August 16, 2006
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Health Canada’s Pest Management Regulatory Agency has
conducted its re-evaluation of lawn and turf uses of 2,4-D.
2,4-D is a herbicide commonly found in weed control products
used by homeowners on their lawns. Health Canada has proposed
that 2,4-D is acceptable for use on lawns and turf with specific
label directions for use and handling. Therefore, Health Canada
is proposing continued registration of 2,4-D for lawn and
turf use.
Health Canada is aware of the public’s concerns of
uses of pesticides on lawns and gardens (often referred to
as cosmetic or aesthetic uses). The PMRA has prepared the
following questions and answers on the re-evaluation of 2,4-D
and pesticide regulation in Canada to help clarify concerns
on the safety of pesticide use.
If you have any further questions regarding the re-evaluation
of 2,4-D or about any other pesticide issue, please contact
the PMRA’s Pest Management Information Service at 1-800-267-6315
or 613-736-3799 from outside of Canada (long distance charges
apply).
About the August 2006 Re-evaluation Note
What is the Re-evaluation Note?
Health Canada published its Proposed Acceptability for Continuing
Registration document PACR2005-01 for lawn and turf uses of
2,4-D for a 60-day comment period in February 2005. The PMRA
has published Re-evaluation Note REV2006-11 detailing the
interim measures in advance of its final decision regarding
the lawn and turf uses of 2,4-D. The Re-evaluation Note also
contains the responses to the comments received during the
comment period.
At this time, what additional measures are required by the
PMRA as a result of the re-evaluation?
The following changes were made as a result of the PMRA’s
review of the comments and information received:
- Statements indicating the most effective timing of
application are now required on product labels.
- Environmental precaution statements have been modified
to increase their relevancy to all products.
- The proposed buffer zones for commercial products have
been altered.
- Data on microcontaminants present at extremely low levels
must be submitted to the PMRA.
What are the next steps for 2,4-D?
The PMRA is expecting to release its proposed decision on
the agricultural uses of 2,4-D for a 60-day comment period
in late fall 2006. Once the comment period is closed and the
comments have been reviewed, the PMRA will release a final
decision on all uses of 2,4-D consistent with the new Pest
Control Products Act.
Can we provide comments on the Re-evaluation Note?
The PMRA is always open to receiving comments. However, this
document is not a formal request for comments. The Re-evaluation
Note is a document responding to comments received during
the 60-day comment period, which closed April 25, 2005. A
proposed decision on the agricultural uses of 2,4-D is slated
for publication and public comment in late fall 2006.
About the Health Canada’s re-evaluation of 2,4-D
How did Health Canada conclude that 2,4-D is acceptable,
when it is used according to label directions?
Health Canada conducted an exhaustive, four-year re-evaluation
of the broad body of information pertaining to the lawn and
turf uses of 2,4-D. This information included an extensive
proprietary database, published scientific information, foreign
reviews and any use pattern information collected by the PMRA.
The Re-evaluation Note contains further information on the
types of information assessed.
The PMRA examined all the scientific data and assessed them
to determine if products containing 2,4-D posed any health
or environmental concerns. This assessment consisted of:
- a human health risk assessment that looked at the
potential for 2,4-D to cause adverse health effects such
as cancer, birth defects and endocrine disruption;
- an assessment of all sources and routes (oral, dermal,
inhalation) of potential exposure to 2,4-D, including exposure
from the diet, drinking water and from contact with treated
areas like lawns and gardens;
- homeowner as well as occupational exposure assessments
(exposure encountered by the user/applicator of the product),
while 2,4-D is applied and after application;
- a human health risk assessment, which determines the
toxicity in relation to the amount of exposure in all potentially
exposed populations, including children;
- an environmental risk assessment that considered risks
to plants, birds, mammals and aquatic organisms as well
as fate in the environment; and
- an assessment of value as it relates to the efficacy
of the product.
To assess the risk to children from any potential 2,4-D exposure,
the PMRA also took into consideration the unique physiology,
behaviours and play habits of children, such as their body
weight and hand-to-mouth contact while playing on treated
grass.
The Agency also consulted with an independent Science Advisory
Panel that included university and government researchers
in toxicology, biology and epidemiology. The Panel agreed
with the PMRA’s risk assessment, which determined that
2,4-D is acceptable for use on lawns and turf with specific
label directions for use and handling.
The PMRA’s Information Note on Assessing Human Health
Risks During Pesticide Review in Canada provides additional
information on how potential effects to human health are assessed
during the review of pesticides.
Why did Health Canada re-evaluate 2,4-D?
As scientific knowledge evolves and new information becomes
available, the PMRA requires that registered pesticides be
re-evaluated according to modern risk assessment approaches.
The PMRA is currently re-evaluating all pesticides registered
before January 1, 1995, to ensure they meet modern health
and safety standards. This is part of our normal process and
is now required under the new Pest Control Products Act. See
the Information Note on the Re-evaluation of Pesticides Program for further details.
In 2000, the Agency also committed to re-evaluating the eight
most commonly used lawn and turf pesticides as part of its
Action Plan on Urban Use of Pesticides; 2,4-D is one of them.
Similar re-evaluation programs exist in other Organisation
for Economic Co-operation and Development (OECD) member countries
such as the United States and those in the European Union.
What are dioxins? Why should we worry about them?
Dioxins make up a large family of over 200 chemicals. Certain
types of dioxins are considered much more toxic than others
and are classified as “dioxins of concern.” In
the early 1980s, the methods used to manufacture 2,4-D were
carefully examined in light of the emerging knowledge and
concerns regarding these dioxins. Changes were made to reduce
the levels of contamination for all dioxins. In 1983, Agriculture
Canada’s Pesticides Division established a production
limit of “not detectable at 1 ppb” for 2,3,7,8–TCDD,
a dioxin of concern, in 2,4-D.
Since the 1980s, more sensitive analytical methodologies
have been developed. It is now possible to detect much lower
levels of dioxins in 2,4-D than before. The PMRA is requiring
additional data on dioxin levels that will are generated using
the most up-to-date analytical methods available.
Health Canada’s It’s Your Health: Dioxins and
Furans publication gives some additional information on dioxins
and lists the greatest sources for the presence of dioxins
in the environment, including the incineration of medical
and municipal waste, the burning of fuel and wood, electrical
power generation and tobacco smoke.
For more information on the dioxins in 2,4-D, please consult
Re-evaluation Note REV2006-11.
Can I find out the exact levels of dioxins in 2,4-D?
Levels of the dioxins and furans of concern, as listed in
The List of Pest Control Products Formulants and Contaminants
of Health or Environmental Concern (Canada Gazette, Part II,
November 30, 2005) are available for currently registered
technical class products in Canada.
Why does the PMRA request data from the technical grade of
2,4-D? Why not test the end-use products containing 2,4-D
that are actually for sale to the public?
The technical grade would have the highest level of dioxins.
Therefore, the analysis of the data of the technical grade
provides clearer evidence of the presence of dioxins.
Dioxins, if present in the product, are generated during
the manufacturing process of the technical grade active ingredient.
Any dioxins in an end-use product would have come from the
technical grade product that was used to formulate the final
product (i.e., what is purchased in store). The levels of
dioxins in the final products would therefore be proportionally
lower. If the percentage of the technical grade product used
to formulate the final product is very low, dioxins present
in the end product may be below the level of detection.
Have the dioxin levels in 2,4-D been monitored?
The dioxin levels in 2,4-D and other products were monitored
during and after the development of the regulatory standard
presented in Memorandum to Registrants R-1-216 in the 1980s.
It was because of this monitoring that newer manufacturing
processes were developed to meet these standards. With the
new manufacturing processes, the test data confirm that the
products are in compliance with the standard.
What is the review status of the other pesticides commonly
used in lawn-care?
On September 27, 2000, the PMRA announced the priority re-evaluation
of the eight (8) most commonly available lawn pesticides.
This re-evaluation uses modern scientific standards to determine
their continued acceptability for registration and whether
any changes need to be made to the conditions of registration
of these chemicals.
The re-evaluations are completed for four of the lawn pesticides.
As a result of these re-evaluations, the insecticides chlorpyrifos,
diazinon and malathion (broadcast turf use), and the herbicide
mecoprop, are being phased out. The re-evaluation review for
lawn and turf uses of 2,4-D was released in February 2005
and the proposed decision following the review of the agricultural
uses is expected in late fall 2006. The proposed decision
for the herbicide MCPA was published April 2006, and the herbicide
dicamba is slated for publication late 2006. The assessment
of the insecticide carbaryl is underway and expected to be
completed next fiscal year.
The medical community has noted associations between
2,4-D and serious illnesses in children. How can you say
it’s
acceptable for use?
When re-evaluating a pesticide, the PMRA has access to the
available scientific information on the product, including
laboratory, epidemiology and toxicology studies, scientific
reports and more. This allows the PMRA to conduct thorough
scientific assessments to determine if a product is acceptable
for use or not when used according to label directions. The
PMRA also examines the product’s uses, the amounts used
and the label instructions for each product.
For 2,4-D, the PMRA carefully considered the epidemiology
literature, some of which suggested weak associations, while
others suggested no link between adverse health effects and
the use of 2,4-D. In addition, the Agency reviewed the extensive
database of toxicology information that specifically looked
for the potential to cause adverse effects such as cancer.
The PMRA concluded that 2,4-D does not cause cancer and it
is acceptable for use by homeowners who choose to use it on
their lawns when they follow the directions on the label.
No other international regulatory body considers 2,4-D to
cause adverse health effects such as cancer, birth defects
or endocrine disruption. Based on all available and relevant
data, the Agency agrees with this position.
An Ontario College of Family Physicians’ Report published
in April of 2004 recommended that the public limit their exposure
to pesticides wherever possible by seeking alternative pest
control methods and, if they use pesticides, by educating
themselves on their safe handling, mixing, storage and application.
The PMRA promotes this approach to pesticide use as part of
its Healthy Lawns Strategy. The report also notes that children
are more susceptible to pesticides due to their behaviour
and unique physiological characteristics. The PMRA conducts
specific risk assessments for sensitive subpopulations including
children and takes their unique physiological characteristics
and behaviour into account.
A study in Quebec found traces of pesticides in the urine
of children. Was 2,4-D one of them?
Yes, 2,4-D was one of the pesticides found. The PMRA reviewed
the study conducted by the Institut national de santé publique
du Québec and found that the detected levels of phenoxy
herbicide (2,4-D) were well below the levels of concern.
It is not unusual to find a pesticide or traces of any other
environmental contaminant in tissues or fluids when an individual
has been exposed to it. However, exposure does not mean there
will be a negative health effect, particularly if the levels
are very low.
In April 2006, an article in the journal Paediatrics and
Child Health claimed that 2,4-D is the cause of cancers, neurological
impairments and reproductive problems. Is this the case?
On April 24, 2006, Paediatrics and Child Health published
an article entitled “Pesticide assessment: Protecting
public health on the home turf.” The article made a
number of claims primarily linking 2,4-D as a cause of numerous
negative health effects.
The PMRA examined the scientific information available when
determining the acceptability of using 2,4-D on lawn and turf.
The re-evaluation included a review of an extensive proprietary
database, published scientific information, foreign reviews
and any use pattern information collected by the PMRA. Based
on this information, Health Canada proposed that 2,4-D is
acceptable for use on lawns and turf when label directions
are followed. This PMRA assessment was supported by an external
expert scientific panel and the United States Environmental
Protection Agency, and was made available for public consultation.
The article also claimed the PMRA didn’t take
into account a number of epidemiology studies. Did the PMRA
examine epidemiological data when doing its review?
Yes, the PMRA examined epidemiological data in its review
of 2,4-D. Some of these studies suggested weak associations,
while others suggested no link between adverse health effects
and the use of 2,4-D. Few if any of these studies characterized
exposure in the specific context of how the product was used.
Using epidemiology studies in regulatory decision making is
challenging in the absence of a direct measure of exposure.
Epidemiology studies that identify associations between the
use of a product and a health effect are verified by conducting
a toxicological assessment to determine the actual potential
for cause and effect.
The PMRA performs these toxicity assessments to supplement
the information about associations that may be established
by epidemiology studies.
Does 2,4-D cause cancer and other illnesses?
The PMRA, as well as other international regulatory bodies,
has not concluded that 2,4-D causes adverse health effects
such as cancer, birth defects or endocrine disruption.
Before a pesticide is approved for continued registration,
it undergoes a scientific assessment to identify potential
effects including cancer, birth defects, reproductive effects
as well as prenatal and postnatal developmental effects. Epidemiology
studies are also considered as a component of the scientific
assessment.
As part of its re-evaluation of 2,4-D, the PMRA considered
the epidemiology literature. Some of this literature suggested
weak associations, while others suggested no link between
adverse health effects and the use of 2,4-D. In addition,
the Agency reviewed the extensive database of toxicology information
that specifically looked for the potential to cause adverse
effects such as cancer. The PMRA concluded that 2,4-D does
not cause cancer and it is acceptable for use by homeowners
who choose to use it on their lawns when it is used according to the
directions on the label.
These findings are consistent with other international pesticide
regulators, including the United States Environmental Protection
Agency, the European Union and those in other OECD-member
countries.
Does 2,4-D cause cancer in dogs if they walk on treated lawns?
Based on re-examination of the data, various scientists and
workgroups have concluded that there is no relationship between
2,4-D use and canine malignant lymphoma.
Although a 1991 article by the National Cancer Institute
(NCI) indicated a link between dogs with canine malignant
lymphoma and dog owners that applied 2,4-D to their lawn,
a 1991–1992 independent panel concluded that the study
design was severely flawed and, in fact, did not show an association
between the two. In 1999, scientists at Michigan State University
re-examined the National Cancer Institute’s data and
also concluded that there was no relationship between 2,4-D
use and canine malignant lymphoma.
Should I be concerned about exposure to 2,4-D from track-in
of residues into my home?
No. A risk assessment conducted for adults and children exposed
to 2,4-D while playing on recently treated turf considered
the combined oral and dermal exposure and indicated no unacceptable
risks. Therefore, as the levels of 2,4-D that have been measured
in house dust are much lower than the concentrations on recently
treated turf for which no concern was identified, the potential
exposure from 2,4-D residues inside the home is not a cause
for concern.
Should I be concerned about exposure to 2,4-D from spray
drift?
No. Risk assessments conducted for individuals applying 2,4-D
on residential turf indicated no unacceptable risks. Available
data suggest that spray drift exposure to bystanders near
the application area would be at least 100 to 1000 times less
than the exposure to applicators for whom health and safety
factors have already been considered.
For more information on pesticide spray drift, please see
the Environmental Assessment section of Re-evaluation Note
REV2006-11.
Does 2,4-D stay in the environment?
2,4-D is not considered to be persistent in the environment.
Studies from industry and from independent sources show that
2,4-D residues on turf decline quickly.
For more information on the persistence of 2,4-D in the environment,
please see the Environmental Assessment section of the Re-evaluation
Note REV2006-11.
Health Canada’s Consideration of Canadians’ Health
How are the health risks from pesticide use assessed, including
risks to children?
For an explanation of how the PMRA assesses health risks
from pesticide use, please refer to the Information Note on
Assessing Human Health Risks During Pesticide Review in Canada.
Where can I find more information on the PMRA’s
health risk assessment?
Consult the About PMRA section under Registration Process for a more detailed account of the Agency’s health risk
assessment.
Science Policy Notice SPN2002-01, Children’s Health
Priorities within the Pest Management Regulatory Agency, is
a document detailing the Agency’s commitment to protecting
children’s health.
Finally, the Science Policy Notice SPN2000-01, Decision Framework
for Risk Assessment and Risk Management in the Pest Management
Regulatory Agency, provides further details on the decision-making
process at PMRA.
2,4-D decisions in the United States
How do the USEPA and PMRA re-evaluations compare?
The approach to and outcome of the PMRA and USEPA re-evaluation
assessments are similar.
The USEPA re-evaluation released in January 2005 is its most
recent reassessment of 2,4-D. It also found 2,4-D to be acceptable
for use on lawn and turf. USEPA documents relating to 2,4-D
can be found at www.epa.gov/oppsrrd1/reregistration/24d/.
The PMRA re-evaluation of 2,4-D has been split into two parts:
review of the turf uses, which was announced in 2000, and
review of the agricultural uses, which is targeted for release
as a consultation document in late fall 2006.
General Questions about Pesticides
Several municipalities are looking at banning pesticides.
Why can they do this when the federal government allows them
to be on the market?
Pesticides must be registered before they can be imported,
manufactured, sold or used in Canada. The PMRA is responsible
for administering the Pest Control Products Act (PCPA) on
behalf of the Minister of Health. Registration under the PCPA
requires a thorough scientific evaluation to determine that
new pesticides are acceptable for a specific use and that
registered pesticides remain acceptable for use once on the
market. If Canadians choose to use pesticides, they can only
use a pesticide registered by the federal government for the
pests and treatment areas listed on the label and they must
use them according to the label directions.
The provinces and territories have the authority to enact
regulations to restrict or prohibit products that are registered
under the PCPA in their jurisdictions. These regulations can
be more restrictive than the PCPA or other federal regulations,
but cannot be less restrictive. For example, provinces and
territories may require pesticide use permits and can impose
additional use restrictions. They regulate the transportation,
sale, use, storage and disposal of pesticides; they regulate
the training, certification and licensing of pesticide applicators
and vendors; and they respond to spills or accidents.
Provincial and territorial governments may also allow cities,
towns and municipalities to enact bylaws to set further regulations
on pesticide use, including use restrictions, based on local
considerations, including use restrictions. See the Information
Note on the Role of Three Levels of Government in Pesticide
Regulation for more information.
What should homeowners do if they’re concerned
about using pesticides?
The PMRA suggests that Canadians learn about the pest they
wish to control and explore all the options available to them.
Prevention is key. Pest Notes provide information on how to
deal with common household pests. The Healthy Lawns website contains information on how people can maintain a healthy
lawn that can better resist pests, including weeds, thus reducing
reliance on pesticides.
If you decide you need to use a pesticide, make sure you
use a registered product and that you read and follow the
label directions. The label tells you how to use a product
safely. Do not use a pesticide to control a pest that is not
listed on the label. Always use pesticides for their intended
purposes. To prevent accidental poisonings, ensure that pesticides
or any other household chemicals are stored safely out of
reach of children and pets, and that pesticides are appropriately
labelled.
Are there any alternative pest control methods or products
for use on my lawn?
Pest prevention is key. One of the roles of the PMRA is to
promote Integrated Pest Management (IPM) practices, which
include a variety of methods to effectively control pests
and prevent lawn and garden infestations. Visit the Healthy
Lawns website for tips on how to maintain a healthy lawn.
The PMRA also publishes Pest
Notes that provide useful tips
on how to effectively control common household pests.
More Information on 2,4-D
When was 2,4-D first registered?
2,4-D was first registered in 1946.
Is 2,4-D Agent Orange?
No, 2,4-D is not Agent Orange. Agent Orange was a product
made for the United States military and was never registered
in Canada. Although its exact chemical composition is not
known, 2,4-D was a component of Agent Orange, along with TCDD-contaminated
2,4,5-T. TCDD is a dioxin that has been shown to cause cancer,
and 2,4,5-T is no longer on the market. With the refined manufacturing
processes that have been required by federal regulatory bodies
over the years, dioxin contamination of 2,4-D is not considered
to be a concern to health or the environment.
What is the status of the re-evaluation of agricultural uses
of 2,4-D?
The review of the agricultural uses of 2,4-D is ongoing and
is targeted for release as a consultation document in late
fall 2006.
What are label improvements?
Label improvement is an ongoing process. The language is
constantly being updated to ensure the public can easily understand
the label and to ensure the most accurate directions for safely
using the product. Pesticide labels are legal documents
with which users must comply, in accordance with the Pest
Control Products Act. They provide information to the
user on the conditions of use of a product and use rates and
use patterns (i.e., how, when and how much of the product
is applied). These directions consider the acceptable exposure
levels. They also contain many standard statements such
as instructions for disposal, etc.
In 1994, a label improvement program was implemented for
2,4-D to reduce both occupational and public exposure. It
improved label clarity, consistency and accuracy. The new
label directions include common-sense precautions such as
wearing long clothing and gloves when applying the product
and washing up when application is complete.
What is the difference between commercial and domestic class
pest control products?
Domestic Class products are sold for consumer use in and
around their home. The intent of domestic classification is
to provide consumers with products for such uses as insect
and rodent control within the home, weed control in lawns
and gardens, and swimming pool disinfection.
Commercial Class products are sold for general use in the
commercial activities listed on the label. The intent of commercial
classification is to provide operators of commercial pest
control operations, such as lawn care service providers, with
products that can be used with no health or environmental
concerns in their particular business.
About PMRA
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