July 24, 2015
TO: JPA Members
FROM: Patricia Faison
JPA Regulatory Update
House Passes the “Safe and Accurate Food Labeling Act of 2015”
JPA has been providing update regarding the “Safe and Accurate Food Labeling Act of 2015,” (H.R. 1599), which would create a federal standard for voluntary labeling of foods derived from genetically engineered (GE) materials and pre-empt states from enacting their own mandatory labeling laws. According to an article published by The Hill, available here, the House of Representatives voted 275-150 in favor of the legislation. At this time, similar legislation has not been introduced in the Senate and as such, Vermont can continue to move forward with implementation of its GE food labeling law.
GMA’s press release applauding the vote is available here.
JPA will continue to monitor and provide updates, as information becomes available.
FDA Publishes Proposed Rule and Draft Guidance Related to FSMA’s Accreditation of Third-Party Auditors Provisions
JPA has been providing updates regarding the Food and Drug Administration’s (FDA’s) efforts to implement the provisions of the FDA Food Safety Modernization Act (FSMA). According to a Constituent Update recently issued by the Agency, available here, a proposed rule and draft guidance related to the “Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications’’ (Accreditation of Third-Party Auditors) have been published.
As you may recall, in July 2013, the FDA issued a proposed rule regarding the accreditation of third-party auditors to provide for accreditation of third-party auditors and certification bodies to conduct food safety audits of foreign food entities, including registered foreign food facilities, and to issue food and facility certifications. Under this program, in which participation is voluntary, FDA will recognize accreditation bodies, which will in turn accredit third-party auditors to conduct food safety audits and issue certifications for foreign facilities and food under specified programs.
The FDA is required to establish a user fee program to assess fees for the work performed by the Agency to establish and administer the third-party accreditation program. The proposed rule published in today’s Federal Register (80 FR 43988) and available here, establishes user fees for participation in the third-party accreditation program. According to the Federal Register notice, the proposal includes the following: “(1) Who would be subject to a user fee; (2) how user fees would be computed; (3) how FDA would notify the public about annual fee rates; (4) how the user fee would be collected; and (5) what the consequences would be for not paying a user fee.”
According to the FDA, the user fee would apply to the following groups.
- Accreditation bodies submitting applications or renewal applications for recognition in the third-party accreditation program;
- Recognized accreditation bodies participating in the third-party accreditation program;
- Auditors/certification bodies submitting applications or renewal applications for direct accreditation; and
- Accredited auditors/certification bodies (whether accredited by recognized accreditation bodies or by FDA through direct accreditation)
- participating in the third-party accreditation program.
The FDA will assess application fees for the estimated average cost of the work the Agency performs in reviewing and evaluating applications. According to the Agency, the application fees will be charged to accreditation bodies applying for recognition, recognized accreditation bodies submitting renewal applications, auditors/certification bodies applying for direct accreditation and accredited auditors/certification bodies applying for renewal of direct accreditation. In addition, annual fees will be assessed for the estimated average cost of the work FDA performs to monitor performance to requirements for recognized accreditation bodies, auditors/certification bodies accredited by the FDA and auditors/certification bodies accredited by recognized accreditation bodies.
The FDA estimates the following user fees:
- The review of an application for recognition for an accreditation body would be $35,850 (includes FDA travel to the foreign facility).
- The renewal of an application by a recognized accreditation body would be $18,853 (includes FDA travel to the foreign facility).
- Auditors/certification bodies applying for direct accreditation would be subject to a fee of $35,850 (includes FDA travel to the foreign facility).
- Accredited auditors/certification bodies applying for renewal of direct accreditation would be assessed a fee of $26,930 (includes FDA travel to the foreign facility).
- The annual monitoring fee for recognized accreditation bodies would be $26,930.
- The annual monitoring fee for auditors/certification bodies accredited by the FDA would be approximately $1,585 to $1,878 depending on inflation.
- The annual monitoring fee for auditors/certification bodies accredited by recognized accreditation bodies would be approximately $1,982 to $2,250 depending on inflation.
The hourly rates used by the Agency to calculate the user fees would be adjusted yearly using an inflation adjustment factor.
Comments related to the proposed rule must be submitted to the FDA by October 7, 2015. JPA staff is in the process of compiling the list of topics in which the FDA is seeking. Additional details, including the opportunity to comment, will be provided in the near future. JPA’s FSMA Task Force will also be considering whether comments should be submitted to the Agency.
Draft Guidance: Model Accreditation Standards
According to the FDA, the Agency is “required to develop Model Accreditation Standards that recognized accreditation bodies shall use to qualify third-party auditors/certification bodies for accreditation, and in so doing, to look to existing standards for certification bodies…to avoid unnecessary duplication of efforts and costs.” The FDA considered several voluntary consensus standards for their relevance to the third-party accreditation program and was ultimately guided in developing the draft Model Accreditation Standards guidance document by the International Organization for Standardization (ISO)/International Electrotechnical Commission (IEC) ISO/IEC 17021: Conformity Assessment – Requirements for bodies providing audit and certification management systems (2011) (“ISO/IEC 17021:2011”).
The FDA notes the draft guidance, “Third-Party Auditor Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards,” available here, contains the Agency’s recommendations on third-party auditor/certification body qualifications, including recommendations based on provisions in the accreditation of third-party auditors/certification bodies proposed rule issued in July 2013. The draft guidance includes the following topics:
- Authority and responsibility
- Capacity and competence
- Conflicts of interest
- Quality Assurance
- Regulatory Audit Reports
Miscellaneous: Publicly accessible information and directory of certified clients; Certification documents
The FDA has established October 7, 2015 as the deadline to submit comments. Today's Federal Register notice is available here. Additional details, including the opportunity to comment will be provided in the near future.
As always, please contact me with questions or comments.
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