[Federal Register Volume 60, Number 114 (Wednesday, June 14, 1995)]
[Notices]
[Pages 31300-31308]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-14683]



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ENVIRONMENTAL PROTECTION AGENCY
[OPP-260055; FRL-4944-2]


Pesticide Tolerances; Partial Response to Petition to Modify EPA 
Policy

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice; Response to Petition.

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SUMMARY: This notice responds in part to a petition filed with EPA by 
the 

[[Page 31301]]
National Food Processors Association and other food and grower trade 
associations. That petition sought the repeal or revision of several 
EPA policies and interpretations related to how EPA coordinated actions 
under its various statutory authorities over pesticide residues in 
food. EPA regulates pesticides under the Federal Insecticide, 
Fungicide, and Rodenticide Act and sections 408 and 409 of the Federal 
Food, Drug, and Cosmetic Act. Although EPA has not resolved all of the 
policy questions raised by the NFPA petition, EPA has concluded that 
changes are warranted to its policy concerning when FFDCA section 409 
is applicable to a pesticide use and several related legal 
interpretations.

FOR FURTHER INFORMATION CONTACT: By mail: Niloufar Nazmi, Special 
Review and Reregistration Division (7508W) or Jean Frane, Policy and 
Special Projects Staff (7501C), Environmental Protection Agency, 401 M 
St., SW., Washington, DC 20460. Telephone numbers: 703-308-8028 or 703-
305-5944; e-mail: [email protected]. or 
[email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Introduction
II. Background
A. Statutory Background
B. EPA Coordination of the Statutory Provisions Governing Pesticides
III. The NFPA Petition
IV. Summary of EPA's Partial Response to NFPA Petition
V. Concentration Policy
A. General Issues
B. Monitoring Data and the Concentration Policy
C. Revisions to the Concentration Policy
    1. Introduction and summary.
    2. Factors relied upon by EPA in determining whether a pesticide 
which concentrates in fact is likely to produce residues in 
exceedance of the section 408 tolerance.
    3. Other factors potentially relevant to whether residues exceed 
the section 408 tolerance.
    4. Evaluation of factors.
    5. Conclusion.
VI. Ready to Eat
A. NFPA's Argument and Views of Commenters
B. EPA's Response
    1. The definitional issue.
    2. Enforcement approach.
    3. Animal feeds.
    4. Future actions.
VII. Are EPA's Policies Rules That Have Not Been Properly 
Promulgated?

I. Introduction

    In Les v. Reilly, 968 F.2d 985 (9th Cir. 1992), cert. denied, 113 
S.Ct. 1361 (1993), the Ninth Circuit U.S. Court of Appeals held that 
the Delaney anti-cancer clause in the food additives provision of the 
Federal Food, Drug, and Cosmetic Act was not subject to an exception 
for pesticide uses which pose a de minimis cancer risk. Prior to the 
decision becoming final, food processors and growers filed a petition 
with EPA challenging a number of policies and interpretations relating 
to how EPA implements its authority under the FFDCA. The petition 
proposes policies and interpretations that would reduce the impact of 
the Les decision. This notice responds to the petition in part.

II. Background

A. Statutory Background

    Pesticide residues in human and animal food in the United States 
are regulated under provisions of the Federal Food, Drug and Cosmetic 
Act (FFDCA) and the Federal Insecticide, Fungicide and Rodenticide Act 
(FIFRA). The interplay between sections 402, 408 and 409 of the FFDCA 
and, to a more limited extent, between the FFDCA and FIFRA, have 
created a complex, and sometimes contradictory, statutory framework 
underlying residue regulation in food.
    Before a pesticide may be sold or distributed, it must be 
registered under the FIFRA. 7 U.S.C. 136 et seq. To qualify for 
registration, a pesticide must, among other things, perform its 
intended function without causing ``unreasonable adverse effects on the 
environment.'' 7 U.S.C. 136a(c)(5). The term ``unreasonable adverse 
affects on the environment'' is defined as ``any unreasonable risk to 
man or the environment taking into account the economic, social and 
environmental costs and benefits of the use of any pesticide.'' 7 
U.S.C. 136(bb).
    The FFDCA, 21 U.S.C. 301 et seq., authorizes the establishment by 
regulation of maximum permissible levels of pesticides in foods. Such 
regulations are commonly referred to as ``tolerances.'' Without such a 
tolerance or an exemption from the requirement of a tolerance, a food 
containing a pesticide residue is ``adulterated'' under section 402 of 
the FFDCA and may not be legally moved in interstate commerce. 21 
U.S.C. 331, 342. EPA was authorized to establish pesticide tolerances 
under Reorganization Plan No. 3 of 1970. 5 U.S.C. App at 1343 (1988). 
Monitoring and enforcement of pesticide tolerances are carried out by 
the U.S. Food and Drug Administration (FDA) and the United States 
Department of Agriculture (USDA).
    The FFDCA has separate provisions for tolerances for pesticide 
residues on raw agricultural commodities (RACs) and for residues on 
processed food. For pesticide residues in or on RACs, EPA establishes 
tolerances, or exemptions from tolerances when appropriate, under 
section 408. 21 U.S.C. 346a. EPA regulates pesticide residues in 
processed foods under section 409 which pertains to ``food additives.'' 
21 U.S.C. 348. Maximum residue regulations established under section 
409 are commonly referred to as food additive tolerances or food 
additive regulations (FARs). Section 409 FARs are needed, however, only 
for certain pesticide residues in processed food. Under section 
402(a)(2) of the FFDCA, a pesticide residue in processed food generally 
will not render the food adulterated if the residue results from 
application of the pesticide to a RAC and the residue in the processed 
food when ``ready to eat'' is below the RAC tolerance set under section 
408. This exemption in section 402(a)(2) is commonly referred to as the 
``flow-through'' provision because it allows the section 408 raw food 
tolerance to flow through to the processed food form. Thus, a section 
409 FAR is only necessary to prevent foods from being deemed 
adulterated when the concentration of the pesticide residue in a 
processed food when ``ready to eat'' is greater than the tolerance 
prescribed for the RAC, or if the processed food itself is treated or 
comes in contact with a pesticide.
    To establish a tolerance regulation under section 408, EPA must 
find that the regulation would ``protect the public health.'' 21 U.S.C. 
346a(b). In reaching this determination, EPA is directed to consider, 
among other things, the ``necessity for the production of an adequate, 
wholesome, and economical food supply.'' Id. Prior to establishing a 
food additive tolerance under section 409, EPA must determine that the 
``proposed use of the food additive [pesticide], under the conditions 
of use to be specified in the regulation, will be safe.'' 21 U.S.C. 
348(c)(3). Section 409 specifically addresses the safety of 
carcinogenic substances in the so-called Delaney clause which provides 
that ``no additive shall be deemed safe if it has been found to induce 
cancer when ingested by man or animal or if it is found, after tests 
which are appropriate for the evaluation of the safety of food 
additives, to induce cancer in man or animal * * *.'' Id. Although EPA 
has interpreted the general standard under section 408 to require a 
balancing of risks and benefits, where a pesticide which is an animal 
or human carcinogen is involved, the section 409 

[[Page 31302]]
Delaney clause, in contrast to section 408 and FIFRA, explicitly bars 
such balancing no matter how infinitesimal the potential human cancer 
risk. Les v. Reilly, 968 F.2d at 989.

B. EPA Coordination of the Statutory Provisions Governing Pesticides

    In its administration of FIFRA and FFDCA sections 408 and 409, EPA 
has specified that FIFRA registrations for food-use pesticides will not 
be approved until all necessary tolerances and food additive tolerances 
have been obtained. 40 CFR 152.112(g). As a policy matter, EPA has 
taken a similar approach to FFDCA sections 408 and 409, not granting 
section 408 tolerances until needed section 409 FARs have been granted.
    This linkage of its statutory authorities has been described by EPA 
as its coordination policy. Basically, EPA's coordination policy is an 
expression of EPA's intent to take into account all of the applicable 
provisions governing pesticides in taking action under any one of the 
three. EPA's view has been that it should not be approving pesticide 
uses under one of the three provisions if an approval needed under one 
of the other provisions cannot be obtained.
    EPA's concentration policy establishes the criterion as to when 
approval is needed for food-use pesticides under FFDCA section 409, and 
hence when the Delaney clause applies. Generally, EPA has used a 
``concentration in fact'' standard as the test of whether a use needs a 
section 409 FAR. The concentration in fact standard focuses on the 
level of the pesticide residue in the processed food, measured on a 
weight to weight basis, compared to the level of the residue in the 
precursor raw agricultural commodity. If a processing study shows that 
the level of pesticide residue in the processed food exceeds the level 
of residue in the precursor raw agricultural commodity, EPA would 
conclude there has been a concentration in fact of the pesticide 
residues in the processed food.
    EPA believes the concentration in fact test is relevant to the 
inquiry of whether a section 409 FAR is needed because residues in the 
raw crop may be at or near the section 408 tolerance level. Residues in 
the raw crop may be close to the section 408 tolerance level because 
section 408 tolerance levels are established based on actual field 
trials and designed to be set no higher than necessary given approved 
usage directions for the pesticide established in the FIFRA 
registration. Under EPA regulations, the section 408 tolerance level 
should ``reasonably reflect the amount of residue likely to result when 
the pesticide chemical is used in the manner proposed.'' 40 CFR 180.4. 
If residue levels in the raw crop are at or near the section 408 
tolerance level and concentration in fact occurs during processing, the 
residue level in the processed food is likely to exceed the section 408 
tolerance. The National Academy of Sciences (NAS) has acknowledged the 
logic behind EPA's reliance on a concentration in fact standard:

    In determining whether a section 409 food additive tolerance is 
required, the EPA focuses on whether residues in any processed 
product exceed those found on the unprocessed crop, not whether 
residues concentrate above some hypothetical section 408 tolerance.
    The logic of the EPA's practice is clear. A section 408 
tolerance represents a residue level that may in some cases be 
realized. A section 409 tolerance must reflect the possible residue 
levels in processed foods derived from that raw commodity.

National Research Council, Regulating Pesticides in Food: Delaney 
Paradox 28 (1987).

III. The NFPA Petition

    On September 11, 1992, the National Food Processors Association 
(NFPA), the United Fresh Fruit and Vegetable Association, the Florida 
Fruit and Vegetable Association, the Northwest Horticultural Council, 
and the Western Growers Association filed a petition with EPA 
challenging the policies followed by EPA in linking its regulatory 
activities under the various pesticide provisions of FIFRA and FFDCA. 
(Petition to the Environmental Protection Agency, Office of Pesticide 
Programs, Concerning EPA's Pesticide Concentration Policy (1992)) 
(hereinafter cited as ``NFPA petition''). The NFPA petition explicitly 
attacks what it calls EPA's ``concentration policy.'' In actuality, the 
petition is a challenge to two interrelated policies described by EPA 
as its coordination and concentration policies. The NFPA petition 
argues that the coordination and concentration policies are both 
unlawful and unnecessary. The petition requests that the EPA 
coordination policy be repealed so that section 408 tolerances can 
remain in effect (or can be established) for pesticide uses even if, 
under the Les decision, the associated section 409 FARs have to be 
revoked (or cannot be established). The petition asks that the 
concentration policy be modified so that it takes into account factors 
beyond the concentration in fact test. Additionally, the petition 
requests that EPA apply the term ``ready to eat'' in the flow-through 
provision according to what NFPA asserts is its plain meaning.
    EPA sought public comment on the petition (58 FR 7470, Feb. 5, 
1993). Extensive public comment was received, and significant comments 
are discussed in this notice. Several more narrowly focused comments 
are discussed in a separate document that has been included in the 
docket.

IV. Summary of EPA's Partial Response to NFPA Petition

    Sections V through VII below set forth EPA's partial response to 
the NFPA petition. EPA has not reached a decision on NFPA's challenge 
to the coordination policy. EPA, however, has completed evaluation of 
NFPA's contentions regarding the concentration policy and EPA's 
interpretation of the term ``ready to eat.'' This document responds to 
the NFPA petition on these two issues. In brief, EPA agrees with NFPA 
and many of the commenters that modifications should be made to its 
concentration policy so that it is a better predictor of the likelihood 
that residues in processed food may exceed the applicable section 408 
tolerance. EPA, however, cannot accept all of NFPA's suggested changes 
to the concentration policy. As to interpretation of the phrase ``ready 
to eat,'' EPA agrees that such term must be given its common-sense 
meaning.

V. Concentration Policy

A. General Issues

    EPA's concentration policy is the trigger for when a pesticide use 
needs a section 409 FAR. EPA has treated a pesticide use as needing a 
section 409 FAR generally whenever a processing study shows that 
pesticide residues are greater in the processed food than in the raw 
agricultural commodity before processing. In other words, EPA looks to 
see if the pesticide ``concentrates in fact.'' EPA has used 
concentration in fact as the trigger for when a food additive 
regulation is needed because, in theory, RAC tolerances are set at 
levels no higher than necessary to cover maximum legal usage under the 
FIFRA registration. RAC tolerances are established based on field trial 
data showing the range of residues likely to result from maximum legal 
application of the pesticide. Generally, the RAC tolerance level is set 
just slightly above the maximum residue value found in the field 
trials. Thus, if concentration in fact occurs during processing, 
overtolerance residues in processed food can result if the RACs used 
for processing contain pesticide residues reflecting maximum legal 
usage.

[[Page 31303]]

    NFPA challenges EPA's concentration policy on two grounds. First, 
NFPA claims that all available data support the view that food additive 
regulations are unnecessary to avoid adulterated processed food. 
Second, NFPA argues that EPA has ignored the ``ready to eat'' 
requirement in the flow-through provision. EPA's interpretation of the 
term ``ready to eat'' will be addressed in the following section.

B. Monitoring Data and the Concentration Policy

    NFPA cites various data sources which it claims show residues on 
both raw and processed foods generally to be well below the level of 
the RAC tolerance. NFPA argues that residues in processed foods 
generally fall below RAC tolerances because of the careful attention 
paid to the flow-through provision by food processors.

    When the flow-through provision was adopted and as it operated 
for a number of years, processors clearly understood that it was 
their obligation to produce a processed product that stayed within 
the raw product tolerance. This obligation could be met through any 
number of steps, including supervision of growers' pesticide 
practices, careful and informed buying practices, analysis of raw 
product, handling, cleaning and treatment of the raw product, and 
testing of the finished produce to assure that it would be in 
compliance with the Act * * *. [T]hey recognized that if their 
process involved some degree of concentration [and the food is 
consumed in the concentrated form], they were well advised to use 
raw product that at the time of processing was below the prescribed 
tolerance levels, and that failure to take such steps could possibly 
result in adulteration and a costly enforcement action.

(Comments of NFPA at 37-38).
    NFPA asserts that the steps taken by processors to avoid 
overtolerance residues show that EPA's reliance on processing studies 
to require food additive regulations is unwarranted.
    The data relied upon by NFPA do show that pesticide residues in raw 
and processed food generally are below section 408 tolerance levels. On 
the other hand, EPA is often presented with processing studies by 
pesticide manufacturers that demonstrate that particular pesticides 
concentrate in processed food to levels 2 times, 10 times, or even 50 
times above the level found in the raw crop. EPA has examined carefully 
the factors cited by NFPA and commenters as an explanation for the low 
levels of residues to determine whether any adjustments to the 
concentration policy are appropriate. Although EPA has concluded that 
some adjustment to the concentration policy is warranted, EPA believes 
that the basic rationale of the concentration policy with its focus on 
concentration in fact is sound. As the National Academy of Sciences has 
found:
    The logic of EPA's practice is clear. A section 408 tolerance 
represents a residue level that may in some cases be realized. A 
section 409 tolerance must reflect the possible residue levels in 
processed foods derived from that commodity.

National Research Council, Regulating Pesticides in Food: Delaney 
Paradox 28 (1987)
    At the same time, EPA recognizes that reliance solely on processing 
studies may not, in some circumstances, accurately ``reflect the 
possible residue levels in processed foods.''
    In challenging the concentration policy, some commenters argue that 
EPA's policy is a theoretical exercise with no basis on actual data and 
that this is confirmed by EPA's description of its policy in its 
request for comment on the NFPA petition. EPA did not mean to suggest 
in that notice that its concentration policy focuses on theoretical 
possibilities. EPA's policy has always sought to determine whether 
residues greater than the section 408 tolerance can occur in processed 
food. EPA makes this determination based on hard data-- actual 
processing studies involving, in most cases, the pesticide and crop in 
question. EPA's revisions to its policy do not change the basic focus 
of the concentration policy. Rather, as explained below, EPA has 
expanded the range of data and other information it will consider in 
determining whether residues greater than the section 408 tolerance can 
occur in processed food.
    It is worth noting that the same data relied upon by NFPA to show 
that most food, whether raw or processed, is well below section 408 
tolerance levels also reinforces EPA's judgment that many section 408 
tolerances may currently be set higher than necessary and may need to 
be lowered so that they reasonably reflect actual residues. If section 
408 tolerances are lowered, the chances of residues over the section 
408 tolerance in processed foods where residues concentrate in fact 
would be greater.

C. Revisions to the Concentration Policy

    1. Introduction and summary. EPA's concentration policy is designed 
to evaluate when residues in processed food may exceed the raw food 
tolerance due to concentration during processing. Generally, in 
implementing its concentration policy, EPA has used a test of 
concentration in fact as an indicator that residues over the section 
408 tolerance may occur because residue levels in the RAC may exist at 
the tolerance level. EPA, however, also has historically considered, to 
a limited extent, at least two other factors in evaluating whether a 
processing study showing concentration of residues indicates there is a 
real possibility of residues over the section 408 tolerance. Below, EPA 
discusses those factors and other factors that may prevent the 
occurrence of residues over the section 408 tolerance.
    EPA concludes that it has too rigidly applied its concentration in 
fact test. EPA continues to believe that information from processing 
studies is generally the most important single piece of information is 
assessing the likelihood that residues in processed food could exceed 
the section 408 tolerance. EPA will also continue to consider factors 
such as the variability of the analytical method and the degree of 
rounding used in establishing the section 408 tolerance. In a departure 
from past practice, EPA will, as explained below, take into account, 
where appropriate, information pertaining to the averaging of residues 
during processing. EPA will also, where appropriate, consider 
information obtained from properly designed market basket surveys. EPA, 
however, is not convinced at this time by the NFPA suggestion that, 
despite data showing residues concentrate during processing, processors 
can insure residue levels stay below section 408 tolerance levels.
    2. Factors relied upon by EPA in determining whether a pesticide 
which concentrates in fact is likely to produce residues in exceedance 
of the section 408 tolerance. As noted, EPA follows a concentration in 
fact test to determine if section 409 FARs are necessary. For the most 
part, EPA's concentration in fact test is applied based on the results 
from data from processing studies. Historically, EPA has also 
occasionally considered two other factors in determining whether a 
processing study which shows concentration in fact does show that 
residues in processed food can exceed the appropriate section 408 
tolerance.
    The first of these factors is the degree of rounding that was used 
in setting the RAC tolerance. To a limited extent, EPA has considered 
the degree of rounding in past decisions on whether a section 409 FAR 
is needed. Generally, the highest value obtained from field trials is 
rounded up in selecting the tolerance level. For example, if the 
highest value from field trials was 8 parts per million (ppm), that 
data point might be rounded to 10 ppm for the tolerance value. Where 
rounding increases the observed residue level by 25 percent, the 
pesticide would have to concentrate by 

[[Page 31304]]
a factor of greater than 25 percent (1.25X) to produce residues over 
the section 408 tolerance.
    The second factor currently relied upon by EPA is the degree of 
variability in the analytical method used to measure residue levels in 
the field and processing studies and for enforcement of the tolerance. 
If residues do not concentrate to a greater degree than the variability 
in the methods, no residues over the section 408 tolerance could be 
reliably detected.
    3. Other factors potentially relevant to whether residues exceed 
the section 408 tolerance. In the past, EPA has generally not taken 
into consideration various other factors that may explain why, despite 
the fact that a processing study suggests there is a possibility of 
residues greater than the RAC tolerance, that event seems to occur 
infrequently. One factor that lessens the possibility of residues over 
the section 408 tolerance in processed food is that EPA's judgment 
concerning whether such residues could occur assumes that the pesticide 
will be used at the maximum label rate and applied the maximum number 
of times permitted, and that the crop will be harvested at the shortest 
preharvest interval allowed. Frequently, however, these maximum 
application and harvest practices are not followed resulting in 
residues far below tolerance levels in the raw crop, with 
correspondingly lower levels in the processed food.
    A second factor that serves to result in lower residue levels is 
that tolerance values are set to reflect the maximum residue level that 
could result from maximum legal application and harvest practices but 
field trials generally show a wide range of residue levels even when 
maximum legal application and harvest practices used in each trial. 
Thus, average residue values from such field trials tend generally to 
be significantly below the maximum residue level found in field trials 
and, thus, also significantly below the tolerance level.
    A third factor that may explain lower observed residues in 
processed foods is that the processing of many crops involves mixing or 
blending of large amounts of the raw crop. Oftentimes this can result 
in significant lowering of residue values as untreated crop is blended 
with treated crop. Further, this blending accentuates the above two 
factors as lightly treated crops are mixed with crops having received 
maximum treatment and high and low level residues from crops receiving 
maximum treatment are mixed.
    Another reason why residues over the section 408 tolerance may not 
occur in processed food is that pesticides often degrade significantly 
during the time in which the crop is transported and stored prior to 
processing. Thus, even if crops bearing tolerance level residues at 
harvest were the only ingredient used in food processing, any 
concentration of residues might be offset by normal degradation of 
residues.
    NFPA suggests additionally that the chance of residues over the 
section 408 tolerance is not great because of various steps taken by 
food processors. NFPA cites ``supervision of growers' pesticide 
practices, careful and informed buying practices, [and] analysis of raw 
product'' as actions which serve to reduce residues. Further, various 
commenters have contended that residues over the section 408 tolerance 
in some processed foods could be avoided by restrictions on pesticide 
use to crops grown for the fresh market.
    4. Evaluation of factors. Below, EPA evaluates its concentration 
policy including EPA's use of processing studies, the factors 
considered by EPA in evaluating whether processing studies show the 
possibility of residues over the section 408 tolerance, and the 
relevance of the various reasons noted above why overtolerance residues 
infrequently occur.
    Processing studies. EPA guidelines on residue data specify that 
processing studies should ``simulate commercial processing as closely 
as possible.'' Pesticide Assessment Guidelines, Subdivision O at 21 
(1982). Data from such studies, EPA believes, remain the most relevant 
information in determining whether residues over the section 408 
tolerance may occur. Because section 408 tolerance values represent a 
level of residues which field trial studies show can occur, data from a 
processing study showing concentration can be a good indicator 
regarding the possibility of overtolerance residues in processed food. 
EPA has not issued extensive industry-by-industry guidance on what 
constitutes ``commercial processing'' but rather has left it to the 
pesticide manufacturer to insure that modern commercial processing is 
reflected in the processing studies. Thus, EPA disagrees with comments 
by NFPA and other commenters which suggest it is EPA which is at fault 
for not taking into account practices such as washing and peeling that 
routinely occur during processing. If those practices are a part of 
commercial processing for certain foods and are not reflected in the 
processing studies designed and submitted by pesticide manufacturers, 
the pesticide manufacturers need to provide EPA with data that are 
truly representative of the industry practice.
    Rounding. To a limited extent, EPA has considered the rounding up 
that occurs in the selection of the section 408 tolerance value in 
making concentration determinations. EPA believes the degree of 
rounding remains a legitimate consideration in determining the 
likelihood that processing may produce residues in processed food 
greater than the section 408 tolerance. Moreover, as noted below, EPA 
believes it is appropriate to consider the difference between residue 
levels that can occur on crops and the section 408 tolerance level in 
evaluating the possibility of residues over the section 408 tolerance 
in processed food.
    But EPA is concerned that its past practice of rounding up has 
resulted in section 408 tolerances being set at a level higher than is 
necessary to cover legally treated crops. EPA is currently examining 
whether older section 408 tolerances have been set at inappropriately 
high levels owing to rounding or for other reasons. EPA is also 
exploring whether there might not be statistical techniques for better 
assigning section 408 tolerance levels. To the extent EPA alters its 
approach to selecting section 408 tolerance levels, these revised 
section 408 levels will need to be considered in making determinations 
under the concentration policy.
    Variability of methods. EPA continues to believe that the 
variability of the analytical method should be evaluated in determining 
whether residues over the section 408 tolerance are likely to be 
reliably detected despite a processing study showing concentration in 
fact. The aim of the concentration policy is to identify those uses 
which can produce residues over the section 408 tolerance in processed 
food. If any possible concentration is so low that it could not be 
clearly identified by the relevant analytical method, then, in fact, 
instances of residues over the section 408 tolerance in processed food 
would not be expected. The degree of variability in analytical methods 
must be assessed on a case-by-case basis. Generally, the variability in 
analytical methods suggests that residues over the section 408 
tolerance are not likely to be reliably detected where processing 
studies show concentration factors in the range of 1.1X to 1.5X.
    Treatment rates and processor control. EPA believes that it is 
appropriate to assume that some growers will treat a portion of their 
crop at the maximum treatment rate allowed by the label. EPA's 
experience has shown that due to unexpected weather 

[[Page 31305]]
and pest pressures it is unrealistic to assume that no grower will 
treat his or her crop with a pesticide in the manner that yields the 
highest lawful residues.
    Moreover, where residues do concentrate during processing, EPA 
questions the ability of the processor or grower to manage pesticide 
residue levels so as not to produce over-tolerance residues in 
processed food. Although processors may know the concentration factor 
of residues from processing studies, the concentration factor does not 
suggest with any precision how processors could instruct growers to 
change their pesticide application procedures so that residues over the 
section 408 tolerance will not result in processed food. Levels of 
residues in raw crops are dependent not only on how much pesticide is 
applied but on when and how the pesticide is applied. Little data exist 
that describe the effect of varying any of these procedures on residue 
levels. Similarly, EPA believes little information is available 
concerning how changes in their manufacturing processes affect residue 
levels in processed food. Finally, as discussed below, the comments 
received on the NFPA petition reinforce EPA's experience that farmers 
often do not know the ultimate destination of their crop. Therefore, 
EPA believes it would be very difficult for growers or processors to 
manipulate residue levels in processed food.
    EPA would be open to considering further industry proposals laying 
out a potential policy framework that more specifically delineates how 
processor practices could be taken into account in determining the 
likelihood that residues in processed food would exceed the applicable 
section 408 tolerance. It would be helpful if such policy proposals 
contained criteria for evaluating whether specific processor claims 
regarding pesticide/commodity combinations are reasonable. Among other 
things, these criteria should address (1) what data would be submitted 
to EPA to verify residue levels, (2) how the practicality of the 
proposed scheme would be evaluated (e.g., degree of concentration of 
processing operations and ability to separate raw food streams), and 
(3) whether processor control of residue levels for a specific 
pesticide/commodity combination could be feasibly enforced. If such 
further policy proposals are received, EPA would seek public input 
before making any decision on the merits of the proposals and using the 
proposed criteria in evaluating specific pesticide uses.
    Mixing and blending. EPA believes that in many instances it would 
be appropriate to take into account mixing and blending in determining 
the likelihood that residues over the section 408 tolerance could 
result. This change in practice is warranted, EPA believes, because 
EPA's prior assumption, i.e., that all raw food have the potential to 
have residues at or near the section 408 tolerance level, does not 
adequately take into account the realities of food processing. Because 
of the way EPA sets section 408 tolerances, individual raw commodities 
do have the potential of having residues at or near the tolerance 
level. The data from field residue trials show, however, that residue 
values even from a single field can vary significantly. When individual 
raw commodities are mixed in processing operations, it is realistic to 
expect that there will be an averaging effect on the residues in the 
processed food.
    Accordingly, if EPA determines that there is a sufficient degree of 
mixing or blending during processing such that the normal variation 
among individual samples from a field will be substantially evened out, 
EPA will consider comparing some ``average'' residue value from field 
trials times the concentration factor to the RAC tolerance level in 
determining the likelihood of residues over the section 408 tolerance. 
EPA generally believes that the most relevant ``average'' residue value 
from crop field trials is the highest average residue value from the 
series of individual field trials. Using an average of all samples from 
all field trials in all regions of the U.S. would tend to suppress the 
variability in residue values to a greater extent than can be expected 
by mixing or blending. Generally, crops grown in different regions of 
the U.S. are not mixed prior to processing. Rather, crops are often 
processed field-by-field as they are harvested by the grower.
    There are a number of constraints EPA thinks are critical here. 
First, considering average field trial residues is only appropriate 
where the values being averaged are from field trials involving maximum 
treatment rates. In other words, averaging may be used to take into 
account the variation in residues which occurs in crops receiving 
maximum treatment and minimum preharvest intervals but not residue 
variations as result of different levels of treatment. As laid out 
above, EPA has no basis on which to make assumptions about whether 
crops in specific instances would be treated at rates lower than the 
maximum permitted on the pesticide label or what residues those lower 
rates would produce. Second, whether considering blending would be 
appropriate would depend on the quality of the data base. Consideration 
of any ``average value'' would be less appropriate where adequate data 
from all representative regions of the country are not available. 
Finally, even where it would be appropriate to consider average 
residues, EPA believes a simple calculation showing that the average 
residue multiplied by the concentration factor from a processing study 
is less than the RAC tolerance alone may not conclusively show that 
residues over the section 408 tolerance could not result. In 
appropriate circumstances, EPA may need to consider a number of other 
factors, such as the variability in the field trial data, in 
determining the likelihood of residues over the section 408 tolerance.
    Degradation of residues. Although EPA recognizes that degradation 
of residues frequently occurs, it is not apparent how EPA could take 
that phenomenon into account in its concentration policy other than to 
the extent the effects of degradation are captured in processing 
studies. EPA would need detailed data on the degradation rates of 
pesticides as well as on the minimum time between the harvesting of 
crops and when such crops are manufactured into ready-to-eat processed 
foods. Without such information, it would be difficult to establish a 
tolerance level that would assure that legally treated crops did not 
result in illegal food.
    Some comments filed in response to the NFPA petition suggest that 
marketplace survey or FDA monitoring data would be relevant to whether 
there is a likelihood of residues over the section 408 tolerance. 
Certainly, data from marketplace studies have some degree of relevance 
to the question of whether residues in processed food may exceed the 
section 408 tolerance. The relevance of marketplace studies, however, 
depends on how the marketplace study was performed. For example, the 
principal reason marketplace studies have been conducted in the past is 
to obtain better data concerning actual residue values close to the 
point at which food is consumed. Thus, marketplace studies generally 
involve sampling commodities in retail grocery stores. A tolerance for 
processed food would not only apply to food in retail stores but at all 
prior points at which the food moved in interstate commerce. This fact 
would have to be taken into account in assessing the relevance of a 
marketplace study in determining the likelihood of residues in 
processed food in excess of the section 408 tolerance. Monitoring data 
can also be relevant to determining 

[[Page 31306]]
the likelihood of residues in processed food exceeding the section 408 
tolerance. However, FDA monitoring data, especially monitoring data on 
processed foods, generally has been limited and thus may not be a 
reliable predictor of the level of residues of a particular pesticide 
in a particular processed food.
    Market segregation. Several commenters contend that, even where 
residues could be expected to concentrate in processed food above the 
section 408 tolerance, if EPA were to permit pesticides to be labeled 
solely for crops grown for fresh market, no section 409 FAR would be 
needed for such pesticide uses. These commenters claim that certain 
crops are so specialized that they are grown specifically for the fresh 
or processed market, and, in some instances, that even different 
pesticides are used on crops depending on whether they are intended for 
the fresh or processed market. Thus, these commenters argue that 
allowing pesticides to be labeled for crops grown only for the fresh 
market where a specialized crop has been developed solely for the fresh 
market would not pose an enforcement problem. On the other hand, EPA 
received other comments stating that placing such label restrictions on 
pesticides would subject growers to a form of ``Russian Roulette.'' 
EPA's observations indicate that it is difficult to achieve total 
market segregation; however, if a party can show that a market for a 
specific crop can be segregated and that such segregation can be 
feasibly monitored, EPA will not require a section 409 FAR for a 
pesticide on that crop.
    5. Conclusion. In sum, EPA's concentration policy will continue to 
focus on ``possible residues'' in the processed food. EPA will place 
primary emphasis on whether processing studies show that the processing 
of a commodity results in a level of residues in the processed food 
which is greater than the level of residues in the raw food. EPA will 
also consider the variability of the analytical method, the degree of 
rounding involved in establishing the section 408 tolerance, and, where 
circumstances permit, information concerning blending of crops and 
average field trial values, and market basket surveys. EPA will 
consider information concerning potential market segregation and 
pesticide segregation, but such segregation must be established by 
clear evidence. But EPA remains unconvinced at this time that it should 
give much weight at all to degradation information or the possibility 
that farmers are applying pesticides at lower application rates or that 
processors will control whether residues over the section 408 tolerance 
occur.

VI. Ready To Eat

A. NFPA's Argument and Views of Commenters

     The NFPA petition argues that EPA has failed to take into account 
language in the flow-through provision of FFDCA section 402 specifying 
that processed food is to be evaluated at the ``ready-to-eat'' stage in 
determining whether the food exceeds the relevant section 408 
tolerance. According to NFPA, the ``ready to eat'' language was added 
to the statute to ``take care of any particular problem that might be 
raised with respect to a product that was concentrated or dehydrated.'' 
(NFPA Petition at 34). In its comments, NFPA proposed a definition of 
not ready-to-eat food as food ``customarily reconstituted by the 
consumer or food manufacturer, or [food] sold for use as an ingredient 
in the preparation of finished foods.'' (Comments of NFPA at 12). 
Further, NFPA cites several examples from the Code of Federal 
Regulations and the Federal Register in which Federal agencies have 
used the term ``ready to eat'' to distinguish between various foods.
    Except for two comments from State agencies (Florida Department of 
Agriculture and North Dakota Department of Agriculture), most of the 
commenters on the NFPA petition assert that EPA's approach of treating 
any food available for sale as ``ready to eat'' is violative of the 
plain words of the statute. Many of these commenters also contend that 
EPA overstated the enforcement difficulties of construing the term 
``ready to eat'' more narrowly.
    As to the definitional issue, numerous commenters contend that the 
literal or plain meaning of the term ``ready to eat'' food is food 
consumed ``as is.'' One commenter quotes the dictionary definitions of 
``ready'' and ``eat'' to derive a definition of ``ready to eat'' food 
as ``prepared for immediate taking through the mouth as food.'' 
(Comments of Catherine Clay at 1). Many commenters mention specific 
foods and assert that they were not consumed ``as is.'' In their 
comments, fruit growers are particularly adamant that juice 
concentrates are not ``ready to eat.'' (See, e.g., comments of Sun-
Diamond Growers at 7 (``People simply do not consume a quart of prune 
juice concentrate or even a cup of concentrate.'')). Another commenter 
contends that EPA should focus on what the usual practice was as to 
foods:

    We suggest that for those food items that are never or seldom 
consumed in their concentrated forms (e.g., tomato paste, oils, 
flour, and juice concentrates), Section 402 should be followed * * 
*. Those few situations in which product might be consumed in the 
concentrated form do not present an imminent hazard and will not add 
significantly to the risk calculation.

(Comments of Del Monte Foods at 1).
    As to potential enforcement difficulties with following a consumed 
``as is'' approach to ``ready to eat,'' several commenters argue that 
EPA could adopt action levels to determine if processed not ready-to-
eat food is adulterated. (Comments of Monsanto; Grocery Manufacturers 
Association; NFPA). Such action levels would be established using 
dilution factors that take into account the dilution of pesticide 
residues as a food is mixed with other foods in processing operations. 
The dilution factors, these commenters urge, should be based on the 
most concentrated form of ready-to-eat food that the not- ready-to-eat 
food was used to produce.
    Finally, several commenters claim that commodities such as fruit 
pomaces and seed hulls which are commonly used as animal feeds are not 
``ready to eat.'' According to these commenters, most animal feeds are 
a blend of different ingredients because commodities such as pomaces 
and hulls are both nutritionally deficient and unpalatable.

B. EPA's Response

    1. The definitional issue. EPA has considered NFPA's arguments and 
the comments received and has examined the previous uses of the term 
``ready to eat'' by EPA and other Federal agencies. EPA agrees that the 
term ``ready to eat'' food has a common-sense meaning of food which is 
consumed without further preparation. EPA intends to apply that 
interpretation in future actions. Basically, EPA believes that food 
should be considered ``ready to eat'' if it is consumed ``as is'' or is 
added to other ready-to-eat foods (e.g., condiments). Use of this 
interpretation, of course, will not clarify all issues regarding 
``ready to eat'' foods. EPA envisions that this definition may be 
difficult to apply in many instances.
    Some foods will be easier to classify than others. EPA has, in the 
past, established section 409 FARs for some foods that clearly do not 
meet a common-sense interpretation of ``ready to eat'', and EPA did so 
without closely considering what level of residue would occur in 
derivative foods which are ``ready to eat.'' Examples would include 
dried hops, mint oil, citrus oil, and guar 

[[Page 31307]]
gum. These foods are not generally available to consumers in grocery 
stores and, even if a consumer could purchase such a food, it would not 
be consumed ``as is'' but would be further processed (e.g., dried hops 
used in brewing beer) or used as an ingredient in a food product. Other 
foods for which EPA has set food additive regulations, such as raisins, 
olives, and potato chips, clearly are ``ready to eat.''
    EPA generally believes that foods that are mixed prior to 
consumption are not ``ready to eat.'' Mixing generally involves the 
combining of foods with the intent of creating a different food 
product. For example, combining a tea bag with hot water is intended to 
create a new food product, the beverage tea. Thus, the dried tea in the 
tea bag would not be considered ``ready to eat.'' On the other hand, 
EPA does not believe this mixing principle applies to condiments. 
Condiments are consumed as a supplement to other ``ready to eat'' food. 
A condiment is also consumed ``as is.''
    There remain, however, many commodities for which EPA has 
traditionally set food additive regulations which are not so easily 
characterized under the ``ready to eat'' standard and which will 
require a case-by-case inquiry. One of the reasons for the fact-
intensive nature of this inquiry is that foods have many uses and 
eating habits vary widely in the United States. Thus, determining 
whether a food is ``ready to eat'' involves identifying all significant 
uses of a food and then determining if any of those uses meets the 
definition of ``ready to eat.'' For example, perhaps the most common 
use of vegetable oil is as a cooking medium or as an ingredient in 
baked products. However, another use of vegetable oil is as a 
``dressing'' for a green salad. When used in this manner, oil is 
directly added to the salad as a condiment, and thus oil generally 
would qualify as ``ready to eat.'' Additionally, EPA will need to 
explore whether some foods which have traditionally not been consumed 
without further preparation, are actually being consumed on an ``as 
is'' basis. Comments submitted by DuPont Agricultural Products support 
this approach:

    We appreciate that some concentrated products can be consumed 
without mixing. The likelihood of occurrence of this consumption 
pattern is a factor which should be considered in determining which 
form is best viewed as the ready-to-eat stage. In our view, a 
reasonable approach would be to weigh such a consumption pattern 
based on the frequency of occurrence. If the consumption of the 
concentrate occurs with great infrequency, the appropriate ready-to-
eat food would still be the diluted product.

(Comments of DuPont Agricultural Products at 8).
    In circumstances where EPA's revised approach to the term ``ready 
to eat'' results in particular food forms of a commodity being dropped 
from the category of ``ready to eat,'' EPA will need to explore whether 
there is a possibility of concentration of residues above the section 
408 tolerance in any other, ready-to-eat forms of that commodity. In 
many instances further preparation of a not-ready-to-eat commodity will 
so significantly reduce residues that, even if the not-ready-to-eat 
precursor processed food contained residues over the section 408 
tolerance, the ready-to-eat commodity will not. Use of citrus oil as a 
flavoring in ice cream may be an example of this phenomenon. Citrus oil 
may be such a small proportion of the total product that any residues 
over the section 408 tolerance in the oil would be diluted below the 
section 408 tolerance in the ice cream. However, in other instances, 
the dilution involved in further preparation of a not-ready-to-eat 
processed food is not so dramatic. For example, flour, assuming it is 
found to be a not-ready-to-eat food, is prepared into commodities such 
as crackers or tortillas in which the dilution factor may be fairly 
modest. In situations such as this, EPA will have to determine whether 
it should be setting section 409 FARs on different commodities than has 
been EPA's traditional practice.
    2. Enforcement approach. EPA's revised approach to the term ``ready 
to eat'' will make enforcement of the FFDCA more challenging as regards 
foods no longer considered ``ready to eat.'' EPA does not view as 
satisfactory NFPA's suggestion that for enforcement purposes EPA should 
develop dilution tables and from such tables promulgate action levels 
to evaluate the legality of not-ready-to-eat processed food. Although 
this is a possibility, EPA regards it as cumbersome and lacking the 
enforcement ease of binding tolerances. An action level is not binding 
on anyone and thus even though use of a dilution table may suggest that 
a food is adulterated, FDA could only successfully proceed against the 
food if it could prove in court that the level of residue found in the 
not-ready-to-eat food would render ready-to-eat food adulterated.
    Instead, EPA has decided to use its general rule-writing authority 
under FFDCA section 701 to establish maximum residue levels for not-
ready-to-eat processed food. Section 701 grants EPA the authority ``to 
promulgate regulations for the efficient enforcement of this Act.'' 21 
U.S.C. 371. These maximum residue levels would be set no higher than 
the levels which could result in the processed food assuming legal 
residues in the raw food and that good manufacturing practices were 
followed.
    EPA's authority to set such maximum residue levels arises from the 
flow-through provision. The flow-through provision does not legalize 
residues in ready-to-eat processed food unless three criteria are met: 
(1) the residues are at or below the applicable section 408 tolerance; 
(2) the precursor raw food had residues within the section 408 
tolerance; and (3) good manufacturing practices were followed in 
preparing the processed food. The maximum residue levels set under 
section 701 would establish binding regulations as to when the two 
latter criteria of the flow-through provision are met for a specific 
pesticide use. If such a maximum residue level were exceeded in a 
processed food, then as a matter of law the flow-through provision 
would not apply to the food (whatever the residues in the food when it 
is ``ready to eat''), and thus the food would be adulterated as a 
matter of law under FFDCA section 402(a)(2)(C).
    3. Animal feeds. As noted, a number of commenters claimed that food 
processing byproducts such as grape pomace, soybean hulls, etc. are not 
``ready to eat'' either because they are unpalatable or nutritionally 
deficient or because they are not a significant portion of the diet of 
animals. EPA generally intends to apply a similar approach to 
processing byproducts used as animal feeds as it will to human foods in 
determining whether the byproducts are ``ready to eat'' and will also 
use section 701 maximum residue levels, as described above, where 
appropriate. Determinations on specific processing byproducts will have 
to be made on a case-by-case basis. To the extent it can be shown that 
any individual processing byproduct is unpalatable when fed ``as is'' 
or that for other reasons the processing byproduct is generally not fed 
absent further processing or mixing, EPA would not categorize that 
particular byproduct as ``ready to eat.'' EPA believes this showing 
probably can be made for a substantial number of processing byproducts.
    In response to comments stating that EPA required examination of 
processing byproducts not currently used as animal feeds (e.g., apple 
pomace), EPA would note that it has recently revised its guidelines on 
what processing byproducts are used as animal feeds. This revision 
followed a comprehensive survey of animal feed practices. EPA has 

[[Page 31308]]
also sought public comment on those guideline revisions and will 
continue to consider comments on this issue.
    4. Future actions. EPA intends to apply its revised approach to the 
term ``ready to eat'' in all future tolerance actions. When any action 
is taken based on EPA's revised approach, EPA will seek public comment 
on designations for specific commodities prior to making any final 
determinations.

VII. Are EPA's Policies Rules That Have Not Been Properly 
Promulagted?

    NFPA contends in its petition that EPA's coordination and 
concentration policies are not in compliance with the Administrative 
Procedure Act (APA) because they have not been promulgated as a binding 
regulation through notice and comment procedures. As to the 
concentration policy, EPA has in this notice announced a revised 
concentration policy that EPA believes is fully consistent with the 
requirements of the APA. This revised policy is not intended to be of 
controlling effect either on EPA or regulated parties. Rather, it is 
intended as guidance for EPA in administering its authority under 
FFDCA. For example, EPA has explained in some detail in its revised 
concentration policy what types of data it intends to place primary 
reliance upon in determining whether section 409 FARs are needed. 
However, EPA has noted its willingness to consider other information 
and arguments. Thus, because the revised concentration policy is not 
intended as a binding regulation, it need not be promulgated through 
notice and comment rulemaking.

List of Subjects

    Environmental protection, Agricultural commodities, Food additives, 
Feed additives, Pesticides and pests.

    Dated: June 9, 1995.

Lynn R. Goldman,
Assistant Administrator for Prevention, Pesticides and Toxic 
Substances.

[FR Doc. 95-14683 Filed 6-12-95; 12:20 pm]
BILLING CODE 6560-50-F