NCC Comments on FDA Animal Feed Rule Guidance
The NCC and the National Cotton Ginners Association, along with eight other state and regional gin associations, filed comments with the FDA on their guidance titled, “Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities.”
February 21, 2017
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852.
RE: Docket ID: FDA-2016-D-2373
The National Cotton Council (NCC) and the National Cotton Ginners’ Association (NCGA) offer these comments in response to the Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities. The NCC is the central organization of the United States cotton industry. Its members include producers, ginners, cottonseed processors and merchandisers, merchants, cooperatives, warehouses, and textile manufacturers. Much of the industry is concentrated in 17 cotton-producing states, stretching from Virginia to California. The annual business revenue generated by cotton and its products in the U.S. economy is greater than $75 billion. The NCGA is the umbrella organization representing the eight state and regional cotton ginner associations. These ginning associations represent 600 individual cotton ginning operations throughout the 17 cotton-producing states.
As background, in the September 2015 FDA-FSMA Preventive Controls for Animal Food Rule, the preamble excluded all cotton gins from the Current Good Manufacturing Practices (CGMP) but included gins that are not considered farm-owned under the Rule’s Subpart C – Hazard Analysis and Risk-Based Preventative Controls and Subpart E – Supply Chain Program. The NCC and the NCGA met with FDA in March of 2016 to voice their concerns that the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals final rule (80 FR 56170; September 17, 2015) included some gins that would not be considered farm-owned. The ownership structure of a cotton gin should have no bearing on whether gins are included under any section of this rule. Furthermore, the U.S. cotton ginning industry believes that the FDA’s misunderstanding of cotton ginning and the resulting unnecessary and costly regulatory burden is without merit and will do nothing to ensure food safety.
Cotton gins do not convert any Raw Agricultural Commodity (RAC) into a processed food and do not perform any activity that would not fit within either the harvesting activity classification or the holding activity classification, as discussed within the definition of harvesting found in the final animal feed rule (80 FR 56170).
Cotton gins simply separate the seed cotton (a perishable RAC) into three products – seed; fiber; and leaves, sticks and stems. Removing cotton fiber is essentially breaking (or otherwise separating) the cotton fiber (non-food) away from the edible portion (i.e., cottonseed) of the RAC from the crop plant -- it could be compared to hulling or threshing. It could also fall into the category of cleaning seeds that are the harvested crop, including removal of leaves, stems, and husks. These cleaning activities are essentially the same as the screening of grain, which is included in the rule as a holding activity that does not change the RAC into a processed food.
Once the cotton fiber is removed from the seed, the seed is stored in a flat storage building or overhead hopper, which is a simple holding activity. After the fiber is separated from the seed, cotton gins are solely engaged in the storage of raw agricultural commodities from an FDA, or food perspective.
Comparing the corn harvesting process to the cotton harvesting process: The combine operates in the corn field, removing the husk from the corn and cob, then separating the corn kernels from the cob. The corn kernels are then stored in a grain elevator for shipment downstream.
In a cotton gin, the harvested seed cotton is moved to the cotton gin (to continue the harvesting process), where the seed is separated from the fiber and the sticks, stems and dirt. The seed is then stored at the cotton gin for shipment from the facility. The risk of any adulteration having taken place in the cottonseed chain is absolutely no higher than the risk of adulteration in the corn chain – the two processes are very similar from a food risk perspective.
- Farmer and Non-Farmer owned cotton gins are identical processes
In the final animal feed rule, there is a long discussion of farmer owned versus non-farmer owned facilities in the packing industry. This argument is not applicable to the cotton ginning industry, as the activities in a cotton gin whether farmer or non-farmer owned can all be classified within the harvesting or holding categories. This would not subject cotton ginning facilities to the rule’s related Subparts (B, C, or E) by definition. For this reason, the ownership issue is not germane to the conversation.
In the draft guidance, the ownership issue is especially critical in the packing and packaging services, but cotton gins do not perform any packing or packaging activities of food or feeds. So, while we agree that ownership may affect whether the cotton gin is subject to the registration requirements for the rule, we do not believe that a gin should be subject to Subparts (B, C, or E) of the rule, regardless of ownership.
- Treating Cottonseed Differently from Grain is Not a Risk-Based Distinction
The issue at hand is whether cotton ginning should be subject to Subparts C and E, if the gin is required to register. FDA has already agreed that cotton gins are not subject to Subpart B.
Practically speaking, if corn or milo from a grain elevator and cottonseed from a cotton gin are being purchased as food/feed ingredients, the health risk of these products is identical between the farm and the point of purchase for the customer (either a grain elevator or a cotton gin).
From a food perspective, a cotton gin and a grain elevator are very similar, and should have been treated the same in Response 123 in the final animal feed rule. A technical correction to this response could be made without further rulemaking, as FDA has previously done on other similar corrections.
The cotton industry appreciates this opportunity to comment on FDA’s Guidance Document. We look forward to working with FDA to address this important issue in a timely manner. Please contact us with any questions or for further clarification.
National Cotton Council
National Cotton Ginners’ Association
Arizona Cotton Ginners Association
California Cotton Ginners & Growers Association
Kansas Cotton Association - Ginner Committee
New Mexico Cotton Ginners Association
Oklahoma Cotton Ginners Association
Southeastern Cotton Ginners Association
Southern Cotton Ginners Association
Texas Cotton Ginners Association