UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF 

CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

MEMORANDUM 

Date: 

Subject: 

From: 

Through: 

To: 

July 9, 2014 

Processed Commodity Crop Group Position Paper 

Chemistry 

DonnaS. Davis, 

Science 

Co

Advisory 

-Chair 

Council 

~~~~ 

Health Effects Division (7509P) 

Dana Vogel, Acting Division Director 

Health Effects Division (7509P) 

Laura Nallen, Biologist 

Minor Use Team 

Risk Integration, Minor Use, Emergency Response Branch 

Registration Division (7505P) 

Attached please find the processed commodity crop group position paper developed by the 

Health Effects Division. 

Pagelof5 
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Processed Commodity Crop Group Position Paper 

Introduction 

Current regulation requires that when a crop group tolerance is established for a specific 

pesticide on a crop group and residues of that pesticide concentrate in a processed fraction 

common to multiple crop group members, individual processed commodity tolerances for that 

processed fraction are required for each member of that crop group. For example, if a crop 

group tolerance is set for Crop Group 15, the Cereal Grains Group and concentration is noted in 

bran in the processing studies submitted on the representative commodities, then the current 

regulations would require that we establish separate tolerances for “barley, bran”; “wheat, bran”; 

and “rice, bran.” 

Background 

In 1983, the Agency underwent a major expansion of the crop group regulations. At that 

time, the Agency opined that it was not appropriate to set crop group tolerances on processed 

commodities and codified that finding under 40 CFR180.40(f), which reads as follows: 

When the crop grouping contains commodities or byproducts that are utilized for animal 

feed, any needed tolerance or exemption from a tolerance for the pesticide in meat, milk, 

poultry and/or eggs must be established before a tolerance will be granted for the group as 

a whole. The representative crops include all crops in the group that could be processed 

such that residues may concentrate in processed food and/or feed. Processing data will be 

required prior to establishment of a group tolerance. Tolerances will not be granted on a 

group basis as to processed foods prepared from crops covered by the group tolerance.

 While the Agency is recommending various changes to the language in Section 180.40(f) 

at this time, this document only addresses the last sentence that is highlighted above. 

 Since 1983, the Agency has reviewed considerable data on processing and processed 

commodities and has undertaken a comprehensive update of the crop groups established in the 

40CFR. Additionally, the landscape with respect to processed commodities has changed 

markedly with, amongst other things, the removal of the Delaney Clause. In light of all the 

available data on crop groupings and processed commodities, the Agency believes that it is 

appropriate to reconsider the 1983 opinion on processed commodity crop group tolerances. 

Agency Proposal 

The Agency is proposing that when a crop group or subgroup tolerance is 

established, and processing data for the representative commodity shows that a pesticide 

concentrates in a processed fraction, a single processed commodity tolerance for that 

processed fraction should be established for the entire crop group or crop subgroup. To 

permit this, the Agency is recommending that the last sentence in 180.40(f) be removed 

from the 40CFR. Further, it is the Agency’s position that this is appropriate not only for 

processed commodities that are currently defined in the OCSPP Harmonized Test 

Guidelines 860.1000 Table 1, but for all processed commodities. 
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The Agency’s proposal would mean that for the example cited above, instead of multiple 

separate processed commodity tolerances for “barley, bran”; “wheat, bran”; and “rice, bran”; a 

single tolerance on “Grain, cereal, group 15, bran” would be set. 

Supporting Rationale 

The Agency has considered the current practices with respect to processed commodities, 

the current data requirements to support the establishment of an individual processed commodity 

tolerance, information on how tolerances for processed commodities are set, and the research 

that has arisen from the crop group reevaluation. 

The Agency has recently undertaken a review of the current crop groups in light of being 

made aware of many minor crops that were not specifically included in the original crop group 

listing. Working with the Interregional Project 4 (IR-4), the Agency began a process to 

systematically review crop groups and to consider if new raw agricultural commodities (RACs) 

should be added to the current groups, and also to determine if any of the crop groups lent 

themselves to a further division into subgroups. This is an ongoing and comprehensive look at 

crop groups, which also includes careful consideration of the processed commodities associated 

with that crop group or subgroup. Note that for the remainder of this document, the term crop 

group also refers to subgroup. 

In light of the crop group work that is under way, the Agency has reconsidered the 

previously stated position on processed commodity crop group tolerances and believes it is 

appropriate to permit the establishment of crop group tolerances for the following reasons: 

 Crops are divided into crop groups based on consideration of crop type (e.g., cereal 

grains, stone fruits, etc.), horticultural practices (e.g., row crops, orchard crops), 

commodity characteristics (e.g., smooth skin vs. fuzzy skin; edible peel vs. inedible 

peel) and growing regions/pest pressures. Therefore crops in a single crop group are 

likely to be very similar in form, pesticide use, and residue profile. Given these 

similarities, processed commodities are also likely to be comparable within a crop 

group and the commercial practice to produce the same processed fraction would 

likely to be similar for any member of that group. Further, processed fractions for a 

group are part of the crop group deliberations, and representative commodities for a 

crop group are selected with care to provide not only representativeness for the RAC 

but also for any processed fractions. A detailed discussion of the crop group review 

process, as well as several examples of the information considered for two recent crop 

group revisions is attached to this document. 

 Agency policy dictates that for a given pesticide, a crop group tolerance will only be 

established when it is deemed appropriate to do so (i.e., the residues from field trials 

do not differ by more than approximately 5X between the representative commodities 

for that group). Once the determination has been made that a crop group tolerance is 

appropriate and that similar pesticide residue levels are expected for all members of 

that group, then, given the similar characteristics of commodities within a crop group 

and the similar commercial practices for deriving processed commodities for crops 

within that group, it is reasonable to expect that processed fractions from the 
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representative commodities will be adequately representative of the same processed 

fractions for all members of the crop group. 

 The current process for setting processed commodity tolerances uses empirically 

derived processing factors and residue data from crop field trials. To be considered 

valid, a processing factor must be based on quantifiable residues in the raw 

commodity. The residues resulting from crop field trials are considered to be at 

worst-case levels because the trials are conducted using the maximum application 

rate, the maximum number of applications, the minimum retreatment interval 

between applications, and the minimum pre-harvest interval. The highest residue 

level, based on per-site averages is multiplied by the processing factor to determine 

the anticipated residue level in that processed commodity. The anticipated residue is 

then rounded up to obtain the tolerance level for that particular pesticide/processed 

commodity combination. Given the inputs for deriving tolerances for residues in 

processed commodities, the resulting regulatory levels are inherently conservative. 

As such, residues in processed commodities from non-representative crops within a 

group are unlikely to exceed tolerances based on residues in processed representative 

commodities. In reality, pesticides are not often used in a manner likely to lead to the 

maximum possible. USDA Pesticide Data Program (PDP) monitoring data shows 

that actual pesticide residue levels in RACs are considerably lower than the 

tolerances, often one to two orders of magnitude (10X to 100X lower). Therefore the 

Agency believes that the potential variability between crop group member processed 

commodity residues is compensated by the highly conservative manner in which 

processed commodity tolerances are set. This conclusion is supported by findings in 

the PDP monitoring data which also show that actual residues in process fractions are 

considerably lower than established tolerances for those processed commodities. 

 Whether individual processed commodity tolerances are established, or a single 

processed commodity crop group commodity tolerance is established, the Agency 

will use the same underlying residue chemistry data to determine the appropriate 

tolerance level. Current policy allows for the translation of residue chemistry 

processing data from one commodity to other commodities in the same crop group; 

for example, translation of wheat processing data to other cereal grains; translation of 

orange processing data to other citrus fruits; translation of pome fruit processing data 

to other pome fruits; and translation of mint oil data to all types of mint and various 

herb oils. Using the example cited above, residue chemistry data for wheat are 

required to support a crop group 15 tolerance. If concentration in processed fractions 

was identified in the wheat processing study, these data would then be translated to 

other members of the crop group and individual processed commodity tolerances 

would be established. The Agency proposal would allow use of these wheat 

processing data in an identical manner; but instead of establishing tolerances for each 

individual processed commodity, a single processed commodity crop group tolerance 

would be established. 

 

 The proposal to establish crop group tolerances for processed commodities has no 

impact on the human health risk assessments conducted by the Agency. Currently, 
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processing factors from representative commodities are translated to other processed 

commodities within the crop group as part of the dietary risk assessment process. 

 There is precedent for setting a “group” tolerance for processed fractions. There are 

currently 42 active ingredients listed in the 40CFR §180 with a tolerance for “citrus, 

oil” (versus orange, oil; lemon, oil; lime, oil; etc.) 

 This proposal will clarify the boundaries around processed commodity tolerances by 

tying them to specifically defined crop groups. In the example cited above, the 

Agency would propose to establish a tolerance on “Grain, cereal, group 15, bran” not 

“cereal grain, bran”. The association with the crop group will clearly define what 

commodities are included under the crop group processed commodity tolerance. 

 The ability to set crop group or subgroup processed commodity tolerances adds an 

efficiency to the Agency tolerance setting process. It streamlines the listing in the 

40CFR for specific tolerances. Further, it allows for a more internationally 

harmonized approach to tolerance setting as our colleagues in the Canadian Pest 

Management Regulatory Agency (PMRA) have the authority to establish crop group 

tolerances for processed commodities. Given the amount of collaboration the Agency 

has undertaken with PMRA, harmonization of tolerances is a high priority for the 

Agency.