FSMA Comments Sign-On Letter

    Sign-on to a joint organizational letter to the FDA with comments on the Tester-Hagan exemption

    Dear friends and allies, Over 100 organizations worked together to convince Congress to include the Tester-Hagan exemption in the Food Safety Modernization Act (FSMA). This provision exempts small-scale, direct-marketing farmers and food businesses from some of the new federal regulations. It is vital to the continued survival and growth of the local foods movement. FDA proposed rules to implement FSMA earlier this year, and the comment period HAS BEEN EXTENDED to Friday, November 22. Although the exemption is written into the statute, there are several problems with FDA’s proposed implementation of it. Below is a letter to FDA discussing the main issues and recommending changes. Will you join us in trying to ensure that the Tester-Hagan exemption accomplishes its goals and protects our local food producers? The deadline to sign on to this letter HAS BEEN EXTENDED to 5 pm Eastern on Thursday, November 21. We will submit the letter with all the signatories as a formal comment on the proposed rulemaking the following day. The letter is at the end of this page, as is a short form to add your organization’s name. For more information, contact Judith McGeary, Farm and Ranch Freedom Alliance, at 254-697-2661 or Judith@FarmAndRanchFreedom.org ***We encourage everyone to submit individual comments about their concerns with the proposed rules, in addition to signing on to this letter.*** More information about problems with FDA’s proposed rules, including step-by-step instructions on how to submit comments directly to FDA, is available at http://farmandranchfreedom.org/category/local-foods/federal-food-safety Thank you, Judith McGeary Executive Director Farm and Ranch Freedom Alliance www.farmandranchfreedom.org Email: Judith@FarmAndRanchFreedom.org Office Phone: 254-697-2661 PRIVACY NOTE: Contact information provided on this page will only be used to list your organization as a signer on the letter to the FDA and to provide occasional updates on the FDA's proposed rules under FSMA. The list generated will not be shared or otherwise used by FARFA or any other organizations.

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    Full text of comments to FDA on Tester-Hagan exemption:

    Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 Re: Preventive Controls Rule: FDA-2011-N-0920 and RIN 0910-AG36 Produce Standards Rule: FDA-2011-N-0921, and RIN 0910-AG35 Dear FDA: The undersigned organizations and food businesses jointly submit these comments on the Tester-Hagan provisions, also referred to as the qualified exemptions, in the Preventive Controls and Produce Standards Rules. I. Background and Summary The Food Safety Modernization Act exempts small-scale, direct-marketing farmers and facilities from the new standards on growing and harvesting produce and the hazard analysis and risk-based preventative controls requirements. Since the provisions for the Tester-Hagan qualified exemption are largely the same in both rules, we will refer to farmers and/or facilities jointly as “producers” unless the comment refers to only one in particular. The Tester-Hagan provision is vital for protecting vulnerable, small-scale producers that are providing safe, healthy food for their local communities. With the rapidly growing interest in locally produced food, this protection is in the best interest of consumers as well as the farmers and food businesses. There are three areas of concern with FDA’s proposed provisions implementing the Tester-Hagan provision: (1) who is covered; (2) what they are exempt from; and (3) the procedures for revoking the exemption. Each of these issues is explained below. II. Who is covered: the test for qualifying for the Tester-Hagan exemption should be based on sales of food that is regulated under FSMA Under the proposed regulations, a producer is eligible for a “qualified exemption” if: • During the previous three-year period, the average annual monetary value of the food sold directly to individual consumers or to restaurants and retailers in the same State or within 275 miles exceeded the average annual monetary value of the food sold to all other buyers during that period; and • The average annual monetary value of all food sold during the previous three-year period was less than $500,000, adjusted for inflation with 2011 as the baseline year. The FDA’s definition of food includes all food sold by the farmer or food processor, not just the food that is subject to the agency’s jurisdiction or regulated under FSMA. As a result, sales of meat and grains will all be counted toward the $500,000 gross sales limit. Therefore, for example, a grass-fed beef producer with a small orchard who sells $600,000 in beef and $10,000 of fruit will be subject to all of the new FSMA requirements for growing and harvesting produce, even though the FDA and FSMA do not regulate beef. This interpretation does not fulfill the intent of the Tester-Hagan provision to protect small-scale, direct-marketing producers of fruits, vegetables, and processed foods from the extensive new federal regulations. Instead, it effectively forces grain and livestock farmers to avoid any diversification, harming farmers financially and discouraging environmentally responsible land use. From a food safety standpoint, it does not make sense to treat the small-scale production of produce the same as large-scale production, simply because the same person is producing other types of food as well. We urge the FDA to amend the proposed regulations so that the gross sales test is measured by the sales of food subject to regulations under FSMA. III. What the exemption covers: qualified facilities should be exempt from both the HARPC and the CGMP requirements The qualified exemption provided in the Preventive Controls proposed rule is only from Subpart C, the Hazard Analysis and Risk-Based Preventive Controls (HARPC) requirement. FDA proposes that these small, direct-marking facilities should still be subject to Subpart B, Current Good Manufacturing Practices. The new CGMPs cover everything from personnel cleanliness, education and training, the grounds and area around the facility, plant construction and design, operational aspects, sanitary facilities and controls, equipment and utensils, processes and controls, raw materials and ingredients, and warehousing and distribution. These types of process-based regulations typically favor large operations and are not often feasible or cost-effective for small-scale operations. To our knowledge, every state already regulates food handlers, processors, and manufacturers. Many local governments have additional regulations. As with the HARPC requirement, we believe that the state and local regulation is sufficient for small-scale, direct-marketing operations. We urge the FDA to use its discretion under the law to exempt qualified facilities from Subchapter B as well as Subchapter C. IV. The procedure: Producers with qualified exemptions should be provided with due process if the FDA considers revoking their exemption In addressing the issue of revoking a producer’s exemption, the FDA takes an approach that the situation is urgent, and therefore establishes extremely short and unreasonable deadlines. The FDA’s stated rationale is that “either of the two circumstances that could result in our determination that an exemption should be withdrawn … warrant prompt compliance with the rule in the interest of public health.” 78 Fed. Reg. at 3613. Yet the FDA is empowered to revoke the exemption absent any immediate threat to public health. The FDA may revoke the exemption if a foodborne illness outbreak is linked to the farm, whether or not the farm appears to be the cause. Moreover, the FDA may revoke the exemption if it determines it is necessary to “protect the public health and prevent or mitigate a foodborne illness outbreak based on conduct or conditions associated” with the farm. These are not urgent situations. If there is truly an immediate risk to the public health, the FDA has other options to address the problem. The agency has multiple enforcement tools at its disposal, such as: • Seeking an injunction or temporary restraining order under 21 U.S.C. 332; • Seizing the food at issue under 21 U.S.C. §334(a); • Administrative detention of the food under 21 U.S.C. §334(h) We therefore urge the agency to provide appropriate due process before revoking any producer’s exemption. Specific items are outlined below. A. The notice of revocation: The agency proposed rule provides that it will give only a general statement of the basis for the revocation in its initial letter to the producer. The result is that a producer will be left guessing as to what the problem is and will have to mount a defense against an unknown set of allegations. The agency’s notice of intent to revoke a producer’s exemption should include a specific statement of the reasons, so that the producer can respond to the specific issues of concern. B. Evidentiary standards: The proposed rule provides no standards for what the FDA must show in order to begin an investigation of a producer or to revoke a producer’s exemption. The FDA should be required to have probable cause before initiating an investigation of an exempt farmer or food facility, and to present clear and convincing evidence for revoking the exemption. C. The response and hearing process: Under the proposed rules, a producer that wishes to contest the withdrawal of its exemption has only 10 calendar days to submit a written appeal that includes all of the facts and supporting documentation. While it would be appropriate to require the notice of appeal to be filed promptly, it is completely unrealistic to expect a producer to be able to marshal all of the arguments and relevant documents on what could be a multitude of issues raised by FDA. In addition, under the proposed rules, the producer is not entitled to a hearing. After the decision is made, with or without a hearing, the FDA’s proposed regulations also fail to provide standard post-decision procedural protections, such as motion for reconsideration and a motion for stay. We urge the FDA to amend the proposed regulations to provide producers with at least 90 days to compile the information and documents that support their continued qualified exemption. In addition, producers should have a right to hearing before their exemption is revoked and be provided the standard post-decision procedural protections. D. Time for compliance: Under the proposed regulations, a producer has only 60 days from the date of the original letter to come into compliance with all of the regulations. In comparison, large-scale farms have two years and large-scale facilities have one year to come into compliance with the proposed regulations initially. Small-scale producers are given an additional year, while very small scale producers are given two extra years to come into compliance, if they are not exempted under Tester-Hagan. It is wholly unrealistic to expect a small or very small producer (the only ones that would qualify for the Tester-Hagan provision) to comply with all of the requirements within sixty days when it has been functioning under the qualified exemption. In effect, a small producer whose exemption is revoked will almost certainly go out of business. The FDA’s proposed regulations have significant implications not only for existing producers, but also for anyone who is considering starting a farm or food business. What rational person would start a new business knowing the he or she could be forced to comply with complicated, expensive regulations with only 60 days notice? At a time when multiple government programs seek to encourage new and beginning farmers, the FDA’s proposed regulations will have precisely the opposite effect. We urge the FDA to amend the proposed regulations to provide that, if the exemption is revoked, the producer shall have two years from the time of the final determination to comply with all of the FSMA regulations. Alternatively, FDA could consider provisions that would require compliance with only those portions of the FSMA regulations that formed the basis for the revocation. E. Options for reinstating the exemption or otherwise modifying the requirements: The FDA should provide for farms and food facilities to be able to address the specific issue(s) of concern and either maintain or requalify for the exemption. V. Documentation: The FDA specifically sought comments on the issue of whether farmers should have to comply with record keeping requirements in order to prove that they qualify under the Tester-Hagan exemption. The provisions governing farms in the Tester-Hagan exemption make no mention whatsoever of submitting documentation to FDA. See Sec. 419(f). In contrast, FSMA specifically requires that a “qualified facility” – i.e. a facility that qualifies for the Tester-Hagan exemption – submit documentation to the FDA that demonstrates specific things. See Sec. 418(l)(2). The difference in the statutory language between the two sections is significant. Congress expressed its intention to required facilities that fell within the Tester-Hagan exemption to submit documentation. By omitting any such requirement for farms that fall within the Tester-Hagan exemption, Congress implicitly expressed its intention that such farms should not have to comply with similar requirements. See Sosa v. Alvarez–Machain, 542 U.S. 692, 711, n. 9, 124 S.Ct. 2739, 159 L.Ed.2d 718 (2004) (“When the legislature uses certain language in one part of the statute and different language in another, the court assumes different meanings were intended.”). The agency should not require that a farm that is exempted under the Tester-Hagan amendment comply with the new record-keeping requirements of the proposed rules, nor develop and maintain any documents outside the farm’s regular course of business. CONCLUSION The undersigned organizations and food businesses respectfully urge FDA to amend the proposed regulations as outlined above. For more information, contact Judith McGeary, Esq. Farm and Ranch Freedom Alliance Judith@FarmAndRanchFreedom.org 254-697-2661 (o) or 512-484-8821 (cell)