses of Tributyl Tetradecyl Phosphonium Chloride Affect Human Health?

Bellacide 350, containing tributyl tetradecyl phosphonium chloride, is unlikely to affect your health when used according to label directions.

Potential exposure to tributyl tetradecyl phosphonium chloride may occur when handling and applying the end-use product, Bellacide 350, or when re-entering treatment sites to conduct clean-up and equipment maintenance. When assessing health risks, two key factors are considered:

  • the levels where no health effects occur and
  • the levels to which people may be exposed.

The dose levels used to assess risks are established to protect the most sensitive human population (for example, children and nursing mothers). As such, sex and gender are taken into account in the risk assessment. Only uses for which the exposure is well below levels that cause no effects in animal testing are considered acceptable for registration.

Toxicology studies in laboratory animals describe potential health effects from varying levels of exposure to a chemical and identify the dose level where no effects are observed. The health effects noted in animals occur at doses more than 100-times higher (and often much higher) than levels to which humans are normally exposed when pesticide products are used according to label directions.

In laboratory animals, both Bellacide 350 Technical, and the end-use product, Bellacide 350, were considered moderately toxic via the oral route and of low toxicity via the dermal route of exposure. They did not cause an allergic skin reaction. Bellacide 350 Technical and Bellacide 350 were considered highly acutely toxic via the inhalation route and corrosive to the eyes and skin. Consequently, the signal words and hazard statements "DANGER POISON" and "CORROSIVE TO EYES AND SKIN" are required on the labels of Bellacide 350 Technical and Bellacide 350.

In the available toxicology studies, there was no evidence to suggest that tributyl tetradecyl phosphonium chloride damaged genetic material. Health effects in animals given repeated oral doses of tributyl tetradecyl phosphonium chloride included clinical signs and reduced body weight. When tributyl tetradecyl phosphonium chloride was given to pregnant animals, effects on the developing fetus were observed at a dose level that also caused toxic effects in the mother, indicating that the young do not appear to be more sensitive to tributyl tetradecyl phosphonium chloride than the adult animal.

It was not possible to fully characterize the potential human health effects of tributyl tetradecyl phosphonium chloride due to the limited available toxicology database. However, exposure to tributyl tetradecyl phosphonium chloride in enhanced oil recovery systems and fracturing fluid systems was determined to be limited. For this reason, no additional toxicology studies were required for the current assessment.

Risks in Residential and Other Non-Occupational Environments

Risks from non-occupational exposure to Bellacide 350 are not expected.

Bystander exposure to Bellacide 350 is not expected to be greater than the exposure to mixer/loader/applicator or postapplication workers.

Occupational Risks From Handling Bellacide 350

Occupational risks are not of concern when Bellacide 350 is used according to the proposed label directions, which include protective measures.

Risks to individuals handling and re-entering areas containing Bellacide 350 are not of concern when the product is used according to label directions.

Applicators (mixing, loading and applying Bellacide 350) can come in direct contact with Bellacide 350 on the skin or through inhalation. Therefore the label will specify that Bellacide 350 must be applied using closed metred systems only (i.e., dry coupling) and anyone mixing, loading, or applying Bellacide 350 must wear coveralls worn over long-sleeved shirt and long pants, socks, chemical-resistant footwear, chemical resistant gloves, and protective eyewear (goggles or face mask).

There is potential for inhalation exposure to workers entering areas containing Bellacide 350. However, no risk of concern is expected for those workers when the product is used according to label directions.

Environmental Considerations

What Happens When Tributyl Tetradecyl Phosphonium Chloride Is Introduced Into the Environment?

Tributyl tetradecyl phosphonium chloride (TTPC) is used as a biocide to prevent and/or inhibit microbial growth and may be mixed with other biocides to increase their effectiveness. When used according to label directions as a biocide in fracturing fluids and well injection waters, tributyl tetradecyl phosphonium chloride does not pose a risk to the environment.

Tributyl tetradecyl phosphonium chloride can enter the environment when used in fracturing fluids, for waterflooding, or during disposal after the fluid has been used underground. Fracturing fluids are a chemical mixture used in oil and gas drilling operations to increase the quantity of hydrocarbons that can be extracted from reservoirs underground. Waterflooding (enhanced oil recovery) is a technical procedure where water and other chemicals, including biocides, are injected into the ground to displace residual oil. For post-use disposal, TTPC may be released unintentionally to soil or water after use as a fracturing fluid or in waterflooding if a waste disposal pipeline is damaged.

If TTPC reaches soil, it will bind to soil and initially resist breakdown by soil micro-organisms. As a result of this behaviour, TTPC is not expected to move downward through soil and reach groundwater. Due to its physical/chemical properties, if TTPC reaches water it will mix readily but is also expected to bind to sediment and other solid particles in water. After it binds to soil or sediment particles, it is expected to break down into several transformation products which may be released back into the overlying water. Because of its chemical properties, TTPC is not expected to be found in air or accumulate in organisms.

TTPC presents a negligible risk to birds and aquatic organisms. At high doses TTPC can be toxic to birds and aquatic organisms but due to its use pattern, the potential exposure of these organisms is expected to be minimal and, consequently, risk to these organisms is not of concern.

Value Considerations

What Is the Value of Bellacide 350?

Bellacide 350 controls microbial slime formation in oilfield operations such as fracturing and waterflooding.

Bellacide 350 provides effective control of microbial slimes in fracturing fluids and in the water used for enhanced oil recovery. It is compatible with current slime-management practices in oilfield operations. The availability of Bellacide 350 in Canada provides a new active ingredient with which to control bacteria that cause problematic biofilms and oil souring. It provides a valuable alternative biocide to an industry where a variety of biocides may be needed to address the microbial problems due to the inherent variation of the different oilfield sites.

Measures to Minimize Risk

Labels of registered pesticide products include specific instructions for use. Directions include risk-reduction measures to protect human and environmental health. These directions must be followed by law.

The key risk-reduction measures being proposed on the label of Bellacide 350 to address the potential risks identified in this assessment are as follows.

Key Risk-Reduction Measures

Human Health

  • To avoid direct contact with Bellacide 350 on the skin, the product must be applied using closed metered systems only (i.e., dry coupling). In addition, anyone handling (mixing, loading, or applying) Bellacide 350 must wear coveralls worn over long-sleeved shirt and long pants, socks, chemical-resistant footwear, chemical resistant gloves, and protective eyewear (goggles or face mask).

Environment

  • Environmental hazard statements for aquatic organisms are required.

Next Steps

Before making a final registration decision on tributyl tetradecyl phosphonium chloride and Bellacide 350, the PMRA will consider any comments received from the public in response to PRD2018-11. The PMRA will accept written comments on PRD2018-11 to 45 days from the date of publication of PRD2018-11. Please forward all comments to Publications. The PMRA will then publish a Registration Decision, which will include its decision, the reasons for it, a summary of comments received on the proposed final decision and the PMRA's response to these comments.

Other Information

When the PMRA makes its registration decision, it will publish a Registration Decision on tributyl tetradecyl phosphonium chloride and Bellacide 350 (based on the Science Evaluation of PRD2018-11). In addition, the test data referenced in PRD2018-11 will be available for public inspection, upon application, in the PMRA's Reading Room (located in Ottawa).

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