Canada – Consultation Summary: Notice of Intent Enhanced Transparency of the Pesticide Regulatory Process, NOI2022-01

Mar 18, 2023 | International

Health Canada’s Pest Management Regulatory Agency

17 March 2023

Table of Contents

The consultation
Summary of comments received
Conclusion

On 4 August 2021, the Ministers of Health, Agriculture and Agri-Food and Environment and Climate Change announced that the Government of Canada would be investing $42 million in Health Canada’s Pest Management Regulatory Agency (PMRA) to further strengthen its human and environmental health and safety oversight and protection, and improve transparency of the pesticide review process. Several strategies are in process of being implemented by the PMRA to make more information available to the public and enhance transparency of the pesticide regulatory process.

The consultation
On 25 October 2022, the PMRA published a Notice of Intent and initiated a 30-day consultation on a proposal for enhanced transparency of the pesticide regulatory process (NOI2022-01). The proposal outlined PMRA’s intent to disclose the names of applicants and registrants once the review process is initiated, for those pre- and post-market reviews described in Appendix I. This would consist of the name of any person, including an individual, who is an applicant or registrant and would appear in:

The electronic public registry (via the Pesticide Product Information Database (PPID);
Consultation documents posted on the Pesticides section of the Canada.ca website (in other words, Proposed Registration Decision (PRD) and Proposed Maximum Residue Limit (PMRL)); and subsequently
Registration Decision documents.

In total, eleven responses were received. Nine responses were from industry stakeholders and two from non-governmental organizations (NGOs). Of note, comments received that went beyond what the proposal set out in the consultation document were not considered for the purpose of this proposal.

Summary of comments received

Comments from NGOs and some industry stakeholders confirmed support for PMRA’s proposal.

Overall, there is strong support for this PMRA initiative to enhance the transparency of the pesticide regulatory process that will improve confidence in the regulatory system. There is agreement that this initiative aligns with the Government of Canada’s commitment of August 2021. There is support to align with similar transparency practices implemented by other branches of Health Canada and international pesticide regulators such as the United States Environmental Protection Agency (USEPA) and the Australian Pesticides and Veterinary Medicines Authority (APVMA) for applications pending a regulatory decision. Disclosing regulatory ownership of review activities requested of the PMRA was acknowledged as key to transparency for the public.

Some industry stakeholders requested additional clarifications on who is considered to be the applicant in the context of this proposal and whether there is a distinction between applicant and registrant.

PMRA response:

The term “applicant” is not defined in the Pest Control Products Act or the Pest Control Product Regulations, whereas the term “registrant’’ is defined as “a person in whose name a pest control product is registered.” However, in the Act and Regulations, the term “applicant” is used to mean a person who makes an application:

to register or amend the registration of a pest control product under section 7 of the Pest Control Products Act,
to have an MRL specified for an unregistered active ingredient or an unregistered use under section 10 of the Pest Control Products Act, and
to renew a registered pest control product under section 16 of the Pest Control Product Regulations.

The “applicant’s name” refers to the name of the proposed or current registrant as identified in the Application Form for New or Amended Registration (form 6005), Box 3 Registrant Name (full legal name, no abbreviations). The registrant’s name is the intended or current registrant of the product, in whose name the Certificate of Registration would be issued.

The applicant’s or registrant’s name, whether the name of an individual, a company or another organization, will be made publicly available in the PPID, in Consultation Documents posted on Pesticides section of Canada.ca (in other words, PRD and PMRL, and subsequently in Registration Decision (RD) documents.

Some industry stakeholders commented that the PMRA’s proposal may impact the protection of the intellectual property of Canadian innovators and affect commercial interests, resulting in a competitive disadvantage.

PMRA response:

This proposal is consistent with the approach taken by Health Canada in respect of regulated products under the Food and Drugs Act. Since the implementation of the disclosure of applicant’s or registrant’s name for drug applications in 2015, stakeholders have not raised any concerns about a negative impact on their commercial interests. The PMRA does not expect any negative impact on commercial interests of disclosure of the names of applicants or registrants for pest control product applications. While it may be possible for the PMRA to receive an application for a new active ingredient or new innovative device for which there is a patent application pending, it is expected that this would happen on rare occasions. This type of situation could be managed on a case-by-case basis when an applicant or registrant identifies within their application cover letter that a patent application is pending, including the information required for verification. Additionally, while the PMRA proposes to disclose the applicant’s or registrant’s name, it will continue to maintain confidentiality of the product name while the application is under review, and when an application is withdrawn including instances where applications are rejected prior to making it to a full science review assessment. These considerations are expected to support the protection of intellectual property of Canadian innovators and allow the applicant to pursue its innovation efforts at a later date, as needed.

Some industry stakeholders questioned the transparency benefits and objective of disclosing the applicant’s or registrant’s name.

PMRA response:

In support of the Government of Canada’s initiatives towards Open Government as well as its commitment to enhanced transparency of the pesticide review process, additional information is being released in the PPID.  Currently the following information is released in the Public Registry for open applications for a variety of regulatory activities:

Application number and date received
Active ingredient(s)
Purpose (i.e., new, amendment, minor use)
Category of application (i.e., A, B, C, L, etc.)
Product type (i.e., insecticide, material preservative)
Marketing class (i.e., technical, commercial, domestic)

The addition of the applicant’s or registrant’s name will provide additional information about the application that has been filed to further support meaningful public participation in the regulatory process. PMRA recognizes that the transparency and openness of its work is critical in strengthening trust in the regulatory decisions. Disclosing the applicant’s or registrant’s name in the public registry is a first step in revisiting the types of information and data that we make available.

Some industry stakeholders commented that the PMRA’s proposal may lead to brand stigmatization, specifically when an applicant’s or registrant’s name is disclosed in relation to a negative outcome.

PMRA Response:

Following a review of the information and comments provided during consultation, the PMRA conducted an analysis of additional considerations. This analysis, which included the review of historical pest control product applications, confirmed that the applicant’s or registrant’s name has never been designated as confidential business information (CBI). This supports PMRA’s view that an applicant’s or registrant’s identity is unlikely to be information that meets the definition of CBI under the Pest Control Products Act, even when disclosed in association with the information that is already disclosed during the application review stage.

As described above, the PMRA will continue to maintain confidentiality of the product name, while the application is under review, and in certain instances of a negative outcome. This is expected to minimize brand stigmatization and limit prejudice in the marketplace, allowing the applicant to pursue re-application for their new or amended pest control product at a later date, as needed. It is PMRA’s position that the disclosure of the applicant’s or registrant’s name in relation to a negative outcome is not expected to lead to brand stigmatization or prejudice competitive position in the marketplace.

Conclusion
Following consideration of the comments received from stakeholders, as of 1 April 2023, the PMRA will be implementing the disclosure of the names of applicants, after administrative screening of a complete application package, once the application enters the review stream, for a variety of regulatory activities.

This information will be included in:

The Register (via the PPID) for applicable applications received on or after 1 April 2023; and
Consultation (in other words, PRD, PMRL) and Registration Decision documents posted on the Pesticides section of Canada.ca for applicable applications received on or after 1 April 2023.

Appendix I Types of regulatory activities released in the pesticide product information database
Category A – New Active Ingredients, Major New Uses, Maximum Residue Limits on unregistered active ingredients.

Category B – New or Amendments to Existing Registrations plus Emergency Registrations

Category C – Precedent Based Registrations and Amendments plus Minor Use Registrations

Category D – Importation for Manufacturing and Export Program (IMEP), User Requested Minor Use Label Expansion (URMULE), Master Copies, Private Labels, Renewals, Discontinuations

Category H – Notices of Objection and Review Panels

Category L – Data Protection Applications and Registrations

Category N and R – Re-Evaluations and Special Reviews

TRAI releases Consultation Paper on “Data Communication Services between Aircraft and Ground Stations provided by Organizations other than Airports Authority of India”

Dec 11, 2022 | Business

The Telecom Regulatory Authority of India (TRAI) has released a Consultation Paper on “Data Communication Services between Aircraft and Ground Stations provided by Organizations other than Airports Authority of India”, here yesterday.

Department of Telecommunication (DoT), through its letter dated 12th April 2022, has inter-alia stated that VHF data link services consist of the data for the tracking the aircraft for safety of flights. The Ministry of Communications has made frequency assignments to M/s Société Internationale de TélécommunicationsAéronautique (SITA) and M/s Bird Consultancy Services (BCS) to operate VHF Data Communication Link between aircrafts and ground stations.Considering that VHF Data Link Services to provide Aircraft Communication Addressing and Reporting (ACAR) service can be beneficial to track aircrafts on a real-time basis and help investigations/ search and rescue operations in the unfortunate event of aviation disaster, DoT has requested TRAI under the terms of clause 11(1)(a) of TRAI Act, 1997 (as amended) to provide recommendations on the following:

  1. An appropriate mechanism to regulate the services provided by these organizations;
  2. The manner in which the frequency assignment should be made to these organizations, in light of the supreme Court judgment made in the 2G case in 2012 – to assign radio frequencies only through auction.

In this regard, a Consultation Paper on “Data Communication Services Between Aircraft and Ground Stations Provided by Organizations Other Than Airports Authority of India”, seeking inputs from stakeholders have been placed on TRAl’s website (www.trai.gov.in). Written comments on the issues raised in the Consultation Paper are invited from stakeholders by 9th January 2023 and counter comments by 23rdJanuary 2023.

The comments/ counter-comments may be sent, preferably in electronic form at advmn@trai.gov.in. For any clarification/ information, Shri Akhilesh Kumar Trivedi, Advisor (Networks, Spectrum and Licensing), TRAI may be contacted at Telephone Number +91-11-23210481.

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Hong Kong – Consultation Paper on Cyber-Dependent Crimes and Jurisdictional Issues published (with photo/video)

Jul 20, 2022 | International

Consultation Paper on Cyber-Dependent Crimes and Jurisdictional Issues published (with photo/video)

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The following is issued on behalf of the Law Reform Commission:



     The Cybercrime Sub-committee of the Law Reform Commission published the Consultation Paper on Cyber-Dependent Crimes and Jurisdictional Issues today (July 20), making preliminary proposals for law reform to address the challenges to protection of individuals’ rights caused by the rapid developments associated with information technology, the computer and internet, and the potential for them to be exploited for carrying out criminal activities.



     This consultation paper comprises the first part of the study on cybercrime. It addresses five cyber-dependent crimes, which are crimes that can be committed only through the use of information and communications technology devices, where such devices are both the tool for committing the crimes and the target of the crimes. The five cyber-dependent crimes are illegal access to program or data, illegal interception of computer data, illegal interference of computer data, illegal interference of computer system, and making available or possessing a device or data for committing a crime.



     Currently, no single ordinance in Hong Kong deals with cybercrime specifically. Different offences are covered in the Crimes Ordinance (Cap 200) (CO) and the Telecommunications Ordinance (Cap 106) (TO), some of which are outdated. The Sub-committee has considered the laws of seven other jurisdictions, namely Australia, Canada, England and Wales, Mainland China, New Zealand, Singapore and the United States. A comparative study reveals that these jurisdictions have all provided for the five cyber-dependent crimes and their related jurisdictional issues either by enacting bespoke cybercrime legislation, or dedicating a part of their codified law to cybercrime.



     The main recommendations in the paper are:



(i) A new piece of bespoke legislation on cybercrime should be enacted to cover the five types of offences proposed in the paper and to prescribe their applicable jurisdictional rules;



(ii) There should be a new offence of unauthorised access to program or data, subject to a statutory defence of reasonable excuse. This offence would apply no matter whether access to a computer is obtained by telecommunications or not, and would therefore enhance the existing section 27A of the TO (which only targets unauthorised access to a computer by “telecommunications” as defined in that ordinance). In view of the potentially serious harm that an offender may further cause after accessing program or data, the Sub-committee proposes that unauthorised access with intent to carry out further criminal activity should constitute an aggravated offence;



(iii) There should be a new offence of unauthorised interception, disclosure or use of computer data carried out for a dishonest or criminal purpose. This offence would apply to data generally, including metadata (i.e. information about a communication), data in transit and data momentarily at rest during transmission, and would therefore offer better protection to communications by members of the public than the existing section 27(b) of the TO (which is predicated on a telecommunications context);



(iv) The existing provisions regarding “misuse of a computer” in sections 59(1A), 60 and 64(2) of the CO should be transposed into the new legislation to provide for the offences of illegal interference of computer data and computer system. The new legislation should retain the breadth of the existing law, and the opportunity can be taken to refine the statutory definition of “misuse of a computer”, e.g. by incorporating notions such as “impair the operation of any computer” into it;



(v) After the provisions on “misuse of a computer” are reorganised in the above manner, a provision corresponding to the existing section 62 of the CO (possessing anything with intent to destroy or damage property) should be introduced in the new legislation to include an offence of knowingly making available or possessing a device or data for committing a crime. The relevant elements of this offence would be made out as long as the primary use of the device or data is for committing an offence, regardless of whether or not it can be used for any legitimate purposes. An aggravated offence would occur where the perpetrator intends to use the device or data to commit an offence. To avoid over-criminalisation, a statutory defence of reasonable excuse would apply to both the basic and aggravated forms of the offence;



(vi) The nature of cybercrime justifies extra-territorial application of Hong Kong law. Hong Kong courts should have jurisdiction in a case where connections with Hong Kong exist. As an illustration, Hong Kong courts may assume jurisdiction if the perpetrator’s act has caused or may cause serious damage to Hong Kong; and



(vii) Recognising that the severity of the harm caused by cybercrime has a wide range, each of the five proposed cyber-dependent offences has two maximum sentences, one applicable to summary convictions (two years’ imprisonment) and the other to convictions on indictment (14 years’ imprisonment).



     When devising the above recommendations, the Sub-committee observes the guiding principles of balancing the rights of netizens and the interests of persons in the information technology industry against the need to protect the public’s interest and right not to be disturbed or attacked when using or operating their computer system.



     The Sub-committee welcomes views, comments and suggestions on any issues discussed in the consultation paper, including:



(i) whether there should be any specific defence or exemption for unauthorised access for cybersecurity purposes;



(ii) whether there should be exemptions from criminal liability for interception and use of data (including metadata) in favour of any professions and businesses;



(iii) whether the proposed offence of illegal interference of computer system should provide for lawful excuses for both cybersecurity professionals and non-security professionals; and



(iv) whether there should be a defence or exemption for the offence of knowingly making available or possessing computer data that can only be used to perform a cyberattack.



     All views should be submitted on or before October 19 to the Secretary of the Cybercrime Sub-committee, Law Reform Commission, by mail (4/F, East Wing, Justice Place, 18 Lower Albert Road, Central), by fax (3918 4096) or by email (hklrc@hkreform.gov.hk).



     The consultation paper and the executive summary can also be accessed on the Commission’s website at www.hkreform.gov.hk. Hard copies of the consultation paper are also available on request from the Secretariat of the Law Reform Commission at the above address.

Public Consultation on Draft National Data Governance Framework Policy

Jun 17, 2022 | Business


A stakeholder interaction on the Draft National Data Governance Framework Policy was held in the presence of Shri Rajeev Chandrasekhar, Minister of State, Electronics & Information Technology and Skill Development & Entrepreneurship, on 14th June 2022 at India Habitat Center in New Delhi.


There was a participation from over 250 stakeholders from industry, start-ups, academia, think tanks, international alliances & government officials from various ministries.


Minister of State, Shri Rajeev Chandrasekhar, highlighted the rapid digitalization of the government and Nagriks, within India, and the subsequent rise in data volumes necessitating a framework for harnessing the potential of this data. He stated that the Narendra Modi Government’s vision is to build a modern framework for Data Governance that will be kinetic enabler of India’s Digital Economy. NDGFP aims at standardising Government’s Data collection and management while catalysing AI and Data led research and startup ecosystem, he added.


The Minister of State also highlighted the importance of private stakeholders in participating in the overall data ecosystem and emphasized the government’s focus on ensuring a collaborative and participative approach towards this policy and its implementation.  “PM Narendra Modi encourages Public Consultation as most effective way to develop policies with wide inputs from wide universe of Stakeholders. The Ministry of Electronics and IT follows Public consultation to ensure Global standard laws for India’s Globally competitive Digital Economy and Startups”, said Rajeev Chandrasekhar


Shri Alkesh Kumar Sharma, Secretary, Ministry of Electronics and Information Technology provided a brief overview of the Draft National Data Governance Framework Policy emphasizing on the importance of following a whole-of-government approach towards data governance.


Dr. Rajendra Kumar, Additional Secretary, Ministry of Electronics and Information Technology, presented a detailed view of the key provisions of the Draft National Data Governance Framework Policy.


The draft policy and the sound foundation upon which it is built will focus on improving the institutional framework for government data sharing, promoting principles around privacy and security by design, encouraging the use of anonymization tools and ensuring equitable access to non-personal data for both the public and private sector.


Various suggestions included the continuation of the consultative process informing the functioning of the IDMO, provisions for harnessing the future potential of integrated datasets and clarifications around the nature of engagement with private players. Furthermore, information and clarity on the operations of the India Data Management Office, access to annotated datasets for AI innovation and active collaboration with private sector and social impact firms to build data capacity was suggested.


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Hong Kong – Public consultation on draft Courts (Remote Hearing) Bill launched

Jun 16, 2022 | International

Public consultation on draft Courts (Remote Hearing) Bill launched

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The following is issued on behalf of the Judiciary:



     The Judiciary today (June 16) launched a three-month public consultation on the draft Courts (Remote Hearing) Bill. To illustrate how the Bill will operate upon enactment, the Judiciary has also prepared the draft Practice Directions and the draft Operational Guidelines, which set out the administrative and operational details for the conduct of remote hearing. Legal professionals, interested parties and members of the public are invited to offer their views on the draft Bill, draft Practice Directions and draft Operational Guidelines by September 15.

 

     A spokesman for the Judiciary said, “At present, owing to legal impediments, most criminal cases cannot be heard remotely. For civil proceedings, while there is no question of legal impediments, there are no express provisions setting out how matters pertinent to a remote hearing shall be handled.

 

     “The Bill seeks to provide a comprehensive legal framework concerning the application, operation and effect of remote hearings for court proceedings in Hong Kong. It provides a clear legal basis for Judges and Judicial Officers to order remote hearings at various levels of courts and tribunals where appropriate, having regard to all relevant factors, as well as the dual requirements of open justice and fair hearing.”

 

     The major features of the Bill include:

 

  1. Details of the making of a remote hearing order, including safeguards for parties to ensure the fair disposal of remote hearings;

  2. Operation and legal effect of remote hearings;

  3. Safeguards for open justice in remote hearings; and

  4. Proposed new offences for the recording and publishing of remote and physical court hearings, as well as the broadcast of such hearings.


 

     “While the Bill provides a general framework to enable the use of remote hearings for all types of court proceedings, we plan to adopt an incremental approach in implementation by excluding certain proceedings, such as criminal trials, and persons from the application of the Bill at the initial stage,” the spokesman said.  



     The draft Bill, draft Practice Directions and draft Operational Guidelines will be refined in light of the comments received during the consultation as appropriate before it is introduced to the Legislative Council. 



     The consultation document is available at the Judiciary’s website (www.judiciary.hk/remote_hearing_bill/consultation_doc/eng.pdf). Views can be submitted via:

 

Email: remote_hearing_bill@judiciary.hk

 

Fax: 2501 4636

 

Mail: Planning and Development Division,

        Judiciary,                                                              

        Room 802-808, 8/F, High Block,

        Queensway Government Offices,

        66 Queensway, Hong Kong