Genomic Beacons

Yet another genomic privacy article, this time 'Privacy Risks from Genomic Data-Sharing Beacons' [PDF] by Suyash S. Shringarpure and Carlos D. Bustamante in (2015) 97(Nov) The American Journal of Human Genetics 1–16.

The authors indicate

The human genetics community needs robust protocols that enable secure sharing of genomic data from participants in genetic research. Beacons are web servers that answer allele-presence queries—such as ‘‘Do you have a genome that has a specific nucleotide (e.g., A) at a specific genomic position (e.g., position 11,272 on chromosome 1)?’’—with either ‘‘yes’’ or ‘‘no.’’ Here, we show that individuals in a beacon are susceptible to re-identification even if the only data shared include presence or absence information about alleles in a beacon.Specifically, we propose a likelihood-ratio test of whether a given individual is present in a given genetic beacon. Our test is not dependent on allele frequencies and is the most powerful test for a specified false-positive rate. Through simulations, we showed that in a beacon with 1,000 individuals, re-identification is possible with just 5,000 queries. Relatives can also be identified in the beacon. Re-identification is possible even in the presence of sequencing errors and variant-calling differences. In a beacon constructed with 65 European individuals from the 1000 Genomes Project, we demonstrated that it is possible to detect membership in the beacon with just 250 SNPs. With just 1,000 SNP queries, we were able to detect the presence of an individual genome from the Personal Genome Project in an existing beacon. Our results show that beacons can disclose membership and implied phenotypic information about participants and do not protect privacy a priori. We discuss risk mitigation through policies and standards such as not allowing anonymous pings of genetic beacons and requiring minimum beacon sizes.

They go on to comment

In the coming decade, a great deal of human genomic data, along with linked phenotypes in electronic health records, will be collected in the context of health care. A major goal of the human genomics community is to enable efficient sharing, aggregation, and analysis of these data in order to understand the genetic contributors of health and dis- ease. Previous large-scale data-sharing approaches have had limited success because of the potential for privacy breaches and risks of participant re-identification. Homer et al. and others showed that subjects in a genome- wide association study could be re-identified with the use of allele frequencies, resulting in the removal of publicly available allele-frequency data.

The Beacon Project by the Global Alliance for Genomics and Health (GA4GH) aims to simplify data sharing through a web service (‘‘beacon’’) that provides only allele-presence information. Users can query institutional beacons for information about genomic data available at the institution. Queries are of the form ‘‘Do you have a genome that has a specific nucleotide (e.g., A) at a specific genomic position (e.g., position 11,272 on chromosome 1)?’’ and the beacon server can answer ‘‘yes’’ or ‘‘no.’’ Beacons are intended to be easily set up and to allow data sharing while protecting participant privacy. By providing only allele-presence infor- mation, beacons are safe from attacks that require allele fre- quencies.

However, a privacy breach from a beacon would be troubling given that beacons often summarize data with a particular disease of interest. For instance, identifying that a given genome is part of the SFARI beacon, which contains genomic data from families with a child affected by autism spectrum disorder, means that the individual belongs to a family where some member has autism spectrum disorder. Thus, beacons could leak not only membership information but also phenotype information. Although genetic privacy is protected to some extent by the Genetic Information Nondiscrimination Act (GINA), the offered protections are limited, and GINA does not apply to long-term care insurance, life insurance, disability insurance, or other special cases.

Therefore, all data-sharing mechanisms, including beacons, must protect participant privacy. To examine the question of re-identification in a beacon, we have developed a likelihood-ratio test (LRT) that uses allele presence or absence responses from a beacon to predict whether a given individual genome is present in the beacon database. Our approach is independent of allele fre- quencies. The statistical properties of the LRT guarantee that it is the most powerful test for this problem. A variation of our LRT can detect relatives of the query individual in the beacon. Our results suggest that anonymous-access beacons do not protect individual privacy and are open to re-identification attacks. As a result, they can also disclose phenotype information about individuals whose genomes are present in the beacon.

 'On Non-cooperative Genomic Privacy' by Mathias Humbert, Erman Ayday, Jean-Pierre Hubaux and Amalio Telenti in FC 2015: Financial Cryptography and Data Security (Springer, 2015) 407-426 comments

 Over the last few years, the vast progress in genome sequencing has highly increased the availability of genomic data. Today, individuals can obtain their digital genomic sequences at reasonable prices from many online service providers. Individuals can store their data on personal devices, reveal it on public online databases, or share it with third parties. Yet, it has been shown that genomic data is very privacy-sensitive and highly correlated between relatives. Therefore, individuals’ decisions about how to manage and secure their genomic data are crucial. People of the same family might have very different opinions about (i) how to protect and (ii) whether or not to reveal their genome. We study this tension by using a game-theoretic approach. First, we model the interplay between two purely-selfish family members. We also analyze how the game evolves when relatives behave altruistically. We define closed-form Nash equilibria in different settings. We then extend the game to N players by means of multi-agent influence diagrams that enable us to efficiently compute Nash equilibria. Our results notably demonstrate that altruism does not always lead to a more efficient outcome in genomic-privacy games. They also show that, if the discrepancy between the genome-sharing benefits that players perceive is too high, they will follow opposite sharing strategies, which has a negative impact on the familial utility.

'Family tree and ancestry inference: is there a need for a ‘generational’ consent?' by Susan E. Wallace, Elli G. Gourna, Viktoriya Nikolova and Nuala A. Sheehan in (2015) 201516 BMC Medical Ethics87 comments

Genealogical research and ancestry testing are popular recreational activities but little is known about the impact of the use of these services on clients’ biological and social families. Ancestry databases are being enriched with self-reported data and data from deoxyribonucleic acid (DNA) analyses, but also are being linked to other direct-to-consumer genetic testing and research databases. As both family history data and DNA can provide information on more than just the individual, we asked whether companies, as a part of the consent process, were informing clients, and through them clients’ relatives, of the potential implications of the use and linkage of their personal data. 

Methods 

We used content analysis to analyse publically-available consent and informational materials provided to potential clients of ancestry and direct-to-consumer genetic testing companies to determine what consent is required, what risks associated with participation were highlighted, and whether the consent or notification of third parties was suggested or required. 

Results 

We identified four categories of companies providing: 1) services based only on self-reported data, such as personal or family history; 2) services based only on DNA provided by the client; 3) services using both; and 4) services using both that also have a research component. The amount of information provided on the potential issues varied significantly across the categories of companies. ‘Traditional’ ancestry companies showed the greatest awareness of the implications for family members, while companies only asking for DNA focused solely on the client. While in some cases companies included text recommending clients inform their relatives, showing they recognised the issues, often it was located within lengthy terms and conditions or privacy statements that may not be read by potential clients. 

Conclusions 

We recommend that companies should make it clearer that clients should inform third parties about their plans to participate, that third parties’ data will be provided to companies, and that that data will be linked to other databases, thus raising privacy and issues on use of data. We also suggest investigating whether a ‘generational consent’ should be created that would include more than just the individual in decisions about participating in genetic investigations.

Public Health Messages

The Tasmanian Health Minister has sent a brave and positive public health message through a proposal to raise the minimum legal smoking age to 21 or even 25.

The Minister announced "an ambitious goal for Tasmania to have the healthiest population in Australia by 2025", commenting

Addressing Tasmania’s high rates of chronic disease and health and risk factors such as smoking, obesity, poor nutrition, low physical activity levels and risky alcohol consumption is a priority of our draft Consultative Healthy Tasmania Five Year Strategic Plan. 

The announcement states

The Consultation Draft outlines that smoking and obesity will be priorities under the first five year strategic plan. This is where evidence tells us we can make a significant change in population health outcomes.

The Government has included ideas on improving nutrition and access to healthy food, improving physical activity and recreational infrastructure, developing community-led action plans and taking a ‘life stages’ approach of developing healthy habits in kids and supporting older people to remain healthy and independent.

The Consultation Draft also proposes raising the minimum legal smoking age. Current laws make it illegal to smoke under the age of 18; but there would be significant health benefits associated with raising the legal age to 21 or 25.

International evidence supports raising the minimum legal smoking age as a means of targeting the most at-risk age category for smoking uptake. Studies show that most smokers take up the habit before the age of 25. There would likely be significant health benefits for the community and savings to the health system over time if the rate of people taking up smoking was reduced. 

The draft Plan [PDF] indicates

Potential Future Initiatives To Target Smoking

Tobacco smoking is one of the most serious public health challenges we continue to face as a society, despite substantial progress in recent decades. The Government is committed to thinking boldly about how we can better address this challenge.

The Tasmanian Government sees a clear need to target the smoke free message and related programs if we are going to significantly reduce rates of smoking.

The focus should be on reducing uptake of smoking amongst young people, smoking during pregnancy and reducing smoking rates. This is also an active agenda for QUIT Tasmania at the Cancer Council, the Heart Foundation Tasmania, PHT and the Tobacco Control Coalition. Earlier in 2015, the Government commissioned a Discussion Paper, Options for a Public Health Response to e-Cigarettes. A report has been prepared for the Tasmanian Government based on that feedback, which will be considered as part of development of the final Healthy Tasmania Strategic Plan.

Current smoking statistics

The National Drug Strategy Household Survey 2013, in comparing smoking rates of differing age groups based on self-reported data, found that 3.4 per cent of 12-17 year olds in Australia are daily smokers. Amongst 18-24 year olds, 13.4 per cent reported themselves to be daily smokers. This represents a 10 per cent increase – the largest increase between successive groups across the entire age spectrum.

Tasmania’s statistics are stark - in 2011-12, over 30 per cent of young Tasmanians aged 18-24 years were current (daily or occasional) tobacco smokers, compared with about 7 per cent of older Tasmanians aged 65 years and over. Further, in 2013, 15.1 per cent of all mothers and 33.4 percent of teenage mothers smoked. Only 1.5 per cent of women who reported smoking during the first 20 weeks of pregnancy did not report smoking during the second 20 weeks.

Tobacco smoking is recognised as one of the largest preventable causes of death and disease in Australia. In 2004-2005, smoking was estimated to cost the country around $31.5 billion in social and economic costs, including to the health care system. During the same period, smoking resulted in over 750,000 days spent in hospital and $670 million in hospital costs

Smoke-free generation

The Hon. Ivan Dean MLC first tabled the Public Health Amendment (Tobacco Free Generation) Bill in late 2014 in the Legislative Council. This has led the way on innovative thinking about how to better address the challenge of reducing smoking rates. The Government commends the intention of that Bill, as any initiative aimed at reducing smoking rates is laudable. However, the Government has consistently held concerns about its complexity and likely efficacy, which has prompted bold thinking about how we could achieve significant reductions in smoking rates in a practical, less complex way.

Potential Future Initiative No 6:

Smoking cessation in pregnancy improves the health of the unborn child. A Non-Government Organisation partners with a Primary Health Network and the Tasmanian Health Service on a program to reduce smoking rates in pregnancy. ccccccc The program identifies all women who are smoking at the diagnosis of the pregnancy and provides brief intervention in general practice, strengthens smoking cessation skills in doctors and midwives in antenatal clinics, and uses the patient information management system to ensure that clinical guidelines regarding smoking cessation in pregnancy are systematically implemented.

Such nudging is unlikely to attract major criticism. There will be more debate about raising the smoking age -

Potential Future Initiative No 7: Raising the Minimum Legal Smoking Age

Extending the Minimum Legal Smoking Age (MLSA) beyond 18 through amendment to the Public Health Act 1997 could provide an opportunity to enact some far-reaching change. While it would be a national first, there is international research and practical evidence to support that increasing the smoking age and preventing uptake of smoking can lead to significant reductions in smoking rates with positive life-time effects.

Evidence for raising the MLSA

In 2015, the US Institute of Medicine (IoM) released an extensive report investigating the likely efficacy of increasing the national MLSA. The study reported that approximately 90 per cent of adult daily smokers in the US reported their first use of cigarettes before reaching 19 years of age, while almost 100 percent begin before the age of 25. It used mathematical modelling to estimate the relative effect of raising the MLSA from 18 to 19, 21 or 25.

The researchers concluded that if the MLSA were raised now, by the time today’s teenagers reached adulthood, within that cohort there would be a 3 per cent overall reduction in smoking prevalence if the MLSA were raised to 19, a 12 per cent overall reduction in smoking prevalence if raised to 21 and a 16 per cent overall reduction in smoking prevalence if raised to 25. These benefits would presumably carry through over time as a greater proportion of the population had been subject to such a law.

In 2015, Hawaii became the first US state to pass legislation to raise the MLSA to 21, which will take effect from 1 January 2016. Similar debates have recently been taking place at the state level in Washington and California.

While it may take some time before the full impact on smoking rates in Hawaii is able to be measured, a number of other US municipalities and counties have also raised the MLSA to 21, including New York City. The first city to do so was Needham, Massachusetts in 2005. Data from Needham showed that following this, tobacco use among high school students was reduced almost by half, and the rate of frequent tobacco use fell by 62 per cent – significantly faster than surrounding areas.

In the IoM study, one of the models used projected that if the MSLA were raised to 21 across the United States, there would be approximately 223,000 fewer premature deaths, 50,000 fewer deaths from lung cancer and 4.2 million fewer years of life lost for those born between 2000 and 2019.

Practical considerations

Any move to increase the MLSA in Tasmania would need to consider how to treat those within the relevant age cohort who are currently legally able to smoke at present, as well as those currently underage but who will attain majority before any change came into effect. One option would be to enact transitional arrangements for a defined period in order to promote and socialise new arrangements. However, the extent to which any agreed increase to the MLSA is delayed would represent continued increased risk of smoking addiction to the relevant age cohort.

There is also the matter of how such a law should treat international and interstate tourists coming to Tasmania under a higher MLSA. We need to consider whether tourists should be required to observe Tasmanian laws, as is the case with other laws which differ from other jurisdictions, or whether they might be exempted for purchasing and/or possession and use.

There is also the matter of what impact such a law may have on retailers. We can assume that there may be an initial modest impact on retail trade, which could increase over time with progressive decreases in overall smoking rates. Having a transitional or ‘phase-in’ period may have the added benefit of allowing businesses time to model and adjust for any anticipated impact on trade.

The draft accordingly asks several questions

Do you support increasing the minimum legal smoking age to 21? If so, do you support a phase- in arrangement with respect to those currently legally able to smoke in the 18-20 age cohort?

Do you support increasing the minimum legal smoking age to 21, and subsequently increasing it to 25 later, based on evidence of impact?

Do you support increasing the minimum legal smoking age to 25? If so, do you support a phase-in arrangement with respect to those currently legally able to smoke in the 18-24 age cohort?

What impact would there be on tourists and visitors to the State in increasing the minimum legal smoking age and how could these be alleviated?

Do you support maintaining the status quo? If so, what are the reasons?

US Genetic Discrimination and Objectivity

'How Genetics Might Affect Real Property Rights' by Mark and Laura Rothstein in (2016) 44(1) Journal of Law, Medicine and Ethics comments

New developments in genetics could affect a variety of real property rights. Mortgage lenders, mortgage insurers, real estate sellers, senior living centers, retirement communities, or other parties in residential real estate transactions begin requiring predictive genetic information as part of the application process. One likely use would be by retirement communities to learn an individual’s genetic risk for Alzheimer’s disease. The federal Fair Housing Act prohibits discrimination based on disability, but it is not clear that it would apply to genetic risk assessments. Only California law explicitly applies to this situation and there have been no reported cases.

'The Emperor’s New Genes: Science, Public Policy, and the Allure of Objectivity' by Ruha Benjamin in (2015) 661 Annals of the American Academy of Political and Social Science 131-142 addresses

the politics of genomics through three diagnoses: The first, diagnosing objectivity, discusses how researchers involved in a large-scale population mapping initiative distinguish genomics as relatively objective, compared to other forms of knowledge production. The second case, diagnosing nationality, examines an attempt by the UK Border Agency to use genetic ancestry testing to vet asylum claims. The third case, diagnosing indigeneity, considers how indigenous councils in southern Africa engage genomic science in their struggle for state recognition and rights. I argue that genomics’ allure of objectivity lends itself to such diagnostic attempts among both powerful and subaltern social actors and suggest that developing “technologies of humility” may provide one safeguard against the increasing uptake of genomics as the authority on human difference.

 Benjamin comments

The specter of state-sanctioned eugenics can serve as a distraction from more routine, seemingly benign or even beneficent, scientific practices that are taken up in the policy arena. When attention is focused too narrowly on eugenic boogiemen, genomic saviors that seem to tell us a more true and complex story of population history, may elude critical analysis. A moratorium on the binary between good versus bad science as a mode of popular and scholarly critique is necessary, because the distinction sidesteps how much of what we deem as “bad” today was produced by respected researchers based in prominent institutions of the time. The normative distinction causes observers and analysts alike to be wary of practices that appear obviously bad and are often sensationalized (e.g., Tuskegee syphilis experiment), while overlooking normal workaday science produced with the help of multi-million-dollar grants by award-winning researchers vetted through peer-review. Although the critical response by the population genetics community towards A Troublesome Inheritance (2014a) by Nicholas Wade was celebrated by many who have been calling for greater reflexivity in the field, it underscores this binary: a letter signed by more than 130 researchers said that Wade had “misappropriated” their research to “support arguments about human societies” as it relates to IQ, political institutions, and economic development.  Certainly, misuse is an issue, but what also seems to fuel the uptake of genomics in support of such claims is the field’s allure of objectivity.

The hazards of workaday genomics, I suggest, have more to do with this allure than with its potential to construct hierarchies of superior and inferior groups. In this context, focusing on proponents of biological determinism a la Wade may serve as a distraction from the dexterity of genomics, in which different social actors draw on its diagnostic allure to make authoritative claims about group boundaries.

In framing this discussion as a set of interconnected processes of diagnosis, I draw on work that challenges the use of genetic ancestry testing as a diagnostic of group membership. For example, Bolnick et al.’s (2007) caution that

when an allele or haplotype is most common in one population, companies often assume it to be diagnostic of that population. This can be problematic because high genetic diversity exists within populations and gene flow occurs between populations. Very few alleles are therefore diagnostic of membership in a specific population, but companies sometimes fail to mention that an allele could have been inherited from a population in which it is less common. (p. 400, emphasis added)

While the critique above is directed at the private sphere (i.e., companies that capitalize on the willingness of consumers to pay for testing), the discussion here is concerned with how such tests are taken up in public policy where the parameters of political and social inclusion are being established or challenged. In the process of diagnosing group membership, genomic tools are deployed by varied social actors to make competing claims about who belongs and who does not. Extending Pollock’s (2012) application of the Derridean concept of pharmakon to race-based medicine—as both remedy and poison—the discussion here illustrates the normative dexterity of genomic claims in public policy (Benjamin 2015). It draws three examples together through the idiom of diagnosis, to con-ceptualize the connection between the authoritative representation of the field and its political circulation. The first case, diagnosing objectivity, discusses how representations of a large-scale population mapping initiative distinguish the objectivity of genomics from other forms of knowledge production. The second case, diagnosing nationality, examines an attempt by the UK Border Agency to use genetic ancestry testing to vet asylum claims. The third case, diagnosing indigeneity, considers how indigenous councils in southern Africa engage genomic science in their struggle for state recognition and rights. I argue that the field’s allure of objectivity lends itself to such diagnostic attempts by powerful and subaltern social actors alike. Finally, I suggest that developing “technologies of humility” (Jasanoff 2007) may provide one safeguard against the increasing uptake of genomics as a means to arbitrate the parameters of political and social inclusion.

In discussing the 'diagnosis of nationality' [p 134] Benjamin states

In 2009, the UK Border Agency (UKBA) initiated the Human Provenance Pilot Project (HPPP), with the aim of using genetic ancestry testing and isotope analysis to vet asylum claims. If, over the course of a standard interview, caseworkers grew suspicious of an applicant’s story, they would request samples of saliva, nails, and hair. The primary targets of the project were East Africans. Somali applicants escaping persecution were eligible for asylum, so if the tests indicated someone was from Kenya—a phenomenon dubbed “nationality swapping”—he or she was scheduled for deportation. The entire process was essentially an experiment. Yet over the course of the project, actual cases were vetted using these methods. A letter from the deputy director of the project, Phil Douglas, stated that “all samples will be provided voluntarily,” but caseworkers were encouraged to regard refusal to submit samples with suspicion. The official protocol instructed:

If an asylum applicant refused to provide samples for the isotope analysis and DNA testing the case owner could draw a negative inference as to the applicant’s credibility. … There must be other compelling evidence which also clearly demonstrates that the applicant has attempted to conceal information or mislead the UK Border Agency. It must not be stated within the RFRL [Reasons for Refusal Letter] in isolation and must certainly not be stated as a primary reason for refusing the applicant’s asylum claim.

Following the protests of refugee advocates and the work of journalist John Travis—and not through any regulatory or oversight governing body—the project came under widespread scrutiny. In the process, academic scientists expressed shock and disgust, insisting that the techniques used could not diagnose nationality in the way that the project assumed. David Balding, a population geneticist at Imperial College London, noted that “genes don’t respect national borders, as many legitimate citizens are migrants or direct descendants of migrants, and many national borders split ethnic groups” (Travis 2009).

Mark Thomas, a geneticist of University College London, who called the HPPP “horrifying,” contended that determining a person’s ancestry—as distinct from nationality—is more problematic than many believe. “[Mitochondrial] DNA will never have the resolution to specify a country of origin. Many DNA ancestry testing companies have sprung up over the last 10 years, often based on mtDNA, but what they are selling is little better than genetic astrology,” he said. “Dense genomic SNP data does have some resolution … but not at a very local scale, and with considerable errors” (Travis 2009). Likewise, Alec Jeffries, one of the pioneers of human DNA fingerprinting, wrote,

The Borders Agency is clearly making huge and unwarranted assumptions about population structure in Africa; the extensive research needed to determine population structure and the ability or otherwise of DNA to pinpoint ethnic origin in this region simply has not been done. Even if it did work (which I doubt), assigning a person to a population does not establish nationality—people move! The whole proposal is naive and scientifically flawed. (Travis 2009)

An isotope specialist at Durham University, Janet Montgomery, explained that “unless the border between Somalia and Kenya represented some major geological or hydrological division, I cannot see how isotopes will discriminate between people living there let alone living at/on the border” (Silverstein 2011). Montgomery specified, “Isotopes do not respect national borders or convey some inherent national attribute. They are not passports” (Silverstein 2011).

Despite such severe criticism from the scientific community, the HPPP did not initially shut down; nor did it rule out the possibility that it would reintroduce a similar initiative in the future. In their own defense, representatives of the Border Agency insisted that only asylum-seekers who had already failed linguistic tests (another contested method of determining nationality) would be asked to provide mouth swabs, hair, and nail samples. It also released the following written response to scientific criticisms:

Ancestral DNA testing will not be used alone but will combine with language analysis, investigative interviewing techniques and other recognized forensic disciplines. The results of the combination of these procedures may indicate a person’s possible origin and enable the UKBA to make further enquiries leading to the return of those intending on abusing the U.K.’s asylum system. This project is working with a number of leading scientists in this field who have studied differences in the genetic backgrounds of various population groups. (Travis 2009, emphasis added)

Several prominent scientists, who had been interviewed by Travis, said they suspected that private labs that were under much less regulatory oversight had been involved in the project. And while the UKBA has since tried to downplay the significance of the project, in the words of Pearson, “It’s peoples’ lives we’re dealing with.”

The idea that the HPPP was voluntary conceals the threat of deportation if applicants did not consent to testing. It is coercive to say one has a choice, when one of those choices is automatically penalized. As Tutton, Hauskeller, and Sturdy (2014) explain, “In the UK, official and popular attitudes to those who request sanctuary have become dominated by a hermeneutic of suspicion. Public and policy discourses portray asylum seekers as mostly ‘bogus’ refugees seeking admission to the country for economic, not humanitarian, reasons” (p. 739).

The quest for scientific tools to determine ancestry and arbitrate group mem-bership continues apace toward a variety of political and biomedical ends. The near uniform criticism on the part of scientists toward the UK project serves to highlight a key feature of the underlying science—its refusal to adhere to “terms of use” in so far as the UKBA was unwilling to completely shut down the project. Furthermore, essential for this discussion is that

such technologies of identity do not simply offer more objective means of confirming or disconfirming conventional identity claims. They actually redefine the social categories of identity on which immigration and asylum decisions are based. … The HPPP stands as a salutary warning of the ways in which supposedly objective technologies of identifi-cation are increasingly being used at international borders as a way of further disempow-ering the already vulnerable. (Tutton, Hauskeller, and Sturdy 2014, 749)

But due to the dexterity of the field, supporting as it does competing ideas about peoplehood and belonging, it has also been enrolled in initiatives that seek to empower groups that have been historically dispossessed, as the next section illustrates. The latter, as I argue, should attract as much careful analysis as the HPPP, because of the way that the authority of genomics may displace other forms of group-making and political mobilization.

Outsourcing Surveillance

'Outsourcing, Data Insourcing, and the Irrelevant Constitution' by Kimberly N. Brown in (2015) 49(3) Georgia Law Review comments

Once the stuff of "paranoid fantasy,"· the era of ubiquitous government surveillance has arrived in large part due to the expansion of advanced technology and bulk data in private hands. Gone are the days in which cutting-edge clandestine surveillance was conducted through direct-yet relatively exceptional-methods like court ordered wiretaps. The government now carries out much of its surveillance by applying mathematical algorithms to huge sets of data that customers willingly turn over to third-party sources such as Verizon and Google. Privately-sourced phone, e-mail, and IP address information is then paired with so-called "enrichment data" from Facebook, credit card companies, airline manifests, voter registration rolls, GPS devices, aerial and closed-circuit camera photos, facial recognition systems," embedded microchips, and web-tracking technologies to create intimate personal dossiers of unsuspecting individuals who have broken no laws.

Such data insourcing for purposes of surveillance is of a piece with the government's widespread practice of outsourcing sovereign responsibilities to third parties through service contracts and other devices that effectively transfer public power to private hands. In both circumstances, existing law is not up to the task of ensuring that government officials remain accountable to the populace for sponsored activities. Statutory surveillance law and Fourth Amendment doctrine were crafted in the pre-digital age, when unconsented monitoring by the government was the greatest threat to privacy. Yet today, private industry parses and stores personal information on a scale that is exponentially greater than that which the government can aspire to on its own. The government capitalizes on such troves of private sector information for its own surveillance. It also hires private parties for military combat operations, nuclear weapons management, municipal policing, prison administration, policy planning and rulemaking, public benefits determinations, international relations work, and its own personnel management.

Because the Constitution only applies to state action, the government's use of private sources to conduct its work evades constitutional barriers that would otherwise operate to ensure accountability to the people. Outsourcing and data insourcing occupy what amounts to a pocket of constitutional immunity as an accident of doctrinal shortsightedness." Numerous scholars have outlined legislative proposals for addressing private sector involvement in government practices. This Article seeks to establish that, in spite of the many shortfalls in prevailing doctrine, recognition of constitutional limits on the government's use of insourcing and outsourcing to perform sovereign functions is - or should be - inexorable. Such limits can be derived from the Constitution's structure, which assumes that the government remains ultimately accountable to the people for the exercise of its functions. With an eye towards creative litigation, this Article recasts state action, private delegation, and Fourth Amendment doctrine in ways that enable judicial review of whether the government has structured its outsourcing and data insourcing.

Disability

In Ingram v QBE Insurance (Australia) Ltd (Human Rights) [2015] VCAT 1936 the Victorian Civil and Administrative Tribunal has dealt with a claim of direct discrimination regarding the provision of services based on the inclusion of a mental illness exclusion in a travel insurance policy and regarding provision of services when indemnity was denied in reliance on a mental illness exclusion in a travel policy.

The VCAT decision is specific to the particular claims and should be read with care.

The report states

In late 2011, during the course of her year 11 studies, Ms Ella Ingram and her mother decided she could join a school tour to New York scheduled for 30 March to 11 April 2012. The required deposit and subsequent instalments were all paid. Some of the costs were applied to a travel insurance policy issued by QBE Insurance (Australia) Ltd (QBE) on 8 December 2011.

In about January 2012, for the first time in her life, Ms Ingram experienced symptoms of depression. Over the course of the following months she was diagnosed with that illness and received treatment. In consultation with her doctors and mother, Ms Ingram decided not to go on the planned school trip, in the interests of her health.

In about April 2012, Ms Ingram’s mother made enquiries about claiming the cost of the trip on the QBE policy. The claim for $5,860 was lodged in May 2012 and was denied by QBE on 17 August 2012. The refusal was confirmed by a further letter sent on 4 December 2012.

In rejecting the claim, QBE relied upon a general exclusion that said, in summary, there is no cover where the claim arises directly or indirectly due to mental illness. There is no dispute that the definition of mental illness in the policy includes depression. In its 4 December 2012 correspondence to Ms Ingram’s mother, QBE said that the decision to refuse the claim was based on detailed statistical modelling and analysis of claims arising from a range of causes including mental illness. QBE said that mental illness is excluded from the policy because its statistics demonstrated that in travel policies there is a high risk of cancellation because of mental illness.

Ms Ingram said by including the mental illness exclusion in the policy, QBE treated her unfavourably because of her disability and directly discriminated against her in the terms on which it provided the service of travel insurance. Ms Ingram said that conduct was a breach of section 44(1)(b) of the Equal Opportunity Act 2010 (Vic) (EOA). Ms Ingram further said that, by refusing to indemnify her in August and December 2012 on the basis of her mental illness, QBE treated her unfavourably because of her disability and so directly discriminated against her contrary to section 44(1)(a) of the EOA.

Ms Ingram has sought a declaration that QBE unlawfully discriminated against her, compensation for economic loss and the damage of hurt and humiliation suffered by her and costs. The economic loss claimed is $4,292.48 which takes account of a flight costs refund. Ms Ingram sought $20,000 in compensation for hurt and humiliation.

QBE denied discriminating against Ms Ingram. In its defence it said that it did not refuse to provide insurance to Ms Ingram because of her disability. Rather, the policy wording contained an exclusion for mental illness. [1] Further or alternatively, QBE said that, if it did discriminate against Ms Ingram in either of the ways alleged, that discrimination was lawful because an EOA and/or a Disability Discrimination Act 2004 (Cth) (DDA) exception applied.

 In its summary VCAT (single member) states

At the relevant points in time, Ms Ingram had a ‘disability’ within the meaning of that term in the EOA;

QBE engaged in direct discrimination in breach of section 44 of the EOA first, when it issued her with a policy which included the mental illness exclusion and second, when it refused her indemnity relying on the terms of that exclusion;

QBE cannot rely upon the statutory exceptions to excuse the discrimination. That is because QBE has not produced evidence to prove it is more probable than not that:

• At the relevant points in time, the acts of discrimination by QBE were based on actuarial or statistical data. I have found I cannot infer otherwise. Accordingly, the exception contained in section 47(1)(b) of the EOA and section 46(2)(f) of the DDA which depend on such data do not apply;

• It would have suffered unjustifiable hardship if it had not included the mental illness exclusion in the policy issued to Ms Ingram. Accordingly, the exception contained in section 29A of the DDA does not apply;

As a consequence, QBE engaged in unlawful discrimination when it included the mental illness exclusion in the policy issued to Ms Ingram and when it denied her indemnity relying on that exclusion;

Ms Ingram is entitled to economic loss in the sum of $4,292.48, being the value of her cancelled trip;

Ms Ingram is entitled to non-economic loss in the sum of $15,000 for hurt and humiliation; and Ms Ingram is entitled only to the costs associated with her expert being required for one additional day.

Importantly, VCAT states

Ms Ingram applied for a declaration that QBE had engaged in unlawful discrimination.

I have declined Ms Ingram’s application to ensure that an impression is not given that my decision automatically applies beyond the dispute between these parties and, in particular, to avoid any impression that it applies to all insurers.

GMO Bugs

The House of Lords Science and Technology Committee has released its upbeat report on Genetically Modified Insects, stating

The problems caused by infectious disease and agricultural pests are real. Genetically modified (GM) insects have the potential to address both these problems. The UK is a world leader in the development of this technology. The European Union’s regulatory process, however, is likely to hold back progress. There is a moral duty to test the potential of the technology. We therefore support further research and call for action to test the efficiency of the EU process via a trial which should also be used to drive public engagement.

The world’s fastest growing insect-borne disease is dengue. The global incidence of dengue has grown dramatically in recent decades and about half of the world’s population is now at risk. Dengue can be found in tropical and sub-tropical climates across the world. The possibility of an outbreak of dengue, however, now exists in Europe. This mosquito-borne viral infection causes a flu-like illness, and can develop into a potentially lethal complication named severe dengue. Severe dengue is a leading cause of hospitalization and death among children in many Asian and Latin American countries. A recent study estimated there to be 390 million dengue infections per year.

In 2015 there have been approximately 214 million cases of malaria and 438,000 deaths. Sub-Saharan Africa is particularly affected; so far this year, the region has been home to 89% of malaria cases and 91% of malaria deaths. Malaria is both preventable and curable, and increased efforts have seen significant reductions in malaria incidence (the rate of new cases) and deaths. Nevertheless, about 3.2 billion people, nearly half of the world’s population, live in countries, territories and areas where malaria is endemic.

By 2050 the world’s population will likely increase by more than a third to over 9 billion people. World food production will be required to increase by 70% to feed this larger, more urban and richer population. Insect pests affect all aspects of food production, storage, transport and waste. Agricultural losses due to insect damage are high. For example, insect pests cause an average annual loss of 7.7% in production in Brazil, a reduction of approximately 25 million tons of food, fibre and biofuels, with total annual economic losses reaching around US$ 17.7 billion. Insect-borne diseases also have a heavy impact on livestock. Research conducted at the Pirbright Institute in the UK prevented Bluetongue disease becoming endemic in UK sheep and cattle, an estimated saving to the UK economy of £480 million in 2008 alone.

The development and use of GM insects offers significant potential for both the control of infectious diseases and the management of agricultural pests. It is possible to manipulate an insect’s DNA in order to alter its function or reduce its fitness. In this way, insects which transmit diseases or damage crops can be modified. GM insect technologies are a potential form of biological control, in contrast to the use of chemical controls, such as insecticides, which can be harmful to people and the environment.

GM insect technology has already been trialled for dengue transmitting mosquitoes. Developed by the UK company Oxitec Ltd., field evaluations have seen a >90% reduction in numbers of the target species in the Cayman Islands and a 96% reduction in Brazil, which is argued to be sufficient to prevent endemic dengue fever anywhere in the world. From the evidence we heard, it may be the case that GM insect technology is more suited to tackling dengue than malaria.

In November 2015, scientists announced that they had successfully used GM insect technology so that a modified mosquito passes on genes conferring resistance to a pathogen (an organism that causes disease) to almost all of its offspring, not just half, as would normally be expected. This offers the possibility of a gene resistant to the parasite that causes malaria being able to spread quickly through a wild population of mosquitoes. In early December 2015, scientists, including Professor Austin Burt who gave oral evidence to our inquiry, announced findings that could speed up the development of techniques to suppress mosquito populations to levels that would not support malaria transmission.

The potential of GM insect technologies, however, should not be over-stated; an arsenal of strategies is required to tackle insect-borne diseases and crop pests. GM insect technologies do not represent a panacea. They are one of a number of experimental techniques being investigated in order to control insect-borne diseases and reduce agricultural pests.

Nevertheless, despite inevitable uncertainties, we conclude that GM insect technologies should be afforded an opportunity to play a complementary role in helping to meet the global challenges of disease control and food security. The UK, moreover, is a world leader in this area and hosts the only company in the world producing and distributing GM insects (Oxitec Ltd.). Unfortunately, we are very concerned that the benefits offered by GM insects may not be realised. The EU regulatory regime for genetically modified organisms (GMOs) is not functioning effectively. Although no EU-level GM insect applications have been received to date, the regime has seen many applications for GM crops. In these cases, the regime is failing lamentably. The prescribed process is not being followed and the system is gridlocked. Strenuous efforts must be made to ensure that the system operates more efficiently and that future GM insect applications are not stymied unnecessarily. To this end, the UK Government must bring pressure to bear on the European Commission to ensure that the current regime works as intended.

However, ensuring that the current system works as intended is not sufficient. The EU regulatory regime does not take into account the benefits of a technology; regulation is entirely on the basis of risk. Any rational approach to deciding whether or not to pursue a given technology should include an assessment of its net benefits. At the moment, moreover, no consideration is given to the risks of alternatives to the GM application. A potential new GM insect technology to reduce an agricultural pest population, for example, would not be compared alongside the insecticide currently used to tackle the pest. As such, GMOs are effectively considered against an idealised, risk-free alternative. For many GM insect technologies, the alternative may present a number of risks and problems, and, in many cases, such risks and problems (the use of insecticides for instance) may be the imperative behind the development of the GM insect technology in the first place. Consideration of the benefits of a technology, and acknowledgment of the control methods currently in use, should be incorporated into the regulatory regime in order to address this illogical situation.

In order to attempt to break the current impasse, we recommend that the Government invests in a GM insect field trial to test fully the science of GM insects, regulatory processes and policies. This stimulus is required in order to move beyond the current stasis induced by the failings of the EU regulatory regime. Moreover, the pursuit of such a trial should be the catalyst for a public engagement exercise. It is imperative that the public is given the opportunity to understand the development of GM insect technologies in a transparent way so that the polarised debate which has enveloped GM crop technologies is avoided.

GM insect strategies for agricultural use are likely to have greater scope for application within the EU, though there may be future uses for public health purposes that could be applicable in Europe. In all likelihood, however, the main uses of GM insect technologies, particularly for public health purposes, will occur outside the EU. In this regard, we are concerned that the application of GM insect technologies in the countries whose need is greatest may be affected by a lack of international guidance and leadership on the governance and regulation of these technologies. We therefore recommend that the Government, in light of its strong commitment to international development, actively considers how these challenges of international guidance and leadership can be fully achieved.

The application of GM insect technology, together with advances in the broad area of biotechnology, has the potential to provide additional tools for the control of insect-borne diseases and crop pests. The conceivable prize is enormous and the opportunity must not be squandered. Our concern is that unless there is change, and an injection of momentum and urgency, it will be.

The report goes on to refer to "a bleak picture", stating

The process for GM crops is clearly failing lamentably. It is not working as intended. The new national derogations for commercial cultivation of GM crops, referred to by the Minister, are to be broadly welcomed as a potential means of breaking the gridlock, but only time will tell if they can have any effect.

Concerns expressed about the regulatory regime were voluminous, and extended beyond poor implementation, and the vagaries outlined by the Minister, to fundamental misgivings about the design of the regime. We heard repeatedly, from nearly all parties involved, that the system does not work as intended and is subject to excessive political interference once the scientific risk assessment has been completed by EFSA. Policy-makers should not ignore the scientific evidence base.

Further concerns highlighted to us also included: regulation was not designed with GM insect technologies in mind, but is rather an extension of the legislation for GM crops; regulation is entirely on the basis of risk, and benefits are not considered; the process is regulated rather than the product generated; and self-limiting population replacement strategies are considered in the same way as self-perpetuating population replacement strategies.

In the paragraphs that follow, we briefly catalogue the litany of criticism that was directed towards the regulatory regime. As Dr Jack Stilgoe, Senior Lecturer at the Department of Science and Technology Studies, University College London, put it to us: “I am afraid it is one of those situations where you could say ‘you wouldn’t start from here’.” We agree, but we have, of course, no choice, and if the potential of GM insects is to be realised, then urgent actions are required.

As we have noted, the regulatory regime covers all GMOs including both GM crops and GM insects. Although it does remain to be seen if GM insect applications would be subject to regulatory difficulties resulting from part C of directive 2001/18/EC, all the experience of GM crops would seem to point to it. Professor Rosemary Hails, Chair, Advisory Committee on Releases to the Environment (ACRE), stated: “in the EU we do not have a functioning system for GM crops.”83 Camilla Beech, Head of Regulatory Affairs at Oxitec Ltd., gave a clear view from the commercial sector: “As an applicant we believe that the European system does not work because it is just not predictable. You put an application in and you can never predict when you are going to receive a response. That is bad for innovation and it is bad for companies.”84 100.Innovate UK stressed that the deliberate release directive had not been designed with GM insect technologies in mind, but was rather an extension of the legislation for GM crops: “The current regulations pre-date the existence of GM insects and do not seem to effectively accommodate this technology.”85 George Eustice MP, however, disputed the view that the currently regulatory regime could not effectively accommodate GM insect technologies: “from a regulatory point of view, we do not see any reason why the GM process that exists for crops in the EU should not equally be applied to GM insects.”86 101.We heard repeatedly that there is currently no means to consider the potential benefits of GMOs within the regulatory regime. As such, decisions are made entirely on the basis of risk alone. The National Institutes of Bioscience (NIB) stated: “Without considering benefits, one is implicitly comparing the proposed action with a non-existent risk-free alternative—a Utopian fallacy. Benefits, and therefore risk-benefit, could be considered explicitly.”

Furthermore, we were surprised to learn that new technologies are not evaluated alongside alternative means to address the problem. For example, a potential new GM insect technology to reduce an agricultural pest population would not be compared alongside the insecticide currently used to tackle the pest.

The current EU regime operates via a system of process-based regulation. That is to say, the trigger is the process by which a product is made rather than the nature of the product itself. In this regard, Camilla Beech, Head of Regulatory Affairs at Oxitec Ltd., offered the following analogy: “It is like reviewing a book as to whether it has been written on a typewriter or a computer and not on its content.”

This process-based system would consider population replacement and population suppression GM insect strategies in the same way. John Mumford, Professor of Natural Resource Management, Centre for Environmental Policy, Imperial College London, highlighted a fundamental conflict within the current framework when population replacement strategies were considered: “there are seven large areas of technical concern within the deliberate release directive, and persistence is one of those seven. Obviously, with the self-sustaining mode of action for some of these methods, you are starting from an assumption that the whole mode of action is a concern. That is an inherent conflict within the regulation.”  In this way, the deliberate release directive is fundamentally not designed to consider self-perpetuating population replacement strategies.

The criticism directed towards the regulatory regime raises the question of whether the focus should be on making the current system work better, or seeking to overhaul it entirely. Professor Rosemary Hails argued that there would be merit in trying to make the existing system work as it should: “We ought to be proactive on trying to make the current system work more effectively. In essence, we have the evidence that it works more effectively in other countries.”

The current system is framed around the implementation of the Precautionary Principle. On the use of this Principle, Professor Rosemary Hails stated: “the Precautionary Principle properly applied would also take into account the risks of not developing a particular technology and the benefits forgone. It is a misuse of the Precautionary Principle that has led us to this place.”

The Government maintains that the best course of action is to ensure that the regulatory environment works as it is written. George Eustice MP said: “All the EU has to do is not necessarily rewrite its process but just gain some credibility by sticking to the process that it has written down.”

George Freeman MP put it in the following terms: “GM technology is taking off across the world. The question is not whether we are going to stop it; the question is whether we are going to help contribute to leading it and getting the right regulatory framework in place.”

We welcome the Government’s endorsement of the potential of GM technologies and its recognition of the importance of a functioning regulatory environment. We are concerned, however, by its view that the most appropriate course of action is only to ensure that the current system proceeds as it is written. This is not sufficient.

GM insects have the potential to help in the control of both insect-borne diseases and agricultural pests, bringing both public health and economic benefits. The UK is a world leader in the development of GM insect technologies and the public good and the commercial opportunities are tangible. However the current EU regulatory regime for GMOs risks this opportunity being squandered. The regime is failing as applied to GM crops and the full potential of GM insects will not be realised if it continues to fail to function adequately.

We accept that there is some practical merit in the Government’s decision to work to ensure that the existing regulatory regime for GMOs at least functions as written. We ask the Government to set out clearly how it intends to do so and to publish annual updates on progress made in improving the operation of the system, starting in the summer of 2016. However, we do not accept that this is sufficient and we advocate a more radical review of the regulatory framework later in this Chapter.

International regimes

By way of comparison, we explored a number of international (non-EU) regulatory frameworks for GMOs in order to ascertain the characteristics of alternative regulatory regimes. Norway was cited as a notable example. Although a non-EU country, Norway is a member of the European Economic Area (EEA). As a member of the EEA, it has incorporated EU-based regulation but has also included an additional component. Professor Rosemary Hails told us: “Norway has some additional legislation—the Gene Technology Act 1993—where it considers the benefits also of a particular element to the community and the contribution to sustainable development, but that is in addition to the other regulations.”

Outside Europe, we were told that Canada has adopted a regime of trait-based regulation. This is effectively the reverse of the system in the EU whereby process-based regulation is used. Dr Jeremy Sweet, an Environmental Consultant with Sweet Environmental Consultants and member of the EFSA GMO panel, said of the Canadian system: “they do not discriminate GMOs from other types of engineering or manipulation or technologies. They look at the novelty of a product and say, ‘Are we concerned about this and do we need to look at it and regulate it?’”

Oxitec Ltd. highlighted the regulatory environment in Brazil. This regulatory system has been tested, unlike that in the EU, and the Brazilian authorities accepted a trial release of Oxitec GM mosquitoes. Oxitec suggested that this successful release in Brazil was due to “a clear regulatory framework based on plausible scientific pathways to harm and subsequent evaluation allowed the assessment of the dossier for commercial release in approximately 9 months from submission to approval.” From what we heard of the EU regulatory system, such efficiency would seem highly unlikely were a similar application to be received.

Oxitec also highlighted the regulatory environment in the USA where, under the National Environmental Policy Act, agencies are required to issue an Environmental Assessment that takes into consideration the alternatives available alongside the GMO application. Thus, GM insects are not considered against an idealised ‘risk-free’ alternative.

The joint submission received from a grouping of eminent Brazilian scientists—Dr Amaro de Castro Lira Neto, Dr Marcia Almeida de Melo and Professor Paulo Paes de Andrade—also highlighted the US system of regulation. They suggested that the main point of success of the US system is: “the full independence of the risk assessment procedure against the other risk analysis steps, i.e., risk management and risk communication, and ultimately against political decisions.” Furthermore they stressed that: “No political interference is allowed, at least under normal circumstances.”

This independence of the risk assessment procedure from political decision-making presents a stark contrast to the picture painted for us of the EU regulatory system. This group of Brazilian scientists also suggested that this independence is the cause of rapid adoption of biotechnology in Brazil and, to a certain extent, in Argentina, Australia and Canada as well.

Alternative regulatory protocols

We were presented with a number of alternative regulatory models that may allow for more effective incorporation of GM insects into the general GMO regulations. A number of these have been touched on above. Warnings were issued, however, about the pursuit of a new regulatory regime. George Eustice MP stressed to us: “with any European process you always have to be conscious that by taking the lid off things and trying to play around with the wiring, you might end up with something worse. It is a terrible thing to say, but I am afraid there is a track record of trying to tamper with things in Europe that are not quite right, and they end up worse than ever.”

.Although a radical overhaul of the current regulatory process may be unlikely or undesirable at this time, a number of potential alterations to the regulatory process were highlighted to us.

A trait-based approach

A trait-based approach to regulation was raised as a sensible, scientifically-sound alternative to the current process-based regulatory system. In this case, the product, rather than the means by which it has been formed, is considered. This system is in operation in Canada. Professor Rosemary Hails indicated that ACRE would deem this approach to be more scientifically defensible and “more scientifically rational now.” Dr Jeremy Sweet also highlighted that trait-based regulation is a “science-based approach”.

.A move to a trait-based system would allow separate consideration of GM insects created via population suppression and population replacement strategies. It would also result in population suppression approaches such as Oxitec’s genetic-equivalent of the SIT being considered in the same way as traditional irradiation-based SIT approaches. This may be more rational as the nature and implications of the end products are arguably the same; it is simply that the process to create them is different.

Not all the evidence we heard suggested that trait-based regulation is superior to process-based regulation. Dr Jack Stilgoe warned us that there may be good reasons for a process-based system: “They are to do with the uncertainties that we might be unable to predict in terms of the products, whether those are the products themselves or the products of that particular innovation in terms of the consequences and ramifications of those traits, and actually paying attention to the processes might better take you into a precautionary approach to governing those uncertainties.”

New technological developments may be captured within a system of trait-based regulation. For example, both transgenic and cisgenic GMOs would be included. Dr Jeremy Sweet indicated that it is becoming increasingly difficult to draw a distinction between “GM” and “non-GM”. He emphasised to us that: “We are getting into a bigger and bigger mess by basing the regulation around the technology.”

Government Ministers also highlighted to us that new emerging technologies are serving to blur the boundaries between GM and non-GM. However, on the prospect that trait-based regulation could incorporate new (cisgenic) technologies and remove the need for such arbitrary classifications, George Eustice MP stated: “We would not want those [emerging technologies] to be treated as GM, otherwise you are going to hold back the development of a very exciting new area.” He continued: “Once you start talking about trait-based approaches to this, I think there is a danger that you start to tip some of those other novel techniques too closely to the GM regulatory regime, which is the worst of all worlds, because then you have other exciting new technologies that we hope to protect from this and to maintain an understanding that they are not GM, and get muddled up in this unsatisfactory regime as well.”

At present, cisgenic organisms, such as those created using gene-editing techniques, including CRISPR, are not considered within 2001/18/EC. We consider this to be correct. We heed the warning that a move to trait-based regulation would alter this situation. However, while we agree with the Minister that new emerging technologies should not be stifled by a failing regulatory system, we do not think it appropriate to ignore the deficiencies of the regulatory regime for other developing (transgenic) technologies.

We urge the Government to monitor the development of new genetic technologies, including GM insects, in order to ensure that the regulatory regime is fit-for-purpose. We recognise that a move to a trait-based system may not currently be appropriate. We see the risk that a move to a trait-based system may be counter-productive in the short term. We acknowledge, however, that trait-based regulation may be a valid long-term aim in order to develop a more scientifically robust, overarching regime once current regulatory barriers within 2001/18/EC have been addressed. Monitoring and surveillance of persisting GMOs

.Persistence is not currently accounted for within the directive 2001/18/EC. The Institute for Science, Innovation and Society at the University of Oxford highlighted that ‘future-proofing’ would be needed in light of the development of self-sustaining, persistent gene-drive techniques: “These ‘second generation’ varieties will present a radical challenge to existing regulatory frameworks. For one, they will likely require forms of pre-release testing and post-release monitoring yet to be developed.”

.Mechanisms will be required in order to allow for effective post-release monitoring and tracking of new genetic material promoted via gene drives, and designed to persist in the environment, particularly as these may not be included within 2001/18/EC. This could include means to implement both ecological monitoring and GM screening. The Institute for Science, Innovation and Society continued: “We need better tools for the monitoring of GM insects in the environment, and the development of these tools needs to be addressed in a public and straightforward manner by the relevant scientific and regulatory institutions.” We are persuaded by these arguments.

The ecological impact of GMOs designed to persist in the environment presents a new regulatory challenge. In light of the advances in gene-drive research, we conclude that underpinning research is required in order to allow effective monitoring and tracking of this new generation of genetic modifications. The regulatory framework should take persistence into account and stipulate appropriate monitoring requirements. Consideration of benefits and evaluation alongside alternatives

We heard a number of times that taking into account the benefits of a technology could be a desirable addition to the current regulatory process. ACRE has given thought to how this could work within the existing framework. Professor Rosemary Hails explained to us that: “For example, in the whole risk assessment process, the very last question is to characterise the overall risk of a GM organism. Additional information could be provided on context under that question and that context could include benefits also. The reason why that does not happen routinely is the questions leading up to that final question do not put in the building blocks for benefits in the same way as they do for risks.”

Although any rational approach to deciding whether or not to pursue a given technology would include an assessment of its net benefits, the key element must first be sound scientific risk assessment. Professor John Mumford stated: “the risk assessment stage should be independent of values such as benefits. Those may enter at a later stage at the risk management stage, where a decision is made, but not at the assessment stage. Assessment should be objective and management should focus on performance and benefits.”

We heard different views on how benefits might be considered. Benefits and risk are often considered as opposites. However, Sir Roland Jackson, Executive Chair, Sciencewise, questioned this linkage and stressed that benefit is not the opposite of risk. He urged that benefits and dis-benefits be considered alongside each other. Risks and dis-benefits must not be conflated. He provided us with the following clarification: “Questions of benefits encompass a much wider range of issues than the question of science-defined risk. If you are to have a system that looks at benefits as well as risk, you have to look at wider dis-benefits—things like impacts on employment, ways of farming or landscapes, which are not dealt with in a risk assessment.”

Benefits must be considered at an appropriate stage of the regulatory process and not confused with scientific risk assessment. We consider that benefits and dis-benefits should be considered after the process of scientific risk assessment has taken place, at the risk management stage.

As well as confusion surrounding benefits and dis-benefits, more clarity is needed in considering hazard, exposure, risk, and vulnerability. In the Government Chief Scientific Advisor’s 2014 annual report Innovation: managing risk, not avoiding it, Sir Mark Walport argued that it is vital that these terms are understood.

Hazard is frequently equated or confused with risk, and this leads to poor debate, confused communication and flawed decision-making.

.Professor Austin Burt highlighted the potential perversity in not including consideration of the benefits of a GM insect strategy. He stated: “I would not go to a Government in sub-Saharan Africa with this idea of a genetically modified mosquito and not talk about malaria. That does not make sense.”

Professor Luke Alphey reiterated this view: “If you are not talking about the benefits and the reasons why you are doing it, how will you persuade anybody it is worth doing? At that level it does not make any sense.”

The Government do not think that considering benefits should be pursued, despite appreciating the logic behind these arguments. George Eustice MP suggested that such a move would be unlikely to make a significant change in ameliorating the current major problems at the EU level: “My argument would be if the problem is a political barrier and an overly cautious political culture, to say that we are just going to balance the risk against benefits does not do much to reassure that problem.”

Dr Ladislav Miko, Deputy Director-General in the DG for Health and Food Safety at the European Commission, corroborated this perspective: “In my view, all the experience we have shows that the position of member states which are not supporting the GMs will not be dramatically changed by any socio-economic analysis.”

Benefits were not the only additional consideration that we were told ought to be incorporated into the regulatory regime. As previously highlighted, in the current regime GMOs are effectively considered against an idealised, risk-free alternative. Obviously such an alternative does not exist. Furthermore, for many GM insect technologies, the alternative presents a number of risks and problems. In many cases, this is the imperative behind the development of the GM insect technology in the first place. A clear example is insecticides.

The Institute for Science, Innovation and Society called for evaluation of GM insects alongside alternative approaches to the problem in question. They stated that: “Application of genetic methods of insect control should be evaluated alongside alternative courses of action.” While the existing plausible pathways to harm requirements go some way towards acknowledging this, we perceive it to be vital that, on a case-by-case basis, appropriate comparators are used.

We consider the argument for including the benefits of a technology within the regulatory process to be entirely valid. Furthermore, we do not agree with the stance of the Government and the European Commission that there would be little to gain in modifying the current framework to include consideration of benefits. We recommend that consideration of benefits and dis-benefits be incorporated into the regulatory regime once the scientific risk assessment has taken place, during the risk management stage.

Furthermore it is inappropriate that new GMO technologies are considered in relation to an unrealistic, risk-free alternative. We recommend that the regulatory process should acknowledge control methods currently in use, such as insecticides, which a new technology may replace.

It is clear to us that the regulatory regime is failing as it is currently applied to GM crops. Furthermore, we envisage that these failings would likely affect GM insect applications. Views on how the regime could be improved are numerous. Action, as we recommended earlier in this chapter, needs to be taken to try and improve the current system, but this is only sufficient as a first step.

We are concerned that a situation has arisen whereby applications are not received due to concerns over the regulatory framework, yet the regulatory framework cannot be tested nor improved until such an application materialises. There are concerns that GM insect applications would likely be subjected to the considerable delays experienced by crop applications. The Minister, George Eustice MP, described such applications to us as being “stuck in limboland.”

Action needs to be taken to try and breathe new life into this policy area and provide some momentum and a focus for activity. It is with this in mind that we think the Government should initiate an insect trial akin to the Farm Scale Evaluations of new GM crop technologies. In our view, this would represent a positive means of trying to break the regulatory deadlock.

Privacy Sales

'Shopping for privacy: Purchase details leaked to PayPal' by Sören Preibusch, Thomas Peetz, Gunes Acar and Bettina Berendt in Electronic Commerce Research and Applications comments

We present a new form of online tracking: explicit, yet unnecessary leakage of personal information and detailed shopping habits from online merchants to payment providers. In contrast to the widely debated tracking of Web browsing, online shops make it impossible for their customers to avoid this dissemination of their data. We record and analyse leakage patterns for the 881 most popular US Web shops sampled from actual Web users’ online purchase sessions.

More than half of the sites we analysed shared product names and details with PayPal, allowing the payment provider to build up fine-grained and comprehensive consumption profiles about its clients across the sites they buy from, subscribe to, or donate to. In addition, PayPal forwards customers’ shopping details to Omniture, a third-party data aggregator with even larger tracking reach than PayPal itself. Leakage to PayPal is commonplace across product categories and includes details of medication or sex toys. We provide recommendations for merchants.

The authors conclude -

We presented a new species in the zoo of online tracking systems: explicit leakage of personal information and detailed shopping habits from online merchants to payment providers. In contrast to the widely debated tracking of Web browsing, online shops make it impossible for their customers to avoid this proliferation of their data.

By mediating online payments between merchants and buyers, payment providers are in a position to access sensitive payment details that can be used to build a detailed profile of shopping habits. Being the most popular payment provider, PayPal learns how much money its 152 million customers are spending and where. These customers are identified by name, email and postal address and through their bank details. We have demonstrated that merchant Websites are unnecessarily forwarding product details to PayPal that give a detailed view on consumers’ purchases.

According to the 881 sites studied in our analysis, 52% of the most popular US Web shops shared product names, item numbers and descriptions with PayPal. Besides the negative privacy impact, consumers whose data are proliferating could suffer from less favourable payment terms (e.g., unavailable payment methods of higher interest rates on consumer loans based on their purchase patterns). On the other hand, the remaining 388 sites did not share any purchase details except the amount to be paid, confirming that sharing sensitive details is not necessary for electronic retailers.

Further, we reported on the PayPal’s use of the tracking service Omniture, which amplifies the privacy concerns by exposing transaction details to a widely deployed third-party tracker. A third-party tracker that has access to general Web tracking information, as well as to the details of successfully completed transactions, is in a particularly privileged situation to monitor consumption choices at large.

Web shops that use the technically more advanced token-based integration are often more privacy-friendly. Also, less popular sites are significantly more often among those that leak more personal information. There are no systematic differences across product categories, meaning that all kinds of shoppers are exposed.

To the extent that PayPal, as an example of payment providers in general, collects personal information at scale, it becomes a constituent part of the online shopping experience: neither researchers nor enforcement authorities can reduce its role to a passive intermediary when assessing the privacy impact of e-commerce transactions.

By exploring the alternative privacy preserving practices that can be followed by Web shops, we distilled the following suggestions for merchants:

(1) apply data minimization principle—do not leak information that is not required for processing the transaction;

(2) inform customers about the data sharing in your privacy policy;

(3) offer alternative, privacy-friendly payment methods, such as direct debit or pre-payment;

(4) use a payment gateway to prevent leakage of product URL via referrer header.

Future research through qualitative interviews with decision-makers and engineers at merchants should look at the drivers and motives behind PayPal integration choices and their privacy consequences. On the technical side, expanding the scope to mobile and in-app payments promises valuable for these growing, yet opaque transactions. Better privacy practices for handling online payments are not only desirable for end users, but also for the merchants and payment providers whose businesses depend on the users’ trust.

At times when personal information is said to be new currency on the Web, it seems unfair that consumers are charged twice during checkout.