Academic literature on the topic 'Corporation law, pennsylvania'

Abstract Background PF-06838435 (SPK-9001), a gene therapy candidate containing a high specific-activity factor IX variant (R338L, FIX-Padua), is currently in phase 3 of clinical development for the treatment of Hemophilia B. Initial data with this vector is promising with significant reductions in bleeding episodes and FIX consumption (George LA et al, NEJM 2017; 377:2215-2217). To date, little is known about the activity of the expressed transgene product as measured in FIX:C one-stage and chromogenic assay systems commonly used to monitor FIX replacement therapy in patients with Hemophilia B. Aim The goal of the study was to assess the activity of the PF-06838435 expressed transgene product in plasma samples collected from participants in the Phase 1/2 trial using four commonly used FIX:C aPTT reagents. For comparison, the activity of the expressed FIX-Padua gene product was also assessed in the ROX FACTOR IX chromogenic assay. In addition, the activity of the Padua variant in congenital FIX deficient plasma spiked with increasing concentrations of purified recombinant human FIX Padua protein (rHFIXp - Samelson-Jones Lab, CHOP/UPenn), as well as recombinant human FIX (rHFIX, BeneFIX®, Pfizer Inc.), was assessed in the same FIX:C assay procedures. Methods FIX:C, in four samples collected from two different patients who received FIX gene therapy, was tested in four in vitro diagnostic (IVD) approved FIX:C one-stage assay systems, STA®-PTT Automate and STA®-C.K. Prest® on the STA-R Evolution® (Diagnostica Stago Inc.), Dade Actin® FSL on the BCS®XP (Siemens Healthcare), and HemosIL® SynthASil® on the ACL TOP® (Instrumentation Laboratory). In addition, samples were also tested in the ROX FACTOR IX (Rossix AB) chromogenic assay on the BCS®XP (Siemens Healthcare). The aPTT reagents selected for this study correspond to 90% of the FIX:C assay reagents currently used in CAP accredited laboratories in the US(2014 CAP Proficiency Survey) and represent the three main types of activator commonly used in the FIX one-stage clot assay: silica (STA®-PTT Automate, HemosIL® SynthASil®), ellagic acid (Dade Actin® FSL) and kaolin (STA®-C.K. Prest®). For comparison, FIX:C in each of the five FIX:C assay systems was also determined in samples spiked with purified rHFIXp (provided by Dr. Samelson-Jones) or rHFIX (provided by Spark Therapeutics Inc.) in 20X buffer solutions. On the day of testing rHFIXp, and rHFIX 20X buffer solutions were diluted 1:20 in congenital FIX deficient plasma to achieve approximate final FIX:C concentrations of 40, 30 and 20%, extrapolated from an estimated 8-fold specific activity to antigen ratio. Results A consistent pattern in the measured FIX:C for the PF-06838435 transgene product was observed in the five FIX:C assay systems (Fig. 1). For the aPTT based FIX:C assays, Actin FSL, gave the lowest FIX:C values, whereas PTT Automate measured the highest FIX:C levels. In all cases, the chromogenic FIX:C assay gave the lowest activity values for the transgene product. A similar FIX:C assay dependent pattern was observed for the purified rHFIXp spiked at 40, 30 and 20% FIX:C (Fig. 2). In all FIX:C assays tested, rHFIXp was under-recovered to a varying degree from target, with recoveries for the 20% FIX:C samples ranging between -26.5% (STA®-PTT Automate) and -73.5% (Dade Actin® FSL) in the aPTT based FIX:C assays and -85% in the ROX FIX chromogenic assay. In contrast, rHFIX (BeneFIX®) was recovered within ±25% of expected values in all aPTT based FIX:C assays and, consistent with previously reported data, modestly under-recovered in the ROX FIX chromogenic assay (Fig. 3). Conclusion This study found differences in the FIX:C results obtained for a Padua FIX variant transgene product and recombinant human FIX-Padua when tested in commonly used IVD approved FIX:C assays in North America. These results suggest that FIX:C assay selection is important for measuring FIX-Padua activity, which will be particularly relevant in hemophilia B gene therapy following FIX-Padua gene transfer. Disclosures George: University of Pennsylvania: Equity Ownership; Pfizer: Consultancy. High:Spark Therapeutics: Employment, Equity Ownership, Patents & Royalties. Carr:Sparks Therapeutics Inc.: Consultancy. Tiefenbacher:Laboratory Corporation of America: Employment, Equity Ownership; Siemens Healthcare: Consultancy.

In the late summer of 2002, the Pennsylvania charitable trust that controls and owns most of the Hershey Foods Corporation put this American corporate icon and one of the world’s leading food and confectionary conglomerates up for sale. The Hershey Trust, whose legal beneficiary is the local Milton Hershey School for poor and underprivileged children, told workers, managers and the press that it sought to diversify its investment portfolio long concentrated in Hershey Foods stock, and “unlock the value” of its controlling shares in Hershey Foods by taking bids for all of its shares in the company.

IntroductionThe Internet (especially in the so-called Web 2.0 phase), digital media and file-sharing networks have thrust copyright law under public scrutiny, provoking discourses questioning what is fair in the digital age. Accessible hardware and software has led to prosumerism – creativity blending media consumption with media production to create new works that are freely disseminated online via popular video-sharing Web sites such as YouTube or genre specific music sites like GYBO (“Get Your Bootleg On”) amongst many others. The term “prosumer” is older than the Web, and the conceptual convergence of producer and consumer roles is certainly not new, for “at electric speeds the consumer becomes producer as the public becomes participant role player” (McLuhan 4). Similarly, Toffler’s “Third Wave” challenges “old power relationships” and promises to “heal the historic breach between producer and consumer, giving rise to the ‘prosumer’ economics” (27). Prosumption blurs the traditionally separate consumer and producer creating a new creative era of mass customisation of artefacts culled from the (copyrighted) media landscape (Tapscott 62-3). Simultaneously, corporate interests dependent upon the protections provided by copyright law lobby for augmented rights and actively defend their intellectual property through law suits, takedown notices and technological reinforcement. Despite a lack demonstrable economic harm in many cases, the propertarian approach is winning and frequently leading to absurd results (Collins).The balance between private and public interests in creative works is facilitated by the doctrine of fair use (as codified in the United States Copyright Act 1976, section 107). The majority of copyright laws contain “fair” exceptions to claims of infringement, but fair use is characterised by a flexible, open-ended approach that allows the law to flex with the times. Until recently the defence was unique to the U.S., but on 2 January Israel amended its copyright laws to include a fair use defence. (For an overview of the new Israeli fair use exception, see Efroni.) Despite its flexibility, fair use has been systematically eroded by ever encroaching copyrights. This paper argues that copyright enforcement has spun out of control and the raison d’être of the law has shifted from being “an engine of free expression” (Harper & Row, Publishers, Inc. v. Nation Enterprises 471 U.S. 539, 558 (1985)) towards a “legal regime for intellectual property that increasingly looks like the law of real property, or more properly an idealized construct of that law, one in which courts seeks out and punish virtually any use of an intellectual property right by another” (Lemley 1032). Although the copyright landscape appears bleak, two recent cases suggest that fair use has not fallen by the wayside and may well recover. This paper situates fair use as an essential legal and cultural mechanism for optimising creative expression.A Brief History of CopyrightThe law of copyright extends back to eighteenth century England when the Statute of Anne (1710) was enacted. Whilst the length of this paper precludes an in depth analysis of the law and its export to the U.S., it is important to stress the goals of copyright. “Copyright in the American tradition was not meant to be a “property right” as the public generally understands property. It was originally a narrow federal policy that granted a limited trade monopoly in exchange for universal use and access” (Vaidhyanathan 11). Copyright was designed as a right limited in scope and duration to ensure that culturally important creative works were not the victims of monopolies and were free (as later mandated in the U.S. Constitution) “to promote the progress.” During the 18th century English copyright discourse Lord Camden warned against propertarian approaches lest “all our learning will be locked up in the hands of the Tonsons and the Lintons of the age, who will set what price upon it their avarice chooses to demand, till the public become as much their slaves, as their own hackney compilers are” (Donaldson v. Becket 17 Cobbett Parliamentary History, col. 1000). Camden’s sentiments found favour in subsequent years with members of the North American judiciary reiterating that copyright was a limited right in the interests of society—the law’s primary beneficiary (see for example, Wheaton v. Peters 33 US 591 [1834]; Fox Film Corporation v. Doyal 286 US 123 [1932]; US v. Paramount Pictures 334 US 131 [1948]; Mazer v. Stein 347 US 201, 219 [1954]; Twentieth Century Music Corp. v. Aitken 422 U.S. 151 [1975]; Aronson v. Quick Point Pencil Co. 440 US 257 [1979]; Dowling v. United States 473 US 207 [1985]; Harper & Row, Publishers, Inc. v. Nation Enterprises 471 U.S. 539 [1985]; Luther R. Campbell a.k.a. Luke Skyywalker, et al. v. Acuff-Rose Music, Inc. 510 U.S 569 [1994]). Putting the “Fair” in Fair UseIn Folsom v. Marsh 9 F. Cas. 342 (C.C.D. Mass. 1841) (No. 4,901) Justice Storey formulated the modern shape of fair use from a wealth of case law extending back to 1740 and across the Atlantic. Over the course of one hundred years the English judiciary developed a relatively cohesive set of principles governing the use of a first author’s work by a subsequent author without consent. Storey’s synthesis of these principles proved so comprehensive that later English courts would look to his decision for guidance (Scott v. Stanford L.R. 3 Eq. 718, 722 (1867)). Patry explains fair use as integral to the social utility of copyright to “encourage. . . learned men to compose and write useful books” by allowing a second author to use, under certain circumstances, a portion of a prior author’s work, where the second author would himself produce a work promoting the goals of copyright (Patry 4-5).Fair use is a safety valve on copyright law to prevent oppressive monopolies, but some scholars suggest that fair use is less a defence and more a right that subordinates copyrights. Lange and Lange Anderson argue that the doctrine is not fundamentally about copyright or a system of property, but is rather concerned with the recognition of the public domain and its preservation from the ever encroaching advances of copyright (2001). Fair use should not be understood as subordinate to the exclusive rights of copyright owners. Rather, as Lange and Lange Anderson claim, the doctrine should stand in the superior position: the complete spectrum of ownership through copyright can only be determined pursuant to a consideration of what is required by fair use (Lange and Lange Anderson 19). The language of section 107 suggests that fair use is not subordinate to the bundle of rights enjoyed by copyright ownership: “Notwithstanding the provisions of sections 106 and 106A, the fair use of a copyrighted work . . . is not an infringement of copyright” (Copyright Act 1976, s.107). Fair use is not merely about the marketplace for copyright works; it is concerned with what Weinreb refers to as “a community’s established practices and understandings” (1151-2). This argument boldly suggests that judicial application of fair use has consistently erred through subordinating the doctrine to copyright and considering simply the effect of the appropriation on the market place for the original work.The emphasis on economic factors has led courts to sympathise with copyright owners leading to a propertarian or Blackstonian approach to copyright (Collins; Travis) propagating the myth that any use of copyrighted materials must be licensed. Law and media reports alike are potted with examples. For example, in Bridgeport Music, Inc., et al v. Dimension Films et al 383 F. 3d 400 (6th Cir. 2004) a Sixth Circuit Court of Appeals held that the transformative use of a three-note guitar sample infringed copyrights and that musicians must obtain licence from copyright owners for every appropriated audio fragment regardless of duration or recognisability. Similarly, in 2006 Christopher Knight self-produced a one-minute television advertisement to support his campaign to be elected to the board of education for Rockingham County, North Carolina. As a fan of Star Wars, Knight used a makeshift Death Star and lightsaber in his clip, capitalising on the imagery of the Jedi Knight opposing the oppressive regime of the Empire to protect the people. According to an interview in The Register the advertisement was well received by local audiences prompting Knight to upload it to his YouTube channel. Several months later, Knight’s clip appeared on Web Junk 2.0, a cable show broadcast by VH1, a channel owned by media conglomerate Viacom. Although his permission was not sought, Knight was pleased with the exposure, after all “how often does a local school board ad wind up on VH1?” (Metz). Uploading the segment of Web Junk 2.0 featuring the advertisement to YouTube, however, led Viacom to quickly issue a take-down notice citing copyright infringement. Knight expressed his confusion at the apparent unfairness of the situation: “Viacom says that I can’t use my clip showing my commercial, claiming copy infringement? As we say in the South, that’s ass-backwards” (Metz).The current state of copyright law is, as Patry says, “depressing”:We are well past the healthy dose stage and into the serious illness stage ... things are getting worse, not better. Copyright law has abandoned its reason for being: to encourage learning and the creation of new works. Instead, its principal functions now are to preserve existing failed business models, to suppress new business models and technologies, and to obtain, if possible, enormous windfall profits from activity that not only causes no harm, but which is beneficial to copyright owners. Like Humpty-Dumpty, the copyright law we used to know can never be put back together.The erosion of fair use by encroaching private interests represented by copyrights has led to strong critiques leveled at the judiciary and legislators by Lessig, McLeod and Vaidhyanathan. “Free culture” proponents warn that an overly strict copyright regime unbalanced by an equally prevalent fair use doctrine is dangerous to creativity, innovation, culture and democracy. After all, “few, if any, things ... are strictly original throughout. Every book in literature, science and art, borrows, and must necessarily borrow, and use much which was well known and used before. No man creates a new language for himself, at least if he be a wise man, in writing a book. He contents himself with the use of language already known and used and understood by others” (Emerson v. Davis, 8 F. Cas. 615, 619 (No. 4,436) (CCD Mass. 1845), qted in Campbell v. Acuff-Rose, 62 U.S.L.W. at 4171 (1994)). The rise of the Web 2.0 phase with its emphasis on end-user created content has led to an unrelenting wave of creativity, and much of it incorporates or “mashes up” copyright material. As Negativland observes, free appropriation is “inevitable when a population bombarded with electronic media meets the hardware [and software] that encourages them to capture it” and creatively express themselves through appropriated media forms (251). The current state of copyright and fair use is bleak, but not beyond recovery. Two recent cases suggest a resurgence of the ideology underpinning the doctrine of fair use and the role played by copyright.Let’s Go CrazyIn “Let’s Go Crazy #1” on YouTube, Holden Lenz (then eighteen months old) is caught bopping to a barely recognizable recording of Prince’s “Let’s Go Crazy” in his mother’s Pennsylvanian kitchen. The twenty-nine second long video was viewed a mere twenty-eight times by family and friends before Stephanie Lenz received an email from YouTube informing her of its compliance with a Digital Millennium Copyright Act (DMCA) take-down notice issued by Universal, copyright owners of Prince’s recording (McDonald). Lenz has since filed a counterclaim against Universal and YouTube has reinstated the video. Ironically, the media exposure surrounding Lenz’s situation has led to the video being viewed 633,560 times at the time of writing. Comments associated with the video indicate a less than reverential opinion of Prince and Universal and support the fairness of using the song. On 8 Aug. 2008 a Californian District Court denied Universal’s motion to dismiss Lenz’s counterclaim. The question at the centre of the court judgment was whether copyright owners should consider “the fair use doctrine in formulating a good faith belief that use of the material in the manner complained of is not authorized by the copyright owner, its agent, or the law.” The court ultimately found in favour of Lenz and also reaffirmed the position of fair use in relation to copyright. Universal rested its argument on two key points. First, that copyright owners cannot be expected to consider fair use prior to issuing takedown notices because fair use is a defence, invoked after the act rather than a use authorized by the copyright owner or the law. Second, because the DMCA does not mention fair use, then there should be no requirement to consider it, or at the very least, it should not be considered until it is raised in legal defence.In rejecting both arguments the court accepted Lenz’s argument that fair use is an authorised use of copyrighted materials because the doctrine of fair use is embedded into the Copyright Act 1976. The court substantiated the point by emphasising the language of section 107. Although fair use is absent from the DMCA, the court reiterated that it is part of the Copyright Act and that “notwithstanding the provisions of sections 106 and 106A” a fair use “is not an infringement of copyright” (s.107, Copyright Act 1976). Overzealous rights holders frequently abuse the DMCA as a means to quash all use of copyrighted materials without considering fair use. This decision reaffirms that fair use “should not be considered a bizarre, occasionally tolerated departure from the grand conception of the copyright design” but something that it is integral to the constitution of copyright law and essential in ensuring that copyright’s goals can be fulfilled (Leval 1100). Unlicensed musical sampling has never fared well in the courtroom. Three decades of rejection and admonishment by judges culminated in Bridgeport Music, Inc., et al v. Dimension Films et al 383 F. 3d 400 (6th Cir. 2004): “Get a license or do not sample. We do not see this stifling creativity in any significant way” was the ruling on an action brought against an unlicensed use of a three-note guitar sample under section 114, an audio piracy provision. The Bridgeport decision sounded a death knell for unlicensed sampling, ensuring that only artists with sufficient capital to pay the piper could legitimately be creative with the wealth of recorded music available. The cost of licensing samples can often outweigh the creative merit of the act itself as discussed by McLeod (86) and Beaujon (25). In August 2008 the Supreme Court of New York heard EMI v. Premise Media in which EMI sought an injunction against an unlicensed fifteen second excerpt of John Lennon’s “Imagine” featured in Expelled: No Intelligence Allowed, a controversial documentary canvassing alleged chilling of intelligent design proponents in academic circles. (The family of John Lennon and EMI had previously failed to persuade a Manhattan federal court in a similar action.) The court upheld Premise Media’s arguments for fair use and rejected the Bridgeport approach on which EMI had rested its entire complaint. Justice Lowe criticised the Bridgeport court for its failure to examine the legislative intent of section 114 suggesting that courts should look to the black letter of the law rather than blindly accept propertarian arguments. This decision is of particular importance because it establishes that fair use applies to unlicensed use of sound recordings and re-establishes de minimis use.ConclusionThis paper was partly inspired by the final entry on eminent copyright scholar William Patry’s personal copyright law blog (1 Aug. 2008). A copyright lawyer for over 25 years, Patry articulated his belief that copyright law has swung too far away from its initial objectives and that balance could never be restored. The two cases presented in this paper demonstrate that fair use – and therefore balance – can be recovered in copyright. The federal Supreme Court and lower courts have stressed that copyright was intended to promote creativity and have upheld the fair doctrine, but in order for the balance to exist in copyright law, cases must come before the courts; copyright myth must be challenged. As McLeod states, “the real-world problems occur when institutions that actually have the resources to defend themselves against unwarranted or frivolous lawsuits choose to take the safe route, thus eroding fair use”(146-7). ReferencesBeaujon, Andrew. “It’s Not the Beat, It’s the Mocean.” CMJ New Music Monthly. April 1999.Collins, Steve. “Good Copy, Bad Copy: Covers, Sampling and Copyright.” M/C Journal 8.3 (2005). 26 Aug. 2008 ‹http://journal.media-culture.org.au/0507/02-collins.php›.———. “‘Property Talk’ and the Revival of Blackstonian Copyright.” M/C Journal 9.4 (2006). 26 Aug. 2008 ‹http://journal.media-culture.org.au/0609/5-collins.php›.Donaldson v. Becket 17 Cobbett Parliamentary History, col. 953.Efroni, Zohar. “Israel’s Fair Use.” The Center for Internet and Society (2008). 26 Aug. 2008 ‹http://cyberlaw.stanford.edu/node/5670›.Lange, David, and Jennifer Lange Anderson. “Copyright, Fair Use and Transformative Critical Appropriation.” Conference on the Public Domain, Duke Law School. 2001. 26 Aug. 2008 ‹http://www.law.duke.edu/pd/papers/langeand.pdf›.Lemley, Mark. “Property, Intellectual Property, and Free Riding.” Texas Law Review 83 (2005): 1031.Lessig, Lawrence. The Future of Ideas. New York: Random House, 2001.———. Free Culture. New York: Penguin, 2004.Leval, Pierre. “Toward a Fair Use Standard.” Harvard Law Review 103 (1990): 1105.McDonald, Heather. “Holden Lenz, 18 Months, versus Prince and Universal Music Group.” About.com: Music Careers 2007. 26 Aug. 2008 ‹http://musicians.about.com/b/2007/10/27/holden-lenz-18-months-versus-prince-and-universal-music-group.htm›.McLeod, Kembrew. “How Copyright Law Changed Hip Hop: An interview with Public Enemy’s Chuck D and Hank Shocklee.” Stay Free 2002. 26 Aug. 2008 ‹http://www.stayfreemagazine.org/archives/20/public_enemy.html›.———. Freedom of Expression: Overzealous Copyright Bozos and Other Enemies of Creativity. United States: Doubleday, 2005.McLuhan, Marshall, and Barrington Nevitt. Take Today: The Executive as Dropout. Ontario: Longman Canada, 1972.Metz, Cade. “Viacom Slaps YouTuber for Behaving like Viacom.” The Register 2007. 26 Aug. 2008 ‹http://www.theregister.co.uk/2007/08/30/viacom_slaps_pol/›.Negativland, ed. Fair Use: The Story of the Letter U and the Numeral 2. Concord: Seeland, 1995.Patry, William. The Fair Use Privilege in Copyright Law. Washington DC: Bureau of National Affairs, 1985.———. “End of the Blog.” The Patry Copyright Blog. 1 Aug. 2008. 27 Aug. 2008 ‹http://williampatry.blogspot.com/2008/08/end-of-blog.html›.Tapscott, Don. The Digital Economy: Promise and Peril in the Age of Networked Intelligence. New York: McGraw Hill, 1996.Toffler, Alvin. The Third Wave. London, Glasgow, Sydney, Auckland. Toronto, Johannesburg: William Collins, 1980.Travis, Hannibal. “Pirates of the Information Infrastructure: Blackstonian Copyright and the First Amendment.” Berkeley Technology Law Journal, Vol. 15 (2000), No. 777.Vaidhyanathan, Siva. Copyrights and Copywrongs: The Rise of Intellectual Property and How It Threatens Creativity. New York; London: New York UP, 2003.

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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Ottawa: Action Group on Erosion, Technology and Conservation, November, 2004. European Commission. Report on Public Health Aspects of the Use of Bovine Somatotropin. Brussels: European Commission, 15-16 March 1999.Federation of Animal Science Societies (FASS). Statement in Support of FDA’s Risk Assessment Conclusion That Cloned Animals Are Safe for Human Consumption. 2007. 24 Apr. 2008 < http://www.fass.org/page.asp?pageID=191 >.Grist, Stuart. “True Threats to Reason.” New Scientist 197.2643 (16 Feb. 2008): 22-23.Hochschild, Adam. Bury the Chains: The British Struggle to Abolish Slavery. London: Pan Books, 2006.Horsch, Robert, Robert Fraley, Stephen Rogers, Patricia Sanders, Alan Lloyd, and Nancy Hoffman. “Inheritance of Functional Foreign Genes in Plants.” Science 223 (1984): 496-498.HRA. Awareness of and Attitudes toward Nanotechnology and Federal Regulatory Agencies: A Report of Findings. Washington: Peter D. Hart Research Associates, 25 Sep. 2007.Levidow, Les, Joseph Murphy, and Susan Carr. “Recasting ‘Substantial Equivalence’: Transatlantic Governance of GM Food.” Science, Technology, and Human Values 32.1 (Jan. 2007): 26-64.Lightfoot, David, Rajsree Mungur, Rafiqa Ameziane, Anthony Glass, and Karen Berhard. “Transgenic Manipulation of C and N Metabolism: Stretching the GMO Equivalence.” American Society of Plant Biologists Conference: Plant Biology, 2000.MARS. “Final Report: Australian Community Attitudes Held about Nanotechnology – Trends 2005-2007.” Report prepared for Department of Industry, Tourism and Resources (DITR). Miranda, NSW: Market Attitude Research Services, 12 June 2007.Miller, Georgia, and Rye Senjen. “Out of the Laboratory and on to Our Plates: Nanotechnology in Food and Agriculture.” Friends of the Earth, 2008. 24 Apr. 2008 < http://nano.foe.org.au/node/220 >.Miller, Henry. “Substantial Equivalence: Its Uses and Abuses.” Nature Biotechnology 17 (7 Nov. 1999): 1042-1043.Millstone, Erik, Eric Brunner, and Sue Mayer. “Beyond ‘Substantial Equivalence’.” Nature 401 (7 Oct. 1999): 525-526.Monsanto. “Posilac, Bovine Somatotropin by Monsanto: Questions and Answers about bST from the United States Food and Drug Administration.” 2007. 24 Apr. 2008 < http://www.monsantodairy.com/faqs/fda_safety.html >.Organisation for Economic Co-operation and Development (OECD). “For a Better World Economy.” Paris: OECD, 2008. 24 Apr. 2008 < http://www.oecd.org/ >.———. “Safety Evaluation of Foods Derived by Modern Biotechnology: Concepts and Principles.” Paris: OECD, 1993.Orwell, George. Animal Farm. 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Northeastern Pennsylvania has undergone long-term deindustrialization, and the region has one of the highest unemployment rates in the nation. In the late 1990s, the Commonwealth of Pennsylvania provided major tax breaks to corporations, and many companies moved their fulfillment centers to the region. Latinos, mostly of Dominican descent, have migrated to the area to fill these low-skilled positions. As a result, Hazleton’s Latino population has risen from 4 percent in 2000 to 37 percent in 2010, and by 2020 it will be a majority minority community. Fearing undocumented workers, the City of Hazleton passed anti-immigration laws, which have helped fuel anti-immigration sentiment across the United States. The memory of Lattimer and recognition of the undocumented status of the victims have been employed to protest this type of legislation.

In this chapter, the authors present the rapid rise of Massive Open Online Courses (MOOCs) derived from a yearning to create and make widely available materials and conditions for participatory learning and creative space dedicated to the open education. Massive Open Online Courses (MOOCs) were developed to provide open, meaning unrestricted, online courses without higher education cost constraints to students. This new technological platform was embraced, developed, and offered by some of the country's leading universities and institutions including Harvard, University of Pennsylvania, Stanford, and Massachusetts Institute of Technology (MIT). Students may collaborate through strategic social media platforms such as LinkedIn, Facebook, and Twitter. Further, according to LeCounte et al. (2014), the social media partnerships have been found to offer competitive advantages in terms of low cost and tremendous visibility to both corporations and institutions of higher learning.

Over the past decade, members of the Upgraded Coal Interest Group and EPRI, the Department of Energy, the Energy and Environmental Research Corporation (GE-EER), Washington Energy Processing (WEP), Penn State University and the previous owners and operators of Seward Station located in western Pennsylvania, conducted a series of formulation and combustion tests using coal waste fines as a low solids coal water slurry cofiring fuel for electric power generation. The fine coal was recovered from coal fines impoundments and fresh coal cleaning plant fines that were cleaned, thickened and then cofired with pulverized coal in utility scale boilers. This paper explains the need for a program to eliminate these impoundments and describes the results of some of the tests conducted on the technology that demonstrate the effectiveness of trimming NOx emissions by the use of slurry cofiring. This method of trimming NOx emission has been shown to have the capability of reducing NOx emissions by 20% to 35% below the levels achieved by some low NOx burners and selective non-catalytic reduction systems (SNCRs).