VI Regulatory Update

VI Regulatory Update

TO: All VI Members
FROM: Patricia Faison

VI Regulatory Update
(1) FDA Seeks $4.7 Billion in FY 2014 Budget
(2) Legislation Introduced to Reform Renewable Fuel Standard
(3) BPA Listed Under California’s Proposition 65
(4) FDA Publishes Results of Food Defense Vulnerability Assessments

FDA Seeks $4.7 Billion in FY 2014 Budget

According to a recent press release issued by the Food and Drug Administration (FDA), the Agency is requesting a budget of $4.7 billion as part of President Obama’s fiscal year (FY) 2014 budget, which covers the period of October 1, 2013 to September 30, 2014.  The release notes that industry user fees would fund 94 percent of the proposed increase, which includes a food facility registration and inspection fee and a fee to be paid by food importers to improve the safety of the food supply.  The FDA is also proposing new user fees to support its cosmetic and food contact substance notification programs.

Additional details regarding the budget request for the Department of Health and Human Services (HHS), which includes the FDA, are provided in the HHS document, “Fiscal Year 2014 Budget in Brief,” available here.

Legislation Introduced to Reform Renewable Fuel Standard

It was previously agreed that VI would monitor information related to food versus fuel and the impact on ethanol.  As such, we wanted to share the following for informational purposes only.

VI members were previously advised of food industry’s efforts to request that the Environmental Protection Agency (EPA) grant a waiver of the Renewable Fuel Standard (RFS), which requires that 36 billion gallons of renewable fuels (including corn-based ethanol) be allocated by 2022.  In November 2012, VI members were advised that the EPA had denied the RFS waiver request.  (Additional details can be accessed via the VI Member Communications Archive located on the Members Only section of the VI website:

According to a recent press release issued by Representative Bob Goodlatte (R-VA), two bills have been introduced in Congress to address concerns related to the Renewable Fuel Standard – the “Renewable Fuel Standard (RFS) Elimination Act” and the “Renewable Fuel Standard (RFS) Reform Act.”  The RFS Elimination Act (H.R. 1461) would repeal the RFS.  The RFS Reform Act (H.R. 1462) available here, would, in part, limit the amount of ethanol that can be blended into conventional gasoline at 10 percent, and eliminate the corn-based ethanol requirements.  The bill has bipartisan support and other cosponsors include Congressman Steve Wolmak (R-AR), Jim Costa (D-CA), and Peter Welch (D-VT).   Both bills have been referred to the House Energy and Commerce Committee.

On April 10, 2013, the American Frozen Food Institute (AFFI) released a statement of support for the RFS Reform Act, available here.  A number of food industry groups are listed in the statement also supporting introduction of the legislation.  Additional details regarding both bills can be accessed via The Library of Congress Thomas website, available here.  Use the “Search” feature to access the legislation by bill number.

BPA Listed Under California’s Proposition 65

VI staff has been providing periodic updates regarding Bisphenol A (BPA), a substance used in the manufacture of some plastics used for food and beverage containers.  Some concerns have been raised due to possible health risks associated with this substance.  (Additional details are available via the VI Communications Archive.)

VI members were previously notified that the California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) published a Notice of Intent to list BPA under Proposition 65 as a chemical known to cause reproductive toxicity.  The Notice of Intent informs the public that data is available citing BPA as causing reproductive toxicity and OEHHA’s determination that BPA meets the criteria for listing under Proposition 65.  OEHHA also proposed to adopt a Maximum Allowable Dose Level (MADL) of 290 micrograms per day for exposures to BPA.

According to an announcement recently posted by OEHHA, the Agency has added BPA to the Proposition 65 list of chemicals.  OEHHA has not adopted the proposed MADL of 290 micrograms per day as the Agency is reviewing comments on the MADL and will adopt a final MADL in a separate communication.

VI will continue to monitor and provide updates, as information becomes available.

FDA Publishes Results of Food Defense Vulnerability Assessments

VI has previously advised members of the FDA’s CARVER + Shock Vulnerability Assessment method, a prioritization tool that has been adapted for use in the food industry and can be used to assess the vulnerabilities within a system to an attack.  The Food and Drug Administration (FDA) and the U.S. Department of Agriculture’s Food Safety and Inspection Service have used this methodology to assess vulnerabilities of the whole farm-to-table supply chains of various food commodities.

FDA recently published a report, “Analysis of Results for FDA Food Defense Vulnerability Assessments and Identification of Activity Types,” which describes the results of FDA analysis of vulnerability assessments (VA) to determine if a potential “threshold” score for the implementation of mitigation strategies could be identified.  FDA was required to conduct the analysis and compile the report as required by FSMA.  FDA notes it has conducted VAs on more than 50 products or processes in the last several years, which has led to the identification of processing steps of greatest concern, and potential mitigation strategies to reduce vulnerabilities.  For the report, FDA reviewed the Criticality, Accessibility, and Vulnerability (CAV) scores from 25 vulnerability assessments to determine a potential threshold score for the implementation of food defense mitigation strategies.  Other CARVER + Shock scoring components (Recuperability, Effect, Recognizability, and Shock) were not included in its analysis.

Using the CAV scores to sort the data, FDA found that there were certain processing steps that repeatedly had high CAV scores.  FDA determined, however, that there is no equivalence between a score value of a processing step in one industry to the same score value for another processing step in a different industry because CARVER+Shock is a relative ranking tool.

FDA then reevaluated the data to determine what common attributes or activities occurred between processing steps, finding that processing steps could be grouped according to the type of activity occurring at a particular point in an operation.  FDA identified the following key activities types:

  • “Coating/Mixing/Grinding/Rework
  • Ingredient Staging/Prep/Addition
  • Liquid Receiving/Loading
  • Liquid Storage/Hold/Surge Tanks”

Detailed descriptions of the activity types are contained in Appendix A, “Activity Type Descriptions.”

FDA concludes, “By identifying and defining key activity types, a CAV score is no longer needed as a threshold.”  The activity types and their descriptions can be publicly disseminated, industry can objectively map processing steps into activity types, and any mitigation strategies associated with those activity types could be audited.  Additionally, FDA notes that tools can be developed by the Agency to assist food producers in identifying activities that should be conducted at a particular processing step and selecting mitigation strategies particular to their production process.

Please do not hesitate to contact Headquarters with questions or comments.

Patricia Faison
(404) 252 – 3663
[email protected]