July 19, 2003

**Comments sent to the EPA on human testing of pesticides.**

I am adamant that pesticides should not be tested on innocent people for
both ethical and scientific reasons.

I am Canadian but I feel that I have to comment on this issue as the
PMRA closely works with the US EPA.

First, here is my personal experience.

I have suffered accidental pesticide poisoning several times. The first
time I was aware of it, my dad had asked me to use one of these canes to
get rid of dandelions. I was 13 (1967). Of course I wore no protective
clothing but I did scrub my hands really well before supper. It did not
help. My parents found me on the hallway floor, where I had fallen after
losing consciousness. I stayed unconscious 2 or 3 days and stayed weak
for quite a while after. Before the incident, I had great vision, then
it started declining fast.

I was undoubtedly exposed many more times as my dad used quite a bit
around the house and I know I was sprayed over by crop sprayers in
Nicaragua and traveled in a car newly sprayed at every border point
across Central America. I was sick enough at that time, it was hard to
know from what\...

My downfall came after I moved to Saskatchewan, where we use 36 % of
Canadian pesticides. In retrospect, I was poisoned severely at least
twice during field work ( I am a biologist) and stayed with very
persistent \"hay fever\" and flu symptoms for weeks. I started realizing
a relationship between pesticides and health a few years later when I
felt tremendous pain in the one hand that had picked up a bottle of
fungicide on a store shelf. The acute severe pain was followed by
numbness creeping up my arm, until I realized what had happened and
washed my hands thouroughly, after which the symptoms reversed. That was
around 21 years ago. After that, I never touched the stuff again myself.
I became chemically sensitive and was close to death several times in
the early years until I learnt to appropriately deal with the illness
and developed "survival" strategies.

Starting in 1987, I had several severe reactions to unknown pesticides
but I was able to track one exposure to *Linuron*. These reactions
varied but usually included severe neuropathy and partial paralysis,
severe loss of weight, severe lung congestion relieved only by moving
out of my home during the usual *2,4-D* lawn spray spring and fall
madness. *Cygon 2E* sprayed in their yard by neighbours in an over 60
km/hour wind where it ended up drenching me in my yard caused severe
nausea and gastro-intestinal symptoms while I was nursing my son.
Thankfully, I had enough frozen breast milk that I could just throw away
3 days worth of current one...

While I am getting better at avoiding exposures by, for instance,
leaving my home without any compensation during the 2,4-D madness,
wearing rubber boots or shoes all summer because of how often sidewalks
are sprayed with RoundUP, and carrying my gas mask with me everywhere, I
still regularly get exposed and sick, but mostly not as much.

I will have you notice that all these early times I got sick, I got sick
first, then put things together later. I also was your average
unconscious person and did not expect any problem from pesticide use or
exposure.

**Here are some comments I wrote on one such human study:**

The pesticide industry financed several health effects of pesticides
trials on human beings. It is pressuring the US EPA to accept evidence
of such trials in its pesticide licensing and reevaluation decisions,
even though they may be scientifically invalid, as well as totally
unethical.

For instance, Bayer\'s *azinphos methyl* study was **scientifically
invalid** because:

\* It tested only eight adult males, whereas a test of more than 2,500
people is needed to yield statistically valid results for certain
effects; \[but then, of course, you usually determine NOELs (No Adverse
Effect Level) on no more animals than that, correct?\]

\* What NOEL? In my recent research on malathion, I am finding NOELs for
all kinds of things: oral, inhalation, and dermal exposure, cancer,
genotoxicity, birth defects, neurotoxity and, in the case on inhalation
exposure to malathion, I find in your own EPA documents that there is no
NOEL determined yet for severe lesions of the respiratory system as they
occurred at all levels of exposure!

\* Regulatory agencies still have so many holes to plug in your risk
assessments such as developmental toxicology studies (only 9 of your
over 140 identified pesticides have that info yet), low level and
endocrine-effects studies for which there are not yet any guidelines,
that what would one NOEL for one condition mean for human safety anyhow?

\* Let's face it, most of us would not think of swallowing large doses
of pesticides. Most of us are exposed through inhalation, at low dose,
and most unwillingly and unknowingly, and so is the rest of the
environment. How relevant is an high or medium dose ingestion study
anyways? The inhalation toxicity of pesticides is often increased by
inhalation ( 20 times for malathion) and yet these are the hardest NOELs
to find...

\* It did not yield results relevant to children or women, or unhealthy
people of all ages;

\*It did not account for "in-species" natural genetic variation in
susceptibility which has apparently been observed to be up to 10,000
times for at least some factors, or for synergistic effects with other
pesticides, drugs or pollutant, such as when a needed detoxification
enzyme is already busy detoxifying something else, therefore
significantly increasing the toxicity of a pesticide.

\* In this particular study, I understand there **were at least 67
\"adverse events,\" including symptoms often associated with
organophosphate poisoning;** all eight dosed subjects suffered from such
\"events\" (including chronic headaches, nausea, abdominal pain, etc.).
However**, all \"events\" were attributed, without detailed medical
explanation, to a \"virus\" or the \"ward environment**,\" even though
most of these events occurred in the dosed group, and two of the placebo
subjects suffered no such events.

**Basically, there are so many "spin" ways to invalidate such a study,
from the choice of subjects to limiting what effects you look for, to
interpretation of results, that I don't see that it would have any
validity. I would trust it a lot more if don by truly independent
scientists, instead of industry-paid ones.**

Bayer conducted the study to try to establish a less protective *no
adverse effects* level (NOEL)."

The unscientific unwarranted conclusion to such a study is that at the
level of exposure tested, there were no effects of the pesticide. The
only science I see here is the one of falsification to the point of
ridicule.

If ever the PMRA or the US EPA accept such studies in their pesticide
evaluations, as far as I am concerned, you lose the last shred of your
credibility! You won't pass the laugh test!

Other issues that will have to be dealt with are those of **exposure and
drift**. The following will likely help explain why there are so many
cases of pesticide poisonings even when used according to label
instructions. According to the recent report *Secondhand pesticides*, by
Californians for Pesticide Reform, when levels of several volatile
pesticides were **appropriately** **measured** ( with aerosol samplers)
both close and further away (in some towns), the Hazard Quotient for
several exceeded many times (over 100 times for chlorpyrifos) the level
deemed "acceptable' by EPA. How good is any NOEL if there is no way of
ensuring that people are not exposed to levels higher than what is
deemed safe?

My recent review of Malathion air concentrations during and after ULV
spraying came up with a lot of really bad science, such as measuring
concentrations and drift of an aerosol with an average diameter of 15 um
with filter paper or cards on which other studies showed that the
smallest diameter deposited was 50 um and measured 4.4 times less
colonies on cards than aerosol. The Canadian recommended spraying rates
are all based on assumptions and modeling and absolutely no
measurements. ( I have correspondence to show that). According to their
own ssumed air concentrations, the hazard quotient as measured in
Secondhand pesticides would exceed the levels deemed acceptable by a
minimum of 12 times...A NOAEL is the basis for all risk evaluation
calculations, but what good is it when air measurements concentrations
are missing or normally exceed the level determined acceptable with
current and normal use?

Here is essentially what one recent ULV Bti study has shown:

**Aerosol spray moves a lot, is small enough to be breathable, and
staying indoors offer little protection:** One Canadian study (1)
measured indoor and outdoor numbers of live colonies of Btk in Victoria
during the Gypsy Moth Spray Program. They measured with the usual cards
(Kromecote) traditionally used to measure drift and, at the same
location, with an aerosol sampler. What they found is worth thinking
about. While the ULV spraying was aiming for a target droplet size of
125 um,

a\. the only droplets found on the drift (Kromecote) cards were between
50 -- 150 um in size

b\. **the droplet size was a lot smaller than planned**, averaging
4.3-7.3 um in the aerosol measured, within breathable range, and able to
reach the small airways of the respiratory tract.

c\. **drift outside the area**: even when the Kromecote cards showed no
drift, aerosol was still measured in most cases. There was no
correlation between the bacterial concentration and distance, i.e. there
were just as many bacteria 1000 meters away as close to the sprayed
area; the Btk geometric mean Btk concentrations of adjacent zones was
often twice the one of inside the spray zone during spraying.

d\. on average, the Kromecote card sample concentrations were 4.4 times
lower than aerosol sampling

e\. **Staying indoors does not offer much protection**: the
concentrations indoors started approaching the outdoor concentrations
after 2-3 hours, reached 1/3 of original outdoor concentration after 5-6
hours and, at that time, exceeded outdoor concentrations. Indoor
concentrations had no correlation with any of the measured
characteristics of the indoor environment, or whether doors and windows
were open or shut. (1)

Regulatory agencies need to redefine drift to include evaporative drift
and demand proper aerosol measurements for all studies before any of
your calculations are valid.

1.  Kay Teschke et al; **Spatial and Temporal distribution of Airborne
    *Bacillus thuringensis* var *kurstaki* during an Aerial Spray
    Program for Gypsy Moth Eradication;** environmental Health
    Perspectives, vol 101/no 1/Jan 2001, p. 47-54

I just wrote a paper reviewing, among other topics, the "missing parts"
of the regulatory process, mostly PMRA but also EPA. These are some
exerpts:

**Inherent assumptions of the regulatory system**

Existing Acts and regulations a priori assume that dangerous pesticides
can be managed with negligible impact on health. Health experts think,
however, that given current acute and chronic pesticide-illness data,
continued increase in use of many hazardous pesticides, and persistence
of these toxins in air and water, such faith appears unfounded. The rule
is still that chemicals are recognized as harmful long after their use
has become routine, and exposures have become widespread (mercury, lead,
PCBs, alcohol, nicotine, DDT, chlorpyrifos, CCA treated wood)

**These are the [*[disproved]{.underline}* assumptions]{.mark} under
which the Canadian Regulatory System (PMRA) functions: (as well as the
US legislation)**

\- that "the dose makes the poison", ( not exclusively true e.g.
endocrine and low level effects)

\- that high dose studies show all the potential health effects

\- that there is a threshold below which there are no effect (NOAEL)

\- that there is an immediate cause and effect

\- that pesticide exposures occur one pesticide at a time, with no
interaction with any other substance ( NOELS established on individual
chemicals, right? Not even on common formulations the public may be
exposed to)

\- that present studies requested for registration are sensitive enough
to identify functional problems

\- that a new safety factor of 1000 (compared to 100 before) will
account for most of human variability as well as children's special
vulnerability

\- acting as if all the data and studies (nervous, immune, hormonal
system, developmental nervous, immune and hormonal systems) have been
performed for all registered pesticides.

\- that pesticide exposures are quickly over and do not accumulate in
the body (except for organochlorines like DDT)

\- that because something is written on a label, it means the
instructions or precautions will be followed.

\- it assumes that all formulants not listed by EPA are safe and do not
have to be disclosed

\- and, finally, that regulating pesticides will decrease risk and use.

These assumptions are still underlying C-8, the new Canadian Pest
Control Products Act (PCPA 2002). They have all been disproved.

**Slow response**

Any regulatory system is slow to respond. When a problem is identified,
it takes years to determine needed new studies (appropriate studies for
regulatory purposes still have to be defined in several fields such as
hormone-disrupting and low-dose studies), years more for industry to
carry them and submit the results, and years more before these are
evaluated. *During all this time, there is nothing in PMRA' s or EPA's
information on approved pesticides indicating what needed studies have
not yet been submitted or have been waved for a particular product to
meet new guidelines* (e.g. no immune, hormone-disrupting or
developmental neurotoxicology studies submitted). When uses are
cancelled or labels have to be changed to new "safer" tolerance levels,
the changes cannot become legal until companies have effected the label
change, which can take from 1 to 4 years.

How can anyone say a particular product is safe when there are so many
studies missing for each? Or that it is safe after a use is cancelled or
a label changed, when pesticide products keep on being sold for up to
several years for uses judged inappropriate, and with inappropriate
labels.

What does a NOEL based on 8 unrepresentative people prove anayway?

**Outdated and Costly**

However, even the best regulatory systems are always outdated. The more
measures, the more tests, the more the cost increases. In 1971, the
total U.S. expenditures on pesticide regulation and management of
pesticide risk was 4.8% of sales, 11.4% in 1996, and estimated at 16% in
2020, assuming no public concern change in priorities and, so far, no
reduction in risk. By comparison, assuming a national U.S. commitment to
*bio-intensive* Integrated Pest Management (IPM) by 1996 would decrease
these total expenditures in 2020 by 20%, with an estimated 75% reduction
in overall risks. **The only full-proof way to decrease both risk and
costs of pesticides is pesticide reduction.** (Pesticides at the
Crossroads, Consumer Union, 1996)

**Conclusion**

Furthermore, present regulations have not ensured or brought about any
global reduction in reliance on pesticides and pesticide use. Because
pesticide use is still increasing, and the aggregate public health
hazards from pesticides have not decreased since 1970 while the costs of
pesticide regulation consistently increase, the only way to decrease
both risks and costs is by an aggressive government policy of reduction
in pesticide use, and development of alternatives to pesticides.

Many thousands of people are sickened every year from pesticide
exposure, in spite of NOELs and your "on paper" risk assessment
calculations and models, likely because they are so far behind the
times.

**[Final conclusion]{.underline}**

MY suggestion is that, to have any social justice, people who promote
pesticide use and believe in them and their safety should be willing to
provide their own bodies and the ones of their families, including
pregnant women, to prove beyond doubt that there are no concerns with
pesticide use. After all, the study would not even have to consider a
placebo effect as none of them believe in it.

Even if such a study discounted all "negative events", as the azinphos
methyl one did, it would still use a pure product and not the
formulations the public is exposed to, and could never conclude the
pesticide tested is safe. All it could say is that with that group at
that level of exposure, no significant effect has been recorded.

Unfortunately, there is no social justice in this regards and all of us
have been and are guinea pigs, or rats if you prefer, in a world wide,
totally unregulated and unmonitored experiment. Now, industry wants to
purposefully use people as guinea pigs... If you allow then to use
"healthy" university students, will they stop there? How about
purposefully using pregnant women to test developmental toxicity?

We all need to get off the pesticide band wagon. The EPA has done great
work in its web site and information on pesticide alternatives in
school. It should pursue this approach across the board and have its
mandate changed to be one mainly of support of non-toxic alternatives
techniques and products and safer pesticides and ban the rest, and the
world will be a safer place**.**

Thank you,

Paule Hjertaas, B.Sc Biology

15 Olson Place,

Regina, Sask,

S4S 2J6