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FDA Provides Update On FSMA Rules At NCC Annual Meeting

fda logoJennifer Erickson, regulatory counsel at the Food and Drug Administration, spoke to a gathering of cotton ginners at the National Cotton Council Annual Meeting in February. The presentation took place during the National Cotton Ginners’ Association Board of Directors and Annual Meeting. Erickson updated ginners on the current status of the FDA Food Safety Modernization Act as it relates to cotton gins.

For a little background, the FSMA’s Preventive Controls for Animal Food final rule was issued in September 2015.

One of the first problems was that the rule contained guidance that would affect cotton gins — Subparts C & E, which require a food safety plan and various other programs. The ginning industry did not agree this part of the rule applied, and we have been working on the issue since then.

FDA Has A Change Of Heart

After meeting with the industry in Alabama and touring a cotton gin, the FDA agreed their interpretation was in error and needed to be fixed.

In January 2018, the agency issued a policy regarding enforcement discretion for certain facilities, including cotton gins.

Under this policy, cotton gins are not subjected to the regulations related to preventative controls requirements or current good manufacturing practices. These are the portions of the rule with which the industry has been concerned.

Since then, two years have passed. While FDA has been working on the issue internally, some in the industry have been concerned since so much time has passed with no final solution. Enforcement discretion is great, but it is a temporary solution based on a guidance document that could be modified at any time.

Secondary Activities Farm Designation

With the above concerns in mind, it was good to see Erickson was willing to update our group on the status of FSMA related to the cotton ginning industry. She reemphasizes the enforcement discretion would remain in place until they were able to complete final fixes to the rule. She says FDA was reiterating its enforcement discretion policy during inspector training across the country.

FDA’s plan at this point is to develop a better farm definition to include operations like cotton gins, which handle raw agricultural commodities and meet the definition of a Secondary Activities Farm — except for the ownership of the facility. In other words, under the proposal outlined during the meeting, all cotton gins would be considered Secondary Activities Farms under the updated rule.

The counsel assured us FDA was committed to implementing a solution at the staff level and up the chain of command. The change would solve the issue cotton gins face with the rule, and according to Erickson, a little more patience with the FDA will result in a much better rule for our industry.

Our association, along with the National Cotton Council, the National Cotton Ginners’ Association and the other regional associations across the United States, will continue to monitor the issue closely. Hopefully, we will be able to give everyone an update in the near future.

J. Kelley Green, TCGA director of technical services, contributed this article. Contact him at kelley@tcga.org.

Significant Change Made To The Original Form I-9 Employment Eligibility Verification

The California Cotton Ginners and Growers Association says an updated Form I-9, Employment Eligibility Verification, from the U.S. Citizenship and Immigration Services, is now available. After months of waiting, a new I-9 form has been released.

California Cotton Growers and Ginning AssociationEmployers are still allowed to use the previous version of the I-9 until April 30. After that date, the new version must be used.

A significant change to the original Form I-9 includes an employer’s ability to designate an “authorized representative” to assist in completing the employer requirement on the form. The authorized representative is responsible for completing Section 2 of the I-9 that includes examining evidence of identity and employment authorization on behalf of the employer.

Additionally, clarification to the list of “acceptable documents” has been made, and a full list of those is available on the last page of the Form I-9.

Visit our website, https://ccgga.org/updated-i-9-forms-now-available/, for both the Form I-9 as well as the I-9 instructions for your review and use.

The California Cotton Ginners and Growers Association provided this information.