Biogenesis Analytical Blog

Biogenesis Analytical Blog

FDA to Hold Two Additional Public Meetings on Major FSMA Proposed Rules

by Nancy McDonald on 08/22/14

The U.S. Food and Drug Administration (FDA) is announcing two additional public meetings on the Food Safety Modernization Act (FSMA) Proposed Rules on Foreign Supplier Verification Programs and the Accreditation of Third-Party Auditors/Certification Bodies. These meetings are the second and third in a series of meetings announced in the August 16, 2013 Federal Register Notice and on FDA’s FSMA website. View meeting information, including details on how to register, on FDA’s website.

FDA Update August 16, 2013

by Nancy McDonald on 08/22/14

The U.S. Food and Drug Administration (FDA) is announcing its intent to prepare an Environmental Impact Statement (EIS) that will evaluate the potential environmental effects of the proposed rule, “Standards for Growing, Harvesting, Packing and Holding of Produce for Human Consumption.” FDA is also announcing the beginning of a “scoping process,” which is designed to determine relevant issues that will influence the scope of the environmental analysis. Comments are due by November 15, 2013, to coincide with the closing of the recently extended comment period for the proposed produce safety rule.

FDA is conducting the EIS because it has received information through comments and its own analysis that an environmental analysis is needed. The agency is already assessing the issues that may give rise to significant impacts from the standpoint of the environment and the practicality of the rules and alternative ways to achieve the food safety goal. Because FDA is paralleling its own assessment of the issues with the EIS process, the Agency doesn’t anticipate that the EIS will delay final rule deliberations but will help by generating additional data and analysis and providing opportunity for stakeholder engagement.

FDA will carry out the EIS through a public process and actively engage various stakeholders, including other Federal agencies, State agencies and Tribal leaders.

Submit comments electronically (starting August 19, 2013) on, using the docket number FDA-2011-N-0921.

Comment Period Extended

by Nancy McDonald on 08/22/14

FDA is extending the comment periods on the proposed rules for Preventive Controls for Human Food and Standards for Produce Safety for 60 days until November 15, 2013. This is the second and final extension of the comment period for these two rules.  Read more on the comment period extension.

New Fees Under the FDA Food Safety Modernization Act

by Nancy McDonald on 08/22/14

On August 2, 2013, FDA will announce in a Federal Register notice the fiscal year FY 2014 fee schedule for certain domestic and foreign facility reinspections, importer reinspections, and failure to comply with recall orders.

There is no fee for an initial FDA inspection. FSMA authorizes FDA to assess and collect fees related to certain domestic food facility, foreign food facility, and importer reinspections. The fee for reinspection is to cover reinspection-related costs when an initial inspection has identified certain food safety problems. See the Assessment of Reinspection and Recall Fees by the FDA for more information.

FDA has authority to assess and collect fees for food recall activities associated with a recall order when a domestic food facility or importer does not comply with such order.

There are also fees that can be collected for administrative costs of the voluntary qualified importer program, for costs associated with issuing food export certifications, and for costs to establish and administer the third-party accreditation program.

The rates are as follows: $237 an hour if no foreign travel is required and $302 an hour if foreign travel is required. The fees are effective October 1, 2013 through September 30, 2014.


by Nancy McDonald on 08/22/14

FDA Issues Two Proposed Rules under FSMA to Strengthen the Oversight of Imported Foods

July 26, 2013

Today, FDA issued two proposed rules under the Food Safety Modernization Act (FSMA) aimed at strengthening assurances that imported food meets the same safety standards as food produced domestically. These new measures respond to the challenges of food safety in today’s global food system, in which imported food comes into the U.S. from about 150 different countries and accounts for about 15 percent of the U.S. food supply. They are part of the effort mandated by Congress to modernize the food safety system and focus on preventing food safety problems, rather than relying primarily on responding to problems after they have occurred.

The two proposed rules work together with the standards proposed in January 2013 for produce safety and preventive controls in facilities that produce food for humans. The two proposed rules publish in the Federal Register on July 29, 2013. Comments on the two new proposed rules on the safety of imported food are due by 120 days from the publication date.  

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