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Health Canada Announces Proposal to Limit the Personal Use Import Exemption for Unregistered Pesticides

Health Canada has announced a draft amendment to the Pest Control Products Regulations to revise the current personal use import exemption to prohibit certain unregistered pesticides from entering Canada.  Currently, the regulations allow unregistered pesticides to be imported into Canada for personal use when the pesticide is 500 grams (g) or 500 milliliters (mL) or less and when the value is $100 or less.  According to Health Canada, the exemption was originally put in place to allow travelers to carry small quantities of a pesticide, such as an insect repellant deemed to pose little or no risk, across the border.  However, Health Canada now cites concerns that the widespread use of the Internet to purchase goods online coupled with the increase in international travel could result in the influx of larger amounts of potentially toxic, unregistered pesticides entering the country.  Health Canada notes that the Canada Border Services Agency lacks the authority under current regulations to intercept these products before they cross the border.

 

In seeking to limit the exemption, the Health Canada proposal would allow the importation of unregistered pesticides only if they meet the following criteria:

 

  • imported directly by the importer for personal use (i.e., online purchases or deliveries would not be permitted),
  • 500 g or 500 mL (or less) per person,
  • it is equivalent to a Canadian registered domestic class product (the same active ingredient and concentration),
  • packaging and labeling is in either English or French,
  • it is in its original packaging with the original label intact, and
  • it must be registered or authorized for use in the country of origin (contains a government registration number on its packaging or label).

 

In announcing its proposal, Health Canada indicated that if left in its current form the importation exemption could erode the integrity of Canada’s pest control products regulatory regime.  For example, importers could circumvent the quantity limit established under the current exemption by placing many separate online orders via the Internet.  According to Health Canada, individuals and businesses could import “virtually unlimited quantities of unregistered pesticides for possible commercial use or resale.”  Consequently, products that have not gone through Canada’s rigorous review and approval process could end up occupying a larger share of the Canadian pesticide market thus resulting in lost sales for pesticide manufacturers and increased public health and safety risks.

 

Health Canada’s proposal was published in the February 11, 2017 edition of the Canada Gazette with a 30-day public comment period.  The proposal may be accessed by clicking here.

EPA Seeks Public Comment on its Interpretation of the Definition of a Label “Panel” in Relation to Placement of First Aid Statements

EPA is inviting public comment on its interpretation and clarification of the definition of a label “panel” and the placement of first aid statements on such labels based on the product’s Toxicity Category.  The Agency’s interpretation and clarification were set forth in a December 2016 memorandum in which the Agency explains that while the Code of Federal Regulations (CFR) does not specifically define the term “panel,” the CFR does nonetheless stipulate that first aid statements must appear on the front panel for Toxicity Category I products and any panel for Toxicity Category II and III products.  EPA plans to update its Label Review Manual to reflect this clarification of the term “panel” in relation to the placement of first aid statements on the label for Toxicity Category I products and, in preparation, has established a public comment period ending on March 7, 2017.  Comments may be submitted to EPA docket number EPA-HQ-OPP-2016-0545 which may be accessed by clicking here.

 

In its memorandum, EPA references PR Notice 2001-1 which states, “First aid statements for other than Toxicity Category I products may appear on the front, side or back panel of the label.  Any time first aid statements appear on the side or back panel of the label, EPA expects that a referral statement such as ‘see side/back panel for additional precautionary statements’ will appear on the front panel of the label near the signal word.  First aid statements appearing on the side or back panel of the label would then be grouped near the other precautionary labeling, yet be set apart or distinguishable from the other label text.”

 

The Agency reiterates its long-standing interpretation of the term “panel” as being that portion of a label that is immediately visible on a pesticide product at the time the pesticide is sold or distributed.  As such, first aid language must be readily seen on a visible panel (front, side or back depending on Toxicity Category) and may not be placed inside multi-page labeling (i.e., “extended text,” “accordion,” “saddle stitched,” “pull-out,” “booklet,” or other type of formatted labels) that would be accessible only by manually opening a booklet or unfolding accordion style pages.  EPA states that this interpretation of the term “panel” is consistent with the guidance contained in PR Notice 2001-1.  While EPA acknowledges that it will consider requests for alternative placement of first aid language on a case-by-case basis, the Agency underscores “it is unlikely we would allow Toxicity Category I first aid statements to be placed only within a fold-out label format.”

 

CPDA welcomes feedback from its member companies on the possible ramifications of the Agency’s interpretation of the term “panel.”  Please click here to read EPA’s memorandum.

EPA Delists 72 Inert Ingredients From Use in Pesticides

On December 20, 2016 EPA announced the removal of 72 inert ingredients from its list of chemicals approved for use in pesticide products.  The use of these substances in the future will require that they go through the Agency’s formal inert ingredient re-approval mechanism, a burdensome process that will require the submission of an extensive amount of data developed through very costly and time consuming testing required to demonstrate the safety of the chemical in question.  The type of data needed to evaluate a new inert ingredient includes studies to evaluate potential carcinogenicity, adverse reproductive effects, developmental toxicity, genotoxicity as well as environmental effects associated with any chemical substance that is persistent or bioaccumulative.

 

Some of the 72 inert ingredients are a subset of a larger list of 371 inert ingredients that were the subject of two petitions submitted to EPA in 2006 identifying these substances as hazardous and requesting that the Agency issue a rule requiring that the identities of these inert ingredients appear on the labels of pesticide products containing any of these chemicals in their formulations.

 

In its initial response to the petitions, EPA proposed an Advanced Notice of Proposed Rulemaking (ANPRM) published in the December 23, 2009 Federal Register.  The ANPRM solicited comment on a range of issues including the question of whether a rulemaking should be limited to mandatory disclosure of potentially hazardous ingredients or broadened in scope to require disclosure of most or all inert ingredient identities, regardless of hazard.  The ANPRM also sought feedback on other questions such as how disclosure would impact CBI protections for inert ingredients under Section 10 of FIFRA.  Subsequently, in a May 22, 2014 letter to the petitioners, EPA announced its decision to abandon pursuit of a rulemaking aimed at mandatory disclosure of inert ingredients.  The Agency cited the many complexities surrounding the issue of inert ingredient disclosure as well as the significant staff time and resources involved in the rulemaking process.  Instead, EPA set forth a series of alternative actions under consideration that it believed would reduce the presence of hazardous inert ingredients in specific pesticide products.  Among these was a proposal to remove from the approved list of inert ingredients those that are no longer being used in pesticide products.

 

The 72 inert ingredients recently delisted by EPA were originally the subject of a Notice published in the October 22, 2014 Federal Register in which the Agency proposed to revoke their approved status.  In the Notice, EPA explained that the list of 72 inert ingredients was generated by an Agency evaluation of pesticide product compositional information to determine which of those 371 chemical substances referenced in the 2006 petitions and listed as inert ingredients on the EPA-approved list are in use or not in use in currently registered pesticide formulations.  The Agency noted that its proposed action would fulfill one of its commitments as described in the May 22, 2014 amended response to the petitioners.

 

On January 20, 2015, CPDA submitted comments to EPA on the delisting proposal, emphasizing that such action is not in accordance with EPA’s clear obligation under FIFRA to make risk-based decisions about registered pesticides (including their inert ingredients) and not hazard-based decisions based on their appearance on non-FIFRA related lists of hazardous substances.  Moreover, CPDA emphasized that removal of these inerts would subsequently require an expensive and time-consuming data generation and reapplication process in order to use them again.  CPDA also pointed out that it was not clear from the proposal whether EPA was focusing only on non-food use inerts, and that this delisting could inadvertently adversely affect tank-mix adjuvants that are used on food crops.  The ingredients in tank-mix adjuvants that are applied to food crops with pesticides must have a tolerance or exemption from a tolerance.  EPA’s review of pesticide formulations to determine whether an inert is currently being used would not have identified those approved inerts that are used in adjuvants applied with pesticides.  CPDA therefore asked EPA to confirm that food-use inerts are not part of this delisting, since they may be currently used in tank-mix adjuvants.  In addition, CPDA noted that one or more of these 72 inerts may be present in approved inerts as low concentrations of residual impurities such as unreacted monomers.  These impurities do not contribute to the function of the inert ingredient, but due to various regulatory list triggers, they may appear in product safety data sheets.  CPDA therefore requested that EPA confirm that these residual impurities are not covered by the proposed action.

 

In the aftermath of EPA’s recent decision to remove the 72 chemical substances from the list of approved inerts, CPDA is seeking a better understanding of what factors prompted the Agency to finalize its proposal at this particular time.  CPDA will also engage with the Agency on appropriate next steps our member companies should take in response to this development.  In so doing, CPDA welcomes input from its member companies on devising a strategy in response to the Agency’s recent and unexpected decision to delist these products.

 

The list of the 72 inert ingredients may be accessed by clicking here.

OSHA Petition

HCS 2012

CPDA Calls Upon OSHA to Amend HCS 2012 Relabeling Requirements to Protect Warehouse Employees from Unnecessary Chemical Exposures and Ergonomic Risks

 

On May 24, 2016, the Council of Producers & Distributors of Agrotechnology, the Agricultural Retailers Association, the International Sanitary Supply Association, and the Society of Chemical Manufacturers and Affiliates submitted a petition to the U.S. Occupational Safety and Health Administration (OSHA) requesting that the Agency issue a Direct Final Rule to amend its 2012 Hazard Communication Standard (HCS 2012).  The revision sought by the petitioners would clarify that when firms handling products in sealed containers in warehouses become aware of significant new chemical hazard information they may comply with HCS 2012 by the electronic transmission of an updated label to downstream entities in a manner similar to how updated safety data sheets are transmitted.

CPDA is now working with Members of Congress in an effort to build support for the remedy to the HCS 2012 dilemma as set forth in the joint industry petition.

The cover letter accompanying the petition may be accessed by clicking here.  Following the submission of the petition, CPDA issued a news alert which may be accessed here.