Sludge Watch ==> Drugs, Environment and our Health - Excellent Review Policy Paper

[Maureen Reilly]

Sludgewatch Admin:

Excellent paper...Canadian and US policy approaches discussed..impact of 
drugs in wastewater..and how they are recycled into our drinking water and 
food.

..................................................

http://whp-apsf.ca/en/documents/fullCircle.html

Full Circle: Drugs, the Environment and Our Health
By Sharon Batt, for Women and Health Protection 1



INTRODUCTION

Since the mid-1990s, news headlines about “drugs in the water” have alerted 
the public to an unsettling public health risk.2 Trace amounts of 
pharmaceuticals have been detected in Canada’s lakes, rivers, streams and 
tap water. Other chemicals from food and drug products -- including food 
additives and the ingredients of toiletries -- have also been detected, as 
have veterinary and agricultural chemicals. New biologics, genetic therapies 
and genetically modified foods are more recent-comers that could end up in 
this “chemical soup”. The health impacts on humans are not known, but 
deformities in the reproductive systems of marine life show that some 
chemicals contaminating the environment are not benign, despite the very low 
concentrations that have been detected3.

Such findings show that we need to rethink our relationship to 
pharmaceutical drugs and other personal care products. Taking a drug is not 
simply a personal decision that affects one individual’s health. Drugs alter 
the ecosystem on which all living things depend. And, far from vanishing 
into the environment after use, these substances may travel full circle – 
into lakes and streams, and back into our bodies, via the water we drink and 
the food we eat.

This discussion paper looks at this neglected form of environmental 
contamination from a public health perspective, with particular attention to 
women’s health. The analysis evaluates the Environmental Assessments 
Regulations Project (EARP), a federal government project designed to protect 
the health of Canadians and the Canadian ecosystem from pharmaceutical and 
personal care products (PPCPs4). Women are the majority purchasers of many 
PPCPs, including drugs, foods, cosmetics and personal hygiene items. Within 
the family, women often buy these products, oversee their use and take 
responsibility for their disposal. To change patterns of purchase, use and 
disposal, women need to be fully engaged in policy discussions, 
decision-making and implementation.

This paper argues that the most health-promoting, cost-effective strategy 
for everyone is prevention: reducing inappropriate use, over-use and abuse 
are strategies that would improve health and mortality while also saving 
money. Similarly, reducing the vast quantity of unused drugs and disposing 
of any unavoidable excess safely is more ecological and economical than 
trying to filter them from the water after the fact. These “upstream” 
approaches also have the advantage that they can be implemented almost 
immediately. Other approaches, such as improved filter systems and 
redesigned products, will take time and resources. Programs should be 
prioritized according to criteria such as product toxicity, importance and 
affordability.

In September 2001, Health Canada launched the Environmental Assessment 
Regulations Project (EARP), under the auspices of its Office of Regulatory 
and International Affairs5. Designed to address the health and environmental 
effects of PPCPs, the program has three parts: 1) regulations to protect the 
environment from PPCPs; 2) a scientific research program; and 3) best 
practices and public education programs. 6

EAR Project documentation suggests a vision which meets many of the criteria 
for a model public health initiative. The project is to interpret health 
protection broadly, including harmful effects on the environment or its 
biological diversity, as well as direct human health impacts.7 The proposed 
decision-making strategy will incorporate the precautionary principle, which 
means protective action can be taken before harm has been demonstrated with 
scientific certainty.8 Prevention is to take precedence over mop-up, 
“avoiding the creation of pollutants rather than trying to manage them after 
they have been created.”9A commitment to open discussion invites the 
public’s participation in solving the problem.10

To date, much of the government’s work falls short of these ideals. Smiling 
faces of Canadians adorn EARP documents, yet the program lacks a “big 
picture” vision that would engage the public and put the components in 
perspective. A key discussion paper closes non-specialists out of the 
dialogue with technical language and a legalistic emphasis on a regulatory 
framework11. The proposed scientific program is narrowly toxicological, 
aimed at measuring substances and their effects, rather than preventing them 
from entering the environment.12 The highly technical research agenda also 
limits opportunities for public participation. The public consultation 
process has been dominated by the pharmaceutical and biotech industries, a 
fact reflected in the concerns stakeholders most often expressed: that the 
regulations will slow down the introduction of new substances onto the 
Canadian market and affect international trade.13 The adequacy of the 
proposed regulations for health and environmental protection – ostensibly 
the purpose of the exercise -- were not even mentioned.



The Problem in Context
Although policy initiatives in this area are recent, pharmaceuticals have 
very likely been present in the environment as long as they have been 
commercially marketed.14 The bellweather scientific study appeared in the 
literature in 1976, documenting pharmaceutical drugs in Kansas City sewage. 
Little notice was taken for 15 years when researchers studying aquatic 
contaminants accidentally discovered the cholesterol-reducing drug clofibric 
acid in Germany. More research in Europe detected clofibric acid in major 
waterways throughout Europe and in Berlin’s tap water.15 Tests in Canada and 
the US have shown that North American waterways contain traces of 
antibiotics, painkillers, anti-inflammatories, hormones, tranquilizers, 
chemotherapy drugs and drugs used to treat epilepsy and blood cholesterol. 
Trace amounts of drugs have been found in tap water of some Canadian 
communities.

As consumers, we excrete PPCPs into sewers; we flush unused medications down 
the toilet or sink, and we rinse soaps, shampoos and cosmetics down the 
drain when we bathe. Even posthumously, the drugs administered in the home 
stretch of our lives likely leach into cemeteries and groundwater16. 
Consumer use may account for the majority of trace pollutants in the 
environment although the available information is insufficient to prioritize 
sources.17 Other contributors are hospitals and long-term care facilities, 
veterinary drugs (including large amounts of antibiotics), drug-contaminated 
sewage sludge sold as farm fertilizer, and industrial waste disposal at 
plant sites.

The concentrations detected in water are typically between 20 parts per 
billion (ppb) and less than one part per trillion (ppt); however, drugs are 
designed to have an effect in small quantities. Chronic exposure to low 
levels of multiple bioactive substances may well have a deleterious effect 
on some organisms.18 Some drugs (e.g., anti-epileptics) are persistent; 
others are “pseudo-persistent” -- they break down but are continually 
replaced by widespread use.19 Some drug compounds dissolve in water but 
about 30 per cent dissolve only in fat, which enables them to enter cells 
and move up food chains becoming more concentrated. The risks to both 
aquatic organisms and to humans are largely unknown but could include 
resistance to antibiotics and the disruption of endocrine systems.



A Women's Perspective on Health Products and Environmental Pollution
Ecosystem contamination with PPCPs has the potential to affect flora and 
fauna, fish and fowl, women and men. Women have a particular relationship to 
PPCPs, however. Effective policies designed to reverse this form of 
pollution need to consider differences between the sexes, both cultural 
(gender) and biological.

Gender Affects Purchase, Use and Disposal.

Because of cultural influences, women are the family members most often 
responsible for health, including purchase of drugs and food, food 
preparation, caring for sick family members and disposal of home-use 
products. Many drugs are gender-specific (e.g., birth control, menopausal 
hormone therapy), or are prescribed more often to women than to men (e.g., 
anti-depressants). Drug advertising, whether aimed at consumers or 
physicians, frequently plays on women’s insecurities about weight, pimples, 
wrinkles, stress, bone loss and loss of cognitive powers in old age. 
Pharmaceutical companies also target women to expand the use of existing 
drugs and extend patent life, as in the promotion of anti-depressants for 
“mood disorders”. Many of these prescribing patterns reflect the unnecessary 
medicalization of women’s lives, that is, the prescribing of drugs to 
“treat” such healthy life stages as menstruation, pregnancy and menopause.20

Women are also the main users of cosmetics, perfumes and hair products, many 
of which have been found to contain phthalates, a family of industrial 
chemicals linked in animal studies to permanent birth defects in the male 
reproductive system.21 Some phthalates have been detected in drinking water, 
as have synthetic musk fragrances from perfumes and other toiletries.22

A study commissioned by Health Canada found that women were more interested 
than men in learning about safe disposal of drugs and were more likely to 
state they would act on such information, even if it were inconvenient. 
Women were also more likely than men to state that they flushed unwanted 
drugs down the toilet or sink.23 Strategies to reduce use of particular 
drugs will only be effective if they recognize the gender dynamics 
underlying drug promotion and drug use.

Gender and Demographics. Women predominate in two demographic categories for 
which PPCP use may have a particular impact: the elderly and the poor. 
Elderly women comprise a large and growing segment of the population. The 
elderly ingest more drugs than the young, and use them more often. Geriatric 
medicine has been shown to result in particularly high wastage, for a number 
of reasons, including frequent physician alterations in dosage and 
prescribing new drugs, patient improvement, “silent symptoms” that provide 
the patient with no incentive for continuing medication, and patient death. 
Many geriatric drugs have been found in environmental monitoring studies.24 
Older women have had more years to absorb bio-accumulative drugs from the 
environment and reduced immunity could make them more sensitive to some 
effects of environmental chemicals in the water. For all these reasons, 
research, education and policies related to drugs in the environment must 
include elderly women.

At any age, women are more likely than men to be poor. The poor are less 
able to afford technical solutions, such as home filter systems or 
re-designed, environmentally “clean” drugs. Research and policies must 
recognize that corrective programs could widen class-based health 
disparities.

Gender and Values.

As a group, women are more willing to go out of their way to protect human 
health and the environment.25 The women’s health movement and the 
ecofeminist movement focus on health protection and environmental protection 
respectively. The survey conducted as part of EARP (and cited above) 
captures this gender gap in values. Women were more likely than men to say 
they were interested in learning “all I can” about how to safely dispose of 
household products so they don’t harm the environment (74% versus 66%); and 
women were more likely to say they would dispose safely of household 
products “all the time, even if it’s inconvenient” (70% versus 62%).26 This 
commitment to health and the environment makes women key players in programs 
for change. The gender values gap must also be considered when framing 
value-laden policies, such as risk assessment and the precautionary 
principle. More men hold decision-making positions in industry and 
government while more women are poor and have little political power. Whose 
values will prevail in deciding what level of risk is acceptable to a 
community? Who decides when scientific evidence is sufficient to trigger the 
precautionary principle (see below, p 21)?

Biological Differences between the Sexes .

Biologically, women have different vulnerabilities to chemicals than men at 
certain points in the life cycle. Pregnancy is the most obvious example. The 
DES and thalidomide tragedies shattered the long-held rule of toxicology 
that “the dose makes the poison”. Minute quantities of a drug taken by a 
pregnant woman at a particular stage in fetal development can cause 
deformities, cancer and subtle cognitive effects. DES is now recognized as a 
member of a class of chemicals that disrupt the endocrine (hormonal) system. 
Some specialists believe no dose of synthetic hormones is safe for the 
developing embryo and fetus.27

Chemical contamination of breast milk is another women’s health issue linked 
to environmental contamination. Aromatic amines -- used to make 
pharmaceuticals, dyes, plastic foams, and pesticides -- have been detected 
in human milk and are known to cause cancer in mammary rat tissue.28

Pregnancy and lactation are not the only windows of vulnerability in a 
woman’s life cycle. Puberty, menstruation, and menopause are all the result 
of hormonal fluctuations.

The cells in women’s breasts appear to reach full maturity only at a first 
full-term pregnancy, when they become more resistant to cancer-causing 
chemicals and radiation. Women of any age who have not had children may 
therefore have increased susceptibility to carcinogenic chemicals in the 
environment than women of the same age and health status who have had 
children. Furthermore, women have more fatty tissue, on average, than men so 
store more endocrine disruptors in their bodies. Women have adverse 
reactions to drugs more often. This difference is only in part because women 
use more drugs than men. A report by the US General Accounting Office 
concludes, “Greater health risks for women may be due to physiological 
differences that make women differentially more susceptible to some 
drug-related health risks.”29

Health protection policies should be designed to protect the most vulnerable 
members of society. We can only be certain regulatory standards, and 
research designed to establish regulations, will adequately protect women if 
a gender analysis is built into research programs and policies.30 Despite 
the evidence of the particular damage chemicals can have on women’s health, 
safety standards for chemicals have often been based on healthy white adult 
males. Research on male animal models, and on men, is easier to conduct 
precisely because researchers do not have to contend with the hormonal 
fluctuations of monthly cycles, pregnancy, and menopause – the very systems 
affected by endocrine disruptors.

Organizations working to promote access to clean water in the developing 
world have begun to analyse this issue from the perspective of gender 
equity.31 While poverty and health problems in the developing world differ 
in many respects from those in wealthy countries, similarities exist. In a 
report titled Untapped Connections, the Women's Environmental & Development 
Organization (WEDO) advocates for "a gender perspective in all water related 
policies” (p 2). WEDO also stresses that government commitments to health 
and gender equity rely on "a better
understanding of the different roles and responsibilities women and men have 
in water access and use; health, sanitation and hygiene; environmental 
health and ecosystem stability; and public versus private services" (p. 3). 
These principles can form the basis of a global strategy to protect water 
resources while promoting human rights.

Concerns about “EARP”
As of this writing, the Canadian government’s program has highlighted 
toxicological research, regulatory change and meetings with industry 
stakeholders about potential trade impacts. Discussions with public interest 
groups, including environmental, women’s health and consumer groups, have 
been limited. EARP’s narrow focus overlooks strategies for short-term action 
and offers little to promote a truly preventive strategy that puts health 
and environmental protection above trade and economic objectives.

A striking contrast to the government’s approach is the Green Pharmacy 
Stewardship Program proposed by Christian Daughton, a scientist at the US 
Environmental Protection Agency. Daughton envisions a broad, holistic 
program jointly overseen by the healthcare industry and consumers. Three 
goals shape the Green Pharmacy concept: protect the environment, reduce 
medical expense for the consumer and improve patient and consumer health.32 
The analysis that follows uses selected highlights from Green Pharmacy 
documents to illuminate components of EARP.



Environmental Assessment Regulations
The government’s environmental assessment regulations and industry 
consultations are intended to overcome a policy gap between the Health and 
Environment ministries. Drug safety assessments, which Health Canada carries 
out under Food and Drugs Act (F&DA) regulations, currently evaluate safety 
only for substances consumed directly. The assessments have not been 
concerned with protecting the environment or with human health problems 
arising from environmental contamination by PPCPs The Canadian Environmental 
Protection Act (CEPA), the regulatory framework designed to protect Canada’s 
environment, came into force in 1988 and was revised in 1999. When CEPA was 
enacted, according to a federal government Powerpoint presentation on EAR, 
both Health Canada and Environment Canada felt, incorrectly, that the 
substances regulated under Canada’s Food and Drugs Act were exempt from 
CEPA. 33 Proposed new regulations will bring food and drug manufacturers, 
and Health Canada’s review processes, in line with the requirements of CEPA.

When the regulations take effect, they will extend the information and 
reporting steps required for Health Canada’s product approval process to 
include environmental concerns. 34 As with current reviews, manufacturers 
will provide data for the government’s assessment. Once the regulations are 
in place, products that came to market between 1987 and September 2001 will 
be assessed to see if they are deemed safe for the ecosystem and/or human 
health through environmental exposures. If they are not, EAR publicity 
states: “immediate and appropriate action will be taken.”35

In previous documents, Women and Health Protection expresses concerns about 
Health Canada’s drug review processes, including government-industry 
conflicts-of-interest, the worrisome move towards fast-tracking of drugs, 
excessive secrecy in decision-making, lack of public consultation and 
evidence that Canada’s trade objectives often override health protection 
concerns.36 As an extension of Health Canada’s drug review process, EARP 
seems destined to inherit these systemic problems. EARP is guided by a 
regulatory approach designed to promote economic growth by increasing 
Canada’s international trade competitiveness. This strategy includes the 
federal government’s “smart regulations” which are intended to “contribute 
to innovation and economic growth and to reduce the administrative burden on 
business.”37 The smart regulations strategy involves international 
collaboration and harmonisation of regulations with those of Canada’s 
trading partners. A paper published by Women and Health Protection 
critically evaluates the international harmonisation process from the 
perspective of women’s health. 38 The Canadian Biotechnology Strategy, which 
promotes a favourable climate for investment, development and innovation, is 
also integral to EAR.39 Feminist academics, health care activists and 
environmentalists have critiqued the market-driven, medicalized view of 
health inherent in the Canadian Biotechnology Strategy.40

As stated in the EAR background documentation, “The F& DA was designed [in 
1954] as a consumer protection statute dealing with health and safety and 
economic fraud in respect of food and drug products.”41: The Act was not 
meant to promote industrial development: with commercial objectives embedded 
in the EAR framework, however, trade and economic development priorities 
could easily override concerns about human health, the environment and false 
product claims. Input of those free of industry conflicts-of-interest is of 
paramount importance.

The regulatory emphasis on toxicology in the government’s initiative is also 
problematic. Daughton, in his Green Pharmacy proposal, questions how useful 
such regulations can be in controlling PPCPs in the environment. He notes 
the pitfalls of trying to track and regulate potential chemical stressors 
given that “The spectrum of pollutants typically identified in an 
environmental sample represent but an unknown portion of those actually 
present (possibly very small), and they are of unknown overall risk 
significance.”42 Daughton also argues that the traditional 
chemical-by-chemical approach to pollutant tracking and regulation needs to 
give way to an approach based on probable cumulative exposure, 
“understanding the ramifications of entire classes [of chemicals] that share 
a common mechanism of action” or a common physiological or behavioral 
endpoint.43 He notes that any approach that uses “predicted” environmental 
concentrations fails to account for three major factors: geographic 
variability in drug usage, sources other than legal sales (e.g., physician 
samples, black market sales and “prescription drug patient assistance 
programs”), and interactions between chemical stressors.44 EARP’s focus on 
regulating and testing specific drug and food products for toxicity could 
serve mainly to postpone action by deflecting attention and resources from 
more promising initiatives.

EARP materials do not mention other regulatory tools at the government’s 
disposal. These tools include strengthening the drug approval system by only 
allowing new drugs on the market that show an advantage over existing 
treatments, tightening and enforcing the ban on direct-to-consumer 
advertising, directly regulating the promotion of drugs to physicians, 
opening the drug approval process to public scrutiny, improving 
post-marketing drug surveillance, and adopting a more stringent 
interpretation of the precautionary principle. Many of these approaches 
would help curtail the medicalization of women’s health. The government 
needs to revisit its initiative with a broader regulatory vision in mind.



Science and Research
A second key component of EARP is its national science agenda. The 
government’s research priorities are tied to its regulatory agenda; in other 
words, the research agenda is toxicological. This focus is reflected in the 
objectives of a workshop that Health Canada and Environment Canada sponsored 
in February 2002 to discuss Pharmaceuticals and Personal Care Products in 
the Canadian environment. The workshop’s main objectives included, 
“identifying major scientific knowledge gaps and establishing risk 
assessment and risk management needs in Canada.”45 Predictably, research 
priorities identified by workshop participants reflected the pre-set agenda 
(e.g., obtain scientific data on exposure and effects of PPCPs in the 
Canadian environment; foster development of a Canadian regulatory framework 
in harmonization with international organizations).46

At best, toxicological assessment research is long term. Making it the 
centerpiece of the science agenda for PPCPs in the environment excludes or 
marginalizes other, equally important scientific research that would support 
immediate and medium-term action. Daughton notes the well-documented fact 
that poverty and malnutrition contribute far more to ill health than lack of 
medication.47 Curtailing some uses of medication can improve health 
outcomes. He proposes, instead of narrow technical objectives, a health 
promotion framework in which industries and the public would be encouraged 
to develop a consensus and cultural mindset toward “holistic environmental 
responsibility”. A multidisciplinary approach would expand the scientific 
agenda beyond analytic chemistry.48 A cohesive, scientifically sound set of 
principles would guide changes to packaging, distribution, and purveyance of 
PPCPs, many of which could be implemented rapidly.49 Examples include 
lowered dosing based on studies showing that effective doses of some drugs 
can be lower than previously realized. Cutting doses could reduce adverse 
drug reactions, including deaths, while minimizing the potential for 
environmental effects.50 A survey of drug disposal in Ontario estimated the 
annual cost of wasted medication in the province at over Can$40 million. 
Much of the waste was in the elderly population, which is predominantly 
female.51 Other research has shown that shelf lives for some drug 
formulations exceed the duration indicated by the expiry dates (under ideal 
storage conditions), providing the basis for substantial savings without 
compromising health.52 The same science-based principles would guide 
consumer actions. “Some of these actions would require little further 
research, some would demand attention to the patchwork of laws and 
regulations concerning drug recycling and disposal; others would require 
further research,” says Daughton. (It should be noted that Daughton 
emphasizes the advantage of voluntary initiatives, by both industry and 
consumers. While some voluntary programs may be effective, I believe many 
goals will only be achieved with regulations; but these regulations must go 
beyond toxicological risk assessment).

Substituting complementary and alternative medicine (CAM) approaches for 
conventional pharmaceutical interventions, and replacement of synthetic 
ingredients in personal care products with others made of naturally 
occurring substances, could have considerable impact, according to Dr. 
Warren Bell53.  “Many CAM interventions have no effect on the ecosystem 
(e.g. manual therapies, body/mind therapies); others have minimal effects 
(e.g. homeopathy, lifestyle alterations). Many others probably have limited 
effects, or a least involve simple redistribution of known components of the 
biosphere (e.g. plant remedies, Epsom salts compresses, vitamin and mineral 
supplementation and therapy), often themselves considered to be broadly 
beneficial or at least neutral in effect,” says Dr. Bell. Awareness of the 
environmental impacts of synthetic PPCPs could be the impetus for 
investigating the therapeutic and environmental impacts of CAM remedies (and 
some, particularly herbal remedies and nutritional supplements, are highly 
bioactive54).

This brief assessment only hints at the breadth of research that could be 
pursued under a refocused program within a broad, health promotion and 
ecological framework.55



Public Education
The third prong of the EAR Program comprises public education and public 
participation initiatives.56 The EAR Project Benchmark Survey, conducted for 
Health Canada in 2002, suggests that household disposal will be a focus of 
the Project’s educational efforts. The survey assessed consumer attitudes to 
waste disposal, including the disposal of pharmaceuticals, and other PPCPs. 
Currently, British Columbia, Alberta and Saskatchewan have provincial 
take-back programs for unused drugs57, but these are not well promoted and a 
patchwork of provincial waste-removal practices has stalled a national 
take-back program.

While household disposal practices are an obvious target for change, this is 
not primary prevention -- a stated goal of EARP. Educational programs to 
instill Best Practices need to actively promote reduced use of PPCPs. 58 A 
more visionary program, like the Green Pharmacy, could capture the public’s 
imagination and encourage participation in a broad program of reduced use.

Post-Walkerton, the Canadian public cares deeply about water and understands 
that safe water is fundamental to good health. Media coverage has created a 
“teachable moment,” in which the public is receptive to understanding the 
issues and eager to help find solutions.59 The specter of contaminated water 
can be frightening, instilling a sense of helplessness over shrinking 
resources necessary to life. Much thought needs to be given to the framing 
of educational messages and programs so that risks are neither downplayed 
nor sensationalized.

A great deal can be done immediately and in the short term. Some drug use is 
necessary to good health, but much is inappropriate and causes harm. 
Corporate practices designed to promote drug use that is not scientifically 
based need to be curtailed. Examples are direct to consumer advertising60, 
and commercially sponsored seminars to encourage off-label prescribing. 
Educational efforts to promote health maintenance through better nutrition 
could be stepped up61. Educational programs recognizing women’s role as 
family educators and gatekeepers for PPCPs might be highly effective in 
reducing drug use. Women are familiar with medicalization issues, through 
experiences with drugs like HRT, and place a high value on health and the 
environment; a science-based program to improve their family’s health while 
saving money and protecting the environment could have rapid results.

Educating the public about PPCPs in the drinking water presents some of the 
same difficulties as educating nursing mothers about chemical contaminants 
in breast milk. Apprehension about drugs and other chemicals in the water 
could drive people to avoid their necessary intake of water, or to purchase 
expensive home filtering systems and bottled water, which may be no less 
contaminated. Penny Van Esterik, in an analysis of communicating risks about 
infant feeding, notes the importance of placing the issue in a broad 
environmental health context, so that the goal is reducing pollution, rather 
than avoiding breastfeeding.62 Public education about drugs in the water 
requires a similarly broad focus. Questions for public debate include: What 
is the full range of remedies? What solutions will be emphasized? When 
parties disagree, who decides?



Public Participation and the EAR Consultation Process
Beginning with the Notice of Intent, Health Canada has stated its commitment 
to a process of consultations with stakeholders in the development of these 
new regulations. To date, this process has included meetings to explain EAR 
to government employees, industry stakeholders, and members of 
non-governmental organizations concerned about health and the environment. A 
“benchmark” survey of 1,512 Canadians was conducted to determine prevalent 
attitudes and product disposal habits. Passive methods of communication with 
the public include a website, newsletters and an information line to 
disseminate information and register reactions.

Despite the stated commitment to public participation in EARP, the 
consultations have been geared to industry players and have failed to engage 
the public or non-governmental organizations (NGOs). Rather than enlisting 
the public as full partners in debating the “big picture”, discussions with 
the public have been narrowly focused on the proposed regulations.

The main vehicle to engage the public in the EAR process involved 
stakeholder groups. In May 2002, 16 NGOs from across the country accepted an 
invitation to attend a one-day Health Canada workshop on EAR. At an EARP 
multi-stakeholder meeting in February 2003, NGO participation had dwindled 
to four (plus three representatives from the Public Advisory Committee, a 
government-appointed consumer panel that advises the Health Products and 
Food Branch). The government and industry representatives numbered about 70, 
from the federal departments of Environment and Health and from major 
pharmaceutical and biotech companies. The agenda at these meetings was 
pre-set, with Powerpoint presentations and guided discussion of the Issue 
Identification “workbook” on the regulatory proposals. At both meetings, the 
opaque language of risk assessment and regulation set up barriers to NGO 
participation by framing the problem and the process in terms meaningful to 
industry and government.

The issues inherent in EAR are challenging for NGOs. Historically, research, 
regulations and policies for health and the environment have evolved in 
separate silos; similarly, most NGOs have taken on either health or 
environmental issues, but not both. Some exceptions are WHEN (Women’s 
Healthy Environment Network), the Canadian Coalition for Green Health Care, 
and (in the US) Health Care Without Harm.63 Most NGOs need additional 
resources if they are to extend their expertise to include the interaction 
between health and the environment.

If health and environmental protection are to take precedence over trade 
issues, the participation of health and environmental advocacy groups is 
vital. For NGOs working with tight budgets and staff cutbacks, EARP public 
consultations from 2002 through early-2003 were not a priority, however. For 
seasoned health and environment groups, EARP consultations fit a familiar 
pattern. NGOs were invited to only two meetings and were expected to study, 
on their own, documents that appeared to have been written for industry 
lawyers by their government counterparts. No funds were provided to assist 
groups that wanted to brief themselves on the implications of EARP for 
public health, or to meet among themselves to develop a public health 
perspective on EARP issues. Industry representatives, by contrast, had more 
than 40 meetings with government as of May 2002 and engaged in discussions 
about EARP on an ongoing basis in their workplaces. A meeting to move the 
scientific agenda forward, planned for September 2003, will be restricted to 
invited scientists.64



The Precautionary Principle
Clean water is so basic to human life that burbling brooks and waterfalls 
are enduring symbols of the life force. Fresh water is also an increasingly 
scarce and coveted resource. In the face of uncertainty about what effect 
PPCPs in the environment will have, the prudent course is to treat PPCPs in 
the water as an urgent issue for short-, medium- and long-term action.

Under CEPA, and in turn under EARP, the federal government affirms Canada’s 
commitment to the precautionary principle.65 Science often lags behind the 
ideal that would permit fully informed decision-making. The precautionary 
principle calls on governments, when faced with partial scientific evidence, 
to tilt policies in favour of protecting health and the environment. Rather 
than requiring the government to demonstrate certainty of harm before 
curtailing a product’s use, the precautionary principle shifts the onus to 
industry to demonstrate a product’s safety before bringing it to market. The 
Canadian government “has an international commitment to implement the 
precautionary principle”; yet a close look at the details in EARP documents 
reveals a compromise that blunts the principle’s edge for protecting health 
and the environment.

Advocates of environmental protection and health protection have advanced 
the precautionary principle as a challenge to the risk management practices 
that now guide government decision-making. Application of the precautionary 
principle would require governments to curtail the use of potentially unsafe 
technologies, even if national economies could suffer some short-term losses 
as a result66. EARP documents state that Canada promotes a precautionary 
approach, “distinctive within science-based risk management”.67 Subsuming 
the precautionary principle within risk management tempers the precautionary 
imperative in the interests of economic goals. An alternatives assessment 
strategy68 would recognize that developing a “clean” technology industry is 
a way to realize direct and indirect economic gains. With vision, Canada 
could lead in the development of ecologically sound PPCP policies and 
technologies, combining our well-established policy expertise in health 
promotion with a forward-looking “green science” agenda.

As the EAR Issue Identification Paper acknowledges, the precautionary 
principle is, “ultimately guided by judgment, based on values (acceptable 
levels of risks).”69 Key questions then become: Whose judgments? Whose 
values? For a manufacturer eager to get a new product to market, zero 
contamination may seem too stringent; a pregnant woman may want no less.

Canadian values traditionally put the public welfare ahead of individual 
gain. Without adequate public consultations, it is impossible to say what 
level of risk the Canadian public is prepared to take with PPCPs. The 
government’s survey suggests a high level of commitment to health and 
environmental protection, among both men and women, but particularly among 
women. Before policy decisions are made, the public needs a plain language 
account of the full range of alternatives and an opportunity to engage in 
discussions. Public consultations should systematically seek the views of 
women and other vulnerable sub-populations.



Conclusions
The government’s Environmental Assessment Regulations Program (EARP) 
proposes narrow regulatory solutions to a broad ecosystem problem. Public 
consultation has been inadequate and priorities have been skewed to address 
the trade concerns of government and industry players. Public health 
concerns, especially prevention via reduced use of PPCPs, are oddly 
secondary or missing entirely from the program. A holistic, health promotion 
program, emphasizing primary prevention, is needed to respond to this 
emerging threat to health and the environment. An effective and just program 
for change will recognize the particular culture-based relationship of women 
to pharmaceuticals and personal care products, as well as women’s biological 
vulnerability to certain chemicals in the environment. One existing model, 
the Green Pharmacy stewardship program, offers a global vision that could be 
adapted readily to Canadian needs.



Recommendations
Make environmental and health protection the central objective of EARP; this 
requires a shift in priorities away from trade objectives;
Emphasize primary prevention strategies (i.e., reduced product use) rather 
than focusing on regulating product approvals;
Broaden and shift the research agenda from its current focus on 
toxicological assessment of products to a holistic, health promotion 
framework, encompassing a range of strategies to be used throughout a 
product’s lifespan (see next point);
Adopt a “product lifespan” approach to regulation, recognizing that 
production, purchase, use, and disposal of products are distinct stages 
requiring different precautionary policies;
Reduce pharmaceutical drug use by promoting the rational use of drugs, 
eliminating over-use, inappropriate use, and the medicalization of healthy 
women’s lives;
Recognize the central role women play in purchasing, using and disposing of 
Pharmaceutical and Personal Care Products;
Ensure that biologically-based differences between women’s and men’s 
sensitivity to pharmaceuticals, and other PPCP chemicals, are fully 
integrated into the scientific research agenda;
Develop a framework for public consultation that will permit genuine 
participation, for example, by providing plain language documentation, 
encouraging members of the public to frame issues in ways meaningful to 
them, and providing funds so that NGOs can meet among themselves, consult 
with their members and analyze the public health and ecosystem dimensions of 
the issues;
Tie the precautionary principle to Canadian values, in which health and 
environmental protection are central, rather than to a risk assessment 
framework emphasizing economic growth.


Sharon Batt is a Halifax-based researcher and health activist. She is on the 
Steering Committee of Women and Health Protection and is a member of the 
independent health coalition Prevention First. She held the Elizabeth May 
Chair in Women’s Health and the Environment at the Atlantic Centre of 
Excellence for Women’s Health at Dalhousie University from 2001-2003. She is 
currently doing PhD studies in the ethics of health research and policy at 
Dalhousie.



Notes
1 This paper was written for Women and Health Protection while I held the 
Elizabeth May Chair in Women’s Health and the Environment at the Atlantic 
Centre of Excellence for Women’s Health, Dalhousie University. I wish to 
thank the following members of Women and Health Protection and its 
affiliates for their helpful comments on an earlier draft of the paper: 
Wendy Armstrong, Warren Bell, MD, Anne Rochon Ford, Brewster Kneen, Joel 
Lexchin, MD, Abby Lippman, PhD, and Ellen Reynolds. All opinions expressed 
in the paper and any errors that remain are my responsibility.

2 For example: Laghi, Brian, Pharmaceuticals found in Canada’s water system. 
Globe and Mail, Sept. 5, 2001, A1; Dennis Beuckert, Drugs in tap water 
health risk. Chronicle Herald (Halifax) Sept. 5, 2001, A1; Mittelstaedt, 
Martin, Drug traces found in cities’ water, Globe and Mail, Feb 10, 2003, 
A1.

3 For example, Bruce Pauli, “Impact of endocrine disrupting compounds on 
amphibian health in agricultural ecosystems”; and Chris Metcalfe, 
“Pharmaceutical Drugs in Canadian Surface Waters: Distribution and Effects 
on Fish”, presented at the Toxic Substances Research Initiative, Ottawa: 
March 5-8, 2002.

4 A more accurate term would be Pharmaceutical, Personal Care and Food 
Products (PPCFPs), to include food additives and genetically modified foods; 
however PPCPs has become the convention in the literature and is used here 
to avoid confusion when citing other texts.

5 Environmental Assessment Regulations, Notice of Intent, Canada Gazette, 
Part 1, Sept. 1, 2002. www.hc-sc.gc.ca/ear-ree/noi_e.html

6 Final Issue Identification Paper: Environmental Assessment Regulations, 
Ottawa: 2003, p 5 www.hc-sc.gc.ca/ear-ree/html.

7 Ibid, p 3

8 Ibid, p3 8

9 Ibid, p 36 .

10 Ibid, p35

11Issue Identification Paper: Environmental Assessment Regulations , Ottawa, 
2003 and Final Issue Identification Paper, Ottawa: 2003.

12 Ibid, p 3-4

13 EAR Newsletter, Vol. 1, No. 1, Spring, 2002, p 2.

14 PPCP FAQs, EPA, p 4

15 Montague, Peter. Drugs in the Water. Rachel’s Environmental and Health 
Weekly, #614, September 03, 1998. 
www.rachel.org/bulletin/bulletin.cfm?Issue_ID=501

16 Daughton, CG. Cradle-to-cradle stewardship of drugs for minimizing their 
environmental disposition while promoting human health. II. Drug disposal, 
waste reduction, and future directions. Environmental Health Perspectives: 
111 (5), May 15, 2003, 777

17 Ibid, 775-785.

18 Final Issue Identification Paper, p 15.

19 19 PPCP FAQs, EPA, p 5

20 See, for example, Kathryn Pauly Morgan, “Contested Bodies, Contested 
Knowledges: Women, Health and the Politics of Medicalization. In S. Sherwin 
(coordinator) The Politics of Women’s Health, Philadelphia, Temple 
University Press, 1998, pp 83-121.

21 J. Houlihan, C. Brody, B. Schwan. Not Too Pretty: Phthalates, Beauty 
Products & the FDA, July 2002 www.nottoopretty.org

22 Daughton, 2002, p 38.

23 F&DA Product Disposal Survey, COMPAS 2002. Appendix on Demographic 
Variations (Gender).

24 Daughton, 2003, Op cit, p 781

25 Many health and environment analysts have noted and theorized about the 
reasons for this gender gap. See, for example, Miriam Wyman in Sweeping the 
Earth: Women Taking Action for a Healthy Climate, Miriam Wyman (Ed.), 
Charlottetown: Gynergy Books, 1999, pp 16-25 and Joni Seager, Earth Folies: 
Coming to Feminist Terms with the Global Environmental Crisis, NY: 
Routledge, 1993, pp 9-12. Consistent with these analyses, a poll undertaken 
by CRIC and the Globe and Mail in June 2003 showed that young women have a 
consistently higher awareness of social issues than do young men. 
www.theglobeandmail.com/servlet/story/RTGAM.20030611.nblow0611/ 
BNStory/SpecialEvents3/ - 51k - 24 Jun 2003/

26 EAR Project Benchmark Survey, Op cit, Appendix.

27 Colburn, T, D Dumanoski and J P Meyers, Our Stolen Future. NY: Dutton, 
1996, p 205; DES Action Canada. Hormonal Pollution Alert , 2001, p 2.

28 See Steingraber, Sandra. Human Breast Milk Contamination Detection of 
Monocyclic Aromatic Amines, Possible Mammary Carcinogens, in Human Milk. 
Cornell University Program on Breast Cancer and Environmental Risk Factors 
in New York State (BCERF). The Ribbon, Vol. 4 No. 3, Early Fall, 1999. 
http://envirocancer.cornell.edu/Newsletter/Genderal/v4i3/rc.milk.cfm ; and 
DeBruin, L.S., Pawliszyn, J.B., and Josephy, P.D., Detection of monocyclic 
aromatic amines, possible mammary carcinogens, in human milk, Chemical 
Research in Toxicology 12: 78-82, 1999.

29 GOA. Drug Safety: Most Drugs Withdrawn in Recent Years Had Greater Health 
Risks for Women. Washington, DC: General Accounting Office, GOA 01-286R; 
Fuller, Colleen. Women and Adverse Drug Reactions: Reporting in the Canadian 
Context. Background paper prepared for Women and Health Protection, March 
2003.

30 The Women’s Health Bureau of Health Canada has developed a training 
program for the inclusion of a gender-based analysis (GBA) in all Health 
Canada work and policies. www.hc-sc.gc.ca/english/women/gba.htm

31 See, for example, Prabha, Khosla and Rebecca Pearl, Untapped Connections. 
Gender, Water and Poverty: Key Issues, Government Commitments and Actions 
for Sustainable Development. NY: Women's Environmental & Development 
Organization (WEDO), 2003. Online at: http://www.wedo.org.


32 See documents posted at: 
http://www.epa.gov/nerlesd1/chemistry/ppcp/greenpharmacy.htm

33 CEPA & the NSNR, see page beginning, “Why is Health Canada Developing new 
regulations?”, available at: www.hc-sc-gc.ca/ear-ree

34 Environmental Assessment Regulations, Notice of Intent, Canada Gazette, 
Part 1, Sept. 1, 2002. www.hc-sc.gc.ca/ear-ree/noi_e.html

35 Frequently Asked Questions – Environmental Assessment Regulations, 
September 2002. Accessed February 2, 2003, at 
www.hc-sc.gc.ca/ear-ree/faq_e.html

36 See, for example, How Safe Are Our Medicines?, Preventing Disease: Are 
Pills the Answer? and Who Benefits?International Harmonization of the 
Regulation of New Pharmaceutical Drugs on the Women and Health Protection 
Web site.

37Final Issue Identification Paper , pp 41-42.

38 Who Benefits? International Harmonisation of the Regulation of New 
Pharmaceutical Drugs. Women and Health Protection in Collaboration with DES 
Action Canada, 2002.

39 Final Issue Identification Paper, p 46.

40 See, for example, Workshop Proceedings for “The Gender of Genetic 
Futures: The Canadian Biotechnology Strategy, Women and Health”, www.cwhn.ca 
and Anne Rochon Ford, Biotechnology and the New Genetics: What it Means for 
Women’s Health, Prepared for the Working Group on Women, Health and the New 
Genetics, February 2001.

41Final Issue Identification Paper, Op cit, p29.

42 Daughton, 2002, p 3

43 Daughton, 2002, p 12

44 Daughton, 2002, pp 17-19

45 “Assessment and Management of Pharmaceutical and Personal Care Products 
in the Canadian Environment: A National Science Agenda.” Environmental 
Assessment Regulations newsletter, Vol. 1, No. 1, Spring 2002, page 3.

46 “Workshop Conclusions” from the powerpoint presentation EAR: Science and 
Research, posted at www.hc-sc.gc.ca/ear-ree

47 Daughton, Op cit, 2002, p 30.

48 Daughton, “Environmental Stewardship of Pharmaceuticals: the Green 
Pharmacy” Powerpoint presentation from the National Groundwater Association 
3 rd International Conference on Pharmaceuticals and Endocrine Disrucpting 
Chemicals in Water, Minneapolis, MN, 19-21, March 2003, slide 5. Available: 
www.epa.gov/nerlesd1/chemistry/ppcp/conference-past.htm.

49 Ibid, p 9

50 Ibid, 41-42.

51 Boivin, M. 1997. The cost of medication waste. Can Pharm J. May 32-39. 
Available: Http://www.napra.org/practice/toolkits/toolkit9/wastecost.pdf. 
Cited in Daughton, 2003, p 781.

52 Ibid, 54.

53 Personal communication, June 26, 2003.

54 Daughton, Op cit, 2002, 39-40.

55 For a complete overview of C.G. Daughton’s Green Pharmacy research ideas, 
see the articles in Environmental Health Perspectives, November 2002 and May 
2003; and the Powerpoint presentation, “Environmental Stewardship of 
Pharmaceuticals: the Green Pharmacy” from the National Groundwater 
Association 3 rd International Conference on Pharmaceuticals and Endocrine 
Disrucpting Chemicals in Water, Minneapolis, MN, 19-21, March 2003. 
www.epa.gov/nerlesd1/chemistry/ppcp/conference-past.htm.

56 Final EAR Issue Identification Paper, p 5.

57 NAPRA, Pharmacy Practice: Recycling and Disposal of Dispensed Drugs, 
Ottawa, Ontario: National Association of Pharmacy Regulatory Authorities, 
Canada, 2002. Available: 
http://www.napra.org/practice/toolkits/pharm-toolkit9.html.

58 Daughton, Op cit, 2002, pp 48-49, 55-56.

59 Ibid, p 15.

60 See Mintzes, Barbara. Direct-to-consumer advertising for prescription 
drugs: when health protection is no longer a priority. Montreal: DES Action 
Canada and Women and Health Protection, 2001.

61 Daughton, Op cit, 2003, p 777.

62 Van Esterik, Penny. Risks, Rights and Regulations: Communicating about 
Environmental Risks and Infant Feeding, 2002. Available at: 
www.yorku.ca/nnewh

63 See, for example, WHEN www.web.net/~when/ ; the Canadian Coalition for 
Green Health Care www.greenhealthcare.ca/index2.htm; and Health Care Without 
Harm www.noharm.org .

64 This assessment is based on the author’s observations at the May 2002 and 
February 2003 meetings, including discussions at the meetings and afterwards 
with NGO, government and industry participants.

65 Final Issue Identification Paper, p 40-41

66 See, for example, O’Brien, Mary. Making Better Environmental Decisions: 
An Alternative to Risk Assessment. Cambridge, MA: MIT Press, 2000.

67 Final Issue Identification Paper, p 38.

68 67 O ’ Brien , M. op cit, pp 3-15.

69 Op cit, p 38.