FARFA’s comments to TDA on FSMA implementation

On July 29, 2019, FARFA sent the following comments to the Texas Department of Agriculture in response to the TDA’s proposed implementation of the federal Food Safety Modernization Act rules relating to produce growers.



January 29, 2019

RE:      Comments on Texas Department of Agriculture’s proposed Food Safety Modernization Act (FSMA) Produce Safety Administrative Rule

The Farm and Ranch Freedom Alliance (FARFA) submits these comments on the Texas Department of Agriculture’s proposed “Food Safety Modernization Act (FSMA) Produce Safety Administrative Rule,” published December 14, 2018.

FARFA is a grassroots organization that advocates for common-sense policies for local, diversified agriculture.  FARFA worked extensively with organizations across the country and members of Congress to incorporate provisions in the federal Food Safety Modernization Act (FSMA) that address the concerns of small-scale food producers and the consumers who wish to purchase food from them.  In particular, the federal statute included exemptions for small farms and food producers who sell primarily to consumers and local restaurants and retailers.  These statutory exemptions are reflected in the Food and Drug Administration’s (FDA’s) FSMA rules.

Without these exemptions, thousands of small farmers would, quite literally, be put out of business. The FDA’s own estimate is that it would cost a small farm close to $25,000 per year to comply with the substance of the Produce Safety Rule.  Even for larger farms, many of the provisions of the Produce Safety Rule are problematic.  While FARFA has concerns about the substance of the federal rule, we recognize that TDA has very limited power to differ from the federal standard.

FARFA’s comments will thus focus on those provisions in the proposed rule that differ from the federal rule.

I. The TDA lacks statutory authority to require farm registration.

In early 2018, TDA staff stated at public meetings that the agency intended to require every produce farm to register with the agency.  FARFA sent a letter objecting to this plan on March 19, 2018.

While TDA’s proposed rule avoids the use of the word “registration,” the proposed rule, in practical terms, creates a mandatory registration requirement.  Under proposed 4 TAC §11.20, every single farm that grows produce for sale would be required to file a “survey” with the agency.  Farms that have a qualified exemption under 21 CFR §112.5 would be required to file annual paperwork, and the agency claims authority to use that submission to determine whether a farm is exempt from the substantive requirements.  See proposed 4 TAC §11.21-11.22.  This is mandatory registration, and FARFA’s comments will thus refer to it as such.

The Food Safety Modernization Act (FSMA), codified at 21 USC 301 et seq., does not require registration of farms.  HB 3227, codified at Section 91 of the Agriculture Code, which gave TDA authority to implement the Produce Safety Rule under FSMA, does not mention registration of farms.  As such, TDA lacks statutory authority to require farm registration.

At no point has the agency identified any specific federal or state statutory provision that would provide the basis for the regulatory requirement.  In conversations, the agency staff has provided one justification for the concept of mandatory registration: that it is “necessary” for TDA to implement the Produce Safety Rule, since it allegedly cannot fairly enforce the provisions on those farms that are subject to the rule otherwise.   In other words, the agency is concerned that it may be difficult to identify which farms are subject to the rule’s requirements.

But agency convenience is not a legal basis for mandatory registration.  Regulatory requirements that apply only to certain activities or certain businesses, but not others, are a common feature in many laws.  These laws don’t require that every single person who would be subject to regulations but for an exemption also file paperwork with the agency.  For example:

  • Businesses must pay sales tax on most items that they sell to consumers within the state. Businesses that sell only items that are not subject to sales tax, such as most food items, do not file anything with the Comptroller.
  • Employers with 50 or more employees must provide their employees with up to 12 weeks of unpaid leave annually under the Family Medical Leave Act. Employers who are exempt because of their size do not file anything with the Department of Labor.
  • Retailers with annual gross sales of less than $500,000 are exempt from the nutrition labeling requirements of the Federal Food, Drug, and Cosmetic Act without filing anything with the Food and Drug Administration.

Presumably, the Texas Comptroller, the DoL, and the FDA would all find it easier to enforce the law if every single business filed paperwork with them each year that provided the information needed to determine whether or not that business was exempt.  But that’s not how any of these laws work.

Under these laws, and FSMA, the statute sets out who is subject to the requirements.  Individuals and businesses read the law and determine whether they are exempt or not.  They don’t have to apply to an administrative agency to approve their exemption.

II.  The lack of statutorily mandated registration was intentional.

As an administrative agency, TDA has only that authority granted to it by statute. Thus, the simple fact that neither the federal nor the state statutes contain a provision authorizing TDA to require exempt farms to register with the agency means that the agency lacks authority for mandatory registration and the proposed rule is ultra vires.

In this case, however, there is an additional basis to find that the agency has overstepped its authority.  FSMA’s legislative history and structure provide evidence that the lack of a registration requirement was a deliberate decision by Congress.

At issue in the proposed rule is the application of the qualified exemption, often referred to as the Tester-Hagan amendment for the two Senators who championed it.  The qualified exemption is actually two-part provision, both of which exempt small-scale, direct-marketing producers from certain provisions of FSMA.

The first provision addresses the requirements for qualified exemptions from the new Preventive Controls rule, which applies to “facilities.”  Consistent with the 2002 Bioterrorism Act, farms are not classified as facilities.  See 21 USC 350d(c)(1) (“The term ‘facility’ … does not include farms ….”)  The 2002 Bioterrorism Act required facilities (but not farms) to register with the FDA.  See 21 USC 350d(a).  FSMA added the Preventive Controls requirements to that pre-existing registration provision for facilities. In exempting small-scale facilities from the new Preventive Controls rule, the Tester-Hagan Amendment required the facility to submit a statement to FDA attesting to the fact that he/she/it meets the requirements for the qualified exemption or providing a simplified HARPC plan.  See 21 USC 350g(l)(2)(B)

In contrast, the Tester-Hagan provision that governs farms under the Produce Safety Rule – the only rule that TDA has jurisdiction to implement – does not require registration nor any submittal to the agency.  The FSMA language simply sets out which farms are exempt from the new produce safety requirements and requires that the farms provide notification to consumers – but not the government.  See 21 USC 350h(f).  Congress’ decision to not require exempt producers to register or submit proof of their exemption controls TDA’s implementation of the Produce Safety Rule.

The fact that FSMA requires non-exempt facilities to register, but contains no such requirement for non-exempt farms, establishes that no farm (regardless of their size) should be required to register under the Produce Safety Rule.

Consistent with the statutory language and history, the FDA’s implementing regulations for FSMA require registration for facilities but not for exempt or qualified exempt farms.

FSMA is not the only statute that has one exemption that requires a filing and another exemption that does not.  For example, the Federal Food, Drug, and Cosmetic Act (FFDCA) exempts retailers who gross less than $500,000 annually from the nutrition labeling requirements.  That exemption is found in section 343(q(5)(d) of the statute, which makes no mention of any filing requirements – and the FDA’s implementing regulations similarly do not require any filing for those exempt retailers.  The FFDCA has another exemption, for businesses that employ fewer than 100 full-time employees and sell fewer than 100,000 units of that food item in the U.S. annually.  The statute provides that, to qualify for that exemption, the business must file an annual notice with FDA.  See 343(q)(5(E)(i)(III).  This example illustrates how the agency’s implementation of an exemption should reflect the statutory requirement – or lack of requirement – for a mandatory filing.

III.  The proposed rule improperly seeks to shift the burden of proof to the farmer rather than TDA.

Compounding the problem with the proposed mandatory registration is TDA’s intended response. The proposed rule provides that if a farm fails to submit the required paperwork within 60 days of the deadline each year, the agency will automatically do an inspection with the presumption that the farm is not exempt and is subject to the substantive requirements of the Produce Safety Rule. See proposed 4 TAC §11.22(c).

Neither FSMA nor HB 3227 creates such a presumption, and TDA cannot legally create one.  As with any law, the burden lies with the government to prove that an individual violated the law.  The agency cannot “bootstrap” one violation into another, claiming that the failure to comply with one requirement (filing paperwork) creates a presumption that the individual is violating another law.

Yet that would be the practical effect of this provision.  The requirements of the Produce Safety Rule are vast and costly.  They cover employee training, facilities and equipment, irrigation water testing, what types of soil amendments can be used and how, and much more.  The FDA’s estimates are that it would cost a small farm around $25,000 per year to comply. In practical terms, it is certain that almost no exempt farm would be in full compliance with these regulations.  Thus, the effect of creating the presumption that an exempt farm is not exempt (because it failed to file the survey) would be to find that the farm had violated the Produce Safety Rule’s substantive provisions.

As discussed above, the proposed requirement to file an “annual survey” is beyond the agency’s authority.  But even assuming for argument’s sake that the agency can legally require such registration, it still cannot use that requirement to inspect farms who are exempt from the Produce Safety Rule and impose fines and enforcement actions as if they were not exempt.

IV. The “egregious conditions” provision is vague and unenforceable.

The TDA’s proposed rule also includes novel provisions for inspections and enforcement actions based on “egregious conditions.” Specifically, the agency claims that it can enter the premises of any farm (including exempt farms) “to respond to any emergency involving an egregious condition.”  See proposed 4 TAC § 11.40(b).  The agency also claims that it can issue a “stop sale order,” halting the sale of perishable produce, “upon a finding of an egregious condition.”  See proposed 4 TAC § 11.42(a)

The term “egregious condition” does not appear anywhere in the relevant federal or state statutes or regulations.

Rather, this term is apparently found in the “on farm readiness review” manual, a document prepared by FDA and some state departments of agriculture.  The OFRR manual was prepared without public input, is not even available to the public at this time, and can be changed by the agencies at any time without any notice or process.  Moreover, the on farm readiness reviews are designed as non-regulatory actions, to help farmers identify changes they need to make in order to come into compliance.  The OFRR is a voluntary “conversation” between the grower and a reviewer.  https://www.nasda.org/foundation/food-safety-cooperative-agreements/on-farm-readiness-review.  Yet TDA is proposing to enshrine the term in regulations, and claim authority to enter any farm at any time and to stop sales from any farm based on this vague term.

Federal law already sets the standards for regulatory actions such as inspections or the recall of food.  The Federal Food, Drug, and Cosmetic Act, which FSMA amended, bars the sale of adulterated food.  See 21 USC §331.  FDA’s regulations implementing FSMA specifically provide that the requirements of the Produce Safety Rule apply in determining whether food is “adulterated.”  See §112.192(b).  The FFDCA also sets out the grounds and procedures for seizing items of food offered for sale, including placing an administrative restraint or detention order.  See  21 USC § 334. The federal law also set out when and under what conditions food producers can be inspected.  See 21 USC  §374.

TDA lacks the legal authority to create a new standard, nor is it a logical way for TDA to implement the Federal Produce Safety Rule; the federal standard should and does control. The fact that the proposed term is so broad and open to subjective interpretation, combined with the lack of public process in its development, means that the proposed provisions are not only unnecessary but also affirmatively harmful for producers.

V. The penalty provisions are vague and excessive.

The proposed rule includes a penalty matrix that would establish excessive fines and penalties.  Moreover, several of the provisions are vague and would leave growers vulnerable to high penalties based on entirely subjective determinations by agency personnel.

First, the proposal for a $1,500 fine for recordkeeping and other violations that specifically do not pose a risk to the public health is excessive.  The federal Produce Safety Rule covers building standards, equipment, water testing, application of compost & biological fertilizers, monitoring for wildlife in the fields, having pets or livestock on the farm, training employees, and more.  Even farms that are making a concerted good faith effort to comply are likely to have several minor violations simply because of the scope of the regulations.  The sheer volume of records that are required under the Produce Safety Rule (all of which must follow specific formats), also means that it is essentially a certainty that farms will have some record-keeping violations even when acting responsibly and in good faith.  And since penalties can accrue for each individual violation, the total fine could be extremely large. Violations that explicitly do not pose a public health risk should not be subject to such potentially large fines.

Second, the agency is using the vague “egregious conditions” term to create a category of penalties above and beyond those for violations that do pose a public health risk.  This vague term should not be the basis for fines of $5,000 to $10,000 per day.

Moreover, the agency proposes to assess such fines on top of stop sale orders.  The rationale for high daily fines is to create pressure for a business to stop the activity – but if the sales have halted, then such fines are purely punitive.  Yet these fines could be levied even on a grower who was not acting recklessly or willfully, since no state of mind is required under the proposed penalty matrix.

Last, the agency makes a distinction between “failing to allow” an inspection, and “refusing to allow” an inspection, with significantly larger fines for the latter.  What precisely is the difference?  Consider a farmer who does not believe that the TDA agent has a right to enter his property after hours without notice – but the TDA agent claims that there are “egregious conditions.”  Would not allowing the inspector to enter the property be “failing” or “refusing” to allow the inspection?  There does not appear to be any public health difference to justify a two- to three-times greater fine.

VI. Conclusion

While FARFA generally supports the TDA in overseeing implementation of the federal Produce Safety Rule in Texas, such implementation should be limited to the terms of the federal rule.  We thus object to requiring exempt farms to register with the agency.  Moreover, rather than claim broad new powers to inspect exempt farms without probable cause or to stop sales from farms using the vague term “egregious conditions,” the agency’s rule should reflect the federal statutory and regulatory standards.

If you have any questions, please contact me at Judith@FarmAndRanchFreedom.org



Judith McGeary
Executive Director
Farm and Ranch Freedom Alliance