In 2017, the Texas Department of Agriculture (TDA) was given authority to implement the federal Food Safety Modernization Act’s (FSMA’s) new rule on Produce Safety in Texas. The belief was that TDA would work more cooperatively with Texas farmers than the federal Food & Drug Administration (FDA) was likely to.
TDA published its proposed rule just last month, and we quickly sent you an alert about the most blatant problem–mandatory registration for all farms. A closer reading shows that there are actually three provisions in which TDA’s proposed rule is even worse than FDA’s FSMA rule:
1) Every produce farm will have to submit an “annual survey” to TDA. The proposed rule doesn’t provide any specifics about what information will be required, but states that the agency will use this to determine whether or not the agency thinks that the farm has a “qualified exemption” from the requirements of the Produce Safety Rule.
This is effectively mandatory registration of all produce farms, which is not required under the federal rule. Under FSMA, a small, direct-marketing farm has a qualified exemption from the rule’s requirements, without having to register or seek approval by any agency.
2) If a farm fails to submit this paperwork within 60 days of the annual deadline each year, TDA will presume “that the farm is subject to all requirements of the Produce Safety Rule.”
In other words, a small farm that is exempt from FSMA, but that failed to file paperwork with the TDA for whatever reason, would face an inspection and enforcement action in which the burden of proof would lie with the farm rather than the agency. Note that the FDA estimates that complying with the requirements would cost a small farm almost $25,000 per year.
3) TDA is claiming authority to enter any farm at any time of the day or night, and to stop sales from that farm for an unspecified period of time, if there are “egregious conditions.” This term is not found in FSMA or in the FDA’s implementing regulations, and has a very broad, vague definition.
TDA is taking public comments on the proposed rule until January 31, and we need your help to push back and keep the agency in line with FSMA. If you already submitted a comment in response to our first alert in December, great! If not, please make time to take action now.
TAKE ACTION #1: Submit comments to TDA
First, submit a comment on the proposed rule:
- Via email: RuleComments@TexasAgriculture.gov
- By mail: Richard De Los Santos, Director of the Texas Office of Produce Safety, Texas Department of Agriculture, P.O. Box 12847, Austin, Texas, 78711
Please send a copy of your comments via email to Info@FarmAndRanchFreedom.org, so that we have a record of them.
A sample comment is below. Note that it includes several blanks, with possible ideas for comments in parentheses. This is because submitting an identical “form comment” will not have much effect. Please take a few minutes to tailor the comment based on your situation and thoughts. Even a very short comment that is personalized has a much greater impact!
TAKE ACTION #2: Donate to our Response Fund
With our history in helping to get the exemption for small farms under FSMA, FARFA is well-positioned to fight against this government overreach–but we need your help. We need to bring additional legal help onto our team and reach out to our allies, both in Texas and nationwide, since this is a national issue.
Can you help us with an extra-generous donation, so that we can take on this issue in addition to all the other work we have to tackle in 2019?
I urge the TDA to reconsider its proposed rule and:
- Make the “farm inventory survey” voluntary, without any penalty for small farms that do not submit it, and
- Make the right of entry and stop-sale provisions match the official federal regulatory standards, rather than including the overly broad and vague “egregious conditions” provisions.
I am a _ [produce farmer, local food consumer, diversified producer, chef …] .
It is not appropriate to require small farms to register with the agency because_ [too much hassle, government intrusiveness, not required under federal law …] .
At the very least, failure to register with the agency should be a simple administrative violation, not something that creates a presumption that the farm has to comply with the numerous, expensive requirements of the Produce Safety Rule.
The provisions for “egregious conditions” should also be taken out. The definition is very broad and potentially subjective, and is not an appropriate basis for the agency to come onto a farm with no notice and stop sales of perishable produce. The federal regulations have provisions that address entry onto farms and recalls, and those are sufficient.
[Add more comments of your own]
FARFA and 5 other ag groups have urged TDA to extend the comment period beyond January 31, but we do not know if the agency will do so. You can read our letter at https://farmandranchfreedom.org/request-for-tx-fsma-comment-extension/.
THE PROPOSED RULE:
You can read the proposed regulations here. Note that wherever the proposed rule mentions “21 C.F.R. §___,” the agency is essentially taking the extensive federal regulations and making them state law. For better or worse, the federal regulations are what they are at this point–the issue now is the additional requirements that TDA is adding.
The relevant portions of the proposed rule are copied below. TOPS refers to a new division of the TDA, the “Texas Office of Produce Safety.”
§11.20.Farm Inventory Survey.
A farm in Texas which grows covered produce is required to submit a Farm Inventory Survey to determine whether it is exempt, covered, or eligible for a qualified exemption from the requirements of the Produce Safety Rule.
TOPS shall conduct a pre-assessment review to determine whether a farm is covered by the Produce Safety Rule and/or eligible for a Qualified Exemption.
(1) A covered farm is eligible for a Qualified Exemption if it meets the requirements of 21 CFR §112.5.
(2) A covered farm which is eligible for a Qualified Exemption under 21 CFR §112.5, must establish and maintain adequate records demonstrating compliance with criteria necessary for qualified exemption as required by 21 CFR §112.7(b).
(3) A covered farm eligible for a Qualified Exemption is subject to the modified requirements set forth in 21 CFR §112.6, and this chapter.
§11.22.Verification of Eligibility.
(a) Qualified Exemption determinations for covered farms shall be calculated on a yearly basis, valid until their anniversary date, which is one (1) year from the date of issuance by TOPS. A covered farm shall be required to reaffirm eligibility for a Qualified Exemption status upon its anniversary date.
(b) TDA will provide notice of the required reaffirmation and renewal of a Qualified Exemption by sending a Qualified Exemption Verification Form to the farm’s last known address, as reflected in TDA’s records, at least 30 days prior to the anniversary date.
(c) Failure to return a Qualified Exemption Verification Form within 45 days after its anniversary date shall result in a required on-site visit by TOPS to reevaluate exemption, coverage, or eligibility for a qualified exemption. Failure to return a Qualified Exemption Verification Form within 60 days of the anniversary date shall result in the presumption by TOPS that the farm is subject to all requirements of the Produce Safety Rule and this chapter.
(d) At any time, TOPS reserves the right to schedule an on-site visit to verify whether a farm is exempt, covered, or eligible for a Qualified Exemption.
§11.40.Right of Entry
(a) Right of Entry. During normal business hours, TOPS may enter the premises of a covered or Qualified Exempt farm, and all locations or areas where there are activities, conditions, produce, and equipment on covered and qualified exempt farms, or at any other location where covered activities occur:
(1) to examine records; or
(2) to conduct inspections.
(b) TOPS may enter the premises of a covered and exempt/or Qualified Exempt farm, and all locations or areas where there are activities, conditions, produce, and equipment on covered and qualified exempt farms, or at any other location where covered activities occur, to respond to any emergency involving an egregious condition, as defined in §11.42 of this title (relating to a Stop Sale), at any time.
(a) A Stop Sale Order may be issued upon a finding of an egregious condition, which is a practice, condition or situation on a farm or in a covered location that is reasonably likely to lead to:
(1) serious adverse health consequences to, or death of, a human from the consumption or exposure to covered produce; or
(2) an imminent public health hazard if corrective action is not taken immediately.