Export Certification (7 CFR 353.1-353.9)

495 Animal and Plant Health Inspection Service, USDA § 353.1 moved through the United States ports for exportation in accordance with the regulations in part 319 of this chapter. (g) Costs. Costs shall be borne by the owner of the fruit as provided in § 352.14. This includes all costs for preinspection and convoying of loaded trucks and supervision of transloading from trucks to approved carriers or storage in United States ports when augmented inspection service has to be provided for such preinspection, con voying, and supervision. (Approved by the Office of Management and Budget under control number 0579–0303) [25 FR 1929, Mar. 5, 1960, as amended at 36 FR 24917, Dec. 24, 1971; 37 FR 10554, May 25, 1972; 55 FR 23066, June 6, 1990; 56 FR 13066, Mar. 29, 1991; 67 FR 46578, July 16, 2002; 71 FR 49325, Aug. 23, 2006; 72 FR 39528, July 18, 2007; 75 FR 4253, Jan. 26, 2010] PART 353—EXPORT CERTIFICATION Sec. 353.1 Definitions. 353.2 Purpose and administration. 353.3 Where service is offered. 353.4 Products covered. 353.5 Application for certification. 353.6 Inspection. 353.7 Certificates. 353.8 Accreditation of non-government fa cilities. 353.9 Standards for accreditation of non government facilities to perform labora tory seed health testing and seed crop phytosanitary inspection. 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. The Administrator, Animal and Plant Health Inspection Service, or any person authorized to act for the Administrator. Agent. An individual who meets the eligibility requirements set forth in § 353.6, and who is designated by the Animal and Plant Health Inspection Service to conduct phytosanitary field inspections of seed crops to serve as a basis for the issuance of phytosanitary certificates. Animal and Plant Health Inspection Service (APHIS). The Animal and Plant Health Inspection Service of the U.S. Department of Agriculture. Consignment. One shipment of plants or plant products, from one exporter, to one consignee, in one country, on one means of conveyance; or any mail shipment to one consignee. Export certificate for processed plant products. A certificate (PPQ Form 578 or an approved electronic equivalent) issued by an inspector, describing the plant health condition of processed or manufactured plant products based on inspection of submitted samples and/or by virtue of the processing received. Family. An inspector or agent and his or her spouse, their parents, children, and first cousins. Industry-issued certificate. A certifi cate issued by a representative of the concerned agricultural or forestry in dustry under the terms of a written agreement with the Animal and Plant Health Inspection Service, giving as surance that a plant product has been handled, processed, or inspected in a manner required by a foreign govern ment. An industry-issued certificate includes an ISPM 15 quality/treatment mark. Inspector. An employee of the Animal and Plant Health Inspection Service, or a State or county plant regulatory offi cial designated by the Secretary of Ag riculture to inspect and certify to ship pers and other interested parties, as to the phytosanitary condition of plant products inspected under the Act. Non-government facility. A laboratory, research facility, inspection service, or other entity that is maintained, at least in part, for the purpose of pro viding laboratory testing or phytosanitary inspection services and that is not operated by the Federal Government or by the government of a State or a subdivision of a State. Office of inspection. The office of an inspector of plants and plant products covered by this part. Phytosanitary certificate. A certificate (PPQ Form 577 or an approved elec tronic equivalent) issued by an inspec tor, giving the phytosanitary condition of domestic plants or unprocessed or unmanufactured plant products based on inspection of the entire lot or rep resentative samples drawn by a Federal VerDate Sep<11>2014 09:24 Feb 15, 2018 Jkt 244016 PO 00000 Frm 00505 Fmt 8010 Sfmt 8010 Y:\SGML\244016.XXX 244016ns h a tt u ck o n D S K 9 F 9 S C 4 2 P R O D w ith C F R 496 7 CFR Ch. III (1–1–18 Edition) § 353.2 or State employee authorized to con duct such sampling. Phytosanitary certificate for reexport. A certificate (PPQ Form 579 or an ap proved electronic equivalent) issued by an inspector, giving the phytosanitary condition of foreign plants and plant products legally imported into the United States and subsequently offered for reexport. The certificate certifies that, based on the original foreign phytosanitary certificate and/or addi tional inspection or treatment in the United States, the plants and plant products are considered to conform to the current phytosanitary regulations of the receiving country and have not been subjected to the risk of infesta tion or infection during storage in the United States. Plants and plant prod ucts which transit the United States under Customs bond are not eligible to receive the phytosanitary certificate for reexport. Plant pests. Any living stage of any insects, mites, nematodes, slugs, snails, protozoa, or other invertebrate animals, bacteria, fungi, other para sitic plants or reproductive parts thereof, viruses, or any organisms similar to or allied with any of the foregoing, or any infectious substances, which can directly or indirectly injure or cause disease or damage in any plants or parts thereof, or other prod ucts of plants. Plant products. Products derived from nursery stock, other plants, plant parts, roots, bulbs, seeds, fruits, nuts, and vegetables, including manufac tured or processed products. Plants and plant products. Nursery stock, other plants, plant parts, roots, bulbs, seeds, fruits, nuts, vegetables and other plant products, including manufactured or processed products. Reference Manual A. The Reference Manual for Administration, Procedures, and Policies of the National Seed Health System, published by the National Seed Health System (NSHS). Reference Manual A describes the structure, ad ministration, procedures, policies, and working practices of the NSHS and also contains relevant documentation, forms, and references for the NSHS. Reference Manual A is incorporated by reference at § 300.3 of this chapter, and is available by writing to Phytosanitary Issues Management, Operational Support, PPQ, APHIS, 4700 River Road Unit 140, Riverdale, MD 20737–1236, and on the APHIS Web site at http://www.aphis.usda.gov/ppq/pim/ac creditation. Reference Manual B. The Reference Manual for Seed Health Testing and Phytosanitary Field Inspection Methods, published by the National Seed Health System (NSHS). Reference Manual B contains the detailed seed health test ing, seed sampling, and inspection pro cedures for the NSHS. Reference Man ual B is incorporated by reference at § 300.4 of this chapter, and is available by writing to Phytosanitary Issues Management, Operational Support, PPQ, APHIS, 4700 River Road Unit 140, Riverdale, MD 20737–1236, and on the APHIS Web site at http:// www.aphis.usda.gov/ppq/pim/accredita tion. State. Any of the States of the United States, the District of Columbia, Amer ican Samoa, Guam, the Northern Mar iana Islands, Puerto Rico, or the Virgin Islands of the United States. The Act. Title IV of Public Law 106– 224, 114 Stat. 438, 7 U.S.C. 7701–7772, which was enacted June 20, 2000. [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 serv ice to exporters. After assessing the phytosanitary condition of the plants or plant products intended for export, relative to the receiving country’s reg ulations, an inspector issues an inter nationally recognized phytosanitary certificate, a phytosanitary certificate for reexport, or an export certificate for processed plant products if war ranted. APHIS also enters into written agreements with industry to allow the issuance of industry-issued certificates giving assurance that a plant product VerDate Sep<11>2014 09:24 Feb 15, 2018 Jkt 244016 PO 00000 Frm 00506 Fmt 8010 Sfmt 8010 Y:\SGML\244016.XXX 244016ns h a tt u ck o n D S K 9 F 9 S C 4 2 P R O D w ith C F R 497 Animal and Plant Health Inspection Service, USDA § 353.5 has been handled, processed, or in spected in a manner required by a for eign 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 loca tion of inspectors who may issue cer tificates 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 Ave nue, Building 1, North, Gulfport, MS 39501. FL, AL, GA, KY, MS, TN, NC, SC, PR, US VI. Central, 3505 Boca Chica Blvd., Suite 360, Browns ville, TX 78521–4065. TX, OK, NE, AR, KS, LA, IA, MO, ND, SD. Western, 9580 Micron Ave nue, 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 terres trial plants listed in 50 CFR part 17 or 23 are available only at a port des ignated 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 Endan gered 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) listed in 50 CFR 23.23: 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 (Venus flytrap): Wilmington, NC § 353.4 Products covered. Plants and plant products when of fered for export or re-export. § 353.5 Application for certification. (a) To request the services of an in spector, a written application (PPQ Form 572) shall be made as far in ad vance 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 in formation exchange system or other authorized method. (b) Each application shall be deemed filed when delivered to the proper of fice of inspection. When an application is filed, a record showing the date and time of filing shall be made in such of fice. (c) Only one application for any con signment shall be accepted, and only VerDate Sep<11>2014 09:24 Feb 15, 2018 Jkt 244016 PO 00000 Frm 00507 Fmt 8010 Sfmt 8010 Y:\SGML\244016.XXX 244016ns h a tt u ck o n D S K 9 F 9 S C 4 2 P R O D w ith C F R 498 7 CFR Ch. III (1–1–18 Edition) § 353.6 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 per form field inspections in accordance with this part and who have success fully completed training in accordance with paragraph (a)(2)(iii) of this sec tion. Employees of a State plant pro tection agency who are not agents may perform field inspections only under the supervision of an inspector. (a) Agent. (1) Agents may conduct phytosanitary field inspections of seed crops in cooperation with and on behalf of those State plant regulatory agen cies electing to use agents and main taining a Memorandum of Under standing with the Animal and Plant Health Inspection Service in accord ance with the regulations. The Memo randum of Understanding must state that agents shall be used in accordance with the regulations in this part. Agents are not authorized to issue Fed eral phytosanitary certificates, but are only authorized to conduct the field in spections of seed crops required as a basis for determining phytosanitary condition prior to the issuance of a phytosanitary certificate for the crops. (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-caus ing 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 edu cation 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 train ing must include instruction in inspec tion procedures, identification of plant pests of quarantine importance to im porting countries, methods of collec tion and submission of specimens (or ganisms 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 identifica tion 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. (1) An employee of the Animal and Plant Health Inspection Service, or a State or county regu latory official designated by the Sec retary of Agriculture to inspect and certify to shippers and other interested parties, as to the phytosanitary condi tion of plants and plant products in spected under the Act. (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 bi ological 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 indi cated by receipt of a passing grade, the Animal and Plant Health Inspection Service training course on phytosanitary certification. VerDate Sep<11>2014 09:24 Feb 15, 2018 Jkt 244016 PO 00000 Frm 00508 Fmt 8010 Sfmt 8010 Y:\SGML\244016.XXX 244016ns h a tt u ck o n D S K 9 F 9 S C 4 2 P R O D w ith C F R 499 Animal and Plant Health Inspection Service, USDA § 353.7 (3) No inspectors shall inspect any plants or plant products in which they or a member of their family are di rectly or indirectly financially inter ested. (c) Applicant responsibility. (1) When the services of an agent or an inspector are requested, the applicant shall make the plant or plant product accessible for inspection and identification and so place the plant or plant product to per mit physical inspection of the lot for plant pests. (2) The applicant must furnish all labor involved in the inspection, in cluding the moving, opening, and clos ing of containers. (3) Certificates may be refused for failure to comply with any of the fore going provisions. § 353.7 Certificates. (a) Phytosanitary certificate (PPQ Form 577). (1) For each consignment of domestic plants or unprocessed plant products for which certification is re quested, the inspector shall sign and issue a separate certificate based on the findings of the inspection. (2) The original certificate shall im mediately upon its issuance be deliv ered 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 for warded to the Administrator. (4) The Administrator may authorize inspectors to issue certificates on the basis of inspections made by cooper ating Federal, State, and county agen cies. The Administrator may also au thorize inspectors to issue a certificate on the basis of a laboratory test or an inspection performed by a non-govern ment facility accredited in accordance with § 353.8. (5) Inspectors may issue new certifi cates on the basis of inspections for previous certifications when the pre viously issued certificates can be can celed 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). (1) For each consignment of processed plant prod ucts for which certification is re quested, the inspector shall sign and issue a certificate based on the inspec tor’s findings after inspecting sub mitted samples and/or by virtue of processing received. (2) The original certificate shall im mediately upon its issuance be deliv ered 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 cooper ating Federal, State, and county agen cies. The Administrator may also au thorize inspectors to issue a certificate on the basis of a laboratory test or an inspection performed by a non-govern ment facility accredited in accordance with § 353.8. (5) Inspectors may issue new certifi cates on the basis of inspections/proc essing used for previous certifications. (c) Phytosanitary certificate for reex port (PPQ Form 579). (1) For each con signment of foreign origin plants or un processed plant products for which cer tification is requested, the inspector shall sign and issue a certificate based on the original foreign phytosanitary certificate and/or additional inspection or treatment in the United States after determining that the consignment con forms to the current phytosanitary regulations of the receiving country and has not been subjected to the risk of infestation or infection during stor age in the United States. (2) The original certificate shall im mediately upon its issuance be deliv ered 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 for warded to the Administrator. (4) The Administrator may authorize inspectors to issue certificates on the basis of inspections made by cooper ating Federal, State, and county agen cies. The Administrator may also au thorize inspectors to issue a certificate on the basis of a laboratory test or an inspection performed by a non-govern ment facility accredited in accordance with § 353.8. (5) Inspectors may issue new certifi cates on the basis of inspections for VerDate Sep<11>2014 09:24 Feb 15, 2018 Jkt 244016 PO 00000 Frm 00509 Fmt 8010 Sfmt 8010 Y:\SGML\244016.XXX 244016ns h a tt u ck o n D S K 9 F 9 S C 4 2 P R O D w ith C F R 500 7 CFR Ch. III (1–1–18 Edition) § 353.8 1 A list of accredited non-government fa cilities may be obtained by writing to Phytosanitary Issues Management, PPQ, APHIS, 4700 River Road, Unit 140, Riverdale, MD 20737–1236. previous certifications when the pre viously issued certificates can be can celed before they have been accepted by the phytopathological authorities of the country of destination involved. (d) Industry-issued certificate. A cer tificate issued under the terms of a written agreement between the Animal and Plant Health Inspection Service and an agricultural or forestry com pany or association giving assurance that a plant product has been handled, processed, or inspected in a manner re quired by a foreign government. An in dustry-issued certificate includes an ISPM 15 quality/treatment mark. The certificate may be issued by the indi vidual who signs the agreement or his/ her delegate. (1) Contents of written agreement. In each written agreement, APHIS shall agree to cooperate and coordinate with the signatory agricultural or forestry company or association to facilitate the issuance of industry-issued certifi cates and to monitor activities under the agreement, and the concerned agri cultural or forestry company or asso ciation agrees to comply with the re quirements of the agreement. Each agreement shall specify the articles subject to the agreement and any measures necessary to prevent the in troduction and dissemination into specified foreign countries of specified injurious plant pests. These measures could include such treatments as re frigeration, heat treatment, kiln dry ing, etc., and must include all nec essary preshipment inspections and subsequent sign-offs and product label ing as identified by Plant Protection and Quarantine (PPQ), APHIS, based on the import requirements of the for eign country. (2) Termination of agreement. An agreement may be terminated by any signatory to the agreement by giving written notice of termination to the other party. The effective date of the termination will be 15 days after the date of actual receipt of the written notice. Any agreement may be imme diately withdrawn by the Adminis trator if he or she determines that arti cles covered by the agreement were moved in violation of any requirement of this chapter or any provision of the agreement. If the withdrawal is oral, the decision to withdraw the agree ment and the reasons for the with drawal of the agreement shall be con firmed in writing as promptly as cir cumstances permit. Withdrawal of an agreement may be appealed in writing to the Administrator within 10 days after receipt of the written notification of the withdrawal. The appeal shall state all of the facts and reasons upon which the appellant relies to show that the agreement was wrongfully with drawn. The Administrator shall grant or deny the appeal, in writing, stating the reasons for granting or denying the appeal as promptly as circumstances permit. If there is a conflict as to any material fact and the person from whom the agreement is withdrawn re quests a hearing, a hearing shall be held to resolve the conflict. Rules of practice concerning the hearing shall be adopted by the Administrator. No written agreement will be signed with an individual or a company representa tive of the concerned agricultural or forestry company or association who has had a written agreement with drawn during the 12 months following such withdrawal, unless the withdrawn agreement was reinstated upon appeal. (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-govern ment 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 cri teria of paragraph (b) of this section. 1 (1) A non-government facility’s com pliance with the criteria of paragraph (b) of this section shall be determined through an assessment of the facility VerDate Sep<11>2014 09:24 Feb 15, 2018 Jkt 244016 PO 00000 Frm 00510 Fmt 8010 Sfmt 8010 Y:\SGML\244016.XXX 244016ns h a tt u ck o n D S K 9 F 9 S C 4 2 P R O D w ith C F R 501 Animal and Plant Health Inspection Service, USDA § 353.8 and its fitness to conduct the labora tory testing or phytosanitary inspec tion services for which it seeks to be accredited. If, after evaluating the re sults of the assessment, the Adminis trator determines that the facility meets the accreditation criteria, the facility’s application for accreditation will be approved. (2) The Administrator may deny ac creditation to, or withdraw the accred itation 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 rec ommended to correct identified defi ciencies. (i) In the case of a denial, the oper ator of the facility will be informed of the reasons for the denial and may ap peal the decision in writing to the Ad ministrator within 10 days after receiv ing notification of the denial. The ap peal must include all of the facts and reasons upon which the person relies to show that the facility was wrongfully denied accreditation. The Adminis trator 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 rea sons 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 with drawal 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 deci sion. If there is a conflict as to any ma terial fact, a hearing will be held to re solve the conflict. Rules of practice concerning the hearing will be adopted by the Administrator. However, with drawal shall become effective pending final determination in the proceeding when the Administrator determines that such action is necessary to pro tect the public health, interest, or safe ty. Such withdrawal will be effective upon oral or written notification, whichever is earlier, to the operator of the facility. In the event of oral notifi cation, 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 fa cility wishes to terminate its accred ited status. (4) A non-government facility whose accreditation has been denied or with drawn may reapply for accreditation using the application procedures in paragraph (b) of this section. If the fa cility’s accreditation was denied or withdrawn under the provisions of paragraph (a)(2) of this section, the fa cility 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 ac creditation. (5) All information gathered during the course of a non-government facili ty’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 adminis trative regulations in § 1.11 of this title. (b) Criteria for accreditation of non government facilities. (1) Specific stand ards for accreditation in a particular area of laboratory testing or phytosanitary inspection are set forth in this part and may be obtained by writing to APHIS. If specific standards for accreditation in a particular area of laboratory testing or phytosanitary in spection have not been promulgated by APHIS, and the Administrator deter mines that accreditation in that area VerDate Sep<11>2014 09:24 Feb 15, 2018 Jkt 244016 PO 00000 Frm 00511 Fmt 8010 Sfmt 8010 Y:\SGML\244016.XXX 244016ns h a tt u ck o n D S K 9 F 9 S C 4 2 P R O D w ith C F R 502 7 CFR Ch. III (1–1–18 Edition) § 353.8 is practical, APHIS will develop appro priate standards applicable to accredi tation in the area for which the non government facility is seeking accredi tation and publish a notice of proposed rulemaking in the FEDERAL REGISTER to inform the public and other inter ested persons of the opportunity to comment on and participate in the de velopment of those standards. (2) The operator of a non-government facility seeking accreditation to con duct 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 facil ity or his or her authorized representa tive; (iii) A description of the facility, in cluding its physical plant, primary function, scope of operation, and, if ap plicable, its relationship to a larger corporate entity; and (iv) A description of the specific lab oratory testing or phytosanitary in spection 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 re view the facility’s fitness to conduct the laboratory testing or phytosanitary inspection services for which it is seeking accreditation. Be fore the assessment of the facility be gins, the applicant’s representative must agree, in writing, to fulfill the ac creditation procedure, especially to re ceive the assessment team, to supply any information needed for the evalua tion 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 assess ment and to pay the charges of subse quent maintenance of the accredita tion of the facility. Once the agree ment has been signed, APHIS will as semble an assessment team and com mence the assessment as soon as cir cumstances 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 identi fied by the Administrator for those services by reviewing the facility in the following areas: (i) Physical plant. The facility’s phys ical plant (e.g., laboratory space, office space, greenhouses, vehicles, etc.) must meet the criteria identified in the ac creditation standards as necessary to properly conduct the laboratory test ing or phytosanitary inspection serv ices for which it seeks accreditation. (ii) Equipment. The facility’s per sonnel must possess or have unre stricted access to the equipment (e.g., microscopes, computers, scales, triers, etc.) identified in the accreditation standards as necessary to properly con duct the laboratory testing or phytosanitary inspection services for which it seeks accreditation. The cali bration and monitoring of that equip ment must be documented and conform to prescribed standards. (iii) Methods of testing or inspection. The facility must have a quality man ual or equivalent documentation that describes the system in place at the fa cility for the conduct of the laboratory testing or phytosanitary inspection services for which the facility seeks ac creditation. The manual must be avail able to, and in use by, the facility per sonnel who perform the services. The methods and procedures followed by the facility to conduct the laboratory testing or phytosanitary inspection services for which it seeks accredita tion must be commensurate with those identified in the accreditation stand ards and must be consistent with or equivalent to recognized international standards for such testing or inspec tion. (iv) Personnel. The management and facility personnel accountable for the laboratory testing or phytosanitary in spection services for which the facility is seeking accreditation must be iden tified and must possess the training, education, or experience identified in the accreditation standards as nec essary to properly conduct the testing VerDate Sep<11>2014 09:24 Feb 15, 2018 Jkt 244016 PO 00000 Frm 00512 Fmt 8010 Sfmt 8010 Y:\SGML\244016.XXX 244016ns h a tt u ck o n D S K 9 F 9 S C 4 2 P R O D w ith C F R 503 Animal and Plant Health Inspection Service, USDA § 353.9 or inspection services for which the fa cility seeks accreditation, and that training, education, or experience must be documented. (4) To retain accreditation, the facil ity must agree to: (i) Observe the specific standards ap plicable 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 inspec tion services representative of those for which it is accredited; (iv) Resolve all identified defi ciencies; (v) Notify APHIS as soon as possible, but no more than 10 days following its occurrence, of any change in key man agement personnel or facility staff ac countable for the laboratory testing or phytosanitary inspection services for which the facility is accredited; and (vi) Report to APHIS as soon as pos sible, but no more than 10 days fol lowing its occurrence, any change in volving the location, ownership, phys ical plant, equipment, or other condi tions that existed at the facility at the time accreditation was granted. (c) Fees and trust fund agreement. The fees charged by APHIS in connection with the initial accreditation of a non government facility and the mainte nance of that accreditation shall be adequate to recover the costs incurred by the government in the course of APHIS’ accreditation activities. To cover those costs, the operator of the facility seeking accreditation must enter into a trust fund agreement with APHIS under which the operator of the facility will pay in advance all esti mated costs that APHIS expects to incur through its involvement in the pre-accreditation assessment process and the maintenance of the facility’s accreditation. Those costs shall include administrative expenses incurred in those activities, such as laboratory fees for evaluating check test results, and all salaries (including overtime and the Federal share of employee ben efits), travel expenses (including per diem expenses), and other incidental expenses incurred by the APHIS in per forming those activities. The operator of the facility must deposit a certified or cashier’s check with APHIS for the amount of the costs, as estimated by APHIS. If the deposit is not sufficient to meet all costs incurred by APHIS, the operator of the facility must de posit another certified or cashier’s check with APHIS for the amount of the remaining costs, as determined by APHIS, before APHIS’ services will be completed. After a final audit at the conclusion of the pre-accreditation as sessment, any overpayment of funds will be returned to the operator of the facility or held on account until needed for future activities related to the maintenance of the facility’s accredita tion. (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 per form laboratory seed health testing and seed crop phytosanitary inspec tion. (a) Application for accreditation, certifi cation of accreditation, and monitoring of accredited facilities. A facility may apply to be accredited to perform lab oratory seed health testing or seed crop phytosanitary inspection, or to renew such accreditation, by submit ting an application in accordance with § 353.8(b)(2) of this part. If there are portions of the application deemed to contain trade secret or confidential business information (CBI), each page of the application containing such in formation should be marked ‘‘CBI Copy.’’ The application must be accom panied by a copy of the facility’s qual ity manual and a nonrefundable appli cation fee of $1,000. The applicant must make additional deposits to cover the costs of gaining and maintaining ac creditation into a trust fund estab lished in accordance with § 353.8(c) of this part upon request by the Adminis trator. (1) Upon determining that a facility is eligible for accreditation, the Ad ministrator will issue the facility a certificate of accreditation. Accredita tion 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 VerDate Sep<11>2014 09:24 Feb 15, 2018 Jkt 244016 PO 00000 Frm 00513 Fmt 8010 Sfmt 8010 Y:\SGML\244016.XXX 244016ns h a tt u ck o n D S K 9 F 9 S C 4 2 P R O D w ith C F R 504 7 CFR Ch. III (1–1–18 Edition) § 353.9 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 ac creditation in accordance with § 353.8(a)(2)(ii) of this part. (3) A facility that has been denied ac creditation or had its accreditation withdrawn may not reapply within 60 days of the date the facility was noti fied 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 con ducting unannounced audits to deter mine the facility’s continuing eligi bility 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. A facil ity that, in accordance with § 353.8(b)(2) of this part, applies to be accredited to perform laboratory seed health testing or seed crop phytosanitary inspection will be evaluated for accreditation against these standards: (1) Physical plant. The facility’s phys ical plant (e.g., laboratory space, office space, greenhouses, vehicles, etc.) must: (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 dedi cated to laboratory functions and has sufficient space to conduct the required tests and store the materials and sam ples 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 methodolo gies, materials, and the calibration and monitoring of the equipment must con form 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. Seed crop phytosanitary inspection may also include related activities such as collection of seed samples for later laboratory testing, visual inspec tion of seed just prior to export, and in spection of greenhouses or growth chambers where plants are grown for seed production, as well as visual in spection of seed crops. In the field, in spectors must use accurate field maps, hand lenses, and secure containers for the collection, storage, and transpor tation of samples. Inspectors must have direct access to a laboratory that is fully equipped to carry out any nec essary diagnostic tests needed for field samples. (ii) Direct visual examination. Visual examination of seed requires a stereo microscope. Visual examination of tis sue requires a compound light micro scope. Visual examination of loosely attached or accompanying material re quires a centrifuge and shaker. (iii) Incubation. Required equipment includes incubation chambers, laminar flow hoods, media preparation equip ment, scales, pH meters, distilled and sterile water, gas burners, an auto clave, and the appropriate media for the specified tests. (iv) Grow-out tests. Grow-out tests re quire a greenhouse, growth chamber, or an outdoor quarantine location, and access to a laboratory that is fully equipped to carry out any required di agnostic tests. (v) Serological tests. These tests re quire grinding, extraction, and sample purification equipment; fluorescent mi croscopes; plate readers; spectrophotometers; and the appro priate assay materials; or the appro priate equipment to use field ready test kits. (vi) DNA probes. To conduct these tests, a laboratory must be equipped with polymerase chain reaction (PCR) equipment, including thermal cyclers, electrophoresis and gel blotting equip ment, and the reagents and DNA polymerases necessary to conduct the PCR. (3) Methods of testing and inspection. The facility must conduct its labora tory seed health testing and seed crop VerDate Sep<11>2014 09:24 Feb 15, 2018 Jkt 244016 PO 00000 Frm 00514 Fmt 8010 Sfmt 8010 Y:\SGML\244016.XXX 244016ns h a tt u ck o n D S K 9 F 9 S C 4 2 P R O D w ith C F R 505 Animal and Plant Health Inspection Service, USDA § 354.1 phytosanitary inspection procedures in accordance with Reference Manual B. The facility must have a quality man ual documenting its quality system for laboratory seed health testing and seed crop phytosanitary inspection proce dures. The quality system must follow the general guidelines described in ANSI/ASQC Q9001–1994, American Na tional Standard: Quality Systems-Model for Quality Assurance in Design, Develop ment, Production, Installation and Serv icing. Acceptable models for quality systems for accredited facilities are also described in detail in Reference Manual A, which is incorporated by reference at § 300.3 of this chapter. The personnel who perform the testing and inspection services must comply with the quality manual, and management must enforce this compliance. The fa cility must maintain documented pro cedures for identification, collection, indexing, access, filing, storage, main tenance, and disposition of quality sys tem records. The facility must main tain quality system records to dem onstrate conformance to the quality manual and the effective operation of the quality system. (4) Personnel. There must be a selec tion procedure and a training system to ensure technical competence of all staff members. The education, tech nical knowledge, and experience re quired to perform assigned test and in spection functions must be documented and clearly defined. In addition: (i) Evaluation of plant or tissue sam ples must be undertaken by a plant pa thologist or by laboratory technicians under the supervision of a plant pathol ogist, who may provide such super vision 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 mate rials, 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] PART 354—OVERTIME SERVICES RE LATING TO IMPORTS AND EX PORTS; AND USER FEES Sec. 354.1 Overtime work at border ports, sea ports, and airports. 354.2 Administrative instructions pre scribing commuted traveltime. 354.3 User fees for certain international services. 354.4 User fees for certain domestic services. 354.5 Penalties for nonpayment or late pay ment of user fees. AUTHORITY: 7 U.S.C. 7701–7772, 7781–7786, and 8301–8317; 21 U.S.C. 136 and 136a; 49 U.S.C. 80503; 7 CFR 2.22, 2.80, and 371.3. § 354.1 Overtime work at border ports, sea ports, and airports. (a)(1) Any person, firm, or corpora tion having ownership, custody, or con trol of plants, plant products, animals, animal byproducts, or other commod ities or articles subject to inspection, laboratory testing, certification, or quarantine under this chapter and sub chapter D of chapter I, title 9 CFR, who requires the services of an employee of the Animal and Plant Health Inspec tion Service or U.S. Customs and Bor der Protection on a Sunday or holiday, or at any other time outside the reg ular tour of duty of that employee, shall sufficiently in advance of the pe riod of Sunday, holiday, or overtime service request the Animal and Plant Health Inspection Service or U.S. Cus toms and Border Protection inspector in charge to furnish the service during the overtime or Sunday or holiday pe riod, and shall pay the Government at the rate listed in the following table, except as provided in paragraphs (a)(1)(i), (ii), and (iii), and (a)(3) of this section: VerDate Sep<11>2014 09:24 Feb 15, 2018 Jkt 244016 PO 00000 Frm 00515 Fmt 8010 Sfmt 8010 Y:\SGML\244016.XXX 244016ns h a tt u ck o n D S K 9 F 9 S C 4 2 P R O D w ith C F R