In Response: Resolving the perception of bias in a discipline founded on objectivity—A perspective from industry

Science should be objective and should be evaluated based on its merit rather than its funding source. However, a perception exists among parts of society that research sponsored by industry is inherently biased, and perhaps more insidious is the notion that academics who collaborate with industry partners are therefore also biased by association. This misconception is not only unproductive but actually counterproductive as it devalues research based on funding source, detracts from the collaborative SETAC tripartite paradigm (business, government, and academia), and corrodes the educational fabric from which all scientists are sewn. Why is it that society assigns bias solely by affiliation post hoc? Most students enter college with an ambiguous, often fanciful, notion of a career path, which is dynamic and subject to change during the formative years of undergraduate studies but which does serve to inform field of discipline or interest. Moreover, at the conclusion of a graduate degree or postdoctoral appointment, a career path can still be frequently indeterminate, absent definitive commitment of figurative orientation toward any particular angle of the tripartite paradigm. The reality is that occupation is rarely predetermined but rather subject to opportunity and the nuances of the job market and availability. Moreover, mentors can have a disproportionate influence, either reinforcing bias by affiliation or encouraging students to explore all options when seeking the most appealing opportunity for employment. However, it is at this crucial juncture that society often ascribes bias by affiliation. This is a peculiar and seemingly illogical behavior given that employees in government, industry, and academia are all sourced from the same educational system, from the same academic institutions, and often from the same laboratories, mentors, and advisers, which instill commensurate scientific training, education, experience, integrity, morals, and ethics. Consequently, an insinuation of affiliation bias categorically ignores educational equality and job opportunity/availability and is therefore completely irrational. Ultimately, society would be better served by tripartite cooperation rather than tripartite segregation; and we, as members of the scientific community, and more importantly as members of society, have the capacity to effect this change. Why does the public mistrust “industry-sponsored” research? Historical examples of naiveté and negligence fostering skepticism about the pesticide industry certainly exist. Regarding the latter, among the most egregious and notorious examples is Agent Orange 1, a tragic illustration of gross misconduct that can be neither tolerated nor defended. Regarding the former, perhaps the most prominent example is DDT. The initial discovery of DDT was hailed as a public health miracle in terms of controlling the vector-borne spread of malaria, though there were obvious unintended environmental consequences that were exposed by the seminal work of Rachel Carson 2. However, it is important to keep in mind that this revelation led to the establishment of the US Environmental Protection Agency (USEPA) and effective regulation of the pesticide industry. Still, it is generally not understood that the pesticide industry is in fact intensively and stringently regulated; in the United States, this is done under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 3. In addition, the environmental and health scientists who work for industry have a moral obligation and ethical responsibility to inform their management of the risk of harm, a very important function supporting the development and use of the products a company produces. Much of the data generated by industry are submitted as confidential business information status under FIFRA statutes that protect its confidentiality (FIFRA Sections 10 and 3[c][1][F]; section 10 is trade secrets, and section 3[c][1][F] is data compensation), resulting in public suspicion and frustration, although the US Congress recognized this as a problem and implemented checks and balances that govern the standards by which scientific data are generated by industry. However, as described by Hon and Grunig 4, distrust is not the absence of trust, nor is trust the absence of distrust, though distrust is more salient than trust since negative information is considered to have a stronger effect on public perceptions than positive information 5. In addition, distrust has 2 dimensions: lack of credibility and malevolence 4, 5. The former is resultant primarily from lack of transparency (i.e., data confidentiality) and lack of public understanding of the regulatory process, and the latter derives largely from the for-profit status of corporations. Although confidential business information and corporate profit are challenging perceptual hurdles to overcome, greater transparency, education, and credibility can be achieved through tripartite collaboration. Furthermore, increasing the understanding of the process whereby industry-sponsored research is conducted and used by government agencies will aid in establishing and promoting trust. Industry is required to submit studies on the environmental fate and effects of their products under the good laboratory practice regulations 6. These regulations, which have been in place for more than 25 yr, cover studies submitted to regulatory agencies worldwide on many types of substances (pesticides, drugs, industrial chemicals, etc.). Good laboratory practice encompasses many of the basic elements of conducting a sound scientific investigation, including having appropriately trained and qualified personnel, maintenance and calibration of equipment, handling of test and reference substances, written standard operating procedures, inspection by an independent quality assurance unit, detailed record-keeping to allow reconstruction of the study, and archiving of all data. Good laboratory practice compliance thereby promotes reliability. Nonetheless, good laboratory practice studies often do not see daylight in the peer-reviewed literature, and there are valid business reasons for this, including the preservation of compensability for the studies. (When a chemical's patent protection expires, other companies may seek to develop products based on the intellectual property developed to support a particular technology. The company that owns the intellectual property is entitled to data compensation when another company uses this information for their product.) Companies may still be willing to publish results, but few high-impact journals are interested in the results of routine standard toxicity tests conducted in support of pesticide registration. However, another set of “checks and balances” is provided when the government regulatory agency conducts an independent review of the good laboratory practice study. These study reviews and summaries are usually available to the public under the Freedom of Information Act in the United States. Under FIFRA, for example, the USEPA issues “data-evaluation records,” which provide the agency's review, analysis, and interpretation of the good laboratory practice study. The USEPA also routinely conducts inspections of performing laboratories to ensure good laboratory practice compliance. Part of the “checks and balances” inherent in regulation not only in the United States but also in other regulatory jurisdictions, such as Canada and Europe, is the requirement of industry to report the adverse effects of their products. In the United States, these important laws are a part of FIFRA and the Toxic Substances Control Act legislation under sections 6(a)(2) and 8(e), respectively. These laws require a company to report any information that may impact a safety assessment and, in the United States, give very specific time frames by which the information must be reported. These laws are taken very seriously, as there are fines, civil penalties, and possible jail time for failure to comply; companies spend considerable resources in compliance with these laws. As members of the greater scientific community, scientists in the business sector have important contributions to make, and these should not be perceptually devalued relative to other tripartite entities because of preconceived notions of bias. Clearly, misunderstanding exists regarding the roles and responsibilities of scientists in the business sector; however, increased education, collaboration, transparency, and public outreach can be instrumental in promoting better understanding of the roles and responsibilities of scientists from all sectors. Already, SETAC has embraced the ideology that we are stronger when working together; and it will take collective, concerted, and cooperative tripartite efforts to address the many daunting environmental and societal challenges looming on the horizon. As stated by Helen Keller, “alone we can do so little; together we can do so much.” Richard Brain Syngenta Crop Protection Greensboro, NC, USA Jane Staveley Exponent Cary, NC, USA Lisa Ortego Bayer CropScience Research Triangle Park, NC, USA