The National Grain and Feed Association (NGFA) and the North American Export Grain Association (NAEGA) today said they are hopeful that the Food and Drug Administration (FDA) will make major changes to its proposed regulations implementing the bioterrorism-preparedness law passed by Congress in 2002.
FDA earlier this spring issued proposed regulations that will require, effective Dec. 12, that all U.S. and foreign facilities -
encompassing grain elevators, feed mills and processing plants - that manufacture, process, pack or "hold" food for human or animal consumption in the United States register with the agency. FDA proposed to apply the registration requirement to both stationary and "mobile" facilities. In a second set of regulations, FDA proposed that importers, starting on Dec. 12, provide prior notice concerning shipments of food, feed or feed ingredients destined for the United States. And in a third rulemaking, the agency proposed that food and feed facilities, as well as transporters, maintain records sufficient to identify the immediate previous domestic or foreign sources, as well as the immediate subsequent recipients, of such shipments.
FDA is scheduled to publish final regulations by Oct. 12.
Congress in the law itself exempted from the registration and recordkeeping requirements: farms, retail food stores, restaurants, fishing vessels (if the fish are not processed); and facilities already regulated by USDA under the meat or poultry inspection acts.
In three separate joint statements submitted to FDA, the NGFA and NAEGA said they believed that substantial sections of FDA's proposed rules exceed the requirements of the law and would not materially contribute to improvements in either the safety or security of the U.S. food supply.
The NGFA, established in 1896, consists of 1,000 member companies from all sectors of the grain, feed, processing and exporting business that operate about 5,000 facilities that handle more than two-thirds of all U.S. grains and oilseeds. NAEGA, established in 1912, is comprised of private and publicly owned companies and farmer-owned cooperatives involved in and providing services to the bulk grain and oilseed exporting industry. The NGFA and NAEGA are collocated and have a joint operating and services agreement, under which they coordinate government representation activities.
The following are several of the major concerns voiced by the NGFA and NAEGA on the three FDA proposals:
Registration of Food and Feed Facilities:
The NGFA and NAEGA commended FDA for developing a system whereby facilities could register electronically, as
well as by paper, for free. But the agency was encouraged to make the registration process less time-consuming for companies with multiple facilities, rather than requiring data entry by each facility individually.
The NGFA and NAEGA also urged FDA to redesign its registration form to more clearly specify which sections are optional (for instance, the listing of specific products handled and the name of the "responsible" individual at the facility), and to clarify that failure to update optional information is not subject to civil or criminal penalties.
The NGFA and NAEGA also termed "inappropriate" FDA's proposal to hold importers financially and criminally liable for the failure of foreign facilities to properly register with the agency. Under the proposed rules, imports from foreign facilities that fail to properly register would be denied entry into the United States, with the importer assessed charges for holding the product at an FDA-approved bonded warehouse until the foreign facility is registered.
The two associations also urged FDA to exempt from the registration requirement: 1) feed, pet food and farm supply stores that sell products directly to final consumers, and which therefore should qualify under the "retail store" exemption mandated by Congress; and 2) U.S. grain handling or feed facilities whose products are shipped only for export. FDA also was urged to make the exemption applying to farms size-neutral.
In other comments concerning FDA's proposed registration requirements, the NGFA and NAEGA urged FDA to: 1) allow more time than the proposed 30 days to update registration information; 2) clarify when a cancellation or update to registration is required, and simplify the cancellation process; and 3) to continue an aggressive education effort to inform regulated facilities,
particularly foreign establishments.
Prior Notice of Food Imports: The NGFA and NAEGA voiced major concerns over FDA's proposed regulations to require prior notice of food, feed and feed ingredient imports. The two associations cited what was termed the "excessive, burdensome and unworkable" information that FDA proposed to have importers collect, including the identity and location of the grower of the agricultural product, if known. FDA also proposed to require importers to identify the names of "intermediate destinations"; specific quantity of the shipment (which would prevent "topping off" a shipment without amending the prior notice); identifying the specific lot/FDA product code numbers; and listing the common, trade name and usual name of product. The NGFA and NAEGA warned that the prior notification requirements could be viewed by foreign countries as a non-tariff trade barrier, which could subject the United States to challenge before the World Trade Organization.
"FDA's final rules very likely will become the template for practices that could be adopted by foreign countries and applied with equal force and vigor against U.S. exports of bulk and processed agricultural commodities, feed and feed ingredients, meat products and other agricultural exports," the NGFA and NAEGA wrote.
The NGFA and NAEGA also urged the agency to develop a seamless interface with the existing electronic prior notification system being used by Bureau of Customs and Border Protection, rather than trying to create a new, duplicative system. FDA subsequently announced that it is in the process of working with Customs to develop such an integrated system.
The NGFA and NAEGA also urged FDA to change its proposed prior-notice regulations by: 1) reducing the time deadlines for providing prior notice, and making them more reflective of the mode of transport being used and more in-line with the four-hour advance notification requirement of the Customs Bureau. [FDA originally proposed that prior notice be made by noon of calendar day before imported food is scheduled to arrive at the port of entry]; 2) expand the authorization of parties allowed to submit or amend previously issued prior notices to include transporters, which are often in best position to provide complete, accurate information. [FDA proposed to restrict eligibility for issuing prior notice to the U.S. purchaser, importer or U.S. agent.]; and 3) Provide more opportunity to amend prior notices, such as for product identification and anticipated arrival time.
Recordkeeping/Access to Records: The NGFA and NAEGA also submitted extensive comments on FDA's proposed regulations that would require U.S. and foreign facilities that "manufacture, process, pack, distribute, receive, hold or import" food or feed into the United States to maintain records and make those records available to FDA if the agency receives a "credible threat of serious adverse health consequences or death" to humans or animals.
Most importantly, the NGFA and NAEGA urged FDA to clarify that facilities that receive, handle, manufacture or ship raw commodities, ingredients or finished products on a commingled basis are exempt from the requirement to identify specific sources of ingredients, unless the products are segregated or identity-preserved for commercial reasons. [FDA proposed that "reasonably available" information be retained to identify specific source of each ingredient used to make every lot of finished product, to link incoming ingredients with outgoing finished products.]
The associations also cautioned that attempting to impose recordkeeping requirements on foreign facilities could pose WTO trade challenges. Further, the NGFA and NAEGA recommended that FDA base its determination that a "credible threat" exists - the threshold that FDA must meet to gain access to records - on science-based criteria rather than "reasonable belief."
The two associations also urged that FDA: 1) grant additional time for providing access to records; 2) submit requests for records in writing to avoid potential confusion; and 3) prioritize its records request to the immediate location where FDA has "credible evidence" of a contamination incident. FDA also was encouraged to exempt from the law's penalty provisions, good-faith efforts to comply. [FDA proposed that records be provided within four hours if requested between 8 a.m. and 6 p.m. weekdays; and within eight hours on weekends and holidays, which could overwhelm the ability of companies to respond.]
Among other things, the NGFA and NAEGA also recommended that FDA: 1) include retail feed, farm supply and pet food stores under the exemption from maintaining records of final retail purchasers/customers that FDA proposes for retail facilities; 2) remove "redundant" recordkeeping required of facilities and transporters; and 3) clarify that recordkeeping requirements only apply when products/articles change possession/title between firms, and not to intra-company records.
NGFA members encompass all sectors of the industry, including country, terminal and export elevators; feed manufacturers; cash grain and feed merchants; end users of grain and grain products, including processors, flour millers, and livestock and poultry integrators; commodity futures brokers and commission merchants; and allied industries. The NGFA also consists of 36 affiliated state and regional grain and feed associations, as well as two international affiliated associations. The NGFA also has established strategic alliances with the Pet Food Institute and the Grain Elevator and Processing Society.
NAEGA member companies ship practically all of the bulk grains and oilseeds exported each year from the United States. The Association's mission is to promote and sustain the development of commercial export of grain and oilseed trade from the United States. NAEGA acts to accomplish this mission from its office in Washington D.C., and in markets throughout the world.