Regulatory Proposal
PRO2001-02
Harmonization of environmental chemistry and fate data requirements under NAFTA
Her Majesty the
Queen in Right of Canada,
represented by the
Minister of Public Works and Government Services Canada 5oct01
source:
http://dsp-psd.pwgsc.gc.ca/Collection/H113-8-2001-2E.pdf
11dec01
Government of Canada Main Website (French and
English)
|
Comment on Canada's Regulatory Proposal
PRO2001-02 |
The purpose of this document is to provide information on proposed changes to the Pest Management Regulatory Agency’s environmental chemistry and fate data requirements for conventional chemical pesticides on terrestrial food crops (PMRA Use–Site Category 14). These proposed changes implement the agreements reached with the United States Environmental Protection Agency under the North American Free Trade Agreement Technical Working Group on Pesticides. It is proposed that these changes will come into effect on January 1, 2003.
Please provide any comments on this publication within 45 days of the date of release of this document to the Publications Coordinator at the address listed below.
(publié aussi en français)
October 5, 2001This document is published by the Submission Coordination and Documentation Division, Pest Management Regulatory Agency. For further information, please contact:
Publications Coordinator Internet: pmra_publications@hc-sc.gc.ca Pest Management Regulatory Agency www.hc-sc.gc.ca/pmra-arla/ Health Canada Information Service: 2720 Riverside Drive 1-800-267-6315 or (613) 736-3799 A.L. 6605C Facsimile: (613) 736-3798 Ottawa, Ontario K1A 0K9
ISBN: 0-662-31114-0
Catalogue number: H113-8/2001-2E-IN
© Her Majesty the Queen in Right of Canada, represented by the Minister of Public Works and Government Services Canada 2001
All rights reserved. No part of this information (publication or product) may be reproduced or transmitted in any form or by any means, electronic, mechanical photocopying, recording or otherwise, or stored in a retrieval system, without prior written permission of the Minister of Public Works and Government Services Canada, Ottawa, Ontario K1A 0S5.
The harmonization of pesticide regulatory requirements being carried out under the auspices of the North American Free Trade Agreement (NAFTA) Technical Working Group (TWG) on Pesticides is important for achieving the goal of one North American market for pesticides. This goal is articulated in the document known as the
North American Initiative (NAI). The NAI commits Canada’s Pest Management Regulatory Agency (PMRA) and the U.S. Environmental Protection Agency (EPA) to harmonize pesticide regulatory tools so that work sharing and joint review activities become routine.Changes to the PMRA environmental chemistry and fate data requirements for conventional chemical pesticides used in Use–Site Category (USC) 14 (Terrestrial Food Crops) are being proposed to implement the agreements1 reached with the U.S. EPA under the NAFTA. These changes are reflected in the attached USC 14 data code (DACO) table for the combined technical grade active ingredient (TGAI) and end-use product (EP) (Appendix 1). Identical changes will be made for corresponding data codes in the USC 14 TGAI and EP DACO Tables. The proposed changes do not jeopardize the stringency of the environmental data requirements nor the interpretation of the data with respect to environmental protection. It is proposed that these changes will come into effect on January 1, 2003. Applicants, however, are encouraged to accommodate these changes as soon as possible. Combinations of old and revised data requirements will not be acceptable. The EPA will be implementing these agreements on the same schedule through its normal processes until Code of Federal Regulations 40 Part 158 is revised. Highlights of the changes to the environmental chemistry and fate data requirements appear in the following summary tables.
Proposed revisions to USC 14 environmental chemistry data requirements for the TGAI
|
Data code |
Title |
Existing |
Proposed |
||
|
Data required |
Conditions |
Data required |
Conditions |
||
|
8.2 |
Laboratory Studies |
|
|
|
|
|
8.2.3.4 |
Biotransformation in Soil (TGAI) |
|
|||
|
8.2.3.4.4 |
Anaerobic Soil 20-30• C |
CR |
Can be
satisfied by |
R |
Can be
satisfied by |
|
8.2.3.5 |
Biotransformation in Aquatic Systems |
(TGAI) |
|
||
|
8.2.3.5.2 |
Aerobic Water 20-30• C |
R |
Preferred
over part |
R |
|
|
8.2.3.5.4 |
Aerobic
Water-Sediment |
CR |
III partitioning
into I |
R |
|
1 See Status of Harmonization of Data Requirements and Test Protocols for Pesticide Registration, Environmental Fate, NAFTA Technical Working Group on Pesticides, June 5, 2000.
|
Data code |
Title |
Existing |
Proposed |
||
|
Data required |
Conditions |
Data required |
Conditions |
||
|
8.2.3.5.6 |
Anaerobic Sediment Water |
R |
CR |
If partitioning into 20-30• C sediment is expected; likely to be upgraded to required (R) in the future for the purposes of model input |
|
|
8.2.4 |
Laboratory Studies of Mobility (TGAI) |
||||
|
8.2.4.2 |
Adsorption or Desorption |
CR |
One of 8.2.4.2, R |
||
|
8.2.4.3 Soil |
Column Leaching |
R |
|||
|
8.2.4.3.1 |
Unaged Soil |
CR |
See 8.2.4.2 |
||
|
8.2.4.3.2 Aged Soil |
CR |
See 8.2.4.2 |
|||
|
8.2.4.4 |
Soil Thin Layer Chromatography (TLC) Leaching |
CR |
See 8.2.4.2 |
||
R = required; CR = conditionally required; blank = not required.
With respect to the data requirements for laboratory studies of mobility, adsorption or desorption (8.2.4.2) and soil column leaching data (8.2.4.3) will now be required. The differentiation between unaged soil and aged soil column leaching (8.2.4.3.1 and 8.2.4.3.2, respectively) has been removed, as well as the requirement for soil TLC (8.2.4.4).
Proposed revisions to USC 14 environmental chemistry data requirements for the EP
|
Data code |
Title |
Existing |
Proposed |
||
|
Data required |
Conditions |
Data required |
Conditions |
||
|
8.3.3 |
Aquatic |
|
|
CR |
Based on potential for |
|
8.3.3.1 |
Canada |
CR |
Based on potential for |
|
|
|
8.3.3.2 |
Northern U.S. |
CR |
Can augment Canadian |
|
|
R = required; CR = conditionally required; blank = not required.
The changes to the environmental field study data requirements reflect the removal of the differentiation between Canadian and northern U.S. study sites. For the terrestrial field studies, the subsections 8.3.2.1 and 8.3.2.2 have been collapsed into 8.3.2. This does not affect the overall data requirements, as terrestrial field studies (Canadian or northern U.S.) remain required. Previously, available northern U.S. terrestrial field studies could substitute for some Canadian studies and consequently were denoted as "CR." Similarly, 8.3.3.1 and 8.3.3.2 have been combined into 8.3.3 for the aquatic field studies, which remain conditionally required.
Similar changes to several other outdoor USCs (4,7,13,16, 25, 27 and 30) will be addressed in a separate regulatory proposal.
List of abbreviations
CR conditionally required DACO data code EP end-use product EPA Environmental Protection Agency NAFTA North American Free Trade Agreement NAI North American Initiative PMRA Pest Management Regulatory Agency R required TGAI technical grade active ingredient TLC thin layer chromatography TWG Technical Working Group U.S. United States USC Use–Site Category
Appendix I Proposed USC 14 DACO requirements for the combined TGAI and EP
|
Data code |
Title |
Data required |
Conditions |
Volume no. |
|
8 |
Environmental Chemistry and Fate |
|||
|
8.1 |
Summaries |
R |
||
|
8.2 |
Laboratory Studies |
|||
|
8.2.1 |
Summary of Physicochemical |
R |
Data submitted under 2.14.7,
2.14.9, |
|
|
8.2.2 |
Analytical Methodology (parent |
|||
|
8.2.2.1 |
Soil |
R |
||
|
8.2.2.2 |
Sediment |
R |
||
|
8.2.2.3 |
Water |
R |
||
|
8.2.2.4 |
iota |
R |
||
|
8.2.3 |
Laboratory Studies of
Transformation |
|||
|
8.2.3.1 |
Summary |
R |
||
|
8.2.3.2 |
Hydrolysis |
R |
||
|
8.2.3.3 |
Phototransformation |
|||
|
8.2.3.3.1 |
Soil |
R |
||
|
8.2.3.3.2 |
Water |
R |
||
|
8.2.3.3.3 |
it |
CR |
If volatilization is indicated
by vapour |
|
|
8.2.3.4 |
Biotransformation in Soil (TGAI) |
|||
|
8.2.3.4.2 |
Aerobic Soil 20-30• C |
R |
||
|
8.2.3.4.4 |
aerobic Soil (Flooded) 20-30• C |
R |
Can be satisfied by 8.2.3.5.6 |
|
|
8.2.3.5 |
Biotransformation in Aquatic
Systems |
|||
|
8.2.3.5.2 |
Aerobic Water 20-30• C |
R |
||
|
8.2.3.5.4 |
Aerobic Water Sediment 20-30• C |
R |
1 |
|
|
Data code |
Title |
Data required |
Conditions |
Volume no. |
|
8.2.3.5.6 |
Aerobic Sediment Water 20-30• C |
CR |
If partitioning into sediment is
expected; |
|
|
8.2.3.6 |
Special Studies Related to Use
Pattern |
CR |
||
|
8.2.4 |
Laboratory Studies of Mobility (TGAI) |
|||
|
8.2.4.1 |
Summary |
R |
||
| 8.2.4.2 | Adsorption or Desorption | R | ||
| 8.2.4.3 | Soil Column Leaching | R | ||
| 8.2.4.5 | Volatilization | CR | If volatilization is
indicated by vapour pressure or Henry's Law Constant |
|
| 8.2.4.6 | Special Studies Related to Use
Pattern or Formulation (EP) |
CR | ||
| 8.3 | Field Studies of Dissipation and ccumulation [may be small or large scale] (EP) |
|||
| 8.3.1 | Summary | R | ||
| 8.3.2 | Terrestrial | R . | US field studies are
acceptable, if conducted at appropriate sites in relevant ecoregions |
|
| 8.3.3 | Aquatic | CR | Based on potential for
aquatic exposure and if pesticide residues have the otential for persistence, mobility, non- target aquatic toxicity or bioaccumulation; U.S. field studies are acceptable, if conducted at appropriate sites in relevant ecoregions |
|
| 8.3.4 | Special Studies Related to
Intended Use Pattern |
CR | Based on concerns arising
from results of other studies |
|
| 8.4 | Storage, Disposal and
Decontamination (TGAI and EP) |
|||
| 8.4.1 | Summary | R | ||
| 8.5 | Other Environmental Fate Studies (TG AI and EP) |
|||
| 8.5.1 | Summary | CR | Based on concerns arising
from results of other studies |
|
| 8.6 | Other Studies, Data and Reports | CR | If available |
|
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