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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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| 21:21:5.0.1.1.27.1.1.1 | 21 | Food and Drugs | I | D | 352 | PART 352—SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY] | A | Subpart A—General Provisions | § 352.1 Scope. | FDA | (a) An over-the-counter sunscreen drug product in a form suitable for topical administration 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. | ||||
| 21:21:5.0.1.1.27.1.1.2 | 21 | Food and Drugs | I | D | 352 | PART 352—SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY] | A | Subpart A—General Provisions | § 352.3 Definitions. | FDA | As used in this part: (a) Minimal erythema dose (MED). The quantity of erythema-effective energy (expressed as Joules per square meter) required to produce the first perceptible, redness reaction with clearly defined borders. (b) Product category designation (PCD). A labeling designation for sunscreen drug products to aid in selecting the type of product best suited to an individual's complexion (pigmentation) and desired response to ultraviolet (UV) radiation. (1) Minimal sun protection product. A sunscreen product that provides a sun protection factor (SPF) value of 2 to under 12. (2) Moderate sun protection product. A sunscreen product that provides an SPF value of 12 to under 30. (3) High sun protection product. A sunscreen product that provides an SPF value of 30 or above. (c) Sunscreen active ingredient. An active ingredient listed in § 352.10 that absorbs, reflects, or scatters radiation in the UV range at wavelengths from 290 to 400 nanometers. (d) Sun protection factor (SPF) value. The UV energy required to produce an MED on protected skin divided by the UV energy required to produce an MED on unprotected skin, which may also be defined by the following ratio: SPF value = MED (protected skin (PS))/MED (unprotected skin (US)), where MED (PS) is the minimal erythema dose for protected skin after application of 2 milligrams per square centimeter of the final formulation of the sunscreen product, and MED (US) is the minimal erythema dose for unprotected skin, i.e. , skin to which no sunscreen product has been applied. In effect, the SPF value is the reciprocal of the effective transmission of the product viewed as a UV radiation filter. | ||||
| 21:21:5.0.1.1.27.2.1.1 | 21 | Food and Drugs | I | D | 352 | PART 352—SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY] | B | Subpart B—Active Ingredients | § 352.10 Sunscreen active ingredients. | FDA | [64 FR 27687, May 21, 1999] | The active ingredient of the product consists of any of the following, within the concentration specified for each ingredient, and the finished product provides a minimum SPF value of not less than 2 as measured by the testing procedures established in subpart D of this part: (a) Aminobenzoic acid (PABA) up to 15 percent. (b) Avobenzone up to 3 percent. (c) Cinoxate up to 3 percent. (d) [Reserved] (e) Dioxybenzone up to 3 percent. (f) Homosalate up to 15 percent. (g) [Reserved] (h) Menthyl anthranilate up to 5 percent. (i) Octocrylene up to 10 percent. (j) Octyl methoxycinnamate up to 7.5 percent. (k) Octyl salicylate up to 5 percent. (l) Oxybenzone up to 6 percent. (m) Padimate O up to 8 percent. (n) Phenylbenzimidazole sulfonic acid up to 4 percent. (o) Sulisobenzone up to 10 percent. (p) Titanium dioxide up to 25 percent. (q) Trolamine salicylate up to 12 percent. (r) Zinc oxide up to 25 percent. (f) Ensulizole up to 4 percent. (g) Homosalate up to 15 percent. (h) [Reserved] (i) Meradimate up to 5 percent. (j) Octinoxate up to 7.5 percent. (k) Octisalate up to 5 percent. (l) Octocrylene up to 10 percent. (m) Oxybenzone up to 6 percent. (n) Padimate O up to 8 percent. | |||
| 21:21:5.0.1.1.27.2.1.3 | 21 | Food and Drugs | I | D | 352 | PART 352—SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY] | B | Subpart B—Active Ingredients | § 352.20 Permitted combinations of active ingredients. | FDA | [64 FR 27687, May 21, 1999, as amended at 68 FR 33380, June 4, 2003] | The SPF of any combination product is measured by the testing procedures established in subpart D of this part. (a) Combinations of sunscreen active ingredients. (1) Two or more sunscreen active ingredients identified in § 352.10(a), (c), (e), (f), and (h) through (r) may be combined with each other in a single product when used in the concentrations established for each ingredient in § 352.10. The concentration of each active ingredient must be sufficient to contribute a minimum SPF of not less than 2 to the finished product. The finished product must have a minimum SPF of not less than the number of sunscreen active ingredients used in the combination multiplied by 2. (2) Two or more sunscreen active ingredients identified in § 352.10(b), (c), (e), (f), (i) through (l), (o), and (q) may be combined with each other in a single product when used in the concentrations established for each ingredient in § 352.10. The concentration of each active ingredient must be sufficient to contribute a minimum SPF of not less than 2 to the finished product. The finished product must have a minimum SPF of not less than the number of sunscreen active ingredients used in the combination multiplied by 2. (b) Combinations of sunscreen and skin protectant active ingredients. Any single sunscreen active ingredient or any permitted combination of sunscreen active ingredients when used in the concentrations established for each ingredient in § 352.10 may be combined with one or more skin protectant active ingredients identified in § 347.10(a), (d), (e), (g), (h), (i), (k), (l), (m), and (r) of this chapter. The concentration of each sunscreen active ingredient must be sufficient to contribute a minimum SPF of not less that 2 to the finished product. The finished product must have a minimum SPF of not less than the number of sunscreen active ingredients used in the combination multiplied by 2, and the product must be labeled according to § 352.60. (c) [Reserved] (a) Combinations of sunscreen active ingredients. (1) Two or mor… | |||
| 21:21:5.0.1.1.27.3.1.1 | 21 | Food and Drugs | I | D | 352 | PART 352—SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY] | C | Subpart C—Labeling | § 352.50 Principal display panel of all sunscreen drug products. | FDA | In addition to the statement of identity required in § 352.52, the following labeling statements shall be prominently placed on the principal display panel: (a) For products that do not satisfy the water resistant or very water resistant sunscreen product testing procedures in § 352.76 —(1) For products with SPF values up to 30. “SPF (insert tested SPF value of the product up to 30).” (2) For products with SPF values over 30. “SPF 30” (select one of the following: “plus” or “ + ”). Any statement accompanying the marketed product that states a specific SPF value above 30 or similar language indicating a person can stay in the sun more than 30 times longer than without sunscreen will cause the product to be misbranded under section 502 of the Federal Food, Drug, and Cosmetic Act (the act). (b) For products that satisfy the water resistant sunscreen product testing procedures in § 352.76. (1) (Select one of the following: “Water,” “Water/Sweat,” or “Water/Perspiration”) “Resistant.” (2) “SPF (insert SPF value of the product, as stated in paragraph (a)(1) or (a)(2) of this section, after it has been tested using the water resistant sunscreen product testing procedures in § 352.76).” (c) For products that satisfy the very water resistant sunscreen product testing procedures in § 352.76. (1) “Very” (select one of the following: “Water,” “Water/Sweat,” or “Water/Perspiration”) “Resistant.” (2) “SPF (insert SPF value of the product, as stated in paragraph (a)(1) or (a)(2) of this section, after it has been tested using the very water resistant sunscreen product testing procedures in § 352.76).” | ||||
| 21:21:5.0.1.1.27.3.1.2 | 21 | Food and Drugs | I | D | 352 | PART 352—SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY] | C | Subpart C—Labeling | § 352.52 Labeling of sunscreen drug products. | FDA | [64 FR 27687, May 21, 1999, as amended at 68 FR 33380, June 4, 2003] | (a) Statement of identity. The labeling of the product contains the established name of the drug, if any, and identifies the product as a “sunscreen.” (b) Indications. The labeling of the product states, under the heading “Uses,” all of the phrases listed in paragraph (b)(1) of this section that are applicable to the product and may contain any of the additional phrases listed in paragraph (b)(2) of this section, as appropriate. Other truthful and nonmisleading statements, describing only the uses that have 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 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. (1) For products containing any ingredient in § 352.10. (i) “[bullet] 1 helps prevent sunburn [bullet] higher SPF gives more sunburn protection”. 1 See § 201.66(b)(4) of this chapter. (ii) For products that satisfy the water resistant testing procedures identified in § 352.76. “[bullet] retains SPF after 40 minutes of” (select one or more of the following: “activity in the water,” “sweating,” or “perspiring”). (iii) For products that satisfy the very water resistant testing procedures identified in § 352.76. “[bullet] retains SPF after 80 minutes of” (select one or more of the following: “activity in the water,” “sweating,” or “perspiring”). (2) Additional indications. In addition to the indications provided in paragraph (b)(1) of this section, the following may be used for products containing any ingredient in § 352.10: (i) For products that provide an SPF of 2 to under 12. Select one or both of the following: [“[bullet]” (select one of the following: “provides minimal,” “provides minimum,” “minimal,” or “minimum”) “protection against” (select one of the following: “sunburn” or “sunburn and tanning”)], … | |||
| 21:21:5.0.1.1.27.3.1.3 | 21 | Food and Drugs | I | D | 352 | PART 352—SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY] | C | Subpart C—Labeling | § 352.60 Labeling of permitted combinations of active ingredients. | FDA | [64 FR 27687, May 21, 1999, as amended at 68 FR 33380, June 4, 2003] | Statements of identity, indications, warnings, and directions for use, respectively, applicable to each ingredient in the product may be combined to eliminate duplicative words or phrases so that the resulting information is clear and understandable. (a) Statement of identity. For a combination drug product that has an established name, the labeling of the product states the established name of the combination drug product, followed by the statement of identity for each ingredient in the combination, as established in the statement of identity sections of the applicable OTC drug monographs. For a combination drug product that does not have an established name, the labeling of the product states the statement of identity for each ingredient in the combination, as established in the statement of identity sections of the applicable OTC drug monographs. (b) Indications. The labeling of the product states, under the heading “Uses,” the indication(s) for each ingredient in the combination as established in the indications sections of the applicable OTC drug monographs, unless otherwise stated in this paragraph. Other truthful and nonmisleading statements, describing only the indications for use that have been established in the applicable OTC drug monographs or listed in this paragraph (b), may also be used, as provided by § 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. (1) In addition, the labeling of the product may contain any of the “other allowable statements” that are identified in the applicable monographs. (2) For permitted combinations containing a sunscreen and a skin protectant identified in § 352.20(b), any or all of the applicable indications for sunscreens in § 352.52(b) and the indication for skin protect… | |||
| 21:21:5.0.1.1.27.4.1.1 | 21 | Food and Drugs | I | D | 352 | PART 352—SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY] | D | Subpart D—Testing Procedures | § 352.70 Standard sunscreen. | FDA | (a) Laboratory validation. A standard sunscreen shall be used concomitantly in the testing procedures for determining the SPF value of a sunscreen drug product to ensure the uniform evaluation of sunscreen drug products. The standard sunscreen shall be an 8-percent homosalate preparation with a mean SPF value of 4.47 (standard deviation = 1.279). In order for the SPF determination of a test product to be considered valid, the SPF of the standard sunscreen must fall within the standard deviation range of the expected SPF ( i.e. , 4.47 ±1.279) and the 95-percent confidence interval for the mean SPF must contain the value 4. (b) Preparation of the standard homosalate sunscreen. (1) The standard homosalate sunscreen is prepared from two different preparations (preparation A and preparation B) with the following compositions: Composition of Preparation A and Preparation B of the Standard Sunscreen (2) Preparation A and preparation B are heated separately to 77 to 82 °C, with constant stirring, until the contents of each part are solubilized. Add preparation A slowly to preparation B while stirring. Continue stirring until the emulsion formed is cooled to room temperature (15 to 30 °C). Add sufficient purified water to obtain 100 grams of standard sunscreen preparation. (c) Assay of the standard homosalate sunscreen. Assay the standard homosalate sunscreen preparation by the following method to ensure proper concentration: (1) Preparation of the assay solvent. The solvent consists of 1 percent glacial acetic acid (V/V) in denatured ethanol. The denatured ethanol should not contain a UV radiation absorbing denaturant. (2) Preparation of a 1-percent solution of the standard homosalate sunscreen preparation. Accurately weigh 1 gram of the standard homosalate sunscreen preparation into a 100-milliliter volumetric flask. Add 50 milliliters of the assay solvent. Heat on a steam bath and mix well. Cool the solution to room temperature (15 to 30 °C). Then dilute the solution to volume with the assay solvent an… | ||||
| 21:21:5.0.1.1.27.4.1.2 | 21 | Food and Drugs | I | D | 352 | PART 352—SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY] | D | Subpart D—Testing Procedures | § 352.71 Light source (solar simulator). | FDA | A solar simulator used for determining the SPF of a sunscreen drug product should be filtered so that it provides a continuous emission spectrum from 290 to 400 nanometers similar to sunlight at sea level from the sun at a zenith angle of 10° it has less than 1 percent of its total energy output contributed by nonsolar wavelengths shorter than 290 nanometers; and it has not more than 5 percent of its total energy output contributed by wavelengths longer than 400 nanometers. In addition, a solar simulator should have no significant time-related fluctuations in radiation emissions after an appropriate warmup time, and it should have good beam uniformity (within 10 percent) in the exposure plane. To ensure that the solar simulator delivers the appropriate spectrum of UV radiation, it must be measured periodically with an accurately-calibrated spectroradiometer system or equivalent instrument. | ||||
| 21:21:5.0.1.1.27.4.1.3 | 21 | Food and Drugs | I | D | 352 | PART 352—SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY] | D | Subpart D—Testing Procedures | § 352.72 General testing procedures. | FDA | (a) Selection of test subjects (male and female). (1) Only fair-skin subjects with skin types I, II, and III using the following guidelines shall be selected: Selection of Fair-skin Subjects Skin Type and Sunburn and Tanning History (Based on first 30 to 45 minutes sun exposure after a winter season of no sun exposure.) I—Always burns easily; never tans (sensitive). II—Always burns easily; tans minimally (sensitive). III—Burns moderately; tans gradually (light brown) (normal). IV—Burns minimally; always tans well (moderate brown) (normal). V—Rarely burns; tans profusely (dark brown) (insensitive). VI—Never burns; deeply pigmented (insensitive). Selection of Fair-skin Subjects Skin Type and Sunburn and Tanning History (Based on first 30 to 45 minutes sun exposure after a winter season of no sun exposure.) I—Always burns easily; never tans (sensitive). II—Always burns easily; tans minimally (sensitive). III—Burns moderately; tans gradually (light brown) (normal). IV—Burns minimally; always tans well (moderate brown) (normal). V—Rarely burns; tans profusely (dark brown) (insensitive). VI—Never burns; deeply pigmented (insensitive). (2) A medical history shall be obtained from all subjects with emphasis on the effects of sunlight on their skin. Ascertain the general health of the individual, the individual's skin type (I, II, or III), whether the individual is taking medication (topical or systemic) that is known to produce abnormal sunlight responses, and whether the individual is subject to any abnormal responses to sunlight, such as a phototoxic or photoallergic response. (b) Test site inspection. The physical examination shall determine the presence of sunburn, suntan, scars, active dermal lesions, and uneven skin tones on the areas of the back to be tested. The presence of nevi, blemishes, or moles will be acceptable if in the physician's judgment they will not interfere with the study results. Excess hair on the back is acceptable if the hair is clipped or shaved. (c) Inf… | ||||
| 21:21:5.0.1.1.27.4.1.4 | 21 | Food and Drugs | I | D | 352 | PART 352—SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY] | D | Subpart D—Testing Procedures | § 352.73 Determination of SPF value. | FDA | (a)(1) The following erythema action spectrum shall be used to calculate the erythema effective exposure of a solar simulator: V i (λ) = 1.0 (250 <λ <298 nm) V i (λ) = 1.0 0.094 (298 - l ) (298 <λ <328 nanometers) V i (λ) = 1.0 0.015 (139 - l ) (328 <λ <400 nanometers) (2) The data contained in this action spectrum are to be used as spectral weighting factors to calculate the erythema effective exposure of a solar simulator as follows: (b) Determination of MED of the unprotected skin. A series of UV radiation exposures expressed as Joules per square meter (adjusted to the erythema action spectrum calculated according to § 352.73(a)) is administered to the subsite areas on each subject with an accurately calibrated solar simulator. A series of five exposures shall be administered to the untreated, unprotected skin to determine the subject's inherent MED. The doses selected shall be a geometric series represented by (1.25 n ), wherein each exposure time interval is 25 percent greater than the previous time to maintain the same relative uncertainty (expressed as a constant percentage), independent of the subject's sensitivity to UV radiation, regardless of whether the subject has a high or low MED. Usually, the MED of a person's unprotected skin is determined the day prior to testing a product. This MED(US) shall be used in the determination of the series of UV radiation exposures to be administered to the protected site in subsequent testing. The MED(US) should be determined again on the same day as the standard and test sunscreens and this MED(US) should be used in calculating the SPF. (c) Determination of individual SPF values. A series of UV radiation exposures expressed as Joules per square meter (adjusted to the erythema action spectrum calculated according to § 352.73(a)) is administered to the subsite areas on each subject with an accurately-calibrated solar simulator. A series of seven exposures shall be administered to the protected test sites to determine the MED of the protected skin … | ||||
| 21:21:5.0.1.1.27.4.1.5 | 21 | Food and Drugs | I | D | 352 | PART 352—SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY] | D | Subpart D—Testing Procedures | § 352.76 Determination if a product is water resistant or very water resistant. | FDA | The general testing procedures in § 352.72 shall be used as part of the following tests, except where modified in this section. An indoor fresh water pool, whirlpool, and/or jacuzzi maintained at 23 to 32 °C shall be used in these testing procedures. Fresh water is clean drinking water that meets the standards in 40 CFR part 141. The pool and air temperature and the relative humidity shall be recorded. (a) Procedure for testing the water resistance of a sunscreen product. For sunscreen products making the claim of “water resistant,” the label SPF shall be the label SPF value determined after 40 minutes of water immersion using the following procedure for the water resistance test: (1) Apply sunscreen product (followed by the waiting period after application of the sunscreen product indicated on the product labeling). (2) 20 minutes moderate activity in water. (3) 20-minute rest period (do not towel test sites). (4) 20 minutes moderate activity in water. (5) Conclude water test (air dry test sites without toweling). (6) Begin solar simulator exposure to test site areas as described in § 352.73. (b) Procedure for testing a very water resistant sunscreen product. For sunscreen products making the claim of “very water resistant,” the label SPF shall be the label SPF value determined after 80 minutes of water immersion using the following procedure for the very water resistant test: (1) Apply sunscreen product (followed by the waiting period after application of the sunscreen product indicated on the product labeling). (2) 20 minutes moderate activity in water. (3) 20-minute rest period (do not towel test sites). (4) 20 minutes moderate activity in water. (5) 20-minute rest period (do not towel test sites). (6) 20 minutes moderate activity in water. (7) 20-minute rest period (do not towel test sites). (8) 20 minutes moderate activity in water. (9) Conclude water test (air dry test sites without toweling). (10) Begin solar simulator exposure to test site areas as described in § 352.73. | ||||
| 21:21:5.0.1.1.27.4.1.6 | 21 | Food and Drugs | I | D | 352 | PART 352—SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY] | D | Subpart D—Testing Procedures | § 352.77 Test modifications. | FDA | The formulation or mode of administration of certain products may require modification of the testing procedures in this subpart. In addition, alternative methods (including automated or in vitro procedures) employing the same basic procedures as those described in this subpart may be used. Any proposed modification or alternative procedure 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 procedure provides results of equivalent accuracy. All information submitted will be subject to the disclosure rules in part 20 of this chapter. | ||||
| 44:44:1.0.1.6.86.0.10.1 | 44 | Emergency Management and Assistance | I | F | 352 | PART 352—COMMERCIAL NUCLEAR POWER PLANTS: EMERGENCY PREPAREDNESS PLANNING | § 352.1 Definitions. | FEMA | As used in this part, the following terms and concepts are defined: (a) Deputy Administrator means the Deputy Administrator, National Preparedness Directorate, FEMA or designee. (b) Administrator means the Administrator, FEMA or designee. (c) EPZ means Emergency Planning Zone. (d) FEMA means the Federal Emergency Management Agency. (e) NRC means the Nuclear Regulatory Commission. (f) Regional Administrator means the Regional Administrator of FEMA or designee. (g) Local government means boroughs, cities, counties, municipalities, parishes, towns, townships or other local jurisdictions within the plume and ingestion exposure pathway EPZs that have specific roles in emergency planning and preparedness. (h) Decline or fail means a situation where State or local governments do not participate in preparing offsite emergency plans or have significant planning or preparedness inadequacies and have not demonstrated the commitment or capabilities to correct those inadequacies in a timely manner so as to satisfy NRC licensing requirements. (i) Governor means the Governor of a State or his/her designee. (j) Certification means the written justification by a licensee of the need for Federal compensatory assistance. This certification is required to activate the Federal assistance under this part. (k) Responsible local official means the highest elected official of an appropriate local government. (l) Technical assistance means services provided by FEMA and other Federal agencies to facilitate offsite radiological emergency planning and preparedness such as: Provision of support for the preparation off site radiological emergency response plans and procedures; FEMA coordination of services from other Federal agencies; provision and interpretation of Federal guidance; provision of Federal and contract personnel to offer advice and recommendations for specific aspects of preparedness such as alert and notification and emergency public information. (m) Federal facilities and resources means … | ||||||
| 44:44:1.0.1.6.86.0.10.2 | 44 | Emergency Management and Assistance | I | F | 352 | PART 352—COMMERCIAL NUCLEAR POWER PLANTS: EMERGENCY PREPAREDNESS PLANNING | § 352.2 Scope, purpose and applicability. | FEMA | (a) This part applies whenever State or local governments, either individually or together, decline or fail to prepare commercial nuclear power plant offsite radiological emergency preparedness plans that are sufficient to satisfy NRC licensing requirements or to participate adequately in the preparation, demonstration, testing, exercise, or use of such plans. In order to request the assistance provided for in this part, an affected nuclear power plant applicant or licensee shall certify in writing to FEMA that the above situation exists. (b) The purposes of this part are as follows: (1) To establish policies and procedures for the submission of a licensee certification for Federal assistance under Executive Order 12657; (2) set forth policies and procedures for FEMA's determination to accept, accept with modification, or reject the licensee certification; (3) establish a framework for providing Federal assistance to licensees; and (4) provide procedures for the review and evaluation of the adequacy of offsite radiological emergency planning and preparedness. Findings and determinations on offsite planning and preparedness made under this part are provided to the NRC for its use in the licensing process. (c) This part applies only in instances where Executive Order 12657 is used by a licensee and its provisions do not affect the validity of the emergency preparedness developed by the licensee independent of or prior to Executive Order 12657. | ||||||
| 44:44:1.0.1.6.86.1.10.1 | 44 | Emergency Management and Assistance | I | F | 352 | PART 352—COMMERCIAL NUCLEAR POWER PLANTS: EMERGENCY PREPAREDNESS PLANNING | A | Subpart A—Certifications and Determinations | § 352.3 Purpose and scope. | FEMA | This subpart establishes policies and procedures for submission by a commercial nuclear power plant licensee of a certification for Federal assistance under Executive Order 12657. It contains policies and procedures for FEMA's determinations, with respect to a certification. It establishes a framework for providing Federal assistance to licensees. It also provides procedures for review and evaluation of the adequacy of licensee offsite radiological emergency planning and preparedness. | ||||
| 44:44:1.0.1.6.86.1.10.2 | 44 | Emergency Management and Assistance | I | F | 352 | PART 352—COMMERCIAL NUCLEAR POWER PLANTS: EMERGENCY PREPAREDNESS PLANNING | A | Subpart A—Certifications and Determinations | § 352.4 Licensee certification. | FEMA | [54 FR 31925, Aug. 2, 1989, as amended at 74 FR 15357, Apr. 3, 2008] | (a) A licensee which seeks Federal assistance under this part shall submit a certification to the host FEMA Regional Administrator that a decline or fail situation exists. The certification shall be in the form of a letter from the chief executive officer of the licensee. The contents of this letter shall address the provisions set forth in paragraphs (b) and (c) of this section. (b) The licensee certification shall delineate why such assistance is needed based on the criteria of decline or fail for the relevant State or local governments. (c) The licensee certification shall document requests to and responses from the Governor(s) or responsible local official(s) with respect to the efforts taken by the licensee to secure their participation, cooperation, commitment of resources or timely correction of planning and preparedness failures. | |||
| 44:44:1.0.1.6.86.1.10.3 | 44 | Emergency Management and Assistance | I | F | 352 | PART 352—COMMERCIAL NUCLEAR POWER PLANTS: EMERGENCY PREPAREDNESS PLANNING | A | Subpart A—Certifications and Determinations | § 352.5 FEMA action on licensee certification. | FEMA | (a) Upon receiving a licensee certification, the host Regional Administrator shall immediately notify FEMA Headquarters of the licensee certification. Within 5 days the host Regional Administrator shall notify the Governor of an affected State and the chief executive officer of any local government that a certification has been received, and make a copy of the certification available to such persons. Within 10 days, the host Regional Administrator shall acknowledge in writing the receipt of the certification to the licensee. (b) Within 15 days of receipt of the certification, the Regional Administrator shall publish a notice in the Federal Register that a certification from the licensee has been received, and that copies are available at the Regional Office for review and copying in accordance with 44 CFR 5.26. (c) FEMA Headquarters shall notify the NRC of receipt of the certification and shall request advice from the NRC on whether a decline or fail situation exists. (d) State and local governments may submit written statements to the host Regional Administrator outlining their position as to the facts stated in the letter of certification. Such statements shall be submitted to FEMA within 10 days of the date of notification provided to State and local government under § 352.5(a). Any such statements shall be a part of the record and will be considered in arriving at recommendations or determinations made under the provisions of this part. (e) The host FEMA Regional Office shall provide, after consulting with State and responsible local officials, a recommended determination on whether a decline or fail situation exists to the FEMA Deputy Administrator for the National Preparedness Directorate within 30 days of receipt of the licensee certification. (f) The FEMA Deputy Administrator for the National Preparedness Directorate shall make a determination on whether a decline or fail situation exists within 45 days of receipt of the licensee certification and shall advise the licensee, NRC, and State and local… | ||||
| 44:44:1.0.1.6.86.1.10.4 | 44 | Emergency Management and Assistance | I | F | 352 | PART 352—COMMERCIAL NUCLEAR POWER PLANTS: EMERGENCY PREPAREDNESS PLANNING | A | Subpart A—Certifications and Determinations | § 352.6 FEMA determination on the commitment of Federal facilities and resources. | FEMA | (a) A licensee request for Federal facilities and resources shall document the licensee's maximum feasible use of its resources and its efforts to secure the use of State and local government and volunteer resources. (b) Upon a licensee request for Federal facilities and resources, FEMA headquarters shall notify NRC and request advice from the NRC as to whether the licensee has made maximum use of its resources and the extent to which the licensee has complied with 10 CFR 50.47(c)(1). The host FEMA Regional Administratorshall make a recommendation to the FEMA Deputy Administrator for the National Preparedness Directorate on whether the provision of these facilities and resources is warranted. The FEMA Deputy Administrator for the National Preparedness Directorate shall make a final determination as to whether Federal facilities and resources are needed. (c) In making the determination under paragraph (b) of this section, FEMA: (1) Shall work actively with the licensee, and before relying upon any Federal resources, shall make maximum feasible use of the licensee's own resources, which may include agreements with volunteer organizations and other government entities and agencies; and (2) Shall assume that, in the event of an actual radiological emergency or disaster, State and local authorities would contribute their full resources and exercise their authorities in accordance with their duties to protect the public and would act generally in conformity with the licensee's radiological emergency preparedness plan. (d) The FEMA Deputy Administrator for the National Preparedness Directorate shall make a determination on the need for and commitment of Federal facilities and resources. The FEMA determination shall be made in consultation with affected Federal agencies and in accordance with 44 CFR 352.21. FEMA shall inform the licensee, the States and affected local governments in writing of the Federal support which will be provided. This information shall identify Federal agencies that are to provide Federal sup… | ||||
| 44:44:1.0.1.6.86.1.10.5 | 44 | Emergency Management and Assistance | I | F | 352 | PART 352—COMMERCIAL NUCLEAR POWER PLANTS: EMERGENCY PREPAREDNESS PLANNING | A | Subpart A—Certifications and Determinations | § 352.7 Review and evaluation. | FEMA | FEMA shall conduct its activities and make findings under this part in a manner consistent with 44 CFR part 350 to the extent that those procedures are appropriate and not inconsistent with the intent and procedures required by E.O. 12657. This Order shall take precedence, and any inconsistencies shall be resolved under the procedures in the NRC/FEMA Memorandum of Understanding (MOU) on planning and preparedness. (50 FR 15485, April 18, 1985) | ||||
| 44:44:1.0.1.6.86.2.10.1 | 44 | Emergency Management and Assistance | I | F | 352 | PART 352—COMMERCIAL NUCLEAR POWER PLANTS: EMERGENCY PREPAREDNESS PLANNING | B | Subpart B—Federal Participation | § 352.20 Purpose and scope. | FEMA | This subpart establishes policy and procedures for providing support for offsite radiological emergency planning and preparedness in a situation where Federal support under Executive Order 12657 (E.O. 12657) has been requested. This subpart: (a) Describes the process for providing Federal technical assistance to the licensee for developing its offsite emergency response plan after an affirmative determination on the licensee certification under subpart A (44 CFR 352.5(f)); (b) Describes the process for providing Federal facilities and resources to the licensee after a determination under subpart A (44 CFR 352.6(d)) that Federal resources are required; (c) Describes the principal response functions which Federal agencies may be called upon to provide; (d) Describes the process for allocating responsibilities among Federal agencies for planning site-specific emergency response functions; and (e) Provides for the participation of Federal agencies, including the members of the FRPCC and the RACs. | ||||
| 44:44:1.0.1.6.86.2.10.10 | 44 | Emergency Management and Assistance | I | F | 352 | PART 352—COMMERCIAL NUCLEAR POWER PLANTS: EMERGENCY PREPAREDNESS PLANNING | B | Subpart B—Federal Participation | § 352.29 Appeal process. | FEMA | (a) Any interested party may appeal a determination made by the Deputy Administrator for the National Preparedness Directorate, under §§ 352.5 and 352.6 of this part, by submitting to the Administrator, FEMA, a written notice of appeal, within 30 days after issuance. The appeal is to be addressed to the Administrator, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472. The appeal letter shall state the specific reasons for the appeal and include documentation to support appellant arguments. The appeal is limited to matters of record under §§ 352.5 and 352.6. (b) Within 30 days of receipt of this letter, the FEMA Administrator or designee will review the record and make a final determination on the matter. (c) Copies of this determination shall be furnished to the Appellant, the State(s), affected local governments, and the NRC. (d) For purposes of this section, the term interested party means only a licensee, a State or a local government, as defined in § 352.1(g). | ||||
| 44:44:1.0.1.6.86.2.10.2 | 44 | Emergency Management and Assistance | I | F | 352 | PART 352—COMMERCIAL NUCLEAR POWER PLANTS: EMERGENCY PREPAREDNESS PLANNING | B | Subpart B—Federal Participation | § 352.21 Participating Federal agencies. | FEMA | (a) FEMA may call upon any Federal agency to participate in planning for the use of Federal facilities and resources in the licensee offsite emergency response plan. (b) FEMA may call upon the following agencies, and others as needed, to provide Federal technical assistance and Federal facilities and resources: (1) Department of Commerce; (2) Department of Defense; (3) Department of Energy; (4) Department of Health and Human Services; (5) Department of Housing and Urban Development; (6) Department of the Interior; (7) Department of Transportation; (8) Environmental Protection Agency; (9) Federal Communications Commission; (10) General Services Administration; (11) National Communications System; (12) Nuclear Regulatory Commission; (13) United States Department of Agriculture; and (14) Department of Veterans Affairs. (c) FEMA is the Federal agency primarily responsible for coordinating Federal assistance. FEMA may enter into Memorandums of Understanding (MOU) and other instruments with Federal agencies to provide technical assistance and to arrange for the commitment and utilization of Federal facilities and resources as necessary. FEMA also may use a MOU to delegate to another Federal agency, with the consent of that agency, any of the functions and duties assigned to FEMA. Following review and approval by OMB, FEMA will publish such documents in the Federal Register. | ||||
| 44:44:1.0.1.6.86.2.10.3 | 44 | Emergency Management and Assistance | I | F | 352 | PART 352—COMMERCIAL NUCLEAR POWER PLANTS: EMERGENCY PREPAREDNESS PLANNING | B | Subpart B—Federal Participation | § 352.22 Functions of the Federal Radiological Preparedness Coordinating Committee (FRPCC). | FEMA | Under 44 CFR part 351, the role of the FRPCC is to assist FEMA in providing policy direction for the program of technical assistance to State and local governments in their radiological emergency planning and preparedness activities. Under this subpart, the role of the FRPCC is to provide advice to FEMA regarding Federal assistance and Federal facilities and resources for implementing subparts A and B of this part. This assistance activity is extended to licensees. The FRPCC will assist FEMA in revising the Federal Radiological Emergency Response Plan (FRERP). | ||||
| 44:44:1.0.1.6.86.2.10.4 | 44 | Emergency Management and Assistance | I | F | 352 | PART 352—COMMERCIAL NUCLEAR POWER PLANTS: EMERGENCY PREPAREDNESS PLANNING | B | Subpart B—Federal Participation | § 352.23 Functions of a Regional Assistance Committee (RAC). | FEMA | (a) Under 44 CFR part 351, the role of a RAC is to assist State and local government officials to develop their radiological emergency plans, to review the plans, and to observe exercises to evaluate the plans. Under subparts A and B of this part, these technical assistance activities are extended to the licensee. (b) Prior to a determination under subpart A (44 CFR 352.6(d)) that Federal facilities and resources are needed, the designated RAC for the specific site will assist the licensee, as necessary, in evaluating the need for Federal facilities and resources, in addition to providing technical assistance under § 352.23(a). (c) In accomplishing the foregoing, the RAC will use the standards and evaluation criteria in NUREG-0654/FEMA-REP-1, Rev. 1 and Supp. 1. 1 or approved alternative approaches, and RAC members shall render such technical assistance as appropriate to their agency mission and expertise. 1 Copy available from FEMA Distribution Center, P.O. Box 70274 Washington, DC 20024 (d) Following determination under subpart A (44 CFR 352.6(d)) that Federal facilities and resources are needed, the RAC will assist FEMA in identifying agencies and specifying the Federal facilities and resources which the agencies are to provide. | ||||
| 44:44:1.0.1.6.86.2.10.5 | 44 | Emergency Management and Assistance | I | F | 352 | PART 352—COMMERCIAL NUCLEAR POWER PLANTS: EMERGENCY PREPAREDNESS PLANNING | B | Subpart B—Federal Participation | § 352.24 Provision of technical assistance and Federal facilities and resources. | FEMA | [54 FR 31925, Aug. 2, 1989, as amended at 74 FR 15357, Apr. 3, 2009] | (a) Under a determination under subpart A (44 CFR 352.5(f) and 352.4(e)) that a decline or fail situation exists, FEMA and other Federal agencies will provide technical assistance to the licensee. Such assistance may be provided during the pendency of an appeal under § 352.29. (b) The applicable criteria for the use of Federal facilities and resources are set forth in subpart A (44 CFR 352.6(c)(1)(2)). Upon a determination under subpart A (44 CFR 352.6(d)) that Federal resources or facilities will be required, FEMA will consult with the FRPCC, the RAC, the individual Federal agencies, and the licensee, to determine the extent of Federal facilities and resources that the government could provide, and the most effective way to do so. After such consultation, FEMA will specifically request Federal agencies to provide those Federal facilities and resources. The Federal agencies, in turn, will respond to confirm the availability of such facilities and resources and provide estimates of their costs. (c) FEMA will inform the licensee in writing of the Federal support which will be provided. This information will identify Federal agencies which are to be included in the plan, the extent and purpose of technical assistance to be provided and the Federal facilities and resources to be committed, and the limitations of their use. The information will also describe the requirements for reimbursement to the Federal Government for this support. (d) FEMA will coordinate the Federal effort in implementing the determinations made under subpart A (44 CFR 352.5(f) and 352.6(d)) so that each Federal agency maintains the committed technical assistance, facilities, and resources after the licensee offsite emergency response plan is completed. FEMA and other Federal agencies will participate in training, exercises, and drills, in support of the licensee offsite emergency response plan. (e) In carrying out paragraphs (a) through (c) of this section, FEMA will keep affected State and local governments informed of actions taken. | |||
| 44:44:1.0.1.6.86.2.10.6 | 44 | Emergency Management and Assistance | I | F | 352 | PART 352—COMMERCIAL NUCLEAR POWER PLANTS: EMERGENCY PREPAREDNESS PLANNING | B | Subpart B—Federal Participation | § 352.25 Limitation on committing Federal facilities and resources for emergency preparedness. | FEMA | (a) The commitment of Federal facilities and resources will be made through the authority of the affected Federal agencies. (b) In implementing a determination under subpart A (44 CFR 352.6(d)), that Federal facilities and resources are necessary for emergency preparedness, FEMA shall take care not to supplant State and local resources. Federal facilities and resources shall be substituted for those of the State and local governments in the licensee offsite emergency response plan only to the extent necessary to compensate for the nonparticipation or inadequate participation of those governments, and only as a last resort after consultation with the Governor(s) and responsible local officials in the affected area(s) regarding State and local participation. (c) All Federal planning activities described in this subpart will be conducted under the assumption that, in the event of an actual radiological emergency or disaster, State and local authorities would contribute their full resources and exercise their authorities in accordance with their duties to protect the public from harm and would act, generally, in conformity with the licensee's offsite emergency response plan. | ||||
| 44:44:1.0.1.6.86.2.10.7 | 44 | Emergency Management and Assistance | I | F | 352 | PART 352—COMMERCIAL NUCLEAR POWER PLANTS: EMERGENCY PREPAREDNESS PLANNING | B | Subpart B—Federal Participation | § 352.26 Arrangements for Federal response in the licensee offsite emergency response plan. | FEMA | Federal agencies may be called upon to assist the licensee in developing a licensee offsite emergency response plan in areas such as: (a) Arrangements for use of Federal facilities and resources for response functions such as: (1) Prompt notification of the emergency to the public; (2) Assisting in any necessary evacuation; (3) Providing reception centers or shelters and related facilities and services for evacuees; (4) Providing emergency medical services at Federal hospitals; and (5) Ensuring the creation and maintenance of channels of communication from commercial nuclear power plant licensees to State and local governments and to surrounding members of the public. (b) Arrangements for transferring response functions to State and local governments during the response in an actual emergency; and (c) Arrangements which may be necessary for FEMA coordination of the response of other Federal agencies. | ||||
| 44:44:1.0.1.6.86.2.10.8 | 44 | Emergency Management and Assistance | I | F | 352 | PART 352—COMMERCIAL NUCLEAR POWER PLANTS: EMERGENCY PREPAREDNESS PLANNING | B | Subpart B—Federal Participation | § 352.27 Federal role in the emergency response. | FEMA | In addition to the Federal component of the licensee offsite emergency response plan described in subpart B (§ 352.26), and after complying with E.O. 12657, Section 2(b)(2), which states that FEMA: (2) Shall take care not to supplant State and local resources and that FEMA shall substitute its own resources for those of State and local governments only to the extent necessary to compensate for the nonparticipation or inadequate participation of those governments, and only as a last resort after appropriate consultation with the Governors and responsible local officials in the affected area regarding State and local participation; (2) Shall take care not to supplant State and local resources and that FEMA shall substitute its own resources for those of State and local governments only to the extent necessary to compensate for the nonparticipation or inadequate participation of those governments, and only as a last resort after appropriate consultation with the Governors and responsible local officials in the affected area regarding State and local participation; FEMA shall provide for initial Federal response activities, including command and control of the offsite response, as may be needed. Any Federal response role, undertaken pursuant to this section, shall be transferred to State and local governments as soon as feasible after the onset of an actual emergency. | ||||
| 44:44:1.0.1.6.86.2.10.9 | 44 | Emergency Management and Assistance | I | F | 352 | PART 352—COMMERCIAL NUCLEAR POWER PLANTS: EMERGENCY PREPAREDNESS PLANNING | B | Subpart B—Federal Participation | § 352.28 Reimbursement. | FEMA | In accordance with Executive Order 12657, Section 6(d), and to the extent permitted by law, FEMA will coordinate full reimbursement, either jointly or severally, to the agencies performing services or furnishing resources, from any affected licensee and from any affected nonparticipating or inadequately participating State or local government. | ||||
| 7:7:5.1.1.1.12.0.47.1 | 7 | Agriculture | III | 352 | PART 352—PLANT QUARANTINE SAFEGUARD REGULATIONS | § 352.1 Definitions. | APHIS | [25 FR 1929, Mar. 5, 1960, as amended at 36 FR 24917, Dec. 24, 1971; 37 FR 10554, May 25, 1972; 62 FR 65009, Dec. 10, 1997; 66 FR 21059, Apr. 27, 2001; 71 FR 49325, Aug. 23, 2006; 84 FR 29966, June 25, 2019] | (a) This part may be cited by the short title: “Safeguard Regulations.” This title shall be understood to include both the regulations and administrative instructions in this part. (b) Words used in the singular form in this part shall be deemed to import the plural and vice versa as the case may demand. For purposes of this part, unless the context otherwise requires, the following terms shall be construed, respectively, to mean: Administrative instructions. Published documents set forth in this part relating to the enforcement of this part, and issued under authority thereof by the Deputy Administrator. Biological control organism. Any enemy, antagonist, or competitor used to control a plant pest or noxious weed. Brought in for temporary stay where unloading or landing is not intended. Brought in by carrier but not intended to be unloaded or landed from such carrier. This phrase includes movement (i) departing from the United States on the same carrier directly from the point of arrival therein; and (ii) transiting a part of the United States before departure therefrom, and applies whether movement under Customs procedure is as residue cargo or follows some form of Customs entry. Carrier; means of conveyance. Automobile, truck, animal-drawn vehicle, railway car, aircraft, ship, or other means of transportation. Customs. The U.S. Customs Service, Department of the Treasury, or, with reference to Guam, the Customs Office of the Government of Guam. Deputy Administrator. The Deputy Administrator of the Plant Protection and Quarantine Programs or any employee of the Plant Protection and Quarantine Programs delegated to act in his or her stead. Foreign trade zone. A formally prescribed area containing various physical facilities located in or adjacent to ports of entry under the jurisdiction of the United States and established, operated, and maintained as a foreign trade zone pursuant to the Foreign-Trade Zones Act of June 18, 1934 (48 Stat. 998-1003; 19 U.S.C. 81a-81u), as amended, wherein foreign me… | ||||||
| 7:7:5.1.1.1.12.0.47.10 | 7 | Agriculture | III | 352 | PART 352—PLANT QUARANTINE SAFEGUARD REGULATIONS | § 352.10 Inspection; safeguards; disposal. | APHIS | [25 FR 1929, Mar. 5, 1960, as amended at 36 FR 24917, Dec. 24, 1971; 37 FR 10554, May 25, 1972; 62 FR 65009, Dec. 10, 1997; 66 FR 21059, Apr. 27, 2001; 75 FR 4253, Jan. 26, 2010; 75 FR 68952, Nov. 10, 2010; 84 FR 29966, June 25, 2019] | (a) Inspection and release. Prohibited and restricted products and articles subject to this part shall be subject to inspection at the port of first arrival in accordance with § 330.105(a) of this chapter and shall not be released by Customs officers for unloading, landing, or other onward movement or entry until released by an inspector or a Customs officer on behalf of an inspector in accordance with the procedure prescribed in § 330.105(a) of this chapter. If diversion or change of Customs entry is not permitted for any movements authorized under this part, the inspector at the original port of Customs entry shall appropriately endorse Customs documents to show that fact. However, the inspector at the U.S. port of export may approve diversion or change of Customs entry to permit movement to a different foreign country, or entry into the United States, subject to all other applicable requirements under this part or parts 319, 330, or 360 of this chapter. If diversion or change of Customs entry is desired at a Customs port in the United States where there is no inspector, the owner may apply to the Plant Protection and Quarantine Programs 2 for information as to applicable conditions. If diversion or change of Customs entry is desired at port, confirmation will be given by the Plant Protection and Quarantine Programs to the appropriate Customs officers and Plant Protection and Quarantine Programs inspectors. 2 The Deputy Administrator, Plant Protection and Quarantine Programs, Animal and Plant Health Inspection Service, U.S. Department of Agriculture, Washington, DC 20250. (b) Safeguards. (1) The unloading, landing, retention on board as stores and furnishings or cargo, transshipment and exportation, transportation and exportation, onward movment to the port of entry as residue cargo or under a Customs entry for immediate transportation, and other movement or possession within the United States of prohibited or restricted products and articles under this part shall be subject to such safeguards as m… | ||||||
| 7:7:5.1.1.1.12.0.47.11 | 7 | Agriculture | III | 352 | PART 352—PLANT QUARANTINE SAFEGUARD REGULATIONS | § 352.11 Mail. | APHIS | [25 FR 1929, Mar. 5, 1960, as amended at 75 FR 68952, Nov. 10, 2010; 84 FR 29966, June 25, 2019] | (a) Transit mail. (1) Plants, plant products, plant pests, biological control organisms, noxious weeds, soil, or other products or articles which arrive in the United States in closed dispatches by international mail or international parcel post and which are in transit through the United States to another country shall be allowed to move through the United States without further permit than the authorization contained in this section. Notice of arrival shall not be required as other documentation meets the requirement for this notice. (2) Inspectors ordinarily will not inspect transit mail or parcel post, whether transmitted in open mail or in closed dispatches. They may do so if it comes to their attention that any such mail or parcel post contains prohibited or restricted products or articles which require safeguard action. Inspection and disposal in such cases will be made in accordance with this part and part 330 of this chapter, and in conformity with regulations and procedures of the Post Office Department for handling transit mail and parcel post. (b) Importation for exportation. Plants and plant products to be imported for exportation, by mail, will be handled under permit in accordance with Part 351 of this chapter. | ||||||
| 7:7:5.1.1.1.12.0.47.12 | 7 | Agriculture | III | 352 | PART 352—PLANT QUARANTINE SAFEGUARD REGULATIONS | § 352.12 Baggage. | APHIS | Products or articles subject to this part which are contained in baggage shall be subject to the requirements of this part in the same manner as cargo. | |||||||
| 7:7:5.1.1.1.12.0.47.13 | 7 | Agriculture | III | 352 | PART 352—PLANT QUARANTINE SAFEGUARD REGULATIONS | § 352.13 Certain conditions under which change of Customs entry or diversion is permitted. | APHIS | [25 FR 1929, Mar. 5, 1960, as amended at 62 FR 65009, Dec. 10, 1997; 66 FR 21059, Apr. 27, 2001; 75 FR 68952, Nov. 10, 2010; 84 FR 29967, June 25, 2019] | When plants, plant products,plant pests, biological control organisms, noxious weeds, soil, or other products or articles released for exportation, transshipment and exportation, or transportation and exportation, under this part, have met all applicable permit and other requirements for importation, including inspection and treatment, as provided in part 319, 330, or 360 of this chapter, the form of Customs entry may be changed and the shipment may be diverted at any time to permit delivery of the products and articles to a destination in the United States, so far as the requirements in this part are involved. The Customs officer concerned at the original port of Customs entry shall be informed by the inspector that such release has been made and that such change of entry or diversion is approved under this part by appropriate endorsement of Customs documents. | ||||||
| 7:7:5.1.1.1.12.0.47.14 | 7 | Agriculture | III | 352 | PART 352—PLANT QUARANTINE SAFEGUARD REGULATIONS | § 352.14 Costs. | APHIS | [56 FR 14844, Apr. 12, 1991] | All costs incident to the inspection, handling, safeguarding, or other disposal of prohibited or restricted products or articles under the provisons in this part shall be borne by the owner. Services of the inspector during regularly assigned hours of duty at the usual places of duty shall be furnished without cost to the person requesting the services, unless a user fee is payable under § 354.3 of this chapter. | ||||||
| 7:7:5.1.1.1.12.0.47.15 | 7 | Agriculture | III | 352 | PART 352—PLANT QUARANTINE SAFEGUARD REGULATIONS | § 352.15 Caution. | APHIS | [25 FR 1929, Mar. 5, 1960, as amended at 75 FR 68952, Nov. 10, 2010; 84 FR 29967, June 25, 2019] | In applying safeguards or taking other measures prescribed under the provisions in this part, it should be understood that inexactness or carelessness may result in injury or damage. It should also be understood by the owners that emergency measures prescribed by the inspector to safeguard against plant pest, noxious weed, or biological control organism dissemination may have adverse effects on certain products and articles and that they will take the calculated risk of such adverse effects of authorized measures. | ||||||
| 7:7:5.1.1.1.12.0.47.16 | 7 | Agriculture | III | 352 | PART 352—PLANT QUARANTINE SAFEGUARD REGULATIONS | §§ 352.16-352.28 [Reserved] | APHIS | ||||||||
| 7:7:5.1.1.1.12.0.47.17 | 7 | Agriculture | III | 352 | PART 352—PLANT QUARANTINE SAFEGUARD REGULATIONS | § 352.29 Administrative instructions: Avocados from Mexico. | APHIS | [52 FR 27671, July 23, 1987, as amended at 54 FR 43167, Oct. 23, 1989] | Avocados from Mexico may be moved through the United States to destinations outside the United States only in accordance with this section. (a) Permits. Before moving the avocados through the United States, the owner must obtain a formal permit in accordance with § 352.6 of this part. (b) Ports. The avocados may enter the United States only at the following ports: Galveston or Houston, Texas; the border ports of Nogales, Arizona, or Brownsville, Eagle Pass, El Paso, Hidalgo, or Laredo, Texas; or at other ports within that area of the United States specified in paragraph (f) of this section. (c) Notice of arrival. At the port of arrival, the owner must provide notification of the arrival of the avocados in accordance with § 352.7 of this part. (d) Inspection. The owner must make the avocados available for examination by an inspector. The avocados may not be moved from the port of arrival until released by an inspector. (e) Shipping requirements. The avocados must be moved through the United States either by air or in a refrigerated truck or refrigerated rail car or in refrigerated containers on a truck or rail car. If the avocados are moved in refrigerated containers on a truck or rail car, an inspector must seal the containers with a serially numbered seal at the port of arrival. If the avocados are removed in a refrigerated truck or refrigerated rail car, an inspector must seal the truck or rail car with a serially numbered seal at the port of arrival. If the avocados are transferred to another vehicle or container in the United States, an inspector must be present to supervise the transfer and must apply a new serially numbered seal. The avocados must be moved through the United States under Customs bond. (f) Shipping areas. Avocados moved by truck or rail car may transit only that area of the United States bounded on the west and south by a line extending from El Paso, Texas, to Salt Lake City, Utah, to Portland, Oregon, and due west from Portland; and on the east and south by a line extendin… | ||||||
| 7:7:5.1.1.1.12.0.47.18 | 7 | Agriculture | III | 352 | PART 352—PLANT QUARANTINE SAFEGUARD REGULATIONS | § 352.30 Untreated oranges, tangerines, and grapefruit from Mexico. | APHIS | [25 FR 1929, Mar. 5, 1960, as amended at 36 FR 24917, Dec. 24, 1971; 37 FR 10554, May 25, 1972; 55 FR 23066, June 6, 1990; 56 FR 13066, Mar. 29, 1991; 67 FR 46578, July 16, 2002; 71 FR 49325, Aug. 23, 2006; 72 FR 39528, July 18, 2007; 75 FR 4253, Jan. 26, 2010; 84 FR 29967, June 25, 2019] | The following provisions shall apply to the movement into or through the United States under this part of untreated oranges, tangerines, and grapefruit from Mexico in transit to foreign countries via United States ports on the Mexican border. (a) Untreated fruit; general —(1) Permit and notice of arrival required. The owner shall, in advance of shipment of untreated oranges, tangerines, or grapefruit from Mexico via United States ports to any foreign country, procure a formal permit as provided in § 352.6, or application for permit may be submitted to the inspector at the port in the United States through which the shipment will move. Notice of arrival of such fruit shall be submitted as required by § 352.7. (2) Origin: period of entry. Such fruit may enter from any State in Mexico throughout the year, in accordance with requirements of this section and other applicable provisions in this part. (3) Cleaning refrigerated containers prior to return to the United States from Canada. Refrigerated containers that have been used to transport untreated oranges, tangerines, or grapefruit from Mexico through the United States to Canada shall be carefully swept and freed from all fruit, as well as boxes and rubbish, by the carrier involved prior to reentry into the United States. (4) Inspection; safeguards. (i) Each shipment under paragraph (a) of this section shall be subject to such inspections and safeguards as are required by this section and such others as may be prescribed by the inspector pursuant to § 352.10. (ii) Untreated oranges, tangerines, and grapefruit arriving from Mexico at authorized ports in the United States for movement to a foreign country shall be loaded into refrigerated containers and preinspected by an inspector for freedom of citrus leaves before entry into the United States or be accompanied by an acceptable certificate from an inspector as to such freedom. Refrigerated containers loaded with untreated oranges, tangerines, and grapefruit that are not free of such leaves will be den… | ||||||
| 7:7:5.1.1.1.12.0.47.2 | 7 | Agriculture | III | 352 | PART 352—PLANT QUARANTINE SAFEGUARD REGULATIONS | § 352.2 Purpose; relation to other regulations; applicability; preemption of State and local laws. | APHIS | [25 FR 1929, Mar. 5, 1960, as amended at 62 FR 65009, Dec. 10, 1997; 66 FR 21059, Apr. 27, 2001; 75 FR 68952, Nov. 10, 2010; 84 FR 29966, June 25, 2019] | (a) Importations of plants, plant products, plant pests, biological control organisms, noxious weeds, soil, and other products and articles that may be infested or infected by or contain plant pests, biological control organisms, or noxious weeds are exempt from the prohibitions or restrictions contained in parts 319, 330, and 360 of this chapter if they meet one of the conditions in paragraphs (a)(1) through (a)(4) of this section and are moved into the United States and handled in compliance with this part. Provided: That these exemptions do not apply to cotton and covers imported into the United States from any country for exportation or transshipment and exportation or transportation and exportation as provided in §§ 319.8 through 319.8-26 of this chapter. Moreover, the applicable provisions of §§ 330.100 through 330.109 and 330.400 of this chapter also apply to products and articles subject to this part. (1) They are brought in temporarily where loading and landing is not intended; (2) They are unloaded or landed for transshipment and exportation; (3) They are unloaded or landed for transportation and exportation; or (4) They are intended for unloading and entry at a port other than the port of arrival. (b) Prohibited or restricted products and articles offered for and refused entry into the United States under parts 319, 330, or 360 of this chapter are subject to the applicable provisions in this part regarding their subsequent handling in this country. (c)(1) The provisions in this part apply whether the controls over arrival, temporary stay, unloading, landing, transshipment and exportation, or transportation and exportation, or other movement or possession in the United States and Guam are maintained by entry or other procedures of the U.S. Customs Service, Department of the Treasury, or the Customs Office of the Government of Guam, respectively. Such provisions will apply to arrivals in the United States, including arrivals in a foreign trade zone in the United States to which admission is sough… | ||||||
| 7:7:5.1.1.1.12.0.47.3 | 7 | Agriculture | III | 352 | PART 352—PLANT QUARANTINE SAFEGUARD REGULATIONS | § 352.3 Enforcement and administration. | APHIS | [25 FR 1929, Mar. 5, 1960, as amended at 66 FR 21059, Apr. 27, 2001; 75 FR 68952, Nov. 10, 2010; 84 FR 29966, June 25, 2019] | (a) Plants, plant products, plant pests, biological control organisms, noxious weeds, soil, and other products and articles subject to the regulations in this part that are unloaded, landed, or otherwise brought or moved into or through the United States in violation of this part may be seized, destroyed, or otherwise disposed of in accordance with section 414 of the Plant Protection Act (7 U.S.C. 7714). Any person who unloads, lands, or otherwise brings or moves into or through the United States any regulated plants, plant products, plant pests, biological control organisms, noxious weeds, soil, or other products or articles in violation of this part will be subject to prosecution under the applicable provisions of law. (b) Whenever the Deputy Administrator of the Plant Protection and Quarantine Programs shall find that existing conditions of danger of plant pest escape or dissemination involved in the arrival, unloading, landing, or other movement, or possession in the United States of plants, plant products, plant pests, biological control organisms, noxious weeds, soil, or other products or articles subject to the regulations in this part, make it safe to modify by making less stringent the restrictions contained in any such regulation, he shall publish such findings in administrative instructions, specifying the manner in which the regulations shall be made less stringent with respect thereto, whereupon such modification shall become effective; or he may, upon request in specific cases, when the public interests will permit, authorize arrival, unloading, landing, or other movement, or possession in the United States under conditions that are less stringent than those contained in the regulations in this part. (c) The Deputy Administrator also may set forth and publish, in administrative instructions, requirements and conditions for any class of products or articles supplemental to the regulations in this part, and may promulgate interpretations of this part. (d) The Deputy Administrator shall employ proce… | ||||||
| 7:7:5.1.1.1.12.0.47.4 | 7 | Agriculture | III | 352 | PART 352—PLANT QUARANTINE SAFEGUARD REGULATIONS | § 352.4 Documentation. | APHIS | (a) Manifest. Immediately upon the arrival of a carrier in the United States the owner shall make available to the inspector for examination a complete manifest or other documentation from which the inspector may determine whether there are on board any prohibited or restricted products or articles subject to this part, other than accompanied baggage and mail. (b) Other documentation. Any notifications, reports, and similar documentation not specified in the regulations in this part, but necessary to carry out the purpose of the regulations, will be prescribed in administrative instructions. (c) Procedure after examination of documents. After examination of the carrier cargo manifest or other documentation the inspector may notify the owner and the Customs officer that certain products or articles on board the carrier are subject to this part and may not be unloaded or landed for any purpose pending plant quarantine inspection. In such case the owner shall not unload or land such products or articles without authorization by an inspector. | |||||||
| 7:7:5.1.1.1.12.0.47.5 | 7 | Agriculture | III | 352 | PART 352—PLANT QUARANTINE SAFEGUARD REGULATIONS | § 352.5 Permit; requirement, form and conditions. | APHIS | [25 FR 1929, Mar. 5, 1960, as amended at 62 FR 65009, Dec. 10, 1997; 66 FR 21059, Apr. 27, 2001; 75 FR 68952, Nov. 10, 2010; 84 FR 29966, June 25, 2019] | (a) General. (1) Permits are required for the arrival, unloading or landing, or other movement into or through the United States of plants, plant products, plant pests, biological control organisms, noxious weeds, and soil subject to this part. The permit may consist of a general authorization as set out in paragraph (b), (c), or (d) of this section or § 352.11, or it may be a specific permit. A specific permit may be formal or oral except as a formal permit is required by paragraph (c) or (e) of this section. The Deputy Administrator may in administrative instructions require specific or formal permits for any class of products or articles subject to this part. (2) A formal permit may be issued in prescribed form, in letter form, or a combination thereof. A rubber stamp impression or other endorsement made by the inspector on pertinent Customs documents covering the products or articles involved may constitute the formal permit in appropriate cases. (b) Permit for prohibited or restricted products or articles brought in for temporary stay where unloading or landing in the United States is not intended. No permit other than the authorization contained in this paragraph shall be required for bringing into the United States any plants, plant products, plant pests, biological control organisms, noxious weeds, or soil subject to this part for temporary stay where unloading or landing in the United States is not intended, e.g., in connection with residue cargo movement under Customs procedure, or in connection with Customs entry for exportation or for transportation and exportation. This authorization also includes transshipment of products and articles under this paragraph from a carrier directly to another carrier of the same company when necessitated by an emergency or operating requirement and effected in accordance with safeguards prescribed in writing or orally by the inspector under § 352.10. (c) Permit for prohibited or restricted products or articles unloaded or landed for immediate transshipment and … | ||||||
| 7:7:5.1.1.1.12.0.47.6 | 7 | Agriculture | III | 352 | PART 352—PLANT QUARANTINE SAFEGUARD REGULATIONS | § 352.6 Application for permit and approval or denial thereof. | APHIS | [25 FR 1929, Mar. 5, 1960, as amended at 36 FR 24917, Dec. 24, 1971; 37 FR 10554, May 25, 1972; 48 FR 57466, Dec. 30, 1983; 59 FR 67611, Dec. 30, 1994; 75 FR 68952, Nov. 10, 2010; 84 FR 29966, June 25, 2019] | (a) Plants and plant products (including noxious weeds). Except as otherwise provided in this paragraph, any person desiring to unload or land, or otherwise move into or through the United States, any plants or plant products for which a specific permit is required by § 352.5, shall in the case of prohibited plants or plant products, and should in the case of restricted plants or plant products, in advance of arrival in the United States of the plants or plant products, submit an application for a permit to the Plant Protection and Quarantine Programs, 1 stating such of the following information as is relevant: The name and address of the importer, the approximate quantity and kind of plants and plant products it is desired to import under this part, the country where grown, the United States port of arrival, the United States port of export, the proposed routing from the port of arrival to the port of exportation, means of transportation to be employed ( i.e. , mail, air mail, express, air express, freight, air freight, baggage), and the name and address of the agent representing the importer. Applications may be made on forms provided for the purpose by the Plant Protection and Quarantine Programs, or orally, or by letter, telegram, or other means of communication furnishing all the information required by this paragraph. Applications need not be made for shipments handled under general authorizations set forth in § 352.5 (b), (c), or (d), or in § 352.11. 1 Application for such permits should be addressed to the Animal and Plant Health Inspection Service, Plant Protection and Quarantine, Port Operations, Permit Unit, 4700 River Road, Unit 136, Riverdale, Maryland 20737-1236. (b) Plant pests. Any person desiring to unload or land, or otherwise move into or through the United States, any plant pest for which a specific permit is required by § 352.5 shall, in advance of the arrival of the plant pests in the United States, submit an application to the Plant Protection and Quarantine Programs for a perm… | ||||||
| 7:7:5.1.1.1.12.0.47.7 | 7 | Agriculture | III | 352 | PART 352—PLANT QUARANTINE SAFEGUARD REGULATIONS | § 352.7 Notice of arrival. | APHIS | [81 FR 40150, June 21, 2016] | Immediately upon arrival of any shipment of plants or plant products (including noxious weeds) subject to this part and covered by a specific permit, the importer shall submit to an inspector notice of such arrival using a form provided for that purpose (Form PPQ-368) and, where relevant, the proposed routing to the proposed U.S. port of exit. Forms will be submitted using a U.S. Government electronic information exchange system or other authorized method. Notice of arrival shall not be required for other products or articles subject to this part since other available documentation meets the requirement for this notice. | ||||||
| 7:7:5.1.1.1.12.0.47.8 | 7 | Agriculture | III | 352 | PART 352—PLANT QUARANTINE SAFEGUARD REGULATIONS | § 352.8 Marking requirements. | APHIS | Prohibited and restricted products and articles subject to this part shall be adequately marked or otherwise identified by documentation to indicate their nature. | |||||||
| 7:7:5.1.1.1.12.0.47.9 | 7 | Agriculture | III | 352 | PART 352—PLANT QUARANTINE SAFEGUARD REGULATIONS | § 352.9 Ports. | APHIS | [25 FR 1929, Mar. 5, 1960, as amended at 75 FR 68952, Nov. 10, 2010; 84 FR 29966, June 25, 2019] | The arrival, unloading, landing, or possession of plants, plant products,plant pests, biological control organisms, noxious weeds, soil, or other products or articles subject to this part shall not be allowed at points within the United States other than at the ports specified in the Customs Regulations in 19 CFR 1.1 and 19 CFR 6.13, and Agana, Guam, or such other ports as may be named in permits or administrative instructions. Restrictions on the ports which may be used for particular types of handling of any products or articles subject to this part may be specified generally in administrative instructions or in permits in specific cases. When ports are specified in permits or otherwise, the arrival, unloading, landing, or possession of the products or articles involved at other ports will not be allowed except as the inspector may authorize changes in the ports specified. | ||||||
| 9:9:2.0.2.1.32.1.17.1 | 9 | Animals and Animal Products | III | A | 352 | PART 352—EXOTIC ANIMALS; VOLUNTARY INSPECTION | A | Subpart A—Exotic Animals | § 352.1 Definitions. | FSIS | [54 FR 1330, Jan. 13, 1989, as amended at 86 FR 37218, July 15, 2021] | The definitions in § 301.2, not otherwise defined in this part, are incorporated into this part. In addition to those definitions, the following definitions will be applicable to the regulations in this part. (a) Act means the applicable provisions of the Agricultural Marketing Act of 1946, as amended (60 Stat. 1087, as amended; 7 U.S.C. 1621 et seq. ). (b) Acceptable means suitable for the purpose intended and acceptable to the Food Safety and Inspection Service. (c) Antelope means any of various ruminant deerlike mammals (family Bovidae) chiefly of Africa and southwest Asia that have a slender lean build and usually horns directed upward and backward. (d) Applicant means any interested party who requests any inspection service. (e) Bison (Bison bison), commonly known as the American bison or buffalo, is a species of the genus Bison native to North America. Bison includes catalo or cattalo. (f) Buffalo refers to a subtribe Bubalina of the tribe Bovini within the subfamily Bovinae that includes the water buffalo ( Bubalus bubalis) and Cape buffalo (Syncerus caffer ). (g) Catalo or Cattalo means any hybrid animal with bison ( Bison bison ) appearance resulting from direct crossbreeding of bison ( Bison bison ) and cattle ( Bos taurus ). (h) Condition means any condition, including, but not limited to, the state of preservation, cleanliness, or soundness of any product or the processing, handling, or packaging which may affect such product. (i) Condition and wholesomeness means the condition of any product, its healthfulness and fitness for human food. (j) Deer refers to the any farm-raised species of the family Cervidae. (k) Exotic animal means any reindeer, elk, deer, antelope, water buffalo, bison, buffalo, or yak. (l) Elk ( Cervus canadensis ) refers to one of the largest species within the family Cervidae. It is native to North America and in high mountains of Central Asia. (m) Exotic animal inspection service means the personnel who are engaged in the administration… | |||
| 9:9:2.0.2.1.32.1.17.10 | 9 | Animals and Animal Products | III | A | 352 | PART 352—EXOTIC ANIMALS; VOLUNTARY INSPECTION | A | Subpart A—Exotic Animals | § 352.10 Ante-mortem inspection. | FSIS | [54 FR 1333, Jan. 13, 1989] | An ante-mortem inspection of an exotic animal shall, where and to the extent considered necessary by the Administrator and under such instructions as he may issue from time to time, be made on the day of slaughter of an exotic animal, in one of the following listed ways or as determined by the Administrator. Humane handling of an exotic animal during ante-mortem inspection shall be in accordance with the provisions contained in 9 CFR 313.2. Immediately after the animal is stunned or killed, it shall be shackled, hoisted, stuck and bled. (a) To be performed on an exotic animal in the field in a designated area of an exotic animal producer's premises. (1) Reindeer, elk, deer, antelope, bison and water buffalo are eligible for field ante-mortem inspection. The field ante-mortem designated area must be approved by the Regional Director or designee prior to rendition of the service. (2) Any person who desires to receive field ante-mortem inspection must provide: (i) Notification from an official exotic animal establishment to the Regional Director or designee. (ii) A field ante-mortem designated area. (iii) A stunning/slaughtering area which is in a condition that minimizes the possibility of soiling the animal when stunned/slaughtered and bled as determined by the inspector. (iv) A transport vehicle that is as sanitary as practicable as determined by the inspector. (3) The ante-mortem inspector shall determine the acceptableness and safety of performing field ante-mortem inspection. If, in the opinion of the ante-mortem inspector, an unsafe circumstance exists at the time of field ante-mortem inspection, the service shall be denied. (4) An exotic animal that, in the ante-mortem inspector's opinion, does not pass ante-mortem inspection must be withheld from slaughter. (5) Stunning to render the animal unconscious shall be in accordance with 9 CFR 313.15 or 313.16. (6) All stunned/slaughtered and bled exotic animals shall be tagged with a “U.S. Suspect” tag in an ear by the ante-mortem inspector or designee … | |||
| 9:9:2.0.2.1.32.1.17.11 | 9 | Animals and Animal Products | III | A | 352 | PART 352—EXOTIC ANIMALS; VOLUNTARY INSPECTION | A | Subpart A—Exotic Animals | § 352.11 Post-mortem inspection. | FSIS | [54 FR 1333, Jan. 13, 1989] | (a) Post-mortem inspection of reindeer, elk, deer, antelope, bison and water buffalo shall be conducted in accordance with the provisions contained in 9 CFR part 310 or as determined by the Administrator. (b) The post-mortem examination of field ante-mortem-inspected exotic animals must occur in the shortest length of time practicable and on the day that field ante-mortem inspection is performed to minimize the changes in the carcass which can affect the post-mortem examination, disposition and wholesomeness of the carcass and its parts. (c) The post-mortem veterinarian shall inspect and make the disposition of all incoming “U.S. Suspect” tagged exotic animals. | |||
| 9:9:2.0.2.1.32.1.17.12 | 9 | Animals and Animal Products | III | A | 352 | PART 352—EXOTIC ANIMALS; VOLUNTARY INSPECTION | A | Subpart A—Exotic Animals | § 352.12 Disposal of diseased or otherwise adulterated carcasses and parts. | FSIS | This shall be conducted in accordance with the provisions contained in 9 CFR part 311. | ||||
| 9:9:2.0.2.1.32.1.17.13 | 9 | Animals and Animal Products | III | A | 352 | PART 352—EXOTIC ANIMALS; VOLUNTARY INSPECTION | A | Subpart A—Exotic Animals | § 352.13 Handling and disposal of condemned or other inedible exotic animal products at official exotic animal establishments. | FSIS | This shall be conducted in accordance with the provisions contained in 9 CFR part 314. | ||||
| 9:9:2.0.2.1.32.1.17.14 | 9 | Animals and Animal Products | III | A | 352 | PART 352—EXOTIC ANIMALS; VOLUNTARY INSPECTION | A | Subpart A—Exotic Animals | § 352.14 Entry into official establishments; reinspection and preparation of products. | FSIS | This shall be conducted in accordance with the provisions contained in 9 CFR 318.1, 318.2, and 318.3. | ||||
| 9:9:2.0.2.1.32.1.17.15 | 9 | Animals and Animal Products | III | A | 352 | PART 352—EXOTIC ANIMALS; VOLUNTARY INSPECTION | A | Subpart A—Exotic Animals | § 352.15 Records, registration, and reports. | FSIS | This shall be conducted or maintained in accordance with the provisions contained in 9 CFR 320.1 through 320.7. | ||||
| 9:9:2.0.2.1.32.1.17.16 | 9 | Animals and Animal Products | III | A | 352 | PART 352—EXOTIC ANIMALS; VOLUNTARY INSPECTION | A | Subpart A—Exotic Animals | § 352.16 Exports. | FSIS | This shall be conducted in accordance with the provisions contained in 9 CFR 322.1 through 322.5. | ||||
| 9:9:2.0.2.1.32.1.17.17 | 9 | Animals and Animal Products | III | A | 352 | PART 352—EXOTIC ANIMALS; VOLUNTARY INSPECTION | A | Subpart A—Exotic Animals | § 352.17 Transportation. | FSIS | This shall be conducted in accordance with the provisions contained in §§ 325.1 through 325.21. | ||||
| 9:9:2.0.2.1.32.1.17.18 | 9 | Animals and Animal Products | III | A | 352 | PART 352—EXOTIC ANIMALS; VOLUNTARY INSPECTION | A | Subpart A—Exotic Animals | § 352.18 Cooperation of States in Federal programs. | FSIS | Under the “Talmadge-Aiken Act” of September 28, 1962 (7 U.S.C. 450), the Administrator is authorized to utilize employees and facilities of States in carrying out Federal functions. | ||||
| 9:9:2.0.2.1.32.1.17.2 | 9 | Animals and Animal Products | III | A | 352 | PART 352—EXOTIC ANIMALS; VOLUNTARY INSPECTION | A | Subpart A—Exotic Animals | § 352.2 Type of service available. | FSIS | [54 FR 1330, Jan. 13, 1989] | Upon application, in accordance with §§ 352.3, 352.4, and 352.5, the following type of service may be furnished under the regulations in this part: (a) Voluntary Inspection Service. An inspection and certification service for wholesomeness relating to the slaughter and processing of exotic animals and the processing of exotic animal products. All provisions of this part shall apply to the slaughter of exotic animals, and the preparation, labeling, and certification of the exotic animal meat and exotic animal products processed under this exotic animal inspection service. (b) Only exotic animals which have had ante-mortem inspection as described under this part and which are processed in official exotic animal establishments in accordance with this part may be marked inspected and passed. (c) Exotic animals, exotic animal meat and meat food products shall be handled in an official exotic animal establishment to ensure separation and identity of the exotic animal or exotic animal meat and meat food products until they are shipped from the official exotic animal establishment to prevent commingling with other species. | |||
| 9:9:2.0.2.1.32.1.17.3 | 9 | Animals and Animal Products | III | A | 352 | PART 352—EXOTIC ANIMALS; VOLUNTARY INSPECTION | A | Subpart A—Exotic Animals | § 352.3 Application by official exotic animal establishment for inspection services. | FSIS | [54 FR 1331, Jan. 13, 1989] | (a) Any person desiring to process an exotic animal, exotic animal carcasses, exotic animal meat and meat food products in an establishment under exotic animal inspection service must receive approval of such establishment and facilities as an official exotic animal establishment prior to the rendition of such service. An application for inspection service to be rendered in an official exotic animal establishment shall be approved in accordance with the provisions contained in §§ 304.1 and 304.2 of subchapter A of this chapter. (b) Initial survey. When an application has been filed for exotic animal inspection service, the Regional Director or designee, shall examine the establishment, premises, and facilities. | |||
| 9:9:2.0.2.1.32.1.17.4 | 9 | Animals and Animal Products | III | A | 352 | PART 352—EXOTIC ANIMALS; VOLUNTARY INSPECTION | A | Subpart A—Exotic Animals | § 352.4 Application for ante-mortem inspection service in the field. | FSIS | [54 FR 1331, Jan. 13, 1989] | Any exotic animal producer desiring field ante-mortem exotic animal inspection service must receive approval of the field ante-mortem designated area from the Regional Director or designee prior to the rendition of such service. An application seeking approval of the designated area for ante-mortem inspection shall be obtained from the Regional Director, and completed and submitted to the Regional Director. (a) An initial application for field ante-mortem exotic animal inspection service shall be made by an official exotic animal establishment to the Regional Director. Subsequent requests shall be made by the official exotic animal establishment on behalf of an exotic animal producer to the Regional Director in one of the following manners: (1) telephone, (2) telegraph, (3) mail, or (4) in person as determined by the Regional Director. (b) Upon receipt of the completed application, the Regional Director or designee shall examine the field ante-mortem designated area and facilities for approval of the designated area. (c) All fees involved for the approval of the designated area, including but not limited to any travel, per diem costs, and time required to perform such approval services, shall be paid directly by the applicant to the Regional Director. | |||
| 9:9:2.0.2.1.32.1.17.5 | 9 | Animals and Animal Products | III | A | 352 | PART 352—EXOTIC ANIMALS; VOLUNTARY INSPECTION | A | Subpart A—Exotic Animals | § 352.5 Fees and charges. | FSIS | [50 FR 41847, Oct. 16, 1988, as amended at 53 FR 13398, Apr. 22, 1988; 54 FR 6390, Feb. 10, 1989] | (a) Fees and charges for service under the regulations in this part shall be paid by the applicant for the service in accordance with this section. (b) The fees and charges provided for in this section shall be paid by check, draft, or money order payable to the “Treasurer of the United States” and shall be remitted promptly to the Regional Director upon furnishing to the applicant a statement as to the amount due. (c) The fees to be charged and collected for service under the regulations in this part shall be at the rates specified in §§ 391.2, 391.3, and 391.4 respectively for base time; for overtime including Saturdays, Sundays, and holidays; and for certain laboratory services which are not covered under the base time, overtime, and/or holiday costs. Such fees shall cover the costs of the service and shall be charged for the time required to render such service, including, but not limited to, the time required for the travel of the inspector or inspectors in connection therewith during the regularly scheduled administrative workweek. (d) Charges may also be made to cover other expenses incurred by the Service in connection with the furnishing of the service. (e) Fees and charges for any inspection pursuant to a cooperative agreement with any State shall be paid in accordance with the terms of such cooperative agreement. | |||
| 9:9:2.0.2.1.32.1.17.6 | 9 | Animals and Animal Products | III | A | 352 | PART 352—EXOTIC ANIMALS; VOLUNTARY INSPECTION | A | Subpart A—Exotic Animals | § 352.6 Denial or withdrawal of inspection service. | FSIS | [50 FR 41847, Oct. 16, 1985, as amended at 54 FR 1331, Jan. 13, 1989] | (a) For miscellaneous reasons. An application or a request for service may be rejected, or the benefits of the service may be otherwise denied to, or withdrawn from, any person, without a hearing by the appropriate Regional Director: (1) for administrative reasons such as the nonavailability of personnel to perform the service; (2) for the failure of payment for service; (3) in case the application or request relates to exotic animals or exotic animal products which are not eligible for service under this part; (4) for failure to maintain the designated area or the plant in a state of repair approved by the Service; (5) for the use of operating procedures which are not in accordance with the regulations of this part; (6) for alterations of buildings, facilities, or equipment which cannot be approved under the regulations in this part. Notice of such rejection, denial, or withdrawal, and the reasons therefore, shall promptly be given to the person involved. The applicant or recipient shall be notified of such decision to reject an application or request for service or to deny or withdraw the benefits of the service, and the reasons therefor, in writing in the manner prescribed in § 1.147(b) of the rules of practice (7 CFR 1.147(b)), or orally. Such decision shall be effective upon such oral or written notification, whichever is earlier, to the applicant or recipient. If such notification is oral, the person making such decision shall confirm such decision, and the reasons therefor, in writing, as promptly as circumstances permit, and such written confirmation shall be served upon the applicant or recipient in the manner prescribed in § 1.147(b) of the rules of practice (7 CFR 1.147(b)). (b) For disciplinary reasons — Basis for denial or withdrawal. An application or request for service may be denied, or the benefits of the service may be withdrawn from, any person or entity who, or whose officer, employee or agent in the scope of his employment or agency: (1) Has willfully made any misrepresentation or has co… | |||
| 9:9:2.0.2.1.32.1.17.7 | 9 | Animals and Animal Products | III | A | 352 | PART 352—EXOTIC ANIMALS; VOLUNTARY INSPECTION | A | Subpart A—Exotic Animals | § 352.7 Marking and labeling of inspected products. | FSIS | [50 FR 41847, Oct. 16, 1985, as amended at 54 FR 1331, Jan. 13, 1989; 88 FR 2811, Jan. 18, 2023] | Wording and form of inspection mark. This wording shall be contained within a triangle in the form and arrangement shown in this section. The establishment number of the official establishment shall be included in the triangle unless it appears elsewhere on the packaging material. Ordering and manufacture of the triangle brand shall be in accordance with the provisions in 9 CFR 317.3(c) of the Federal meat inspection regulations. The Administrator may approve the use of abbreviations of such inspection mark, and such approved abbreviations shall have the same force and effect as the inspection mark. The inspection mark or approved abbreviation shall be applied, under the supervision of the inspector, to the inspected and passed edible product, packaging material, immediate container or shipping container. When the inspection mark or approved abbreviation is used on packaging material, immediate container or shipping container, it shall be printed on such material or container or on a label to be affixed to the packaging material or container. The name and address of the packer or distributor of such product shall be printed on the packaging material or label. The inspection marks may be stenciled on the container, and when the inspection mark is so stenciled, the name and address of the packer or distributor may be applied by the use of a stencil or rubber stamp. The name and address of the packer or distributor, if prominently shown elsewhere on the packaging material or container, may be omitted from insert labels which bear an official identification if the applicable establishment number is shown. All labels intended for use on inspected and passed exotic animal products must be approved in accordance with Part 412 of this chapter. (a) The inspection mark to be applied to inspected and passed carcasses and parts of carcasses of an exotic animal, and products as therefrom approved by the Administrator, shall be in the form and arrangement as indicated in the example below. 1 The establishment number of … | |||
| 9:9:2.0.2.1.32.1.17.8 | 9 | Animals and Animal Products | III | A | 352 | PART 352—EXOTIC ANIMALS; VOLUNTARY INSPECTION | A | Subpart A—Exotic Animals | § 352.8 Time of inspection in the field and in an official exotic animal establishment. | FSIS | [54 FR 1332, Jan. 13, 1989] | The official exotic animal establishment on behalf of the applicant shall notify the Regional Director or designee, in advance, of the hours when such inspection is desired. Inspection personnel shall have access at all times to every part of any field ante-mortem inspection area and/or official exotic animal establishment to which they are assigned. | |||
| 9:9:2.0.2.1.32.1.17.9 | 9 | Animals and Animal Products | III | A | 352 | PART 352—EXOTIC ANIMALS; VOLUNTARY INSPECTION | A | Subpart A—Exotic Animals | § 352.9 Report of inspection work. | FSIS | [54 FR 1333, Jan. 13, 1989] | Reports of the work of inspection carried on within the field ante-mortem inspection area of an exotic animal producer's premises and/or official exotic animal establishment shall be forwarded to the Administrator by the ante-mortem inspector. The applicant for such inspection shall furnish to the Administrator such information as may be required on forms provided by the Administrator. |
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section_id TEXT PRIMARY KEY,
title_number INTEGER,
title_name TEXT,
chapter TEXT,
subchapter TEXT,
part_number TEXT,
part_name TEXT,
subpart TEXT,
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section_number TEXT,
section_heading TEXT,
agency TEXT,
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source_citation TEXT,
amendment_citations TEXT,
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);
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);