APHIS Issues Final Rule Amending its Phytosanitary Treatment Regulations

Among other things, the final rule: (i) removes the lists of approved treatments and treatment schedules from 7 CFR Part 305 in order to integrate them into APHIS' Plant Protection and Quarantine (PPQ) Treatment Manual; (ii) establishes a new process to provide the public with notice and the opportunity to comment on changes to treatment schedules; and (iii) harmonizes and combines the requirements for performing irradiation treatment for imported articles, articles moved interstate from Hawaii and U.S. territories, and articles moved interstate from an area quarantined for fruit flies.

Final Rule Similar to Proposed Rule, With Certain Changes

According to APHIS, the final rule is very similar to the proposed rule, with certain changes.

Highlights of APHIS Remarks, Comments Received

APHIS received 14 comments on its proposed rule. Highlights of APHIS' responses to those comments as well as statements that were not in response to any specific comment include the following (partial list):

Final Rule Does Not Alter Current Treatment Requirements or Their Use

The final rule does not alter current treatment requirements, the manner in which new treatments are evaluated, or when and how treatments are ultimately used, other than in emergency situations.

Expedites Treatment Schedule Amendments, Simplifies Presentation, Etc.

APHIS states that these changes will simplify and expedite APHIS' processes for adding, changing, and removing treatment schedules while continuing to provide for public participation in the process. They will also simplify APHIS' presentation of treatments by consolidating them into one document and eliminating redundant text from the regulations.

Phytosanitary Certificates for Imported Articles

Requirements that phytosanitary certificates accompany imported articles are typically contained in APHIS permits or in the regulations in 7 CFR part 319, which contains requirements for importing various articles. Therefore, APHIS has determined it is not necessary to include (as it had discussed in the proposed rule) a separate phytosanitary certificate requirement for treated articles in 7 CFR Part 305, especially when there would be many exceptions to that requirement.

Irradiation Treatment Work Plan Needed for All Facilities Treating Imports

APHIS had proposed to change the irradiation treatment framework equivalency work plan (FEWP) requirement so that it only applied to facilities located outside the U.S. However, upon further considering the purpose of the FEWP, APHIS has determined that the FEWP should continue to be required for all facilities treating imported articles, whether located outside or inside the U.S, as the equivalence principle applies regardless of where imported articles are treated.

Packaging Labeling

The final rule specifies that packaging must be labeled in a manner that "allows an inspector to determine" treatment lot numbers, packing and treatment facility identification and location, and dates of packing and treatment. APHIS states that this ensures that the information necessary to conduct traceback is available, while allowing flexibility in providing that information. APHIS adds that this level of detail is not necessary to include in the regulations as it already exists in the draft operational work plans.

Highlights of Final Rule

The following are highlights of the final rule:

Establishes Notice-Based Process for Amending Treatment Schedules

The final rule establishes a new notice-based process for adding, revising, or removing treatment schedules. There are two procedures, one for "normal" circumstances and another for instances requiring immediate action:

Normal circumstances. Under normal circumstances, APHIS will publish a notice requesting comments in the Federal Register describing the reasons it has determined it necessary to add, revise, or remove a treatment schedule. If the comments received support the action or did not otherwise change APHIS' determinations, it would issue a final notice.

Immediate action. In instances requiring immediate action (e.g., an approved treatment schedule is ineffective at neutralizing the targeted plant pest), APHIS may immediately add a new treatment schedule to the PPQ Manual and later publish a Federal Register notice describing why the action was necessary and seeking comments.

Relocates List of Approved Treatments/Schedules to PPQ Manual

The final rule amends the phytosanitary treatment regulations in 7 CFR Part 305 by removing the lists of approved treatments and treatment schedules from the regulations, while retaining the general requirements for performing treatments and certifying or approving treatment facilities. The final rule also removes treatment schedules from other places where they are currently found in 7 CFR Chapter III.

Approved treatment schedules will instead be located in APHIS' PPQ Manual which is available at http://www.aphis.usda.gov/import_export/plants/manuals/ports/treatment.shtml.

Harmonizes & Combines Irradiation Treatment Requirements

The final rule harmonizes and combines into one subpart (7 CFR 305.9) its requirements for performing irradiation treatment, as they were generally similar. These include the requirements for performing irradiation treatment for imported articles (previously 7 CFR 305.31); for regulated articles moved interstate from Hawaii and U.S. territories (previously 7 CFR 305.34); and for regulated articles moved interstate from an area quarantined for fruit flies (previously 7 CFR 305.32).

(See ITT's Online Archives or 05/14/09 news, 09051435, for BP summary of the proposed rule.)

APHIS contact - Inder Gadh (301) 734-0627

APHIS final rule (D/N APHIS-2008-0022, FR Pub 01/26/10) available at http://edocket.access.gpo.gov/2010/pdf/2010-1375.pdf