| | Update AppendixFollowing is a detailed summary of additional steps underway to implement the Action Plan. Recommendation #1: Create new and strengthen existing standards.Accomplishments Developed a common set of risk assessment tools - The Health Working Group of the Security and Prosperity Partnership (SPP) developed a pathway to achieving a common set of risk assessment tools for food allergens, intended to identify products that may pose a high risk to the health and safety of North American consumers. Signed MOA with China to improve the safety of imported products - HHS established two Memoranda of Agreement (MOA) with the Chinese government, and has begun to aggressively implement those agreements. Share self assessment tools - HHS worked domestically with industry to strengthen existing safety standards by releasing self assessment tools for firms to minimize the risk of intentional contamination of food and cosmetics. MOUs on product safety - In January 2008, the CPSC signed a Memorandum of Understanding (MOU) with its counterpart agency in Vietnam, the Directorate for Standards and Quality of the Socialist Republic of Vietnam, to bring its total number of product safety MOUs to 15. These include Canada, China, European Commission, Israel, South Korea, Peru, Chile, Costa Rica, India, Japan, Mexico, Taiwan (Taipei Economic and Cultural Representative Office), Egypt, Columbia, and Vietnam. Disseminate “Manufacturing Safer Consumer Products” - CPSC recently added a link to the Chinese version of the handbook “Manufacturing Safer Consumer Products” on its website and is also actively disseminating the handbook throughout China to key trade associations and industry groups.
Looking Ahead Collaborate with International Partners - In the months ahead, HHS/FDA will also continue to collaborate with international partners on import safety standards, including developing an affirmative work plan with the Canadian Food Inspection Agency on agreed upon elements of food safety, including risk mapping, track and trace, and information sharing. Joint outreach with the European Commission - In September 2008, CPSC and European Commission officials will jointly conduct outreach events in China on toy, electrical products and clothing/textile safety. Outreach to manufacturers, importers and foreign officials - CPSC staff is continuing to conduct multiple outreach/training events for Chinese and Vietnamese manufacturers, U.S. importers and foreign officials and will seek opportunities for outreach to other significant supplier countries throughout the remainder of 2008. Product Safety Summit - CPSC is preparing for the third biennial U.S.-Sino Product Safety Summit in 2009. Promote “Manufacturing Safer Consumer Products” - Throughout 2008, the CPSC will expand promotion of both English and Chinese versions of “Manufacturing Safer Consumer Products.”
Recommendation #2: Verify Compliance of Foreign Producers with United States Safety and Security Standards through CertificationAccomplishments Develop third-party certification programs - HHS/FDA has begun work with Chinese regulatory authorities to implement the memoranda of agreement and held the first bilateral talks with Chinese regulatory agencies to work towards creation of a certification program to help ensure items exported to the United States meet HHS/FDA safety standards. For SFDA, two high level meetings have been held since the December signing. Implementing ISA import safety component - CBP has taken the guidance of representatives from the trade community and is currently in the development phase, utilizing the Importer Self-Assessment (ISA) program and implementation of import safety component. The expansion of these programs is being conducted along with the cooperation and consultation of CPSC. Consider third-party certification programs - HHS/FDA is also investigating options for using third party certification programs to improve import safety. HHS/FDA sought public comment on the existence and use of third-party certification programs to better understand how they can help ensure food products are safe, secure, and meet HHS/FDA requirements. Collaborate on food safety issues - HHS/FDA and the National Oceanic and Atmospheric Administration (NOAA) are discussing ways in which the agencies can collaborate on food safety issues, including how information from inspections, conducted by NOAA’s Seafood Inspection Program can be used as a third party certification.
Looking Ahead Implement MOAs - HHS/FDA will continue to work with Chinese regulatory agencies to implement the memoranda of agreement. Information continues to be shared, and discussions continue on the program to register all companies manufacturing and exporting designated products. Standards for the registration–certification program for aquaculture and ingredients, the first phase of implementation, are being discussed. A timeline and work plan will be established with a goal of standing up the program in 2009. Implement MOAs - HHS/FDA will be building on the progress made by the memoranda of agreement with China, by developing a work plan to implement the agreement and continuing discussions with the Chinese on counterfeit drugs and ingredients in food and feed. Secure Supply Chain pilot program - HHS/FDA expects to undertake a Secure Supply Chain pilot program to expedite the entry of drug products from firms that adequately control risks posed to their products throughout their chain of supply. Verify registration data - HHS/FDA plans to establish contract relationships with non-government organizations that have a foreign office that can verify the registration data of foreign firms shipping regulated products to the U.S. Sponsor toy safety initiative - In APEC, the United States is sponsoring a toy safety initiative that will bring together regulators and private sector interests for a series of events between 2009 and 2010 to discuss regional best practices for toy safety systems. Support Product Safety Grant to Natural Products Association (NPA) - The Commerce Department’s International Trade Administration (ITA) will continue to support a grant made to NPA (representing U.S. manufacturers of dietary and nutritional supplements) to develop a testing and certification program designed to insure that the raw material ingredients sourced from China and processed into finished goods in the U.S. are safe and meet U.S. FDA Good Manufacturing Practices standards. Explore MOU with China on Seafood Safety - NOAA will continue discussion with Chinese government on an MOU regarding seafood quality and safety. The MOU under discussion covers training activities, information sharing, improved laboratory methods and practices, and traceback assistance. Expand Overseas Presence of NOAA Seafood Inspection Program - NOAA is working to place inspection personnel in specific locations such as Hong Kong, to assist the buyer-supplier relationship by inspecting the load as it is containerized and determining compliance prior to shipment.
Recommendation #3: Promote Good Importer Practices.Accomplishments Finalized guidance document for chemical imports - In April 2008, the EPA finalized and made publicly available a guidance document, the Toxic Substances Control Act (TSCA) Section 13 Import Compliance Checklist. The Checklist provides a roadmap to help chemical importers determine how to certify their chemical imports for compliance with TSCA section 13 regulatory requirements and also helps federal government inspectors better understand the Act’s import requirements. TSCA section 13 requirements help ensure that chemicals imported into the United States are in compliance with other TSCA provisions to prevent unreasonable risk of injury to human health and the environment. Create Chinese language video on importer best practices - CPSC posted a Chinese language training video on importer and supplier best practices on its website. Educate importers - CPSC representatives have been educating importers and trade groups on safety standards. Draft recommended best practices - The National Highway Traffic Safety Administration (NHTSA) has drafted industry specific Recommended Best Practices for Importers of Motor Vehicles and Motor Vehicle Equipment.
Looking Ahead Guidance on Good Importer Practices - An interagency team is in the process of developing draft guidance on good importer practices for public comment. This guidance when finalized would facilitate importer compliance with federal laws and regulations. Recommended Best Practices - NHTSA plans to publish its industry specific Recommended Best Practices as guidance. Good Importer Practices and Audits - CBP and CPSC are reviewing new operational and legal authority issues in the development of good importer practices and shared audit approach.
Recommendation #4: Strengthen Penalties and Take Strong Enforcement Actions to Ensure Accountability.Accomplishments Enforce federal air pollution standards - FDA published two Federal Register (FR) notices pursuant to section 913 of the FDA Amendments Act of 2007 to seek public comment on standards for pharmaceutical serialization, track and trace, and authentication, as well as to seek public comment on technologies used for track and trace and authentication of pharmaceuticals. Track-and-trace technologies can be used as anti-counterfeiting and anti-diversion tools by tracking a product throughout the supply chain approximately $5 million on projects to reduce air pollution. The agreement also requires companies to implement robust compliance assurance programs. Enforce lead standards - In March 2008, the CPSC announced that a manufacturer of athletic shoes and apparel agreed to pay the government a $1,000,000 civil penalty. It is the largest for a Federal Hazardous Substances Act (FHSA) violation and settled allegations that the U.S. firm imported and distributed charm bracelets manufactured in China that contained toxic levels of lead. The charm bracelets were provided as free gifts with the purchase of various styles of children’s footwear. Take enforcement action against companies for tainted pet food - In February 2008, DOJ announced the indictment of two Chinese businesses and their top executives, along with a U.S. company and its owners, for their roles in manufacturing and importing a tainted ingredient used to make pet food, which resulted in the death and serious illness of pets in the United States last year. Enforce food safety - DOJ has recently announced the arrest of two Chicago executives of a German-based food ingredients company on federal charges for allegedly conspiring to illegally import honey from China that was falsely identified as coming from other countries in order to avoid anti-dumping duties, and that was adulterated because it contained an antibiotic not approved for use in food producing animals, including bees. According to the charges, a confidential informant who worked for the company recently told U.S. Immigration and Customs Enforcement agents that it was common knowledge among company executives, including one of the defendants, that shipments of imported honey frequently were contaminated with antibiotics that were banned by the Food and Drug Administration. If convicted, the conspiracy charge carries a maximum penalty of five years in prison and a $250,000 fine.
Looking Ahead Strengthen mitigation guidelines - CBP is taking efforts to strengthen its mitigation guidelines to further improve its efforts to safeguard the public health and safety from unsafe importations. Strengthen compliance - CBP is taking steps to consider merchandise that is not in compliance with laws relating to health, safety, or conservation as an aggravating factor in the processing of violations.
Recommendation #5: Make Product Safety An Important Principle of our Diplomatic Relationships with Foreign Countries and Increase the Profile of Relevant Foreign Assistance Activities.Accomplishments Integrate import safety into international dialogues - Import safety has been integrated into the agendas of a broad range of international dialogues, including the Security and Prosperity Partnership of North America, Asia Pacific Economic Cooperation, the Association of South East Asian Nations, the Strategic Economic Dialogue with China, the U.S. – EU High Level Regulatory Cooperation Forum and Transatlantic Economic Council, and several other bilateral and multilateral dialogues. Participate in international discussions - The U.S. also discusses import safety in bilateral dialogues with individual countries, on a regional basis under the NAFTA Technical Working Group on Pesticides, and in international organizations such as the UN and the Organization for Economic Cooperation and Development. Participate in international discussions - The Department of State, its interagency partners, and international organizations are working to harmonize and improve science-based food safety standards through the World Animal Health Organization, Codex Alimentarius, and the International Plant Protection Committee. Participate in international discussions - The United States also discusses import safety in bilateral dialogues with individual countries and in international organizations such as the United Nations and the Organization for Economic Cooperation and Development. Sign MOAs on food and feed - HHS signed binding memoranda of agreement with its Chinese counterparts, and is working to implement those agreements. Sign Letters of Intent on pesticide regulation - In November 2007, the Environmental Protection Agency and China’s Institute for the Control of Agrichemicals, Ministry of Agriculture (ICAMA) signed a Letter of Intent to develop a program of cooperative activities on regulation and management of pesticides. Develop study tour and training - In April 2008, EPA and ICAMA developed a work plan for a comprehensive program on pesticide regulation and risk assessment. The initial study tour by ICAMA officials to the U.S intended to serve as a basis for future training was scheduled for May, but postponed due to ICAMA’s earthquake relief work. Subsequently, reciprocal visits by China’s ICAMA officials to the U.S., and EPA officials to Beijing, have been tentatively scheduled for October, November 2008. Participate in international discussions - In April 2008, CBP participated in the EU Customs’ Seminar on Preventing Imports of Dangerous Products. The seminar included discussion and presentations by the EU Member States and other countries including the United States and working group sessions designed to address three specific topics: 1) enhancing the cooperative network between Customs and Market Surveillance authorities, 2) Improving risk management, 3) Sharing experience, knowledge and best practice on cooperation and controls. Provide training to the Chinese on regulatory requirements - HHS/FDA provided training to the Chinese government on regulatory requirements for marketing a device in the United States. HHS/FDA also provided an overview to the Chinese of Good Manufacturing Practices and the International Conference on Harmonization, and an overview on food allergenicity. HHS/FDA has received a request to provide the Chinese with information on risk assessment methods for food ingredients. Technical Assistance on Seafood Safety - NOAA Seafood Inspection Program has provided, and continues to provide, training and consultation in response to private sector, academic and government requests in such countries as Mexico, China, India, Thailand, Papua New Guinea, Indonesia, Philippines, Peru, Singapore, and Vietnam and has worked many times with APEC on such activities. Participate in international discussions - HHS/FDA met with a Chinese delegation to discuss facilitation of inspecting Chinese firms. Sign MOU on human health and the environment - On December 13, 2007, EPA and AQSIQ signed a Memorandum of Understanding (MOU) on cooperation to protect human health and the environment in the field of imported and exported products. It established a working group to promote compliance with environmental requirements for traded products. On December 14, 2007, EPA signed an Annex to the EPA-Ministry of Environmental Protection MOU on environmental law development, implementation and enforcement to protect human health and the environment. The working group had meetings in DC and Beijing and developed a work plan and specific implementation plan. Coordinate with the Chinese - EPA and AQSIQ established working groups and action plans. CPSC officials meet monthly with AQSIQ officials (via videoconference or in person) to discuss the latest product recall issues and specific instances where AQSIQ can be helpful in improving compliance with safety standards. The meetings are also an opportunity to coordinate training and information exchange under the work plans for fireworks, toys, lighters and electrical products. Translate materials on imports into Chinese - As part of the EPA-AQSIQ MOU, EPA has committed to translate the contents and related materials on the border assistance center website http://www.bordercenter.org into Chinese, to include materials about Chinese imports on the website, and to develop a communications plan for reaching stakeholders which may include webinars or other tools. Translate materials on imports into Chinese - The CPSC created a Chinese language page on the CPSC website in 2008, and in the future will also provide links to foreign language materials for significant supplier countries such as Vietnam and Spanish-speaking countries. The CPSC staff has also worked with the National Institute of Standards and Technology (NIST) and the American National Standards Institute (ANSI) to translate U.S. product safety standards into Chinese. Electronic training on imports of ozone depleting substances - In May 2008, the U.S. adopted the public version of an electronic training module, North American Development of Enforcement Training to Ensure Legal imports of Ozone Depleting Substances. Mexico and Canada have similar versions of the Ozone Depleting Substances training module, appropriately reflecting their laws and authorities. Participate in international discussions - An HHS/FDA delegation visited Indian counterparts to discuss an HHS/FDA presence in India. Results are promising for future collaboration. Coordinate information across North America - The Security and Prosperity Partnership of North America Health Working Group developed mechanisms to coordinate and exchange information on food safety investigations and follow-up activities, including test results and recalls, in response to food safety issues that may affect another trilateral partner, such as updating the HHS-Canadian food Inspection Agency information-sharing agreement, and the HHS-Health Canada MOU. Exchange information across North America - On June 23, the first meeting of the NAFTA Import Safety Initiative was held in Washington, D.C. An analysis of existing measures on import safety was undertaken, with the intention of determining what needs to be enhanced to ensure safety and quality of pesticide products traded in North America, and between North America and the rest of the world. Exchange timely information across North America - Monthly trilateral consumer products conference calls were established to exchange timely information on product safety issues affecting the North American market, including significant recalls, technical news, and opportunities for exchange and training of personnel. Participate in international discussions - At the November 2007 High Level Regulatory Cooperation Forum, representatives of the EU and the United States discussed the need to intensify cooperation relating to the safety of imported consumer products. The TEC meeting of November 9, 2007 endorsed this initiative. To that end, the Forum discussed the final report “Toward Enhanced Co-operation Between the European Union and the United States of America on the Safety of (Imported) Products” at its meeting on April 25, 2008, and delivered the final report to the TEC on May 13, 2008. This joint report identified possibilities for and constraints to better transatlantic information sharing in the field of product safety (with particular emphasis on safety concerns arising from imported products) in the following product areas: motor vehicles, pharmaceuticals, cosmetics, toys, electrical equipment for consumer use, and food. Sponsor workshop on food safety risk communications - The United States cosponsored with the Philippines an APEC workshop on food safety risk communications practices in Manila this June.
Looking Ahead Collaborate with China - EPA will continue collaborations with China’s ICAMA, develop a work plan for 2008-2009, and organize a symposium on pesticide assessment, regulation and management in Beijing. Also, EPA will continue to work cooperatively with the Chinese Ministry of Environmental Protection to implement an MOU Annex on environmental law development, implementation and enforcement, including the delivery of training, hosting of long term visits and extended study tours, contributions to comparative research and the conduct of three pilot projects. Expand international agreements - Pursuant to the SPP, HHS/FDA plans to expand the scope of existing agreements with Canada to include food and natural health products, draft enhanced information sharing procedures for food investigations, and meet with Mexico to develop similar strategies for increased work on food safety. Participate in anti-counterfeiting activity - HHS/FDA will continue participating in pharmaceutical anti-counterfeiting activity under the United States-India High Technology Cooperation Group’s Biotechnology & Life Sciences Working Group. Build regulatory capacity - HHS/FDA will continue building regulatory capacity and providing technical assistance to foreign governments and organizations, including but not limited to participating in the U.S.-China Joint Commission on Commerce and Trade Pharmaceutical and Medical Device Task Force groups, holding a forum on international drug regulatory authorities, and holding training activities for the Chinese and Costa Rican governments. Sponsor colloquium - The U.S. Codex Office, including technical experts from USDA and the Department of Commerce, is sponsoring a colloquium in Guatemala in June 2008 so that the United States and countries from Latin America and the Caribbean can exchange views about the Codex Alimentarius Commission meeting as well as discuss training needs and to build the institutional capacity of other countries to use Codex standards and guidance. Countries include Argentina, Colombia, Costa Rica, Dominica, Dominican Republic, Guatemala, Mexico, Nicaragua, Paraguay, Peru, and Uruguay. Conduct seminars for foreign inspection officials - FSIS will conduct three International Meat and Poultry Inspection Seminars in fiscal year 2008 for inspection officials from other countries, with the goal to present U.S. meat and poultry Hazard Analysis Critical Control Point inspection system as the standard for exporting to the United States. A three week basic course is offered in Washington (English required) and in Puerto Rico (Spanish required). A two-week advanced course is offered in Texas. A total of 90 officials from at least 30 countries participate in these seminars. Outreach to China on U.S. regulatory requirements - The CPSC will continue to conduct multiple outreach and training events for Chinese government officials on U.S. regulatory requirements. A third biennial U.S.–Sino Product Safety Summit will be held in 2009 with AQSIQ and will build on the previous two with the goal of institutionalizing a culture of product safety among Chinese consumer product manufacturers and exporters. Cosponsoring Food Safety Systems Seminar - China, Australia, Peru and the United States are co-sponsoring a Food Safety Systems Seminar in Cuzco, Peru in conjunction with APEC SOM III meetings. This event will also provide training on international food safety standards and the role of risk and scientific analyses in regulation. Joint safety conference - The CPSC and the EU will hold a joint safety conference in China in September 2008. Meetings with Vietnamese officials - The CPSC will also hold meetings with Vietnamese officials in September 2008.
Recommendation #6: Harmonize Federal Government Procedures and Requirements for Processing Import Shipments.Accomplishments Collaboration with foreign counterparts - HHS discussed import safety with counterparts from China, Canada, Australia, New Zealand, Mexico, India, Vietnam, and several other countries. Established high level-working group - CBP established a high level-working group of departments and agencies to identify and address the combined efforts of Common Mission for imported product safety. This interagency working group has been created to address with uniformity import safety protocols and areas of concern. The working group also improves the communication within participating Federal Government agencies at a headquarters level and at the ports of entry concerning the prevention of unsafe products while facilitating legitimate trade. The working group has met on multiple occasions to understand and address each agency’s obstacles, legal authorities and operational resources. Co-location of border officials - Currently CBP’s National Targeting Center (NTC) accommodates FDA and USDA officials. The co-location of border officials from multiple agencies is an important piece of adopting uniform procedures. Border officials work collectively to assess risk and target commodities for review and examination Establish Import Surveillance Division - CPSC established an Import Surveillance Division within the Office of Compliance and Field Operations and began placing the first full-time presence of CPSC personnel at key U.S. ports of entry.
Looking Ahead Develop rapid response plan - A collaborative effort in the development of a rapid response plan for import safety incidents will begin in the summer of 2008. Test rapid response plan - Upon completion of the rapid response plan, a testing phase will proceed to identify and address any possible flaws. Classes for audit officials - By autumn 2008, classes will be scheduled for the first group of CBP audit officials to be trained under CPSC regulations. Proposed rule on products refused entry - HHS/FDA plans to issue a proposed marking rule meant to ensure products refused entry are marked “U.S. Refused Entry,” which implements section 308 of the Public Health Security and Bioterrorism Preparedness Act of 2002.
Recommendation #7: Complete a Single-Window Interface for the Intra-agency, Interagency and Private Sector Exchange of Import Data.Accomplishments Determine agency import information needs - CBP met multiple times with FWS, FSIS, OFAC, NMFS, APHIS, ATF and EPA in February, March and April 2008 to determine the information required by the particular agency; outlining the capabilities and limitations of their automated systems for the first phase of an import transaction. ITDS - A total of 44 government agencies participate in the International Trade Data System (ITDS). Increased ACE users - The number of registered agency portal users within CBP’s Automated Commercial Environment (ACE) has increased by more than 25 percent allowing additional participating government agencies the ability to retrieve an increased amount of import information. Use ACE to target shipments - CPSC is using CBP’s ACE portal to target shipments and to support enforcement actions at ports of entry. Implemented tracking system of illegal shipments - In April 2008, FSIS implemented the Import Alert Tracking System (IATS), an automated data system that tracks entries of ineligible, illegal, or smuggled shipments of meat, poultry or egg products found in commerce. The IATS automatically notifies FSIS program areas and triggers the convening of the Emergency Management Council in the event of a non-routine incident. Notification to other government agencies is tracked within the system as well. Initiate electronic transfer of certificate data - As an interim measure until the ACE interface is achieved, FSIS initiated electronic transfer of certificate data directly from the New Zealand Food Safety Authority into the AIIS on April 28, 2008 in a User Acceptance Test phase. Submit ACE system requirements - DOT submitted information for definition and business and system requirements, completed a 3-day requirements working session with Customs and Border Protection (CBP), and will continue negotiations with CBP representatives on DOT business and system requirements. Publish system of record notice for international freight data system - The System of Record Notice for the International Freight Data System (IFDS) has been published by DOT in the Federal Register in May 2008, and the Privacy Impact Assessment for the IFDS is nearly final.
Looking Ahead ACE cargo release requirements - CBP’s ACE will collect, refine and integrate the import safety agencies cargo release requirements, including the facilitation of electronic license, permit and certificate data within ACE. Standard Establishment Data Service module - CBP will share with other agencies the possible methodologies to identify foreign based parties to an import transaction. Department and Agency Coding Systems for Imported Products - CBP will lead a cross agency effort to identify and assess industry standard coding systems. Interagency Data Exchange Capabilities - Upon completion of the evaluation of all participating departments and agencies’ data systems, determinations will be made on what information will and can be exchanged. CBP’s ACE Truck Manifest - By October 2008, CBP and the Federal Motor Carrier Safety Administration (FMCSA) will work together to finalize the development, implementation and training necessary to integrate driver safety requirements of FMCSA into the ACE Truck Manifest capabilities. CBP’s ACE Rail/Sea - By December 2008, CBP will provide the necessary access to the full range import data; deploy new ACE Sea and Rail manifest capabilities for those import safety agencies that have legal authority to place holds on cargo.
Recommendation #8: Create an Interactive Import-Safety Information Network.Accomplishments Application of CBP’s compliance program - On April 3, 2008, multiple divisions of CBP worked with representatives of the trade community, trade committees and sub-committees on application of CBP’s compliance program. Data sharing between agenices - Representatives from numerous agencies have met regarding regulatory interaction that takes place during the clearance process and the permissible amount of data that can be shared between agencies.
Looking Ahead Import safety partnership program - CBP and CPSC will continue to work together in the development of the import safety partnership program by implementing an import safety component within CBP’s Importer Self Assessment Program. Upon the completion of the collection of all the data requirements from the participating agencies, CBP can analyze what information is beneficial and begin discussions on the needs of the other agencies. Improve bilateral cooperation between EU and U.S. customs authorities - In addition, the U.S.-EU import safety information sharing report delivered to the TEC on May 13, 2008 contains several conclusions and recommendations regarding increased cooperation between U.S. and EU Customs authorities. We are exploring options on how to further improve bilateral cooperation between EU and U.S. customs authorities in this area.
Recommendation #9: Expand Laboratory Capacity and Develop Rapid Test Methods for Swift Identification of Hazards.Accomplishments Utilize new methods in testing food safety - HHS/FDA is utilizing new methods in testing food safety and hazard identification. Develop new detection methods for food contamination - HHS/FDA developed a rapid detection method using flow cytometry to identify E. Coli and Salmonella in food. This system is being used in poultry processing facilities to detect and prevent bacterial contamination during food processing. Develop new tests for biological agents - HHS/FDA developed a cell-based cytotoxicity assay to assess the biological activity of the bioterrorism agents, ricin and abrin, in infant formulas, fruit juices and yogurt. This assay can be used to assess other chemicals that may be used by terrorists to contaminate the food supply. Utilize new methods in testing food safety - HHS/FDA is using genetic analysis to identify hundreds of Salmonella enterica strains from seafood imports. The analysis provides information that can be used to trace outbreaks of Salmonella enterica and implement surveillance programs to ensure the safety of imported seafood. Conduct training - USDA/FSIS has conducted three Civil Support Team training classes with Department of Defense (DoD), one in each quarter of FY 2008. Deploy teams to possible incidents - Civil Support Teams are deployed within their state to provide first responder food testing capability to any location where intelligence may dictate a possible incident may occur (i.e. sea port, air port) Utilize technology to screen for lead - CPSC has deployed X-ray fluorescence technology to more efficiently screen for lead and other heavy metals in consumer products at the ports. Improve E. coli detection - USDA/FSIS has incorporated a new enrichment media which will improve E. coli O157:H7 detection.
Looking Ahead Hire new FDA employees - HHS/FDA will hire and train 130 new employees to conduct work in the Foods Field program, including food field exams, inspections, and sample collections. This increase will aid in the execution of 20,000 additional food import field exams above the FY 2009 performance goal under the Government Performance and Results Act. Finalize training module - FSIS will finalize the training module with the DoD Training and Doctrine Command evaluation team in July 2008. Upon approval by DoD, the training module will then be deployed to 3-4 FERN Training sites for the training of Civil Support Teams in their respective regions. Increase data submitted to eLEXNET - HHS/FDA plans to work with participating laboratories to increase the quantity and quality of data submitted to eLEXNET, by converting 5-10 manual data submission laboratories to automated data exchange. Develop an integrated North American Laboratory Information Sharing System - HHS/FDA plans to develop an integrated North American Laboratory Information Sharing System for general food safety activities and for emergency response/preparedness. Cooperative Agreement Program renewal awards - Renewal applications for the Cooperative Agreement Program will be reviewed with awards granted in September 2008. Additional Cooperative Agreement labs - Four additional Cooperative Agreement labs will be recruited for FY 09 in addition to the 21 current participants. Upgrade laboratory facilities - The CPSC is planning to upgrade its laboratory facilities to improve efficiency and capacity to test products and conduct research in support of the development of mandatory and consensus standards. Over $10 million has thus far been set aside by the CPSC for this critical project. Occupancy at the CPSC’s new lab is expected to begin in 2009. CPSC utilizing CBP laboratories - CPSC is utilizing CBP laboratories to test products and is also training CBP personnel on CPSC consumer product safety issues. Additional Cooperative Agreement labs - FSIS is reviewing renewal applications for the analytical laboratory Cooperative Agreement Program (CAP) in May, with awards granted in September 2008. Four additional Cooperative Agreement labs will be recruited for FY 2009 in addition to the 21 current participants. Expand list of threat agents - FSIS will complete an expanded list of threat agent validated methods in more matrices in September 2008. Improve screening for E.coli - USDA is developing genetic probes that will enable screening product samples for a broader range of E. coli pathogens, rather than the current strain (E. Coli O157:H7).
Recommendation #10: Strengthen Protection of Intellectual Property Rights (IPR) to Enhance Consumer Safety.Accomplishments Encourage trademark holders to register with CBP - Commerce and other federal agencies began consulting with U.S. industries whose goods may have import safety implications if counterfeited and have initiated outreach efforts to encourage trademark holders to register with CBP to increase effectiveness of enforcement efforts. Train border agents - The Security and Prosperity Partnership Health Working group outlined steps to engage border agents trilaterally in training to identify and respond to fake goods. Coordinate IPR efforts - Government agencies are coordinating their participation with Strategy Targeting Organized Piracy and others involved in import safety to identify and assess IPR resources relevant to import safety issues, including information sharing resources and unsafe counterfeit goods response systems. Increase targeting of counterfeit goods - CBP has increased its targeting of counterfeit goods with a safety risk. As part of these efforts, CBP has carried out special operations focusing on imports of counterfeit integrated circuits and computer networking hardware. Identify and assess IPR resources relevant to import safety - Government agencies are coordinating their participation with Strategy Targeting Organized Piracy and others involved in import safety to identify and assess IPR resources relevant to import safety issues, including information sharing resources and unsafe counterfeit goods response systems.
Looking Ahead Focus on the link between IPR resources and enforcement - Counterfeit goods are often at the heart of import safety problems. The efforts taken to date and those anticipated in the near future will improve import safety through greater focus on the link between IPR resources and enhanced enforcement efforts aimed at removing unsafe counterfeit goods. Develop survey on IPR registration and enforcement - Federal agencies, working with industry partners, will complete the development of voluntary private sector survey on IPR registration and enforcement resources and best practices for dissemination to key private sector stakeholders and the public. Hold roundtable on IPR - Following completion of a private sector survey, the group will hold a one-day roundtable to discuss the results and recommendations of the survey.
Recommendation #11: Maximize the Effectiveness of Product Recalls.Accomplishments Enhance outreach to private sector - Over the last two years, NHTSA has uncovered significant problems related to foreign-made lighting equipment, motorcycle helmets, automotive fuses, and tires leading to many recalls. NHTSA enhanced its outreach activities to explain to companies how to avoid such problems. Increase cooperation with China on motor vehicle safety - On September 12, 2007, NHTSA signed a Memorandum of Cooperation with Chinese government officials aimed at increasing cooperation in the areas of motor vehicle regulation and safety. NHTSA staff continues to make detailed presentations on the agency’s standards and enforcement process and collect information that will be useful in designing strategies to help deter and detect the shipment of noncompliant or defective imports. Implement product recall notification system with China - CPSC implemented a product recall notification program with Chinese Government officials. Through the program, the CPSC sends letters to the Chinese government and the Chinese manufacturer, in both English and Chinese, briefly explaining the recall and enclosing a copy of the press release announcing the recall.
Looking Ahead Recommendation #12: Maximize Federal-State Collaboration.Accomplishments Collaborate with state and local officials on product safety - CPSC, through its State Partners program, works in cooperation with a group of state and local officials to deliver CPSC services to consumers, including recall checks, inspections, and in-depth injury investigations, with an added emphasis on import safety. Collaborate with state commissioners of agriculture and health - FDA held a conference call with the State Commissioners of Agriculture and Health to discuss collaboration between the states and the Agency regarding food safety. Share best practices with state counterparts - FSIS, working closely with other federal agencies, held an all-day public meeting on May 15, 2008, in St. Louis, Missouri enabling local, state, and federal health partners as well as consumer groups and industry an opportunity to share their best practices and challenges to effective coordination during multi-jurisdictional food borne outbreaks.
Looking Ahead Conduct joint enforcement exercise - EPA and CPSC are working to conduct a joint enforcement exercise with CBP and pertinent states, under which illegal all-terrain vehicles are intercepted and enforcement action is taken. Work under this project is expected in the summer of 2008. Meet with states on Food Protection Plan - HHS/FDA will hold a 50-state meeting to further discuss the Food Protection Plan and collaboration between the states and the Agency. The meeting will be held August 12-14, 2008 in St. Louis, Missouri. Establish Federal State Rapid Response Teams - HHS/FDA will issue a Request for Applications for funding to establish Federal State Rapid Response Teams to improve incident response. Host training sessions - CPSC will host training sessions to include import safety issues for state and local officials for its State Partners program in 2008 and 2009.
Recommendation #13: Expedite Consumer Notification of Product Recalls.Accomplishments Strengthen North American recall capacity - North American governments, as part of the SPP took steps to develop North American recall capacity. Hold focus groups on improving recalls - In December 2007, the CPSC held focus groups with consumers on two product recalls and is studying the results to enhance recall effectiveness. Expand email notification of recalls - Consumers can, through email subscription on the FSIS website, receive FSIS recall releases directly. Currently, over 24,500 subscribers receive all news releases and over 26,400 subscribers receive updates on recalls. Expand email notification of recalls - The CPSC has also expanded its “Drive to 1 Million” campaign with a goal of encouraging one million consumers to sign up on the CPSC website for email recall alerts. November 2007 saw the highest number of new subscribers to date, and from November 1, 2007, to May 30, 2008, the number of new subscriptions for email recall alerts has increased 30%
Looking Ahead Pilot on consumer generated media during recalls - HHS/FDA will explore a pilot to assess the use of consumer generated media (e.g. chat rooms) during a recall. This would enable HHS/FDA to use multiple and targeted channels to quickly alert consumers of a threat to food safety. Review emerging recall technologies - CPSC is reviewing new emerging recall technologies. Make public recall consignee names. - FSIS is amending the Federal meat and poultry products inspection regulations to provide that the Agency will make available to the public the names and locations of the retail consignees of meat and poultry products that have been recalled by a federally-inspected meat or poultry establishment, if the recalled product has been distributed to the retail level.
Recommendation #14: Expand the Use of Electronic Track-and-Trace Technologies.Accomplishments Seek public comment on technologies - FDA published two Federal Register (FR) notices pursuant to section 913 of the FDA Amendments Act of 2007 to seek public comment on standards for pharmaceutical serialization, track and trace, and authentication, as well as to seek public comment on technologies used for track and trace and authentication of pharmaceuticals. Track-and-trace technologies can be used as anti-counterfeiting and anti-diversion tools by tracking a product throughout the supply chain. Investigate the use of electronic communication technologies - US Department of Transportation Pipeline and Hazardous Materials Safety Administration (PHMSA) is currently working with international regulatory bodies (United Nations and International Civil Aviation Organization) to investigate the use of electronic communication technologies in lieu of the presently required hazardous materials shipping paper. Investigate the use of electronic communication technologies - PHMSA is working with international hazardous materials carrier groups (Vessel Owners Hazardous Materials Association and International Air Transport Association) to promote the use of electronic communication technologies in international shipments. Ensure the use of electronic shipping papers - PHMSA is also working with sister agencies (NHTSA, FHWA, FMCSA, USCG, FAA and FRA) as well as emergency response groups (International Association of Fire Chiefs, International Association of Fire Fighters, etc) to ensure that the use of electronic shipping papers meets or exceeds the safety requirements inherent in the current regulatory language.
Looking Ahead Establish electronic pedigree on designated drugs - HHS/FDA and the State Food and Drug Administration of the People’s Republic of China (SFDA) are working toward the development of a work plan that will establish an electronic pedigree that may include information on Designated Drugs and their manufacturers on product information (drug name, manufacturer, product registration or identification number); item information (unique product serial number, dosage form, strength, container size, lot number, expiration date); information about each party to the transaction (including company name, street address, license number, contact person, and telephone number); and transaction information (date product was shipped from seller, date received by purchaser).
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