FDA Extends Comment Deadline on Sanitary Transportation Rule

 

In 1990, Congress enacted the Sanitary Food Transportation Act that directed the Department of Transportation to promulgate regulations for the transportation of food to ensure its safety. DOT issued a proposed rule in 1993, but later determined that it lacked the expertise to implement the law. Congress amended the law in 2005 giving FDA the authority to implement it, but with no deadline for rule making. Section 111 of the Food Safety Modernization Act directed FDA to promulgate final regulations no later than 18 months after enactment of the act. FDA published a proposed rule on February 5, 2014.

In response to requests from stakeholders, FDA extended the May 31, 2014 comment deadline on its proposal to establish sanitary transportation requirements for vehicles and transportation equipment. The new deadline for public comment is July 30, 2014. In a May 8 letter, 22 industry groups sought a 90-day extension and said they needed more time to consider several sections of the proposed rule that could have “unintended consequences.” FDA granted a 60-day extension. The agency has a court-ordered deadline of March 31, 2016 for issuing the final rule.

The proposed rule on sanitary transportation of human and animal foods is one of seven regulations mandated by the Food Safety Modernization Act.

As I mentioned in the February issue, this rule is a key component of the implementation of FSMA’s provisions. The sanitary transportation rule deals with requirements for refrigeration of food, cleaning of vehicles between shipments, and protection of food during transportation. The proposed rule would establish requirements for vehicles and transportation equipment and operations, as well as for training, records and procedures for waivers.

With some exceptions, the rule would apply to shippers, receivers, and carriers who transport food in the United States by motor or rail vehicle, whether or not the food enters interstate commerce. It would also apply to a person outside of the United States, such as an exporter, who ships food to the United States in an international freight container if it will be consumed or distributed in the United States.

Among the exemptions are the transportation of raw agricultural commodities performed by farms. Also exempt are shippers, receivers, or carriers engaged in food transportation operations that have less than $500,000 in total annual sales. Food that is transshipped and not meant for consumption in the U.S. is also exempt, as well as shelf-stable foods, compressed food gases and live food animals.

According to FDA’s estimates the proposed sanitary transportation rule will impact 83,609 businesses and the average cost is estimated at $1,784 per business in the first year, for a total of $149.1 million. The ongoing annual cost to the regulated companies is estimated at over $30 million.

As you will see elsewhere in this issue, I will be participating in a FSMA panel with CFSAN Director Michael Landa and former CFSAN Director Robert Brackett at the IFT annual meeting in New Orleans in a June 23 1:30 p.m. session. And it’s a safe bet that this proposed transportation rule will feature there among other hot topics.

FDA’s Strategy for Implementing Next Phase of FSMA

FDA offers some insights into its strategy for implementing the next phase of the Food Safety Modernization Act (FSMA) in a guidance document posted on the agency’s website May 2. A key element of the agency’s operational strategy will be to rely heavily on the industry to implement preventive measures.

The agency says the industry needs to work in a continuous improvement mode and to manage operations and supply chains “in a manner that provides documented assurances that appropriate preventive measures are being implemented as a matter of routine practice every day.”

I would especially draw your attention to the appendix to the guidance, which details some of the ways the agency plans to implement FSMA’s provisions. FDA will vary its strategy for different types of food facilities. For food and animal feed facilities, for example, the agency says it will significantly expand its inspection and surveillance tools to include a wider range of inspection, sampling, testing, and other data collection activities conducted through its own field force and through collaboration with partner agencies and the food industry.

For these facilities, inspection and surveillance will include:

  • Efficiently screening firms for food safety performance to guide risk-based inspection priority, frequency, depth, and approach;
  • Providing firms incentives for compliance through enhanced presence in and targeted scrutiny of high-risk firms and products and reduced scrutiny of firms with records of demonstrated good performance;
  • Assessing the compliance of individual firms through a range of inspection and sampling techniques used in a strategic, risk-based way to maximize coverage of priority sectors and firms;
  • Making in-depth assessments of individual firms when needed to increase the incentive for compliance and determine the need for compliance or enforcement actions
  • Collecting data to inform understanding and analysis of sector-wide hazards, practices, and preventive control deficiencies; and
  • Collecting data on compliance rates to evaluate program performance and plan future efforts

The agency says its primary compliance tools will be administrative actions rather than court enforcement cases. The administrative actions will include:

  • Voluntary correction of problems at the facility level, achieved immediately during the course of an inspection through communication with firm management by investigators and, as needed, Center technical staff;
  • Voluntary correction achieved at the District level through deficiency letters, issued within days after an inspection with Center back up, to document significant safety-related deficiencies and request correction within a specified period, with immediate inspection follow up to verify correction;
  • Administrative detention of product if needed to provide immediate public health protection or for other appropriate purposes;
  • Voluntary and mandatory recalls to remove potentially hazardous food from the market; and
  • Administrative suspension of registration when other administrative compliance measures have failed or are inadequate to achieve correction of significant deficiencies that put consumers at risk.

FDA’s judicial enforcement tools will include:

  • Seizure actions that are needed to back up administrative detentions;
  • Injunction actions when suspension of registration or other measures are inadequate to prevent future non-compliance; and
  • Criminal prosecution for falsifying records, lying to FDA, knowingly putting consumers at risk, or in other appropriate cases.

A Different Approach for Produce

Implementation of FSMA’s produce safety standards will require a different approach, the agency says. Because of the scale and diversity of the produced sector, “there is no reasonable expectation FDA will have the resources to make routine on-farm inspection a major source of accountability for compliance with produce safety standards.”

So, the agency explains, “FDA’s implementation of produce safety standards will entail a broad, collaborative effort to foster awareness and compliance through guidance, education, and technical assistance, coupled with accountability for compliance from multiple public and private sources, including FDA and partner agencies, USDA audits, marketing agreements, and private audits required by commercial purchasers.”

A Strategy for Imports

For imported foods, the agency will rely primarily on “importers providing documented assurances that their foreign suppliers have taken proper steps to prevent problems.” The agency plans to build its skills and capacity and to focus on auditing foreign supplier verification programs and on holding importers accountable for managing their supply chains.

Resources

According to the Congressional Budget Office, FDA needed $1.4 billion through 2015 to fulfill FSMA requirements. But the agency’s budget for FSMA received only modest increases since the legislation’s enactment.

As examples, the Foreign Supplier Verification Program will require new staff and skills to audit and verify the adequacy of the importer’s verification plan; conduct more foreign inspections; work more on food safety with foreign governments to leverage their efforts; and improve the agency’s data and import systems to facilitate prompt entry of foods that meet U.S. safety standards.

FDA’s strategy relies on partnerships with state departments of agriculture, other state partners, and local, territorial, and tribal authorities to deliver the education, training and technical assistance, as well as compliance oversight, needed to ensure the rules are implemented properly. However, additional resources are required to build the capacity of these partners and provide the needed assistance to growers, especially small and mid-size operators.

This cannot be done unless FDA finds additional resources to build the capacity of its partners and provide the needed assistance to growers, especially small and mid-size operators. The current appropriations are insufficient to take advantage of these opportunities and meet the objectives of FSMA.

FDA Has Higher Expectations for Generic Drug Applications

Generic Drug User Fee Amendment (GDUFA) and You

FDA expects industry to begin submitting higher-quality applications to facilitate expedited reviews and approvals of generic drugs, agency officials explained at the Generic Drug User Fee Amendment (GDUFA) and You Conference in Lake Buena Vista, FL, March 27-28.

The goal of the meeting — which was hosted by the Office of Small Business and Industry Assistance (SBIA) in FDA’s Center for Drug Evaluation and Research (CDER) and presented by FDA’s Office of Generic Drugs (OGD) — was to update participants on FDA’s current activities and future plans for generic drug reviews.

The purpose of GDUFA was to increase the access of U.S. consumers to generic drugs, to ensure that the drugs are manufactured in compliance with FDA regulations, and to improve FDA’s communication with manufacturers of generic drugs and active pharmaceutical ingredients. In short, the goals are to improve access, safety, and transparency. To achieve these goals, FDA will be using a fee-based program to supplement appropriated Congressional funding.

At the Lake Buena Vista meeting, agency officials provided a reviewer’s perspective of an Abbreviated New Drug Application (ANDA), Drug Master Files (DMFs) and the completeness assessment for type II DMFs. The second day featured GDUFA implementation and policy updates; regulatory science; user fees, arrears lists, appeals and waivers; post approval inspections programs and a review of efficiency enhancements.

In GDUFA-related achievements, the agency has made significant progress in reducing the ANDA review backlog. FDA has hired 291 employees, exceeding the hiring target in the Fiscal Year 2013 goal. It has published criteria for Type II DMFs completeness assessments and refuse-to-receive (RTR) standards and it has posted a list of Type II DMFs that have passed the completeness assessment. And it is establishing a public docket to invite comment on ways to improve the quality of the ANDAs, amendments and supplements.

Here are some of my take-home notes from the meeting:

  • The agency will refuse to receive an ANDA if the number of easily remedied deficiencies is equal to or more than 10 or if a response to the fewer than 10 deficiencies is not received within 10 U.S. business days.
  • ANDAs submitted as a single, continuous, non-bookmarked PDF file will be refused.
  • If an applicant is requesting an expedited review, the cover letter must indicate in boldface “Expedited Review Requested” or “eligible for Expedited Review, GDUFA Year 1 or 2 Cohort.”
  • Upon issuing final guidance, FDA will contact a sponsor of an ANDA containing less than 10 easily remedied deficiencies. A response must be provided within 5 U.S. business days. Day 1 of the 5 U.S. business days will commence the day after notification is provided to the applicant. An ANDA will be refused if the number of easily remedied deficiencies is equal to or more than 10 or if a response to the fewer than 10 deficiencies is not received within 5 U.S. business days.
  • Any deficiencies revealed in the Active Pharmaceutical Ingredient (API) review will be communicated to the applicant. If a response is not received within 5 U.S. business days the ANDA will be refused for receipt.
  • Starting in Cohort Year 3 (FY 2015), which begins October 2, 2014, DMFs must be “Available for Reference” at the time of ANDA submission or they will be Refused to Receive (RTR).
  • Starting in Cohort year 3 the DMF fee should be paid a minimum of 6 months ahead of ANDA submissions to ensure the Completeness Assessment (CA) is done and the DMF is available for reference.
  • FDA is encouraging DMF holders to use a 30 minute teleconference for the first cycle of deficiency letters.
  • The agency is encouraging Type II DMF holders to submit the DMFs in eCTD format. This will aid in the review of the applications.

OGD is issuing the ANDA Filing Checklist on a quarterly basis (March, June, September and December). ANDA applicants should use the checklist as a tool to ensure that their application contains all of the appropriate components.

The agency offered other reference tools for applicants to use when preparing their applications, including Final Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Human Pharmaceutical Applications and Related Submission Using the [electronic Common Technical Document (eCTD)] Specifications; FDA eCTD Table of Contents Headings and Hierarchy; Portable Document Format Specifications: Guidance for Industry M4: The CTD – Quality Questions and Answers/Locations Issues, etc.

FDA will be holding a public meeting on May 16, 2014 to provide an overview of the current status of regulatory science initiatives for generic drugs. The agency wants input from industry, academia, professionals and other interested parties as it develops an annual list of regulatory science initiatives specific to generic drugs. FDA will take the information from the public meeting into account in developing its FY 2015 Regulatory Science Plan. The meeting will be held from 9:00 am to 5:00 pm at FDA’s White Oak Campus. Additional information can be found in the February 26, 2014 Federal Register.

In summary, FDA is working on keeping industry updated on the agency’s activities and trying to provide them with as much information as possible. The agency’s expectation is that industry will begin to submit applications that can be reviewed more efficiently.

EAS has available upon request copies of all the slide presentations for the GDUFA and You 2014 meeting.