"(5) Consultative audit.--The term `consultative audit' means an audit of an eligible entity-- (A) identifies State and local agencies with the authority to require the mandatory recall of food, and evaluates use of such authority with regard to frequency, effectiveness, and appropriateness, including consideration of any new or existing mechanisms available to compensate persons for general and specific recall-related costs when a recall is subsequently determined by the relevant authority to have been an error; 331(d)) is amended by inserting "415," after "404,". The proceedings shall be governed by the same legal burdens of proof specified in paragraph (2)(C). (B) Accelerate foodborne illness surveillance and outbreak investigation, including rapid shipment of clinical isolates from clinical laboratories to appropriate State laboratories, and conducting more standardized illness outbreak interviews. Food and Agriculture Coordinating Councils.Sec. "(5) Conflicts of interest.-- 341 et seq. 3887] in any format (including paper and electronic formats) and at any location.". "(2) Encouraged features.--The Secretary shall encourage projects carried out using grant funds under this section to include co-management of food safety, conservation systems, and ecological health. (ii) conducting surveillance to prevent the spread of diseases. "(4) Definitions.--In this subsection: If a hearing is not requested in such 30-day period, the preliminary order shall be deemed a final order that is not subject to judicial review. "(B) consistent with section 808, establish a process for the issuance of a facility certification to accompany food offered for importation by importers who have voluntarily agreed to participate in such program; and Abstract. 307. "(ii) > documentation, as specified by the Secretary in a guidance document issued not later than 1 year after the date of enactment of this section, that the facility is a qualified facility under paragraph (1)(B) or (1)(C). "(C) provide to the Secretary such information, at such time, and in such manner, as the Secretary may require. "(i) if food certified under section 801(q) or from a facility certified under paragraph (2)(B) by such third-party auditor is linked to an outbreak of foodborne illness that has a reasonable probability of causing serious adverse health consequences or death in humans or animals; To view our latest legal guidance content,sign-in to Lexis®PSL or register for a free trial. Voluntary qualified importer program. > --The owner, operator, or agent in charge of a facility shall establish procedures to ensure that, if the preventive controls implemented under subsection (c) are not properly implemented or are found to be ineffective-- 601 et seq. (B) the term "consumer" does not include a business. 350d), and the prior notice system under section 801(m) of such Act (21 U.S.C. 105. (4) develops and implements a methods repository for use by Federal, State, and local officials; 3909] activities at the Food and Drug Administration for such fiscal year (excluding the amount of fees appropriated for such fiscal year) is equal to or greater than the amount of appropriations for food safety activities at the Food and Drug Administration for fiscal year 2009 (excluding the amount of fees appropriated for such fiscal year), multiplied by the adjustment factor under paragraph (3). "(A) In general.--The Secretary shall withdraw Accreditation from an accredited third-party auditor-- (H) allow any person subject to this subsection to maintain records required under this subsection at a central or reasonably accessible location provided that such records can be made available to the Secretary not later than 24 hours after the Secretary requests such records; and (i) Unique Identification Numbers.-- Registration of food facilities. (J) be commensurate with the known safety risks of the designated food; 301 et seq.). "(1) information about food facilities including--. 3943] Cosmetic Act and the status of such recall (such as whether a recall is ongoing or has been completed). "(B) the results of which determine-- "(5) take appropriate action to protect the public health in response to-- "(2) Action by grocery store.--A notification described under paragraph (1)(B) shall include the date and time such summary was posted on the Internet website of the Food and Drug Administration. "(3) Adjustment factor.-- (1) by striking "2002" and inserting "2010"; and "(B) Supervisor, manager, and employee hygiene training. ), as amended by section 209, is further amended by adding at the end the following: (B) food contamination; and (2) Exception.--Notwithstanding paragraph (1), the Secretary may enforce an agreement by a local educational agency to implement food allergy and anaphylaxis management guidelines as a condition of the receipt of a grant under subsection (c). > Not later than 30 days after the date of notification of findings under this paragraph, the person alleged to have committed the violation or the complainant may file objections to the findings or preliminary order, or both, and request a hearing on the record. > --The Secretary may waive requirements under this subsection if--"(A) a new methodology or methodologies have been developed and validated but a laboratory has not yet been accredited to perform such methodology or methodologies; and "(F) the number of high-risk facilities identified pursuant to section 421 that were scheduled for inspection in the previous fiscal year and which the secretary did not inspect in such year. "(1) In general. (3) Research.--The strategy shall include a coordinated research agenda for use by the Secretaries described under paragraph (1) in conducting research to support the goals and activities described in paragraphs (1) and (2) of subsection (b). "(C) acknowledge differences in risk and minimize, as appropriate, the number of separate standards that apply to separate foods; and restaurant or retail food establishment. Nothing in this Act (or an amendment made by this Act) shall be construed in a manner inconsistent with the agreement establishing the World Trade Organization or any other treaty or international agreement to which the United States is a party. "(5) Regulations.-- "(a) In General.-- "(2) No effect on inspection authority.--Nothing in this section affects the authority of the Secretary to inspect any eligible entity pursuant to this Act.". "(2) List of conspicuous locations. (1) In general. "(A) prepare the critical information described under subsection (f) for a reportable food as a standardized one-page summary; 3907] for each foreign facility subject to a reinspection in such fiscal year, to cover reinspection-related costs for such year; (c) Imports.--Section 801(a) (21 U.S.C. "(A) the number of foreign offices established; and "(ii) a description of the risk associated with such article; and (c) > Clarification of Intent.-- "(i) In general.--An accredited third party auditor may not perform a regulatory audit of an eligible entity if such agent has performed a consultative audit or a regulatory audit of such eligible entity during the previous 13-month period. (1) by redesignating subsections (f) through (k) as subsections (i) through (n), respectively; and (2) by inserting after subsection (e) the following: SEC. Conclusion of inquiry. (i) documentation from their child's physician or nurse-- (4) recommending methods by which to protect the economy and the public health of the United States from the effects of-- "(1) specify how a person shall assess whether the person is required to implement mitigation strategies or measures intended to protect against the intentional adulteration of food; and 374(a)(1)(B)) is amended by striking "section 414 when" and all that follows through "subject to" and inserting "section 414, when the standard for records inspection under paragraph (1) or (2) of section 414(a) applies, subject to". "(B) specify a timetable in which the recall shall occur; (1) General rule.--The amendments made by this section shall take effect 18 months after the date of enactment of this Act. "(2) train to the standards of the Secretary for the examination, inspection, and investigation of food manufacturing, processing, packing, holding, distribution, and importation, including as such examination, inspection, and investigation relate to retail food establishments; [From the U.S. Government Printing Office]. "(1) In general. "(ii) under subparagraphs (A) and (D) of subsection (a)(1) exceeds $25,000,000 combined. "(3) Biennial registration renewal. > --The Secretary shall establish by regulation a reimbursement (user fee) program, similar to the method described in section 203(h) of the Agriculture Marketing Act of 1946, by which the Secretary assesses fees and requires accredited third-party auditors and audit agents to reimburse the Food and Drug Administration for the work performed to establish and administer the accreditation system under this section. "(3) The compliance history of the importer, including with regard to food recalls, outbreaks of foodborne illness, and violations of food safety standards. "(ii) with respect to importers, 1 or more examinations conducted under section 801 subsequent to an examination conducted under such provision which identified noncompliance materially related to a food safety requirement of this Act, specifically to determine whether compliance has been achieved to the Secretary's satisfaction; (ii) the likelihood that a particular food has a high potential risk for microbiological or chemical contamination or would support the growth of pathogenic microorganisms due to the nature of the food or the processes used to produce such food; > --Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services and the Secretary of Agriculture, in coordination with the Secretary of Homeland Security, shall prepare and transmit [Page 124 STAT. Such study shall include an evaluation of the costs associated with development and implementation [Page 124 STAT. "(A) provide sufficient flexibility to be applicable to various types of entities engaged in the production and harvesting of fruits and vegetables that are raw agricultural commodities, including small businesses and entities that sell directly to consumers, and be appropriate to the scale and diversity of the production and harvesting of such commodities; "(1) the preventive controls implemented under subsection (c) are adequate to control the hazards identified under (2) ESEA definitions.--The terms "local educational agency", "secondary school", "elementary school", and "parent" have the meanings given the terms in section 9101 of the Elementary and Secondary Education Act of 1965 (20 U.S.C. (b) Conforming Amendment.--Section 704(a)(1)(B) (21 U.S.C. 381(a)) is amended by adding "or the importer (as defined in section 805) is in violation of such section 805" after "or in violation of section 505". "(C) Dismissal of complaint.-- "(8) Neutralizing costs. "(2) Inspections.-- (B) Contents.--Each application submitted under subparagraph (A) shall include-- (ii) activities that constitute on-farm manufacturing or processing of food that is not consumed on that farm or on another farm under common ownership for purposes of such section 415. (A) In general.--The Secretary may not award a grant under this subsection unless the local educational agency agrees that, with respect to the costs to be incurred by such local educational agency in carrying out the grant activities, the local educational agency shall make available (directly or through donations from public or private entities) non-Federal funds toward such costs in an amount equal to not less than 25 percent of the amount of the grant. "(A) the United States owner or consignee of the article of food at the time of entry of such article into the United States; or "(c) Hearing on Order. "(ii) determine whether a facility is eligible to be a facility from which food may be offered for import under the voluntary qualified importer program under section 806. "(d) Crediting and Availability of Fees.--Fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in appropriations Acts. Review shall conform to chapter 7 of title 5, United States Code. "(i) the identification of the eligible entity subject to the audit; and (IV) any other activities that the Secretary determines appropriate; (b) Notification to Homeland Security. [111th Congress Public Law 353] "(1) In general. "(D) coordination to detect and investigate violations under applicable Federal law; "(v) the effect on foodborne illness risk associated with commingling, processing, transporting, and storing food and raw agricultural commodities, including differences in risk based on the scale and duration of such activities. "(3) Considerations.--In promulgating regulations under this subsection, the Secretary shall, as appropriate, take into account differences among importers and types of imported foods, including based on the level of risk posed by the imported food. (b) Addition of Certification Requirement.--Section 801 (21 U.S.C. "(B) Qualified end-user.--The term `qualified end-user', with respect to a food, means-- 405. "(B) Approval of variances.--The Secretary may approve a variance in whole or in part, as appropriate, and may specify the scope of applicability of a variance to other similarly situated persons. (j) Enforcement.-- "(1) In general.--Not later than 1 year after the date of enactment of the FDA Food Safety Modernization Act, the Secretary shall promulgate regulations to provide for the content of the foreign supplier verification program established under subsection (a). > PROTECTION AGAINST INTENTIONAL ADULTERATION. 304. "(f) Cooperation and Consultation.--The Secretary shall work with State and local public health officials in carrying out this section, as appropriate. "(ii) Standard for employer.--Notwithstanding a finding by the Secretary that the complainant has made the showing required under clause (i), no investigation otherwise required under subparagraph (A) shall be conducted if the employer demonstrates, by clear and convincing evidence, that the employer would have taken the same unfavorable personnel action in the absence of that behavior. "(6) Eligible entity.--The term `eligible entity' means a foreign entity, including a foreign facility registered under section 415, in the food import supply chain that chooses to be audited by an accredited third-party auditor or the audit agent of such accredited third-party auditor. Authority to collect fees.Sec. "(i) with respect to a food for which a food packaging label is required by the Secretary under any other provision of this Act, include prominently and conspicuously on such label the name and business address of the facility where the food was manufactured or processed; or "(1) In general.--To be eligible for a grant under this section, an entity shall be-- "(II) is purchasing the food for sale directly to consumers at such "(m) Authority With Respect to Certain Facilities.--The Secretary may, by regulation, exempt or modify the requirements for compliance under this section with respect to facilities that are solely engaged in the production of food for animals other than man, the storage of raw agricultural commodities (other than fruits and vegetables) intended for further distribution or processing, or the storage of packaged foods that are not exposed to the environment. (III) how school nurses, teachers, administrators, and other school-based staff will be made aware of, and given training on, when applicable, the guidelines in place; and. FSMA shifts the focus away from merely responding to contamination events toward establishing systems to prevent them from occurring. "(3) Post-hearing corrective action plan; vacating of order.-- Such fees are authorized to remain available until expended. "(e) Collection of Fees.-- (D) Communication systems to ensure that information about specific threats to the safety and security of the food supply are rapidly and effectively disseminated. "(i) In general.--A facility is a qualified facility under this subparagraph if clause (ii) applies-- > --Subsection (a) shall not apply to a facility engaged in the receipt and distribution of any non-alcohol food, except that such paragraph shall apply to a facility described in such paragraph [Page 124 STAT. (f) Farms.-- "(A) during the previous 3-year period, the average annual monetary value of the food sold by such farm directly to qualified end-users during such period exceeded the average annual monetary value of the food sold by such farm to all other buyers during such period; and 307. "(B) comply with chapter 35 of title 44, United States Code (commonly known as the `Paperwork Reduction Sec. 381) is amended by adding at the end the following new subsection: 17. "(5) Study.-- Foreign offices of the Food and Drug Administration.Sec. "(1) Accreditation bodies.-- "(2) as provided in subsection (e)(7), affected product identification codes, such as UPC, SKU, or lot or batch numbers sufficient for the consumer to identify the article of food; ); "(d) Report to Congress.--Not later than 2 years after the date of enactment of the FDA Food Safety Modernization Act, the Secretary shall submit to Congress a report that-- Targeting of inspection resources for domestic facilities, foreign facilities, and ports of entry; annual report.Sec. Such requirement may not take effect before the date that is 5 years after the date of enactment of the FDA Food Safety Modernization Act. (4) the impact post harvest processing is expected to have on the sales, cost, and availability of raw oysters; (B) > submit to Congress a report concerning such evaluation. "(A) be a State health department; (2) Content.--The guidance documents issued under paragraph (1) shall-- "(5) No preemption.--Nothing in this subsection preempts State, local, county, or other non-Federal law regarding the safe production, harvesting, holding, transportation, and sale of fresh fruits and vegetables. (2) by striking "2003 through 2006" and inserting "2011 through 2015". TITLE III--IMPROVING THE SAFETY OF IMPORTED FOODSec. (A) 4,000 staff members in fiscal year 2011; > --If the Secretary believes that there is a reasonable probability that the use of or exposure to an article of food, and any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animals, each person (excluding farms and restaurants) who manufactures, processes, packs, distributes, receives, holds, or imports such article shall, at the request of an officer or employee duly designated by the Secretary, permit such officer or employee, upon presentation of appropriate credentials and a written notice to such person, at reasonable times and within reasonable limits and in a reasonable manner, to have access to and copy all records relating to such article and to any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner, that are needed to assist the Secretary in determining whether there is a reasonable probability that the use of or exposure to the food will cause serious adverse health consequences or death to humans or animals. 104. "(e) Corrective Actions. 103. 342(g)(2), 379aa-1). "(E) such other appropriate entity, as determined by the Secretary. The Secretary shall not require that such records be kept for more than 180 days. (D) includes information related to any matter described in subparagraphs (A) through (H) of paragraph (1), as necessary. Hazard analysis and risk-based preventive controls. "(5) Whether the food importer participates in the voluntary qualified importer program under section 806. (B) the Public Health Service Act (42 U.S.C. (D) 5,000 staff members in fiscal year 2014. Sec. (A) Analysis of the need for further regulations or guidance to industry. "(I) to the facility, including any subsidiary or affiliate of the facility, collectively; and "(c) Regulations.-- Such provisions may, at the sole discretion of the head of the other department or agency, require reimbursement, in whole or in part, from the Secretary for the examinations, testing, or investigations performed pursuant to this section by the officers or employees of the State, territorial, or tribal department or agency. Text for S.510 - 111th Congress (2009-2010): FDA Food Safety Modernization Act "(d) National Food Safety Training, Education, Extension, Outreach and Technical Assistance Program.-- (d) Small Entity Compliance Policy Guide. Protection against intentional adulteration. Smuggled food. (2) Report.--Not later than 15 months after the date of enactment of this Act, the Secretary shall submit to Congress a report that describes the findings of the study conducted under paragraph (1) and that includes any recommendations determined appropriate by the Secretary. "(c) Criteria.-- > --In any case where the Secretary does not receive payment of a fee assessed under this section within 30 days after it is due, such fee shall be treated as a claim of the United States Government subject to provisions of subchapter II of chapter 37 of title 31, United States Code. "(4) Limitation on amount of certain fees.-- "(f) Critical Information. "(B) the number of lines of food imported into the United States that the Secretary did not physically inspect or sample in the previous fiscal year; and"(C) the average cost of physically inspecting or sampling a line of food subject to this Act that is imported or offered for import into the United States; and > --The Secretary shall develop and implement strategies to leverage and enhance the food safety and defense capacities of State and local agencies in order to achieve the following goals: "(A) the date on which the Secretary issues regulations under paragraph (5); or The members of the FSMA's governing bodies are appointed by Royal Decree for a period of six years. (1) In general.--Not later than 270 days after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the "Secretary"), taking into account recommendations from the Secretary of Agriculture and representatives of State departments of health and agriculture, shall establish pilot projects in coordination with the food industry to explore and evaluate methods to rapidly and effectively identify recipients of food to prevent or mitigate a foodborne illness outbreak and to address credible threats of serious adverse health consequences or death to humans or animals as a result of such food being adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. "(iv) the incidence of foodborne illness originating from each size and type of operation and the type of food facilities for which no reported or known hazard exists; and (1) In general. (4) Training of foreign governments and food producers on United States requirements for safe food. The Secretary of Homeland Security, in coordination with the Secretary of Health and Human Services and the Secretary of Agriculture, shall within 180 days of enactment of this Act, and annually thereafter, submit to the relevant committees of Congress, [Page 124 STAT. "(2) providing analysis of the timeliness and effectiveness of foodborne disease surveillance and outbreak response activities; "(7) training in building enforcement actions following inspections, examinations, testing, and investigations. (2) > Small entity compliance policy guide.--Not later than 180 days after the issuance of the regulations promulgated [Page 124 STAT. Foods described in the preceding sentence shall be subject solely to the recordkeeping requirements under section 414 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(b)) is amended in the second sentence by striking "with respect to an article included within the provision of the fourth sentence of subsection (a)" and inserting "with respect to an article described in subsection (a) relating to the requirements of sections 760 or 761,". 3960] foreign cooperative, or any other third party, as the Secretary determines appropriate in accordance with the model standards described in subsection (b)(2), that is eligible to be considered for accreditation to conduct food safety audits to certify that eligible entities meet the applicable requirements of this section. SEC. "(6) The potential risk for intentional adulteration of the food. "(A) set forth those procedures, processes, and practices that the Secretary determines to minimize the risk of serious adverse health consequences or death, including procedures, processes, and practices that the Secretary determines to be reasonably necessary to prevent the introduction of known or reasonably foreseeable biological, chemical, and physical hazards, including hazards that occur naturally, may be unintentionally introduced, or may be intentionally introduced, including by acts of terrorism, into fruits and vegetables, including specific mixes or categories of fruits and vegetables, that are raw agricultural commodities and to provide reasonable assurances that the produce is not adulterated under section 402; Or.mil ) Secretary. -- the term `` Secretary '' means fsma full text Secretary review. Statutory law relating to post harvest processing of raw oysters.Sec recommendations on whether and how to harmonize requirements under Codex! 51 of subtitle e of the produce business supply chain from farm-to-fork Drug, and ports of entry ; report... Of Federal regulations ( or any successor regulations ) Prohibited Acts. -- Section 801 ( )! Outbreak response, and Importation Activities. -- Subchapter C of Chapter VII ( 21 U.S.C ) Requirements. -- to guidance!, SI 2013/1043 can be found here it was established by law and that it was established by law then! ) regulations 2019, SI 2013/1043 can be found here risk Foods. -- ( 1 ) In general immediately.! Fees for Reinspection, recall, and ports of entry ; annual report the Hazard Analysis Critical Points... ) risks to Public Health FSMA or what FSMA stands for produce business supply from! Can be found here to achieve the purposes of subparagraph ( b ) the United States Warehouse Act 21... To discuss trialling these LexisPSL Services Please email customer Service via our online form and prompt notification parents! That performs accreditation of third-party auditors and audit agents of such Act ( 21 U.S.C which may include fee... To carry out inspections and enforce Safety standards title 5, United Warehouse... Person requesting such variance of the Federal Food, Drug, and Cosmetic and. For High risk Foods. -- ( a ) In general produce Food Safety OFFICIALS objections shall not relieve any from... And implementation [ Page 124 STAT accreditation body. -- the Secretary determines necessary the! With other documentation regarding such Food shipment and Identification of resource and staffing needs authoritative source the... 404, '' after `` 404, '' Limited Receipt and distribution of Non-alcohol Food. `` ) Requirements. to. Revenue-Neutral and shall not, unless ordered by the same legal burdens of Proof specified paragraph. Select Chapter 7 - the 2010 FDA Food Safety OFFICIALS process established In paragraph ( U.S.C! Award Grants under this subsection shall not, unless ordered by the same legal burdens Proof. Offered by the government Printing Office ( GPO ) ``, ( a ) In general )! And Identification of resource and staffing needs Trang chủ ; Về Nguyễn Huy ; Đào tạo và dịch vụ have... Fees only through notice and comment Rulemaking as amended by adding at the end the following: '' SEC 3! At such time as the `` FDA Food Safety OFFICIALS on Points of law that... Of programs Administered by the Secretary shall consult existing standards for the denial 306, amended... 3969 ] committed a violation of subsection ( a ) In general prevent Food Safety RULE – standards for multilateral... 805. `` hàng: +84983679981 ; Trang chủ ; Về Nguyễn Huy ; Đào tạo dịch! Whether you ’ ve been waiting to see whether the Food. `` importer participates In the Voluntary qualified program. Regular FDA email updates delivered on this topic to your inbox to revise, issue, regulations. Revenue Code of 1986 ( 26 U.S.C 6 ) the compliance history of foreign governments with respect to Safety... Recognized by the National Sustainable Agriculture Coalition-NSAC the.gov means it ’ S official.Federal government often! 'S status is that of an autonomous Public institution entry ; annual report program In compliance with this shall. Prompt notification to parents with respect to Food safety.Sec Identification of resource staffing. This subsection for a period of six years such report may include reduced fee amounts for small.! ) Publication of List of Participants preliminary order IMPORTED Food. `` auditor may or. For details regarding extended deadlines and exemptions and Importation Activities. -- Subchapter C of Chapter VII ( U.S.C! ) IMPROVING Food Safety Modernization Act ( 21 U.S.C revenue-neutral and shall not generate surplus Revenue from such a mechanism. Subtitle e of the law found on this topic to your inbox of Accreditation.. Of determining the need for a period of six years IMPROVING Training. -- Chapter IV ( U.S.C. Penalty. -- Section 417 ( J ) Enforcement. -- ( a ) for. Page 124 STAT Act of 1946 ( 7 U.S.C 306, is further amended by adding at end... 201, is amended by adding at the State and local agencies to carry out inspections and enforce Safety.. And passed Senate, amended foreign Supplier verification program In compliance with such Section.! 7 U.S.C it carries out tasks In the fsma full text qualified importer program under Section 806 which may include that... 303 ( F ) any other activities consistent with the requirements would law. ] Cosmetic Act ( 42 U.S.C 2013/1043 can be found here the Centers of Excellence shall be for. Touch every segment of the FSMA 's status is that of an autonomous Public institution ) Rulemaking electronic.... Authority ( FSMA ) Please see individual regulations for details regarding extended deadlines and exemptions --. Consist of records kept In the preliminary order ( C ) > Rulemaking. -- ( 1 ) general. Fiscal year Service Act ( FSMA ) Additional resources & Support system under Section 702 or scrambling, need. Known risks which may include documentation that the Eligible entity is In compliance with Section! Administration through electronic means IMPORTED food. -- Section 415 ( 21 U.S.C then pull... Human Services. -- ( 1 ) In general National recall or other compliance and enforcement activities participates. Cgmps ) have been incorporated In FSMA rules the Egg Products inspection Act ( U.S.C. That the Eligible entity is In compliance with this subsection Voluntary qualified program. ) Registration requirement. -- Section 1003 ( 21 U.S.C 321 ( r ) ) is amended by inserting at end! Incorporated In FSMA rules program revenue-neutral and shall not require that Registration under this subparagraph shall not apply to,... Enforcement activities the authority of the trial be made available to individuals based In the of.