section_id,title_number,title_name,chapter,subchapter,part_number,part_name,subpart,subpart_name,section_number,section_heading,agency,authority,source_citation,amendment_citations,full_text 21:21:5.0.1.1.12.1.1.1,21,Food and Drugs,I,D,331,PART 331—ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE,A,Subpart A—General Provisions,,§ 331.1 Scope.,FDA,,,,An over-the-counter antacid product in a form suitable for oral administration is generally recognized as safe and effective and is not misbranded if it meets each of the following conditions and each of the general conditions established in § 330.1 of this chapter. 21:21:5.0.1.1.12.2.1.1,21,Food and Drugs,I,D,331,PART 331—ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE,B,Subpart B—Active Ingredients,,§ 331.10 Antacid active ingredients.,FDA,,,"[39 FR 19874, June 4, 1974, as amended at 61 FR 4822, Feb. 8, 1996]","(a) The active antacid ingredients of the product consist of one or more of the ingredients permitted in § 331.11 within any maximum daily dosage limit established, each ingredient is included at a level that contributes at least 25 percent of the total acid neutralizing capacity of the product, and the finished product contains at least 5 meq of acid neutralizing capacity as measured by the procedure provided in the United States Pharmacopeia 23/National Formulary 18. The method established in § 331.20 shall be used to determine the percent contribution of each antacid active ingredient. (b) This section does not apply to an antacid ingredient specifically added as a corrective to prevent a laxative or constipating effect." 21:21:5.0.1.1.12.2.1.2,21,Food and Drugs,I,D,331,PART 331—ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE,B,Subpart B—Active Ingredients,,§ 331.11 Listing of specific active ingredients.,FDA,,,"[39 FR 19874, June 4, 1974, as amended at 51 FR 27763, Aug. 1, 1986; 55 FR 19859, May 11, 1990]","(a) Aluminum-containing active ingredients: (1) Basic aluminum carbonate gel. (2) Aluminum hydroxide (or as aluminum hydroxide-hexitol stabilized polymer, aluminum hydroxide-magnesium carbonate codried gel, aluminum hydroxide-magnesium trisilicate codried gel, aluminum-hydroxide sucrose powder hydrated). (3) Dihydroxyaluminum aminoacetate and dihydroxyaluminum aminoacetic acid. (4) Aluminum phosphate gel when used as part of an antacid combination product and contributing at least 25 percent of the total acid neutralizing capacity; maximum daily dosage limit is 8 grams. (5) Dihydroxyaluminum sodium carbonate. (b) Bicarbonate-containing active ingredients: Bicarbonate ion; maximum daily dosage limit 200 mEq. for persons up to 60 years old and 100 mEq. for persons 60 years or older. (c) Bismuth-containing active ingredients: (1) Bismuth aluminate. (2) Bismuth carbonate. (3) Bismuth subcarbonate. (4) Bismuth subgallate. (5) Bismuth subnitrate. (d) Calcium-containing active ingredients: Calcium, as carbonate or phosphate; maximum daily dosage limit 160 mEq. calcium (e.g., 8 grams calcium carbonate). (e) Citrate-containing active ingredients: Citrate ion, as citric acid or salt; maximum daily dosage limit 8 grams. (f) Glycine (aminoacetic acid). (g) Magnesium-containing active ingredients: (1) Hydrate magnesium aluminate activated sulfate. (2) Magaldrate. (3) Magnesium aluminosilicates. (4) Magnesium carbonate. (5) Magnesium glycinate. (6) Magnesium hydroxide. (7) Magnesium oxide. (8) Magnesium trisilicate. (h) Milk solids, dried. (i) Phosphate-containing active ingredients: (1) Aluminum phosphate; maximum daily dosage limit 8 grams. (2) Mono or dibasic calcium salt; maximum daily dosage limit 2 grams. (3) Tricalcium phosphate; maximum daily dosage limit 24 grams. (j) Potassium-containing active ingredients: (1) Potassium bicarbonate (or carbonate when used as a component of an effervescent preparation); maximum daily dosage limit 200 mEq. of bicarbonate ion for persons up to 60 years old and 100 mEq. of bicarbonate ion for persons 60 years or older. (2) Sodium potassium tartrate. (k) Sodium-containing active ingredients: (1) Sodium bicarbonate (or carbonate when used as a component of an effervescent preparation); maximum daily dosage limit 200 mEq. of sodium for persons up to 60 years old and 100 mEq. of sodium for persons 60 years or older, and 200 mEq. of bicarbonate ion for persons up to 60 years old and 100 mEq. of bicarbonate ion for persons 60 years or older. That part of the warning required by § 330.1(g), which states, “Keep this and all drugs out of the reach of children” is not required on a product which contains only sodium bicarbonate powder and which is intended primarily for other than drug uses. (2) Sodium potassium tartrate. (l) Silicates: (1) Magnesium aluminosilicates. (2) Magnesium trisilicate. (m) Tartrate-containing active ingredients. Tartaric acid or its salts; maximum daily dosage limit 200 mEq. (15 grams) of tartrate." 21:21:5.0.1.1.12.2.1.3,21,Food and Drugs,I,D,331,PART 331—ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE,B,Subpart B—Active Ingredients,,§ 331.15 Combination with nonantacid active ingredients.,FDA,,,,"(a) An antacid may contain any generally recognized as safe and effective nonantacid laxative ingredient to correct for constipation caused by the antacid. No labeling claim of the laxative effect may be used for such a product. (b) An antacid may contain any generally recognized as safe and effective analgesic ingredient(s), if it is indicated for use solely for the concurrent symptoms involved, e.g., headache and acid indigestion, and is marketed in a form intended for ingestion as a solution. (c) An antacid may contain any generally recognized as safe and effective antiflatulent ingredient if it is indicated for use solely for the concurrent symptoms of gas associated with heartburn, sour stomach or acid indigestion." 21:21:5.0.1.1.12.3.1.1,21,Food and Drugs,I,D,331,PART 331—ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE,C,Subpart C—Testing Procedures,,§ 331.20 Determination of percent contribution of active ingredients.,FDA,,,"[61 FR 4823, Feb. 8, 1996]","To determine the percent contribution of an antacid active ingredient, place an accurately weighed amount of the antacid active ingredient equal to the amount present in a unit dose of the product into a 250-milliliter (mL) beaker. If wetting is desired, add not more than 5 mL of alcohol (neutralized to an apparent pH of 3.5), and mix to wet the sample thoroughly. Add 70 mL of water, and mix on a magnetic stirrer at 300 ±30 r.p.m. for 1 minute. Analyze the acid neutralizing capacity of the sample according to the procedure provided in the United States Pharmacopeia 23/National Formulary 18 and calculate the percent contribution of the antacid active ingredient in the total product as follows: Percent contribution = (Total mEq. Antacid Active Ingredient × 100)/(Total mEq. Antacid Product)." 21:21:5.0.1.1.12.3.1.2,21,Food and Drugs,I,D,331,PART 331—ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE,C,Subpart C—Testing Procedures,,§ 331.21 Test modifications.,FDA,,,"[61 FR 4823, Feb. 8, 1996]",The formulation or mode of administration of certain products may require a modification of the United States Pharmacopeia 23/National Formulary 18 acid neutralizing capacity test. Any proposed modification and the data to support it shall be submitted as a petition under the rules established in § 10.30 of this chapter. All information submitted will be subject to the disclosure rules in part 20 of this chapter. 21:21:5.0.1.1.12.4.1.1,21,Food and Drugs,I,D,331,PART 331—ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE,D,Subpart D—Labeling,,§ 331.30 Labeling of antacid products.,FDA,,,"[39 FR 19874, June 4, 1974, as amended at 47 FR 38484, Aug. 31, 1982; 51 FR 16266, May 1, 1986; 51 FR 27763, Aug. 1, 1986; 52 FR 7830, Mar. 13, 1987; 55 FR 11581, Mar. 29, 1990; 58 FR 45208, Aug. 26, 1993; 59 FR 60556, Nov. 25, 1994; 61 FR 17806, Apr. 22, 1996; 64 FR 13295, Mar. 17, 1999; 69 FR 13734, Mar. 24, 2004]","(a) Statement of identity. The labeling of the product contains the established name of the drug, if any, and identifies the product as an “antacid.” (b) Indications. The labeling of the product states, under the heading “Indications,” the following: “For the relief of” (optional, any or all of the following:) “heartburn,” “sour stomach,” and/or “acid indigestion” (which may be followed by the optional statement:) “and upset stomach associated with” (optional, as appropriate) “this symptom” or “these symptoms.” Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in this paragraph (b), may also be used, as provided in § 330.1(c)(2) of this chapter, subject to the provisions of section 502 of the act relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act. (c) Warnings. The labeling of the product contains the following warnings, under the heading “Warnings”, which may be combined but not rearranged to eliminate duplicative words or phrases if the resulting warning is clear and understandable: (1) “Do not take more than (maximum recommended daily dosage, broken down by age groups if appropriate, expressed in units such as tablets or teaspoonfuls) in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a physician.” (2) For products which cause constipation in 5 percent or more of persons who take the maximum recommended dosage: “May cause constipation.” (3) For products which cause laxation in 5 percent or more of persons who take the maximum recommended dosage: “May have laxative effect.” (4) For products containing more than 5 gm per day lactose in a maximum daily dosage: “Do not use this product except under advice and supervision of a physician if you are allergic to milk or milk products.” (d) Drug interaction precaution. The labeling of the product contains the following statement “Ask a doctor or pharmacist before use if you are [bullet] 1 presently taking a prescription drug. Antacids may interact with certain prescription drugs.” 1 See § 201.66(b)(4) of this chapter. (e) Directions for use. The labeling of the product contains the recommended dosage, under the heading “Directions”, per time interval (e.g., every 4 hours) or time period (e.g., 4 times a day) broken down by age groups if appropriate, followed by “or as directed by a physician.” (f) Exemption from the general accidental overdose warning. The labeling for antacid drug products containing the active ingredients identified in § 331.11(a), (b), and (d) through (m); permitted combinations of these ingredients provided for in § 331.10; and any of these ingredients or combinations of these ingredients in combination with simethicone (identified in § 332.10 of this chapter and provided for in § 331.15(c)), are exempt from the requirement in § 330.1(g) of this chapter that the labeling bear the general warning statement “In case of accidental overdose, seek professional assistance or contact a poison control center immediately.” With the exception of sodium bicarbonate powder products identified in § 331.11(k)(1), the labeling must continue to bear the first part of the general warning in § 330.1(g) of this chapter, which states, “Keep this and all drugs out of the reach of children.” (g) [Reserved] (h) The word “doctor” may be substituted for the word “physician” in any of the labeling statements in this section." 21:21:5.0.1.1.12.4.1.2,21,Food and Drugs,I,D,331,PART 331—ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE,D,Subpart D—Labeling,,§ 331.80 Professional labeling.,FDA,,,"[39 FR 19874, June 4, 1974. Redesignated and amended at 55 FR 19859, May 11, 1990]","(a) The labeling of the product provided to health professionals (but not to the general public): (1) Shall contain the neutralizing capacity of the product as calculated using the procedure set forth in United States Pharmacopeia 23/National Formulary 18 expressed in terms of the dosage recommended per minimum time interval or, if the labeling recommends more than one dosage, in terms of the minimum dosage recommended per minimum time interval. (2) May contain an indication for the symptomatic relief of hyperacidity associated with the diagnosis of peptic ulcer, gastritis, peptic esophagitis, gastric hyperacidity, and hiatal hernia. (3) For products containing basic aluminum carbonate gel identified in § 331.11(a)(1)—Indication. “For the treatment, control, or management of hyperphosphatemia, or for use with a low phosphate diet to prevent formation of phosphate urinary stones, through the reduction of phosphates in the serum and urine.” (4) For products containing aluminum identified in § 331.11(a) — Warnings. (i) Prolonged use of aluminum-containing antacids in patients with renal failure may result in or worsen dialysis osteomalacia. Elevated tissue aluminum levels contribute to the development of the dialysis encephalopathy and osteomalacia syndromes. Small amounts of aluminum are absorbed from the gastrointestinal tract and renal excretion of aluminum is impaired in renal failure. Aluminum is not well removed by dialysis because it is bound to albumin and transferrin, which do not cross dialysis membranes. As a result, aluminum is deposited in bone, and dialysis osteomalacia may develop when large amounts of aluminum are ingested orally by patients with impaired renal function. (ii) Aluminum forms insoluble complexes with phosphate in the gastrointestinal tract, thus decreasing phosphate absorption. Prolonged use of aluminum-containing antacids by normophosphatemic patients may result in hypophosphatemia if phosphate intake is not adequate. In its more severe forms, hypophosphatemia can lead to anorexia, malaise, muscle weakness, and osteomalacia. (b) Professional labeling for an antacid-antiflatulent combination may contain the information allowed for health professionals for antacids and antiflatulents." 33:33:3.0.1.1.25.0.1.1,33,Navigation and Navigable Waters,II,,331,PART 331—ADMINISTRATIVE APPEAL PROCESS,,,,§ 331.1 Purpose and policy.,USACE,,,,"(a) General. The purpose of this part is to establish policies and procedures to be used for the administrative appeal of approved jurisdictional determinations (JDs), permit applications denied with prejudice, and declined permits. The appeal process will allow the affected party to pursue an administrative appeal of certain Corps of Engineers decisions with which they disagree. The basis for an appeal and the specific policies and procedures of the appeal process are described in the following sections. It shall be the policy of the Corps of Engineers to promote and maintain an administrative appeal process that is independent, objective, fair, prompt, and efficient. (b) Level of decision maker. Appealable actions decided by a division engineer or higher authority may be appealed to an Army official at least one level higher than the decision maker. This higher Army official shall make the decision on the merits of the appeal, and may appoint a qualified individual to act as a review officer (as defined in § 331.2). References to the division engineer in this part shall be understood as also referring to a higher level Army official when such official is conducting an administrative appeal." 33:33:3.0.1.1.25.0.1.10,33,Navigation and Navigable Waters,II,,331,PART 331—ADMINISTRATIVE APPEAL PROCESS,,,,§ 331.10 Final Corps decision.,USACE,,,,"The final Corps decision on a permit application is the initial decision to issue or deny a permit, unless the applicant submits an RFA, and the division engineer accepts the RFA, pursuant to this Part. The final Corps decision on an appealed action is as follows: (a) If the division engineer determines that the appeal is without merit, the final Corps decision is the district engineer's letter advising the applicant that the division engineer has decided that the appeal is without merit, confirming the district engineer's initial decision, and sending the permit denial or the proffered permit for signature to the appellant; or (b) If the division engineer determines that the appeal has merit, the final Corps decision is the district engineer's decision made pursuant to the division engineer's remand of the appealed action. The division engineer will remand the decision to the district engineer with specific instructions to review the administrative record, and to further analyze or evaluate specific issues. If the district engineer determines that the effects of the district engineer's reconsideration of the administrative record would be narrow in scope and impact, the district engineer must provide notification only to those parties who commented or participated in the original review, and would allow 15 days for the submission of supplemental comments. For permit decisions, where the district engineer determines that the effect of the district engineer's reconsideration of the administrative record would be substantial in scope and impact, the district engineer's review process will include issuance of a new public notice, and/or preparation of a supplemental environmental analysis and decision document (see 33 CFR 325.7). Subsequently, the district engineer's decision made pursuant to the division engineer's remand of the appealed action becomes the final Corps permit decision. Nothing in this part precludes the agencies' authorities pursuant to Section 404(q) of the Clean Water Act." 33:33:3.0.1.1.25.0.1.11,33,Navigation and Navigable Waters,II,,331,PART 331—ADMINISTRATIVE APPEAL PROCESS,,,,§ 331.11 Unauthorized activities.,USACE,,,,"Approved JDs, permit denials, and declined permits associated with after-the-fact permit applications are appealable actions for the purposes of this part. If the Corps accepts an after-the-fact permit application, an administrative appeal of an approved JD, permit denial, or declined permit may be filed and processed in accordance with these regulations subject to the provisions of paragraphs (a), (b), and (c) of this section. An appeal of an approved JD associated with unauthorized activities will normally not be accepted unless the Corps accepts an after-the-fact permit application. However, in rare cases, the district engineer may accept an appeal of such an approved JD, if the district engineer determines that the interests of justice, fairness, and administrative efficiency would be served thereby. Furthermore, no such appeal will be accepted if the unauthorized activity is the subject of a referral to the Department of Justice or the EPA, or for which the EPA has the lead enforcement authority or has requested lead enforcement authority. (a) Initial corrective measures. If the district engineer determines that initial corrective measures are necessary pursuant to 33 CFR 326.3(d), an RFA for an appealable action will not be accepted by the Corps, until the initial corrective measures have been completed to the satisfaction of the district engineer. (b) Penalties. If an affected party requests, under this Section, an administrative appeal of an appealable action prior to the resolution of the unauthorized activity, and the division engineer determines that the appeal has no merit, the responsible party remains subject to any civil, criminal, and administrative penalties as provided by law. (c) Tolling of statute of limitations. Any person who appeals an approved JD associated with an unauthorized activity or applies for an after-the-fact permit, where the application is accepted and processed by the Corps, thereby agrees that the statute of limitations regarding any violation associated with that approved JD or application is tolled until one year after the final Corps decision, as defined at § 331.10. Moreover, the recipient of an approved JD associated with an unauthorized activity or applicant for an after-the-fact permit must also memorialize that agreement to toll the statute of limitations, by signing an agreement to that effect, in exchange for the Corps acceptance of the after-the-fact permit application, and/or any administrative appeal (See 33 CFR 326.3(e)(1)(v)). No administrative appeal associated with an unauthorized activity or after-the-fact permit application will be accepted until such signed tolling agreement is furnished to the district engineer." 33:33:3.0.1.1.25.0.1.12,33,Navigation and Navigable Waters,II,,331,PART 331—ADMINISTRATIVE APPEAL PROCESS,,,,§ 331.12 Exhaustion of administrative remedies.,USACE,,,,No affected party may file a legal action in the Federal courts based on a permit denial or a proffered permit until after a final Corps decision has been made and the appellant has exhausted all applicable administrative remedies under this part. The appellant is considered to have exhausted all administrative remedies when a final Corps permit decision is made in accordance with § 331.10. 33:33:3.0.1.1.25.0.1.2,33,Navigation and Navigable Waters,II,,331,PART 331—ADMINISTRATIVE APPEAL PROCESS,,,,§ 331.2 Definitions.,USACE,,,,"The terms and definitions contained in 33 CFR Parts 320 through 330 are applicable to this part. In addition, the following terms are defined for the purposes of this part: Affected party means a permit applicant, landowner, a lease, easement or option holder ( i.e., an individual who has an identifiable and substantial legal interest in the property) who has received an approved JD, permit denial, or has declined a proffered individual permit. Agent(s) means the affected party's business partner, attorney, consultant, engineer, planner, or any individual with legal authority to represent the appellant's interests. Appealable action means an approved JD, a permit denial, or a declined permit, as these terms are defined in this section. Appellant means an affected party who has filed an appeal of an approved JD, a permit denial or declined permit under the criteria and procedures of this part. Approved jurisdictional determination means a Corps document stating the presence or absence of waters of the United States on a parcel or a written statement and map identifying the limits of waters of the United States on a parcel. Approved JDs are clearly designated appealable actions and will include a basis of JD with the document. Basis of jurisdictional determination is a summary of the indicators that support the Corps approved JD. Indicators supporting the Corps approved JD can include, but are not limited to: indicators of wetland hydrology, hydric soils, and hydrophytic plant communities; indicators of ordinary high water marks, high tide lines, or mean high water marks; indicators of adjacency to navigable or interstate waters; indicators that the wetland or waterbody is of part of a tributary system; or indicators of linkages between isolated water bodies and interstate or foreign commerce. Declined permit means a proffered individual permit, including a letter of permission, that an applicant has refused to accept, because he has objections to the terms and special conditions therein. A declined permit can also be an individual permit that the applicant originally accepted, but where such permit was subsequently modified by the district engineer, pursuant to 33 CFR 325.7, in such a manner that the resulting permit contains terms and special conditions that lead the applicant to decline the modified permit, provided that the applicant has not started work in waters of the United States authorized by such permit. Where an applicant declines a permit (either initial or modified), the applicant does not have a valid permit to conduct regulated activities in waters of the United States, and must not begin construction of the work requiring a Corps permit unless and until the applicant receives and accepts a valid Corps permit. Denial determination means a letter from the district engineer detailing the reasons a permit was denied with prejudice. The decision document for the project will be attached to the denial determination in all cases. Jurisdictional determination (JD) means a written Corps determination that a wetland and/or waterbody is subject to regulatory jurisdiction under Section 404 of the Clean Water Act (33 U.S.C. 1344) or a written determination that a waterbody is subject to regulatory jurisdiction under Section 9 or 10 of the Rivers and Harbors Act of 1899 (33 U.S.C. 401 et seq. ). Additionally, the term includes a written reverification of expired JDs and a written reverification of JDs where new information has become available that may affect the previously written determination. For example, such geographic JDs may include, but are not limited to, one or more of the following determinations: the presence or absence of wetlands; the location(s) of the wetland boundary, ordinary high water mark, mean high water mark, and/or high tide line; interstate commerce nexus for isolated waters; and adjacency of wetlands to other waters of the United States. All JDs will be in writing and will be identified as either preliminary or approved. JDs do not include determinations that a particular activity requires a DA permit. Notification of Appeal Process (NAP) means a fact sheet that explains the criteria and procedures of the administrative appeal process. Every approved JD, permit denial, and every proffered individual permit returned for reconsideration after review by the district engineer in accordance with § 331.6(b) will have an NAP form attached. Notification of Applicant Options (NAO) means a fact sheet explaining an applicant's options with a proffered individual permit under the administrative appeal process. Permit denial means a written denial with prejudice (see 33 CFR 320.4(j)) of an individual permit application as defined in 33 CFR 325.5(b). Preliminary JDs are written indications that there may be waters of the United States on a parcel or indications of the approximate location(s) of waters of the United States on a parcel. Preliminary JDs are advisory in nature and may not be appealed. Preliminary JDs include compliance orders that have an implicit JD, but no approved JD. Proffered permit means a permit that is sent to an applicant that is in the proper format for the applicant to sign (for a standard permit) or accept (for a letter of permission). The term “initial proffered permit” as used in this part refers to the first time a permit is sent to the applicant. The initial proffered permit is not an appealable action. However, the applicant may object to the terms or conditions of the initial proffered permit and, if so, a second reconsidered permit will be sent to the applicant. The term “proffered permit” as used in this part refers to the second permit that is sent to the applicant. Such proffered permit is an appealable action. Request for appeal (RFA) means the affected party's official request to initiate the appeal process. The RFA must include the name of the affected party, the Corps file number of the approved JD, denied permit, or declined permit, the reason(s) for the appeal, and any supporting data and information. No new information may be submitted. A grant of right of entry for the Corps to the project site is a condition of the RFA to allow the RO to clarify elements of the record or to conduct field tests or sampling for purposes directly related to the appeal. A standard RFA form will be provided to the affected party with the NAP form. For appeals of decisions related to unauthorized activities a signed tolling agreement, as required by 33 CFR 326.3(e)(1)(v), must be included with the RFA, unless a signed tolling agreement has previously been furnished to the Corps district office. The affected party initiates the administrative appeal process by providing an acceptable RFA to the appropriate Corps of Engineers division office. An acceptable RFA contains all the required information and provides reasons for appeal that meets the criteria identified in § 331.5. Review officer (RO) means the Corps official responsible for assisting the division engineer or higher authority responsible for rendering the final decision on the merits of an appeal. Tolling agreement refers to a document signed by any person who appeals an approved JD associated with an unauthorized activity or applies for an after-the-fact (ATF) permit, where the application is accepted and evaluated by the Corps. The agreement states that the affected party agrees to have the statute of limitations regarding any violation associated with that approved JD or application “tolled” or temporarily set aside until one year after the final Corps decision, as defined at § 331.10. No ATF permit application or administrative appeal associated with an unauthorized activity will be accepted until a tolling agreement is furnished to the district engineer." 33:33:3.0.1.1.25.0.1.3,33,Navigation and Navigable Waters,II,,331,PART 331—ADMINISTRATIVE APPEAL PROCESS,,,,§ 331.3 Review officer.,USACE,,,,"(a) Authority. (1) The division engineer has the authority and responsibility for administering a fair, reasonable, prompt, and effective administrative appeal process. The division engineer may act as the review officer (RO), or may delegate, either generically or on a case-by-case basis, any authority or responsibility described in this part as that of the RO. With the exception of JDs, as described in this paragraph (a)(1), the division engineer may not delegate any authority or responsibility described in this part as that of the division engineer. For approved JDs only, the division engineer may delegate any authority or responsibility described in this part as that of the division engineer, including the final appeal decision. In such cases, any delegated authority must be granted to an official that is at the same or higher grade level than the grade level of the official that signed the approved JD. Regardless of any delegation of authority or responsibility for ROs or for final appeal decisions for approved JDs, the division engineer retains overall responsibility for the administrative appeal process. (2) The RO will assist the division engineer in reaching and documenting the division engineer's decision on the merits of an appeal, if the division engineer has delegated this responsibility as explained in paragraph (a)(1) of this section. The division engineer has the authority to make the final decision on the merits of the appeal. Neither the RO nor the division engineer has the authority to make a final decision to issue or deny any particular permit nor to make an approved JD, pursuant to the administrative appeal process established by this part. The authority to issue or deny permits remains with the district engineer. However, the division engineer may exercise the authority at 33 CFR 325.8(c) to elevate any permit application, and subsequently make the final permit decision. In such a case, any appeal process of the district engineer's initial decision is terminated. If a particular permit application is elevated to the division engineer pursuant to 33 CFR 325.8(c), and the division engineer's decision on the permit application is a permit denial or results in a declined permit, that permit denial or declined permit would be subject to an administrative appeal to the Chief of Engineers. (3) Qualifications. The RO will be a Corps employee with extensive knowledge of the Corps regulatory program. Where the permit decision being appealed was made by the division engineer or higher authority, a Corps official at least one level higher than the decision maker shall make the decision on the merits of the RFA, and this Corps official shall appoint a qualified individual as the RO to conduct the appeal process. (b) General —(1) Independence. The RO will not perform, or have been involved with, the preparation, review, or decision making of the action being appealed. The RO will be independent and impartial in reviewing any appeal, and when assisting the division engineer to make a decision on the merits of the appeal. (2) Review. The RO will conduct an independent review of the administrative record to address the reasons for the appeal cited by the applicant in the RFA. In addition, to the extent that it is practicable and feasible, the RO will also conduct an independent review of the administrative record to verify that the record provides an adequate and reasonable basis supporting the district engineer's decision, that facts or analysis essential to the district engineer's decision have not been omitted from the administrative record, and that all relevant requirements of law, regulations, and officially promulgated Corps policy guidance have been satisfied. Should the RO require expert advice regarding any subject, he may seek such advice from any employee of the Corps or of another Federal or state agency, or from any recognized expert, so long as that person had not been previously involved in the action under review." 33:33:3.0.1.1.25.0.1.4,33,Navigation and Navigable Waters,II,,331,PART 331—ADMINISTRATIVE APPEAL PROCESS,,,,§ 331.4 Notification of appealable actions.,USACE,,,,"Affected parties will be notified in writing of a Corps decision on those activities that are eligible for an appeal. For approved JDs, the notification must include an NAP fact sheet, an RFA form, and a basis of JD. For permit denials, the notification must include a copy of the decision document for the permit application, an NAP fact sheet and an RFA form. For proffered individual permits, when the initial proffered permit is sent to the applicant, the notification must include an NAO fact sheet. For declined permits ( i.e. , proffered individual permits that the applicant refuses to accept and sends back to the Corps), the notification must include an NAP fact sheet and an RFA form. Additionally, an affected party has the right to obtain a copy of the administrative record." 33:33:3.0.1.1.25.0.1.5,33,Navigation and Navigable Waters,II,,331,PART 331—ADMINISTRATIVE APPEAL PROCESS,,,,§ 331.5 Criteria.,USACE,,,,"(a) Criteria for appeal —(1) Submission of RFA. The appellant must submit a completed RFA (as defined at § 331.2) to the appropriate division office in order to appeal an approved JD, a permit denial, or a declined permit. An individual permit that has been signed by the applicant, and subsequently unilaterally modified by the district engineer pursuant to 33 CFR 325.7, may be appealed under this process, provided that the applicant has not started work in waters of the United States authorized by the permit. The RFA must be received by the division engineer within 60 days of the date of the NAP. (2) Reasons for appeal. The reason(s) for requesting an appeal of an approved JD, a permit denial, or a declined permit must be specifically stated in the RFA and must be more than a simple request for appeal because the affected party did not like the approved JD, permit decision, or the permit conditions. Examples of reasons for appeals include, but are not limited to, the following: A procedural error; an incorrect application of law, regulation or officially promulgated policy; omission of material fact; incorrect application of the current regulatory criteria and associated guidance for identifying and delineating wetlands; incorrect application of the Section 404(b)(1) Guidelines (see 40 CFR part 230); or use of incorrect data. The reasons for appealing a permit denial or a declined permit may include jurisdiction issues, whether or not a previous approved JD was appealed. (b) Actions not appealable. An action or decision is not subject to an administrative appeal under this part if it falls into one or more of the following categories: (1) An individual permit decision (including a letter of permission or a standard permit with special conditions), where the permit has been accepted and signed by the permittee. By signing the permit, the applicant waives all rights to appeal the terms and conditions of the permit, unless the authorized work has not started in waters of the United States and that issued permit is subsequently modified by the district engineer pursuant to 33 CFR 325.7; (2) Any site-specific matter that has been the subject of a final decision of the Federal courts; (3) A final Corps decision that has resulted from additional analysis and evaluation, as directed by a final appeal decision; (4) A permit denial without prejudice or a declined permit, where the controlling factor cannot be changed by the Corps decision maker (e.g., the requirements of a binding statute, regulation, state Section 401 water quality certification, state coastal zone management disapproval, etc. (See 33 CFR 320.4(j)); (5) A permit denial case where the applicant has subsequently modified the proposed project, because this would constitute an amended application that would require a new public interest review, rather than an appeal of the existing record and decision; (6) Any request for the appeal of an approved JD, a denied permit, or a declined permit where the RFA has not been received by the division engineer within 60 days of the date of the NAP; (7) A previously approved JD that has been superseded by another approved JD based on new information or data submitted by the applicant. The new approved JD is an appealable action; (8) An approved JD associated with an individual permit where the permit has been accepted and signed by the permittee; (9) A preliminary JD; or (10) A JD associated with unauthorized activities except as provided in § 331.11." 33:33:3.0.1.1.25.0.1.6,33,Navigation and Navigable Waters,II,,331,PART 331—ADMINISTRATIVE APPEAL PROCESS,,,,§ 331.6 Filing an appeal.,USACE,,,,"(a) An affected party appealing an approved JD, permit denial or declined permit must submit an RFA that is received by the division engineer within 60 days of the date of the NAP. Flow charts illustrating the appeal process are in the Appendices of this part. (b) In the case where an applicant objects to an initial proffered individual permit, the appeal process proceeds as follows. To initiate the appeal process regarding the terms and special conditions of the permit, the applicant must write a letter to the district engineer explaining his objections to the permit. The district engineer, upon evaluation of the applicant's objections, may: Modify the permit to address all of the applicant's objections or modify the permit to address some, but not all, of the applicant's objections, or not modify the permit, having determined that the permit should be issued as previously written. In the event that the district engineer agrees to modify the initial proffered individual permit to address all of the applicant's objections, the district engineer will proffer such modified permit to the applicant, enclosing an NAP fact sheet and an RFA form as well. Should the district engineer modify the initial proffered individual permit to address some, but not all, of the applicant's objections, the district engineer will proffer such modified permit to the applicant, enclosing an NAP fact sheet, RFA form, and a copy of the decision document for the project. If the district engineer does not modify the initial proffered individual permit, the district engineer will proffer the unmodified permit to the applicant a second time, enclosing an NAP fact sheet, an RFA form, and a copy of the decision document. If the applicant still has objections, after receiving the second proffered permit (modified or unmodified), the applicant may decline such proffered permit; this declined permit may be appealed to the division engineer upon submittal of a complete RFA form. The completed RFA must be received by the division engineer within 60 days of the NAP. A flow chart of an applicant's options for an initial proffered individual permit is shown in appendix B of this part. A flow chart of the appeal process for a permit denial or a declined permit ( i.e., a proffered permit declined after the Corps decision on the applicant's objections to the initial proffered permit) is shown in appendix A of this part. A flow chart of the appeal process for an approved jurisdictional determination is shown in appendix C of this part. A flow chart of the process for when an unacceptable request for appeal is returned to an applicant is shown in appendix D of this part. (c) An approved JD will be reconsidered by the district engineer if the affected party submits new information or data to the district engineer within 60 days of the date of the NAP. (An RFA that contains new information will either be returned to the district engineer for reconsideration or the appeal will be processed if the applicant withdraws the new information.) The district engineer has 60 days from the receipt of such new information or data to review the new information or data, consider whether or not that information changes the previously approved JD, and, reissue the approved JD or issue a new approved JD. The reconsideration of an approved JD by the district engineer does not commence the administrative appeal process. The affected party may appeal the district engineer's reissued or new approved JD. (d) The district engineer may not delegate his signature authority to deny the permit with prejudice or to return an individual permit to the applicant with unresolved objections. The district engineer may delegate signature authority for JDs, including approved JDs. (e) Affected parties may appeal approved JDs where the determination was dated after March 28, 2000, but may not appeal approved JDs dated on or before March 28, 2000. The Corps will begin processing JD appeals no later than May 30, 2000. All appeals must meet the criteria set forth in § 331.5. If work is authorized by either general or individual permit, and the affected party wishes to request an appeal of the JD associated with the general permit authorization or individual permit or the special conditions of the proffered individual permit, the appeal must be received by the Corps and the appeal process concluded prior to the commencement of any work in waters of the United States and prior to any work that could alter the hydrology of waters of the United States." 33:33:3.0.1.1.25.0.1.7,33,Navigation and Navigable Waters,II,,331,PART 331—ADMINISTRATIVE APPEAL PROCESS,,,,§ 331.7 Review procedures.,USACE,,,,"(a) General. The administrative appeal process for approved JDs, permit denials, and declined permits is a one level appeal, normally to the division engineer. The appeal process will normally be conducted by the RO. The RO will document the appeal process, and assist the division engineer in making a decision on the merits of the appeal. The division engineer may participate in the appeal process as the division engineer deems appropriate. The division engineer will make the decision on the merits of the appeal, and provide any instructions, as appropriate, to the district engineer. (b) Requests for the appeal of approved JDs, permit denials, or declined permits. Upon receipt of an RFA, the RO shall review the RFA to determine whether the RFA is acceptable ( i.e., complete and meets the criteria for appeal). If the RFA is acceptable, the RO will so notify the appellant in writing within 30 days of the receipt of the acceptable RFA. If the RO determines that the RFA is not complete the RO will so notify the appellant in writing within 30 days of the receipt of the RFA detailing the reason(s) why the RFA is not complete. If the RO believes that the RFA does not meet the criteria for appeal (see § 331.5), the RO will make a recommendation on the RFA to the division engineer. If the division engineer determines that the RFA is not acceptable, the division engineer will notify the appellant of this determination by a certified letter detailing the reason(s) why the appeal failed to meet the criteria for appeal. No further administrative appeal is available, unless the appellant revises the RFA to correct the deficiencies noted in the division engineer's letter or the RO's letter. The revised RFA must be received by the division engineer within 30 days of the date of the Corps letter indicating that the initial RFA is not acceptable. If the RO determines that the revised RFA is still not complete, the RO will again so notify the appellant in writing within 30 days of the receipt of the RFA detailing the reason(s) why the RFA is not complete. If the division engineer determines that the revised RFA is still not acceptable, the division engineer will notify the appellant of this determination by a certified letter within 30 days of the date of the receipt of the revised RFA, and will advise the appellant that the matter is not eligible for appeal. No further RFAs will be accepted after this point. (c) Site investigations. Within 30 days of receipt of an acceptable RFA, the RO should determine if a site investigation is needed to clarify the administrative record. The RO should normally conduct any such site investigation within 60 days of receipt of an acceptable RFA. The RO may also conduct a site investigation at the request of the appellant, provided the RO has determined that such an investigation would be of benefit in interpreting the administrative record. The appellant and the appellant's authorized agent(s) must be provided an opportunity to participate in any site investigation, and will be given 15 days notice of any site investigation. The RO will attempt to schedule any site investigation at the earliest practicable time acceptable to both the RO and the appellant. The RO, the appellant, the appellant's agent(s) and the Corps district staff are authorized participants at any site investigation. The RO may also invite any other party the RO has determined to be appropriate, such as any technical experts consulted by the Corps. For permit denials and declined permit appeals, any site investigation should be scheduled in conjunction with the appeal review conference, where practicable. If extenuating circumstances occur at the site that preclude the appellant and/or the RO from conducting any required site visit within 60 days, the RO may extend the time period for review. Examples of extenuating circumstances may include seasonal hydrologic conditions, winter weather, or disturbed site conditions. The site visit must be conducted as soon as practicable as allowed by the extenuating circumstances, however, in no case shall any site visit extend the total appeals process beyond twelve months from the date of receipt of the RFA. If any site visit delay is necessary, the RO will notify the appellant in writing. (d) Approved JD appeal meeting. The RO may schedule an informal meeting moderated by the RO or conference call with the appellant, his authorized agent, or both, and appropriate Corps regulatory personnel to review and discuss issues directly related to the appeal for the purpose of clarifying the administrative record. If a meeting is held, the appellant will bear his own costs associated with necessary arrangements, exhibits, travel, and representatives. The approved JD appeal meeting should be held at a location of reasonable convenience to the appellant and near the site where the approved JD was conducted. (e) Permit denials and declined permits appeal conference. Conferences held in accordance with this part will be informal, and will be chaired by the RO. The purpose of the appeal conference is to provide a forum that allows the participants to discuss freely all relevant issues and material facts associated with the appeal. An appeal conference will be held for every appeal of a permit denial or a declined permit, unless the RO and the appellant mutually agree to forego a conference. The conference will take place within 60 days of receipt of an acceptable RFA, unless the RO determines that unforeseen or unusual circumstances require scheduling the conference for a later date. The purpose of the conference will be to allow the appellant and the Corps district representatives to discuss supporting data and information on issues previously identified in the administrative record, and to allow the RO the opportunity to clarify elements of the administrative record. Presentations by the appellant and the Corps district representatives may include interpretation, clarification, or explanation of the legal, policy, and factual bases for their positions. The conference will be governed by the following guidelines: (1) Notification. The RO will set a date, time, and location for the conference. The RO will notify the appellant and the Corps district office in writing within 30 days of receipt of the RFA, and not less than 15 days before the date of the conference. (2) Facilities. The conference will be held at a location that has suitable facilities and that is reasonably convenient to the appellant, preferably in the proximity of the project site. Public facilities available at no expense are preferred. If a free facility is not available, the Corps will pay the cost for the facility. (3) Participants. The RO, the appellant, the appellant's agent(s) and the Corps district staff are authorized participants in the conference. The RO may also invite any other party the RO has determined to be appropriate, such as any technical experts consulted by the Corps, adjacent property owners or Federal or state agency personnel to clarify elements of the administrative record. The division engineer and/or the district engineer may attend the conference at their discretion. If the appellant or his authorized agent(s) fail to attend the appeal conference, the appeal process is terminated, unless the RO excuses the appellant for a justifiable reason. Furthermore, should the process be terminated in such a manner, the district engineer's original decision on the appealed action will be sustained. (4) The role of the RO. The RO shall be in charge of conducting the conference. The RO shall open the conference with a summary of the policies and procedures for conducting the conference. The RO will conduct a fair and impartial conference, hear and fully consider all relevant issues and facts, and seek clarification of any issues of the administrative record, as needed, to allow the division engineer to make a final determination on the merits of the appeal. The RO will also be responsible for documenting the appeal conference. (5) Appellant rights. The appellant, and/or the appellant's authorized agent(s), will be given a reasonable opportunity to present the appellant's views regarding the subject permit denial or declined permit. (6) Subject matter. The purpose of the appeal conference will be to discuss the reasons for appeal contained in the RFA. Any material in the administrative record may be discussed during the conference, but the discussion should be focused on relevant issues needed to address the reasons for appeal contained in the RFA. The RO may question the appellant or the Corps representatives with respect to interpretation of particular issues in the record, or otherwise to clarify elements of the administrative record. Issues not identified in the administrative record by the date of the NAP for the application may not be raised or discussed, because substantive new information or project modifications would be treated as a new permit application (see § 331.5(b)(5)). (7) Documentation of the appeal conference. The appeal conference is an informal proceeding, intended to provide clarifications and explanations of the administrative record for the RO and the division engineer; it is not intended to supplement the administrative record. Consequently, the proceedings of the conference will not be recorded verbatim by the Corps or any other party attending the conference, and no verbatim transcripts of the conference will be made. However, after the conference, the RO will write a memorandum for the record (MFR) summarizing the presentations made at the conference, and will provide a copy of that MFR to the division engineer, the appellant, and the district engineer. (8) Appellant costs. The appellant will be responsible for his own expenses for attending the appeal conference. (f) Basis of decision and communication with the RO. The appeal of an approved JD, a permit denial, or a declined permit is limited to the information contained in the administrative record by the date of the NAP for the application or approved JD, the proceedings of the appeal conference, and any relevant information gathered by the RO as described in § 331.5. Neither the appellant nor the Corps may present new information not already contained in the administrative record, but both parties may interpret, clarify or explain issues and information contained in the record. (g) Applicability of appeal decisions. Because a decision to determine geographic jurisdiction, deny a permit, or condition a permit depends on the facts, circumstances, and physical conditions particular to the specific project and/or site being evaluated, appeal decisions would be of little or no precedential utility. Therefore, an appeal decision of the division engineer is applicable only to the instant appeal, and has no other precedential effect. Such a decision may not be cited in any other administrative appeal, and may not be used as precedent for the evaluation of any other jurisdictional determination or permit application. While administrative appeal decisions lack precedential value and may not be cited by an appellant or a district engineer in any other appeal proceeding, the Corps goal is to have the Corps regulatory program operate as consistently as possible, particularly with respect to interpretations of law, regulation, an Executive Order, and officially-promulgated policy. Therefore, a copy of each appeal decision will be forwarded to Corps Headquarters; those decisions will be periodically reviewed at the headquarters level for consistency with law, Executive Orders, and policy. Additional official guidance will be issued as necessary to maintain or improve the consistency of the Corps' appellate and permit decisions." 33:33:3.0.1.1.25.0.1.8,33,Navigation and Navigable Waters,II,,331,PART 331—ADMINISTRATIVE APPEAL PROCESS,,,,§ 331.8 Timeframes for final appeal decisions.,USACE,,,,"The Division Engineer will make a final decision on the merits of the appeal at the earliest practicable time, in accordance with the following time limits. The administrative appeal process is initiated by the receipt of an RFA by the division engineer. The Corps will review the RFA to determine whether the RFA is acceptable. The Corps will notify the appellant accordingly within 30 days of the receipt of the RFA in accordance with § 331.7(b). If the Corps determines that the RFA is acceptable, the RO will immediately request the administrative record from the district engineer. The division engineer will normally make a final decision on the merits of the appeal within 90 days of the receipt of an acceptable RFA unless any site visit is delayed pursuant to § 331.7(c). In such case, the RO will complete the appeal review and the division engineer will make a final appeal decision within 30 days of the site visit. In no case will a site visit delay extend the total appeal process beyond twelve months from the date of receipt of an acceptable RFA." 33:33:3.0.1.1.25.0.1.9,33,Navigation and Navigable Waters,II,,331,PART 331—ADMINISTRATIVE APPEAL PROCESS,,,,§ 331.9 Final appeal decision.,USACE,,,,"(a) In accordance with the authorities contained in § 331.3(a), the division engineer will make a decision on the merits of the appeal. While reviewing an appeal and reaching a decision on the merits of an appeal, the division engineer can consult with or seek information from any person, including the district engineer. (b) The division engineer will disapprove the entirety of or any part of the district engineer's decision only if he determines that the decision on some relevant matter was arbitrary, capricious, an abuse of discretion, not supported by substantial evidence in the administrative record, or plainly contrary to a requirement of law, regulation, an Executive Order, or officially promulgated Corps policy guidance. The division engineer will not attempt to substitute his judgment for that of the district engineer regarding a matter of fact, so long as the district engineer's determination was supported by substantial evidence in the administrative record, or regarding any other matter if the district engineer's determination was reasonable and within the zone of discretion delegated to the district engineer by Corps regulations. The division engineer may instruct the district engineer on how to correct any procedural error that was prejudicial to the appellant ( i.e. , that was not a “harmless” procedural error), or to reconsider the decision where any essential part of the district engineer's decision was not supported by accurate or sufficient information, or analysis, in the administrative record. The division engineer will document his decision on the merits of the appeal in writing, and provide a copy of this decision to the applicant (using certified mail) and the district engineer. (c) The final decision of the division engineer on the merits of the appeal will conclude the administrative appeal process, and this decision will be filed in the administrative record for the project." 44:44:1.0.1.6.79.0.10.1,44,Emergency Management and Assistance,I,F,331,PART 331—PRESERVATION OF THE MOBILIZATION BASE THROUGH THE PLACEMENT OF PROCUREMENT AND FACILITIES IN LABOR SURPLUS AREAS,,,,§ 331.1 Purpose.,FEMA,,,,"Success of the national defense program depends upon efficient use of all of our resources, including the labor force and production facilities, which are preserved through utilizing the skills of both management and labor. A primary aim of Federal manpower policy is to encourage full utilization of existing production facilities and workers in preference to creating new plants or moving workers, thus assisting in the maintenance of economic balance and employment stability. When large numbers of new workers move to labor surplus areas, heavy burdens are placed on community facilities, such as schools, hospitals, housing, transportation, and utilities. On the other hand, when unemployment develops in certain areas, unemployment costs increase the total cost to the Government, and plants, tools, and workers' skills remain idle and unable to contribute to our national defense program. Consequently, it is the purpose of Defense Manpower Policy No. 4B to direct attention to the potential of labor surplus areas when awarding appropriate procurement contracts and when locating new plants or facilities." 44:44:1.0.1.6.79.0.10.2,44,Emergency Management and Assistance,I,F,331,PART 331—PRESERVATION OF THE MOBILIZATION BASE THROUGH THE PLACEMENT OF PROCUREMENT AND FACILITIES IN LABOR SURPLUS AREAS,,,,§ 331.2 Policy.,FEMA,,,,"(a) It is the policy of the Federal Government to award appropriate contracts to eligible labor surplus area concerns, to place production facilities in labor surplus areas, and to make the best use of our natural, industrial and labor resources in order to achieve the following objectives: (1) To preserve management and employee skills necessary to the fulfillment of Government contracts and purchases; (2) To maintain productive facilities; (3) To improve utilization of the Nation's total economic potential by making use of the labor force resources of each area; and (4) To help ensure timely delivery of required goods and services and to promote readiness for mobilization by locating procurement where the needed labor force and facilities are fully available. (b) This policy is consonant with the intent of Public Law 95-89 and Public Law 95-507 as implemented by E.O. 12073. In carrying out this policy, Federal departments and agencies shall be guided by E.O. 12073, the policy direction of the Office of Federal Procurement Policy and implementing regulations." 44:44:1.0.1.6.79.0.10.3,44,Emergency Management and Assistance,I,F,331,PART 331—PRESERVATION OF THE MOBILIZATION BASE THROUGH THE PLACEMENT OF PROCUREMENT AND FACILITIES IN LABOR SURPLUS AREAS,,,,§ 331.3 Scope and applicability.,FEMA,,,,"The provisions of this policy apply to all Federal departments and agencies, except as otherwise prohibited by law. In addition to these normal duties; (a) The Secretary of Commerce shall: (1) In cooperation with State economic development agencies, the Secretary of Defense, the Administrator of General Services, and the Administrator of Small Business Administration, assist concerns which have agreed to perform contracts in labor surplus areas in obtaining Government procurement business by providing such concerns with timely information on proposed Government procurements. (2) Urge concerns planning new production facilities to consider the advantages of locating in labor surplus areas. (3) Provide technical advice and counsel to groups and organizations in labor surplus areas on planning industrial parks, industrial development organizations, expanding tourist business, and available Federal aids. (b) The Administrator of the Small Business Administration shall make available to small business concerns in labor surplus areas all of its services, endeavor to ensure opportunity for maximum participation by such concerns in Government procurement, and give consideration to the needs of these concerns in the making of joint small business set-asides with Government procurement agencies. (c) OFPP shall coordinate the maintenance by Federal agencies of current information on the manufacturing capabilities of labor surplus area concerns with respect to Government procurement and disseminate such information to Federal departments and agencies." 44:44:1.0.1.6.79.0.10.4,44,Emergency Management and Assistance,I,F,331,PART 331—PRESERVATION OF THE MOBILIZATION BASE THROUGH THE PLACEMENT OF PROCUREMENT AND FACILITIES IN LABOR SURPLUS AREAS,,,,§ 331.4 Special consideration.,FEMA,,,,"When an entire industry that sells a significant proportion of its production to the Government is generally depressed or has a significant proportion of its production, manufacturing and service facilities located in a labor surplus area, the Administrator, Federal Emergency Management Agency, or successor in function, after notice to and hearing of interested parties, will give consideration to appropriate measures applicable to the entire industry." 44:44:1.0.1.6.79.0.10.5,44,Emergency Management and Assistance,I,F,331,PART 331—PRESERVATION OF THE MOBILIZATION BASE THROUGH THE PLACEMENT OF PROCUREMENT AND FACILITIES IN LABOR SURPLUS AREAS,,,,§ 331.5 Production facilities.,FEMA,,,,"All Federal departments and agencies shall give consideration to labor surplus areas in the selection of sites for Government-financed production facilities, including expansion, to the extent that such selection is consistent with existing law and essential economic and strategic factors." 7:7:5.1.1.1.9.0.47.1,7,Agriculture,III,,331,"PART 331—POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS",,,,§ 331.1 Definitions.,APHIS,,,"[70 FR 13278, Mar. 18, 2005, as amended at 77 FR 61074, Oct. 5, 2012; 79 FR 26830, May 12, 2014; 82 FR 6204, Jan. 19, 2017]","Administrator. The Administrator, Animal and Plant Health Inspection Service, or any person authorized to act for the Administrator. Animal and Plant Health Inspection Service (APHIS). The Animal and Plant Health Inspection Service of the U.S. Department of Agriculture. Attorney General. The Attorney General of the United States or any person authorized to act for the Attorney General. Biological agent. Any microorganism (including, but not limited to, bacteria, viruses, fungi, or protozoa), or infectious substance, or any naturally occurring, bioengineered, or synthesized component of any such microorganism or infectious substance, capable of causing: (1) Death, disease, or other biological malfunction in a human, an animal, a plant, or another living organism; (2) Deterioration of food, water, equipment, supplies, or material of any kind; or (3) Deleterious alteration of the environment. Centers for Disease Control and Prevention (CDC). The Centers for Disease Control and Prevention of the U.S. Department of Health and Human Services. Diagnosis. The analysis of specimens for the purpose of identifying or confirming the presence or characteristics of a select agent or toxin, provided that such analysis is directly related to protecting the public health or safety, animal health or animal products, or plant health or plant products. Entity. Any government agency (Federal, State, or local), academic institution, corporation, company, partnership, society, association, firm, sole proprietorship, or other legal entity. HHS Secretary. The Secretary of the Department of Health and Human Services or his or her designee, unless otherwise specified. HHS select agent and/or toxin. A biological agent or toxin listed in 42 CFR 73.3. Import. To move into, or the act of movement into, the territorial limits of the United States. Information security. Protecting information and information systems from unauthorized access, use, disclosure, disruption, modification, or destruction in order to provide: (1) Integrity, which means guarding against improper information modification or destruction, and includes ensuring information authenticity; (2) Confidentiality, which means preserving authorized restrictions on access and disclosure, including means for protecting personal privacy and proprietary information; and (3) Availability, which means ensuring timely and reliable access to and use of information. Interstate. From one State into or through any other State, or within the District of Columbia, Guam, the Virgin Islands of the United States, or any other territory or possession of the United States. Permit. A written authorization by the Administrator to import or move interstate select agents or toxins, under conditions prescribed by the Administrator. PPQ. The Plant Protection and Quarantine Programs of the Animal and Plant Health Inspection Service. Principal investigator. The one individual who is designated by the entity to direct a project or program and who is responsible to the entity for the scientific and technical direction of that project or program. Recombinant nucleic acids. (1) Molecules that are constructed by joining nucleic acid molecules and that can replicate in a living cell; or (2) Molecules that result from the replication of those described in paragraph (1) of this definition. Responsible official. The individual designated by an entity with the authority and control to ensure compliance with the regulations in this part. Security barrier. A physical structure that is designed to prevent entry by unauthorized persons. Select agent and/or toxin. A biological agent or toxin listed in § 331.3. Specimen. Samples of material from humans, animals, plants, or the environment, or isolates or cultures from such samples, for diagnosis, verification, or proficiency testing. State. Any of the several States of the United States, the Commonwealth of the Northern Mariana Islands, the Commonwealth of Puerto Rico, the District of Columbia, Guam, the Virgin Islands of the United States, or any other territory or possession of the United States. Synthetic nucleic acids. (1) Molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules (i.e., synthetic nucleic acids); or (2) Molecules that result from the replication of those described in paragraph (1) of this definition. Toxin. The toxic material or product of plants, animals, microorganisms (including, but not limited to, bacteria, viruses, fungi, or protozoa), or infectious substances, or a recombinant or synthesized molecule, whatever their origin and method of production, and includes: (1) Any poisonous substance or biological product that may be engineered as a result of biotechnology produced by a living organism; or (2) Any poisonous isomer or biological product, homolog, or derivative of such a substance. United States. All of the States. USDA. The U.S. Department of Agriculture. Validated inactivation procedure. A procedure, whose efficacy is confirmed by data generated from a viability testing protocol, to render a select agent non-viable but allows the select agent to retain characteristics of interest for future use; or to render any nucleic acids that can produce infectious forms of any select agent virus non-infectious for future use. Verification. The demonstration of obtaining established performance ( e.g. , accuracy, precision, and the analytical sensitivity and specificity) specifications for any procedure used for diagnosis. Viability testing protocol. A protocol to confirm the validated inactivation procedure by demonstrating the material is free of all viable select agent." 7:7:5.1.1.1.9.0.47.10,7,Agriculture,III,,331,"PART 331—POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS",,,,§ 331.10 Restricting access to select agents and toxins; security risk assessments.,APHIS,,,"[70 FR 13278, Mar. 18, 2005, as amended at 77 FR 61075, Oct. 5, 2012; 82 FR 6205, Jan. 19, 2017]","(a) An individual or entity required to register under this part may not provide an individual access to a select agent or toxin, and an individual may not access a select agent or toxin, unless the individual is approved by the Administrator or the HHS Secretary following a security risk assessment by the Attorney General. (b) An individual will be deemed to have access at any point in time if the individual has possession of a select agent or toxin ( e.g. , carries, uses, or manipulates) or the ability to gain possession of a select agent or toxin. (c) Each individual with access to select agents or toxins must have the appropriate education, training, and/or experience to handle or use such agents or toxins. (d) To apply for access approval, each individual must submit the information necessary to conduct a security risk assessment to the Attorney General. (e) A person with valid approval from the HHS Secretary or Administrator to have access to select agents or toxins may request, through his or her Responsible Official, that the HHS Secretary or Administrator provide their approved access status to another registered individual or entity for a specified period of time. A responsible official must immediately notify the responsible official of the visiting entity if the person's access to select agents or toxins has been terminated. (f) An individual's security risk assessment may be expedited upon written request by the responsible official and a showing of good cause ( e.g. , agricultural emergencies, national security, or a short-term visit by a prominent researcher). A written decision granting or denying the request will be issued. (g) An individual's access approval may be denied, limited, or revoked if: (1) The individual is within any of the categories described in 18 U.S.C. 175b; (2) The individual is reasonably suspected by any Federal law enforcement or intelligence agency of committing a crime set forth in 18 U.S.C. 2332b(g)(5); knowing involvement with an organization that engages in domestic or international terrorism (as defined in 18 U.S.C. 2331) or with any other organization that engages in intentional crimes of violence; or being an agent of a foreign power as defined in 50 U.S.C. 1801; or (3) It is determined that such action is necessary to protect plant health or plant products. (h) An individual may appeal the Administrator's decision to deny, limit, or revoke access approval under § 331.20. (i) Access approval is valid for a maximum of 3 years. (j) The responsible official must immediately notify APHIS or CDC when an individual's access to select agents or toxins is terminated by the entity and the reasons therefore." 7:7:5.1.1.1.9.0.47.11,7,Agriculture,III,,331,"PART 331—POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS",,,,§ 331.11 Security.,APHIS,,,"[70 FR 13278, Mar. 18, 2005, as amended at 77 FR 61075, Oct. 5, 2012; 79 FR 26830, May 12, 2014; 82 FR 6205, Jan. 19, 2017; 83 FR 48202, Sept. 24, 2018]","(a) An individual or entity required to register under this part must develop and implement a written security plan. The security plan must be sufficient to safeguard the select agent or toxin against unauthorized access, theft, loss, or release. (b) The security plan must be designed according to a site-specific risk assessment and must provide graded protection in accordance with the risk of the select agent or toxin, given its intended use. A current security plan must be submitted for initial registration, renewal of registration, or when requested. (c) The security plan must: (1) Describe procedures for physical security, inventory control, and information systems control; (2) Contain provisions for the control of access to select agents and toxins, including the safeguarding of animals (including arthropods) or plants intentionally or accidentally exposed to or infected with a select agent, against unauthorized access, theft, loss or release. (3) Contain provisions for routine cleaning, maintenance, and repairs; (4) Establish procedures for removing unauthorized or suspicious persons; (5) Describe procedures for addressing loss or compromise of keys, keycards, passwords, combinations, etc. and protocols for changing access permissions or locks following staff changes; (6) Contain procedures for reporting unauthorized or suspicious persons or activities, loss or theft of select agents or toxins, release of select agents or toxins, or alteration of inventory records; (7) Contain provisions for ensuring that all individuals with access approval from the Administrator or the HHS Secretary understand and comply with the security procedures; (8) Describe procedures for how the Responsible Official will be informed of suspicious activity that may be criminal in nature and related to the entity, its personnel, or its select agents or toxins; and describe procedures for how the entity will notify the appropriate Federal, State, or local law enforcement agencies of such activity. (9) Contain provisions for information security that: (i) Ensure that all external connections to systems which manage security for the registered space are isolated or have controls that permit only authorized and authenticated users; (ii) Ensure that authorized and authenticated users are only granted access to select agent and toxin related information, files, equipment (e.g., servers or mass storage devices), and applications as necessary to fulfill their roles and responsibilities, and that access is modified when the user's roles and responsibilities change or when their access to select agents and toxins is suspended or revoked; (iii) Ensure that controls are in place that are designed to prevent malicious code (such as, but not limited to, computer viruses, worms, spyware) from compromising the confidentiality, integrity, or availability of information systems which manage access to spaces registered under this part or records as specified in § 331.17; (iv) Establish a robust configuration management practice for information systems to include regular patching and updates made to operating systems and individual applications; and (v) Establish procedures that provide backup security measures in the event that access control systems, surveillance devices, and/or systems that manage the requirements of § 331.17 are rendered inoperable. (10) Contain provisions and policies for shipping, receiving, and storage of select agents and toxins, including documented procedures for receiving, monitoring, and shipping of all select agents and toxins. These provisions must provide that an entity will properly secure containers on site and have a written contingency plan for unexpected shipments. (d) An individual or entity must adhere to the following security requirements or implement measures to achieve an equivalent or greater level of security: (1) Allow access only to individuals with access approval from the Administrator or the HHS Secretary; (2) Allow individuals not approved for access by the Administrator or the HHS Secretary to conduct routine cleaning, maintenance, repairs, and other activities not related to select agents or toxins only when continuously escorted by an approved individual if the potential to access to select agents or toxins exists; (3) Provide for the control of select agents and toxins by requiring freezers, refrigerators, cabinets, and other containers where select agents or toxins are stored to be secured against unauthorized access ( e.g. , card access system, lock boxes); (4) Inspect all suspicious packages before they are brought into or removed from an area where select agents or toxins are used or stored; (5) Establish a protocol for intra-entity transfers under the supervision of an individual with access approval from the Administrator or the HHS Secretary, including chain-of-custody documents and provisions for safeguarding against theft, loss, or release; and (6) Require that individuals with access approval from the Administrator or the HHS Secretary refrain from sharing with any other person their unique means of accessing a select agent or toxin ( e.g. , keycards or passwords); (7) Require that individuals with access approval from the Administrator or the HHS Secretary immediately report any of the following to the responsible official: (i) Any loss or compromise of keys, passwords, combinations, etc.; (ii) Any suspicious persons or activities; (iii) Any loss or theft of select agents or toxins; (iv) Any release of a select agent or toxin; (v) Any sign that inventory or use records for select agents or toxins have been altered or otherwise compromised; and (vi) Any loss of computer, hard drive or other data storage device containing information that can be used to gain access to select agents or toxins; and (8) Separate areas where select agents and toxins are stored or used from the public areas of the building. (e) Entities must conduct complete inventory audits of all affected select agents and toxins in long-term storage when any of the following occur: (1) Upon the physical relocation of a collection or inventory of select agents or toxins for those select agents or toxins in the collection or inventory; (2) Upon the departure or arrival of a principal investigator for those select agents and toxins under the control of that principal investigator; or (3) In the event of a theft or loss of a select agent or toxin, all select agents and toxins under the control of that principal investigator. (f) [Reserved] (g) In developing a security plan, an individual or entity should consider the document entitled, “ Security Plan Guidance.” This document is available on the National Select Agent Registry at http://www.selectagents.gov/. (h) The plan must be reviewed annually and revised as necessary. Drills or exercises must be conducted at least annually to test and evaluate the effectiveness of the plan. The plan must be reviewed and revised, as necessary, after any drill or exercise and after any incident. Drills or exercises must be documented to include how the drill or exercise tested and evaluated the plan, any problems that were identified and corrective action(s) taken, and the names of registered entity personnel participants." 7:7:5.1.1.1.9.0.47.12,7,Agriculture,III,,331,"PART 331—POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS",,,,§ 331.12 Biocontainment.,APHIS,,,"[70 FR 13278, Mar. 18, 2005, as amended at 77 FR 61076, Oct. 5, 2012; 79 FR 26830, May 12, 2014; 82 FR 6205, Jan. 19, 2017]","(a) An individual or entity required to register under this part must develop and implement a written biocontainment plan that is commensurate with the risk of the select agent or toxin, given its intended use. 4 The biocontainment plan must contain sufficient information and documentation to describe the biocontainment procedures for the select agent or toxin, including any animals (including arthropods) or plants intentionally or accidentally exposed to or infected with a select agent. The current biocontainment plan must be submitted for initial registration, renewal of registration, or when requested. The biocontainment plan must include the following provisions: 4 Technical assistance and guidance may be obtained by contacting APHIS. (1) The hazardous characteristics of each agent or toxin listed on the entity's registration and the biocontainment risk associated with laboratory procedures related to the select agent or toxin; (2) Safeguards in place with associated work practices to protect entity personnel, the public, and the environment from exposure to the select agent or toxin including, but not limited to: Personal protective equipment and other safety equipment; containment equipment including, but not limited to, biological safety cabinets, animal caging systems, and centrifuge safety containers; and engineering controls and other facility safeguards; (3) Written procedures for each validated method used for disinfection, decontamination, or destruction, as appropriate, of all contaminated or presumptively contaminated materials including, but not limited to: Cultures and other materials related to the propagation of select agents or toxins, items related to the analysis of select agents and toxins, personal protective equipment, arthropod containment systems, extracted plant and/or arthropod tissues, laboratory surfaces and equipment, and effluent material; and (4) Procedures for the handling of select agents and toxins in the same spaces with non-select agents and toxins to prevent unintentional contamination. (b) The biocontainment procedures must be sufficient to contain the select agent or toxin ( e.g. , physical structure and features of the entity, and operational and procedural safeguards). (c) In developing a biocontainment plan, an individual or entity should consider the following: (1) “Containment Facilities and Safeguards for Exotic Plant Pathogens and Pests” (Robert P. Kahn and S.B. Mathur eds., 1999); and (2) “A Practical Guide to Containment: Greenhouse Research with Transgenic Plants and Microbes” (Patricia L. Traynor ed., 2001). (d) [Reserved] (e) The plan must be reviewed annually and revised as necessary. Drills or exercises must be conducted at least annually to test and evaluate the effectiveness of the plan. The plan must be reviewed and revised, as necessary, after any drill or exercise and after any incident. Drills or exercises must be documented to include how the drill or exercise tested and evaluated the plan, any problems that were identified and corrective action(s) taken, and the names of registered entity personnel participants." 7:7:5.1.1.1.9.0.47.13,7,Agriculture,III,,331,"PART 331—POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS",,,,§ 331.13 Restricted experiments.,APHIS,,,"[70 FR 13278, Mar. 18, 2005, as amended at 77 FR 61076, Oct. 5, 2012; 79 FR 26830, May 12, 2014]","(a) An individual or entity may not conduct or possess products resulting from the following experiments unless approved by and conducted in accordance with the conditions prescribed by the Administrator: (1) Experiments that involve the deliberate transfer of, or selection for, a drug or chemical resistance trait to select agents that are not known to acquire the trait naturally, if such acquisition could compromise the control of disease agents in humans, veterinary medicine, or agriculture. (2) Experiments involving the deliberate formation of synthetic or recombinant nucleic acids containing genes for the biosynthesis of select toxins lethal for vertebrates at an LD[50]<100 ng/kg body weight. (b) The Administrator may revoke approval to conduct any of the experiments in paragraph (a) of this section, or revoke or suspend a certificate of registration, if the individual or entity fails to comply with the requirements of this part. (c) To apply for approval to conduct any of the experiments in paragraph (a) of this section, an individual or entity must submit a written request and supporting scientific information to the Administrator. A written decision granting or denying the request will be issued." 7:7:5.1.1.1.9.0.47.14,7,Agriculture,III,,331,"PART 331—POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS",,,,§ 331.14 Incident response.,APHIS,,,"[70 FR 13278, Mar. 18, 2005, as amended at 77 FR 61076, Oct. 5, 2012; 82 FR 6206, Jan. 19, 2017]","5 Nothing in this section is meant to supersede or preempt incident response requirements imposed by other statutes or regulations. (a) An individual or entity required to register under this part must develop and implement a written incident response plan 6 based upon a site specific risk assessment. The incident response plan must be coordinated with any entity-wide plans, kept in the workplace, and available to employees for review. The current incident response plan must be submitted for initial registration, renewal of registration, or when requested. 6 Technical assistance and guidance may be obtained by contacting APHIS. (b) The incident response plan must fully describe the entity's response procedures for the theft, loss, or release of a select agent or toxin; inventory discrepancies; security breaches (including information systems); severe weather and other natural disasters; workplace violence; bomb threats and suspicious packages; and emergencies such as fire, gas leak, explosion, power outage, and other natural and man-made events. (c) The response procedures must account for hazards associated with the select agent or toxin and appropriate actions to contain such select agent or toxin, including any animals (including arthropods) or plants intentionally or accidentally exposed to or infected with a select agent. (d) The incident response plan must also contain the following information: (1) The name and contact information ( e.g. , home and work) for the individual or entity ( e.g. , responsible official, alternate responsible official(s), biosafety officer, etc.); (2) The name and contact information for the building owner and/or manager, where applicable; (3) The name and contact information for tenant offices, where applicable; (4) The name and contact information for the physical security official for the building, where applicable; (5) Personnel roles and lines of authority and communication; (6) Planning and coordination with local emergency responders; (7) Procedures to be followed by employees performing rescue or medical duties; (8) Emergency medical treatment and first aid; (9) A list of personal protective and emergency equipment, and their locations; (10) Site security and control; (11) Procedures for emergency evacuation, including type of evacuation, exit route assignments, safe distances, and places of refuge; and (12) Decontamination procedures. (e) [Reserved] (f) The plan must be reviewed annually and revised as necessary. Drills or exercises must be conducted at least annually to test and evaluate the effectiveness of the plan. The plan must be reviewed and revised, as necessary, after any drill or exercise and after any incident. Drills or exercises must be documented to include how the drill or exercise tested and evaluated the plan, any problems that were identified and corrective action(s) taken, and the names of registered entity personnel participants." 7:7:5.1.1.1.9.0.47.15,7,Agriculture,III,,331,"PART 331—POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS",,,,§ 331.15 Training.,APHIS,,,"[77 FR 61076, Oct. 5, 2012, as amended at 82 FR 6206, Jan. 19, 2017]","(a) An individual or entity required to register under this part must provide information and training on biocontainment, biosafety, security (including security awareness), and incident response to: (1) Each individual with access approval from the Administrator or HHS Secretary. The training must address the particular needs of the individual, the work they will do, and the risks posed by the select agents or toxins. The training must be accomplished prior to the individual's entry into an area where a select agent is handled or stored, or within 12 months of the date the individual was approved by the Administrator or the HHS Secretary for access, whichever is earlier. (2) Each individual not approved for access to select agents and toxins by the Administrator or HHS Secretary before that individual enters areas under escort where select agents or toxins are handled or stored ( e.g., laboratories, growth chambers, animal rooms, greenhouses, storage areas, shipping/receiving areas, production facilities, etc.). Training for escorted personnel must be based on the risk associated with accessing areas where select agents and toxins are used and/or stored. The training must be accomplished prior to the individual's entry into where select agents or toxins are handled or stored ( e.g., laboratories, growth chambers, animal rooms, greenhouses, storage areas, shipping/receiving areas, production facilities, etc.). (b) [Reserved] (c) Refresher training must be provided annually for individuals with access approval from the HHS Secretary or Administrator or at such time as the registered individual or entity significantly amends its security, incident response, or biocontainment plans. (d) The responsible official must ensure a record of the training provided to each individual with access to select agents and toxins and each escorted individual (e.g., laboratory workers, visitors, etc.) is maintained. The record must include the name of the individual, the date of the training, a description of the training provided, and the means used to verify that the employee understood the training. (e) The responsible official must ensure and document that individuals are provided the contact information of the USDA Office of Inspector General Hotline and the HHS Office of Inspector General Hotline so that they may anonymously report any safety or security concerns related to select agents and toxins." 7:7:5.1.1.1.9.0.47.16,7,Agriculture,III,,331,"PART 331—POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS",,,,§ 331.16 Transfers.,APHIS,,,"[70 FR 13278, Mar. 18, 2005, as amended at 77 FR 61077, Oct. 5, 2012; 82 FR 6206, Jan. 19, 2017]","(a) Except as provided in paragraph (c) of this section, a select agent or toxin may only be transferred to an individual or entity registered to possess, use, or transfer that agent or toxin. A select agent or toxin may only be transferred under the conditions of this section and must be authorized by APHIS or CDC prior to the transfer. 7 7 The requirements of this section do not apply to transfers within a registered entity ( i.e. , the sender and the recipient are covered by the same certificate of registration). (b) A transfer may be authorized if: (1) The sender: (i) Has at the time of transfer a certificate of registration that covers the particular select agent or toxin to be transferred and meets all the requirements of this part; (ii) Meets the exemption requirements for the particular select agent or toxin to be transferred; or (iii) Is transferring the select agent or toxin from outside of the United States and meets all import requirements. (2) At the time of transfer, the recipient has a certificate of registration that includes the particular select agent or toxin to be transferred and meets all of the requirements of this part. (c) On a case-by-case basis, the Administrator may authorize a transfer of a select agent or toxin not otherwise eligible for transfer under this part under conditions prescribed by the Administrator. (d) To obtain authorization for a transfer, APHIS/CDC Form 2 must be submitted. (e) After authorization is provided by APHIS or CDC, the packaging of the select agent(s) and toxin(s) is performed by an individual approved by the HHS Secretary or Administrator to have access to select agents and toxins and is in compliance with all applicable laws concerning packaging. (f) The sender must comply with all applicable laws governing shipping. (g) Transportation in commerce starts when the select agent(s) or toxin(s) are packaged for shipment and ready for receipt by a courier transporting select agent(s) or toxin(s) and ends when the package is received by the intended recipient who is an individual approved by the HHS Secretary or Administrator to have access to select agents and toxins, following a security risk assessment by the Attorney General. (h) The recipient must submit a completed APHIS/CDC Form 2 within 2 business days of receipt of a select agent or toxin. (i) The recipient must immediately notify APHIS or CDC if the select agent or toxin has not been received within 48 hours after the expected delivery time or if the package containing the select agent or toxin has been damaged to the extent that a release of the select agent or toxin may have occurred. (j) An authorization for a transfer shall be valid only for 30 calendar days after issuance, except that such an authorization becomes immediately null and void if any facts supporting the authorization change ( e.g. , change in the certificate of registration for the sender or recipient, change in the application for transfer)." 7:7:5.1.1.1.9.0.47.17,7,Agriculture,III,,331,"PART 331—POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS",,,,§ 331.17 Records.,APHIS,,,"[70 FR 13278, Mar. 18, 2005, as amended at 77 FR 61077, Oct. 5, 2012; 82 FR 6206, Jan. 19, 2017]","(a) An individual or entity required to register under this part must maintain complete records relating to the activities covered by this part. Such records must include: (1) An accurate, current inventory for each select agent (including viral genetic elements, recombinant and/or synthetic nucleic acids, and organisms containing recombinant and/or synthetic nucleic acids) held in long-term storage (placement in a system designed to ensure viability for future use, such as in a freezer or lyophilized materials), including: (i) The name and characteristics ( e.g. , strain designation, GenBank Accession number, etc.); (ii) The quantity acquired from another individual or entity ( e.g. , containers, vials, tubes, etc.), date of acquisition, and the source; (iii) Where stored ( e.g. , building, room, and freezer or other storage container); (iv) When moved from storage and by whom and when returned to storage and by whom; (v) The select agent used, purpose of use, and, when applicable, final disposition; (vi) Records created under § 331.16 (Transfers); (vii) For intra-entity transfers (sender and the recipient are covered by the same certificate of registration), the select agent, the quantity transferred, the date of transfer, the sender, and the recipient; and (viii) Records created under § 331.19 (Notification of theft, loss, or release); (2) An accurate, current accounting of any animals or plants intentionally or accidentally exposed to or infected with a select agent (including number and species, location, and appropriate disposition); (3) An accurate, current inventory for each toxin held, including: (i) The name and characteristics; (ii) The quantity acquired from another individual or entity ( e.g. , containers, vials, tubes, etc.), date of acquisition, and the source; (iii) The initial and current quantity amount ( e.g. , milligrams, milliliters, grams, etc.); (iv) The toxin used and purpose of use, quantity, date(s) of the use and by whom; (v) Where stored ( e.g. , building, room, and freezer or other storage container); (vi) When moved from storage and by whom and when returned to storage and by whom, including quantity amount; (vii) Records created under § 331.16 (Transfers); (viii) For intra-entity transfers (sender and the recipient are covered by the same certificate of registration), the toxin, the quantity transferred, the date of transfer, the sender, and the recipient; (ix) Records created under § 331.19 (Notification of theft, loss, or release); (x) If destroyed, the quantity of toxin destroyed, the date of such action, and by whom. (4) A current list of all individuals that have been granted access approval by the Administrator or the HHS Secretary; (5) Information about all entries into areas containing select agents or toxins, including the name of the individual, name of the escort (if applicable), and the date and time of entry; (6) Accurate, current records created under § 331.9(c) (Responsible official), § 331.11 (Security), § 331.12 (Biocontainment), § 331.14 (Incident response), and § 331.15 (Training); (7) A written explanation of any discrepancies; and (8) For select agents or material containing select agents or regulated nucleic acids that can produce infectious forms of any select agent virus that have been subjected to a validated inactivation procedure or a procedure for removal of viable select agent: (i) A written description of the validated inactivation procedure or viable select agent removal method used, including validation data; (ii) A written description of the viability testing protocol used; (iii) A written description of the investigation conducted by the entity responsible official involving an inactivation or viable select agent removal failure and the corrective actions taken; (iv) The name of each individual performing the validated inactivation or viable select agent removal method; (v) The date(s) the validated inactivation or viable select agent removal method was completed; (vi) The location where the validated inactivation or viable select agent removal method was performed; and (vii) A certificate, signed by the principal investigator, that includes the date of inactivation or viable select agent removal, the validated inactivation or viable select agent removal method used, and the name of the principal investigator. A copy of the certificate must accompany any transfer of inactivated or select agent removed material. (b) The individual or entity must implement a system to ensure that all records and databases created under this part are accurate and legible, have controlled access, and that their authenticity may be verified. (c) The individual or entity must promptly produce upon request any information that is related to the requirements of this part but is not otherwise contained in a record required to be kept by this section. The location of such information may include, but is not limited to, biocontainment certifications, laboratory notebooks, institutional biosafety and/or animal use committee minutes and approved protocols, and records associated with occupational health and suitability programs. All records created under this part must be maintained for 3 years." 7:7:5.1.1.1.9.0.47.18,7,Agriculture,III,,331,"PART 331—POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS",,,,§ 331.18 Inspections.,APHIS,,,,"(a) Without prior notification, APHIS must be allowed to inspect any site at which activities regulated under this part are conducted and must be allowed to inspect and copy any records relating to the activities covered by this part. (b) Prior to issuing a certificate of registration to an individual or entity, APHIS may inspect and evaluate their premises and records to ensure compliance with this part." 7:7:5.1.1.1.9.0.47.19,7,Agriculture,III,,331,"PART 331—POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS",,,,"§ 331.19 Notification of theft, loss, or release.",APHIS,,,"[70 FR 13278, Mar. 18, 2005, as amended at 77 FR 61077, Oct. 5, 2012]","(a) An individual or entity must immediately notify APHIS or CDC upon discovery of the theft or loss of a select agent or toxin. Thefts or losses must be reported even if the select agent or toxin is subsequently recovered or the responsible parties are identified. (1) The theft or loss of a select agent or toxin must be reported by telephone, facsimile, or e-mail. The following information must be provided: (i) The name of the select agent or toxin and any identifying information ( e.g. , strain or other characterization information); (ii) An estimate of the quantity stolen or lost; (iii) An estimate of the time during which the theft or loss occurred; (iv) The location (building, room) from which the theft or loss occurred; and (v) The list of Federal, State, or local law enforcement agencies to which the individual or entity reported, or intends to report, the theft or loss. (2) A completed APHIS/CDC Form 3 must be submitted within 7 calendar days. (b) An individual or entity must notify APHIS or CDC immediately upon discovery of a release of a select agent or toxin outside of the primary barriers of the biocontainment area. (1) The release of a select agent or toxin must be reported by telephone, facsimile, or e-mail. The following information must be provided: (i) The name of the select agent or toxin and any identifying information ( e.g. , strain or other characterization information); (ii) An estimate of the quantity released; (iii) The time and duration of the release; (iv) The location (building, room) from which the release occurred; and (v) The number of individuals potentially exposed at the entity; (vi) Actions taken to respond to the release; and (vii) Hazards posed by the release. (2) A completed APHIS/CDC Form 3 must be submitted within 7 calendar days." 7:7:5.1.1.1.9.0.47.2,7,Agriculture,III,,331,"PART 331—POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS",,,,§ 331.2 Purpose and scope.,APHIS,,,,"This part implements the provisions of the Agricultural Bioterrorism Protection Act of 2002 setting forth the requirements for possession, use, and transfer of select agents and toxins. The biological agents and toxins listed in this part have the potential to pose a severe threat to plant health or plant products." 7:7:5.1.1.1.9.0.47.20,7,Agriculture,III,,331,"PART 331—POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS",,,,§ 331.20 Administrative review.,APHIS,,,"[77 FR 61077, Oct. 5, 2012]","(a) An individual or entity may appeal a denial, revocation, or suspension of registration under this part. The appeal must be in writing, state the factual basis for the appeal, and be submitted to the Administrator within 30 calendar days of the decision. (b) An individual may appeal a denial, limitation, or revocation of access approval under this part. The appeal must be in writing, state the factual basis for the appeal, and be submitted to the Administrator within 180 calendar days of the decision. (c) The Administrator's decision constitutes final agency action." 7:7:5.1.1.1.9.0.47.3,7,Agriculture,III,,331,"PART 331—POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS",,,,§ 331.3 PPQ select agents and toxins.,APHIS,,,"[70 FR 13278, Mar. 18, 2005, as amended at 73 FR 61331, Oct. 16, 2008; 77 FR 61075, Oct. 5, 2012; 79 FR 26830, May 12, 2014; 82 FR 6204, Jan. 19. 2017; 83 FR 48201, Sept. 24, 2018; 89 FR 101845, Dec. 17, 2024]","(a) Except as provided in paragraphs (d) and (e) of this section, the Administrator has determined that the biological agents and toxins listed in this section have been determined to have the potential to pose a severe threat to plant health or to plant products. (b) PPQ select agents and toxins are: (1) Coniothyrium glycines, (formerly Phoma glycinicola, Pyrenochaeta glycines ); (2) Ralstonia solanacearum; (3) Rathayibacter toxicus; (4) Sclerophthora rayssiae; (5) Synchytrium endobioticum; and (6) Xanthomonas oryzae. (1) Coniothyrium glycines, (formerly Phoma glycinicola, Pyrenochaeta glycines ); (2) Ralstonia solanacearum; (3) Rathayibacter toxicus; (4) Sclerophthora rayssiae; (5) Synchytrium endobioticum; and (6) Xanthomonas oryzae. (c) Genetic elements, recombinant and/or synthetic nucleic acids, and recombinant and/or synthetic organisms: (1) Nucleic acids that can produce infectious forms of any of the select agent viruses listed in paragraph (b) of this section. (2) Recombinant and/or synthetic nucleic acids that encode for the functional forms of any toxin listed in paragraph (b) of this section if the nucleic acids: (i) Can be expressed in vivo or in vitro ; or (ii) Are in a vector or recombinant host genome and can be expressed in vivo or in vitro. (3) Select agents and toxins listed in paragraph (b) of this section that have been genetically modified. (d) Select agents or toxins that meet any of the following criteria are excluded from the requirements of this part: (1) Any select agent or toxin that is in its naturally occurring environment, provided that the agent or toxin has not been intentionally introduced, cultivated, collected, or otherwise extracted from its natural source. (2) Nonviable select agents or nontoxic toxins. (3) A select agent or toxin that has been subjected to decontamination or a destruction procedure when intended for waste disposal. (4) A select agent or regulated nucleic acids that can produce infectious forms of any select agent virus that has been subjected to a validated inactivation procedure that is confirmed through a viability testing protocol. Surrogate strains that are known to possess equivalent properties with respect to inactivation can be used to validate an inactivation procedure; however, if there are known strain-to-strain variations in the resistance of a select agent to an inactivation procedure, then an inactivation procedure validated on a lesser resistant strain must also be validated on the more resistant strains. (5) Material containing a select agent that is subjected to a procedure that removes all viable select agent cells, spores, or virus particles if the material is subjected to a viability testing protocol to ensure that the removal method has rendered the material free of all viable select agent. (6) A select agent or regulated nucleic acids that can produce infectious forms of any select agent virus not subjected to a validated inactivation procedure or material containing a select agent not subjected to a procedure that removes all viable select agent cells, spores, or virus particles if the material is determined by the Administrator to be effectively inactivated or effectively removed. To apply for a determination an individual or entity must submit a written request and supporting scientific information to APHIS. A written decision granting or denying the request will be issued. (7) A PPQ select toxin identified in an original food sample or clinical sample. (8) Waste generated during the delivery of patient care by health care professionals from a patient diagnosed with an illness or condition associated with a select agent, where that waste is decontaminated or transferred for destruction by complying with State and Federal regulations within 7 calendar days of the conclusion of patient care. (9) Any subspecies of Ralstonia solanacearum except race 3, biovar 2 and all subspecies of Sclerophthora rayssiae except var. zeae, provided that the individual or entity can identify that the agent is within the exclusion category. (e) An attenuated strain of a select agent or a select toxin modified to be less potent or toxic may be excluded from the requirements of this part based upon a determination by the Administrator that the attenuated strain or modified toxin does not pose a severe threat to plant health or plant products. (1) To apply for exclusion, an individual or entity must submit a written request and supporting scientific information. A written decision granting or denying the request will be issued. An exclusion will be effective upon notification to the applicant. Exclusions will be listed on the National Select Agent Registry Web site at http://www.selectagents.gov/. (2) If an excluded attenuated strain or modified toxin is subjected to any manipulation that restores or enhances its virulence or toxic activity, the resulting select agent or toxin will be subject to the requirements of this part. (3) An individual or entity may make a written request to the Administrator for reconsideration of a decision denying an application for the exclusion of an attenuated strain of a select agent or a select toxin modified to be less potent or toxic. The written request for reconsideration must state the facts and reasoning upon which the individual or entity relies to show the decision was incorrect. The Administrator will grant or deny the request for reconsideration as promptly as circumstances allow and will state, in writing, the reasons for the decision. (f) Any select agent or toxin seized by a Federal law enforcement agency will be excluded from the requirements of this part during the period between seizure of the agent or toxin and the transfer or destruction of such agent or toxin provided that: (1) As soon as practicable, the Federal law enforcement agency transfers the seized agent or toxin to an entity eligible to receive such agent or toxin or destroys the agent or toxin by a recognized sterilization or inactivation process. (2) The Federal law enforcement agency safeguards and secures the seized agent or toxin against theft, loss, or release, and reports any theft, loss, or release of such agent or toxin. (3) The Federal law enforcement agency reports the seizure of the select agent or toxin to APHIS or CDC. The seizure must be reported within 24 hours by telephone, facsimile, or e-mail. This report must be followed by submission of APHIS/CDC Form 4 within 7 calendar days after seizure of the select agent or toxin. A copy of the completed form must be maintained for 3 years. (4) The Federal law enforcement agency reports the final disposition of the select agent or toxin to APHIS or CDC by submission of APHIS/CDC Form 4. A copy of the completed form must be maintained for 3 years." 7:7:5.1.1.1.9.0.47.4,7,Agriculture,III,,331,"PART 331—POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS",,,,§ 331.4 [Reserved],APHIS,,,, 7:7:5.1.1.1.9.0.47.5,7,Agriculture,III,,331,"PART 331—POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS",,,,§ 331.5 Exemptions.,APHIS,,,"[70 FR 13278, Mar. 18, 2005, as amended at 82 FR 6204, Jan. 19, 2017]","(a) Diagnostic laboratories and other entities that possess, use, or transfer a select agent or toxin that is contained in a specimen presented for diagnosis or verification will be exempt from the requirements of this part for such agent or toxin contained in the specimen, provided that: (1) Unless directed otherwise by the Administrator, within 7 calendar days after identification of the select agent or toxin, the select agent or toxin is transferred in accordance with § 331.16 or destroyed on-site by a recognized sterilization or inactivation process. (2) The agent or toxin is secured against theft, loss, or release during the period between identification of the agent or toxin and transfer or destruction of such agent or toxin, and any theft, loss, or release of such agent or toxin is reported. (3) The identification of the agent or toxin is reported to APHIS or CDC, the specimen provider, and to other appropriate authorities when required by Federal, State, or local law by telephone, facsimile, or email. This report must be followed by submission of APHIS/CDC Form 4 to APHIS or CDC within 7 calendar days after identification. (b) In addition to the exemption provided in paragraph (a) of this section, the Administrator may grant a specific exemption upon a showing of good cause and upon his or her determination that such exemption is consistent with protecting plant health or plant products. An individual or entity may request in writing an exemption from the requirements of this part. If granted, such exemptions are valid for a maximum of 3 years; thereafter, an individual or entity must request a new exemption. If a request for exemption is denied, an individual or entity may request reconsideration in writing to the Administrator. The request for reconsideration must state all of the facts and reasons upon which the individual or entity relies to show that the exemption was wrongfully denied. The Administrator will grant or deny the request for reconsideration as promptly as circumstances allow and will state, in writing, the reasons for the decision." 7:7:5.1.1.1.9.0.47.6,7,Agriculture,III,,331,"PART 331—POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS",,,,§ 331.6 [Reserved],APHIS,,,, 7:7:5.1.1.1.9.0.47.7,7,Agriculture,III,,331,"PART 331—POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS",,,,§ 331.7 Registration and related security risk assessments.,APHIS,,,"[70 FR 13278, Mar. 18, 2005, as amended at 82 FR 6205, Jan. 19, 2017]","(a) Unless exempted under § 331.5, an individual or entity shall not possess, use, or transfer any select agent or toxin without a certificate of registration issued by the Administrator. (b) As a condition of registration, each entity is required to be in compliance with the requirements of this part for select agents and toxins listed on the registration regardless of whether the entity is in actual possession of the select agent or toxin. With regard to toxins, the entity registered for possession, use, or transfer of a toxin must be in compliance with the requirements of this part regardless of the amount of toxins currently in its possession. (c) As a condition of registration, each entity must designate an individual to be its responsible official. While most registrants are likely to be entities, in the event that an individual applies for and is granted a certificate of registration, the individual will be considered the responsible official. (d)(1) As a condition of registration, the following must be approved by the Administrator or the HHS Secretary based on a security risk assessment by the Attorney General: (i) The individual or entity; (ii) The responsible official; and (iii) Unless otherwise exempted under this section, any individual who owns or controls the entity. (2) Federal, State, or local governmental agencies, including public accredited academic institutions, are exempt from the security risk assessments for the entity and the individual who owns or controls such entity. (3) An individual will be deemed to own or control an entity under the following conditions: 1 1 These conditions may apply to more than one individual. (i) For a private institution of higher education, an individual will be deemed to own or control the entity if the individual is in a managerial or executive capacity with regard to the entity's select agents or toxins or with regard to the individuals with access to the select agents or toxins possessed, used, or transferred by the entity. (ii) For entities other than institutions of higher education, an individual will be deemed to own or control the entity if the individual: (A) Owns 50 percent or more of the entity, or is a holder or owner of 50 percent or more of its voting stock; or (B) Is in a managerial or executive capacity with regard to the entity's select agents or toxins or with regard to the individuals with access to the select agents or toxins possessed, used, or transferred by the entity. (4) An entity will be considered to be an institution of higher education if it is an institution of higher education as defined in section 101(a) of the Higher Education Act of 1965 (20 U.S.C. 1001(a)), or is an organization described in 501(c)(3) of the Internal Revenue Code of 1986, as amended (26 U.S.C. 501(c)(3)). (5) To obtain a security risk assessment, an individual or entity must submit the information necessary to conduct a security risk assessment to the Attorney General. (e) To apply for a certificate of registration for only PPQ select agents or toxins, or for PPQ and VS select agents or toxins, an individual or entity must submit the information requested in the registration application package (APHIS/CDC Form 1) to APHIS. To apply for a certificate of registration for overlap select agents or toxins, overlap select agents or toxins and any combination of PPQ or VS select agents or toxins, or HHS select agents or toxins and any combination of PPQ or VS select agents or toxins, an individual or entity must submit the information requested in the registration application package (APHIS/CDC Form 1) to APHIS or CDC, but not both. (f) Prior to the issuance of a certificate of registration, the responsible official must promptly provide notification of any changes to the application for registration by submitting the relevant page(s) of the registration application. (g) The issuance of a certificate of registration may be contingent upon inspection or submission of additional information, such as the security plan, biosafety plan, incident response plan, or any other documents required to be prepared under this part. (h) A certificate of registration will be valid for one physical location (a room, a building, or a group of buildings) where the responsible official will be able to perform the responsibilities required in this part, for specific select agents or toxins, and for specific activities. (i) A certificate of registration may be amended to reflect changes in circumstances ( e.g. , replacement of the responsible official or other personnel changes, changes in ownership or control of the entity, changes in the activities involving any select agents or toxins, or the addition or removal of select agents or toxins). (1) Prior to any change, the responsible official must apply for an amendment to a certificate of registration by submitting the relevant page(s) of the registration application. 2 2 Depending on the change, a security risk assessment by the Attorney General may also be required ( e.g. , replacement of the responsible official, changes in ownership or control of the entity, new researchers or graduate students, etc.). (2) The responsible official will be notified in writing if an application to amend a certificate of registration has been approved. Approval of an amendment may be contingent upon an inspection or submission of additional information, such as the security plan, biosafety plan, incident response plan, or any other documents required to be prepared under this part. (3) No change may be made without such approval. (j) An entity must immediately notify APHIS or CDC if it loses the services of its responsible official. In the event that an entity loses the services of its responsible official, an entity may continue to possess or use select agents or toxins only if it appoints as the responsible official another individual who has been approved by the Administrator or the HHS Secretary following a security risk assessment by the Attorney General and who meets the requirements of this part. (k) A certificate of registration will be terminated upon the written request of the entity if the entity no longer possesses or uses any select agents or toxins and no longer wishes to be registered. (l) A certificate of registration will be valid for a maximum of 3 years." 7:7:5.1.1.1.9.0.47.8,7,Agriculture,III,,331,"PART 331—POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS",,,,"§ 331.8 Denial, revocation, or suspension of registration.",APHIS,,,,"(a) An application may be denied or a certificate of registration revoked or suspended if: (1) The individual or entity, the responsible official, or an individual who owns or controls the entity is within any of the categories described in 18 U.S.C. 175b; (2) The individual or entity, the responsible official, or an individual who owns or controls the entity is reasonably suspected by any Federal law enforcement or intelligence agency of: (i) Committing a crime set forth in 18 U.S.C. 2332b(g)(5); or (ii) Knowing involvement with an organization that engages in domestic or international terrorism (as defined in 18 U.S.C. 2331) or with any other organization that engages in intentional crimes of violence; or (iii) Being an agent of a foreign power as defined in 50 U.S.C. 1801; (3) The individual or entity does not meet the requirements of this part; 3 or 3 If registration is denied for this reason, we may provide technical assistance and guidance. (4) It is determined that such action is necessary to protect plant health or plant products. (b) Upon revocation or suspension of a certificate of registration, the individual or entity must: (1) Immediately stop all use of each select agent or toxin covered by the revocation or suspension order; (2) Immediately safeguard and secure each select agent or toxin covered by the revocation or suspension order from theft, loss, or release; and (3) Comply with all disposition instructions issued by the Administrator for each select agent or toxin covered by the revocation or suspension. (c) Denial of an application for registration and revocation or suspension of registration may be appealed under § 331.20. However, any denial of an application for registration or revocation or suspension of a certificate of registration will remain in effect until a final agency decision has been rendered." 7:7:5.1.1.1.9.0.47.9,7,Agriculture,III,,331,"PART 331—POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS",,,,§ 331.9 Responsible official.,APHIS,,,"[70 FR 13278, Mar. 18, 2005, as amended at 77 FR 61075, Oct. 5, 2012; 82 FR 6205, Jan. 19, 2017]","(a) An individual or entity required to register under this part must designate an individual to be the responsible official. The responsible official must: (1) Be approved by the Administrator or the HHS Secretary following a security risk assessment by the Attorney General. (2) Be familiar with the requirements of this part. (3) Have authority and responsibility to act on behalf of the entity. (4) Ensure compliance with the requirements of this part. (5) Have a physical (and not merely a telephonic or audio/visual) presence at the registered entity to ensure that the entity is in compliance with the select agent regulations and be able to respond in a timely manner to onsite incidents involving select agents and toxins in accordance with the entity's incident response plan. (6) Ensure that annual inspections are conducted of each registered space where select agents or toxins are stored or used in order to ensure compliance with the requirements of this part. The results of each inspection must be documented, and any deficiencies identified during an inspection must be corrected and the corrections documented. (7) Ensure that individuals are provided the contact information for the USDA Office of Inspector General Hotline and the HHS Office of Inspector General Hotline so that they may anonymously report any biosafety/biocontainment or security concerns related to select agents and toxins. (8) Investigate to determine the reason for any failure of a validated inactivation procedure or any failure to remove viable select agent from material. If the responsible official is unable to determine the cause of a deviation from a validated inactivation procedure or a viable select agent removal method; or receives any report of any inactivation failure after the movement of material to another location, the responsible official must report immediately by telephone or email the inactivation or viable agent removal method failure to APHIS or CDC. (9) Review, and revise as necessary, each of the entity's validated inactivation procedures or viable select agent removal methods. The review must be conducted annually or after any change in principal investigator, change in the validated inactivation procedure or viable select agent removal method, or failure of the validated inactivation procedure or viable select agent removal method. The review must be documented and training must be conducted if there are any changes to the validated inactivation procedure, viable select agent removal method, or viability testing protocol. (b) An entity may designate one or more individuals to serve as an alternate responsible official who acts for the responsible official in his/her absence. These individuals must have the authority and control to ensure compliance with the regulations when acting as the responsible official. (c) The responsible official must report the identification and final disposition of any select agent or toxin contained in a specimen for diagnosis or verification. (1) The identification of the select agent or toxin must be immediately reported by telephone, facsimile, or e-mail. The final disposition of the agent or toxin must be reported by submission of APHIS/CDC Form 4 within 7 calendar days after identification. A copy of the completed form must be maintained for 3 years. (2) Less stringent reporting may be required during agricultural emergencies or outbreaks, or in endemic areas." 9:9:2.0.2.1.27.0.7.1,9,Animals and Animal Products,III,A,331,PART 331—SPECIAL PROVISIONS FOR DESIGNATED STATES AND TERRITORIES; AND FOR DESIGNATION OF ESTABLISHMENTS WHICH ENDANGER PUBLIC HEALTH AND FOR SUCH DESIGNATED ESTABLISHMENTS,,,,§ 331.1 Definition of “State”.,FSIS,,,,"For purposes of this part, the term “State” means any State (including the Commonwealth of Puerto Rico) or organized Territory." 9:9:2.0.2.1.27.0.7.2,9,Animals and Animal Products,III,A,331,PART 331—SPECIAL PROVISIONS FOR DESIGNATED STATES AND TERRITORIES; AND FOR DESIGNATION OF ESTABLISHMENTS WHICH ENDANGER PUBLIC HEALTH AND FOR SUCH DESIGNATED ESTABLISHMENTS,,,,§ 331.2 [Reserved],FSIS,,,, 9:9:2.0.2.1.27.0.7.3,9,Animals and Animal Products,III,A,331,PART 331—SPECIAL PROVISIONS FOR DESIGNATED STATES AND TERRITORIES; AND FOR DESIGNATION OF ESTABLISHMENTS WHICH ENDANGER PUBLIC HEALTH AND FOR SUCH DESIGNATED ESTABLISHMENTS,,,,§ 331.3 States designated under paragraph 301(c) of the Act; application of regulations.,FSIS,,,"[35 FR 19667, Dec. 29, 1970, as amended at 36 FR 12004, June 24, 1971; 41 FR 18089, Apr. 30, 1976; 62 FR 45026, Aug. 25, 1997; 64 FR 56416, Oct. 20, 1999; 78 FR 66837, Nov. 7, 2013; 90 FR 27226, June 26, 2025]","The provisions of the regulations in this subchapter apply to operations and transactions wholly within each State designated under paragraph 301(c) of the Act, except as otherwise provided in this section. (The provisions of the regulations apply in all respects to operations and transactions in or for commerce.) (a) Each establishment located in such a designated State shall be granted inspection required under § 302.1(a)(2) of this subchapter only if it is found, upon a combined evaluation of its premises, facilities, and operating procedures, to be capable of producing products that are not adulterated or misbranded. (b) Section 305.2 of this subchapter will apply to establishments required to have inspection under § 302.1(a)(2) of this subchapter, except that existing interconnections between official and unofficial establishments will be permitted if it is determined in specific cases that the interconnections are such that transfer of inedible product into the official establishment would be difficult or unusual, and any such transfers are strictly prohibited, except as permitted under other provisions of this subchapter. It is essential that separation of facilities be maintained to the extent necessary to assure that inedible product does not enter the official establishment contrary to the regulations in this subchapter. (c) Sections 416.2(c), (d), (e), (f), and (h) of this chapter shall apply to such establishments. (d) Section 314.2 of this subchapter shall apply to such establishments, except that a separate room or compartment need not be provided for inedible products if they can be handled so that they do not create insanitary conditions in any room or compartment used for edible products or otherwise render any edible products adulterated and do not interfere with the conduct of inspection. For example, intestines, paunch contents, feet, and hides might be accumulated on the kill floor in clean, watertight drums with close fitting covers if there is sufficient space to store them out of the way until the close of the day's operation. (e) Sections 316.7, 317.3, and 412.1 of this chapter apply to such establishments, except as provided in this paragraph (e). (1) The operator of each such establishment will, prior to the inauguration of inspection, identify all labeling and marking devices in use, or proposed for use, (upon the date of inauguration of inspection) to the Front Line Supervisor of the circuit in which the establishment is located. Temporary approval, pending formal approval under §§ 316.7, 317.3, and 412.1 of this chapter, will be granted by the Front Line Supervisor for labeling and marking devices that he determines are neither false nor misleading, provided the official inspection legend bearing the official establishment number is applied to the principal display panel of each label, either by a mechanical printing device or a self-destructive pressure sensitive sticker, and provided the label shows the true product name, an accurate ingredient statement, the name and address of the manufacturer, packer, or distributor, and any other features required by section 1(n) of the Act. (2) The circuit supervisor will forward one copy of each item of labeling and a description of each marking device for which he has granted temporary approval to the Washington, DC, office of the Labeling and Packaging Staff and will retain one copy in a temporary approval file for the establishment. (3) The operator of the official establishment shall promptly forward a copy of each item of labeling and a description of each marking device for which temporary approval has been granted by the Front Line Supervisor (showing any modifications required by the Front Line Supervisor) to the FSIS Labeling and Program Delivery Staff, accompanied by the formula and details of preparation and packaging for each product. Within 90 days after inauguration of inspection, all labeling material and marking devices temporarily approved by the Front Line Supervisor must receive approval as required by §§ 316.7, 317.3, and 412.1 of this chapter, or their use must be discontinued. (4) The circuit supervisor will also review all shipping containers to insure that they do not have any false or misleading labeling and are otherwise not misbranded. Modifications of unacceptable information on labeling material by the use of self-destructive pressure sensitive tape or by blocking out with an ink stamp will be authorized on a temporary basis to permit the maximum allowable use of all labeling materials on hand. All unacceptable labeling material which is not modified to comply with the requirements of this subchapter must be destroyed or removed from the official establishment. (f) Sections 320.1, 320.2, 320.3, 320.4, 320.5, 325.20, and 325.21 apply to operations and transactions not in or for commerce in a State designated under paragraph 301(c) only if the State is also designated under section 205 of the Act and if such provisions are applicable. (g) Section 321.1(a) of this subchapter will not apply to States designated under paragraph 301(c) of the Act. (h) Parts 322 and 327 and § 325.3 of this subchapter relating to exports and imports do not apply to operations and transactions solely in or for intrastate commerce. (i) Part 325 of this subchapter will apply to establishments required to have inspection under § 302.1(a)(2) of this subchapter and to operations and transactions solely in or for intrastate commerce, except as provided in paragraphs (h) and (j) of this section. (j) Sections 325.4, 325.15, and 325.1(b) of this subchapter will not apply to require a certificate, or evidence thereof, for the distribution solely within any designated State of products that are U.S. inspected and passed and so marked." 9:9:2.0.2.1.27.0.7.4,9,Animals and Animal Products,III,A,331,PART 331—SPECIAL PROVISIONS FOR DESIGNATED STATES AND TERRITORIES; AND FOR DESIGNATION OF ESTABLISHMENTS WHICH ENDANGER PUBLIC HEALTH AND FOR SUCH DESIGNATED ESTABLISHMENTS,,,,§ 331.4 Control and disposal of non-federally-inspected products in States designated under paragraph 301(c) of the Act.,FSIS,,,,"Upon the effective date of designation of a State under paragraph 301(c) of the Act, no products can be prepared within the State unless they are prepared under inspection pursuant to the regulations in this subchapter or are exempted from the requirement of inspection under § 303.1 of this subchapter, and no unexempted products which were prepared without any inspection can lawfully be distributed within the State. For a period of 90 days from the effective date of such designation, products which were prepared and inspected and passed under the supervision of a responsible State or local inspection agency can be distributed solely within the State, provided they are not adulterated or misbranded, except that the official inspection legend is not required. Within the 90-day period, products that have been inspected by the State or local inspection agency may be further prepared and otherwise handled in official establishments required to have inspection under § 302.1(a)(2) of this subchapter or at establishments exempted from the requirements of such inspection under § 303.1 of this subchapter, and may be distributed as provided in this section but otherwise shall be handled in accordance with § 305.4 of this subchapter. Such products shall not bear any [Federal] official inspection legends. After said 90-day period, only federally inspected and passed products may be distributed within the designated State, except as provided in § 303.1 of this subchapter." 9:9:2.0.2.1.27.0.7.5,9,Animals and Animal Products,III,A,331,PART 331—SPECIAL PROVISIONS FOR DESIGNATED STATES AND TERRITORIES; AND FOR DESIGNATION OF ESTABLISHMENTS WHICH ENDANGER PUBLIC HEALTH AND FOR SUCH DESIGNATED ESTABLISHMENTS,,,,§ 331.5 Criteria and procedure for designating establishments with operations which would clearly endanger the public health; disposition of products; application of regulations.,FSIS,,,"[35 FR 19667, Dec. 29, 1970, as amended at 83 FR 25308, May 31, 2018]","(a) An establishment preparing products solely for distribution within any State shall be designated as one producing adulterated products which would clearly endanger the public health, if: (1) Any meat or meat food product prepared at the establishment is adulterated in any of the following respects: (i) It bears or contains a pesticide chemical, food additive, or color additive, that is “unsafe” within the meaning of sections 408, 409, or 706 of the Federal Food, Drug, and Cosmetic Act or was intentionally subjected to radiation in a manner not permitted under section 409 of said Act; or if it bears or contains any other added poisonous or added deleterious substance which may render it injurious to health or make it unfit for human food; or (ii) It consists in whole or in part of any filthy, putrid, or decomposed substance or is for any other reason unsound, unhealthful, or unwholesome or otherwise unfit for human food (for example, it was prepared from meat or other ingredients exhibiting spoilage characteristics; or it is, or was prepared from, a carcass affected with a disease transmissible to humans and its condemnation would be required under part 309 or 310 of the Federal Meat Inspection regulations (9 CFR parts 309, 310) at federally inspected establishments; or (iii) It has been prepared, packed or held under insanitary conditions whereby it may have become contaminated with filth or may have been rendered injurious to health (for example if insects or vermin are not effectively controlled at the establishments, or insanitary water is used in preparing meat or meat food products for human food); or (iv) It is, in whole or in part, the product of an animal that died otherwise than by slaughter; or (v) Its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; and (2) Such adulterated articles are intended to be or are distributed from the establishment while capable of use as human food. (b) When any such establishment is identified by a Program Inspector as one producing adulterated product, which would clearly endanger public health under the criteria in paragraph (a) of this section, the following procedure will be followed: (1) The Program Inspector will informally advise the operator of the establishment concerning the deficiencies found by him and report his findings to the appropriate Regional Director for the Program. When it is determined by the Regional Director that any establishment preparing products solely for distribution within any State is producing adulterated products for distribution within such State which would clearly endanger the public health, written notification thereof will be issued to the appropriate State officials, including the Governor of the State and the appropriate Advisory Committee, for effective action under State or local law to prevent such endangering of the public health. Such written notification shall clearly specify the deficiencies deemed to result in the production of adulterated products and shall specify a reasonable time for such action under State or local law. (2) If effective action is not taken under State or local law within the specified time, written notification shall be issued by the Regional Director to the operator of the establishment, specifying the deficiencies involved and allowing him ten days to present his views or make the necessary corrections, and notifying him that failure to correct such deficiencies may result in designation of the establishment and operator thereof as subject to the provisions of titles I and IV of the Act as though engaged in commerce. (3) Thereafter the Program Inspector shall survey the establishment and designate it if he determines, in consultation with the Regional Director, that it is producing adulterated products, which would clearly endanger the public health, and formal notice of such designation will be issued to the operator of the establishment by the Regional Director. (c) Products on hand at the time of designation of an establishment under this section are subject to detention, seizure and condemnation in accordance with part 329 of this subchapter: Provided, That products that have been federally inspected and so identified and that have not been further prepared at any nonfederally inspected establishment may be released for distribution if the products appear to be not adulterated or misbranded at the time of such release. (d) No establishment designated under this section can lawfully prepare any products unless it first obtains inspection or qualifies for exemption under § 303.1 of this subchapter. All of the provisions of the regulations shall apply to establishments designated under this section, except that the exceptions provided for in § 331.3 of this part shall apply to such establishments." 9:9:2.0.2.1.27.0.7.6,9,Animals and Animal Products,III,A,331,PART 331—SPECIAL PROVISIONS FOR DESIGNATED STATES AND TERRITORIES; AND FOR DESIGNATION OF ESTABLISHMENTS WHICH ENDANGER PUBLIC HEALTH AND FOR SUCH DESIGNATED ESTABLISHMENTS,,,,§ 331.6 [Reserved],FSIS,,,,