Date: Mar 10, 1997
The Food Quality Protection Act of 1996 (FQPA) accomplished a removal of pesticide residues in processed foods from application of the Delaney anti-cancer clause. This change was strongly supported by the agricultural and food industries. In briefest summary, a "glitch" arises from the way this was accomplished.
Under the old law, pesticides in raw agricultural commodities were subject to registration and tolerance requirements with regard to residues. Pesticide residues in processed foods were subject to potential application of the "food additive" definition (and hence the Delaney Clause which applies to food additives). The intended "fix" does two things. First, it takes pesticide residues of all forms, whether on raw agricultural commodities or processed foods, out of the food additive definition. Second, it deletes from the definition of pesticide chemical the requirement that it be used in the production, storage, processing or transportation of food. The status of a substance as a pesticide chemical is made independent of its intended use. Taken together, these two changes make all pesticide residues subject to tolerance requirements, i.e., a food, raw or processed, is adulterated if it contains a pesticide residue that is not allowed in a tolerance set by EPA.
Here's the problem. Under the old law, where the presence of the pesticide in a processed food was inadvertent (as in cases seen from time to time where low levels of a pesticide are found in a food that are present not because it had been applied to the crop, but because of "spray drift," or just because it was used heavily in the region of the crop) the food was not automatically considered adulterated because it did not contain a pesticide or an unapproved food additive. The intended use of the substance had not resulted in it becoming a component of food, i.e., it got there inadvertently. Since such residues were not pesticides subject to the tolerance requirements nor food additives, the food was not per se adulterated, and would only be adulterated if the quantity of the residue was such that it "may render the food injurious to health." (1)
Now, under FQPA, such a residue, even in a highly processed commodity, would render the food adulterated unless there is a tolerance permitting its use. For hundreds of unintended residues, there are no such tolerances. Moreover, pesticides are inadvertently present in foods not only as a result of things like spray drift, which is a misuse, but from environmental conditions, e.g., being persistent in soils or being transported over long distance by wind or fog.
FQPA does allow EPA to exempt unavoidable, inadvertent pesticide residues from the definition of "pesticide chemical" if EPA feels that regulation can be better accomplished under other provisions of the Federal Food, Drug, and Cosmetic Act. However, to make this exception requires an affirmative regulation from EPA. Unless and until such regulations are issued, large quantities of crops and processed food products, which heretofore were perfectly lawful and safe, will now be per se adulterated subject only to FDA enforcement discretion.
From discussions we have had with FDA and EPA officials, we do not expect either agency to change their enforcement priorities or indeed even to begin to enforcing the Act against foods containing safe unavoidable inadvertent residues. The problem is that, even though FDA may decide not to take enforcement action, until EPA acts or the law is amended, both the government and the food industry are exposed to a lawsuit, say, from a "public-interest group," that would urge that such foods are adulterated and seek a declaratory judgment to that effect. They would only need to prove that pesticide chemicals are in fact present for which there are no tolerances or exemptions from tolerance. Moreover, we certainly don't like to advise clients that products containing low levels, demonstrably safe, of unavoidable pesticide residues are not lawful items of commerce.
Immediate remedial action should be undertaken by EPA to establish a generic tolerance regulation establishing an insignificant risk level for pesticide residues on any crop for which a specific tolerance has not been promulgated.
Title IV, the heart of The Food Quality Protection Act of 1996 (FQPA(2)), is designed to "eliminate longstanding problems posed by multiple standards for pesticides in raw and processed foods."(3) To accomplish this objective, a change has been made in the Federal Food Drug and Cosmetic Act (FFDCA) that leads to the unintended secondary effect of rendering both raw agricultural commodities (RACs) and processed food adulterated if they contain unavoidable, inadvertent low-level pesticide residues for which no tolerances or exemptions from tolerance have been established. On the surface, considering a RAC or processed food to be adulterated if it contains pesticide contamination may not seem new, but the change in the FFDCA that brings about this effect creates wide-ranging practical consequences.
Low-level pesticide residues have been detected for years. As monitoring programs for pesticide residues in RACs and food became more sensitive and extensive in the '80s, the discovery of low level, unavoidable inadvertent pesticide contamination became common. Under the FFDCA, the Federal government had wisely exercised its "discretion" to avoid initiating enforcement actions where the exposure to such contamination was so negligible as to present no public health or safety concerns. The FQPA does not purport to alter the enforcement priorities of the Food and Drug Administration (FDA), but it does alter the legal status of these contaminants. The result of this altered status will be a disruption of the food supply unless EPA acts under the authority provided in FQPA to prevent this result. Absent corrective action by EPA, the new law could even have the perverse effect of discouraging farmers and food processors from continuing the diligent monitoring for pesticide residues in their products. Some insight into the problem created by FQPA can be gained by examining the treatment of crops with problematic contaminants in California.
During the '80s, the State of California implemented a monitoring program for pesticide residues that was equal in extent and sensitivity to the existing Federal program. Unlike the Federal program, however, every time a pesticide residue was discovered for which there was no established tolerance the crop was impounded and destroyed, even if exposure was negligible. California state law defines any raw agricultural commodity or food containing even mere traces of a pesticide to be adulterated, without exception, in the absence of a tolerance or an applicable exemption from tolerance -- a per se rule of adulteration.
In the late '80s, farmers from California petitioned the U.S. Environmental Protection Agency to establish broad exemptions from tolerance for low level inadvertent unavoidable levels of pesticides on crops for which tolerances had not been established. The California Department of Food and Agriculture supported these efforts by providing extensive field study data confirming that the trace pesticide levels were unavoidable and inadvertent rather than the result of some mechanism such as misuse or rotation of crops into soil with residual pesticide.
The petitions are still pending today. EPA has justified its failure to intervene on the basis that the loss of crops was due to a defect in State law and that Federal action was not warranted. As explained below, EPA's justification was valid; crops that California was regarding as adulterated were not adulterated under Federal law. With the passage of the FQPA, however, the difference between California and Federal law on this issue has been virtually eliminated and some Federal response is now urgent.
Source, Nature and Level of Unavoidable Inadvertent Residues --
Pesticide contamination is considered to be inadvertent if it does not result from any pesticide use directly associated with producing, storing or transporting a commodity. It is considered to be both unavoidable and inadvertent if there are no measures that can be taken to avoid the contamination. Before a residue can be considered to be unavoidable and inadvertent, the possibility of misuse, rotational crop use, spray drift or runoff must be eliminated.
There are two primary sources of unavoidable inadvertent pesticide contaminants in food:
Absorption of very persistent, chlorinated hydrocarbon pesticides such as DDT, DDE, aldrin, dieldrin, heptachlor, and toxaphene from soil residues that remain from the historic widespread use of such pesticides; Absorption of heavily used pesticides that accumulate in air and may be transported over substantial distances to crops that were not treated.
For a number of contaminants of the first type, FDA has published action levels below which no enforcement action will be taken; no tolerances or exemptions from tolerance exist. Because of their persistence in the environment, pesticides like DDT and DDE are still being found in soil and absorbed by crops. These old chlorinated hydrocarbon pesticides are readily recovered and measured in almost any crop and in meat, milk, eggs, poultry and fish by FDA's multiresidue analytical methods for pesticides in food.(4) The second type, low level contamination created by airborne transport of pesticides, is possible on crops for which no tolerances have been set because any pesticide that is widely used may accumulate in air and be transferred to crops that have not been treated.
FDA's multiresidue analytical methods, which are used in the Federal monitoring programs for raw agricultural commodities and processed foods, and for market basket sampling of finished foods, can recover and measure hundreds of different pesticides in a single analysis of almost any commodity sampled, the exact number of residues and sensitivity being determined by the commodity, the particular pesticide residues of interest and the method options chosen. Typically the detection limit for a residue/commodity combination is between one and 50 ppb. The methods are designed to provide a rapid screen to detect and quantify any pesticide residues present. Pesticides that have been canceled or never registered in the U.S. are included in the method.
If pesticide contamination is found for which there is neither a tolerance nor an appropriate exemption from tolerance, a second analysis of the same test sample is conducted by a senior analyst. Additional methods may be used to enhance the detection process. If the residue is confirmed and the results of both analyses agree, an enforcement action such as seizure and commodity destruction -- as has happened in California -- may be initiated. For the reasons discussed below, the FQPA now makes Federal seizures a risk as well.(5)
The Key changes in FFDCA by FQPA --
In order to appreciate the significance of the changes in FFDCA, it is necessary to focus on certain key definitions. Prior to passage of the FQPA, Section 201(s) of the FFDCA(6) defined, in pertinent part, a food additive as follows:
The term "food additive" means any substance the intended use of which results in its becoming a component of any food , if such substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures to be safe under the conditions of its intended use; except that such term does not include -
(1) a pesticide chemical in or on a raw agricultural commodity; or (2) a pesticide chemical to the extent that it is intended for use or is used in the production, storage or transportation of any raw, agricultural commodity; or (3) . . .(4) for any substance used in accordance with the sanction or approval granted prior to enactment of this paragraph (5) . . .(6) . . .
(1) a pesticide chemical in or on a raw agricultural commodity; or
(2) a pesticide chemical to the extent that it is intended for use or is used in the production, storage or transportation of any raw, agricultural commodity; or
(3) . . .
(4) for any substance used in accordance with the sanction or approval granted prior to enactment of this paragraph
(5) . . .
(6) . . .
The FQPA amended subparagraphs (1) and (2) above to read as follows:
(1) a pesticide chemical residue in or on a raw agricultural commodity or processed food; or (2) a pesticide chemical; or
(1) a pesticide chemical residue in or on a raw agricultural commodity or processed food; or
(2) a pesticide chemical; or
The above modification of the definition of the term "food additive" was central to the drafters' intent to eliminate the distinction that existed before FQPA between the applicable clearance mechanisms for pesticide chemical residues on raw agricultural commodities and the identical residues when they are carried over into processed foods.
The FQPA also provides an important amendment in the definition of the term "pesticide chemical." Prior to FQPA, the FFDCA provided the following definition at Section 201(q):
(q) "Pesticide chemical" means any substance which, alone, in chemical combination or in formulation with one or more other substances is a pesticide within the meaning of the Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 135-135(k)] as now enforced or as hereafter amended, and which is used in the production, storage, or transportation of raw agricultural commodities.
FQPA has amended the definition of "pesticide chemical" at Section 201(q) and has defined a new term, "pesticide chemical residue." The definitions, and a special (q)(3) provision dealing with certain pesticide chemical residues, read as follows:
(q)(1) the term "pesticide chemical" means any substance that is a pesticide within the meaning of the Federal Insecticide, Fungicide, and Rodenticide Act, including all active and inert ingredients of such pesticide.
(2) the term "pesticide chemical residue" means a residue in or on a raw agricultural commodity or processed food of -
(A) a "pesticide chemical"; or (B) any other added substance that is present on or in the commodity or food primarily as a result of the metabolism or other degradation of a pesticide chemical.
(A) a "pesticide chemical"; or
(B) any other added substance that is present on or in the commodity or food primarily as a result of the metabolism or other degradation of a pesticide chemical.
(3) notwithstanding paragraphs (1) and (2), the Administrator may by regulation except a substance from the definition of "pesticide chemical" or "pesticide chemical residue" if -
(A) its occurrence as a residue on or in a raw agricultural commodity or processed food is attributable primarily to natural causes or to human activities not involving the use of any substance for a pesticidal purpose in the production, storage, processing, or transportation of any raw agricultural commodity or processed food; and (B) the Administrator, after consultation with the Secretary, determines that the substance more appropriately should be regulated under one or more provisions of this act other than Sections 402(a)(2)(B) and 408.
(A) its occurrence as a residue on or in a raw agricultural commodity or processed food is attributable primarily to natural causes or to human activities not involving the use of any substance for a pesticidal purpose in the production, storage, processing, or transportation of any raw agricultural commodity or processed food; and
(B) the Administrator, after consultation with the Secretary, determines that the substance more appropriately should be regulated under one or more provisions of this act other than Sections 402(a)(2)(B) and 408.
The revised definition of "pesticide chemical" is more expansive that the original in that it eliminates the need for the substance to have been "used in the production, storage or transportation of [food]," and it explicitly includes inert ingredients within its scope. This expansion is further elaborated in the newly defined term "pesticide chemical residue," which, as reflected by the language in paragraph (q)(3)(A), includes substances that were not used for pesticidal purposes on the crop which has the residue, i.e., "attributable primarily to natural causes or to human activities not involving the use of any substance for a pesticidal purpose ." These changes set the stage for an unintended problem created by FQPA with regard to unavoidable and inadvertent levels of pesticides in both raw agricultural commodities and processed foods.
In providing the authority at paragraph (q)(3) for the Administrator to decide whether and how pesticide chemical residues should best be regulated, the definition makes it explicit that trace levels of pesticides which result from natural causes or human activities not involved in the use of any substance for a pesticidal purpose, i.e., production, storage, processing or transportation of any commodity or food, still fall within the scope of the pesticide chemical residue definition.(7) Absent such express language in the statute, this conclusion would not necessarily follow. The relevant definitions of "residue" in Webster's II New Riverside Dictionary are:
The remainder of something after removal of a part; and Matter left after completion of an abstractive chemical or physical process, such as evaporation, combustion, distillation, or filtration.
The remainder of something after removal of a part; and
Matter left after completion of an abstractive chemical or physical process, such as evaporation, combustion, distillation, or filtration.
When a chemical is used for a pesticidal purpose in the production, storage, processing or transportation of food, the level of pesticidal chemical in or on the food, i.e., the amount remaining after evaporation, washing and/or processing in some manner, is consistent with the dictionary definition of residue. The pesticide is applied; residue remains. It makes much more sense from a semantic standpoint to regard chemicals which appear in food as a result of general background levels in the environment, rather than as a result of use of the chemical for a pesticidal purpose, as contaminants -- not residues.
Even though FQPA has chosen to define environmental contamination by pesticide chemicals within the more broadly defined term "pesticide chemical residues," the term, "Q3 contamination" will be used from here on to refer to these unavoidable, inadvertent levels of pesticide chemicals that may at times be detectable in foods and are eligible for exclusion from the residue definition if EPA promulgates a rule to that effect under Section 201(q)(3).(8)
So, how is the situation now different than it was before? Prior to FQPA, Q3 contaminants adulterated food, if at all, only if they could render food injurious to health. The analysis below examines the effects of FQPA first on Q3 contaminants in processed foods.
Processed Foods --
Prior to FQPA, Q3 contaminants were not defined by statute to render food adulterated, per se. Of course, per se adulteration status did apply to pesticide chemicals that were used on RACs; in the absence of a tolerance or exemption from tolerance, the presence of even a trace of a pesticide chemical so used adulterated RACs.
The two basic provisions by which food can be considered adulterated with chemical contaminants under FFDCA are Section 402(a)(2)(A) and Section 402(a)(1).(9) Section 402(a)(2)(A), by cross reference to Section 406, appears to create a per se rule of adulteration any time food contains any added poisonous or deleterious substance, even if its occurrence is unavoidable or inadvertent, unless FDA has promulgated a formal tolerance. However, in Community Nutrition Institute v. Young, 476 U.S. 974 (1986), the Supreme Court held that formal tolerances were not required and upheld FDA's reliance upon action levels. Furthermore, the critical phrase "poisonous or deleterious" in Section 406, which is not defined in the statute, has never been defined by FDA. At the trace levels that Q3 contaminants might appear in food as a result of exposure to general background levels of pesticides in the environment, it is doubtful that they could be considered poisonous and deleterious. Therefore, the presence of insignificant levels of Q3 contamination does not create adulteration per se under Section 402(a)(2)(A).
The mere presence of a Q3 contaminant does not constitute per se adulteration under Section 402(a)(1) either. This provision, which has been carried forward since the 1906 Pure Food and Drug Act, deems food to be adulterated if it contains added substances which may render food injurious to health. In implementing this provision, FDA has established action levels by which it informed the industry as to the level of contamination above which FDA might be inclined to bring an enforcement action. In such cases, FDA had the burden of proving that the contaminant would render food injurious to health. Where the contamination levels were extremely low, a food processor was free to conclude that there is no adulteration under 402(a)(1).
The old statutory framework imposed no disincentive for food processors to analyze their products carefully for pesticide residues and to be fully informed with regard to the presence of any and all pesticide chemicals. While unexpected residues are always a cause for concern, a food processor could comfortably conclude that its products were not adulterated by the presence of Q3 contaminants as long as the level in food was sufficiently low. Such products could be introduced into interstate commerce with confidence that such trace, inadvertent and unavoidable contamination, i.e., Q3 contamination, did not cause the food to be adulterated.
Under the old scheme, FDA's forbearance of enforcement was frequently described as an exercise of its discretion. That was, however, a misnomer since it would be an abuse of discretion for FDA to bring an enforcement action when no violation had occurred. An enforcement action could succeed only if FDA secured a judicial determination that the Q3 contamination levels were sufficiently high so as to render food injurious to health.(10) The Court, not FDA, made the binding determination that the food was adulterated. At the extremely low levels that typically characterize Q3 contamination, an enforcement action would not lie.
As noted above, under FQPA the mere presence of Q3 contamination in a processed food without a tolerance or exemption automatically adulterates the food. To win an enforcement action, FDA need only prove that the pesticide chemical is in fact present and that no tolerance or exemption from tolerance exists. It is, in effect, the analytical chemist who makes the critical finding of adulteration. The violation is clear. The only issue is whether FDA will decide to bring an enforcement action if the product is delivered for introduction into interstate commerce.
The statutory options with regard to Q3 contamination of RACs prior to FQPA were similar to the options for processed food -- adulteration arose only if food was rendered injurious to health. To be sure, there was a per se adulteration rule for pesticide chemicals in RACs prior to FQPA. Section 402(a)(2)(B), by cross reference to Section 408 of the FFDCA, defined food to be adulterated if it was a raw agricultural commodity and it contained pesticide chemicals that were not generally recognized as safe (GRAS), not in compliance with a tolerance regulation, or had not been deemed exempt from the need for a tolerance. It was irrelevant whether the level of the pesticide was capable of rendering food injurious to health.
This per se rule operated, however, only with regard to "pesticide chemicals." Prior to FQPA, as noted above, that term was defined to include a specific reference to "use" of the substance in the production, storage or transportation of food. Under this earlier definition, a Q3 contaminant was not a "pesticide chemical" since it would not have been used in the production, storage or transportation of the raw agricultural commodities in which it was found. Consistent with this emphasis on "use," prior to FQPA EPA's authority to promulgate regulations creating exemptions from tolerances was limited by section 408(c) "to the use (emphasis added) [of a pesticide chemical] in or on any or all raw agricultural commodities ." Indeed, it is the elimination of the "use" requirement that has spawned the need for a special provision dealing with Q3 contaminants.
As defined in FIFRA, a chemical substance becomes a pesticide only when its intended to be so used. As noted above, however, the new "pesticide chemical residue" definition includes any substance that had been a component of a pesticide without regard for whether the specific "residue" at issue resulted from use of the pesticide. Accordingly, the argument that unavoidable and inadvertent contamination is not the direct result of the "intended use" of the contaminant and, therefore, that the contaminant is not subject to the per se rule for pesticide chemicals cannot be comfortably maintained as long as a pesticide was involved in a chain of events by which the substance entered the environment.(11)
The analysis of 402(a)(2)(A), and 402(a)(1), previously described with regard to processed foods is equally applicable to RACs. Until FQPA, one could reasonably conclude for RACs, as well as processed foods, that the presence of Q3 contamination of a substance with no established tolerance or exception from tolerance did not constitute per se adulteration. Now the mere presence of Q3 contamination in a RAC without a tolerance or exemption automatically adulterates the RAC. To win an enforcement action now, FDA need only prove the presence of a pesticide chemical residue that is not authorized by a tolerance or exemption from tolerance. It is the analytical chemist who makes the essential finding of adulteration. The only issue is whether FDA will decide to bring the enforcement action if the RAC is introduced into commerce, and what penalty it will seek. Again the enforcement issue has changed. It is no longer a question of whether an enforceable violation has occurred; the question is simply whether the violation will be enforced.
Notwithstanding the technical distinctions discussed above, one essential issue is whether the changes brought about by FQPA are likely to affect FDA's enforcement priorities (not discretion) with regard to Q3 contamination. Since FDA, with concurrence from EPA, has always claimed to be exercising its enforcement discretion with regard to Q3 contamination, and since FQPA generally does not alter FDA's enforcement role with regard to adulterated foods, there is, perhaps, no reason to expect significant change in enforcement by FDA as a result of FQPA. Even if FDA's enforcement priorities do not change, however, the fact remains that the status quo has been dramatically altered by FQPA.
Actually, FQPA does make one change to FDA's enforcement powers regarding pesticide chemical residues beyond the change brought about by creating new per se violations. As amended by section 407 of FQPA, section 303(q) provides that persons responsible for the introduction into interstate commerce of food that is adulterated under the per se adulteration standard of section 402(a)(2)(B) can be optionally subjected to a civil money penalty. Furthermore, if a civil money penalty has been assessed, criminal sanctions and/or an injunctions against the responsible person cannot be brought. Also, the adulterated food may not be seized!
Congress intended that the civil money penalty should be an alternative to destruction of the food for situations where the risk to public health from the "violative pesticide chemical residue," e.g., Q3 contamination, is insignificant. This potentially provides a convenient avenue for FDA to enforce Q3 contamination violations: It may simply impose a nominal fine. Curiously, however, FQPA explicitly makes farmers ineligible for this alternative enforcement. While this exclusion is understandable where the violation does not involve Q3 contaminants (since illegal pesticide use is the likely cause) blameless farmers deserve access to this alternative to criminal prosecution, injunction and seizure as much as the food processors and distributors where Q3 contamination is involved.
The change in status quo has serious implications in that farmers and food processors have now lost their capacity to determine that Q3 contaminants do not adulterate food when the contamination does not render food injurious to health. By clearly defining Q3 contaminants as requiring tolerances or exemptions from tolerance, FQPA has now made it illegal for a farmer or food processor to introduce food into interstate commerce if a pesticide not covered by a tolerance or exemption from tolerance is present. As a strict liability statute, the illegal act occurs when the food is introduced into interstate commerce, whether the existence of the Q3 contaminant is known or not. A monitoring program that detects such residues merely provides evidence of the violation. Under the new law, farmers and food processors might well decide not to generate such incriminating evidence. No farmer can be confident that he is not violating the FFDCA whenever any commodity is introduced into interstate commerce.
While FDA might readily give assurance that it would not bring an enforcement action, the authority to exercise such discretion rests solely with FDA and it has not yet issued a broad no enforcement position. A farmer or food processor has no legal capability to make a self-determination that the violation is not significant. Farmers and food processors are now suddenly and solely dependent on FDA's discretion to avoid prosecution, seizure or injunction with regard to their interstate distribution of products that would be proven to be adulterated if an ambitious analytical chemist undertook a sufficiently rigorous analysis. Unless the Administrator acts under Section 402(q)(3)(B) to designate a more appropriate regulatory mechanism for Q3 contaminants, virtually all products are in jeopardy.
The quandary created for farmers and food processors is compounded by the fact that state pesticide laws typically define state law violations in terms of the Federal statute. The unyielding approach that California has had with regards to Q3 contaminants is likely now to become unavoidable in other states.
Options for Solving the Problem
The Need to Initiate Action from the Outside --
EPA's plate is already full of high priority activities involving implementation of the Food Quality Protection Act of 1996. Left to its own devices, it seems unlikely that the Agency will establish a regulatory system to deal with Q3 contaminants any time soon. It may be that EPA has not yet identified the existence of this particular problem, although the problem could quickly become urgent.
While a lack of enforcement appears to be the option preferred by FDA, this solution is only as durable as the resolve of the officials involved. In the face of public criticism, such resolve could easily evaporate. As noted above, at the state level the destruction of adulterated commodities, and the widespread, unnecessary losses of perfectly good food may be the only alternative. Furthermore, the resource base available to the Federal government for sampling and analysis of food commodities has been increased substantially with the passage of FQPA, and the discovery of residues for which there are no tolerances, and the consequent loss and economic damage, can be expected to grow quickly as monitoring programs are expanded.
Efforts should begin immediately to urge EPA to fix the Q3 contamination conundrum created by FQPA.
Available Tools --
1). With the amendments of the FQPA, any person may now petition EPA under Section 408(d) of the FFDCA to issue regulations "establishing, modifying or revoking" a tolerance or exemption from tolerance. At its own initiative EPA may do the same under Section 408(e) of the FFDCA. 2). EPA may also under Section 201(q)(3) of the amended FFDCA by regulation except a substance from the definition of pesticide chemical or pesticide chemical residue.
1). With the amendments of the FQPA, any person may now petition EPA under Section 408(d) of the FFDCA to issue regulations "establishing, modifying or revoking" a tolerance or exemption from tolerance. At its own initiative EPA may do the same under Section 408(e) of the FFDCA.
2). EPA may also under Section 201(q)(3) of the amended FFDCA by regulation except a substance from the definition of pesticide chemical or pesticide chemical residue.
Options for Solving the Problem --
1). Petition for tolerances for unavoidable inadvertent residues on an individual pesticide basis.
This option has been tried before. In May of 1988, a family farming operation located in Oakland and Modesto, California called Ratto Bros. Inc. submitted requests to EPA for the establishment under section 408(e) of the FFDCA of tolerance for unavoidable inadvertent residues of four major pesticides used extensively in the San Joaquin Valley. The exemptions were requested for five major specialty crop groupings. Ratto Bros. Inc. grows a mix of approximately 30 different minor vegetable and herb crops at a time, 12 months a year. The tolerance levels proposed by Ratto Bros. Inc. were below the levels that would be expected from direct use or spray drift of the pesticides, thereby allowing a distinction between unavoidable inadvertent residues and residues from improper applications to be made on the basis of measured residue levels. EPA has never acted on the petitions.
A few years earlier, the state of California had initiated its own major monitoring program for pesticide residues in RACs and food. Within a few years, the state was analyzing more samples annually than the Federal government. Like the Federal program, California used a sophisticated multiresidue method that could measure hundreds of different pesticide residues in a wide range of commodities. It was inevitable that the state would soon begin finding unavoidable inadvertent residues in crops for which few pesticides were registered.
The approach first taken in the Ratto case of applying for tolerances for one pesticide active ingredient residue at a time as they are detected is a slow way to solve the problem.
2). Establish a generic tolerance for all unavoidable inadvertent residues in all food commodities.
In support of the Ratto Bros. Inc. request to EPA, the state of California designed a major study to confirm the existence of unavoidable inadvertent pesticide residues. During the winter of 1989, an extensive sampling and analysis study of air, moisture from fog, rain and indicator plants was initiated involving several different pesticides that were widely used in the San Joaquin Valley. Pesticide levels were found to accumulate and to equilibrate in air over a broad geographic area, particularly during periods of temperature inversion, and to be absorbed by indicator plants to the same level in locations where pesticides were not used as they were in locations adjacent to pesticide applications.
A report of the California study was submitted to EPA and the request for tolerances expanded to a generic basis.(12) It was also pointed out to EPA that Canada has a regulation that specifies a generic tolerance of 0.1 ppm for unavoidable inadvertent residues and that the lack of such a generic tolerance in the U.S. is viewed as a non-tariff trade barrier. For pesticide/crop combinations of special concern in Canada, lower tolerances are established or the generic tolerance is not applied.
The generic tolerance approach also parallels the regulatory reform efforts of FDA in establishing a threshold of regulation for migrants from food packaging materials. Under an FDA rule published on July 17, 1995,(13) a food additive regulation is not required for a component of a packaging material if its potential contribution to the diet will be less than 0.5 ppb. 21 C.F.R. 170.39, 171.8. This approach is appealing in that EPA does not need to start from scratch. It needs only expand the science based concept in FDA's Threshold of Regulation Rule to pesticide residues. This "fix" has added appeal in that it could created a simple health based decision process that applies not only to Q3 contaminants but things like spray drift as well. EPA would still enforce cases of spray drift under FIFRA, but decisions regarding the safety of the crop could be made separately on a scientific basis.
3). Petition EPA to use its new rule making authority under Section 201(q)(2)(B) of the FFDCA to exclude Q3 contaminants from the definition of "pesticide chemical residue."
This third option would restore the status quo for pesticides before the passage of the FQPA. This option would not immediately solve the problem but would allow EPA and FDA to develop a regulatory framework for management of pesticide residues without tolerance that are determined to be unavoidable and inadvertent. Q3 contaminants would not be unregulated but would be controlled under Section 402 as contaminants rather than as pesticide chemicals. Crops would no longer be per se adulterated, but remedial measures could be taken, which might include crop destruction, in cases where there were legitimate health or safety concerns. The disadvantage to this approach is that it would not necessarily solve state regulatory problems like those experienced in California.
4). FDA adopts an enforcement moratorium vis-a-vis Q3 contamination unless food is rendered injurious to health or a relevant tolerance is issued by EPA.
For the short term, one hopes that the final option is arguably already in place, even though there has been no official announcement. A formal policy statement on the issue would be welcome. For the long term, the second option appears to be most attractive. Keller and Heckman LLP proposes working with new or established coalitions of farmers, farm organizations, food processors and food industry organizations, with support from the U.S. Congress and state governments, particularly California, to prepare and submit a petition to EPA for rule making and otherwise to pursue a solution to the problem of Q3 contaminants in raw agricultural commodities and processed foods.
1. See Section 402(a)(1) of the Federal Food, Drug and Cosmetic Act.
2. Public Law 104-170, August 3, 1996.
3. See USEPA, Office of Pesticide Programs, Highlights of the Food Quality Protection Act of 1996.
4. See: Food and Drug Administration, U.S. Department of Health and Human Services, 1994, Pesticide Analytical Manual Volume I: Multiresidue Methods, 3rd Edition, revised September, 1996.
5. The risk is particularly acute for imports since they may be stopped at the port of entry by FDA if the product merely appears to be adulterated; furthermore, the opportunities for appeal of an import detention are limited.
6. Unless otherwise indicated, all citations are to the FFDCA.
7. Section 408(l)(4) authorizes EPA to establish special tolerances or exemptions for residues of canceled or suspended pesticide chemicals that "unavoidably persist in the environment and thereby [will] be present in or on a food." Presumably, such "residues" would meet the criteria of section 201(q)(3)(A) and be eligible for regulation under authority other than section 402(a)(2)(B) and 408, if it is determined that regulation under other provisions of the FFDCA would be more appropriate. These contaminants had not previously been regulated under section 402(a)(2) and 408 as pesticide chemicals that required a tolerance or exemption from tolerance; rather, FDA had relied upon informal action levels to determine when residues of persistent, canceled pesticides adulterated food. While FQPA provides a transition provision at section 408(j)(1) to extend existing tolerances for these contaminants until new tolerances are issued under section 408(l)(4), there are no formal tolerances in existence for persistent canceled pesticides that can be affected by this transition provision. No transition provision is explicitly applicable to informal action levels.
8. While the focus of the paper is on Q3 contaminants, the new pesticide chemical definition and the exemption authority in section 201(q)(3) might also capture substances that cannot be deemed contaminants. Indeed, because the term "used in production " has been deleted from the amended definition of the term "pesticide chemical," an inference is created that the status of a substance as a pesticide chemical is independent of its intended use. Embracing this inference, however, leads to completely illogical conclusions.
Many substances have been selected for use as pesticide inert ingredients because their safety in or on food had already been established, as evidenced by the existence of food additive regulations. If the fact that a substance is occasionally used as a component of a pesticide makes it forever a pesticide chemical, then the parallel use of the substance for its technical effects as a food ingredient would no longer be a food additive because all pesticide chemicals are excluded from the definition of "food additive." It is also interesting to note that under section 408(j)(2), the previously applicable food additive regulations would be deemed to be regulations issued under the revised section 408 and, under section 408(g), would be required to undergo review by EPA under the new safety criteria established by FQPA.
If the inference were taken to such an illogical extreme, at least EPA would have the authority under section 201(q)(3) to reestablish the status quo for these "Q3 additives," as well as resolve the issue discussed above regarding Q3 contaminants. These "Q3 additives" are clearly "a 'residue' in processed food attributable to human activities not involving use for a pesticidal purpose in the production storage, processing, or transportation of food.
We believe that the "Q3 additive" scenario does not arise because such substances have never been pesticides as defined by FIFRA. Substances added to food for their technical effect in or on food are food additives unless they qualify for an exemption from that definition. The identical substance in food would be a pesticide chemical residue only when it comes to be present in food from having been a pesticide (or component of a pesticide). Under FQPA, however, it is a pesticide chemical residue regardless of whether it is the result of "use" of the pesticide on the commodity.
9. One might wonder why FDA has never attempted to regulate Q3 contamination under Section 402(a)(2)(C) by considering unavoidable and inadvertent pesticide residuals to be food additives. A food additive automatically adulterates food unless it is used in accordance with an applicable food additive regulation. Indeed, FDA successfully argued this position in a case involving DDT contamination of processed fish. United States v. Ewig Bros. Co., Inc., 502 F. 2d 715 (7th Cir. 1974). However, the Ewig decision has not been applied by FDA. Despite the ease with which the Ewig court dispensed with the issue of intended use, Q3 contamination is not intended use as FDA traditionally interprets the food additive definition. Even if one were to assume that unavoidable, inadvertent contamination was the result of intended uses of a pesticide, the levels typically involved (unlike in the Ewig case) are so low that the contaminating substance could be deemed generally recognized as safe (GRAS). Substances which are GRAS for their intended use are excluded from the definition of the term "food additive". Accordingly, FDA could not automatically deem a product adulterated simply because no food additive regulation (tolerance) was applicable if the level was suitably low.
10. To be sure, the courts typically extend deference to FDA's judgement as to the level of a substance that would render a food injurious to health. Making the scientific judgement that a level of Q3 contamination would render food injurious, however, is a fundamentally different exercise than deciding not to bring an enforcement action against food that is adulterated.
11. The status of a chemical substance as a pesticide chemical residue, or not, appears to depend upon the lineage of the molecules at issue. If any of them were released into the environment as a result of their use in or as a pesticide (of any type for any purpose), the presence of the substance in food would appear to require a tolerance. If the substance were released into the environment as a result of non-pesticidal uses, then adulteration occurs, as it did before FQPA, only if the food may be rendered injurious to health by the presence of the substance. It is worth noting that in a different context under the FFDCA where the lineage of a contaminant was at issue (mercury in swordfish: naturally occurring or an "added" substance), FDA may apply the stricter regulatory standard applicable to "added" substances as long as FDA can establish (as it is generally able to do) that some molecules of the type that are alleged to be contaminating food entered the environment as a result of the activities of man. United States v. Anderson Seafood, Inc., 622 F. 2d 157 (5th Cir. 1980). If an inferred source approach to pesticide chemical residues were adopted, the consequences would be disastrous.
12. B. Turner, S. Powell, N. Miller and J. Melvin, November 1989, A Field Study of Fog and Dry Deposition as Sources of Inadvertent Pesticide Residues on Row Crops, Environmental Hazards Assessment Program, Environmental Monitoring and Pest Management Branch, Division of Pest Management, Environmental Protection and Worker Safety, Department of Food and Agriculture, State of California, Report No. 89-11.
13. 60 FR 36582-36596, July 17, 1995, "Food Additives: Threshold of Regulation for Substances Used in Food-Contact Articles; Final Rule."