Meaning of Hermeneutics.Pdf

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Analysis of the Food Safety Modernization Act
The U.S. Congress passed the Food Safety Modernization Act in December. The congressional process was neither fast nor pretty. First caught behind health care reform and then squeezed into the post-election congressional wrap up, President Barack Obama signed food safety bill in early January 2011. Long after the tortured process that produced the final bill is forgotten, the statutory language and the U.S. Food and Drug Administration’s (FDA) implementation of it will remain. Though the bill often specifies timelines for the rulemaking process and while the agency has already begun working on the rules, the actual date that the implementing regulations will go into effect. Stay tuned to PMA for the latest information. The following are key components of the bill that will affect PMA members. The next step is that FDA will implement the new law with regulations, and this summary will give companies a sense of what is to come from FDA. Produce Standards. Within one year of enactment of the law, FDA must issue proposed regulations on produce standards. The science-based standards are to be issued for those types of fruits and vegetables (including specific mixes or categories) the agency determines need standards in order to minimize risk to human health. Before becoming effective one year after the close of the comment period on the proposed rules, the agency must conduct public hearings across the country and the rules must take into account environmental, organic, and possibly even regional differences. FDA must prioritize the implementation based on known risks, including the history of outbreaks. Food Safety Plans. Each food facility must have a written food safety plan that includes hazard analysis and preventive controls, a description of verification and recordkeeping, and procedures for monitoring, recall, and tracing. The plans, which are available to FDA during an inspection, must also address risks from intentional contaminations such as terrorism. A facility must update its plan every three years or when it makes a significant change in the facility. Traceability and Recordkeeping. After several studies and pilots (including a fruit and vegetable pilot), FDA shall establish a system that improves the capacity to effectively track and trace food. In addition, FDA must issue regulations requiring enhanced recordkeeping for what it determines and makes public to be “high-risk foods.” The system must be science-based and technologically neutral and have benefits that outweigh the burdens of the additional requirements. It is not required to contain the full pedigree of information or require product tracing to the case level. Grocery stores

buying directly from farms are exempted from recordkeeping requirements for those products, other than retaining for 180 days records documenting the source of the food. Access to Records. During an inspection, FDA (or its agent) may view and copy records bearing on whether the facility’s food is adulterated or misbranded. This includes food safety plans, testing results, corrective actions taken, and monitoring of supply chain. Registration. Under existing law, facilities that process, pack, or hold food (excluding farms, restaurants, and retail) must register with FDA. The new law does not change who must register, but it does require a registration renewal every two years, with no cost for registration. Laboratory Accreditation and Testing. Within two years, FDA shall issue regulations on food testing as well as on accrediting laboratories to standardize and increase the number of laboratories eligible to perform testing. Laboratories, U.S. and non-U.S., private and governmental, may receive accreditation, and FDA will establish a registry of accredited labs (though distribution of the list may restricted). The testing is to occur when otherwise required, including upon entry into the country, or when the Secretary determines...
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