Regulatory science requirements of labeling of genetically modified food.

This paper provides an overview of the evolution of food labeling in the USA. It briefly describes the three phases of agricultural development consisting of naturally occurring, cross-bred, and genetically engineered, edited or modified crops, otherwise known as Genetically Modified Organisms (GMO). It uses the Best Available Regulatory Science (BARS) and Metrics for Evaluation of Regulatory Science Claims (MERSC) to evaluate the scientific validity of claims applicable to GMO and the Best Available Public Information (BAPI) to evaluate the pronouncements by public media and others. Subsequently claims on health risk, ecological risk, consumer choice, and corporate greed are evaluated based on BARS/MERSC and BAPI. The paper concludes by suggesting that labeling of food containing GMO should consider the consumer's choice, such as the food used by those who desire kosher and halal food. Furthermore, the consumer choice is already met by the exclusion of GMO in organic food.

Comprehensive Analysis of 13,897 Consecutive Regional Anesthetics at an Ambulatory Surgery Center.

Objective: The authors investigated a wide range of perioperative outcome measures in the context of a robust regional anesthesia practice. Design: Comprehensive review of a prospectively collected six-year database. Setting: Freestanding, academic ambulatory surgery center. Subjects: There were 13,897 consecutive regional anesthetics in 10,338 patients. Methods: We investigated patient satisfaction, postoperative nausea and vomiting (PONV), postoperative pain, catheter analgesia, and complications. Clinical risk factors were examined and presented as odds ratios for multiple outcome analyses including block success, patient satisfaction, PONV, and postoperative neurologic symptoms (PONS). Results: Decreased block success was associated with nerve stimulation alone (P < 0.001), obesity (P = 0.001), higher American Society of Anesthesiologists classification (ASA; P = 0.01), lower extremity blocks (P = 0.04), and male sex (P < 0.001). Decreased patient satisfaction was associated with poor catheter analgesia (P < 0.001), complications (P < 0.001), higher ASA (P = 0.001), and younger age (P = 0.008). PONV was associated with postoperative pain (P < 0.005), female sex (P < 0.001), general anesthesia (P < 0.001), younger age (P = 0.001), lack of catheter (P = 0.03), and lack of dexamethasone/clonidine (D + C) adjuncts (P = 0.01). Serious complications and unexpected hospitalizations were rare (<0.2%). D + C adjuncts, lower extremity blocks, clonidine (but not dexamethasone alone), and female sex were associated with PONS (all P < 0.001). Conclusions: A regional anesthesia-based practice in ambulatory surgery is an effective means of providing excellent postoperative analgesia and is associated with a low rate of PONV and unexpected admissions. Dexamethasone, clonidine, and their combination when combined with 0.5% ropivacaine may have mixed effects on PONS risk that warrant dose/concentration alterations of these three drugs in the context of off-label perineural adjunct use.