disposed of according to the procedures for disposing of regulated garbage, as specified in paragraph (g)(1) of this section.

(ii) After the garbage and stores referred to in paragraph (c)(2)(i) of this section were removed, the aircraft has not been in a non-Canadian foreign port.

(d) Garbage regulated because of certain movements to or from Hawaii, territories, or possessions. For purposes of this part, garbage on or removed from a means of conveyance is regulated garbage, if at the time the garbage is on or removed from the means of conveyance, the means of conveyance has moved during the previous one-year period, either directly or indirectly, to the continental United States from any territory or possession or from Hawaii; to any territory or possession from any other territory or possession or from Hawaii, or to Hawaii from any territory or possession. There are, however, two exceptions to this provision. These exceptions are as follows:

(1) Exception 1. Garbage on or removed from a means of conveyance other than an aircraft is exempt from requirements under paragraph (d) of this section if the following two conditions are met when the garbage is on or removed from the means of convey

ance:

(i) The means of conveyance is accompanied by certificate from an inspector, saying that the means of conveyance had been cleared of all garbage and all fresh fruits and vegetables; and the items cleared from the means of conveyance as prescribed by this paragraph have been disposed of according to the procedures for disposing of regulated garbage, as specified in paragraph (g)(1) of this section.

(ii) After being cleared of the garbage and stores referred to in paragraph (d)(1)(i) of this section, the means of conveyance has not moved to the continental United States from any territory or possession or from Hawaii; to any territory or possession from any other territory or possession or from Hawaii; or to Hawaii from any territory or possession.

(2) Exception 2. Garbage on or removed from an aircraft is exempt from requirements under paragraph (d) of

this section if the following two conditions are met when the garbage is on or removed from the aircraft:

(i) The aircraft had been previously cleared of all garbage and all fresh fruits and vegetables; and the items cleared from the aircraft as prescribed by this paragraph have been disposed of according to the procedures for disposing of regulated garbage, as specified in paragraph (g)(1) of this section.

(ii) After the garbage and stores referred to in paragraph (d)(2)(i) of this section were removed, the aircraft has not moved to the continental United States from any territory or possession or from Hawaii; to any territory or possession from any other territory or possession or from Hawaii; or to Hawaii from any territory or possession.

(e) Garbage that is commingled with regulated garbage is also regulated garbage.

(f) Restrictions on regulated garbage.

(1) Regulated garbage may not be disposed of, placed on, or removed from a means of conveyance except in accordance with this part.

(2) Regulated garbage is subject to general surveillance for compliance with this section by Animal and Plant Health Inspection Service inspectors and to disposal measures authorized by the Plant Protection Act and the Animal Health Protection Act to prevent the introduction and dissemination of pests and diseases of plants and livestock.

(g)(1) All regulated garbage must be contained in tight, leak-proof covered receptacles during storage on board a means of conveyance while in the territorial waters, or while otherwise within the territory of the United States. All such receptacles shall be contained inside the guard rail if on a watercraft. Such regulated garbage shall not be unloaded from such means of conveyance in the United States unless such regulated garbage is removed in tight, leak-proof receptacles under the direction of an Animal and Plant Health Inspection Service inspector to an approved facility for incineration, sterilization, or grinding into an approved sewage system, under supervision by such an inspector, or such regulated garbage is removed for other handling

in such manner and under such supervision as may, upon request in specific cases, be approved by the Administrator as complying with the applicable laws for environmental protection and as adequate to prevent the dissemination into or within the United States of plant pests and livestock or poultry diseases. Provided that, a cruise ship may dispose of regulated garbage in landfills at Alaskan ports only, if and only if the cruise ship does not have prohibited or restricted meat or animal products on board at the time it enters Alaskan waters for the cruise season, and only if the cruise ship, except for incidental travel through international waters necessary to navigate safely between ports, remains in Canadian and U.S. waters off the west coast of North America, and calls only at continental U.S. and Canadian ports during the entire cruise season.

(2) Application for approval of a facility or sewage system may be made in writing by the authorized representative of any carrier or by the official having jurisdiction over the port or place of arrival of the means of conveyance, to the Administrator, Animal and Plant Health Inspection Service, U.S. Department of Agriculture, Washington, DC 20250. The application shall be endorsed by the operator of the facility or sewage system. Approval will be granted if the Administrator determines that the requirements set forth in this section are met. Approval may be denied or withdrawn at any time, if the Administrator determines that such requirements are not met, after notice of the proposed denial or withdrawal of the approval and the reasons therefor, and an opportunity to demonstrate or achieve compliance with such requirements, has been afforded to the operator of the facility or sewage system and to the applicant for approval. However, approval may also be withdrawn without such prior procedure in any case in which the public health, interest, or safety requires immediate action, and in such case, the operator of the facility or sewage system and the applicant for approval shall promptly thereafter be given notice of the withdrawal and the reasons therefor and an opportunity to show

cause why the approval should be reinstated.

(h) The Plant Protection and Quarantine Programs and Veterinary Services, Animal, and Plant Health Inspection Service, will cooperate with other Federal, State, and local agencies responsible for enforcing other statutes and regulations governing disposal of the regulated garbage to the end that such disposal shall be adequate to prevent the dissemination of plant pests and livestock or poultry diseases and comply with applicable laws for environmental protection. The inspectors, in maintaining surveillance over regulated garbage movements and disposal, shall coordinate their activities with the activities of representatives of the Environmental Protection Agency and other Federal, State, and local agencies also having jurisdiction over such regulated garbage.

(i) As used in this section:

(1) Sterilization" means cooking regulated garbage at 212 °F. for 30 minutes and disposal of the residue by burying in a landfill, except that the burial provisions do not apply to materials extracted from the residue after cooking and determined by the Administrator to be unsuitable for use as food or as soil additives.

(2) Incineration means to reduce the regulated garbage to ash by burning;

(3) Approved sewage system means a sewage system approved by the Administrator, Animal and Plant Health Inspection Service, upon his determination that the system is designed and operated in such a way as to preclude the discharge of sewage effluents onto land surfaces or into lagoons or other stationary waters, and otherwise is adequate to prevent the dissemination of plant pests and livestock or poultry diseases, and that is certified by an appropriate Government official as currently complying with the applicable laws for environmental protection.

(4) Approved facility means a facility approved by the Administrator, Animal and Plant Health Inspection Service, upon his determination that it has equipment and uses procedures that are adequate to prevent the dissemination of plant pests and livestock or poultry diseases, and that it is certified by an appropriate Government official

as currently complying with the applicable laws for environmental protection.

(5) Carrier means the principal operator of a means of conveyance.

(j) Compliance agreement and cancellation. (1) Any person engaged in the business of handling or disposing of regulated garbage must first enter into a compliance agreement with the Animal and Plant Health Inspection Service (APHIS). Compliance agreement forms (PPQ Form 519) are available without charge from local USDA/ APHIS/Plant Protection and Quarantine offices, which are listed in telephone directories.

(2) A person who enters into a compliance agreement, and employees or agents of that person, shall comply with the following conditions and any supplemental conditions which shall be listed in the compliance agreement, as deemed by the Administrator to be necessary to prevent the dissemination into or within the United States of plant pests and livestock or poultry diseases:

(i) Comply with the provisions of 7 CFR 330.400;

(ii) Allow APHIS inspectors access to all records maintained by the person regarding handling or disposal of regulated garbage, and to all areas where handling or disposal of regulated garbage occurs;

(iii) Remove regulated garbage from a means of conveyance only in tight, leak-proof receptacles;

(iv) Move the receptacles of regulated garbage only to a facility approved in accordance with §330.400(g)(2); and

(v) At the approved facility, dispose of the regulated garbage only through incineration, sterilization, grinding into a sewage system approved in accordance with §330.400(g)(2), or in any other manner approved by the Administrator and described in the compliance agreement.

(3) Approval for a compliance agreement may be denied at any time if the Administrator determines that the requirements set forth in this subpart are not met, after notice of, and the reasons for, the proposed denial of the approval, and an opportunity to demonstrate or achieve compliance with such requirements, has been afforded

to the compliance agreement applicant.

(4) Any compliance agreement may be canceled in writing by the Administrator whenever it is found that the person who has entered into the compliance agreement has failed to comply with this subpart. Any person whose compliance agreement has been cancelled may appeal the decision, in writing, within 10 days after receiving written notification of the cancellation. The appeal must state all of the facts and reasons upon which the person relies to show that the compliance agreement was wrongfully cancelled. As promptly as circumstances allow, the Administrator will grant or deny the appeal, in writing, stating the reasons for the decision. A hearing will be held to resolve any conflict as to any material fact. Rules of practice concerning a hearing will be adopted by the Administrator. This administrative remedy must be exhausted before a person can file suit in court challenging the cancellation of a compliance agree

ment.

(5) Where a compliance agreement is denied or cancelled, regulated garbage may continue to be unloaded from a means of conveyance and disposed of at an approved facility in accordance with §330.400(g)(1).

(Approved by the Office of Management and Budget under control number 0579-0054)

[39 FR 32320, Sept. 6, 1974, as amended at 43 FR 39954, Sept. 8, 1978; 45 FR 80268, Dec. 4, 1980; 48 FR 57466, Dec. 30, 1983; 58 FR 66248, Dec. 20, 1993; 62 FR 19903, Apr. 24, 1997; 66 FR 21058, Apr. 27, 2001; 68 FR 6342, Feb. 7, 2003]

(a) The regulations in this part are effective on February 11, 2003. On and after that date, any person possessing, using, or transferring any agent or toxin listed in § 331.3 must be in compliance with the provisions of this part. However, so as not to disrupt research or educational projects involving listed agents or toxins that were underway as of the effective date of this part, any E person possessing such agents or toxins as of the effective date (current possessors) will be afforded additional time to reach full compliance with this part. Any provision not specifically cited in paragraphs (a)(1) through (a)(6) of this section will be applicable as of February 11, 2003. In addition, any individual or entity who does not possess listed agents or toxins by the effective date of this part, but who wishes to initiate a research or educational project prior to November 12, 2003, must be in compliance with the provisions of this part that are applicable for current possessors at the time of application, as provided in paragraphs through (a)(5) of this section.

(a)(1)

(1) During the period from February 11, 2003, to November 12, 2003, biological agents or toxins listed in §331.3 may only be transferred to an individual or entity that is not registered under this part if the individual or entity has been issued a permit by the Administrator under part 330 of this chapter to import or move interstate that specific agent or toxin. If an individual or entity has not been issued a permit under part 330 of this chapter, the individual or entity may apply for a permit. To

receive an agent or toxin, an individual or entity will also be required to submit APHIS Form 2041, in accordance with §331.13(c). Because USDA permits do not cover intrastate movement, an individual or entity may not receive a listed agent or toxin that is being moved intrastate until that individual or entity is registered in accordance with this part.

(2) By March 12, 2003, the responsible official must submit the registration application package as required in § 331.8. In addition, the responsible official must submit to the Attorney General the names and identifying information for the responsible official; alternate responsible official, where applicable; entity; and, where applicable, the individual who owns or controls the entity.

(3) By April 11, 2003, the responsible official must submit to the Attorney General the names and identifying information for all individuals whom the responsible official has identified as having a legitimate need to handle or use listed agents or toxins, and who have the appropriate training and skills to handle such agents or toxins, as required in § 331.10.

(4) By June 12, 2003, the responsible official must submit to APHIS the security section of the Biocontainment and Security Plan required in § 331.11.

(5) By September 12, 2003, the responsible official must implement the security section of the Biocontainment and Security Plan, as required in §331.11, and provide security training in accordance with 7 CFR 331.12.

(6) By November 12, 2003, the registration application process must be complete and the entity in full compliance with the regulations in this part, except as otherwise provided in paragraphs (b) and (c) of this section.

(b) Provisional registration. (1) Notwithstanding the provisions in paragraph (a) of this section, APHIS may issue a provisional registration certificate to current possessors if, as of November 12, 2003:

(i) The Attorney General has received all of the information, including fingerprint cards, required by the Attorney General to conduct a security risk assessment of the entity, including any

individual who owns or controls the entity; and

(ii) The entity otherwise meets all of the requirements of this part.

(2) Notwithstanding the provisions in paragraph (a) of this section, APHIS may issue a provisional registration certificate to individuals and entities that did not possess listed biological agents or toxins as of February 11, 2003, if, as of November 12, 2003:

(i) The Attorney General has received all of the information, including fingerprint cards, required by the Attorney General to conduct a security risk assessment of the entity, including any individual who owns or controls the entity;

(ii) The entity otherwise meets all of the requirements of this part; and

(iii) The Administrator finds that circumstances warrant such action in the interest of the health of plants or plant products or national security.

(3) A provisional registration certificate will be effective until APHIS either issues a certificate of registration or suspends or revokes the provisional registration.

(c) Notwithstanding the provisions in paragraph (a) of this section, APHIS may issue a provisional grant of access for individuals identified by an entity as having a legitimate need to handle or use agents or toxins listed in §331.3 if, as of November 12, 2003, the Attorney General has received all of the information, including fingerprint cards, required by the Attorney General to conduct a security risk assessment of that individual. A provisional grant of access will be effective until APHIS grants or denies access to biological agents or toxins listed in § 331.3. [68 FR 62220, Nov. 3, 2003]

§ 331.1 Definitions.

Administrator. The Administrator, Animal and Plant Health Inspection Service, or any person authorized to act for the Administrator.

Animal and Plant Health Inspection Service (APHIS). The Animal and Plant Health Inspection Service of the United States Department of Agriculture.

Attorney General. The Attorney General of the United States or any person authorized to act for the Attorney General.

pro

Biological agent. Any microorganism (including, but not limited to, bacteria, viruses, fungi, rickettsiae, or tozoa), or infectious substance, or any naturally occurring, bioengineered, or synthesized component of any such microorganism or infectious substance, capable of causing:

(1) Death, disease, or other biological malfunction in a human, an animal, a plant, or another living organism;

(2) Deterioration of food, water, equipment, supplies, or material of any kind; or

(3) Deleterious alteration of the environment.

Centers for Disease Control and Prevention (CDC). The Centers for Disease Control and Prevention of the United States Department of Health and Human Services.

Diagnostic laboratory. A laboratory facility that receives specimens for the purpose of determining the identities of pests, pathogens, contaminants, or causes of disease.

Entity. Any government agency (Federal, State, or local), academic institution, corporation, company, partnership, society, association, firm, sole proprietorship, or other legal entity.

Import. To move into, or the act of movement into, the territorial limits of the United States.

Interstate. From one State into or through any other State, or within the District of Columbia, Guam, the Virgin Islands of the United States, or any other territory or possession of the United States.

Permit. A written authorization by the Administrator to import or move interstate biological agents or toxins, under conditions prescribed by the Administrator.

PPQ. The Plant Protection and Quarantine Programs of the Animal and Plant Health Inspection Service

Responsible official. The individual designated by an entity to act on its behalf. This individual must have the authority and control to ensure compliance with the regulations in this part.

Specimen. A sample of material collected for use in testing, such as plant tissues (e.g., stems, seeds, flowers, pollen, leaves, roots, fruits, tubers, tissue