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Make Sure Your Label Application Is Correct
By Kurtis Calhoun
The Small Plant Help Desk at the U.S. Department of Agriculture's (USDA) Food Safety and Inspection Service (FSIS) has been
receiving a significant number of questions on labeling issues. One of the most common questions is why many establishments
are still having problems when submitting their product's label application for approval. Here is a recap of the simple steps
you can take, as previously discussed in Small Plant News, Volume 2, Number 9,
to ensure that your label application is approved.
To start, make sure you complete all of the 12 sections required on the application, FSIS Form 7234-1, Application for Approval
of Labels, Marking or Device. The sections may be handwritten as long as it is legible; however, it is strongly recommended
that the form be typed. Remember to sign in the designated areas.
Along with your application, you will need to prepare a "sketch label" and any supporting documentation about the product's
required labeling features. A "sketch label" is a reasonable duplicate of the proposed label.
If the label is being submitted for temporary approval, the actual label or copy of the actual label must to be submitted.
A printer's proof or copy of the sketch-approved label is not acceptable.
There are (up to) eight required features on the proposed label. These features are:
- product name,
- USDA inspection legend,
- net weight,
- handling statement,
- manufacturer's address (signature line),
- ingredients statement,
- nutrition facts, and
- safe handling instructions.
If the label includes other non-mandatory information, such as label claims, you may need to include supporting documentation
to verify that the claims or statements are validated.
For imported products that remain in their original packaging to retail, the country of origin needs to be placed directly under
the product name on the label.
The "sketch label" must include all the features that apply to your product. If the application is not accurate or
is missing something, it will be returned to you.
After you complete your application, review it for any errors. Simply taking an extra 10 minutes to review your label before
submitting it can save you a significant amount of time.
Listed below are the 10 most common mistakes that the FSIS Labeling and Program Delivery Division has found when reviewing label
applications.
- There are problems with ingredient statements.
- The formulation, processing procedure, or supporting documentation does not agree with, or validate, the information or claims on the label.
- The entire label is illegible or portions of the label are illegible.
- The label is incomplete because all required labeling features are not provided.
- Product standards are not met.
- The product name is incorrect.
- The word size of the product name is incorrect.
- A geographical claim is used on the label, but the product is not actually produced in the claimed location.
- There are problems with the nutrition facts.
- Undefined nutrient content claims are used.
After you review your application carefully, staple the completed FSIS Form 7234-1 and the "sketch label" together.
Two copies of both documents are required. (Three copies are needed for child nutrition labels.) Send the complete application package
to FSIS' Labeling and Program Delivery Division.
If you send the application through the U.S. Postal Service (including regular mail, U.S. Priority Mail, and U.S. Overnight Mail),
the package should be sent to:
USDA, FSIS, OPPD, LPDD
Labeling Distribution Unit
5601 Sunnyside Avenue, STOP 5273
Beltsville, MD 20705
If you send your label application via UPS or FedEx, or have it hand delivered by a company representative, the address is:
USDA, FSIS, OPPD, LPDD
Labeling Distribution Unit
5601 Sunnyside Avenue, Rm. 2-2279
Beltsville, MD 20705
If your label application is 15 pages or less, you can fax it to (301) 504-0873 or (301) 504-0875.
Contact USDA's Agricultural Marketing Service's (AMS) Child Nutrition Labeling Program if you are interested in marketing your
product to schools participating in the Child Nutrition (CN) program,
a voluntary program run by AMS, in cooperation with FSIS.
Having a CN label on your product ensures accurate nutrition claims and clearly identifies the nutritional contribution of a product
toward the AMS meal pattern requirements. The program also provides a warranty to CN programs that purchase CN-labeled products.
Products bearing the CN label offer greater potential for marketing to CN programs.
To carry a CN label, your product must be inspected by FSIS or your State inspection program. Also, your product's nutritional
contribution must be determined using yields set forth in USDA's Food Buying Guide for Child Nutrition Programs
(www.fns.usda.gov/tn/Resources/foodbuyingguide.html).
Upon applying, your product's formulation is evaluated to determine its nutritional contribution to school meals. This contribution
can then be stated on your label.
CN-labeled products are required to be produced under a partial quality control program to monitor formulation control, raw and
cooked weights, and other aspects of the formulation that affect the crediting of the product.
A CN-labeled product can cost a little more than a non-CN-labeled product because of inspection costs, special labeling requirements,
and additional quality controls. For more information, contact AMS at (202) 720-9939 or email CNLabeling@ams.usda.gov.
For questions and concerns regarding labeling, contact the Labeling and Program Delivery Division at (301) 504-0878 or submit your
questions to askfsis.custhelp.com. For all other inquiries, contact the Small Plant Help
Desk at 1-877-FSISHelp (1-877-374-7435) or email
InfoSource@fsis.usda.gov.
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Let the Small Plant Help Desk Help You!
By Ida Phillips
"If I sell chicken and pork products, can I ship them together in the same box?"
"How do I appeal a non-compliance record?"
"I just received a form in the mail from the USDA; can you help me understand it?"
These are just a few of the nearly 4,000 calls and emails received by the Small Plant Help Desk
since its launch in December 2009. The Help Desk, operated by the FSIS Office of Outreach, Employee Education, and Training's
(OOEET) State Outreach and Technical Assistance staff (SOTA) is a "one stop" call center where owners and/or operators of small
and very small plants can call (or email) about anything relating to the regulation of meat, poultry, and processed egg products.
All callers speak directly to an individual staff officer, who works one-on-one with the small and very small plant owner/operator
about their concerns. Often, the Help Desk staff will have materials or resources that can be sent to respond to a problem. In other
cases, the staff may have to research a question and call back with an answer.
In the 2 years that the Small Plant Help Desk has been available, many questions have been answered and many problems have been
alleviated. Mike Ardeljan, owner of Irish Valley Farms, a slaughter and pork sausage and smoked turkey processing plant, calls the
Help Desk regularly. "The Small Plant Help Desk is always responsive and fast with the answers to my questions. The operators are very
smart, and they are one of the only resources I ever use when I have a problem or a question," Ardeljan said. "When I need help, I
turn to the Small Plant Help Desk!"
The Small Plant Help Desk was established because feedback from owners and/or operators of small and very small plants revealed
that more assistance was needed to address concerns of these valuable stakeholders. Many small and very small plant owners expressed
concern that the agency wasn't as responsive as it could be to help the smaller establishments understand and comply with FSIS
regulatory requirements.
The Help Desk's staff officers enjoy one-on-one contact with callers and the opportunity to share their knowledge of FSIS'
organization, policies, and resources. According to Staff Officer Beth McKew, D.V.M., "Every one of us who answers the phone has
spent several years in the plant environment, so we understand the challenges out there." She adds, "Our goal is simple: to strengthen
small and very small plants by taking the time to help them understand regulations and other agency requirements. If we can't answer
their question, we make sure that we send them to someone who can."
Small and very small plants make up more than 90 percent of the 6,000 meat, poultry, and processed egg products establishments
inspected by FSIS. In addition to Federal plants, the Help Desk also supports State meat and poultry inspection programs and State
meat and poultry plants, all of which are small or very small businesses. Small and very small plants are vital to our economy and
food supply, and FSIS is committed to giving their operators the information and guidance they need to meet inspection requirements.
Ardeljan encourages his colleagues to utilize the Small Plant Help Desk whenever they are in need of assistance. "If you are
uncertain of something or just want clarification when the Web site is too confusing, just give the Help Desk a call," he said.
"They will find you what you need to know."
Let the Small Plant Help Desk assist you when you have a question or need guidance by calling 1-877-FSISHelp (1-877-374-7435) or emailing
InfoSource@fsis.usda.gov.
Staff officers are available from 9:00 a.m. to 4:00 p.m. ET, Monday through Friday.
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Commonly Asked Questions & Answers
Q. For the 2010 nutrition labeling final rule, is there a required format for the nutrition facts panel?
For example, can nutrition information be presented in script?
A. The nutrition facts panel format is regulated in 9 Code of Federal Regulations 317.309(c)-(f) and
381.409(c)-(f). Single-ingredient, raw meat and poultry products will qualify to use the simplified format in most circumstances.
Additionally, if the total square inches of labeling space (for the entire package) is less than 40 square inches, then the tabular
format may be used.
Nutrition information cannot be presented in script, however, because the regulations stipulate that letters in the nutrition
facts panel should never touch (9 CFR 317.309(d)(1)(ii)(D) and 381.409(d)(1)(ii)(D)).
Q. Will a full-service meat counter, where none of the meat is packaged until a customer selects
the product and then it is weighed and wrapped for the customer, have to comply with the 2010 nutrition labeling final rule?
A. Yes, if the full-service meat counter sells the major cuts of single-ingredient, raw meat and
poultry products listed in the nutrition labeling final rule, it will need to provide point-of-purchase materials for the
"major cuts" it sells. Ground product, unless it is ground at a customer's request, will require on-package nutrition facts
panels, unless the business qualifies for the small business exemption or other exemptions.
Q. With regard to the new cooperative interstate shipment program, can an establishment temporarily
employ more than 25 employees during the busy season if the average number of employees remains fewer than 25?
A. An establishment can temporarily employ more than 25 employees during the busy season if the average
number of employees remains fewer than 25, but it can not employ more than 35 individuals at any given time.
Example: For each 2-week pay period, an establishment that operates 3 months out of the year had the following number of
employees for each pay period (based on the standards for counting employees in 9 CFR 332.3(b) and 381.513(b)).
Pay Period 1: 23 employees
Pay Period 2: 30 employees
Pay Period 3: 31 employees
Pay Period 4: 25 employees
Pay Period 5: 20 employees
Pay Period 6: 10 employees
To verify that the establishment had the appropriate number of employees, add the number of employees for each pay period.
23+30+31+25+20+10=139
Divide that number by the number of pay periods.
139÷6= 23.2
The establishment has the appropriate number of employees to participate in the cooperative interstate shipment program because the
average number of employees is fewer than 25 and the number of employees for any given pay period never exceeds 35.
Q. Can States that do not have cooperative agreements for an "at least equal to" State meat
or poultry inspection (MPI) program participate in the new cooperative interstate shipment program?
A. No. The cooperative interstate shipment program is only available to those 27 States that have an
"at least equal to" State MPI program. States that do not currently have a State MPI program would need to first
implement a cooperative State MPI program before they could enter into a cooperative interstate shipment program agreement.
See FSIS Directive 5720.2 for the FSIS policy and procedures.
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Small Plant NEWS
Editor: Keith Payne
Managing Editor: Jane Johnson, DVM
Production: Joan Lindenberger, Sally Fernandez
Design: Gordon Wilson, Duane Robinson
Contact: Small Plant News, USDA/FSIS, Patriots Plaza III, Rm. 9-267A, Mailstop 3778,
1400 Independence Ave., SW, Washington, DC 20250
1-800-336-3747
Email: SmallPlantNews@fsis.usda.gov
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