cfr_sections
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
65 rows where part_number = 355 sorted by section_id
This data as json, CSV (advanced)
Suggested facets: title_name, chapter, subchapter, part_name, subpart, subpart_name, amendment_citations
part_number 1
- 355 · 65 ✖
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 20:20:1.0.2.11.62.0.155.1 | 20 | Employees' Benefits | II | E | 355 | PART 355—REGULATIONS UNDER THE ADMINISTRATIVE FALSE CLAIMS ACT | § 355.1 Basis and purpose. | SSA | (a) Basis. This part implements the Administrative False Claims Act, codified at 31 U.S.C. 3801-3812. The statute at 31 U.S.C. 3809 requires each authority head to promulgate regulations necessary to implement the provisions of the statute. (b) Purpose. This part— (1) Establishes administrative procedures for imposing civil penalties and assessments against persons who make, submit, or present, or cause to be made, submitted, or presented, false, fictitious, or fraudulent claims or written statements to authorities or to their agents; and (2) Specifies the hearing and appeal rights of persons subject to allegations of liability for such claims and statements. | ||||||
| 20:20:1.0.2.11.62.0.155.10 | 20 | Employees' Benefits | II | E | 355 | PART 355—REGULATIONS UNDER THE ADMINISTRATIVE FALSE CLAIMS ACT | § 355.10 [Reserved] | SSA | |||||||
| 20:20:1.0.2.11.62.0.155.11 | 20 | Employees' Benefits | II | E | 355 | PART 355—REGULATIONS UNDER THE ADMINISTRATIVE FALSE CLAIMS ACT | § 355.11 Referral of request for hearing to the presiding officer. | SSA | (a) No earlier than 30 days after service of the complaint, the reviewing official shall file the complaint and any answer or request for a hearing filed by the respondent with the presiding officer by submitting a copy of the complaint and any answer or request for hearing filed by the respondent with the Civilian Board of Contract Appeals. (b) If the Chair of the Civilian Board of Contract Appeals declines the referral of the complaint described in paragraph (a) of this section, the reviewing official may submit the complaint and any answer or request for hearing to any other board of contract appeals. (c) Simultaneously with the submission of a referral under paragraph (a) or (b) of this section, the reviewing official shall serve the respondent with a notice in the manner prescribed by § 355.8 that the referral has been made to an agency board of contract appeals with an explanation as to where the respondent may obtain the relevant rules of procedure promulgated by the board of contract appeals. (d) Upon acceptance of the referral, the presiding officer shall conduct the hearing according to the rules and procedures promulgated by the board of contract appeals for cases under the Administrative False Claims Act. | ||||||
| 20:20:1.0.2.11.62.0.155.12 | 20 | Employees' Benefits | II | E | 355 | PART 355—REGULATIONS UNDER THE ADMINISTRATIVE FALSE CLAIMS ACT | §§ 355.12-355.19 [Reserved] | SSA | |||||||
| 20:20:1.0.2.11.62.0.155.13 | 20 | Employees' Benefits | II | E | 355 | PART 355—REGULATIONS UNDER THE ADMINISTRATIVE FALSE CLAIMS ACT | § 355.20 Disclosure of documents. | SSA | (a) Upon written request to the reviewing official, the respondent is entitled to review any relevant and material documents, transcripts, records, and other materials that relate to the allegations set out in the complaint and upon which the findings and conclusions of the investigating official under § 355.4(b) are based unless such documents are subject to a privilege under Federal law. Upon payment of reasonable fees for duplication, the respondent may obtain copies of such documents. (b) Upon written request to the reviewing official, the respondent is also entitled to a copy of all exculpatory information in the possession of the reviewing official or investigating official relating to the allegations in the complaint, even if it is contained in a document that would otherwise be privileged. If the document would otherwise be privileged, only that portion containing exculpatory information must be disclosed. (c) The notice sent to the Attorney General from the reviewing official as described in § 355.5 is not discoverable under any circumstances. | ||||||
| 20:20:1.0.2.11.62.0.155.14 | 20 | Employees' Benefits | II | E | 355 | PART 355—REGULATIONS UNDER THE ADMINISTRATIVE FALSE CLAIMS ACT | §§ 355.21-355.39 [Reserved] | SSA | |||||||
| 20:20:1.0.2.11.62.0.155.15 | 20 | Employees' Benefits | II | E | 355 | PART 355—REGULATIONS UNDER THE ADMINISTRATIVE FALSE CLAIMS ACT | § 355.40 Stays ordered by the Department of Justice. | SSA | If at any time the Attorney General or an Assistant Attorney General designated by the Attorney General transmits to the authority head a written finding that continuation of the administrative process described in this part with respect to a claim or statement may adversely affect any pending or potential criminal or civil action related to such claim or statement, the authority head shall stay the process immediately. The authority head may order the process resumed only upon receipt of the written authorization of the Attorney General. | ||||||
| 20:20:1.0.2.11.62.0.155.16 | 20 | Employees' Benefits | II | E | 355 | PART 355—REGULATIONS UNDER THE ADMINISTRATIVE FALSE CLAIMS ACT | § 355.41 [Reserved] | SSA | |||||||
| 20:20:1.0.2.11.62.0.155.17 | 20 | Employees' Benefits | II | E | 355 | PART 355—REGULATIONS UNDER THE ADMINISTRATIVE FALSE CLAIMS ACT | § 355.42 Judicial review. | SSA | The statute at 31 U.S.C. 3805 authorizes judicial review by an appropriate U.S. District Court of a final decision of the presiding officer imposing penalties or assessments under this part and specifies the procedures for such review. | ||||||
| 20:20:1.0.2.11.62.0.155.18 | 20 | Employees' Benefits | II | E | 355 | PART 355—REGULATIONS UNDER THE ADMINISTRATIVE FALSE CLAIMS ACT | § 355.43 Collection of civil penalties and assessments. | SSA | The statutes at 31 U.S.C. 3806 and 3808(b) authorize actions for collection of civil penalties and assessments imposed under this part and specify the procedures for such actions. | ||||||
| 20:20:1.0.2.11.62.0.155.19 | 20 | Employees' Benefits | II | E | 355 | PART 355—REGULATIONS UNDER THE ADMINISTRATIVE FALSE CLAIMS ACT | § 355.44 Right to administrative offset. | SSA | The amount of any penalty or assessment which has become final, or for which a judgment has been entered under § 355.42 or § 355.43, or any amount agreed upon in a compromise or settlement under § 355.46, may be collected by administrative offset under 31 U.S.C. 3716, except that an administrative offset may not be made under this section against a refund of an overpayment of Federal taxes, then or later owing by the United States to the respondent. | ||||||
| 20:20:1.0.2.11.62.0.155.2 | 20 | Employees' Benefits | II | E | 355 | PART 355—REGULATIONS UNDER THE ADMINISTRATIVE FALSE CLAIMS ACT | § 355.2 Definitions. | SSA | Authority means Railroad Retirement Board. Authority head means the three-member Railroad Retirement Board. Claim means any request, demand, or submission— (1) Made to the authority for property, services, or money (including money representing grants, loans, insurance, or benefits); (2) Made to a recipient of property, services, or money from the authority or to a party to a contract with the authority— (i) For property or services if the United States— (A) Provided such property or services; (B) Provided any portion of the funds for the purchase of such property or services; or (C) Will reimburse such recipient or party for the purchase of such property or services; or (ii) For the payment of money (including money representing grants, loans, insurance, or benefits) if the United States— (A) Provided any portion of the money requested or demanded; or (B) Will reimburse such recipient or party for any portion of the money paid on such request or demand; or (3) Made to the authority which has the effect of concealing or improperly avoiding or decreasing an obligation to pay or transmit property, services, or money to the authority. Complaint means the written notice of allegations of liability referred to a presiding officer and served by the reviewing official on the respondent under § 355.7. Government means the U.S. Government. Investigating official means the Inspector General of the authority or an officer or employee of the Office of the Inspector General designated by the Inspector General and serving in a position for which the rate of basic pay is not less than 120 percent of the minimum rate of basic pay for grade GS-15 under the General Schedule. Knows or has reason to know means that a person, with respect to a claim or statement— (1) Has actual knowledge that the claim or statement is false, fictitious, or fraudulent; (2) Acts in deliberate ignorance of the truth or falsity of the claim or statement; or (3) Acts in reckless disregard of the truth or falsity of the claim or s… | ||||||
| 20:20:1.0.2.11.62.0.155.20 | 20 | Employees' Benefits | II | E | 355 | PART 355—REGULATIONS UNDER THE ADMINISTRATIVE FALSE CLAIMS ACT | § 355.45 Deposit in Treasury of United States. | SSA | All amounts collected pursuant to this part shall be credited first to reimburse the authority or other Federal entity that expended costs in support of the investigation or prosecution of the action, including any court or hearing costs. Such reimbursements shall be deposited in the appropriations account of the authority or other Federal entity from which the costs were obligated, a similar appropriations account of the authority or other Federal entity, or another appropriate account if the authority or other Federal entity expended nonappropriated funds, and shall remain available until expended. Any amount remaining after such reimbursements are credited shall be deposited as miscellaneous receipts in the Treasury of the United States. | ||||||
| 20:20:1.0.2.11.62.0.155.21 | 20 | Employees' Benefits | II | E | 355 | PART 355—REGULATIONS UNDER THE ADMINISTRATIVE FALSE CLAIMS ACT | § 355.46 Compromise or settlement. | SSA | (a) Parties may make offers of compromise or settlement at any time. (b) The reviewing official shall notify the Attorney General in writing no later than 30 days before entering into any agreement to compromise or settle allegations of liability under this part and before the date on which the reviewing official is permitted to issue a complaint. (c) The reviewing official has the exclusive authority to compromise or settle a case under this part at any time after the date on which the reviewing official is permitted to issue a complaint and before the date on which the presiding officer issues a decision. (d) The Attorney General has exclusive authority to compromise or settle any penalty or assessment under this part during the pendency of any review under § 355.42 or of any action to recover penalties and assessments under 31 U.S.C. 3806. (e) Any compromise or settlement must be in writing. | ||||||
| 20:20:1.0.2.11.62.0.155.22 | 20 | Employees' Benefits | II | E | 355 | PART 355—REGULATIONS UNDER THE ADMINISTRATIVE FALSE CLAIMS ACT | § 355.47 Limitations. | SSA | The complaint with respect to a claim or statement must be served in the manner specified in § 355.8 not later than the later of— (a) 6 years after the date on which such claim or statement is made; or (b) 3 years after the date on which facts material to the action are known or reasonably should have been known by the authority head, but in no event more than 10 years after the date on which the claim or statement was made. | ||||||
| 20:20:1.0.2.11.62.0.155.3 | 20 | Employees' Benefits | II | E | 355 | PART 355—REGULATIONS UNDER THE ADMINISTRATIVE FALSE CLAIMS ACT | § 355.3 Basis for civil penalties and assessments. | SSA | (a) Claims. (1) Except as provided in paragraph (c) of this section, any person who makes, presents, or submits or causes to be made, presented, or submitted, a claim that the person knows or has reason to know— (i) Is false, fictitious, or fraudulent; (ii) Includes or is supported by any written statement which asserts a material fact which is false, fictitious, or fraudulent; (iii) Includes or is supported by any written statement that— (A) Omits a material fact; (B) Is false, fictitious, or fraudulent as a result of such omission; and (C) Is a statement in which the person making such statement has a duty to include such material fact; or (iv) Is for payment for the provision of property or services which the person has not provided as claimed, shall be subject, in addition to any other remedy that may be prescribed by law, to a civil penalty of not more than $5,000 for each such claim. This penalty is subject to adjustment in accord with part 356 of this chapter. (2) Each voucher, invoice, claim form, or other individual request or demand for property, services, or money constitutes a separate claim. (3) A claim shall be considered made to an authority, recipient, or party when such claim is actually made to an agent, fiscal intermediary, or other entity, including any state or political subdivision thereof, acting for or on behalf of such authority, recipient, or party. (4) Each claim for property, services, or money is subject to a civil penalty regardless of whether such property, services, or money is actually delivered or paid. (5) If the Government has made any payment (including transferred property or provided services) on a claim, a person subject to a civil penalty under paragraph (a)(1) of this section shall also be subject to an assessment of not more than twice the amount of such claim or that portion thereof that is determined to be in violation of paragraph (a)(1). Such assessment shall be in lieu of damages sustained by the Government because of such claim. However, such assessmen… | ||||||
| 20:20:1.0.2.11.62.0.155.4 | 20 | Employees' Benefits | II | E | 355 | PART 355—REGULATIONS UNDER THE ADMINISTRATIVE FALSE CLAIMS ACT | § 355.4 Investigation. | SSA | (a) If an investigating official concludes that a subpoena pursuant to the authority conferred by 31 U.S.C. 3804(a) is warranted— (1) The subpoena so issued shall notify the person to whom it is addressed of the authority under which the subpoena is issued and shall identify the records or documents sought; (2) He or she may designate a person to act on his behalf to receive the documents sought; and (3) The person receiving such subpoena shall be required to tender to the investigating official or the person designated to receive the documents a certification that the documents sought have been produced, or that such documents are not available and the reasons therefor, or that such documents, suitably identified, have been withheld based upon the assertion of an identified privilege. (b) If the investigating official concludes that an action under this part may be warranted, the investigating official shall submit a report containing the findings and conclusions of such investigation to the reviewing official. (c) Nothing in this section shall preclude or limit an investigating official's discretion to refer allegations directly to the Department of Justice for suit under the False Claims Act or other civil relief, or to preclude or limit such official's discretion to defer or postpone a report or referral to avoid interference with a criminal investigation or prosecution. (d) Nothing in this section modifies any responsibility of an investigating official to report violations of criminal law to the Attorney General. | ||||||
| 20:20:1.0.2.11.62.0.155.5 | 20 | Employees' Benefits | II | E | 355 | PART 355—REGULATIONS UNDER THE ADMINISTRATIVE FALSE CLAIMS ACT | § 355.5 Review by the reviewing official. | SSA | (a) If, based on the report of the investigating official under § 355.4(b), the reviewing official determines that there is adequate evidence to believe that a person is liable under § 355.3, the reviewing official shall transmit to the Attorney General a written notice of the reviewing official's intention to issue a complaint under § 355.7. (b) Such notice shall include— (1) A statement of the reviewing official's reasons for issuing a complaint; (2) A statement specifying the evidence that supports the allegations of liability; (3) A description of the claims or statements upon which the allegations of liability are based; (4) An estimate of the amount of money or the value of property, services, or other benefits requested or demanded in violation of § 355.3; (5) A statement of any exculpatory or mitigating circumstances that may relate to the claims or statements known by the reviewing official or the investigating official; and (6) A statement that there is a reasonable prospect of collecting an appropriate amount of penalties and assessments. Such a statement may be based upon information then known or an absence of any information indicating that the person may be unable to pay such an amount. | ||||||
| 20:20:1.0.2.11.62.0.155.6 | 20 | Employees' Benefits | II | E | 355 | PART 355—REGULATIONS UNDER THE ADMINISTRATIVE FALSE CLAIMS ACT | § 355.6 Prerequisites for issuing a complaint. | SSA | (a) The reviewing official may issue a complaint under § 355.7 only if— (1) The Department of Justice approves the issuance of a complaint in a written statement described in 31 U.S.C. 3803(b)(1); and (2) In the case of allegations of liability under § 355.3(a) with respect to a claim, the reviewing official determines that, with respect to such claim or a group of related claims submitted at the same time such claim is submitted (as defined in paragraph (b) of this section), the amount of money or the value of property or services demanded or requested in violation of § 355.3(a) does not exceed $1,000,000. This maximum amount shall be adjusted for inflation in the same manner and to the same extent as civil monetary penalties under the Federal Civil Penalties Inflation Adjustment Act. Notice of the maximum amount under this section for calendar years after 2025 will be published by the authority in the Federal Register on an annual basis on or before January 15 of each calendar year. (b) For the purposes of this section, a related group of claims submitted at the same time shall include only those claims arising from the same transaction ( e.g., grant, loan, application, or contract) that are submitted simultaneously as part of a single request, demand, or submission. (c) Nothing in this section shall be construed to limit the reviewing official's authority to join in a single complaint against a person, claims that are unrelated or were not submitted simultaneously, regardless of the amount of money or the value of property or services demanded or requested. | ||||||
| 20:20:1.0.2.11.62.0.155.7 | 20 | Employees' Benefits | II | E | 355 | PART 355—REGULATIONS UNDER THE ADMINISTRATIVE FALSE CLAIMS ACT | § 355.7 Complaint. | SSA | (a) On or after the date the Department of Justice approves the issuance of a complaint in accordance with 31 U.S.C. 3803(b)(1), the reviewing official may serve a complaint on the respondent, as provided in § 355.8. (b) The complaint shall state— (1) The allegations of liability against the respondent, including the statutory basis for liability, an identification of the claims or statements that are the basis for the alleged liability, and the reasons why liability allegedly arises from such claims or statements; (2) The maximum amount of penalties and assessments for which the respondent may be held liable; (3) Instructions for filing a request for a hearing, including a specific statement of the respondent's right to request a hearing; and (4) That failure to file and answer within 30 days of service of the complaint may result in the imposition of the maximum amount of penalties and assessments without right to appeal. (c) At the same time the reviewing official serves the complaint, he or she shall serve the respondent with a copy of this part. | ||||||
| 20:20:1.0.2.11.62.0.155.8 | 20 | Employees' Benefits | II | E | 355 | PART 355—REGULATIONS UNDER THE ADMINISTRATIVE FALSE CLAIMS ACT | § 355.8 Service of complaint. | SSA | (a) Service of a complaint must be made by certified or registered mail or by delivery in any manner authorized by Rule 4(d) of the Federal Rules of Civil Procedure. (b) Proof of service, stating the name and address of the person on whom the complaint was served, and the manner and date of service, may be made by— (1) Affidavit of the individual making service; (2) An acknowledged U.S. Postal Service return receipt card; or (3) Written acknowledgment of the respondent. | ||||||
| 20:20:1.0.2.11.62.0.155.9 | 20 | Employees' Benefits | II | E | 355 | PART 355—REGULATIONS UNDER THE ADMINISTRATIVE FALSE CLAIMS ACT | § 355.9 Requesting a hearing. | SSA | (a) The respondent may request a hearing by filing the request with the reviewing official within 30 days of service of the complaint. (b) In the request, the respondent— (1) Shall admit or deny each of the allegations of liability made in the complaint; (2) Shall state any defense on which the respondent intends to rely; (3) May state any reasons why the respondent contends that the penalties and assessments should be less than the statutory maximum; and (4) Shall state the name, address, and telephone number of any person authorized by the respondent to act as the respondent's representative. (c) Any other response or document filed with the reviewing official within 30 days of the service of the complaint which does not meet the criteria in paragraph (b) of this section may still be deemed to be a request for hearing, if the reviewing official determines the document demonstrates a clear intent to request a hearing. | ||||||
| 21:21:5.0.1.1.28.1.1.1 | 21 | Food and Drugs | I | D | 355 | PART 355—ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE | A | Subpart A—General Provisions | § 355.1 Scope. | FDA | (a) An over-the-counter anticaries drug product in a form suitable for topical administration to the teeth is generally recognized as safe and effective and is not misbranded if it meets each condition in this part and each general condition established in § 330.1 of this chapter. (b) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted. | ||||
| 21:21:5.0.1.1.28.1.1.2 | 21 | Food and Drugs | I | D | 355 | PART 355—ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE | A | Subpart A—General Provisions | § 355.3 Definitions. | FDA | [60 FR 52507, Oct. 6, 1995, as amended at 61 FR 52286, Oct. 7, 1996] | As used in this part: (a) Abrasive. Solid materials that are added to dentifrices to facilitate mechanical removal of dental plaque, debris, and stain from tooth surfaces. (b) Anhydrous glycerin. An ingredient that may be prepared by heating glycerin U.S.P. at 150 °C for 2 hours to drive off the moisture content. (c) Anticaries drug. A drug that aids in the prevention and prophylactic treatment of dental cavities (decay, caries). (d) Dental caries. A disease of calcified tissues of teeth characterized by demineralization of the inorganic portion and destruction of the organic matrix. (e) Dentifrice. An abrasive-containing dosage form (gel, paste, or powder) for delivering an anticaries drug to the teeth. (f) Fluoride. The inorganic form of the chemical element fluorine in combination with other elements. (g) Fluoride ion. The negatively charged atom of the chemical element fluorine. (h) Fluoride supplement. A special treatment rinse dosage form that is intended to be swallowed, and is promoted to health professionals for use in areas where the water supply contains 0 to 0.7 parts per million (ppm) fluoride ion. (i) Preventive treatment gel. A dosage form for delivering an anticaries drug to the teeth. Preventive treatment gels are formulated in an anhydrous glycerin base with suitable thickening agents included to adjust viscosity. Preventive treatment gels do not contain abrasives. (j) Treatment rinse. A liquid dosage form for delivering an anticaries drug to the teeth. (k) Treatment rinse concentrated solution. A fluoride treatment rinse in a concentrated form to be mixed with water before using to result in the appropriate fluoride concentration specified in the monograph. (l) Treatment rinse effervescent tablets. A fluoride treatment rinse prepared by adding an effervescent tablet (a concentrated solid dosage form) to water before using to result in the appropriate fluoride concentration specified in the monograph. (m) Treatment rinse powder. A fluoride treatment rinse p… | |||
| 21:21:5.0.1.1.28.2.1.1 | 21 | Food and Drugs | I | D | 355 | PART 355—ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE | B | Subpart B—Active Ingredients | § 355.10 Anticaries active ingredients. | FDA | [60 FR 52507, Oct. 6, 1995, as amended at 61 FR 52286, Oct. 7, 1996] | The active ingredient of the product consists of any of the following when used in the concentration and dosage form established for each ingredient: (a) Sodium fluoride —(1) Dentifrices containing 850 to 1,150 ppm theoretical total fluorine in a gel or paste dosage form. Sodium fluoride 0.188 to 0.254 percent with an available fluoride ion concentration ≥650 parts per million (ppm). (2) Dentifrices containing 850 to 1,150 ppm theoretical total fluorine in a powdered dosage form. Sodium fluoride 0.188 to 0.254 percent with an available fluoride ion concentration of ≥850 ppm for products containing the abrasive sodium bicarbonate and a poured-bulk density of 1.0 to 1.2 grams per milliliter. (3) Treatment rinses. (i) An aqueous solution of acidulated phosphate fluoride derived from sodium fluoride acidulated with a mixture of sodium phosphate, monobasic, and phosphoric acid to a level of 0.1 molar phosphate ion and a pH of 3.0 to 4.5 and which yields an effective fluoride ion concentration of 0.02 percent. (ii) An aqueous solution of acidulated phosphate fluoride derived from sodium fluoride acidulated with a mixture of sodium phosphate, dibasic, and phosphoric acid to a pH of 3.5 and which yields an effective fluoride ion concentration of 0.01 percent. (iii) Sodium fluoride 0.02 percent aqueous solution with a pH of approximately 7. (iv) Sodium fluoride 0.05 percent aqueous solution with a pH of approximately 7. (v) Sodium fluoride concentrate containing adequate directions for mixing with water before using to result in a 0.02-percent or 0.05-percent aqueous solution with a pH of approximately 7. (b) Sodium monofluorophosphate —(1) Dentifrices containing 850 to 1,150 ppm theoretical total fluorine in a gel or paste dosage form. Sodium monofluorophosphate 0.654 to 0.884 percent with an available fluoride ion concentration (consisting of PO 3 F = and F − combined) ≥800 ppm. (2) Dentifrices containing 1,500 ppm theoretical total fluorine in a gel or paste dosage form. Sodium monofluorophospha… | |||
| 21:21:5.0.1.1.28.2.1.2 | 21 | Food and Drugs | I | D | 355 | PART 355—ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE | B | Subpart B—Active Ingredients | § 355.20 Packaging conditions. | FDA | (a) Package size limitation. Due to the toxicity associated with fluoride active ingredients, the following package size limitations are required for anticaries drug products: (1) Dentifrices. Dentifrice (toothpastes and tooth powders) packages shall not contain more than 276 milligrams (mg) total fluorine per package. (2) Preventive treatment gels and treatment rinses. Preventive treatment gel and treatment rinse packages shall not contain more than 120 mg total fluorine per package. (3) Exception. Package size limitations do not apply to anticaries drug products marketed for professional office use only and labeled in accord with § 355.60. (b) Tight container packaging. To minimize moisture contamination, all fluoride powdered dentifrices shall be packaged in a tight container as defined as a container that protects the contents from contamination by extraneous liquids, solids, or vapors, from loss of the article, and from efflorescence, deliquescence, or evaporation under the ordinary or customary conditions of handling, shipment, storage, and distribution, and is capable of tight reclosure. | ||||
| 21:21:5.0.1.1.28.3.1.1 | 21 | Food and Drugs | I | D | 355 | PART 355—ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE | C | Subpart C—Labeling | § 355.50 Labeling of anticaries drug products. | FDA | [60 FR 52507, Oct. 6, 1995; 60 FR 57927, Nov. 24, 1995; 61 FR 51187, Oct. 7, 1996; 64 FR 13296, Mar. 17, 1999] | (a) Statement of identity. The labeling of the product contains the established name of the drug, if any, and identifies the product as: (select one or both of the following: ‘anticavity’ or ‘fluoride’) (select one of the following as appropriate: “dentifrice,” “toothpaste,” “tooth polish,” “tooth powder;” (optional: “dental”) “preventive treatment gel;” or (optional: “treatment” or “dental”)) (select one of the following: “rinse,” “concentrated solution,” “rinse powder,” or “rinse effervescent tablets”). The word “mouthwash” may be substituted for the word “rinse” in this statement of identity if the product also has a cosmetic use, as defined in section 201(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321(i)). (b) Indication. The labeling of the product states, under the heading “Indication,” the following: “Aids in the prevention of dental (select one of the following: “cavities,” “decay,” “caries (decay),” or “caries (cavities)”). Other truthful and nonmisleading statements, describing only the indication for use that has been established and listed in this paragraph (b), may also be used, as provided in § 330.1(c)(2) of this chapter, subject to the provisions of section 502 of the Federal Food, Drug, and Cosmetic Act (the act) relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act. (c) Warning. The labeling of the product contains the following warning under the heading “Warning”: (1) For all fluoride dentifrice (gel, paste, and powder) products. “Keep out of reach of children under 6 years of age. [highlighted in bold type] If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.” These warnings shall be used in place of the general warning statements required by § 330.1(g) of this chapter. (2) For all fluoride rinse and preventive treatment gel pr… | |||
| 21:21:5.0.1.1.28.3.1.2 | 21 | Food and Drugs | I | D | 355 | PART 355—ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE | C | Subpart C—Labeling | § 355.55 Principal display panel of all fluoride rinse drug products. | FDA | In addition to the statement of identity required in § 355.50, the following statement shall be prominently placed on the principal display panel: “IMPORTANT: Read directions for proper use.” | ||||
| 21:21:5.0.1.1.28.3.1.3 | 21 | Food and Drugs | I | D | 355 | PART 355—ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE | C | Subpart C—Labeling | § 355.60 Professional labeling. | FDA | (a) The labeling for anticaries fluoride treatment rinses identified in § 355.10(a)(3) and (c)(3) that are specially formulated so they may be swallowed (fluoride supplements) and are provided to health professionals (but not to the general public) may contain the following additional dosage information: Children 3 to under 14 years of age: As a supplement in areas where the water supply is nonfluoridated (less than 0.3 parts per million (ppm)), clean the teeth with a toothpaste and rinse with 5 milliliters (mL) of 0.02 percent or 10 mL of 0.01 percent fluoride ion rinse daily, then swallow. When the water supply contains 0.3 to 0.7 ppm fluoride ion, reduce the dose to 2.5 mL of 0.02 percent or 5 mL of 0.01 percent fluoride ion rinse daily. (b) The labeling for products marketed to health to health professionals in package sizes larger than those specified in § 355.20 shall include the statements: “For Professional Office Use Only” and “This product is not intended for home or unsupervised consumer use.” | ||||
| 21:21:5.0.1.1.28.4.1.1 | 21 | Food and Drugs | I | D | 355 | PART 355—ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE | D | Subpart D—Testing Procedures | § 355.70 Testing procedures for fluoride dentifrice drug products. | FDA | [60 FR 52507, Oct. 6, 1995, as amended at 68 FR 24879, May 9, 2003; 88 FR 45066, July 14, 2023] | (a) A fluoride dentifrice drug product shall meet the biological test requirements for animal caries reduction and one of the following tests: Enamel solubility reduction or fluoride enamel uptake. The testing procedures for these biological tests are labeled Biological Testing Procedures for Fluoride Dentifrices ; these testing procedures are on file under Docket No. 80N-0042 in the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and are available on request to that office. (b) The United States Pharmacopeia fluoride dentifrice reference standards along with reference standard stability profiles (total fluoride, available fluoride ion, pH, and specific gravity) required to be used in the biological tests are available to any purchaser upon written request to the United States Pharmacopeial Convention, Inc., 1260 Twinbrook Parkway, Rockville, MD 20852. (c) Alternative testing procedures may be used. Any proposed modification or alternative testing procedures shall be submitted as a petition in accord with § 10.30 of this chapter. The petition should contain data to support the modification or data demonstrating that an alternative testing procedure provides results of equivalent accuracy. All information submitted will be subjected to the disclosure rules in part 20 of this chapter. | |||
| 40:40:30.0.1.1.11.1.13.1 | 40 | Protection of Environment | I | J | 355 | PART 355—EMERGENCY PLANNING AND NOTIFICATION | A | Subpart A—General Information | § 355.1 What is the purpose of this part? | EPA | (a) This part (40 CFR part 355) establishes requirements for a facility to provide information necessary for developing and implementing State and local chemical emergency response plans, and requirements for emergency notification of chemical releases. This part also lists Extremely Hazardous Substances (EHSs) and Threshold Planning Quantities (TPQs) in Appendices A and B, which are used in determining if you are subject to these requirements. (b) This part is written in a special format to make it easier to understand the regulatory requirements. Like other Environmental Protection Agency (EPA) regulations, this part establishes enforceable legal requirements. Information considered non-binding guidance under EPCRA is indicated in this regulation by the word “note” and a smaller typeface. Such notes are provided for information purposes only and are not considered legally binding under this part. | ||||
| 40:40:30.0.1.1.11.1.13.2 | 40 | Protection of Environment | I | J | 355 | PART 355—EMERGENCY PLANNING AND NOTIFICATION | A | Subpart A—General Information | § 355.2 Who do “you,” “I,” and “your” refer to in this part? | EPA | Throughout this part, “you,” “I,” and “your” refer to the owner or operator of a facility. | ||||
| 40:40:30.0.1.1.11.1.13.3 | 40 | Protection of Environment | I | J | 355 | PART 355—EMERGENCY PLANNING AND NOTIFICATION | A | Subpart A—General Information | § 355.3 Which section contains the definitions of the key words used in this part? | EPA | The definitions of key words used in this part are in § 355.61. It is important to read the definitions for these key words because the definition explains the word's specific meaning associated with the regulations in this part. | ||||
| 40:40:30.0.1.1.11.2.13.1 | 40 | Protection of Environment | I | J | 355 | PART 355—EMERGENCY PLANNING AND NOTIFICATION | B | Subpart B—Emergency Planning | § 355.10 Must my facility comply with the emergency planning requirements of this subpart? | EPA | You must comply with the emergency planning requirements in this subpart if your facility meets either of the following two conditions: (a) Any extremely hazardous substance (EHS) is present at your facility in an amount equal to or greater than its threshold planning quantity (TPQ), or (b) Your facility has been designated for emergency planning purposes, after public notice and opportunity for comment, by one of the following three entities: (1) The State Emergency Response Commission (SERC). (2) The Governor of the State in which your facility is located. (3) The Chief Executive Officer of the Tribe for the Indian Tribe under whose jurisdiction your facility is located. | ||||
| 40:40:30.0.1.1.11.2.13.2 | 40 | Protection of Environment | I | J | 355 | PART 355—EMERGENCY PLANNING AND NOTIFICATION | B | Subpart B—Emergency Planning | § 355.11 To what substances do the emergency planning requirements of this subpart apply? | EPA | The emergency planning requirements of this subpart apply to any EHS listed in Appendices A and B of this part. Additionally, if a facility is designated for emergency planning purposes, as provided in § 355.10(b), substances that are not EHSs at this facility may become subject to the emergency planning requirements. | ||||
| 40:40:30.0.1.1.11.2.13.3 | 40 | Protection of Environment | I | J | 355 | PART 355—EMERGENCY PLANNING AND NOTIFICATION | B | Subpart B—Emergency Planning | § 355.12 What quantities of extremely hazardous substances trigger emergency planning requirements? | EPA | Any EHS present at your facility in an amount equal to or greater than its TPQ triggers the emergency planning requirements of this subpart. The TPQs are listed in Appendices A and B of this part in the column labeled “threshold planning quantity.” | ||||
| 40:40:30.0.1.1.11.2.13.4 | 40 | Protection of Environment | I | J | 355 | PART 355—EMERGENCY PLANNING AND NOTIFICATION | B | Subpart B—Emergency Planning | § 355.13 How do I calculate the quantity of an extremely hazardous substance present in mixtures? | EPA | If an EHS is present in a mixture in a particular container, determine the quantity (in pounds) of the EHS in that container by multiplying the concentration of the EHS (in weight percent) by the weight (in pounds) of the mixture in the container. If the concentration of an EHS is less than or equal to one percent in the mixture, you do not have to count that EHS. Here is an example calculation: EHS (in pounds) = (weight percent of EHS) × (weight of mixture) = (20 percent) × (150 pound mixture) = (0.20) × (150) EHS (in pounds) = 30 pounds | ||||
| 40:40:30.0.1.1.11.2.13.5 | 40 | Protection of Environment | I | J | 355 | PART 355—EMERGENCY PLANNING AND NOTIFICATION | B | Subpart B—Emergency Planning | § 355.14 Do I have to aggregate extremely hazardous substances to determine the total quantity present? | EPA | You must aggregate ( i.e. , add together) the amounts of each EHS at your facility to determine if a TPQ is present. This means that, for a particular EHS, you must determine the total amount present at any one time at your facility by adding together the quantity of pure EHS and the quantity contained in all mixtures, regardless of location, number of containers, or method of storage. You do not have to count an EHS in a mixture if the concentration of that EHS is less than or equal to one percent. | ||||
| 40:40:30.0.1.1.11.2.13.6 | 40 | Protection of Environment | I | J | 355 | PART 355—EMERGENCY PLANNING AND NOTIFICATION | B | Subpart B—Emergency Planning | § 355.15 Which threshold planning quantity do I use for an extremely hazardous substance present at my facility in solid form? | EPA | EHSs that are in solid form are subject to one of two different TPQs (for example, TPQs may be listed as 500/10,000 pounds), both of which are listed in Appendices A and B of this part. Here is how to determine which of the two listed TPQs you must use for an EHS present at your facility in solid form: (a) Use the lower TPQ from Appendices A and B of this part if the solid: (1) Is in powdered form and has a particle size less than 100 microns; (2) Is in solution; (3) Is in molten form; or (4) Meets the criteria for a National Fire Protection Association (NFPA) rating of 2, 3 or 4 for reactivity. Use the instructions in § 355.16 to calculate the quantity present for the categories of solids listed in paragraphs (a)(1), (2) and (3) of this section. (b) If the solid does not meet one of the criteria in paragraph (a) of this section, then the TPQ is 10,000 pounds. | ||||
| 40:40:30.0.1.1.11.2.13.7 | 40 | Protection of Environment | I | J | 355 | PART 355—EMERGENCY PLANNING AND NOTIFICATION | B | Subpart B—Emergency Planning | § 355.16 How do I determine the quantity of extremely hazardous substances present for certain forms of solids? | EPA | [73 FR 65462, Nov. 3, 2008, as amended at 77 FR 16688, Mar. 22, 2012] | For the three forms of solids that are listed in § 355.15(a)(1) through (3), use these instructions to determine the quantity of extremely hazardous substance present: (a) Solid in powdered form with a particle size less than 100 microns. Multiply the weight percent of solid with a particle size less than 100 microns in a particular container by the total weight of solid in the container. (b) Solid in solution. Multiply the weight percent of the non-reactive solid in solution in a particular container by the total weight of solution in that container. Then multiply by 0.2. This reduction in quantity must not be used to determine the amount present at one-time at a facility for reporting under 40 CFR 370.10. (c) Solid in molten form. Multiply the weight of the non-reactive solid in molten form by 0.3. This reduction in quantity must not be used to determine the amount present at one-time at a facility for reporting under 40 CFR 370.10. | |||
| 40:40:30.0.1.1.11.2.14.8 | 40 | Protection of Environment | I | J | 355 | PART 355—EMERGENCY PLANNING AND NOTIFICATION | B | Subpart B—Emergency Planning | § 355.20 If this subpart applies to my facility, what information must I provide, who must I submit it to, and when is it due? | EPA | Use this table to determine the information you must provide, who to provide it to, and when: | ||||
| 40:40:30.0.1.1.11.2.14.9 | 40 | Protection of Environment | I | J | 355 | PART 355—EMERGENCY PLANNING AND NOTIFICATION | B | Subpart B—Emergency Planning | § 355.21 In what format should the information be submitted? | EPA | EPA does not require any specific format. EPA recommends that you submit the information described in § 355.20 in writing in order to insure appropriate documentation. The SERC or LEPC may request that this information be submitted in a specific format. | ||||
| 40:40:30.0.1.1.11.3.15.1 | 40 | Protection of Environment | I | J | 355 | PART 355—EMERGENCY PLANNING AND NOTIFICATION | C | Subpart C—Emergency Release Notification | § 355.30 What facilities must comply with the emergency release notification requirements of this subpart? | EPA | You must comply with the emergency release notification requirements in this subpart if both of these two conditions are met: (a) You produce, use, or store a hazardous chemical at your facility; and (b) You release a reportable quantity (RQ) of any EHS or of a hazardous substance as defined by the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA Hazardous Substance) at your facility. Certain releases are exempted from these requirements. Exempted releases are listed in § 355.31. In addition to the emergency release notification requirements of this subpart, releases of CERCLA hazardous substances are subject to the notification requirements under CERCLA. This is explained further in subpart D of this part. | ||||
| 40:40:30.0.1.1.11.3.15.2 | 40 | Protection of Environment | I | J | 355 | PART 355—EMERGENCY PLANNING AND NOTIFICATION | C | Subpart C—Emergency Release Notification | § 355.31 What types of releases are exempt from the emergency release notification requirements of this subpart? | EPA | [73 FR 65462, Nov. 3, 2008, as amended at 73 FR 76960, Dec. 18, 2008; 83 FR 37446, Aug. 1, 2018; 84 FR 27452, June 13, 2019] | You do not have to provide emergency release notification under this subpart for any of the following six types of releases of EHSs or CERCLA hazardous substances that occur at your facility: (a) Any release that results in exposure to persons solely within the boundaries of your facility. (b) Any release that is a federally permitted release as defined in section 101(10) of CERCLA. (c) Any release of a pesticide product that is exempt from reporting under section 103(e) of CERCLA. (d) Any release that does not meet the definition of release under section 101(22) of CERCLA and is therefore exempt from CERCLA section 103(a) reporting. (e) Any radionuclide release that occurs: (1) Naturally in soil from land holdings such as parks, golf courses, or other large tracts of land. (2) Naturally from land disturbance activities, including farming, construction, and land disturbance incidental to extraction during mining activities, except that which occurs at uranium, phosphate, tin, zircon, hafnium, vanadium, monazite, and rare earth mines. Land disturbance incidental to extraction includes: Land clearing; overburden removal and stockpiling; excavating, handling, transporting, and storing ores and other raw (not beneficiated or processed) materials; and replacing in mined-out areas coal ash, earthen materials from farming or construction, or overburden or other raw materials generated from the exempted mining activities. (3) From the dumping and transportation of coal and coal ash (including fly ash, bottom ash, and boiler slags), including the dumping and land spreading operations that occur during coal ash uses. (4) From piles of coal and coal ash, including fly ash, bottom ash, and boiler slags. (f) Any release less than 1,000 pounds per 24 hours of nitrogen oxide or nitrogen dioxide to the air which is the result of combustion and combustion related activities. (g) Air emissions from animal waste (including decomposing animal waste) at a farm. | |||
| 40:40:30.0.1.1.11.3.15.3 | 40 | Protection of Environment | I | J | 355 | PART 355—EMERGENCY PLANNING AND NOTIFICATION | C | Subpart C—Emergency Release Notification | § 355.32 Which emergency release notification requirements apply to continuous releases? | EPA | If the release of an EHS or CERCLA hazardous substance is continuous and stable in quantity and rate at your facility as defined in 40 CFR 302.8(b), then the release qualifies for reduced reporting requirements under this subpart. Under these reduced reporting requirements, you do not need to provide the notifications required under § 355.40. However, in addition to the notifications required under 40 CFR 302.8, you must make all of the following notifications to the community emergency coordinator for the LEPC for any area likely to be affected by the release and to the SERC of any State likely to be affected by the release: (a) Initial notifications as specified in 40 CFR 302.8 (d) and (e). (b) Notification of a “statistically significant increase,” defined in 40 CFR 302.8(b) as any increase above the upper bound of the reported normal range. (c) Notification of a “new release” as specified in 40 CFR 302.8(g)(1). (d) Notification of a change in the normal range of the release as specified under 40 CFR 302.8(g)(2). | ||||
| 40:40:30.0.1.1.11.3.15.4 | 40 | Protection of Environment | I | J | 355 | PART 355—EMERGENCY PLANNING AND NOTIFICATION | C | Subpart C—Emergency Release Notification | § 355.33 What release quantities of EHSs and CERCLA hazardous substances trigger the emergency release notification requirements of this subpart? | EPA | The release of a reportable quantity (RQ) of an EHS or CERCLA hazardous substance within any 24-hour period triggers the emergency release notification requirements. RQs for EHSs are listed in Appendices A and B of this part in the column labeled “reportable quantity.” RQs for CERCLA hazardous substances are listed in Table 302.4 of 40 CFR 302.4 in the column labeled “final RQ.” | ||||
| 40:40:30.0.1.1.11.3.16.5 | 40 | Protection of Environment | I | J | 355 | PART 355—EMERGENCY PLANNING AND NOTIFICATION | C | Subpart C—Emergency Release Notification | § 355.40 What information must I provide? | EPA | You must make two separate notifications to comply with the emergency release notification requirements of this subpart: an immediate notification, and as soon as practicable thereafter a written follow-up emergency notification (or notifications, as more information becomes available). (a) Immediate notification. The notice required under this section shall include as much of the following information known at the time. However, the retrieval of this information should not cause a delay in the notification on the emergency response. (1) The chemical name or identity of any substance involved in the release. (2) Indicate whether the substance is an EHS. (3) Provide an estimate of the quantity of any such substance that was released into the environment. (4) State the time and duration of the release. (5) The medium or media into which the release occurred. (6) Any known or anticipated acute or chronic health risks associated with the emergency and, where appropriate, advice regarding medical attention necessary for exposed individuals. (7) Proper precautions to take as a result of the release, including evacuation (unless such information is readily available to the community emergency coordinator pursuant to the emergency plan). (8) The name and telephone number of the individual (or individuals) to be contacted for further information. (b) Written follow-up emergency notification. Except for releases that occur during transportation or from storage incident to transportation, you must provide a written follow-up emergency notice (or notices, as more information becomes available), as soon as practicable after the release. In the written follow-up emergency notice, you must provide and update the information required in the immediate notification and include additional information with respect to all of the following: (1) Actions taken to respond and contain the release. (2) Any known or anticipated acute or chronic health risks associated with the release. (3) Where appropriate, advice regardin… | ||||
| 40:40:30.0.1.1.11.3.16.6 | 40 | Protection of Environment | I | J | 355 | PART 355—EMERGENCY PLANNING AND NOTIFICATION | C | Subpart C—Emergency Release Notification | § 355.41 In what format should the information be submitted? | EPA | [73 FR 65462, Nov. 3, 2008, as amended at 85 FR 44772, July 24, 2020] | The immediate notification, described in § 355.40(a), should be oral. The follow-up emergency notification, described in § 355.40(b), shall be in writing. EPA does not specify a particular format for the written follow-up emergency notification. The SERC and LEPC may request a specific format for this information. | |||
| 40:40:30.0.1.1.11.3.16.7 | 40 | Protection of Environment | I | J | 355 | PART 355—EMERGENCY PLANNING AND NOTIFICATION | C | Subpart C—Emergency Release Notification | § 355.42 To whom must I submit the information? | EPA | (a) You must provide the immediate emergency release notification information and the written follow-up notification to: (1) The community emergency coordinator for the LEPC of any area likely to be affected by the release (if there is no LEPC, notify the relevant local emergency response personnel); and (2) The SERC of any State likely to be affected by the release. (b) For a release that occurs during transportation or from storage incident to transportation, you may meet the requirements of this subpart by notifying the 911 operator (or in the absence of a 911 emergency telephone number, the operator) of the immediate notification information listed in § 355.40(a). You are not required under this subpart to submit a written follow-up notification, as described in § 355.40(b), for such a release. | ||||
| 40:40:30.0.1.1.11.3.16.8 | 40 | Protection of Environment | I | J | 355 | PART 355—EMERGENCY PLANNING AND NOTIFICATION | C | Subpart C—Emergency Release Notification | § 355.43 When must I submit the information? | EPA | (a) You must provide the required emergency release notification information described under § 355.40(a), immediately. (b) You must provide the written follow-up emergency notice (or notices, as more information becomes available) described under § 355.40(b), as soon as practicable after the release. | ||||
| 40:40:30.0.1.1.11.4.17.1 | 40 | Protection of Environment | I | J | 355 | PART 355—EMERGENCY PLANNING AND NOTIFICATION | D | Subpart D—Additional Provisions | § 355.60 What is the relationship between the emergency release notification requirements of this part and the release notification requirements of CERCLA? | EPA | The emergency release notification requirements of this part are in addition to the release notification requirements of CERCLA. If you have a release of a CERCLA hazardous substance, you must comply with the emergency release notification requirements of this part and the release notification requirements of CERCLA section 103, codified at 40 CFR part 302. Use this table to determine which emergency release notification requirements apply to your release: Note: This table only applies to reportable releases, not to exempt releases. | ||||
| 40:40:30.0.1.1.11.4.17.2 | 40 | Protection of Environment | I | J | 355 | PART 355—EMERGENCY PLANNING AND NOTIFICATION | D | Subpart D—Additional Provisions | § 355.61 How are key words in this part defined? | EPA | [73 FR 65462, Nov. 3, 2008, as amended at 73 FR 76960, Dec. 18, 2008; 77 FR 16688, Mar. 22, 2012; 83 FR 37466, Aug. 1, 2018; 84 FR 27542, June 13, 2019] | Animal waste means feces, urine, or other excrement, digestive emission, urea, or similar substances emitted by animals (including any form of livestock, poultry, or fish). This term includes animal waste that is mixed or commingled with bedding, compost, feed, soil, or any other material typically found with such waste. CERCLA means the Comprehensive Environmental Response, Compensation and Liability Act of 1980, as amended. CERCLA hazardous substance means a substance defined in section 101(14) of CERCLA and listed in Table 302.4 of 40 CFR 302.4. Chief Executive Officer of the Tribe means the person who is recognized by the Bureau of Indian Affairs as the chief elected administrative officer of the Tribe. Environment includes water, air, and land and the interrelationship that exists among and between water, air, and land and all living things. EPCRA means the Emergency Planning and Community Right-To-Know Act of 1986. Extremely hazardous substance (EHS) means a substance listed in Appendices A and B of this part. Facility means all buildings, equipment, structures, and other stationary items that are located on a single site or on contiguous or adjacent sites and that are owned or operated by the same person (or by any person that controls, is controlled by, or under common control with, such person). Facility includes manmade structures, as well as all natural structures in which chemicals are purposefully placed or removed through human means such that it functions as a containment structure for human use. For purposes of emergency release notification, the term includes motor vehicles, rolling stock, and aircraft. Farm means a site or area (including associated structures) that— (1) Is used for— (i) The production of a crop; or (ii) The raising or selling of animals (including any form of livestock, poultry, or fish); and (2) Under normal conditions, produces during a farm year any agricultural products with a total value equal to not less than $1,000. Hazardous chemical means any h… | |||
| 46:46:8.0.1.11.33.0.12.1 | 46 | Shipping | II | J | 355 | PART 355—REQUIREMENTS FOR ESTABLISHING UNITED STATES CITIZENSHIP | § 355.1 General. | FMC | [G.O. 89, Rev., 35 FR 11558, July 18, 1970, as amended at 68 FR 62538, Nov. 5, 2003; 69 FR 34311, June 21, 2004; 69 FR 61451, Oct. 19, 2004] | (a) Under section 2, Shipping Act, 1916, as amended and section 905(c), Merchant Marine Act, 1936, as amended, no corporation is deemed to be a citizen of the United States unless: (1) It is organized under the laws of the United States or of a State, Territory, District, or possession thereof; (2) Its chief executive officer, by whatever title, and the chairman of its board of directors are citizens of the United States, and no more of its directors than a minority of the number necessary to constitute a quorum are non-citizens (except that in the case of corporations under title VI, Merchant Marine Act, 1936, as amended, all directors must be citizens of the United States) and (3) The controlling interest therein is owned by citizens of the United States or, in the case of a corporation operating any vessel in the coastwise trade, on the Great Lakes, or inland lakes of the United States, 75 per centum of the interest in such corporation is owned by citizens of the United States. (b) As used in this part, the term “primary corporation” includes, but not exclusively, an applicant, for, or one already receiving, benefits under the Merchant Marine Act, 1936, as amended, as well as participants in certain transactions, such as banking institutions designated as lenders, mortgagees, and trustees pursuant to Public Law 89-346 (73 Stat. 597), as amended. (c) To satisfy the statutory requirements, an Affidavit of U.S. Citizenship of a primary corporation by one of its officers duly authorized to execute such Affidavit, should be submitted. This affidavit should contain facts from which the corporation's citizenship can be determined. MARAD will accept electronic options (such as facsimile and Internet) for transmission of required information to MARAD, if practicable. | |||||
| 46:46:8.0.1.11.33.0.12.2 | 46 | Shipping | II | J | 355 | PART 355—REQUIREMENTS FOR ESTABLISHING UNITED STATES CITIZENSHIP | § 355.2 Requirements regarding evidence of U.S. citizenship; affidavit guide. | FMC | [G.O. 89, Rev., 35 FR 11558, July 18, 1970, as amended at 35 FR 11686, July 22, 1970; 47 FR 25530, June 14, 1982; 69 FR 34311, June 21, 2004] | (a) In order to establish that a corporation is a citizen of the United States within the meaning of section 2, Shipping Act, 1916, as amended, the form of affidavit to be used as a guide is hereby prescribed for execution in behalf of the primary corporation and filing with an application or, if required, subsequent filing within 30 days after the annual meeting of the stockholders (if the primary corporation is a wholly owned subsidiary and contrary to the bylaw provision does not hold the annual meeting of stockholders, the subsequent filing should be annually and related to the date of the original filing) as evidence of the continuing U.S. citizenship of a “person” as defined in section 1, Shipping Act, 1916, as amended, which shall read as follows: Affidavit of U.S. Citizenship State of ______ County of ______ SS: I, __________, (Name) of __________, (Residence address) being duly sworn, depose and say: 1. That I am the ______(Title of office(s) held) of ______, (Name of corporation) a corporation organized and existing under the laws of the State of ______ (hereinafter called the “Corporation”), with offices at __________, (Business address) in evidence of which incorporation a certified copy of the Articles or Certificate of Incorporation (or Association) is filed herewith (or has been filed) together with a certified copy of the corporate Bylaws. [Evidence of continuing U.S. citizenship status, including amendments to said Articles or Certificate and Bylaws, should be filed within 30 days after the annual meeting of the stockholders or annually, within 30 days after the original affidavit if there has been no meeting of the stockholders prior to that time.]; 2. That I am authorized by and in behalf of the Corporation to execute and deliver this Affidavit of U.S. Citizenship; 3. That the names of the Chief Executive Officer, by whatever title, Vice Presidents or other individuals who are authorized to act in the absence or disability of the Chief Executive Officer, by whatever title, the C… | |||||
| 46:46:8.0.1.11.33.0.12.3 | 46 | Shipping | II | J | 355 | PART 355—REQUIREMENTS FOR ESTABLISHING UNITED STATES CITIZENSHIP | § 355.3 Criteria to be applied in support of stock data in affidavit. | FMC | (a) The same criteria should be observed in obtaining information to be furnished for stockholders named (direct ownership of required percentage of shares of stock of each class or series) in the Affidavit as those observed for the primary corporation. If, on the other hand, the “fair inference rule” is applied with respect to stock ownership (see Collier Advertising Service, Inc. v. Hudson River Day Line, 14 Fed. Supp. 335), the extent of U.S. citizen ownership of stock should be ascertained in the requisite percentage (65 percent for foreign operation and 95 percent for coastwise operation) in order that the veracity of the statutory statements made in the Affidavit (paragraph 5) may be relied upon by the Maritime Administration. (b) When applying the fair inference rule (where there are more than 30 stockholders, except where one or more of such number actually owns the controlling or 75 percent interest) in order to prove U.S. citizen ownership in the required percentages (1) for foreign operation, 65 percent of the shares of stock of each class or series must be shown to be held by persons with registered addresses within the United States to prove that 51 percent or controlling interest is vested in citizens of the United States and (2) for coastwise operation, 95 percent of the shares of stock of each class or series must be shown to be held by persons having registered addresses within the United States to prove that 75 percent of the interest in the corporation is vested in citizens of the United States. (c) If the primary corporation is consecutively owned by several “parent” corporations (holders of 100 percent of the stock of each or all classes or series of stock issued and outstanding), the facts should be given in proper sequence either by chart or in narrative form, revealing the facts of stock ownership. The information with respect to the ultimate parent should include data relative to the basis upon which controlling or 75 percent (depending upon whether the primary corporation operates in t… | ||||||
| 46:46:8.0.1.11.33.0.12.4 | 46 | Shipping | II | J | 355 | PART 355—REQUIREMENTS FOR ESTABLISHING UNITED STATES CITIZENSHIP | § 355.4 Changes in citizenship data. | FMC | It shall be incumbent upon the parties filing affidavits under this part to apprise the Maritime Administration promptly in writing relative to changes in data last furnished with respect to officers, directors, and stockholders holding 5 percent or more of the issued and outstanding stock of each class or series, together with statements concerning the citizenship status thereof. | ||||||
| 46:46:8.0.1.11.33.0.12.5 | 46 | Shipping | II | J | 355 | PART 355—REQUIREMENTS FOR ESTABLISHING UNITED STATES CITIZENSHIP | § 355.5 Additional material. | FMC | If additional material is determined to be essential to clarify or support the evidence of U.S. citizenship, such material shall be furnished by the aforementioned primary corporation upon request by the Maritime Administration. | ||||||
| 7:7:5.1.1.1.15.1.47.1 | 7 | Agriculture | III | 355 | PART 355—ENDANGERED SPECIES REGULATIONS CONCERNING TERRESTRIAL PLANTS | A | Subpart A—Purpose and Definitions | § 355.1 Purpose. | APHIS | [66 FR 21060, Apr. 27, 2001] | Pursuant to the Endangered Species Act of 1973, as amended (16 U.S.C. 1531 et seq. ), the Secretary is responsible for the enforcement of the provisions of the Act and Convention that pertain to the importation, exportation, or reexportation of terrestrial plants. 1 The regulations in this part are for the purpose of implementing this authority. Regulations of the U.S. Department of the Interior that correlate with the regulations in this part are contained in 50 CFR chapter I. 2 1 Under section 11 of the Act (16 U.S.C. 1540), it is unlawful for any person to knowingly violate any provision of the Act, any permit or certificate issued under the Act, or any regulation promulgated under the Act. Section 11 of the Act also provides for criminal, civil, and administrative penalties for any such violation. 2 Plant Protection and Quarantine also administers programs under the Lacey Act Amendments of 1981, as amended (16 U.S.C. 3371 through 3378), 7 U.S.C. 2814, and the Plant Protection Act (7 U.S.C. 7701-7772), which authorize additional prohibitions and restrictions on the importation of plants subject to this part (see other parts of 7 CFR chapter III for regulations containing prohibitions and restrictions under these authorities). | ||||
| 7:7:5.1.1.1.15.1.47.2 | 7 | Agriculture | III | 355 | PART 355—ENDANGERED SPECIES REGULATIONS CONCERNING TERRESTRIAL PLANTS | A | Subpart A—Purpose and Definitions | § 355.2 Definitions. | APHIS | [49 FR 42912, Oct. 25, 1984, as amended at 70 FR 57995, Oct. 5, 2005] | Terms used in the singular form in this part shall be construed as the plural, and vice versa, as the case may demand. The following terms, when used in this part, shall be construed, respectively, to mean: Act. The Endangered Species Act of 1973, as amended (16 U.S.C. 1531 et seq. ). Convention. The Convention on International Trade in Endangered Species of Wild Fauna and Flora, TIAS 8249, 27 U.S.T. 1087, signed on March 3, 1973, and the Appendices thereto. Deputy Administrator. The Deputy Administrator of the Animal and Plant Health Inspection Service for Plant Protection and Quarantine, U.S. Department of Agriculture, or any other officer or employee of the Department to whom authority to act in his or her stead has been or may hereafter be delegated. Engage in business as an importer, exporter, or reexporter of terrestrial plants. To import, export, or reexport terrestrial plants for the purpose of selling, bartering, collecting, or otherwise exchanging or acquiring the plants as a livelihood or enterprise engaged in for gain or profit. This term shall not include persons engaged in business merely as carriers or customhouse brokers. Export (exported, exporting, exportation). To carry, send, take, transport or otherwise remove, or to attempt to carry, send, take, transport or otherwise remove from any place subject to the jurisdiction of the United States. Import (imported, importing, importation). To land on, bring into, or introduce into, or attempt to land on, bring into, or introduce into, any place subject to the jurisdiction of the United States, whether or not such landing, bringing, or introduction constitutes an importation within the meaning of the customs laws of the United States. Inspector. Any employee of Plant Protection and Quarantine, Animal and Plant Health Inspection Service, U.S. Department of Agriculture, or other person, authorized by the Deputy Administrator in accordance with law to enforce the provisions of the Act and Convention, and regulations promulgated thereunder.… | ||||
| 7:7:5.1.1.1.15.2.47.1 | 7 | Agriculture | III | 355 | PART 355—ENDANGERED SPECIES REGULATIONS CONCERNING TERRESTRIAL PLANTS | B | Subpart B—Permission to Engage in Business | § 355.10 Permission to engage in business concerning nonlisted terrestrial plants. | APHIS | [49 FR 42912, Oct. 25, 1984, as amended at 70 FR 57995, Oct. 5, 2005] | The Secretary hereby grants permission for any person engaged in business as an importer, exporter, or reexporter of terrestrial plants, other than terrestrial plants listed in 50 CFR 17.12 or 23.23, to engage in such business without a protected plant permit issued under § 355.11. | ||||
| 7:7:5.1.1.1.15.2.47.2 | 7 | Agriculture | III | 355 | PART 355—ENDANGERED SPECIES REGULATIONS CONCERNING TERRESTRIAL PLANTS | B | Subpart B—Permission to Engage in Business | § 355.11 Protected plant permits. | APHIS | [49 FR 42912, Oct. 25, 1984, as amended at 59 FR 67611, Dec. 30, 1994; 66 FR 21060, Apr. 27, 2001; 70 FR 57995, Oct. 5, 2005] | (a) On or after March 26, 1985 no person shall engage in business as an importer, exporter, or reexporter of any terrestrial plants listed in 50 CFR 17.12 or 23.23 unless such person has obtained a protected plant permit for engaging in such business from Plant Protection and Quarantine. (b) An application for a protected plant permit shall be submitted to the Animal and Plant Health Inspection Service, Plant Protection and Quarantine, Permit Services, 4700 River Road Unit 133, Riverdale, MD 20737-1236. The completed application shall include the following information: 3 3 Application forms are available on the Internet ( http://www.aphis.usda.gov/ppq/permits ), by calling (877) 770-5990, or by writing to the address in this paragraph. Application forms may also be obtained from local offices at any of the ports designated in 50 CFR part 24. Telephone numbers and addresses of local offices are listed in telephone directories. (1) Date of application; (2) Applicant's name, mailing address, and telephone number; (3) If the applicant is an individual, the business affiliation, if any, having to do with the importation, exportation, or reexportation of terrestrial plants listed in 50 CFR 17.12 or 23.23; (4) If the applicant is in the name of a business or if the applicant is affiliated with a business which imports, exports, or reexports terrestrial plants listed in 50 CFR 17.12 or 23.23, the form of the business, e.g., corporation, firm, partnership; and the name and address of each partner, officer, director, holder, and owner of 10 percent or more of the voting stock, and employee in a managerial or executive capacity; (5) The address of all applicants' business locations, including but not limited to locations of nurseries, growing fields, propagating beds, holding beds and similar facilities where activities relating to terrestrial plants listed in 50 CFR 17.12 or 23.23 would be conducted; (6) A brief and complete description of the nature of the applicant's business as it relates to engaging in busin… | ||||
| 7:7:5.1.1.1.15.3.47.1 | 7 | Agriculture | III | 355 | PART 355—ENDANGERED SPECIES REGULATIONS CONCERNING TERRESTRIAL PLANTS | C | Subpart C—Inspections and Related Provisions | § 355.20 Marketing and notification requirements for plants imported, exported, or reexported by means other than mail. | APHIS | [49 FR 42912, Oct. 25, 1984, as amended at 70 FR 57995, Oct. 5, 2005] | 4 Certain terrestrial plants listed in Appendices I, II, or III of the Convention or determined by the U.S. Department of the Interior to be endangered or threatened or similar in appearance to endangered or threatened species are required to be accompanied by documentation at the time of importation, exportation, or reexportation (see 50 CFR chapter I). Plants are allowed to be imported, exported or reexported only at ports authorized for such purposes by the U.S. Department of the Interior, or, under certain circumstances as determined by the U.S. Department of the Interior, at nondesignated ports, pursuant to section 9(f) of the Act (16 U.S.C. 1538(f)). (see 50 CFR part 24 for a list of designated ports.) (a) Any terrestrial plant which is to be imported, exported, or reexported by means other than mail and which may be imported, exported, or reexported under 50 CFR part 17 or part 23 only if accompanied by documentation, shall at the time of importation, exportation, or reexportation plainly and correctly bear on the outer container or on a tag, invoice, packing list, or other document accompanying the plant, the following information: (1) Genus and species, and quantity of each (if a hybrid, genus of each parent, and quantity of each hybrid), (2) Country and locality where collected from the wild or where produced from cultivated stock, (3) Name and address (in the United States if exported or reexported) of shipper, owner or person shipping or forwarding the plants, (4) Name and address (in the United States if imported) of consignee, (5) Identifying shipper's mark and number, and (6) Serial number and type (e.g., permit, certificate) of document issued for the importation, exportation, or reexportation of the plant. (b) Promptly upon arrival at a port of import (listed in 50 CFR part 24, or, if allowed by the U.S. Department of the Interior, at a nondesignated port) of any terrestrial plant which is imported by means other than mail and which may be imported under 50 CFR part 17 or part 23 only if… | ||||
| 7:7:5.1.1.1.15.3.47.2 | 7 | Agriculture | III | 355 | PART 355—ENDANGERED SPECIES REGULATIONS CONCERNING TERRESTRIAL PLANTS | C | Subpart C—Inspections and Related Provisions | § 355.21 Marking and mailing requirements for plants imported, exported, or reexported by mail. | APHIS | (a) Any terrestrial plant which is to be imported by mail and which may be imported under 50 CFR part 17 or part 23 only if accompanied by documentation, shall be mailed to Plant Protection and Quarantine (at a port authorized for such purpose by the U.S. Department of the Interior in 50 CFR part 24 pursuant to section 9(f) of the Act (16 U.S.C. 1538 (f))); and shall be accompanied by a separate sheet of paper within the package plainly and correctly bearing the name, address, and telephone number of the intended recipient in the United States; and shall plainly and correctly bear on the outer container the following information: (1) Genus and species, and quantity of each (if a hybrid, genus of each parent, and quantity of each hybrid), (2) Country and locality where collected from the wild or where produced from cultivated stock, (3) Name and address of shipper, owner, or person shipping or forwarding the plants, and (4) Serial number and type (e.g. permit, certificate) of document issued for the importation of the plant. (b) Any terrestrial plant which is to be exported or reexported by mail and which may be exported or reexported under 50 CFR part 17 or part 23 only if accompanied by documentation, shall be mailed to Plant Protection and Quarantine (at a port authorized for such purpose by the U.S. Department of the Interior in 50 CFR part 24 pursuant to section 9(f) of the Act (16 U.S.C. 1538(f))); shall be wrapped in double wrapping, with an unsealed inner wrapping addressed to the foreign recipient and bearing sufficient postage for mailing to the foreign destination; shall be accompanied by a separate sheet of paper within the package plainly and correctly bearing the following information: (1) Genus and species, and quantity of each (if a hybrid, genus of each parent, and quantity of each hybrid), (2) Country and locality where collected from the wild or where produced from cultivated stock, (3) Name and address in the United States of shipper, owner, or person shipping or forwarding the plants, … | |||||
| 7:7:5.1.1.1.15.3.47.3 | 7 | Agriculture | III | 355 | PART 355—ENDANGERED SPECIES REGULATIONS CONCERNING TERRESTRIAL PLANTS | C | Subpart C—Inspections and Related Provisions | § 355.22 Validation of documentation. | APHIS | [49 FR 42912, Oct. 25, 1984, as amended at 59 FR 67611, Dec. 30, 1994; 70 FR 57995, Oct. 5, 2005] | (a) Documentation for any mailed or nonmailed terrestrial plant which is required to have documentation under 50 CFR part 17 or part 23 at the time of importation, must be validated by an inspector prior to movement of such plant from the Customs inspection area at the port of entry. The original documentation must be surrendered to the inspector at the time of validation. (b) Documentation for any mailed or nonmailed terrestrial plant which is listed in 50 CFR 17.12 or 23.23 and which is required to have documentation under 50 CFR part 17 or part 23 at the time of exportation or reexportation, must be validated at the port of export or reexport by an inspector prior to the exportation or reexportation of such plant. 5 The original and one copy of the documentation must be submitted for validation, and the copy must be surrendered to the inspector at the time of validation. 5 It is the policy of the Department of Agriculture to allow, if inspectors are available, terrestrial plants listed in 50 CFR 17.12 or 23.23 which are intended for export to be inspected at the premises where such plants are grown. However, the documentation required for the export of such plants by 50 CFR part 17 or part 23 shall only be validated at the port of export and only when such plants are presented at the port for export together with the documents required by 50 CFR part 17 or part 23 and a certified statement by the inspector who inspected the plants that the plants are apparently eligible for exportation in accordance with the provisions of this part and provisions of 50 CFR chapter I relating to the Act and Convention. Plants which have been previously inspected must be exported through a designated port (unless allowed by the United States Department of the Interior to be exported through a nondesignated port) in order to comply with section 9(f) of the Act [16 U.S.C. 1538(f)]. Plants which are inspected at the premises of origin must be available at the port of export for monitoring inspections and for other inspecti… | ||||
| 7:7:5.1.1.1.15.3.47.4 | 7 | Agriculture | III | 355 | PART 355—ENDANGERED SPECIES REGULATIONS CONCERNING TERRESTRIAL PLANTS | C | Subpart C—Inspections and Related Provisions | § 355.23 Recordkeeping, access, and reports. | APHIS | (a) Any person engaged in business as an importer, exporter, or reexporter of terrestrial plants listed in 50 CFR part 17 or part 23 shall keep such records as will fully and correctly disclose each importation, exportation, or reexportation of terrestrial plants made by such person and the subsequent disposition made by such person of the plants. Such records shall include shipping documents for each shipment of plants imported, exported, or reexported; a description of the form of the plants (such as whole live plants, cuttings, seeds, or other specific parts or derivatives of plants); the scientific and common names of the plants; the country or place of origin of the plants; the date and place of importation, exportation, or reexportation of the plants; the number (weight if the plants cannot be quantified by number) and specific location of plants; the date and means of subsequent disposition of the plants, whether by sale, barter, consignment, loan, delivery, destruction, or other means; and names and addresses of persons to whom the plants were disposed, if applicable. (b) Every record required to be kept under this section shall be kept for a period of 5 years after the occurrence of the transactions to which the records relate, and for such further time as the Deputy Administrator may require by written notice to the person required to keep such records under this part for purposes of any investigation, litigation, or other proceeding under the Act or this part. (c) Any person engaged in business as an importer, exporter, or reexporter of terrestrial plants listed in 50 CFR part 17 or part 23 shall, upon presentation of credentials by an inspector or duly authorized representatives of the Secretary; during ordinary business hours of the person given notice, afford such inspector access to the person's place of business, the opportunity to examine the person's inventory of plants and the records required to be kept under paragraph (a) of this section, and the opportunity to copy such records. The use of… |
Advanced export
JSON shape: default, array, newline-delimited, object
CREATE TABLE cfr_sections (
section_id TEXT PRIMARY KEY,
title_number INTEGER,
title_name TEXT,
chapter TEXT,
subchapter TEXT,
part_number TEXT,
part_name TEXT,
subpart TEXT,
subpart_name TEXT,
section_number TEXT,
section_heading TEXT,
agency TEXT,
authority TEXT,
source_citation TEXT,
amendment_citations TEXT,
full_text TEXT
);
CREATE INDEX idx_cfr_title ON cfr_sections(title_number);
CREATE INDEX idx_cfr_part ON cfr_sections(part_number);
CREATE INDEX idx_cfr_agency ON cfr_sections(agency);