Havers FP, Moro PL, Hunter P, Hariri S, Bernstein H. Use of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccines: Updated Recommendations of the Advisory Committee on Immunization Practices — United States, 2019. MMWR Morb Mortal Wkly Rep 2020;69:77–83. DOI: http://dx.doi.org/10.15585/mmwr.mm6903a5external icon

FDA

Prepare Yourself Before Power Emergencies

1. Make sure you have appliance thermometers in your refrigerator and freezer.
   • Check to ensure that the freezer temperature is at or below 0° F, and the refrigerator is at or below 40° F.
   • In case of a power outage, the appliance thermometers will indicate the temperatures in the refrigerator and freezer to help you determine if the food is safe.
2. Freeze containers of water for ice to help keep food cold in the freezer, refrigerator, or coolers in case the power goes out. If your normal water supply is contaminated or unavailable, the melting ice will also supply drinking water.
3. Freeze refrigerated items such as leftovers, milk, and fresh meat and poultry that you may not need immediately. This helps keep them at a safe temperature longer.
4. Group food together in the freezer. This helps the food stay cold longer.
5. Have coolers on hand to keep refrigerated food cold if the power will be out for more than 4 hours.
6. Purchase or make ice cubes in advance, and freeze gel packs ahead of time. Store all of these in the freezer for future use in the refrigerator or in coolers.
7. Check out local sources to know where dry ice and block ice can be purchased, in case it should be needed.
8. 1. Store food on shelves that will be safely out of the way of contaminated water in case of flooding.
   2. Make sure to have a supply of bottled water stored where it will be as safe as possible from flooding. If your bottled water has an odor, do not drink or use it. Instead, dispose of it, or if applicable, call your bottled water provider to make arrangements to get a replacement.

   During an emergency, if you use food or beverage containers to hold non-food substances like gasoline, dispose of them after use and do not recycle them.

   Power Outages: During and After

   When the Power Goes Out . . .

   Here are basic tips for keeping food safe:

   1. Keep the refrigerator and freezer doors closed as much as possible to maintain the cold temperature.
      • The refrigerator will keep food cold for about 4 hours if it is unopened.
      • A full freezer will keep the temperature for approximately 48 hours (24 hours if it is half full) if the door remains closed.
   2. Buy dry or block ice to keep the refrigerator as cold as possible if the power is going to be out for a prolonged period of time. Fifty pounds of dry ice should keep an 18 cubic foot, fully stocked freezer cold for two days.
   3. 1. If you plan to eat refrigerated or frozen meat, poultry, fish, or eggs while they are still at safe temperatures, it is important that each item is thoroughly cooked to a safe minimum internal temperature to ensure that any foodborne bacteria that may be present are destroyed. However, if at any point the food was above 40º F for 2 hours or more (or 1 hour if temperatures are above 90 º F) — discard it.

      Once Power is Restored . . .

      Determine the safety of your food:

      1. If an appliance thermometer was kept in the freezer, check the temperature when the power comes back on. If the freezer thermometer reads 40° F or below, the food is safe and may be refrozen.
      2. If a thermometer has not been kept in the freezer, check each package of food to determine its safety. You can’t rely on appearance or odor. If the food still contains ice crystals or is 40° F or below, it is safe to refreeze or cook.
      3. Refrigerated food should be safe as long as the power was out for no more than 4 hours and the refrigerator door was kept shut. Discard any perishable food (such as meat, poultry, fish, eggs, or leftovers) that has been at temperatures above 40° F for 2 hours or more (or 1 hour if temperatures are above 90º F).

      Perishable food such as meat, poultry, seafood, milk, and eggs that are not kept adequately refrigerated or frozen may cause illness if consumed, even when they are thoroughly cooked.

      If Flooding Occurs

   4. Be prepared to safely handle food and water in the event that flooding occurs.

      Keep Water Safe

      Follow these steps to keep your WATER SAFE during and after flood conditions.

      1. Only use water from a safe source for drinking and washing or preparing food.
      2. Use bottled water that has not been exposed to flood waters, if it is available.
      3. If you don’t have bottled water, you should boil or disinfect water to make it safe. (see steps below)
      4. If you have a well that has been flooded, the water should be tested and disinfected after flood waters recede. If you suspect that your well may be contaminated, contact your local or state health department or agricultural extension agent for specific advice.

      How to Boil or Disinfect Water To Make It Safe

      If the water is cloudy, first filter it through clean cloths, or allow it to settle and then draw off the clear water for boiling/ disinfecting. Then, follow one of these two procedures:

   5. Boiling Boiling water will kill most types of disease-causing organisms that may be present.
      1. Boil the water for 1 minute.
      2. Let it cool, and store it in clean containers with covers.

      Disinfecting with Bleach

      Bleach will kill some, but not all, types of disease-causing organisms that may be in the water.

      • Add 1/8 teaspoon (or 8 drops) of unscented household (5.25% concentration) liquid bleach for each gallon of water.
      • Stir it well and let it stand for 30 minutes before you use it.
      • Store disinfected water in clean containers with covers.

      Keep Food Safe

      Follow these steps to keep your FOOD SAFE during and after flood conditions.

      1. Do not eat any food that may have come into contact with flood water.
      2. Discard any food and beverage that is not in a waterproof container if there is any chance that it has come into contact with flood water.
         • Food containers that are waterproof include undamaged, commercially prepared foods in all-metal cans and “retort pouches” (like flexible, shelf-stable juice or seafood pouches).
         • 1. • Food containers that are not waterproof include those with screw-caps, snap lids, pull tops, and crimped caps.
              • Also discard cardboard juice/milk/baby formula boxes and home canned foods if they have come in contact with flood water, because they cannot be effectively cleaned and sanitized.
           2. Discard any food in damaged cans. Damaged cans are those with swelling, leakage, punctures, holes, fractures, extensive deep rusting, or crushing/denting that is severe enough to prevent normal stacking or opening with a manual, wheel-type can opener. See box on next page for steps to clean/save undamaged packages.
           3. Thoroughly wash metal pans, ceramic dishes, and utensils (including can openers) with soap and water, using hot water if available. Rinse and then sanitize them by boiling in clean water or immersing them for 15 minutes in a solution of 1 tablespoon of unscented household (5.25% concentration) liquid bleach per gallon of water.
           4. Thoroughly wash countertops with soap and water, using hot water if available. Rinse and then sanitize by applying a solution of 1 tablespoon of unscented household (5.25% concentration) liquid bleach per gallon of water. Allow to air dry.

           How To Save Undamaged Food Packages Exposed to Flood Water

         • Undamaged, commercially prepared foods in all-metal cans and “retort pouches” (like flexible, shelf-stable juice or seafood pouches) can be saved if you follow this procedure.
           1. Remove the labels, if they are the removable kind, since they can harbor dirt and bacteria.
           2. Brush or wipe away any dirt or silt.
           3. Thoroughly wash the cans or retort pouches with soap and water, using hot water if it is available.
           4. Rinse the cans or retort pouches with water that is safe for drinking, if available, since dirt or residual soap will reduce the effectiveness of chlorine sanitation.
           5. Sanitize cans and retort pouches by immersion in one of the two following ways:
              • Place in water and allow the water to come to a boil and continue boiling for 2 minutes.
              • Place in a solution of 1 cup (8 oz/250 mL) of unscented household (5.25% concentration) bleach mixed with 5 gallons of water and soak for 15 minutes.
           6. Air dry cans or retort pouches for a minimum of 1 hour before opening or storing.
           7. If the labels were removable, then re-label your cans or retort pouches, including the expiration date, with a permanent marking pen.

           Food in reconditioned cans or retort pouches should be used as soon as possible thereafter.

           Baby Formula Tip

           For infants, try to use prepared, canned baby formula that requires no added water. Otherwise, dilute any concentrated baby formula in reconditioned, all-metal containers with clean drinking water.

FDA

FDA takes new steps to protect food products from deliberate attacks

March 5, 2019

Media Inquiries

  Lindsay Haake
  301-796-3007

“The U.S. has one of the safest food supplies in the world. However, to keep it safe we must recognize that our foods can be vulnerable – not just from unintended contamination, but from those who would do us harm. We’ve taken steps to minimize the risk of an intentional attack on our food supply, and today we’re advancing new steps to help manufacturers implement additional activities that can help identify and mitigate the risk of intentional food adulteration. To secure these goals, in 2016 we put forth a rule outlining smart, risk-based steps food production facilities must implement to help protect our foods from acts of intentional adulteration. This is a serious issue that warrants serious attention and is why today we’re taking some additional steps to help ensure food facilities will implement the rule as effectively as possible,” said FDA Commissioner Scott Gottlieb, M.D. “When it comes to modernizing our approach to food safety, our core aim is to shift the FDA’s focus from reacting to food safety problems to preventing them from occurring in the first place. To help secure this goal when it comes to the risk of intentional adulteration and acts of terrorism, today we’re providing additional draft guidance to help producers implement the rule’s protective standards, identify their biggest risks, and mitigate these risks from those who might try to use food products to cause deliberate harm to American consumers.”

The U.S. Food and Drug Administration today released a revised draft guidance, “Mitigation Strategies to Protect Food Against Intentional Adulteration: Guidance for Industry,” to support compliance with the intentional adulteration (IA) rule set forth under the FDA Food Safety Modernization Act (FSMA).

The IA rule is designed to address hazards that may be intentionally introduced to foods, including by acts of terrorism, with the intent to cause widespread harm to public health. Unlike the other FSMA rules that address specific foods or hazards, the IA rule requires certain facilities – both domestic facilities and foreign facilities that export to the U.S. – to develop and implement food defense plans that assesses their potential vulnerabilities to such acts of deliberate contamination.

The draft guidance issued today outlines two, flexible methods for how facilities can conduct vulnerability assessments to identify their areas of highest risk and provides information about requirements for education and training. This installment of the draft guidance includes all of the information in the first installment, including information on the Key Activity Type method to conduct vulnerability assessments, mitigation strategies, and food defense monitoring procedures, released in June 2018.

In the near future, the FDA also intends to provide a third installment of this draft guidance that will include additional information on corrective actions, verification, records maintenance, reanalysis requirements, and how to calculate small and very small business sizes in order to determine what requirements of the rule are applicable. When finalized, this draft guidance is intended to be a resource that will help the food industry implement the IA rule’s provisions in a flexible and cost-effective manner. For more information on this guidance, as well as instructions on how to submit comments, please visit FDA.gov.

FDA

March 2019

Contains Nonbinding Recommendations

Draft-Not for Implementation

The FDA Food Safety Modernization Act (FSMA) added to the Federal Food, Drug, and Cosmetic Act (FD&C Act) several new sections that reference intentional adulteration.  For example, section 418 of the FD&C Act (21 U.S.C. 350g) addresses intentional adulteration in the context of facilities that manufacture, process, pack, or hold food, and that are required to register under section 415 (21 U.S.C. 350d).  Section 420 of the FD&C Act (21 U.S.C. 350i) addresses intentional adulteration in the context of high-risk foods and exempts farms except for farms that produce milk [2].

We implemented these intentional adulteration provisions through a rule entitled “Mitigation Strategies to Protect Food Against Intentional Adulteration” (IA rule).We published the final rule in the Federal Register of May 27, 2016.  (81 FR 34166).

The rule, which includes the requirements for food defense measures against intentional adulteration, and related requirements, can be found in 21 CFR part 121, as shown in Table 1.

Table 1. Subparts Established in 21 CFR Part 121

As shown in Table 2 below, the amount of time we are allowing you to comply with the IA rule depends on your particular business.

Table 2. Compliance Dates for IA Rule Based on Size of Business

The IA rule applies to the owner, operator, or agent in charge of a domestic or foreign food facility that manufactures/processes, packs, or holds food for consumption in the United States and is required to register under section 415 of the FD&C Act, unless one of the exemptions provided in 21 CFR 121.5 applies.  (21 CFR 121.1).

Acts of intentional adulteration may take several forms: acts intended to cause wide scale public health harm, such as acts of terrorism focused on the food supply; acts of disgruntled employees, consumers, or competitors; and economically motivated adulteration (EMA).  Acts intended to cause wide scale public health harm are associated with intent to cause significant human morbidity and mortality. The other forms are typically not intended to cause wide scale public health harm, although some public health harm may occur because of the adulteration.  For example, acts of disgruntled employees, consumers, and competitors are generally intended to attack the reputation of a company, and EMA is intended to obtain economic gain.  In the spectrum of risk associated with intentional adulteration of food, attacks intended to cause wide scale public health harm to humans are ranked as the highest risk.  Therefore, the IA rule is focused on addressing those acts and not acts of disgruntled employees, consumers, or competitors, or acts of EMA [3].

This document is directed to those persons who are subject to the Intentional Adulteration (IA) requirements of 21 CFR part 121 (you).  Identifying significant vulnerabilities at your facility and implementing mitigation strategies and mitigation strategy management components enables you to apply a proactive and systematic approach to your food defense program to protect your food from intentional adulteration intended to cause wide scale public health harm.

This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

Download the Draft Guidance for Industry

[1] This guidance has been prepared by the Office of Analytics and Outreach, Food Defense and Emergency Coordination Staff, in the Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration.

[2] The IA rule did not include any requirements for farms that produce milk. As such, farms that produce milk are not covered under this draft guidance.

[3] As we noted in the final rule, the protections required by the rule will help minimize the likelihood of success of a disgruntled employee, consumer, or competitor who attempts an act of intentional adulteration at an actionable process step—even if that act is not intended to cause wide scale public health harm. (81 FR at 34183).

FDA

The flu vaccine you get at your doctor’s office or pharmacy is the year-round work of highly skilled microbiologists, epidemiologists, physicians and other public health experts.

Sound complicated? It is.

The U.S. Food and Drug Administration (FDA) and the U.S. Department of Health and Human Services (HHS) are working toward developing new and better technologies for producing flu vaccines. As new strains of flu viruses emerge, the FDA works in close coordination with sister agencies, such as the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH), encouraging manufacturers to develop vaccines that will successfully protect us from influenza disease, which can be a very serious illness.

The more diverse the influenza vaccine supply, the better we can respond to flu public health emergencies in a timely manner. All U.S. licensed flu vaccines have been evaluated and determined to be safe and effective by the FDA.

There is often more than one type of influenza virus circulating each season, so influenza vaccines are formulated to target three or four of the most likely influenza viruses of the season: two influenza A types (H1N1 and H3N2) and one (trivalent vaccine formulation) or two (quadrivalent vaccine formulation) types of influenza B.

Influenza Vaccines and How They Are Made

Influenza (flu) vaccine works by triggering your immune system to produce antibodies that help the body prevent the flu.

Most of the U.S. influenza vaccine supply is made using an egg-based production process. In this method of making influenza vaccines, manufacturers use fertilized eggs to grow flu viruses. After about six months of laboratory work and manufacturing, those viruses are incorporated into that season’s flu vaccine. While this method produces safe and effective vaccines, FDA, HHS, and manufacturers have been working on different technologies to increase the influenza vaccine supply, making sure to still maintain safety and effectiveness. Some technologies have the potential to produce these vaccines faster and less labor-intensively.

For example, more recent approvals include influenza vaccines that do not use an egg-based production process for manufacturing. In addition, quadrivalent vaccines, which protect against two influenza A strains and two influenza B strains, have been available for several years. Quadrivalent vaccines provide protection against the two lineages of influenza B strains, both of which circulate each flu season. This is important, particularly for preschool and school-age children who get Influenza B more often than adults do. Influenza B also causes more complications and fatalities in children than adults.

In addition, the FDA has approved a high-dose and an adjuvanted vaccine specifically for people ages 65 and older, who typically bear the greatest burden of severe influenza disease and account for most of influenza-related hospitalizations and deaths. Adjuvants are incorporated into some vaccine formulations to enhance the immune response of the vaccinated individual.

Making the Flu Vaccine: A Year-Round Effort

The job of producing a new vaccine for the next flu season starts well before the current flu season ends. For the FDA, it’s a year-round initiative.

The composition of vaccines for the prevention of other infectious diseases stays the same year after year. In contrast, flu viruses are constantly evolving. And the flu viruses that circulate causing disease in people, often change from one year to another. So, every year, there is a need for a new flu vaccine. To that end, FDA, World Health Organization (WHO), CDC, and other partners collaborate by collecting and reviewing data on the circulating strains of influenza from around the world to identify those likely to cause the most illness in the upcoming flu season.

In late February/early March — well before the new flu season begins — an FDA advisory committee reviews data about which flu viruses have caused disease in the past year, how the viruses are changing, and disease trends so they can recommend the three or four flu strains to include in the trivalent and quadrivalent influenza vaccines for the U.S in the upcoming flu season.

Once the strains are selected, vaccine manufacturers begin the manufacturing process to include the newly selected flu strains in their FDA-approved vaccines. The different flu virus strains are combined to formulate the vaccine into standard dosages. The vaccine is then filled into vials, syringes and, for the nasal vaccine, sprayers. Both egg-based and non-egg-based manufacturing methods for FDA-approved flu vaccines require high-tech processes and manufacturing facilities that have been inspected by the FDA. Vaccine manufacturers must submit applications to the FDA to include the new flu strains in their FDA-approved vaccines.

In its own laboratories, the FDA also produces materials that are critical for making the vaccine. These include generating candidate vaccine virus strains suitable for further vaccine manufacture and producing the critical potency reagents, which are materials needed to test the vaccines for potency and identity (to ensure standardization) before the FDA approves the new formulation of the approved seasonal influenza vaccines for U.S. distribution.

The FDA is also responsible for ensuring that released lots of influenza vaccines meet appropriate standards. Each vaccine undergoes quality control tests, including testing for sterility. Manufacturers submit the results of their testing, along with sample vials from each lot to the FDA for “lot release.” The FDA typically begins releasing lots of flu vaccines in late summer. Lot release can continue into early fall. Once lots are released, manufacturers distribute the vaccine throughout the United States for use by the public.

Flu seasons and severity are unpredictable. Annual vaccination is the best way to prevent the flu for people ages 6 months and older.

An annual immunization with flu vaccine is the most effective and safest way for most of us to reduce our risk of getting the flu and spreading it to others. When more people get vaccinated, it is less likely that the flu viruses will spread through a community, making us all healthier.

Updated: March 1, 2019

The flow chart below provides a summary of the process for Emergency Use Authorization (EUA) issuance.

Description of chart:

Issuance of an EUA by the FDA Commissioner requires several steps under section 564 of the FD&C Act. First, one of the four following determinations must be in place:

1. The Department of Defense (DoD) Secretary issues a determination of military emergency or significant potential for military emergency
2. The Department of Homeland Security (DHS) Secretary issues a determination of domestic emergency or significant potential for domestic emergency.
3. The Department of Health and Human Services (HHS) Secretary issues a determination of public health emergency or significant potential for public health emergency
4. The DHS Secretary issues a material threat determination

After one of the above four determinations is in place, the HHS Secretary can issue a declaration that circumstances exist to justify issuing the EUA.  This declaration is specific to EUAs and is not linked to other types of emergency declarations.

The FDA Commissioner, in consultation with the HHS Assistant Secretary for Preparedness and Response (ASPR), Centers for Disease Control and Prevention (CDC), and the National Institutes of Health (NIH), can then issue the EUA, if criteria for issuance under the statute are met.  FDA publishes public notice of each EUA that is issued in the Federal Register.

The last step in the process is termination of declaration and EUA, if appropriate and needed.

FDA

The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of MCMs needed during public health emergencies.

Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when there are no adequate, approved, and available alternatives.

Section 564 of the FD&C Act was amended by the Project Bioshield Act of 2004 and the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), which was enacted in March 2013

Current EUAs

The tables below provide information on current EUAs:

• Anthrax: Doxycycline Mass Dispensing EUA Information and National Postal Model Anthrax EUA Information
• Ebola Virus EUA Information
• Enterovirus D68 (EV-D68) EUA Information
• French Freeze Dried Plasma Information
• H7N9 Influenza EUA Information
• Middle East Respiratory Syndrome Coronavirus (MERS-CoV) EUA Information
• Nerve Agent EUA Information
• Zika Virus EUA Information

FDA

FDA authorizes emergency use of first Ebola fingerstick test with portable reader

For Immediate Release

FDA

FDA

FDA In Brief: As part of a longstanding program encouraging the development of medical countermeasures; new FDA policy promotes innovation to thwart inhalational anthrax

May 23, 2018

Media Inquiries

  Tara Rabin
  240-402-3157

“The FDA has long played an important role preparing our nation for potential bioterrorism threats, providing guidance and support around the development of medical countermeasures that can be used safely, effectively and reliably during public health emergencies,” said FDA Commissioner Scott Gottlieb, M.D. “Since the 2001 anthrax attacks, the U.S. government’s efforts to protect the nation from bioterrorism threats have continued to evolve. We now know that a comprehensive preparedness plan for potential anthrax threats must account for both pre- and post-exposure scenarios. That’s why the FDA has taken steps to modernize its guidance on inhalational anthrax to advance the development of new drugs for prophylaxis, prior to exposure. This builds upon the treatments that are currently available for inhalational anthrax and advances the agency’s longstanding commitment to the development of a full suite of medical countermeasures as part of its established programs.”

The U.S. Food and Drug Administration today issued final guidance, Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax, which is designed to assist in the development of drugs for prophylaxis (prevention) of inhalational anthrax for individuals who may be potentially exposed to or have inhaled aerosolized Bacillus anthracis (B. anthracis) spores, but who have not yet displayed related signs and symptoms.

While there are FDA-approved drugs for treatment of anthrax and for post-exposure prophylaxis of inhalational anthrax, situations can arise where starting therapy immediately before the anticipated or potential exposure can reduce the risk of illness and death (for example, first responders who anticipate an imminent risk of exposure to B. anthracis spores).

The FDA’s final guidance is the result of a multi-year effort to advance its policy framework for the development of treatments targeting inhalational anthrax. The final guidance revises the indication to “prophylaxis of inhalational anthrax” for the reduction of disease risk in those who have inhaled, or are likely to inhale, aerosolized B. anthracis spores, but who do not yet have established disease.

Clinical trials in humans cannot be conducted since naturally occurring inhalational anthrax is extremely rare and it would be unethical to deliberately expose healthy human volunteers to B. anthracis spores. Therefore, the final guidance clarifies that drugs developed for the prophylaxis of inhalational anthrax can rely on evidence from animal studies (known as the Animal Rule) to support approval when the criteria under the Animal Rule have been met.

The FDA encourages drug developers to reference the final guidance issued today when designing studies to appropriately establish the safety and effectiveness of drugs for prophylaxis of inhalational anthrax.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.