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164 rows where part_number = 1230 sorted by section_id
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| section_id ▼ | title_number | title_name | chapter | subchapter | part_number | part_name | subpart | subpart_name | section_number | section_heading | agency | authority | source_citation | amendment_citations | full_text |
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| 14:14:5.0.1.1.20.0.1.1 | 14 | Aeronautics and Space | V | 1230 | PART 1230—PROTECTION OF HUMAN SUBJECTS | § 1230.101 To what does this policy apply? | NASA | [82 FR 7270, Jan. 19, 2017, as amended at 83 FR 2891, Jan. 22, 2018; 83 FR 28511, June 19, 2018] | (a) Except as detailed in § 1230.104, this policy applies to all research involving human subjects conducted, supported, or otherwise subject to regulation by any Federal department or agency that takes appropriate administrative action to make the policy applicable to such research. This includes research conducted by Federal civilian employees or military personnel, except that each department or agency head may adopt such procedural modifications as may be appropriate from an administrative standpoint. It also includes research conducted, supported, or otherwise subject to regulation by the Federal Government outside the United States. Institutions that are engaged in research described in this paragraph and institutional review boards (IRBs) reviewing research that is subject to this policy must comply with this policy. (b) [Reserved] (c) Department or agency heads retain final judgment as to whether a particular activity is covered by this policy and this judgment shall be exercised consistent with the ethical principles of the Belmont Report. 62 62 The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.- Belmont Report. Washington, DC: U.S. Department of Health and Human Services. 1979. (d) Department or agency heads may require that specific research activities or classes of research activities conducted, supported, or otherwise subject to regulation by the Federal department or agency but not otherwise covered by this policy comply with some or all of the requirements of this policy. (e) Compliance with this policy requires compliance with pertinent federal laws or regulations that provide additional protections for human subjects. (f) This policy does not affect any state or local laws or regulations (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe) that may otherwise be applicable and that provide additional protections for human subjects. (g) This policy does not affect any foreign laws or regul… | ||||||
| 14:14:5.0.1.1.20.0.1.10 | 14 | Aeronautics and Space | V | 1230 | PART 1230—PROTECTION OF HUMAN SUBJECTS | § 1230.111 Criteria for IRB approval of research. | NASA | (a) In order to approve research covered by this policy the IRB shall determine that all of the following requirements are satisfied: (1) Risks to subjects are minimized: (i) By using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk, and (ii) Whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes. (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research ( e.g., the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility. (3) Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted. The IRB should be particularly cognizant of the special problems of research that involves a category of subjects who are vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons. (4) Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by, § 1230.116. (5) Informed consent will be appropriately documented or appropriately waived in accordance with § 1230.117. (6) When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects. (7) When appropriate, there are adequa… | |||||||
| 14:14:5.0.1.1.20.0.1.11 | 14 | Aeronautics and Space | V | 1230 | PART 1230—PROTECTION OF HUMAN SUBJECTS | § 1230.112 Review by Institution | NASA | Research covered by this policy that has been approved by an IRB may be subject to further appropriate review and approval or disapproval by officials of the institution. However, those officials may not approve the research if it has not been approved by an IRB. | |||||||
| 14:14:5.0.1.1.20.0.1.12 | 14 | Aeronautics and Space | V | 1230 | PART 1230—PROTECTION OF HUMAN SUBJECTS | § 1230.113 Suspension or Termination of IRB Approval of Research. | NASA | An IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination of approval shall include a statement of the reasons for the IRB's action and shall be reported promptly to the investigator, appropriate institutional officials, and the department or agency head. | |||||||
| 14:14:5.0.1.1.20.0.1.13 | 14 | Aeronautics and Space | V | 1230 | PART 1230—PROTECTION OF HUMAN SUBJECTS | § 1230.114 Cooperative Research. | NASA | (a) Cooperative research projects are those projects covered by this policy that involve more than one institution. In the conduct of cooperative research projects, each institution is responsible for safeguarding the rights and welfare of human subjects and for complying with this policy. (b)(1) Any institution located in the United States that is engaged in cooperative research must rely upon approval by a single IRB for that portion of the research that is conducted in the United States. The reviewing IRB will be identified by the Federal department or agency supporting or conducting the research or proposed by the lead institution subject to the acceptance of the Federal department or agency supporting the research. (2) The following research is not subject to this provision: (i) Cooperative research for which more than single IRB review is required by law (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe); or (ii) Research for which any Federal department or agency supporting or conducting the research determines and documents that the use of a single IRB is not appropriate for the particular context. (c) For research not subject to paragraph (b) of this section, an institution participating in a cooperative project may enter into a joint review arrangement, rely on the review of another IRB, or make similar arrangements for avoiding duplication of effort. | |||||||
| 14:14:5.0.1.1.20.0.1.14 | 14 | Aeronautics and Space | V | 1230 | PART 1230—PROTECTION OF HUMAN SUBJECTS | § 1230.115 IRB Records. | NASA | (a) An institution, or when appropriate an IRB, shall prepare and maintain adequate documentation of IRB activities, including the following: (1) Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent forms, progress reports submitted by investigators, and reports of injuries to subjects. (2) Minutes of IRB meetings, which shall be in sufficient detail to show attendance at the meetings; actions taken by the IRB; the vote on these actions including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution. (3) Records of continuing review activities, including the rationale for conducting continuing review of research that otherwise would not require continuing review as described in § 1230.109(f)(1). (4) Copies of all correspondence between the IRB and the investigators. (5) A list of IRB members in the same detail as described in § 1230.108(a)(2). (6) Written procedures for the IRB in the same detail as described in § 1230.108(a)(3) and (4). (7) Statements of significant new findings provided to subjects, as required by § 1230.116(c)(5). (8) The rationale for an expedited reviewer's determination under § 1230.110(b)(1)(i) that research appearing on the expedited review list described in § 1230.110(a) is more than minimal risk. (9) Documentation specifying the responsibilities that an institution and an organization operating an IRB each will undertake to ensure compliance with the requirements of this policy, as described in § 1230.103(e). (b) The records required by this policy shall be retained for at least 3 years, and records relating to research that is conducted shall be retained for at least 3 years after completion of the research. The institution or IRB may maintain the records in printed form, or electronically. All records shall be accessible for inspection and copying by au… | |||||||
| 14:14:5.0.1.1.20.0.1.15 | 14 | Aeronautics and Space | V | 1230 | PART 1230—PROTECTION OF HUMAN SUBJECTS | § 1230.116 General Requirements for Informed Consent. | NASA | (a) General. General requirements for informed consent, whether written or oral, are set forth in this paragraph and apply to consent obtained in accordance with the requirements set forth in paragraphs (b) through (d) of this section. Broad consent may be obtained in lieu of informed consent obtained in accordance with paragraphs (b) and (c) of this section only with respect to the storage, maintenance, and secondary research uses of identifiable private information and identifiable biospecimens. Waiver or alteration of consent in research involving public benefit and service programs conducted by or subject to the approval of state or local officials is described in paragraph (e) of this section. General waiver or alteration of informed consent is described in paragraph (f) of this section. Except as provided elsewhere in this policy: (1) Before involving a human subject in research covered by this policy, an investigator shall obtain the legally effective informed consent of the subject or the subject's legally authorized representative. (2) An investigator shall seek informed consent only under circumstances that provide the prospective subject or the legally authorized representative sufficient opportunity to discuss and consider whether or not to participate and that minimize the possibility of coercion or undue influence. (3) The information that is given to the subject or the legally authorized representative shall be in language understandable to the subject or the legally authorized representative. (4) The prospective subject or the legally authorized representative must be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information. (5) Except for broad consent obtained in accordance with paragraph (d) of this section: (i) Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or l… | |||||||
| 14:14:5.0.1.1.20.0.1.16 | 14 | Aeronautics and Space | V | 1230 | PART 1230—PROTECTION OF HUMAN SUBJECTS | § 1230.117 Documentation of informed consent. | NASA | (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written informed consent form approved by the IRB and signed (including in an electronic format) by the subject or the subject's legally authorized representative. A written copy shall be given to the person signing the informed consent form. (b) Except as provided in paragraph (c) of this section, the informed consent form may be either of the following: (1) A written informed consent form that meets the requirements of § 1230.116. The investigator shall give either the subject or the subject's legally authorized representative adequate opportunity to read the informed consent form before it is signed; alternatively, this form may be read to the subject or the subject's legally authorized representative. (2) A short form written informed consent form stating that the elements of informed consent required by § 1230.116 have been presented orally to the subject or the subject's legally authorized representative, and that the key information required by § 1230.116(a)(5)(i) was presented first to the subject, before other information, if any, was provided. The IRB shall approve a written summary of what is to be said to the subject or the legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Only the short form itself is to be signed by the subject or the subject's legally authorized representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the subject's legally authorized representative, in addition to a copy of the short form. (c)(1) An IRB may waive the requirement for the investigator to obtain a signed informed consent form for some or all subjects if it finds any of the following: (i) That the only record linking the subject and the research would be the informed consent form… | |||||||
| 14:14:5.0.1.1.20.0.1.17 | 14 | Aeronautics and Space | V | 1230 | PART 1230—PROTECTION OF HUMAN SUBJECTS | § 1230.118 Applications and proposals lacking definite plans for involvement of human subjects. | NASA | Certain types of applications for grants, cooperative agreements, or contracts are submitted to Federal departments or agencies with the knowledge that subjects may be involved within the period of support, but definite plans would not normally be set forth in the application or proposal. These include activities such as institutional type grants when selection of specific projects is the institution's responsibility; research training grants in which the activities involving subjects remain to be selected; and projects in which human subjects' involvement will depend upon completion of instruments, prior animal studies, or purification of compounds. Except for research waived under § 1230.101(i) or exempted under § 1230.104, no human subjects may be involved in any project supported by these awards until the project has been reviewed and approved by the IRB, as provided in this policy, and certification submitted, by the institution, to the Federal department or agency component supporting the research. | |||||||
| 14:14:5.0.1.1.20.0.1.18 | 14 | Aeronautics and Space | V | 1230 | PART 1230—PROTECTION OF HUMAN SUBJECTS | § 1230.119 Research undertaken without the intention of involving human subjects. | NASA | Except for research waived under § 1230.101(i) or exempted under § 1230.104, in the event research is undertaken without the intention of involving human subjects, but it is later proposed to involve human subjects in the research, the research shall first be reviewed and approved by an IRB, as provided in this policy, a certification submitted by the institution to the Federal department or agency component supporting the research, and final approval given to the proposed change by the Federal department or agency component. | |||||||
| 14:14:5.0.1.1.20.0.1.19 | 14 | Aeronautics and Space | V | 1230 | PART 1230—PROTECTION OF HUMAN SUBJECTS | § 1230.120 Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal department or agency. | NASA | (a) The department or agency head will evaluate all applications and proposals involving human subjects submitted to the Federal department or agency through such officers and employees of the Federal department or agency and such experts and consultants as the department or agency head determines to be appropriate. This evaluation will take into consideration the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. (b) On the basis of this evaluation, the department or agency head may approve or disapprove the application or proposal, or enter into negotiations to develop an approvable one. | |||||||
| 14:14:5.0.1.1.20.0.1.2 | 14 | Aeronautics and Space | V | 1230 | PART 1230—PROTECTION OF HUMAN SUBJECTS | § 1230.102 Definitions for purposes of this policy. | NASA | (a) Certification means the official notification by the institution to the supporting Federal department or agency component, in accordance with the requirements of this policy, that a research project or activity involving human subjects has been reviewed and approved by an IRB in accordance with an approved assurance. (b) Clinical trial means a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. (c) Department or agency head means the head of any Federal department or agency, for example, the Secretary of HHS, and any other officer or employee of any Federal department or agency to whom the authority provided by these regulations to the department or agency head has been delegated. (d) Federal department or agency refers to a federal department or agency (the department or agency itself rather than its bureaus, offices or divisions) that takes appropriate administrative action to make this policy applicable to the research involving human subjects it conducts, supports, or otherwise regulates ( e.g., the U.S. Department of Health and Human Services, the U.S. Department of Defense, or the Central Intelligence Agency). (e)(1) Human subject means a living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. (2) Intervention includes both physical procedures by which information or biospecimens are gathered ( e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. (3) Interaction includes communication or interpersona… | |||||||
| 14:14:5.0.1.1.20.0.1.20 | 14 | Aeronautics and Space | V | 1230 | PART 1230—PROTECTION OF HUMAN SUBJECTS | § 1230.121 [Reserved] | NASA | ||||||||
| 14:14:5.0.1.1.20.0.1.21 | 14 | Aeronautics and Space | V | 1230 | PART 1230—PROTECTION OF HUMAN SUBJECTS | § 1230.122 Use of Federal funds. | NASA | Federal funds administered by a Federal department or agency may not be expended for research involving human subjects unless the requirements of this policy have been satisfied. | |||||||
| 14:14:5.0.1.1.20.0.1.22 | 14 | Aeronautics and Space | V | 1230 | PART 1230—PROTECTION OF HUMAN SUBJECTS | § 1230.123 Early termination of research support: Evaluation of applications and proposals. | NASA | (a) The department or agency head may require that Federal department or agency support for any project be terminated or suspended in the manner prescribed in applicable program requirements, when the department or agency head finds an institution has materially failed to comply with the terms of this policy. (b) In making decisions about supporting or approving applications or proposals covered by this policy the department or agency head may take into account, in addition to all other eligibility requirements and program criteria, factors such as whether the applicant has been subject to a termination or suspension under paragraph (a) of this section and whether the applicant or the person or persons who would direct or has/have directed the scientific and technical aspects of an activity has/have, in the judgment of the department or agency head, materially failed to discharge responsibility for the protection of the rights and welfare of human subjects (whether or not the research was subject to federal regulation). | |||||||
| 14:14:5.0.1.1.20.0.1.23 | 14 | Aeronautics and Space | V | 1230 | PART 1230—PROTECTION OF HUMAN SUBJECTS | § 1230.124 Conditions. | NASA | With respect to any research project or any class of research projects the department or agency head of either the conducting or the supporting Federal department or agency may impose additional conditions prior to or at the time of approval when in the judgment of the department or agency head additional conditions are necessary for the protection of human subjects. | |||||||
| 14:14:5.0.1.1.20.0.1.3 | 14 | Aeronautics and Space | V | 1230 | PART 1230—PROTECTION OF HUMAN SUBJECTS | § 1230.103 Assuring compliance with this policy—research conducted or supported by any Federal department or agency. | NASA | (a) Each institution engaged in research that is covered by this policy, with the exception of research eligible for exemption under § 1230.104, and that is conducted or supported by a Federal department or agency, shall provide written assurance satisfactory to the department or agency head that it will comply with the requirements of this policy. In lieu of requiring submission of an assurance, individual department or agency heads shall accept the existence of a current assurance, appropriate for the research in question, on file with the Office for Human Research Protections, HHS, or any successor office, and approved for Federal-wide use by that office. When the existence of an HHS-approved assurance is accepted in lieu of requiring submission of an assurance, reports (except certification) required by this policy to be made to department and agency heads shall also be made to the Office for Human Research Protections, HHS, or any successor office. Federal departments and agencies will conduct or support research covered by this policy only if the institution has provided an assurance that it will comply with the requirements of this policy, as provided in this section, and only if the institution has certified to the department or agency head that the research has been reviewed and approved by an IRB (if such certification is required by § 1230.103(d)). (b) The assurance shall be executed by an individual authorized to act for the institution and to assume on behalf of the institution the obligations imposed by this policy and shall be filed in such form and manner as the department or agency head prescribes. (c) The department or agency head may limit the period during which any assurance shall remain effective or otherwise condition or restrict the assurance. (d) Certification is required when the research is supported by a Federal department or agency and not otherwise waived under § 1230.101(i) or exempted under § 1230.104. For such research, institutions shall certify that each proposed research stu… | |||||||
| 14:14:5.0.1.1.20.0.1.4 | 14 | Aeronautics and Space | V | 1230 | PART 1230—PROTECTION OF HUMAN SUBJECTS | § 1230.104 Exempt research. | NASA | (a) Unless otherwise required by law or by department or agency heads, research activities in which the only involvement of human subjects will be in one or more of the categories in paragraph (d) of this section are exempt from the requirements of this policy, except that such activities must comply with the requirements of this section and as specified in each category. (b) Use of the exemption categories for research subject to the requirements of subparts B, C, and D: Application of the exemption categories to research subject to the requirements of 45 CFR part 46, subparts B, C, and D, is as follows: (1) Subpart B. Each of the exemptions at this section may be applied to research subject to subpart B if the conditions of the exemption are met. (2) Subpart C. The exemptions at this section do not apply to research subject to subpart C, except for research aimed at involving a broader subject population that only incidentally includes prisoners. (3) Subpart D. The exemptions at paragraphs (d)(1), (4), (5), (6), (7), and (8) of this section may be applied to research subject to subpart D if the conditions of the exemption are met. Paragraphs (d)(2)(i) and (ii) of this section only may apply to research subject to subpart D involving educational tests or the observation of public behavior when the investigator(s) do not participate in the activities being observed. Paragraph (d)(2)(iii) of this section may not be applied to research subject to subpart D. (c) [Reserved] (d) Except as described in paragraph (a) of this section, the following categories of human subjects research are exempt from this policy: (1) Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students' opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the … | |||||||
| 14:14:5.0.1.1.20.0.1.5 | 14 | Aeronautics and Space | V | 1230 | PART 1230—PROTECTION OF HUMAN SUBJECTS | §§ 1230.105-1230.106 [Reserved] | NASA | ||||||||
| 14:14:5.0.1.1.20.0.1.6 | 14 | Aeronautics and Space | V | 1230 | PART 1230—PROTECTION OF HUMAN SUBJECTS | § 1230.107 IRB membership. | NASA | (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of its members (professional competence), and the diversity of its members, including race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. The IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments (including policies and resources) and regulations, applicable law, and standards of professional conduct and practice. The IRB shall therefore include persons knowledgeable in these areas. If an IRB regularly reviews research that involves a category of subjects that is vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these categories of subjects. (b) Each IRB shall include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas. (c) Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution. (d) No IRB may have a member participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB. (e) An IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of issues that require expertise beyond or in addition to that available on the IRB. These individuals may n… | |||||||
| 14:14:5.0.1.1.20.0.1.7 | 14 | Aeronautics and Space | V | 1230 | PART 1230—PROTECTION OF HUMAN SUBJECTS | § 1230.108 IRB functions and operations. | NASA | (a) In order to fulfill the requirements of this policy each IRB shall: (1) Have access to meeting space and sufficient staff to support the IRB's review and recordkeeping duties; (2) Prepare and maintain a current list of the IRB members identified by name; earned degrees; representative capacity; indications of experience such as board certifications or licenses sufficient to describe each member's chief anticipated contributions to IRB deliberations; and any employment or other relationship between each member and the institution, for example, full-time employee, part-time employee, member of governing panel or board, stockholder, paid or unpaid consultant; (3) Establish and follow written procedures for: (i) Conducting its initial and continuing review of research and for reporting its findings and actions to the investigator and the institution; (ii) Determining which projects require review more often than annually and which projects need verification from sources other than the investigators that no material changes have occurred since previous IRB review; and (iii) Ensuring prompt reporting to the IRB of proposed changes in a research activity, and for ensuring that investigators will conduct the research activity in accordance with the terms of the IRB approval until any proposed changes have been reviewed and approved by the IRB, except when necessary to eliminate apparent immediate hazards to the subject. (4) Establish and follow written procedures for ensuring prompt reporting to the IRB; appropriate institutional officials; the department or agency head; and the Office for Human Research Protections, HHS, or any successor office, or the equivalent office within the appropriate Federal department or agency of (i) Any unanticipated problems involving risks to subjects or others or any serious or continuing noncompliance with this policy or the requirements or determinations of the IRB; and (ii) Any suspension or termination of IRB approval. (b) Except when an expedited review procedure is use… | |||||||
| 14:14:5.0.1.1.20.0.1.8 | 14 | Aeronautics and Space | V | 1230 | PART 1230—PROTECTION OF HUMAN SUBJECTS | § 1230.109 IRB review of research. | NASA | (a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy, including exempt research activities under § 1230.104 for which limited IRB review is a condition of exemption (under § 1230.104(d)(2)(iii), (d)(3)(i)(C), and (d)(7), and (8)). (b) An IRB shall require that information given to subjects (or legally authorized representatives, when appropriate) as part of informed consent is in accordance with § 1230.116. The IRB may require that information, in addition to that specifically mentioned in § 1230.116, be given to the subjects when in the IRB's judgment the information would meaningfully add to the protection of the rights and welfare of subjects. (c) An IRB shall require documentation of informed consent or may waive documentation in accordance with § 1230.117. (d) An IRB shall notify investigators and the institution in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing. (e) An IRB shall conduct continuing review of research requiring review by the convened IRB at intervals appropriate to the degree of risk, not less than once per year, except as described in § 1230.109(f). (f)(1) Unless an IRB determines otherwise, continuing review of research is not required in the following circumstances: (i) Research eligible for expedited review in accordance with § 1230.110; (ii) Research reviewed by the IRB in accordance with the limited IRB review described in § 1230.104(d)(2)(iii), (d)(3)(i)(C), or (d)(7) or (8); (iii) Research that has progressed to the point that it involves only one or both of the following, which are part of the IRB-approved study: (A) Data analysis, including … | |||||||
| 14:14:5.0.1.1.20.0.1.9 | 14 | Aeronautics and Space | V | 1230 | PART 1230—PROTECTION OF HUMAN SUBJECTS | § 1230.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research. | NASA | (a) The Secretary of HHS has established, and published as a Notice in the Federal Register, a list of categories of research that may be reviewed by the IRB through an expedited review procedure. The Secretary will evaluate the list at least every 8 years and amend it, as appropriate, after consultation with other federal departments and agencies and after publication in the Federal Register for public comment. A copy of the list is available from the Office for Human Research Protections, HHS, or any successor office. (b)(1) An IRB may use the expedited review procedure to review the following: (i) Some or all of the research appearing on the list described in paragraph (a) of this section, unless the reviewer determines that the study involves more than minimal risk; (ii) Minor changes in previously approved research during the period for which approval is authorized; or (iii) Research for which limited IRB review is a condition of exemption under § 1230.104(d)(2)(iii), (d)(3)(i)(C), and (d)(7) and (8). (2) Under an expedited review procedure, the review may be carried out by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB. In reviewing the research, the reviewers may exercise all of the authorities of the IRB except that the reviewers may not disapprove the research. A research activity may be disapproved only after review in accordance with the nonexpedited procedure set forth in § 1230.108(b). (c) Each IRB that uses an expedited review procedure shall adopt a method for keeping all members advised of research proposals that have been approved under the procedure. (d) The department or agency head may restrict, suspend, terminate, or choose not to authorize an institution's or IRB's use of the expedited review procedure. | |||||||
| 21:21:8.0.1.5.55.1.1.1 | 21 | Food and Drugs | I | L | 1230 | PART 1230—REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACT | A | Subpart A—General Provisions | § 1230.2 Scope of the act. | FDA | The provisions of the act apply to any container which has been shipped or delivered for shipment in interstate or foreign commerce, as defined in section 2(c) of the act (44 Stat. 1407; 15 U.S.C. 402) or which has been received from shipment in such commerce for sale or exchange, or which is sold or offered for sale or held for sale or exchange in any Territory or possession or in the District of Columbia. | ||||
| 21:21:8.0.1.5.55.1.1.2 | 21 | Food and Drugs | I | L | 1230 | PART 1230—REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACT | A | Subpart A—General Provisions | § 1230.3 Definitions. | FDA | (a) The word container as used in the regulations in this part means a retail parcel, package, or container suitable for household use and employed exclusively to hold any dangerous caustic or corrosive substance defined in the act. (b) The words suitable for household use mean and imply adaptability for ready or convenient handling in places where people dwell. | ||||
| 21:21:8.0.1.5.55.2.1.1 | 21 | Food and Drugs | I | L | 1230 | PART 1230—REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACT | B | Subpart B—Labeling | § 1230.10 Placement. | FDA | The label or sticker shall be so firmly attached to the container that it will remain thereon while the container is being used, and be so placed as readily to attract attention. | ||||
| 21:21:8.0.1.5.55.2.1.2 | 21 | Food and Drugs | I | L | 1230 | PART 1230—REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACT | B | Subpart B—Labeling | § 1230.11 Required wording. | FDA | (a) The common name of the dangerous caustic or corrosive substance which shall appear on the label or sticker is the name given in section 2(a) of the act (44 Stat. 1406; 15 U.S.C. 402) or any other name commonly employed to designate and identify such substance. (b) Preparations within the scope of the act bearing trade or fanciful names shall, in addition, be labeled with the common name of the dangerous caustic or corrosive substance contained therein and comply with all the other requirements of the act and of the regulations in this part. | ||||
| 21:21:8.0.1.5.55.2.1.3 | 21 | Food and Drugs | I | L | 1230 | PART 1230—REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACT | B | Subpart B—Labeling | § 1230.12 Manufacturer; distributor. | FDA | If the name on the label or sticker is other than that of the manufacturer, it shall be qualified by such words as “packed for,” “packed by,” “sold by,” or “distributed by,” as the case may be, or by other appropriate expression. | ||||
| 21:21:8.0.1.5.55.2.1.4 | 21 | Food and Drugs | I | L | 1230 | PART 1230—REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACT | B | Subpart B—Labeling | § 1230.13 Labeling of “poison”. | FDA | The following are styles of uncondensed Gothic capital letters 24-point (type face) size: When letters of not less than 24-point size are required on a label in stating the word “poison” they must not be smaller than those above set forth. | ||||
| 21:21:8.0.1.5.55.2.1.5 | 21 | Food and Drugs | I | L | 1230 | PART 1230—REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACT | B | Subpart B—Labeling | § 1230.14 Directions for treatment. | FDA | Except as provided in § 1230.16, the container shall bear in all cases upon the label or sticker thereof, immediately following the word “Poison,” directions for treatment in the case of internal personal injury; in addition, if the substance may cause external injury, directions for appropriate treatment shall be given. The directions shall prescribe such treatments for personal injury as are sanctioned by competent medical authority, and the materials called for by such directions shall be, whenever practicable, such as are usually available in the household. | ||||
| 21:21:8.0.1.5.55.2.1.6 | 21 | Food and Drugs | I | L | 1230 | PART 1230—REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACT | B | Subpart B—Labeling | § 1230.15 Responsibility for labeling directions for treatment. | FDA | A person who receives from a manufacturer or wholesaler any container which under the conditions set forth in section 2(b)(4) of the act and § 1230.16 does not bear at the time of shipment directions for treatment in the case of personal injury must place such directions on the label or sticker if he offers such container for general sale or exchange. | ||||
| 21:21:8.0.1.5.55.2.1.7 | 21 | Food and Drugs | I | L | 1230 | PART 1230—REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACT | B | Subpart B—Labeling | § 1230.16 Exemption from labeling directions for treatment. | FDA | Manufacturers and wholesalers only, at the time of shipment or delivery for shipment, are exempted from placing directions for treatment on the label or sticker of any container for other than household use, but in any event the information required by section 2(b) (1), (2), and (3) of the act (44 Stat. 1407; 15 U.S.C. 402) and the regulations in this part shall be given. | ||||
| 21:21:8.0.1.5.55.3.1.1 | 21 | Food and Drugs | I | L | 1230 | PART 1230—REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACT | C | Subpart C—Guaranty | § 1230.20 General guaranty. | FDA | In lieu of a particular guaranty for each lot of dangerous caustic or corrosive substances, a general continuing guaranty may be furnished by the guarantor to actual or prospective purchasers. The following are forms of continuing guaranties: (a) Substances for both household use and other than household use: The undersigned guarantees that the retail parcels, packages, or containers of the dangerous caustic or corrosive substance or substances to be sold to _____ are not misbranded within the meaning of the Federal Caustic Poison Act. (Date) (Signature and address of guarantor) The undersigned guarantees that the retail parcels, packages, or containers of the dangerous caustic or corrosive substance or substances to be sold to _____ are not misbranded within the meaning of the Federal Caustic Poison Act. (Date) (b) Substances for other than household use (this form may be issued only by a manufacturer or wholesaler) (§§ 1230.15, 1230.16): The dangerous caustic or corrosive substance or substances in retail parcels, packages, or containers suitable for household use to be sold to _____ are for other than household use, and guaranteed not to be misbranded within the meaning of the Federal Caustic Poison Act. (Date) (Signature and address of manufacturer or wholesaler) The dangerous caustic or corrosive substance or substances in retail parcels, packages, or containers suitable for household use to be sold to _____ are for other than household use, and guaranteed not to be misbranded within the meaning of the Federal Caustic Poison Act. (Date) | ||||
| 21:21:8.0.1.5.55.3.1.2 | 21 | Food and Drugs | I | L | 1230 | PART 1230—REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACT | C | Subpart C—Guaranty | § 1230.21 Specific guaranty. | FDA | If a guaranty in respect to any specific lot of dangerous caustic or corrosive substances be given, it shall be incorporated in or attached to the bill of sale, invoice, or other schedule bearing the date and the name and quantity of the substance sold, and shall not appear on the label or package. The following are forms of specific guaranties: (a) Substances for both household use and other than household use: The undersigned guarantees that the retail parcels, packages, or containers of the dangerous caustic or corrosive substance or substances listed herein (or specifying the substances) are not misbranded within the meaning of the Federal Caustic Poison Act. (Signature and address of guarantor) The undersigned guarantees that the retail parcels, packages, or containers of the dangerous caustic or corrosive substance or substances listed herein (or specifying the substances) are not misbranded within the meaning of the Federal Caustic Poison Act. (b) Substances for other than household use (this form may be issued only by a manufacturer or wholesaler (§§ 1230.15, 1230.16): The dangerous caustic or corrosive substance or substances listed herein (or specifying the substances) in retail parcels, packages, or containers suitable for household use are for other than household use and are guaranteed not to be misbranded within the meaning of the Federal Caustic Poison Act. (Name and address of manufacturer or wholesaler) The dangerous caustic or corrosive substance or substances listed herein (or specifying the substances) in retail parcels, packages, or containers suitable for household use are for other than household use and are guaranteed not to be misbranded within the meaning of the Federal Caustic Poison Act. | ||||
| 21:21:8.0.1.5.55.4.1.1 | 21 | Food and Drugs | I | L | 1230 | PART 1230—REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACT | D | Subpart D—Administrative Procedures | § 1230.30 Collection of samples. | FDA | Samples for examination by or under the direction and supervision of the Food and Drug Administration shall be collected by: (a) An authorized agent in the employ of the Department of Health and Human Services; (b) Any officer of any State, Territory, or possession, or of the District of Columbia, authorized by the Secretary of Health and Human Services. | ||||
| 21:21:8.0.1.5.55.4.1.2 | 21 | Food and Drugs | I | L | 1230 | PART 1230—REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACT | D | Subpart D—Administrative Procedures | § 1230.31 Where samples may be collected. | FDA | Caustic or corrosive substances within the scope of this act (44 Stat. 1406; 15 U.S.C. 401-411) may be sampled wherever found. | ||||
| 21:21:8.0.1.5.55.4.1.3 | 21 | Food and Drugs | I | L | 1230 | PART 1230—REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACT | D | Subpart D—Administrative Procedures | § 1230.32 Analyzing of samples. | FDA | Samples collected by an authorized agent shall be analyzed at the laboratory designated by the Food and Drug Administration. Only such samples as are collected in accordance with §§ 1230.30, 1230.31 may be analyzed by or under the direction and supervision of the Food and Drug Administration. Upon request one subdivision of the sample, if available, shall be delivered to the party or parties interested. | ||||
| 21:21:8.0.1.5.55.4.1.4 | 21 | Food and Drugs | I | L | 1230 | PART 1230—REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACT | D | Subpart D—Administrative Procedures | § 1230.33 Investigations. | FDA | Authorized agents in the employ of the Department of Health and Human Services may make investigations, including the inspection of premises where dangerous caustic and corrosive substances subject to the act are manufactured, packed, stored, or held for sale or distribution, and make examinations of freight and other transportation records. | ||||
| 21:21:8.0.1.5.55.4.1.5 | 21 | Food and Drugs | I | L | 1230 | PART 1230—REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACT | D | Subpart D—Administrative Procedures | § 1230.34 Analysis. | FDA | (a) The methods of examination or analysis employed shall be those prescribed by the Association of Official Agricultural Chemists, when applicable, provided, however, that any method of analysis or examination satisfactory to the Food and Drug Administration may be employed. (b) All percentages stated in the definitions in section 2(a) of the Federal Caustic Poison Act shall be determined by weight. | ||||
| 21:21:8.0.1.5.55.4.1.6 | 21 | Food and Drugs | I | L | 1230 | PART 1230—REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACT | D | Subpart D—Administrative Procedures | § 1230.35 Hearings. | FDA | Whenever it appears from the inspection, analysis, or test of any container that the provisions of section 3 or 6 of the Federal Caustic Poison Act (44 Stat. 1407, 1409; 15 U.S.C. 403, 406) have been violated and criminal proceedings are contemplated, notice shall be given to the party or parties against whom prosecution is under consideration and to other interested parties, and a date shall be fixed at which such party or parties may be heard. The hearing shall be held at the office of the Food and Drug Administration designated in the notice and shall be private and confined to questions of fact. The parties notified may present evidence, either oral or written, in person or by attorney, to show cause why the matter should not be referred for prosecution as a violation of the Federal Caustic Poison Act. | ||||
| 21:21:8.0.1.5.55.4.1.7 | 21 | Food and Drugs | I | L | 1230 | PART 1230—REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACT | D | Subpart D—Administrative Procedures | § 1230.36 Hearings; when not provided for. | FDA | No hearing is provided for when the health, medical, or drug officer or agent of any State, Territory, or possession, or of the District of Columbia, acts under the authority contained in section 8 of the Federal Caustic Poison Act (44 Stat. 1409; 15 U.S.C. 408) in reporting a violation direct to the United States attorney. | ||||
| 21:21:8.0.1.5.55.4.1.8 | 21 | Food and Drugs | I | L | 1230 | PART 1230—REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACT | D | Subpart D—Administrative Procedures | § 1230.37 Publication. | FDA | (a) After judgment of the court in any proceeding under the Federal Caustic Poison Act, notice shall be given by publication. Such notice shall include the findings of the court and may include the findings of the analyst and such explanatory statements of fact as the Secretary of Health and Human Services may deem appropriate. (b) This publication may be made in the form of a circular, notice, or bulletin, as the Secretary of Health and Human Services may direct. (c) If an appeal be taken from the judgment of the court before such publication, that fact shall appear. | ||||
| 21:21:8.0.1.5.55.5.1.1 | 21 | Food and Drugs | I | L | 1230 | PART 1230—REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACT | E | Subpart E—Imports | § 1230.40 Required label information. | FDA | Containers which are offered for import shall in all cases bear labels or stickers having thereon the information required by section 2(b) (1), (2), and (3) of the Federal Caustic Poison Act and the directions for treatment in the case of personal injury, except such directions need not appear on the label or sticker at the time of shipment by a wholesaler or manufacturer for other than household use. | ||||
| 21:21:8.0.1.5.55.5.1.10 | 21 | Food and Drugs | I | L | 1230 | PART 1230—REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACT | E | Subpart E—Imports | § 1230.49 Penalties. | FDA | (a) In case of failure to comply with the instructions or recommendations of the chief of district as to conditions under which containers may be disposed of, the District Director of Customs shall notify the chief of district in all cases coming to his attention within 3 days after inspection or after the expiration of the 3 months allowed by law if no action is taken. (b) The chief of district, upon receipt of the above-described notice, and in all cases of failure to meet the conditions imposed in order to comply with the provisions of the Federal Caustic Poison Act coming directly under his supervision, shall transmit to the District Director of Customs such evidence as he may have at hand tending to indicate the importer's liability and make a recommendation accordingly. (c) The District Director of Customs, within 3 days of the receipt of this recommendation, whether favorable or otherwise, shall notify the importer that, the legal period of 3 months for exportation or relabeling having expired, action will be taken within 30 days to enforce the terms of the bond. | ||||
| 21:21:8.0.1.5.55.5.1.2 | 21 | Food and Drugs | I | L | 1230 | PART 1230—REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACT | E | Subpart E—Imports | § 1230.41 Delivery of containers. | FDA | Containers shall not be delivered to the consignee prior to report of examination, unless a bond has been given on the appropriate form for the amount of the full invoice value of such containers, together with the duty thereon, and the refusal of the consignee to return such containers for any cause to the custody of the District Director of Customs when demanded, for the purpose of excluding them from the country or for any other purpose, the consignee shall pay an amount equal to the sum named in the bond, and such part of the duty, if any, as may be payable, as liquidated damages for failure to return to the District Director of Customs on demand all containers covered by the bond. | ||||
| 21:21:8.0.1.5.55.5.1.3 | 21 | Food and Drugs | I | L | 1230 | PART 1230—REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACT | E | Subpart E—Imports | § 1230.42 Invoices. | FDA | As soon as the importer makes entry, the invoices covering containers and the public stores packages shall be made available, with the least possible delay, for inspection by the representative of the district. When no sample is desired the invoice shall be stamped by the district “No sample desired, Food and Drug Administration, Department of Health and Human Services, per (initials of inspecting officer).” | ||||
| 21:21:8.0.1.5.55.5.1.4 | 21 | Food and Drugs | I | L | 1230 | PART 1230—REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACT | E | Subpart E—Imports | § 1230.43 Enforcement. | FDA | (a) Enforcement agency. The Federal Caustic Poison Act shall be enforced by the Food and Drug Administration, Department of Health and Human Services. (b) Enforcement of provisions. The enforcement of the provisions of the Federal Caustic Poison Act as they relate to imported dangerous caustic or corrosive substances, will, as a general rule, be under the direction of the chief of the local inspection district of the Food and Drug Administration, Department of Health and Human Services, and District Directors of Customs acting as administrative officers in carrying out directions relative to the detention, exportation, and sale, or other disposition of such substances and action under the bond in case of noncompliance with the provisions of the Federal Caustic Poison Act. (c) Chief of district as customs officer. The chief of district shall be deemed a customs officer in enforcing import regulations. (d) Nonlaboratory ports. (1) At the ports of entry where there is no district of the Food and Drug Administration, the District Director of Customs or deputy, on the day when the first notice of expected shipment of containers is received, either by invoice or entry, shall notify the chief of district in whose territory the port is located. (2) On the day of receipt of such notice the chief of district shall mail to the District Director of Customs appropriate notice, if no sample is desired. This notice serves as an equivalent to stamping the invoices at district ports with the legend “No sample desired, Food and Drug Administration, Department of Health and Human Services, per (initials of inspecting officer).” (3) If samples are desired, the Chief of district shall immediately notify the District Director of Customs. (4) The District Director of Customs at once shall forward samples, accompanied by description of shipment. (5) When samples are desired from each shipment of containers, the chief of district shall furnish to District Director of Customs and deputies at ports within the district's terr… | ||||
| 21:21:8.0.1.5.55.5.1.5 | 21 | Food and Drugs | I | L | 1230 | PART 1230—REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACT | E | Subpart E—Imports | § 1230.44 Samples. | FDA | On the same day that samples are requested by the district, the District Director of Customs or appraiser shall notify the importer that samples will be taken, that the containers must be held intact pending a notice of the result of inspection and analysis, and that in case the containers do not comply with the requirements of the Federal Caustic Poison Act, they must be returned to the District Director of Customs for disposition. This notification may be given by the District Director of Customs or appraiser through individual notices to the importer or by suitable bulletin notices posted daily in the customhouse. | ||||
| 21:21:8.0.1.5.55.5.1.6 | 21 | Food and Drugs | I | L | 1230 | PART 1230—REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACT | E | Subpart E—Imports | § 1230.45 No violation; release. | FDA | As soon as examination of the samples is completed, if no violation of the act is detected, the chief of the district shall send a notice of release to the importer and a copy of this notice to the District Director of Customs for his information. | ||||
| 21:21:8.0.1.5.55.5.1.7 | 21 | Food and Drugs | I | L | 1230 | PART 1230—REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACT | E | Subpart E—Imports | § 1230.46 Violation. | FDA | (a) If a violation of the Federal Caustic Poison Act is disclosed, the chief of the district shall send to the importer due notice of the nature of the violation and of the time and place where evidence may be presented, showing that the containers should not be refused admission. At the same time similar notice regarding detention of the containers shall be sent to the District Director of Customs, requesting him to refuse delivery thereof or to require their return to customs custody if by any chance the containers were released without the bond referred to in § 1230.41. The time allowed the importer for representations regarding the shipment may be extended at his request for a reasonable period to permit him to secure such evidence. (b) If the importer does not reply to the notice of hearing in person or by letter within the time allowed on the notice, a second notice, marked “second and last notice,” shall be sent at once by the chief of the district, advising him that failure to reply will cause definite recommendation to the District Director of Customs that the containers be refused admission and that the containers be exported within 3 months under customs supervision. | ||||
| 21:21:8.0.1.5.55.5.1.8 | 21 | Food and Drugs | I | L | 1230 | PART 1230—REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACT | E | Subpart E—Imports | § 1230.47 Rejected containers. | FDA | (a) In all cases where the containers are to be refused admission, the chief of the district within 1 day after hearing, or, if the importer does not appear or reply within 3 days after second notice, shall notify the District Director of Customs in duplicate accordingly. (b) Not later than 1 day after receipt of this notice the District Director of Customs shall sign and transmit to the importer one of the copies, which shall serve as notification to the importer that the containers must be exported under customs supervision within 3 months from such date, as provided by law; the other notice shall be retained as office record and later returned as a report to the chief of the district. In all cases the importer shall return his notice to the District Director of Customs, properly certified as to the information required, as the form provides. | ||||
| 21:21:8.0.1.5.55.5.1.9 | 21 | Food and Drugs | I | L | 1230 | PART 1230—REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACT | E | Subpart E—Imports | § 1230.48 Relabeling of containers. | FDA | (a) If containers are to be released after relabeling, a notice shall be sent by the chief of district direct to the importer, a carbon copy being sent to the District Director of Customs. This notice must state specifically the conditions to be performed, so as to bring the performance thereof under the provisions of the customs bonds on consumption and warehouse entries, these bonds including provisions requiring compliance with all of the requirements of the Federal Caustic Poison Act and all regulations and instructions issued thereunder. The notice will also state the officer to be notified by the importer when the containers are ready for inspection. (b) The importer must return the notice to the District Director of Customs or chief of district, as designated, with the certificate thereon filled out, stating that he has complied with the prescribed conditions and that the containers are ready for inspection at the place named. (c) This notice will be delivered to the inspection officer, who, after inspection, will endorse the result thereof on the back of the notice and return the same to the District Director of Customs or to the chief of district, as the case may be. (d) When the conditions to be complied with are under the supervision of the chief of district, and these conditions have been fully met, he shall release the containers to the importer, sending a copy of the notice of release to the District Director of Customs for his information. If the containers have not been properly relabeled within the period allowed, the chief of district shall immediately give notice in duplicate to the District Director of Customs of the results of inspection. The District Director of Customs shall sign and immediately transmit one copy of the notice to the importer and proceed in the usual manner. (e) If the containers are detained subject to relabeling to be performed under the supervision of the District Director of Customs, the District Director of Customs, as soon as relabeling is accomplished, will notif… | ||||
| 7:7:10.1.1.1.18.1.274.1 | 7 | Agriculture | XI | 1230 | PART 1230—PORK PROMOTION, RESEARCH, AND CONSUMER INFORMATION | A | Subpart A—Pork Promotion, Research, and Consumer Information Order | § 1230.1 Act. | AMS | Act means the Pork Promotion, Research, and Consumer Information Act of 1985 (7 U.S.C. 4801-4819) and any amendments thereto. | |||||
| 7:7:10.1.1.1.18.1.274.10 | 7 | Agriculture | XI | 1230 | PART 1230—PORK PROMOTION, RESEARCH, AND CONSUMER INFORMATION | A | Subpart A—Pork Promotion, Research, and Consumer Information Order | § 1230.10 Imported. | AMS | Imported means entered, or withdrawn from a warehouse for consumption, in the customs territory of the United States. | |||||
| 7:7:10.1.1.1.18.1.274.11 | 7 | Agriculture | XI | 1230 | PART 1230—PORK PROMOTION, RESEARCH, AND CONSUMER INFORMATION | A | Subpart A—Pork Promotion, Research, and Consumer Information Order | § 1230.11 Imported pork and pork products. | AMS | Imported pork and pork products means products which are imported into the United States which the Secretary determines contain a substantial amount of pork, including those products which have been assigned one or more of the following numbers in Schedule 1 of the Tariff Schedules of the United States Annotated (1985): 106.4020; 106.4040; 106.8000; 106.8500; 107.1000; 107.1500; 107.3020; 107.3040; 107.3060; 107.3515; 107.3525; 107.3540; and 107.3560. | |||||
| 7:7:10.1.1.1.18.1.274.12 | 7 | Agriculture | XI | 1230 | PART 1230—PORK PROMOTION, RESEARCH, AND CONSUMER INFORMATION | A | Subpart A—Pork Promotion, Research, and Consumer Information Order | § 1230.12 Importer. | AMS | Importer means a person who imports porcine animals, pork, or pork products into the United States. | |||||
| 7:7:10.1.1.1.18.1.274.13 | 7 | Agriculture | XI | 1230 | PART 1230—PORK PROMOTION, RESEARCH, AND CONSUMER INFORMATION | A | Subpart A—Pork Promotion, Research, and Consumer Information Order | § 1230.13 Market. | AMS | Market means to sell, slaughter for sale, or otherwise dispose of a porcine animal in commerce. | |||||
| 7:7:10.1.1.1.18.1.274.14 | 7 | Agriculture | XI | 1230 | PART 1230—PORK PROMOTION, RESEARCH, AND CONSUMER INFORMATION | A | Subpart A—Pork Promotion, Research, and Consumer Information Order | § 1230.14 Market value. | AMS | Market value means, with respect to porcine animals which are sold, the price at which they are sold. With respect to porcine animals slaughtered for the sale by the producer, the term means the most recent annual seven-market average for barrows and gilts, as published by the Department. With respect to imported porcine animals, the term means the declared value. With respect to imported pork and pork products, the term means an amount which represents the value of the live porcine animals from which the pork or pork products were derived, based upon the most recent annual seven-market average for barrows and gilts, as published by the Department. | |||||
| 7:7:10.1.1.1.18.1.274.15 | 7 | Agriculture | XI | 1230 | PART 1230—PORK PROMOTION, RESEARCH, AND CONSUMER INFORMATION | A | Subpart A—Pork Promotion, Research, and Consumer Information Order | § 1230.15 Part and subpart. | AMS | Part means the Pork Promotion, Research, and Consumer Information Order and all rules, regulations, and supplemental orders issued thereunder, and the aforesaid order shall be a “subpart of such part. | |||||
| 7:7:10.1.1.1.18.1.274.16 | 7 | Agriculture | XI | 1230 | PART 1230—PORK PROMOTION, RESEARCH, AND CONSUMER INFORMATION | A | Subpart A—Pork Promotion, Research, and Consumer Information Order | § 1230.16 Person. | AMS | Person means any individual, group of individuals, partnership, corporation, association, organization, cooperative, or other entity. | |||||
| 7:7:10.1.1.1.18.1.274.17 | 7 | Agriculture | XI | 1230 | PART 1230—PORK PROMOTION, RESEARCH, AND CONSUMER INFORMATION | A | Subpart A—Pork Promotion, Research, and Consumer Information Order | § 1230.17 Plans and projects. | AMS | Plans and projects means promotion, research, and consumer information plans, studies, or projects. | |||||
| 7:7:10.1.1.1.18.1.274.18 | 7 | Agriculture | XI | 1230 | PART 1230—PORK PROMOTION, RESEARCH, AND CONSUMER INFORMATION | A | Subpart A—Pork Promotion, Research, and Consumer Information Order | § 1230.18 Porcine animal. | AMS | Porcine animal means a swine, that is raised as (a) a feeder pig, that is, a young pig sold to another person to be finished for slaughtering over a period of more than 1 month; (b) for breeding purposes as seed stock and included in the breeding herd; and (c) a market hog, slaughtered by the producer or sold to be slaughtered, usually within 1 month of such transfer. | |||||
| 7:7:10.1.1.1.18.1.274.19 | 7 | Agriculture | XI | 1230 | PART 1230—PORK PROMOTION, RESEARCH, AND CONSUMER INFORMATION | A | Subpart A—Pork Promotion, Research, and Consumer Information Order | § 1230.19 Pork. | AMS | Pork means the flesh of a porcine animal. | |||||
| 7:7:10.1.1.1.18.1.274.2 | 7 | Agriculture | XI | 1230 | PART 1230—PORK PROMOTION, RESEARCH, AND CONSUMER INFORMATION | A | Subpart A—Pork Promotion, Research, and Consumer Information Order | § 1230.2 Department. | AMS | Department means the United States Department of Agriculture. | |||||
| 7:7:10.1.1.1.18.1.274.20 | 7 | Agriculture | XI | 1230 | PART 1230—PORK PROMOTION, RESEARCH, AND CONSUMER INFORMATION | A | Subpart A—Pork Promotion, Research, and Consumer Information Order | § 1230.20 Pork product. | AMS | Pork product means an edible product produced or processed in whole or in part from pork. | |||||
| 7:7:10.1.1.1.18.1.274.21 | 7 | Agriculture | XI | 1230 | PART 1230—PORK PROMOTION, RESEARCH, AND CONSUMER INFORMATION | A | Subpart A—Pork Promotion, Research, and Consumer Information Order | § 1230.21 Producer. | AMS | Producer means a person who produces porcine animals in the United States for sale in commerce. | |||||
| 7:7:10.1.1.1.18.1.274.22 | 7 | Agriculture | XI | 1230 | PART 1230—PORK PROMOTION, RESEARCH, AND CONSUMER INFORMATION | A | Subpart A—Pork Promotion, Research, and Consumer Information Order | § 1230.22 Promotion. | AMS | Promotion means any action, including but not limited to paid advertising and retail or food service merchandising, taken to present a favorable image for porcine animals, pork, or pork products to the public, or to educate producers with the intent of improving the competitive position and stimulating sales of porcine animals, pork, or pork products. | |||||
| 7:7:10.1.1.1.18.1.274.23 | 7 | Agriculture | XI | 1230 | PART 1230—PORK PROMOTION, RESEARCH, AND CONSUMER INFORMATION | A | Subpart A—Pork Promotion, Research, and Consumer Information Order | § 1230.23 Research. | AMS | Research means any action designed to advance, expand, or improve the image, desirability, nutritional value, usage, marketability, production, or quality of porcine animals, pork, or pork products, including the dissemination of the results of such research. | |||||
| 7:7:10.1.1.1.18.1.274.24 | 7 | Agriculture | XI | 1230 | PART 1230—PORK PROMOTION, RESEARCH, AND CONSUMER INFORMATION | A | Subpart A—Pork Promotion, Research, and Consumer Information Order | § 1230.24 State. | AMS | State means each of the 50 States. | |||||
| 7:7:10.1.1.1.18.1.274.25 | 7 | Agriculture | XI | 1230 | PART 1230—PORK PROMOTION, RESEARCH, AND CONSUMER INFORMATION | A | Subpart A—Pork Promotion, Research, and Consumer Information Order | § 1230.25 State association. | AMS | State association means the single organization of producers in a State that is organized under the laws of that State and is recognized by the chief executive officer of such State as representing such State's producers. If no such organization exists in a State as of January 1, 1986, the Secretary may recognize an organization that represents not fewer than 50 producers who market annually an aggregate of not less than 10 percent of the pounds of porcine animals marketed in such State. The Secretary may cease to recognize a State association and instead recognize another organization of producers in a State as that State's association if the Secretary determines either that a majority of the members of the existing State association are not producers or that a majority of the members of the other organization seeking recognition are producers and that such organization better represents the economic interests of producers. | |||||
| 7:7:10.1.1.1.18.1.274.26 | 7 | Agriculture | XI | 1230 | PART 1230—PORK PROMOTION, RESEARCH, AND CONSUMER INFORMATION | A | Subpart A—Pork Promotion, Research, and Consumer Information Order | § 1230.26 State where produced. | AMS | State where produced means with respect to a porcine animal marketed as a feeder pig or as breeding stock, the State in which that porcine animal was born, and with respect to a porcine animal that is marketed as a market hog, the State in which that porcine animal was fed for market. | |||||
| 7:7:10.1.1.1.18.1.274.3 | 7 | Agriculture | XI | 1230 | PART 1230—PORK PROMOTION, RESEARCH, AND CONSUMER INFORMATION | A | Subpart A—Pork Promotion, Research, and Consumer Information Order | § 1230.3 Secretary. | AMS | Secretary means the Secretary of Agriculture of the United States or any other officer or employee of the Department of Agriculture to whom authority has been delegated or may hereafter be delegated to act in the Secretary's stead. | |||||
| 7:7:10.1.1.1.18.1.274.4 | 7 | Agriculture | XI | 1230 | PART 1230—PORK PROMOTION, RESEARCH, AND CONSUMER INFORMATION | A | Subpart A—Pork Promotion, Research, and Consumer Information Order | § 1230.4 Board. | AMS | Board means the National Pork Board established pursuant to § 1230.50. | |||||
| 7:7:10.1.1.1.18.1.274.5 | 7 | Agriculture | XI | 1230 | PART 1230—PORK PROMOTION, RESEARCH, AND CONSUMER INFORMATION | A | Subpart A—Pork Promotion, Research, and Consumer Information Order | § 1230.5 Consumer information. | AMS | Consumer information means an activity intended to broaden the understanding of the sound nutritional attributes of pork and pork products, including the role of pork and pork products in a balanced, healthy diet. | |||||
| 7:7:10.1.1.1.18.1.274.6 | 7 | Agriculture | XI | 1230 | PART 1230—PORK PROMOTION, RESEARCH, AND CONSUMER INFORMATION | A | Subpart A—Pork Promotion, Research, and Consumer Information Order | § 1230.6 Council. | AMS | Council means the National Pork Producers Council, a nonprofit corporation of the type described in section 501(c)(5) of the Internal Revenue Code of 1954 and incorporated in the State of Iowa. | |||||
| 7:7:10.1.1.1.18.1.274.7 | 7 | Agriculture | XI | 1230 | PART 1230—PORK PROMOTION, RESEARCH, AND CONSUMER INFORMATION | A | Subpart A—Pork Promotion, Research, and Consumer Information Order | § 1230.7 Customs Service. | AMS | Customs Service means the United States Customs Service of the United States Department of Treasury. | |||||
| 7:7:10.1.1.1.18.1.274.8 | 7 | Agriculture | XI | 1230 | PART 1230—PORK PROMOTION, RESEARCH, AND CONSUMER INFORMATION | A | Subpart A—Pork Promotion, Research, and Consumer Information Order | § 1230.8 Delegate Body. | AMS | Delegate Body means the National Pork Producers Delegate Body established pursuant to § 1230.30. | |||||
| 7:7:10.1.1.1.18.1.274.9 | 7 | Agriculture | XI | 1230 | PART 1230—PORK PROMOTION, RESEARCH, AND CONSUMER INFORMATION | A | Subpart A—Pork Promotion, Research, and Consumer Information Order | § 1230.9 Fiscal period. | AMS | Fiscal period means the 12-month period ending on December 31 or such other consecutive 12-month period as the Secretary or Board may determine. | |||||
| 7:7:10.1.1.1.18.1.275.27 | 7 | Agriculture | XI | 1230 | PART 1230—PORK PROMOTION, RESEARCH, AND CONSUMER INFORMATION | A | Subpart A—Pork Promotion, Research, and Consumer Information Order | § 1230.30 Establishment and membership. | AMS | [51 FR 31903, Sept. 5, 1986, as amended at 60 FR 58501, Nov. 28, 1995] | (a) There is hereby established a National Pork Producers Delegate Body which shall consist of producers and importers appointed by the Secretary. (b)(1) At least two producer members shall be allocated to each State, but any State that has more than 300 but less than 601 shares shall receive three producer members; each State with more than 600 but less than 1,001 shares shall receive four producer members and each State with more than 1,000 shares shall receive an additional member in excess of four for each 300 additional shares in excess of 1,000 shares, rounded to the nearest 300. (2) [Reserved] (3) In each fiscal period, shares shall be assigned to each State on the basis of one share for each $1,000 (rounded to the nearest $1,000) of the net amount of assessments attributable to such State. (c)(1) The number of importer members to be appointed shall be determined by allocating three such members for the first 1,000 shares. Importers shall receive an additional member in excess of three for each 300 shares in excess of 1,000 shares, rounded to the nearest 300. (2) [Reserved] (3) In each fiscal period, shares shall be assigned to importers on the basis of one share for each $1,000 (rounded to the nearest $1,000) of the net amount of assessments attributable to importers. | ||||
| 7:7:10.1.1.1.18.1.275.28 | 7 | Agriculture | XI | 1230 | PART 1230—PORK PROMOTION, RESEARCH, AND CONSUMER INFORMATION | A | Subpart A—Pork Promotion, Research, and Consumer Information Order | § 1230.31 Nomination and appointment of producer members. | AMS | [51 FR 31903, Sept. 5, 1986, as amended at 60 FR 58501, Nov. 28, 1995] | (a) [Reserved] (b) Delegate Body nominations for appointment as producer members shall be submitted to the Secretary in the number requested by the Secretary by each State association either after an election conducted in accordance with § 1230.32 and by nominating the producers who receive the highest number of votes in such State; or pursuant to a selection process that is approved by the Secretary, is given public-notice at least one week in advance by publication in a newspaper or newspapers of general circulation in such State and in pork production and agriculture trade publications, and provides complete and equal access to every producer who has paid all assessments due under this subpart and who has not demanded any refund of an assessment paid pursuant to this subpart in the period since the selection of the previous Delegate Body; (c) The Secretary shall appoint the producer members of each Delegate Body from the nominations submitted in accordance with this section, except that if a State association does not submit nominations in the required manner or number, or if a State has no State association, the Secretary shall select producer members from that State after consultation with representatives of the pork industry in that State. | ||||
| 7:7:10.1.1.1.18.1.275.29 | 7 | Agriculture | XI | 1230 | PART 1230—PORK PROMOTION, RESEARCH, AND CONSUMER INFORMATION | A | Subpart A—Pork Promotion, Research, and Consumer Information Order | § 1230.32 Conduct of election. | AMS | [51 FR 31903, Sept. 5, 1986, as amended at 53 FR 30245, Aug. 11, 1988] | If a State association selects nominees for appointment to the Delegate Body through an election, it shall be conducted in the following manner: (a) Elections shall be administered by the Board and the Board shall determine the timing of any elections. (b) Producers who are residents of that State may be named as candidates for election to be nominees for appointment to the Delegate Body: (1) By a nominating committee of producers in that State appointed by the Board; or (2) The number of pork producers in a State shall be determined by the Department based on the latest available Department information, which tabulates by State the number of farming operations with porcine animals. (c) To be eligible to vote in an election to nominate producer members from a State, a person must: (1) Be a producer who is a resident of that State; (2) Have paid all assessments due pursuant to this subpart; and (3) Not have demanded any refund of an assessment paid pursuant to this subpart in the period since the selection of the previous Delegate Body. (d) The Board shall cause notices of any election to be published at least one week prior to the election in a newspaper or newspapers of general circulation in that State, and in pork production and agricultural trade publications. The notices shall set forth the period of time and places for voting and such other information as the Board considers necessary. (e) The identity of any person who voted and the manner in which any person voted shall be kept confidential. | ||||
| 7:7:10.1.1.1.18.1.275.30 | 7 | Agriculture | XI | 1230 | PART 1230—PORK PROMOTION, RESEARCH, AND CONSUMER INFORMATION | A | Subpart A—Pork Promotion, Research, and Consumer Information Order | § 1230.33 Appointment of importer members. | AMS | The Secretary shall appoint the importer members of each Delegate Body after consultation with importers. | |||||
| 7:7:10.1.1.1.18.1.275.31 | 7 | Agriculture | XI | 1230 | PART 1230—PORK PROMOTION, RESEARCH, AND CONSUMER INFORMATION | A | Subpart A—Pork Promotion, Research, and Consumer Information Order | § 1230.34 Term of office. | AMS | (a) The members of the Delegate Body shall serve for terms of one year, except that the members of the initial Delegate Body shall serve only until the completion of the nomination and appointment process of the succeeding Delegate Body. (b) Each member of the Delegate Body shall serve until that member's term expires, or a successor is appointed, whichever occurs later. | |||||
| 7:7:10.1.1.1.18.1.275.32 | 7 | Agriculture | XI | 1230 | PART 1230—PORK PROMOTION, RESEARCH, AND CONSUMER INFORMATION | A | Subpart A—Pork Promotion, Research, and Consumer Information Order | § 1230.35 Vacancies. | AMS | To fill any vacancy occasioned by the death, removal, resignation, or disqualification of any member of the Delegate Body, the Secretary shall appoint a successor for the unexpired term of such member from nominations made either by the appropriate State association or by importers, depending upon whether the vacancy is a producer or importer vacancy. | |||||
| 7:7:10.1.1.1.18.1.275.33 | 7 | Agriculture | XI | 1230 | PART 1230—PORK PROMOTION, RESEARCH, AND CONSUMER INFORMATION | A | Subpart A—Pork Promotion, Research, and Consumer Information Order | § 1230.36 Procedure. | AMS | (a) A majority of the members shall constitute a quorum at a properly convened meeting of the Delegate Body, but only if that majority is also entitled to cast a majority of the shares (including fractions thereof). Any action of the Delegate Body, including any motion or nomination presented to it for a vote, shall require a majority vote, that is, the concurring votes of a majority of the shares cast on that action. The Delegate Body shall give timely notice of its meetings. The Delegate Body shall give the Secretary the same notice of its meetings as it gives to its members in order that the Secretary or a representative of the Secretary may attend meetings. (b) The number of votes that may be cast by a producer member if present at a meeting shall be equal to the number of shares attributable to the State of such member divided by the number of producer members from such State. The number of votes that may be cast by an importer member if present at a meeting shall be equal to the number of shares allocated to importers divided by the number of importer members. | |||||
| 7:7:10.1.1.1.18.1.275.34 | 7 | Agriculture | XI | 1230 | PART 1230—PORK PROMOTION, RESEARCH, AND CONSUMER INFORMATION | A | Subpart A—Pork Promotion, Research, and Consumer Information Order | § 1230.37 Officers. | AMS | The Delegate Body shall elect its Chairperson by a majority vote at the first annual meeting, but at each annual meeting after the first, the President of the Board shall serve as the Delegate Body's Chairperson. | |||||
| 7:7:10.1.1.1.18.1.275.35 | 7 | Agriculture | XI | 1230 | PART 1230—PORK PROMOTION, RESEARCH, AND CONSUMER INFORMATION | A | Subpart A—Pork Promotion, Research, and Consumer Information Order | § 1230.38 Compensation and reimbursement. | AMS | The members of the Delegate Body shall serve without compensation but may be reimbursed by the Board for actual transportation expenses incurred by them in exercising their powers and duties under this subpart. Such expenses shall be paid from funds received by the Board pursuant to § 1230.72. | |||||
| 7:7:10.1.1.1.18.1.275.36 | 7 | Agriculture | XI | 1230 | PART 1230—PORK PROMOTION, RESEARCH, AND CONSUMER INFORMATION | A | Subpart A—Pork Promotion, Research, and Consumer Information Order | § 1230.39 Powers and duties of the Delegate Body. | AMS | The Delegate Body shall have the following powers and duties: (a) To meet annually; (b) To recommend the rate of assessment prescribed by the initial order and any increase in such rate; (c) To determine the percentage of the net assessments attributable to porcine animals produced in a State that each State association shall receive; and (d) To nominate not less than 23 persons, including producers from a minimum of 12 States or importers, for appointment to the initial Board and not less than one and one-half persons (rounded up to the nearest person) for each vacancy on the Board that requires nominations thereafter. Each nomination shall be by a majority vote of the Delegate Body voting in person in accordance with § 1230.36. | |||||
| 7:7:10.1.1.1.18.1.276.37 | 7 | Agriculture | XI | 1230 | PART 1230—PORK PROMOTION, RESEARCH, AND CONSUMER INFORMATION | A | Subpart A—Pork Promotion, Research, and Consumer Information Order | § 1230.50 Establishment and membership. | AMS | There is hereby established a National Pork Board of 15 members consisting of producers representing at least 12 States or importers appointed by the Secretary from nominations submitted pursuant to § 1230.39(d). The Board shall be deemed to be constituted once the Secretary makes the appointments to the Board. | |||||
| 7:7:10.1.1.1.18.1.276.38 | 7 | Agriculture | XI | 1230 | PART 1230—PORK PROMOTION, RESEARCH, AND CONSUMER INFORMATION | A | Subpart A—Pork Promotion, Research, and Consumer Information Order | § 1230.51 Term of office. | AMS | (a) The members of the Board shall serve for terms of three years, except that the members appointed to the initial Board shall be designated for, and shall serve terms as follows: One-third of such members shall serve for one year terms; One-third shall serve for two year terms; and the remaining One-third shall serve for three year terms. (b) Each member of the Board shall serve until the member's term expires, or until a successor is appointed, unless the member is removed pursuant to § 1230.55(b). (c) No member shall serve more than two consecutive terms provided that those members serving an initial term of one year are eligible to serve two additional consecutive terms, but in no event, more than seven years in total. (d) The first year of the terms of the initial Board shall begin immediately on appointment by the Secretary and continue until July 1, 1988. In subsequent years, the term of office shall begin on July 1. | |||||
| 7:7:10.1.1.1.18.1.276.39 | 7 | Agriculture | XI | 1230 | PART 1230—PORK PROMOTION, RESEARCH, AND CONSUMER INFORMATION | A | Subpart A—Pork Promotion, Research, and Consumer Information Order | § 1230.52 Nominations. | AMS | Nominations for members of the Board shall be made by the Delegate Body in accordance with § 1230.39(d). | |||||
| 7:7:10.1.1.1.18.1.276.40 | 7 | Agriculture | XI | 1230 | PART 1230—PORK PROMOTION, RESEARCH, AND CONSUMER INFORMATION | A | Subpart A—Pork Promotion, Research, and Consumer Information Order | § 1230.53 Nominee's agreement to serve. | AMS | Any person nominated to serve on the Board shall file with the Secretary at the time of the nomination a written agreement to: (a) Serve on the Board if appointed; (b) Disclose any relationship with the Council or a State association or any organization that has a contract with the Board and thereafter disclose, at any time while serving on the Board, any relationship with any organization that applies to the Board for a contract; and (c) Withdraw from participation in deliberations, decisionmaking, or voting on matters concerning any entity referred to in paragraph (b) of this section, if an officer or member of the executive committee of such entity. | |||||
| 7:7:10.1.1.1.18.1.276.41 | 7 | Agriculture | XI | 1230 | PART 1230—PORK PROMOTION, RESEARCH, AND CONSUMER INFORMATION | A | Subpart A—Pork Promotion, Research, and Consumer Information Order | § 1230.54 Appointment. | AMS | From the nominations submitted pursuant to § 1230.39(d), the Secretary shall appoint 15 producers or importers as members of the Board, but in no event shall the Secretary appoint producer members representing fewer than 12 States. | |||||
| 7:7:10.1.1.1.18.1.276.42 | 7 | Agriculture | XI | 1230 | PART 1230—PORK PROMOTION, RESEARCH, AND CONSUMER INFORMATION | A | Subpart A—Pork Promotion, Research, and Consumer Information Order | § 1230.55 Vacancies. | AMS | (a) To fill any vacancy occasioned by the death, removal, resignation, or disqualification of any member of the Board, the Secretary shall appoint a successor for the unexpired term of such member from the most recent list of nominations made by the Delegate Body. (b) If a member of the Board fails or refuses to perform the duties of a member of the Board, or if a member of the Board engages in acts of dishonesty or willful misconduct, the Board may recommend to the Secretary that that member be removed from office. If the Secretary finds that the recommendation of the Board demonstrates adequate cause, the Secretary shall remove such member from office. A person appointed under this part or any employee of the Board may be removed by the Secretary if the Secretary determines that the person's continued service would be detrimental to the purposes of the Act. | |||||
| 7:7:10.1.1.1.18.1.276.43 | 7 | Agriculture | XI | 1230 | PART 1230—PORK PROMOTION, RESEARCH, AND CONSUMER INFORMATION | A | Subpart A—Pork Promotion, Research, and Consumer Information Order | § 1230.56 Procedure. | AMS | (a) A majority of the members shall constitute a quorum at a properly convened meeting of the Board. Any action of the Board shall require the concurring votes of at least a majority of those present and voting. The Board shall give timely notice of its meetings. The Board shall give the Secretary the same notice of its meetings, including the meetings of its committees, as it gives to its members in order that the Secretary, or a representative of the Secretary, may attend the meetings. (b) The Board may take action upon the concurring votes of a majority of its members by mail, telephone, telegraph or by other means of communication when, in the opinion of the President of the Board, such action must be taken before a meeting can be called. Action taken by this emergency procedure is valid only if all members are notified and provided the opportunity to vote and any telephone vote is confirmed promptly in writing and recorded in the Board minutes. Any action so taken shall have the same force and effect as though such action had been taken at a properly convened meeting of the Board. | |||||
| 7:7:10.1.1.1.18.1.276.44 | 7 | Agriculture | XI | 1230 | PART 1230—PORK PROMOTION, RESEARCH, AND CONSUMER INFORMATION | A | Subpart A—Pork Promotion, Research, and Consumer Information Order | § 1230.57 Compensation and reimbursement. | AMS | The members of the Board shall serve without compensation but shall be reimbursed for reasonable expenses incurred by them in the exercise of their powers and the performance of their duties under this subpart. Such expenses shall be paid from funds received by the Board pursuant to § 1230.72. | |||||
| 7:7:10.1.1.1.18.1.276.45 | 7 | Agriculture | XI | 1230 | PART 1230—PORK PROMOTION, RESEARCH, AND CONSUMER INFORMATION | A | Subpart A—Pork Promotion, Research, and Consumer Information Order | § 1230.58 Powers and duties of the Board. | AMS | [51 FR 31903, Sept. 5, 1986, as amended at 53 FR 30245, Aug. 11, 1988] | The Board shall have the following powers and duties: (a) To meet not less than annually, and to organize and elect from among its members, by majority vote, a President and such other officers as may be necessary; (b) To receive and evaluate, or, on its own initiative, develop, and budget for proposals for plans and projects and to submit such plans and projects to the Secretary for approval; (c) To administer directly or through contract the provisions of this subpart in accordance with its terms and provisions; (d) To develop and submit to the Secretary for the Secretary's approval, plans and projects conducted either by the Board or others; (e) To prepare and submit to the Secretary for the Secretary's approval, which is required for the following to be implemented: (1) Budgets on a fiscal period basis of its anticipated expenses and disbursements in the administration of this subpart, including the projected cost of plans and projects to be conducted by the Board directly or by way of contract or agreement; and (2) The budget, plans, or projects for which State associations are to receive funds under § 1230.72, including a general description of the proposed plan and project contemplated therein; (f) With the approval of the Secretary, to enter into contracts or agreements with any person for the development and conduct of activities authorized under this subpart and for the payment of the cost thereof with funds collected through assessments pursuant to § 1230.71. Any such contract or agreement shall provide that: (1) The contracting party shall develop and submit to the Board a plan or project together with a budget or budgets which shall show the estimated cost to be incurred for such plan or project; (2) Any such plan or project shall become effective upon approval of the Secretary; and (3) The contracting party shall keep accurate records of all of its relevant transactions and make periodic reports to the Board of relevant activities conducted and an accounting for funds received and expende… | ||||
| 7:7:10.1.1.1.18.1.277.46 | 7 | Agriculture | XI | 1230 | PART 1230—PORK PROMOTION, RESEARCH, AND CONSUMER INFORMATION | A | Subpart A—Pork Promotion, Research, and Consumer Information Order | § 1230.60 Promotion, research, and consumer information. | AMS | (a) The Board shall receive and evaluate, or, on its own initiative, develop, and submit to the Secretary for approval, any plans and projects. Such plans and projects shall provide for: (1) The establishment, issuance, effectuation, and administration of appropriate plans and projects for promotion, research, and consumer information with respect to pork and pork products designed to strengthen the position of the pork industry in the marketplace and to maintain, develop, and expand domestic and foreign markets for pork and pork products; (2) The establishment and conduct of research and studies with respect to the sale, distribution, marketing, and utilization of pork and pork products and the creation of new products thereof, to the end that marketing and utilization of pork and pork products may be encouraged, expanded, improved, or made more acceptable. (b) Each plan and project shall be periodically reviewed or evaluated by the Board to ensure that the plan and project contributes to an effective and coordinated program of promotion, research, and consumer information. If it is found by the Board that any such plan and project does not further the purposes of the Act, the Board shall terminate such plan and project. (c) No plan or project shall make a false or misleading claim on behalf of pork or a pork product or a false or misleading statement with respect to an attribute or use of a competing product. (d) No plan or project shall undertake to advertise or promote pork or pork products by private brand or trade name unless such advertisement or promotion is specifically approved by the Board, with the concurrence of the Secretary. | |||||
| 7:7:10.1.1.1.18.1.278.47 | 7 | Agriculture | XI | 1230 | PART 1230—PORK PROMOTION, RESEARCH, AND CONSUMER INFORMATION | A | Subpart A—Pork Promotion, Research, and Consumer Information Order | § 1230.70 Expenses. | AMS | (a) The Board is authorized to incur such expenses (including provision for a reasonable reserve that would permit an effective promotion, research, and consumer information program to continue in years when the amount of assessments may be reduced) as the Secretary finds are reasonable and likely to be incurred by the Board for its administration, maintenance, and functioning and to enable it to exercise its powers and perform its duties in accordance with the provisions of this subpart, including financing plans and projects. Such expenses shall be paid from assessments collected pursuant to § 1230.71 and other funds available to the Board, including donations. (b) The Board shall reimburse the Secretary, from assessments collected pursuant to § 1230.71, for reasonable administrative expenses incurred by the Department with respect to this subpart after January 1, 1986, including any expenses reasonably incurred for the conduct of elections of nominees for appointment to the initial Delegate Body and for the conduct of referenda. | |||||
| 7:7:10.1.1.1.18.1.278.48 | 7 | Agriculture | XI | 1230 | PART 1230—PORK PROMOTION, RESEARCH, AND CONSUMER INFORMATION | A | Subpart A—Pork Promotion, Research, and Consumer Information Order | § 1230.71 Assessments. | AMS | [51 FR 31903, Sept. 5, 1986; 51 FR 36383, Oct. 10, 1986; 53 FR 1910, Jan. 25, 1988; 53 FR 30245, Aug. 11, 1988; 56 FR 6, Jan. 2, 1991] | (a)(1) Each producer producing in the United States a porcine animal raised as a feeder pig that is sold shall pay an assessment on that animal, unless such producer demonstrates to the Board by appropriate documentation that an assessment was previously paid on that animal as a feeder pig. (2) Each producer producing in the United States a porcine animal raised for slaughter that is sold shall pay an assessment on that animal, unless such producer demonstrates to the Board by appropriate documentation that an assessment was previously paid on that animal as a market hog. (3) Each producer producing in the United States a porcine animal raised for slaughter that such producer slaughters for sale shall pay an assessment on that animal unless such producer demonstrates to the Board by appropriate documentation that an assessment was previously paid on that animal as a market hog. (4) Each producer producing in the United States a porcine animal raised for breeding stock that is sold shall pay an assessment on that animal, unless such producer demonstrates to the Board by appropriate documentation that an assessment was previously paid by a person on that animal as breeding stock. (5) Each importer importing a porcine animal, pork, or pork product into the United States shall pay an assessment on that porcine animal, pork, or pork product, unless such importer demonstrates to the Board by appropriate documentation that an assessment was previously paid for that porcine animal, pork, or pork product. (b)(1) Each purchaser of a porcine animal raised by a producer as a feeder pig or market hog shall collect an assessment on such porcine animal if an assessment is due pursuant to paragraph (a) of this section, and shall remit that assessment to the Board. For the purposes of collection and remittance of assessments, any person engaged as a commission merchant, auction market, or livestock market in the business of receiving such porcine animals for sale on commission for or on behalf of a producer shall be deemed t… |
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