The Food Safety Modernization Act

1,923 views

Published on

The recently enacted Food Safety Modernization Act is the greatest expansion of FDA’s food regulatory authority since the enactment in 1938 of the Federal Food, Drug, and Cosmetic Act. This presentation discuses the scope, impact and implementation of the Act. Presented by FDAImports.com Founder and CEO, Benjamin England.

For more on the Food Safety Modernization Act and how it affects companies, manufacturers and importers please visit:

http://www.fdaimports.com/FSMA

Published in: Business
0 Comments
1 Like
Statistics
Notes
  • Be the first to comment

No Downloads
Views
Total views
1,923
On SlideShare
0
From Embeds
0
Number of Embeds
226
Actions
Shares
0
Downloads
0
Comments
0
Likes
1
Embeds 0
No embeds

No notes for slide
  • …Introduction…BLEA & FDAImports.com….
  • Today I am going to be discussing the changes and affects of the FDA Food Safety Modernization Act, which was enacted January 4, 2011. I will not cover every aspect of the Act. Particularly, I will not talk about those requirements in the Act that instruct FDA to perform studies, coordinate with federal agencies, state or foreign governments, or to provide reports to Congress. Instead, I shall discuss those aspects that will affect industry directly, either through new responsibilities for industry or new powers for FDA.  I will begin by discussing aspects that relate to the food industry generally. These requirements will apply to both domestic and foreign food and facilities. Next, I will turn to the requirements that will apply to importers and imported food. Lastly, I will discuss some additional items that do not fit within either category. Afterwards, I will provide some general conclusions about FSMA and take your questions.
  • FSMA, originally known as Senate Bill 510, had a long, round-about way to becoming enacted. But ultimately, President Obama signed FSMA on January 4, 2011. FSMA specifically concerns food. Therefore, it also affects dietary supplements, which is a special classification of food. Yet, FSMA might also affect other industries, such as the pharmaceutical industry, because it uses “foods”, such as sugar, in its drugs. While Congress did not likely intend for FSMA to affect the pharmaceutical industry, FDA may still pressure it to comply with certain aspects of FSMA.  A major defect from a regulatory standpoint of FSMA is its lack of appropriations. FSMA mandates FDA to engage in numerous new regulatory activities, which requires additional staff and resources. Yet, FSMA does not include appropriations. Currently, it remains unknown if FDA will gain these additional funds.  The current Congress has expressed hostility to the additional costs imposed by FMSA. Members of the Republican House majority have questioned if the country can afford FSMA’s cost. Representative Jack Kingston of Georgia (ranking Republican member on the House’s appropriations subcommittee overseeing FDA) stated “No one wants anybody to get sick, and we should always strive to make sure food is safe. But the case for a $1.4 billion expenditure isn't there.” [quoted inLyndsey Layton, Food Safety Overhaul Faces Obstacles, Wash. Post, December 24, 2010.]
  • The HARPC requirement is akin to the HACCP requirement for seafood and juice. Under HARPC, each facility must engage in a series of tasks: conduct hazard analysis, develop and implement preventive controls, and monitor the control’s effectiveness; develop a written plan for controlling the hazards; reanalyze for the potential hazards at least every 3 years; verify the effectiveness of the controls; and maintain records of the verification process.The ultimate purpose of this process is to provide assurances that the food is not adulterated or misbranded by failing to declare a major food allergen.
  • Certain facilities are exempt from HARPC.Those include:(1) Facilities subject to Standards of Produce Safety, (2) Facilities subject to HACCP and low-acid canned food standards, and (3) Facilities subject to dietary supplement cGMPs.  FSMA requires FDA to issue regulations by July 4, 2012, which must also define a “small” and “very small” business. Regardless if FDA implements the regulations, HARPC has an effective date of July 4, 2012, unless the facility classifies as a “small business” or a “very small business”. In the case of a small business, the HARPC requirements must be met 6 months after the effective date of the regulations. For a very small business, the HARPC requirements must be met 18 months after the effective date of the regulations.
  • FSMA thrusts FDA into agriculture, an unknown world to the Agency. FMSA instructs FDA to work with USDA and establish standards for producing and harvesting raw agricultural commodities. FDA is supposed to prioritize its work based upon commodities that have been associated with food borne illnesses.  
  • Standards for Produce Safety do not apply to facilities subject to the HARPC requirements. Therefore, essentially every food facility or farm will be either subject to the Standards for Produce Safety, HARPC or HACCP. This added burden greatly concerned the family-owned farm community and supporters of the farmers markets. With that in mind, FSMA has an exemption for foods directly from a farm to a consumer of the food, or a restaurant or retail food establishment (in the same state or within 275 miles). Unrealistically, FSMA instructs FDA to issue notice of proposed rulemaking by January 4, 2012. Then FDA must finalize the regulations within 1 year after the close of the comment period. Given the burden these standards will place on small farms, a “small business” gets an extra year after the effective date of the regulations to implement them. A “very small business” gets an extra two years after the effective date of the regulations to implement them. FDA will likely struggle to fulfill this mandate to craft Standards for Produce Safety. The Agency lacks any substantive experience with raw agricultural commodities, especially not their production and harvesting. The lack of institutional competency will create years of uncertainty for the industry as the Agency takes its first steps and learns to walk. This process will likely look similar to FDA’s recent attempts to regulate the tobacco industry according to the tobacco legislation.  We must remain mindful though that these standards will not only dramatically alter the farming process for over 1 million farms in the United States. As we will see, these standards will also apply to imported produce.
  • FSMA mandates FDA to inspect both domestic and foreign facilities in increasing numbers. For domestic facilities, FSMA establishes two different inspection requirements based upon the facility’s classification. For a high risk facility, FDA must inspect it by 2016 (within 5 years) and not less than once every 3 years thereafter. On the other hand, for a non-high risk facility, FDA must inspect it by 2018 (within 7 years) and not less than once every 5 years thereafter. I doubt that FDA will effectively inspect all the food facilities in the United States according to FSMA. Currently, FDA only conducts a limited of number of inspections each year of over 150,000 domestic registered food facilities. FDA, Strategic Priorities 2011-2015, Draft, 14 (2010). FDA currently lacks the staff and resources to fulfill this mandate; for example, in 2003 FDA and USDA together only inspected 1,451 facilities. GAO, FDA’s Food Protection Plan Proposes Positive First Steps, but Capacity to Carry Them Out is Critical, GAO-08-435T, 8 (2008). By January 4, 2012, FDA must inspect 600 foreign facilities. This is a monumentally high number of foreign food facility inspections when compared to the number of foreign inspections FDA has conducted in the last several years. For example, FDA inspected only 13 food facilities in China between 2008 and 2010. [Government Accountability Office, Overseas Offices Have Taken Steps to Help Ensure Import Safety, but More Long-Term Planning Is Needed, GAO-10-960, 17 (2010)] Then, FDA must double the number of foreign inspections each year for the next 5 years. Therefore, FDA must inspect at least 19,200 foreign facilities in 2017 (assuming it inspects the minimum number of foreign facilities each year).  A foreign facility cannot refuse a FDA inspection and continue to import food into the United States. FSMA prohibits the importation of food from a facility where theforeign government refuses the inspection, or the owner, operator, or agent refuses the inspection. This mandate will likely go unmet. FSMA did not include appropriations and the current Congress has expressed hostility for funding FSMA. Factors for determining “high risk” are: (1) Actual known risks, (2) Compliance history, (3) Rigor of facility’s HARPC plan, (4) risk of intentional adulteration in imports, (5) non-certified importers, and (6) any other criteria they want.
  • FSMA grants FDA mandatory food recall authority for the first time. FDA must undergo a three step process in order to mandate a recall.  To begin with, FDA must determine there is a reasonable probability that the food is adulterated or misbranded by failing to disclose major food allergens, and the food will cause serious adverse health consequences or death.  
  • Once FDA satisfies its burden, FDA must provide the responsible party an opportunity to cease distribution and recall the food voluntarily. FDA may require an immediate stop of the food’s distribution, if the responsible party refuses to cease distribution or recall the food in the timeframe specified by FDA. If FDA orders to cease distribution, it must provide the responsible party the opportunity for an informal hearing as soon as possible, but not later than 2 days after issuing the order. After the hearing, FDA can either order a recall or vacate its order to cease distribution. Once a recall is final, the FDA must post a press release on its website.If a mandatory recall occurs, the responsible party must pay a fee that covers the cost of all activities associated with it, “including technical assistance, follow-up effectiveness checks, and public notifications.”,DA’s Commissioner cannot delegate this authority to mandatorily recall food.
  • FDA may begin to require a responsible party to submit consumer-oriented information regarding a reportable food. This information may include:(1) a description of the food, (2) affected product’s identification codes, (3) contact information, and (4) any other information deemed necessary.
  • A one-page summary must be published on FDA’s website that can be easily printed by a grocery store for consumer notification. Grocery stores with 15 or more physical locations will have 24 hours from the creation of this page to display the information prominently. The information must be displayed for 14 days. FDA may require this system for reportable foods not later than July 4, 2012 
  • Food facilities, as defined in the Public Health Security and Bioterrorism and Response Act of 2002, must register with FDA and renew their registration biannually. The registration will now require a facility to provide FDA with an email address for the contact person. FDA may suspend a facility’s registration if FDA has reasonable probability that food from the facility will cause serious adverse health consequences or death to humans or animals. A facility with a suspended registration cannot import or introduce food into interstate commerce.  Additionally, FSMA instructs FDA to propose regulations that specify which activities constitute on-farm packing, manufacturing, or processing of food not grown, raised, or consumed on a farm or another farm owned by the same entity. This regulation is necessary to determine which facilities must register as a food facility (farms are exempt from facility registration).
  • FSMA expands FDA’s ability to inspect records by creating two routes for inspecting records. The first route (adulterated food) is already part of the FDCA. Under this route, FDA must have a reasonable belief that the food is (1) adulterated and (2) presents a threat of serious adverse health consequences or death to humans or animal. The second route (use of or exposure to food) has been added by FSMA. Under this route, FDA must have a reasonable probability that the use of or exposure to the food will cause serious adverse health consequences or death to humans or animal. Under either route, FDA can also obtain records for “any other article of food that [FDA] reasonably believes is likely to be affected in a similar manner”. This expands FDA’s record inspection powers. Once FDA concludes a food satisfies one of the two routes, then it can inspect the records of any other foods that FDA reasonably believes is affected in a similar manner. This way of obtaining records for “other foods” does not require FDA to satisfy the requirements of the two routes. FDA only needs a reasonably belief the other food is affected in a similar manner.  FDA has access to any records needed to assist in “determining whether there is a reasonable probability” that the food presents a threat of serious adverse health consequences or death to humans or animals. “[R]easonable probability” is the same as the standard for revoking facility registration and mandating a food recall. Thus, the inspection of records can serve as a stepping stone to these enforcement actions by FDA.
  • Beyond the general record keeping requirements, FSMA instructs FDA to establish additional record keeping requirements for a facility that manufacture, pack, or hold “high risk” foods. FDA must designate high risk foods by January 4, 2012. In turn, FDA must propose record keeping regulations by January 4, 2013.
  • FSMA lowers FDA’s burden in order to administratively detain food. Currently, FDCA § 304(h)(1)(A) permits a detention when there is “credible evidence or information indicating that such article presents a threat of serious adverse health consequences or death to humans or animals.” FSMA changes this section to read that detention can occur when FDA determines there is “reason to believe that such article is adulterated or misbranded.” This new burden becomes effective on July 3, 2011. FSMA instructs FDA to assess the vulnerability of the food system to intentional adulteration. In turn, FDA is required to promulgate regulations to protect against intentional adulteration. FSMA specifically instructs FDA to consider food with clear vulnerabilities, such as food with a short shelf-life, and in bulk form, prior to being packaged for the final consumer. The Act requires FDA to issues these regulations by July 4, 2012. FSMA instructs FDA to promulgate regulations for those engaged in transporting food to use sanitary practices. FDCA already contained this mandate prior to FSMA. FSMA requires FDA to issues the regulations by July 4, 2012.
  • FSMA places the burden on importers to verify the safety of the food offered for import through the Foreign Supplier Verification Program. Every importer must establish a plan where it verifies that the foreign supplier complies HARPC or Standards for Produce Safety and that the food is not adulterated and misbranded by failing to disclose major food allergens. Additionally, the importer must maintain records for 2 years that substantiates its compliance with this requirement.  Noncompliance is a prohibited act and an importer cannot import a food if the importer fails this requirement.
  • An importer of certain foods is exempt from this requirement. The importer is exempt if the food comes from a facility required to comply with and is in compliance with seafood HACCP, juice HACCP, or low-acid food packaged standards. This is not surprising because HACCP already requires the importer to verify the foreign manufacturer complies with the HACCP requirement.  While FDA must promulgate regulations by January 4, 2012, the requirement goes into effect on January 4, 2013 regardless if FDA establishes regulations.  This requirement will cause the new HARPC and Standards for Produce Safety to spread worldwide, because the importer has a real interest in ensuring that a food comes from a compliant supplier.
  • FSMA instructs FDA to create the Qualified Importer Program, which is a voluntary program that offers its members an expedited importation process. An importer becomes eligible when FDA determines that the food offered for import is safe and The foreign facility obtains certification by third-party auditors, which verifies the facility complies with the relevant regulations.
  • Once admitted to the program, FDA reviews an importer’s eligibility at least once every three years.  FSMA instructs FDA to institute the program by January 4, 2012, but the administrative process will likely delay the implementation of the program. The participants must pay a fee to participate in this program. The program will offer a large importer an effective means to shorten the delays inherent with importing foods. The program will particularly assist an importer of perishables foods, because importation will take less time.
  • Under FSMA, FDA may require a certificate for importing certain foods based on the health risks associated with the food, or the food’s place of origin. The importer must obtain the certificate from either an agency or representative of the government of origin, or an accredited third-party auditor. This grant of power does not instruct FDA to establish regulations by any date.  FSMA requires that the Prior Notice for an imported food state whether any country has refused entry to the specific food being imported. This requirement becomes effective July 3, 2011.
  • FSMA instructs FDA to notify Customs each time FDA refuses to admit a food into the United States. The notification will allow Customs to prevent the same food from being admitted via another port of entry. This requirement remains in effect until FDA promulgates the final regulation under FDCA 801(n). The proposed regulation (proposed in September 2008) would require food refused entry into the United States to bear a label affixed to the shipping container stating “UNITED STATES: REFUSED”. FSMA instructs FDA to coordinate with the Department of Homeland Security to develop and implement a strategy to better identify smuggled food and to prevent its entry into the United States. FDA shall provide a press release describing a smuggled food when:FDA reasonably believes would cause serious adverse health consequences or death, and FDA reasonably believes that the food has entered domestic commerce and is likely to be consumed.
  • FSMA institutes fees for four items: food recalls, reinspectionsof a facility, reinspectionsof an import, and Qualified Importer Program. First, the party responsible for a food recall must pay a fee covering the costs for all activities associated with the recall, “including technical assistance, follow-up effectiveness checks, and public notifications.” Second, an importer or facility must cover all administrative costs associated with a reinspection of a facility. Third, an importer likewise must cover all costs including administrative costs associated with reinspection. In both instances administrative costs include “arranging, conducting, and evaluating the results of reinspection; and assessing and collecting reinspection fees…”. Fourth, importers participating in the voluntary Qualified Importer Program must pay a yearly fee, which will cover the administrative costs of the program.
  • A company in the food industry is prohibited from taking punitive actions against an employee who provides to the company or enforcement authorities information about a violation, or refuse to participate in actions related to violations of the FDCA.
  • After reviewing a NDI notification, FDA must inform DEA if FDA determines that the notification lacks adequate information to establish the NDI is reasonably expected to be safe because it may be or may contain an anabolic steroid or analogue of an anabolic steroid (as defined in the Controlled Substances Act). FDA must provide DEA with at least the name of the dietary supplement, the person marketing it or the person who submitted the notification, and any contact information. FDA is instructed to publish a guidance clarifying when a dietary ingredient is a new dietary ingredient, thereby clarifying when the manufacturer or distributor of the ingredient or supplement must provide notification to the Agency.
  • After reviewing a NDI notification, FDA must inform DEA if FDA determines that the notification lacks adequate information to establish the NDI is reasonably expected to be safe because it may be or may contain an anabolic steroid or analogue of an anabolic steroid (as defined in the Controlled Substances Act). FDA must provide DEA with at least the name of the dietary supplement, the person marketing it or the person who submitted the notification, and any contact information. FDA is instructed to publish a guidance clarifying when a dietary ingredient is a new dietary ingredient, thereby clarifying when the manufacturer or distributor of the ingredient or supplement must provide notification to the Agency.
  • By and large, FSMA will not have an immediate effect on the food industry, because many of its requirements become effective in 1 to 2 years, or require FDA to establish regulations before becoming effective. Yet, in time, the industry will have to develop greater safety procedures to comply with HARPC requirement and other regulations established by FDA. Also, industry will have to develop efficient systems for maintaining all the records required by FSMA and the regulations implemented according to it.  The FDAs’ Strategic Priorities stated that the Agency would place its emphasis on preventing food borne illness. FSMA provides the means for FDA to implement its goal with the HARPC, Standards for Produce Safety, and instructions to implement safety regulations. Through these requirements, FDA can regulate the food industry in such a way to better prevent illness.  Industry has a greater responsibility for ensuring food safety. First, the industry must follow these new standards established in HARPC, Standards for Produce Safety, and other regulations. Second, industry importers must assist in regulating the international food industry, because importers must verify the foreign industry complies with the safety requirement. This further institutes self-regulation. Under this new system, industry bears the burden for ensuring food safety and FDA takes the role of verifying that the industry is regulating itself.
  • The Food Safety Modernization Act

    1. 1. FDAImports.com,
    2. 2. 
    3. 3.  ◦ ◦
    4. 4. 
    5. 5.  ◦ ◦ ◦ ◦ ◦
    6. 6.  ◦ ◦ ◦
    7. 7. 
    8. 8.  ◦ ◦   ◦ ◦
    9. 9.  ◦  ◦  ◦ ◦
    10. 10.  ◦ ◦
    11. 11. 
    12. 12.  ◦ ◦ ◦ ◦
    13. 13.  ◦ ◦
    14. 14.  ◦ ◦
    15. 15.  ◦ ◦ ◦ ◦ ◦
    16. 16.  ◦ ◦
    17. 17.  ◦ ◦ ◦
    18. 18. 
    19. 19.  ◦ ◦
    20. 20.  ◦   
    21. 21. 
    22. 22.  ◦
    23. 23.  ◦   ◦ ◦
    24. 24.  ◦ ◦ ◦
    25. 25. 
    26. 26.
    27. 27.  ◦
    28. 28.  ◦ ◦ ◦
    29. 29. v v v v v v
    30. 30.  ◦ ◦ ◦
    31. 31. FDAIMPORTS.COM6420 Dobbin Road, Suite E, Columbia, MD 21045410-740-3403 (Phone)443-583-1464 (Fax)info@fdaimports.comww.fdaimports.com© 2011 FDAImports.com

    ×