Industry groups – led by the NGFA – also worked to include language in the Senate bill that would expressly prevent FDA from imposing product-tracing requirements that would dismantle the feed and grain industries’ reliance on commingled handling, storage and manufacturing of ingredients and products obtained from multiple sources.
In the context of new mandatory recall authority, AFIA and NGFA worked to guarantee that administrative protections are incorporated in both bills to ensure new authority to FDA is not arbitrary, and that companies have legal recourse if they believe FDA is acting without sound scientific justification in ordering a recall. At the same time, it is important that records access is limited to those documents which pertain to a specific incident, and that proprietary information is protected.
Small business considerations
AFIA and NGFA worked to include recognition of new regulatory burdens on small entities/businesses as several small businesses, e.g. feed dealers, are included under the registration requirements of both bills. It’s important the compliance challenges for these small businesses are recognized, that assistance is given to small entities by FDA, and that compliance expectations in any new regime are pragmatic. AFIA and NGFA do not support exempting small entities. Both organizations believe further enhancements to food and feed safety enhancement should be a universal effort, in which all parts of the food/feed chain participate.
Fees and funding
The use of facility registration and other fees to fund new FDA authorities is problematic, and the industry opposes registration fees to fund federal food safety programs that provide overall benefit to the general public. Such fees are, in reality, de facto taxes, and such programs are rightly funded by the federal government, NGFA and AFIA believe.
Both associations are also concerned that new authority to FDA to charge fees for re-inspections, export certificates, the cost of recalls and voluntary import programs is too open-ended. These fees should be prescribed by a formula that prohibits FDA from setting fees as an income-generator as opposed to fees that cover the real costs of providing industry-specific services. This is how Congress created animal drug user fees, prescription drug user fees and medical device user fees, and there is no reason why such formulas cannot be included in the final law, Sellers said.
NGFA opposes several new authorities proposed in the House bill. For example, the House bill authorizes FDA to short-circuit the regulatory process by issuing regulations through guidance documents, without the requirement for public comment or economic impact analysis.
The House bill also authorizes FDA to suspend a facility’s registration — its license to operate — based on a belief that it “could” pose a danger to human or animal health and would dramatically increases civil penalties, even for unintentional or minor violations that do not pose a danger to human or animal health.
The industry is rightfully concerned over these potential new authorities and is fighting to improve the Food/Feed Safety bill before it is passed.
Fighting for a better bill
For several reasons, AFIA and the NGFA strongly believe the Senate version is a much better bill, and avoids many of the most problematic provisions found in the House bill.
Overall, H.R. 2749 and S. 510 include similar provisions; however, the House bill is far more prescriptive in how FDA should implement new programs, whereas the Senate bill gives FDA authority to create those programs but leaves development up to the agency.
While neither bill is near perfect, there are some improvements contained in the Senate version. H.R. 2749 would require food facilities to re-register and pay an annual registration fee, whereas S. 510 would require facilities to re-register biennially, but would not impose registration fees.
H.R. 2749 would require food importers and customs brokers to register with FDA, and would require food importers to pay an annual registration fee. S. 510 would not require importers or customs brokers to register, but it would require importers wishing to participate to pay fees sufficient to cover FDA’s administrative costs of operating the Voluntary Qualified Importer Program to expedite imports of regulated products..