Availability of Risk Management Analysis for the Importation of Clementines From Spain

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Notice of availability and request for comments.

SUMMARY:

We are advising the public that a risk management analysis has been prepared by the Animal and Plant Health Inspection Service relative to a proposed rule currently under consideration that would allow the importation of clementines from Spain to resume. We are making this risk management analysis available to the public for review and comment.

DATES:

We will consider all comments we receive that are postmarked, delivered, or e-mailed by May 16, 2002.

ADDRESSES:

You may submit comments by postal mail/commercial delivery or by e-mail. If you use postal mail/commercial delivery, please send four copies of your comment (an original and three copies) to: Docket No. 02-023-1, Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state that your comment refers to Docket No. 02-023-1. If you use e-mail, address your comment to regulations@aphis.usda.gov. Your comment must be contained in the body of your message; do not send attached files. Please include your name and address in your message and “Docket No. 02-023-1” on the subject line.

You may read any comments that we receive on the risk management analysis in our reading room. The reading room is located in room 1141 of the USDA South Building, 14th Street and Independence Avenue SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call (202) 690-2817 before coming.

APHIS documents published in the Federal Register, and related information, including the names of organizations and individuals who have commented on APHIS dockets, are available on the Internet at http://www.aphis,usda.gov/ppd/rad/webrepor.html.

FOR FURTHER INFORMATION CONTACT:

Dr. Ron A. Sequeira, Center for Plant Health Science and Technology, PPQ, APHIS, 1017 Main Campus Drive, Suite 2500, Raleigh, NC 27606-5202; (919) 513-2663.

SUPPLEMENTARY INFORMATION:

Background

The Animal and Plant Health Inspection Service (APHIS) is considering amending the fruits and vegetables regulations to allow the importation of clementines from Spain to resume. Until recently, APHIS allowed the importation of clementines from Spain under permit, provided that they were cold treated for the Mediterranean fruit fly (Ceratitis capitata) (Medfly) in accordance with the Plant Protection and Quarantine (PPQ) Treatment Manual, which is incorporated by reference into the regulations at 7 CFR 300.1.

In December 2002, APHIS suspended the importation of clementines from Spain due to interceptions of live Medfly larvae in clementines imported from Spain. Since that time, APHIS has conducted reviews of the clementine import program and of our Medfly cold treatment protocol in general. APHIS believes, based on the available evidence, that there are two possible explanations for the survival of Medfly larvae in imported Spanish clementines during the 2001-2002 shipping season. One is that despite the assumed mortality rate of Medflies following the cold treatment (99.9968 percent), any small or partial failure in the application of the cold treatment could have allowed Medflies to survive in clementines imported from Spain due to the above average levels of Medfly infestation of fruits. Alternately, it is possible that the level of Medfly infestation in imported clementines simply overwhelmed the capabilities of the cold treatment process, even if the treatment was properly applied.

At the request of the Government of Spain, APHIS has considered alternate strategies to mitigate the risk posed by Medflies imported in clementines from Spain. Our evaluation of proposed management measures is documented in a pest risk management analysis, “Risk mitigation for tephritid fruit flies with special emphasis on risk reduction for commercial imports of clementines (several varieties of Citrus reticulata) from Spain” (March 2002).

The risk management analysis uses an adaptation of a type of risk management approach used by the U.S. Food and Drug and Drug Administration (FDA) and U.S. Department of Agriculture's Food Safety and Inspection Service, called a hazard analysis and critical control point (HACCP) analysis.

HACCP analyses have been found to provide an effective and rational means of assuring food safety from harvest to consumption. Preventing problems from occurring is the paramount goal underlying any HACCP system, and seven basic principles are employed in the development of HACCP plans that meet the stated goal. These principles include hazard analysis, critical control point identification, establishment of critical limits, procedures for monitoring, corrective actions, verification procedures, and recordkeeping and documentation. Using a HAACP approach, if a deviation occurs indicating that control has been lost, the deviation is detected and appropriate steps are taken to reestablish control in a timely manner to ensure that potentially hazardous products do not reach the consumer.

APHIS has adapted the HAACP approach to apply to the analysis of phytosanitary measures. To distinguish our adaptation from the guidelines applicable to food safety, we use the name phytosanitary hazard analysis and critical control point (PHAACP). Using the PHACCP approach, the risk management analysis evaluates the risk reduction potential of phytosanitary measures employed to reduce the risk that clementines imported from Spain could be infested with Medflies. The PHAACP approach is described in generic form in an appendix to the risk management analysis.

The risk management analysis and appendices are available in our reading room (information on the location and hours of the reading room is listed under the heading ADDRESSES at the beginning of this notice) and on the Internet at http://www.aphis.usda.gov/oa/clementine/index.html. You may also request a copy by contacting the person listed under FOR FURTHER INFORMATION CONTACT.

This notice solicits public comments on the risk management analysis. We will also be making the risk management analysis available for public comment again during the comment period for any proposed rule related to the importation of clementines from Spain.

Authority: 7 U.S.C. 166, 450, 7701-7772; 21 U.S.C. 136 and 136a; 7 CFR 2.22, 2.80, and 371.3.