Proposed Registration Decision PRD2013-02, Ammonia (Present as Ammonium Sulfate)

Notice to the reader: The online consultation is now closed. Comments and suggestions received during the public consultation period are being considered in the finalization of this document. The final report will be made available as soon as possible.

Pest Management Regulatory Agency
15 March 2013
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2013-2E-PDF (PDF version)

Summary

Table of Contents

• Proposed Registration Decision for Ammonia present as Ammonium Sulfate
• What Does Health Canada Consider When Making a Registration Decision?
• What Is Ammonia (present as Ammonium Sulfate)?
• Health Considerations
• Environmental Considerations
• Value Considerations
• Measures to Minimize Risk
• Next Steps
• Other Information

Proposed Registration Decision for Ammonia present as Ammonium Sulfate

Health Canada's Pest Management Regulatory Agency (PMRA), under the authority of the Pest Control Products Act and Regulations, is proposing full registration for the sale and use of the technical product Fennosurf 583-T and the end-use product Fennosurf 583-C, containing the technical grade active ingredient ammonia (present as ammonium sulfate), to control bacteria and fungi in pulp and paper mills.

An evaluation of available scientific information found that, under the approved conditions of use, the product has value and does not present an unacceptable risk to human health or the environment.

This summary describes the key points of the evaluation, while the Science Evaluation of Proposed Registration Decision PRD2013-02, Ammonia (Present as Ammonium Sulfate) provides detailed technical information on the human health, environmental and value assessments of Fennosurf 583-T and Fennosurf 583-C.

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 (for example, those most sensitive to environmental contaminants). 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:

• Protecting Your Health and the Environment
• Pesticide Registration Process
• Pesticide Risk Reduction Program

Before making a final registration decision on ammonia (present as ammonium sulfate), the PMRA will consider all comments received from the public in response to Proposed Registration Decision PRD2013-02, Ammonia (Present as Ammonium Sulfate). The PMRA will then publish a Registration Decision on ammonia present as ammonium sulfate, 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 Proposed Registration Decision PRD2013-02, Ammonia (Present as Ammonium Sulfate).

What Is Ammonia (present as Ammonium Sulfate)?

Ammonia (present as ammonium sulfate) is the active ingredient in the end-use product Fennosurf 583-C which is proposed to control bacteria and fungi in pulp and paper mills.

Ammonium sulfate provides a source of ammonia (NH3). The active ingredient of the Fennosurf 583-C treatment is monochloramine (NH2Cl), which is being generated in situ when the ammonia from the ammonium sulfate reacts with the sodium hypochlorite. This reaction occurs through a dispensing device mixing sodium hypochlorite and Fennosurf 583-C. Monochloramine is known to kill cells by destroying and/or impairing cell walls as well as inhibiting proteins.

Health Considerations

Can Approved Uses of Ammonia (present as Ammonium Sulfate) Affect Human Health?

Ammonia (present as Ammonium Sulfate) is unlikely to affect human health when it is used according to label directions.

Exposure to ammonia (present as ammonium sulfate) may occur when handling the end-use product, Fennosurf 583-C (7.73% ammonia present as ammonium sulfate), which has a proposed commercial use as an antimicrobial product intended for pulp and paper mills. 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). Only uses for which the exposure is well below levels that cause no effects in animal testing are considered acceptable for registration.

The technical grade active ingredient, Fennosurf 583-T (25.5 % ammonia present as ammonium sulfate), is considered to be of low acute toxicity via the oral, dermal and inhalation routes of exposure. It is slightly irritating to eyes and skin, and is not expected to be a dermal sensitizer. Precautionary statements alerting users to the potential for eye and skin irritation are required on both the technical grade active ingredient and end-use product labels.

Dermal or inhalation exposure is possible for workers performing loading, clean-up and repair activities involving the end-use product, Fennosurf 583-C, and for workers engaged in postapplication activities such as coupling or uncoupling transfer lines. Accidental exposure to the eyes may occur if the product is splashed during handling. Therefore, precautionary measures including personal protective equipment are required on the end-use product label to mitigate such exposure concerns. The potential for bystander exposure is expected to be minimal as non-workers are not expected to be present in the wastewater treatment plant, and the end-use product is to be used in a closed system.

Residues in Water and Food

The proposed use of Fennosurf 583-C is for treatment of process waters in the production of non-food contact paper. Dietary intake is not anticipated.

No risk due to exposure from drinking water is anticipated.

Occupational Risks From Handling Fennosurf 583-C

Occupational risks are not of concern when Fennosurf 583-C is used according to label directions, which include protective measures.

Occupational exposure to individuals handling Fennosurf 583-C is not expected to result in unacceptable risk when the product is used according to label directions.

Precautionary (for example, wearing of personal protective equipment) and hygiene statements on the label aimed at mitigating exposure are considered adequate to protect individuals from any unnecessary risk due to occupational exposure.

Environmental Considerations

What Happens When Ammonia (present as Ammonium Sulfate) Is Introduced Into the Environment?

Ammonia (present as ammonium sulfate) is to be used in pulp and paper mills process water systems for the control of bacteria and fungi. The product is applied in conjunction with sodium hypochlorite to form monochloramine, a slow-acting oxidizing microbicide. Monochloramine, which is the primary chemical of environmental concern with the use of Fennosurf 583-C, could potentially enter the environment through industrial effluent discharge. Discharges can be to both freshwater and marine water bodies, as industrial facilities where this product is to be used can be located near both types of aquatic environments. Due to biological degradation during effluent treatment processes, and through chemical activity within the treatment system, levels of monochloramine discharged to the environment through effluent are expected to be very low. However, the chemical is toxic to aquatic organisms, and label statements requiring dechlorination of effluent to undetectable concentrations will be required prior to discharge, where applicable.

Value Considerations

What Is the Value of Fennosurf 583-C?

Fennosurf 583-C is used for the control of bacteria and fungi growth in pulp and paper mills.

In pulp and paper mills, the microorganisms such as bacteria and fungi must be controlled. These organisms can produce biofilms (slimes) on process equipment. Biofilms can also produce hydrogen sulfide, which is corrosive to machinery. Sloughing off of the biofilms leads to defects in the final paper sheet and disruptions of the paper making process. This results in a lower efficiency in the paper making process. In addition, bacteria and fungi growth can lead to spoilage of pulp resulting in significant waste and economical losses. Fennosurf 583-C will provide a source of ammonia to be mixed with sodium hypochlorite to generate monochloramine. This new active ingredient provides an alternative for the treatment of free floating bacteria and fungi in fouled paper systems.

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 Fennosurf 583-C to address the potential risks identified in this assessment are as follows.

Key Risk-Reduction Measures

Human Health

The statements 'May irritate eyes and skin', 'Avoid contact with skin, eyes and clothing', 'Avoid breathing vapour or spray mist' are required on the secondary display panel of the technical grade active ingredient end-use product labels.

The personal protective equipment for all loading, cleanup and repair activities required on the end-use product label includes protective eyewear, coveralls or long pants and long sleeved shirt, chemical resistant gloves, socks and chemical resistant footwear.

Environment

Label statements necessitating dechlorination of effluent to non-detectable concentrations when monochloramine residuals (measured as total chlorine, Cl2) are detected prior to discharge are required.

A label statement indicating toxicity to aquatic organisms is required.

Next Steps

Before making a final registration decision on ammonia (present ammonium sulfate), the PMRA will consider all comments received from the public in response to Proposed Registration Decision PRD2013-02, Ammonia (Present as Ammonium Sulfate). The PMRA will accept written comments on this proposal up to 45 days from the date of publication of Proposed Registration Decision PRD2013-02, Ammonia (Present as Ammonium Sulfate). 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 Agency's response to these comments.

Other Information

When the PMRA makes its registration decision, it will publish a Registration Decision on ammonia (present as ammonium sulfate) (based on the Science Evaluation of Proposed Registration Decision PRD2013-02, Ammonia (Present as Ammonium Sulfate)). In addition, the test data referenced in this consultation document will be available for public inspection, upon application, in the PMRA's Reading Room (located in Ottawa).