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Department of Agriculture and Water ResourcesDesk-top assessment of international approaches to incorporating the Globally Harmonised System of Classification and Labelling of Chemicals in agricultural and veterinary chemicals regulation12 September 2016

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Tim KarlovDirector, Sustainable Agriculture Policy BranchDepartment of Agriculture and Water18 Marcus Clarke StreetCANBERRA ACT 2601

12 September 2016

Dear Tim

Desk-top assessment of international approaches to incorporating the Globally Harmonised System of Classification and Labelling of Chemicals in agricultural and veterinary chemicals regulation

Thank you for providing Deloitte Risk Advisory Pty Ltd (Deloitte) with the opportunity to assist the Department of Agriculture and Water Resources with research as to the GHS adoption and implementation in other international jurisdictions.

This report has been prepared for the Department of Agriculture and Water Resources and provides a summary of our research outcomes.

Yours sincerely,

Tony MorrisNational WHS PartnerSustainability ServicesDeloitte Risk Advisory Pty Ltd

Liability limited by a scheme approved under Professional Standards Legislation.Member of Deloitte Touche Tohmatsu Limited

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Desk-top assessment of international approaches to incorporating the Globally Harmonised System of Classification and Labelling of Chemicals in agricultural and veterinary chemicals regulation

Contents

1 Introduction 3

2 USA jurisdiction research outcomes 6

3 Canadian jurisdiction research outcomes 11

4 New Zealand jurisdiction research outcomes 15

5 Japanese jurisdiction research outcomes 18

6 Hazard vs. risk-based regulatory approaches for labelling 20

Inherent LimitationsThe Services provided are advisory in nature and have not been conducted in accordance with the standards issued by the Australian Auditing and Assurance Standards Board and consequently no opinions or conclusions under these standards are expressed. Because of the inherent limitations of any internal control structure, it is possible that errors or irregularities may occur and not be detected. The matters raised in this report are only those which came to our attention during the course of performing our procedures and are not necessarily a comprehensive statement of all the weaknesses that exist or improvements that might be made. Our work is performed on a sample basis; we cannot, in practice, examine every activity and procedure, nor can we be a substitute for management’s responsibility to maintain adequate controls over all levels of operations and their responsibility to prevent and detect irregularities, including fraud.Any projection of the evaluation of the control procedures to future periods is subject to the risk that the systems may become inadequate because of changes in conditions, or that the degree of compliance with them may deteriorate. Recommendations and suggestions for improvement should be assessed by management for their full commercial impact before they are implemented.We believe that the statements made in this report are accurate, but no warranty of completeness, accuracy, or reliability is given in relation to the statements and representations made by, and the information and documentation provided by the Department Agriculture and Water Resources personnel. We have not attempted to verify these sources independently unless otherwise noted within the report.Limitation of UseThis report is intended for the information and use of Department of Agriculture and Water Resources in accordance with our variation letter (dated 9 August 2016) to original order for services - Deed Reference No. 127074, Purchase Order No. 22951 dated 23 December, 2015. No other person or entity is entitled to rely, in any manner, or for any purpose, on this report. We do not accept or assume responsibility to anyone other than Department of Agriculture and Water Resources for our work, for this report, or for any reliance, which may be placed on this report by any party other than Department of Agriculture and Water Resources.Deloitte refers to one or more of Deloitte Touche Tohmatsu Limited, a UK private company limited by guarantee, and its network of member firms, each of which is a legally separate and independent entity (and in Australia this is the partnership of Deloitte Touche Tohmatsu).The entity named herein is a legally separate and independent entity. In providing this document, the author only acts in the named capacity and does not act in any other capacity. Nothing in this document, nor any related attachments or communications or services, have any capacity to bind any other entity under the ‘Deloitte’ network of member firms (including those operating in Australia).Liability limited by a scheme approved under Professional Standards Legislation.Member of Deloitte Touche Tohmatsu Limited© 2016 Deloitte Risk Advisory Pty Ltd.

This is a draft document. As it is a work in progress it may be incomplete, contain preliminary conclusions and may change. You must not rely on, disclose or refer to it in any document. We accept no duty of care or liability to you or any third party for any loss suffered in connection with the use of this document.

This is a draft document. As it is a work in progress it may be incomplete, contain preliminary conclusions and may change. You must not rely on, disclose or refer to it in any document. We accept no duty of care or liability to you or any third party for any loss suffered in connection with the use of this document.

This is a draft document. As it is a work in progress it may be incomplete, contain preliminary conclusions and may change. You must not rely on, disclose or refer to it in any document. We accept no duty of care or liability to you or any third party for any loss suffered in connection with the use of this document.

Hazard vs. risk-based regulatory approaches for labelling

1 IntroductionPurpose and scope of work1.1 The Department of Agriculture and Water Resources (the Department) required a ‘quick’, focussed

desk-top assessment of the labelling approaches of agricultural and veterinary chemicals in several international jurisdictions. The objective of the assessment was to identify the approaches to Globally Harmonised System of Classification and Labelling of Chemicals (GHS) labelling of agricultural and veterinary chemicals adopted in four nominated jurisdictions.

1.2 The cross-jurisdictional research included the United States of America (USA), Canada, New Zealand and Japan. These jurisdictions were selected on the expectation that they adopted risk-based regulatory arrangements for agricultural and veterinary (agvet) chemicals, analogous to the approach used in Australia.

1.3 Our desk-top research assessment attempted to:

a. Outline the approach to GHS labelling of agriculture and veterinary chemicals in each of the jurisdictions

b. Understand the rationale behind the adoption of the GHS for each of the in-scope jurisdictions

c. At a high-level, confirm whether those markets have well-developed regulatory arrangements in place for agricultural and veterinary chemicals and whether they adopt risk-based (as opposed to hazard-based) approaches to agricultural and veterinary chemical assessment and labelling

d. Identify the policy reasons for the approaches adopted if this information was publicly available.

1.4 The research assessment also considered whether the GHS envisages that competent authorities may implement risk-based labelling, where appropriate.

Work performed1.5 We performed the following activities:

a. Conducted research of publicly available information published by each jurisdiction’s regulator and other credible resource websites

b. Analysed the information on the websites and consolidated our research outcomes.

c. Included relevant information provided by the New Zealand regulator to the Department for the purpose of this report.

Summary of research1.6 The below provides a concise summary of our cross-jurisdictional research and is our interpretation

of the information obtained and examined. The summary should be read in conjunction with the detail in the various sections below.

Department of Agriculture and Water Resources Desk-top assessment of international approaches to incorporating the Globally Harmonised System of Classification and Labelling of Chemicals in agricultural and veterinary chemicals regulation 3

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This is a draft document. As it is a work in progress it may be incomplete, contain preliminary conclusions and may change. You must not rely on, disclose or refer to it in any document. We accept no duty of care or liability to you or any third party for any loss suffered in connection with the use of this document.

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Hazard vs. risk-based regulatory approaches for labelling

Jurisdiction Summary of research Section

USA a. The USA has adopted GHS for hazardous chemicals generallyb. Agricultural chemicals are required to undertake a hazard assessment

of the chemical and classification process so as to develop a safety data sheet (SDS) that is aligned with the requirements of the GHS

c. Agricultural chemicals are not required to display a label that aligns with the GHS. However, since 19921, US legislation considers all written, printed or graphic material accompanying a pesticide product to be part of the labelling and this includes the safety data sheet (SDS) which, since 2012, is required to be aligned to the GHS.

d. The US Environmental Protection Agency (EPA) noted that aligning the SDS with GHS increased the likelihood that information in the SDS may be inconsistent with that on the approved label. To reconcile label information approved by the EPA and the GHS information on the SDS, the EPA recommends that approved pesticide label content be incorporated into SDSs (in addition to the GHS content) with an explanation of why the two sets of information differ.

e. Veterinary chemicals and products are exempt from GHS labelling requirements; however, they are not exempt from providing a GHS compliant SDS.

f. USA has a risk-based labelling regulatory approach.

2

Canada a. Canada has adopted GHS for hazardous chemicals generally.b. The GHS implementation does not apply to agricultural chemicals

(pesticides are specifically excluded) in Canada. Other agricultural chemicals, that are not pesticides, may be captured under the Canadian Environmental Protection Act or the Hazardous Products Act (for workplace issues) if they meet the requirements and criteria of a defined hazard class or category. If so, GHS will then apply.

c. Veterinary medicines are regulated by Health Canada, the human medicines regulator. We found no evidence that GHS labelling applied to veterinary medicines.

d. Canada has a risk-based labelling regulatory approach.

3

New Zealand a. New Zealand has adopted GHS for hazardous chemicals generally.b. New Zealand provides a degree of flexibility to allow for both risk-

based and hazard-based labelling. There is no one rule for the labelling of agricultural chemicals in New Zealand. Instead, the New Zealand EPA has developed a Technical Guide (based on GHS) for the ‘Labelling of hazardous substances – hazard and precautionary information’, January 2012 which provides a procedure (guide) to be used to locate the signal word, pictograms, and hazard and precautionary statements required for any hazardous substance, some of which are likely to be agricultural chemicals.

c. Whilst the EPA consulted on the application of GHS pictograms, signal words, hazard and precautionary statements for agricultural chemicals in New Zealand, this has not been pursued and Deloitte did not find any evidence that this proposal has been implemented.

d. The inclusion of GHS statements on veterinary medicines labels is generally required unless companies apply risk-based labelling. In addition, New Zealand legislation recognises labels from Australia, the USA, Canada and other jurisdictions as meeting its labelling requirements for agvet chemicals.

e. New Zealand has an optional risk-based labelling regulatory approach.

4

1 https://www.epa.gov/sites/production/files/2014-04/documents/pr92-4.pdf

Department of Agriculture and Water Resources Desk-top assessment of international approaches to incorporating the Globally Harmonised System of Classification and Labelling of Chemicals in agricultural and veterinary chemicals regulation 4

This is a draft document. As it is a work in progress it may be incomplete, contain preliminary conclusions and may change. You must not rely on, disclose or refer to it in any document. We accept no duty of care or liability to you or any third party for any loss suffered in connection with the use of this document.

This is a draft document. As it is a work in progress it may be incomplete, contain preliminary conclusions and may change. You must not rely on, disclose or refer to it in any document. We accept no duty of care or liability to you or any third party for any loss suffered in connection with the use of this document.

This is a draft document. As it is a work in progress it may be incomplete, contain preliminary conclusions and may change. You must not rely on, disclose or refer to it in any document. We accept no duty of care or liability to you or any third party for any loss suffered in connection with the use of this document.

Hazard vs. risk-based regulatory approaches for labelling

Jurisdiction Summary of research Section

Japan a. Japan has implemented the GHS for hazardous chemicals generally.b. Japan has implemented GHS based on the classification of each

hazardous chemical. There is no general application of GHS labelling to agricultural chemicals in Japan.

c. Veterinary chemicals are regulated by the Pharmaceutical Affairs Act (Act No. 145 of 1960) in Japan. We found no evidence that GHS labelling applies to veterinary medicines.

d. Japan has a risk-based labelling regulatory approach.

5

1.7 We have also undertaken research into risk and hazard based labelling. The below is a concise summary of our research, with the detail included at Section 6:

a. The GHS does not impose binding treaty obligations on countries. It envisaged that competent authorities in many countries are implementing and maintaining risk-based labelling regulatory approaches, and will continue to do so.

b. The Food and Agriculture Organization of the United Nations and World Health Organisation (FAO/WHO) in their revised publication on ‘International Code of Conduct on Pesticide management – Guidelines on Good Labelling Practice for Pesticides, August 2015’ (the guidelines) advise that pesticides are included in the GHS although classification and labelling should follow national legislation where this is available. The guidelines recommend against mixing GHS and WHO classification for pesticide labelling for human health hazards.

c. While a major benefit of applying a GHS approach appears to be harmonisation of international trade, countries with well-developed risk-based agvet chemical regulatory systems will, in many cases, have existing unique labelling requirements (as is the case in Australia). As a result, few additional benefits for agricultural and veterinary chemicals are likely to arise from international harmonisation.

d. Veterinary medicines for the countries researched appeared commonly regulated similarly to human medicines and did not appear to be captured by GHS labelling requirements or, in the case of New Zealand, application of GHS labelling is not compulsory. This is consistent with the intention of the GHS itself, which states that ‘… the risks to subjects associated with the medical use of human and veterinary pharmaceuticals … are not part of this harmonization process (i.e. the GHS)’.

Department of Agriculture and Water Resources Desk-top assessment of international approaches to incorporating the Globally Harmonised System of Classification and Labelling of Chemicals in agricultural and veterinary chemicals regulation 5

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This is a draft document. As it is a work in progress it may be incomplete, contain preliminary conclusions and may change. You must not rely on, disclose or refer to it in any document. We accept no duty of care or liability to you or any third party for any loss suffered in connection with the use of this document.

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Hazard vs. risk-based regulatory approaches for labelling

2 USA jurisdiction research outcomesGHS implementation generally in the USA2.1 In the USA, there are a number of interested federal agencies that are affected by the adoption of

GHS, with differing scopes of regulation2:

Agency Scope of regulation Main relevant legislation

Department of Labour (DOL) - Occupational Safety & Health Administration (OSHA)

Workplace Occupational Safety and Health Standards, specifically the Hazard Communication Standard (HCS)

Environmental Protection Agency (EPA) - Office of Prevention, Pesticides and Toxic Substances

Pesticides Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)

Department of Transportation (DOT) – Pipeline and Hazardous Materials Safety Administration (PHMSA)

Transportation of dangerous goods

Hazardous Materials Regulations (Title 49 CFR Parts 100 -185)

Consumer Product Safety Commission (CPSC)

Consumer products Consumer Product Safety ActFederal Hazardous Substances Act

2.2 The USA officially adopted the GHS (3rd edition) on 26 March 2012 with the publication of the revised and GHS-aligned HCS. A four year transition period was initiated that enabled chemical suppliers, manufacturers, distributors and employers to alter processes to align with the newly updated requirements. During this transition period, there were four key transition dates3:

a. 1 December 2013, whereby employers were required to train employees on the new label elements and SDS format

b. The revised GHS became mandatory on 1 June 2015. Chemical manufacturers and distributors were then required to complete hazard reclassification processes and produce GHS labels (but not for agricultural and veterinary chemicals) and SDS. Distributors were permitted an additional six month grace period to ship old inventory, that was not GHS aligned

c. 1 December 2015 required distributors to fully comply with the new requirements (i.e. the six month grace period ended)

d. 1 June 2016 required organisations to update alternative workplace labelling and hazard communication programme, as necessary, and provide additional employee training for newly identified physical or health hazards.

2.3 OSHA served as the lead agency on the classification of chemicals and hazard communication. The DOT was the first agency to adopt the GHS.

2.4 OSHA's HCS is designed to protect against chemical-source injuries and illnesses by ensuring that employers and workers are provided with sufficient information to anticipate, recognise, evaluate, and control chemical hazards and take appropriate protective measures4. The intent is that this information is provided by means of SDSs, labels and employee training.

2.5 In accordance with the HCS, chemical manufacturers and importers are required to perform hazard classifications on the chemicals they produce or import5. Distributors and employers may also choose to conduct hazard classifications, if they are concerned about the adequacy of the hazard information received for the chemicals they use in their business.

2.6 Hazard determination (per the HCS) is6:

2 http://www.unece.org/trans/danger/publi/ghs/implementation_e.html#c25755 3 https://www.osha.gov/dsg/hazcom/effectivedates.html 4 https://www.osha.gov/dsg/hazcom/ghd053107.html

5 An employer that manufactures, processes, formulates, blends, mixes, repackages, or otherwise changes the composition of a hazardous chemical is considered a "chemical manufacturer".6 https://www.osha.gov/dsg/hazcom/ghd053107.html

Department of Agriculture and Water Resources Desk-top assessment of international approaches to incorporating the Globally Harmonised System of Classification and Labelling of Chemicals in agricultural and veterinary chemicals regulation 6

This is a draft document. As it is a work in progress it may be incomplete, contain preliminary conclusions and may change. You must not rely on, disclose or refer to it in any document. We accept no duty of care or liability to you or any third party for any loss suffered in connection with the use of this document.

This is a draft document. As it is a work in progress it may be incomplete, contain preliminary conclusions and may change. You must not rely on, disclose or refer to it in any document. We accept no duty of care or liability to you or any third party for any loss suffered in connection with the use of this document.

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Hazard vs. risk-based regulatory approaches for labelling

“…the process of evaluating available scientific evidence in order to determine if a chemical is hazardous pursuant to the HCS. This evaluation identifies both physical hazards (e.g., flammability or reactivity) and health hazards (e.g., carcinogenicity or sensitization). The hazard determination provides the basis for the hazard information that is provided in MSDSs, labels, and employee training. Hazard determination does not involve an estimation of risk.”

2.7 The procedures used in the hazard determination process must be described in writing and made available, upon request, to employees and their designated representatives, as well as to OSHA and National Institute for Occupational Safety and Health (NIOSH) officials.

2.8 The original standard (pre-GHS) was performance-based, allowing chemical manufacturers and importers to convey information on labels and material safety data sheets in whatever format they chose. Moving towards a GHS-aligned approach provided for a more standardised method for classifying hazards and conveying pertinent information to users.

2.9 The USA has implemented GHS based on the classification of each hazardous chemical. The HCS does not contain a list of chemicals pre-determined to be hazardous under the standard (except for chemicals OSHA has already determined to be carcinogens).

Agricultural chemical regulation system2.10 Chemicals and pesticides must be registered with the EPA. The process of registering a:

a. Pesticide with the EPA is a “scientific, legal and administrative” process7. The EPA undertakes a risk assessment process, including completing ecological, human health and cumulative risk assessments8

b. Chemical (which may include an agricultural chemical that is not a pesticide) with the EPA is required in accordance with its powers of the Toxic Substances Control Act9 (TSCA).

2.11 The FIFRA provides for federal regulation of pesticide distribution, sale, and use. Every pesticide sold or distributed in the USA must be registered by the EPA in accordance with the requirements of the FIFRA.

2.12 Before EPA may register a pesticide under FIFRA, the applicant must show, among other things, that using the pesticide according to specifications will not generally cause any unreasonable risk to humans or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide, or a human dietary risk from residues that result from a use of a pesticide in or on any food.10 FIFRA prohibits registration of pesticides that generally pose unreasonable risks to people, including agricultural workers, or the environment11.

2.13 In registering a pesticide, the EPA must determine that the pesticide’s labelling complies with the requirements of the FIFRA. Label requirements include, among other things, signal words, warning or precautionary statements and directions for use.

2.14 The EPA also regulates both the import and export of pesticides12. All pesticides that are intended to be used in the USA must be registered with EPA before import. All registered pesticides that are exported to other countries must bear the product label approved by EPA.

2.15 A combination product that contains a pesticide and a fertilizer is regulated as a pesticide product per the FIFRA. As such, it must be labelled in accordance with the FIFRA requirements for the whole product13.

GHS labelling approach for agricultural and veterinary chemicals2.16 The HCS, being a component of OSHA’s regulatory framework, does not require labelling for

certain chemicals, including pesticides. However, hazard classification is still required to inform the

7 https://www.epa.gov/pesticide-registration/about-pesticide-registration 8 https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/overview-risk-assessment-pesticide-program

9 The TSCA was passed by the United States Congress in 1976 and is administered by the EPA. It regulates the introduction of new or already existing chemicals.10 https://www.epa.gov/laws-regulations/summary-federal-insecticide-fungicide-and-rodenticide-act 11 https://www.epa.gov/enforcement/federal-insecticide-fungicide-and-rodenticide-act-fifra-and-federal-facilities 12 https://www.epa.gov/pesticides/international-activities-related-pesticides 13 https://www.epa.gov/pesticide-labels/pesticide-labeling-questions-answers#exemption

Department of Agriculture and Water Resources Desk-top assessment of international approaches to incorporating the Globally Harmonised System of Classification and Labelling of Chemicals in agricultural and veterinary chemicals regulation 7

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This is a draft document. As it is a work in progress it may be incomplete, contain preliminary conclusions and may change. You must not rely on, disclose or refer to it in any document. We accept no duty of care or liability to you or any third party for any loss suffered in connection with the use of this document.

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Hazard vs. risk-based regulatory approaches for labelling

development of the required SDS. Chemicals that fall outside OHSA’s labelling requirements include14:

“Any pesticide as such term is defined in the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.), when subject to the labelling requirements of that Act and labelling regulations issued under that Act by the Environmental Protection Agency”15

“Any chemical substance or mixture as such terms are defined in the Toxic Substances Control Act (15 U.S.C. 2601 et seq.), when subject to the labelling requirements of that Act and labelling regulations issued under that Act by the Environmental Protection Agency”16

“Any food, food additive, colour additive, drug, cosmetic, or medical or veterinary device or product, including materials intended for use as ingredients in such products (e.g. flavours and fragrances), as such terms are defined in the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or the Virus-Serum-Toxin Act of 1913 (21 U.S.C. 151 et seq.), and regulations issued under those Acts, when they are subject to the labelling requirements under those Acts by either the Food and Drug Administration or the Department of Agriculture”17

… “Agricultural or vegetable seed treated with pesticides and labeled in accordance with the Federal Seed Act (7 U.S.C. 1551 et seq.) and the labeling regulations issued under that Act by the Department of Agriculture”.

2.17 Consistent with the above provisions of the HCS, the EPA has not adopted the GHS labelling and product classification requirements for pesticides. The EPA’s website states that “in most cases, GHS hazard statements and pictograms should not appear on pesticide product labels sold and distributed in the United States”18.

2.18 However, OSHA requires Safety Data Sheets under its Hazard Communication Standard (29 CFR 1910.120019), which includes safety data sheets for pesticide products. The OSHA published a rule (77 Federal Register 17574-17896, March 26, 2012) to align its hazard communication standard and SDS requirements with the GHS20.

2.19 FIRFA section 2(p)(2)(A) defines labelling for pesticide products to include labels and all written, printed or graphic matter accompanying the pesticide at any time or to which reference is made on the label21. This definition, which includes SDSs when they accompany the corresponding pesticide, has been in place since at least 1992.

2.20 In 1992, the EPA issued notice 92-4 which confirmed that a material safety data sheet (MSDS) was considered pesticide labelling under the FIRFA definition when it accompanies a product and recognising the potential for conflict between the MSDS and pesticide label information,22. The notice indicated that MSDSs could legally accompany pesticide products without separate approval, on the condition that the information in the MSDS did not conflict with the approved label. If the information did conflict, the notice stated that this may be treated as a ‘misbranding’ violation under the FIFRA.

2.21 Prior to the adoption of the GHS, OSHA did not prescribe specific hazard statements, signal words or pictograms. The EPA recognises that the introduction of the GHS-aligned HCS has increased the potential for inconsistencies between approved FIFRA pesticide labelling content and that of the SDS. This arises because of differences in classification criteria between EPA labels and the GHS. Differences may also arise because some label elements, such as the hazard statements, signal

14 http://www.ecfr.gov/cgi-bin/text-idx?SID=5bd46c0f6dda76f8c82dbf2a7fbebc15&mc=true&node=se29.6.1910_11200&rgn=div8

15 Hazard Communication Standard (OSHA 3844-02 2016), pg.716 Hazard Communication Standard (OSHA 3844-02 2016), pg.817 Hazard Communication Standard (OSHA 3844-02 2016), pg.818 https://www.epa.gov/pesticide-labels/pesticide-labels-and-ghs-comparison-and-samples 19 http://www.ecfr.gov/cgi-bin/text-idx?

SID=5bd46c0f6dda76f8c82dbf2a7fbebc15&mc=true&node=se29.6.1910_11200&rgn=div8 20 https://www.epa.gov/pesticide-labels/pesticide-labels-and-ghs-comparison-and-samples 21 http://www.agriculture.senate.gov/imo/media/doc/FIFRA.pdf 22 https://www.epa.gov/sites/production/files/2014-04/documents/pr92-4.pdf

Department of Agriculture and Water Resources Desk-top assessment of international approaches to incorporating the Globally Harmonised System of Classification and Labelling of Chemicals in agricultural and veterinary chemicals regulation 8

This is a draft document. As it is a work in progress it may be incomplete, contain preliminary conclusions and may change. You must not rely on, disclose or refer to it in any document. We accept no duty of care or liability to you or any third party for any loss suffered in connection with the use of this document.

This is a draft document. As it is a work in progress it may be incomplete, contain preliminary conclusions and may change. You must not rely on, disclose or refer to it in any document. We accept no duty of care or liability to you or any third party for any loss suffered in connection with the use of this document.

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Hazard vs. risk-based regulatory approaches for labelling

words or pictograms, could differ for the same hazards. In 2012, EPA issued a pesticide registration notice (PRN 2012-1 for ‘Material Safety Data Sheets as Pesticide Labeling’)23, which states:

“There are differences between EPA’s current requirements and the GHS related to classification criteria, hazard statements, pictograms, and signal words. Therefore, EPA is issuing this clarification of its policy in order to avoid potential inconsistencies between EPA-approved labels for pesticides regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the SDSs that OSHA requires for these chemicals under the HCS.”

The notice goes on to state:

“OSHA’s HCS requires employers to have chemical hazard communication programs that include labeling, SDSs, and worker training. FIFRA labels approved by EPA pre-empt OSHA’s label requirements, but not the requirements for SDS and worker training (except for certified applicators and agricultural workers for whom EPA has training requirements).

In the past, there was minimal potential for inconsistency since OSHA did not prescribe specific hazard statements, signal words, or pictograms. OSHA has long required information on hazards that do not generally appear on pesticide labels (e.g., for chronic health effects), and this additional information is not inconsistent with the FIFRA label. However, SDSs that would comply with OSHA’s revised HCS/GHS requirements could be viewed as inconsistent with the FIFRA labeling since some of the label elements (e.g., pictogram(s), signal word(s), and/or hazard statement(s)) could differ for the same hazards

… EPA recognizes that conflicts between: FIFRA labels and SDSs for the same chemicals, … could mislead workers about hazards, in some instances perhaps creating the impression that pesticides are less hazardous when they are not. Confusion due to inconsistent labeling could result in increased risks to workers.”

2.22 The EPA issued notice 2012-1 to reconcile the GHS hazard information that is now required in OSHA safety data sheets with the hazard information required on pesticide product labels and to explain how registrants can ensure that SDSs do not conflict with EPA's label requirements:

“This PR Notice updates and clarifies EPA’s determination in PR Notice 92-4 that a Material Safety Data Sheet (MSDS) (also referred to as a Safety Data Sheet (SDS)) that accompanies a pesticide product is considered part of the pesticide’s labeling but may accompany a pesticide product without notification to or approval by the Agency, provided such labeling is consistent with the 40 CFR Part 156 labeling requirements( 24 ) .

(OSHA) requires SDSs under its Hazard Communication Standard (HCS) (29 CFR 1910.1200) and is moving to align its HCS requirements with the GHS ... EPA has not yet moved to amend its labeling regulations to reflect the GHS. There are differences between EPA’s current requirements and the GHS related to classification criteria, hazard statements, pictograms, and signal words. Therefore, EPA is issuing this clarification of its policy in order to avoid potential inconsistencies between EPA-approved labels for pesticides regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the SDSs that OSHA requires for these chemicals under the HCS ...

While EPA recognizes that this guidance may require users of the SDS prepared for pesticide products to become familiar with two different systems, at least until the agencies’ requirements are harmonized, it is necessary as an interim measure to ensure that the differences do not cause confusion and to provide regulated industry with a clear pathway to compliance with both agencies’ requirements.”

The notice clarifies that SDS information should not be considered inconsistent with the EPA approved pesticide label. In order to reconcile the two documents, the EPA recommends that SDSs incorporate relevant approved pesticide label content (in addition to the GHS content) and explain why the two sets of information differ:

“This PR Notice is intended to aid registrants in assuring that the SDSs for their products should not be considered inconsistent with the EPA-approved product labels by providing

23 https://www.epa.gov/sites/production/files/2014-04/documents/pr2012-1.pdf 24 http://www.ecfr.gov/cgi-bin/text-idx?SID=6c58b8a7870183f251b6e6b54b9f50b4&mc=true&node=pt40.26.156&rgn=div5

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This is a draft document. As it is a work in progress it may be incomplete, contain preliminary conclusions and may change. You must not rely on, disclose or refer to it in any document. We accept no duty of care or liability to you or any third party for any loss suffered in connection with the use of this document.

This is a draft document. As it is a work in progress it may be incomplete, contain preliminary conclusions and may change. You must not rely on, disclose or refer to it in any document. We accept no duty of care or liability to you or any third party for any loss suffered in connection with the use of this document.

This is a draft document. As it is a work in progress it may be incomplete, contain preliminary conclusions and may change. You must not rely on, disclose or refer to it in any document. We accept no duty of care or liability to you or any third party for any loss suffered in connection with the use of this document.

Hazard vs. risk-based regulatory approaches for labelling

guidance on how a registrant may reconcile an SDS with its associated FIFRA label, as stated below.

EPA believes that generally explaining why the FIFRA label and the SDS contain different hazard communication will prevent users from being misled by the inconsistencies. To provide an adequate explanation so the labeling is not misleading, EPA recommends registrants include in their SDSs the FIFRA label information and a brief explanation for any differences between that information and the SDS information.”

2.23 In relation to veterinary chemicals, OSHA’s response to standard interpretation (1910.1200) states that veterinary drugs that are subject to labeling requirements by the Food and Drug Administration (FDA) under the Federal Food, Drug and Cosmetic Act are exempt from the labeling provisions of OSHA's Hazard Communication Standard. However, this section of the HCS exempts only labelling requirements and does not exempt the other requirements of the standard such as providing Material Safety Data Sheets (MSDS). OSHA’s standard interpretation response states that25:

“The standard does not apply to nonhazardous drugs, but any drug that meets the criteria of a hazardous chemical in the HCS generally would be covered. The HCS contains some exemptions that would apply to some drug and veterinary products. Section (b)(5)(ii) of the HCS states that drugs that are subject to labelling requirements by the Food and Drug Administration (FDA) under the Federal Food, Drug and Cosmetic Act are exempt from the labelling provisions of OSHA's Hazard Communication Standard. Please note that this section of the HCS exempts only labelling requirements and does not exempt the other requirements of the standard such as providing Material Safety Data Sheets (MSDS).

Another section of the standard that is relevant to your situation is 1910.1200(b)(6)(viii) which exempts from coverage under the standard drugs as defined by the Federal Food, Drug and Cosmetic Act that are in solid final form, ready for direct administration to the patient such as tablets, capsules or pills. If these drugs are not in final form in that they are designed to be dissolved or crushed by employees prior to administration, then they are covered by the HCS.”

Rationale and policy reasons for the adopted labelling approach for agvet chemicals2.24 But for the SDS (aligned to the GHS) accompanying a pesticide label being considered as part of

the label, we found no published policy reasons as to why the EPA and OSHA have not adopted the GHS for labelling of agvet chemicals. However, we do note the EPA has a comprehensive and sophisticated risk-based registration and approval process for managing human health and other risks.

2.25 Veterinary medicines are regulated similarly to human medicines.

2.26 There is no indication in the sources examined as to whether the EPA or OSHA will adopt the GHS for package labelling in the future, although US EPA notice 2012-1 suggests this is possible (in relation to pesticides).

2.27

25 https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=INTERPRETATIONS&p_id=21343

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This is a draft document. As it is a work in progress it may be incomplete, contain preliminary conclusions and may change. You must not rely on, disclose or refer to it in any document. We accept no duty of care or liability to you or any third party for any loss suffered in connection with the use of this document.

This is a draft document. As it is a work in progress it may be incomplete, contain preliminary conclusions and may change. You must not rely on, disclose or refer to it in any document. We accept no duty of care or liability to you or any third party for any loss suffered in connection with the use of this document.

This is a draft document. As it is a work in progress it may be incomplete, contain preliminary conclusions and may change. You must not rely on, disclose or refer to it in any document. We accept no duty of care or liability to you or any third party for any loss suffered in connection with the use of this document.

Hazard vs. risk-based regulatory approaches for labelling

3 Canadian jurisdiction research outcomesGHS implementation generally in Canada3.1 In Canada, there are a number of interested agencies that are affected by the adoption of GHS, with

differing scopes of regulation26:

Agency Scope of regulation Main relevant legislation

Department of Health: National Officer of Workplace Hazardous Materials Information System (WHMIS) - Product Safety Programme

Workplace Hazardous Products Regulations

Department of Health: Pest Management Regulatory Agency (PMRA)

Pesticides Pest Control Products Act and Regulations

Department of Health: Veterinary Drugs Directorate

Veterinary drugs Food and Drugs Act and Regulations

Department of Transport: Transport of Dangerous Goods Directorate

Transportation of dangerous goods

Transportation of Dangerous Goods Act, 1992 and Transportation of Dangerous Goods Regulations

Department of Health: Consumer Product Safety Bureau, Product Safety Programme

Consumer products Consumer Product Safety Act and associated Consumer Chemicals and Container Regulations, 2001

3.2 Health Canada is the government body responsible for making the required changes to the overall federal WHMIS-related laws. The Controlled Products Regulations first became law in 1988 through a series of complementary federal, provincial and territorial legislation and regulations (referred to as WHMIS 1988). Updates to implement the Hazardous Products Regulations, which align with the GHS (5th edition), are referred to as WHMIS 2015 were introduced on 11 February 2015.

3.3 A multi-year transition plan is currently in effect:

a. Until 31 May 2017, suppliers (manufacturers and importers) can use WHMIS 1988 or WHMIS 2015 to classify and communicate the hazards of their products

b. From 1 June 2017 to 31 May 2018, distributors can continue to sell, and suppliers importing for their own use can continue to import, hazardous products with labels and SDS’ that are compliant with WHMIS 1988 or WHMIS 2015

c. From 1 June 2018, manufacturers and distributors are required to fully comply with WHMIS 2015

d. Employers had until 1 December 2015 to fully comply with WHMIS 2015.

3.4 If a product covered by the Hazardous Products Act meets the requirements and criteria of a defined hazard class or category, it is deemed to be a "hazardous product". Hazardous products that are used in the workplace must comply with the requirements of the WHMIS regulations, and a WHMIS programme, including education and training, must be implemented27.

3.5 Substances that are not on the Domestic Substances List (DSL) are considered to be new chemical substances in Canada. Any company or individual who plans to import or manufacture a new substance must provide Environment Canada with a New Substances Notification (NSN) dossier to import or manufacture as required by the Canadian Environmental Protection Act, 199928. Existing substances listed on the DSL are also subject to assessment.

26 http://www.unece.org/trans/danger/publi/ghs/implementation_e.html#c25755 27 http://www.ccohs.ca/oshanswers/chemicals/whmis_ghs/general.html 28 http://www.chemsafetypro.com/Topics/Canada/Canada_Environmental_Protection_Act_New_Chemical_Notification.html

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This is a draft document. As it is a work in progress it may be incomplete, contain preliminary conclusions and may change. You must not rely on, disclose or refer to it in any document. We accept no duty of care or liability to you or any third party for any loss suffered in connection with the use of this document.

This is a draft document. As it is a work in progress it may be incomplete, contain preliminary conclusions and may change. You must not rely on, disclose or refer to it in any document. We accept no duty of care or liability to you or any third party for any loss suffered in connection with the use of this document.

This is a draft document. As it is a work in progress it may be incomplete, contain preliminary conclusions and may change. You must not rely on, disclose or refer to it in any document. We accept no duty of care or liability to you or any third party for any loss suffered in connection with the use of this document.

Hazard vs. risk-based regulatory approaches for labelling

3.6 Health Canada and Environment Canada employ a screening level risk assessment process and appear to work in tandem to review and assess (for example) existing chemicals, depending on the nature of the hazard, per the below diagram29:

3.7 In Canada, ‘suppliers’ are those organisations who, in the course of business, sell or import hazardous products. Suppliers must ensure the appropriate classification of hazardous products as outlined in WHMIS 2015 (or WHMIS 1988 for the transition period).

3.8 Section 13 of the Hazardous Products Act 30 requires that a supplier who is selling a hazardous product that is intended for use, handling or storage in a work place in Canada is required to:

a. Provide a SDS to the purchaser

b. Ensure that the hazardous product or the container in which the hazardous product is packaged has a label that meets the requirements of the Hazardous Products Regulations.

3.9 Section 14 of the Hazardous Products Act 31 requires a supplier who is importing a hazardous product that is intended for use, handling or storage in a work place in Canada is required to:

a. Obtain or prepare a SDS

b. Ensure that the hazardous product or the container in which the hazardous product is packaged has a label that meets the requirements of the Hazardous Products Regulations.

3.10 Special rules for labelling in Canada32 include:

a. Small capacity containers (100 mL or less) - precautionary or hazard statements not required

b. Small capacity containers (3 mL or less) - labels not required during their use stage

29 A Guide to Understanding the Canadian Environmental Protection Act, 1999, pg.830 http://www.hc-sc.gc.ca/ewh-semt/occup-travail/whmis-simdut/faq-eng.php#s2m 31 http://www.hc-sc.gc.ca/ewh-semt/occup-travail/whmis-simdut/faq-eng.php#s2m 32 http://www.chemsafetypro.com/Topics/Canada/Canada_GHS.html

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This is a draft document. As it is a work in progress it may be incomplete, contain preliminary conclusions and may change. You must not rely on, disclose or refer to it in any document. We accept no duty of care or liability to you or any third party for any loss suffered in connection with the use of this document.

This is a draft document. As it is a work in progress it may be incomplete, contain preliminary conclusions and may change. You must not rely on, disclose or refer to it in any document. We accept no duty of care or liability to you or any third party for any loss suffered in connection with the use of this document.

This is a draft document. As it is a work in progress it may be incomplete, contain preliminary conclusions and may change. You must not rely on, disclose or refer to it in any document. We accept no duty of care or liability to you or any third party for any loss suffered in connection with the use of this document.

Hazard vs. risk-based regulatory approaches for labelling

c. Bulk shipment and unpackaged hazardous products - labels not required

d. In transit products or export-only - WHIMS labels and SDSs are not required.

3.11 Health Canada believed that, the implementation of the GHS:

“…will help strengthen worker health and safety in Canada, facilitate trade with the United States (U.S.), and enhance the competitiveness of Canadian suppliers of hazardous workplace chemicals. Adopting the GHS also fulfils the Canada-U.S. Regulatory Cooperation Council (RCC) commitment to align and synchronize implementation of common classification and labelling requirements for workplace hazardous chemicals”.33

3.12 Health Canada reported that a key objective of implementing the GHS was to create a system that allows Canadian and USA requirements to be met through the use of a single label and SDS for each hazardous product.

Agricultural chemical regulation system3.13 Pest control products, as defined in the Pest Control Products Act, are specifically excluded from

WHMIS 2015. Canadian pesticides are regulated by federal, provincial and municipal governments as follows:

a. The federal government evaluates and registers pesticides through the Pest Control Products Act and Regulations34, which are enforced by the Pest Management Regulatory Agency. All pesticides must be registered to be imported into, sold or used in Canada.

b. Under the authority of the Pest Control Products Act, Health Canada registers pesticides after a stringent, science-based evaluation that ensures any risks are acceptable 35

c. Provincial and municipal governments are responsible for the sale, use, storage, transportation and disposal of registered pesticides, as well as training, certification and licensing of applicators, vendors and growers within their province/territory. Provincial and municipal governments are also responsible for issuing permits, responding to spills and accidents and the classification of pesticides for sale and use within their province/territory.

3.14 Pest control products can be registered in Canada only if their use poses no unacceptable risks to human health or the environment and has value.36

3.15 Any company, agency, importer or person that wishes to sell a pesticide in Canada must submit detailed tests and studies that examine the potential risks posed to health and the environment and the product's value37.

3.16 Health Canada is then required to review the information provided in order to determine if the product is acceptable for use in Canada and will not harm humans and the environment. If the product is granted registration, the individual or group responsible for the submission becomes the product's registrant.

3.17 The sale and importation of fertilisers is regulated under the Fertilizers Act, which is administered by the Canadian Food Inspection Agency. However, if the fertiliser product meets any of the hazard criteria set out in the Hazardous Products Regulations, then it is deemed to be a "hazardous product"38.

GHS labelling approach for agricultural and veterinary chemicals3.18 As pesticides are excluded from the Hazardous Products Act, the labelling and SDS requirements

are detailed in the Pest Control Products Act, which appears to not have been updated to align with the requirements of the GHS.

3.19 Health Canada indicates that the label for pesticides must include information concerning the nature and degree of hazard inherent in the pest control product. The label:

33 http://www.hc-sc.gc.ca/ewh-semt/occup-travail/whmis-simdut/faq-eng.php#s1b 34 http://www.ccohs.ca/oshanswers/chemicals/pesticides/general.html 35 http://www.hc-sc.gc.ca/ahc-asc/branch-dirgen/pmra-arla/index-eng.php 36 http://www.hc-sc.gc.ca/cps-spc/pubs/pest/_pol-guide/dir2012-01/index-eng.php 37 http://www.hc-sc.gc.ca/cps-spc/pest/faq-eng.php#ass 38 http://www.hc-sc.gc.ca/ewh-semt/occup-travail/whmis-simdut/faq-eng.php#s2m

Department of Agriculture and Water Resources Desk-top assessment of international approaches to incorporating the Globally Harmonised System of Classification and Labelling of Chemicals in agricultural and veterinary chemicals regulation 13

This is a draft document. As it is a work in progress it may be incomplete, contain preliminary conclusions and may change. You must not rely on, disclose or refer to it in any document. We accept no duty of care or liability to you or any third party for any loss suffered in connection with the use of this document.

This is a draft document. As it is a work in progress it may be incomplete, contain preliminary conclusions and may change. You must not rely on, disclose or refer to it in any document. We accept no duty of care or liability to you or any third party for any loss suffered in connection with the use of this document.

This is a draft document. As it is a work in progress it may be incomplete, contain preliminary conclusions and may change. You must not rely on, disclose or refer to it in any document. We accept no duty of care or liability to you or any third party for any loss suffered in connection with the use of this document.

Hazard vs. risk-based regulatory approaches for labelling

a. Must identify the nature and degree of hazard by appropriate precautionary symbols (Poison, Corrosive, Flammable or Explosive39) and signal words together with a statement that indicates the nature of the primary hazard to which the symbol relates

b. A secondary panel must include information on significant risks associated with the use of the products and procedures to reduce those risks.

3.20 Whilst our research indicates GHS implementation does not apply to pesticides in Canada, other agricultural chemicals, that are not pesticides, may be captured under the Canadian Environmental Protection Act or the Hazardous Products Act (for workplace issues) if they meet the requirements and criteria of a defined hazard class or category. If so, GHS applies to those products.

3.21 Deloitte searched the Food and Drugs Act and Regulations40 in addition to guidance documents for veterinary chemicals. Whilst the legislation and guidance documents include instructions on labelling generally, there was nothing relating to GHS labelling for veterinary chemical labels.

Rationale and policy reasons for the adopted labelling approach for agvet chemicals3.22 There was no formal, published policy reasoning as to why the Pest Management Regulatory

Agency has not adopted the GHS. However, we do note a comprehensive and sophisticated risk-based approach was and is in operation for managing human health and other risks.

39 http://www.hc-sc.gc.ca/cps-spc/pubs/pest/_pol-guide/dir2012-01/index-eng.php 40 http://www.hc-sc.gc.ca/dhp-mps/vet/applic-demande/index-eng.php

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This is a draft document. As it is a work in progress it may be incomplete, contain preliminary conclusions and may change. You must not rely on, disclose or refer to it in any document. We accept no duty of care or liability to you or any third party for any loss suffered in connection with the use of this document.

This is a draft document. As it is a work in progress it may be incomplete, contain preliminary conclusions and may change. You must not rely on, disclose or refer to it in any document. We accept no duty of care or liability to you or any third party for any loss suffered in connection with the use of this document.

Hazard vs. risk-based regulatory approaches for labelling

4 New Zealand jurisdiction research outcomesGHS implementation generally in New Zealand4.1 The principal New Zealand legislation for hazardous chemicals is the Hazardous Substances and

New Organisms Act, 1996 (HSNO) and the regulations made under the Act41. This legislation imposes requirements for all phases of the life cycle of hazardous substances including the control of import, manufacture or use (including disposal) of manufactured chemicals that have hazardous properties. The hazardous properties (defined in accordance with the GHS criteria) are explosive, flammable, oxidizing, toxic, corrosive and ecotoxic.

4.2 HSNO controls apply at all stages in the manufacture, use and disposal of hazardous substances. Regulations cover packaging, disposal, tracking, qualifications of persons, emergency management and identification.

4.3 Generally, regulations made under the HSNO recognise compliance with the Land Transport Rule: Dangerous Goods 2005 (the Dangerous Goods Rule), which covers the packaging, identification and documentation of dangerous goods; the segregation of incompatible goods; transport procedures and the training and responsibilities of those involved in the transport of dangerous goods.

4.4 The Environmental Risk Management Authority (ERMA) New Zealand, in conjunction with the Ministry for the Environment, initiated work toward the revision of the hazardous substances classification framework under the HSNO and the Hazardous Substances (Classification) Regulations 2001, to bring it into line with the GHS. New Zealand consulted at the end of 2014 to update the hazard classification system required by the regulations, to reflect the GHS (5th edition, 2013) but the proposal stalled and has been deferred.

4.5 A chemical classification information database (CCID) containing chemicals classified by ERMA New Zealand in accordance with HSNO regulations (which are based on the GHS) is available42. The classification must be known before hazard and precautionary information requirements can be determined. Classifications are provided for physical hazards and biological hazards of a chemical. The HSNO hazard classification system is substantially equivalent to the GHS43.

4.6 The New Zealand Environmental Protection Authority (EPA) has developed a technical guide for the ‘Labelling of hazardous substances – hazard and precautionary information’, July 200644. This guide describes a procedure for manufacturers and suppliers to determine the pictograms, signal word, and hazard and precautionary statements required on the label of hazardous substances and are based on the GHS.

4.7 The EPA has also provided an information sheet on the correlation between GHS and the New Zealand HSNO hazard classes and categories45.

Agvet chemical regulation system4.8 The EPA’s role under the HSNO Act includes the regulation of pesticides and dangerous

substances that require controls be put in place to manage the risks of hazardous substances to safeguard people and the environment. Hazardous substances, including agrichemicals, need to be approved before they can be used in New Zealand.

4.9 With the creation of the new workplace safety regulator, WorkSafe New Zealand in 2013, it was recommended the regulation of the use of hazardous substances in the workplace (including agvet chemicals) be moved from the HSNO Act into a new Health and Safety at Work (HSW) Act. The HSW Act came into force in April, 2016 but the HSW regulations relating to hazardous substances are expected to come into force in the middle of 2017.

4.10 The New Zealand EPA will continue to receive applications for hazardous substances, assess their risks and decide whether they should be approved for use in New Zealand. The EPA will also

41 http://www.unece.org/trans/danger/publi/ghs/implementation_e.html 42 http://www.epa.govt.nz/search-databases/pages/hsno-ccid.aspx 43 http://www.unece.org/trans/danger/publi/ghs/implementation_e.html#c25877 44 http://www.epa.govt.nz/Publications/hsnogen-labelling-guide.pdf 45 http://www.epa.govt.nz/Publications/hsnogen-ghs-nz-hazard.pdf

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This is a draft document. As it is a work in progress it may be incomplete, contain preliminary conclusions and may change. You must not rely on, disclose or refer to it in any document. We accept no duty of care or liability to you or any third party for any loss suffered in connection with the use of this document.

This is a draft document. As it is a work in progress it may be incomplete, contain preliminary conclusions and may change. You must not rely on, disclose or refer to it in any document. We accept no duty of care or liability to you or any third party for any loss suffered in connection with the use of this document.

This is a draft document. As it is a work in progress it may be incomplete, contain preliminary conclusions and may change. You must not rely on, disclose or refer to it in any document. We accept no duty of care or liability to you or any third party for any loss suffered in connection with the use of this document.

Hazard vs. risk-based regulatory approaches for labelling

continue to be responsible for setting the rules for classification, labelling, SDS, packaging and the protection of the environment and public health. Following the transition, the EPA will no longer set rules on the use, handling, storage or manufacture of hazardous substances in the workplace (including agvet chemicals). These rules are being moved to the HSW regulations and will be overseen by WorkSafe New Zealand. The EPA has provided a summary table of hazardous substances regulatory responsibilities between the EPA and WorkSafe New Zealand when the regulatory changes occur.46

GHS labelling approach for agricultural and veterinary chemicals4.11 For the purposes of labelling under the HSNO, the EPA advises there is a mixture of performance

standards, prescription of GHS and acceptance of designated overseas labelling, including Australia47. Labelling requirements for hazardous substances can be met by complying with any of the following:

a. The Hazardous Substances Regulations

b. GHS

c. Approved Codes of Practice.

4.12 New Zealand provides a degree of flexibility to allow for both risk-based and hazard-based labelling. Currently, there is no one rule for the labelling of agricultural chemicals in New Zealand. Instead, the New Zealand EPA has developed a Technical Guide (based on the GHS) for the ‘Labelling of hazardous substances – hazard and precautionary information’, January 2012 which provides a procedure (guide) to be used to locate the signal word, pictograms, and hazard and precautionary statements required for any particular hazardous substance, some of which are likely to be agvet chemicals48.

4.13 The current labelling requirements are contained in 2001 HSNO regulations. These are performance based and while they allow for the use of GHS labelling elements they do not make this mandatory. For example, the Identification Regulations have requirements:

a. For acutely toxic substances to be identified with an indication it is toxic and an indication of its general degree and type of hazard. While these could be met by using the GHS (or transport) ‘skull and crossbones’ pictogram and the GHS hazard statements such as ‘Fatal if swallowed’ or ‘Toxic in contact with skin’ (for example), they do not have to be.

b. For all toxic substances, including those classified as sensitisers or with chronic toxicity classifications, to be identified with an indication of:

i. its general degree and type of hazard

ii. the circumstances in which it may harm human beings (usually a description of the exposure route)

iii. the kinds of harm it may cause to human beings, and its likely extent

iv. the steps to be taken to prevent harm to human beings.

There is also a requirement to identify the components of the product that give the product acute toxicity (unless this is low), or sensitiser or chronic toxicity classifications, and the concentrations of those ingredients in the product. The GHS concentration cut-offs are used for this.

c. For substances classified as ecotoxic (noting that the HSNO classification regulations classify for terrestrial ecotoxic hazards as well as the GHS equivalent aquatic ecotoxicity hazards), to be identified with an indication:

i. it is ecotoxic

ii. of its general type and degree of hazard

iii. of the circumstances in which it may harm living organisms

46 http://www.epa.govt.nz/PublishingImages/updated_transfer_functions_760.png 47 See slide 17 http://www.epa.govt.nz/Publications/HS_Reform_EPA_Notices_Stakeholder_Workshops_Nov_2014.pdf 48 http://www.epa.govt.nz/Publications/hsnogen-labelling-guide.pdf

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This is a draft document. As it is a work in progress it may be incomplete, contain preliminary conclusions and may change. You must not rely on, disclose or refer to it in any document. We accept no duty of care or liability to you or any third party for any loss suffered in connection with the use of this document.

This is a draft document. As it is a work in progress it may be incomplete, contain preliminary conclusions and may change. You must not rely on, disclose or refer to it in any document. We accept no duty of care or liability to you or any third party for any loss suffered in connection with the use of this document.

This is a draft document. As it is a work in progress it may be incomplete, contain preliminary conclusions and may change. You must not rely on, disclose or refer to it in any document. We accept no duty of care or liability to you or any third party for any loss suffered in connection with the use of this document.

Hazard vs. risk-based regulatory approaches for labelling

iv. of the kind and extent of harm it is likely to cause living organisms

v. of the steps to be taken to prevent harm to living organisms.

Again, these requirements could be met by use of the GHS label elements, including the ‘dead fish and tree’ pictogram, but this is not mandatory.

4.14 The regulatory requirements for veterinary medicines are the same as for agricultural chemicals except that there is the alternative process for approvals through Group Standards. These are group approvals in place under HSNO, including the Veterinary Medicine (Limited Pack Size, Finished Dose) Group Standard 201249 (the Standard). In Schedule 1, clause 2(4) on page 7 of the Standard there is a requirement relating to veterinary medicines for GHS hazard and precautionary statements, but not pictograms. However, subclause (6) then states ‘The information specified in subclause (4) is only required for a specific hazard classification if a corresponding exposure risk is likely to occur during the intended use of the substance.’ That is, allowing risk based labelling.

4.15 The other two group standards for veterinary medicines (for uses that could have greater exposures) do not have this ‘exemption’ in them, but all of the group standards do have in the ‘Alternative compliance measures’ section the following provision:

“The requirements of subclauses (1) to (7) [might vary between the group standards but refers to the prescribed labelling requirements of the group standard] do not need to be met if a substance complies with the relevant labelling requirements of Australia, USA, Canada, the European Union, or any other country as approved by the Authority, as if the substances were for sale or supply in those countries.”

That is, a registered veterinary medicine from Australia labelled in accordance with the SUSMP and FAISD would be acceptable in New Zealand, in respect of HSNO requirements.

Rationale and policy reasons for the adopted labelling approach for agvet chemicals4.16 Our research did not find material which directly answered New Zealand’s policy reasons for the mix

of acceptable labelling approaches. However the publicly available EPA and WorkSafe New Zealand information suggests the policy reasons include:

a. health and safety

b. international consistency with the GHS

c. a high degree of ‘pragmatism’ through flexibility and recognition of overseas labels to maximise chemical access in New Zealand.

49 http://www.epa.govt.nz/Publications/ERMA200922%20Finished%20Dose%20GS.pdf

Department of Agriculture and Water Resources Desk-top assessment of international approaches to incorporating the Globally Harmonised System of Classification and Labelling of Chemicals in agricultural and veterinary chemicals regulation 17

This is a draft document. As it is a work in progress it may be incomplete, contain preliminary conclusions and may change. You must not rely on, disclose or refer to it in any document. We accept no duty of care or liability to you or any third party for any loss suffered in connection with the use of this document.

This is a draft document. As it is a work in progress it may be incomplete, contain preliminary conclusions and may change. You must not rely on, disclose or refer to it in any document. We accept no duty of care or liability to you or any third party for any loss suffered in connection with the use of this document.

This is a draft document. As it is a work in progress it may be incomplete, contain preliminary conclusions and may change. You must not rely on, disclose or refer to it in any document. We accept no duty of care or liability to you or any third party for any loss suffered in connection with the use of this document.

Hazard vs. risk-based regulatory approaches for labelling

5 Japanese jurisdiction research outcomesGHS implementation generally in Japan5.1 Japan has implemented the GHS through its Industrial Safety and Health Law (ISHL) regulatory

framework. The Japan Industrial Standards (JIS) are the major standards available to apply classification, labelling and SDS with the GHS requirements and are outlined in JIS Z7252. Whilst these are voluntary industrial standards, some of them are more than voluntary with a notion of “obligatory to make effort to comply”.

5.2 There are four Ministries in Japan relevant to the GHS implementation. They are:

a. Ministry of Health, Labour and Welfare (MHLW)

b. Ministry of Economy, Trade and Industry (METI)

c. Ministry of the Environment (MOE)

d. Ministry of Land, Infrastructure, Transport and Tourism (MLITT)

5.3 The ISHL was the first legislation to introduce GHS into Japan for the purpose of health and safety at work. Japans ISHL requires GHS classification data for the following substances since 1 December 2006:

a. 99 designated chemicals for which labels are required according to Article 57 of ISHL

b. 640 designated chemicals for which SDSs are required according to Article 57-2 of ISHL.

5.4 Besides ISHL, Japan’s Pollutant Release and Transfer Register Law (PRTR law), which is a law concerning reporting, etc. of the release to the environment of specific chemicals substances and promoting improvement in their management, has also required SDSs for over 400 designated chemicals.

5.5 For other chemicals, GHS labelling and SDS are recommended but not mandatory50. Japan has published three industrial standards to facilitate GHS implementation: GHS classification (JIS Z7252), MSDS (JIS Z7250) and label (JIS Z7251).

Agvet chemical regulation system5.6 Japan’s Food and Agricultural Materials Inspection Centre (FAMIC), an incorporated administrative

agency participates in OECD meetings and contributes to the international harmonisation of registration systems for agricultural chemicals.

5.7 FAMIC also takes part in the Codex Committee on Pesticide Residue (CCPR) to work on the maximum residue limits (MRLs) of pesticides in foods and animal feeds.

5.8 Pursuant to Japan’s Agricultural Chemicals Regulation Law51 (ACRL), the purpose of which is to improve the quality of agricultural chemicals and to ensure their safe and proper use by introducing an agricultural chemical registration system to regulate their sale and use, the Minister of Agriculture, Forestry and Fisheries in Japan may set Official Standards. Article 2 of the ACRL states that manufacturers or importers shall be prohibited from manufacturing, processing, or importing agricultural chemicals, unless they register such chemicals with the Minister (unless they are “designated harmless agricultural chemicals”). Similarly to the APVMA application system in Australia, application forms from manufactures or importers must state the test results concerning efficacy, phytotoxicity, toxicity, and persistency of the agricultural chemicals together with samples52. Amongst other things, the application must relevantly include precautions for use or storage. Article 7 of the ACRL requires manufacturers and importers to provide certain information on the containers (or packages in the case where they are sold without containers) which includes details as to whether the agricultural chemicals are toxic to humans or livestock, description of the effects and methods for detoxification, if the chemicals are flammable, explosive, or likely to harm the skin, including a description of the effect, and precautions for the use or storage. Penalties for a breach of

50 http://www.cirs-reach.com/GHS/Japan_GHS_Implementation.html 51 Law No. 82 of July 1, 1948, last amended on 30 March 200752 http://www.acis.famic.go.jp/eng/hourei/regulation_law.htm

Department of Agriculture and Water Resources Desk-top assessment of international approaches to incorporating the Globally Harmonised System of Classification and Labelling of Chemicals in agricultural and veterinary chemicals regulation 18

This is a draft document. As it is a work in progress it may be incomplete, contain preliminary conclusions and may change. You must not rely on, disclose or refer to it in any document. We accept no duty of care or liability to you or any third party for any loss suffered in connection with the use of this document.

This is a draft document. As it is a work in progress it may be incomplete, contain preliminary conclusions and may change. You must not rely on, disclose or refer to it in any document. We accept no duty of care or liability to you or any third party for any loss suffered in connection with the use of this document.

This is a draft document. As it is a work in progress it may be incomplete, contain preliminary conclusions and may change. You must not rely on, disclose or refer to it in any document. We accept no duty of care or liability to you or any third party for any loss suffered in connection with the use of this document.

Hazard vs. risk-based regulatory approaches for labelling

the Article 2 or 7 of the ACRL may include imprisonment of up to three years and/or a fine of up to one million yen on any person.

5.9 Veterinary chemicals fall under the Pharmaceutical Affairs Act (Act No. 145 of 1960) in Japan. Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is responsible for the review process of veterinary chemicals as well as other pharmaceuticals and medical devices. The review process includes the evaluation of the quality, efficacy, and safety of drugs, medical devices and tissue-based products in light of the current scientific and technological standards53.

GHS labelling approach for agricultural and veterinary chemicals5.10 Unlike Australia, Japan has not sought to categorise the implementation of GHS by industry

(e.g. agriculture), but rather, by the classification of each hazardous chemical. As such, there is no general application that GHS labelling in Japan applies to agvet chemicals.

5.11 GHS implementation applies to the Ordinance and guideline under the Pollutant Release and Transfer Register Law (PRTR law) which implements GHS labelling and SDS requirements for 562 designated chemicals54. We are not in a position to know whether any of these designated chemicals (to which GHS labelling and SDS requirements apply in Japan) are, or are contained in agvet chemicals. One of the twenty four targeted business operators for the purposes of the PRTR law is warehousing (for farm products, gas and liquids)55.

5.12 The information in the SDSs for these designated chemicals (for the purpose of the PRTR law) is expanded to 16 headings corresponding to GHS and the provision of labelling is added. The labelling and SDS is followed by JIS Z7253.

5.13 We found no evidence that GHS labelling applies to veterinary medicines.

Rationale and policy reasons for the adopted labelling approach generally5.14 The JIS Z7253 for ‘Hazard communication of chemicals based on GHS – Labelling and Safety Data

Sheet’ in its English translated version of the introduction provides a health and safety rationale for its adoption stating that, “the hazard statement of chemicals is the most fundamental and most important in the preventative measures of disasters due to chemicals, or actions to be take in cases of accidents, etc…”56.

53 http://www.pmda.go.jp/files/000207945.pdf#page=20 54 List of Class 1 designated substances http://www.meti.go.jp/policy/chemical_management/law/msds/sin1shueng.pdf List of Class 2 designated substances http://www.meti.go.jp/policy/chemical_management/law/msds/sin2shueng.pdf 55 Outline of PRTR system http://www.meti.go.jp/policy/chemical_management/english/files/PRTRsystem.pdf

56http://www.webstore.jsa.or.jp/webstore/Com/FlowControl.jsp? lang=en&bunsyoId=JIS+Z+7253%3A2012&dantaiCd=JIS&status=1&pageNo=0

Department of Agriculture and Water Resources Desk-top assessment of international approaches to incorporating the Globally Harmonised System of Classification and Labelling of Chemicals in agricultural and veterinary chemicals regulation 19

This is a draft document. As it is a work in progress it may be incomplete, contain preliminary conclusions and may change. You must not rely on, disclose or refer to it in any document. We accept no duty of care or liability to you or any third party for any loss suffered in connection with the use of this document.

This is a draft document. As it is a work in progress it may be incomplete, contain preliminary conclusions and may change. You must not rely on, disclose or refer to it in any document. We accept no duty of care or liability to you or any third party for any loss suffered in connection with the use of this document.

This is a draft document. As it is a work in progress it may be incomplete, contain preliminary conclusions and may change. You must not rely on, disclose or refer to it in any document. We accept no duty of care or liability to you or any third party for any loss suffered in connection with the use of this document.

Hazard vs. risk-based regulatory approaches for labelling

6 Hazard vs. risk-based regulatory approaches for labelling

6.1 The GHS is a voluntary international system, in that it does not impose binding treaty obligations on countries. It explicitly envisages that competent authorities in many countries implement and maintain risk-based labelling regulatory approaches, and will continue to do so.

6.2 Hazard-based approaches, such as the GHS, are relevant to risk-based systems both for hazard assessment (which is necessary for informing risk assessments) and hazard communication for users. The GHS is not intended to harmonise risk assessment procedures and risk management decisions.

6.3 The Food and Agriculture Organization of the United Nations and World Health Organisation (FAO/WHO) in its revised publication on ‘International Code of Conduct on Pesticide management – Guidelines on Good Labelling Practice for Pesticides, August 2015’ (the guidelines)57 advise that pesticides are included in the GHS although it recommends classification and labelling should follow national legislation where this is available.

6.4 The guidelines explicitly target pesticide regulators, particularly in developing countries and those with economies in transition, which have to define or revise national pesticide labelling requirements58. They suggest that agvet chemical regulation could follow a GHS or FAO/WHO approach and include advice on how these provisions can be applied to pesticide labelling.

6.5 The guidelines acknowledge that hazard classification of the GHS refers principally to the hazards arising from the intrinsic properties of the pesticide. Both the guidelines and the GHS acknowledge that the harmonised elements of the GHS can be seen as a collection of “building blocks” from which to form a regulatory approach and countries are free to determine which of the building blocks will be applied in their jurisdictions. Recommendations in the guidelines are provided as to which building blocks of the GHS are most relevant to pesticide labelling, and how to implement them. In relation to labelling, in the absence of more detailed national standards, the guidelines recommend that these should be harmonised with systems such as the GHS or WHO Recommended Classification of Pesticides by Hazard, and the FAO/WHO code of conduct.

6.6 Noting their main target (developing countries and those with transitional economies that are defining or revising pesticide labelling requirements), the FAO/WHO guidelines recommend:

a. The use of the GHS harmonised signal words and hazard statements

b. Precautionary statements can be hazard or risk based. They are not internationally harmonised, and many countries will have national legal requirements and relevant national legislation should always be followed

c. Against mixing GHS and WHO classification for pesticide labelling.

6.7 For those countries which don’t have national legal requirements for precautionary statements, the GHS provides suggested precautionary statements based on the identified hazard category.

6.8 For countries that have well-developed systems for agricultural and veterinary chemicals regulation, the benefits of adopting GHS appear less clear. In Australia, for example, the Standard for the Uniform Scheduling of Medicines and Poisons and the Australian Code for the Transport of Dangerous Goods by Road & Rail, which apply to agvet chemicals (including labels), mandate the use of range of descriptive signal words/headings, including “Caution”, “Poison”, “Dangerous Poison”, “Controlled Drug”, “Flammable Liquid”, “Toxic”, “Corrosive” whereas the GHS has “Hazard” and “Warning”. Hazard statements are similarly targeted to align with the established (sophisticated) risk-based regulatory system. In addition, the GHS focuses principally on physicochemical and human health hazards and its application to environmental hazards is restricted to aquatic toxicity, whereas more fully-developed regulatory systems integrate aspects such as animal and plant health, a broad range of environmental considerations and other factors. In these cases, while there may be some harmonisation benefits from implementing GHS, any benefits that may be derived from GHS need to be considered and balanced against the impact to well-developed risk-based

57 http://www.fao.org/3/a-i4854e.pdf 58 http://www.fao.org/3/a-i4854e.pdf reference page 1 introduction

Department of Agriculture and Water Resources Desk-top assessment of international approaches to incorporating the Globally Harmonised System of Classification and Labelling of Chemicals in agricultural and veterinary chemicals regulation 20

This is a draft document. As it is a work in progress it may be incomplete, contain preliminary conclusions and may change. You must not rely on, disclose or refer to it in any document. We accept no duty of care or liability to you or any third party for any loss suffered in connection with the use of this document.

This is a draft document. As it is a work in progress it may be incomplete, contain preliminary conclusions and may change. You must not rely on, disclose or refer to it in any document. We accept no duty of care or liability to you or any third party for any loss suffered in connection with the use of this document.

This is a draft document. As it is a work in progress it may be incomplete, contain preliminary conclusions and may change. You must not rely on, disclose or refer to it in any document. We accept no duty of care or liability to you or any third party for any loss suffered in connection with the use of this document.

Hazard vs. risk-based regulatory approaches for labelling

systems, as well as inconsistencies and potential for confusion of information when compared with these existing systems.

While a major benefit of applying a GHS approach appears to be harmonisation of international trade, countries with well-developed risk-based agvet chemical regulatory systems will, in many cases, have existing unique labelling requirements (as is the case in Australia) and as a result, few additional benefits for agricultural and veterinary chemicals are likely to arise from international harmonisation.

Department of Agriculture and Water Resources Desk-top assessment of international approaches to incorporating the Globally Harmonised System of Classification and Labelling of Chemicals in agricultural and veterinary chemicals regulation 21