Important Note: Previously, the annual report included data collected based on various fiscal year dates, all of which were based upon different date ranges.
- Good Manufacturing Practice (GMP) inspections, and the applicable violations, were reported for the period September 1 through October 31.
- Samples were reported for the period September 1 through October 31.
- Tonnage was reported for the calendar year January 1 through December 31.
- Licenses were reported from March 1 through the end of February (28/29).
- Bovine spongiform encephalopathy (BSE) and Food & Drug Administration (FDA) Medicated Feed License (MFL) inspections were reported from October 1 through September 30.
Beginning with this 2014 Annual Report, all Feed Program (except FDA contract work) data presented are on a calendar year basis, January 1 through December 31, using data from the 2013 calendar year. Food & Drug Administration (FDA) contract work is based upon the Federal Fiscal Year (FFY) 2013, which is October 1, 2012-September 30, 2013.
Wisconsin’s Feed Program assures consumers and manufacturers that animal feeds – livestock feed, pet food, and feed ingredients – are unadulterated, meet label guarantees, and are safe and effective for use. Program activities promote the safety of feed for livestock and companion animals, ensure the safety and integrity of the human food chain, protect consumers against fraud and deception, and support a fair and honest feed commerce environment under authority granted by Wisconsin Statutes 94.72 and Wisconsin Administrative Code ATCP 42.
In brief, the feed program issues licenses and feed export certificates of free sale, collects and audits tonnage reports and inspection fees, reviews labels for compliance with the feed regulations, collects and analyzes product surveillance samples, conducts inspections, handles education and training, and generates information to use during outreach activities with industry and consumers.
The department issued 1,298 commercial feed licenses for the 2013-2014 license year to firms that distribute, manufacture, process and/or label animal feed and/or feed ingredients in or into Wisconsin. Of these firms, there were 830 licensed facilities in Wisconsin, a 27.4 percent increase over 2012. A collective 4.6 million tons of commercial animal feed and feed products were distributed into Wisconsin during the calendar year 2013, a 1.2 percent increase from 2012. During February 2015, licensees are reporting tonnage information for the calendar year 2014. Chart 1 and Chart 2 summarize the overall feed program numbers during the calendar year 2013.
A feed export certificate of free sale or license card, indicating a feed license status, is sometimes required when feed products are exported internationally. To issue a certificate, the Department ensures the company is currently licensed with Wisconsin, located within Wisconsin, and is in good standing with the Department. In addition, the feed program ensures that all feed product labels listed on the certificate are in compliance with state and federal feed regulations. The department provides notarized license cards or notarized certificates of free sale for feed products, including livestock feeds, pet foods, feed additives and feed ingredients. During 2013, the department issued 305 certificates of free sale.
Compliance Activities and Special Projects The feed program monitors compliance through Good Manufacturing Practice (GMP) inspections. GMP inspections include a detailed review of the systems and practices utilized by feed manufacturing and processing firms. Adequate manufacturing systems and practices are essential in maintaining the safety and effectiveness of both medicated and non-medicated feeds, feed ingredients and pet foods. The inspection process evaluates facilities and equipment, as well as the firm’s receipt, use and distribution of feeds and feed ingredients. It also documents the firm’s manufacturing practices to ensure the manufacture of safe feeds.
In 2013, the department conducted 70 GMP inspections, with 23 inspections identifying significant violations; 67 percent of the inspected facilities were in full compliance with our regulations during the inspections. Environmental enforcement specialists issued 23 written warnings and 17 verbal warnings as a result of these inspectional findings. EE specialists are responsible for following up on compliance after issuing an inspected facility a warning, whether verbal or written. The significant violations included improper medicated feed labeling and failure to establish and maintain procedures for identifying, storing and controlling inventories of medicated feed ingredients.
The other activity used by the Department to monitor compliance is surveillance samples of feeds and feed ingredients. The samples are analyzed to determine if the feed or feed ingredient meets label guarantees. Samples may also be analyzed to detect the presence of contaminants, including heavy metals, pesticides, and microbiological contaminants.
In 2013, environmental enforcement specialists collected a total of 195 feed samples. Violations, such as failing to meet labeled guarantees, occurred in 94 samples, resulting in a 48.2 percent labeling noncompliance rate. The program is evaluating next steps to address this significant noncompliance rate and will be implementing outreach, increased surveillance in 2015, and possible enforcement options.
Preliminary sample results from 2014 samples show compliance in the feed sampling program improving over 2013. Still, it is important to note some categories of guarantees with an undesirable passing rate or a 0 percent passing rate. Chart 3 breaks down the sample analysis passes and fails by individual guarantee. Of significant concern is the high level of noncompliance related to medicated feed. Ideally, sample results would have more than 85 percent of samples meeting the guarantees to create consumer and regulatory confidence. Important notes about the breakdown:
- Amprolium and methionine have 0 percent passing rates.
- Protein has a 75.5 percent passing rate.
- Decoquinate has a 70.4 percent passing rate.
- Lasalocid has a 73.1 percent passing rate.
- Monensin has a 73.8 percent passing rate.
- Other guarantees not within expectation are ash, salt maximum, and vitamin A.
Industry Compliance Assistance As needed, EES and office staff assist industry feed manufacturers and labelers to better understand state and federal feed regulations. Topics addressed in meetings or through individualized assistance included common areas of violation such as properly labeling medicated and non-medicated feed products, and establishing and maintaining procedures to identify, store and control inventories of medicated feed ingredients. Feed program staff will monitor future inspections and industry inquiries to see if there is a need for further industry training or outreach focusing on certain areas.
FDA Inspection Contract Mills that use certain types of medications and antibiotics in feed products are required to hold a medicated feed license with the Food and Drug Administration (FDA). The FDA contracts with the Department to inspect these mills. We inspected seven of these mills in FFY 2013. FDA also contracted with the Department to inspect feed manufacturers for compliance with 21 CFR 589.2000 and 21 CFR 589.2001, which prohibit the use of certain animal protein in ruminant feeds. This federal regulation is commonly known as the bovine spongiform encephalopathy (BSE) feed ban. In FFY 2013, we completed 160 contract inspections. No violations or issues of concerns were noted.
Feed Investigations We also followed up on feed complaints and initiated investigations based on initial information collected during inspections. Complaints may originate from the Wisconsin Veterinary Diagnostic Laboratory (WVDL), the Division of Animal Health (within the department) or University of Wisconsin-Extension agents, but typically they come from private practice veterinarians and consumers. Generally, feed complaints are related to animal illness or death, potentially related to feed or feed products. In 2013, six complaints resulted in full feed investigations. All six of the investigations were closed as “insufficient evidence to demonstrate an adulterated feed source.”
Toxic Response The feed specialist serves as the Department’s coordinator for toxic response investigations. These cases involve illness or death of primarily food-producing animals from unknown causes. Alternatively, toxic response cases may result in the event of significant nonfood-producing animal deaths. In 2013, there was one toxic response activity involving 24 beef steers, resulting in 14 steer deaths. The Department cleared the feed of all suspicion related to the animal deaths and the focus of the toxic response was changed to pesticide exposure when the steers were suspected to have ingested the insecticide chlorphyrifos.
Homeland Security & Emergency Response Planning Feed program staff work with other Department personnel to implement, and keep current, response plans to protect the state’s animal industries from potential bio-terrorist attacks, radiological releases, natural disasters and foreign animal disease outbreaks.
Direction for the Coming Year
FDA Food Safety Modernization Act In January 2011, the federal Food Safety Modernization Act (FSMA) was signed into law. The purpose of FSMA is to prevent food-borne illness outbreaks. The FSMA includes new FDA authorities, new FDA responsibilities and activities, new food import requirements and an ambitious schedule for increased facility inspections. FDA issued draft FSMA regulations related to animal feed facilities in 2013. The draft rules were open for comment into 2014 with promulgation expected in August 2015. The proposed FSMA regulations represent a significant change from current regulatory expectations for industry. To date, it is not known what the final regulations will include and how the final rules will be implemented. This continues to be a priority issue with the department’s feed program. Upon the release of more information by FDA, the feed program will work with industry associations to create informational resources and conduct compliance assistance.
Feed Tonnage Updates Bureau, program staff, and industry volunteers worked together in 2014 to reduce the data collected on the Feed Tonnage and Inspection Fee Form, and to streamline the process. The new forms are in use beginning with the 2014 reporting year. The new form introduced a number of questions about reporting tonnage, to which the department drafted a question and answer document to address the questions. The document is posted on the department website.
Back to ACM Annual Report homepage.