Appropriations Bill to Cut FDA Funds, Brazil Cotton Payments Reported
On June 3, 2011, the fiscal year 2012 USDA and FDA1 Appropriations bill was introduced in the House after being reported by the House Appropriations Committee. The bill would cut FDA appropriations, project additional funding from user fees, and prohibit funding of payments to Brazil to settle a WTO cotton dispute. In its report, the Appropriations Committee also encourages FDA to establish a highly compliant importer pilot.
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Highlights from Bill and Committee’s Report
The following are highlights of the trade-related provisions in the text of the bill (H.R. 2112, as introduced) and the Committee’s report (H. Rept. 112-100)2.
FDA importer pilot sought. The Committee strongly encourages the Food and Drug Administration to establish a pilot project to expedite low risk imports for highly compliant importers, and to report to the committee on this endeavor by December 1, 2011.
The Committee states that such a project could be modeled on the Customs and Border Protection (CBP) Customs-Trade Partnership Against Terrorism (C-TPAT) and Importer Self-Assessment (ISA) programs..
(The Appropriations Committee also recently directed CBP to continue its work with other agencies, such as the FDA and the Consumer Product Safety Commission (CPSC), to provide guidelines on what constitutes low-risk shippers and shipments, which could include the concept of a certified importer program. See ITT’s Online Archives or 06/01/11 news, 11060116, for BP summary of the FY 2012 DHS Appropriations bill.)
FDA funding would decrease, but more user fees. H.R. 2112 would fund FDA salaries and expenses at $2.2 billion, $567 million (21%) below the President’s budget request and $284 million (12%) below what was appropriated in FY 2011.
According to H.R. 2112 and the Committee’s report, this decrease is projected to be more than offset by expected receipts from various user fees, including those established by the Food Safety Modernization Act (FSMA).
Brazil cotton settlement would not be funded. H.R. 2112 contains provisions which would prohibit funding from being used to provide payments to the Brazil Cotton Institute in settlement of a World Trade Organization dispute. (See ITT’s Online Archives or 08/02/10 news, 10080247, for BP summary of CRS summary of the U.S.-Brazil WTO cotton dispute.)
FSIS HQ and district staffing decisions. H.R. 2112 would provide $34 million less than what was appropriated in FY 2011 to the U.S. Department of Agriculture's (USDA's) Food Safety Inspection Service. The Committee states that while this decreased funding level may force FSIS to make some choices about the staffing levels that are currently maintained at district and headquarters offices, it ensures that inspection and sampling activities will be carried out uninterrupted.
Country of origin labeling would receive less funding. H.R. 2112 would reduce, by $1.1 million, funding for the Country of Origin Labeling Program as it relates to the completion of a data management system in 2011.
APHIS animal disease traceability/national ID system. The Committee directs the Animal and Plant Health Inspection Service (APHIS) to continue funding the new traceability system with funding in the base budget.
FDA rulemakings sought. The Committee instructs the FDA to issue:
- Sunscreen - a final rule on over-the-counter sunscreens that would require UVB and UVA testing and labeling before December 31, 2011.
- Gluten-free labeling - a final rule to define and permit the use of the term “gluten-free” on food labels before December 31, 2011.
- Children’s OTC cough, cold products - a proposed rule revising the monograph regulating the labeling of OTC cough and cold products for children (based on scientific evidence for safety and efficacy in pediatric populations, etc.).
Medical device classification of tanning beds. The Committee encourages the FDA to act in a timely fashion to finalize its review of the medical device classification of tanning beds and make formal recommendations regarding the classification.
Funding for certain meat, poultry activities would be prohibited. H.R. 2112 would prohibit funding for Federal Meat Inspection Act Section 410 panel activities, and Poultry Products Inspection Act Section 30 panel activities.
1FY 2012 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations bill
2Although the Appropriations Committee’s report does not have statutory force; departments and agencies are not legally bound by their declarations. It does, however, explain congressional intent and frequently have effect because departments and agencies must justify their budget requests annually to the Appropriations Committees.
H.R. 2112 available here
H. Rept. 112-101 available here