REGULATORY NEWS FOR WEEK OF MARCH 4, 2020

• Health Canada launches consultation on good manufacturing practices for veterinary drugs

Health Canada is pleased to announce the release of Annex 4 to the Good manufacturing practices guide – Veterinary drugs (GUI-0012) for a 90-day stakeholder consultation period from February 19, 2020 to May 19, 2020. RDC has requested a copy of the draft guidance and will review with the Regulatory Affairs Committee – Food and Drugs Act sub-committee.

• Draft screening assessment for [1,1’-Biphenyl]-2-ol, sodium salt (SOPP) CAS RN 132-27-4

According to the information presented in the draft screening assessment, it is proposed that SOPP does not meet the criteria under section 64 of the Canadian Environmental Protection Act, 1999 (CEPA).

However, since SOPP is considered to have human health effects of concern, there may be concern for if exposure levels were to increase. Therefore, the Government of Canada is considering follow-up activities to track changes in commercial use patterns and human exposure to SOPP.

• Canada Border Services Agency year in review

The Canada Border Services Agency (CBSA) plays a vital role in upholding the integrity of our borders, helping to grow our economy and keeping Canadians safe. Acting as Canada’s first line of defence, the CBSA would like to highlight some of the results achieved last year, and how it contributed to protecting Canadians and communities.

• Alberta held emergency response exercise to build resiliency

This year’s exercise – known as Emergency Management Exercise 2020 or EMX 20 – is a realistic simulation of multiple tornadoes affecting the Edmonton, Red Deer and Calgary areas. When one or more devastating tornadoes occur, a ‘whole of society’ response is needed. All levels of government, municipalities, emergency management professionals, Indigenous groups, industry and non-government organizations are involved.

• British Columbia revises resource to help employers measure workplace noise

Calculating noise exposure can be difficult if you don’t have the expertise. This resource will help you conduct a noise survey at your workplace.

• Ontario changes to designated substances

If you have designated substances in your workplace, you need to know that Ontario has made changes to O. Reg. 490/09 – Designated Substances, including a new medical surveillance code. These changes took effect January 1, 2020.

• EPA updates Integrated Risk Information System (IRIS) Program

The Environmental Protection Agency’s (EPA) Integrated Risk Information System (IRIS) Program is announcing the release of an updated IRIS Program Outlook (February 2020) on the IRIS website. The document describes assessments that are currently in development and their projected public milestones. These assessments have been identified as high priority needs of the Agency. The anticipated dates of the IRIS activities communicated in this update are based on several factors, including complexity of the assessment products and the availability of resources.

• Chemical Identity CBI Claims for Active Chemicals on the TSCA Inventory

On February 19, 2020, EPA finalized a rule on the procedures for companies to substantiate their CBI claims for the specific chemical identities of substances on the TSCA inventory, as well as the plan for how the Agency will review the claims, the timeframes for EPA to complete reviews, and the annual posting of results.

• US publishes draft assessment for trichloroethylene (TCE)

In the February 2020 draft risk evaluation, EPA reviewed a suite of potential TCE exposures and made some initial determinations on risk. These preliminary determinations may change as EPA’s evaluation becomes more refined through the public comment and peer review processes.

• Federal Motor Carrier Safety Administration opens consult on Crime Prevention for Truckers

Federal Motor Carrier Safety Administration (FMCSA), announces its plan to submit the Information Collection Request (ICR) described below to the Office of Management and Budget (OMB) for review

and approval. This request, titled “Crime Prevention for Truckers,” will allow for a study to understand the prevalence, seriousness, and nature of the problem of harassment and assaults against minority and female truckers. Please send your comments by March 30, 2020.

• EPA determines 20 substances to be of low priority

As required by the Frank R. Lautenberg Chemical Safety for the 21st Century Act amendments to the Toxic Substances Control Act (TSCA) and implementing regulations, EPA is designating 20 chemical substances as Low-Priority Substances for which risk evaluation is not warranted at this time. This document provides the final designation for each of the chemical substances and instructions on how to access the chemical-specific information, analysis and basis used by EPA to make the final designation for each chemical substance.

• 11 chemicals placed on Authorisation List already largely substituted

The European Chemicals Agency (ECHA) carried out a market research to estimate the number of applications for 11 substances that the European Commission added to the Authorisation List in February 2020. Our research indicates that only a few companies are interested in continuing to use some of the 11 substances of very high concern. This is a strong and positive indication that the authorisation system is driving companies towards safer alternatives.

• Europe consulting on harmonized classification and labelling for 6 substances

ECHA is looking for comments on the harmonised classification and labelling proposals for:

• ethyl acrylate (EC 205-438-8, CAS 140-88-5);
• methyl acrylate; methyl propenoate (EC 202-500-6; CAS 96-33-3);
• allyl methacrylate; 2-methyl-2-propenoic acid 2-propenyl ester (EC 202-473-0, CAS 96-05-9)
• 6-[C12-18-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid, sodium and tris(2-hydroxyethyl)ammonium salts (EC 701-271-4, CAS -);
• 6-[C12-18-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid (EC 701-162-1, CAS -); and
• 6-[(C10-C13)-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid (EC 701-118-1; CAS 2156592-54-8).

• Europe consults on two persistent organic pollutants

ECHA has published two draft risk profiles for:

1. methoxychlor (EC 200-779-9, CAS 72-43-5) proposed by the EU;
2. Dechlorane Plus and its syn- and anti-isomers (EC -, CAS -) proposed by Norway.

Both substances have been proposed to be listed as persistent organic pollutants (POPs) under the Stockholm Convention. The proposals are currently under consideration by the Persistent Organic Pollutants Review Committee (POPRC). Comment the draft risk profiles by 15 April 2020. As of 2019, ECHA supports the Commission on regulating persistent organic pollutants.

Safety Share

• Take these steps to protect your business from contractor liability

When a business hires a contractor to undertake a construction project, who is the employer under the Occupational Health and Safety Act? An appeal of a recent court decision may upend our understanding of who this is.

• Shopping online? Check with CFIA before checking out

Just because a product is sold online, it does not mean it’s approved for import into Canada.

Bringing certain food, plants, plant products, animals or animal products across the border can pose a serious risk to our resources and economy, not to mention your wallet! Know the risks and check in with us before you check out.