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 10:10:2.0.1.1.23.0.142.1,10,Energy,I,,160,PART 160—TRESPASSING ON COMMISSION PROPERTY,,,,§ 160.1 Purpose.,NRC,,,"[28 FR 8400, Aug. 16, 1963, as amended at 40 FR 8794, Mar. 3, 1975; 90 FR 55634, Dec. 3, 2025]","The regulations in this part are issued for the protection and security of facilities, installations and real property subject to the proprietory jurisdiction or administration, or in the custody of, the Nuclear Regulatory Commission. The regulations in this part shall cease to have effect on January 8, 2027, unless the NRC determines that the cessation deadline should be extended to a date not more than 5 years in the future after offering the public an opportunity to provide input on the costs and benefits of this part and considering that input. The NRC will publish a document in the Federal Register announcing its determination and revising or removing this part accordingly." 10:10:2.0.1.1.23.0.142.2,10,Energy,I,,160,PART 160—TRESPASSING ON COMMISSION PROPERTY,,,,§ 160.2 Scope.,NRC,,,"[40 FR 8794, Mar. 3, 1975]","The regulations in this part apply to all facilities, installations, and real property subject to the jurisdiction or administration of the Nuclear Regulatory Commission or in its custody which have been posted with a notice of the prohibitions and penalties set forth in this part." 10:10:2.0.1.1.23.0.142.3,10,Energy,I,,160,PART 160—TRESPASSING ON COMMISSION PROPERTY,,,,§ 160.3 Trespass.,NRC,,,,"Unauthorized entry upon any facility, installation or real property subject to this part is prohibited." 10:10:2.0.1.1.23.0.142.4,10,Energy,I,,160,PART 160—TRESPASSING ON COMMISSION PROPERTY,,,,§ 160.4 Unauthorized introduction of weapons or dangerous materials.,NRC,,,,"Unauthorized carrying, transporting, or otherwise introducing or causing to be introduced any dangerous weapon, explosive, or other dangerous instrument or material likely to produce substantial injury or damage to persons or property, into or upon any facility, installation or real property subject to this part, is prohibited." 10:10:2.0.1.1.23.0.142.5,10,Energy,I,,160,PART 160—TRESPASSING ON COMMISSION PROPERTY,,,,§ 160.5 Violations and penalties.,NRC,,,,"(a) Whoever willfully violates either §§ 160.3 or 160.4 shall, upon conviction, be punishable by a fine of not more than $1,000. (b) Whoever willfully violates either §§ 160.3 or 160.4 with respect to any facility, installation or real property enclosed by a fence, wall, floor, roof, or other structural barrier shall be guilty of a misdemeanor and, upon conviction, shall be punished by a fine of not to exceed $5,000 or imprisonment for not more than one year, or both." 10:10:2.0.1.1.23.0.142.6,10,Energy,I,,160,PART 160—TRESPASSING ON COMMISSION PROPERTY,,,,§ 160.6 Posting.,NRC,,,,"Notices stating the pertinent prohibitions of §§ 160.3 and 160.4 and penalties of § 160.5 will be conspicuously posted at all entrances of each designated facility, installation or parcel of real property and at such intervals along the perimeter as will provide reasonable assurance of notice to persons about to enter." 10:10:2.0.1.1.23.0.142.7,10,Energy,I,,160,PART 160—TRESPASSING ON COMMISSION PROPERTY,,,,§ 160.7 Effective date of prohibition on designated locations.,NRC,,,,"The prohibitions in §§ 160.3 and 160.4 shall take effect as to any facility, installation or real property on publication in the Federal Register of the notice designating the facility, installation or real property and posting in accordance with § 160.6." 10:10:2.0.1.1.23.0.142.8,10,Energy,I,,160,PART 160—TRESPASSING ON COMMISSION PROPERTY,,,,§ 160.8 Applicability of other laws.,NRC,,,,Nothing in this part shall be construed to affect the applicability of the provisions of State or other Federal laws. 17:17:2.0.1.1.26.0.1.1,17,Commodity and Securities Exchanges,I,,160,PART 160—PRIVACY OF CONSUMER FINANCIAL INFORMATION UNDER TITLE V OF THE GRAMM-LEACH-BLILEY ACT,,,,§ 160.1 Purpose and scope.,CFTC,,,"[66 FR 21252, Apr. 27, 2001, as amended at 75 FR 55450, Sept. 10, 2010; 76 FR 43878, July 22, 2011]","(a) Purpose. This part governs the treatment of nonpublic personal information about consumers by the financial institutions listed in paragraph (b) of this section. This part: (1) Requires a financial institution to provide notice to customers about its privacy policies and practices; (2) Describes the conditions under which a financial institution may disclose nonpublic personal information about consumers to nonaffiliated third parties; and (3) Provides a method for consumers to prevent a financial institution from disclosing nonpublic personal information to most nonaffiliated third parties by “opting out” of that disclosure, subject to the exceptions in §§ 160.13, 160.14, and 160.15. (b) Scope. This part applies only to nonpublic personal information about individuals who obtain financial products or services primarily for personal, family, or household purposes from the institutions listed below. This part does not apply to information about companies or about individuals who obtain financial products or services primarily for business, commercial, or agricultural purposes. This part applies to all futures commission merchants, retail foreign exchange dealers, commodity trading advisors, commodity pool operators, introducing brokers, major swap participants and swap dealers that are subject to the jurisdiction of the Commission, regardless whether they are required to register with the Commission. These entities are hereinafter referred to in this part as “you.” This part does not apply to foreign (non-resident) futures commission merchants, retail foreign exchange dealers, commodity trading advisors, commodity pool operators, introducing brokers, major swap participants and swap dealers that are not registered with the Commission." 17:17:2.0.1.1.26.0.1.2,17,Commodity and Securities Exchanges,I,,160,PART 160—PRIVACY OF CONSUMER FINANCIAL INFORMATION UNDER TITLE V OF THE GRAMM-LEACH-BLILEY ACT,,,,§ 160.2 Model privacy form and examples.,CFTC,,,"[74 FR 62974, Dec. 1, 2009]","(a) Model privacy form. Use of the model privacy form in appendix A of this part, consistent with the instructions in appendix A, constitutes compliance with the notice content requirements of §§ 160.6 and 160.7 of this part, although use of the model privacy form is not required. (b) Examples. The examples in this part are not exclusive. Compliance with an example, to the extent applicable, constitutes compliance with this part." 17:17:2.0.1.1.26.0.1.3,17,Commodity and Securities Exchanges,I,,160,PART 160—PRIVACY OF CONSUMER FINANCIAL INFORMATION UNDER TITLE V OF THE GRAMM-LEACH-BLILEY ACT,,,,§ 160.3 Definitions.,CFTC,,,"[66 FR 21252, Apr. 27, 2001, as amended at 75 FR 55450, Sept. 10, 2010; 76 FR 43878, July 22, 2011]","For purposes of this part, unless the context requires otherwise: (a) Affiliate of a futures commission merchant, retail foreign exchange dealer, commodity trading advisor, commodity pool operator, introducing broker, major swap participant, or swap dealer means any company that controls, is controlled by, or is under common control with a futures commission merchant, retail foreign exchange dealer, commodity trading advisor, commodity pool operator, introducing broker, major swap participant, or swap dealer that is subject to the jurisdiction of the Commission. In addition, a futures commission merchant, retail foreign exchange dealer, commodity trading advisor, commodity pool operator, introducing broker, major swap participant, or swap dealer subject to the jurisdiction of the Commission will be deemed an affiliate of a company for purposes of this part if: (1) That company is regulated under title V of the GLB Act by the Bureau of Consumer Financial Protection or by a Federal functional regulator other than the Commission; and (2) Rules adopted by the Bureau of Consumer Financial Protection or another Federal functional regulator under title V of the GLB Act treat the futures commission merchant, retail foreign exchange dealer, commodity trading advisor, commodity pool operator, introducing broker, major swap participant, or swap dealer as an affiliate of that company. (b)(1) Clear and conspicuous means that a notice is reasonably understandable and designed to call attention to the nature and significance of the information in the notice. (2) Examples —(i) Reasonably understandable. Your notice will be reasonably understandable if you: (A) Present the information in the notice in clear, concise sentences, paragraphs and sections; (B) Use short explanatory sentences or bullet lists whenever possible; (C) Use definite, concrete, everyday words and active voice whenever possible; (D) Avoid multiple negatives; (E) Avoid legal and highly technical business terminology whenever possible; and (F) Avoid explanations that are imprecise and readily subject to different interpretations. (ii) Designed to call attention. Your notice is designed to call attention to the nature and significance of the information in it if you: (A) Use a plain-language heading to call attention to the notice; (B) Use a typeface and type size that are easy to read; (C) Provide wide margins and ample line spacing; (D) Use boldface or italics for key words; and (E) Use distinctive type size, style and graphic devices, such as shading or sidebars when you combine your notice with other information. (iii) Notices on web sites. If you provide notice on a web page, you design your notice to call attention to the nature and significance of the information in it if you use text or visual cues to encourage scrolling down the page, if necessary to view the entire notice, and ensure that other elements on the web site, such as text, graphics, hyperlinks or sound, do not distract from the notice, and you either: (A) Place the notice on a screen that consumers frequently access, such as a page on which transactions are conducted; or (B) Place a link on a screen that consumers frequently access, such as a page on which transactions are conducted, that connects directly to the notice and is labeled appropriately to convey the importance, nature and relevance of the notice. (c) Collect means to obtain information that you organize or can retrieve by the name of an individual or by identifying number, symbol or other identifying particular assigned to the individual, irrespective of the source of the underlying information. (d) Commission means the Commodity Futures Trading Commission. (e) Commodity pool operator has the same meaning as in section 1a(5) of the Commodity Exchange Act, as amended, and includes anyone registered as such under the Act. (f) Commodity trading advisor has the same meaning as in section 1a(6) of the Commodity Exchange Act, as amended, and includes anyone registered as such under the Act. (g) Company means any corporation, limited liability company, business trust, general or limited partnership, association or similar organization. (h)(1) Consumer means an individual who obtains or has obtained a financial product or service from you that is to be used primarily for personal, family or household purposes, or that individual's legal representative. (2) Examples. (i) An individual is your consumer if he or she provides nonpublic personal information to you in connection with obtaining or seeking to obtain brokerage or advisory services, whether or not you provide services to the individual or establish a continuing relationship with the individual. (ii) An individual is not your consumer if he or she provides you only with his or her name, address and general areas of investment interest in connection with a request for a brochure or other information about financial products or services. (iii) An individual is not your consumer if he or she has an account with another futures commission merchant (originating futures commission merchant) for which you provide clearing services for an account in the name of the originating futures commission merchant. (iv) An individual who is a consumer of another financial institution is not your consumer solely because you act as agent for, or provide processing or other services to, that financial institution. (v) An individual is not your consumer solely because he or she has designated you as trustee for a trust. (vi) An individual is not your consumer solely because he or she is a beneficiary of a trust for which you are a trustee. (vii) An individual is not your consumer solely because he or she is a participant or a beneficiary of an employee benefit plan that you sponsor or for which you act as a trustee or fiduciary. (i) Consumer reporting agency has the same meaning as in section 603(f) of the Fair Credit Reporting Act (15 U.S.C. 1681a(f)). (j) Control of a company means the power to exercise a controlling influence over the management or policies of a company whether through ownership of securities, by contract, or otherwise. Any person who owns beneficially, either directly or through one or more controlled companies, more than 25 percent of the voting securities of any company is presumed to control the company. Any person who does not own more than 25 percent of the voting securities of a company will be presumed not to control the company. (k) Customer means a consumer who has a customer relationship with you. (l)(1) Customer relationship means a continuing relationship between a consumer and you under which you provide one or more financial products or services to the consumer that are to be used primarily for personal, family or household purposes. (2) Examples —(i) Continuing relationship. A consumer has a continuing relationship with you if: (A) You are a futures commission merchant through whom a consumer has opened an account, or that carries the consumer's account on a fully-disclosed basis, or that effects or engages in commodity interest transactions with or for a consumer, even if you do not hold any assets of the consumer. (B) You are a retail foreign exchange dealer with whom a consumer has opened an account, or that effects or engages in retail forex transactions with or for a consumer, even if you do not hold any assets of the consumer; (C) You are an introducing broker that solicits or accepts specific orders for trades; (D) You are a commodity trading advisor with whom a consumer has a contract or subscription, either written or oral, regardless of whether the advice is standardized, or is based on, or tailored to, the commodity interest or cash market positions or other circumstances or characteristics of the particular consumer; (E) You are a commodity pool operator, and you accept or receive from the consumer, funds, securities, or property for the purpose of purchasing an interest in a commodity pool; (F) You hold securities or other assets as collateral for a loan made to the consumer, even if you did not make the loan or do not effect any transactions on behalf of the consumer; or (G) You regularly effect or engage in commodity interest transactions with or for a consumer even if you do not hold any assets of the consumer. (ii) No continuing relationship. A consumer does not have a continuing relationship with you if: (A) You have acted solely as a “finder” for a futures commission merchant, and you do not solicit or accept specific orders for trades; or (B) You have solicited the consumer to participate in a pool or to direct his or her account and he or she has not provided you with funds to participate in a pool or entered into any agreement for you to direct his or her account. (m) Federal functional regulator means: (1) The Board of Governors of the Federal Reserve System; (2) The Office of the Comptroller of the Currency; (3) The Board of Directors of the Federal Deposit Insurance Corporation; (4) The Director of the Office of Thrift Supervision; (5) The National Credit Union Administration Board; (6) The Securities and Exchange Commission; and (7) The Commodity Futures Trading Commission. (n)(1) Financial institution means: (i) Any futures commission merchant, retail foreign exchange dealer, commodity trading advisor, commodity pool operator, introducing broker, major swap participant, or swap dealer that is registered with the Commission as such or is otherwise subject to the Commission's jurisdiction; and (2) Financial institution does not include: (i) Any person or entity, other than a futures commission merchant, retail foreign exchange dealer, commodity trading advisor, commodity pool operator, introducing broker, major swap participant, or swap dealer that, with respect to any financial activity, is subject to the jurisdiction of the Commission under the Act. (ii) The Federal Agricultural Mortgage Corporation or any entity chartered and operating under the Farm Credit Act of 1971 (12 U.S.C. 2001 et seq. ); or (iii) Institutions chartered by Congress specifically to engage in securitizations, secondary market sales (including sales of servicing rights) or similar transactions related to a transaction of a consumer, as long as such institutions do not sell or transfer nonpublic personal information to a nonaffiliated third party. (o)(1) Financial product or service means: (i) Any product or service that a futures commission merchant, retail foreign exchange dealer, commodity trading advisor, commodity pool operator, introducing broker, major swap participant, or swap dealer could offer that is subject to the Commission's jurisdiction; and (ii) Any product or service that any other financial institution could offer by engaging in an activity that is financial in nature or incidental to such a financial activity under section 4(k) of the Bank Holding Company Act of 1956, 12 U.S.C. 1843(k). (2) Financial service includes your evaluation or brokerage of information that you collect in connection with a request or an application from a consumer for a financial product or service. (p) Futures commission merchant has the same meaning as in section 1a(20) of the Commodity Exchange Act, as amended, and includes any person registered as such under the Act. (q) GLB Act means the Gramm-Leach-Bliley Act (Pub. L. No. 106-102, 113 Stat. 1338 (1999)). (r) Introducing broker has the same meaning as in section 1a(23) of the Commodity Exchange Act, as amended, and includes any person registered as such under the Act. (s) Major swap participant. The term “major swap participant” has the same meaning as in section 1a(33) of the Commodity Exchange Act, 7 U.S.C. 1 et seq., as may be further defined by this title, and includes any person registered as such thereunder. (t)(1) Nonaffiliated third party means any person except: (i) Your affiliate; or (ii) A person employed jointly by you and any company that is not your affiliate, but nonaffiliated third party includes the other company that jointly employs the person. (2) Nonaffiliated third party includes any company that is an affiliate solely by virtue of your or your affiliate's direct or indirect ownership or control of the company in conducting merchant banking or investment banking activities of the type described in section 4(k)(4)(H) or insurance company investment activities of the type described in section 4(k)(4)(I) of the Bank Holding Company Act of 1956, 12 U.S.C. 1843(k)(4)(H) and (I). (u)(1) Nonpublic personal information means: (i) Personally identifiable financial information; and (ii) Any list, description or other grouping of consumers, and publicly available information pertaining to them, that is derived using any personally identifiable financial information that is not publicly available information. (2) Nonpublic personal information does not include: (i) Publicly available information, except as included on a list described in paragraph (t)(1)(ii) of this section or when the publicly available information is disclosed in a manner that indicates the individual is or has been your consumer; or (ii) Any list, description or other grouping of consumers, and publicly available information pertaining to them, that is derived without using any personally identifiable financial information that is not publicly available information. (3) Examples of lists. (i) Nonpublic personal information includes any list of individuals' names and street addresses that is derived in whole or in part using personally identifiable financial information that is not publicly available information, such as account numbers. (ii) Nonpublic personal information does not include any list of individuals' names and addresses that contains only publicly available information, is not derived in whole or in part using personally identifiable financial information that is not publicly available information, and is not disclosed in a manner that indicates that any of the individuals on the list is a consumer of a financial institution. (v)(1) Personally identifiable financial information means any information: (i) A consumer provides to you to obtain a financial product or service from you; (ii) About a consumer resulting from any transaction involving a financial product or service between you and a consumer; or (iii) You otherwise obtain about a consumer in connection with providing a financial product or service to that consumer. (2) Examples —(i) Information included. Personally identifiable financial information includes: (A) Information a consumer provides to you on an application to open a commodity interest trading account, to invest in a commodity pool, or to obtain another financial product or service; (B) Account balance information, payment history, overdraft history, margin call history, trading history, and credit or debit card purchase information; (C) The fact that an individual is or has been one of your customers or has obtained a financial product or service from you; (D) Any information about your consumer if it is disclosed in a manner that indicates that the individual is or has been your consumer; (E) Any information you collect through an Internet “cookie” (an information-collecting device from a web server); and (F) Information from a consumer report. (ii) Information not included. Personally identifiable financial information does not include: (A) A list of names and addresses of customers of an entity that is not a financial institution; or (B) Information that does not identify a consumer, such as aggregate information or blind data that does not contain personal identifiers such as account numbers, names or addresses. (w)(1) Publicly available information means any information that you reasonably believe is lawfully made available to the general public from: (i) Federal, state or local government records; (ii) Widely distributed media; or (iii) Disclosures to the general public that are required to be made by federal, state or local law. (2) Examples —(i) Reasonable belief. (A) You have a reasonable belief that information about your consumer is made available to the general public if you have confirmed, or your consumer has represented to you, that the information is publicly available from a source described in paragraphs (v)(1)(i)-(iii) of this section. (B) You have a reasonable belief that information about your consumer is made available to the general public if you have taken steps to submit the information, in accordance with your internal procedures and policies and with applicable law, to a keeper of federal, state or local government records that is required by law to make the information publicly available. (C) You have a reasonable belief that an individual's telephone number is lawfully made available to the general public if you have located the telephone number in the telephone book or on an internet listing service, or the consumer has informed you that the telephone number is not unlisted. (D) You do not have a reasonable belief that information about a consumer is publicly available solely because that information would normally be recorded with a keeper of federal, state or local government records that is required by law to make the information publicly available, if the consumer has the ability in accordance with applicable law to keep that information nonpublic, such as where a consumer may record a deed in the name of a blind trust. (ii) Government records. Publicly available information in government records includes information in government real estate records and security interest filings. (iii) Widely distributed media. Publicly available information from widely distributed media includes information from a telephone book, a television or radio program, a newspaper, or a web site that is available to the general public on an unrestricted basis. A web site is not restricted merely because an Internet service provider or a site operator requires a fee or password, so long as access is available to the general public. (x) Swap dealer. The term “swap dealer” has the same meaning as in section 1a(49) of the Commodity Exchange Act, 7 U.S.C. 1 et seq., as may be further defined by this title, and includes any person registered as such thereunder. (y) You means: (1) Any futures commission merchant; (2) Any retail foreign exchange dealer; (3) Any commodity trading advisor; (4) Any commodity pool operator; (5) Any introducing broker; (6) Any major swap participant; and (7) Any swap dealer. (z) Retail foreign exchange dealer has the same meaning as in § 5.3(i)(1) of this chapter." 17:17:2.0.1.1.26.1.1.1,17,Commodity and Securities Exchanges,I,,160,PART 160—PRIVACY OF CONSUMER FINANCIAL INFORMATION UNDER TITLE V OF THE GRAMM-LEACH-BLILEY ACT,A,Subpart A—Privacy and Opt Out Notices,,§ 160.4 Initial privacy notice to consumers required.,CFTC,,,"[66 FR 21252, Apr. 27, 2001, as amended at 75 FR 55451, Sept. 10, 2010]","(a) Initial notice requirement. You must provide a clear and conspicuous notice that accurately reflects your privacy policies and practices to: (1) Customer. An individual who becomes your customer, not later than when you establish a customer relationship, except as provided in paragraph (e) of this section; and (2) Consumer. A consumer, before you disclose any nonpublic personal information about the consumer to any nonaffiliated third party, if you make such a disclosure other than as authorized by §§ 160.14 and 160.15. (b) When initial notice to a consumer is not required. You are not required to provide an initial notice to a consumer under paragraph (a) of this section if: (1) You do not disclose any nonpublic personal information about the consumer to any nonaffiliated third party other than as authorized by §§ 160.14 and 160.15; and (2) You do not have a customer relationship with the consumer. (c) When you establish a customer relationship —(1) General rule. You establish a customer relationship when you and the consumer enter into a continuing relationship. (2) Examples of establishing customer relationship. You establish a customer relationship when the consumer: (i) Instructs you to execute a commodity interest transaction for the consumer; (ii) Opens a retail forex account, or opens a commodity interest account through an introducing broker or with a futures commission merchant that clears transactions for its customers through you on a fully-disclosed basis; (iii) Transmits specific orders for commodity interest transactions to you that you pass on to a futures commission merchant for execution, if you are an introducing broker; (iv) Enters into an advisory contract or subscription with you, whether in writing or orally, and whether you provide standardized, or individually tailored commodity trading advice based on the customer's commodity interest or cash market positions or other circumstances or characteristics, if you are a commodity trading adviser; or (v) Provides to you funds, securities, or property for an interest in a commodity pool, if you are a commodity pool operator. (d) Existing customers. When an existing customer obtains a new financial product or service from you that is to be used primarily for personal, family or household purposes, you satisfy the initial notice requirements of paragraph (a) of this section as follows: (1) You may provide a revised privacy notice under § 160.8 that covers the customer's new financial product or service; or (2) If the initial, revised or annual notice that you most recently provided to that customer was accurate with respect to the new financial product or service, you do not need to provide a new privacy notice under paragraph (a) of this section. (e) Exceptions to allow subsequent delivery of notice. (1) You may provide the initial notice required by paragraph (a)(1) of this section within a reasonable time after you establish a customer relationship if: (i) Establishing the customer relationship is not at the customer's election; (ii) Providing notice not later than when you establish a customer relationship would substantially delay the customer's transaction and the customer agrees to receive the notice at a later time; (iii) A nonaffiliated financial institution establishes a customer relationship between you and a consumer without your prior knowledge; or (iv) You have established a customer relationship with a customer in a bulk transfer in accordance with § 1.65, if you are a transferee futures commission merchant, retail foreign exchange dealer or introducing broker. (2) Examples of exceptions —(i) Not at customer's election. Establishing a customer relationship is not at the customer's election if you acquire the customer's commodity interest account from another financial institution and the customer does not have a choice about your acquisition. (ii) Substantial delay of customer's transaction. Providing notice not later than when you establish a customer relationship would substantially delay the customer's transaction when you and the individual agree over the telephone to enter into a customer relationship involving prompt delivery of the financial product or service. (iii) No substantial delay of customer's transaction. Providing notice not later than when you establish a customer relationship would not substantially delay the customer's transaction when the relationship is initiated in person at your office or through other means by which the customer may view the notice, such as on a web site. (f) Delivery of notice. When you are required by this section to deliver an initial privacy notice, you must deliver it according to the provisions of § 160.9. If you use a short-form initial notice for non-customers according to § 160.6(d), you may deliver your privacy notice as provided in section § 160.6(d)(3)." 17:17:2.0.1.1.26.1.1.2,17,Commodity and Securities Exchanges,I,,160,PART 160—PRIVACY OF CONSUMER FINANCIAL INFORMATION UNDER TITLE V OF THE GRAMM-LEACH-BLILEY ACT,A,Subpart A—Privacy and Opt Out Notices,,§ 160.5 Annual privacy notice to customers required.,CFTC,,,"[66 FR 21252, Apr. 27, 2001, as amended at 84 FR 17345, Apr. 25, 2019]","(a)(1) General rule. Except as provided by paragraph (d) of this section, you must provide a clear and conspicuous notice to customers that accurately reflects your privacy policies and practices not less than annually during the life of the customer relationship. Annually means at least once in any period of 12 consecutive months during which that relationship exists. You may define the 12-consecutive-month period, but you must apply it to the customer on a consistent basis. (2) Example. You provide notice annually if you define the 12-consecutive-month period as a calendar year and provide the annual notice to the customer once in each calendar year following the calendar year in which you provided the initial notice. For example, if a customer opens an account on any day of year 1, you must provide an annual notice to that customer by December 31 of year 2. (b)(1) Termination of customer relationship. You are not required to provide an annual notice to a former customer. (2) Examples. Your customer becomes a former customer when: (i) The individual's commodity interest account is closed; (ii) The individual's advisory contract or subscription is terminated or expires; or (iii) The individual has redeemed all of his or her units in your pool. (c) Delivery of notice. When you are required by this section to deliver an annual privacy notice, you must deliver it in the manner provided by § 160.9. (d) Exception to annual privacy notice requirement. (1) You are not required to deliver an annual privacy notice if you: (i) Provide nonpublic personal information to nonaffiliated third parties only in accordance with the provisions of §§ 160.13, 160.14, and 160.15 and any other exceptions adopted by the Commission pursuant to section 504(b) of the GLB Act; and (ii) Have not changed your policies and practices with regard to disclosing nonpublic personal information from the policies and practices that were disclosed to the customer under § 160.6(a)(2) through (5) and § 160.6(a)(9) in the most recent privacy notice sent to the customer pursuant to this part. (2) Delivery of annual privacy notice after you no longer meet requirements for exception. If you have been excepted from delivering an annual privacy notice pursuant to paragraph (d)(1) of this section and change your policies or practices in such a way that you no longer meet the requirements for that exception, you must comply with paragraph (d)(2)(i) or (ii) of this section, as applicable. (i) Changes preceded by a revised privacy notice. If you no longer meet the requirements of paragraph (d)(1) of this section because you change your policies or practices in such a way that § 160.8 of this part requires you to provide a revised privacy notice, you must provide an annual privacy notice in accordance with the timing requirements in paragraph (a) of this section, treating the revised privacy notice as an initial privacy notice. (ii) Changes not preceded by a revised privacy notice. If you no longer meet the requirements of paragraph (d)(1) of this section because you change your policies or practices in such a way that § 160.8 of this part does not require you to provide a revised privacy notice, you must provide an annual privacy notice within 100 days of the change in your policies or practices that causes you to no longer meet the requirements of paragraph (d)(1) of this section." 17:17:2.0.1.1.26.1.1.3,17,Commodity and Securities Exchanges,I,,160,PART 160—PRIVACY OF CONSUMER FINANCIAL INFORMATION UNDER TITLE V OF THE GRAMM-LEACH-BLILEY ACT,A,Subpart A—Privacy and Opt Out Notices,,§ 160.6 Information to be included in privacy notices.,CFTC,,,"[66 FR 21252, Apr. 27, 2001, as amended at 74 FR 62974, Dec. 1, 2009]","(a) General rule. The initial, annual, and revised privacy notices that you provide under §§ 160.4, 160.5 and 160.8 must include each of the following items of information that applies to you or to the consumers to whom you send your privacy notice, in addition to any other information you wish to provide: (1) The categories of nonpublic personal information that you collect; (2) The categories of nonpublic personal information that you disclose; (3) The categories of affiliates and nonaffiliated third parties to whom you disclose nonpublic personal information, other than those parties to whom you disclose information under §§ 160.14 and 160.15; (4) The categories of nonpublic personal information about your former customers that you disclose and the categories of affiliates and nonaffiliated third parties to whom you disclose nonpublic personal information about your former customers, other than those parties to whom you disclose information under §§ 160.14 and 160.15; (5) If you disclose nonpublic personal information to a nonaffiliated third party under § 160.13 (and no other exception applies to that disclosure), a separate statement of the categories of information you disclose and the categories of third parties with whom you have contracted; (6) An explanation of the consumer's rights under § 160.10(a) to opt out of the disclosure of nonpublic personal information to nonaffiliated third parties, including the method(s) by which the consumer may exercise that right at that time; (7) Any disclosures that you make under § 603(d)(2)(A)(iii) of the Fair Credit Reporting Act (15 U.S.C. 1681a(d)(2)(A)(iii)) (that is, notices regarding the ability to opt out of disclosures of information among affiliates); (8) Your policies and practices with respect to protecting the confidentiality and security of nonpublic personal information; and (9) Any disclosure that you make under paragraph (b) of this section. (b) Description of nonaffiliated third parties subject to exceptions. If you disclose nonpublic personal information to third parties as authorized under §§ 160.14 and 160.15, you are not required to list those exceptions in the initial or annual privacy notices required by §§ 160.4 and 160.5. When describing the categories with respect to those parties, it is sufficient to state that you make disclosures to other nonaffiliated companies: (1) For your everyday business purposes, such as [include all that apply] to process transactions, maintain account(s), respond to court orders and legal investigations, or report to credit bureaus; or (2) As permitted by law. (c) Examples —(1) Categories of nonpublic personal information that you collect. You satisfy the requirement to categorize the nonpublic personal information that you collect if you list the following categories, as applicable: (i) Information from the consumer; (ii) Information about the consumer's transactions with you or your affiliates; (iii) Information about the consumer's transactions with nonaffiliated third parties; and (iv) Information from a consumer reporting agency. (2) Categories of nonpublic personal information you disclose. (i) You satisfy the requirement to categorize the nonpublic personal information you disclose if you list the categories described in paragraph (e)(1) of this section, as applicable, and a few examples to illustrate the types of information in each category. (ii) If you reserve the right to disclose all of the nonpublic personal information about consumers that you collect, you may simply state that fact without describing the categories or examples of the nonpublic personal information you disclose. (3) Categories of affiliates and nonaffiliated third parties to whom you disclose. You satisfy the requirement to categorize the affiliates and nonaffiliated third parties to whom you disclose nonpublic personal information if you list the following categories, as applicable, and a few examples to illustrate the types of third parties in each category: (i) Financial service providers; (ii) Non-financial companies; and (iii) Others. (4) Disclosures under exception for service providers and joint marketers. If you disclose nonpublic personal information under the exception in § 160.13 to a nonaffiliated third party to market products or services that you offer alone or jointly with another financial institution, you satisfy the disclosure requirement of paragraph (a)(5) of this section if you: (i) List the categories of nonpublic personal information you disclose, using the same categories and examples you used to meet the requirements of paragraph (a)(2) of this section, as applicable; and (ii) State whether the third party is: (A) A service provider that performs marketing services on your behalf or on behalf of you and another financial institution; or (B) A financial institution with which you have a joint marketing agreement. (5) Simplified notices. If you do not disclose, and do not wish to reserve the right to disclose, nonpublic personal information to affiliates or nonaffiliated third parties except as authorized under §§ 160.14 and 160.15, you may simply state that fact, in addition to information you must provide under paragraphs (a)(1), (a)(8), (a)(9) and (b) of this section. (6) Confidentiality and security. You describe your policies and practices with respect to protecting the confidentiality and security of nonpublic personal information if you do both of the following: (i) Describe in general terms who is authorized to have access to the information; and (ii) State whether you have security practices and procedures in place to ensure the confidentiality of the information in accordance with your policy. You are not required to describe technical information about the safeguards you use. (d) Short-form initial notice with opt out notice for non-customers. (1) You may satisfy the initial notice requirements in §§ 160.4(a)(2), 160.7(b) and 160.7(c) for a consumer who is not a customer by providing a short-form initial notice at the same time as you deliver an opt out notice as required in 160.7. (2) A short-form initial notice must: (i) Be clear and conspicuous; (ii) State that your privacy notice is available upon request; and (iii) Explain a reasonable means by which the consumer may obtain your privacy notice. (3) You must deliver your short-form initial notice according to § 160.9. You are not required to deliver your privacy notice with your short-form initial notice. You instead may simply provide the consumer a reasonable means to obtain your privacy notice. If a consumer who receives your short-form notice requests your privacy notice, you must deliver your privacy notice according to § 160.9. (4) Examples of obtaining privacy notice. You provide a reasonable means by which a consumer may obtain a copy of your privacy notice if you: (i) Provide a toll-free telephone number that the consumer may call to request the notice; or (ii) For a consumer who conducts business in person at your office, maintain copies of the notice on hand that you provide to the consumer immediately upon request. (e) Future disclosures. Your notice may include: (1) Categories of nonpublic personal information that you reserve the right to disclose in the future, but do not currently disclose; and (2) Categories of affiliates and nonaffiliated third parties to whom you reserve the right in the future to disclose, but to whom you do not currently disclose, nonpublic personal information. (f) Model privacy form. Pursuant to § 160.2(a) of this part, a model privacy form that meets the notice content requirements of this section is included in appendix A of this part." 17:17:2.0.1.1.26.1.1.4,17,Commodity and Securities Exchanges,I,,160,PART 160—PRIVACY OF CONSUMER FINANCIAL INFORMATION UNDER TITLE V OF THE GRAMM-LEACH-BLILEY ACT,A,Subpart A—Privacy and Opt Out Notices,,§ 160.7 Form of opt out notice to consumers; opt out methods.,CFTC,,,"[66 FR 21252, Apr. 27, 2001, as amended at 74 FR 62974, Dec. 1, 2009]","(a)(1) Form of opt out notice. If you are required to provide an opt out notice under § 160.10(a), you must provide a clear and conspicuous notice to each of your consumers that accurately explains the right to opt out under that section. The notice must state: (i) That you disclose or reserve the right to disclose nonpublic personal information about your consumer to a nonaffiliated third party; (ii) That the consumer has the right to opt out of that disclosure; and (iii) A reasonable means by which the consumer may exercise the opt out right. (2) Examples —(i) Adequate opt out notice. You provide adequate notice that the consumer can opt out of the disclosure of nonpublic personal information to a nonaffiliated third party if you: (A) Identify all of the categories of nonpublic personal information that you disclose or reserve the right to disclose, and all of the categories of nonaffiliated third parties to which you disclose the information, as described in § 160.6(a)(2) and (3), and state that the consumer can opt out of the disclosure of that information; and (B) Identify the financial products or services that the consumer obtains from you, either singly or jointly, to which the opt out direction would apply. (ii) Reasonable means to opt out. You provide a reasonable means to exercise an opt out right if you: (A) Designate check-off boxes in a prominent position on the relevant forms with the opt out notice; (B) Include a reply form together with the opt out notice; (C) Provide an electronic means to opt out, such as a form that can be sent via electronic mail or a process at your web site, if the consumer agrees to the electronic delivery of information; or (D) Provide a toll-free telephone number that consumers may call to opt out. (iii) Unreasonable opt out means. You do not provide a reasonable means of opting out if: (A) The only means of opting out is for the consumer to write his or her own letter to exercise that opt out right; or (B) The only means of opting out as described in any notice subsequent to the initial notice is to use a check-off box that you provided with the initial notice but did not include with the subsequent notice. (iv) Specific opt out means. You may require each consumer to opt out through a specific means, as long as that means is reasonable for the consumer. (b) Same form as initial notice permitted. You may provide the opt out notice together with or on the same written or electronic form, as the initial notice you provide in accordance with § 160.4. (c) Initial notice required when opt out notice delivered subsequent to initial notice. If you provide the opt out notice after the initial notice in accordance with § 160.4, you must also include a copy of the initial notice with the opt out notice in writing, or, if the consumer agrees, electronically. (d) Joint relationships. (1) If two or more consumers jointly obtain a financial product or service from you, you may provide a single opt out notice; however, you must honor a request from one or more joint account holders for a separate opt out notice. Your opt out notice must explain how you will treat an opt out direction by a joint consumer. (2) Any of the joint consumers may exercise the right to opt out. You may either: (i) Treat an opt out direction by a joint consumer as applying to all of the associated joint consumers; or (ii) Permit each joint consumer to opt out separately. (3) If you permit each joint consumer to opt out separately, you must permit one of the joint consumers to opt out on behalf of all of the joint consumers. (4) You may not require all joint consumers to opt out before you implement any opt out direction. (5) Example. If John and Mary have a joint trading account with you and arrange for you to send statements to John's address, you may do any of the following, but you must explain in your opt out notice which opt out policy you will follow: (i) Send a single opt out notice to John's address, but you must accept an opt out direction from either John or Mary; (ii) Treat an opt out direction by either John or Mary as applying to the entire account. If you do so, and John opts out, you may not require Mary to opt out as well before implementing John's opt out direction; or (iii) Permit John and Mary to make different opt out directions. If you do so: (A) You must permit John and Mary to opt out for each other. (B) If both opt out, you must permit both to notify you in a single response (such as on a form or through a telephone call). (C) If John opts out and Mary does not, you may only disclose nonpublic personal information about Mary, but not about John, and not about John and Mary jointly. (e) Time to comply with opt out. You must comply with a consumer's opt out direction as soon as reasonably practicable after you receive it. (f) Continuing right to opt out. A consumer may exercise the right to opt out at any time. (g) Duration of consumer's opt out direction. (1) A consumer's direction to opt out under this section is effective until the consumer revokes it in writing, either by hard copy or, if the consumer agrees, electronically. (2) When a customer relationship terminates, the customer's opt out direction continues to apply to the nonpublic personal information that you collected during or related to that relationship. If the individual subsequently establishes a new customer relationship with you, the opt out direction that applied to the former relationship does not apply to the new relationship. (h) Delivery. When you are required by this section to deliver an opt out notice, you must deliver it according to § 160.9. (i) Model privacy form. Pursuant to § 160.2(a) of this part, a model privacy form that meets the notice content requirements of this section is included in appendix A of this part." 17:17:2.0.1.1.26.1.1.5,17,Commodity and Securities Exchanges,I,,160,PART 160—PRIVACY OF CONSUMER FINANCIAL INFORMATION UNDER TITLE V OF THE GRAMM-LEACH-BLILEY ACT,A,Subpart A—Privacy and Opt Out Notices,,§ 160.8 Revised privacy notices.,CFTC,,,,"(a) General rule. Except as otherwise authorized in this part, you must not, directly or through any affiliate, disclose any nonpublic personal information about a consumer to a nonaffiliated third party other than as described in the initial notice that you provided to that consumer under § 160.4, unless: (1) You have provided to the consumer a clear and conspicuous revised notice that accurately describes your policies and practices; (2) You have provided to the consumer a new opt out notice; (3) You have given the consumer a reasonable opportunity, before you disclose the information to the nonaffiliated third party, to opt out of the disclosure; and (4) The consumer does not opt out. (b) Examples. (1) Except as otherwise permitted by §§ 160.13, 160.14, and 160.15, you must provide a revised notice before you: (i) Disclose a new category of nonpublic personal information to any nonaffiliated third party; (ii) Disclose nonpublic personal information to a new category of nonaffiliated third party; or (iii) Disclose nonpublic personal information about a former customer to a nonaffiliated third party, if that former customer has not had the opportunity to exercise an opt out right regarding that disclosure. (2) A revised notice is not required if you disclose nonpublic personal information to a new nonaffiliated third party that you adequately described in your prior notice. (c) Delivery. When you are required to deliver a revised privacy notice by this section, you must deliver it according to § 160.9." 17:17:2.0.1.1.26.1.1.6,17,Commodity and Securities Exchanges,I,,160,PART 160—PRIVACY OF CONSUMER FINANCIAL INFORMATION UNDER TITLE V OF THE GRAMM-LEACH-BLILEY ACT,A,Subpart A—Privacy and Opt Out Notices,,§ 160.9 Delivering privacy and opt out notices.,CFTC,,,,"(a) How to provide notices. You must provide any privacy notices and opt out notices, including short-form initial notices that this part requires so that each consumer can reasonably be expected to receive actual notice in writing either in hard copy or, if the consumer agrees, electronically. (b)(1) Examples of reasonable expectation of actual notice. You may reasonably expect that a consumer will receive actual notice if you: (i) Hand-deliver a printed copy of the notice to the consumer; (ii) Mail a printed copy of the notice to the last known address of the consumer; or (iii) For the consumer who conducts transactions electronically, post the notice on the electronic site and require the consumer to acknowledge receipt of the notice as a necessary step to obtaining a particular financial service or product. (2) Examples of unreasonable expectation of actual notice. You may not, however, reasonably expect that a consumer will receive actual notice of your privacy policies and practices if you: (i) Only post a sign in your branch or office or generally publish advertisements of your privacy policies and practices; or (ii) Send the notice via electronic mail to a consumer who does not obtain a financial product or service from you electronically. (c) Annual notices only. You may reasonably expect that a consumer will receive actual notice of your annual privacy notice if: (1) The customer uses your web site to access financial products and services electronically and agrees to receive notices at the web site and you post your current privacy notice continuously in a clear and conspicuous manner on the web site; or (2) The customer has requested that you refrain from sending any information regarding the customer relationship, and your current privacy notice remains available to the customer upon request. (d) Oral description of notice insufficient. You may not provide any notice required by this part solely by orally explaining the notice, either in person or over the telephone. (e) Retention or accessibility of notices for customers. (1) For customers only, you must provide the initial notice required by § 160.4(a)(1), the annual notice required by § 160.5(a), and the revised notice required by § 160.8, so that the customer can retain them or obtain them later in writing or, if the customer agrees, electronically. (2) Examples of retention or accessibility. You provide a privacy notice to the customer so that the customer can retain it or obtain it later if you: (i) Hand-deliver a printed copy of the notice to the customer; (ii) Mail a printed copy of the notice to the last known address of the customer; or (iii) Make your current privacy notice available on a web site (or a link to another web site) for the customer who obtains a financial product or service electronically and agrees to receive the notice at the web site. (f) Joint notice with other financial institutions. You may provide a joint notice from you and one or more of your affiliates or other financial institutions, as identified in the notice, as long as the notice is accurate with respect to you and the other institutions. (g) Joint relationships. If two or more customers jointly obtain a financial product or service from you, you may satisfy the initial, annual, and revised notice requirements of paragraph (a) of this section by providing one notice to those customers jointly; however, you must honor a request by one or more joint account holders for a separate notice." 17:17:2.0.1.1.26.2.1.1,17,Commodity and Securities Exchanges,I,,160,PART 160—PRIVACY OF CONSUMER FINANCIAL INFORMATION UNDER TITLE V OF THE GRAMM-LEACH-BLILEY ACT,B,Subpart B—Limits on Disclosures,,§ 160.10 Limits on disclosure of nonpublic personal information to nonaffiliated third parties.,CFTC,,,,"(a)(1) Conditions for disclosure. Except as otherwise authorized in this part, you may not, directly or through any affiliate, disclose any nonpublic personal information about a consumer to a nonaffiliated third party unless: (i) You have provided to the consumer an initial notice as required under § 160.4; (ii) You have provided to the consumer an opt out notice as required in § 160.7; (iii) You have given the consumer a reasonable opportunity, before you disclose the information to the nonaffiliated third party, to opt of the disclosure; and (iv) The consumer does not opt out. (2) Opt out definition. Opt out means a direction by the consumer that you not disclose nonpublic personal information about that consumer to a nonaffiliated third party, other than as permitted by §§ 160.13, 160.14 and 160.15. (3) Examples of reasonable opportunity to opt out. You provide a consumer with a reasonable opportunity to opt out if: (i) By mail. You mail the notices required in paragraph (a)(1) of this section to the consumer and allow the consumer to opt out by mailing a form, calling a toll-free telephone number, or any other reasonable means within 30 days after the date you mailed the notices. (ii) By electronic means. A customer opens an on-line account with you and agrees to receive the notices required in paragraph (a)(1) of this section electronically, and you allow the customer to opt out by any reasonable means within 30 days after the date that the customer acknowledges receipt of the notices in conjunction with opening the account. (iii) Isolated transaction with consumer. For an isolated transaction with a consumer, you provide the consumer with a reasonable opportunity to opt out if you provide the notices required in paragraph (a)(1) of this section at the time of the transaction and request that the consumer decide, as a necessary part of the transaction, whether to opt out before completing the transaction. (b) Application of opt out to all consumers and all nonpublic personal information. (1) You must comply with this section, regardless of whether you and the consumer have established a customer relationship. (2) Unless you comply with this section, you may not, directly or through any affiliate, disclose any nonpublic personal information about a consumer that you have collected, regardless of whether you have collected it before or after receiving the direction to opt out from the consumer. (c) Partial opt out. You may allow a consumer to select certain nonpublic personal information or certain nonaffiliated third parties with respect to which the consumer wishes to opt out." 17:17:2.0.1.1.26.2.1.2,17,Commodity and Securities Exchanges,I,,160,PART 160—PRIVACY OF CONSUMER FINANCIAL INFORMATION UNDER TITLE V OF THE GRAMM-LEACH-BLILEY ACT,B,Subpart B—Limits on Disclosures,,§ 160.11 Limits on redisclosure and reuse of information.,CFTC,,,,"(a) (1) Information you receive under an exception. If you receive nonpublic personal information from a nonaffiliated financial institution under an exception in § 160.14 or § 160.15, your disclosure and use of that information is limited as follows: (i) You may disclose the information to the affiliate of the financial institution from which you received the information; (ii) You may disclose the information to your affiliates, but your affiliates may, in turn, disclose and use the information only to the extent that you may disclose and use the information; and (iii) You may disclose and use the information pursuant to an exception in § 160.14 or § 160.15 in the ordinary course of business to carry out the activity covered by the exception under which you received the information. (2) Example. If you receive a customer list from a nonaffiliated financial institution in order to provide account-processing services under the exception in § 160.14(a), you may disclose that information under any exception in § 160.14 or § 160.15 in the ordinary course of business in order to provide those services. For example, you could disclose that information in response to a properly authorized subpoena or in the ordinary course of business to your attorneys, accountants, and auditors. You could not disclose that information to a third party for marketing purposes or use that information for your own marketing purposes. (b)(1) Information you receive outside of an exception. If you receive nonpublic personal information from a nonaffiliated financial institution other than under an exception in § 160.14 or § 160.15, you may disclose the information only: (i) To the affiliates of the financial institution from which you received the information; (ii) To your affiliates, but your affiliates may, in turn, disclose the information only to the extent that you can disclose the information; and (iii) To any other person, if the disclosure would be lawful if made directly to that person by the financial institution from which you received the information. (2) Example. If you obtain a customer list from a nonaffiliated financial institution outside of the exceptions in §§ 160.14 and 160.15: (i) You may use that list for your own purposes; (ii) You may disclose that list to another nonaffiliated third party only if the financial institution from which you purchased the list could have lawfully disclosed that list to that third party. That is, you may disclose the list in accordance with the privacy policy of the financial institution from which you received the list as limited by the opt out direction of each consumer whose nonpublic personal information you intend to disclose, and you may disclose the list in accordance with an exception in §§ 160.14 and 160.15, such as in the ordinary course of business to your attorneys, accountants, or auditors. (c) Information you disclose under an exception. If you disclose nonpublic personal information to a nonaffiliated third party under an exception in § 160.14 or § 160.15, the third party may disclose and use that information only as follows: (1) The third party may disclose the information to your affiliates; (2) The third party may disclose the information to its affiliates, but its affiliates may, in turn, disclose and use the information only to the extent that the third party may disclose and use the information; and (3) The third party may disclose and use the information pursuant to an exception in § 160.14 or § 160.15 in the ordinary course of business to carry out the activity covered by the exception under which it received the information. (d) Information you disclose outside of an exception. If you disclose nonpublic personal information to a nonaffiliated third party other than under an exception in § 160.14 or § 160.15, the third party may disclose the information only: (1) To your affiliates; (2) To its affiliates, but its affiliates, in turn, may disclose the information only to the extent the third party can disclose the information; and (3) To any other person, if the disclosure would be lawful if you made it directly to that person." 17:17:2.0.1.1.26.2.1.3,17,Commodity and Securities Exchanges,I,,160,PART 160—PRIVACY OF CONSUMER FINANCIAL INFORMATION UNDER TITLE V OF THE GRAMM-LEACH-BLILEY ACT,B,Subpart B—Limits on Disclosures,,§ 160.12 Limits on sharing account number information for marketing purposes.,CFTC,,,,"(a) General prohibition on disclosure of account numbers. You must not, directly or through an affiliate, disclose, other than to a consumer reporting agency, an account number or similar form of access number or access code for a consumer's credit card account, deposit account or transaction account to any nonaffiliated third party for use in telemarketing, direct mail marketing or other marketing through electronic mail to the consumer. (b) Exceptions. Paragraph (a) of this section does not apply if you disclose an account number or similar form of access number or access code: (1) To your agent or service provider solely in order to perform marketing for your own services or products, as long as the agent or service provider is not authorized to directly initiate charges to the account; or (2) To a participant in a private-label credit card program or an affinity or similar program where the participants in the program are identified to the customer when the customer enters into the program. (c) Example. An account number, or similar form of access number or access code, does not include a number or code in an encrypted form, as long as you do not provide the recipient with a means to decode the number or code." 17:17:2.0.1.1.26.3.1.1,17,Commodity and Securities Exchanges,I,,160,PART 160—PRIVACY OF CONSUMER FINANCIAL INFORMATION UNDER TITLE V OF THE GRAMM-LEACH-BLILEY ACT,C,Subpart C—Exceptions,,§ 160.13 Exception to opt out requirements for service providers and joint marketing.,CFTC,,,,"(a) General rule. (1) The opt out requirements in §§ 160.7 and 160.10 do not apply when you provide nonpublic personal information to a nonaffiliated third party to perform services for you or functions on your behalf if you: (i) Provide the initial notice in accordance with § 160.4; and (ii) Enter into a contractual agreement with the third party that prohibits the third party from disclosing or using the information other than to carry out the purposes for which you disclosed the information, including use under an exception in § 160.14 or § 160.15 in the ordinary course of business to carry out those purposes. (2) Example. If you disclose nonpublic personal information under this section to a financial institution with which you perform joint marketing, your contractual agreement with that institution meets the requirements of paragraph (a)(1)(ii) of this section if it prohibits the institution from disclosing or using the nonpublic personal information except as necessary to carry out the joint marketing or under an exception in § 160.14 or § 160.15 in the ordinary course of business to carry out that joint marketing. (b) Service may include joint marketing. The services a nonaffiliated third party performs for you under paragraph (a) of this section may include marketing of your own products or services or marketing of financial products or services offered pursuant to joint agreements between you and one or more financial institutions. (c) Definition of joint agreement. For purposes of this section, joint agreement means a written contract pursuant to which you and one or more financial institutions jointly offer, endorse or sponsor a financial product or service." 17:17:2.0.1.1.26.3.1.2,17,Commodity and Securities Exchanges,I,,160,PART 160—PRIVACY OF CONSUMER FINANCIAL INFORMATION UNDER TITLE V OF THE GRAMM-LEACH-BLILEY ACT,C,Subpart C—Exceptions,,§ 160.14 Exceptions to notice and opt out requirements for processing and servicing transactions.,CFTC,,,,"(a) Exceptions for processing and servicing transactions at consumer's request. The requirements for initial notice in § 160.4(a)(2), for the opt out in §§ 160.7 and 160.10, and for initial notice in § 160.13 in connection with service providers and joint marketing, do not apply if you disclose nonpublic personal information as necessary to effect, administer, or enforce a transaction that a consumer requests or authorizes, or in connection with: (1) Processing or servicing a financial product or service that a consumer requests or authorizes; (2) Maintaining or servicing the consumer's account with you, or with another entity as part of an extension of credit on behalf of such entity as part of a private label credit card program or other extension of credit on behalf of such entity; or (3) A proposed or actual securitization, secondary market sale or similar transaction related to a transaction of the consumer. (b) Necessary to effect, administer or enforce a transaction means that the disclosure is: (1) Required, or is one of the lawful or appropriate methods, to enforce your rights or the rights of other persons engaged in carrying out the financial transaction or providing the product or service; or (2) Required, or is a usual, appropriate or acceptable method: (i) To carry out the transaction or the product or service business of which the transaction is a part, and record, service or maintain the consumer's account in the ordinary course of providing the financial service or financial product; (ii) To administer or service benefits or claims relating to the transaction or the product or service business of which it is a part; (iii) To provide a confirmation, statement or other record of the transaction, or information on the status or value of the financial service or financial product to the consumer or the consumer's agent or broker; (iv) To accrue or recognize incentives or bonuses associated with the transaction that are provided by you or any other party; (v) In connection with: (A) The authorization, settlement, billing, processing, clearing, transferring, reconciling or collection of amounts charged, debited or otherwise paid using a debit, credit or other payment card, check or account number, or by other payment means; (B) The transfer of receivables, accounts or interests therein; or (C) The audit of debit, credit or other payment information." 17:17:2.0.1.1.26.3.1.3,17,Commodity and Securities Exchanges,I,,160,PART 160—PRIVACY OF CONSUMER FINANCIAL INFORMATION UNDER TITLE V OF THE GRAMM-LEACH-BLILEY ACT,C,Subpart C—Exceptions,,§ 160.15 Other exceptions to notice and opt out requirements.,CFTC,,,"[66 FR 21252, Apr. 27, 2001, as amended at 76 FR 43879, July 22, 2011]","(a) Exceptions to notice and opt out requirements. The requirements for initial notice in § 160.4(a)(2), for the opt out in §§ 160.7 and 160.10, and for initial notice in § 160.13 in connection with service providers and joint marketing do not apply when you disclose nonpublic personal information: (1) With the consent or at the direction of the consumer, provided that the consumer has not revoked the consent or direction; (2)(i) To protect the confidentiality or security or your records pertaining to the consumer, service, product or transaction; (ii) To protect against or prevent actual or potential fraud, unauthorized transactions, claims or other liability; (iii) For required institutional risk control or for resolving consumer disputes or inquiries; (iv) To persons holding a legal or beneficial interest relating to the consumer; or (v) To persons acting in a fiduciary or representative capacity on behalf of the consumer; (3) To provide information to insurance rate advisory organizations, guaranty funds or agencies, agencies that are rating you, persons that are assessing your compliance with industry standards, and your attorneys, accountants and auditors; (4) To the extent specifically permitted or required under other provisions of law and in accordance with the Right to Financial Privacy Act of 1978, 12 U.S.C. 3401 et seq., to law enforcement agencies (including a Federal functional regulator, the Secretary of the Treasury, with respect to 31 U.S.C. Chapter 53, Subchapter II (Records and Reports on Monetary Instruments and Transactions) and 12 U.S.C. Chapter 21 (Financial Recordkeeping), a State insurance authority, with respect to any person domiciled in that insurance authority's state that is engaged in providing insurance, and the Bureau of Consumer Financial Protection), self-regulatory organizations, or for an investigation on a matter related to public safety; (5)(i) To a consumer reporting agency in accordance with the Fair Credit Reporting Act, 15 U.S.C. 1681 et seq.; or (ii) From a consumer report reported by a consumer reporting agency; (6) In connection with a proposed or actual sale, merger, transfer or exchange of all or a portion of a business or operating unit if the disclosure of nonpublic personal information concerns solely consumers of such business or unit; or (7)(i) To comply with federal, state or local laws, rules and other applicable legal requirements; (ii) To comply with a properly authorized civil, criminal or regulatory investigation, or subpoena or summons by federal, state or local authorities; or (iii) To respond to judicial process or government regulatory authorities having jurisdiction over you for examination, compliance or other purposes as authorized by law. (b) Examples of consent and revocation of consent. (1) A consumer may specifically consent to your disclosure to a nonaffiliated mortgage lender of the value of the assets in the customer's account so that the lender can evaluate the consumer's application for a mortgage loan. (2) A consumer may revoke consent by subsequently exercising the right to opt out of future disclosures of nonpublic personal information as permitted under § 160.7(f)." 17:17:2.0.1.1.26.4.1.1,17,Commodity and Securities Exchanges,I,,160,PART 160—PRIVACY OF CONSUMER FINANCIAL INFORMATION UNDER TITLE V OF THE GRAMM-LEACH-BLILEY ACT,D,Subpart D—Relation to Other Laws; Effective Date,,§ 160.16 Protection of Fair Credit Reporting Act.,CFTC,,,,"Nothing in this part shall be construed to modify, limit or supersede the operation of the Fair Credit Reporting Act, 15 U.S.C. 1681 et seq., and no inference shall be drawn on the basis of the provisions of this part regarding whether information is transaction or experience information under section 603 of that Act." 17:17:2.0.1.1.26.4.1.2,17,Commodity and Securities Exchanges,I,,160,PART 160—PRIVACY OF CONSUMER FINANCIAL INFORMATION UNDER TITLE V OF THE GRAMM-LEACH-BLILEY ACT,D,Subpart D—Relation to Other Laws; Effective Date,,§ 160.17 Relation to state laws.,CFTC,,,"[66 FR 21252, Apr. 27, 2001, as amended at 76 FR 43879, July 22, 2011]","(a) In general. This part shall not be construed as superseding, altering or affecting any statute, regulation, order or interpretation in effect in any state, except to the extent that such state statute, regulation, order or interpretation is inconsistent with the provisions of this part, and then only to the extent of the inconsistency. (b) Greater protection under state law. For purposes of this section, a state statute, regulation, order or interpretation is not inconsistent with the provisions of this part if the protection such statute, regulation, order or interpretation affords any person is greater than the protection provided under this part, as determined by the Bureau of Consumer Financial Protection, after consultation with the Commission, on its own motion or upon the petition of any interested party." 17:17:2.0.1.1.26.4.1.3,17,Commodity and Securities Exchanges,I,,160,PART 160—PRIVACY OF CONSUMER FINANCIAL INFORMATION UNDER TITLE V OF THE GRAMM-LEACH-BLILEY ACT,D,Subpart D—Relation to Other Laws; Effective Date,,§ 160.18 Effective date; compliance date; transition rule.,CFTC,,,"[66 FR 21252, Apr. 27, 2001, as amended at 66 FR 24061, 24183, May 11, 2001; 67 FR 6790, Feb. 13, 2002]","(a) Effective date. This part is effective on June 21, 2001. In order to provide sufficient time for you to establish policies and systems to comply with the requirements for this part, the compliance date for this part is March 31, 2002. (b)(1) Notice requirement for consumers who are your customers on the effective date. By March 31, 2002, you must have provided an initial notice, as required by § 160.4, to consumers who are your customers on March 31, 2002. (2) Example. You provide an initial notice to consumers who are your customers on March 31, 2002 if, by that date, you have established a system for providing an initial notice to all new customers and have mailed the initial notice to all your existing customers. (c) One-year grandfathering of service agreements. Until March 31, 2003, a contract that you have entered into with a nonaffiliated third party to perform services for you or functions on your behalf satisfies the provisions of § 160.13(a)(1)(ii) even if the contract does not include a requirement that the third party maintain the confidentiality of nonpublic personal information, as long as you entered into the agreement on or before March 31, 2002." 17:17:2.0.1.1.26.4.1.4,17,Commodity and Securities Exchanges,I,,160,PART 160—PRIVACY OF CONSUMER FINANCIAL INFORMATION UNDER TITLE V OF THE GRAMM-LEACH-BLILEY ACT,D,Subpart D—Relation to Other Laws; Effective Date,,§§ 160.19-160.29 [Reserved],CFTC,,,, 17:17:2.0.1.1.26.4.1.5,17,Commodity and Securities Exchanges,I,,160,PART 160—PRIVACY OF CONSUMER FINANCIAL INFORMATION UNDER TITLE V OF THE GRAMM-LEACH-BLILEY ACT,D,Subpart D—Relation to Other Laws; Effective Date,,§ 160.30 Procedures to safeguard customer records and information.,CFTC,,,"[85 FR 29614, May 18, 2020, as amended at 89 FR 71820, Sept. 4, 2024]","Every futures commission merchant, retail foreign exchange dealer, commodity trading advisor, commodity pool operator, introducing broker, major swap participant, and swap dealer subject to the jurisdiction of the Commission must adopt policies and procedures that address administrative, technical and physical safeguards for the protection of customer records and information. These policies and procedures must be reasonably designed to: (a) Ensure the security and confidentiality of customer records and information; (b) Protect against any anticipated threats or hazards to the security or integrity of customer records and information; and (c) Protect against unauthorized access to or use of customer records or information that could result in substantial harm or inconvenience to any customer." 21:21:2.0.1.1.36.2.1.1,21,Food and Drugs,I,B,160,PART 160—EGGS AND EGG PRODUCTS,B,Subpart B—Requirements for Specific Standardized Eggs and Egg Products,,§ 160.100 Eggs.,FDA,,,,No regulation shall be promulgated fixing and establishing a reasonable definition and standard of identity for the food commonly known as eggs. 21:21:2.0.1.1.36.2.1.10,21,Food and Drugs,I,B,160,PART 160—EGGS AND EGG PRODUCTS,B,Subpart B—Requirements for Specific Standardized Eggs and Egg Products,,§ 160.190 Frozen egg yolks.,FDA,,,"[42 FR 14462, Mar. 15, 1977, as amended at 58 FR 2884, Jan. 6, 1993]","(a) Frozen egg yolks, frozen yolks is the food prepared by freezing egg yolks that conform to § 160.180, with such precautions that the finished food is free of viable Salmonella microorganisms. (b) Label declaration. Each of the ingredients used in the food shall be declared on the label as required by the applicable sections of parts 101 and 130 of this chapter." 21:21:2.0.1.1.36.2.1.2,21,Food and Drugs,I,B,160,PART 160—EGGS AND EGG PRODUCTS,B,Subpart B—Requirements for Specific Standardized Eggs and Egg Products,,§ 160.105 Dried eggs.,FDA,,,"[42 FR 14462, Mar. 15, 1977, as amended at 58 FR 2883, Jan. 6, 1993]","(a) Dried eggs, dried whole eggs are prepared by drying liquid eggs that conform to § 160.115, with such precautions that the finished food is free of viable Salmonella microorganisms. They may be powdered. Before drying, the glucose content of the liquid eggs may be reduced by one of the optional procedures set forth in paragraph (b) of this section. Either silicon dioxide complying with the provisions of § 172.480 of this chapter or sodium silicoaluminate may be added as an optional anticaking ingredient, but the amount of silicon dioxide used is not more than 1 percent and the amount of sodium silicoaluminate used is less than 2 percent by weight of the finished food. The finished food shall contain not less than 95 percent by weight total egg solids. (b) The optional glucose-removing procedures are: (1) Enzyme procedure. A glucose-oxidase-catalase preparation and hydrogen peroxide solution are added to the liquid eggs. The quantity used and the time of reaction are sufficient to substantially reduce the glucose content of the liquid eggs. The glucose-oxidase-catalase preparation used is one that is generally recognized as safe within the meaning of section 201(s) of the Federal Food, Drug, and Cosmetic Act. The hydrogen peroxide solution used shall comply with the specifications of the United States Pharmacopeia, except that it may exceed the concentration specified therein and it does not contain a preservative. (2) Yeast procedure. The pH of the liquid eggs is adjusted to the range of 6.0 to 7.0, if necessary, by the addition of dilute, chemically pure hydrochloric acid, and controlled fermentation is maintained by adding food-grade baker's yeast ( Saccharomyces cerevisiae ). The quantity of yeast used and the time of reaction are sufficient to substantially reduce the glucose content of the liquid eggs. (c) The name of the food for which a definition and standard of identity is prescribed by this section is “Dried eggs” or “Dried whole eggs” and if the glucose content was reduced, as provided in paragraph (b) of this section, the name shall be followed immediately by the statement “Glucose removed for stability” or “Stabilized, glucose removed”. (d)(1) When either of the optional anticaking ingredients specified in paragraph (a) of this section is used, the label shall bear the statement “Not more than 1 percent silicon dioxide added as an anticaking agent” or “Less than 2 percent sodium silicoaluminate added as an anticaking agent”, whichever is applicable. (2) The name of any optional ingredient used, as provided in paragraph (d)(1) of this section, shall be listed on the principal display panel or panels of the label with such prominence and conspicuousness as to render such statement likely to be read and understood by the ordinary individual under customary conditions of purchase. (e) Label declaration. Each of the ingredients used in the food shall be declared on the label as required by the applicable sections of parts 101 and 130 of this chapter." 21:21:2.0.1.1.36.2.1.3,21,Food and Drugs,I,B,160,PART 160—EGGS AND EGG PRODUCTS,B,Subpart B—Requirements for Specific Standardized Eggs and Egg Products,,§ 160.110 Frozen eggs.,FDA,,,"[42 FR 14462, Mar. 15, 1977, as amended at 58 FR 2883, Jan. 6, 1993]","(a) Frozen eggs, frozen whole eggs, frozen mixed eggs is the food prepared by freezing liquid eggs that conform to § 160.115, with such precautions that the finished food is free of viable Salmonella microorganisms. (b) Monosodium phosphate or monopotassium phosphate may be added either directly or in a water carrier, but the amount added does not exceed 0.5 percent of the weight of the frozen eggs. If a water carrier is used, it shall contain not less than 50 percent by weight of such monosodium phosphate or monopotassium phosphate. (c) When one of the optional ingredients specified in paragraph (b) of this section is used, the label shall bear the statement “Monosodium phosphate (or monopotassium phosphate) added to preserve color”, or, in case the optional ingredient used is added in a water carrier, the statement shall be “Monosodium phosphate (or monopotassium phosphate), with __ percent water as a carrier, added to preserve color”, the blank being filled in to show the percent by weight of water used in proportion to the weight of the finished food. The statement declaring the optional ingredient used shall appear on the principal display panel or panels with such prominence and conspicuousness as to render it likely to be read and understood under customary conditions of purchase. (d) Label declaration. Each of the ingredients used in the food shall be declared on the label as required by the applicable sections of parts 101 and 130 of this chapter." 21:21:2.0.1.1.36.2.1.4,21,Food and Drugs,I,B,160,PART 160—EGGS AND EGG PRODUCTS,B,Subpart B—Requirements for Specific Standardized Eggs and Egg Products,,§ 160.115 Liquid eggs.,FDA,,,"[42 FR 14462, Mar. 15, 1977, as amended at 58 FR 2883, Jan. 6, 1993]","(a) Liquid eggs, mixed eggs, liquid whole eggs, mixed whole eggs are eggs of the domestic hen broken from the shells and with yolks and whites in their natural proportion as so broken. They may be mixed, or mixed and strained, and they are pasteurized or otherwise treated to destroy all viable Salmonella microorganisms. Pasteurization or such other treatment is deemed to permit the adding of safe and suitable substances (other than chemical preservatives) that are essential to the method of pasteurization or other treatment used. For the purposes of this paragraph, safe and suitable substances are those that perform a useful function in the pasteurization or other treatment to render the liquid eggs free of viable Salmonella microorganisms, and that are not food additives as defined in section 201(s) of the Federal Food, Drug, and Cosmetic Act; or, if they are food additives, they are used in conformity with regulations established pursuant to section 409 of the act. (b) Label declaration. Each of the ingredients used in the food shall be declared on the label as required by the applicable sections of parts 101 and 130 of this chapter." 21:21:2.0.1.1.36.2.1.5,21,Food and Drugs,I,B,160,PART 160—EGGS AND EGG PRODUCTS,B,Subpart B—Requirements for Specific Standardized Eggs and Egg Products,,§ 160.140 Egg whites.,FDA,,,"[42 FR 14462, Mar. 15, 1977, as amended at 58 FR 2883, Jan. 6, 1993]","(a) Egg whites, liquid egg whites, liquid egg albumen is the food obtained from eggs of the domestic hen, broken from the shells and separated from yolks. The food may be mixed, or mixed and strained, and is pasteurized or otherwise treated to destroy all viable Salmonella microorganisms. Pasteurization or such other treatment is deemed to permit the adding of safe and suitable substances (other than chemical preservatives) that are essential to the method of pasteurization or other treatment used. Safe and suitable substances that aid in protecting or restoring the whipping properties of liquid egg whites may be added. For the purposes of this paragraph, safe and suitable substances are those that perform a useful function as whipping aids or in the pasteurization or other treatment to render liquid egg whites free of viable Salmonella microorganisms and that are not food additives as defined in section 201(s) of the Federal Food, Drug, and Cosmetic Act; or, if they are food additives, they are used in conformity with regulations established pursuant to section 409 of the act. (b) Any optional ingredients used as whipping aids, as provided for in paragraph (a) of this section, shall be named on the principal display panel or panels of labels with such prominence and conspicuousness as to render such names likely to be read and understood by ordinary individuals under customary conditions of purchase. (c) Label declaration. Each of the ingredients used in the food shall be declared on the label as required by the applicable sections of parts 101 and 130 of this chapter." 21:21:2.0.1.1.36.2.1.6,21,Food and Drugs,I,B,160,PART 160—EGGS AND EGG PRODUCTS,B,Subpart B—Requirements for Specific Standardized Eggs and Egg Products,,§ 160.145 Dried egg whites.,FDA,,,"[42 FR 14462, Mar. 15, 1977, as amended at 51 FR 11435, Apr. 3, 1986; 51 FR 25362, July 14, 1986; 54 FR 24895, June 12, 1989; 58 FR 2883, Jan. 6, 1993; 63 FR 14035, Mar. 24, 1998]","(a) The food dried egg whites, egg white solids, dried egg albumen, egg albumen solids is prepared by drying liquid egg whites conforming to the requirements of § 160.140 (or deviating from that section only by not being Salmonella free). As a preliminary step to drying, the lysozyme and avidin contents may be reduced. If lysozyme and avidin levels are reduced, cation exchange resins regulated for use under § 173.25 of this chapter shall be used. As a further preliminary step to drying, the glucose content of the liquid egg whites is reduced by adjusting the pH, where necessary, with food-grade acid and by following one of the optional procedures set forth in paragraph (b) of this section. If the food is prepared from liquid egg whites conforming in all respects to the requirements of § 160.140, drying shall be done with such precautions that the finished food is free of viable Salmonella microorganisms. If the food is prepared from liquid egg whites that are not Salmonella free, the dried product shall be so treated by heat or otherwise as to render the finished food free of viable Salmonella microorganisms. Dried egg whites may be powdered. (b) The optional glucose-removing procedures are: (1) Enzyme procedure. A glucose-oxidase-catalase preparation and hydrogen peroxide solution are added to liquid egg whites. The quantity used and the time of reaction are sufficient to substantially reduce the glucose content. The glucose-oxidase-catalase preparation used is one that is generally recognized as safe within the meaning of section 201(s) of the Federal Food, Drug, and Cosmetic Act. The hydrogen peroxide solution used shall comply with the specifications of the United States Pharmacopeia, except that it may exceed the concentration specified therein and it does not contain a preservative. (2) Controlled fermentation procedures —(i) Yeast procedure. Food-grade baker's yeast ( Saccharomyces cerevisiae ) is added to the liquid egg whites and controlled fermentation is maintained. The quantity of yeast used and the time of reaction are sufficient to substantially reduce the glucose content. (ii) Bacterial procedure. The liquid egg whites are subjected to the action of a culture of glucose-fermenting bacteria either generally recognized as safe within the meaning of section 201(s) of the Federal Food, Drug, and Cosmetic Act or the subject of a regulation established pursuant to section 409 of the act, and the culture is used in conformity with such regulation. The quantity of the culture used is sufficient to predominate in the fermentation and the time and temperature of reaction are sufficient to substantially reduce the glucose content. (c)(1) Dried egg whites in which the lysozyme and avidin have been reduced shall not be nutritionally inferior, as defined in § 101.3(e)(4)(i) of this chapter, and shall be considered nutritionally equivalent to untreated egg whites if they meet the conditions that the biological quality of the protein contained is equal to or greater than that of untreated egg white from the same batch of liquid egg white. (2) Compliance with the biological quality of protein requirement of paragraph (c)(1) of this section shall be determined by the analytical method prescribed in “Official Methods of Analysis of the Association of Official Analytical Chemists,” 14th Ed. (1984), section 43.253-43.257, “Protein Efficiency Ratio, Rat Bioassay, Final Action,” which is incorporated by reference. Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. (d) When the dried egg whites are prepared from liquid egg whites containing any optional ingredients added as whipping aids, as provided for in § 160.140(a), the common names of such optional ingredients shall be listed on the principal display panel or panels of the label with such prominence and conspicuousness as to render the names likely to be read and understood by ordinary individuals under customary conditions of purchase. (e) The name of the food for which a definition and standard of identity is prescribed in this section is alternatively “Dried egg whites”, Egg white solids”, “Dried egg albumen”, or “Egg albumen solids”. If the lysozyme and avidin content is reduced as provided in paragraph (a) of this section, the name shall be immediately preceded or followed by the statement “lysozyme and avidin reduced” when the dried egg whites are sold as such. When the dried egg whites are used in a fabricated food, the statement “lysozyme and avidin reduced” may be omitted from any declaration of ingredients required under § 101.4 of this chapter. (f) Label declaration. Each of the ingredients used in the food shall be declared on the label as required by the applicable sections of parts 101 and 130 of this chapter." 21:21:2.0.1.1.36.2.1.7,21,Food and Drugs,I,B,160,PART 160—EGGS AND EGG PRODUCTS,B,Subpart B—Requirements for Specific Standardized Eggs and Egg Products,,§ 160.150 Frozen egg whites.,FDA,,,"[42 FR 14462, Mar. 15, 1977, as amended at 58 FR 2883, Jan. 6, 1993]","(a) Frozen egg whites, frozen egg albumen is the food prepared by freezing liquid egg whites that conform to § 160.140, with such precautions that the finished food is free of viable Salmonella microorganisms. (b) When frozen egg whites are prepared from liquid egg whites containing any optional ingredients added as whipping aids, as provided for in § 160.140(a), the common names of such optional ingredients shall be listed on the principal display panel or panels of the label with such prominence and conspicuousness as to render such names likely to be read and understood by ordinary individuals under customary conditions of purchase. (c) Label declaration. Each of the ingredients used in the food shall be declared on the label as required by the applicable sections of parts 101 and 130 of this chapter." 21:21:2.0.1.1.36.2.1.8,21,Food and Drugs,I,B,160,PART 160—EGGS AND EGG PRODUCTS,B,Subpart B—Requirements for Specific Standardized Eggs and Egg Products,,§ 160.180 Egg yolks.,FDA,,,"[42 FR 14462, Mar. 15, 1977, as amended at 47 FR 11832, Mar. 19, 1982; 49 FR 10102, Mar. 19, 1984; 54 FR 24895, June 12, 1989; 58 FR 2883, Jan. 6, 1993; 63 FR 14035, Mar. 24, 1998]","(a) Egg yolks, liquid egg yolks, yolks, liquid yolks are yolks of eggs of the domestic hen so separated from the whites thereof as to contain not less than 43 percent total egg solids, as determined by the method prescribed in “Official Methods of Analysis of the Association of Official Analytical Chemists,” 13th Ed. (1980), sections 17.006 and 17.007 under “Total Solids, Vacuum Method (3)—Official Final Action,” which is incorporated by reference. Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. They may be mixed, or mixed and strained, and they are pasteurized or otherwise treated to destroy all viable Salmonella microorganisms. Pasteurization or such other treatment is deemed to permit the adding of safe and suitable substances (other than chemical preservatives) that are essential to the method of pasteurization or other treatment used. For the purposes of this paragraph, safe and suitable substances are those that perform a useful function in the pasteurization or other treatment to render the egg yolks free of viable Salmonella microorganisms, and that are not food additives as defined in section 201(s) of the Federal Food, Drug, and Cosmetic Act; or, if they are food additives, they are used in conformity with regulations established pursuant to section 409 of the act. (b) Label declaration. Each of the ingredients used in the food shall be declared on the label as required by the applicable sections of parts 101 and 130 of this chapter." 21:21:2.0.1.1.36.2.1.9,21,Food and Drugs,I,B,160,PART 160—EGGS AND EGG PRODUCTS,B,Subpart B—Requirements for Specific Standardized Eggs and Egg Products,,§ 160.185 Dried egg yolks.,FDA,,,"[42 FR 14462, Mar. 15, 1977, as amended at 58 FR 2883, Jan. 6, 1993]","(a) Dried egg yolks, dried yolks is the food prepared by drying egg yolks that conform to § 160.180, with such precautions that the finished food is free of viable Salmonella microorganisms. Before drying, the glucose content of the liquid egg yolks may be reduced by one of the optional procedures set forth in paragraph (b) of this section. Either silicon dioxide complying with the provisions of § 172.480 of this chapter or sodium silicoaluminate may be added as an optional anticaking ingredient, but the amount of silicon dioxide used is not more than 1 percent and the amount of sodium silicoaluminate used is less than 2 percent by weight of the finished food. The finished food shall contain not less than 95 percent by weight total egg solids. (b) The optional glucose-removing procedures are: (1) Enzyme procedure. A glucose-oxidase-catalase preparation and hydrogen peroxide solution are added to the liquid egg yolks. The quantity used and the time of reaction are sufficient to substantially reduce the glucose content of the liquid egg yolks. The glucose-oxidase-catalase preparation used is one that is generally recognized as safe within the meaning of section 201(s) of the Federal Food, Drug, and Cosmetic Act. The hydrogen peroxide solution used shall comply with the specification of the United States Pharmacopeia, except that it may exceed the concentration specified therein and it does not contain a preservative. (2) Yeast procedure. The pH of the liquid egg yolks is adjusted to the range of 6.0 to 7.0, if necessary, by the addition of dilute, chemically pure hydrochloric acid, and controlled fermentation is maintained by adding food-grade baker's yeast ( Saccharomyces cerevisiae ). The quantity of yeast used and the time of reaction are sufficient to substantially reduce the glucose content of the liquid egg yolks. (c) The name of the food for which a definition and standard of identity is prescribed by this section is “Dried egg yolks”, or “Dried yolks”, and if the glucose content was reduced, as provided in paragraph (b) of this section, the name shall be followed immediately by the statement “Glucose removed for stability” or “Stabilized, glucose removed”. (d)(1) When either of the optional anticaking ingredients specified in paragraph (a) of this section is used, the label shall bear the statement “Not more than 1 percent silicon dioxide added as an anticaking agent” or “Less than 2 percent sodium silicoaluminate added as an anticaking agent”, whichever is applicable. (2) The name of any optional ingredient used, as provided in paragraph (d)(1) of this section, shall be listed on the principal display panel or panels of the label with such prominence and conspicuousness as to render such statement likely to be read and understood by the ordinary individual under customary conditions of purchase. (e) Label declaration. Each of the ingredients used in the food shall be declared on the label as required by the applicable sections of parts 101 and 130 of this chapter." 33:33:2.0.1.6.27.1.195.1,33,Navigation and Navigable Waters,I,P,160,PART 160—PORTS AND WATERWAYS SAFETY—GENERAL,A,Subpart A—General,,§ 160.1 Purpose.,USCG,,,"[USCG-2020-0304, 85 FR 58280, Sept. 18, 2020]",This subchapter contains regulations implementing 46 U.S.C. Chapter 700 “Ports and Waterways Safety” and related statutes. 33:33:2.0.1.6.27.1.195.2,33,Navigation and Navigable Waters,I,P,160,PART 160—PORTS AND WATERWAYS SAFETY—GENERAL,A,Subpart A—General,,§ 160.3 Definitions.,USCG,,,"[CGD 90-020, 59 FR 36323, July 15, 1994, as amended at USCG-2010-0351, 75 FR 36286, June 25, 2010]","For the purposes of this subchapter: Bulk means material in any quantity that is shipped, stored, or handled without the benefit of package, label, mark or count and carried in integral or fixed independent tanks. Captain of the Port means the Coast Guard officer designated by the Commandant to command a Captain of the Port Zone as described in part 3 of this chapter. Commandant means the Commandant of the United States Coast Guard. Deviation means any departure from any rule in this subchapter. Director, Vessel Traffic Services means the Coast Guard officer designated by the Commandant to command a Vessel Traffic Service (VTS) as described in part 161 of this chapter. District Commander means the Coast Guard officer designated by the Commandant to command a Coast Guard District as described in part 3 of this chapter. ETA means estimated time of arrival. Length of Tow means, when towing with a hawser, the length in feet from the stern of the towing vessel to the stern of the last vessel in tow. When pushing ahead or towing alongside, length of tow means the tandem length in feet of the vessels in tow excluding the length of the towing vessel. Person means an individual, firm, corporation, association, partnership, or governmental entity. State means each of the several States of the United States, the District of Columbia, the Commonwealth of Puerto Rico, Guam, American Samoa, the United States Virgin Islands, the Trust Territories of the Pacific Islands, the Commonwealth of the Northern Marianas Islands, and any other commonwealth, territory, or possession of the United States. Tanker means a self-propelled tank vessel constructed or adapted primarily to carry oil or hazardous materials in bulk in the cargo spaces. Tank Vessel means a vessel that is constructed or adapted to carry, or that carries, oil or hazardous material in bulk as cargo or cargo residue. Vehicle means every type of conveyance capable of being used as a means of transportation on land. Vessel means every description of watercraft or other artificial contrivance used, or capable of being used, as a means of transportation on water. Vessel Traffic Services (VTS) means a service implemented under part 161 of this chapter by the United States Coast Guard designed to improve the safety and efficiency of vessel traffic and to protect the environment. The VTS has the capability to interact with marine traffic and respond to traffic situations developing in the VTS area. Vessel Traffic Service Area or VTS Area means the geographical area encompassing a specific VTS area of service as described in part 161 of this chapter. This area of service may be subdivided into sectors for the purpose of allocating responsibility to individual Vessel Traffic Centers or to identify different operating requirements. Although regulatory jurisdiction is limited to the navigable waters of the United States, certain vessels will be encouraged or may be required, as a condition of port entry, to report beyond this area to facilitate traffic management within the VTS area. VTS Special Area means a waterway within a VTS area in which special operating requirements apply." 33:33:2.0.1.6.27.1.195.3,33,Navigation and Navigable Waters,I,P,160,PART 160—PORTS AND WATERWAYS SAFETY—GENERAL,A,Subpart A—General,,§ 160.5 Delegations.,USCG,,,"[CGD 79-026, 48 FR 35404, Aug. 4, 1983, as amended by CGD 88-037, 53 FR 21815, June 10, 1988; CGD 90-020, 59 FR 36324, July 15, 1994; USCG-2010-0351, 75 FR 36287, June 25, 2010]","(a) District Commanders and Captains of the Ports are delegated the authority to establish safety zones. (b) Under the provisions of §§ 6.04-1 and 6.04-6 of this chapter, District Commanders and Captains of the Ports have been delegated authority to establish security zones. (c) Under the provisions of § 1.05-1 of this chapter, District Commanders have been delegated authority to establish regulated navigation areas. (d) Subject to the supervision of the cognizant Captain of the Port and District Commander, Directors, Vessel Traffic Services are delegated authority under 33 CFR 1.01-30 to discharge the duties of the Captain of the Port that involve directing the operation, movement, and anchorage of vessels within a Vessel Traffic Service area including management of vessel traffic within anchorages, regulated navigation areas and safety zones, and to enforce Vessel Traffic Service and ports and waterways safety regulations. This authority may be exercised by Vessel Traffic Center personnel. The Vessel Traffic Center may, within the Vessel Traffic Service area, provide information, make recommendations, or, to a vessel required under part 161 of this chapter to participate in a Vessel Traffic Service, issue an order, including an order to operate or anchor as directed; require the vessel to comply with orders issued; specify times of entry, movement or departure; restrict operations as necessary for safe operation under the circumstances; or take other action necessary for control of the vessel and the safety of the port or of the marine environment." 33:33:2.0.1.6.27.1.195.4,33,Navigation and Navigable Waters,I,P,160,PART 160—PORTS AND WATERWAYS SAFETY—GENERAL,A,Subpart A—General,,§ 160.7 Appeals.,USCG,,,"[CGD 79-026, 48 FR 35404, Aug. 4, 1983, as amended by CGD 88-052, 53 FR 25122, July 1, 1988; CGD 96-026, 61 FR 33668, June 28, 1996; CGD 97-023, 62 FR 33364, June 19, 1997; USCG-2002-12471, 67 FR 41333, June 18, 2002; USCG-2006-25150, 71 FR 39211, July 12, 2006; 72 FR 17409, Apr. 9, 2007; USCG-2010-0351, 75 FR 36287, June 25, 2010; USCG-2011-0257, 76 FR 31838, June 2, 2011; USCG-2014-0410, 79 FR 38439, July 7, 2014]","(a) Any person directly affected by a safety zone or an order or direction issued under this subchapter may request reconsideration by the official who issued it or in whose name it was issued. This request may be made orally or in writing, and the decision of the official receiving the request may be rendered orally or in writing. (b) Any person directly affected by the establishment of a safety zone or by an order or direction issued by, or on behalf of, a Captain of the Port may appeal to the District Commander through the Captain of the Port. The appeal must be in writing, except as allowed under paragraph (e) of this section, and shall contain complete supporting documentation and evidence which the appellant wishes to have considered. Upon receipt of the appeal, the District Commander may direct a representative to gather and submit documentation or other evidence which would be necessary or helpful to a resolution of the appeal. A copy of this documentation and evidence is made available to the appellant. The appellant is afforded five working days from the date of receipt to submit rebuttal materials. Following submission of all materials, the District Commander issues a ruling, in writing, on the appeal. Prior to issuing the ruling, the District Commander may, as a matter of discretion, allow oral presentation on the issues. (c) Any person directly affected by the establishment of a safety zone or by an order or direction issued by, or on behalf of, a District Commander, or who receives an unfavorable ruling on an appeal taken under paragraph (b) of this section may appeal to the Area Commander through the District Commander. The appeal must be in writing, except as allowed under paragraph (e) of this section, and shall contain complete supporting documentation and evidence which the appellant wishes to have considered. Upon receipt of the appeal, the Area Commander may direct a representative to gather and submit documentation or other evidence which would be necessary or helpful to a resolution of the appeal. A copy of this documentation and evidence is made available to the appellant. The appellant is afforded five working days from the date of receipt to submit rebuttal materials. Following submission of all materials, the Area Commander issues a ruling, in writing, on the appeal. Prior to issuing the ruling, the Area Commander may, as a matter of discretion, allow oral presentation on the issues. (d) Any person who receives an unfavorable ruling on an appeal taken under paragraph (c) of this section, may appeal to the Commandant (CG-5P), Attn: Assistant Commandant for Prevention, U.S. Coast Guard Stop 7501, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7501. The appeal must be in writing, except as allowed under paragraph (e) of this section. The Area Commander forwards the appeal, all the documents and evidence which formed the record upon which the order or direction was issued or the ruling under paragraph (c) of this section was made, and any comments which might be relevant, to the Assistant Commandant for Prevention. A copy of this documentation and evidence is made available to the appellant. The appellant is afforded 5 working days from the date of receipt to submit rebuttal materials to the Assistant Commandant for Prevention. The decision of the Assistant Commandant for Prevention is based upon the materials submitted, without oral argument or presentation. The decision of the Assistant Commandant for Prevention is issued in writing and constitutes final agency action. (e) If the delay in presenting a written appeal would have significant adverse impact on the appellant, the appeal under paragraphs (b) and (c) of this section may initially be presented orally. If an initial presentation of the appeal is made orally, the appellant must submit the appeal in writing within five days of the oral presentation to the Coast Guard official to whom the presentation was made. The written appeal must contain, at a minimum, the basis for the appeal and a summary of the material presented orally. If requested, the official to whom the appeal is directed may stay the effect of the action while the ruling is being appealed." 33:33:2.0.1.6.27.2.195.1,33,Navigation and Navigable Waters,I,P,160,PART 160—PORTS AND WATERWAYS SAFETY—GENERAL,B,Subpart B—Control of Vessel and Facility Operations,,§ 160.101 Purpose.,USCG,,,,"This subpart describes the authority exercised by District Commanders and Captains of the Ports to insure the safety of vessels and waterfront facilities, and the protection of the navigable waters and the resources therein. The controls described in this subpart are directed to specific situations and hazards." 33:33:2.0.1.6.27.2.195.2,33,Navigation and Navigable Waters,I,P,160,PART 160—PORTS AND WATERWAYS SAFETY—GENERAL,B,Subpart B—Control of Vessel and Facility Operations,,§ 160.103 Applicability.,USCG,,,,"(a) This subpart applies to any— (1) Vessel on the navigable waters of the United States, except as provided in paragraphs (b) and (c) of this section; (2) Bridge or other structure on or in the navigable waters of the United States; and (3) Land structure or shore area immediately adjacent to the navigable waters of the United States. (b) This subpart does not apply to any vessel on the Saint Lawrence Seaway. (c) Except pursuant to international treaty, convention, or agreement, to which the United States is a party, this subpart does not apply to any foreign vessel that is not destined for, or departing from, a port or place subject to the jurisdiction of the United States and that is in: (1) Innocent passage through the territorial sea of the United States; (2) Transit through the navigable waters of the United States which form a part of an international strait." 33:33:2.0.1.6.27.2.195.3,33,Navigation and Navigable Waters,I,P,160,PART 160—PORTS AND WATERWAYS SAFETY—GENERAL,B,Subpart B—Control of Vessel and Facility Operations,,§ 160.105 Compliance with orders.,USCG,,,,Each person who has notice of the terms of an order issued under this subpart must comply with that order. 33:33:2.0.1.6.27.2.195.4,33,Navigation and Navigable Waters,I,P,160,PART 160—PORTS AND WATERWAYS SAFETY—GENERAL,B,Subpart B—Control of Vessel and Facility Operations,,§ 160.107 Denial of entry.,USCG,,,"[CGD 79-026, 48 FR 35404, Aug. 4, 1983, as amended by USCG-2020-0304, 85 FR 58280, Sept. 18, 2020]","Each District Commander or Captain of the Port, subject to recognized principles of international law, may deny entry into the navigable waters of the United States or to any port or place under the jurisdiction of the United States, and within the district or zone of that District Commander or Captain of the Port, to any vessel not in compliance with the provisions of the Port and Tanker Safety Act (46 U.S.C. Chapter 700) or the regulations issued thereunder." 33:33:2.0.1.6.27.2.195.5,33,Navigation and Navigable Waters,I,P,160,PART 160—PORTS AND WATERWAYS SAFETY—GENERAL,B,Subpart B—Control of Vessel and Facility Operations,,§ 160.109 Waterfront facility safety.,USCG,,,"[CGD 79-026, 48 FR 35404, Aug. 4, 1983, as amended by USCG-1998-3799, 63 FR 35531, June 30, 1998]","(a) To prevent damage to, or the destruction of, any bridge or other structure on or in the navigable waters of the United States, or any land structure or shore area immediately adjacent to such waters, and to protect the navigable waters and the resources therein from harm resulting from vessel or structure damage, destruction, or loss, each District Commander or Captain of the Port may: (1) Direct the handling, loading, unloading, storage, and movement (including the emergency removal, control and disposition) of explosives or other dangerous articles and substances, including oil or hazardous material as those terms are defined in 46 U.S.C. 2101 on any structure on or in the navigable waters of the United States, or any land structure or shore area immediately adjacent to those waters; and (2) Conduct examinations to assure compliance with the safety equipment requirements for structures." 33:33:2.0.1.6.27.2.195.6,33,Navigation and Navigable Waters,I,P,160,PART 160—PORTS AND WATERWAYS SAFETY—GENERAL,B,Subpart B—Control of Vessel and Facility Operations,,§ 160.111 Special orders applying to vessel operations.,USCG,,,,"Each District Commander or Captain of the Port may order a vessel to operate or anchor in the manner directed when: (a) The District Commander or Captain of the Port has reasonable cause to believe that the vessel is not in compliance with any regulation, law or treaty; (b) The District Commander or Captain of the Port determines that the vessel does not satisfy the conditions for vessel operation and cargo transfers specified in § 160.113; or (c) The District Commander or Captain of the Port has determined that such order is justified in the interest of safety by reason of weather, visibility, sea conditions, temporary port congestion, other temporary hazardous circumstances, or the condition of the vessel." 33:33:2.0.1.6.27.2.195.7,33,Navigation and Navigable Waters,I,P,160,PART 160—PORTS AND WATERWAYS SAFETY—GENERAL,B,Subpart B—Control of Vessel and Facility Operations,,§ 160.113 Prohibition of vessel operation and cargo transfers.,USCG,,,"[CGD 79-026, 48 FR 35404, Aug. 4, 1983, as amended by CGD 96-026, 61 FR 33668, June 28, 1996; USCG-1998-3799, 63 FR 35531, June 30, 1998; USCG-2006-24371, 74 FR 11212, Mar. 16, 2009]","(a) Each District Commander or Captain of the Port may prohibit any vessel, subject to the provisions of chapter 37 of Title 46, U.S. Code, from operating in the navigable waters of the United States, or from transferring cargo or residue in any port or place under the jurisdiction of the United States, and within the district or zone of that District Commander or Captain of the Port, if the District Commander or the Captain of the Port determines that the vessel's history of accidents, pollution incidents, or serious repair problems creates reason to believe that the vessel may be unsafe or pose a threat to the marine environment. (b) The authority to issue orders prohibiting operation of the vessels or transfer of cargo or residue under paragraph (a) of this section also applies if the vessel: (1) Fails to comply with any applicable regulation; (2) Discharges oil or hazardous material in violation of any law or treaty of the United States; (3) Does not comply with applicable vessel traffic service requirements; (4) While underway, does not have at least one deck officer on the navigation bridge who is capable of communicating in the English language. (c) When a vessel has been prohibited from operating in the navigable waters of the United States under paragraphs (a) or (b) of this section, the District Commander or Captain of the Port may allow provisional entry into the navigable waters of the United States, or into any port or place under the jurisdiction of the United States and within the district or zone of that District Commander or Captain of the Port, if the owner or operator of such vessel proves to the satisfaction of the District Commander or Captain of the Port, that the vessel is not unsafe or does not pose a threat to the marine environment, and that such entry is necessary for the safety of the vessel or the persons on board. (d) A vessel which has been prohibited from operating in the navigable waters of the United States, or from transferring cargo or residue in a port or place under the jurisdiction of the United States under the provisions of paragraph (a) or (b)(1), (2) or (3) of this section, may be allowed provisional entry if the owner or operator proves, to the satisfaction of the District Commander or Captain of the Port that has jurisdiction, that the vessel is no longer unsafe or a threat to the environment, and that the condition which gave rise to the prohibition no longer exists." 33:33:2.0.1.6.27.2.195.8,33,Navigation and Navigable Waters,I,P,160,PART 160—PORTS AND WATERWAYS SAFETY—GENERAL,B,Subpart B—Control of Vessel and Facility Operations,,§ 160.115 Withholding of clearance.,USCG,,,"[CGD 79-026, 48 FR 35404, Aug. 4, 1983; 48 FR 39059, Aug. 29, 1983, as amended by USCG-1998-3799, 63 FR 35531, June 30, 1998]","Each District Commander or Captain of the Port may request the Secretary of the Treasury, or the authorized representative thereof, to withhold or revoke the clearance required by 46 U.S.C. App. 91 of any vessel, the owner or operator of which is subject to any penalties under 46 U.S.C. 70036." 33:33:2.0.1.6.27.3.195.1,33,Navigation and Navigable Waters,I,P,160,PART 160—PORTS AND WATERWAYS SAFETY—GENERAL,C,"Subpart C—Notification of Arrival, Hazardous Conditions, and Certain Dangerous Cargoes",,§ 160.201 General.,USCG,,,"[80 FR 5330, Jan. 30, 2015]","This subpart contains requirements and procedures for submitting a notice of arrival (NOA), and a notice of hazardous condition. The sections in this subpart describe: (a) Applicability and exemptions from requirements in this subpart; (b) Required information in an NOA; (c) Required updates to an NOA; (d) Methods and times for submission of an NOA, and updates to an NOA; (e) How to obtain a waiver; and (f) Requirements for submission of the notice of hazardous condition. For notice-of-arrival requirements for the U.S. Outer Continental Shelf, see 33 CFR part 146." 33:33:2.0.1.6.27.3.195.10,33,Navigation and Navigable Waters,I,P,160,PART 160—PORTS AND WATERWAYS SAFETY—GENERAL,C,"Subpart C—Notification of Arrival, Hazardous Conditions, and Certain Dangerous Cargoes",,§ 160.214 Waivers.,USCG,,,,"The Captain of the Port may waive, within that Captain of the Port's designated zone, any of the requirements of this subpart for any vessel or class of vessels upon finding that the vessel, route, area of operations, conditions of the voyage, or other circumstances are such that application of this subpart is unnecessary or impractical for purposes of safety, environmental protection, or national security." 33:33:2.0.1.6.27.3.195.11,33,Navigation and Navigable Waters,I,P,160,PART 160—PORTS AND WATERWAYS SAFETY—GENERAL,C,"Subpart C—Notification of Arrival, Hazardous Conditions, and Certain Dangerous Cargoes",,§ 160.215 Force majeure.,USCG,,,"[USCG-2000-7080, 81 FR 59137, Aug. 29, 2016]","When a vessel is bound for a port or place of the United States under force majeure, it must comply with the requirements in this section, but not other sections of this subpart. The vessel must report the following information to the nearest Captain of the Port as soon as practicable: (a) The vessel Master's intentions; (b) Any hazardous conditions as defined in § 160.202; and (c) If the vessel is carrying certain dangerous cargo or controlling a vessel carrying certain dangerous cargo, the amount and name of each CDC carried, including cargo UN number if applicable." 33:33:2.0.1.6.27.3.195.12,33,Navigation and Navigable Waters,I,P,160,PART 160—PORTS AND WATERWAYS SAFETY—GENERAL,C,"Subpart C—Notification of Arrival, Hazardous Conditions, and Certain Dangerous Cargoes",,§ 160.216 Notice of hazardous conditions.,USCG,,,"[USCG-2000-7080, 81 FR 28017, May 9, 2016. Redesignated by USCG-2000-7080, 81 FR 59136, Aug. 29, 2016]","(a) Whenever there is a hazardous condition either on board a vessel or caused by a vessel or its operation, the owner, agent, master, operator, or person in charge must immediately notify the nearest Coast Guard Sector Office or Group Office, and in addition submit any report required by 46 CFR 4.05-10. (b) When the hazardous condition involves cargo loss or jettisoning as described in 33 CFR 97.115, the notification required by paragraph (a) of this section must include— (1) What was lost, including a description of cargo, substances involved, and types of packages; (2) How many were lost, including the number of packages and quantity of substances they represent; (3) When the incident occurred, including the time of the incident or period of time over which the incident occurred; (4) Where the incident occurred, including the exact or estimated location of the incident, the route the ship was taking, and the weather (wind and sea) conditions at the time or approximate time of the incident; and (5) How the incident occurred, including the circumstances of the incident, the type of securing equipment that was used, and any other material failures that may have contributed to the incident." 33:33:2.0.1.6.27.3.195.2,33,Navigation and Navigable Waters,I,P,160,PART 160—PORTS AND WATERWAYS SAFETY—GENERAL,C,"Subpart C—Notification of Arrival, Hazardous Conditions, and Certain Dangerous Cargoes",,§ 160.202 Definitions.,USCG,,,"[USCG-2002-11865, 68 FR 9543, Feb. 28, 2003, as amended by USCG-2004-19963, 70 FR 74669, Dec. 16, 2005; 75 FR 59620, Sept. 28, 2010. Redesignated and amended by USCG-2005-21869, 80 FR 5330, Jan. 30, 2015; USCG-2022-0802, 90 FR 6453, Jan. 17, 2025]","Terms in this subpart that are not defined in this section or in § 160.3 have the same meaning as those terms in 46 U.S.C. 2101. As used in this subpart— Agent means any person, partnership, firm, company or corporation engaged by the owner or charterer of a vessel to act in their behalf in matters concerning the vessel. Barge means a non-self propelled vessel engaged in commerce. Boundary waters mean the waters from main shore to main shore of the lakes and rivers and connecting waterways, or the portions thereof, along which the international boundary between the United States and the Dominion of Canada passes, including all bays, arms, and inlets thereof, but not including tributary waters which in their natural channels would flow into such lakes, rivers, and waterways, or waters flowing from such lakes, rivers, and waterways, or the waters of rivers flowing across the boundary. Carried in bulk means a commodity that is loaded or carried on board a vessel without containers or labels and received and handled without mark or count. Certain dangerous cargo (CDC) includes any of the following: (1) Division 1.1 or 1.2 explosives as defined in 49 CFR 173.50. (2) Division 1.5D blasting agents for which a permit is required under 49 CFR 176.415 or, for which a permit is required as a condition of a Research and Special Programs Administration exemption. (3) Division 2.3 “poisonous gas”, as listed in 49 CFR 172.101 that is also a “material poisonous by inhalation” as defined in 49 CFR 171.8, and that is in a quantity in excess of 1 metric ton per vessel. (4) Division 5.1 oxidizing materials for which a permit is required under 49 CFR 176.415 or for which a permit is required as a condition of a Research and Special Programs Administration exemption. (5) A liquid material that has a primary or subsidiary classification of Division 6.1 “poisonous material” as listed in 49 CFR 172.101 that is also a “material poisonous by inhalation,” as defined in 49 CFR 171.8 and that is in a bulk packaging, or that is in a quantity in excess of 20 metric tons per vessel when not in a bulk packaging. (6) Class 7, “highway route controlled quantity” radioactive material or “fissile material, controlled shipment,” as defined in 49 CFR 173.403. (7) All bulk liquefied gas cargo carried under 46 CFR 151.50-31 or listed in 46 CFR 154.7 that is flammable and/or toxic and that is not carried as certain dangerous cargo residue (CDC residue). (8) The following bulk liquids except when carried as CDC residue: (i) Acetone cyanohydrin; (ii) Allyl alcohol; (iii) Chlorosulfonic acid; (iv) Crotonaldehyde; (v) Ethylene chlorohydrin; (vi) Ethylene dibromide; (vii) Methacrylonitrile; (viii) Oleum (fuming sulfuric acid); and (ix) Propylene oxide, alone or mixed with ethylene oxide. (9) The following bulk solids: (i) Ammonium nitrate listed as a Division 5.1 (oxidizing) material in 49 CFR 172.101 except when carried as CDC residue; and (ii) Ammonium nitrate based fertilizer listed as a Division 5.1 (oxidizing) material in 49 CFR 172.101 except when carried as CDC residue. Certain dangerous cargo residue (CDC residue) includes any of the following: (1) Ammonium nitrate in bulk or ammonium nitrate based fertilizer in bulk remaining after all saleable cargo is discharged, not exceeding 1,000 pounds in total and not individually accumulated in quantities exceeding two cubic feet. (2) For bulk liquids and liquefied gases, the cargo that remains onboard in a cargo system after discharge that is not accessible through normal transfer procedures, with the exception of the following bulk liquefied gas cargoes carried under 46 CFR 151.50-31 or listed in 46 CFR 154.7: (i) Ammonia, anhydrous; (ii) Chlorine; (iii) Ethane; (iv) Ethylene oxide; (v) Methane (LNG); (vi) Methyl bromide; (vii) Sulfur dioxide; and (viii) Vinyl chloride. Charterer means the person or organization that contracts for the majority of the carrying capacity of a ship for the transportation of cargo to a stated port for a specified period. This includes “time charterers” and “voyage charterers.” Crewmember means all persons carried on board the vessel to provide navigation and maintenance of the vessel, its machinery, systems, and arrangements essential for propulsion and safe navigation or to provide services for other persons on board. Embark means when a crewmember or a person in addition to the crew joins the vessel. Ferry schedule means a published document that: (1) Identifies locations a ferry travels to and from; (2) Lists the times of departures and arrivals; and (3) Identifies the portion of the year in which the ferry maintains this schedule. Foreign vessel means a vessel of foreign registry or operated under the authority of a country except the United States. Great Lakes means Lakes Superior, Michigan, Huron, Erie, and Ontario, their connecting and tributary waters, the Saint Lawrence River as far as Saint Regis, and adjacent port areas. Gross tons means the tonnage determined by the tonnage authorities of a vessel's flag state in accordance with the national tonnage rules in force before the entry into force of the International Convention on Tonnage Measurement of Ships, 1969 (“Convention”). For a vessel measured only under Annex I of the Convention, gross tons means that tonnage. For a vessel measured under both systems, the higher gross tonnage is the tonnage used for the purposes of the 300-gross-ton threshold. Hazardous condition means any condition that may adversely affect the safety of any vessel, bridge, structure, or shore area or the environmental quality of any port, harbor, or navigable waterway of the United States. It may, but need not, involve collision, allision, fire, explosion, grounding, leaking, damage, cyber incident, injury or illness of a person aboard, or manning-shortage. Nationality means the state (nation) in which a person is a citizen or to which a person owes permanent allegiance. Operating exclusively within a single Captain of the Port zone refers to vessel movements within the boundaries of a single COTP zone, e.g., from one dock to another, one berth to another, one anchorage to another, or any combination of such transits. Once a vessel has arrived in a port in a COPT zone, it would not be considered as departing from a port or place simply because of its movements within that specific port. Operator means any person including, but not limited to, an owner, a charterer, or another contractor who conducts, or is responsible for, the operation of a vessel. Persons in addition to crewmembers mean any person onboard the vessel, including passengers, who are not included on the list of crewmembers. Port or place of departure means any port or place in which a vessel is anchored or moored. Port or place of destination means any port or place in which a vessel is bound to anchor or moor. Public vessel means a vessel that is owned or demise-(bareboat) chartered by the government of the United States, by a State or local government, or by the government of a foreign country and that is not engaged in commercial service. Time charterer means the party who hires a vessel for a specific amount of time. The owner and his crew manage the vessel, but the charterer selects the ports of destination. Voyage charterer means the party who hires a vessel for a single voyage. The owner and his crew manage the vessel, but the charterer selects the ports of destination." 33:33:2.0.1.6.27.3.195.3,33,Navigation and Navigable Waters,I,P,160,PART 160—PORTS AND WATERWAYS SAFETY—GENERAL,C,"Subpart C—Notification of Arrival, Hazardous Conditions, and Certain Dangerous Cargoes",,§ 160.203 Applicability.,USCG,,,"[USCG-2002-11865, 68 FR 9543, Feb. 28, 2003, as amended by USCG-2004-19963, 70 FR 74669, Dec. 16, 2005. Redesignated and amended at 80 FR 5330, 5331, Jan. 30, 2015]","(a) This subpart applies to the following vessels that are bound for or departing from ports or places within the navigable waters of the United States, as defined in 33 CFR 2.36(a), which includes internal waters and the territorial seas of the United States, and any deepwater port as defined in 33 CFR 148.5: (1) U.S. vessels in commercial service, and (2) All foreign vessels. (b) Unless otherwise specified in this subpart, the owner, agent, master, operator, or person in charge of a vessel regulated by this subpart is responsible for compliance with the requirements in this subpart. (c) Towing vessels controlling a barge or barges required to submit an NOA under this subpart must submit only one NOA containing the information required for the towing vessel and each barge under its control." 33:33:2.0.1.6.27.3.195.4,33,Navigation and Navigable Waters,I,P,160,PART 160—PORTS AND WATERWAYS SAFETY—GENERAL,C,"Subpart C—Notification of Arrival, Hazardous Conditions, and Certain Dangerous Cargoes",,§ 160.204 Exemptions and exceptions.,USCG,,,"[USCG-2002-11865, 68 FR 9543, Feb. 28, 2003, as amended by USCG-2003-14749, 68 FR 39313, July 1, 2003; 68 FR 63735, Nov. 10, 2003. Redesignated and amended at 80 FR 5330, 5331, Jan. 30, 2015]","(a) Except for reporting notice of hazardous conditions, the following vessels are exempt from requirements in this subpart: (1) A passenger or offshore supply vessel when employed in the exploration for or in the removal of oil, gas, or mineral resources on the continental shelf. (2) An oil spill response vessel (OSRV) when engaged in actual spill response operations or during spill response exercises. (3) After December 31, 2015, a vessel required by 33 CFR 165.830 or 165.921 to report its movements, its cargo, or the cargo in barges it is towing. (4) A United States or Canadian vessel engaged in the salving operations of any property wrecked, or rendering aid and assistance to any vessels wrecked, disabled, or in distress, in waters specified in Article II of the 1908 Treaty of Extradition, Wrecking and Salvage (35 Stat. 2035; Treaty Series 502). (5) The following vessels neither carrying certain dangerous cargo nor controlling another vessel carrying certain dangerous cargo: (i) A foreign vessel 300 gross tons or less not engaged in commercial service. (ii) A vessel operating exclusively within a single Captain of the Port zone. Captain of the Port zones are defined in 33 CFR part 3. (iii) A U.S. towing vessel and a U.S. barge operating solely between ports or places of the contiguous 48 states, Alaska, and the District of Columbia. (iv) A public vessel. (v) Except for a tank vessel, a U.S. vessel operating solely between ports or places of the United States on the Great Lakes. (vi) A U.S. vessel 300 gross tons or less, engaged in commercial service not coming from a foreign port or place. (vii) Each ferry on a fixed route that is described in an accurate schedule that is submitted by the ferry operator, along with information in paragraphs (a)(5)(vii)(A) through (J) of this section, to the Captain of the Port for each port or place of destination listed in the schedule at least 24 hours in advance of the first date and time of arrival listed on the schedule. At least 24 hours before the first date and time of arrival listed on the ferry schedule, each ferry operator who submits a schedule under paragraph (a)(5)(vii) of this section must also provide the following information to the Captain of the Port for each port or place of destination listed in the schedule for the ferry, and if the schedule or the following submitted information changes, the ferry operator must submit an updated schedule at least 24 hours in advance of the first date and time of arrival listed on the new schedule and updates on the following items whenever the submitted information is no longer accurate: (A) Name of the vessel; (B) Country of registry of the vessel; (C) Call sign of the vessel; (D) International Maritime Organization (IMO) international number or, if the vessel does not have an assigned IMO international number, the official number of the vessel; (E) Name of the registered owner of the vessel; (F) Name of the operator of the vessel; (G) Name of the vessel's classification society or recognized organization, if applicable; (H) Each port or place of destination; (I) Estimated dates and times of arrivals at and departures from these ports or places; and (J) Name and telephone number of a 24-hour point of contact. (b) A vessel less than 500 gross tons is not required to submit the International Safety Management (ISM) Code Notice (Entry 7 in Table 160.206 of § 160.206). (c) A U.S. vessel is not required to submit the International Ship and Port Facility Security (ISPS) Code Notice information (Entry 8 in Table 160.206 of § 160.206)." 33:33:2.0.1.6.27.3.195.5,33,Navigation and Navigable Waters,I,P,160,PART 160—PORTS AND WATERWAYS SAFETY—GENERAL,C,"Subpart C—Notification of Arrival, Hazardous Conditions, and Certain Dangerous Cargoes",,§ 160.205 Notices of arrival.,USCG,,,"[80 FR 5331, Jan. 30, 2015]","The owner, agent, Master, operator, or person in charge of a vessel must submit notices of arrival consistent with the requirements in this subpart." 33:33:2.0.1.6.27.3.195.6,33,Navigation and Navigable Waters,I,P,160,PART 160—PORTS AND WATERWAYS SAFETY—GENERAL,C,"Subpart C—Notification of Arrival, Hazardous Conditions, and Certain Dangerous Cargoes",,§ 160.206 Information required in an NOA.,USCG,,,"[80 FR 5331, Jan. 30, 2015]","(a) Information required. With the exceptions noted in paragraph (b) of this section, each NOA must contain all of the information items specified in Table 160.206. Vessel owners and operators should protect any personal information they gather in preparing notices for transmittal to the National Vessel Movement Center (NVMC) to prevent unauthorized disclosure of that information. Table 160.206—NOA Information Items Note to Table 160.206. For items with an asterisk (*), see paragraph (b) of this section. Submitting a response for item 6 indicating that navigation equipment is not operating properly does not serve as notice to the District Commander, Captain of the Port, or Vessel Traffic Center, under 33 CFR 164.53. (b) Exceptions. If a crewmember or person on board other than a crewmember is not required to carry a passport for travel, then passport information required in Table 160.206 by items (4)(iv) and (5) (iv) need not be provided for that person." 33:33:2.0.1.6.27.3.195.7,33,Navigation and Navigable Waters,I,P,160,PART 160—PORTS AND WATERWAYS SAFETY—GENERAL,C,"Subpart C—Notification of Arrival, Hazardous Conditions, and Certain Dangerous Cargoes",,§ 160.208 Updates to a submitted NOA.,USCG,,,"[USCG-2002-11865, 68 FR 9543, Feb. 28, 2003,as amended by USCG-2005-21869, 80 FR 5333, Jan. 30, 2015]","(a) Unless otherwise specified in this section, whenever events cause NOA information submitted for a vessel to become inaccurate, or the submitter to realize that data submitted was inaccurate, the owner, agent, Master, operator, or person in charge of that vessel must submit an update within the times required in § 160.212. (b) Changes in the following information need not be reported: (1) Changes in arrival or departure times that are less than six (6) hours; (2) Changes in vessel location or position of the vessel at the time of reporting (entry (2)(vi) to Table 160.206); and (3) Changes to crewmembers' position or duties on the vessel (entry (4)(vii) to Table 160.206). (c) When reporting updates, revise and resubmit the NOA." 33:33:2.0.1.6.27.3.195.8,33,Navigation and Navigable Waters,I,P,160,PART 160—PORTS AND WATERWAYS SAFETY—GENERAL,C,"Subpart C—Notification of Arrival, Hazardous Conditions, and Certain Dangerous Cargoes",,§ 160.210 Methods for submitting an NOA.,USCG,,,"[USCG-2005-21869, 80 FR 5333, Jan. 30, 2015]","(a) National Vessel Movement Center (NVMC). Except as otherwise provided in this paragraph or paragraph (b) of this section, vessels must submit NOA information required by § 160.206 to the NVMC using methods currently specified at www.nvmc.uscg.gov, which includes submission through the NVMC electronic Notice of Arrival and Departure (eNOAD) World Wide Web site, and XML, which includes the Excel Workbook format. These data may also be submitted using other methods that may be added as future options on www.nvmc.uscg.gov. XML spreadsheets may be submitted via email to enoad@nvmc.uscg.gov. If a vessel operator must submit an NOA or an update, for a vessel in an area without internet access or when experiencing technical difficulties with an onboard computer, and he or she has no shore-side support available, the vessel operator may fax or phone the submission to the NVMC. Fax at 1-800-547-8724 or 304-264-2684. Workbook available at www.nvmc.uscg.gov; or, telephone at 1-800-708-9823 or 304-264-2502. (b) Saint Lawrence Seaway. Those vessels transiting the Saint Lawrence Seaway inbound, bound for a port or place in the United States, may meet the submission requirements of paragraph (a) of this section by submitting the required information to the Saint Lawrence Seaway Development Corporation and the Saint Lawrence Seaway Management Corporation of Canada using methods specified at www.nvmc.uscg.gov." 33:33:2.0.1.6.27.3.195.9,33,Navigation and Navigable Waters,I,P,160,PART 160—PORTS AND WATERWAYS SAFETY—GENERAL,C,"Subpart C—Notification of Arrival, Hazardous Conditions, and Certain Dangerous Cargoes",,§ 160.212 When to submit an NOA.,USCG,,,"[USCG-2005-21869, 80 FR 5333, Jan. 30, 2015]","(a) Submission of an NOA. (1) Except as set out in paragraphs (a)(2) and (a)(3) of this section, all vessels must submit NOAs within the times required in paragraph (a)(4) of this section. (2) Towing vessels, when in control of a vessel carrying CDC and operating solely between ports or places of the contiguous 48 states, Alaska, and the District of Columbia, must submit an NOA before departure but at least 12 hours before arriving at the port or place of destination. (3) U.S. vessels 300 gross tons or less, arriving from a foreign port or place, and whose voyage time is less than 24 hours must submit an NOA at least 60 minutes before departure from the foreign port or place. Also, Canadian vessels 300 gross tons or less, arriving directly from Canada, via boundary waters, to a United States port or place on the Great Lakes, whose voyage time is less than 24 hours must submit an NOA at least 60 minutes before departure from the Canadian port or place. (4) Times for submitting NOAs are as follows: (b) Submission of updates to an NOA. (1) Except as set out in paragraphs (b)(2) and (b)(3) of this section, vessels must submit updates in NOA information within the times required in paragraph (b)(4) of this section. (2) Towing vessels, when in control of a vessel carrying CDC and operating solely between ports or places in the contiguous 48 states, Alaska, and the District of Columbia, must submit updates to an NOA as soon as practicable but at least 6 hours before entering the port or place of destination. (3) U.S. vessels 300 gross tons or less, arriving from a foreign port or place, whose voyage time is— (i) Less than 24 hours but greater than 6 hours, must submit updates to an NOA as soon as practicable, but at least 6 hours before entering the port or place of destination. (ii) Less than or equal to 6 hours, must submit updates to an NOA as soon as practicable, but at least 60 minutes before departure from the foreign port or place. (4) Times for submitting updates to NOAs are as follows:" 33:33:2.0.1.6.27.4.195.1,33,Navigation and Navigable Waters,I,P,160,PART 160—PORTS AND WATERWAYS SAFETY—GENERAL,D,Subpart D—Crewmember Identification,,§ 160.300 Applicability.,USCG,,,,"(a) This subpart applies to crewmembers on the following vessels in the navigable waters of the United States en route to a U.S. port or place of destination or at a U.S. port or place: (1) A foreign vessel engaged in commercial service, and (2) A U.S. vessel engaged in commercial service and coming from a foreign port or place of departure. (b) This subpart also applies to the operators of the vessels listed in paragraph (a) of this section." 33:33:2.0.1.6.27.4.195.2,33,Navigation and Navigable Waters,I,P,160,PART 160—PORTS AND WATERWAYS SAFETY—GENERAL,D,Subpart D—Crewmember Identification,,§ 160.305 Exceptions.,USCG,,,,Requirements in this subpart do not apply to crewmembers and operators on a vessel bound for a U.S. port or place of destination under force majeure. 33:33:2.0.1.6.27.4.195.3,33,Navigation and Navigable Waters,I,P,160,PART 160—PORTS AND WATERWAYS SAFETY—GENERAL,D,Subpart D—Crewmember Identification,,§ 160.310 Definitions.,USCG,,,,"As used in this subpart, and only for purposes of this supbpart— Acceptable identification means a: (1) Passport; (2) U.S. Permanent Resident Card; (3) U.S. merchant mariner document; (4) U.S. merchant mariner credential; (5) Transportation Worker Identification Credential (TWIC) issued by the Transportation Security Administration under 49 CFR part 1572; or (6) Seafarer's Identification Document (SID) issued by or under the authority of the government of a country that has ratified the International Labour Organization Seafarers' Identity Documents Convention (Revised), 2003 (ILO 185), meeting all the requirements of ILO 185. Commercial service means any type of trade or business involving the transportation of goods or individuals, except service performed by a combatant vessel. Crewmember means all persons carried onboard a vessel to provide: navigation services; maintenance of the vessel, its machinery, or systems; arrangements essential for propulsion or safe navigation; or services for other persons onboard. Foreign vessel means a vessel of foreign registry or operated under the authority of a country except the United States. Navigable waters of the United States means the same as this term is defined in 33 CFR 2.36(a). This includes a 12-nautical-mile wide U.S. territorial sea as measured from the baseline, U.S. internal waters subject to tidal influence, and certain U.S. internal waters not subject to tidal influence. Operator means any person including, but not limited to, an owner, a charterer, or another contractor who conducts, or is responsible for, the operation of a vessel. Passport means any travel document issued by competent authority showing the bearer's origin, identity, and nationality if any, which is valid for the admission of the bearer into a foreign country. Port or place of departure means any port or place in which a vessel is anchored or moored. Port or place of destination means any port or place in which a vessel is bound to anchor or moor." 33:33:2.0.1.6.27.4.195.4,33,Navigation and Navigable Waters,I,P,160,PART 160—PORTS AND WATERWAYS SAFETY—GENERAL,D,Subpart D—Crewmember Identification,,§ 160.315 Crewmember identification requirement.,USCG,,,,"(a) A crewmember subject to this subpart must carry and present on demand an acceptable identification. An operator subject to this subpart must ensure that every crewmember on the vessel has an acceptable identification in his or her possession when the vessel is in the navigable waters of the United States. For purposes of this section, a crewmember may secure his or her acceptable identification with the vessel's master, so long as the identification can be presented on demand. (b) Compliance with the requirements in this section does not relieve vessel crewmembers and operators of any requirements under the Immigration and Nationality Act (INA) or INA implementing regulations. Likewise, compliance with INA requirements does not relieve vessel crewmembers and operators of the requirements in this section." 33:33:2.0.1.6.27.4.195.5,33,Navigation and Navigable Waters,I,P,160,PART 160—PORTS AND WATERWAYS SAFETY—GENERAL,D,Subpart D—Crewmember Identification,,§ 160.320 Sanctions and vessel control.,USCG,,,"[USCG-2007-28648, 74 FR 19140, Apr. 28, 2009, as amended by USCG-2020-0304, 85 FR 58280, Sept. 18, 2020]",Failure to comply with this subpart will subject the crewmember and operator to a civil penalty under 46 U.S.C. 70119 and the vessel to control under 46 U.S.C. 70002. 40:40:26.0.1.1.11.1.1.1,40,Protection of Environment,I,E,160,PART 160—GOOD LABORATORY PRACTICE STANDARDS,A,Subpart A—General Provisions,,§ 160.1 Scope and applicability.,EPA,,,"[73 FR 75597, Dec. 12, 2008]","(a) This part prescribes good laboratory practices for conducting studies that support or are intended to support applications for research or marketing permits for pesticide products regulated by the EPA. This part is intended to assure the quality and integrity of data submitted pursuant to sections 3, 4, 5, 8, 18 and 24(c) of the Federal Insecticide, Fungicide, and Rodenticide Act, as amended, and section 408 or 409 of the Federal Food, Drug and Cosmetic Act. (b) This part applies to any study described by paragraph (a) of this section which any person conducts, initiates, or supports on or after October 16, 1989." 40:40:26.0.1.1.11.1.1.2,40,Protection of Environment,I,E,160,PART 160—GOOD LABORATORY PRACTICE STANDARDS,A,Subpart A—General Provisions,,§ 160.3 Definitions.,EPA,,,"[54 FR 34067, Aug. 17, 1989, as amended at 72 FR 61029, Oct. 26, 2007; 73 FR 75597, Dec. 12, 2008]","As used in this part the following terms shall have the meanings specified: Application for research or marketing permit means any of the following: (1) An application for registration, amended registration, or reregistration of a pesticide product under FIFRA sections 3, 4 or 24(c). (2) An application for an experimental use permit under FIFRA section 5. (3) An application for an exemption under FIFRA section 18. (4) A petition or other request for establishment or modification of a tolerance, for an exemption for the need for a tolerance, or for other clearance under FFDCA section 408. (5) A petition or other request for establishment or modification of a food additive regulation or other clearance by EPA under FFDCA section 409 that was submitted prior to August 3, 1996. (6) A submission of data in response to a notice issued by EPA under FIFRA section 3(c)(2)(B). (7) Any other application, petition, or submission sent to EPA intended to persuade EPA to grant, modify, or leave unmodified a registration or other approval required as a condition of sale or distribution of a pesticide. Batch means a specific quantity or lot of a test, control, or reference substance that has been characterized according to § 160.105(a). Carrier means any material, including but not limited to feed, water, soil, nutrient media, with which the test substance is combined for administration to a test system. Control substance means any chemical substance or mixture, or any other material other than a test substance, feed, or water, that is administered to the test system in the course of a study for the purpose of establishing a basis for comparison with the test substance for known chemical or biological measurements. EPA means the U.S. Environmental Protection Agency. Experimental start date means the first date the test substance is applied to the test system. Experimental termination date means the last date on which data are collected directly from the study. FDA means the U.S. Food and Drug Administration. FFDCA means the Federal Food, Drug and Cosmetic Act, as amended (21 U.S.C. 321 et seq ). FIFRA means the Federal Insecticide, Fungicide and Rodenticide Act as amended (7 U.S.C. 136 et seq ). Person means an individual, partnership, corporation, association, scientific or academic establishment, government agency or organizational unit thereof, or any other legal entity. Quality assurance unit means any person or organizational element, except the study director, designated by testing facility management to perform the duties relating to quality assurance of the studies. Raw data means any laboratory worksheets, records, memoranda, notes, or exact copies thereof, that are the result of original observations and activities of a study and are necessary for the reconstruction and evaluation of the report of that study. In the event that exact transcripts of raw data have been prepared (e.g., tapes which have been transcribed verbatim, dated, and verified accurate by signature), the exact copy or exact transcript may be substituted for the original source as raw data. “Raw data” may include photographs, microfilm or microfiche copies, computer printouts, magnetic media, including dictated observations, and recorded data from automated instruments. Reference substance means any chemical substance or mixture, or analytical standard, or material other than a test substance, feed, or water, that is administered to or used in analyzing the test system in the course of a study for the purposes of establishing a basis for comparison with the test substance for known chemical or biological measurements. Specimen means any material derived from a test system for examination or analysis. Sponsor means: (1) A person who initiates and supports, by provision of financial or other resources, a study; (2) A person who submits a study to the EPA in support of an application for a research or marketing permit; or (3) A testing facility, if it both initiates and actually conducts the study. Study means any experiment at one of more test sites, in which a test substance is studied in a test system under laboratory conditions or in the environment to determine or help predict its effects, metabolism, product performance (efficacy studies only as required by 40 CFR 158.400 or 161.640, as applicable), environmental and chemical fate, persistence and residue, or other characteristics in humans, other living organisms, or media. The term “study”does not include basic exploratory studies carried out to determine whether a test substance or a test method has any potential utility. Study completion date means the date the final report is signed by the study director. Study director means the individual responsible for the overall conduct of a study. Study initiation date means the date the protocol is signed by the study director. Test substance means a substance or mixture administered or added to a test system in a study, which substance or mixture: (1) Is the subject of an application for a research or marketing permit supported by the study, or is the contemplated subject of such an application; or (2) Is an ingredient, impurity, degradation product, metabolite, or radioactive isotope of a substance described by paragraph (1) of this definition, or some other substance related to a substance described by that paragraph, which is used in the study to assist in characterizing the toxicity, metabolism, or other characteristics of a substance described by that paragraph. Test system means any animal, plant, microorganism, chemical or physical matrix, including but not limited to soil or water, or subparts thereof, to which the test, control, or reference substance is administered or added for study. “Test system” also includes appropriate groups or components of the system not treated with the test, control, or reference substance. Testing facility means a person who actually conducts a study, i.e. , actually uses the test substance in a test system. “Testing facility” encompasses only those operational units that are being or have been used to conduct studies. Vehicle means any agent which facilitates the mixture, dispersion, or solubilization of a test substance with a carrier." 40:40:26.0.1.1.11.1.1.3,40,Protection of Environment,I,E,160,PART 160—GOOD LABORATORY PRACTICE STANDARDS,A,Subpart A—General Provisions,,§ 160.10 Applicability to studies performed under grants and contracts.,EPA,,,,"When a sponsor or other person utilizes the services of a consulting laboratory, contractor, or grantee to perform all or a part of a study to which this part applies, it shall notify the consulting laboratory, contractor, or grantee that the service is, or is part of, a study that must be conducted in compliance with the provisions of this part." 40:40:26.0.1.1.11.1.1.4,40,Protection of Environment,I,E,160,PART 160—GOOD LABORATORY PRACTICE STANDARDS,A,Subpart A—General Provisions,,§ 160.12 Statement of compliance or non-compliance.,EPA,,,,"Any person who submits to EPA an application for a research or marketing permit and who, in connection with the application, submits data from a study to which this part applies shall include in the application a true and correct statement, signed by the applicant, the sponsor, and the study director, of one of the following types: (a) A statement that the study was conducted in accordance with this part; or (b) A statement describing in detail all differences between the practices used in the study and those required by this part; or (c) A statement that the person was not a sponsor of the study, did not conduct the study, and does not know whether the study was conducted in accordance with this part." 40:40:26.0.1.1.11.1.1.5,40,Protection of Environment,I,E,160,PART 160—GOOD LABORATORY PRACTICE STANDARDS,A,Subpart A—General Provisions,,§ 160.15 Inspection of a testing facility.,EPA,,,,"(a) A testing facility shall permit an authorized employee or duly designated representative of EPA or FDA, at reasonable times and in a reasonable manner, to inspect the facility and to inspect (and in the case of records also to copy) all records and specimens required to be maintained regarding studies to which this part applies. The records inspection and copying requirements should not apply to quality assurance unit records of findings and problems, or to actions recommended and taken, except that EPA may seek production of these records in litigation or formal adjudicatory hearings. (b) EPA will not consider reliable for purposes of supporting an application for a research or marketing permit any data developed by a testing facility or sponsor that refuses to permit inspection in accordance with this part. The determination that a study will not be considered in support of an application for a research or marketing permit does not, however, relieve the applicant for such a permit of any obligation under any applicable statute or regulation to submit the results of the study to EPA." 40:40:26.0.1.1.11.1.1.6,40,Protection of Environment,I,E,160,PART 160—GOOD LABORATORY PRACTICE STANDARDS,A,Subpart A—General Provisions,,§ 160.17 Effects of non-compliance.,EPA,,,,"(a) EPA may refuse to consider reliable for purposes of supporting an application for a research or marketing permit any data from a study which was not conducted in accordance with this part. (b) Submission of a statement required by § 160.12 which is false may form the basis for cancellation, suspension, or modification of the research or marketing permit, or denial or disapproval of an application for such a permit, under FIFRA section 3, 5, 6, 18, or 24 or FFDCA section 406 or 409, or for criminal prosecution under 18 U.S.C. 2 or 1001 or FIFRA section 14, or for imposition of civil penalties under FIFRA section 14." 40:40:26.0.1.1.11.2.1.1,40,Protection of Environment,I,E,160,PART 160—GOOD LABORATORY PRACTICE STANDARDS,B,Subpart B—Organization and Personnel,,§ 160.29 Personnel.,EPA,,,,"(a) Each individual engaged in the conduct of or responsible for the supervision of a study shall have education, training, and experience, or combination thereof, to enable that individual to perform the assigned functions. (b) Each testing facility shall maintain a current summary of training and experience and job description for each individual engaged in or supervising the conduct of a study. (c) There shall be a sufficient number of personnel for the timely and proper conduct of the study according to the protocol. (d) Personnel shall take necessary personal sanitation and health precautions designed to avoid contamination of test, control, and reference substances and test systems. (e) Personnel engaged in a study shall wear clothing appropriate for the duties they perform. Such clothing shall be changed as often as necessary to prevent microbiological, radiological, or chemical contamination of test systems and test, control, and reference substances. (f) Any individual found at any time to have an illness that may adversely affect the quality and integrity of the study shall be excluded from direct contact with test systems, and test, control, and reference substances, and any other operation or function that may adversely affect the study until the condition is corrected. All personnel shall be instructed to report to their immediate supervisors any health or medical conditions that may reasonably be considered to have an adverse effect on a study." 40:40:26.0.1.1.11.2.1.2,40,Protection of Environment,I,E,160,PART 160—GOOD LABORATORY PRACTICE STANDARDS,B,Subpart B—Organization and Personnel,,§ 160.31 Testing facility management.,EPA,,,,"For each study, testing facility management shall: (a) Designate a study director as described in § 160.33 before the study is initiated. (b) Replace the study director promptly if it becomes necessary to do so during the conduct of a study. (c) Assure that there is a quality assurance unit as described in § 160.35. (d) Assure that test, control, and reference substances or mixtures have been appropriately tested for identity, strength, purity, stability, and uniformity, as applicable. (e) Assure that personnel, resources, facilities, equipment, materials and methodologies are available as scheduled. (f) Assure that personnel clearly understand the functions they are to perform. (g) Assure that any deviations from these regulations reported by the quality assurance unit are communicated to the study director and corrective actions are taken and documented." 40:40:26.0.1.1.11.2.1.3,40,Protection of Environment,I,E,160,PART 160—GOOD LABORATORY PRACTICE STANDARDS,B,Subpart B—Organization and Personnel,,§ 160.33 Study director.,EPA,,,,"For each study, a scientist or other professional of appropriate education, training, and experience, or combination thereof, shall be identified as the study director. The study director has overall responsibility for the technical conduct of the study, as well as for the interpretation, analysis, documentation, and reporting of results, and represents the single point of study control. The study director shall assure that: (a) The protocol, including any change, is approved as provided by § 160.120 and is followed. (b) All experimental data, including observations of unanticipated responses of the test system are accurately recorded and verified. (c) Unforseen circumstances that may affect the quality and integrity of the study are noted when they occur, and corrective action is taken and documented. (d) Test systems are as specified in the protocol. (e) All applicable good laboratory practice regulations are followed. (f) All raw data, documentation, protocols, specimens, and final reports are transferred to the archives during or at the close of the study." 40:40:26.0.1.1.11.2.1.4,40,Protection of Environment,I,E,160,PART 160—GOOD LABORATORY PRACTICE STANDARDS,B,Subpart B—Organization and Personnel,,§ 160.35 Quality assurance unit.,EPA,,,,"(a) A testing facility shall have a quality assurance unit which shall be responsible for monitoring each study to assure management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with the regulations in this part. For any given study, the quality assurance unit shall be entirely separate from and independent of the personnel engaged in the direction and conduct of that study. The quality assurance unit shall conduct inspections and maintain records appropriate to the study. (b) The quality assurance unit shall: (1) Maintain a copy of a master schedule sheet of all studies conducted at the testing facility indexed by test substance, and containing the test system, nature of study, date study was initiated, current status of each study, identity of the sponsor, and name of the study director. (2) Maintain copies of all protocols pertaining to all studies for which the unit is responsible. (3) Inspect each study at intervals adequate to ensure the integrity of the study and maintain written and properly signed records of each periodic inspection showing the date of the inspection, the study inspected, the phase or segment of the study inspected, the person performing the inspection, findings and problems, action recommended and taken to resolve existing problems, and any scheduled date for reinspection. Any problems which are likely to affect study integrity found during the course of an inspection shall be brought to the attention of the study director and management immediately. (4) Periodically submit to management and the study director written status reports on each study, noting any problems and the corrective actions taken. (5) Determine that no deviations from approved protocols or standard operating procedures were made without proper authorization and documentation. (6) Review the final study report to assure that such report accurately describes the methods and standard operating procedures, and that the reported results accurately reflect the raw data of the study. (7) Prepare and sign a statement to be included with the final study report which shall specify the dates inspections were made and findings reported to management and to the study director. (c) The responsibilities and procedures applicable to the quality assurance unit, the records maintained by the quality assurance unit, and the method of indexing such records shall be in writing and shall be maintained. These items including inspection dates, the study inspected, the phase or segment of the study inspected, and the name of the individual performing the inspection shall be made available for inspection to authorized employees or duly designated representatives of EPA or FDA. (d) An authorized employee or a duly designated representative of EPA or FDA shall have access to the written procedures established for the inspection and may request testing facility management to certify that inspections are being implemented, performed, documented, and followed up in accordance with this paragraph." 40:40:26.0.1.1.11.3.1.1,40,Protection of Environment,I,E,160,PART 160—GOOD LABORATORY PRACTICE STANDARDS,C,Subpart C—Facilities,,§ 160.41 General.,EPA,,,,Each testing facility shall be of suitable size and construction to facilitate the proper conduct of studies. Testing facilities which are not located within an indoor controlled environment shall be of suitable location to facilitate the proper conduct of studies. Testing facilities shall be designed so that there is a degree of separation that will prevent any function or activity from having an adverse effect on the study. 40:40:26.0.1.1.11.3.1.2,40,Protection of Environment,I,E,160,PART 160—GOOD LABORATORY PRACTICE STANDARDS,C,Subpart C—Facilities,,§ 160.43 Test system care facilities.,EPA,,,,"(a) A testing facility shall have a sufficient number of animal rooms or other test system areas, as needed, to ensure: proper separation of species or test systems, isolation of individual projects, quarantine or isolation of animals or other test systems, and routine or specialized housing of animals or other test systems. (1) In tests with plants or aquatic animals, proper separation of species can be accomplished within a room or area by housing them separately in different chambers or aquaria. Separation of species is unnecessary where the protocol specifies the simultaneous exposure of two or more species in the same chamber, aquarium, or housing unit. (2) Aquatic toxicity tests for individual projects shall be isolated to the extent necessary to prevent cross-contamination of different chemicals used in different tests. (b) A testing facility shall have a number of animal rooms or other test system areas separate from those described in paragraph (a) of this section to ensure isolation of studies being done with test systems or test, control, and reference substances known to be biohazardous, including volatile substances, aerosols, radioactive materials, and infectious agents. (c) Separate areas shall be provided, as appropriate, for the diagnosis, treatment, and control of laboratory test system diseases. These areas shall provide effective isolation for the housing of test systems either known or suspected of being diseased, or of being carriers of disease, from other test systems. (d) Facilities shall have proper provisions for collection and disposal of contaminated water, soil, or other spent materials. When animals are housed, facilities shall exist for the collection and disposal of all animal waste and refuse or for safe sanitary storage of waste before removal from the testing facility. Disposal facilities shall be so provided and operated as to minimize vermin infestation, odors, disease hazards, and environmental contamination. (e) Facilities shall have provisions to regulate environmental conditions (e.g., temperature, humidity, photoperiod) as specified in the protocol. (f) For marine test organisms, an adequate supply of clean sea water or artificial sea water (prepared from deionized or distilled water and sea salt mixture) shall be available. The ranges of composition shall be as specified in the protocol. (g) For freshwater organisms, an adequate supply of clean water of the appropriate hardness, pH, and temperature, and which is free of contaminants capable of interfering with the study, shall be available as specified in the protocol. (h) For plants, an adequate supply of soil of the appropriate composition, as specified in the protocol, shall be available as needed." 40:40:26.0.1.1.11.3.1.3,40,Protection of Environment,I,E,160,PART 160—GOOD LABORATORY PRACTICE STANDARDS,C,Subpart C—Facilities,,§ 160.45 Test system supply facilities.,EPA,,,,"(a) There shall be storage areas, as needed, for feed, nutrients, soils, bedding, supplies, and equipment. Storage areas for feed nutrients, soils, and bedding shall be separated from areas where the test systems are located and shall be protected against infestation or contamination. Perishable supplies shall be preserved by appropriate means. (b) When appropriate, plant supply facilities shall be provided. As specified in the protocol, these include: (1) Facilities for holding, culturing, and maintaining algae and aquatic plants. (2) Facilities for plant growth, including, but not limited to greenhouses, growth chambers, light banks, and fields. (c) When appropriate, facilities for aquatic animal tests shall be provided. These include, but are not limited to, aquaria, holding tanks, ponds, and ancillary equipment, as specified in the protocol." 40:40:26.0.1.1.11.3.1.4,40,Protection of Environment,I,E,160,PART 160—GOOD LABORATORY PRACTICE STANDARDS,C,Subpart C—Facilities,,"§ 160.47 Facilities for handling test, control, and reference substances.",EPA,,,,"(a) As necessary to prevent contamination or mixups, there shall be separate areas for: (1) Receipt and storage of the test, control, and reference substances. (2) Mixing of the test, control, and reference substances with a carrier, e.g., feed. (3) Storage of the test, control, and reference substance mixtures. (b) Storage areas for test, control, and/or reference substance and for test, control, and/or reference mixtures shall be separate from areas housing the test systems and shall be adequate to preserve the identity, strength, purity, and stability of the substances and mixtures." 40:40:26.0.1.1.11.3.1.5,40,Protection of Environment,I,E,160,PART 160—GOOD LABORATORY PRACTICE STANDARDS,C,Subpart C—Facilities,,§ 160.49 Laboratory operation areas.,EPA,,,,"Separate laboratory space and other space shall be provided, as needed, for the performance of the routine and specialized procedures required by studies." 40:40:26.0.1.1.11.3.1.6,40,Protection of Environment,I,E,160,PART 160—GOOD LABORATORY PRACTICE STANDARDS,C,Subpart C—Facilities,,§ 160.51 Specimen and data storage facilities.,EPA,,,,"Space shall be provided for archives, limited to access by authorized personnel only, for the storage and retrieval of all raw data and specimens from completed studies." 40:40:26.0.1.1.11.4.1.1,40,Protection of Environment,I,E,160,PART 160—GOOD LABORATORY PRACTICE STANDARDS,D,Subpart D—Equipment,,§ 160.61 Equipment design.,EPA,,,,"Equipment used in the generation, measurement, or assessment of data and equipment used for facility environmental control shall be of appropriate design and adequate capacity to function according to the protocol and shall be suitably located for operation, inspection, cleaning, and maintenance." 40:40:26.0.1.1.11.4.1.2,40,Protection of Environment,I,E,160,PART 160—GOOD LABORATORY PRACTICE STANDARDS,D,Subpart D—Equipment,,§ 160.63 Maintenance and calibration of equipment.,EPA,,,,"(a) Equipment shall be adequately inspected, cleaned, and maintained. Equipment used for the generation, measurement, or assessment of data shall be adequately tested, calibrated, and/or standardized. (b) The written standard operating procedures required under § 160.81(b)(11) shall set forth in sufficient detail the methods, materials, and schedules to be used in the routine inspection, cleaning, maintenance, testing, calibration, and/ or standardization of equipment, and shall specify, when appropriate, remedial action to be taken in the event of failure or malfunction of equipment. The written standard operating procedures shall designate the person responsible for the performance of each operation. (c) Written records shall be maintained of all inspection, maintenance, testing, calibrating, and/or standardizing operations. These records, containing the dates of the operations, shall describe whether the maintenance operations were routine and followed the written standard operating procedures. Written records shall be kept of nonroutine repairs performed on equipment as a result of failure and malfunction. Such records shall document the nature of the defect, how and when the defect was discovered, and any remedial action taken in response to the defect." 40:40:26.0.1.1.11.5.1.1,40,Protection of Environment,I,E,160,PART 160—GOOD LABORATORY PRACTICE STANDARDS,E,Subpart E—Testing Facilities Operation,,§ 160.81 Standard operating procedures.,EPA,,,,"(a) A testing facility shall have standard operating procedures in writing setting forth study methods that management is satisfied are adequate to insure the quality and integrity of the data generated in the course of a study. All deviations in a study from standard operating procedures shall be authorized by the study director and shall be documented in the raw data. Significant changes in established standard operating procedures shall be properly authorized in writing by management. (b) Standard operating procedures shall be established for, but not limited to, the following: (1) Test system area preparation. (2) Test system care. (3) Receipt, identification, storage, handling, mixing, and method of sampling of the test, control, and reference substances. (4) Test system observations. (5) Laboratory or other tests. (6) Handling of test systems found moribund or dead during study. (7) Necropsy of test systems or postmortem examination of test systems. (8) Collection and identification of specimens. (9) Histopathology. (10) Data handling, storage and retrieval. (11) Maintenance and calibration of equipment. (12) Transfer, proper placement, and identification of test systems. (c) Each laboratory or other study area shall have immediately available manuals and standard operating procedures relative to the laboratory or field procedures being performed. Published literature may be used as a supplement to standard operating procedures. (d) A historical file of standard operating procedures, and all revisions thereof, including the dates of such revisions, shall be maintained." 40:40:26.0.1.1.11.5.1.2,40,Protection of Environment,I,E,160,PART 160—GOOD LABORATORY PRACTICE STANDARDS,E,Subpart E—Testing Facilities Operation,,§ 160.83 Reagents and solutions.,EPA,,,,"All reagents and solutions in the laboratory areas shall be labeled to indicate identity, titer or concentration, storage requirements, and expiration date. Deteriorated or outdated reagents and solutions shall not be used." 40:40:26.0.1.1.11.5.1.3,40,Protection of Environment,I,E,160,PART 160—GOOD LABORATORY PRACTICE STANDARDS,E,Subpart E—Testing Facilities Operation,,§ 160.90 Animal and other test system care.,EPA,,,,"(a) There shall be standard operating procedures for the housing, feeding, handling, and care of animals and other test systems. (b) All newly received test systems from outside sources shall be isolated and their health status or appropriateness for the study shall be evaluated. This evaluation shall be in accordance with acceptable veterinary medical practice or scientific methods. (c) At the initiation of a study, test systems shall be free of any disease or condition that might interfere with the purpose or conduct of the study. If during the course of the study, the test systems contract such a disease or condition, the diseased test systems should be isolated, if necessary. These test systems may be treated for disease or signs of disease provided that such treatment does not interfere with the study. The diagnosis, authorization of treatment, description of treatment, and each date of treatment shall be documented and shall be retained. (d) Warm-blooded animals, adult reptiles, and adult terrestrial amphibians used in laboratory procedures that require manipulations and observations over an extended period of time or in studies that require these test systems to be removed from and returned to their test system-housing units for any reason (e.g., cage cleaning, treatment, etc.), shall receive appropriate identification (e.g., tattoo, color code, ear tag, ear punch, etc.). All information needed to specifically identify each test system within the test system-housing unit shall appear on the outside of that unit. Suckling mammals and juvenile birds are excluded from the requirement of individual identification unless otherwise specified in the protocol. (e) Except as specified in paragraph (e)(1) of this section, test systems of different species shall be housed in separate rooms when necessary. Test systems of the same species, but used in different studies, should not ordinarily be housed in the same room when inadvertent exposure to test, control, or reference substances or test system mixup could affect the outcome of either study. If such mixed housing is necessary, adequate differentiation by space and identification shall be made. (1) Plants, invertebrate animals, aquatic vertebrate animals, and organisms that may be used in multispecies tests need not be housed in separate rooms, provided that they are adequately segregated to avoid mixup and cross contamination. (2) [Reserved] (f) Cages, racks, pens, enclosures, aquaria, holding tanks, ponds, growth chambers, and other holding, rearing and breeding areas, and accessory equipment, shall be cleaned and sanitized at appropriate intervals. (g) Feed, soil, and water used for the test systems shall be analyzed periodically to ensure that contaminants known to be capable of interfering with the study and reasonably expected to be present in such feed, soil, or water are not present at levels above those specified in the protocol. Documentation of such analyses shall be maintained as raw data. (h) Bedding used in animal cages or pens shall not interfere with the purpose or conduct of the study and shall be changed as often as necessary to keep the animals dry and clean. (i) If any pest control materials are used, the use shall be documented. Cleaning and pest control materials that interfere with the study shall not be used. (j) All plant and animal test systems shall be acclimatized to the environmental conditions of the test, prior to their use in a study." 40:40:26.0.1.1.11.6.1.1,40,Protection of Environment,I,E,160,PART 160—GOOD LABORATORY PRACTICE STANDARDS,F,"Subpart F—Test, Control, and Reference Substances",,"§ 160.105 Test, control, and reference substance characterization.",EPA,,,,"(a) The identity, strength, purity, and composition, or other characteristics which will appropriately define the test, control, or reference substance shal1 be determined for each batch and shall be documented before its use in a study. Methods of synthesis, fabrication, or derivation of the test, control, or reference substance shall be documented by the sponsor or the testing facility, and the location of such documentation shall be specified. (b) When relevant to the conduct of the study the solubility of each test, control, or reference substance shall be determined by the testing facility or the sponsor before the experimental start date. The stability of the test, control, or reference substance shall be determined before the experimental start date or concomitantly according to written standard operating procedures, which provide for periodic analysis of each batch. (c) Each storage container for a test, control, or reference substance shall be labeled by name, chemical abstracts service number (CAS) or code number, batch number, expiration date, if any, and, where appropriate, storage conditions necessary to maintain the identity, strength, purity, and composition of the test, control, or reference substance. Storage containers shall be assigned to a particular test substance for the duration of the study. (d) For studies of more than 4 weeks experimental duration, reserve samples from each batch of test, control, and reference substances shall be retained for the period of time provided by § 160.195. (e) The stability of test, control, and reference substances under storage conditions at the test site shall be known for all studies." 40:40:26.0.1.1.11.6.1.2,40,Protection of Environment,I,E,160,PART 160—GOOD LABORATORY PRACTICE STANDARDS,F,"Subpart F—Test, Control, and Reference Substances",,"§ 160.107 Test, control, and reference substance handling.",EPA,,,,"Procedures shall be established for a system for the handling of the test, control, and reference substances to ensure that: (a) There is proper storage. (b) Distribution is made in a manner designed to preclude the possibility of contamination, deterioration, or damage. (c) Proper identification is maintained throughout the distribution process. (d) The receipt and distribution of each batch is documented. Such documentation shall include the date and quantity of each batch distributed or returned." 40:40:26.0.1.1.11.6.1.3,40,Protection of Environment,I,E,160,PART 160—GOOD LABORATORY PRACTICE STANDARDS,F,"Subpart F—Test, Control, and Reference Substances",,§ 160.113 Mixtures of substances with carriers.,EPA,,,,"(a) For each test, control, or reference substance that is mixed with a carrier, tests by appropriate analytical methods shall be conducted: (1) To determine the uniformity of the mixture and to determine, periodically, the concentration of the test, control, or reference substance in the mixture. (2) When relevant to the conduct of the study, to determine the solubility of each test, control, or reference substance in the mixture by the testing facility or the sponsor before the experimental start date. (3) To determine the stability of the test, control, or reference substance in the mixture before the experimental start date or concomitantly according to written standard operating procedures, which provide for periodic analysis of each batch. (b) Where any of the components of the test, control, or reference substance carrier mixture has an expiration date, that date shall be clearly shown on the container. If more than one component has an expiration date, the earliest date shall be shown. (c) If a vehicle is used to facilitate the mixing of a test substance with a carrier, assurance shall be provided that the vehicle does not interfere with the integrity of the test." 40:40:26.0.1.1.11.7.1.1,40,Protection of Environment,I,E,160,PART 160—GOOD LABORATORY PRACTICE STANDARDS,G,Subpart G—Protocol for and Conduct of a Study,,§ 160.120 Protocol.,EPA,,,,"(a) Each study shall have an approved written protocol that clearly indicates the objectives and all methods for the conduct of the study. The protocol shall contain but shall not necessarily be limited to the following information: (1) A descriptive title and statement of the purpose of the study. (2) Identification of the test, control, and reference substance by name, chemical abstracts service (CAS) number or code number. (3) The name and address of the sponsor and the name and address of the testing facility at which the study is being conducted. (4) The proposed experimental start and termination dates. (5) Justification for selection of the test system. (6) Where applicable, the number, body weight range, sex, source of supply, species, strain, substrain, and age of the test system. (7) The procedure for identification of the test system. (8) A description of the experimental design, including methods for the control of bias. (9) Where applicable, a description and/or identification of the diet used in the study as well as solvents, emulsifiers and/or other materials used to solubilize or suspend the test, control, or reference substances before mixing with the carrier. The description shall include specifications for acceptable levels of contaminants that are reasonably expected to be present in the dietary materials and are known to be capable of interfering with the purpose or conduct of the study if present at levels greater than established by the specifications. (10) The route of administration and the reason for its choice. (11) Each dosage level, expressed in milligrams per kilogram of body or test system weight or other appropriate units, of the test, control, or reference substance to be administered and the method and frequency of administration. (12) The type and frequency of tests, analyses, and measurements to be made. (13) The records to be maintained. (14) The date of approval of the protocol by the sponsor and the dated signature of the study director. (15) A statement of the proposed statistical method to be used. (b) All changes in or revisions of an approved protocol and the reasons therefore shall be documented, signed by the study director, dated, and maintained with the protocol." 40:40:26.0.1.1.11.7.1.2,40,Protection of Environment,I,E,160,PART 160—GOOD LABORATORY PRACTICE STANDARDS,G,Subpart G—Protocol for and Conduct of a Study,,§ 160.130 Conduct of a study.,EPA,,,,"(a) The study shall be conducted in accordance with the protocol. (b) The test systems shall be monitored in conformity with the protocol. (c) Specimens shall be identified by test system, study, nature, and date of collection. This information shall be located on the specimen container or shall accompany the specimen in a manner that precludes error in the recording and storage of data. (d) In animal studies where histopathology is required, records of gross findings for a specimen from postmortem observations shall be available to a pathologist when examining that specimen histopathologically. (e) All data generated during the conduct of a study, except those that are generated by automated data collection systems, shall be recorded directly, promptly, and legibly in ink. All data entries shall be dated on the day of entry and signed or initialed by the person entering the data. Any change in entries shall be made so as not to obscure the original entry, shall indicate the reason for such change, and shall be dated and signed or identified at the time of the change. In automated data collection systems, the individual responsible for direct data input shall be identified at the time of data input. Any change in automated data entries shall be made so as not to obscure the original entry, shall indicate the reason for change, shall be dated, and the responsible individual shall be identified." 40:40:26.0.1.1.11.7.1.3,40,Protection of Environment,I,E,160,PART 160—GOOD LABORATORY PRACTICE STANDARDS,G,Subpart G—Protocol for and Conduct of a Study,,§ 160.135 Physical and chemical characterization studies.,EPA,,,,"(a) All provisions of the GLP standards shall apply to physical and chemical characterization studies designed to determine stability, solubility, octanol water partition coefficient, volatility, and persistence (such as biodegradation, photodegradation, and chemical degradation studies) of test, control, or reference substances. (b) The following GLP standards shall not apply to studies, other than those designated in paragraph (a) of this section, designed to determine physical and chemical characteristics of a test, control, or reference substance: § 160.31 (c), (d), and (g) § 160.35 (b) and (c) § 160.43 § 160.45 § 160.47 § 160.49 § 160.81(b) (1), (2), (6) through (9), and (12) § 160.90 § 160.105 (a) through (d) § 160.113 § 160.120(a) (5) through (12), and (15) § 160.185(a) (5) through (8), (10), (12), and (14) § 160.195 (c) and (d) § 160.31 (c), (d), and (g) § 160.35 (b) and (c) § 160.43 § 160.45 § 160.47 § 160.49 § 160.81(b) (1), (2), (6) through (9), and (12) § 160.90 § 160.105 (a) through (d) § 160.113 § 160.120(a) (5) through (12), and (15) § 160.185(a) (5) through (8), (10), (12), and (14) § 160.195 (c) and (d)" 40:40:26.0.1.1.11.9.1.1,40,Protection of Environment,I,E,160,PART 160—GOOD LABORATORY PRACTICE STANDARDS,J,Subpart J—Records and Reports,,§ 160.185 Reporting of study results.,EPA,,,,"(a) A final report shall be prepared for each study and shall include, but not necessarily be limited to, the following: (1) Name and address of the facility performing the study and the dates on which the study was initiated and was completed, terminated, or discontinued. (2) Objectives and procedures stated in the approved protocol, including any changes in the original protocol. (3) Statistical methods employed for analyzing the data. (4) The test, control, and reference substances identified by name, chemical abstracts service (CAS) number or code number, strength, purity, and composition, or other appropriate characteristics. (5) Stability and, when relevant to the conduct of the study the solubility of the test, control, and reference substances under the conditions of administration. (6) A description of the methods used. (7) A description of the test system used. Where applicable, the final report shall include the number of animals used, sex, body weight range, source of supply, species, strain and substrain, age, and procedure used for identification. (8) A description of the dosage, dosage regimen, route of administration, and duration. (9) A description of all circumstances that may have affected the quality or integrity of the data. (10) The name of the study director, the names of other scientists or professionals and the names of all supervisory personnel, involved in the study. (11) A description of the transformations, calculations, or operations performed on the data, a summary and analysis of the data, and a statement of the conclusions drawn from the analysis. (12) The signed and dated reports of each of the individual scientists or other professionals involved in the study, including each person who, at the request or direction of the testing facility or sponsor, conducted an analysis or evaluation of data or specimens from the study after data generation was completed. (13) The locations where all specimens, raw data, and the final report are to be stored. (14) The statement prepared and signed by the quality assurance unit as described in § 160.35(b)(7). (b) The final report shall be signed and dated by the study director. (c) Corrections or additions to a final report shall be in the form of an amendment by the study director. The amendment shall clearly identify that part of the final report that is being added to or corrected and the reasons for the correction or addition, and shall be signed and dated by the person responsible. Modification of a final report to comply with the submission requirements of EPA does not constitute a correction, addition, or amendment to a final report. (d) A copy of the final report and of any amendment to it shall be maintained by the sponsor and the test facility." 40:40:26.0.1.1.11.9.1.2,40,Protection of Environment,I,E,160,PART 160—GOOD LABORATORY PRACTICE STANDARDS,J,Subpart J—Records and Reports,,§ 160.190 Storage and retrieval of records and data.,EPA,,,,"(a) All raw data, documentation, records, protocols, specimens, and final reports generated as a result of a study shall be retained. Specimens obtained from mutagenicity tests, specimens of soil, water, and plants, and wet specimens of blood, urine, feces, and biological fluids, do not need to be retained after quality assurance verification. Correspondence and other documents relating to interpretation and evaluation of data, other than those documents contained in the final report, also shall be retained. (b) There shall be archives for orderly storage and expedient retrieval of all raw data, documentation, protocols, specimens, and interim and final reports. Conditions of storage shall minimize deterioration of the documents or specimens in accordance with the requirements for the time period of their retention and the nature of the documents of specimens. A testing facility may contract with commercial archives to provide a repository for all material to be retained. Raw data and specimens may be retained elsewhere provided that the archives have specific reference to those other locations. (c) An individual shall be identified as responsible for the archives. (d) Only authorized personnel shall enter the archives. (e) Material retained or referred to in the archives shall be indexed to permit expedient retrieval." 40:40:26.0.1.1.11.9.1.3,40,Protection of Environment,I,E,160,PART 160—GOOD LABORATORY PRACTICE STANDARDS,J,Subpart J—Records and Reports,,§ 160.195 Retention of records.,EPA,,,,"(a) Record retention requirements set forth in this section do not supersede the record retention requirements of any other regulations in this subchapter. (b) Except as provided in paragraph (c) of this section, documentation records, raw data, and specimens pertaining to a study and required to be retained by this part shall be retained in the archive(s) for whichever of the following periods is longest: (1) In the case of any study used to support an application for a research or marketing permit approved by EPA, the period during which the sponsor holds any research or marketing permit to which the study is pertinent. (2) A period of at least 5 years following the date on which the results of the study are submitted to the EPA in support of an application for a research or marketing permit. (3) In other situations (e.g., where the study does not result in the submission of the study in support of an application for a research or marketing permit), a period of at least 2 years following the date on which the study is completed, terminated, or discontinued. (c) Wet specimens, samples of test, control, or reference substances, and specially prepared material which are relatively fragile and differ markedly in stability and quality during storage, shall be retained only as long as the quality of the preparation affords evaluation. Specimens obtained from mutagenicity tests, specimens of soil, water, and plants, and wet specimens of blood, urine, feces, and biological fluids, do not need to be retained after quality assurance verification. In no case shall retention be required for longer periods than those set forth in paragraph (b) of this section. (d) The master schedule sheet, copies of protocols, and records of quality assurance inspections, as required by § 160.35(c) shall be maintained by the quality assurance unit as an easily accessible system of records for the period of time specified in paragraph (b) of this section. (e) Summaries of training and experience and job descriptions required to be maintained by § 160.29(b) may be retained along with all other testing facility employment records for the length of time specified in paragraph (b) of this section. (f) Records and reports of the maintenance and calibration and inspection of equipment, as required by § 160.63 (b) and (c), shall be retained for the length of time specified in paragraph (b) of this section. (g) If a facility conducting testing or an archive contracting facility goes out of business, all raw data, documentation, and other material specified in this section shall be transferred to the archives of the sponsor of the study. The EPA shall be notified in writing of such a transfer. (h) Specimens, samples, or other non-documentary materials need not be retained after EPA has notified in writing the sponsor or testing facility holding the materials that retention is no longer required by EPA. Such notification normally will be furnished upon request after EPA or FDA has completed an audit of the particular study to which the materials relate and EPA has concluded that the study was conducted in accordance with this part. (i) Records required by this part may be retained either as original records or as true copies such as photocopies, microfilm, microfiche, or other accurate reproductions of the original records." 46:46:6.0.1.1.3.11.1.1,46,Shipping,I,Q,160,PART 160—LIFESAVING EQUIPMENT,160.027,Subpart 160.027—Life Floats for Merchant Vessels,,§ 160.027-2 Type.,USCG,,,,"(a) Each life float must meet the requirements in subpart 160.010 of this chapter for a peripheral body type buoyant apparatus designed so that persons supported are only partially immersed (180 N (40 lb.) of buoyancy per person required). (b) [Reserved]" 46:46:6.0.1.1.3.11.1.2,46,Shipping,I,Q,160,PART 160—LIFESAVING EQUIPMENT,160.027,Subpart 160.027—Life Floats for Merchant Vessels,,§ 160.027-3 Additional requirements for life floats.,USCG,,,,"(a) Each life float must have a platform designed to drop through the center of the float, whichever way the life float is floating. A typical arrangement is shown in Figure 160.027-3(a). (b) The platform must meet the requirements of one of the following paragraphs: (1) A lattice type platform must be of western red cedar, port orford cedar, sitka spruce, northern white pine, or southern cypress slats constructed on an oak frame. The slats must have nominal cross-section dimensions not less than 90 mm (3 5/8 in.) by 9.5 mm ( 3/8 in.). The frame members must have nominal cross-section dimensions not less than 100 mm (4 in.) by 12.5 mm ( 1/2 in.). The space between adjacent slats must not exceed the width of the slats. The space between each frame member and the adjacent slat must not exceed twice the width of the slats. The platform must be riveted together at each intersection of— (i) Frame members, (ii) Slats, and (iii) Frame members and slats. (2) A plywood platform must be made of exterior or marine type plywood with surfaces that are either “A” or “B” grade as commonly designated in the plywood industry. Holes 35 mm (1 3/8 in.) to 50 mm (2 in.) in diameter must be drilled through the platform. The number of holes must be at least the number equal to (L-25) (W-25)/225, where L is the length of the platform in cm and W is the width of the platform in cm. (The formula is (L-10)(W-10)/36 where L and W are measured in inches.) The thickness of the plywood must be at least— (i) 12.5 mm ( 1/2 in.) for life floats of 10 persons capacity and under, (ii) 16 mm ( 5/8 in.) for life floats between 11 and 25 persons capacity inclusive, and (iii) 19 mm ( 3/4 in.) for life floats of 26 persons capacity and over. (3) A platform of construction differing from that described in either (1) or (2) of this paragraph will be approved if it has holes to permit the passage of water and if it passes the tests in § 160.027-7. The number of holes must be the same as required for a plywood platform. If the platform is netting on a frame, the netting must be constructed of cordage with a breaking strength of at least 1600 N (355 lb.). The netting must be constructed on not more than 5 cm (2 in.) centers and must be knotted together at each point where the lines intersect. (c) Each platform must be of a material that is resistant to deterioration by exposure to weather or must have a surface that protects it from deterioration by exposure to weather. For a wood platform, this surface must be at least two coats of water resistant spar varnish, or two coats of marine paint. (d) Each part of the platform, including surfaces, edges, and rivets must be smooth and must not have cutting edges, points, or splinters which would be dangerous for bare feet. (e) The platform must be arranged so that under normal stowed conditions, it can be retained in the center of the float and can be readily released from this position for use. (f) The platform must be suspended from the body of the float by a net or an equivalent arrangement, which when fully extended, holds the top of the platform approximately 900 mm (36 in.) below the center of the float body. (1) The net must be constructed of cordage with a minimum breaking strength of 1600 N (355 lb.). The net must be attached to the platform through holes on centers that do not exceed 165 mm (6 1/2 in.). (2) If the platform is suspended from the body of the float by an arrangement other than a net as described in paragraph (c)(1) of this section, the arrangement must be of equivalent to the net in terms of strength, resistance to tangling, and allowing the platform to freely pass through the center of the life float body." 46:46:6.0.1.1.3.11.1.3,46,Shipping,I,Q,160,PART 160—LIFESAVING EQUIPMENT,160.027,Subpart 160.027—Life Floats for Merchant Vessels,,§ 160.027-7 Pre-approval tests for alternate platform designs.,USCG,,,,"(a) The tests in this section are for life float platforms that do not meet the requirements of either § 160.027-3(b) (1) or (2). (b) The float body must be supported so that the platform is suspended in the air by the net or equivalent supporting arrangement. The platform must be loaded evenly with a weight equal to 60 percent of the weight of the total number of persons for which the float is to be rated, assuming a weight of 75 kg (165 lb.) per person. The weight must be allowed to remain on the platform for ten minutes after which it is removed. The supporting arrangement and platform must not show any evidence of damage or permanent deformation as a result of this test. (c) The float body must be supported so that the platform is suspended in the air by the net or equivalent supporting arrangement. A bag of sand, shot or similar granular material weighing 90 kg (200 lb.) must be dropped onto the center of the platform from a height of 3 m (10 ft.). The supporting arrangement and platform must not show any damage that would affect the serviceability of the float or platform. (d) As part of the buoyancy test required in § 160.010-7(e) of this chapter, the platform must be loaded with weights equal to 1/2 the rated capacity of the float. There must be no damage to the supporting arrangement or platform as a result of this test. Since the weights on the platform will be submerged during this test, allowance must be made for the displacement of the submerged weights. The weight required is calculated by the formula W = (18d)/(d-4895), where W is the required submerged weight per person (in kg) and d is the density of the material (in kg/m 3 ). (In customary U.S. units, the formula is W = 40d)/(d-63) where W is in lb. and d is in lb./ft. 3 )."