Academic literature on the topic 'VA Medical Center (Albuquerque, N.M.)'

Abstract Introduction Positive airway pressure (PAP) compliance for the treatment of sleep apnea at the Albuquerque Veterans Affairs (VA) Sleep Medicine clinic has been observed to be lower in new setup patients after the onset of the COVID-19 pandemic. The reasons for decreased PAP compliance during the COVID-19 pandemic are unclear. The primary outcome will be to identify if there is a common reason that patients at the Albuquerque VA were less compliant with PAP after the onset of the COVID-19 pandemic. Methods Compliance data for 4/1/2020 through 9/30/2020 was compared to compliance data for 4/1/2019 through 9/30/2019. Compliance after PAP machine setup was confirmed to be lower during the 2020 time period. Noncompliant patients will be selected by setup type, new versus machine replacement, and surveyed for reasons for noncompliance. The survey will be conducted at the Albuquerque VA Sleep Center and will include questions regarding beliefs, barriers, and challenges with the use of PAP therapy during the coronavirus pandemic. The definition for initial PAP compliance will be the use of PAP therapy for greater than or equal to four hours per night on at least 70% of nights. Results For the 6-month time period of 4/1/2019 through 9/30/2019, there were 758 PAP setups at the Albuquerque VA. The 30-day compliance for the 758 setups was found to be 61.4%. Comparatively, for the six-month period of 4/1/2020 through 9/30/2020, there were 462 setups with a 30-day compliance result of 49.7%. A survey consisting of questions designed to elicit barriers to use as well as beliefs regarding PAP and COVID-19 will be administered to 20% (n = 46) of the non-compliant patients who were set up with a PAP machine during the 2020 study period. Conclusion PAP compliance after machine setup was lower at the Albuquerque VA sleep center in 2020 versus 2019 (49.7% versus 61.4%). The reasons for the lower observed compliance are attributed to the effects of the coronavirus pandemic. A random sampling of the non-compliant patients during the 2020 time period will be performed and the results will be presented once available. Support (if any) None

Abstract Background: Hepatitis C Virus (HCV) is a major public health problem, with an increased prevalence in Veterans. HCV has been associated with B cell Lymphoproliferative disorders and Type II and III Cryoglobulinemias.Prior studies also found that patients with HCV are more likely to develop cytopenias compared normal. Little is known about other possible hematologic manifestations of HCV.We present a series of 54 Veterans seen in a hematology oncology clinic with HCV and their hematologic and bone marrow findings Methods: In an IRB-approved protocol, we reviewed the records of V with HCV who underwent bone marrow biopsy from January 1993 to July 2015. V with hematological malignancies, coinfection with human immunodeficiency virus (HIV), hepatitis A or B, were excluded. Demographics, Vietnam era status, clinical and pathological data, indications for bone marrow biopsies, and results were abstracted. Statistical analysis was performed using SAS 9.4. Results: Of the 54 V, 30 Caucasians, 22 African Americans and 2 Hispanics met the eligibility criteria. 37 served in the Vietnam era. The median (M) age was 59 years (range 39-90). M for WBC 6.9 x109/L (2.9-36.3), hemoglobin 14.3 gm/dL (6.9-19), MCV 93.1 fL (68.8-110..6), platelets 172 x109/L (39-493) , total bilirubin 0.75 mg/dl (0.1-5.3), alkaline phosphatase 96.5 U/L (56-341), albumin 3.9 g/dl (1.6-4.9), lactate dehydrogenase 191 IU/L (91-867), AST U/L (19-426), ALT 56.5.U/L (4-480), INR 1.09 (0.84-2.04). 12 V had splenomegaly by imaging. 10 V at the time of bone marrow biopsy had cirrhosis. The most common indication for bone marrow biopsy was cytopenia (n=38) in at least one of the lineages. The remaining (n=16) were for paraproteinemia, lytic lesion, leukocytosis or lymphocytosis. 48 V had abnormal bone marrow biopsy findings (summarized in Table 1) and 6 V had normal biopsy findings.Table 1.Bone Marrow Findings (n=48)Dysplasia15Hyperplasia14Benign Lymphoid Aggregate4Plasma Cells3Leukemia, Plasma cell dyscrasia4Combination of hyperplasia, lymphoid aggregates or plasma cells8 Conclusions: Veterans with HCV develop cytopenias and hematological malignancies. While Cytopenias can result from splenomegaly, autoimmune mechanism, and medications, some of the cytopenias are unexplained Bone marrow changes from chronic HCV infection may be a contributing factor. Understanding these bone marrow changes from HCV may help in determining the etiology and further management of hematological problems related to HCV Disclosures No relevant conflicts of interest to declare.

Abstract Introduction Neuroprotection, early diagnosis, and behavioral intervention are national priorities for dementia research. Sleep duration is emerging as an important potential remediable risk factor. In this study, we examined the total sleep time derived from overnight polysomnography (PSG) studies in veterans with a current dementia diagnosis at the time of PSG study (dementia), future diagnosis of dementia following the PSG study (incipient dementia), and no diagnosis of dementia at any time point (no dementia) over a 19-year period. Methods We identified 69,847 PSG sleep studies using CPT code 95810 and all-cause dementia diagnosis using ICD 9/10 codes (e.g., F03.90) from 2000-19 in the US Department of Veteran Affairs (VA) national database. To be included patients must have ≥ 1 VA visits in 12 months leading up to PSG. Dementia diagnosis must be documented on two separate visits between 12 months prior to 6 months following PSG for current dementia group and anytime after the PSG for incipient dementia. We used natural language processing to extract TST values from the patient free-text notes. Analysis of variance was used to compare PSG TST of the three groups. Results Patients had a mean age of 55.4±13.8 at the time of PSG study, 91.5% were male, and 64% were Caucasian. TST of dementia patients (N=1,031) was m=257±110m (d=0.33, p<.05), incipient dementia (N=1,875) was m=253±116m (d=0.35, p<.05) versus no dementia (61,871) m=292±104mins. Conclusion Patients with a diagnosis of dementia at the time of PSG study and patients that went on to receive a diagnosis following their PSG study had a significantly lower total sleep time compared to patients that have never received a dementia diagnosis. This is an important study that compares sleep duration during overnight PSG studies and dementia diagnosis across 19 years in the largest integrated healthcare system in the US. Support This material is based upon work supported in part by the Department of Veteran Affairs, Veterans Health Administration, Office of Research and Development, and the Center for Innovations in Quality, Effectiveness and Safety (CIN 13-413). Dr. Nowakowski is also supported by a National Institutes of Health (NIH) Grant (R01NR018342).

Abstract Introduction For persons with moderate-to-severe traumatic brain injury (TBI), chronic cognitive impairment contributes to long term disability. Health comorbidities may contribute to the neurologic burden in TBI. Indeed, obstructive sleep apnea (OSA) is associated with neuropathological and cognitive changes. The objective of this study was to examine the relationship between OSA and cognition after TBI. Methods Participants were prior inpatient rehabilitation patients drawn from the Tampa VA TBI Model Systems longitudinal study. Post-discharge interviews occurred 2 to 6 years post-TBI. Participants reported whether they were diagnosed with OSA and completed the Brief Test of Adult Cognition by Telephone (BTACT) which measures recall, working memory, processing speed, fluency, and reasoning. Participants with polysomnography (PSG) were separately analyzed to examine the impact of sleep apnea severity (i.e., Apnea-Hypopnea Index [AHI]) on cognition. Results Participants (N=104) were mostly male (95.2%), age M=37.7 (SD=12.5), Education M=13.6 years (SD=2.1), and 45.2% were diagnosed with OSA. Participants with and without OSA did not differ by age, education, gender, or time since injury at time of BTACT (ps > .05). ANCOVAs were conducted examining OSA diagnosis on BTACT subscale scores, covarying TBI severity level, but results did not reach statistical significance (ps > .05). A subset of participants with OSA had PSG (n=27), AHI score quartiles = 6.7/10.4/21.6. Higher AHI was associated with poorer reasoning (Spearman ρ = -0.45, p = .019). Nonsignificant results were found for word recall (Spearman ρ = -0.35, p = .074) and processing speed (Spearman ρ = -0.36, p = .069). Conclusion Severity of sleep apnea may influence aspects of cognition among persons with TBI, although these results are preliminary and need replication with a larger and more representative sample. Support This work was supported by the Veterans Health Administration Central Office VA TBI Model Systems Program of Research and subcontract from General Dynamics Information Technology [W91YTZ-13-C-0015, HT0014-19-C-0004] from the Defense and Veterans Brain Injury Center (DVBIC); and from the United States Department of Veterans Affairs [W81XWH-13-2-0095]; and from the United States Department of Defense Congressionally Directed Medical Research Programs; and from the Patient Centered Outcomes Research Institute (PCORI) [CER-1511-33005].

Purpose: Veterans with post-traumatic stress disorder (PTSD) lose less weight in the Veterans Affairs (VA) weight management program (MOVE!), so we developed MOVE!+UP. Design: Single-arm pre–post pilot to iteratively develop MOVE!+UP (2015-2018). Setting: Veterans Affairs Medical Center. Participants: Overweight Veterans with PTSD (5 cohorts of n = 5-11 [N = 44]; n = 39 received ≥1 MOVE+UP session, with cohorts 1-4 [n = 31] = “Development” and cohort 5 [n = 8] = “Final” MOVE!+UP). Intervention: MOVE!+UP weight management for Veterans with PTSD modified after each cohort. Final MOVE!+UP was coled by a licensed clinical psychologist and Veteran peer counselor in 16 two-hour in-person group sessions and 2 individual dietician visits. Sessions included general weight loss support (eg, behavioral monitoring with facilitator feedback, weekly weighing), cognitive-behavioral skills to address PTSD-specific barriers, and a 30-minute walk to a nearby park. Measures: To inform post-cohort modifications, we assessed weight, PTSD, and treatment targets (eg, physical activity, diet), and conducted qualitative interviews. Analysis: Baseline to 16-week paired t tests and template analysis. Results: Development cohorts suggested improvements (eg, additional sessions and weight loss information, professional involvement) and did not lose weight (mean [ M] = 1.8 lbs (standard deviation [SD] = 8.2); P = .29. Conversely, the final cohort reported high satisfaction and showed meaningful weight ( M = −14 pounds [SD = 3.7] and 71% lost ≥5% baseline weight) and PTSD ( M = −17.9 [SD = 12.2]) improvements, P < .05. Conclusions: The comprehensive, 16-week, in-person, cofacilitated Final MOVE!+UP was acceptable and may improve the health of people with PTSD. Iterative development likely produced a patient-centered intervention, needing further testing.

Abstract Introduction Obstructive sleep apnea (OSA) is a condition that is prevalent, pernicious, and linked to the development and exacerbation of several disease processes. Positive airway pressure (PAP) is a highly efficacious intervention; however, initiation and adherence rates are poor. This represents a critical gap in care and a missed opportunity to reduce morbidity and mortality associated with OSA. The present study piloted a single session of cognitive behavioral therapy for treatment seeking (CBT-TS) among veterans diagnosed with obstructive sleep apnea and newly prescribed PAP. Methods Participants were asked to complete assessments at baseline and at two- and four-weeks post-intervention. A sample of 40 Veterans were enrolled in the study and completed a baseline interview, 27 completed CBT-TS. A matched comparison group of 64 veterans who did not receive the intervention was constructed using electronic medical record and PAP adherence data. Mann Whitney U and Chi Square tests were used to examine group differences in initiation and adherence. Results Participants who completed the CBT-TS session were more likely to initiate PAP (at least 3 consecutive nights of use) as compared to those receiving treatment as usual (TAU) [(CBT-TS; 96.3%; 26/27) versus (TAU; 64.1%; 41/64); X2(1, N = 91) = 10.16, p = .001]. Participants in the CBT-TS group also used their PAP devices for a greater number of nights over the first month than the comparison group [(CBT-TS; M = 21.7 (SD = 8.9), Mdn = 26.0) versus (TAU; M = 14.4 (SD = 12.6), Mdn = 15.5); U = 555.0, p = .007] and were more likely to use the device in an adherent manner (i.e., ≥4 hours use in an evening); [(CBT-TS; M = 15.1 (SD = 11.2); Mdn = 15.0) versus (TAU; M = 10.3 (SD = 11.2), Mdn = 6.5); U =630.0, p = .038]. Conclusion These preliminary data suggest that CBT-TS may have utility in increasing initiation of PAP and subsequent treatment adherence among Veterans diagnosed with OSA and newly prescribed PAP. Support (if any) This work was supported by the VA Center of Excellence for Suicide Prevention in the Finger Lakes Healthcare System.

The United States (US) has been at war for almost two decades, resulting in a high prevalence of injuries and illnesses in service members and veterans. Family members and friends are frequently becoming the caregivers of service members and veterans who require long-term assistance for their medical conditions. There is a significant body of research regarding the physical, emotional, and social toll of caregiving and the associated adverse health-related outcomes. Despite strong evidence of the emotional toll and associated mental health conditions in family caregivers, the literature regarding suicidal ideation among family caregivers is scarce and even less is known about suicidal ideation in military caregivers. This study sought to identify clusters of characteristics and health factors (phenotypes) associated with suicidal ideation in a sample of military caregivers using a cross-sectional, web-based survey. Measures included the context of caregiving, physical, emotional, social health, and health history of caregivers. Military caregivers in this sample (n = 458) were mostly young adults (M = 39.8, SD = 9.9), caring for complex medical conditions for five or more years. They reported high symptomology on measures of pain, depression, and stress. Many (39%) experienced interruptions in their education and 23.6% reported suicidal ideation since becoming a caregiver. General latent variable analyses revealed three distinct classes or phenotypes (low, medium, high) associated with suicidality. Individuals in the high suicidality phenotype were significantly more likely to have interrupted their education due to caregiving and live closer (within 25 miles) to a VA medical center. This study indicates that interruption of life events, loss of self, and caring for a veteran with mental health conditions/suicidality are significant predictors of suicidality in military caregivers. Future research should examine caregiver life experiences in more detail to determine the feasibility of developing effective interventions to mitigate suicide-related risk for military caregivers.

Breast arterial calcification (BAC) is an emerging marker of atherosclerotic cardiovascular disease (CVD) risk. However, most prior studies relied on traditional film mammography and on the dichotomy of presence/absence of BAC. Furthermore, race/ethnic differences in BAC are not well documented. The M ult i eth n ic Study of Br e ast A r terial Calcification and Cardio va scular Risk ( MINERVA ) study recruited 5,040 postmenopausal women after they underwent routine digital screening mammography at one of nine Northern California Kaiser Permanente Centers between 3/21/2013 and 9/1/2015. Study participants were free of CVD at baseline, and underwent an extensive clinic visit for ascertainment of CVD risk factors. Presence and gradation of BAC (calcium mass in mg) on raw images by dedicated software were ascertained by a novel densitometry method at the BAC Reading Center at UC Irvine. Data on BAC and demographics are presented here on the first 2,597 mammograms read. The mean age of the cohort was 66.5 ± 4.6 [range, 60-79 years old] and the ethnic breakdown was 67% white, 9% African-American, 10% Asian/Pacific Islander, 8% Latina and 6% mixed/other race. The overall prevalence of any BAC (calcium mass>0) was 30% (773/2,597) and increased with age: 26% in 60-69, 38% in 70-74 and 54% in 75-79 year old women. By race, BAC presence was higher in Latina (37%, 75/203), followed by African-American (30%, 66/222), white (29%, 514/1750), mixed/other (28%, 48/159), and Asian women (28%, 73/263). The age- and ethnic-specific gradation BAC data are summarized in the Table. Variation of BAC gradation was significant across age (Chi-square=142; p=0.0001) and nearly significant across race/ethnic groups (Chi-square=26; p=0.06). Overall, only 3% of women had a calcium mass between 11 and 25, with 3% over 25 mg. These percentages were higher among women over age 75 and in Latinas and African-Americans. These results document, for the first time, significant differences in BAC presence and gradation as a function of age and race/ethnicity.

The objective of this article is to explore how suitable Team-Based Learning (TBL) is for students with social and communication disabilities, such as those on the autism spectrum or with social anxiety. TBL is a structured form of Active Collaborative Learning, combining a flipped classroom approach with students working in permanent teams to apply concepts, models and theories into practice. The design of the study was based on an idiographic case study approach at Anglia Ruskin University, UK, treating each student as an individual rather than a representative sample. Towards the end of the academic year 2017/18, an electronic questionnaire was sent out to all students who had taken TBL modules at ARU during the preceding academic year, asking about various aspects of TBL experience. The questionnaire was repeated towards the end of the first semester of 2018/19. The questionnaire was analysed with a focus on questions relating to inclusivity, and the responses related to students who had declared a disability. The questionnaire was followed by semi-structured interviews with students with disabilities who had experienced TBL. We focused primarily on disabilities broadly related to communication, notably with dyslexia, dysgraphia, social phobia and autism that may impair students’ abilities to work in teams. Interviews were audio recorded and then transcribed. Transcriptions were thematically analysed by the research team using NVivo. The results of the study provide anonymized case studies for each of the students who took part in an interview, explaining their disability or condition, their coping strategies for studying in HE, and their experiences, both positive and negative, of the TBL modules they had taken. References Active Collaborative Learning. (2019). Scaling Up Active Collaborative Learning for Student Success. Project website. https://aclproject.org.uk. ARU. (2017). Equality, Diversity and Inclusion at our University. Annual Report. Anglia Ruskin University.https://web.anglia.ac.uk/anet/student_services/public/AngliaRuskinReport_2017_AW_ACCESSIBLE.pdf. ARU. (2018). Student Snapshots. Anglia Ruskin University. https://aru.ac.uk/about-us/equality-diversity-and-inclusion/equality-diversity-and-inclusion-for-students/aru-student-snapshots. ARU. (2020). Disability Support. Anglia Ruskin University. https://aru.ac.uk/student-life/support-and-facilities/study-skills/disability-support. ARU. (2020b). Inclusive Practices. Anglia Ruskin University. https://aru.ac.uk/about-us/equality-diversity-and-inclusion/equality-diversity-and-inclusion-for-students/inclusive-practices. Berkson, R., & Richter, U.M. (2019). Can Active Collaborative Learning Improve Equality? The European Conference on Education 2019 Official Conference Proceedings. https://papers.iafor.org/submission51859/. 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Haidet, P., Kubitz, K., & McCormack, W. T. (2014). Analysis of the team-based learning literature: TBL comes of age. Journal on Excellence in College Teaching, 25(3-4): 303-333. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4643940/. Hefce. (2018). Differences in student outcomes. The effect of student characteristics. Data Analysis report March 2018/05. https://dera.ioe.ac.uk/31412/1/HEFCE2017_05%20.pdf HM Government. (2017). Industrial Strategy. Building a Britain fit for the future. UK Government White Paper. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/664563/industrial-strategy-white-paper-web-ready-version.pdf. Kent, S., Wanzek, J., Swanson, E.A., & Vaughn, S. (2015). Team-Based Learning for Students with High-Incidence Disabilities in High School Social Studies Classrooms. Learning Disabilities Research & Practice, 30(1): 3-14. https://onlinelibrary.wiley.com/doi/abs/10.1111/ldrp.12048. 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Centre for Academic Development and Quality, Nottingham Trent University. https://www.ntu.ac.uk/__data/assets/pdf_file/0033/906927/FINAL-SCALE-UP-Handbook-2019-20.pdf. McNeil, J., Borg, M., Kerrigan, M., Waller, S., Richter, U., Berkson, R., Tweddell, S., & McCarter, R. (2019b). Addressing barriers to student success. Scaling up Active Collaborative Learning for Student Success. Final Report, 28 March 2019, Updated 28 October 2019. https://aclproject.org.uk/wp-content/uploads/2019/07/NTU-ABSS-Final-Report-revised-Oct-2019.pdf. OECD. (2019). OECD Future of Education and Skills 2030. OECD Learning Compass 2030. A Series of Concept Notes. OECD. http://www.oecd.org/education/2030-project/contact/OECD_Learning_Compass_2030_Concept_Note_Series.pdf. Office for Students. (2019a). Addressing Barriers to Student Success programme. https://www.officeforstudents.org.uk/advice-and-guidance/promoting-equal-opportunities/addressing-barriers-to-student-success-programme/ Office for Students. (2019b). Beyond the bare minimum: Are universities and colleges doing enough for disabled students? OfS Insight Brief 4. https://www.officeforstudents.org.uk/publications/beyond-the-bare-minimum-are-universities-and-colleges-doing-enough-for-disabled-students/#participation. Roulston, K., & Shelton, St. A. (2015). Reconceptualizing Bias in Teaching Qualitative Research Methods. Qualitative Inquiry, (21)4: 332-342. https://journals.sagepub.com/doi/10.1177/1077800414563803. Sangwan, P., & Sangwan, S. (2011). Inclusive Education: A Developmental Approach in Special Education. Journal of Indian Education, 36(4): 18-32. http://www.ncert.nic.in/publication/journals/pdf_files/iea/JIE_FEB2011.pdf#page=20 Sibley, J., & Ostafichuk, P. (2014). Getting Started with Team-Based Learning. Sterling, VA, USA: Stylus. Sisk, R. J. (2011). Team-based learning: systematic research review. Journal of Nursing Education, 50(12): 665–669. https://pubmed.ncbi.nlm.nih.gov/22007709/. Vaccaro, A., Daly-Cano, M., & Newman, B. M. (2015). A sense of belonging among college students with disabilities: An emergent theoretical model. Journal of College Student Development, 56(7): 670-686. https://muse.jhu.edu/article/597267 Vaughn, S., Danielson, L., Zumeta, R., & Holdheide, L. (2015). Deeper Learning for Students with Disabilities. Students at the Center. Deeper Learning Research Series. Boston, MA: Jobs for the Future. https://files.eric.ed.gov/fulltext/ED560790.pdf. Wanzek, J., Vaughn, S., Kent, S.C., Swanson, E.A., Roberts, G., Haynes, M., & Solis, M. (2014). The Effects of Team-Based Learning on Social Studies Knowledge Acquisition in High School. Journal of Research on Educational Effectiveness. 7(2): 183-204. https://www.tandfonline.com/doi/abs/10.1080/19345747.2013.836765. Williams, M., Pollard, E., Helena Takala, H., & Houghton, A-M. (2019). Review of Support for Disabled Students in Higher Education in England. 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A same-but-different dichotomy has recently been encapsulated within the US Food and Drug Administration’s ill-defined concept of “substantial equivalence” (USFDA, FDA). By invoking this concept the genetically modified organism (GMO) industry has escaped the rigors of safety testing that might otherwise apply. The curious concept of “substantial equivalence” grants a presumption of safety to GMO food. This presumption has yet to be earned, and has been used to constrain labelling of both GMO and non-GMO food. It is an idea that well serves corporatism. It enables the claim of difference to secure patent protection, while upholding the contrary claim of sameness to avoid labelling and safety scrutiny. It offers the best of both worlds for corporate food entrepreneurs, and delivers the worst of both worlds to consumers. The term “substantial equivalence” has established its currency within the GMO discourse. As the opportunities for patenting food technologies expand, the GMO recruitment of this concept will likely be a dress rehearsal for the developing debates on the labelling and testing of other techno-foods – including nano-foods and clone-foods. “Substantial Equivalence” “Are the Seven Commandments the same as they used to be, Benjamin?” asks Clover in George Orwell’s “Animal Farm”. By way of response, Benjamin “read out to her what was written on the wall. There was nothing there now except a single Commandment. It ran: ALL ANIMALS ARE EQUAL BUT SOME ANIMALS ARE MORE EQUAL THAN OTHERS”. After this reductionist revelation, further novel and curious events at Manor Farm, “did not seem strange” (Orwell, ch. X). Equality is a concept at the very core of mathematics, but beyond the domain of logic, equality becomes a hotly contested notion – and the domain of food is no exception. A novel food has a regulatory advantage if it can claim to be the same as an established food – a food that has proven its worth over centuries, perhaps even millennia – and thus does not trigger new, perhaps costly and onerous, testing, compliance, and even new and burdensome regulations. On the other hand, such a novel food has an intellectual property (IP) advantage only in terms of its difference. And thus there is an entrenched dissonance for newly technologised foods, between claiming sameness, and claiming difference. The same/different dilemma is erased, so some would have it, by appeal to the curious new dualist doctrine of “substantial equivalence” whereby sameness and difference are claimed simultaneously, thereby creating a win/win for corporatism, and a loss/loss for consumerism. This ground has been pioneered, and to some extent conquered, by the GMO industry. The conquest has ramifications for other cryptic food technologies, that is technologies that are invisible to the consumer and that are not evident to the consumer other than via labelling. Cryptic technologies pertaining to food include GMOs, pesticides, hormone treatments, irradiation and, most recently, manufactured nano-particles introduced into the food production and delivery stream. Genetic modification of plants was reported as early as 1984 by Horsch et al. The case of Diamond v. Chakrabarty resulted in a US Supreme Court decision that upheld the prior decision of the US Court of Customs and Patent Appeal that “the fact that micro-organisms are alive is without legal significance for purposes of the patent law”, and ruled that the “respondent’s micro-organism plainly qualifies as patentable subject matter”. This was a majority decision of nine judges, with four judges dissenting (Burger). It was this Chakrabarty judgement that has seriously opened the Pandora’s box of GMOs because patenting rights makes GMOs an attractive corporate proposition by offering potentially unique monopoly rights over food. The rear guard action against GMOs has most often focussed on health repercussions (Smith, Genetic), food security issues, and also the potential for corporate malfeasance to hide behind a cloak of secrecy citing commercial confidentiality (Smith, Seeds). Others have tilted at the foundational plank on which the economics of the GMO industry sits: “I suggest that the main concern is that we do not want a single molecule of anything we eat to contribute to, or be patented and owned by, a reckless, ruthless chemical organisation” (Grist 22). The GMO industry exhibits bipolar behaviour, invoking the concept of “substantial difference” to claim patent rights by way of “novelty”, and then claiming “substantial equivalence” when dealing with other regulatory authorities including food, drug and pesticide agencies; a case of “having their cake and eating it too” (Engdahl 8). This is a clever slight-of-rhetoric, laying claim to the best of both worlds for corporations, and the worst of both worlds for consumers. Corporations achieve patent protection and no concomitant specific regulatory oversight; while consumers pay the cost of patent monopolization, and are not necessarily apprised, by way of labelling or otherwise, that they are purchasing and eating GMOs, and thereby financing the GMO industry. The lemma of “substantial equivalence” does not bear close scrutiny. It is a fuzzy concept that lacks a tight testable definition. It is exactly this fuzziness that allows lots of wriggle room to keep GMOs out of rigorous testing regimes. Millstone et al. argue that “substantial equivalence is a pseudo-scientific concept because it is a commercial and political judgement masquerading as if it is scientific. It is moreover, inherently anti-scientific because it was created primarily to provide an excuse for not requiring biochemical or toxicological tests. It therefore serves to discourage and inhibit informative scientific research” (526). “Substantial equivalence” grants GMOs the benefit of the doubt regarding safety, and thereby leaves unexamined the ramifications for human consumer health, for farm labourer and food-processor health, for the welfare of farm animals fed a diet of GMO grain, and for the well-being of the ecosystem, both in general and in its particularities. “Substantial equivalence” was introduced into the food discourse by an Organisation for Economic Co-operation and Development (OECD) report: “safety evaluation of foods derived by modern biotechnology: concepts and principles”. It is from this document that the ongoing mantra of assumed safety of GMOs derives: “modern biotechnology … does not inherently lead to foods that are less safe … . Therefore evaluation of foods and food components obtained from organisms developed by the application of the newer techniques does not necessitate a fundamental change in established principles, nor does it require a different standard of safety” (OECD, “Safety” 10). This was at the time, and remains, an act of faith, a pro-corporatist and a post-cautionary approach. The OECD motto reveals where their priorities lean: “for a better world economy” (OECD, “Better”). The term “substantial equivalence” was preceded by the 1992 USFDA concept of “substantial similarity” (Levidow, Murphy and Carr) and was adopted from a prior usage by the US Food and Drug Agency (USFDA) where it was used pertaining to medical devices (Miller). Even GMO proponents accept that “Substantial equivalence is not intended to be a scientific formulation; it is a conceptual tool for food producers and government regulators” (Miller 1043). And there’s the rub – there is no scientific definition of “substantial equivalence”, no scientific test of proof of concept, and nor is there likely to be, since this is a ‘spinmeister’ term. And yet this is the cornerstone on which rests the presumption of safety of GMOs. Absence of evidence is taken to be evidence of absence. History suggests that this is a fraught presumption. By way of contrast, the patenting of GMOs depends on the antithesis of assumed ‘sameness’. Patenting rests on proven, scrutinised, challengeable and robust tests of difference and novelty. Lightfoot et al. report that transgenic plants exhibit “unexpected changes [that] challenge the usual assumptions of GMO equivalence and suggest genomic, proteomic and metanomic characterization of transgenics is advisable” (1). GMO Milk and Contested Labelling Pesticide company Monsanto markets the genetically engineered hormone rBST (recombinant Bovine Somatotropin; also known as: rbST; rBGH, recombinant Bovine Growth Hormone; and the brand name Prosilac) to dairy farmers who inject it into their cows to increase milk production. This product is not approved for use in many jurisdictions, including Europe, Australia, New Zealand, Canada and Japan. Even Monsanto accepts that rBST leads to mastitis (inflammation and pus in the udder) and other “cow health problems”, however, it maintains that “these problems did not occur at rates that would prohibit the use of Prosilac” (Monsanto). A European Union study identified an extensive list of health concerns of rBST use (European Commission). The US Dairy Export Council however entertain no doubt. In their background document they ask “is milk from cows treated with rBST safe?” and answer “Absolutely” (USDEC). Meanwhile, Monsanto’s website raises and answers the question: “Is the milk from cows treated with rbST any different from milk from untreated cows? No” (Monsanto). Injecting cows with genetically modified hormones to boost their milk production remains a contested practice, banned in many countries. It is the claimed equivalence that has kept consumers of US dairy products in the dark, shielded rBST dairy farmers from having to declare that their milk production is GMO-enhanced, and has inhibited non-GMO producers from declaring their milk as non-GMO, non rBST, or not hormone enhanced. This is a battle that has simmered, and sometimes raged, for a decade in the US. Finally there is a modest victory for consumers: the Pennsylvania Department of Agriculture (PDA) requires all labels used on milk products to be approved in advance by the department. The standard issued in October 2007 (PDA, “Standards”) signalled to producers that any milk labels claiming rBST-free status would be rejected. This advice was rescinded in January 2008 with new, specific, department-approved textual constructions allowed, and ensuring that any “no rBST” style claim was paired with a PDA-prescribed disclaimer (PDA, “Revised Standards”). However, parsimonious labelling is prohibited: No labeling may contain references such as ‘No Hormones’, ‘Hormone Free’, ‘Free of Hormones’, ‘No BST’, ‘Free of BST’, ‘BST Free’,’No added BST’, or any statement which indicates, implies or could be construed to mean that no natural bovine somatotropin (BST) or synthetic bovine somatotropin (rBST) are contained in or added to the product. (PDA, “Revised Standards” 3) Difference claims are prohibited: In no instance shall any label state or imply that milk from cows not treated with recombinant bovine somatotropin (rBST, rbST, RBST or rbst) differs in composition from milk or products made with milk from treated cows, or that rBST is not contained in or added to the product. If a product is represented as, or intended to be represented to consumers as, containing or produced from milk from cows not treated with rBST any labeling information must convey only a difference in farming practices or dairy herd management methods. (PDA, “Revised Standards” 3) The PDA-approved labelling text for non-GMO dairy farmers is specified as follows: ‘From cows not treated with rBST. No significant difference has been shown between milk derived from rBST-treated and non-rBST-treated cows’ or a substantial equivalent. Hereinafter, the first sentence shall be referred to as the ‘Claim’, and the second sentence shall be referred to as the ‘Disclaimer’. (PDA, “Revised Standards” 4) It is onto the non-GMO dairy farmer alone, that the costs of compliance fall. These costs include label preparation and approval, proving non-usage of GMOs, and of creating and maintaining an audit trail. In nearby Ohio a similar consumer versus corporatist pantomime is playing out. This time with the Ohio Department of Agriculture (ODA) calling the shots, and again serving the GMO industry. The ODA prescribed text allowed to non-GMO dairy farmers is “from cows not supplemented with rbST” and this is to be conjoined with the mandatory disclaimer “no significant difference has been shown between milk derived from rbST-supplemented and non-rbST supplemented cows” (Curet). These are “emergency rules”: they apply for 90 days, and are proposed as permanent. Once again, the onus is on the non-GMO dairy farmers to document and prove their claims. GMO dairy farmers face no such governmental requirements, including no disclosure requirement, and thus an asymmetric regulatory impost is placed on the non-GMO farmer which opens up new opportunities for administrative demands and technocratic harassment. Levidow et al. argue, somewhat Eurocentrically, that from its 1990s adoption “as the basis for a harmonized science-based approach to risk assessment” (26) the concept of “substantial equivalence” has “been recast in at least three ways” (58). It is true that the GMO debate has evolved differently in the US and Europe, and with other jurisdictions usually adopting intermediate positions, yet the concept persists. Levidow et al. nominate their three recastings as: firstly an “implicit redefinition” by the appending of “extra phrases in official documents”; secondly, “it has been reinterpreted, as risk assessment processes have … required more evidence of safety than before, especially in Europe”; and thirdly, “it has been demoted in the European Union regulatory procedures so that it can no longer be used to justify the claim that a risk assessment is unnecessary” (58). Romeis et al. have proposed a decision tree approach to GMO risks based on cascading tiers of risk assessment. However what remains is that the defects of the concept of “substantial equivalence” persist. Schauzu identified that: such decisions are a matter of “opinion”; that there is “no clear definition of the term ‘substantial’”; that because genetic modification “is aimed at introducing new traits into organisms, the result will always be a different combination of genes and proteins”; and that “there is no general checklist that could be followed by those who are responsible for allowing a product to be placed on the market” (2). Benchmark for Further Food Novelties? The discourse, contestation, and debate about “substantial equivalence” have largely focussed on the introduction of GMOs into food production processes. GM can best be regarded as the test case, and proof of concept, for establishing “substantial equivalence” as a benchmark for evaluating new and forthcoming food technologies. This is of concern, because the concept of “substantial equivalence” is scientific hokum, and yet its persistence, even entrenchment, within regulatory agencies may be a harbinger of forthcoming same-but-different debates for nanotechnology and other future bioengineering. The appeal of “substantial equivalence” has been a brake on the creation of GMO-specific regulations and on rigorous GMO testing. The food nanotechnology industry can be expected to look to the precedent of the GMO debate to head off specific nano-regulations and nano-testing. As cloning becomes economically viable, then this may be another wave of food innovation that muddies the regulatory waters with the confused – and ultimately self-contradictory – concept of “substantial equivalence”. Nanotechnology engineers particles in the size range 1 to 100 nanometres – a nanometre is one billionth of a metre. This is interesting for manufacturers because at this size chemicals behave differently, or as the Australian Office of Nanotechnology expresses it, “new functionalities are obtained” (AON). Globally, government expenditure on nanotechnology research reached US$4.6 billion in 2006 (Roco 3.12). While there are now many patents (ETC Group; Roco), regulation specific to nanoparticles is lacking (Bowman and Hodge; Miller and Senjen). The USFDA advises that nano-manufacturers “must show a reasonable assurance of safety … or substantial equivalence” (FDA). A recent inventory of nano-products already on the market identified 580 products. Of these 11.4% were categorised as “Food and Beverage” (WWICS). This is at a time when public confidence in regulatory bodies is declining (HRA). In an Australian consumer survey on nanotechnology, 65% of respondents indicated they were concerned about “unknown and long term side effects”, and 71% agreed that it is important “to know if products are made with nanotechnology” (MARS 22). Cloned animals are currently more expensive to produce than traditional animal progeny. In the course of 678 pages, the USFDA Animal Cloning: A Draft Risk Assessment has not a single mention of “substantial equivalence”. However the Federation of Animal Science Societies (FASS) in its single page “Statement in Support of USFDA’s Risk Assessment Conclusion That Food from Cloned Animals Is Safe for Human Consumption” states that “FASS endorses the use of this comparative evaluation process as the foundation of establishing substantial equivalence of any food being evaluated. It must be emphasized that it is the food product itself that should be the focus of the evaluation rather than the technology used to generate cloned animals” (FASS 1). Contrary to the FASS derogation of the importance of process in food production, for consumers both the process and provenance of production is an important and integral aspect of a food product’s value and identity. Some consumers will legitimately insist that their Kalamata olives are from Greece, or their balsamic vinegar is from Modena. It was the British public’s growing awareness that their sugar was being produced by slave labour that enabled the boycotting of the product, and ultimately the outlawing of slavery (Hochschild). When consumers boycott Nestle, because of past or present marketing practices, or boycott produce of USA because of, for example, US foreign policy or animal welfare concerns, they are distinguishing the food based on the narrative of the food, the production process and/or production context which are a part of the identity of the food. Consumers attribute value to food based on production process and provenance information (Paull). Products produced by slave labour, by child labour, by political prisoners, by means of torture, theft, immoral, unethical or unsustainable practices are different from their alternatives. The process of production is a part of the identity of a product and consumers are increasingly interested in food narrative. It requires vigilance to ensure that these narratives are delivered with the product to the consumer, and are neither lost nor suppressed. Throughout the GM debate, the organic sector has successfully skirted the “substantial equivalence” debate by excluding GMOs from the certified organic food production process. This GMO-exclusion from the organic food stream is the one reprieve available to consumers worldwide who are keen to avoid GMOs in their diet. The organic industry carries the expectation of providing food produced without artificial pesticides and fertilizers, and by extension, without GMOs. Most recently, the Soil Association, the leading organic certifier in the UK, claims to be the first organisation in the world to exclude manufactured nonoparticles from their products (Soil Association). There has been the call that engineered nanoparticles be excluded from organic standards worldwide, given that there is no mandatory safety testing and no compulsory labelling in place (Paull and Lyons). The twisted rhetoric of oxymorons does not make the ideal foundation for policy. Setting food policy on the shifting sands of “substantial equivalence” seems foolhardy when we consider the potentially profound ramifications of globally mass marketing a dysfunctional food. If there is a 2×2 matrix of terms – “substantial equivalence”, substantial difference, insubstantial equivalence, insubstantial difference – while only one corner of this matrix is engaged for food policy, and while the elements remain matters of opinion rather than being testable by science, or by some other regime, then the public is the dupe, and potentially the victim. “Substantial equivalence” has served the GMO corporates well and the public poorly, and this asymmetry is slated to escalate if nano-food and clone-food are also folded into the “substantial equivalence” paradigm. Only in Orwellian Newspeak is war peace, or is same different. It is time to jettison the pseudo-scientific doctrine of “substantial equivalence”, as a convenient oxymoron, and embrace full disclosure of provenance, process and difference, so that consumers are not collateral in a continuing asymmetric knowledge war. References Australian Office of Nanotechnology (AON). 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