Search results for: fsma

  • Are cotton farmers and ginners subject to FDA’s Food Safety Modernization Act (FSMA)?  If you are a cotton ginner that is not a farm the answer is currently yes. FDA is currently exploring the extent to which cotton ginners should be covered by FSMA. Cotton farmers and ginners, of course, produce the fabrics that we use every day, but they also produce food. After being separated from fibers in a process called ginning, cotton seeds and cotton plant parts are frequently used to feed livestock. Cotton seeds may also be further processed into cottonseed oil and cottonseed meal for animal food.  Because products derived from ginning enter the American food supply, the cotton industry has raised concerns about the impact of the new FSMA requirements on cotton ginners.
  • As background, cotton ginning has traditionally fallen under the general food adulteration provisions of the Federal Food, Drug, and Cosmetic Act.  With the implementation of FSMA, certain operations are now also subject to the FSMA-mandated preventive controls requirements, which applies to manufacturing facilities rather than farms. Most cotton ginning is done by farms, whose ginning operations do not fall under the new requirements.  But cotton gins that are not part of a farm are considered manufacturers subject to the preventive controls requirements, which include a hazard analysis and the implementation of controls to minimize hazards.
  • In August 2016, FDA extended the compliance date for cotton ginners subject to the Preventive Controls for Animal Food rule to allow for additional time to consider how best FSMA should be tailored to cotton ginners (81 FR 57784). Under the extension, regular businesses have until January 28, 2019 to comply, small business until January 27, 2020 and very small business until January 26, 2021.  In the meantime, to better understand industry’s concerns, FDA officials recently traveled to northern Alabama to visit a cotton farm, ginning operation and a cotton warehouse.  In a recent FDA blog post, Dr. Stephen Ostroff, FDA’s Deputy Commissioner for Foods and Veterinary Medicine, indicated that the Agency wishes to further engage stakeholders “in pursuit of a solution that works for industry while protecting public health.”
  • As previously covered on this blog, on April 6, 2016, FDA published a final rule to implement sanitary food transportation requirements under the FDA Food Safety Modernization Act (FSMA).  Click here for a complete copy of the final rule.  Click here for an FDA fact sheet summarizing the final rule, and click here for our summary of the rule and its implications for entities in the food industry.  In short, the final rule establishes sanitary transportation practices for covered entities addressing: (1) vehicles and transportation equipment; (2) transportation operations; (3) training; (4) records; and (5) waivers. The compliance date for most companies was April 2017.  Small businesses have until April 2018 to comply.
  • On November 21, 2017, FDA announced the availability of a Small Entity Compliance Guide (SECG) to help small businesses understand the requirements of the Final Rule on the Sanitary Transportation of Human and Animal Food (Sanitary Transportation Rule). Small businesses have until April 6, 2018, to comply with the rule.
  • The SECG provides descriptions of the rule requirements in a question and answer format that includes information on topics such as training and record keeping. Comments may be submitted to FDA at any time. Instructions on how to submit comments are available in the Federal Register Notice available here (82 FR 55503).

The Daily Intake will return on Monday, November 27.  We extend our best wishes to those of you celebrating the Thanksgiving holiday.

  • The U.S. Food and Drug Administration (FDA) introduced a new web page that consolidates the compliance dates for the Agency’s Food Safety Modernization Act (FSMA) rules. The rules that include compliance dates, in the order they became final, are:
    • Preventive Controls for Human Food
    • Preventive Controls for Animal Food
    • Produce Safety
    • Foreign Supplier Verification
    • Sanitary Transportation
    • Intentional Adulteration
  • These rules have staggered compliance dates, in part, based on the size of a business. FDA also has provided a graphic timeline that shows these staggered compliance dates by month and year.
  • There are no compliance dates for the Accredited Third-Party Certification rule since it is a voluntary program. However, as previously reported on this blog, FDA launched a website earlier this year where an organization can apply to be recognized as a Third-Party accreditation body.
  • FDA also announced that the web pages for the Preventive Control for Human Food and Preventive Controls for Animal Food have been updated as of Oct. 19 and Oct. 20, respectively.
  • Keller and Heckman attorneys regularly advise clients on compliance with FSMA rules. Please feel free to contact us at fooddrug@khlaw.com with any questions.
  • As previously covered on this blog, the Final Rule for Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals, 80 Fed. Reg. 56170 (Sept. 17, 2015) under the Food Safety Modernization Act (FSMA) became effective on November 16, 2015.  Covered large and small businesses are now required to be in compliance with the animal food CGMP requirements. Very small businesses must comply by September 17, 2018.  As of September 18, 2017, large animal food producers were also required to comply with the preventive controls provisions mandated by FSMA.
  • Today, the FDA released two guidance documents intended for facilities that may be subject to the Preventive Controls for Animal Food rule or the Preventive Controls for Human Food rule.
    • The first guidance document, entitled “Guidance for Industry #235: Current Good Manufacturing Practice Requirements for Food for Animals,” will assist animal food facilities that are subject to the Current Good Manufacturing Practice (CGMP) requirements for animal food at 21 CFR Part 507 Subpart B.  The guidance document further elaborates on the following:  (1) applicability of the animal food CGMPs especially with regard to facilities that handle human and animal food, (2) training and qualification requirements, (3) recordkeeping requirements; and (4) further discussion of the specific animal food CGMPs. Appendix B of the guidance document is a Self-Assessment Tool,  that facilities may use to evaluate their compliance with the animal food CGMP requirements.
    • The second guidance document, entitled “Application of the ‘Solely Engaged’ Exemptions in Parts 117 and 507,” addresses the applicability of the “solely engaged” exemptions for the Preventive Controls for Human Food and Preventive Controls for Animal Food rules. In particular, it explains when facilities are exempt from CGMP or preventive controls requirements because they are “solely engaged” in certain activities. The document also explains the circumstances under which the “solely engaged” exemptions do not apply (i.e., when a facility is also conducting certain other activities).  The “Solely engaged” draft guidance is open for a 180-day public comment period.
  • FDA has indicated that they intend to issue separate guidance to address hazard analysis and preventive controls for animal food in the future.
  • FDA’s Produce Safety Rule, implemented under the Food Safety Modernization Act (FSMA), establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables grown for human consumption.  Our detailed summary of the rule is available here.
  • On September 5, 2017, FDA announced the availability of a Small Entity Compliance Guide (SECG) to help small businesses comply with the Produce Safety Rule mandated by FSMA. In particular, the SECG is designed to help farmers determine whether they are eligible for a qualified exemption, which would modify the requirements they are subject to under the Produce Safety Rule.
  • The main compliance dates for small businesses and very small businesses under the Produce Safety Rule are January 28, 2019, and January 27, 2020, respectively, but certain agricultural water requirements have extended compliance dates (see previous blog coverage here). Sprout operations also have different compliance dates, and sprout operations that are small businesses and very small businesses have compliance dates of January 26, 2018, and January 28, 2019, respectively. Businesses that intend to claim a qualified exemption by their primary compliance date were required to begin keeping documentation supporting their eligibility for a qualified exemption on January 26, 2016.
  • On May 27, 2016, FDA published its final rule to implement the intentional adulteration (or “food defense”) provisions of the FDA Food Safety Modernization Act (FSMA).  Click here for a copy of the final rule.  Click here for an FDA fact sheet summarizing the final rule.
  • In short, the final rule establishes various food defense measures that registered facilities are required to implement to protect against the intentional adulteration of food.  As a general matter, facilities must prepare and implement a written food defense plan that identifies significant vulnerabilities and actionable process steps, mitigation strategies, and procedures for food defense monitoring, corrective actions, and verification.  Facilities also have new training and recordkeeping requirements under the final rule.  Several types of facilities and activities are exempt from compliance.  Specifically, the new requirements do not apply to:  (i) very small businesses; (ii) the holding of food, except the holding of food in liquid storage tanks; (iii) the packing, re-packing, labeling, or re-labeling of food where the container that directly contacts the food remains intact; (iv) activities that fall within the definition of “farm”; (v) animal food; (vi) alcoholic beverages under certain conditions; and (vii) certain on-farm food/activity combinations performed by small or very small businesses.
  • On August 24, 2017, the FDA announced the availability of a Compliance Guide to help small businesses comply with the Final Rule on Mitigation Strategies to Protect Food Against Intentional Adulteration (or Intentional Adulteration Rule), mandated by FSMA.
  • The Compliance Guide was prepared in accordance with the Small Business Regulatory Enforcement and Fairness Act. The Guide provides nonbinding recommendations on topics including, but not limited to:
    • Who must comply with the rule and when;
    • Developing a food defense plan;
    • Records management; and
    • Education, training and qualifications.
  • The compliance date for small businesses under the Intentional Adulteration Rule is July 27, 2020. Keller and Heckman actively advises on FSMA compliance matters and stands ready to assist interested parties in this regard.
  • The Food Safety Modernization Act (FSMA) Final Rule for Preventive Controls for Human Food was published on September 17, 2015 (80 FR 55907), and compliance dates for some businesses began in September 2016.  The final rule implements hazard analysis and risk-based preventive controls (HARPC) for human food production. The new HARPC requirements implemented by the final rule are codified at 21 CFR Part 117, Subpart C. A corresponding Draft Guidance document is available here. The Draft Guidance explains FDA’s current thinking on how to comply with certain HARPC requirements and specifically addresses how food producers should go about developing an appropriate food safety plan.
  • On August 22, 2017, FDA launched the Food Safety Plan Builder (FSPB), a free software application developed by FDA to further assist businesses meet the requirements of the FSMA Final Rule for Preventive Controls for Human Food.  The software is downloadable from FDA’s website and is designed to guide businesses, step-by-step, through the creation of a food safety plan, as required by FSMA. FDA has released videos that provide tutorials on how to use the FSPB software.
  • Use of the software is strictly optional. FDA is not requiring use of this tool to develop a facility’s food safety plan, but use of the software could potentially help companies organize their food safety information and minimize the burden of creating their food safety plan. Manufacturers with questions about how to use the FSPB software may contact FDA at: FoodSafetyPlanBuilder@fda.hhs.gov.

FDA announces FSMA funds to support states’ continued implementation of the produce safety rule.

  • The Food Safety Modernization Act (FSMA) was designed to update and strengthen FDA’s risk-based approach to the oversight of food safety.  The produce safety rule – which establishes science-based minimum standards for the safe growing, harvesting, packing and holding of fruits and vegetables grown for human consumption – is a critical part of FSMA.
  • On July 19, 2017, FDA announced that FDA is awarding $30.9 million in funding to support 43 states in their continued efforts to help implement the produce safety rule. This is the largest allocation of funds to date, made available by the FDA to help state agencies support FSMA produce safety rule implementation and develop state-based produce safety programs.  FDA notes that the funding will ensure that awardees have the resources to formulate a multi-year plan to implement a produce safety system and develop and provide education, outreach and technical assistance.
  • Due to the inherent complexity and breadth of the FSMA requirements, FDA must rely on strong partnerships with state agencies to ensure comprehensive and effective implementation.
  • As previously covered on this blog, the general compliance date for the foreign supplier verification program (FSVP), under the Food Safety Modernization Act (FSMA), is May 30, 2017. The U.S. Food and Drug Administration recently issued updated fact sheets, and new guidance on how to identify the importer under the FSVP Rule.
  • The May 30th deadline generally applies to importers whose foreign supplier falls into one of the following categories:
  • Although not reflected in the newly-issued guidance, FDA announced in August 2016 that with respect to food contact substances (FCSs), importers have an additional two years to meet the FSVP requirements; as a result, the earliest FSVP compliance date for FCSs is May 28, 2019.
  • In the guidance, FDA has clarified that it will be permissible to use the code “UNK” (to represent “unknown”) in the unique facility identifier (UFI) field if the FSVP importer is temporarily unable to obtain a Dun & Bradstreet (D&B) Data Universal Numbering System (DUNS) number.
  • We will continue to monitor and report on FDA’s activities to implement the FSVP rule and other FSMA related activities. Please feel free to contact us at fooddrug@khlaw.com with any questions.