|
|
Home
| Databases
| WorldLII
| Search
| Feedback
New Zealand Journal of Environmental Law |
Last Updated: 21 January 2023
41
Bisphenol A: A Critique of the
Law’s Failure to Protect the Public from Toxic Exposure
Joshua Pietras*
Scientists are increasingly concerned about the harmful effects of Bisphenol A (BPA), a chemical found in many consumer products including baby bottles and plastic containers. As BPA mimics oestrogen
1. INTRODUCTION
Bisphenol A (BPA) is a ubiquitous chemical used in a variety of consumer products including polycarbonate bottles, plastic containers, flame retardants,
*LLM Candidate, The Australian National University. This article was written in partial fulfilment of a BSc/LLB (Hons) degree at the University of Waikato. It was selected as the winner of the Environmental Defence Society (EDS) University Essay Competition 2013. I would like to thank Professor Alexander Gillespie of Te Piringa Faculty of Law for his helpful guidance and support. Any errors remain my own. Email contact: joshuapietras@gmail.com.
compact discs, thermal receipts and canned food lining.1 There is also a 93 per cent chance that this chemical is inside your body right now.2BPA is an endocrine disruptor; that is, a chemical that interferes with the normal functions of hormones.3 Exposure to endocrine disruptors may affect the expression of genes inside the body. So far, there has been no conclusive evidence on BPA’s health effects, although a mounting body of research suggests that it may be causing reproductive and developmental problems.
Scientific uncertainty over BPA’s effects has made it difficult for governments to take action. In most cases, the law places the burden of proof on regulatory authorities to show that a chemical is unsafe. This paradigm is particularly dicey for BPA as its effects are most likely to be felt during the early stages of development. Unless governments restrict this chemical, the developing foetus and young children are at increased risk of lifelong disease. This article argues that current laws are incapable of protecting our most vulnerable population from hazardous chemicals such as BPA. Thus, it is suggested that a more precautionary approach is needed to control substances that could interfere with the hormonal system. The article is divided into four parts. Part 2 discusses the science behind the developmental origins of disease and how BPA may be causing irreversible harm. Part 3 critically evaluates the law’s response to the BPA controversy, using examples from various jurisdictions. Part 4 investigates the precautionary principle and its role in the regulation of BPA. Finally, part 5 concludes that New Zealand should adopt a
more precautionary approach towards BPA.
2. SCIENCE
2.1 Epigenetics
Every cell inside the human body is encoded with an identical sequence of DNA, which is known as the genome.4 Although our DNA does not change, it is expressed differently across the body’s various cell types. This process
is known as epigenetics.5 Essentially, epigenetics is what makes a lung cell different from a brain cell, or a kidney cell different from a liver cell. This record of cellular differentiation is known as the epigenome.6
2.2 Development
Development is, by definition, epigenetic.7 During the early stages of develop ment, epigenetics plays a vital role in cell production and differentiation. This is an essential process for the normal growth of tissues, organs and systems.8
However, the epigenetic process is also incredibly sensitive to endocrine disruptors in the environment.9 Endocrine disruptors can cause permanent changes in the epigenome, which may then be passed down to offspring. BPA is one type of endocrine disruptor that may affect the epigenetic process.10 To understand how endocrine disruptors work, it is important to first consider some basic features of the endocrine system.11
2.3 The Endocrine System
The endocrine system is made up of a network of glands that secrete hormones into the bloodstream. These hormones are then transported through the bloodstream to their target cells. If the incoming hormone is a match, it will fit inside the cells’ receptors like a lock and key.12 This receptor–hormone interaction signals the cell to start producing new proteins, which can then be used for the normal functioning of tissues and organs.
2.4 Endocrine Disruptors
Endocrine disruptors compete with the body’s natural hormones by latching on to the target cell’s receptors.13 Once an endocrine disruptor has reached the target cell, it will either promote or inhibit very specific parts of the DNA.14 Thus, even in very small concentrations, these chemicals can have a profound impact on the developing organs, tissues and systems.
Synthetic oestrogens are one particularly potent class of endocrine disruptor. These substances mimic the functions of natural oestrogen — the female sex hormone. Oestrogen is important for regulating the onset of puberty, breast tissue growth, menstruation and menopause in women; although it also plays a vital role in male reproduction.15
BPA was first discovered to be a synthetic oestrogen in 1936.16 While it was originally thought to be weakly oestrogenic, recent findings suggest that BPA could be far more potent.17
2.5 Bisphenol A
Hundreds of animal studies have linked BPA to a variety of health problems including declines in sperm count, abnormal penal and urethra development in males, early sexual maturation in females, neurobehavioural problems, type 2 diabetes and immune system disorders.18 In addition, BPA has been shown to cause chromosomal damage in mice offspring, suggesting that its effects could be intergenerational.19
Due to ethical and legal constraints, it is not possible to directly test the effects of BPA on humans.20 Nevertheless, epidemiological studies have linked high concentrations of BPA with cardiovascular disease and diabetes.21 In addition, occupational exposure to BPA has been shown to decrease sperm quality and sexual function in men.22
at 230.
2.6 Bisphenol A and Early Childhood Development
There are a number of reasons why children are particularly vulnerable to BPA’s effects.
Firstly, the timing of exposure is a crucial factor. During the early stages of development, the body uses hormones to regulate the growth of organs, tissues and systems. If an endocrine disruptor is present during this period, it can interrupt the body’s normal hormone levels.23 The history of diethylstilbestrol (DES) highlights this danger all too well. DES is a potent oestrogen that was prescribed as an antimiscarriage drug in the 1940s to 1960s. Years later, it was discovered that exposure to DES inside the womb had caused many of the so called “DES daughters” to develop a rare form of vaginal cancer.24 Although BPA might not be quite as potent as DES, children are more likely to be exposed to BPA on a daily basis.
Secondly, children have lesser defences than adults. Both the immune system and liver have not fully matured and cannot metabolise BPA efficiently.25 Thirdly, children are more likely to have a higher dietary exposure to BPA
as they tend to eat more food per body weight than adults.26
Finally, a large number of children’s products contain BPA. For example, polycarbonate baby bottles are known to leach high concentrations of BPA when sterilised under hot water.27 BPA is also used in plastic lunch boxes, infant formula cans and toys — products used almost exclusively by young children.
2.7 Science — Summary
In sum, BPA is likely to affect the epigenetic process and could be causing serious harm. For this reason, BPA has caught the attention of regulators over the last few years. The following part will discuss how the law regulates toxic chemicals in relation to the BPA controversy.
3. LAW
3.1 International Environmental Law
International environmental law has responded to the growing risk of contamination from pesticides and other industrial chemicals. Although a number of conventions regulate the trade in toxic chemicals, two of the most important agreements will be considered here: namely, the Stockholm Convention on Persistent Organic Pollutants and the Rotterdam Convention on Prior Informed Consent Procedure for Certain Hazardous Chemicals.
The Stockholm Convention aims to eliminate the use and production of certain persistent organic pollutants (POPs). These substances raise a number of health concerns including cancer, immune system disorders and reproductive problems.28
The Stockholm Convention obliges parties to reduce, and in some cases completely eliminate, a group of POPs, collectively known as the “dirty dozen”.29 Parties are required to develop their own Implementation Plan to demonstrate how they will fulfil their obligations.30 The Convention also establishes a rigid compliance and enforcement regime.
New chemicals can be added under the Stockholm Convention as long as they qualify as POPs. By definition, these chemicals share the following properties:31
(1) they are highly toxic and persistent;
(2) they are capable of being transported across international boundaries; and
(3) they bioaccumulate in fatty tissue.
Based on the above criteria, BPA does not meet the definition of a POP. Although there is now evidence to suggest that BPA could be highly toxic, it
does not persist in the environment nor does it bioaccumulate.32 For this reason, the Stockholm Convention is not the appropriate mechanism for controlling this chemical.
The Rotterdam Convention is based on the idea of prior informed consent (PIC). This process prevents the exportation of hazardous chemicals unless the importing party gives its consent before accepting them.33
The Rotterdam Convention requires parties to disclose their position for all chemicals covered by the PIC list.34 These decisions are compiled into a report and distributed so that all the parties are kept up to date with any restrictions. Importantly, parties must not export any of the PIC chemicals if this would contravene the decision of another party.35
The scope of the Rotterdam Convention is quite narrow as it is mainly concerned with pesticides and industrial chemicals. For this reason, BPA has not yet been added to the PIC list. Even if BPA was covered by the Rotterdam Convention, the PIC procedure would become quite difficult as BPA is one of the most ubiquitous chemicals on the international market. Therefore, it is unlikely that BPA will be added to the PIC list any time soon.
3.2 Regional Regulation of Chemicals: The European Union
The EC’s Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) came into force in 2007. REACH provides a regulatory overhaul for all chemicals manufactured and imported into Europe. Prior to REACH, chemicals were regulated under a patchwork of different laws and policies.36 The old system “grandfathered in” all chemicals that were already on the European market — even though there was little or no data on their risks.37 In contrast, companies had to carry out extensive testing and
provide data for new chemicals.
This data gap is now beginning to close as REACH now requires pre market testing for all chemicals. The philosophy behind REACH is that no chemical should be placed on the market, unless the industry can provide sufficient documentation.38 In other words, REACH adopts a “no data, no market” approach.
(i) Registration
Before a company can gain access to the market, it must register its chemicals with the European Chemicals Agency (ECHA). The registration process will depend on the chemical’s annual production volume — in general, the higher the tonnage, the more stringent the requirements.39 For highproduction chemicals (>10 tonnes per annum), a chemical safety report (CSR) will be required. The purpose of the CSR is to provide information on a substance’s hazards. If the substance is identified as hazardous, the CSR must include information on exposure scenarios and a risk management plan.40 A CSR is also required for substances that are reasonably expected to be released from products during their normal use.41
The registration process has some important implications for BPA. As BPA is a very highproduction chemical, companies wishing to manufacture or import this chemical into Europe will have to submit a CSR.42 In addition, companies planning to sell large amounts of polycarbonate plastics will also have to submit a CSR as BPA is “reasonably expected” to be released from these products.
(ii) Evaluation
ECHA is also responsible for evaluating the CSRs. If a chemical is found to pose a significant risk to human health and safety, ECHA can order companies to submit more data or conduct further testing.43 If ECHA discovers that a
substance is particularly hazardous, it may decide to take further action under REACH’s authorisation and restrictions procedures.44
(iii) Authorisation
The authorisation process imposes tough restrictions on socalled “substances of very high concern” (SVHC). This includes any substance that is: carcinogenic, mutagenic and reprotoxic (CMRs); persistent, bioaccumulative and toxic (PBT); very persistent, bioaccumulative and toxic (vBvP); as well as certain types of endocrine disruptors.45 Companies cannot produce these chemicals unless they obtain authorisation from the European Commission (EC).
The EC may grant authorisation under two separate grounds: (1) where exposure to a substance can be adequately controlled; or (2) where the socio economic benefits outweigh the risks, taking into account any alternative substances.
To date, BPA has not been classified as a SVHC.46 In the event that BPA is so classified, it is unlikely that the EC would grant authorisation under the first ground, as it would be difficult to control exposure to BPA. However, companies could still argue that the socio-economic benefits outweigh the potential risks. For example, epoxy resin made with BPA prevents contamination in tinned food — a clear benefit; whereas the risks associated with BPA exposure are still equivocal.
(iv) Restrictions
Finally, the EC may impose communitywide bans and restrictions whenever a substance or article presents an “unacceptable risk”.47 So far, thousands of substances have been restricted under the process.
It is interesting to note that DEHP is listed as a restricted substance. Like BPA, DEHP is a known endocrine disruptor and is also a common ingredient in plastics.48 Unlike BPA, however, DEHP is strictly controlled by the REACH programme.
While REACH now applies to virtually all chemicals in Europe, a few types of chemicals are regulated under separate regimes. For example, chemicals used in food packaging and containers are regulated under the EU’s Regulation on Food Contact Materials. The European Food Safety Authority (EFSA) is responsible for upholding this regulation and setting the appropriate safety standards. As such, the EFSA plays a vital role in the regulation of BPA.
The EFSA approved BPA as a food contact material in 2002,49 and set its first safety standard in 2006.50 However, following new evidence over BPA’s effects, a few members of the EU decided to adopt their own national measures. Thus, in 2010 France banned BPA from all baby bottles, with Denmark taking a step further and banning BPA from all food products intended for children.51 With these restrictions in place, the EC asked the EFSA to reconsider the 2006 safety level.52 After months of consultation, the EFSA decided that the recent evidence on BPA’s effects did not warrant a new safety standard.
Dissatisfied with the EFSA’s response, the EC decided to impose a communitywide ban on the use of BPA in baby bottles.53 The decision was a victory for public health agents and worried parents across Europe. However, their enthusiasm was not shared by the plastics industry. Shortly after the announcement, the European Plastics Association issued a public statement claiming that European BPA producers were “deeply disturbed by the EC’s proposal to ban polycarbonate baby bottles” and that it had ignored the “weight of scientific assessments”.54
Although the EC has banned BPA from polycarbonate bottles, there are currently no plans for further restrictions.
3.3 United States of America
Over the last few decades, the law has failed to protect the American public from toxic exposure. Two of the main culprits will be considered here: namely,
52 At 400.
the Toxic Substances Control Act (1976) and the Federal Food, Drug, and Cosmetic Act (1938). Both of these Acts are at the centre of the BPA debate in the USA.
(i) History
In 1976 Congress passed the Toxic Substances Control Act (TSCA) to fill in the gaps of previous legislation that had traditionally focused on one pollutant at a time.55 To achieve this end, Congress authorised the Environmental Protection Agency (EPA) to enforce the Act and develop its own regulations.56
(ii) “New” and “existing” chemicals
The TSCA aims to provide a single regulatory process for all chemicals. In practice, however, the Act contains separate rules for “existing” and “new” chemicals. Chemicals listed under the TSCA inventory are referred to as “existing” chemicals and do not require any data or testing. Conversely, all chemicals not covered by the TSCA inventory are referred to as “new” chemicals. Before “new” chemicals can be listed, companies must submit a pre manufacture notice outlining all the information they have on the chemical.57
When the TSCA first came into force in 1976 it “grandfathered in” the vast majority of chemicals on the US market — despite little being known about their risks.58 As a result, BPA and some 62,000 other chemicals were added to the inventory overnight.59
In theory, the EPA may still restrict existing chemicals where they are found to present an “unreasonable risk”. In this case, companies will have to provide further information on their chemicals. But unless the EPA had some data from the outset, it will be very difficult to provide any evidence of the chemicals’ risks.60 It is precisely this regulatory “catch22” situation that has left the EPA powerless in the battle against BPA.
(iii) BPA and the TSCA
Following the devastating effects of DES in the 1970s, the US National Toxicology Program (NTP) began to test a number of endocrine disruptors. However, traditional toxicology methods were based on the idea that “the
dose makes the poison”. Thus, it was assumed that BPA’s reproductive effects would diminish with dose. By measuring toxicity in this way, the NTP failed to account for one other crucial variable — the timing of exposure.The EPA set the first safety standard for BPA in 1988 at 0.05 mg per kg of body weight per day.61 To this day, the EPA has never updated the safety standard, despite new evidence that BPA could be harmful at much lower concentrations.
Furthermore, the EPA has not taken any action under the TSCA as it still cannot decide whether BPA presents an “unreasonable risk”.62 Instead of proceeding with precaution, the EPA prefers to wait for unequivocal evidence that lowdose exposure to BPA “causes” adverse health effects — a conclusion that is unlikely to be reached any time soon.
While the TSCA applies to most chemicals, it contains exceptions for substances already regulated under other statutes.63 For this reason, the BPA debate will also be assessed under the USA’s food safety legislation.
(i) Overview
Congress passed the Federal Food, Drug, and Cosmetic Act (FDCA) in 1938. The FDCA authorises the Food and Drug Administration (FDA) to regulate food safety standards in the USA.
(ii) Food additives
In the decades following the passage of the FDCA, the food additives industry began to explode.64 Congress soon recognised the need for tougher restrictions on these chemicals and passed the Food Additives Amendment in 1958.
The Amendment requires all companies to prove that their food additives will be safe. Section 201(s) of the FDCA defines “food additives” quite broadly and includes any substance that is “reasonably expected” to directly or indirectly become part of the food.65 Although BPA is not directly used as a food additive, it is “reasonably expected” to migrate from plastic packaging and is therefore an “indirect food additive”. However, the statutory definition of
65 At 243.
“food additives” excludes any substance that is “generally regarded as safe”.66 Thus, in 1963 the FDA approved BPA for use in food containers as it was not known to cause any ill effects.67 This approval meant that companies could use BPA in all types of food packaging.
(iii) The Delaney Clause
The 1958 Amendment also contains an absolute prohibition on the use of carcinogens in food.68 This rule became known as the Delaney Clause, named after Congressman James Delaney who originally proposed the Amendment. In essence, the Delaney Clause states that the FDA must not approve any food additive that is known to cause cancer.69
Upon coming into force, the 1958 Amendment sent the chemicals industry into a frenzy. Companies were worried that if the Delaney Clause was given a strict interpretation, a number of pesticides and other chemicals would become banned overnight. Instead, the Delaney Clause was given a liberal interpretation so that it would only apply to “quantifiable” amounts of carcinogens. Thus, if the carcinogen could not be detected, there was no need to regulate it.
Today, this de minimis exception fails to account for BPA’s lowdose effects. BPA defies the rules of toxicology; that is, its low-dose effects are often more potent than its highdose effects.70 Thus, BPA might still be hormonally active even at nondetectable concentrations.71
Another problem is that the Delaney Clause only prohibits carcinogenic food additives. As there is no substantial evidence to show that BPA acts as a direct carcinogen, it cannot be prohibited under this clause.
For some thirtyodd years, BPA managed to stay out of the regulatory spotlight. However, all of that changed in the early 1990s when Theo Colborn, Dianne Dumanoski and John Peterson Myers released their timeless narrative Our Stolen Future, outlining the effects of endocrine disruptors on early childhood development.72 The book’s success helped move the topic of endocrine disruption away from the scientific community and into the public forum.
66 J O’Reilly Food and Drug Administration (3rd ed, Thomson/West, St Paul, 2007) at ch 113. 67 Cranor, above note 8, at 40–41.
In 1997 a crucial discovery was made by Frederick vom Saal — one of BPA’s most outspoken critics. Vom Saal discovered that lowlevel exposure to BPA harmed the prostate of male rats.73 This finding provided an impetus for further research, and over the next 10 years, hundreds of studies began to link BPA with a variety of illnesses.By the mid2000s, consumer protection groups started to target children’s products as unnecessary sources of BPA.74 These product campaigns helped decrease the public’s confidence in BPA and created a demand for safer alternatives.
However, the real tipping point came in September 2008 when the NTP released its report on BPA, expressing “some concern” over its effect on prostate development and the behavioural effects in foetuses, infants and young children.75 This was the first time that a US government agency had formally questioned the safety of BPA. Just two weeks later, the results of a ground breaking epidemiological study were released. The Lang Study linked high urinary concentrations of BPA with cardiovascular disease, type 2 diabetes and liver deficiencies.76 In many ways, the NTP’s report and the Lang Study confirmed what many had always suspected — that BPA was not harmless at all.
By 2009, demand for BPAfree products was so high that all major baby bottle producers agreed to remove the chemical from their products.77 Major retailers like WalMart followed suit and announced that they would no longer stock BPA baby bottles; while Sunoco — one of the largest producers of BPA
— revealed that it would not sell the chemical to manufacturers of children’s products. Although the polycarbonate baby bottle was now commercially dead, the voluntary ban did not stop manufacturers from using BPA in other consumer products.
By 2011, the whole country was affected by the voluntary ban and 11 states had taken legislative action against the use of BPA in baby bottles. To prevent any further restrictions, the plastics industry petitioned the FDA to formally ban BPA from baby bottles.
On 2 July 2012 the FDA announced that BPA could no longer be used in baby bottles. Shelley Burgess, a spokeswoman for the FDA, stated that the decision was not based on any concern for public health and that the FDA “continues to support the safety of BPA for use in products that hold food”.78 The FDA’s decision was heavily criticised, with one NGO calling the ban “purely cosmetic”.79Currently, there are no further plans to limit the public’s exposure to BPA. While the FDA concedes that more research is needed, it continues to uphold the safety of BPA.80
3.4 Domestic Regulation of Chemicals: China
In 2009 the Chinese Government passed the New Chemical Substance Regulation (New Chemicals Regulation), colloquially known as China REACH.81
The New Chemicals Regulation requires companies to file an application with China’s Chemical Registration Centre. Each application must include general information on the chemical, test reports and a risk assessment. The application is then sent to the Expert Assessment Committee, which assigns the appropriate risk category and controls.82 If the chemical is approved, a Registration Certificate is issued outlining basic information on the chemical’s production volume, risk management category and control measures.
Unlike the EC’s REACH programme, the New Chemicals Regulation only applies to “new chemicals”: namely, substances that are not listed under the Inventory of Existing Chemical Substances in China (IECSC).83 When the New Chemicals Regulation came into force in 2009 it “grandfathered in” all chemicals that had entered China before 15 October 2003. As BPA had been used in China for a number of decades, it did not require any data or testing and was automatically added to the IECSC list.
In 2011 the Chinese government passed the Regulations on Safe Manage ment of Hazardous Chemicals. The Hazardous Chemicals Regulation imposes tough restrictions on all substances listed under the Catalogue of Hazardous Chemicals. Although the Catalogue had not been updated since 2002,84 a new version was released on 10 April 2014.85 The new catalogue has some important implications for BPA as China’s Ministry of Health recently announced that BPA would be added to the “Hazardous Chemicals of Priority Environmental Concern” (HCPEC) list.86 Once the new catalogue comes into force, BPA will be regulated under a strict licensing and controls regime.
It is important to note that the Hazardous Chemicals Regulation contains an exclusion clause for chemicals already covered by other legislation.87 For this reason, China’s food safety laws will continue to regulate BPA as a food contact additive.
In 2009 China’s Ministry of Health revised the Hygienic Standard Uses of Additives in Food Containers and Packaging Materials.88 The Standard provides a list of authorised food contact additives and the circumstances in which they may be used. For example, if a food contact additive exceeds its specific migration level (SML), it can no longer be used in food production.89 Currently, BPA is authorised for use in food contact coatings and adhesives, subject to a SML of 0.6 mg/kg.90 As there has been little research on dietary exposure to BPA in China,91 it is unclear whether the current SML is sufficient.
The Standard also contains a list of substances that cannot be used in food packaging. In 2011 BPA was added to the list so that it may no longer be used
(last accessed 10 May 2013).
91 YQ Huang and others “Bisphenol A (BPA) in China: A Review of Sources, Environmental Levels, and Potential Human Health Impacts” (2012) 42 Environment International 91.
in baby bottles.92 Whether China will ban BPA from other products in the near future remains to be seen.
3.5 New Zealand
The main tool for regulating toxic chemicals in New Zealand is the Hazardous Substances and New Organisms Act 1996 (HSNO Act). Before the HSNO Act came into force, toxic chemicals were regulated under different statutory regimes such as the Pesticides Act 1979 and the Toxic Substances Act 1979.93 Nowadays, the HSNO Act provides a single process for controlling all hazardous substances.94
The purpose of the HSNO Act is to “protect the environment, health and safety of the community from the adverse effects of hazardous substances”.95 Section 2(1) defines a “hazardous substance” as any substance possessing one or more of the following properties: explosiveness, flammability, capacity to oxidise, corrosiveness, toxicity, and ecotoxicity.
A substance will only be deemed “hazardous” if it exceeds the threshold levels prescribed by the HSNO regulations.96 If the substance exceeds the relevant threshold level, it will be categorised according to its hazardous properties.97 For example, BPA is currently categorised under Class 6 and Class 9, due to its toxic and ecotoxic properties.98
The HSNO regulations provide a series of controls to minimise the risks associated with each type of hazardous substance.99 For substances categorised under Class 6 (toxic), an acceptable daily exposure (ADE) level must be set; that is, the amount of a hazardous substance that would be unlikely to cause adverse health effects, given a lifetime of daily exposure.100 Currently, there are no safety standards for BPA, even though the regulations state that an ADE
Gazette 1655 at 1733.
must be set in accordance with international standards.101 At the very least, New Zealand’s Environmental Protection Authority could have adopted the same safety levels used in Europe or the USA. To date, the Environmental Protection Authority has only banned BPA from cosmetic products.102Although the HSNO Act covers most hazardous substances, it will not apply if an otherwise “hazardous substance” has been incorporated into food or used as a food additive. For this reason, BPA is also subject to New Zealand’s food safety laws.
The Australian New Zealand Food Standards Code (the Code) authorises the Ministry for Primary Industries (MPI) to regulate food safety standards in New Zealand.103 Two features of the Code are relevant to the BPA debate: namely, Part 1.2 (labelling requirements) and Part 1.4 (contaminant and residue standards).
(i) Labelling
Standard 1.2.3 of the Code provides for mandatory warnings and advisory statements in relation to certain foods and foods containing particular substances. These labelling requirements are normally used to warn consumers about any harmful substances that could be present in the food.104 For example, foods containing phytosterols must include an advisory statement that the product might not be suitable for young children or pregnant women.105 Currently, the Standard does not require any warnings or advisory statements for products containing BPA.
(ii) Contamination
Standard 1.4.1 outlines the maximum levels of toxins that may be present in food as a result of contact with the packaging. For example, the maximum amount of tin that may be present in canned foods is set at 250 mg/kg.106 Again, the Standard makes no explicit mention of BPA. When questioned on this, the MPI stated that it:107
is very aware and sensitive to the public concerns about the potential adverse health effects of exposure to bisphenol A, but remains in the opinion that there is no health risk for consumers, including infants ...
To date, New Zealanders’ dietary exposure to BPA is estimated to be much lower than the maximum levels set by the EFSA and FDA.108 Despite the fact that there is now good reason to believe that BPA could still be harmful at very low doses, the MPI has chosen to ignore the weight of the evidence.109 Instead, it prefers to follow the same myopic approach taken by the EFSA and the FDA.110
3.5.3 New Zealand Market Response
Recently, all of New Zealand’s major baby bottle suppliers have started to phase out polycarbonate bottles.111 Other companies like Wattie’s have gone a step further and completely removed the chemical from all babyfood products.112 Despite these individual efforts, products containing BPA are still pervasive across stores in New Zealand.113 For example, Foodstuffs (owner of Pak’nSave and New World supermarkets) has stated that it has no plans to withdraw products containing BPA; whereas Progressive Enterprises (owner of Countdown and Woolworths) has revealed that it would not be taking any action, although it does support its suppliers’ voluntary phaseout.114 Furthermore, the New Zealand Food and Grocery Council maintains that the voluntary phaseout is a mere response to consumer demand and does not concern any issues of product safety.115
3.6 Conclusion on Law
There is now strong evidence to suggest that BPA may be causing serious damage, particularly in young children. But because BPA defies the rules of classical toxicology, scientists have been unable to establish a clear link between exposure and subsequent harm.116 This is problematic as the law tends to treat chemicals as safe, until proven otherwise.117 Unless some precautionary measures are put into place, the population will continue to be exposed to BPA.
4. SOLUTION — PRECAUTIONARY MEASURES
4.1 What is Precaution?
Precaution is the linchpin of environmental law and policy. Essentially, precaution is what guides regulators to act whenever the harmful effects of a proposed activity are uncertain.118
Precaution can be implemented on a scale ranging from weak (the precautionary approach) to strong (the precautionary principle). For example, where a chemical is suspected of causing harm, a precautionary approach might require further studies into its effects; whereas the precautionary principle might call for a total ban.119
Where there is a risk of irreversible and serious harm, the precautionary principle will normally be the preferred option. The Wingspread Conference of 1998 provides a useful definition:120
When an activity raises threats of harm to human health or the environment, precautionary measures should be taken even if some cause and effect relationships are not fully established scientifically. In this context the proponent of an activity, rather than the public, should bear the burden of proof.
This articulation of the precautionary principle is useful for assessing the risks posed by BPA. As it is difficult to establish a causal relationship between exposure to BPA and subsequent harm, the precautionary principle would allow for a moratorium until more is known about this substance.The following section will discuss how the international community, regional bodies and national jurisdictions have viewed the precautionary principle in relation to the BPA controversy.
4.2 International Environmental Law
The preamble of the Stockholm Convention states that the parties are “mindful of Principle 15 of the Rio Declaration” — the most famous statement of the precautionary principle.121 In practice, however, the scope of the Stockholm Convention is quite narrow and only restricts a few types of POPs. Moreover, parties wishing to add new POPs are required to provide extensive scientific data.122 For these reasons, the Stockholm Convention applies a very general and weak version of the precautionary principle.
The Rotterdam Convention does not expressly refer to the precautionary principle — although the PIC procedure does contain some precautionary elements.123 When it comes to adding new chemicals, however, the Convention wears thin on precaution. Before a chemical can be added to the PIC list, at least two countries from two different regions must file a notification. Upon receiving the notification, the Chemicals Review Committee must carry out an extensive scientific risk evaluation.124 Finally, any recommendation to add a new chemical must be approved by a majority vote at the Conference of the Parties.125 This prolonged and arduous process makes it difficult for parties to exercise precaution when adding new chemicals to the PIC list.
122 At 619.
(Kluwer Law International, The Hague, London, Boston, 2002) at 80.
4.3 Europe
The European Union is one of the most outspoken champions of the precautionary principle.126 In particular, art 191 of the EC Treaty expressly states that European environmental policy should be based on the precautionary principle.127
The REACH regime is directly related to the precautionary principle.128 REACH places the burden on companies to test their chemicals and submit the relevant data. This registration process, however, does not require companies to prove that their chemicals will be safe. Rather, companies must provide the relevant information so that ECHA can conduct its own risk assessment.129 If the chemical’s effects are uncertain, ECHA will normally carry out its own testing and decide if any restrictions are needed. Thus, ECHA will ultimately have to show that BPA is a SVHC before it can take any action. For this reason, REACH does not apply a strong version of the precautionary principle.
Article 7 of the Basic Regulation on Food Law states that the EFSA must have regard to the precautionary principle whenever there is scientific uncertainty. However, the precautionary principle is just one of a number of factors to be considered.130 In making its decision, the EFSA must also weigh up the economic, social and political consequences.131 Thus, it is unlikely that the EFSA will ban BPA any time soon, as even slight restrictions could have a huge impact on the EU’s trade market.132
chemicals sector (Milieu, TMC Asser, Pace, Brussels, 2011) at 12.
It is safe to assume that the EC’s ban on polycarbonate bottles was motivated by the precautionary principle. In any event, the bottle ban highlights a missed opportunity for the EC to impose tighter restrictions on the use of BPA.
4.4 United States of America
Traditionally, the USA has viewed the precautionary principle as an unjustified restraint on economic growth.133 Instead, government agencies must generally show that there is an “unreasonable risk” before they can take action against a product or proposed activity.134
The TSCA is no exception to this way of thinking. In theory, s 6 allows the EPA to restrict any substance that presents an “unreasonable risk”. This seemingly precautionary language, however, fails to reflect the strong evidential burden that the EPA must satisfy.135 Because manufacturers are not required to test their chemicals, the EPA will often have to conduct its own testing or simply wait until some harm has occurred.136 By the time the EPA has discovered an “unreasonable risk”, it will generally be too late to protect the public from toxic exposure. This problem is particularly acute for BPA as it can take a number of years for its effects to become manifest.
Even if the EPA finds that a substance presents an “unreasonable risk”, its decision can still be challenged in court. In Corrosion Proof Fittings v EPA, the Fifth Circuit Court of Appeal overturned the EPA’s ruling on asbestos.137 The Court held that the EPA did not have sufficient proof that each and every use of asbestos would cause actual harm. If the EPA could not successfully ban asbestos — an undisputed carcinogen — the chances of a similar ban against BPA being upheld are incredibly slim.
The FDCA provides an early example of the precautionary principle.138 The Act prevents the use of all food additives, unless the manufacturer can show that the proposed food additive will be safe.139 In most cases, “safety” will be based on what the pertinent scientific community “generally regards as safe”.140 Prima facie, the FDA could restrict BPA in the interests of public safety, given that the vast majority of studies have expressed concern over this chemical.141 Instead, the FDA has ignored most of these studies for failing to comply with its regulation on Good Laboratory Practice (GLP). While GLP assures consistency in safety data, it also encourages the use of outdated techniques that simply cannot account for BPA’s lowdose effects.142 To date, the FDA has given more weight to a handful of GLP industryfunded studies than to hundreds of independent studies. Ironically, none of the industryfunded studies were able to replicate BPA’s lowdose effects.143 By demanding strict compliance with GLP, the FDA has disregarded some of the most compelling evidence against BPA.
The FDA’s decision to ban BPA from all baby bottles was in no way motivated by precaution. Instead, the ban merely reflected what companies were already doing in response to public pressure.144 If the FDA was truly concerned about protecting young children from BPA, it would have banned the chemical from all food products intended for children.
4.5 China
In recent years, the Chinese Government has started to confront the environ mental costs of rapid economic growth.145 While China’s environmental law
regime is still in its infancy, a few key concepts are now beginning to emerge: namely, the “prevention first” principle.146 This concept holds that pollution should be prevented at its source in preference to being controlled after it is released.147 While “prevention first” may be a useful policy for controlling China’s pollution problems, it cannot be used to prevent toxic exposure more generally. For this reason, the precautionary principle is a useful tool for filling in the gaps in China’s environmental law regime.148
In the last few years, China’s chemical regulations have moved in the direction of REACH.149 Much like its European counterpart, China’s New Chemicals Regulation requires companies to provide test data and assessments. However, the New Chemicals Regulation does not require companies to prove that their chemicals will be safe. Instead, companies only have to submit data so that the Expert Assessment Committee can carry out its own investigations and assign the appropriate controls. Accordingly, the New Chemicals Regulation only applies a weak form of precaution.
In contrast, China’s Regulation on Hazardous Chemicals applies a strong version of precaution.150 The Regulation prohibits all substances listed under the Hazardous Chemicals Catalogue, unless a company obtains a production licence. In any event, a licence will only be granted after the company has carried out a plethora of tests and provided numerous safety reports.151 The Ministry of Health’s recent decision to include BPA on the HCPEC list is also a promising step. While scientists continue to debate BPA’s risks, China has chosen to treat BPA as a highly toxic substance.
China’s decision to ban BPA from baby bottles could set the scene for further restrictions. Once the HCPEC list comes into force, tough restrictions on the production of BPA might encourage manufacturers to look for safer alternatives.
4.6 New Zealand
Since 1992, New Zealand has applied the precautionary principle to a number of its environmental policies.152 In most cases, the importance of precaution is implicit; as with the Resource Management Act 1991.153 In other cases, precaution is dealt with more explicitly.
Precaution is an inherent part of the HSNO Act. Section 7 of that Act explicitly refers to the “precautionary approach”:154
All persons exercising functions, powers and duties under this Act ... shall take into account the need for caution in managing adverse effects where there is scientific and technical uncertainty about those effects.
When the HSNO Act first came into force in 2001, s 7 was given quite a narrow interpretation.155 Nowadays, the courts appear to be taking a more liberal approach. An example of this was seen in the 2007 case of National Beekeepers v Chief Executive of the Ministry of Agriculture.156 After reviewing the legislative history of s 7, the Court of Appeal noted that:157
[in adopting] the precautionary principle ... Parliament was concerned to ensure a high standard of environmental protection was the overriding goal of the new legislation
157 At [25].
Section 7 clearly shows that Parliament intended to place a high value on precaution.158 To achieve this end, the section requires the Environmental Protection Authority to adopt a precautionary approach in protecting the public from hazardous substances. While BPA has been categorised as a toxic and ecotoxic substance, the Environmental Protection Authority has failed to lay down any safety standards. It makes little sense to categorise a substance as hazardous if there are no corresponding controls to minimise the risks of harmful exposure. For this reason, the Environmental Protection Authority has not taken a precautionary approach in protecting the public from BPA.
The MPI has also failed to adopt a precautionary approach. According to its mandate, the MPI aims to base its risk management decisions on “sound science” and apply “a precautionary approach when faced with scientific uncertainty”.159 In doing so, the MPI may require mandatory labelling or establish acceptable daily intakes for chemical residues in food.160
Despite widespread uncertainty over BPA’s effects, the MPI has chosen not to take any action. Its current position is that there is simply not enough scientific evidence to conclude that low-level exposure to BPA poses any kind of health concerns.161 Instead of adopting a precautionary approach, the MPI prefers to wait for some concrete proof on BPA’s lowdose effects.
5. CONCLUSION: WHERE TO FROM HERE?
Although some questions remain, there is now arguably enough evidence to conclude that BPA may cause serious health problems. In the absence of certainty, precautionary measures are needed to protect the public from this chemical.
So far, however, the precautionary principle has failed to carry the day. In weighing up BPA’s risks, regulators continue to overlook a number of crucial factors such as the timing of exposure, lowdose effects, and the delayed onset of harm. By the same token, the law tends to place the burden of proof on
regulators to show that a chemical is unsafe.162 Unless regulators can satisfy this high scientific and evidential burden, companies will continue to expose the population to BPA.In any event, the BPA controversy highlights an even greater issue. New Zealand needs to make better use of the precautionary principle, not just for BPA, but in the way we regulate all chemicals. Currently, our HSNO Act permits the use of hazardous substances, provided that they can be adequately controlled. Yet BPA is not adequately controlled. New Zealand must adopt a prohibitive policy and require companies to prove that their chemicals will be safe. Alternatively, New Zealand could phase out all hormonally active chemicals from consumer products.163
The time is also right for the MPI to ban BPA from all food and beverage products. Although the recent controversy has caused some suppliers to phase out polycarbonate bottles, BPA is still found in food containers, tinned foods and infant formula cans. For this reason, a blanket ban is necessary to eliminate all routes of dietary exposure.
In sum, it is unlikely that science will deliver any neat and clearcut answers on BPA any time soon.164 So should we wait and risk harming our own health, and more importantly, our children’s health? Or should we take some basic precautionary measures? By now the answer should be clear. Assuming that BPA is not harmful would be a poor bet to make. For this reason, New Zealand should invoke the precautionary principle and take immediate action against BPA.
NZLII:
Copyright Policy
|
Disclaimers
|
Privacy Policy
|
Feedback
URL: http://www.nzlii.org/nz/journals/NZJlEnvLaw/2014/3.html