1. Tracking the FSMA
by Kristina Hernandez, Esq.
For Companies Importing Food into the US

2. What is the FSMA
• The FSMA, or the Food Safety • TITLE III is the most relevant to
Modernization Act is a imported foods, but some
comprehensive Act that was signed
into law in 2011. It is the first major provisions in other titles are also
amendment in almost 75 years to relevant, and will be discussed in
the food safety regulations of the this presentation (such as Sec 201).
Food Drug and Cosmetic Act.
• The FSMA will have immense
• It is comprised of 4 separate Titles
ramifications for companies that
import food to the US as well as for
TITLE I: IMPROVING
CAPACITY TO PREVENT domestic companies that use
FOOD SAFETY foreign suppliers in their domestic
PROBLEMS product.
TITLE II: IMPROVING
CAPACITY TO DETECT
AND RESPOND TO • The FSMA is large in scope, but its
FOOD SAFETY primary purpose can be summed
PROBLEMS up in one sentence, it seeks
TITLE III: IMPROVING THE transform the US food safety
SAFETY OF IMPORTED system from a reactive one to a
FOOD proactive one – to prevent food
safety breaches, not just address
TITLE IV: them after they have occurred.
MISCELLANEOUS PROVISIONS

3. Implementation of the FSMA
• The FSMA will take several years to fully implement
• Though the Act was signed into law in January of
2011, its full implementation will require FDA to
promulgate various regulations
• And although it was passed by the US Congress, it
will have a profound effect on food systems outside
the US because it regulates foods imported into the
US and imposes various new requirements on these
imported foods.

4. the meat and bones
the regulations
the FSMA

5. How long will it take to
implement the FSMA
• In the Act itself, Congress established specific implementation dates,
some provisions took effect immediately, others were given specific
future dates
• Some authorities will go into effect quickly, such as mandatory recall
authority, while others require FDA to prepare and issue regulations
and guidance documents – these will take longer to implement.
• It will take several years before FSMA is fully implemented and the
process will be dynamic, as FDA will work with stakeholders in developing
many of the requirements. FDA will also need proper funding to carry out
its authority and enforce these regulations.
• Implementing FSMA will be a complex process and companies should
invest in help from consultants or attorneys who can help them
understand and comply with FSMA as it slowly becomes integrated into
the US and foreign food system

6. Special concern for medium to small
food companies
• While most large companies may be able to undertake the extra work mandated by FSMA,
these new requirements could overwhelm small- and mid-sized companies, making it harder for
them to compete.
• ―The costs to small- and mid-sized importers will likely become severe in coming years, regardless
of any exemptions that FDA might hand out to them,‖ said Benjamin England, chief executive of
FDA IMPORTS.COM. ―These companies simply don’t have the relations with foreign suppliers
necessary to implement the statutory language. This will cost U.S. jobs, reduce competition, and
produce more very large food companies, which is not necessarily better when it comes to food
safety,‖ he added.
• One of the main ways this can happen is through product detention. Running afoul of FSMA
requirements can result in products being placed on the FDA Import Alert list. The Import Alerts
instruct import inspectors, investigators, and compliance officers to automatically detain or
detain without physical inspection all imports of affected products from the listed manufacturer,
shipper, grower, or even geographic area. Once a product or company is placed on the list, it
can be very challenging to convince the FDA that the violation has been corrected. While the
Import Alert List is not new, FSMA does impose many new requirements, so there will be more
opportunities for companies to violate a requirement and end up on an Import Alert List.
• However, there are consultants, attorneys and companies available to help, medium and small
food companies comply with FSMA.
• For example, FDA Solutions Group based in Miami,, Florida and attorney Marc Sanchez, just to
name a couple

7. Funding is also an issue
Not only will it take several years and stakeholder input to
flesh out the implementation of FSMA, but funding will also
be a challenge.
The funding FDA has available through the annual budget
cycle and fees impacts the number of employees they
have and will be a factor in the way that FDA handles its
significant and far-ranging activities, including the way that
this legislation is implemented.
For example, the inspection schedule in the legislation
would increase the burden on FDA’s inspection functions.
But without additional funding, FDA will be challenged in
implementing the legislation fully without compromising its
other responsibilities.

8. Implementation delays, caused in part by
On a side note
funding shortages, have even spurred two
groups to file a law suit in federal court against
FDA and the Office of Management and
Budget for delays in implementing FSMA
In August of 2012, the Center for Food Safety
and the Center for Environmental Health filed
their joint petition. The lawsuit seeks a court
order that requires FDA to enact the FSMA
regulations by a court-imposed deadline and
prevents OMB from delaying FDA compliance
with that deadline.
In December of 2012, FDA filed a motion to
have the law suit dismissed, stating that
although it was behind schedule in adopting
the mandated regulations, the agency’s broad
role in regulating a $450 billion domestic and
imported food business requires additional time.
"The enormity and scope of the task given to
FDA cannot be overstated," the FDA said in a
motion filed Friday in U.S. District Court for the
Northern District of California.

9. With so much uncertainty
about the FSMA, do I need
to do anything right now?
• Companies should take a nuanced approach to compliance,
• on the one hand, there is no need to become overwhelmed and
thus paralyzed by the sheer volume, novelty, and scope of FSMA –
FDA and others are preparing resources to help companies wrap
their minds around this comprehensive Act and the regulations that
will follow
• But by the same token, companies cannot continue with business as
usual, the law will bring about changes for all food companies and
companies should invest resources into compliance, because the
FSMA represents a sweeping change to the US and even foreign
food systems. it will change the way food businesses operate, both
those in the US and those that want market share in the US

10. Record Keeping…one area in particular that may
catch many companies off guard, is record keeping
• Many companies believe they create and maintain the proper records and have a
good document control system in place to support their food safety programs.
• But these may not be enough. ―These companies need to go back and really
understand how their standard operating procedure is being implemented and
consistently executed across all their facilities. They need to understand that
anything going back two years will be fair game.‖ said Dr. Craig W.
Henry, PhD, director of enterprise risk services-business risk at Deloitte & Touche LLP
• Under FSMA Section 201, the FDA is required to significantly increase the frequency
of its domestic and foreign inspections. ―FDA inspectors are limited, and they can
only spend so much time in plants during routine inspections. But by looking at
records, they can identify areas for further investigation,‖
• On-site inspections are burdensome, but inspecting records is less
burdensome, therefore, the FDA may begin asking for extensive records – for
example, not just the certificate of a third-party audit, but also the entire audit itself.
―
• The key concept is ―business continuity‖ of the entire supply chain—from field to
restaurant or retail grocer. ―The challenge for industry now is validating the integrity
of the food safety systems being used to supply their upstream supply chain,‖ Dr.
Henry said. Instead of relying on third parties to certify ingredients, companies will
need to be more aggressive and invest more time and money, especially if the
external supply chain is important to their brand. ―They really need to make sure
they know what’s going on and not assume all is well, especially with FDA
inspections picking up,‖ he said.

11. In the first
year, 2011, FDA has…
Below is a brief summary of what FDA accomplished in 2011:
- Issued interim final rules on criteria for administrative detention and
used this authority three times
- issued interim final rules on prior notice of imported food.
- Issued guidance to the seafood industry on food safety hazards and
to the dietary supplement industry regarding new dietary
ingredients.
- Conducted extensive domestic and foreign outreach to all
stakeholders to receive input in developing the proposed preventive
control rules.
- Established the Produce Safety Alliance and the Food Safety
Preventive Controls Alliance.
- Met the FSMA mandate for foreign food safety inspections, and is
well on its way to meeting the 5-year inspection frequency mandate
for high-risk domestic food facilities.
- Continued to build State-Federal and global partnerships.

12. In the second year,
2012, FDA has…
Below is a brief summary of what FDA accomplished in 2012:
Because the records access provisions of FSMA (Section 101) which amend
section 414(a) and 704(a)(1)(B) of the FD&C Act became effective on passage
in 2011, FDA decided to issue an interim final rule to expedite industry’s
understanding of and compliance with records access provisions. In addition
to the interim final rule, FDA also published draft guidance and questions
and answers for industry. The FSMA amendment simply expands FDA’s
former records access beyond records related to the specific suspect article of
food which FDA reasonably believes is adulterated and presents a threat of
serious adverse health consequences or death to humans or animals, to now
include records relating to any article of food that is reasonably likely to be
affected in a similar manner. In addition, the FSMA amendment permits FDA
to access records related to articles of food for which FDA believes that there
is a reasonable probability that the use of or exposure to the article of food,
and any other article of food is likely to be affected in a similar manner, will
cause serious adverse health consequences or death to humans or animal.
Once either of the above mentioned circumstances are met, FDA may request
all existing records needed to assist the agency in determining whether the
circumstances, which gave rise to the records request, exist.

13. In the second year, 2012,
FDA also…
• FSMA requires FDA to issue a number of reports to Congress on various topics. FDA
issued its latest report, ―Report to Congress on FDA Foreign Offices,‖ in February,
2012. The report describes the Agency’s progress in establishing its foreign offices – 13
to date – as well as their accomplishments and the challenges faced by FDA in the
increasingly globalized marketplace it oversees.
• FDA announced the types of foods that will be part of the pilot projects on product
tracing.
• A Frequently Asked Question and Fact sheet describe how FDA identifies a high-risk
facility and how this approach will be updated.
• FDA announced that it had submitted to the Office of Management and Budget for
review a survey it intends to field of 1,400 state and local agencies to assess state
and local food safety capacity. FDA is required under FSMA to make a report to
Congress on the needs for enhancement in the areas of staffing levels, laboratory
capacities and information technologies at the state and local levels.
• FDA released an updated draft guidance to notify industry of additional food
categories that may be included in the food facility registration form as mandatory
fields, as provided by FSMA, including food categories that were previously listed in
the form as optional fields.

14. • FDA announced the availability of the FSMA domestic and foreign facility
reinspection, recall and importer reinspection fee rates. These fees are
effective on October 1, 2012, and will remain in effect through September
30, 2013.
• FDA released an updated Guidance for Industry: Necessity of the Use of
Food Product Categories in Food Facility Registrations and Updates to Food
Product Categories. This guidance represents FDA’s conclusion on the
necessity of food product categories in food facility registrations submitted
to the FDA under section 415 of the Federal Food, Drug, and Cosmetic
(FD&C) Act, as added by section 305 of the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002 and amended by
section 102 of the FDA FSMA.
• On October 22, FDA announced its updated food facility registration system
is available for biennial registration renewal. Registrants can submit
registration renewals to FDA using the online food facility registration
module or paper Form FDA 3537. The agency is offering technical
assistance online and through the help desk.
• On November 26, FDA announced that to protect the public health, it had
suspended the food facility registration of Sunland Inc., a producer of nuts,
and nut and seed spreads. The fact that peanut butter made by the
company had been linked to an outbreak of Salmonella Bredeney that
sickened more than 41 people in 20 states, coupled with Sunland’s history of
violations, led FDA to make the decision to suspend the company’s
registration. This was FDA’s first use of its registration suspension authority
under section 102 of FSMA.
• FDA announced the availability of the FSMA domestic and foreign facility
reinspection, recall and importer reinspection fee rates. These fees are
effective on October 1, 2012, and will remain in effect through September
30, 2013.

15. • FDA released an updated Guidance for Industry: Necessity of the Use of Food
Product Categories in Food Facility Registrations and Updates to Food Product
Categories. This guidance represents FDA’s conclusion on the necessity of food
product categories in food facility registrations submitted to the FDA under
section 415 of the Federal Food, Drug, and Cosmetic (FD&C) Act, as added by
section 305 of the Public Health Security and Bioterrorism Preparedness and
Response Act of 2002 and amended by section 102 of the FDA FSMA.
• On October 22, FDA announced its updated food facility registration system is
available for biennial registration renewal. Registrants can submit registration
renewals to FDA using the online food facility registration module or paper Form
FDA 3537. The agency is offering technical assistance online and through the
help desk.
• On November 26, FDA announced that to protect the public health, it had
suspended the food facility registration of Sunland Inc., a producer of nuts, and
nut and seed spreads. The fact that peanut butter made by the company had
been linked to an outbreak of Salmonella Bredeney that sickened more than 41
people in 20 states, coupled with Sunland’s history of violations, led FDA to
make the decision to suspend the company’s registration. This was FDA’s first
use of its registration suspension authority under section 102 of FSMA.

16. • FDA issued updated Guidance for Industry: What You Need to Know
About Registration of Food Facilities; Small Entity Compliance
Guide, to reflect the FSMA amendments to the FD&C Act. It contains
information regarding: who is required to register and who may be
exempt; how often facilities must register and renew registrations;
when FDA may suspend a registration; and how facilities may submit
their registrations and registration renewals to FDA.
• On December 10, FDA and New Zealand’s Ministry for Primary
Industries signed an arrangement recognizing each other’s food
safety systems as comparable to each other. This arrangement
complements the expanded import tool kit mandated under FSMA
and leads the way to a new level of regulatory cooperation to
enhance food safety while facilitating trade between the two
countries. This is the first time that FDA has recognized a foreign food
safety system as comparable.

17. Most important as of December 2012
While this presentation cannot address every applicable component of the FSMA
for your business, here are three areas that are almost certainly amongst the most
pressing and relevant right now
1) Determine if the FSMA applies to you, and what parts apply to you
FSMA governs food products regulated by the FDA; it does not apply to meat, poultry or egg
products regulated by the USDA. The new law grants additional power to, and also places
additional requirements on, the FDA. However, certain provisions of FSMA will not apply to some
companies.
2) The biennial facility registration
Food companies must register with the FDA biennially, between October 1 and December 31 of
each even-numbered year. There is no fee.
3) Adjust your record keeping system
Food companies must maintain, for not less than 2 years, records documenting the monitoring of the
preventive controls, instances of nonconformance material to food safety, the results of testing and
other means of verification, corrective actions, and the efficacy of preventive controls and
corrective actions. These records must be made available to FDA upon request.
4) Foreign Importer Verification Program
Under the FSMA, effective January 4, 2013, importers must verify the safety of the food offered for
import using the new Foreign Supplier Verification Program (FSVP). (The requirement doesn't apply to
firms that import products from foreign suppliers subject to low-acid canned food
regulations, seafood or juice HACCP.) Under this plan, every subject importer must establish a
program through which it verifies that its foreign supplier complies with HARPC or Standards for
Produce Safety, and also verifies that that the food is not adulterated and misbranded because it
fails to disclose the presence of major food allergens. Importers must maintain records for two years
that substantiate compliance with this requirement. Importers that fail to comply with this verification
program violate FDCA and are prohibited from importing food into the United States.

18. 2013
• FDA Issues Two Major Proposed FSMA Rules on
January 4, 2013
• Preventive Controls for Human Food: Fact Sheet on
the Proposed Rule
• Standards for Produce Safety: Fact Sheet on the
Proposed Rule

19. Proposed Rule for
Produce Safety
FDA has released for public comment a proposed rule on Preventive Controls for Human Food and a proposed rule on
Standards for Produce Safety. These rules are two of the proposed rules that are key to the preventive food safety
approach established by the Food Safety Modernization Act. The proposed rules build on existing voluntary industry
guidelines for food safety, which many producers, growers and others currently follow.
• Proposed Standards for Produce Safety
• The proposed produce rule covers all fruits and vegetables except those rarely consumed raw, produced for
personal consumption, or destined for commercial processing that will reduce microorganisms of public health
concern. The proposed rule is based on science and risk-analysis, and therefore focuses on areas of risk, most
noticeably:
• agricultural water;
• biological soil amendments;
• health and hygiene;
• domesticated and wild animals; and
• equipment, tools and buildings.
• The proposed produce rule is the result of extensive outreach by FDA with
consumers, government, industry, researchers, and many others. The proposed rules build on existing voluntary
industry guidelines for food safety, which many producers, growers and others currently follow. The produce rule is
aimed at being flexible for different-sized farms, at complementing conservation laws and rules, and at not
conflicting with laws and rules for organic farming.
• Certain farms would be exempt from most of the requirements if their sales average less than $500,000 per year
during the last three years (adjusted for inflation) and their sales to qualified end-users exceed their sales to others
during the same period.
• The exemption can be revoked under certain circumstances. In addition, farms whose average annual value of
food sold during the previous three-year period is $25,000 or less would not be covered by the rule. Such farms
would still be responsible for the safety of their produce. In addition, states and foreign countries can seek
variances from provisions of the rule because of local growing conditions.
• While the effective date for this rule would be 60 days from publication of the final rule, the general compliance
date would be two years after the effective date. For small businesses, the compliance date would be three
years after the effective date, and for very small businesses four years after the effective date. Additional time
would be allowed for compliance with certain water requirements.

20. Preventative Controls for
Human Food
The proposed rule on preventive controls for human food would apply to
facilities that manufacture, process, pack or hold human food. In general,
with some exceptions, the new preventive control provisions would apply to
facilities that are required to register with FDA under FDA’s current food
facility registration regulations. A number of exemptions and modified
requirements have been established.
• The rule proposes firms have written plans in place to identify potential
hazards, put in place steps to address them, verify that the steps are
working, and outline how to correct any problems that arise.
• The rule proposes each covered facility to prepare and implement a
written food safety plan, which would include the following:
• hazard analysis;
• risk based preventive controls;
• monitoring procedures;
• corrective actions;
• verification; and
• recordkeeping

21. Further Presentations to Follow
To contact me, please email me at
Kristy0703@gmail.com