{"database": "openregs", "table": "cfr_sections", "is_view": false, "human_description_en": "where part_number = 352 sorted by section_id", "rows": [["21:21:5.0.1.1.27.1.1.1", 21, "Food and Drugs", "I", "D", "352", "PART 352\u2014SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY]", "A", "Subpart A\u2014General Provisions", "", "\u00a7 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 \u00a7 330.1 of this chapter.\n\n(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\u2014SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY]", "A", "Subpart A\u2014General Provisions", "", "\u00a7 352.3 Definitions.", "FDA", "", "", "", "As used in this part:\n\n(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.\n\n(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.\n\n(1)  Minimal sun protection product.  A sunscreen product that provides a sun protection factor (SPF) value of 2 to under 12.\n\n(2)  Moderate sun protection product.  A sunscreen product that provides an SPF value of 12 to under 30.\n\n(3)  High sun protection product.  A sunscreen product that provides an SPF value of 30 or above.\n\n(c)  Sunscreen active ingredient.  An active ingredient listed in \u00a7 352.10 that absorbs, reflects, or scatters radiation in the UV range at wavelengths from 290 to 400 nanometers.\n\n(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\u2014SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY]", "B", "Subpart B\u2014Active Ingredients", "", "\u00a7 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:\n\n(a) Aminobenzoic acid (PABA) up to 15 percent.\n\n(b) Avobenzone up to 3 percent.\n\n(c) Cinoxate up to 3 percent.\n\n(d) [Reserved]\n\n(e) Dioxybenzone up to 3 percent.\n\n(f) Homosalate up to 15 percent.\n\n(g) [Reserved]\n\n(h) Menthyl anthranilate up to 5 percent.\n\n(i) Octocrylene up to 10 percent.\n\n(j) Octyl methoxycinnamate up to 7.5 percent.\n\n(k) Octyl salicylate up to 5 percent.\n\n(l) Oxybenzone up to 6 percent.\n\n(m) Padimate O up to 8 percent.\n\n(n) Phenylbenzimidazole sulfonic acid up to 4 percent.\n\n(o) Sulisobenzone up to 10 percent.\n\n(p) Titanium dioxide up to 25 percent.\n\n(q) Trolamine salicylate up to 12 percent.\n\n(r) Zinc oxide up to 25 percent.\n\n(f) Ensulizole up to 4 percent.\n\n(g) Homosalate up to 15 percent.\n\n(h) [Reserved]\n\n(i) Meradimate up to 5 percent.\n\n(j) Octinoxate up to 7.5 percent.\n\n(k) Octisalate up to 5 percent.\n\n(l) Octocrylene up to 10 percent.\n\n(m) Oxybenzone up to 6 percent.\n\n(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\u2014SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY]", "B", "Subpart B\u2014Active Ingredients", "", "\u00a7 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.\n\n(a)  Combinations of sunscreen active ingredients.  (1) Two or more sunscreen active ingredients identified in \u00a7 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 \u00a7 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.\n\n(2) Two or more sunscreen active ingredients identified in \u00a7 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 \u00a7 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.\n\n(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 \u00a7 352.10 may be combined with one or more skin protectant active ingredients identified in \u00a7 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 \u00a7 352.60.\n\n(c) [Reserved]\n\n(a)  Combinations of sunscreen active ingredients.  (1) Two or more sunscreen active ingredients identified in \u00a7 352.10(a), (c), (e), (f), (g), and (i) through (r) may be combined with each other in a single product when used in the concentrations established for each ingredient in \u00a7 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.\n\n(2) Two or more sunscreen active ingredients identified in \u00a7 352.10(b), (c), (e), (g), (j) through (m), (o), and (q) may be combined with each other in a single product when used in the concentrations established for each ingredient in \u00a7 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."], ["21:21:5.0.1.1.27.3.1.1", 21, "Food and Drugs", "I", "D", "352", "PART 352\u2014SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY]", "C", "Subpart C\u2014Labeling", "", "\u00a7 352.50 Principal display panel of all sunscreen drug products.", "FDA", "", "", "", "In addition to the statement of identity required in \u00a7 352.52, the following labeling statements shall be prominently placed on the principal display panel:\n\n(a)  For products that do not satisfy the water resistant or very water resistant sunscreen product testing procedures in \u00a7 352.76 \u2014(1)  For products with SPF values up to 30.  \u201cSPF (insert tested SPF value of the product up to 30).\u201d\n\n(2)  For products with SPF values over 30.  \u201cSPF 30\u201d (select one of the following: \u201cplus\u201d or \u201c + \u201d). 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).\n\n(b)  For products that satisfy the water resistant sunscreen product testing procedures in \u00a7 352.76.  (1) (Select one of the following: \u201cWater,\u201d \u201cWater/Sweat,\u201d or \u201cWater/Perspiration\u201d) \u201cResistant.\u201d\n\n(2) \u201cSPF (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 \u00a7 352.76).\u201d\n\n(c)  For products that satisfy the very water resistant sunscreen product testing procedures in \u00a7 352.76.  (1) \u201cVery\u201d (select one of the following: \u201cWater,\u201d \u201cWater/Sweat,\u201d or \u201cWater/Perspiration\u201d) \u201cResistant.\u201d\n\n(2) \u201cSPF (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 \u00a7 352.76).\u201d"], ["21:21:5.0.1.1.27.3.1.2", 21, "Food and Drugs", "I", "D", "352", "PART 352\u2014SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY]", "C", "Subpart C\u2014Labeling", "", "\u00a7 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 \u201csunscreen.\u201d\n\n(b)  Indications.  The labeling of the product states, under the heading \u201cUses,\u201d 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 \u00a7 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.\n\n(1)  For products containing any ingredient in \u00a7 352.10.  (i) \u201c[bullet] \n 1 \n   helps prevent sunburn [bullet] higher SPF gives more sunburn protection\u201d.\n\n1  See \u00a7 201.66(b)(4) of this chapter.\n\n(ii)  For products that satisfy the water resistant testing procedures identified in \u00a7 352.76.  \u201c[bullet] retains SPF after 40 minutes of\u201d (select one or more of the following: \u201cactivity in the water,\u201d \u201csweating,\u201d or \u201cperspiring\u201d).\n\n(iii)  For products that satisfy the very water resistant testing procedures identified in \u00a7 352.76.  \u201c[bullet] retains SPF after 80 minutes of\u201d (select one or more of the following: \u201cactivity in the water,\u201d \u201csweating,\u201d or \u201cperspiring\u201d).\n\n(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 \u00a7 352.10:\n\n(i)  For products that provide an SPF of 2 to under 12.  Select one or both of the following: [\u201c[bullet]\u201d (select one of the following: \u201cprovides minimal,\u201d \u201cprovides minimum,\u201d \u201cminimal,\u201d or \u201cminimum\u201d) \u201cprotection against\u201d (select one of the following: \u201csunburn\u201d or \u201csunburn and tanning\u201d)], or \u201c[bullet] for skin that sunburns minimally\u201d.\n\n(ii)  For products that provide an SPF of 12 to under 30.  Select one or both of the following: [\u201c[bullet]\u201d (select one of the following: \u201cprovides moderate\u201d or \u201cmoderate\u201d) \u201cprotection against\u201d (select one of the following: \u201csunburn\u201d or \u201csunburn and tanning\u201d)], or \u201c[bullet] for skin that sunburns easily\u201d.\n\n(iii)  For products that provide an SPF of 30 or above.  Select one or both of the following: [\u201c[bullet]\u201d (select one of the following: \u201cprovides high\u201d or \u201chigh\u201d) \u201cprotection against\u201d (select one of the following: \u201csunburn\u201d or \u201csunburn and tanning\u201d)], or \u201c[bullet] for skin highly sensitive to sunburn\u201d.\n\n(c)  Warnings.  The labeling of the product contains the following warnings under the heading \u201cWarnings:\u201d\n\n(1)  For products containing any ingredient in \u00a7 352.10.  (i) \u201cWhen using this product [bullet] keep out of eyes. Rinse with water to remove.\u201d\n\n(ii) \u201cStop use and ask a doctor if [bullet] rash or irritation develops and lasts\u201d.\n\n(2)  For products containing any ingredient identified in \u00a7 352.10 marketed as a lip protectant or lipstick.  The external use only warning in \u00a7 201.66(c)(5)(i) of this chapter and the warning in paragraph (c)(1)(i) of this section are not required.\n\n(d)  Directions.  The labeling of the product contains the following statements, as appropriate, under the heading \u201cDirections.\u201d More detailed directions applicable to a particular product formulation (e.g., cream, gel, lotion, oil, spray, etc.) may also be included.\n\n(1)  For products containing any ingredient in \u00a7 352.10.  (i) \u201c[bullet] apply\u201d (select one or more of the following, as applicable: \u201cliberally,\u201d \u201cgenerously,\u201d \u201csmoothly,\u201d or \u201cevenly\u201d) \u201c(insert appropriate time interval, if a waiting period is needed) before sun exposure and as needed\u201d.\n\n(ii) \u201c[bullet] children under 6 months of age: ask a doctor\u201d.\n\n(2)  In addition to the directions provided in \u00a7 352.52(d)(1), the following may be used for products containing any ingredient in \u00a7 352.10.  \u201c[bullet] reapply as needed or after towel drying, swimming, or\u201d (select one of the following: \u201csweating\u201d or \u201cperspiring\u201d).\n\n(3)  If the additional directions provided in \u00a7 352.52(d)(2) are used, the phrase \u201cand as needed\u201d in \u00a7 352.52(d)(1) is not required.\n\n(4)  For products marketed as a lip protectant or lipstick.  The directions in paragraphs (d)(1) and (d)(2) of this section are not required.\n\n(e)  Statement on product performance \u2014(1)  For products containing any ingredient identified in \u00a7 352.10, the following PCD labeling claims may be used under the heading \u201cOther information\u201d or anywhere outside of the \u201cDrug Facts\u201d box or enclosure.\n\n(i)  For products containing active ingredient(s) that provide an SPF value of 2 to under 12.  (Select one of the following: \u201cminimal\u201d or \u201cminimum\u201d) \u201csun protection product.\u201d\n\n(ii)  For products containing active ingredient(s) that provide an SPF value of 12 to under 30.  \u201cmoderate sun protection product.\u201d\n\n(iii)  For products containing active ingredient(s) that provide an SPF value of 30 or above.  \u201chigh sun protection product.\u201d\n\n(2)  For products containing any ingredient identified in \u00a7 352.10, the following labeling statement may be used under the heading \u201cOther information\u201d or anywhere outside of the \u201cDrug Facts\u201d box or enclosure.  \u201cSun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.\u201d Any variation of this statement will cause the product to be misbranded under section 502 of the act.\n\n(f)  Products labeled for use only on specific small areas of the face (e.g., lips, nose, ears, and/or around eyes) and that meet the criteria established in \u00a7 201.66(d)(10) of this chapter.  The title, headings, subheadings, and information described in \u00a7 201.66(c) of this chapter shall be printed in accordance with the following specifications:\n\n(1) The labeling shall meet the requirements of \u00a7 201.66(c) of this chapter except that the title, headings, and information described in \u00a7 201.66(c)(1), (c)(3), and (c)(7) may be omitted, and the headings, subheadings, and information described in \u00a7 201.66(c)(2), (c)(4), (c)(5), and (c)(6) may be presented as follows:\n\n(i) The active ingredients (\u00a7 201.66(c)(2) of this chapter) shall be listed in alphabetical order.\n\n(ii) The heading and the indication required by \u00a7 201.66(c)(4) of this chapter may be limited to: \u201cUse [in bold type] helps protect against sunburn.\u201d For a lip protectant product, the heading and the indication required by \u00a7 201.66(c)(4) may be limited to: \u201cUse [in bold type] helps protect against sunburn and chapped lips.\u201d\n\n(iii) The \u201cexternal use only\u201d warning in \u00a7 201.66(c)(5)(i) of this chapter may be omitted.\n\n(iv) The subheadings in \u00a7 201.66(c)(5)(iii) through (c)(5)(vii) of this chapter may be omitted, provided the information after the heading \u201cWarnings\u201d states: \u201cKeep out of eyes.\u201d and \u201cStop use if skin rash occurs.\u201d\n\n(v) The warning in \u00a7 201.66(c)(5)(x) of this chapter may be limited to the following: \u201cKeep out of reach of children.\u201d\n\n(vi) For a lip protectant product or lipstick, the warnings \u201cKeep out of eyes\u201d in \u00a7 352.52(f)(1)(iv) and \u201cKeep out of reach of children\u201d in \u00a7 352.52(f)(1)(v) and the directions in \u00a7 352.52(d) may be omitted.\n\n(2) The labeling shall be printed in accordance with the requirements of \u00a7 201.66(d) of this chapter except that any requirements related to \u00a7 201.66(c)(1), (c)(3), and (c)(7), and the horizontal barlines and hairlines described in \u00a7 201.66(d)(8), may be omitted."], ["21:21:5.0.1.1.27.3.1.3", 21, "Food and Drugs", "I", "D", "352", "PART 352\u2014SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY]", "C", "Subpart C\u2014Labeling", "", "\u00a7 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.\n\n(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.\n\n(b)  Indications.  The labeling of the product states, under the heading \u201cUses,\u201d 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 \u00a7 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.\n\n(1) In addition, the labeling of the product may contain any of the \u201cother allowable statements\u201d that are identified in the applicable monographs.\n\n(2) For permitted combinations containing a sunscreen and a skin protectant identified in \u00a7 352.20(b), any or all of the applicable indications for sunscreens in \u00a7 352.52(b) and the indication for skin protectants in \u00a7 347.50(b)(2)(i) of this chapter should be used. For products marketed as a lip protectant, the indication in \u00a7 352.52(f)(1)(ii) should be used.\n\n(c)  Warnings.  The labeling of the product states, under the heading \u201cWarnings,\u201d the warning(s) for each ingredient in the combination, as established in the warnings section of the applicable OTC drug monographs, except that the warning for skin protectants in \u00a7 347.50(c)(3) of this chapter is not required for permitted combinations containing a sunscreen and a skin protectant identified in \u00a7 352.20(b). For products marketed as a lip protectant or lipstick, \u00a7 352.52(f)(1)(iii), (f)(1)(iv) (except \u201cKeep out of eyes,\u201d which may be omitted), and (f)(1)(vi) apply.\n\n(d)  Directions.  The labeling of the product states, under the heading \u201cdirections,\u201d directions that conform to the directions established for each ingredient in the directions sections of the applicable OTC drug monographs, unless otherwise stated in this paragraph. When the time intervals or age limitations for administration of the individual ingredients differ, the directions for the combination product may not contain any dosage that exceeds those established for any individual ingredient in the applicable OTC drug monograph(s), and may not provide for use by any age group lower than the highest minimum age limit established for any individual ingredient. For permitted combinations containing a sunscreen and a skin protectant identified in \u00a7 352.20(b), the directions for sunscreens in \u00a7 352.52(d) should be used. For products marketed as a lip protectant or lipstick, \u00a7 352.52(d)(4) applies."], ["21:21:5.0.1.1.27.4.1.1", 21, "Food and Drugs", "I", "D", "352", "PART 352\u2014SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY]", "D", "Subpart D\u2014Testing Procedures", "", "\u00a7 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 \u00b11.279) and the 95-percent confidence interval for the mean SPF must contain the value 4.\n\n(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:\n\nComposition of Preparation A and Preparation B of the Standard Sunscreen\n\n(2) Preparation A and preparation B are heated separately to 77 to 82 \u00b0C, 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 \u00b0C). Add sufficient purified water to obtain 100 grams of standard sunscreen preparation.\n\n(c)  Assay of the standard homosalate sunscreen.  Assay the standard homosalate sunscreen preparation by the following method to ensure proper concentration:\n\n(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.\n\n(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 \u00b0C). Then dilute the solution to volume with the assay solvent and mix well to make a 1-percent solution.\n\n(3)  Preparation of the test solution (1:50 dilution of the 1-percent solution).  Filter a portion of the 1-percent solution through number 1 filter paper. Discard the first 10 to 15 milliliters of the filtrate. Collect the next 20 milliliters of the filtrate (second collection). Add 1 milliliter of the second collection of the filtrate to a 50-milliliter volumetric flask. Dilute this solution to volume with assay solvent and mix well. This is the test solution (1:50 dilution of the 1-percent solution).\n\n(4)  Spectrophotometric determination.  The absorbance of the test solution is measured in a suitable double beam spectrophotometer with the assay solvent and reference beam at a wavelength near 306 nanometers.\n\n(5)  Calculation of the concentration of homosalate.  The concentration of homosalate is determined by the following formula which takes into consideration the absorbance of the sample of the test solution, the dilution of the 1-percent solution (1:50), the weight of the sample of the standard homosalate sunscreen preparation (1 gram), and the standard absorbance value (172) of homosalate as determined by averaging the absorbance of a large number of batches of raw homosalate:\n\nConcentration of homosalate = absorbance \u00d7 50 \u00d7 100 \u00d7 172 = percent concentration by weight."], ["21:21:5.0.1.1.27.4.1.2", 21, "Food and Drugs", "I", "D", "352", "PART 352\u2014SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY]", "D", "Subpart D\u2014Testing Procedures", "", "\u00a7 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\u00b0 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\u2014SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY]", "D", "Subpart D\u2014Testing Procedures", "", "\u00a7 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:\n\nSelection of Fair-skin Subjects \n \n Skin Type and Sunburn and Tanning History (Based on first 30 to 45 minutes sun exposure after a winter season of no sun exposure.) \n \n I\u2014Always burns easily; never tans (sensitive).\n \n II\u2014Always burns easily; tans minimally (sensitive).\n \n III\u2014Burns moderately; tans gradually (light brown) (normal).\n \n IV\u2014Burns minimally; always tans well (moderate brown) (normal).\n \n V\u2014Rarely burns; tans profusely (dark brown) (insensitive).\n \n VI\u2014Never burns; deeply pigmented (insensitive).\n\nSelection of Fair-skin Subjects\n\nSkin Type and Sunburn and Tanning History (Based on first 30 to 45 minutes sun exposure after a winter season of no sun exposure.)\n\nI\u2014Always burns easily; never tans (sensitive).\n\nII\u2014Always burns easily; tans minimally (sensitive).\n\nIII\u2014Burns moderately; tans gradually (light brown) (normal).\n\nIV\u2014Burns minimally; always tans well (moderate brown) (normal).\n\nV\u2014Rarely burns; tans profusely (dark brown) (insensitive).\n\nVI\u2014Never burns; deeply pigmented (insensitive).\n\n(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.\n\n(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.\n\n(c)  Informed consent.  Legally effective written informed consent must be obtained from all individuals.\n\n(d)  Test site delineation \u2014(1)  Test site area.  A test site area serves as an area for determining the subject's MED after application of either the sunscreen standard or the test sunscreen product, or for determining the subject's MED when the skin is unprotected (control site). The area to be tested shall be the back between the beltline and the shoulder blade (scapulae) and lateral to the midline. Each test site area for applying a product or the standard sunscreen shall be a minimum of 50-square centimeters, e.g., 5 \u00d7 10 centimeters. The test site areas are outlined with ink. If the person is to be tested in an upright position, the lines shall be drawn on the skin with the subject upright. If the subject is to be tested while prone, the markings shall be made with the subject prone.\n\n(2)  Test subsite area.  Each test site area shall be divided into at least three test subsite areas that are at least 1 square centimeter. Usually four or five subsites are employed. Each test subsite within a test site area is subjected to a specified dosage of UV radiation, in a series of UV radiation exposures, in which the test site area is exposed for the determination of the MED.\n\n(e)  Application of test materials.  To ensure standardized reporting and to define a product's SPF value, the application of the product shall be expressed on a weight basis per unit area which establishes a standard film. Both the test sunscreen product and the standard sunscreen application shall be 2 milligrams per square centimeter. For oils and most lotions, the viscosity is such that the material can be applied with a volumetric syringe. For creams, heavy gels, and butters, the product shall be warmed slightly so that it can be applied volumetrically. On heating, care shall be taken not to alter the product's physical characteristics, especially separation of the formulations. Pastes and ointments shall be weighed, then applied by spreading on the test site area. A product shall be spread by using a finger cot. If two or more sunscreen drug products are being evaluated at the same time, the test products and the standard sunscreen, as specified in \u00a7 352.70, should be applied in a blinded, randomized manner. If only one sunscreen drug product is being tested, the testing subsites should be exposed to the varying doses of UV radiation in a randomized manner.\n\n(f)  Waiting period.  Before exposing the test site areas after applying a product, a waiting period of at least 15 minutes is required.\n\n(g)  Number of subjects.  A test panel shall consist of not more than 25 subjects with the number fixed in advance by the investigator. From this panel, at least 20 subjects must produce valid data for analysis.\n\n(h)  Response criteria.  In order that the person who evaluates the MED responses does not know which sunscreen formulation was applied to which site or what doses of UV radiation were administered, he/she must not be the same person who applied the sunscreen drug product to the test site or administered the doses of UV radiation. After UV radiation exposure from the solar simulator is completed, all immediate responses shall be recorded. These include several types of typical responses such as the following: An immediate darkening or tanning, typically greyish or purplish in color, fading in 30 to 60 minutes, and attributed to photo-oxidation of existing melanin granules; immediate reddening, fading rapidly, and viewed as a normal response of capillaries and venules to heat, visible and infrared radiation; and an immediate generalized heat response, resembling prickly heat rash, fading in 30 to 60 minutes, and apparently caused by heat and moisture generally irritating to the skin's surface. After the immediate responses are noted, each subject shall shield the exposed area from further UV radiation for the remainder of the test day. The MED is determined 22 to 24 hours after exposure. The erythema responses of the test subject should be evaluated under the following conditions: The source of illumination should be either a tungsten light bulb or a warm white fluorescent light bulb that provides a level of illumination at the test site within the range of 450 to 550 lux, and the test subject should be in the same position used when the test site was irradiated. Testing depends upon determining the smallest dose of energy that produces redness reaching the borders of the exposure site at 22 to 24 hours postexposure for each series of exposures. To determine the MED, somewhat more intense erythemas must also be produced. The goal is to have some exposures that produce absolutely no effect, and of those exposures that produce an effect, the maximal exposure should be no more than twice the total energy of the minimal exposure.\n\n(i)  Rejection of test data.  Test data shall be rejected if the exposure series fails to elicit an MED response on either the treated or unprotected skin sites, or if the responses on the treated sites are randomly absent (which indicates the product was not spread evenly), or if the subject was noncompliant (e.g., subject withdraws from the test due to illness or work conflicts, subject does not shield the exposed testing sites from further UV radiation until the MED is read, etc.)."], ["21:21:5.0.1.1.27.4.1.4", 21, "Food and Drugs", "I", "D", "352", "PART 352\u2014SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY]", "D", "Subpart D\u2014Testing Procedures", "", "\u00a7 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:\n\nV i  (\u03bb) = 1.0 (250 <\u03bb <298 nm)\n\nV i  (\u03bb) = 1.0 0.094 (298 -   l )  (298 <\u03bb <328 nanometers)\n\nV i  (\u03bb) = 1.0 0.015 (139 -   l )  (328 <\u03bb <400 nanometers)\n\n(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:\n\n(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 \u00a7 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 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.\n\n(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 \u00a7 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 (MED(PS)). The doses selected shall consist of a geometric series of five exposures, where the middle exposure is placed to yield the expected SPF plus two other exposures placed symmetrically around the middle exposure. The exact series of exposures to be given to the protected skin shall be determined by the previously established MED(US) and the expected SPF of the test sunscreen. For products with an expected SPF less than 8, the exposures shall be the MED(US) times 0.64X, 0.80X, 0.90X, 1.00X, 1.10X, 1.25X, and 1.56X, where X equals the expected SPF of the test product. For products with an expected SPF between 8 and 15, the exposures shall be the MED(US) times 0.69X, 0.83X, 0.91X, 1.00X, 1.09X, 1.20X, and 1.44X, where X equals the expected SPF of the test product. For products with an expected SPF greater that 15, the exposures shall be the MED(US) times 0.76X, 0.87X, 0.93X, 1.00X, 1.07X, 1.15X, and 1.32X, where X equals the expected SPF of the test product. The MED is the quantity of erythema-effective energy required to produce the first perceptible, unambiguous redness reaction with clearly defined borders at 22 to 24 hours postexposure. The SPF value of the test sunscreen is then calculated from the dose of UV radiation required to produce the MED of the protected skin and from the dose of UV radiation required to produce the MED of the unprotected skin (control site) as follows:\n\nSPF value  = the ratio of erythema effective exposure (Joules per square meter) (MED(PS)) to the erythema effective exposure (Joules per square meter) (MED(US)).\n\n(d)  Determination of the test product's SPF value and PCD.  Use data from at least 20 test subjects with n representing the number of subjects used. First, for each subject, compute the SPF value as stated in \u00a7 352.73(b) and (c). Second, compute the mean SPF value, x\n  , and the standard deviation, s, for these subjects. Third, obtain the upper 5-percent point from the t distribution table with n-1 degrees of freedom. Denote this value by t. Fourth, compute ts/ \u221an. Denote this quantity by A ( i.e. , A  = ts/ \u221an). Fifth, calculate the SPF value to be used in labeling as follows: the label SPF equals the largest whole number less than x\n  . - A. Sixth and last, the drug product is classified into a PCD as follows: if 30 + A <x\n  , the PCD is High; if 12 + A <x\n   <30 + A, the PCD is Moderate; if 2 + A <x\n   <12 + A, the PCD is Minimal; if x\n   <2 + A, the product shall not be labeled as a sunscreen drug product and shall not display an SPF value."], ["21:21:5.0.1.1.27.4.1.5", 21, "Food and Drugs", "I", "D", "352", "PART 352\u2014SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY]", "D", "Subpart D\u2014Testing Procedures", "", "\u00a7 352.76 Determination if a product is water resistant or very water resistant.", "FDA", "", "", "", "The general testing procedures in \u00a7 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 \u00b0C 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.\n\n(a)  Procedure for testing the water resistance of a sunscreen product.  For sunscreen products making the claim of \u201cwater resistant,\u201d 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:\n\n(1) Apply sunscreen product (followed by the waiting period after application of the sunscreen product indicated on the product labeling).\n\n(2) 20 minutes moderate activity in water.\n\n(3) 20-minute rest period (do not towel test sites).\n\n(4) 20 minutes moderate activity in water.\n\n(5) Conclude water test (air dry test sites without toweling).\n\n(6) Begin solar simulator exposure to test site areas as described in \u00a7 352.73.\n\n(b)  Procedure for testing a very water resistant sunscreen product.  For sunscreen products making the claim of \u201cvery water resistant,\u201d 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:\n\n(1) Apply sunscreen product (followed by the waiting period after application of the sunscreen product indicated on the product labeling).\n\n(2) 20 minutes moderate activity in water.\n\n(3) 20-minute rest period (do not towel test sites).\n\n(4) 20 minutes moderate activity in water.\n\n(5) 20-minute rest period (do not towel test sites).\n\n(6) 20 minutes moderate activity in water.\n\n(7) 20-minute rest period (do not towel test sites).\n\n(8) 20 minutes moderate activity in water.\n\n(9) Conclude water test (air dry test sites without toweling).\n\n(10) Begin solar simulator exposure to test site areas as described in \u00a7 352.73."], ["21:21:5.0.1.1.27.4.1.6", 21, "Food and Drugs", "I", "D", "352", "PART 352\u2014SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY]", "D", "Subpart D\u2014Testing Procedures", "", "\u00a7 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 \u00a7 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\u2014COMMERCIAL NUCLEAR POWER PLANTS: EMERGENCY PREPAREDNESS PLANNING", "", "", "", "\u00a7 352.1 Definitions.", "FEMA", "", "", "", "As used in this part, the following terms and concepts are defined:\n\n(a)  Deputy Administrator  means the Deputy Administrator, National Preparedness Directorate, FEMA or designee.\n\n(b)  Administrator  means the Administrator, FEMA or designee.\n\n(c)  EPZ  means Emergency Planning Zone.\n\n(d)  FEMA  means the Federal Emergency Management Agency.\n\n(e)  NRC  means the Nuclear Regulatory Commission.\n\n(f)  Regional Administrator  means the Regional Administrator of FEMA or designee.\n\n(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.\n\n(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.\n\n(i)  Governor  means the Governor of a State or his/her designee.\n\n(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.\n\n(k)  Responsible local official  means the highest elected official of an appropriate local government.\n\n(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.\n\n(m)  Federal facilities and resources  means personnel, property (land, buildings, vehicles, equipment), and operational capabilities controlled by the Federal government related to establishing and maintaining radiological emergency response preparedness.\n\n(n)  Licensee  means the utility which has applied for or has received a license from the NRC to operate a commercial nuclear power plant.\n\n(o)  Reimbursement  means the payment to FEMA/Federal agencies, jointly or severally, by a licensee and State and local governments for assistance and services provided in processing certifications and implementing Federal compensatory assistance under this part 352.\n\n(p)  Host FEMA Regional Office  means the FEMA Regional Office that has primary jurisdiction by virtue of the nuclear power plant being located within its geographic boundaries.\n\n(q)  Command and control  means making and issuing protective action decisions and directing offsite emergency response resources, agencies, and activities."], ["44:44:1.0.1.6.86.0.10.2", 44, "Emergency Management and Assistance", "I", "F", "352", "PART 352\u2014COMMERCIAL NUCLEAR POWER PLANTS: EMERGENCY PREPAREDNESS PLANNING", "", "", "", "\u00a7 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.\n\n(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.\n\n(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\u2014COMMERCIAL NUCLEAR POWER PLANTS: EMERGENCY PREPAREDNESS PLANNING", "A", "Subpart A\u2014Certifications and Determinations", "", "\u00a7 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\u2014COMMERCIAL NUCLEAR POWER PLANTS: EMERGENCY PREPAREDNESS PLANNING", "A", "Subpart A\u2014Certifications and Determinations", "", "\u00a7 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.\n\n(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.\n\n(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\u2014COMMERCIAL NUCLEAR POWER PLANTS: EMERGENCY PREPAREDNESS PLANNING", "A", "Subpart A\u2014Certifications and Determinations", "", "\u00a7 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.\n\n(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.\n\n(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.\n\n(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 \u00a7 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.\n\n(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.\n\n(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 officials.\n\n(g) The times for actions set out above may be extended up to an aggregate of 30 days by the host Regional Administrator or Deputy Administrator for the National Preparedness Directorate, as appropriate."], ["44:44:1.0.1.6.86.1.10.4", 44, "Emergency Management and Assistance", "I", "F", "352", "PART 352\u2014COMMERCIAL NUCLEAR POWER PLANTS: EMERGENCY PREPAREDNESS PLANNING", "A", "Subpart A\u2014Certifications and Determinations", "", "\u00a7 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.\n\n(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.\n\n(c) In making the determination under paragraph (b) of this section, FEMA:\n\n(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\n\n(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.\n\n(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 support, the extent and purpose of the support to be provided, the Federal facilities and resources to be committed and the limitations on their use. The provision of the identified Federal support shall be made under the policies and procedures of subpart B of this part."], ["44:44:1.0.1.6.86.1.10.5", 44, "Emergency Management and Assistance", "I", "F", "352", "PART 352\u2014COMMERCIAL NUCLEAR POWER PLANTS: EMERGENCY PREPAREDNESS PLANNING", "A", "Subpart A\u2014Certifications and Determinations", "", "\u00a7 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\u2014COMMERCIAL NUCLEAR POWER PLANTS: EMERGENCY PREPAREDNESS PLANNING", "B", "Subpart B\u2014Federal Participation", "", "\u00a7 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:\n\n(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));\n\n(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;\n\n(c) Describes the principal response functions which Federal agencies may be called upon to provide;\n\n(d) Describes the process for allocating responsibilities among Federal agencies for planning site-specific emergency response functions; and\n\n(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\u2014COMMERCIAL NUCLEAR POWER PLANTS: EMERGENCY PREPAREDNESS PLANNING", "B", "Subpart B\u2014Federal Participation", "", "\u00a7 352.29 Appeal process.", "FEMA", "", "", "", "(a) Any interested party may appeal a determination made by the Deputy Administrator for the National Preparedness Directorate, under \u00a7\u00a7 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 \u00a7\u00a7 352.5 and 352.6.\n\n(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.\n\n(c) Copies of this determination shall be furnished to the Appellant, the State(s), affected local governments, and the NRC.\n\n(d) For purposes of this section, the term  interested party  means only a licensee, a State or a local government, as defined in \u00a7 352.1(g)."], ["44:44:1.0.1.6.86.2.10.2", 44, "Emergency Management and Assistance", "I", "F", "352", "PART 352\u2014COMMERCIAL NUCLEAR POWER PLANTS: EMERGENCY PREPAREDNESS PLANNING", "B", "Subpart B\u2014Federal Participation", "", "\u00a7 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.\n\n(b) FEMA may call upon the following agencies, and others as needed, to provide Federal technical assistance and Federal facilities and resources:\n\n(1) Department of Commerce;\n\n(2) Department of Defense;\n\n(3) Department of Energy;\n\n(4) Department of Health and Human Services;\n\n(5) Department of Housing and Urban Development;\n\n(6) Department of the Interior;\n\n(7) Department of Transportation;\n\n(8) Environmental Protection Agency;\n\n(9) Federal Communications Commission;\n\n(10) General Services Administration;\n\n(11) National Communications System;\n\n(12) Nuclear Regulatory Commission;\n\n(13) United States Department of Agriculture; and\n\n(14) Department of Veterans Affairs.\n\n(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\u2014COMMERCIAL NUCLEAR POWER PLANTS: EMERGENCY PREPAREDNESS PLANNING", "B", "Subpart B\u2014Federal Participation", "", "\u00a7 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\u2014COMMERCIAL NUCLEAR POWER PLANTS: EMERGENCY PREPAREDNESS PLANNING", "B", "Subpart B\u2014Federal Participation", "", "\u00a7 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.\n\n(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 \u00a7 352.23(a).\n\n(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. \n 1 \n   or approved alternative approaches, and RAC members shall render such technical assistance as appropriate to their agency mission and expertise.\n\n1  Copy available from FEMA Distribution Center, P.O. Box 70274 Washington, DC 20024\n\n(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\u2014COMMERCIAL NUCLEAR POWER PLANTS: EMERGENCY PREPAREDNESS PLANNING", "B", "Subpart B\u2014Federal Participation", "", "\u00a7 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 \u00a7 352.29.\n\n(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.\n\n(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.\n\n(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.\n\n(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\u2014COMMERCIAL NUCLEAR POWER PLANTS: EMERGENCY PREPAREDNESS PLANNING", "B", "Subpart B\u2014Federal Participation", "", "\u00a7 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.\n\n(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.\n\n(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\u2014COMMERCIAL NUCLEAR POWER PLANTS: EMERGENCY PREPAREDNESS PLANNING", "B", "Subpart B\u2014Federal Participation", "", "\u00a7 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:\n\n(a) Arrangements for use of Federal facilities and resources for response functions such as:\n\n(1) Prompt notification of the emergency to the public;\n\n(2) Assisting in any necessary evacuation;\n\n(3) Providing reception centers or shelters and related facilities and services for evacuees;\n\n(4) Providing emergency medical services at Federal hospitals; and\n\n(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.\n\n(b) Arrangements for transferring response functions to State and local governments during the response in an actual emergency; and\n\n(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\u2014COMMERCIAL NUCLEAR POWER PLANTS: EMERGENCY PREPAREDNESS PLANNING", "B", "Subpart B\u2014Federal Participation", "", "\u00a7 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 (\u00a7 352.26), and after complying with E.O. 12657, Section 2(b)(2), which states that FEMA:\n\n(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;\n\n(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;\n\nFEMA 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\u2014COMMERCIAL NUCLEAR POWER PLANTS: EMERGENCY PREPAREDNESS PLANNING", "B", "Subpart B\u2014Federal Participation", "", "\u00a7 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\u2014PLANT QUARANTINE SAFEGUARD REGULATIONS", "", "", "", "\u00a7 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: \u201cSafeguard Regulations.\u201d This title shall be understood to include both the regulations and administrative instructions in this part.\n\n(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:\n\nAdministrative instructions.  Published documents set forth in this part relating to the enforcement of this part, and issued under authority thereof by the Deputy Administrator.\n\nBiological control organism.  Any enemy, antagonist, or competitor used to control a plant pest or noxious weed.\n\nBrought 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.\n\nCarrier; means of conveyance.  Automobile, truck, animal-drawn vehicle, railway car, aircraft, ship, or other means of transportation.\n\nCustoms.  The U.S. Customs Service, Department of the Treasury, or, with reference to Guam, the Customs Office of the Government of Guam.\n\nDeputy 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.\n\nForeign 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 merchandise, as well as domestic merchandise, may be deposited for approved purposes. Movement into and from such area is subject to applicable customs, plant quarantine, and other Federal requirements.\n\nImmediate  ( export, trans-shipment, or transportation and exportation ). The period which, in the opinion of the inspector, is the shortest practicable interval of time between the arrival of an incoming carrier and the departure of the outgoing carrier transporting a consignment of prohibited or restricted products or articles.\n\nInspector.  Any individual authorized by the Administrator of APHIS or the Commissioner of Customs and Border Protection, Department of Homeland Security, to enforce the regulations in this part.\n\nIntended for unloading and entry at a port other than the port of first arrival.  Brought in by carrier at a port for movement to the port of entry under residue cargo procedure of Customs.\n\nNoxious weed.  Any plant or plant product that can directly or indirectly injure or cause damage to crops (including nursery stock or plant products), livestock, poultry, or other interests of agriculture, irrigation, navigation, the natural resources of the United States, the public health, or the environment.\n\nOther product or article.  Any product or article of any character whatsoever (other than plants, plant products, soil, plant pests, and means of conveyance), which an inspector considers may be infested or infected by or contain a plant pest.\n\nOwner.  The owner, or his agent (including the operator of a carrier), having responsible custody of a plant, plant product, plant pest, soil, or other product or article subject to this part.\n\nPerson.  Any individual, partnership, corporation, association, joint venture, society, or other legal entity.\n\nPlant pest.  Any living stage of any of the following that can directly or indirectly injure, cause damage to, or cause disease in any plant or plant product: A protozoan, nonhuman animal, parasitic plant, bacterium, fungus, virus or viroid, infectious agent or other pathogen, or any article similar to or allied with any of the plant pests listed in this definition.\n\nPlant Protection Act.  Title IV of Public Law 106-224, 114 Stat. 438, 7 U.S.C. 7701-7772, which was enacted June 20, 2000.\n\nPlant Protection and Quarantine Programs.  The Plant Protection and Quarantine Programs, Animal and Plant Health Inspection Service, of the U.S. Department of Agriculture.\n\nPlants and plant products.  Nursery stock, other plants, plant parts, roots, bulbs, seeds, fruits, nuts, vegetables, and other plant products, and any product constituted, in whole or in part, of plant material which has not been so manufactured or processed as to eliminate pest risk.\n\nPort.  Any place designated by the President, Secretary of the Treasury, or Congress at which a Customs officer is assigned with authority to accept entries of merchandise, to collect duties, and to enforce the various provisions of the Customs and Navigation laws in force at that place.\n\nPort of arrival.  Any port in the United States at which a prohibited or restricted product or article arrives.\n\nPort of entry.  A port at which a specified shipment or means of conveyance is accepted for entry or admitted without entry into the United States.\n\nResidue cargo.  Shipments authorized by Customs to be transported under the Customs bond of the carrier on which the shipments arrive, without entry being filed, for direct export from the first port of arrival, or to another port for entry or for direct export at that port without entry being required.\n\nSafeguard.  A procedure for handling, maintaining, or disposing of prohibited or restricted products and articles subject to this part so as to eliminate the risk of plant pest dissemination which the prohibited or restricted products and articles may present.\n\nShip.  Any means of transportation by water.\n\nSoil.  The unconsolidated material from the earth's surface that consists of rock and mineral particles and that supports or is capable of supporting biotic communities.\n\nStores and furnishings.  Plants and plant products for use on board a carrier; e.g. as food or decorative material.\n\nUnited States.  The States, the District of Columbia, Guam, Puerto Rico, and the Virgin Islands of the United States, and the territorial waters of the United States adjacent to those land areas.\n\nUnloaded or landed for transportation and exportation.  Brought in by carrier and transferred to another carrier for transportation to another port for exportation, whether or not some form of Customs entry is made.\n\nUnloaded or landed for transshipment and exportation.  Brought in by carrier and transferred to another carrier for exportation from the same port, whether or not some form of Customs entry is made."], ["7:7:5.1.1.1.12.0.47.10", 7, "Agriculture", "III", "", "352", "PART 352\u2014PLANT QUARANTINE SAFEGUARD REGULATIONS", "", "", "", "\u00a7 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 \u00a7 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 \u00a7 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 \n 2 \n   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.\n\n2  The Deputy Administrator, Plant Protection and Quarantine Programs, Animal and Plant Health Inspection Service, U.S. Department of Agriculture, Washington, DC 20250.\n\n(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 may be prescribed in the permits and this part and any others which, in the opinion of the inspector, are necessary and are specified by him to prevent plant pest, noxious weed, or biological control organism dissemination. In the case of prohibited or restricted products or articles subject to this part which are unloaded or landed for transshipment and exportation or transportation and exportation, or for onward movement to the port of entry as residue cargo or under a Customs entry for immediate transportation, this shall include necessary safeguards with respect to any movement within the port area between the point of arrival and the point of temporary storage, other handling, or point of departure, including a foreign trade zone. Prohibited and restricted products and articles subject to this part which are unloaded or landed for transshipment and exportation or transportation and exportation, or for onward movement as residue cargo or under a Customs entry for immediate transportation, shall be transshipped, or transported and exported from the United States, or moved onward immediately. This shall mean the shortest practicable interval of time commensurate with the risk of plant pest, noxious weed, or biological control organism dissemination required to transfer the products or articles from one carrier to another and to move them onward or from the United States. If, in the opinion of the inspector, considerations of risk of plant pest or noxious weed dissemination require, such movement shall be made without regard to the noncompetitive or competitive relations of the carriers concerned, and the inspector shall promptly report to the Plant Protection and Quarantine Programs the circumstances when the emergency is so acute that subsequent movement is required on a carrier of a company other than the one bringing the products or articles to the United States or on which onward movement was contemplated by the shipper or forwarding carrier. Prohibited or restricted plants, plant products, plant pests, biological control organisms, and soil which were intended for entry into the United States under parts 319, 330, or 360 of this chapter, or for movement into or through the United States under this part, and which were refused such entry or movement before unloading or landing, or which were refused such entry or movement after unloading or landing and are immediately reloaded on the same carrier, may be retained on board pending removal from the United States or other disposal, but shall be subject to the safeguards specified under this section. Prohibited or restricted products and articles which were refused entry or movement under said parts after unloading or landing and which are not immediately reloaded in accordance with this section shall be subject to such safeguard action as the inspector deems necessary to carry out the purposes of this part.\n\n(2) Safeguards prescribed by an inspector under this section shall be prescribed to the owner by the inspector in writing except that the inspector may prescribe the safeguards orally when, in his opinion, the circumstances and related Customs procedures do not require written notice to the owner of the safeguards to be followed by the owner. In prescribing safeguards, the relevant requirements of parts 319, 330, or 360 of this chapter and this part shall be considered. The safeguards prescribed shall be the minimum required to preventplant pest, noxious weed, or biological control organism dissemination. Destruction or exportation shall be required only when no less drastic measures are deemed by the inspector to be adequate to prevent plant pest, noxious weed, or biological control organism dissemination. The inspector may follow administrative instructions promulgated for certain situations, or he may follow a procedure selected by him from administratively approved methods known to be effective in similar situations. In the case of aircraft that are contaminated with insect pests, only an insecticidal formulation, approved for use in aircraft, may be so applied as an emergency measure. If the application is not effective against the insect pests or if other pests must be safeguarded against, the inspector shall report the circumstances promptly to the Plant Protection and Quarantine Programs and receive instructions as to safeguards that will not have a deleterious effect on the structure of the aircraft or its operating equipment. In prescribing safeguards consideration will be given to such factors as:\n\n(i) The nature and habits of the plant pests or biological control organisms known to be, or likely to be, present with the plants, plant products, soil, or other products or articles.\n\n(ii) Nature of the plants, plant products, plant pests, or biological control organisms, soil, or other products or articles.\n\n(iii) Nature of containers or other packaging and adequacy thereof to preventplant pest, noxious weed, or biological control organism dissemination.\n\n(iv) Climatic conditions as they may have a bearing on plant pest or biological control organism dispersal, and refrigeration if provided.\n\n(v) Routing pending exportation.\n\n(vi) Presence of soil.\n\n(vii) Construction or physical condition and type of carrier.\n\n(viii) Facilities for treatment in accordance with part 305 of this chapter, or for incineration or other destruction.\n\n(ix) Availability of transportation facilities for immediate exportation.\n\n(x) Any other related factor which should be considered, such as intent to export to an adjacent or nearby country.\n\n(c)  Disposal.  (1) If prohibited or restricted products or articles subject to this part are not safeguarded in accordance with measures prescribed under this part, or cannot be adequately safeguarded to prevent plant pest, noxious weed, or biological control organism dissemination, they shall be seized, destroyed, or otherwise disposed of according to law. Whenever disposal action is to be taken by the inspector he shall notify the local Customs officer in advance.\n\n(2) When a shipment of any products or articles subject to this part has been handled in accordance with all conditions and safeguards prescribed in this part and in the permit and by the inspector, the inspector shall inform the local Customs officer concerned of the release of such products or articles, in appropriate manner."], ["7:7:5.1.1.1.12.0.47.11", 7, "Agriculture", "III", "", "352", "PART 352\u2014PLANT QUARANTINE SAFEGUARD REGULATIONS", "", "", "", "\u00a7 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.\n\n(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.\n\n(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\u2014PLANT QUARANTINE SAFEGUARD REGULATIONS", "", "", "", "\u00a7 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\u2014PLANT QUARANTINE SAFEGUARD REGULATIONS", "", "", "", "\u00a7 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\u2014PLANT QUARANTINE SAFEGUARD REGULATIONS", "", "", "", "\u00a7 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 \u00a7 354.3 of this chapter."], ["7:7:5.1.1.1.12.0.47.15", 7, "Agriculture", "III", "", "352", "PART 352\u2014PLANT QUARANTINE SAFEGUARD REGULATIONS", "", "", "", "\u00a7 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\u2014PLANT QUARANTINE SAFEGUARD REGULATIONS", "", "", "", "\u00a7\u00a7 352.16-352.28 [Reserved]", "APHIS", "", "", "", ""], ["7:7:5.1.1.1.12.0.47.17", 7, "Agriculture", "III", "", "352", "PART 352\u2014PLANT QUARANTINE SAFEGUARD REGULATIONS", "", "", "", "\u00a7 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.\n\n(a)  Permits.  Before moving the avocados through the United States, the owner must obtain a formal permit in accordance with \u00a7 352.6 of this part.\n\n(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.\n\n(c)  Notice of arrival.  At the port of arrival, the owner must provide notification of the arrival of the avocados in accordance with \u00a7 352.7 of this part.\n\n(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.\n\n(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.\n\n(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 extending from Brownsville, Texas, to Galveston, Texas, to Kinder, Louisiana, to Memphis, Tennessee, to Louisville, Kentucky, and due east from Louisville. All cities on these boundary lines are included in this area. If the avocados are moved by air, the aircraft may not land outside this area. Avocados that enter the United States at Nogales, Arizona, must be moved to El Paso, Texas, by the route specified on the formal permit."], ["7:7:5.1.1.1.12.0.47.18", 7, "Agriculture", "III", "", "352", "PART 352\u2014PLANT QUARANTINE SAFEGUARD REGULATIONS", "", "", "", "\u00a7 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.\n\n(a)  Untreated fruit; general \u2014(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 \u00a7 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 \u00a7 352.7.\n\n(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.\n\n(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.\n\n(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 \u00a7 352.10.\n\n(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 denied entry into the United States.\n\n(iii) All refrigerated containers used to transport untreated fruit from Mexico through the United States to a foreign country under this paragraph (a) shall be subject to any treatment in accordance with part 305 of this chapter at the port of first arrival and elsewhere as may be required by the inspector, pursuant to this part, in order to prevent plant pest dissemination.\n\n(b)  Additional conditions for overland movement of certain untreated fruit.  Untreated oranges, tangerines, and grapefruit from Mexico may move overland through the United States to a foreign country only in accordance with the following additional conditions:\n\n(1)  Ports of entry.  Such fruit may enter only at Nogales, AZ, or Eagle Pass, El Paso, or Laredo, TX.\n\n(2)  General transit conditions.  The following conditions apply to all shipments of untreated oranges, tangerines, and grapefruit from Mexico transiting the United States for movement to a foreign country:\n\n(i) The fruit must be packed in insect-proof boxes or crates that prevent the escape or entry of adult, larval, or pupal fruit flies. \n 3\n\n3  If there is a question as to whether packaging is adequate, send a request for approval of the packaging, together with a sample of the packaging, to the Animal and Plant Health Inspection Service, Plant Protection and Quarantine, Center for Plant Health Science and Technology, 1730 Varsity Drive, Suite 400, Raleigh, NC 27606.\n\n(ii) Boxes or cartons of fruit must be enclosed in sealed, refrigerated containers of the type commonly used by the maritime or commercial trucking industry. An official seal must be applied to the container at the port of entry. The seal must not be removed except by an inspector, or after the shipment has left the United States.\n\n(iii) The temperature in the refrigerated containers in which the fruit is transported must be maintained at 60 \u00b0F or lower.\n\n(iv) If the seal on the containers in which such fruit is shipped is found to have been broken, for any reason, before the container leaves the United States, or if the cooling system in the containers fails at any point during transit, an inspector at the port of entry must be contacted immediately.\n\n(v) A transportation and exportation permit must be issued by an inspector for each shipment. This permit can be obtained from APHIS headquarters. \n 4\n\n4  To obtain this permit, contact the Animal and Plant Health Inspection Service, Plant Protection and Quarantine, Permit Unit, 4700 River Road Unit 133, Riverdale, MD 20737.\n\n(vi) If untreated fruit is transloaded to another container while in the United States, the transloading must be supervised by an inspector and a replacement official seal must be applied to the container to which the fruit is moved.\n\n(vii) Shipments of such fruit must move by direct route, in Customs bond and under official seal, without diversion or change of entry en route, from the port of entry to the port of exit or to an approved port in the United States for export to another foreign country.\n\n(viii) Shipments of such fruit may not traverse the counties of Cameron, Hidalgo, Starr, or Willacy, TX. Shipments of such fruit may only traverse areas listed under each type of carrier listed below.\n\n(3)  Truck movement.  Trucks may haul refrigerated containers of such fruit from Mexico to shipside, or to approved refrigerated storage pending lading aboard ship, in Corpus Christi, Galveston, or Houston, TX, or alongside railway carriers or aircraft at the ports named in paragraph (b)(2) of this section for movement to a foreign country. Shipments of such fruit via truck may traverse only the territory within the United States bounded on the west by a line starting at Laredo, TX, on to El Paso, TX, to Salt Lake City, UT, and then to Portland, OR, and on the east by a line drawn from Laredo, TX to Hebbronville, TX, to Corpus Christi, TX, to Galveston, TX, to Kinder, LA, to Memphis, TN, and then to Louisville, KY, and routes directly northward.\n\n(4)  Rail movement.  Shipments must move by direct route from the port of entry to the port of exit or to an approved North Atlantic port in the United States for export to another foreign country, as follows: The fruit may be entered at Nogales, AZ, only for direct rail routing to El Paso, TX, after which it shall traverse only the territory bounded on the west by a line drawn from Laredo, TX, to El Paso, TX, to Salt Lake City, UT, and then to Portland, OR, and on the east by a line drawn from Laredo, TX, to Hebbronville, TX, to Corpus Christi, TX, to Galveston, TX, to Kinder, LA, to Memphis, TN, and then to Louisville, KY, and routes directly northward. Such fruit may also enter the United States from Mexico at any port listed in paragraph (b)(1) of this section, for direct eastward rail movement, without diversion en route, for reentry into Mexico.\n\n(5)  Air cargo movement.  Shipments of such fruit may move by direct route as air cargo, without change of entry while in the United States en route from the port of entry, to Canada. If an emergency occurs en route to the port of export that will require transshipment to another carrier, an inspector at the port of entry must be contacted immediately.\n\n(c)  Additional conditions for movement of certain untreated fruit by water route.  Untreated oranges, tangerines, and grapefruit from Mexico may move from Mexico to a foreign country by water route through the United States under this section only in accordance with the following additional conditions:\n\n(1)  Ports of entry.  Such oranges, tangerines, and grapefruit may enter only at New York, Boston, or such other North Atlantic ports in the United States as may be named in permits, for exportation, or at Galveston, Texas, for exportation by water route.\n\n(2)  Routing through North Atlantic ports.  Such fruit entering via North Atlantic ports in the United States shall move by direct water route to New York or Boston, or to such other North Atlantic ports as may be named in the permit only for immediate direct export by water route to any foreign country, or for immediate transportation and exportation in Customs bond by direct rail route to Canada.\n\n(d)  Restriction on diversion or change of Customs entry.  Diversion or change of Customs entry shall not be permitted with movements authorized under paragraph (b) (4) or (5) or paragraph (c) of this section and the inspector at the original port of Customs entry shall appropriately endorse the Customs documents to show that fact:  Provided,  That the inspector at such port of entry may, when consistent with the purposes of this part, 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 part 319 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 for information as to applicable conditions. If diversion or change of entry is approved at such a port, confirmation will be given by the Plant Protection and Quarantine Programs to appropriate Customs officers and Plant Protection and Quarantine Programs inspectors.\n\n(e)  Untreated fruit from certain municipalities in Mexico.  Oranges, tangerines, and grapefruit in transit to foreign countries may be imported from certain municipalities in Mexico that meet the criteria of \u00a7 319.56-5 for freedom from fruit flies in accordance with the applicable conditions in part 319 of this chapter.\n\n(f)  Treated fruit.  Oranges, tangerines, and grapefruit from Mexico that have been treated in Mexico in accordance with part 305 of this chapter may be moved through the United States ports for exportation in accordance with the regulations in part 319 of this chapter.\n\n(g)  Costs.  Costs shall be borne by the owner of the fruit as provided in \u00a7 352.14. This includes all costs for preinspection and convoying of loaded trucks and supervision of transloading from trucks to approved carriers or storage in United States ports when augmented inspection service has to be provided for such preinspection, convoying, and supervision."], ["7:7:5.1.1.1.12.0.47.2", 7, "Agriculture", "III", "", "352", "PART 352\u2014PLANT QUARANTINE SAFEGUARD REGULATIONS", "", "", "", "\u00a7 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 \u00a7\u00a7 319.8 through 319.8-26 of this chapter. Moreover, the applicable provisions of \u00a7\u00a7 330.100 through 330.109 and 330.400 of this chapter also apply to products and articles subject to this part.\n\n(1) They are brought in temporarily where loading and landing is not intended;\n\n(2) They are unloaded or landed for transshipment and exportation;\n\n(3) They are unloaded or landed for transportation and exportation; or\n\n(4) They are intended for unloading and entry at a port other than the port of arrival.\n\n(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.\n\n(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 sought in accordance with the Customs regulations in 19 CFR chapter I. Prohibited or restricted products and articles that have entered the United States, been exported pursuant to this part, and returned to the United States are subject to the applicable requirements of this part upon reentry.\n\n(2) Any restrictions and requirements under this part with respect to the arrival, temporary stay, unloading, landing, transshipment, exportation, transportation and exportation, or other movement or possession in the United States of any product or article shall apply to any person who, respectively, brings into, maintains, unloads, lands, transships, exports, transports and exports, or otherwise moves or possesses in the United States such product or article, whether he is the person who was required to have a permit for the product or article or a subsequent custodian of such product or article, and failure to comply with all applicable restrictions and requirements under this part by any such person shall be deemed to be a violation of this part.\n\n(d) Under section 436 of the Plant Protection Act (7 U.S.C. 7756), a State or political subdivision of a State may not regulate in foreign commerce any article, means of conveyance, plant, biological control organism, plant pest, noxious weed, or plant product in order to control a plant pest or noxious weed, to eradicate a plant pest or noxious weed, or to prevent the introduction or dissemination of a biological control organism, plant pest, or noxious weed."], ["7:7:5.1.1.1.12.0.47.3", 7, "Agriculture", "III", "", "352", "PART 352\u2014PLANT QUARANTINE SAFEGUARD REGULATIONS", "", "", "", "\u00a7 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.\n\n(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.\n\n(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.\n\n(d) The Deputy Administrator shall employ procedures to carry out the purposes of this part which will impose a minimum of impediment to foreign commerce, consistent with proper precaution against plant pest, noxious weed, or biological control organism dissemination."], ["7:7:5.1.1.1.12.0.47.4", 7, "Agriculture", "III", "", "352", "PART 352\u2014PLANT QUARANTINE SAFEGUARD REGULATIONS", "", "", "", "\u00a7 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.\n\n(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.\n\n(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\u2014PLANT QUARANTINE SAFEGUARD REGULATIONS", "", "", "", "\u00a7 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 \u00a7 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.\n\n(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.\n\n(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 \u00a7 352.10.\n\n(c)  Permit for prohibited or restricted products or articles unloaded or landed for immediate transshipment and exportation, or immediate transportation and exportation.  When in the opinion of the inspector it is unnecessary to specify in a formal permit the safeguards required to prevent plant pest dissemination, plants, plant products, plant pests, biological control organisms, noxious weeds, or soil subject to this part may be unloaded or landed for immediate transshipment and exportation or for immediate transportation and exportation, as provided in \u00a7 352.10, with the approval of the inspector and no further permit than the authorization contained in this paragraph; otherwise a formal permit shall be required for such unloading or landing.\n\n(d)  Permit for restricted products or articles moving as residue cargo from port of first arrival to port of entry.  Restricted plants, plant products, plant pests, biological control organisms, noxious weeds, or soil subject to this part arriving in the United States for movement under residue cargo procedures of Customs from a port of first arrival to another port for Customs entry into the United States may be allowed to so move without permit other than the authorization contained in this paragraph, if the inspector finds that apparently they can meet the applicable requirements of parts 319, 330, and 360 of this chapter at the port where entry is to be made; otherwise a formal permit shall be required for such movement. Such restricted products and articles shall become subject to the applicable permit and other requirements of parts 319, 330, and 360 of this chapter upon arrival at the port where Customs entry is to be made and shall not be unloaded or landed unless they comply with the applicable requirements.\n\n(e)  Formal permits required for certain prohibited or restricted products or articles brought into a foreign trade zone.  A formal permit must be obtained to bring any prohibited or restricted plants, plant products, plant pests, biological control organisms, noxious weeds, or soil subject to the provisions in this part, into a foreign trade zone for storage, manipulation, or other handling, except for immediate transshipment and exportation or for immediate transportation and exportation. Special conditions to safeguard such storage, manipulation, or other possession or handling may be specified in the permit, and when so specified shall be in addition to any other applicable requirements of this part or the safeguards prescribed by the inspector or otherwise under this part."], ["7:7:5.1.1.1.12.0.47.6", 7, "Agriculture", "III", "", "352", "PART 352\u2014PLANT QUARANTINE SAFEGUARD REGULATIONS", "", "", "", "\u00a7 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 \u00a7 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, \n 1 \n   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 \u00a7 352.5 (b), (c), or (d), or in \u00a7 352.11.\n\n1  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.\n\n(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 \u00a7 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 permit in accordance with \u00a7 330.201 of this chapter.\n\n(c)  Soil.  Any person desiring to bring into or unload or land, or otherwise move into or through the United States, any soil for which a specific permit is required by \u00a7 352.5 shall, in advance of the arrival of the soil in the United States, submit an application for permit to the Plant Protection and Quarantine Programs as specified by \u00a7 330.203 of this chapter.\n\n(d)  Constructive oral application.  If a permit has not been issued in advance of arrival, application for any required permit (other than a formal permit) shall be considered to have been made orally to the inspector at the port of arrival by presentation of the shipment for entry or its listing on the manifest or other documentation, but this shall not excuse failure to make timely application as required by this section. Express application is required for a formal permit.\n\n(e)  Approval or denial of permits.  Upon approval of the application, the permit will be issued. Any conditions necessary to eliminate danger of plant pest, noxious weed, or biological control organism dissemination may be specified in the permit, or otherwise as provided in \u00a7 352.10. Permits will be denied if, in the opinion of the Deputy Administrator, it is not possible to prescribe conditions adequate to prevent danger of plant pest, noxious weed, or biological control organism dissemination by the plants, plant products, plant pests, or soil involved."], ["7:7:5.1.1.1.12.0.47.7", 7, "Agriculture", "III", "", "352", "PART 352\u2014PLANT QUARANTINE SAFEGUARD REGULATIONS", "", "", "", "\u00a7 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\u2014PLANT QUARANTINE SAFEGUARD REGULATIONS", "", "", "", "\u00a7 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\u2014PLANT QUARANTINE SAFEGUARD REGULATIONS", "", "", "", "\u00a7 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\u2014EXOTIC ANIMALS; VOLUNTARY INSPECTION", "A", "Subpart A\u2014Exotic Animals", "", "\u00a7 352.1 Definitions.", "FSIS", "", "", "[54 FR 1330, Jan. 13, 1989, as amended at 86 FR 37218, July 15, 2021]", "The definitions in \u00a7 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.\n\n(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. ).\n\n(b)  Acceptable  means suitable for the purpose intended and acceptable to the Food Safety and Inspection Service.\n\n(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.\n\n(d)  Applicant  means any interested party who requests any inspection service.\n\n(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.\n\n(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 ).\n\n(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 ).\n\n(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.\n\n(i)  Condition and wholesomeness  means the condition of any product, its healthfulness and fitness for human food.\n\n(j)  Deer  refers to the any farm-raised species of the family Cervidae.\n\n(k)  Exotic animal  means any reindeer, elk, deer, antelope, water buffalo, bison, buffalo, or yak.\n\n(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.\n\n(m)  Exotic animal inspection service  means the personnel who are engaged in the administration, application, and direction of exotic animal inspection programs and services pursuant to the regulations in this part.\n\n(n)  Exotic animal producer  means any interested party that engages in the raising and/or marketing of an exotic animal for commercial purposes.\n\n(o)  Field ante-mortem inspection  means the ante-mortem inspection of an exotic animal away from the official exotic animal establishment's premises.\n\n(p)  Field designated area  means any designated area on the applicant's premises, approved by the Regional Director, where field ante-mortem inspection is to be performed.\n\n(q)  Identify  means to apply official identification to products or containers.\n\n(r)  Inspection  means any inspection by an inspector to determine, in accordance with regulations in this part, (1) the condition and wholesomeness of an exotic animal, or (2) the condition and wholesomeness of edible product of an exotic animal at any state of the preparation or packaging in the official plant where inspected and certified, or (3) the condition and wholesomeness of any previously inspected and certified product of an exotic animal if such product has not lost its identity as an inspected and certified product.\n\n(s)  Interested party  means any person financially interested in a transaction involving any inspection.\n\n(t)  Official exotic animal establishment  means any slaughtering, cutting, boning, curing, smoking, salting, packing, rendering, or similar establishment at which inspection is maintained under the regulations in this part.\n\n(u)  Official device  means a stamping appliance, branding device, stencil printed label, or any other mechanically or manually operated tool that is approved by the Administrator for the purpose of applying any official mark or other identification to any product or packaging material.\n\n(v)  Official identification  means any symbol, stamp, label or seal indicating that the product has been officially inspected and/or indicating the condition of the product approved and authorized by the Administrator to be affixed to any product, or affixed to or printed on the packaging material of any product.\n\n(w)  Program  means the Voluntary Exotic Animal Inspection Program of the Food Safety and Inspection Service.\n\n(x)  Reindeer  ( Rangifer tarandus ), commonly referred to as caribou, is a species within the family Cervidae with circumpolar distribution, native to Arctic, sub-Arctic, tundra, boreal, and mountainous regions of northern Europe, Siberia, and North America.\n\n(y)  Transport vehicle  means any vehicle used to transport an exotic animal.\n\n(z)  Veterinarian  means an authorized veterinarian of the Program employed by the Department or any cooperating State who is authorized by the Secretary to do any work or perform any duty in connection with the Program.\n\n(aa)  Water buffalo (Bubalus bubalis) , commonly known as the domestic water buffalo or Asian water buffalo, is a large bovid originating in the Indian subcontinent, Southeast Asia, and China.\n\n(bb)  Yak (Bos grunniens)  means a long-haired bovid animal originally found throughout the Himalaya region of southern Central Asia and the Tibetan Plateau."], ["9:9:2.0.2.1.32.1.17.10", 9, "Animals and Animal Products", "III", "A", "352", "PART 352\u2014EXOTIC ANIMALS; VOLUNTARY INSPECTION", "A", "Subpart A\u2014Exotic Animals", "", "\u00a7 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.\n\n(a) To be performed on an exotic animal in the field in a designated area of an exotic animal producer's premises.\n\n(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.\n\n(2) Any person who desires to receive field ante-mortem inspection must provide:\n\n(i) Notification from an official exotic animal establishment to the Regional Director or designee.\n\n(ii) A field ante-mortem designated area.\n\n(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.\n\n(iv) A transport vehicle that is as sanitary as practicable as determined by the inspector.\n\n(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.\n\n(4) An exotic animal that, in the ante-mortem inspector's opinion, does not pass ante-mortem inspection must be withheld from slaughter.\n\n(5) Stunning to render the animal unconscious shall be in accordance with 9 CFR 313.15 or 313.16.\n\n(6) All stunned/slaughtered and bled exotic animals shall be tagged with a \u201cU.S. Suspect\u201d tag in an ear by the ante-mortem inspector or designee prior to loading on the transport vehicle.\n\n(7) The transport of intact exotic animal carcasses to an official exotic animal establishment for post-mortem inspection shall be as expedient as possible, and must be within the same day as field slaughter.\n\n(8) Ante-mortem cards (Form MP 402-2) shall be filled out by the ante-mortem inspector. One copy is to be retained by the ante-mortem inspector. The other copy shall accompany the transport vehicle to the official exotic animal establishment and shall be delivered to the post-mortem veterinarian.\n\n(9) The ante-mortem inspector shall supervise all phases of field ante-mortem inspection.\n\n(b) To be performed on exotic animals that are inside of the transport vehicle at an official exotic animal establishment.\n\n(1) Reindeer, elk, deer, antelope, bison, and water buffalo are eligible for transport vehicle inspection.\n\n(2) The ante-mortem inspector shall remain outside the transport vehicle while performing ante-mortem inspection.\n\n(3) The person requesting transport vehicle inspection must provide a transport vehicle that is as sanitary as practicable and that would safely and thoroughly permit the inspection of an exotic animal from outside of the transport vehicle as determined by the inspector.\n\n(4) The ante-mortem inspector shall determine the adequacy and safety of performing ante-mortem inspection. If, in the ante-mortem inspector's opinion, the transport vehicle is not adequate or safe to perform ante-mortem inspection, the service shall be denied.\n\n(c) To be performed in pens at official exotic animal establishments. The inspection shall be conducted in accordance with the provisions contained in 9 CFR part 309."], ["9:9:2.0.2.1.32.1.17.11", 9, "Animals and Animal Products", "III", "A", "352", "PART 352\u2014EXOTIC ANIMALS; VOLUNTARY INSPECTION", "A", "Subpart A\u2014Exotic Animals", "", "\u00a7 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.\n\n(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.\n\n(c) The post-mortem veterinarian shall inspect and make the disposition of all incoming \u201cU.S. Suspect\u201d tagged exotic animals."], ["9:9:2.0.2.1.32.1.17.12", 9, "Animals and Animal Products", "III", "A", "352", "PART 352\u2014EXOTIC ANIMALS; VOLUNTARY INSPECTION", "A", "Subpart A\u2014Exotic Animals", "", "\u00a7 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\u2014EXOTIC ANIMALS; VOLUNTARY INSPECTION", "A", "Subpart A\u2014Exotic Animals", "", "\u00a7 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\u2014EXOTIC ANIMALS; VOLUNTARY INSPECTION", "A", "Subpart A\u2014Exotic Animals", "", "\u00a7 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\u2014EXOTIC ANIMALS; VOLUNTARY INSPECTION", "A", "Subpart A\u2014Exotic Animals", "", "\u00a7 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\u2014EXOTIC ANIMALS; VOLUNTARY INSPECTION", "A", "Subpart A\u2014Exotic Animals", "", "\u00a7 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\u2014EXOTIC ANIMALS; VOLUNTARY INSPECTION", "A", "Subpart A\u2014Exotic Animals", "", "\u00a7 352.17 Transportation.", "FSIS", "", "", "", "This shall be conducted in accordance with the provisions contained in \u00a7\u00a7 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\u2014EXOTIC ANIMALS; VOLUNTARY INSPECTION", "A", "Subpart A\u2014Exotic Animals", "", "\u00a7 352.18 Cooperation of States in Federal programs.", "FSIS", "", "", "", "Under the \u201cTalmadge-Aiken Act\u201d 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\u2014EXOTIC ANIMALS; VOLUNTARY INSPECTION", "A", "Subpart A\u2014Exotic Animals", "", "\u00a7 352.2 Type of service available.", "FSIS", "", "", "[54 FR 1330, Jan. 13, 1989]", "Upon application, in accordance with \u00a7\u00a7 352.3, 352.4, and 352.5, the following type of service may be furnished under the regulations in this part:\n\n(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.\n\n(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.\n\n(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\u2014EXOTIC ANIMALS; VOLUNTARY INSPECTION", "A", "Subpart A\u2014Exotic Animals", "", "\u00a7 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 \u00a7\u00a7 304.1 and 304.2 of subchapter A of this chapter.\n\n(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\u2014EXOTIC ANIMALS; VOLUNTARY INSPECTION", "A", "Subpart A\u2014Exotic Animals", "", "\u00a7 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.\n\n(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.\n\n(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.\n\n(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\u2014EXOTIC ANIMALS; VOLUNTARY INSPECTION", "A", "Subpart A\u2014Exotic Animals", "", "\u00a7 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.\n\n(b) The fees and charges provided for in this section shall be paid by check, draft, or money order payable to the \u201cTreasurer of the United States\u201d and shall be remitted promptly to the Regional Director upon furnishing to the applicant a statement as to the amount due.\n\n(c) The fees to be charged and collected for service under the regulations in this part shall be at the rates specified in \u00a7\u00a7 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.\n\n(d) Charges may also be made to cover other expenses incurred by the Service in connection with the furnishing of the service.\n\n(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\u2014EXOTIC ANIMALS; VOLUNTARY INSPECTION", "A", "Subpart A\u2014Exotic Animals", "", "\u00a7 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 \u00a7 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 \u00a7 1.147(b) of the rules of practice (7 CFR 1.147(b)).\n\n(b)  For disciplinary reasons \u2014 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 committed any other fraudulent or deceptive practice in connection with any application or request for service under this part; (2) has given or attempted to give, as a loan or for any other purpose, any money, favor or other thing of value, to any employee or agent of the Department or a cooperating State authorized to perform any function under this part; (3) has interfered with or obstructed, or attempted to interfere with or to obstruct, any employee or agent of the Department or cooperating State in the performance of his or her duties under this part by intimidation, threats, assaults, abuse, or any other improper means; (4) has knowingly represented that any exotic animal carcass, or exotic animal product, has been officially inspected and passed by an authorized inspector under this part, when it had not, in fact, been so inspected; (5) has been convicted of more than one misdemeanor under any law based upon the acquiring, handling, or distributing of adulterated, mislabeled, or deceptively packaged good, or fraud in connection with transactions in food, or any felony;  Provided,  an application or a request for service made in the name of a person or entity otherwise eligible for service under the regulations may be denied, or the benefits of the service may be withdrawn, from such a person or entity in case the service is or would be performed at a location operated by a person or entity, from whom the benefits of the service are currently being denied or have been withdrawn under this part; or by a person or entity having an officer, director, partner, manager or substantial investor from whom the benefits of service under this part are currently being denied or have been withdrawn under this part, and who has any authority with respect to the location where service is or would be performed; or in case the service is or would be performed with respect to any exotic animal or exotic animal product in which any person or entity, from whom the benefits of service are currently being denied or have been withdrawn under this part, has contract or other financial interest.\n\n(c)  Procedure.  (1) An application or request for service may be denied or benefits of the service may be withdrawn by the Secretary, as provided by paragraph (b) of this section, after notice and opportunity for hearing before a designated official of the Department. The Administrator may suspend service under this paragraph without hearing, pending final determination of the matter, when he determines that the public health, interest or safety so requires. The applicant or recipient shall be notified of the Administrator's decision to suspend service, and the reasons therefor, in writing or orally. The Administrator's decision to suspend service under this part shall be effective upon such an oral or written notification, whichever is earlier, to the applicant or recipient. If such notification is oral, the Administrator 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 Departmental rules of practice (7 CFR 1.147(b)).\n\n(2) The written notification specified in paragraph (c) of this section, which shall constitute the complaint in the proceeding, shall briefly set forth the reason for the denial or withdrawal of service, including allegations of fact which constitute a basis for the action. After the complaint is served upon the respondent, as provided in \u00a7 1.147(b) of Departmental rules of practice (7 CFR 1.147(b)), the proceeding shall thereafter be conducted in accordance with rules of practice which shall be adopted for the proceeding."], ["9:9:2.0.2.1.32.1.17.7", 9, "Animals and Animal Products", "III", "A", "352", "PART 352\u2014EXOTIC ANIMALS; VOLUNTARY INSPECTION", "A", "Subpart A\u2014Exotic Animals", "", "\u00a7 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.\n\n(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. \n 1 \n   The establishment number of the official establishment shall be set forth if it does not appear on the packaging material or container.\n\n1  The number \u201c38\u201d is given as an example only. The establishment number of the official exotic animal establishment where the product is prepared shall be used in lieu thereof.\n\n(1) For application to exotic animal carcasses, primal parts and cuts therefrom, exotic animal livers, exotic animal tongues, and exotic animal hearts.\n\n(2) For application to exotic animal calf carcasses.\n\n(3) For application to exotic animal tails.\n\n(4) For application to burlap, muslin, cheesecloth, heavy paper, or other acceptable material that encloses carcasses or parts of carcasses.\n\n(b) The official inspection mark to be shown on all labels. \n 1 \n   (1) For inspected and passed products of an exotic animal shall be in the following form, except that it need not be of the size illustrated, provided that it is a sufficient size and of such color as to be conspicuously displayed and readily legible and the same proportions of letter size and boldness are maintained as illustrated:\n\n1  The number \u201c38\u201d is given as an example only. The establishment number of the official exotic animal establishment where the product is prepared shall be used in lieu thereof.\n\n(2) This official mark shall be applied by mechanical means and shall not be applied by a hand stamp.\n\n(3) The official inspection legend described in paragraph (b)(1) of this section shall also be used on shipping containers, bond labels, artificial casings, and other articles with the approval of the Administrator.\n\n(c) Any brand, stamp, label or other device approved by the Administrator and bearing any official mark prescribed in paragraph (a) or (b) of this section shall be an official device for purposes of the Act."], ["9:9:2.0.2.1.32.1.17.8", 9, "Animals and Animal Products", "III", "A", "352", "PART 352\u2014EXOTIC ANIMALS; VOLUNTARY INSPECTION", "A", "Subpart A\u2014Exotic Animals", "", "\u00a7 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\u2014EXOTIC ANIMALS; VOLUNTARY INSPECTION", "A", "Subpart A\u2014Exotic Animals", "", "\u00a7 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. 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