PART 353—EXPORT CERTIFICATION Authority: 7 U.S.C. 7701-7772 and 7781-7786; 21 U.S.C. 136 and 136a; 7 CFR 2.22, 2.80, and 371.3. Source: 61 FR 15368, Apr. 8, 1996, unless otherwise noted. § 353.1 Definitions. Administrator. Agent. Animal and Plant Health Inspection Service Consignment. Export certificate for processed plant products. Family. Industry-issued certificate. Inspector. Non-government facility. Office of inspection. Phytosanitary certificate. Phytosanitary certificate for reexport. Plant pests. Plant products. Plants and plant products. Reference Manual A. Reference Manual for Administration, Procedures, and Policies of the National Seed Health System, http://www.aphis.usda.gov/ppq/pim/accreditation. Reference Manual B. Reference Manual for Seed Health Testing and Phytosanitary Field Inspection Methods, http://www.aphis.usda.gov/ppq/pim/accreditation. State. The Act. [61 FR 15368, Apr. 8, 1996, as amended at 64 FR 1105, Jan. 8, 1999; 64 FR 72264, Dec. 27, 1999; 65 FR 50131, Aug. 17, 2000; 66 FR 21059, Apr. 27, 2001; 66 FR 37116, July 17, 2001; 66 FR 37400, July 18, 2001; 67 FR 8466, Feb. 25, 2002; 72 FR 35917, July 2, 2007; 81 FR 40151, June 21, 2016] § 353.2 Purpose and administration. The export certification program does not require certification of any exports, but does provide certification of plants and plant products as a service to exporters. After assessing the phytosanitary condition of the plants or plant products intended for export, relative to the receiving country's regulations, an inspector issues an internationally recognized phytosanitary certificate, a phytosanitary certificate for reexport, or an export certificate for processed plant products if warranted. APHIS also enters into written agreements with industry to allow the issuance of industry-issued certificates giving assurance that a plant product has been handled, processed, or inspected in a manner required by a foreign government. An industry-issued certificate includes an ISPM 15 quality/treatment mark. [61 FR 15368, Apr. 8, 1996, as amended at 64 FR 72264, Dec. 27, 1999; 72 FR 35917, July 2, 2007; 81 FR 40151, June 21, 2016] § 353.3 Where service is offered. (a) Information concerning the location of inspectors who may issue certificates for plants and plant products may be obtained by contacting one of the following regional offices: Region States Northeastern, Blason II, 1st Floor, 505 South Lenola Road, Moorestown, NJ 08057 CT, ME, MA, NH, RI, VT, NY, NJ, PA, MD, DE, VA, WI, MN, IL, IN, OH, MI, WV. Southeastern, 3505 25th Avenue, Building 1, North, Gulfport, MS 39501 FL, AL, GA, KY, MS, TN, NC, SC, PR, US VI. Central, 3505 Boca Chica Blvd., Suite 360, Brownsville, TX 78521-4065 TX, OK, NE, AR, KS, LA, IA, MO, ND, SD. Western, 9580 Micron Avenue, Suite I, Sacramento, CA 95827 HI, CA, CO, ID, MT, UT, WY, WA, OR, NV, NM, AZ, AK. (b) Inspectors who may issue phytosanitary certificates for terrestrial plants listed in 50 CFR part 17 or 23 are available only at a port designated for export in 50 CFR part 24, or at a nondesignated port if allowed by the U.S. Department of the Interior pursuant to section 9 of the Endangered Species Act of 1973, as amended (16 U.S.C. 1538). The following locations are designated in 50 CFR part 24 as ports for export of terrestrial plants listed in 50 CFR part 17 or 23: (1) Any terrestrial plant listed in 50 CFR part 17 or 23: Nogales, AZ Los Angeles, CA San Diego, CA San Francisco, CA Miami, FL Orlando, FL Honolulu, HI New Orleans, LA Hoboken, NJ (Port of New York) Jamaica, NY San Juan, PR Brownsville, TX El Paso, TX Houston, TX Laredo, TX Seattle, WA (2) Any plant of the family Orchidaceae (orchids) listed in 50 CFR part 17 or 23: Hilo, HI Chicago, IL (3) Roots of American ginseng ( Panax quinquefolius Atlanta, GA Chicago, IL Baltimore, MD St. Louis, MO Milwaukee, WI (4) Any plant listed in 50 CFR 17.12 or 23.23 and offered for exportation to Canada: Detroit, MI Buffalo, NY Rouses Point, NY Blaine, WA (5) Any logs and lumber from trees listed in 50 CFR 17.12 or 23.23: Mobile, AL Savannah, GA Baltimore, MD Gulfport, MS Wilmington and Morehead City, NC Portland, OR Philadelphia, PA Charleston, SC Norfolk, VA Vancouver, WA (6) Plants of the species Dionaea muscipula Wilmington, NC § 353.4 Products covered. Plants and plant products when offered for export or re-export. § 353.5 Application for certification. (a) To request the services of an inspector, a written application (PPQ Form 572) shall be made as far in advance as possible, and shall be filed in the office of inspection at the port of certification. Forms will be submitted using a U.S. Government electronic information exchange system or other authorized method. (b) Each application shall be deemed filed when delivered to the proper office of inspection. When an application is filed, a record showing the date and time of filing shall be made in such office. (c) Only one application for any consignment shall be accepted, and only one certificate for any consignment shall be issued. (Approved by the Office of Management and Budget under control number 0579-0052) [61 FR 15368, Apr. 8, 1996, as amended at 64 FR 72264, Dec. 27, 1999; 72 FR 35917, July 2, 2007; 81 FR 40151, June 21, 2016] § 353.6 Inspection. Inspections shall be performed by agents, by inspectors, or by employees of a State plant protection agency who are authorized by the agency to perform field inspections in accordance with this part and who have successfully completed training in accordance with paragraph (a)(2)(iii) of this section. Employees of a State plant protection agency who are not agents may perform field inspections only under the supervision of an inspector. (a) Agent. (2) To be eligible for designation as an agent, an individual must: (i) Have the ability to recognize, in the crops he or she is responsible for inspecting, plant pests, including symptoms and/or signs of disease-causing organisms, of concern to importing countries. (ii) Have a bachelor's degree in the biological sciences, and a minimum of 1 year's experience in identifying plant pests endemic to crops of commercial importance within the cooperating State, or a combination of higher education in the biological sciences and experience in identifying such plant pests, as follows: 0 years education and 5 years experience; 1 year education and 4 years experience; 2 years education and 3 years experience; 3 years education and 2 years experience; or 4 years education and 1 year experience. The years of education and experience do not have to be acquired consecutively. (iii) Successfully complete annual training provided by the State plant regulatory agency. The required training must include instruction in inspection procedures, identification of plant pests of quarantine importance to importing countries, methods of collection and submission of specimens (organisms and/or plants or plant parts) for identification, and preparation and submission of inspection report forms approved by the State plant regulatory agency. (iv) Have access to Federal or State laboratories for the positive identification of plants pests detected. (3) No agents shall inspect any plants or plant products in which they or a member of their family are directly or indirectly financially interested. (b) Inspector. (2) To be eligible for designation as an inspector, a State or county plant regulatory official must: (i) Have a bachelor's degree in the biological sciences, and a minimum of 1 year's experience in Federal, State or county plant regulatory activities, or a combination of higher education in the biological sciences and experience in State plant regulatory activities, as follows: 0 years education and 5 years experience; 1 year education and 4 years experience; 2 years education and 3 years experience; 3 years education and 2 years experience; or 4 years education and 1 year experience. The years of education and experience do not have to be acquired consecutively. (ii) Successfully complete, as indicated by receipt of a passing grade, the Animal and Plant Health Inspection Service training course on phytosanitary certification. (3) No inspectors shall inspect any plants or plant products in which they or a member of their family are directly or indirectly financially interested. (c) Applicant responsibility. (2) The applicant must furnish all labor involved in the inspection, including the moving, opening, and closing of containers. (3) Certificates may be refused for failure to comply with any of the foregoing provisions. § 353.7 Certificates. (a) Phytosanitary certificate (PPQ Form 577). (2) The original certificate shall immediately upon its issuance be delivered or mailed to the applicant or a person designated by the applicant. (3) One copy of each certificate shall be filed in the office of inspection at the port of certification, and one forwarded to the Administrator. (4) The Administrator may authorize inspectors to issue certificates on the basis of inspections made by cooperating Federal, State, and county agencies. The Administrator may also authorize inspectors to issue a certificate on the basis of a laboratory test or an inspection performed by a non-government facility accredited in accordance with § 353.8. (5) Inspectors may issue new certificates on the basis of inspections for previous certifications when the previously issued certificates can be canceled before they have been accepted by the phytopathological authorities of the country of destination involved. (b) Export certificate for processed plant products (PPQ Form 578). (2) The original certificate shall immediately upon its issuance be delivered or mailed to the applicant or a person designated by the applicant. (3) One copy of each certificate shall be filed in the office of inspection at the port of certification. (4) The Administrator may authorize inspectors to issue certificates on the basis of inspections made by cooperating Federal, State, and county agencies. The Administrator may also authorize inspectors to issue a certificate on the basis of a laboratory test or an inspection performed by a non-government facility accredited in accordance with § 353.8. (5) Inspectors may issue new certificates on the basis of inspections/processing used for previous certifications. (c) Phytosanitary certificate for reexport (PPQ Form 579). (2) The original certificate shall immediately upon its issuance be delivered or mailed to the applicant or a person designated by the applicant. (3) One copy of each certificate shall be filed in the office of inspection at the port of certification, and one forwarded to the Administrator. (4) The Administrator may authorize inspectors to issue certificates on the basis of inspections made by cooperating Federal, State, and county agencies. The Administrator may also authorize inspectors to issue a certificate on the basis of a laboratory test or an inspection performed by a non-government facility accredited in accordance with § 353.8. (5) Inspectors may issue new certificates on the basis of inspections for previous certifications when the previously issued certificates can be canceled before they have been accepted by the phytopathological authorities of the country of destination involved. (d) Industry-issued certificate. (1) Contents of written agreement. (2) Termination of agreement. (Approved by the Office of Management and Budget under control number 0579-0052 and 0579-0147) [61 FR 15368, Apr. 8, 1996, as amended at 64 FR 1105, Jan. 8, 1999; 64 FR 72265, Dec. 27, 1999; 66 FR 37116, July 17, 2001; 72 FR 35917, July 2, 2007] § 353.8 Accreditation of non-government facilities. (a) The Administrator may accredit a non-government facility to perform specific laboratory testing or phytosanitary inspection services if the Administrator determines that the non-government facility meets the criteria of paragraph (b) of this section. 1 1 (1) A non-government facility's compliance with the criteria of paragraph (b) of this section shall be determined through an assessment of the facility and its fitness to conduct the laboratory testing or phytosanitary inspection services for which it seeks to be accredited. If, after evaluating the results of the assessment, the Administrator determines that the facility meets the accreditation criteria, the facility's application for accreditation will be approved. (2) The Administrator may deny accreditation to, or withdraw the accreditation of, any non-government facility to conduct laboratory testing or phytosanitary inspection services upon a determination that the facility does not meet the criteria for accreditation or maintenance of accreditation under paragraph (b) of this section and has failed to take the remedial action recommended to correct identified deficiencies. (i) In the case of a denial, the operator of the facility will be informed of the reasons for the denial and may appeal the decision in writing to the Administrator within 10 days after receiving notification of the denial. The appeal must include all of the facts and reasons upon which the person relies to show that the facility was wrongfully denied accreditation. The Administrator will grant or deny the appeal in writing as promptly as circumstances permit, stating the reason for his or her decision. If there is a conflict as to any material fact, a hearing will be held to resolve the conflict. Rules of practice concerning the hearing will be adopted by the Administrator. (ii) In the case of withdrawal, before such action is taken, the operator of the facility will be informed of the reasons for the proposed withdrawal. The operator of the facility may appeal the proposed withdrawal in writing to the Administrator within 10 days after being informed of the reasons for the proposed withdrawal. The appeal must include all of the facts and reasons upon which the person relies to show that the reasons for the proposed withdrawal are incorrect or do not support the withdrawal of the accreditation of the facility. The Administrator will grant or deny the appeal in writing as promptly as circumstances permit, stating the reason for his or her decision. If there is a conflict as to any material fact, a hearing will be held to resolve the conflict. Rules of practice concerning the hearing will be adopted by the Administrator. However, withdrawal shall become effective pending final determination in the proceeding when the Administrator determines that such action is necessary to protect the public health, interest, or safety. Such withdrawal will be effective upon oral or written notification, whichever is earlier, to the operator of the facility. In the event of oral notification, written confirmation will be given as promptly as circumstances allow. This withdrawal will continue in effect pending the completion of the proceeding, and any judicial review thereof, unless otherwise ordered by the Administrator. (3) The Administrator will withdraw the accreditation of a non-government facility if the operator of the facility informs APHIS in writing that the facility wishes to terminate its accredited status. (4) A non-government facility whose accreditation has been denied or withdrawn may reapply for accreditation using the application procedures in paragraph (b) of this section. If the facility's accreditation was denied or withdrawn under the provisions of paragraph (a)(2) of this section, the facility operator must include with the application written documentation specifying what actions have been taken to correct the conditions that led to the denial or withdrawal of accreditation. (5) All information gathered during the course of a non-government facility's assessment and during the term of its accreditation will be treated by APHIS with the appropriate level of confidentiality, as set forth in the U.S. Department of Agriculture's administrative regulations in § 1.11 of this title. (b) Criteria for accreditation of non-government facilities. Federal Register (2) The operator of a non-government facility seeking accreditation to conduct laboratory testing or phytosanitary inspection shall submit an application to the Administrator. The application must be completed and signed by the operator of the facility or his or her authorized representative and must contain the following: (i) Legal name and full address of the facility; (ii) Name, address, and telephone and fax number of the operator of the facility or his or her authorized representative; (iii) A description of the facility, including its physical plant, primary function, scope of operation, and, if applicable, its relationship to a larger corporate entity; and (iv) A description of the specific laboratory testing or phytosanitary inspection services for which the facility is seeking accreditation. (3) Upon receipt of the application, APHIS will review the application to identify the scope of the assessment that will be required to adequately review the facility's fitness to conduct the laboratory testing or phytosanitary inspection services for which it is seeking accreditation. Before the assessment of the facility begins, the applicant's representative must agree, in writing, to fulfill the accreditation procedure, especially to receive the assessment team, to supply any information needed for the evaluation of the facility, and to enter into a trust fund agreement as provided by paragraph (c) of this section to pay the fees charged to the applicant facility regardless of the result of the assessment and to pay the charges of subsequent maintenance of the accreditation of the facility. Once the agreement has been signed, APHIS will assemble an assessment team and commence the assessment as soon as circumstances permit. The assessment team will measure the facility's fitness to conduct the laboratory testing or phytosanitary inspection services for which it is seeking accreditation against the specific standards identified by the Administrator for those services by reviewing the facility in the following areas: (i) Physical plant. (ii) Equipment. (iii) Methods of testing or inspection. (iv) Personnel. (4) To retain accreditation, the facility must agree to: (i) Observe the specific standards applicable to its area of accreditation; (ii) Be assessed and evaluated on a periodic basis by means of proficiency testing or check samples; (iii) Demonstrate on request that it is able to perform the tests or inspection services representative of those for which it is accredited; (iv) Resolve all identified deficiencies; (v) Notify APHIS as soon as possible, but no more than 10 days following its occurrence, of any change in key management personnel or facility staff accountable for the laboratory testing or phytosanitary inspection services for which the facility is accredited; and (vi) Report to APHIS as soon as possible, but no more than 10 days following its occurrence, any change involving the location, ownership, physical plant, equipment, or other conditions that existed at the facility at the time accreditation was granted. (c) Fees and trust fund agreement. (Approved by the Office of Management and Budget under control number 0579-0130) [64 FR 1105, Jan. 8, 1999, as amended at 66 FR 37400, July 18, 2001] § 353.9 Standards for accreditation of non-government facilities to perform laboratory seed health testing and seed crop phytosanitary inspection. (a) Application for accreditation, certification of accreditation, and monitoring of accredited facilities. (1) Upon determining that a facility is eligible for accreditation, the Administrator will issue the facility a certificate of accreditation. Accreditation will be for a period of 3 years from the date of issuance of the certificate of accreditation and may be renewed by submitting a new application and application fee in accordance with this paragraph. (2) The Administrator may deny or withdraw accreditation in accordance with § 353.8(a)(2) of this part. A facility may appeal denial of accreditation in accordance with § 353.8(a)(2)(i) of this part, and may appeal withdrawal of accreditation in accordance with § 353.8(a)(2)(ii) of this part. (3) A facility that has been denied accreditation or had its accreditation withdrawn may not reapply within 60 days of the date the facility was notified in writing that accreditation was denied or withdrawn. (4) After a facility is accredited, the facility must allow APHIS access to the facility and all of its equipment and records for the purpose of conducting unannounced audits to determine the facility's continuing eligibility for accreditation. Such audits will occur at least once a year and may be performed more frequently at the discretion of the Administrator. (b) Standards for accreditation. (1) Physical plant. (i) Have laboratory and office spaces enclosed by walls and locking doors to prevent unauthorized access; (ii) Conform to all State and local zoning and other ordinances; and (iii) Provide a work area that is dedicated to laboratory functions and has sufficient space to conduct the required tests and store the materials and samples required for the tests in a manner that prevents contamination by other samples in the laboratory and from other sources. (2) The facility must have access to all equipment required to conduct the laboratory testing or seed crop phytosanitary inspections for which it is accredited. Specific test methodologies, materials, and the calibration and monitoring of the equipment must conform to Reference Manual B, which is incorporated by reference at § 300.4 of this chapter. The general requirements for each test category are as follows: (i) Seed crop phytosanitary inspections. (ii) Direct visual examination. (iii) Incubation. (iv) Grow-out tests. (v) Serological tests. (vi) DNA probes. (3) Methods of testing and inspection. American National Standard: Quality Systems-Model for Quality Assurance in Design, Development, Production, Installation and Servicing. (4) Personnel. (i) Evaluation of plant or tissue samples must be undertaken by a plant pathologist or by laboratory technicians under the supervision of a plant pathologist, who may provide such supervision either on-site, or from a remote location. Where personnel are required to be trained at a facility to evaluate the particular types of plants or tissue samples handled by the facility, the training program must be evaluated by APHIS and determined to be effective. (ii) All staff must have access to and be familiar with the reference materials, guides, and manuals required for the routine performance of the tests and inspections they conduct. (Approved by the Office of Management and Budget under control number 0579-0130) [66 FR 37400, July 18, 2001, as amended at 67 FR 8466, Feb. 25, 2002]