UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WAS HIN GTO N

, D. C

. 20460

OFFICE O F
CHE M IC A L S AFETY A ND
POLLUTIO N PREVENTIO N

MEMORANDUM

Date:

Subject:

From:

Through:

To: July 9, 2014

Processed Commodity Crop Group Position Paper

DonnaS. Davis, Co

- Chair

# ~~~~ Chemistry Science Advisory Council

Health Effects Division ( 7 509P)

Dana Vogel, Acting Division Director

Health Effects Division ( 7 509P)

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.

Pagelof5Page 2 of 5 Processed Commodity Crop Group Position Paper

Introduction Current regulation requires that when a crop gr oup 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, individua l processed commodity tolerances for that processed fraction are required fo r 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 appropria te to set crop group tolerances on processed commodities and codified that finding unde r 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 pro cessed 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 th e last sentence that is highlighted above.

Since 1983, the Agency has reviewed consid erable data on processing and processed commodities and has undertaken a comprehensive update of the crop groups established in the 40CFR. Additionally, the landscape with re spect 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 pr ocessed 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 rep resentative commodity sh ows that a pesticide concentrates in a processed fraction, a sing le 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 th at 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.Page 3 of 5 The Agency’s proposal would mean that for the example cited above , instead of multiple separate processed commodity tole rances for “barley, bran”; “wheat , bran”; and “rice, bran”; a single tolerance on “Gra in, cereal, group 15, bran ” would be set.

Supporting Rationale The Agency has considered the current practic es with respect to processed commodities, the current data requirements to support the esta blishment of an indivi dual processed commodity tolerance, information on how tolerances for pr ocessed commodities are set, and the research

that has arisen from th e crop group reevaluation.

The Agency has recently undertak en 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 consid er 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 consider ation 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 wo rk that is under way, the Ag ency has reconsidered the previously stated position on processed commod ity crop group tolerances and believes it is appropriate to permit the establishment of cr op group tolerances for th e following reasons:

 Crops are divided into crop groups based on consideration of crop type (e.g., cereal grains, stone fruits, etc.), horticultural pr actices (e.g., row crop s, 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, pestic ide use, and residue profile. Given these similarities, processed commodities are also likely to be comparable within a crop group and the commercial practice to pr oduce 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 deliberati ons, 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 de tailed discussion of the crop group review process, as well as several examples of th e information considered for two recent crop group revisions is attach ed to this document.

 Agency policy dictates that for a given pe sticide, a crop group tolerance will only be established when it is deemed appropriate to do so (i.e., the residue s from field trials do not differ by more than approximately 5X between the representative commodities for that group). Once the determination ha s 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 characteri stics of commodities within a crop group and the similar commercial practices fo r deriving processed commodities for crops within that group, it is reas onable to expect that pro cessed fractions from thePage 4 of 5 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 fr om crop field trials. To be considered valid, a processing factor must be base d 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 ar e conducted using the maximum application rate, the maximum number of applicati ons, the minimum retreatment interval between applications, and the minimum pre-harvest in terval. The highest residue level, based on per-site averages is multiplie d by the processing factor to determine the anticipated residue level in that proce ssed commodity. The anticipated residue is then rounded up to obtain the to lerance level for that par ticular pesticide/processed commodity combination. Given the inputs for deriving tolerances for residues in processed commodities, the resulting regulator y levels are inherently conservative. As such, residues in processed commodities from non-representative crops within a group are unlikely to exceed tolerances base d on residues in processed representative commodities. In reality, pesticides are not of ten 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 magn itude (10X to 100X lower). Therefore the Agency believes that the potential vari ability between crop group member processed commodity residues is compensated by the highly conservative manner in which processed commodity tolerances are set. This conclusion is s upported by findings in the PDP monitoring data which also show that actual residues in process fractions are considerably lower than established tolera nces for those processed commodities.

 Whether individual processed commodity to lerances are established, or a single processed commodity crop group commodity tolerance is established, the Agency will use the same underlying residue chemis try 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 wh eat processing data to other cereal grains; translation of orange processing data to othe r citrus fruits; translation of pome fruit processing data to other pome fruits; and transl ation of mint oil data to a ll 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 indivi dual processed commodity tolerances would be established. The Agency pr oposal would allow use of these wheat processing data in an identical manner; but instead of establishing tolerances for each individual processed comm odity, a single processed commodity crop group tolerance

would be established.

 The proposal to establish crop group tole rances for processed commodities has no impact on the human health risk assessments conducted by the Agency. Currently,Page 5 of 5 processing factors from representative comm odities 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” tole rance for processed fractions. There are currently 42 active ingredient s listed in the 40CFR §180 with a tolerance for “citrus, oil” (versus orange, oil; le mon, oil; lime, oil; etc.)

 This proposal will clarify the boundaries ar ound processed commodity tolerances by tying them to specifically defined crop gr oups. In the example cited above, the Agency would propose to establish a tolera nce 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 gr oup processed commodity tolerance.

 The ability to set crop group or subgroup pr ocessed 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) ha ve the authority to establish crop group tolerances for processed commodities. Gi ven the amount of collaboration the Agency has undertaken with PMRA, harmonization of tolerances is a high priority for the Agency.