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January 2011

FDA Food Safety Modernization Act:


The President signs the most sweeping over-
haul of food-safety legislation since 1938.

Food Safety Series


Companies at every link in the food chain may need to take additional steps to prevent
food-borne illness.

Highlights Food-safety standards aim to reflect today’s vastly different food


• The bill will usher in a new era manufacturing and distribution system.
of food-safety regulation, with The legislation was prompted by changes in the food supply and
increased enforcement, stiffer outbreaks of food poisoning in recent years involving eggs, tainted
penalties and broader record-
keeping requirements for high peanut butter, cookie dough and fresh bagged spinach that
risk food. sickened hundreds of people across the country.
• The legislation requires food
manufacturers and processors The legislation requires risk-based assessments to inform food
to develop and document food- safety plans.
safety plans that identify and The planning, testing and documenting controls over food safety
prevent hazards at each facility.
could be strongly enforced. Recall procedures and defense from
• These companies also may intentional contamination could also be required.
need to do more to verify
the safety of the ingredients
A change in mindset in the food industry will be necessary.
they use.
Growers, food manufacturers and processors, importers,
restaurants, and food retailers may all face new mandates that
could require a change in mindset at the highest level to ensure
a culture of food safety.
Background

Responding to The legislation is an important step in


updating America’s antiquated food-
The FDA, which oversees 80% of the
food supply, is currently developing new
the realities of safety laws. standards for safely growing, harvesting
and packing fresh fruit and vegetables. The
today’s food The new legislation was proposed partly
in response to high-profile outbreaks of
FDA also is gearing up to propose rules on
the sanitary handling of food by companies
supply chain food poisoning in recent years that have
undermined public confidence in the
that transport it in bulk.

nation’s food supply. Eggs, peanut butter, Significant features of the legislation
cookie dough, spinach, hot peppers include:
and green onions are among the foods 1. Companies that now register with the
that have been found to be tainted with FDA, as required under the Bioterrorism
Salmonella, E. coli or other pathogens. Act of 2002, will be required to perform
an analysis of food safety hazards that
The Centers for Disease Control estimates are reasonably likely to occur in each
that there are 48 million cases of food- facility, implement controls to prevent
borne illnesses in the US each year, these hazards, monitor the controls
resulting in 128,000 hospitalizations and to ensure that they are working and
over 3,000 deaths. correct them if they aren’t. The entire
plan will have to be documented and
Two trends have made the food supply updated every two years or sooner if the
chain more vulnerable to outbreaks of company changes suppliers, processes
food-borne illnesses in the US and other or ingredients. Companies will be
developed economies: the centralization required to share their food-safety plans
of food production and distribution and with FDA upon request.
Tracing food is tough the rapid growth of imports of food and 2. Registered companies will be required
Results of an effort to trace 40 food products ingredients from countries where safety to maintain documents for a minimum
purchased at stores back to the farm or
standards or enforcement is weak. Today, of two years and could be subject to
the border:
imports account for 15% of the US food expanded record-keeping requirements
supply, including 80% of the seafood for higher-risk food.
Food products
Americans consume and 50% to 60% of
3. These companies will be required to
the fresh produce.
Traceable through develop food defense plans aimed at
each stage of the 5 The nature of today’s food supply chain preventing intentional contamination
food supply chain
means contamination can turn up in for food determined to be high-risk.
more products, more quickly than in the 4. Importers will have to ensure that
Identified facilities
that likely handled the
past, causing outbreaks that affect large all food coming into the US meets
product but could not 31 numbers of people. Tainted milk products FDA food-safety standards under the
trace through each stage
from China, for example, wound up in Food, Drug, and Cosmetic Act. FDA
of the food supply chain
candy sold in the US. And last year’s regulations will likely result in more
Salmonella outbreak linked to Peanut third-party audits.
Could not identify Corporation of America led to the recall of 5. Entry of imported food products into
even facilities that likely 4 more than 3,900 foods that used its peanut
handled the product the US may be expedited based, in part,
products as ingredients, including peanut on the facilities’ compliance history,
butter crackers, cookies, ice cream, granola the exporting country’s food-safety
0 40
bars, dog treats and packaged kung pao standards and regulatory capacity, and
Source: Office of the Inspector General, Department of Health chicken. This year, more than 100 foods, third-party certifications, among other
and Human Services, Traceability In the Food Supply Chain,
March 2009.
including salad dressing, dips and snack things. This could ease the burden on
mixes, were recalled because they had importers and food manufacturers.
been made with a flavor enhancer called
hydrolyzed vegetable protein that might
have been contaminated with Salmonella.

2 PwC Point of view


Analysis

Raising Food companies take safety very seriously,


but given the nature of today’s supply
check on safety procedures used by
suppliers. Some companies limit the
standards to chains, they may need more stringent
controls to avoid unpleasant surprises.
number of suppliers so officials can visit
them regularly. Some provide training
protect your The legislation will set minimum
standards. Companies rightly aim to
for suppliers and require them to have
systems in place to trace ingredients
brand meet higher standards and go beyond
compliance in order to win the loyalty
they use. Leading companies realize that
having a world-class supply chain can
of consumers and investors and gain a give them a competitive advantage.1
competitive advantage.
4. Food defense plans: Measures to
prevent intentional contamination
Here are the leading practices used by include limiting access to key points in
regulators and the private sector. production, doing background checks
1. Analysis of safety hazards: Leading on employees, using tamper-resistant
companies already employ food packaging and requiring delivery trucks
safety plans of the type that would be to be sealed.
required. The approach, called Hazard
5. Traceability and recall procedures:
Analysis and Critical Control Point
Leading companies have sophisticated
(HACCP), is accepted by regulators
electronic systems to track contaminated
and trade associations around the
foods quickly when problems arise.
world. Restaurants and retailers also
They also conduct mock recalls to test
have had success with it. In the US, the
their ability to move quickly. The US
FDA has used it to reduce outbreaks of
produce industry is implementing a
food-borne illness associated with juice
traceability initiative that uses bar codes
since 2001. The record is less clear on
on each case to track the movement of
Test your food seafood, where the FDA has required
produce electronically. Some companies
traceability practices food safety plans since 1998, but the
use radio frequency identification tags.
US Department of Agriculture, which
The government of Thailand also is
regulates meat and poultry, has reduced
testing an electronic tracking system.
Are your records Do you track the food-borne illnesses by requiring
in electronic date and time But tracing ingredients can be difficult,
HACCP plans. Leading companies also
form rather than that a lot was and companies spend millions of dollars
conduct internal safety audits that are
paper-based? harvested or recalling and destroying products that
reviewed by senior executives.
manufactured? might contain a tainted ingredient.
2. Training: Training is widely recognized
6. Certification of international foods:
as a key to food-safety programs,
Food companies and suppliers around
and independent evaluations of both
the world may be certified by third-party
Can you share Do you track lot training and the program itself can lead
data seamlessly numbers and auditors, who use standards approved
to improvements. In China, where food
with other firms? sources of all by the Global Food Safety Initiative or
safety laws were strengthened last year
ingredients used other groups.
but enforcement gaps remain, the China
to manufacture Companies that aspire to be market
Chain Store & Franchise Association
a product?
is working with the UK’s Chartered leaders can start by reviewing their food
Institute of Environmental Health safety plans, training programs and
to adapt food safety courses to meet supply chains, with an eye toward making
Based on recommendations of the
Institute of Food Technologists the new requirements and encourage improvements. External assessments
members to have their managers and can help.
workers take these courses.
3. Ingredient safety: Leading companies
test high-risk ingredients and require 1 From vulnerable to valuable: how integrity can transform
a combination of internal audits and a supply chain, http://www.pwc.com/us/en/supply-
chain-management/publications/supply-chain-report-
well-executed third-party audits to download.jhtml.

PwC Point of view 3


Companies need to act now Q: Are there gaps in the legislation?
A: Very small businesses and farms that
to avoid putting their brands market directly to consumers are subject
to modified requirements for some of
at risk the proposed new rules, yet even small
farms can be sources of significant
national food-safety problems. That was
demonstrated by a 2006 E. coli outbreak,
which was linked to a small lot of spinach
Q&A from California, and the 2008 hot pepper
outbreak that was linked to a small farm in
Q: Why do CEOs and board members pay Mexico. It is unclear whether the final rules
attention to food-safety rules? will give regulators the ability to quickly
A: Making people sick can literally kill track tainted foods all the way from the
your company. That’s what happened to store or restaurant back to the farm.
Peanut Corporation of America, which
Q: Why do I need to act now if it will
shipped products contaminated with
take the FDA a few years to write any
Salmonella, leading to one of the largest
new rules?
food recalls in US history. More than 700
people in 46 states got sick, and nine A: Reviewing your company’s food-safety,
died. The firm filed for bankruptcy, and a record-keeping and product-tracking
criminal investigation was launched. At procedures can lead to performance
the very least, selling contaminated food improvements and innovation. By being
can damage your reputation and hurt your in the forefront of efforts to improve food
stock price. Recent recalls have cost the safety and providing credible information
food industry tens of millions of dollars. to regulators and consumers, companies
With public scrutiny of food safety on the can get a leg up on the competition. They
rise, you could even be called to testify can even influence any new rules.3
before Congress.
Q: If I comply with any new rules, will I
Q: What is the biggest risk companies face? stay out of trouble?
A: The biggest unknown is the safety A: Not necessarily. The legislation raises
of your supply chain, and the risks rise the minimum standards for food safety,
if you use suppliers in countries where meaning there could still be outbreaks.
food-safety laws or enforcement is weak. Your customers, however, expect the food
Leading companies take steps to prevent you produce, sell or serve to be safe. And
problems. CEOs can set the tone by asking that expectation is likely to rise. Setting a
what is being done to track suppliers, who higher standard will help your company
may be changing processes or ingredients achieve its mission of better serving
and putting the brand at risk. Tracking the your customers.
financial health of suppliers can help you
identify potential risks.2 2 10Minutes on Supply Chain Risk Management, http://
www.pwc.com/us/en/10minutes/supply-chain-risk-
management.jhtml.
3 10Minutes on Trust and Transparency, http://www.pwc.com/
US/en/10minutes/trust-and-transparency.jhtml.

Contact information
For a deeper discussion of how food safety might affect your business, please contact: © 2011 PricewaterhouseCoopers LLP. All rights
reserved. In this document, “PwC” refers to
Carter Pate Susan McPartlin PricewaterhouseCoopers (a Delaware limited
liability partnership), which is a member firm of
Global Government & Infrastructure Retail and Consumer Products PricewaterhouseCoopers International Limited, each
PricewaterhouseCoopers LLP PricewaterhouseCoopers LLP member firm of which is a separate legal entity. This
703-918-1111 513-361-8094 document is for general information purposes only,
and should not be used as a substitute for consultation
with professional advisors. NY-11-0257_B
Leavitt Partners Kristen Vieira Traynor
www.leavittpartners.com Global Food Safety © Copyright 2011, Leavitt Partners, LLC.
801-538-5082 PricewaterhouseCoopers LLP All rights reserved.
267-330-2530

4 PwC Point of view