Implementing the National Bioengineered Food Disclosure Standard

In July 2016, the National Bioengineered Food Disclosure Law was passed to establish a mandatory national system for disclosing the presence of genetically-engineered material in food (GMOs). The federal law preempts state and local initiatives to create labeling systems. This essay first analyzes the benefits and drawbacks of having a national GMO law rather than a patchwork of state laws. Then it provides commentary on how the USDA can create an effective and accessible labeling system, using scannable Quick Response (QR) codes.. The essay envisions a retail food system in which all consumers can easily and usefully obtain reliable information about GMO content and potentially other food characteristics

Regulation by Third-Party Verification

This Article proposes greater governmental reliance on private auditors to enhance the achievement of regulatory objectives. Regulatory failure is a growing problem as governmental agencies lack resources to adequately monitor and detect noncompliance. Third-party verification partially privatizes the regulatory function by requiring regulated entities to hire independent third parties to verify compliance data and make compliance determinations. As a type of privatization, third-party verification presents both opportunities and potential problems. The key issue, as in other forms of public-private governance, is ensuring that accountability and other public values are protected when private actors perform functions that are fundamentally public. This Article argues that, as third-party verification is incorporated into regulatory frameworks, it must be carefully regulated itself. Regulatory agencies must assume the role of “auditing the auditors” through making and enforcing rules that govern who can serve as a verifier, how regulated entities select verifiers, and how verifications are performed. With well-designed rules and strong governmental oversight, third-party verification has the potential to cost-effectively improve the implementation of social regulation

Harnessing Private Regulation

In private regulation, private actors make, implement, and enforce rules that serve traditional public goals. While private safety standards have a long history, private social and environmental regulation in the forms of self-regulation, sup-ply chain contracting, and voluntary certification and labeling programs have proliferated in the past couple decades. This expansion of private regulation raises the question of how it might be harnessed by public actors to build better regula-tory regimes. This Article tackles this question first by identifying three forms of strong harnessing: public incorporation of private standards, public endorsement of self-regulation, and third-party verification. It then analyzes eight third-party verification programs established by six federal regulatory agencies to derive les-sons about what makes a program successful and to develop recommendations to federal agencies about when and how they should use third-party verification

Enforcing Cap-and-Trade: A Tale of Two Programs

This Article uses the histories of the ARP and RECLAIM to show that even when monitoring and enforcement provisions for cap-and-trade programs are designed in a similar way, the resulting enforcement systems and enforcement outcomes may be very different. Part I of the Article tells the enforcement story of the ARP. It appears to be a story of regulatory efficiency and success. Part II tells the enforcement story of RECLAIM. While not a failure, RECLAIM enforcement seems to have been full of difficulties that necessitated large amounts of administrative time and resources. This part presents the results of an empirical analysis of RECLAIM enforcement actions from 1994 through 2006. The analysis shows that RECLAIM had many more enforcement actions than the ARP, despite the fact that the ARP was a much larger cap-and-trade program in terms of the volume of pollution regulated. Similarly, the amount of monetary penalties assessed in RECLAIM for non-compliance was much larger than the amount assessed in the ARP

Regional Climate Regulation: From State Competition to State Collaboration

States have often been theorized to act as competitors in crafting their environmental policies, engaging in either a “race to the bottom” or a “race to the top.” In the recent development of climate law, however, it is state collaboration and cooperation rather than state competition that have emerged most strongly. This Article first discusses how the theories of competitive state behavior would have predicted states to behave in the absence of federal action and describes the contrasting extent to which states have engaged in collaborative initiatives. The Article then analyzes why states have been motivated to collaborate in climate law

Harnessing Private Regulation

In private regulation, private actors make, implement, and enforce rules that serve traditional public goals. While private safety standards have a long history, private social and environmental regulation in the forms of self-regulation, sup-ply chain contracting, and voluntary certification and labeling programs have proliferated in the past couple decades. This expansion of private regulation raises the question of how it might be harnessed by public actors to build better regula-tory regimes. This Article tackles this question first by identifying three forms of strong harnessing: public incorporation of private standards, public endorsement of self-regulation, and third-party verification. It then analyzes eight third-party verification programs established by six federal regulatory agencies to derive les-sons about what makes a program successful and to develop recommendations to federal agencies about when and how they should use third-party verification

Duration of androgen deprivation therapy with postoperative radiotherapy for prostate cancer: a comparison of long-course versus short-course androgen deprivation therapy in the RADICALS-HD randomised trial

Background Previous evidence supports androgen deprivation therapy (ADT) with primary radiotherapy as initial treatment for intermediate-risk and high-risk localised prostate cancer. However, the use and optimal duration of ADT with postoperative radiotherapy after radical prostatectomy remains uncertain. Methods RADICALS-HD was a randomised controlled trial of ADT duration within the RADICALS protocol. Here, we report on the comparison of short-course versus long-course ADT. Key eligibility criteria were indication for radiotherapy after previous radical prostatectomy for prostate cancer, prostate-specific antigen less than 5 ng/mL, absence of metastatic disease, and written consent. Participants were randomly assigned (1:1) to add 6 months of ADT (short-course ADT) or 24 months of ADT (long-course ADT) to radiotherapy, using subcutaneous gonadotrophin-releasing hormone analogue (monthly in the short-course ADT group and 3-monthly in the long-course ADT group), daily oral bicalutamide monotherapy 150 mg, or monthly subcutaneous degarelix. Randomisation was done centrally through minimisation with a random element, stratified by Gleason score, positive margins, radiotherapy timing, planned radiotherapy schedule, and planned type of ADT, in a computerised system. The allocated treatment was not masked. The primary outcome measure was metastasis-free survival, defined as metastasis arising from prostate cancer or death from any cause. The comparison had more than 80% power with two-sided α of 5% to detect an absolute increase in 10-year metastasis-free survival from 75% to 81% (hazard ratio [HR] 0·72). Standard time-to-event analyses were used. Analyses followed intention-to-treat principle. The trial is registered with the ISRCTN registry, ISRCTN40814031, and ClinicalTrials.gov , NCT00541047 . Findings Between Jan 30, 2008, and July 7, 2015, 1523 patients (median age 65 years, IQR 60–69) were randomly assigned to receive short-course ADT (n=761) or long-course ADT (n=762) in addition to postoperative radiotherapy at 138 centres in Canada, Denmark, Ireland, and the UK. With a median follow-up of 8·9 years (7·0–10·0), 313 metastasis-free survival events were reported overall (174 in the short-course ADT group and 139 in the long-course ADT group; HR 0·773 [95% CI 0·612–0·975]; p=0·029). 10-year metastasis-free survival was 71·9% (95% CI 67·6–75·7) in the short-course ADT group and 78·1% (74·2–81·5) in the long-course ADT group. Toxicity of grade 3 or higher was reported for 105 (14%) of 753 participants in the short-course ADT group and 142 (19%) of 757 participants in the long-course ADT group (p=0·025), with no treatment-related deaths. Interpretation Compared with adding 6 months of ADT, adding 24 months of ADT improved metastasis-free survival in people receiving postoperative radiotherapy. For individuals who can accept the additional duration of adverse effects, long-course ADT should be offered with postoperative radiotherapy. Funding Cancer Research UK, UK Research and Innovation (formerly Medical Research Council), and Canadian Cancer Society

Adding 6 months of androgen deprivation therapy to postoperative radiotherapy for prostate cancer: a comparison of short-course versus no androgen deprivation therapy in the RADICALS-HD randomised controlled trial

Background Previous evidence indicates that adjuvant, short-course androgen deprivation therapy (ADT) improves metastasis-free survival when given with primary radiotherapy for intermediate-risk and high-risk localised prostate cancer. However, the value of ADT with postoperative radiotherapy after radical prostatectomy is unclear. Methods RADICALS-HD was an international randomised controlled trial to test the efficacy of ADT used in combination with postoperative radiotherapy for prostate cancer. Key eligibility criteria were indication for radiotherapy after radical prostatectomy for prostate cancer, prostate-specific antigen less than 5 ng/mL, absence of metastatic disease, and written consent. Participants were randomly assigned (1:1) to radiotherapy alone (no ADT) or radiotherapy with 6 months of ADT (short-course ADT), using monthly subcutaneous gonadotropin-releasing hormone analogue injections, daily oral bicalutamide monotherapy 150 mg, or monthly subcutaneous degarelix. Randomisation was done centrally through minimisation with a random element, stratified by Gleason score, positive margins, radiotherapy timing, planned radiotherapy schedule, and planned type of ADT, in a computerised system. The allocated treatment was not masked. The primary outcome measure was metastasis-free survival, defined as distant metastasis arising from prostate cancer or death from any cause. Standard survival analysis methods were used, accounting for randomisation stratification factors. The trial had 80% power with two-sided α of 5% to detect an absolute increase in 10-year metastasis-free survival from 80% to 86% (hazard ratio [HR] 0·67). Analyses followed the intention-to-treat principle. The trial is registered with the ISRCTN registry, ISRCTN40814031, and ClinicalTrials.gov, NCT00541047. Findings Between Nov 22, 2007, and June 29, 2015, 1480 patients (median age 66 years [IQR 61–69]) were randomly assigned to receive no ADT (n=737) or short-course ADT (n=743) in addition to postoperative radiotherapy at 121 centres in Canada, Denmark, Ireland, and the UK. With a median follow-up of 9·0 years (IQR 7·1–10·1), metastasis-free survival events were reported for 268 participants (142 in the no ADT group and 126 in the short-course ADT group; HR 0·886 [95% CI 0·688–1·140], p=0·35). 10-year metastasis-free survival was 79·2% (95% CI 75·4–82·5) in the no ADT group and 80·4% (76·6–83·6) in the short-course ADT group. Toxicity of grade 3 or higher was reported for 121 (17%) of 737 participants in the no ADT group and 100 (14%) of 743 in the short-course ADT group (p=0·15), with no treatment-related deaths. Interpretation Metastatic disease is uncommon following postoperative bed radiotherapy after radical prostatectomy. Adding 6 months of ADT to this radiotherapy did not improve metastasis-free survival compared with no ADT. These findings do not support the use of short-course ADT with postoperative radiotherapy in this patient population