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"Rich McWhae" (2019-03-02)


international travel health insuranceQuestion 1
The FDA Food Safety Modernization Act (FSMA) is one of the current legislation that gives authority to the Food and Drug Administration to strengthen food safety systems in order to better protect public health. The Act was signed into law by on Jan. 4, 2011. It enables the agency to focus more on preventing food safety problems by providing new enforcement authorities necessary to realize higher rates of compliance with safety standards. The law also gives the agency important tools to build an integrated national food safety system in collaboration with local and state authorities. The Act Sec. 102: Registration of food facilities requires FDA to undertake rulemaking and issue regulations as well as guidance documents. The rulemaking authority will reduce foodborne diseases.
Question 2
The first step in the rulemaking process begins with the Congress. After the Congress passes the statute, the second step is the development of draft proposed rule by the Agency. The third step involves the review or approval of draft with an agency. The fourth step is a review of the draft by OMB/OIR. The fifth step involves publication of notice of proposed rulemaking. The sixth step involves obtaining public comments. The seventh step involves the development of draft final rule as well as response to comments. The eighth step is the approval of draft final rule within an agency. A review of draft final rule by OMB/OIRA is conducted as the ninth step. Publication of the rule follows before the rule takes effect. In certain circumstances, several steps may be skipped. Other rules may be published several times to capture public comments (Copeland, 2005). The involvement of the public in the process increases fairness. Reduction of the number of constraints imposed on rulemaking requirements would increase the fairness of the process. Scientific evidence provides facts that can point out potential implications of the rule. I believe that number of scientific evidence necessary should depend on the issue in question as some issues would require more scientific evidence as their implementation would result in a significant impact. The validity reliability of evidence depends on various factors including sample size, method of data collection, approach and the interest of parties involved.

References
Copeland, C. W. (2005). The Federal Rulemaking Process: An Overview. Congressional Research Service, the Library of Congress.
Monheit, A. C., Cantor, J. C., DeLia, D., & Belloff, D. (2011). How have state policies to expand dependent coverage affected the health insurance status of young adults?. Health services research, 46(1p2), 251-267.
Oregon Health Authority (2014, September) HB 2348 Task Force Report: Future of Public international travel health insurance Services